Evidence map›Paper›PMID 36823645›Full record

Trial reportTrials2023

Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME).

Julie M Fritz, Tom Greene, Gerard P Brennan, Kate Minick, Elizabeth Lane, Stephen T Wegener, Richard L Skolasky

Registry-linked trialOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03859713 (Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 13% 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.

NCT03859713 nacompletednot on this map

Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain

TypeinterventionalSponsorUniversity of UtahRan2019 to 2024Enrolled749ConditionsLow Back Pain, Chronic PainArmsPhysical Therapy, Cognitive Behavioral Therapy, Mindfulness, Phase I Treatment, Phase II Switching
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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 at 3 institutions in 1 country.

Julie M FritzDepartment of Physical Therapy & Athletic Training, University of Utah, 383 Colorow Drive, Room 391, Salt Lake City, UT, 84108, USA. julie.fritz@utah.edu.ORCID http://orcid.org/0000-0002-3599-1057
Tom GreeneDepartment of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.
Gerard P BrennanRehabilitation Services, Intermountain Healthcare, Salt Lake City, UT, USA.
Kate MinickRehabilitation Services, Intermountain Healthcare, Salt Lake City, UT, USA.
Elizabeth LaneDepartment of Physical Therapy & Athletic Training, University of Utah, 383 Colorow Drive, Room 391, Salt Lake City, UT, 84108, USA.
Stephen T WegenerDepartment of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD, USA.
Richard L SkolaskyDepartment of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD, USA.
University of Utah · USIntermountain Healthcare · USJohns Hopkins University · US

Funding

Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS UL1 TR002538Patient-Centered Outcomes Research Institute OTS-LBP-2017C1-6486
6 · The paper itself

Abstract

backgroundThe OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered.

methodsThe FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants' motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments.

resultsModifications were developed with input from the trial's patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions' core functions. Modifications were approved by the study funder and the trial steering committee.

conclusionsFull and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial's eventual results and considering future implementation efforts.

trial registrationClinicalTrials.gov NCT03859713. Registered on March 1, 2019.

Indexed as

COVID-19Low Back PainAdultComparative Effectiveness ResearchEvidence-Based MedicineHumansPandemicsComparative effectiveness researchFidelityImplementationLow back painModificationPragmatic clinical trial

Identifiers

PMID36823645
PMCPMC9947905
OpenAlexW4321616010

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.