Survey Email Scheduling And Monitoring in eRCTs (SESAMe): a digital tool to improve data collection in clinical trials. Trygve Skonnord, Finn Steen, Arne Fetveit, Mette Brekke, Holgeir Skjeie, Atle Klovning Hello. My name is Trygve Skonnord. I am a GP from Norway and I am also doing some research through the University of Oslo. Now I will tell you about a software we have developed during the research and why we think this might be useful for other clinical researchers. The program is called SESAMe, an acronyme for Survey Email Scheduling And Monitoring in eRCTs.

Background The data do not allow firm conclusions… …because of small sample sizes and low methodological quality of the studies. …there is a further need for higher quality trials in this area. We have all heard about the problem with missing documentation for a lot of different treatments. To example; the Cochrane review about my own field, acupuncture and acute low back pain, concludes that there are too small sample sizes and low quality of the studies.

My first trial – paper questionnaires In my first trial, leaded by my good colleague Holgeir Skjeie, we asked parents to children with infantile colic to register the crying in diaries.*** The data collection was difficult because the paper questionnaires were lost – and *** even burned in the fireplace… ***

The Acuback-study Skonnord, Skjeie, Brekke, Grotle, Lund, Fetveit My own project is called the Acuback study, and we aim to explore whether acupuncture contribute to faster recovery when given in addition to the usual treatment in general practice.

270 * 19 = 5130 To not risk to burn all my data, I decided to use electronic questionnaires in the Acuback trial.*** I need to include 270 participants in the study. *** Each person will answer 19 surveys, *** and that makes over 5000 emails that need to be sent out. So - this process has to be automated. However I did not find any program that could do that.

Objectives We aimed to develop software that would automate the sending of emails with links to electronic surveys, and thereby improve data collection. We had to ask ourselves: Is it possible to develop a tool that can schedule emails to trial participants who are included at different points of time?

Method – The Excel version Well, we did. The first version of the software was tested in a pilot study in November 2013. We experienced several limitations, and concluded that we needed an online solution.

Method – The web version We then developed the web version of the program, which now is used in the main study that started in March 2014. *** The software schedules and sends the required emails to the participants, after a given template for each trial .

Questionnaires in LimeSurvey We use electronic questionnaires in the Open Source software LimeSurvey, which allows the interaction with our own program.

Monitoring function – The Survey Report The SESAMe software has a monitoring function – with a Survey Report that keep you updated with all your surveys; telling how many participants have completed each survey.

Monitoring - The Respondent Report The Respondent Report tells you who has not answered the surveys in a given time. *** You can then have a overview of the answering history for the scheduled surveys for each participant, with possibilities for both automatic and manual reminders. *** The reminders can be sent by either email or SMS - like here.

Improved response rate when installing reminder function 76% Improved response rate when installing reminder function 93% We have measured the response before and after the installing of the reminder function. The columns in this figure represent each of the questionnaires and each row show the response from the participants. Missing data is marked with yellow. The response rate has improved from 76 to 93%, which we consider is both significant and relevant.

Conclusion The SESAMe software is a digital tool that improves the response rate and the quality of data collection in clinical trials. This might be useful for other researches and can open doors to conducting larger RCTs with sufficient sample sizes. So – we have made a software that eases the logistics of trials by automating and monitoring data collection, and this contributes to improved response rate. We think that this might be useful for other researchers so that they can carry out larger RCTs with sufficient sample sizes.

Thank you for your attention! Open Sesame! If you are interested in this topic, you are very welcome to take contact with me after the presentation or on email. Thank you very much! Contact info: trygvets@uio.no