Background
Clinical Practice Guidelines (CPGs) were defined by the United States of America Institute of Medicine in 2011 as
‘statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’ (p.4) [
1]. Recently they were described as ‘
a convenient way of packaging evidence and presenting recommendations to healthcare decision makers‘(p.6) [
2].
Methodologically-sound CPGs should be developed using standard internationally-agreed principles, and be based on the best current evidence [
3]. Such CPGs can provide policy-makers, clinicians, funders and service managers with time-efficient and reliable sources of current evidence on which to base service-delivery decisions [
4]. CPGs may also include ‘how to do it’ documents such as written recommendations with underpinning levels of evidence, algorithms and patient decision/ management tools, protocols or directives [
5]. These are designed for busy end-users (clinicians, managers) who require readily accessible information about putting best evidence into practice [
3,
4].
CPGs usually deal with one or more questions about screening, diagnosis, treatment, monitoring and/or cost-effectiveness of care decisions [
6]. CPGs which include allied health (AH) recommendations for specific conditions are increasingly available internationally. AH is an umbrella term, encompassing health disciplines which are often defined by exclusion (not medicine, nursing, veterinary science or dentistry), and where AH professions are variably named in lists, depending on where they work [
7‐
9]. Generally AH care focuses on morbidity, not mortality [
9]. It is currently accepted that ‘AH’ encompasses therapies, diagnostic and technical, scientific and complementary disciplines/professions [
7‐
9]. AH therapies, the focus of the research reported in this paper, provide screening, diagnosis, treatment, education and /or monitoring services across the lifespan, mostly to alleviate sequelae of disease [
7‐
9]. AH therapies provide care for individuals in primary, secondary and tertiary settings, to improve their function and quality of life from injury or illness [
8,
9].
The Guidelines Intercollegiate Network (G-I-N) recently produced a position statement outlining four themes (comprising 14 items) relevant to enhancing a person-centred approach in AH CPGs
(‘i. use a joint definition of health-related quality of life as an essential component of intervention goals, (ii) incorporate the International Classification of Functioning, Disability and Health (ICF) as a framework for considering all domains related to health, (iii) adopt a shared decision-making method, and (iv) incorporate patient-reported health outcome measures’ (p 1543) [
10]. Often, AH recommendations are embedded in condition-specific CPGs which provide guidance to other healthcare providers (e.g. Australian Guidelines on Management of Type 2 Diabetes 2011 [
11]). Thus AH providers interested in using CPGs may have to search first for a condition-specific CPG and then find discipline-relevant recommendation(s) embedded within it. Whether AH recommendations are provided in a disease-specific CPG depends on CPG purpose and intended end-users. To improve ease of access for end-users, profession-specific summary guidance can also be produced from a large multidisciplinary CPGs (e.g. separate guidance documents for physiotherapy, occupational therapy, speech and language/hearing and social work produced from the Australian National Stroke Foundation CPG for acute stroke management [
12]. Profession-specific CPGs are also available, usually produced by professional associations (eg American Physical Therapy Association low back pain CPG) [
13]. Access to, and uptake of, AH CPGs is aided by freely-available ‘one-stop-shops’ such as CPG repositories on respected CPG developers’ websites (eg Scottish Intercollegiate Guidelines Network website (
http://www.sign.ac.uk/)) [
14] or national independent CPG clearing houses (such as hosted by US Agency for Healthcare Research and Quality
http://www.guideline.gov/) [
15].
Effectively implementing CPGs into every-day AH practice is an evolving area of research [
10,
16,
17]. Whilst good quality CPGs are generally available at no cost for many health conditions, barriers to uptake of CPGs by AH providers have been consistently reported. These include lack of time and knowledge to find CPGs, constrained knowledge about CPG construction and how to assess their quality, lack of organisational will and/or managerial support to embed CPGs routinely into local practice, limited access to CPGs because of infrastructure constraints (eg internet access or library facilities), and local referral and/or prescription systems which may restrict AH clinical autonomy [
15‐
19].
The World Health Organisation (WHO) reported on characteristics for good quality service delivery (WHO 2010), which need to be considered in AH CPGs [
20]. This work importantly separates best practice interventions (mostly derived from experimental studies) from operationalisation of services (how best to put interventions into practice). Quality service delivery characteristics reflect inputs (Workforce; Service comprehensiveness; Resources; Continuity; Coordination; Accountability) and outputs (quality care processes, and quality health outcomes). Outputs can be measured in different ways including Person-centredness; Efficiency; Equality (individual rights to care); Equity (coverage); Access; Timeliness; and Effectiveness. Provision of quality service delivery guidance in CPGs used by AH therapists, managers and policy-makers is as important as information on interventions, because by its very nature, quality AH care is not just about what is done, but also about who does it, how often it is done, how much care is delivered, who takes responsibility for it and how it integrates with patient-locus of control [
7‐
9,
15‐
19,
21].
Internationally there is a lack of information on if, how,and why CPGs are used in AH, and whether the benefits of using them outweigh the costs [
8‐
10,
22,
23]. This paper reports on perspectives of CPGs by end-users in primary health care (PHC) settings in South Africa (SA). Resources for AH generally, and for any AH CPG activity, have been constrained for three decades in SA, despite an escalating and currently unmet need for best-evidenced, standardised guidance to address the increasing prevalence of communicable and non-communicable diseases [
24‐
26]. Since it became a government priority in the 1994 National Health Plan, SA has consistently acknowledged the importance of PHC [
27,
28]. PHC providers (GPs, nurses or allied health practitioners) attend to South Africans’ healthcare needs over their lifespan, and PHC is usually the point of patient entry into the SA healthcare system [
24,
25]. In SA, clinical guidance is developed by many groups including the National and Provincial Departments of Health, and professional societies [
28]. There is however, no central, nationally recognized and accepted CPG development unit in place, and no support for AH CPG activities to improve PHC quality and health outcomes.
Moreover, whilst there is a regulatory authority (Allied Health Professions Council of South Africa) [
29], there is little publically-available information on what any AH discipline does, to whom or how, or with what outcome. SA is a land of contrasts, evident in variable AH care provision, access, affordability and consumption. Some patients can access the very latest technology in large tertiary hospitals, whilst others can only access basic levels of PHC in rural communities [
28]. Geography, culture, economy, education and social justice play a large part in who consumes SA AH services, and with what outcome. Thus people’s capacity to pay, their belief in the benefits of different AH providers, and providers’ skill sets and availability, will often dictate patient choice in consuming treatment [
22,
25,
26,
28]. In the past 20 years, there has been little SA focus on the importance or benefit of AH PHC care, as government priorities have been on reducing mortality from communicable diseases such as HIV/AIDS, TB and malaria [
28‐
31]. Now that this war is gradually being won, and more people are now living with these diseases as chronic conditions, recognition is growing of AH as having the requisite skills to optimise function and quality of lives saved [
29‐
32]. Anecdotally, the demand for PHC AH services is escalating, but this is not currently matched by sufficient workforce or resourcing, nor on a sound evidence base for practice [
30‐
32].
This paper reports findings from a sub-study in Goal 1, in the South African Guidelines Evaluation (SAGE) project. Project SAGE was funded by a South African Medical Research Council Flagship research grant 2013–2017 [
33]. It had five goals. Goal 1 sought information from key medical and policy participants on PHC CPG needs, development, relevance, uptake and implementation in SA. It became apparent during Goal 1 data collection that the voices of other players in SA PHC settings also needed to be heard. Thus the Goal 1 AH sub-study was undertaken to capture perspectives on AH PHC CPG from knowledgeable SA PHC AH policy-makers, academics, managers and clinicians. Key Project SAGE findings are reported in South African Medical Journal editorials [
24‐
27]. Three journal articles report on South African CPG quality [
5,
28,
29], and one reported on a novel conceptual framework was reported of stacking tiers of activity to efficiently underpin production of implementable CPGs for local uptake [
34].
Given the immense, increasing challenges in front of SA AH policy-makers, managers and clinicians to deal efficiently with the increasing tsunami of people with chronic diseases who require PHC services to improve function and quality of life, the Project SAGE AH substudy was timely. It provided a rare opportunity to explore AH end-user perspectives on CPGs, which could potentially support delivery of cost effective and efficient services to increasing numbers of patients not previously considered in government estimates4,10,28–31. This paper established the current ‘state of play’ of CPG activities in PHC AH in SA by synthesising perspectives of knowledgeable AH players.
Methods
Ethics
Ethical approval was provided by the three participating organisations in Project SAGE: Medical Research Council (EC002–2/2014), Stellenbosch University (N14/02/008) and University of South Australia (0000034923).
Qualitative research approach
The research was conducted and reported in accordance with the COREQ criteria, the current gold standard for qualitative research [
35]. This study took a descriptive, inductive approach to develop a framework that would assist us to efficiently analyse data amassed from the stories of individuals aligned with pre-determined clusters of activity relevant to PHC AH CPGs [
36‐
38]. This sampling framework was essential to ensure a rigorous recruitment strategy, and appropriate classification and analysis of the rich interview data provided by participants. Additional file
1 reports the semi-structured interview guide. These questions were the same as those asked of the medical and policy-maker participants in Project SAGE Goal 1 interviews.
Research team
The team consisted of three AH researchers with experience in CPG writing and implementation (KAG, JMD, QAL), a public health epidemiologist with systems analysis expertise (SM) and a social scientist (HP). The researchers were all experienced interviewers, with formal training in interview and focus group data collection methods, and qualitative research analysis and reporting.
Therapy focus and overview
The SAGE AH sub-study focused on the four most common AH therapies in South African PHC: physiotherapy, occupational therapy, podiatry, and speech and language/ hearing. In South Africa, these therapies operate in public and private PHC, in metropolitan, regional and rural settings. These AH clinicians generally have first contact practitioner status in the private sector, where they can provide services without a medical referral. However there is variable first contact status in the public sector, depending on the availability of medical practitioners, the environment and usual local practices. In rural public PHC settings, these AH therapists regularly provide services in South African in the absence of a doctor [
31].
Sample
Our sampling reference frame [
33] enabled us to identify and purposively recruit for maximum variation, individuals with experience and knowledge of PHC AH CPG activities, using a cluster recruitment strategy [
36]. Pre-establishing the sampling frame was critical to complying with COREQ reporting standards 10 and 11 [
35]. This approach was particularly important given how little we knew about the activities in CPGs in South African AH PHC. Sampling clusters comprised:
-
AH / rehabilitation portfolios of National and four provincial governments. Provinces were selected on heterogeneity of economics, size, population distribution, and access to tertiary training
-
managers of rehabilitation services at district and sub-district level
-
public sector discipline-specific clinicians at district, sub-districts and community levels
-
professional discipline-specific associations
-
private sector discipline-specific clinicians
-
special interest groups (multidisciplinary or single discipline)
-
tertiary training institutions teaching single discipline programs
-
medical aids (health insurance companies) and
-
CPG writers/ consultants.
Sample identification
A combination of chain and maximum variation sample generation process [
33,
35,
36]started with key informants being identified within the Project SAGE team. These were researchers or students who were not necessarily interviewed, but who knew of key individuals in the pre-identified clusters. They were approached to participate, and even if they did not agree to interview, they were asked for names of others who might meet the inclusion criteria. This approach assisted us to identify relevant AH clusters in different ways (by discipline, organisation, purpose and dependence (or independence) on other clusters). Purposive sampling continued until all clusters had been populated with consenting interviewees.
Researchers’ relationship with participants
One researcher (QAL) was known to eight participants, and a second researcher (KAG) was known to four participants (four being common to both QAL and KAG). When inviting participants to join the research, the researchers declared their position (and prior knowledge), and the intent of the research. They clarified ways in which participants’ anonymity would be protected. Prior to interview, all interviewees reviewed the information sheet, signed the consent form and clarified issues and concerns.
Data collection processes
Data were collected formally by individual interview, or focus groups. Signed consent forms were collected and audio recordings were made. Data was also collected informally in individual interviews or small group meetings, where signed consent forms were collected, but by agreement, only meeting notes were taken (no audiotapes). This occurred when participants wanted to talk ‘off the record’. When participants provided ‘off the record’ information, this was used as background material, and/or for verification of information provided in formal recordings.
The researcher worked in pairs when conducting interviews. Interviewer dyads changed regularly. Having the same people involved in data collection maintained continuity in questioning and note-taking, and supported efficient subsequent data handling and analysis [
35‐
37]. At each interview one interviewer led, and one took field notes. This person contributed additional questions to the interview, if further clarity was required. A ‘reflective’ interviewing technique was used, which summarised, in the researchers’ words, what had been heard in the interview, to which participants were invited to clarify, amend or further expand [
35‐
37]. As relevant, issues raised in one interview were introduced in subsequent interviews so that a cohesive and evolving picture of AH CPG perspectives was developed during the study. Member checking of interview transcripts was offered to all participants.
Once we suspected that we had reached saturation in any cluster (where nothing new was heard since the last interview), one further interview (formal or informal) was conducted with the next participant. If no new information was forthcoming, interviewing in that cluster stopped at that point. However, if new information was found in that interview, further sampling and interviewing occurred until data saturation was achieved [
35,
36,
39].
Analysis approach
Analysis was undertaken using paper copies of transcripts, where answers to the semi-structured interview questions were inferred as ‘chunks’ of meaning, from sentences or paragraphs. Transcript analysis was undertaken independently by all authors then meetings were held to discuss themes and sub-themes identified. All authors agreed on the final themes and sub-themes and collaborated in drafting this paper, and identifying exemplar quotations to support better understanding of the ‘current state of play’. The key themes and sub-themes described who was involved in CPG activities (and in what roles), why, and for what purpose, CPG activities were undertaken, CPG terminology, and drivers for CPG activity.
Building the framework
A framework was developed to capture key issues, wording of questions which could initiate future discussion on these issues, and ways in which this information could be interpreted. This framework assisted us in reporting our findings, and may also inform future research elsewhere, investigating the same concerns.
Discussion
This study presents comprehensive and new information on the role of CPGs in AH PHC, in a country which has significant challenges in dealing with an increasing burden of chronic disease and disability. Our cluster sampling approach was supported, as we heard of no new clusters during the interviews [
33,
37,
40]. Pre-planning the clusters and asking for new participants throughout the interviews, ensured that we heard from the right people, to develop a clear understanding of the current complex ‘state of play’ of CPGs in AH engagement with South African PHC settings.
The need for evidence-based guidance for quality AH PHC practices was widely acknowledged, but significant barriers to obtaining and implementing such guidance were also identified. These barriers replicated reports from other countries [
17,
18], however there were additional complexities in terms of South African PHC needs [
22,
24‐
28]. There was a widespread belief that implementation of good quality CPGs might improve the quality of local care, and assist in dealing with scant resources, huge community need, lack of standardised training, and Government focus on priorities other than quality of life and functionality. However there was also a disconnect between participants’ perceptions of what CPGs were, how they were produced, and how guidance was presented and implemented in local PHC settings, and the realities of effectively producing and putting locally-relevant CPGs into practice across the country.
AH therapies have a remit ‘
to develop, maintain and restore maximum movement and functional ability throughout the lifespan. This includes providing services in circumstances where movement and function are threatened by ageing, injury, pain, diseases, disorders, conditions or environmental factors. Functional movement is central to what it means to be healthy’ (WCPT 2011) [
41]. This puts AH therapies at the forefront in SA PHC, in dealing proactively with the tsunami of improving the quality of lives saved from previously fatal communicable diseases.
In our framework (Fig.
1), we have provided a methodological approach that could assist researchers in South Africa, and other countries, to investigate local AH perspectives on CPGs. This framework is particularly relevant in situations where AH PHC is variably available, affordable or accessible, and where there are complexities in how AH care is delivered, funded and consumed.
We found a range of clinical guidance in SA for AH PHC, presented in many forms. Whilst it had been produced with the best of intentions, little of it was based on best evidence, none of it was peer-reviewed or available through a central repository, and most of it related to local service delivery issues that may not be generalisable. Many of the existing (so called) CPGs were not based on best practice CPG development principles [
2‐
4], and the underpinning evidence-bases were questionable. Thus these documents could not realistically be called CPGs because they did not meet international standards [
2‐
4]. The gaps between what is expected international best practice in CPG writing, and what was produced, was the result of lack of understanding of the elements of CPGs, coupled with lack of training, time, expertise, manpower, access to evidence sources, being clear on the purpose of the guidance, and financial resources.
Significant support exists across SA for better quality AH CPG writing and implementation, if one capitalises on the vibrant informal AH networks, and the formal organisations such as medical aids (insurers), professional associations, academic institutions and national and provincial government disability portfolios. However training is required to build capacity, ensure standard understanding, and efficiency of effort. Thus the way forward is to offer specific training, develop a central CPG repository, and seek formal supports from government, and national and local organizations in order to build knowledge, skills and capacity.