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Stephanie D Taylor,1 Sharlette V Everett,1 Thomas N Taylor,2 Douglas J Watson,3 Gavin Taylor-Stokes4 1Global Health Outcomes, Merck Sharp and Dohme Corp, Whitehouse Station, NJ, USA; 2Pharmacy Practice, Wayne State University, Detroit, MI, USA; 3Epidemiology, Merck Sharp and Dohme Corp, Upper Gwynedd, PA, USA; 4Adelphi Real World, Macclesfield, UK Purpose: The clinical response to traditional nonsteroidal anti-inflammatory drugs (tNSAIDs) varies substantially. The objective of this study was to describe physicians’ and patients’ perceptions of response to tNSAIDs as measured by satisfaction with control of patients’ osteoarthritis (OA). Patients and methods: A cross-sectional survey was undertaken in 2009 in Germany, Spain, and the UK. Linked physician and patient questionnaires collected data on OA management, degree of pain and disability, and satisfaction with OA control. Results: The study included 363 treating physicians and 713 patients receiving tNSAIDs. Patient mean (standard deviation) age was 65.5 (11.0) years (range 36–94 years); 60% were women; 86% were white; and one-quarter were obese. Dissatisfaction with control of patients’ OA was expressed by physicians or their patients, or both, for 51% of patients, including 208 patients (31%) with mild OA and 478 patients (60%) with moderate or severe OA. Overall, 37% of patients reported dissatisfaction and 34% had a physician who reported dissatisfaction. Patient and physician assessments were the same in 70% of cases; Cohen’s κ coefficient was 0.34 (95% confidence interval 0.26–0.41), indicating fair agreement. Of those reporting dissatisfaction, most physicians (79%) and patients (64%) believed that the current control was the best that could be achieved. The most common reasons for which physicians reported dissatisfaction were inadequate response (56%), side effects (11.1%), and poor tolerance (7.8%). Conclusion: One-half of patients or their treating physicians were dissatisfied with the control of OA provided by tNSAID therapy; moreover, most believed it was the best control that could be achieved. Keywords: cross-sectional, dissatisfaction, pain, survey

Gavin Taylor-Stokes1, James Pike1, Alesia Sadosky2, Arthi Chandran2, Thomas Toelle31Adelphi Real World, Adelphi Mill, Bollington, Macclesfield, Cheshire, UK; 2Pfizer Inc, New York, NY, USA; 3Department of Neurology, Technische Universität München, Munich, GermanyObjective: To evaluate the association of patient-reported severity of painful diabetic peripheral neuropathy (pDPN) with other outcomes in a European population of patients using the Adelphi Disease Specific Programme for pDPN (DSP III, 2008).Methods: The severity of patients' pDPN (mild, moderate, or severe) was rated independently by both patients and physicians. Relationships were evaluated between patient-reported pDPN severity and other patient-reported outcomes including pain, sleep, function, and work productivity. Physicians rated the severity of patients’ pDPN (1 = mild, 2 = moderate, 3 = severe) and sleep interference.Results: Patient-reported data were available from 634 individuals (56.2% male, mean age 63 years) from France, Germany, Italy, and the UK, of whom only 22.2% reported that they were currently employed. pDPN severity was rated as mild, moderate, and severe by 22.2%, 60.9%, and 16.9% of the patients, respectively. There was a significant association between patient-rated and physician-rated pDPN severity (P < 0.0001), although there were discrepancies in agreement (kappa = 0.37, 95% confidence interval [CI] 0.31, 0.43; weighted kappa = 0.43, 95% CI 0.37, 0.48) among physician and patient ratings in a substantial proportion of patients across severity categories. Higher pDPN severity was associated with greater interference of daily function including sleep (P < 0.0001 for all pairwise comparisons). Among employed patients, percent of pDPN-related impairment while at work (presenteeism) and overall work impairment increased with greater pDPN severity, resulting in indirect costs that increased significantly with pDPN severity; $8266, $15,449, and $24,300 for mild, moderate, and severe pDPN, respectively (overall P < 0.001).Conclusion: Severity of patient-rated pDPN was significantly associated with outcomes, including function and productivity; poorer function and lower productivity were reported at higher pDPN severity levels. Moreover, physicians rated pDPN severity different from patients in a substantial proportion of patients.Keywords: diabetic neuropathy, pain, outcomes

Le raltegravir 1200 mg une fois par jour (RAL 1200 QD) est disponible en Angleterre depuis septembre 2017. Cette étude est la première à décrire la population dans laquelle RAL 1200 QD est prescrit en en vie réelle. Les objectifs primaires de l'étude sont la description démographique des patients, de leurs caractéristiques cliniques et thérapeutiques à l'inclusion. Les traitements antirétroviraux (ART) initiés avec RAL 1200 QD sont également analysés. Les données ont été collectées rétrospectivement avec un formulaire standardisé à partir des dossiers de 300 patients utilisant au moins une dose de RAL 1200 QD depuis sa mise à disposition et ayant eu une consultation de suivi à 6 mois (intervalle autorisé entre 5 et 9 mois) à Londres ou à Manchester. Sur les 300 sujets inclus, 255 (85 %) étaient des hommes, dont 182/255 (71 %) ayant des rapports sexuels avec des hommes, 56 % étaient caucasiens. L'âge médian au diagnostic et celui à l'initiation de RAL 1200 QD étaient 34 ans (18–86) et 45 ans (21–96) respectivement. Cinquante-six (19 %) étaient utilisateurs de substances récréatives, dont 5 (9 %) rapportant une pratique de chemsex. Deux cent quatre-vingt-cinq avaient déjà utilisé un ART (ART-E) et 15 étaient naïfs de traitement (TN). La charge virale (CV) à l'inclusion (BL) et le taux de CD4+ étaient disponibles pour 283 et 248 sujets ART-E respectivement ; 94 % avaient une CV à BL < 50 c/mL, et 96 % < 200 c/mL. Cinq pour cent des sujets ART-E avaient un taux de CD4+ ≤ 200 vs 20 % pour les TN. À BL, 60 % recevaient un traitement non-ART et 68 % avaient des comorbidités, les plus fréquentes étant une hyperlipidémie, une dépression, et une hypertension chez 68 (23 %), 56 (19 %) et 51 (17 %) sujets respectivement. Deux cent cinq (68 %) ont initié un traitement par TDF/FTC et 46 (15 %) par ABC/3TC. Quatre sur 267 (1 %) ayant une CV à BL < 50 c/mL, et 10/300 (3 %) des sujets ayant initié un traitement par RAL 1200 QD avaient une CV > 50 c/mL à la visite de suivi. À 6 mois, 21 (7 %) avaient arrêté RAL 1200 QD. En vie réelle, les patients initiant un traitement par RAL 1200 QD sont comparables aux populations des essais cliniques : ce sont majoritairement des HSH caucasiens. Cependant, ils débutent le traitement à un âge plus avancé, ont un fardeau de la maladie plus important, avec des comorbidités significatives et des co-médications importantes. Les arrêts de traitement et les mesures de la CV se situent dans les objectifs ONUSIDA 90 :90 :90. [ABSTRACT FROM AUTHOR]

Purpose: Malignant pleural mesothelioma (MPM) is an aggressive cancer with long latency and poor prognosis. The real-world treatment patterns and humanistic burden of MPM in an international cohort of patients were recently published. Spanish data are currently lacking and are reported here., Methods/patients: Data were collected from three sources: physician-abstracted demographic, clinical and treatment characteristics of patients with MPM; patient-completed questionnaires on treatment satisfaction, symptoms, caregiver use, and impact of the disease; and caregiver-completed questionnaire reporting their activity and its impact on their daily life., Results: The 241 patients in Spain were primarily elderly (median age: 67 years), male, retired/unemployed/on long-term sick leave, and diagnosed at stage IV with unresectable disease. Exposure to asbestos was detected (54%, 101/188). First-line treatment (1L) consisted primarily of doublet chemotherapy (86%, 207/241). Of 102 patients who completed 1L at data abstraction, 67 were receiving maintenance therapy, most commonly singlet chemotherapy with pemetrexed. Best supportive care was given to 29 patients, primarily after 1L (86.2%, 25/29). Symptom burden was high and health-related quality of life was poor and declined with progression: mean (SD) EQ-5D score and EQ-5D visual analogue scale score were 0.615 (0.285) and 60.8 (17.1) in 1L and 0.497 (0.370) and 56.1 (19.5) in second line. Overall, 67% of patients (162/241) required daily assistance from their caregiver, who reported an impact on their psychological well-being., Conclusions: Patients with MPM in Spain were overall treated according to treatment guidelines at the time. Nevertheless, a considerable burden of disease was reported by patients and caregivers., (© 2024. The Author(s).)

Purpose: There are limited data on the impact of caregiving for patients with malignant pleural mesothelioma (MPM) on the caregiver. We aimed to identify the demographic characteristics of these caregivers, the caregiving activities they perform and how caregiving burden impacts their work productivity and overall activity., Methods: This cross-sectional study collected data from caregivers of patients with MPM across France, Italy, Spain and the United Kingdom January-June 2019. Caregiver demographics, daily caregiving tasks and the impact of caregiving on physical health was collected via questionnaire. The Zarit Burden Interview (ZBI) was used to assess caregiver burden and the Work Productivity and Activity Impairment questionnaire (WPAI) assessed impairment at work and during daily activities. Analyses were descriptive., Results: Overall, 291 caregivers provided data. Caregivers were mostly female (83%), living with the patient (82%) and their partner/spouse (71%). Caregivers provided over five hours of daily emotional/physical support to patients. ZBI scores indicated 74% of caregivers were at risk of developing depression. Employed caregivers had missed 12% of work in the past seven days, with considerable presenteeism (25%) and overall work impairment (33%) observed. Overall, the mean activity impairment was 40%., Conclusion: Caregivers provide essential care for those with MPM. We show caregiving for patients with MPM involves a range of burdensome tasks that impact caregivers' emotional health and work reflected in ZBI and WPAI scores. Innovations in the management of MPM must account for how caregivers may be impacted and can be supported to carry out this important role., (© 2023. The Author(s).)

Objective: We aimed to investigate the burden of persistent musculoskeletal (MSK) pain in Rolls-Royce UK employees., Methods: Employees with ( n = 298) and without ( n = 329) persistent MSK pain completed a cross-sectional survey. Weighted regression analyses were conducted to compare sickness absence, work ability, workplace accommodations/adaptations, and emotional well-being between these cohorts, controlling for confounders., Results: Persistent MSK pain (particularly back pain) had a significant impact on physical work ability and was associated with increased sickness absence due to pain. Many employees (56%) had not disclosed their condition to their managers. Of these, 30% felt uncomfortable doing so, and 19% of employees reported insufficient support at work for their pain., Conclusions: These findings highlight the importance of creating a workplace culture that encourages the disclosure of work-relevant pain, enabling organizations to consider improved, tailored support for employees., Competing Interests: Conflict of interest: L.A., R.R., and L.S.-R. are employees of Pfizer with stock and/or stock options. G.T.-S., L.M., and H.W. are employees of Adelphi Real World who are paid consultants to Pfizer in connection with this study. D.R. was an employee of and holds stock and/or stock options in Rolls-Royce. K.G. is an employee of and holds stock and/or stock options in Rolls-Royce. K.B. is an employee of the University of Huddersfield and is paid by Pfizer for his duties on the STAMPP Steering Committee., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American College of Occupational and Environmental Medicine.)

Background: Uncomplicated urinary tract infections (uUTIs/acute cystitis) are among the most common infections in women worldwide. There are differences in uUTI treatment guidelines between countries and understanding the needs of physicians in diverse healthcare systems is important for developing new treatments. We performed a survey of physicians in the United States (US) and Germany to understand their perceptions of, and management approaches to uUTI., Methods: This was a cross-sectional online survey of physicians in the US and Germany who were actively treating patients with uUTI (≥ 10 patients/month). Physicians were recruited via a specialist panel and the survey was piloted with 2 physicians (1 US, 1 Germany) prior to study commencement. Data were analyzed with descriptive statistics., Results: A total of 300 physicians were surveyed (n = 200 US, n = 100 Germany). Across countries and specialties, physicians estimated 16-43% of patients did not receive complete relief from initial therapy and 33-37% had recurrent infections. Urine culture and susceptibility testing was more common in the US and among urologists. The most commonly selected first-line therapy was trimethoprim-sulfamethoxazole in the US (76%) and fosfomycin in Germany (61%). Ciprofloxacin was the most selected following multiple treatment failures (51% US, 45% Germany). Overall, 35% of US and 45% of German physicians agreed with the statement "I feel there is a good selection of treatment options" and ≥ 50% felt that current treatments provided good symptom relief. More than 90% of physicians included symptom relief amongst their top 3 treatment goals. The overall impact of symptoms on patients' lives was rated "a great deal" by 51% of US and 38% of German physicians, increasing with each treatment failure. Most physicians (> 80%) agreed that antimicrobial resistance (AMR) is serious, but fewer (56% US, 46% Germany) had a high level of confidence in their knowledge of AMR., Conclusions: Treatment goals for uUTI were similar in the US and Germany, although with nuances to disease management approaches. Physicians recognized that treatment failures have a significant impact on patients' lives and that AMR is a serious problem, though many did not have confidence in their own knowledge of AMR., (© 2023. The Author(s).)

Purpose: Palbociclib was the first cyclin-dependent kinase 4/6 inhibitor approved by the US Food and Drug Administration for use in combination with aromatase inhibitors (AIs) as initial endocrine-based therapy or with fulvestrant in postmenopausal women who previously received endocrine therapy based on data from randomized clinical trials. Real-world studies examining the effectiveness of palbociclib in large, diverse patient populations in routine clinical practice were needed., Patients and Methods: Ibrance Real World Insights (IRIS) was a retrospective medical record review study of women with confirmed hormone receptor-positive, HER2-negative advanced/metastatic breast cancer treated with palbociclib plus an AI or with palbociclib plus fulvestrant according to approved indications. Participating physicians reviewed medical records of up to 16 sequentially presenting patients, collecting demographic and clinical data. Outcomes included objective response rates, progression-free rates, and survival rates overall and in patients stratified according to age, race and ethnicity, Eastern Cooperative Oncology Group (ECOG) performance status (PS), disease-free interval, visceral disease, liver metastases, bone-only metastases, and previous lines of therapy., Findings: Data were abstracted by 417 physicians for 2954 patients in 13 countries; 1415 patients (47.9%) were ≥65 years of age, 369 patients (12.5%) had an ECOG PS ≥2 at initiation, and 835 patients (28.3%) were races other than White. The 12-month progression-free rate was 88% for palbociclib plus an AI and 79% for palbociclib plus fulvestrant; the 12-month survival rate was 96% in both groups. The objective response rates were 80% for palbociclib plus an AI and 75% for palbociclib plus fulvestrant. Palbociclib was similarly effective in most subgroups examined., Implications: Data from IRIS provide in-depth, real-world evidence for the use of palbociclib in a range of breast cancer populations in multiple countries. These data support the findings of the randomized PALOMA-2 and PALOMA-3 studies., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: This study examined real-world treatment and management of bacillus Calmette-Guérin (BCG)-unresponsive patients across 3 continents, including patients unable or unwilling to undergo cystectomy., Materials and Methods: Physicians actively involved in managing patients with nonmuscle invasive bladder cancer completed online case report forms for their 5 consecutive patients from the broad BCG-unresponsive population and a further 5 consecutive BCG-unresponsive patients who did not undergo cystectomy (in Japan, physicians provided a total of 5 patients across both cohorts)., Results: Most patients had received 1 (37%) or 2 (24%) maintenance courses of BCG. Five or more maintenance BCG courses were received by patients in Japan (59%) and China (31%), while in Germany 76% of patients received only 1 course. Most patients became BCG-unresponsive during their first (44%) or second (22%) treatment course; in Germany, 77% became BCG-unresponsive during their first treatment course. Most countries did not provide another course of BCG after a patient first became unresponsive, whereas unresponsive patients in Japan and China were most likely to be retreated with BCG. "Untreated - on watch and wait" was the main treatment/management approach received post-BCG treatment for 42% or more of patients in most countries except China (39%) and the United States (36%). "Following treatment guidelines" was consistently the top reason for post-BCG treatment selection across all treatment options., Conclusions: This study confirmed the global unmet need for patients with nonmuscle invasive bladder cancer, and found that many patients experienced periods of no treatment after not responding to BCG therapy., (Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc.)

Background: Malignant pleural mesothelioma (MPM) is an aggressive and rare tumour with poor prognosis. Most patients are diagnosed with advanced disease and there is a paucity of data on the humanistic burden of MPM in terms of impact on health-related quality of life (HRQoL) and activity. This study examined real-world treatment patterns and humanistic disease burden of MPM in Europe., Methods: Physicians abstracted demographic/clinical characteristics and treatment data from MPM-patient medical records; MPM patients self-completed a questionnaire including symptoms, 3-level-EQ-5D questionnaire and Visual Analogue Scale (VAS), Lung Cancer Symptom Scale for Mesothelioma (LCSS-Meso), and Work Productivity and Activity Impairment (WPAI) questionnaire., Results: Physicians (n = 171) abstracted data of 1390 patients; 767/1390 patients self-completed questionnaires. Patients were elderly with advanced, unresectable MPM. Treatment patterns followed guidelines with most (81%) patients receiving platinum+antifolate chemotherapy at first line (1 L). Maintenance treatment use was high (51.1%) despite no recommended maintenance therapies. Symptom burden was high and health states and HRQoL were poor at 1; declining further with progression. Overall mean (SD): LCSS-Average Symptom Burden Index score was 48.8 (19.3; n = 758); EQ-5D Utility Index score was 0.510 (0.349; n = 763); EQ-5D VAS score was 54.2 (20.3;n = 766); LCSS-3-Item Global Index score was 143.2 (64.5; n = 762); LCSS-normal activities score was 51.9 (24.6;n = 765); WPAI-activity impairment was 56.0% (23.2%; n = 737)., Conclusion: The humanistic burden of MPM is high, despite treatments being prescribed as per available guidance. Treatments that delay progression and provide palliation of symptoms are most likely to improve/maintain HRQoL., (© 2022. The Author(s).)

Background: Intravesical bacillus Calmette-Guérin (BCG) fails in a considerable proportion of non-muscle invasive bladder cancer (NMIBC) patients despite treatment per recommended protocol. This real-world study aimed to understand the current patterns of treatment and disease management for the broad BCG-unresponsive NMIBC patient population, alongside collecting sufficient data on patients who do not undergo cystectomy., Methods: This was a multicenter, retrospective survey of physicians treating BCG-unresponsive NMIBC patients. Data were collected in eight countries - France, Germany, Spain, Italy, United Kingdom, United States, China, and Japan - between January and May 2019. The study consisted of a short online physician survey and a retrospective chart review of eligible BCG-unresponsive NMIBC patients. Physicians abstracted chart data for the last 10 (five patients in Japan) eligible BCG-unresponsive NMIBC patients meeting the inclusion criteria, and the data were analysed for all countries combined using descriptive statistics. Country-specific analyses were also carried out, as appropriate., Results: Overall, 508 physicians participated in the study. Almost one-quarter (22.9%) of physicians' current NMIBC patient caseload was BCG-unresponsive, whereby BCG therapy was no longer considered an option. Half of physicians (49.4%) did not regularly use biomarker tests in their practice, with particularly few physicians undertaking biomarker testing in Spain and Japan. Biomarker testing varied considerably, with the proportions of physicians selecting 'none' ranging from 11.4% in China to 70.3% in Japan. Physicians reported transurethral resection of the bladder tumor (TURBT) and BCG as the most common current treatments received by their patients. Chemotherapy and anti-PD-L1 treatment options were considered impactful new therapies by 94.7% and 90.0% of physicians surveyed in this study, respectively., Conclusions: The most common treatments received by patients in this study were TURBT and BCG. Emerging new treatments are driven by exploring biomarkers, but in real-world clinical practice only half of physicians or fewer regularly tested their NMIBC patients for biomarkers; PD-1/PD-L1 was the most common biomarker test used. Most physicians reported that, in addition to chemotherapy, anti-PD-L1 was an impactful new therapy., (© 2022. The Author(s).)