Objective. The Patient Acceptable Symptom State (PASS) constitutes an absolute level of patient well-being and represents an ambitious target for disease management. We explored contributors to PASS, validated the PASS concept, and assessed thresholds of self-reported outcomes below which patients considered themselves in PASS. Methods. Patients with ankylosing spondylitis completed a questionnaire that included self-reported assessments of pain, fatigue, disease activity, function, patient global, quality of life (QOL), and whether they considered their current disease state satisfactory or not. Stepwise logistic regression was used to assess contributors to PASS. PASS was validated by analyzing proportions of patients reporting need for a rheumatologist and who were in current flare. PASS thresholds for self-reported outcomes were estimated using an anchoring method based on the patient's opinion and targeting the 75th percentile of the cumulative distribution. Results. PASS data were available for 291 patients, of whom 169 (58%) were in PASS.
BackgroundTNF (tumor necrosis factor)-alpha inhibitors block a key protein in the inflammatory chain reaction responsible for joint inflammation, pain, and damage in ankylosing spondylitis. ObjectivesTo assess the benefit and harms of adalimumab, etanercept, golimumab, and infliximab (TNF-alpha inhibitors) in people with ankylosing spondylitis.
This review found a substantial number of published cost-effectiveness analyses of drugs in osteoporosis in the last 6 years. Results and critical appraisal of these articles can help decision makers when prioritizing health interventions and can inform the development of future economic evaluations.
Objective The implementation of value‐based health care in inflammatory arthritis requires a standardized set of modifiable outcomes and risk‐adjustment variables that is feasible to implement worldwide. Methods The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary working group that consisted of 24 experts from 6 continents, including 6 patient representatives, to develop a standard set of outcomes for inflammatory arthritis. The process followed a structured approach, using a modified Delphi process to reach consensus on the following decision areas: conditions covered by the set, outcome domains, outcome measures, and risk‐adjustment variables. Consensus in areas 2 to 4 were supported by systematic literature reviews and consultation of experts. Results The ICHOM Inflammatory Arthritis Standard Set covers patients with rheumatoid arthritis (RA), axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis (JIA). We recommend that outcomes regarding pain, fatigue, activity limitations, overall physical and mental health impact, work/school/housework ability and productivity, disease activity, and serious adverse events be collected at least annually. Validated measures for patient‐reported outcomes were endorsed and linked to common reporting metrics. Age, sex at birth, education level, smoking status, comorbidities, time since diagnosis, and rheumatoid factor and anti‐citrullinated protein antibody lab testing for RA and JIA should be collected as risk‐adjustment variables. Conclusion We present the ICHOM inflammatory arthritis Standard Set of outcomes, which enables health care providers to implement the value‐based health care framework and compare outcomes that are important to patients with inflammatory arthritis.
Background Considering the heavy economic burden of osteoporotic fractures, the limits of healthcare resources, and the recent availability of new anti-osteoporosis drugs, there is continuing interest in economic evaluation studies of osteoporosis management strategies. Objectives This study aims to (1) systematically review recent economic evaluations of drugs for osteoporosis and (2) to apply an osteoporosis-specific guideline to critically appraise them. Methods A literature search was undertaken using PubMed, EMBASE, National Health Service Economic Evaluation database, and the Cost-Effectiveness Analysis Registry to identify original articles containing economic evaluations of anti-osteoporosis drugs, published between 1 July, 2013 and 31 December, 2019. A recent European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases-International Osteoporosis Foundation (ESCEO-IOF) guideline for the conduct and reporting of economic evaluations in osteoporosis was used to assess the quality of included articles. Results The database search retrieved 3860 records, of which 27 studies fulfilled the inclusion criteria. These studies were conducted in 15 countries; 12 active drugs were assessed, including various traditional pharmacological treatments such as bisphosphonates, raloxifene, strontium ranelate, denosumab, and teriparatide, and new agents such as abaloparatide, romosozumab, and gastro-resistant risedronate. Eight out of 12 studies that compared traditional oral bisphosphonates to other active interventions (denosumab, zoledronic acid, gastro-resistant risedronate, and teriparatide) suggested that the other active agents were generally cost-effective or dominant. Additionally, the cost-effectiveness of sequential therapy has recently been assessed and indications are that it can lead to extra health benefits (larger gains in quality-adjusted life-year). The key drivers of cost effectiveness included baseline fracture risk, drug effect on the risk of fractures, drug cost, and medication adherence/persistence. The current average score for quality assessment was 17 out of 25 (range 2-15); room for improvement was observed for most studies, which could potentially be explained by the fact that most studies were published prior to the osteoporosis-specific guideline. Greater adherence to guideline recommendations was expected for future studies. The quality of reporting was also suboptimal, especially with regard to treatment side effects, treatment effect after discontinuation, and medication adherence. Conclusions This updated review provides an overview of recently published cost-effectiveness analyses. In comparison with a previous review, recent economic evaluations of anti-osteoporosis drugs were conducted in more countries and included more active drugs and sequential therapy as interventions/comparators. The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporo...
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