Assessing clinical benefit response in the treatment of gastric malignant ascites with non-measurable lesions: a multicenter phase II trial of paclitaxel for malignant ascites secondary to advanced/recurrent gastric cancer.

BACKGROUND: Paclitaxel has shown promise against advanced gastric cancer and associated malignant ascites with non-measurable lesions. In order to evaluate the therapeutic effect of paclitaxel against malignant gastric ascites, a prospective phase II clinical trial was designed according to our previously proposed criteria represented by the clinical benefit response in gastric cancer (CBR-GC) criteria and the five-point method (5PM). METHODS: Patients with advanced gastric cancer with malignant ascites were treated with 1-h intravenous (i.v.) infusions of 80 mg/m² of paclitaxel weekly over a 3-week cycle on days 1, 8, and 15, followed by 1 week of rest. Therapeutic responses were measured according to the CBR-GC criteria and the 5PM. RESULTS: The CBR-GC criteria showed improved ascites volume and functional status in 39.1% of patients. A positive CBR-GC response in abdominal girth was seen in 31.3% of patients, and this was significantly correlated with the 5PM-estimated change in ascites volume (p < 0.001). The median number of treatment cycles was 3 (range 1-12). The most common non-hematological toxicity was anorexia, in 22.2% of patients. CONCLUSION: Weekly i.v. paclitaxel is a safe and effective chemotherapeutic regimen based on validated CBR-CG criteria.

Prognostic factors of long-term outcomes after ossiculoplasty using multivariate analysis.

The objective of the retrospective study is to investigate the prognostic factors of long-term outcomes following ossiculoplasty. The setting was a tertiary referral and academic center. The series consisted of 269 patients, who underwent ossiculoplasty by the same surgeon between 1989 and 2003 and were followed for more than 5 years. Postoperative hearing outcomes were considered successful, if the postoperative air-bone gap was <20 dB. Prognostic factors were analyzed using multivariate analysis with logistic regression. Successful hearing was achieved in 143 patients (53.2%). The presence of the stapes and primary surgery was significantly favorable predictive factors. Better knowledge of these predictive factors may contribute to improve the surgeon's judgement and the information given to the patients preoperatively.

Prognostic factors for short-term outcomes after ossiculoplasty using multivariate analysis with logistic regression.

OBJECTIVE: To investigate prognostic factors for short-term hearing outcomes after ossiculoplasty. DESIGN: Retrospective study. SETTING: Tertiary referral and academic center. PATIENTS: Seven hundred twenty patients who underwent ossiculoplasty performed by a single surgeon from January 1, 1989, through December 31, 2006, and who were followed up for longer than 1 year. MAIN OUTCOME MEASURES: Hearing outcomes were considered successful if the postoperative air-bone gap was 20 dB or less. The prognostic factors were analyzed using multivariate analysis with logistic regression. RESULTS: Hearing outcomes were successful in 505 patients (70.1%). Presence of the stapes superstructure, presence of the malleus handle, normal mucosa, normal stapes mobility, and use of local anesthesia were significantly favorable predictive factors. CONCLUSIONS: Multivariate analysis should be performed to investigate prognostic factors of favorable short-term hearing outcomes after ossiculoplasty. Better knowledge of these predictive factors may contribute to the surgeon's judgment and the information given to patients.

Long-term outcomes after tympanoplasty with and without mastoidectomy for perforated chronic otitis media.

The objectives of the retrospective study, performed at a tertiary referral center, were to examine the prognostic factors predicting long-term outcomes of tympanoplasty for perforated chronic otitis media (COM) and to determine whether mastoidectomy can be avoided during tympanoplasty for perforated COM. Between 1987 and 2002, 213 patients with perforated COM underwent tympanoplasty by the same surgeon and were followed for more than 5 years. Postoperative hearing outcomes were considered successful, if the postoperative air-bone gap was within 20 dB. Closure of perforation by a single surgery was considered a successful graft. Long-term outcomes were analyzed using logistic regression analysis. Normal ossicular chain was the only factor that showed a significantly favorable relation to long-term hearing outcomes. There were no significant predictors of long-term successful graft outcomes. Mastoidectomy was not a significant factor predicting long-term outcomes. Our long-term outcomes showed that mastoidectomy can be an avoidable surgical procedure in tympanoplasty for perforated COM, even if the ear is infected.

Management patterns and healthcare costs for hospitalized patients with cerebral infarction.

OBJECTIVES: Although evidence shows the importance of specialized intensive care of patients with cerebral infarction, it is not well known whether resources are generously applied in the initial period and how patterns of medical resource utilization are associated with characteristics of providers and patient outcomes. In this study, we analyzed changing patterns of daily medical cost using administrative healthcare claim data and identified a management pattern in each case. METHODS: We used Japan's administrative data to identify medical costs on a day-to-day basis. Data of 3136 patients with acute cerebral infarction from 14 medical institutions were included in the analyses. Using the data, we calculated the costs from the perspective of the third-party payer. Institutions were divided into three groups according to the distribution of medical costs in the first 2 days, and patient background, treatment process, and outcomes were compared across the groups. RESULTS: Medical cost was not necessarily intensively allocated during the early hospitalization period. Wide variations were observed in medical cost utilization patterns across institutions. The differences in medical cost for the initial hospitalization period appears to be more influenced by ICU utilization and management policies of institutions than the clinical condition of patients. CONCLUSIONS: We proposed a methodology that uses administrative claim data to examine management patterns of ischemic stroke. We believe that the use of our method, in conjunction with accurate and detailed clinical data, can help elucidate the relationship among acute-period medical resource utilization, process of care, and patient outcomes.

[Comparison of clinical efficacy and cost-quality of antihistamines in early treatment for Japanese cedar pollinosis].

BACKGROUND: Japanese cedar pollinosis (JCP) affects more than 16% of the Japanese population. The estimated direct and indirect costs for this disease totaled 286 billion yen in 1998. In JCP therapy, antihistamines are first line agents. It is well known that starting treatment for JCP with antihistamines before initial day of the pollen scattering can relieve nasal symptom severity during pollen season. The aim of this study is to assess the clinical efficacy and cost-quality of 7 major second-generation antihistamines in early treatment for Japanese cedar pollinosis (JCP). METHODS: Patients were randomly selected from 16 ENT clinical sites in Osaka and Wakayama between February 24 and March 8, 2003 (peak pollen season). Effectiveness was assessed using patient'ratings of nasal and ocular symptoms and overall assessment in their condition compared to previous season ones. Costs include direct costs of the drugs used for treatment to JCP from January to March. RESULTS: One hundred seventy-five patients who were treated with antihistamine monotherapy (azelastine: n=15, cetirizine: n=15, ebastine: n=36, epinastine: n=16, fexofenadine: n=16, loratadine: n=60, oxatomide: n=17) and 510 non-treatment patients were evaluated. Among 8 groups, there were significant differences in sneezing, rhinorrhea, ocular itching and overall health condition. However, among 7 monotherapy groups, there were no differences in each symptom or the overall assessment. In cost-quality analysis, there were significant differences in a cost for each effective patient (defined as those with improvement in their overall condition) among 7 drugs. The top three cost-efficacious drugs resulted in azelastine, loratadine and fexofenadine. CONCLUSION: These results show that there were no significant differences in clinical efficacy in early treatment for JCP among 7 antihistamines. But Japanese National Health Insurance drug price scheme led to significant differences in cost-quality.

[Impact of allergic rhinitis on work productivity: a pilot study].

BACKGROUND: Allergic rhinitis can interfere with cognitive function, can impair work productivity, and may cause work absences. In this study, we evaluated the impact of Japanese cedar pollinosis (JCP) on work productivity. METHODS: The study was conducted between February 24 and March 8, 2003 (peak pollen season), and 512 workers with JCP were enrolled. Study outcomes included self-reported work productivity (absenteeism and presenteeism) and quality of life (the Medical Outcomes Study Short Form-36). RESULTS: Most patients (91%) did not lose their work time due to JCP during the past 7 days. Approximately half of patients reported a 25% reduction in productivity compared with non pollination season. In multiple logistic regression analysis, the following factors were selected as independent risk factors for lost work time: duration of disease (adjusted odds ratio (aOR) = 0.658) and itching eyes (aOR = 1.552). Likewise, SF-36 PCS (aOR = 0.946), MCS (aOR = 0.927) and using pollinosis relief products (aOR = 2.020) were predictors of lost productivity. CONCLUSION: This study shows that we should pay more attention to ocular symptoms as well as nasal symptoms and improve patients' quality of life as soon as possible in order to reduce productivity losses.

[Regional comparison of patient-reported outcomes in Japanese cedar pollinosis].

BACKGROUND: There is little information about the relationship between local pollen counts and pollinosis symptoms of the local patients. In this study, we compared patient-reported outcomes (PROs) of Japanese cedar pollinosis (JCP) according to regions. METHODS: The study was conducted between February 24 and March 8, 2003 (peak pollen season), and 1200 patients were recruited from 15 ENT clinical sites in 4 regions : central Osaka (n = 576), southern Osaka (n = 195), northern Wakayama (n = 234), and southern Wakayama (n = 195). PROs consisted of nasal symptoms, ocular symptom, learning and work impairment, and QOL (SF-36). RESULTS: In non-treatment group, there were significant differences in ocular symptom and learning and work impairment among regions. On the other hand, patients with longer duration of treatment had better symptom relief regardless of pollen level in early treatment group. As to QOL, SF-36 summary scores did not differ among regions in both groups. CONCLUSION: This study shows that patients without early treatment seemed to be affected by pollen level on their ocular symptom and its related outcomes. In patients with early treatment, however, the treatment duration had bigger impact on PROs than the local pollen counts.

[Effects of drug adherence on patient outcomes to early treatment for Japanese cedar pollinosis].

Drug adherence is one of the important aspects in caring for patients with allergic rhinitis. To improve clinical efficacy of early treatment for Japanese cedar pollinosis (JCP), we evaluated the effect of drug adherence on patients' outcomes. Patients were randomly selected from 16 ENT clinical sites in Osaka and Wakayama between February 24 and March 8, 2003 (peak pollen season). Efficacy was assessed using patients' ratings of nasal and ocular symptoms and overall assessment in their condition compared with previous season ones. Costs include direct costs of the drugs used for treatment to JCP from January to February. Five hundred one patients taking early treatment were enrolled. Compared to low adherence patients, those who reported higher level of adherence significantly improved overall health condition, and achieved better symptom relief of rhinorrhea and nasal congestion. In multiple logistic regression analysis, the following factors were independent risk factors for low adherence: student (p=0.002), using OTC medications (p=0.006), and short-duration of medication (p=0.001). Low costs were also risk factor for low adherence. We conclude that taking medications for JCP for 22-28 days is the best way to enhance patients' outcomes.

[Willingness to pay for Japanese cedar pollinosis: comparison between pollination and non-pollination seasons].

Allergic rhinitis is not fatal illness, but its high prevalence and several symptoms result in substantial medical cost. There is increasing interest in the use of economic evaluations in healthcare; therefore, we investigated patients' willingness to pay (WTP) for prevention and cure from Japanese cedar pollinosis (JCP), and compared WTP values assessed in non-pollination season (June 1998) and pollination season (February-March 2003). Japanese economic woes got worse in 2003 than in 1998. Patients were randomly selected from ENT clinical sites in Osaka, 175 and 645 patients completed WTP questionnaire in 1998 and 2003, respectively. WTP value was lower in 2003 than in 1998, which related to part-time employees and housewives' reducing WTP. Declining WTP value did not associated with the differences in patient characteristics between 1998 and 2003 including age, duration of disease, nasal symptom severity and comorbid condition. These results show that we have to take employment status into account in economic evaluations. Decline in WTP for JCP in 2003 was strongly affected by Japanese sluggish economy, and the WTP seemed to be stable value in individual patients.

[Willingness to pay and quality of life in patients with Japanese-cedar pollinosis].

Seasonal allergic rhinitis (SAR) is one of the world's most common health problems because it's a high-cost, high-prevalence disease. In this study, we investigated patients' willingness to pay (WTP) for prevention and cure from most common SAR, Japanese-cedar pollinosis. Two hundred and forty patients with Japanese-cedar pollinosis, who visited 4 clinics in Osaka and were measured QOL by the SF-36 Questionnaire (Japanese version) during pollen season, were mailed WTP questionnaire in off-season in 1998. Completed questionnaires were sent back by 175 patients. Most patients (83.5%) were willing to pay less than 10,000 yen. Patients with longer duration of disease or severer nasal symptom tended to be more willing to pay. In contrast, no association was found between WTP and sex, age, occupation and comorbid condition. There were significant impairments in five of eight QOL dimensions in patients of Much-WTP in comparison with Less-WTP. Patients with mild symptom had significant higher medication cost than those with less mild symptom. We conclude that effective treatment, even if it costs much, can satisfy patients and may help to reduce indirect costs as well as to lessen the impact of Japanese-cedar pollinosis on QOL for both patient and society.