A biomechanical comparison of 2 hybrid techniques for elbow ulnar collateral ligament reconstruction.

PURPOSE: To compare the valgus laxity and fixation strength of 2 hybrid techniques for elbow ulnar collateral ligament reconstructions. METHODS: Reflective markers were placed near the ligament attachments of the ulnar collateral ligament on the humerus and ulna of 12 fresh-frozen cadaveric upper extremities for tracking displacement with 4 motion analysis cameras. Valgus laxity testing was performed on the intact, disrupted ligament, and reconstructed elbows by applying a 3.0 Nm moment across the joint at 15° intervals throughout elbow motion from 0° to 120°. Two hybrid techniques for ulnar collateral ligament reconstruction were performed: a proximal docking method and a single-point distal fixation method. Failure testing was performed with the elbow at 90° by applying a cyclic valgus load 12 cm distal to the joint that we increased in 10-N intervals. RESULTS: Valgus laxity testing revealed no difference in ligament displacements between the 2 techniques over the entire range of elbow motion. Ligament displacement for the proximal docking hybrid technique was significantly higher than the intact at 0° and 15° of elbow flexion. Failure testing revealed no differences in ligament displacements or failure load between the 2 techniques. CONCLUSIONS: Both the proximal docking and the single-point fixation hybrid reconstructions provided sufficient joint stability and strength compared to the intact elbows, with the exception of the proximal docking method at low flexion angles. The reconstructions were not significantly different with respect to valgus laxity or graft fixation displacement at failure. CLINICAL RELEVANCE: The proximal docking and single-point fixation hybrids tested here are both viable surgical options with sufficient strength and valgus laxity mechanics, warranting clinical evaluation.

Quality of reporting among systematic reviews underpinning the ESC/ACC guidelines on ventricular arrhythmias and sudden cardiac death.

OBJECTIVES: The main objective of this study was to assess the methodological and reporting quality of the systematic reviews (SRs) supporting the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) clinical practice guidelines (CPGs) recommendations for the management of patients with ventricular arrhythmias and sudden cardiac death (SCD). As a secondary objective, we sought to determine: (1) the proportion of Cochrane SRs were cited; and (2) whether Cochrane SRs scored higher on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) appraisals. DESIGN: Cross-sectional analysis. MAIN OUTCOME MEASURES: We searched for CPGs published by the ESC and the ACC from 2010 to 2020. We selected the CPGs for ventricular arrhythmias and the prevention of SCD. The reference sections were searched for SRs. Two independent investigators evaluated eligible SR using the PRISMA checklist and the AMSTAR-2 assessment tool. RESULTS: Two CPGs for ventricular arrhythmia and SCD were included in this study. Fifty-five SRs were included in our analysis. Across all SRs, the mean PRISMA score was 0.70. The lowest scoring PRISMA item related to the presence of a pre-published protocol (item 5, score 0.17). Overall, 40% of included SRs were found to have 'critically low' AMSTAR-2 ratings. One of the lowest scoring items for AMSTAR-2 was reporting of sources of funding (item 10). The 4 Cochrane SRs that were included scored higher on both assessment tools than non-Cochrane studies, specifically in PRISMA overall completion (88.7% vs 69.7%). CONCLUSION: Our study suggests the methodological and reporting quality of SRs used within ESC and ACC CPGs is insufficient, as demonstrated by the lack of adherence to both AMSTAR-2 and PRISMA checklists. Given the importance of CPGs on clinical decision making, and ultimately patient care, the methodological rigour and quality reporting within SRs used in CPGs should be held to the highest standard within the field of cardiology.

Examining the Public's Most Frequently Asked Questions Regarding COVID-19 Vaccines Using Search Engine Analytics in the United States: Observational Study.

BACKGROUND: The emergency authorization of COVID-19 vaccines has offered the first means of long-term protection against COVID-19-related illness since the pandemic began. It is important for health care professionals to understand commonly held COVID-19 vaccine concerns and to be equipped with quality information that can be used to assist in medical decision-making. OBJECTIVE: Using Google's RankBrain machine learning algorithm, we sought to characterize the content of the most frequently asked questions (FAQs) about COVID-19 vaccines evidenced by internet searches. Secondarily, we sought to examine the information transparency and quality of sources used by Google to answer FAQs on COVID-19 vaccines. METHODS: We searched COVID-19 vaccine terms on Google and used the "People also ask" box to obtain FAQs generated by Google's machine learning algorithms. FAQs are assigned an "answer" source by Google. We extracted FAQs and answer sources related to COVID-19 vaccines. We used the Rothwell Classification of Questions to categorize questions on the basis of content. We classified answer sources as either academic, commercial, government, media outlet, or medical practice. We used the Journal of the American Medical Association's (JAMA's) benchmark criteria to assess information transparency and Brief DISCERN to assess information quality for answer sources. FAQ and answer source type frequencies were calculated. Chi-square tests were used to determine associations between information transparency by source type. One-way analysis of variance was used to assess differences in mean Brief DISCERN scores by source type. RESULTS: Our search yielded 28 unique FAQs about COVID-19 vaccines. Most COVID-19 vaccine-related FAQs were seeking factual information (22/28, 78.6%), specifically about safety and efficacy (9/22, 40.9%). The most common source type was media outlets (12/28, 42.9%), followed by government sources (11/28, 39.3%). Nineteen sources met 3 or more JAMA benchmark criteria with government sources as the majority (10/19, 52.6%). JAMA benchmark criteria performance did not significantly differ among source types (χ 2 4=7.40; P=.12). One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores by source type (F 4,23=10.27; P<.001). CONCLUSIONS: The most frequently asked COVID-19 vaccine-related questions pertained to vaccine safety and efficacy. We found that government sources provided the most transparent and highest-quality web-based COVID-19 vaccine-related information. Recognizing common questions and concerns about COVID-19 vaccines may assist in improving vaccination efforts.

Spin in the abstracts of systematic reviews and metaanalyses focused on percutaneous coronary intervention.

CONTEXT: "Spin" is a form of bias that involves highlighting study results in a way that presents the conclusions about benefit or efficacy beyond the scope of the data. Spin in the abstract of published studies has the potential to affect patient care, making investigations about its presence and prevalence important for readers. OBJECTIVES: To evaluate the most severe types of spin in the abstracts of systematic reviews and metaanalyses focused on percutaneous coronary intervention. METHODS: Using a cross sectional study design, the authors searched MEDLINE and Embase with the terms "percutaneous coronary intervention," "percutaneous coronary revascularization," "PCI," "systematic review," "meta analysis," and "meta-analysis." To be considered for this study, the article must have (1) focused on PCI; (2) had either a systematic review or metaanalysis study design; (3) been conducted on human subjects; and (4) been available in English. Reviews were excluded if these criteria were not met. Each included article was assessed for the nine most severe types of spin as defined in a previously published article, as well as other study characteristics (type of intervention being compared, date the review was received, adherence of systematic review and/or meta-analysis to Preferred Reporting for Systematic Reviews or Metanalyses (PRISMA) guidelines, requirement of PRISMA guidelines by the publishing journal, the publishing journal's five-year impact factor, and sources of funding). RESULTS: Our database search retrieved 7,038 records; 2,190 duplicates were removed. Initial title and abstract screening led to the exclusion of 4,367 records, and an additional 281 records were excluded during full text screening. An arbitrary limit of 200 articles was applied for this analysis; five additional articles were excluded for ineligible study design, so 195 were included in our final analysis. Spin was present in the abstracts of 43 studies from that pool (22.1%). Spin type 3-selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention-occurred most frequently (29; 14.8%). The presence of spin was not associated with any of the extracted study characteristics. CONCLUSIONS: Our data showed that spin occurred in more than one in every five systematic reviews or metaanalyses of PCI. Spin has the potential to distort a reader's ability to translate the true findings of a study; therefore, efforts are needed to prevent spin from appearing in article summaries.

Evaluation of spin in the abstracts of systematic reviews and meta-analyses focused on the treatment of obesity.

OBJECTIVE: Spin, i.e., the misrepresentation of research findings, has the potential to affect patient care. Evidence suggests that spin is prevalent in obesity randomized controlled trials. Therefore, the primary objective of this study was to evaluate spin in abstracts of systematic reviews covering obesity treatments. METHODS: MEDLINE and Embase were searched to retrieve systematic reviews on obesity treatments. Each systematic review abstract was inspected for the nine most severe types of spin, i.e., the misrepresentation of study findings by exaggeration or omission, regardless of intentionality. Screening and data extraction occurred in a masked, triplicate fashion. Methodological quality was determined using A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2). RESULTS: Spin was identified in 20 (out of 200, 10%) abstracts, with spin type 5 (claiming efficacy despite high risk of bias among primary studies) being most common (11/200, 5.5%). Spin types 2 and 7, both related to unsupported efficacy claims, were not found. No associations were found between spin and extracted study characteristics. The methodological quality of the sample was rated as follows: critically low (23.0%), low (13.5%), moderate (60.5%), and high (3%). CONCLUSIONS: Although these findings demonstrate a low proportion of spin in the abstracts of systematic reviews for obesity treatment; increased preventive measures may further reduce its presence.

Do oncology researchers adhere to reproducible and transparent principles? A cross-sectional survey of published oncology literature.

OBJECTIVES: As much as 50%-90% of research is estimated to be irreproducible, costing upwards of $28 billion in USA alone. Reproducible research practices are essential to improving the reproducibility and transparency of biomedical research, such as including preregistering studies, publishing a protocol, making research data and metadata publicly available, and publishing in open access journals. Here we report an investigation of key reproducible or transparent research practices in the published oncology literature. DESIGN: We performed a cross-sectional analysis of a random sample of 300 oncology publications published from 2014 to 2018. We extracted key reproducibility and transparency characteristics in a duplicative fashion by blinded investigators using a pilot tested Google Form. PRIMARY OUTCOME MEASURES: The primary outcome of this investigation is the frequency of key reproducible or transparent research practices followed in published biomedical and clinical oncology literature. RESULTS: Of the 300 publications randomly sampled, 296 were analysed for reproducibility characteristics. Of these 296 publications, 194 contained empirical data that could be analysed for reproducible and transparent research practices. Raw data were available for nine studies (4.6%). Five publications (2.6%) provided a protocol. Despite our sample including 15 clinical trials and 7 systematic reviews/meta-analyses, only 7 included a preregistration statement. Less than 25% (65/194) of publications provided an author conflict of interest statement. CONCLUSION: We found that key reproducibility and transparency characteristics were absent from a random sample of published oncology publications. We recommend required preregistration for all eligible trials and systematic reviews, published protocols for all manuscripts, and deposition of raw data and metadata in public repositories.

How Fragile Are Clinical Trial Outcomes That Support the CHEST Clinical Practice Guidelines for VTE?

BACKGROUND: VTE remains a health concern for global populations. Clinical practice guidelines are necessary to guide physicians in the prophylaxis and treatment of VTE. METHODS: Our investigation assessed the robustness of the underlying evidence in 21 randomized controlled trials (RCTs) used to support treatment recommendations in the 2016 update of the CHEST Guideline and Expert Panel Report on Antithrombotic Therapy for VTE Disease. We calculated the fragility index and fragility quotient for qualifying outcomes within RCTs. RESULTS: The median fragility index for all studies was 5 (interquartile range, 1-9), with a median fragility quotient of 0.012 (interquartile range, 0.002-0.032). CONCLUSIONS: Our conclusions parallel those of previous investigations of the fragility of RCT outcomes; we found that some outcomes used to support recommendations in AT10 are fragile. We recommend that the fragility index and fragility quotient be adopted as measures of robustness of clinical trial outcomes.

Biomechanical Comparison of Ulnar Collateral Ligament Repair With Internal Bracing Versus Modified Jobe Reconstruction.

BACKGROUND: The number of throwing athletes with ulnar collateral ligament (UCL) injuries has increased recently, with a seemingly exponential increase of such injuries in adolescents. In cases of acute proximal or distal UCL insertion injuries or in partial-thickness injuries that do not respond to nonoperative management, UCL repair and augmentation rather than reconstruction may be a viable option. PURPOSE/HYPOTHESIS: The purpose of this study was to biomechanically compare a new technique of augmented UCL repair versus a typical modified Jobe UCL reconstruction technique. The hypotheses were that (1) the repaired specimens would have less gap formation and a higher maximal torque to failure compared with the reconstruction group, and (2) while both groups would show an increase in gap formation after the simulated tear, the repair group would return closer to the native values compared with the reconstruction group. STUDY DESIGN: Controlled laboratory study. METHODS: Nine matched pairs of cadaveric arms were dissected to expose the UCL. Each elbow was mounted on a test frame at 90° of flexion. A cyclic valgus rotational torque was applied to the humerus with the UCL in its intact state and repeated in its surgically torn state. Finally, each specimen received either an augmented repair or reconstruction and was again put through the cyclic protocol, followed by a torque to failure. RESULTS: Gap formation (0.51 ± 0.22 mm) in the torn state for the repair group was significantly higher (P = .04) than in the intact state (0.33 ± 0.12 mm). After the procedures, the repair group (0.35 ± 0.16 mm) showed greater resistance to gapping (P = .03) compared with the reconstruction group (0.53 ± 0.23 mm). No statistical differences were found for the maximum torque at failure, torsional stiffness, or gap formation during the failure test. CONCLUSION: The current study shows that this novel technique of augmented UCL repair replicates the time-zero failure strength of traditional graft reconstruction and appears to be more resistant to gapping at low cyclic loads. CLINICAL RELEVANCE: This study demonstrates that this novel technique has important biomechanical properties, including time-zero strength and ultimate failure load, compared with the gold standard of UCL reconstruction. In some throwing athletes, this technique may supplant standard UCL reconstruction as the procedure of choice.

Ulnar collateral ligament in the overhead athlete: a current review.

Ulnar collateral ligament (UCL) injuries are most commonly reported in baseball players (particularly in pitchers) but have also been observed in other overhead athletes including javelin, softball, tennis, volleyball, water polo, and gymnastics. Partial injuries have been successfully treated with appropriate nonoperative measures but complete tears and chronic injuries have shown less benefit from conservative measures. In these cases, surgical reconstruction has become the treatment modality for overhead athlete who wishes to continue to play. This article discusses the functional anatomy and biomechanics of the UCL as related to the pathophysiology of overhead throwing, as well as the important clinical methods needed to make accurate and timely diagnosis. It also gives an updated review of the current clinical outcomes and complications of surgical reconstruction.