Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol.
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SUBMITTER: Mathes T
PROVIDER: S-EPMC5966916 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Introduction: Public health (PH) interventions are crucial for ensuring sustainable healthcare services. Nevertheless, they represent a neglected area in the field of health technology assessment (HTA) due to various methodological issues and their complex design that goes beyond clinical setting. The present study provides an environmental scan of HTA initiatives related to the assessment of PH technologies on a global level. Methods: We conducted a cross-sectional survey among 85 HTA-related European and international societies, health bodies, and networks from September 2018 to January 2019. The questionnaire contained four sections and 18 questions regarding activities related to the evaluation of PH technologies, information on existing PH technologies, and methodologies of assessment as well as barriers and facilitators to reaching a decision and implementing a PH technology. Results: Among 52 survey responses, the majority of the respondents came from European countries (35%), followed by North American (27%), and South American (19%) countries. The main type of organizations covered by our survey included HTA agencies, public administrations, and research institutes. Seventy-one % of the institutions reported engagement in any aspect of HTA in the area of PH (N = 37). Among those, 81% evaluated less than 5 PH technologies from 2013 to 2018. The most common barriers for reaching a decision on PH technologies were lack of data, conflicting stakeholder priorities, and methodological issues. A total of 76 PH interventions were reported, and most cited initiatives were related to chronic disease screening, prevention of infectious diseases, and maternal, prenatal, and neonatal screening. Conclusion: Our survey reported a rather limited involvement of HTA in the evaluation of PH technologies. In particular, an evaluation of behavioral and lifestyle interventions remains extremely rare. The implementation of collaborative HTA approaches in the setting of PH practice and policy needs to be prioritized and further strengthened. Moreover, ensuring reliable data structures and consolidation of HTA methods for the evaluation of PH technologies will be crucial for tackling the enormous burden of non-communicable diseases in societies.
| S-EPMC7188782 | biostudies-literature
Project description:IntroductionIn healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs.Method and analysisThis protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O'Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted.Ethics and disseminationThis scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.
| S-EPMC7705549 | biostudies-literature
Project description:INTRODUCTION:An interrupted time series (ITS) design is an important observational design used to examine the effects of an intervention or exposure. This design has particular utility in public health where it may be impracticable or infeasible to use a randomised trial to evaluate health system-wide policies, or examine the impact of exposures (such as earthquakes). There have been relatively few studies examining the design characteristics and statistical methods used to analyse ITS designs. Further, there is a lack of guidance to inform the design and analysis of ITS studies.This is the first study in a larger project that aims to provide tools and guidance for researchers in the design and analysis of ITS studies. The objectives of this study are to (1) examine and report the design characteristics and statistical methods used in a random sample of contemporary ITS studies examining public health interventions or exposures that impact on health-related outcomes, and (2) create a repository of time series data extracted from ITS studies. Results from this study will inform the remainder of the project which will investigate the performance of a range of commonly used statistical methods, and create a repository of input parameters required for sample size calculation. METHODS AND ANALYSIS:We will collate 200 ITS studies evaluating public health interventions or the impact of exposures. ITS studies will be identified from a search of the bibliometric database PubMed between the years 2013 and 2017, combined with stratified random sampling. From eligible studies, we will extract study characteristics, details of the statistical models and estimation methods, effect metrics and parameter estimates. Further, we will extract the time series data when available. We will use systematic review methods in the screening, application of inclusion and exclusion criteria, and extraction of data. Descriptive statistics will be used to summarise the data. ETHICS AND DISSEMINATION:Ethics approval is not required since information will only be extracted from published studies. Dissemination of the results will be through peer-reviewed publications and presentations at conferences. A repository of data extracted from the published ITS studies will be made publicly available.
| S-EPMC6352832 | biostudies-literature
Project description:BackgroundThe number of Health Technology Assessment (HTA) agencies increases. One component of HTAs are economic aspects. To incorporate economic aspects commonly economic evaluations are performed. A convergence of recommendations for methods of health economic evaluations between international HTA agencies would facilitate the adaption of results to different settings and avoid unnecessary expense. A first step in this direction is a detailed analysis of existing similarities and differences in recommendations to identify potential for harmonization. The objective is to provide an overview and comparison of the methodological recommendations of international HTA agencies for economic evaluations.MethodsThe webpages of 127 international HTA agencies were searched for guidelines containing recommendations on methods for the preparation of economic evaluations. Additionally, the HTA agencies were requested information on methods for economic evaluations. Recommendations of the included guidelines were extracted in standardized tables according to 13 methodological aspects. All process steps were performed independently by two reviewers.ResultsFinally 25 publications of 14 HTA agencies were included in the analysis. Methods for economic evaluations vary widely. The greatest accordance could be found for the type of analysis and comparator. Cost-utility-analyses or cost-effectiveness-analyses are recommended. The comparator should continuously be usual care. Again the greatest differences were shown in the recommendations on the measurement/sources of effects, discounting and in the analysis of sensitivity. The main difference regarding effects is the focus either on efficacy or effectiveness. Recommended discounting rates range from 1.5%-5% for effects and 3%-5% for costs whereby it is mostly recommended to use the same rate for costs and effects. With respect to the analysis of sensitivity the main difference is that oftentimes the probabilistic or deterministic approach is recommended exclusively. Methods for modeling are only described vaguely and mainly with the rational that the "appropriate model" depends on the decision problem. Considering all other aspects a comparison is challenging as recommendations vary regarding detailedness and addressed issues.ConclusionThere is a considerable unexplainable variance in recommendations. Further effort is needed to harmonize methods for preparing economic evaluations.
| S-EPMC3849629 | biostudies-literature
Project description:Introduction: An important requirement for successful public health interventions is a standardized classification in order to make these health technologies comparable in all contexts and recognized by all parties. The WHO International Classification of Health Interventions (ICHI), including an integrated public health component, has been developed to propose such an international standard. Methods: To test (a) the translation of public health interventions to ICHI codes and (b) the technical handling and general coding in public health, we used a set of public health interventions from a recent cross-sectional survey among Health Technology Assessment professionals. Results: Our study showed that handling of the ICHI interface is stable, that there is a need for specificity and adequate detail of intervention descriptions and desired outcomes to code adequately with ICHI and that the professional background of the coder, as well as his/her sex might influence the selection of codes. Conclusion: International Classification of Health Interventions provides a good coverage of public health interventions. However, the broader character of system wide interventions, often involving a variety of institutions and stakeholders, may present a challenge to the application of ICHI coding. Based on this experience, we would tailor future surveys more specifically to the needs of the classification and we advise training for health professionals before coding with ICHI. Standards of reporting will likely strengthen insights about the efficiency of primary prevention interventions and thus benefit long-term health of populations and structured HTA reporting process.
| S-EPMC8242241 | biostudies-literature
Project description:BackgroundAlthough nutrition interventions are a widely accepted resource for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential; however, it is complicated to implement. There is a need for products based on nutrition-related gene test results that are easily understood, accessible, and used.ObjectiveThe primary objective of this study was to compare a nonpractitioner-assisted direct-to-consumer self-driven approach to nutrigenomics versus an integrated and personalized practitioner-led method.MethodsThis 4-month study used a mixed-methods design that included (1) a phase 1 randomized controlled trial that examined the effectiveness of a multifaceted, nutrition-based gene test (components assessed included major nutrients, food tolerances, food taste and preferences, and micronutrients) in changing health behaviors, followed by (2) a qualitative investigation that explored participants' experiences. The study recruited 55 healthy males and females (aged 35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene test results plus integrated and personalized nutrition report) and 19 were assigned to the control group (gene test results report emailed). The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), changes in measures on General Self-efficacy and Health-Related Quality of Life scales, and anthropometrics (body mass index, waist-to-hip ratio) measured at baseline, post intervention (3 and 6 weeks), and the final visit (week 9 post intervention).ResultsOf the 478 individuals who expressed interest, 180 were invited (37.7%, 180/478) and completed the eligibility screening questionnaire; 73 of the 180 invited individuals (40.5%) were deemed eligible. Of the 73 individuals who were deemed to be eligible, 58 completed the baseline health questionnaire and food records (79%). Of these 58 individuals, 3 were excluded either because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%).ConclusionsThis study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. Although the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate show that there is a great degree of interest in this field. Given this interest and the fact that nutrigenomics is an evolving science, a need for continued research exists to further the understanding of the role of genetic variation and its role and applications in nutrition practice.Trial registrationClinicaltrials.gov NCT03310814; http://clinicaltrials.gov/ct2/show/NCT03310814 (Archived by WebCite at http://www.webcitation.org/6yGnU5deB).Registered report identifierRR1-10.2196/9846.
| S-EPMC6018240 | biostudies-literature
Project description:BACKGROUND:A recent study by Page et al. (PLoS Med. 2016;13(5):e1002028) claimed that increasing numbers of reviews are being published and many are poorly-conducted and reported. The aim of the present study was to assess how well reporting standards of systematic reviews produced in a Health Technology Assessment (HTA) context compare with reporting in Cochrane and other 'non-Cochrane' systematic reviews from the same years (2004 and 2014), as reported by Page et al. (PLoS Med. 2016;13(5):e1002028). METHODS:All relevant UK HTA programme systematic reviews published in 2004 and 2014 were identified. After piloting of the form, two reviewers each extracted relevant data on conduct and reporting from these reviews. These data were compared with data for Cochrane and "non-Cochrane" systematic reviews, as published by Page et al. (PLoS Med. 2016;13(5):e1002028). All data were tabulated and summarized. RESULTS:There were 30 UK HTA programme systematic reviews and 300 other systematic reviews, including Cochrane reviews (n?=?45). The percentage of HTA reviews with required elements of conduct and reporting was frequently very similar to Cochrane and much higher than all other systematic reviews, e.g. availability of protocols (90, 98 and 16% respectively); the specification of study design criteria (100, 100, 79%); the reporting of outcomes (100, 100, 78%), quality assessment (100, 100, 70%); the searching of trial registries for unpublished data (70, 62, 19%); reporting of reasons for excluding studies (91, 91 and 70%) and reporting of authors' conflicts of interests (100, 100, 87%). HTA reviews only compared less favourably with Cochrane and other reviews in assessments of publication bias. CONCLUSIONS:UK HTA systematic reviews are often produced within a specific policy-making context. This context has implications for timelines, tools and resources. However, UK HTA systematic reviews still tend to present standards of conduct and reporting equivalent to "gold standard" Cochrane reviews and superior to systematic reviews more generally.
| S-EPMC5941703 | biostudies-literature
Project description:Community pharmacies have great potential to deliver services aimed at promoting health and preventing disease, and are embedded within communities. In the light of a rapid increase in community pharmacy-delivered public health services and an accompanying increase in the evidence base, this systematic review of reviews will synthesise systematic reviews of public health community pharmacy interventions and assess their effects on public health and health inequalities.Systematic review methodology will be used to identify all systematic reviews that describe the health and health equity effects of community pharmacy public health interventions. Twenty databases will be searched using a pre-determined search strategy to evaluate community pharmacy-delivered public health interventions. Findings from the included reviews will be pooled, and a narrative synthesis executed to identify overarching patterns and results.Findings will support future decision-making around how community pharmacy public health services can be used alongside other strategies to promote health, prevent disease and reduce health inequalities.PROSPERO registration number: CRD42017056264 .
| S-EPMC5577831 | biostudies-other
Project description:OBJECTIVES:Physical rehabilitation is a complex process, and trials of rehabilitation interventions are increasing in number but often report null results. This study aimed to establish treatment success rates in physical rehabilitation trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme and examine any relationship between treatment success and the quality of intervention development work undertaken. DESIGN:This is a mixed methods study. SETTING:This study was conducted in the UK. METHODS:The NIHR HTA portfolio was searched for all completed definitive randomised controlled trials of physical rehabilitation interventions from inception to July 2016. Treatment success was categorised according to criteria developed by Djulbegovic and colleagues. Detailed textual data regarding any intervention development work were extracted from trial reports and supporting publications and informed the development of quality ratings. Mixed methods integrative analysis was undertaken to explore the relationship between quantitative and qualitative data using joint displays. RESULTS:Fifteen trials were included in the review. Five reported a definitive finding, four of which were in favour of the 'new' intervention. Eight trials reported a true negative (no difference) outcome. Integrative analysis indicated those with lower quality intervention development work were less likely to report treatment success. CONCLUSIONS:Despite much effort and funding, most physical rehabilitation trials report equivocal findings. Greater focus on high quality intervention development may reduce the likelihood of a null result in the definitive trial, alongside high quality trial methods and conduct.
| S-EPMC6720467 | biostudies-other
Project description:IntroductionRandomized controlled trials (RCTs) are the gold standard when comparing treatment effectiveness, and Health Technology Assessment (HTA) agencies state a clear preference for such direct comparisons. When these are not available, an indirect treatment comparison (ITC) is an alternative option. The objective of this study was to assess the acceptance of ITC methods by HTA agencies across England, France, Germany, Italy, and Spain, using oncology cases for a homogeneous sample of HTA evaluations.MethodsThe study was conducted on the PrismAccess database in May 2021 to retrieve HTA evaluation reports for oncology treatments for solid tumors, in which an ITC was presented. The analysis was restricted to HTA evaluation reports published between April 2018 and April 2021 in England, France, Germany, Italy, and Spain. Identified HTA evaluation reports were screened and reviewed by two independent reviewers. For each ITC presented, the methodology and its acceptance by the HTA agency were analyzed.ResultsFive hundred and forty-three HTA evaluation reports were identified, of which 120 (22%) presented an ITC. This proportion was the highest in England (51%) and lowest in France (6%). The overall acceptance rate of ITC methods was 30%, with the highest in England (47%) and lowest in France (0%). Network meta-analysis (NMA; 23%) was the most commonly used ITC technique, with a 39% acceptance rate overall, followed by Bucher ITC (19%; 43% acceptance rate) and matching-adjusted indirect comparison (13%; 33% acceptance rate). The most common criticisms of the ITC methods from HTA agencies related to data limitations (heterogeneity and lack of data; 48% and 43%, respectively) and the statistical methods used (41%).ConclusionsThe generally low acceptance rate of ITC methods by HTA agencies in oncology suggests that, whilst in the absence of a direct comparison ITCs may provide relevant evidence, this evidence is not widely considered sufficient for the purpose of HTA evaluations. The perception of ITC methods for the purpose of HTA evaluations varies substantially between countries. There is a need for further clarity on the properties of ITC techniques and the assessment of their results as ITC methods continue to evolve quickly and further techniques may become available in the future.
| S-EPMC10781913 | biostudies-literature