The Role of Harms and Burdens in Clinical Practice Guidelines: Lessons Learned From the American Psychological Association's Guideline Development

Growing evidence supports the efficacy of various psychosocial interventions yet provides very little information about the potential harms and burdens of treatment. Lacking such information makes it difficult to make truly informed decisions about treatment options. This has proved challenging for clinical practice guideline developers, who seek to synthesize the best available research, including weighing perceived benefits, harms, and burdens of treatments, in order to formulate recommendations for clinicians, patients, and policy makers. This paper overviews the problem along with current and future implications and challenges for guideline development, including an example from the American Psychological Association's guideline on PTSD treatment. Adequate definition and reporting in published treatment trials is critical for the field to formulate careful treatment recommendations and guidelines. Public Health Significance StatementClinical practice guidelines have an increasingly important role in health care. In order to be fully utilized, an understanding of not only the potential benefits of treatments but also the potential harms and burdens of treatments is necessary for informed decision making. The current lack of consistent definitions of treatment harms and burdens and the paucity of data on the topic hamper the ability of guideline developers to create well-documented and supported recommendations, and therefore limit the information providers and patients have to inform their decision making. This is particularly problematic for treatment of mental and behavioral problems, as trials of medications are more likely than trials of psychosocial interventions to report such information. This could result in more attention provided to psychopharmacology at the expense of psychosocial care, simply because more complete information about both benefits and harms is available to inform decision making. The end result is that patients may be presented with fewer treatment options, potentially limiting their ability to find the right treatment for the individual situation. This paper provides an overview of the problem and the specific current and future implications and challenges for guideline development.