Development and Pretesting of a Questionnaire to Assess Patient Experiences and Satisfaction with Medications (PESaM Questionnaire)

Background: The aim of this study was to develop, together with the Lung Foundation Netherlands and Dutch Kidney Patients Association, patients and clinicians, a measure to evaluate patient experiences with the orphan drugs pirfenidone (for idiopathic pulmonary fibrosis [IPF]) and eculizumab (for atypical haemolytic uraemic syndrome [aHUS]), as well as a generic measure of patient experiences and satisfaction with medications. Methods: Development of the Patient Experiences and Satisfaction with Medications (PESaM) questionnaire consisted of four phases: literature review (phase I); focus groups and individual patient interviews (phase II); item generation (phase III); and face and content validity testing (phase IV). Literature review aimed to identify existing disease-specific and generic patient experience measures to provide guidance on the domains of medication use relevant to patients, the number of items and type of response categories, and to generate an initial pool of items. Subsequent focus groups and patient interviews were conducted to gain insight into the perceived effectiveness of the therapies, the bur

Sleep and energy intake in early childhood

Background And Objectives: Shorter sleep is associated with higher weight in children, but little is known about the mechanisms. The aim of this study was to test the hypothesis that shorter sleep was associated with higher energy intake in early childhood. Methods: Participants were 1303 families from the Gemini twin birth cohort. Sleep duration was measured using the Brief Infant Sleep Questionnaire when the children were 16 months old. Total energy intake (kcal per day) and grams per day of fat, carbohydrate and protein were derived from 3-day diet diaries completed by parents when children were 21 months old. Results: Shorter nighttime sleep was associated with higher total energy intake (P for linear trend=0.005). Children sleeping <10 h consumed around 50 kcal per day more than those sleeping 11–<12 h a night (the optimal sleep duration for children of this age). Differences in energy intake were maintained after adjustment for confounders. As a percentage of total energy intake, there were no significant differences in macronutrient intake by sleep duration. The association between sleep and weight was not significant at this age (P=0.13). Conclusions: This study provides the first evidence that shorter nighttime sleep duration has a linear association with higher energy intake early in life. That the effect is observed before emergence of associations between sleep and weight indicates that differences in energy intake may be a mechanism through which sleep influences weight gain

Different Mechanisms Underlie Post-menarchial Increase in Depression and Weight

Contains fulltext : 99254.pdf (publisher's version ) (Open Access)Background Depression and being overweight are correlated health problems in adulthood. Adolescence is a significant period for the onset and increase of depression and obesity, especially among girls. Pubertal development also occurs with concomitant increases in weight. Thus, it is not yet clear whether the association between depression and being overweight can be explained by pubertal development. Purpose We examined the association between depressive mood, body weight, and pubertal status in adolescent girls. Method The design was cross-sectional. In 962 young adolescent Dutch girls (age range, 11.9-15.9) weight and height measurements were used to calculate height, age, and gender-standardized body weight (zBMI). Questionnaires assessed depressive mood (the Center for Epidemiological Studies-Depression, CES-D, inventory) and menarcheal status (pre or post). Results The correlation between menarcheal status and body weight (r = 0.34, p < 0.001) was not affected by depressive mood, and the correlation between menarcheal status and depressive mood (r = 0.20, p < 0.001) was not affected by body weight. A small correlation between depressive mood and body weight (r = 0.12, p < 0.01) largely disappeared after controlling for menarche. Conclusion Menarcheal status largely explains the association between weight and depression. It is independently associated with both BMI and depression, suggesting that different mechanisms underlie the post-menarcheal increased prevalence of depression and overweight.6 p

Metabolic Engineering of Potato Carotenoid Content through Tuber-Specific Overexpression of a Bacterial Mini-Pathway

BACKGROUND: Since the creation of “Golden Rice”, biofortification of plant-derived foods is a promising strategy for the alleviation of nutritional deficiencies. Potato is the most important staple food for mankind after the cereals rice, wheat and maize, and is extremely poor in provitamin A carotenoids. METHODOLOGY: We transformed potato with a mini-pathway of bacterial origin, driving the synthesis of beta-carotene (Provitamin A) from geranylgeranyl diphosphate. Three genes, encoding phytoene synthase (CrtB), phytoene desaturase (CrtI) and lycopene beta-cyclase (CrtY) from Erwinia, under tuber-specific or constitutive promoter control, were used. 86 independent transgenic lines, containing six different promoter/gene combinations, were produced and analyzed. Extensive regulatory effects on the expression of endogenous genes for carotenoid biosynthesis are observed in transgenic lines. Constitutive expression of the CrtY and/or CrtI genes interferes with the establishment of transgenosis and with the accumulation of leaf carotenoids. Expression of all three genes, under tuber-specific promoter control, results in tubers with a deep yellow (“golden”) phenotype without any adverse leaf phenotypes. In these tubers, carotenoids increase approx. 20-fold, to 114 mcg/g dry weight and beta-carotene 3600-fold, to 47 mcg/g dry weight. CONCLUSIONS: This is the highest carotenoid and beta-carotene content reported for biofortified potato as well as for any of the four major staple foods (the next best event being “Golden Rice 2”, with 31 mcg/g dry weight beta-carotene). Assuming a beta-carotene to retinol conversion of 6∶1, this is sufficient to provide 50% of the Recommended Daily Allowance of Vitamin A with 250 gms (fresh weight) of “golden” potatoes

Validity of the Patient Experiences and Satisfaction with Medications (PESaM) Questionnaire

Background: This study assessed the validity and reliability of the generic module of the recently developed Patient Experiences and Satisfaction with Medications (PESaM) questionnaire in a sample of patients in the Netherlands. Methods: The generic module of the PESaM questionnaire consists of 18 items related to the domains effectiveness, side effects and ease of use of medications. It assesses patients’ experiences regarding the impact of the medication on daily life, health and satisfaction. In 2017, the PESaM questionnaire was sent out to idiopathic pulmonary fibrosis patients using pirfenidone or nintedanib, atypical haemolytic uraemic syndrome patients receiving eculizumab and patients using tacrolimus after kidney transplantation. Mean scores for each domain were calculated applying a scoring algorithm. Construct validity and reliability were assessed using recommended methods. Results: 188 participants completed the generic module, of whom 48% used pirfenidone, 36% nintedanib, 11% tacrolimus and 5% eculizumab. The generic module has good structural properties. Internal consistency values of the domains were satisfactory (i.e. Cronbach’s coefficient alpha above 0.7). Confirmatory factor analysis provided further evidence for construct validity, with good convergent and discriminant validity. The PESaM questionnaire also showed different scores for patients using different medications, in line with expectations, and was therefore able to differentiate between patient groups. Test–retest reliability of the items and domains were rated as moderate to fair (i.e. intraclass coefficients ranged between 0.18 and 0.76). Conclusions: The PESaM questionnaire is a unique patient-reported outcome measure evaluating patient experiences and satisfaction with medications. It has been developed in conjunction with patients, ensuring coverage of domains and issues relevant from the patient’s perspective. This study has shown promising validity of the generic module of the PESaM questionnaire. Further research is recommended to assess reliability in greater detail as well as the responsiveness of the measure. Trial registration: The study