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Floor and ceiling effects in the EORTC QLQ‐C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer

Cancer, 2022-02, Vol.128 (4), p.808-818

2022

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Reply to “Another look at floor and ceiling effects in the EORTC QLQ‐C30 Physical Functioning subscale and possible solutions”

Cancer, 2022-06, Vol.128 (12), p.2386-2387

2022

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FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer

Clinical cancer research, 2020-08, Vol.26 (16), p.4180-4185

2020

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Epidemiology of Syncope/Collapse in Younger and Older Western Patient Populations

Progress in cardiovascular diseases, 2013, Vol.55 (4), p.357-363

2013

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Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials

The lancet oncology, 2022-05, Vol.23 (5), p.e229-e234

2022

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The opportunity for greater patient and public involvement and engagement in drug development and regulation

Nature reviews. Drug discovery, 2023-05, Vol.22 (5), p.337-338

2023

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Negative perceptions of aging and decline in walking speed: a self-fulfilling prophecy

PloS one, 2015-04, Vol.10 (4), p.e0123260-e0123260

2015

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Falls, non-accidental falls and syncope in community-dwelling adults aged 50 years and older: Implications for cardiovascular assessment

PloS one, 2017-07, Vol.12 (7), p.e0180997-e0180997

2017

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Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma

Quality of life research, 2023-08, Vol.32 (8), p.2281-2292

2023

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Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials

JNCI : Journal of the National Cancer Institute, 2021-05, Vol.113 (5), p.507-508

2021

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FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease

Quality of life research, 2020-07, Vol.29 (7), p.1903-1911

2020

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Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

Clinical trials (London, England), 2022-06, Vol.19 (3), p.267-273

2022

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Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions

Clinical trials (London, England), 2019-06, Vol.16 (3), p.322-326

2019

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Negative Perceptions of Aging Predict Longitudinal Decline in Cognitive Function

Psychology and aging, 2016-02, Vol.31 (1), p.71-81

2016

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Patient Report on the Impact of Coronavirus Disease 2019 and Living With Lung Cancer

JTO clinical and research reports, 2023-09, Vol.4 (9), p.100549-100549, Article 100549

2023

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Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

JTO clinical and research reports, 2023-10, Vol.4 (10), p.100575-100575, Article 100575

2023

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FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1

Clinical cancer research, 2020-05, Vol.26 (10), p.2284-2289

2020

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Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007–2017

JNCI : Journal of the National Cancer Institute, 2019-05, Vol.111 (5), p.459-464

2019

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Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective

JNCI : Journal of the National Cancer Institute, 2022-01, Vol.114 (1), p.12-19

2022

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Using structural equation modeling to detect response shift in performance and health-related quality of life scores of multiple sclerosis patients

Quality of life research, 2011-12, Vol.20 (10), p.1527-1541

2011

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US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017

The lancet oncology, 2019-10, Vol.20 (10), p.e582-e589

2019

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FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer

Clinical cancer research, 2019-05, Vol.25 (10), p.2949-2955

2019

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Best Practice Recommendations for Electronic Patient-Reported Outcome Dataset Structure and Standardization to Support Drug Development

Value in health, 2023-08, Vol.26 (8), p.1242-1248

2023

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Development of the brief ageing perceptions questionnaire (B-APQ): a confirmatory factor analysis approach to item reduction

BMC geriatrics, 2014-04, Vol.14 (1), p.44-44, Article 44

2014

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Floor and ceiling effects in the EORTC QLQ‐C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer

Reply to “Another look at floor and ceiling effects in the EORTC QLQ‐C30 Physical Functioning subscale and possible solutions”

FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer

Epidemiology of Syncope/Collapse in Younger and Older Western Patient Populations

Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials

The opportunity for greater patient and public involvement and engagement in drug development and regulation

Negative perceptions of aging and decline in walking speed: a self-fulfilling prophecy

Falls, non-accidental falls and syncope in community-dwelling adults aged 50 years and older: Implications for cardiovascular assessment

Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma

Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials

FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions

Negative Perceptions of Aging Predict Longitudinal Decline in Cognitive Function

Patient Report on the Impact of Coronavirus Disease 2019 and Living With Lung Cancer

Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1

Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007–2017

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective

Using structural equation modeling to detect response shift in performance and health-related quality of life scores of multiple sclerosis patients

US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017

FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer

Best Practice Recommendations for Electronic Patient-Reported Outcome Dataset Structure and Standardization to Support Drug Development

Development of the brief ageing perceptions questionnaire (B-APQ): a confirmatory factor analysis approach to item reduction

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