Intention to treat and per protocol analysis in clinical trials

Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial

Writing Group for the Women's Health Initiative Investigators (2002) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.288.3.321 · Cited by 15,889 · see citing works

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes

Zinman, B., Wanner, C., Lachin, J. M., Fitchett, D., Bluhmki, E., Hantel, S., Mattheus, M., Devins, T., Johansen, O. E., Woerle, H. J., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504720 · Cited by 12,315 · cited 1× · see citing works

CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials

Schulz, K. F., Altman, D. G., Moher, D., & for the CONSORT Group (2010) · PLoS Medicine · doi:10.1371/journal.pmed.1000251 · Cited by 2,296 · see citing works

The Hazards of Hazard Ratios

Hernán, M. Á. (2009) · Epidemiology · doi:10.1097/ede.0b013e3181c1ea43 · Cited by 1,367 · see citing works

Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial

Manfredini, F., Mallamaci, F., D’Arrigo, G., Baggetta, R., Bolignano, D., Torino, C., Lamberti, N., Bertoli, S. V., Ciurlino, D., Rocca-Rey, L. A., et al. (2016) · Journal of the American Society of Nephrology · doi:10.1681/asn.2016030378 · Cited by 423 · see citing works

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

Christensen, E. (2007) · Journal of Hepatology · doi:10.1016/j.jhep.2007.02.015 · Cited by 205 · see citing works

Non-inferiority study design: lessons to be learned from cardiovascular trials

Head, S. J., Kaul, S., Bogers, A. J. J. C., & Kappetein, A. P. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs099 · Cited by 169 · see citing works

Carfilzomib–lenalidomide–dexamethasone vs lenalidomide–dexamethasone in relapsed multiple myeloma by previous treatment

Dimopoulos, M. A., Stewart, A. K., Masszi, T., Špıčka, I., Oriol, A., Hájek, R., Rosiñol, L., Siegel, D. S. D., Mihaylov, G. G., Goranova‐Marinova, V., et al. (2017) · Blood Cancer Journal · doi:10.1038/bcj.2017.31 · Cited by 66 · see citing works

Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study

Dimopoulos, M. A., Wang, M. L., Maisnar, V., Minařík, J., Bensinger, W., Mateos, M., Obreja, M., Blædel, J., & Moreau, P. (2018) · Journal of Hematology & Oncology · doi:10.1186/s13045-018-0583-7 · Cited by 46 · see citing works

The randomized clinical trial: An unbeatable standard in clinical research?

Stel, V. S., Jager, K. J., Zoccali, C., Wanner, C., & Dekker, F. W. (2007) · Kidney International · doi:10.1038/sj.ki.5002354 · Cited by 44 · see citing works

Effectiveness of mindfulness-based interventions on anxiety, depression, and fatigue in people with lung cancer: A systematic review and meta-analysis

Li, J., Li, C., Puts, M., Wu, Y.-C., Lyu, M.-M., Yuan, B., & Zhang, J.-P. (2023) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2023.104447 · Cited by 127 · see citing works

Intention to treat and per protocol analyses: differences and similarities

Calafell, J. M., Burón, A., Castells, X., & Porta, M. S. (2024) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2024.111457 · Cited by 90 · see citing works

Association of Tirofiban With Functional Outcomes After Thrombectomy in Acute Ischemic Stroke Due to Intracranial Atherosclerotic Disease

Sang, H., Xie, D., Tian, Y., Nguyen, T. N., Saver, J. L., Nogueira, R. G., Wu, J., Chen, L., Tian, Z., Hu, Z., et al. (2023) · Neurology · doi:10.1212/wnl.0000000000207194 · Cited by 74 · see citing works

Intention-to-treat versus as-treated versus per-protocol approaches to analysis

Ahn, E. J., & Kang, H. (2023) · Korean Journal of Anesthesiology · doi:10.4097/kja.23278 · Cited by 78 · see citing works

Efficacy of an mHealth App to Support Patients’ Self-Management of Hypertension: Randomized Controlled Trial

Liu, F., Song, T., Yu, P., Deng, N., Guan, Y., Yang, Y., & Ma, Y. (2023) · Journal of Medical Internet Research · doi:10.2196/43809 · Cited by 72 · see citing works

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

van der Vaart, L. R., Vollebregt, A., Milani, A. L., Lagro-Janssen, A. L. M., Duijnhoven, R. G., Roovers, J., & van der Vaart, C. H. (2022) · JAMA · doi:10.1001/jama.2022.22385 · Cited by 49 · see citing works

A Randomized Controlled Trial of an Online Self-Help Mindfulness Intervention for Emotional Distress: Serial Mediating Effects of Mindfulness and Experiential Avoidance

Li, Y., Zhang, A. J., Meng, Y., Hofmann, S. G., Zhou, A. Y., & Liu, X. (2023) · Mindfulness · doi:10.1007/s12671-023-02083-x · Cited by 36 · see citing works

Comparative Cardiovascular Benefits of Bempedoic Acid and Statin Drugs

Lincoff, A. M., Ray, K. K., Sasiela, W. J., Haddad, T. M., Nicholls, S. J., Li, N., Cho, L., Mason, D., Libby, P., Goodman, S. G., et al. (2024) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2024.04.048 · Cited by 44 · see citing works

School mental health prevention and intervention strategies in China: a scoping review

Qu, D., Wen, X., Cheng, X., Zhu, A., Wu, Z., Che, L., & Chen, R. (2024) · The Lancet Regional Health - Western Pacific · doi:10.1016/j.lanwpc.2024.101243 · Cited by 42 · see citing works

A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial

Knefel, M., Kantor, V., Weindl, D., Schieß-Jokanovic, J., Nicholson, A. A., Verginer, L., Schäfer, I., & Lueger‐Schuster, B. (2022) · European Journal of Psychotraumatology · doi:10.1080/20008198.2022.2068911 · Cited by 35 · see citing works

The effect of exogenous estrogen on depressive mood in women: A systematic review and meta-analysis of randomized controlled trials

Zhang, J., Yin, J., Song, X., Lai, S., Zhong, S., & Jia, Y. (2023) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2023.04.002 · Cited by 35 · see citing works

Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients

Mallamaci, F., D’Arrigo, G., Tripepi, G. L., Lamberti, N., Torino, C., Manfredini, F., & Zoccali, C. (2022) · Clinical Journal of the American Society of Nephrology · doi:10.2215/cjn.03160322 · Cited by 34 · see citing works

Metaverse-based social skills training programme for children with autism spectrum disorder to improve social interaction ability: an open-label, single-centre, randomised controlled pilot trial

Lee, J., Lee, T. S., Yoo, S., Lee, S., Jang, J. H., Choi, Y., & Park, Y. (2023) · EClinicalMedicine · doi:10.1016/j.eclinm.2023.102072 · Cited by 36 · see citing works

Effects of Different Types of Intermittent Fasting Interventions on Metabolic Health in Healthy Individuals (EDIF): A Randomised Trial with a Controlled-Run in Phase

Herz, D., Karl, S., Weiß, J. W., Zimmermann, P., Haupt, S., Zimmer, R. T., Schierbauer, J., Wachsmuth, N. B., Erlmann, M. P., Niedrist, T., et al. (2024) · Nutrients · doi:10.3390/nu16081114 · Cited by 29 · see citing works

The influence of mobile applications and social media-based interventions in producing behavior change among orthodontic patients: A systematic review and meta-analysis

Al-Moghrabi, D., Alkadhimi, A. F., Tsichlaki, A., Pandis, N., & Fleming, P. S. (2021) · American Journal of Orthodontics and Dentofacial Orthopedics · doi:10.1016/j.ajodo.2021.09.009 · Cited by 30 · see citing works

Food-Focused Media Literacy for Remotely Acculturating Adolescents and Mothers: A Randomized Controlled Trial of the “JUS Media? Programme”

Ferguson, G. M., Gardner, J. M., Nelson, M. R., Giray, C., Sundaram, H., Fiese, B. H., Koester, B. D., Tran, S. P., & Powell, R. (2021) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2021.06.006 · Cited by 30 · see citing works

Effect of antipsychotics and mood stabilisers on metabolism in bipolar disorder: a network meta-analysis of randomised-controlled trials

Kong, L., Wang, H., Yan, N., Xu, C., Chen, Y., Zeng, Y., Guo, X., Lü, J., & Hu, S. (2024) · EClinicalMedicine · doi:10.1016/j.eclinm.2024.102581 · Cited by 29 · see citing works

Wearable transcutaneous electrical nerve stimulation (actiTENS®) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids

Maheu, E., Soriot-Thomas, S., Noel, E., Ganry, H., Lespessailles, É., & Cortet, B. (2022) · Therapeutic Advances in Musculoskeletal Disease · doi:10.1177/1759720x211066233 · Cited by 28 · see citing works

Mebendazole; from an anti-parasitic drug to a promising candidate for drug repurposing in colorectal cancer

Hegazy, S. K., El-Azab, G. A., Zakaria, F., Mostafa, M. F., & El-Ghoneimy, R. A. (2022) · Life Sciences · doi:10.1016/j.lfs.2022.120536 · Cited by 29 · see citing works

Regression discontinuity design studies: a guide for health researchers

Calónico, S., Jawadekar, N., Kezios, K., & Hazzouri, A. Z. A. (2024) · BMJ · doi:10.1136/bmj-2022-072254 · Cited by 26 · see citing works

Effects of the “AI-TA” Mobile App With Intelligent Design on Psychological and Related Symptoms of Young Survivors of Breast Cancer: Randomized Controlled Trial

Jiang, L., Xu, J., Wu, Y., Liu, Y., Wang, X., & Hu, Y. (2024) · JMIR mHealth and uHealth · doi:10.2196/50783 · Cited by 27 · see citing works

Investigation of the stress-buffering effect of physical exercise and fitness on mental and physical health outcomes in insufficiently active men: A randomized controlled trial

Klaperski, S., & Fuchs, R. (2021) · Mental health and physical activity · doi:10.1016/j.mhpa.2021.100408 · Cited by 25 · see citing works

The Emergency Medical Services Sleep Health Study: A cluster-randomized trial

Patterson, P. D., Martin, S. E., Brassil, B., Hsiao, W.-H., Weaver, M. D., Okerman, T. S., Seitz, S. N., Patterson, C. G., & Robinson, K. S. (2022) · Sleep Health · doi:10.1016/j.sleh.2022.09.013 · Cited by 24 · see citing works

Effect of intra-arrest trans-nasal evaporative cooling in out-of-hospital cardiac arrest: a pooled individual participant data analysis

Taccone, F. S., Hollenberg, J., Forsberg, S., Truhlář, A., Jonsson, M. N., Annoni, F., Gryth, D., Ringh, M., Cuny, J., Busch, H.-J., et al. (2021) · Critical Care · doi:10.1186/s13054-021-03583-9 · Cited by 23 · see citing works

Transcutaneous electrical cranial‐auricular acupoint stimulation versus escitalopram for mild‐to‐moderate depression: An assessor‐blinded, randomized, non‐inferiority trial

Zhang, Z., Zhang, S., Yang, X., Qin, Z., Xu, F., Jin, G., Hou, X., Liu, Y., Cai, J., Xiao, H., et al. (2022) · Psychiatry and Clinical Neurosciences · doi:10.1111/pcn.13512 · Cited by 23 · see citing works

The influence of hatha yoga on stress, anxiety, and suppression: A randomized controlled trial

Szaszkó, B., Schmid, R. R., Pomper, U., Maiworm, M., Laiber, S., Tschenett, H., Nater, U. M., & Ulrich Ansorge, A. (2023) · Acta Psychologica · doi:10.1016/j.actpsy.2023.104075 · Cited by 28 · see citing works

Distress tolerance as a mediator of mindfulness-based intervention for anxiety and depression: Evidence from two randomized controlled trials

Li, Y., He, M., Wang, Z., Hofmann, S. G., & Liu, X. (2024) · International Journal of Clinical and Health Psychology · doi:10.1016/j.ijchp.2024.100445 · Cited by 22 · see citing works

Bilateral lysis of aortic saddle thrombus with early tissue plasminogen activator (BLASTT): a prospective, randomized, placebo-controlled study in feline acute aortic thromboembolism

Guillaumin, J., DeFrancesco, T. C., Scansen, B. A., Quinn, R. L., Whelan, M. F., Hanel, R. M., Goy‐Thollot, I., Bublot, I., Robertson, J. B., & Bonagura, J. D. (2022) · Journal of Feline Medicine and Surgery · doi:10.1177/1098612x221135105 · Cited by 22 · see citing works

Efficacy of combined hand exercise intervention in patients with chemotherapy-induced peripheral neuropathy: a pilot randomized controlled trial

Ikio, Y., Sagari, A., Nakashima, A., Matsuda, D., Sawai, T., & Higashi, T. (2022) · Supportive Care in Cancer · doi:10.1007/s00520-022-06846-5 · Cited by 21 · see citing works

Effectiveness of a theory-underpinning exercise intervention among community-dwelling (pre)frail older adults: A stepped-wedge cluster-randomized trial

Qiao, X., Ji, L., Jin, Y., Si, H., Bian, Y., Wang, W., Liu, Q., Yu, J., Zhou, W., & Wang, C. (2024) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2024.104933 · Cited by 20 · see citing works

Improving Upper Extremity Bradykinesia in Parkinson’s Disease: A Randomized Clinical Trial on the Use of Gravity-Supporting Exoskeletons

Raciti, L., Pignolo, L., Perini, V., Pullia, M., Porcari, B., Latella, D., Isgrò, M., Naro, A., & Calabrò, R. S. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11092543 · Cited by 20 · see citing works

A comparative effectiveness trial of functional behavioral assessment methods

Call, N. A., Bernstein, A. M., O’Brien, M. J., Schieltz, K. M., Tsami, L., Lerman, D. C., Berg, W. K., Lindgren, S. D., Connelly, M. A., & Wacker, D. P. (2023) · Journal of Applied Behavior Analysis · doi:10.1002/jaba.1045 · Cited by 20 · see citing works

Robotic-assisted compared with laparoscopic incisional hernia repair following oncologic surgery: short- and long-term outcomes of a randomized controlled trial

Costa, T. N., Abdalla, R. Z., Tustumi, F., Ribeiro, U., & Cecconello, I. (2022) · Journal of Robotic Surgery · doi:10.1007/s11701-022-01403-y · Cited by 20 · see citing works

Behavioural therapy for shift work disorder improves shift workers' sleep, sleepiness and mental health: A pilot randomised control trial

Vallières, A., Pappathomas, A., Garnier, S. D. B., Mérette, C., Carrier, J., Paquette, T., & Bastien, C. H. (2024) · Journal of Sleep Research · doi:10.1111/jsr.14162 · Cited by 19 · see citing works

Does a combination treatment of repetitive transcranial magnetic stimulation and occupational therapy improve upper limb muscle paralysis equally in patients with chronic stroke caused by cerebral hemorrhage and infarction?

Tatsuno, H., Hamaguchi, T., Sasanuma, J., Kakita, K., Okamoto, T., Shimizu, M., Nakaya, N., & Abo, M. (2021) · Medicine · doi:10.1097/md.0000000000026339 · Cited by 19 · see citing works

A Personalized Remote Video-Feedback Universal Parenting Program: A Randomized Controlled Trial

Linhares, M. B. M., Altafim, E. R. P., Gaspardo, C. M., & de Oliveira, R. C. (2021) · Psychosocial Intervention · doi:10.5093/pi2021a9 · Cited by 19 · see citing works

Effect of walnut consumption on neuropsychological development in healthy adolescents: a multi-school randomised controlled trial

Pinar-Martí, A., Gignac, F., Fernández‐Barrés, S., Romaguera, D., Sala‐Vila, A., Lázaro, I., Ranzani, O., Persavento, C., Delgado, A., Carol, A., et al. (2023) · EClinicalMedicine · doi:10.1016/j.eclinm.2023.101954 · Cited by 19 · see citing works

Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in healthy adults in the USA: results of the booster phase of a randomised, controlled, phase 2 trial

Ghadge, S. K., Schneider, M., Dubischar, K. L., Wagner, L., Kadlecek, V., Obersriebnig, M., Hochreiter, R., Klingler, A., Larcher‐Senn, J., Derhaschnig, U., et al. (2024) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(24)00372-4 · Cited by 19 · see citing works

Effect of Plant-Derived n-3 Polyunsaturated Fatty Acids on Blood Lipids and Gut Microbiota: A Double-Blind Randomized Controlled Trial

Liu, H., Li, X., Zhu, Y., Huang, Y., Zhang, Q., Lin, S., Fang, C., Li, L., Lv, Y., Mei, W., et al. (2022) · Frontiers in Nutrition · doi:10.3389/fnut.2022.830960 · Cited by 17 · see citing works

Treatment of chronic lateral epicondylosis: a randomized trial comparing the efficacy of ultrasound-guided tendon dry needling and open-release surgery

Bureau, N. J., Tétreault, P., Grondin, P., Freire, V., Desmeules, F., Cloutier, G., Julien, A., & Choinière, M. (2022) · European Radiology · doi:10.1007/s00330-022-08794-4 · Cited by 17 · see citing works

Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants

D, M. F. M., Stahl, S. M., Pani, L., Martin, S. D., Cutler, A. J., Maletic, V., Gorodetzky, C. W., Vocci, F. J., Sapienza, F. L., Kosten, T. R., et al. (2024) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.24m15265 · Cited by 17 · see citing works

StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials

Lee, S. F., Shariati, S., Caini, S., Wong, H. C. Y., Chan, A. W., Gojsevic, M., Ogita, M., Ye, J. C., Chia, D., Chao, M., et al. (2023) · Supportive Care in Cancer · doi:10.1007/s00520-023-07983-1 · Cited by 16 · see citing works

Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression

Tsirmpas, C., Andrikopoulos, D., Fatouros, P., Eleftheriou, G., Anguera, J. A., Kontoangelos, K. A., & Papageorgiou, C. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2022.868970 · Cited by 14 · see citing works

The effects of visual art therapy on adults with depressive symptoms: A systematic review and meta‐analysis

Han, B., Jia, Y., Hu, G., Bai, L., Gains, H., You, S., He, R., Jiao, Y., Huang, K., Cui, L., et al. (2024) · International Journal of Mental Health Nursing · doi:10.1111/inm.13331 · Cited by 14 · see citing works

Telehealth vs in-person education for enhancing self-care of ostomy patients (Self-Stoma): Protocol for a noninferiority, randomized, open-label, controlled trial

Iovino, P., Vellone, E., Campoli, A., Tufano, C., Esposito, M. R., Guberti, M., Bolgeo, T., Sandroni, C., Sili, A., Manara, D. F., et al. (2024) · PLoS ONE · doi:10.1371/journal.pone.0303015 · Cited by 14 · see citing works

Future Directions in Clinical Trials and Intention-To-Treat Analysis: Fulfilling Admirable Intentions Through the Right Questions

Silverman, W. K., Pettit, J. W., & Jaccard, J. J. (2024) · Journal of Clinical Child & Adolescent Psychology · doi:10.1080/15374416.2024.2384035 · Cited by 14 · see citing works

Efficacy and safety of using a unilateral lower limb exoskeleton combined with conventional treatment in post-stroke rehabilitation: a randomized controlled trial

Jin, Y., Xiong, B., Chen, L., Zhao, W., Li, Z., Zhang, C., & Xu, X. (2024) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2024.1441986 · Cited by 14 · see citing works

Appraisal of Triglyceride-Related Markers as Early Predictors of Metabolic Outcomes in the PREVIEW Lifestyle Intervention: A Controlled Post-hoc Trial

Navas‐Carretero, S., San-Cristóbal, R., Vestentoft, P. S., Brand-Miller, J. C., Jalo, E., Westerterp‐Plantenga, M. S., Simpson, E. J., Handjieva‐Darlenska, T., Stratton, G., Huttunen‐Lenz, M., et al. (2021) · Frontiers in Nutrition · doi:10.3389/fnut.2021.733697 · Cited by 13 · see citing works

Effects of moderate-intensity aerobic exercise on serum BDNF and motor learning in the upper-limb in patients after chronic-stroke: A randomized, controlled feasibility study with embedded health economic evaluation

Maguire, C. C., Betschart, M., Pohl, J., Primani, F., Taeymans, J., & Hund‐Georgiadis, M. (2023) · Neurorehabilitation · doi:10.3233/nre-220239 · Cited by 13 · see citing works

Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial

(2023) · doi:10.2196/46989 · Cited by 13 · see citing works

Navigational Bronchoscopy vs CT Scan-Guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules

Lentz, R. J., Frederick-Dyer, K. C., Planz, V. B., Koyama, T., Aboudara, M. C., Swanner, B., Roller, L. J., Low, S., Salmon, C., Avasarala, S. K., et al. (2024) · CHEST Pulmonary · doi:10.1016/j.chpulm.2024.100050 · Cited by 13 · see citing works

Is the Mediterranean Low Fodmap Diet Effective in Managing Irritable Bowel Syndrome Symptoms and Gut Microbiota? An Innovative Research Protocol

Kasti, A. N., Katsas, K., Petsis, K., Lambrinou, S., Synodinou, K. D., Kapetani, A., Smart, K. L., Nikolaki, M. D., Halvatsiotis, P., Τriantafyllou, Κ., et al. (2024) · Nutrients · doi:10.3390/nu16111592 · Cited by 13 · see citing works

Efficacy of Voluntary Medical Male Circumcision to Prevent HIV Infection Among Men Who Have Sex With Men

Gao, Y., Zhan, Y., Sun, Y., Zheng, W., Zhang, W., Fu, L., Guo, Z., Lin, Y., Li, Y., Zheng, L., et al. (2024) · Annals of Internal Medicine · doi:10.7326/m23-3317 · Cited by 14 · see citing works

Can Healthy Checkout Counters Improve Food Purchases? Two Real-Life Experiments in Dutch Supermarkets

Huitink, M., Poelman, M. P., Seidell, J. C., Kuijper, L. D. J., Hoekstsra, T., & Dijkstra, S. C. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph17228611 · Cited by 13 · see citing works

Evaluation of a Physical-Psychological Integrative (PPI) intervention for community-dwelling spinal cord injury survivors: Study protocol of a preliminary randomized controlled trial

Li, Y., Wong, A., Chung, W. M., Li, M., Molasiotis, A., Bressington, D., Ma, C. Z.-H., Kor, P. P. K., & Yeung, W. F. (2023) · PLOS ONE · doi:10.1371/journal.pone.0282846 · Cited by 12 · see citing works

Designing digital health interventions with causal inference and multi-armed bandits: a review

Švihrová, R., Rossi, A. D., Marzorati, D., Tzovara, A., & Faraci, F. D. (2025) · Frontiers in Digital Health · doi:10.3389/fdgth.2025.1435917 · Cited by 12 · see citing works

Training coping skills and coping with stress self-efficacy for successful daily functioning and improved clinical status in patients with psychosis: A randomized controlled pilot study

Godoy‐Izquierdo, D., Pérez, M. L. V., Moreno, R. L., & García, J. F. G. (2021) · Science Progress · doi:10.1177/00368504211056818 · Cited by 12 · see citing works

On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease

Haas, S. K., Farjat, A. E., Pieper, K. S., Ageno, W., Angchaisuksiri, P., Bounameaux, H., Goldhaber, S. Z., Goto, S., Mantovani, L. G., Prandoni, P., et al. (2022) · TH Open · doi:10.1055/s-0042-1757744 · Cited by 12 · see citing works

Foreign language learning can improve response inhibition in individuals with lower baseline cognition: Results from a randomized controlled superiority trial

Grossmann, J. A., Aschenbrenner, S., Teichmann, B., & Meyer, P. (2023) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2023.1123185 · Cited by 13 · see citing works

Acupuncture for acute ischemic stroke: A systematic review and meta-analysis of randomized controlled trials

Huang, S., Wang, Y., Wu, Y., Huang, P., Dong, Y., Zhang, Q., Zhao, M., Zeng, J., Lu, L., & Liu, X. (2024) · Integrative Medicine Research · doi:10.1016/j.imr.2024.101092 · Cited by 12 · see citing works

Rhythm training improves word-reading in children with dyslexia

Descamps, M., Grossard, C., Pellerin, H., Lechevalier, C., Xavier, J., Matos, J., Vonthron, F., Grosmaître, C., Habib, M., Falissard, B., et al. (2025) · Scientific Reports · doi:10.1038/s41598-025-02485-y · Cited by 15 · see citing works

Research Question, Objectives, and Endpoints in Clinical and Oncological Research: A Comprehensive Review

singh, A. P., Shahapur, P. R., Vadakedath, S., Vallab Ganesh Bharadwaj, B., Kumar, D. P., Pinnelli, V. B., Godishala, V., & Kandi, V. (2022) · Cureus · doi:10.7759/cureus.29575 · Cited by 12 · see citing works

Extracorporeal Photopheresis as Graft-versus-Host Disease Prophylaxis: A Randomized Controlled Trial

Ali, M. M., Gedde‐Dahl, T., Osnes, L., Perrier, F., Veierød, M. B., Tjønnfjord, G. E., & Iversen, P. O. (2023) · Transplantation and Cellular Therapy · doi:10.1016/j.jtct.2023.02.023 · Cited by 12 · see citing works

Personalized training as a promoter for physical activity in people with depressive disorder—a randomized controlled trial in Germany

Keller-Varady, K., Haufe, S., Schieffer, E., Kerling, A., Tegtbur, U., & Kahl, K. G. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1158705 · Cited by 12 · see citing works

Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control

Stenlid, R., Cerenius, S. Y., Quan, W., Aydın, B. K., Manell, H., Chowdhury, A. I., Kristinsson, H., Ciba, I., Gjessing, E. S., Mörwald, K., et al. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2023.1293093 · Cited by 11 · see citing works

Clinical trial design and treatment effects: a meta-analysis of randomised controlled and single-arm trials supporting 437 FDA approvals of cancer drugs and indications

Michaeli, D. T., Michaeli, T., Albers, S., & Michaeli, J. C. (2024) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2023-112544 · Cited by 11 · see citing works

Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer: The ENSURE randomized controlled trial

Ezendam, N. P. M., de Rooij, B. H., Creutzberg, C. L., Kruitwagen, R. F. P. M., van Lonkhuijzen, L. R. C. W., Apperloo, M. J. A., Gerestein, C. G., Baalbergen, A., Boll, D., Vos, M. D., et al. (2024) · Gynecologic Oncology · doi:10.1016/j.ygyno.2024.06.020 · Cited by 11 · see citing works

Alcohol Approach Bias Is Associated With Both Behavioral and Neural Pavlovian-to-Instrumental Transfer Effects in Alcohol-Dependent Patients

Chen, K., Garbusow, M., Sebold, M., Kuitunen‐Paul, S., Smolka, M. N., Huys, Q. J. M., Zimmermann, U. S., Schlagenhauf, F., & Heinz, A. (2022) · Biological Psychiatry Global Open Science · doi:10.1016/j.bpsgos.2022.03.014 · Cited by 11 · see citing works

Pain Levels Did Not Differ Following Uncomplicated Third Molar Extractions Utilizing Liposomal Bupivacaine Versus Standard Bupivacaine

James, J., Benton, B., Faigen, A., Bloomquist, R. F., Farmaha, J. K., & Hollingsworth, C. (2022) · Journal of Oral and Maxillofacial Surgery · doi:10.1016/j.joms.2022.09.015 · Cited by 11 · see citing works

Sustainable-psycho-nutritional intervention programme for a sustainable diet (the ‘NutriSOS’ study) and its effects on eating behaviour, diet quality, nutritional status, physical activity, metabolic biomarkers, gut microbiota and water and carbon footprints in Mexican population: study protocol of an mHealth randomised controlled trial

Lares-Michel, M., Housni, F. E., Reyes-Castillo, Z., Huertas, J. R., Cervantes, V. G. A., & Nava, R. M. M. (2023) · British Journal Of Nutrition · doi:10.1017/s0007114523000843 · Cited by 11 · see citing works

The effect of mHealth program on behavior modification and health outcomes among patients with diabetes: A randomized controlled trial study

Firdaus, M. K. Z. H., Jittanoon, P., Boonyasopun, U., & Hasan, M. K. C. (2023) · Belitung Nursing Journal · doi:10.33546/bnj.2664 · Cited by 11 · see citing works

Effectiveness of Specific Health Check-ups in Japan for the primary prevention of obesity-related diseases: a protocol for a target trial emulation

Takeuchi, M., Shinozaki, T., & Kawakami, K. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-070417 · Cited by 9 · see citing works

Creatine supplementation does not add to resistance training effects in prostate cancer patients under androgen deprivation therapy: A double-blind randomized trial

Fairman, C. M., Kendall, K. L., Newton, R. U., Hart, N. H., Taaffe, D. R., López, P., Chee, R., Tang, C., & Galvao, D. A. (2024) · Journal of science and medicine in sport · doi:10.1016/j.jsams.2024.09.002 · Cited by 10 · see citing works

Effects of a home-based multicomponent exercise programme on frailty in post-cardiac surgery patients: a randomized controlled trial

Huang, W., Liu, C., Shih, C.-C., Chen, Y., Chou, C., Lee, J.-T., & Chiou, A. (2025) · European Journal of Cardiovascular Nursing · doi:10.1093/eurjcn/zvaf014 · Cited by 11 · see citing works

Enhancing Quality of Life in Patients With Hypothyroidism Using a Scientific Yoga Module: Randomized Controlled Trial

Nilkantham, S., Singh, A., Majumdar, V., Harini, K. N., & Snigdha, A. (2025) · Journal of Medical Internet Research · doi:10.2196/54078 · Cited by 12 · see citing works

Effects of transcranial direct current stimulation (tDCS) on motor function among people with stroke: evidence mapping

Qin, Y., Xu, J., & Ng, S. S. M. (2025) · Systematic Reviews · doi:10.1186/s13643-025-02795-2 · Cited by 10 · see citing works

GuitarPD: A Randomized Pilot Study on the Impact of Nontraditional Guitar Instruction on Functional Movement and Well‐Being in Parkinson’s Disease

Bastepe-Gray, S. E., Wainwright, L., Lanham, D. C., Gómez, G., Kim, J. S., Forshee, Z., Kaas, B. M., McCoy, A., McGregor, C., Moukheiber, E. S., et al. (2022) · Parkinson s Disease · doi:10.1155/2022/1061045 · Cited by 10 · see citing works

Saccharomyces boulardii and Lactulose for Childhood Functional Constipation: A Multicenter Randomized Controlled Trial

Lee, K. J., Ryoo, E., Lee, Y. M., Yoon, J. M., Jang, H.-J., Choi, S. Y., Choi, Y. J., Kim, H. J., Chung, J., & Shim, J. O. (2022) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm21130 · Cited by 10 · see citing works

Impact of Two Whole-Body Vibration Exercise Protocols on Body Composition of Patients with Metabolic Syndrome: A Randomized Controlled Trial

Reis-Silva, A., Coelho-Oliveira, A. C., dos Anjos, E. M., Moura-Fernandes, M. C., Mulder, A. D. R. P., Xavier, V. L., Mendonça, V. A., Lacerda, A. C. R., Paineiras-Domingos, L. L., Taïar, R., et al. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20010436 · Cited by 10 · see citing works

Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use

Wray, T. B., Chan, P. A., Kahler, C. W., Simpanen, E. M., & Nittas, V. (2023) · AIDS and Behavior · doi:10.1007/s10461-023-04223-9 · Cited by 9 · see citing works

Efficacy and safety of Vonoprazan-based treatment of Helicobacter pylori infection: a systematic review and network meta-analysis

Huang, S., Li, B., Pang, X.-Y., & Gao, W. (2024) · BMC Infectious Diseases · doi:10.1186/s12879-024-09885-x · Cited by 9 · see citing works

StrataXRT and Mepitel Film for Preventing Postmastectomy Acute Radiation Dermatitis in Breast Cancer: An Intrapatient Noninferiority Randomized Clinical Trial

Lee, S. F., Yip, P. L., Spencer, S., Ho, H., Subramanian, B., Ding, W., Lapuz, C., Foroudi, F., Kai, C., & Chao, M. (2024) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2024.11.076 · Cited by 9 · see citing works

A six-month prospective, randomised, double-blinded, placebo-controlled, crossover, dietary trial design to investigate the potential of psychobiotics on seizure semiology and comorbidities in canine epilepsy: study protocol

Schmidt, T., Meller, S., Meyerhoff, N., Twele, F., Zanghi, B. M., & Volk, H. A. (2023) · BMC Veterinary Research · doi:10.1186/s12917-023-03609-0 · Cited by 9 · see citing works

A blinded, randomized and controlled multicenter clinical trial to assess the efficacy and safety of Leisguard® as an immunotherapeutic treatment for healthy Leishmania infantum-seropositive dogs

Baxarias, M., Donato, G., Mateu, C., Salichs, M., Homedes, J. M., Miró, G., Pennisi, M. G., & Solano‐Gallego, L. (2023) · Parasites & Vectors · doi:10.1186/s13071-023-05903-0 · Cited by 9 · see citing works

A randomised controlled trial comparing internet-delivered cognitive behavioural therapy (iCBT) with and without main carer access versus treatment-as-usual for depression and anxiety among breast cancer survivors: Study protocol

Akkol-Solakoglu, S., Hevey, D., & Richards, D. (2021) · Internet Interventions · doi:10.1016/j.invent.2021.100367 · Cited by 8 · see citing works

Evaluating the effects of telenursing on patients' activities of daily living and instrumental activities of daily living after myocardial infarction: A randomized controlled trial study

Sefidi, N., Assarroudi, A., Zandi, Z., Malkemes, S. J., Rakhshani, M. H., Abbaszade, A., & Sahebkar, M. (2022) · Geriatrics and gerontology international/Geriatrics & gerontology international · doi:10.1111/ggi.14426 · Cited by 8 · see citing works

The effect of Tubigrip and a rigid belt on rectus abdominus diastasis immediately postpartum: A randomised clinical trial

Depledge, J., McNair, P. J., & Ellis, R. F. (2022) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2022.102712 · Cited by 8 · see citing works

Pain neuroscience education, blended exercises and booster sessions as an effective therapy for pain, functional and psychological factors in patients with knee osteoarthritis: a study protocol for a single-blind randomised controlled trial with 2 2 factorial design during 6-month follow-up

Gholami, Z., Faezi, S. T., Letafatkar, A., & Madreseh, E. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-070336 · Cited by 8 · see citing works

Efficacy of Silkworm Pupae Extract on Muscle Strength and Mass in Middle-Aged and Older Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial

Choi, J. I., Kweon, H., Lee, Y.-J., Lee, J., & Lee, S. Y. (2023) · The journal of nutrition health & aging · doi:10.1007/s12603-023-1942-9 · Cited by 8 · see citing works

Psychosocial Functioning in Transgender Youth after Hormones

Chen, D., Berona, J., & Olson-Kennedy, J. (2023) · New England Journal of Medicine · doi:10.1056/nejmc2302030 · Cited by 8 · see citing works

Efficacy of Hovenia dulcis Fruit Extract in Hangover Mitigation: Double-Blind Randomized Clinical Evaluation

Paik, D. H., Lee, K. W., Shim, Y. Y., Reaney, M. J. T., Park, I., Lee, S., Park, J.-Y., Park, E., Lee, S., Kim, I. A., et al. (2024) · Foods · doi:10.3390/foods13244084 · Cited by 7 · see citing works

The development and preliminary evaluation of a financial navigation program among patients with breast cancer in China

Yuan, X., Chen, L., Sun, Y., Kuang, Y., Ruan, J., Tang, L., Qiu, J., & Xing, W. (2025) · Asia-Pacific Journal of Oncology Nursing · doi:10.1016/j.apjon.2025.100668 · Cited by 7 · see citing works

Observed Correction

Bode, L., & Vraga, E. (2025) · doi:10.1093/oso/9780197565896.001.0001 · Cited by 7 · see citing works

Effectiveness of the ICCMS caries management system for children: a 3-year multicentre randomised controlled trial

Martignon, S., Cortés, A., Gamboa, L. F., Jácome‐Liévano, S., Arango-De-la-Cruz, M. C., Aguirre, O. L. C., Mesa, N. F., Martínez, K. R., Sanjuán, J., Alfaro, L., et al. (2022) · Acta Odontologica Scandinavica · doi:10.1080/00016357.2022.2038263 · Cited by 7 · see citing works

Is it safe enough? A pilot feasibility study of an 8-day intensive treatment for severe PTSD

Gahnfelt, H., Carlsson, P. F. G., & Blomdahl, C. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1200411 · Cited by 7 · see citing works

Effects of collaborative learning-based food literacy program on healthy eating behavior and hemoglobin A1c among older adults with uncontrolled type 2 diabetes: A randomized controlled trial study in Thailand

Saengrut, B., Panuthai, S., Chintanawat, R., & Suwankruhasn, N. (2024) · Belitung Nursing Journal · doi:10.33546/bnj.3482 · Cited by 6 · see citing works

Optimizing management of uncomplicated acute malnutrition in children in rural Niger: a 3-arm individually randomized, controlled, noninferiority trial

Daurès, M., Hien, J., Phelan, K. P. Q., Boubacar, H., Sanoussi, A., Aboubacar, M., Aly, A. A. M., Mayoum, B., Azani, J.-C., Koffi, J. J., et al. (2025) · American Journal of Clinical Nutrition · doi:10.1016/j.ajcnut.2025.07.004 · Cited by 6 · see citing works

Digital Intervention for behaviouR changE and Chronic disease prevenTION (DIRECTION): Study protocol for a randomized controlled trial of a web-based platform integrating nutrition, physical activity, and mindfulness for individuals with obesity

Orsso, C. E., Gormaz, T., Valentine, S., Trottier, C. F., de Sousa, I. M., Ferguson-Pell, M., Johnson, S. T., Kirkham, A. A., Klein, D., Maeda, N., et al. (2024) · Methods · doi:10.1016/j.ymeth.2024.09.009 · Cited by 6 · see citing works

Benefits of yoga in pregnancy: a randomised controlled clinical trial

Kuder, L., Dinevski, D., Dinevski, I. V., Takač, I., Mujezinović, F., & Gašparović, V. E. (2024) · Journal of Perinatal Medicine · doi:10.1515/jpm-2024-0422 · Cited by 13 · see citing works

Electromagnetic Induction for Treatment of Unspecific Back Pain: A Prospective Randomized Sham-Controlled Clinical Trial

Hartard, M., Fenneni, M. A., SCHARLA, S. H., Hartard, C., Hartard, D., Mueller, S., Mendez, G. B., & Saad, H. B. (2023) · Journal of Rehabilitation Medicine · doi:10.2340/jrm.v55.3487 · Cited by 6 · see citing works

Subject adherence

Jabbari, K., & Kaoutzanis, C. (2026) · Elsevier eBooks · doi:10.1016/b978-0-323-91168-9.00093-4

Intention-to-Treat vs. Per-Protocol Analyses: When and How -A Guide to the PerplexedPreprint

Pietrobon, R. S., Machiavelli, A., Rodrigues, L. P., Agrey, A., Nkeangnyi, L., Zechia, G., Lindenberg, A., Galvão, V., & Teixeira, L. (2026) · SSRN Electronic Journal · doi:10.2139/ssrn.6022875

Per-protocol analysis and intention-to-treat analysis

Suchmacher, M., & Geller, M. (2021) · Elsevier eBooks · doi:10.1016/b978-0-323-90102-4.00021-7

Intent to Treat Analysis vs. Per Protocol Analysis

Brody, T. (2012) · Elsevier eBooks · doi:10.1016/b978-0-12-391911-3.00008-6

Intent-to-Treat Analysis Versus Per Protocol Analysis

Brody, T. (2016) · Elsevier eBooks · doi:10.1016/b978-0-12-804217-5.00008-4 · Cited by 24 · see citing works