An interpretive review of consensus statements on clinical guideline development and their application in the field of traditional and complementary medicine

Hunter et al. BMC Complementary and Alternative Medicine (2017) 17:116 DOI 10.1186/s12906-017-1613-7 RESEARCH ARTICLE Open Access An interpretive review of consensus statements on clinical guideline development and their application in the field of traditional and complementary medicine Jennifer Hunter1,2* , Matthew Leach3, Lesley Braun1,4,5 and Alan Bensoussan1 Abstract Background: Despite ongoing consumer demand and an emerging scientific evidence-base for traditional and complementary medicine (T&CM), there remains a paucity of reliable information in standard clinical guidelines about their use. Often T&CM interventions are not mentioned, or the recommendations arising from these guidelines are unhelpful to end-users (i.e. patients, practitioners and policy makers). Insufficient evidence of efficacy may be a contributing factor; however, often informative recommendations could still be made by drawing on relevant information from other avenues. In light of this, the aim of this research was to review national and internationally endorsed consensus statements for clinical guideline developers, and to interpret how to apply these methods when making recommendations regarding the use of T&CM. Method: The critical interpretive review method was used to identify and appraise relevant consensus statements published between 1995 and 2015. The statements were identified using a purposive sampling technique until data saturation was reached. The most recent edition of a statement was included in the analysis. The content, scope and themes of the statements were compared and interpreted within the context of the T&CM setting; including history, regulation, use, emerging scientific evidence-base and existing guidelines. Results: Eight consensus statements were included in the interpretive review. Searching stopped at this stage as no new major themes were identified. The five themes relevant to the challenges of developing T&CM guidelines were: (1) framing the question; (2) the limitations of using an evidence hierarchy; (3) strategies for dealing with insufficient, high quality evidence; (4) the importance of qualifying a recommendation; and (5) the need for structured consensus development. Conclusion: Evidence regarding safety, efficacy and cost effectiveness are not the only information required to make recommendations for clinical guidelines. Modifying factors such as burden of disease, magnitude of effect, current use, demand, equity and ease of integration should also be considered. Uptake of the recommendations arising from this review are expected to result in the development of higher quality clinical guidelines that offer greater assistance to those seeking answers about the appropriate use of T&CM. Keywords: Evidence based medicine, Guideline, Practice guideline, Complementary medicine, Integrative medicine, Literature review * Correspondence: 1 NICM, University of Western Sydney, Locked Bag 1797, Penrith, NSW 2751, Australia 2 Menzies Centre for Health Policy, School of Medicine, University of Sydney, Sydney, Australia Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Hunter et al. BMC Complementary and Alternative Medicine (2017) 17:116 Background Traditional and complementary medicine (T&CM) refers to a conglomerate of health-related interventions and therapies not usually considered mainstream by the Western medical system. T&CM includes (but is not limited to) naturopathy, traditional Chinese medicine, Ayurvedic medicine, homeopathy, chiropractic, osteopathy, massage therapy, yoga and meditation. In such a multifarious field with divergent training requirements, different models of regulation, and myriad treatment options informed by varying (and sometimes inconsistent) evidence, it is not surprising there is considerable diversity in clinical practice [1]. The impact of these inconsistent practices on patient outcomes, patient satisfaction and professional credibility can be significant [2]. Clinical guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” [3] that aim to reduce unnecessary variations in service delivery by informing a rational approach to the management of patients, as well as guiding healthcare policies. Evidence-based clinical guidelines were initially almost solely based on evidence of efficacy and safety [4–6]. The limitation of this approach was that it ignored other important considerations when developing guidelines to meet the healthcare needs of a population [7]. Increasingly, the importance of contextual information and qualifying statements about the burden of disease, economic impact, current use, patient values and preferences and equity, and the need for transparency throughout the development process have been adopted as guideline development standards [8–10]. Despite these standards, it is not uncommon for clinical guidelines and health policies regarding T&CM to only consider the evidence for safety, efficacy and cost-effectiveness, if they are considered at all [11]. The quality of clinical guidelines continues to be a matter of concern, hence the development of various guideline appraisal tools such as the AGREE II [12, 13]. In the field of T&CM, standard medical guidelines are fraught with inconsistencies and unhelpful recommendations. For example, reviews of guidelines endorsed by the UK National Institute for Health Care and Excellence (NICE) or the Scottish Intercollegiate Guidelines Network (SIGN) have found that many lacked transparency and consistency about the inclusion or exclusion of T&CM [14–16]. The conclusions drawn from the available evidence often overestimated or underestimated potential benefits. In many instances, even when one or more T&CM interventions were reviewed by the guideline developers, either no recommendations or nonspecific recommendations, such as ‘practitioners should discuss T&CM use with their patients’ or ‘more research is needed’ were made. General statements provide little guidance for clinical decision Page 2 of 11 making and could be viewed as ‘holding statements’ rather than serving any real purpose. Given the aforementioned findings, clinical guidelines of higher quality are urgently required to guide the safe and rational use of T&CM in practice (...truncated)