To investigate the test–retest reliability of the Costs for Patients Questionnaire (CoPaQ).

Through an online survey, individuals were invited to participate in a two-step study to assess the test–retest reliability of the CoPaQ. Participants to the first step were invited to complete the questionnaire a second time 2 weeks after. Reliability was assessed by calculating Cohen’s Kappa coefficients and intraclass correlation coefficients (ICC) for discrete and continuous data, respectively. A sensitivity analysis was carried out.

From a total of 1,200 participants who completed the first test, 403 completed the second test. The ICC varied from −0.00 to 0.98 with poor, moderate, good, and excellent results. The Kappa coefficients varied from −0.004 to 0.65 and were poor, slight, fair, moderate, and substantial. The sensitivity analysis showed the median value of ICC and Kappa coefficients for each category before and after the outliers’ exclusion. The median value of ICC changed from 0.30 (before) to 0.70 (after), and from 0.12 (before) to 0.04 (after), respectively, for each category. The median value of the Cohen’s Kappa coefficient increased from 0.44 (before) to 0.46 (after) and decreased from 0.32 (before) to 0.30 (after), respectively.

Test–retest reliability results indicated that the CoPaQ has a moderate reliability in terms of ICC and Kappa coefficients. The moderate reliability observed gives additional support for the applicability of this tool in economic evaluations of health interventions. Additional studies including on other properties and a cultural adaptation could further enhance the use of the tool.

Publication bias has the potential to adversely impact clinical decision making and patient health if alternative decisions would have been made had there been complete publication of evidence.

The objective of our analysis was to determine if earlier publication of the complete evidence on rosiglitazone’s risk of myocardial infarction (MI) would have changed clinical decision making at an earlier point in time. We tested several methods for adjustment of publication bias to assess the impact of potential time delays to identifying the MI effect. We then performed a cumulative meta-analysis (CMA) for both published studies (published-only data set) and all studies performed (comprehensive data set). We then created an adjusted data set using existing methods of adjustment for publication bias (Harbord regression, Peter’s regression, and the nonparametric trim and fill method) applied to the limited data set. Finally, we compared the time to the decision threshold for each data set using CMA.

Although published-only and comprehensive data sets did not provide notably different final summary estimates [OR = 1.4 (95 percent confidence interval [CI]: .95–2.05) and 1.42 (95 percent CI: 1.03–1.97)], the comprehensive data set reached the decision threshold 36 months earlier than the published-only data set. All three adjustment methods tested did not show a differential time to decision threshold versus the published-only data set.

Complete access to studies capturing MI risk for rosiglitazone would have led to the evidence reaching a clinically meaningful decision threshold 3 years earlier.

To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE.

Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results.

All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders’ definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines.

Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as “given”; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Argentina has a fragmented healthcare system with social security covering almost two thirds of the population. Its benefit package—called compulsory medical program (PMO; by its Spanish acronym Programa Médico Obligatorio)—has not been formally and widely updated since 2005. However, laws, clinical practice guidelines (CPGs), and a high-cost technology reimbursement fund complement it. Our objective was to comprehensively review such a PMO and propose an update considering the corresponding complementary sources.

We followed four steps: (i) identification of health technologies from the current PMO and complementary sources, (ii) prioritization, (iii) assessment through rapid health technology assessment (HTA), and (iv) appraisal and recommendations. We evaluated three value domains: quality of evidence, net benefit, and economics, which were summarized in a five-category recommendation traffic-light scale ranging from a strong recommendation in favor of inclusion to a strong recommendation for exclusion.

Eight hundred fifty technologies were identified; 164 of those, considered as high priority, were assessed through rapid HTAs. Those technologies mentioned in laws and CPGs were mostly outpatient essential medicines, whereas those from the reimbursement system were mostly high-cost drugs; of these 101 technologies, 50 percent were recommended to be kept in the PMO. The other 63 (identified by the Superintendence of Health Services, technology producers, and patients) were mostly medical procedures and high-cost drugs; only 25 percent of those resulted in a favorable recommendation.

A methodology based on four clearly identified steps was used to carry out a comprehensive review of an outdated and fragmented benefit package. The use of rapid HTAs and a traffic-light recommendation framework facilitated the deliberative evidence-based update.

While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The “South African Values and Ethics for Universal Health Coverage” (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts.

The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five.

The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context.

The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

In spring 2020, The European network for Health Technology Assessment (EUnetHTA) decided to join forces to produce best evidence to inform health policy in the COVID-19 pandemic. The objective of this paper is to describe the process and output of the coordinated and collaborative activities of EUnetHTA.

Relevant published and internal documents were retrieved for a descriptive analysis of EUnetHTA processes, methods, and outputs related to EUnetHTA’s response to the pandemic.

Process: In April 2020, a COVID-19 task force was set up and a survey collected pressing health policy questions across Europe. Two coordinating agencies for diagnostic tests and therapeutics were assigned. A process for prioritization and selection was set up for therapeutics, as well as explicit starting and stopping rules. Methodology: To increase a timely response, it was agreed that the rapid collaborative reviews (rapid CRs) would not require the consultation of manufacturers and the involvement of external experts, but would not differ in the methods and conduct of the systematic search, review, and synthesis of all available evidence, nor in the requirement for reviewing by EUnetHTA partners. Final reports: The joint effort resulted in the production of two rapid CRs on diagnostic tests, nineteen collaborative rolling reviews on therapeutics, three of which later moved to rapid CRs.

During COVID-19 pandemic, the EUnetHTA partners proved capable of prompt collaboration, which allowed speeding up the production and release of high-quality EUnetHTA outputs, while the relationships with the other European institutions facilitated their quick dissemination.

In model-based economic evaluations, the effectiveness parameter is often informed by studies with a limited duration of follow-up, requiring extrapolation of the treatment effect over a longer time horizon. Extrapolation from short-term data alone may not adequately capture uncertainty in that extrapolation. This study aimed to use structured expert elicitation to quantify uncertainty associated with extrapolation of the treatment effect observed in a clinical trial.

A structured expert elicitation exercise was conducted for an applied study of a podiatry intervention designed to reduce the rate of falls and fractures in the elderly. A bespoke web application was used to elicit experts’ beliefs about two outcomes (rate of falls and odds of fracture) as probability distributions (priors), for two treatment options (intervention and treatment as usual) at multiple time points. These priors were used to derive the temporal change in the treatment effect of the intervention, to extrapolate outcomes observed in a trial. The results were compared with extrapolation without experts’ priors.

The study recruited thirty-eight experts (geriatricians, general practitioners, physiotherapists, nurses, and academics) from England and Wales. The majority of experts (32/38) believed that the treatment effect would depreciate over time and expressed greater uncertainty than that extrapolated from a trial-based outcome alone. The between-expert variation in predicted outcomes was relatively small.

This study suggests that uncertainty in extrapolation can be informed using structured expert elicitation methods. Using structured elicitation to attach values to complex parameters requires key assumptions and simplifications to be considered.

Presenting an approach to synthesize quantitative and qualitative information from systematic reviews of multiple health interventions.

Within the context of an EUnetHTA multi-health technology assessment of twenty-three surgical techniques, we developed synthetic single tables, using color gradients and abbreviations, with information on which technologies had been compared, estimates of the size of differences for available comparisons, their clinical relevance, and certainty of the related evidence.

The proposed methodology provided, through a single depiction, information normally included in multiple figures/tables such as network plots, league tables, and summary of findings tables.

Transferring information on benefits, risks, and certainty of the available evidence on health interventions may be challenging, especially when assessing multiple treatments: more pieces of information need to be integrated in order to show an overall picture for each of the chosen outcomes, and usual reporting tools may be targeted to researchers more than to different kinds of decision makers. While more in-depth layers of information can always be added to satisfy needs of different audiences, the proposed tools could favor a quick interpretation of articulated scientific data by both decision makers and researchers.

Patient and public involvement (PPI) in the Brazilian Health Technology Assessment (HTA) process occurs in response to a legislative mandate for “social participation.” This resulted in some limited patient participation activities, and, therefore, a more systematic approach was needed. The study describes the development of a suggested framework for action to improve PPI in HTA.

This work used formal methodology to develop a PPI framework based on three-phase mixed-methods research with desktop review of Brazilian PPI activities in HTA; workshop, survey, and interviews with Brazilian stakeholders; and a rapid review of international practices to enact effective patient involvement. Patient partners reviewed the draft framework.

According to patient group representatives, their involvement in the Brazilian HTA process is important but could be improved. Different stakeholders perceived barriers, identified values, and made suggestions for improvement, such as expansion of communication, capacity building, and transparency, to support more meaningful patient involvement. The international practices identified opportunities for earlier, more active, and collaborative PPI during all HTA stages, based on values and principles that are relevant for Brazilian patients and the public. These findings were synthesized to design a framework that defines and systematizes actions to support PPI in Brazil, highlighting the importance of evaluating these strategies.

Since the publication of this framework, some of its suggestions are being implemented in the Brazilian HTA process to improve PPI. We encourage other HTA organizations to consider a systematic and planned approach with regular evaluation when pursuing or strengthening involvement practices.

Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil.

An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports.

We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence.

The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

In 2019, members of the Health Technology Assessment international (HTAi) Interest Group for Disinvestment and Early Awareness (DEA-IG) and the HTAi Interest Group for Information Retrieval (IR-IG) agreed to produce quarterly current awareness alerts for members of the DEA-IG. The purpose was to pilot a predefined strategy for sharing new publications on methods and topical issues in this area.

Literature search strategies for PubMed and Google were developed. Retrieved citations were posted on the DEA-IG Web site. Members of the DEA-IG received an email notification when new alerts were available. An informal survey of the DEA-IG members was used to provide feedback after the pilot.

Six alerts were issued during the pilot (June 2019–September 2020) with a total of 170 citations. The bulk of the information were 124 PubMed indexed citations, and of these, 96 were retrieved by the PubMed search strategies. Google searches were not found to be useful, but ongoing horizon scanning work at the Canadian Agency for Drugs and Technologies in Health (CADTH) provided additional information. Based on retrospective sorting, we considered thirty-five PubMed citations to be highly relevant for health technology assessment (HTA). The response rate to the survey was limited (seventeen respondents), but most respondents found the alerts useful for their work.

The results of this pilot project can be used to revise search strategies and information sources, improve the relevance of the alerts, and plan for expanded dissemination strategies.

We evaluated the early impact of a new hospital-based health technology assessment (HB-HTA) program, called Smart Innovation, at the University of Washington Medical Center (UWMC).

We compared the UWMC's utilization trends for two surgical procedures to control hospitals by evaluating the difference before and after adoption decisions: (i) a new filter for transcatheter aortic valve replacement (TAVR) procedures that treat aortic valve stenosis and (ii) microwave ablation (MWA) for treating hepatocellular carcinoma. We used descriptive statistics to assess the difference between the UWMC and controls for TAVR and MWA procedures and multivariate difference-in-differences (DID) analyses to test for statistical significance.

The UWMC experienced a 10 percent reduction in TAVR procedures compared with controls following the implementation of the TAVR Sentinel filter. The DID regression model indicated a 1.5 reduction in the number of TAVR procedures per quarter at the UWMC between the pre- and post period, which was not statistically significant (p-value: .87). The UWMC experienced a 51 percent reduction in utilization when compared with controls for MWA procedures in the pre- and post periods. The DID model for MWA indicated an 18.8 decrease in utilization per quarter during the study period for the UWMC, which was statistically significant (p-value: .0007). For MWA procedures, the UWMC experienced a $647,658 dollar reduction in total costs in the post period compared with controls.

When the UWMC used HB-HTA methods for technology adoption, there was a reduction in utilization and total costs when compared with controls; however, when the UWMC adopted a new technology without using HB-HTA methods, there was no difference in utilization.

Peer review of searches is a process whereby both the search strategies and the search process description are reviewed, ideally using an evidence-based checklist.

As the search strategy underpins any well-conducted evidence synthesis, its quality could affect the final result. Evidence shows, however, that search strategies are prone to error.

There is increasing awareness and use of the PRESS Evidence-Based Checklist and peer review of search strategies, at the outset of evidence syntheses, prior to the searches being run, and this is now recommended by a number of evidence synthesis organizations.

Searches for evidence syntheses should be peer reviewed by a suitably qualified and experienced librarian or information specialist after being designed, ideally, by another suitably qualified and experienced librarian or information specialist. Peer review of searches should take place at two important stages in the evidence synthesis process; at the outset of the project prior to the searches being run and at the prepublication stage. There is little empirical evidence, however, to support the effectiveness of peer review of searches. Further research is required to assess this. Those wishing to stay up to date with the latest developments in information retrieval, including peer review of searches, should consult the SuRe Info resource (http://www.sure-info.org), which seeks to help information specialists and others by providing easy access to the findings from current information retrieval methods research and thus support more research-based information retrieval practice.

The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation.

Several working groups defined processes and methods to support assessment teams in creating high-quality assessment reports. Existing guidelines, templates, and tools were refined and missing parts were newly created and integrated into the new QMS framework. EUnetHTA has contributed to Health Technology Assessment (HTA) capacity building through training and knowledge sharing. Continuous evaluation helped to identify gaps and shortcomings in processes and structures.

Based on a common quality management concept and defined development and revision procedures, twenty-seven partner organizations jointly developed and maintained around forty standard operating procedures and other components of the QMS. All outputs were incorporated into a web-based platform, the EUnetHTA Companion Guide, which was launched in May 2018. Concerted efforts of working groups were required to ensure consistency and avoid duplication.

With the establishment of a QMS for jointly produced assessment reports, EUnetHTA has taken a significant step toward a sustainable model for scientific and technical collaboration within European HTA. However, the definition of processes and methods meeting the numerous requirements of healthcare systems across Europe remains an ongoing and challenging task.

To describe the type and level of ethical integration in published health technology assessment (HTA) reports and systematically identify the ethical approaches utilized.

A literature search was conducted with the Google™ search engine using the keyword “ethic” between 1 January 2015 and 20 August 2019. Only HTA assessment reports with a section on ethics were retained and classified according to their level of ethical integration: no ethical analysis, ethical issues highlighted, assessments according to legal or social norms, and assessments from a moral or axiological perspective—using a qualitative methodology to distinguish such integration.

This review yielded 188 reports with a section identified as being on ethics, produced by seventeen HTA agencies in eleven countries. One hundred and thirty-six reports did not develop an ethical analysis, thirty-one highlighted ethical issues, seventeen conducted a norm-based ethical assessment using a descriptive approach grounded in social norms, and four developed an assessment grounded in a moral or axiological perspective. The bioethical “four-principles” framework was used, but mainly for presenting ethical issues and not as a moral framework.

The majority of reports featuring a section on ethics mention ethical considerations without ethical analysis. Ethical issues are grouped with legal, social, and organizational issues and treated as contextual considerations that decision makers should be aware of. When reports present systematic norm-based ethical assessments from a descriptive perspective or ethical assessment based on a moral or axiological perspective, there is a tendency to ground these analyses in frameworks created for the purpose and reliant on a concept of ethics supporting them.

This article aims to provide a brief review of information retrieval and hospital-based health technology assessment (HB-HTA) and describe library experiences and working methods at a regional HB-HTA center from the center's inception to the present day.

For this brief literature review, searches in PubMed and LISTA were conducted to identify studies reporting on HB-HTA and information retrieval. The description of the library's involvement in the HTA center and its working methods is based on the authors’ experience and internal and/or unpublished documents.

Region Västra Götaland is the second largest healthcare region in Sweden and has had a regional HB-HTA center since 2007 (HTA-centrum). Assessments are performed by clinicians supported by HTA methodologists. The medical library at Sahlgrenska University Hospital works closely with HTA-centrum, with one HTA librarian responsible for coordinating the work.

In the literature on HB-HTA, we found limited descriptions of the role librarians and information specialists play in different units. The librarians at HTA-centrum play an important role, not only in literature searching but also in abstract and full-text screening.

Methodologies of health technology assessment (HTA) for medical technologies are well established; yet, operational frameworks that enable appropriate uptake of HTA recommendations into routine clinical practice are lacking. This review aims to identify the key themes needed to guide the planning and implementation of HTA subsidy decisions for medical technologies such as diagnostics, medical devices, and services and to monitor their impact on a complex multipayer healthcare system like Singapore.

A literature search of implementation frameworks was conducted up to 20 December 2020 and was documented in a flow diagram. A thematic analysis of the evidence base was performed using the Braun and Clark approach to identify key themes, from which an implementation framework suitable for Singapore's healthcare system could be developed.

The searches yielded forty-four articles for review, from which twenty themes were identified. The top ten themes constituted the key themes of implementation essential for local adaptation and were categorized into five domains: implementation strategy, organizational support, stakeholder engagement, information dissemination, and implementation outcomes and evaluation. These domains provide operational guidance to methodically identify gaps to facilitate sustainable implementation of HTA-informed medical technology subsidy decisions.

A robust and adaptable implementation of HTA-informed subsidy decisions is crucial to optimize its intended impact of improving patient outcomes per dollar spent. The key themes of an implementation framework should capture the important aspects of organizational feasibility to ensure successful adoption in a complex multipayer healthcare system like Singapore.

Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step.

A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA.

ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value.

ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

Solutions like crowd screening and machine learning can assist systematic reviewers with heavy screening burdens but require training sets containing a mix of eligible and ineligible studies. This study explores using PubMed's Best Match algorithm to create small training sets containing at least five relevant studies.

Six systematic reviews were examined retrospectively. MEDLINE searches were converted and run in PubMed. The ranking of included studies was studied under both Best Match and Most Recent sort conditions.

Retrieval sizes for the systematic reviews ranged from 151 to 5,406 records and the numbers of relevant records ranged from 8 to 763. The median ranking of relevant records was higher in Best Match for all six reviews, when compared with Most Recent sort. Best Match placed a total of thirty relevant records in the first fifty, at least one for each systematic review. Most Recent sorting placed only ten relevant records in the first fifty. Best Match sorting outperformed Most Recent in all cases and placed five or more relevant records in the first fifty in three of six cases.

Using a predetermined set size such as fifty may not provide enough true positives for an effective systematic review training set. However, screening PubMed records ranked by Best Match and continuing until the desired number of true positives are identified is efficient and effective.

The Best Match sort in PubMed improves the ranking and increases the proportion of relevant records in the first fifty records relative to sorting by recency.

The Patient-Centered Outcomes Research Institute (PCORI) horizon scanning system is an early warning system for healthcare interventions in development that could disrupt standard care. We report preliminary findings from the patient engagement process.

The system involves broadly scanning many resources to identify and monitor interventions up to 3 years before anticipated entry into U.S. health care. Topic profiles are written on included interventions with late-phase trial data and circulated with a structured review form for stakeholder comment to determine disruption potential. Stakeholders include patients and caregivers recruited from credible community sources. They view an orientation video, comment on topic profiles, and take a survey about their experience.

As of March 2020, 312 monitored topics (some of which were archived) were derived from 3,500 information leads; 121 met the criteria for topic profile development and stakeholder comment. We invited fifty-four patients and caregivers to participate; thirty-nine reviewed at least one report. Their perspectives informed analyst nominations for fourteen topics in two 2019 High Potential Disruption Reports. Thirty-four patient stakeholders completed the user-experience survey. Most agreed (68 percent) or somewhat agreed (26 percent) that they were confident they could provide useful comments. Ninety-four percent would recommend others to participate.

The system has successfully engaged patients and caregivers, who contributed unique and important perspectives that informed the selection of topics deemed to have high potential to disrupt clinical care. Most participants would recommend others to participate in this process. More research is needed to inform optimal patient and caregiver stakeholder recruitment and engagement methods and reduce barriers to participation.