Regional Wait Times for Patients With Nonmelanoma Skin Cancer in Southwestern Ontario.

BACKGROUND: Nonmelanoma skin cancer (NMSC) affects many Canadians. Although morbidity and mortality are rare, the burden to patients and the health-care system is significant. This study aims to evaluate current plastic surgery wait times and care pathways for patients with NMSC in Southwestern Ontario. METHODS: A retrospective chart review of 225 patients treated in Ontario from 2015 to 2018 was conducted. Inclusion criteria included patients with an NMSC managed with surgical excision. Referral information was compared. Primary outcomes were wait times: from referral to consultation, referral to excision, and consultation to excision. Data were analyzed using Student t test with equal variance. RESULTS: One-hundred forty-three patients were included from the academic cohort and 82 from the community cohort. Referrals to academic and community surgeons included lesion location (90% and 97.6%, respectively), but less frequently included size (18% and 29.2%, respectively). Most referrals to academic surgeons included biopsy results (78.6%), as opposed to community referrals (25.6%). Patients in the academic cohort waited 15.3 ± 12.7 weeks from referral to consultation, and 15.7 ± 13 weeks from referral to excision. Patients from the community cohort waited significantly shorter periods of 4.9 ± 3.1 (P < .001) and 11.7 ± 9.9 weeks (P = .016), respectively. However, patients of the academic cohort waited 2.4 ± 7.1 weeks from consultation to excision, while patients in the community cohort waited 6.7 ± 9.6 weeks (P < .001). Rates of negative peripheral margins on pathology were similar between groups, at 89.5% of the academic cohort and 88.9% of the community cohort. Deep margins were positive 5.7% of the time at the academic sites and 6.2% of the time in the community. CONCLUSIONS: Patients referred to academic centres waited significantly longer periods of time in several parameters compared to those referred to a community surgeon. However, academic surgeons often had expedited consultation-to-excision time frame. This study provides important data for future quality improvement initiatives in NMSC care.

HISTORIQUE: De nombreux Canadiens ont un cancer cutané non mélanome (CCNM). Bien que la morbidité et la mortalité soient rares, le fardeau est important pour les patients et le système de santé. La présente étude a été conçue pour évaluer les temps d'attente et les trajectoires de soins en chirurgie plastique pour les patients du sud-ouest de l'Ontario ayant un CCNM. MÉTHODOLOGIE: Les chercheurs ont réalisé une analyse rétrospective des dossiers de 225 patients traités de 2015 à 2018 en Ontario. Un CCNM traité par excision chirurgicale faisait partie des critères d'inclusion. Les chercheurs ont comparé les données d'adressage vers la chirurgie. Les résultats cliniques primaires étaient les temps d'attente entre l'adressage et la consultation, entre l'adressage et l'excision ainsi qu'entre la consultation et l'excision. Les chercheurs ont analysé les données au moyen du test de Student de variance égale. RÉSULTATS: Au total, 143 patients ont fait partie de la cohorte universitaire et 82, de la cohorte communautaire. L'adressage vers des chirurgiens universitaires ou communautaires découlait du siège de la lésion (90 % et 97,6 %, respectivement) et, à une moindre fréquence, de sa dimension (18,6 % et 29,2 %, respectivement). La plupart des adressages vers des chirurgiens universitaires incluaient les résultats de biopsies (78,6 %), contrairement à celui vers des chirurgiens communautaires (25,6 %). Les patients de la cohorte universitaire ont attendu 15,3 ± 12,7 semaines entre l'adressage et la consultation, et 15,7 ± 13 semaines entre l'adressage et l'excision. Les patients de la cohorte communautaire ont attendu beaucoup moins longtemps, soit 4,9 ± 3,1 (P < 0,001) et 11,7 ± 9,9 semaines (P = 0,016), respectivement. Cependant, les patients de la cohorte universitaire ont attendu 2,4 ± 7,1 semaines entre la consultation et l'excision, et ceux de la cohorte communautaire, 6,7 ± 9,6 semaines (P < 0,001). À la pathologie, le taux de marges périphériques négatives était semblable entre les groupes, se situant à 89,5 % dans la cohorte universitaire et à 88,9 % dans la cohorte communautaire. Les marges profondes étaient positives dans 5,7 % des cas en milieu universitaire et dans 6,2 % des cas dans la communauté. CONCLUSIONS: Les patients adressés à des centres universitaires attendaient considérablement plus longtemps à l'égard de plusieurs paramètres par rapport à ceux adressés à un chirurgien communautaire. Cependant, les chirurgiens universitaires réduisaient souvent la période entre la consultation et l'excision. La présente étude fournit des données importantes en vue de prochaines initiatives d'amélioration de la qualité des soins du CCNM.

Arthroscopic versus open excision of dorsal ganglion cysts: a systematic review.

We conducted a systematic review comparing recurrence and complication rate following open versus arthroscopic excision of ganglion cysts. Sixteen full-text articles were included. The pooled recurrence rate of open excision was 20% (range: 5.6-40.7%) with Q value of 27 and I2 of 82%. The pooled recurrence rate of arthroscopic excision was 9% (range: 0-17%) with Q value of 10 and I2 of 2%. Eleven of 16 studies were low quality or had a high risk of bias; however, excluding low quality studies or those with high risk of bias produced similar recurrence rates in arthroscopic and open excision (7.9% versus 9.8%). For the subset of studies with complete reporting of complications, rates were similar in open and arthroscopic excision (6% versus 4%). Our review suggests that arthroscopic and open approaches have comparable outcome profiles. Nevertheless, standardized study methods with adequate powering are required to collect high quality data, allowing for greater confidence in conclusions regarding these two approaches for existing ganglion cysts. LEVEL OF EVIDENCE: II.

Proximal Pole Scaphoid Fractures: A Computed Tomographic Assessment of Outcomes.

PURPOSE: To report on union rates and times for a cohort of acute nondisplaced or minimally displaced proximal pole fractures evaluated with serial computed tomography (CT) scans. METHODS: All patients with isolated acute proximal pole scaphoid fractures (< 6 weeks from injury) who presented at our institution between 2006 and 2013 were identified. Each subject's health record, CT scans (performed at initial assessment and serially to document healing), and x-rays were retrospectively reviewed to determine details of injury, treatment course, and treatment outcome. Union incidence and time to union were determined based on CT scan results. The effect that each predictor variable had on union, nonunion, and delayed union was assessed. RESULTS: This cohort consisted of 53 patients with proximal pole scaphoid fractures (47 males and 6 females; mean age, 30 ± 17 years). The overall union incidence with cast treatment was 90% (47 of 52). The study was underpowered to detect any factors that were predictive of developing a nonunion with cast treatment with the exception of a slight delay to seeking treatment. Average time to union was 14 ± 8 weeks for cases treated with surgical fixation (n = 4; cases that failed casting and were subsequently treated surgically) and 14 ± 12 weeks for cases treated with casting alone. Factors found to be correlated to longer union times included fracture translation (r = 0.30) and the presence of cysts or comminution. CONCLUSIONS: The reported union incidence and union times in this study compared favorably with the literature. Risk factors that were associated with a significantly greater time to union included fracture comminution, the presence of cysts, and fracture translation. Our sample size was relatively small, and other limitations inherent in the retrospective design must be considered. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

Management of complications of extensor tendon injuries.

Treatment goals for the management of extensor tendon injuries include restoration of function, minimizing disability, and decreasing the risk of complications. These goals can be achieved with an accurate understanding of the zone-specific concerns for extensor tendon injuries, early referral to hand therapy, and active communication between hand surgeons and therapists. This article reviews extensor tendon injuries by zone, outlines optimal management strategies that help prevent complications, and describes the treatment of these complications.

From time-based to competency-based standards: core transitional competencies in plastic surgery.

PURPOSE: Competency-based medical education is becoming increasingly prevalent and is likely to be mandated by the Royal College in the near future. The objective of this study was to define the core technical competencies that should be possessed by plastic surgery residents as they transition into their senior (presently postgraduate year 3) years of training. METHODS: A list of potential core competencies was generated using a modified Delphi method that included the investigators and 6 experienced, academic plastic surgeons from across Canada and the United States. Generated items were divided into 7 domains: basic surgical skills, anesthesia, hand surgery, cutaneous surgery, esthetic surgery, breast surgery, and craniofacial surgery. Members of the Delphi group were asked to rank particular skills on a 4-point scale with anchored descriptors. Item reduction resulted in a survey consisting of 48 skills grouped into the aforementioned domains. This self-administered survey was distributed to all Canadian program directors (n = 11) via e-mail for validation and further item reduction. RESULTS: The response rate was 100% (11/11). Using the average rankings of program directors, 26 "core" skills were identified. There was agreement of core skills across all domains except for breast surgery and esthetic surgery. Of them, 7 skills were determined to be above the level of a trainee at this stage; a further 15 skills were agreed to be important, but not core, competencies. CONCLUSIONS: Overall, 26 competencies have been identified as "core" for plastic surgery residents to possess as they begin their senior, on-service years. The nature of these skills makes them suitable for teaching in a formal, simulated environment, which would ensure that all plastic surgery trainees are competent in these tasks as they transition to their senior years of residency.

Current biopsy practices for suspected melanoma: A survey of family physicians in Southwestern Ontario.

BACKGROUND: Family physicians (FPs) have an opportunity to diagnose pigmented lesions early with a timely biopsy. OBJECTIVE: To assess current biopsy practices used by FPs in diagnosing melanoma. METHODS: A computer-generated random sample of 200 practicing FPs from large and small communities in Southwestern Ontario was identified from the College of Physicians and Surgeons of Ontario physician directory. Paper-based surveys exploring practice setting, basic melanoma knowledge, biopsy practices and referral wait times were mailed using a modified Dillman protocol. RESULTS: The response rate was 50% and respondents reflected the demographic characteristics of FPs nationwide as per the National Physician Survey. Knowledge testing revealed reasonable mean (± SD) scores (3.2±1.03 of 5). Twenty percent of respondents would always perform an excisional biopsy of skin lesions suspicious for melanoma. The remaining 80% would avoid an excisional biopsy in an aesthetically sensitive area and if there was risk of failure to close the defect primarily, among other reasons. If an excisional biopsy were not performed, one-half of respondents would perform an incisional biopsy (eg, punch biopsy). In large communities, 24% of patients were not seen by a surgeon within six months when referred without a tissue biopsy, leading to delayed diagnosis. DISCUSSION: Educating and supporting FPs to perform incisional biopsies in cases for which excisional biopsies are inappropriate should result in earlier diagnosis of melanoma. CONCLUSION: FPs appropriately recognize that excisional biopsies are ideal in melanoma management and one-half will move on to an incisional biopsy when excision is not appropriate.

HISTORIQUE: Les médecins de famille (M) peuvent diagnostiquer des lésions pigmentées rapidement grâce à une biopsie. OBJECTIF: Évaluer les pratiques de biopsie actuelles des MF pour diagnostiquer un mélanome. MÉTHODOLOGIE: Un échantillon aléatoire créé par ordinateur de 200 MF en exercice de grandes et petites collectivités du sud-ouest de l'Ontario a été extrait du répertoire de l'Ordre des médecins et chirurgiens de l'Ontario. On leur a posté des sondages papier au sujet de leur lieu de pratique, de leurs connaissances de base sur les mélanomes, de leurs pratiques de biopsie et des temps d'attente avant l'aiguillage, selon un protocole de Dillman modifié. RÉSULTATS: Le taux de réponse s'élevait à 50 % et les répondants reflétaient les caractéristiques démographiques des MF au pays, conformément au Sondage national des médecins. Les tests sur les connaissances ont révélé des indices moyens (± ÉT) raisonnables (3,2±1,03 sur 5). Vingt pour cent des répondants effectueraient toujours une biopsie-exérèse des lésions cutanées en cas de présomption de mélanome. Les 80 % restants éviteraient une biopsie-exérèse dans une zone esthétiquement fragile et en présence d'un risque de ne pas fermer l'anomalie primaire, entre autres. S'ils rejetaient la biopsie-exérèse, la moitié des répondants effectueraient une biopsie incisionnelle (p. ex., biopsie à l'emporte-pièce). Dans les grandes collectivités, 24 % des patients n'étaient pas vus par un chirurgien dans les six mois s'ils étaient aiguillés sans biopsie des tissus, ce qui s'associait à un retard de diagnostic. EXPOSÉ: L'enseignement et le soutien des MF à effectuer une biopsie incisionnelle lorsque la biopsie-exérèse ne convient pas devraient favoriser un diagnostic plus rapide des mélanomes. CONCLUSION: Le MF indiquait correctement que les biopsies-exérèses sont idéales pour prendre en charge les mélanomes et la moitié opterait pour une biopsie incisionnelle lorsque l'excision ne convient pas.

Complications associated with operative versus nonsurgical treatment of distal radius fractures in patients aged 65 years and older.

PURPOSE: To compare complication rates for distal radius fractures treated operatively versus nonsurgical in patients older than 65 years. We hypothesized that surgical intervention would improve fracture alignment, but it would be associated with more complications and equivalent functional outcomes when compared with the nonsurgical group. METHODS: Patients (operative, n = 129) and controls (nonsurgical, n = 129) were identified from a prospective clinical and operating room database. They were matched on fracture severity (AO-A/B/C1 vs AO-C2/C3), sex, age, and energy of injury. Data on complications were extracted from medical charts using a validated complications checklist, and radiologic data were collected for all patients. Functional outcomes (Patient-Related Wrist Evaluation) at 1 year were available in only a subset of patients. We determined differences in complication and reoperation rates using a chi-square test. RESULTS: A significant number of patients experienced complications in the operative group (operative = 37 of 129; nonsurgical = 22 of 129). The most common complication was median neuropathy (n = 8 operative; n = 14 nonsurgical), followed by surgical site infections (n = 16 operative; 12 of 16 were pin site infections) and complex regional pain syndrome (n = 4 operative; 3 nonsurgical). The complication rate in patients treated with volar plate was 22% (16 of 74), for dorsal plate it was 50% (2 of 4), for external fixation it was 42% (16 of 38), and for percutaneous pinning it was 23% (3 of 13). The number of patients requiring reoperations was similar in both groups (11 [9%] operative; 7 [5%] nonsurgical). Our secondary radiologic and functional outcomes demonstrate that despite a higher incidence of malunion in nonsurgical patients (nonsurgical: 69% vs operative: 29%), a subset of patients from both groups (n = 140) had minimal pain and disability at 1 year (Patient-Related Wrist Evaluation operative: 16.9 ± 23.2; nonsurgical: 15.7 ± 17.5). CONCLUSIONS: In a study matching fracture severity, sex, age, and energy of injury, we found that elderly patients with distal radius fractures who underwent surgery had higher complication rates than those treated nonsurgically. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic III.

Incidental Internal Mammary Nodes during Recipient Vessel Dissection in Breast Reconstruction: Are They Significant?

SUMMARY: Internal mammary (IM) lymph nodes may be exposed during recipient vessel preparation in free-flap breast reconstruction, and in rare cases, positivity of these nodes may affect treatment in patients with breast cancer. This systematic review examines the incidence and significance of IM nodes identified by plastic surgeons. Eligibility criteria included free-flap breast reconstruction with concurrent IM node biopsy. Data were analyzed for incidence of IM node biopsy and nodal positivity. Ten studies met inclusion criteria, with a total of 2055 patients and 717 nodes submitted to pathology. Incidence of IM positivity ranged approximately from 1% to 11%, for a calculated gross overall incidence of 2.9%. Of 59 patients with a positive IM node, 50 patients received additional adjuvant therapy, with insufficient data to determine the effect of treatment on survival.

Research ethics board approval for an international thromboprophylaxis trial.

BACKGROUND: Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. METHODS: We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). RESULTS: Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. CONCLUSIONS: More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards.

Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis.

CONTEXT: Theory and simulation suggest that randomized controlled trials (RCTs) stopped early for benefit (truncated RCTs) systematically overestimate treatment effects for the outcome that precipitated early stopping. OBJECTIVE: To compare the treatment effect from truncated RCTs with that from meta-analyses of RCTs addressing the same question but not stopped early (nontruncated RCTs) and to explore factors associated with overestimates of effect. DATA SOURCES: Search of MEDLINE, EMBASE, Current Contents, and full-text journal content databases to identify truncated RCTs up to January 2007; search of MEDLINE, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effects to identify systematic reviews from which individual RCTs were extracted up to January 2008. STUDY SELECTION: Selected studies were RCTs reported as having stopped early for benefit and matching nontruncated RCTs from systematic reviews. Independent reviewers with medical content expertise, working blinded to trial results, judged the eligibility of the nontruncated RCTs based on their similarity to the truncated RCTs. DATA EXTRACTION: Reviewers with methodological expertise conducted data extraction independently. RESULTS: The analysis included 91 truncated RCTs asking 63 different questions and 424 matching nontruncated RCTs. The pooled ratio of relative risks in truncated RCTs vs matching nontruncated RCTs was 0.71 (95% confidence interval, 0.65-0.77). This difference was independent of the presence of a statistical stopping rule and the methodological quality of the studies as assessed by allocation concealment and blinding. Large differences in treatment effect size between truncated and nontruncated RCTs (ratio of relative risks <0.75) occurred with truncated RCTs having fewer than 500 events. In 39 of the 63 questions (62%), the pooled effects of the nontruncated RCTs failed to demonstrate significant benefit. CONCLUSIONS: Truncated RCTs were associated with greater effect sizes than RCTs not stopped early. This difference was independent of the presence of statistical stopping rules and was greatest in smaller studies.

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2).

BACKGROUND: Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. METHODS/DESIGN: We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation.Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed biases. DISCUSSION: A better understanding of the extent to which tRCTs exaggerate treatment effects and of the factors associated with the magnitude of this bias can optimize trial design and data monitoring charters, and may aid in the interpretation of the results from trials stopped early for benefit.

Thromboprophylaxis for hospitalized medical patients: a multicenter qualitative study.

BACKGROUND: Observational studies have documented that medical patients infrequently receive venous thromboembolism (VTE) prevention. OBJECTIVE: To understand the barriers to, and facilitators of, optimal thromboprophylaxis. PATIENTS: Hospitalized medical patients. DESIGN: We conducted in-depth interviews with 15 nurses, 6 pharmacists, 12 physicians with both clinical and managerial experience, and 3 hospital administrators. SETTING: One university-affiliated and 2 community hospitals. INTERVENTION: Interviews were audiotaped and transcribed verbatim. Transcripts were reviewed and interpreted independently in duplicate. MEASUREMENT: Analysis was conducted using grounded theory. RESULTS: Physicians and pharmacists affirmed that evidence supporting heparin is strong and understood. Clinicians, particularly nurses, reported that mobilization was important, but were uncertain about how much mobilization was enough. Participants believed that depending on individual physicians for VTE prevention is insufficient. The central finding was that multidisciplinary care was also perceived as a barrier to effective VTE prevention because it can lead to unclear accountability by role confusion. Participants believed that a comprehensive, systems approach was necessary. Suggestions included screening and risk-stratifying all patients, preprinted orders at hospital admission that are regularly reevaluated, and audit and feedback programs. Patient or family-mediated reminders, and administrative interventions, such as hiring more physiotherapists and profiling thromboprophylaxis in hospital accreditation, were also endorsed. CONCLUSIONS: Universal consideration of thromboprophylaxis finds common ground in multidisciplinary care. However, results of this qualitative study challenge the conviction that either individual physician efforts or multidisciplinary care are sufficient for optimal prevention. To ensure exemplary medical thromboprophylaxis, clinicians regarded coordinated, systemwide processes, aimed at patients, providers, and administrators as essential.

Complementary and alternative medicine use in patients with fractures.

Complementary and alternative medicine (CAM) encompasses dietary supplements, herbs, homeopathic medicines, and other modalities. In light of prevalent CAM use, patient interest, increasing CAM expenditures, and possible interactions with traditional treatments or healing we identified the following in patients with fractures: prevalence of CAM use, the amount of money patients are spending on CAMs, and the number of patients who disclose CAM use to their orthopaedic surgeon and the reasons for withholding disclosure. Factors associated with CAM use were evaluated. Of the 322 patients with fractures surveyed, 35% were using CAMs. Of the patients using CAMs, 50% spent more than $25 per month. Fifty-five percent of the patients using CAMs had not discussed their CAM use with their orthopaedic surgeon citing "it was not an important issue to discuss." Factors associated with CAM use included level of education (odds ratio, 2.5; 95% confidence interval, 1.4-4.7) and psychiatric disorders (odds ratio, 2.5; 95% confidence interval, 1.3-5.0). To avoid possible interactions with traditional treatments and to identify side effects, surgeons should ask patients with fractures about CAM use in an unbiased fashion, as most patients will not voluntarily disclose their use.

Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

BACKGROUND: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. METHODS: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003-2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. RESULTS: We found that only the Journal of Bone and Joint Surgery - American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p > 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC = 0.80, 95% CI:0.60 to 0.90). CONCLUSION: Our findings suggest that readers should not assume that 1) studies labelled as Level I have high reporting quality and 2) Level I studies have better reporting quality than Level II studies. One should address methodological safeguards individually.