N K Leidy
Affiliation: MEDTAP International
- Recommendations for evaluating the validity of quality of life claims for labeling and promotionN K Leidy
Center for Health Outcomes Research, MEDTAP International, Bethesda, MD 20814, USA
Value Health 2:113-27. 1999..Examples are provided to highlight important points. The paper concludes with a brief discussion of future trends in HRQL outcomes evaluation...
- The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretationNancy Kline Leidy
Center for Health Outcomes Research, MEDTAP International Inc, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA
Chest 124:2182-91. 2003..A patient report of respiratory symptoms in COPD is essential to successfully monitoring disease, adjusting treatment, and evaluating outcomes...
- The impact of severe respiratory syncytial virus on the child, caregiver, and family during hospitalization and recoveryNancy Kline Leidy
MEDTAP Institute at UBC, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA
Pediatrics 115:1536-46. 2005..To quantify the magnitude of child, caregiver, and family distress associated with hospitalization for severe respiratory syncytial virus (RSV) and the posthospitalization recovery period...
- Seizure frequency and the health-related quality of life of adults with epilepsyN K Leidy
Center for Health Outcomes Research, MEDTAP International Inc, Bethesda, MD 20814, USA
Neurology 53:162-6. 1999....
- Evaluating Health-related quality-of-life outcomes in patients with congestive heart failure. A review of recent randomised controlled trialsN K Leidy
Center for Health Outcomes Research, MEDTAP International, Inc, Bethesda, Maryland, USA
Pharmacoeconomics 15:19-46. 1999..Preference-based or utility assessment, ethnic group differences in treatment effectiveness, caregiver burden and cost effectiveness are understudied outcomes in CHF research...
- Bridging the gap: using triangulation methodology to estimate minimal clinically important differences (MCIDs)Nancy Kline Leidy
MEDTAP International, 7101 Wisconsin Avenue, Suite 600, Bethesda, Maryland 20814, USA
COPD 2:157-65. 2005....
- Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum ScaleN K Leidy
Center for Health Outcomes Research, MEDTAP International, Bethesda, MD 20814, USA
Respir Med 97:S59-70. 2003..0001). Results suggest that the BCSS is a reliable, valid, and responsive patient-reported outcome measure of symptom severity in patients with COPD...
- Integrating patient preferences into health outcomes assessment: the multiattribute Asthma Symptom Utility IndexD A Revicki
MEDTAP International, Inc, Bethesda, MD 20814, USA
Chest 114:998-1007. 1998..To develop and evaluate a brief, easy-to-administer symptom assessment scale for use as a preference-based outcome measure in clinical trials and cost-effectiveness studies in asthma...
- Development and preliminary validation of the multiattribute Rhinitis Symptom Utility IndexD A Revicki
Center for Health Outcome Research, MEDTAP International, Inc, Bethesda, MD 20814, USA
Qual Life Res 7:693-702. 1998..The modest reproducibility reflects the day to day variability of rhinitis. The RSUI may be a useful patient outcome for clinical trials and for cost-effectiveness studies comparing medical treatments for rhinitis...
- Measuring respiratory symptoms in clinical trials of COPD: reliability and validity of a daily diaryN K Leidy
Evidera, Bethesda, Maryland, USA
Thorax 69:443-9. 2014..Although respiratory symptoms are characteristic features of COPD, there is no standardised method for quantifying their severity in stable disease...
- Recommendations on health-related quality of life research to support labeling and promotional claims in the United StatesD A Revicki
MEDTAP International, Bethesda, Maryland, USA
Qual Life Res 9:887-900. 2000....
- The impact of asthma on health-related quality of lifeJ K Schmier
Center for Health Outcomes Research, MEDTAP International Inc, Bethesda, Maryland 20814, USA
J Asthma 35:585-97. 1998....
- When is the dyspnea worth it? Understanding functional performance in people with alpha-1 antitrypsin deficiencyA Knebel
National Institutes of Health, Clinical Center Nursing Department, Bethesda, MD 20892 1506, USA
Image J Nurs Sch 30:339-43. 1998..A severe deficiency of AAT affects 1:3,500 to 1:1,670 Americans who can develop debilitating emphysema in the third to fifth decades of life...
- A comparative trial of paper-and-pencil versus computer administration of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaireL Kleinman
Center for Health Outcomes Research, MEDTAP International Inc, Bethesda, Maryland, USA
Med Care 39:181-9. 2001..Novel methods of instrument administration must be assessed for score equivalence in addition to consistency in reliability and validity...
- Psychometric properties of the VSQLQ in black patients with mild hypertension. Vital Signs Quality of Life QuestionnaireN K Leidy
Center for Health Outcomes Research, MEDTAP Intl, Inc, Bethesda, MD 20814, USA
J Natl Med Assoc 92:550-7. 2000..05). Results support the reliability and validity of VSQLQ administered via personal interview to black patients with mild systemic hypertension...
- Health-related quality of life in patients receiving reduced-intensity conditioning allogeneic hematopoietic stem cell transplantationM F Bevans
Department of Nursing, National Institutes of Health, Bethesda, MD 20892, USA
Bone Marrow Transplant 38:101-9. 2006..Two-year survivors report a return to baseline or better in HRQL by day 100, with the exception of physical health in MT patients...
- Assessment of health-related quality of life in children: a review of conceptual, methodological, and regulatory issuesLouis S Matza
MEDTAP International Inc, Bethesda, MD 20814, USA
Value Health 7:79-92. 2004..a recommendation for additional research on the HRQL impact of childhood psychiatric disorders. It is advocated that assessment of HRQL among children should be conducted regularly as an integral part of drug development...
- Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001Catherine Acquadro
MAPI Research Institute, Lyon, France
Value Health 6:522-31. 2003..The working group therefore became known as the PRO Harmonization Group...
- Evolving concepts in the measurement of treatment effectsNancy Kline Leidy
Health Care Analytics Group, United BioSource Corporation, Bethesda, MD 20814, USA
Proc Am Thorac Soc 3:212-7. 2006..Each of these areas offers interesting challenges and opportunities for further development and research...
- Onset of effect of budesonide and formoterol administered via one pressurized metered-dose inhaler in patients with asthma previously treated with inhaled corticosteroidsHarold Kaiser
Clinical Research Institute, Minneapolis, Minnesota, USA
Ann Allergy Asthma Immunol 101:295-303. 2008..Onset of bronchodilation of budesonide/formoterol in one pressurized metered-dose inhaler (pMDI) has not been evaluated in asthma...
- Measuring functional performance in patients with COPD: a discussion of patient-reported outcome measuresDonald E Stull
Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA
Curr Med Res Opin 23:2655-65. 2007....
- Subjective measurement of activity in chronic obstructive pulmonary diseaseNancy Kline Leidy
United BioSource Corporation, Bethesda, Maryland 20814, USA
COPD 4:243-9. 2007..Examples of measures designed to capture these concepts are provided. The paper concludes with recommendations for evaluating activity-related outcomes in patients with chronic obstructive pulmonary disease...
- Reduction in oral corticosteroid use with mometasone furoate dry powder inhaler improves health-related quality of life in patients with severe persistent asthmaJordana Schmier
MEDTAP International Inc, Bethesda, Maryland 20814, USA
J Asthma 40:383-93. 2003..These improvements were maintained during the 3-month period of the OLE in which HRQL was evaluated...
- Interpreting results from clinical trials: understanding minimal clinically important differences in COPD outcomesBarry Make
COPD 2:1-5. 2005
- Integrating the patient's perspective into device evaluation trialsNancy Kline Leidy
Center for Health Outcomes Research at United BioSource Corporation, Bethesda, MD 20814, USA
Value Health 9:394-401. 2006..This article discusses the potential value and difficulties in measuring PROs in device studies...
- The New York Heart Association Classes and functional status: what are we really measuring?Claiborne Miller-Davis
Mark O Hatfield Clinical Research Center, National Institutes of Health, Bethesda, Maryland 20892, USA
Heart Lung 35:217-24. 2006..This premise is illustrated quantitatively through secondary analysis of data from 22 patients with ischemic heart disease and left ventricular dysfunction...
- The health-related quality of life effects of once-daily cetirizine HCl syrup in children with seasonal allergic rhinitisSherwin A Gillman
CHOC Pediatric Subspecialty Faculty, Division of Allergy and Immunology, Children s Hospital of Orange County, Orange, CA 92868, USA
Clin Pediatr (Phila) 41:687-96. 2002..This 4-week open label study is among the first to evaluate the effect of antihistamine treatment on HRQL outcomes in children...