Nuria Lara

Systematic Review of Tumor Necrosis Factor Antagonists in Extraintestinal Manifestations in Inflammatory Bowel Disease

BACKGROUND & AIMS: This systematic review investigated the efficacy and the effectiveness of biologic drugs in extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD). METHODS: Literature search was conducted in PubMed, Embase, and Cochrane until October 2015. Main inclusion criteria were adults with IBD, use of a biologic drug, evolution of EIMs, interventional study, or non‐interventional study. RESULTS: Nine interventional studies (2 randomized controlled trials [N = 797], 7 open label trials [N = 1143], and 13 non‐interventional studies [N = 914]) were included. Tumor necrosis factor (TNF) antagonists achieved complete response for pyoderma gangrenosum in 21%–25% of patients in interventional studies and in 92%–100% patients in non‐interventional studies, with similar results for other cutaneous manifestations such as erythema nodosum or stomatitis. Adalimumab significantly reduced the prevalence of anemia vs placebo after 56 weeks in 1 randomized controlled trial. In 2 non‐interventional studies, anti‐TNF therapy improved anemia in the short‐term (67%) and in the long‐term (34%). Complete response after anti‐TNF treatment was reported in interventional studies, including arthralgia (reduction in prevalence from 47.1% to 26.8% in the mid‐term in 1 open label trial) and arthritis (reduction in prevalence from 8.7% to 2.1% and from 58% to 12.5% in 2 open label trials). Anti‐TNFs were beneficial for a majority of patients with ocular manifestations. Infliximab was associated with improved outcomes in bone formation and bone mineral density. CONCLUSIONS: Anti‐TNFs appear to be effective alternatives for certain EIMs associated with IBD including musculoskeletal, cutaneous, and ocular manifestations, and some beneficial effect may be obtained in metabolic bone disease and on hematologic or vascular EIMs.

Combination of qualitative and quantitative methods for developing a new Health Related Quality of Life measure for patients with anogenital warts

BackgroundAnogenital warts are the most easily recognized sign of genital Human Papilloma Virus infection. The objective was to develop a short, valid and reliable questionnaire to measure Health Related Quality of Life (HRQL) in patients with anogenital warts.MethodsFirst a literature review was performed to identify relevant papers describing the impact of anogenital warts in HRQL; second the main domains were identified by some experts in a focus group, and third in-depth-semi-structured interviews were conducted in patients with anogenital warts to identify the initial set of items. A qualitative reduction of the initial set of items was performed based on the mean scoring of the experts for the three scales: clarity, frequency and importance. The initial questionnaire was pilot tested in 135 patients. Rasch analysis was performed with the results of the questionnaire in order to refine the instrument. Spearmans correlation was calculated between the initial questionnaire and the reduced version. Additionally the measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbachs Alpha and item-total correlation).Resultsthe main domains identified as affected in patients life were: sexual, colleagues and partner relationships. After a proper qualitative reduction the initial set of 134 items was reduced to 22. The questionnaire was pilot tested in 135 patients and two dimensions were identified after the multifactorial analysis: emotional dimension and sexual activity dimension. As a result of the Rasch analysis the questionnaire was reduced to 10 items. High correlation was found between the initial and the reduced version for the two dimensions. Cronbachs alpha values were acceptable (0.86).ConclusionThe initial 22 items questionnaire was reduced by Rasch analysis to a version of 10 items, with two dimensions: emotional and sexual. The results suggest the adequacy of the 10 items to evaluate HRQL of patients with anogenital warts in a valid and reliable way.

Validation of a new tool to assess health-related quality of life in psoriasis: the PSO-LIFE questionnaire

BackgroundSeveral questionnaires have been used to measure health related quality of life (HRQoL) in patients with psoriasis, few have been adapted for use in Spain; none of them was developed specifically for the Spanish population. The purpose of the study was to validate and assess the sensitivity to change of a new questionnaire to measure HRQOL in patients with psoriasis (PSO-LIFE).MethodsObservational, prospective, multicenter study performed in centers around Spain. Patients with active or inactive psoriasis completed the PSO-LIFE together with other Dermatology Quality of Life Index (DLQI) and Psoriasis Disability Index (PDI). A control group of patients with urticaria or atopic dermatitis was also included. Internal consistency and test-retest reliability of the PSO-LIFE were assessed by calculating Cronbach’s alpha and Intraclass Correlation Coefficient (ICC). Validity was assessed by examining factorial structure, the capacity to discriminate between groups, and correlations with other measures. Sensitivity to change was measured using effect sizes.ResultsThe final sample included for analysis consisted of 304 patients and 56 controls. Mean (SD) age of psoriasis patients was 45.3 (14.5) years compared to 38.8 (14) years for controls (p < 0.01). Cronbach’s alpha for the PSO-LIFE was 0.95 and test-retest reliability using the ICC was 0.98. Factor analysis showed the questionnaire to be unidimensional. Mean (SD) PSO-LIFE scores differed between patients with psoriasis and controls (64.9 [22.5] vs 69.4 [17.3]; p < 0.05), between those with active and inactive disease (57.4 [20.4] vs 76.4 [20.6]; p < 0.01), and between those with visible and non-visible lesions (63.0 [21.9] vs. 74.8 [23.9]; p < 0.01). The correlation between PSO-LIFE and PASI scores was moderate (r = −0.43) while correlations with DLQI and PDI dimensions ranged from moderate to high (between 0.4 and 0.8). Effect size on the PSO-LIFE in patients reporting ‘much improved’ health status at study completion was 1.01 (large effect size).ConclusionsThe present results provide substantial support for the reliability, validity, and responsiveness of the PSO-LIFE questionnaire in the population for which it was designed.

Implementing the Concept of Continuous Clinical Response Into Clinical Practice for Ulcerative Colitis.

Background & Aims Ulcerative colitis (UC) is a complex and progressive disease that has a significant humanistic and economic impact in patients and the wider society. Disease control is still an unmet need for a large proportion of patients. The aim of this article was to review the current evidence to assess the feasibility, value, and impact of integrating continuous clinical response (CCR) as a patient‐reported outcome into routine management of UC. Methods Literature searches in PubMed, Google Scholar, and conference proceedings were undertaken to retrieve the relevant articles regarding burden and course of disease, outcome measures in UC, tools for measuring disease activity, and models for patients self‐monitoring. Results The concept of CCR was first introduced during the PURSUIT‐M trial, where evidence was provided to support the clinical and quality of life benefits of achieving CCR. However, patient monitoring as implemented during the trial was not feasible for its use in the real world. Thus, a simple self‐reported score (eg, PRO2) to monitor CCR, with good correlation with more complex procedure‐driven indices, was identified for its use in routine patient care. Feasibility of introducing this easy‐to‐use tool over time as an integral part of patient management was also explored. Conclusions The introduction of CCR as a management goal for UC patients may pose the step change needed to improve disease course and patients life. Providing patients with simple tools to continuously monitor their disease activity is the first step for an integrated self‐monitoring model of care in UC.

Pauta de tratamiento inicial en pacientes con osteoporosis: uso de antirresortivos y suplementos farmacológicos (calcio y vitamina D) en la práctica clínica

OBJECTIVE To describe the percentage of prescription of pharmacologic supplements in patients starting antiresorptive treatment (ART) for osteoporosis by specialists. DESIGN Cross-sectional, naturalistic, multicenter study with retrospective data collection. PATIENTS AND METHODS 88 Spanish primary care (PC) physicians participated as well as those from Bone Metabolism Unit / Rheumatology and Gynecology units. Patients were females with osteoporosis who started ART in the 12 to 36 months prior to the visit. MAIN OUTCOMES General clinical variables and those related to osteoporosis treatment (both ART and pharmacologic supplements) and an opinion survey on pharmacologic supplements. RESULTS 480 patients were included. Mean age (SD) was 65.8 (9.2) years. Pharmacologic supplements were prescribed in 69.6% of patients and were more frequent in patients treated in Bone Metabolism/Rheumatology Units (89.1%) than patients treated by PC (60.3%) and Gynecology (55.6%). In the physician survey, 72% of the Bone Metabolism / Rheumatology Unit physicians responded that the Vitamin D supplements were necessary for treatment of osteoporosis vs. 38.5% of PC physicians (p=0.058). CONCLUSIONS The use of pharmacologic supplements in the onset of treatment with ART represents more than 60% of the sample, although differences were seen between specialists, with a greater percentage of patients with supplements in the Bone Metabolism/Rheumatology Units than in PC and Gynecology, despite guidelines primarily recommend the use of pharmacologic supplements in these patients.

Family impact of Rotavirus Gastroenteritis in Taiwan and Vietnam: an Ethnographic Study.

BackgroundPrior to the introduction of rotavirus vaccines, rotavirus was the leading cause of severe gastroenteritis in infants and young children, and it continues to be the leading cause in countries without vaccination programs. Rotavirus gastroenteritis results in substantial economic burden and has a pronounced effect on the family of those who are ill. Both in Taiwan and in Vietnam, rotavirus illness is viewed as a priority disease. This study assessed, in Taiwan and Vietnam, the impact of rotavirus gastroenteritis on the family among a group of parents whose children had recently been hospitalized for this illness.MethodsIn the first half of 2013, parents of children who had been hospitalized due to rotavirus infection were recruited from hospitals in Taiwan (n = 12) and Vietnam (n = 22), and participated in focus group sessions or in-depth ethnographic interviews.ResultsIn both countries, the results point to a substantial burden on the parents concerning emotions and logistics of daily tasks, and to considerable disruptions of the family routine. Taiwanese parents reported satisfaction with the health care system, a great deal of effort to suppress emotions, a fair amount of knowledge about rotavirus, and little extra costs related to the illness. On the other hand, parents in Vietnam expressed concern about the emotional well-being of and the health care treatments for their children, were less knowledgeable regarding rotavirus infection, and experienced a substantial financial burden due to indirect costs that were related to accessing treatment.ConclusionsFamilies in Taiwan and Vietnam suffer from a considerable economic and emotional burden related to rotavirus gastroenteritis. One way to substantially reduce this burden is to provide universal and affordable rotavirus vaccination to susceptible children, especially since cost-effectiveness studies have demonstrated that universal vaccination would be safe and efficacious against severe rotavirus gastroenteritis in these countries.

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

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

222 for male and US

Treatment satisfaction, preferences and perception gaps between patients and physicians in the ulcerative colitis CARES study: A real world-based study.

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.

Burden of disease and patient-reported outcomes in patients with moderate to severe ulcerative colitis in the last 12 months – Multicenter European cohort study

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