Psychometric Properties of Functional, Ambulatory, and Quality of Life Instruments in Lower Limb Amputees: A Systematic Review.

OBJECTIVE: Summarize the psychometric properties of functional, ambulatory, and quality of life instruments among adult lower limb amputees, highlighting evidence deemed generalizable to the United States Medicare population. DATA SOURCES: Six databases and existing systematic reviews through October 30, 2017. Searches included terms for lower limb amputation or prostheses and outcome measures in humans, without language restriction. STUDY SELECTION: We included peer-reviewed studies of at least 20 adults (≥18 years) with lower limb amputation. Eligible studies reported on psychometric properties of functional, ambulatory, or quality of life instruments. Fifty-three of 425 retrieved articles (12%) met criteria. DATA EXTRACTION: Study characteristics and psychometric property data (validity, reliability, responsiveness, minimum detectable change, minimal important difference, or floor or ceiling effect) were extracted into a customized form based on standardized criteria. All extracted data were confirmed by 2 experts in systematic review and rehabilitation outcome measurement. Instruments were categorized regarding having been validated and found reliable. Other reported psychometric properties were recorded. Studies were also assessed for applicability to the Medicare population based on age and amputation etiology (dysvascular). DATA SYNTHESIS: Fifty-six studies (in 53 articles) reported psychometric properties of 50 instruments. There is evidence for both validity and reliability for 30 instruments, 17 of which have evidence that was deemed generalizable to the Medicare population. Most of the remaining instruments have evidence of either validity or reliability, but not both. Twelve instruments have been assessed specifically among lower limb amputees prior to prosthesis prescription. Thirteen instruments have been assessed regarding their predictive properties for future outcomes. CONCLUSIONS: Numerous instruments assessing ambulation, function, quality of life, and other patient-centered outcomes have evidence of validity and reliability for adults with lower limb amputations. Researchers and clinicians should use validated, reliable instruments when feasible. Many existing and new instruments require validation for use with lower limb amputees.

Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis.

Background: Most interventions for basal cell carcinoma (BCC) have not been compared in head-to-head randomized trials. Purpose: To evaluate the comparative effectiveness and safety of treatments of primary BCC in adults. Data Sources: English-language searches of MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Embase from inception to May 2018; reference lists of guidelines and systematic reviews; and a search of ClinicalTrials.gov in August 2016. Study Selection: Comparative studies of treatments currently used in adults with primary BCC. Data Extraction: One investigator extracted data on recurrence, histologic clearance, clinical clearance, cosmetic outcomes, quality of life, and mortality, and a second reviewer verified extractions. Several investigators evaluated risk of bias for each study. Data Synthesis: Forty randomized trials and 5 nonrandomized studies compared 18 interventions in 9 categories. Relative intervention effects and mean outcome frequencies were estimated using frequentist network meta-analyses. Estimated recurrence rates were similar for excision (3.8% [95% CI, 1.5% to 9.5%]), Mohs surgery (3.8% [CI, 0.7% to 18.2%]), curettage and diathermy (6.9% [CI, 0.9% to 36.6%]), and external-beam radiation (3.5% [CI, 0.7% to 16.8%]). Recurrence rates were higher for cryotherapy (22.3% [CI, 10.2% to 42.0%]), curettage and cryotherapy (19.9% [CI, 4.6% to 56.1%]), 5-fluorouracil (18.8% [CI, 10.1% to 32.5%]), imiquimod (14.1% [CI, 5.4% to 32.4%]), and photodynamic therapy using methyl-aminolevulinic acid (18.8% [CI, 10.1% to 32.5%]) or aminolevulinic acid (16.6% [CI, 7.5% to 32.8%]). The proportion of patients reporting good or better cosmetic outcomes was better for photodynamic therapy using methyl-aminolevulinic acid (93.8% [CI, 79.2% to 98.3%]) or aminolevulinic acid (95.8% [CI, 84.2% to 99.0%]) than for excision (77.8% [CI, 44.8% to 93.8%]) or cryotherapy (51.1% [CI, 15.8% to 85.4%]). Data on quality of life and mortality were too sparse for quantitative synthesis. Limitation: Data are sparse, and effect estimates are imprecise and informed by indirect comparisons. Conclusion: Surgical treatments and external-beam radiation have low recurrence rates for the treatment of low-risk BCC, but substantial uncertainty exists about their comparative effectiveness versus other treatments. Gaps remain regarding high-risk BCC subtypes and important outcomes, including costs. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42016043353).

Comparison of once and twice daily radiotherapy for limited stage small-cell lung cancer.

PURPOSE: This study was designed to review outcomes of once- (QD) versus twice-daily (BID) radiotherapy (RT) for limited stage small-cell lung cancer (L-SCLC) treated at Dana-Farber Cancer Institute/Brigham and Women's Hospital. METHODS: We reviewed records for all patients with L-SCLC treated with radical chemoradiotherapy at our institution between January 2005 and December 2010. Differences in patient, tumor, and treatment characteristics were assessed by Student's t test and Fisher exact test. Outcomes were compared using Kaplan-Meier estimates and Cox proportional hazards regression. RESULTS: Twenty patients received QD RT to a median dose of 61.2 Gy, and 26 patients received BID RT to a dose of 45 Gy. Median follow-up was 2.8 years. Overall survival (OS) was similar in both groups. 5-year locoregional control (LC) for all patients was 67 %: 80 % for the QD group and 57 % for the BID group (log-rank, P = 0.16). Grade 2 or higher dermatitis and pneumonitis were significantly higher in the QD group (15 vs. 0 %, P = 0.0014 and 13 vs. 4 %, P = 0.048, respectively), whereas Grade 2 or higher esophagitis trended higher in the BID group (44 vs. 24 %, P = 0.076). CONCLUSIONS: Although there were no differences in OS with QD versus BID RT, there was a trend toward increased LC in the QD group. Dermatitis and pneumonitis were more common for QD RT, and esophagitis was somewhat more common for BID RT. Possible differences in toxicities depending on RT regimen may be worth further investigation, until results from CALGB 30610 become available.

Comparative Effectiveness and Safety of Bariatric Procedures in Medicare-Eligible Patients: A Systematic Review.

Importance: The prevalence of obesity in patients older than 65 years is increasing. A substantial number of beneficiaries covered by Medicare meet eligibility criteria for bariatric procedures. Objective: To assess the comparative effectiveness and safety of bariatric procedures in the Medicare-eligible population. Evidence Review: This systematic review was conducted according to the PRISMA guidelines. Articles were identified through searches of PubMed, Embase, CINAHL, PsycINFO, Cochrane Central Trials Registry, Cochrane Database of Systematic Reviews, and scientific information packages from manufacturers, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and US Food and Drug Administration drugs and devices portals from January 1, 2000, to June 31, 2017. Randomized and nonrandomized comparative studies that evaluated bariatric procedures in the Medicare-eligible population were eligible. Six researchers extracted data on design, interventions, outcomes, and study quality. Findings were synthesized qualitatively; a planned meta-analysis was not undertaken owing to clinical heterogeneity. Findings: A total of 11 455 citations were screened for eligibility. Of those, 16 met the eligibility criteria. Compared with no surgery or conventional weight-loss treatment, bariatric surgery results in greater weight loss. Overall mortality after 30 days is lower among bariatric patients (hazard ratio, HR, 0.50; 95% CI, 0.31-0.79, in the study with the longest follow-up of 5.9 years), although, based on 1 study, mortality within 30 days of surgery was higher than in nonsurgically treated controls (1.55% vs 0.53%; P < .001). Bariatric surgery is associated with lower risk of cardiovascular disease (HR, 0.59; 95% CI, 0.44-0.79 in the largest study comparison) and with improvements in respiratory, musculoskeletal, metabolic, and renal outcomes (increase in estimated glomerular filtration rate, 9.84; 95% CI, 8.05-11.62 mL/min/1.73m2). Compared with sleeve gastrectomy (SG) and adjustable gastric banding (AGB), Roux-en-Y gastric bypass (RYGB) appears to be associated with greater weight loss (percent excess weight loss, 23.8% [95% CI, 16.2%-31.4%] at the longest follow-up of 4 years) but the 3 procedures have similar associations with most non-weight loss outcomes. Overall postoperative complications are not statistically significantly different between RYGB and SG, although major and/or serious complications are more common after RYGB. However, these associations are susceptible to at least moderate risk of confounding, selection, or measurement biases. Conclusions and Relevance: In the Medicare population, there is low to moderate strength of evidence that bariatric surgery as a weight loss treatment improves non-weight loss outcomes. Well-designed comparative studies are needed to credibly determine the treatment effects for bariatric procedures in this patient population.