The associations between social determinants of health, mental health, substance-use and recidivism: a ten-year retrospective cohort analysis of women who completed the connections programme in Australia.

BACKGROUND: Women with substance-use issues are overrepresented in prison. Research on women's recidivism often focuses on offending behaviour rather than the health and social circumstances women are experiencing when reimprisonment occurs. This study examines the relationship between social determinants of health (SDOH), mental health, substance-use and recidivism among women exiting prison with histories of substance-use. METHODS: A retrospective cohort study of women exiting prison who completed the transitional support programme "Connections" between 2008 and 2018. Recidivism was measured up to two years post-release. Women's support needs were measured at baseline (4 weeks pre-release) and follow-up (four weeks post-release). Ongoing needs in relation to well-established SDOH were calculated if: (1) at baseline women were identified as having a re-entry need with housing, employment, finances, education, domestic violence, child-custody and social support and (2) at follow-up women reported still needing help in that area. Women's self-reported substance-use and mental health since release were captured at follow-up. Descriptive statistics were calculated for all measures. Associations between SDOH, mental health, substance-use and recidivism were estimated by multiple logistic regression, adjusting for potential confounders. We also evaluated the mediating effects of mental health on the relationship between SDOH and substance-use. RESULTS: Substance-use was associated with increased odds of recidivism (adjusted odds ratio (AOR) 1.8, 95% confidence interval (CI) 1.1-2.9; p = 0.02). Poor mental health (AOR 2.9, 95% CI 1.9-4.6; p = < 0.01), ongoing social support (AOR 3.0, 95% CI 1.9-5.0; p = < 0.01), child-custody (AOR 1.9, 95% CI 1.0-3.3 p = 0.04), financial (AOR 2.0, 95% CI 1.3-3.2; p = < 0.01) and housing (AOR 1.8, 95% CI 1.1-2.9; p = 0.02) needs were individually associated with increased odds of substance-use. Mediation analysis found mental health fully mediated the effects of ongoing housing (beta efficiency (b) = - 033, standard error (SE) 0.01; p = 0.05), financial (b = 0.15, SE 0.07; p = 0.05), child-custody (b = 0.18, SE 0.01; p = 0.05) and social support (b = 0.36, SE 0.1; p = 0.05) needs onto substance-use, and partially mediated the effects of domestic violence (b = 0.57, SE 0.23; p = 0.05) onto substance-use. CONCLUSION: This study underscores the critical importance of addressing the interplay between SDOH, mental health, substance-use and recidivism. An approach that targets SDOH holds the potential for reducing mental distress and substance-use, and related recidivism.

Clinical Significance of Postoperative Atrial Fibrillation in Hypertrophic Cardiomyopathy Patients Undergoing Septal Myectomy.

BACKGROUND: The optimal management of hypertrophic cardiomyopathy (HCM) patients with postoperative atrial fibrillation (POAF) after surgical myectomy remains unknown. We sought to investigate the association between POAF and atrial fibrillation (AF) or cardioembolic events during follow-up to bridge this gap. METHODS: Patients undergoing surgical myectomy at 2 HCM referral centres in North America from 2002 to 2020 were included in this study. Patients with preoperative AF were excluded. POAF was defined as any episode of AF within 30 days after surgery. RESULTS: Of 1176 patients, 375 (31.9%) had POAF. Age (adjusted hazard ratio [HR] 1.05, 95% confidence interval [CI] 1.03-1.06; P < 0.001), premyectomy left atrial diameter (LAD; adjusted HR 1.6, 95% CI 1.32-2.02; P < 0.001), and smoking (adjusted HR 1.60, 95% CI 1.17-2.20; P = 0.001) were associated with POAF on multivariable analysis. Of 934 patients with follow-up data, of duration 4.3 ± 4.1 years, AF was detected in 86 (9.2%). Only POAF (HR 4.20, 95% CI 2.44-7.23; P < 0.001), previous history of stroke (HR 4.81, 95% CI 1.63-14.17; P = 0.01), and postmyectomy LAD (HR 1.80, 95% CI 1.21-2.70; P = 0.004) were associated with AF incidence during follow-up. Cardioembolic events occurred in only 15 patients (1.6%). POAF was not associated with increased cardioembolic risk, with only 3 patients with POAF suffering such an event, all more than 4 years after surgery. CONCLUSIONS: POAF is common in HCM patients undergoing myectomy and is a predictor of AF during follow-up. Over long-term follow-up, cardioembolic events are uncommon. These findings suggest that routine long-term anticoagulation for all HCM patients with postmyectomy AF is not justified after the initial postoperative period.

Complication and revision rates after reverse total shoulder revision from hemiarthroplasty: a systematic review.

Background: Thus, the purpose of the present study was to (1) characterize common postoperative complications and (2) quantify the rates of revision in patients undergoing hemiarthroplasty to reverse total shoulder arthroplasty revisional surgery. We hypothesize that hardware loosenings will be the most common complication to occur in the sample, with the humeral component being the most common loosening. Methods: This systematic review adhered to PRISMA reporting guideline. For our inclusion criteria, we included any study that contained intraoperative and/or postoperative complication data, and revision rates on patients who had undergone revision reverse total shoulder arthroplasty due to a failed hemiarthroplasty. Complications include neurologic injury, deep surgical site infections, hardware loosening/prosthetic instability, and postoperative fractures (acromion, glenoid, and humeral fractures). Results: The study contained 22 studies that assessed complications from shoulders that had revision reverse total shoulder arthroplasty from a hemiarthroplasty, with a total sample of 925 shoulders. We found that the most common complication to occur was hardware loosenings (5.3%), and of the hardware loosenings, humeral loosenings (3.8%) were the most common. The revision rate was found to be 10.7%. Conclusion: This systematic review found that revision reverse total shoulder arthroplasty for failed hemiarthroplasty has a high overall complication and reintervention rates, specifically for hardware loosening and revision rates.

Ventricular Septal Myectomy Decreases Long-Term Risk for Atrial Fibrillation in Patients With Hypertrophic Cardiomyopathy.

Atrial fibrillation (AF) is the most common sustained arrhythmia in hypertrophic cardiomyopathy (HCM) and is an important cause of morbidity and embolic stroke. The impact of outflow obstruction and the influence of surgical septal myectomy on the development of new-onset AF has not been well described. Consecutive patients with HCM without previous AF were followed for 5.0 ± 3.6 years for new-onset AF, including 717 with obstruction who did not undergo surgical myectomy (outflow gradients ≥30 mm Hg at rest or after provocation), 555 with nonobstructive HCM (outflow gradients <30 mm Hg), and 503 who underwent surgical myectomy. Patients with obstructive HCM who did not undergo myectomy had a 1.5-fold increased risk for new-onset AF compared with nonobstructive HCM (26% vs 16% at 10 years, hazard ratio = 0.69, p = 0.02). Patients who underwent myectomy had more advanced heart failure (95% vs 18% New York Heart Association class III, p <0.001) and had larger left atrium dimension (42 ± 7 vs 41 ± 7 mm; p <0.01) as compared with patients with obstructive HCM who did not undergo myectomy. However, after myectomy, the risk of new-onset AF was significantly lower than nonoperated obstructive (17% vs 26% at 10 years, p = 0.04) and no different from the risk of AF in patients with nonobstructive HC (hazard ratio 0.95, p = 0.81). In conclusion, patients with HCM with outflow obstruction are at a higher risk for AF compared with patients with nonobstructive HCM. However, after surgical myectomy, the risk for new-onset AF is substantially reduced. In addition to the known benefits of myectomy to permanently relieve outflow tract obstruction and mitral regurgitation, reverse heart failure symptoms, and increase longevity, myectomy is now shown to decrease susceptibility to AF in HCM.

Financial conflicts of interest during meetings of the cardiovascular and renal drugs advisory committee.

CONTEXT: The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the Food and Drug Administration (FDA) reviews safety and efficacy data for cardiovascular and renal drugs, ultimately making recommendations to the Commissioner of Food and Drugs for approval. The Open Public Hearing segment of these meetings allows for patients, advocates, healthcare professionals, clinical trialists, and members of the public to provide testimony, which often results in expressing their preference for, or against, drug approval. Prior to providing testimony, the public speakers are highly encouraged to disclose any financial conflicts of interest (FCOIs) with the sponsor or other groups. Given the potential influence of these speakers on drug approval recommendations, we investigated the industry associations disclosed by public speakers in the Open Public Hearing section of the CRDAC meetings. Previous studies, such as one done by Lurie et al. indicated that positive testimony is tied to a higher likelihood of drug approval, and because drug companies provide financial compensation for speakers to provide testimony in general, we wanted to determine the likelihood with which speakers who have an FCOI provided a positive testimony vs. those without any FCOI. OBJECTIVES: The purpose is to evaluate whether public speakers with an FCOI are more likely to provide positive testimony regarding the drug in question during the CRDAC of the FDA between February 2009 and December 2019 through the use of publicly available transcripts. METHODS: Independent researchers investigated public transcripts and minutes of the CRDAC meetings with public speakers (n=20). We identified all speakers, along with characteristics such as an FCOI, and classified statements utilizing a pilot-tested Google form. The data collected were analyzed utilizing Stata. The speaker's testimony was then compared with their FCOI. An ordered logistic regression was performed utilizing the speaker's testimony regarding the drug as the dependent variable. RESULTS: Of the 88 speakers represented in our sample, 35 (35/88, 39.8%) disclosed an FCOI, most commonly regarding travel cost. Among speakers with an FCOI, 30 (30/35, 85.7%) spoke positively. Speakers with an FCOI were 4.96 times more likely to provide positive testimony (OR=4.96, 95% CI 1.67-14.78). Speakers with the disease were also more likely to provide positive testimony (OR=13.05, 95% CI 2.84-59.93). CONCLUSIONS: Public speakers often play a role during meetings, and they may also have an FCOI, most commonly related to travel expenses. Our study shows that speakers with an FCOI are more likely to provide positive testimony. Stipulations, such as requiring disclosure of FCOI and randomizing the selection process of speakers, can help ensure the integrity of the drug approval process.

Accuracy of echocardiographic estimations of right heart pressures in adult heart transplant recipients.

BACKGROUND: Accurate assessment of right atrial pressure (RAP) and pulmonary artery systolic pressure (PASP) is critical in the management of heart transplant recipients. The accuracy of echocardiography in estimating these pressures has been debated. OBJECTIVE: To assess the correlation and agreement between echocardiographic estimations of right heart pressures with those of respective invasive hemodynamic measurements by right heart catheterization (RHC) in adult heart transplant recipients. METHODS: This is a prospective evaluation of 84 unique measurements from heart transplant recipients who underwent RHC followed by standard echocardiographic evaluation within 159 ± 64 min with no intervening medication changes. The relationship between noninvasive pressure estimations and invasive hemodynamic measurements was examined. RESULTS: Mean RAP was 7 ± 5 mmHg and mean PASP was 33 ± 8 mmHg by RHC. There was no significant correlation between echocardiographic estimation of RAP and invasive RAP (Spearman's rho = -0.05, p = .7), and no significant agreement between these two variables (weighted kappa = -0.1). There was a modest correlation between echocardiographic estimation of PASP and invasive PASP (r = .39, p = .002). Bland-Altman analysis showed a mean bias of 2.1 ± 9 mmHg (limits of agreement = -15 to 20 mmHg). CONCLUSION: In heart transplant recipients, there is no significant correlation or agreement between echocardiographic RAP estimation and invasively determined RAP. Noninvasive PASP estimation correlates significantly but modestly with invasively measured PASP. Further refinement of echocardiographic methods for assessment of RAP is warranted in this unique patient population.

Impact of comorbidities on atrial fibrillation and sudden cardiac death in hypertrophic cardiomyopathy.

BACKGROUND: The impact of comorbid disease states on the development of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy (HCM) remains unresolved. OBJECTIVE: Evaluate the association of comorbidities linked to arrhythmias in other cardiovascular diseases (e.g., obesity, systemic hypertension, diabetes, obstructive sleep apnea, renal disorders, tobacco, and alcohol use) to atrial fibrillation (AF) and sudden cardiac death (SCD) events in a large cohort of HCM patients. METHODS: A total  of 2269 patients, 54 ± 15 years of age, 1392 males, were evaluated at the Tufts HCM Institute between 2004 and 2018 and followed for an average of 4 ± 3 years for new-onset clinical AF and SCD events (appropriate defibrillation for ventricular tachyarrhythmias, resuscitated cardiac arrest, or SCD). RESULTS: One or more comorbidity was present in 75% of HCM patients, including 50% with ≥2 comorbidities, most commonly obesity (body mass index [BMI] ≥ 30 kg/m2 ) in 43%. New-onset atrial fibrillation developed in 11% of our cohort (2.6%/year). On univariate analysis, obesity was associated with a 1.7-fold increased risk for AF (p = .03) with 12% of obese patients developing AF (3.3%/year) as compared to 7% of patients with BMI < 25 kg/m2 (1.6%/year; p = .006). On multivariate analysis, age and LA transverse dimension emerged as the only variables predictive of AF. Comorbidities, including obesity, were not independently associated with AF development (p > .10 for each). SCD events occurred in 3.3% of patients (0.8%/year) and neither obesity nor other comorbidities were associated with increased risk for SCD (p > .10 for each). CONCLUSIONS: In adult HCM patients comorbidities do not appear to impact AF or SCD risk. Therefore, for most patients with HCM, adverse disease related events of AF and SCD appear to be primarily driven by underlying left ventricular and atrial myopathy as opposed to comorbidities.

Tonsillar-related pathologies: An analysis of the evidence underpinning management recommendations.

OBJECTIVE: Evidence-based decision making is crucial in reducing the health and economic burdens imposed by tonsillar-related pathologies. Clinical practice guidelines are used to guide these decisions; however, uptake of recommendations in these guidelines is low. Systematic reviews are the highest level of evidence used to influence guideline recommendations; therefore, improving the reporting and methodological quality of systematic reviews related to tonsillar-related pathologies may improve guideline uptake and patient care. METHODS: We used PubMed to search for all clinical practice guidelines related to tonsillar-related pathologies from 2010 to 2020. Included guidelines were then searched for all systematic reviews and meta-analyses. Study characteristics were extracted from each cited systematic review/meta-analysis before being evaluated using the PRISMA (Preferred Reporting Instrument for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) instruments. We then compared systematic reviews conducted by a Cochrane systematic review group with non-Cochrane systematic reviews. RESULTS: Seven clinical practice guidelines were included in our study and within these guidelines 98 SRs/MAs were cited, 80 of which were unique and included. Systematic reviews composed 9.1% (98/1082) of all guideline citations. Guideline PRISMA scores ranged from 0.47 to 0.83 with a mean score of 0.71 (n = 80) and guideline AMSTAR-2 scores ranged from 0.52 to 0.83 with a mean of 0.56 (7.29/13) and 0.75 (11.94/16) (n = 80). Cochrane systematic reviews displayed greater PRISMA (0.88 vs. 0.64: p < 0.001) and AMSTAR-2 (0.90 vs. 0.57; p < 0.001) scores compared to the non-Cochrane studies. We found PRISMA and AMSTAR-2 scores were positively correlated across guidelines (r = 0.93). CONCLUSION: Wide variation exists in adherence to PRISMA and AMSTAR-2 guidelines among systematic reviews cited in clinical practice guidelines for tonsillar-related pathologies. Prior registration and adequate risk of bias assessment are two areas where improvements may be needed. Given the importance of guideline uptake, careful considerations to improve the methodological and reporting quality of evidence supporting tonsillar-related pathology recommendations are necessary.

Development and Validation of a Clinical Predictive Model for Identifying Hypertrophic Cardiomyopathy Patients at Risk for Atrial Fibrillation: The HCM-AF Score.

[Figure: see text].

Public awareness of the National Suicide Prevention Lifeline following the release of a hip-hop song.

OBJECTIVE: In light of the current national mental health crisis, we use Google Trends, Twitter and data obtained from the National Suicide Prevention Lifeline to evaluate the effect of '1-800-273-8255' on public awareness for the National Suicide Prevention Lifeline. DESIGN: Cross-sectional analysis. MAIN OUTCOME MEASURES: We extracted data from Google Trends and Twitter for terms related to suicide following the release of Logic's song, '1-800-273-8255'. We then used a forecasting autoregressive integrated moving algorithm model to determine the greater than expected search interest. RESULTS: Google searches for 'Suicide Hotline' increased 49% more than expected the day after Logic's song was released and sustained increase of queries resulted in an average relative search volume of 59.5%-9.1% higher than the mean forecasted value of 50.4% for the 28 days following the release. Tweets that engaged with the account '@800 273talk' on Twitter increased by 10 450% more than expected the day after the song was released and increased by a mean of 1497% greater than expected the week after the songs released. CONCLUSION: Findings from our study suggest that the entertainment industry can play an important role in increasing awareness of hotline numbers. Logic's song provides an example of a positive influence on public health and provides support for further development and standards for proper awareness of suicide in the public view.

Angiotensin II Infusion for Shock: A Multicenter Study of Postmarketing Use.

BACKGROUND: Vasodilatory shock refractory to catecholamine vasopressors and arginine vasopressin is highly morbid and responsible for significant mortality. Synthetic angiotensin II is a potent vasoconstrictor that may be suitable for use in these patients. RESEARCH QUESTION: What is the safety and effectiveness of angiotensin II and what variables are associated with a favorable hemodynamic response? STUDY DESIGN AND METHODS: We performed a multicenter, retrospective study at five tertiary medical centers in the United States. The primary end point of hemodynamic responsiveness to angiotensin II was defined as attainment of mean arterial pressure (MAP) of ≥ 65 mm Hg with a stable or reduced total vasopressor dosage 3 h after drug initiation. RESULTS: Of 270 included patients, 181 (67%) demonstrated hemodynamic responsiveness to angiotensin II. Responders showed a greater increase in MAP (+10.3 mm Hg vs +1.6 mm Hg, P < .001) and reduction in vasopressor dosage (-0.20 µg/kg/min vs +0.04 µg/kg/min; P < .001) compared with nonresponders at 3 h. Variables associated with favorable hemodynamic response included lower lactate concentration (OR 1.11; 95% CI, 1.05-1.17, P < .001) and receipt of vasopressin (OR, 6.05; 95% CI, 1.98-18.6; P = .002). In severity-adjusted multivariate analysis, hemodynamic responsiveness to angiotensin II was associated with reduced likelihood of 30-day mortality (hazard ratio, 0.50; 95% CI, 0.35-0.71; P < .001). Arrhythmias occurred in 28 patients (10%) and VTE was identified in 4 patients. INTERPRETATION: In postmarketing use for vasopressor-refractory shock, 67% of angiotensin II recipients demonstrated a favorable hemodynamic response. Patients with lower lactate concentrations and those receiving vasopressin were more likely to respond to angiotensin II. Patients who responded to angiotensin II experienced reduced mortality.

Evaluation of the completeness of intervention reporting in Cochrane surgical systematic reviews using the TIDieR-SR checklist: a cross-sectional study.

INTRODUCTION: Complete reporting of systematic reviews of interventions is essential to the interpretation of research findings and the reproducibility of research results. The Template for Intervention Description and Replication (TIDieR) checklist-and the version specific to systematic reviews (TIDieR-SR)-was created to provide authors and researchers an evidence-based guide for reporting trial and systematic review interventions. In this study, we apply TIDieR-SR to Cochrane systematic reviews of surgical interventions. METHODS: We searched the Cochrane Database for relevant systematic reviews. Two investigators applied inclusion/exclusion criteria to all titles/abstracts and full texts. These same investigators extracted all data in duplicate while masked to the other's data. The primary outcome was adherence to TIDieR-SR items. RESULTS: Two hundred and thirty-eight systematic reviews were included. Overall, included SRs adhered to a median of 6 (IQR 5-7) out of eight TIDieR-SR items. The item with the lowest adherence was item 7 (share intervention materials, 1/238 (0.4%). DISCUSSION: Our results are encouraging, but the generalisability of our findings is compromised by the inclusion of only Cochrane systematic reviews. Future reporting of intervention materials is likely to improve the application of effective surgical interventions in the clinical practice.

An Evaluation of Reporting Guidelines and Clinical Trial Registry Requirements Among Addiction Medicine Journals.

CONTEXT: Robust methodology and ethical reporting are paramount for quality scientific research, but recently, that quality in addiction research has been questioned. Avenues to improve such research quality include adherence to reporting guidelines and proper usage of clinical trial registries. Reporting guidelines and clinical trial registries have been shown to lead researchers to more ethical and transparent methodology. OBJECTIVES: To investigate the reporting guideline and clinical trial registration policies of addiction research journals and identify areas of improvement. METHODS: We used Google Scholar Metrics' h-5 index to identify the top 20 addiction research journals. We then examined the instructions for authors from each journal to identify whether they required, recommended, or made no mention of trial registration and reporting guidelines, including the Consolidated Standards of Reporting Trials (CONSORT), Meta-Analysis of Observational Studies in Epidemiology (MOOSE), Quality of Reporting of Meta-analyses (QUOROM), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Standards for Reporting Diagnostic Accuracy Studies (STARD), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Animal Research: Reporting of In Vivo Experiments (ARRIVE), Case Reports (CARE), Consolidated Health Economic Evaluation Reporting Standards (CHEERS), Standards for Reporting Qualitative Research (SRQR), Standards for Quality Improvement Reporting Excellence (SQUIRE), Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), Consolidated Criteria for Reporting Qualitative Research (COREQ), Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD), Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P), and the International Committee of Medical Journal Editors (ICMJE) guidelines. We performed the same analysis regarding requirements for clinical trial registration. RESULTS: Of the 20 journals included in this study, 10 journals (50%) did not require adherence to any reporting guidelines. Trial registration followed a similar trend; 15 journals (75%) did not mention any form of trial or systematic review registration, and ClinicalTrials.gov was only recommended by only 1 journal (5%). CONCLUSIONS: Among top addiction medicine journals, required adherence to reporting guidelines and clinical trial registry policies remains substandard. A step toward fulfilling the National Institute on Drug Abuses' call for improvement in transparency and reproducibility within addiction research should include all journals adopting a strict reporting guideline and clinical trial registry adherence policy.

An Evaluation of the Presence of Spin in the Abstracts of Tonsillectomy Systematic Reviews.

OBJECTIVES/HYPOTHESIS: Spin-the practice of adding or omitting information intentionally or unintentionally to make the results of a study more favorable-may influence clinical decision making, especially when present in study abstracts. Here, we quantify and characterize the presence of spin in the abstracts of systematic reviews regarding tonsillectomy. METHODS: This study is an analysis of systematic review abstracts. Searches were conducted on September 23, 2019 on PubMed and Embase using the advanced search feature to retrieve systematic reviews regarding tonsillectomies. The nine most severe forms of spin were then evaluated. Spin was classified by two investigators in parallel, with each blinded to the classifications of the other. Study characteristics were also recorded in duplicate. Consensus meetings between investigators were held to resolve disagreements. RESULTS: In the 85 included systematic reviews, at least one form of spin was present in 44.7% (38/85) of abstracts. Journals with higher impact factors were less likely to contain spin in the abstracts of systematic reviews (point biserial correlation coefficient of -0.30). No statistically significant associations were found between the presence of spin and intervention type (P = .56) or adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (P = .08); however, there was a significant association between spin and funding source (P = .03). CONCLUSIONS: Spin was common in the abstracts of our sample of tonsillectomy systematic reviews. Researchers, clinicians, and peer reviewers could benefit from learning to recognize spin in medical literature. Further research is needed into the effects of spin on clinical decision making. LEVEL OF EVIDENCE: NA Laryngoscope, 2020.

Evaluation of "Spin" in the Abstracts of Randomized Controlled Trial Reports in Cardiology.

CONTEXT: The misrepresentation and distortion of research findings, known as "spin," has been shown to affect clinical decision making. Spin has been found in randomized controlled trials (RCTs) published in various fields of medicine. OBJECTIVE: To evaluate the abstracts of RCTs found in the cardiology literature for spin. METHODS: The authors searched PubMed using a specific string of keywords to identify previously published articles documenting RCTs of cardiovascular treatments in humans. To be included, a cardiology trial had to randomize humans to an intervention, statistically compare 2 or more groups, and have a nonsignificant primary endpoint. Records were excluded if they did not meet these criteria. Data extraction was double-blinded and done using a pilot-tested Google Form. Items extracted from each trial included the title, journal, funding source, comparator arm, primary endpoint, statistical analysis of the primary endpoint, secondary endpoints, statistical analysis of secondary endpoints, and trial registration number (if reported). The 2 authors who screened records for inclusion were then asked whether spin was present in the abstract of the randomized trial. Spin in the title, abstract results, abstract conclusions, and selection of reported endpoints were considered. RESULTS: Of the 651 PubMed citations retrieved by our search string, 194 RCTs with a clearly defined primary endpoint were identified. Of these 194 RCTs, 66 trials contained nonsignificant primary endpoints and were evaluated for spin. Of these trials, spin was identified in 18 of the 66 abstracts (27.3%). CONCLUSIONS: Spin was present in our sample of cardiology RCTs. Spin may influence clinical decision making by creating false impressions of the true validity of a drug or intervention.

Dubin-Johnson Syndrome Presenting During Cardiac Transplantation Evaluation.

Dubin-Johnson syndrome is a rare, benign disorder that results in conjugated hyperbilirubinemia. The disease manifests as intermittent jaundice without long-term hepatic or other clinical complications. This article reports a case of Dubin-Johnson syndrome, which was identified during cardiac transplant evaluation for cardiomyopathy secondary to a polyglycogen storage disease. The patient successfully underwent an orthotopic heart transplant. Postoperatively, her conjugated hyperbilirubinemia increased as compared to her baseline but resolved after several weeks. This report briefly reviews the hepatic manifestations in patients with Dubin-Johnson syndrome undergoing major surgery and highlights urinary coproporphyrin as a useful diagnostic test for Dubin-Johnson syndrome.

Evaluation of the Clarity and Completeness of Reporting in Orthopedic Clinical Practice Guidelines.

BACKGROUND: Clinical practice guidelines (CPGs) can positively affect the quality of patient care offered by physicians because they decrease variability in clinical practice and may help reduce unnecessary testing, promoting a more responsible use of resources. Building on existing framework for reporting guideline development, including the work of the Enhancing the Quality and Transparency of Health Research Network, the Reporting Items for Practice Guidelines in Healthcare (RIGHT) Working Group created a 2016 checklist of 35 items considered essential for high-quality reporting of CPGs. OBJECTIVES: To evaluate how many previously published CPGs in orthopedic surgery met the RIGHT criteria and assess how improvements can be made in future orthopedic CPGs based on any found deficiencies. METHODS: All 18 CPGs published before January 1, 2018, by the American Academy of Orthopedic Surgeons (AAOS) are publicly available on orthoguidelines.org. Two authors downloaded each file and both of those authors independently scored each CPG using piloted abstraction RIGHT checklist forms. RESULTS: Of the 35 RIGHT criteria outlined in 22 checklist items, 23 (65.7%) were met across all AAOS guidelines, 6 (17.1%) were not met by any of the AAOS guidelines, and 6 (17.2%) were met by some of the AAOS guidelines. CONCLUSION: Overall, the AAOS guidelines addressed many important recommendations within the RIGHT checklist. Assessing adherence to the RIGHT checklist can help ensure that future guidelines are more effectively communicated, hopefully assisting end users in efficient implementation and increasing the level of evidence-based patient care.

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials.

BACKGROUND AND AIMS: Selective outcome reporting occurs when trialists pre-specify primary and secondary outcomes during trial planning but alter the definitions in the published report. Here, we investigate selective outcome reporting in published addiction randomized controlled trials (RCTs) and evaluate whether particular funding sources are associated with an increased likelihood of selective outcome reporting. DESIGN: We conducted a cross-sectional study of published addiction clinical trials. A PubMed search was performed to identify RCTs in addiction journals from 2013 to 2017. Included studies used a randomized design to address one of the following topics: (1) drug, alcohol and tobacco addiction prevention, (2) stabilization following excessive use of a substance, (3) relapse prevention or (4) recovery maintenance. SETTING: Single-center, medical research institution. PARTICIPANTS: Our sample included 162 RCTs that were prospectively registered with a clearly defined primary outcome. MEASUREMENT: We extracted the following items from addiction RCTs: journal, funding source, trial registry number (if included), sample size, dates of subject enrollment, whether primary and secondary outcomes were denoted, all published outcomes, P-value for all outcomes and whether authors mentioned any deviations from the trial protocol as it related to RCT outcomes. FINDINGS: In total, 47 of 162 RCTs (29.0%) had at least one major discrepancy between the trial registry and published RCT. Overall, these 47 RCTs included 54 major discrepancies. The most common major discrepancy was demotion of a primary registered outcome (19/54, 35.2%). The majority of RCTs (132/162, 81.5%) were funded from public sources. Additionally, 166 RCTs were excluded from our sample because registration could not be confirmed. CONCLUSIONS: There is evidence suggestive of selective outcome reporting in addiction randomized controlled trials (RCTs). The most common major discrepancies pertained to the primary outcome.