Cargando…

The thresholds for statistical and clinical significance – a five-step procedure for evaluation of intervention effects in randomised clinical trials

BACKGROUND: Thresholds for statistical significance are insufficiently demonstrated by 95% confidence intervals or P-values when assessing results from randomised clinical trials. First, a P-value only shows the probability of getting a result assuming that the null hypothesis is true and does not r...

Descripción completa

Detalles Bibliográficos
Autores principales:	Jakobsen, Janus Christian, Gluud, Christian, Winkel, Per, Lange, Theis, Wetterslev, Jørn
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2014
Materias:	Correspondence
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4015863/ https://www.ncbi.nlm.nih.gov/pubmed/24588900 http://dx.doi.org/10.1186/1471-2288-14-34

Ejemplares similares

Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods
por: Jakobsen, Janus Christian, et al.
Publicado: (2014)

When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts
por: Jakobsen, Janus Christian, et al.
Publicado: (2017)

Power estimations for non-primary outcomes in randomised clinical trials
por: Jakobsen, Janus Christian, et al.
Publicado: (2019)

Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial
por: Jakobsen, Janus Christian, et al.
Publicado: (2014)

‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial
por: Jakobsen, Janus Christian, et al.
Publicado: (2012)

Trial Sequential Analysis in systematic reviews with meta-analysis
por: Wetterslev, Jørn, et al.
Publicado: (2017)

Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants
por: Olsen, Markus Harboe, et al.
Publicado: (2023)

Predictors for major cardiovascular outcomes in stable ischaemic heart disease (PREMAC): statistical analysis plan for data originating from the CLARICOR (clarithromycin for patients with stable coronary heart disease) trial
por: Winkel, Per, et al.
Publicado: (2017)

Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials
por: Jørgensen, Caroline Kamp, et al.
Publicado: (2023)

Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
por: Riberholt, Christian Gunge, et al.
Publicado: (2021)

Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial
por: Carranza, Christian L., et al.
Publicado: (2022)

The Effects of Centralised and Specialised Intervention in the Early Course of Severe Unipolar Depressive Disorder: A Randomised Clinical Trial
por: Hansen, Hanne Vibe, et al.
Publicado: (2012)

Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials
por: Hemmingsen, Bianca, et al.
Publicado: (2011)

PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
por: Thybo, Kasper Højgaard, et al.
Publicado: (2017)

DEBATE-statistical analysis plans for observational studies
por: Hiemstra, Bart, et al.
Publicado: (2019)

Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus: a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials
por: Kähler, Pernille, et al.
Publicado: (2014)

Carotid endarterectomy with primary closure versus patch angioplasty in patients with symptomatic and significant stenosis: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials
por: Marsman, Martijn S, et al.
Publicado: (2019)

Effect of Chronic Escitalopram versus Placebo on Personality Traits in Healthy First-Degree Relatives of Patients with Depression: A Randomized Trial
por: Knorr, Ulla, et al.
Publicado: (2012)

Milrinone for cardiac dysfunction in critically ill adult patients: a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis
por: Koster, Geert, et al.
Publicado: (2016)

Deep brain stimulation for neurological disorders: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials
por: Petersen, Johanne Juul, et al.
Publicado: (2022)

The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders - design of two randomised clinical trials
por: Kessing, Lars Vedel, et al.
Publicado: (2011)

An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial
por: Olsen, Markus Harboe, et al.
Publicado: (2021)

Prothrombin complex concentrate versus placebo, no intervention, or other interventions in critically bleeding patients associated with oral anticoagulant administration: a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis
por: Ovesen, Christian, et al.
Publicado: (2018)

Digoxin for atrial fibrillation and atrial flutter: A systematic review with meta-analysis and trial sequential analysis of randomised clinical trials
por: Sethi, Naqash J., et al.
Publicado: (2018)

Social-Skills and Parental Training plus Standard Treatment versus Standard Treatment for Children with ADHD – The Randomised SOSTRA Trial
por: Storebø, Ole Jakob, et al.
Publicado: (2012)

Prognostic value of routinely available data in patients with stable coronary heart disease. A 10-year follow-up of patients sampled at random times during their disease course
por: Winkel, Per, et al.
Publicado: (2018)

Health apps targeting children with overweight—a protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials
por: Rashid, Rajeeb, et al.
Publicado: (2020)

Estimating required information size by quantifying diversity in random-effects model meta-analyses
por: Wetterslev, Jørn, et al.
Publicado: (2009)

False-positive findings in Cochrane meta-analyses with and without application of trial sequential analysis: an empirical review
por: Imberger, Georgina, et al.
Publicado: (2016)

Observed intervention effects for mortality in randomised clinical trials: a methodological study protocol
por: Hansen, Mathias Lühr, et al.
Publicado: (2023)

Duloxetine versus ‘active’ placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis
por: Siddiqui, Faiza, et al.
Publicado: (2021)

Melatonin for sleep disorders in children with neurodevelopmental disorders: protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials
por: Jørgensen, Caroline Kamp, et al.
Publicado: (2022)

Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction
por: Pels, Anouk, et al.
Publicado: (2019)

Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials
por: Marsman, Martijn S., et al.
Publicado: (2021)

Effects of adding ivabradine to usual care in patients with angina pectoris: a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis
por: Maagaard, Mathias, et al.
Publicado: (2020)

Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants
por: Hansen, Mathias Lühr, et al.
Publicado: (2019)

Detailed statistical analysis plan for the pulmonary protection trial
por: Buggeskov, Katrine B, et al.
Publicado: (2014)

Dopamine in critically ill patients with cardiac dysfunction: A systematic review with meta‐analysis and trial sequential analysis
por: Hiemstra, Bart, et al.
Publicado: (2018)

Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)
por: Juul, Sophie, et al.
Publicado: (2021)

Pulmonary artery perfusion versus no pulmonary perfusion during cardiopulmonary bypass in patients with COPD: a randomised clinical trial
por: Buggeskov, Katrine B, et al.
Publicado: (2016)

Cannot write session to /tmp/vufind_sessions/sess_co8vdhuji5ln87vb0sicgtdmqd