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One challenge in medical education is the inability to compare and aggregate outcomes data across continuing educational activities due to variations in evaluation tools, data collection approaches and reporting. To address this challenge, Gilead collaborated with CE Outcomes to develop, pilot, and implement a standardized outcomes evaluation across Gilead directed medical education activities around the world. Development of the standardized tool occurred during late 2018, with Gilead stakeholders invited to provide input on the questions and structure of the evaluation form. Once input was captured, a draft evaluation tool was developed and circulated for feedback. Questions were created to collect 1) participant demographic characteristics 2)data on planned changes to practice, key learnings and anticipated barriers, and 3) learner satisfaction with content and perceived achievement of learning objectives. The evaluation tool was piloted in H1 2019 across 7 medical education activities. Revisions based on pilot feedback were incorporated. The evaluation tool was broadly released during H2 2019 and data were collected from over 30 educational activities. By the end of 2019, it was possible to compare outcomes results from individual activities and aggregate data to demonstrate overall educational reach and impact. Continuing education activities provide valuable up-to-date information to clinicians with the goal of improving patient care. While often challenging to highlight the impact of education due to variations in outcomes, this standardized approach establishes a method to collect meaningful outcomes data that demonstrates the collective impact of continuing education and allows for comparison across individual activities.

Purpose To improve the outcome of the acute respiratory distress syndrome (ARDS), one needs to identify potentially modifiable factors associated with mortality. Methods The large observational study to understand the global impact of severe acute respiratory failure (LUNG SAFE) was an international, multicenter, prospective cohort study of patients with severe respiratory failure, conducted in the winter of 2014 in a convenience sample of 459 ICUs from 50 countries across five continents. A pre-specified secondary aim was to examine the factors associated with outcome. Analyses were restricted to patients (93.1 %) fulfilling ARDS criteria on day 1–2 who received invasive mechanical ventilation. Results 2377 patients were included in the analysis. Potentially modifiable factors associated with increased hospital mortality in multivariable analyses include lower PEEP, higher peak inspiratory, plateau, and driving pressures, and increased respiratory rate. The impact of tidal volume on outcome was unclear. Having fewer ICU beds was also associated with higher hospital mortality. Non-modifiable factors associated with worsened outcome from ARDS included older age, active neoplasm, hematologic neoplasm, and chronic liver failure. Severity of illness indices including lower pH, lower PaO 2 /FiO 2 ratio, and higher non-pulmonary SOFA score were associated with poorer outcome. Of the 578 (24.3 %) patients with a limitation of life-sustaining therapies or measures decision, 498 (86.0 %) died in hospital. Factors associated with increased likelihood of limitation of life-sustaining therapies or measures decision included older age, immunosuppression, neoplasia, lower pH and increased non-pulmonary SOFA scores. Conclusions Higher PEEP, lower peak, plateau, and driving pressures, and lower respiratory rate are associated with improved survival from ARDS. Trial Registration: ClinicalTrials.gov NCT02010073.

Background To provide empirical evidence about prevalence, reporting and handling of missing outcome data in systematic reviews with network meta-analysis and acknowledgement of their impact on the conclusions. Methods We conducted a systematic survey including all published systematic reviews of randomized controlled trials comparing at least three interventions from January 1, 2009 until March 31, 2017. Results We retrieved 387 systematic reviews with network meta-analysis. Description of missing outcome data was available in 63 reviews. Intention-to-treat analysis was the most prevalent method (71%), followed by missing outcome data investigated as secondary outcome (e.g., acceptability) (40%). Bias due to missing outcome data was evaluated in half the reviews with explicit judgments in 18 (10%) reviews. Only 88 reviews interpreted their results acknowledging the implications of missing outcome data and mostly using the network meta-analysis results on missing outcome data as secondary outcome. We were unable to judge the actual strategy applied to deal with missing outcome data in 65% of the reviews due to insufficient information. Six percent of network meta-analyses were re-analyzed in sensitivity analysis considering missing outcome data, while 4% explicitly justified the strategy for dealing with missing outcome data. Conclusions The description and handling of missing outcome data as well as the acknowledgment of their implications for the conclusions from network meta-analysis are deemed underreported.

Background Missing participant outcome data (MOD) are ubiquitous in systematic reviews with network meta-analysis (NMA) as they invade from the inclusion of clinical trials with reported participant losses. There are available strategies to address aggregate MOD, and in particular binary MOD, while considering the missing at random (MAR) assumption as a starting point. Little is known about their performance though regarding the meta-analytic parameters of a random-effects model for aggregate binary outcome data as obtained from trial-reports (i.e. the number of events and number of MOD out of the total randomised per arm). Methods We used four strategies to handle binary MOD under MAR and we classified these strategies to those modelling versus excluding/imputing MOD and to those accounting for versus ignoring uncertainty about MAR. We investigated the performance of these strategies in terms of core NMA estimates by performing both an empirical and simulation study using random-effects NMA based on electrical network theory. We used Bland-Altman plots to illustrate the agreement between the compared strategies, and we considered the mean bias, coverage probability and width of the confidence interval to be the frequentist measures of performance. Results Modelling MOD under MAR agreed with exclusion and imputation under MAR in terms of estimated log odds ratios and inconsistency factor, whereas accountability or not of the uncertainty regarding MOD affected intervention hierarchy and precision around the NMA estimates: strategies that ignore uncertainty about MOD led to more precise NMA estimates, and increased between-trial variance. All strategies showed good performance for low MOD (<5%), consistent evidence and low between-trial variance, whereas performance was compromised for large informative MOD (> 20%), inconsistent evidence and substantial between-trial variance, especially for strategies that ignore uncertainty due to MOD. Conclusions The analysts should avoid applying strategies that manipulate MOD before analysis (i.e. exclusion and imputation) as they implicate the inferences negatively. Modelling MOD, on the other hand, via a pattern-mixture model to propagate the uncertainty about MAR assumption constitutes both conceptually and statistically proper strategy to address MOD in a systematic review.

The aim was to review different approaches for the derivation of threshold values and to discuss their strengths and limitations in the context of minimum provider volumes. The following methods for the calculation of threshold values are compared and discussed: The value of acceptable risk limit, the value of acceptable risk gradient, the benchmark value proposed by Budtz-Jørgensen and Ulm's breakpoint model. The latter is extended to account for two different breakpoints. The methods are applied to German quality assurance data concerning total knee replacement. The discussed methods for calculating threshold values differ in the kind of information that has to be specified beforehand. For the value of acceptable risk limit approach an absolute number, the acceptable risk, has to be predetermined. The value of acceptable risk gradient approach and the method of Budtz-Jørgensen require the specification of a relative change expressed in gradient and in odds, respectively. On the other hand, the threshold value according to the method of Ulm is defined as a parameter of a statistical model and no a priori specification is required. Each of the proposed methods has benefits and drawbacks. The choice of the most appropriate approach depends on the specific problem and the available data.

Abstract BACKGROUND The choice of anterior vs posterior approach for degenerative cervical myelopathy that spans multiple segments remains controversial. OBJECTIVE To compare the outcomes following the 2 approaches using multicenter prospectively collected data. METHODS Quality Outcomes Database (QOD) for patients undergoing surgery for 3 to 5 level degenerative cervical myelopathy was analyzed. The anterior group (anterior cervical discectomy [ACDF] or corpectomy [ACCF] with fusion) was compared with posterior cervical fusion. Outcomes included: patient reported outcomes (PROs): neck disability index (NDI), numeric rating scale (NRS) of neck pain and arm pain, EQ-5D, modified Japanese Orthopedic Association score for myelopathy (mJOA), and NASS satisfaction questionnaire; hospital length of stay (LOS), 90-d readmission, and return to work (RTW). Multivariable regression models were fitted for outcomes. RESULTS Of total 245 patients analyzed, 163 patients underwent anterior surgery (ACDF-116, ACCF-47) and 82 underwent posterior surgery. Patients undergoing an anterior approach had lower odds of having higher LOS (P < .001, odds ratio 0.16, 95% confidence interval 0.08-0.30). The 12-mo NDI, EQ-5D, NRS, mJOA, and satisfaction scores as well as 90-d readmission and RTW did not differ significantly between anterior and posterior groups. CONCLUSION Patients undergoing anterior approaches for 3 to 5 level degenerative cervical myelopathy had shorter hospital LOS compared to those undergoing posterior decompression and fusion. Also, patients in both groups exhibited similar long-term PROs, readmission, and RTW rates. Further investigations are needed to compare the differences in longer term reoperation rates and functional outcomes before the clinical superiority of one approach over the other can be established.

Background Survival and quality of life for patients affected by spinal muscular atrophy (SMA) are thought to have improved over the last decade due to changes in care. In addition, targeted treatments for SMA have been developed based on a better understanding of the molecular pathology. In 2016 and 2017, nusinersen was the first drug to be approved for treatment of all types of SMA in the United States and in Europe based on well-controlled clinical trials in a small subgroup of pediatric SMA patients. Systems are required to monitor treated and untreated SMA patients in a real-life environment to optimize treatment and care, and to provide outcome data to regulators, payers, and the SMA community. Methods Within SMArtCARE, we conduct a prospective, multicenter non-randomized registration and outcome study. SMArtCARE collects longitudinal data on all available SMA patients independent of their actual treatment regime as disease-specific SMA registry. For this purpose, we provide an online platform for SMA patients seen by health-care providers in Germany, Austria and Switzerland. All data are collected during routine patient visits. Items for data collection are aligned with the international consensus for SMA registries. Data analysis is carried out independent of commercial partners. Conclusion A prospective monitoring of all SMA patients will lead to a better understanding of the natural history of SMA and the influence of drug treatment. This is crucial to improve the care of SMA patients. Further, we will establish a network for neuromuscular centers to share experience with SMA patients and to promote research projects on SMA. Trial registration German Clinical Trials Register (“Deutsches Register klinischer Studien”) DRKS00012699. Registered 09 August 2018. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00012699 .

Purpose The purpose of this study was to investigate the impact of the type of data capture on the time and help needed for collecting patient-reported outcomes as well as on the proportion of missing scores. Methods In a multinational prospective study, thyroid cancer patients from 17 countries completed a validated questionnaire measuring quality of life. Electronic data capture was compared to the paper-based approach using multivariate logistic regression. Results A total of 437 patients were included, of whom 13% used electronic data capture. The relation between data capture and time needed was modified by the emotional functioning of the patients. Those with clinical impairments in that respect needed more time to complete the questionnaire when they used electronic data capture compared to paper and pencil (OR adj 24.0; p  = 0.006). This was not the case when patients had sub-threshold emotional problems (OR adj 1.9; p  = 0.48). The odds of having the researcher reading the questions out (instead of the patient doing this themselves) (OR adj 0.1; p  = 0.01) and of needing any help (OR adj 0.1; p  = 0.01) were lower when electronic data capture was used. The proportion of missing scores was equivalent in both groups (OR adj 0.4, p  = 0.42). Conclusions The advantages of electronic data capture, such as real-time assessment and fewer data entry errors, may come at the price of more time required for data collection when the patients have mental health problems. As this is not uncommon in thyroid cancer, researchers need to choose the type of data capture wisely for their particular research question.

Background Missing outcome data can pose a serious threat to the validity of randomised clinical trial results. We aimed to study the extent of missing outcome data in randomised clinical trials of psychological interventions. Methods We performed a retrospective study of randomised clinical trial reports of psychological interventions published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics from 2017 to 2022. We assessed the proportion of missing outcome data, whether missing data patterns differed between types of outcomes, participants, intervention lengths, and psychological intervention types, how missing outcome data were handled in the statistical analyses, and whether trialists discussed missing outcome data in the discussion section of the manuscript. Results We identified 182 randomised clinical trials (233 primary outcomes), of which 206 outcomes (88.4%) were assessed at high risk of bias due to missing data. The overall mean percentage of missing outcome data was 18.3% (95% confidence interval (CI): 16.7–20%) for all outcomes. The percentages of missing data were 18.9% (95% CI: 17.1–20.6%; 180 outcomes) for symptom severity scales and 1.8% (95% CI: 2.3–3.3%; 6 outcomes) for ‘hard’ binary outcomes. Trials including participants with borderline personality disorder had the highest percentage of missing outcome data (33.1%; 95% CI: 22.3–43.9%) compared with other psychiatric disorders. Fisher’s exact test showed that intervention lengths and psychological intervention types were associated with the proportion of missing outcome data ( p  < 0.001), but there were no clear patterns. Conclusion Missing outcome data is a considerable problem in randomised clinical trials of psychological interventions, and trialists should consider the corresponding methodological limitations in the design and analysis to reduce the risk of bias due to missing outcome data. Clinical trial registration number Not applicable.

To describe how systematic review authors report and address categories of participants with potential missing outcome data of trial participants. Methodological survey of systematic reviews reporting a group-level meta-analysis. We included a random sample of 50 Cochrane and 50 non-Cochrane systematic reviews. Of these, 25 reported in their methods section a plan to consider at least one of the 10 categories of missing outcome data; 42 reported in their results, data for at least one category of missing data. The most reported category in the methods and results sections was “unexplained loss to follow-up” (n = 34 in methods section and n = 6 in the results section). Only 19 reported a method to handle missing data in their primary analyses, which was most often complete case analysis. Few reviews (n = 9) reported in the methods section conducting sensitivity analysis to judge risk of bias associated with missing outcome data at the level of the meta-analysis; and only five of them presented the results of these analyses in the results section. Most systematic reviews do not explicitly report sufficient information on categories of trial participants with potential missing outcome data or address missing data in their primary analyses.