Treatment Patient Satisfaction Research Articles

Health-Related Quality of Life and Treatment Satisfaction of Patients with Blood Cancer in Kazakhstan: A Cross-Sectional Study.

This was a cross-sectional study, conducted from November 2022 to December 2022, which enrolled all adult blood cancer patients registered at the healthcare facilities of Semey. This study involved 87 respondents. A questionnaire of the authors' design and the SF-36 questionnaire were used to obtain the data, which was validated. Out of 87 patients, 47 (54,0%) were males whose mean age was 35,72 ± 1,64 years and 40 (46,0%) were females with the mean age of 45,83 ± 1,57 years. None of the patients were very satisfied with their current clinical management and status monitoring and the overall rate of patient dissatisfied or somewhat dissatisfied was 48.9%. The two questions of "How long have you been seen by a hematologist?" (p=0,019) and "How do you evaluate the organization of medical care in the field of hematology?" (p=0,000) were predictors of patient satisfaction in multiple linear regression analysis. There was a significant difference in the individual SF-36 dimensions and overall QOL scored in different age group participants. Overall, the study found that the five determinates affect QOL revealed significant differences between individual age groups and identified key determinants of patient dissatisfaction. Also, it is the first attempt to understand the experience of blood cancer patients in the healthcare system in Kazakhstan, and the results may contribute to a discussion between healthcare professionals and patients on initiatives that need to be taken to improve the quality of healthcare services provided.

Nevus of Ota: Combination Treatment with Q-Switched Neodymium-Doped Yttrium Aluminum Garnet Laser and Fractional CO2 Laser.

Nevus of Ota is a facial dermal melanocytic hamartoma occurring more commonly in Asians. The mainstay of treatment is 1064-nm Q-Switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, which has shown variable results in pigmented skin. The aim of this study was to determine whether Q-Switched Nd:YAG laser treatment combined with fractional CO2 laser is more efficacious than Q-Switched Nd:YAG laser alone. This was a prospective study with 81 patients. The patients were randomly divided into two groups. Group 1 received 1064-nm Q-Switched Nd:YAG laser alone and group 2 in addition received a fractional CO2 laser as well. Both groups received six sittings at monthly intervals. The treatment response was documented with physician global assessment (PGA) and patient's treatment satisfaction on Wong-Baker Facial Pain Scale (WBFPS). Dermoscopic evaluation was done to see subsurface pigment clearance. In the combination group, 25% of patients had more than 50% improvement as compared with 5.71% in group 1. To achieve a mean PGA score of 1.4, it took six sessions for group 1 versus only four for group 2. Dermoscopic evaluation showed faster pigment clearance in the combination group. Combining two lasers shows statistically significant faster and greater degree of improvement as compared with Q-Switched Nd:YAG laser monotherapy in nevus of Ota.

The PCQ-Infertility Revised: A New Digital Instrument to Measure Treatment Satisfaction of Fertility Patients.

One of the key dimensions of healthcare quality is patient-centeredness, which represents how well healthcare is geared towards patients' needs and wishes. Many questionnaires that measure the patient-centeredness are long and complicated, eliciting non-response or careless responding. Moreover, responses to some commonly used questionnaires are difficult to interpret. The Patient-Centeredness Questionnaire-Infertility (PCQ-Infertility) is used to measure the patient's experience of fertility healthcare quality. The aim of this study was to improve the PCQ-Infertility to allow large-scale clinical implementation. The study was performed in three parts. First, shortcomings of the original PCQ-Infertility were identified by evaluation of expert opinions. Second, the number of items were reduced, and items were rescaled and rephrased. Third, 844 patients filled in the original PCQ-Infertility and 260 patients filled in the revised PCQ-Infertility and reliability analyses were performed. In addition, a confirmatory factor analysis was performed on the revised PCQ-Infertility. The number of items in the revised questionnaire was reduced by 24% (from 51 to 39 items), which increased the internal consistency and reliability. The reliability analyses and confirmatory factor analysis indicated high consistency and convergent validity in all seven dimensions (accessibility, information, communication, patient involvement, respect for patient's values, continuity and transition, and competence) of the revised PCQ-Infertility. The revised PCQ-Infertility is a more valid and reliable instrument than the original PCQ-Infertility, easier to interpret and shorter. Therefore, large-scale clinical implementation and data analysis are now possible, giving the opportunity for fertility care professionals to evaluate and improve their healthcare.

403 Achievement of minimal disease activity is associated with improvements in symptoms, quality of life and treatment satisfaction in patients with atopic dermatitis

Abstract There is a need for clear criteria to guide treatment decisions and disease management in patients with atopic dermatitis (AD). The recently developed minimal disease activity (MDA) concept aims to optimize AD management through shared decision-making between patients and clinicians in a treat-to-target approach, and is based on consensus recommendations from 87 physicians and insights from 88 patients globally.This study aims to evaluate how achieving MDA affects outcomes in patients with AD. Observed-case data from three phase 3 clinical trials involving adolescents and adults with moderate-to-severe AD were integrated and analysed (NCT03568318, NCT03569293 and NCT03607422). The MDA criteria were applied to clinician-reported measures [Eczema Area and Severity Index (EASI), SCORing of Atopic Dermatitis, validated Investigator Global Assessment, and body surface area] and patient-reported measures [Worst Pruritus Numerical Rating Scale (WP-NRS), Patient-Oriented Eczema Measure, Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain score, Atopic Dermatitis Impact Scale (ADerm-IS) Sleep disturbance score, Hospital Anxiety and Depression Scale and Dermatology Life Quality Index]. Patients were stratified into three mutually exclusive groups by achievement of treatment targets per measurement at week 16: (i) achieving the optimal target (i.e. MDA) criteria [e.g. EASI improvement ≥90% (EASI 90); WP-NRS ≤1], (ii) achieving the moderate but not optimal target criteria [e.g. EASI improvement ≥75% and <90%; WP-NRS improvement (reduction) ≥4 and WP-NRS >1] and (iii) not achieving either target criteria. Among the stratified target groups (optimal, moderate and neither), patients’ symptoms, quality of life, work productivity and treatment satisfaction were assessed based on achieving meaningful clinically important differences in ADerm-SS 7-item total symptom score (ADerm-SS TSS-7; improvement ≥28), ADerm-IS Daily Activities score (improvement ≥14), ADerm-IS Emotional State score (improvement ≥11), percentage-point improvement in Work Productivity and Activity Impairment (WPAI) Overall Work Productivity score and proportion reporting Patient Global Impressions of Treatment of ‘Extremely/Very Satisfied’. Stratified target groups were compared with a chi-squared or t-test for categorical or continuous variables, respectively, based on observed data. This analysis included 2392 patients. Patients in the optimal target (MDA) group based on EASI (EASI 90) vs. those in the moderate or neither target group had a higher proportion reporting meaningful improvements in ADerm-SS TSS-7 (optimal = 82.6% vs. moderate = 56.8% or neither = 27.4%; P < 0.001 for both comparisons), ADerm-IS Daily Activities (87.2% vs. 66.2% or 39.9%; both P < 0.001) and ADerm-IS Emotional State (86.1% vs. 67.1% or 36.8%; both P < 0.001); a greater percentage-point improvement in WPAI Overall Work Productivity (36.8% vs. 29.2% or 16.6%; both P < 0.01); and a higher proportion reporting being very/extremely satisfied with treatment (73.5% vs. 54.0% or 23.5%; both P < 0.001). Patients in the optimal target (MDA) group based on itch (WP-NRS ≤1) vs. those in the moderate or neither target group had a higher proportion reporting meaningful improvements in ADerm-SS TSS-7 (94.3% vs. 79.7% or 19.1%; both P < 0.001), ADerm-IS Daily Activities (97.3% vs. 84.7% or 33.6%; both P < 0.001) and ADerm-IS Emotional State (94.5% vs. 84.5% or 31.7%; both P < 0.001); a greater percentage-point improvement in WPAI Overall Work Productivity [39.7% vs. 35.2% (not significant) or 14.6% (P < 0.001)]; and a higher proportion reporting being very/extremely satisfied with treatment (79.7% vs. 60.5% or 26.8%; both P < 0.001). Trends were similar in other clinician- and patient-reported measures, with patients who achieved MDA generally reporting better outcomes. Achieving MDA from both a clinician and patient perspective was generally associated with greater improvements in AD symptoms, daily activities, emotional state, work productivity and higher satisfaction. These results demonstrate the value of achieving MDA and support implementing MDA in clinical practice to help improve the current standard of AD care.

#3156 REAL WORLD CHARACTERISTICS, SYMPTOM BURDEN AND TREATMENT PATTERNS OF ANAEMIA OF CKD IN EGYPT, SAUDI ARABIA, SOUTH AFRICA, AND TURKEY

Abstract Background and aims Patients with chronic kidney disease (CKD) often have comorbid anaemia [1]. Real-world data on patient characteristics, disease burden, and treatment management for people with anaemia of CKD in the Middle East and Africa are limited. Methods SATISFY (Survey on treatment patterns in Anemia of CKD, patient Treatment satISFaction and perspectives as reported by patients with phYsicians) was a real-world survey conducted between 01 June to 01 September 2022 in Egypt, Saudi Arabia, South Africa, and Turkey. Physician and patient perceptions of treatment were captured via cross-sectional surveys; patients’ clinical characteristics were recorded by physicians in electronic case report forms via retrospective review of medical records. Eligible physicians were nephrologists with ≥1 years’ experience who managed ≥12 patients with anaemia of CKD per month and with drug management experience for anaemia of CKD. Physicians collected data on the first 7–10 patients seen in routine clinical practice during the study period. Eligible patients were ≥18 years with CKD stage 3b, 4, or 5 at the time of anaemia of CKD diagnosis and with ≥2 years’ follow-up data from diagnosis to time of survey. Patients with functioning kidney transplants or acute kidney injury were excluded. Primary outcomes were to describe clinical and demographic characteristics, monitoring test results, treatment patterns of patients with anaemia of CKD, physicians’ reasons for not treating anaemia of CKD, and physicians’ and patients’ reasons for therapy choice. Data were analysed descriptively. Results A total of 1788 patients and 217 physicians were included; 1138 patients (64%) were non-dialysis dependent (NDD) and 611 (34%) were dialysis dependent (DD) at the time of data extraction (n = 39 [2%] data missing). Mean (standard deviation [SD]) age was 46 (14) years, mean (SD) body mass index was 24.1 (3.1) kg/m2, 56% (n = 1004) were male, and median (interquartile range [IQR]) follow-up from diagnosis of anaemia of CKD was 2.6 (2.5–3.2) years. The most common comorbidities were hypertension (n = 858, 48%) and diabetes (n = 324, 18%). Symptom burden was high, with lack of energy and fatigue being among the most commonly reported symptoms by physicians and patients across both NDD and DD groups (Figure 1). Differences were seen between physician and patient symptom reporting and between NDD and DD groups. Patients’ self-reported symptom burden was greater than that reported by physicians, particularly for NDD patients. The median (IQR) times per year physicians reported testing CKD patients for anaemia was 4 (4–6) for NDD patients and 12 (10–12) for DD patients. Median test levels for haemoglobin at which patients were diagnosed were lower than those reported by physicians as being used for diagnosis; similar results were seen for thresholds used to initiate treatment (Table 1). Median (IQR) days from diagnosis to first treatment was 61 (0–419). Of those who received treatment, the most common first treatment option was erythropoietin-stimulating agents + intravenous iron for both patients with NDD and DD anaemia of CKD at diagnosis (NDD n = 291/736, 40%; DD n = 170/316, 54%). A large proportion of patients never received treatment for anaemia of CKD (n = 701, 39%). The most important reasons to not initiate treatment from a physician perspective were patient refusal (n = 172, 79%) and risk of adverse reactions (n = 168, 77%); for patients, top reasons were that their symptoms were not severe (n = 168, 22%) and their physicians’ concerns about adherence (n = 116, 15%). Similar reasons were seen for both the Middle East and Africa regions. Conclusion Symptom burden is high in patients with anaemia of CKD in the Middle East and Africa, particularly lack of energy and fatigue. Differences were seen between physician and patient perceptions of symptom burden and between NDD and DD groups. Substantial treatment inertia exists. Physicians rated patient refusal and risk of adverse reactions as main reasons for not treating patients, while patients attributed this to a belief that their symptoms were not severe.

#5424 SYMPTOM CONTROL WITH CURRENTLY AVAILABLE IMMUNOGLOBULIN A NEPHROPATHY TREATMENT: RESULTS FROM A REAL-WORLD SURVEY IN EIGHT COUNTRIES

Abstract Background and Aims Immunoglobulin A nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis worldwide with an estimated annual incidence of 25 cases per million people. Many patients are not diagnosed until they develop kidney dysfunction, such as hematuria and proteinuria. Proteinuria >1g/day is associated with a high risk of progression. The aim of the present study is to describe symptom control and consider treatment satisfaction for patients undergoing treatment for IgAN. Method Data were drawn from the Adelphi IgAN Disease Specific Programme (DSP)™, a point-in-time survey of IgAN-treating nephrologists and their consulting patients conducted in the United States (US), Europe (EU5: France, Germany, Italy, Spain, United Kingdom [UK]), Japan, and China, from June to October 2021. Nephrologists completed structured online patient record forms for successive patients presenting with IgAN including demographics, clinical characteristics and treatment patterns. Patients voluntarily completed questionnaires that corresponded with the nephrologist records, with questions about their IgAN on that day regarding symptoms experienced, disease severity, and treatment satisfaction. Patients who were receiving IgAN treatment at the time of survey are included in the presented analysis. Results The mean (standard deviation [SD]) age of patients (n = 869) was 42 (13.7) years and 57% were male. IgAN symptoms were deemed severe by 10% of patients at the time of survey and 14% before the initiation of their current treatment. Overall, 91% of patients reported having symptoms of IgAN at the time of survey, the most common were: foamy urine, feeling tired or lack of energy, and swelling, with many patients in China reporting hematuria. The top reported most bothersome symptoms were fatigue, swelling, and high blood pressure, with many patients in China also reporting proteinuria. Satisfaction with their current treatment was reported by patients; 61% reported that they were satisfied, 27% said they were neither satisfied or dissatisfied, and 12% said they were dissatisfied with their medication. This dissatisfaction was due to their current medication not working quickly enough (54%, n = 103) or that it had not helped with their IgAN symptoms (45%, n = 103). This was consistent with the physician-reported data; where proteinuria was reported across treatment lines (L), levels remained high amongst patients (mean (SD) proteinuria [g/day] at L1: 2.2 (2.3), n = 629; L2: 1.8 (2.0), n = 257; L3: 1.9 (1.4), n = 95) and estimated glomerular filtration rate (eGFR) continued to fall (mean (SD) eGFR [mL/min/1.73m2] at L1: 77.1 (29.6), n = 615; L2: 72.2 (30.3), n = 246; L3: 66.9 (31.1), n = 96). Conclusion Despite treatment, most patients with IgAN continued to experience symptoms. Many of these symptoms were considered bothersome by patients, including fatigue, swelling and high blood pressure which may have an impact on their everyday lives. These data highlight an unmet need for effective IgAN management and future treatments should aim to target better symptom relief and disease progression.

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice.

Tildrakizumab (TIL) is an interleukin (IL)-23p19 inhibitor for the treatment of moderate-to-severe plaque psoriasis with long-term efficacy and safety demonstrated in Phase III trials. Studies conducted in conditions closer to clinical practice are needed. The TRIBUTE study (open-label, Phase IV) assessed the efficacy and impact on health-related quality of life (HRQoL) of TIL 100 mg in adult moderate-to-severe psoriasis patients (naïve to IL-23/Th17 pathway inhibitors) in conditions similar to clinical practice. Key efficacy measure was Psoriasis Area Severity Index (PASI). HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) and Skindex-16. Additional patient-reported outcomes included Pain-, Pruritus- and Scaling-Numerical Rating Scale (NRS), Medical Outcome Study (MOS)-Sleep, Work Productivity and Activity Impairment (WPAI), Patient Benefit Index (PBI) and Treatment Satisfaction Questionnaire for Medication (TSQM). One hundred and seventy-seven patients were enrolled (six patients did not complete the study). After 24 weeks, the proportion of patients achieving PASI scores ≤ 3, PASI 75, PASI 90 and DLQI 0/1 was 88.4%, 92.5%, 74.0% and 70.4%, respectively. Skindex-16 overall score improved (mean absolute change from baseline, MACB [95%CI]: -53.3 [-58.1, -48.5]). Significant benefits (MACB [95%CI]) were found on pruritus-, pain- and scaling-NRS scores (-5.7 [-6.1, -5.2], -3.5 [-4.1, -3.0] and -5.7 [-6.2, -5.2], respectively), MOS-Sleep (-10.4 [-13.3, -7.4] Sleep problems Index II) and WPAI (-36.4 [-42.6, -30.2] activity impairment, -28.2 [-34.7, -21.7] productivity loss, -27.0 [-32.9, -21.1] presenteeism and -6.8 [-12.1, -1.5] absenteeism). 82.7% of patients reported PBI ≥ 3 and the mean (SD) global TSQM score was high (80.5 [18.5]). Only one serious treatment-emergent adverse event was reported (not-related to TIL). TIL 100 mg treatment after 24 weeks in conditions close to real clinical practice showed a quick and high improvement in psoriasis signs and HRQoL. Patient reported improvements in sleep outcomes and work productivity, relevant benefits and high treatment satisfaction. The safety profile was favourable and consistent with Phase III trials.

Open label single arm study to assess the implementation of home based daratumumab administration in patients being treated for multiple myeloma.

TPS1609 Background: Multiple myeloma (MM) is an incurable hematologic malignancy that has a high burden of care for patients and their caregivers. Over the last two decades, the treatment landscape for MM has changed dramatically. However, treatment burden with frequent visits to offices and the hospital is high. We need innovative care delivery models to alleviate these burdens. Chemotherapy at home remains uncommon in the US, though models for its use exist globally. In these models, home-based chemotherapy is safe, preferred by patients, and can be administered at lower cost. Herein, we propose a home-based subcutaneous daratumumab and hyaluronidase-fihj (dara) program for patients with MM. We hypothesize that this program will be feasible, reduce patient treatment and financial burden, and improve quality of life. Methods: We designed an open label single arm study to assess the implementation of home administration of dara. The primary objective is to evaluate (n=20) treatment satisfaction of patients, using the Cancer Therapy Satisfaction Questionnaire (CTSQ), when they receive care at home as compared to the standard of care (SOC). Secondary outcomes include evaluating adherence to home delivery, quality of life (EORTC QLQ-30), financial burden (COST survey), safety of home administration, and barriers to home administration. At the end of the study, we will conduct semi-structured interviews to assess patient experience with home administration of chemotherapy. Patients will be eligible for study participation if they have a diagnosis of multiple myeloma, are in the monthly phase of dara treatment and are treated with either monotherapy or in combination with oral agents. All participants who are interested and eligible will be on study for 8 cycles of dara (2 cycles of dara in the infusion center (IC) followed by 4 cycles at home and then 2 cycles in the IC). During the home administration phase, 1-3 days prior, patients will go to a local lab or have at home labs. On day of at home dara, the drug will be mixed and packaged by our pharmacy, and then delivered at room temperature to the patient’s home by our home infusion courier. The patient will take pre-medications 1-3 hours prior to nurse arrival. The nurse arrives, confirm pre-medications were taken. Pre-treatment vitals and post treatment vitals will be obtained. Drug will be administered as per label instructions. At the beginning of each cycle, patient reported outcome surveys and quality of life surveys will be collected. During the home administration phase, details on barriers to maintaining adherence (i.e. issues with storage, delivery, disposal of medication) will be collected. The study opened for enrollment on November 8th, 2022. As of February 1stth 2023, 9 patients have consented and 5 patients are on-treatment. Clinical trial information: NCT05511428 .

Safety and efficacy of autologous skin tissue cells grafting for facial sunken or flat scars

ImportanceIt is necessary to determine whether safety and efficacy of autologous skin tissue cells grafting for facial sunken or flat scars. ObjectiveTo identify autologous skin tissue cells grafting can reduce facial sunken or flat scars. Design, setting, and participantsIn this retrospective cross-sectional study, a total of 128 patients with scar (exclude pathological scar patients), who were receiving autologous skin tissue cells grafting therapy from January 1, 2016, to December 31, 2019. InterventionsAutologous skin tissue cells grafting. Main outcomes and measuresChanges in scar severity, color changes in the scar area, infection rate and patient satisfaction. ResultsA total of 128 patients with scar (89 females [69.5%]; mean [SD] age, 30.6 [13.12] years) received autologous skin tissue cells grafting therapy. SCAR (Scar Cosmesis Assessment and Rating), with scores ranging from 0 (best possible scar) to 15 (worst possible scar). After treatment 12 months, the mean [SD] of SCAR score went down from 9.85 [1.33] to 2.67 [1.21]. No infection was observed during treatment or recovery, and the main drawback after autologous skin tissue cells grafting is that the color recovery time is longer. The patient satisfaction 6 months after treatment was 85.2%, furthermore 12 months after treatment patient satisfaction was 94.7%. Conclusions and relevanceIn this study, autologous skin tissue cells grafting was safe and effective to treat facial scars. Therefore, autologous skin tissue cells grafting may be recommended as a reliable treatment for facial scar.

Open source automated insulin delivery systems: benefits, limitations and challenges in diabetes care

Open source closed loop automated insulin delivery (CL-AID) systems are increasingly used in the treatment of diabetes. Assembled on a do-it-yourself (DIY) basis, these systems integrate insulin pumps, continuous glucose monitoring devices, and algorithms that control the rate of insulin delivery based on glucose levels. In this review, we consider the technological features of open source CL-AID systems (OpenAPS, AndroidAPS, Loop, etc.), advantages and barriers to their use in clinical practice. Advantages of open source CL-AID systems over commercially available ones included lower cost, a choice of devices, a wide range of user settings, as well as continuous improvement of algorithms. A growing body of evidence indicates that open source CL-AID systems, such as OpenAPS, AndroidAPS, and Loop, provide an excellent time in range with minimal risk of hypoglycaemia and increase treatment satisfaction in patients with type 1 diabetes. A wide range of settings makes open source systems an effective tool for managing diabetes in situations with rapidly changing insulin requirement. However, some technological, medical, legal and ethical issues associated with the use of non-commercial CL-AID systems still need to be addressed. Assembling the system requires skills in diabetes technology. The issue of cybersecurity is also relevant. Lack of official approvals, low awareness of medical professionals, and reimbursement issues are slowing down the introduction of the technology into clinical practice. The professional medical community at the international and national levels needs to determine its position regarding the use of open source CL-AID systems in the treatment of diabetes.

Head-To-Head Comparison of Vortioxetine Versus Desvenlafaxine in Patients With Major Depressive Disorder With Partial Response to SSRI Therapy: Results of the VIVRE Study.

Objective: To compare the efficacy of vortioxetine and the serotonin-norepinephrine reuptake inhibitor (SNRI) desvenlafaxine in patients with major depressive disorder (MDD) experiencing partial response to initial treatment with a selective serotonin reuptake inhibitor (SSRI).Methods: This randomized, double-blind, active-controlled, parallel-group, 8-week study of vortioxetine (10 or 20 mg/d; n = 309) versus desvenlafaxine (50 mg/d: n = 293) was conducted from June 2020 to February 2022 in adults with a DSM-5 diagnosis of MDD who experienced partial response to SSRI monotherapy. The primary endpoint was mean change from baseline to week 8 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Differences between groups were analyzed using mixed models for repeated measures.Results: Non-inferiority of vortioxetine versus desvenlafaxine was established in terms of mean change from baseline to week 8 in MADRS total score; however, a numeric advantage was observed in favor of vortioxetine (difference, -0.47 MADRS points [95% CI, -1.61 to 0.67]; P = .420). At week 8, significantly more vortioxetine-treated than desvenlafaxine-treated patients had achieved symptomatic and functional remission (ie, Clinical Global Impressions-Severity of Illness scale [CGI-S] score ≤ 2) (32.5% vs 24.8%, respectively; odds ratio = 1.48 [95% CI, 1.03 to 2.15]; P = .034). Vortioxetine-treated patients also experienced significantly greater improvements in daily and social functioning assessed by the Functioning Assessment Short Test (P = .009 and .045 vs desvenlafaxine, respectively) and reported significantly greater satisfaction with their medication assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire (P = .044). Treatment-emergent adverse events (TEAEs) were reported in 46.1% and 39.6% of patients in the vortioxetine and desvenlafaxine groups, respectively; these were mostly mild or moderate in intensity (> 98% of all TEAEs in each group).Conclusions: Compared with the SNRI desvenlafaxine, vortioxetine was associated with significantly higher rates of CGI-S remission, better daily and social functioning, and greater treatment satisfaction in patients with MDD and partial response to SSRIs. These findings support the use of vortioxetine before SNRIs in the treatment algorithm in patients with MDD.Trial Registration: ClinicalTrials.gov Identifier: NCT04448431.

Patient-Physician Communication and Perception of Treatment Goals in Rheumatoid Arthritis: An Online Survey of Patients and Physicians.

To evaluate patient-physician communication and patients' understanding of treatment goals in rheumatoid arthritis (RA). A cross-sectional online survey of patients with RA and physicians treating RA was conducted between 16 and 30 June 2021. Participants were asked to rate the importance of 17 goals on a 6-point Likert scale, and mean scores were compared between patients and physicians by the Wilcoxon rank sum test. Patients' satisfaction with physician communication and their understanding of treatment goals were also assessed. The responses of 502 patients and 216 physicians were analyzed. The most common patient age group was 50-59years (28.5%), and the mean disease duration was 10.3years. Physicians had a mean of 19.2years of treatment experience and were treating a mean of 44.3 patients. Among the 17 goals assessed, patients placed significantly more importance on drug tapering or discontinuation as short-term goals (3-6months) and on performing basic activities of daily living, being able to engage in daily tasks, achieving and maintaining remission, maintaining better laboratory values, and drug tapering or discontinuation as long-term goals (5-10years; all adjusted p < 0.05). Patient treatment satisfaction was significantly associated with disease activity, a feeling of treatment effectiveness, satisfaction with physician communication, and agreement with physician goals. Differences exist among patients with RA and physicians treating RA regarding the importance of short- and long-term treatment goals. Good patient-physician communication appears to be important for improving patient satisfaction. University Hospital Medical Information Network identifier: UMIN000044463.

Analysis of diabetes attitudes, wishes and needs in Switzerland, the Swiss DAWN2™ Study

Swiss DAWN2™ aimed to evaluate the difficulties and unmet needs of individuals with diabetes and stakeholders, based on the assessments of diabetes care and self-management: the individual burden of disease, the perception of the quality of medical care, and the treatment satisfaction of individuals with diabetes living in the Canton of Bern. The results of the Swiss cohort were analysed and compared with the global DAWN2™ results. 239 adult individuals with diabetes were enrolled in a cross-sectional study at the Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism at the University Hospital of Bern between 2015 and 2017. The participants completed validated online questionnaires regarding health-related quality of life (EQ-5D-3L) and emotional distress (PAID-5), diabetes self-care activities (SDSCA-6), treatment satisfaction (PACIC-DSF), and health-related wellbeing (WHO-5). Eligibility criteria were as follows: participants were aged >18 years, had a diagnosis of diabetes type 1 or 2 since at least 12 months and gave written informed for the participation in the present study. When compared globally, the Swiss cohort reported a higher quality of life (77.28 ± 16.73 vs. 69.3 ± 17.9 EQ-5D-3L score, p <0.001) and lower emotional distress (22.28 ± 20.94 vs. 35.2 ± 24.2 PAID-5 score, p = 0.027). Higher frequencies of self-measurement of blood glucose (6.43 ± 1.68 vs. 3.4 ± 2.8 SDSCA-6 score, p <0.001) and physical activity (4.40 ± 2.04 vs. 3.8 ± 2.7 SDSCA-6 score, p = 0.05) were reported. PACIC-DSF revealed higher satisfaction concerning organisational aspects of patient care (60.3 ± 1.51 vs. 47.3 ± 24.3, p<0.001) and higher health-related well-being as compared to the global score (71.38 ± 23.31 vs. 58 ± 13.8 WHO-5 Well-Being Index, p <0.001). HbA1c >7% correlated to emotional distress (PAID-5, 26.08 ± 23.37 vs. 18.80 ± 17.49, p = 0.024), unfavourable eating habits (4.28 ± 2.22 vs. 4.99 ± 2.15, p = 0.034) and decreased physical activity (3.95 ± 2.16 vs. 4.72 ± 1.92, p = 0.014). Sleeping problems were most commonly reported (35.6%). In total, 28.8% of respondents completed diabetes-related educational programs. In global comparison, Swiss DAWN2™ showed a lower burden of disease and yet a higher level of treatment satisfaction in patients who were treated in Switzerland. Further studies are required to assess the quality of diabetes treatment and unmet needs in patients treated outside of a tertiary care center.

Commentary: Determinants of quality of life and treatment satisfaction in dual-diagnosis patients.

Commentary: Determinants of quality of life and treatment satisfaction in dual-diagnosis patients.

The association between social determinants of health and patient-centred outcomes in adults with heart failure with reduced ejection fraction.

To explore the associations between social determinants of health and patient-centred outcomes among adults with chronic heart failure with reduced ejection fraction. Cross-sectional online self-report survey. A survey assessing social determinants of health (demographics, socio-economic position, affordability of care and social support) and patient-centred outcomes, including the Kansas City Cardiomyopathy Questionnaire-12 and validated measures of medication adherence, treatment satisfaction, treatment burden and mental health, was completed by 512 adults with chronic heart failure with a reduced ejection fraction between 06 March and 29 June 2020. Multivariable analyses included linear and logistic regression. Female gender, having a care partner, and being offered financial assistance with medications were associated with worse health status, while perceiving medication as affordable and being married were associated with better health status. Females and having Medicaid, dual Medicaid/Medicare or no medical insurance were associated with a higher likelihood of depression, and non-white race/ethnicity was associated with less depression. Medication adherence was lower in patients having a care partner and offered financial assistance. Patients being offered financial and medication management assistance were more likely to be overwhelmed by the treatment burden, whereas those having some college education were less so. Social determinants of health are associated with patients' disease-specific health status, mental health and treatment satisfaction and burden. These findings underscore the importance of assessing social determinants of health in clinical practice and the need for developing and testing novel strategies to determine whether they improve patients' health. The relationship between social determinants of health- and patient-centred outcomes was assessed; affordability of care and social support factors were most strongly associated with outcomes for patients with chronic heart failure and reduced ejection fraction, underscoring the importance of assessing social determinants of health in routine clinical care. Social determinants of health data could potentially inform care delivery for patients with heart failure and reduced ejection fraction by helping to identify those who require additional support to manage their symptoms, access care and adhere to treatment. Social support and affordability of treatment were associated with most patient-centred outcomes, suggesting these factors may provide clinicians with an indicator of a patient's level of general well-being that could be assessed during routine follow-up care. This research followed the STROBE checklist for cross-sectional studies. Adults who have heart failure with reduced ejection fraction that consented to participate in the study provided the data used for all analyses reported on in the manuscript. Service users, caregivers or members of the public had no involvement in the study.

Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab

BackgroundAs significant advances in the field of treatment for rheumatoid arthritis (RA), there is a great need to identify the healthcare outcomes such as treatment satisfaction and health-related quality of life (HRQoL) of patients with various treatment options. This study aims to identify the difference in the treatment satisfaction and HRQoL of patients with RA using different treatment options, by comparing the treatment satisfaction and HRQoL in patients with RA treated with tofacitinib and adalimumab in real-world settings in Korea, using propensity score methods.MethodsIn this non-interventional, multicenter, cross-sectional study (NCT03703817), a total of 410 patients with RA diagnosis were recruited in 21 university-based hospitals throughout Korea. The treatment satisfaction and HRQoL were assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) and EQ-5D questionnaires self-reported by the patients. This study compared outcomes between two drug groups in unweighted, greedy matching, and stabilized inverse probability of treatment weight (IPTW) samples using propensity score.ResultsIn all three samples, tofacitinib group showed higher convenience domain of TSQM than that in the adalimumab group, but not effectiveness, side effects, and global satisfaction domains. Multivariable analysis using the covariates of demographic and clinical characteristics of the participants also showed consistent results in TSQM. No statistical difference in EQ-5D-based HRQoL was identified between two drug groups in all three samples.ConclusionsThis study identified that tofacitinib shows higher treatment satisfaction in the convenience domain of TSQM rather than adalimumab, suggesting that various factors such as drug formulation, route or frequency of administration, and storage can have an impact on the treatment satisfaction, especially the convenience domain. These findings may be useful to patients and physicians when determining treatment options.Trial registrationClinicalTrials.gov, NCT03703817.

Does higher quality of care in systemic lupus erythematosus translate to better patient outcomes?

To assess if high quality of care (QOC) in SLE results in improved outcomes of quality of life (QOL) and non-routine health care utilization (HCU). One hundred and forty consecutive SLE patients were recruited from the Rheumatology clinic at an academic center. Data on QOC and QOL were collected along with demographics, socio-economic, and disease characteristics at baseline. LupusPRO assessing health-related (HR) QOL and non (N)HRQOL was utilized. Follow up QOL and HCU were collected prospectively at 6months. High QOC was defined as those meeting ≥80% of the eligible quality indicators. Univariate and multivariate regression analyses were performed with QOC and high QOC as independent variables and HRQOL and NHRQOL as dependent variables at baseline and follow up. Multivariable models were adjusted for demographics and disease characteristics. Secondary outcomes included non-routine HCU and disease activity at follow up. Baseline and follow up data on 140 and 94 patients, respectively, were analyzed. Mean (SD) performance rate (QOC) was 78.6 (13.4) with 52% patients in the high QOC group. QOC was associated with better NHRQOL at baseline and follow up but not with HRQOL. Of all the NHRQOL domains, QOC was positively associated with treatment satisfaction. QOC or high QOC were not associated with non-routine HCU and were instead associated with higher disease activity at follow up. Higher QOC predicted better NHRQOL by directly impacting treatment satisfaction in SLE patients in this cohort. Higher QOC, however, was not associated with HRQOL, HCU, or improvement in disease activity at follow up.

Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder

BackgroundOveractive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence.MethodsThis is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence.DiscussionOAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting.Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.

Burden of adult atopic dermatitis and unmet needs with existing therapies

ObjectivePatients with atopic dermatitis (AD) have low treatment satisfaction. In this study, we evaluated the humanistic burden, treatment satisfaction, and treatment expectations in patients with AD in the United States.MethodsAdults with AD recruited through the National Eczema Association and clinical sites completed a web-based survey comprising the Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD), Dermatology Life Quality Index; Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis; Treatment Satisfaction Questionnaire for Medication (TSQM); and answered questions on healthcare provider (HCP) visits, treatment history, and treatment goals. Descriptive analyses were performed to compare participants by severity.ResultsAmong 186 participants (mean [standard deviation] age 39.7 [15.3] years, 79.6% female), 26.9%, 44.6%, and 26.3% of the participants had mild, moderate, or severe AD, respectively, based on PO-SCORAD. Greater disease severity was associated with a greater impact on work and daily life, decreased TSQM scores, and increased HCP visits. Corticosteroid topical cream or ointment (53.8%) and oral antihistamines (31.2%) were most commonly used for the treatment of AD. Participants reported declining/stopping/changing AD treatment due to the potential for side effects or lack of efficacy. ‘Leading normal lives’ (28.0%) and ‘being itch-free’ (33.9%) were important treatment goals.ConclusionsIndividuals with AD, especially severe disease, face a considerable humanistic burden even while using treatment.

Treatment satisfaction of patients with psoriasis with topical therapy in a real-world setting: unmet need for higher effectiveness

BackgroundTopical medication is the mainstay for treatment of mild psoriasis. However, dissatisfaction with topicals is common and rates of non-adherence are high. Assessing patients’ perspectives can help to identify unmet needs.ObjectiveOur aim was to investigate satisfaction of patients with psoriasis with topical therapy and to determine influencing factors.MethodsPatients were recruited from the Department of Dermatology, University Medical Center Mannheim, Germany. Satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication version 1.4 with the domains effectiveness, side effects, convenience, and global satisfaction (scale 0–100 each). The impact of sociodemographic and disease characteristics was determined by multivariate regression.ResultsAveraged across the cohort (n = 122, mean age 52.5 years, 58.2% male), the side effects domain had the highest mean satisfaction score (89.7), followed by convenience (72.5), global satisfaction (60.8), and effectiveness (55.0). Comparing specific medications, combinations of corticosteroids and vitamin D analogues were rated best in effectiveness. Treatment satisfaction was influenced by age, partnership, ability to apply topicals independently, disease-related quality-of-life impairment, sole or adjunctive use of topicals and pruritus.ConclusionsParticipants were particularly satisfied with safety but rather dissatisfied with effectiveness of topicals. Topical therapy should be adapted to individual needs with special attention to effectiveness.