The international society for traumatic stress studies new guidelines for the prevention and treatment of PTSD: methodology and development process
Over the last two decades, treatment guidelines have become major aids to the delivery of evidence based care and to improve clinical outcomes. The International Society for Traumatic Stress Studies (ISTSS) produced the first guidelines for the prevention and treatment of posttraumatic stress disorder (PTSD) in 2000 and published its latest recommendations, along with position papers on Complex PTSD, in November 2018. A rigorous methodology was developed and followed; scoping questions were posed, systematic reviews were undertaken and 361 randomized controlled trials were included according to the a priori agreed inclusion criteria. Two hundred and eight meta analyses were conducted and used to generate 125 recommendations (24 for children and adolescents, and 101 for adults) for specific prevention and treatment interventions, using an agreed definition of clinical importance and recommendation setting algorithm. There were 8 Strong, 8 Standard, 5 Low Effect, 26 Emerging Evidence, and 78 Insufficient Evidence to Recommend recommendations. Inclusion of separate scoping questions on treatments for complex presentations of PTSD was considered but decided against due to definitional issues and the virtual absence of studies specifically designed to clearly answer possible scoping questions in this area. Narrative reviews were undertaken and position papers prepared (one for children and adolescents, and one for adults) to consider the current issues around Complex PTSD and make recommendations to facilitate further research. This paper describes the methodology and results of the ISTSS Guideline process and considers the interpretation and implementation of the recommendations. ISTSS Guidelines for PTSD 2 The ISTSS Guidelines for the Prevention and Treatment of PTSD Keeping on top of the proliferation of evidence regarding the prevention and management of health conditions has become a major challenge. As a result, healthcare professionals, policy makers and service planners along with those seeking or using services, increasingly rely on syntheses of available evidence to inform what should be provided and sought. Guidelines, developed through syntheses of evidence, are now widely advocated and followed. The International Society of Traumatic Stress Studie s (ISTSS) produced the first guidelines for the prevention and treatment of posttraumatic stress disorder (PTSD) in 2000 (Foa et al. 2000 and updat ed these in 2009 (Foa et al. 2009 The goal of this paper is to describe the development and facilitate the interpretation of the third version of the ISTSS Guidelines for the Prevention and Treatment of PTSD (ISTSS, 2018) Determining how to interpret and implement guidelines in real life settings can be difficult (Shekelle, 2018) and is made more complicated by different guidelines for the sam e condition drawing different conclusions. The prevention and treatment of PTSD is a good example of this, with a number of guidelines from reputable sources (e.g. the UK's National Institute for Health and Care Excellence (NICE, 2005) American Psychological Association (APA, 2017) US Veterans Affairs /Department o f Defense (VA/DoD, 2017) Phoenix Australia (2013) and the ISTSS providing overlapping but non identical recommendations in recent years (Forbes et al. 2010; Hamblen et al. 2018) The unavoidable conclusion is that guideline development is an imprecise science, with multiple degrees of freedom in the process, and the subsequent clinical recommendations may vary depending on the methodology used. This situation has resulted in calls for greater standardization of guideline development and a more harmonious approach among guideline developers in the future (IoM, 2011) ISTSS Guidelines for PTSD 3 It is widely advocated that guideline developers rely on systematic reviews o f research evidence with quality and strength of evidence being taken into account before determining how strongly to recommend a particular intervention (IoM, 2011; GRADE, 2018) This has, inevitably, led to the adoption of a hierarchy of evidence. Most such hierarchies consider randomized controlled trials (RCTs) the gold standard to determine what does and does not work (Eccles Mason, 2001) Critics argue, however, that potentially important evidence generated outside RCTs is ignored and can devalue the recommendations made (Henriques, 2018) This concern echoes the sentiments of the founders of evidencebased practice who said, "Good healthcare professionals use both individual clinical expertise and the best available external evidence, and neither alone is enough." (Sackett et al. 1996 Taking a more inclusive approach to evidence sources offers the opportunity to include treatment approaches that have not been subjected to randomized controlled trials. However, this approach also comes with costs. The interpretation and comparison of results from different research designs is complicated and risks interventions that lack robust evidence being recommended more strongly than they should be. The inferences that can be drawn from study designs other than a well controlled RCT may be very biased and, therefore, not yield sufficient information to make evidence based recommendations. The first two versions of the ISTSS Guidelines took a more inclusive approach to the evidence and recommendations were based on methodologically variable reviews of the literature by individuals with an interest in a particular topic area. Although this reflected common practice at the time, this approach is inconsistent with current standards and can be criticized for not adopting a priori decision rules that are objectively applied. More recent PTSD guidelines have adopted a more standardized methodology (e.g. NICE, 2018; APA, 2017; Phoenix Australia, 2013; VA/DoD, 2017; W HO, 2013) whereby specific questions were ISTSS Guidelines for PTSD 4 developed and independent systematic reviews undertaken to answer them, with expert s following more formal process e to determine final recommendations. With this backdrop, in 2015, the ISTSS Board of Directors decided to update its prevention and treatment guidelines for PTSD. It sought to generate guid elines through a robust methodological process that would be helpful to the traumatic stress field. The resulting guidelines will provide practitioners, service planners, policy makers, people with li ved experience of PTSD and other relevant stakeholders with accurate information on what works and what does not work to prevent or treat PTSD. This effort resulted in the publication of the ISTSS Guidelines for the Prevention and Treatment of PTSD recommendations and position papers in November 2018 (ISTSS, 2018) These publications will be complemented by the final part of the updated ISTSS Guid elines, the third edition of the "Effective Treatments for PTSD " book, due to be published at the end of 2019, with a primary goal of providing a resource for clinicians to apply the recommendations to clinical practice. Method The ISTSS Board appointed an ISTSS Guidelines Committee (the authors of this paper) to develop its guidelines. The committee adopted a methodology that involved th ree distinct steps: (1) development of scoping questions to guide the review, (2) systematic reviews of the literature to identify RCTs that could answer the a priori scoping questions and (3) meta analyses of usable data from the included studies to allow the generation of recommendations for prevention and treatment interventions. Scoping Questions The Committee agreed on draft scoping questions in a Population, Intervention, Comparator, and Outcomes (PICO Schardt et al. 2007 format for the prevention and treatment of PTSD in children, adolescents and adults (e.g. "For adults with PTSD, do ISTSS Guidelines for PTSD 5 psychological treatments, when compared to treatment as usual, waiting list or no treatment, result in a clinically important reduction of symptoms, improved functioning/quality of life, presence of disorder, or adverse effects?" Separate draft scoping questions were developed to address the prevention or treatment of PTSD (clinically relevant posttraumatic stress symptoms in the case of children and adolescents) The committee consulted on the draft scoping questions with the ISTSS membership and reference groups of practitioners and nonpractitioner consumers for feedback before presentation to and approval by the ISTSS Board. Inclusion of separate scoping questions on treatments for complex presentations of PTSD for children/adolescents and adults was considered but decided against due to issues defining Complex PTSD (CPTSD) and the virtual absence of studies specifically designed to clearly answer possible scoping questions in this area. The Committee decided, therefore, to undertake a narrative review and prepare position papers (one for children and adolescents, and one for adults) to consider the current issues around CPTSD and make recommendations to facilitate further research. Systematic Reviews and Meta Analyses High quality systematic reviews developed by the Cochrane Collaboration, NICE and the WHO were identified that addressed all the scoping questions except those pertaining to non psychological and non pharmacological interventions. RCTs included in these reviews were used as the basis of the evidence to be considered for the ISTSS guidelines. Existing reviews (Rose et al. 2005; Roberts et al. 2009; Roberts et al. 2010; Bisson et al. 2013; Hoskins et al. 2015; Sijbrandij et al. 2015; Lewis et al. 2015; NICE, 2018) were supplemented with additional systematic searches for more recent RCTs, and by asking experts in the field as well as the ISTSS membership to identify any studies that might have been omitted. New systematic reviews were undertaken for the non psychological and nonpharmacological scoping questions. The Cochrane Collaboration Mental Health Disorders ISTSS Guidelines for PTSD