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Table 2 Data sources used to explore the feasibility domains: (1) Recruitment and consent, (2) Intervention Uptake: “On-boarding”, (3) Intervention Adherence: “Completeness of symptom tracking”, (4) Outcome measurement

From: Preparing to deliver a stepped wedge cluster-randomised trial to test the effectiveness of daily symptom tracking integrated into electronic health records for managing rheumatoid arthritis: a mixed-methods feasibility trial

Data source

Description

Feasibility Domains

(1)

(2)

(3)

(4)

Screening/recruitment logs

Screening and recruitment logs were provided by sites, detailing the number and outcome of patient approaches, and reasons for ineligibility or declining participation.

X

   

Quantitative data on registration rates (via app records)

Registration logs (including study identifier and date of registration) were obtained from the app records and used to calculate the rate of registration.

 

X

  

Quantitative data on adherence rates (via app records)

App records provided information about all symptoms reported by participants each day, linked to their study identifier. Participants were considered to have “engaged” with the app on a day on which they provided at least one of the 8 daily symptom reports (see ‘Intervention’ description for more detail).

  

X

 

Quantitative data on availability of disease activity at baseline/follow-up (via EHR extraction)

A comprehensive selection of data was extracted from the participants’ EHRs and inputted into a secure study-specific database. Of interest here are disease activity data only.

   

X

Healthcare professional reported symptom data use (questionnaire)

A brief survey recorded healthcare professionals use of the REMORA data within their consultation, including information about when they looked at the data, whether they looked at the data with the patient and how useful the data were. A free-text box was provided for any additional comments regarding how data were used during the consultation.

  

X

 

Interviews with patients or clinicians

One-to-one semi-structured interviews (duration 7–35 min) took place by telephone, face-to-face, or using video-conferencing software, depending on participant preference.

Discussion topics included the use of technology for health monitoring in general and, where applicable:

 1. perceptions of the REMORA system

 2. the impact of REMORA system and tracked symptom data on the clinical consultation and decision making

 3. reasons for their (lack of) adherence with symptom tracking

 4. reasons for declining participation in the study, or for not completing on-boarding

X

X

X

 

Observations

Observations (duration 12 to 36 min) of consultations.

  

X

X

Study team logs

Study team logs comprised field notes from interviews, observations and summaries of contact/correspondence with participants or site staff via phone or email.

X

X

X