Evaluation of the Completeness of Interventions Reported in Published Randomized Controlled Trials in Plastic Surgery: A Systematic Review.

BACKGROUND: With the increasing number of randomized control trials being conducted and published in plastic surgery, complete reporting of trial information is critical for readers to properly evaluate a trial's methodology and arrive at appropriate conclusions about its merits and applicability to patients. The Template for Intervention Description and Replication (TIDieR) checklist was introduced to address the limited guidance for reporting trial interventions. OBJECTIVES: The authors applied the TIDieR checklist to evaluate the completeness of intervention reporting of randomized control trials in plastic surgery, compare the quality of intervention reporting before and after the guideline was published, and evaluate characteristics associated with TIDieR compliance. METHODS: A PubMed search identified 1 cohort published prior to the release of TIDieR and another published after its release. From the final sample, the TIDieR checklist was applied to intervention descriptions, and relevant study characteristics were extracted in a duplicate, blinded manner. RESULTS: In total, 130 trials were included for analysis. The mean TIDieR score was 6.4 of 12. Five items were reported 90% of the time, and 4 items were reported less than 10% of the time. We found that TIDieR publication did not affect intervention reporting (P = 0.22). CONCLUSIONS: Our study identified areas in which intervention reporting could be improved. The extent of TIDieR adoption by trialists appears to be limited, and greater efforts are needed to disseminate this reporting guideline if widespread uptake is to be expected. Alternately, it may be beneficial to incorporate TIDieR into the more widely recognized Consolidated Standards of Reporting Trials statement.

No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations.

OBJECTIVE: To update, clarify, and extend IDEAL concepts and recommendations. BACKGROUND: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. METHODS: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions-Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a "Pre-IDEAL" stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. CONCLUSIONS: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.

Progress in clinical research in surgery and IDEAL.

The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations specify desirable qualities for surgical studies, and outline an integrated evaluation pathway for surgery, and similar complex interventions. We used the IDEAL Recommendations to assess methodological progress in surgical research over time, assessed the uptake and influence of IDEAL, and identified the challenges to further methodological progress. Comparing studies from the periods 2000-04 and 2010-14, we noted apparent improvement in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves, but no progress in the use of qualitative research or reporting of modifications during procedure development. Better education about research, integration of rigorous evaluation into routine practice and training, and linkage of such work to awards systems could foster further improvements in surgical evidence. IDEAL has probably contributed only slightly to the improvements described to date, but its uptake is accelerating rapidly. The need for the integrated evaluation template IDEAL offers for surgery and other complex treatments is becoming more widely accepted.

Assessing the Compliance of Randomized Controlled Trials Published in Craniofacial Surgery Journals With the CONSORT Statement.

BACKGROUND: Randomized controlled trials (RCTs) are gold standard assessments for healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) statement was published to maximize RCT reporting transparency. The authors conducted a systematic review to assess current compliance of RCTs published within craniofacial surgery with the CONSORT statement. METHODS: The Thomson Reuters Impact Factor Report 2016 was consulted to identify craniofacial surgery journals. PubMed was used to search for recent RCTs published within the 5 journals identified. Two independent researchers assessed each study for inclusion and performed data extraction. The primary outcome was compliance of each RCT with the CONSORT statement. Secondary outcomes were the pathology and interventions examined, impact factor, multi-versus-single center, number of authors, and publication date. RESULTS: Eighty-six studies met the inclusion criteria, across which a median of 56% (range 33%-94%) applicable CONSORT items were reported. The 5 least reported items were: trial design (3a); registration number and name of trial registry (23); who generated random allocation sequences, enrolled participants, and assigned participants to interventions (10); sample size determination (7a); mentioning "randomized trial" in the title (1a). CONCLUSION: The compliance of craniofacial surgery RCTs with the CONSORT statement requires improvement. Areas in need are identified, and methods to improve reporting transparency, are discussed.

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.

Compliance of systematic reviews in ophthalmology with the PRISMA statement.

BACKGROUND: Systematic reviews and meta-analyses are becoming increasingly important methods to summarize published research. Studies of ophthalmology may present additional challenges because of their potentially complex study designs. The aim of this study was to evaluate the reporting quality of systematic reviews and meta-analyses on topics in ophthalmology to determine compliance with the PRISMA guidelines. We assessed articles published between 2010 and 2015 in the five major relevant journals with the highest impact factors. METHODS: The MEDLINE and EMBASE databases were searched to identify systematic reviews published between January 2010 and December 2015 in the following 5 major ophthalmology journals: Progress in Retinal and Eye Research, Ophthalmology, Archives of Ophthalmology, American Journal of Ophthalmology, and Survey of Ophthalmology. The screening, identification, and scoring of articles were independently performed by two teams, and the results were submitted to statistical analysis to determine medians, ranges, and 95% CIs. RESULTS: A total of 115 articles were included. The median compliance was 15 out of 27 items (56%), the range was 5-26 (26-96%), and the inter-quartile range was 10 (37%). Compliance was highest in items related to the 'description of rationale' (item 3, 100%) and sequentially lower in 'the general interpretation of results' (item 26, 96%) and 'the inclusion of a structured summary in the abstract' (item 2, 90%). Compliance was poorest in the items 'indication of review protocol and registration' (item 5, 9%), 'specification of risk of biases that may affect the cumulative evidence' (item 15, 24%), and 'description of clear objectives in the introduction' (item 4, 26%). CONCLUSION: The reporting quality of systematic reviews and meta-analyses in ophthalmology should be significantly improved. While we recommend the use of the PRISMA criteria as a guideline before journal submission, additional research aimed at identifying potential barriers to compliance may be required to improve compliance with PRISMA guidelines.

Reporting Quality of Observational Studies in Plastic Surgery Needs Improvement: A Systematic Review.

INTRODUCTION: Our objective was to determine the compliance of observational studies in plastic surgery with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement checklist. METHODS: All cohort, cross-sectional, and case-control studies published in five major plastic surgery journals in 2013 were assessed for their compliance with the STROBE statement. RESULTS: One hundred thirty-six studies were identified initially and 94 met the inclusion criteria. The average STROBE score was 12.4 (range, 2-20.1) with a standard deviation of 3.36. The most frequent reporting deficiencies were not reporting the study design in the title and abstract 30% compliance; describing the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection (24%); describing efforts to address sources of bias (20%); reporting numbers of individuals at each stage of the study (20%); and discussing limitations (40%). CONCLUSIONS: The reporting quality of observational studies in Plastic Surgery needs improvement. We suggest ways this could be improved including better education, awareness among all stakeholders, and hardwiring compliance through electronic journal submission systems.

The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction.

INTRODUCTION: There is growing interest in autologous fat grafting (AFG) for breast reconstruction. This systematic review examines the range of outcomes used across studies of AFG, their definitions and whether there is a need for a core outcome set to aid reporting. METHODS: Following the protocol of our systematic review, a search of 20 databases (1986 to March 2014) returned 35 studies which met the inclusion criteria. These were assessed independently by two authors. Disagreements were resolved by consensus. RESULTS: Of the 35 studies, 27 (77%) were case series, 5 (14.3%) were cohort studies, and 3 (8.6%) were case reports. A total of 51 different outcomes were reported. These studies each reported a median of five separate outcomes (range, 2-14), of which a median of 3 outcomes were defined (range, 0-14). A median of 2 outcomes per paper were prespecified in the study methods (range, 0-12) and a median of only 2 outcomes per paper (range, 0-12) were both defined and prespecified. The most commonly reported outcome in studies of AFG was that of "operative details," reported by 26 studies, and eight different outcome definitions were used. "Cancer recurrence" was reported by 20 studies, with the use of 10 different outcome definitions. Overall, there was a poor proportion of defined and prespecified outcomes that employed a wide range of different outcome definitions. In addition only 14/35 studies stated the number of patients lost to follow-up. CONCLUSIONS: There is a need for a core outcomes set for AFG to the breast to minimise outcome and reporting bias and aid evidence synthesis. Our future research will focus in this direction, titled VOGUE or Valid Outcomes for the Grafting of AUtologous Fat to the BrEast study. We invite all those interested to get in touch with the lead author.

Evidence-Based Plastic Surgery: Its Rise, Importance, and a Practical Guide.

There is a perfect storm developing in 21st century healthcare; rising complexity and patient expectations in the context of fiscal restraint. Evidence-based medicine (EBM) may be the best-kept secret in dealing with the "storm." Such an approach prefers management pathways that deliver better outcomes at less relative cost. In this article, the rise of EBM, its significance, a guide to practicing it, and its future in the field of plastic, reconstructive, and aesthetic surgery are presented.

Surveillance and quality improvement in the United Kingdom: is there a meeting point?

Recent high profile failures within the National Health Service of England and Wales have highlighted the need for surveillance of quality and performance. Mortality is the most commonly used metric, assessed at the hospital or trust level. However overall mortality can mask where the failures lie and even if they exist. Continuous surveillance at a granular level is needed, especially in surgery where interventions need to be safe, reliable and efficacious but so does the coordination of care along the entire patient pathway with robust protocols and mechanisms in place to prevent 'failure to rescue' and to optimise patient outcomes. There is an expanding body of surveillance tools available for surgical practice and these are beginning to show merit. The Care Quality Commission, who monitor services, increasingly through ongoing surveillance as well as inspections, should work more closely with local quality improvement efforts and become a vector for care excellence, actively involved with spreading best practice throughout the entire NHS and not just for identifying the 'bad apples'.

The validity of surgical simulation.

Simulation is playing an increasingly important role in training surgeons. As hours between registrar and consultant grades have decreased, trainees are required to train smarter. While the majority of simulation is limited, advances in computing and design are enabling ever more realistic, varied simulation.

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, the authors 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: The authors 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.

Perioperative fluid restriction in major abdominal surgery: systematic review and meta-analysis of randomized, clinical trials.

BACKGROUND: Fluid management is a fundamental component of surgical care. Recently, there has been considerable interest in perioperative fluid restriction as a method of facilitating recovery following elective major surgery. A number of randomized trials have addressed the issue in various surgical specialities, and a recent meta-analysis proposed uniform definitions regarding fluid amount as well as examining fluid restriction in patients undergoing colonic resection. METHODS: Medline, Embase, trial registries, conference proceedings, and article reference lists were searched to identify randomized, controlled trials of perioperative fluid restriction versus "standard" perioperative fluid management, as per definitions formulated previously. All of the studies involved patients undergoing colonic resection. The primary outcome measure was postoperative morbidity. Secondary endpoints included mortality, renal failure, time to first flatus, and length of hospital stay. A random effects model was applied. RESULTS: Seven randomized, controlled trials with a total of 856 patients investigating standard versus restrictive fluid regimes, as denoted by the definitions, were included. Perioperative fluid restriction had no effect on the risk of postoperative complications (OR 0.49 (95 % confidence interval (CI) 0.2-1.18; P = 0.101). There was no detectable effect on death and fluid restriction did not reduce hospital stay (Pooled weighted mean difference -0.25; 95 % CI 0.72-0.21; P = 0.29). CONCLUSIONS: Perioperative fluid restriction does not significantly reduce the risk of complications following major abdominal surgery. Furthermore, it does not appear to reduce length of hospital stay.

Preferred Reporting Of Case Series in Surgery (PROCESS) 2023 guidelines.

INTRODUCTION: The Preferred Reporting Of CasE Series in Surgery (PROCESS) guidelines were developed in 2016 in order to improve the reporting quality of surgical case series. Since its inception, it has been updated twice, in 2018 and 2020, and has been cited over 1000 times. PROCESS guidelines have enjoyed great acceptance within the surgical research community. Our aim is to update the PROCESS guidelines in order to maintain its applicability in the field of surgical research. METHODS: A PROCESS 2023 steering group was created. By working in collaboration, members of this group came up with proposals to update the PROCESS 2020 guidelines. These proposals were presented to an expert panel of researchers, who in turn scrutinised these proposals and decided whether they should become part of PROCESS 2023 guidelines or not, through a Delphi consensus exercise. RESULTS: A total of 38 people participated in the development of PROCESS 2023 guidelines. The majority of items received a score between 7 and 9 from greater than 70% of the participants, indicating consensus with the proposed changes to those items. However, two items (3c and 6a) received a score between 7 and 9 from less than 70% of the participants, indicating a lack of consensus with the proposed changes to those items. Those items will remain unchanged. DISCUSSION: The updated PROCESS 2023 guidelines are presented with an aim to continue improving the reporting quality of case series 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.

Bibliometric analysis of academic journal recommendations and requirements for surgical and anesthesiologic adverse events reporting.

BACKGROUND: Standards for reporting surgical adverse events (AEs) vary widely within the scientific literature. Failure to adequately capture AEs hinders efforts to measure the safety of healthcare delivery and improve the quality of care. The aim of the present study is to assess the prevalence and typology of perioperative AE reporting guidelines among surgery and anesthesiology journals. MATERIALS AND METHODS: In November 2021, three independent reviewers queried journal lists from the SCImago Journal & Country Rank (SJR) portal (www.scimagojr.com), a bibliometric indicator database for surgery and anesthesiology academic journals. Journal characteristics were summarized using SCImago, a bibliometric indicator database extracted from Scopus journal data. Quartile 1 (Q1) was considered the top quartile and Q4 bottom quartile based on the journal impact factor. Journal author guidelines were collected to determine whether AE reporting recommendations were included and, if so, the preferred reporting procedures. RESULTS: Of 1409 journals queried, 655 (46.5%) recommended surgical AE reporting. Journals most likely to recommend AE reporting were: by category surgery (59.1%), urology (53.3%), and anesthesia (52.3%); in top SJR quartiles (i.e. more influential); by region, based in Western Europe (49.8%), North America (49.3%), and the Middle East (48.3%). CONCLUSIONS: Surgery and anesthesiology journals do not consistently require or provide recommendations on perioperative AE reporting. Journal guidelines regarding AE reporting should be standardized and are needed to improve the quality of surgical AE reporting with the ultimate goal of improving patient morbidity and mortality.

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.

A review of the role of mechanical forces in cutaneous wound healing.

Cutaneous wound healing is a complex process with many types of mechanical forces regulating the quality and speed of healing. The role of mechanical forces in regulating tissue growth, repair and remodelling was recognised more than a century ago. Such forces influence gene expression, the synthesis of growth factors and inflammatory mediators and cellular processes like proliferation of many load-sensitive cells. However, the exact mechanisms by which these forces interact with cells and ways to use them to stimulate tissues are still active research fronts. This article sets to review the literature on mechanical forces and their role in cutaneous wound healing.