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Mapping frameworks for synthesizing qualitative evidence in health technology assessment

Published online by Cambridge University Press:  13 November 2024

Marilia Mastrocolla de Almeida Cardoso*
Affiliation:
Hospital das Clinicas Botucatu, Botucatu, Brazil The Brazilian Centre for Evidence-based Healthcare – A JBI Centre of Excellence, Botucatu, SP, Brazil
Rafael Thomaz Marques
Affiliation:
Faculty of Medicine, São Paulo State University, Botucatu, SP, Brazil
Juliana Machado-Rugolo
Affiliation:
Hospital das Clínicas da Faculdade de Medicina de Botucatu, Botucatu, SP, Brazil
Lehana Thabane
Affiliation:
Health Research, Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada Biostatistics Unit, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada Faculty of Health Sciences, University of Johannesburg, Auckland Park, Gauteng, South Africa
Vilanice Alves de Araújo Püschel
Affiliation:
The Brazilian Centre for Evidence-based Healthcare – A JBI Centre of Excellence, Botucatu, SP, Brazil School of Nursing, University of São Paulo, SP, Brazil
Silke Anna Theresa Weber
Affiliation:
Hospital das Clinicas Botucatu, Botucatu, Brazil Faculty of Medicine, São Paulo State University, Botucatu, SP, Brazil
Rosimary Terezinha Almeida
Affiliation:
Biomedical Engineering Program COPPE, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil
Graciela Paula do Nascimento Duque
Affiliation:
Biomedical Engineering Program COPPE, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil Brazilian Hospital Services Company – EBSERH, Brazil
Cristiane Cardoso De Paula
Affiliation:
Brazilian Hospital Services Company – EBSERH, Brazil Federal University of Santa Maria, Santa Maria, RS, Brazil
Luciane Cruz Lopes
Affiliation:
Pharmaceutical Science Graduate Course, University of Sorocaba, Sorocaba, SP, Brazil
Mariana Gabriel
Affiliation:
Faculty of Dentistry, University of São Paulo, Brazil
Sybelle Drumond
Affiliation:
Rio de Janeiro State Murcoviscidosis Association, Brazil
Clarice Maria Rodrigues
Affiliation:
Fiocruz Strategic Studies Center, Brazil Hospital and health complex, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil
Meredith Vanstone
Affiliation:
Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada
*
Corresponding author: Marilia Mastrocolla de Almeida Cardoso; Email: [email protected]
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Abstract

Objectives

Health Technology Assessment (HTA) practitioners recognize the significance of qualitative methodologies that focus on how a technology is feasible, meaningfulness, acceptable, and equitable. This mapping aimed to delineate the frameworks employed to synthesize qualitative evidence and assess the quality of synthesis in HTA .

Methods

Mapping was conducted using Medline, LILACS, CINAHL, Embase, Web of Science, Scopus, PsycINFO, Cochrane Library, JBI, and ScienceDirect databases. Gray literature searches included PROQUEST, Open Grey, Canadian Agency for Drugs and Technologies in Health’s Grey Matters, Google Scholar, and HTA agency websites. The inclusion criteria were centered on global qualitative evidence synthesis frameworks. The data are presented in the tables.

Results

Of the 2054 articles, 31 were included, mostly from Europe. Guide was the type of document more cited, and most authors are from HTA agencies and universities. Incorporating both patient and family perspectives is the most cited reason for include qualitative evidence. Regardless of the framework or tool, SPICE was the main acronym, and RETREAT was preferred for approach selection. Thematic synthesis dominated analytic methods, and CASP was the primary quality appraisal tool. GRADE-CERQual graded evidence synthesis, with ENTREQ as the top reporting guidance. The GRADE evidence-to-decision framework was mentioned for recommendations.

Conclusion

This mapping highlights the movement incorporate qualitative evidence in HTA employing specific frameworks. Despite the similarities among documents, most of them describe part of the process to synthesize qualitative evidence. Standardizing procedures to incorporate qualitative evidence into HTA can enhance decision-making. These findings offer essential considerations for HTA practice.

Type
Method
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This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2024. Published by Cambridge University Press

Introduction

Health Technology Assessment (HTA) is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. Its objective is to inform decision-making to promote an equitable, efficient, and high-quality health system (Reference O’Rourke, Oortwijn and Schuller1). Through this process, clinical guidelines or recommendation reports are developed to provide decision-makers with the best possible information. More recently, HTA practitioners have recognized that assessments are stronger when they integrate both quantitative and qualitative evidence (Reference Booth2Reference Flemming and Noyes4). Qualitative evidence expands the evaluation “explaining why interventions are or are not effective from a person centered perspective, and address questions related to the usability, meaningfulness, feasibility and appropriateness of interventions.” (Reference Lockwood, Porritt, Munn, Rittenmeye, Salmond, Bjerrum, Aromataris and Munn5, pg 12), which includes acceptability and equity (Reference Booth2).

According to Langlois et al (Reference Langlois, Tunçalp, Norris, Askew and Ghaffar6) qualitative evidence highlights relevant aspects of the complex health decision-making process, such as the needs, values, perceptions, and experiences of stakeholders (policymakers, providers, communities and patients).

One way to strengthen the power of qualitative data is to combine qualitative primary studies and their findings. Through evidence synthesis of primary studies, it is possible to produce an stronger evidence that goes beyond the findings of each individual studies (Reference Carroll7).

Globally, authoritative processes exist for the identifying, synthesizings and reporting quantitative data during HTA. Guidelines from HTA agencies present similar instructions for conducting a systematic review of effectiveness, as well as the process to determine the quality of evidence. This similarity allows homogenization, comparison among different contexts, standardization, and the ability to update previously generated information (810).

Outside the HTA field, similar approaches are published to describe how tosummarizate qualitative evidence (Reference Lockwood, Porritt, Munn, Rittenmeye, Salmond, Bjerrum, Aromataris and Munn5;11;Reference Pearson, Robertson-Malt and Rittenmeyer12), how to appraise of the quality of evidence, and methods to aggregate qualitative findings (Reference Noyes, Booth, Cargo, Flemming, Harden, Harris, Higgins, Thomas, Chandler, Cumpston, Li and Page13Reference Munn, Porritt, Lockwood and Person23).

However, according to some authors, the role of qualitative research in HTA is still underway and is sometimes marginally understood.

According to Germeni et al. (Reference Germeni and Szabo24), instructions related to problems of acceptability and the subjective value of stakeholders, as well as contextual factors associated with the implementation of health innovations, have been largely disregarded. A recent study by Szabo et al. (Reference Szabo, Hawkins and Germeni25) demonstrated that although patient-based evidence was common in the submissions of the National Institute for Health and Care Excellence (NICE) and the Canada’s Drug Agency (CADTH), only 14/107 and 24/124 submissions, respectively, involved formal qualitative data collection.

Wang et al. (Reference Wang, Liang, Lu, Shi, Zhang and Cao26) analyzed how qualitative evidence was employed in the guideline development process. The authors concluded that although most of the included guidelines were of high quality, there were limitations, such as the lack of involvement of any specialist in qualitative research, lack of quality assessment of the synthesis of qualitative evidence, and lack of detail when reporting the level of quality of the evidence and its recommendations.

A paper exploring the implications of qualitative evidence synthesis in guideline, to overcome this challenge was published. The authors offer a guidance on the choice of qualitative evidence synthesis methodology in the context of guideline developers. Flemming et al. (Reference Flemming, Booth, Garside, Tunçalp and Noyes3)

In the HTA field, some agencies have begun to include information on how to include qualitative evidence synthesis in the assessment process.

In 2019, the Scottish Intercollegiate Guidelines Network (SIGN) included qualitative summaries in its HTA processes to reduce the variance between practice and outcomes identifying individuals’ perspectives based on their lived experiences (11).

In 2020, the Decision Support Unit, an external assessment center based at the University of Sheffield and commissioned by the NICE provided research and training resources to support the Institute’s Center for Health Technology Evaluation Programs, summarizing methodological developments that occurrefrom 2012 to 2020 by examining and critiquing existing mentions of qualitative evidence in PMG9 (Guide to the Methods of Technology Appraisal) and other relevant NICE methods (Reference Booth2).

Another initiative was developed by the independent Institute for Quality and Efficiency in Health Care from Germany, which presented a document called “General Methods” to guide the sequence of the individual steps in producing the work results in the HTA field and included qualitative evidence as a topic. (27)

Therefore, despite the relevance of the findings from qualitative evidence synthesis, there is limited guidance on how to assess and use this evidence in policy and practice (Reference Langlois, Tunçalp, Norris, Askew and Ghaffar6).

In light of this challenge, a preliminary topic search was conducted using PROSPERO, Open Science Framework, MEDLINE, Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis to identify systematic or scoping reviews that analyzed how the process of qualitative evidence synthesis has been proposed in field of HTA. Only one review of the literature was found, which was published in 1999. This review evaluated the use of qualitative methods for HTA (Reference Murphy, Dingwall, Greatbatch, Parker and Watson28). According to the authors, qualitative approaches and techniques have both strengths and limitations. The results demonstrate that qualitative research, conducted and analyzed correctly, can provide crucial information on the implementation and impact of health technologies (Reference Murphy, Dingwall, Greatbatch, Parker and Watson28). However, the authors did not examine the evidence synthesis process, considering what type of document guided this process and which instructions was provided.

This review aimed to map and describe the frameworks used to include, synthesize, and evaluate the quality of qualitative evidence in the HTA context, to identify the similarities and differences between approaches.

Methods

The proposed mapping was consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) (Reference Peters, Godfrey, McInerney, Munn, Tricco, Khalil, Aromataris and Munn29;Reference Tricco, Lillie, Zarin, O’Brien, Colquhoun and Levac30). The protocol was registered at OSF number https://doi.org/10.17605/OSF.IO/P65FC, and was previously published (Reference McMeekin, Wu, Germeni and Briggs32).

Review question(s)

What documents address the frameworks for synthesizing qualitative evidence for applications in HTA?

What methodological processes are proposed for synthesizing qualitative evidence within an HTA process (e.g., objective, review question, synthesis process, data quality assessment, evidence grading, and form of presentation and incorporation of data in the HTA report)?

Types of sources

This mapping includesd guidelines, reports, text and opinion papers, and other study designs for the proposed mapping.

Search strategy

A search strategy aimed at locating published and unpublished documents up to June 2023, such as guidelines, reports, systematic reviews, texts, and opinion papers, was used. An initial limited search of MEDLINE (PubMed) and Embase was conducted to identify relevant articles. The text words contained in the titles and abstracts the relevant articles and the index terms used to describe the articles were used to develop a complete search strategy for Medline (Pubmed), LILACS (BVS), CINAHL (EBSCO), Embase (Elsevier), Web of Science, Scopus (Elsevier), Cochrane Library, JBI Database, and Science Direct. Grey literature was searched on the PROQUEST, Open Grey, CADTH’s Grey Matters, Google Scholar, and HTA agency websites. The search strategy was adapted for each information source, including all identified keywords and index terms (see Supplementary material I). The reference lists of the documents included in the review were screened for additional papers.

Articles published in English, French, Spanish, Portuguese, German, or Italian were included, corresponding with the team’s expertise. Time restrictions were not imposed.

Inclusion criteria

The acronym used was the PCC (Population, Concept, and Context). The population consisted of eligible documents that provided frameworks for synthesizing qualitative evidence for any technology, audience, or context. In this review, the term “frameworks” is used to refer to supporting structures around which something can be built. Considering” Framework” as a tool to guide the developer through a sequence of steps to complete a procedure.” (Reference McKenzie, Brennan, Higgins, Thomas, Chandler, Cumpston, Li, Page and Welch33).

The concept of this review is the application of qualitative evidence synthesis (QES) for HTA. Evidence synthesis is the process of combining data from the included studies to conclude a body of evidence. This process involves synthesizing study characteristics and statistically synthesizing quantitative data or aggregating qualitative findings (Reference Bertram, Dhaene and Tan-Torres34). The concept of HTA follows the World Health Organization (WHO) guidelines.

Systematic evaluation of the properties, effects, and/or impacts of health technologies and interventions. It -encompasses both the direct, intended consequences of technologies and interventions, as well as their indirect, unintended consequences. This approach is used to inform policy and decision-making in health care, particularly regarding how best to allocate limited funds to health interventions and technologies. Interdisciplinary groups conduct assessment using explicit analytical frameworks, drawing on clinical, epidemiological, health economic, and other information and methodologies. It may be applied to interventions, such as including a new medicine in a reimbursement scheme, rolling-out broad public health programs (such as immunization or screening for cancer), priority setting in health care, identifying health interventions that produce the greatest health gain, offering value for money, setting prices for medicines and other technologies based on their cost-effectiveness, and formulating clinical guidelines (Reference Page, McKenzie, Bossuyt, Boutron, Goffmann and Mulrow35).

This review included documents published in any context.

Study or source of evidence selection

Following the search, all identified records were collated and uploaded to EndNote 20/2020 (Clarivate Analytics, PA, USA), and duplicates were removed. Two independent reviewers screened titles and abstracts to assess the inclusion criteria. Potentially relevant papers were retrieved in full and evaluated in detail by two independent reviewers based on the inclusion criteria. Reasons for excluding full-text documents were recorded and reported in the scoping review. Any disagreements between the reviewers at any stage of the selection process were resolved through discussion or consultation with a third reviewer. The search results were reported in full in the final scoping review and presented as a PRISMA flow diagram (Reference Levac, Colquhoun and O’Brien36).

Data extraction

Data were extracted by two independent reviewers using a data extraction instrument developed by them (Appendix II). The data included specific details about the bibliographic characteristics of the documents (e.g., year, proponent, and type of document) and information related to the concept relevant to the review question, including, but not limited to, how the authors define QES, plan, conduct, and interpret the synthesis of qualitative evidence; the acronym to guide the elaboration of the review question; the selection of outcomes; the outcomes reported by the participants; the instrumental tools to assess the methodological quality of the studies; the methods of extracting, analyzing, and synthesizing the findings; how to grade the evidence(s); and the development of recommendations. Any reviewer disagreements were resolved through discussion. No author of any document was contacted to request missing or additional data.

Data analysis and presentation

The evidence presented should respond directly to the review objective and question(s). The data are presented graphically and in tabular form. A narrative summary accompanies the tabulated, and charted results and describes how the results relate to the objectives and questions of the review (Reference Pollock, Peters and Khalil37).

Patients, HTA unit members, researchers with experience in the HTA process and methods, and researchers with expertise in qualitative evidence synthesis were invited to participate in the discussions. The experts had access to the results in advance to inform their insights and suggestions.

Results

A total of 2,054 records were selected, with 165 duplicates. After reading the titles and abstracts, 1,997 documents were excluded. Fifty-seven documents were subjected to full-text reading, of which 40 did not meet the inclusion criteria, and 17 documents were considered eligible. In addition, nine records were added from other sources, such as HTA agencies or thesis databases, and five more records were added from the references, resulting in 31 documents (Figure 1).

Figure 1. Document selection process, stages of title and summary reading, and full reading.

Characteristics of the documents

General characterization data were mapped regarding the document’s region of origin and authors, document format, year of publication, type of organization responsible for the document, and whether the responsible party was classified as a health technology agency (Table 1).

Table 1. Characteristics of the document based on the region, HTA agency, document type, and author’s context

The synthesis of the data can be accessed in Figure 2.

Figure 2. Characterization of the documents.

Regarding the origin of the documents, there is a predominance of publications from Europa (n = 25, 81 percent), especially the United Kingdom, Sweden, and Germany. South America (Reference Barreto and Lewin38), multiple-regions (Reference Lockwood, Munn and Porritt21), and North America and Europe (Reference Campbell, Weeks, Booth, Kaunelis and Smith39) were each represented by one document. North America alone was represented by two documents (Reference Majid and Vanstone40;Reference Santesso, Lytvyn, Graham, Cowl and Knaapen41).

Almost half of the documents were published as “guides” representing 45 percent (n = 14). Articles (series) (Reference Downe, Finlayson, Lawrie, Lewin, Glenton, Rosenbaum, Barreix and Tunçalp42Reference Lewin, Glenton, Lawrie, Downe, Finlayson, Rosenbaum, Barreix and Tunçalp44) and reviews (Reference Campbell, Weeks, Booth, Kaunelis and Smith39;Reference Majid and Vanstone40;Reference Booth, Lewin, Claire, Munthe-Kaas, Toews and Noyes45;Reference Carmona, Baxter and Carroll46) were represented by four publications each. We also found two book chapters (Reference Booth, Facey, Ploug Hansen and Single47;Reference Steigenberger, Schnell-Inderst, Siebert, Kohlhammer, Schildmann, Buch and Zerth48), and four methodological documents (Reference Booth2;27, Reference Ring, Jepson and Ritchie49;50). One document was titled a manual and the other an article (not a series) (9;Reference Barreto and Lewin38).

The data on the authors’ origins demonstrated that HTA agencies and universities are the places with the highest concentration, with 10 (33 percent) and nine (30 percent) documents, respectively. Universities in the United Kingdom and Canada were responsible for most of the publications. Nine documents were produced by two or more institutions (e.g. Research Institute and Foundation). (Reference Lewin, Glenton, Munthe-Kaas, Carlsen, Colvin and Gülmezoglu20;Reference Lockwood, Munn and Porritt21;Reference Pollock, Peters and Khalil37;Reference Barreto and Lewin38;Reference Santesso, Lytvyn, Graham, Cowl and Knaapen41Reference Glenton, Lewin, Lawrie, Barreix, Downe, Finlayson, Tamrat, Rosenbaum and Tunçalp43;Reference Booth, Lewin, Claire, Munthe-Kaas, Toews and Noyes45;Reference Carmona, Baxter and Carroll46). Four documents were published by organizations such as the WHO (55;Reference Ring, Ritchie, Mandava and Jepson59), the United Kingdom’s National Health Service (NHS) (Reference Booth, Noyes, Flemming, Gerhardus, Wahlster, Van der wilt, Mozygemba, Refolo, Sacchini, Tummers and Rehfuess58), and NHS Scotland (Reference Langlois, Daniels and Akl56).

Notably 22 (71percent) documents were not produced by the HTA agencies. Among those produced by agencies are the NICE, England (Reference Carroll7;Reference Booth, Facey, Ploug Hansen and Single47Reference Ring, Jepson and Ritchie49), Scottish Medicines Consortium (SMC) (52), Pharmaceutical Benefits Advisory Committee (PBAC - Australia) (53), Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) (54), and Institute for Quality and Efficiency in Health Care (IQWIG - Germany) (27).

The publication year of the documents was also mapped, showing an increase in publications in 2018, represented by seven documents, accounting for 23 percent. Eleven documents were published before 2018 (2011–2017), and 13 were published after 2018 (2019–2022). Documents published in 2010 or earlier were not identified.

Specific data

The specific data addressed the second question of the mapping, “What methodological processes are proposed for synthesizing qualitative evidence within an HTA process (e.g., objective, review question, synthesis process, data quality assessment, evidence grading, and form of presentation and incorporation of data in the HTA report)?

The data presented in Table 2 address the rationale for including qualitative data, as well as proposals for structure, methods, tools, or specific instruments for using this type of data in the field of HTA.

Table 2. Specific data according to the concept, objective to include qualitative data, tools, framework, instrument, and checklist

Abbreviations: NI – Not informed, NA – Not applicable

The Qualitative evidence synthesis was defined by most authors as a method to integrate findings from qualitative in dividual studies/research, such as views, beliefs, experiences, and people’s perspectives.

We found that the most common justification for using qualitative data in HTA, independent of the author’s origin, incorporate information about patients’ or other stakeholders’ perspectives to identify acceptability, feasibility, and equity aspects.

The mapping identified several stages related to the synthesis of qualitative evidence: an acronym to guide the research question, instruments for assessing the quality of studies, methods for synthesizing evidence, instruments to guide study writing, a tool to assist in the decision-making of suitable methods for evidence synthesis, and a tool to assign a quality level to the evidence. Although information is available for all these stages, the analysis revealed that not all documents address every stage of the process; several documents present only one stage.

In the research question framework, SPICE was the most frequently endorsed strategy (Reference Glenton, Lewin, Lawrie, Barreix, Downe, Finlayson, Tamrat, Rosenbaum and Tunçalp43;5254). RETREAT was the most cited framework for defining a method for synthesizing qualitative evidence (55;Reference Downe, Finlayson, Lawrie, Lewin, Glenton, Rosenbaum, Barreix and Tunçalp42Reference Lewin, Glenton, Lawrie, Downe, Finlayson, Rosenbaum, Barreix and Tunçalp44). Thematic synthesis was used to synthesize evidence cited more times (Reference Carroll7;Reference Levac, Colquhoun and O’Brien36;Reference Barreto and Lewin38;53;54;Reference Booth, Lewin, Claire, Munthe-Kaas, Toews and Noyes45Reference Steigenberger, Schnell-Inderst, Siebert, Kohlhammer, Schildmann, Buch and Zerth48;Reference Langlois, Daniels and Akl56;57). The most cited instrument for assessing quality was CASP (Critical Appraisal Skills Program) (Reference O’Rourke, Oortwijn and Schuller1;Reference Germeni and Szabo24;Reference Glenton, Lewin, Lawrie, Barreix, Downe, Finlayson, Tamrat, Rosenbaum and Tunçalp43;Reference Barreto and Lewin38;Reference Campbell, Weeks, Booth, Kaunelis and Smith39;Reference Santesso, Lytvyn, Graham, Cowl and Knaapen41;54;Reference Langlois, Daniels and Akl56;57). GRADE- CERQual was the main tool was to grade the quality of evidence (Reference O’Rourke, Oortwijn and Schuller1;Reference Booth, Noyes, Flemming, Gerhardus, Wahlster, van der Wilt, Mozygemba, Refolo, Sacchini, Tummers and Rehfuess18;Reference Lewin, Booth, Glenton, Munthe-Kaas, Rashidian and Wainwright19;Reference Germeni and Szabo24;Reference Page, McKenzie, Bossuyt, Boutron, Goffmann and Mulrow35;Reference Barreto and Lewin38Reference Santesso, Lytvyn, Graham, Cowl and Knaapen41;Reference Glenton, Lewin, Lawrie, Barreix, Downe, Finlayson, Tamrat, Rosenbaum and Tunçalp43;53;57). Enhancing Transparency in Reporting the synthesis of Qualitative research (ENTREQ) was a framework for reporting qualitative research cited with more frequence (Reference Glenton, Lewin, Lawrie, Barreix, Downe, Finlayson, Tamrat, Rosenbaum and Tunçalp43;57). In the topic recommendation, the GRADE evidence-to-decision (EtD) framework was a unique tool cited by five documents (Reference Campbell, Weeks, Booth, Kaunelis and Smith39Reference Santesso, Lytvyn, Graham, Cowl and Knaapen41;Reference Glenton, Lewin, Lawrie, Barreix, Downe, Finlayson, Tamrat, Rosenbaum and Tunçalp43;53).

The compilation of the strategies informed by the documents according to the steps for conducting a synthesis of qualitative evidence is described in Table 3.

Table 3. Compilation of the strategies informed according to each step of the qualitative evidence synthesis process

Discussion

According to our findings, some HTA agencies with more experience in the field (e.g., NICE, SMC, and SBU) include statements in their documents/guides related to the importance of considering qualitative data in the HTA process. However, an explanation of how to conduct the process was found only in three documents published by HTA agencies from Sweden, Scotland, and Germany (Reference Germeni and Szabo24;52;54).

The adoption of health technology assessments has grown in significance as countries allocate limited resources to maximizing patient health benefits (Reference Booth, Noyes, Flemming, Gerhardus, Wahlster, Van der wilt, Mozygemba, Refolo, Sacchini, Tummers and Rehfuess58).

Historically, more attention was given to costs and effectiveness as criteria for recommending technologies rather than social or ethical consequences or questions of acceptance (Reference Leys62).

Nevertheless, informed decisions require an interdisciplinary nature of HTA processes (54). From this perspective, the inclusion of qualitative data in HTA processes not only endorses the interdisciplinary nature of HTA analyses but also broadens the scope of health information that supports decision-making in determining evidence-based healthcare.

However, according to Germeni and Szabo (Reference Munn, Porritt, Lockwood and Person23), the integration of qualitative methodologies must align with established quality and reporting standards, concentrating on domains in which they can effectively illuminate issues that quantitative methods may not adequately capture. This ensures the realization of the full potential. They contend that fostering methodological innovation in the application of swift qualitative techniques and devising new strategies to leverage the synergy between qualitative and quantitative data in mixed methods research would greatly enhance the future of the HTA field. Regardless of the present mapping, researchers and HTA agencies have proposed methodological alternative frameworks, tools, and checklists to standardize the process.

Staniszewska et al. (Reference Booth, Lewin, Claire, Munthe-Kaas, Toews and Noyes45) highlighted that HTA agencies have made progress by including patient evidence in their assessments. For example, the authors mentioned the SBU, and its Handbook of Assessment of Methods in Health Care and Social Services, which includes chapters on patient-based evidence and the evaluation and synthesis of studies using qualitative methods. Only these two documents organize and present steps with specific methods, as a guide, while most of the documents analyzed in this review present separate suggestions for acronyms, frameworks, methods of synthesizing evidence, instruments to assess quality, tools to grade the quality of evidence, frameworks for reporting qualitative research, and recommendations.

Most findings of this review are similar to those of Sousa et al. (Reference Sousa, Wainwright and Soares63) who published an introductory paper on qualitative evidence synthesis methodologies. The tools identified in this review were the Retreat framework, SPIDER, SPICE, and PerSPEcTiF. To describe the level of confidence in the evidence produced by a synthesis, GRADE CerQual was cited. Sousa et al. (Reference Sousa, Wainwright and Soares63) reported similar tools for qualitative synthesis, such as ENTREQ and eMERGe (60).

Considering the reasons for incorporating qualitative data into HTA reports, the presented mapping of the most common justification was the patients’ or other stakeholders’ opinions and experiences to primarily identify aspects related to acceptability, feasibility, and equity. This finding is in accordance with that of Leys (Reference Ring, Ritchie, Mandava and Jepson59), who found that qualitative research can contribute to the HTA process by offering the perspectives, meanings, values, and interests of different stakeholders regarding technology. This reinforces the fact that qualitative research directs its attention to the social realm, equipping investigators with the means to explore health phenomena through the lenses of those who directly encounter them (Reference Khankeh, Ranjbar, Khorasani-Zavareh, Zargham-Boroujeni and Johansson64).

The structuring and standardization of processes can provide information to support decision-making by incorporating qualitative evidence into the HTA process and improving the quality of recommendations, providing evidence of feasibility, appropriateness, and significance, as well as patient values and preferences, acceptability, and equity. In addition, it can reduce methodological variations by allowing standardization of the process, making it easier to compare across different contexts while respecting the principles of transferability and equity.

Strengths and limitations

This review was limited to discussing the frameworks for including the qualitative evidence in the HTA process; potentially missing are qualitative evidence synthesis methods that were not developed specifically or described in this context.

This mapping demonstrated that the field of HTA has expanded the way technologies are assessed, and HTA agencies have include frameworks to guide the inclusion of qualitative evidence. However, another important limitation is that this review did not analyze the reports from different agencies to identify the practical application of these tools/instruments (process and results).

Implications for research

In light of this review, it may be relevant to conduct a qualitative study involving stakeholders (health technology practitioners, industry representatives, decision-makers, health technology researchers, qualitative data experts, qualitative evidence synthesis specialists, patients, and family representatives) to identify barriers and facilitators to implementing and analyzing qualitative evidence in the process of HTA.

Implications for practice

The findings of this mapping identified guidelines or frameworks for synthesizing qualitative evidence for use in HTA. This result can offer practitioners the option of including qualitative evidence synthesis to obtain opinions, experiences, patient-centered approaches, and social perspectives in the HTA process. This implies development of an HTA that includes evidence of feasibility, acceptability, and new outcomes for health services that can influence interventions on equity and human rights.

Conclusions

This review, which mapped and described the frameworks, tools, and processes used to include, synthesize, and evaluate the quality of qualitative evidence in the HTA context showed that SPICE was the most cited acronym and RETREAT was the preferred framework for synthesizing qualitative evidence. Thematic synthesis was the most frequently cited method for evidence synthesis and CASP was the most frequently mentioned instrument for quality assessment. The GRADE-CERQual was the primary tool for grading evidence quality, and ENTREQ was the most cited framework for reporting qualitative research synthesis.

This review confirmed the recent trend of including qualitative evidence in HTA documents. Although the documents cited common instruments, methods, or tools, they had different proposals, and only a few documents encompassed all the necessary steps in the process.

The implementation of a proposal to incorporate qualitative data into HTA processes requires strategies for the entire process, starting with identifying and characterizing the audience that will use the information, defining how to convey knowledge and guidance, anddefining the requirements and competencies required to incorporate, analyze, and synthesize qualitative data to support decision-making in the field of healthcare.

Supplementary material

The supplementary material for this article can be found at http://doi.org/10.1017/S0266462324000369.

Author contribution

MMAC, RTM: Conceptualisation, Methodology, Investigation, Data Curation, Formal Analysis, Writing – Original Draft, Review and Editing, Project Administration; LT, MV: Conceptualisation, Methodology, Writing – Review and Editing, Supervision; JMR, VAAP, SATW: Conceptualisation, Writing - Review and Editing; GPND, RTA, CCP, LCL, MG, SD, CMAR: Discussion, Writing – Original Draft, Review and Editing.

Funding statement

This review receives partial funding from Roche Chemical and Pharmaceutical Products S.A.

Competing interest

The authors declare no conflict of interest.

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Figure 0

Figure 1. Document selection process, stages of title and summary reading, and full reading.

Figure 1

Table 1. Characteristics of the document based on the region, HTA agency, document type, and author’s context

Figure 2

Figure 2. Characterization of the documents.

Figure 3

Table 2. Specific data according to the concept, objective to include qualitative data, tools, framework, instrument, and checklist

Figure 4

Table 3. Compilation of the strategies informed according to each step of the qualitative evidence synthesis process

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