Riaz A. Agha

The SCARE Statement: Consensus-based surgical case report guidelines

INTRODUCTION Case reports have been a long held tradition within the surgical literature. Reporting guidelines can improve transparency and reporting quality. However, recent consensus-based guidelines for case reports (CARE) are not surgically focused. Our objective was to develop surgical case report guidelines. METHODS The CARE statement was used as the basis for a Delphi consensus. The Delphi questionnaire was administered via Google Forms and conducted using standard Delphi methodology. A multidisciplinary group of surgeons and others with expertise in the reporting of case reports were invited to participate. In round one, participants stated how each item of the CARE statement should be changed and what additional items were needed. Revised and additional items from round one were put forward into a further round, where participants voted on the extent of their agreement with each item, using a nine-point Likert scale, as proposed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group. RESULTS In round one, there was a 64% (38/59) response rate. Following adjustment of the guideline with the incorporation of recommended changes, round two commenced and there was an 83% (49/59) response rate. All but one of the items were approved by the participants, with Likert scores 7-9 awarded by >70% of respondents. The final guideline consists of a 14-item checklist. CONCLUSION We present the SCARE Guideline, consisting of a 14-item checklist that will improve the reporting quality of surgical case reports.

The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery

INTRODUCTION The development of reporting guidelines over the past 20 years represents a major advance in scholarly publishing with recent evidence showing positive impacts. Whilst over 350 reporting guidelines exist, there are few that are specific to surgery. Here we describe the development of the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS We published our protocol apriori. Current guidelines for case series (PROCESS), cohort studies (STROBE) and randomised controlled trials (CONSORT) were analysed to compile a list of items which were used as baseline material for developing a suitable checklist for surgical cohort guidelines. These were then put forward in a Delphi consensus exercise to an expert panel of 74 surgeons and academics via Google Forms. RESULTS The Delphi exercise was completed by 62% (46/74) of the participants. All the items were passed in a single round to create a STROCSS guideline consisting of 17 items. CONCLUSION We present the STROCSS guideline for surgical cohort, cross-sectional and case-control studies consisting of a 17-item checklist. We hope its use will increase the transparency and reporting quality of such studies. This guideline is also suitable for cross-sectional and case control studies. We encourage authors, reviewers, journal editors and publishers to adopt these guidelines.

Preferred reporting of case series in surgery; the PROCESS guidelines

INTRODUCTION Case series have been a long held tradition within the surgical literature and are still frequently published. Reporting guidelines can improve transparency and reporting quality. No guideline exists for reporting case series, and our recent systematic review highlights the fact that key data are being missed from such reports. Our objective was to develop reporting guidelines for surgical case series. METHODS A Delphi consensus exercise was conducted to determine items to include in the reporting guideline. Items included those identified from a previous systematic review on case series and those included in the SCARE Guidelines for case reports. The Delphi questionnaire was administered via Google Forms and conducted using standard Delphi methodology. Surgeons and others with expertise in the reporting of case series were invited to participate. In round one, participants voted to define case series and also what elements should be included in them. In round two, participants voted on what items to include in the PROCESS guideline using a nine-point Likert scale to assess agreement as proposed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group. RESULTS In round one, there was a 49% (29/59) response rate. Following adjustment of the guideline with incorporation of recommended changes, round two commenced and there was an 81% (48/59) response rate. All but one of the items were approved by the participants and Likert scores 7-9 were awarded by >70% of respondents. The final guideline consists of an eight item checklist. CONCLUSION We present the PROCESS Guideline, consisting of an eight item checklist that will improve the reporting quality of surgical case series. We encourage authors, reviewers, editors, journals, publishers and the wider surgical and scholarly community to adopt these.

A protocol for the development of reporting criteria for surgical case reports: The SCARE statement

INTRODUCTION Case reports have specific relevance within the surgical literature. The Case Report Guidelines (CARE) were developed in 2013 to provide a framework to support accuracy in the publication of case reports. As such, they have been adopted by multiple journals. However, they are not tailored to surgery. The objective of this research is to conduct a Delphi consensus exercise amongst experienced case report reviewers and editors to develop the Surgical CAse REport (SCARE) Guidelines. METHODS AND ANALYSIS The CARE statement will be used as the basis for this Delphi consensus exercise. The Delphi questionnaire will be administered via SurveyMonkey and conducted using standard Delphi Methodology. Surgeons and others with significant experience in reviewing case reports will be invited to participate. There is no pre-determined number of Delphi rounds, although the expectation is that at least three will be needed. Initially, interested parties will be invited to contribute further items for consideration. Then, in each subsequent round, the participants will rate the importance of reporting each outcome on a nine-point Likert scale as proposed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group. This process will also be used to agree standard definitions for the outcomes. DISSEMINATION This work will be disseminated through publication and will be presented at national and international meetings. The findings will be disseminated to interested parties, and journals will be encouraged to endorse the reporting guideline.

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.

Compliance of randomized controlled trials in trauma surgery with the CONSORT statement.

BACKGROUND Randomized controlled trials (RCTs) are the criterion standard for assessing new interventions. However, bias can result from poor reporting, which also makes critical appraisal and systematic review challenging. The Consolidated Standards of Reporting Trials (CONSORT) criteria for nonpharmacological trials published in 2008 provided a set of 23 mandatory items that should be reported in an RCT. This is the first study to assess the compliance of RCTs in trauma with the CONSORT criteria for nonpharmacological trials. METHODS The MEDLINE database was searched using the MeSH term wounds and injuries for English-language articles published between January 2009 and December 2011. Relevant articles were scored by two reviewers and compared against surrogate markers of article quality (such as journal impact factor). RESULTS Eighty-three articles were deemed suitable for inclusion. The mean CONSORT score was 11.2 of 23 items (49%; range, 3.38–18.17). Compliance was poorest for items relating to the adherence of care providers (0%), abstract (5%), and implementation of randomization (6%). Only 40% declared conflicts of interest, 73% declared permission from an ethics review committee, 43% declared sources of funding, and 10% stated a trial registry number. There was a significant correlation between the CONSORT score and the impact factor of the publishing journal (&rgr; = 0.37, p = 0.0006) but not for the number of patients or authors or single versus multicentre trials CONCLUSION The reporting quality of RCTs in trauma surgery needs improvement. We suggest ways by which this could be improved including the following: better education, awareness, and a cohesive strategy among all stakeholders and the hard wiring of compliance through electronic journal submission systems.

The role of non-technical skills in surgery

Non-technical skills are of increasing importance in surgery and surgical training. A traditional focus on technical skills acquisition and competence is no longer enough for the delivery of a modern, safe surgical practice. This review discusses the importance of non-technical skills and the values that underpin successful modern surgical practice. This narrative review used a number of sources including written and online, there was no specific search strategy of defined databases. Modern surgical practice requires; technical and non-technical skills, evidence-based practice, an emphasis on lifelong learning, monitoring of outcomes and a supportive institutional and health service framework. Finally these requirements need to be combined with a number of personal and professional values including integrity, professionalism and compassionate, patient-centred care.

Side population hematopoietic stem cells promote wound healing in diabetic mice

Background: Early evidence suggests that stem cells play a role in normal wound healing. Various impaired wound-healing states might be due to a deficiency in the stem cell repertoire. The authors sought to demonstrate that a new subset of lymphoid progenitor murine hematopoietic stem cells will accelerate wound healing in diabetic mice. Methods: Bone marrow cells were harvested from C57Bl6/J femurs and separated into side and main populations based on their ability to efflux the vital dye Hoechst 33342 and the presence or absence of CD7 and CD34 markers. Side or main population cells and control solution were applied once topically to 1-cm2 full-thickness dorsal excisional wounds in lepr db/db and wild-type mice on the day after wounding (n = 12 in each group). Wound closure was followed by computer planimetry. Wounds were harvested after 7 and 25 days for histological analysis. Results: Topical side population treatment had a significant effect on wound closure in diabetic animals, with a higher percentage of wound closure (35 ± 7.2 percent) in this group on postoperative day 7 compared with animals treated with either main population cells (16 ± 4.9 percent) or a vehicle control using saline (14 ± 6.7 percent) (p < 0.05). When side population cells were given to wild-type mice that already had a normal stem cell repertoire, there was a trend toward better wound closure, but no significant differences were found. Conclusions: Side population–treated wounds healed more quickly than main population–or control-treated wounds in diabetic mice, suggesting that one stem cell subpopulation, but not the majority, harbors the potential for improving the healing process. Further studies are needed to investigate the mechanism of healing and to explore its potential as a therapeutic agent.

Practical guide to the Idea, Development and Exploration stages of the IDEAL Framework and Recommendations.

Evaluation of new surgical procedures is a complex process challenged by evolution of technique, operator learning curves, the possibility of variable procedural quality, and strong treatment preferences among patients and clinicians. Preliminary studies that address these issues are needed to prepare for a successful randomized trial. The IDEAL (Idea, Development, Exploration, Assessment and Long‐term follow‐up) Framework and Recommendations provide an integrated step‐by‐step evaluation pathway that can help investigators achieve this.

Compliance of Systematic Reviews in Plastic Surgery With the PRISMA Statement

IMPORTANCE Systematic reviews attempt to answer research questions by synthesizing the data in primary articles. They are an increasingly important tool within evidence-based medicine, guiding clinical practice, future research, and health care policy. OBJECTIVE To determine the reporting quality of recent systematic reviews and meta-analyses in plastic surgery with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. METHODS MEDLINE and EMBASE were searched for systematic reviews published between January 1, 2013, and December 31, 2014, in 5 major plastic surgery journals. Screening, identification, and data extraction were performed independently by 2 teams. Articles were reviewed for compliance with reporting of 27 items in the PRISMA checklist. Data analysis was conducted from January 1 to July 30, 2015. MAIN OUTCOMES AND MEASURES The sum of PRISMA checklist items (1-27) per systematic review. RESULTS From an initial set of 163 articles, 79 met the inclusion criteria. The median PRISMA score was 16 of 27 items (59%) (range, 6%-26%; 95% CI, 14%-17%). Compliance varied between individual PRISMA items. It was poorest for items related to the use of review protocol (item 5; 4 articles [5%]) and presentation of data on the risk of bias of each study (item 19; 14 articles [18%]). Compliance was the highest for description of rationale (item 3; 78 articles [99%]), sources of funding and other support (item 27; 75 articles [95%]), and inclusion of a structured summary in the abstract (item 2; 75 articles [95%]). CONCLUSIONS AND RELEVANCE The reporting quality of systematic reviews in plastic surgery requires improvement. Enforcement of compliance through journal submission systems, as well as improved education, awareness, and a cohesive strategy among all stakeholders, is called for. LEVEL OF EVIDENCE NA.