Evidence map›Paper›PMID 30835135›Full record

SynthesisJournal of alternative and complementary medicine (New York, N.Y.)2019

Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.

Daniel Litrownik, Elizabeth Gilliam, Danielle Berkowitz, Gloria Y Yeh, Peter M Wayne

Open access · bronzeAbstract readSystematic Review
In one paragraph

Synthesis in Journal of alternative and complementary medicine (New York, N.Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 37% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. CommunityJournal of alternative and complementary medicine (New York, N.Y.) · 2021
    Article
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

5 authors at 2 institutions in 1 country.

Daniel Litrownik1 Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Elizabeth Gilliam1 Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Danielle Berkowitz1 Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Gloria Y Yeh1 Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Peter M Wayne2 Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Beth Israel Deaconess Medical Center · USHarvard University · US

Funding

Mentoring and Patient-Oriented Research in Mind-Body ExerciseK24AT009465 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI GLORIA Y YEH · 2017 to 2026
$1.3M
Mentoring and research in mind-body and integrative therapiesK24AT009282 · NCCIH · BRIGHAM AND WOMEN'S HOSPITAL · PI WAYNE, PETER MICHAEL · 2017 to 2021
$834k
NCCIH NIH HHS K24 AT009282NCCIH NIH HHS K24 AT009465
6 · The paper itself

Abstract

backgroundMind-body exercise interventions are typically multimodal, complex, and pluralistic, and few have been developed with the goal of therapeutically targeting a specific medical population. It is thus important that clinical trials evaluating mind-body interventions provide some justification for the use of the specific protocol being evaluated.

objectivesThis article reports the results of a systematic review of the quality of reporting of protocol rationale and content validity for using a specific t'ai chi protocol in a randomized controlled trial (RCT).

methodsElectronic literature searches were conducted using PubMed/MEDLINE, EBSCOhost, and the Cochrane Library from inception through June 2015. Search terms were Tai Chi, Taiji, Tai Chi Chuan; searches were limited to English-language RCTs. Inclusion and exclusion of trials were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors assessed the level of reporting with respect to t'ai chi protocol validation using a 5-point grading system based on whether (1) a specific protocol was mentioned, (2) rationale for the specific protocol was stated and supported, and (3) formal evaluation for content validity was conducted.

resultsThere was significant heterogeneity in the quality of reporting related to protocol rationale and content validity. A total of 171 publications were identified. Studies met between 0 and 4 validity criteria (of possible 5, more indicating better quality), with a mean of 2.52 (±SD 1.2) and median of 3. Twenty (12%) trials did not mention a specific t'ai chi protocol, 10 (6%) trials met 0 of 5 criteria, and 47 (31%) studies met 4 of 5 criteria. Formal validity assessments were employed in only one trial.

conclusionsThe poor quality of protocol rationale and content validity reporting limits our ability to accurately evaluate the evidence of t'ai chi as a therapeutic intervention. The development of formal guidelines for developing and reporting intervention validity for multimodal mind-body exercises like t'ai chi may improve the quality and interpretability of research.

Indexed as

Tai JiHumansRandomized Controlled Trials as Topiccontent validitymethodologymind–bodynonpharmacological interventionprotocol rationale

Identifiers

PMID30835135
PMCPMC6909733
OpenAlexW2919232898

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.