scholarly journals Theoretical approaches to process evaluations of complex interventions in health care: a systematic scoping review protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Tina Quasdorf ◽  
Lauren Clack ◽  
Franziska Laporte Uribe ◽  
Daniela Holle ◽  
Martin Berwig ◽  
...  

Abstract Background Complex 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. Methods The 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. Discussion The 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 registration This study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732.

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
María Lazo-Porras ◽  
Hueiming Liu ◽  
J. Jaime Miranda ◽  
Graham Moore ◽  
Mafalda Burri ◽  
...  

Abstract Background The use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings. Objective Map research using process evaluation in the areas of non-communicable diseases and neglected tropical diseases to inform the gaps in the design and conduct of this type of research in LMICs. Methods Scoping review of process evaluation studies of randomized controlled trials (RCTs) and non-RCTs of complex interventions implemented in LMICs including participants with non-communicable diseases or neglected tropical diseases and their health care providers (physicians, nurses, technicians and others) related to achieve better health for all through reforms in universal coverage, public policy, service delivery and leadership. The aspects that will be evaluated are as follows: (i) available evidence of process evaluation in the areas of non-communicable diseases and neglected tropical diseases such as frameworks and theories, (ii) methods applied to conduct process evaluations and (iii) gaps between the design of the intervention and its implementation that were identified through the process evaluation. Studies published from January 2008. Exclusion criteria are as follows: not peer reviewed articles, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and non-human research. Discussion This scoping review will map the evidence of process evaluations conducted in LMICs. It will also identify the methods they used to collect and interpret data, how different theories and frameworks were used and lessons from the implementation of complex interventions. This information will allow researchers to conduct better process evaluations considering special characteristics from countries with limited human resources, scarce data available and limited access to health care.


2022 ◽  
Vol 13 ◽  
Author(s):  
Ahmed M. Negm ◽  
Adrian Salopek ◽  
Mashal Zaide ◽  
Victoria J. Meng ◽  
Carlos Prada ◽  
...  

Purpose: The coronavirus disease-19 (COVID-19) was declared a pandemic by the World Health Organization in March 2020. COVID-19, caused by SARS-CoV-2 has imposed a significant burden on health care systems, economies, and social systems in many countries around the world. The provision of rehabilitation services for persons with active COVID-19 infection poses challenges to maintaining a safe environment for patients and treating providers.Materials and Methods: Established frameworks were used to guide the scoping review methodology. Medline, Embase, Pubmed, CINAHL databases from inception to August 1, 2020, and prominent rehabilitation organizations’ websites were searched.Study Selection: We included articles and reports if they were focused on rehabilitation related recommendations for COVID-19 patients, treating providers, or the general population.Data Extraction: Pairs of team members used a pre-tested data abstraction form to extract data from included full-text articles. The strength and the quality of the extracted recommendations were evaluated by two reviewers using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.Results: We retrieved 6,468 citations, of which 2,086 were eligible for review, after duplicates were removed. We excluded 1,980 citations based on title and abstract screening. Of the screened full-text articles, we included all 106 studies. A summary of recommendations is presented. We assessed the overall evidence to be strong and of fair quality.Conclusion: The rehabilitation setting, and processes, logistics, and patient and healthcare provider precaution recommendations identified aim to reduce the spread of SARS-CoV-2 infection and ensure adequate and safe rehabilitation services, whether face-to-face or through teleservices. The COVID-19 pandemic is rapidly changing. Further updates will be needed over time in order to incorporate emerging best evidence into rehabilitation guidelines.


2020 ◽  
Author(s):  
Tobias N Bonten ◽  
Anneloek Rauwerdink ◽  
Jeremy C Wyatt ◽  
Marise J Kasteleyn ◽  
Leonard Witkamp ◽  
...  

UNSTRUCTURED Despite the increase in use and high expectations of digital health solutions, scientific evidence about the effectiveness of electronic health (eHealth) and other aspects such as usability and accuracy is lagging behind. eHealth solutions are complex interventions, which require a wide array of evaluation approaches that are capable of answering the many different questions that arise during the consecutive study phases of eHealth development and implementation. However, evaluators seem to struggle in choosing suitable evaluation approaches in relation to a specific study phase. The objective of this project was to provide a structured overview of the existing eHealth evaluation approaches, with the aim of assisting eHealth evaluators in selecting a suitable approach for evaluating their eHealth solution at a specific evaluation study phase. Three consecutive steps were followed. Step 1 was a systematic scoping review, summarizing existing eHealth evaluation approaches. Step 2 was a concept mapping study asking eHealth researchers about approaches for evaluating eHealth. In step 3, the results of step 1 and 2 were used to develop an “eHealth evaluation cycle” and subsequently compose the online “eHealth methodology guide.” The scoping review yielded 57 articles describing 50 unique evaluation approaches. The concept mapping study questioned 43 eHealth researchers, resulting in 48 unique approaches. After removing duplicates, 75 unique evaluation approaches remained. Thereafter, an “eHealth evaluation cycle” was developed, consisting of six evaluation study phases: conceptual and planning, design, development and usability, pilot (feasibility), effectiveness (impact), uptake (implementation), and all phases. Finally, the “eHealth methodology guide” was composed by assigning the 75 evaluation approaches to the specific study phases of the “eHealth evaluation cycle.” Seventy-five unique evaluation approaches were found in the literature and suggested by eHealth researchers, which served as content for the online “eHealth methodology guide.” By assisting evaluators in selecting a suitable evaluation approach in relation to a specific study phase of the “eHealth evaluation cycle,” the guide aims to enhance the quality, safety, and successful long-term implementation of novel eHealth solutions.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039543
Author(s):  
Jia Qi Lee ◽  
Kate Ying ◽  
Penny Lun ◽  
Keng Teng Tan ◽  
Wendy Ang ◽  
...  

ObjectivePolypharmacy occurs in approximately 30% of older adults aged 65 years or more, particularly among those with multimorbidity. With polypharmacy, there is an associated risk of potentially inappropriate prescribing (PIP). The aims of this scoping review were to (1) identify the intervention elements that have been adopted to reduce PIP in the outpatient setting and (2) determine the behaviour change wheel (BCW) intervention functions performed by each of the identified intervention elements.DesignScoping reviewData sourcesPubMed, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Web of Science and Cochrane Library databases, grey literature sources, six key geriatrics journals and the reference lists of review papers.Study selectionAll studies reporting an intervention or strategy that addressed PIP in the older adult population (age ≥65) with multimorbidity in the outpatient setting and in which the primary prescriber is the physician.Data extractionData extracted from the included studies can be broadly categorised into (1) publication details, (2) intervention details and (3) results. This was followed by data synthesis and analysis based on the BCW framework.ResultsOf 8195 studies yielded, 80 studies were included in the final analysis and 14 intervention elements were identified. An average of two to three elements were adopted in each intervention. The three most frequently adopted intervention elements were medication review (70%), training (26.3%) and tool/instrument(s) (22.5%). Among medication reviews, 70% involved pharmacists. The 14 intervention elements were mapped onto five intervention functions: ‘education’, ‘persuasion’, ‘training’, ‘environmental restructuring’ and ‘enablement’.ConclusionPIP is a multifaceted problem that involves multiple stakeholders. As such, interventions that address PIP require multiple elements to target the behaviour of the various stakeholders. The intervention elements and their corresponding functions identified in this scoping review will serve to inform the design of complex interventions that aim to reduce PIP.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e025127 ◽  
Author(s):  
Hueiming Liu ◽  
Alim Mohammed ◽  
Janani Shanthosh ◽  
Madeline News ◽  
Tracey-Lea Laba ◽  
...  

ObjectiveProcess evaluations (PEs) alongside randomised controlled trials of complex interventions are valuable because they address questions of for whom, how and why interventions had an impact. We synthesised the methods used in PEs of primary care interventions, and their main findings on implementation barriers and facilitators.DesignSystematic review using the UK Medical Research Council guidance for PE as a guide.Data sourcesAcademic databases (MEDLINE, SCOPUS, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE and Global Health) were searched from 1998 until June 2018.Eligibility criteriaWe included PE alongside randomised controlled trials of primary care interventions which aimed to improve outcomes for patients with non-communicable diseases.Data extraction and synthesisTwo independent reviewers screened and conducted the data extraction and synthesis, with a third reviewer checking a sample for quality assurance.Results69 studies were included. There was an overall lack of consistency in how PEs were conducted and reported. The main weakness is that only 30 studies were underpinned by a clear intervention theory often facilitated by the use of existing theoretical frameworks. The main strengths were robust sampling strategies, and the triangulation of qualitative and quantitative data to understand an intervention’s mechanisms. Findings were synthesised into three key themes: (1) a fundamental mismatch between what the intervention was designed to achieve and local needs; (2) the required roles and responsibilities of key actors were often not clearly understood; and (3) the health system context—factors such as governance, financing structures and workforce—if unanticipated could adversely impact implementation.ConclusionGreater consistency is needed in the reporting and the methods of PEs, in particular greater use of theoretical frameworks to inform intervention theory. More emphasis on formative research in designing interventions is needed to align the intervention with the needs of local stakeholders, and to minimise unanticipated consequences due to context-specific barriers.PROSPERO registration numberCRD42016035572.


2020 ◽  
Author(s):  
Tobias N Bonten ◽  
Anneloek Rauwerdink ◽  
Jeremy C Wyatt ◽  
Marise J Kasteleyn ◽  
Leonard Witkamp ◽  
...  

BACKGROUND Despite the increase in use and high expectations of digital health solutions, scientific evidence about the effectiveness of electronic health (eHealth) and other aspects such as usability and accuracy is lagging behind. eHealth solutions are complex interventions, which require a wide array of evaluation approaches that are capable of answering the many different questions that arise during the consecutive study phases of eHealth development and implementation. However, evaluators seem to struggle in choosing suitable evaluation approaches in relation to a specific study phase. OBJECTIVE The objective of this project was to provide a structured overview of the existing eHealth evaluation approaches, with the aim of assisting eHealth evaluators in selecting a suitable approach for evaluating their eHealth solution at a specific evaluation study phase. METHODS Three consecutive steps were followed. Step 1 was a systematic scoping review, summarizing existing eHealth evaluation approaches. Step 2 was a concept mapping study asking eHealth researchers about approaches for evaluating eHealth. In step 3, the results of step 1 and 2 were used to develop an “eHealth evaluation cycle” and subsequently compose the online “eHealth methodology guide.” RESULTS The scoping review yielded 57 articles describing 50 unique evaluation approaches. The concept mapping study questioned 43 eHealth researchers, resulting in 48 unique approaches. After removing duplicates, 75 unique evaluation approaches remained. Thereafter, an “eHealth evaluation cycle” was developed, consisting of six evaluation study phases: conceptual and planning, design, development and usability, pilot (feasibility), effectiveness (impact), uptake (implementation), and all phases. Finally, the “eHealth methodology guide” was composed by assigning the 75 evaluation approaches to the specific study phases of the “eHealth evaluation cycle.” CONCLUSIONS Seventy-five unique evaluation approaches were found in the literature and suggested by eHealth researchers, which served as content for the online “eHealth methodology guide.” By assisting evaluators in selecting a suitable evaluation approach in relation to a specific study phase of the “eHealth evaluation cycle,” the guide aims to enhance the quality, safety, and successful long-term implementation of novel eHealth solutions.


10.2196/17774 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e17774
Author(s):  
Tobias N Bonten ◽  
Anneloek Rauwerdink ◽  
Jeremy C Wyatt ◽  
Marise J Kasteleyn ◽  
Leonard Witkamp ◽  
...  

Background Despite the increase in use and high expectations of digital health solutions, scientific evidence about the effectiveness of electronic health (eHealth) and other aspects such as usability and accuracy is lagging behind. eHealth solutions are complex interventions, which require a wide array of evaluation approaches that are capable of answering the many different questions that arise during the consecutive study phases of eHealth development and implementation. However, evaluators seem to struggle in choosing suitable evaluation approaches in relation to a specific study phase. Objective The objective of this project was to provide a structured overview of the existing eHealth evaluation approaches, with the aim of assisting eHealth evaluators in selecting a suitable approach for evaluating their eHealth solution at a specific evaluation study phase. Methods Three consecutive steps were followed. Step 1 was a systematic scoping review, summarizing existing eHealth evaluation approaches. Step 2 was a concept mapping study asking eHealth researchers about approaches for evaluating eHealth. In step 3, the results of step 1 and 2 were used to develop an “eHealth evaluation cycle” and subsequently compose the online “eHealth methodology guide.” Results The scoping review yielded 57 articles describing 50 unique evaluation approaches. The concept mapping study questioned 43 eHealth researchers, resulting in 48 unique approaches. After removing duplicates, 75 unique evaluation approaches remained. Thereafter, an “eHealth evaluation cycle” was developed, consisting of six evaluation study phases: conceptual and planning, design, development and usability, pilot (feasibility), effectiveness (impact), uptake (implementation), and all phases. Finally, the “eHealth methodology guide” was composed by assigning the 75 evaluation approaches to the specific study phases of the “eHealth evaluation cycle.” Conclusions Seventy-five unique evaluation approaches were found in the literature and suggested by eHealth researchers, which served as content for the online “eHealth methodology guide.” By assisting evaluators in selecting a suitable evaluation approach in relation to a specific study phase of the “eHealth evaluation cycle,” the guide aims to enhance the quality, safety, and successful long-term implementation of novel eHealth solutions.


2019 ◽  
Author(s):  
Stephanie Aboueid ◽  
Rebecca Hsin-Ling Liu ◽  
Piraveena Sabesan

BACKGROUND Given the rapid digitization of health care and abundance of available data, there is a great interest in how to leverage these advancements into evidence-based practice. Algorithms and artificial intelligence have the potential to improve health care, reduce costs, and contribute to evidence-based practice. An in-depth examination of the available evidence is needed to elucidate the cost-effectiveness of algorithms and AI techniques applied in health care. OBJECTIVE The goal of this scoping review will be to map the literature on the cost-effectiveness of algorithms and AI techniques applied in health care. The current review protocol provides an overview of the steps taken to complete the review. METHODS The PRISMA-Scoping Review checklist will be used to guide the reporting of the scoping review. Three main concepts include: 1) health care costs; 2) algorithms and AI techniques; and 3) cost-effectiveness analysis. The following databases will be used: PubMed, Scopus, ACM Digital Library, IEEE, Google Scholar, Econlit, OpenGrey, and ProQuest Dissertations and Theses. Two researchers (SA and RHL) will independently screen the titles, abstracts, and full texts, while a third researcher (PS) will negotiate any discrepancies, until consensus is reached. RESULTS Article retrieval, data extraction, and interpretation are currently underway. CONCLUSIONS Findings from the review may provide invaluable insights on the cost-effectiveness of algorithms and AI techniques applied in health care. Given that health care dollars are scarce, it is important to know which algorithms and AI techniques are worth the upfront investments. As a result, decision-makers will be able to identify which algorithms or AI technique would be of value for their specific context. This review will also identify key knowledge gaps in the literature and will provide next steps for future research. CLINICALTRIAL Not applicable - this is a scoping review.


Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 527 ◽  
Author(s):  
Cristian Fernandez-Palomo ◽  
Jennifer Fazzari ◽  
Verdiana Trappetti ◽  
Lloyd Smyth ◽  
Heidrun Janka ◽  
...  

Background: Microbeam Radiation Therapy (MRT) is an innovative approach in radiation oncology where a collimator subdivides the homogeneous radiation field into an array of co-planar, high-dose beams which are tens of micrometres wide and separated by a few hundred micrometres. Objective: This scoping review was conducted to map the available evidence and provide a comprehensive overview of the similarities, differences, and outcomes of all experiments that have employed animal models in MRT. Methods: We considered articles that employed animal models for the purpose of studying the effects of MRT. We searched in seven databases for published and unpublished literature. Two independent reviewers screened citations for inclusion. Data extraction was done by three reviewers. Results: After screening 5688 citations and 159 full-text papers, 95 articles were included, of which 72 were experimental articles. Here we present the animal models and pre-clinical radiation parameters employed in the existing MRT literature according to their use in cancer treatment, non-neoplastic diseases, or normal tissue studies. Conclusions: The study of MRT is concentrated in brain-related diseases performed mostly in rat models. An appropriate comparison between MRT and conventional radiotherapy (instead of synchrotron broad beam) is needed. Recommendations are provided for future studies involving MRT.


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