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 .

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.

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.

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.

Perceptions of the impact of primary care organizations on GP prescribing: the iron fist in the velvet glove?

PURPOSE: This qualitative study aims to examine key stakeholders' perspectives of primary care group/trust prescribing strategies. Within the context of general practice prescribing, the paper also debates the wider issue of whether GPs' prescribing autonomy is under threat from managerial expansion following recent organisational changes in primary care. DESIGN/METHODOLOGY/APPROACH: Data were obtained from focus groups and a series of individual semi-structured interviews with GPs and key primary care organisation stakeholders. FINDINGS: The data underlie a tension between the managerial objective of cost-restraint and GPs' commitment to quality improvement and individual clinical patient management. In presenting both managerial and medical narratives, two divergent and often conflicting discourses emerge, which leads to speculation that managerial attempts to constrain prescribing autonomy will achieve only limited success. The contention is that GPs' discourse features as a challenge to a managerial discourse that reflects attempts to regulate, standardise and curtail clinical discretion. This is due not only to GPs' expressed hegemonic ideals that clinical practice centres on the interests of the individual patient, but also to the fact that the managerial discourse of evidence-based medicine encapsulates only a limited share of the knowledge that GPs draw on in decision making. However, while managers' discourse presented them as unwilling to impose change or directly challenge clinical practice, evidence also emerged to suggest that is not yet possible to be sufficiently convinced of the future retention of prescribing autonomy. On the other hand, the use of peer scrutiny posed an indirect managerial influence on prescribing, whilst the emergence of prescribing advisors as analysts of cost-effectiveness may threaten doctors' dominance of medical knowledge. RESEARCH LIMITATIONS/IMPLICATIONS: There is a continuing need to analyse the impact of the new managerial reforms on primary care prescribing. ORIGINALITY/VALUE: This study provides a snapshot of managerial and GP relations at a time of primary care transition.

New drug prescribing by hospital doctors: the nature and meaning of knowledge.

In the UK the high cost of new drugs is partly accountable for the growth in spending on prescription drugs. Most prescribing takes place in general practice and the influence of secondary care prescribing on primary care prescribing is well recognized; yet the factors that influence hospital prescribing have been little researched. Drawing on accounts of actual prescribing events from hospital doctors from a range of specialties, we investigated the processes by which new drugs come into practice, from hospital doctors' awareness of new drugs to the assimilation and interpretation of evidential sources. The determinants of new drug prescribing were interconnected within four forms of knowledge: scientific knowledge, social knowledge, patient knowledge and experiential knowledge. Furthermore, the nature of knowledge could only be understood within its situated context. The revelation of multiple and contingent forms of knowledge highlights the problematic nature of knowledge construction within the approaches of evidence-based medicine.

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.

A qualitative study of GPs' and PCO stakeholders' views on the importance and influence of cost on prescribing.

With prescribing expenditure rising and evidence of prescribing costs variation, general practitioners (GPs) in the UK are under increasing pressure to contain spending. The introduction of cash-limited, unified budgets and increased monitoring of prescribing within Primary Care Organizations (PCO) are intended to increase efficiency and enhance GPs financial responsibility. Whilst GPs regularly receive data on the costs of their prescribing and also performance against a set prescribing budget, little is known about the extent to which GPs take cost into account in their prescribing decisions. This study undertook a qualitative exploration of the attitudes of various stakeholders on the relative importance and influence of cost on general practice prescribing. In order to explore a plurality of perspectives, data were obtained from focus groups and a series of individual semi-structured interviews with GPs and key PCO stakeholders. The data suggest that although almost all GPs believed costs should be taken into account when prescribing, there was great variation in the extent to which this was applied and to how sensitive GPs were to costs. Cost was secondary to clinical effectiveness and safety, whilst individual patient need was emphasized above other forms of rationality or notions of opportunity costs. Conflict was apparent between a PCO policy of cost-containment and GPs' resistance to cost-cutting. GPs largely applied simple cost-minimization while cost-consideration was undermined by contextual factors. Implications for research and policy are discussed.

Neuropsychotherapeutics in the UK: what has been the impact of NICE on prescribing?

The UK National Institute for Clinical Excellence (NICE) was set up in 1999 to advise the National Health Service (NHS) on the use of new technologies largely, but not exclusively, on the basis of their clinical and cost effectiveness. There have been problems with this, as with any developing system, most of which have arisen from issues not directly under the control of NICE. Despite this, NICE has already achieved a pivotal role in determining the uptake of new therapies into the NHS. In the area of neuropsychiatric therapies, NICE has examined a number of topics and has generally facilitated the increased use of the agents examined, approving the use, within limitations, of such drugs as riluzole, atypical antipsychotics and cholinesterase inhibitors. Although the use of some of these therapies had been growing, it had previously been restricted by funding in the NHS. As a result of NICE guidance, these funding restrictions have generally been lifted. NICE has rejected one area of neurological therapy so far--that of interferon-beta products and glatiramer acetate for multiple sclerosis--on the grounds of clinical uncertainty about long-term benefits and poor cost effectiveness. However, the UK Government has created a novel risk-sharing scheme in collaboration with the sponsoring companies to make these drugs available at a level of cost effectiveness acceptable to the NHS. The feasibility of this scheme is as yet unclear. This might be seen as either a triumph for NICE or as an undermining of it for political ends. One interesting aspect that is more prominent in neuropsychiatric disorders than in other areas of NICE activity has been the power of patient advocacy in encouraging acceptance of therapies where the evidence base was weak or the incremental cost-effectiveness ratio was unfavourable. The principles behind the activities of NICE attract wide support within the NHS, but the details of its decisions have often not been popular within NHS management who have to deliver them. Some of this relates more to the context and political environment within which NICE operates than to a failing within NICE itself. NICE will continue to become increasingly important in determining the use of new drugs within the UK NHS.

Lifestyle medicines and the elderly.

Lifestyle medicines are those used to meet patient aspirations rather than traditionally defined medical need. However, in many cases, the boundary between the two is ill defined and a matter of degree or cultural expectation. Such medicines are not yet widely used by the elderly, but this may change in an increasingly consumerist society. There are ethical, clinical and financial issues to be considered around these drugs, which are not independent. The ethical issues relate mainly to the rising consumerism in medicine, and whether these and other medicines are consumer goods available almost on demand. The clinical issues concern the balancing of risk and benefit for these medicines, and how we inform patients of these issues. The financial issues are who should pay and whether third party payers can and should ration these medicines and, if so, how. Lifestyle medicines may provoke a debate on the whole issue of rationing. These issues are not confined to the use of these medicines by the elderly and their resolution will depend on a broader societal debate, in which the elderly need to be active.

Understanding why GPs see pharmaceutical representatives: a qualitative interview study.

BACKGROUND: Doctors are aware of the commercial bias in pharmaceutical representative information; nevertheless, such information is known to change doctors' prescribing, and augment irrational prescribing and prescribing costs. AIM: To explore GPs, reasons for receiving visits from pharmaceutical representatives. DESIGN OF STUDY: Qualitative study with semi-structured interviews. SETTING: One hundred and seven general practitioners (GPs) in practices from two health authorities in the North West of England. RESULTS: The main outcome measures of the study were: reasons for receiving/not receiving representative visits; advantages/disadvantages in receiving visits; and quality of representative-supplied information. Most GPs routinely see pharmaceutical representatives, because they bring new drug information speedily; they are convenient and accessible; and can be consulted with a saving of time and effort. Many GPs asserted they had the skills to critically appraise the evidence. Furthermore, the credibility and social characteristics of the representative were instrumental in shaping GPs' perceptions of representatives as legitimate information providers. GPs also received visits from representatives for reasons other than information acquisition. These reasons are congruent with personal selling techniques used in marketing communications. CONCLUSIONS: The study draws attention to the social and cultural contexts of GP-representative encounters and the way in which the acquisition of pharmacological information within the mercantile context of representative visits is legitimated. This highlights the need for doctors to critically appraise information supplied by representatives in relation to other information sources.

Measuring consultation skills in primary care in England: evaluation and development of content of the MAAS scale.

BACKGROUND: Consultation skills are essential for general practice. Tools for measuring consultation skills in everyday practice are not well developed AIM: To examine and develop the content validity of the MAAS History-taking and Advice Checklist GP (MAAS-GP) tool which is used in The Netherlands for testing consultation skills, with simulated patients in United Kingdom general practice from the perspectives of both general practitioners and patients. DESIGN OF STUDY: Qualitative research using semi-structured interviews. SETTING: Alternate patients attending seven general practices in the north west of England. METHOD: Thematic analysis of the contents of patient and GP interviews, and of focus groups, mapping key themes to the MAAS-GP. RESULTS: There was strong agreement between patients and GPs on issues mapping to 46 out of 68 items of the MAAS-GP. Eight further MAAS-GP items were linked to issues only raised by patients and four to issues raised only by GPs. The remaining 10 items could not be related to issues raised by either. All of the issues raised by GPs could be mapped but 27 patient items could not. These were included in a revised checklist, the Liverpool MAAS (LIV-MAAS). CONCLUSION: the revised tool seems to have content validity in measuring consultation skills. Measurement of its relability is now required.