Patient self-report allows collecting comprehensive data for the purpose of performing economic evaluations. The aim of the current study was to assess the feasibility, reliability and a part of the construct validity of a commonly applied questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder (TiC-P). Data were derived alongside two clinical trials performed in the Netherlands in patients with mental health problems. The response rate, average time of filling out the questionnaire and proportions of missing values were used as indicators of feasibility of the questionnaire. Test-retest analyses were performed including Cohen’s kappa and intra class correlation coefficients to assess reliability of the data. The construct validity was assessed by comparing patient reported data on contacts with psychotherapists and reported data on long-term absence from work with data derived from registries. The response rate was 72%. The mean time needed for filling out the first TiC-P was 9.4 minutes. The time needed for filling out the questionnaire was 2.3 minutes less for follow up measurements. Proportions of missing values were limited (< 2.4%) except for medication for which in 10% of the cases costs could not be calculated. Cohen’s kappa was satisfactory to almost perfect for most items related to healthcare consumption and satisfactory for items on absence from work and presenteeism. Comparable results were shown by the ICCs on variables measuring volumes of medical consumption and productivity losses indicating good reliability of the questionnaire. Absolute agreement between patient-reported data and data derived from medical registrations of the psychotherapists was satisfactory. Accepting a margin of +/− seven days, the agreement on reported and registered data on long-term absence from work was satisfactory. The validity of self-reported data using the TiC-P is promising. The results indicate that the TiC-P is a feasible and reliable instrument for collecting data on medical consumption and productivity losses in patients with mild to moderate mental health problems. Additionally, the construct validity of questions related to contacts with psychotherapist and long-term absence from work was satisfactory.

The 7-10-year psychological effects of presymptomatic testing for Huntington disease are described in 142 individuals and 104 partners. Questionnaires included the Beck Hopelessness Scale (A. T. Beck, A. Weissman, D. Lester, & L. Trexler, 1974), the Impact of Event Scale (M. J. Horowitz, N. Wilner. & W. Alvarez. 1979). and the General Health Questionnaire (D. P. Goldberg. 1972). Carriers and their partners were more distressed immediately after the test result, although their outlooks improved somewhat in the 2-3-year posttest period. However, they became more pessimistic thereafter, when approaching the age of onset. Carriers, who were lost to follow-up after disclosure of test results, reported more distress pretest than did retained carriers. This demonstrates that studies that report few harmful effects may have underestimated the real impact. Moreover, follow-up studies need to investigate time effects for longer than a few years.

Introduction We performed 4-year follow-up neuropsychological assessment to investigate cognitive decline and the prognostic abilities from presymptomatic to symptomatic familial frontotemporal dementia (FTD). Methods Presymptomatic MAPT (n = 15) and GRN mutation carriers (n = 31), and healthy controls (n = 39) underwent neuropsychological assessment every 2 years. Eight mutation carriers (5 MAPT, 3 GRN) became symptomatic. We investigated cognitive decline with multilevel regression modeling; the prognostic performance was assessed with ROC analyses and stepwise logistic regression. Results MAPT converters declined on language, attention, executive function, social cognition, and memory, and GRN converters declined on attention and executive function (p < 0.05). Cognitive decline in ScreeLing phonology (p = 0.046) and letter fluency (p = 0.046) were predictive for conversion to non-fluent variant PPA, and decline on categorical fluency (p = 0.025) for an underlying MAPT mutation. Discussion Using longitudinal neuropsychological assessment, we detected a mutation-specific pattern of cognitive decline, potentially suggesting prognostic value of neuropsychological trajectories in conversion to symptomatic FTD.

Non-adherence to disease-modifying antirheumatic drugs (DMARDs) hampers the targets of rheumatoid arthritis (RA) treatment, obtaining low disease activity and decreasing radiological progression. This study investigates if, and to what extent, non-adherence to treatment would lead to a higher 28-joint count disease activity score (DAS28) in the first year after diagnosis. Adult patients from an ongoing cohort study on treatment adherence were selected if they fulfilled the EULAR/ACR2010 criteria for RA, and were to start with their first DMARDs. Clinical variables were assessed at baseline and every 3 months. Non-adherence was continuously electronically measured and was defined as the proportion of days with a negative difference between expected and observed openings of the medication container out of the 3-month period before DAS28 measurement. Generalized linear mixed models were used to investigate whether the DAS28 related to non-adherence. Covariates included were age, sex, baseline DAS28, rheumatoid factor positivity, anti-cyclic citrullinated peptide antibodies (ACPA) positivity, anxiety, depression, weeks of treatment, number of DMARDs used, education level, use of subcutaneous methotrexate and biological use. One hundred and twenty patients met the inclusion criteria for RA. During the study period 17 patients became lost to follow-up. There was a decline in adherence over time for all DMARDs except for prednisone. Non-adherence is a predictor of disease activity in the first 6 months of therapy, adjusted for weeks of treatment, baseline DAS28, and baseline anxiety. Non-adherence relates to disease activity. Therefore, interventions towards enhancing adherence can improve disease outcome.

Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The aim of this study is to explore whether Cognitive Behavioural Therapy (CBT) by a mental health professional, working in a multidisciplinary team with a dietician and a physical therapist (a three-component intervention), is more effective for weight loss in the long term, within 12 months. We will also explore whether mobile phone applications are effective in supporting behavioural change and sustainable weight loss. The present study is a longitudinal randomized controlled trial (RCT) to study the effectiveness of a three-component 1-year cognitive-behavioural lifestyle intervention in overweight/obese women with PCOS. A total of 210 participants are randomly assigned to three groups: 1) CBT provided by the multidisciplinary team or; 2) CBT provided by the multidisciplinary team and Short Message Service (SMS) or; 3) usual care: encourage weight loss through publicly available services (control group). The primary aim of the 12-month intervention is to explore whether a three-component 1-year cognitive-behavioural lifestyle intervention is effective to decrease weight, when compared to usual care. Secondary outcomes include: the effect of the intervention on the PCOS phenotype, waist circumference, waist to hip ratio, ovulation rates, total testosterone, SHBG, free androgen index (FAI), AMH, hirsutism, acne, fasting glucose, blood pressure and all psychological parameters. Additionally, we assessed time to pregnancy, ongoing pregnancies, clinical pregnancies, miscarriages and birth weight. All outcome variables are measured at the start of the study, and again at 3 months, 6 months, nine months and 12 months. We expect that CBT provided by a multidisciplinary team, especially combined with SMS, is effective in developing a healthy lifestyle and achieving a long-term weight loss in women with PCOS. Losing 5– 10% body weight improves various PCOS characteristics. Consequently, we expect to show that CBT provided by a multidisciplinary team improves reproductive and metabolic outcomes, as well as quality of life, while at the same time being cost-effective. Registered at the Netherlands National Trial Register with number NTR2450 on August 2nd, 2010.

With expanding kidney transplantation programs, remaining hemodialysis patients are more likely to have a high comorbidity burden and may therefore be more prone to lose muscle mass. Our aim was to analyze risk factors for muscle loss in hemodialysis patients with high comorbidity. Fifty-four chronic hemodialysis patients (Charlson Comorbidity Index 9.0 ± 3.4) were followed for 20 weeks using 4-weekly measurements of lean tissue mass, intracellular water, and body cell mass (proxies for muscle mass), handgrip strength (HGS), and biochemical parameters. Mixed models were used to analyze covariate effects on LTM. LTM (−6.4 kg, interquartile range [IQR] −8.1 to −4.8), HGS (−1.9 kg, IQR −3.1 to −0.7), intracellular water (−2.11 L, IQR −2.9 to −1.4) and body cell mass (−4.30 kg, IQR −5.9 to −2.9) decreased in all patients. Conversely, adipose tissue mass increased (4.5 kg, IQR 2.7 to 6.2), resulting in no significant change in body weight (−0.5 kg, IQR −1.0 to 0.1). Independent risk factors for LTM loss over time were male sex (−0.26 kg/week, 95% CI −0.33 to −0.19), C-reactive protein above median (−0.1 kg/week, 95% CI −0.2 to −0.001), and baseline lean tissue index ≥10th percentile (−1.6 kg/week, 95% CI −2.1 to −1.0). Age, dialysis vintage, serum albumin, comorbidity index, and diabetes did not significantly affect LTM loss over time. In this cohort with high comorbidity, we found universal and prominent muscle loss, which was further accelerated by male sex and inflammation. Stable body weight may mask muscle loss because of concurrent fat gain. Our data emphasize the need to assess body composition in all hemodialysis patients and call for studies to analyze whether intervention with nutrition or exercise may curtail muscle loss in the most vulnerable hemodialysis patients.