title: Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design.
abstract: BACKGROUND
  Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters.
  
  
  METHODS
  We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design.
  
  
  CONCLUSIONS
  The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process.
  
  
  CONCLUSIONS
  Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial.
  
  
  BACKGROUND
  Health Eating and Active Living with Diabetes: ClinicalTrials.gov identifier: NCT00991380. Date registered: 7 October 2009. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Clintrials.gov Identifier: NCT01328639 Date registered: 30 March 2011.
authors: Alliance for Canadian Health Outcomes Research in Diabetes, School of Public Health, University of Alberta, 2-040 Li Ka Shing Center for Health Research Innovation, Edmonton, AB, T6G 2E1, Canada. nonsi.mathe@ualberta.ca.|Center for Nursing and Health Studies, Faculty of Health Disciplines, Athabasca University, Athabasca, AB, Canada. nonsi.mathe@ualberta.ca.
authors: Nonsikelelo
authors: N
authors: Mathe
authors: Alliance for Canadian Health Outcomes Research in Diabetes, School of Public Health, University of Alberta, 2-040 Li Ka Shing Center for Health Research Innovation, Edmonton, AB, T6G 2E1, Canada. sjohnson@athabascau.ca.|Center for Nursing and Health Studies, Faculty of Health Disciplines, Athabasca University, Athabasca, AB, Canada. sjohnson@athabascau.ca.
authors: Steven T
authors: ST
authors: Johnson
authors: Alliance for Canadian Health Outcomes Research in Diabetes, School of Public Health, University of Alberta, 2-040 Li Ka Shing Center for Health Research Innovation, Edmonton, AB, T6G 2E1, Canada. lwozniak@ualberta.ca.
authors: Lisa A
authors: LA
authors: Wozniak
authors: Alberta Diabetes Institute, Edmonton, AB, Canada. me2.majumdar@ualberta.ca.|Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada. me2.majumdar@ualberta.ca.
authors: Sumit R
authors: SR
authors: Majumdar
authors: Alliance for Canadian Health Outcomes Research in Diabetes, School of Public Health, University of Alberta, 2-040 Li Ka Shing Center for Health Research Innovation, Edmonton, AB, T6G 2E1, Canada. jeff.johnson@ualberta.ca.
authors: Jeffrey A
authors: JA
authors: Johnson
mesh_terms: D000368:Aged; D000416:Alberta / Q000453:epidemiology; D001291:Attitude of Health Personnel; D016265:Conflict of Interest; D003863:Depression / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D003927:Diet, Diabetic; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D018579:Patient Selection / Q000941:ethics; D011320:Primary Health Care / Q000941:ethics / Q000592:standards*; D011569:Psychiatric Status Rating Scales; D058996:Quality Improvement / Q000941:ethics / Q000592:standards*; D019984:Quality Indicators, Health Care / Q000941:ethics / Q000592:standards*; D012108:Research Personnel / Q000523:psychology; D040242:Risk Reduction Behavior; D011795:Surveys and Questionnaires; D016896:Treatment Outcome