Applying the PTSD Checklist-Civilian and PTSD Checklist for DSM-5 crosswalk in a traumatic brain injury sample: A veterans affairs traumatic brain injury model systems study.

This study evaluates the use of the crosswalk between the PTSD Checklist-Civilian (PCL-C) and PTSD Checklist for DSM-5 (PCL-5) designed by Moshier et al. (2019) in a sample of service members and veterans (SM/V; N = 298) who had sustained a traumatic brain injury (TBI) and were receiving inpatient rehabilitation. The PCL-C and PCL-5 were completed at the same time. Predicted PCL-5 scores for the sample were obtained according to the crosswalk developed by Moshier et al. We used three measures of agreement: intraclass correlation coefficient (ICC), mean difference between predicted and observed scores, and Cohen's κ to determine the performance of the crosswalk in this sample. Subgroups relevant to those who have sustained a TBI, such as TBI severity, were also examined. There was strong agreement between the predicted and observed PCL-5 scores (ICC = .95). The overall mean difference between predicted and observed PCL-5 scores was 0.07 and not statistically significant (SD = 8.29, p = .89). Significant mean differences between predicted and observed PCL-5 scores calculated between subgroups were seen in Black participants (MD = -4.09, SD = 8.41, p = .01) and those in the Year 5 follow-up group (MD = 1.77, SD = 7.14, p = .03). Cohen's κ across subgroups had a mean of κ = 0.76 (.57-1.0), suggesting that there was moderate to almost perfect diagnostic agreement. Our results suggest the crosswalk created by Moshier et al. can be applied to SM/V who have suffered a TBI. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

A systematic critical appraisal of clinical practice guidelines of antithrombotic agents in gastrointestinal endoscopy using the AGREE II tool.

BACKGROUND AND AIM: The quality of clinical practice guidelines (CPGs) for the management of antithrombotic agents in patients undergoing gastrointestinal (GI) endoscopy has not been systematically appraised. The goal of this study was to evaluate the methodological quality of CPGs for the management of antithrombotic agents in periendoscopic period published within last 6 years. METHODS: A systematic search of PubMed and Embase databases was performed to identify eligible CPGs published between January 1, 2016, and April 14, 2022, addressing the management of antithrombotic agents in the periendoscopic period. The quality of the CPG was independently assessed by six reviewers using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Domain scores were considered of sufficient quality when > 60% and of good quality when > 80%. RESULTS: The search yielded 343 citations, of which seven CPGs published by the gastroenterology associations in Asia (n = 3), Europe (n = 2), and North America (n = 2) were included for the critical appraisal. The overall median score for the AGREE II domains was 93% (interquartile range [IQR] 11%) for scope and purpose, 79% (IQR 61%) for stakeholder involvement, 79% (IQR 36%) for rigor of development, 100% (IQR 14%) for clarity of presentation, 32% (IQR 36%) for applicability, 93% (IQR 29%) for editorial independence, and 86% (IQR 29%) for overall assessment. CONCLUSIONS: The findings show that the overall methodological quality of the CPGs for the management of antithrombotic agents in the periendoscopic period varies across the domains. There is significant scope for improvement in the methodological rigor and applicability of CPGs.

Enhanced recovery protocol after cesarean delivery: impact on opioid use and pain perception.

BACKGROUND: Opioids are routinely prescribed to patients postoperatively after cesarean delivery. With rates of cesarean deliveries increasing globally and the opioid epidemic continuing to have deleterious effects, finding methods to achieve effective pain control without opioids is of increasing importance. The ERAS (Enhanced Recovery After Surgery) protocol applied following cesarean delivery engages multimodal perioperative management techniques to encourage early recovery. In the obstetrical surgery setting, these interventions include increasing scheduled nonsteroidal anti-inflammatory drug administration and laxative use to improve postoperative gastrointestinal motility and pain scores. Postcesarean patients are also encouraged to use abdominal binders, incentive spirometry, and early movement as pain modulators. OBJECTIVE: This quality improvement study aimed to measure whether the introduction of an ERAS protocol following cesarean delivery at a United States-based health network would improve outcomes such as the use of opioid medications for pain and pain control. STUDY DESIGN: This single-center retrospective cohort study compared patients who gave birth via cesarean delivery before (n=1425) and after (n=3478) the implementation of the postsurgical recovery protocol. Outcomes of interest included total postoperative opioid medications used, discharge opioid prescription, average pain score, pain scores by postoperative day, and highest pain score. Patients with a history of opioid use disorder, those who underwent a cesarean hysterectomy, and those who experienced a major surgical complication at delivery were excluded. Data were collected from the electronic medical record. RESULTS: Patients in the postimplementation period used significantly fewer opioid medications than those who gave birth before the protocol was introduced at the institution. The total median opioid use before implementation was 75 morphine milligram equivalents (interquartile range, 45-112.5) vs 30 (interquartile range, 15-52.5) after implementation (P<.001). The median discharge prescription was 225 (interquartile range, 150-225) before implementation vs 112.5 (interquartile range, 75-150) after implementation (P<.001). Pain scores were also significantly lower after implementation. The median highest pain score was 8 (interquartile range, 6-8) on a 10-point pain scale before implementation vs 7 (interquartile range, 6-8) after implementation (P<.001). The average pain score before implementation was 3.4 (interquartile range, 2.4-4.5) vs 2.9 (interquartile range, 1.9-3.9) after implementation (P<.001). Results of paired-sample analyses of 177 patients who gave birth by cesarean delivery in both time periods showed statistically significant outcomes similar to those of the larger cohort groups. CONCLUSION: Implementation of multimodal pain regimens following cesarean delivery, such as the ERAS protocol, which incorporate both pharmacologic (nonsteroidal anti-inflammatory drugs, laxatives) and nonpharmacologic methods (abdominal binders, deep breathing, movement) can be effective for pain control and may decrease postoperative opioid prescribing needs, thus mitigating the potential for opioid misuse and dependence.

Alternative Structure Models of the Traumatic Brain Injury Rehabilitation Needs Survey: A Veterans Affairs TBI Model Systems Study.

OBJECTIVE: To explore the factor structure of the Rehabilitation Needs Survey (RNS). DESIGN: Secondary analysis of observational cohort study who were 5-years post-traumatic brain injury (TBI). SETTING: Five Inpatient Rehabilitation Facilities. PARTICIPANTS: Veterans enrolled in the TBI Model Systems longitudinal study who completed the RNS at 5-year follow-up (N=378). MAIN OUTCOME MEASURE(S): RNS. RESULTS: RNS factor structure was examined with exploratory factor analysis (EFA) with oblique rotation. Analyses returned 2- and 3-factor solutions with Cronbach alphas ranging from 0.715 to 0.905 and corrected item-total correlations that ranged from 0.279 to 0.732. The 2-factor solution accounted for 61.7% of the variance with ≥3 exclusively loading items on each factor with acceptable internal consistency metrics and was selected as the most parsimonious and clinically applicable model. Ad hoc analysis found the RNS structure per the EFA corresponded with elements of the International Classification of Functioning, Disability and Health (ICF) conceptual framework. All factors had adequate internal consistency (α≥0.70) and 20 of the 21 demonstrated good discrimination (corrected item-total correlations≥0.40). CONCLUSIONS: The 2-factor solution of the RNS appears to be a useful model for enhancing its clinical interpretability. Although there were cross-loading items, they refer to complex rehabilitation needs that are likely influenced by multiple factors. Alternatively, there are items that may require alteration and redundant items that should be considered for elimination.

Comparative Benefits and Risks Associated with Currently Authorized COVID-19 Vaccines.

This article provides a systematic assessment of the efficacy, risks, and methodological quality of evidence from five major publicly available vaccine trials. Results from Pfizer-BioNTech mRNA, Moderna-US NIH mRN-1273, AstraZeneca-Oxford ChAdOx1 nCov-19, Gamaleya GamCovidVac (Sputnik V), and Ad26.COV2.S Johnson & Johnson vaccines were included. Extracted benefits and risks data from each trial were summarized using the GRADE approach denoting the overall certainty of evidence along with relative and absolute effects. Relative risk reduction across all five vaccine trials ranged from 45% to 96%. Absolute risk reduction in symptomatic COVID-19 ranged from 6 to 17 per 1000 across trials. None of the vaccines were associated with a significant increase in serious adverse events compared to placebo. The overall certainty of evidence varied from low to moderate. All five vaccines are effective and safe, but suggest room for improvement in the conduct of large-scale vaccine trials. Certainty of evidence was downrated due to risk of bias, which can be mitigated by improving transparency and thoroughness in conduct and reporting of outcomes.

Family Needs After Traumatic Brain Injury: A VA TBI Model Systems Study.

OBJECTIVE: To describe the self-reported needs of family caregivers of service members and veterans (SMVs) who sustained a traumatic brain injury (TBI) and to identify predictors of the unmet family caregiver needs. SETTING: Five Department of Veterans Affairs (VA) Polytrauma Rehabilitation Centers (PRCs). PARTICIPANTS: Family caregivers of SMVs enrolled in the VA PRC TBI Model Systems (TBIMS) national database who were within their first 5 years post-TBI ( n = 427). DESIGN: Observational study. MAIN OUTCOME MEASURE: The Family Needs Questionnaire-Revised (FNQ-R) was completed by each SMV's designated caregiver. ANALYSES: Descriptive analyses were conducted on the FNQ-R responses at the item, domain, and total score levels. Unadjusted univariable and adjusted multivariable regression models were fitted to identify predictors of total unmet needs and unmet family need domains. RESULTS: FNQ-R item-level and domain-level descriptive results indicated that health information was the most frequently met need domain. In contrast, emotional and instrumental support domains were the least often met. On average, family caregivers reported that 59.2% of the 37 FNQ-R needs were met at the time of the follow-up assessment. Regression models indicated that both the number of SMV-perceived environmental barriers and whether the SMV received mental health treatment within the past year predicted the number of unmet FNQ-R needs. SMV-reported environmental barriers predicted increased unmet needs in all 6 family caregiver domains, and SMV mental health treatment in the past year predicted more unmet family caregiver emotional support, community support, and professional support needs. CONCLUSIONS: The current findings can be used to inform policy and programming for VA and Department of Defense to proactively address the specific needs of families and caregivers experienced in the first 5 years post-TBI.

Perception of Medical Student Mistreatment: Does Specialty Matter?

PURPOSE: Medical student mistreatment is pervasive, yet whether all physicians have a shared understanding of the problem is unclear. The authors presented professionally designed trigger videos to physicians from 6 different specialties to determine if they perceive mistreatment and its severity similarly. METHOD: From October 2016 to August 2018, resident and attending physicians from 10 U.S. medical schools viewed 5 trigger videos showing behaviors that could be perceived as mistreatment. They completed a survey exploring their perceptions. The authors compared perceptions of mistreatment across specialties and, for each scenario, evaluated the relationship between specialty and perception of mistreatment. RESULTS: Six-hundred fifty resident and attending physicians participated. There were statistically significant differences in perception of mistreatment across specialties for 3 of the 5 scenarios: aggressive questioning (range, 74.1%-91.2%), negative feedback (range, 25.4%-63.7%), and assignment of inappropriate tasks (range, 5.5%-25.5%) (P ≤ .001, for all). After adjusting for gender, race, professional role, and prior mistreatment, physicians in surgery viewed 3 scenarios (aggressive questioning, negative feedback, and inappropriate tasks) as less likely to represent mistreatment compared with internal medicine physicians. Physicians from obstetrics-gynecology and "other" specialties perceived less mistreatment in 2 scenarios (aggressive questioning and negative feedback), while family physicians perceived more mistreatment in 1 scenario (negative feedback) compared with internal medicine physicians. The mean severity of perceived mistreatment on a 1 to 7 scale (7 most serious) also varied statistically significantly across the specialties for 3 scenarios: aggressive questioning (range, 4.4-5.4; P < .001), ethnic insensitivity (range, 5.1-6.1; P = .001), and sexual harassment (range, 5.5-6.3; P = .004). CONCLUSIONS: Specialty was associated with differences in the perception of mistreatment and rating of its severity. Further investigation is needed to understand why these perceptions of mistreatment vary among specialties and how to address these differences.

Association of pharmacist counseling with adherence, 30-day readmission, and mortality: A systematic review and meta-analysis of randomized trials.

OBJECTIVE(S): To determine the association of pharmacist medication counseling with medication adherence, 30-day hospital readmission, and mortality. METHODS: The initial search identified 21,590 citations. After applying the inclusion and exclusion criteria, 62 randomized controlled trials (RCTs) (49 for the meta-analysis) were included in the final analysis. Data were pooled using a random-effects model. RESULTS: The participants in most of the studies were older patients with chronic diseases who, therefore, were taking many drugs. The overall methodologic quality of evidence ranged from low to very low. Pharmacist medication counseling versus no such counseling was associated with a statistically significant 30% increase in relative risk (RR) for medication adherence, a 24% RR reduction in 30-day hospital readmission (number needed to treat = 4.2), and a 30% RR reduction in emergency department visits. RR reductions for primary care visits and mortality were not statistically significant. CONCLUSION: The evidence supports pharmacist medication counseling to increase medication adherence and to reduce 30-day hospital readmissions and emergency department visits. However, higher-quality RCT studies are needed to confirm or refute these findings.

Unmet Rehabilitation Needs Indirectly Influence Life Satisfaction 5 Years After Traumatic Brain Injury: A Veterans Affairs TBI Model Systems Study.

OBJECTIVE: To describe the association between unmet rehabilitation needs and life satisfaction 5 years after traumatic brain injury (TBI). DESIGN: Prospective observational cohort. SETTING: Five Veterans Affairs (VA) Polytrauma Rehabilitation Centers. PARTICIPANTS: VA TBI Model Systems participants (N=301); 95% male; 77% white; average age, 39±14y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Satisfaction With Life Scale (SWLS). RESULTS: Average SWLS score was 22±8. Univariable analyses demonstrated several statistically significant predictors of life satisfaction, including employment status, participation, psychiatric symptom severity, past year mental health treatment, and total number of unmet rehabilitation needs (all P<.05). Multivariable analyses revealed that depression and participation were each associated with life satisfaction. An ad hoc mediation model suggested that unmet rehabilitation needs total was indirectly related to life satisfaction. Total unmet rehabilitation needs ranged from 0-21 (mean, 2.0±3.4). Correlational analyses showed that 14 of the 21 unmet rehabilitation needs were associated with life satisfaction. CONCLUSIONS: Findings support the need for rehabilitation engagement in later stages of TBI recovery. Ongoing assessment of and intervention for unmet rehabilitation needs in the chronic phase of recovery have the potential to mitigate decline in life satisfaction.

A prospective, head-to-head comparison of 2 EUS-guided liver biopsy needles in vivo.

BACKGROUND AND AIMS: Procedural standardization in endoscopic ultrasound-guided liver biopsy (EUS-LB) is necessary to obtain core biopsy specimens for accurate diagnosis. The objective of this study was to directly compare the diagnostic yield of 2 EUS-LB fine-needle biopsy (FNB) systems in vivo. METHODS: In this prospective, single-center study, 108 adult patients undergoing EUS-LB over a 1-year period were included. Each EUS-LB consisted of an EGD, followed by EUS-guided biopsy of the left lobe of the liver sequentially using 2 different 19-gauge needles: the fork-tip (SharkCore) and Franseen (Acquire) FNB systems. Specimens were then reviewed by a GI histopathologist to determine diagnostic adequacy as well as the number of complete portal tracts, specimen length, and degree of fragmentation. RESULTS: In 79.4% of cases, the fork-tip FNB system yielded a final diagnosis compared with 97.2% of the Franseen FNB specimens (P < .001). The mean number of complete portal tracts in the fork-tip FNB samples was 7.07 compared with 9.59 in the Franseen FNB samples (P < .001). The mean specimen length was 13.86 mm for the fork-tip FNB and 15.81 mm for the Franseen FNB (P = .004). Cores were intact in 47.6% of the fork-tip FNB samples and in 75.2% of the Franseen FNB samples (P = .004). CONCLUSIONS: In EUS-LB, we found that the 19-gauge Franseen FNB system resulted in a statistically significant increase in diagnostic adequacy compared with biopsy using the fork-tip FNB system.

Clinical Factors and Outcomes of Octogenarians Receiving Curative Surgery for Esophageal Cancer.

BACKGROUND: The incidence of esophageal cancer is increasing in the United States. Although neoadjuvant therapy (NAT) for locally advanced cancers followed by surgical resection is the standard of care, there are no clearly defined guidelines for patients aged ≥79 y. METHODS: Query of an institutional review board-approved database of 1031 esophagectomies at our institution revealed 35 patients aged ≥79 y from 1999 to 2017 who underwent esophagectomy. Age, gender, tumor location, histology, clinical stage, Charlson Comorbidity Index (CCI), NAT administration, pathologic response rate to NAT, surgery type, negative margin resection status, postoperative complications, postoperative death, length of stay, 30- and 90-d mortality, and disease status parameters were analyzed in association with clinical outcome. RESULTS: The median age of the octogenarian cohort was 82.1 y with a male preponderance (91.4%). American Joint Committee on Cancer clinical staging was stage I for 20% of patients, stage II for 27% of patients, and stage III for 50% of patients, which was not statistically significant compared with the younger cohort (P = 0.576). Within the octogenarian group, 54% received NAT compared with 67% in the younger group (P = 0.098). There was no difference in postoperative complications (P = 0.424), postoperative death (P = 0.312), and recurrence rate (P = 0.434) between the groups. However, CCI was significantly different between the octogenarian and nonoctogenarian cohort (P = 0.008), and octogenarians had shorter overall survival (18 versus 62 mo, P<0.001). None of the other parameters assessed were associated with clinical outcomes. CONCLUSIONS: Curative surgery is viable and safe for octogenarians with esophageal cancer. Long-term survival was significantly shorter in the octogenarian group, suggesting the need for better clinical selection criteria for esophagectomy after chemoradiation and that identification of complete responders for nonoperative management is warranted.

Clinical factors associated with the development of postoperative atrial fibrillation in esophageal cancer patients receiving multimodality therapy before surgery.

BACKGROUND: The incidence of esophageal cancer (EC) is increasing in the USA. Neoadjuvant therapy for locally advanced cancers followed by surgical resection is the standard of care. The most common post-esophagectomy cardiac complication is atrial fibrillation (AF). New-onset postoperative AF can require a prolonged hospital stay and may confer an overall poorer prognosis. In this study, we seek to identify clinical factors associated with postoperative AF. METHODS: Query of an IRB approved database of 1,039 esophagectomies at our institution revealed 677 patients with EC from 1999 to 2017 who underwent esophagectomy after neoadjuvant treatment. Age, treatment location (primary vs. other), gender, neoadjuvant radiation type [2D vs. 3D vs. intensity modulated radiation therapy (IMRT)], radiation dose, surgery type (transthoracic vs. transhiatal vs. three field), smoking history, coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), operative time, blood transfusions, fluid management, and length of stay (LOS) were analyzed in relationship to the development of AF. Statistical analysis was performed with SPSS 24. RESULTS: The mean age of the entire cohort was 64.3 (range, 28-86 years), with a Caucasian and male preponderance (White: 94.5%; male: 83.6%). Of the 677 patients, 14.9% (n=101) developed postoperative AF. Increasing age (P<0.001), increased radiation dose (P=0.034), operative time (P=0.001), and blood transfusions (P=0.027) were associated with AF. LOS was longer in patients with AF than those without AF (10.5 vs. 10.0 days, P=0.001). On multivariate analysis, increasing age (95% CI: 1.023-1.080, P<0.001) and radiation dose (95% CI: 1.000-1.001, P=0.034) remained significant. None of the other parameters assessed were associated with the development of AF. CONCLUSIONS: Increasing age and radiation dose were associated with the development of postoperative AF in this cohort. This study suggests that older patients or patients receiving higher radiation dose should be monitored more closely in the postoperative setting and potentially referred earlier preoperatively for cardio-oncology assessment. Future study is required to determine if modification of current radiation techniques and cardiac dose constraints in this patient population may be warranted.

Exploring Perspectives from Internal Medicine Clerkship Directors in the USA on Effective Narrative Evaluation: Results from the CDIM National Survey.

PURPOSE: Clinical performance evaluations play a critical role in determining medical school clerkship grades. This study aimed to provide clarification from clerkship directors in internal medicine on what constitutes an effective and informative narrative description of student performance. METHODS: In September 2016, the Clerkship Directors in Internal Medicine (CDIM) electronically administered its annual, voluntary, and confidential cross-sectional survey of its US membership. One section of the survey asked six questions regarding the helpful components of an effective narrative evaluation. Respondents were asked to rate the effectiveness of elements contained within narrative evaluations of students. RESULTS: Ninety-five CDIM members responded to the survey with an overall response rate of 74.2%. Descriptions of skills and behaviors were felt to be the most important, followed by a description of the overall synthetic or global assessment level of the student. Descriptions of personality and attitude were the next highest rated feature followed by adjectives describing performance. Length was felt to be the least important component. In free-text comments, several respondents indicated that direct observation of performance and specific examples of skills and behaviors are also desirable. CONCLUSIONS: Narrative evaluations of students that explicitly comment on skills, behaviors, and an overarching performance level of the learner are strongly preferred by clerkship directors. Direct observation of clinical performance and giving specific examples of such behaviors give evaluations even more importance. Faculty development on evaluation and assessment should include instruction on these narrative assessment characteristics.

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

Importance: The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown. Objectives: To determine how often the FDA has authorized novel interventions based on non-RCTs and to assess whether there is an association of the magnitude of treatment effects with FDA requirements for additional testing in randomized clinical trials (RCTs). Data Sources: Overall, 606 drug applications for the Breakthrough Therapy designation from its inception in January 2012 were downloaded from the FDA website in January 2017 and August 2018, and 71 medical device applications for the Humanitarian Device Exemption from its inception in June 1996 were downloaded in August 2017. Study Selection: Approved applications based on non-RCTs were included; RCTs, studies with insufficient information, duplicates, and safety data were excluded. Data Extraction and Synthesis: Data were extracted by 2 independent investigators. A statistical association of the magnitude of estimated effect (expressed as an odds ratio) with FDA requests for RCTs was assessed. The data were also meta-analyzed to evaluate the differences in odds ratios between applications that required further testing and those that did not. The results are reported according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Main Outcomes and Measures: Disease, laboratory, and patient-related outcomes, including disease response or patient survival, were considered. Results: Among 677 drug and medical device applications, 68 (10.0%) were approved by the FDA based on non-RCTs. Estimates of effects were larger when no further RCTs were required (mean natural logarithm of the odds ratios, 2.18 vs 1.12; odds ratios, 8.85 vs 3.06; P = .03). The meta-analysis results confirmed these findings: estimated effects were approximately 2.5-fold higher for treatments or devices that were approved based on non-RCTs than for treatments or devices for which further testing in RCTs was required (6.30 [95% CI, 4.38-9.06] vs 2.46 [95% CI, 1.70-3.56]; P < .001). Overall, 9 of 677 total applications (1.3%) that were approved on the basis of non-RCTs had relative risks of 10 or greater and 12 (1.7%) had relative risks of 5 or greater. No clear threshold above which the FDA approved interventions based on the magnitude of estimated effect alone was detected. Conclusions and Relevance: In this study, estimated magnitudes of effect were larger among studies for which the FDA did not require RCTs compared with studies for which it did. There was no clear threshold of treatment effect above which no RCTs were requested.

Efficacy of Allogeneic Hematopoietic Cell Transplantation in Human T Cell Lymphotropic Virus Type 1-Associated Adult T Cell Leukemia/Lymphoma: Results of a Systematic Review/Meta-Analysis.

Human T cell lymphotropic virus type 1 (HTLV1)-associated adult T cell leukemia/lymphoma (ATLL) is an aggressive malignant disorder. Intensive conventional chemotherapy regimens and autologous hematopoietic cell transplantation (HCT) have failed to improve outcomes in ATLL. Allogeneic HCT (allo-HCT) is commonly offered as front-line consolidation despite lack of randomized controlled trials. We performed a comprehensive search of the medical literature using PubMed/Medline, EMBASE, and Cochrane reviews on September 10, 2018. We extracted data on clinical outcomes related to benefits (complete response [CR], overall survival [OS], and progression-free survival [PFS]) and harms (relapse and nonrelapse mortality [NRM]), independently by 2 authors. Our search strategy identified a total of 801 references. Nineteen studies (n = 2446 patients) were included in the systematic review; however, only 18 studies (n = 1767 patients) were included in the meta-analysis. Reduced intensity conditioning regimens were more commonly prescribed (52%). Bone marrow (50%) and peripheral blood (40%) were more frequently used as stem cell source. The pooled post-allografting CR, OS, and PFS rates were 73% (95% confidence interval [CI], 57% to 87%), 40% (95% CI, 33% to 46%), and 37% (95% CI, 27% to 48%), respectively. Pooled relapse and NRM rates were 36% (95% CI, 28% to 43%) and 29% (95% CI, 21% to 37%), respectively. The heterogeneity among the included studies was generally high. These results support the use of allo-HCT as an effective treatment for patients with ATLL, yielding pooled OS rates of 40%, but relapse still occurs in over one-third of cases. Future studies should evaluate strategies to help reduce relapse in patients with ATLL undergoing allo-HCT.

Medical Student Mistreatment-an Obstetrics and Gynecology Perspective: a Pilot Study.

OBJECTIVE: To determine if perception of mistreatment and severity in each of the professional videotaped vignettes was similar between participants of differing professional status (Ob/Gyn attending physicians, resident physicians, and medical students), previous mistreatment status, ethnic minority status, and gender. METHODS: Three video vignettes were filmed portraying possible medical student mistreatment during an obstetrics and gynecology clerkship. Prior to watching the videos, all participants were asked to complete a questionnaire related to their prior experience with mistreatment as a medical student along with other demographic details. After viewing each video, participants were asked to rate the video as representing mistreatment (yes/no) and, if yes, the severity of medical student mistreatment. RESULTS: Eight attending physicians, ten resident physicians, and ten medical students participated in this study. Professional status, previous mistreatment status, ethnic minority status, and gender did not affect how participants perceived mistreatment or the severity of the video vignettes. Fifty percent (14/28) of participants reported previous mistreatment as a medical student, all of which occurred during their third year of medical school. CONCLUSION: Medical students, resident physicians, and attending physicians generally agreed which video vignettes represented medical student mistreatment and the level of severity of the event.

Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval.

OBJECTIVES: The aim of this study was to evaluate how often the European Medicines Agency (EMA) has authorized drugs based on nonrandomized studies and whether there is an association between treatment effects and EMA preference for further testing in randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: We reviewed all initial marketing authorizations in the EMA database on human medicines between 1995 and 2015 and included authorizations granted without randomized data. We extracted data on treatment effects and EMA preference for further testing in RCTs. RESULTS: Of 723 drugs, 51 were authorized based on nonrandomized data. These 51 drugs were licensed for 71 indications. In the 51 drug-indication pairs with no preference for further RCT testing, effect estimates were large [odds ratio (OR): 12.0 (95% confidence interval {CI}: 8.1-17.9)] compared to effect estimates in the 20 drug-indication pairs for which future RCTs were preferred [OR: 4.3 (95% CI 2.8-6.6)], with a significant difference between effects (P = 0.0005). CONCLUSION: Nonrandomized data were used for 7% of EMA drug approvals. Larger effect sizes were associated with greater likelihood of approval based on nonrandomized data alone. We did not find a clear treatment effect threshold for drug approval without RCT evidence.

Treatment targeted at underlying disease versus palliative care in terminally ill patients: a systematic review.

OBJECTIVE: To assess the efficacy of active treatment targeted at underlying disease (TTD)/potentially curative treatments versus palliative care (PC) in improving overall survival (OS) in terminally ill patients. DESIGN: We performed a systematic review and meta-analysis of randomised controlled trials (RCT). Methodological quality of included RCTs was assessed using the Cochrane risk of bias tool. DATA SOURCES: Medline and Cochrane databases were searched, with no language restriction, from inception to 19 October 2016. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Any RCT assessing the efficacy of any active TTD versus PC in adult patients with terminal illness with a prognosis of <6-month survival were eligible for inclusion. RESULTS: Initial search identified 8252 citations of which 10 RCTs (15 comparisons, 1549 patients) met inclusion criteria. All RCTs included patients with cancer. OS was reported in 7 RCTs (8 comparisons, 1158 patients). The pooled results showed no statistically significant difference in OS between TTD and PC (HR (95% CI) 0.85 (0.71 to 1.02)). The heterogeneity between pooled studies was high (I2=62.1%). Overall rates of adverse events were higher in the TTD arm. CONCLUSIONS: Our systematic review of available RCTs in patients with terminal illness due to cancer shows that TTD compared with PC did not demonstrably impact OS and is associated with increased toxicity. The results provide assurance to physicians, patients and family that the patients' survival will not be compromised by referral to hospice with focus on PC.