Original Title: [Automatiserad återkoppling baserad på digital uppföljning av patienter med unipolär depression som behandlas med läkemedel]

Authors' objectives: Background Patients with unipolar depression are often treated pharmacologically. Continuous follow-up is recommended as treatment adjustments may be needed and, in case of remission, for tapering off the medication. Follow-up routines vary substantially between healthcare units in Sweden. In this context, digitalized follow-up – i.e. collecting patient data on, for instance, depressive symptoms, medication adherence et cetera, and transferring this information to the healthcare unit – is considered an opportunity, in particular if accompanied by an automated protocol to limit the need for clinical staff resources and to highlight information that needs the attention of staff. Question at issue In adults with unipolar depression receiving pharmacotherapy, does automated digitalized follow-up alone or in addition to treatment as usual compared with follow-up without such digitalized follow-up (treatment as usual or other comparator) result in improvement regarding depressive symptoms, health-related quality of life (HrQoL), reduced suicidal behaviour, complications, everyday functioning, duration of sick leave, patient reported experience, number of healthcare visits, adherence to medication, or system usability?

Authors' results and conclusions: Results No studies were identified comparing automated digitalized follow-up with treatment as usual in patients receiving pharmacological treatment due to unipolar depression. A single RCT with 120 patients, recently discharged after hospitalization due to a unipolar depressive episode, compared smartphone-based monitoring in addition to treatment as usual with treatment as usual alone. All patients in the study were included after discharge from hospitalization due to a unipolar depressive disorder and can be considered a sub-group regarding severity of depression. The study was considered to have major limitations regarding directness, as well as very serious study limitations and serious imprecision regarding the outcomes of interest in this report. The outcomes depressive symptoms, HrQoL, number of healthcare visits (studied in terms of rehospitalization), adherence to medication, and everyday functioning were evaluated in the RCT. There were no statistically significant differences between the treatment groups for any of the studied outcomes. It is uncertain whether there is any difference regarding these outcomes between digitalized follow-up provided in addition to treatment as usual, compared with treatment as usual alone (GRADE ⊕). No data were reported on suicidal behaviour, complications, duration of sick leave, patient reported experience, and system usability (ease of use). Costs and ethical aspects The broad search in this project revealed that there can be a wide variety of systems for automated digital follow-up of the patient population. Up to now, there is no established plan for what kind of system could be considered for use in Region Västra Götaland. Further, the scientific evidence identified in this HTA-project is very limited. Therefore, detailed analyses of costs and of ethical aspects were not considered feasible at this point. Development and use of systems in this area need to consider the vulnerability of the targeted population, and special attention needs to be paid to ensuring data integrity. Conclusion The use of automated digitalized follow-up instead of standard follow-up visits for these patients has not been studied. Based on very low certainty of evidence from one RCT in patients receiving pharmacotherapy due to unipolar depression, it is uncertain whether adding automated digitalized follow-up to treatment as usual results in any difference regarding depressive symptoms, HrQoL, number of healthcare visits, adherence to medication, and everyday functioning. No data regarding suicidal behaviour, complications, duration of sick leave, patient reported experience, and system usability were reported.

Authors' methods: Database searches in Medline, Embase, the Cochrane Library and APA PsycINFO were performed on May 5th, 2023. Titles and abstracts, and subsequently full text articles, were independently screened by at least two authors, and final inclusion was decided in consensus amongst all authors. Included studies were critically appraised, and data were extracted. For outcomes and pre-specified subgroups (by severity of depression, age, intensity of follow-up) where comparative data were available, certainty of evidence was assessed using the GRADE approach.

Project Status: Completed

Year Published: 2024

URL for published report: https://mellanarkiv-offentlig.vgregion.se/alfresco/s/archive/stream/public/v1/source/available/sofia/su4372-2081313122-147/native/2024_137%20HTA-rapport%20Automated%20digital%20short%20term%20follow%20up%20of%20change%20in%20antidepressive%20treatment%202024-05-22.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Organisation Name: The Regional Health Technology Assessment Centre

Contact Address: The Regional Health Technology Assessment Centre, Region Vastra Gotaland, HTA-centrum, Roda Straket 8, Sahlgrenska Universitetssjukhuset, 413 45 GOTHENBORG, Sweden

Contact Name: hta-centrum@vgregion.se

Contact Email: hta-centrum@vgregion.se