Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey

Abstract

Background The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. Objective This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting. Methods The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined. Results The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p < 0.001) were associated with a significantly higher number of CONSORT pilot items reported. Conclusions Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials. Electronic supplementary material The online version of this article (10.1186/s40814-019-0436-3) contains supplementary material, which is available to authorized users.

Are some feasibility studies more feasible than others? A review of the outcomes of feasibility studies on the ISRCTN registry

“…Third, the bar to demonstrate feasibility may be artificially low if studies are not identifying and addressing the specific challenges in the clinical field of interest. This may be accentuated if feasibility studies rely on a formulaic design [ 8 ]. Fourth, the team may be reluctant to publish the conclusion that a trial is not feasible.…”

“…Perhaps the view that feasibility studies are essential before conducting a RCT is leading to the design of studies which are likely to ‘succeed’ and therefore lack equipoise or do not focus on the most important uncertainties which need to be addressed in relation to the specific trial. As shown by the existing literature, it is often the case that feasibility studies in certain topic areas do not maximise their potential benefit and focus on the key uncertainties [ 8 , 11 ] and instead adopt a generic design.…”

“…Whilst these contributions [4][5][6][7] take an overarching perspective on the design and conduct of feasibility studies, a recent trend has focussed on their role and effectiveness in specific disciplines or in particular trial designs. Kosa et al found that pilot studies in chronic kidney disease patients on haemodialysis did not typically adhere to CONSORT reporting guidelines; however, improvements were noted in the reports of larger and more recent studies [8]. Fairhurst et al concluded that pilot and feasibility studies conducted in surgery fail to fully address the uncertainties specifically related to surgical RCTs and instead focus on generic uncertainties [9].…”

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol

“…Pilot and feasibility randomised trials in surgery will be poorly reported as per the CONSORT extension for pilot trials. We predict that the majority of included studies will report less than half of the items included in the CONSORT extension to randomised pilot and feasibility trials (ie, >50% of pilot randomised controlled trials (RCTs) will report <50% of the CONSORT items) 19 20 24…”

“…It is a 40-item checklist that applies to any randomised trial in which a future definitive randomised trial, or some component of it, is scaled down to assess the feasibility of the future randomised trial, regardless of the design (eg, factorial and cluster) 17. Previous methodological reviews have evaluated pilot randomised trials as per the CONSORT extension to randomised pilot and feasibility trials in chronic kidney disease and psychiatric illness; however, a review of this nature has yet to be conducted with surgical pilot randomised trials 19 20. Two additional important concepts of reporting quality include spin reporting and consistency between abstract and full-text reporting.…”