Overall burden and impact on health-related quality of life associated with intravesical treatment of patients with non-muscle invasive bladder cancer in the United States.

BACKGROUND: This study aimed to describe the life impacts of intravesical therapies for non-muscle invasive bladder cancer (NMIBC) from a patient perspective. METHODS: A cross-sectional online survey design was used. Adults with NMIBC (and no other cancer) treated intravesically in the prior 12 months were recruited from US patient online communities. Individuals participating in a clinical trial or treated with erdafitinib were excluded. Participants' treatment experiences were evaluated using a questionnaire comprising (a) custom questions reported on 11-point numerical rating scales and (b) validated patient reported outcome (PRO) measures for bladder symptom burden and work productivity. RESULTS: Among 171 survey participants, most received bacillus Calmette-Guérin (BCG) (83%), intravesical gemcitabine (28%), or gemcitabine + docetaxel (13%) during the past year. Participants generally felt adequately informed about treatment, felt expectation of treatment matched actual experience, and expressed intent to complete the full treatment course and willingness to try different treatments if needed. Participants reported disease symptom burden of 42.6/72 on the NFBlSI-18 scale. Employed participants reported 51% work impairment and 59% overall work productivity loss due to NMIBC. CONCLUSIONS: Participants recently treated with intravesical therapies expressed intent to complete the full treatment course and willingness to try new therapies if needed. Participants reported high NMIBC symptom burden and work impairment negatively impacting their well-being, despite receiving intravesical treatment.

Treatment burden in multimorbidity: an integrative review.

BACKGROUND: People living with multimorbidity experience increased treatment burden, which can result in poor health outcomes. Despite previous efforts to grasp the concept of treatment burden, the treatment burden of people living with multimorbidity has not been thoroughly explored, which may limit our understanding of treatment burden in this population. This study aimed to identify the components, contributing factors, and health outcomes of treatment burden in people with multiple diseases to develop an integrated map of treatment burden experienced by people living with multimorbidity. The second aim of this study is to identify the treatment burden instruments used to evaluate people living with multimorbidity and assess the comprehensiveness of the instruments. METHODS: This integrative review was conducted using the electronic databases MEDLINE, EMBASE, CINAHL, and reference lists of articles through May 2023. All empirical studies published in English were included if they explored treatment burden among adult people living with multimorbidity. Data extraction using a predetermined template was performed. RESULTS: Thirty studies were included in this review. Treatment burden consisted of four healthcare tasks and the social, emotional, and financial impacts that these tasks imposed on people living with multimorbidity. The context of multimorbidity, individual's circumstances, and how available internal and external resources affected treatment burden. We explored that an increase in treatment burden resulted in non-adherence to treatment, disease progression, poor health status and quality of life, and caregiver burden. Three instruments were used to measure treatment burden in living with multimorbidity. The levels of comprehensiveness of the instruments regarding healthcare tasks and impacts varied. However, none of the items addressed the healthcare task of ongoing prioritization of the tasks. CONCLUSIONS: We developed an integrated map illustrating the relationships between treatment burden, the context of multimorbidity, people's resources, and the health outcomes. None of the existing measures included an item asking about the ongoing process of setting priorities among the various healthcare tasks, which highlights the need for improved measures. Our findings provide a deeper understanding of treatment burden in multimorbidity, but more research for refinement is needed. Future studies are also needed to develop strategies to comprehensively capture both the healthcare tasks and impacts for people living with multimorbidity and to decrease treatment burden using a holistic approach to improve relevant outcomes. TRIAL REGISTRATION: DOI: https://doi.org/10.17605/OSF.IO/UF46V.

The digital cumulative complexity model: a framework for improving engagement in digital mental health interventions.

Mental health disorders affect a substantial portion of the global population. Despite preferences for psychotherapy, access remains limited due to various barriers. Digital mental health interventions (DMHIs) have emerged to increase accessibility, yet engagement and treatment completion rates are concerning. Evidence across healthcare where some degree of self-management is required show that treatment engagement is negatively influenced by contextual complexity. This article examines the non-random factors influencing patient engagement in digital and face-to-face psychological therapies. It reviews established models and introduces an adapted version of the Cumulative Complexity Model (CuCoM) as a framework for understanding engagement in the context of digital mental health. Theoretical models like the Fogg Behavior Model, Persuasive System Design, Self-Determination Theory, and Supportive Accountability aim to explain disengagement. However, none adequately consider these broader contextual factors and their complex interactions with personal characteristics, intervention requirements and technology features. We expand on these models by proposing an application of CuCoM's application in mental health and digital contexts (known as DiCuCoM), focusing on the interplay between patient burden, personal capacity, and treatment demands. Standardized DMHIs often fail to consider individual variations in burden and capacity, leading to engagement variation. DiCuCoM highlights the need for balancing patient workload with capacity to improve engagement. Factors such as life demands, burden of treatment, and personal capacity are examined for their influence on treatment adherence. The article proposes a person-centered approach to treatment, informed by models like CuCoM and Minimally Disruptive Medicine, emphasizing the need for mental healthcare systems to acknowledge and address the unique burdens and capacities of individuals. Strategies for enhancing engagement include assessing personal capacity, reducing treatment burden, and utilizing technology to predict and respond to disengagement. New interventions informed by such models could lead to better engagement and ultimately better outcomes.

Prevalence of and Factors Associated with Treatment Burden and Medication Adherence Among Primary Care Patients with Multimorbidity in Jeddah, Saudi Arabia: A Cross-Sectional Study.

BACKGROUND: Multimorbidity, the coexistence of multiple chronic conditions, presents significant challenges in treatment management and medication adherence. This study investigates the burden of multimorbidity and factors influencing treatment adherence among primary care patients in Jeddah, Saudi Arabia. METHODS: A cross-sectional study was conducted from November to December 2023, including 422 participants selected via stratified random sampling from 12 primary healthcare centers in Jeddah. Participants were adults aged 18 years or older with two or more confirmed long-term medical conditions. The Multimorbidity Treatment Burden Questionnaire (MTBQ) and General Medication Adherence Scale (GMAS) were used to measure treatment burden and medication adherence, respectively. Demographic variables were assessed for their influence on these outcomes. RESULTS: High treatment burden was reported by 55% of participants, while 21% reported medium burden, 15% experienced low burden and 9% no burden. Medication adherence was partial in 69% of participants, with 13% reporting high adherence, 13% good adherence, and 5% poor adherence. Statistically significant differences in MTBQ scores were observed based on marital status, education level, residence, occupation, and income. GMAS scores varied statistically significantly with marital status, education level, residence, occupation, income, and previous self-care education session attendance and MTBQ scores, with those having high burden reporting the lowest adherence scores. CONCLUSIONS: Demographic factors, including marital status, education level, residence, occupation, and income, significantly influence multimorbidity treatment burden and medication adherence. A higher treatment burden was associated with lower adherence. Targeted interventions addressing these factors could improve treatment outcomes for patients with multiple chronic conditions.

Oral health, treatment burden and demographics of elders with care-resistant behavior: A cross-sectional study.

AIMS: To assess oral health, treatment burden, mortality risk, and demographics in elders with care-resistant behaviors (CRB) in nursing homes (NH) and compare them with those without CRB. METHODS AND RESULTS: 503 participants from eight NH who received dental treatment through a mobile dental clinic were included. Their medical and dental records were screened regarding oral/dental health, treatment history, general health, demographics, and CRB. Statistical analysis was performed to show correlations between CRB and the measured parameters. Data were verified for normal distribution; a point-biserial correlation model was used (95% CI: α = 0.05). No correlation was found between CRB and Decayed Missing Filled Teeth (DMF-T) (rpb = -0.061, p = .177), as well as periodontal status (rpb = 0.004, p = .946). A negative correlation was observed between CRB and the required number of treatment procedures (rpb = -0.181, p < .0001), time (rpb = -0.118, p = .010), and costs (rpb = -0.100, p = .028). Sex predilection for men regarding CRB was evident (rpb = -0.155, p = .01). No correlation appeared between CRB and vital status (rpb = -0.41, p = .355). CONCLUSION: Oral health seems to be similar in institutionalized elders with or without CRB. Treatment burden was not elevated, but even reduced in elders with CRB, evincing that few/no treatment procedures were performed in those elders. CRB demonstrated a sex predilection for men. An association between CRB and increased mortality was not evident.

Patient and Physician Perspectives of Treatment Burden in Multiple Sclerosis.

The number of disease-modifying therapies (DMTs) approved for the treatment of multiple sclerosis (MS) has greatly increased in recent decades, leading to higher treatment complexity. DMTs can differ in mode and frequency of administration, benefit-risk profile, and associated costs. Patients with MS contend not only with the burden of their chronic disease but also with the treatment burden of their MS therapy. Adhering to dosing schedules and infusion appointments can be difficult for busy, working-age patients or those with limited access to transportation. Patients and healthcare professionals (HCPs) may have differing priorities, concerns, and preferences when selecting treatment, potentially affecting treatment satisfaction and, importantly, adherence. Additionally, patients face direct and indirect costs related to treatment. These factors can all contribute to a high treatment burden on patients, impacting their quality of life and potentially leading to worse patient outcomes. HCPs, patients, and caregivers must work together to alleviate treatment burden through effective communication, shared decision-making, appreciating each other's perspectives, and additional HCP support. Consideration of treatment burden into clinical guidelines is also warranted. In this review, we examine key factors impacting treatment burden for patients with MS, with a focus on the patient perspective as provided by our patient authors, and provide strategies to minimize treatment burden.

Trajectories of Treatment Burden Among Primary Care Patients with Long-Term Conditions in Southern China: A Latent Class Growth Analysis.

Background: Treatment burden is a patient-centred, dynamic concept. However, longitudinal data on the changing pattern of treatment burden among patients with one or more long-term conditions (LTCs) are relatively scanty. We aimed to explore the longitudinal trajectories of treatment burden and associated risk factors in a large, patient population in primary care settings. Methods: We analysed data from 5573 primary care patients with long-term conditions (LTCs) recruited using a multistage sampling method in Shenzhen, southern China. The treatment burden was assessed by the Mandarin Chinese version of the Treatment Burden Questionnaire (TBQ). We used latent class growth mixture modelling (LCGMM) to determine trajectories of treatment burden across four time points, ie, at baseline, and at 6, 12, and 18 months. Predictors of trajectory classes were explored using multivariable logistic regression analysis. Results: The mean TBQ scores of patients with a single LTC (n = 2756), 2 LTCs (n = 1871), 3 LTCs (n = 699), and ≥4 LTCs (n = 247) were 18.17, 20.28, 21.32, and 26.10, respectively, at baseline. LCGMM identified three discrete classes of treatment burden trajectories over time, ie, a high-increasing class, a low-stable class, and a high-decreasing class. When controlling for individual-level factors including age, education, monthly household income per head, smoking, alcohol consumption, and attendance in health education, patients who had a clinical diagnosis of 3 LTCs (adjusted odds ratio [aOR] = 1.49, 95% CI = 1.21-1.86, P < 0.001) or ≥4 LTCs (aOR = 1.97, 95% CI = 1.44-2.72, P < 0.001) were more likely to belong to the high-increasing class. Sensitivity analysis using propensity score methods obtained similar results. Conclusion: Our study revealed the presence of discrete patterns of treatment burden over time in Chinese primary care patients with LTCs, providing directions for tailored interventions to optimise disease management. Patients with 3 or more LTCs should receive close attention in healthcare delivery as they tend to experience a greater treatment burden.

Approved treatments for neovascular age-related macular degeneration: current safety and future directions.

INTRODUCTION: Age-related macular degeneration (AMD) is a progressive retinal degenerative disease that is implicated as one of the leading causes of visual impairment in the elderly population. Vascular endothelial growth factor (VEGF) has been identified as the main driver of AMD, and various therapeutics have revolutionized the treatment and management of neovascular AMD (nAMD) with favorable visual and anatomical outcomes. AREAS COVERED: Physicians have a variety of approved therapeutics in their arsenal for patients with varying disease progression and patient-specific needs, with the ultimate goal of achieving optimal visual and anatomic outcomes. The literature search was conducted using PubMed, Google Scholar, and sources from companies' websites, allowing us to locate findings recently presented at conferences. EXPERT OPINION: Scientific advancements in the field have led to newly approved therapeutics and devices, such as the port-delivery system with ranibizumab (PDS), and further investigation is ongoing in the realm of gene therapy for retinal diseases. In addition to efficacy and durability, newer agents must have comparable safety profiles to older agents in order to be used broadly. These options introduce a level of complexity in nAMD treatment; however, physicians to personalize treatment to improve vision in nAMD patients and reduce treatment burden overall.

The Chinese version of patient experience with treatment and self-management (PETS vs. 2.0): translation and validation in patients with multimorbidity in primary care in Hong Kong.

BACKGROUND: Validated and comprehensive tools to measure treatment burden are needed for healthcare professionals to understand the treatment burden of patients in China. The study aimed to translate and validate the Chinese version of Patient Experience with Treatment and Self-management (PETS vs. 2.0) in patients with multimorbidity in primary care. METHODOLOGY: The translation process of the 60-item PETS vs. 2.0 followed the Functional Assessment of Chronic Illness Therapy (FACIT) Translation, Formatting, and Testing Guidelines. Computer-assisted assessments were conducted in adult primary care patients with multimorbidity from three general out-patient clinics in Hong Kong. A sample of 502 patients completed the assessments from July to December 2023. Internal reliability was examined using Cronbach's alphas for each domain of the PETS vs. 2.0. Concurrent validity was assessed through the correlations between different domains of PETS vs. 2.0 with established measures including quality of life, frailty, and depression. Confirmatory Factor Analysis (CFA) with maximum likelihood method was carried out to assess the construct validity. RESULTS: The mean age of participants was 64.9 years old and 56.2% were female. Internal consistency reliability was acceptable (alpha ≥ 0.70) for most domains. Higher scores of PETS domains were significantly correlated with worse quality of life, higher level of frailty, and more depressive symptoms (p < 0.05). In CFA, after setting the covariances on the error variances, the adjusted model revealed an acceptable model fit (χ2/df = 1.741; root mean square error of approximation (RMSEA) = 0.038; standardized root mean square residual (SRMR) = 0.058; comparative fit index (CFI) = 0.911; Tucker-Lewis Index (TLI) = 0.903). All standardized factor loadings were 0.30 or above. Significant positive correlations between the latent factors were found for all factor pairs (correlation coefficient < 0.8). CONCLUSIONS: The Chinese version of PETS vs. 2.0 is a reliable and valid tool for assessing the perceived treatment burden in patients with multimorbidity in primary care. All domains and items in the original questionnaires were retained.

Reduced Volume and Faster Infusion Rate of Activated Prothrombin Complex Concentrate: A Phase 3b/4 Trial in Adults with Hemophilia A with Inhibitors.

Background Activated prothrombin complex concentrate (aPCC) is indicated for bleed treatment and prevention in patients with hemophilia with inhibitors. The safety and tolerability of intravenous aPCC at a reduced volume and faster infusion rates were evaluated. Methods This multicenter, open-label trial (NCT02764489) enrolled adults with hemophilia A with inhibitors. In part 1, patients were randomized to receive three infusions of aPCC (85 ± 15 U/kg) at 2 U/kg/min (the approved standard rate at the time of the study), in a regular or 50% reduced volume, and were then crossed over to receive three infusions in the alternative volume. In part 2, patients received three sequential infusions of aPCC in a 50% reduced volume at 4 U/kg/min and then at 10 U/kg/min. Primary outcome measures included the incidence of adverse events (AEs), allergic-type hypersensitivity reactions (AHRs), infusion-site reactions (ISRs), and thromboembolic events. Results Of the 45 patients enrolled, 33 received aPCC in part 1 and 30 in part 2. In part 1, 24.2 and 23.3% of patients with regular and reduced volumes experienced AEs, respectively; 11 AEs in eight patients were treatment related. AHRs and ISRs occurred in four (12.1%) and two (6.1%) patients, respectively. In part 2, 3.3 and 14.3% of patients with infusion rates of 4 and 10 U/kg/min experienced AEs, respectively; only one AE in one patient was treatment related; no AHRs or ISRs were reported. Most AEs were mild/moderate in severity. Overall, no thromboembolic events were reported. Conclusions aPCC was well tolerated at a reduced volume and faster infusion rates, with safety profiles comparable to the approved regimen.

Assessment of patient-reported treatment burden in patients with coronary artery disease.

Introduction: Patient-reported treatment burden (TBN) refers to the patient's time and effort invested in the management of their chronic health conditions. The aim of this research was to explore TBN in patients with coronary artery disease (CAD). Methods: Consecutive patients with chronic medical condition(s) were invited to complete the study questionnaires (TBN and EQ-5D). Results: Of 514 enrolled patients, 116 (22.6%) patients had CAD. The mean TBN score for CAD vs. non-CAD was 40.49 ±21.54 and 46.17 ±21.44 (p = 0.023), respectively. Conclusions: Patients with CAD could have a lower TBN in comparison to patients with other chronic medical conditions.

Measuring treatment burden in people with Type 2 Diabetes Mellitus (T2DM): a mixed-methods systematic review.

BACKGROUND: Measuring treatment burden is important for the effective management of Type 2 Diabetes Mellitus (T2DM) care. The purpose of this systematic review was to identify the most robust approach for measuring treatment burden in people with T2DM based on existing evidence. METHODS: Articles from seven databases were retrieved. Qualitative, quantitative, and mixed-methods studies examining treatment burden in adults with T2DM and/or reporting relevant experiences were included. A convergent segregated approach with a mixed-methods design of systematic review was employed, creating a measurement framework in a narrative review for consistent critical appraisal. The quality of included studies was assessed using the Joanna Briggs Institute tool. The measurement properties of the instruments were evaluated using the Consensus based Standards for selection of Health Measurement Instruments (COSMIN) checklist. RESULTS: A total of 21,584 records were screened, and 26 articles were included, comprising 11 quantitative, 11 qualitative, and 4 mixed-methods studies. A thematic analysis of qualitative data extracted from the included articles summarised a measurement framework encompassing seven core and six associated measurements. The core measurements, including financial, medication, administrative, lifestyle, healthcare, time/travel, and medical information burdens, directly reflect the constructs pertinent to the treatment burden of T2DM. In contrast, the associated measurement themes do not directly reflect the burdens or are less substantiated by current evidence. The results of the COSMIN checklist evaluation demonstrated that the Patient Experience with Treatment and Self-management (PETS), Treatment Burden Questionnaire (TBQ), and Multimorbidity Treatment Burden Questionnaire (MTBQ) have robust instrument development processes. These three instruments, with the highest total counts combining the number of themes covered and "positive" ratings in COSMIN evaluation, were in the top tertile stratification, demonstrating superior applicability for measuring T2DM treatment burden. CONCLUSIONS: This systematic review provides evidence for the currently superior option of measuring treatment burden in people with T2DM. It also revealed that most current research was conducted in well-resourced institutions, potentially overlooking variability in under-resourced settings.

'The burden is very much on yourself': A qualitative study to understand the illness and treatment burden of hearing loss across the life course.

INTRODUCTION: Hearing loss is a chronic health condition that rises sharply with age. The way people respond to and cope with health conditions is influenced by their capacity to perform illness and treatment-related work. The aim was to explore the cumulative burdens of living with hearing loss and the resources mobilised to ease the burdens. METHODS: A qualitative design was used with semi-structured interviews (online or in-person) with participants recruited through audiology services and nonclinical services, such as lip-reading classes. Forty-six participants with hearing loss aged between 16 and 96 years were interviewed. An abductive approach, informed by May et al.'s burden of treatment theory, was used to analyse the data. RESULTS: The illness burden involved participants working to make sense of their hearing loss, engaging in emotional work in response to changes in sound, social interactions and identity and coping with the daily frustrations required to communicate with others. Abandonment and uncertainty characterised the treatment burden; participants engaged in emotional work to adjust to hearing technology and deal with the uncertainty of how their hearing might progress. To ameliorate the burdens, participants drew on internal resources (psychological, health literacy, cognitive) and external resources (social support, financial, information, technology). CONCLUSIONS: The workload of hearing loss appears largely devolved to the patient and is not always visible. Our work indicates the need to widen approaches in audiological care through the implementation of lifeworld-led care, family-centred care and peer support to build support for those with hearing loss. PATIENT OR PUBLIC CONTRIBUTION: We developed the project in consultation with members of the public who have lived experience of hearing loss recruited through Aston University and volunteer links to audiology services. We also consulted people more likely to be affected by hearing loss adults including adults with learning disabilities, older adults in residential care and people from South Asia (Bangladeshi, Indian and Pakistani communities). These individuals commented on the study aims, interview schedule and participant recruitment practices. One of our co-authors (expert by experience) contributed to the development and interpretation of themes and preparation of the final manuscript.

Patient Experience Survey of Anti-Vascular Endothelial Growth Factor Treatment for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

INTRODUCTION: Understanding patient perspectives of treatment may improve adherence and outcomes. This study explored real-world patient experiences with anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). METHODS: This multinational, non-interventional, quantitative, cross-sectional, observational survey assessed treatment barriers/burden, patient-reported visual functioning, and treatment satisfaction in DME and nAMD patients in the USA, the UK, Canada, France, Italy, and Spain. Treatment patterns and visual outcomes were extracted from medical charts. Regression models evaluated relationships between adherence, total missed visits, number of anti-VEGF injections, and clinical and patient-reported outcomes for visual functioning. Association between treatment satisfaction and aspects of burden were assessed. RESULTS: The survey was completed by 183 DME and 391 nAMD patients. Patients had moderately high vision-related functioning (25-item National Eye Institute Visual Functioning Questionnaire score: mean = 74.8) and were satisfied with their current treatment (mean total score: Macular Disease Treatment Satisfaction Questionnaire = 59.2; Retinopathy Treatment Satisfaction Questionnaire = 61.3). Treatment satisfaction scores were worse with higher time-related impacts of treatment (nAMD/DME), higher impacts on finances and daily life (nAMD), negative impacts on employment and lower expectations for treatment effectiveness (DME). Most patients reported ≥1 barrier (66.1% DME, 49.2% nAMD patients) related to treatment (35.0%), clinic (32.6%), and COVID-19 (21.1%). Moreover, 44.9% of patients reported some impairment in activities of daily living. Work absenteeism was observed among >60% of working patients. Nearly one-quarter (24.2%) of patients needed ≥1 day to recover from intravitreal injections; most reported ≥30 min of travel time (73.7%) and clinic wait time (54.2%). In unadjusted univariable analyses, treatment adherence (vs. nonadherence) was related to higher most recent visual acuity (ß = 8.98 letters; CI, 1.34-16.62) and lower odds of visual acuity below driving vision (≤69 letters) (OR = 0.50; CI, 0.25-1.00). CONCLUSION: More durable treatments with reduced frequency of injections/visits may reduce treatment burden and improve patient satisfaction, which may enhance adherence and visual outcomes.

Impact of Digital Interventions on the Treatment Burden of Patients With Chronic Conditions: Protocol for a Systematic Review.

BACKGROUND: There is great potential for delivering cost-effective, quality health care for patients with chronic conditions through digital interventions. Managing chronic conditions often includes a substantial workload required for adhering to the treatment regimen and negative consequences on the patient's function and well-being. This treatment burden affects adherence to treatment and disease outcomes. Digital interventions can potentially exacerbate the burden but also alleviate it. OBJECTIVE: The objective of this review is to identify, summarize, and synthesize the evidence of how digital interventions impact the treatment burden of people with chronic conditions. METHODS: The search, selection, and data synthesis processes were designed according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015. A systematic search was conducted on October 16, 2023, from databases PubMed, Scopus, Web of Science, ACM, PubMed Central, and CINAHL. RESULTS: Preliminary searches have been conducted, and screening has been started. The review is expected to be completed in October 2024. CONCLUSIONS: As the number of patients with chronic conditions is increasing, it is essential to design new digital interventions for managing chronic conditions in a way that supports patients with their treatment burden. To the best of our knowledge, the proposed systematic review will be the first review that investigates the impact of digital interventions on the treatment burden of patients. The results of this review will contribute to the field of health informatics regarding knowledge of the treatment burden associated with digital interventions and practical implications for developing better digital health care for patients with chronic conditions. TRIAL REGISTRATION: PROSPERO CRD42023477605; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=477605. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54833.

Exploring treatment burden in people with type 2 diabetes mellitus: a thematic analysis in china's primary care settings.

BACKGROUND: Understanding treatment burden is a critical element to the effective management of Type 2 Diabetes Mellitus (T2DM). The current study aims to address the knowledge gap surrounding treatment burden of T2DM from the patient's perspective in China's primary care settings. METHODS: A narrative review informed the creation of an a priori coding structure to identify aspects of T2DM treatment burden. Focus groups were conducted, employing a maximum variation sampling strategy to select participants from diverse sociodemographic backgrounds across urban, suburban, rural, and remote areas in China. Participants included adults with T2DM care in primary care settings for over a year and a Treatment Burden Questionnaire score of 25 or higher. Deductive thematic analysis, guided by the coding structure, facilitated a comprehensive exploration and further development of the conceptual framework of T2DM treatment burden. RESULTS: Four focus groups, each comprising five participants from diverse areas, were conducted. Utilising the Cumulative Complexity Model and Normalisation Process Theory as theoretical underpinnings, the thematic analysis refined the conceptual framework based on the coding structure from the narrative review. Five key themes were refined, encompassing medical information, medication, administration, healthcare system, and lifestyle. Additionally, the financial and time/travel themes merged into a new theme termed "personal resources", illustrating their overlapping within the framework. Participants in these focus groups highlighted challenges in managing medical information, an aspect often underrepresented in prior treatment burden research. The thematic analysis culminated in a finalised conceptual framework, offering a comprehensive understanding of the treatment burden experiences of people with T2DM in China's primary care settings. This framework includes six key constructs, delineating T2DM treatment burden and associated factors, such as antecedents and consequences. CONCLUSIONS: This study provides insights into the treatment burden of T2DM. A conceptual framework was finalised to deepen the understanding of the multifaceted constructs and the nature of treatment burden in people with T2DM. Furthermore, it emphasises the need to tailor T2DM treatment to individual capacities, considering their personal resource allocation and treatment utilisation.

Real-world experience of using stereotactic radiotherapy combined with anti-vascular endothelial growth factor to treat neovascular AMD.

INTRODUCTION: Adjunctive treatment or longer-acting drugs are required to treat nAMD to help ease burdens for patients and hospital clinics alike. Stereotactic therapy is one such option, providing a reduction in the number of injections over time. OBJECTIVE: To determine the clinical outcomes in a cohort of patients with nAMD receiving a combination therapy of stereotactic radiotherapy (SRT) with intravitreal anti-VEGF injections (IVI). METHOD: A retrospective analysis of 74 patients with nAMD, who had received IVI and SRT (16 Gray maximum dose to the macula) at a large tertiary university eye hospital, between March 2018 and September 2019 was performed. The number of IVIs, visual acuity (VA), and central retinal thickness (CRT) were evaluated at 12, 24, and 36 months after patients received SRT and compared to the same time interval prior to SRT. RESULTS: Follow-up data at 12, 24, and 36 months following and prior to SRT was available for 74, 48, and 22 patients respectively. Overall there was a significant reduction in the number of injections post-SRT. Twelve months following SRT, the median number of IVI was reduced by 1 (p < 0.05). The reduction in the median number of IVI was significantly reduced by 3 and 6 injections at 24- and 36-month follow-up respectively (p < 0.05). The CRT was significantly reduced post-SRT compared to the baseline values at all time periods. There was no statistically significant difference in VA at 12-month follow-up compared to baseline. The VA, however, significantly decreased at 24- and 36-month follow-up (p < 0.05). CONCLUSION: A therapy combining SRT with IVI has shown an overall reduction in the number of injections required in nAMD patients at 12, 24, and 36 months following SRT compared to IVI treatment alone. These real-world outcomes are comparable to other studies while also confirming the maintenance of the reduced frequency of required IVI for patients with nAMD.

Above and Beyond Number of Illnesses: A Two-Sample Replication of Current Approaches to Depressive Symptoms in Multimorbidity.

OBJECTIVES: To expand current models of depressive symptoms in older adults with multimorbidity (MM) beyond the number of illnesses as a predictor of worsened mental health. METHODS: Two-sample replication study of adults ≥62 years old with ≥ two chronic illnesses, who completed validated questionnaires assessing depressive symptoms, and disease- and treatment-related stressors. Data were analyzed using hierarchical linear regression. RESULTS: The model of cumulative number of illnesses was worse at explaining variance in depressive symptoms (Sample 1 R2 = .035; Sample 2 R2 = .029), compared to models including disease- and treatment-related stressors (Sample 1 R2 = .37; Sample 2 R2 = .47). Disease-related stressors were the strongest factor associated with depressive symptoms, specifically, poor subjective cognitive function (Sample 1: b = -.202, p = .013; Sample 2: b = -.288, p < .001) and greater somatic symptoms (b = .455, p < .001; Sample 2: b = .355, p < .001). CONCLUSIONS: Using the number of illnesses to understand depressive symptoms in MM is a limited approach. Models that move beyond descriptive relationships between MM and depressive symptoms are needed. CLINICAL IMPLICATIONS: Providers should consider the role of somatic symptom management in patients with MM and depressive symptoms.

Social Disconnectedness in Individuals with Cardiovascular Disease: Associations with Health Literacy and Treatment Burden.

BACKGROUND: Knowledge is limited on associations between social disconnectedness (i.e. loneliness and social isolation), health literacy and perceived treatment burden in individuals with cardiovascular disease (CVD). However, understanding these associations may be important for clinical practice. METHODS: This study used cross-sectional self-reported data from the 2017 Danish health and morbidity survey entitled 'How are you?', investigating the associations of loneliness and social isolation with low health literacy and high treatment burden in individuals with CVD (n = 2521; mean age = 65.7 years). RESULTS: Logistic regression analysis showed that loneliness and social isolation were associated with low health literacy in terms of difficulties in 'understanding health information' (loneliness: adjusted odds ratio (AOR) = 1.32, 95% confidence intervals (CI) [1.16, 1.50]; social isolation: AOR = 1.47, 95% CI [1.24, 1.73]) and 'engaging with healthcare providers' (loneliness: AOR = 1.53, 95% CI [1.37, 1.70]; social isolation: AOR = 1.21, 95% CI [1.06, 1.40]) and associated with high treatment burden (loneliness: AOR = 1.49, 95% CI [1.35, 1.65]; social isolation: AOR = 1.20, 95% CI [1.06, 1.37]). CONCLUSIONS: Our findings show that loneliness and social isolation coexisted with low health literacy and high treatment burden in individuals with CVD. These findings are critical as socially disconnected individuals experience more health issues. Low health literacy and a high treatment burden may potentially exacerbate these issues.