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Record W2780957267 · doi:10.1038/s41393-017-0015-5

Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials

2017· review· en· W2780957267 on OpenAlexaff
Linda Jones, Anne M. Bryden, Tracey Wheeler, Keith E. Tansey, Kim D. Anderson, Michael S. Beattie, Andrew R. Blight, Armin Curt, Edelle C. Field‐Fote, James D. Guest, Jane Hseih, Lyn B. Jakeman, Sukhvinder Kalsi‐Ryan, Laura Krisa, Daniel P. Lammertse, Benjamin E. Leiby, Ralph J. Marino, Jan M. Schwab, Giorgio Scivoletto, David S. Tulsky, Wirth Ed, José Zariffa, Naomi Kleitman, M.J. Mulcahey, John D. Steeves

Bibliographic record

VenueSpinal Cord · 2017
Typereview
Languageen
FieldMedicine
TopicSpinal Cord Injury Research
Canadian institutionsUniversity of British ColumbiaToronto Rehabilitation InstituteUniversity of TorontoParkwood Institute
FundersCraig H. Neilsen Foundation
KeywordsMedicineClinical trialPhysical medicine and rehabilitationPhysical therapySpinal cord injuryInternational Classification of Functioning, Disability and HealthRehabilitationSpinal cordPathology

Abstract

fetched live from OpenAlex

STUDY DESIGN: This is a focused review article. OBJECTIVES: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified. METHODS: The methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review. RESULTS: COAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered. CONCLUSIONS: With an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA. SPONSORS: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.005
metaresearch head score (Gemma)0.007
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.975
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0050.007
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0030.000
Bibliometrics0.0010.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.793
GPT teacher head0.692
Teacher spread0.101 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designOther design
Domainnot available
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations44
Published2017
Admission routes1
Has abstractyes

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