title: Excellent adherence and no contamination by physiotherapists involved in a randomized controlled trial on reactivation of COPD patients: a qualitative process evaluation study.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The adherence of physiotherapists with the COPE-active protocol was high, remained unchanged over time, and no obvious contamination bias occurred.
authors: Department of Respiratory Medicine, Repatriation General Hospital, Daw Park, The Netherlands.
authors: Tanja W
authors: TW
authors: Effing
authors: Manon
authors: M
authors: Krabbenbos
authors: Marcel E
authors: ME
authors: Pieterse
authors: Paul D L P M
authors: PD
authors: van der Valk
authors: Gerhard A
authors: GA
authors: Zielhuis
authors: Huib A M
authors: HA
authors: Kerstjens
authors: Job
authors: J
authors: van der Palen
mesh_terms: D015982:Bias; D002985:Clinical Protocols; D019983:Guideline Adherence; D006801:Humans; D059825:Physical Therapists; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology* / Q000534:rehabilitation