SPIRIT 2013: new guidance for content of clinical trial protocols

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., et al. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-3-201302050-00583 · Cited by 7,363 · see citing works

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

Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works

The prevention and treatment of missing data in clinical trials

Little, R. J., D'Agostino, R., Cohen, M. L., Dickersin, K., Emerson, S. S., Farrar, J. T., Frangakis, C., Hogan, J. W., Molenberghs, G., Murphy, S. A., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmsr1203730 · Cited by 1,884 · 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

Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa

Turner, L., Shamseer, L., Altman, D. G., Schulz, K. F., & Moher, D. (2012) · Systematic Reviews · doi:10.1186/2046-4053-1-60 · Cited by 628 · see citing works

Comparison of protocols and registry entries to published reports for randomised controlled trials

Dwan, K., Altman, D. G., Cresswell, L., Blundell, M., Gamble, C. L., & Williamson, P. R. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000031.pub2 · Cited by 243 · see citing works

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists

Smyth, R. M. D., Kirkham, J. J., Jacoby, A., Altman, D. G., Gamble, C., & Williamson, P. R. (2011) · BMJ · doi:10.1136/bmj.c7153 · Cited by 220 · see citing works

Adverse Event Reporting in Publications Compared With Sponsor Database for Cancer Clinical Trials

Scharf, O., & Colevas, A. D. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2005.05.3959 · Cited by 109 · see citing works

Guidelines for randomized clinical trial protocol content: a systematic review

Tetzlaff, J., Chan, A., Kitchen, J., Sampson, M., Tricco, A. C., & Moher, D. (2012) · Systematic Reviews · doi:10.1186/2046-4053-1-43 · Cited by 80 · see citing works

Measuring the Incidence, Causes, and Repercussions of Protocol Amendments

Getz, K. A., Zuckerman, R., Cropp, A. B., Hindle, A. L., Krauss, R., & Kaitin, K. I. (2011) · Drug Information Journal · doi:10.1177/009286151104500307 · Cited by 76 · see citing works

Developing a guideline for clinical trial protocol content: Delphi consensus survey

Tetzlaff, J., Moher, D., & Chan, A. (2012) · Trials · doi:10.1186/1745-6215-13-176 · Cited by 70 · see citing works

Comparison of protocols and registry entries to published reports for randomised controlled trials

Dwan, K. M., Altman, D. G., Blundell, M., Gamble, C. L., & Williamson, P. R. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000031 · Cited by 56 · see citing works

Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases

Bollyky, T. J., Cockburn, I., & Berndt, E. R. (2010) · Clinical Trials · doi:10.1177/1740774510386390 · Cited by 35 · see citing works

Access to data in industry-sponsored trials

Lundh, A., Krogsbøll, L. T., & Gøtzsche, P. C. (2011) · The Lancet · doi:10.1016/s0140-6736(11)61871-0 · Cited by 28 · see citing works

The activity of French Research Ethics Committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study

Decullier, É., Lhéritier, V., & Chapuis, F. R. (2005) · BMC Medical Ethics · doi:10.1186/1472-6939-6-9 · Cited by 24 · see citing works

Evaluation of clinical trials by Ethics Committees in Germany - Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA)

Russ, H., Busta, S., Riedel, A., Zöllner, G., & Jost, B. (2009) · PubMed Central · doi:10.3205/000066 · Cited by 13 · see citing works

Increasing value and reducing waste: addressing inaccessible research

Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., Gøtzsche, P. C., Krumholz, H. M., Ghersi, D., & van der Worp, H. B. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62296-5 · Cited by 887 · see citing works

Blockchain technology for improving clinical research quality

Benchoufi, M., & Ravaud, P. (2017) · Trials · doi:10.1186/s13063-017-2035-z · Cited by 369 · see citing works

Strategies to improve retention in randomised trials

Brueton, V. C., Tierney, J., Stenning, S., Harding, S., Meredith, S., Nazareth, I., & Rait, G. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000032.pub2 · Cited by 279 · see citing works

Sharing Clinical Trial Data

Lo, B. (2015) · JAMA · doi:10.1001/jama.2015.292 · Cited by 232 · see citing works

Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study

Chen, Y., Gao, Q., Zou, T., Wang, B., Liu, S., Sheng, J., Ren, J., Zou, X., Liu, Z., Song, Y., et al. (2020) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(19)30409-1 · Cited by 208 · see citing works

Quality Standards for Real-World Research. Focus on Observational Database Studies of Comparative Effectiveness

Roche, N., Reddel, H. K., Martin, R. J., Brusselle, G., Papi, A. A., Thomas, M. D., Postma, D., Thomas, V., Rand, C., Chisholm, A., et al. (2014) · Annals of the American Thoracic Society · doi:10.1513/annalsats.201309-300rm · Cited by 148 · see citing works

Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed

The CONSORT-AI and SPIRIT-AI Steering Group (2019) · Nature Medicine · doi:10.1038/s41591-019-0603-3 · Cited by 143 · see citing works

Strategies to improve retention in randomised trials

Gillies, K., Kearney, A., Keenan, C., Treweek, S. P., Hudson, J., Brueton, V. C., Conway, T., Hunter, A., Murphy, L., Carr, P. J., et al. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000032.pub3 · Cited by 142 · see citing works

Internet-based cognitive behavioural therapy for young people with suicide-related behaviour (Reframe-IT): A randomised controlled trial,”

Hetrick, S. E., Yuen, H. P., Bailey, E., Cox, G. R., Templer, K., Rice, S. M., Bendall, S., & Robinson, J. (2017) · Evidence-Based Mental Health · doi:10.1136/eb-2017-102719 · Cited by 124 · see citing works

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

Mayo-Wilson, E., Fusco, N., Li, T., Hong, H., Canner, J. K., & Dickersin, K. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.05.007 · Cited by 131 · see citing works

The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial

Faurholt‐Jepsen, M., Frost, M. M., Christensen, E. M., Bardram, J. E., Vinberg, M., & Kessing, L. V. (2019) · Psychological Medicine · doi:10.1017/s0033291719000710 · Cited by 129 · see citing works

The Alzheimer’s Prevention Initiative Generation Program: study design of two randomized controlled trials for individuals at risk for clinical onset of Alzheimer’s disease

Lopez Lopez, C., Tariot, P. N., Caputo, A., Langbaum, J. B., Liu, F., Riviere, M., Langlois, C., Rouzade‐Dominguez, M., Zalesak, M., Hendrix, S., et al. (2019) · Alzheimer's & Dementia: Translational Research & Clinical Interventions · doi:10.1016/j.trci.2019.02.005 · Cited by 116 · see citing works

The age-well randomized controlled trial of the Medit-ageing European project: effect of meditation or foreign language training on brain and mental health in older adults

Poisnel, G., Arenaza‐Urquijo, E., Collette, F., Klimecki, O. M., Marchant, N. L., Wirth, M., de La Sayette, V., Rauchs, G., Salmon, E., Vuilleumier, P., et al. (2018) · Alzheimer's & Dementia: Translational Research & Clinical Interventions · doi:10.1016/j.trci.2018.10.011 · Cited by 103 · see citing works

Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder—the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial

Faurholt‐Jepsen, M., Vinberg, M., Christensen, E. M., Frost, M. M., Bardram, J. E., & Kessing, L. V. (2013) · BMJ Open · doi:10.1136/bmjopen-2013-003353 · Cited by 91 · see citing works

Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones– the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial

Faurholt‐Jepsen, M., Vinberg, M., Frost, M. M., Christensen, E. M., Bardram, J. E., & Kessing, L. V. (2014) · BMC Psychiatry · doi:10.1186/s12888-014-0309-5 · Cited by 87 · see citing works

Promoting public access to clinical trial protocols: challenges and recommendations

Chan, A.-W., & Hróbjartsson, A. (2018) · Trials · doi:10.1186/s13063-018-2510-1 · Cited by 84 · see citing works

i-CONTENT tool for assessing therapeutic quality of exercise programs employed in randomised clinical trials

Hoogeboom, T. J., Kousemaker, M. C., van Meeteren, N. L., Howe, T., Bo, K., Tugwell, P., Ferreira, M., de Bie, R. A., van den Ende, C. H., & Stevens-Lapsley, J. E. (2021) · British Journal of Sports Medicine · doi:10.1136/bjsports-2019-101630 · Cited by 76 · see citing works

Artificial Intelligence in Drug Design: Algorithms, Applications, Challenges and Ethics

Arabi, A. A. (2021) · Future Drug Discovery · doi:10.4155/fdd-2020-0028 · Cited by 74 · see citing works

Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults—study protocol for a stepped-wedge cluster randomized trial (PAWEL Study)

PAWEL Study group, Sánchez, A., Thomas, C., Deeken, F., Wagner, S., Klöppel, S., Kentischer, F., Arnim, C. A. F. V., Denkinger, M. D., Conzelmann, L. O., et al. (2019) · Trials · doi:10.1186/s13063-018-3148-8 · Cited by 69 · see citing works

The PRECIS-2 tool has good interrater reliability and modest discriminant validity

Loudon, K., Zwarenstein, M., Sullivan, F., Donnan, P. T., Gágyor, I., Hobbelen, H. J. S. M., Althabe, F., Krishnan, J. A., & Treweek, S. P. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.06.001 · Cited by 67 · see citing works

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)

Moher, D., & Chan, A. (2014) · Guidelines for Reporting Health Research: A User's Manual · doi:10.1002/9781118715598.ch7 · Cited by 66 · see citing works

Cell-Based Therapies for Stroke: Are We There Yet?

Krause, M., Phan, T. G., Ma, H., Sobey, C. G., & Lim, R. (2019) · Frontiers in Neurology · doi:10.3389/fneur.2019.00656 · Cited by 66 · see citing works

SMARTphone and social media-based Cardiac Rehabilitation and Secondary Prevention (SMART-CR/SP) for patients with coronary heart disease in China: a randomised controlled trial protocol

Dorje, T., Zhao, G., Scheer, A., Tsokey, L., Wang, J., Chen, Y., Tso, K., Tan, B.-K., Ge, J., & Maiorana, A. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-021908 · Cited by 63 · see citing works

Evaluation of a Web-Based E-Learning Platform for Brief Motivational Interviewing by Nurses in Cardiovascular Care: A Pilot Study

Fontaine, G., Cossette, S., Heppell, S., Boyer, L., Mailhot, T., Simard, M.-J., & Tanguay, J. (2016) · Journal of Medical Internet Research · doi:10.2196/jmir.6298 · Cited by 58 · see citing works

A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial

For the Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group, Parker, M. J., Thabane, L., Fox‐Robichaud, A., Liaw, P. C., & Choong, K. L. M. (2016) · Trials · doi:10.1186/s13063-016-1689-2 · Cited by 52 · see citing works

Assessment of Adherence to Reporting Guidelines by Commonly Used Clinical Prediction Models From a Single Vendor

Lu, J., Callahan, A., Patel, B., Morse, K., Dash, D., Pfeffer, M. A., & Shah, N. H. (2022) · JAMA Network Open · doi:10.1001/jamanetworkopen.2022.27779 · Cited by 52 · see citing works

Continuing care for patients with alcohol use disorders: a systematic review.

Lenaerts, E., Matheï, C., Matthys, F., Zeeuws, D., Pas, L., Anderson, P., & Aertgeerts, B. (2014) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2013.10.030 · Cited by 45 · see citing works

Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial

Lyons, E., Baranowski, T., Basen-Engquist, K. M., Lewis, Z. H., Swartz, M. C., Jennings, K., & Volpi, E. (2016) · BMC Cancer · doi:10.1186/s12885-016-2244-y · Cited by 51 · see citing works

Artificial Intelligence-Powered Blockchains for Cardiovascular Medicine

Krittanawong, C., Aydar, M., Virk, H. U. H., Kumar, A., Kaplin, S. L., Guimaraes, L., Wang, Z., & Halperin, J. L. (2021) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2021.11.011 · Cited by 53 · see citing works

Selecting and measuring optimal outcomes for randomised controlled trials in surgery

Macefield, R. C., Boulind, C. E., & Blazeby, J. M. (2013) · Langenbeck s Archives of Surgery · doi:10.1007/s00423-013-1136-8 · Cited by 50 · see citing works

Janus kinase-1 and Janus kinase-2 inhibitors for treating myelofibrosis

Martí-Carvajal, A. J., Anand, V., & Solà, I. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010298.pub2 · Cited by 46 · see citing works

The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors

Qureshı, R., Gough, A., & Loudon, K. (2022) · Trials · doi:10.1186/s13063-022-06316-7 · Cited by 43 · see citing works

MYPLAN –mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial

Andreasson, K., Krogh, J., Bech, P., Frandsen, H., Buus, N., Stanley, B., Kerkhof, A. J. F. M., Nordentoft, M., & Erlangsen, A. (2017) · Trials · doi:10.1186/s13063-017-1876-9 · Cited by 42 · see citing works

Development of a universal approach to increase physical activity among adolescents: the GoActive intervention

Corder, K. L., Schiff, A., Kesten, J. M., & van Sluijs, E. M. F. (2015) · BMJ Open · doi:10.1136/bmjopen-2015-008610 · Cited by 42 · see citing works

The SCD‐Well randomized controlled trial: Effects of a mindfulness‐based intervention versus health education on mental health in patients with subjective cognitive decline (SCD)

Marchant, N. L., Barnhofer, T., Klimecki, O. M., Poisnel, G., Lutz, A., Arenaza‐Urquijo, E., Collette, F., Wirth, M., Schild, A., Coll‐Padrós, N., et al. (2018) · Alzheimer's & Dementia: Translational Research & Clinical Interventions · doi:10.1016/j.trci.2018.10.010 · Cited by 38 · see citing works

Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol Reporting Guidelines: Protocol for a Delphi Study

Mahajan, R., Burza, S., Bouter, L. M., Sijtsma, K., Knottnerus, J. A., Kleijnen, J., Dael, P. V., & Zeegers, M. P. (2020) · JMIR Research Protocols · doi:10.2196/17864 · Cited by 38 · see citing works

A multicentre, randomised, sham-controlled trial on REmote iSchemic conditioning In patients with acute STroke (RESIST) – Rationale and study design

Blauenfeldt, R. A., Hjort, N., Gude, M. F., Behrndtz, A. B., Fisher, M., Valentin, J. B., Kirkegaard, H., Johnsen, S. P., Hess, D. C., & Andersen, G. (2019) · European Stroke Journal · doi:10.1177/2396987319884408 · Cited by 37 · see citing works

Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial

Kanapathy, M., Hachach‐Haram, N., Bystrzonowski, N., Harding, K. G., Mosahebi, A., & Richards, T. (2016) · Trials · doi:10.1186/s13063-016-1352-y · Cited by 37 · see citing works

Adjuvant therapies in venous leg ulcer management: A scoping review

V. Team, Chandler, P. G., & Weller, C. (2019) · Wound Repair and Regeneration · doi:10.1111/wrr.12724 · Cited by 33 · see citing works

SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol

Yudi, M., Clark, D., Tsang, D., Jelinek, M. V., Kalten, K., Joshi, S. B., Phan, K., Nasis, A., Amerena, J. V., Arunothayaraj, S., et al. (2016) · BMC Cardiovascular Disorders · doi:10.1186/s12872-016-0356-6 · Cited by 35 · see citing works

A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial

Bernocchi, P., Scalvini, S., Galli, T., Paneroni, M., Baratti, D., Turla, O., Rovere, M. T. L., Volterrani, M., & Vitacca, M. (2016) · Trials · doi:10.1186/s13063-016-1584-x · Cited by 33 · see citing works

The effect of a low carbohydrate formula on glycaemia in critically ill enterally-fed adult patients with hyperglycaemia: A blinded randomised feasibility trial

Doola, R., Deane, A. M., Tolcher, D. M., Presneill, J., Barrett, H. L., Forbes, J. M., Todd, A. S., Okano, S., & Sturgess, D. J. (2019) · Clinical Nutrition ESPEN · doi:10.1016/j.clnesp.2019.02.013 · Cited by 35 · see citing works

TASCI—transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial

Birkhäuser, V., Liechti, M. D., Anderson, C. E., Bachmann, L. M., Baumann, S., Baumberger, M. E., Birder, L. A., Botter, S. M., Büeler, S., Cruz, C. D., et al. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-039164 · Cited by 32 · see citing works

Reducing dementia risk by targeting modifiable risk factors in mid-life: study protocol for the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) randomised controlled feasibility trial

In-MINDD Team, O’Donnell, C. A., Browne, S., Pierce, M., McConnachie, A., Deckers, K., van Boxtel, M. P. J., Manera, V., Köhler, S., Redmond, M., et al. (2015) · Pilot and Feasibility Studies · doi:10.1186/s40814-015-0035-x · Cited by 31 · see citing works

Technology-Delivered Psychotherapeutic Interventions in Improving Depressive Symptoms Among People with HIV/AIDS: A Systematic Review and Meta-analysis of Randomised Controlled Trials

Cheng, L. J., Kumar, P. A., Wong, S. N., & Lau, Y. (2019) · AIDS and Behavior · doi:10.1007/s10461-019-02691-6 · Cited by 31 · see citing works

An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules

Stegert, M., Kasenda, B., von Elm, E., You, J. J., Blümle, A., Tomonaga, Y., Saccilotto, R., Amstutz, A., Bengough, T., Briel, M., et al. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.05.023 · Cited by 30 · see citing works

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

Collaborators, Witt, C. M., Aickin, M. G., Cherkin, D. C., Che, C. T., Elder, C. R., Flower, A., Hammerschlag, R., Liu, J., Lao, L., et al. (2014) · Trials · doi:10.1186/1745-6215-15-169 · Cited by 28 · see citing works

Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment – the RADMIS trials: study protocol for two randomized controlled trials

Faurholt‐Jepsen, M., Frost, M. M., Martiny, K., Tuxen, N., Rosenberg, N., Busk, J., Winther, O., Bardram, J. E., & Kessing, L. V. (2017) · Trials · doi:10.1186/s13063-017-2015-3 · Cited by 28 · see citing works

Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial

Butti, N., Biffi, E., Genova, C., Romaniello, R., Redaelli, D. F., Reni, G., Borgatti, R., & Urgesi, C. (2020) · Trials · doi:10.1186/s13063-019-4001-4 · Cited by 27 · see citing works

Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

Kallestad, H., Vedaa, Ø., Scott, J. L., Morken, G., Pallesen, S., Harvey, A. G., Gehrman, P., Thorndike, F. P., Ritterband, L. M., Stiles, T. C., et al. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-025152 · Cited by 25 · see citing works

Endotoxin Removal in Septic Shock with the Alteco LPS Adsorber Was Safe But Showed no Benefit Compared to Placebo in the Double-Blind Randomized Controlled Trial—the Asset Study

Lipcsey, M., Tenhunen, J. J., Pischke, S. E., Kuitunen, A., Flaatten, H. K., Geer, L. D., Sjölin, J., Frithiof, R., Chew, M. S., Bendel, S., et al. (2019) · Shock · doi:10.1097/shk.0000000000001503 · Cited by 26 · see citing works

Get in the spirit with SPIRIT 2013: protocol content guideline for clinical trials

Schulz, K. F., & Grimes, D. A. (2013) · Contraception · doi:10.1016/j.contraception.2013.10.002 · Cited by 26 · see citing works

Effects of home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring in patients with chronic heart failure: a study protocol for a randomised controlled trial

Li, J., Yang, P., Fu, D., Ye, X., Zhang, L., Chen, G., Yang, Y., Luo, H., Chen, L., Shao, M., et al. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-023923 · Cited by 25 · see citing works

Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial

Murphy, J., Xie, H. W., Nguyen, V. C., Chau, L. W., Oanh, P. T. K., Tran, N. K., O’Neil, J., Goldsmith, C. H., Hoi, N. V., Ma, Y., et al. (2020) · International Journal of Mental Health Systems · doi:10.1186/s13033-020-00342-1 · Cited by 25 · see citing works

The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial

Lopez, M. G., Pretorius, M., Shotwell, M. S., Deegan, R., Eagle, S. S., Bennett, J. M., Sileshi, B., Liang, Y., Gelfand, B. J., Kingeter, A. J., et al. (2017) · Trials · doi:10.1186/s13063-017-2021-5 · Cited by 25 · see citing works

A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among adolescents aged 13–14 years

Brown, H. E., Whittle, F., Jong, S. T., Croxson, C. H. D., Sharp, S. J., Wilkinson, P. O., Wilson, E., van Sluijs, E. M. F., Vignoles, A. F., & Corder, K. L. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-014419 · Cited by 25 · see citing works

Quality standards in respiratory real-life effectiveness research: the REal Life EVidence AssessmeNt Tool (RELEVANT): report from the Respiratory Effectiveness Group—European Academy of Allergy and Clinical Immunology Task Force

Roche, N., Campbell, J. D., Krishnan, J. A., Brusselle, G., Chisholm, A., Bjermer, L. H., Thomas, M. D., Ganse, E. H. V., van den Berge, M., Christoff, G., et al. (2019) · Clinical and Translational Allergy · doi:10.1186/s13601-019-0255-x · Cited by 25 · see citing works

Wristband Accelerometers to motiVate arm Exercise after Stroke (WAVES): study protocol for a pilot randomized controlled trial

Moore, S. A., DaSilva, R., Balaam, M., Brkic, L., Jackson, D., Jamieson, D., Plötz, T., Rodgers, H., Shaw, L. C., van Wijck, F., et al. (2016) · Trials · doi:10.1186/s13063-016-1628-2 · Cited by 23 · see citing works

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

van den Boom, A. L., de Wijkerslooth, E. M. L., van Rosmalen, J., Beverdam, F. H., Boerma, E.-J. G., Boermeester, M. A., Bosmans, J. W. A. M., Burghgraef, T. A., Consten, E. C. J., Dawson, I., et al. (2018) · Trials · doi:10.1186/s13063-018-2629-0 · Cited by 23 · see citing works

A study protocol of Older Person’s Exercise and Nutrition Study (OPEN) - a sit-to-stand activity combined with oral protein supplement – effects on physical function and independence: a cluster randomized clinical trial

Grönstedt, H. K., Vikström, S., Cederholm, T., Franzén, E., Seiger, Å., Wimo, A. B., Irving, G. F., & Boström, A. (2018) · BMC Geriatrics · doi:10.1186/s12877-018-0824-1 · Cited by 23 · see citing works

Comparison Between Conventional Intervention and Non-immersive Virtual Reality in the Rehabilitation of Individuals in an Inpatient Unit for the Treatment of COVID-19: A Study Protocol for a Randomized Controlled Crossover Trial

da Silva, T. D., de Oliveira, P. M., Dionizio, J. B., de Santana, A. P., Bahadori, S., Dias, E. D., Ribeiro, C. M., Gomes, R. D. A., Ferreira, M., Ferreira, C., et al. (2021) · Frontiers in Psychology · doi:10.3389/fpsyg.2021.622618 · Cited by 23 · see citing works

Effectiveness of Exercise in Improving Sleep Outcomes among Perinatal Women: A Systematic Review and Meta-analysis of randomised Controlled Trials

Choong, S. Y. X., Tan, X. Y. J., Cheng, L. J., & Lau, Y. (2021) · Behavioral Sleep Medicine · doi:10.1080/15402002.2021.1931221 · Cited by 25 · see citing works

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial

Geest, S. D., Valenta, S., Ribaut, J., Gerull, S., Mielke, J., Simon, M., Bartáková, J., Kaier, K., Eckstein, J., Leppla, L., et al. (2022) · BMC Health Services Research · doi:10.1186/s12913-022-08293-8 · Cited by 25 · see citing works

On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss office-workers (NEXpro): protocol for a cluster-randomized controlled trial

Aegerter, A. M., Deforth, M. E., Johnston, V., Ernst, M. J., Volken, T., Luomajoki, H. A., Brunner, B., Dratva, J., Sjøgaard, G., Elfering, A., et al. (2020) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-020-03388-x · Cited by 23 · see citing works

DAHOS Study: Efficacy of dapagliflozin in treating heart failure with reduced ejection fraction and obstructive sleep apnea syndrome — A 3-month, multicenter, randomized controlled clinical trial

Xie, L., Li, S., Yu, X., Qin, W. D., Yu, F., & Tong, J. (2024) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-024-03643-3 · Cited by 22 · see citing works

Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol

Samuel, S. M., Dimitropoulos, G., Schraeder, K. E., Klarenbach, S. W., Nettel‐Aguirre, A., Guilcher, G. M. T., Pacaud, D., Pinzon, J. L., Lang, E., Andrew, G., et al. (2019) · BMJ Open · doi:10.1136/bmjopen-2019-034309 · Cited by 22 · see citing works

Healthy families: study protocol for a randomized controlled trial of a screening, brief intervention, and referral to treatment intervention for caregivers to reduce secondhand smoke exposure among pediatric emergency patients

Mahabee‐Gittens, E. M., Ammerman, R. T., Khoury, J. C., Stone, L., Meyers, G. T., Witry, J. K., Merianos, A. L., Mancuso, T. F., Stackpole, K., Bennett, B. L., et al. (2017) · BMC Public Health · doi:10.1186/s12889-017-4278-8 · Cited by 22 · see citing works

Youth depression alleviation: the Fish Oil Youth Depression Study ( YoDA ‐F): A randomized, double‐blind, placebo‐controlled treatment trial

Rice, S., Hickie, I. B., Yung, A. R., Mackinnon, A. J., Berk, M., Davey, C. G., Hermens, D. F., Hetrick, S. E., Parker, A. G., Schäfer, M. R., et al. (2014) · Early Intervention in Psychiatry · doi:10.1111/eip.12166 · Cited by 24 · see citing works

Ultrafiltration biofeedback guided by blood volume monitoring to reduce intradialytic hypotensive episodes in hemodialysis: study protocol for a randomized controlled trial

Leung, K. C. W., Quinn, R., Ravani, P., & MacRae, J. (2014) · Trials · doi:10.1186/1745-6215-15-483 · Cited by 26 · see citing works

Using discrete choice experiments as a decision aid in total knee arthroplasty: study protocol for a randomised controlled trial

Dowsey, M. M., Scott, A., Nelson, E. A., Li, J., Sundararajan, V., Nikpour, M., & Choong, P. (2016) · Trials · doi:10.1186/s13063-016-1536-5 · Cited by 21 · see citing works

Promoting adherence to treatment for latent TB infection through mobile phone text messaging: study protocol for a pilot randomized controlled trial

Oren, E., Bell, M. L., Garcia, F., Perez-Velez, C., & Gerald, L. B. (2017) · Pilot and Feasibility Studies · doi:10.1186/s40814-017-0128-9 · Cited by 20 · see citing works

The Foot Orthoses versus Hip eXercises (FOHX) trial for patellofemoral pain: a protocol for a randomized clinical trial to determine if foot mobility is associated with better outcomes from foot orthoses

Matthews, M., Rathleff, M. S., Claus, A. P., McPoil, T., Nee, R., Crossley, K. M., Kasza, J., Paul, S. K., Mellor, R., & Vicenzino, B. (2017) · Journal of Foot and Ankle Research · doi:10.1186/s13047-017-0186-5 · Cited by 20 · see citing works

Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial

Anderson, B. M., Dutton, M., Day, E., Jackson, T., Ferro, C. J., & Sharif, A. (2018) · Trials · doi:10.1186/s13063-018-2842-x · Cited by 20 · see citing works

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial

Rohr, M., Brandstetter, S., Bernardi, C., Fisser, C., Drewitz, K. P., Brunnthaler, V., Schmidt, K. F. R., Malfertheiner, M. V., & Apfelbacher, C. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00796-1 · Cited by 19 · see citing works

Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial

Price, J. T., Vwalika, B., Freeman, B. L., Cole, S. R., Mulenga, H. B., Winston, J., Mbewe, F., Chomba, E., MOFENSON, L. M., Rouse, D. J., et al. (2019) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-019-2224-8 · Cited by 19 · see citing works

Primary endpoint discrepancies were found in one in ten clinical drug trials. Results of an inception cohort study

van den Bogert, C. A., Souverein, P. C., Brekelmans, C. T. M., Janssen, S. W. J., Koëter, G. H., Leufkens, H. G. M., & Bouter, L. M. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.05.012 · Cited by 19 · see citing works

CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

Siskind, D. J., Friend, N., Russell, A. W., McGrath, J. J., Lim, C. C. W., Patterson, S., Flaws, D., STEDMAN, T. J., Moudgil, V., Sardinha, S., et al. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-021000 · Cited by 19 · see citing works

The citation of relevant systematic reviews and randomised trials in published reports of trial protocols

Pandis, N., Fleming, P. S., Koletsi, D., & Hopewell, S. (2016) · Trials · doi:10.1186/s13063-016-1713-6 · Cited by 18 · see citing works

Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial

Zou, T.-H., Gao, Q., Liu, S. D., Li, Y. Q., Meng, X. J., Zhang, G. X., Tian, Z. B., Zou, X. P., He, S., Hou, X. H., et al. (2024) · Journal of Digestive Diseases · doi:10.1111/1751-2980.13251 · Cited by 18 · see citing works

Development and validation of observational and qualitative study protocol reporting checklists for novice researchers (ObsQual checklist)

Low, G. K. K., Subedi, S., Omosumwen, O. F., Jiee, S. F., Devkota, S., Shanmuganathan, S., & Doyle, Z. (2024) · Evaluation and Program Planning · doi:10.1016/j.evalprogplan.2024.102468 · Cited by 18 · see citing works

“Everybody Brush!”: Protocol for a Parallel-Group Randomized Controlled Trial of a Family-Focused Primary Prevention Program With Distribution of Oral Hygiene Products and Education to Increase Frequency of Toothbrushing

Cunha‐Cruz, J., Milgrom, P., Shirtcliff, R. M., Huebner, C. E., Ludwig, S., Allen, G., & Scott, J. M. (2015) · JMIR Research Protocols · doi:10.2196/resprot.4485 · Cited by 18 · see citing works

Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial

Chen, L., Chiou, W., Lin, H., Lee, M., Lo, Y.-C., Huang, L., Chang, C., Hung, T., Lin, C.-W., Tseng, K., et al. (2019) · BMC Cancer · doi:10.1186/s12885-019-5461-3 · Cited by 18 · see citing works

Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence

Marsden, J., Anders, P., Clark, H., Colocassis, K., Eastwood, B., Knight, J., Melaugh, A., Quinn, D. I., Wright, V., & Stannard, J. (2020) · Trials · doi:10.1186/s13063-020-4099-4 · Cited by 18 · see citing works

The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial

Murphy, J., Goldsmith, C. H., Jones, W. R., Oanh, P. T. K., & Nguyen, V. C. (2017) · Trials · doi:10.1186/s13063-017-1924-5 · Cited by 18 · see citing works

Mobile health-based gamification intervention to increase physical activity participation among patients with coronary heart disease: study protocol of a randomised controlled trial

Xu, L., Li, J., Zhang, X., Pang, Y., Yu, T., Lian, X., Yu, T., Zhu, L., Tong, Q., & Li, F. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-054623 · Cited by 17 · see citing works

Abdominal Septic Shock – Endotoxin Adsorption Treatment (ASSET) – endotoxin removal in abdominal and urogenital septic shock with the Alteco® LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial

Lipcsey, M., Tenhunen, J. J., Sjölin, J., Frithiof, R., Bendel, S., Flaatten, H. K., Kawati, R., Kuitunen, A. H., Tønnessen, T. I., & Rubertsson, S. (2016) · Trials · doi:10.1186/s13063-016-1723-4 · Cited by 17 · see citing works

How to use the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) in orthodontic research

Novaes, I. C., Clementino, L. C., Flores‐Mir, C., Marques, L. S., & Martins‐Júnior, P. A. (2022) · Dental Press Journal of Orthodontics · doi:10.1590/2177-6709.27.3.e2220290.oar · Cited by 17 · see citing works

Effects of a community-based multicomponent rehabilitation programme for patients with fibromyalgia: protocol for a randomised controlled trial

Haugmark, T., Hagen, K. B., Provan, S. A., Bærheim, E., & Zangi, H. A. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-021004 · Cited by 16 · see citing works

Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial

Huang, B., Huang, Q., Hai, C., Zheng, Z., Li, Y., & Zhang, Z. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-024912 · Cited by 16 · see citing works

COGTIPS: a double-blind randomized active controlled trial protocol to study the effect of home-based, online cognitive training on cognition and brain networks in Parkinson’s disease

van Balkom, T. D., Berendse, H. W., van der Werf, Y. D., Twisk, J. W. R., Zijlstra, I., Hagen, R. H., Berk, T., Vriend, C., & van den Heuvel, O. A. (2019) · BMC Neurology · doi:10.1186/s12883-019-1403-6 · Cited by 16 · see citing works

<p>Abscess Drainage with or Without Antibiotics in Lactational Breast Abscess: Study Protocol for a Randomized Controlled Trial</p>

Luo, J., Long, T., Cai, Y., Teng, Y., Fan, Z., Liang, Z., Zhu, C., Ma, H., & Li, G. (2020) · Infection and Drug Resistance · doi:10.2147/idr.s221037 · Cited by 16 · see citing works

Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial

Liu, C., Kang, D., Xiao, J., Huang, Y., Peng, X., Wang, W., Xie, P., Yang, Y., Zhao, J., & Wu, R. (2021) · Trials · doi:10.1186/s13063-021-05123-w · Cited by 15 · see citing works

Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe)

Jones, J., Allen, S., Davies, J., Driscoll, T., Ellis, G., Fegan, G., Foster, T., Francis, N. A., Islam, S., Morgan, M. P. G., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-97979-w · Cited by 15 · see citing works

MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial

Kołodziejczyk-Nowotarska, A., Borszewska-Kornacka, M. K., & Seliga-Siwecka, J. P. (2017) · Trials · doi:10.1186/s13063-017-2141-y · Cited by 15 · see citing works

Perceptions about the implementation of physiotherapist prescribing in Australia: a national survey of Australian physiotherapists

Noblet, T., Marriott, J. F., Jones, T., Dean, C. M., & Rushton, A. B. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-024991 · Cited by 15 · see citing works

Implementation of guidelines on prevention of coercion and violence (PreVCo) in psychiatry: a multicentre randomised controlled trial

Steinert, T., Baumgardt, J., Bechdolf, A., Bühling‐Schindowski, F., Cole, C., Flammer, E., Jaeger, S., Junghanss, J., Kampmann, M., Mahler, L., et al. (2023) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2023.100770 · Cited by 14 · see citing works

Views and perceptions of Australian physiotherapists and physiotherapy students about the potential implementation of physiotherapist prescribing in Australia: a survey protocol

Noblet, T., Marriot, J., Jones, T., Dean, C. M., & Rushton, A. B. (2018) · BMC Health Services Research · doi:10.1186/s12913-018-3300-x · Cited by 14 · see citing works

Testing the effectiveness of REACH Pregnancy Circles group antenatal care: protocol for a randomised controlled pilot trial

Wiggins, M., Sawtell, M., Wiseman, O., McCourt, C., Greenberg, L., Hunter, R. M., Eldridge, S. M., Haora, P. J., Kaur, I., & Harden, A. (2018) · Pilot and Feasibility Studies · doi:10.1186/s40814-018-0361-x · Cited by 14 · see citing works

An Intervention to Increase Outdoor Play in Early Childhood Education Centers (PROmoting Early Childhood Outside): Protocol for a Pilot Wait-list Control Cluster Randomized Trial

Ramsden, R., Han, C. S. E., Mount, D., Loebach, J. E., Cox, A., Herrington, S., Bundy, A. C., Fyfe‐Johnson, A. L., Sandseter, E. B. H., Stone, M. R., et al. (2022) · JMIR Research Protocols · doi:10.2196/38365 · Cited by 15 · see citing works

Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol

Rantasalo, M., Palanne, R. A., Lahtinen, K., Kairaluoma, P. M., Linko, R., Reponen, E., Helkamaa, T., Vakkuri, A., Olkkola, K. T., Madanat, R., et al. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-025546 · Cited by 14 · see citing works

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., et al. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-3-201302050-00583 · Cited by 7,363 · see citing works

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

Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works

Principles of Protocol Development

Chen, B. E., Urton, A. M., Sadura, A., & Parulekar, W. R. (2022) · Springer eBooks · doi:10.1007/978-3-319-52636-2_32 · Cited by 2 · see citing works

What is a clinical trial protocol?

Cipriani, A., & Barbui, C. (2010) · Epidemiologia e Psichiatria Sociale · doi:10.1017/s1121189x00000804 · Cited by 10 · see citing works

SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials

Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works