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Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

ABSTRACT: Introduction: In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs.

Method and analysis: This protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O'Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted.

Ethics and dissemination: This scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

SUBMITTER: Baghbanian A

PROVIDER: S-EPMC7705549 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

Baghbanian Abdolvahab A Merlin Tracy T Carter Drew D Wang Shuhong S

BMJ open 20201130 11

<h4>Introduction</h4>In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multipl ...[more]

PMID: 33257482

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Project description:BackgroundBenefit-risk assessment (BRA) is used in multiple phases along the health technology's life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA's application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.Methods and analysisThis scoping review protocol was developed following the framework proposed by Arksey and O'Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.Ethics and disseminationThis review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.Trial registration numberOpen Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

Project description:BackgroundHealth technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices.Main bodyA scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015-2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed.ConclusionHTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.

Project description:INTRODUCTION:There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions. METHODS AND ANALYSIS:Our review will follow the Joanna Briggs Institute scoping review methods manual. We will search for relevant studies in MEDLINE, EMBASE and Cochrane Library databases. Moreover, we will carry out lateral searches from the reference lists of the included studies, as well as from the lists of articles citing the included ones. One reviewer will screen the full list, which will be randomly split into two halves and independently screened by the other two reviewers. Two reviewers will perform data extraction independently. Discrepancies will be solved through discussion. In addition, this search strategy will be supplemented by a grey literature search. The interventions found will be classified as assessed or suggested, as well as according to different criteria, in relation to their target (journal policies, journal editors, authors, reviewers, funders, ethical boards or others) or the research stage at which they are performed (design, conducting, reporting or peer review). Descriptive statistical analysis will be performed. ETHICS AND DISSEMINATION:A paper summarising the findings from this review will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding and a broader perspective on how the problem of adhering better to reporting guidelines has been tackled so far. This could be a major first step towards developing future strategies to improve compliance with reporting guidelines in health research.

Project description:IntroductionTechnology-mediated self-guided interventions (TMSGIs) for addictive disorders represent promising adjuncts and alternatives to traditional treatment approaches (eg, face-to-face psychotherapy). However, meaningful evaluation of such interventions remains elusive given the lack of consistent terminology and application. Preliminary findings suggest that TMSGIs are useful but engagement remains modest for various reasons reported by users, including lack of personalisation. The aim of this review is to explore how TMSGIs have been defined and applied in addictions populations with an emphasis on technical and logistical features associated with greater user engagement.Methods and analysisThis scoping review protocol was developed in accordance with the Arksey and O'Malley framework. Articles from electronic databases (ie, PsycINFO, Embase, MEDLINE and CINAHL) will be included if they targeted adolescents or adults with one or more substance or behavioural addictions, excessive behaviours or aspects thereof (eg, cravings) using a privately accessible technology-mediated intervention. Two independent reviewers will screen titles and abstracts for relevance before commencing full-text reviews. Extracted data will be presented in descriptive, tabular and graphical summaries as appropriate.Ethics and disseminationEthics committee approval is not required for this study. Review findings will be used to guide the development of preliminary recommendations for real-time addiction intervention development and provision. Emphasis will be placed on practical considerations of user engagement, accessibility, usability and cost. Knowledge users, including clinicians, researchers and people with lived experience, will be engaged for development of one such intervention following publication of review findings.RegistrationThis scoping review was registered with the Open Science Framework on 15 April 2022 and can be located at http://www.osf.io/3utp9/.

Project description:BackgroundComplex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations.MethodsThe design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by "hand searching" techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team.DiscussionThe findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study.Systematic review registrationThis study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732 .

Project description:Addressing health workforce cultural competence is a common approach to improving health service quality for culturally and ethnically diverse groups. Research evidence in this area is primarily focused on cultural competency training and its effects on practitioners' knowledge, attitudes, skills and behaviour. While improvements in measures of healthcare practitioner cultural competency and other healthcare outcomes have been reported, there are concerns around evidence strength and quality. This scoping review reports on the intervention strategies, outcomes, and measures of included studies with the purpose of informing the implementation and evaluation of future interventions to improve health workforce cultural competence.This systematic scoping review was completed as part of a larger systematic literature search conducted on cultural competence intervention evaluations in health care in Canada, the United States, Australia and New Zealand published from 2006 to 2015. Overall, 64 studies on cultural competency interventions were found, with 16 aimed directly at the health workforce.There was significant heterogeneity in workforce intervention strategies, measures and outcomes reported across studies making comparisons of intervention effects difficult. The two main workforce intervention strategies identified were cultural competency training and other professional development interventions including other training and mentoring. Positive outcomes were commonly reported for improved practitioner knowledge (9/16), skills (7/16), and attitudes/beliefs (5/16). Although health care (6/16) and health (2/16) outcomes were reported in some studies there was very limited evidence of positive intervention impacts. Only four studies utilised existing validated measurement tools to assess intervention outcomes.Training and development of the health workforce remain a principle strategy towards the goal of improved cultural competence in health services and systems. Diverse approaches are available to increase health workforce cultural competence. However, the effects of interventions beyond practitioner knowledge and attitudes remains unclear. Assessment of practitioner behavioural outcomes as well as measures of intervention impact on healthcare and health outcomes are needed to build a stronger evidence base.

Project description:BackgroundThe popularity of yoga and the understanding of its potential health benefits have recently increased. Unfortunately, not everyone can easily engage in in-person yoga classes. Over the past decade, the use of remotely delivered yoga has increased in real-world applications. However, the state of the related scientific literature is unclear.ObjectiveThis scoping review aimed to identify gaps in the literature related to the remote delivery of yoga interventions, including gaps related to the populations studied, the yoga intervention characteristics (delivery methods and intervention components implemented), the safety and feasibility of the interventions, and the preliminary efficacy of the interventions.MethodsThis scoping review was conducted in accordance with the PRISMA-ScR (Preferred Reporting Item for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Scientific databases were searched throughout April 2021 for experimental studies involving yoga delivered through technology. Eligibility was assessed through abstract and title screening and a subsequent full-article review. The included articles were appraised for quality, and data were extracted from each article.ResultsA total of 12 studies of weak to moderate quality were included. Populations varied in physical and mental health status. Of the 12 studies, 10 (83%) implemented asynchronous delivery methods (via prerecorded material), 1 (8%) implemented synchronous delivery methods (through videoconferencing), and 1 (8%) did not clearly describe the delivery method. Yoga interventions were heterogeneous in style and prescribed dose but primarily included yoga intervention components of postures, breathing, and relaxation and meditation. Owing to the heterogeneous nature of the included studies, conclusive findings regarding the preliminary efficacy of the interventions could not be ascertained.ConclusionsSeveral gaps in the literature were identified. Overall, this review showed that more attention needs to be paid to yoga intervention delivery methods while designing studies and developing interventions. Decisions regarding delivery methods should be justified and not made arbitrarily. Studies of high methodological rigor and robust reporting are needed.

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Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

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Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

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