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.

Web-based interventions for the promotion of maternal mental health could represent a cost-effective strategy to reduce the burden associated with perinatal mental illness. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided web-based cognitive behavioral therapy intervention, compared with a waiting-list control.

The economic evaluation alongside a randomized controlled trial was conducted from a societal perspective over a 14-month time frame. Postpartum women presenting low risk for postpartum depression were randomized to the intervention (n = 191) or control (n = 176) group and assessed at baseline, postintervention and 4 and 12 months after postintervention. Data regarding healthcare use, productive losses and quality-adjusted life years (QALYs) were collected and used to calculate incremental cost-effectiveness ratios (ICERs). Uncertainty was accounted for with nonparametric bootstrapping and sensitivity analyses.

At 14 months, and after accounting for a 3.5 percent discount rate, the intervention resulted in a yearly cost-saving of EUR 165.47 (−361.77, 28.51) and a QALY gain of 0.0064 (−0.0116, 0.0244). Bootstrapping results revealed a dominant ICER for the intervention group. Although results were statistically nonsignificant, cost-effectiveness acceptability curves showed that at a EUR 0 willingness to pay threshold, there is a 96 percent probability that the intervention is cost-effective when compared with the control group. The sensitivity analyses generally supported the acceptable likelihood of the intervention being more cost-effective than the control group.

From a societal perspective, the implementation of Be a Mom among low-risk postpartum women could be a cost-effective way to improve perinatal mental health.

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.

Our aim was to assess the value of nintedanib for non-idiopathic progressive fibrosing interstitial lung disease (non-IPF PF-ILD) and systemic sclerosis-associated ILD (SSc-ILD) in the Spanish context, using a multi-criteria decision analysis (MCDA).

Following an adaptation of the Evidence and Value: Impact on DEcision Making (EVIDEM) MCDA methodology, the estimated value of nintedanib was obtained by means of an additive linear model that combined individual weights (100-points distribution) of criteria with the individual scoring of nintedanib in each criterion for every indication, assigned by a multidisciplinary committee of twelve clinicians, patients, pharmacists, and decision-makers. To assess the reproducibility, an alternative weighting method was applied, as well as a re-test of weights and scores at a different moment of time.

The experts committee recognized nintedanib as an intervention with a positive value contribution in comparison to placebo for the treatment of non-IPF PF-ILD (0.50 ± 0.16, on a scale from −1 to 1) and SSc-ILD (0.40 ± 0.12), diseases which were considered as very severe and with high unmet needs. The drug was perceived as a treatment that provides an added therapeutic benefit for patients (0.06–0.07), given its proven clinical efficacy (0.05–0.06), slight improvements in patient-reported outcomes (0.01–0.02), and similar safety profile than placebo (−0.04–0.00), which will likely be positioned as a recommended therapy in the next clinical practice guidelines updates.

Under this increasingly used methodology, nintedanib has shown to provide a positive value estimate for non-IPF PF-ILD and SSc-ILD when compared to placebo in Spain.

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.

To estimate the minimum percent change in failed extubation to make a tool designed to reduce extubation failure (Extubation Advisor [EA]) economically viable.

We conducted an early return on investment (ROI) analysis using data from intubated intensive care unit (ICU) patients at a large Canadian tertiary care hospital. We obtained input parameters from the hospital database and published literature. We ran generalized linear models to estimate the attributable length of stay, total hospital cost, and time to subsequent extubation attempt following failure. We developed a Markov model to estimate the expected ROI and performed probabilistic sensitivity analyses to assess the robustness of findings. Costs were presented in 2020 Canadian dollars (C$).

The model estimated a 1 percent reduction in failed extubation could save the hospital C$289 per intubated patient (95 percent CI: 197, 459). A large center seeing 2,500 intubated ICU patients per year could save C$723,124/year/percent reduction in failed extubation. At the current annual price of C$164,221, the EA tool must reduce extubation failure by at least 0.24 percent (95 percent CI: .14, .41) to make the tool cost-effective at our site.

Clinical decision-support tools like the EA may play an important role in reducing healthcare costs by reducing the rate of extubation failure, a costly event in the ICU.

There has been a lack of health technology assessment (HTA) methods for novel digital health technologies (DHTs) such as mHealth, artificial intelligence, and robotics in Finland. The Digi-HTA method has been developed for this purpose. The aim of this study is to determine whether it would be possible to use Digi-HTA recommendations to support healthcare decision-makers. Secondly, from the perspective of companies offering different types of DHT products, this study assesses the suitability of using the Digi-HTA framework to perform HTAs for their products.

Feedback about Digi-HTA recommendations was collected from healthcare professionals. DHT companies provided input about the Digi-HTA framework. Data were collected via a web-based survey and were analyzed using qualitative methods.

Of the twenty-four healthcare professional respondents, twenty said that the Digi-HTA recommendations contained all the necessary information, and twenty-one found them useful for their work. Respondents hoped that the Digi-HTA recommendations would be better integrated into the decision-making processes and healthcare professionals would be more informed about this new HTA process. The questions of the Digi-HTA framework were applicable for different DHT products based on the responses from DHT companies (n = 8).

According to the study participants, although the Digi-HTA recommendations include clear and beneficial information, their integration into healthcare decision-making processes should be improved. Responses from DHT companies indicate that the Digi-HTA framework would be an appropriate tool for performing assessments for their products. To generalize the findings of this study, more comprehensive studies will be needed.

Disinvestment from low value health technologies is growing globally. Diverse evidence gathering and assessment methods were used to implement disinvestment initiatives, however, less than half of the empirical studies report reduced use of the low-value services. This scoping review aimed to synthesize the information from available reviews on the concepts and purposes of disinvestment in healthcare, the approaches and methods used, the role of stakeholders and facilitators and barriers in its implementation.

This scoping review was guided by the Joanna Briggs Institute Manual for Evidence Synthesis and PRISMA statement for scoping review. Published reviews on disinvestment were identified from scientific databases including health technology assessment (HTA) Web sites using the terms “disinvestment,” “health technology reassessment,” and “healthcare.” The data obtained was synthesized narratively to identify similarities and differences across the approaches based on the prespecified categories.

Seventeen reviews were included with thirty-four initiatives identified across sixteen countries at various levels of implementation and responsible agencies for the activities. Two most used methods to facilitate disinvestment decisions are Programme Budgeting and Marginal Analysis (PBMA) and HTA. Stakeholder involvement is the most important aspect to be addressed, as it acts as both facilitator and barrier in disinvestment initiatives implementation.

Disinvestment programs have been implemented at multilevel, involving multistakeholders and using multiple methods such as PBMA and HTA. However, there is a lack of clarity on the additional dimensions of technical analysis related to these tools. Further research could focus on technology optimization in healthcare as part of overall health technology management.

To clarify the concept of disruptive technologies in health care, provide examples and consider implications of potentially disruptive technologies for health technology assessment (HTA).

We conducted a systematic review of conceptual and empirical papers on healthcare technologies that are described as “disruptive.” We searched MEDLINE and Embase from 2013 to April 2019 (updated in December 2021). Data extraction was done in duplicate by pairs of reviewers utilizing a data extraction form. A qualitative data analysis was undertaken based on an analytic framework for analysis of the concept and examples. Key arguments and a number of potential predictors of disruptive technologies were derived and implications for HTA organizations were discussed.

Of 4,107 records, 28 were included in the review. Most of the papers included conceptual discussions and business models for disruptive technologies; only few papers presented empirical evidence. The majority of the evidence is related to the US healthcare system. Key arguments for describing a technology as disruptive include improvement of outcomes for patients, improved access to health care, reduction of costs and better affordability, shift in responsibilities between providers, and change in the organization of health care. A number of possible predictors for disruption were identified to distinguish these from “sustaining” innovations.

Since truly disruptive technologies could radically change technology uptake and may modify provision of care patterns or treatment paths, they require a thorough evaluation of the consequences of using these technologies, including economic and organizational impact assessment and careful monitoring.

The aim of this scoping review is to map the available evidence about the use of health technology assessment (HTA) in the assessment of whole genome sequencing (WGS).

A scoping review methodology was adopted. The population, concept, and context framework was used to build up the research question and to establish the eligibility criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews was adopted to implement a comprehensive search strategy. Evidence was retrieved from scientific databases and HTA organizations Web sites. Reports were classified as full HTA, mini-HTA, rapid reviews or other.

The search strategy identified seven reports. Five HTA organizations from five countries elaborated the reports: one full HTA, four rapid reviews, and two classified as others. The reports were mainly focused on the evaluation of the clinical utility and cost-effectiveness of genome-wide sequencing as well as informing policy questions by providing analyses of organizational and ethical considerations.

Few HTA organizations are drafting reports for WGS. It is essential to stimulate a critical reflection during the elaboration of HTA reports for WGS to steer choices of decision makers in the establishment of priorities for research and policy and reimbursement rates.

To evaluate the cost-effectiveness of the nonsurgical periodontal treatment (NSPT) compared with supragingival therapy in type II diabetics with periodontitis.

A decision tree analysis was used to estimate the costs and health outcomes of two periodontal therapies in a hypothetical cohort of type II diabetics with periodontitis. The analysis was developed from the perspective of a third-party payer at 1 year and 5 years. Probabilities were derived from two systematic reviews. The costs and resource use were validated by a Delphi expert panel. All costs were expressed in USD, using the 25 May 2021 Colombian pesos market exchange rate (USD 1 = COP 3,350).

NSPT was a dominant alternative compared with subsidized supragingival therapy in type II diabetics with periodontitis, generating savings of USD 87 and 400, during the first year or up to 5 years, respectively, and improving dental survival from 32 to 69 percent.

NSPT can generate savings by reducing the complications derived from uncontrolled periodontitis and tooth loss.

Artificial intelligence (AI) is seen as a major disrupting force in the future healthcare system. However, the assessment of the value of AI technologies is still unclear. Therefore, a multidisciplinary group of experts and patients developed a Model for ASsessing the value of AI (MAS-AI) in medical imaging. Medical imaging is chosen due to the maturity of AI in this area, ensuring a robust evidence-based model.

MAS-AI was developed in three phases. First, a literature review of existing guides, evaluations, and assessments of the value of AI in the field of medical imaging. Next, we interviewed leading researchers in AI in Denmark. The third phase consisted of two workshops where decision makers, patient organizations, and researchers discussed crucial topics for evaluating AI. The multidisciplinary team revised the model between workshops according to comments.

The MAS-AI guideline consists of two steps covering nine domains and five process factors supporting the assessment. Step 1 contains a description of patients, how the AI model was developed, and initial ethical and legal considerations. In step 2, a multidisciplinary assessment of outcomes of the AI application is done for the five remaining domains: safety, clinical aspects, economics, organizational aspects, and patient aspects.

We have developed an health technology assessment-based framework to support the introduction of AI technologies into healthcare in medical imaging. It is essential to ensure informed and valid decisions regarding the adoption of AI with a structured process and tool. MAS-AI can help support decision making and provide greater transparency for all parties.

Wearable digital health technologies (DHTs) have the potential to improve chronic kidney disease (CKD) management through patient engagement. This study aimed to investigate and elicit preferences of individuals with CKD toward wearable DHTs designed to support self-management of their condition.

Using the results of our review of the published literature and after conducting qualitative patient interviews, five-choice attributes were identified and included in a discrete-choice experiment. The design consisted of 10-choice tasks, each comprising two hypothetical technologies and one opt-out scenario. We collected data from 113 adult patients with CKD stages 3–5 not on dialysis and analyzed their responses via a latent class model to explore preference heterogeneity.

Two patient segments were identified. In all preference segments, the most important attributes were the device appearance, format, and type of information provided. Patients within the largest preference class (70 percent) favored information provided in any format except the audio, while individuals in the other class preferred information in text format. In terms of the style of engagement with the device, both classes wanted a device that provides options rather than telling them what to do.

Our analysis indicates that user preferences differ between patient subgroups, supporting the case for offering a different design of the device for different patients’ strata, thus moving away from a one-size-fits-all service provision. Furthermore, we showed how to leverage the information from user preferences early in the R&D process to inform and support the provision of nuanced person-centered wearable DHTs.

The French health technology assessment (HTA) agency initiated a research between 2018 and 2019 with the aim of determining whether other HTA organizations (agencies, bodies, institutes, and expert networks) and researchers had developed an evaluation framework of organizational impacts (OIs).

Three types of investigation were carried out: (i) an analysis of documents published by selected HTA organizations, (ii) a rapid review on the OI issues, (iii) a questionnaire survey to experts of the International Network of Agencies for Health Technology Assessment.

The analyses highlight six key points: (i) there is no explicit conceptual definition of OIs; (ii) OIs are often not included in a specific dimension of the evaluation or in the same dimensions; (iii) three recurring categories emerge from the assessment of OIs: processes, structure, and culture; (iv) despite its limitations, the European Network for Health Technology Assessment framework (Core Model) is the most mature assessment model to date; (v) the question of the scope of OIs to be considered is unresolved (micro-meso-macro); and (vi) the delineation between OI assessment and economic assessment must be addressed.

Although the issue of considering OI in HTA has been raised for many years, it remains largely unresolved. Defining the concept of OI is a prerequisite for taking the next step toward an evaluation framework. As the question of the impact of innovation goes beyond the health sector, extensive research on how to define and take into account these OIs may be relevant.