Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol.

BACKGROUND: Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. METHODS: We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. DISCUSSION: Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

Adherence Over Time: The Course of Adherence to Customized Diabetic Insoles as Objectively Assessed by a Temperature Sensor.

BACKGROUND: Temperature sensors are an objective way to assess adherence to diabetic footwear. Good adherence is essential for the prevention of diabetic foot problems. Little is known about the long-term course of adherence in patients at risk for diabetic foot problems. METHOD: A temperature sensor was incorporated into the specialized footwear of patients with type 2 diabetes after their first plantar ulceration. Kaplan-Meier curve was used to analyze when patients started to become nonadherent (not wearing the footwear for two straight weeks). Gender effects on adherence were also analyzed. RESULTS: 26 patients with a mean observation time of 133.5 days could be analyzed. Mean wearing time of diabetic footwear was 4.2 ± 3.6 h/day (Mdn = 3.4 h/day; interquartile range = 0.5-7.0 h/day) and on 51% of the days patients did not wear their footwear at all. Kaplan-Meier curve revealed that the mean time of adherence was 27.5 weeks. Men achieved a mean time of adherence of 30.5 weeks, while women only achieved 14 weeks. However, due to the small sample size, this difference was not statistically significant. CONCLUSIONS: Temperature sensors revealed a low long-term adherence to diabetic footwear. Women seemed to be at a higher risk for earlier nonadherent behavior. Adherence to diabetic footwear should be closely monitored and tailored intervention strategies should be developed.

Cost-effectiveness of salt reduction to prevent hypertension and CVD: a systematic review.

OBJECTIVE: To analyse and compare the cost-effectiveness of different interventions to reduce salt consumption. DESIGN: A systematic review of published cost-effectiveness analyses (CEA) and cost-utility analyses (CUA) was undertaken in the databases EMBASE, MEDLINE (PubMed), Cochrane and others until July 2016. Study selection was limited to CEA and CUA conducted in member countries of the Organisation for Economic Co-operation and Development (OECD) in English, German or French, without time limit. Outcomes measures were life years gained (LYG), disability-adjusted life years (DALY) and quality-adjusted life years (QALY). Relevant aspects in modelling were analysed and compared. Quality assessments were conducted using the Drummond and Jefferson/British Medical Journal checklist. SETTING: OECD member countries. SUBJECTS: Mainly adults. RESULTS: Fourteen CEA and CUA were included in the review which analysed different strategies: salt reduction or substitution in processed foods, taxes, labelling, awareness campaigns and targeted dietary advice. Fifty-nine out of sixty-two scenarios were cost-saving. The incremental cost-effectiveness ratio in international dollars (Intl.$; 2015) was particularly low for taxes, a salt reduction by food manufacturers and labelling (303 900 Intl.$/DALY). However, only six studies analysed cost-effectiveness from a societal perspective and quality assessments showed flaws in conducting and a lack of transparency in reporting. CONCLUSIONS: A population-wide salt reduction could be cost-effective in prevention of hypertension and CVD in OECD member countries. However, comparability between study results is limited due to differences in modelling, applied perspectives and considered data.

Reform of prescription drug reimbursement and pricing in the German social health insurance market: a comparison of three scenarios.

We review regulation of two important parameters for third-party payers and manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA) countries. Compared with countries such as Switzerland, The Netherlands, France and England, regulation in the German social health insurance system is rather unique. First, market approval is nearly always equivalent to reimbursement. Second, manufacturers are free to determine prices but internal reference prices restrict them from actually doing so for generics and therapeutic substitutes. In order to contain rising expenditures for prescription drugs in Germany, and to set incentives for physicians to consider the costs as well as the benefits of prescriptions, three reform scenarios are feasible. The first scenario maintains centralised reimbursement and centralised pricing; the second maintains centralised reimbursement but switches to decentralised pricing (similar to social health insurance in Israel and Medicare in the US). Third-party payers would be able to negotiate with manufacturers about discounts and market shares for genetic and therapeutic substitutes. In the third scenario, pricing and reimbursement would be decentralised (similar to private health insurance in the US). We suggest that the second scenario is a viable compromise between consumer protection and a more competitive and cost-effective market for prescription drugs in German social health insurance and other similar markets for prescription drugs.

Criteria and procedures for determining benefit packages in health care. A comparative perspective.

The legitimacy of procedures and criteria for determining benefit packages depends crucially on the representation of stakeholders in decision-making bodies, the transparency of procedures and the consistency of benefit decisions. Moreover, the assessment of the costs of healthcare services and its application as a decision criterion can be an important policy instrument in order to increase the overall efficiency of healthcare systems. Our analysis of procedures and criteria for determining benefit packages in England, Germany and Switzerland established potential for developing more legitimate procedures and criteria for benefits decisions. In Germany, representation of stakeholders and transparency of procedures can be improved. Consistency of decision-making is hindered by the veto positions of selected stakeholders. Moreover, benefit decisions are made for different healthcare sectors separately. In Switzerland, transparency of procedures is virtually non-existent at the moment. Thus, it is impossible to assess the consistency of decision-making. Only in England the costs of healthcare services influence the decision to include or exclude them.