Unmet Needs Research Articles

Unmet Clinical Needs in Women with Aesthetic Manifestations of Polycystic Ovary Syndrome: A Cross-Sectional Study.

Background: Polycystic ovary syndrome (PCOS) management has hardly been standardized until recent years. There is an accurate, evidence-based guideline published by the European Society of Human Reproduction and Embryology (ESHRE). However, it remains unclear to which extent, if at all, the guideline is followed by health care providers. The aim was to explore the subjectively perceived quality of gynecological medical care in women with PCOS suffering from aesthetic complaints. Materials and Methods: A nonvalidated questionnaire was constructed in a standardized manner covering the domains: aesthetic aspects, metabolism, menstrual cycle, reproduction, mental health, and prevention of chronic noncommunicable diseases. Results: A total of 1960 participants with aesthetic complaints, such as acne (66.2%), alopecia (43.9%), hirsutism (77.9%), or overweight/obesity (72.3%) were included. The percentage of women being counseled was low (acne 20.3%, alopecia 12.9%, hirsutism 17.5%, overweight/obesity 36.2%). Satisfaction with counseling was moderate (40.4-44.1 points). Many women tried at least one therapeutic method (75.9%), whereas only a few were counseled for therapy (acne 27.0%, alopecia 24.6%, hirsutism 24.0%, overweight/obesity 18.8%) with moderate satisfaction for hyperandrogenism (mean 55.1-59.5 points) and good satisfaction for overweight/obesity (mean 60.8 points). Overall satisfaction was rated with a mean of 30.5 points (standard deviation 27.1) on a scale from 0 to 100 and thus considered "not satisfied." Fewer complaints were significantly correlated with higher satisfaction. Most women wished for more counseling (80.8%), as well as more diagnostic (63.2%) and therapeutic options (70.2%). Conclusions: Women affected by PCOS are not properly managed according to the ESHRE guideline. Indeed, this guideline recommends comprehensive history and physical examination for clinical hyperandrogenism as well as holistic approaches in therapy, including education and counseling of patients. Still, overall consultation rates and satisfaction were poor.

Adaptation and validation of the Longer-term Unmet Needs after Stroke (LUNS) monitoring tool in Sri Lanka

BackgroundGlobally, stroke is a leading cause of mortality and morbidity. Unmet needs are defined as expressed needs that are not fulfilled by services provided and are considered an important indicator of the adequacy and quality of stroke follow-up care. This study aimed to culturally adapt, modify, translate and validate, the Longer-term Unmet Needs after Stroke (LUNS) monitoring tool, to Sri Lanka. Currently, there is no validated tool in Sri Lanka to assess unmet needs among stroke survivors and unmet needs are not systematically assessed.MethodsA phased approach followed to culturally adapt, translate, establish its factorial validity and evaluate the convergent and divergent validity, reliability, and overall acceptability. The process of culturally adapting the tool was carried out using two rounds of the modified Delphi technique. The modified tool was translated to Sinhala and pretested among 10 stroke survivors. A descriptive cross-sectional study was conducted among 119 stroke survivors to establish the factorial validity and convergent and discriminant validity using the GHQ-12 and Barthel Index. The Socio-demographic characteristics of the study participants are presented. Communalities were assessed for 21 items and 2 items were dropped. Factor structure was confirmed with varimax and oblique rotations. The correlation coefficient was calculated to assess convergent and divergent validity. Cronbach’s alpha value was calculated to assess internal reliability.ResultsFollowing the modified Delphi technique, 5 items of LUNS tool were removed, and 5 items were modified. Three new items were added based on expert recommendation. One item related to driving also removed as it does not fit with the factor structure emerged. In establishing factorial validity 5 factors emerged from the exploratory factor analysis. In assessing the convergent and discriminant validity, test results revealed that both General Health Questionnaire-12 (GHQ-12) and Barthel Index significantly correlated as expected with unmet needs. The results of Cronbach’s alpha showed that all the factors were moderately high confirming the reliability of the tool.ConclusionsThe Sinhala version of the LUNS monitoring tool is a valid and reliable instrument to assess the unmet needs of stroke survivors. Assessment of unmet needs will add new insight into evaluation of the quantity, quality, and effectiveness of healthcare interventions received by stroke survivors in Sri Lanka.

Unmet Surgical Needs and Trust Deficit in Marginalized Communities in India: A Comparative Cross-Sectional Survey

IntroductionWe carried out a household study of surgical unmet needs and trust in the physician and perception of quality in the health system in a rural Tribal area and an urban slum in India. MethodsA community-based, cross-sectional study was carried out in a Tribal and in an urban slum in Gujarat, India. We surveyed 7914 people in 2066 households in urban slum and 5180 people of 1036 households in rural Tribal area. The Surgeons Overseas Assessment of Surgical need was used to identify surgical met and unmet needs. Two instruments for trust deficit ‘the Socio-culturally Competent Trust in Physician Scale for a Developing Country Setting’ and ‘Patient perceptions of quality’ were also administered to understand perception about healthcare. Frequencies and proportions (categorical variable) summarized utilization of surgical services and surgical needs. P < 0.05 was statistically significant. ResultsSlums and Tribal areas were significantly different in sociodemographic indicators. Unmet surgical needs in Tribal area were less than 5% versus 39% in the urban slum. Major need of surgery in Tribal area was for eye conditions in older population, while surgical conditions in extremities and abdomen were predominant in the urban area. Trust level was high for physicians in both areas. ConclusionsSurgical unmet needs were significantly lower in Tribal versus urban area, possibly due to high priority given by the Indian government to alleviate poverty, social deprivation and participation of NGOs. Our study will give impetus to study unmet surgical needs and formulation of health policies in India and low-and-middle- income countries.

Patient-reported unmet supportive care needs in long-term colorectal cancer survivors after curative treatment in an Asian population

Despite an increase in colorectal cancer (CRC) survival, less is known about CRC-specific long-term unmet supportive needs in Asian patients. This study aimed to examine the prevalence of long-term unmet needs and identify clinical and socio-demographic factors associated with increased unmet needs in Asian CRC survivors. We conducted a cross-sectional study that assessed unmet needs using the Cancer Survivors' Unmet Needs scale. CRC survivors of at least two years after undergoing curative surgery were recruited from an outpatient clinic of a large public hospital in Singapore. In total, 400 CRC survivors with a mean age of 64 and a median survival time post-surgery of 78 months participated in the study. Approximately half of patients (52%) reported at least one unmet need. Male gender (RR 1.19, p=0.01), age greater than 65 years (RR 0.63, p<0.0001), longer follow up of more than 5 years (RR 0.80, p=0.009), presence of a permanent stoma (RR 1.78, p<0.0001), prior radiotherapy in treatment course (RR 1.99, p<0.0001), higher educational status (RR 1.30, p=0.0002), currently employed (RR 0.84, p=0.014), currently married (RR 0.84, p=0.01) were significant predictors for increased unmet needs. There is a high prevalence of unmet needs in long-term Asian CRC survivors, which underscores the importance of screening patients to allow for early detection of unmet needs. Our findings on sociodemographic and clinical predictors can inform the development of targeted interventions tailored to the need domains and improvement of survivorship programmes.

Current Perceptions and Unmet Needs of People with Parkinson Disease and their Families

Purpose: A new diagnosis of Parkinson disease (PD) occurs every nine minutes in the United States. It is a multimodality neurogenic disorder whose prevalence is expected to only increase worldwide in the coming decades. Therefore, a systematic examination of the current perception of PD symptoms and the different unmet needs of people with PD and their families can allow healthcare professionals to design more effective education, awareness, and management programs. The current study examined perceptions of different PD-related symptoms among individuals with PD and care partners (including spouses and family members) living in different communities of the United States (including Oklahoma and surrounding regions).Methods: The study included 39 participants with PD and 11 care partners based in four states (including Arkansas, Kansas, Oklahoma, and Texas).Results: Findings indicated that participants with PD and care partners more frequently reported motor symptoms associated with PD than nonmotor and communication symptoms. In addition, specific to unmet needs, both groups reported the need for specialized services and educational resources related to PD symptoms in their respective communities.Conclusions: Overall, there is a need for more widespread education and access to specialized services specific to PD. Overall, findings from the study will help create more effective service delivery programs for individuals with PD and their families in different communities.

POSTER: CML-562 The Importance of Quality of Survivorship: US Results From the Chronic Myeloid Leukemia (CML) Survey on Unmet Needs (SUN)

POSTER: CML-562 The Importance of Quality of Survivorship: US Results From the Chronic Myeloid Leukemia (CML) Survey on Unmet Needs (SUN)

Factors Associated with Unmet Needs of Chronic Diseases in Kenya: Multilevel Analysis of Kenya Household Health Expenditure and Utilization Survey 2018

This study investigates the factors that contribute to unmet healthcare demands among people with chronic illnesses. The 2018 Kenya Household Health Expenditure and Utilization Survey, conducted by the Kenya National Bureau of Statistics, provided the extensive national sample used in this study, which provides information about the state of the healthcare system. A two-stage sample approach was used in the survey to pick 1,500 clusters and then identify twenty-five households inside each cluster, producing a total coverage of 37,500 households. This cross-sectional study looks at how factors interact in Kenya's 47 counties, both at the household and communal levels. The results highlight the significant impact of household characteristics, which account for 81% of the explanation for unmet healthcare needs, while factors at the community or county level account for 19%. These findings are consistent with macroeconomists' and health experts' viewpoints that health is a shared family asset. Interesting gender discrepancies show that women are more vulnerable than men because of their complex healthcare needs. Contrary to popular belief, married people face more difficulties getting access to healthcare. Economic status highlights the differences even more, with the poorest households facing the biggest difficulties. In line with earlier studies, access to healthcare remains a major barrier for rural inhabitants. This emphasises how urgently needed specialised healthcare treatments are in rural areas, particularly for those suffering from chronic diseases. The study shows a decrease in the likelihood of unmet healthcare needs in households with health insurance. It is particularly important to economically and socially empower the household head to invest in and prioritise healthcare needs since chronic diseases are almost a sure bet in every household, especially in the later years of an individual's life

CML-562 The Importance of Quality of Survivorship: US Results From the Chronic Myeloid Leukemia (CML) Survey on Unmet Needs (SUN)

CML-562 The Importance of Quality of Survivorship: US Results From the Chronic Myeloid Leukemia (CML) Survey on Unmet Needs (SUN)

The Unmet Needs of Caregiving Skills, Support, Emotions, and Finances of Stroke Caregivers: A Multicenter Study.

​​​​​​Background Informal stroke caregivers in Malaysia play an important role in supporting stroke survivors following acute care. Nevertheless, there is a lack of available data to inform the sufficiency of help and resources available to address the needs of local stroke caregivers. This study aimed to determine the unmet needs in caregiving skills, support, emotions, and finances as well as the associated factors of stroke caregivers in Malaysia. Methodology This multicenter, cross-sectional study used a self-administered survey developed and validated for the Malaysian population. It was prepared in paper-based and web-based formats, and it was distributed via direct contact with the respondents, post, and email. Respondents were recruited from different sites in Malaysia. In this study, unmet needs were defined as "help that was needed more or was not provided to assist caregivers and address their specific needs." This article only presents the quantitative data of this study. Data were analyzed using descriptive analysis and logistic regression to determine factors associated with unmet needs. Results Almost all study respondents (91%) reported having unmet needs. Unmet needs ranged from 1 to 10, while the mean unmet needs was 5. The highest unmet need was related to financial support (72.5%), followed by support from professionals to address their own needs (59.2%), skills to care for stroke survivors, i.e., skills in caring for stroke survivors with their daily activities (57.9%), and skills in supporting stroke survivors to perform rehabilitation at home (53.1%). The lowest unmet need was related to support in transporting stroke survivors from place to place (45.3%). Additionally, this study did not identify an association between the reported unmet needs and gender, age, ethnicity, duration of caregiving, and site of participation. Conclusions This study reported a range of unmet needs perceived by stroke caregivers in Malaysia. Further research is warranted to understand the gaps in supporting local stroke caregivers to inform future post-stroke support and services in the country.

Understanding the Under-Recognised Burden and Unmet Needs in Infants and Children with Respiratory Syncytial Virus

For this article, an interview was conducted by EMJ in June 2023 with key opinion leader, Lindsay Broadbent, Lecturer (Assistant Professor) in Virology in the Faculty of Health and Medical Sciences at the University of Surrey, Guildford, UK. Broadbent specialises in respiratory virus–host interactions and subsequent innate immune responses, and the role of respiratory viruses in longer-term lung damage and the development of chronic lung disease. In this interview, Broadbent discussed the global burden of respiratory syncytial virus (RSV), a virus spread by micro-droplets. Broadbent highlighted RSV as a major cause of hospitalisations, particularly in children under the age of 1 year, which can impose a significant burden on health, particularly in infants, and healthcare systems globally. Broadbent provided insights into the leading risk factors of RSV, and emphasised the need for preventative measures to mitigate severe infections. Additionally, Broadbent highlighted the importance of improving the diagnosis and treatment options to address the unmet medical needs related with RSV. They called for increased awareness of RSV, and understanding of why certain infants are more susceptible to severe disease.

Clustering Research Proposal Submissions to Understand the Unmet Needs ofMilitary Clinicians.

The Advanced Medical Technology Initiative (AMTI) program solicits research proposals for technology demonstrations and performance improvement projects in the domain of military medicine. Advanced Medical Technology Initiative is managed by the U.S. Army Telemedicine and Advanced Technology Research Center (TATRC). Advanced Medical Technology Initiative proposals span a wide range of topics, for example, treatment of musculoskeletal injury, application of virtual health technology, and demonstration of medical robots. The variety and distribution of central topics in these proposals (problems to be solved and technological solutions proposed) are not well characterized. Characterizing this content over time could highlight over- and under-served problem domains, inspire new technological applications, and inform future research solicitation efforts. This research sought to analyze and categorize historic AMTI proposals from 2010 to 2022 (n = 825). The analysis focused specifically on the "Problem to Be Solved" and "Technology to Demonstrated" sections of the proposals, whose categorizations are referred to as "Problem-Sets" and Solution-Sets" (PS and SS), respectively. A semi-supervised document clustering process was applied independently to the two sections. The process consisted of three stages: (1) Manual Document Annotation-a sample of proposals were manually labeled along each thematic axis; (2) Clustering-semi-supervised clustering, informed by the manually annotated sample, was applied to the proposals to produce document clusters; (3) Evaluation and Selection-quantitative and qualitative means were used to evaluate and select an optimal cluster solution. The results of the clustering were then summarized and presented descriptively. The results of the clustering process identified 24 unique PS and 20 unique SS. The most prevalent PS were Musculoskeletal Injury (12%), Traumatic Injury (11%), and Healthcare Systems Optimization (11%). The most prevalent SS were Sensing and Imaging Technology (27%), Virtual Health (23%), and Physical and Virtual Simulation (11.5%). The most common problem-solution pair was Healthcare Systems Optimization-Virtual Health, followed by Musculoskeletal Injury-Sensing and Imaging Technology. The analysis revealed that problem-solution-set co-occurrences were well distributed throughout the domain space, demonstrating the variety of research conducted in this research domain. A semi-supervised document clustering approach was applied to a repository of proposals to partially automate the process of document annotation. By applying this process, we successfully extracted thematic content from the proposals related to problems to be addressed and proposed technological solutions. This analysis provides a snapshot of the research supply in the domain of military medicine over the last 12 years. Future work should seek to replicate and improve the document clustering process used. Future efforts should also be made to compare these results to actual published work in the domain of military medicine, revealing differences in demand for research as determined by funding and publishing decision-makers and supply by researchers.

Unmet Clinical Needs for Transcatheter Pulmonary Valves.

A common feature of congenital heart disease is the presence of right ventricular outflow tract (RVOT) obstruction that can range from mild to severe and can lead to atresia of the pulmonary valve, in extreme conditions. RVOT abnormalities can frequently be corrected surgically or via interventional means. However, most of these patients will ultimately develop pulmonary valve insufficiency and eventual right ventricular dilation, which will require a pulmonary valve replacement at some point in their life to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). The evolution from the studies done by Philip Bonhoeffer to implant a pulmonary valve via transcatheter means, have provided a bedrock for transcatheter pulmonary valve replacement (TPVR). Yet, several areas of unmet need for a demographic of patients still exist. Here, we discuss the clinical unmet needs in children under 20 Kg and expand the use of hybrid and other TPVR approaches along with the current indications and contraindications for pulmonary valve replacement. The constraints and limitations from commercially available pulmonary valves will be discussed from a clinical standpoint. Finally, we explore the use of hybrid and periventricular delivery of transcatheter pulmonary valves in younger patients.

Unmet Needs and Barriers in Providing Hospital Care for Older Adults: A Qualitative Study Using the Age-Friendly Health System Framework.

This study aims to identify unmet needs and barriers for improving inpatient care for older adults at an academic hospital in Korea by using a qualitative focus group design and the Age-Friendly Health Systems (AFHS) framework. A total of 14 healthcare providers and employees participated in focus group interviews. Participants included medical doctors, registered nurses, a receptionist, a patient transporter, a pharmacist, a physical therapist, and a social worker. The data were analyzed qualitatively, as per the Consolidated Criteria for Reporting Qualitative Research guidelines. The analysis method encompassed a thematic framework analysis via the AFHS 4Ms framework, consisting of the four domains "What Matters", "Medication", "Mentation", and "Mobility". Multiple barriers and unmet needs were identified using the AFHS 4Ms framework in the provision of inpatient care for older adults at the hospital. The main barriers identified in the "What matters" domain are a lack of shared decision-making and individualized care plans, as well as economic and safety-conscious preferences among some older patients. In the "Medications" domain, the main barriers to providing adequate and safe pharmacotherapy include patient and caregiver-related factors, increased complexity of medication use, and lack of institutional support systems. In the "Mentation" domain, the main issues identified are communication barriers related to patients, caregiver factors, and insufficient delirium management due to a lack of adequate processes/environments such as delirium identification. In the "Mobility" domain, the main challenges include reduced mobility and geriatric complications, unnecessary mobility restrictions, and the increased risk of falls due to lack of resources and environmental factors. The study highlighted the need for improvements in inpatient care for older adults at an academic hospital in Korea. Identified unmet needs and barriers can be used to guide a more patient-centered approaches for an age-friendly inpatient environment.

Creating a Self-management Mobile Application for People With Chronic Low Back Pain: A Focus Group Study of Unmet Needs and Strategies.

Mobile health can fulfill the unmet needs of patients with chronic low back pain by recommending individualized management plans. Limited mobile applications have been developed based on the needs, preferences, and values relative to self-management of patients with chronic low back pain. This study aimed to explore the experience of patients with chronic low back pain and the desired content, designs, and features of a self-management application. We conducted five focus groups (N = 24). Participants provided feedback on draft contents and they also discussed the desired designs and features of an application while reviewing a low-fidelity prototype. Data were audio-recorded, transcribed verbatim, and analyzed using qualitative content analysis. Three categories and eight subcategories emerged. Participants: (1) confronted difficulties of their pain experience along with vicious cycles of pain and unmet needs; (2) acknowledged the importance of self-management as they lived with chronic low back pain and realized how to self-manage their pain; and (3) suggested ways to fulfill needs and preferences among patients with chronic low back pain. The nature of chronic low back pain causes disruptions well-being and requires constant management. Developing user-centered strategies to enhance knowledge and promote self-management among chronic low back pain patients is required.

Physician Perceptions of the Clinical, Economic and Humanistic Burden of Disease and Unmet Needs in Myelofibrosis: Preliminary Findings from the MPN Landmark Survey in Indonesia.

A cross-sectional survey was designed and administered between November and December 2021 among practicing Haematologists-Medical Oncologists who are experienced in treating patients with MF. The objectives of the survey were to assess physician's understanding of the overall diagnosis of MF, the disease burden, current treatment practices and remaining unmet needs. Outcomes were analysed descriptively. The survey was completed by 30 respondents. The findings suggest that symptom burden is high and has a significant negative impact on quality-of-life. Treatment burden is also high which can result in high healthcare resource utilisation. Physicians expressed need for novel therapeutic options and improved access and coverage for such options. There is also a need to improve access and coverage for JAK V617F testing locally and local hospital infrastructures should be upgraded to ensure MF is accurately diagnosed. Patient may benefit from information on MPN, which may result in earlier presentation, diagnosis and treatment which can improve outcomes. The findings align with previous international research reporting that symptoms and treatment burden are high, and that novel therapeutic options are needed. Additional patient research might be required to better understand the patient experience of MF and how this can be improved.

Recalcitrant Pyoderma Gangrenosum: Clinical Burden and Unmet Needs.

Pyoderma gangrenosum (PG) is a rare, autoinflammatory disease leading to aseptic ulcers which carries a significant disease burden and is often difficult to treat, with many patients failing first-line treatment and requiring additional therapies. Such cases are typically referred to in the literature as "recalcitrant", "refractory", or "resistant", though little is known about the clinical characteristics of such cases. We performed a narrative literature review to characterize patient demographics and clinical course associated with difficult to treat pyoderma gangrenosum cases in order to identify trends to guide future clinical management and therapeutic innovation. We identified 148 cases with clinical manifestations and associated patient demographics stratified by ulcer and patient features. Consistent with previous work, a greater prevalence of PG was observed among female patients and those with a history of inflammatory bowel disease, however interestingly despite an aggressive course to their PG, few patients had comorbidities complicating their disease course. Additionally, despite the requirement of three or more treatments for most patients' disease to resolve, the majority healed within the typical window observed in previous clinical studies with low rates of recurrence. Biologics were the most common medication patients were on at time of remission. Collectively, our results suggest a potential benefit for a reduced threshold for biologic initiation in PG patients and a need for standardization of language in the field to facilitate treatment outcomes comparisons and interventions.

Protocol for a Prospective Cohort Study to Evaluate Changes in Sexuality in Patients With Primary Cervical Cancer Using Patient-Reported Outcomes (JGOG9004, SARAH Study), and Our Approaches to Solving the Unmet Needs of Patients With Gynecological Cancer

Protocol for a Prospective Cohort Study to Evaluate Changes in Sexuality in Patients With Primary Cervical Cancer Using Patient-Reported Outcomes (JGOG9004, SARAH Study), and Our Approaches to Solving the Unmet Needs of Patients With Gynecological Cancer

Stroke Experiences and Unmet Needs of Individuals of African Descent Living in High-Income Economy Countries: a Qualitative Meta-Synthesis.

Stroke service disparities experienced by individuals of African descent highlight the need to optimize services. While qualitative studies have explored participants' unique experiences and service needs, a comprehensive synthesis is lacking. To address current knowledge gaps, this review aimed to synthesize existing literature on the experiences of individuals of African descent impacted by a stroke living in high-income economy countries in terms of stroke prevention, management, and care. A qualitative meta-synthesis incorporating a meta-study approach was conducted to obtain comprehensive and interpretive insights on the study topic. Four databases were searched to identify qualitative English-language studies published in the year 2022 or earlier on the experiences of adults of African descent who were at risk or impacted by a stroke and living in high-income economy countries. Study methods, theory, and data were analyzed using descriptive and interpretive analyses. Thirty-seven studies met our inclusion criteria, including 29 journal articles and 8 dissertations. Multiple authors reported recruitment as a key challenge in study conduct. Multiple existing theories and frameworks of health behaviours, beliefs, self-efficacy, race, and family structure informed research positionality, questions, and analysis across studies. Participant experiences were categorized as (1) engagement in stroke prevention activities and responses to stroke symptoms, (2) self-management and self-identity after stroke, and (3) stroke care experiences. This study synthesizes the experiences and needs of individuals of African descent impacted by stroke. Findings can help tailor stroke interventions across the stroke care continuum, as they suggest the need for intersectional and culturally humble care approaches.

Exploring the Unmet Needs of Young Adults with Stroke in Australia: Can Technology Help Meet Their Needs? A Qualitative Study.

The post-stroke needs of young adults with stroke are not being met, as most resources are tailored to older people with stroke. This includes technology-based applications, which are being used more frequently in stroke rehabilitation. There is limited data on technology usage to support the unique needs of young adults with stroke in Australia. This study aimed to explore the unmet needs of young adults aged 18-30 years with stroke and ascertain how technology can help meet those needs to improve quality of life and participation. Sixteen in-depth semi-structured interviews were conducted with young adults with stroke (n = 10), healthcare professionals (n = 3) and caregivers of young adults with stroke (n = 3). The interviews were transcribed verbatim and analyzed inductively. Five themes were generated: 'Support for recovery', 'Availability of specific resources', 'Continuity of care', 'Adjustment' and 'Knowledge'. This study revealed the unique needs of young adults under 30 years with stroke who requested more targeted post-stroke support, age-specific resources and improved awareness on young stroke, with technology playing a pivotal role in all these interventions. We suggest co-designing technology-based solutions with young people after stroke to maximize their effectiveness in improving quality of life and participation in this unique cohort.

Unmet Needs in Real-World Advanced Therapy-Naïve and -Experienced Patients with Moderately to Severely Active Ulcerative Colitis in the United States.

Despite availability of advanced therapies (ATs) for ulcerative colitis (UC), many patients fail to respond to treatment. This study examined real-world clinical and humanistic outcomes associated with current treatments in patients with UC. This cross-sectional study used US data from the Adelphi Real World Disease Specific Programme for inflammatory bowel disease from before (2017-2018) and during the COVID-19 pandemic (2020-2021). Physicians (gastroenterologists) seeing > 5 patients/month reported patients' disease characteristics, current symptoms and treatments, and reasons for treatment choices for their next seven consecutive patients aged ≥ 18years with moderately to severely active UC before current treatment. Patients were asked to complete the EQ-5D-5L health-related quality of life (HRQoL) measure. ATs included tumor necrosis factor inhibitors (TNFis), integrin receptor antagonists, interleukin-12/23 antagonists, and Janus kinase inhibitors. Patients were classified as AT-naïve or AT-experienced based on current treatment received for ≥ 8weeks and further classified as responders or non-responders based on symptoms, disease flare status, and remission. Descriptive analyses are presented. The 2017-2018 cohort included 92 physicians and 539 patients (208 [38.6%] AT-experienced). The 2020-2021 cohort included 73 physicians and 448 patients (349 [77.9%] AT-experienced). TNFis were the most common ATs. In 2017-2018, 195 (58.9%) AT-naïve and 113 (54.3%) AT-experienced patients were non-responders; in 2020-2021 this was 57 (57.6%) and 182 (52.1%). Efficacy and induction of remission were physicians' most common reasons for AT choice. Dislike of injections/infusions was the most common reason for eligible patients not receiving biologic therapy. Numerically, non-responders (both AT-naïve and AT-experienced) had more symptoms, overall pain and fatigue, and lower HRQoL scores than responders. Before (2017-2018) and during the pandemic (2020-2021), over half of patients with UC did not respond to AT. Non-responders carried a high burden of disease. Alternative therapies are urgently needed to treat UC.