Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial

Background: Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best practice model that applies major elements of case management, including patient education, can improve antithrombotic management in primary health care in terms of reducing major thromboembolic and bleeding events. Methods: This 24-month cluster-randomized trial will be performed in 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, health care assistants and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, health care assistants will be trained in case management and will use the Coagulation-Monitoring-List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment-as-usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization, and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients' assessment of chronic illness care, self-reported adherence to medication, general practitioners' and health care assistants' knowledge, patients' knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline (T0), follow-up after 12 (T1) and after 24 months (T2). Discussion: The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients and the methodological tool, case-management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment

Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia

<p>Abstract</p> <p>Background</p> <p>Postherpetic neuralgia (PHN) is a painful and difficult to treat complication of acute herpes zoster. Current treatment options provide only partial relief and are often limited by poor tolerability. We evaluated the safety and efficacy of a single 60-minute application of NGX-4010, an 8% capsaicin patch, in patients with PHN.</p> <p>Methods</p> <p>This multicenter, double-blind, controlled study randomized 155 patients 2:1 to receive either NGX-4010 or a 0.04% capsaicin control patch. Patients were at least 18 years old with PHN for at least 3 months, and an average Numeric Pain Rating Scale (NPRS) score of 3 to 9. The primary efficacy endpoint was the percentage change in NPRS score from baseline to weeks 2-8.</p> <p>Results</p> <p>The mean percent reduction in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 was greater in the NGX-4010 group (36.5%) compared with control (29.9%) although the difference was not significant (p = 0.296). PGIC analysis demonstrated that more NGX-4010 recipients considered themselves improved (much, or very much) compared with control at weeks 8 and 12, but the differences did not reach statistical significance. Post hoc analyses of patients with PHN for at least 6 months showed significantly greater reductions in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 in NGX-4010 patients compared to controls (37.6% versus 23.4%; p = 0.0291). PGIC analysis in this subgroup demonstrated that significantly more NGX-4010 recipients considered themselves much or very much improved compared with control at week 12 (40% versus 20%; p = 0.0403;).</p> <p>Conclusions</p> <p>Although treatment appeared to be safe and well tolerated, a single 60-minute application of NGX-4010 failed to show efficacy in this study which included patients with PHN for less than 6 months. Large reductions in pain observed among control patients with pain for less than 6 months may have been due to spontaneous resolution of PHN, may have confounded the results of the prespecified analyses, and should be taken into account when designing PHN studies.</p> <p>Trial Registration</p> <p>NCT00068081</p

Bridging health technology assessment (HTA) with multicriteria decision analyses (MCDA): field testing of the EVIDEM framework for coverage decisions by a public payer in Canada

<p>Abstract</p> <p>Background</p> <p>Consistent healthcare decisionmaking requires systematic consideration of decision criteria and evidence available to inform them. This can be tackled by combining multicriteria decision analysis (MCDA) and Health Technology Assessment (HTA). The objective of this study was to field-test a decision support framework (EVIDEM), explore its utility to a drug advisory committee and test its reliability over time.</p> <p>Methods</p> <p>Tramadol for chronic non-cancer pain was selected by the health plan as a case study relevant to their context. Based on extensive literature review, a by-criterion HTA report was developed to provide synthesized evidence for each criterion of the framework (14 criteria for the MCDA Core Model and 6 qualitative criteria for the Contextual Tool). During workshop sessions, committee members tested the framework in three steps by assigning: 1) weights to each criterion of the MCDA Core Model representing individual perspective; 2) scores for tramadol for each criterion of the MCDA Core Model using synthesized data; and 3) qualitative impacts of criteria of the Contextual Tool on the appraisal. Utility and reliability of the approach were explored through discussion, survey and test-retest. Agreement between test and retest data was analyzed by calculating intra-rater correlation coefficients (ICCs) for weights, scores and MCDA value estimates.</p> <p>Results</p> <p>The framework was found useful by the drug advisory committee in supporting systematic consideration of a broad range of criteria to promote a consistent approach to appraising healthcare interventions. Directly integrated in the framework as a "by-criterion" HTA report, synthesized evidence for each criterion facilitated its consideration, although this was sometimes limited by lack of relevant data. Test-retest analysis showed fair to good consistency of weights, scores and MCDA value estimates at the individual level (ICC ranging from 0.676 to 0.698), thus lending some support for the reliability of the approach. Overall, committee members endorsed the inclusion of most framework criteria and revealed important areas of discussion, clarification and adaptation of the framework to the needs of the committee.</p> <p>Conclusions</p> <p>By promoting systematic consideration of all decision criteria and the underlying evidence, the framework allows a consistent approach to appraising healthcare interventions. Further testing and validation are needed to advance MCDA approaches in healthcare decisionmaking.</p

Effect of preoperative patient expectations on outcomes after reverse total shoulder arthroplasty

© 2018 Journal of Shoulder and Elbow Surgery Board of Trustees Background: The purpose of this study was to determine the effect of preoperative expectations on outcomes after reverse shoulder arthroplasty (RSA). We hypothesized that patients with greater expectations would have better outcomes. Methods: Patients undergoing primary RSA completed the Hospital for Special Surgery\u27s Shoulder Expectations Survey preoperatively. Preoperative and 2-year postoperative clinical outcomes were measured with the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form, Shoulder Activity Scale (SAS), 36-Item Short Form Health Survey (SF-36), and visual analog scales (VASs). Pearson correlations were used to assess the relationship between the number of expectations and outcomes. Differences in outcomes between those with higher and lower levels of expectations for each expectation question were assessed by independent samples t test. Multivariable linear regression analysis was used to control for potential confounding factors. Results: We evaluated 135 patients at 2 years postoperatively. Patients had higher expectations for relieving pain, improving self-care, improving ability to perform daily activities, and improving ability to drive or put on a seatbelt. Patients with a greater number of high expectations preoperatively did not have better ASES, SAS, or VAS pain scores postoperatively. However, higher expectations for relieving nighttime pain was associated with ASES (β = 7.0, P =.048) and VAS pain scores (β = −5.9, P =.047) as well as 2-year improvement of VAS pain (β = −6.1, P =.039). Higher expectations for improving the ability to participate in nonoverhead sports was associated with improvements in SAS (β = 2.8, P =.020). Conclusion: A higher level of expectations for relief of nighttime pain and improving ability to participate in nonoverhead sports is associated with improved outcomes after RSA

Preoperative patient expectations of elective reverse shoulder arthroplasty.

BACKGROUND: The purpose of this study was to determine patients\u27 preoperative expectations before primary elective reverse shoulder arthroplasty (RSA). We hypothesized that younger patients, patients with better preoperative function, patients with shoulder osteoarthritis (OA), and patients with no prior joint replacements would have higher expectations of RSA. METHODS: We prospectively studied 333 primary RSAs performed for cuff tear arthropathy (n = 242), OA (n = 68), or post-traumatic arthritis (n = 23). Expectations were assessed preoperatively using the Hospital for Special Surgery\u27s shoulder surgery expectations survey. Preoperative patient-reported measures were assessed with the American Shoulder and Elbow Surgeons shoulder score; Shoulder Activity Scale score; Short Form 12 mental component and physical component scores; and visual analog scale scores for pain, fatigue, and general health. A Poisson regression model was performed to control for potential confounding variables. RESULTS: Relief of night-time pain, relief of daytime pain, improvement in self-care, improvement in the ability to drive or put on a seat belt, and improvement in the ability to perform daily activities were reported as very important by approximately half of patients. No association was found between age and overall expectations. Multivariate analysis showed that better preoperative Shoulder Activity Scale and Short Form 12 physical component scores were associated with greater expectations (P \u3c .001). OA was associated with greater expectations compared with cuff tear arthropathy (P \u3c .001). A history of either contralateral RSA or any joint replacement was associated with lower expectations (P \u3c .001). CONCLUSION: Patients have the highest expectations for pain relief and the performance of simple tasks after RSA. Patients with higher preoperative function, OA, and no previous joint replacements have greater expectations of RSA

Failed Proximal Humerus Osteosynthesis Using Intramedullary Fibular Strut Allograft Conversion to Reverse Shoulder Arthroplasty

© 2019 Wolters Kluwer Health, Inc. All rights reserved. Comminuted proximal humerus fractures are more frequently being treated utilizing an intramedullary fibular strut allograft to assist with open reduction internal fixation. Although this technique has led to improved outcomes, avascular necrosis, rotator cuff failure, and/or prominent hardware may still occur necessitating conversion to reverse shoulder arthroplasty. The presence of an intramedullary strut allograft makes this conversion technically demanding and creates certain potential complications unique to this group. This manuscript details the conversion of a proximal humerus open reduction internal fixation with a fibular strut allograft to reverse shoulder arthroplasty including presurgical workup, surgical techniques, and pitfalls for undertaking this increasingly common scenario

Predictors of patient satisfaction after reverse shoulder arthroplasty

© 2019 Journal of Shoulder and Elbow Surgery Board of Trustees Hypothesis: The aims of this study were to determine patient satisfaction and to identify predictors of satisfaction after reverse shoulder arthroplasty (RSA). We hypothesized that the majority of patients would be satisfied after RSA and that patients with worse preoperative mental and physical health would be less satisfied. Methods: Satisfaction was assessed 2 years after primary RSA with domains for pain, work, activities, quality of life, and overall satisfaction. Preoperative and postoperative patient-reported factors were measured using the American Shoulder and Elbow Surgeons (ASES) shoulder score, Shoulder Activity Scale score, Short Form 12 (SF-12) mental and physical component summary scores, and visual analog scale (VAS) pain, fatigue, and general health scores. Pearson correlations were used to determine the relationship between patient-reported factors and satisfaction. Multivariate regression was performed to control for potential confounding variables. Results: A total of 161 patients were evaluated at 2 years postoperatively. Patients were “very satisfied” in an average of 3.3 of the 5 domains. Improvements in ASES, Shoulder Activity Scale, VAS pain, and SF-12 physical component summary scores were associated with higher satisfaction, with correlation coefficients ranging from 0.27 to 0.49. On multivariate analysis, patients with higher preoperative ASES scores were less satisfied after surgery (P = .005). In addition, patients with worse VAS fatigue (P = .011) and SF-12 mental (P = .034) and physical (0.011) component summary scores preoperatively had lower satisfaction. Conclusion: Improvements in pain and outcome scores are associated with increased satisfaction. Patients with higher shoulder function, worse physical health, and worse mental health prior to surgery are more likely to have lower satisfaction after RSA