Assessing the value of healthcare innovations: a proposal for an integrated health technology assessment-responsible innovation in health approach in the "new normal".

There has been tremendous technological innovation in the healthcare sector, but it has also raised serious ethical and social concerns. The COVID-19 pandemic has only magnified these existing challenges. Hence, addressing these challenges becomes imperative in the "new normal." In this context, this article uses a narrative synthesis approach to discuss the linkages of health technology, innovation, and policy to identify the challenges of this complex interaction by applying the principles of pragmatism and historicity to the existing literature. Moreover, the existing scientific mechanisms in the form of health technology assessment (HTA) and responsible innovation in health (RIH) are described to address these challenges. Using inductive epistemology, the linkages between HTA and RIH within a health innovation ecosystem framework are discussed for the future application of an integrated approach to address societal challenges. The proposed integrated approach of HTA and RIH is a work in progress and conceptualized as transdisciplinary, flexible, and adaptive, which is expected to facilitate future discussion, research, and policy action.

The qualitative experience of telehealth access and clinical encounters in Australian healthcare during COVID-19: implications for policy.

BACKGROUND: Adaptive models of healthcare delivery, such as telehealth consultations, have rapidly been adopted to ensure ongoing delivery of essential healthcare services during the COVID-19 pandemic. However, there remain gaps in our understanding of how clinicians have adapted to telehealth. This study aims to explore the telehealth experiences of specialists, based at a tertiary hospital in the Hunter Region, and general practitioners (GP), including barriers, enablers and opportunities. METHODS: An interpretative qualitative study involving in-depth interviews explored the telehealth experiences of specialists, based at a tertiary hospital in the Hunter Region of Australia, and GPs, including barriers, enablers and opportunities. Data were analysed using an inductive thematic approach with constant comparison. RESULTS: Individual interviews were conducted with 10 specialists and five GPs. Key themes were identified: (1) transition to telehealth has been valuable but challenging; (2) persisting telehealth process barriers need to be addressed; (3) establishing when face-to-face consults are essential; (4) changes in workload pressures and potential for double-up; (5) essential modification of work practices; and (6) exploring what is needed going forward. CONCLUSIONS: While there is a need to rationalize and optimize health access during a pandemic, we suggest that more needs to be done to improve telehealth going forward. Our results have important policy implications. Specifically, there is a need to effectively train clinicians to competently utilize and be confident using this telehealth and to educate patients on necessary skills and etiquette.

'All the stars were aligned'? The origins of England's National Institute for Health Research.

BACKGROUND: In 2006, the research and development (R&D) activity of England's national healthcare system, the National Health Service, was reformed. A National Institute for Health Research (NIHR) was established within the Department of Health, the first body to manage this activity as an integrated system, unlocking significant increases in government funding. This article investigates how the NIHR came to be set up, and why it took the form it did. Our goal was a better understanding of 'how we got here'. METHODS: We conducted oral history interviews with 38 key witnesses, held a witness seminar, and examined published and unpublished documents. RESULTS: We conclude that the most important forces shaping the origin of NIHR were the growing impact of evidence-based medicine on service policies, the growth of New Public Management ways of thinking, economic policies favouring investment in health R&D and buoyant public funding for healthcare. We note the strong two-way interaction between the health research system and the healthcare system - while beneficial for the use of research, challenges for healthcare (such as stop-go funding) could also produce challenges for health research. CONCLUSIONS: Understanding how and why England came to have a centralised health service research system alongside a long-established funder of biomedical research (the Medical Research Council) helps us interpret the significance of the English health research experience for other countries and helps English policy-makers better understand their present options. Learning lessons from the features of the English health research system calls for an understanding of the processes which shaped it. Firstly, the publicly funded, nationally organised character of healthcare promoted government interest in evidence-based medicine, made research prioritisation simpler and helped promote the implementation of findings. Secondly, the essential role of leadership by a group who valued research for its health impact ensured that new management methods (such as metrics and competitive tendering) were harnessed to patient benefit, rather than as an end in themselves. A policy window of government willingness to invest in R&D for wider economic goals and buoyant funding of the health system were also effectively exploited.

A novel approach to sharing all available information from funded health research: the NIHR Journals Library.

BACKGROUND: Relevant information on health research must be made publicly available in an accurate, timely and accessible manner if evidence is to inform practice and benefit patient care. Failure to publish research information represents a significant waste of research funds. However, recent studies have demonstrated that non-publication and selective or biased reporting remains a significant problem. The role of online publications in rectifying these issues by providing open access to study information is increasingly recognised. OBJECTIVE: This paper details a novel approach to publishing research information developed by the National Institute for Health Research (NIHR), a major funder of health research in the United Kingdom. The NIHR has enhanced its Journals Library ( www.journalslibrary.nihr.ac.uk ), providing an online repository of information from research funded through five programmes. We describe how the NIHR Journals Library provides a 'thread' of relevant information for each study, including protocols, participant information sheets, data linkages, final reports, publications and diverse knowledge products. We also discuss the Library as a 'living' resource, one that is updated as each study progresses from inception to completion. Finally, we consider the implications of the Library for the NIHR, other journals and research teams submitting information. CONCLUSION: Openly publishing information from funded research in the NIHR Journals Library serves as a model of knowledge sharing, maximising return on investment and enhancing the usability and replicability of research findings for different evidence-user communities. The Library also supports wider 'research on research' ambitions, enabling users to interrogate the repository of NIHR-funded studies, enhancing the understanding of research commissioning, design, dissemination and impact. Video abstract: www.youtube.com/watch?v=8H03uxN_iTE .

Publicly funded practice-oriented clinical trials: of importance for healthcare payers.

AIM: Many questions of relevance to patients/society are not answered by industry-sponsored clinical trials. We consider whether there are benefits to governments in funding practice-oriented clinical trials. METHODOLOGY: A literature search including publications on institutions' websites was performed and supplemented with information gathered from (inter)national stakeholders. RESULTS: Areas were identified where public funding of clinical trials is of importance for society, such as head-to-head comparisons or medical areas where companies have no motivation to invest. The available literature suggests publicly funded research programs could provide a positive return on investment. The main hurdles (e.g., sufficient funding and absence of equipoise) and success factors (e.g., selection of research questions and research infrastructure) for the successful conduct of publicly funded trials were identified. CONCLUSION: Governments should see public funding of pragmatic practice-oriented clinical trials as a good opportunity to improve the selection and quality of treatments and stimulate efficient use of limited resources.

Patients' expectations of medicines--a review and qualitative synthesis.

BACKGROUND: An increasing part of prescribing of medicines is done for the purpose of managing risk for disease and is motivated by clinical and economic benefit on a long-term, population level. This makes benefit from medicines less tangible for individuals. Sociology of pharmaceuticals includes personal and social perspectives in the study of how medicines are used. We use two characterizations of patients' expectations of medicines to start forming a description of how individuals conceptualize benefits from risk management medicines. SEARCH STRATEGY AND SYNTHESIS: We reviewed the literature on patients' expectations with a focus on the influences on expectations regarding medicines prescribed for long-term conditions. Searches in Medline and Scopus identified 20 studies for inclusion, describing qualitative aspects of beliefs, views, thoughts and expectations regarding medicines. RESULTS: A qualitative synthesis using a constant comparative thematic analysis identified four themes describing influences on expectations: a need to achieve a specific outcome; the development of experiences and evaluation over time; negative values such as dependency and social stigma; and personalized meaning of the necessity and usefulness of medicines. CONCLUSIONS: The findings in this synthesis resonate with previous research into expectations of medicines for prevention and treatment of different conditions. However, a gap in the knowledge regarding patients' conceptualization of future benefits with medicines is identified. The study highlights suggestions for further empirical work to develop a deeper understanding of the role of patients' expectations in prescribing for long-term risk management.

Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials.

BACKGROUND: A 2003 survey suggested the number of noncommercial trials in the UK was declining. Formation of the NIHR in 2006 and increased research spending by the Department of Health may have increased the number of noncommercial trials but no data are available. METHODS: Available data on UK noncommercial trials (were obtained from the two relevant registries: ISRCTN register for the UK, and US ClinicalTrials.gov. Data on each trial were sorted by start year, and compared with the: 2003 survey, and UKCRN portfolio database from 2007. RESULTS: The number of UK noncommercial trials registered rose from 25 in 1990 to 188 in 1999, peaked at 533 in 2003, and fell back to 334 in 2009. Total trials registered was similar to but slightly above those in the 2003 survey up to 1998, then rose sharply to 2002 before falling to 2007. From 2007 to 2009 the number registered to start each year was similar to but slightly above the UKCRN database. Less than 10% of UK noncommercial trials registered with ClinGov for most years before 2005, but this rose to 35% by 2009. CONCLUSIONS: For the periods of overlap, trial registration data provide fairly similar totals to other sources on the number of noncommercial trials starting each year. The rise and fall in the number of trials registered between 1999 and 2007 was due to those registered in the ISRCTN database as funded by NHS Trusts. After 2007, the number of trials registered as funded by NHS Trusts has fallen in the ISRCTN register but these trials may have migrated to the US ClinGov register. The total number of noncommercial trial starts, excluding those funded by NHS Trusts, has been upward since around 2002. By 2009 the two main funders were NIHR and charities. Feasibility of using registration data to monitor the number of noncommercial trials has been demonstrated but is complicated by the use of two registers and difficulties in accessing the data. We recommend an annual report on the number of noncommercial trials registering each year.

Translating comparative effectiveness research into clinical practice: the UK experience.

Comparative effectiveness research (CER) is not new but its potential to improve the effectiveness of healthcare has not yet been exploited in the US. Other countries such as the UK have more experience of this. Key points of the UK experience are summarized here and some possible pointers for the US are drawn. These include the following: how to go beyond the evidence and apply judgements to make recommendations with authority and in a timely manner; how to implement these recommendations; how to identify suitable topics; and how to be open and transparently fair to all stakeholders. The quality of the science of CER is key but this needs developing, and not just in biomedical or statistical terms but also in how to understand public expectations, and how to implement its recommendations. A key issue is the role of health economics, which seems to have been marginalized by the CER legislation, but perhaps this is more apparent than real. Clearly this is a matter for much further debate. It is hard to see how CER can deliver its potential without active consideration of both benefits and costs. Although other countries have more experience of this than does the US, the context for such work is always very specific and the US will have to find its own way, while trying to avoid some of the errors made elsewhere.

A randomised controlled trial of extended brief intervention for alcohol dependent patients in an acute hospital setting (ADPAC).

BACKGROUND: Alcohol dependence affects approximately 3% of the English population, and accounts for significant medical and psychiatric morbidity. Only 5.6% of alcohol-dependent individuals ever access specialist treatment and only a small percentage ever seek treatment. As people who are alcohol dependent are more likely to have experienced health problems leading to frequent attendance at acute hospitals it would seem both sensible and practical to ensure that this setting is utilised as a major access point for treatment, and to test the effectiveness of these treatments. METHODS/DESIGN: This is a randomised controlled trial with a primary hypothesis that extended brief interventions (EBI) delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be effective when compared to usual care in reducing overall alcohol consumption and improving on the standard measures of alcohol dependence. Consecutive patients will be screened for alcohol misuse in the Emergency Department (ED) of a district general hospital. On identification of an alcohol-related problem, following informed written consent, we aim to randomize 130 patients per group. The ASN will discharge to usual clinical care all control group patients, and plan a programme of EBI for treatment group patients. Follow-up interview will be undertaken by a researcher blinded to the intervention at 12 and 24 weeks. The primary outcome measure is level of alcohol dependence as determined by the Severity of Alcohol Dependence Questionnaire (SADQ) score. Secondary outcome measures include; Alcohol Use Disorders Identification Test (AUDIT) score, quantity and frequency of alcohol consumption, health-related quality of life measures, service utilisation, and patient experience. The trial will also allow an assessment of the cost-effectiveness of EBI in an acute hospital setting. In addition, patient experience will be assessed using qualitative methods. DISCUSSION: This paper presents a protocol for a RCT of EBI delivered to alcohol dependent patients by an ASN within an ED. Importantly; the trial will also seek to understand patients' perceptions and experiences of being part of a RCT and of receiving this form of intervention. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN78062794.

Using comparative effectiveness research to inform policy and practice in the UK HHS: past, present and future.

Health systems that have fixed budgets and a coherent organizational structure generally have found it valuable to have a dedicated primary research capacity to answer decision-oriented value-for-money questions of particular importance to the system. The UK NHS is one example of such a system. Here, we review the historical evolution of building comparative effectiveness research (CER) capacity in the NHS, describe the current situation, with a focus on how this research is used to inform decisions, and discuss present and emerging challenges. We draw some possible lessons for the US, which is currently considering using CER to inform healthcare policy and practice decisions.

Drugs, money and society (Part II).

Pharmacoeconomics started as marketing but has developed into a valuable tool in the fuller assessment of drug therapies. Its principles are now widely accepted, and many countries have government-funded agencies with responsibility for its application, most notably the National Institute for Health and Clinical Excellence in England. Many clinical pharmacologists are active in this area, and the discipline itself is part of the clinical pharmacology trainees' curriculum. Further developments will include value-based pricing and its use in cost sharing arrangements between health service and manufacturers.

The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: a systematic review.

OBJECTIVES: To assess the clinical effectiveness of central venous catheters (CVCs) treated with anti-infective agents (AI-CVCs) in preventing catheter-related bloodstream infections (CRBSI). DATA SOURCES: MEDLINE (OVID), EMBASE, SCI//Web of Science, SCI/ISI Proceedings, and the Cochrane Library. STUDY SELECTION: A systematic review of the literature was conducted using internationally recognized methodology. All included articles were reports of randomized controlled trials comparing the clinical effectiveness of CVCs treated with AI-CVCs with either standard CVCs or another anti-infective treated catheter. Articles requiring in-house preparation of catheters or that only reported interim data were excluded. DATA EXTRACTION: Data extraction was carried out independently and crosschecked by two reviewers using a pretested data extraction form. DATA SYNTHESIS: Meta-analyses were conducted to assess the effectiveness of AI-CVCs in preventing CRBSI, compared with standard CVCs. Results are presented in forest plots with 95% confidence intervals. RESULTS: Thirty-eight randomized controlled trials met the inclusion criteria. Methodologic quality was generally poor. Meta-analyses of data from 27 trials assessing CRBSI showed a strong treatment effect in favor of AI-CVCs (odds ratio 0.49 (95% confidence interval 0.37-0.64) fixed effects, test for heterogeneity, chi-square = 28.78, df = 26, p = 0.321, I = 9.7). Results subgrouped by the different types of anti-infective treatments generally demonstrated treatment effects favoring the treated catheters. Sensitivity analyses investigating the effects of methodologic differences showed no differences to the overall conclusions of the primary analysis. CONCLUSION: AI-CVCs appear to be effective in reducing CRBSI compared with standard CVCs. However, it is important to establish whether this effect remains in settings where infection-prevention bundles of care are established as routine practice. This review does not address this question and further research is required.

Evidence-informed evidence-making.

The extent to which clinical and public health guidance developed by the National Institute for Health and Clinical Excellence (NICE) can effectively serve the public by improving quality and efficiency across the National Health Service (NHS) and the broader public sector depends largely on the quality and relevance of the available evidence which informs its decisions. There are well-established organizational and procedural links between NICE and academic and professional organizations that undertake evidence synthesis. However, there are fewer means for evidence gaps identified during the development of NICE guidance to lead to the commissioning of new prospective studies. In this paper, we discuss the importance of a publicly funded clinical and public health research agenda that includes new prospective studies aimed at addressing knowledge gaps identified by NICE. We describe the early experience of NICE and the National Institute for Health Research (NIHR) working together to articulate and commission research to inform best practice recommendations. We propose ways in which NICE can collaborate more effectively with research funders to improve the evidence base upon which it bases its recommendations.