Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Updated Statistical Analysis Plan for this Embedded Pragmatic, Cluster Randomized

Abstract

The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) pragmatic, embedded, cluster-randomized trial is ongoing with enrollment starting in February 2020 and projected to end in first quarter of 2024. The 3-month follow up rate of primary outcome data collected as part of an AIM-Back clinical follow-up visit in the electronic health record has been lower than anticipated. At the recommendation of AIM-Back monitoring partners an updated statistical analysis plan was generated. The updated analysis plan allows for use of survey data to augment the follow up rate for the primary outcomes collected in the electronic health record. This updated statistical analysis plan was created and approved prior to completing enrollment and described in this paper.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Protocols

https://pubmed.ncbi.nlm.nih.gov/33313728/

Funding Statement

National Institutes of Health/National Center for Complementary and Integrative Health by UG3/UH3 grant AR009790

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Boards of Duke University and Durham VA Medical center gave ethical approval for this work

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

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