The STROCSS 2024 guideline: strengthening the reporting of cohort, cross-sectional and case-control studies in surgery.

INTRODUCTION: First released in 2017, the STROCSS guidelines have become integral for promoting high-quality reporting of observational research in surgery. However, regular updates are essential to ensure they remain relevant and of value to surgeons. Building on the 2021 updates, we have developed the STROCSS 2024 guidelines. This timely revision aims to address residual reporting gaps, assimilate recent advances, and further strengthen observational study quality across all surgical disciplines. METHODS: A core steering committee compiled proposed changes to update the STROCSS 2021 guidelines based on identified gaps in prior iterations. An expert panel of surgical research leaders then evaluated the proposed changes for inclusion. A Delphi consensus exercise was used. Proposals that scored between 7-9 on a nine-point Likert agreement scale, by ≥70% of Delphi participants, were integrated into the STROCSS 2024 checklist. RESULTS: In total, 46 of 56 invited participants (82%) completed the Delphi survey and hence participated in the development of STROCSS 2024. All suggested amendments met the criteria for inclusion, indicating a high level of agreement among the Delphi group. All proposed items were therefore integrated into the final revised checklist. CONCLUSION: We present the updated STROCSS 2024 guidelines, which have been developed through expert consensus to further enhance the transparency and reporting quality of observational research in surgery.

The SCARE 2023 guideline: updating consensus Surgical CAse REport (SCARE) guidelines.

BACKGROUND: The Surgical CAse REport (SCARE) guidelines were first published in 2016 as a tool for surgeons to document and report their surgical cases in a standardised and comprehensive manner. However, with advances in technology and changes in the healthcare landscape, it is important to revise and update these guidelines to ensure they remain relevant and valuable for surgeons. MATERIALS AND METHODS: The updated guidelines were produced through a Delphi consensus exercise. Members of the SCARE 2020 guidelines Delphi group, editorial board members, and peer reviewers were invited to participate. Potential contributors were contacted by e-mail. An online survey was completed to indicate their agreement with the proposed changes to the guideline items. RESULTS: A total of 54 participants were invited to participate and 44 (81.5%) completed the survey. There was a high degree of agreement among reviewers, with 36 items (83.7%) meeting the threshold for inclusion. CONCLUSION: Through a completed Delphi consensus exercise we present the SCARE 2023 guidelines. This will provide surgeons with a comprehensive and up-to-date tool for documenting and reporting their surgical cases while highlighting the importance of patient-centred care.

Impact of diabetes on outcomes in breast reconstruction: A systematic review and meta-analysis.

BACKGROUND: As rates of breast cancer and type II diabetes increase, so does the number of women with diabetes undergoing breast reconstruction (BR). Patients with diabetes are at increased risk of postoperative complications. This meta-analysis seeks to evaluate the post-operative outcomes of women with diabetes who underwent BR following mastectomy. METHOD: This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The EMBASE, PUBMED, and MEDLINE electronic databases were searched from inception to November 1, 2020 for studies published in English. Outcomes evaluated were overall complications, surgical complications, and longer hospital stay. Subgroup analysis investigated outcomes, such as implant/flap failure, infection, and necrosis. RESULTS: Sixty-five studies met our inclusion criteria and 38 provided data to be included in the meta-analysis. A total of 151,585 patients were included, of which 9299 had diabetes. Women with diabetes were more likely to experience overall complications (11.6% vs 5.6%; p<0.0001) and surgical complications (7.7% vs 3.3%; p<0.0001), and were more likely to have a prolonged hospital stay (p = 0.04) than women without diabetes. Subgroup analysis showed that implant loss (2.5% vs 1.6%; p = 0.0003), infection (6.8% vs 2.5%; p<0.0001) and necrosis (23.8% vs 6.5; p = 0.001) were significantly higher in women with diabetes. CONCLUSIONS: This study provides evidence that diabetes mellitus increases the risk of complications in patients with breast cancer undergoing BR after mastectomy. Prospective studies are required to establish whether diabetes that is well-controlled prior to reconstruction, including diabetes that is paired with adjuvant radiation therapy, reduces the perioperative risks.

The SCARE 2020 Guideline: Updating Consensus Surgical CAse REport (SCARE) Guidelines.

INTRODUCTION: The SCARE Guidelines were first published in 2016 and were last updated in 2018. They provide a structure for reporting surgical case reports and are used and endorsed by authors, journal editors and reviewers, in order to increase robustness and transparency in reporting surgical cases. They must be kept up to date in order to drive forwards reporting quality. As such, we have updated these guidelines via a DELPHI consensus exercise. METHODS: The updated guidelines were produced via a DELPHI consensus exercise. Members were invited from the previous DELPHI group, as well as editorial board members and peer reviewers of the International Journal of Surgery Case Reports. The expert group completed an online survey to indicate their agreement with proposed changes to the checklist items. RESULTS: A total of 54 surgical experts agreed to participate and 53 (98%) completed the survey. The responses and suggested modifications were incorporated into the new 2020 guideline. There was a high degree of agreement amongst the SCARE Group, with all modified SCARE items receiving over 70% scores 7-9. CONCLUSION: A DELPHI consensus exercise was completed and an updated and improved SCARE Checklist is now presented.

The PROCESS 2020 Guideline: Updating Consensus Preferred Reporting Of CasESeries in Surgery (PROCESS) Guidelines.

INTRODUCTION: The PROCESS Guidelines were first published in 2016 and were last updated in 2018. They provide a structure for reporting surgical case series in order to increase reporting robustness and transparency, and are used and endorsed by authors, journal editors and reviewers alike. In order to drive forwards reporting quality, they must be kept up to date. As such, we have updated these guidelines via a DELPHI consensus exercise. METHODS: The updated guidelines were produced via a DELPHI consensus exercise. Members from the previous DELPHI group were again invited, alongside editorial board members and peer reviewers of the International Journal of Surgery and the International Journal of Surgery Case Reports. An online survey was completed by this expert group to indicate their agreement with proposed changes to the checklist items. RESULTS: A total of 53 surgical experts agreed to participate and 49 (92%) completed the survey. The responses and suggested modifications were incorporated into the previous 2018 guidelines. There was a high degree of agreement amongst the PROCESS Group, with all but one of the PROCESS items receiving over 70% of scores ranging 7-9. CONCLUSION: A DELPHI consensus exercise was completed and an updated and improved PROCESS Checklist is now presented.

A systematic review and meta-analysis of antibiotic prophylaxis in skin graft surgery: A protocol.

INTRODUCTION: There is little evidence-based guidance on the use of prophylactic antibiotics in skin surgery; whilst antibiotics may protect against surgical site infections (SSI), they have associated side effects, increase the risk of adverse events, and can propagate antibiotic resistance. We present a protocol for a systematic review to establish whether the benefit of prophylactic antibiotics overrides the risk, for patients undergoing autograft surgery. METHODS: The systematic review will be registered a priori on researchregistry.com and will be conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). A search strategy will be devised to investigate 'skin graft surgery and use of antibiotics'. The following electronic databases will be searched, 1979-2018: PubMed, MEDLINE®, EMBASE, SCOPUS, CINAHL, PsychINFO, SciELO, The Cochrane Library, including the Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effect (DARE), the Cochrane Methodology Register, Health Technology Assessment Database, the NHS Economic Evaluation Databases and Cochrane Groups, ClinicalTrials.gov, Current Controlled Trials Database, the World Health Organisation (WHO) International Clinical Trials Registry Platform, UpToDate.com, NHS Evidence and the York Centre for Reviews and Dissemination. Grey literature will be searched. All comparative study designs reporting on the use of antibiotics in skin graft surgery will be considered for inclusion, namely randomized controlled trials (RCTs). Two trained independent teams will screen all titles and abstracts, followed by relevant full texts, for eligibility. Data will be extracted under standardized extraction fields into a preformatted database. Note will be made of the indication for skin graft surgery (traumatic, congenital, malignant, benign), the graft site (head & neck, trunk, upper extremities, lower extremities), type of skin graft (split thickness, full-thickness). The primary outcome will be occurrence of SSI at the donor and/or recipient sites. Secondary outcomes, if reported, will include: length of hospital stay, revision surgery required, cost of medical care, time to wound healing and cosmetic outcome. ETHICS AND DISSEMINATION: The systematic review will be published in a peer-reviewed journal and presented at national and international meetings within fields of plastic, reconstructive, and aesthetic surgery. The work will be disseminated electronically and in print. Brief reports of the review and findings will be disseminated to interested parties through email and direct communication. The review aims to guide healthcare practice and policy.

Analysis of the first 2645 registrations at the research registry®: A global repository for all study types involving human participants.

BACKGROUND: The Declaration of Helsinki has called for the registration of all research studies involving human participants. Despite this, prior registries did not allow registration certain study types, or retrospective registration. The Research Registry® (www.researchregistry.com) was established in 2015 to provide a venue of registration for any study involving human participants. METHODS: and analysis: This retrospective database analysis describes the first 3000 registrations received by the Research Registry®. Since the launch of the Registry in 2015, we have collected data on each registration and excluded inappropriate registrations through a weekly curation process. The characteristics of all studies registered is presented. Each registration was marked against a quality score by two researchers acting independently, and we describe how this has changed over time. No ethical approval was required for this data only study including no human participants. RESULTS: Of 3000 registrations, we included 2645 that were submitted to the registry between February 2015 and October 2017. The number of registrations increased year on year, and we now receive between 60 and 80 registrations per month. One fifth of registrations were from China (537 [20.3%]). Retrospective observational studies were most commonly registered (1125 [42.5%]), and studies included in excess of 20 million patients (median 80 [IQR:25-200]). The quality score of registrations improved over the time (Kruskal-Wallis p < 0.05), and the 'control/comparator' component of the quality score was most poorly completed (completed by 1199 [54%]). CONCLUSION: The Research Registry® has received registrations on over 2500 registrations, including in excess of 20 million patients, with the quality of registrations improving over time. Retrospective observational studies and case series are the most commonly registered.

The SCARE 2018 statement: Updating consensus Surgical CAse REport (SCARE) guidelines.

INTRODUCTION: The SCARE Guidelines were published in 2016 to provide a structure for reporting surgical case reports. Since their publication, SCARE guidelines have been widely endorsed by authors, journal editors, and reviewers, and have helped to improve reporting transparency of case reports across a range of surgical specialties. In order to encourage further progress in reporting quality, the SCARE guidelines must themselves be kept up to date. We completed a Delphi consensus exercise to update the SCARE guidelines. METHODS: A Delphi consensus exercise was undertaken. All members of the previous Delphi group were invited to participate, in addition to researchers who have previously studied case reports, and editors from the International Journal of Surgery Case Reports. The expert group was sent an online questionnaire where they were asked to rate their agreement with proposed changes to each of the 24 items. RESULTS: 56 people agreed to participate and 45 (80%) invitees completed the survey which put forward modifications to the original guideline. The collated responses resulted in modifications. There was high agreement amongst the expert group. CONCLUSION: A modified and improved SCARE checklist is presented, after a Delphi consensus exercise was completed. The SCARE 2018 Statement: Updating Consensus Surgical CAse REport (SCARE) Guidelines.

The PROCESS 2018 statement: Updating Consensus Preferred Reporting Of CasE Series in Surgery (PROCESS) guidelines.

INTRODUCTION: The PROCESS guidelines were published in 2016 to provide a structure for reporting surgical case series. The PROCESS guidelines have since been widely endorsed by a number of journals. The requirement to report compliance with each item outlined in the PROCESS statement has improved the reporting transparency of case series across a number of surgical specialties. Here, we undertook a new Delphi consensus exercise to update the PROCESS guidelines. METHODS: All members of the previous Delphi group were invited to participate. In addition, researchers, editors, and reviewers who have previously published or reviewed case series with the International Journal of Surgery were invited to collaborate. An online questionnaire was sent to participants asking them to rate their agreement with amendments to each of the 29 items. RESULTS: 140 experts were invited to participate, 56 people agreed to participate, and 45 (80%) recipients completed the survey. There was a high level of agreement amongst the expert group, and unanimous consensus was reached in the first round. All except three proposed items were accepted, and the original guidelines were modified accordingly. CONCLUSION: A modified and improved PROCESS checklist is presented, after a Delphi consensus exercise was completed.

Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

BACKGROUND: Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction. METHODS: The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic. RESULTS: In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary. CONCLUSIONS: The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Impact of Obesity on Outcomes in Breast Reconstruction: A Systematic Review and Meta-Analysis.

BACKGROUND: Increased rates of both breast cancer and obesity have resulted in more obese women seeking breast reconstruction. Studies demonstrate that these women are at increased risk for perioperative complications. A systematic review was conducted to assess the outcomes in obese women who underwent breast reconstruction following mastectomy. METHODS: Cochrane, PUBMED, and EMBASE electronic databases were screened and data were extracted from included studies. The clinical outcomes assessed were surgical complications, medical complications, length of postoperative hospital stay, reoperation rate, and patient satisfaction. RESULTS: Out of 33 studies met the inclusion criteria for the review and 29 provided enough data to be included in the meta-analysis (71,368 patients, 20,061 of whom were obese). Obese women (body mass index > 30 kg/m2) were 2.29 times more likely to experience surgical complications (95% confidence interval (CI) 2.19-2.39; p < 0.00001), 2.89 times more likely to have medical complications (95% CI 2.50-3.35; p < 0.00001), and had a 1.91 times higher risk of reoperation (95% CI 1.75-2.07; p < 0.00001). The most common complication, wound dehiscence, was 2.51 times more likely in obese women (95% CI 1.80-3.52; p < 0.00001). Sensitivity analysis confirmed that obese women were more likely to experience surgical complications (risk ratio 2.36, 95% CI 2.22-2.52; p < 0.00001). CONCLUSIONS: This study provides evidence that obesity increases the risk of complications in both implant-based and autologous reconstruction. Additional prospective and observational studies are needed to determine if the weight reduction prior to reconstruction reduces the perioperative risks associated with obesity.

A protocol for the development of reporting guidelines for IDEAL stage studies.

BACKGROUND: New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice. We will develop a set of reporting guidelines for each IDEAL stage where deemed necessary through Delphi consensus methodology. METHODS: For each IDEAL stage requiring a new set of reporting guidelines, we will use the following process. We will search for the relevant reporting guidelines already in existence and use principles developed by the IDEAL Collaboration to compile the initial long list of potential checklist items. In each round, the participants will rate the importance of reporting each element on a nine-point Likert scale as proposed by the GRADE group. Sequential rounds and questionnaire administration and completion will take place until a final set of items is produced. There will then be a final consensus meeting of a working group to condense and refine the final recommendations for the reporting guidelines.

WHO Safer Surgery checklist compliance amongst paediatric emergency plastic surgery patients in an UK hospital.

INTRODUCTION: The WHO Safer Surgery checklist has become an important component of perioperative safety. Our objective, was to determine the compliance of completing the checklist for paediatric emergency plastic surgery patients at our unit. METHODS: An initial baseline was performed with 70 patients over two months at our unit. Following this, we raised awareness at an audit meeting and closed the audit loop using 80 patients over two months. The audit is reported in line with SQUIRE 2.0 criteria. RESULTS: Initial compliance was 88% overall and this increased to 91% post-intervention. Compliance with the individual stages in both cycles was for sign-in: 85%-86%, for time-out 92%-98% and for sign-out 86%-89%. Around one in four checklists were not scanned in both periods. CONCLUSION: This audit showed a high overall level of compliance in the checklists that were scanned and available for scrutiny. We have identified the areas that most need improvement and suggest ways for doing so.

Support for reporting guidelines in surgical journals needs improvement: A systematic review.

INTRODUCTION: Evidence-based medicine works best if the evidence is reported well. Past studies have shown reporting quality to be lacking in the field of surgery. Reporting guidelines are an important tool for authors to optimize the reporting of their research. The objective of this study was to analyse the frequency and strength of recommendation for such reporting guidelines within surgical journals. METHODS: A systematic review of the 198 journals within the Journal Citation Report 2014 (surgery category) published by Thomson Reuters was undertaken. The online guide for authors for each journal was screened by two independent groups and results compared. Data regarding the presence and strength of recommendation to use reporting guidelines was extracted. RESULTS: 193 journals were included (as five appeared twice having changed their name). These had a median impact factor of 1.526 (range 0.047-8.327), with a median of 145 articles published per journal (range 29-659), with 34,036 articles published in total over the two-year window 2012-2013. The majority (62%) of surgical journals made no mention of reporting guidelines within their guidelines for authors. Of the 73 (38%) that did mention them, only 14% (10/73) required the use of all relevant reporting guidelines. The most frequently mentioned reporting guideline was CONSORT (46 journals). CONCLUSIONS: The mention of reporting guidelines within the guide for authors of surgical journals needs improvement. Authors, reviewers and editors should work to ensure that research is reported in line with the relevant reporting guidelines. Journals should consider hard-wiring adherence to them.

The use of study registration and protocols in plastic surgery research: A systematic review.

BACKGROUND: In 2013, the Declaration of Helsinki changed to mandate that all research studies involving human subjects, rather than just clinical trials alone, must have a protocol registered in a publicly accessible database prior to the enrolment of the first patient. The objective of this work was to assess the number of research studies involving human participants published in leading journals of plastic surgery that had either published a protocol or registered a protocol with a publicly accessible database. MATERIALS AND METHODS: This systematic review examined all research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014-31st March 2015. The primary outcome measure was whether each study had either published or registered a protocol with any mainstream registry database. ClinicalTrials.gov, the International Standard Randomized Control Trial Number (ISRCTN) registry, the WHO (World Health Organisation) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed. RESULTS: Of 595 included articles, the most common study designs were case series (n = 185, 31.1%). There were 24 randomized controlled trials (RCTs, 4.0%). A total of 24 studies had a protocol registered (4.0%). The most common database to register a protocol was with ClinicalTrials.gov (n = 17). The study design that most commonly had a registered protocol was the RCT (n = 8 of 24, 33.3% of RCTs). Three studies published a protocol in a journal (0.6%). CONCLUSION: Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and guidance is provided.

Surveying opinions of 149 registrants to the Research Registry: Awareness of and attitudes towards research registration.

BACKGROUND: Research registration is an important ethical principle in the Declaration of Helsinki, however, progress to increase registration has been slow. Understanding the attitudes of users towards registries may provide insights into increase research registration. In this survey-based study, we sought to gain insight from users of a single global research registry, the Research Registry® (www.researchregistry.com). METHODS: A Google Forms survey was created and emailed to all users of the Research Registry® (n = 1432). Multiple choice and free-text answers were analyzed using descriptive statistics and thematic analysis respectively. RESULTS: From 925 contactable registrations, 149 (16.1%) completed the survey. The most commonly registered study type was retrospective cohort (32.2%). 23 registrations (15.4%) were made during the planning or conception of the study, whereas 67 (45.0%) registered at the time of journal submission, or during the peer review process. Of those that declared whether they had performed unregistered research or not, 51 (45.5%) participants had previously performed unregistered research. Registrants were most commonly made aware of the Research Registry® through submission to the International Journal of Surgery (IJS) family of journals (n = 57, 47.5%). Survey participants identified the most important features of registration to be its convenience, including the ease, time and cost of registration. Thematic analysis revealed the most common motive for registration to be as a mandatory requirement of journal submission, and that registration can be improved by simplification of the registration process. CONCLUSION: Registries must focus on engaging their network of users to ensure that research registration is a dynamic process. They need to adopt a user-centered and agile approach to their development, with a strong focus on "customer service". Moreover, by working in partnership with journals, it is possible to improve compliance with registration.

Describing the first 2000 registrations to the Research Registry®: A study protocol.

BACKGROUND: In 2013, the Declaration of Helsinki was updated and required the registration of all research studies involving human participants. Prior registries focussed on the registration of clinical trials and systematic reviews, and we estimate that only 10% of observational research is registered in a publically accessible registry. The Research Registry® was established to provide a venue of registration for any study, prospectively or retrospectively, involving human participants. This protocol describes the analysis for the first 2000 registrations received to the Research Registry®. METHODS AND ANALYSIS: Data for each registration to the Research Registry® (www.researchregistry.com), adapted from the World Health Organisation minimum data set, has been collected since the launch of the registry in 2015. A weekly curation process ensures that inappropriate registrations, such as duplicate studies or those not involving human participants, are removed from the registry. We will present the characteristics of the first 2000 registrations and how they have changed overtime. A quality score will be calculated for each registration by two independent teams, and inter-rater reliability will be calculated. Funding sources of work registered will also be presented. This process will also be performed for the systematic review portion of the registry ('The Review Registry'), which will be considered separately. ETHICS AND DISSEMINATION: Ethical approval is not required for this study as it involves no human participants. The findings will be presented at international conferences and published in a peer reviewed journal.

A protocol for the development of the STROCSS guideline: Strengthening the Reporting of Cohort Studies in Surgery.

INTRODUCTION: Strengthening the reporting of observational studies in epidemiology (STROBE) coined in 2007, highlighted the importance of improving the quality of observational research by providing an item checklist in order to avoid inadequate reporting of research. However, currently there are no reporting guidelines specific to surgical cohort studies, which have an extremely important role within the surgical literature. The recent development of surgery specific guidelines has underscored how surgical and procedural interventions require additional detail for readers to have a complete, clear, transparent and reproducible understanding. The objective of this research is to conduct a Delphi consensus exercise to develop the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS: Current guidelines for case series (PROCESS), Cohort Studies (STROBE) and randomised controlled trials (CONSORT) will be analysed to compile items to form baseline material for developing cohort guidelines in the Delphi consensus exercise. The Delphi questionnaire will be administered via Google Forms and conducted using standard Delphi Methodology. Surgeons and individuals with significant experience of reviewing cohort studies as well as those with experience in developing reporting guidelines will be invited to participate. In the first round, existing items from PROCESS and STROBE will be put forward and participants will be invited to augment them or contribute further items for consideration. The provisional guidelines will then be updated in successive rounds using the nine-point Likert scale as proposed by the Grading Recommendations, Assessment, Development, and Evaluations (GRADE) working group. This process will be used to agree Standard definitions for the outcomes. DISSEMINATION: The work will be published in a peer-reviewed journal and presented at national and international meetings. Findings will be disseminated to interested parties, and journals will be encouraged to endorse the reporting guidelines.