Cluster Randomized Controlled Trial on the Effects of 12 Months of Combined Exercise Training during Hemodialysis in Patients with Chronic Kidney Disease-Study Protocol of the Dialysis Training Therapy (DiaTT) Trial.

Patients with chronic kidney disease (CKD) on hemodialysis (HD) experience treatment-related immobility and physical deconditioning, which is responsible for an increased risk of frailty and a high burden of multi-morbidity. Exercise has been shown to counteract this vicious cycle; however, its effectiveness has only been investigated in small cohorts. Therefore, the objective of the Dialysis Training Therapy (DiaTT) trial will be to assess the effects of a 12-month intradialytic exercise program on physical functioning, frailty and health economics in a large cohort of HD patients in a real-world setting. DiaTT will be a prospective, cluster-randomized (1:1), controlled, multi-center, interventional clinical trial across 28 dialysis units, aiming at the recruitment of >1100 CKD patients on HD. The intervention group will receive 12 months' intradialytic exercise (combined aerobic and resistance training), whereas the usual care group will not receive intervention. The primary endpoint will be a change on the sit-to-stand test (STS60) result between baseline and 12 months. Secondary endpoints will include physical functioning, frailty, quality of life, 3-point MACE, hospitalizations, survival, quality of HD, health literacy and health care costs. By including almost as many patients as previously investigated in smaller trials, DiaTT will be the largest randomized, controlled trial assessing frailty, quality of life and mortality in the field of nephrology.

The assessment of disability in children and adolescents with headache: adopting PedMIDAS in an epidemiological study.

OBJECTIVE: The study aimed at the assessment of disability in children with headache (n=1585, 11-14 yrs) from a randomly drawn population based sample. We explored the suitability of the PedMIDAS in epidemiological research by various indicators of response quality. Furthermore, predictors of disability were examined, as well as its association with measures of health care behaviour. METHODS: The PedMIDAS measures functional interference in different domains of life by asking the children for the number of days that their headache partially or totally interfered with their activities. RESULTS: The examination of response behaviour revealed a marked attrition of responses (missing, invalid) in two items. As a consequence, the total score for disability could not be obtained for about 25% of the children. Analysis of homogeneity of the PedMIDAS items revealed low item/total correlations in two items. The grading of disability resulted in 81.2% of all children with headache showing no or low disability. Only 1.4% was "severely" disabled. Disability was predicted by frequency, type and intensity of headache. From all psychological variables only dysfunctional stress coping was significantly associated with disability. Disability itself was significantly associated with medical consultation. CONCLUSIONS: Suitability of the PedMIDAS for epidemiological research was supported, however with a caveat and recommendations for item revision. Severe disability due to headache was rare in the studied unselected sample when defined by behavioural interference. It is suggested to explore the construct of disability by a multi-method approach, including further instruments assessing headache related distress, (respectively) quality of life.

Agreement of parents and children on characteristics of pediatric headache, other pains, somatic symptoms, and depressive symptoms in an epidemiologic study.

BACKGROUND: The objective of the present study was to assess the concordance between parent and child report regarding different domains of pediatric health, headache in particular. In addition, the influence of potential moderator variables on the agreement between parents and children was examined. METHODOLOGY: In an epidemiologic study on a randomly drawn sample of households with at least 1 child in the family between 7 and 14 years of age (community registries), various pediatric health disturbances (headache, other pains, somatic symptoms, and depression/anxiety) were assessed via both child (from the age of 9 y on) and parent report (n=3461). RESULTS: A relatively high parent-child agreement (sigmaM=0.61) was found regarding the variable headache frequency, whereas consensus regarding other pains was, for the most part, markedly lower. The lowest agreement (sigmaM=0.27) was found for depression/anxiety symptoms. A moderator analysis (with age, sex, and parental headache) between child and parent failed to reveal significant differences regarding the degree of agreement between the 2 data sources. Children reported more frequent and more severe symptoms in all health domains. CONCLUSION: The examined potential moderator variables did not elucidate processes underlying the differences in child and parent agreement. There is no convincing evidence that the children's appraisal is less valid than their parents'. In summary, parents' reports cannot be viewed as a substitute for children's reports in pediatric pain and health assessment. Instead, each perspective represents a unique subjective reality and as such, both are of importance for research on pediatric pain and other health variables.

Biopsychosocial correlates of headache: what predicts pediatric headache occurrence?

OBJECTIVE: The study aims at identifying biopsychosocial risk factors for headache in children and adolescents aged 9 to 14. METHODS: An epidemiological survey was conducted in a randomly drawn population sample of families with children in the above age group. Questionnaires were mailed to parents and children (n=6400), on whose data this report is based. The objective of the study was to establish a profile of risk factors regarding the occurrence of headache. Headache, as the criterion variable, was ranked according to its frequency in the last 6 months (no, rare, monthly, weekly). Independent variables came from 6 domains: health, socioeconomic, family, school, leisure/peers, and psychological factors. Data analysis was conducted via multinomial regression analyses in a 4-step strategy: (1) analysis of age and sex as control variables; (2) analysis of single variables from each of the 6 domains (controlled for age and sex); (3) domain analyses; and (4) comprehensive analysis including all significant variables from the domain analyses. RESULTS: Age and sex explained a small but significant proportion of the variance in headache frequency (3.5%). All health variables, several socioeconomic, and most family- and school-related as well as the psychological variables demonstrated a significant association with the criterion in the single variable models. However, only a few of the variables related to leisure/peer activities reached significance. The domain model comprising health variables explained 27% of the variance, achieving the best model fit, followed by the psychological model with 13%. CONCLUSIONS: The comprehensive model was able to explain one third of the total variance in headache occurrence. Contrary to our hypothesis, the addition of psychosocial variables to health-related predictors did not markedly improve model fit.