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To describe the association between unmet rehabilitation needs and life satisfaction 5 years after traumatic brain injury (TBI).Prospective observational cohort.Five Veterans Affairs (VA) Polytrauma Rehabilitation Centers.VA TBI Model Systems participants (N=301); 95% male; 77% white; average age, 39±14y).Not applicable.Satisfaction With Life Scale (SWLS).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.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.

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.

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.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.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).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.

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.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).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.Approved applications based on non-RCTs were included; RCTs, studies with insufficient information, duplicates, and safety data were excluded.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.Disease, laboratory, and patient-related outcomes, including disease response or patient survival, were considered.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.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.

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.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.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, P0.001). None of the other parameters assessed were associated with clinical outcomes.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.

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.

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