Multiplicity in randomised trials I: endpoints and treatments

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The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials

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The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration

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Clinical Trials: A Practical Approach.

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Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design

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Fundamentals of Clinical Trials

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Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes

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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

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When to use the Bonferroni correction

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Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial

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False discovery rate control is a recommended alternative to Bonferroni-type adjustments in health studies

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Liberal or Restrictive Transfusion after Cardiac Surgery

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Vitamin D supplementation and prevention of type 2 diabetes

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Follow-up of blood-pressure lowering and glucose control in type 2 diabetes

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Correction for Multiple Testing

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Combination Antifungal Therapy for Cryptococcal Meningitis

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Effect of Online Hemodiafiltration on All-Cause Mortality and Cardiovascular Outcomes

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The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

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Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial

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Five-Year Follow-up of a Randomized Multicenter Trial of Intensive Early Intervention vs Standard Treatment for Patients With a First Episode of Psychotic Illness

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Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome

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High-Dose Rifapentine with Moxifloxacin for Pulmonary Tuberculosis

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Effects of vitamin D and calcium supplementation on pancreatic β cell function, insulin sensitivity, and glycemia in adults at high risk of diabetes: the Calcium and Vitamin D for Diabetes Mellitus (CaDDM) randomized controlled trial

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An introduction to multiplicity issues in clinical trials: the what, why, when and how

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Effect of a community-led sanitation intervention on child diarrhoea and child growth in rural Mali: a cluster-randomised controlled trial

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When to adjust alpha during multiple testing: a consideration of disjunction, conjunction, and individual testing

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Multiplicity in randomised trials II: subgroup and interim analyses

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Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial

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World Health Organization randomized trial of calcium supplementation among low calcium intake pregnant women

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Best (but oft-forgotten) practices: the multiple problems of multiplicity—whether and how to correct for many statistical tests

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Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial

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Correcting vitamin D insufficiency improves insulin sensitivity in obese adolescents: a randomized controlled trial

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Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement

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Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial

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A Double-Blind Randomized Controlled Trial of N -Acetylcysteine in Cannabis-Dependent Adolescents

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Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial

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Short-and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial

Turner, J. A., Mancl, L., & Aaron, L. A. (2006) · Pain · doi:10.1016/j.pain.2005.11.017 · Cited by 270

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial

Ferrando, C., Soro, M., Unzueta, C., Suárez-Sipmann, F., Canet, J., Librero, J., Pozo, N., Peiró, S., Llombart, A., León, I., et al. (2018) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(18)30024-9 · Cited by 258

Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale

Arnold, B. F., Null, C., Luby, S. P., UNICOMB, L. E., Stewart, C. P., Dewey, K. G., Ahmed, T., Ashraf, S., Christensen, G., Clasen, T., et al. (2013) · BMJ Open · doi:10.1136/bmjopen-2013-003476 · Cited by 253

Evidence at a glance: error matrix approach for overviewing available evidence

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Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials

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Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial

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Do p Values Lose Their Meaning in Exploratory Analyses? It Depends How You Define the Familywise Error Rate

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Relationship between resilience and stress: Perceived stress, stressful life events, HPA axis response during a stressful task and hair cortisol

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Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial

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Effect of Repetitive Intra-Arterial Infusion of Bone Marrow Mononuclear Cells in Patients With No-Option Limb Ischemia

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Short-term time-restricted feeding is safe and feasible in non-obese healthy midlife and older adults

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A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk

Patel, A. A., Cass, A., Peiris, D., Usherwood, T. P., Brown, A. D. H., Jan, S., Neal, B. C., Hillis, G. S., Rafter, N., Tonkin, A., et al. (2014) · European Journal of Preventive Cardiology · doi:10.1177/2047487314530382 · Cited by 184

Effect of Bronchoalveolar Lavage–Directed Therapy on Pseudomonas aeruginosa Infection and Structural Lung Injury in Children With Cystic Fibrosis

Wainwright, C. E., Vidmar, S., Armstrong, D., Byrnes, C. A., Carlin, J. B., Cheney, J. L., Cooper, P., Grimwood, K., Moodie, M., ROBERTSON, C. F., et al. (2011) · JAMA · doi:10.1001/jama.2011.954 · Cited by 180

Maternal Plasma Polyunsaturated Fatty Acid Status in Late Pregnancy Is Associated with Offspring Body Composition in Childhood

Moon, R. J., Harvey, N. C., Robinson, S. M., Ntani, G., Davies, J. H., Inskip, H. M., Godfrey, K. M., Dennison, E. M., Calder, P. C., Cooper, C. C., et al. (2012) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2012-2482 · Cited by 176

Oral folic acid and vitamin B-12 supplementation to prevent cognitive decline in community-dwelling older adults with depressive symptoms--the Beyond Ageing Project: A randomized controlled trial

Walker, J. G., Batterham, P. J., Mackinnon, A. J., Jorm, A. F., Hickie, I., Fenech, M., Kljakovic, M., Crisp, D., & Christensen, H. (2012) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.110.007799 · Cited by 165

Subtle cognitive impairments in patients with long-term cure of Cushing’s disease

Tiemensma, J., Kokshoorn, N. E., Biermasz, N. R., Keijser, B.-J. S. A., Wassenaar, M. J. E., Middelkoop, H. A. M., Pereira, A. M., & Romijn, J. A. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-2032 · Cited by 159

Coup de Grâce for a Tough Old Bull: “Statistically Significant” Expires

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The Definition and Measurement of Disease Modification in Inflammatory Rheumatic Diseases

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Mitigating the effect of persistent postnatal depression on child outcomes through an intervention to treat depression and improve parenting: a randomised controlled trial

Stein, A., Netsi, E., Lawrence, P. J., Granger, C., Kempton, C., Craske, M. G., Nickless, A., Mollison, J., Stewart, D. A., Rapa, E., et al. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30006-3 · Cited by 148

Effect of a Computer-Guided, Quality Improvement Program for Cardiovascular Disease Risk Management in Primary Health Care

Peiris, D., Usherwood, T. P., Panaretto, K. S., Harris, M., Hunt, J., Redfern, J., Zwar, N. A., Colagiuri, S., Hayman, N. E., Lo, S., et al. (2015) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.114.001235 · Cited by 143

A Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas for Type 1 Diabetes: A Randomized Controlled Crossover Trial

Haidar, A., Tsoukas, M. A., Bernier-Twardy, S., Yale, J., Rutkowski, J., Bossy, A., Pytka, E., Fathi, A. E., Strauss, N., & Legault, L. (2020) · Diabetes Care · doi:10.2337/dc19-1922 · Cited by 149

Prospects for epigenetic research within cohort studies of psychological disorder: A pilot investigation of a peripheral cell marker of epigenetic risk for depression

Olsson, C. A., Foley, D. L., Parkinson-Bates, M., Byrnes, G., McKenzie, M., Patton, G. C., Morley, R., Anney, R. J. L., Craig, J. M., & Saffery, R. (2010) · Biological Psychology · doi:10.1016/j.biopsycho.2009.12.003 · Cited by 137

Aortic Valve Calcification and Mild Tricuspid Regurgitation But No Clinical Heart Disease after 8 Years of Dopamine Agonist Therapy for Prolactinoma

Kars, M., Delgado, V., Holman, E. R., Feelders, R. A., Smit, J. W. A., Romijn, J. A., Bax, J. J., & Pereira, A. M. (2008) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2007-2658 · Cited by 135

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

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Key Issues in End Point Selection for Heart Failure Trials: Composite End Points

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Management of Medication Overuse Headache: 1-Year Randomized Multicentre Open-Label Trial

Hagen, K., Albretsen, C., Vilming, S. T., Salvesen, R., Grøning, M., Helde, G., Gravdahl, G. B., Zwart, J.-A., & Stovner, L. (2008) · Cephalalgia · doi:10.1111/j.1468-2982.2008.01711.x · Cited by 126

Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis

Seidler, A. L., Aberoumand, M., Hunter, K. E., Barba, A., Libesman, S., Williams, J. G., Shrestha, N., Aagerup, J., Sotiropoulos, J. X., Montgomery, A. A., et al. (2023) · The Lancet · doi:10.1016/s0140-6736(23)02468-6 · Cited by 125

Education plus exercise versus corticosteroid injection use versus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomised clinical trial

Mellor, R., Bennell, K. L., Grimaldi, A. M., Nicolson, P. J. A., Kasza, J., Hodges, P. W., Wajswelner, H., & Vicenzino, B. (2018) · BMJ · doi:10.1136/bmj.k1662 · Cited by 124

Efficacy of psychosocial interventions in cancer care: Evidence is weaker than it first looks

Coyne, J. C., Lepore, S. J., & Palmer, S. C. (2006) · Annals of Behavioral Medicine · doi:10.1207/s15324796abm3202_5 · Cited by 123

Visual evoked potential latency, amplitude and habituation in migraine: A longitudinal study

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Interictal quantitative EEG in migraine: a blinded controlled study

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Phosphatidylcholine supplementation in pregnant women consuming moderate-choline diets does not enhance infant cognitive function: a randomized, double-blind, placebo-controlled trial

Cheatham, C. L., Goldman, B. D., Fischer, L. M., da Costa, K.-A., Reznick, J. S., & Zeisel, S. H. (2012) · American Journal of Clinical Nutrition · doi:10.3945/ajcn.112.037184 · Cited by 105

Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer

for the Regensburg QoL Study Group, Klinkhammer‐Schalke, M., Koller, M. T., Steinger, B., Ehret, C., Ernst, B., Wyatt, J. C., Hofstädter, F., & Lorenz, W. (2012) · British Journal of Cancer · doi:10.1038/bjc.2012.4 · Cited by 103

Does tailoring make a difference? A systematic review of the long-term effectiveness of tailored nutrition education for adults

Eyles, H. C., & Mhurchú, C. N. (2009) · Nutrition Reviews · doi:10.1111/j.1753-4887.2009.00219.x · Cited by 102

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care

Murray, E., Sweeting, M. J., Dack, C., Pal, K., Modrow, K., Hudda, M. T., Li, J., Ross, J., Alkhaldi, G., Barnard, M., et al. (2017) · BMJ Open · doi:10.1136/bmjopen-2017-016009 · Cited by 98

A randomized placebo-controlled trial of an omega-3 fatty acid and vitamins E+C in schizophrenia

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Multifactorial intervention with nurse practitioners does not change cardiovascular outcomes in patients with chronic kidney disease

van Zuilen, A. D., Bots, M. L., Dülger, A., van der Tweel, I., van Buren, M., ten Dam, M. A. G. J., Kaasjager, K. A. H., Ligtenberg, G., Sijpkens, Y. W. J., Sluiter, H. E., et al. (2012) · Kidney International · doi:10.1038/ki.2012.137 · Cited by 96

Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial

Pickering, A. J., Crider, Y., Sultana, S., Swarthout, J., Goddard, F. G., Anjerul Islam, S., Sen, S., Ayyagari, R., & Luby, S. P. (2019) · The Lancet Global Health · doi:10.1016/s2214-109x(19)30315-8 · Cited by 95

Effects of single and integrated water, sanitation, handwashing, and nutrition interventions on child soil-transmitted helminth and Giardia infections: A cluster-randomized controlled trial in rural Kenya

Pickering, A. J., Njenga, S. M., Steinbaum, L., Swarthout, J., Lin, A., Arnold, B. F., Stewart, C. P., Dentz, H. N., Mureithi, M., Chieng, B., et al. (2019) · PLOS Medicine · doi:10.1371/journal.pmed.1002841 · Cited by 95

Flavanones protect from arterial stiffness in postmenopausal women consuming grapefruit juice for 6 mo: a randomized, controlled, crossover trial

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