Evidence map›Paper›PMID 27440100›Full record

ArticleRevista panamericana de salud publica = Pan American journal of public health2015

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

An-Wen Chan, Jennifer M Tetzlaff, Douglas G Altman, Andreas Laupacis, Peter C Gøtzsche, Karmela Krle A-Jerić, Asbjørn Hrobjartsson, Howard Mann, Kay Dickersin, Jesse A Berlin and 9 more

6 registry-linked trialsAbstract read
In one paragraph

Article in Revista panamericana de salud publica = Pan American journal of public health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 230 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
230citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03504813 nacompletednot on this mapstarted 2017, after this paper: background citation

Technologies for Participatory Medicine and Health Promotion in the Elderly Population

TypeinterventionalSponsorUniversidade da CoruñaRan2017 to 2019Enrolled57ConditionsAging, Age ProblemArmsPhysical activities program, Relaxation training, Training of the pelvic floor, Counseling about occupational performance
NCT04587388 unknown statusnot on this mapstarted 2019, after this paper: background citation

Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry

Typeobservational_patient_registrySponsorEuropean Hematology Association - Lymphoma GroupRan2019 to 2026Enrolled500ConditionsFollicular Lymphoma, Relapsed/Refractory Follicular Lymphoma
NCT04847297 not yet recruitingnot on this mapstarted 2021, after this paper: background citation

Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study

TypeobservationalSponsorUniversity of PecsRan2021 to 2026Enrolled353ConditionsPancreatic CancerArmsPreoperative drainage and pancreatoduodenectomy, Pancreatoduodenectomy
NCT06337370 nacompletednot on this mapstarted 2024, after this paper: background citation

Self-management Nursing Intervention for Women With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial

TypeinterventionalSponsorUniversidad Nacional de ColombiaRan2024 to 2025Enrolled44ConditionsArthritis, RheumatoidArmsChronic Disease Self Management Program, Conventional Intervention- Standard care
NCT06535269 narecruitingnot on this mapstarted 2022, after this paper: background citation

Prospective Randomized Study on Postoperative Pain in the Surgical Treatment of Hemorrhoids Through Conventional Hemorrhoidectomy With a Monopolar Electric Scalpel or Bipolar Energy With Caiman® (Aesculap®)

TypeinterventionalSponsorCorporacion Parc TauliRan2022 to 2025Enrolled27ConditionsHemorrhoid Pain, HemorrhoidectomyArmsMonopolar Hemorroidecotmy, Caiman Hemorroidectomy
NCT07654660 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy

TypeinterventionalSponsorUniversidad Europea de ValenciaRan2026 to 2028Enrolled120ConditionsChronic Refractory Plantar FasciopathyArmsMultimodal Conservative Intervention, Endoscopic Plantar Fascial Release
3 · Its place in the literature

Who cites it

230 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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170 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

An-Wen ChanWomen's College Research Institute Women's College Hospital.
Jennifer M TetzlaffOttawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute.
Douglas G AltmanCentre for Statistics in Medicine, Universidad de Oxford.
Andreas LaupacisKeenan Research Centre at the Li Ka Shing Knowledge, Institute of St. Michael's Hospital.
Peter C GøtzscheNordic Cochrane Centre, Rigshospitalet.
Karmela Krle A-JerićDepartment of Epidemiology and Community Medicine, University of Ottawa.
Asbjørn HrobjartssonNordic Cochrane Centre, Rigshospitalet.
Howard MannDivision of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, Estados Unidos.
Kay DickersinCenter for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, Estados Unidos.
Jesse A BerlinJanssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, Estados Unidos.
Caroline J DoreUK Medical Research Council Clinical Trials Unit, Reino Unido.
Wendy R ParulekarNCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Canadá
William S M SummerskillThe Lancet, Reino Unido.
Trish GrovesBMJ, Reino Unido.
Kenneth F SchulzTriangle Park, North Carolina, Estados Unidos.
Harold C SoxDartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Hanover, Estados Unidos.
Frank W RockholdTriangle Park, North Carolina, Estados Unidos.
Drummond RenniePR Lee Institute for Health Policy Studies, University of California, San Francisco, Estados Unidos.
David MoherClinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa.

Funding

CIHR 106068-1CIHR 78874-1
6 · The paper itself

Abstract

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Indexed as

Clinical Trials as TopicBiomedical ResearchChecklistResearch Personnel

Identifiers

PMID27440100
PMCPMC5114122

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.