Evaluation of a multimodal pain therapy approach with relapse prophylaxis for back pain (MMS-RFP study): a study protocol for a cluster randomised controlled trial.

INTRODUCTION: The need for an interdisciplinary multimodal approach to the treatment of back pain has already been demonstrated by various studies. However, when considering the periods of incapacity to work in the longitudinal course after the multimodal pain therapy (MPT), limits in terms of its sustainable effect become clear. Patients who receive MPT subsequently return to standard outpatient care, which is associated with a risk of relapse. A 12-month relapse prophylaxis (RP) programme, intended to follow a 4-week MPT, was developed to help patients make the transition to health-conscious and physically active behaviour in everyday life and to identify and prevent impending relapses at an early stage. The evaluation, based on a cluster randomised controlled trial, seeks to provide information on the benefits of early and intensive RP as part of MPT, examine whether it is cost effective, reduces the days of incapacity to work and increases functional capacity, as well as to examine other parameters. METHODS AND ANALYSIS: The study population comprises members of a regional statutory health insurance fund in Germany, who are ≤62 years old, gainfully employed and have been incapacitated for work for at least 21 days due to a diagnosis of back pain. Over a recruitment period of 24 months, a maximum of 368 individuals can potentially be included in the MPT. The intervention group (IG) and control group (CG) will both receive MPT, after randomisation IG will receive RP and CG will receive no further therapy or support as part of the trial. The evaluation is carried out on the following levels: structural, process and results quality. Cost effectiveness is also assessed by means of a health economic evaluation. In addition to the collection of qualitative and quantitative primary data, claims data from the regional health insurance fund are also included in the analysis. ETHICS AND DISSEMINATION: This study has received approval by the ethics committee of the Hannover Medical School (reference number: 8548_BO_S_2019). The study results will be disseminated in national and international journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00017654.

Patient-rated importance of key information on screening colonoscopy in Germany: a survey of statutory health insurance members.

BACKGROUND: Primary colonoscopic screening is considered to be of great benefit but also has the potential to cause severe harm. Thus, eligible subjects should be supported in making an informed choice whether to participate. OBJECTIVES: To identify information on screening colonoscopy that colonoscopy-naïve subjects rate as particularly important for decision making. DESIGN: Survey of German statutory health insurance members using a written questionnaire in November 2015. STUDY POPULATION: Colonoscopy-naïve individuals aged 50 to 65 years. MAIN OUTCOME MEASURES: Importance of key information about screening colonoscopy, including potential risks and benefits, baseline risk of colorectal cancer/polyps and practical aspects of the procedure, as well as associations between participants' characteristics and their judgement of information as to being 'very important'. RESULTS: Of 1871 respondents (overall response rate: 31%), a subgroup of 370 colonoscopy-naïve subjects was eligible for inclusion (average age: 55 years, 47% male). Information on the risks was rated as very important by most respondents, unimportant by 6%. Information on the benefits was considered unimportant by 26%. Regression analysis showed that less educated persons regarded most items to be more often relevant than highly educated subjects. A greater proportion of women than men rated details regarding pain and practical aspects as very important. Subjects with a low educational level living alone were identified as the group with the least interest in information on risks. CONCLUSION: Cultivating awareness around the central meaning of the (quantitative) benefits of screening in informed decision making should be focused on more in future information materials. The high requirement of less educated people to become more informed provides a strong motivation for further efforts to develop evidence-based information that adequately informs this group. Tailoring information according to gender-specific needs may be warranted in light of the observed differences in information preferences between women and men.