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      Excellent adherence and no contamination by physiotherapists involved in a randomized controlled trial on reactivation of COPD patients: a qualitative process evaluation study

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          To assess the adherence of physiotherapists to the study protocol and the occurrence of contamination bias during the course of a randomized controlled trial with a recruitment period of 2 years and a 1-year follow-up (COPE-II study).

          Study design and setting

          In the COPE-II study, intervention patients received a standardized physiotherapeutic reactivation intervention (COPE-active) and control patients received usual care. The latter could include regular physiotherapy treatment. Information about the adherence of physiotherapists with the study protocol was collected by performing a single interview with both intervention and control patients. Patients were only interviewed when they were currently receiving physiotherapy. Interviews were performed during two separate time periods, 10 months apart. Nine characteristics of the COPE-active intervention were scored. Scores were converted into percentages (0%, no aspects of COPE-active; 100%, full implementation of COPE-active).


          Fifty-one patients were interviewed (first period: intervention n = 14 and control n = 10; second period: intervention n = 18 and control n = 9). Adherence with the COPE-active protocol was high (median scores: period 1, 96.8%; period 2, 92.1%), and large contrasts in scores between the intervention and control group were found (period 1: 96.8% versus 22.7%; period 2: 92.1% versus 25.0%). The scores of patients treated by seven physiotherapists who trained patients of both study groups were similar to the scores of patients treated by physiotherapists who only trained patients of one study group.


          The adherence of physiotherapists with the COPE-active protocol was high, remained unchanged over time, and no obvious contamination bias occurred.

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          Most cited references 17

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          American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation.

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            Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention.

            Self-management interventions improve various outcomes for many chronic diseases. The definite place of self-management in the care of chronic obstructive pulmonary disease (COPD) has not been established. We evaluated the effect of a continuum of self-management, specific to COPD, on the use of hospital services and health status among patients with moderate to severe disease. A multicenter, randomized clinical trial was carried out in 7 hospitals from February 1998 to July 1999. All patients had advanced COPD with at least 1 hospitalization for exacerbation in the previous year. Patients were assigned to a self-management program or to usual care. The intervention consisted of a comprehensive patient education program administered through weekly visits by trained health professionals over a 2-month period with monthly telephone follow-up. Over 12 months, data were collected regarding the primary outcome and number of hospitalizations; secondary outcomes included emergency visits and patient health status. Hospital admissions for exacerbation of COPD were reduced by 39.8% in the intervention group compared with the usual care group (P =.01), and admissions for other health problems were reduced by 57.1% (P =.01). Emergency department visits were reduced by 41.0% (P =.02) and unscheduled physician visits by 58.9% (P =.003). Greater improvements in the impact subscale and total quality-of-life scores were observed in the intervention group at 4 months, although some of the benefits were maintained only for the impact score at 12 months. A continuum of self-management for COPD patients provided by a trained health professional can significantly reduce the utilization of health care services and improve health status. This approach of care can be implemented within normal practice.
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              Evidence of self-report bias in assessing adherence to guidelines.

              To assess trends in the use of self-report measures in research on adherence to practice guidelines since 1980, and to determine the impact of response bias on the validity of self-reports as measures of quality of care. We conducted a MEDLINE search using defined search terms for the period 1980 to 1996. Included studies evaluated the adherence of clinicians to practice guidelines, official policies, or other evidence-based recommendations. Among studies containing both self-report (e.g. interviews) and objective measures of adherence (e.g. medical records), we compared self-reported and objective adherence rates (measured as per cent adherence). Evidence of response bias was defined as self-reported adherence significantly exceeding the objective measure at the 5% level. We identified 326 studies of guideline adherence. The use of self-report measures of adherence increased from 18% of studies in 1980 to 41% of studies in 1985. Of the 10 studies that used both self-report and objective measures, eight supported the existence of response bias in all self-reported measures. In 87% of 37 comparisons, self-reported adherence rates exceeded the objective rates, resulting in a median over-estimation of adherence of 27% (absolute difference). Although self-reports may provide information regarding clinicians' knowledge of guideline recommendations, they are subject to bias and should not be used as the sole measure of guideline adherence.

                Author and article information

                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                25 May 2012
                : 7
                : 337-344
                [1 ]Repatriation General Hospital, Department of Respiratory Medicine, Daw Park
                [2 ]Flinders University, School of Medicine, Adelaide, South Australia, Australia
                [3 ]Medisch Spectrum Twente, Department of Pulmonology, Enschede
                [4 ]Department of Psychology, Health and Technology, Enschede
                [5 ]Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen, Nijmegen
                [6 ]Department of Pulmonology, University Medical Center Groningen, University of Groningen, Groningen
                [7 ]Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands
                Author notes
                Correspondence: Tanja Effing, Repatriation General Hospital, Department of Respiratory Medicine, Daws Road, Daw Park SA 5041, Australia, Tel +61 882 751 189, Fax +61 882 751 195, Email tanja.effing@
                © 2012 Effing et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Original Research


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