Assessing Patient Adherence to and Engagement With Digital Interventions for Depression in Clinical Trials: Systematic Literature Review.

BACKGROUND: New approaches to the treatment of depression are necessary for patients who do not respond to current treatments or lack access to them because of barriers such as cost, stigma, and provider shortage. Digital interventions for depression are promising; however, low patient engagement could limit their effectiveness. OBJECTIVE: This systematic literature review (SLR) assessed how participant adherence to and engagement with digital interventions for depression have been measured in the published literature, what levels of adherence and engagement have been reported, and whether higher adherence and increased engagement are linked to increased efficacy. METHODS: We focused on a participant population of adults (aged ≥18 years) with depression or major depressive disorder as the primary diagnosis and included clinical trials, feasibility studies, and pilot studies of digital interventions for treating depression, such as digital therapeutics. We screened 756 unique records from Ovid MEDLINE, Embase, and Cochrane published between January 1, 2000, and April 15, 2022; extracted data from and appraised the 94 studies meeting the inclusion criteria; and performed a primarily descriptive analysis. Otsuka Pharmaceutical Development & Commercialization, Inc (Princeton, New Jersey, United States) funded this study. RESULTS: This SLR encompassed results from 20,111 participants in studies using 47 unique web-based interventions (an additional 10 web-based interventions were not described by name), 15 mobile app interventions, 5 app-based interventions that are also accessible via the web, and 1 CD-ROM. Adherence was most often measured as the percentage of participants who completed all available modules. Less than half (44.2%) of the participants completed all the modules; however, the average dose received was 60.7% of the available modules. Although engagement with digital interventions was measured differently in different studies, it was most commonly measured as the number of modules completed, the mean of which was 6.4 (means ranged from 1.0 to 19.7) modules. The mean amount of time participants engaged with the interventions was 3.9 (means ranged from 0.7 to 8.4) hours. Most studies of web-based (34/45, 76%) and app-based (8/9, 89%) interventions found that the intervention group had substantially greater improvement for at least 1 outcome than the control group (eg, care as usual, waitlist, or active control). Of the 14 studies that investigated the relationship between engagement and efficacy, 9 (64%) found that increased engagement with digital interventions was significantly associated with improved participant outcomes. The limitations of this SLR include publication bias, which may overstate engagement and efficacy, and low participant diversity, which reduces the generalizability. CONCLUSIONS: Patient adherence to and engagement with digital interventions for depression have been reported in the literature using various metrics. Arriving at more standardized ways of reporting adherence and engagement would enable more effective comparisons across different digital interventions, studies, and populations.

Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update.

These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.

Identifying patients and clinical scenarios for use of long-acting injectable antipsychotics - expert consensus survey part 1.

OBJECTIVE: To assess expert consensus on barriers and facilitators for long-acting injectable antipsychotic (LAI) use and provide clinical recommendations on issues where clinical evidence is lacking, including identifying appropriate clinical situations for LAI use. METHODS: A 50-question survey comprising 916 response options was distributed to 42 research experts and high prescribers with extensive LAI experience. Respondents rated options on relative appropriateness/importance using a 9-point scale. Consensus was determined using chi-square test of score distributions. Mean (standard deviation) ratings were calculated. Responses to 29 questions (577 options) relating to appropriate patients and clinical scenarios for LAI use are reported. RESULTS: Recommendations aligned with research on risk factors for nonadherence and poor outcomes for patients with schizophrenia/schizoaffective or bipolar disorder. Findings suggested, contrary to general practice patterns, that LAI use may be appropriate earlier in the disease course and in younger patients. Results for bipolar disorder were similar to those for schizophrenia but with less consensus. Numerous facilitators of LAI prescribing were considered important, particularly that LAIs may reduce relapses and improve outcomes. CONCLUSION: Findings support wider use of LAIs in patients with schizophrenia/schizoaffective and bipolar disorders beyond the setting of poor adherence and earlier use in the disease course.

Initiating/maintaining long-acting injectable antipsychotics in schizophrenia/schizoaffective or bipolar disorder - expert consensus survey part 2.

OBJECTIVE: The aim of this study was to provide recommendations on initiating and maintaining long-acting injectable antipsychotics (LAIs) in individuals with schizophrenia/schizoaffective or bipolar disorder. METHODS: A 50-question survey comprising 916 response options was completed by 34 expert researchers and high prescribers with extensive LAI experience, rating relative appropriateness/importance on a 9-point scale. Consensus was determined using chi-square test of score distributions. Results of 21 questions comprising 339 response options regarding LAI initiation, maintenance treatment, adequate trial definition, identifying treatment nonresponse, and switching are reported. RESULTS: Experts agreed that the most important LAI selection factor was patient response/tolerability to previous antipsychotics. An adequate therapeutic LAI trial was defined as the time to steady state ± 1-2 injection cycles. Experts suggested that oral efficacy and tolerability should be established before switching to an LAI, without consensus on the required time, and that the time for oral supplementation and next injection interval should be determined by the time to attainment of therapeutic LAI levels. Most experts agreed that ≥1 adequate LAI trial is needed to identify the lack of efficacy. There was little agreement about strategies for switching between LAIs. CONCLUSION: Expert guidance may aid clinicians in their decisions regarding initiating/maintaining LAIs in individuals with schizophrenia/schizoaffective or bipolar disorder.

Digital health technology for use in patients with serious mental illness: a systematic review of the literature.

BACKGROUND: As the capabilities and reach of technology have expanded, there is an accompanying proliferation of digital technologies developed for use in the care of patients with mental illness. The objective of this review was to systematically search published literature to identify currently available health technologies and their intended uses for patients with serious mental illness. MATERIALS AND METHODS: The Medline, Embase, and BIOSIS Previews electronic databases were searched to identify peer-reviewed English language articles that reported the use of digital, mobile, and other advanced technology in patients with schizophrenia/schizoaffective disorder, bipolar disorder, and major depressive disorder. Eligible studies were systematically reviewed based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Eighteen studies that met the inclusion criteria were identified. Digital health technologies (DHTs) assessed in the selected studies included mobile applications (apps), digital medicine, digital personal health records, and an electronic pill container. Smartphone apps accounted for the largest share of DHTs. The intended uses of DHTs could be broadly classified as monitoring to gain a better understanding of illness, clinical assessment, and intervention. Overall, studies indicated high usability/feasibility and efficacy/effectiveness, with several reporting validity against established clinical scales. Users were generally engaged with the DHT, and mobile assessments were deemed helpful in monitoring disease symptoms. CONCLUSION: Rapidly proliferating digital technologies seem to be feasible for short-term use in patients with serious mental illness; nevertheless, long-term effectiveness data from naturalistic studies will help demonstrate their usefulness and facilitate their adoption and integration into the mental health-care system.

Attitudes toward antipsychotic treatment among patients with bipolar disorders and their clinicians: a systematic review.

INTRODUCTION: Antipsychotics are recommended as first-line therapy for acute mania and maintenance treatment of bipolar disorder; however, published literature suggests their real-world use remains limited. Understanding attitudes toward these medications may help identify barriers and inform personalized therapy. This literature review evaluated patient and clinician attitudes toward the use of antipsychotics for treating bipolar disorder. MATERIALS AND METHODS: A systematic search of the Cochrane Library, Ovid MEDLINE, Embase, and BIOSIS Previews identified English language articles published between January 1, 2000, and June 15, 2016, that reported attitudinal data from patients, health care professionals, or caregivers; treatment decision-making; or patient characteristics that predicted antipsychotic use for bipolar disorder. Results were analyzed descriptively. RESULTS: Of the 209 references identified, 11 met the inclusion criteria and were evaluated. These articles provided attitudinal information from 1,418 patients with bipolar disorder and 1,282 treating clinicians. Patients' attitudes toward antipsychotics were generally positive. Longer duration of clinical stability was associated with positive attitudes. Implementation of psychoeducational and adherence enhancement strategies could improve patient attitudes. Limited data suggest clinicians' perceptions of antipsychotic efficacy and tolerability may have the greatest impact on their prescribing patterns. Because the current real-world evidence base is inadequate, clinician attitudes may reflect a relative lack of experience using antipsychotics in patients with bipolar disorder. CONCLUSION: Although data are very limited, perceived tolerability and efficacy concerns shape both patient and clinician attitudes toward use of antipsychotic drugs in bipolar disorder. Additional studies are warranted.