Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials

Skonnord, Trygve; Steen, Finn; Skjeie, Holgeir; Fetveit, Arne; Brekke, Mette; Klovning, A.

doi:10.2196/jmir.6560

Cited by 10 publications

(20 citation statements)

References 18 publications

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“…Pawar et al found Software version of Roland Morris Disability questionnaire was comparable to the paper version in patients with low back pain [42]. While, other researchers found web or mobile device-based systems could facilitate consecutive patient data collection in RCTs and can be used to increase response rates and quality of research [43,44]. Future studies should consider applying electronic tools to simplify the follow-up process and reduce loss to follow-up.…”

Section: Discussionmentioning

confidence: 99%

The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial (Preprint)

Hou¹,

Yang²,

Yang³

et al. 2018

Preprint

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Background:Rehabilitation is very important for postoperative patients with low back pain. However, the promotion of traditional clinic-based program is limited in developing countries like China, due to the maldistribution of medical resources. Smartphones may be a potential substitute for those who have no access to traditional rehabilitation. Objective:The aim of this study was to examine the efficacy of a smartphone based rehabilitation system in patients accepted lumbar spinal operation. Methods:Postoperative patients with low back pain were recruited and randomized to rehabilitation treatment provide by smartphone based e-health program (EH) or usual care treatment (UC) as control group. Primary outcomes were function and pain status assessed by Oswestry Disability Index (ODI) and visual analogue scale (VAS). Secondary outcomes were general mental health and life status (Likert scales, EQ-5D and SF-36). All the patients were assessed pre-operatively and then at 3, 6, 12 and 24 months post-operatively. ResultsA total of 168 of the 863 eligible patients were included and randomized in this study. The analysis showed that the improvement in EH group was superior to UC group at 24 months postoperatively (mean difference: ODI 7.02, SD 3.1, P<0.05; VAS 7.59, SD 3.42, P<0.05). No significant difference of primary outcomes was found at the other time points. Subgroup analysis showed that the improvements of the primary outcomes were more significant in those considered as high compliance in the EH group throughout the trial, compared with the UC group at 6, 12 and 24 months. Conclusion:This research demonstrated that E-health, a smart phone based tele-rehabilitation system can be an effective rehabilitation tool in self-management for postoperative patient with low back pain.The effectiveness of E-health was more evident in high adherent participants. Still, more researches are needed to understand factors associated with patients' adherence.Trial Registration: Chinese clinical trial registry, ChiCTR-TRC-13003314,

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Section: Discussionmentioning

confidence: 99%

The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial (Preprint)

Hou¹,

Yang²,

Yang³

et al. 2018

Preprint

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“…Many studies use reminder messages to maximize response rates [1,11,26,27]. Nippita et al sent text messages daily at 9 pm and a reminder message 12 h later if the first message went unanswered [1].…”

Section: The Datamentioning

confidence: 99%

Best practices for collecting repeated measures data using text messages

Shimoni

Nippita

Castaño

2020

BMC Med Res Methodol

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Background: Researchers and clinicians use text messages to collect data with the advantage of real time capture when compared with standard data collection methods. This article reviews project setup and management for successfully collecting patient-reported data through text messages. Methods: We review our experience enrolling over 2600 participants in six clinical trials that used text messages to relay information or collect data. We also reviewed the literature on text messages used for repeated data collection. We classify recommendations according to common themes: the text message, the data submitted and the phone used. Results: We present lessons learned and discuss how to create text message content, select a data collection platform with practical features, manage the data thoughtfully and consistently, and work with patients, participants and their phones to protect privacy. Researchers and clinicians should design text messages to include short, simple prompts and answer choices. They should decide whether and when to send reminders if participants do not respond and set parameters regarding when and how often to contact patients for missing data. Data collection platforms send, receive, and store messages. They can validate responses and send error messages. Researchers should develop a protocol to append and correct data in order to improve consistency with data handling. At the time of enrollment, researchers should ensure that participants can receive and respond to messages. Researchers should address privacy concerns and plan for service interruptions by obtaining alternate participant contact information and providing participants with a backup data collection method. Conclusions: Careful planning and execution can reward clinicians and investigators with complete, timely and accurate data sets.

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“…Usually, the forms are distributed to the public through the mail or via censuses 3,5 . However, with the rise of the internet and the advent of electronic social networks, such as Facebook™ in 2004, distances to the target population were shortened, especially in Brazil 1,5,[7][8] . Studies have assessed the acceptability and representability of social networks in information science in Brazil 1 , which led researchers to apply electronic surveys more often 3,5,8 .…”

Section: Introductionmentioning

confidence: 99%

“…However, with the rise of the internet and the advent of electronic social networks, such as Facebook™ in 2004, distances to the target population were shortened, especially in Brazil 1,5,[7][8] . Studies have assessed the acceptability and representability of social networks in information science in Brazil 1 , which led researchers to apply electronic surveys more often 3,5,8 . In addition, the SciELO organization (online library) held a seminar in 2012 on the use of social networks in scientific communication, emphasizing the importance of this communication vehicle 1,2,[7][8] .…”

Section: Introductionmentioning

confidence: 99%

“…Studies have assessed the acceptability and representability of social networks in information science in Brazil 1 , which led researchers to apply electronic surveys more often 3,5,8 . In addition, the SciELO organization (online library) held a seminar in 2012 on the use of social networks in scientific communication, emphasizing the importance of this communication vehicle 1,2,[7][8] .…”

Section: Introductionmentioning

confidence: 99%

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The use of social networks in scientific research with questionnaires

et al. 2018

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Aim: The aim of this study was to determine the response rate of the SF-36 quality of life questionnaire sent and received by mail and over a social network to caregivers of individuals with epidermolysis bullosa (EB) in Brazil. Methods: All volunteers were first-degree relatives of patients with EB that directly spent time helping them with their basic activities of daily living. A maximum of two caregivers per patient could answer the questionnaire. Volunteers were divided into two groups: for group 1, questionnaires were sent to 53 members of a support association for the disease by mail, and for group 2, 798 members of the Facebook™ page of friends and relatives of patients with EB were invited to participate using an access link to Google Drive™ to gain access to the questionnaire. The data from both groups were analyzed 150 days after the start the study. Descriptive analysis was performed by EpiInfo8 and the return of questionnaires was evaluated according to age, sex, and time of return using the Chi-squared and Fisher’s exact test. Results: After 150 days, 30 questionnaires were returned, 17 (56.7%) of which from group 1 and 13 (43.3%) from group 2. Approximately 12 questionnaires were returned by mail and 11 over the social network. Conclusions: The data collection of the SF-36 quality of life questionnaire from caregivers of individuals with EB over a social network seems to be efficient mainly when it is necessary to collect results within a short timeframe, highlighting the importance of social networks as a means for conducting this type of research. However, in our study, the most efficient method was distributing the questionnaires by mail.

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Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials

Cited by 10 publications

References 18 publications

The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial (Preprint)

The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial (Preprint)

Best practices for collecting repeated measures data using text messages

The use of social networks in scientific research with questionnaires

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