36 research outputs found

    Study protocol; thyroid hormone replacement for untreated older adults with subclinical hypothyroidism - a randomised placebo controlled trial (TRUST)

    Get PDF
    Background: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. Methods: Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. Discussion: This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. Trial registration: Clinicaltrials.gov NCT01660126; registered 8th June 2012

    Incorporating Baseline Outcome Data in Individual Participant Data Meta-Analysis of Non-randomized Studies.

    Get PDF
    Background In non-randomized studies (NRSs) where a continuous outcome variable (e.g., depressive symptoms) is assessed at baseline and follow-up, it is common to observe imbalance of the baseline values between the treatment/exposure group and control group. This may bias the study and consequently a meta-analysis (MA) estimate. These estimates may differ across statistical methods used to deal with this issue. Analysis of individual participant data (IPD) allows standardization of methods across studies. We aimed to identify methods used in published IPD-MAs of NRSs for continuous outcomes, and to compare different methods to account for baseline values of outcome variables in IPD-MA of NRSs using two empirical examples from the Thyroid Studies Collaboration (TSC). Methods For the first aim we systematically searched in MEDLINE, EMBASE, and Cochrane from inception to February 2021 to identify published IPD-MAs of NRSs that adjusted for baseline outcome measures in the analysis of continuous outcomes. For the second aim, we applied analysis of covariance (ANCOVA), change score, propensity score and the naïve approach (ignores the baseline outcome data) in IPD-MA from NRSs on the association between subclinical hyperthyroidism and depressive symptoms and renal function. We estimated the study and meta-analytic mean difference (MD) and relative standard error (SE). We used both fixed- and random-effects MA. Results Ten of 18 (56%) of the included studies used the change score method, seven (39%) studies used ANCOVA and one the propensity score (5%). The study estimates were similar across the methods in studies in which groups were balanced at baseline with regard to outcome variables but differed in studies with baseline imbalance. In our empirical examples, ANCOVA and change score showed study results on the same direction, not the propensity score. In our applications, ANCOVA provided more precise estimates, both at study and meta-analytical level, in comparison to other methods. Heterogeneity was higher when change score was used as outcome, moderate for ANCOVA and null with the propensity score. Conclusion ANCOVA provided the most precise estimates at both study and meta-analytic level and thus seems preferable in the meta-analysis of IPD from non-randomized studies. For the studies that were well-balanced between groups, change score, and ANCOVA performed similarly

    Kwaliteit van vleesvarkens met een hoog aflevergewicht

    No full text

    Kwaliteit van vleesvarkens met een hoog aflevergewicht

    Get PDF
    In Nederland is weinig bekend over de productie van zware vleesvarkens (I20- 160 kg levend gewicht). Er bestaat wel een specifieke markt voor deze categorie dieren. Door literatuuronderzoek en interviews zijn de slacht- en vleeskwaliteit van zware varkens vergeleken met die van varkens met een gangbaar gewicht

    Evaluation of the chronic disease self-management program (CDSMP) among chronically ill older people in the Netherlands

    Get PDF
    Many chronically ill older patients in the Netherlands have a combination of more than one chronic disease. There is therefore a need for self-management programs that address general management problems, rather than the problems related to a specific disease. The Chronic Disease Self-Management Program (CDSMP) seems to be very suitable for this purpose. In evaluations of the program that have been carried out in the United States and China, positive effects were found on self-management behaviour and health status. However, the program has not yet been evaluated in the Netherlands. Therefore, the aim of this study was to evaluate the short-term and longer-term effects of the program among chronically ill older people in the Netherlands. One hundred and thirty-nine people aged 59 or older, with a lung disease, a heart disease, diabetes, or arthritis were randomly assigned to an intervention group (CDSMP) or a control group (care-asusual). Demographic data and data on self-efficacy, self-management behaviour and health status were collected at three measurement moments (baseline, after 6 weeks, and after 6 months). The patients who participated rated the program with a mean of 8.5 points (range 0–10), and only one dropped out. However, our study did not yield any evidence for the effectiveness of the CDSMP on self-efficacy, self-management behaviour or health status of older patients in the Netherlands. Because the patients who participated were very enthusiastic, which was also indicated by very high mean attendance (5.6 out of 6 sessions) and only one dropout, it seems too early to conclude that the program is not beneficial for these patients.

    Evaluation of the chronic disease self-management program (CDSMP) among chronically ill older people in the Netherlands

    No full text
    Many chronically ill older patients in the Netherlands have a combination of more than one chronic disease. There is therefore a need for self-management programs that address general management problems, rather than the problems related to a specific disease. The Chronic Disease Self-Management Program (CDSMP) seems to be very suitable for this purpose. In evaluations of the program that have been carried out in the United States and China, positive effects were found on self-management behaviour and health status. However, the program has not yet been evaluated in the Netherlands. Therefore, the aim of this study was to evaluate the short-term and longer-term effects of the program among chronically ill older people in the Netherlands. One hundred and thirty-nine people aged 59 or older, with a lung disease, a heart disease, diabetes, or arthritis were randomly assigned to an intervention group (CDSMP) or a control group (care-as-usual). Demographic data and data on self-efficacy, self-management behaviour and health status were collected at three measurement moments (baseline, after 6 weeks, and after 6 months). The patients who participated rated the program with a mean of 8.5 points (range 0-10), and only one dropped out. However, our study did not yield any evidence for the effectiveness of the CDSMP on self-efficacy, self-management behaviour or health status of older patients in the Netherlands. Because the patients who participated were very enthusiastic, which was also indicated by very high mean attendance (5.6 out of 6 sessions) and only one dropout, it seems too early to conclude that the program is not beneficial for these patients.Self management Elderly Chronic disease Randomized trial The Netherlands
    corecore