The use of peer support groups for emergency physicians during the COVID-19 pandemic.

Objective: To test the feasibility, receptivity, and preliminary effectiveness of peer support groups for emergency medicine physicians during the COVID-19 pandemic and gain a better understanding of their experiences with peer support. Methods: This pilot study used a quasi-experimental design to assess change in symptoms of distress, anxiety, depression and burn-out before and after participating in a virtual, group-based peer support intervention for a duration of 8 weeks. Pre-post change analyses were performed using two-sided, paired t tests. Feasibility was measured by attendance data to demonstrate the use of the intervention. Receptivity was measured using a global change rating and net promoter score at the end of each session and 8-week period, respectively. During the final session, qualitative data on physician experience was collected and then analyzed using conventional content analysis. Results: Twenty-four emergency medicine physicians participated in the pilot study. The attendance goal was met by 20 (24, 83%) physicians and 19 (22, 86%) physicians reported they would recommend peer support groups to a friend of colleague. Positive standardized response mean effect sizes indicated modest improvement in nine of 12 symptom measurements with marginal significance (p < 0.10) for improvement in guilt [20, Effect Size (ES) = 0.45] and depression (21, ES = 0.39). Qualitative findings revealed high overall benefit with few adverse impacts of participation. Conclusions: Results demonstrate high physician receptivity, feasibility, and benefit from participation in peer support groups. Promising signs of improvement in distress, anxiety, depression, and burn out symptoms warrant additional studies with larger sample sizes and more robust research designs to establish the evidence base for peer support in the physician population.

"Your Tiny White Vests, Unworn": Contemporary Elegies of Maternal Loss.

This essay asks whether poetry can articulate the experience of maternal loss, paying particular attention to questions of form. Focusing on two British poetry collections, Rebecca Goss's Her Birth (2013) and Karen McCarthy Woolf's An Aviary of Small Birds (2014), I argue that the contemporary elegy is currently being reshaped to explore the grief of losing a baby, and to bear witness to a life briefly lived. Drawing on Caroline Levine's emphasis on the affordances of form, the essay first examines these elegies' aural qualities thorugh the motif of the echo. Next I attend to the shaping of the poems, and how their word placement gives weight to the experience of baby loss. Finally, I consider how the modes of address at the end of the two collections negotiate the possibility of moving forward.

Catastrophic Antiphospholipid Syndrome Presenting as a Stroke in an 11-Year-Old with Lupus.

Catastrophic antiphospholipid syndrome (CAPS) is an infrequent but feared life-threatening complication of antiphospholipid syndrome (APS). CAPS is characterized by the rapid development of numerous thromboses across multiple organs resulting in multiorgan failure. It is rare but well-documented in the adult population. In contrast, it is exceedingly uncommon in pediatric patients and therefore not yet well described in the pediatric literature. Early recognition of APS is of the utmost importance to provide timely and effective management for a positive outcome. We present the case of an 11-year-old girl with history of systemic lupus erythematosus (SLE) and hypertension (HTN) who presented with acute onset altered mental status, found to have a large ischemic middle cerebral artery (MCA) and anterior cerebral artery (ACA) stroke as well as multiple, diffuse, and smaller ischemic lesions in the frontal lobe and cerebellum. Her presentation was further complicated by thrombocytopenia and renal and splenic infarction, as well as thrombosis of the right brachial vein consistent with a diagnosis of CAPS.

Use of the "Future Life Map" exercise to improve awareness of career options and opportunities in underrepresented minority undergraduate students pursuing STEM careers.

OBJECTIVES: There has long existed significant underrepresentation of minority students in STEM training and careers. Ongoing efforts to improve opportunities and participation for underrepresented minority students have focused on multiple areas, from increased funding to early exposure to research in STEM. We developed the novel Future Life Map career planning exercise with the goal of contributing to this multi-faceted approach. The exercise emphasizes on the consideration of multiple potential career destinations and routes to those destination. The exercise was designed with the goal of improving participant awareness of options and career planning self-efficacy to improve success and retention of underrepresented minority student participation and retention in STEM. METHODS: We implemented the Future Life Map exercise with 2 separate groups of under-represented minority undergraduate students pursuing careers in STEM. Participants then completed an anonymous survey to evaluate the exercise and describe the value they derived from completing the Future Life Map. RESULTS: The exercise presentation and its supporting documents were highly rated by participants with >81% of respondents rating it as "very informative" (4 or 5 on a 5-point Likert Scale). Participants reported that they were very likely to recommend the exercise to others (25 of 27 participants) and were likely to repeat the activity for their own future decision making (22 participants). Themes that emerged from participant reporting of the value of the exercise were: increased awareness of career and training options, improved understanding of the research required to make informed career/life decisions, and new awareness of specific information about career options under consideration. CONCLUSION: The Future Life Map exercise was successful in improving participant awareness of career options, career planning ability, and helped participants to feel more empowered. This is likely of particular benefit for improving participation and retention of under-represented minority students pursuing careers in STEM.

A Lecture to Teach an Approach and Improve Resident Comfort in Leading Resuscitation of Young Infants in the Emergency Department.

Audience: The intended audience of this lecture is emergency medicine residents at all levels of training. It is also appropriate for practicing emergency physicians interested in improving comfort in resuscitating sick young infants, ages 0-60 days. Introduction: The majority of sick and injured children in the United States are seen and treated in general emergency departments.1 This includes very young infants (0-60 days old) in need of immediate resuscitation. Resuscitation of children in this age group involves use of specific knowledge and skills that residents and emergency physicians in general have fewer opportunities to practice.2,3 Emergency medicine residents and practicing emergency physicians often report this as an area of particular discomfort in practice.4,5 It is important that the inconsistent and infrequent opportunities to resuscitate young infants during emergency medicine residency and beyond are supplemented by residency didactics that focus on improving comfort and skills with this population of sick children. This lecture focuses on a practical approach intended to improve the relevant knowledge, skills, and confidence required to stabilize a critically ill young infant in a general emergency department. Educational Objectives: By the end of this lecture, participants should be able to:Apply a consistent approach to the initial resuscitation of a critically ill young infant in the emergency department.Select appropriate medications and equipment for use in resuscitation of critically ill young infants.Describe the components of the Pediatric Assessment Triangle,6 which can be used to identify critically ill infants and children.Improve comfort in resuscitating young infants in the emergency department. Educational Methods: This is a live lecture format using PowerPoint slides. The lecture emphasizes a practical approach to improve the skills and knowledge required for successful young infant resuscitation. It utilizes a case-based approach, and encourages the audience to determine next steps in care to mimic the real time decision-making required for care of critically ill young infants in the ED. Research Methods: Learners were asked to fill out anonymous pre- and post quizzes immediately prior to and directly after the lecture was given. These surveys included questions to assess resident knowledge as well as resident comfort as it pertained to resuscitation of critically ill young infants. Results: Resident comfort with resuscitation of young infants improved with a mean Standard Deviation (SD) pre-lecture rating of 23.1(14.9) on a 100-point visual analog scale and a mean (SD) post lecture rating of 46.7(14.6). Resident performance on all knowledge base questions improved on the post-lecture quiz for all four questions asked. Discussion: This lecture was effective in improving emergency medicine resident comfort and practical knowledge pertaining to resuscitation of young infants in the emergency department. The emphasis on a practical approach was well received by the resident audience, and they engaged well with audience participation portions of the lecture. The impact of the lecture can be enhanced by having the lecturer share their own real-world experience of resuscitation of young infants in the emergency department during the discussion portions of the lecture. Topics: Neonatal resuscitation, infant resuscitation, pediatric assessment triangle, neonatal sepsis, congenital heart disease, congenital adrenal hyperplasia, non-accidental trauma, malrotation.

A Resident Morbidity and Mortality Conference Curriculum to Teach Identification of Cognitive Biases, Errors, and Debiasing Strategies.

Introduction: The morbidity and mortality (M&M) conference has long been a part of the education of residents of all specialties in the United States, yet its structure is variable across training programs. Recent literature has described the use of M&M as a forum for education in quality improvement methodology; however, a structure focusing on education in cognitive biases and errors has not been previously described in MedEdPORTAL. Methods: This structured M&M conference series called upon resident presenters and peers in the audience to examine cognitive biases and errors involved in specific patient cases. Associated materials included preparatory guidelines provided to faculty advisors and resident presenters, a presentation template used during the introductory session, and a handout used during the discussion portions of presentations. Results: During the 2019-2020 academic year, a total of 24 PGY 2 pediatrics residents presented M&M cases. They identified a mean of 3.7 (SD = 1.9) cognitive biases and/or errors per case and a mean of 1.7 (SD = 0.7) debiasing strategies per case. Peers in the audience were also successful in identifying potential biases and errors at play during presentations. Discussion: We found that through this M&M conference structure, residents were able to demonstrate the ability to identify cognitive errors and biases both within themselves and in peers. This provided an effective forum for the identification and discussion of debiasing strategies, even when the series was forced to transition to a virtual format due to the COVID-19 pandemic.

Changing perceptions about COVID-19 risk and adherence to preventive strategies in Uganda: Evidence from an online mixed-methods survey.

Since the COVID-19 pandemic started, countries have enacted a series of non-clinical preventive mechanisms aimed at slowing the rate of spread. However, these mechanisms can be effective only when they are correctly followed and only when individuals believe the risk of COVID-19 is high enough to warrant following them. As risk perceptions decline, individuals are more likely to relax following preventive measures and the rate of spread might increase. This study assesses the determinants of changes in perceptions of COVID-19 risk and the determinants of adherence to preventive measures in Uganda. Logistic regression results show that age, access to information and being supportive of preventive measures strongly predicts keeping higher risk perceptions and adhering to preventive actions. Qualitative results show that risk perceptions are also influenced by economic stress, citizens' level of confidence in the government, local political climate and the extent of proliferation of misinformation about COVID-19.

Emerging and Re-emerging Infections in Children: COVID/ MIS-C, Zika, Ebola, Measles, Varicella, Pertussis ... Immunizations.

The role of the emergency provider lies at the forefront of recognition and treatment of novel and re-emerging infectious diseases in children. Familiarity with disease presentations that might be considered rare, such as vaccine-preventable and non-endemic illnesses, is essential in identifying and controlling outbreaks. As we have seen thus far in the novel coronavirus pandemic, susceptibility, severity, transmission, and disease presentation can all have unique patterns in children. Emergency providers also have the potential to play a public health role by using lessons learned from the phenomena of vaccine hesitancy and refusal.

Minimizing Ionizing Radiation in Evaluating Suspected Appendicitis in Children Before and After the Release of the ACEP Clinical Policy.

STUDY OBJECTIVE: The aim of this study was to examine the impact of the ACEP (American College of Emergency Physicians) clinical policy regarding diagnosis of suspected appendicitis on changing practice in the pediatric emergency department (ED) in the absence of a formal departmental protocol. METHODS: This was a retrospective chart review in a pediatric ED in which patients aged 2 to 18 years were evaluated for appendicitis via ultrasound, computed tomography (CT), or both, over a 7-year study period. We compared rates of CT utilization in the period before the release of the ACEP clinical policy regarding diagnosis and treatment of appendicitis (2008-2009) and the period after (2010-2014). Other metrics of interest were ultrasound results and physician response to results, as well as surrogate markers for quality of care. RESULTS: Seven hundred pediatric ED visits were included, with 200 prepolicy release and 500 postrelease. Computed tomography utilization decreased significantly postpolicy release from 43.5% (95% confidence interval [CI], 36.6%-50.3%) to 22.2% (95% CI, 18.5%-25.8%). The proportion of ultrasounds with indeterminate results also decreased, with 71.5% (95% CI, 65.1%-77.9%) and 55.1% (95% CI, 50.7%-59.5%) in the pre and post groups, respectively. Physicians ordered fewer CTs after indeterminate ultrasounds, decreasing from 63.7% (95% CI, 56.9%-70.5%) to 48.3%% (95% CI, 43.9%-52.7%). CONCLUSIONS: After the release of the clinical policy, CT utilization decreased significantly suggesting possible effectiveness of the policy in bringing about change in practice. Subsequently, there was an increase in the definitiveness in the ultrasound results. Physicians also evolved in their response to indeterminate ultrasound results, with fewer CTs ordered reflexively after indeterminate results.

Experimental designs for detecting synergy and antagonism between two drugs in a pre-clinical study.

The identification of synergistic interactions between combinations of drugs is an important area within drug discovery and development. Pre-clinically, large numbers of screening studies to identify synergistic pairs of compounds can often be ran, necessitating efficient and robust experimental designs. We consider experimental designs for detecting interaction between two drugs in a pre-clinical in vitro assay in the presence of uncertainty of the monotherapy response. The monotherapies are assumed to follow the Hill equation with common lower and upper asymptotes, and a common variance. The optimality criterion used is the variance of the interaction parameter. We focus on ray designs and investigate two algorithms for selecting the optimum set of dose combinations. The first is a forward algorithm in which design points are added sequentially. This is found to give useful solutions in simple cases but can lack robustness when knowledge about the monotherapy parameters is insufficient. The second algorithm is a more pragmatic approach where the design points are constrained to be distributed log-normally along the rays and monotherapy doses. We find that the pragmatic algorithm is more stable than the forward algorithm, and even when the forward algorithm has converged, the pragmatic algorithm can still out-perform it. Practically, we find that good designs for detecting an interaction have equal numbers of points on monotherapies and combination therapies, with those points typically placed in positions where a 50% response is expected. More uncertainty in monotherapy parameters leads to an optimal design with design points that are more spread out.

Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio.

This paper presents an approximate closed form sample size formula for determining non-inferiority in active-control trials with binary data. We use the odds-ratio as the measure of the relative treatment effect, derive the sample size formula based on the score test and compare it with a second, well-known formula based on the Wald test. Both closed form formulae are compared with simulations based on the likelihood ratio test. Within the range of parameter values investigated, the score test closed form formula is reasonably accurate when non-inferiority margins are based on odds-ratios of about 0.5 or above and when the magnitude of the odds ratio under the alternative hypothesis lies between about 1 and 2.5. The accuracy generally decreases as the odds ratio under the alternative hypothesis moves upwards from 1. As the non-inferiority margin odds ratio decreases from 0.5, the score test closed form formula increasingly overestimates the sample size irrespective of the magnitude of the odds ratio under the alternative hypothesis. The Wald test closed form formula is also reasonably accurate in the cases where the score test closed form formula works well. Outside these scenarios, the Wald test closed form formula can either underestimate or overestimate the sample size, depending on the magnitude of the non-inferiority margin odds ratio and the odds ratio under the alternative hypothesis. Although neither approximation is accurate for all cases, both approaches lead to satisfactory sample size calculation for non-inferiority trials with binary data where the odds ratio is the parameter of interest.

Cholesterol-lowering effects of oat ß-glucan: a meta-analysis of randomized controlled trials.

BACKGROUND: Health claims regarding the cholesterol-lowering effect of soluble fiber from oat products, approved by food standards agencies worldwide, are based on a diet containing ≥3 g/d of oat ß-glucan (OBG). Given the number of recently published randomized controlled trials (RCTs), it is important to update the findings of previous meta-analyses. OBJECTIVE: The objective was to quantify the effect of ≥3 g OBG/d on serum cholesterol concentrations in humans and investigate potential effect modifiers. DESIGN: A meta-analysis was performed on 28 RCTs comparing ≥3 g OBG/d with an appropriate control. Systematic searches were undertaken in PubMed, AGRICOLA, and Scopus between 1 January 1966 and 6 June 2013, plus in-house study reports at CreaNutrition AG. Studies were assessed with regard to inclusion/exclusion criteria, and data were extracted from included studies by reviewers working independently in pairs, reconciling differences by consensus. Estimates of the mean reduction in serum cholesterol from baseline between the OBG and control diets were analyzed by using random-effects meta-analysis models and meta-regression. RESULTS: OBG in doses of ≥3 g/d reduced low-density lipoprotein (LDL) and total cholesterol relative to control by 0.25 mmol/L (95% CI: 0.20, 0.30; P < 0.0001) and 0.30 mmol/L (95% CI: 0.24, 0.35; P < 0.0001), respectively, with some indication of heterogeneity (P = 0.13 and P = 0.067). There was no significant effect of OBG on high-density lipoprotein (HDL) cholesterol or triglycerides and no evidence that dose (range across trials: 3.0-12.4 g/d) or duration of treatment (range: 2-12 wk) influenced the results. LDL cholesterol lowering was significantly greater with higher baseline LDL cholesterol. There was a significantly greater effect for both LDL and total cholesterol in subjects with diabetes compared with those without (although based on few studies). CONCLUSIONS: Adding ≥3 g OBG/d to the diet reduces LDL and total cholesterol by 0.25 mmol/L and 0.30 mmol/L, respectively, without changing HDL cholesterol or triglycerides.

Bridging the gap: a review of dose investigations in paediatric investigation plans.

AIMS: In the EU, development of new medicines for children should follow a prospectively agreed paediatric investigation plan (PIP). Finding the right dose for children is crucial but challenging due to the variability of pharmacokinetics across age groups and the limited sample sizes available. We examined strategies adopted in PIPs to support paediatric dosing recommendations to identify common assumptions underlying dose investigations and the attempts planned to verify them in children. METHODS: We extracted data from 73 PIP opinions recently adopted by the Paediatric Committee of the European Medicines Agency. These opinions represented 79 medicinal development programmes and comprised a total of 97 dose investigation studies. We identified the design of these dose investigation studies, recorded the analyses planned and determined the criteria used to define target doses. RESULTS: Most dose investigation studies are clinical trials (83 of 97) that evaluate a single dosing rule. Sample sizes used to investigate dose are highly variable across programmes, with smaller numbers used in younger children (< 2 years). Many studies (40 of 97) do not pre-specify a target dose criterion. Of those that do, most (33 of 57 studies) guide decisions using pharmacokinetic data alone. CONCLUSIONS: Common assumptions underlying dose investigation strategies include dose proportionality and similar exposure-response relationships in adults and children. Few development programmes pre-specify steps to verify assumptions in children. There is scope for the use of Bayesian methods as a framework for synthesizing existing information to quantify prior uncertainty about assumptions. This process can inform the design of optimal drug development strategies.

A Bayesian approach to dose-finding studies for cancer therapies: incorporating later cycles of therapy.

We consider phase I dose-finding studies for cytotoxic drugs in cancer, where the objective is identification of a target dose (TD100δ ) associated with the probability δ of a dose-limiting toxicity (DLT). Previous authors have presented a design utilising a Bayesian decision procedure based on a logistic regression model to describe the relationship between dose and the risk of a DLT (LRDP). A cautious prior, chosen to ensure that the first cohort of patients are given the lowest dose, is combined with binary observations of DLTs to update model parameters and choose a safe dose for the next cohort. This process continues with each new cohort of patients. Typically, only DLTs occurring in the first treatment cycle are included. To incorporate data from later cycles, a new Bayesian decision procedure based on an interval-censored survival model (ICSDP) has been developed. This models the probability that the first DLT occurs in each specific cycle via the probability of a DLT during a specific cycle, conditional on having no DLT in any previous cycle. The second cohort of patients start after responses have been obtained from the first cycle of the first cohort, and subsequently, dose selection for each new cohort is based on DLTs observed across all completed cycles for all patients. A simulation study comparing the ICSDP and LRDP showed that the ICSDP induces faster updating of the current estimate of the target dose, leading to shorter trials and fewer patients, whilst keeping the same level of accuracy.

Manual vs. integrated automatic load-distributing band CPR with equal survival after out of hospital cardiac arrest. The randomized CIRC trial.

OBJECTIVE: To compare integrated automated load distributing band CPR (iA-CPR) with high-quality manual CPR (M-CPR) to determine equivalence, superiority, or inferiority in survival to hospital discharge. METHODS: Between March 5, 2009 and January 11, 2011 a randomized, unblinded, controlled group sequential trial of adult out-of-hospital cardiac arrests of presumed cardiac origin was conducted at three US and two European sites. After EMS providers initiated manual compressions patients were randomized to receive either iA-CPR or M-CPR. Patient follow-up was until all patients were discharged alive or died. The primary outcome, survival to hospital discharge, was analyzed adjusting for covariates, (age, witnessed arrest, initial cardiac rhythm, enrollment site) and interim analyses. CPR quality and protocol adherence were monitored (CPR fraction) electronically throughout the trial. RESULTS: Of 4753 randomized patients, 522 (11.0%) met post enrollment exclusion criteria. Therefore, 2099 (49.6%) received iA-CPR and 2132 (50.4%) M-CPR. Sustained ROSC (emergency department admittance), 24h survival and hospital discharge (unknown for 12 cases) for iA-CPR compared to M-CPR were 600 (28.6%) vs. 689 (32.3%), 456 (21.8%) vs. 532 (25.0%), 196 (9.4%) vs. 233 (11.0%) patients, respectively. The adjusted odds ratio of survival to hospital discharge for iA-CPR compared to M-CPR, was 1.06 (95% CI 0.83-1.37), meeting the criteria for equivalence. The 20 min CPR fraction was 80.4% for iA-CPR and 80.2% for M-CPR. CONCLUSION: Compared to high-quality M-CPR, iA-CPR resulted in statistically equivalent survival to hospital discharge.

Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: results of a randomized trial.

PURPOSE: We wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265). METHODS AND MATERIALS: The study was a double-blind comparison of MF with D (Diprobase), administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy, 40 Gy in 2.67-Gy fractions daily over 3 weeks. The primary endpoint was mean modified Radiation Therapy Oncology Group (RTOG) score. RESULTS: Mean RTOG scores were significantly less for MF than for D (P=.046). Maximum RTOG and mean erythema scores were significantly less for MF than for D (P=.018 and P=.012, respectively). The Dermatology Life Quality Index (DLQI) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression (HAD) questionnaire scores. CONCLUSIONS: MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. For the first time, we have shown a significantly beneficial effect on quality of life using a validated instrument (DLQI), for a topical steroid cream. We believe that application of this cream should be the standard of care where radiation dermatitis is expected.

Investigation of the robustness of two models for assessing synergy in pre-clinical drug combination studies.

Pre-clinical studies may be used to screen for synergistic combinations of drugs. The types of in vitro assays used for this purpose will depend upon the disease area of interest. In oncology, one frequently used study measures cell line viability: cells placed into wells on a plate are treated with doses of two compounds, and cell viability is assessed from an optical density measurement corrected for blank well values. These measurements are often transformed and analysed as cell survival relative to untreated wells. The monotherapies are assumed to follow the Hill equation with lower and upper asymptotes at 0 and 1, respectively. Additionally, a common variance about the dose-response curve may be assumed. In this paper, we consider two models for incorporating synergy parameters. We investigate the effect of different models of biological variation on the assessment of synergy from both of these models. We show that estimates of the synergy parameters appear to be robust, even when estimates of the other model parameters are biased. Using untransformed measurements provides better coverage of the 95% confidence intervals for the synergy parameters than using transformed measurements, and the requirement to fit the upper asymptote does not cause difficulties. Assuming homoscedastic variances appears to be robust. The added complexity of determining and fitting an appropriate heteroscedastic model does not seem to be justified.

A C++ program to calculate sample sizes for cost-effectiveness trials in a Bayesian framework.

Cost-Effectiveness Analysis (CEA) has become an increasingly important component of clinical trials. However, formal sample size calculations for such studies are not common. One of the reasons for this might be due to the absence of readily available computer software to perform complex calculations, particularly in a Bayesian setting. In this paper, a C++ program (using NAG library functions/subroutines) is presented to estimate the sample sizes for cost-effectiveness clinical trials in a Bayesian framework. The program can equally be used to calculate sample sizes for efficacy trials. The Bayesian approach to sample size calculation is based on that of O'Hagan and Stevens (A. O'Hagan, J.W. Stevens, Bayesian assessment of sample size for clinical trials of cost-effectiveness, Medical Decision Making 21 (2001) 219-230). With this program, the user can calculate sample sizes for various thresholds of willingness to pay and under various assumptions of the correlations between cost and effects. Under some prior, the program produces frequentist sample size as well. The program runs under windows environment and running time is very short.

Methodological quality of meta-analyses: matched-pairs comparison over time and between industry-sponsored and academic-sponsored reports.

CONTEXT: Meta-analyses are regularly used to inform healthcare decisions. Concerns have been expressed about the quality of meta-analyses and, in particular, about those supported by the pharmaceutical industry. OBJECTIVE: The objective of this study is to compare the quality of pharmaceutical-industry-supported meta-analyses with academic meta-analyses and of meta-analyses published before and after companies started to disclose their data. DATA SOURCES: We identified industry-supported meta-analyses by searching the Scopus bibliographic database, using author affiliations. We matched each industry-supported meta-analysis with an academic meta-analysis using high-level MeSH terms in PubMed. STUDY SELECTION: We included meta-analyses of randomized trials assessing the efficacy or safety of any pharmaceutical intervention in humans, published in 2002-2004 or 2008-2009. Cochrane reviews were excluded. Two individuals independently selected papers, with discrepancies resolved by two further individuals. ASSESSMENT: We developed and piloted a quality-assessment tool, consisting of 43 questions in four domains, with a key summary question covering each domain. Two individuals independently assessed each meta-analysis. RESULTS: We examined 126 meta-analysis publications in 63 matched pairs. The average quality was low, with fewer than 50% adequate in three of the four domains. Industry-supported meta-analyses less often demonstrated adequate methods for locating studies and assessing their quality (odds ratio 0.44, 95% confidence interval 0.21 to 0.92), for analysing the included studies (0.52, 0.25 to 1.06), for undertaking meta-analyses (0.82, 0.40 to 1.68) and in reaching sound conclusions (0.62, 0.30 to 1.28). Quality generally improved over time, particularly for some aspects of industry reports. CONCLUSIONS: Academic meta-analysis papers are generally of higher quality than industry-supported ones. This is largely due to less detailed reporting in industry-supported meta-analyses and a tendency for them to take the included studies at face value, probably arising from the implicit assumption that these studies already have high methodological standards to meet licensing requirements. The improved quality over time does not appear to be due to the use of data disclosed by industry. The main limitations of this study are the small sample of papers and the subjective nature of some of the assessment processes.

A tool to assess the quality of a meta-analysis.

BACKGROUND: Because meta-analyses are increasingly prevalent and cited in the medical literature, it is important that tools are available to assess their methodological quality. When performing an empirical study of the quality of published meta-analyses, we found that existing tools did not place a strong emphasis on statistical and interpretational issues. METHODS: We developed a quality-assessment tool using existing materials and expert judgment as a starting point, followed by multiple iterations of input from our working group, piloting, and discussion. After having used the tool for our empirical study, agreement for four key items in the tool was measured using weighted kappa coefficients. RESULTS: Our tool contained 43 items divided into four key areas (data sources, analysis of individual studies, meta-analysis methods, and interpretation), and each area ended with a summary question. We also produced guidance for completing the tool. Agreement between raters was fair to moderate. CONCLUSIONS: The tool should usefully inform subsequent initiatives to develop quality-assessment tools for meta-analysis. We advocate use of consensus between independent raters when assessing statistical appropriateness and adequacy of interpretation in meta-analyses.