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• The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. • Improvements on severity of symptoms in both groups suggest that the self-care program using a mobile app or a paper book may be beneficial in individuals with fibromyalgia. • The Sleep Strategies was the most used function of the ProFibro app, followed by the Exercise Program, and the diary for the practice of gratitude. The ProFibro application (app) was developed as a Mobile Health resource to promote self-care in fibromyalgia management. This study aimed to assess the effects of the use of the ProFibro app for six weeks compared to the use of a traditional paper book of similar content to improve health-related quality of life, symptoms, and self-care agency in individuals with fibromyalgia. Forty individuals with fibromyalgia were included in this randomized, single-blind, parallel trial. One group received intervention content using the ProFibro app on a smartphone while the other received similar information using a paper book. Participants were assessed at baseline and after six weeks. The primary outcome was the Revised Fibromyalgia Impact Questionnaire. Secondary outcomes were Widespread Pain Index, Pain Visual Analog Scale, Symptom Severity Scale, and Appraisal of Self-Care Agency Scale – Revised. No differences in changes were found between groups at the end of the treatment for any outcome. Both groups showed improvements in symptom severity. The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. Both groups showed improvements from baseline on severity of symptoms, suggesting that the self-care program using a mobile app or a paper book may be beneficial for individuals with fibromyalgia. [ABSTRACT FROM AUTHOR]

• We will monitor compliance with the intervention and adverse events. • Data will be analyzed following intention-to-treat principles. • A cost-effectiveness analysis will be performed. This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. This paper will provide a detailed description of the planned analyses for the TOPS trial. Australian New Zealand Clinical Trials Registry (ACTRN12615000939594). [ABSTRACT FROM AUTHOR]