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1
Dialectical behavior therapy skills utilization: a three-month follow-up study on clinical outcomes
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2
A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia ; Frontiers in Neurology
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3
Semantic feature effects on SFA treatment outcomes (Evans et al., 2020)
Alyssa M. Autenreith (8958787); William S. Evans (4717620); William D. Hula (4717608). - 2020
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4
Linguistic Predictors of Anomia Treatment Outcomes
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5
Characteristics and Treatment Outcomes of Benign Paroxysmal Positional Vertigo in a Cohort of Veterans
In: ETSU Faculty Works (2017)
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6
Gesture production as a predictor of treatment outcomes for children with autism in early intensive behavioral intervention
Harrison, Bryan Robert (1982 - ); Bennetto, Loisa. - : University of Rochester, 2017
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7
Interventions for comorbid problem gambling and psychiatric disorders : advancing a developing field of research
Dowling, NA; Merkouris, SS; Lorains, FK. - : Elsevier, 2016
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8
Toward validation of an acoustic index of dysphonia severity ...
Peterson, Elizabeth Anne. - : University of Utah, 2012
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9
Toward validation of an acoustic index of dysphonia severity ; Master of Science
Peterson, Elizabeth Anne. - : University of Utah, 2012
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10
Statistical, Practical, Clinical, and Personal Significance: Definitions and Applications in Speech-Language Pathology
In: Faculty Publications (2011)
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11
Patient-Evaluated Dentistry: Development and Validation of a Patient Satisfaction Questionnaire for Fixed Prosthodontic Treatment
Layton, Danielle; Walton, Terry. - : QUINTESSENCE PUBLISHING CO INC, 2011
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12
A Mixed Methods Approach to Evaluating Treatment Outcomes for an Eclectic Approach to Intensive Stuttering Therapy
In: http://rave.ohiolink.edu/etdc/view?acc_num=bgsu1275501979 (2010)
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13
Home-based speech treatment for Parkinson's disease delivered remotely: a case report
Constantinescu, Gabriella A.; Theodoros, Deborah G.; Russell, Trevor G.. - : Royal Society of Medicine Press Ltd., 2010
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14
Dosage and Distribution in Morphosyntax Intervention: Current Evidence and Future Needs
In: ETSU Faculty Works (2009)
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15
Treatment of aphasia : maximizing outcomes
White, Julia R.. - : Northern Illinois University, 2008
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16
Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.
Bradley, Clare. - : Unkown Publisher, 2006
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17
Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.
Bradley, Clare. - 2006
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18
Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.
Bradley, Clare. - : Unkown Publisher, 2006
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19
Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.
Bradley, Clare. - : Unkown Publisher, 2006
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20
Comments on 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support labeling Claims'.
Bradley, Clare. - : Unkown Publisher, 2006
Abstract: I have a particular interest in the FDA's guidance on patient-reported outcome (PRO measures as I specialize in the design, development and use of such measures and license them to pharmaceutical companies, research organizations, academics and clinicians for use in clinical trials, other research and routine clinical practice. My measures include: the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in it's status (DTSQs) and change (DTSQc) forms and related measures for other conditions including the HIVTSQ, RTSQ, RetTSQ, GHerpTSQ, ThyTSQ, and the newly designed DTSQ-Teen and DTSQ-Parent. The DTSQs and c are fully linguistically validated in more than 60 language versions. - the Well-being Questionnaire (e.g. W-BQ12) generic measure of well-being is psychometrically validated for a range of populations including those who have diabetes (type 1 and type 2) macular disease and growth hormone deficiency and fully linguistically validated in 25 language versions. - the ADDQoL measure of the impact of diabetes on quality o life with related measures for other conditions including RDQoL, RETQol, MacDQoL, HDQoL, ARHDQoL, ThyDQoL, ADDQoL Teen and recently designed ADDToL Jnr (for 5-8 year olds) and ADDQoL Jnr+ for (9-12 year olds). The ADDQoL, MacQoL and RetQoL are linguistically validated in 16-25 language versions. I welcome the FDA guidance as a much needed source of information about the standards required on PRO design, linguistic validation, psychometric validation and use and recognise that the guidance may be very useful in encouraging good practice. I comment on issues in the order in which they first appear in the guidance and thereafter identify omissions that I ask be considered for inclusion.
Keyword: Diabetes Treatment Satisfaction Questionnaire. Well-being questionnaire; Patient Reported outcomes; Quality of life
URL: https://repository.royalholloway.ac.uk/items/d4c4a3e3-6af4-6637-147f-e5247fce0115/3/
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