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BACKGROUND: Localized prostate cancer (PCa) treatments provide high survival rates, with patients often surviving a decade or longer after treatment. Therefore, treatment options are progressively based on quality of life. The objective of this research was to investigate magnitude of response shift (RS) in health-related quality of life (HRQOL) responses in men with clinically localized PCa using a generic questionnaire and a disease-specific questionnaire in an observational longitudinal patient registry study. PATIENTS AND METHODS: A cohort study was conducted using the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database. Patients were annually surveyed using the Medical Outcomes Study Questionnaire Short Form 36 (SF-36) and the UCLA Prostate Cancer Index (PCI) HRQOL measures. A total of 3161 active patients were eligible for a one-off supplemental study asking retrospective HRQOL scores (then-test). We calculated RS, observed change, and RS adjusted change. Statistical difference was determined by t test. RESULTS: Patients consistently reported higher recalled pretreatment HRQOL compared to baseline scores for SF-36 and PCI, confirming the existence of a RS (P < .05). On average, PCI demonstrated larger RS by a factor of 2 than SF-36. More specific, RS was greater especially in SF-36 physical domains compared to mental health items. PCI measured PCa-specific physical adverse effects only. Patients whose cancer had recurred reported slightly lower SF-36 RS than those whose cancer had not recurred. CONCLUSION: RS occurrence was measured in both the disease-specific questionnaire and the generic HRQOL questionnaire, demonstrating continued low health and symptom scores after RS adjustment. Therefore, health professionals should adjust for this phenomenon when assessing patient's HRQOL treatment responses, and clinicians should address their continued sexual and urinary functional loss.

Lingyan You,1– 3 Hongtao Niu,1,2 Ke Huang,1,2 Fen Dong,1,2,4 Ting Yang,1,2 Chen Wang1,2,5 1Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, People’s Republic of China; 2National Clinical Research Center for Respiratory Diseases, Beijing, People’s Republic of China; 3Department of Pulmonary and Critical Care Medicine, Quanzhou First Hospital Affiliated Fujian Medical University, Quanzhou, Fujian, People’s Republic of China; 4Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, People’s Republic of China; 5Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of ChinaCorrespondence: Ting YangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Road, Chaoyang District, Beijing, 100029, People’s Republic of ChinaEmail zryyyangting@163.comChen WangChinese Academy of Medical Sciences and Peking Union Medical College, 9 Dongdan 3rd Alley, Dong Dan, Dongcheng, Beijing, 100730, People’s Republic of ChinaEmail cyh-birm@263.netPurpose: To identify clinical features and outcomes associated with pulmonary heart disease among patients with chronic obstructive pulmonary disease exacerbation (COPD), which may help reduce economic burden accrued over hospital stay and shorten length of stay (LOS).Patients and Methods: Totally, 4386 patients with acute exacerbation of COPD (AECOPD) classified into pulmonary heart disease (PHD) group and non-pulmonary heart disease group, were included from the ACURE registry, a prospective multicenter patient registry study. Clinical features and outcomes were compared between groups.Results: PHD patients had a more severe profile, including having higher scores of COPD assessment test and modified British Medical Research Council, worse lung function, more patients hospitalized more than once in the past year due to acute exacerbation of COPD, and more comorbidities. Furthermore, drug cost was higher and length of stay was longer in AECOPD patients with PHD.Conclusion: AECOPD patients with PHD had a more severe profile and worse clinical outcomes, including higher drug cost and longer LOS. PHD is an independent risk factor of drug cost and LOS. Complicated with PHD in COPD/AECOPD patients with PHD means heavier disease burden and worse prognosis. It merits further study to focus on PHD management in COPD/AECOPD patients.Keywords: chronic obstructive pulmonary disease, exacerbation, pulmonary heart disease, cost, length of stay

Background Diabetes is a common comorbidity among patients with exacerbation of chronic obstructive pulmonary disease (AECOPD). Diabetes has been reported to be associated with length of stay (LOS), death, and cost among AECOPD patients. However, most studies are retrospective or have small sample sizes. The association for cost has not been researched using diabetes as a main analytic factor. This study aimed to fill gaps mentioned above, to compare basic characteristics between the diabetic and non-diabetic group, and to detect associations between diabetes and clinical outcomes among patients hospitalized with AECOPD. Methods A total of 5334 AECOPD patients, classified into diabetic and non-diabetic group, were included from a prospective multicenter patient registry study. Generalized linear regression and logistic regression were separately used for the association between diabetes and direct hospitalization cost and the association between diabetes and LOS. Results Generally, diabetic patients had a more severe profile, including being older, more overweight or obese, having more former smokers, more emergency room visits in the past 12 months, and more comorbidities occurrence. Diabetic patients also had worse clinical outcomes, including higher cost and longer LOS. Additionally, the generalized linear regression indicated that the marginal mean cost difference between diabetic and non-diabetic patients was RMB (¥) 775.7. Conclusions AECOPD patients with comorbid diabetes had a more severe profile and higher direct hospitalization cost. Diabetes screening and integrated care programs might help reduce the heavy comorbidity and economic burden. Moreover, corticosteroids and metformin could be considered in the treatment of these patients. Trial registration Clinicaltrials.gov with the identifier NCT0265752.

Introduction: Roflumilast (ROF) is approved by the European Medicines Agency for maintenance treatment of severe COPD associated with chronic bronchitis and a history of frequent exacerbations as add on to inhalation treatment. The aim of the Patient registry of ROFlumilast In real LifE (PROFILE) study was to capture real-world data on the use of ROF in standard clinical practice. Methods: PROFILE (ClinicalTrials.gov:NCT02015767) was an observational, non-interventional, non-comparative, prospective patient registry study. Patients initiating ROF were identified and followed for 1 year according to usual clinical practice. Data were collected at 3-monthly intervals. The primary outcome was the incidence and frequency of COPD exacerbations over 1 year. Results: 1473 patients were enrolled from 5 European countries (Bulgaria, Germany, Greece, Norway and Slovakia), of whom 1222 had valid records. Patients were of median age 67 years, predominantly male (71.4%), had severe/very severe airflow limitation (71.4%/10.5%) and experienced a median of 2 COPD exacerbations (5–95% percentile 0–8) in the prior year. The most common reasons for starting ROF were COPD progression (62.7%), high exacerbation rate (56.5%) and inadequate response to therapy (46.4%). During the 1-year follow-up, 214 (17.5%) patients had 316 COPD exacerbations (69 had >1 exacerbation); the median number of exacerbations was 0 (5–95% percentile 0–2). There were no significant differences in exacerbation rate between COPD phenotypes (emphysema, chronic bronchitis and combined phenotype). Conclusions: These results suggest that the use of ROF in standard clinical practice may reduce the frequency of COPD exacerbations.

Background Thrombocytopenia is a common complication of critical illness and an independent risk factor for bleeding and death in the intensive care unit (ICU). Platelet transfusions are commonly used to improve platelet counts; however, the expected platelet increment from a transfusion in this setting has not been established. The objective of this study was to describe the frequency of platelet transfusion administration and their effect on platelet count increments in a large cohort of non-oncology critically ill adults. Methods We performed an analysis of a registry database, which was developed to capture clinical and laboratory data on all blood transfusions administered in 3 academic hospitals in Hamilton, Ontario, Canada. We included all patients ≥18 years who received one or more platelet transfusion during an ICU admission. Data validation was done by integrity checks with medical records and laboratory information system performed by a biostatistician. Non-transfused ICU patients were used as controls. The absolute increment in platelet count was calculated for each single platelet transfusion using the closest platelet count taken within 24 hours before the transfusion and 4-24 hours after the transfusion. Results Between April 2006 and October 2012, 33,222 patients were admitted to ICU, including 29,511 (88.8%) who did not have a diagnosis of cancer. Of those, 4,502 (15.3%) received one or more platelet transfusion during any ICU admission (n=4,690); 31.9% were female and median age at the time of first admission was 69 years (IQR 59-77). Among the 25,009 non-transfused patients admitted to ICU during the same period, 38.1% were female and the median age was 65 years (IQR 52–76). Median pre-transfusion platelet count was 87 x109/L (IQR 59-131) and a single platelet transfusion resulted in a median platelet count increment of 21 x109/L (IQR 6-40) as measured 6.7 hours (IQR 5.1-9.8) after the transfusion. There were 277 (25.4%) transfusions that yielded a platelet count increment of 5 x109/L or less. ICU mortality was 562/4,690 (12.4%) for patients who received a platelet transfusion, compared with 2,251/33,033(6.8%) for patients who were not transfused during their ICU stay. Summary/Conclusion Among this large cohort of non-oncology ICU patients, platelet transfusions were commonly administered for thrombocytopenia that was generally mild. In this setting one platelet transfusion resulted in a median platelet count rise of 21 x109/L. Many transfusion episodes yielded no appreciable increase in platelet count. Further studies are needed to determine the clinical effects of platelet transfusion in this setting controlling for confounding. Disclosures: Heddle: CIHR: Research Funding; Canadian Blood Services: Membership on an entity’s Board of Directors or advisory committees; Health Canada: Research Funding; Macopharma: Consultancy; ASH: Honoraria.