Within-Trial Cost-Effectiveness of a Structured Lifestyle Intervention in Adults With Overweight/Obesity and Type 2 Diabetes: Results From the Action for Health in Diabetes (Look AHEAD) Study.

OBJECTIVE: To assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study. RESEARCH DESIGN AND METHODS: Data were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars. RESULTS: Over the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT. CONCLUSIONS: Whether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.

Delivery of the research participant perception survey through the patient portal.

INTRODUCTION: The patient portal may be an effective method for administering surveys regarding participant research experiences but has not been systematically studied. METHODS: We evaluated 4 methods of delivering a research participant perception survey: mailing, phone, email, and patient portal. Participants of research studies were identified (n=4013) and 800 were randomly selected to receive a survey, 200 for each method. Outcomes included response rate, survey completeness, and cost. RESULTS: Among those aged <65 years, response rates did not differ between mail, phone, and patient portal (22%, 29%, 30%, p>0.07). Among these methods, the patient portal was the lowest-cost option. Response rates were significantly lower using email (10%, p<0.01), the lowest-cost option. In contrast, among those aged 65+ years, mail was superior to the electronic methods (p<0.02). CONCLUSIONS: The patient portal was among the most effective ways to reach research participants, and was less expensive than surveys administered by mail or telephone.

A survey of intracranial aneurysm treatment practices among United States physicians.

BACKGROUND: Recent surveys have failed to examine cerebrovascular aneurysm treatment practices among US physicians. OBJECTIVE: To survey physicians who are actively involved in the care of patients with cerebrovascular aneurysms to determine current aneurysm treatment preferences. METHODS: A 25-question SurveyMonkey online survey was designed and distributed electronically to members of the Society of NeuroInterventional Surgery, Society of Vascular and Interventional Neurology, and the American Association of Neurological Surgeons/Congress of Neurological Surgeons Combined Cerebrovascular Section. RESULTS: 211 physicians completed the survey. Most respondents recommend endovascular treatment as the first-line management strategy for most ruptured (78%) and unruptured (71%) aneurysms. Thirty-eight per cent of respondents indicate that they routinely treat all patients with subarachnoid hemorrhage regardless of grade. Most physicians use the International Study of Unruptured Intracranial Aneurysms data for counseling patients on natural history risk (80%); a small minority (11%) always or usually recommend treatment of anterior circulation aneurysms of <5 mm. Two-thirds of respondents continue to recommend clipping for most middle cerebral artery aneurysms, while most (51%) recommend flow diversion for wide-necked internal carotid artery aneurysms. Follow-up imaging schedules are highly variable. Neurosurgeons at academic institutions and those practicing longer were more likely to recommend clipping surgery for aneurysms (p<0.05). CONCLUSIONS: This survey demonstrates considerable variability in patient selection for intracranial aneurysm treatment, preferred treatment strategies, and follow-up imaging schedules among US physicians.

Impact of the look AHEAD intervention on NT-pro brain natriuretic peptide in overweight and obese adults with diabetes.

Look AHEAD (Action for Health in Diabetes) is a randomized trial determining whether intensive lifestyle intervention (ILI) aimed at long-term weight loss and increased physical fitness reduces cardiovascular morbidity and mortality in overweight and obese individuals with type 2 diabetes compared to control (diabetes support and education, DSE). We investigated the correlates of N-terminal pro-brain natriuretic peptide (NT-proBNP), a biomarker associated with heart failure (HF) risk, in a subsample from 15 of 16 participating centers and tested the hypothesis that ILI decreased NT-proBNP levels. Baseline and 1-year blood samples were assayed for NT-proBNP in a random sample of 1,500 without, and all 628 with, self-reported baseline CVD (cardiovascular disease) (N = 2,128). Linear models were used to assess relationships that log-transformed NT-proBNP had with CVD risk factors at baseline and that 1-year changes in NT-proBNP had with intervention assignment. At baseline, the mean (s.d.) age, BMI, and hemoglobin A(1c) (HbA(1c)) were 59.6 (6.8) years, 36.0 kg/m(2) (5.8), and 7.2% (1.1), respectively. Baseline geometric mean NT-proBNP was not different by condition (ILI 53.3 vs. DSE 51.5, P = 0.45), was not associated with BMI, and was inversely associated with HbA(1c). At 1 year, ILI participants achieved an average weight loss of 8.3% compared to 0.7% in DSE. At 1 year, NT-proBNP levels increased to a greater extent in the intervention arm (ILI +21.3% vs. DSE +14.2%, P = 0.046). The increased NT-proBNP associated with ILI was correlated with changes in HbA(1c), BMI, and body composition. In conclusion, among overweight and obese persons with diabetes, an ILI that reduced weight was associated with an increased NT-proBNP.

Analysis of outcomes of anterior cruciate ligament repair with 5-year follow-up: allograft versus autograft.

PURPOSE: To prospectively compare outcomes of primary anterior cruciate ligament (ACL) reconstruction with either Achilles tendon allograft with soft-tissue fixation or standard bone-patellar tendon-bone autograft with interference screw fixation. TYPE OF STUDY: Prospective comparative case series. METHODS: A group of 41 patients who underwent soft-tissue allograft reconstruction and a group of 118 patients who underwent autograft bone-patellar tendon-bone reconstruction were included in the final results. Patients were evaluated preoperatively and postoperatively at 1 to 2 weeks, 6 weeks, 3 months, 6 months, and then annually for 5 years. Objective measures of outcome included KT-1000 measurements, range of motion, ligamentous integrity, thigh atrophy, and International Knee Documentation Committee score. Subjective evaluations included patient completion of 5 questionnaires documenting functional status, pain, and health-related quality of life: (1) the short-form McGill Pain Questionnaire, (2) a patient subjective assessment of knee function and symptoms, (3) a patient subjective assessment follow-up, (4) a knee pain scale, and (5) the RAND 36-Item Health Survey. Mixed models analysis of variance was used to compare the outcomes of the treatment groups using baseline values of the study variables as a covariate. RESULTS: Autograft patients reported significantly more pain on the bodily pain subscale of the RAND-36 than the allograft group at 1 week (P = .0006), 6 weeks (P = .0007), and 3 months (P = .0270). Autograft patients reported more pain than allograft patients on the McGill Pain Scale visual analog scale at 1 to 2 weeks (P < .0001) and 6 weeks (P = .0147). Patient assessment of function and symptoms showed that a higher proportion of patients reported normal or nearly normal knee function in the allograft group than in the autograft group at 3 months (33% v 14%, P = .0558, respectively). Fewer activity limitations were reported by allograft patients than autograft patients at 6 weeks (P = .0501), 3 months (P = .0431), and 6 months (P = .0014). After reconstruction, the allograft group displayed significantly more laxity in KT-1000 measurements at all time points than the autograft group (P = .0520). These measurements decreased over time for both groups (P < .0001). CONCLUSIONS: Five-year follow-up of patients undergoing ACL reconstruction with allograft versus autograft were compared objectively and subjectively. Both groups of patients achieved similar long-term outcomes. Overall, the allograft patients reported less pain at 1 and 6 weeks after surgery, better function at 1 week, 3 months, and 1 year, and fewer activity limitations throughout the follow-up period. LEVEL OF EVIDENCE: Level II, prospective cohort study.

Gene expression of nAChR, SNAP-25 and GAP-43 in skeletal muscles following botulinum toxin A injection: a study in rats.

PURPOSE: Botulinum toxin A (BoNT-A) is used to manage spasticity in cerebral palsy. BoNT-A cleaves SNAP-25 protein, blocking acetylcholine release and weakening the muscle. Nicotinic acetylcholine receptors (nAChR) including alpha, beta, delta, gamma, and epsilon subunits, and GAP-43 protein are associated with functional recovery of neuromuscular junctions (NMJ) following BoNT-A. To better understand the mechanism behind this functional recovery, this study attempted to (1) document changes in NMJ morphometry following BoNT-A, and (2) determine the gene expression of nAChR subunits, SNAP-25, and GAP-43 protein. METHODS: In this rat study (46 rats), 6 units/kg body weight of BoNT-A was injected into the gastrocnimus. NMJ morphometry and the time course of gene expression of nAChR subunits, SNAP-25, and GAP-43 were evaluated up to 1year post-injection. RESULTS: NMJ morphometry: gutter depth was reduced vs. the control side at two months, and normalizing by 6 months following BoNT. nAChR alpha mRNA and gamma mRNA increased by 3 days, peaked at 7 days and returned to control levels; delta mRNA peaked at 3 days. Epsilon mRNA peaked by 7 days. SNAP-25 mRNA increased from 60 to 90 days, returning to control levels by 6 months. GAP-43 mRNA was unchanged. CONCLUSIONS: Specific nAChR subunit mRNA expression up-regulates and then returns to normal within two weeks, preceding changes in NMJ morphometry. Although GAP-43 participates in nerve sprouting, no increase of GAP-43 mRNA occurred following BoNT-A. Delayed up-regulation of SNAP-25 mRNA might be associated with muscle functional recovery.

Management of peripheral nerve defects: external fixator-assisted primary neurorrhaphy.

BACKGROUND: Controlled joint extension followed by gradual distraction with use of an external fixator may facilitate primary repair of peripheral nerve defects by permitting end-to-end repair without tension. The hypothesis of the present study was that gradual lengthening of nerve repairs with use of incremental distraction would provide superior results compared with grafting or repair under tension. METHODS: A median nerve segment measuring four times the diameter of the nerve was resected in thirty-six rabbits to create a 7-mm gap in the nerve. Neurorrhaphy was performed with use of one of three techniques. In Group 1 (cable graft), a tension-free medial antebrachial cutaneous graft was placed to allow full range of motion of the elbow postoperatively. In Group 2 (end-to-end repair without distraction), the elbow was externally fixed in hyperflexion and the nerve was repaired end-to-end. At fourteen days, the fixator was removed and unprotected elbow motion was permitted. In Group 3 (end-to-end repair with gradual distraction), the elbow was externally fixed in hyperflexion and primary neurorrhaphy was performed. At fourteen days, the elbow was extended 10 degrees every other day with use of the articulated external fixator until full extension was achieved. Median nerve amplitude, latency, and nerve-conduction velocity; flexor digitorum superficialis single-twitch force generation and maximum tetanic force generation; muscle mass; and elbow range of motion were measured at three or six months. In addition, histologic analysis of the median nerve distal to the repair site and the morphometry of the neuromuscular junction in the flexor digitorum superficialis were performed at six months. RESULTS: All rabbits regained full active and passive range of motion. At three months, the nerve-conduction velocities in Groups 2 and 3 were significantly greater than that in Group 1. At six months, the nerve-conduction velocities and amplitudes in Group 3 were significantly greater than those in Groups 1 and 2. At six months, the tetanic force in Group 3 was significantly greater than those in Groups 1 and 2. There were no significant differences in muscle mass among the groups. There were no significant differences in histological findings among the three groups, although there was a trend toward larger fiber size in Group 3 as compared with the other two groups. The neuromuscular junctions in Group 3 had a significantly larger surface area than did those in Group 1 (p = 0.002) and Group 2 (p = 0.034). CONCLUSION: The use of an articulated external fixator and controlled gradual distraction appears to facilitate the treatment of peripheral nerve defects.

Radius pull test: predictor of longitudinal forearm instability.

BACKGROUND: Longitudinal instability of the forearm (the Essex-Lopresti lesion) following radial head excision may be difficult to detect. This cadaveric study examines a stress test that can be performed in the operating room to identify injury to the ligamentous structures of the forearm. METHODS: Twelve cadaveric upper extremities were randomized into two groups and underwent radial head resection. Group 1 underwent sequential transection of the triangular fibrocartilage complex and the interosseous membrane. Group 2 underwent sequential transection of the interosseous membrane and the triangular fibrocartilage complex. Ulnar variance and radial migration were examined with use of fluoroscopy of the wrist before, during, and after the application of a 9.1-kg load via longitudinal traction on the proximal part of the radius. RESULTS: Group 1 demonstrated no significant changes in proximal radial migration with load (compared with the findings after radial head resection alone) after transection of the triangular fibrocartilage complex. However, Group 2 demonstrated significant changes in proximal radial migration with load after transection of the interosseous membrane (p = 0.03; median, 3.5 mm). In both groups, transection of both the triangular fibrocartilage complex and the interosseous membrane resulted in significant changes in proximal radial migration with load (p = 0.001; median, 9.5 mm). When the load was removed, specimens were ulnar positive (median, 3.0 mm), with no specimen returning to the preload position of ulnar variance (p = 0.001). CONCLUSION: After radial head resection, 3 mm of proximal radial migration with longitudinal traction indicated disruption of the interosseous membrane. In all specimens, proximal radial migration of > or =6 mm with load indicated gross longitudinal instability with disruption of all ligamentous structures of the forearm.