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Examining Tensions That Affect the Evaluation of Technology in Health Care: Considerations for System Decision Makers From the Perspective of Industry and Evaluators.

ABSTRACT: Virtual technologies have the potential to mitigate a range of challenges for health care systems. Despite the widespread use of mobile devices in everyday life, they currently have a limited role in health service delivery and clinical care. Efforts to integrate the fast-paced consumer technology market with health care delivery exposes tensions among patients, providers, vendors, evaluators, and system decision makers. This paper explores the key tensions between the high bar for evidence prior to market approval that guides health care regulatory decisions and the "fail fast" reality of the technology industry. We examine three core tensions: balancing user needs versus system needs, rigor versus responsiveness, and the role of pre- versus postmarket evidence generation. We use these to elaborate on the structure and appropriateness of evaluation mechanisms for virtual care solutions. Virtual technologies provide a foundation for personalized, patient-centered medicine on the user side, coupled with a broader understanding of impact on the system side. However, mechanisms for stakeholder discussion are needed to clarify the nature of the health technology marketplace and the drivers of evaluation priorities.

SUBMITTER: Desveaux L

PROVIDER: S-EPMC5741827 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Examining Tensions That Affect the Evaluation of Technology in Health Care: Considerations for System Decision Makers From the Perspective of Industry and Evaluators.

Desveaux Laura L Shaw James J Wallace Ross R Bhattacharyya Onil O Bhatia R Sacha RS Jamieson Trevor T

JMIR medical informatics 20171208 4

Virtual technologies have the potential to mitigate a range of challenges for health care systems. Despite the widespread use of mobile devices in everyday life, they currently have a limited role in health service delivery and clinical care. Efforts to integrate the fast-paced consumer technology market with health care delivery exposes tensions among patients, providers, vendors, evaluators, and system decision makers. This paper explores the key tensions between the high bar for evidence prio ...[more]

PMID: 29222075

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Project description:BackgroundNew artificial intelligence (AI) tools are being developed at a high speed. However, strategies and practical experiences surrounding the adoption and implementation of AI in health care are lacking. This is likely because of the high implementation complexity of AI, legacy IT infrastructure, and unclear business cases, thus complicating AI adoption. Research has recently started to identify the factors influencing AI readiness of organizations.ObjectiveThis study aimed to investigate the factors influencing AI readiness as well as possible barriers to AI adoption and implementation in German hospitals. We also assessed the status quo regarding the dissemination of AI tools in hospitals. We focused on IT decision makers, a seldom studied but highly relevant group.MethodsWe created a web-based survey based on recent AI readiness and implementation literature. Participants were identified through a publicly accessible database and contacted via email or invitational leaflets sent by mail, in some cases accompanied by a telephonic prenotification. The survey responses were analyzed using descriptive statistics.ResultsWe contacted 609 possible participants, and our database recorded 40 completed surveys. Most participants agreed or rather agreed with the statement that AI would be relevant in the future, both in Germany (37/40, 93%) and in their own hospital (36/40, 90%). Participants were asked whether their hospitals used or planned to use AI technologies. Of the 40 participants, 26 (65%) answered "yes." Most AI technologies were used or planned for patient care, followed by biomedical research, administration, and logistics and central purchasing. The most important barriers to AI were lack of resources (staff, knowledge, and financial). Relevant possible opportunities for using AI were increase in efficiency owing to time-saving effects, competitive advantages, and increase in quality of care. Most AI tools in use or in planning have been developed with external partners.ConclusionsFew tools have been implemented in routine care, and many hospitals do not use or plan to use AI in the future. This can likely be explained by missing or unclear business cases or the need for a modern IT infrastructure to integrate AI tools in a usable manner. These shortcomings complicate decision-making and resource attribution. As most AI technologies already in use were developed in cooperation with external partners, these relationships should be fostered. IT decision makers should assess their hospitals' readiness for AI individually with a focus on resources. Further research should continue to monitor the dissemination of AI tools and readiness factors to determine whether improvements can be made over time. This monitoring is especially important with regard to government-supported investments in AI technologies that could alleviate financial burdens. Qualitative studies with hospital IT decision makers should be conducted to further explore the reasons for slow AI.

Project description:BACKGROUND:Knowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and increase knowledge of how to attract and retain industry-sponsored trials. Accordingly, we investigated which site-related qualities multinational biopharmaceutical companies and clinical research organizations (CROs) find most important during site selection. METHODS:An online survey among decision-makers for trial site selection in the Nordic countries employed at multinational biopharmaceutical companies and CROs was conducted. The respondents' experiences with and perceptions of site selection were addressed to evaluate the relative importance of site-related qualities. We included up to four respondents per company, representing different geographic regions. Descriptive statistics were used to summarize findings. RESULTS:Of 49 eligible companies, 20 biopharmaceutical companies and 23 CROs participated. In total, 83 responses were analyzed (estimated response rate 78%). A relative importance of site-related qualities was identified: For example, 88% (binomial 95% confidence interval [CI] ±7%) preferred reaching enrollment goals at trial sites in their region 10% quicker rather than cutting the costs at all sites by 20%. Likewise, 42% (CI ±11%) of the respondents preferred that trial sites were best at having the first patients ready for inclusion right after site initiation visit compared to having good data entry, documentation, and reporting practice (25% [CI ±9%]), easily reachable site personnel and backup (23% [CI ±9%]), fast contractual procedure times (6% [CI ±5%]), a key opinion leader associated with the site (3% [CI ±4%]), and updated equipment and facilities (1% [CI ±2%]). In total, 75% [CI ±9%] agreed that their company would be interested in cooperating with an inexperienced trial site if the site had access to a large patient population and 52% [CI ±11%] had experienced that their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment. CONCLUSIONS:This study indicates that recruitment-related factors are pivotal to the pharmaceutical industry when assessing trial sites during site selection. Data quality-related factors seem highly valued especially in early phase trials whereas costs and investigator's publication track record are less important. Experience in conducting clinical trials is not imperative. However, this applies primarily to late phase trials.

Project description:BackgroundMigraine is the world's second most common disabling disorder, affecting 15% of UK adults and costing the UK over £1.5 billion per year. Several costly new drugs have been approved by National Institute for Health and Care Excellence.AimTo assess the cost-effectiveness of drugs used to treat adults with chronic migraine.MethodsWe did a systematic review of placebo-controlled trials of preventive drugs for chronic migraine. We then assessed the cost-effectiveness of the currently prescribable drugs included in the review: Onabotulinum toxin A (BTA), Eptinezumab (100mg or 300mg), Fremanezumab (monthly or quarterly dose), Galcanezumab or Topiramate, each compared to placebo, and we evaluated them jointly. We developed a Markov (state-transition) model with a three-month cycle length to estimate the costs and quality-adjusted life years (QALYs) for the different medications from a UK NHS and Personal Social Services perspective. We used a two-year time horizon with a starting age of 30 years for the patient cohort. We estimated transition probabilities based on monthly headache days using a network meta-analysis (NMA) developed by us, and from published literature. We obtained costs from published sources and applied discount rates of 3.5% to both costs and outcomes.ResultsDeterministic results suggest Topiramate was the least costly option and generated slightly more QALYs than the placebo, whereas Eptinezumab 300mg was the more costly option and generated the most QALYs. After excluding dominated options, the incremental cost-effectiveness ratio (ICER) between BTA and Topiramate was £68,000 per QALY gained and the ICER between Eptinezumab 300mg and BTA was not within plausible cost-effectiveness thresholds. The cost-effectiveness acceptability frontier showed that Topiramate is the most cost-effective medication for any amount the decision maker is willing-to-pay per QALY.ConclusionsAmong the various prophylactic medications for managing chronic migraine, only Topiramate was within typical cost-effectiveness threshold ranges. Further research is needed, ideally an economic evaluation alongside a randomised trial, to compare these newer, expensive CGRP MAbs with the cheaper oral medications.

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Examining Tensions That Affect the Evaluation of Technology in Health Care: Considerations for System Decision Makers From the Perspective of Industry and Evaluators.

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Examining Tensions That Affect the Evaluation of Technology in Health Care: Considerations for System Decision Makers From the Perspective of Industry and Evaluators.

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