Treatment Option For People Research Articles

Prophylactic removal of impacted mandibular third molars: a systematic review and economic evaluation.

Impacted third molars are third molars that are blocked, by soft tissue or bone, from fully erupting through the gum. This can cause pain and disease. The treatment options for people with impacted third molars are removal or retention with standard care. If there are pathological changes, the current National Institute for Health and Care Excellence guidance states that the impacted third molar should be removed. The objective of this study was to appraise the clinical effectiveness and cost-effectiveness of the prophylactic removal of impacted mandibular third molars compared with retention of, and standard care for, impacted third molars. Five electronic databases were searched (1999 to 29 April 2016) to identify relevant evidence [The Cochrane Library (searched 4 April 2016 and 29 April 2016), MEDLINE (searched 4 April 2016 and 29 April 2016), EMBASE (searched 4 April 2016 and 29 April 2016), EconLit (searched 4 April 2016 and 29 April 2016) and NHS Economic Evaluation Database (searched 4 April 2016)]. Studies that compared the prophylactic removal of impacted mandibular third molars with retention and standard care or studies that assessed the outcomes from either approach were included. The clinical outcomes considered were pathology associated with retention, post-operative complications following extraction and adverse effects of treatment. Cost-effectiveness outcomes included UK costs and health-related quality-of-life measures. In addition, the assessment group constructed a de novo economic model to compare the cost-effectiveness of a prophylactic removal strategy with that of retention and standard care. The clinical review identified four cohort studies and nine systematic reviews. In the two studies that reported on surgical complications, no serious complications were reported. Pathological changes due to retention of asymptomatic impacted mandibular third molars were reported by three studies. In these studies, the extraction rate for retained impacted mandibular third molars varied from 5.5% to 31.4%; this variation can be explained by the differing follow-up periods (i.e. 1 and 5 years). The findings from this review are consistent with the findings from previous systematic reviews. Two published cost-effectiveness studies were identified. The authors of both studies concluded that, to their knowledge, there is currently no economic evidence to support the prophylactic removal of impacted mandibular third molars. The results generated by the assessment group's lifetime economic model indicated that the incremental cost-effectiveness ratio per quality-adjusted life-year gained for the comparison of a prophylactic removal strategy with a retention and standard care strategy is £11,741 for people aged 20 years with asymptomatic impacted mandibular third molars. The incremental cost per person associated with prophylactic extraction is £55.71, with an incremental quality-adjusted life-year gain of 0.005 per person. The base-case incremental cost-effectiveness ratio per quality-adjusted life-year gained was found to be robust when a range of sensitivity and scenario analyses were carried out. Limitations of the study included that no head-to-head trials comparing the effectiveness of prophylactic removal of impacted mandibular third molars with retention and standard care were identified with the assessment group model that was built on observational data. Utility data on impacted mandibular third molars and their symptoms are lacking. The evidence comparing the prophylactic removal of impacted mandibular third molars with retention and standard care is very limited. However, the results from an exploratory assessment group model, which uses available evidence on symptom development and extraction rates of retained impacted mandibular third molars, suggest that prophylactic removal may be the more cost-effective strategy. Effectiveness evidence is lacking. Head-to-head trials comparing the prophylactic removal of trouble-free impacted mandibular third molars with retention and watchful waiting are required. If this is not possible, routine clinical data, using common definitions and outcome reporting methods, should be collected. This study is registered as PROSPERO CRD42016037776. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 30. See the NIHR Journals Library website for further project information.

Knowledge, practice and correlates of sleep hygiene among people living with HIV/AIDS attending anti-retroviral therapy at Zewditu Memorial Hospital, Addis Ababa, Ethiopia: a cross-sectional study

BackgroundSleep hygiene is a series of behavioral practices that can be performed by individuals with sleep complaints to prevent or reverse sleep difficulties. The feasibility, cost-effectiveness, absence of side effects and immediate responses to sleep problems make sleep hygiene practices more applicable than other treatment options for people living with HIV/AIDS. However, there is no evidence regarding sleep hygiene awareness and its practice in people with HIV/AIDS in Ethiopia.ObjectivesThis study aimed to assess the knowledge, practice and correlates of sleep hygiene among adults attending outpatient anti-retroviral treatment at Zewditu Memorial Hospital.MethodsThis was an institutional based cross-sectional study conducted from 1st of May to 16th of June 2018 amongst people attending anti-retroviral therapy follow-up at Zewditu Memorial Hospital. Systematic random sampling technique was used to recruit a total of 396 study participants. Data were collected using interviewer-administered questionnaire. The Sleep Hygiene Index was used to measure the level of sleep hygiene of study participants. Binary logistic regression analysis was conducted to identify factors associated with sleep hygiene practice. In the multi-variable analysis, variables with P-values of less than 0.05 were considered as significant correlates of sleep hygiene practice with 95% confidence interval.ResultsThe findings of this study showed that there are limitations regarding the knowledge and practice of sleep hygiene of people with HIV/AIDS in Ethiopia. None of the participants attended training regarding sleep hygiene. More than half (51.3%) had poor sleep hygiene practice. Female sex [AOR = 5.80:95% CI (3.12, 10.7)], being single [AOR =2.29:95% CI (0.13, 9.51)], depression [AOR = 2.93: 95% CI (1.73, 4.96)] and current khat use [AOR = 3.30; 95% CI (1.67, 6.50)] were identified as statistically significant correlates of poor sleep hygiene practice.ConclusionsKnowledge regarding sleep hygiene is poor, and its practices are incorrect amongst people living with HIV/AIDS in Ethiopia. These findings demonstrate a need for professionals to play a major role in addressing this problem by integrating sleep hygiene as an added treatment modality to the HIV/AIDS care service. Designing training programs and awareness creation strategies for people with HIV/AIDS to improve their sleep hygiene practice is also highly recommended.

Switching Between Glucagon-Like Peptide-1 Receptor Agonists: Rationale and Practical Guidance.

Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of incretin-based therapies for the management of hyperglycemia and, in some cases, cardiovascular risk in people with type 2 diabetes. These agents act on multiple physiological pathways involved in type 2 diabetes with the effect of increasing insulin secretion and decreasing glucagon to control glucose levels (1,2). They also transiently slow gastric emptying, reduce appetite, and facilitate weight loss and other metabolic improvements (3). Consensus recommendations from the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) and American Association of Clinical Endocrinologists/American College of Endocrinology advocate that GLP-1 receptor agonists, among other therapies, should be considered as a second-line treatment option in people with type 2 diabetes when glucose levels are not well controlled on metformin (4–6). Additionally, in patients with type 2 diabetes and atherosclerotic cardiovascular disease or chronic kidney disease, a GLP-1 receptor agonist or sodium–glucose cotransporter 2 (SGLT2) inhibitor with proven cardiovascular benefit is recommended as a first-line therapy for the reduction of cardiovascular risk (4–6). GLP-1 receptor agonists may also be used as a first-line treatment in those who cannot use metformin or when reduced renal function precludes metformin use (human-based GLP-1 receptor agonists only) (4–6). In particular, the recommendations favor GLP-1 receptor agonists and SGLT2 inhibitors because they have a low risk of hypoglycemia and promote weight loss (5). Several GLP-1 receptor agonists are available in the United States and worldwide, some of which are analogs of human GLP-1 (dulaglutide, liraglutide, and semaglutide), whereas others are exendin-based (exenatide and lixisenatide) (7–13). The GLP-1 receptor agonist albiglutide was also approved, but has been withdrawn for commercial reasons. Until recently, all GLP-1 receptor agonists were administered by subcutaneous injection, although a once-daily oral formulation …

Utah legislature approves millions to transform mental health crisis system

Utah legislators this month approved more than $23 million in funding to provide better treatment options for people with mental illness, including the addition of mobile crisis centers and additional treatment beds.

Efficacy and safety of intranasal esketamine for the treatment of major depressive disorder

ABSTRACT Introduction: In March 2019, intranasal esketamine was approved by the Food and Drug Administration (FDA) for the treatment of treatment-resistant depression (TRD) in adults. This review presents the results of clinical trials underlying the FDA approval of intranasal esketamine. Areas covered: Esketamine’s efficacy and safety in TRD were assessed in 5 phase III studies: three 4-week, placebo-controlled studies, and two long-term trials. One short-term trial showed statistically significant antidepressant effects of esketamine vs placebo, while a long-term withdrawal study showed that esketamine is significantly beneficial in terms of extending time to relapse, compared to placebo. Two other short-term trials did not meet the prespecified statistical tests for showing efficacy, although improvement in depressive symptoms from baseline to the end of week 4 favors esketamine over placebo. Expert opinion: Intranasal esketamine is a new treatment option for people with TRD. The main benefit of esketamine is rapid onset of antidepressant activity, but the effects of prolonged treatment are still preliminary. The main concerns relate to the safety aspects of prolonged esketamine therapy, when considering its abuse potential. While data for esketamine use over a long period of time is lacking, its use should be carefully monitored.

Changes in periprosthetic bone mineral density and bone turnover markers after osseointegrated implant surgery: A cohort study of 20 transfemoral amputees with 30-month follow-up.

The osseointegrated implant system is a treatment option for people with transfemoral amputation, but implant removal is not uncommon. The association between bone mineral density changes or bone turnover markers and the need for implant removal has not previously been investigated. The aim was to evaluate changes in bone mineral density and bone turnover markers in people with transfemoral amputations treated with osseointegrated implants. This is a prospective cohort study. Nineteen patients were followed up for 30 months or until implant removal. Bone mineral density was measured in the lumbar spine, proximal femur and seven periprosthetic regions. 25-hydroxyvitamin (D2 + D3), parathyroid hormone, N-terminal propeptide of type-I procollagen, C-telopeptide of type-I collagen, bone-specific alkaline phosphatase and osteocalcin were measured in blood samples. Four fixtures and three abutments were removed. Patients with removed implants had a decreased bone mineral density in the seven periprosthetic regions between 27% (95% confidence interval = 6; 43) and 38% (95% confidence interval = 19; 52) at 30-month follow-up compared to baseline (p < 0.02), whereas bone mineral density around non-removed implants normalized to baseline values (p > 0.08). C-telopeptide of type-I collagen was significantly different between the groups at 18- and 24-month follow-up (p < 0.05). None of the measured variables were significant predictors of implant removal (p > 0.07). Implant removal was associated with loss of periprosthetic bone mineral density and increase in C-telopeptide of type-I collagen in the years following osseointegrated surgery. This study offers new insight into changes in bone mineral density and bone turnover markers that precipitate aseptic or septic osseointegrated implant removal. Results of this study could contribute to clinical guidelines for monitoring rehabilitation progress and implant removal through dual-energy X-ray absorptiometry or surrogate markers like C-telopeptide of type-I collagen.

HCV point-of-care screening programme and treatment options for people who use drugs in a metropolitan area of Southern Italy.

People who use drugs (PWUD) represent an active reservoir of HCV infection. The prevalence of chronic HCV infection in PWUD in Italy remains unknown because of the lack of systematic screening. Thanks to direct-acting antiviral agents (DAAs), hepatitis C can now be cured in most patients. Thus, the next challenge is to provide linkage-to-care for these patients. In this scenario, we conducted a screening programme in PWUD attending seven Addiction Centers in Southern Italy, as well as a treatment programme in the Liver Unit of the University Hospital of Salerno. We used the OraQuick HCV antibody test to screen the PWUD (from 1 April to 30 September 2018). 593 subjects were consecutively enrolled in the programme; 250 (41.8%) were HCV-Ab-positive. 143 (24.1%) were aware of their infection and had been HCV-RNA-tested: 83 were positive and 60 negative. The remaining 107 subjects (18.1%) had never previously been tested and were unaware of their infection. A total of 160 (26.9%) HCV RNA-positive patients were found and offered antiviral therapy with DAAs. The sustained virological response rate was 98.5% and no adverse events were recorded. Two patients voluntarily discontinued treatment. No reinfections have been recorded to date. The prevalence of HCV-Ab positivity was high in the PWUDs enrolled in this study, and almost half the patients were unaware of being HCV-positive. The linkage-to-care provided was safe and effective, and no case of reinfection was recorded.

Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment Resistant Depression: Retrospective Data Analysis from Clinical Practice

Objective: The aim of this paper is to present the service data results from a clinical repetitive Transcranial Magnetic Stimulation (rTMS) service treating treatment resistant depression (TRD). Methods: The study was a retrospective investigation of routinely collected data on patients receiving rTMS between 2015 and 2018. Measures used were the clinician-rated Clinical Global Impression (CGI) and Hamilton Depression Rating Scale (HAM-D), and patient rated Physical Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder 7 (GAD-7). The outcome data of 144 patients with TRD was analysed. The sample included patients with co-morbid psychiatric diagnosis. Results: Response and remission rates respectively were 34.6% and 20.6% for the HAM-D; 10% and 28.6% for the PHQ-9; 31% and 31.8% for the CGI; and 24.6% and 28.8% for GAD-7. Effect sizes were mostly medium (0.48, 0.27, 0.51, 0.43 respectively). GAD-7 reliable change improvement was 56.1% and PHQ-9 reliable change improvement was 40%. There was a medium positive correlation between anxiety (GAD-7) and depression recovery (HAM-D), r = 0.31, n = 46, p = 0.039, with lower pre-treatment anxiety associated with lower post-treatment HAM-D scores. Conclusions: TRD patients with low pre-treatment anxiety levels respond to treatment better than those with high pre-treatment anxiety. The results show that a clinical rTMS service can have a significant impact on symptoms of depression and anxiety in TRD. The findings support wider availability of rTMS as a treatment option for people with TRD.

Bridging the divide: the adjustment and decision-making experiences of people with dementia living with a recent diagnosis of cancer and its impact on family carers

AbstractThe risk of living with dementia and, separately, cancer, increases exponentially with age. However, to date, there is a paucity of research investigating the experiences of people living with both these conditions. This study used semi-structured interviews to explore the decision-making and treatment options for people who live with both dementia and cancer. In total, ten people living with both dementia and cancer (aged 39–93 years) and nine family carers were interviewed. Braun and Clarke's approach to thematic analysis was used together with framework matrices to organise the data. In this article four sequential and descriptive themes are presented. ‘Reaching a diagnosis of cancer’ describes the vital role that family carers play in encouraging the person with dementia to seek an explanation for their presenting (undiagnosed cancer) symptoms to their general practitioner. ‘Adjusting to the cancer diagnosis when living with dementia’ outlines a variety of emotional and practical responses to receiving news of the diagnosis. ‘Weighing up the cancer treatment options’ highlights the different decisions and circumstances that family carers and people living with both dementia and cancer are faced with post-diagnosis. ‘Undergoing cancer treatment’ shares the finding that cancer treatment decision-making was not straightforward and that people living with both dementia and cancer would often forget about their cancer and what procedures they had been through.

Obesity and cardiovascular risk: a call for action from the European Society of Hypertension Working Group of Obesity, Diabetes and the High-risk Patient and European Association for the Study of Obesity: part A: mechanisms of obesity induced hypertension, diabetes and dyslipidemia and practice guidelines for treatment.

: Obesity is a key factor for cardiovascular diseases and complications. Obesity is associated with hypertension, dyslipidemia and type II diabetes, which are the major predictors of cardiovascular disease in the future. It predisposes for atrial fibrillation, heart failure, sudden cardiac death, renal disease and ischemic stroke that are the main causes of cardiovascular hospitalization and mortality. As obesity and the cardiovascular effects on the vessels and the heart start early in life, even from childhood, it is important for health policies to prevent obesity very early before the disease manifestation emerge. Key roles in the prevention are strategies to increase physical exercise, reduce body weight and to prevent or treat hypertension, lipids disorders and diabetes earlier and efficiently to prevent cardiovascular complications.Epidemiology and mechanisms of obesity-induced hypertension, diabetes and dyslipidemia will be reviewed and the role of lifestyle modification and treatment strategies in obesity will be updated and analyzed. The best treatment options for people with obesity, hypertension, diabetes and dyslipidemia will discussed.

Physical activity for people with young-onset dementia and carers: protocol for a scoping review

BackgroundPhysical activity has been cited as a potential symptomatic treatment option for people living with dementia. At present, much of the research concerning physical activity and dementia considers older adults, and there are several review articles summarising the evidence in this area. Less is known about physical activity for younger people with dementia, despite the marked differences in needs and preferences between the two groups. The aim of this scoping review is to systematically explore and critically appraise the current state of the evidence regarding physical activity for people with young-onset dementia and carers.MethodsSeveral electronic databases (i.e. MEDLINE, SPORTDiscus, CINAHL, Cochrane Library, PsycINFO, Applied Social Sciences Index & s (ASSIA) and Scopus), grey literature (i.e. NICE Evidence Search (UK) and targeted international organisations e.g. Alzheimer’s Society (UK), Age UK, Young Dementia UK, Alzheimer’s Association (USA), Dementia Australia) and trial registries (i.e. UK Clinical Trials Gateway, International Clinical Trials Registry Platform and EU Clinical Trials Register) will be searched for published and unpublished evidence regarding physical activity for people with young-onset dementia and carers. Studies included in the review will be subjected to a narrative synthesis to explore similarities and differences, both within and between studies, to identify patterns and themes and to postulate explanations for research findings (e.g. how and why certain interventions or programmes have worked (or not); factors that might have influenced the findings ).DiscussionThis will be the first review to systematically explore and critically appraise the current state of the evidence regarding physical activity for people with young-onset dementia and carers. It is hoped that findings from this review will be used to inform the development of future physical activity interventions, to serve as a basis for consultation with key stakeholders and to identify appropriate outcome measures relevant to people with young-onset dementia and carers.Systematic review registrationAt present, scoping reviews are not eligible for registration on the international prospective register of systematic reviews (i.e. PROSPERO).

Taking Control Of Your Diabetes: An Innovative Approach to Improving Diabetes Care Through Educating, Motivating, and Making the Connection Between Patients and Health Care Providers.

The gold-standard goal of diabetes management has been to achieve meaningful and sustained glycemic control to reduce the risk of long-term complications. Unfortunately, results from the National Health and Nutrition Examination Survey indicate that only ∼50% of adults with diabetes in the United States, mostly with type 2 diabetes, are achieving an A1C <7.0%, and this percentage has not changed over the past decade (1). In addition, the proportion of patients meeting individualized targets has declined according to the American Diabetes Association and American Association of Clinical Endocrinologists, and the overall proportion of patients in very poor control, defined as an A1C >9%, has actually increased (2,3). The Healthcare Effectiveness Data and Information Set results, with data from >1,000 health plans covering >171 million lives, are even more striking, demonstrating that, in 2014, ∼40% of commercially insured health maintenance organization patients and 30% of government insured patients achieved an A1C <7.0, again reflecting no change in the past 10 years (4). All of this has occurred despite the introduction of >40 new treatment options for people with type 2 diabetes. This fact is quite shocking and difficult to understand, especially given that our armamentarium of effective and safe type 2 medications has expanded over the same time period to include dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium glucose cotransporter 2 inhibitors, designer insulins, inhaled insulin, and glucagon-like peptide 1 (GLP-1) receptor agonists. Although there may be many reasons why these new treatment options haven’t made a dent in the glycemic control of our patients with type 2 diabetes during these past 10 years, I feel strongly that the basic and primary issue is a lack of patient education, motivation, and activation. Type 2 diabetes is a silent condition with few or no symptoms caused by poor …

Effects of Exercise on Depression and Anxiety. A Comparison to Transdiagnostic Cognitive Behavioral Therapy.

The aims of this study were (i) to know the effects of an exercise program on a group of people with depression and anxiety and (ii) to compare theses effects with a transdiagnostic cognitive behavioral group therapy (TCBGT). The participants were 15 people with depression and/or anxiety symptoms. The participants followed an exercise program. Depression and anxiety symptoms were assessed with validated questionnaires. An exercise program can be used as a treatment option for people with depression and/or anxiety with good results in comparison with TCBGT.

When is dual bronchodilation indicated in COPD?

Inhaled bronchodilator medications are central to the management of COPD and are frequently given on a regular basis to prevent or reduce symptoms. While short-acting bronchodilators are a treatment option for people with relatively few COPD symptoms and at low risk of exacerbations, for the majority of patients with significant breathlessness at the time of diagnosis, long-acting bronchodilators may be required. Dual bronchodilation with a long-acting β2-agonist and long-acting muscarinic antagonist may be more effective treatment for some of these patients, with the aim of improving symptoms. This combination may also reduce the rate of exacerbations compared with a bronchodilator-inhaled corticosteroid combination in those with a history of exacerbations. However, there is currently a lack of guidance on clinical indicators suggesting which patients should step up from mono- to dual bronchodilation. In this article, we discuss a number of clinical indicators that could prompt a patient and physician to consider treatment escalation, while being mindful of the need to avoid unnecessary polypharmacy. These indicators include insufficient symptomatic response, a sustained increased requirement for rescue medication, suboptimal 24-hour symptom control, deteriorating symptoms, the occurrence of exacerbations, COPD-related hospitalization, and reductions in lung function. Future research is required to provide a better understanding of the optimal timing and benefits of treatment escalation and to identify the appropriate tools to inform this decision.

Cabazitaxel for Hormone-Relapsed Metastatic Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana®, Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the company's submission to NICE. Clinical evidence for cabazitaxel was derived from a multinational randomised open-label phase III trial (TROPIC) of cabazitaxel plus prednisone or prednisolone compared with mitoxantrone plus prednisone or prednisolone, which was assumed to represent best supportive care. The NICE final scope identified a further three comparators: abiraterone in combination with prednisone or prednisolone; enzalutamide; and radium-223 dichloride for the subgroup of people with bone metastasis only (no visceral metastasis). The company did not consider radium-223 dichloride to be a relevant comparator. Neither abiraterone nor enzalutamide has been directly compared in a trial with cabazitaxel. Instead, clinical evidence was synthesised within a network meta-analysis (NMA). Results from TROPIC showed that cabazitaxel was associated with a statistically significant improvement in both overall survival and progression-free survival compared with mitoxantrone. Results from a random-effects NMA, as conducted by the company and updated by the ERG, indicated that there was no statistically significant difference between the three active treatments for both overall survival and progression-free survival. Utility data were not collected as part of the TROPIC trial, and were instead taken from the company's UK early access programme. Evidence on resource use came from the TROPIC trial, supplemented by both expert clinical opinion and a UK clinical audit. List prices were used for mitoxantrone, abiraterone and enzalutamide as directed by NICE, although commercial in-confidence patient-access schemes (PASs) are in place for abiraterone and enzalutamide. The confidential PAS was used for cabazitaxel. Sequential use of the advanced hormonal therapies (abiraterone and enzalutamide) does not usually occur in clinical practice in the UK. Hence, cabazitaxel could be used within two pathways of care: either when an advanced hormonal therapy was used pre-docetaxel, or when one was used post-docetaxel. The company believed that the former pathway was more likely to represent standard National Health Service (NHS) practice, and so their main comparison was between cabazitaxel and mitoxantrone, with effectiveness data from the TROPIC trial. Results of the company's updated cost-effectiveness analysis estimated a probabilistic incremental cost-effectiveness ratio (ICER) of £45,982 per quality-adjusted life-year (QALY) gained, which the committee considered to be the most plausible value for this comparison. Cabazitaxel was estimated to be both cheaper and more effective than abiraterone. Cabazitaxel was estimated to be cheaper but less effective than enzalutamide, resulting in an ICER of £212,038 per QALY gained for enzalutamide compared with cabazitaxel. The ERG noted that radium-223 is a valid comparator (for the indicated sub-group), and that it may be used in either of the two care pathways. Hence, its exclusion leads to uncertainty in the cost-effectiveness results. In addition, the company assumed that there would be no drug wastage when cabazitaxel was used, with cost-effectiveness results being sensitive to this assumption: modelling drug wastage increased the ICER comparing cabazitaxel with mitoxantrone to over £55,000 per QALY gained. The ERG updated the company's NMA and used a random effects model to perform a fully incremental analysis between cabazitaxel, abiraterone, enzalutamide and best supportive care using PASs for abiraterone and enzalutamide. Results showed that both cabazitaxel and abiraterone were extendedly dominated by the combination of best supportive care and enzalutamide. Preliminary guidance from the committee, which included wastage of cabazitaxel, did not recommend its use. In response, the company provided both a further discount to the confidential PAS for cabazitaxel and confirmation from NHS England that it is appropriate to supply and purchase cabazitaxel in pre-prepared intravenous-infusion bags, which would remove the cost of drug wastage. As a result, the committee recommended use of cabazitaxel as a treatment option in people with an Eastern Cooperative Oncology Group performance status of 0 or 1 whose disease had progressed during or after treatment with at least 225mg/m2 of docetaxel, as long as it was provided at the discount agreed in the PAS and purchased in either pre-prepared intravenous-infusion bags or in vials at a reduced price to reflect the average per-patient drug wastage.

Assessing the Effects of Repetitive Transcranial Magnetic Stimulation on Cognition in Major Depressive Disorder Using Computerized Cognitive Testing.

A range of different treatment approaches are available for depression; however, there is an ongoing concern about the cognitive impairment associated with many treatments. This study investigated the effect of treatment with repetitive transcranial magnetic stimulation (rTMS) on cognition in patients with major depressive disorder. Cognition before and after treatment was assessed using a computerized cognitive testing battery, which provided comprehensive assessment across a range of cognitive domains. This was a naturalistic study involving patients attending an outpatient clinical rTMS service. A total of 63 patients with treatment-resistant depression completed the IntegNeuro cognitive test battery, a well-validated comprehensive computerized assessment tool before and after receiving 18 or 20 treatments of sequential bilateral rTMS. Change in the various cognitive domains was assessed, and analyses were undertaken to determine whether any change in cognition was associated with a change in rating of depression severity. There was a significant decrease in Hamilton Depression Rating Scale scores from baseline to posttreatment. There was no decline in performance on any of the cognitive tests. There were significant improvements in maze completion time and the number of errors in the maze task. However, these were accounted for by improvement in mood when change in depressive symptoms was included as a covariate. This open-label study provides further support for the efficacy and safety of rTMS as a treatment option for people with major depressive disorder in a naturalistic clinical setting. Using a comprehensive, robust computerized battery of cognitive tests, the current study indicated that there was no significant cognitive impairment associated with rTMS and that any improvements in cognitive functioning were associated with a reduction in depressive symptoms.

Pilates exercise training vs. physical therapy for improving walking and balance in people with multiple sclerosis: a randomized controlled trial

Objective: Evaluate the effects of a Pilates exercise programme on walking and balance in people with multiple sclerosis and compare this exercise approach to conventional physical therapy sessions. Design: Randomized controlled trial. Setting: Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Subjects: Forty-five people with multiple sclerosis, 29 females, mean age (SD) was 43.2 (11.6) years; mean Expanded Disability Status Scale (S.D) was 4.3 (1.3). Interventions: Participants received 12 weekly training sessions of either Pilates (n=22) or standardized physical therapy (n=23) in an outpatient basis. Main measures: Spatio-temporal parameters of walking and posturography parameters during static stance. Functional tests included the Time Up and Go Test, 2 and 6-minute walk test, Functional Reach Test, Berg Balance Scale and the Four Square Step Test. In addition, the following self-report forms included the Multiple Sclerosis Walking Scale and Modified Fatigue Impact Scale. Results: At the termination, both groups had significantly increased their walking speed (P=0.021) and mean step length (P=0.023). According to the 2-minute and 6-minute walking tests, both groups at the end of the intervention program had increased their walking speed. Mean (SD) increase in the Pilates and physical therapy groups were 39.1 (78.3) and 25.3 (67.2) meters, respectively. There was no effect of group X time in all instrumented and clinical balance and gait measures. Conclusions: Pilates is a possible treatment option for people with multiple sclerosis in order to improve their walking and balance capabilities. However, this approach does not have any significant advantage over standardized physical therapy.

Medical versus surgical treatment for refractory or recurrent peptic ulcer

Background Refractory peptic ulcers are ulcers in the stomach or duodenum that do not heal after eight to 12 weeks of medical treatment or those that are associated with complications despite medical treatment. Recurrent peptic ulcers are peptic ulcers that recur after healing of the ulcer. Given the number of deaths due to peptic ulcer-related complications and the long-term complications of medical treatment (increased incidence of fracture), it is unclear whether medical or surgical intervention is the better treatment option in people with recurrent or refractory peptic ulcers. Objectives To assess the benefits and harms of medical versus surgical treatment for people with recurrent or refractory peptic ulcer. Search methods We searched the specialised register of the Cochrane Upper GI and Pancreatic Diseases group, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and trials registers until September 2015 to identify randomised trials and non-randomised studies, using search strategies. We also searched the references of included studies to identify further studies. Selection criteria We considered randomised controlled trials and non-randomised studies comparing medical treatment with surgical treatment in people with refractory or recurrent peptic ulcer, irrespective of language, blinding, or publication status for inclusion in the review. Data collection and analysis Two review authors independently identified trials and extracted data. We planned to calculate the risk ratio, mean difference, standardised mean difference, or hazard ratio with 95% confidence intervals using both fixed-effect and random-effects models with Review Manager 5 based on intention-to-treat analysis. Main results We included only one non-randomised study published 30 years ago in the review. This study included 77 participants who had gastric ulcer and in whom medical therapy (histamine H2 receptor blockers, antacids, and diet) had failed after an average duration of treatment of 29 months. The authors do not state whether these were recurrent or refractory ulcers. It appears that the participants did not have previous complications such as bleeding or perforation. Of the 77 included participants, 37 participants continued to have medical therapy while 40 participants received surgical therapy (antrectomy with or without vagotomy; subtotal gastrectomy with or without vagotomy; vagotomy; pyloroplasty and suture of the ulcer; suture or closure of ulcer without vagotomy or excision of the ulcer; proximal gastric or parietal cell vagotomy alone; suture or closure of the ulcer with proximal gastric or parietal cell vagotomy). Whether to use medical or surgical treatment was determined by participant's or treating physician's preference. The study authors reported that two participants in the medical treatment group (2 out of 37; 5.4%) had gastric cancer, which was identified by repeated biopsy. They did not report the proportion of participants who had gastric cancer in the surgical treatment group. They also did not report the implications of the delayed diagnosis of gastric cancer in the medical treatment group. They did not report any other outcomes of interest for this review (that is health-related quality of life (using any validated scale), adverse events and serious adverse events, peptic ulcer bleeding, peptic ulcer perforation, abdominal pain, and long-term mortality). Authors' conclusions We found no studies that provide the relative benefits and harms of medical versus surgical treatment for recurrent or refractory peptic ulcers. Studies that evaluate the natural history of recurrent and refractory peptic ulcers are urgently required to determine whether randomised controlled trials comparing medical versus surgical management in patients with recurrent or refractory peptic ulcers or both are necessary. Such studies will also provide information for the design of such randomised controlled trials. A minimum follow-up of two to three years will allow the calculation of the incidence of complications and gastric cancer (in gastric ulcers only) in recurrent and refractory peptic ulcers. In addition to complications related to treatment and disease, health-related quality of life and loss of productivity should also be measured.

Behavioral Weight Loss Treatments for Individuals with Migraine and Obesity.

Migraine and obesity are each prevalent disorders involving significant personal and societal burden. Epidemiologic research demonstrates a link between migraine and obesity that is further substantiated by putative behavioral, psychosocial, and physiological mechanisms. As obesity is considered a modifiable risk factor for exacerbation of migraine, weight loss may be a particularly useful treatment option for people with comorbid migraine and obesity. Behavioral weight loss interventions complement existing behavioral treatments for migraine and offer patients evidence-based effective strategies for achieving weight loss that could help reduce frequency, severity, and impact of migraine attacks.

The state of the art in non-pharmacological interventions for developmental stuttering. Part 1: a systematic review of effectiveness.

BackgroundThe growing range of available treatment options for people who stutter presents a challenge for clinicians, service managers and commissioners, who need to have access to the best available treatment evidence to guide them in providing the most appropriate interventions. While a number of reviews of interventions for specific populations or a specific type of intervention have been carried out, a broad‐based systematic review across all forms of intervention for adults and children was needed to provide evidence to underpin future guidelines, inform the implementation of effective treatments and identify future research priorities.AimsTo identify and synthesize the published research evidence on the clinical effectiveness of the broad range of non‐pharmacological interventions for the management of developmental stuttering.Methods & ProceduresA systematic review of the literature reporting interventions for developmental stuttering was carried out between August 2013 and April 2014. Searches were not limited by language or location, but were restricted by date to studies published from 1990 onwards. Methods for the identification of relevant studies included electronic database searching, reference list checking, citation searching and hand searching of key journals. Appraisal of study quality was performed using a tool based on established criteria for considering risk of bias. Due to heterogeneity in intervention content and outcomes, a narrative synthesis was completed.Main ContributionThe review included all available types of intervention and found that most may be of benefit to at least some people who stutter. There was evidence, however, of considerable individual variation in response to these interventions. The review indicated that effects could be maintained following all types of interventions (although this was weakest with regard to feedback and technology interventions).ConclusionsThis review highlights a need for greater consensus with regard to the key outcomes used to evaluate stuttering interventions, and also a need for enhanced understanding of the process whereby interventions effect change. Further analysis of the variation in effectiveness for different individuals or groups is needed in order to identify who may benefit most from which intervention.