Validity of composite end points in clinical trials.

PubWeight™: 3.26‹?› | Rank: Top 1%

🔗 View Article (PMC 554039)

Published in BMJ on March 12, 2005

Authors

Victor M Montori1, Gaietà Permanyer-Miralda, Ignacio Ferreira-González, Jason W Busse, Valeria Pacheco-Huergo, Dianne Bryant, Jordi Alonso, Elie A Akl, Antònia Domingo-Salvany, Edward Mills, Ping Wu, Holger J Schünemann, Roman Jaeschke, Gordon H Guyatt

Author Affiliations

1: Department of Medicine, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.

Articles citing this

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ (2013) 9.01

A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med (2008) 5.11

Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ (2010) 3.46

Methodology for the development of antithrombotic therapy and prevention of thrombosis guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest (2012) 3.14

Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ (2007) 3.06

Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am (2008) 3.01

Hospital mortality: when failure is not a good measure of success. CMAJ (2008) 1.98

Cardiovascular effects of calcium supplementation. Osteoporos Int (2011) 1.96

The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol. Trials (2009) 1.92

Variable impact on mortality of AIDS-defining events diagnosed during combination antiretroviral therapy: not all AIDS-defining conditions are created equal. Clin Infect Dis (2009) 1.86

Addressing the future role of general practice at the 16th Nordic Congress in Copenhagen 2009: how can we ensure sustainable care in a complex world of evidence, context, organization, and personal care? Scand J Prim Health Care (2008) 1.58

Maastricht Delphi consensus on event definitions for classification of recurrence in breast cancer research. J Natl Cancer Inst (2014) 1.55

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes--individual patient data (IPD) meta-analysis and health economic evaluation. Syst Rev (2014) 1.44

Pharmacological prevention of serious anaphylactic reactions due to iodinated contrast media: systematic review. BMJ (2006) 1.41

Cardiovascular and Renal Outcomes of Renin-Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses. PLoS Med (2016) 1.40

In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med (2008) 1.26

Efficacy and tolerability balance of oxycodone/naloxone and tapentadol in chronic low back pain with a neuropathic component: a blinded end point analysis of randomly selected routine data from 12-week prospective open-label observations. J Pain Res (2016) 1.10

Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One (2013) 1.06

Glycemic Control for Patients With Type 2 Diabetes Mellitus: Our Evolving Faith in the Face of Evidence. Circ Cardiovasc Qual Outcomes (2016) 1.02

Methodologic issues in health informatics trials: the complexities of complex interventions. J Am Med Inform Assoc (2008) 1.01

Composite and surrogate outcomes in randomised controlled trials. BMJ (2007) 0.97

Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Crit Care (2006) 0.96

Waking up from the DREAM of preventing diabetes with drugs. BMJ (2007) 0.94

Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years. Stroke (2011) 0.89

The end point is just the beginning. J Diabetes Sci Technol (2011) 0.88

The value of health care--a matter of discussion in Germany. BMC Health Serv Res (2007) 0.85

Designing and analyzing clinical trials with composite outcomes: consideration of possible treatment differences between the individual outcomes. PLoS One (2012) 0.85

Selecting and measuring optimal outcomes for randomised controlled trials in surgery. Langenbecks Arch Surg (2014) 0.85

Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials. Crit Care (2011) 0.83

Testing for heterogeneity among the components of a binary composite outcome in a clinical trial. BMC Med Res Methodol (2010) 0.82

Misspecification of Cox regression models with composite endpoints. Stat Med (2012) 0.81

Importance of achieving the composite endpoints in diabetes. Indian J Endocrinol Metab (2013) 0.81

Methylprednisolone for the Treatment of Patients with Acute Spinal Cord Injuries: A Propensity Score-Matched Cohort Study from a Canadian Multi-Center Spinal Cord Injury Registry. J Neurotrauma (2015) 0.81

Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial. Trials (2011) 0.80

The role of surrogate endpoints in the evaluation of efficacy and safety of therapeutic interventions in diabetes mellitus. Rev Diabet Stud (2008) 0.80

Concordance of effects of medical interventions on hospital admission and readmission rates with effects on mortality. CMAJ (2013) 0.80

Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial. Intensive Care Med (2017) 0.80

Reassessing the benefits of statins in the prevention of cardiovascular disease in diabetic patients--a systematic review and meta-analysis. Rev Diabet Stud (2013) 0.79

Nocturnal oxygen therapy in patients with chronic obstructive pulmonary disease: a survey of Canadian respirologists. Can Respir J (2007) 0.79

Endpoint selection and relative (versus absolute) risk reporting in published medication trials. J Gen Intern Med (2011) 0.79

Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med (2017) 0.77

Comparative study of outcome measures and analysis methods for traumatic brain injury trials. J Neurotrauma (2015) 0.76

Beyond Composite Endpoints Analysis: Semicompeting Risks as an Underutilized Framework for Cancer Research. J Natl Cancer Inst (2016) 0.75

What's new in trial design: propensity scores, equivalence, and non-inferiority. J Extra Corpor Technol (2009) 0.75

Relationship between medication event rates and the Leapfrog computerized physician order entry evaluation tool. J Am Med Inform Assoc (2013) 0.75

Meaningful outcome measures in cardiac surgery. J Extra Corpor Technol (2014) 0.75

Fluid restriction and prophylactic indomethacin in extremely low birth weight infants. J Clin Neonatol (2012) 0.75

Clinical Relevance of Rehospitalizations for Unstable Angina and Unplanned Revascularization Following Acute Myocardial Infarction. J Am Heart Assoc (2016) 0.75

Understanding commonly encountered limitations in clinical research: an emergency medicine resident's perspective. Ann Emerg Med (2011) 0.75

Outcomes, outcomes, every where, nor any stop to think? J Gen Intern Med (2011) 0.75

Delphi-consensus weights for ischemic and bleeding events to be included in a composite outcome for RCTs in thrombosis prevention. PLoS One (2011) 0.75

What should urologists know about evidence-based medicine? Indian J Urol (2011) 0.75

End points in heart failure-are we doing it right? Eur J Clin Pharmacol (2017) 0.75

Win Ratio -An Intuitive and Easy-To-Interpret Composite Outcome in Medical Studies. Shanghai Arch Psychiatry (2017) 0.75

Articles by these authors

Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med (2013) 39.56

GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ (2008) 33.10

Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med (2008) 31.57

Grading quality of evidence and strength of recommendations. BMJ (2004) 26.08

An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med (2011) 22.39

Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. JAMA (2004) 22.38

Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med (2013) 17.37

De-ubiquitination and ubiquitin ligase domains of A20 downregulate NF-kappaB signalling. Nature (2004) 12.41

GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol (2010) 11.77

Adherence to antiretroviral therapy in sub-Saharan Africa and North America: a meta-analysis. JAMA (2006) 11.71

Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med (2013) 11.44

Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest (2012) 10.75

GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol (2011) 10.02

Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res (2002) 9.99

Adherence to HAART: a systematic review of developed and developing nation patient-reported barriers and facilitators. PLoS Med (2006) 8.57

Randomized trials stopped early for benefit: a systematic review. JAMA (2005) 8.43

Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med (2007) 8.33

Use of mental health services for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys. Lancet (2007) 8.24

Going from evidence to recommendations. BMJ (2008) 7.30

Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res (2004) 7.20

What is "quality of evidence" and why is it important to clinicians? BMJ (2008) 6.99

The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol (2010) 6.61

High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med (2013) 6.56

Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry (2007) 6.46

Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA (2008) 6.39

The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res (2010) 6.09

An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med (2015) 6.03

Cross-national prevalence and risk factors for suicidal ideation, plans and attempts. Br J Psychiatry (2008) 5.90

Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA (2010) 5.90

Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest (2012) 5.88

Effusive-constrictive pericarditis. N Engl J Med (2004) 5.82

Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol (2010) 5.80

GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology. J Clin Epidemiol (2010) 5.78

Probiotics for the prevention of Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Ann Intern Med (2012) 5.67

Comparison of mortality between private for-profit and private not-for-profit hemodialysis centers: a systematic review and meta-analysis. JAMA (2002) 5.57

Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest (2012) 5.57

An official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. Am J Respir Crit Care Med (2006) 5.29

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med (2015) 5.28

B cells promote insulin resistance through modulation of T cells and production of pathogenic IgG antibodies. Nat Med (2011) 5.16

Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ (2008) 5.16

GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). J Clin Epidemiol (2011) 5.10

Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest (2012) 5.02

A systematic review and meta-analysis of studies comparing mortality rates of private for-profit and private not-for-profit hospitals. CMAJ (2002) 4.84

Cost of disorders of the brain in Europe 2010. Eur Neuropsychopharmacol (2011) 4.63

Optimal search strategies for retrieving systematic reviews from Medline: analytical survey. BMJ (2004) 4.58

Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ (2004) 4.53

Cross-national epidemiology of DSM-IV major depressive episode. BMC Med (2011) 4.52

Comparisons of citations in Web of Science, Scopus, and Google Scholar for articles published in general medical journals. JAMA (2009) 4.48

Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry (2007) 4.46

Internet versus mailed questionnaires: a randomized comparison (2). J Med Internet Res (2004) 4.45

The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med (2009) 4.41

Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med (2013) 4.37

Need for expertise based randomised controlled trials. BMJ (2005) 4.34

Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol (2006) 4.32

An observational study of orthopaedic abstracts and subsequent full-text publications. J Bone Joint Surg Am (2002) 4.25

The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol (2010) 4.10

A memory retrieval-extinction procedure to prevent drug craving and relapse. Science (2012) 4.04

Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med (2014) 3.96

Combined corticosteroid and antiviral treatment for Bell palsy: a systematic review and meta-analysis. JAMA (2009) 3.81

A new 'mechanistic-practical" framework for designing and interpreting randomized trials. J Clin Epidemiol (2008) 3.75

The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Control Clin Trials (2002) 3.62

GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol (2010) 3.60

GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol (2013) 3.58

Physicians' and patients' choices in evidence based practice. BMJ (2002) 3.57

The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc (2009) 3.55

GRADE guidelines 6. Rating the quality of evidence--imprecision. J Clin Epidemiol (2011) 3.54

Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses. BMJ (2010) 3.54

Long-term vasodilator therapy in patients with severe aortic regurgitation. N Engl J Med (2005) 3.52

The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med (2010) 3.47

Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev (2011) 3.44

GRADE guidelines: 5. Rating the quality of evidence--publication bias. J Clin Epidemiol (2011) 3.44

Consensus statement of the ESICM task force on colloid volume therapy in critically ill patients. Intensive Care Med (2012) 3.39

Association between change in high density lipoprotein cholesterol and cardiovascular disease morbidity and mortality: systematic review and meta-regression analysis. BMJ (2009) 3.39

Childhood adversities and adult psychopathology in the WHO World Mental Health Surveys. Br J Psychiatry (2010) 3.38

Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med (2014) 3.37

Barriers to full-text publication following presentation of abstracts at annual orthopaedic meetings. J Bone Joint Surg Am (2003) 3.36

Can we individualize the 'number needed to treat'? An empirical study of summary effect measures in meta-analyses. Int J Epidemiol (2002) 3.36

Primary prevention of cardiovascular mortality and events with statin treatments: a network meta-analysis involving more than 65,000 patients. J Am Coll Cardiol (2008) 3.33