Cargando…

Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial

OBJECTIVES: In clinical trials, adverse events are usually self-reported but may be adjudicated if serious or of particular interest. After adjudicating cardiovascular events for a 5-year calcium supplement trial, we observed discrepancies between self-reported and verified events. We systematically...

Descripción completa

Detalles Bibliográficos
Autores principales:	Bolland, Mark J, Barber, Alan, Doughty, Robert N, Grey, Andrew, Gamble, Greg, Reid, Ian R
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2013
Materias:	Diabetes and Endocrinology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612743/ https://www.ncbi.nlm.nih.gov/pubmed/23512838 http://dx.doi.org/10.1136/bmjopen-2012-002334

Ejemplares similares

A comparison of adverse event and fracture efficacy data for strontium ranelate in regulatory documents and the publication record
por: Bolland, Mark J, et al.
Publicado: (2014)

Randomised trial assessing the impact of framing of fracture risk and osteoporosis treatment benefits in patients undergoing bone densitometry
por: Kalluru, Rama, et al.
Publicado: (2017)

Calcium supplements with or without vitamin D and risk of cardiovascular events: reanalysis of the Women’s Health Initiative limited access dataset and meta-analysis
por: Bolland, Mark J, et al.
Publicado: (2011)

Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis
por: Bolland, Mark J, et al.
Publicado: (2010)

Subgroup analysis for the risk of cardiovascular disease with calcium supplements
por: Radford, Loretta T, et al.
Publicado: (2013)

Comparative cardiovascular morbidity and mortality in patients taking different insulin regimens for type 2 diabetes: a systematic review
por: Price, Hilary I, et al.
Publicado: (2015)

Association between hyperglycaemic crisis and long-term major adverse cardiovascular events: a nationwide population-based, propensity score-matched, cohort study
por: Chang, Li-Hsin, et al.
Publicado: (2016)

Randomised controlled trial of vitamin D supplementation in sarcoidosis
por: Bolland, Mark J, et al.
Publicado: (2013)

Concordance of Results from Randomized and Observational Analyses within the Same Study: A Re-Analysis of the Women’s Health Initiative Limited-Access Dataset
por: Bolland, Mark J., et al.
Publicado: (2015)

Association of Pioglitazone With Major Adverse Cardiovascular Events, All-Cause Mortality, and Heart Failure Hospitalizations: A Systematic Review
por: Sheikh, Ibrahimkhalil M, et al.
Publicado: (2023)

The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA(1c) ≥64 mmol/mol: a group-based randomised controlled trial
por: Mohn, Jannike, et al.
Publicado: (2017)

A randomised investigation of journal responses to academic and journalist enquiry about possible scientific misconduct
por: Bolland, Mark J., et al.
Publicado: (2018)

Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes
por: Smits, Mark M, et al.
Publicado: (2015)

Fatty liver predicts the risk for cardiovascular events in middle-aged population: a population-based cohort study
por: Pisto, Pauliina, et al.
Publicado: (2014)

Examining the risk of depression or self-harm associated with incretin-based therapies used to manage hyperglycaemia in patients with type 2 diabetes: a cohort study using the UK Clinical Practice Research Datalink
por: Gamble, John-Michael, et al.
Publicado: (2018)

Reducing cardiovascular disease risk among families with familial hypercholesterolaemia by improving diet and physical activity: a randomised controlled feasibility trial
por: Kinnear, Fiona Jane, et al.
Publicado: (2020)

Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol
por: Angkurawaranon, Chaisiri, et al.
Publicado: (2020)

Does an intensive self-management structured education course improve outcomes for children and young people with type 1 diabetes? The Kids In Control OF Food (KICk-OFF) cluster-randomised controlled trial protocol
por: Price, Katherine J, et al.
Publicado: (2013)

Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial)
por: Færch, Kristine, et al.
Publicado: (2017)

Multiple risk factor control, mortality and cardiovascular events in type 2 diabetes and chronic kidney disease: a population-based cohort study
por: Hamada, Shota, et al.
Publicado: (2018)

Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T)
por: Papachristou Nadal, Iliatha, et al.
Publicado: (2021)

Design of a randomised controlled trial of the effects of empagliflozin on myocardial perfusion, function and metabolism in type 2 diabetes patients at high cardiovascular risk (the SIMPLE trial)
por: Jürgens, Mikkel, et al.
Publicado: (2019)

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care
por: Murray, Elizabeth, et al.
Publicado: (2017)

Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled trial protocol
por: Wilmot, Emma G, et al.
Publicado: (2021)

Indigenous health worker support for patients with poorly controlled type 2 diabetes: study protocol for a cluster randomised controlled trial of the Mana Tū programme
por: Selak, Vanessa, et al.
Publicado: (2018)

Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial
por: Mathiesen, Anne Sophie, et al.
Publicado: (2021)

Impact of polyethylene glycol loxenatide on cardiovascular outcomes in patients with type 2 diabetes: study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (BALANCE-3)
por: Xie, Yun, et al.
Publicado: (2023)

Is self-monitoring of blood glucose effective in improving glycaemic control in type 2 diabetes without insulin treatment: a meta-analysis of randomised controlled trials
por: Zhu, Hongmei, et al.
Publicado: (2016)

Rare Adverse Events Related to Nivolumab, an Immune Checkpoint Inhibitor: A Case Series
por: Ganta, Nagapratap, et al.
Publicado: (2022)

Quality of reports of investigations of research integrity by academic institutions
por: Grey, Andrew, et al.
Publicado: (2019)

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial
por: Ng'ang'a, Loise, et al.
Publicado: (2020)

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes
por: Coates, Elizabeth, et al.
Publicado: (2021)

A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes
por: Barthow, Christine, et al.
Publicado: (2022)

Comparison of the effects on cardiovascular events between use of metformin and dipeptidyl peptidase-4 inhibitors as the first-line hypoglycaemic agents in Japanese patients with type 2 diabetes mellitus: a claims database analysis
por: Nishimura, Rimei, et al.
Publicado: (2022)

Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial
por: Lind, Nanna, et al.
Publicado: (2021)

Sarcopenia as an important determinant for adverse outcomes in patients with pyogenic liver abscess
por: Liu, Li, et al.
Publicado: (2023)

Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial
por: Suhaimi, Aida Farhana, et al.
Publicado: (2020)

Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial
por: Brown, Sarah, et al.
Publicado: (2020)

Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial
por: Lewey, Jennifer, et al.
Publicado: (2017)

Use of multiple antidiabetic medications in patients with diabetes and its association with hypoglycaemic events: a case-crossover study in Jordan
por: Naser, Abdallah Y, et al.
Publicado: (2018)

Cannot write session to /tmp/vufind_sessions/sess_hgecael03e6hn4lkgclgsv0nhh