Evidence map›Paper›PMID 38802802›Full record

ArticleBMC musculoskeletal disorders2024

How well do participants in clinical trials represent the U.S. population with chronic neck or back pain?

Brent D Leininger, Pamela Jo Johnson, Gert Bronfort, Karen M Kuntz, Eva Enns, James S Hodges, Roni Evans

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC musculoskeletal disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

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

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. 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

7 authors.

Brent D LeiningerIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA. lein0122@umn.edu.
Pamela Jo JohnsonDepartment of Public Health, North Dakota State University, 640R Aldevron Tower, 1455 14th Ave N, Fargo, ND, 58102, USA.
Gert BronfortIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Karen M KuntzDivision of Health Policy & Management School of Public Health, University of Minnesota, 420 Delaware St SE, MMC 729 Mayo, Minneapolis, MN, 55455, USA.
Eva EnnsDivision of Health Policy & Management School of Public Health, University of Minnesota, 420 Delaware St SE, MMC 729 Mayo, Minneapolis, MN, 55455, USA.
James S HodgesDivision of Biostatistics, School of Public Health, University of Minnesota, 2221 University Ave SE, Room 200 University Office Plaza, Minneapolis, MN, 55414, USA.
Roni EvansIntegrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.

Funding

Cost effectiveness of manipulation for spine pain using individual patient dataK01AT008965 · NCCIH · UNIVERSITY OF MINNESOTA · PI LEININGER, BRENT · 2016 to 2020
$559k
NCCIH NIH HHS K01 AT008965NCCIH NIH HHS K01AT008965
6 · The paper itself

Abstract

backgroundRandomized clinical trials (RCTs) are the gold standard for assessing treatment effectiveness; however, they have been criticized for generalizability issues such as how well trial participants represent those who receive the treatments in clinical practice. We assessed the representativeness of participants from eight RCTs for chronic spine pain in the U.S., which were used for an individual participant data meta-analysis on the cost-effectiveness of spinal manipulation for spine pain. In these clinical trials, spinal manipulation was performed by chiropractors.

methodsWe conducted a retrospective secondary analysis of RCT data to compare trial participants' socio-demographic characteristics, clinical features, and health outcomes to a representative sample of (a) U.S. adults with chronic spine pain and (b) U.S. adults with chronic spine pain receiving chiropractic care, using secondary data from the National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS). We assessed differences between trial and U.S. spine populations using independent t-tests for means and z-tests for proportions, accounting for the complex multi-stage survey design of the NHIS and MEPS.

resultsWe found the clinical trials had an under-representation of individuals from health disparity populations with lower percentages of racial and ethnic minority groups (Black/African American 7% lower, Hispanic 8% lower), less educated (No high school degree 19% lower, high school degree 11% lower), and unemployed adults (25% lower) with worse health outcomes (physical health scores 2.5 lower and mental health scores 5.3 lower using the SF-12/36) relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. are lower for individuals from health disparity populations, the trials also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor.

conclusionsHealth disparity populations are not well represented in spine pain clinical trials. Embracing key community-based approaches, which have shown promise for increasing participation of underserved communities, is needed.

Indexed as

Back PainChronic PainNeck PainRandomized Controlled Trials as TopicAdultAgedFemaleHumansMaleManipulation, ChiropracticManipulation, SpinalMiddle AgedPatient SelectionRetrospective StudiesTreatment OutcomeUnited StatesChronic painClinical trialsGeneralizabilityHealth disparities

Identifiers

PMID38802802
PMCPMC11129496

What OpenQuestion holds

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Registered trials

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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.