Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)
Open accessAbstract
Objectives: Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist. Design: Repeated cross sectional study. Setting: Swiss, German and Canadian research ethics committees (RECs). Participants: RCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292). Primary and secondary outcome measures: The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reported Results: The median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%–79%) in 2012 to 77% (IQR, 68%–82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%–72%) in 2012 to 76% (IQR, 64%–83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%–80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship. Conclusions: In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Trial protocols vary in their completeness and often do not adequately describe important elements including primary outcomes, treatment allocation methods, blinding, adverse event measurement, sample size calculations, data analysis methods, dissemination policies, and roles of sponsors and investigators.
“However, trial protocols vary in their completeness and often do not address key elements of design and conduct.”
From SPIRIT 2025 statement: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
The reporting of protocols for randomised trials has improved somewhat since 2013 but remains far from adequate.
“Although the reporting of protocols for randomised trials has improved somewhat since 2013 it remains far from adequate.9 10 11 12”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In two samples of 108 and 292 trial protocols from 2016, 98% and 92% respectively reported steering committee membership and roles.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 98% and 92%, respectively, reported the steering committee membership and roles.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
The naming of authors and a description of their roles are standard for protocols published in journals such as Trials and BMJ Open, but they are less common for unpublished protocols.
“The naming of authors and a description of their roles are standard for protocols published in journals such as Trials and BMJ Open, but they are less common for unpublished protocols.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 61% and 39%, respectively, reported the role of the sponsor and funder.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 61% and 39%, respectively, reported the role of the sponsor and funder.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 57% and 78%, respectively, reported the name and contact details of the sponsor.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 57% and 78%, respectively, reported the name and contact details of the sponsor.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 unpublished trial protocols from 2016 found that 11% and 17%, respectively, reported the names of protocol contributors or authors.
“Reviews of two samples of 108 and 292 unpublished trial protocols from 2016 found that 11% and 17%, respectively, reported the names of protocol contributors or authors.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In two samples of 108 and 292 trial protocols from 2016, 23% and 32% respectively reported plans for who would have access to the full dataset.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 23% and 32%, respectively, reported plans for who would have access to the full dataset.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In two samples of 108 and 292 trial protocols from 2016, 65% and 62% respectively reported declarations of interests.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 65% and 62%, respectively, reported declarations of interests.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In two samples of 108 and 292 trial protocols from 2016, 91% and 83% respectively described funding sources.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 91% and 83%, respectively, described funding sources.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In two samples of 108 and 292 trial protocols from 2016, 44% and 26% respectively justified the research question.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 44% and 26%, respectively, justified the research question.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In two other samples of 108 and 292 protocols from 2016, plans to disseminate trial results were described in 56% and 71% respectively.
“In two other samples of 108 and 292 protocols from 2016, plans to disseminate trial results were described in 56% and 71%, respectively.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 83%, respectively, explained the choice of comparator.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 83%, respectively, explained the choice of comparator.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that patient eligibility criteria were reported in 100% of protocols.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that patient eligibility criteria were reported in 100% of protocols.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 42% and 56%, respectively, listed the countries where data were to be collected.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 42% and 56%, respectively, listed the countries where data were to be collected,”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 69% and 81%, respectively, reported the concomitant care that was permitted.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 69% and 81%, respectively, reported the concomitant care that was permitted.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that key elements of drug treatments (generic name, dose, and schedule of intervention) were reported in more than 90% of protocols.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that key elements of drug treatments (ie, generic name, dose, and schedule of intervention) were reported in more than 90% of protocols.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that strategies to improve adherence were addressed in 86% to 90%, respectively.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that strategies to improve adherence were addressed in 86% to 90%, respectively.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Eligibility criteria for care providers and centres in protocols for non-drug trials are often poorly reported.
“Eligibility criteria for care providers and centres in protocols for non-drug trials are often poorly reported.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 91% and 94%, respectively, described the specific objectives of the trial.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 91% and 94%, respectively, described the specific objectives of the trial.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that the specific measurement variable was reported in 89% to 97%, respectively, whereas fewer specified the analysis metric (83% to 90%) and time point of main interest (82% to 94%).
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that the specific measurement variable was reported in 89% to 97%, respectively, whereas fewer specified the analysis metric (83% to 90%) and time point of main interest (82% to 94%).9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 40% and 44% reported the location of participant recruitment.
“40% and 44% reported the location of participant recruitment,”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 90% and 91% described the setting of intervention delivery.
“and 90% and 91% described the setting of intervention delivery.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 82%, respectively, reported criteria for modification of interventions.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 82%, respectively, reported criteria for modification of interventions.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that eligibility criteria for centres (and criteria for those performing the intervention) were reported in 30% and 38% of protocols, respectively.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that eligibility criteria for centres (and criteria for those performing the intervention) were reported in 30% and 38% of protocols, respectively.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Although most trials will use strategies to promote enrolment of participants, this information is often incompletely reported in trial protocols.
“Although most trials will use strategies to promote enrolment of participants, this information is often incompletely reported in trial protocols.9 10 317”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 99% reported the estimated sample size but only 57% to 78%, respectively, reported the assumed outcome values involved.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 99% reported the estimated sample size but only 57% to 78%, respectively, reported the assumed outcome values involved.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 75% and 61%, respectively, described the method of sequence generation.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 75% and 61%, respectively, described the method of sequence generation.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that less than 44% of protocols reported the location of recruitment, individuals to be recruited, or expected recruitment rate.
“For example, reviews of two samples of 108 and 292 trial protocols from 2016 found that less than 44% of protocols reported the location of recruitment, individuals to be recruited, or expected recruitment rate.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 83% addressed the mechanism of allocation concealment.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 83% addressed the mechanism of allocation concealment.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Among protocols for randomised trials approved in 2016, 87% detailed the main analysis plan for the primary outcome.
“Among protocols for randomised trials approved in 2016, 87% detailed the main analysis plan for the primary outcome.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 reported that 69% and 74%, respectively, specified the analysis population.
“Reviews of two samples of 108 and 292 trial protocols from 2016 reported that 69% and 74%, respectively, specified the analysis population.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Despite the high prevalence and important effect of missing data, only 69% and 74% of two samples of trial protocols approved in 2016 considered statistical methods to handle missing data (and the analysis population relating to protocol non-adherence).
“Despite the high prevalence and important effect of missing data, only 69% and 74% of two samples of trial protocols approved in 2016 considered statistical methods to handle missing data (and the analysis population relating to protocol non-adherence).9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Trial monitoring was addressed in 13% to 76% of protocols approved in 2016 or published in 2019-20.
“Trial monitoring was addressed in 13% to 76% of protocols approved in 2016 or published in 2019-20.9 10 11 467”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 58% reported whether a data monitoring committee would or would not be planned.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 58% reported whether a data monitoring committee would or would not be planned.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols approved in 2016 found that 76% and 88%, respectively, considered confidentiality of data.
“Reviews of two samples of 108 and 292 trial protocols approved in 2016 found that 76% and 88%, respectively, considered confidentiality of data.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 56% and 32%, respectively, addressed ancillary and post-trial care.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 56% and 32%, respectively, addressed ancillary and post-trial care.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 15% to 18% of trial protocols approved in 2016 did not describe the process of obtaining informed consent.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 15% to 18% of trials protocols approved in 2016 did not describe the process of obtaining informed consent.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
In a sample of trial protocols approved in 2016, 66% to 77% reported how amendments would be handled.
“In a sample of trial protocols approved in 2016, 66% to 77% reported how amendments would be handled.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [9]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
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
Beta regression for modelling rates and proportions
Ferrari, S., & Cribari-Neto, F. (2004) · Journal of Applied Statistics · doi:10.1080/0266476042000214501 · Cited by 3,055 · see citing works
Babyak, M. A. (2004) · Psychosomatic Medicine · doi:10.1097/01.psy.0000127692.23278.a9 · Cited by 2,061 · see citing works
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
Prevalence, Characteristics, and Publication of Discontinued Randomized Trials
Kasenda, B., von Elm, E. B., You, J. J., Blümle, A., Tomonaga, Y., Saccilotto, R. T., Amstutz, A., Bengough, T., Meerpohl, J. J., Stegert, M., et al. (2014) · JAMA · doi:10.1001/jama.2014.1361 · Cited by 416 · see citing works
Self-citationComparison 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
Pildal, J., Chan, A.-W., Hróbjartsson, A., Forfang, E., Altman, D. G., & Gøtzsche, P. C. (2005) · BMJ · doi:10.1136/bmj.38414.422650.8f · Cited by 209 · see citing works
Fate of biomedical research protocols and publication bias in France: retrospective cohort study
Decullier, É., Lhéritier, V., & Chapuis, F. R. (2005) · BMJ · doi:10.1136/bmj.38488.385995.8f · Cited by 153 · see citing works
Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet
Al-Marzouki, S., Roberts, I., Evans, S., & Marshall, T. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61060-0 · Cited by 119 · 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
Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols
Kyte, D., Duffy, H., Fletcher, B., Gheorghe, A., Mercieca-Bebber, R., King, M., Draper, H., Ives, J., Brundage, M., Blazeby, J., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0110229 · Cited by 82 · 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
The Impact of Protocol Amendments on Clinical Trial Performance and Cost
Getz, K. A., Stergiopoulos, S., Short, M., Surgeon, L., Krauss, R., Pretorius, S., Desmond, J., & Dunn, D. (2016) · Therapeutic Innovation & Regulatory Science · doi:10.1177/2168479016632271 · Cited by 72 · see citing works
Hróbjartsson, A., Pildal, J., Chan, A.-W., Haahr, M. T., Altman, D. G., & Gøtzsche, P. C. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.04.003 · Cited by 56 · 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
Worldwide trends in volume and quality of published protocols of randomized controlled trials
van Rosmalen, B. V., Alldinger, I., Cieslak, K. P., Wennink, R. A. W., Clarke, M. J., Ali, U. A., & Besselink, M. G. (2017) · PLoS ONE · doi:10.1371/journal.pone.0173042 · Cited by 25 · see citing works
Ahmed, K., Kyte, D. G., Keeley, T., Efficace, F., Armes, J., Brown, J. M., Calman, L. A., Copland, C., Gavin, A., Glaser, A., et al. (2016) · BMJ Open · doi:10.1136/bmjopen-2016-012863 · Cited by 24 · see citing works
van Lent, M., Rongen, G. A. P. J. M., & Out, H. J. (2014) · BMC Medical Ethics · doi:10.1186/1472-6939-15-83 · Cited by 20 · see citing works
Gryaznov, D., Odutayo, A., von Niederhäusern, B., Speich, B., Kasenda, B., Ojeda–Ruiz, E., Blümle, A., Schandelmaier, S., Mertz, D., Tomonaga, Y., et al. (2020) · Trials · doi:10.1186/s13063-020-04808-y · Cited by 15 · see citing works
Self-citationMadden, K., Arseneau, E., Evaniew, N., Smith, C., & Thabane, L. (2016) · BMJ Open · doi:10.1136/bmjopen-2016-011188 · Cited by 13 · see citing works
Kyte, D. G., Draper, H., Ives, J., et al. (2014) · PLoS ONE · doi:10.1371/annotation/e7d2b920-2c2a-425e-b500-982cd72f4d64 · Cited by 11 · see citing works
Reporting quality of stepped wedge design randomized trials: a systematic review protocol
Thabane, L., Thabane, A., Dennis, B. B., Gajic‐Veljanoski, O., & Paul, J. (2016) · Clinical Epidemiology · doi:10.2147/clep.s103098 · Cited by 8 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
SPIRIT 2025 statement: updated guideline for protocols of randomised trials
Chan, A.-W., 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-2024-081477 · Cited by 460 · see citing works
Self-citationSPIRIT 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
Self-citationSpeich, B., Gryaznov, D., Busse, J. W., Gloy, V. L., Lohner, S., Klatte, K., Taji Heravi, A., Ghosh, N., Lee, H., Mansouri, A., et al. (2022) · PLOS Medicine · doi:10.1371/journal.pmed.1003980 · Cited by 69 · see citing works
Self-citationSpeich, B., Mann, E., Schönenberger, C. M., Mellor, K., Griessbach, A. N., Dhiman, P., Gandhi, P., Lohner, S., Agarwal, A., Odutayo, A., et al. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.17651 · Cited by 41 · see citing works
Self-citationSpeich, B., Odutayo, A., Peckham, N., Ooms, A., Stokes, J. R., Saccilotto, R., Gryaznov, D., von Niederhäusern, B., Copsey, B., Altman, D. G., et al. (2022) · Trials · doi:10.1186/s13063-022-06516-1 · Cited by 21 · see citing works
Self-citation
- Authors
- Gryaznov, D., von Niederhäusern, B., Speich, B., Kasenda, B., Ojeda-Ruiz, E., Blümle, A., Schandelmaier, S., Mertz, D., Odutayo, A., Tomonaga, Y., Amstutz, A., Pauli-Magnus, C., Gloy, V., Lohner, S., Bischoff, K., Wollmann, K., Rehner, L., Meerpohl, J. J., Nordmann, A., Klatte, K., Ghosh, N., Taji Heravi, A., Wong, J., Chow, N., Hong, P., McCord - De Iaco, K. A., Sricharoenchai, S., Busse, J. W., Agarwal, A., Saccilotto, R., Schwenkglenks, M., Moffa, G., Hemkens, L., Hopewell, S., Von Elm, E., & Briel, M.
- Affiliations
- University of Basel (CH)
- Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland
- Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
- University of Freiburg (DE)
- McMaster University (CA)
- University of Oxford (GB)
- University of Zurich (CH)
- University of Pecs (HU)
- Canadian Memorial Chiropractic College (CA)
- University of Ottawa (CA)
- Cochrane Switzerland, Centre for Primary Care and Public Health (unisanté), University of Lausanne, Lausanne, Switzerland
- Corresponding author
- Briel, Matthias
- ORCID
- Gryaznov, Dmitry
- Speich, Benjamin
- Kasenda, Benjamin
- Ojeda-Ruiz, Elena
- Blümle, Anette
- Schandelmaier, Stefan
- Mertz, Dominik
- Odutayo, Ayodele
- Tomonaga, Yuki
- Amstutz, Alain
- Gloy, Viktoria
- Lohner, Szimonetta
- Bischoff, Karin
- Wollmann, Katharina
- Rehner, Laura
- Meerpohl, Joerg J
- Ghosh, Nilabh
- Wong, Jacqueline
- Chow, Ngai
- Sricharoenchai, Sirintip
- Busse, Jason W
- Agarwal, Arnav
- Saccilotto, Ramon
- Schwenkglenks, Matthias
- Moffa, Giusi
- Hemkens, Lars
- Hopewell, Sally
- Von Elm, Erik
- Briel, Matthias
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2022-05
- Volume
- 12
- Issue
- 5
- Pages
- e053417
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC9125701
- OpenAlex
- W4281479985
- Cited by
- 22
- References
- 26
- Citations by year
- 2026: 2 · 2025: 13 · 2024: 3 · 2023: 1 · 2022: 3
- FWCI
- 3.01
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion, cc-by-nc)
- Explore Bristol Research (publishedVersion, cc-by-nc)
- SERVAL (Université de Lausanne) (publishedVersion, cc-by-nc)
- edoc (University of Basel) (acceptedVersion)
- IRIS (submittedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by-nc)
- Funders
- Swiss National Science Foundation ((P300PB_177933))
- Swiss Federal Office of Public Health (No grant number)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- SPIRIT checklist, reporting quality, randomized controlled trials, research ethics committees, industry-sponsored trials, clinical trial units, contract research organizations, trial characteristics
- MeSH terms
- Canada, Cross-Sectional Studies, Germany, Humans, Switzerland, Ethics Committees, Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
