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      The range and suitability of outcome measures used in the assessment of palliative treatment for inoperable malignant bowel obstruction: A systematic review

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          Abstract

          Background:

          Malignant bowel obstruction, a complication of certain advanced cancers, causes severe symptoms which profoundly affect quality of life. Clinical management remains complex, and outcome assessment is inconsistent.

          Aim:

          To identify outcomes evaluating palliative treatment for inoperable malignant bowel obstruction, as part of a four-phase study developing a core outcome set.

          Design:

          The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA); PROSPERO (ID: CRD42019150648). Eligible studies included at least one subgroup with obstruction below the ligament of Treitz undergoing palliative treatment for inoperable malignant bowel obstruction. Study quality was not assessed because the review does not evaluate efficacy.

          Data sources:

          Medline, Embase, the Cochrane Database, CINAHL, PSYCinfo Caresearch, Open Grey and BASE were searched for trials and observational studies in October 2021.

          Results:

          A total of 4769 studies were screened, 290 full texts retrieved and 80 (13,898 participants) included in a narrative synthesis; 343 outcomes were extracted verbatim and pooled into 90 unique terms across six domains: physiological, nutrition, life impact, resource use, mortality and survival. Prevalent outcomes included adverse events (78% of studies), survival (54%), symptom control (39%) and mortality (31%). Key individual symptoms assessed were vomiting (41% of studies), nausea (34%) and pain (33%); 19% of studies assessed quality of life.

          Conclusions:

          Assessment focuses on survival, complications and overall symptom control. There is a need for definitions of treatment ‘success’ that are meaningful to patients, a more consistent approach to symptom assessment, and greater consideration of how to measure wellbeing in this population.

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          Most cited references112

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          The COMET Handbook: version 1.0

          The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users.
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            A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery

            Objectives There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. Study Design and Setting A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Results Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. Conclusions This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.
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              A brief, patient- and proxy-reported outcome measure in advanced illness: Validity, reliability and responsiveness of the Integrated Palliative care Outcome Scale (IPOS)

              Background: Few measures capture the complex symptoms and concerns of those receiving palliative care. Aim: To validate the Integrated Palliative care Outcome Scale, a measure underpinned by extensive psychometric development, by evaluating its validity, reliability and responsiveness to change. Design: Concurrent, cross-cultural validation study of the Integrated Palliative care Outcome Scale – both (1) patient self-report and (2) staff proxy-report versions. We tested construct validity (factor analysis, known-group comparisons, and correlational analysis), reliability (internal consistency, agreement, and test–retest reliability), and responsiveness (through longitudinal evaluation of change). Setting/participants: In all, 376 adults receiving palliative care, and 161 clinicians, from a range of settings in the United Kingdom and Germany Results: We confirm a three-factor structure (Physical Symptoms, Emotional Symptoms and Communication/Practical Issues). Integrated Palliative care Outcome Scale shows strong ability to distinguish between clinically relevant groups; total Integrated Palliative care Outcome Scale and Integrated Palliative care Outcome Scale subscale scores were higher – reflecting more problems – in those patients with ‘unstable’ or ‘deteriorating’ versus ‘stable’ Phase of Illness (F = 15.1, p   0.60). Longitudinal validity in form of responsiveness to change is good. Conclusion: The Integrated Palliative care Outcome Scale is a valid and reliable outcome measure, both in patient self-report and staff proxy-report versions. It can assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care. This represents a major step forward internationally for palliative care outcome measurement.
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                Author and article information

                Journal
                Palliat Med
                Palliat Med
                PMJ
                sppmj
                Palliative Medicine
                SAGE Publications (Sage UK: London, England )
                0269-2163
                1477-030X
                21 September 2022
                October 2022
                : 36
                : 9
                : 1336-1350
                Affiliations
                [1 ]Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Kingston upon Hull, UK
                [2 ]Dove House Hospice, Kingston upon Hull, UK
                [3 ]Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, UK
                [4 ]University of Technology Sydney, Sydney, NSW, Australia
                [5 ]Queen’s Centre for Oncology and Haematology, Cottingham, Hull, UK
                [6 ]National Cancer Research Institute, Consumer Liaison Group, Trans-Humber Consumer Research Panel, London, UK
                Author notes
                [*]Alison Bravington, Hull York Medical School, University of Hull, Cottingham Road, Kingston upon Hull HU6 7RX, UK. Email: alison.bravington@ 123456hyms.ac.uk
                Author information
                https://orcid.org/0000-0002-0680-2093
                https://orcid.org/0000-0002-7571-4820
                https://orcid.org/0000-0001-6204-9158
                https://orcid.org/0000-0003-1289-3726
                https://orcid.org/0000-0001-5272-3057
                Article
                10.1177_02692163221122352
                10.1177/02692163221122352
                10150264
                36131489
                6e206ce2-b287-4ef7-86d0-690e1f875622
                © The Author(s) 2022

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                Funding
                Funded by: Marie Curie, FundRef https://doi.org/10.13039/501100000654;
                Award ID: MCRGS-20171220-802
                Categories
                Original Articles
                Custom metadata
                ts1

                Anesthesiology & Pain management
                intestinal obstruction,malignant bowel obstruction,outcome assessment,palliative care,quality of life,systematic review,terminal care

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