Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions

OSCAR (Osteopathic Single CAse Research) – assessing the effect of standard and biopsychosocial osteopathic management for patients with non-specific low back pain: protocol for a Single Case Experimental Design (SCED)

Background Osteopathy has been shown to be effective in the management of chronic low back pain (LBP). Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific LBP. Objectives This study has four aims: 1/to assess how patients with LBP improve after osteopathic treatment, both before and after an osteopath has completed a Biopsychosocial Pain Management course; 2/to assess if it is feasible and acceptable for osteopaths to receive weekly SCED data and use it to guide patient management; 3/to assess if it is acceptable for patients to submit daily data and discuss weekly summary with their osteopaths; and 4/to test feasibility for researchers in collecting, managing and storing large quantities of individual patient data. Methods A multiple baseline single case experimental design trial with up to 10 UK osteopaths with more than 15 years in practice and 60 patients will assess how change occurs as a result of osteopathic treatment for patients with non-specific LBP of more than 12 weeks’ duration. Statistical analysis will assess the degree and rate of change between baseline, intervention and follow-up periods, and whether differences in effect are observed after the osteopaths have completed the biopsychosocial patient management training course. Primary outcomes will be the Numeric Pain Rating and Patient Specific Function Scales, measured daily at baseline and for 6 weeks during the intervention stage, and weekly or fortnightly during a 12-week follow-up period. Ethics This research was approved by the XXX Research Ethics Committee