Five‐year follow up of a low glycaemic index dietary randomised controlled trial in pregnancy—no long‐term maternal effects of a dietary intervention

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

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Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽

10.1136/bmjopen-2020-044219 ◽

2021 ◽

Vol 11 (5) ◽

pp. e044219

Author(s):

J X Harmeling ◽

Kevin Peter Cinca ◽

Eleni-Rosalina Andrinopoulou ◽

Eveline M L Corten ◽

M A Mureau

Keyword(s):

Randomised Controlled Trial ◽

Breast Reconstruction ◽

Controlled Trial ◽

Capsular Contracture ◽

Tissue Expander ◽

Complication Rates ◽

Two Stage ◽

Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

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Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial

The Lancet ◽

10.1016/s0140-6736(21)00731-5 ◽

2021 ◽

Author(s):

Usha Menon ◽

Aleksandra Gentry-Maharaj ◽

Matthew Burnell ◽

Naveena Singh ◽

Andy Ryan ◽

...

Keyword(s):

Ovarian Cancer ◽

Cancer Screening ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Ovarian Cancer Screening ◽

Long Term Follow Up ◽

Randomised Controlled ◽

The Uk

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Long-term outcome of two forms of randomised benzodiazepine discontinuation

The British Journal of Psychiatry ◽

10.1192/bjp.bp.105.012039 ◽

2006 ◽

Vol 188 (2) ◽

pp. 188-189 ◽

Cited By ~ 19

Author(s):

R. C. Oude Voshaar ◽

W. J. M. J. Gorgels ◽

A. J. J. Mol ◽

A. J. L. M. Van Balkom ◽

J. Mulder ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Term Outcome ◽

Long Term Outcome ◽

Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

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