Disruptive technologies in health care disenchanted: a systematic review of concepts and examples.

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

Effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2, to inform COVID-19 diagnosis: a rapid systematic review.

OBJECTIVES: We undertook a rapid systematic review with the aim of identifying evidence that could be used to answer the following research questions: (1) What is the clinical effectiveness of tests that detect the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to inform COVID-19 diagnosis? (2) What is the clinical effectiveness of tests that detect the presence of antibodies to the SARS-CoV-2 virus to inform COVID-19 diagnosis? DESIGN AND SETTING: Systematic review and meta-analysis of studies of diagnostic test accuracy. We systematically searched for all published evidence on the effectiveness of tests for the presence of SARS-CoV-2 virus, or antibodies to SARS-CoV-2, up to 4 May 2020, and assessed relevant studies for risks of bias using the QUADAS-2 framework. MAIN OUTCOME MEASURES: Measures of diagnostic accuracy (sensitivity, specificity, positive/negative predictive value) were the main outcomes of interest. We also included studies that reported influence of testing on subsequent patient management, and that reported virus/antibody detection rates where these facilitated comparisons of testing in different settings, different populations or using different sampling methods. RESULTS: 38 studies on SARS-CoV-2 virus testing and 25 studies on SARS-CoV-2 antibody testing were identified. We identified high or unclear risks of bias in the majority of studies, most commonly as a result of unclear methods of patient selection and test conduct, or because of the use of a reference standard that may not definitively diagnose COVID-19. The majority were in hospital settings, in patients with confirmed or suspected COVID-19 infection. Pooled analysis of 16 studies (3818 patients) estimated a sensitivity of 87.8% (95% CI 81.5% to 92.2%) for an initial reverse-transcriptase PCR test. For antibody tests, 10 studies reported diagnostic accuracy outcomes: sensitivity ranged from 18.4% to 96.1% and specificity 88.9% to 100%. However, the lack of a true reference standard for SARS-CoV-2 diagnosis makes it challenging to assess the true diagnostic accuracy of these tests. Eighteen studies reporting different sampling methods suggest that for virus tests, the type of sample obtained/type of tissue sampled could influence test accuracy. Finally, we searched for, but did not identify, any evidence on how any test influences subsequent patient management. CONCLUSIONS: Evidence is rapidly emerging on the effectiveness of tests for COVID-19 diagnosis and management, but important uncertainties about their effectiveness and most appropriate application remain. Estimates of diagnostic accuracy should be interpreted bearing in mind the absence of a definitive reference standard to diagnose or rule out COVID-19 infection. More evidence is needed about the effectiveness of testing outside of hospital settings and in mild or asymptomatic cases. Implementation of public health strategies centred on COVID-19 testing provides opportunities to explore these important areas of research.

A scoping review of patient and public perspectives on cell and gene therapies.

Aim: The development and introduction of cell and gene therapies presents complex social and economic issues. Fully addressing these challenges requires engagement with patients and the public. Materials & methods: A systematically conducted scoping review was undertaken to gauge current patient and public knowledge and perspectives, and as such inform requirements for future research, education and engagement activities. Results: A heterogeneous collection of 35 studies were identified. Levels of knowledge among patients and the public were extremely variable. Studies indicated general acceptance of therapies. Conclusion: The review identified the need for tailored educational activities, and in particular the importance of addressing misconceptions. There is also a need for robust qualitative research considering perspectives on current and forthcoming licensed therapies.

Patient and public perspectives on cell and gene therapies: a systematic review.

Cell and gene therapies offer opportunities for treating disease with potential to restore function, and cure disease. However, they are not without risk and pose complex logistical, economic, ethical and social challenges for health systems. Here we report our systematic review of the current evidence on patient and public knowledge and perspectives of cell and gene therapies, to inform future research, education and awareness raising activities. We screened 10,735 titles and abstracts, and evaluated the full texts of 151 publications. The final selection was 35 publications. Four themes were generated from the narrative synthesis of the study findings namely: (1) Knowledge and understanding of cell and gene therapies, (2) Acceptance of cell and gene therapies (3) Understanding of risk and benefits of therapy, and (4) Information needs and current sources of information. As potential funders or future recipients, it is important that the public and patients are aware of these therapies, understand the issues involved, and can contribute to the debate. This review highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies. High quality studies exploring patient and public opinions and experiences of cell and gene therapy are required. Patient and public perceptions of these therapies, alongside evidence of clinical and cost-effectiveness, will be central to their uptake and use.

INFLUENCE OF HEALTH TECHNOLOGY ASSESSMENT AND ITS MEASUREMENT.

OBJECTIVES: The aim of this study was to obtain information on methods used to measure health technology assessment (HTA) influence, decisions that were influenced, and outcomes linked to HTA. METHODS: Electronic databases were used to locate studies in which HTA influence had been demonstrated. Inclusion criteria were studies that reliably reported consideration by decision makers of HTA findings; comparative studies of technology use before and after HTA; and details of changes in policy, health outcomes, or research that could be credibly linked to an HTA. RESULTS: Fifty-one studies were selected for review. Settings were national (24), regional (12), both national and regional (3) hospitals (9), and multinational (3). The most common approach to appraisal of influence was review of policy or administrative decisions following HTA recommendations (51 percent). Eighteen studies (35 percent) reported interview or survey findings, thirteen (26 percent) reviewed administrative data, and six considered the influence of primary studies. Of 142 decisions informed by HTA, the most common types were on routine clinical practice (67 percent of studies), coverage (63 percent), and program operation (37 percent). The most frequent indications of HTA influence were on decisions related to resource allocation (59 percent), change in practice pattern (31 percent), and incorporation of HTA details in reference material (18 percent). Few publications assessed the contribution of HTA to changing patient outcomes. CONCLUSIONS: The literature on HTA influence remains limited, with little on longer term effects on practice and outcomes. The reviewed publications indicated how HTA is being used in different settings and approaches to measuring its influence that might be more widely applied, such as surveys and monitoring administrative data.

Involvement of consumers in health technology assessment activities by Inahta agencies.

OBJECTIVES: To obtain further information from members of the International Network of Agencies for Health Technology Assessment (INAHTA) on the involvement of consumers in their programs. METHODS: A questionnaire for a survey was developed and sent to member agencies in November 2010. Survey responses were compared with those from an earlier survey conducted in 2005. RESULTS: Of the thirty-three agencies that provided responses, 67 percent involve consumers in some aspects of their health technology assessment (HTA) programs, compared with 57 percent in 2005. As in the earlier survey, most agencies reporting involvement have contact with consumer or patient organizations and a large minority also involve individual consumers. Summaries of HTA reports that are intended to be easily understood by consumers are prepared by 84 percent of the agencies, and 42 percent involve consumers in dissemination of HTA material. In both areas, there was some increase from the levels previously reported. CONCLUSIONS: The survey results suggest that there is a trend to increased involvement of consumers by the INAHTA agencies in their programs but that the level of involvement remains relatively limited. The manner of consumer participation varies between agencies.

Abolition of prescription charges in Wales: the impact on medicines use in those who used to pay.

OBJECTIVES: patient co-payments for prescription medicines in Wales were abolished in April 2007 and there has been much speculation on the possible effects. We analysed patient-reported use of medicines before and after abolition of the prescription charge, noting changes in the number of items prescribed, number of non-prescription medicines purchased and participants not collecting all prescribed items (primary non-adherence). METHODS: a sample of community pharmacists across Wales (n = 249) issued questionnaires to customers at the point of dispensing who were not exempt from the prescription charge. A second questionnaire was delivered by post to those who returned the first questionnaire (n = 1027) and expressed a willingness to participate further. Paired t-tests were applied to responses from those completing both questionnaires (n = 593). Further analyses were carried out according to gender, age and reported levels of household income. KEY FINDINGS: there was a statistically significant (P = 0.03) rise in the number of items prescribed, and a statistically significant fall (P = 0.02) in the number of non-prescription medicines purchased. Primary non-adherence was also found to fall between pre- and post-abolition periods. Those most affected in terms of increase in number of prescribed items prescribed were the older age group (45-59 years), and those with household income of between £15600 and £36400. The most affected in the fall in number of medicines purchased were males, those in the lower age group (25-34 years) and those with a higher household income (>£36400). CONCLUSIONS: although the rise in number of items prescribed and fall in number of medicines purchased was generally anticipated, there appeared to be little or no effect for those on the lowest incomes.

Abolition of prescription copayments in Wales: an observational study on dispensing rates.

OBJECTIVE: To assess effects of abolition of prescription copayments in Wales on rates of dispensing. METHODS: General practice-level monthly dispensing data were compared before/after abolition between Wales and North East (NE) England where the charge was retained. Data for 14 medicines that had most items dispensed subject to charge before abolition were similarly compared with NE England. For those with over-the-counter substitutes, wholesale sales to pharmacies were examined. A survey examined local initiatives, which might differentially affect dispensing between the two areas. RESULTS: Total dispensing rates (items/1000 patients) increased significantly in both areas but significantly less so in Wales (difference = -19.7, P = 0.024, 95% confidence interval [CI] = -36.7 to -2.6). For the 14 selected medicines, combined dispensing rates increased significantly in both areas but significantly more in Wales (difference = 27.51, P < 0.0001, 95% CI = 23.66-31.35). There was much variation for individual drugs, but categories tended to show this same trend except for antibiotics, where rates increased in Wales but decreased in NE England. The survey revealed few local initiatives that could explain these differences. Sales of over-the-counter substitutes did not explain the changes in dispensing. CONCLUSIONS: The Welsh policy was associated with a modest increase in dispensing rates relative to NE England for the 14 medicines with the highest number of items dispensed subject to charge before abolition. Although factors besides the copayment may have influenced these observations, the smaller relative increase in total dispensing rates in Wales suggests that the overall impact of abolition was minimal.

Variant Creutzfeldt-Jakob disease: costs borne by families.

The objectives of this study were: (1) to estimate the costs borne by families caring for patients with variant Creutzfeldt-Jakob disease (vCJD); (2) to contextualise results to recent policy initiatives, and (3) to consider the methodological problems of estimating costs of care. Semi-structured interviews and a follow-up postal questionnaire, eliciting costs to families both before and after the patient's death, were carried out. Participants included 19 families of patients with vCJD. Cost profiles were constructed, detailing key time and financial costs associated with their relative's illness and death accruing to families. Main outcome measures included total, median and ranges of relevant cost elements. Sensitivity analyses, comparing high and low cost estimates, were undertaken. The total time cost to families before patient's death ranged between 605 and 9230 hours (median 2006 hours). Applying low cost estimates, families incurred between pound 2616 and pound 39 588 (median pound 14 481) in forgone earnings and between pound 2699 and pound 18 558 (median pound 8049) in marginal sundry costs before the patient's death. The value of care provided by families ranged between pound 0 and pound 87 303 (median pound 9652) at low cost estimates. Many families continued to incur costs after the patient's death, with low cost estimates per week ranging between pound 0 and pound 176 (median pound 29). Costs to families associated with vCJD were substantial and greatly exceeded benefit entitlements. These costs were high even if patients received care in hospital, varied as the illness progressed and continued after patients' deaths. The National Carers Strategy does not consider fully the needs of some groups of carers or the full range or magnitude of potential costs to families associated with caring.

Moving home: costs associated with different models of accommodation for adults with learning disabilities.

This paper reports on variation in the cost and social outcomes of provision for clients with learning disabilities, resettled across different models of community accommodation; identifying personal and service-related characteristics influential on such variation. The study was conducted to inform the community reprovisioning strategy associated with the phased closure of the Gogarburn and Tornaveen learning disability hospitals in the Lothian region, Scotland. Total mean service costs, quality of life and community integration outcome data were collected and compared. Total mean service costs ranged between pound16 438 and pound74 097 per year (mean pound42 023; SD = pound16 712). Cost estimates varied by age and dependency group, with costs for elderly clients comparatively low. Overall, there was an inverse relationship between total mean costs and size of accommodation. There was no evidence of a direct relationship between costs and changes in social outcomes. Services with the lowest mean costs were, however, associated with the smallest increases in social outcomes. The most expensive services did not realise proportionally greater gains in social outcomes. The paper concludes that clients generally benefited from the transition from hospital to community accommodation. However, some experienced better outcomes than others. In the absence of a clear link between levels and type of resource use and social outcomes, it is difficult to identify which service features are more or less efficacious in achieving positive outcomes. Broader evaluation perspectives, embracing a fuller range of costs and benefits, will be required to unpack exactly what it is about different models of community care provision that leads to positive outcomes, or otherwise, for learning disability clients. A more sound evidence base is required before effective strategies can be designed to ensure that key policy outcomes are realised and social integration truly achieved.

Total purchasing, community and continuing care: lessons for future policy developments in the NHS.

The introduction of total purchasing pilots (TPPs) into the National Health Service (NHS) gave general practitioners (GPs) significant new opportunities to take responsibility for the development of community and continuing care (CCC) services. Based on five case studies of TPPs involved in developing CCC this paper asks three questions: (1) to what extent were the TPP's involvement in CCC informed by an awareness of CCC policy?; (2) were TPPs involved in joint commissioning to develop integrated purchasing or provision which was informed by population based needs assessment?; (3) were TPPs seeking to involve users, carers and voluntary agencies in their plans? The findings indicate that TPPs showed little awareness of national or local policy for CCC, although their project initiatives did address some of the policy issues (in particular a recognition of the need for joint working at the practice level). At the time of fieldwork, four of the case study TPPs had begun to investigate the potential for integrated purchasing, and three of them had relatively sophisticated models of both horizontally and vertically integrated provision of care. However, the TPPs developments were not based on systematic population based needs assessment. The paper concludes that there is potential for the primary care led groups proposed in the recent white papers in England, Scotland and Wales to improve integration of care both horizontally and vertically. However, they may need policy guidance and push to: encourage them to put CCC high on their agenda for action; to work with people with expertise in population based, prevention focused, needs assessment; and to find innovative ways to include users, carers and voluntary agencies. Incentives or levers (such as control over budgets) may be needed to promote joint working between staff in different agencies.