An innovative method for clinical practice guideline contextualisation for chronic musculoskeletal pain in the South African context

The implementation of clinical practice guidelines (CPGs) is advocated to optimise the quality, consistency, appropriateness and cost-effectiveness of health care [1]. CPGs are described as a set of systematically developed clinical recommendations that assist different stakeholders in making decisions about health care for specific clinical circumstances [2]. Clinical recommendations should be based on best available evidence to inform policy and practice by providing information regarding effectiveness, value and harms of interventions [3]. However, the uptake and effectiveness of CPGs are often questioned. Several studies have found mixed results regarding the ability of CPGs to influence practice patterns, patient outcomes and health system outcomes [4‐7]. Various reasons are offered for the lack of CPG uptake. Kastner et al. [8] mention that implementation strategies for complex interventions, such as CPGs, have focussed on extrinsic factors to change provider behaviour and practice environments, rather than intrinsic guideline characteristics (e.g. clarity, specificity and clinical applicability of recommendations). Improving the applicability of the recommendations for the intended setting by integrating contextual factors during CPG development and implementation is suggested to enhance CPG uptake [7].

CPG contextualisation is a new and innovative approach to develop CPGs and to facilitate uptake in resource-constrained environments. Contextualisation is based on the premise that CPGs produced in developed nations may not be appropriate in resource-constrained environments, due to differences in the healthcare systems, socio-cultural, societal and policy contexts [9, 10]. There are several methods to develop CPGs: they can be written de novo, or existing guidelines can be modified [9‐13]. In alternative CPG development, a guideline can simply be adopted to another application or environment; or they can be adapted (modified) in accordance with varying needs or circumstances. In the literature these processes of adoption and adaptation have primarily been performed in comparable, developed-nation contexts [9, 14]. A hybrid process has emerged from GRADE (Grading of Recommendations Assessment, Development and Evaluation) called Adolopment which combines elements of de novo, adoption and adaptation [12]. To deepen the ability to consider the often profoundly different circumstances of economics, service frameworks and demography of developing countries, the process of contextualisation was created [9]. During contextualisation, recommendations are sourced from existing CPGs, but are tailored to suit the specific needs of the context. A defining feature of the contextualisation process is that existing recommendations are not updated, but are rephrased to be suitable for the intended setting.

This study adds to the body of knowledge for CPG contextualisation by proposing a feasible way to explore and integrate context-related factors into the guideline development process. Context factors represent the typical circumstances into which interventions will be implemented, such as the setting in which people receive healthcare services [15]. Additionally, this study added the integration of multiple stakeholders’ perspectives, as several authors advocate the inclusion of stakeholder values and preferences as part of CPG development. However, the above strategy has not been commonly adopted in CPG development [16, 17]. Our contextualisation approach is different to previous contextualisation approaches [9], as we added a contextual analysis phase and we used consensus methods to endorse recommendations and integrate contextual information. For practical purposes, we explored the concept of CPG contextualisation using the example of chronic musculoskeletal pain (CMSP) in South Africa (SA), an upper-middle-income country with a transforming healthcare system [18, 19].

CMSP, a global healthcare concern, is a major cause of disability and morbidity in sub-Saharan Africa. In SA, musculoskeletal conditions contribute significantly to the years lived with disability (YLD) [20]. However, the current healthcare context of SA is challenged by the country’s quadruple burden of disease which consists of the prevention and management of the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and tuberculosis; chronic non-communicable diseases; maternal and child health; and trauma and violence [19]. Consequently, healthcare resources are channelled towards these priorities, creating a resource scarcity to prevent and manage musculoskeletal conditions [21]. There is thus a need for evidence-informed, cost-effective and time-efficient management strategies to address CMSP and its consequences within the realities of the transforming SA primary healthcare sector.

Considering the need for the guideline and the array of context factors that may influence pain management in SA, the contextualising approach was proposed. A contextualised CPG was anticipated to offer a bridge between policy and best available evidence, whilst considering local circumstances, service provision factors, clinical expertise and patient choice [22, 23]. The purpose of this article is to describe a novel, practical and resource-efficient method to produce a CPG. The end product was a contextualised, evidence-informed, multidisciplinary CPG for the primary health care of adults with CMSP. We purposefully report on the objectives of our four-phased stepwise contextualisation process, summarised in Table 1. The objectives for each phase were:

The study adds to the body of knowledge of CPG contextualisation as an innovative methodology in the field of CPG development [9]. We investigated a method to contextualise CPGs that were developed in a variety of settings, for use in the SA setting. Contextualisation was indicated considering the difference in contexts of the existing guidelines developed in high-income countries with well-developed healthcare systems, for application in SA, an upper-middle-income country with a transforming healthcare system [19].

A strength of the contextualisation process was the rigorous approach used to gain information about the context of the intended setting. Context plays a role in health behaviour change, knowledge translation, development of context-specific interventions, implementation of interventions and health outcomes [7, 12, 13]. Contextual knowledge considers the real world (authentic) circumstances within which the CPG will be implemented [7, 12, 15] and is therefore an essential component to consider during CPG development. However, there is a shortage of contextual information about specific healthcare environments that would be useful for CPG adoption and adaptation [12, 13]. Sav et al. [41] argues that there is scant evidence for contextual factors in developing countries and culturally different populations. The contextualisation approach accounted for this lack of information by including a systematic situational analysis; however, more research on context factors that influence health care provision is required to diversify the knowledge base. The context information generated in our study was used to incorporate clinical recommendations in a locally applicable clinical pathway and to design context and practice points which framed the recommendations to be relevant to the local context.

Stakeholder perspectives are a key consideration when developing contextually relevant CPGs [22]. Recent studies on alternative guideline development did not focus on including patient perspectives [42‐44]; with some authors citing cost and organisational factors as limiting factors. Schünemann et al. 2017 [12] included patient representatives for their adolopment process. We used a different approach for including patients as stakeholders, by investigating patients’ perspectives on current care and their preferences and needs for optimised pain care. Our findings confirmed the notion that the consideration of patient perspectives in CPG development may enhance patient-centredness and culturally relevant considerations [13, 16, 29]. Congruently, involving clinicians was found to be useful to identify potential training needs and barriers and facilitators regarding uptake of the recommendations. Healthcare practitioners were included in multiple ways in our contextualisation approach, via the contextual analysis, the contextual integration and review phases. During the contextual integration phase, the practitioners used their background knowledge about policies, regulatory requirements, healthcare system factors, workforce considerations and resources, processes of care, feasibility and optimal practice in their decision making [12, 13]. This contextual integration was important, since Gandhi et al. [45], found that the recommendations contained in CPGs they reviewed, were not sensitive to the resource limitations and context factors of low- and middle-income countries (LMIC). Explicitly stating contextual information is not reported to be a key feature of similar alternative CPG endeavours [12, 14, 42‐44]; and the inclusion there-of is a recommendation for future practice. Providing context information and creating an authentic clinical pathway, may facilitate the uptake of CPG recommendations, clinical decision making and quality of health care [33].

Systematically reviewing existing CPGs to produce an evidence synthesis, is central feature of alternative CPG development [9‐12]. In our case, synthesising CPG recommendations from different source CPGs lead to the formation of a hybrid set of multidisciplinary recommendations, which enhanced the holistic scope of the CPG [27]. This feature is imperative, considering the multidimensional impact of CMSP on wellbeing [46]. Assimilation of recommendations from an assortment of high-quality CPGs has been used before by Zhang et al. [3], to develop a core set of recommendations for the management of hip and knee osteoarthritis. A disadvantage of the approach is that the recommendations contained in the contextualised CPG are limited to those contained in the source CPGs. While the expert panel could nominate prioritised additional recommendations, developing new recommendations was beyond the scope of our contextualisation approach. The merging of the recommendations was uncomplicated in our study, however, the assimilation of the body of evidence presented a challenge due to the inconsistent use of frameworks to aggregate the body of evidence and the strength of the recommendation [27]. We therefore formulated context and practice points to indicate elements that may influence the strength of the recommendation. The strength of the recommendation is influenced by the certainty of evidence, and by contextual factors such as acceptability, feasibility, importance of outcomes and resource implications [12]. We suggest a formal process to grade the strength of the recommendation for future contextualisation endeavours as used by similar studies, for example: the GRADE evidence to decision (EtD) framework [12]; the FORM framework (Australian method for formulating and grading recommendations) [30]; or a visual analogue scale rating method [3]. The use of a frameworks and a writing guide is fundamental to ensuring consistency in the CPG development.

CPG contextualisation was found to be a practical, logical, and time- and resource-efficient approach towards developing a contextualised evidence-informed, multidisciplinary guideline for the primary health care of adults with CMSP in a SA setting. The approach provided the opportunity to blend clinical recommendations and multiple stakeholder perspectives within the SA context. The advantages of the contextualisation method are the explicit statements about contextual factors and the identification of indicators for the successful implementation of the guideline. An area for development for the process comprises the formalisation of the use of the strength of the recommendation.