SPIRIT - Revision history

Lawrence: /* Bibliography */

2025-06-04T13:32:48Z

Bibliography

← Older revision		Revision as of 13:32, 4 June 2025
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	== Bibliography ==		----
	# Chan AW, Tetzlaff JM~~, Altman DG, Laupacis A~~, Gøtzsche PC, ~~Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D~~. ~~[https~~:~~//pubmed~~.~~ncbi~~.~~nlm~~.~~nih~~.~~gov/23295957/~~ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. ~~Ann Intern Med~~. 2013 ~~Feb 5~~;158(3):~~200~~-7.
	# Chan A-W, ~~Boutron I~~, ~~Hopewell S~~, ~~Moher D~~, ~~Schulz KF~~, ~~Collins GS~~, ~~Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, 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, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hróbjartsson A. ~~[https://www~~.~~nature~~.~~com/articles/s41591-025-03668-w/ SPIRIT 2025 statement~~: ~~updated guideline for~~ protocols ~~of randomized trials]. Nature Medicine 2025~~.		=== Bibliography ===

			# Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. ''BMJ''. 2013;346:e7586.
			# Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. ''Annals of Internal Medicine''. 2013;158(3):200–207.
			# SPIRIT Group. SPIRIT 2013: Guidance for protocols of clinical trials. Available from: https://www.spirit-statement.org
			# Chan A-W, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. ''The Lancet''. 2014;383(9913):257–266. Discusses the role of protocol transparency and SPIRIT.
			# Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database — update and key issues. ''New England Journal of Medicine''. 2011;364(9):852–860. Highlights importance of detailed protocols like those guided by SPIRIT.

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	''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''		''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''

Lawrence: /* Bibliography */

2025-06-03T20:35:18Z

Bibliography

← Older revision		Revision as of 20:35, 3 June 2025
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	== Bibliography ==		== Bibliography ==
	# Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.		# Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.
			# Chan A-W, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, 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, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hróbjartsson A. [https://www.nature.com/articles/s41591-025-03668-w/ SPIRIT 2025 statement: updated guideline for protocols of randomized trials]. Nature Medicine 2025.

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	''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''		''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''

Lawrence: /* Bibliography */

2025-04-23T18:59:03Z

Bibliography

← Older revision		Revision as of 18:59, 23 April 2025
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	== Bibliography ==		== Bibliography ==
	# Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, # Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.		# Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.

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	''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''		''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''

Lawrence: /* Bibliography */

2025-04-23T18:58:36Z

Bibliography

← Older revision		Revision as of 18:58, 23 April 2025
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	== Bibliography ==		== Bibliography ==
	Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.		# Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, # Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.

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	''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''		''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''

Lawrence at 23:19, 7 April 2025

2025-04-07T23:19:40Z

← Older revision		Revision as of 23:19, 7 April 2025
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	# '''[[Trial outcomes\|Outcomes]]''' – Defined primary and secondary outcome measures and assessment methods.		# '''[[Trial outcomes\|Outcomes]]''' – Defined primary and secondary outcome measures and assessment methods.
	# '''[[Sample size\|Sample Size]] & Power Calculation''' – Justification and statistical assumptions.		# '''[[Sample size\|Sample Size]] & Power Calculation''' – Justification and statistical assumptions.
	# '''[[Randomization]] & [[Blinding]]''' – Sequence generation, allocation concealment, and blinding.		# '''[[Randomization]] & [[Blinding]]''' – Sequence generation, [[allocation concealment]], and blinding.
	# '''[[Data management plan (DMP)\|Data Collection & Management]]''' – Data acquisition, monitoring, and handling of missing data.		# '''[[Data management plan (DMP)\|Data Collection & Management]]''' – Data acquisition, monitoring, and handling of [[missing data]].
	# '''[[Ethics]] & Dissemination''' – Ethical approvals, informed consent, and dissemination plans.		# '''[[Ethics]] & Dissemination''' – Ethical approvals, [[informed consent]], and dissemination plans.

	== Benefits of Using SPIRIT ==		== Benefits of Using SPIRIT ==
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	== Bibliography ==		== Bibliography ==
	Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7~~. doi: 10.7326/0003-4819-158-3-201302050-00583. PMID: 23295957; PMCID: PMC5114123~~.		Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7.

	~~<nowiki>~~----~~</nowiki>~~		----

	~~<nowiki>~~''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''~~</nowiki>~~		''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''

Lawrence at 00:36, 4 April 2025

2025-04-04T00:36:16Z

← Older revision		Revision as of 00:36, 4 April 2025
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	# '''Administrative Information''' – Trial title, registration, protocol version, funding sources, and roles/responsibilities.		# '''Administrative Information''' – Trial title, registration, protocol version, funding sources, and roles/responsibilities.
	# '''Background & Rationale''' – Scientific justification, existing evidence, and knowledge gaps.		# '''Background & Rationale''' – Scientific justification, existing evidence, and knowledge gaps.
	# '''Objectives & Hypotheses''' – Clearly defined primary and secondary objectives and research questions.		# '''Objectives & [[Hypothesis\|Hypotheses]]''' – Clearly defined primary and secondary objectives and research questions.
	# '''Trial Design''' – Study type (e.g., RCT, crossover), allocation, and blinding strategies.		# '''[[Types of trials\|Trial Design]]''' – Study type (e.g., RCT, crossover), allocation, and blinding strategies.
	# '''Eligibility Criteria''' – Inclusion and exclusion criteria for participants.		# '''[[Trial participants\|Eligibility Criteria]]''' – Inclusion and exclusion criteria for participants.
	# '''Interventions''' – Detailed description of the intervention, dose, duration, administration, and comparator.		# '''[[Trial interventions\|Interventions]]''' – Detailed description of the intervention, dose, duration, administration, and comparator.
	# '''Outcomes''' – Defined primary and secondary outcome measures and assessment methods.		# '''[[Trial outcomes\|Outcomes]]''' – Defined primary and secondary outcome measures and assessment methods.
	# '''Sample Size & Power Calculation''' – Justification and statistical assumptions.		# '''[[Sample size\|Sample Size]] & Power Calculation''' – Justification and statistical assumptions.
	# '''Randomization & Blinding''' – Sequence generation, allocation concealment, and blinding.		# '''[[Randomization]] & [[Blinding]]''' – Sequence generation, allocation concealment, and blinding.
	# '''Data Collection & Management''' – Data acquisition, monitoring, and handling of missing data.		# '''[[Data management plan (DMP)\|Data Collection & Management]]''' – Data acquisition, monitoring, and handling of missing data.
	# '''Ethics & Dissemination''' – Ethical approvals, informed consent, and dissemination plans.		# '''[[Ethics]] & Dissemination''' – Ethical approvals, informed consent, and dissemination plans.

	== Benefits of Using SPIRIT ==		== Benefits of Using SPIRIT ==

Lawrence at 00:33, 4 April 2025

2025-04-04T00:33:13Z

← Older revision		Revision as of 00:33, 4 April 2025
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	* Facilitate ethical and regulatory review		* Facilitate ethical and regulatory review
	* Enhance reproducibility and scientific rigor		* Enhance reproducibility and scientific rigor

	~~SPIRIT applies to a wide range of interventional trials, including:~~
	* [[Randomized controlled trials (RCTs)]]
	* Non-randomized studies
	* Pragmatic trials

	It supports researchers, ethics committees, funding agencies, and regulatory bodies in evaluating the feasibility and scientific validity of trials.		It supports researchers, ethics committees, funding agencies, and regulatory bodies in evaluating the feasibility and scientific validity of trials.
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	See also:		'''See also:''' [[CONSORT]]; [https://www.spirit-statement.org Official SPIRIT website]
	* [[CONSORT]] ~~– For reporting completed trials~~		----
	* [https://www.spirit-statement.org Official SPIRIT website]
			== Bibliography ==
			Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. [https://pubmed.ncbi.nlm.nih.gov/23295957/ SPIRIT 2013 statement: defining standard protocol items for clinical trials]. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. PMID: 23295957; PMCID: PMC5114123.

			<nowiki>----</nowiki>

			<nowiki>''Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.''</nowiki>

Lawrence: Created page with "= SPIRIT= The '''Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)''' is a set of guidelines introduced in 2013 to improve the quality and completeness of clinical trial protocols. SPIRIT provides a structured framework for designing, reporting, and evaluating interventional study protocols. By promoting transparency and methodological rigor, SPIRIT enhances research credibility and supports regulatory compliance. == Purpose of SPIRIT == Inco..."

2025-03-26T05:06:15Z

Created page with "= SPIRIT= The '''Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)''' is a set of guidelines introduced in 2013 to improve the quality and completeness of clinical trial protocols. SPIRIT provides a structured framework for designing, reporting, and evaluating interventional study protocols. By promoting transparency and methodological rigor, SPIRIT enhances research credibility and supports regulatory compliance. == Purpose of SPIRIT == Inco..."

New page

= SPIRIT=

The '''Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)''' is a set of guidelines introduced in 2013 to improve the quality and completeness of clinical trial protocols. SPIRIT provides a structured framework for designing, reporting, and evaluating interventional study protocols. By promoting transparency and methodological rigor, SPIRIT enhances research credibility and supports regulatory compliance.

== Purpose of SPIRIT ==

Incomplete or poorly designed trial protocols can lead to methodological flaws, ethical concerns, and reduced reproducibility. SPIRIT addresses these issues by helping researchers develop comprehensive and standardized protocols that:
* Improve study execution and reporting
* Facilitate ethical and regulatory review
* Enhance reproducibility and scientific rigor

SPIRIT applies to a wide range of interventional trials, including:
* [[Randomized controlled trials (RCTs)]]
* Non-randomized studies
* Pragmatic trials

It supports researchers, ethics committees, funding agencies, and regulatory bodies in evaluating the feasibility and scientific validity of trials.

== Key Components of SPIRIT ==

SPIRIT consists of 33 essential items grouped into thematic domains. Key components include:

# '''Administrative Information''' – Trial title, registration, protocol version, funding sources, and roles/responsibilities.
# '''Background & Rationale''' – Scientific justification, existing evidence, and knowledge gaps.
# '''Objectives & Hypotheses''' – Clearly defined primary and secondary objectives and research questions.
# '''Trial Design''' – Study type (e.g., RCT, crossover), allocation, and blinding strategies.
# '''Eligibility Criteria''' – Inclusion and exclusion criteria for participants.
# '''Interventions''' – Detailed description of the intervention, dose, duration, administration, and comparator.
# '''Outcomes''' – Defined primary and secondary outcome measures and assessment methods.
# '''Sample Size & Power Calculation''' – Justification and statistical assumptions.
# '''Randomization & Blinding''' – Sequence generation, allocation concealment, and blinding.
# '''Data Collection & Management''' – Data acquisition, monitoring, and handling of missing data.
# '''Ethics & Dissemination''' – Ethical approvals, informed consent, and dissemination plans.

== Benefits of Using SPIRIT ==

* '''Enhances Trial Transparency''' – Improves reproducibility and scientific integrity.
* '''Improves Ethical & Regulatory Compliance''' – Standardized format supports ethical reviews.
* '''Facilitates Funding & Publication''' – Increases chances of grant approval and journal acceptance.
* '''Reduces Research Waste''' – Helps minimize protocol deviations and improves trial feasibility.
* '''Supports Evidence Synthesis''' – Standardized protocols improve comparability in systematic reviews and meta-analyses.

== Application of SPIRIT in Clinical Research ==

SPIRIT is widely used across disciplines including:
* Pharmaceutical research
* Medical device trials
* Behavioral and psychological interventions

Many academic journals and regulatory agencies encourage or require SPIRIT adherence to ensure trial quality.

== Challenges in Using SPIRIT ==

* '''Time-Intensive Development''' – Preparing a SPIRIT-compliant protocol requires effort and detailed documentation.
* '''Variable Implementation''' – Not all studies fully adhere to SPIRIT despite its endorsement.
* '''Lack of Enforcement''' – Some funders and journals do not enforce compliance, limiting uptake.

== Conclusion ==

The SPIRIT Statement is a cornerstone for high-quality trial protocols. It fosters rigor, transparency, and reproducibility across clinical trials. Broader adoption of SPIRIT can reduce research waste, improve ethical standards, and generate more reliable evidence to inform healthcare decisions.

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See also:
* [[CONSORT]] – For reporting completed trials
* [https://www.spirit-statement.org Official SPIRIT website]