ArticleTherapeutic innovation & regulatory science2019
Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations.
Article in Therapeutic innovation & regulatory science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A Call for Drug Therapies for the Treatment of Social Behavior Disorders in Dementia: Systematic Review of Evidence and State of the Art.International journal of molecular sciences · 2022Pooled it
- Developing a core outcome set for traumatic brachial plexus injuries: a systematic review of outcomes.BMJ open · 2021Pooled it
- The patient reported intraocular lens questionnaire (PR-ILQ): content validity, psychometric performance, and use in a regulated clinical trial to evaluate safety and effectiveness outcomes.Journal of patient-reported outcomes · 2025Trial
- Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.Aesthetic surgery journal · 2023Trial
- Measuring Hunger Severity in Rare MC4R Pathway Diseases: Development and Psychometric Evaluation of the Most Hunger Item.Advances in therapy · 2026Article
- Test-Retest Reliability of a Performance-Based Test Battery in Patients with Fibromyalgia According to Socio-Occupational Status.Medical sciences (Basel, Switzerland) · 2026Article
- Performance outcomes of the PEDI-CAT for assessing functional ability in the population with leukodystrophy.Developmental medicine and child neurology · 2026Article
- Pilot Study: Repeated Utenpanium (RZL-012) Treatment for Submental Fat Reduction.Plastic and reconstructive surgery. Global open · 2026Article
- Do cognitive tests capture symptoms that matter to people with Huntington's disease?Scientific reports · 2025Article
- Article
- Evaluating therapeutic effects of exoskeletons and FES in SCI: integrative review of the literature.Spinal cord · 2025Review
- Excellent test-retest reliability of perturbation-evoked cortical responses supports feasibility of the balance N1 as a clinical biomarker.Journal of neurophysiology · 2025Article
- Using Smartphone Sensors for Ataxia Trials: Consensus Guidance by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers.Cerebellum (London, England) · 2024Review
- Qualitative interviews of patients with COPD and muscle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments.Journal of patient-reported outcomes · 2024Article
- Validity of a Smartphone App to Objectively Monitor Performance Outcomes in Degenerative Cervical Myelopathy: Preliminary Findings From a Longitudinal Observational Study.JMIR neurotechnology · 2024Article
- Assessing the Assisted Six-Minute Cycling Test as a Measure of Endurance in Non-Ambulatory Patients with Spinal Muscular Atrophy (SMA).Journal of clinical medicine · 2023Article
- Cognitive performance outcomes: considerations for drug development.Journal of patient-reported outcomes · 2023Article
- Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior.JCO clinical cancer informatics · 2023Review
- From Meaningful Outcomes to Meaningful Change Thresholds: A Path to Progress for Establishing Digital Endpoints.Therapeutic innovation & regulatory science · 2023Article
- Use of experimental medicine approaches for the development of novel psychiatric treatments based on orexin receptor modulation.Neuroscience and biobehavioral reviews · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
The use of performance outcome (PerfO) assessments to measure cognitive or physical function in drug trials presents several challenges for both sponsors and regulators, owing in part to a relative lack of scientific guidance on their development, implementation, and interpretation. In December 2016, the Duke-Margolis Center for Health Policy convened a 2-day workshop to explore the evidentiary, methodologic, and operational challenges associated with PerfO measures, and to identify potential paths to addressing these challenges. This paper presents both a summary of the discussion as well as additional input from a working group of experts from FDA, industry, academia, and public-private consortia. It is intended to advance the discussion around the development and use of PerfO measures to assess patient functioning in clinical trials intended to support registration of new treatments, and to highlight the key gaps in knowledge where additional research, collaboration, and discussion are needed.
Indexed as
Identifiers
What OpenQuestion holds
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.