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

Randomised controlled trials in plastic surgery: a systematic review of reporting quality

Background: We recently conducted a systematic review of the methodological quality of randomised controlled trials (RCTs) in plastic surgery. In accordance with convention, we are here separately reporting a systematic review of the reporting quality of the same RCTs. Methods: MEDLINE® and the Cochrane Database of Systematic Reviews were searched by an information specialist from 1 January 2009 to 30 June 2011 for the MESH heading ‘Surgery, Plastic’. Limitations were entered for English language, human studies and randomised controlled trials. Manual searching for RCTs involving surgical techniques was performed within the results. Scoring of the eligible papers was performed against the 23-item CONSORT Statement checklist. Independent secondary scoring was then performed and discrepancies resolved through consensus. Results: Fifty-seven papers met the inclusion criteria. The median CONSORT score was 11.5 out of 23 items (range 5.3–21.0). Items where compliance was poorest included intervention/comparator details (7 %), randomisation implementation (11 %) and blinding (26 %). Journal 2010 impact factor or number of authors did not significantly correlate with CONSORT score (Spearman rho = 0.25 and 0.12, respectively). Only 61 % declared conflicts of interest, 75 % permission from an ethics review committee, 47 % declared sources of funding and 16 % stated a trial registry number. There was no correlation between the volume of RCTs performed in a particular country and reporting quality. Conclusions: The reporting quality of RCTs in plastic surgery needs improvement. Better education, awareness amongst all stakeholders and hard-wiring compliance through electronic journal submission systems could be the way forward. We call for the international plastic surgical community to work together on these long-standing problems

Impact of COVID-19 on cardiovascular testing in the United States versus the rest of the world

Objectives: This study sought to quantify and compare the decline in volumes of cardiovascular procedures between the United States and non-US institutions during the early phase of the coronavirus disease-2019 (COVID-19) pandemic. Background: The COVID-19 pandemic has disrupted the care of many non-COVID-19 illnesses. Reductions in diagnostic cardiovascular testing around the world have led to concerns over the implications of reduced testing for cardiovascular disease (CVD) morbidity and mortality. Methods: Data were submitted to the INCAPS-COVID (International Atomic Energy Agency Non-Invasive Cardiology Protocols Study of COVID-19), a multinational registry comprising 909 institutions in 108 countries (including 155 facilities in 40 U.S. states), assessing the impact of the COVID-19 pandemic on volumes of diagnostic cardiovascular procedures. Data were obtained for April 2020 and compared with volumes of baseline procedures from March 2019. We compared laboratory characteristics, practices, and procedure volumes between U.S. and non-U.S. facilities and between U.S. geographic regions and identified factors associated with volume reduction in the United States. Results: Reductions in the volumes of procedures in the United States were similar to those in non-U.S. facilities (68% vs. 63%, respectively; p = 0.237), although U.S. facilities reported greater reductions in invasive coronary angiography (69% vs. 53%, respectively; p < 0.001). Significantly more U.S. facilities reported increased use of telehealth and patient screening measures than non-U.S. facilities, such as temperature checks, symptom screenings, and COVID-19 testing. Reductions in volumes of procedures differed between U.S. regions, with larger declines observed in the Northeast (76%) and Midwest (74%) than in the South (62%) and West (44%). Prevalence of COVID-19, staff redeployments, outpatient centers, and urban centers were associated with greater reductions in volume in U.S. facilities in a multivariable analysis. Conclusions: We observed marked reductions in U.S. cardiovascular testing in the early phase of the pandemic and significant variability between U.S. regions. The association between reductions of volumes and COVID-19 prevalence in the United States highlighted the need for proactive efforts to maintain access to cardiovascular testing in areas most affected by outbreaks of COVID-19 infection

Non-invasive diagnostic tests for Helicobacter pylori infection

BACKGROUND: Helicobacter pylori (H pylori) infection has been implicated in a number of malignancies and non-malignant conditions including peptic ulcers, non-ulcer dyspepsia, recurrent peptic ulcer bleeding, unexplained iron deficiency anaemia, idiopathic thrombocytopaenia purpura, and colorectal adenomas. The confirmatory diagnosis of H pylori is by endoscopic biopsy, followed by histopathological examination using haemotoxylin and eosin (H & E) stain or special stains such as Giemsa stain and Warthin-Starry stain. Special stains are more accurate than H & E stain. There is significant uncertainty about the diagnostic accuracy of non-invasive tests for diagnosis of H pylori. OBJECTIVES: To compare the diagnostic accuracy of urea breath test, serology, and stool antigen test, used alone or in combination, for diagnosis of H pylori infection in symptomatic and asymptomatic people, so that eradication therapy for H pylori can be started. SEARCH METHODS: We searched MEDLINE, Embase, the Science Citation Index and the National Institute for Health Research Health Technology Assessment Database on 4 March 2016. We screened references in the included studies to identify additional studies. We also conducted citation searches of relevant studies, most recently on 4 December 2016. We did not restrict studies by language or publication status, or whether data were collected prospectively or retrospectively. SELECTION CRITERIA: We included diagnostic accuracy studies that evaluated at least one of the index tests (urea breath test using isotopes such as13C or14C, serology and stool antigen test) against the reference standard (histopathological examination using H & E stain, special stains or immunohistochemical stain) in people suspected of having H pylori infection. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the references to identify relevant studies and independently extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We performed meta-analysis by using the hierarchical summary receiver operating characteristic (HSROC) model to estimate and compare SROC curves. Where appropriate, we used bivariate or univariate logistic regression models to estimate summary sensitivities and specificities. MAIN RESULTS: We included 101 studies involving 11,003 participants, of which 5839 participants (53.1%) had H pylori infection. The prevalence of H pylori infection in the studies ranged from 15.2% to 94.7%, with a median prevalence of 53.7% (interquartile range 42.0% to 66.5%). Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics.There was at least an unclear risk of bias or unclear applicability concern for each study.Of the 101 studies, 15 compared the accuracy of two index tests and two studies compared the accuracy of three index tests. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13C; 21 studies (1810 participants) evaluated urea breath test-14C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used. The thresholds used to define test positivity and the staining techniques used for histopathological examination (reference standard) varied between studies. Due to sparse data for each threshold reported, it was not possible to identify the best threshold for each test.Using data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024). The diagnostic odds ratios for urea breath test-13C, urea breath test-14C, serology, and stool antigen test were 153 (95% confidence interval (CI) 73.7 to 316), 105 (95% CI 74.0 to 150), 47.4 (95% CI 25.5 to 88.1) and 45.1 (95% CI 24.2 to 84.1). The sensitivity (95% CI) estimated at a fixed specificity of 0.90 (median from studies across the four tests), was 0.94 (95% CI 0.89 to 0.97) for urea breath test-13C, 0.92 (95% CI 0.89 to 0.94) for urea breath test-14C, 0.84 (95% CI 0.74 to 0.91) for serology, and 0.83 (95% CI 0.73 to 0.90) for stool antigen test. This implies that on average, given a specificity of 0.90 and prevalence of 53.7% (median specificity and prevalence in the studies), out of 1000 people tested for H pylori infection, there will be 46 false positives (people without H pylori infection who will be diagnosed as having H pylori infection). In this hypothetical cohort, urea breath test-13C, urea breath test-14C, serology, and stool antigen test will give 30 (95% CI 15 to 58), 42 (95% CI 30 to 58), 86 (95% CI 50 to 140), and 89 (95% CI 52 to 146) false negatives respectively (people with H pylori infection for whom the diagnosis of H pylori will be missed).Direct comparisons were based on few head-to-head studies. The ratios of diagnostic odds ratios (DORs) were 0.68 (95% CI 0.12 to 3.70; P = 0.56) for urea breath test-13C versus serology (seven studies), and 0.88 (95% CI 0.14 to 5.56; P = 0.84) for urea breath test-13C versus stool antigen test (seven studies). The 95% CIs of these estimates overlap with those of the ratios of DORs from the indirect comparison. Data were limited or unavailable for meta-analysis of other direct comparisons. AUTHORS' CONCLUSIONS: In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions

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&amp;percnt; of 595 recent research studies and 0.5&amp;percnt; 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&amp;percnt; registered their study at the time of journal submission. The GFA analysis showed 62&amp;percnt; didn’t mention reporting guidelines at all (n=193). Subsequent mandatory implementation in a single surgical journal, increased compliance with STROBE by 12&amp;percnt; (n=152), with CONSORT by 40&amp;percnt; (n=13) and with PRISMA by 58&amp;percnt; (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.</p

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&percnt; of 595 recent research studies and 0.5&percnt; 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&reg; 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&percnt; registered their study at the time of journal submission. The GFA analysis showed 62&percnt; didnât mention reporting guidelines at all (n=193). Subsequent mandatory implementation in a single surgical journal, increased compliance with STROBE by 12&percnt; (n=152), with CONSORT by 40&percnt; (n=13) and with PRISMA by 58&percnt; (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.</p

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 case series 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