The framing of research questions using the PICOT format in randomized controlled trials of venous ulcer disease is suboptimal: A systematic survey

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.

Mapping the nomenclature, methodology, and reporting of studies that review methods: a pilot methodological review

“…There were 236 articles retrieved from the PubMed search of which 31 were included in the final quantitative and qualitative analysis (see Fig. 1 for study flow diagram with reasons for exclusion) [ 27 – 57 ]. There was moderate inter-rater agreement between reviewers before consensus ( κ = 0.78; 95% CI 0.73–0.82).…”

“…Based on the previously defined criteria, we scored ten studies (32.3%) as generalizable [28,30,38,40,49,[51][52][53][54]57]. Only three studies (9.7%, two of which we scored as generalizable) commented on generalizability and reported their own work as generalizable, either to the subject area (e.g., venous ulcer disease), to a clinical area, or in general terms [27,30,38].…”

“…Five studies (16.1%) performed an a priori sample size calculation of records to be included, using a variety of methods. Abbade et al used an estimate for the primary objective from a prior similar study [27], and similarly, Riado Minguez et al used a prior similar study to determine a target sample size coupled with a power calculation [43]. El Dib et al sampled enough studies to achieve a CI of ± 0.10 around all proportions [33], and Zhang et al used a precise CI of ± 0.05 [57].…”

A tutorial on methodological studies: the what, when, how and why

“…Any study that describes or analyzes methods (design, conduct, analysis or reporting) in published (or unpublished) literature is a methodological study. Consequently, the scope of methodological studies is quite extensive and includes, but is not limited to, topics as diverse as: research question formulation [11]; adherence to reporting guidelines [12][13][14] and consistency in reporting [15]; approaches to study analysis [16];…”

“…Methodological studies can also be used to determine the factors associated with reporting practices. For example, Abbade et al investigated journal characteristics associated with the use of the Participants, Intervention, Comparison, Outcome, Timeframe (PICOT) format in framing research questions in trials of venous ulcer disease [11].…”