Self-reported fatigue and physical function in late mid-life

Objective: To determine the association between the 5 sub-scales of the Multidimensional Fatigue Inventory (MFI-20) and physical function in late mid-life. Design: Cross-sectional study. Subjects: A population-based sample of adults who participated in the Copenhagen Aging and Midlife Biobank population cohort (n=4,964; age 49-63 years). Methods: Self-reported fatigue was measured using the MFI-20 comprising: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. Handgrip strength and chair rise tests were used as measures of physical function. Multiple logistic regression analyses were used to determine the associations between handgrip strength and the chair rise test with the MFI-20 subscales, adjusted for potential confounders. Results: After adjustments for potential confounders, handgrip strength was associated with physical fatigue (adjusted odds ratio (OR) 0.75 (95% confidence interval (CI) 0.66-0.86); p Conclusion: The present study supports the physiological basis of 4 subscales of the MFI-20. The association between fatigue and function was independent of gender

Establishing a composite endpoint for measuring the effectiveness of geriatric interventions based on older persons' and informal caregivers' preference weights:a vignette study

Background: The Older Persons and Informal Caregivers Survey Minimal Dataset's (TOPICS-MDS) questionnaire which measures relevant outcomes for elderly people was successfully incorporated into over 60 research projects of the Dutch National Care for the Elderly Programme. A composite endpoint (CEP) for this instrument would be helpful to compare effectiveness of the various intervention projects. Therefore, our aim is to establish a CEP for the TOPICS-MDS questionnaire, based on the preferences of elderly persons and informal caregivers. Methods: A vignette study was conducted with 200 persons (124 elderly and 76 informal caregivers) as raters. The vignettes described eight TOPICS-MDS outcomes of older persons (morbidity, functional limitations, emotional wellbeing, pain experience, cognitive functioning, social functioning, self-perceived health and self-perceived quality of life) and the raters assessed the general well-being (GWB) of these vignette cases on a numeric rating scale (0-10). Mixed linear regression analyses were used to derive the preference weights of the TOPICS-MDS outcomes (dependent variable: GWB scores; fixed factors: the eight outcomes; unstandardized coefficients: preference weights). Results: The mixed regression model that combined the eight outcomes showed that the weights varied from 0.01 for social functioning to 0.16 for self-perceived health. A model that included "informal caregiver" showed that the interactions between this variable and each of the eight outcomes were not significant (p > 0.05). Conclusion: A preference-weighted CEP for TOPICS-MDS questionnaire was established based on the preferences of older persons and informal caregivers. With this CEP optimal comparing the effectiveness of interventions in older persons can be realized

Clinimetric evaluation of a Satisfaction-with-Stroke-Care questionnaire

There is a lack of sound instruments for measuring patient satisfaction with stroke care. One self-report instrument comprising two subscales, satisfaction with inpatient care and satisfaction with care after discharge, has been validated, but only in the United Kingdom. In later studies, items have been added without further validation. Therefore, we tested this extended questionnaire (Satisfaction with Stroke Care questionnaire; SASC-19) for feasibility, reliability (homogeneity and test-retest agreement), and construct validity (convergent and divergent validity and factor analysis) in the Netherlands in 166 prospectively collected stroke patients living at home 6 months after discharge. To determine the testretest reliability, 51 patients completed the SASC-19 again two weeks after they first completed it. The response rate was 90%; the mean time needed to complete the SASC-19 was less than 10 minutes. Six items were omitted by more than 10% of the patients. Both subscales showed good homogeneity and almost perfect test-retest reliability (Cronbas alpha's > 0.80; Intraclass Correlation Coefficients > 0.80). The correlations with the General Satisfaction questionnaire (convergent validity) ranged between 0.33 and 0.55; those with the Barthel Index, the Hospital Anxiety and Depression Scale (HADS), and the Short Form 36 (SF-36) health survey questionnaire (divergent validity) ranged between 0.12 and 0.47. Factor analysis showed a total explained variance of 49%, which supports the subscale structure. We conclude that the SASC-19 is a reliable and valid instrument for measuring patient satisfaction with stroke care and it is easy to complete. The feasibility in terms of missing values is moderat

Regional differences in the use of out-patient services by stroke patients after hospitalisation

BACKGROUND: To improve the quality of life in stroke patients, outreach care programmes are developed and assessed for effectiveness. The generalisability of the trials' results is uncertain since information on the comparability of the conventional out-patient services is lacking. This study intended to assess the use of 11 types of conventional out-patient services by stroke patients in the United States and a predefined set of Western European countries. METHODS: Review of the literature from 1990 to 2001. RESULTS: We found 11 studies, which contained data on 1,875 patients of 6 countries. Large differences in the use of out-patient services within and between countries prohibited pooling of the data. CONCLUSIONS: The paucity of data on the use of conventional out-patient services by stroke patients and the regional differences found do not substantiate generalisability of the results from studies on outreach care for stroke patient

Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia: Comparisons Between Subgroups of Participants of the European First Episode Schizophrenia Trial (EUFEST)

Objective: Most randomized drug trials in schizophrenia exclude patients with such as suicidality or substance use, which may limit the generalizability of the results. We aimed to evaluate the generalizability of the results of these trials in participants of a randomized clinical trial with broad inclusion criteria. Method: In 50 sites in 14 countries, 498 with first-episode psychosis (DSM-IV nia, schizoaffective disorder, or schizophreniform disorder) were recruited between December 2002 and January 2006 in an open, randomized clinical drug trial with 12 months of follow-up. Baseline characteristics and follow-up data were compared between patients with versus patients without baseline suicidality and/or substance use. Results: Of the 489 participants with data on baseline suicidality and substance use, 153 (31%) patients were suicidal and/or using substances. Groups differed on only a few of the many baseline characteristics tested: comorbid patients were younger (25.1 vs 26.5 years of age; P Conclusions: Although it appears that the generalizability of antipsychotic treatment trials in first-episode patients is not seriously affected the exclusion of patients with suicidal symptoms and/or substance use, researchers should be cautious about the exclusion of such patients

Modified informed consent procedure: consent to postponed information

How do you obtain a valid assessment of subjective outcomes in a trial in which the participants cannot be blinded to the intervention? Bias is inevitable from unblinded patients, but trials that have not told patients about treatment in all arms have been heavily criticised. Asking participants to consent to postponed information could be a solutio