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INDUSTRY'S EXPERIENCES WITH THE SCIENTIFIC ADVICE OFFERED BY THE FEDERAL JOINT COMMITTEE WITHIN THE EARLY BENEFIT ASSESSMENT OF PHARMACEUTICALS IN GERMANY.
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INDUSTRY'S EXPERIENCES WITH THE SCIENTIFIC ADVICE OFFERED BY THE FEDERAL JOINT COMMITTEE WITHIN THE EARLY BENEFIT ASSESSMENT OF PHARMACEUTICALS IN GERMANY.

Int J Technol Assess Health Care. 2018 Feb 19;:1-9

Authors: Dintsios CM, Schlenkrich S

Abstract
OBJECTIVES: Optional scientific advice (SA) for the early benefit assessment of pharmaceuticals is offered by the German decision maker, the Federal Joint Committee (FJC). The aim of this study was to elicit manufacturers' experiences with the SA procedures offered by the FJC to date.
METHODS: A preliminary survey on a small sample size was conducted. Subsequently, a questionnaire comprising eight items, which was developed on the basis of that survey, was used. Data were analyzed using qualitative and quantitative approaches.
RESULTS: The elicitation, including a sample of 25 percent of the completed advice, highlighted the following, regarding the process as well as to the content shortcomings of the SA procedures from an industrial perspective: inconsistencies, FJC's lack of expertise in conducting clinical trials, partially incomplete answers. and a low willingness of the FJC to engage in dialogue with industry were criticized. On the other hand, the majority of respondents expressed a positive attitude concerning unambiguousness, completeness, traceability, discussion atmosphere, and the protocol of the advice. Early SA, before pivotal trials start, showed a significantly higher completeness compared with late SA with respect to endpoints and study duration. Within 4 years the quality of FJC's propositions on some topics improved significantly.
CONCLUSIONS: Only a few statistically significant differences were detectable between early versus late SA. A positive trend in industry's perception of the SA can be observed over time. A more active involvement of additional stakeholders and the incorporation of procedural elements from other healthcare systems could improve the quality of the SA offered by the FJC.

PMID: 29455689 [PubMed - as supplied by publisher]




COST-UTILITY ANALYSIS OF PRIVATE CONTRACTING TO REDUCE PUBLIC WAITING TIMES FOR JOINT REPLACEMENT SURGERY.
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COST-UTILITY ANALYSIS OF PRIVATE CONTRACTING TO REDUCE PUBLIC WAITING TIMES FOR JOINT REPLACEMENT SURGERY.

Int J Technol Assess Health Care. 2018 Feb 19;:1-9

Authors: Karnon J, Haghighi BM, Sajjad B, Yem S, Gamage A, Thorpe A

Abstract
OBJECTIVES: Earlier treatment of publicly funded patients may achieve health gains that justify the additional costs of reducing waiting times. This study reports on the cost-effectiveness of implementing a private contracting model to meet alternative maximum waiting time targets for publicly funded patients undergoing total knee replacement surgery in Australia.
METHODS: A linked decision tree and cohort Markov model was developed and populated and validated using secondary data sources to represent the pathways, costs, and quality adjusted life-years (QALYs) gained of non-urgent patients with alternative waiting times for total knee replacement surgery to a maximum age of 100 years.
RESULTS: Assuming public waiting times are reduced through the purchase of private services, additional QALYs are gained at an incremental cost of less than $40,000. Value could be increased if lower private prices could be negotiated. Results are also sensitive to the rate of deterioration in function while waiting for surgery and the impact of functional status at the time of surgery on postsurgery outcomes.
CONCLUSIONS: More evidence on the value of expanded capacity or new models of care may inform new funding models to support such investments and reduced prices for new technologies, leading to more efficient and sustainable publicly funded healthcare systems.

PMID: 29455686 [PubMed - as supplied by publisher]




HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS.
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HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS.

Int J Technol Assess Health Care. 2018 Feb 19;:1-10

Authors: Vukovic V, Favaretti C, Ricciardi W, de Waure C

Abstract
OBJECTIVES: Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement.
METHODS: PubMed, ISI-WOS, and University of York - Centre for Reviews and Dissemination-electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model.
RESULTS: Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects.
CONCLUSIONS: E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

PMID: 29455685 [PubMed - as supplied by publisher]




OPTIMIZING USABILITY OF AN ECONOMIC DECISION SUPPORT TOOL: PROTOTYPE OF THE EQUIPT TOOL.
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OPTIMIZING USABILITY OF AN ECONOMIC DECISION SUPPORT TOOL: PROTOTYPE OF THE EQUIPT TOOL.

Int J Technol Assess Health Care. 2018 Feb 19;:1-10

Authors: Cheung KL, Hiligsmann M, Präger M, Jones T, Józwiak-Hagymásy J, Muñoz C, Lester-George A, Pokhrel S, López-Nicolás Á, Trapero-Bertran M, Evers SMAA, de Vries H

Abstract
OBJECTIVES: Economic decision-support tools can provide valuable information for tobacco control stakeholders, but their usability may impact the adoption of such tools. This study aims to illustrate a mixed-method usability evaluation of an economic decision-support tool for tobacco control, using the EQUIPT ROI tool prototype as a case study.
METHODS: A cross-sectional mixed methods design was used, including a heuristic evaluation, a thinking aloud approach, and a questionnaire testing and exploring the usability of the Return of Investment tool.
RESULTS: A total of sixty-six users evaluated the tool (thinking aloud) and completed the questionnaire. For the heuristic evaluation, four experts evaluated the interface. In total twenty-one percent of the respondents perceived good usability. A total of 118 usability problems were identified, from which twenty-six problems were categorized as most severe, indicating high priority to fix them before implementation.
CONCLUSIONS: Combining user-based and expert-based evaluation methods is recommended as these were shown to identify unique usability problems. The evaluation provides input to optimize usability of a decision-support tool, and may serve as a vantage point for other developers to conduct usability evaluations to refine similar tools before wide-scale implementation. Such studies could reduce implementation gaps by optimizing usability, enhancing in turn the research impact of such interventions.

PMID: 29455684 [PubMed - as supplied by publisher]