Variation in outcome reporting in studies of fertility‐sparing surgery for cervical cancer: A systematic review

Abstract

Background: Cervical cancer affects 3197 women in the UK, and 604 000 women worldwide annually, with peak incidence seen in women between 30 and 34 years of age. For many, fertility-sparing surgery is an appealing option where possible. However, absence of large-scale data, along with a notable variation in reported outcomes in relevant studies, may undermine future efforts for consistent evidence synthesis. Objectives: To systematically review the reported outcomes measured in studies that include women who underwent fertility-sparing surgery for cervical cancer and identify whether variation exists. Search strategy: We searched MEDLINE, EMBASE and CENTRAL from inception to February 2019. Selection criteria: Randomised controlled trials, cohort and observational studies, and case studies of more than ten participants from January 1990 to date. Data collection and analysis: Study characteristics and all reported treatment outcomes. Main results: A total of 104 studies with a sum of 9535 participants were identified. Most studies reported on oncological outcomes (97/104), followed by fertility and pregnancy (86/104), postoperative complications (74/104), intra-operative complications (72/104) and quality of life (5/104). There was huge variation and heterogeneity in reported outcomes, with only 12% being good quality and 87% being of poor quality. Conclusions: There is significant heterogeneity in the reported outcomes. An agreed Core Outcome Set is necessary for future studies to effectively harmonise reported outcomes that are measurable and relevant to patients, clinicians and researchers. This systematic review sets the groundwork for the development of a Core Outcome Set for fertility-sparing surgery in cervical cancer.

Five aspects of research waste in biomedicine: A scoping review

“…Other flaws in the study design were variations in outcome measures across trials within the same subject 23 and the absence of essential data on trial outcomes 24,25 . Variations in outcome measures makes comparing results and conducting meta‐analysis difficult, which can obscure potential associations that individual studies cannot discover 26 . Reports, therefore, advocated using core outcome sets 27,28 .…”

“…This refers to an intentional choice regarding which results or findings are disclosed and withheld. This process can have significant implications and consequences, as it can shape the perception and understanding of an issue, influence decision‐making, and impact the credibility and accountability of those involved 26,63 . Some reports argue that choosing not to publish a protocol is also a part of the problem 64,65 .…”

“…24,25 Variations in outcome measures makes comparing results and conducting meta-analysis difficult, which can obscure potential associations that individual studies cannot discover. 26 Reports, therefore, advocated using core outcome sets. 27,28 When planning a study, the statistical power to prove an association is essential since inadequate or absent sample size planning can lead to sample sizes that are, at best, inefficient and, at worst, ethically questionable.…”

“…This process can have significant implications and consequences, as it can shape the perception and understanding of an issue, influence decision-making, and impact the credibility and accountability of those involved. 26,63 Some reports argue that choosing not to publish a protocol is also a part of the problem. 64,65 Publishing a protocol is not formally required by journals, but it is regarded as favor-able to avoid duplicate efforts and methodological flaws by selective reporting.…”