Unfounded Claims of Improved Functional Outcomes Attributed to ...

A recent study by Mendell et al. in Molecular Therapy claims to have demonstrated clinical and biomarker efficacy for inclusion body myositis ( ...

Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in Inclusion Body Myositis · Author · Affiliation.

Unfounded Claims of Improved Functional Outcomes Attributed to ...

The frequency of falls in this trial was 33% of the patients, and, without data indicating this was not excessive, the publication's conclusion that follistatin ...

Unfounded Claims of Improved Functional Outcomes Attributed to ...

1 in Mo- lecular Therapy claims to have demonstrated clinical and biomarker efficacy for inclusion body myositis (IBM) from follistatin gene therapy. Although ...

Bibliographic database on neuromuscular diseases - Myobase

Title: Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in Inclusion Body Myositis.

(PDF) Reply to Letter to the Editor submitted by Steven Greenberg ...

Reply to Letter to the Editor submitted by Steven Greenberg: “Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in ...

Unfounded Claims of Improved Functional Outcomes Attributed to ...

Mendell, J.R. (2017). Follistatin Gene Transfer to Patients with Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis. https://clinicaltrials.gov/ct2/ ...

Unfounded Claims of Improved Functional Outcomes Attributed to ...

Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in Inclusion Body Myositis (English). 1 reference.

Medline ® Abstracts for References 28,54 of 'Management of ...

... Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in Inclusion Body Myositis. AU: Greenberg SA; SO: Mol Ther. 2017;25(10): ...

Unfounded Claims of Improved Functional Outcomes Attributed to ...

Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in Inclusion Body Myositis. Greenberg, S.A.. Molecular Therapy: the ...

Medline ® Abstracts for References 54,55 of 'Management of ...

Unfounded Claims of Improved Functional Outcomes Attributed to Follistatin Gene Therapy in Inclusion Body Myositis. AU: Greenberg SA; SO: Mol Ther. 2017;25(10): ...

Guidance for Industry:Patient-Reported Outcome Measures - FDA

improvement of the symptoms and would not support a general claim related to improvement in a patient's ability to function or the patient's psychological state ...

The Regulation of Patient‐Reported Outcome Claims: Need for a ...

We argue that PRO claims often represent logical extrapolations of clinical effects. Even if PRO claims add new information that would not be anticipated, the ...

Change in Psychosocial Distress Associated With Pain and ... - jospt

... improved pain and functional outcomes at discharge from physical therapy services. Risk-adjusted multivariable modeling suggested that increased or stable ...

Relation Between Payer Source and Functional Outcomes, Visits ...

Request PDF | Relation Between Payer Source and Functional Outcomes, Visits and Treatment Duration in Patients with Lumbar Dysfunction | Background: The ...

Functional Outcomes Improvement - Care Practice Application

assistance due to medical condition or cognitive impairments ... • 51% of drug claims for this group were erroneous, not supported by ...

The Regulation of Patient-Reported Outcome Claims - Value in Health

The FDA interpreted these statements as unsub- stantial claims for improved functional status and productivity. ... expect an increased number of Type I errors ( ...

2635 Inpatient Rehabilitation Facility (IRF) Functional Outcome ...

strengthen incentives for quality improvement related to patient function. ... therapy tended to have improved functional outcomes, with greater improvement ...

Factors to Consider When Making Benefit-Risk Determinations in ...

significantly improved functional outcomes in comparison to the current standard of care. ... ☐ AEs or outcomes related to the use of the ...

The importance of functional impairment to mental health outcomes

As a result, functional outcomes might offer depression researchers more critical feedback and better guidance when studying depression treatment outcomes.