Objectives: When a new health technology has been approved by a health system, it is difficult to guarantee that it is going to be efficiently adopted, adequately used, and that effectiveness, safety, and consumption of resources and costs are in line with what was expected in preliminary investigations. Many governmental institutions promote the idea that efficient mechanisms should be established aimed at developing and incorporating continuous evidence into health technologies management. The purpose of this article is to stimulate the discussion on systematic post-introduction observation of health technologies.

Methods: Literature review and input of HTA experts.

Results: The study addresses the key issues related to post-introduction observation and presents a summary of the guide commissioned by the Spanish Ministry of Health, Social Policy and Equality to the Galician HTA agency for the prioritization and implementation of systematic post-introduction observation in Spain. The manuscript describes the prioritization tool developed as part of this project and discusses the main aspects of protocol development, observation implementation, and assessment of results.

Conclusions: The observation of prioritized health technologies after they are introduced in standard clinical practice can provide useful information for health organizations. However, implementing the observation of health technologies can require specific policy frameworks, commitment from different stakeholders, and dedicated funding.

Objectives: Although increasing effort is being devoted to developing strategies to increase knowledge transfer and the uptake of health technology assessment (HTA) by various stakeholders, very little is known about the utilization and dissemination of HTA findings by patient and consumer organizations. The goal of this study is to understand how and why patient and consumer organizations use HTA findings within their organizations, and what factors influence how and when they communicate their findings to members or other organizations.

Methods: We examined the use and dissemination of four controversial HTA reports by sixteen patient and consumer organizations in Ontario and Quebec. We gathered data from semistructured interviews conducted between December 2006 and April 2007.

Results: Although HTA findings are often used by the patient and consumer organizations, key differences were observed in exactly how the four HTA reports were used. Three types of use (instrumental, conceptual, and symbolic) are reported and illustrated. We highlight the importance of the organization's mission and knowledge base in explaining the types of use observed.

Conclusions: We contend that the use and dissemination of HTA reports by specific groups could help in widening the debate around controversial health technologies. The implications and opportunities for HTA agencies relate to the following: (i) identification of “lay” organizations that could help in disseminating results; (ii) acknowledgement of a “lay” audience for HTA findings; (iii) strategic inclusion of advocacy groups during the assessment process for highly controversial technologies; and (iv) contribution of these organizations to the push efforts of knowledge transfer.

We reviewed the 18 disease-specific evaluations that used the data base of the International Bone Marrow Transplant Registry to determine the effectiveness of alternative strategies for bone marrow transplant. We identify 17 treatment variables that physicians can control and report the associations between these variables and five clinical endpoints: stable engraftment, graft-versus-host disease, development of interstitial pneumonia, relapse, and disease-free survival. We also suggest policies to promote active participation in establishing and operating a registry.

The technology appraisal program of the National Institute for Clinical Excellence (NICE) was established on April 1, 1999. Its role is to advise the NHS in England and Wales on the clinical effectiveness, cost-effectiveness, and service impact of new and emerging as well as established healthcare technologies. This paper describes the role of HTA in the NICE technology appraisal process, discusses some of the challenges of the use of HTA in national policy making, and considers some of the potential ways forward.

This study compares the cost of antitumor therapy and adverse cardiovascular effects during the first year of treatment with either exogenous estrogens or orchidectomy of patients with prostatic cancer. We found that the higher costs for the orchidectomy patients were partially outweighed by the costs of treating cardiovascular complications in the estrogen-treated patients; the net overcost of orchidectomy is balanced after two and a half years by the ongoing costs of estrogen treatment. The fact that 25% of the patients treated with estrogen suffered cardiovascular complications, but no difference in mortality rates between the two groups was observed, speaks in favor of orchidectomy as the preferred treatment for prostatic carcinoma.

Patient involvement in the process of producing health technology assessments has become increasingly important. In the European Network for Health Technology Assessment (EUnetHTA), several approaches to patient involvement were explored. The outcome was a document on “Patient Input in Relative Effectiveness Assessments” that is available for access and was published in 2019.

The aim of this article is to analyze the experience gained by EUnetHTA in patient involvement for EUnetHTA assessment production, describe and quantify the approaches used, and outline the challenges and avenues for the improvement of current processes.

Patients were involved in twenty-three of thirty-six pharmaceutical and other technology EUnetHTA assessments from June 2016 until the end of November 2019. Approaches to patient involvement included using a patient input template, one-on-one conversations, group conversations, scoping meeting with patients, and other approaches.

Although it is recognized that patient involvement is important to understand the needs of the target patient population, challenges remain with timely patient involvement. Additionally, further efforts are needed to guide assessment teams on how to implement and enhance the visibility of patient input in assessments.

Objective: A recurring question is whether evidence from systematic reviews has any impact on medical practice. We have studied this question in relation to some conclusions in seven reports, where relatively simple means to monitor trends could be used.

Results: As recommended, in the report preoperative routines the number of preoperative examinations diminished at six hospitals, during around 3,000 operations studied, a savings of SEK 130 million. After the report on moderately elevated blood pressure sales of the preferred drugs, diuretics and beta-blockers, stopped falling while calcium blockers and ACE inhibitors stopped rising. As concluded in the report, general prostate cancer screening has not been introduced, but tests as a sign of opportunistic screening have increased. Bone density measurements were not recommended for screening, and sales of equipment have declined after the report. The use of neuroleptics as unspecific calming therapy for old persons was discouraged due to the serious side effects. The frequency of patients given this medication diminished from 34% to 28% at nursing homes after 1 year. For smoking cessation, the use of nicotine substitution medications has increased, which is in line with suggestions presented in the report. For stomach pain proton pump inhibitors given for functional dyspepsia have diminished in a region of the country after special efforts to disseminate the message.

Conclusions: It appears to be possible to monitor changes in practice corresponding to selected conclusions in systematic reviews. After rather extensive disseminating efforts, some results look encouraging.

Objectives: The aim of this study was to identify and critically appraise the use of Value of Information (VOI) analyses undertaken as part of health technology assessment (HTA) reports in England and Wales.

Methods: A systematic review of National Institute for Health Research (NIHR) funded HTA reports published between 2004 and 2013 identified the use of VOI methods and key analytical details in terms of: (i) types of VOI methodology used; (ii) parameters and key assumptions; and (iii) conclusions drawn in terms of the need for further research.

Results: A total of 512 HTA reports were published during the relevant timeframe. Of these, 203 reported systematic review and economic modeling studies and 25 of these had used VOI method(s). Over half of the twenty-five studies (n = 13) conducted both EVPI (Expected Value of Perfect Information) and EVPPI (Expected Value of Partial Perfect Information) analyses. Eight studies conducted EVPI analysis, three studies conducted EVPI, EVPPI, and EVSI (Expected Value of Sampling Information) analyses and one study conducted EVSI analysis only. The level of detail reporting the methods used to conduct the VOI analyses varied.

Conclusions: This review has shown that the frequency of the use of VOI methods is increasing at a slower pace compared with the published volume of HTA reports. This review also suggests that analysts reporting VOI method(s) in HTA reports should aim to describe the method(s) in sufficient detail to enable and encourage decision-makers guiding research prioritization decisions to use the potentially valuable outputs from quantitative VOI analyses.

Objectives: The UK National Institute for Health and Clinical Excellence (NICE) has been widely hailed as an international leader in health technology assessment. The objectives of its guidance are to ensure uniformity in healthcare provision, and promote a systematic and accountable way to allocate resources. However, research relating to the implementation of guidance is limited, and little is known about how it influences decision making at the consultation level or how useful it is to individual patients.

Methods: In-depth interviews were undertaken with professionals involved in healthcare provision at the community level, and with clinical professionals and patients providing or receiving care for morbid obesity and breast cancer (n = 52).

Results: Although NICE guidance was generally well-regarded, in practice it was of more importance and usefulness to managerial than clinical professionals. Clinicians used a patchy approach to implementation depending on whether recommendations accorded with their personal interpretation of the evidence available, and whether funding was available locally. Many patients had not heard of NICE, and clinical professionals did not alert them to its existence. Even where patients knew about relevant guidance, they were rarely able to use it to assert their right to treatment.

Conclusions: These findings challenge the perception that NICE guidance results in consistent and accountable decision making, and the limited accessibility and usefulness of guidance to patients suggests more information and support is needed at the point of provision if these objectives are to be achieved.

Objectives: The aim of this study was to evaluate the cost-effectiveness of on-site automated external defibrillators (AEDs) in the initial management of cardiac arrest in Ontario.

Methods: This was a cost-effectiveness analysis based on published literature and data from the Canadian Institute of Health Information. The participants were fictitious male and female cardiac arrest patients who were initially managed with on-site AEDs, compared with similar patients managed without on-site AEDs. This group included a subgroup of high-risk patients (i.e., heart failure and left ventricular ejection fraction <35 percent). The analysis was conducted in a variety of settings including hospitals and homes in Ontario, Canada. The main outcome evaluated was cost per quality-adjusted life-year (QALY) gained from a payer's perspective.

Results: Cost per QALY (all costs reported in Canadian dollars) was $12,768 when AEDs were deployed in hospitals, $511,766 when deployed in office buildings, $2,360,023 when deployed in apartment buildings, $87,569 when deployed in homes of high-risk patients, and $1,529,371 when deployed in homes of people older than 55 years of age.

Conclusions: Indiscriminate deployment of AEDs is not a cost-effective means of improving health outcomes of cardiac arrest. Their use should be restricted to emergency response programs, high-risk sites (such as hospitals), and high-risk patients.

This study discusses the value of primary data collection as part of health technology assessment (HTA). Primary data collection can help reduce uncertainty in HTA and better inform evidence-based decision making. However, methodological issues such as choosing appropriate study design and practical concerns such as the value of collecting additional information need to be addressed. The authors emphasize the conditions required for successful primary data collection in HTA: experienced researchers, sufficient funding, and coordination among stakeholders, government, and researchers. The authors conclude that, under specific conditions, primary data collection is a worthwhile endeavor in the HTA process.

We examined the use of percutaneous transluminal coronary angioplasty, kidney stone lithotripsy, and bone marrow transplant among patients with different health insurance plans in California. HMO enrollees were less likely to receive these procedures compared with fee-for-service patients. Our results have implications for the inflationary effects of technology under managed care.

Failures are inevitable in health care. When failure occurs as a result of practitioner error, quality in patient care may be compromised. This article proposes that analyzing clinical errors may contribute to quality assurance. Examples from physical therapy illustrate how information gained from analyzing errors can enhance patient care.

Objectives: The aim of this study is to examine key informants’ perceptions of how the New Zealand Pharmaceutical Management Agency (PHARMAC) operates in New Zealand.

Methods: We carried out qualitative analysis of semi-structured interviews with key informants. We obtained ethics approval from the University of Otago School of Pharmacy, and all participants gave informed consent. We digitally recorded the interviews, which were then transcribed, and coded in NVivo. The data were analyzed by theme using constant comparison methods. Twenty informants who had previously published research or commentary on New Zealand's access to medicines, acted as spokespersons for interest groups, or held positions that gave them key insights into New Zealand's medicines system agreed to participate. Informants were purposefully selected to ensure a wide range of views, including five people working in medicine, four in pharmacy, three Members of Parliament from different parties, and two each from PHARMAC and the pharmaceutical industry.

Results: Respondents saw PHARMAC as an organization that contained medicine costs effectively, was politically neutral, and resistant to lobbying. It enjoyed broad political support and, with extremely rare exceptions, had been allowed to carry out its functions independently regardless of who was in government. As a result of this political stability, the relationship between PHARMAC and the pharmaceutical industry has been improving.

Conclusion: PHARMAC's longevity and increasing influence are largely due to political choices made to prioritize containing pharmaceutical expenditure and to respecting PHARMAC's independence. This may be difficult to replicate in other countries.

Objectives: The primary objective of this study was to determine the extent to which international standards on transparency and quality are met by the health technology assessment (HTA) process in Poland. A secondary objective is to describe the outcomes of the HTA process and their associated factors.

Methods: All published online HTA appraisal and meeting proceedings on pharmaceutical products in 2008 were reviewed using a score card developed from international checklists recommended by INAHTA and ECHTA.

Results: The sixty-nine reports reviewed showed that five of nine transparency standards and six of eight quality standards were usually met by the HTA reports. Areas for improvement for transparency include inputs from external stakeholders, availability of English summaries, conclusions, implications of results, and suggested program of action. Areas of improvement for quality include appropriateness of target population and comparator/s, sufficiency of evidence on efficacy and safety, methodological rigor, economic model assumptions, and adaptation to the Polish setting. A consideration of the ethical and social consequences to the healthcare system must also be strengthened.

Conclusions: The study demonstrates that the incorporation and implementation of the HTA appraisal process in Poland has been successful. HTA appraisal reports in Poland have considered most of the international standards of transparency and quality. Recommendations for both HTA users and doers are forwarded for the improvement of the HTA process in the Polish setting.