Developing evidence-based plastic surgery: the role of research registration, protocols and reporting quality

BACKGROUND: Evidence-based medicine has had a profound impact on healthcare. In the field of Plastic surgery, powerful examples include; less radical skin cancer excision margins and skin-sparing or even nipple-sparing mastectomies and microsurgical reconstruction. Sustained progression of the field, relies on the development of a high-quality evidence base, with strong use of peer-reviewed research protocols, which are publicly registered and completed studies transparently reported. The extent of compliance with these principles is currently unknown and the author hypothesised that it would be low. The author further hypothesised that registration could be improved by the development of a new global research registry and reporting quality can be improved by the mandatory implementation of reporting guidelines in a journal.
METHODS: This thesis incorporated 11 studies. The first two studies used a literature review to determine; the levels of evidence, rates of study registration and protocol publication in the recent Plastic Surgery literature. Thirdly, the design, build and launch of a new global research registry to boost compliance with registration and to determine barriers to it using a survey amongst users. This would be followed by systematic reviews to determine compliance with the STROBE and PRISMA guidelines respectively. An analysis of each guide for authors (GFA) of the surgical journals listed in the Thomson Reuters journal citation report for surgery to determine support for reporting guidelines. The impact of the mandatory implementation of reporting guidelines in a surgical journal would be assessed using a before and after design. Finally, to develop a reporting guideline for surgical case reports (SCARE) and surgical case series (PROCESS) using a DELPHI consensus exercise amongst an expert panel.
RESULTS: Protocols were registered in 4% of 595 recent research studies and 0.5% were published. There was a mean compliance of 12/22 for the STROBE guideline (n=94) and 16/27 for the PRISMA guideline (n=79). The Research Registry® was launched in February 2015. Analysis of the first 500 previously unregistered studies, showed they came from 57 countries and included 1.77 million patients. Key barriers to registration were a lack of awareness of the need to register and lack of time (n=149). In addition, 45% registered their study at the time of journal submission. The GFA analysis showed 62% didn’t mention reporting guidelines at all (n=193). Subsequent mandatory implementation in a single surgical journal, increased compliance with STROBE by 12% (n=152), with CONSORT by 40% (n=13) and with PRISMA by 58% (n=28). The SCARE and PROCESS reporting guidelines were developed and published in late 2016. According to Google Scholar, they have accumulated over 200 citations at the time of writing.
CONCLUSION: Study registration, protocol use and reporting quality are poor in plastic surgery. Potential solutions to these long-standing problems have been developed and explored within this thesis. These include the development and use of the Research Registry® and the mandatory implementation of reporting guidelines, with both measures front-loaded within a gatekeeper framework for journals. It is now for Plastic Surgeons and the wider surgical community to pick up the gauntlet and drive forward high-quality research, evidence-based surgical practice and better outcomes for their patients and society at large.

Keywords: Protocols
Research registration
Surgery
Plastic Surgery
Scientific journals
Reporting quality
Plastic Surgeons
Evidence based medicine
Advisor: McCulloch, P
Orgill, D