Evidence map›Paper›PMID 27876689›Full record

Trial reportJournal of medical Internet research2016

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

Trygve Skonnord, Finn Steen, Holgeir Skjeie, Arne Fetveit, Mette Brekke, Atle Klovning

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Trygve SkonnordInstitute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.ORCID 0000-0003-4816-076X
Finn SteenCentre for Medical Web Research, Hong Kong, China.ORCID 0000-0002-4031-3226
Holgeir SkjeieInstitute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.ORCID 0000-0002-7586-8651
Arne FetveitInstitute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.ORCID 0000-0001-8566-1972
Mette BrekkeInstitute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.ORCID 0000-0003-3454-2329
Atle KlovningInstitute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.ORCID 0000-0002-2917-1845

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElectronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points.

objectiveOur aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points.

methodsThe first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries.

resultsWe have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage.

conclusionsThe SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings.

Indexed as

Electronic MailInternetText MessagingAdultData CollectionFemaleHumansMalePilot ProjectsSurveys and Questionnairesdata collectionemailInternetquality improvementrandomized controlled trialssample sizesurveys and questionnairestext messaging

Identifiers

PMID27876689
PMCPMC5141334

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.