The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread ...implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care.
We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m2 or more (or ≥28 kg/m2 with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+—a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face POWeR+F; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote POWeR+R; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703.
Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg SD 21·11; n=279, 6 months 101·91 kg 19·35; n=136, 12 months 101·74 kg 19·57; n=227). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6–2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34–2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96–2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31–2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI −129 to 195) for POWeR+F and –£25 (−268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported.
Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year.
Health Technology Assessment Programme of the National Institute for Health Research.
This is a comprehensive overview of current research and music therapy practice for young children with autism spectrum disorders (ASD) and their families.
Erectile dysfunction is a common complication of spinal cord injury. This double‐blind, placebo‐controlled, two‐way crossover study assessed the efficacy and safety of oral sildenafil in men with ...erectile dysfunction caused by traumatic spinal cord injury. A total of 178 men (mean age, 38 years) received placebo or sildenafil 1 hour before sexual activity for 6 weeks; after a 2‐week washout period, the men received the alternate treatment for 6 weeks. The 50‐mg starting dose could be adjusted to 100 or 25 mg based on efficacy and tolerability. Efficacy was assessed by using global efficacy questions, the International Index of Erectile Function (IIEF), and a patient log of erectile activity. Of 143 men with residual erectile function at baseline, 111 (78%) reported improved erections and preferred sildenafil to placebo. For all men (including those who reported no residual erectile function at baseline), 127 of 168 (76%) reported improved erections and preferred sildenafil to placebo. For all men, 132 of 166 (80%) reported that sildenafil improved sexual intercourse compared with 17 of 166 men (10%) reporting improvement with placebo. IIEF questions assessing the ability to achieve and maintain erections and satisfaction with sexual intercourse demonstrated significant improvement with sildenafil. Sildenafil was well tolerated, with a low rate of discontinuation because of treatment‐related adverse events (2% vs 1% for placebo). Oral sildenafil is an effective and well‐tolerated treatment for erectile dysfunction caused by spinal cord injury. Ann Neurol 1999;46:15–21
Background Mutations in Janus kinase 3 (JAK3) are a cause of severe combined immunodeficiency, but hypomorphic JAK3 defects can result in a milder clinical phenotype, with residual development and ...function of autologous T cells. Maternal T-cell engraftment is a common finding in infants with severe combined immunodeficiency but is not typically observed in patients with residual T-cell development. Objective We sought to study in detail the molecular, cellular, and humoral immune phenotype and function of 3 patients with hypomorphic JAK3 mutations. Methods We analyzed the distribution and function of T and B lymphocytes in 3 patients and studied the in vitro and in vivo responses of maternal T lymphocytes in 1 patient with maternal T-cell engraftment and residual production of autologous T lymphocytes. Results B cells were present in normal numbers but with abnormal distribution of marginal zone–like and memory B cells. B-cell differentiation to plasmablasts in vitro in response to CD40 ligand and IL-21 was abolished. In 2 patients the T-cell repertoire was moderately restricted. Surprisingly, 1 patient showed coexistence of maternal and autologous T lymphocytes. By using an mAb recognizing the maternal noninherited HLA-A2 antigen, we found that autologous cells progressively accumulated in vivo but did not compete with maternal cells in vitro. Conclusion The study of 3 patients with hypomorphic JAK3 mutations suggests that terminal B-cell maturation/differentiation requires intact JAK3 function, even if partially functioning T lymphocytes are present. Maternal T-cell engraftment can occur in patients with JAK3 mutations despite the presence of autologous T cells.
Lateral scapular radiographs have been routinely included in the initial radiographic examination of both traumatic and nontraumatic shoulder conditions. With the advance of modern imaging ...modalities, the clinical utility of the lateral scapular view has become questionable. The purpose of the study was to assess the utilization of the lateral scapular view among the members of the American Shoulder and Elbow Surgeons (ASES) and to determine the clinical utility of the lateral scapular view in the initial evaluation of nontraumatic shoulder conditions.
The study consisted of two parts. The first part involved an online survey of ASES members, which asked them 3 questions regarding their preference for radiographic evaluation of new patients with nontraumatic shoulder pain. The second part involved a clinical vignette–based survey, where 4 shoulder surgeons at our institution were given 50 clinical vignettes and asked to independently answer 4 questions regarding the most probable diagnosis, abnormal radiographic findings, further imaging studies, and treatment plan for each case. The survey was repeated twice; the first was given without a lateral scapular view, and the second given 4 weeks later with a lateral scapular view included. We obtained diagnostic accuracy and percent agreement of each surgeon over two surveys and intraobserver and interobserver reliability on each variable.
Of a total of 235 ASES members who responded to the online survey, 193 (82.1%) indicated their routine use of a lateral scapular view. The most common reason for obtaining the view was better characterization of acromion morphology (75.4%). The clinical vignette–based survey showed substantial intrarater reliability (κ > 0.6) of the 4 surgeons between the two surveys for the most probable diagnosis, abnormal x-ray findings, and further imaging studies, while the intrarater reliability for treatment plan was moderate (κ = 0.548). The mean diagnostic accuracy of the 4 surgeons was almost equal (74% vs. 75%) between the surveys. Overall, each surgeon’s percent agreement across the 2 surveys was over 70%. None of the 4 surgeons recommended a lateral scapular view for further imaging during the first survey; each wanted either advanced imaging (computed tomography, magnetic resonance imaging) or none.
The addition of a lateral scapular radiograph in the presence of other orthogonal views does not appear to improve surgeons' diagnostic accuracy or affect their decision-making on the treatment plan in nontraumatic shoulder conditions. The clinical utility of the lateral scapular view may need to be reassessed in this setting.
Background
Intraarticular corticosteroid injection is commonly used conservative treatment for glenohumeral osteoarthritis (OA). The purpose of this study was to investigate the clinical fate of ...symptomatic glenohumeral OA following intraarticular corticosteroid injection and to identify factors associated with undergoing shoulder arthroplasty.
Methods
Glenohumeral OA patients who had undergone at least one glenohumeral corticosteroid injection from 2012 to 2017 were identified. Data for demographics, comorbidities, number of injections, severity of radiographic arthritis, and subsequent treatment were collected up to February 2020. Data were analyzed to compare between patients who had eventually undergone shoulder arthroplasty and those who had not.
Results
A total of 311 shoulders (275 patients) were followed up for 3 to 8 years after the index injection. The mean age of patients was 64.7 years. There were 148 females, and 116 shoulders (37.3%) eventually underwent arthroplasty, 68 (21.9%) further injections only, 104 (33.4%) no further treatment, 14 (4.5%) a non-arthroplasty surgical procedure, and 9 (2.9%) were lost to follow up. Severity of radiographic arthritic changes, female sex, younger age, and nonsmoking status were found to be significantly associated with undergoing arthroplasty (p < 0.001, p = 0.014, p = 0.003, and p = 0.043, respectively).
Conclusion
Approximately one third of glenohumeral OA patients who had received an intraarticular corticosteroid injection eventually elected to undergo shoulder arthroplasty within 3 to 8 years of the injection. High-grade arthritic changes in radiographs, female gender, and younger age were found to be independent factors associated with undergoing arthroplasty. This information may be useful in counseling patients about their future clinical course.
Level of Evidence: Level III Retrospective comparative study
The role of cardiovascular risk reduction in patients with diabetes mellitus is significant as several factors have been found to promote accelerated atherosclerosis in persons with diabetes ...including hyperglycemia-induced endothelial dysfunction, impaired fibrinolysis, increased platelet aggregation, plaque instability, dysfunctional arterial remodeling, and fibrotic and calcified coronary arteries. Recent attention has focused on identifying a cardiovascular biomarker that would propose a better noninvasive way to detect or visualize subclinical cardiovascular disease and prevent cardiovascular events. This article reviews the use of commonly used cardiovascular risk assessment tools and emerging biomarkers including coronary artery calcium scanning, metabolomics, genomics, and the role of optimal revascularization and risk reduction strategies and their impact on reducing risk in patients with cardiovascular disease and diabetes.
Mechanical circulatory support is increasingly used to bridge children with end-stage heart failure to transplant. Quality of life (QoL) has not been systematically evaluated in children bridged to ...heart transplant.
All children transplanted for cardiomyopathy during 2001 to 2008 and currently being followed at our center (n = 84) had QoL assessed during 2006 to 2009, at a median of 3 years post-transplant, using a validated generic measure (PedsQL4.0).
Twenty-six children, aged 2.7 to 18 (median 7.4) years who were bridged to transplant, were compared with 58 children, aged 2.0 to 18.0 (median 13.0) years, who were transplanted in the same era without bridging. There were no significant differences between the 2 groups on any domains of QoL assessed by children or parents, although the small number of bridged patients increases the likelihood of a Type II error. Bridged children who were younger (r = 0.48, p = 0.02) or more recently transplanted (r = 0.42, p = 0.04) were scored by their parents as having poorer emotional QoL. Regression analysis indicated that age at transplant was the only medical or demographic variable associated with parent-reported total QoL scores (β = 0.27, p = 0.01). With few links between QoL scores and medical or demographic factors, other subjective psychologic factors may be of greater salience in determining QoL.
Despite greater severity of illness, children who required mechanical bridging to transplantation report a QoL comparable to that of other children undergoing heart transplantation. Younger children may require greater psychologic support to reach their full potential in terms of QoL.