scholarly journals How has implementation been incorporated in health technology assessments in the United Kingdom? A systematic rapid review

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Robert Heggie ◽  
Kathleen Boyd ◽  
Olivia Wu

Abstract Objectives Health interventions in a clinical setting may be complex. This is particularly true of clinical interventions which require systems reorganization or behavioural change, and/or when implementation involves additional challenges not captured within a clinical trial setting. Medical Research Council guidance on complex interventions highlights the need to consider economic evaluation alongside implementation. However, the extent to which this guidance has been adhered to, and how, is unclear. The failure to incorporate implementation within the evaluation of an intervention may hinder the translation of research findings into routine practice. This will have consequences for patient care. This study examined the methods used to address implementation within health research conducted through funding from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. Methods We conducted a rapid review using a systematic approach. We included all NIHR HTA monographs which contained the word “implementation” within the title or abstract published between 2014 and 2020. We assessed the studies according to existing recommendations for specifying and reporting implementation approaches in research. Additional themes which were not included in the recommendation, but were of particular relevance to our research question, were also identified and summarized in a narrative synthesis. Results The extent to which implementation was formally incorporated, and defined, varied among studies. Methods for examining implementation ranged from single stakeholder engagement events to the more comprehensive process evaluation. There was no obvious pattern as to whether approaches to implementation had evolved over recent years. Approximately 50% (22/42) of studies included an economic evaluation. Of these, two studies included the use of qualitative data obtained within the study to quantitatively inform aspects relating to implementation and economic evaluation in their study. Discussion A variety of approaches were identified for incorporating implementation within an HTA. However, they did not go far enough in terms of incorporating implementation into the actual design and evaluation. To ensure the implementation of clinically effective and cost-effective interventions, we propose that further guidance on how to incorporate implementation within complex interventions is required. Incorporating implementation into economic evaluation provides a step in this direction.

2018 ◽  
Vol 34 (S1) ◽  
pp. 122-123
Author(s):  
Ann Scott ◽  
Carmen Moga ◽  
Christa Harstall

Introduction:Clinical practice guidelines (CPGs) are a key vehicle for converting evidence into action. CPGs can be produced by various methods: de novo, adaptation, adoption, or a combination of these. Deciding whether and how to develop a guideline can be challenging. Health technology assessment (HTA) researchers from the Institute of Health Economics developed a multi-step decisional algorithm highlighting the decision nodes in the initial phase of guideline development where HTA products and expertise can be valuable in demystifying these decisions.Methods:A literature search was conducted for articles comparing methods of developing CPGs, with particular focus on finding a priori criteria for deciding when to use one method versus another.Results:The published literature is sparse and there are no specific criteria available for deciding when to use one method of development versus another. The proposed multi-step algorithm identifies similar steps in the production of all types of CPGs: the set-up phase; establishing the need for a new CPG in consultation with a guideline development group and local stakeholders; developing research question(s); conducting searches for suitable existing guidelines; and finalizing the guideline. HTA can help set the health question(s) and identify and screen existing CPGs. When CPGs are not available, HTA methods are implemented to update the evidence in a blend of de novo and adaptation processes by reviewing umbrella reviews, systematic reviews, and primary studies. Quality appraisal of existing guidelines and syntheses of evidence in a rapid review fashion help determine whether there are enough studies to support the guideline scope.Conclusions:Deciding which method of guideline development to employ requires ample methodological expertise, an intimate knowledge of the clinical practice environment, and access to detailed contextual information. The proposed multi-step algorithm shows how to successfully leverage HTA resources to support CPG production and move research evidence into practice.


Author(s):  
Nidhi Gupta ◽  
Gaurav Jyani ◽  
Kavitha Rajsekar ◽  
Rakesh Gupta ◽  
Anu Nagar ◽  
...  

AbstractA health system is considered efficient when it provides maximum health gains to the population from the available resources. Newer drugs, diagnostics and treatment strategies aim to improve the health of the population, however, they come at an increased cost. Therefore, for an efficient health system, it needs to be decided if the extra cost being incurred is justified to achieve the extra health gains. In this regard, health technology assessment (HTA) helps to make evidence informed decisions by evaluating relative cost and benefits of the available interventions. Economic evidence generated by HTA can also be used in framing standard treatment guidelines (STGs) for high-cost cancer care. In multi-payer systems like India, the decisions regarding the clinical management of patients are taken based on the patients' ability to pay, which creates inequities in utilization of healthcare. Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (AB PM-JAY) offers an opportunity to ensure equity as it reduces financial barriers, besides having a potential to affect efficiency by including only cost-effective interventions in the benefit package. As a result, informed clinical decisions based upon HTA evidence can make cancer treatment more efficient, equitable and affordable for the patients.


2019 ◽  
Vol 35 (S1) ◽  
pp. 15-15
Author(s):  
Mareike Mähs

IntroductionSmart medical devices can empower elderly to live independently in their familiar surroundings. To enhance their dissemination, they have to be shown to be cost-effective. Economic studies evaluating such technologies are missing or are criticized for their low quality. There are several challenges in the evaluation of smart medical devices, including their complex nature and innovative character. The question arises: how can evaluations elicit the benefits and cost-effectiveness of smart medical devices. This research has the aim of outlining challenges and demands on the evaluation of smart medical devices.MethodsThe embedding of the technology in existing structures can influence the effectiveness of the technology. By comparing such a technology with a regular intervention, learning effects have to be considered. Regular modifications and further developments of these technologies can complicate the traceability of the effects. Complex cause-effect relationships with possible interactions arise that are difficult to quantify and express in standardized endpoints, utilities or monetary values. Demands on the evaluation of smart medical devices have been explored with literature reviews and scenario techniques using the example of intelligent rollators.ResultsIt is important to apply mixed-method approaches not only in the clinical but also practical setting and conduct observational as well as qualitative studies. Potential users, their relatives and care personnel should be involved in the evaluation of intelligent rollators and attention should be payed to subjects with disabilities. Prospective studies should be conducted at different stages along the lifecycle of the technology. A conceptual model should be developed and evaluated as well as adapted on a regular basis.ConclusionsThe research shows the need to adapt common methods used in economic evaluation to the characteristics of smart medical devices. As a next step, a framework for the economic evaluation of such technologies within the scope of Health Technology Assessment is developed based on these demands.


2019 ◽  
Vol 35 (S1) ◽  
pp. 78-78
Author(s):  
Victoria Hurtado-Meneses ◽  
Catherine De la Puente ◽  
Marianela Castillo ◽  
Sergio Poblete

IntroductionAny technology submission for the high-cost treatment fund in Chile requires an economic evaluation; however, this is time consuming and given its high number, it is not possible to inform decisions within the established period of time. This presentation proposes a guide for the transferability of international economic evaluation results to our national context, with the intention to inform decision makers in a brief period of time.MethodsA literature review on transferability analysis, tools and instruments to perform transferability analysis and on how to assess quality of economic evaluations was conducted. In addition, a workshop was held to discuss the proposal with other relevant researchers, in order to receive feedback.ResultsThe proposed instrument is based on Welte and consists of: (i) a research question is formulated and a systematic review of economic evaluations is conducted, (ii) the three Welte knock-out criteria are applied to these results and, if these are met, the articles pass to the next stage, (iii) a scored comparison based on twelve criteria is conducted on the articles and each article is compared against the Chilean (economic) reference case, (iv) high-scored economic evaluations will be grouped according of their incremental cost-effectiveness ratio (ICER). If all ICERs do not converge, to the same conclusion, the intervention would not be transferable. If the ICERs of these studies converge, then the results will be compared against the national threshold. If the ICERs are greater than the threshold, the intervention would not be cost-effective. If the ICERs are lower than the threshold, then the intervention would be cost-effective in Chile.ConclusionsDespite a de novo analysis still being the gold standard to inform decision makers, the proposed instrument could be used as an alternative, given the short time limit and the scarcity of qualified human resources.


2013 ◽  
Vol 22 (4) ◽  
pp. 313-320 ◽  
Author(s):  
V. C. Leeson ◽  
P. Tyrer

Purpose.To investigate the reasons behind difficulties in recruiting patients to randomized controlled trials (RCTs) in psychiatry and to examine a database of RCTs for differences between studies in mental health and other specialities.Methods.A discussion of recent changes in research governance in the UK and Europe followed by an examination of the database of all trials supported by the Health Technology Assessment programme of the National Institute of Health Research in the UK between 1993 and 2007 to determine if three different measures, (i) time between grant approval and study start date, (ii) percentage of additional time given to extend recruitment and (iii) percentage of planned recruitment achieved, changed over the time period studied and differed between mental health, cancer and other medical disciplines.Findings.Despite attempts in the UK to accelerate the process of clinical trials in recent years, there was a significant increase in the extension time for trials to be completed (p = 0.038) and the percentage of planned recruitment to mental health studies (71%) was significantly less than for cancer (90.3%) and other studies (86.1%) (p = 0.032).Summary.These results suggest that, despite the priority afforded to the advancement of RCTs in healthcare, such studies are encountering increasing difficulty in recruiting to time and target. We suggest that this difficulty can be attributed, at least in part, to the excessively byzantine regulation and governance processes for health research in the UK, and unnecessary bureaucracy in the current National Health Service system. Mental health studies appear particularly vulnerable to delay and better systems to facilitate recruitment are required urgently for the evidence base to be improved and facilitate new cost-effective interventions.


2017 ◽  
Vol 33 (S1) ◽  
pp. 117-118 ◽  
Author(s):  
Antonella Negro ◽  
Maria Domenica Camerlingo ◽  
Susanna Maltoni ◽  
Fabio Trimaglio

INTRODUCTION:Rapid reviews are an attractive tool for Health Technology Assessment (HTA) as they may be a support in decision making when time and resources are limited. Rapid reviews are carried out in few weeks (from 3 weeks to 6 months) and require adjustments from standard systematic review methods. Methodology on how to carry out rapid reviews is still debated and guidance regarding the most suitable method to apply is lacking. Kaltenthaler (1) has recently proposed a checklist of items to be considered when undertaking a rapid review. We appraised our rapid assessment on the use of frequency domain (FD)-optical coherence tomography in percutaneous coronary interventions, based on a rapid review of the literature, using the items proposed (1).METHODS:The checklist reports four key points to consider when planning a rapid review: (i) scoping search - needed to quantify the available evidence and to inform rapid review protocol, (ii) results reporting – considering heterogeneity of intervention, comparators, and outcomes, (iii) clear communication with policy makers - ensuring that review responds to the policy question and (iv) reporting on methods - methodology used, strengths and limitations.RESULTS:When we applied the checklist proposed by Kaltenthaler (1) to our rapid review on the use of FD-optical coherences tomography it resulted that: the scoping search revealed no useful systematic reviews to answer policy-makers questions and a high number of relevant studies. For results presentation, we used a narrative synthesis reporting outcome data grouped in domains previously defined by an evidence profile. Domains consisted of technical performance, safety, efficacy, and change in management. No meta-analysis was performed due to paucity of randomized controlled trials (RCTs) for the efficacy domain and high heterogeneity in outcomes measures for technical performance. Analysis of some of the outcomes was extremely time-consuming (technical performance) and did not provide particularly useful information for the commissioning body. A clearer and more intensive dialog with policy makers to adjust extent of research question and/or outcomes to be investigated would have probably improved usability for final users. Description of methods was partial.CONCLUSIONS:The checklist by Kaltenthaler (1) helped us to reflect on the method we used to carry out rapid reviews and to pinpoint possible solutions to improve it.


2016 ◽  
Vol 20 (16) ◽  
pp. 1-214 ◽  
Author(s):  
Rhiannon Whitaker ◽  
Maggie Hendry ◽  
Rabeea’h Aslam ◽  
Andrew Booth ◽  
Ben Carter ◽  
...  

BackgroundThe UK has one of the highest rates of teenage pregnancies in Western Europe. One-fifth of these are repeat pregnancies. Unintended conceptions can cause substantial emotional, psychological and educational harm to teenagers, often with enduring implications for life chances. Babies of teenage mothers have increased mortality and are at a significantly increased risk of poverty, educational underachievement and unemployment later in life, with associated costs to society. It is important to identify effective, cost-effective and acceptable interventions.ObjectivesTo identify who is at the greatest risk of repeat unintended pregnancies; which interventions are effective and cost-effective; and what the barriers to and facilitators of the uptake of these interventions are.Data sourcesWe conducted a multistreamed, mixed-methods systematic review informed by service user and provider consultation to examine worldwide peer-reviewed evidence and UK-generated grey literature to find and evaluate interventions to reduce repeat unintended teenage pregnancies. We searched the following electronic databases: MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and the Health Technology Assessment Database), EMBASE (Excerpta Medicadatabase), British Nursing Index, Educational Resources Information Center, Sociological Abstracts, Applied Social Sciences Index and Abstracts, BiblioMap (the Evidence for Policy and Practice Information and Co-ordinating Centre register of health promotion and public health research), Social Sciences Citation Index (supported by Web of Knowledge), Research Papers in Economics, EconLit (American Economic Association’s electronic bibliography), OpenGrey, Scopus, Scirus, Social Care Online, National Research Register, National Institute for Health Research Clinical Research Network Portfolio and Index to THESES. Searches were conducted in May 2013 and updated in June 2014. In addition, we conducted a systematic search of Google (Google Inc., Mountain View, CA, USA) in January 2014. Database searches were guided by an advisory group of stakeholders.Review methodsTo address the topic’s complexities, we used a structured, innovative and iterative approach combining methods tailored to each evidence stream. Quantitative data (effectiveness, cost-effectiveness, risk factors and effect modifiers) were synthesised with reference to Cochrane guidelines for evaluating evidence on public health interventions. Qualitative evidence addressing facilitators of and barriers to the uptake of interventions, experience and acceptability of interventions was synthesised thematically. We applied the principles of realist synthesis to uncover theories and mechanisms underpinning interventions (what works, for whom and in what context). Finally, we conducted an overarching narrative of synthesis of evidence and gathered service user feedback.ResultsWe identified 8664 documents initially, and 816 in repeat searches. We filtered these to 12 randomised controlled trials (RCTs), four quasi-RCTs, 10 qualitative studies and 53 other quantitative studies published between 1996 and 2012. None of the RCTs was based in the UK. The RCTs evaluated an emergency contraception programme and psychosocial interventions. We found no evidence for effectiveness with regard to condom use, contraceptive use or rates of unprotected sex or use of birth control. Our primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control goup, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78 to 1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with a RR of 0.60 (95% CI 0.39 to 0.93). Many repeat conceptions occurred in the context of poverty, low expectations and aspirations, and negligible opportunities. Service user feedback suggested that there were specific motivations for many repeat conceptions, for example to replace loss or to please a partner. Realist synthesis highlighted that context, motivation, planning for the future and letting young women take control with connectedness and tailoring provide a conceptual framework for future research.LimitationsIncluded studies rarely characterised adolescent pregnancy as intended or unintended, that is interventions to reduce repeat conceptions rarely addressed whether or not pregnancies were intended. Furthermore, interventions were often not clearly defined, had multiple aims and did not indicate which elements were intended to address which aims. Nearly all of the studies were conducted in the USA and focused largely on African American or Hispanic and Latina American populations.ConclusionsWe found no evidence to indicate that existing interventions to reduce repeat teenage pregnancy were effective; however, subsequent births were reduced by home-based interventions. Qualitative and realist evidence helped to explain gaps in intervention design that should be addressed. More theory-based, rigorously evaluated programmes need to be developed to reduce repeat teenage pregnancy in the UK.Study registrationThis study is registered as PROSPERO CRD42012003168. Cochrane registration number: i=fertility/0068.FundingThe National Institute for Health Research Health Technology Assessment programme.


2021 ◽  
pp. 004947552098277
Author(s):  
Madhu Kharel ◽  
Alpha Pokharel ◽  
Krishna P Sapkota ◽  
Prasant V Shahi ◽  
Pratisha Shakya ◽  
...  

Evidence-based decision-making is less common in low- and middle-income countries where the research capacity remains low. Nepal, a lower-middle-income country in Asia, is not an exception. We conducted a rapid review to identify the trend of health research in Nepal and found more than seven-fold increase in the number of published health-related articles between 2000 and 2018. The proportion of articles with Nepalese researchers as the first authors has also risen over the years, though they are still only in two-thirds of the articles in 2018.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Peter van der Graaf ◽  
Lindsay Blank ◽  
Eleanor Holding ◽  
Elizabeth Goyder

Abstract Background The national Public Health Practice Evaluation Scheme (PHPES) is a response-mode funded evaluation programme operated by the National Institute for Health Research School for Public Health Research (NIHR SPHR). The scheme enables public health professionals to work in partnership with SPHR researchers to conduct rigorous evaluations of their interventions. Our evaluation reviewed the learning from the first five years of PHPES (2013–2017) and how this was used to implement a revised scheme within the School. Methods We conducted a rapid review of applications and reports from 81 PHPES projects and sampled eight projects (including unfunded) to interview one researcher and one practitioner involved in each sampled project (n = 16) in order to identify factors that influence success of applications and effective delivery and dissemination of evaluations. Findings from the review and interviews were tested in an online survey with practitioners (applicants), researchers (principal investigators [PIs]) and PHPES panel members (n = 19) to explore the relative importance of these factors. Findings from the survey were synthesised and discussed for implications at a national workshop with wider stakeholders, including public members (n = 20). Results Strengths: PHPES provides much needed resources for evaluation which often are not available locally, and produces useful evidence to understand where a programme is not delivering, which can be used to formatively develop interventions. Weaknesses: Objectives of PHPES were too narrowly focused on (cost-)effectiveness of interventions, while practitioners also valued implementation studies and process evaluations. Opportunities: PHPES provided opportunities for novel/promising but less developed ideas. More funded time to develop a protocol and ensure feasibility of the intervention prior to application could increase intervention delivery success rates. Threats: There can be tensions between researchers and practitioners, for example, on the need to show the 'success’ of the intervention, on the use of existing research evidence, and the importance of generalisability of findings and of generating peer-reviewed publications. Conclusions The success of collaborative research projects between public health practitioners (PHP) and researchers can be improved by funders being mindful of tensions related to (1) the scope of collaborations, (2) local versus national impact, and (3) increasing inequalities in access to funding. Our study and comparisons with related funding schemes demonstrate how these tensions can be successfully resolved.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
◽  

Abstract Patient information material (PIM) is omnipresent in healthcare. It is used to convey information or to familiarize potential end-users to offers of support. PIM recaps or elaborates on relevant information and offers recommendation for action. However, the quality of available PIM varies. When the formal and content-related quality of PIM is suboptimal, it not only fails to be effective but can also lead to uncertainty, misunderstandings, resistance or ignorance (e.g. of a support offer). Highly complex information requires much attention on the quality of the PIM, especially with respect to end-users (e.g. vulnerable groups). Excellent communication through the use of PIM is thus essential within complex interventions. Checklists, such as 'Discern' or 'PEMAT', as well as criteria catalogues or evidence-based patient information standards, may assist in the development, quality assessment and optimization of PIM. The inclusion of the end-users is recommended but for various reasons does not often take place. The innovative “integrated, cross-sectional Psycho-Oncology” (isPO) programme, offers needs-driven, professional support to all adult, newly diagnosed cancer patients early in their sickness trajectory. IsPO was developed in 2018. It was implemented and a formative evaluated in 2019. When developing this programme, different PIM were created top-down by the programme designers. During implementation, it became evident that these PIM materials required further improvement. A testing and optimization process started using the participatory health research (PHR) approach and was completed in a five-month period. A PIM-optimisation team was founded, which included the project partners involved in the network support, self-help organisations and the external evaluation institute. A practical instrument (PIM-checklist) for optimising the isPO-PIM was designed, piloted and used for testing by end-users, isPO service providers, and experts. Based on the recommendations in the checklist, the material was revised accordingly. Additionally, the PIM was completed with the design of two new components. Four optimisation rounds were conducted. The optimized PIM was tested on its comprehensibility (for end-users) and its usability (for service providers). During the presentations, the audience is invited to comment on critical questions that may appear during optimization (e.g. timing). Afterwards, there will be a skill building part with a focus on collaborative learning (45 minutes). First, we will focus on the requirements for a practical instrument that is handy for end-users, service providers and experts (mind mapping exercise). Finally, participants will be able to explore the following topics “World Café” discussion: (1) how to plan, conduct and communicate the development of optimization of PIM in a CI program, (2) what needs to be considered for the optimization (e.g. team composition, resources), and (3) how to continuously achieve end-userś participation. Key messages Excellent PIM are essential for a complex interventiońs success in practice and must include information and foster actionability. the iterative PIM design processes benefits from high user participation.


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