Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) : extending the CONSORT statement

Reporting guideline provided for? (i.e. exactly what the authors state in the paper)

Interventions in clinical trials of acupuncture

 

Full bibliographic reference

MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261.

Language

English

PubMed ID

20543992

Relevant URLs (full-text if available)

The STRICTA checklist is available from the STRICTA website.

Availability in additional languages

The STRICTA statement has been translated into the following languages: Chinese; Japanese; Korean; Russian. 
Please visit the following URL for more information and full-text downloads: http://www.stricta.info/translations.htm

Visit our translations page to find out what other reporting guidelines are available in languages other than English: reporting guideline translations

Relevant more generic / specialised reporting guidelines (i.e. main generic guideline or extension to a generic guideline)

**Generic

CONSORT 2025 Statement**: Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials.

BMJ. 2025; 388:e081123.PMID:40228833

JAMA. 2025.PMID: 40228499

Lancet. 2025.PMID: 40245901

Nat Med. 2025.PMID: 40229553

PLoS Med. 2025; 22(4): e1004587.PMID:40228477

Specialised

CONSORT Harms: Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, Li T, Mayo-Wilson E, Pham B, Phillips R, Santaguida P, Scherer RW, Gøtzsche PC, Moher D, Ioannidis JPA, Vohra S; CONSORT Harms Group. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials.

BMJ. 2023;381:e073725. PMID: 37094878

J Clin Epidemiol. 2023:S0895-4356(23)00090-2. PMID: 37100738

CONSORT Non-inferiority:  Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604. PMID: 23268518

CONSORT Cluster:  Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. PMID: 22951546

CONSORT Herbal:  Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT Statement. Ann Intern Med. 2006;144(5):364-367. PMID: 16520478

CONSORT Non-pharmacological treatment interventions: Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40-47. PMID: 28630973

CONSORT Abstracts:  Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1):e20. PMID: 18215107

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371(9609):281-283. PMID: 18221781

CONSORT Pragmatic Trials: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. PMID: 19001484

CONSORT PRO: Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814-822. PMID: 23443445

CONSORT-CENT: Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT group. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.BMJ. 2015;350:h1738.  PMID: 25976398

CONSORT for orthodontic trials: Pandis N, Fleming PS, Hopewell S, Altman DG. The CONSORT Statement: Application within and adaptations for orthodontic trials. Am J Orthod Dentofacial Orthop. 2015;147(6):663-679. PMID: 26038070

TIDieR: Hoffmann T, Glasziou P, Boutron I, Milne R, Perera R, Moher D, Altman D, Barbour V, Macdonald H, Johnston M, Lamb S, Dixon-Woods M, McCulloch P, Wyatt J, Chan A, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. PMID: 24609605

Simulation Research: Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M; International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators. Reporting Guidelines for Health Care Simulation Research: Extensions to the CONSORT and STROBE Statements. Simul Healthc. 2016;11(4):238-248. PMID: 27465839

CONSORT for pilot and feasibility trials: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; on behalf of the PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Stud. 2016;2:64. PMID: 27965879

CONSORT-CHM formulas: Cheng C-W, Wu T-X, Shang H-C, Li Y-P, Altman DG, Moher D, Bian Z-X; for the CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. 2017. Ann Intern Med. Link to full-text.

CONSORT for within person randomised trials: Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017;357:j2835. PMID: 28667088

CONSORT Equity: Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P; CONSORT-Equity and Boston Equity Symposium. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ. 2017;359:j5085. PMID: 29170161

CONSORT-SPI: Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; on behalf of the CONSORT-SPI Group. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018;19:407. PMID: 30060754

Stepped wedge cluster randomised trials: Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. PMID: 30413417

CONSORT for multi-arm parallel-group randomised trials: Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019;321(16):1610-1620. PMID: 31012939

CONSORT 2010 extension to randomised crossover trials: Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019;366:l4378. PMID: 31366597

CENT for TCM: Li J, Hu JY, Zhai JB, Niu JQ, Kwong JSW, Ge L, Li B, Wang Q, Wang XQ, Wei D, Tian JH, Ma B, Yang KH, Dai M, Tian GH, Shang HC; CENT for TCM Working Group. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): Recommendations, explanation and elaboration. Complement Ther Med. 2019;46:180-188. PMID: 31519276

STRICTOC: Zhang X, Tian R, Lam WC, Duan Y, Liu F, Zhao C, Wu T, Shang H, Tang X, Lyu A, Bian Z. Standards for reporting interventions in clinical trials of cupping (STRICTOC): extending the CONSORT statement. Chin Med. 2020;15:10. PMID: 32021646

ACE Statement: Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

BMJ. 2020;369:m115. PMID: 32554564

Trials. 2020;21(1):528. PMID: 32546273

CONSORT-AI: Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK; on behalf of the SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension.

BMJ 2020;370:m3164. PMID: 32909959

Nat Med. 2020:26(9):1364–1374. PMID: 32908283

Lancet Digital Health. 2020;2(10):e537-e548. PMID: 33328048

CONSORT-ROUTINE: Kwakkenbos L, Imran M, McCall SJ, McCord KA, Fröbert O, Hemkens LG, Zwarenstein M, Relton C, Rice DB, Langan SM, Benchimol EI, Thabane L, Campbell MK, Sampson M, Erlinge D, Verkooijen HM, Moher D, Boutron I, Ravaud P, Nicholl J, Uher R, Sauvé M, Fletcher J, Torgerson D, Gale C, Juszczak E, Thombs BD. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ. 2021;373:n857. PMID: 33926904

CONSORT-Outcomes: Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022;328(22):2252-2264. PMID: 36511921

CONSORT-DEFINE: Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Hopewell S, Ursino M, Rantell KR, Calvert M, Lee S, Kightley A, Ashby D, Chan AW, Garrett-Mayer E, Isaacs JD, Golub R, Kholmanskikh O, Richards D, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, Dimairo M, Weir CJ. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. BMJ. 2023;383:e076387. PMID: 37863501

CONSORT Factorial: Kahan BC, Hall SS, Beller EM, Birchenall M, Chan AW, Elbourne D, Little P, Fletcher J, Golub RM, Goulao B, Hopewell S, Islam N, Zwarenstein M, Juszczak E, Montgomery AA. Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2023;330(21):2106-2114. PMID: 38051324

CONSORT-Surrogate: Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Blazeby J, Butcher NJ, Bujkiewicz S, Chan AW, Dawoud D, Offringa M, Ouwens M, Hróbjartssson A, Amstutz A, Bertolaccini L, Bruno VD, Devane D, Faria CDCM, Gilbert PB, Harris R, Lassere M, Marinelli L, Markham S, Powers JH 3rd, Rezaei Y, Richert L, Schwendicke F, Tereshchenko LG, Thoma A, Turan A, Worrall A, Christensen R, Collins GS, Ross JS, Taylor RS, Ciani O. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. BMJ. 2024;386:e078524. PMID: 38981645

CONSORT-iNeurostim: Duarte RV, Bresnahan R, Copley S, Eldabe S, Thomson S, North RB, Baranidharan G, Levy RM, Collins GS, Taylor RS. Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension. EClinicalMedicine. 2024;78:102932. PMID: 39606687

CONSORT CRXO: McKenzie JE, Taljaard M, Hemming K, Arnup SJ, Giraudeau B, Eldridge S, Hooper R, Kahan BC, Li T, Moher D, Turner EL, Grimshaw JM, Forbes AB. Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2025;388:e080472. PMID: 39761979

Reporting guideline website URL

http://www.stricta.info/

Reporting guideline acronym

STRICTA

Study design

Clinical trials, Experimental studies

Clinical area

Complementary and alternative medicine

Applies to the whole report or to individual sections of the report?

Whole report

Previous versions of this guideline / Guideline history

This revised guidance replaces STRICTA 2001 (PMID: 12184354 , PMID: 11926601, PMID: 11890439)

Record last updated on

May 30, 2025

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Reporting Guidelines are recommendations to help describe your work clearly

Your research will be used by people from different disciplines and backgrounds for decades to come. Reporting guidelines list the information you should describe so that everyone can understand, replicate, and synthesise your work.

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You work will be read by different people, for different reasons, around the world, and for decades to come. Reporting guidelines help you consider all of your potential audiences. For example, your research may be read by researchers from different fields, by clinicians, patients, evidence synthesisers, peer reviewers, or editors. Your readers will need information to understand, to replicate, apply, appraise, synthesise, and use your work.

Cohort studies

A cohort study is an observational study in which a group of people with a particular exposure (e.g. a putative risk factor or protective factor) and a group of people without this exposure are followed over time. The outcomes of the people in the exposed group are compared to the outcomes of the people in the unexposed group to see if the exposure is associated with particular outcomes (e.g. getting cancer or length of life).

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Case-control studies

A case-control study is a research method used in healthcare to investigate potential risk factors for a specific disease. It involves comparing individuals who have been diagnosed with the disease (cases) to those who have not (controls). By analysing the differences between the two groups, researchers can identify factors that may contribute to the development of the disease.

An example would be when researchers conducted a case-control study examining whether exposure to diesel exhaust particles increases the risk of respiratory disease in underground miners. Cases included miners diagnosed with respiratory disease, while controls were miners without respiratory disease. Participants' past occupational exposures to diesel exhaust particles were evaluated to compare exposure rates between cases and controls.

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Cross-sectional studies

A cross-sectional study (also sometimes called a "cross-sectional survey") serves as an observational tool, where researchers capture data from a cohort of participants at a singular point. This approach provides a 'snapshot'— a brief glimpse into the characteristics or outcomes prevalent within a designated population at that precise point in time. The primary aim here is not to track changes or developments over an extended period but to assess and quantify the current situation regarding specific variables or conditions. Such a methodology is instrumental in identifying patterns or correlations among various factors within the population, providing a basis for further, more detailed investigation.

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Systematic reviews

A systematic review is a comprehensive approach designed to identify, evaluate, and synthesise all available evidence relevant to a specific research question. In essence, it collects all possible studies related to a given topic and design, and reviews and analyses their results.

The process involves a highly sensitive search strategy to ensure that as much pertinent information as possible is gathered. Once collected, this evidence is often critically appraised to assess its quality and relevance, ensuring that conclusions drawn are based on robust data. Systematic reviews often involve defining inclusion and exclusion criteria, which help to focus the analysis on the most relevant studies, ultimately synthesising the findings into a coherent narrative or statistical synthesis. Some systematic reviews will include a [meta-analysis]{.defined data-bs-toggle="offcanvas" href="#glossaryItemmeta_analyses" aria-controls="offcanvasExample" role="button"}.

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Systematic review protocols

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Meta analyses of Observational Studies

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Randomised Trials

A randomised controlled trial (RCT) is a trial in which participants are randomly assigned to one of two or more groups: the experimental group or groups receive the intervention or interventions being tested; the comparison group (control group) receive usual care or no treatment or a placebo. The groups are then followed up to see if there are any differences between the results. This helps in assessing the effectiveness of the intervention.

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Randomised Trial Protocols

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Qualitative research

Research that aims to gather and analyse non-numerical (descriptive) data in order to gain an understanding of individuals' social reality, including understanding their attitudes, beliefs, and motivation. This type of research typically involves in-depth interviews, focus groups, or field observations in order to collect data that is rich in detail and context. Qualitative research is often used to explore complex phenomena or to gain insight into people's experiences and perspectives on a particular topic. It is particularly useful when researchers want to understand the meaning that people attach to their experiences or when they want to uncover the underlying reasons for people's behaviour. Qualitative methods include ethnography, grounded theory, discourse analysis, and interpretative phenomenological analysis.

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Case Reports

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Diagnostic Test Accuracy Studies

Diagnostic accuracy studies focus on estimating the ability of the test(s) to correctly identify people with a predefined target condition, or the condition of interest (sensitivity) as well as to clearly identify those without the condition (specificity).

Prediction Models

Prediction model research is used to test the accurarcy of a model or test in estimating an outcome value or risk. Most models estimate the probability of the presence of a particular health condition (diagnostic) or whether a particular outcome will occur in the future (prognostic). Prediction models are used to support clinical decision making, such as whether to refer patients for further testing, monitor disease deterioration or treatment effects, or initiate treatment or lifestyle changes. Examples of well known prediction models include EuroSCORE II for cardiac surgery, the Gail model for breast cancer, the Framingham risk score for cardiovascular disease, IMPACT for traumatic brain injury, and FRAX for osteoporotic and hip fractures.

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Animal Research

TODO

Quality Improvement in Healthcare

Quality improvement research is about finding out how to improve and make changes in the most effective way. It is about systematically and rigourously exploring "what works" to improve quality in healthcare and the best ways to measure and disseminate this to ensure positive change. Most quality improvement effectiveness research is conducted in hospital settings, is focused on multiple quality improvement interventions, and uses process measures as outcomes. There is a great deal of variation in the research designs used to examine quality improvement effectiveness.

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Economic Evaluations in Healthcare

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Meta Analyses

A meta-analysis is a statistical technique that amalgamates data from multiple studies to yield a single estimate of the effect size. This approach enhances precision and offers a more comprehensive understanding by integrating quantitative findings. Central to a meta-analysis is the evaluation of heterogeneity, which examines variations in study outcomes to ensure that differences in populations, interventions, or methodologies do not skew results. Techniques such as meta-regression or subgroup analysis are frequently employed to explore how various factors might influence the outcomes. This method is particularly effective when aiming to quantify the effect size, odds ratio, or risk ratio, providing a clearer numerical estimate that can significantly inform clinical or policy decisions.

How Meta-analyses and Systematic Reviews Work Together

Systematic reviews and meta-analyses function together, each complementing the other to provide a more robust understanding of research evidence. A systematic review meticulously gathers and evaluates all pertinent studies, establishing a solid foundation of qualitative and quantitative data. Within this framework, if the collected data exhibit sufficient homogeneity, a meta-analysis can be performed. This statistical synthesis allows for the integration of quantitative results from individual studies, producing a unified estimate of effect size. Techniques such as meta-regression or subgroup analysis may further refine these findings, elucidating how different variables impact the overall outcome. By combining these methodologies, researchers can achieve both a comprehensive narrative synthesis and a precise quantitative measure, enhancing the reliability and applicability of their conclusions. This integrated approach ensures that the findings are not only well-rounded but also statistically robust, providing greater confidence in the evidence base.

Why Don't All Systematic Reviews Use a Meta-Analysis?

Systematic reviews do not always have meta-analyses, due to variations in the data. For a meta-analysis to be viable, the data from different studies must be sufficiently similar, or homogeneous, in terms of design, population, and interventions. When the data shows significant heterogeneity, meaning there are considerable differences among the studies, combining them could lead to skewed or misleading conclusions. Furthermore, the quality of the included studies is critical; if the studies are of low methodological quality, merging their results could obscure true effects rather than explain them.

Protocol

A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.

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