Could the Transition movement help solve the NHS's problems?

Background: The NHS Five Year Forward View identifies a range of approaches for addressing the NHS's challenges. The Transition movement helps communities to reframe and rebuild their world by working on issues such as climate change, food, community relationships and localizing the economy. Methods: This paper describes Transition using five short example projects and, informed by these, identifies mechanisms by which Transition could potentially help reduce pressure on the NHS. Results: Transition is characterized by people self-organizing to address local challenges with benefits arising from both the outcomes and the process of the projects. Transition may be able to help the NHS reframe change, prevent disease, improve staff well-being and increase local economic resilience. Discussion: The evidence base for the relationship between Transition and health is growing but is not yet well developed. This reflects the complexity of establishing an evidence base for wider determinants of health. There is substantial potential learning for those in the NHS about change outside formal institutional structures. Conclusions: Transition provides new ways of thinking and acting to develop greater 'community intelligence', which could help the NHS in the face of increasing pressures.

Epicondylitis: lateral.

Lateral epicondylitis is the most common cause of lateral elbow pain in adults. Although it is typically a self-limiting process, there are many nonsurgical and surgical treatment options available if lateral epicondylitis becomes chronic and continues to cause pain. Its common name, tennis elbow, is somewhat of a misnomer because the condition is often work-related and occurs in athletes and nonathletes alike. Acute onset of symptoms occurs more often in young athletes; chronic, recalcitrant symptoms typically occur in older patients. In this review, we describe the pathogenesis and clinical presentation and the nonsurgical and surgical treatment options currently available.

Surrogate outcomes: experiences at the Common Drug Review.

BACKGROUND: Surrogate outcomes are a significant challenge in drug evaluation for health technology assessment (HTA) agencies. The research objectives were to: identify factors associated with surrogate use and acceptability in Canada's Common Drug Review (CDR) recommendations, and compare the CDR with other HTA or regulatory agencies regarding surrogate concerns. METHODS: Final recommendations were identified from CDR inception (September 2003) to December 31, 2010. Recommendations were classified by type of outcome (surrogate, final, other) and acceptability of surrogates (determined by the presence/absence of statements of concern regarding surrogates). Descriptive and statistical analyses examined factors related to surrogate use and acceptability. For thirteen surrogate-based submissions, recommendations from international HTA and regulatory agencies were reviewed for statements about surrogate acceptability. RESULTS: Of 156 final recommendations, 68 (44%) involved surrogates. The overall 'do not list' (DNL) rate was 48%; the DNL rate for surrogates was 41% (p = 0.175). The DNL rate was 64% for non-accepted surrogates (n = 28) versus 25% for accepted surrogates (odds ratio 5.4, p = 0.002). Clinical uncertainty, use of economic evidence over price alone, and a premium price were significantly associated with non-accepted surrogates. Surrogates were used most commonly for HIV, diabetes, rare diseases, cardiovascular disease and cancer. For the subset of drugs studied, other HTA agencies did not express concerns for most recommendations, while regulatory agencies frequently stated surrogate acceptance. CONCLUSIONS: The majority of surrogates were accepted at the CDR. Non-accepted surrogates were significantly associated with clinical uncertainty and a DNL recommendation. There was inconsistency of surrogate acceptability across several international agencies. Stakeholders should consider collaboratively establishing guidelines on the use, validation, and acceptability of surrogates.

Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis.

BACKGROUND: Pulmonary vein isolation (PVI) forms the basis of catheter ablation strategies for atrial fibrillation (AF). Ablation of additional sites has been used to increase the efficacy of ablation procedures in restoring and maintaining normal sinus rhythm. OBJECTIVE: The aim of this paper was to compare the effectiveness of PVI versus PVI plus adjuvant atrial ablations (PVI+) in patients with AF. METHODS: A systematic search using bibliographic databases and gray literature was undertaken. Randomized and non-randomized controlled trials evaluating clinical efficacy, effectiveness, or safety of ablation procedures in adults with AF were included in this review. RESULTS: Of 3,204 potential citations identified by the original search, 21 randomized controlled trials and three non-randomized trials were included. Meta-analysis results reveal that in the first year after ablation, AF patients who underwent PVI+ strategies had a significantly higher rate of maintaining sinus rhythm than those who underwent PVI alone (RR 1.10, 95 % CI 1.02, 1.17). However, a subgroup meta-analysis was statistically significant for only PVI+ left atrial (LA) linear ablations (RR 1.16, 95 % CI 1.04, 1.29). The pooled success rates were higher in PVI+ group for both paroxysmal (RR 1.14, 95 % CI 1.06, 1.24) and non-paroxysmal AF (RR 1.53, 95 % CI 1.10, 2.14). CONCLUSION: PVI+ strategies, particularly PVI+ LA ablations, appear to result in higher success rates than PVI alone in the first year after the procedure. Studies of longer duration are needed to evaluate the long-term benefits and safety of different adjunctive ablation approaches for rhythm control in AF patients.

Patient management, and time and health care resource utilization associated with the use of intravenous bisphosphonates for patients with metastatic bone disease: a Delphi study.

OBJECTIVE: To identify patient management patterns in patients with solid tumors and metastatic bone disease who are receiving intravenous (IV) bisphosphonates (zoledronic acid and pamidronate), and to estimate the time and health care resources used for preparation and administration of zoledronic acid and pamidronate in patients with metastatic bone disease in Canada. METHODS: A modified 2-round Delphi technique was used, which was composed of 7 clinical experts. The first round was performed through telephone interviews with individual clinical experts to assess the management of patients with bone metastases receiving IV zoledronic acid and pamidronate. The interviews focused on qualitative issues, such as drugs administered, cancers identified, and the method of drug administration. The information obtained from the first round was used to describe typical patient management patterns. The information obtained from the second round was done by a face-to-face meeting involving all expert members, with the aim of confirming the management patterns, and identifying commonality and uniqueness across institutions. The time and health care resources needed for preparation and administration of the IV bisphosphonates were estimated. RESULTS: The expert panel comprised 4 pharmacists and 3 nurses from 2 centers in Ontario and 3 centers in Quebec. The main stages identified, which were associated with the preparation and administration of pamidronate and zoledronic acid, included preinfusion activities, IV access set-up, IV bisphosphonate preparation, chemotherapy infusion (if applicable), IV bisphosphonate infusion, and postinfusion activities. Five patient management patterns were identified and varied with respect to inclusion of chemotherapy and the use of ambulatory infusion devices. Without chemotherapy, the mean time for preparation and administration of zoledronic acid ranged from 38 minutes in a community service center to 85 minutes in a hospital-based cancer center. With chemotherapy, the total mean time increased to 119 minutes for patients with prostate cancer and 173 minutes for patients with breast cancer. The mean time for preparation and administration of pamidronate was 159 minutes with the use of a regular infusion device, and the time in the clinic was only 14 minutes with the use of an ambulatory infusion device. If chemotherapy was scheduled on the same visits, the mean time increased substantially, and varied depending on the type of cancer being treated. CONCLUSION: Preparation and administration of IV bisphosphonates are associated with notable burden to health care providers and patients, even if the waiting time, including preinfusion (eg, IV access set-up, serum creatinine level monitoring) and postinfusion activities, were excluded. Variations in the time and health care resources utilized for preparing and administering IV bisphosphonates were observed across the centers in Canada. The variation could be primarily due to the difference in patient management patterns.

Canadian cost-utility analysis of initiation and maintenance treatment with anti-TNF-α drugs for refractory Crohn's disease.

OBJECTIVES: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. Symptoms include but are not limited to abdominal pain, nausea, emesis, and diarrhea. Anti-TNF-α drugs are increasingly being used in patients with CD who have inadequate response to conventional therapy. However, these medications are quite expensive. The objective of this study is to evaluate the cost-utility of two anti-TNF-α drugs (infliximab, adalimumab) for refractory CD. METHODS: A Markov model was used to estimate the costs and QALYs of three treatments (usual care, infliximab, adalimumab) over a 5 year time horizon. After initial treatment, patients achieve remission, achieve treatment response or remain in the drug refractory health state. Patients who achieve remission or treatment response are at risk of relapse each 3 month model cycle. Patients in the drug refractory health state either remain in the health state or have surgery in each cycle. Different costs and utility values were assigned to the various model health states. Model input parameters including initial response rates, relapse rates, utility values were derived from published literature. RESULTS: Usual care had both the lowest expected costs ($17,017) and QALYs (2.555), while infliximab had both the highest expected costs ($54,084) and QALYs (2.721). The incremental cost per QALY moving from usual care to adalimumab and from adalimumab to infliximab was estimated to be to be $193,305 and $451,165, respectively. CONCLUSIONS: Based on common willingness to pay thresholds, ant-TNF-α drugs would not be perceived as a cost effective treatment for refractory CD.

Cost-utility of laparoscopic Nissen fundoplication versus proton pump inhibitors for chronic and controlled gastroesophageal reflux disease: a 3-year prospective randomized controlled trial and economic evaluation.

BACKGROUND: Very few randomized controlled trials (RCTs) have compared laparoscopic Nissen fundoplication (LNF) to proton pump inhibitors (PPI) medical management for patients with chronic gastroesophageal reflux disease (GERD). Larger RCTs have been relatively short in duration, and have reported mixed results regarding symptom control and effect on quality of life (QOL). Economic evaluations have reported conflicting results. OBJECTIVES: To determine the incremental cost-utility of LNF versus PPI for treating patients with chronic and controlled GERD over 3 years from the societal perspective. METHODS: Economic evaluation was conducted alongside a RCT that enrolled 104 patients from October 2000 to September 2004. Primary study outcome was GERD symptoms (secondary outcomes included QOL and cost-utility). Resource utilization and QOL data collected at regular follow-up intervals determined incremental cost/QALY gained. Stochastic uncertainty was assessed using bootstrapping and methodologic assumptions were assessed using sensitivity analysis. RESULTS: No statistically significant differences in GERD symptom scores, but LNF did result in fewer heartburn days and improved QOL. Costs were higher for LNF patients by $3205/patient over 3 years but QOL was also higher as measured by either QOL instrument. Based on total costs, incremental cost-utility of LNF was $29,404/QALY gained using the Health Utility Index 3. Cost-utility results were sensitive to the utility instrument used ($29,404/QALY for Health Utility Index 3, $31,117/QALY for the Short Form 6D, and $76,310/QALY for EuroQol 5D) and if current lower prices for PPIs were used in the analysis. CONCLUSIONS: Results varied depending on resource use/costs included in the analysis, the QOL instrument used, and the cost of PPIs; however, LNF was generally found to be a cost-effective treatment for patients with symptomatic controlled GERD requiring long-term management.

Patient outcomes after anti TNF-alpha drugs for Crohn's disease.

Crohn's disease (CD) is a chronic inflammatory bowel disease with a relatively high prevalence rate in North America. More than 50% of CD patients require surgery at some stage of their disease. Anti-TNF-alpha drugs are increasingly being used in patients with CD who have had an inadequate response to conventional therapy. Treatment with anti-TNF-alpha agents aims at improving symptom control and reducing the need for hospitalization and surgery. This review examines the clinical effectiveness of three anti-TNF-alpha agents (infliximab, adalimumab and etanercept) in moderate and severe CD. The review further considers the evidence for the harms and benefits associated with switching from one anti-TNF-alpha agent to another and strategies to optimize the timing of therapy.

Economic evaluation of drug-eluting stents compared to bare metal stents using a large prospective study in Ontario.

OBJECTIVES: To determine the cost-effectiveness (CE) and cost-utility (CU) of drug-eluting stents (DES) compared to bare metal stents (BMS) in Ontario using a large prospective "real-world" cohort study and determine the extent to which results vary by patient risk subgroups. METHODS: A field evaluation was conducted based on all stent procedures in the province of Ontario between December 1, 2003, and March 31, 2005, with a minimum subject follow-up of 1 year. Effectiveness data from the study using a propensity-score matched cohort were combined with resource utilization and cost data and quality of life (QOL) data from the published literature in a decision analytic modeling framework to determine 2-year cost-effectiveness (cost per revascularization avoided) and cost-utility (cost per quality-adjusted life-year ([QALY] gained). Stochastic model parameter uncertainty was expressed using probability distributions and analyzed using a probabilistic model. Modeling assumptions were assessed using traditional deterministic sensitivity analysis. RESULTS: Significant differences in revascularization rates were found for patients with two or more high risk factors. Despite these differences, the CE and CU of DES remained high (e.g., $419,000 per QALY gained in the most favorable patient risk subgroup). In sensitivity analysis, the difference in cost between DES and BMS had an impact on the CE and CU results. For example, at a price differential of $500, the CU of DES was $20,000/QALY for one patient subgroup and DES was dominant (i.e., less costly and more effective) in another. CONCLUSIONS: At current prices, the CE/CU of DES compared with BMS is high even in patient high risk subgroups. As the relative price of DES decrease, the value for money attractiveness of DES increases, especially for selected high risk patients.