Shingai Machingaidze

Guide to Clinical Practice Guidelines: The Current State of Play

Abstract Introduction Extensive research has been undertaken over the last 30 years on the methods underpinning clinical practice guidelines (CPGs), including their development, updating, reporting, tailoring for specific purposes, implementation and evaluation. This has resulted in an increasing number of terms, tools and acronyms. Over time, CPGs have shifted from opinion-based to evidence-informed, including increasingly sophisticated methodologies and implementation strategies, and thus keeping abreast of evolution in this field of research can be challenging. Methods This article collates findings from an extensive document search, to provide a guide describing standards, methods and systems reported in the current CPG methodology and implementation literature. This guide is targeted at those working in health care quality and safety and responsible for either commissioning, researching or delivering health care. It is presented in a way that can be updated as the field expands. Conclusion CPG development and implementation have attracted the most international interest and activity, whilst CPG updating, adopting (with or without contextualization), adapting and impact evaluation are less well addressed.

To adopt, to adapt, or to contextualise? The big question in clinical practice guideline development

AimDeveloping new clinical practice guidelines (CPGs) can be time-consuming and expensive. A more efficient approach could be to adopt, adapt or contextualise recommendations from existing good quality CPGs so that the resultant guidance is tailored to the local context.ResultsThe first steps are to search for international CPGs that have a similar purpose, end-users and patients to your situation. The second step is to critically appraise the methodological quality of the CPGs to ensure that your guidance is based on credible evidence. Then the decisions begin. Can you simply ‘adopt’ this (parent) clinical practice guidelines, and implement the recommendations in their entirety, without any changes, in your setting? If so, then no further work is required. However this situation is rare. What is more likely, is that even if recommendations from the parent clinical practice guidelines can be adopted, how they are implemented needs to address local issues. Thus you may need to ‘contextualise’ the guidance, by addressing implementation issues such as local workforce, training, health systems, equipment and/or access to services. Generally this means that additional information is required (Practice/Context Points) to support effective implementation of the clinical practice guidelines recommendations. In some cases, you may need to ‘adapt’ the guidance, where you will make changes to the recommendations so that care is relevant to your local environments. This may involve additional work to search for local research, or obtain local consensus, regarding how best to adapt recommendations. For example, adaptation might reflect substituting one drug for another (drugs have similar effects, but the alternative drug to the recommended one may be cheaper, more easily obtained or more culturally acceptable). There is lack of standardisation of clinical practice guidelines terminology, leading clinical practice guideline activities often being poorly conceptualised or reported. We provide an approach that would help improve efficiency and standardisation of clinical practice guidelines activities.

Series: Clinical Epidemiology in South Africa. Paper 2: Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Mapping South African allied health primary care clinical guideline activity: establishing a stakeholder reference sample

BackgroundLittle is known about allied health (AH) clinical practice guideline (CPG) activity in South Africa, and particularly in relation to primary health care (PHC). This paper reports on a scoping study undertaken to establish a reference framework, from which a comprehensive maximum variation sample could be selected. This was required to underpin robust sampling for a qualitative study aimed at understanding South African primary care AH therapy CPG activities. This paper builds on findings from the South African Guidelines Evaluation (Project SAGE) Flagship grant.MethodsSouth African government websites were searched for structures of departments and portfolios, and available CPGs. Professional AH association websites were searched for CPGs, purposively-identified key informants were interviewed, and CPGs previously identified for priority South African primary care conditions were critiqued for AH therapy involvement.ResultsKey informants described potentially complex relationships between players who may be engaged in South African AH CPGs, in both public and private sectors. There were disability/rehabilitation portfolios at national and provincial governments, but no uniformity in provincial government organisation of, or support for, PHC AH services. There were no AH primary care therapy CPGs on government websites, although there was ‘clinical guidance’ in various forms on professional association websites. Only two CPGs of priority South African PHC conditions included mention of any AH therapy (physiotherapy for adult asthma and chronic obstructive pulmonary disease).ConclusionA comprehensive and wide-reaching stakeholder reference framework would be required in order to capture the heterogeneity of AH primary care CPG activity in South Africa. This should involve the voices of national and purposively-selected provincial governments, academic institutions, consultants, public sector managers and clinicians, private practitioners, professional associations, and private sector insurers. Provincial governments should be selected to reflect heterogeneity in local economics, population demographics and availability of university AH training programs. This investigation should aim to determine the areas of PHC in which AH are engaged.

Next generation clinical guidance for primary care in South Africa – credible, consistent and pragmatic

Background Agreed international development standards underpin high quality de novo clinical practice guidelines (CPGs). There is however, no international consensus on how high quality CPGs should ‘look’; or on whether high quality CPGs from one country can be viably implemented elsewhere. Writing de novo CPGs is generally resource-intensive and expensive, making this challenging in resource-poor environments. This paper proposes an alternative, efficient method of producing high quality CPGs in such circumstances, using existing CPGs layered by local knowledge, contexts and products. Methods We undertook a mixed methods case study in South African (SA) primary healthcare (PHC), building on findings from four independent studies. These comprised an overview of international CPG activities; a rapid literature review on international CPG development practices; critical appraisal of 16 purposively-sampled SA PHC CPGs; and additional interrogation of these CPGs regarding how, why and for whom, they had been produced, and how they ‘looked’. Results Despite a common aim to improve SA PHC healthcare practices, the included CPGs had different, unclear and inconsistent production processes, terminology and evidence presentation styles. None aligned with international quality standards. However many included innovative succinct guidance for end-users (which we classified as evidence-based summary recommendations, patient management tools or protocols). We developed a three-tiered model, a checklist and a glossary of common terms, for more efficient future production of better quality, contextually-relevant, locally-implementable SA PHC CPGs. Tier 1 involves transparent synthesis of existing high quality CPG recommendations; Tier 2 reflects local expertise to layer Tier 1 evidence with local contexts; and Tier 3 comprises tailored locally-relevant end-user guidance. Conclusion Our model could be relevant for any resource-poor environment. It should reduce effort and costs in finding and synthesising available research evidence, whilst efficiently focusing scant resources on contextually-relevant evidence-based guidance, and implementation.

Barriers and enablers for the development and implementation of allied health clinical practice guidelines in South African primary healthcare settings : a qualitative study

BackgroundThe South African allied health (AH) primary healthcare (PHC) workforce is challenged with the complex rehabilitation needs of escalating patient numbers. The application of evidence-based care using clinical practice guidelines (CPGs) is one way to make efficient and effective use of resources. Although CPGs are common for AH in high-income countries, there is limited understanding of how to do this in low- to middle-income countries. This paper describes barriers and enablers for AH CPG uptake in South African PHC.MethodsSemi-structured individual interviews were undertaken with 25 South African AH managers, policymakers, clinicians and academics to explore perspectives on CPGs. Interviews were conducted by researcher dyads, one being familiar with South African AH PHC practice and the other with CPG expertise. Rigour and transparency of data collection was ensured. Interview transcripts were analysed by structuring content into codes, categories and themes. Exemplar quotations were extracted to support themes.ResultsCPGs were generally perceived to be relevant to assist AH providers to address the challenges of consistently providing evidence-based care in South African PHC settings. CPGs were considered to be tools for managing clinical, social and economic complexities of AH PHC practice, particularly if CPG recommendations were contextusalised. CPG uptake was one way to deal with increasing pressures to make efficient use of scarce financial resources, and to demonstrate professional legitimacy. Themes comprised organisational infrastructures and capacities for CPG uptake, interactions between AH actors and interaction with broader political structures, the nature of AH evidence in CPGs, and effectively implementing CPGs into practice.ConclusionCPGs contextualised to local circumstances offer South African PHC AH services with an efficient vehicle for putting evidence into practice. There are challenges to doing this, related to local barriers such as geography, AH training, workforce availability, scarce resources, an escalating number of patients requiring complex rehabilitation, and local knowledge. Concerted attempts to implement locally relevant CPGs for AH primary care in South Africa are required to improve widespread commitment to evidence-based care, as well as to plan efficient and effective service delivery models.

South African primary health care allied health clinical practice guidelines: the big picture

BackgroundGood quality clinical practice guidelines (CPGs) are a vehicle to implementing evidence into allied health (AH) care. This paper reports on the current ‘state of play’ of CPGs in a lower-to-middle-income country (South Africa), where primary healthcare (PHC) AH activities face significant challenges in terms of ensuring quality service delivery in the face of huge PHC need.MethodsA qualitative study was conducted, using semi-structured interviews with purposively-sampled individuals involved in AH PHC CPGs in South Africa. They included national and state government policy-makers, academics and educators, service managers, clinicians, representatives of professional associations, technical writers, and members of informal professional networks. The interview data was transcribed and de-identified, and analysed descriptively by hand-coding. The COREQ statement guided study conduct and reporting. A framework to guide research in other countries into perspectives of AH PHC CPG activities was established.ResultsOf the 32 invited, 29 people participated: of these 25 were interviewed and four provided meeting notes. Most participants had multiple professional roles, being engaged concurrently in clinical practice, academia, professional associations and / or government. Key themes comprised Players (sub-themes of sampling frame, participants, advice, role players and collaboration); Guidance (sub-themes of nomenclature, drivers, purpose, evidence sources) and Role of AH in PHC (sub-themes of discipline groupings, disability and rehabilitation, AH recognition).ConclusionThere was consistently-expressed desire for quality guidance to support better quality AH PHC activities around the country. However no international CPGs were used, and there were no South African CPGs specific to local PHC AH practice. The guidance gap was filled by non-evidence-based documents produced often without training, to deal with specific clinical situations. This led to frustration, duplication and fragmentation of effort, confusing nomenclature, and an urgent need for standardised and agreed guidance. We provided a standardised framework to capture perspectives on CPGs activities in other AH PHC settings.

Building capacity in primary care rehabilitation clinical practice guidelines: a South African initiative

BackgroundThe large number of South Africans with disability who cannot access good quality rehabilitation presents a public health and human rights challenge. A cost-effective, efficient approach is required to address this. Implementation of high-quality, contextually relevant clinical practice guidelines (CPGs) could be a solution; however, this requires significant investment in innovative capacity-building.MethodsA qualitative descriptive national study was conducted to explore the perspectives of South African stakeholders in rehabilitation, regarding CPG capacity-building. Twenty rehabilitation professionals (physiotherapists, occupational therapists, speech language therapists, podiatrists, rehabilitation managers or directors) were interviewed. Transcribed interview data were analysed using a deductive content analysis approach, mapping findings to an international capacity-building framework to produce new knowledge.ResultsCapacity-building is required in content, purpose and construction of locally relevant CPGs, as well as personal, workforce and systems capacity. Principles and strategies were derived to underpin implementation of CPGs that are user friendly, context specific, relevant to the needs of end-users, and achievable within available resources. Collaboration, networks and communication are required at national, provincial and regional level, within and between sectors. A central agency for CPG methods, writing, implementation and evaluation is indicated.ConclusionSouth African rehabilitation can benefit from a multi-level CPG capacity-building focusing on performance, personal, workforce and systems issues.

Original ArticleSeries: Clinical Epidemiology in South Africa. Paper 2: Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.