Achilleas Thoma

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.

Randomized Controlled Trials of Surgical Interventions

Background and Objectives:Surgical trials pose many methodological challenges often not present in trials of medical interventions. If not properly accounted for, these challenges may introduce significant biases and threaten the validity of the results. Methods:We systematically reviewed the significance of randomized controlled trials in the evaluation of surgical interventions, discussed the methodological challenges encountered in designing and conducting randomized controlled trials of surgical treatments, and proposed possible solutions to overcome these challenges. Conclusions:Many barriers and issues of surgical trials affecting internal validity can be overcome with proper methodology, and in most cases these issues do not restrict their conduct. Researchers should consider their research question carefully and design a surgical trial that contains features appropriate for the question. In doing so, they must ensure that the trial is valid, feasible, and affordable—a difficult feat, but one well worth the challenge.

A meta-analysis of randomized controlled trials comparing endoscopic and open carpal tunnel decompression.

Controversy exists regarding the benefit of endoscopic carpal tunnel release versus open carpal tunnel release in terms of grip/pinch strength, scar tenderness, pain, return to work, reversible/irreversible nerve damage, and adverse effects. Although a number of randomized controlled trials and systematic reviews have been published on the subject, to date, no large definitive randomized controlled trial or meta-analysis has been performed comparing endoscopic to open carpal tunnel release. This meta-analysis was undertaken to address the effectiveness of endoscopic carpal tunnel release relative to open carpal tunnel release. Key outcome measures from 13 randomized controlled trials were extracted and statistically combined. Heterogeneity was observed in three of the outcomes (i.e., grip strength, pain, and return to work), but the causes of heterogeneity could not be explained because of insufficient detail in the reported studies. Using the Jadad et al. scale, nine of 13 studies were of low methodologic quality. The effect sizes were compared between the studies that were rated as high quality and the studies that were rated as low quality on the Jadad et al. scale. Similarly, the studies that were rated as high quality on the Gerritsen et al. scale were compared with those that were rated as low quality. No clinically significant difference in effect sizes was apparent between studies of high and low methodologic quality. This meta-analysis supports the conclusion that endoscopic carpal tunnel release is favored over the open carpal tunnel release in terms of a reduction in scar tenderness and increase in grip and pinch strength at a 12-week follow-up. With regard to symptom relief and return to work, the data are inconclusive. Irreversible nerve damage is uncommon in either technique; however, there is an increased susceptibility to reversible nerve injury that is three times as likely to occur with endoscopic carpal tunnel release than with open carpal tunnel release.

Systematic review of skin graft donor-site dressings.

Background: Debate continues about what split-thickness skin graft donor-site dressing provides the best outcomes for patients at the lowest cost. The goal of this systematic review was to determine which donor-site dressings are associated with the best outcomes for the following: pain, infection rate, healing quality, healing rate, quality of life, and cost. Methods: A comprehensive literature review and assessment was undertaken by two independent reviewers. Articles were selected using specific inclusion criteria. Split-thickness skin graft donor-site dressings were classified as either moist or nonmoist based on the state of the dressing upon initial application. Methodological quality of randomized controlled trials was assessed using the Jadad scale. Results: Seventy-five relevant articles were included in the final analysis, three of which were review articles. The most commonly measured outcome was healing rate (64 of 72), followed by pain (58 of 72), infection rate (40 of 72), healing quality (40 of 72), and cost (15 of 72). No studies measured quality of life. The majority of articles were randomized controlled trials (35 of 75), followed by observational studies (22 of 75), unsystematic clinical observations (15 of 75), and review articles (three of 75). It was difficult to compare moist and nonmoist dressings in this review because of the methodological heterogeneity of the included articles. The available evidence suggests, however, that moist dressings are superior in terms of pain. Conclusions: Some weak evidence exists that supports “wet dressings.” To determine the best split-thickness skin graft donor-site dressing, more methodologically sound randomized controlled trials are needed. Trials with parallel economic evaluations should be undertaken to answer this question.

A prospective study of patients undergoing breast reduction surgery: health-related quality of life and clinical outcomes.

Background: This study assessed the health-related quality of life experienced by breast reduction patients using four reliable and validated health-related quality-of-life measures. Methods: Consecutive patients with breast hypertrophy completed the Health Utilities Index Mark 2, the Health Utilities Index Mark 3, and the Breast Reduction Assessment Value and Outcomes instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire Appearance Assessment, and the Breast-Related Symptom Questionnaire) at 1 week and 1 day before surgery and at 1, 6, and 12 months after surgery. Results: For the 52 patients in the study, mean scores for all quality-of-life instruments increased from the preoperative assessments to the postoperative assessments. The mean quality-adjusted life years gained per patient because of the surgery was 0.12 during the 1-year follow-up period. There was a positive relationship (p < 0.001) between breast resection weight and body mass index. However, body mass index and tissue resection weight were not significantly associated with Health Utilities Index Mark 3 change scores (p > 0.05). Conclusions: Patients who undergo breast reduction experience an important improvement in health-related quality of life according to four established measures. The improvement is most noticeable between 1 day before surgery and 1 month after surgery, after which it stabilizes for up to 1 year. The health-related quality-of-life effect of the surgery translates into an expected lifetime gain of 5.32 quality-adjusted life years, which is equivalent to each patient living an additional 5.32 years in perfect health. The authors conclude that there is no justification for the ongoing restriction or denials of third-party payments based on body mass index.

Systematic review of flexor tendon rehabilitation protocols in zone II of the hand.

Background: Restoration of function following flexor tendon repair in zone II represents a difficult clinical problem. Despite many publications on rehabilitation methods, there exists no consensus as to which method is superior. This study was undertaken to determine which flexor tendon rehabilitation protocol provides the best outcome after surgical repair in zone II. Methods: Electronic databases were searched for articles published between 1970 and 2009. The population included patients aged 5 years and older who sustained a flexor tendon laceration in zone II. The primary outcome was rupture rate. Secondary outcomes were range of motion and quality of life. The following protocols and their variations were considered: passive flexion and active extension protocols (Kleinert type protocols), controlled passive motion protocols (Duran type protocols), combination of the Kleinert and Duran protocols, and early active motion protocols. Results: Seventy-nine articles were identified. Fifteen studies met the inclusion criteria. The mean rate of rupture was lowest in the combined Kleinert and Duran protocols (2.3 percent) and highest in the Kleinert protocols (7.1 percent). No statistically significant differences were found. The combined Kleinert and Duran protocols and the early active motion protocols exhibited the highest proportion of digits with excellent or good results using the Strickland and Buck-Gramcko systems. One study included a quality-of-life assessment—meaningful comparison was not possible. Conclusions: Both early active motion protocols and combined Kleinert and Duran protocols result in low rates of tendon rupture and acceptable range of motion following flexor tendon repair in zone II. Future studies should include quality-of-life measurements using validated scales.

Decompression of the common peroneal nerve: experience with 20 consecutive cases.

A retrospective review of 20 patients with common peroneal nerve palsy treated with decompression between 1986 and 1997 was undertaken. Subjects were evaluated preoperatively and postoperatively by electromyography, nerve conduction, and clinical measures. The mean interval between the onset of symptoms to surgery (operative delay) was 15.9 months. The mean postoperative follow‐up was 32.2 months with a minimum follow‐up of 1 year. Decompression was performed at the level of the fibular neck and slightly distally at the tendinous origin of the peroneus longus using a standard approach to release tight fascial structures or scar tissue. External neurolysis was performed using the operating microscope in two cases for which scarring of the nerve was identified intraoperatively. Postoperatively, 19 of 20 patients showed improvement in ankle dorsiflexion as assessed by the Medical Research Council scale. Electromyographic examination was useful in the preoperative evaluation and selection of patients for decompression surgery. In conclusion, decompression even after a 1‐year delay may offer benefit and suggest early intervention in patients with a severe lesion. (Plast. Reconstr. Surg. 107: 1183, 2001.)

Optimal Time Delay between Epinephrine Injection and Incision to Minimize Bleeding

Background: The time until maximal cutaneous vasoconstriction after injection of lidocaine with epinephrine is often given in textbooks and multiple choice examinations as 7 to 10 minutes. However, in our experience, there is significantly less cutaneous bleeding if one waits considerably longer than 7 to 10 minutes after injection of local anesthesia with epinephrine for most procedures on human skin. Methods: This was a prospective, randomized, triple-blind study where 12 volunteers were injected simultaneously in each arm with either 1% lidocaine with epinephrine (study group) or 1% plain lidocaine (control group), after which the relative hemoglobin concentration of the underlying skin and soft tissues was measured over time using spectroscopy. Results: In the epinephrine group, the mean time at which the lowest cutaneous hemoglobin level was obtained was 25.9 minutes (95 percent CI, 25.9 ± 5.1 minutes). This was significantly longer than the historical literature values of 7 to 10 minutes for maximum vasoconstriction after injection. Mean hemoglobin index values at every time measurement after postinjection minute 1 were significantly different between the study group and the control group, with use of a two-tailed paired t test (p < 0.01). Conclusions: If optimal visualization is desired, the ideal time for the surgeon to begin the incision should be 25 minutes after injection of local anesthetic with epinephrine. It takes considerably longer than 7 to 10 minutes for a new local equilibrium to be obtained in relation to hemoglobin quantity. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.