包括的尺度で評価した肺結核後遺症患者の健康関連quality of life

Commentary--goodbye M(C)ID! Hello MID, where do you come from?

To assess the impact of delay in emergency department (ED) on outcome of critically ill patients admitted to the medical intensive care unit (MICU). Outcome was defined as hospital mortality and as health-related quality of life (HRQoL) at 6 months after intensive care assessed by the 15D measure. The 15D is a generic, 15-dimensional, standardized measure of HRQoL. We hypothesized that prolonged stay in the ED is related to worse outcome. A prospective follow-up cohort study in university hospital. All consecutive 1675 patients admitted to the MICU between July 2002 and June 2004. The 15D questionnaire was mailed to all patients alive at 6 months after admission. Of all MICU patients, 64% were admitted from ED. The mean length of stay in the ED was 6.2 h (95%CI 5.9-6.5 h). The hospital mortality rate was 24.4% (20.0% in the ED vs. 33.0% in the non-ED cohort, P < 0.001) and it was associated with higher age and degree of physiological derangement at admission. Neither the length of ED stay was associated with hospital mortality (P = 0.82) nor with HRQoL at 6 months after MICU admission (P = 0.34). Altogether, HRQoL at 6 months was significantly lower compared with the age- and sex-matched general population (P < 0.001). In a university hospital, the length of ED stay was not associated with the outcome of critically ill medical patients. However, we feel that the effect of ED treatment and delay on outcome and outcome prediction in the critically ill patients deserves further evaluation.

Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) are intestinal conditions perceived differently by patients and physicians.The former is considered an organic disease in which stress or psychologic factors are usually considered secondary to the disease.The latter is considered a functional disorder in which symptoms are thought to be secondary to abnormal perceptions of normal gastrointestinal function.In this study, Pace et al. compared the impact of these two conditions on health-related quality of life (HRQOL), psychologic profiles, and perceived burden of stressful life events.Eighty patients with IBD and 85 with IBS completed assessment tools including the SF-36 (HRQOL), SCL-90 (psychologic profiles), and the Holmes and Rahe schedule (assessment of stressful life events).HRQOL was similarly reduced in both IBS and IBD (58.2 + 16.1 and 56.4 + 22.3, P < 0.05) when compared with established norms.The severity of psychologic symptoms was not statistically different between patients with IBD and those with IBS, as shown by SCL-90 mean scores of 0.89 + 0.45 versus 0.83 + 0.48, respectively (P < 0.05).Severity of recent stressful life events was perceived as higher by patients with IBS than by those with IBD (110 + 110.2 v 61.6 + 78.8, P < 0.05).The authors conclude that patients with IBS from their referral center have reduced HRQOL and a level of psychologic distress comparable to that of age-matched patients with IBD. Comment:The importance of HRQOL is being increasingly recognized in gastrointestinal disorders (1).HRQOL is multidimensional, including measures of physical, social, and psychologic function.IBD has been extensively evaluated in the HRQOL literature.There is now considerable evidence, using generic and disease-specific instruments, that patients with IBD have impaired HRQOL compared with healthy controls and that HRQOL decreases with more severe disease (2).Using a generic instrument (SF-36) validated for use in IBD and IBS, Pace et al. have shown that the relative impact on HRQOL in IBD and IBS is the same.Both disorders are associated with a lower quality measurement than seen in a healthy population.

Health-related quality of life (HRQoL) is increasingly used as an outcome parameter in haemophilia treatment. Currently, only generic HRQoL instruments are used, as disease-specific instruments for haemophilia are not available. The most widely used generic instruments are the descriptive SF-36 questionnaire and the EQ-5D questionnaire for assessment of utilities, ie preference-based HRQoL. Results of both instruments show significant correlation. All haemophilia prophylaxis studies using HRQoL as an outcome report a decreased HRQoL compared with the general population, a positive effect of prophylactic treatment and a negative effect of age. Generic instruments for measuring HRQoL are able to pick up differences between groups of patients with haemophilia and enable us to make comparisons across diseases. However, in order to establish the optimal treatment strategy for severe haemophilia, further information is needed on the long-term effects of different strategies on HRQoL. In addition, haemophilia-specific HRQoL instruments should be developed in order to provide detailed information for adjustment and evaluation of treatment in individual patients.

Background: Health related Quality of Life (HRQOL) is a patient reported outcome (PRO) used to evaluate clinical trials in various diseases. Health economic decisions are often based on HRQOL data, especially where the disease of interest is a chronic non life-threatening condition. Since there is no disease-specific HRQOL instrument to assess the impairments of patients with hand eczema (HE) we set out to develop an instrument to assess HE-specific HRQOL. The development process was done in an international group in order to receive an instrument which works in a culturally equivalent manner in different countries. Here we present the validation study of the German language version of the Quality of Life in hand eczema Questionnaire (QOLHEQ). Methods: The QOLHEQ was assessed up to three times in n = 316 HE patients. To explore construct validity we additionally assessed dermatology-specific (Dermatology Life Quality Index (DLQI) and Skindex-17) and generic (EuroQol -5 Dimensions (EQ -5D) HRQOL-instruments, a physician global assessment (PGA) of the HE and the disease severity as rated by the patient. The psychometric properties of the QOLHEQ were assessed using the Rasch model for each of the four subscales (symptoms, emotions, functioning and treatment/prevention) and a structural equation model to confirm the multi-dimensional structure of the QOLHEQ. We used several indices to test the responsiveness ofthe instrument. The analyses were done using AMOS 20, SPSS 20 and Rumm2030, Results: The study population was aged18 to 81 years (Mean: 46.7, SD 12.9), 45.9% were males. The PGA was normally distributed across the sample. After minor adaptations in the coding of two items all four subscales showed neither violations nor significant misfit to the Rasch model. The data revealed also a good fit to the structural equation model with HRQOL as primary construct and the four subscales as 2nd order factors. As expected the QOLHEQ showed a strong correlation with the dermatology-specific instruments (DLQI: r = 0.75 Skindex-17: r = 0.85) and a medium correlation with the EQ-5D (r =-0.51), the PGA (r = 0.34) and the disease severity reported by the patient (r = 0.59). The sensitivity to change of the QOLHEQ was superior compared with the other HRQOL-instruments as indicated by various responsiveness indices. Discussion: We have successfully developed and validated a diseases-specific HRQOL-instrument for HE. The QOLHEQ consists of 30 items assessing four relevant domains of HRQOL in HE patients and is ready to use in the German version. It's psychometric properties and responsiveness make it superior in assessing HRQOL in HE patients compared to other skin-disease specific or generic instruments. Other language versions (English, Danish, Finish, Japanese, Swedish and Turkish) will be available soon enabling scientists to compare their HRQOL data across countries.

Pneumonectomy: Post-operative quality of life and lung function

Health-related quality of life (HRQoL) in German early benefit assessment: The importance of disease-specific instruments

478 Background: HRQOL outcomes are increasingly used to guide patient-centered care and health policy decisions, especially when treatment has a limited impact on survival. Our aim was to systematically evaluate the quality of HRQOL reporting in phase III RCTs of mPCa and mUC. Methods: A systematic literature review identified phase III RCTs evaluating palliative systemic therapies for castrate sensitive or castrate resistant mPCa (excluding androgen-deprivation therapy) and mUC, published in English between 1985 and 2018. Supplementary material and companion publications on HRQOL were also reviewed. RCTs reporting HRQOL outcomes were scored by the Minimum Standard Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials (range 0-11). Results: Of 44 RCTs in mPCa, 25 (56.8%) reported HRQOL outcomes. BPI-SF or BPI (14 RCTs) and McGill-Melzack pain questionnaire (6 RCTs) were the most commonly used generic instruments, whereas FACT-P (16 trials), validated in advanced PCa, was the most commonly used disease-specific instrument. Average score of HRQOL reporting in mPCa was 6.7. Of 21 RCTs in mUC, 7 (33.3%) reported HRQOL. EORTC QLQ-C30 (6 RCTs) was the most commonly used generic instrument. Only 1 trial used a disease-specific instrument, FACT-BL, which lacks validation in mUC. Average score in mUC was 6.6. Conclusions: Robust HRQOL data from phase III RCTs in mPCa and mUC remain limited, and most HRQOL reports had methodologic shortcomings. Although the disease-specific FACT-P questionnaire being used is validated in advanced PCa, mUC RCTs have yet to use a culturally validated instrument to assess HRQOL. Quality of HRQOL reporting has improved over time but needs to be better harmonized across trials. [Table: see text]

Health-related quality of life (HR-QoL) is impaired in patients with hereditary angioedema (HAE) but has not yet been satisfactorily described. To study HR-QoL in patients with HAE by combining different HR-QoL instruments with disease activity assessment. All adults in the Swedish HAE registry were invited to take part in this questionnaire study, which used the generic HR-QoL instruments, EuroQol 5 Dimensions 5 Level (EQ-5D-5L) and the RAND Corporation Short Form 36 (RAND-36), the disease-specific Angioedema Quality of Life instrument (AE-QoL), the recently introduced Angioedema Activity Score (AAS) form, and questionnaires on sick leave and prophylactic medication. Sixty-four of 133 adults (26 men, 38 women) between 18 and 91 years old responded. The most affected HR-QoL dimensions in the EQ-5D-5L were pain/discomfort and anxiety/depression; in the RAND-36, energy/fatigue, general health, pain; and, in the AE-QoL, fears/shame and fatigue/mood. Women had lower HR-QoL in the RAND-36 for general health and energy/fatigue (p < 0.05). Patients who reported any AAS of >0 had significantly impaired HR-QoL. There were significant associations (p < 0.05) between the AAS and EQ-5D-5L, between the AAS and all dimensions of the RAND-36 except physical function, and between the AAS and AE-QoL in all dimensions. Nine of 36 patients who reported sick leave during the previous 4 weeks had significantly impaired HR-QoL in all the instruments (p < 0.05). There was no significant difference in HR-QoL in the patients with and the patients without prophylactic medication, except for the nutrition dimension of the AE-QoL (p < 0.05). Comprehensive information is obtained by combining different HR-QoL instruments. Pain, anxiety/depression, and fatigue/mood are important aspects of HAE but the AE-QoL disregards pain. HR-QoL was not significantly affected by prophylaxis. Increased disease activity was associated with impaired HR-QoL, which justifies more active disease management.

Health Related Quality of Life for Monosymptomatic Enuretic Children and Their Mothers

Diabetic Retinopathy (DR) is a well-known consequence of long standing and poorly controlled Diabetes Mellitus (DM). Several studies have demonstrated both a qualitative and quantitative reduction in health related quality of life in persons with DR. But no such study has been done in the Indian population. To assess health related and vision related quality of life in people with DR. The present study included two groups of patients with Type 1 and Type 2 diabetes. Cases included 97 patients with DR. The control group (n=26) consisted of diabetic cases with no clinically detectable DR changes. After taking informed consent, health and vision related quality of life was assessed using National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25). Demographic information, social history and diabetic history were also obtained from all patients. DR was graded using the Early Treatment Diabetic Retinopathy Study (ETDRS) classification. Of the 97 cases with DR, 42.3% were females. Of the 26 controls, 53.8% were females. The mean±SD age in years of the cases was 55.09±9.56 and controls were 54.12±13.01. The mean±SD of DM in years for the cases was 10.98±5.62 and for controls was 6.69±2.29. There were statistically significant (p<0.001) lower VFQ-25 composite and sub scale scores of the cases when compared with controls. As the grade of DR increased, VFQ-25 sub-scale scores decreased and this was statistically significant for composite and all sub scales (p<0.005) except ocular pain. Mann-Whitney test Z-value was highest in general health, general vision, composite score and mental health. Quality of life was significantly lower in diabetics with DR when compared with those without DR with maximum effect seen on general health, general vision and mental health. Quality of life decreased as the duration of retinopathy and severity of retinopathy increased.

Health-related quality of life (HRQOL) is increasingly recognized as an important parameter in the assessment of the morbidity associated with obstructive sleep apnea (OSA). Generic and sleep disorder-specific instruments consistently demonstrate impairment in multiple domains of HRQOL in OSA, particularly in the domains of sleep, energy, fatigue, and vigilance. Sleep disorder-specific tools are potentially more sensitive than generic tools in describing HRQOL impairment in untreated OSA and treatment effects of continuous positive airway pressure (CPAP) and are increasingly being employed in clinical trials of OSA treatment. Severe OSA is generally associated with severe HRQOL impairment; however, studies do not consistently demonstrate a linear relationship between physiologic measures of OSA severity and measures of severity of HRQOL impairment. Excessive sleepiness, cognitive dysfunction, and psychological impairment are common measurable components of HRQOL impairment in OSA, particularly severe OSA, but the interactions among these and quality of life impairments measured by standard HRQOL instruments are not well studied. Therapeutic CPAP appears to broadly improve HRQOL domains in OSA, but substantial placebo effect has been demonstrated, suggesting that HRQOL impairment in OSA may be mediated by aspects of the disorder other than the physiologic effects of the OSA. Further randomized controlled trials should better elucidate the associations between physiologic impairment in OSA and HRQOL measures of interest to clinicians and researchers in this field.

Health-related quality of life (HRQOL) has emerged as a widely accepted measure to evaluate how chronic disease impacts on an individual's physical, social, and mental well-being. There is a paucity of data focusing on HRQOL in specific epilepsy syndromes and their associated needs. In this study our aim was to describe the comorbidities and disease-related predictors for HRQOL in Dravet syndrome, an epileptic encephalopathy, with defined genetic etiology. We anticipate that this will help us to better recognize and understand the needs of children and families and aid treatment planning in this severe epilepsy syndrome. One hundred sixty-three individuals with Dravet syndrome and their families participated in the study. Detailed clinical and demographic information was available for each case. HRQOL was evaluated with two epilepsy-specific instruments, the Impact of Pediatric Epilepsy Scale (IPES) and the Epilepsy & Learning Disabilities Quality of Life Questionnaire (ELDQOL); a generic HRQOL instrument; the Pediatric Quality of Life Inventory (PedsQL); and a behavioral screening tool, the Strength and Difficulties Questionnaire (SDQ). HRQOL was significantly lower for children with Dravet syndrome compared to normative data (p < 0.001). A cross-sectional evaluation of measures across different age groups revealed that PedsQL generic core and cognitive function scales decreased in older age categories, indicating worse HRQOL (p < 0.001). Assessment of epilepsy severity demonstrated that symptoms were rated very severe in 10 (6%) of 162 cases, somewhat severe in 78 (48%) of 162, moderate in 51 (32%) of 162, and mild in 23 (14%) of 162 cases. The epilepsy severity correlated significantly with the IPES total impact score (r = 0.466, p < 0.001, n = 162). The IPES total impact scores in the Dravet group (n = 162) were significantly higher than scores measured in the original validation sample of epileptic children with and without learning difficulties (± SD) (21.0 ± 8.7 vs. 11.6 ± 5.4, t = 8.95, p < 0.001, n = 46). On the SDQ, 35% of children scored in the abnormal range for "conduct problems," 66% for "hyperactivity/ inattention," and 76% for "peer relationships." Regression analysis revealed that young age at seizure onset (p = 0.019), presence of myoclonic seizures (p = 0.029), motor disorder (p = 0.048), learning difficulties (p = 0.002), epilepsy severity (p < 0.001), and behavioral difficulties (p < 0.001) each independently predicted poorer HRQOL. Behavioral problems such as hyperactivity/inattention were the strongest predictors of poorer HRQOL. This is the first comprehensive study of HRQOL in an etiologically well-defined epilepsy syndrome. HRQOL in Dravet syndrome depends on a series of independent factors including seizure control, behavior, cognitive, and motor problems. Identification of specific comorbidities in Dravet syndrome will facilitate a distinct and multidisciplinary approach to management, addressing seizure control, behavior problems, cognitive difficulties, and motor impairment.

IMPACT OF TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY ON QUALITY OF LIFE: A PROSPECTIVE RANDOMIZED TRIAL COMPARING 6 VERSUS 12 CORES

Expanded Prostate Cancer Index Composite for Clinical Practice: Development and Validation of a Practical Health Related Quality of Life Instrument for Use in the Routine Clinical Care of Patients With Prostate Cancer