Article Text

Systematic literature review of the barriers and facilitators of frugal innovation for surgical care in low-income and middle-income countries
  1. Cyan Brittany Brown1,2,
  2. Lisa McDermott3
  1. 1 Stanford Biodesign, Stanford University, Palo Alto, CA, USA
  2. 2 Faculty of Life and Medical Sciences, School of Population Health & Environmental Sciences, King's College London, London, UK
  3. 3 Public Health in the School of Population Health & Environmental Sciences, King's College London, London, UK
  1. Correspondence to Dr Cyan Brittany Brown, Stanford Biodesign, Stanford University, Palo Alto, California, USA; c.brown{at}atlanticfellows.org

Abstract

Objective Globally, 5 billion people lack access to safe surgery and annually, only 6% of surgeries occur in low-income countries. Surgical frugal innovations can reduce cost and optimise the function for the context; however, there is limited evidence about what enables success.

Design A systematic literature review (SLR) was performed to understand the barriers and facilitators of frugal innovation for surgical care in low-income and middle-income countries (LMICs).

Data sources Web of Science, PubMed, Embase at Ovid, Google Scholar and EThOs were searched.

Eligibility criteria for selecting studies Inclusion criteria were original research in English containing a frugal surgical innovation. Research must be focused on LMICs. Studies were excluded if the content was not focused on LMICs or did not pertain to barriers and facilitators. 26 studies from 2006 to 2021 were included. The GRADE tool was used to assess overall review quality.

Results Results were analysed using the modified consolidated framework for implementation research. The lack of formal evidence regarding frugal innovation in LMICs was the most reported barrier. The adaptability of frugal innovations to the context was the most reported facilitator. The limitations of this study were that most frugal innovations are not included in formal literature and that only English studies were included.

Conclusion Frugal surgical innovations that are highly adaptable to the local context hold significant potential to scale and positively affect healthcare access and outcomes. Furthermore, supporting formal research about frugal innovations is important when aiming to innovate for health equity.

  • Global Health
  • Surgical Procedures, Operative
  • Public Health

Data availability statement

Data is available in the OSF data repository and can be accessed here: https://osf.io/t75na/?view_only=8959863c020f41778f0b2734e914c651.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

WHAT IS ALREADY KNOWN ON THIS TOPIC

  • The potential for frugal innovation to increase access to surgical care has been established for certain surgical frugal innovations. What is not known is why some frugal innovations succeed and others fail.

WHAT THIS STUDY ADDS

  • This study adds the first synthesis of barriers and facilitators of frugal innovations in low-income and middle-income countries for surgical care within an implementation science framework.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

  • The findings of this review illustrate key barriers and facilitators for surgical frugal innovation for practitioners and academics. Furthermore, this review indicates that more research on this topic is needed to help translate current innovation practice.

Introduction

Limited access to safe surgical care is a considerable global health problem. It is estimated that 11%–15% of the world’s disability is attributable to surgically treatable diseases.1 Furthermore, this burden is inequitably distributed, as the poorest third of the world’s population receives only 3.5% of the 250 million annual surgeries.2Evidence suggests that surgery is a cost-effective public health intervention that needs greater prioritisation to address this inequitable access.3

Another significant challenge for healthcare systems globally is to control escalating healthcare costs while improving quality and access.4 Evidence suggests that frugal innovation is one option to reduce costs and increase access to surgical care, especially in low-income and middle-income countries (LMICs).5 Frugal innovations are defined as providing contextually appropriate, low-cost and durable innovations that can increase access to surgical care without compromising safety.6

There is evidence of frugal innovations positively impacting surgical care in LMICs.7 However, critical appraisal of existing evidence revealed a lack of understanding about why specific innovations succeed and others fail.8 There is no known SLR to date on the barriers and facilitators of frugal innovations for surgical care in LMICs.9 This synthesis may assist stakeholders in global health to further leverage the potential of frugal innovations to increase access to surgical care in LMICs.10

Methods

Search terms are listed in table 1. Search terms were derived from key articles on the topic and through consultation with a King’s College London (KCL) librarian. Three databases were used: PubMed, Embase Ovid and Web of Science. The search strategy was reviewed by an information specialist from KCL and on the university SLR forum. It was also discussed with an author in the field.11 Beyond the databases above, grey literature was searched as many frugal innovations are not found in traditional databases.12 The protocol listed the Open Grey Database and the Healthcare Management Information Consortium; however, these returned no results. After consultation with a KCL librarian, Google scholar and EThOS were selected.

Table 1

Search terms

The Preferred Items for Reporting Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist guideline was used to inform the methods.13 This review was not registered. Studies were included if they were original research and focused on a frugal surgical innovation that benefitted an LMIC. LMICs were defined using the World Bank criteria.14 Given the complexity of definitions and poor indexing of frugal innovation, an empirically derived frugal innovation identification tool developed by a prominent author in the field was used to determine if studies met the frugal innovation inclusion criteria.15

Studies were not restricted to those whose main objective was an assessment of the barriers and facilitators, as data were analysed for information that could be a barrier or facilitator, even if it was not labelled as such. No study design was excluded, but the limit of the English language was applied. Studies were excluded if the barriers and facilitators identified were too case specific or too vague for generalisation in the broader LMIC context.

The main author, CBB, screened and did the full-text review, data extraction and study quality assessment individually. The search was conducted between June and November 2021. All citations identified in the search were imported into the Mendeley database, and duplicate records were removed.16 The titles and abstracts of all articles returned from the search were screened. Eligible articles were full-text screened based on the inclusion criteria checklist listed in box 1. Handsearching was done of all included studies’ reference lists.

Box 1

Full-text inclusion checklist

  • Studies comprise original data collection.

  • Studies are in English.

  • Studies are focused on low-income and middle-income country (LMIC) as defined by the World Bank LMIC criteria.14 Research may be conducted anywhere; however, the focus should be on the frugal innovation impact in LMICs.

  • Surgical care is defined as the provision of operative, perioperative and non-operative management, anaesthesia and obstetric care for all surgical conditions.30

  • Access to surgical care is defined as the existence of trained staff, infrastructure and the ability to obtain surgical care in a timely, safe and affordable way.30

  • Studies should contain a frugal innovation as defined by Prime.5 All three criteria need to be met to qualify as a frugal innovation.15

    • Affordability

      • Is the product or service more affordable to generate or operate than alternatives?

    • Adaptability

      • Is it adapted to the needs of the context to better perform or be good enough?

    • Accessibility

      • Is it accessible to and scalable to benefit many in society?

Data were extracted using Microsoft Excel.17 The author extracted and coded data for each study based on the headings in table 2. Included studies were descriptively analysed as the nature of barriers and facilitators is qualitative. Data were then organised into results in table 3 featured in the results section, structured according to the modified Consolidation Framework for Implementation Research (mCFIR). Data that did not fit into the mCFIR were listed under a new construct in the results. Subgroup analysis was done according to the dominant categories to explore possible causes of heterogeneity.

Table 2

Summary of the characteristics of included studies

Table 3

Results analysed in the mCFIR framework

Systematic literature reviews (SLR) may further the impact of research that is not ethically sound or of sufficient quality if these are not explicit criteria in the research process.18 Therefore, the Cochrane guidelines were used in this SLR to ensure ethical conduct and quality reporting.19 Table 4 in online supplemental material reflects the evaluation of each article for publication bias, indirectness, inconsistency, imprecision and risk of bias. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool was used to rate the overall quality of evidence of the review. While GRADE is a validated tool that can provide a reproducible and transparent framework for grading certainty in evidence, it remains overall subjective.20

Supplemental material

While ethical approval was not required for this review, ethical reflexivity was considered throughout the process. For ethical reflexivity, the discussion of results of frugal surgical innovation in LMICs was located within the broader socio-political context in which they occurred to avoid reductionist understandings of the topic that may be harmful. 21 22 Equity was also an ethical consideration that informed the choice to focus on LMICs, given the inequitable access to surgical care19

Results

The PRISMA flow chart in figure 1 illustrates the process of identifying eligible studies.

Figure 1

PRISMA flow chart of the systematic literature review search process. LMIC: low-income and middle-income country; PRISMA: Preferred Items for Reporting Systematic Reviews and Meta-Analyses.

The initial search retrieved 1789 studies, and after removing 287 duplicates, the total was 1502 results. After screening the titles and abstracts, 1371 articles were removed. A total of 131 studies were downloaded, and the full text was screened according to the inclusion criteria checklist. Twenty-eight English studies were included in the final selection for data extraction. Two studies were removed during this stage due to barriers and facilitators being too vague to apply to a general LMIC context. Twenty-six studies were included from 2006 to 2021. Table 2 contains the details of the included studies. Most of the studies focused on India (10), followed by Africa (7) as indicated in figure 2. Thirteen studies focused on frugal products, and 12 focused on frugal policies and processes. Six of the studies focused specifically on the surgical safety checklist (SSC). The most common methodology was qualitative case studies (12).

Figure 2

Geographical clusters of included studies.

Using a conceptual framework based on theory is an important tool for enriching the quality of research by making the processes explicit.23 24 The mCFIR was selected as the most appropriate framework for this study as it has been extensively validated in health innovation implementation, including frugal surgical innovations.11 25 Furthermore, it has also been shown to be suitable for complex global health topics.26 The mCFIR chosen is based on the CFIR. The CFIR was developed by consolidating 19 existing implementation science frameworks. It is a pragmatic, meta-theoretical framework consisting of five core domains containing specific constructs (subcategories) seen in table 3. The domains are ‘inner setting’, ‘outer setting’, ‘intervention characteristics’, ‘implementation processes’ and ‘individuals’.25

However, existing literature proposes that context is an essential mediator in health innovation implementation.27 Therefore, Means et al empirically developed the mCFIR specifically for the LMIC context through the addition of a domain called ‘characteristics of systems’ and 11 novel constructs to the CFIR.28 Given the LMIC focus of this SLR, the mCFIR was used. The adaptability of the mCFIR for the LMIC context and its extensive previous validation in global health innovation makes it ideal to use in this review.11 Results are organised according to the mCFIR in table 3. In the results, only one thematic area, namely, ‘innovation framing’, was not captured in the existing mCFIR framework. Thus, expanding the framework was proposed through the addition of a new construct. Overall, the mCFIR provided a practical way to organise data and account for complexity while eliciting the mega themes.28 The emergent results in table 3 were largely congruent with the mCFIR. Only one thematic area in the results did not fit into the existing framework. Therefore, a new construct called ‘innovation framing’ was proposed to expand the mCFIR for frugal surgical innovation based on the evidence of this SLR.

In table 3, ‘the intervention’ (domain 1) was the most saturated with data. It contained the barrier and facilitator that were most commonly reported. The most prevalent barrier identified was in the ‘evidence strength and quality‘ construct. Thirteen studies stated that a lack of formal evidence regarding frugal innovations and the diffusion thereof specifically in LMICs was a significant barrier. The construct that was the most commonly reported facilitator was ‘adaptability’. Twelve studies cited that the more adaptable a frugal surgical innovation was to the local context, the easier it was to implement.

Additionally, in the ‘intervention’ domain, the construct of ‘cost’ was both a barrier and a facilitator. 6 studies cited the high initial cost of investment to develop frugal innovations as a barrier. Furthermore, six studies cited the low-cost characteristic of frugal innovations for the patients as a facilitator, as it meant that most of the population could afford it. These domain scores can be seen in figure 3.

Figure 3

Most common barriers and facilitators illustrating the most saturated constructs in domains 1 and 3. mCFIR: modified Consolidation Framework for Implementation Research.Green= facilitators and red = barriers.

Domain 3, the ‘outer setting’, was the second most populated. The construct of ‘structural characteristics’ contained six studies that cited the lack of regulatory approval of frugal innovations as a major barrier, as this discouraged geographical expansion. The construct of ‘implementation climate’ had 10 studies that evidenced infrastructural and institutional barriers as important as these limitations prohibited expanding partnerships.

Subgroup analysis was done between the major categories, including India and Africa, frugal products and processes and dominant innovations, including the SSC and Aravind and Narayana hospitals. The six SSC studies emphasised the ‘team characteristics’ domain more than other studies. The four studies focused on Aravind and Narayana hospitals emphasised the ‘systems architecture’ construct with ‘economies of scale’ and ‘lean management’ listed as critical facilitators to their frugal approach. The GRADE scoring for the overall review was moderate, as publication bias and risk of bias were a concern given the poor indexing of the field, however, the effect is still deemed probably close to the true effect for answering the overall question.20

Discussion

Despite the progress made in global health in the last 25 years, in many LMICs, access to safe surgical care has stagnated or regressed.29 Consequentially, 16.9 million lives were lost in 2010 due to inadequate access to surgical care, representing 32.9% of all deaths globally. Furthermore, 94% of the population in LMICs do not have access to safe surgical care, compared with only 14.9% in high-income countries.30

In global health, a better understanding of the factors that hinder or facilitate frugal innovation in surgical care in LMICs can aid the development and diffusion of more effective frugal innovations in surgical care.31 This is important because frugal innovation may offer a cost-effective option to bridge the current gap in access to surgical care.32 Thus, this review can potentially contribute to developing more effective frugal innovations in surgical care for LMICs in the future.33 However, these findings only represent partial explanations about the complex nature of implementing frugal surgical innovations and must be considered helpful but incomplete understandings of the topic as they cannot be generalised in every LMIC setting.34 To avoid reductionist understandings, these barriers and facilitators must be examined considering the complexity of the socio-economic, behavioural and political context of the environment in which they function.35 Additionally, innovations are not the only thing necessary to improve access to surgical care, and stakeholders must also address the structural root causes of the lack of surgical care access.36 37

The most reported barrier was the lack of formal evidence about frugal innovation and its diffusion in an LMIC context. Many frugal surgical innovations rely on informal, tacit knowledge, which is difficult to formalise and share.15 38 This barrier may also be partially understood in the context of unequal access to funding and research development for practitioners in global health in LMICs.39 40 This barrier is supported by conclusions of prominent experts in the field who advocate for more formal research on the development and adoption of frugal innovations in surgical care specifically focused on LMICs.8 41 42

The main facilitator in this study was the construct of ‘adaptability’. If frugal innovations are well adapted to the local context while still meeting the minimum performance requirements, it may help facilitate successful implementation.43 This finding highlights existing evidence that asserts the importance of using context-specific adaptation for specific geographies and communities to design and implement successful frugal innovations.44

In practice, applying the main facilitator of ‘adaptability’ of frugal surgical innovations can help prioritise context-specific adaptation into every stage of design and implementation to possibly produce more locally adapted successful innovations.45 If the major barrier of a lack of formal evidence concerning frugal surgical innovations in LMICs can be addressed by encouraging local frugal innovators and the global health research community to produce formal research on this work, it may help grow the evidence base that informs how to develop frugal surgical innovations successfully.46 Additionally, furthering this research aligns with many global health goals to increase surgical care access.47 48 These include the 2030 Sustainable Development Goals 3, 9 and 10 and the Lancet Commission of surgery recommendations.30 49

The strengths of this study are that it included a grey literature review which may enrich the findings through the diversification of sources.50 51 It also used an empirically validated tool to identify frugal innovations and a validated framework adapted for the LMIC context.28 Given the nature of frugal innovation and the focus on LMICs, the English language limitation excluded substantial literature. Frugal innovation is also not a well-indexed field, and studies may have been missed due to different indexing, which is a limitation of this review. This is because, in many countries, frugal innovations are simply seen as effective ways to cope in resource-constrained environments and thus may not be labelled as innovations.15

Conclusion

Lack of access to surgical care is a considerable global health problem. Frugal innovation is a tool that can enable a cost-effective approach to increasing access to surgical care in LMICs.52 The purpose and justification of this review were to address the current evidence gap in understanding what facilitates or hinders frugal innovation implementation in surgical care. The lack of formalised evidence about frugal innovation in surgical care in LMICs was the most prevalent barrier. The adaptability of frugal innovations to the local context was the most prevalent facilitator. It is recommended that formalised research about frugal innovation in surgical care for LMICs becomes a priority for global health so that more cost-effective innovations can address the urgent need for surgical care.30 53

Data availability statement

Data is available in the OSF data repository and can be accessed here: https://osf.io/t75na/?view_only=8959863c020f41778f0b2734e914c651.

Ethics statements

Patient consent for publication

Acknowledgments

I would like to acknowledge Dr Lisa McDermott who was a wonderful mentor, supervisor and source of support during the writing of this review. I would also like to acknowledge Dr Katrin Augustin, Dr Alec Knight, Dr Assaf Givati and Dr Kalwant Sidhu for their contribution to my master's degree in public health and for helping guide me throughout my course.

References

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Footnotes

  • Contributors CBB planned, conducted and reported on the work in the paper. CBB is the gaurantor of this paper. LM helped to conceptualise the paper and assisted with the interpretation and analysis of the data.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.