Treatment Adherence Research Articles

Effectiveness and prediction of treatment to guided internet-based cognitive behavioural therapy for health anxiety: A cohort study in routine psychiatric care

ObjectiveHealth anxiety, also known as hypochondriasis, is a common psychiatric disorder which leads to considerable distress and is associated with high societal costs. Internet-based cognitive behavioural therapy (ICBT) for health anxiety has demonstrated efficacy in randomized controlled trials (RCTs), but there is limited knowledge regarding its effectiveness in real-world settings. This study aimed to evaluate the clinical effectiveness of guided ICBT for health anxiety in routine psychiatric care, including symptom change, treatment adherence, and potential negative effects. Additionally, we explored predictors of treatment adherence. MethodA longitudinal cohort study of 447 patients enrolled in 12 weeks of ICBT for health anxiety between 2018 and 2020 in an outpatient psychiatric clinic specializing in ICBT. Primary outcome measure was the 14-item Short Health Anxiety Inventory (SHAI-14) and a within-group design with repeated measures was utilized for the primary analysis. ResultsParticipants showed significant improvements from pre- to post-treatment (d = 1.61). At post-treatment, 60 % (95 % CI 58–62) demonstrated statistically reliable change (RCI), and 44 % (95 % CI 42–46) were in remission. On average, participants completed 7 (SD = 4) out of 12 treatment modules. For each additional completed module, the mean reduction was 0.31 (95 % CI 0.10 to 0.54) points on the SHAI-14. ConclusionsGuided ICBT for health anxiety can be effective when delivered within the context of routine psychiatric care. The study suggests that effect sizes are comparable with those in RCTs and higher treatment adherence is associated with better outcomes in health anxiety. ICBT could be used to increase availability to effective therapy for health anxiety.

Developing STEP-SE: A Qualitative Usability Study of a Novel Patient-Reported Outcomes Tool for Managing Side Effects in Shared Decision-Making for Schizophrenia Spectrum Disorder Care.

Schizophrenia treatment with antipsychotics often results in side effects that impact adherence and quality of life. Managing these effects remains challenging, as it requires balancing efficacy and tolerability. The Schizophrenia Technological Evaluation of Patient Side Effects (STEP-SE) app aims to aid side effects monitoring and management through shared decision-making (SDM). This study aimed to evaluate the usability of the STEP-SE app for patients and clinicians in managing antipsychotic side effects. Sixteen stable outpatients and 14 psychiatrists participated in semi-structured interviews after using the STEP-SE app. Questions explored ease of use, information clarity, user needs fulfilment, patient-clinician collaboration, treatment adherence improvement, patient empowerment and clinical utility. Data were analysed thematically. Overall satisfaction with STEP-SE was high. Both groups found that the tool improved patient involvement, provided reliable information to enhance therapeutic alliance, posed low risks of misunderstanding and had an intuitive interface. Patients felt more motivated and empowered. Clinicians appreciated guideline consistency. Preferences differed regarding data visualization formats. STEP-SE shows potential for aiding SDM on antipsychotic side effects. Patients gained motivation, and clinicians felt reassured. Refinements around mobile access, graphics and features could augment utility. Generalizability is limited given the stable patient sample. Preliminary findings suggest that STEP-SE effectively engages patients, empowers them and supports clinicians in collaborative side effect management. Further testing with diverse user groups is warranted. The current study was designed to gather patient and public feedback for the development of our decision aid tool, STEP-SE. Participants interacted with the tool's prototype in interactive sessions, providing insights and identifying technical issues. Their feedback was crucial for enhancing the tool, with each suggestion and bug report carefully considered for future iterations. The participants' contributions were key in optimizing STEP-SE's features and ensuring its relevance and reliability. We thank all who shared their time and perspectives, significantly shaping the tool's user-centred design.

The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy

BackgroundEpilepsy is a common, chronic pediatric neurological condition predominately treated with anti-seizure medications (ASMs) to control or reduce seizures. Approximately 60 % of youth with epilepsy demonstrate suboptimal adherence to their ASM. This paper describes the methodology, recruitment, design, and baseline participant characteristics of a sequential, multiple assignment, randomized trial (SMART) designed to test the effectiveness of a behavioral health intervention to improve adherence in families of young children with epilepsy. MethodsUsing a two-stage SMART, youth ages 2–12 years old with newly diagnosed epilepsy and their families were enrolled. Following an 8-week run-in phase, families with ≤95 % adherence were randomized to control (education + automated digital reminders) or intervention (education + automated digital reminders + individualized feedback) arms. After three months, families in the intervention group who remained non-adherent (i.e., ≤ 95 %) were re-randomized to 1) continue with same intervention or 2) receive two telehealth problem-solving sessions with an interventionist over the next two months. Study measures were completed at baseline, 8-, 14-, and 20-months post-baseline. ResultsOf the n = 466 ethnically and racially diverse study participants, n = 268 participants were non-adherent and were randomized. The primary outcome was electronically monitored ASM adherence at post-intervention, while secondary outcomes included seizure freedom, health care utilization, and epilepsy-specific health-related quality of life. ConclusionsNovel aspects of the trial design (e.g., sequential, recruitment of racial and ethnic diverse youth), modifications to the protocol related to the COVID-19 pandemic and evolving socio-political and medical climate, as well as recruitment and retention challenges are discussed.ClinicalTrials.gov Number: NCT03817229

The Real-world Effect of Long-acting Injectable Antipsychotics on Annual Medical Costs of Korean Schizophrenia Patients.

Schizophrenia is a severe and chronic mental disorder that significantly impacts cognitive, social, and occupational functions, leading to substantial economic burdens. Long-acting injectable (LAI) antipsychotics have been introduced to improve treatment adherence and outcomes, yet their economic impact remains debated. We aim to analyze the impact of LAIs on the medical costs of Korean schizophrenia patients. A retrospective analysis of 164 schizophrenia patients treated with LAI antipsychotics, paliperidone palmitate, and aripiprazole monohydrate at Korea University Guro Hospital between January 2017 and July 2022 was performed. Comparisons of inpatient department (IPD) and outpatient department (OPD) healthcare expenditures one year before and after LAI initiation were conducted. LAIs led to an increase in annual OPD costs (1,437.44 ± 1,127.60 to 4,015.42 ± 1,204.59; units: 1,000 KRW) but significantly reduced IPD admission associated costs (3,826.06 ± 5,500.63 to 698.06 ± 3,619.38; units: 1,000 KRW). After LAI administration, there was an overall reduction in total annual healthcare costs (5,263.49 ± 5,333.11 to 4,713.48 ± 3,625.89; units: 1,000 KRW), but it was not statistically significant. Although the use of LAIs did not significantly lower the first-year medical costs of schizophrenia patients, they offer beneficial economic impacts over time by reducing hospitalization-associated costs. Future research should focus on long-term cost analyses and the impacts of newer LAI formulations.

Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants with Moderate-to-Severe Acne: The Patient Journey

Introduction: The main goal of acne treatment is to clear lesions quickly to manage and/or mitigate sequelae. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In three published clinical studies of participants with moderate to severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. Herein are presented detailed efficacy and safety data from 5 clinical study patients to document their CAB treatment journey. Methods: In two phase 3 (NCT04214652, NCT04214639), double-blind, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and percent change from baseline in inflammatory/ noninflammatory lesion counts. Dosing compliance, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. Descriptive data from 5 selected cases who completed 12 weeks of CAB treatment are summarized. Results: Participants (n=5) ranged from 13-32 years. At week 12, 3 achieved treatment success, 1 achieved a 2-grade reduction from severe to mild, and 1 achieved a 1-grade reduction from moderate to mild. Reductions from baseline to week 12 in inflammatory/ noninflammatory lesion counts ranged from 74.7-100%. No participants reported TEAEs/serious AEs. Some cutaneous safety/tolerability scores increased at weeks 2, 4, or 8, but generally decreased back to/below baselines levels by week 12, similar to the overall study populations. Most scores at week 12 were 0 (none) or 1 (mild), with only one participant reporting scores of 2 (moderate) for itching, burning, and stinging. Conclusions: In the overall phase 3 clinical trials, fixed-dose, triple-combination CAB gel has demonstrated good efficacy, safety, and tolerability. All 5 cases presented here achieved substantial (>70%) acne lesion reductions, with 4/5 cases achieving treatment success or a 2-grade EGSS reduction by week 12. While patterns in cutaneous safety/tolerability were variable across cases, transient increases with CAB generally resolved to baseline values within two months of treatment. These clinical study cases reinforce the importance of patient education regarding efficacy and safety of acne treatment, including the importance of treatment adherence, managing patient expectations, and the potential for cutaneous effects, which are often transient. Support: Ortho Dermatologics

Guardian Knowledge in Primary Congenital Glaucoma: A Cross-Sectional Study

Précis: Guardian education level and frequency of surgical interventions are key determinants of knowledge in primary congenital glaucoma, highlighting the need for targeted educational strategies. Background: Management of congenital glaucoma poses unique challenges, particularly concerning the patient guardians’ understanding of the condition, which is crucial for treatment adherence and follow-up compliance. This study aimed to assess guardians’ knowledge levels and identify the influencing factors. Methods: This cross-sectional study included 103 guardians of pediatric patients with PCG. Participants with missing data were excluded from the study. The participants were assessed using a 20-question survey covering various aspects of glaucoma. Descriptive and inferential statistics were used for analysis. Results: The sample included 96 guardians, primarily females (80.2%). The children’s ages varied significantly, averaging approximately 44 months (SD = 39.8). The guardians predominantly had secondary education (34.4%) and most were housewives (77.1%). There was a positive correlation between higher education levels and the overall knowledge score of guardians (P = 0.006). Similarly, the guardian’s locality showed a positive correlation with knowledge scores, with urban guardians having higher scores than rural guardians. Additionally, there was a positive correlation between the number of surgical operations performed on the child and the guardians’ knowledge. For the subtotals, variables such as the child order among siblings and age of the child showed significant positive correlations, emphasizing the multifaceted influences on guardians’ understanding. In the multivariate analysis, the guardian’s education level showed a significant positive correlation for the Overall Score, as did the number of operations performed on the patient. Conclusions: The study revealed gaps in guardian knowledge, irrespective of educational level or other demographic factors. Guardians’ education level and the number of operations performed on the child are critical determinants of guardians’ understanding of congenital glaucoma. Traditional approaches to educational interventions may require re-evaluation, and there is a pressing need for targeted educational interventions.

Patient and Parent/Caregiver Satisfaction with Efficacy and Cosmetic Elegance of Tapinarof Cream 1% Once Daily in a Long-term Extension Trial in Adults and Children Down to Age 2 Years with Atopic Dermatitis

Introduction: Patients with atopic dermatitis (AD) report low satisfaction with currently available topical therapies. Satisfaction and patient preference are closely linked to treatment adherence, and understanding preferences may contribute to improving the quality of AD care and adherence. In the pivotal 8-week, phase 3 ADORING 1 and 2 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) once daily (QD) demonstrated superior efficacy versus vehicle and was well tolerated in adults and children down to age 2 years with AD. We report Patient Satisfaction Questionnaire© (PSQ) results from ADORING 3, a 48-week, open-label extension trial. Methods: In ADORING 3, eligible patients from ADORING 1 and 2, from a 4-week maximal usage pharmacokinetics trial, and tapinarof-naive patients with mild AD, or moderate or severe AD, that did not meet inclusion criteria for ADORING 1 or 2, were followed for up to 48 weeks. The PSQ was completed at Week 48 or at early termination visit and assessed patient or parent/caregiver satisfaction with tapinarof efficacy, cosmetic elegance (look and feel of tapinarof cream), application ease, impact on daily life, and preference for tapinarof versus prior AD therapies. Patients aged ≥16 years self-completed the PSQ; parents/caregivers completed for children aged 2 to 15 years. Results: 505 patients or parents/caregivers completed the questionnaire. Respondents consistently reported high rates of satisfaction across all parameters. Most patients or parents/caregivers strongly agreed or agreed with PSQ questions assessing satisfaction with cosmetic elegance (91.5%), quick absorption (89.5%), application ease (97.6%), impact on daily life (94.3%), efficacy (92.3%), and confidence in tapinarof (92.7%). For patients or parents/caregivers who reported prior use of other topical therapies to treat AD, most strongly agreed or agreed that tapinarof was more effective (86.3%), easier to use (68.6%), and that they preferred tapinarof to prior topicals (88.0%). Compared with systemic drugs used previously for AD, most strongly agreed or agreed that tapinarof was more effective (84.6%), easier to use (77.6%), and that they preferred tapinarof to prior systemic drugs (85.9%). Conclusion: Patient or parent/caregiver satisfaction data from ADORING 3 showed a consistent and highly positive perception of long-term use of tapinarof cream across all parameters, including satisfaction with tapinarof efficacy, cosmetic elegance, application ease, impact on daily life, and preference for tapinarof compared with prior AD therapies. Satisfaction with tapinarof is likely to contribute to long-term adherence and improved outcomes for patients with AD.

How feasible is nutrition intervention research in eating disorders? Lessons learnt from a pilot parallel randomised controlled trial of tyrosine supplementation in adolescents with anorexia nervosa.

Eating disorders are complex illnesses with high morbidity and mortality. Yet, there is promising evidence to support the effects of nutrition on the brain and behaviour. One proposed example is the use of tyrosine as an adjunct treatment in anorexia nervosa (AN). However, recruitment and retention in eating disorder clinical trials has posed difficulties for researchers. The aim of this study was to pilot test a parallel randomised controlled trial (RCT) of tyrosine supplementation to explore the feasibility of recruitment and retention, intervention adherence and data collection methods from the perspective of participants and researchers. Feasibility was assessed using numbers participating, questionnaire completion in patients and parent/carers completing and declining participation, a researcher implementation record and clinical measures. Subjects included adolescents aged 12-17 years with AN. The study was conducted over a 12-week period, with the intervention group receiving 5mg of L-tyrosine supplement and the control group receiving a placebo. Recruitment targets were not met and recruitment to a full RCT based on the current study protocol and recruitment sites did not prove feasible. Of the 39 approached for RCT participation, seven were recruited to the RCT (18% response rate) despite extending recruitment periods, with 100% retained and analysed. Patients or parents/carers identified barriers to study participation including burden, the need to consume tyrosine as tablets, and the use of blood, urine and psychological testing. Blood tyrosine rose markedly for subjects in the intervention group. No side effects were reported or measured. This study offers a unique exploration of the feasibility of a tyrosine trial in anorexia nervosa and is of relevance to assist the success of future nutrition trials. Exploring the suitability of future study designs for nutrition intervention research is warranted.

Impact of Multidisciplinary Team Management on Survival and Recurrence in Stage I–III Colorectal Cancer: A Population-Based Study in Northern Italy

This study aimed to assess whether multidisciplinary team (MDT) management improves outcomes in patients with stage I–III colorectal cancer (CRC) compared to non-MDT care. This study included 460 CRC patients diagnosed from 2017 to 2018 in a northern Italian province, of whom 300 (65%) were managed by MDT. MDT patients were younger, more frequently had rectal cancers, were diagnosed at earlier stages, and were more likely to undergo surgery and chemotherapy. Disease-free survival (DFS) and overall survival (OS) were significantly better in the MDT group. The recurrence rate was 8.5%, with no significant differences between MDT and non-MDT patients, although MDT patients exhibited lower recurrence rates for early-stage tumors. A multivariable analysis showed that DFS and OS were adversely affected by older age, advanced stage, and lack of MDT management. Kaplan–Meier estimates demonstrated a 3-year DFS of 78% in the MDT group versus 65% in the non-MDT group, as well as an OS of 83% versus 69%, respectively. The MDT approach was associated with improved treatment adherence and better management of recurrences. While limited by a small sample size, this population-based study highlights the beneficial impact of MDT care on CRC outcomes. Further research with extended follow-up is warranted to confirm these findings.

Nurse training to enhance adherence counselling for HIV-tuberculosis coinfection in South Africa: Integrative review

Background: South Africa has seen strides in reducing HIV and tuberculosis (TB); however, adherence counselling for people living with HIV (PLHIV) coinfected with TB remains a challenge, particularly in specific sub-districts like Cape Town. Understanding the attributes of existing training programmes is crucial.Objectives: This study explored attributes of training programme development for nurses and other health professionals to enhance adherence counselling for PLHIV coinfected with TB in Cape Town.Method: An integrative literature review was conducted in five steps following PRISMA guidelines. Electronic searches encompassed multiple databases: COCHRANE, PsycINFO, PUBMED, ENMBASE, Science Direct, SCOPUS, SocINDEX, Academic Search Complete, Eric, SABINET, Health Resources and World Health Organization Global Health Library Regional Indexes. Inclusion criteria encompassed English language, peer-reviewed full-text studies on training programme development, qualitative and quantitative, published between January 2012 and May 2021. Exclusion criteria included non-English articles, conference proceedings and irrelevant studies. Thematic data analysis synthesised findings.Results: Three main themes emerged: participant identification, key programme content and programme implementation process, crucial for effective training programme development.Conclusion: Identifying participants, defining programme content and outlining implementation processes are pivotal in enhancing nurses’ adherence counselling skills. This approach could stabilise patient treatment adherence, potentially reducing treatment default, loss to follow-up and mortality rates.Contribution: These findings lay the groundwork for developing effective training programmes aimed at improving adherence counselling among nurses.

Personalized interventions for behaviour change: A scoping review of just-in-time adaptive interventions.

Examine the development, implementation and evaluation of just-in-time adaptive interventions (JITAIs) in behaviour change and evaluate the quality of intervention reporting. A scoping review of JITAIs incorporating mobile health (mHealth) technologies to improve health-related behaviours in adults. We searched MEDLINE, Embase and PsycINFO using terms related to JITAIs, mHealth, behaviour change and intervention methodology. Narrative analysis assessed theoretical foundations, real-time data capturing and processing methods, outcome evaluation and summarized JITAI efficacy. Quality of intervention reporting was assessed using the template for intervention description and replication (TIDieR) checklist. Sixty-two JITAIs across physical activity, sedentary behaviour, dietary behaviour, substance use, sexual behaviour, fluid intake, treatment adherence, social skills, gambling behaviour and self-management skills were included. The majority (71%) aimed to evaluate feasibility, acceptability and/or usability. Supporting evidence for JITAI development was identified in 46 studies, with 67% applying this to develop tailored intervention content. Over half (55%) relied solely on self-reported data for tailoring, and 13 studies used only passive monitoring data. While data processing methods were commonly reported, 44% did not specify their techniques. 89% of JITAI designs achieved full marks on the TIDieR checklist and provided sufficient details on JITAI components. Overall, JITAIs proved to be feasible, acceptable and user-friendly across behaviours and settings. Randomized trials showed tailored interventions were efficacious, though outcomes varied by behaviour. JITAIs offer a promising approach to developing personalized interventions, with their potential effects continuously growing. The recommended checklist emphasizes the importance of reporting transparency in establishing robust intervention designs.

The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial.

The risk of breast cancer patients for long-term side effects of therapy such as neurotoxicity and cardiotoxicity as well as late effects regarding comorbidities varies from individual to individual. Personalised follow-up care concepts that are tailored to individual needs and the risk of recurrences, side effects and late effects are lacking in routine care in Germany. We describe the methodology of BETTER-CARE, a parallel-arm cluster-randomised controlled trial conducted at 15 intervention and 15 control centres, aiming to recruit 1140 patients, and the results of the pilot phase. The needs- and risk-adapted complex intervention, based on existing development frameworks, includes a multidisciplinary network and digital platforms for symptom and need documentation and just-in-time adaptive interventions. The control group comprises usual care according to clinical guidelines. The primary outcome is health-related quality of life (EORTC QLQ-C30 global health), and secondary outcomes include treatment adherence. The 2-month pilot phase comprising 16 patients in one intervention and one control pilot centre demonstrated the feasibility of the BETTER-CARE approach. BETTER-CARE is a feasible intervention and study concept, investigating individualised needs- and risk-adapted breast cancer follow-up care in Germany. If successful, the approach could be implemented in German routine care. German Clinical Trial Register DRKS00028840. Registered on April 2022.

Nomogram model for predicting medication adherence in patients with various mental disorders based on the Dryad database

ObjectiveTreatment compliance among psychiatric patients is related to disease outcomes. How to assess patient compliance remains a concern. Here, we established a predictive model for medication compliance in patients with...

A systematic review of efficacy and safety of newer drugs approved from 2016 to 2023 for the treatment of complicated urinary tract infections

Background: Complicated urinary tract infections are a significant cause of morbidity, hospitalization, and elevated hospital costs associated with kidney transplantations. The treatment of complicated urinary tract infections is very challenging, due to varying severities of infection and lower cure rates. The available drug options for treating these infections are limited, each with different mechanisms of action, efficacy, and safety profiles, making drug selection more difficult for healthcare professionals. Objectives: A systematic review was conducted to evaluate the safety and efficacy of drugs approved by the United States Food and Drug Administration for the treatment of complicated urinary tract infections between 2016 and 2023. The primary endpoint for all drugs used in treating complicated urinary tract infections was the cure rate. Results: Among the drugs used for treating complicated urinary tract infections, meropenem had the highest cure rate at 91.4%, followed by plazomicin at 88% and cefiderocol at 73% when used as monotherapy. In combination therapy, meropenem-vaborbactam had the highest cure rate at 98.4%, followed by piperacillin-tazobactam at 94%, and ceftazidime-avibactam at 87.5%. The safety profiles of the drugs indicated that almost all drugs caused gastrointestinal symptoms, with imipenem-relebactam and colistin-imipenem combinations having the most serious adverse events. Cefiderocol had a low magnitude of adverse events, with most side effects being mild gastrointestinal symptoms. Conclusion: The study concludes that appropriate drug selection and treatment adherence are crucial for preventing complicated urinary tract infections and improving health outcomes.

Abstract Su705: Predictive Model and Factors for Out-of-Hospital Cardiac Arrest in Geriatric Patients with insomnia: A Longitudinal Study

Background: Previous studies have shown that geriatric insomnia can impact the quality of life and lead to various health risks and comorbidities, which may further result in out-of-hospital cardiac arrest (OHCA). Therefore, assessing the risk of OHCA in elderly patients with insomnia is crucial. Hypothesis: We hypothesized that a predictive model incorporating demographic, clinical, and treatment adherence factors can effectively estimate the risk of OHCA among geriatric patients with insomnia. Aim: This study aimed to develop and validate a predictive model for OHCA in geriatric patients with insomnia using a large-scale population-based analysis. Method: A retrospective cohort study was conducted using data from Taiwan's Health and Welfare Data Science Center spanning from 2011 to 2020. The study included elderly patients diagnosed with insomnia who received medication. Predictors of OHCA, such as age, sex, comorbidities, medication adherence, and psychotherapy, were analyzed using multivariable logistic regression. Model performance was assessed using the area under the receiver operating characteristic curve (AUROC) with both internal and temporal validation. Results: Among 438,147 eligible elderly patients with insomnia, 7,666 experienced OHCA. Using data from 2011 to 2018 for model development, the AUROC for predicting OHCA within 7 days, 30 days, and 90 days ranged from 0.749 to 0.762 in the training set and 0.768 to 0.784 in the validation set. Key predictors included older age, male sex, prior medical resource use, hemodialysis, pre-existing comorbidities, medication possession ratio, medication changes, and recent psychotherapy (Figure 1). The model was also tested in 2019 and 2020 dataset (began of the COVID-19 in Taiwan), respectively, demonstrating consistent predictive performance (Figure 2). Specifically, the 7-day model in 2019 showed a sensitivity of 0.776, specificity of 0.632, and accuracy of 0.632, with a positive likelihood ratio (PLR) of 2.11, and negative likelihood ratio (NLR) of 0.36. In 2020, it achieved a sensitivity of 0.739, specificity of 0.661, accuracy of 0.661, PLR of 2.18, NLR of 0.40. Conclusion: The study developed a reliable predictive model for OHCA in geriatric patients with insomnia, highlighting significant predictors such as age, comorbidities, medication adherence, and recent psychotherapy. This model can aid clinicians in identifying high-risk patients and improving preventative care strategies.

CTNI-40. PSYCHOLOGICAL DOMAINS CORRELATE WITH ADHERENCE IN TTFIELDS TREATMENT OF GLIOBLASTOMA

Abstract INTRODUCTION Adherence is critical to the success of the treatment with Tumor Treating Fields (TTFields) for Glioblastoma Multiforme (GBM). Previously found factors influencing treatment adherence in general are social support, belief in the efficacy of treatment, communication with physicians, anxiety, and depression. We propose those five factors predict adherence to TTFields treatment since, to our knowledge, no systematic data exists for this treatment. METHODS We conducted a longitudinal study and included 25 patients with newly diagnosed GBM who received treatment with TTFields. Participants were invited to take part in six structured interviews, each four weeks apart, during their treatment with TTFields, assessing the five factors expected to influence treatment adherence over time. RESULTS We found a significant impact of communication, anxiety, and depression on treatment adherence with TTFields. Furthermore, also the time point during treatment (days of treatment) was significantly related to adherence. Better physician communication and a higher level of anxiety were associated with higher adherence and higher depression with less adherence. A higher belief in efficacy showed a trend toward significantly improving treatment adherence. When results were separately compared for early, middle, and later 90-day treatment phases, factors seemed to be differentially influential, with belief in efficacy being significantly relevant in the first, efficacy, communication, and anxiety in the second, and depression in the third phase of treatment with TTFields. CONCLUSIONS Our findings not only confirm the predictive role of psychosocial factors in treatment adherence but also provide specific targets for psychological interventions. This suggests that by addressing these factors, healthcare providers can potentially increase treatment adherence among GBM patients. Moreover, our results indicate that these interventions may be most effective when tailored to the specific phase of treatment, offering a practical approach for healthcare providers.

"Vulva," Not "Private Part": The Importance of Accurate Genital Terminology.

Effective communication in pediatric dermatology is critical for accurate diagnosis and treatment, particularly in sensitive areas such as the anogenital region. Unfortunately, children and their families often use euphemisms or incorrect terms when referring to this area, and many adults lack knowledge of anogenital terminology. Pediatric dermatologists can play a unique role in educating children and their families on correct anatomical language, which enhances body awareness, empowers young patients, improves safety, and contributes to accurate medical assessments and treatment adherence. By promoting the use of correct anatomical terms, pediatric dermatologists can improve patient outcomes and foster a healthier understanding of body anatomy and health.

DISP-09. IMPROVING ADHERENCE TO CANCER CARE IN UNDERSERVED PATIENTS WITH CENTRAL NERVOUS SYSTEM TUMORS

Abstract Patients with central nervous system tumors have disease-specific symptoms such as aphasias, motor symptoms, neuropsychiatric symptoms, or seizures that make treatment adherence difficult. This is further exacerbated by the social determinants of health – patients from historically marginalized groups or those with lower socioeconomic status have additional barriers to treatment. The Integrated Cancer Care Access Network (ICCAN) is a multi-institutional patient navigation program assisting patients who express socioeconomic needs during cancer treatment. In this pilot program, we assessed the impact of ICCAN on treatment adherence and quality of life of CNS cancer patients from marginalized backgrounds. 42 participants with primary brain tumors or brain metastases were recruited from inpatient and outpatient services at Memorial Sloan Kettering Cancer Center to enroll in ICCAN-CNS. Patients were eligible if they were 18 years or older, receiving active treatment or under active surveillance, and screened positive for an essential need. Through standardized patient interviews and questionnaires, we evaluated their needs such as food access, housing, and financial needs. The clinical research coordinator interviewed the patients via phone, taking approximately 60 minutes. The interviews comprised an Essential Needs Assessment, Health Related Social Needs Assessment, NCCN Distress Thermometer, and an ICCAN-CNS questionnaire focused on neurology-specific symptoms. Caregivers helped complete the questions for patients with cognitive impairments. Patients were then matched with resources based on their initial needs assessment. The interviewer conducted 2, 4, and 6-month follow-ups to see if new needs emerged for which resources were provided. Response to the program was overwhelmingly positive with many patients expressing gratitude for the resources provided to them. This pilot demonstrates the feasibility of CNS tumor patients participating in the ICCAN intervention and the need for additional patient navigation programs and interventions that focus on the social determinants of health.

TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.

Treatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies. TEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs). Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain. These outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS. ClinicalTrials.gov identifier, NCT04221191.

CTNI-20. ADDRESSING SKIN ADVERSE EVENTS (AES) DURING MIRDAMETINIB TREATMENT IN PATIENTS WITH NEUROFIBROMATOSIS TYPE 1-ASSOCIATED PLEXIFORM NEUROFIBROMAS (NF1-PN): GUIDANCE FROM A MULTIDISCIPLINARY GROUP OF EXPERTS ON THE MANAGEMENT OF MEK INHIBITOR-ASSOCIATED SKIN AES

Abstract ReNeu (NCT03962543) is a trial of the investigational, oral, selective MEK1/2 inhibitor (MEKi) mirdametinib in adults (≥18 years) and children (2-17 years) with NF1-PN. Skin adverse events (AEs) were common in ReNeu, and some discontinuations were noted with low-grade AEs. A multidisciplinary team retrospectively reviewed skincare practices at one high-enrolling site (n=12) with no discontinuations due to skin AEs; these were incorporated into ReNeu trial recommendations and recently updated. The purpose was to prevent/manage skin AEs and maintain protocol treatment adherence. MEKi skin AEs vary by pubertal status, therefore recommendations also vary by pubertal status. All patients were counseled to adopt hygienic skincare practices, including bathing daily, and using mild cleansers and hypoallergenic skin moisturizers (cream or ointment-based emollient; minimum BID) to prevent dry skin. Prepubescent patients were advised to incorporate diluted bleach baths (3-4 times/week) when initiating mirdametinib or after rash development. Treatments recommended for mild-to-severe dermatitis were hydrocortisone cream (2.5% BID) on face/skinfold areas and triamcinolone ointment (0.1% BID) on trunk/extremities. Treatments for mild acneiform eruptions included topical clindamycin lotion (1.0% BID) until resolution, with optional hydrocortisone cream (2.5% BID). For moderate-to-severe acneiform eruptions, cephalexin (20 mg/kg/day divided BID, max 500 mg, ≤6 weeks), amoxicillin (25 mg/kg/day divided BID, max 875 mg, ≤6 weeks), or oral fluconazole (20 mg/kg/day, max 100 mg, 5 days then once weekly for 3 months) were suggested. Postpubescent patients were advised to initiate topical 1.0% clindamycin lotion and oral doxycycline or minocycline (50-mg daily, 3 months) with mirdametinib initiation. Patients with subsequent mild-to-severe acneiform eruptions were advised to apply hydrocortisone cream (2.5% BID) or triamcinolone ointment (0.1% BID). Referral to a dermatologist was suggested for all patients with uncontrolled dermatitis, worsening acneiform eruptions, or infection. Proactive skincare practices appeared effective at this site, but prospective validation is necessary before making clinical recommendations.