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ObjectivesTo determine the feasibility of a patient-education booklet to support patients with low back pain (LBP) to reduce paracetamol intake.DesignSingle group, repeated measures feasibility study.SettingCommunity.ParticipantsAdults experiencing LBP of any kind and self-reporting consumption of paracetamol for LBP weekly for at least 1 month were invited to participate.InterventionParticipants received a patient-education booklet 1 week after the baseline measures were collected. The intervention was designed to change beliefs, increase knowledge and self-efficacy to deprescribe paracetamol for their LBP and create discussion with a health professional through the mechanisms of motivation, capacity and opportunity.Primary outcome measuresFeasibility of recruitment procedures, data collection and acceptability of the intervention.Secondary outcome measuresChanges in motivation, self-efficacy, opportunity to deprescribe paracetamol for their LBP, paracetamol usage and LBP clinical outcomes at baseline, 1-week and 1-month follow-up.ResultsA total of 24 participants were recruited into the study within the timeframe of 3 months from study advertisement and all completed the study follow-up. There were no missing data for any outcome measure across all follow-up points, 22 (91.6%) participants were willing to participate in a future randomised control trial (RCT) and over 60% of participants responded positively to questions regarding acceptability of the patient-educational booklet. Overall, at the 1-month follow-up, approximately two thirds (15/24) of participants had an increase in motivation and self-efficacy scores and had discussed or intended to discuss their paracetamol use for LBP with a health professional.ConclusionsThe results of this study demonstrate that the patient-education booklet is feasible to implement, and both the intervention and study design were well-received by participants. This study supports the undertaking an RCT to assess the effects of the patient-education booklet on deprescribing paracetamol in people with LBP.

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs.

Introduction Older adults living in the community often have multiple, chronic conditions and functional impairments. A challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning. Objective To predict survival time for older adults in the home care setting. The final mortality risk algorithm will be implemented as a web-based calculator that can be used by older adults needing care and by their caregivers. Design Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC) data in Ontario, Canada, from 1 January 2007 to 31 December 2013. Participants The derivation cohort will consist of ∼437 000 older adults who had an RAI-HC assessment between 1 January 2007 and 31 December 2012. A split sample validation cohort will include ∼122 000 older adults with an RAI-HC assessment between 1 January and 31 December 2013. Main outcome measures Predicted survival from the time of an RAI-HC assessment. All deaths (n≈245 000) will be ascertained through linkage to a population-based registry that is maintained by the Ministry of Health in Ontario. Statistical analysis Proportional hazards regression will be estimated after assessment of assumptions. Predictors will include sociodemographic factors, social support, health conditions, functional status, cognition, symptoms of decline and prior healthcare use. Model performance will be evaluated for 6-month and 12-month predicted risks, including measures of calibration (eg, calibration plots) and discrimination (eg, c-statistics). The final algorithm will use combined development and validation data. Ethics and dissemination Research ethics approval has been granted by the Sunnybrook Health Sciences Centre Review Board. Findings will be disseminated through presentations at conferences and in peer-reviewed journals. Trial registration number NCT02779309, Pre-results.