Integrating evidence on patient preferences in healthcare policy decisions

Background: Despite a strong movement towards active patient involvement in healthcare policy decisions, systematic and explicit consideration of evidence of this research on patient preferences seems limited. Furthermore, little is known about the opinions of several stakeholders towards consideration of research evidence on patient preferences in healthcare policy decisions. This paper describes the protocol for an explorative study on the integration of research on patient preferences in healthcare policy decisions. The study questions: to what extent research evidence on patient preferences is considered in current procedures for healthcare policy decisions; opinions of stakeholders regarding the integration of this type of evidence in healthcare policy decisions; and what could be a decision framework for the integration of such research evidence in healthcare policy decisions. Methods/design: The study is divided in three sub-studies, predominantly using qualitative methods. The first sub-study is a scoping review in five European countries to investigate whether and how results of research on patient preferences are considered in current procedures for coverage decisions and clinical practice guideline development. The second sub-study is a qualitative study to explore the opinions of stakeholders with regard to the possibilities for integrating evidence on patient preferences in the process of healthcare decision-making in the Netherlands. The third sub-study is the development of a decision framework for research on patient preferences. The framework will consist of: a process description regarding the place of evidence on patient preferences in the decision-making process; and a taxonomy describing different terminologies and conceptualisations of ‘preferences’ and an overview of existing methodologies for investigating preferences. The concept framework will be presented to and discussed with experts. Discussion: This study will create awareness regarding the existence and potential value of research evidence on patient preferences for healthcare policy decision-making and provides insight in the methods for investigating patient preferences and the barriers and facilitators for integration of such research in healthcare policy decisions. Results of the study will be useful for researchers, clinical practice guideline developers, healthcare policy makers, and patient representatives

Cost-Effectiveness and Cost-Utility of Early Levodopa in Parkinson's Disease

Background: In the Levodopa in EArly Parkinson's disease (LEAP) study, 445 patients were randomized to levodopa/carbidopa 100/25 mg three times per day for 80 weeks (early-start) or placebo for 40 weeks followed by levodopa/carbidopa 100/25 mg three times per day for 40 weeks (delayed-start).Objective: This paper reports the results of the economic evaluation performed alongside the LEAP-study.Methods: Early-start treatment was evaluated versus delayed-start treatment, in which the cost-effectiveness analysis (CEA) and the cost-utility analysis (CUA) were performed from the societal perspective, including health care costs among providers, non-reimbursable out-of-pocket expenses of patients, employer costs of sick leave, and lowered productivity while at work. The outcome measure for the CEA was the extra cost per unit decrease on the Unified Parkinson's Disease Rating Scale 80 weeks after baseline. The outcome measure for the CUA was the extra costs per additional quality adjusted life year (QALY) during follow-up.Results: 212 patients in the early-start and 219 patients in the delayed-start group reported use of health care resources. With savings of D 59 per patient (BCa 95% CI: -829, 788) in the early-start compared to the delayed-start group, societal costs were balanced. The early-start group showed a mean of 1.30 QALYs (BCa 95% CI: 1.26, 1.33) versus 1.30 QALYs (BCa 95% CI: 1.27, 1.33) for the delayed-start group. Because of this negligible difference, incremental cost-effectiveness and cost-utility ratios were not calculated.Conclusion: From an economic point of view, this study suggests that early treatment with levodopa is not more expensive than delayed treatment with levodopa.Neurological Motor Disorder

Evaluation of the ultrastructural and in vitro flow properties of the PRESERFLO MicroShunt

Purpose: To measure the in vitro flow properties of the PRESERFLO implant for comparison with the theoretical resistance to flow. Methods: The PRESERFLO was designed to control the flow of aqueous humor according to the Hagen-Poiseuille (HP) equation. Scanning electron microscopy (SEM) was performed to analyze the ultrastructure, and flow measurements were carried out using a gravity-flow setup. Results: SEM images of the PRESERFLO showed luminal diameters of 67.73 x 65.95 mu m and 63.66 x 70.54 mu m. The total diameter was 337.2 mu m, and the wall was 154 mu m wide. The theoretical calculation of the resistance to flow (R) for an aqueous humor (AH) viscosity of 0.7185 centipoises (cP) was 1.3 mm Hg/(mu L/min). Hence, assuming a constant AH flow of 2 mu L/min, the pressure differential across the device (AP) was estimated to be 2.6 mm Hg. The gravity-flow experiment allowed us to measure the experimental resistance to flow, which was R-E = 1.301 mm Hg/(mu L/min), in agreement with the theoretical resistance to flow R given by the HP equation. Conclusions: The experimental and theoretical flow testing showed that the pressure drop across this device would not be large enough to avoid hypotony unless the resistance to outflow of the sub-Tenon space was sufficient to control the intraocular pressure in the early postoperative period. Translational Relevance: The fluid properties of glaucoma subconjunctival drainage devices determine their specific bleb-forming capacity and ability to avoid hypotony and therefore their safety and efficacy profile. Translational Relevance: The fluid properties of glaucoma subconjunctival drainage devices determine their specific bleb-forming capacity and ability to avoid hypotony and therefore their safety and efficacy profile