Evidence map›Paper›PMID 29284795›Full record

ReviewSpinal cord2018

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

Linda A T Jones, Anne Bryden, Tracey L Wheeler, Keith E Tansey, Kim D Anderson, Michael S Beattie, Andrew Blight, Armin Curt, Edelle Field-Fote, James D Guest and 15 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Spinal cord, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–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

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

25 authors.

Linda A T JonesCraig H. Neilsen Foundation, Encino, CA, USA. linda@chnfoundation.org.
Anne BrydenCase Western Reserve University, Cleveland, OH, USA.
Tracey L WheelerCraig H. Neilsen Foundation, Encino, CA, USA.
Keith E TanseyUniversity of Mississippi Medical Center, Jackson, MS, USA.
Kim D AndersonUniversity of Miami, Miami, FL, USA.
Michael S BeattieUniversity of California, San Francisco, CA, USA.
Andrew BlightAcorda Therapeutics, Ardsley, NY, USA.
Armin CurtUniversity Hospital Balgrist, Zurich, Switzerland.
Edelle Field-FoteShepherd Center, Atlanta, GA, USA.
James D GuestUniversity of Miami, Miami, FL, USA.
Jane HseihWings for Life, Salzburg, Austria.
Lyn B JakemanNational Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.
Sukhvinder Kalsi-RyanToronto Rehabilitation Institute, Toronto, ON, Canada.
Laura KrisaThomas Jefferson University, Philadelphia, PA, USA.
Daniel P LammertseCraig Hospital, Englewood, CO, USA.
Benjamin LeibyThomas Jefferson University, Philadelphia, PA, USA.
Ralph MarinoThomas Jefferson University, Philadelphia, PA, USA.
Jan M SchwabThe Ohio State University, Columbus, OH, USA.
Giorgio ScivolettoFoundation Saint Lucia, Rome, Italy.
David S TulskyUniversity of Delaware, Newark, DE, USA.
Ed WirthAsterias Biotherapeutics, Fremont, CA, USA.
José ZariffaToronto Rehabilitation Institute, Toronto, ON, Canada.
Naomi KleitmanCraig H. Neilsen Foundation, Encino, CA, USA.
Mary Jane MulcaheyThomas Jefferson University, Philadelphia, PA, USA.
John D SteevesUniversity of British Columbia, Vancouver, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designThis is a focused review article.

objectivesThis 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.

methodsThe methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review.

resultsCOAs 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.

conclusionsWith 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.

Indexed as

Clinical Trials as TopicHumansOutcome Assessment, Health CareSpinal Cord Injuries

Identifiers

PMID29284795
PMCPMC5951792

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.