Background. Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. Objectives. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions. Methods. Three Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinical trials were conducted. The panel was presented with a systematic review and meta-analysis of control and blinding methods. A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives. Results. Forty-four experts completed the process. When treatment efficacy or mechanisms are to be studied, the advocated principle is to design control interventions as similar as possible to the tested intervention, apart from the components that the study examines. Structured reasoning in the planning phase, early engagement with stakeholders, feasibility work, and piloting will enhance the quality and acceptability of control interventions. With participant blinding being a primary objective, blinding effectiveness should be routinely assessed and reported. Transparent and detailed reporting will improve interpretability and repeatability of clinical trials. Conclusion. This guideline provides the much-needed standards to enhance the quality of efficacy clinical trials in physical, psychological, and self-management intervention research, ultimately improving patient care. Study registration: . https://osf.io/jmyhq/. Conflict of interest: The authors declare no competing interests. Sources of Funding: Alain and Sheila Diamond Charitable Trust PhD Studentship

Purposes. To develop disease-specific quality indicators for patients with low-back-pain presenting to Danish chiropractic clinics. Methods and results. A cross-disciplinary group of healthcare providers (the indicatorgroup) prioritized nine evidensbased indicators and standards in a systematic consensus process. A pilot test including 206 low-back-pain patients was carried out in eight chiropractic clinics. An audit meeting with the test-clinics was conducted after the test-period, and the indicatorgroup designed the final set of indicators. The indicator domains were: Anamnesis, test for discogenic back pain, neurology, radiology, classification, exercise therapy, outcome assessment (process and result) and re-evaluation. Two indicators: outcome assessment as a process-indicator (standard ≥ 95 %, standard reached (95% CI): 95.8 % (91.6 – 98.3)) and outcome assessment as a result-indicator (standard ≥ 50 %, standard reached: 67.7 % (59.9 – 74.8)) met the standards set by the indicatorgroup. After evaluating the test-results the indicatorgroup decided to maintain all nine indicators, however, lowering the standards on anamnesis, discogenic back pain and classification. Conclusion. It was possible to identify the patient population and collect data with regard to the nine indicators. At the time being primary care chiropractic clinics in Denmark do not meet the quality standards set by professionals. This may however be partly due to practical problems in the data collecting process. Both the indicatorgroup and the test-clinics, recommend future nationally widespread implementation of the developed indicators. This could be the first step in joining the Danish healthcare accreditation programme