Health Quality and Treatment Satisfaction in IEI Patients; Not Only IgRT but Comorbidities

SummaryThe purpose of this study was to assess the association of GI events with HRQoL and treatment satisfaction. The effect of baseline GI events persisted through 1 year of follow-up, as indicated by lower EQ-5D, OPAQ-SV, and treatment satisfaction scores among patients with vs without baseline GI events. The presence of GI events is an independent predictor of decreased HRQoL and treatment satisfaction in patients being treated for osteoporosis.IntroductionThe goal of this study was to assess the association of gastrointestinal (GI) events with health-related quality of life (HRQoL) and treatment satisfaction in patients being treated for osteoporosis.MethodsMUSIC OS was a multinational, prospective, observational study examining the impact of GI events on osteoporosis management in postmenopausal women. In this analysis, HRQoL and treatment satisfaction were assessed at baseline, 6, and 12 months and compared between patients with and without GI events. Covariate-adjusted scores were calculated using multivariate least-squares regression analysis, and differences between the mean scores of patients with and without baseline and post-baseline GI events were determined.ResultsAmong the 2959 patients in the analysis, unadjusted scores at each time point were lower (i.e., worse) for patients with GI events than patients without GI events. In adjusted analyses, the effect of baseline GI events persisted through 1 year of follow-up, as indicated by lower EQ-5D and OPAQ-SV scores at 12 months among patients with vs without baseline GI events (−0.04 for the EQ-5D utility score, −5.07 for the EQ-5D visual analog scale, −3.35 for OPAQ physical function, −4.60 for OPAQ emotional status, and −8.50 for OPAQ back pain; P ≤ 0.001 for all values). Decrements in month 12 treatment satisfaction scores were −6.46 for patients with baseline GI events and −7.88 for patients with post-baseline GI events.ConclusionsThe presence of GI events is an independent predictor of decreased HRQoL and treatment satisfaction in patients being treated for osteoporosis.

Many rheumatoid arthritis (RA) patients prioritize pain improvement in treatment. As pain can result from various causes, including noninflammatory factors such as central sensitivity syndrome (CSS), we hypothesized that CSS might impact treatment satisfaction. In this cross-sectional study, we assessed the CSS effects on clinical disease activity and treatment satisfaction in RA patients. In total, 220 consecutive RA patients receiving long-term follow-up were evaluated for clinical disease activity and treatment satisfaction. CSS was evaluated using the Central Sensitization Inventory (CSI). An overall score of ≥40 indicates the presence of CSS. We queried "How satisfied are you with your treatment?"; answers included (a) very satisfied, (b) satisfied, (c) not satisfied, or (d) very dissatisfied. For univariate analysis, we condensed these answers into "dissatisfied" or "satisfied." We also evaluated treatment satisfaction using the visual analog scale (VAS), with scores ranging from 0 mm (very dissatisfied) to 100 mm (very satisfied). Of the 220 patients, 17 (7.7%) were classified as having CSS. CSI score was significantly correlated with the clinical disease activity index (CDAI; r = .322, p < .01) and treatment satisfaction (r = -.336, p < .01). Regarding treatment satisfaction, univariate analysis revealed that patient global assessment (PtGA), pain VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score in 28 joints with C-reactive protein, CDAI, and CSI scores of patients who were satisfied with treatment differed significantly from those of dissatisfied patients. Multivariate analysis revealed that CSI, PtGA, and HAQ-DI scores were associated with treatment satisfaction. In RA patients, CSS may affect the disease activity index and reduce treatment satisfaction.

Introduction: To evaluate the effect of diarrhea adverse events (AEs) on health-related quality of life (HRQOL) and treatment satisfaction (TS) in patients with chronic idiopathic constipation (CIC). Methods: Data were pooled from 2 similarly designed phase 3 trials in CIC patients of linaclotide, the first-in-class guanylate cyclase-C agonist FDA-approved treatment for adults with CIC and irritable bowel syndrome with constipation. Presence and severity (ie, mild, moderate, severe) of diarrhea episodes were recorded by trial investigators as AEs at any time during the 12-week treatment period in both trials. HRQOL was assessed at baseline and week 12 using the patient assessment of constipation quality of life questionnaire (PAC-QOL) overall score (range: 0-4, lower scores indicate better HRQOL); TS was evaluated at weeks 2, 4, 8, and 12 with a 5-point scale (1=not at all satisfied, 5=very satisfied). Data were evaluated longitudinally by pairing the most severe diarrhea episode with the nearest HRQOL/TS assessment following the episode. Change-from-baseline to week 12 in PAC-QOL overall score and mean TS score at week 12 were evaluated by treatment (linaclotide 145 mcg vs. placebo) stratified by diarrhea presence/severity. Patients with no recorded diarrhea episodes were the reference group. Longitudinal multivariate models examined adjusted associations between diarrhea episodes and HRQOL/TS, controlling for patient characteristics and change in abdominal (pain, bloating, discomfort) and bowel symptoms (stool frequency, stool consistency, straining). Results: Of 1,276 patients randomized, 854 received a treatment of interest for these analyses (linaclotide 145 mcg n=430, placebo n=424), of which 746 completed HRQOL and TS assessments (linaclotide 145 mcg n=369, placebo n=377). Of these, 105 diarrhea episodes were reported in 98 patients (n=51 mild, n=46 moderate, n=8 severe). Mean TS and change in PAC-QOL overall scores did not significantly differ in linaclotide or placebo patients with diarrhea AEs vs. those with no recorded diarrhea AEs (TS=3.52 vs. 3.28; p=0.269 for linaclotide and 2.80 vs. 2.21; p=0.185 for placebo; change in PAC-QOL=-0.96 vs. -0.95; p=0.340 for linaclotide and -0.98 vs. -0.57; p=0.207 for placebo). For both linaclotide and placebo, the presence of diarrhea (any severity) had no statistically significant impact on TS or HRQOL, even after controlling for confounders. Conclusion: Presence of diarrhea AEs did not negatively affect HRQOL or TS among CIC patients receiving linaclotide 145 mcg. Disclosure - Michael Munsell and Robert Griffiths are employees of Boston Health Economics, Inc, which is a consultancy whose activities related to the project are funded by Forest Research Institute, and Ironwood Pharmaceuticals; Huan Huang is a consultant to Ironwood Pharmaceuticals, Inc., and Forest Research Institute; Jessica Buono and Robyn Carson are employees of Forest Research Institute and own stock and/or stock options in Forest Laboratories, Inc.; William Spalding and Douglas Taylor are employees of Ironwood Pharmaceuticals, Inc., and own stock and/or stock options in Ironwood Pharmaceuticals. This research was supported by an industry grant from Forest Research Institute and Ironwood Pharmaceuticals.

Introduction: To evaluate the effect of diarrhea adverse events (AEs) on health-related quality of life (HRQOL) and treatment satisfaction (TS) in patients with irritable bowel syndrome with constipation (IBS-C). Methods: Data were pooled from 2 similarly designed phase 3 trials in IBS-C patients of linaclotide, the first-in-class guanylate cyclase-C agonist FDA-approved treatment for adults with IBS-C or chronic idiopathic constipation. Presence and severity (i.e., mild, moderate, severe) of diarrhea episodes were recorded by trial investigators as AEs at any time during the 12-week treatment period in both trials. HRQOL was assessed at baseline and week 12 using the irritable bowel syndrome quality of life (IBSQOL) questionnaire overall score (range: 0-100, higher scores indicate better HRQOL); TS was evaluated at weeks 2, 4, 8, and 12 with a 5-point scale (1=not at all satisfied, 5=very satisfied). Data were evaluated longitudinally by pairing the most severe diarrhea episode with the nearest HRQOL/TS assessment following the episode. Change-from-baseline to week 12 in IBS-QOL overall score and mean TS at week 12 were evaluated by treatment (linaclotide 290 mcg vs. placebo) stratified by diarrhea presence/severity. Patients with no recorded diarrhea episodes were the reference group. Longitudinal multivariate models examined adjusted associations between diarrhea episodes and HRQOL/TS, controlling for patient characteristics and change in abdominal (e.g., pain, bloating, discomfort) and bowel symptoms (stool frequency, stool consistency, straining). Results: Of 1,602 patients randomized, 1,336 completed HRQOL and TS assessments (linaclotide 290 mcg n=654, placebo n=682); of these, 129 diarrhea episodes were reported in 122 patients (n=69 mild, n=53 moderate, n=7 severe). Mean TS and change in IBS-QOL did not significantly differ in linaclotide patients with diarrhea AEs vs. those with no recorded diarrhea AEs (TS=3.54 vs. 3.40; p=0.433; change in IBS-QOL=18.47 vs. 19.06; p=0.408, respectively). Change in IBS-QOL also did not significantly differ for placebo patients with diarrhea AEs vs those with no recorded diarrhea AEs (8.54 vs. 13.58; p=0.931, respectively). For both linaclotide and placebo, the presence of diarrhea (any severity) had no statistically significant impact on HRQOL, even after controlling for confounders. A statistically significant impact on TS was found among linaclotide patients with a recorded episode of severe diarrhea (-0.80, p=0.001); among placebo patients, mild (-0.40, p=0.042) and severe (-1.55, p=0.046) diarrhea AEs had a significant impact. Conclusion: Presence of mild/moderate diarrhea AEs did not negatively affect HRQOL or TS among IBS-C patients receiving linaclotide 290 mcg. Disclosure - Michael Munsell and Robert Griffiths are employees of Boston Health Economics, Inc, which is a consultancy whose activities related to the project are funded by Forest Research Institute, and Ironwood Pharmaceuticals; Huan Huang is a consultant to Ironwood Pharmaceuticals, Inc., and Forest Research Institute; Jessica Buono and Robyn Carson are employees of Forest Research Institute and own stock and/or stock options in Forest Laboratories, Inc.; William Spalding and Douglas Taylor are employees of Ironwood Pharmaceuticals, Inc., and own stock and/or stock options in Ironwood Pharmaceuticals. This research was supported by an industry grant from Forest Research Institute and Ironwood Pharmaceuticals.

PurposeRheumatoid 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 MethodsThis 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.ResultsThe 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.ConclusionFor 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.

BackgroundThe correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole.MethodsAdult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.ResultsAmong the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.ConclusionsEthnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.

ObjectiveThe main aim of this study was to assess the association between adherence to the traditional Mediterranean diet (MedDiet) and health-related quality of life (HRQoL) and treatment satisfaction in patients with type 2 diabetes mellitus (T2DM).MethodsThis cross-sectional study included 294 patients with T2DM (146 with diabetic retinopathy and 148 without retinopathy). HRQoL and treatment satisfaction were assessed with the Audit Diabetes-Dependent Quality of Life and Diabetes Treatment Satisfaction Questionnaires, respectively. Adherence to the MedDiet was evaluated with the relative Mediterranean Diet Score (rMED). The rMED was added to multivariate linear regression models to assess its relative contribution as a quantitative as well as a qualitative variable after recoding to maximize each of the model’s coefficients of determination to explain quality of life as well as treatment satisfaction dimensions.ResultsThe adherence to the Mediterranean diet showed no significant association with the overall quality of life score. However, rMED was associated with some HRQoL dimensions: travels, self-confidence and freedom to eat and drink (p = 0.020, p = 0.015, p = 0.037 and p = 0.015, respectively). Concerning treatment satisfaction, rMED was positively associated with its overall score (p = 0.046), and especially with the understanding of diabetes (p = 0.0004) and treatment recommendation (p = 0.036), as well as with the perceived frequency of hyperglycaemias (p = 0.039).ConclusionAdherence to the Mediterranean diet was associated with greater treatment satisfaction in patients with T2DM. Although we found no association with overall HRQoL, adherence to this dietary pattern was associated with some quality of life dimensions.

Effects of health literacy on treatment outcome and satisfaction in patients with mallet finger injury

IntroductionWe previously reported several factors that cross-sectionally correlate with treatment satisfaction in Japanese patients with type 2 diabetes visiting diabetes clinics. The aim of this study is to identify factors associated with longitudinal changes in treatment satisfaction in patients with type 2 diabetes.MethodsThe study included 649 patients with type 2 diabetes treated with oral glucose-lowering agents who completed the first questionnaire in 2016. The collected data included scores from the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and other parameters regarding diabetes treatment. We analyzed 1-year longitudinal changes in DTSQ scores and investigated factors associated with these changes.ResultsUnivariate linear regression analyses showed that changes in body weight, adherence to diet therapy, adherence to exercise therapy, cost burden, motivation for treatment, regularity of mealtimes, and perceived hypoglycemia correlated with changes in DTSQ scores. On the basis of multiple linear regression analyses, a decrease in hypoglycemia (β ± SE = − 0.394 ± 0.134, p = 0.0034), cost burden (β ± SE = − 0.934 ± 0.389, p = 0.017), and an increase in treatment motivation (β ± SE = 1.621 ± 0.606, p = 0.0077) correlated with DTSQ score increases, suggesting that motivation for treatment had the strongest impact on score increases. Subgroup analyses revealed that an increase in motivation for treatment most significantly correlated with a DTSQ score increase in obese and poor glycemic control groups, regardless of age.ConclusionThis is the first longitudinal study clarifying that an increase in motivation for treatment most strongly correlates with an increase in DTSQ score in patients with type 2 diabetes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01235-x.

PurposeCardiovascular disease is the most prevalent health problem associated with poorer health-related quality of life (HRQoL). We aimed to assess HRQoL and treatment satisfaction of cardiovascular disease patients in Ethiopia.MethodsA cross-sectional survey was conducted among adults attending the outpatient cardiac clinic at Tikur Anbessa Specialized Hospital from July to September 2021. Patients were recruited consecutively during follow-up visits. Treatment Satisfaction Questionnaire for Medication and European Quality of life questionnaires were used to evaluate treatment satisfaction and HRQoL, respectively. Kruskal-Wallis and Mann-Whitney U-tests were used to compare utility weights between patient subgroups. Utility values were computed using disutility weights of the Ethiopian general population derived using a hybrid regression model. Tobit regression modeling was used to explore factors associated with poor HRQoL. Statistical significance was determined at p < 0.05.ResultsA total of 357 patients participated in the study with a mean age of 49.3 ± 17.8 years. The most frequently reported health problems were pain/discomfort (75.4%), followed by mobility (73.4%). The median (interquartile range) European Quality questionnaires five dimensions with five levels utility (EQ-5D-5L) and European Quality of life Visual Analog Scale scores were 0.84 (0.55–0.92) and 70.0 (50.0–85.0), respectively. The highest and lowest mean (standard deviation) treatment satisfaction scores were for the convenience and safety satisfaction dimensions: 87.7 (17.9) and 53.1 (33.5), respectively. Unemployment, older age, previous hospital admission, non-adherence to lifestyle modification, and presence of three or more cardiovascular disease factors were significantly negatively associated with HRQoL.ConclusionsOverall, the study found that cardiovascular disease had a profound negative effect on HRQoL and patient treatment satisfaction. We suggest that interventions to enhance HRQoL and treatment satisfactions should focus on modifiable associated factors including lifestyle changes and controlling disease progression.

This survey aims to determine relevant patient characteristics, treatment satisfaction, and bothersome symptoms in Japanese patients with chronic constipation (CC) treated at medical institutions. Epidemiological surveys of Japanese patients with CC are limited. This internet survey, conducted in 2017, included 500 adults (selected from 589 respondents to match age composition ratio in Japan) who experienced constipation-like symptoms for ≥6 months, were treated at medical institutions for symptoms, and were taking any prescribed medication. Of 500 patients, 65.6% were female and 62.6% had experienced constipation for >10 years. Abdominal bloating, infrequent bowel movement, hard consistency of stool, and difficulty of defecation were the most frequently reported and most bothersome symptoms in males and females. Overall, 29% of patients were satisfied with treatment (36% of males, 26% of females); the individual major CC symptom with the highest level of treatment satisfaction was infrequent bowel movement (31% of total, 45% of males, 26% of females). The level of treatment satisfaction for most individual major CC symptoms was lower in females than in males, and overall treatment satisfaction by therapeutic categories ranged from 16% to 46%. Mean overall treatment satisfaction, as well as mean treatment satisfaction for each major symptom, decreased with increasing number of treatments. The survey results suggest that conventional treatment options were not effective enough to improve bothersome symptoms or treatment satisfaction. Treatment selection that is tailored to individual symptoms and takes patient characteristics into consideration may be key to improving patients' treatment satisfaction.

BackgroundAdherence and persistence are critical to optimising therapeutic benefit from disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS). This prospective, open-label, multicentre, observational study (AubPRO), conducted in 13 hospital-based neurology...

Validating the “Treatment Satisfaction Questionnaire for Medication” in Persian and Evaluating Treatment Satisfaction Among Patients With Psoriasis

ABSTRACTObjective: This study was designed to assess treatment satisfaction in patients using pramlintide who had not previously achieved glycemic targets with insulin therapy alone. Assessment included the association between treatment satisfaction and clinical outcomes (changes in post-prandial glucose [PPG], glycosylated hemoglobin [HbA1c], weight, and insulin requirements).Research design and methods: In this open-label study 240 participants with type 1 diabetes and 160 participants with type 2 diabetes added pramlintide to their established insulin regimen. Mealtime insulin doses were subsequently adjusted to optimize glycemic control.Main outcome measures: Seven-point glucose profiles, weight, and insulin requirements were obtained at baseline and months 1, 3, and 6; HbA1c levels were obtained at baseline and months 3 and 6. Participants completed a treatment satisfaction questionnaire (TSQ) at months 1, 3, and 6.Results: Participants rated the study treatment regimen including pramlintide significantly ( p < 0.001) superior to their pre-study regimens in terms of ‘glucose control’, ‘eating-weight control’, and ‘general benefits’ at all three TSQ administrations. Regression analysis of treatment satisfaction at 6 months revealed several independent predictors ( p < 0.05). Participants who were able to reach the maximum dosage of pramlintide per protocol, and those who experienced more reduction in PPG and insulin requirements during the study, reported higher satisfaction with glucose control and general benefits; those who lost more weight reported higher treatment satisfaction on all three TSQ measurements.Conclusions: Greater satisfaction with the study regimen was reported on all treatment satisfaction factors at all three TSQ administrations, with all advantages representing large treatment effects. Treatment satisfaction was higher for patients who experienced better clinical outcomes (decreases in weight, insulin dose requirements, and PPG levels). Study limitations include the fact this was an open-label study.

BackgroundTo assess quality of life and treatment satisfaction in patients with type 2 diabetes mellitus with diabetic retinopathy (DR) using validated instruments, with comparison to patients without DR.MethodsA prospective cross-sectional study was designed to assess the influence of retinopathy on quality of life and treatment satisfaction in patients with type 2 diabetes mellitus who do not have any other advanced late complications that could interfere with these outcomes. We included 148 patients with DR and 149 without DR, all without other advanced diabetic complications. Quality of life was assessed using the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire, and treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Clinical and treatment variables related to diabetes were also collected. The degree of DR was classified according to the International Clinical Classification System. Multivariate linear regression models were used to model the ADDQoL and DTSQ scores according to sociodemographical and clinical characteristics, and to model the adjusted relationship of DTSQ with ADDQoL. In DR patients, a subanalysis assessed the relationship of these scores with the degree of retinopathy, severity of macular edema, and previous photocoagulation treatment.ResultsDR was associated with significantly lower quality of life (p < 0.001), when examining the two general quality of life items and most of the specific domains. Concerning DTSQ, no difference was found in the total score, and only two domains that assess the perception of glycemic control (hyper- and hypoglycemia) showed a worse score in DR (p < 0.001 and p = 0.008, respectively). Quality of life was significantly affected by the severity of DR, and treatment satisfaction was significantly affected by the severity of macular edema. In the multivariate analysis, a significant effect of the interaction between diabetes duration, insulin therapy, and the presence of DR was found for both, ADDQoL and DTSQ.ConclusionIn the absence of other major complications, DR has a negative impact on quality of life in patients with type 2 diabetes. Further, treatment satisfaction was not affected by the presence of DR.