E.C.Y. Wang

Assessing quality of life in the treatment of patients with age-related macular degeneration: clinical research findings and recommendations for clinical practice.

Background The importance of incorporating quality-of-life (QoL) assessments into medical practice is growing as health care practice shifts from a “disease-based” to a “patient-centered” model. The prevalence of age-related macular degeneration (AMD) is increasing in today’s aging population. The purpose of this paper is: (1) to discuss, by reviewing the current literature, the impact of AMD on patients’ QoL and the utility of QoL assessments in evaluating the impact of AMD and its treatment; and (2) to make a recommendation for incorporating QoL into clinical practice. Methods We conducted a PubMed and an open Internet search to identify publications on the measurement of QoL in AMD, as well as the impact of AMD and the effect of treatment on QoL. A total of 28 articles were selected. Results AMD has been found to cause a severity-dependent decrement in QoL that is comparable to systemic diseases such as cancer, ischemic heart disease, and stroke. QoL impairment manifests as greater social dependence, difficulty with daily living, higher rates of clinical depression, increased risk of falls, premature admission to nursing homes, and suicide. The National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) is the most widely used eye disease-specific QoL instrument in AMD. It has been shown to correlate significantly with visual acuity (VA). QoL reflects aspects of AMD including psychological well-being, functional capacity, and the ability to perform patients’ valued activities, which are not captured by a single, numerical VA score. Conclusion The literature shows that the adverse impact of AMD on QoL is comparable to serious systemic disease. Eye disease-specific instruments for measuring QoL, such as the NEI VFQ-25, have shown a significant correlation of QoL decrement with measures of disease severity, as well as significant QoL improvement with treatment. The NEI VFQ-25 and other validated instruments provide a wide-ranging assessment of vision-related functioning that is important to patients and complementary to VA measurement. We strongly recommend the incorporation of QoL assessment into routine clinical practice.

Improvement in Vision-Related Function with Intravitreal Aflibercept: Data from Phase 3 Studies in Wet Age-Related Macular Degeneration

PURPOSE To evaluate the effect of intravitreal aflibercept injection on visual function in wet age-related macular degeneration (AMD). DESIGN Prospective, multicenter, double-masked, active-controlled, parallel-group, randomized phase 3 clinical studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW] 1 and 2 [clinicaltrials.gov identifiers, NCT00509795 and NCT00637377, respectively]). PARTICIPANTS Patients (n=2419) with active, treatment-naïve, exudative AMD. This analysis included patients who received intravitreal aflibercept 2.0 mg every 8 weeks (2q8; n=607) or ranibizumab 0.5 mg every 4 weeks (0.5q4; n=595). INTERVENTION Patients were randomized 1:1:1:1 to receive intravitreal aflibercept 2q8 (after 3 initial monthly doses), intravitreal aflibercept 2q4, intravitreal aflibercept 0.5q4, or ranibizumab 0.5q4 in the study eye. Patients in the intravitreal aflibercept 2q8 group received a sham injection alternating with active treatment. MAIN OUTCOME MEASURES The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was administered at baseline and at weeks 12, 24, 36, and 52. The NEI VFQ-25 subscale scores were compared between intravitreal aflibercept 2q8 and ranibizumab 0.5q4 treatment arms, the approved dosing for each agent worldwide. Change in composite NEI VFQ-25 score was evaluated based on categorical change in visual acuity (worsened, unchanged, improved). RESULTS Baseline NEI VFQ-25 scores were similar for both treatments in both studies. Mean change from baseline to 52 weeks was similar for ranibizumab 0.5q4 and intravitreal aflibercept 2q8 across all 12 subscales, with the greatest improvements noted for mental health and general vision (9.0-11.6 points, both treatments, both studies). Improvement of 4 points or more (both treatments, both studies) also was observed for subscales near vision, distance vision, role difficulties, and dependency. Mean change from baseline to 52 weeks in NEI VFQ-25 composite score (pooled data) stratified by clinical response showed meaningful improvement only in patients who gained 5 Early Treatment Diabetic Retinopathy letters or more (7.3 and 7.8 points for intravitreal aflibercept 2q8 and ranibizumab 0.5q4, respectively). CONCLUSIONS Visual function outcomes were similar across all NEI VFQ-25 subscales over 52 weeks for intravitreal aflibercept 2q8 and ranibizumab 0.5q4, with clinically meaningful improvement recorded in 6 of 12 subscales.

Burden of menstrual symptoms in Japanese women: results from a survey-based study

Abstract Objective: Menstrual symptoms are associated with various health problems in women and may also significantly impact their lives. This study aims to assess the current burden of menstrual symptoms in Japanese women. Methods: Two online surveys were conducted among women aged 15–49 years, where sampling was designed to approximate the age and geographic distribution in Japan. The first survey collected data on menstrual symptom severity based on a modified, 35-item, Japanese version of the Menstrual Distress Questionnaire (mMDQ), current treatments, and impact on work productivity. The second survey collected costs of outpatient treatment within the previous 3 months. Additional outcomes of the second survey will be presented in a separate paper. Results: In this study, 19,254 women had menses, with 74% suffering from menstrual symptoms. A total of 50% reported pain and 19% reported heavy bleeding. Increasing severity of menstrual symptoms and self-reported heavy bleeding were related to more outpatient visits and greater work productivity loss. Among subjects with heavy bleeding, increasing severity of symptoms was related to greater interference with daily life. The estimated annual economic burden extrapolated to the Japanese female population was 683 billion Japanese Yen (JPY) or ∼8.6 billion United States Dollars (USD). Limitations: The study population may be biased due to the online survey method. Conclusions: To the authors’ knowledge, this is the first large-scale research assessing outcomes by severity categories for all menstrual symptoms and women’s perception of bleeding. A large proportion of women suffer from menstrual symptoms, and symptom severity impacts women’s lives. Menstrual symptoms lead to significant economic burden, mainly due to work productivity loss. However, the majority of women do not visit a gynecologist, even when their menstrual symptoms are severe. Thus, increasing public awareness on the recently available medical treatments has the potential to improve the overall burden of menstrual problems.

Burden of menstrual symptoms in Japanese women - an analysis of medical care-seeking behavior from a survey-based study.

Background Menstrual symptoms are associated with various health problems in women of reproductive age, and this may impact their quality of life. Despite this, Japanese women are likely to hesitate seeking a specialist’s medical help for their menstrual symptoms. Purpose To study subject parameters including symptom severity, gynecological disorders, and treatments in medical care-seeking women (outpatient) and women opting for self-care (nonvisit), to identify reasons why Japanese women do not see a gynecologist, and to document the benefit of gynecologist visits by assessing the impact on women’s daily lives. Methods Two online surveys were conducted among women aged 15–49 years. Sampling was structured to approximate the age and geographic distribution in Japan. Results of the first survey and part of the second survey on the overall current burden of menstrual symptoms are reported in a separate publication. Further outcomes from the second survey reported in this paper included data from the outpatient (n=274) and nonvisit (n=500) groups on symptom severity, gynecological disorders, medical treatment use, reasons for not seeking medical care, and the improvement of daily life. Results The outpatient group tended to have greater symptom severity compared to the nonvisit group. Uterine fibroids, dysmenorrhea, endometriosis, and premenstrual syndrome were the most commonly self-reported diagnoses, and oral contraceptives were frequently prescribed at gynecologist visits. Nonvisit group subjects felt that gynecologist consultations were unnecessary or felt resistant to them. Daily life was significantly improved after medical treatment from a gynecologist visit with associated economic savings, whilst the nonvisit group had no change after taking over-the-counter drugs to relieve their menstrual symptoms. Conclusion The present study results indicate that Japanese women who were suffering from menstrual symptoms could benefit from visiting a gynecologist for easing their symptoms, hence improving their daily life.

The clinical and economic impact of pneumococcal conjugate vaccine associated herd immunity in Canada

Summary Since mid-2001 a heptavalent pneumococcal conjugate vaccine (PCV-7) against seven common pneumococcal serotypes has been available in Canada. The purpose of this study was to build upon existing economic evaluations and use recent herd immunity evidence to estimate the real-world clinical and economic effectiveness of PCV-7 in Canada. Effectiveness trial data evaluating the broad population level benefits of a PCV-7 programme in the United States (US) was reviewed. Estimates of the clinical and economic impacts of PCV-7 on adult pneumococcal disease were determined based on epidemiological and cost data available from the US and Canada. Using recent effectiveness data demonstrating the herd immunity effect of PCV-7, Canada ould prevent 8,531 cases of adult pneumococcal disease with an estimated reduction of 51 cases of meningitis, 785 cases of bacteraemia, and 7,695 cases of pneumonia, respectively. This reduction in adult disease not only represents a substantial clinical benefit but is also expected to save an additional Canadian

Burden of comorbidities among Japanese patients with atrial fibrillation: a case study of dyspepsia

40 million from the Canadian healthcare system perspective. Herd immunity resulting from a universal childhood PCV-7 programme will have a substantial clinical and economic impact on populations > 20 years of age, thereby making PCV-7 a clinically important and cost-saving intervention for the Canadian healthcare system.

Characteristics, treatment patterns, and unmet needs of Japanese patients with atrial fibrillation

Background The aim of this study was to investigate the link between atrial fibrillation (AF) and dyspepsia, as well as the contribution of dyspepsia to the overall burden of AF. Methods The 2008, 2009, and 2010 Japan National Health and Wellness Survey (NHWS) datasets were used in this study. The NHWS is an Internet-based survey administered to the adult population in Japan using a random stratified sampling framework to ensure demographic representativeness. The presence of dyspepsia was compared between those with and without AF. Among those with AF, the effect of dyspepsia on health status, work productivity, and activity impairment was examined, along with health care resource use using multivariable regression modeling and controlling for baseline differences. Results Among patients with AF (n = 565), the three most commonly reported comorbidities were hypertension (38.76%), dyspepsia (37.35%), and overactive bladder (28.72%). Patients with AF had 48.59% greater odds of reporting dyspepsia than those without AF (P < 0.05). Patients with dyspepsia used more AF medications (2.05 versus 1.54) and had been diagnosed more recently (9.97 versus 10.58 years). Dyspepsia was associated with significantly worse physical health status (P < 0.05) and significantly more absenteeism, overall work impairment, activity impairment, physician visits, and emergency room visits (all P < 0.05). Conclusion Patients with AF in Japan experience a number of comorbidities, with dyspepsia being the most common noncardiovascular comorbidity. Given the prevalence and additional burden of this comorbidity across both humanistic and economic outcomes, the management of dyspepsia among patients with AF should be an area of greater focus.

Burden of comorbidities among Japanese patients with atrial fibrillation: a case study of dyspepsia [Corrigendum]

Correspondence: Marco DiBonaventura Health Outcomes Practice, Kantar Health, 11 Madison Avenue, 12th Floor, New York, NY 10010 USA Tel +1 212 706 3988 Fax +1 212 647 7659 Email marco.dibonaventura@kantarhealth. com Background: Data on characteristics, comorbidities, health outcomes, and treatment patterns of patients with atrial fibrillation (AF) in Japan are scarce. The aim of this study was to address this gap in order to better understand the characteristics of Japanese AF patients. Methods and results: The 2008−2010 Japan National Health and Wellness Survey data sets were used in this study (N = 60,015). Demographics, health characteristics, stroke risk (using the CHA 2 DS 2 -VASc score), comorbidities, and health outcomes were all assessed. A total of 565 patients (0.94%) self-reported a physician diagnosis of AF. Patients with AF reported a number of comorbidities, including another cardiovascular condition (87.08%), a urological condition (67.79%), and dyspepsia (37.35%). Patients with AF also reported significantly worse health status and significantly more resource use than did controls. Based on the CHA 2 DS 2 -VASc score, most patients (88.50%) were at either moderate or high risk, yet only 64.25% of patients were currently being treated. Among those not currently treated, 42.57% had discontinued previous treatment. Among those currently treated, over a third reported nonadherent behaviors. Conclusion: Despite the disease burden and the high risk for a future stroke, not all patients are being treated according to guidelines. This treatment gap highlights the need for better therapeutic alternatives, in order to improve the management of patients with AF, in Japan.

Higher Doses of Subcutaneous IgG Reduce Resource Utilization in Patients with Primary Immunodeficiency

[This corrects the article on p. 51 in vol. 6, PMID: 23717048.].