101-O. Developing PROMIS-based research and clinical profiles for patients with heart
failure
Faraz S. Ahmad, Kathryn L. Jackson, Leilani Lacson, Susan E. Yount, Nan E. Rothrock,
Michael A. Kallen, Karl Y Bilimoria, Abel N. Kho, David Cella
All authors: Northwestern University Feinberg School of Medicine, Chicago, Illinois
Correspondence: Faraz Ahmad (faraz.ahmad@northwestern.edu)
Objectives
Heart failure (HF) is a common and morbid condition. We previously reported the development
of the PROMIS®-Plus-HF Profile Measure, a complete assessment of health that combines
generic and HF-specific items. To facilitate patient-centered research and care, we
sought to develop research and clinical profiles of the PROMIS-Plus-HF measure with
overall, physical, mental, and social summary scores.
Methods
Candidate items (n=31) for the Research and Clinical Profiles were selected from the
86 items in the PROMIS- Plus-HF Profile Measure based on psychometric properties and
to ensure coverage of the range of symptoms experienced by HF patients. In a web-based
survey, HF clinicians (n=43) rated item importance and clinical actionability. Informed
by these results, the study team developed a 27-item Research Profile and 10-item
Clinical Profile. Overall, physical, mental, and social health summary scores on a
scale of 0 to 100 were calculated. In a cross-sectional (n=600) sample, we measured
the reliability: internal consistency with Cronbach’s alpha and test-retest in sample
of 100 participants. Known groups validity was assessed using one-way ANOVA, modeling
difference in HF score across New York Heart Association (NYHA) Class and Kansas City
Cardiomyopathy Questionnaire (KCCQ) summary scores and subscales. Differences in change
in Profile scores (responsiveness) by KCCQ change was evaluated using linear mixed
regression.
Results
In the 600-person cross-sectional sample, the summary scores for the 27-item PROMIS-Plus-HF
Research Profile and 10-item Clinical Profile were normally distributed. Internal
consistency for domain scores were excellent (all α >0.8). Test-retest intraclass
correlation coefficients for domain and overall scores were ≥0.90. Both profiles demonstrated
known groups validity for overall score and physical sub-score based on NYHA Class,
and for all scores based on KCCQ groups (p<0.05). In the 75-person longitudinal sample,
the Research Profile demonstrated evidence of responsiveness (p<0.05) for the overall
and domain scores. For the Clinical Profile, the point estimates for the overall and
social and mental health scores reflected responsiveness and the change in physical
score reached statistical significance (p<0.05).
Conclusion
The PROMIS-Plus-HF Research and Clinical Profiles demonstrated overall good psychometric
characteristics. The PROMIS-Plus-HF Research and Clinical Profiles may be used to
facilitate patient-centered research and clinical care.
102-P. Withdrawn
103-P. Is there a difference in outcomes between patients treated with different implants
for hammertoe correction?
Amanda Holleran, Adolf S. Flemister, Benedict DiGiovanni, Irvin Oh, John Ketz, Gabriel
Ramirez, Caroline Thirukumaran, Judith F. Baumhauer
All authors are from University of Rochester Medical Center
Correspondence: Judith F. Baumhauer (Judy_Baumhauer@urmc.rochester.edu)
Objective
Hammertoe surgery is one of the most commonly performed musculoskeletal surgeries.
Thirty years ago, a simple 10 cents wire was used to stabilize the repair. In the
past 10-15 years a multitude of implants have been suggested to replace the simple
wire technique due to recurrence rates of the deformity. With new implants comes significant
cost increases. This study examines the physical function, pain, recurrent and other
complications of patients treated with 4 different surgical implants for hammertoe
correction.
Methods
A retrospective review of prospectively collected patient reported outcome measurement
information system (PROMIS) physical function PF and pain interference PI data was
performed in 248 patients who had a hammertoe correction January 2015-December 2019.
Categorical (yes/no) for recurrence and complications was obtained by chart review.
Mann-Whitney U, Chi-square test and mixed linear regression models for were used to
compare groups for demographics and assess PF and PI differences at final follow up
time point for each implant group (k-wire, nextra implant, retrograde fusion screw,
Trim it pin) correcting for confounding demographic variables.
Results
Baseline demographics demonstrated implants were used in slightly older aged patients
(2 years average). Other confounding variables included BMI (larger had lower PF),
Smoking history (past smokers had lower PF and higher PI), insurance (governmental
products had lower PF and higher PI). Implants had a higher recurrence rate (OR 1.9)
however no increase in other complications. At final follow up when controlling for
confounding variables, PF was better with nextra and trim-it pins than k- wire. There
was no difference in PI between K-wire and implant groups.
Conclusions
There is variation in the surgical implants used for the commonly performed hammertoe
procedure. The choice of implant should be based on patient reported outcomes (function
and pain improvement) as well as the risk of recurrence or complications. In this
case, the cost differential between the k-wire and the few implants reviewed is nearly
1,000 dollars. Objective assessments of outcomes will aid in determining value, eliminate
variation and improve the alignment of provider and health care cost allocation.
104-P. Is there a difference in outcomes between double or triple arthrodesis for
foot deformity?
Amanda Holleran1, Judith F. Baumhauer1, Jeff Houck 2, Daniel Homeier1, Adolf S. Flemister1,
Benedict DiGiovanni1, Irvin Oh1, John Ketz 1
1University of Rochester Medical Center; 2George Fox University, Newberg, OR
Correspondence: Judith F. Baumhauer (Judy_Baumhauer@urmc.rochester.edu)
Objective
Triple arthrodesis (fusion of the talonavicular, subtalar and calcaneocuboid joints)
has historically been considered the standard of treatment for arthritis of the hindfoot.
The complications of this surgery include non-union, malunion, nerve injury, infection,
and wound healing problems. Double arthrodesis (fusion of the talonavicular and subtalar
joints) is capable of producing a similar reduction in motion and correction of foot
deformity, however, may cause less patient morbidity due to one less joint being incorporated
into the fusion procedure and less cost due to shorter operative time and fewer hardware
needs. The purpose of this study is to evaluate the patient reported outcomes (PROMIS
physical function PF and pain interference PI) and complication rates for surgically
corrected foot deformity using a triple arthrodesis compared to using a double arthrodesis.
Methods
A retrospective review of prospectively collected patient reported outcome measurement
information system (PROMIS) data was performed in 57 patients who had either undergone
a double or triple arthrodesis from January 2015-December 2019. PF and PI scores were
collected. Linear mixed models were used to assess differences over time and between
groups (Double versus Triple) pre- operation, 3 months, 6 months, 9 months and 12
months post-surgery. Medical records were reviewed for complications (yes/no).
Results
There were no statistical differences between groups in terms of age (p=0.65), BMI
(p=0.32), pre-operative diagnosis (p=0.79), ASA rating (p=0.4), or complications (p=0.49)
occurred. Coefficient of variation at each time point per group varied from 11.9%
to 21.8%. Both groups were significantly improved in physical function (p<0.01) and
pain interference (p<0.01) without a significant difference between groups at 9 or
12 months.
Conclusion
Double arthrodesis can allow for similar correction of foot deformities without the
increased risk of wound complication and nonunion. Both groups demonstrated a significant
improvement in their PROMIS PF and PI at 1 year demonstrating either a double or triple
arthrodesis is a feasible operation however a double arthrodesis may potentially save
time and health care costs.
105-O. Methodology for selecting and evaluating items from PROMIS® Item Banks to develop
novel short-form questionnaires
Steven I. Blum1, Larissa Stassek2, Donald M. Bushnell2, Sejin Lee3, James W. Shaw1,
Mona L. Martin2
1Bristol Myers Squibb, Lawrenceville, NJ USA; 2Evidera | PPD, Bethesda, MD USA; 3University
of North Carolina, Chapel Hill, NC USA
Correspondence: Steven I. Blum (steven.blum@bms.com)
Objectives
PROMIS® measures can be administered via computer adaptive testing or through use
of existing short-forms and profile measures. Customized short-forms can be developed
by selecting items from PROMIS item banks. We describe a systematic approach for selecting
PROMIS items when creating custom short-forms and for generating evidence to support
content validity within specific patient populations.
Methods
A modified Delphi process was used to initially evaluate items from the PROMIS and
PROMIS-Cancer Physical Function items banks and to reduce the number of items to be
further evaluated in qualitative interviews. The Delphi panel (n=10) included both
measurement experts and patient representatives who evaluated the items using predefined
criteria and voted over three rounds to keep or drop each item. Retained items were
subsequently evaluated in combined concept elicitation/cognitive interviews. Interviews
(n=150) were planned with patients diagnosed with one of five different cancers (i.e.,
lung, renal, hepatocellular, melanoma, and head and neck). Interviews were conducted
at multiple sites in the United States and incorporated card sorting and rating exercises,
which facilitated discussion on the relevance and importance of each item and any
difficulty answering. The interviews were audio recorded, transcribed, and analyzed.
Results
The Delphi panel evaluated 169 PROMIS Physical Function items, voting to drop 93 and
retain 76 items for further evaluation in the qualitative interviews. While recruitment
is ongoing, preliminary results from the interviews have provided evidence for selecting
PROMIS items most relevant to patients with each tumor type. The final deliverables
will include a disease-specific short-form for each tumor type and an evidence dossier
suitable for submission to regulatory authorities. This methodology can be applied
to other measurement systems (e.g., EORTC, PRO-CTCAE) with item banks/libraries to
select subsets of items relevant to a specific target population.
Conclusions
Qualitative patient interviews incorporating card sorting and rating exercises can
be used to select a subset of items relevant to a specific population, while simultaneously
generating additional evidence to support content validity of the novel short-form
measures. A modified Delphi process helped to reduce the number of items that needed
to be evaluated, thus making the interviews more manageable and efficient.
106-P. PROMIS® Paediatric Self Report Profile-25 distinguishes subgroups of children
with two common paediatric knee injuries
Chaplin, J.E.1,2 Danielsson, A.3,4, Janarv, P-M.4,5,6, Askenberger, M.4,7
1Dept. of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg
University, Gothenburg, Sweden, 2Swedish Association of Local Authorities and Regions
(SALAR); 3Dept. of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy
at Gothenburg University, Gothenburg, Sweden; 4Swedish Paediatric Orthopaedic Quality
register (SPOQ); 5Capio Artro Clinic, Stockholm, Sweden.; 6Dept. of Molecular Medicine
and Surgery, Karolinska Institute, Stockholm, Sweden.; 7Dept. of Women’s and Children’s
Health, Karolinska Institute, Solna, Sweden
Correspondence: John Eric Chaplin (john.chaplin@gu.se)
Objective
To test the sensitivity of the generic PROMIS-25 and the child version of the illness-
specific measure Knee Injury and Osteoarthritis Outcome Score (KOOS-Child) to two
specific knee injuries which involve different symptoms and treatment regimens.
Methods
The qualitative control of treatment of severe knee injuries is followed by the Swedish
Paediatric Orthopaedic Quality register (SPOQ). All patients were invited to complete
paper versions of the two instruments at predefined follow-ups. Data collected in
2017–2019 are presented. Analyses were made of floor and ceiling effects. Agreement
between domains was tested using bivariate correlation. Sensitivity of injury and
treatment outcomes was investigated using a receiver operating characteristic (ROC)
curve.
Results
Data from 272 paediatric patients (49% female; mean age 13-years at follow-up, range:
9–14) were gathered. Diagnoses: patellar dislocation 43%; anterior cruciate ligament
injury (ACL) 22%; other diagnoses 33%; unknown 1%. The missing data rate was negligible:
PROMIS 0.4%, KOOS 1.6%. Ceiling effects were found in all KOOS variables. The highest
correlations between the domains of PROMIS (p) and the KOOS (k) were between ‘(p)mobility’
and ‘(k)sport’ (r=0.717), between ‘(p)pain interference’ and ‘(k)pain’ (r=0.634) and
between ‘(p)anxiety’ and ‘(k)QoL’ (r=-0.509). Sensitivity to diagnosis (patellar dislocation
and ACL) was more pronounced in PROMIS, where ‘(p)anxiety’ and ‘(p)mobility’ had the
largest AUC (0.5525 and 0.5461, respectively) of all domains in both instruments.
Conclusions
The expected agreements between similar domains in the two instruments were found.
Our results suggest that the PROMIS-25 was more sensitive to differences in anxiety
and mobility between different injury locations than the KOOS-Child. Further analysis
of the differences between these instruments will help to identify the measure of
first choice in registry data collection.
107-P. PROMIS® Paediatric Self Report and Proxy Profile-25 compared to a quality-of-life
instrument
Chaplin, J.E.1,2, Peterson, C.3, Danielsson, A4,5
1Dept. of Paediatrics, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg
University, Gothenburg, Sweden; 2Swedish Association of Local Authorities and Regions
(SALAR); 3School of Health and Welfare, Jönköping University, Jönköping, Sweden; 4Dept.
of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg
University, Gothenburg, Sweden; 5Swedish Paediatric Orthopaedic Quality Register (SPOQ)
Correspondence: John Eric Chaplin (john.chaplin@gu.se)
Objective
To compare the generic paediatric PROMIS profile-25 (p) with the multi-dimensional
quality-of-life instrument DISABKIDS-31 (d).
Methods
Paper versions were administered to children aged 8-17 years and their parents, and
to parents only for younger children, at the orthopaedic outpatient clinic of a university
hospital. PROMIS-25 is a six-dimensional PROM profile; DISABKIDS-31 is a five-dimensional
quality-of- life measure. Intraclass correlation coefficient assessed agreement between
child and proxy. Multiple linear regression was calculated to predict DISABKIDS total
QoL from the PROMIS profile for self-report and proxy-report. To visualize the relationships
between the variables, multidimensional scaling with PROXSCAL was used.
Results
Data on 35 children (4-17 yrs, 60% girls) were collected, which included 17 child/proxy
diads (9-17 yrs), 1 child (10 yrs) and 17 parent-reports without child self-report
(4-15 yrs). The most frequent reason for visiting the clinic (77%) was leg or muscle
injuries; other diagnoses included injury or deformity to the feet or back. Missing
data was negligible: PROMIS 3%, DISABKIDS 4%. There was good to excellent agreement
between child and parent DISABKIDS (r=0.673-0.903); poor to excellent for PROMIS (r=0.272-0.975),
with (p)peer relationships (r=0.272) having the lowest agreement. Predicting DISABKIDS
QoL scores, a significant regression equation was found for PROMIS self-report (F(7,9)=4,931,
p=0.015) with an adjusted R2 of 0.632, and for proxy-report (F(7,24)=14,608, p<0.001),
adjusted R2=0.54, with (p)physical function, (p)fatigue and (p)pain intensity being
reliable predictors (p<0.001, p=0.040; p=0.020, respectively). Multidimensional scaling
revealed a good separation between variables for both instruments, with the possible
exception of PROMIS anxiety and depression.
Conclusions
The two questionnaires demonstrated mixed inter-rater reliability, with PROMIS peer
relations having the lowest ICC, indicating a possible greater sensitivity to differences
in child/proxy reporting in PROMIS. A large part of the variation in DISABKIDS total-QoL
can be explained by the PROMIS profile scores, indicating overlap between the instruments.
The most reliable predictor of total-QoL was the physical functioning/mobility variable
in PROMIS. Multidimensional scaling suggests that PROMIS-25 has a better separation
between domains than DISABKIDS, with the possible exception of (p)anxiety and (p)depression.
Further analysis of the differences between these instruments would benefit from a
larger and more diverse population.
108-P. Patient-centered approach to response-level missing data
Chapman, R.
Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University,
Chicago, USA
Correspondence: Robert Chapman (Robert.Chapman@northwestern.edu)
Objective
To use mixture modelling as a patient-centered method to explain item-level missing
data in PROMIS measures. These methods are used to evaluate the presence of item missingness
across patient demographics, conditions and treatment, and patient-reported symptom
severity and impact. These results inform novel Missing Not at Random models of missingness
for PROMIS measures and help guide the clinician’s selection of PROMIS measures to
minimize patient non-response.
Methods
Data used in analyses were obtained from HealthMeasures Dataverse, including data
collected as a part of the development of the PROMIS Neuropathic and Nociceptive Pain
Quality measures. PROMIS measures were scored using IRT item parameters and pattern-
response scoring methods. Mixture modelling analyses were conducted with patient demographics,
clinical information, number of items missing and PROMIS T scores. All analyses were
conducted in R statistical computing software.
Results
Initial results with the PROMIS Neuropathic & Nociceptive Pain Dataset show that more
item- level missing data is associated with better neuropathic pain scores (as indicated
by lower PROMIS Neuropathic Pain Quality T scores) and with patients who have a condition
associated with nociceptive pain (rheumatoid arthritis & fibromyalgia). Conversely,
less missing item-level data is associated with worse pain (indicated by higher PROMIS
Neuropathic Pain Quality T scores) and with patients who have conditions associated
with neuropathic pain (diabetic neuropathy & cancer chemotherapy induced peripheral
neuropathy).
Conclusion
These results provide important guidance for researchers or regulators who may be
concerned about the item-level missing data in PROMIS measures: missing data is less
likely to occur with patients who have worse health-related quality of life (greater
symptom severity and impacts). Missing data is also less likely when patients are
answering items relevant to their condition or severity. Researchers seeking to model
item-level missingness for data imputation methods should focus on missingness in
patients with lower symptom severity and impact. These findings reinforce the importance
of administering item content relevant to the patient, which is appropriate to either
the patient’s condition or severity. Clinical users can incorporate these findings
into their practice by administering condition-relevant PROMIS short forms or by administering
PROMIS Computer Adaptive Tests to minimize irrelevant items.
109-P. Measurement of minimal disease activity in psoriatic arthritis using PROMIS-Physical
Function or the Health Assessment Questionnaire-Disability Index
Erin Chew1, 2, Jamie Perin3, Thomas Grader-Beck1, Ana-Maria Orbai1
1Johns Hopkins University School of Medicine Division of Rheumatology, Baltimore,
MD; 2Johns Hopkins Hospital. Baltimore, MD; 3Johns Hopkins University School of Public
Health, Department of International Health, Baltimore
Correspondence: Erin Chew, MD (echew6@jhmi.edu or erinychew@gmail.com)
Background
Minimal disease activity (MDA), is a treat-to-target strategy (T2T) objective in psoriatic
arthritis (PsA). MDA criteria include physical function, traditionally assessed via
the Health-Assessment Questionnaire Disability Index (HAQ-DI). It is of interest to
assess the performance of more current physical function instruments such as the Patient-Reported
Outcomes Measurement Information System-Physical Function Profile (PROMIS-PF).
Objectives
To assess the interchangeability of the HAQ-DI with the PROMIS-PF in the calculation
of MDA in PsA.
Methods
Longitudinal PsA data were collected including HAQ-DI and PROMIS-PF in a PsA cohort.
MDA definitions were built substituting the HAQ-DI criterion with the PROMIS-PF short
form 4a (PROMIS-PF4a) or with the PROMIS-PF computer adaptive test (PROMIS-PF Bank).
We assessed agreement/accuracy between HAQ-DI based and PROMIS-PF based MDA definitions
at each visit and longitudinally through the kappa statistic/ROC curve analysis.
Results
One hundred participants contributed 352 observations with up to five visits. Mean
(SD) age was 52 (12) years, 60% were female, and 43% were in MDA at baseline. Kappa
statistic for PROMIS-PF based MDA reflected almost perfect agreement with HAQ-DI MDA:
kappa=0.94 (95% CI 0.90-0.97) for MDA PROMIS-PF Bank and kappa=0.90 (95% CI 0.80-0.95)
for MDA PROMIS-PF4a. Higher longitudinal agreement was seen between MDA HAQ-DI and
MDA PROMIS-PF Bank versus MDA PROMIS-PF4a between consecutive visits: kappa ranged
between 0.81-0.94 versus 0.72-0.84, respectively (Table 1). Area under ROC curve for
predicting MDA HAQ-DI was 0.97 for MDA PROMIS-PF Bank and 0.95 for MDA PROMIS-PF4a.
Conclusions
Excellent agreement was seen between HAQ-DI and PROMIS-based MDA definitions statically
and longitudinally. The PROMIS-PF Bank and PROMIS-PF4a are accurate replacements for
the HAQ-DI in calculating MDA state in PsA.
110-O. Interpretation of PROMIS Fatigue CAT scores in solid organ transplant recipients
Sumaya Dano1, Ali Rezaeishahreza1, Areej Ali1, Nathaniel Edwards1, Setareh Aghamohammadi1,
Nasab El-Dassouki1, Jasleen Gill1, Marta Novak2, Susan J. Bartlett3†, Istvan Mucsi1†
†Susan J. Bartlett and Istvan Mucsi are co-senior authors
1Multi-Organ Transplant Program and Division of Nephrology, University Health Network,
Toronto, Canada; 2Centre for Mental Health, University Health Network, Toronto, ON,
Canada; 3Center for Health Outcomes Research, McGill University, Montreal, Quebec,
Canada
Correspondence: Istvan Mucsi (istvan.mucsi@utoronto.ca)
Objective
Relating PROMIS T-scores to functional impacts can help clinicians and patients to
meaningfully interpret T-scores. Here we assess the relationship between T-scores
vs the last items and responses in solid organ transplant recipients (kidney (KTRs),
kidney-pancreas (KPRs) and liver (LTRs)) using the PROMIS Fatigue Computer Adaptive
Test (CAT).
Methods
A cross-sectional, convenience sample of adult KTRs, KPR, and LTRs completed the PROMIS
Fatigue CAT on an electronic data capture system (DADOS, TECHNA Institute, UHN). The
number of items answered, and the unique last items administered from the PROMIS Fatigue
item bank were tabulated. Final T-scores were ordered from low to high, and last questions
and responses at different T-scores are reported.
Results
Of the 373 participants, the mean (SD) age was 53(14), 235 (63%) were male, 199 (53%)
were KTRs, 46 (12%) were KPRs and 128 (34%) were LTRs. T-scores were <50 (46%), 50-60
(35%), >60 (19%).A total of 18 unique last questions were completed in this study
sample. Patients with T-scores ranging from 24-40 had last questions and responses
that reflected no to very little fatigue. Unique last questions to this T-score range
included questions about strenuous exercise and feeling “sluggish”. Responses to these
questions suggested that patients were able to perform strenuous exercises and did
not feel tired. Patients with T-scores 60 had last questions and responses reflecting
moderate to severe fatigue. Unique last questions administered to patients with T-scores
60 included questions about fatigue interfering with physical functioning, and for
patients with T-scores >70, the ability to eat and carry a conversation. Responses
to questions in this T-score range suggested that fatigue limited the ability to perform
even basic daily activities of living.
Conclusion
We reported a relationship between PROMIS Fatigue CAT T-scores, and the last question
and response administered. This relationship can help improve the interpretation of
PROMIS Fatigue T-scores and help clinicians and patients understand how PROMIS Fatigue
T-scores relate to limitations in daily life.
111-P. Reducing questionnaire burden when screening for depressive symptoms in patients
with end-stage kidney disease
Sumaya Dano1, Evan Tang1, Faisal Jamil1, Dean Christidis1, Madeline Li3, Doris Howell4,
John Devin Peipert5, Susan J. Bartlett6, Istvan Mucsi1
1Multi-Organ Transplant Program and Division of Nephrology, University Health Network,
Toronto, Canada; 2Centre for Mental Health, University Health Network, Toronto, ON,
Canada; 3Department of Supportive Care, Princess Margaret Hospital, Toronto, Ontario,
Canada 4Princess Margaret Cancer Center, Faculty of Nursing, University of Toronto,
Toronto, Ontario, Canada; 5Department of Medical Social Sciences, Northwestern University
Feinberg School of Medicine, Chicago, Illinois; 6Center for Health Outcomes Research,
McGill University, Montreal, Quebec, Canada
Correspondence: Sumaya Dano (sumaya.dano@mail.utoronto.ca)
Objective
Routine screening for depressive symptoms can be time-consuming and burdensome for
patients. However, patients without depressive symptoms can be quickly screened out
using ultra-brief screening tools and avoid the need of completing more precise, but
longer, questionnaires. In this study we compare the questionnaire burden of completing
the Patient Health Questionnaire (PHQ9) or PROMIS Depression Computer Adaptive Test
(D-CAT) vs using various two-step screening combinations for depressive symptoms in
patients with end-stage kidney disease (ESKD).
Methods
A cross-sectional, convenience sample of adult kidney transplant recipients and patients
on maintenance dialysis completed the Edmonton Symptom Assessment Survey-revised (ESASr),
PROMIS D-CAT and PHQ9. PHQ9 score ≥10 was used as reference to identify moderate/severe
depressive symptoms. ESASr depression (ESASr-D) and PHQ2 score of ≥1 and ≥2 were evaluated
for the pre-screening step. In the second step, D-CAT T-score ≥55 was used to identify
patients with potentially significant depressive symptoms. The total number of questions
completed were calculated for the different scenarios.
Results
Mean(SD) age of the 164 participants was 52(17), 68% were male, 62% Caucasian. Based
on PHQ9, 16% (n=26) had depression. In the single step screening scenarios, the sample
would complete a total of 1476 PHQ9 or 1020 D-CAT items, respectively (9 or 6 items
per participant on average, respectively). All the different 2-step screening combinations
would reduce the total number of items completed by the total sample by at least half.
A 2-step method combining PHQ2 ≥2 and D-CAT (Sensitivity:65% Specificity:94%), required
a total of 510 items (both PHQ2 and D-CAT together; 3.1 per participant on average).
A 2-step screening combining ESASr-D ≥1and D-CAT (Sensitivity:58% Specificity:94%)
required a total of 435 items (both ESASr-D and D-CAT together; 2.7 per participant
on average).
Conclusion
Compared to administering either PHQ9 or PROMIS Depression CAT to all participants,
a 2-step process including an ultra-brief pre-screening tool reduced the number of
questions completed by the total sample substantially.
112-P. Psychometrics of three Swedish pediatric item banks from the Patient-Reported
Outcomes Measurement Information System (PROMIS)®
Frida Carlberg Rindestig1, Marie Wiberg2, Eva Henje Blom1, Inga Dennhag1
1Child and Adolescent Psychiatry, Department of Clinical Science, Umeå University,
Sweden; 2Department of Statistics, USBE, Umeå University
Correspondence: Inga Dennhag (inga.dennhag@umu.se)
Objective
The Patient-Reported Outcomes Measurement Information System (PROMIS®) aims to provide
self-reported item banks for several dimensions of physical, mental and social health.
Here we investigate the psychometric properties of the Swedish pediatric versions
of the item banks for pain interference, fatigue and physical activity.
Methods
12-19 years old participants (n = 681) were recruited in public school settings, at
a child- and psychiatric outpatient clinic, and a youth health outpatient clinic confirmatory
factor analyses (CFA) were performed to evaluate scale dimensionality and local dependence.
Item Response Theory (IRT) analyses were then used to finalize item banks and assure
that each item is valid and weighted as a standalone assessment.
Results
CFA results confirmed that pain interference, fatigue and physical activity are separate
constructs. Items with low item fit and items with Differential Item Functioning (DIF)
were removed resulting in 14 items of pain interference and 15 items of fatigue items,
and 6 items of physical activity.
Conclusions
Swedish Item banks were developed to assess pain interference, fatigue and physical
activity in 12-19 year olds by using item response theory. These instrument offers
precise, efficient and flexible assessment and allow researchers to select only the
most useful items to study.
113-P. Parental caregiver burden and recovery of adolescent Anorexia nervosa after
multi-family therapy
Inga Dennhag, Eva Henje Blom, Karin Nilsson
All authors: Child and Adolescent Psychiatry, Department of Clinical Science, Umeå
University, Sweden
Correspondence: Inga Dennhag (inga.dennhag@umu.se)
Objective
Parental involvement in the treatment of anorexia nervosa has shown to be extremely
important, especially for adolescents. This study investigated whether parental caregiving
burden changed during adjunct multi-family therapy of adolescent anorexia nervosa
and eating disorders not otherwise specified (EDNOS) and whether caregiver burden
at baseline and changes in caregiver burden during treatment were associated with
treatment outcome.
Methods
Twenty-four females, 13 to 16 years old, and their parents, participated in the study.
Caregiver burden was measured with the Eating Disorders Symptom Impact Scale, by mothers
(n=23) and fathers (n=22). Treatment outcome was measured by adolescent body mass
index, level of global functioning and self-rated eating disorder symptoms by the
Eating Disorders Examination Questionnaire 4.0.
Results
All patient outcomes improved and overall caregiver burden decreased significantly
during treatment. When broken down in aspects of caregiver burden the decrease in
parental perceived isolation, was found to be associated with improvement of BMI and
Children’s Global Assessment Scale. When analyzing fathers and mothers separately,
we found that maternal feelings of guilt and paternal perceived burden of dysregulated
behaviors at base-line were correlated to treatment outcome.
Conclusions
Multi-Family Therapy shows preliminary effectiveness as an adjunct treatment for anorexia
nervosa and eating disorders not otherwise specified. Fathers might be more important
than seen before in treatment, especially in the participation of Multi-Family Therapy.
Caregiver burden can be a potential mediator of treatment results in the future.
114-P. Measuring function in a multidisciplinary Osteogenesis Imperfecta clinic
Maureen Donohoe, Cristina McGreal, Jeanne M. Franzone, Richard W. Kruse, Michael B.
Bober, Kenneth Rogers, Robert Wellmon
All authors: Nemours/ Alfred I. duPont Hospital for Children, Wilmington, DE
Correspondence: Maureen Donohoe (Reenee.Donohoe@nemours.org)
Objective
Our objective is to report on early results of data collected during multidisciplinary
clinic visits using PROMIS, functional mobility scores (FMS), and BMI, identifying
relationships between type of Osteogenesis Imperfecta (OI) and function.
Methods
This is a single center retrospective review of OI patients attending a clinic visit
including Genetics, Orthopaedics, and Physical Therapy between January, 2016– October,
2019. Demographic, clinical, operative data, PROMIS dimensions including physical
mobility, upper extremity function, pain interference, fatigue, and peer relationships
(pediatric) or social participation (adult) and FMS were collected. Individuals’ presentations
were sorted by mild, moderate, or severe and by BMI into categories of ideal, overweight,
and obese.
Results
49 met criteria and were grouped based on OI severity. OI severity was associated
with higher BMI and lower levels of function on PROMIS Physical Mobility and Upper
Extremity Function dimensions. BMI was negatively associated with PROMIS Physical
Mobility score. Individuals with OI who scored higher on PROMIS Physical Mobility
and Upper Extremity Function had lower levels of Pain and Fatigue based on reported
scores. Statistical significance between group differences for BMI, and PROMIS scores
for Physical Mobility and Upper Extremity Function. Participants with mild or moderate
OI severity had significantly lower BMI than those with severe OI. PROMIS Physical
Mobility: participants with mild and moderate OI had significantly higher scores than
those with severe OI; individuals with mild OI also scored significantly higher than
those with moderate OI severity. PROMIS Upper Extremity Function: participants with
mild OI had significantly higher scores than those with moderate or severe OI.
Conclusions
Patient reported outcome (PRO) measures are helpful in understanding individuals’
functional levels and identifying needs. Mild OI presentation tend to have lower BMI
and greater activity as noted on PROMIS. Fatigue and Pain Interference on PROMIS did
not have a significant relationship based on severity of OI or BMI. Severe presentation
of OI tend to have higher BMI and less physical activity and upper extremity function
on PROMIS. Past year fracture history, surgical intervention, and bisphosphonate use
had no statistically significant impact on PRO across this population.
115-O. Cross-walking PROMIS-29 to the Roland-Morris Disability Questionnaire and Oswestry
Disability Index for chronic back pain
Maria Orlando Edelen1, Anthony Rodriguez1, Patricia M. Herman1, Ron D. Hays1,,2
1RAND, 2UCLA
Correspondence: Maria Orlando Edelen (orlando@rand.org)
Objective
There is extensive literature on the effectiveness of pharmaceutical and nonpharmacologic
interventions for chronic low back pain (CLBP) based on different samples and outcome
measures. The NIH Research Task Force (RTF) on CLBP noted that these differences make
it difficult to compare studies of similar or competing interventions. These differences
limit the usefulness of the results in answering questions such as ‘Which therapies
work best? And for whom?’ This study reports empirical links of the PROMIS-29 with
the Roland-Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index
(ODI) to enable comparisons across more studies.
Methods
Secondary analyses of three datasets: 1) RAND Center of Excellence for the Appropriateness
of Care (CERC) data (n=1677) were collected on chiropractic patients being treated
for CLBP and CNP; 2) Assessment of Chiropractic Treatment for Low Back Pain (ACT)
data (n=750) were collected on active military personnel participating in chiropractic
clinical trials for LBP; and 3) Amazon Mechanical Turk (MTurk) data were obtained
from a general population sample (n=5755) that included a subgroup that reported CLBP
(n=1444). The PROMIS-29 was administered in all three datasets, the RMDQ in the ACT,
and the ODI in the CERC and MTurk datasets. We develop ordinary least squares regression
equations to predict the RMDQ and the ODI from PROMIS-29 scales.
Results
R
2
values ranged from 54 to 61% with normalized mean absolute error (NMAE) ranging from
0.51 to 0.53 standard deviations in regression models predicting the RMDQ from the
PROMIS-29. Physical function, pain interference, and sleep disturbance were consistently
retained. R
2
values ranged from 65 to 67% in CERC data and 63% in MTurk data with NMAE ranging
from 0.43 to 0.47 in CERC and 0.46 in MTurk data for predicting the ODI. Physical
function, social function, sleep disturbances, and average pain intensity were consistently
retained.
Conclusions
The RMDQ and ODI “legacy” scores can be predicted from the PROMIS-29 with sufficient
accuracy for group-level comparisons. These crosswalks enable comparisons of studies
that use legacy measures with those that administer the PROMIS-29. In addition, these
results can be used for the harmonization required for individual patient data meta-analyses.
116-O. Dutch reference values for the PROMIS Scale v1.2 – Global Health
Ellen BM Elsman1, Leo D Roorda2, Martine HP Crins2, Maarten Boers1, Caroline B Terwee1
1 Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics,
Amsterdam Public Health research institute, Amsterdam, the Netherlands 2 Amsterdam
Rehabilitation Research Center | Reade, Amsterdam, the Netherlands
Correspondence: Ellen Elsman (e.elsman@amsterdamumc.nl)
Objective
In order to add context to the health impact of diseases and conditions, it is important
to interpret and compare patient-reported outcomes across studies and populations.
This study aims to estimate and evaluate Dutch reference values for the Patient- Reported
Outcomes Measurement Information System Global Health (PROMIS-GH) scale.
Methods
The PROMIS-GH v1.2 was administered through a web-based survey to 4370 Dutch persons,
representative for the Dutch general population in 2016. T-scores for the mental health
(GMH) and physical health (GPH) subscales, and their shorter two-item subscales, were
calculated for the entire population, age groups and gender. T-scores for GMH and
GPH were compared to the US reference population, which has a mean T-score of 50 and
a standard deviation of 10, and to age-range and gender subpopulation reference scores.
US reference population T-scores are representative for the 2000 US general population.
Results
The Dutch population had a GMH T-score of 44.7 and a GPH T-score of 45.2, both substantially
lower, and thus worse, than the US reference population T-score of 50. Lower T-scores
for the Dutch general population were found for both age-range and gender subpopulations
compared to US subpopulation reference values. T-scores of the Dutch general population
showed a similar pattern compared to US reference values: T-scores worsened with increasing
age, but improved again for the oldest age groups; males scored better than females.
Conclusions
This study reports reference values for the PROMIS-GH scale for the Dutch general
population, including age-range and gender subpopulations. PROMIS can improve the
assessment of physical and mental health, but appropriate population reference values
are essential for their interpretation. This study provides these values for the Netherlands;
they are notably worse from the US reference values of 2000; perhaps the US data is
outdated and no longer representative of the current US health status. Nevertheless,
this study fuels the discussion on whether or not we should anchor the mean and standard
deviation of PROMIS scales on the US population.
117-P. PROMIS in English speaking countries – A systematic review of the evidence
for measurement invariance of PROMIS tools
Alex Matthews, Jonathan P Evans, Jose Valderas
All authors: Health Services and Policy Research Group, University of Exeter Medical
School, Exeter, UK
Correspondence: Jonathan P Evans (j.p.evans2@exeter.ac.uk)
Objective
Measurement invariance across different populations defined in terms of language and
culture must be quantified and confirmed to ensure that Patient Reported Outcome Measures
(PROMs) maintain their metric properties. The Patient Reported Outcomes Measurement
Information System (PROMIS) was designed and tested on a US reference population.
Assumptions of validity and cross-cultural equivalence in other English-speaking countries
is based on a universal translation approach, but remains untested and should be confirmed
alongside evaluation of other psychometric properties such as reliability and responsiveness.
We aimed to investigate the use of PROMIS instruments in non-USA English speaking
countries, and the evidence of measurement invariance within these populations.
Methods
We performed a systematic search of MEDLINE and Embase for contemporary literature
from 2017 onwards. Articles were included if they provided evidence of use or assessment
of metric properties of PROMIS instruments in UK, Australian or New Zealand populations.
Secondary searches of published abstracts from conference proceedings and trial registries
were also undertaken.
Results
Twenty-two articles met our inclusion criteria and 12 (55%) used a PROMIS instrument
as an outcome measure without any evaluation of their metric properties in the target
populations. The remaining 10 articles analysed the metric properties of PROMIS tools.
Six Australian psychometric analyses focused on mental health metrics for the Depression,
Anxiety and Emotional Distress item banks. Three studies provided evidence to support
validity, responsiveness to change was confirmed in two and measurement invariance
was assessed in one. Only four studies including UK populations studied either the
validity, responsiveness or invariance. Sixty-nine registered clinical trials were
identified. The majority planned to use PROMIS tools to assess outcomes. There was
no evidence of cross-cultural adaptation or testing for cross-cultural equivalence
of PROMIS item banks.
Conclusion
Evidence on the measurement properties of PROMIS instruments in populations from English
speaking countries outside of the US and Canada is sparse. Lack of confirmation of
measurement invariance places the interpretation of PROMIS instruments at risk. There
is a pressing need for the evaluation of cross-cultural validation amongst English
speaking populations to ensure appropriate interpretation and acceptance of the PROMIS
instruments.
118-O. Monotonic polynomials to model flexible item response curves for PROMIS Physical
Function
Carl F. Falk1, Felix Fischer2
1Department of Psychology, McGill University, Montréal, Québec, Canada; 2Department
of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité –
Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität
zu Berlin, and Berlin Institute of Health, Berlin, Germany
Correspondence: Felix Fischer (felix.fischer@charite.de)
Objective
The PROMIS Instrument Development and Validation Scientific Standards suggest to investigate
each items’ measurement properties by inspecting initial probability functions from
non- parametric IRT models. Typically, items are excluded when their response function
is misfitting a parametric model. Monotonic polynomials allow to parametrically model
aberrant response curves and therefore to retain such items in the measurement model.
We investigated suitability of this approach in the PROMIS Physical Function item
bank.
Methods
Using PROMIS Wave 1 data (N = 15,725) for Physical Function, we fitted a monotonic
polynomial model as well as the standard graded response model. We compared both models
in terms of overall model fit, latent trait estimates, and item as well as test information.
We investigated item-level differences between both models using common measures of
differential item functioning and simulated the impact of model differences on scoring
of 5 and 10 item tests.
Results
The monotonic polynomial showed better fit to the data indicated by a significant
likelihood ratio test and a lower AIC (but higher BIC) compared to the graded response
model. The difference of theta estimates between both models was less than 0.12 in
95% of the cases, but the monotonic polynomial model had higher information in the
lower ranges of the construct. The high concordance between both models could be due
to the fact that items with aberrant response curves have not been included in the
PROMIS Physical Function itembank.
Conclusions
Monotonic polynomials as flexible intermediates between parametric and non- parametric
models appear to be a useful addition to PROMIS developers’ toolbox.
119-P. Development and pilot testing a self-reported pediatric PROMIS app for young
children aged 5-7 years
Wenjun Gao, Changrong Yuan, Yuchen Zou, Huan Lin
all authors: School of Nursing, Navy Medical University, Shanghai, China.
Correspondence: Wenjun Gao (zerowenjun@163.com)
Objective
The aims of this study are threefold. Firstly, using the state of science PROMIS (Patient-Reported
Outcomes Measurement Information System) methods to develop a smartphone application
to monitor the emotional distress for young children aged 5-7 years old; Secondly,
to test the usability of this application; and thirdly, to determine the level of
agreement between reports by parents and young children's self-report.
Methods
A multidisciplinary research team, made up of senior pediatric nurses and doctors,
software engineers' team, and pediatric health researchers worked together to develop
this application. Three phases of stakeholders and user studies were conducted. Phase
1 focused on prototype development; Phase 2 involved cognitive interview and usability
testing; Phases 3 focused on the pilot testing of this application.
Results
We included the original parent proxy reporting version of Patient Reported Outcome
Measurement Information System-emotional distress in the application, as well as self-
reporting animated version for young children. After many rounds of modification,
all participants felt that this application was easy to use and the animated items
were easy to understand for young children aged 5-7 years. Correlations between parents-children
reports are significant and moderate, parents underestimated child depression, and
overestimated child anger and anxiety compared to child self-report.
Conclusions
This smartphone application and its Web-based administration portal demonstrate good
usability and are well accepted by young children aged 5-7 years, which can be used
to promote young children's participation when reporting or assessing symptoms of
young pediatric patients. Parent reports cannot be substituted for child reports and
evaluations of pediatric patients' perspectives regarding treatment outcomes should
be included in pediatric clinic. This animated application can be used as a smart
measurement to investigate the symptoms for young children aged 5-7 years, so as to
amplify young children's voice in clinical care.
120-P. Difficulties in conducting online surveys among children and adolescents using
translated Short Form of the PROMIS Ped SF v2.0 – Depressive symptoms 8b and modified
Korovessis questionnaire
Emilia Wołyniec 1, Bożena Glinkowska.2, Wojciech Glinkowski 3,4,5
1Department of Rehabilitation, Medical University of Warsaw, Poland; 2Department of
Sports and Physical Education, Medical University of Warsaw, Poland; 3Polish Telemedicine
and eHealth Society, Warsaw, Poland; 4Center of Excellence "TeleOrto" for Telediagnostics
and Treatment of Injuries and Disorders of the Locomotor System, Medical University
of Warsaw, Warszawa, Poland; 5 Polish PROMIS National Center, Warsaw, Poland
Correspondence: Wojciech Glinkowski (w.glinkowski@gmail.com)
Introduction
Surveys are one of the basic and commonly used measuring tools to describe the phenomenon
of interest to us. A quick and straightforward to implement online form facilitates
and shortens the time of the entire process. Tests and research instruments must meet
the criterion of reliability. The study aimed to determine the difficulties that should
be considered in conducted surveys among children and adolescents based on questionnaires
about body posture, physical activity, back pain, and symptoms of depression.
Aim of the study
The research was carried out at randomly selected schools in Warsaw and Tczew. The
study involved 85 teenagers attending elementary school classes.
Material and methods
The study was conducted in 2 groups (32 participants - average age 12.3 years and
53 participants average age 11.8 years). The study was conducted using the internet
"mini-questionnaire" http://mini-ankieta.azurewebsites.net/ with the consent of the
Bioethics Committee. In both groups, the study was conducted twice, with the second
one after a one-week break, as recommended for the reliability studies. The questionnaire
consisted of 53 items. Questions include data on age, weight, and height as well as
on carrying a backpack/school bag, school and sports activity, and the presence of
posture defects (Korovessis, Glinkowska). Besides, the PROMIS Ped SF v2.0 – Depressive
Symptoms 8b (eight items) was used to assess the participants' mood for back and neck
pain. The groups differed in information resources during the procedure of signing
informed consent (standard vs. enriched with additional instructions and introduction
to the problem of back and neck pain and problems with posture). Retest test reliability
testing was performed, and Cronbach's alpha values were calculated using Medcalc version
19.1 software.
Results
In both groups, reliability in the questions asked sex, body build, and basic data
from everyday life (e.g., backpack weight, number of hours spent on various school
activities and outside school) showed good Cronbach's alpha results (> 0.7). In the
group in the standard procedure, Cronbach's alpha values were insufficient (from 0.1
to 0.56), especially questions about sadness, weakness, fatigue, and exhaustion. Student
information about themselves was highly consistent (Height - alpha 0.97; Weight 0.86).
In the second group, data from 53 students about themselves were good - Cronbach's
alpha> 0.7.
Discussion
The too-short range of information provided before testing among children and adolescents
may result in low compliance of the responses in the test-tester, which could affect
the reliability of the research instrument. Analysis of potential causes suggests
that among the reasons there may have been motivational problems for the scrupulous
and faithful answering of questions by children and adolescents.
Conclusions
Research confirms the need to inform children accurately and young people about issues
related to surveys; otherwise, there is a risk of unreliable research.
121-O. Feasibility using PROMIS-CAT in a sports medicine center and regenerative medicine
registry in outpatient setting
Marc Gruner, Mark Nyman, Kelsey Wolff, Jacob Sellon, Karina Gonzalez
All authors: Mayo clinic Rochester, MN
Correspondence: Marc Gruner (grunerm@gmail.com)
Background
PROMIS-CAT is a patient reported outcome (PRO) tool used to assess the health status
of patients. Prior to working on this pilot, many challenges existed for PRO collection.
For example, patients coming to the sports medicine center, there were no universal
PRO. Additionally, a regenerative medicine registry existed at the sports medicine
center for ambulatory procedures via third party software (TPS). The regenerative
registry had a low percentage follow-up outcome response and select providers were
able to utilize the registry. This pilot aimed to evaluate the completion rate of
PROMIS questionnaires among patients presenting for outpatient evaluation to the Sports
Medicine. A second aim was to compare the completion rate of follow-up data of PROMIS/Epic
data implementation to legacy measures/TPS.
Methods
PROMIS-CAT was implemented via the EHR using patient online services (POS) portal.
The first aim consisted of collecting PROMIS-CAT Pain Interference (PI) and Physical
function (PF) as the instruments for measuring outcomes on all patients coming to
the sports medicine center. The second aim consisted of autonomously identifying ICD-10
codes prior to a regenerative procedure as lower body vs. upper body procedure. For
a lower body procedure, PROMIS-CAT PI/PF was used. For an upper body procedure, PROMIS-CAT
PI/UPF was used. Baseline and Follow up outcome measures were sent after a procedure
at 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Results
A review was performed monthly to assess evaluation of the first aim. 728/1028 patients
seen in the Sports Medicine center completed PROMIS measures during one month for
a completion percentage of 76%. A second aim was comparing regenerative registry data
after a procedure via PROMIS/EHR to legacy measures/ TPS. At baseline, 95% of patients
completed PROMIS measures to 83% for TPS. Six week data had 61% completion percentage
of PROMIS compared to 52% of TPS. At 3 months, 53% completed PROMIS measures compared
to 43% TPS. The PROMIS registry collected 57 procedures compared to 7 in the TPS during
a three-month review.
Conclusion
EHR linked PROMIS had higher completion rates and allowed for tracking of significantly
more procedures than the TPS. Using PROMIS-CAT via the EHR for registries can improve
capture rate.
122-P. Digital application was superior to physical therapy for orthopedic knee injuries
assessed by PROMIS® measures
Marc Gruner, Jacob Sellon, Ike Hasley, Jared Hoffmann, Karina Gonzalez
All authors: Mayo Clinic Rochester, MN
Correspondence: Marc Gruner (grunerm@gmail.com)
Background
Knee pain is one of the most prevalent musculoskeletal disorders in the US. Physical
therapy (PT) is often the initial treatment for conservative care. Efficacy of a PT
exercise program delivered via a digital application (Limber Health app) compared
to standard PT has not been thoroughly assessed. The use of PROMIS® measures for PT
in orthopedic knee injuries is limited. The aim was that Digital Home-Exercise Therapy
Application (DETA) will be superior to the standard of care (PT) after 8 weeks with
respect to improvement in PROMIS® pain (PI) and function (PF) Computerized Assessment
Test (CAT) measures.
Methods
This was a multi-center, prospective; single-blind randomized clinical trial comparing
PT to DETA. A total of 60 patients prescribed PT were randomly assigned. The PT groups
were assigned to therapy twice a week for 8 weeks. The DETA group was assigned to
15-25 minute videos 3 times a week for 8 weeks that were tailored based on the patient’s
disability and health status. The DETA’s algorithm adjusted the intensity of DETA’s
program progression based on results from a 4-week interim follow-up measuring changes
in PROMIS® scores. The primary outcome was change in PROMIS® scores. Patients were
reviewed at baseline and at 8 weeks.
Results
Thirty patients completed the 8 week intervention (17 control, 13 treatment) at the
time of submission. No differences existed between the groups in age or gender (p>.05).
Preliminary analysis suggests changes in PI (control: -1.8±7.8, Limber app: -6.3±6.7)
and PF (control: 0.46±6.6, Limber app: 5.7±7.0). Independent t-tests revealed absolute
changes in PROMIS Physical Function were significantly greater in the DETA group compared
with control, indicating a greater improvement in function; a large effect size was
noted (p<.05, Hedge’s g = 0.77). Changes in Physical Function and Pain Interference
surpassed MCID in the Limber group, but not in the control group.
Conclusion
An 8-week DETA program was superior to the standard of care of PT program at the time
of submission. The study supports that a DETA could have similar outcomes with respect
to pain and function compared to PT. This study describes an innovative approach to
risk stratify patients to appropriate exercise based off of their disability.
123-P. PROMIS and PROs in the Symptoms System - Visualizing health in clinical care
Emelie Gustafson1, Martin Wohlin1, John Eric Chaplin2
1Uppsala University, Uppsala, Sweden; 2 University of Gothenburg, Gothenburg, Sweden
Correspondence: Emelie Gustafson (emelie.gustafson@symptoms.se)
OBJECTIVES
This presentation will explore means to: Equalize asymmetry between needs and expectations
in health care using patients’ perceptions about symptoms, functions and quality of
life; Balance knowledge and preferences in point-of-care interactions, leading to
better outcomes and enhanced value in health care; Impower patients to take responsibility
for quality of care with scientifically based methods to contribute to safer, more
efficient and equal care; Implement PROMIS and other PROM instruments in a patient-driven
digital system, where the combination and visualization of PROMIS measures together
with other PROMs facilitates usage, with benefits for both clinical care and patients.
METHODS
An evaluation protocol designed according to universal and co-design principles will
be described. This will explore how to visualize results and combine PROMIS measures
with other PROs, facilitate long-term implementation, support patient empowerment,
self- management, and improve clinical care. A mixed-methods approach will be used
to explore patient and multidisciplinary perspectives on the visualization of data,
and the feasibility of implementation in clinical care and for patient self-management.
RESULTS
Measuring patient reported outcomes (PROs) with standardized questionnaires is a scientifically
sound method to gain insight into patients’ symptoms, functions and quality of life.
In certain contexts, PRO collection has been linked to increased survival, improved
symptom management, and good treatment results in randomized studies. PROMIS provides
a set of person-centered measures that evaluates and monitors physical, mental, and
social health. With its generic approach, and possibilities for modern methods of
administration, it offers great advantages over historical paper questionnaires and
facilitates use at many stages both for clinical care and patients. This protocol
will explore how to combine and visualize PROMIS measures together with legacy questionnaires.
Processes to visualize data for patients as well as clinicians, while upholding the
quality of the data collected, will be explored. In the presentation we will illustrate
the visualizations tested.
CONCLUSIONS
Equalizing asymmetry between needs and expectations of PROs visualization for clinicians
and patients requires careful consideration of the overall purpose of the data and
health management.
124-P. Do PROMIS measures correlate with fitness and satisfaction with social roles
in participants of a university wellness clinic?
1Jeff Houck,1Dan Kang, 2Mary Imboden
1School of Physical Therapy, George Fox University, Newberg, Oregon; 2School of Exercise
Science, George Fox University, Newberg, Oregon
Correspondence: Jeff Houck (jhouck@georgefox.edu)
Objective
Studies determining the concurrent validity of patient reported outcomes and performance
outcomes are useful for application to clinical care. To determine the correlation
(bivariate and multivariate) between a set of biopsychosocial PROMIS measures with
1) physiologic measure (VO2 Max) of fitness and 2) Satisfaction with Social Roles
in attendees of a University Wellness Clinic.
Methods
From January to March 2020, 44 of 58 attendees (age=23.7±9.6 y.o., VO2 max=42.6±8.3
ml/kg/ml) of a University Wellness Clinic completed PROMIS computer adaptive tests
(physical function [PF], pain interference [PI], fatigue, self-efficacy [SE] of managing
emotions, SE of managing social, anxiety, depression and satisfaction with social
roles[SSR]) and short forms (SE of daily activities [SF8]) in addition to physiologic
testing (i.e. VO2 Max). Univariate correlations and multivariate linear analysis were
used to assess the convergence of age, gender, and different PROMIS measures with
1) VO2 max and 2) PROMIS SSR.
Results
Age (r= -0.31, p=0.02), PF (r=0.46, p<0.01) and fatigue (r=-0.40, p<0.01) showed significant
univariate convergence with VO2 max. Younger age, higher physical function and lower
fatigue correlated with higher VO2 max values. A multivariate model including age
(p=0.05), PROMIS PF (p=0.05), fatigue (p<0.01), and PI (p=0.04) resulted in a r-value
of 0.62 for predicting VO2 max. Age (r= -0.40, p<0.01), PROMIS PF (r=0.44, p<0.01),
PI (r=-0.44, p<0.01) and SE daily activities (r=0.35, p=0.02) showed significant convergence
with SSR. Younger age, higher physical function, lower PI and higher SE with daily
activities correlated with higher SSR values. A multivariate model including PROMIS
PF (p<0.01), depression (p=0.05), and SE of emotions (p=0.02) resulted in a r-value
of 0.56 for predicting SSR.
Conclusions
Perceptions of function detected by PROMIS measures associated with physical health
rather than psychosocial health show better convergence with fitness in mostly younger
people attending a Wellness Clinic. In contrast, measures of physical health (PF)
and mental health (depression and SE emotions) showed convergence with satisfaction
with social roles. These outcomes support the use of PROMIS measures of physical health
to counsel young participants seeking to improve fitness and a combination of physical
and mental health measures when focusing on social roles.
125-P. Is unacceptable self-efficacy associated with unacceptable physical health
domain function and symptoms?
Houck, Jeff,Kang, Dan, Philbrook, Li-Zandre, Jacobson, Ryan
All authors: George Fox University, Newberg, OR, United States
Correspondence: Jeff Houck (jhouck@georgefox.edu)
Objective
Interpretation and application of the Patient-Reported Outcomes Measurement Information
System (PROMIS) Self-Efficacy for Managing Symptoms (SEsx) for orthopedic physical
therapy patients is unclear. Self-efficacy is theorized to mediate PROMIS physical
domain measures such as pain interference (PI), physical function (PF) and fatigue.
However, no current studies document the association between acceptable levels of
physical domain measures and self-efficacy. Although there are several self-efficacy
measures, managing symptoms is thought to be the most applicable to orthopedic patients.
The purpose of this analysis was to evaluate the associations between unacceptable
SEsx with physical health domain measures (PF, PI, and Fatigue).
Methods
PROMIS computer adaptive tests (PF, PI, Fatigue, SEsx) were administered at initial
evaluation(n=199) for spine (44.7%), lower extremity (35.7%), upper extremity (17.6%)
and other reasons (2.0 %) in physical therapy. Unacceptable T-scores were coded (0,1):
PF < 40, PI> 60, Fatigue>55, SE<45. Odds ratios (OR) and 95% confidence intervals
(CI) were calculated to examine the associations of unacceptable SEsx with other unacceptable
PROMIS measures. A logistic regression model including age, gender, unacceptable PROMIS
PF, SEsx, and Fatigue was evaluated for ability to independently predict unacceptable
PROMIS PI.
Results
Patient (age=42.5 (19.5), 60% female). The proportion of patients with unacceptable
symptoms were: PF 33.5%; PI 52.5%; Fatigue 40.7%, and SEsx 46.7%. The proportion of
patients with any unacceptable symptoms was 69.7%. A total of 14.6% reported all symptoms
at unacceptable levels. Unacceptable SEsx was significantly associated with: unacceptable
PI (OR = 8.3, CI 4.4 to 15.7), unacceptable PF (OR=7.5, 95%CI 3.8 to 14.9), and unacceptable
Fatigue (OR=3.5, CI 1.9 to 6.2). Logistic regression showed that unacceptable PF (OR
8.20, CI 2.23 to 30.86) and unacceptable SEsx (OR 4.5, CI 2.2 to 9.3) were independent
predictors of unacceptable PI.
Conclusion
The strong association of SEsx with PF and PI, and prevalence of unacceptable SEsx
measures suggests providers should develop methods to address SEsx in patients with
physical health measures indicating unacceptable function and symptoms. This finding
supports the theory that addressing patient confidence and beliefs (SEsx) may enhance
care directed at physical health.
126-P. Estimating power for clinical trials with PROMIS endpoints using Item Response
Theory
Jinxiang Hu, Yu Wang
1University of Kansas Medical Center
Correspondence: Jinxiang Hu (jhu2@kumc.edu)
Background
Patient reported outcomes (PRO) are important in patient-centered health outcomes
research, epidemiological studies, quality of life (QOL) studies, and clinical trials.
Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of standardized,
generic PRO questionnaires developed for clinical and research purpose. In clinical
trials, it is crucial to estimate power to avoid waste of resources while still able
to detect the treatment effect. However, for clinical trials with PRO as end points,
Classical Test Theory (CTT) using observed scores (e.g. total/ average scores) are
routinely used for power estimation. The purpose of this project is to provide guidance
for power and sample size estimate for clinical trials with PROMIS measures as endpoints
using IRT.
Methods
Motivated from PROMIS depression scales (4a, 6a, 8a), we conducted a simulation study
in order to estimate power differences between IRT- and CTT-based scoring for a two-
armed prospective randomized clinical trial (control vs active arm). We simulated
data using various sample size, allocation ratio, number of items, effect sizes, and
missing data. Three models were fit to each simulation: IRT with MLE, IRT with Bayesian
estimator, and CTT.
Results and conclusion
Our results showed missing data, effect size, and sample size are important indicators
of IRT power. Number of items is not significantly associated with power. For rare
diseases or early stage trials, it is important to use IRT framework for accurate
power estimation. IRT and CTT both provides good power with large sample size and
effect size. Future work can examine the IRT power for detecting change over time
and non-normal distribution of latent scores.
127-O. Validation of PROMIS measure of itch impact and intensity in pediatric patients
with Atopic Dermatitis
Kathryn L Jackson, Jin-Shei Lai, Amy Paller, Cynthia Nowinski, Stephanie Rangel, Divya
Ramachandran, Neha Puar, Vidhi Patel, Jonathan Silverberg, David Cella
All authors: Northwestern University, Feinberg School of Medicine, Chicago Illinois,
USA
Correspondence: Kathryn Jackson (kathryn.jackson1@northwestern.edu)
Background
Itch is the most common symptom of pediatric skin diseases, including atopic dermatitis
(AD), and greatly affects patient quality of life (QOL). Assessments of itch exist,
but lack comprehensiveness and psychometric validity. To fill this gap, we have developed
the new PROMIS Itch Questionnaire (PIQ-C). The PIQ-C was developed using mixed-methods
approaches and consists of 45 unidimensional items, calibrated using a graded response
model based on item responses from 600+ children with itch conditions. Here, we report
clinical validity of the PIQ-C using cross-sectional and longitudinal data.
Methods
Children aged 8-17 were recruited from Chicago-area dermatology clinics. Children
completed the PIQ-C and additional clinical assessments of disease severity/QOL (Itch
NRS, EASI, POEM, IGA, CDLQI) at baseline and 6-month follow-up. Severity measures
were categorized as mild/moderate/severe and change in severity from baseline to 6-
and 12-months were calculated and categorized as improved/ same/worse change. Convergent
validity was assessed by evaluating correlations of PIQ-C and an itch-related clinical
measure at baseline. Known groups validity was assessed using one-way Analysis of
Variance (ANOVA), modelling difference in PIQ-C score across severity group at baseline.
Responsiveness to change was assessed using mixed linear regression; differences in
change in PIC-Q score from baseline to six months was evaluated for differences between
clinical change group.
Results
181 patients aged 8-17 completed baseline PIQ-C; 59 completed the 6-month follow-
up. At baseline, PIQ-C was highly correlated with CDLQI (0.73), POEM (0.64), and moderately
correlated with Itch NRS (0.54). Significant increase in PIQ-C was found as severity
of AD increased across all clinical measures used to define severity (p<0.05 for all).
The PIQ-C was responsive to change across time; patients with improved clinical score
also had a significantly improved PIQ-C, and the change in PIQ-C differed across improved/same/worse
change groups in the expected direction (p<0.0001 for all).
Conclusion
The PIQ-C measure includes aspects of itch important to assessing overall symptoms
and impact. Correlations with known measures, ability to distinguish among severity
groups, and responsiveness across time suggest clinical validity. Next steps include
evaluating replicability of results in patients from other clinics and validation
in children with other itch conditions.
128-P. Investigating parameter stability in the presence of high slopes
Aaron J Kaat1, Stein Arne Rimehaug2
1Northwestern University, Chicago IL; 2University of Oslo, Norway
Correspondence: Aaron Kaat (aaron.kaat@northwestern.edu)
Objective
There is a growing recognition that large slopes in IRT models are not as desirable
of a trait as originally believed. Larger slopes suggest greater information and thus
higher reliability and a shorter computer adaptive testing experience; however, slopes
may be inflated when the IRT model fails to account for locally-dependent item subsets,
or when there is a preponderance of individuals at the floor or ceiling of the domain.
The objective of this study was to investigate the sampling distribution of the PROMIS®
Pain Interference 8-item short form (where slope inflation may be occurring) using
data from PROMIS 1 Wave 1, using both a standard normal latent distribution and when
estimating the latent distribution using Davidian curves.
Methods
We utilized general population data from PROMIS 1 Wave 1, for participants with item-level
data on at least 5 of the 8 items from the Pain Interference short form. In order
to investigate the effect of sample size on parameter stability, we conducted a bootstrap
resampling of sample size 500, 750, and 1259 (i.e., the total eligible number of participants).
The primary outcome was the slope estimates across replications. We utilized factorial
analysis of variance to investigate whether the slopes were significantly different
by latent density, sample size, and their interaction. Each item was analyzed separately.
Results
There was a main-effect for sample density in all 8 items, with higher slopes with
DC-IRT models. The difference by sample size was less consistent, with only 3 items
showing a difference in slopes by sample size. The interaction was nonsignificant
for all items.
Conclusions: Contrary to expectations, slopes were larger when the latent density
was estimated using Davidian Curves. Additionally, there was a higher frequency of
nonconvergence (even with 10,000 cycles) with DC-IRT models. The lack of significance
for sample size was encouraging, insofar as it suggests the parameters are robust
to sampling conditions. However, while the means were similar across sample sizes,
the range varied more widely with the smaller sizes (as would be expected). Future
research should evaluate whether a zero-inflated model would also provide consistent
slope estimates as here.
129-P. Comparing PROMIS® Global Health-10 and EQ-5D: sensitivity to clinical cut-off
scores for anxiety and depression.
Kabakibi B.1, Chaplin JE.2,3, Wicksell R.4
1Dept. of Public and Global Health, Gothenburg University, Gothenburg, Sweden; 2Dept.
of Paediatrics, Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg
University, Gothenburg, Sweden; 3Swedish Association of Local Authorities and Regions
(SALAR); 4Dept. of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Correspondence: John Chaplin (john.chaplin@gu.se)
Objective
To investigate the psychometric properties of the Swedish translation of the GH-10
questionnaire.
Methods
PROMIS GH-10, EQ5D, GAD7 and PHQ9 were electronically collected from consecutive attendees
of an emergency clinic from Sept 2018 to May 2019. Confirmatory factor analysis evaluated
the two-factor structure of the GH-10: physical (PCS) and mental (MCS). Goodness-of-fit
was defined as comparative fit index above .9 and standardized root mean square residual
(SRMR) above 0.08. Internal consistency and discriminant validity were assessed. Analyses
were repeated, stratified by cutoffs for clinical treatment, and sensitivity analysis
was conducted using receiver operating characteristic (ROC) curves.
Results
Of 164 patients (58% female) aged 18–88 (mean: 49 years), 58% were in full-time employment;
56% were overweight or obese. The two-factor solution indicated acceptable CFI: .935,
but the SRMR was .0567, thus below goodness-of-fit levels. Pain had the lowest factor
score on PCS. Internal consistency for the two sub-domains was good: Cronbach’s alpha
for PCS was 0.730, for MCS 0.862 and for the whole instrument 0.906. Hypothesized
relationships between GH10 subdomains and the other instruments were confirmed and
in line with previous published reports. Pearson’s correlations showed strong correlations
of the mental health subscale to the PHQ-9 (r=0.702) and the GAD-7 (r=0.704). Moreover,
the physical subscale of the GH-10 showed a good correlation with the EQ-5D index
(r=0.550) and with the EQ-5D VAS (r=0.565). The area under the curve (AUC) of the
MCS and PCS was higher than for EQ-5D against the GAD-7 PHQ-9 cutoffs.
Conclusions
Taking into account the sample size, the Swedish version of the GH10 has good psychometric
properties. The less well performing item concerning pain should be investigated further.
130-O. A Comparison of the measurement properties of the PROMIS-Fatigue (MS) 8b against
legacy fatigue questionnaires
Paul Kamudoni1, Jeffrey Johns2, Karon Cook5, Rana Salem4, Sam Salek 2, 3, Jana Raab1,
Rod Middleton6, Christian Henke1, Dagmar Amtmann4
1Global Evidence & Value Development – R&D, Merck Healthcare KgaA, Darmstadt; 2School
of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK; 3Institute
of Medicines Development, Cardiff, UK; 4Department of Rehabilitation Medicine, University
of Washington, Seattle, USA: 5Feral Scholars, Broaddus, Texas, USA; 6UK MS Register,
Swansea Medical School, Swansea, UK
Correspondence: Paul Kamudoni (paul.kamudoni@merckgroup.com)
Objectives
Amidst the growing number of patient-reported outcome (PRO) measures of fatigue being
used in MS clinical trials and clinics, evidence-based consensus on generalizable
and the most appropriate measures across different settings would be beneficial for
clinical research as well as patient care.
To compare the validity and responsiveness of the PROMIS SF v1.0 - Fatigue (MS) 8b
with the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS),
across US and UK populations
Methods
Two observational studies were performed in MS populations, as part of a PRO measure
development project, including a cross-sectional study in two tertiary MS centers
in the US (n=296) (US sample) and a 96-week longitudinal study in the UK MS Register
cohort (still ongoing) (n = 384) (UK sample). Analyses included examination of: 1)
relative validity based on ability to discriminate across patient subgroups according
to fatigue or functional status at baseline [i.e. ANOVA-F PRO
X
÷ ANOVA-F PROMIS-F(MS)8b]; and 2) relative responsiveness, based on baseline-to-week-52
score change (Effect size) across fatigue or functional status response groups (UK
sample only).
Results
The mean age was 44.5±11.2 / 50.7±9.4; and 74 %/ 75.9% were female (US /UK Samples).
The mean PROMIS-F(MS)8b T-score at baseline was 57.4±10.5 / 59.9±9.4 (US sample /
UK sample). Compared with the PROMIS-F (MS)8b, relative validity (anchor: GHS fatigue
global question) was 86% for MFIS symptom score, 87% for MFIS total score, and 42%
for the FSS. Relative to the FSS, PROMIS-F(MS) 8b scores were more sensitive to worsening
(ES = -0.44 vs. -0.18) as well improvement (ES = 0.5 vs. 0.2) in fatigue (>=1- point
increase/decrease in GHS fatigue global question) over 52 weeks of follow-up. A similar
pattern of score change was observed based on other anchors.
Conclusion
The PROMIS-F(MS)8b scores showed a higher precision when differentiating levels of
fatigue than the FSS or the MFIS physical or total scores, and higher responsiveness
to fatigue changes than the FSS. These differences have practical implications on
the application of these questionnaires in both clinical practice and research settings
e.g. in sample size estimation in clinical trials.
131-P. Validation of the PROMIS® Pediatric Item Banks Anxiety and Depressive Symptoms
in a general Dutch population
Leonie H. Klaufus1,2, Michiel A.J. Luijten3,4, Eva Verlinden1, Marcel F. van der Wal1,
Caroline B. Terwee4, Pim Cuijpers5, Mai J.M. Chinapaw2, Lotte Haverman3
1Public Health Service Amsterdam, Department of Epidemiology, Health Promotion, and
Health Care Innovation, Amsterdam, Netherlands; 2Amsterdam UMC, Vrije Universiteit
Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research
institute, Amsterdam, Netherlands; 3Amsterdam UMC, Emma Children’s Hospital, Psychosocial
Department, Amsterdam, Netherlands; 4Amsterdam UMC, Vrije Universiteit Amsterdam,
Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute,
Amsterdam, Netherlands; 5Vrije Universiteit Amsterdam, Department of Clinical, Neuro
and Developmental Psychology, Amsterdam Public Health research institute, Amsterdam,
Netherlands
Correspondence: Leonie H. Klaufus (LKlaufus@ggd.amsterdam.nl)
Objective
This study aims to validate the Dutch-Flemish PROMIS pediatric item banks v2.0 Anxiety
and Depressive Symptoms in a general Dutch population.
Methods
Participants (N = 2,893, aged 8 - 18), recruited by two certified internet panel agencies,
completed the PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms online.
Both item banks were assessed on unidimensionality, local dependence, monotonicity,
Graded Response Model (GRM) item fit, and differential item functioning (DIF) across
gender, age groups, region, ethnicity, and language. The PROMIS pediatric Anxiety
and Depressive Symptoms short forms 8a and simulated computerized adaptive testings
(CATs) were assessed on reliability and construct validity compared to the Revised
Child Anxiety and Depression Scale short version (RCADS-22) subscales.
Results
The PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms showed sufficient
unidimensionality (Omega H = 0.83, 0.95; ECV = 0.79, 0.93, respectively), local independence
(residual correlations < 0.2), and monotonicity (H = 0.61, 0.69, respectively). Both
item banks showed sufficient GRM item fit (S-X2
p-value < 0.001), except for the Depressive Symptoms items 2697R1r “I wanted to be
by myself“, 7010 “I felt sad for no reason“, and 9001r “I felt too sad to eat”. No
DIF was found for gender, age groups, region, ethnicity, and language, except for
the Depressive Symptoms items 2697R1r “I wanted to be by myself” and 488R1r “I could
not stop feeling sad” that showed uniform DIF for language (McFadden pseudo R
2
change > 2%). Based on U.S. parameters, the PROMIS pediatric Anxiety and Depressive
Symptoms short forms 8a showed a reliability of > 0.90 in 2% and 34%, and the CATs
in 26% and 41% of the participants, respectively. Both short forms and CATs revealed
high positive correlations (r > 0.70) with the corresponding RCADS-22 subscales and
slightly lower correlations with the non-corresponding RCADS-22 subscales (r ≤ 0.70).
Conclusions
The Dutch-Flemish PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms
show sufficient psychometric properties, except for four Depressive Symptoms items
that show DIF for language or poor GRM item fit; the short forms 8a and CATs seem
valid, but reliable for a small percentage of children.
132-P. Evaluation of a patient-reported frailty tool in Systemic Lupus Erythematosus
Sarah B. Lieber1, Stephen Paget1,2, Jessica R. Berman,1,2 Medha Barbhaiya,1,2, Lisa
R. Sammaritano,1,2, Kyriakos Kirou,1,2, John A. Carrino,1,2, Musarrat Nahid,2, Mangala
Rajan,2, Dina Sheira1, Lisa A. Mandl1,2
1Hospital for Special Surgery, New York, NY; 2Weill Cornell Medicine, New York, NY
Correspondence: Sarah B. Lieber, MD, MS (liebers@hss.edu)
Objective
Frailty is associated with disability in systemic lupus erythematosus (SLE). To our
knowledge, no phenotypic frailty tool including objective/subjective domains has been
compared to a validated point-of-care frailty measure in SLE. We evaluated the point-of-care
self-reported FRAIL scale (FS) versus the standard Fried phenotype (FP) by comparing
the prevalence of frailty as measured by both tools in a cohort of women with SLE.
We also evaluated the association of each frailty measure with several patient-reported
outcomes (PROs), comparing associations in frail versus non-frail women.
Methods
Adult women <70 years old with validated SLE and mild/moderate disease enrolled from
one center. Measures included: frailty (FP/FS); disease activity/damage; and PROs
(PRO Measurement Information System (PROMIS) computerized adaptive tests (CATs) and
Valued Life Activities (VLA) disability). Differences between frail and non-frail
participants were evaluated using Fisher’s exact or Wilcoxon rank sum tests and the
association of frailty with disability using logistic regression. Correlation between
the FP and the FS was determined using Spearman’s correlation.
Results
72 women enrolled; 67 (93%) completed the FS. 17% (FP) and 27% (FS) were frail. Frail
women according to either definition had greater disease damage (FP: p=0.002; FS:
p=0.0006) and worse PROMIS CATs, including mobility, physical function, pain behavior
and interference, and fatigue (FP and FS: all p<0.01). Compared with non-frail women,
frail women classified by the FP had greater comorbidity (p=0.02); when classified
by the FS, frail women were older (p=0.04) with worse PROMIS CAT depression (p=0.02).
Frailty according to either definition was associated with VLA disability after adjustment
for age, comorbidity, and disease activity (FP: p=0.02; FS: p=0.0003), but this relationship
was attenuated for the FP after adjustment for disease damage (p=0.08). There was
moderate correlation between the FS and the FP (r=0.48; p<0.0001).
Conclusions
Prevalence of patient-reported frailty was high in this cohort of women with SLE.
Frailty, measured with either metric, was associated with worse PROs, providing face
validity for both definitions. The FS was associated with disability even after adjustment
for multiple confounders. These data suggest that the FS may be an informative point-of-care
tool to identify frail women with SLE.
133-O. Patient-Reported Outcomes Measurement Information System (PROMIS) - Translation
and cultural adaptation of Chinese version of severity of substance use
Yan Rong, Yun Ting, Shang Meimei, Xu Juan, Huang Ame
All authors: Shandong Cancer Hospital and Institute, Shandong First Medical University
and Shandong Academy of Medical Sciences)
Correspondence: Yun Ting (yunting.love@qq.com)
Introduction
Patient-reported outcomes and listening to the true feelings of the patient are the
hot spot in cancer research both in China and abroad recently. Given the increase
in misuse and abuse of prescription opioids, clinicians clearly benefit from a standardized
tool to screen screening opioid overuse. In 2009, the International Society for Pharmacoeconomics
and Outcome Research (ISPOR), FDA, the Health-related quality of Life working Group
and the International Association for quality of Life Research (ISQOL) jointly put
forward that incorporating patient self-reporting data into the evaluation system
of clinical decision-making, Combined with the patient self-reporting measurement
system, it can help clinicians to better detect and screen abnormal drug use behavior,
and lay the foundation for early intervention.
Objectives
The present study developed a Chinese version of the Severity of Substance Use, and
incorporated into the Patient-Reported Outcomes Measurement Information System to
promote domestic opioid abuse screening, improve drug evaluation and promote clinical
nursing and drug management.
Methods
After applying for authorization from the American PROMIS data management center,
the translation method of FACIT (Functional Assessment of Chronic Illness Therapy)
was adopted. After simultaneous forward translations, reconciliation, back-translation,
expert review and proofreading, the first translation draft was formed and submitted
to the PNC-China center for quality review. On the basis of the review, cognitive
interviews were conducted among 5 cancer patients (at least 5 patients in each item)
who were eligible for inclusion, and the interviewees pointed out the items and phrases
that were difficult to understand, as well as the possible difficulties in the answer
process. The interviews with each patient were recorded and recorded with their consent.
The head of the translation team will sort out the patient's feedback, and the cultural
mediator will provide the appropriate translation plan with reference to the patient's
opinion. After cultural debugging, the final Chinese version of the drug use severity
scale was formed.
Results
A Chinese version of the severity scale of drug use was formed.
Conclusion
We provide a culturally adjusted Chinese version of screening tool for drug abuse
in China, and the translation has gone through a standardized process and cultural
debugging, which can be used to screen drug abuse in China.
134-P. A PROMISing prospect of measuring pediatric general health: A comparison of
the PROMIS® pediatric Global Health scale (PGH-7) and the Pediatric Quality of Life
Inventory (PedsQLTM).
Michiel A. J. Luijten1,2, Lotte Haverman1, Raphaële R.L. van Litsenburg3,4, Leo D.
Roorda5, Martha A. Grootenhuis3, Caroline B. Terwee2
1 Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam, Psychosocial Department,
Amsterdam, the Netherlands; 2 Amsterdam UMC, Vrije Universiteit, Epidemiology and
Biostatistics, Amsterdam, the Netherlands; 3 Princess Máxima Center for Pediatric
Oncology, Utrecht, the Netherlands; 4 Emma’s Children’s Hospital, Amsterdam UMC, Vrije
Universiteit Amsterdam, 5Pediatric Oncology, Cancer Center Amsterdam, Amsterdam, the
Netherlands
Correspondence: Michiel A.J. Luijten (m.a.luijten@amc.nl)
Objective
On February 18th 2020 the International Consortium for Health Outcomes Measurement
(ICHOM) announced the release of the Standard Set for overall pediatric health. This
outcome set contains the Patient-Reported Outcomes Measurement Information System
(PROMIS) Pediatric Scale v1.0 Global Health (PGH-7+2) for measuring overall physical,
mental and social health. Our aim was to assess the psychometric properties of the
PGH-7 in the Dutch population and to compare the performance of the PGH-7 with the
Pediatric Quality of Life Inventory (PedsQLTM).
Methods
Children aged 8-18 years (n=2654), representative of the Dutch population on key demographics
were asked to complete the PGH-7 (nitems=7) and the PedsQL (nitems=23). To assess
structural validity of the PGH-7 a graded response model (GRM) was fitted to the data
after assessing the following assumptions: Unidimensionality through CFA (CFI>.95,
TLI>.95, RMSEA<.10), local independence by residual correlations (r<.20) and monotonicity
by Mokken analysis (H>.50, H
i
>.30). Item fit of the GRM model was inspected with S-X2, where p<.001 indicates misfit.
Additionally, convergent validity of the PGH-7 T-score with the PedsQL total score
was assessed. A moderately strong correlation (>.50) was expected, as both instruments
measure physical, mental and social domains. Percentage of participants reliably measured
was assessed using the standard error of measurement (SEM) <0.32 as a criterion (which
equals a reliability of 0.90). Relative efficiency was calculated (1- SEM2)/nitems)
to compare how well both instruments perform relative to the amount of items administered.
Results
In total 1082 (response rate = 40.8%) children completed both questionnaires. All
GRM assumptions were met. PGH-7 displayed good structural (no misfit) and convergent
(r=.65) validity. Both questionnaires measured reliably (nPGH-7=74.5%, nPedsQL=76.6%)
at the mean and 2SD in clinically relevant direction. The relative efficiency of the
PGH-7 was 2.6 in comparison to the PedsQL, indicating that, on average, the items
in the PGH-7 are 2.6 times more informative than PedsQL items.
Conclusions
The PGH-7 displays sufficient reliability and validity in the general Dutch pediatric
population. The scale measures more efficiently than the most commonly used legacy
instrument (PedsQL).
135-P. How the COVID-19 pandemic impacts the psychosocial well-being of children and
adolescents in the Netherlands
Michiel A.J. Luijten1,2, Maud M. van Muilekom1, Lorynn Teela1, Hedy A. van Oers1,
Kim J. Oostrom1, Lotte Haverman1
1Amsterdam UMC, University of Amsterdam, Department of Child and Adolescent Psychiatry,
Pediatric Psychology and Psychosocial Care, Emma Children’s Hospital, Amsterdam Public
Health, Meibergdreef 11, Amsterdam, the Netherlands;2Amsterdam UMC, Vrije Universiteit
Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health,
De Boelelaan 1117, Amsterdam, the Netherlands
Correspondence: Michiel A.J. Luijten, MSc; (m.a.luijten@amc.nl)
Objective
Recent measures of implementing social isolation and physical distancing as governmental
reactions to the COVID-19 outbreak profoundly impact daily life, including that of
children and adolescents. Suddenly children and adolescents were not allowed to go
to school or participate in sports or other socializing activities anymore. It is
therefore relevant to investigate the impact of these measures on psychosocial outcomes
in children and adolescents in the general population. In this study we surveyed how
the COVID-19 outbreak impacts the psychosocial functioning in a sample of Dutch children
and adolescents during the first months of lockdown in one of the largest public health
crisis of our time.
Methods
In April 2020, children and adolescents aged 8-18 years, representative of the Dutch
population on key demographics, were asked to complete the following Patient-Reported
Outcomes Measurement Information System (PROMIS®) computerized adaptive tests (CATs);
anger, anxiety, depressive symptoms, peer relationships, sleep-related impairment
and the global health scale, online using the KLIK PROM portal (www.hetklikt.nu).
In addition, parents were asked to complete sociodemographic questions about themselves
(age, ethnicity, education level) and their child (age, gender, education level and
presence of chronic conditions). Finally, both children and parents answered COVID-19
specific questions such as consequences for employment, school and the atmosphere
at home. Using independent sample T-tests, PROMIS COVID-19 T-scores were compared
to normative data that were collected in the general population pre-COVID (2018; n=1098).
Additionally, the same data was gathered simultaneously in a sample of chronically
ill children/adolescents and a sample of pediatric psychiatric patients.
Results and Conclusion
In total, 902/90/265 children and parents completed all questionnaires for respectively
the general population/chronically ill/psychiatric samples. Preliminary results indicate
that during the COVID quarantine, children scored significantly (p < 0.001) lower
on all domains measured by the PROMIS CATs when compared to pre-quarantine normative
data. Children and families experience the quarantine differently, as some children
indicate that the atmosphere at home has improved, while others indicate a decline
in atmosphere. However, further analyses are required to compare groups on background
characteristics and to determine possible relevant covariates that may impact psychosocial
functioning. These results will be shown at the conference
136-O. Integrating PROMIS CAT collection into Epic: tips for success
Eric C. Makhni
Henry Ford Health System, Detroit, MI USA
Correspondence: Eric C. Makhni (ericmakhnimd@gmail.com)
Objective
There are many significant challenges in implementing PROMIS CAT collection for effective
and efficient population health applications. One of the biggest challenges is in
effectively integrating this platform with daily clinical operations through the electronic
medical record. While third-party platforms offer numerous advantages with regards
to customization that may be appealing to medical providers, they can be costly and
do not fully integrate into the electronic medical record. The purpose of this presentation
is to highlight technical and practical key steps to effectively developing a PROMIS
CAT platform within a widely used electronic medical record (Epic, Verona, WI, USA).
Methods
A PROM platform was designed with the following objectives: 1) electronic questionnaire
assignment fully integrated through the native EHR on a 2) population basis through
the orthopedic department, such that all ambulatory patients (and not just surgical
patients) received questionnaires. The primary outcome was questionnaire completion
rate during an initial pilot implementation. Secondary outcomes included completion
rates by questionnaire type, patient age (<45 years, 45-64 years, and 65+ years),
and visit type (new or follow-up patient), along with psychometric data of included
questionnaires.
Results
An automated PROM platform was created through the native workflow and EHR, without
the hiring of any additional personnel, utilizing National Institutes of Health (NIH)
Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive
test (CAT) questionnaires. Among the first 1,930 ambulatory encounters and 8,383 questionnaires
administered, there was an overall completion rate of 86%, with no questionnaire type
completed less than 80% of the time. Questionnaire completion rate among the two youngest
age groups (<45 and 45-64 years) was approximately 87%, compared to 83% among patients
65 and older. New patient questionnaire completion rate was 91%, compared to 81% for
follow-up patients. There were favorable floor and ceiling effects for all PROMIS
questionnaires, with the exception of PROMIS Depression, which had a high floor effect.
Conclusions
The results of this pilot study demonstrate feasibility of administering PROMs on
a population basis through an EHR. The questionnaire completion rate of (86%) exceeded
the target for this pilot phase (60%) and for steady-state implementation (80%). This
methodology can serve as a model for effective PROM collection.
137-P. Design, development, and implementation of an integrated and automated patient
reported outcome measure platform through a native electronic health record: Results
from the first 2,000 ambulatory encounters and 8,400 questionnaires administered
Eric C. Makhni, Jason Davis, Michael Charters, Stephanie Muh, Kelechi Okoroha, Charles
S. Day, Theodore Parsons
All authors: Henry Ford Health System, Detroit, MI, USA
Corresponding Author: Eric C. Makhni (ericmakhnimd@gmail.com)
Background
Patient reported outcome measures (PROMs) represent the gold standard for reporting
patient-centric health state measures in orthopedics. However, routine collection
of PROMs in the busy ambulatory setting is challenging due to a number of constraints.
The purpose of this study was to design and implement a successful PROM platform through
a native electronic health record (EHR).
Methods
A PROM platform was designed with the following objectives: 1) electronic questionnaire
assignment fully integrated through the native EHR on a 2) population basis through
the orthopedic department, such that all ambulatory patients (and not just surgical
patients) received questionnaires. The primary outcome was questionnaire completion
rate during an initial pilot implementation. Secondary outcomes included completion
rates by questionnaire type, patient age (<45 years, 45-64 years, and 65+ years),
and visit type (new or follow-up patient), along with psychometric data of included
questionnaires.
Results
An automated PROM platform was created through the native workflow and EHR, without
the hiring of any additional personnel, utilizing National Institutes of Health (NIH)
Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive
test (CAT) questionnaires. Among the first 1,930 ambulatory encounters and 8,383
questionnaires administered, there was an overall completion rate of 86%, with no
questionnaire type completed less than 80% of the time. Questionnaire completion rate
among the two youngest age groups (<45 and 45-64 years) was approximately 87%, compared
to 83% among patients 65 and older. New patient questionnaire completion rate was
91%, compared to 81% for follow-up patients. There were favorable floor and ceiling
effects for all PROMIS questionnaires, with the exception of PROMIS Depression, which
had a high floor effect.
Conclusions
The results of this pilot study demonstrate feasibility of administering PROMs on
a population basis using a native electronic health record. The questionnaire completion
rate of (86%) exceeded the target for this pilot phase (60%) and for steady-state
implementation (80%). This methodology can serve as a model for effective PROM collection.
138-P. Role of pre-operative PROMIS scores in predicting post-operative outcomes and
likelihood of achieving MCID following arthroscopic rotator cuff repair
Joseph S. Tramer, Sreten Franovic, Noah Kuhlmann, Colin Schlosser, Alex Pietroski,
Vasilios Moutzouros, Stephanie J Muh, Eric C. Makhni
All authors: Henry Ford Health System, Detroit, MI, USA
Corresponding Author: Eric C. Makhni (ericmakhnimd@gmail.com)
Background
The Patient-Reported Outcomes Measurement Information System (PROMIS) has emerged
as a valid and efficient means of collecting outcomes in patients with rotator cuff
tears. The purpose of this study was to examine the role of pre-operative PROMIS computer
adaptive test (CAT) scores in predicting post-operative PROMIS CAT scores, as well
as likelihood of achieving minimal clinically important difference (MCID) following
rotator cuff repair. We hypothesize that pre-operative PROMIS CAT scores will directly
impact both post- operative PROMIS CAT scores and likelihood of achieving MCID.
Methods
Patients undergoing arthroscopic rotator cuff repair by one of three fellowship-trained
surgeons were identified over a 12-month period. Only patients that completed both
pre- operative and post-operative PROMIS CAT assessments were included in this cohort.
PROMIS CAT forms for upper extremity physical function (PROMIS-UE), pain interference
(PROMIS- PI), and depression (PROMIS-D) were utilized. MCID was calculated according
to both distribution-based (db) and anchor-based (ab) methodology, and receiver operating
characteristics (ROC) were utilized to determine if pre-operative scores were predictive
of post- operative outcomes, with 95% specificity.
Results
One hundred and seventeen rotator cuff repair patients were included for statistical
analysis with surveys completed an average of 29±36 days before and 243±117 days after
surgery. PROMIS-UE improved from 30.3 to 38.7 (p<0.05), PROMIS-PI improved from 62.7
to 53.3 (p<0.05), and PROMIS-D improved from 47.4 to 44.3. The average change from
pre- operative scores to post operative scores in PROMIS-UE and PROMIS-PI exceeded
their dbMCIDs of +3.3 and -2.8, respectively. Similarly, PROMIS-UE, PROMIS-PI, and
PROMIS-D exceeded their abMCIDs of 27 +3.1, -4.7, and -3.1, respectively. The percent
of patients who met dbMCID for PROMIS-UE, PROMIS-PI and PROMIS-D was 67.8%, 75.4%,
and 37.5%, respectively. After introduction of 95% specificity cutoffs, percentage
of patients achieving dbMCID for PROMIS-UE, PROMIS PI, and PROMIS-D increased to 86.7%,
88.9%, and 50.0%, respectively. Similarly, the cohort’s probability of achieving abMCID
for PROMIS-UE, PROMIS-PI, and PROMIS-D was 66.7%, 64.7%, and 48.2%, respectively.
When prognostic cutoffs were introduced, probability of achieving abMCID for PROMIS-UE,
PROMIS-PI, and PROMIS-D all increased to 86.7%, 83.3%, and 66.7%, respectively.
Conclusion
Arthroscopic rotator cuff repair is an effective surgery for symptomatic patients
with rotator cuff tears, resulting in improvements of PROMIS-UE, PROMIS-PI, and PROMIS-D.
Pre-operative PROMIS CAT domain scores can be utilized to predict likelihood of achieving
or failing to achieve significant improvement across all three health domains.
139-P. Presence of preoperative clinical depression does not hinder recovery after
anterior cruciate ligament reconstruction
Eric Guo, Austin Cross, Luke Hessburg, Dylan Koolmes, David Bernstein, Vasilios Moutzouros,
Eric C. Makhni
All authors: Henry Ford Health System, Detroit, MI, USA
Correspondence: Eric C. Makhni (ericmakhnimd@gmail.com)
Background
Current literature suggests a link between psychosocial factors and poor surgical
outcomes in patients with musculoskeletal complaints. However, there is a limited
body of literature examining the effect of depression on outcomes after anterior cruciate
ligament reconstruction (ACLR). The goal of this study is to determine the prevalence
of depression in ACLR patients and evaluate its effect on patient-reported outcomes
postoperatively.
Methods
In this single center retrospective cohort study, 121 pediatric and adult patients
who underwent ACLR were included. PROMIS Physical Function (PF), Pain Interference
(PI) and Depression (D) scores collected preoperatively and six months postoperatively
were reviewed. A PROMIS D ≥ 55 served as a validated threshold for clinical depression.
Patients were separated into clinical depression (CD) and no clinical depression (NCD)
groups based on preoperative PROMIS D score.
Results
121 patients undergoing ACLR were included in this study. 24 (20%) patients met criteria
for clinical depression. Preoperatively, the CD group reported lower mean PROMIS PF
(34.6 vs. 40.2, [p < 0.01], higher PROMIS PI (65.1 vs. 59.1, [p< 0.01]) than those
in the NCD group. Postoperatively, the mean PROMIS PF scores for the CD and NCD group
were 48.7 and 51.0, respectively (p = 0.2). Mean postoperative PROMIS PI scores for
the CD and NCD cohorts were 52.3 and 48.1, respectively (p = 0.04). After ACLR, there
was substantial improvement in PROMIS PF, PROMIS PI in both the CD (+14.1 and -12.8,
respectively) and NCD cohorts (+10.8 and -10.4, respectively).
Conclusion
Prevalence of preoperative depression in ACLR patients could be as high as 20%. Despite
high prevalence of depression preoperatively, there is a significant increase – which
exceeds currently accepted MCID values - in PROMIS PF scores after ACLR regardless
of presence of preoperative clinical depression. This data suggest that high scores
on PROMIS-D pre-operatively do not significantly hinder a patient’s recovery after
ACLR.
140-P. Establishing and comparing reference pre-operative PROMIS scores in patients
undergoing shoulder surgery
Eric W Guo, Kareeem Elhage, Austin Cross, Luke Hessberg, Caleb Gulledge, Eric C. Makhni
All authors: Henry Ford Health System, Detroit, MI, USA
Correspondence: Eric C. Makhni (ericmakhnimd@gmail.com)
Background
The Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly
popular amongst orthopaedic surgeons treating shoulder pathology. Despite this, there
have been few studies that describe and compare preoperative reference scores for
specific shoulder surgeries. The primary purpose of this study was to establish and
compare baseline preoperative PROMIS scores for three common types of shoulder surgery:
rotator cuff repair (RCR), total shoulder arthroplasty (TSA) and labrum repair (LR).
The authors hypothesized that PROMIS scores would be sensitive enough such that each
surgical group would have a different score compared to the other groups.
Methods
In this retrospective cohort study, adult and pediatric patients who underwent surgery
for either RCR, TSA, or LR were included. PROMIS-Upper extremity (UE), Pain Interference
(PI), and Depression (D) scores that were collected at each patient’s preoperative
visit were reviewed. Continuous and categorical variables were compared between operative
groups using analysis of variance (ANOVA) and chi-square or Fisher’s exact tests,
respectively. Multivariable general linear models were used to identify significant
independent predictors of PROMIS scores when controlling for age, sex, and BMI.
Results
413 patients were included in the study. 272 were in the RCR group, 84 in the TSA
group, and 57 in the LR group. The average LR PROMIS-UE was 39.8 compared to the RCR
group (29.9, p < 0.001) and the TSA group (29.6, p < 0.001). There was no difference
between the mean RCR and TSA PROMIS-UE (p = 0.93). The average LR PROMIS-PI was 56.6
compared to the RCR group (62.8, p < 0.001) and the TSA group (63.9, p < 0.001). There
was no difference between RCR and TSA PROMIS-PI (p = 0.09). The average LR PROMIS-D
was 43.5 compared to the RCR group (47.7, p = 0.004) and the TSA group (50.3, p <
0.001). The TSA group also had higher mean PROMIS-D than the RCR group (p = 0.03).
For PROMIS-UE and PI, age, BMI, and gender were not found to be significant independent
predictors (p = 0.98, 0.88; p = 0.31, 0.48, respectively).
Conclusion
Patients undergoing shoulder labrum repair had higher preoperative function scores
and lower pain interference and depression scores than those undergoing TSA and RCR.
These baseline PROMIS scores should be taken into consideration when tracking a patient’s
outcomes after surgery, as a certain score could mean drastically different functional
and pain outcomes depending on the underlying pathology.
141-P. Withdrawn
142-O. Clinically relevant thresholds and meaningful differences for PROMIS Physical
Function and I-RODS: patient survey in CIDP
Rajiv Mallick1, Noemi Hahn2, Ingemar Merkies3,4
1CSL Behring, King of Prussia, PA, USA; 2Bryter, New York, NY, USA; 3Department of
Neurology, Maastricht University Medical Center, Maastricht, the Netherlands; 4Department
of Neurology, St Elisabeth Hospital, Willemstad, Curaçao
Correspondence: Rajiv Mallick (Rajiv.Mallick@cslbehring.com)
Objective
To identify clinically relevant thresholds for PROMIS Physical Function (PF) T- scores
and Inflammatory Rasch-built Overall Disability Scale (I-RODS) scores to distinguish
disability levels, based on a novel approach in patients with chronic inflammatory
demyelinating polyneuropathy (CIDP).
Methods
Online global GBS/CIDP Foundation survey data from 426 adults with self- reported
CIDP were used to classify two patient-reported outcomes (PROs; PROMIS PF T- scores
from the Short Form-4 and I-RODS Rasch-transformed centile scores for social activity/participation)
in three disability measures: work impairment, residential changes and need for assistive
devices. Chi-square automatic interaction detection (CHAID) was used to identify range
of clinically relevant thresholds, meaningful group differences and associated effect
sizes (differences/SD) in scores based on most substantial shifts in proportion of
patients at highest levels for each disability measure.
Results
Mean (SD) PROMIS PF T-score was 36.5 (7.9) (tertiles: 23–33, 34–39, 40–57), and mean
I-RODS centile score was 56.2 (16.9). PROMIS PF T-scores of 34–40 (median: 36) and
in the highest tertile (41–57; median: 44) were associated with only 5% and 0–2% of
patients needing a wheelchair (highest of three levels of need for assistive devices),
respectively. By contrast, among those in the highest PROMIS PF T-score tertile, 29%
had retired or claimed disability pay (highest level of work impairment) and 15% moved
to a single-story home, with family or assisted-living facility (highest level of
residential changes). Findings were similar for I-RODS. A group median difference
of 6 (23 to 29; effect size: 0.76) in PROMIS PF T-score was associated with greatest
shift (39%) in wheelchair dependency from 66% to 27%. By contrast, a group median
difference of 11 (23 to 34; effect size: 1.39) was needed to shift highest level of
work impairment from 84% to 56%, and a group median difference of 10 (34 to 44; effect
size: 1.26) was needed to shift highest level of residential changes from 31% to 15%.
Conclusions
Clinically relevant thresholds (range: 36–44) and meaningful differences (range: 6–11;
effect size: 0.76–1.39) of PROMIS PF T-scores varied with the underlying cross-sectional
anchor (specific disability measure) and physical function trait levels in CIDP patients.
Interpretation of meaningfulness of between-group PROMIS PF T-scores may be better
informed by realistic assessment of limits in terms of change on an underlying anchor
in the context of this high-burden disease.
143-P. Development and validation of the Pediatric PROMIS Pain Quality Scale
A. Mara1,2, Adam C. Carle2,3, Susmita Kashikar- Zuck1,2, Dennis Revicki4, Kenneth
Goldschneider2,5, David D. Sherry6, Carlton Dampier7, Jennifer Farrell Miller8, Kimberly
Barnett9, Jenna Tress6, C. Jeffrey Jacobson10,11, Natoshia R. Cunningham12, Esi Morgan2,13
1Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical
Center; 2Department of Pediatrics, University of Cincinnati College of Medicine; 3James
M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical
Center; 4Center for Health Outcomes Research, Evidera; 5Department of Anesthesiology,
Cincinnati Children’s Hospital Medical Center; 6Division of Rheumatology, Children’s
Hospital of Philadelphia; 7Department of Pediatrics, Emory University School of Medicine
and AFLAC Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta; 8Counseling
and Psychological Services, University of Central Florida; 9Brigham Young University,
Department of Psychology; 10Department of Anthropology, University of Cincinnati College
of Arts and Sciences; 11Family and Community Medicine, University of Cincinnati College
of Medicine;12Department of Family Medicine, Michigan State University; 13Division
of Rheumatology, Cincinnati Children’s Hospital Medical Center
Correspondence: Constance A. Mara (Constance.Mara@cchmc.org)
Objective
The primary objective of this study is to evaluate the dimensionality and validity
of the Pediatric PROMIS Pain Quality Scale.
Methods
The data used in this study included pediatric patients with chronic widespread musculoskeletal
pain (fibromyalgia), juvenile idiopathic arthritis, or sickle cell disease ages 8
to 18 treated at three academic medical centers in Ohio, Pennsylvania, and Georgia
for a total sample size of N = 447. Initial pools of the pediatric PROMIS pain-related
items were developed based on literature reviews, clinician interviews, and qualitative
research with patients with chronic pain conditions. Our prior research has focused
on the development of three constructs related to pain (pain interference, pain intensity,
and pain behavior). The current project focused on the development of a pain quality
item bank. A total of 59 candidate items were developed. The pediatric pain quality
item bank assesses the specific physical sensations and affective components associated
with pain. Because pain can be felt and described in so many ways, this category of
pain contains a variety of attributes, such as perceived temperature (e.g., cold),
sensations (e.g., throbbing), and perceived affective qualities of pain (e.g., uncomfortable).
We conducted confirmatory factor analysis (CFA) to assess dimensionality of the 59
items for pain quality. Of these, 23 items measured "affective" aspects of pain quality
and were in the format of “In the past 7 days, did your pain ever feel “(e.g., miserable,
unpleasant), with dichotomous response options (yes/no). The remaining items assessed
the "sensory" aspect of pain quality and were in the format “In the past 7 days, did
your pain ever feel "(e.g., sharp, achy), with a 5-point response option scale ("not
at all" to "very much"). Additionally, we developed both sensory and affective pain
quality 8-item short forms based on feedback from pain management clinicians.
Results
The 59-item unidimensional model fit the data well: comparative fix index (CFI) =.93,
Tucker-Lewis index (TLI) =.93, and root mean square error of approximation (RMSEA)
= 0.056. The IRT discrimination parameters ranged from 1.05 to 3.81. Three items were
excluded due to discrimination parameters less than 1.0. The category threshold parameters
for the remaining 56 items ranged from -1.02 to 3.66.
Conclusions
The 56-item pediatric PROMIS pain quality item bank includes both "sensory" and "affective"
pain quality 8-item short forms that can be used in research and clinical practice.
This information may be useful for understanding the condition-specific experiences
of pain as well as outcome evaluations.
144-O. Agreement between child and caregiver reports across five PROMIS scales in
a pediatric burn population
Kara McMullen1, Alyssa Bamer1, Lewis Kazis2, Cami Rencken3, Steven Wolf4, Barclay
T Stewart5, Dagmar Amtmann1
1University of Washington Department of Rehabilitation Medicine; 2Boston University
School of Public Health; 3Brown University School of Public Health; 4University of
Texas Medical Branch; 5University of Washington Department of Surgery, Harborview
Injury Prevention and Research Center
Correspondence: Kara McMullen (mcmulk@uw.edu)
Objective
To examine the agreement between self- and proxy-report on pediatric PROMIS scales
of physical function, depression, peer relationships, pain interference, and anger
in children and youth who have sustained a burn injury.
Methods
Data were collected from children ages 8-17 years who have sustained a moderate to
severe burn injury and their caregivers during Burn Model Systems (BMS) National Longitudinal
data collection. Self- and proxy-report scales were completed at the same timepoint
between 6 months and 15 years after burn injury at regular intervals. The PROMIS-25
and Anger Short Form v1.0 were completed by pediatric burn participants. Caregivers
completed either custom (depression, pain) or standard (Physical Function 8a, Peer
7a, Anger 5a) PROMIS proxy short forms. Self- and proxy-report were compared using
paired t-tests, effect size (d), Cohen’s weighted Kappa, and intraclass correlation
coefficients (ICC(2,1) individual measures). Concordance by levels of severity (≥10
points worse than mean) for each health domain was also examined.
Results
A total of 274 child-caregiver pairs completed the PROMIS measures. Mean child age
was 13.0 (SD:3) years. Caregivers reported worse scores than the child across all
domains, though differences were only significant for physical function, pain interference,
and anger (all p≤0.01). Physical function and anger had the largest mean differences
at 2.5 and 2.6 points, respectively. Effect sizes ranged from 0.03 (depression) to
0.29 (physical function), with most domains displaying small bias. Kappa values showed
moderate to substantial agreement and ranged from 0.52 (pain interference) to 0.69
(depression). Similarly, ICCs were all of moderate agreement and ranged from 0.51
(pain interference) to 0.69 (depression). Concordance rates by severity groups were
generally high with 9% (pain) to 19% (peer relationships) of pairs discordant.
Conclusions
This study provides support for the use of proxy PROMIS physical function, depression,
peer relationships, pain interference, and anger scales in pediatric burn patients.
Mean differences between self- and proxy-reports were generally small across all domains
and agreement was moderate to substantial. Providers need to be aware that caregivers
typically report slightly worse symptoms across all domains compared to child reports.
145-P. Enhanced patient reported outcomes to support availability of comprehensive
data for telehealth visits during COVID - 19
Susan Metzger, Kayla Wilbur, Kristina Davis
All authors: Northwestern Medicine, Chicago, IL, USA
Correspondence: Susan Metzger (susan.metzger@nm.org)
Background
In the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) of Northwestern Medicine,
patient-reported outcome measures (PROMs) integrate into the electronic health record
(EHR) to measure patient distress. Patients complete PROMs to screen for anxiety,
depression, fatigue, pain, physical function, and supportive care needs. Patients
with active electronic patient portal accounts (MyChart) complete the PROMs on a smart
phone, tablet, or computer. Some patients (16%) decline or do not activate MyChart.
Prior to the COVID-19 pandemic, clinics utilized an iPad or workstation to assist
those patients in completion at the time of the visit. This workflow was no longer
feasible with increased telehealth visits, leaving patients at high risk of having
unidentified distress.
Objective
Develop an outreach method to aide patients at RHLCCC of Northwestern Medicine in
completing PROMs remotely. Capturing PROMs data is of particular importance to clinicians
who are not able to examine the patient during a telehealth visit.
Methods
Assisted non-active MyChart patients with upcoming appointments in completing PROMs
telephonically during outreach calls. Responses were submitted directly into the EHR.
Key workflow components included increasing patient engagement by providing education
on PROMs and MyChart and assisting in MyChart enrollment.
Results
In total, 869 appointments were identified for outreach calls from March 30 thru June
2020. Throughout the timeframe, 172 (20%) PROMS were completed, 59 (33%) patients
agreed to activate their MyChart, and of those who agreed to activate their MyChart,
28 (47%) completed enrollment. To date, 21 (75%) of those who completed enrollment
demonstrated continued portal activity, including but not limited to reviewing test
results, clinical questions, and additional PROM completion.
Conclusions
The COVD-19 pandemic led to a disruption of clinic flow in the RHLCCC of Northwestern
Medicine, preventing in person assistance with PROMs completion. Telephone outreach
captured data that otherwise would have been missed in elderly and minority patients
without means, ability, or access to the electronic MyChart portal. Although too early
to measure the impact of telephone outreach on overall PROM completion rates, increase
in patient engagement and enrollment on MyChart is vital to the distress screening
process.
146-P. Is PROMIS a useful outcomes tool for children with Arthrogryposis?
Kelsey L. Millar1, M. Claire Manske1,2, Michelle A. James1,2
1University of California Davis School of Medicine, Sacramento CA;2Shriners Hospitals
for Children Northern California, Sacramento CA
Correspondence: Kelsey L. Millar (klmillar@ucdavis.edu)
Objective
Arthrogryposis is a potentially disabling congenital condition characterized by contractures
of the extremities due to lack of muscle development. Our objective was to determine
whether Patient Reported Outcome Measurement Information System (PROMIS) scores would
discriminate between children with arthrogryposis and the general pediatric population.
We hypothesized that children with arthrogryposis would report impaired Upper Extremity
Function and Mobility, but normal Pain Interference and Peer Relationships scores
compared to the reference population.
Methods
This is a retrospective cohort study of children with arthrogryposis aged 5-17 years
who responded to four pediatric PROMIS domain questionnaires (Mobility, Upper Extremity
(UE) Function, Pain Interference, and Peer Relationships) during outpatient visits
to Shriners Hospital Northern California between April 2017 and May 2019. Responses
were converted to a T-score for comparison to a reference pediatric population (mean
reference score = 50, standard deviation = 10). For Mobility, UE Function, and Peer
Relationships, a T-score ≥ 50 is within normal limits; 40-49 = mild impairment; 30-39
= moderate impairment, and 0-29 = severe impairment. For Pain Interference, a T-score
≤ 49 is within normal limits; 50-59 = mild, 60-69 = moderate, and 70-78 = severe impairment.
Results
PROMIS questionnaires were administered to 68 children with arthrogryposis (34 boys,
34 girls) with a mean age of 9.8 years (S.D. 3.8 years). They reported moderately
impaired Mobility (38.0±8.9) and UE Function (31.8±12.2), both significantly different
than the reference population (p<0.00001). 66% reported moderate or severe impairment
with Mobility, and 74% rated their UE Function impairment as moderate or severe. Participants’
Peer Relationship scores were high (54.0±8.3). 97% reported excellent or good Peer
Relationships, and 3% reported them as fair. Participants reported normal Pain Interference
(49.3±10.0), which was not significantly different than the reference population (p=0.709).
81% reported normal or mild Pain Interference.
Conclusions
PROMIS effectively discriminates between children with arthrogryposis and the general
population. Children with arthrogryposis report moderately impaired Mobility and UE
Function but similar Peer Relationships and Pain Interference in comparison to the
reference population. PROMIS is a useful tool to evaluate and understand the challenges
that children with arthrogryposis face with respect to their mobility, UE function,
peer relationships, and pain interference with activity.
147-O. PROMIS Pain Interference scores and Health-Related Quality of Life in patients
with end-stage kidney disease
Istvan Mucsi1, Tibyan Ahmed1, Aysha Afzal1, Eric Lui1, Noshin Ullah1, Jessica Li1,
Susan J. Bartlett3, Madeline Li4, Doris Howell5, John Devin Peipert6, Marta Novak2
1Multi-Organ Transplant Program and Division of Nephrology, University Health Network,
Toronto, Canada; 2Centre for Mental Health, University Health Network, Toronto, ON,
Canada; 3Center for Health Outcomes Research, McGill University, Montreal, Quebec,
Canada; 4Department of Supportive Care, Princess Margaret Hospital, Toronto, Ontario,
Canada; 5Princess Margaret Cancer Center, Faculty of Nursing, University of Toronto,
Toronto, Ontario, Canada; 6Department of Medical Social Sciences, Northwestern University
Feinberg School of Medicine, Chicago, Illinois
Correspondence: Istvan Mucsi (Istvan.mucsi@utoronto.ca)
Objective
Chronic pain is highly prevalent in patients with end stage kidney disease (ESKD).
However, its association with health-related quality of life (HRQoL) among Canadian
patients is not fully understood. The US NIH-funded Patient Reported Outcomes Measurement
Information System (PROMIS) program has developed and validated tools to assess physical,
emotional and social domains across chronic illnesses. The objective of this study
was to assess the association of pain interference with HRQoL among patients with
ESKD.
Methods
Adults with ESKD (dialysis and kidney transplant) completed PROMIS Pain Interference
Item Bank, the EuroQOL (EQ-5D-5L) and the SF-12 questionnaires. Sociodemographic and
relevant clinical data were collected from medical records. Participants indicated
pain interference (exposure), according to the PROMIS T-score metric (range 38-80),
with higher score indicating more pain interference. The Canadian valuation set was
used to obtain EQ5D5L health utility scores (0-1, 1=best possible health, 0=worst
possible health/death). The SF-12 questionnaire, yields a physical component summary
(PCS) and mental component summary (MCS) (range 0-100) score, with higher scores indicating
better HRQoL.
Results
Mean (SD) age (n=523) was 57(17) years. Fifty-seven percent were male, 49% were White
(251), 40% were on dialysis, 37% had diabetes. Higher PROMIS pain interference scores
were significantly associated with lower HRQoL as measured by the EQ-5D-5L [β= -0.008,
95% [CI]=-0.010, -0.006], p <0.001) after adjusting for age, sex, marital status,
education, income, ethnicity, comorbidity, diabetes, renal replacement therapy and
additional PROMIS domains such as sleep disturbance and depression. Pain interference
was also significantly associated with worse physical (-0.663 [-0.805, -0.521], p<0.001)
and mental (-0.184 [-0.291, -0.077], p<0.001) HRQoL in similar multivariable quantile
regression models.
Conclusions
PROMIS pain interference score was strongly associated with HRQoL. Future research
should assess if PROMIS guided screening may improve pain management and HRQoL in
patients with ESKD.
148-P. PROMIS in clinical practice: Results of qualitative interviews with patients
completing patient-reported outcomes
Therese A. Nelson1, Faraz S. Ahmad1,2, Martha-Margaret Cotton2, Kristina Davis2, Leilani
Lacson1, Ryan Merkow1,2, Luke V. Rasmussen1, Nan E. Rothrock1, Justin B. Starren1
1Northwestern University, Chicago, Illinois; 2Northwestern Medicine, Chicago, Illinois
Correspondence: Therese Nelson (therese.nelson@northwestern.edu)
Objective
Patient-Reported Outcomes (PROs) can elevate the patient voice, but given their more
recent introduction into clinical care, it is unclear how patients view PRO questionnaires
and why patients often fail to complete them. This presentation will share the patient
view of PROs, identified challenges, and a prioritized list of recommendations.
Methods
The Electronic Health Record (EHR) Access to Seamless Integration of PROMIS (EASI-PRO)
consortium consists of nine universities integrating PROMIS into EHRs. EASI-PRO researchers
conducted 23 patient interviews across four clinics at one site. Transcripts were
reviewed to examine patient experiences regarding PRO completion, reactions to PRO
questions, and physician interaction.
Results
Barriers to completion included lack of patient portal access, email overload, confusion
between PROs and healthcare satisfaction surveys, challenging physical health, and
technical factors. Patients described their experience interpreting email prompts
and advised how to make PRO requests more likely to be answered. Patients expressed
confusion regarding the purpose of PROs and how they would be used and voiced a desire
to learn how results would impact their clinical care. Patients reported that PRO
measures themselves were generally understandable but could sometimes be unclear.
Their length and content were appropriate. Comments demonstrated the importance of
selecting PRO measures that are highly relevant to the patient population, and that
completing PRO measures can result in feelings of introspection and gratitude. Patients
expressed a strong desire for quick communication of concerning scores and hope that
physicians would utilize PRO results to enhance their care. Many patients assumed
that the physician would take their PRO results into account and use results to prepare
for their medical appointments.
Conclusions
In our study, most patients were quite willing to complete PROs, but barriers to completion
hampered their response. We will present practical recommendations to address barriers,
such as revising the call center script, setting tablets at maximum time-out, communicating
expected PRO completion time, informing patients about the purpose of PROs, and refraining
from using the word “survey.” Recommendations also focus on patient desires concerning
use of PROs in patient care, encouraging clinicians to acknowledge PRO completion
and use in the clinical setting.
149-P. Premorbid PROMIS® measures and onset of Multiple Sclerosis
Pamela Newland1, Karlie Lading1 Ling Chen2
1Goldfarb School of Nursing at Barnes Jewish College; 2Washington University St Louis
Correspondence: Pamela Newland (Pamela.newland@barnesjewishcollege.edu)
Objective
Depression is a common symptom of multiple sclerosis (MS) that has been predicted
by a variety of demographic and clinical variables and other symptoms. However, it
is unclear if depression is a premorbid symptom prior to diagnosis of MS and its role
in clinical decision making. We utilized a large clinical database to enable cross
linkage with PROMIS scales and clinical variables of MS.
Method
The data network of a large academic center was evaluated to extract PROMIS and other
identified variables in both inpatient and outpatients with MS. Keywords were PROMIS,
Pain Interference, Anxiety, Depression, and Physical Function with clinical variables
of medications for fatigue, year of diagnosis, and diagnosis code for MS (ICD 9 240/ICD
10 G35).
Results
Data were available from 260 visits on 66 patients with MS. Patients were predominantly
female (61%) and white (90 %) with an average age of 51. PROMIS core item banks were
completed by all patients. The year of diagnosis ranged from 1 to 23 years. PROMIS
Depression assessment score ranged from 34 to 60 t score.
Conclusions
The current work highlights the possible role of premorbid depression as a precursor
for disease onset in patients with MS. Additional research is necessary related to
the use of PROMIS Depression and other symptom measures in medical decision making
for treatment modalities.
150-P. Mindfulness art-based therapy - PROMIS Fatigue and influence of Multiple Sclerosis
and Global-a pilot study
Pamela Newland1, Karlie Lading1, B Ann Bettencourt2, Verna Hendricks-Ferguson3
1Goldfarb School of Nursing at Barnes Jewish College 2 University of Missouri Columbia,
3Saint Louis University
Correspondence: Pamela Newland (Pamela.newland@barnesjewishcollege.edu)
Objective
Fatigue is a prevalent symptom in patients with multiple sclerosis (MS). Complementary
therapies such as mindfulness-based art therapies (MBAT) has potential to minimize
fatigue and improve global health. Information is lacking on the patient’s perspective
using patient reported outcomes. To determine the patient perspective related to use
of mindfulness- based art therapy to improve patient reported outcomes of fatigue
and global health.
Methods
Community dwelling participants with multiple sclerosis (MS) completed two measures
at one time point (i.e., PROMIS Fatigue SF and Global Health were completed). Mean
population scoring on each module is defined at 50. Participants also completed a
demographic survey that included clinical variables. Bivariate Spearman correlation
analysis defined the association between the PROMIS modules and time since diagnosis
(in years).
Results
Twelve participants with MS took part in the study. All the participants were white,
women, average age 48 years, and married, with some college (ranged from 13 to 21
years); and employed. Mean SF and Global scores were similar to values found for MS
participants in other studies (39, 30 respectively). The PROMIS Fatigue Scale SF correlated
with time since diagnosis (p < .04). There was no correlation between the PROMIS Global
LE score and PROMIS Fatigue (p <. 57).
Conclusions
The PROMIS Fatigue SF and global health is a useful tool in participants with MS to
provide their perspective of symptoms and global health who used MBAT. Further research
is needed for follow up the effectiveness of MBAT on fatigue and global health using
patient reported outcomes.
151-O. Increasing test efficiency in between-item multidimensional computerized adaptive
testing by aligning item selection and stopping rules
Muirne C. S. Paap1,2, Johan Braeken3
1Oslo University Hospital, 2University of Groningen, 3University of Oslo Abstract
Correspondence: Muirne C. S. Paap (m.c.s.paap@rug.nl)
Objective
Fixed-precision between-item multidimensional computerized adaptive tests (MCATs)
are becoming increasingly popular. The current generation of item selection rules
used in these types of MCATs typically optimize a single-valued objective criterion
for multivariate precision (e.g. Fisher information volume). In contrast, when all
dimensions are of interest, the stopping rule is typically defined in terms of a required
fixed marginal precision per dimension. This asymmetry between multivariate precision
for selection and marginal precision for stopping, has received little attention thus
far.
Methods
In this presentation, aforementioned selection-stopping asymmetry and its consequences
will be discussed, and alternative item selection approaches will be introduced and
evaluated. An empirical multidimensional item bank of 194 polytomous items, designed
to measure different aspects of quality of life was used as a basis for the simulation
study. Four dimensions were measured, using three PROMIS item banks and an additional
disease-specific item bank: fatigue (50 items), COPD-specific complaints (46 items),
physical function (63 items), and social roles and activities (35 items). The bank
was calibrated using a between-item multidimensional graded response model. Higher
scores were indicative of higher quality of life for all dimensions. All dimensions
were highly positively correlated, and items had high discrimination parameters. The
threshold parameters covered a wide range for each dimension.
Results
For all but two selection rules, the CAT algorithm reached a proper stop for 100%
of the N = 10000 simulees. The longest average total test length was found for the
traditional D-rule (12 items), the shortest test length was found for ‘restricted’
and ‘filtered’ item selection rules (7 items); here, items from dimensions for which
the required fixed-precision threshold was already met were no longer selected. The
traditional rules did not outperform unidimensional CAT in terms of efficiency. For
extreme theta values, bias was larger for selection rules that were associated with
the shortest tests. Results regarding item usage will be presented as well.
Conclusions
Using selection rules which incorporate knowledge on which of the dimensions already
meet the required fixed-precision threshold can be expected to result in shorter test
lengths for fixed marginal precision MCATs.
152-P. Culture in play: spotlighting the universal French translation and linguistic
validation of PROMIS item banks
Emily Parks-Vernizzi1, Barbara Perez1, Benjamin Arnold1, Abigail Boucher1, Helena
Correia3, Mushirah Hossenbaccus2, Sara Ahmed2†, Susan Bartlett2†
†Sara Ahmed and Susan Bartlett are co-senior authors
1FACITtrans, Ponte Vedra, FL, USA; 2McGill Center for Health Measurement, McGill Medicine,
Division of Clinical Epidemiology & MUHC Center for Outcomes Research & Evaluation,
Montréal, QC, Canada; 3Northwestern University Feinberg School of Medicine, Department
of Medical Social Sciences, Evanston, IL, USA
Correspondence: Emily Parks-Vernizzi, (eparks@facit.org)
Objective
The purpose of this study was to translate and linguistically validate 20 PROMIS®
adult item banks into Universal French and highlight cultural nuances arising during
the translation process.
Methods
We translated nearly 600 PROMIS items using the FACIT universal methodology – a standardized
iterative process of forward- and back-translation, expert review, harmonization and
cognitive interviewing. All members of the translation team were native French-speakers
from Belgium, Canada, France, and Switzerland. French-speaking community participants
in Canada assessed the relevance, understandability, and appropriateness of the translations.
A pragmatic qualitative analyses of cognitive interviews of each translated item was
used to identify conceptual and linguistic differences between cultures.
Results
The study sample consisted of native French-speaking adults (57 women, 23 men) in
Montreal, Canada with a mean age of 37 (20-72). Conceptual and linguistic differences
were evident for specific physical (“achy” Pain Quality–Nociceptive; “bushed” and
“wiped out” Fatigue; and “do a pull-up” Physical Function); emotional (“angry” Depression);
and social (“I have trouble” Ability to Participate; “people are around me but not
with me” Social Isolation and “sense of purpose” Psychosocial Illness Impact – Positive)
items. Interview data revealed that 580 items of the 593 considered items required
no revisions. Of the concepts discussed here, only 11 items required iterations to
improve conceptual equivalence and two items were revised to accurately reflect the
English source.
Conclusions
Translating complete PROMIS items banks reveals that while most PROMIS domains are
conceptualized and described similarly across cultures, a few items require additional
exploration to ensure equivalence. PROMIS universal French item banks in this study
are conceptually equivalent to the English source and acceptable for use in international
research and clinical trials. Cognitive interviewing in other French-speaking regions
is planned. Structured qualitative interviews are essential to assuring the validity
of translated items.
153-P. Responsiveness of PROMIS short forms among adult cancer patients
John Devin Peipert1, Paul Novotny2, Amylou C Dueck3, Minji Lee2,, Timothy J Beebe4,
Marlene Frost2, Kathleen Yost2, David Eton2, Susan Yount1, Jennifer Beaumont5, Tito
R; Mendoza6, Charles S Cleeland6, Victoria Blinder7, Ethan Basch8, Jeff Sloan2, David
Cella1
1Northwestern University, Department of Medical Social Sciences; 2Mayo Clinic, Rochester,
MN; 3Mayo Clinic, Scottsdale, AZ; 4 University of Minnesota, Minneapolis, MN; 5Clinical
Outcome Solutions, Los Angeles, CA; 6University of Texas M. D. Anderson Cancer Center,
Houston, TX; 7Memorial Sloan Kettering Cancer Center, New York, NY; 8University of
North Carolina, Chapel Hill, NC
Correspondence: John Devin Peipert (john.peipert@northwestern.edu)
Objective
The ability of a patient reported outcome measure to reflect changes in health is
necessary to support its use in trials and clinical patient monitoring. Though PROMIS
measures are commonly used among cancer patients, the responsiveness of some commonly-used
PROMIS short forms has not been established among this population.
Methods
We used data from a prospective, observational study of 1828 cancer patients. Each
participant was surveyed at a baseline timepoint and 6 weeks later on several PROMIS
domains, including several short forms of differing lengths within some domains: Physical
Function (10a), Anxiety (4a, 6a, 8a), Depression (4a, 6a, 8a), Ability to Participate
in Social Roles and Activities (4a, 6a, 8a), Sleep Disturbance (4a, 6a, 8a), Fatigue
(7a), Pain Intensity (3a), and Pain Interference (7 item custom short form). Each
was scored on a T score metric (mean = 50, SD = 10). We used mixed effects models
to estimate the least squares mean change for each short form. Domain specific ratings
of change were assessed (e.g., change in physical function over past 6 weeks) and
used to categorize change as “better,” “same,” or “worse.” For these groups, we calculated
PROMIS change scores. Then we calculated standardized response means (SRM) for each
group. SRMs of 0.30 or above were considered evidence of responsiveness.
Results
Participants were on average 56 years of age, most often had an ECOG performance status
rating of 0 or 1 (71%), and the most common cancer types were breast (26%) and lymphoma/myeloma
(21%). Estimated changes in PROMIS scores were most often between 1 and 2.5 T score
points. While SRMs for the “better” and “same” change groups were small, those for
the “worse” group always exceeded the 0.30 (range: 0.69-0.94). Notably, for domains
with multiple short forms, scale length did not affect responsiveness (e.g., Anxiety
4a SRM = 0.69; 6a SRM = 0.69; 8a SRM = 0.70).
Conclusions
PROMIS short forms for multiple domains were highly responsive to change in health
among a diverse sample of cancer patients. Instruments with more items were not more
responsive, indicating the utility of even brief PROMIS assessments.
154-O. PROMIS-29 domains associated with dissatisfaction in spine surgery patients
who improve in pain and functioning
Jacquelyn S. Pennings1,2, Rogelio A. Coronado1,2, Inamullah Khan1, Anthony L. Asher3,
Mohamad Bydon4, Clinton J. Devin5, Kristin R. Archer1
1Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville,
USA; 2Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical
Center, Nashville, TN; 3Carolina Neurosurgery and Spine Associates, Charlotte, USA;
4Department of Neurologic Surgery, Mayo Clinic, Rochester, USA; 5Steamboat Orthopaedic
and Spine Institute, Steamboat Springs, USA
Correspondence: Jacquelyn S. Pennings (jacquelyn.pennings@vumc.org)
Objective
Patient satisfaction is important when evaluating the success of spine surgery. A
subset of patients have clinically relevant improvements in disability/pain but report
being dissatisfied with surgery. The aim was to evaluate whether changes in mental
health (depression and anxiety) and social (ability to participate in social roles
[SR]) domains of the PROMIS-29 were associated with dissatisfaction at 1-year after
spinal surgery for patients who achieve clinical improvement in disability or extremity
pain.
Methods
The study was a retrospective analysis of data collected between 2018-2019 from a
prospective spine surgery registry, Quality Outcomes Database. Participants completed
the PROMIS-29, ODI, and back/leg NRS pain ratings preoperatively and 1-year after
surgery. Patient demographic and clinical characteristics were collected from medical
records and patient interviews. Satisfaction was assessed at 1-year with 1-item from
the NASS lumbar spine outcome assessment. Participants (N=369) undergoing elective
surgery for degenerative spine conditions and having a successful outcome (achieving
at least 30% improvement in disability or leg pain) 1- year after surgery were included.
Logistic regression predicted dissatisfaction at 1-year from PROMIS-29 domain T-scores
(SR, anxiety, depression) at 12 months. Covariates included demographic, clinical,
surgical characteristics, preoperative PROMIS scores and disability, and postoperative
complications and revision surgery after surgery.
Results
A total of 116 participants (31%) with clinical improvement in disability or leg pain
reported being dissatisfied at 1-year after surgery. When controlling for baseline
scores, ability to participate in social roles (OR=0.87, 95%CI=0.84-0.90, p<0.001),
depression (OR=1.09, 95%CI=1.06-1.13, p<0.001), and anxiety (OR=1.05, 95%CI=1.02-1.07,
p<0.001) at 12 months were all significantly associated with dissatisfaction at 1-year
post surgery. None of the preoperative PROMIS domains were associated with dissatisfaction
at 1-year (p < 0.05).
Conclusions
12-month PROMIS scores were significantly associated with dissatisfaction indicating
that patients with who had less improvement in social activities, depression, and
anxiety tended to report being dissatisfied even after having a clinically relevant
improvement in disability/pain. Preoperatively, none of these PROMIS scores were associated
with dissatisfaction at 1-year. The results indicate that improvements in social and
mental health factors play a role in patient satisfaction after lumbar spine surgery
along with improvements in disability and pain.
155-O. Withdrawn
156-P. Patient reported outcomes after risk-reducing gynecologic surgery for hereditary
breast and ovarian cancer syndromes
Lauren Philp1, Stephanie Alimena2, Mackenzie Sullivan2, Whitfield B Growdon1, Amy
J Bregar1, Thomas Randall1, Katelyn Dorney1, Annekathryn Goodman1, Eric Eisenhauer1,
Marcela del Carmen1, Rachel Clark Sisodia1
1Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Massachusetts
General Hospital, Boston, MA; 2Department of Obstetrics and Gynecology, Massachusetts
General Hospital and Brigham and Women’s Hospital, Boston, MA
Correspondence: Lauren Philp (lphilp@mgh.harvard.edu)
Objective
To determine the impact of risk-reducing gynecologic surgery (RRGS) on the health-care
quality of life (QOL) of women with hereditary breast and ovarian cancer syndromes
(HBOCS) and to compare these outcomes to patients with benign and malignant ovarian
disease.
Methods
Patient reported outcome (PRO) collection was implemented at our gynecologic oncology
clinic in January 2018. At serial visits, patients were administered general and disease
specific PRO measures (PROMs) based on patient disease site. Cohorts of patients with
ovarian cancer (OC), HBOCS or benign ovarian masses (BOM) were identified and additional
clinical and surgical characteristics were collected prospectively. Specific PROM
questions reflecting important physical and psychosocial outcomes were selected a-priori
from questionnaires for analysis. Over the study period, both first and last and pre-
and post-operative PROM responses were described and compared between cohorts.
Outcomes
Between January 2018 and October 2019, 150 HBOCS patients, 209 BOM patients and 329
OC patients were identified. In the HBOCS cohort, PROM responders were similar to
non- responders, however, were significantly younger than OC responders (p<0.001).
During the study period, 24.7% of HBOCS patients had RRGS. Post-operatively, patients
reported feeling less tense (p=0.034) and less worried about future health (p=0.020)
but did report more difficulty sleeping (p=0.011), less interest in sex (p=0.025)
but no changes in body image. Patients did not report feeling burdened by their treatment.
When first and last PROM responses were compared in the HBOCS patients who did not
have RRGS, no significant changes were noted. When first PROM responses were compared
between cohorts, HBOCS and BOM patients were similar however HBOCS patients reported
better QOL (p=0.015) and overall health (p=0.008).OC patients reported the worst QOL
(p=0.008), highest levels of worry (p=0.048) and treatment burden (p<0.001), lowest
overall health (p=0.003) and highest disease interference in their family life (p=0.003),
social life (p<0.001) and finances (p=0.008). When last PROM responses were compared
between groups, a similar trend was noted.
Conclusion
Patients with HBOCS report overall good QOL after RRGS and better QOL than patients
with ovarian malignancies. These results can help to guide counselling for patients
with HBOCS and to address their unique health-care needs.
157-P. Validation after translation of PROMIS-57 Profile Norwegian with factor analysis,
IRT and DIF analysis
Stein Arne Rimehaug1, Aaron James Kaat2, Jan Egil Nordvik3
1University of Oslo, Norway, 2Nortwestern University, Chicago IL; 3Sunnaas hospital,
Oslo
Correspondence: Stein Arne Rimehaug (stein.arne.rimehaug@sunnaas.no)
Objective
Cross-sectional reliability and validation after translation of seven PROMIS® Short
forms in a Norwegian general population, n=408.
Methods
Anonymous, voluntary online collection of demographics, RAND36 and PROMIS57 (including
8-item short forms for physical function, anxiety, depression, fatigue, sleep disturbance,
ability to participate in social roles and activities, and pain interference). Analysis:
Correlations against similar/dissimilar domains in PROMIS57 and RAND36, bi-factor,
EFA, CFA and Mokken analysis checking factor structure and IRT assumptions. IRT Graded
Response model: Item and model fit, ICC, TIF and SE plots. DIF analysis in lordif
(R) with ChiSquare and McFadden R2 methods for language DIF against Wave1 and ProfilesHUI
datasets, and demographic DIF.
Results
Reliability>.9, concurrent validity correlations .7-.9 and discriminant correlations
.4-.7. CFA 7-factor with WLSMV estimator results in scaled model fit indices of: RMSEA=.05,
CFI=.99, TLI =.99 supporting the structural validity. First factor eigenvalue ratios
from bi-factor analysis between 4:1 (Sleep) and 32:1 (Social), and Estimated Common
Variance (ECV) per domain between 86 and 96 (>60 supports unidimensionality). Local
Dependence: 4 or less out of 196 possible item pairs flagged with CFA residuals >.2,
or IRT Chen&Thissen LD index >.3. Only two misfitting items (Sleep 44 and 72), based
on s-x2. Graded Response model fit: RMSEA=.13, SRMSR: .14, TLI and CFI: .96., and
acceptable IRT plots. Scores in this general population sample are skewed and zero-inflated.
Sample: 74% women, mean age 52.
Conclusions
For each domain (=short form) excellent reliability, and concurrent and discriminant
validity. Factor structure of PROMIS 57 seven domains confirmed. IRT assumptions are
met for unidimensionality, local independence, monotonicity and invariance (=no language
DIF, age, gender or education DIF). Issues: very high discrimination parameters may
be related to skewed/zero-inflated distribution, sub-threshold LD/dimensionality issues,
and sample size. Lessons learned: obtain a larger and more diverse sample for IRT
and DIF. Translate and assess entire item banks at once, rather than profiles and
short forms.
158-P. Word selection for translating PROMIS® Fatigue items, using a lay person panel
Stein Arne Rimehaug stein.arne.rimehaug@sunnaas.no
University of Oslo and Sunnaas Rehabilitation Hospital, Norway
Objective
To systematically translate words indicating varying degrees of fatigue in the PROMIS
Item bank with the help of lay person input.
Methods
Comparing the rank order of available words expressing different degrees of fatigue
in Norwegian by asking a small cognitive debriefing panel, n=5, to rate each expression
on a 10-point NRS scale. The rank order and standard deviation for each expression
helps indicate which words should match the severity of each English language counterpart
in the PROMIS Fatigue Item Bank.
Results
14 words/expressions tested. Agreement among blinded participant, median SD 1.3 on
a 10point scale. Useful supplement to expert and translator opinion. The resulting
ranking could not be used directly for word selection, as the semantic meaning not
always matched. Also some words are already translated by FACITrans in FACT or NeuroQol
items.
Conclusions
Many PROMIS fatigue items hinge the severity onto a single word or expression, to
a greater degree than other short forms and item banks. While translating the Fatigue
short form, we wished to avoid making word choices that would “use up” words that
woulfd be a better fit later for other items in the bank. This ranking by a panel
helped inform the process, though the panel perhaps should have had more respondents.
159-P. PROMIS sleep disturbance and sleep-related impairment item banks in the Dutch
general population
CB Terwee1, M Avetisyan1, MHP Crins2, LD Roorda2
1Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics,
Amsterdam Public Health Research Institute, Boelelaan 1117, Amsterdam, the Netherlands;
2Amsterdam Rehabilitation Research Center | Reade, Amsterdam, the Netherlands;
Correspondence: Leo Roorda, (leo.d.roorda.research@gmail.com)
Objective
The Patient-Reported Outcomes Measurement Information System (PROMIS®) v1.0 item banks
‘Sleep Disturbance’ (SD, 27 items) and ‘Sleep-Related Impairment’ (SRI, 16 items)
were developed to measure self-reported aspects of sleepiness, sleep quality, and
functional impact of sleep problems more efficiently and precisely than current instruments,
by using Computerized Adaptive Testing (CAT). We validated these item banks in a Dutch
general population.
Methods
Participants in an internet panel completed both item banks. Unidimensionality, local
dependence, monotonicity, Graded Response Model (GRM) item fit, Differential Item
Functioning (DIF) for age, gender, education, region, ethnicity, and language (Dutch
compared to US Wave 1 data), and reliability were assessed.
Results
A representative Dutch sample of 1006 people participated. We found sufficient unidimensionality
for the both item banks (SD: CFI=0.93, TLI=0.92, RMSEA=0.13, Omega H=0.80, ECV=0.69;
SRI: CFI=0.96, TLI=0.95, RMSEA=0.17, Omega H=0.85, ECV=0.76). Some local dependence
was found (SD: 4.8%; SRI: 0.8% item-pair correlations>0.20), sufficient monotonicity
(SD: H=0.60; SRI: H=0.65), and good IRT item fit (SD: zero out of 27 items with S-X2
p-value <0.001; SRI: two out of 16 items). For SD DIF for age was found for four items;
younger persons report more sleep problems compared to older persons with similar
levels of sleep disturbances. No DIF was found for SRI. We found a reliability of
at least 0.90 with simulated CATs (based on US item parameters) in 96% of the participants
with on average 4.5 (range 2-12) items for SD and 75% of the participants with on
average 6.2 (range 3-12) items for SRI.
Conclusion
The PROMIS sleep item banks showed sufficient psychometric properties in a general
Dutch population and can be used as CAT. PROMIS CATs allow reliable and valid measurement
in an efficient and user-friendly way with limited administration time.
160-O. Reducing patient and provider burden: methodology for automated collection
of PROMIS CAT in EPIC
Stacy Schmitt1, Martha Springsted1, William Mauck, MD2, Andrea Cheville3, Timothy
Maus4
1Mayo clinic Rochester, MN Multidisciplinary Spine Center; 2Departments of Anesthesiology;
3Physical Medicine; 4Rehabilitation, and Radiology
Correspondence: Stacy Schmitt (Schmitt.Stacy@mayo.edu)
Objective
Stakeholder burden is an obstacle to patient reported outcomes (PROs) data collection
across the continuum of spine care. The objective is to describe methods to automate
administration of 8 PROMIS domains via computer adaptive testing (CAT) within the
Epic electronic health record (EHR) throughout a high volume, multisite regional spine
care practice to improve patient response rates and unbiased outcome assessment.
Methods
Collaborative efforts between 11 Mayo spine care provider specialties (representing
over 1,000 providers), project managers, and EPIC data architects provided the architect
team an understanding of clinical and research requirements for data collection. Iterative
builds and testing of code ensued.
Results
Consensus was achieved among all spine care providers to move from legacy instruments
to 8 PROMIS domains assessed via CAT. Anchor events (EPIC defined visit types, procedure
and surgical codes) were used as triggers to initiate a predefined cadence (baseline,
3, 6, 12, 24…60 months) of PROMIS CAT assignments. EHR logic was developed to automatically
cease data collection and re-initiate the baseline and cadence collection as the patient
traversed diverse spine care trajectories potentially including primary care, spine
specialty care, interventional pain procedures, and surgery. PRO collection modes
include: electronic patient portal > on-site tablet > interactive voice response >
manual phone contacts. Epic reports were parameterized to assess patient response
rates on a clinical site-specific basis for quality assurance and to direct efforts
to improve response rates. An Epic registry and dashboard were created to display
longitudinal patient-level and aggregated data. Epic’s registry function integrated
clinical, laboratory, imaging and surgical data with the PROMIS data. Artificial intelligence
and conventional analytic efforts are planned to identify and validate patient phenotypes
that predict care trajectories and may be used to inform shared and clinical decision
making.
Conclusions
A system was created in the Epic EHR for automated CAT assessment of PROMIS domains
in order to measure the effectiveness of intensity and sequence of spine care in a
quaternary, regional health system. Patient response rates distinguished by site of
care, mechanism of data collection, and follow up interval will be presented, along
with Epic display and analysis tools.
161-O. Incorporating PROMIS into the CIBMTR hematopoietic cell transplant outcomes
registry
Bronwen E Shaw1, Deborah Mattila2, Linda J Burns1, Ruta Brazauskas1, Erin Leckrone2,
Rachel Cusatis1, Kathryn E Flynn1
1CIBMTR, Froedtert and the Medical College of Wisconsin, Milwaukee, USA; 2CIBMTR,
NMDP/BetheMatch, Minneapolis, USA
Correspondence: Bronwen Shaw (beshaw@mcw.edu)
Objectives
Hematopoietic cell transplantation (HCT) is an established therapy to treat many hematologic
diseases. The Center for International Blood and Marrow Transplant Research (CIBMTR)
is an outcome registry that has been collecting clinical outcome data for HCT recipients
for over 45 years. There are >540,000 unique patients represented in the registry
with longitudinal data collected, including demographics, exposures, clinical outcomes
and late effects, linked to bio- repository samples. Important clinical questions
using this CIBMTR data are proposed by the community and facilitated by CIBMTR scientific
and statistical experts. However, to date there is no routine collection of Patient-Reported
Outcomes (PROs). Our objective was to incorporate routine PRO collection into the
CIBMTR registry.
Methods
CIBMTR performed two studies to assess the feasibility of centralized PRO collection.
The first used pen-and-paper methodology and local consenting, the second used a bespoke
electronic (ePRO) system through which consent was obtained by CIBMTR. Both required
local site Institutional Review Board (IRB) approval (in the second for sites to provide
patient contact details to CIBMTR). The ePRO system incorporates a patient-friendly
interface in Qualtrics, an API link to the PROMIS measures delivered using CAT technology,
links to a contact management system to track and trigger PROs, and links to the CIBMTR
database to store PROs and link them to the clinical data.
Results
The first study confirmed feasibility and acceptability of centralized PRO data collection,
but highlighted barriers imposed by pen-and-paper methodology. The second study showed
successful implementation of the ePRO system with logistic efficiencies, ease of electronic
consenting and PROMIS data collection (with an average of 4.2-7.4 questions completed
in 0.7- 1.2 minutes per domain), and successful linkage with clinical data, but delays
related to local IRB approvals. To address this CIBMTR developed a mechanism to collect
patient contact details and operate the PRO collection under a single centrally IRB-approved
protocol.
Conclusions
Using these strategies, CIBMTR can now incorporate routine PROMIS PROs for HCT recipients
whose clinical data is included in the registry. This has enormous potential for future
uses of these data to answer important research questions in a real-world data setting.
162-P. PROMIS scores for children with Unilateral Congenital Below Elbow Deficiency
(UCBED)
Azarin Shoghi1, Anita Bagley1,2, Michelle A. James1,2
1Shriners Hospital for Children, Northern California (SHCNC); 2University of California,
Davis School of Medicine; Sacramento, CA, USA
Correspondence: Michelle James (MJames@shrinenet.org)
Objective
Children with UCBED are congenitally one-handed. In previous studies(1,2), they have
milder- than-expected disability. Although PROMIS discerns UE function in other congenital
arm differences(3), results for children with UCBED are not known. This study evaluates
their responses to PROMIS Short Form Upper Extremity Function (UEF), Mobility, and
Peer Relationships (PR) domains.
Methods
This is a retrospective review of children with UCBED who responded to PROMIS questions
from 4/1/17-3/31/20, by parent-proxy (5-7 years) or self-report (8-17). Responses
were converted to a T-score for comparison to a reference population. T-score≥50=normal;
40- 49=mild, 30-39=moderate, and 0-29=severe impairment.
Results
28 children/proxies completed questionnaires (mean 11±3.4 years). They scored the
same as the reference population for Mobility and PR, and reported lower UEF (43.5±9.3;
P=0.02). 5-7 year-olds (5 children) reported normal PR, mildly impaired Mobility (46.0
± 5.6), and moderately impaired UEF (30.2 ± 3.5; P=0.003); 8-12 year-olds (13) reported
normal PR and Mobility and moderately impaired UEF (42.7±8.0). 13-17 year-olds (10)
reported normal outcomes on all three domains.
Conclusions
1. Impairment measured by PROMIS is similar to previous studies for children with
UCBED.
2. 5-7 year-olds reported lower UEF scores; short Form UEF tasks may be too difficult,
and/or parents may under-report function (4). A study of typically developing 5-7
year- olds is underway to determine whether the UEF Short Form questions have a floor
effect for this age group.
3. PROMIS UEF may have a ceiling effect for older children with UCBED.
4. Children with UCBED have a potentially stigmatizing UE difference, but do not report
challenges with peer relationships.
References
(1) James MA et al. Impact of prostheses on function and quality of life for children
with unilateral congenital below-the-elbow deficiency. JBJS 2006; 88:2356.
(2) Bagley AM et al. The Unilateral Below Elbow Test: a function test for children
with unilateral congenital below elbow deficiency. Dev Med Child Neuro 2006; 48:569.
(3) Oishi S et al. Treatment and outcomes of arthrogryposis in the upper extremity.
Am J Med Genet 2019.
(4) Sheffler LC et al. Comparison of self-reports and parent proxy-reports of function
and quality of life of children with below-the-elbow deficiency. JBJS 2009; 91:2852.
163-P. Measurement properties of PROMIS short forms for pain and function in three
samples of orthopaedic patients
Anika Stephan1, Vincent Stadelmann1, Michael Leunig2, Franco Impellizzeri3
1Department of Teaching, Research and Development, Schulthess Clinic, Zurich, Switzerland;
2Department of Hip and Knee Surgery, Schulthess Clinic; 3Faculty of Health, University
of Technology Sydney
Correspondence: Anika Stephan, (anika.stephan@kws.ch)
Objective
The aim of this study was to evaluate the measurement properties of the German PROMIS-
short forms (SF) for pain intensity 3a (PAIN), pain interference 4a (PI) and physical
function 4a (PF) in patients undergoing total knee arthroplasty (TKA), total hip arthroplasty
(THA) or foot/ankle surgery (F/A).
Methods
PROMIS-SF data were taken from our clinic registries for the respective patient groups
pre-, 6 and 12 months post-surgery (THA, TKA only). Higher PROMIS-SF scores indicate
more PAIN, higher PI and better PF. Main reference measures were the Oxford Knee Score
(OKS), Oxford Hip Score (OHS) and Foot Function Index (FFI-D). A subsample completed
pre-surgery or 6-month PROMIS-SF twice within 14 days to test reliability.
Results
Baseline (and longitudinal) sample sizes were: TKA, 144 (120); THA, 132 (116); F/A,
748 (202). Test-retest sample sizes ranged from 45 to 65. Correlations with reference
measures were r≥0.7 for TKA and THA, and r≥0.6 for F/A. Cronbach’s α indicated appropriate
internal consistency for all SF [0.84≤α≤0.93] in all groups. Intraclass correlation
coefficients were best for TKA (0.9-0.97), good for F/A (0.81-0.91) and acceptable
for THA (0.69-0.81). Standard errors of measurement represented the following percentages
of the mean score change: TKA, 14-23%; THA, 16-21%; F/A, 30-60%. Smallest detectable
change thresholds (SDC90) were: PAIN, 7 points (all groups); PI, 7-8 points (all groups);
PF, 8-9 points (THA, F/A); PF, 4 points (TKA). Minimal important changes could be
calculated for TKA and F/A, and were around 8-9 and 4-5 points, respectively. All
three groups showed follow-up ceiling effects (best score) in the PF scale: TKA, 30%;
THA, 66%; F/A, 41%. Correlations of PROMIS change scores with the main reference instruments’
change scores were good for TKA [0.52≤│r│≤0.65] and THA [0.73 ≤│r│≤0.8], but limited
for F/A [0.42≤│r│≤0.56].
Conclusions
PROMIS-SF of pain and function could be used in orthopaedic patients. However, the
standard error of measurement showed one to two thirds of the mean change for F/A
patients, which limits the interpretation of change. Furthermore, improvement of PF
in THA patients might be underestimated, as the follow-up PF score showed large ceiling
effects.
164-P. Predicting scores for the EORTC QLQ C-30 using linear modeling of PROMIS Global
Health responses
Yujie Sun1, Robert Feldman2, Andrew Althouse2, Dhiraj Yadav3, Anna Evans Phillips3
1Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh,
PA, USA; 2Center for Research on Health Care Data, Department of Medicine, University
of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 3Division of Gastroenterology,
Hepatology and Nutrition, Department of Medicine, University of Pittsburgh School
of Medicine, Pittsburgh, PA, USA
Correspondence: Yujie Sun (Suny4@upmc.edu)
Background
Translation of data between patient reported outcome (PRO) tools allows for pooling
and comparison of data between similar patient populations. To date there exists no
established method for prediction of European Organization for the Research and Treatment
of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scores from the Patient Reported
Outcomes Measurement Information System Global Health questionnaire (PROMIS GH). This
study’s aim was to create a prediction method for the EORTC QLQ C-30 based on PROMIS
GH responses.
Methods
The EORTC QLQ C-30 (Version 3.0) and PROMIS GH (Version 1.2) were administered prospectively
at the University of Pittsburgh Medical Center to self-described healthy subjects
who were control volunteers for a study on pancreatic pain. These subjects had neither
pancreatic disease or abdominal pain. Multivariable regression models were completed
with EORTC QLQ C-30 subscores (Quality of Life (QOL), physical, role, emotional, cognitive,
and social functioning) as dependent variables and the PROMIS items as independent
variables. Adjusted R2 and model p-value were reported for EORTC QLQ C-30 subscales.
Results
A total of 220 subjects (Mean age 43.8 ± 18 years, males n= 90 (41%)) were analyzed.
Mean composite PROMIS Mental Health T-score was 53.68 ± 9.08, and composite Physical
Health T- score was 55.68 ± 7.45, confirming healthy status of the population. Range
of mean scaled composite scores for EORTC QLQ-C30 was 84.2 ± 15.79 to 95.83 ± 12.6.
EORTC QLQ C-30 QOL score showed the highest correlation with between actual and predicted
values (adjusted R2=0.638; p<0.001). The emotional functioning subscore also showed
close correlation between observed and predicted values (adjusted R2=0.623; p<0.001).
Modest to poor correlation was seen for physical (adjusted R2=0.480), social (adjusted
R2=0.372), role (adjusted R2=0.292), and cognitive functioning scores (adjusted R2=0.289;
all p<0.001). Higher correlations between actual and predicted values were seen with
items containing direct content overlap between the two PRO tools.
Conclusion
PROMIS-GH can be used to predict EORTC QLQ C-30 QOL and emotional functioning subscore
values using linear regression modeling. Additional subscores cannot be predicted
with more than moderate correlation to actual scores due to lack of content overlap
between the PRO tools.
165-P. Common patient-reported outcomes across ICHOM standard sets – The value of
PROMIS®
Caroline B Terwee1, Marloes Zuidgeest2, Harold E Vonkeman3, David Cella4, Lotte Haverman5,
Leo D Roorda6
1Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics,
Amsterdam Public Health Research Institute, Boelelaan 1117, Amsterdam, the Netherlands;
2National Health Care Institute, Willem Dodukhof 1, Diemen-Zuid, the Netherlands;
3Department of Rheumatology and Clinical Immunology, Medisch Spectrum Twente and University
of Twente, Enschede, the Netherlands; 4Department of Medical Social Sciences, Northwestern
University Feinberg School of Medicine, Chicago, US; 5Emma Children’s Hospital Amsterdam
UMC, University of Amsterdam, Psychosocial Department, Meibergdreef 9, Amsterdam,
The Netherlands; 6Amsterdam Rehabilitation Research Center | Reade, Amsterdam, the
Netherlands
Correspondence: Caroline Terwee (cb.terwee@amsterdamumc.nl)
Objective
The International Consortium for Health Outcomes Measurement (ICHOM) develops condition-specific
Standard Sets of outcomes to be measured in clinical practice for value-based healthcare
evaluation. There are, however, large differences and inconsistencies between sets
in selected patient-reported outcomes (PROs), terms and definitions used, and recommended
patient- reported outcome measures (PROMs), even for the same PROs, which threatens
the validity and practical applicability of the ICHOM Standard Sets. It would be ideal
if common PROs would be named and defined similarly and measured with the same PROMs
across conditions. PROMIS® offers an evidence-based conceptual framework of commonly
relevant PROs and validated PROMs that are applicable across patient populations and
medical specialties. The aim of this study was to identify shared PROs across ICHOM
Standard Sets and to examine to what extend these PROs can be measured with PROMIS.
Methods
All individuals PROs and recommended PROMs were extracted from all available ICHOM
Standard Sets in January 2020. Similar PROs were categorized into unique PRO concepts.
Subsequently, it was examined which of these PRO domains can be measured with PROMIS.
Results
In 28 ICHOM Standard Sets, 182 PROs were identified. A total of 96 different PROMs
are recommended for measuring these PROs. The 182 PROs were categorized into 21 unique
PRO concepts. More than half (12/21) of these PRO concepts (covering 74% of the 182
PROs and 79% of the 96 PROMs) can be measured with a PROMIS measure. Furthermore,
inconsistencies were found in the selected PROs and PROMs across Standard Sets. It
is unclear why some PROs are included in some Standard Sets, but not in others.
Conclusion
Considerable overlap was found in PROs across ICHOM Standard Sets, and large differences
in terms used and recommended PROMs, even for the same PROs. Inconsistencies in the
selected PROs and PROMs across Standard Sets questions the validity of the Standard
Sets. We recommend a more universal and standardized approach to PRO and PROM selection,
using a common measurement system such as PROMIS, to improve the validity of outcome
measurements in clinical practice, and facilitate benchmarking, learning and improve
quality of care across patient groups.
166-P. Smallest Detectable Change (SDC) and Minimal Important Change (MIC) of PROMIS
instruments – A systematic review
CB Terwee1, JD Peipert2, R Chapman2, P Griffiths3, LB Mokkink1
1Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics,
Amsterdam Public Health Research Institute, Boelelaan 1117, Amsterdam, the Netherlands;
2Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern
University, Chicago, USA; 3 Adelphi Mill, Bollington, Cheshire, UK
Correspondence: Caroline Terwee (cb.terwee@amsterdamumc.nl)
Objective
To summarize available evidence on Smallest Detectable Change (SDC, smallest change
in score that is not due to measurement error) and Minimal Important Change (MIC,
smallest change that patients, on average, consider important) of PROMIS measures
and provide method recommendations.
Methods
A systematic PubMed search was performed to identify all studies that evaluated test-
retest reliability or estimated a MIC value of any PROMIS measure in any population.
The quality of reliability studies was assessed with the COSMIN Risk of Bias checklist
and SDC was extracted or calculated from test-retest reliability standard error of
measurement or limits of agreement. Anchor- based MIC values were extracted (which
are preferred over distribution-based methods).
Results
Twenty-five studies examined test-retest reliability. Only five studies provided evidence
on SDC, of which three were rated as doubtful or adequate quality. These three studies
reported SDC values between 7.7-16.3 T-score points for 16 PROMIS measures. Twenty-two
studies evaluated the MIC of one or more PROMIS measures, of which 16 used anchor-based
methods. MIC was most often defined as a mean change in PROMIS T-score in patients
who slightly improved on an anchor. Anchors, however, did not always measure the same
construct as the PROMIS measure and sample sizes were often small. Most MIC values
were found for adult Pain Interference (14 studies, MIC values 0.7-12.4), Physical
Function (13 studies, MIC values 0.1-12.0), Anxiety (6 studies, MIC values 0.2-8.0),
Depression (5 studies, MIC values 2.1-5.8), Fatigue (5 studies, MIC values 1.5-7.6),
Satisfaction with Social Roles and Activities (4 studies, MIC values 0.6-6.2), and
Sleep Disturbance (3 studies, MIC values 1.2-6.6). Only two studies estimated MIC
values for pediatric item banks, MIC values ranged from 0.1-12.7 T- score points.
SDC and MIC values could not directly be compared for the same PROMIS measure but
SDC values were mostly lower than MIC values.
Conclusion
Limited evidence is available on the SDC and MIC of PROMIS measures. More high quality
evidence is needed. Data from test-retest reliability studies was not optimally used
and should be re-analysed to estimate the SDC. Higher quality anchors and larger sample
sizes are needed in MIC studies.
167-O. Effectiveness of automated EMR notification for prompting provider intervention
for severe depression
Marco Castro, Mark Vrahas
Both authors: Cedars-Sinai Medical Center
Correspondence: Mark Vrahas (mark.vrahas@cshs.org)
Objective
Although there is good evidence that patient-reported outcome measures can be used
to improve patient-doctor communication, and can uncover unrecognized problems, they
are only useful if physicians use them. The purpose of this study was to determine
if simple EMR notifications would prompt providers to address severe depression when
present in their patients. In March of 2018 we initiated the routine collection of
PROMIS, Physical Function, Pain Interference, and Depression/Mood CATS in our orthopaedic
clinics. By May of 2018 we noticed that 2% of patients had Depression CAT scores consistent
with severe depression. To address this, we worked with EIS to prepare a Best Practice
Alert for patients with severe depression. An automated in-basket message was sent
to the nursing triage pool for patients with depression scores greater that 70. The
triage nurse forwarded the note to the visit provider notifying the physician of the
high score and provided resources for referring the patient to their PCP or a mental
health provider. No other notification was provided.
Methods
Between October 2018 and March 2020, 282 patients were identified as having severe
depression (PROMIS Depression CAT >70), and the responsible physician was made aware
as noted above. A retrospective quality review of progress notes to determine if providers
documented the high score and provided some intervention.
Results
The physicians documented the high score in 63 cases (22%). No mention was made of
the depression in 219 cases (78%). Interventions noted for the 63 patients, where
the physician documented the high depression score, are noted in table 1.
Discussion
A simple Best Practice Alert was not adequate to prompt physicians to document some
intervention to address their patient’s depression. Nevertheless, this simple intervention
was effective in 22% of cases. In addition, it may be possible that the physician
did indeed address the patient’s depression and just did not document it in the chart.
The mechanism to provide notification does not disrupt clinic flow in any way, and
physician education along with standard macros for documentation may greatly increase
the numbers of patients whose depression are being addressed.
Table 1 (abstract 167-O).
See text for description
Referred to
Count of MRN
%
Mental Health Provider
27
42.86%
Not specified
25
39.68%
Social Worker
5
7.94%
PCP
5
7.94%
Program or Resource
1
1.59%
Grand Total
63
168-P. Progress in clinical application of patient reported outcomes
Ying Wang, Zhixia Jiang
Both authors: Department of Nursing, Affiliated Hospital of Zunyi Medical University
Correspondence: Jamie Wang (wyjamie@126.com)
Objective
Patient-Reported Outcomes (PROs) refer to the subjective evaluation of the patient's
own health status directly from the patient. With the rapid development of medical
treatment in recent years, people are becoming more aware of the importance of patient
self-reports in clinical evaluation. The research of PROs is more and more clinically
carried out. This article is about the progress of clinical research of PROs at home
and abroad.
Methods
Search domestic and foreign databases to summarize and evaluate relevant literature.
Results
A total of 1 958 related documents were retrieved. PROs are widely used in patients
with various diseases, such as leukemia patients, lung cancer patients, breast cancer
patients, pelvic floor dysfunction patients, femoral head necrosis hip preservation
patients, lumbar disc herniation patients, Patients with chronic obstructive pulmonary
disease complicated with pulmonary heart disease in Chinese medicine, patients with
anatomical total shoulder replacement, patients with hip replacement, and knee replacement.
Pay attention to the health-related outcomes reported by patients, listen to the true
feelings of patients, provide patients with an understanding of their own health status,
adverse reactions that occur during treatment, the impact of physical functions and
the impact of different environments on personal and family life. Research hotspots
in the field of chronic diseases for several years.
Conclusions
With the continuous development and improvement of PROs, its high reliability and
simplicity of measurement have been recognized by more and more researchers and clinical
practitioners, but the current development and application in China is still in its
infancy and requires higher quality research to justified.
169-P. Evaluating multiple domains of health in high school athletes with sport-related
concussion
Richelle M. Williams1, Rachel S. Johnson,2; Alison R. Snyder Valier3,4,6; R. Curtis
Bay5, Tamara C. Valovich McLeod3,6
1Department of Athletic Training, Drake University, Des Moines, IA; 2Department of
Kinesiology, University of Georgia, Athens, GA; 3Athletic Training Programs, 4Department
of Research Support; 5Department of Interdisciplinary Health Sciences; 6 School of
Osteopathic Medicine in Arizona, A.T. Still University, Mesa, AZ
Correspondence: Richelle M. Williams (Richelle.williams@drake.edu)
Objective
The objective of this study was to evaluate patient-perceived health-related quality
of life (HRQOL) using the Patient-Reported Outcomes Measurement Information System
(PROMIS) Pediatric-25 subscale in adolescent patients throughout concussion recovery
and to describe the impact of sport-related concussion history on HRQOL.
Methods
This study included a convenience sample of male and female interscholastic students
from nine high school athletic training facilities who were participating in sports.
Patients who sustained isolated medically diagnosed concussions from sports participation
were administered the PROMIS Pediatric-25 scale at days 3 and 10 post-concussion and
at return-to-play (RTP). The following subscales were used for analysis: Physical
Function Mobility (PFM), Anxiety (ANX), Depression (DS), Fatigue (FTG), Pain Interference
(PI), and Peer Relationships (PR). Self-reported concussion history (yes/no) was collected.
Generalized estimating equations were used for primary PROMIS analysis (p<.05) and
summary statistics were reported as means and 95% CI. Ceiling and floor effects (more
than 15% of patients reporting the highest or lowest score on the subscale, respectively)
are reported.
Results
Seventy patients completed the study (51 males, 7 females, 12 unreported, age=15.7±0.9
years, height=174.6±8.4cm, mass=72.8±14.8 kg, grade=10.0±0.9 level). For the Pediatric-25
subscales, the severity of problems associated with PFM, ANX, DS, FTG, and PI were
highest 3 days post-concussion, decreasing at 10 days post and RTP (all P<.05). No
differences were found between days 3 and 10 for PR scores, but improvements were
identified at RTP (P<.05). Pediatric-25 subscale scores at the three measurements
were not statistically associated with concussion history (all P>.05). Ceiling and
floor effects were present in all subscales throughout each time point, except for
PFM (14.7%) and PI (11.8%) at day 3 post-injury.
Conclusions
Patients who suffered a concussion improved from day 3 through RTP on multiple health
domains including function, anxiety, depression, fatigue, and pain. Importantly, HRQOL
improved with time since injury; with between 41-79% of patients reaching the instruments’
best score by day 10 post-injury. Serial assessment of health domains is needed to
ensure recovery occurs, interventions are provided when deficits exist, and clinicians
can use that information to inform clinical decisions.
170-P. Psychometric proprieties of PROMIS Anxiety and Depression Short Forms among
breast cancer patients in China
Changrong Yuan, Qingmei Huang, Tingting Cai, Fulei Wu
All authors: School of Nursing, Fudan University, Shanghai 200032, China
Correspondence: Changrong Yuan (yuancr@fudan.edu.cn)
Objective
The patient-reported outcomes measurement information system (PROMIS) are developed
to assess patient-reported health outcomes for adults and children living with chronic
conditions. The adult PROMIS anxiety and depression short forms (SF) have been translated
into Chinese and applied in women with breast cancer in China. This study aimed to
evaluate the PROMIS anxiety and depression short forms 8a among patients with breast
cancer in China.
Methods
Internal reliability was evaluated using Cronbach’s alpha coefficient. Besides, scale
dimensionality was examined using confirmatory factor analysis (CFA). In addition,
concurrent validity was evaluated using correlations between PROMIS anxiety and depression
short forms and breast cancer quality of life scores (assessed by Functional Assessment
of Chronic Illness Treatment- Breast). Both classical (CTT) and modern (IRT) psychometric
methods were used to evaluate the items following the PROMIS validation scientific
standards. Known-groups validity was evaluated by comparing T-score differences among
patient groups regarding early cancer stage and later cancer stage. In addition, the
differential item functioning (DIF), item parameters and scale information curve were
analyzed.
Results
A final sample comprised 975 breast cancer patients. The Chinese version of PROMIS
anxiety-SF and depression-SF both demonstrated good internal consistency reliability.
Unidimensionality of the two measures were supported by CFA. The anxiety and depression
T-scores across patient group with later cancer stage were significantly higher than
those in the early group, which indicated good known-groups validity. According to
the IRT item parameters, the item discrimination parameters for anxiety-SF ranged
from 1.00-6.32, and the item threshold parameters ranged from - 1.39-2.38. As for
depression-SF, the item discrimination parameters and item threshold parameters ranged
from 1.00-8.63, and -1.39-2.60, respectively.
Conclusions
The Chinese version of adult PROMIS anxiety-SF and depression-SF showed satisfactory
psychometric proprieties among breast cancer patients. Additional research in a more
diverse sample is necessary to verify the results of this study.
171-P. Psychometric evaluation of PROMIS-Social Relationships Short Forms 4a among
patients with breast cancer in China
Tingting Cai, Changrong Yuan, Qingmei Huang, Fulei Wu
All authors: School of Nursing, Fudan University, 305 Fenglin Road, Shanghai 200032,
China
Correspondence: Changrong Yuan (yuancr@fudan.edu.cn)
Objective
In recent years, patient-reported outcomes measurement information system (PROMIS)
has expanded widely as recognition of their usefulness and effectiveness for routine
measurement of health and well-being in adults and children. The adult PROMIS Social
Relationships short forms 4a have been translated into Chinese based on standard translation
methodology. The aim of this study was to validate the Chinese version of the adult
PROMIS Social Relationships short 4a among breast cancer patients.
Methods
A cross–sectional research design was adopted using the Emotional Support, Informational
Support, and Instrumental Support subdomains, which were short forms of adult PROMIS
Social Relationships. Web-based and paper questionnaire administration was conducted
with a variety of Chinese respondent samples during 2018–2020. Analyses included Cronbach’s
alpha, confirmatory factor analysis (CFA), classical test theory (CTT) modeling, item
response theory (IRT) modeling and other psychometric methodologies.
Results
A total of 965 women with breast cancer in China was recruited and completed the investigations.
The Chinese version of adult PROMIS Social Relationships short forms 4a showed satisfactory
psychometric proprieties among the patients. Emotional Support, Informational Support,
and Instrumental Support showed good internal consistency reliability and validity
in this study. Unidimensionality and good known-groups validity of the short forms
were supported by the results. In addition, the IRT item parameters further demonstrated
the item discrimination parameters for Emotional Support ranged from 1.00-5.27, and
the item threshold parameters ranged from -1.76-1.39. With regard to Informational
Support, the item discrimination parameters and item threshold parameters ranged from
1.00-6.66, and -1.91-1.39, respectively. As for Instrumental Support, the data ranged
from 1.00-4.47, and -2.03-1.39 accordingly.
Conclusions
Adult PROMIS Social Relationships short forms 4a of Chinese version are demonstrated
to be feasible, valid, and reliable in breast cancer patients in China. Further research
in a more diverse sample and with different study design are encouraged to verify
the results in the current study.
172-P. Using cognitive interviewing to adapt PROMIS® Measure Items of Self-efficacy
for managing chronic conditions in Chinese cross-cultural translation
Dan Zhao1, Linning Yang2, Yan Jin3, Jiehui Xu3, Ting Zhang3, Xiuqun Yuan3, Danfeng
Zha3, Yan Yang1
1School of Nursing, Medical College, Soochow University, Suzhou, China; Renji Hospital
affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China; 2School
of Nursing, Shanghai Jiaotong University, Shanghai, China; 3Renji Hospital affiliated
to Shanghai Jiaotong University School of Medicine, Shanghai, China
Correspondence: Dan Zhao, (zd_2527@163.com)
Objective
To use cognitive interviewing techniques to evaluate the comprehension, wording and
format of PROMIS® Self- efficacy items among Chinese living with chronic conditions
after FACIT forward-backward translation and then to revise items based on subjects’
feedback.
Methods
We conducted 25 cognitive interviews of native Chinese speakers with diversity range
of chronic conditions (e.g., diabetes, hypertension, obesity, inflammatory bowel disease,
hepatic sclerosis, peptic ulcer, and cardiovascular disease) on 137 items of self-efficacy.
Retrospective probing was chosen due to the self-administered questionnaire. Audio
recordings were used to cover the gaps in the handwritten comments and were not transcribed
verbatim. Questionnaire Appraisal System (QAS-99) was used to code the text data.
A series of feedback from subjects were compiled. Then the experts and translation
group reviewed the data and decided whether to revise or rewrite each potential item.
Results
The appraisal from the cognitive interviews identified most items were easy understanding.
Meanwhile, some issues were encountered in the lengthy, awkward, syntax of the wording.
5 out of 25 emotions items, 8 out of 35 daily activities items, 6 out of 26 medicine
and treatment items, 2 out of 23 social interaction items and 4 out of 28 symptoms
items were found to have poor comprehension mainly for the reason of wording. And
7 of 137 items had to rewritten because of culturally inappropriate. All these items
were revised base on the subjects’ feedback, linguistic rules and the expert suggestions.
Conclusions
Cognitive interviewing is a useful method in conducting quality assessment of already
developed questionnaire and adapting items in the context of simplified Chinese. Results
showed that the revised version of PROMIS self-efficacy items is conceptually, culturally
and semantically equivalent to the original. Future work related to Chinese version
psychometric properties validation of PROMIS self-efficacy for managing chronic conditions
can now be initiated.
173-P. Development of a Pediatric PROMIS mini-program based on Wechat application
for children and adolescents
Wen Zhang, Qingmei Huang, Yueshi Huang, Changrong Yuan
All authors: School of Nursing, Fudan University, Shanghai, China
Correspondence: Changrong Yuan (yuancr@fudan.edu.cn)
Objective
This study was to develop a smartphone application Wechat-based mini-program to enable
children and adolescents aged 5-17 years old and their proxies to assess pediatric
patients’ quality of life-related symptoms and functions using Pediatric PROMIS profile-25.
Methods
A multidisciplinary team including researchers, clinical professionals and software
engineers was formed to discuss the contents, structures, and functions of the program
and its administrative portal, to make longitudinal assessment and data management
more efficient, and the interface more user-friendly. Several rounds of joint sessions
and modifications were performed among the team to assure the quality of the program
during the development.
Result
The Wechat mini-program ‘PROMIS Assessment’ for pediatric patients aged 8-17 years
old and proxies of all 5-17 year-old children was created. Pediatric PROMIS profile-25
involving seven dimensions (depressive symptoms, anxiety, fatigue, physical activity-mobility,
peer relationship, pain interference, and pain intensity) was used for QoL assessment.
Demographic information of both children and proxies and patients’ clinical information
were also included. Outcomes were shown with graphs to users in the ‘Disease Management’
and ‘Symptoms Management’ parts. Voice assistant, cartoon interface, and virtual animal
raise system were used to help increase children’s understanding and compliance.
Conclusion
The smartphone mini-program based on Wechat and its administration portal were developed
to assess and collect quality of life outcomes of pediatric patients using brief items.
It helps parents self-monitor their children’s disease progress and tendency of symptoms
and functions, as well as giving medical professionals patient-reported outcomes to
help make more targeted medical decisions.
174-P. The Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical
Function measures in adults – A systematic review of measurement properties
Valentijn J. Zonjee1, Inger L. Abma2, M.J. de Mooij1, Sander M. van Schaik1, Renske
M. Van den Berg-Vos1, Caroline B. Terwee3, Leo D. Roorda4
1OLVG Amsterdam, Department of Neurology, Amsterdam, The Netherlands; 2IQ healthcare,
Radboudumc, Nijmegen, The Netherlands; 3Amsterdam UMC, Vrije Universiteit Amsterdam,
Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute;
4Amsterdam Rehabilitation Research Center | Reade, Amsterdam, The Netherlands
Correspondence: Valentijn Zonjee (v.j.zonjee@olvg.nl)
Objective
This study aims to systematically review and critically appraise the measurement properties
of Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical Function
(PF) measures in adults.
Methods
MEDLINE and EMBASE were searched for studies on PROMIS-PF measurement properties.
Studies were included if the aim of the study was to evaluate at least one measurement
property of a PROMIS-PF measure in adults. No restrictions were made with respect
to language, study design and the type of application of the measure. Following the
COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)
methodology, Risk of bias was assessed using the COSMIN Risk of Bias checklist. The
results per measurement property were quantitatively or qualitatively pooled and the
quality of evidence was determined.
Results
The database searches identified 1086 unique studies. After title and abstract screening
by two independent reviewers, 284 studies were deemed eligible for full-text screening.
Conclusions
This study will systematically summarize, pool and appraise the measurement properties
of all PROMIS-PF measures that are currently available.