Objective. To compare the impact of conventional versus telemedicine follow-up of general surgery patients in outpatient clinics.
Design. Prospective randomized clinical trial.
Setting and participants. Participants were recruited from Hospital Germans Trias i Pujol, a tertiary care university hospital located in the outskirts of Barcelona (Catalonia, Spain). To be included in this study, participants had to have been treated in the general surgery department, have basic computer knowledge (ability to use e-mail or a social network), have a computer with webcam, and be 18 to 75 years of age, or they had to have a partner who met these criteria. Exclusion criteria included any disability making telemedicine follow-up impossible (eg, blindness, deafness, or mental disability; proctologic treatment; difficulty describing and/or showing complications in the surgical area; and clinical complications before discharge more severe than Clavien Dindo II), as well as withdrawal of consent. Patients who met the criteria and had just been discharged from the hospital were offered the opportunity to enroll by the surgeon in charge. Patients who agreed to participate provided informed consent and were assigned using a computerized block randomization list (allocation ratio 1:1).
Intervention. Time to visit was generally between 2 and 4 weeks after discharge (the interval to the follow-up visit was determined at the discretion of the treating surgeon, but always followed the usual schedule). To conduct the telemedicine follow-up through a video call, a medical cloud-based program fulfilling all European Union security and privacy policies was used. Four surgeons were assigned to perform the telemedicine visits and were trained on how to use the program before the study started. Visit format was the same in both groups: clinical and wound condition were assessed and pathology was discussed (the one difference was that physical exploration was not performed in the telemedicine group).
Main outcome measures. The primary outcome was the feasibility of telemedicine follow-up, and this was measured as the percentage of participants who completed follow-up in their corresponding group by the date scheduled at hospital discharge. Secondary outcomes included a comparison of clinical results and patient satisfaction. To assess the clinical results, extra visits to an outpatient clinic and/or the emergency department during the first 30 days after the follow-up visit were collected.
To evaluate patient satisfaction, a questionnaire was sent via email to the participants after the visit and, if they did not respond, a telephone survey was carried out (if there was no contact after 2 telephone calls, the participants was considered a missing value). The questionnaire was informed by the United Kingdom National Health Service outpatients questionnaire and the Telehealth Usability Questionnaire. It included 27 general questions asked of participants in both groups, plus 8 specific questions for participants in the conventional follow-up group and 14 specific questions for participants in the telemedicine group. To summarize all the included fields in the questionnaires (time to visit and visit length, comfort, tests and procedures performed before and during the visit, transport, waiting time, privacy, dealings with staff, platform usability, telemedicine, and satisfaction), participants were asked to provide a global satisfaction score on a scale from 1 to 5.
Analysis. To compare the groups in terms of proportion of outcomes, a chi-square test was used to analyze categorical variables. To compare medians between the groups, ordinal variables were analyzed using the Mann-Whitney U test. Statistical significance was set at P < 0.05.