ABSTRACT
Despite several publications on venous ulcers, there is still a lack of evidence from randomized controlled trials (RCTs) to support certain treatments for patients with this disorder. Well-designed research questions using the PICOT (Population; Intervention; Comparator; Outcome; Time-frame) format in RCTs can improve the quality of research. The objectives of this study were to assess how the PICOT format is used to frame research questions in RCTs published on venous ulcer disease and to determine the factors associated with better adherence to the PICOT format. We conducted a systematic survey of RCTs on venous ulcers published in the PubMed database between January 2009 and May 2016. All RCTs published in English addressing therapeutic interventions for venous ulcer disease in human subjects were included. We examined whether the five elements of the PICOT format were used in formulating the research question and scored them between 0 and 5. The primary outcome of this systematic survey was the percentage of studies that adequately reported all five PICOT elements. Eighty-five (85) RCTs were included with median PICOT score of 3 (IQR = 1.5). Four elements of PICOT were present in 28 reports (32.9%) and only 2 RCTS (2.3%) reported all the PICOT elements. Population and intervention were often appropriately described, in (70/85) 82.4% and (83/85) 97.6% of the studies, respectively; however, comparison intervention and outcome were presented in only (53/85) 62.3% and (48/85) 56.5% of studies, respectively. Very few RCTs (7.1%; 6/85) reported the study time frame. No journal or RCT characteristics were found to be significantly associated with better reporting. Use of the PICOT format to frame research questions in RCTs published on venous ulcers is suboptimal, and our study reinforces the importance of framing a good research question to improve the design of trials and quality of evidence in venous ulcer disease.
Subject(s)
Population Surveillance/methods , Randomized Controlled Trials as Topic , Varicose Ulcer/therapy , Wound Healing , HumansABSTRACT
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.