Methods for specifying the target difference in a randomised controlled trial : the Difference ELicitation in TriAls (DELTA) systematic review

Peer reviewedPublisher PD

Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.</p> <p>Methods/Design</p> <p>This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave.</p> <p>Discussion</p> <p>This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice.</p> <p>Trial registration</p> <p>ISRCTN 68205910</p

EULAR recommendations for the health professional’s approach to pain management in inflammatory arthritis and osteoarthritis

Pain is the predominant symptom for people with inflammatory arthritis (IA) and osteoarthritis (OA) mandating the development of evidence-based recommendations for the health professional’s approach to pain management. A multidisciplinary task force including professionals and patient representatives conducted a systematic literature review of systematic reviews to evaluate evidence regarding effects on pain of multiple treatment modalities. Overarching principles and recommendations regarding assessment and pain treatment were specified on the basis of reviewed evidence and expert opinion. From 2914 review studies initially identified, 186 met inclusion criteria. The task force emphasized the importance for the health professional to adopt a patient-centered framework within a biopsychosocial perspective, to have sufficient knowledge of IA and OA pathogenesis, and to be able to differentiate localized and generalized pain. Treatment is guided by scientific evidence and the assessment of patient needs, preferences and priorities; pain characteristics; previous and ongoing pain treatments; inflammation and joint damage; and psychological and other pain-related factors. Pain treatment options typically include education complemented by physical activity and exercise, orthotics, psychological and social interventions, sleep hygiene education, weight management, pharmacological and joint-specific treatment options, or interdisciplinary pain management. Effects on pain were most uniformly positive for physical activity and exercise interventions, and for psychological interventions. Effects on pain for educational interventions, orthotics, weight management, and multidisciplinary treatment were shown for particular disease groups. Underpinned by available systematic reviews and meta-analyses, these recommendations enable health professionals to provide knowledgeable pain management support for people with IA and OA

Influences of Sex, Education, and Country of Birth on Clinical Presentations and Overall Outcomes of Interdisciplinary Pain Rehabilitation in Chronic Pain Patients: A Cohort Study from the Swedish Quality Registry for Pain Rehabilitation (SQRP)

This study investigates the effects of sex, education, and country of birth on clinical presentations and outcomes of interdisciplinary multimodal pain rehabilitation programs (IMMRPs). A multivariate improvement score (MIS) and two retrospective estimations of changes in pain and ability to handle life situations were used as the three overall outcomes of IMMRPs. The study population consisted of chronic pain patients within specialist care in the Swedish Quality Registry for Pain Rehabilitation (SQRP) between 2008 and 2016 at baseline (n = 39,916), and for the subset participating in IMMRPs (n = 14,666). A cluster analysis based on sex, education, and country of origin revealed significant differences in the following aspects: best baseline clinical situation was for European women with university educations and the worst baseline clinical situation was for all patients born outside Europe of both sexes and different educations (i.e., moderate-large effect sizes). In addition, European women with university educations also had the most favorable overall outcomes in response to IMMRPs (small effect sizes). These results raise important questions concerning fairness and equality and need to be considered when optimizing assessments and content and delivery of IMMRPs for patients with chronic pain.Funding Agencies|Swedish Research CouncilSwedish Research Council [2018-02470]; County Council of Ostergotland (Research-ALF) [LIO-700931]</p

U-PAIN cohort study among patients with chronic pain in specialised pain care: a feasibility study

Objectives To examine acceptability of study participation and feasibility of (1) recruitment, (2) data collection and (3) outcome measures for the prospective U-PAIN cohort. Design Internal feasibility study of a prospective cohort. Participants and setting 64 patients, &amp;gt;18 years, with chronic pain at a multidisciplinary pain centre at a university hospital in Sweden. Outcome measures Acceptability of study participation was measured with a study-specific 10-item Likert scale. A score &amp;lt;3 was considered feasible, for the two items that assessed respondent burden a higher score indicated lesser participant burden and a score &amp;gt;3 was feasible. Recruitment was assessed by participation rates at baseline and retention at the 1-year follow-up, with threshold values for feasibility at 75% and 80%, respectively. Data collection and outcome measures were examined by completions rates of study procedures (90% was considered feasible), sample scores, internal consistency (alpha&amp;gt;0.70 was considered feasible), and agreement between self-reported data and data retrieved from medical records on opioid use (ICC or kappa&amp;gt;0.60 was considered feasible). Results Acceptability for study procedures was feasible, but participation rates were low: 25%. The retention rate at 1-year follow-up was 81% for those included in the feasibility study, that is, filling out computerised patient-reported outcome measures, and 65% for those using paper and pencil format. The completion rates for the different data collection methods ranged from 83% to 95%. Agreement between self-reported opioid use and prescribed dose and between opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and clinical International Classification of Diseases-10 (ICD-10) diagnoses for opioid dependence were almost perfect (kappa=0.91and kappa=0.90, respectively). Conclusions This feasibility study has helped to explore and improve methods for recruitment, data collection and use of outcome measures for the U-PAIN cohort. Low participation rate and high refusal rate at baseline is a challenge that needs to be further addressed.Funding Agencies|Swedish Research Council [2016--01582]</p