Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).

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. 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. 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. Clinicaltrials.gov NCT01660126 ; registered 8th June 2012

CHANGE IN N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE LEVELS IN OLD AGE: THE LEIDEN 85-PLUS STUDY

Pathophysiology, epidemiology and therapy of agein

Prescribing and deprescribing antihypertensive medication in older people by Dutch general practitioners: a qualitative study

Contains fulltext : 193047.pdf (publisher's version ) (Open Access

Change in calculated cardiovascular risk due to guideline revision: A cross-sectional study in the Netherlands

Contains fulltext : 152010.pdf (Publisher’s version ) (Closed access)BACKGROUND: Guidelines and accompanying risk charts concerning cardiovascular risk management (CVRM) are regularly revised worldwide. OBJECTIVE: To evaluate whether revision of the Dutch CVRM guideline has led to the reclassification of patients and, accordingly, to changes in drug recommendations. METHODS: All medical records (year 2011) of patients aged 40-65 years with no history of cardiovascular disease (CVD) but using antihypertensive and/or lipid-lowering drugs, were selected from the Registration Network of General Practices associated with Leiden University Medical Center. Multiple imputation techniques for missing determinants were used. The individual cardiovascular risk was calculated and the resulting drug recommendation was assessed according to both the 2006 and 2012 versions of the guideline. RESULTS: In total, 2075 patients were selected, of whom 1248 fulfilled the guideline criteria (systolic blood pressure 115-180 mmHg and total cholesterol/high-density-lipoprotein-cholesterol ratio 3.5-8). According to the 2012 guideline, 58.2% of the patients had low risk and 249 patients (20.0%) shifted to a different risk category. For 150 of these patients (12.0%), this category shift implied a shift in drug recommendation. The probability of shifting in drug recommendation increased with increasing age, cholesterol level, and blood pressure, and by being male. CONCLUSION: Guideline revision may have important implications: based on identical values for risk factors, according to the latest revision of the Dutch CVRM guideline 20% of patients shifted in risk category and 12% of the patients shifted in drug recommendation

VARIATION IN PHYSICIANS' DECISIONS ON ANTIHYPERTENSIVE TREATMENT IN OLDEST-OLD AND FRAIL INDIVIDUALS ACROSS 29 COUNTRIES

Geriatrics in primary carePrevention, Population and Disease management (PrePoD)Public Health and primary car