key: cord-0729964-sr4jv744
authors: Field-Fote; Edelle [Edee
title: Lessons From COVID-19 on the Stepwise Development of Interventions
date: 2020-05-22
journal: J Neurol Phys Ther
DOI: 10.1097/npt.0000000000000325
sha: fcb3773a15605c7c7f0a2484e69a552185341f63
doc_id: 729964
cord_uid: sr4jv744

nan

JNPT r Volume 00, 00 2020

The NIH Stage Model has high relevance for the development of rehabilitation interventions. While not shown in the figure, the stages are highly iterative and recursive, wherein evidence may show the need to return to prior stages before proceeding.

therapy treatments had a foundation in basic science studies of neuroplasticity and usedependent neural reorganization. 3, 4 Emerging, third-generation treatments build on secondgeneration treatments, adding various forms of neural stimulation to augment the electrical changes that underlie neural activation and thereby enhance neuroplastic effects of training. The progression of neurologic physical therapy approaches has lacked a stepwise approach. Progress has mostly been based on small studies that often lack conclusive evidence; issues of dose-response relationships have been largely unexplored.

The reasons underlying the differences in progression of pharmacologic/biologic interventions and rehabilitation interventions are many and varied. Studies of physical therapeutic interventions require large commitments of time from both participants and study personnel. Needless to say, the deliverables from these studies are not of the type that attract the interest of industry sponsors. However, the cadre of neurologic physical therapists who have gone on to acquire research training has grown steadily, as has our competitiveness in the acquisition of federal grant funding.

Leaving aside the language of clinical trial phasing that is used in the development of pharmacologic/biologic interventions, I believe we have a valuable opportunity to learn from our investigator colleagues in the behavioral sciences, for whom the National Institutes of Health (NIH) Stage Model serves as their framework for intervention development. 5 The NIH Stage Model "is an iterative, recursive, multidirectional model of behavioral intervention development" with 6 stages (see Figure) . Beginning with basic mechanistic studies (Stage 0) and progressing next to intervention refinement (Stage I; which may include dose-response assessment). The model emphasizes that the development of an intervention has been accomplished only when it can be implemented in a way that maximally meets the needs of the group for which it is intended (Stage V).

The NIH Stage Model offers a common language for intervention development research. It allows conceptual questions to be asked about where an intervention falls in the development cycle and whether the research has appropriately addressed each of the important milestones in that development. With this common language, stakeholders, clinicians, investigators, reviewers, and funding agencies can have meaningful conversations about the appropriate next steps that are needed before an intervention is ready to be applied in the clinical setting. Abiding by this model also ensures the research evidence exists to justify reimbursement when that time comes. Our patients and profession will surely benefit if we join with our behavioral research colleagues and embrace the NIH Stage Model as we pursue the development of neurologic physical therapy interventions.

An overview of history, evolution, and manufacturing of various generations of vaccines

Use-dependent alterations of movement representations in primary motor cortex of adult squirrel monkeys

Recovery of locomotion after chronic spinalization in the adult cat

National Institutes on Aging. The NIH Stage Model for behavioral intervention development