Human papillomavirus-driven head and neck cancers in Japan during 2008-2009 and 2018-2019: The BROADEN study.

There is limited understanding of epidemiology and time trends of human papilloma virus (HPV)-driven head and neck cancers (HNC) in Japan, especially outside of the oropharynx. To assess HPV-driven HNC, a non-interventional study (BROADEN) of HNC patients diagnosed in 2008-2009 and 2018-2019 was conducted in Japan. Adult patients with oropharyngeal, nasopharyngeal, laryngeal, hypopharyngeal or oral cavity cancers were included in this study. HPV was centrally tested using p16INK4a immunohistochemistry, HPV-DNA PCR and HPV E6*I mRNA. HPV attributability required positivity in at least two tests (p16INK4a immunohistochemistry, HPV-DNA PCR, HPV E6*I mRNA) in the oropharynx, and HPV-DNA and HPV E6*I mRNA positivity for non-oropharynx sites. Nineteen hospitals included a total of 1108 patients, of whom 981 had valid samples. Men accounted for 82% of HNC diagnoses. Patients in the earlier cohort were younger and included a higher percentage of smokers. There was an increasing trend of HPV-driven oropharyngeal cancer over the last decade, from 44.2% to 51.7%. HPV attribution in nasopharyngeal cancers was 3.2% in 2008-2009 and 7.5% in 2018-2019; and 4.4% and 0% for larynx respectively. In total, 95.2% of HPV-driven HNC were attributed to HPV genotypes included in the 9-valent HPV vaccine being HPV16 the most prominent genotype. These results suggest that an epidemiologic shift is happening in Japan, with a decrease in smoking and alcohol use and an increase in HPV-driven HNC. The increasing trend of HPV-driven HNC in Japan highlights the need for preventive strategies to mitigate the rise of HPV-driven HNC.

Treatment Patterns and Clinical Outcomes of Patients with Moderate to Severe Acute Graft-Versus-Host Disease: A Multicenter Chart Review Study.

Acute graft-versus-host disease (aGVHD) remains a barrier to successful allogeneic hematopoietic stem cell transplantation (HSCT) outcomes. Contemporary comprehensive analyses of real-world clinical outcomes among patients who develop aGVHD post-HSCT are needed to better understand the unmet needs of this patient population. This multicenter, retrospective chart review describes treatment patterns and clinical outcomes among patients (≥18 years old) from Finland, Sweden, and France who developed grades II-IV aGVHD after their first HSCT (January 2016-June 2017). From 13 participating centers, 151 patients were included. The median (Q1, Q3) age at HSCT was 56 (45, 62) years old. One line of aGVHD treatment was received by 47.7%, and the most common first-line treatment was methylprednisolone (alone or in a combination regimen, 74.2%; monotherapy, 25.8%). Among patients treated with methylprednisolone, 79.5% achieved a complete or partial response. The median (Q1, Q3) number of treatment lines was 2.0 (1.0, 3.0). The median (Q1, Q3) time to obtain an aGVHD diagnosis from transplant was 29.5 (21.0, 44.0) days, and 14.5 (7.0, 34.0) days to achieve the best response for 110 evaluable patients. At 6 and 12 months, 53.6% and 49.0%, respectively, achieved a complete response. Chronic GVHD occurred in 37.7% of patients, and aGVHD reoccurred in 26.5%. Following aGVHD diagnosis, mortality rates were 30.0% at 6 months and 37.3% at 12 months. Findings from this study demonstrate a continuing unmet need for new therapies that control aGVHD and improve mortality.

The EASEMENT study: A multicentre, observational, cross-sectional study to evaluate patient preferences, treatment satisfaction, quality of life, and healthcare resource use in patients with multiple myeloma receiving injectable-containing or fully oral therapies.

OBJECTIVE: As multiple myeloma (MM) therapies advance, understanding patients', caregivers', and physicians' perspectives on, and satisfaction with, available treatment options and their impact on quality of life (QoL), is important. METHODS: EASEMENT is a real-world, observational, cross-sectional study conducted in 19 sites within the UK, Canada, and Italy using retrospective chart reviews and surveys. Enrolled patients had clinical history available since diagnosis and had received ≥1 cycle of their current line of therapy. Primary objectives were to describe patient/caregiver QoL (EQ-5D-5L questionnaire), patient preference for oral/injectable therapies (single discrete-choice question), and patient satisfaction (TSQM-9 questionnaire). RESULTS: Between October 2018 and March 2020, 399 patients were enrolled (n = 192 newly diagnosed multiple myeloma [NDMM], n = 206 relapsed/refractory multiple myeloma [RRMM], n = 1 missing). Among NDMM and RRMM patients, 78%/22% and 42%/58% were receiving injectables/orals, respectively. Both NDMM and RRMM patients significantly preferred orals versus injectables (p < .0001). No significant differences were reported in treatment satisfaction or QoL, but treatment convenience favoured orals over injectables with near significance (p = .053). CONCLUSION: MM patients perceived greater convenience and preference for orals versus injectables. Oral treatments are useful for patients who cannot or prefer not to travel to clinics, or cannot perform self-injection within the community.

Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn's disease in Europe: a retrospective observational study.

BACKGROUND: Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn's disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland. METHODS: This retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups. RESULTS: Overall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0-98.0] and 95 [70.0-98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%). CONCLUSIONS: In this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD. TRIAL REGISTRATION: Not applicable.

Treatment patterns and outcomes among patients with small-cell lung cancer (SCLC) in Europe: a retrospective cohort study.

OBJECTIVE: Describe characteristics, treatment patterns and clinical outcomes of patients with small-cell lung cancer (SCLC). DESIGN: Retrospective chart review study defining several cohorts: (1) limited-stage disease (LD) SCLC initiating 1L therapy (1 L LD-SCLC), (2) extensive-stage disease (ED) SCLC initiating 1L therapy (1L ED-SCLC) and (3) patients initiating 2L therapy. SETTING: 39 physicians (medical oncologists, thoracic oncologists and/or pulmonologists) from France, Italy and the UK. PARTICIPANTS: Patients >18 years of age with a confirmed diagnosis of LD-SCLC or ED-SCLC and a full oncology medical history. Patients included initiated a 1L (2013-2015) or 2L (2013-2016) treatment (chemotherapy and/or radiotherapy-RT). PRIMARY AND SECONDARY OUTCOME MEASURES: Overall survival (OS) and progression-free survival (PFS). RESULTS: 231 patients in 1L LD-SCLC, 308 in 1L ED-SCLC and 225 with relapse/refractory SCLC initiating 2L treatment were included. The proportion of men was higher across all groups (56.8% to 68.5%) and mean age at time of diagnosis was 66.0 and 65.4 years in 1L LD-SCLC and 2L ED-SCLC cohorts. The majority of patients in LD-SCLC 1L group received chemotherapy with RT (76.2%). Patients initiating 2L therapy predominantly received chemotherapy alone (79.6%).Median OS in 1 L patients was 17.3 months in LD-SCLC and 8.8 months in ED-SCLC. Median PFS was 11.6 months in LD-SCLC and 6.1 months in ED-SCLC patients. Median OS in patients initiating 2L treatment was 6.6 months. OS from start of 2L treatment was lower in patients initially diagnosed with ED (5.1 months) than in patients initially diagnosed with LD (9.3 months) (p<0.0001). OS and PFS were assessed from the start of 1L or 2L therapy, depending on the cohort. CONCLUSIONS: Despite the availability of a high number of treatments and combinations, the prognosis of SCLC is still unsatisfactory, especially for those patients diagnosed with ED-SCLC, indicating high unmet need in this patient population.

Burden of hospitalizations and outpatient visits associated with moderate and severe acute graft-versus-host disease in Finland and Sweden: a real-world data study.

PURPOSE: The aim of this study was to describe patient characteristics and quantify hospital stays and outpatient visits (H&OV) following diagnosis with moderate-to-severe acute graft-versus-host disease (aGVHD) in Finland and Sweden. METHODS: A retrospective chart audit collected data from patient medical records of 3 specialized centers performing allogeneic hematopoietic stem cell transplantation (HSCT; Finland, n = 2; Sweden, n = 1). Eligible patients received allogeneic HSCT (January 1, 2016-June 30, 2017) from any donor source, were diagnosed with grade II-IV aGVHD (MAGIC or modified Glucksberg criteria) at any time from transplantation to 12 months before data collection, and were ≥ 18 years old at diagnosis. Criteria for comparing patients graded with modified Glucksberg and MAGIC severity scales were defined. RESULTS: Fifty-five patients (Finland, n = 45; Sweden, n = 10) were included. Myeloablative conditioning was the most common conditioning regimen (81.8%); immunosuppression regimens were based on combinations of methotrexate (96.4%), in vivo T-cell depletion (80.0%), cyclosporine (63.6%), mycophenolate (40.0%), and tacrolimus (34.5%). Sixteen patients (29.1%) developed grade III/IV aGVHD; skin was the most common organ involved (80.0%). Most patients required ≥ 1 hospital stay (89.1%; median of 2 hospitalizations per patient); 7 patients (14.3%) required admission to an intensive care unit. Median hospitalization duration from HSCT to discharge was 26 days. Most patients also required outpatient or emergency department visits (90.9%). Subgroup analyses showed longer hospital stays for patients receiving multiple treatment lines; no clear differences in H&OV were observed between prophylactic regimens. CONCLUSION: Based on this retrospective study, moderate-to-severe aGVHD is associated with considerable healthcare resource utilization in Finland and Sweden, particularly in patients who received multiple lines of therapy.

Real-World Treatment Patterns and Clinical Outcomes for Standard of Care Regimens in Patients with Deficient MMR or MSI-High Metastatic Colorectal and Non-Colorectal Cancer: A Retrospective Chart Review Study in France.

INTRODUCTION: There is limited evidence on the effectiveness of standard of care (SOC) treatments in previously treated patients with deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) metastatic cancer. Immune checkpoints inhibitors (ICIs) have emerged as key treatments for dMMR/MSI-H tumors. However, clinical outcomes data with SOC regimens are still limited. Study objectives were to evaluate real-world treatment patterns and clinical outcomes in patients with dMMR/MSI-H metastatic colorectal cancer (mCRC) and non-CRC receiving SOC regimens. Given the resulting small cohort of patients with metastatic non-CRC, only summary results are provided. METHODS: Two French university hospitals participated in a retrospective chart review study in which adult patients with dMMR/MSI-H mCRC and non-CRC were enrolled. Treatment patterns, overall survival (OS) from the start of third-line (3L, for mCRC) or second-line (2L, for non-CRC) treatment, and the best overall response rate (BORR) were reported. RESULTS: Thirty-six patients with dMMR/MSI-H mCRC were included. Almost all patients received combination treatments both in first-line (1L, 100%) and 2L (97%). For 3L and later, combination treatment was preferred over monotherapy but decreased in usage (75% at 3L and 57% at fourth-line, 4L). The BORR was 5.7% and median OS for patients with dMMR/MSI-H mCRC receiving 3L therapy was 9.0 months (95% confidence interval, CI 4.0-14.1); it decreased to 4.1 months (95% CI 4.0-9.0) when survival data of patients receiving ICIs at fourth or later lines were censored at progression date of prior treatment line. CONCLUSION: Real-world clinical outcomes observed for patients with dMMR/MSI-H mCRC receiving 3L treatment(s) are suboptimal, suggesting a high unmet need that could be addressed with ICIs.

Assessing the Progression of Alzheimer's Disease in Real-World Settings in Three European Countries.

BACKGROUND: There exists considerable variation in disease progression rates among patients with Alzheimer's disease (AD). OBJECTIVE: The primary objective of this observational study is to assess the progression of AD by characterizing cognitive, functional, and behavioral changes during the follow-up period between 6 and 24 months. METHODS: A longitudinal prospective study with community-dwelling patients with an established clinical diagnosis of AD of mild to moderate severity was conducted in Germany, Spain and the UK. A sample of 616 patients from 69 sites was included. RESULTS: Patients had a mean of 1.9 years (SD = 1.9) since AD diagnosis at study inclusion. Cognitive symptoms were reported to have first occurred a mean of 1.1 years (SD = 1.7) prior to AD diagnosis and 1.4 (SD = 1.8) years prior to AD treatment. Patients initially diagnosed with mild and moderate AD spent a median (95%CI) of 3.7 (2.8; 4.4) and 11.1 (6.1, 'not reached') years until progression to moderate and severe AD, respectively, according to the Mini-Mental State Examination (MMSE) scores. A mixed model developed for cognitive, functional, and neuropsychiatric scores, obtained from study patients at baseline and during follow-up period, showed progressive deterioration of AD patients over time. CONCLUSION: The study showed a deterioration of cognitive, functional, and neuropsychiatric functions during the follow-up period. Cognitive deterioration was slightly faster in patients with moderate AD compared to mild AD. The duration of moderate AD can be overestimated due to the use of retrospective data, lack of availability of MMSE scores in clinical charts and exclusion of patients at time of institutionalization.

An assessment of physician reasons for prescribing Insulin Lispro 200 units/ml in Germany.

OBJECTIVE: To understand physicians' reasons for prescribing Insulin Lispro 200 units/ml (IL200) and their experience with IL200 treatment in Germany. METHODS: The survey consisted of 28 questions on physician's profile, average IL200 patients' characteristics and rationales for prescribing IL200. Questions were rated on a scale of 0 ('not at all important'/'strongly disagree') to 4 ('absolutely important'/'strongly agree'). RESULTS: The surveyed physicians had a mean (SD) experience of 18.1 (7.0) years managing diabetes, consulted an average of 226.8 patients with diabetes/month and prescribed IL200 to 56.1% of their patients on mealtime insulin (MTI). About 80.0% of IL200 patients had type 2 diabetes mellitus, were overweight/obese, and received >20 units/day of MTI. More than 70.0% of physicians rated patient's insulin dose, pattern of self-measured glucose levels, hemoglobin A1c (HbA1c) (clinical); adherence, hypoglycemia knowledge, motivation to improve lifestyle, desire to reduce injection volume and emotional struggle with controlling HbA1c (behavioral) as 'very important'/'absolutely important' factors when prescribing IL200. CONCLUSION: Physicians considered IL200 a promising treatment option that reduces the injection burden for patients on MTI. Physicians adopted a patient-centered perspective by aligning IL200 prescribing decisions with each patient's medical needs and non-clinical preferences, with an aim to encourage treatment adherence through resorting to IL200's advantageous attributes.

Estimating the burden of illness related to genital warts in the Philippines: a nationally representative cross-sectional study.

BACKGROUND: This study estimated genital warts prevalence, genital-warts-related healthcare resource use and costs, and self-reported human-papillomavirus-related psychosocial impact among male and female patients aged 18-60 years in the Philippines. METHODS: Prevalence was estimated using daily logs numbering genital warts patients treated by participating physicians in 4 Philippine regions over a 5-week period (09JUL2011-24SEP2012). Physicians also completed a survey assessing patient referral patterns, healthcare resource use, treatment, and follow-up care. Psychosocial impact was estimated using the human papillomavirus impact profile and the EQ-5D questionnaires. HIP and EQ-5D scores were compared according to the presence of GW (males) and HPV disease (females). CECA scores were also compared by gender and age groups. RESULTS: Overall genital warts prevalence was estimated at 4.78% (95% confidence interval [CI]: 4.58-4.98%) for men and women aged 18-60 years. Genital warts prevalence was 3.39% (95% CI: 3.13-3.65%) and 8.0% (95% CI: 7.69-8.31%) among women and men, respectively. Prevalence estimates were highest in infectious disease specialist practices 18.67% (95% CI: 18.66-18.69%). Two thirds of the 233 (69.14%) male and 166 (67.20%) female patients were newly-diagnosed genital warts cases. Median costs for genital warts diagnosis and treatment reached 7121 and 7000 Philippine pesos among men and women, respectively. In the Cuestionario Específico para Condiloma Acuminado questionnaire, no statistically significant differences between patients were observed. In the EQ-5D questionnaire, male genital warts patients reported lower mean visual analogue scale scores than those without genital warts (78.20 vs 86.34, p < 0.0001). Mean visual analogue scale score values and utility values were lower for women with human-papillomavirus-related diseases than those without (77.98 vs 78.93, and 0.84 vs 0.88, respectively). CONCLUSIONS: Genital warts is prevalent in the Philippines; more than 60% of cases were newly diagnosed, contributing to high genital-warts-related healthcare resource costs. Diagnosis of genital warts and human papillomavirus negatively impacted psychosocial indices such as patient well-being and health-related quality of life.

Cross-sectional study estimating the psychosocial impact of genital warts and other anogenital diseases in South Korea.

OBJECTIVES: To estimate self-reported human papillomavirus (HPV) disease-related psychosocial impact among male and female patients in South Korea. DESIGN: In this multicentre cross-sectional study, psychosocial impacts were estimated using a one-time survey capturing HPV Impact Profile (HIP) results, CuestionarioEspecifico en Condilomas Acuminados (CECA; in Spanish)-'Specific questionnaire for Condylomata Acuminata' and the EuroQol-5 Dimension (EQ-5D) surveys. Student's t-tests or Mann-Whitney U tests were used for continuous comparisons; χ2 or Fisher's exact tests were applied for categorical comparisons. SETTING: 5098 clinics throughout Seoul, Busan, Daegu, Kwangju and Daejeon (South Korea). PARTICIPANTS: Patients with and without genital warts (GW) (males) and selected HPV diseases (females) visiting primary care physicians, obstetricians/gynaecologists, urologists and dermatologists with 2-30 years experience. RESULTS: Of 150 male and 250 female patients, HIP scores showed 85.3% of male patients with GW and 32.0% without reported moderate psychological impact (p<0.0001). In categorised total scores, 88.5% of female patients with and 66.0% without selected HPV-related diseases reported moderate or high psychological impacts (p=0.0004). In the CECA questionnaire, male patients had mean (SD) scores of 10.51 (3.79) in 'emotional health' and 15.90 (6.13) in 'sexual activity'. Female patients with GW reported lower scores in both dimensions with mean scores of 7.18 (4.17) in 'emotional health' and 10.97 (5.80) in 'sexual activity' (p<0.0001), indicating worse health-related quality of life (HRQoL). For the EQ-5D, male patients with GW reported lower mean Visual Analogue Scale (VAS) scores than those without (75.1 vs 81.13, p<0.0135). Mean VAS score and utility values were lower for females with HPV-related diseases than those without (72.18 vs 76.86 and 0.90 vs 0.94, respectively). CONCLUSION: In South Korea, GW in men and HPV-related diseases in women negatively impact patient well-being and HRQoL scores. Among women, those with GW suffered a greater psychosocial impact than those with other selected HPV-related diseases.

Prevalence and Burden Related to Genital Warts in India.

The prevalence of genital warts (GW) and self-reported human papillomavirus (HPV) as well as disease-related psychosocial impact among male and female patients aged 18-60 years in India were assessed. GW prevalence was estimated using a 2-week daily log of patients examined from June 7-September 22, 2011 by 200 participating physicians in 6 regions of India. Psychosocial impact was estimated using one-time, self-administered surveys, including HPV Impact Profile (HIP), Cuestionario Específico para Condiloma Acuminado ([Spanish] CECA; "Specific questionnaire for Condylomata Acuminata") and EuroQol-5 Dimension survey. T-tests or Mann-Whitney U-tests were used for continuous comparisons and Chi-square or Fisher exact tests were applied for categorical comparisons. Overall GW prevalence in India was estimated at 1.07% (95% confidence interval = 0.97-1.17) and was higher among men than women. Regional prevalence ranged from high in Delhi (2.17%) to low in Bangalore (0.40%). Patients aged 25-29 years had the highest GW prevalence (1.42%). GW patients were most often newly diagnosed (74.07%). Among those with existing GW, 56.24% were recurrent, and 43.76% were resistant. According to total HIP scores, 55.4% of male GW patients and 20.0% of those without GW reported moderate psychological impact (p < 0.0001). HIP scores among women revealed that patients with abnormal Papanicolaou (Pap) test results (34.3%), precancerous lesions (46.2%), external GW (48.0%), and those without HPV-related disease (18.5%) reported moderate psychological impact (p = 0.0089) (Psychosocial impact results are reported in the Supplementary Data ). Estimated national GW prevalence, diagnosis, and treatment costs in India were higher for men than for women. GW in men and HPV infection in women had a negative psychosocial impact on well-being and health-related quality of life (HRQoL) scores, especially among women diagnosed with GW and precancerous lesions compared to those with other selected HPV-related diseases. Despite its limitations, this study provides an estimation of GW data in India not previously available.

Estimating the burden of genital warts in Taiwan.

Background This study aimed to estimate the prevalence of genital warts in Taiwan among those seeking healthcare, as well as genital-warts-related healthcare resource use and costs, and self-reported genital-warts-related psychosocial impact. METHODS: Genital warts prevalence estimates were extracted from a daily record of patients examined from 31 October 2011 to 4 May 2012 by 67 physicians in Taiwan. Physicians recorded the total number of patients and genital warts patients seen daily for 2 weeks. These physicians also completed a survey regarding healthcare resource use, treatment, follow-up care, and referral patterns. Patient psychosocial impact was estimated using a self-administered survey. RESULTS: The overall prevalence of genital warts in Taiwan was estimated at 1.1%, with a higher prevalence among men. A total of 146 genital warts case patients were included in the study (76 men, 70 women). Median costs for diagnosis and treatment were US$222 for male and US$351.8 for female patients. Male genital warts subjects reported a negative psychosocial impact on their well-being and health-related quality of life - psychosocial impact results are reported in the Supplementary Material file. CONCLUSIONS: Genital warts prevalence was higher among male patients; female patients incurred higher costs. Among men, genital warts had a negative psychosocial impact on well-being and health-related quality of life.

A cross-sectional study estimating the burden of illness related to genital warts in South Korea.

OBJECTIVES: Estimate the prevalence of genital warts (GW) and GW-related healthcare resource use and costs among male and female patients seeking treatment in South Korea. DESIGN: To estimate GW prevalence, physicians in five major South Korean regions recorded daily logs of patients (n=71 655) seeking care between July 26 and September 27, 2011. Overall prevalence estimates (and 95% CIs) were weighted by the estimated number of physicians in each specialty and the estimated proportion of total patients visiting each specialist type. Healthcare resource use was compared among different specialties. Corresponding p values were calculated using Mann-Whitney U tests. SETTING: The database covers 5098 clinics and hospitals for five major regions in South Korea: Seoul, Busan, Daegu, Gwangju and Daejeon. PARTICIPANTS: Primary care physicians (general practice/family medicine), obstetricians/gynaecologists, urologists and dermatologists with 2-30 years' experience. RESULTS: The estimated overall GW prevalence was 0.7% (95% CI 0.7% to 0.8%). Among women, GW prevalence was 0.6% (95% CI 0.6% to 0.7%); among men prevalence was 1.0% (95% CI 0.9% to 1.0%), peaking among patients aged 18-24 years. Median costs for GW diagnosis and treatment for male patients were US$58.2 (South Korean Won (KRW) ₩66 857) and US$66.3 (KRW₩76 113) for female patients. CONCLUSIONS: The estimated overall GW prevalence in South Korea was 0.7% and was higher for male patients. The overall median costs associated with a GW episode were higher for female patients than for male patients.

Clinical characteristics, beliefs, and coping strategies among older patients with overactive bladder.

AIMS: To describe clinical characteristics and assess beliefs and coping strategies in older patients with overactive bladder (OAB) attending urology and gynecology clinics in Spain. METHODS: This non-interventional, multicenter, cross-sectional study collected demographic and clinical details from individuals aged ≥60 years with a diagnosis of OAB and score ≥3 on the Patient Perception of Intensity of Urgency Scale. Symptoms were assessed using the Bladder Control Self-Assessment Questionnaire (B-SAQ) and Health-Related Quality of Life (HRQoL) rated using a simple visual analogue scale. Coping strategies and OAB beliefs were assessed using two specially designed questionnaires. RESULTS: Patients (n = 786) reported a mean (±SD) of 4.9 ± 2.9 urinary urgency episodes and 2.9 ± 2.3 urgency urinary incontinence (UUI) episodes per 24 hr. Mean times since diagnosis and symptom onset were 18 ± 34 and 38 ± 46 months, respectively. B-SAQ symptom and bother scores were 7.5 ± 2.3 and 8.3 ± 2.5, respectively. Most patients (92%) reported worse HRQoL after symptom onset. Approximately, 50% of patients considered their symptoms normal for their age/gender and most (71.5%) expected symptoms to worsen with age/time. However, 80% believed that symptoms would improve with treatment. For coping strategies, 81% of patients changed their urinary frequency, 71% controlled fluid intake, and 64% used pads. Use of coping strategies was associated with UI severity. CONCLUSIONS: Many older individuals view their OAB symptoms as a normal feature of age, which may delay diagnosis. Reduced HRQoL and adoption of coping strategies are also common. The results support the need for improved patient education, earlier recognition, and effective intervention in the older OAB population. Neurourol. Urodynam. 36:774-779, 2017. © 2016 Wiley Periodicals, Inc.

Is the CAT questionnaire sensitive to changes in health status in patients with severe COPD exacerbations?

The COPD Assessment Test (CAT) was validated in English showing good psychometric properties. The objective of this study is to assess the capacity of the CAT to detect changes in health status in patients experiencing COPD exacerbations (ECOPD) and to further explore the validity of the Spanish version. An observational study was conducted in 49 Spanish centres. Patients hospitalised because of ECOPD (n = 224) completed the CAT, the St. George's Respiratory Questionnaire-adapted for COPD (SGRQ-C) and the London Chest Activities of Daily Living (LCADL) questionnaire during the first 48 hours of admission and 4 ± 1 weeks after discharge. Stable patients (n = 153) also completed these at recruitment and 4 ± 1 weeks later. Over 90% of patients were male. The CAT discriminated between stable and ECOPD patients (15.8 vs 22.4, p < 0.01), as well as between patients with different levels of airflow limitation and dyspnea (MRC scale). The CAT proved sensitive to change; change in mean score was 8.9 points (effect size (ES), 0.90) in ECOPD patients reporting their health state as "much better" after discharge, 4.8 points in those reporting "quite a lot better" (ES = 0.63), and 4.6 points in those reporting "slightly better" (ES = 0.59). Cronbach's alpha and Intraclass Correlation Coefficient were 0.86 and 0.83, respectively. It correlated with both the SGRQ (r = 0.82; p < 0.01) and the LCADL (r = 0.63; p < 0.01). Change in CAT correlated well with Δ SGRQ (r = 0.63; p < 0.01). The CAT showed to be sensitive to the change in health status associated with ECOPD. We also provide evidence of the validity of the Spanish version.

Psychometric performance of the CushingQoL questionnaire in conditions of real clinical practice.

OBJECTIVE: To evaluate health-related quality of life (HRQoL) in Cushing's syndrome (CS) with the disease-generated CushingQoL questionnaire and to confirm its psychometric properties of test-retest reliability and sensitivity to change. DESIGN: Clinical practice conditions in a tertiary referral center. METHODS: The CushingQoL and EuroQoL questionnaires were administered at baseline and during follow-up and correlated with clinical parameters in 59 patients with CS. To check test-retest reliability, stable patients (either biochemically cured or with active hypercortisolism) were evaluated twice. To investigate sensitivity to change, new patients were evaluated at diagnosis and twice more following improvement after successful surgery. RESULTS: At baseline, patients with active disease scored lower (indicating worse HRQoL) than those cured on the CushingQoL (46 ± 14 vs 58 ± 20, P<0.05) but not on the EuroQoL-visual analog scale (VAS; 64 ± 20 vs 70 ± 16, P NS). Test-retest reliability of CushingQoL was confirmed in stable patients, both in the 'cured group' (intraclass correlation coefficient (ICC)=0.78, n=34) and in the 'active group' (ICC=0.66, n=14). Sensitivity to change was confirmed in the 'improvement group' (n=11), as the CushingQoL score increased 4 ± 1.5 and 9 ± 3 months after surgery (P<0.01 and <0.001 respectively); the EuroQoL-VAS only improved after 9 ± 3 months (P<0.01). Effect sizes were 1.02 and 1.86 for CushingQoL at 4 ± 1.5 and 9 ± 3 months respectively. Finally, scores of both questionnaires were correlated (r=0.504; P<0.001). CONCLUSIONS: The CushingQoL questionnaire shows good test-retest reliability and sensitivity to change in clinical practice conditions.

Using HAQ-DI to estimate HUI-3 and EQ-5D utility values for patients with rheumatoid arthritis in Spain.

BACKGROUND/OBJECTIVE: Utility values are not usually assessed in clinical trials and do not allow cost-utility analysis to be performed with the data collected. The aim of this study was to derive relation functions so that Health Assessment Questionnaire - Disability Index (HAQ-DI) scores could be used to estimate Health Utilities Index - 3 (HUI-3) and EQ-5D utility values for patients with rheumatoid arthritis (RA). METHODS: An observational, cross-sectional, naturalistic, multicentre study was conducted. A total of 244 patients aged 18 years or older, with RA according to American College of Rheumatology diagnostic criteria, were recruited. Sociodemographic and clinical variables were recorded and patients completed three generic HRQoL questionnaires: the HAQ-DI, the HUI-3, and the EQ-5D. Two linear regression models were used to predict HUI-3 and EQ-5D utility values as functions of HAQ-DI scores, age, and gender. RESULTS: Patient mean age was 57.8 years old (standard deviation [SD], 13.3 years); 75.8% of the patients were women and 95.9% were white. Mean disease duration was 10.8 years (SD, 9 years). Patient distribution according to HAQ-DI severity was as follows: HAQ-DI < 0.5, 29%; 0.5 ≤ HAQ-DI < 1.1, 28%; 1.1 ≤ HAQ-DI < 1.6, 16%,1.6 ≤ HAQ-DI < 2.1, 15%; and HAQ-DI ≥ 2.1, 12%. HAQ-DI and EQ-5D mean scores were 1.02 (SD, 0.78) and 63.1 (SD, 20.3), respectively. Mean utility values for HUI-3 and time trade-off (TTO) were 0.75 (SD, 0.21) and 0.65 (SD, 0.3), respectively. The equations converting HAQ-DI scores to utilities were HUI-3 = 0.9527 - (0.2018 × HAQ-DI) +ε (R(2)=0.56), and TTO = 0.9567 - (0.309 × HAQ-DI) + ε (R(2)=0.54). Error distribution was non-normal. Age and gender were found to have no bearing on the utility functions. CONCLUSIONS: HAQ-DI scores can be used to estimate HUI-3 and EQ-5D utility values for patients with RA in data obtained from studies where utility values have not been collected.

Diagnóstico de asma alérgica en consultas de alergología y neumología / Diagnosis of allergic asthma in allergy and pneumology outpatient clinics

Objetivo: Estimar la prevalencia del diagnóstico de asma alérgica en pacientes con asma persistente que acuden a consultas de alergología y neumología y describir el tratamiento clínico de estos pacientes. Métodos: Se incluyó aleatoria y retrospectivamente a 382 pacientes (12-65 años de edad) con diagnóstico de asma persistente (criterios GINA) que acudieron a las consultas de neumología y alergología. Se definió asma alérgica como la presencia de sensibilización a alérgenos comunes en pruebas cutáneas y/o determinaciones de inmunoglobulina (Ig) E específica. Se recogió también información sobre el tratamiento recibido para el asma. Resultados: Se realizaron estudios alergológicos en el 99,5 y el 76,5% de los pacientes que acudieron a las consultas de alergología y neumología, respectivamente. Se estableció el diagnóstico de asma alérgica en el 90,6 (intervalo de confianza [IC] del 95%, 86,5-94,7) y el 46,1% (IC del 95%, 39,0-53,2) de los éstos, respectivamente. La prevalencia de diagnóstico de asma alérgica fue mayor entre los pacientes más jóvenes, los varones y los menos graves. El 14,1% de los pacientes de alergología y el 23,0% de neumología presentaban asma persistente grave. Un 24,0% de los pacientes de alergología y un 5,7% de los de neumología se trataban exclusivamente con broncodilatadores. Conclusiones: El diagnóstico de asma alérgica fue muy superior en las consultas de alergología que en las consultas de neumología. Parte de las diferencias pueden ser debidas a una mayor realización de estudios alérgicos en las consultas de alergología, aunque la mayor diferencia probablemente sea debida a los diferentes perfiles de los pacientes que llegan a cada una de estas consultas especializadas

Objectives: To estimate the prevalence of diagnosis of allergic asthma in patients with persistent asthma attending allergy or pneumology outpatient clinics and to describe the clinical management of asthma in these patients. Methods: Systematic random sampling was used to retrospectively include 382 patients aged between 12 and 65 years old with a diagnosis of persistent asthma (according to GINA criteria) who had attended allergy or pneumology outpatient clinics during the previous year. Allergic asthma was defined as the presence of sensitization to any common allergen according to the results of specific IgE determinations and/or skin tests. Data on the treatment of asthma were gathered. Results: Allergy studies were performed in 99.5% of the patients attending allergy centers and in 76.5% of those attending pneumology centers. A diagnosis of allergic asthma was made in 90.6% (95% CI: 86.5-94.7) and 46.1% (95% CI: 39.0-53.2), respectively. The prevalence of allergic asthma was highest in young male patients with less severe asthma. According to the GINA criteria, 14.1% of patients from allergy centres and 23.0% of those from pneumology centers were classified as having severe persistent asthma. Twenty-four percent of patients attending allergy clinics and 5.7% of those attending pneumology centers received bronchodilator treatment exclusively. Conclusions: Diagnosis of allergic asthma was much higher in allergy clinics than in pneumology centres. Although some of this difference may be due to more frequent performance of allergy studies in allergy clinics, the most probable explanation lies in the differences observed in the profiles of patients attending the two types of center