Patient Support Program Research Articles

Effect of a cardiovascular post discharge sms support program on healthcare utilisation - the hearthealth program

Abstract Background Cardiovascular disease (CVD) is a leading cause of mortality worldwide[1]. Targeting modifiable risk factors is key to primary and secondary prevention of CVD but many barriers to good risk factor control exist[2]. SMS message programs have shown to be an efficient modality to deliver information to improve knowledge and risk factor profiles for CVD patients[3]; however, their impact on healthcare utilisation has not been thoroughly examined. The HeartHealth program is a text message post-discharge support program delivered to CVD patients. It comprised regular semi-personalised text messages providing CVD information, advice, and support to patients over a 6-month period. Purpose This study aimed to examine the impact of the Heart Health program on healthcare service utilisation. Methods Patients ≥18 years old who recently attended cardiology clinics or were discharged from a cardiology unit, between April 2020 and April 2022 were invited to the program. We compared healthcare utilisation rates in patients who enrolled into the HeartHealth text program (intervention group) to contemporaneous patients who did not enrol in the program (control group). The primary outcome was the incidence rate of all-cause healthcare utilisation events (composite of ED presentations and/or hospital admissions for any medical cause) in the 6 months post-discharge. The secondary outcomes were incidence rates of CVD events and unplanned CVD events. All analyses were adjusted for demographic and co-morbidity variables. Results 11542 patients were included in analysis (intervention: 4324, control: 7218), mean age 58.8 years, 60.7% were male, and 78.3% with English as their preferred language. HeartHealth Intervention participants had lower rates of the primary outcome of healthcare service events compared to control participants (mean number of events 0.43 intervention vs 0.52 control, adjusted rate ratio [RR], 0.91 [95% CI, 0.83-0.99], p=0.033, Table 1). The intervention was significantly more effective in older patients compared to younger patients (RR, 0.82, [95% CI, 0.72-0.93] in patients aged ≥65 years, compared to patients <65 years, RR, 0.98, [95% CI, 0.87-1.10]; p-value for interaction =0.043, Figure 1). The subset of CVD events and unplanned CVD events were numerically lowering in the intervention group compared to the control, but the risk ratio not statistically significantly different in adjusted models (Table 1). Conclusion This analysis demonstrates that a text message post-discharge support program for CVD patients decreased the need for healthcare service utilisation for all medical causes. Future randomised controlled trials are required to further support these findings.Figure 1:Adjusted interaction analysisTable 1:Adjusted Incidence of events

Provider Perspectives, Barriers, and Improvement Strategies for Hospital Discharge Support Programs: A Focus Group Interview Study.

Transitional periods, such as patient discharge, are notably challenging. This study aimed to explore the perceptions of providers involved in hospital discharge support programs, identify the primary obstacles, and propose strategies for improvement. In this qualitative cross-sectional study, we interviewed 49 healthcare professionals, comprising doctors, nurses, and social workers, who participated in two pilot programs. We organized focus group interviews with 3-6 participants per group, segmented by the type of discharge support program and profession. For data analysis, we employed phenomenological analysis, a qualitative method. Participants recognized the importance of the discharge support program and anticipated its benefits. The Rehabilitation Hospital Discharge Patient Support Program saw more active involvement from doctors than the Establishment of a Public Health-Medical Collaboration System program. Both programs highlighted the critical need for more staff and better compensation, as identified by the doctors. Nurses and social workers cited the heavy documentation burden, uncooperative attitudes from patients and local governments, and other issues. They also anticipated that program improvements could be achieved through the standardization of regional welfare services and better coordination by local governments serving as welfare service regulators. All groups-doctors, nurses, and social workers-underscored the significance of promoting these programs. Discharge support programs are crucial for patients with functional impairments and severe illnesses, particularly in ensuring continuity of care. Policy support is essential for the successful implementation of these programs in South Korea.

Prostate cancer survivorship of Australian men living with prostate cancer: Patient support programs in Australia.

Treatment for prostate cancer (PC) is associated with adverse effects, especially in patients receiving androgen deprivation therapy (ADT). The Australian Government, non-governmental organisations and pharmaceutical companies responsible for marketing ADT have initiated and sponsored various strategic support programs for patients diagnosed with PC. This professional article provides an overview of available PC patient support programs in Australia to assist general practitioners (GPs) to direct patient referrals and optimise clinical care. These PC support programs provide useful assistance on educational materials, decision support, clinical care management and referral to specialised services (eg continence advice, sexual health counselling and psychological support). More concerted efforts and smarter investment in PC survivorship programs are necessary to engage, educate and improve the lives of men living with PC more effectively.

Patients’ and stakeholders’ experiences of a personalized self-management SUPport program (P-SUP) for patients with type 2 diabetes mellitus and/or coronary heart disease: a qualitative process evaluation

BackgroundChronic diseases such as type 2 diabetes mellitus and coronary heart disease cause medical, social, and economic burdens worldwide. Disease management programs in Germany mostly lack components to improve patients’ self-management and health-promoting lifestyles despite clear guideline recommendations. Therefore, a Personalized Self-Management Support Program (P-SUP) was developed, which includes: (1) peer support groups; (2) telephone coaching; (3) feedback reports and, (4) a web portal. This study aims to explore patients’ and implementing stakeholders’ experiences in the implementation of P-SUP to identify barriers and facilitators to the implementation of the intervention.MethodsA qualitative study was conducted using face-to-face focus group interviews with participating patients and telephone-based one-to-one expert interviews with implementing stakeholders, involved in the delivery of the intervention. The transcribed interview reports were analyzed using qualitative content analysis, and the contents were categorized according to Donabedian’s Structure-Process-Outcome framework.ResultsA total of six themes among patients (N = 35) and five themes among implementing stakeholders (N = 32) represent the experiences. The patient themes were: (1) technical conditions, (2) indoor facilities, (3) group composition, (4) acceptance of digital components, (5) supervision and feedback and (6) impact on lifestyle behavior. The themes among the implementing stakeholders were: (1) multiprofessional approach, (2) human resources, (3) patient acceptance, (4) supervision and feedback and (5) impact on lifestyle behavior.ConclusionsMultiprofessional interventions such as P-SUP appear to be valuable for patients and implementing stakeholders. Although infrastructural barriers made the implementation of peer support and digital patient education difficult, patients rated the exchange with peers and experts on health-related topics positively. The lack of supervision and feedback during the course of the intervention might be compensated by regular telephone coaching. The findings from this study can be used in future studies to guide researchers and implementing stakeholders and to improve the feasibility and effectiveness of complex interventions in different contexts.Trial registrationThe P-SUP study was registered in the German Clinical Trials Register (DRKS) on 16/07/2020 under the registration number DRKS00020592.

Outcomes of a patient support programme for subcutaneous immunoglobulin therapy in patients with primary or secondary immunodeficiencies or chronic inflammatory demyelinating polyneuropathy.

Subcutaneous immunoglobulin (SCIg) therapy is important in the treatment of primary (PID) and secondary immunodeficiencies (SID) and chronic inflammatory demyelinating polyneuropathy (CIDP). Patient support programmes (PSPs) help patients self-administer medication regimens and play a more active role in the self-management of their medical conditions. To describe the effectiveness of the CSL Behring CARES PSP in optimising the quality use of SCIg in a hospital-free environment. This retrospective, observational study analysed records of patients enroled in the CSL Behring CARES PSP. Key outcomes were accessibility and effectiveness. Data were extracted from the patient database and analysed using descriptive methods. Seven hundred eighty-nine patients with PID (30.8%), SID (53.4%) and CIDP (15.8%) were enroled in the CARES PSP, 92.8% of whom were referred from public hospitals and the remaining from private hospitals. Of the total patient population, 697 (88.3%) received the nurse-led SCIg self-administration training and education (COACH), out of which 656 (94.1%) completed training and achieved competency after an average of 2.3 training sessions. The proportions of patients who achieved competency were similar across age groups and prior SCIg hospital education status. This is the largest real-world evidence study that describes the effectiveness of SCIg PSPs across three therapeutic disease states. These PSPs can optimise hospital resources such as infusion nurse time and allocation of infusion chairs that were once used for intravenous immunoglobulin infusions, improve patient access to SCIg therapy and enable patients self-administer SCIg outside a hospital environment.

Improving health behaviours and attitudes around podoconiosis in Northern Western Ethiopia: Implementation and intervention effectiveness.

Assessing how interventions are implemented is essential to understanding why interventions may or may not achieve their intended outcomes. There is little evidence about how interventions against Neglected Tropical Diseases (NTDs) are being implemented. Guided by the Context and Implementation of Complex Intervention (CICI) framework, we evaluated an ongoing intervention against the NTD podoconiosis to examine the implementation process and its effectiveness in terms of improving shoe wearing practices, increasing knowledge and reducing stigmatizing attitudes towards podoconiosis in rural Ethiopia. We employed an exploratory mixed methods approach, qualitative followed by quantitative, between April and July 2022 to assess implementation agents, theory, strategy, process and outcomes of the intervention. We conducted document analysis, observations, focus group discussions, in-depth interviews and key informant interviews for the qualitative phase. We administered a survey to 369 rural residents, of whom 42 were affected by podoconiosis. The implementers utilized government healthcare centers in a bid to mainstream podoconiosis services within local healthcare structures. The implementers provided training for health professionals and the public and distributed supplies to patients over a three-month period. The intervention reached 62% of patients, but female patients were less likely to participate than male patients. Only 18% of community members had participated in health education campaigns linked to the intervention. Involvement in the intervention resulted in improved shoe wearing practice and holding fewer stigmatizing attitudes. However, internalized stigma among patients was still rife; and the plan to utilize community assets to extend the intervention activities was not effective. Implementers must monitor the fidelity and progression of programs on a constant basis to make corrections. They also need to expand health education, provide psychosocial support and design economic empowerment programs for patients to reduce stigma. They must also collaborate with policy makers and international partners to sustain program activities at intervention delivery points.

Parichay Patient Support Program: Useful Tool for Improving Compliance in Kidney Transplant Recipients

IntroductionMedication non-adherence (MNA) in organ transplant recipients is associated with increased risk of rejection, allograft loss, patients’ death and higher healthcare costs. Various approaches have been used to reduce MNA. A patient support program (PSP) can be an invaluable tool in improving patient outcomes. Hence, the aim was to analyze available data of PSP for kidney transplant recipients. Material and MethodsA total of 3352 patients were prospectively enrolled in Parichay PSP between Jan 2021 - April 2023 from all over the country. Baseline demographic details were recorded. A monthly call was made thereafter. Data was analyzed for demographic details, compliance rate, drop-outs and tacrolimus levels (whenever available). This study was supported by Biocon Biologics. ResultsParichay program had enrolled a total of 1371, 1620 and 361 kidney transplant patients in years 2021, 2022 and 2023 (Jan-April) respectively from different parts of India (N-25%, E-35%, S-26%, W-14%). Patients who had received Tacrolimus (Tacrograf®) (n=2626) revealed that 2158 (82%) patients were male with the mean age of 42 years. Majority (61%) of patients were in age group of 28-48 years. Patient compliance rate of >90% was maintained for over 13 months (n = 1920, April 2022 - April 2023). Of the 3352 patients, 250 (7.4%) dropped out of the study. Thus, use of PSP ensured a compliance of 92.6% in our study. ConclusionsThis analysis demonstrates that participation in the PSP can be a useful tool to monitor compliance and tacrolimus therapeutic drug monitoring in kidney transplant recipients.

Summary of the best evidence for nutritional support programs in nasopharyngeal carcinoma patients undergoing radiotherapy.

To evaluate and summarize the best evidence for nutritional support in patients receiving radiotherapy for nasopharyngeal carcinoma and to offer guidance for clinical practice. Patients with nasopharyngeal carcinoma undergoing radiotherapy often experience a high prevalence of malnutrition, and there is a lack of compiled guideline recommendations, which complicates the provision of a reference for clinical nursing. A systematic literature search revealed the best evidence of nutritional support for nasopharyngeal carcinoma patients undergoing radiotherapy. Included in the review were various types of literature, such as clinical guidelines, expert consensus, systematic evaluations, meta-analyses, evidence summaries, and original studies. The evidence was graded according to the Australian Joanna Briggs Institute Centre for Evidence-Based Health Care Evidence Pre-Grading System (2016 version). Data were gathered from a range of sources, including BMJ Best Practice, the Scottish Intercollegiate Guidelines Network, the Cochrane Library, Embase, PubMed, Web of Science, CINAL, CNKI, the WanFang database, SinoMed, the Yi Maitong Guidelines Network, Dingxiangyuan, the Chinese Nutrition Society, the European Society for Clinical Nutrition and Metabolism website, and the American Society for Parenteral and Enteral Nutrition website. The search spanned from January 2013 to 2023. A comprehensive review identified a total of 3,207 articles, comprising six guidelines, eight expert consensus articles, four systematic evaluations, five randomized controlled trials, two cohort trials, and two observational studies. From these articles, we synthesized 63 pieces of evidence spanning six domains: nutritional risk screening and assessment, nutrient requirements, nutritional support, management of nutritional symptoms, functional exercise, and nutritional monitoring and follow-up. A total of lines of evidence supporting nutritional support for nasopharyngeal carcinoma patients receiving radiotherapy were summarized. However, the evidence should be combined with the actual clinical situation, and it should be validated in the future by combining large-sample and multicenter studies to provide a more scientific and beneficial nutritional support program for nasopharyngeal carcinoma patients receiving radiotherapy.

Qualitative Interviews Exploring Adverse Event Mitigation Strategies in Adults Receiving Amikacin Liposome Inhalation Suspension.

This study aimed to gain insight from patients with refractory Mycobacterium avium complex lung disease (MAC-LD) into strategies used to manage adverse events (AEs) associated with amikacin liposome inhalation suspension (ALIS). We conducted semi-structured interviews with US patients with refractory MAC-LD prescribed ALIS in a real-world setting. Interview transcripts were analyzed and coded to identify patterns in participants' descriptions of their ALIS treatment experiences, including AEs and their disruptiveness, and AE mitigation strategies, including participants' ratings of strategies' effectiveness. Concept saturation was also assessed. Twenty participants (mean age 48.7years; 80% women; mean ALIS duration 5.45months) were interviewed. At the time of the interview, 15 participants (75%) had received ALIS for > 1month and 13 (65%) were currently receiving ALIS. Participants described 44 unique AE mitigation strategies, which can be categorized into three groups: prepare for treatment; prevent increased emergence of AEs; and persist on treatment by mitigating AEs. Common strategies (reported by ≥ 50% of participants) included use of educational materials from the patient support program, localized management of throat irritation, and symptom management to reduce fatigue. Evidence of concept saturation was observed: no new strategies were identified in the last five interviews, which suggests the sample was robust enough to identify all mitigation strategies likely to be used by the broader patient population. This real-world study identified a diverse set of potential AE mitigation strategies intended to help individual patients prepare for ALIS treatment, prevent the increased emergence of certain AEs, and mitigate the impact of AEs on treatment persistence. Developing a comprehensive accounting of the types of mitigation strategies in use among patients in real-world settings can inform future investigation of the effectiveness of such strategies, and support evidence-based recommendations for treatment management.

Optimizing patient (pt) care through pt-focused resources to prevent and manage hand-foot skin reaction (HFSR).

e24144 Background: Research has shown that pts and caregivers (non-HCPs) seek medical and disease-related information more than once a month, and this has accelerated due to the COVID-19 pandemic. However, they find it difficult to understand the information they receive and thus, can be misinformed. By understanding the use of fair-balanced medical information (MI) resources by non-HCPs, pharmaceutical companies can develop scientifically accurate yet pt-friendly resources to meet their needs (Goettner, 2022; Rai, 2022). Upon reviewing the unsolicited oncology inquiries received by our MI department, approximately 25% of inquiries were from non-HCPs seeking information. Over the past 3 years, non-HCPs have submitted almost 10,000 inquiries regarding our oncology products, in which 191 inquiries were specifically regarding HFSR and regorafenib and sorafenib. Historically, our MI department responded to non-HCP inquiries by sharing the product label information. However, we identified an unmet need for trustworthy, comprehensive, and accurate pt resources in plain language. Methods: A full literature review was performed, and the relevant data were summarized in plain language for pts. Both HCPs and pts participated in developing the global pt resource on the prevention and management of HFSR for regorafenib and sorafenib. The seven-page interactive brochure was written in 4th to 6th grade reading level which included images and graphics to enhance the understanding of data, easy navigation to the content of interest, and glossary to define key terms. Furthermore, these materials were translated for pts who participated in the regorafenib and sorafenib Patient Support Program in Brazil to further educate and support pts who have started therapy. Results: As of June 2023, the global pt medical resource has been deployed 28 times in Brazil, delivering key information to non-HCPs on their disease and treatment while emphasizing its practical utility and addressing health literacy challenges. We collected feedback from pts who utilized the translated material, and they described it to be “informative” and “helpful” since it empowered them to effectively navigate and address HFSR-associated discomforts during their treatment journey. The feedback has also been utilized to further enhance the resource’s feasibility. Conclusions: The pt feedback on the brochures showcases the value of pt-focused approach in oncology and the positive impact of collective efforts across all stakeholders including pts, pharmaceutical MI departments and pt programs. Furthermore, it demonstrates how MI can bridge the gap between pt insights and clinical knowledge by addressing their needs and providing practical and trustworthy tools. Not only does this initiative enhance pt understanding but also empowers pts to take a more active role in their treatment and fosters shared-decision making.

Establishment of in-hospital nutrition support program for middle-aged and elderly patients with acute decompendated heart failure

ObjectiveTo construct a nutrition support program for middle-aged and elderly patients with acute decompensated heart failure (ADHF) during hospitalization.MethodsBased on the JBI Evidence-Based Health Care Model as the theoretical framework, the best evidence was extracted through literature analysis and a preliminary nutrition support plan for middle-aged and elderly ADHF patients during hospitalization was formed. Two rounds of expert opinion consultation were conducted using the Delphi method. The indicators were modified, supplemented and reduced according to the expert’s scoring and feedback, and the expert scoring was calculated.ResultsThe response rates of the experts in the two rounds of consultation were 86.7% and 100%, respectively, and the coefficient of variation (CV) for each round was between 0.00% and 29.67% (all < 0.25). In the first round of expert consultation, 4 items were modified, 3 items were deleted, and 3 items were added. In the second round of the expert consultation, one item was deleted and one item was modified. Through two rounds of expert consultation, expert consensus was reached and a nutrition support plan for ADHF patients was finally formed, including 4 first-level indicators, 7 s-level indicators, and 24 third-level indicators.ConclusionThe nutrition support program constructed in this study for middle-aged and elderly ADHF patients during hospitalization is authoritative, scientific and practical, and provides a theoretical basis for clinical development of nutrition support program for middle-aged and elderly ADHF patients during hospitalization.

Improvement in quality of life after asfotase alfa treatment in adults with pediatric-onset hypophosphatasia: data from 5 patient-reported outcome measures.

Hypophosphatasia (HPP) is a rare, inherited metabolic disorder caused by deficient tissue-nonspecific alkaline phosphatase activity. This study assessed the impact of treatment with asfotase alfa on patient-reported outcomes (PROs) in adults with pediatric-onset HPP. A longitudinal, telephone-based survey was administered to eligible individuals enrolled in a patient support program. Interviews were conducted at study entry (prior to asfotase alfa initiation) and after 3, 6, and 12mo. PROs-Patient Health Questionnaire-9 [PHQ-9], Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [WPAI:SHP], Patient-Reported Outcomes Measurement Information System 29 [PROMIS-29], and Routine Assessment of Patient Index Data 3 [RAPID3]-were assessed at each time point. Appropriate statistical tests were performed to assess score changes. Among 50 enrolled patients (mean age: 46yr [SD: 15.4]; 80% female; 94% White), 49 were evaluable at 3mo, 44 at 6mo, and 29 at 12mo. By month 3, statistically significant improvements from baseline were detected in PHQ-9 scores (10.6 vs 5.8 [P <.0001]), PROMIS-29 domain scores (overall physical function: 38.0 vs 43.0 [P =.001]; anxiety: 57.5 vs 51.5 [P =.0011]; fatigue: 63.3 vs 55.3 [P <.0001]; sleep disturbances: 58.8 vs 54.3 [P =.0099]; ability to participate in social roles and activities: 42.6 vs 47.7 [P =.0012]; and pain interference: 63.8 vs 58.4 [P =.001]), and RAPID3 domain scores (functional status: 2.7 vs 1.1 [P <.0001]; pain tolerance: 6.0 vs 3.2 [P <.0001]; and global health estimate: 5.1 vs 2.7 [P <.0001]). Improvements persisted at month 12. Patients also showed improvements in WPAI:SHP domain scores at month 6 (presenteeism: 39.6% vs 14.1% [P <.0001] and work productivity loss: 41.9% vs 14.1% [P <.0001]). Treatment with asfotase alfa was associated with improved quality of life across several domains.

Shared decision-making support program for older patients with advanced cancer using a question prompt list and geriatric assessment: A pilot randomized controlled trial

IntroductionOlder patients with cancer are less likely to express their treatment preferences than younger patients. Question prompt lists (QPLs) facilitate communication between patients and physicians. Geriatric assessment (GA) is recommended when older patients with cancer make treatment decisions. This study estimated the effect size of a shared decision-making (SDM) support program combining QPLs with GA in terms of patients' subjective evaluation of the SDM process for a future definitive randomized controlled trial. We also evaluated the number and quality of aging-related communication during consultations, and feasibility and acceptability of the study for exploratory purposes. Materials and MethodsThis is a pilot study with randomized allocation and blind evaluation. Patients aged 65 years or older at the National Cancer Center Hospital, Tokyo, Japan, scheduled to discuss the changes of their treatment, were randomly assigned in a 1:1 ratio to the SDM support program or usual care. This program consisted of 30–60 min of face-to-face coaching, with QPLs and GA provided before the coaching. As the primary endpoint, the decisional conflict scores given by the patients immediately after the consultation were compared between the two groups. For the secondary endpoints, the number and quality of aging-related communications during the consultations were assessed by evaluators (blinded) using audio-recordings. Adherence, burden, and usefulness were assessed for evaluating feasibility and acceptability of the SDM support program. ResultsForty patients were enrolled. All patients completed the GA questionnaire, for which 70% did not require any individual assistance. Answering the questionnaires took approximately 11 min. The decisional conflict scores were mean [standard deviation (SD)]: 19.3 [10.8] vs. 18.0 [11.1] (effect size: Cohen's d = 0.12) for the SDM support program and usual care groups, respectively. The number of aging-related communications during the consultation for the new treatment was higher in the SDM support program group than the usual care (mean [SD]: 3.3 [1.2] vs. 2.2 [1.5], effect size: cohen's d = 1.32). Patients felt that the SDM support program was useful but not burdensome or difficult. DiscussionThe SDM support program was considered useful and feasible for older patients and able to facilitate communication regarding aging-related concerns. Trial registration numberThe study protocol was registered on September 23, 2020, in the UMIN Clinical Trials Registry (UMIN000041867).

Using spirometry for screening and diagnosis of chronic respiratory diseases in primary health care: findings from a community health project in rural India

Background Chronic respiratory diseases (CRDs) such as Chronic obstructive pulmonary disease (COPD), Asthma and post-tuberculosis lung disease (PTLD) are a growing public health concern in India. Early diagnosis and management of CRDs require a good quality spirometry test, a technician to conduct spirometry and a chest physician to interpret the results. In India, these are not available at the primary care level. This study reports the feasibility of a large-scale CRD diagnosis and management program in primary care using a unique point-of-care spirometry solution, Briota PFT in a Box™. # Methods A community-based cross-sectional study was conducted among 15,602 adults in Dindori Taluka (subdivision), Nashik, Maharashtra state. This study was part of a holistic CRD diagnosis and management program SAVE™ (Spirometry Assisted Virtually Early). Make In India point of care solution Briota PFT in a Box™ was used. A House‐to‐house community-based assessment checklist (CBAC) survey, 4-parameter spirometry test, 15-parameter pre and post-bronchodilator spirometry test and a software-assisted medical examination by the medical officer at primary care were conducted. Software was used to generate CRD diagnosis and lung health score (LHS™). The diagnosis was verified by the chest physician. Confirmed diagnosed patients were provided treatment and offered a patient support program. Interviews were conducted with the patients, nurses, doctors and public health officials for understanding feasibility and documenting learning from program SAVE™. # Results Out of 15,602 adults surveyed, total 4,937 (31.6%) were identified as “CRD high risk”. 1231 participants based on medical examination, spirometry tests and software analysis were identified as CRD candidates by medical officers at primary care. 1154 participants out of 15,602 (7.4%) were confirmed diagnosed as CRD patients post independent evaluation by chest physicians. At the time of follow-up, 537 patients (75% of 712 patients enrolled in patient support program) reported improvement in symptoms and high satisfaction with the program. District health officer, Medical officers, nurses, Accredited Social Health Activist (ASHA) from the primary health care centers confirmed ease of use and feasibility of using Briota PFT in a Box™ in program SAVE™. Outcome and learning from program SAVE™ was documented and submitted to Ministry of Health and Family Welfare Government of India. # Conclusions CRD diagnosis and management in large scale settings in primary healthcare level using a point of care spirometry solution Briota PFT in a Box™ is highly feasible.

P067 Support Programme for Patients Receiving Imraldi or Benepali Therapy for Immune-Mediated Inflammatory Disorders: 12-Month Persistence

Abstract Background/Aims Low persistence to long-term therapy for chronic disease is a recognised problem. Evidence suggests that increasing patients’ ability to manage their own health condition may positively impact adherence and persistence, leading to improved clinical outcomes. In 2019, Biogen initiated a patient support programme (PSP), in addition to the pre-existing medication home delivery (‘homecare’) service, to improve the knowledge, skills and confidence of patients self-administering Imraldi (adalimumab ADL) and Benepali (etanercept ETN). Methods This real-world, retrospective, database study includes patients enrolled into the PSP within 12 months of ADL/ETN initiation. At first ADL/ETN administration all patients receive a face-to-face nurse training visit, followed by a second nurse training visit or follow-up call to coincide with the second injection. Following this, patients consenting to enrol in the PSP receive nurse coaching calls at Weeks 3, 10, 22 and 34, whilst non-PSP patients self-manage thereafter. The analysis presented here excludes patients who were enrolled into the PSP more than 12 months after ADL/ETN initiation. Data including demographics and type/duration of ADL/ETN therapy was captured by the homecare provider for the PSP cohort from November 2019 to February 2022, and for the non-PSP cohort between February 2016 (ETN) or November 2018 (ADL) and February 2022. Persistence at 12 months post-initiation was estimated using Kaplan-Meier (KM) techniques, overall and by subgroup including indication (rheumatology, dermatology, gastroenterology) and whether biologic naïve or switched from another biologic. Results Persistence at 12 months for patients enrolled in the PSP was 77.5% and in the non-PSP cohort was 73.6%. Lowest persistence by prior biologic exposure was 70.9% in the non-PSP biologic naïve cohort. By therapeutic area, the greatest differential between PSP vs non-PSP group (75.7% vs 67.6%) was in the gastroenterology cohort, which also had the lowest non-PSP persistence of any subgroup. (Table) Conclusion Compared to the non-PSP cohort, patients enrolled in the PSP had higher persistence at 12 months after initiation, across all indications and regardless of prior biologic exposure. This real-world evidence indicates the benefits of a PSP to patients with chronic diseases, and that particular attention should be paid to biologic-naïve patients. Disclosure A. Clark: Corporate appointments; AC is an employee of Biogen Idec Ltd. T. Shering: Corporate appointments; TS is an employee of Biogen Idec Ltd. J. Addison: Corporate appointments; JA is an employee of Biogen Idec Ltd.

Baseline characterization of a cohort of colombian patients with chronic rhinosinusitis with nasal polyps

To present the baseline clinical and demographic characteristics of CRSwNP patients over the age of 18 enrolled in a Patient Support Program (PSP) prior to biologic treatment. Descriptive, cross-sectional study performed in a Colombian CRSwNP asthma PSP sponsored by Sanofi from Aug-2021 to Jul-2022. Data was collected from CRSwNP patients, prior to the start of Dupilumab treatment, who consented to the use of their data. The following information was reported: Age, reporting city, treating medical specialty, comorbidities, and persistence of treatment. 339 patients were included, 171 (50,4%) were women and 168 (49,6%) were men. The mean age at Dupilumab treatment initiation was 52,4 years. 62,8% began treatment during adulthood (26-59y), while 34.1% started at elderly (+60y) and 3.1% were young adults (18-25y). Most cases (29,7%) were included in Bogotá, followed by Antioquia (19%), Valle del Cauca (7,3%) and the remaining 44% nationwide. Comorbidities were present in 67,1% of the patients, with diagnosis of allergic rhinitis, atopic dermatitis, asthma, and other non-type 2 inflammatory diseases. Nasal surgical history was present in 89,6% of the patients, most of them with one to three previous surgeries. Continuous treatment was observed in 70,3% of patients for 6 to 12 months, in 21,3% for more than 12 months and in 8,4% for less than six months. The most frequently treating medical specialty was otorhinolaryngology (79,6%), followed by allergology (16%) and other medical professionals (4,4%). There is concordance with the literature on a higher presentation of the disease in women than in men. There is a large proportion of patients with nasal surgical history and type 2 inflammatory comorbidities by the moment of biologic treatment initiation. The care and identification of CRSwNP colombian patients is mainly provided by otorhinolaryngologists, followed by allergologists.

A machine-learning algorithm using claims data to identify patients with homozygous familial hypercholesterolemia

Homozygous familial hypercholesterolemia (HoFH) is an underdiagnosed and undertreated ultra-rare disease. We utilized claims data from the Komodo Healthcare Map database to develop a machine-learning model to identify potential HoFH patients. We tokenized patients enrolled in MyRARE (patient support program for those prescribed evinacumab-dgnb in the United States) and linked them with their Komodo claims. A true positive HoFH cohort (n = 331) was formed by including patients from MyRARE and patients with prescriptions for evinacumab-dgnb or lomitapide. The negative cohort (n = 1423) comprised patients with or at risk for cardiovascular disease. We divided the cohort into an 80% training and 20% testing set. Overall, 10,616 candidate features were investigated; 87 were selected due to clinical relevance and importance on prediction performance. Different machine-learning algorithms were explored, with fast interpretable greedy-tree sums selected as the final machine-learning tool. This selection was based on its satisfactory performance and its easily interpretable nature. The model identified four useful features and yielded precision (positive predicted value) of 0.98, recall (sensitivity) of 0.88, area under the receiver operating characteristic curve of 0.98, and accuracy of 0.97. The model performed well in identifying HoFH patients in the testing set, providing a useful tool to facilitate HoFH screening and diagnosis via healthcare claims data.

REBISTART: Adherence of Patients with Multiple Sclerosis to Treatment with Subcutaneous Interferon Beta in the Context of a Patient Support Program.

Treatment adherence is a critical success factor in the disease-modifying therapy (DMT) of multiple sclerosis (MS). The REBISTART study prospectively evaluated adherence in patients using components of a patient support program (PSP). The 12-month non-interventional multicenter study examined the real-world adherence to subcutaneously (sc) injected interferon beta-1a (Rebif®). Patient-assessed adherence was measured by a visual analog scale (VAS) and the Morisky Medication Adherence Scale (MMAS). Objective adherence data were obtained by readouts from the RebiSmart® injection device. Of 333 patients, 70.9% used the nursing service as the core component of the PSP. Self-assessed VAS-based adherence was stable over time at 94.0-96.3%. Similarly, MMAS score (maximum 4) was 3.8-3.9 at all visits, also reflecting high self-assessed adherence. In 269 patients using the RebiSmart® injection device, mean readout-based objective adherence was similarly high (93.0-98.4% throughout visits). At last available visit, VAS-based adherence was independent of participation in the PSP nursing service (93.1% with participation versus 91.7% without it). Adherence was also independent of injection method or disease-related measures, including fatigue, depression, cognition, and quality of life. The most frequent reason for the premature discontinuations (38.7% of patients) was "change of treatment" (10.0%). We suggest that subgroups that may specifically benefit from PSP include patients who live alone, use multiple comedications, and are affected by cognitive impairment, depression, and/or fatigue. Further studies should investigate the potential usefulness of PSPs in these populations. Very high adherence rates independent of the PSP nursing service over 1year of treatment indicate that IFN beta-1a sc is an easy-to-use and well-tolerated disease-modifying drug. Vfa.de: No. 892. https://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_892 .

The relationship among vedolizumab drug concentrations, biomarkers of inflammation, and clinical outcomes in a Canadian real-world study.

Therapeutic drug monitoring is used to optimize anti-tumour necrosis factor biologic effectiveness in inflammatory bowel disease, but its role with other biological classes is unclear. This study explores relationships between post-induction vedolizumab trough concentrations and biochemical outcomes in a real-world study of individuals with inflammatory bowel disease. This retrospective analysis of data from a national patient support program between 2018 and 2020, included 436 individuals with Crohn's disease or ulcerative colitis receiving vedolizumab. Optimal vedolizumab concentration thresholds (at weeks 6 and 14) were determined based on their ability to predict biochemical normalization (week 30 faecal calprotectin [<250 µg/g], C-reactive protein [<5 mg/l]). Thresholds best associated with each outcome were evaluated in multivariate analyses. Among patients with Crohn's disease, week 6 serum vedolizumab concentrations (>41.65 µg/ml) predicted normalization defined by C-reactive protein: Spearman correlation coefficient [ρ] = -0.26, P = 0.002 and multivariate analysis (MVA)-OR: 3.22, 95% CI: 1.32-7.87, P = 0.01, and at week 14 (>22.25 µg/ml): ρ = -0.38, P < 0.0001, and MVA-OR: 3.21, 95% CI: 1.26-8.17 but not faecal calprotectin. Similarly, among patients with ulcerative colitis, week 6 vedolizumab concentrations (>39.65 g/ml) predicted normalization defined by C-reactive protein: ρ = -0.26, P = 0.005 and MVA-OR: 4.03, 95% CI: 1.30-12.52, P = 0.016, and at week 14 (>17.35 µg/ml): ρ = -0.39, P = 0.0001 and MVA-OR: 6.95, 95% CI: 1.81-26.77, P = 0.005, but not faecal calprotectin. Induction and post-induction serum vedolizumab were not consistently associated with biochemical normalization. As such, proactive therapeutic drug monitoring for vedolizumab should not be routinely incorporated in a treat to target strategy for inflammatory bowel disease. NCT04567628.

Survival among patients receiving eteplirsen for up to 8 years for the treatment of Duchenne muscular dystrophy and contextualization with natural history controls.

Eteplirsen, approved in the US for patients with Duchenne muscular dystrophy (DMD) with exon 51 skip-amenable variants, is associated with attenuated ambulatory/pulmonary decline versus DMD natural history (NH). We report overall survival in a US cohort receiving eteplirsen and contextualize these outcomes versus DMD NH. US patients with DMD receiving eteplirsen were followed through a patient support program, with data collected on ages at eteplirsen initiation and death/end of follow-up. Individual DMD NH data were extracted by digitizing Kaplan-Meier (KM) curves from published systematic and targeted literature reviews. Overall survival age was analyzed using KM curves and contextualized with DMD NH survival curves; subanalyses considered age groups and duration of eteplirsen exposure. Overall survival time from treatment initiation was also evaluated. A total of 579 eteplirsen-treated patients were included. During a total follow-up of 2119 person-years, median survival age was 32.8 years. DMD NH survival curves extracted from four publications (follow-up for 1224 DMD NH controls) showed overall pooled median survival age of 27.4 years. Eteplirsen-treated patients had significantly longer survival from treatment initiation versus age-matched controls (age-adjusted hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.44-0.98; p < .05). Longer treatment exposure was associated with improved survival (HR, 0.15; 95% CI, 0.05-0.41; p < .001). Comparisons using different DMD NH cohorts to address common risks of bias yielded consistent findings. Data suggest eteplirsen may prolong survival in patients with DMD across a wide age range. As more data become available, the impact of eteplirsen on survival will be further elucidated.