Methodology of superiority vs. equivalence trials and non-inferiority trials

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

Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373 · see citing works

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

Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835 · see citing works

Assessing the quality of controlled clinical trials

Jüni, P., Altman, D. G., & Egger, M. (2001) · BMJ · doi:10.1136/bmj.323.7303.42 · Cited by 3,309 · cited 1× · see citing works

Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement

Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127 · see citing works

Clinical Trials: A Practical Approach.

Hill, I. D., & Pocock, S. (1984) · Biometrics · doi:10.2307/2531186 · Cited by 2,918 · see citing works

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

Moher, D., Schulz, K. F., & Altman, D. G. (2001) · BMC Medical Research Methodology · doi:10.1186/1471-2288-1-2 · Cited by 2,755 · see citing works

Reporting of Noninferiority and Equivalence Randomized Trials: Extension of the CONSORT 2010 Statement

Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J. W., Altman, D. G., & CONSORT Group, F. T. (2012) · JAMA · doi:10.1001/jama.2012.87802 · Cited by 2,428 · see citing works

Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles

Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845 · see citing works

Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement

Piaggio, G., Elbourne, D. R., Altman, D. G., Pocock, S. J., Evans, S. J. W., & CONSORT Group, F. T. (2006) · JAMA · doi:10.1001/jama.295.10.1152 · Cited by 1,153 · see citing works

Trials to assess equivalence: the importance of rigorous methods: Fig 1

Jones, B., Jarvis, P., Lewis, J. A., & Ebbutt, A. F. (1996) · BMJ · doi:10.1136/bmj.313.7048.36 · Cited by 1,032 · see citing works

“Proving the null hypothesis” in clinical trials

Blackwelder, W. C. (1982) · Controlled Clinical Trials · doi:10.1016/0197-2456(82)90024-1 · Cited by 890 · see citing works

Statistical Power, Sample Size, and Their Reporting in Randomized Controlled Trials

Moher, D. (1994) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1994.03520020048013 · Cited by 608 · see citing works

Quality of Reporting of Noninferiority and Equivalence Randomized Trials

Le Henanff, A., Giraudeau, B., Baron, G., & Ravaud, P. (2006) · JAMA · doi:10.1001/jama.295.10.1147 · Cited by 263 · see citing works

Statistical Methods in Medical Research.

Armitage, P., & Berry, G. (1997) · Biometrics · doi:10.2307/2533132 · Cited by 260 · see citing works

Proving the null hypothesis.

Bartko, J. J. (1991) · American Psychologist · doi:10.1037/0003-066x.46.10.1089.a · Cited by 250 · see citing works

Sample size requirements for evaluating a conservative therapy.

Makuch, R., & Simon, R. M. (1978) · PubMed · Cited by 231 · see citing works

When was a "negative" clinical trial big enough? How many patients you needed depends on what you found

Detsky, A. S. (1985) · Archives of Internal Medicine · doi:10.1001/archinte.145.4.709 · Cited by 228 · see citing works

Claims of Equivalence in Medical Research: Are They Supported by the Evidence?

Greene, W. L., Concato, J., & Feinstein, A. R. (2000) · Annals of Internal Medicine · doi:10.7326/0003-4819-132-9-200005020-00006 · Cited by 180 · see citing works

Intention-to-treat

Faller, H. (2004) · Die Rehabilitation · doi:10.1055/s-2004-818553 · Cited by 167 · see citing works

Choosing an equivalence limit for noninferiority or equivalence studies

Wiens, B. L. (2002) · Controlled Clinical Trials · doi:10.1016/s0197-2456(01)00196-9 · Cited by 164 · see citing works

Special Invited Papers Section: Therapeutic Equivalence – Clinical Issues and Statistical Methodology in Noninferiority Trials

Lange, S., & Freitag, G. (2005) · Biometrical Journal · doi:10.1002/bimj.200410085 · Cited by 111 · see citing works

Negative Results of Randomized Clinical Trials Published in the Surgical Literature

Dimick, J. B., Diener‐West, M., & Lipsett, P. A. (2001) · Archives of Surgery · doi:10.1001/archsurg.136.7.796 · Cited by 96 · see citing works

Planning and Monitoring of Equivalence Studies

Durrleman, S., & Simon, R. (1990) · Biometrics · doi:10.2307/2531438 · Cited by 96 · see citing works

Therapeutic equivalence: fallacies and falsification

Garrett, A. D. (2003) · Statistics in Medicine · doi:10.1002/sim.1360 · Cited by 88 · see citing works

Scientific and Ethical Issues in Equivalence Trials

Djulbegović, B. (2001) · JAMA · doi:10.1001/jama.285.9.1206 · Cited by 79 · see citing works

General design issues in efficacy, equivalency and superiority trials

Fleiss, J. L. (1992) · Journal of Periodontal Research · doi:10.1111/j.1600-0765.1992.tb01684.x · Cited by 49 · see citing works

Negative results in cancer clinical trials—equivalence or poor accrual?

Costa, L. J., Xavier, A. C., & del Giglio, A. (2004) · Controlled Clinical Trials · doi:10.1016/j.cct.2004.08.001 · Cited by 21 · see citing works

Untitled work

Senn (1998) · doi:10.1002/(sici)1097-0258(19980815/30)17:15/16

Machine learning for medical imaging: methodological failures and recommendations for the future

Varoquaux, G. P., & Cheplygina, V. (2022) · npj Digital Medicine · doi:10.1038/s41746-022-00592-y · Cited by 720 · see citing works

Sample size calculations: basic principles and common pitfalls

Noordzij, M., Tripepi, G. L., Dekker, F. W., Zoccali, C., Tanck, M. W. T., & Jager, K. J. (2010) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfp732 · Cited by 440 · see citing works

The effectiveness of virtual reality based interventions for symptoms of anxiety and depression: A meta-analysis

Fodor, L. A., Coteț, C. D., Cuijpers, P., Szamoskozi, Ș., David, D., & Cristea, I. A. (2018) · Scientific Reports · doi:10.1038/s41598-018-28113-6 · Cited by 284 · see citing works

The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial

Samano, N., Geijer, H., Lidén, M., Fremes, S. E., Bodin, L., & Souza, D. S. R. (2015) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2015.07.027 · Cited by 299 · see citing works

Intention to treat and per protocol analysis in clinical trials

Tripepi, G., Chesnaye, N. C., Dekker, F. W., Zoccali, C., & Jager, K. J. (2020) · Nephrology · doi:10.1111/nep.13709 · Cited by 284 · see citing works

Sample Size Calculations

Noordzij, M., Dekker, F. W., Zoccali, C., & Jager, K. J. (2011) · Nephron Clinical Practice · doi:10.1159/000322830 · Cited by 221 · see citing works

Portable Monitoring and Autotitration versus Polysomnography for the Diagnosis and Treatment of Sleep Apnea

(2008) · Sleep · doi:10.5665/sleep/31.10.1423 · Cited by 190 · see citing works

Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults

Willett, K. M., Keene, D. J., Mistry, D., Nam, J., Tutton, E., Handley, R., Morgan, L., Roberts, E., Briggs, A. H., Lall, R., et al. (2016) · JAMA · doi:10.1001/jama.2016.14719 · Cited by 135 · see citing works

Remote treatment of obsessive-compulsive disorder: A randomized controlled trial

Wootton, B. M., Dear, B. F., Johnston, L., Terides, M. D., & Titov, N. (2013) · Journal of Obsessive-Compulsive and Related Disorders · doi:10.1016/j.jocrd.2013.07.002 · Cited by 125 · see citing works

Video-assisted thoracic surgery (VATS) as a safe alternative for the resection of pulmonary metastases: a retrospective cohort study

Carballo, M., Maish, M. S., Jaroszewski, D. E., & Holmes, C. (2009) · Journal of Cardiothoracic Surgery · doi:10.1186/1749-8090-4-13 · Cited by 112 · see citing works

The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

Keene, D. J., Mistry, D., Nam, J., Tutton, E., Handley, R., Morgan, L., Roberts, E., Gray, B. M., Briggs, A. H., Lall, R., et al. (2016) · Health Technology Assessment · doi:10.3310/hta20750 · Cited by 111 · see citing works

Equivalence and Noninferiority Testing in Regression Models and Repeated-Measures Designs

Mascha, E. J., & Sessler, D. I. (2011) · Anesthesia & Analgesia · doi:10.1213/ane.0b013e318206f872 · Cited by 97 · see citing works

Transarterial chemoembolization vs bland embolization in hepatocellular carcinoma: A meta‐analysis of randomized trials

Facciorusso, A., Bellanti, F., Villani, R., Salvatore, V., Muscatiello, N., Piscaglia, F., Vendemiale, G., & Serviddio, G. (2016) · United European Gastroenterology Journal · doi:10.1177/2050640616673516 · Cited by 87 · see citing works

Azithromycin does not improve disease course in hospitalized infants with respiratory syncytial virus (RSV) lower respiratory tract disease: A randomized equivalence trial

Kneyber, M. C. J., van Woensel, J. B. M., Uijtendaal, E. V., Uiterwaal, C. S. P. M., & Kimpen, J. L. L. (2007) · Pediatric Pulmonology · doi:10.1002/ppul.20748 · Cited by 82 · see citing works

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial

Ang, M., Tan, D. T. H., & Mehta, J. S. (2012) · Trials · doi:10.1186/1745-6215-13-75 · Cited by 74 · see citing works

Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK

Perry, D. C., Achten, J., Knight, R., Appelbe, D. E., Dutton, S., Dritsaki, M., Mason, J. M., Roland, D., Messahel, S., Widnall, J., et al. (2022) · The Lancet · doi:10.1016/s0140-6736(22)01015-7 · Cited by 71 · see citing works

Non‐inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Yu, H., Lin, A. T., Yang, S. S., Tsui, K., Wu, H., Cheng, C., Cheng, H., Wu, T. T., & Chiang, P. (2011) · British Journal of Urology · doi:10.1111/j.1464-410x.2011.10233.x · Cited by 67 · see citing works

Observational Studies Are Complementary to Randomized Controlled Trials

Grootendorst, D. C., Jager, K. J., Zoccali, C., & Dekker, F. W. (2009) · Nephron Clinical Practice · doi:10.1159/000262299 · Cited by 66 · see citing works

A randomized, double-blind comparison of OROS®hydromorphone and controlled-release morphine for the control of chronic cancer pain

Hanna, M., Thipphawong, J., & the 118 study group (2008) · BMC Palliative Care · doi:10.1186/1472-684x-7-17 · Cited by 65 · see citing works

Equivalency of Fecal Immunochemical Tests and Colonoscopy in Familial Colorectal Cancer Screening

Quintero, E., Palau, M. C., Gimeno‐García, A. Z., Hernández‐Guerra, M., Nicolás–Pérez, D., Alonso-Abreu, I., Díez-Fuentes, M. L., & Abraira, V. (2014) · Gastroenterology · doi:10.1053/j.gastro.2014.08.004 · Cited by 62 · see citing works

Task shifting in maternal and newborn care: a non-inferiority study examining delegation of antenatal counseling to lay nurse aides supported by job aids in Benin

Mayo‐Wilson, L. J., Yebadokpo, A. S., Affo, J., Agbogbe, M., & Tankoano, A. (2011) · Implementation Science · doi:10.1186/1748-5908-6-2 · Cited by 57 · see citing works

Decisions about equivalence: A comparison of TOST, HDI-ROPE, and the Bayes factor.

Linde, M., Tendeiro, J. N., Selker, R., Wagenmakers, E., & van Ravenzwaaij, D. (2021) · Psychological Methods · doi:10.1037/met0000402 · Cited by 56 · see citing works

Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: A real-life observational study

Zeng, Q., Xu, G., Zhang, J., Li, W., Zhang, D., Li, Z., Liang, H., Li, C., & Yu, Z. (2017) · Journal of Hepatology · doi:10.1016/j.jhep.2017.01.025 · Cited by 52 · see citing works

Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial

Ngure, K., Ortblad, K. F., Mogere, P., Bardon, A., Thomas, K. K., Mangale, D. I., Kiptinness, C., Gakuo, S., Mbaire, S., Nyokabi, J., et al. (2022) · The Lancet HIV · doi:10.1016/s2352-3018(22)00126-6 · Cited by 47 · see citing works

Evaluating equivalence and noninferiority trials

Dasgupta, A., Lawson, K. A., & Wilson, J. P. (2010) · American Journal of Health-System Pharmacy · doi:10.2146/ajhp090507 · Cited by 45 · see citing works

Is there a role for modified probiotics as beneficial microbes: a systematic review of the literature

Zorzela, L., Ardestani, S. K., McFarland, L. V., & Vohra, S. (2017) · Beneficial Microbes · doi:10.3920/bm2017.0032 · Cited by 44 · see citing works

Clinical trial design in biosimilar drug development

Dranitsaris, G., Dorward, K., Hatzimichael, E. C., & Amir, E. (2012) · Investigational New Drugs · doi:10.1007/s10637-012-9899-2 · Cited by 46 · see citing works

The presence and characteristics of ‘spin’ among randomized controlled trial abstracts in orthodontics

Guo, F., Fang, X., Li, C., Qin, D., Hua, F., & He, H. (2021) · European Journal of Orthodontics · doi:10.1093/ejo/cjab044 · Cited by 45 · see citing works

Does 3-Day Course of Oral Amoxycillin Benefit Children of Non-Severe Pneumonia with Wheeze: A Multicentric Randomised Controlled Trial

Awasthi, S., Agarwal, G. G., Kabra, S. K., Singhi, S. C., Kulkarni, M., More, V., Niswade, A. K., Pillai, R. M., Luke, R., Srivastava, N. M., et al. (2008) · PLoS ONE · doi:10.1371/journal.pone.0001991 · Cited by 43 · see citing works

A randomised, non-inferiority trial of a new cephalonium dry-cow therapy

McDougall, S. (2010) · New Zealand Veterinary Journal · doi:10.1080/00480169.2010.65060 · Cited by 40 · see citing works

Comparisons of Superiority, Non-inferiority, and Equivalence Trials.

Wang, B., Wang, H., Tu, X. M., & Feng, C. (2017) · Europe PMC (PubMed Central) · doi:10.11919/j.issn.1002-0829.217163 · Cited by 37 · see citing works

Phase III Trials of New Oral Anticoagulants in the Acute Treatment and Secondary Prevention of VTE: Comparison and Critique of Study Methodology and Results

Cohen, A. T., Imfeld, S., & Rider, T. (2014) · Advances in Therapy · doi:10.1007/s12325-014-0119-7 · Cited by 35 · see citing works

Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial

Elheeny, A. A. H. (2020) · International Journal of Paediatric Dentistry · doi:10.1111/ipd.12640 · Cited by 35 · see citing works

The Impact of Surgery on Survival of Patients With Cutaneous Melanoma

D, S. M. M., Pasquali, S., & Nitti, D. (2010) · Annals of Surgery · doi:10.1097/sla.0b013e318207a331 · Cited by 34 · see citing works

Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part I: Study Rationale, Design and Assessment of Effectiveness

Mironov, N. Y., Vlodzyanovsky, V. V., Yuricheva, Y. A., Sokolov, S. F., Sp, G., Rosenshtraukh, L. V., & Chazov, E. I. (2018) · Rational Pharmacotherapy in Cardiology · doi:10.20996/1819-6446-2018-14-5-664-669 · Cited by 32 · see citing works

Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial

Shatkin-Margolis, A., Yook, E., Hill, A. M., Crisp, C. C., Yeung, J., Kleeman, S., & Pauls, R. N. (2019) · Obstetrics & Gynecology · doi:10.1097/aog.0000000000003531 · Cited by 32 · see citing works

NRTI Sparing Therapy in Virologically Controlled HIV-1 Infected Subjects

Maggiolo, F., Filippo, E. D., Valenti, D., Ortega, P. S., & Callegaro, A. (2016) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000000966 · Cited by 31 · see citing works

Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

Páez, A., Rovers, M. M., Hutchison, K., Rogers, W., Vasey, B., & McCulloch, P. (2021) · Annals of Surgery · doi:10.1097/sla.0000000000005053 · Cited by 31 · see citing works

Interpreting modern randomized controlled trials of medical therapy in inflammatory bowel disease

Ma, C., Jairath, V., Feagan, B. G., Peyrin‐Biroulet, L., Danese, S., Sands, B. E., & Panaccione, R. (2024) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-024-00989-y · Cited by 27 · see citing works

Virtual reality by mobile smartphone: improving child pedestrian safety

Schwebel, D. C., Severson, J., He, Y., & McClure, L. A. (2016) · Injury Prevention · doi:10.1136/injuryprev-2016-042168 · Cited by 27 · see citing works

Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial

Verlaet, A. A. J., Ceulemans, B., Verhelst, H., West, D. V., Bruyne, T. D., Pieters, L. A. C., Savelkoul, H. F. J., & Hermans, N. (2017) · Trials · doi:10.1186/s13063-017-1879-6 · Cited by 27 · see citing works

The Aspirations of Direct Aspiration for Thrombectomy in Ischemic Stroke: A Critical Analysis

Andersson, T., Wiesmann, M., Nikoubashman, O., Gopinathan, A., Bhogal, P., & Yeo, L. L. L. (2019) · Journal of Stroke · doi:10.5853/jos.2018.02026 · Cited by 27 · see citing works

An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale—A randomized controlled trial

Hansen, A. Ø., Kristensen, H. K., Cederlund, R. I., Möller, S., & Tromborg, H. B. (2020) · Journal of Hand Therapy · doi:10.1016/j.jht.2019.12.009 · Cited by 23 · see citing works

Fulvestrant for systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women: a systematic review

Flemming, J. A., Madarnas, Y., & Franek, J. A. (2008) · Breast Cancer Research and Treatment · doi:10.1007/s10549-008-0137-8 · Cited by 23 · see citing works

Sample size planning with the cost constraint for testing superiority and equivalence of two independent groups

Guo, J., Chen, H. J., & Luh, W. (2010) · British Journal of Mathematical and Statistical Psychology · doi:10.1348/000711010x512408 · Cited by 23 · see citing works

The no-touch saphenous vein graft in elderly coronary bypass patients with multiple comorbidities is a promising conduit to substitute the left internal thoracic artery

Samano, N., Geijer, H., Bodin, L., Arbeus, M., Mannion, J. D., Dashwood, M. R., & Souza, D. S. R. (2017) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2017.03.048 · Cited by 22 · see citing works

Application of clinical pathway using electronic medical record system in pediatric patients with supracondylar fracture of the humerus: a before and after comparative study

Sung, K. H., Chung, C. Y., Lee, K. M., Lee, S. Y., Ahn, S. Y., Park, S., Choi, I. H., Cho, T., Yoo, W. J., Lee, J. H., et al. (2013) · BMC Medical Informatics and Decision Making · doi:10.1186/1472-6947-13-87 · Cited by 22 · see citing works

Image quality of low mA CT pulmonary angiography reconstructed with model based iterative reconstruction versus standard CT pulmonary angiography reconstructed with filtered back projection: an equivalency trial

Montet, X., Hachulla, A.-L., Neroladaki, A., Lador, F., Rochat, T., Botsikas, D., & Becker, C. D. (2014) · European Radiology · doi:10.1007/s00330-014-3563-5 · Cited by 21 · see citing works

Group schema therapy versus group cognitive behavioral therapy for patients with social anxiety disorder and comorbid avoidant personality disorder: A randomized controlled trial

Baljé, A. E., Greeven, A., Deen, M., van Giezen, A. E., Arntz, A., & Spinhoven, P. (2024) · Journal of Anxiety Disorders · doi:10.1016/j.janxdis.2024.102860 · Cited by 20 · see citing works

The standards of reporting trials in pets (PetSORT): Explanation and elaboration

Sargeant, J. M., Ruple, A., Selmic, L. E., & O'Connor, A. M. C. (2023) · Frontiers in Veterinary Science · doi:10.3389/fvets.2023.1137781 · Cited by 25 · see citing works

Exploring different objectives in non-inferiority trials

Tweed, C., Quartagno, M., Clements, M., Turner, R., Nunn, A., Dunn, D. T., White, I. R., & Copas, A. J. (2024) · BMJ · doi:10.1136/bmj-2023-078000 · Cited by 20 · see citing works

Treatment for Childhood Apraxia of Speech: Past, Present, and Future

Maas, E. (2024) · Journal of Speech Language and Hearing Research · doi:10.1044/2024_jslhr-23-00233 · Cited by 19 · see citing works

Judge the Judges: A Large-Scale Evaluation Study of Neural Language Models for Online Review Generation

Gârbacea, C., Carton, S., Yan, S., & Mei, Q. (2019) · Conference on Empirical Methods in Natural Language Processing (EMNLP) · doi:10.18653/v1/d19-1409 · Cited by 21 · see citing works

Designing trials for pressure ulcer risk assessment research: Methodological challenges

Balzer, K., Köpke, S., Lühmann, D., Haastert, B., Kottner, J., & Meyer, G. (2013) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2013.02.008 · Cited by 18 · see citing works

Important considerations in calculating and reporting of sample size in randomized controlled trials

Valojerdi, A. E., Tanha, K., & Janani, L. (2017) · Medical Journal of the Islamic Republic of Iran · doi:10.14196/mjiri.31.127 · Cited by 17 · see citing works

Sample Size Calculation

Stock, E. M., & Biswas, K. (2017) · Springer eBooks · doi:10.1007/978-3-319-53877-8_16 · Cited by 16 · see citing works

Defining standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to mastitis pathogens

Schukken, Y. H., Rauch, B. J., & Morelli, J. (2013) · Journal of Dairy Science · doi:10.3168/jds.2012-6222 · Cited by 16 · see citing works

Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Willett, K. M., Keene, D. J., Morgan, L., Gray, B. M., Handley, R., Chesser, T. J. S., Pallister, I., Tutton, E., Knox, C., Lall, R., et al. (2014) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-15-79 · Cited by 16 · see citing works

Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol)

van IJsselmuiden, M. N., Coolen, A.-L. W. M., Detollenaere, R. J., den Boon, J., Bongers, M. Y., van de Pol, G., Vollebregt, A., Radder, C. M., Deprest, J. A., & van Eijndhoven, H. W. F. (2014) · BMC Women s Health · doi:10.1186/1472-6874-14-112 · Cited by 16 · see citing works

A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

Achten, J., Knight, R., Dutton, S., Costa, M. L., Mason, J. M., Dritsaki, M., Appelbe, D. E., Messahel, S., Roland, D., Widnall, J., et al. (2020) · Bone & Joint Open · doi:10.1302/2046-3758.16.bjo-2020-0014.r1 · Cited by 16 · see citing works

Noninferiority trial on the efficacy of premilking teat disinfectant against naturally occurring new intramammary infections using a novel 2-step diagnostic process

Ceballos-Márquez, A., Hemling, T. C., Rauch, B. J., Lopez-Benavides, M. G., & Schukken, Y. H. (2013) · Journal of Dairy Science · doi:10.3168/jds.2013-7108 · Cited by 15 · see citing works

Non-inferiority of intermittent theta burst stimulation over the left V1 vs. classical target for depression: A randomized, double-blind trial

Kong, Y., Zhou, J., Zhao, M., Zhang, Y., Tan, T., Xu, Z., Hou, Z., Yuan, Y., Tan, L., Song, R., et al. (2023) · Journal of Affective Disorders · doi:10.1016/j.jad.2023.09.024 · Cited by 14 · see citing works

Testing the Therapeutic Equivalence of Alogliptin, Linagliptin, Saxagliptin, Sitagliptin or Vildagliptin as Monotherapy or in Combination with Metformin in Patients with Type 2 Diabetes

Messori, A., Fadda, V., Maratea, D., Trippoli, S., & Marinai, C. (2014) · Diabetes Therapy · doi:10.1007/s13300-014-0066-y · Cited by 14 · see citing works

Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study

Stevens, J., Mills, S. D., Millett, M.-L. E., Lin, F., & Leeman, J. (2023) · Implementation Science · doi:10.1186/s13012-023-01317-9 · Cited by 13 · see citing works

Clinical-Grade Validation of an Autofluorescence Virtual Staining System With Human Experts and a Deep Learning System for Prostate Cancer

Wong, P. F., McNeil, C., Wang, Y., Paparian, J., Santori, C., Gutierrez, M., Homyk, A. P., Nagpal, K., Jaroensri, T., Wulczyn, E., et al. (2024) · Modern Pathology · doi:10.1016/j.modpat.2024.100573 · Cited by 13 · see citing works

Independent Housing and Support for non-homeless individuals with severe mental illness: randomised controlled trial vs. observational study – study protocol

Adamus, C., Mötteli, S., Jäger, M., & Richter, D. (2020) · BMC Psychiatry · doi:10.1186/s12888-020-02712-y · Cited by 8 · see citing works

Osteopathy and physiotherapy compared to physiotherapy alone on fatigue in long COVID: Study protocol for a pragmatic randomized controlled superiority trial

Curi, A. C. C., Ferreira, A. P. A., Nogueira, L. A. C., Meziat‐Filho, N., & Ferreira, A. D. S. (2022) · International journal of osteopathic medicine · doi:10.1016/j.ijosm.2022.04.004 · Cited by 12 · see citing works

Small Improvements in Postoperative Outcome with Gap Balancing Technique Compared with Measured Resection in Total Knee Arthroplasty

Hommel, H., Kunze, D., Hommel, P., & Fennema, P. (2017) · The Open Orthopaedics Journal · doi:10.2174/1874325001711011236 · Cited by 13 · see citing works

Target trial emulation: Do antimicrobials or gastrointestinal nutraceuticals prescribed at first presentation for acute diarrhoea cause a better clinical outcome in dogs under primary veterinary care in the UK?

Pegram, C., Diaz‐Ordaz, K., Brodbelt, D. C., Chang, Y., Tayler, S., Allerton, F., Prisk, L., Church, D. B., & O'Neill, D. G. (2023) · PLoS ONE · doi:10.1371/journal.pone.0291057 · Cited by 12 · see citing works

Nafamostat for Prophylaxis against Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis Compared with Gabexate

Chang, J. H., Lee, I. S., Kim, H. K., Cho, Y. K., Park, J. M., Kim, S. W., Choi, M., & Chung, I.-S. (2009) · Gut and Liver · doi:10.5009/gnl.2009.3.3.205 · Cited by 12 · see citing works

Head‐to‐head trials of systemic psoriasis therapies: a systematic review of study design and maximum acceptable treatment differences

Wan, M. T., Alvarez, J. L. R., Shin, D. B., Dommasch, E. D., Wu, J. J., & Gelfand, J. M. (2018) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.15174 · Cited by 12 · see citing works

Intention-to-treat analysis: Are we managing dropouts and missing data properly in research on orthodontic treatment? A systematic review

Batista, K. B. D. S. L., Thiruvenkatachari, B., & O'Brien, K. D. (2018) · American Journal of Orthodontics and Dentofacial Orthopedics · doi:10.1016/j.ajodo.2018.08.013 · Cited by 12 · see citing works

Systematic evaluation of non-inferiority and equivalence randomized trials of anti-infective drugs

Li, Y., He, Y., Sheng, Y., Wang, K., Wang, J., Huang, J., Yang, J., & Zheng, Q. (2013) · Expert Review of Anti-infective Therapy · doi:10.1586/14787210.2013.851600 · Cited by 10 · see citing works

Diagnostic utility of core needle biopsy versus open wedge biopsy for pediatric intraabdominal solid tumors: Results of a prospective clinical study

Deeney, S., Stewart, C. L., Treece, A. L., Black, J. O., Lovell, M. A., Garrington, T. P., Karrer, F. M., & Bruny, J. L. (2017) · Journal of Pediatric Surgery · doi:10.1016/j.jpedsurg.2017.08.032 · Cited by 11 · see citing works

Randomized Single-Blinded Non-inferiority Trial Of 7 mg/kg Pentamidine Isethionate Versus 4 mg/kg Pentamidine Isethionate for Cutaneous Leishmaniaisis in Suriname

Hu, R. V. P. F., Straetemans, M., Kent, A. D., Sabajo, L. O. A., de Vries, H. J. C., & Fat, R. F. M. L. A. (2015) · PLoS neglected tropical diseases · doi:10.1371/journal.pntd.0003592 · Cited by 10 · see citing works

Clinical vs. statistical significance: considerations for clinical laboratories

Hakan, H., Tran, M. T. C., Markus, C., Ho, C. S., Loh, T. P., Zakaria, R., Cooke, B. R., Theodorsson, E., & Greaves, R. F. (2025) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2025-0219 · Cited by 10 · see citing works

Long-Arm Splinting Versus Above-Elbow Casting for Type 1 Supracondylar Fractures of the Humerus in Children: a Randomized Controlled Trial

Siu, C., Farrell, S., Schaeffer, E. K., Doan, Q. H., Dobbe, A., Bone, J. N., Reilly, C. W., & Mulpuri, K. (2023) · SN Comprehensive Clinical Medicine · doi:10.1007/s42399-023-01417-z · Cited by 9 · see citing works

Comparison of diagnostic accuracy and interpretation times for a standard and an advanced 3D visualisation technique in CT colonography

Mang, T. G., Kolligs, F. T., Schaefer, C., Reiser, M., & Graser, A. (2010) · European Radiology · doi:10.1007/s00330-010-1953-x · Cited by 9 · see citing works

Factors, issues and interdependencies in the incorporation of a Web 2.0 based learning environment in higher education

Karvounidis, T., Chimos, K., Bersimis, S., & Douligeris, C. (2017) · Education and Information Technologies · doi:10.1007/s10639-017-9644-8 · Cited by 9 · see citing works

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial

Atuhairwe, S., Byamugisha, J. K., Klingberg‐Allvin, M., Cleeve, A., Hanson, C., Tumwesigye, N. M., Kakaire, O., & Gemzell‐Danielsson, K. (2019) · Trials · doi:10.1186/s13063-019-3490-5 · Cited by 10 · see citing works

A randomized double-blind, non-inferiority Phase II trial, comparing dapaconazole tosylate 2% cream with ketoconazole 2% cream in the treatment ofPityriasis versicolor

Gobbato, A. A. M., Babadópulos, T., Gobbato, C. A. R. S., Ilha, J. O., Gagliano‐Jucá, T., & Nucci, G. D. (2015) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.2015.1083009 · Cited by 9 · see citing works

In patients with HCV genotype 2 or 3 infection and RVR 14 weeks treatment is noninferior to 24 weeks. Pooled analysis of two Scandinavian trials

Dalgård, O., Bjøro, K., Ring‐Larsen, H., & Verbaan, H. (2010) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0b013e328335b29e · Cited by 9 · see citing works

Abstracts of randomized controlled trials in pediatric dentistry: reporting quality and spin

Guo, F., Ye, W., Qin, D., Fang, X., Hua, F., & He, H. (2023) · BMC Medical Research Methodology · doi:10.1186/s12874-023-02085-2 · Cited by 9 · see citing works

Impact of eHealth education to reduce anemia among school-going adolescent girls in rural Bangladesh: Study protocol of a randomized controlled trial

Rahman, M. J., Rahman, M. M., Kakehashi, M., Matsuyama, R., Sarker, M. H. R., Ali, M., Promitee, S. K., Prihanto, J. B., Ahmed, A., & Shimpuku, Y. (2023) · Journal of Family Medicine and Primary Care · doi:10.4103/jfmpc.jfmpc_1010_23 · Cited by 8 · see citing works

Low‐ and standard‐dose peginterferon alfa‐2a for chronic hepatitis C, genotype 2 or 3: efficacy, tolerability, viral kinetics and cytokine response

Rotman, Y., Borg, B. B., Soza, A., Feld, J. J., Modi, A. A., Loomba, R. S., Lutchman, G. A., Rivera, E., Doo, E. C., Ghany, M. G., et al. (2010) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2010.04263.x · Cited by 8 · see citing works

Testing the therapeutic equivalence of novel oral anticoagulants for thromboprophylaxis in orthopedic surgery and for prevention of stroke in atrial fibrillation

Messori, A., Fadda, V., Maratea, D., Trippoli, S., & Marinai, C. (2014) · International Journal of Clinical Pharmacology and Therapeutics · doi:10.5414/cp202183 · Cited by 8 · see citing works

A hybrid type I trial to increase Veterans’ access to insomnia care: study protocol for a randomized controlled trial

Bramoweth, A. D., Germain, A., Youk, A. O., Rodriguez, K. L., & Chinman, M. (2018) · Trials · doi:10.1186/s13063-017-2437-y · Cited by 8 · see citing works

Liver transplantation at safety net hospitals: Potentially vulnerable patients with noninferior outcomes

Lee, T. C., Dhar, V. K., Hoehn, R. S., Wima, K., Kim, Y., Ertel, A. E., Patel, S. H., & Shah, S. A. (2019) · Surgery · doi:10.1016/j.surg.2019.06.020 · Cited by 8 · see citing works

Adequacy of Nutrient Intakes of Severely and Acutely Malnourished Children Treated with Different Doses of Ready-To-Use Therapeutic Food in Burkina Faso

Nikièma, V., Kangas, S. T., Salpéteur, C., Ouédraogo, A., Lachat, C. K., Bassolé, I. H. N., & Fanou‐Fogny, N. (2020) · Journal of Nutrition · doi:10.1093/jn/nxaa393 · Cited by 8 · see citing works

Effectiveness and acceptance of technology-based psychological interventions for the acute treatment of unipolar depression: a systematic review and meta-analysis (Preprint)

Köhnen, M., Kriston, L., Härter, M. C., Baumeister, H., & Liebherz, S. (2020) · Journal of Medical Internet Research · doi:10.2196/24584 · Cited by 10 · see citing works

The Forearm Fracture Recovery in Children Evaluation (FORCE) trial: statistical and health economic analysis plan for an equivalence randomized controlled trial of treatment for torus fractures of the distal radius in children

Knight, R., Dritsaki, M., Mason, J. M., Perry, D. C., & Dutton, S. (2020) · Bone & Joint Open · doi:10.1302/2046-3758.16.bjo-2020-0015.r1 · Cited by 8 · see citing works

Offer of a bandage versus rigid immobilisation in 4- to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT

Perry, D. C., Achten, J., Knight, R., Dutton, S., Dritsaki, M., Mason, J. M., Appelbe, D. E., Roland, D., Messahel, S., Widnall, J., et al. (2022) · Health Technology Assessment · doi:10.3310/bdns6122 · Cited by 9 · see citing works

Cytotoxic Effects of Common Irrigation Solutions on Chondrosarcoma and Giant Cell Tumors of Bone

Moore, C., Fernandes, R. J., Manrique, J., Polissar, N. L., Miljacic, L., Hippe, D. S., Vaux, J., & Thompson, M. J. (2022) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.22.00404 · Cited by 8 · see citing works

A randomized trial of the effect of escitalopram versus placebo on cognitive function in healthy first-degree relatives of patients with depression

Knorr, U. B., Vinberg, M., Gade, A., Winkel, P., Gluud, C. N., Wetterslev, J., Gether, U., & Kessing, L. V. (2011) · Therapeutic Advances in Psychopharmacology · doi:10.1177/2045125311422591 · Cited by 8 · see citing works

An introduction to sample size calculations in clinical trials

Accordini, S. (2007) · Epidemiology and Psychiatric Sciences · doi:10.1017/s1121189x00002475 · Cited by 8 · see citing works

Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial

Crawcour, S. C., Leibing, E., Ginzburg, D. M., Stangier, U., Wiltink, J., & Hoyer, J. (2012) · Trials · doi:10.1186/1745-6215-13-70 · Cited by 7 · see citing works

Developing a Hypothesis and Statistical Planning

Nizamuddin, S. L., Nizamuddin, J., Mueller, A., Ramakrishna, H., & Shahul, S. S. (2017) · Journal of Cardiothoracic and Vascular Anesthesia · doi:10.1053/j.jvca.2017.04.020 · Cited by 7 · see citing works

Impact of mobile health-based nutritional education on hemoglobin levels in anemic adolescent girls in rural Bangladesh: a randomized controlled trial

Rahman, M. J., Rahman, M. M., Sarker, M. H. R., Matsuyama, R., Kakehashi, M., Tsunematsu, M., Ali, M., Ahmed, A., Hawlader, M. D. H., Kawasaki, H., et al. (2025) · BMC Public Health · doi:10.1186/s12889-025-23687-z · Cited by 6 · see citing works

Prospective randomized multicenter noninferiority clinical trial evaluating the use of TFN-advancedTM proximal femoral nailing system (TFNA) for the treatment of proximal femur fracture in a Chinese population

Zhang, L., Pan, Z., Zheng, X., Wang, Q., Tang, P., Zhou, F., Liu, F., Yu, B., Leung, F. K. L., Wu, A., et al. (2023) · European Journal of Trauma and Emergency Surgery · doi:10.1007/s00068-023-02231-x · Cited by 6 · see citing works

Sample Size Calculation in Economic Experiments

Grüner, S. (2020) · Jahrbücher für Nationalökonomie und Statistik · doi:10.1515/jbnst-2019-0020 · Cited by 6 · see citing works

Metoder ved aekvivalens- og noninferioritetsundersogelser

Christensen, E. (2008) · Research at the University of Copenhagen (University of Copenhagen)

Methodological aspects of superiority, equivalence, and non-inferiority trials

Roumeliotis, S. K., D’Arrigo, G., & Tripepi, G. L. (2020) · Internal and Emergency Medicine · doi:10.1007/s11739-020-02450-9 · Cited by 39 · see citing works

Principles of Superiority, Equivalence and Non-inferiority trials

Pensawangwat, P. (2020) · Isan Journal of Pharmaceutical Sciences, IJPS (Isan J Pharm Sci) · doi:10.14456/ijps.2020.2

Equivalence and noninferiority trials: Design, measures, and classic example

Woite, N. L., Silva, A. C. W., & Lima, B. B. (2025) · Elsevier eBooks · doi:10.1016/b978-0-323-91790-2.00017-4

Superiority, equivalence, and non-inferiority trials.

Lesaffre, E. M. E. H. (2008) · PubMed · Cited by 225 · see citing works