Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies - impact of drug packaging and administration method on patient reported outcomes.

BACKGROUND: Here, the perspective of patients with primary and secondary immunodeficiency receiving subcutaneous immunoglobulin (SCIg) via introductory smaller size pre-filled syringes (PFS) or vials were compared. METHODS: An online survey was conducted in Canada by the Association des Patients Immunodéficients du Québec (APIQ) (10/2020-03/2021). Survey questions included: reasons for choosing SCIg packaging and administration methods, training experiences, infusion characteristics, and switching methods. The survey captured structured patient-reported outcomes: treatment satisfaction and its sub-domains, symptom state, general health perception, and physical and mental function. Respondents using PFS were compared with vial users, overall and stratified by their administration method (pump or manual push). RESULTS: Of the 132 total respondents, 66 respondents used vials, with 38 using a pump and 28 using manual push. PFS (5 and 10 mL sizes) were being used by 120 respondents, with 38 using a pump and 82 using manual push. PFS users were associated with a 17% lower median (interquartile range) SCIg dose (10 [8, 12] vs. 12 [9, 16] g/week, respectively), a significantly shorter infusion preparation time (15 [10, 20] vs. 15 [10, 30] mins, respectively), and a trend for shorter length of infusion (60 [35, 90] vs. 70 [48, 90] mins, respectively) compared with those on vials. Patient-reported treatment satisfaction scores were overall similar between vial and PFS users (including on the domains of effectiveness and convenience), except for a higher score for vials over PFS on the domain of global satisfaction (p=0.02). CONCLUSIONS: Consistent with prescribing that reflects a recognition of less wastage, PFS users were associated with a significantly lower SCIg dose compared with vial users. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction with treatment among vial users compared with PFS users was consistent with users being limited to smaller PFS size options in Canada during the study period. Patient experience on PFS is expected to improve with the introduction of larger PFS sizes. Overall, treatment satisfaction for SCIg remains consistently high with the introduction of PFS packaging compared with vials.

Subcutaneous immunoglobulin in primary immunodeficiency - impact of training and infusion characteristics on patient-reported outcomes.

BACKGROUND: Subcutaneous immunoglobulin (SCIG) is increasingly utilized in primary immunodeficiency (PI). Understanding factors associated with treatment experience and satisfaction can optimize patient outcomes. We analyzed Immune Deficiency Foundation (IDF) survey data to evaluate patient-reported outcomes (PROs) in relation to SCIG training and infusion characteristics. Respondents' PRO scores were rank ordered into 'best', 'intermediate', and 'worst' tertiles. Predicted probabilities of being in the best tertile with any combination of characteristics were generated for each PRO. RESULTS: In 366 SCIG respondents, higher odds of being in the best PRO tertile were driven by favorable training characteristics (particularly, higher confidence post-training and no training barriers) and efficient infusions (infusion preparation ≤20 min and actual infusion < 2 h). Age (≤17 years old) and treatment experience (> 2 years) increased the odds of being in the best tertiles. Compared with the least favorable training/infusion characteristics, those with the most favorable training/infusion characteristics had higher predicted probabilities of being in the best tertiles: TSQM side effects, 59% vs 4%; convenience, 52% vs 4%; effectiveness, 27% vs 13%; global, 26% vs 3%; PROMIS Fatigue, 44% vs 18%. CONCLUSIONS: Increased experience with SCIG consistently improved PROs, but our findings predicted that enhanced training and infusion characteristics improve patient treatment satisfaction beyond that achieved by experience alone.

Satisfaction With Statin Treatment Among Adult Coronary Artery Disease Patients: An Experience From a Resource-Constrained Setting.

BACKGROUND: Statins are the most widely prescribed hypolipidaemic drugs for coronary artery disease (CAD) patients, but have been found to cause muscle and nerve related adverse effects which can affect patient satisfaction with treatment. Literature on treatment satisfaction among statin users, especially from resource-limited settings is inadequate. The aim of this cross-sectional study was to assess the level of satisfaction with treatment among statin users and evaluate the relationship between adverse effects experienced by patients and their satisfaction with the medication. METHODS: This study included 300 adult CAD patients visiting the cardiology department of a tertiary care hospital in the northern region of India, who were prescribed statins for their diagnoses. An interviewer administered, validated and standardised Treatment Satisfaction Questionnaire for Medication (version 1.4) was used for data collection. RESULTS: Around three quarters of the population reported being overall satisfied with their medication. Mean scores were calculated for Effectiveness, Convenience, Side-Effects and Global Satisfaction. The patients reported high scores (above 60%) for all domains. Those experiencing any adverse effect were found to be more likely to report lower effectiveness. Additionally, medication effectiveness showed a positive correlation with overall treatment satisfaction. CONCLUSIONS: The study shows that treatment satisfaction is critical to gauge patient experiences with the treatment which can impact medication adherence and compliance. It's a crucial measure especially among CAD and other chronic disease patients since greater satisfaction can improve clinical outcomes. More research is warranted to better understand the relationship between medication effectiveness and treatment satisfaction.

Long-Term Satisfaction With Collagenase Clostridium Histolyticum for Peyronie's Disease: Clinical Predictors and Side Effect Profile.

INTRODUCTION: Collagenase clostridium histolyticum (CCH) therapy for Peyronie's disease (PD) yields satisfaction rates of roughly 50% to 67% within 1 year of treatment completion, but little is known about long-term patient satisfaction. Our study aimed to identify clinical predictors of long-term satisfaction with CCH for PD and the impact of its side effect profile. METHODS: The Treatment Satisfaction Questionnaire for Medication (TSQM) survey was distributed to patients who received CCH for PD at a high-volume men's health academic center from 2009 to 2022. Through retrospective chart review, demographic and clinical data of the disease were collected. RESULTS: Of 242 eligible patients, 80 (32.9%) responded, with questionnaires completed at a median of 5.1 (interquartile range 2.4-6.7) years after the last CCH injection. Thirty-four (42.5%) respondents reported satisfaction with CCH therapy. Older age was associated with significantly greater side effect domain scores (P < .004 for all). Curvature degree, plaque diameter, and plaque volume before CCH treatment, the mean reduction, and the mean percent reduction in these parameters were not significantly correlated with TSQM totals. Patients with greater final curvature and plaque volume measured after CCH completion had significantly lower TSQM totals (Spearman's ρ = -0.36, -0.32; P < .04 for both). Ten (12.5%) patients with depression and 10 (12.5%) patients who proceeded to surgery exhibited significantly decreased TSQM totals (P < .04 for both). CONCLUSIONS: While a significant proportion of our cohort reported long-term satisfaction with CCH therapy, patient satisfaction with CCH therapy is multifaceted. Our findings can be used to better counsel and manage patient expectations of treatment outcomes before initiating CCH.

The patient-reported outcomes for the new brand-generic teriflunomide in relapsing-remitting multiple sclerosis.

BACKGROUND: Patient-reported outcomes (PROs) provide valuable insights into the impact of disease-modifying therapies (DMTs) on patients' daily lives and disease progression. This study evaluates treatment satisfaction and tolerability among patients using a brand-generic Teriflunomide (Tebazio®, 14 mg tablet) manufactured by Zistdaru Danesh Biopharmaceuticals. MATERIALS AND METHODS: A Phase IV observational study was conducted on patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who were either initiated on or switched to Teriflunomide 14 mg. The primary focus was on the medication's safety. Patient satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM-14). Additionally, medication adherence and discontinuation rates were monitored. RESULTS: Of the 235 RRMS patients enrolled, participated in this study, all received the Teriflunomide treatment orally on a daily basis. Over the 18-month follow-up period, 25.96 % of patients discontinued the treatment. Discontinuation was mainly due to adverse events (11 %), lack of patient willingness to continue (12.7 %), and disease progression (4.2 %). The most commonly reported adverse events included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues. TSQM-14 scores demonstrated significant improvements over the 18-month period. A high medication adherence rate of 98.1 % was also recorded. CONCLUSION: Patients reported notable satisfaction with Teriflunomide, as reflected in their TSQM scores, which suggests a likelihood of improved patient adherence. The 14 mg brand-generic Teriflunomide was well-accepted by Iranian RRMS patients, with no significant concerns arising during the study. These findings also highlight the significance of patient-reported outcomes in DMTs, with potential benefits for adherence and clinical practice.

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

BACKGROUND: Topical 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. OBJECTIVE: Our aim was to investigate satisfaction of patients with psoriasis with topical therapy and to determine influencing factors. METHODS: Patients 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. RESULTS: Averaged 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. CONCLUSIONS: Participants 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.

Satisfaction with medication in older adult patients with chronic respiratory diseases: a multicenter cross-sectional observational study.

Purpose: To gain insight into medication satisfaction and factors associated with chronic respiratory disease, particularly chronic obstructive pulmonary disease (COPD) in older adults, focusing on public health issues and improving the health of the older adult population. Methods: This cross-sectional study was conducted from October 2022 to November 2022 in 24 hospitals in different regions of Hunan Province, China. Older adult patient treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication version II. Multiple regression analysis was used to identify factors independently associated with patient treatment satisfaction. Results: Only 15.9% of all patients scored above 80 in the effectiveness domain, while 11.6 and 16.5% scored above 80 in the convenience and global satisfaction domains, respectively, while 17.3% reported having side effects. Interstitial lung disease was associated with lower drug satisfaction than other disorders (p < 0.05). Multifactorial regression analysis showed that age, education background, profession, and smoking status were independently associated with satisfaction among patients with chronic respiratory diseases (p < 0.05). Education background, profession, CAT score, number of acute exacerbations, duration of home oxygenation and duration of home ventilator use were independently associated with satisfaction in patients with COPD (p < 0.05). Conclusion: Low satisfaction with chronic respiratory drug therapy was associated with age, education background, profession and smoking status. Satisfaction was lower for patients with interstitial lung disease. For COPD, CAT score, education background, profession, number of acute exacerbations, home oxygen and ventilator use influence satisfaction. Clinicians can identify appropriate patients and communicate effectively with them throughout treatment and follow-up, vigorously promote smoking cessation and home oxygen therapy, increase medication satisfaction, especially among older adults, and in turn improve public health and the quality of life of older adults.

Effectiveness of Omeprazole in Acid Peptic Disease: A Real-World, Patient-Reported Outcome Measures Study.

Objectives This prospective study assessed the effectiveness and patient satisfaction of four-week omeprazole therapy in acid peptic disease (APD). Methods This was an observational, post-marketing, real-world evidence, patient-reported outcome (PRO) measures study. Patients visiting the five study sites across India with symptoms of APD, and who were prescribed oral omeprazole (20/40 mg per day) for at least four weeks were enrolled after obtaining informed consent. Study assessments included frequency and severity of symptoms and overall satisfaction reported by the patients using the Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire. The satisfaction with therapy was reported by the patients using the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire. Both PAGI-SYM and TSQM were reported by patients on days 14 and 28. Omeprazole safety was assessed based on the adverse events reported by the patients. Results A total of 96 (62 males and 34 females) patients were included in the study, of which 38.54% had significant findings related to APD at baseline. The proportion of patients with symptoms reduced to 16.67% on day 14 and 8.33% on day 28 with omeprazole therapy. The PAGI-SYM total scores at baseline were 41.32 (15.487), which reduced to 20.86 (11.620) on day 14 (p < 0.0001), and to 8.93 (8.361) on day 28 (p < 0.0001). Significant reductions were also seen in individual symptom scores. The TSQM total scores increased to 36.67 (range: 13 to 63) on day 28 from 34.69 (range: 12 to 58) on day 14. Improvement in scores for all domains of TSQM (effectiveness, convenience, and global satisfaction) was seen on day 28. Improvement in reflux symptoms was reported by 46.74% and 68.48% of patients on day 14 and day 28, respectively. Four (4.17%) patients reported adverse events, which were of mild severity and were unrelated to omeprazole. Conclusions Omeprazole provides significant improvement in PAGI-SYM and TSQM questionnaires on day 14 and day 28. Patients reported the omeprazole-based therapy as effective, convenient, and satisfactory. Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, and reflux oesophagitis.

Treatment satisfaction and response in patients with severe alopecia areata under treatment with diphenylcyclopropenone.

Background and Aims: Alopecia areata (AA) is an autoimmune disease of hair follicles. Treatments currently include topical and intralesional corticosteroids and contact immunotherapy; however, the overall prognosis is usually unfavorable. In severe AA, topical immunotherapy with diphenylcyclopropenone (DPCP) is preferred. Since its effectiveness is heterogeneous and there are several side effects, we decided to measure the patients' satisfaction using the "Version II of the Treatment Satisfaction Questionnaire for Medication," which investigates satisfaction with effectiveness, side effects, convenience, and global satisfaction. Methods: We examined 100 patients under treatment with DPCP for treatment response, asked them to respond to the questionnaire, and calculated their overall scores out of 400. We then investigated the association between the patients' characteristics with their treatment response and satisfaction. Results: The overall satisfaction of patients was 257/400. We observed a significant association between patients' satisfaction scores on effectiveness and global satisfaction with their response to treatment (p < 0.001). The patients' satisfaction with the treatment's convenience had a significantly positive association with the age of receiving the diagnosis (p = 0.028). The overall treatment satisfaction was significantly associated with treatment response (276 vs. 213, p = 0.000). Conclusion: Although there are currently no gold standard treatments for severe AA, DPCP demonstrated a 71% response to treatment, and patients with response were significantly more satisfied with their treatment.

Health-related quality of life and treatment satisfaction in Palestinians with rheumatoid arthritis: a cross-sectional study.

BACKGROUND: Studying health-related quality of life (HRQoL) and treatment satisfaction have helped in understanding how to optimize rheumatoid arthritis (RA) treatment outcomes and find ways to alleviate signs and symptoms among patients. OBJECTIVE: In this study, our objective was to evaluate the association between satisfaction with care and HRQoL among RA patients from northern Palestine. In addition, this study also aimed to determine the associations between the clinical characteristics of patients with RA with treatment satisfaction and HRQoL. METHODS: This was a multicenter cross-sectional study conducted between July and October 2018. Patients with RA diagnosis who presented at rheumatology clinics were interviewed. The SF-36 short questionnaire was used to assess HRQoL and Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 to assess treatment satisfaction among study groups. We use descriptive and comparative statistics to present the results. RESULTS: A total of 283 patients were included. Several sociodemographic and clinical characteristics were found to be associated with poor HRQoL scores and low treatment satisfaction. The physical component summary (PCS) was negatively associated with age, patients' self-reported disease activity, duration of the disease, and the total number of medications taken by the patient, and was positively associated with educational background, employment, and household income. The mental component summary (MCS) was negatively associated with patients' self-reported disease activity and the patient's total number of comorbid diseases. The number of comorbid diseases was negatively associated with effectiveness. All HRQoL subscales were significantly correlated with treatment satisfaction. The range of correlation with PCS was between 0.272 for convenience and 0.425 for side effects (p < 0.001). Similarly, the highest correlation with MCS was 0.458 for side effects, and the lowest was 0.337 for convenience (p < 0.001). CONCLUSIONS: The current study found that HRQoL was significantly correlated with treatment satisfaction. Furthermore, the results of this study showed that HRQoL and treatment satisfaction are likely to be affected by sociodemographic and clinical characteristics. These results may be beneficial in clinical practice, mainly in the early treatment of patients with RA, at a stage where it is still possible to increase treatment satisfaction.

Validating the "Treatment Satisfaction Questionnaire for Medication" in Persian and Evaluating Treatment Satisfaction Among Patients With Psoriasis.

OBJECTIVES: Psoriasis is a dermatological condition often associated with systemic comorbidities such as arthritis. Because of the vital role of treatment compliance in improvement in patients' condition and the scarcity of studies on this subject in Iran, we decided to measure and compare treatment satisfaction (as a predictor of compliance) of patients with psoriasis by using the Treatment Satisfaction Questionnaire for Medication (TSQM). METHODS: We administered the TSQM version II to adult patients with psoriasis, referring to the clinics and wards of the Razi hospital. First, we translated and investigated the validity and reliability of the TSQM in a group of 34 patients; then, we measured the satisfaction of 100 patients with psoriasis who were receiving topical, phototherapy, or systemic or biologic medications. RESULTS: Content validity was established by experts' review of the translation and by comparing the results to those of previous studies. Then, reliability was confirmed by calculating reliability and agreement measures (Cronbach's alpha = 0.864, intraclass correlation coefficient = 0.984, and Pearson's correlation = 0.969). Biologic medications showed the highest satisfaction score in "effectiveness," "convenience," "global satisfaction," and "total score" (P = .000). Topical treatments demonstrated the highest "side effects" score (P = .006). Patients older than 50 years were significantly more satisfied than younger patients (P = .029). Patients with a Psoriasis Area Severity Index of 5 or more and patients with psoriatic arthritis reported lower satisfaction (P = .012, P = .000). Treatment satisfaction of patients with arthritis was higher with biologic medications than with traditional systemic medications (P = .000). CONCLUSIONS: TSQM, which had not been used in Persian before, is valid and reliable in Persian and provides reproducible results. Patients reported the highest satisfaction with the use of biologic agents, which was associated with age, Psoriasis Area Severity Index, and arthritis.

Multiarm study comparing patient-reported and clinical outcome measures in patients undergoing antipsoriatic therapy with non-biological systemic agents in a real-world setting.

BACKGROUND: Although the inclusion of patients' preferences and needs is essential for therapy adherence, the assessment of patient-reported outcome measures in clinical trials is often neglected. Therefore, the aim of this study was to quantify several patient-reported outcome measures in psoriasis patients undergoing systemic therapy in a real-life clinical setting. METHODS: This clinical trial has been designed as a prospective, multiarm study to investigate the treatment satisfaction, adherence to therapy, quality of life (QoL), and clinical response in a real-life clinical setting during the initial 6 months of treatment with apremilast, methotrexate, and fumaric acids in 80 patients suffering from plaque psoriasis. RESULTS: The treatment satisfaction for the three systemic therapies was rated 'sufficient' with a mean (±SD) Treatment Satisfaction Questionnaire for Medication (TSQM) score of 275.0 (±62.7). Most potential for improvement was seen in the 'effectiveness' domain (54.3 ± 21.5). The highest treatment satisfaction level in all four domains (convenience, effectiveness, global satisfaction, and side-effects) was seen in the methotrexate group with a mean TSQM score of 306.3 ± 50.9, followed by apremilast (267.1 ± 61.6) and fumaric acids (254.9 ± 65.0; p = 0.005). Analysis of the TSQM revealed a considerable discrepancy between patient-reported clinical response and the actual Psoriasis Area and Severity Index (PASI) reduction. This applies equally to the patient- vs. physician-reported side-effects. CONCLUSIONS: This real-life study demonstrates that an adequate assessment of antipsoriatic drugs by PASI-reduction alone is not sufficient and underlines the importance of patient-reported outcome measures not only in clinical trials, but also for improved patient care.

Immunoglobulin replacement therapy in patients with immunodeficiencies: impact of infusion method on patient-reported outcomes.

BACKGROUND: Understanding the impact of different immunoglobulin (Ig) infusion methods (intravenous [IVIg] and subcutaneous [SCIg]) upon treatment experience can potentially facilitate optimization of patient outcomes. Here, the perspective of patients with primary and secondary immunodeficiency diseases (PID and SID, respectively) receiving IVIg and SCIg was evaluated, in terms of treatment satisfaction, accounting for treatment history, using Association des Patients Immunodéficients du Québec (APIQ) survey data. METHODS: The online APIQ survey (shared October 2020-March 2021) of patients with immunodeficiencies in Canada contained 101 questions on: Ig use, history, and detailed infusion characteristics; as well as structured patient-reported outcomes such as treatment satisfaction (via TSQM-9), symptom state (via PASS), general health perception (via GHP), and physical and mental function (via PROMIS). Adult respondents (≥ 18 years old) currently using Ig were compared by their current Ig infusion method (IVIg or SCIg cohort) overall, and in a sub-analysis, the IVIg cohort was compared with the SCIg cohort after stratification by respondents who started SCIg when naïve to Ig ('SCIg naïve') or with previous IVIg experience ('SCIg switch'). RESULTS: In total, 54 respondents currently used IVIg and 242 used SCIg. The average duration per infusion of a weekly SCIg infusion was significantly shorter compared with the average duration of a 3-4 weekly IVIg infusion (p < 0.001). The SCIg cohort was associated with significantly higher scores for the TSQM-9 effectiveness domain compared with the IVIg cohort. The scores for TSQM-9 convenience and global satisfaction domains were similar in the two cohorts. The SCIg cohort was also associated with a significantly higher proportion of respondents who were in an acceptable symptom state and a lower proportion who reported very poor or poor perception of health compared with the IVIg cohort. Further, the SCIg naïve subgroup was associated with significantly higher TSQM-9 effectiveness and convenience domain scores compared with the IVIg cohort, while there was no significant difference between the SCIg switch subgroup and the IVIg cohort in terms of convenience. CONCLUSIONS: A better understanding of how different IgRT administration methods impact treatment experience and satisfaction may assist with informed treatment decision making and ultimately further improvements in patient outcomes.

Suboptimal Control of Asthma Among Diverse Patients: A US Mixed Methods Focus Group Study.

Purpose: The US National Asthma Education and Prevention Program updates and Global Initiative for Asthma report encourage considering the patient perspective to improve asthma control. The objective of the present study was to collect data about the perceptions, experiences, and concerns of adult patients and caregivers of children with asthma regarding rescue, maintenance, and oral corticosteroid treatments. Patients and Methods: In-person focus groups were conducted in three cities across the US. Participants also completed patient-reported outcome measures assessing asthma control and experiences. Results: Focus groups were conducted in demographically and clinically diverse adults with asthma (five groups, n=34), caregivers of children with asthma (five groups, n=35), and adults with a dual diagnosis of asthma and chronic obstructive pulmonary disease (one group, n=5). Only 28% of patients were well-controlled by Asthma Control Test/Asthma Control Test-Caregiver Report and 18% by Asthma Impairment and Risk Questionnaire. Forty-four percent of participants reported not following their prescribed medical plan. Four key themes emerged from the focus groups: (1) asthma symptom control and monitoring are often inadequate; (2) treatments are often used incorrectly; (3) communication between health care professionals and patients or caregivers is often ineffective; and (4) concerns related to treatment and desires to improve treatment. Conclusion: Control of asthma symptoms is suboptimal in the vast majority of patients and both patients and caregivers do not feel sufficiently informed about asthma. Health care providers should be encouraged to engage patients and caregivers in shared decision making for managing asthma and selecting treatments that integrate patient values, preferences, and lifestyles.

Assessment of Patient Satisfaction with Generic Medication in Emerging Economy Using the Treatment Satisfaction Questionnaire for Medication.

The purpose of this study was to explore the factors influencing patient satisfaction with generic medication in India using the treatment satisfaction questionnaire for medication (TSQM) scale. This study proposed a set of hypotheses that were tested using structural equation modeling (SEM). This study was based on primary data collected from 542 sample respondents using the judgmental sampling method. The findings of this study revealed an affirmative relationship of effectiveness and convenience with patient satisfaction with generic medication. The study's findings demonstrated that the TSQM is a psychometrically sound tool with high reliability and construct validity. Path analysis revealed that the effectiveness and convenience of generic medication contributed significantly to patient satisfaction, with standardized coefficients of 0.254 and 0.237, respectively.

Burden of allergic rhinitis and impact of MP-AzeFlu from the patient perspective: pan European patient survey.

OBJECTIVE: The aims of this survey were to (1) assess the burden of allergic rhinitis (AR) from the patient perspective, (2) investigate MP-AzeFlu use in real life and its impact on patients' lives and (3) explore factors associated with treatment satisfaction. METHODS: A cross-sectional, quantitative, online, questionnaire-based survey was conducted in seven European countries (March-June 2019). Questions explored AR burden and treatment satisfaction. Satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication 9-item (TSQM-9; max score = 100). Participants (aged ≥18 years) had a doctor/healthcare provider confirmed AR diagnosis and used MP-AzeFlu within the last year. RESULTS: Pre-MP-AzeFlu treatment, participants (n = 1004) reported an average of 3.3 (SD:3.5) doctor visits/year, 8.1 (SD:11.0) days/year absenteeism and 15.8 (SD:18.9) days/year presenteeism due to AR. Only 48% of participants used MP-AzeFlu twice/day as recommended. Post-MP-AzeFlu 57% of participants reported better QoL, 47% reported fewer doctor visits and 52% discontinued polypharmacy. Absenteeism and presenteeism were reduced by 2.5 (SD 10.0) and 7.3 (SD:16.0) days/year, respectively. 70% of participants were more/much more satisfied with MP-AzeFlu versus previous AR treatment(s), and ≥70% were satisfied/extremely satisfied with its ability to prevent/treat AR, relieve symptoms and with its onset of action. Mean global, effectiveness and convenience TSQM-9 scores were 70.0 (SD:19.8), 68.3 (SD:21.6) and 72.7 (SD:20.4), respectively. Treatment satisfaction and effectiveness were significantly improved when MP-AzeFlu was taken as recommended. CONCLUSIONS: The impact of AR on patients' lives remains high. Real-life use of MP-AzeFlu reduces that impact and is associated with a high level of effectiveness, convenience and global satisfaction.

Treatment satisfaction in 5q-spinal muscular atrophy under nusinersen therapy.

BACKGROUND: Nusinersen was the first approved disease-modifying therapy for all 5q-spinal muscular atrophy (SMA) patients regardless of age or disease severity. Its efficacy in adults has recently been demonstrated in a large cohort by motor outcome measures, which were only partially suitable to detect changes in very mildly or severely affected patients. Patient-reported outcome measures (PROs) have been suggested as a valuable addition. Here, we aimed to assess treatment satisfaction and investigate whether it may be a useful PRO to monitor SMA patients. METHODS: We enrolled 91 mainly adult 5q-SMA patients treated with nusinersen in a national, multicenter, cross-sectional observational study. 21 patients underwent longitudinal follow up. Patients' satisfaction with treatment in four dimensions (global, effectiveness, convenience, side effects) was assessed by the Treatment Satisfaction Questionnaire for Medication German version 1.4 (TSQM-1.4©) and related to clinical parameters, motor scores, and treatment duration. RESULTS: More than 90% of SMA patients were consistently satisfied over a median treatment duration of 10 months. Highest mean scores were observed in the dimensions 'side effects,' 'global satisfaction,' and 'effectiveness' (93.5 ± 14.8 versus 73.1 ± 21.0 and 64.8 ± 20.6, respectively). Patients' satisfaction with the convenience of treatment was considerably lower (43.6 ± 20.2). Interestingly, satisfaction with the effectiveness was higher in ambulatory (p = 0.014) compared with non-ambulatory patients and directly correlated to motor outcome measures. Five non-ambulatory patients withdrew from therapy. All of them presented with a deterioration of motor outcome measures and reported dissatisfaction with treatment effectiveness and convenience. CONCLUSION: Most patients were satisfied with nusinersen treatment effectiveness. Less severely affected patients indicated higher satisfaction. The TSQM-1.4© helped to identify therapy non-responders, who mainly addressed dissatisfaction with effectiveness and convenience. We suggest introducing the TSQM-1.4© as an additional PRO in SMA into clinical practice.

Satisfaction of Patients and Physicians with Treatments for Rheumatoid Arthritis: A Population-Based Survey in China.

PURPOSE: Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by chronic destructive synovitis and possible multisystem involvement. This study aimed to survey the treatment satisfaction of physicians and patients with RA, and to explore the potential factors. PATIENTS AND METHODS: This cross-sectional study was conducted in 12 centers across China between March 2018 and April 2018. The Treatment Satisfaction Questionnaire for Medication version II was used to assess the treatment satisfaction of patients and physicians. Multivariable regression analysis was used to determine the factors independently associated with treatment satisfaction of patients. RESULTS: The patients' satisfaction (n=335) with biological disease-modifying antirheumatic drugs (bDMARDs) was higher than physicians' satisfaction (n=146) regarding the side effects (95.0±14.3 vs 84.6±15.7, P<0.001) and convenience (74.6±21.2 vs 69.1±16.5, P=0.002). Among physicians, global satisfaction with bDMARDs was higher than that with conventional synthetic DMARDs (csDMARDs). The multivariable regression analysis showed that age was positively associated with satisfaction of patients, while college or above education and self-assessment of disease severity were inversely associated with satisfaction. Treatment satisfaction was associated positively with the quality of communication with the physician and inversely with treatment costs. CONCLUSION: For bDMARDs, the treatment satisfaction of patients with RA is generally higher than that of physicians'. Physicians' satisfaction with bDMARDs is higher than with csDMARDs. Age, education, disease severity, communication with the physician, and treatment costs are independently associated with the treatment satisfaction among patients. Physician-patient communication should be improved in clinical practice. Treatment costs should be taken into account when physicians make decisions.

Health-Related Quality of Life and the Relationship to Treatment Satisfaction in Patients with Multiple Sclerosis: Insights from a Large Observational Study.

INTRODUCTION: In patients with multiple sclerosis (MS), fatigue, depression, and physical disability are important determinants that negatively affect health-related quality of life (HRQoL). In studies about MS, HRQoL and treatment satisfaction are emerging endpoints representing the patients' perspective. However, the association of HRQoL and MS treatment satisfaction has not been evaluated so far. PURPOSE: Our objective was to evaluate the relationship of different dimensions of HRQoL and treatment satisfaction (effectiveness, side effects, convenience), and to assess which factors of treatment satisfaction, besides disease-related and sociodemographic explanatory factors, can best describe HRQoL. PATIENTS AND METHODS: We analyzed data from a cross-sectional, observational multicenter study in Germany (THEPA-MS, N=2990 eligible patients for first-line treatment). The instruments used were the SF-36 for HRQoL and the TSQM for treatment satisfaction. Correlation analyses, classification and regression trees and multivariate linear regression with the least absolute shrinkage and selection operator (LASSO) for global variable selection were used to analyze explanatory factors of HRQoL. RESULTS: The SF-36 physical summary score was 45.49 ±12.03 and mental component summary score 42.87 ±12.12, with currently untreated patients (N=250) reporting lower HRQoL than patients under first-line treatment (N=2740) (p<0.001). Physical disability (standardized beta (b)=0.408) was the strongest cross-sectional predictor for physical health, followed by employment status (b=0.163), age (b=0.159) and treatment satisfaction in terms of side effects (b=0.146) and effectiveness (b=0.137). For the mental summary health dimension, presence of a major depressive episode (b=0.234) had the greatest impact, followed by satisfaction with side effects (b=0.152) and effectiveness (b=0.131). CONCLUSION: Satisfaction with the effectiveness and side effects of treatment was part of the main independent explanatory variables for mental and physical HRQoL in patients with MS. To improve HRQoL, patients' needs and satisfaction measures may be integral part of disease management beyond treatment of physical disability, depression or fatigue.

Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation.

Aims: The Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) are validated treatment satisfaction patient-reported outcome (PRO) instruments. The ACTS includes two domains: Burdens and Benefits; the TSQM-II includes four: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Japanese-language versions of the ACTS and TSQM-II have been developed and linguistically validated. This study aimed to assess their psychometric properties in Japanese patients with atrial fibrillation (AF). Materials and methods: ACTS and TSQM-II data from 534 patients with AF were collected in a Japanese post-marketing surveillance study of a direct oral-anticoagulant, rivaroxaban. Four key psychometric properties, in line with best practice guidelines from the US Food and Drug Administration, were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (i.e. internal consistency reliability, test-retest reliability), and construct validity (i.e. convergent validity and known groups). Results: ACTS Burdens and Benefits and TSQM-II Effectiveness, Convenience, and Global Satisfaction scales were found to be acceptable (e.g. item-level missing data at baseline <4%), with all scales having good internal consistency (Cronbach's alpha > 0.80). test-retest reproducibility intraclass correlation coefficients for the ACTS Burdens and Benefits were 0.59 and 0.65, respectively, and between 0.54-0.61 for the TSQM-II scales. Known-groups validity for the ACTS and TSQM-II was supported by differences in scale scores by positive and negative impact (p < 0.05). Correlations between the ACTS and TSQM-II (convergent validity) were lower than expected (range r = 0.09-0.48), but in line with the original ACTS development study. Limitations: Evaluation of test-retest reproducibility was limited by assessment period, which was longer (3 months) than recommended guidelines (usually up to 2 weeks). Conclusions: Overall, Japanese versions of ACTS and TSQM-II scales satisfied internal consistency reliability and traditional validity criteria. Our study supports the ACTS and TSQM-II as appropriate PRO instruments to measure satisfaction with anticoagulant treatment in Japanese patients with AF. Trial registration: NCT01598051, clinicaltrials.gov; registered April 20, 2012.