CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "Participants randomized to the intervention received an enhanced (uploading) pedometer and had access to a website that provided automated walking goals, feedback, motivational messages and social support through an e-community (n = 111). Usual care participants (n = 118) also received the enhanced pedometer but did not receive the automated feedback or have access to the website." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Not reported in abstract. The intervention was mostly automated but human/staff involvement, such as posting on e-community forum and follow-up of reported potential adverse events, is described in the methods section of the manuscript. 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "229 Veterans with non-specific chronic back pain were recruited from one Department of Veterans Affairs (VA) healthcare system." "Outcomes, including the primary outcome, the Roland Morris Disability Questionnaire (RDQ), were measured at baseline, 6 months and 12 months using a survey administered through the study website." 1b-iv) RESULTS section in abstract must contain use data "Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months." Number of enrolled participants in each group is described in the methods section of the abstract: "Participants randomized to the intervention received an enhanced (uploading) pedometer and had access to a website that provided automated walking goals, feedback, motivational messages and social support through an e-community (n = 111). Usual care participants (n = 118) . . ." 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Although there were no differences at 12 months (the primary endpoint for the trial), the interim 6 months results were generally positive. So, while not addressed in the abstract, information about uptake is included in the manuscript. INTRODUCTION 2a-i) Problem and the type of system/solution Pg. 5 "Exercise therapy has proven benefits for managing chronic back pain [12-14]. Specifically, exercise and staying active can prevent recurrence, reduce pain, improve function, and decrease disability for patients with chronic back pain [12, 13, 15-19]. However, there are few efficient and effective strategies to help patients engage in exercise therapy for managing their chronic low back pain." 2a-ii) Scientific background, rationale: What is known about the (type of) system Pg 5. "Internet-based programs are an increasingly popular option for promoting healthy behaviors, such as those related to diet and exercise, and for delivering behavior change interventions [20-22]. Studies have shown that the Internet can be used to successfully promote weight loss [23], increase physical activity [24] and improve patient self activation [25] or self-management behaviors [20]. Yet, only a few studies have focused specifically on patients with chronic pain [25, 26] and none have focused primarily on exercise to reduce pain-related disability and improve patient function." METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio Pg 5. "We conducted a randomized trial to investigate whether a pedometer-based, Internet-mediated intervention designed to assist patients with initiating and maintaining a regular walking program, would reduce pain-related disability and functional interference among patients with chronic back pain at 6 months and over a 12-month timeframe." 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Pg 6. "There were no significant changes in methods following study initiation." 3b-i) Bug fixes, Downtimes, Content Changes No applicable. Although there were some minor technical issues encountered throughout the course of the study there were no significant issues or any major downtime affecting the delivery of the intervention or study results. 4a) CONSORT: Eligibility criteria for participants Pg 6. "Participants were recruited from one VA Healthcare System between May 2009 and March 2011. Eligible participants were age 18 or older and identified through provider referrals to back class and use of the VA electronic medical record system. Specifically, we identified patients who had two or more outpatient encounters in the prior 12 months with a diagnosis of back pain with no neurologic findings (ICD-9-CM codes 724.2, 724.5, 846.0846.9). Study staff screened potential participants by phone or in person. Eligibility criteria included: 1) persistent back pain > 3 months; 2) sedentary lifestyle (< 150 minutes of physical activity per week); 3) weekly access to a computer with a USB port and Internet access; 4) ability to provide written informed consent and communicate in English; 5) community residence; 6) ability to walk at least one block; and 7) report they are not pregnant. Prior to participation, all eligible patients had to attend back class and obtain medical clearance." 4a-i) Computer / Internet literacy Pg 6. "Eligibility criteria included: 1) persistent back pain > 3 months; 2) sedentary lifestyle (< 150 minutes of physical activity per week); 3) weekly access to a computer with a USB port and Internet access;. . ." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: