How Frequently and in What Format Are Research Trial Results Disseminated to Participants (ResponseQT)

Study Overview
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Brief Summary
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Questionnaires are frequently used in online research, however recruiting, and completion rates of online participants from a variety of cultures and demographic backgrounds can be challenging. The challenge is greater in an online cohort because there is no way to observe the participant beyond what is contributed online. Poor recruiting and completion can result in underpowered research that may not be representative of the sample population. This can trigger an increase in costs as the recruitment period may have to be extended until sample size is reached. When recruiting and completion rates are inadequate studies may have to be terminated and the answer to the research question can remain unknown. To mitigate these challenges, reminder emails are sent to questionnaire respondents. There is uncertainty about how the tone of the email reminder affects the proportion of recruitment rates. A nested randomized trial will be used to test the intervention of tone delivery in survey email reminders to establish an evidence base. This study (ResponseQT) proposes to link with the anticipated 20,000 person international cohort study, (How Frequently and in What Format are Research Trial Results Disseminated to Participants: A Survey of Trialists (ResponseQT) to explore the evidence of effect for the research question, Does the tone of a survey email reminder affect the proportion of survey participants recruited. The population will consist of researchers who have published a clinical trial indexed in Pub Med in 2014-15.The intervention is the tone of questionnaire email reminders and the outcomes will be the proportion of participants recruited after invitation (partial plus complete responses) following reminder 1 and 2.

Detailed Description
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RATIONALE Dissemination is the planned process by which results of studies are communicated to the stakeholders of that research. Stakeholders can include health policy makers, academics, practicing clinicians and other health service workers, patients, the general public, and research funders. There are multiple ways to disseminate research findings and it is often considered a shared responsibility between funders and research investigators. Traditionally, the focus has targeted healthcare professionals, policy makers, and academics through journal publications and conference presentations. However, optimal knowledge translation depends on disseminating results to all stakeholders in a way that enables them to consider the implications of the results. Effective communication and active dissemination of research results to patients and the lay public is essential for making informed decisions and choices, but it is sometimes considered as an afterthought. Furthermore, there is no consensus on what dissemination to patients or members of the lay public means, what is the most effective dissemination process and whether research results should be disseminated to relevant patient groups and the wider public as well as the patients who took part in the studies. Only clinical trials indexed in PubMed 2014-15 where participants were enrolled into the study will be included. We will include screening questions at the start of the survey to exclude authors of non-randomised controlled trials, preclinical, and first-in-human trials and trials where there were no study participants. AIM To identify frequency and format of dissemination of clinical trial results to participants and to identify barriers to dissemination. OBJECTIVES To identify frequency of dissemination of recently published clinical trial results to participants; To explore the format of results disseminated to participants and describe researchers' perceived appropriateness and accessibility of the format; To identify how frequently research results are disseminated to patients beyond those taking part in the trials such as via advocacy groups; To explore the frequency of public/patient involvement for determining the format, content, and extent of the dissemination plans; To determine researchers' perceived confidence in disseminating results to participants and other patients. This research will contain a study within a study (SWAT) also known as a nested trial (ResponseQT). SWAT RATIONALE Written communication in questionnaire email reminders are without verbal or sensory cues and it is difficult to modify reminders without feedback from respondents. It would be helpful to know what kind of tone the researcher can take to increase recruitment rates. In questionnaires, the tone could be perceived as the perception of the researcher's attitude toward the reader and the subject of the message. The overall tone of a questionnaire reminder message may affect the reader just as one's tone of voice affects the listener in a verbal exchange. This could influence response and completion rates. Added to the complexity, tone can be interpreted differently by different individuals. Survey communications about reminders suggest two approaches appealing to a team victory with a sense of duty and benefit for others by participating or by building a sense of encouragement for participation. In addition, we will test whether introducing duty or encouragement in the second reminder (after a generic first reminder) makes a difference and whether someone who was exposed to duty or encouragement in the first reminder benefits from the reinforcement of a nudge from a generic reminder. METHODS This research involves exploring ways to increase recruitment rates through reminder emails that will be sent to those who were invited but have not yet responded to the questionnaire. A reminder will be sent to all non-respondents by email 14 days following the initial mailing. An additional reminder will be sent to all non-respondents by email 28 days following the first reminder. The nested trial (ResponseQT) will examine the evidence of effect for tone used within the questionnaire reminder emails. The group to which a participant is randomized will determine the tone of the questionnaire reminder emails. All potential respondents will be randomized to one of nine groups. They will receive the same questionnaire invitation email. Reminders for non-responders be assigned according to the group they were randomized to: Group A Tone = Duty x 2 Group B Tone = Encourage x 2 Group C Tone = Encourage + Duty Group D Tone = Duty + encourage Group E Tone = Generic tone reminders X 2 Group F Tone = Generic + Duty Group G Tone = Generic + Encouragement Group H Tone = Duty + Generic Group I Tone = Encouragement + Generic All non-responders will receive a reminder to complete the questionnaire at fourteen days according to the group they are randomized to. At twenty-eight days remaining non-responders will receive the second reminder email. The outcomes of recruitment will be compared at three stages: initial response, following the first reminder and following the second reminder.

Official Title
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How Frequently and in What Format Are Research Trial Results Disseminated to Participants? A Survey of Trialists and Response Questionnaire Trial

Conditions
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Motivation

Intervention / Treatment
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* Behavioral: Group A Reminder
* Behavioral: Group B Reminder
* Behavioral: Group C Reminder
* Behavioral: Group D Reminder
* Behavioral: Group E Reminder
* Behavioral: Group F Reminder
* Behavioral: Group G Reminder
* Behavioral: Group H Reminder
* Behavioral: Group I Reminder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: reports of clinical trials with human participants indexed in PubMed 2014-15 Exclusion Criteria: reports of laboratory or animal studies, reports of preclinical trials, reports of trials where there were no study participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Reminder<br>Tone of reminder email (duty 14 days followed by duty for non-responders 28 days) | Behavioral: Group A Reminder<br>* Tone of reminder email (duty 14 days followed by duty 28 days for non-responders)<br>|
| Active Comparator: Group B Reminder<br>Tone of reminder email (encouragement 14 days followed by encouragement for non-responders 28 days) | Behavioral: Group B Reminder<br>* Tone of reminder email (encouragement 14 days followed by encouragement 28 days for non-responders)<br>|
| Active Comparator: Group C Reminder<br>Tone of reminder email (encouragement 14 days followed by duty for non-responders 28 days) | Behavioral: Group C Reminder<br>* Tone of reminder email (encouragement 14 days followed by duty for non-responders 28 days)<br>|
| Active Comparator: Group D Reminder<br>Tone of reminder email (duty 14 days followed by encouragement for non-responders 28 days) | Behavioral: Group D Reminder<br>* Tone of reminder email (duty 14 days followed by encouragement for non-responders 28 days)<br>|
| Active Comparator: Group E Reminder<br>Tone of reminder email (generic reminders at 14 days followed by generic for non-responders 28 days) | Behavioral: Group E Reminder<br>* Tone of reminder email (generic reminders 14 days followed by 28 days for non-responders)<br>|
| Active Comparator: Group F Reminder<br>Tone of reminder email (generic 14 days followed by duty for non-responders 28 days) | Behavioral: Group F Reminder<br>* Tone of reminder email (generic 14 days followed by duty for non-responders 28 days)<br>|
| Active Comparator: Group G Reminder<br>Tone of reminder email (generic 14 days followed by encouragement for non-responders 28 days) | Behavioral: Group G Reminder<br>* Tone of reminder email (generic 14 days followed by encouragement for non-responders 28 days)<br>|
| Active Comparator: Group H Reminder<br>Tone of reminder email (duty 14 days followed by generic for non-responders 28 days) | Behavioral: Group H Reminder<br>* Tone of reminder email ( duty14 days followed by generic for non-responders 28 days)<br>|
| Active Comparator: Group I Reminder<br>Tone of reminder email (encouragement 14 days followed by generic for non-responders 28 days) | Behavioral: Group I Reminder<br>* Tone of reminder email (encouragement 14 days followed by generic non-responders 28 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Proportion of sample recruited | Duration of study up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dissemination, Tone, Survey reminders, Questionnaires