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      The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial

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          Abstract

          Objective

          To evaluate the effectiveness of a structured education pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD).

          Design

          Two-arm, cluster randomised controlled trial.

          Setting

          32 general practices in the Republic of Ireland.

          Participants

          350 participants with a diagnosis of moderate or severe COPD.

          Intervention

          Experimental group received a structured education pulmonary rehabilitation programme, delivered by the practice nurse and physiotherapist. Control group received usual care.

          Main outcome measure

          Health status as measured by the Chronic Respiratory Questionnaire (CRQ) at baseline and at 12–14 weeks postcompletion of the programme.

          Results

          Participants allocated to the intervention group had statistically significant higher mean change total CRQ scores (adjusted mean difference (MD) 1.11, 95% CI 0.35 to 1.87). However, the CI does not exclude a smaller difference than the one that was prespecified as clinically important. Participants allocated to the intervention group also had statistically significant higher mean CRQ Dyspnoea scores after intervention (adjusted MD 0.49, 95% CI 0.20 to 0.78) and CRQ Physical scores (adjusted MD 0.37, 95% CI 0.14 to 0.60). However, CIs for both the CRQ Dyspnoea and CRQ Physical subscales do not exclude smaller differences as prespecified as clinically important. No other statistically significant differences between groups were seen.

          Conclusions

          A primary care based structured education pulmonary rehabilitation programme is feasible and may increase local accessibility to people with moderate and severe COPD.

          Trial registration

          ISRCTN52403063.

          Related collections

          Most cited references19

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation.

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              Effect of a self-management program on patients with chronic disease.

              For patients with chronic disease, there is growing interest in "self-management" programs that emphasize the patients' central role in managing their illness. A recent randomized clinical trial demonstrated the potential of self-management to improve health status and reduce health care utilization in patients with chronic diseases. To evaluate outcomes of a chronic disease self-management program in a real-world" setting. Before-after cohort study. Of the 613 patients from various Kaiser Permanente hospitals and clinics recruited for the study, 489 had complete baseline and follow-up data. The Chronic Disease Self-Management Program is a 7-week, small-group intervention attended by people with different chronic conditions. It is taught largely by peer instructors from a highly structured manual. The program is based on self-efficacy theory and emphasizes problem solving, decision making, and confidence building. Health behavior, self-efficacy (confidence in ability to deal with health problems), health status, and health care utilization, assessed at baseline and at 12 months by self-administered questionnaires. At 1 year, participants in the program experienced statistically significant improvements in health behaviors (exercise, cognitive symptom management, and communication with physicians), self-efficacy, and health status (fatigue, shortness of breath, pain, role function, depression, and health distress) and had fewer visits to the emergency department (ED) (0.4 visits in the 6 months prior to baseline, compared with 0.3 in the 6 months prior to follow-up; P = 0.05). There were slightly fewer outpatient visits to physicians and fewer days in hospital, but the differences were not statistically significant. Results were of about the same magnitude as those observed in a previous randomized, controlled trial. Program costs were estimated to be about $200 per participant. We replicated the results of our previous clinical trial of a chronic disease self-management program in a "real-world" setting. One year after exposure to the program, most patients experienced statistically significant improvements in a variety of health outcomes and had fewer ED visits.
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                Author and article information

                Journal
                Thorax
                Thorax
                thoraxjnl
                thorax
                Thorax
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0040-6376
                1468-3296
                October 2013
                4 June 2013
                : 68
                : 10
                : 922-928
                Affiliations
                [1 ]School of Nursing and Midwifery, National University of Ireland , Galway, Ireland
                [2 ]HRB Clinical Research Facility and School of Mathematics, Statistics and Applied Mathematics, National University of Ireland , Galway, Ireland
                [3 ]School of Business & Economics, National University of Ireland , Galway, Ireland
                [4 ]Statistics Mathematic and Statistics Department, University of Canterbury , Christchurch, New Zealand
                [5 ]Department of General Practice, National University of Ireland , Galway, Ireland
                Author notes
                [Correspondence to ] Dr Dympna Casey, School of Nursing & Midwifery, National University of Ireland, Galway, Ireland; dympna.casey@ 123456nuigalway.ie
                Article
                thoraxjnl-2012-203103
                10.1136/thoraxjnl-2012-203103
                3786654
                23736156
                3d93d39b-cc0c-4f36-b23f-0b93da87d093
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

                History
                : 11 December 2012
                : 4 April 2013
                : 11 April 2013
                Categories
                1506
                Chronic Obstructive Pulmonary Disease
                Original article
                Custom metadata
                unlocked

                Surgery
                pulmonary rehabilitation,exercise
                Surgery
                pulmonary rehabilitation, exercise

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