Systematic review of reporting benefits and harms of surgical interventions in randomized clinical trials

Abstract

Background Standardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision‐making. Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before asking informed consent. Methods RCTs published between January 2005 and January 2017 in 15 leading journals comparing a surgical treatment with any other treatment were reviewed systematically. The CONSORT checklist, including the extension for harms, was used to appraise the publications. Beneficial and harmful treatment outcomes, their definitions and their precision measures were extracted. Results Of 1200 RCTs screened, 88 trials were included. For the differences in effect size of beneficial outcomes, 68 per cent of the trials reported a P value only but not a 95 per cent confidence interval. For harmful effects, this was 67 per cent. Only five of the 88 trials (6 per cent) reported a number needed to treat, and no study a number needed to harm. Only 61 per cent of the trials reported on both the beneficial and harmful outcomes of the intervention studied in the same paper. Conclusion Despite CONSORT guidelines, current reporting of benefits and harms in surgical trials does not facilitate clear communication of treatment outcomes with patients. Researchers, reviewers and journal editors should ensure proper reporting of treatment benefits and harms in trials.

Abstracts Reporting of Randomized Controlled Trials in Ten Highest-ranking Nursing Journals: Improvement in the Quality Since CONSORT Extension for Abstracts

“…According to CONSORT -A, advent events is an important piece of information for the reader and should be reported in abstracts (Stubenrouch et al, 2020). Our study found no abstracts report this information.…”

“…Overall, however, less than a quarter of the included abstracts adequately reported randomization methods. Reporting deficiencies in these items are also found in other areas (Seta et al, 2020;Stubenrouch et al, 2020). Since a lack of description of important methodological items could cause bias and affects the reliability and validity of RCT abstracts (Seta et al, 2020), we encourage trialists and journal editors to work towards solutions to mitigate these issue.…”

A mapping review of sacrococcygeal pilonidal sinus disease

“…Systematic reviews also called for RCTs addressing the use of methylene blue. There were also gaps in data exploring laser depilation to prevent recurrence [ 20 , 21 ]. There was a clear need for further data exploring the roles of wound care adjuncts in the aftercare setting [ 22 , 23 ].…”

“…Systematic reviews call for: trials on laser hair depilation to prevent recurrence [ 20 , 21 ]…”

Availability and use of number needed to treat (NNT) based decision aids for pharmaceutical interventions

“…A potential barrier may stem from the general dearth of high-quality reporting of RCT data to facilitate clear communication of treatment outcomes with patients. 84 Despite the availability of guidelines such as the CONSORT statement, a review of a sample of RCTs published within the past two decades in leading surgical and medical journals found only 5 of 88 articles mentioned an NNT or NNH. However, an NNT/NNH could have been calculated based on the absolute figures given for 8 out of 46 reported primary outcomes (NNT) and 2 of the 63 documented primary adverse outcomes (NNH).…”