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Framing of research question using the PICOT format in randomised controlled trials of venous ulcer disease: a protocol for a systematic survey of the literature
  1. Luciana P F Abbade1,2,3,
  2. Mei Wang2,
  3. Kamath Sriganesh4,5,
  4. Lawrence Mbuagbaw2,3,
  5. Lehana Thabane2,3
  1. 1Department of Dermatology and Radiotherapy, Botucatu Medical School, Universidade Estadual Paulista, UNESP, São Paulo, Brazil
  2. 2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  3. 3Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, Ontario, Canada
  4. 4Department of Neuroanaesthesia, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India
  5. 5Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
  1. Correspondence to Dr Lehana Thabane; thabanl{at}


Introduction Although venous ulcers have a great social and economic impact, there is a lack of evidence from randomised controlled trials (RCTs) to support appropriate management for this disease. Framing the research question using the Population; Intervention; Comparator; Outcome; Time frame (PICOT) format in RCTs can improve the quality of the research design.

Objectives To evaluate how the PICOT format is used to frame a research question in reports of RCTs of venous ulcer disease and to determine the factors associated with better adherence to the PICOT format in framing the research question.

Methods and analyses We will conduct a systematic survey of RCTs on venous ulcers published in the National Institute of Health, PubMed database between January 2009 and May 2016. We will include all RCTs addressing therapeutic intervention for venous ulcer disease involving human subjects, and published in the English language. The selection process will be carried out in duplicate by two independent investigators. First, titles and abstracts will be screened, then full-text articles. We will examine whether the five elements of the PICOT format are used in formulating the research question and give a score between 0 and 5. The primary outcome will be the proportion of studies that have adequately reported all five PICOT elements.

Dissemination This will be the first survey to assess how the PICOT format is used to frame research questions on the management of venous ulcers in reports of RCTs. On completion, this review will be submitted to a peer-reviewed biomedical journal for publication and the findings will also be presented at scientific conferences.

  • Venous ulcers
  • Randomized controlled trial

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  • Contributors LPFA was involved in the search strategy, design, testing of the data extraction form and writing of the initial draft. LT was responsible for the conception, design of the review and critical review of the final draft. KS and MW were involved in the design and testing of the data extraction form. LM contributed to improvements in the manuscript and critically revised the final draft. All authors contributed to the protocol and approved the final manuscript.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.