Treatment Patient Satisfaction Research Articles

Central sensitivity syndrome affects the disease activity index and treatment satisfaction in patients with rheumatoid arthritis.

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.

Efficacy and tolerability of half-yearly long acting injectable palmitate paliperidone after 12 months follow-up

IntroductionThis retrospective study analysed the clinical efficacy, tolerability and treatment satisfaction of patients who switched from receiving palmitate paliperidone monthly (PP1M) to palmitate paliperidone six-monthly (PP6M) after 12 months of follow-up. A total of 48 patients (31 men and 17 women) with recently diagnosed schizophrenia were included.ObjectivesTo assess the clinical efficacy, tolerability and treatment satisfaction in a sample of recently diagnosed schizophrenic patients who switched from receiving palmitate paliperidone monthly (PP1M) to palmitate paliperidone six-monthly (PP6M)MethodsThe sample included a total of 48 recently diagnosed schizophrenic (1-5 years) from three Mental Health units in the province of Toledo (Spain). The inclusion criteria were a diagnosis of schizophrenia (based on the ICD-10 criteria), the start of treatment with Long Acting Injectable Paliperidone Palmitate six-monthly (previously with palmitate paliperidone monthly), and the non-utilization of another neuroleptic treatment. A series of demographic variables were recorded, PANSS scale was used to to identify the presence and severity of psychopathology symptoms and the CGI scale was used to assessed the severity of the symptoms finally time to relapse was measured (primary outcome). The scales were again applied at baseline, 3 and 6 and 12 months after the start of treatmentResultsN=48 patients (31 males and 17 females), with a mean age of 31 years. 4.3 years of evolution of illness. During the follow-up period only 2 patients (4%) relapsed. Results showed an improvement in PANSS (baseline 50.8, 3 months 41.9, 6 months 37.3, 12 months 26.1), likewise and improvement in CGI was observed (baseline 4.1, 3 months 3.4, 6 months 2.9, 12 months 2.5).In terms of tolerability, no secundary effects were reported after treatment change, suggesting a good safety profile and predictable tolerability of PP6M. Patient satisfaction with treatment also improved over time. The study reports that 87% of patients accepted the switch from PP1M to PP6M, with reasons for switching including reduced frequency of administration and increased comfort. Most patients (95%) received antipsychotic monotherapy.ConclusionsIn conclusion, this study suggests that switching from PP1M to PP6M in patients with recently diagnosed schizophrenia was associated with maintained clinical stability, good tolerability and improved patient satisfaction with treatment. These findings support the efficacy and clinical utility of PP6M as a convenient and effective treatment option for patients with schizophrenia.Disclosure of InterestNone Declared

Facial Sentimental Analysis in Hospitals

Abstract: In today's rapidly evolving healthcare landscape,the focus on patient satisfaction and well-being has become crucial. A positive experience plays an important role in aiding the recovery of the patient. A significant factor contributing to a positive patient experience is the quality care and the emotionalsupport they receive during their hospital stay. Traditional methods of measuring patient satisfaction often rely on surveys and feedback forms, which can be subjective, time-consuming, and potentially biased. To address these limitations, this abstract proposes a novel approach: the integration of facial sentiment analysis as a real-time tool for assessing patient emotions and satisfaction levels. This abstract introduces an approach to enhance patient satisfaction and well-being in healthcare settings. By integrating facial sentiment analysis, we propose a realtime method to objectively evaluate patient emotions and treatment satisfaction. Through advanced computer vision, this approach detects and interprets facial expressions of patients inhospitals, offering insights into care effectiveness, dedication of hospital staff, and efficiency of the treatment. The system generates a "Happiness and Satisfaction Index," aiding healthcare stakeholders in making informed improvements as well and it works as a review metric for the customers who wouldlike to visit their hospital.

Adult self-reported childhood maltreatment types are associated with treatment satisfaction and alcohol relapse in patients with comorbid substance use and mental health disorders.

Individuals with comorbid substance use and mental health disorders (concurrent disorders; CD) report poor treatment outcomes, high prevalence of childhood maltreatment, and mostly negative experiences with treatment. No studies to date have examined childhood maltreatment and treatment outcomes in CD. This study investigated self-reported childhood maltreatment as it relates to treatment satisfaction and substance use relapse among CD patients. The 258 CD inpatients completed a self-report questionnaire package, comprising the Childhood Trauma Questionnaire and the Inpatient Consumer Survey (ICS). Childhood maltreatment was assessed according to five subtypes and self-perceived treatment satisfaction was rated across six ICS domains. Psychiatric diagnoses, substance use status and relapse data were retrieved via patient medical charts. Emotional neglect was associated with lower ratings across all ICS domains and physical neglect was associated with a lower rating for 'outcome of care'. Childhood sexual abuse was associated with a greater likelihood of alcohol relapse. No other relationships were statistically significant. The presence of childhood neglect (but not abuse) was more associated with overall treatment dissatisfaction, and sexual abuse alone increased the likelihood of alcohol relapse. These findings suggest some early adverse experiences in CD patients may increase negative experiences in treatment while others contribute to the risk of substance use. Broader longitudinal research is needed to examine the trajectory leading to negative outcomes. This is the first study to report differential patterns of association by type of childhood maltreatment on negative outcomes in treatment among CD patients.

A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol

BackgroundCannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD.Methods/DesignA phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment.Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled.Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment.DiscussionCurrent psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1–6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use.Trial registrationAustralian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).

Clinical affect of contralateral knee pain on patients undergoing total knee arthroplasty

To evaluate the effect of contralateral knee pain on joint dysfunction and treatment satisfaction on the operative side 1 year after total knee arthroplasty（TKA） in patients with osteoarthritis. From March 2019 to January 2021, 635 patients underwent TKA including 296 males and 339 females, with an average age of （69.33±9.38） years old, the duration of symptoms was （1.15±0.44） years. According to the degree of pain visual analogue scale（VAS） in the contralateral knee joint 12 months after operation, the patients were divided into three groups, 423 patients with no or mild pain（VAS 0 to 3）, 105 patients with moderate pain（VAS 4 to 6）, 107 patients with severe pain（VAS 7 to 10）. The related factors of knee function and satisfaction score 12 months after operation were analyzed and compared on different contralateral knee pain levels. The contralateral knee pain VAS was significantly reduced after TKA. Old age, high body mass index, high WOMAC scores of postoperative knee joint, moderate and severe pain of contralateral knee joint were the risk factors of dissatisfaction （P<0.05）, OR were 1.285, 1.665, 2.319, 1.863 respectively. The high degree of knee pain on the operation side and the ladder room in the home environment were the risk factors for the high WOMAC scores 1 year after discharge（P<0.05）. Adherence to exercise and functional training after discharge were the protective factors for patients with high WOMAC scores 1 year after discharge（P<0.05）, OR were 3.016, 1.738, 0.619, 0.574 respectively. TKA can alleviate the pain of contralateral knee joint. Contralateral knee pain does not affect the WOMAC scores after TKA, but it will reduce the treatment satisfaction of patients.

504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis

Abstract Introduction Formulating a topical medication that does not irritate the skin is an important factor contributing to patient treatment adherence and satisfaction. Many topical prescription products use penetration enhancers (including propylene glycol, polyethylene glycol, and ethanol) to overcome barrier properties of the skin. However, these excipients may irritate the skin causing tolerability reactions such as burning and stinging, which can reduce patient treatment adherence. Topical roflumilast is a highly potent (Kd∼0.7 nM) phosphodiesterase 4 inhibitor formulated as a water-based cream or foam that does not contain penetration enhancers or fragrances. Objectives We present prospectively assessed investigator- and patient-rated local tolerability from Phase 3 trials of topical roflumilast for patients with psoriasis (DERMIS-1, DERMIS-2, ARRECTOR) seborrheic dermatitis (SD; STRATUM), and atopic dermatitis (AD; INTEGUMENT-1, INTEGUMENT-2). Methods Patients were randomized to apply topical roflumilast (DERMIS: 0.3% cream; ARRECTOR and STRATUM: 0.3% foam; INTEGUMENT: 0.15% cream) or vehicle once daily for 8 weeks (DERMIS, ARRECTOR, and STRATUM) or 4 weeks (INTEGUMENT). Investigators assessed local tolerability on an 8-point scale (0 [no evidence of irritation] to 7 [strong reaction spreading beyond application site]) in the clinic before investigational product (IP) application. Patients reported local tolerability on a 4-point scale (0 [none: no sensation] to 3 [severe: hot, tingling/stinging sensation that has caused definite discomfort]) in the clinic 10-15 minutes after IP application. Tolerability was also assessed by reviewing documented adverse events. Results As assessed by investigators, ≥96.5% of patients in the roflumilast-treated groups had no evidence of irritation at the application site across all trials at all timepoints. Patient-rated local tolerability was favorable and improved with treatment: across all trials, 1% of roflumilast-treated patients reported a score of 3 (severe; defined as a “hot tingling/stinging sensation that has caused definite discomfort”) after the first application (day 1) and &amp;lt;1% at each subsequent assessment. Rates of adverse events, including those at the application site, were low for all trials. Conclusions Roflumilast cream and foam formulations demonstrated favorable local tolerability based on investigator- and patient-rated assessments in patients with psoriasis, SD, and AD, including application to sensitive areas such as the face and intertriginous areas. ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389; ARRECTOR: NCT05028582; STRATUM: NCT04973228; INTEGUMENT-1: NCT047​73587; INTEGUMENT-2: NCT04773600.

Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis

Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis&#x0D; &#x0D; Christopher G. Bunick1 on behalf of the authors&#x0D; &#x0D; INTRODUCTION: Formulating a topical medication that does not irritate the skin is an important factor contributing to patient treatment adherence and satisfaction. Many topical prescription products use penetration enhancers (including propylene glycol, polyethylene glycol, and ethanol) to overcome barrier properties of the skin. However, these excipients may irritate the skin causing tolerability reactions such as burning and stinging, which can reduce patient treatment adherence. Topical roflumilast is a highly potent (Kd~0.7 nM) phosphodiesterase 4 inhibitor formulated as a water-based cream or foam that does not contain penetration enhancers or fragrances. We present prospectively assessed investigator- and patient-rated local tolerability from Phase 3 trials of topical roflumilast for patients with psoriasis (DERMIS-1, DERMIS-2, ARRECTOR) seborrheic dermatitis (SD; STRATUM), and atopic dermatitis (AD; INTEGUMENT-1, INTEGUMENT-2).&#x0D; METHODS: Patients were randomized to apply topical roflumilast (DERMIS: 0.3% cream; ARRECTOR and STRATUM: 0.3% foam; INTEGUMENT: 0.15% cream) or vehicle once daily for 8 weeks (DERMIS, ARRECTOR, and STRATUM) or 4 weeks (INTEGUMENT). Investigators assessed local tolerability on an 8-point scale (0 [no evidence of irritation] to 7 [strong reaction spreading beyond application site]) in the clinic before investigational product (IP) application. Patients reported local tolerability on a 4-point scale (0 [none: no sensation] to 3 [severe: hot, tingling/stinging sensation that has caused definite discomfort]) in the clinic 10-15 minutes after IP application. Tolerability was also assessed by reviewing documented adverse events.&#x0D; RESULTS: As assessed by investigators, ≥96.5% of patients in the roflumilast-treated groups had no evidence of irritation at the application site across all trials at all timepoints. Patient-rated local tolerability was favorable and improved with treatment: across all trials, 1% of roflumilast-treated patients reported a score of 3 (severe; defined as a “hot tingling/stinging sensation that has caused definite discomfort”) after the first application (day 1) and &lt;1% at each subsequent assessment. Rates of adverse events, including those at the application site, were low for all trials and &lt;0.5% of roflumilast-treated patients discontinued due to adverse events at the application site across all trials.&#x0D; CONCLUSION: Roflumilast cream and foam formulations demonstrated favorable local tolerability based on investigator- and patient-rated assessments in patients with psoriasis, SD, and AD, including application to sensitive areas such as the face and intertriginous areas.&#x0D; Sponsored by Arcutis Biotherapeutics, Inc.&#x0D; ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389; ARRECTOR: NCT05028582; STRATUM: NCT04973228; INTEGUMENT-1: NCT04773587; INTEGUMENT-2: NCT04773600

Direct discharge for children with a greenstick or torus fracture of the wrist is a non-inferior satisfactory solution to traditional treatment.

Direct Discharge protocols (DD) can alleviate strain on healthcare systems by reducing routine outpatient follow-up. These protocols include low-complex musculoskeletal injuries, such as isolated greenstick fractures or torus fractures of the wrist in children. While there is consensus on the effectiveness of DD, there is a lack of injury-specific powered studies. This study compares treatment satisfaction between DD and traditional treatment in children with a greenstick fracture or torus fractures of the wrist. Children with isolated torus or greenstick fractures of the distal radius or ulna were eligible for inclusion before (pre-DD cohort) and after (DD cohort) the implementation of DD in four hospitals. Traditionally, patients receive a (soft) cast and minimally one routine outpatient follow-up appointment. With DD, patients are discharged directly from the ED after receiving a brace and information, summarized in a smartphone app and a helpline for questions during recovery. The primary outcome was patient or proxy treatment satisfaction (0 to 10), and a power analysis was performed to assess non-inferiority. Secondary outcomes included complications, functional outcomes measured in Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS UE), primary healthcare utilisation, and secondary healthcare utilisation (follow-up appointments and imaging). In total, 274 consecutive children were included to analyse the primary endpoint. Of these, 160 (58%) were male with a median age of 11years (IQR 8 to 12). Pre-DD and DD treatment satisfaction did not vary statistically significantly for greenstick fractures (p = 0.09) and torus fractures (p = 0.93). No complications were observed. PROMIS UE showed no statistically significant differences before and after implementation of direct discharge protocol for torus (p = 0.99) or greenstick (p = 0.45) fractures. Secondary healthcare utilisation regarding follow-up was significantly lower in the DD-torus cohort compared to the pre-DD torus cohort, with a mean difference (MD) of -1.00 follow-up appointments (95% Confidence Interval (CI) -0.92 to -1.13). Similar results were found in the pre DD-greenstick cohort compared to the pre-DD-greenstick cohort (MD): -1.17 follow-up appointments, 95% CI -1.09 to -1.26). Direct Discharge is non-inferior to traditional treatment in terms of treatment satisfaction for paediatric patients with greenstick or torus fractures of the wrist compared to children treated with rigid immobilisation and routine follow-up. Furthermore, the results demonstrate no complications, comparable functional outcomes, and a statistically significant reduction of secondary healthcare utilisation, making DD a good solution to cope with strained resources for children with an isolated greenstick fracture or torus fracture of the wrist.

The Impact of Diabetes Education by Clinical Pharmacist on Quality of Life and Treatment Satisfaction of Sudanese Individuals With Type II Diabetes Mellitus: Randomized, Double-Blind, Controlled Trial.

Patients' satisfaction with their treatment directly impacts the control of their diabetes. Quality of life is crucial for patients with diabetes mellitus to maintain long-term health and minimize complications. The current study aimed to evaluate the impact of diabetes education on quality of life (QoL) and treatment satisfaction of patients with type 2 diabetes mellitus. The current study was a randomized controlled trial. Patients with type 2 diabetes who were attending the diabetes clinic for 1 year were recruited. The overall sample in this study was 364 participants; 182 controls 182 cases. The interventional and control group participants were assigned randomly by simple random sampling technique. Controls were managed per usual care while cases were managed per usual care plus education done by the researcher. Pre-structured standardized questionnaires were used to collect the data. Data were processed and analyzed by using SPSS; version 28. More than three-fourth of the participants; 76.4% were females. The average (±SD) age of the cases was 54.5 (±10) years, while was 56 (±9.8) years for controls. The overall median (IQR) years of DM diagnosis for all participants was 8 (4-14) years. The results showed a statistically significant difference between the mean satisfaction score from baseline to 12 months in the cases compared the controls (P < .001). Furthermore, there are statistically insignificant differences between the changes of mean overall QoL score from baseline to 12 months among the 2 groups. The education provided improved self-reported treatment-satisfaction among individuals with diabetes .A statistically insignificant differences in QoL between the 2 groups compared to baseline have been shown at the study end.The trial registration number is PACTR202311766174946 which was registered by pan African clinical trials registry, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=26928.

Factors Associated with Treatment Satisfaction in Korean Patients with Psoriasis.

Treatment satisfaction among patients with psoriasis can vary significantly based on available treatment options and individual patient characteristics. This cross-sectional study utilized psoriasis-specific questionnaires to assess treatment satisfaction and identify the factors associated with treatment satisfaction in Korean patients. The study included 350 eligible patients aged 19 or older from a nationwide psoriasis group. Participants completed a self-reported web-based questionnaire assessing socioeconomic and clinical status, quality of life, and treatment satisfaction. Linear regression models were employed to analyze the factors associated with treatment satisfaction. The results showed that patients with mild to moderate psoriasis, as determined by the body surface area involvement, had higher satisfaction scores for treatment effectiveness. Moreover, patients receiving biologic therapies reported significantly higher total satisfaction scores and scores across all domains than those not utilizing biologics. However, patients reporting poorer quality of life or experiencing anxiety exhibited lower satisfaction scores. Findings suggest that while biologic treatments may confer greater satisfaction to patients with psoriasis, diminished quality of life and anxiety can negatively impact satisfaction levels. The study underscores the importance of understanding the factors associated with patient satisfaction to optimize treatment outcomes in psoriasis management.

Treatment access and satisfaction on disease-modifying therapies of neuromyelitis optica spectrum disorder patients in China: a cross-sectional survey.

Neuromyelitis optica spectrum disorder (NMOSD) is a rare and debilitating disease that has become more widely recognized in China. Legislative measures have been implemented by the government to improve treatment access for rare diseases. To investigate the diagnostic journey, treatment status, treatment accessibility, and treatment satisfaction of the NMOSD patients on disease-modifying therapies (DMTs) in China. A patient online survey. This cross-sectional online survey was conducted between November 2022 and January 2023. Patients over 18 years old and diagnosed with NMOSD were included. The questionnaire consisted of five sections covering demographics, diagnostic and treatment experiences, DMTs availability, cost and affordability, and treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (version II). Patient opinions and demands were also collected at the end of the survey. A total of 375 patients diagnosed with NMOSD were recruited, of which 321 patients used DMTs. It required 1.22 ± 3.22 years and 3.58 ± 4.24 hospital visits for a definitive diagnosis. One-third of the patients still needed to travel for over 2 h to access DMTs. The total treatment expenditure was estimated to be CNY 59,827.00 (USD 8315.95) a year. Drug expenses alone accounted for 52.22% of the average annual household income. The most common challenges perceived were the inability to afford treatment and a lack of effective options. No significant difference was found in treatment satisfaction among DMTs, except that rituximab scored lowest in convenience compared to other DMTs. Patients' age and travel time required to obtain medications were negatively associated with global treatment satisfaction. In China, patients with NMOSD face challenges in obtaining proper treatment due to diagnostic difficulties, distant medication access, and high costs. Policies should prioritize improving disease education and alleviating financial burdens for the patients.

Prevalence and patterns of laxative use in subjects with self-reported constipation: results from a multinational digestive health survey.

Constipation is characterized by symptoms of straining, hard stool, difficult evacuation, and infrequent bowel movements. Online surveys provide valuable information about patients' perspectives, symptoms, management, treatment satisfaction, and risk factors. This survey explored subject experiences involving 20 gastrointestinal (GI) conditions. In total, 20,099 respondents in seven countries with varied cultural and socioeconomic backgrounds participated. Post hoc analysis of 'self-reported constipation' and related symptoms experienced within the past 6 months and the last episode of constipation provided data on prevalence, demographics, frequency and duration of episodes and related symptoms, impact on quality of life (QoL), management with or without laxatives, and resulting treatment satisfaction. In total, 10,425 subjects reported constipation within 6 months and 2637 at the last episode. Prevalence was highest in females and younger adults. Most subjects reported various coexisting GI symptoms. Almost 80% of 6865 episodes reported by 5337 subjects occurred every 2-3 months to every 2-3 weeks. A higher frequency of constipation correlated with a greater impact on QoL. On a 10-point scale, the mean impact was 6.4. More than 90% of respondents had episodes ranging from 1 day to 1 week. More than 90% took action; 16% used laxatives, of whom 80.3% were satisfied. Constipation, a highly prevalent disorder, spans cultures and socioeconomic classes. Its chronic recurrence has a significant impact on QoL, resulting in symptom self-management in >90% of subjects. Significantly higher satisfaction rates in subjects treated with than without laxatives reflect subjects' reports that self-reported constipation can be treated effectively with laxatives.

Study design of the VenaSeal Spectrum Program: Two randomized controlled trials and one single-arm prospective study of a cyanoacrylate closure system to treat early to advanced chronic venous disease

Background/ObjectiveChronic venous disease (CVD) affects >25% of adults in developed countries. It is usually a progressive disease; if left untreated, can lead to advanced disease such as venous ulceration. The VenaSeal Spectrum Program compares the VenaSeal closure system (VenaSeal) to the global standards of care for CVD: endothermal ablation and surgical stripping. It also investigates VenaSeal's usefulness for patients with venous leg ulcers (VLUs). A key component of this clinical program was to measure and quantify patient satisfaction with treatments related to discomfort, healing time, and effectiveness, which often has been overlooked in CVD research. This article describes the rationale and design of the VenaSeal Spectrum Program for patients with CVD. MethodsVenaSeal Spectrum is a prospective, postmarket, clinical trial program reporting outcomes from the periprocedural period through 5 years after treatment with VenaSeal. VenaSeal Spectrum has enrolled 506 participants at 32 sites in 10 countries requiring treatment for symptomatic Clinical, Etiological, Anatomical, and Pathophysiological Classification (CEAP) 2-6 CVD involving the truncal saphenous vein(s). The program is composed of three studies. Two randomized controlled trials compare VenaSeal ablation with either surgical stripping or endovenous thermal ablation in patients with symptomatic CEAP 2-5 disease. A single-arm prospective study investigates participants with active VLUs (CEAP 6) treated with VenaSeal. The unique primary end points for both randomized trials include both periprocedural and postprocedural patient treatment satisfaction measured by a new questionnaire (VenousTSQ) at 30 days post procedure and elimination of clinically relevant superficial truncal reflux in the target vein at index procedure. The primary end point for the VLU study is time to ulcer healing through 12 months. Secondary end points, which are more familiar to clinicians in this disease space, include time to return to work, complication rates, patient-reported outcome measures, and closure rates. ConclusionsVenaSeal Spectrum is a rigorously designed clinical study program with a large study population and unique patient-centric end points after treatment with VenaSeal for early to advanced symptomatic CVD. The studies report on the safety, effectiveness, and patient experience outcomes including two new primary end points assessing the specific needs of patients with venous insufficiency from the periprocedural period through 5-year follow-up.

Disease burden and treatment satisfaction in patients with prurigo nodularis in Japan.

Prurigo nodularis (PN) is a chronic inflammatory skin disorder with a high disease burden. In this cross-sectional, web-based survey, Global Questions (GQ), the Numerical Rating Scales (NRS) for pruritus, burning sensation and sleep disturbance, the Short-Form-8 (SF-8) Health Survey, Dermatology Life Quality Index (DLQI), Patient Health Questionnaire 9 (PHQ-9), Work Productivity and Activity Impairment (WPAI), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) scores were used to assess the current disease burden and treatment satisfaction among patients with PN in Japan. In total, 97 patients were included (55.7% male, median age 51 years, median duration of PN 36 months). Based on GQ scores, 35.1% of patients had mild disease, 50.5% moderate, and 14.4% severe disease. Disease burden increased as the severity of PN increased, as indicated by worsening of pruritus NRS scores and quality of life (DLQI, PHQ-9, WPAI presenteeism, work productivity loss, and activity impairment scores). Patients with comorbid atopic dermatitis (AD) also had more intense pruritus than those without AD. Mean ± standard deviation TSQM-9 scores for effectiveness, convenience, and global satisfaction were 54.7 ± 18.1%, 62.4 ± 15.2%, and 57.4 ± 15.9%, respectively. TSQM-9 scores were lowest in patients receiving the most intensive guideline-directed treatment (i.e., topical corticosteroids + systemic oral corticosteroids or cyclosporine), highlighting an unmet need for more effective treatment options for patients with PN. In summary, Japanese patients with PN reported increased disease burden and reduced treatment satisfaction with increased disease severity, despite the use of guideline-recommended therapies.

Feasibility of preemptive pharmacogenetic testing and improvement of medication treatment satisfaction among medically underserved patients.

Previous findings suggest that medically underserved patients are prescribed medications with pharmacogenetic (PGx) guidelines at a high frequency. Thus, underserved patients may especially benefit from PGx testing, but little evidence exists regarding the effect of testing in this population. This pilot study aimed to generate key feasibility data and explore clinical outcomes of PGx implementation in underserved populations. Black and Latino patients were recruited from an outpatient clinic and underwent PGx testing. Feasibility measures included enrollment metrics and actionable genotype frequencies. The primary clinical outcome was patient medication treatment satisfaction 6 months after testing. Implementation outcomes included the number of healthcare provider encounters and medication changes within the 6-month follow-up. Effectiveness outcomes included medication adherence, patient-perceived test value, and time spent discussing medications with providers. Ninety-nine patients completed the study. Proton-pump inhibitors were the most frequent PGx drug class prescribed at baseline (61%) followed by nonsteroidal anti-inflammatory drugs (36%). Patients with an actionable genotype constituted 96% of the population, whereas 28% had an actionable genotype related to their PGx drug. Patient treatment satisfaction significantly increased over the 6 months after PGx testing. In addition, medication adherence and the number of provider encounters significantly increased over the study period. In a pilot study, preemptive PGx testing was feasible in primary care clinics, improved patient treatment satisfaction and adherence, and increased the number of provider encounters in medically underserved patients. Future clinical trials are warranted to assess the long-term effects of PGx testing in a larger diverse patient population.

Effects of 6-Month Treatment with Dimethyl Fumarate (DMF) on Treatment Satisfaction and Work Improvement in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (Interim Data Analysis)

Effects of 6-Month Treatment with Dimethyl Fumarate (DMF) on Treatment Satisfaction and Work Improvement in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (Interim Data Analysis)

Interim Analysis of Treatment Satisfaction from a Prospective Phase 4 Study in Adult Immune Thrombocytopenia (ITP) Subjects after Switching from Eltrombopag or Romiplostim to Avatrombopag

Background: Recently, the Thrombopoietin-Receptor Agonist (TPO-RA) Patient experience survey (TRAPeze) determined that the characteristics which influence preference towards TPO-RA treatments the most were the method of administration and drug-food interactions. Specifically, participants were more likely to select an oral tablet over a subcutaneous injection and a treatment without food restrictions rather than one with food restrictions (McDonald V, et al, 2021). A majority of patients in a real-world analysis who switched from eltrombopag (ELT) or romiplostim (ROMI) to avatrombopag (AVA) did so due to perceived convenience benefits (Al-Samkari H, et al, 2022). The ongoing AVA-ITP-401 prospective interventional study is evaluating treatment satisfaction and on-therapy convenience in patients immediately switching to AVA from either ELT or ROMI and aims to provide valuable patient-reported outcomes. Safety and platelet count (PC) response to AVA following a switch from the other two TPO-RAs are also being evaluated. In a separate abstract submission, the mean/median PCs are reported to either be improved or maintained with AVA treatment over 90 days. Methods: This is an interim analysis of a prospective, multi-center, open-label Phase 4 study being conducted in the US (NCT04638829) since March 2021. Subjects who have been receiving ELT or ROMI for ≥90 days prior to study entry are enrolled and immediately switched to AVA at a starting dose of 20 mg daily. Key inclusion criteria: age ≥18 years; subjects have been undergoing treatment for primary ITP with ELT or ROMI for ≥90 days prior to the screening visit; subjects have had a previous response to either ELT or ROMI. The primary endpoint is occurrence of adverse events and serious adverse events. A key secondary endpoint is the change from baseline in each of the 4 domains of the self-administered Treatment Satisfaction Medication Questionnaire (TSQM) Version 1.4 (convenience, global satisfaction, effectiveness, and side effects) to Day 90 (D90) or End of Study (EOS). An increase in domain mean score indicates an increased patient preference to a given therapy in that domain. Clinic Visits were mandated per protocol at Days 15 (D15), 30 (D30), 60 (D60), and 90/End of Study (D90/EOS) with PCs obtained at each timepoint. The TSQM was assessed at baseline (BL), D30, and D90/EOS. Results: As of April 1, 2023, 51 patients were screened with 47 enrolled. 35 completed the study, 3 dropped out, and 6 are on-going. The mean age at enrollment was 58 years, the median (min,max) time since ITP diagnosis was 2.88 years (0.2,31.0), 60% were female, 72% were Caucasian, and 11% had a previous history of splenectomy. 62% of patients were switched to AVA from ELT (median prior treatment duration 42 weeks (range 12 - 442); median daily dose 50 mg) and 38% from ROMI (median prior treatment duration 81 weeks (range 12 - 468); median weekly dose ≤3 µg). Safety results will be reported when the study is complete. TSQM individual domain BL, D30, and D90/EOS mean values and mean percent change from BL following the switch from either ELT or ROMI to AVA are summarized in Table 1. In the Total Population, scores at BL in all four domains were generally high reflecting patient satisfaction to their prior therapy. Following the switch to AVA, however, there was measurable improvement in satisfaction across all domains-most pronounced in the effectiveness, convenience, and global satisfaction domains. This improvement began at D30 and was maintained through D90/EOS. The increase in patient-reported satisfaction was greater in ELT-switchers than with ROMI-switchers; however, improvement in satisfaction was observed by EOS across all four domains in the ROMI-switching population as well. Summary/Conclusion: Despite high patient satisfaction scores at BL from prior therapy (ELT or ROMI), patients reported higher satisfaction following a switch to AVA across all domains of the TSQM (effectiveness, side effects, convenience, and global satisfaction) over 90 days. In a population of patients who were generally responding to TPO-RAs prior to a switch to AVA, mean/median PCs were also either improved or maintained with AVA treatment for the duration of the study (reported in a separate abstract submission), suggesting that some patients may experience sustained effectiveness paired with enhanced overall treatment satisfaction when switching from ELT or ROMI.

Hereditary angioedema outcomes in US patients switched from injectable long-term prophylactic medication to oral berotralstat

BackgroundBerotralstat, a first-line, once-daily, oral plasma kallikrein inhibitor for long-term prophylaxis of hereditary angioedema (HAE), is an effective and well-tolerated treatment option. ObjectiveTo summarize the safety, effectiveness, and impact on treatment satisfaction in patients who switched from injectable long-term prophylactics to oral berotralstat monotherapy (150 mg daily) at US sites in the international open-label APeX-S study. MethodsAPeX-S was an open-label, Phase II study of berotralstat conducted in 22 countries. Here, we focus on APeX-S patients enrolled at US sites who switched from injectable long-term prophylactics to berotralstat 150 mg once-daily monotherapy. ResultsA total of 34 patients discontinued lanadelumab (n = 21), subcutaneous C1 esterase inhibitor (n = 11), or intravenous C1 esterase inhibitor (n = 2) and switched to berotralstat 150 mg monotherapy. Vomiting, diarrhea, and upper respiratory tract infection were the most common adverse events (each 11.8%). Mean monthly attack rates were consistently low after the switch to berotralstat. The mean (SEM) monthly attack rate was 0.29 (0.11) at Month 1, 0.48 (0.15) at Month 6, and 0.58 (0.23) at Month 12. The median attack rate was 0 attack/mo throughout 12 months of treatment. Improvements were observed in the Treatment Satisfaction Questionnaire for Medication from baseline to Month 12 after the switch to berotralstat monotherapy, with the greatest improvements in convenience. ConclusionThe transition from injectable prophylactic medication to berotralstat was generally well tolerated. Patients switching to berotralstat monotherapy maintained good control of their HAE symptoms and reported improved treatment satisfaction. Trial RegistrationClinicalTrials.gov Identifier: NCT03472040.

Does Inpatient Equivalent Home Treatment lead to higher satisfaction? Results on satisfaction of persons involved in treatment within the Multi-center AKtiV Study

This part of the AKtiV Study focuses on treatment satisfaction of patients and their relatives within Inpatient Equivalent Home Treatment (IEHT) and regular treatment. Stress of relatives and job satisfaction and workload of employees in IEHT is also considered. Relevant Parameters were collected via established as well as newly adapted questionnaires at the end of treatment. Patients and relatives in IEHT are significantly more satisfied. The stress experienced by relatives is reduced in both forms of treatment. Employees in IEHT are generally very satisfied, although there is no correlation with the satisfaction of relatives and patients. Known limitations of satisfaction surveys must be taken into account. In general these results encourage the expansion and continuous development of this new form of treatment in Germany.