-
1
-
-
33746261692
-
-
US Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health
-
US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims 〈http://purl.access.gpo.gov/GPO/LPS113413〉 (2009).
-
(2009)
Guidance for Industry Patient-reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
-
-
-
2
-
-
9944234591
-
Measuring treatment impact: A review of patient-reported outcomes and other efficacy endpoints in approved product labels
-
DOI 10.1016/j.cct.2004.09.003, PII S0197245604000911
-
Willke, R.J., Burke, L.B. & Erickson, P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Control. Clin. Trials 25, 535-552 (2004). (Pubitemid 39592859)
-
(2004)
Controlled Clinical Trials
, vol.25
, Issue.6
, pp. 535-552
-
-
Willke, R.J.1
Burke, L.B.2
Erickson, P.3
-
3
-
-
36849010940
-
Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks
-
DOI 10.1200/JCO.2007.12.7670
-
Sloan, J.A. et al.; National Cancer Institute. Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. J. Clin. Oncol. 25, 5070-5077 (2007). (Pubitemid 350232285)
-
(2007)
Journal of Clinical Oncology
, vol.25
, Issue.32
, pp. 5070-5077
-
-
Sloan, J.A.1
Berk, L.2
Roscoe, J.3
Fisch, M.J.4
Shaw, E.G.5
Wyatt, G.6
Morrow, G.R.7
Dueck, A.C.8
-
4
-
-
0036112505
-
Assessing health status and quality-of-life instruments: Attributes and review criteria
-
DOI 10.1023/A:1015291021312
-
Lohr, K.N. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual. Life Res. 11, 193-205 (2002). (Pubitemid 34553501)
-
(2002)
Quality of Life Research
, vol.11
, Issue.3
, pp. 193-205
-
-
Lohr, K.N.1
-
5
-
-
85047670095
-
Conceptual models for health education research and practice
-
Earp, J.A. & Ennett, S.T. Conceptual models for health education research and practice. Health Educ. Res. 6, 163-171 (1991).
-
(1991)
Health Educ. Res.
, vol.6
, pp. 163-171
-
-
Earp, J.A.1
Ennett, S.T.2
-
6
-
-
67651211948
-
A conceptual model of the experience of dyspnea and functional limitations in chronic obstructive pulmonary disease
-
Victorson, D.E., Anton, S., Hamilton, A., Yount, S. & Cella, D. A conceptual model of the experience of dyspnea and functional limitations in chronic obstructive pulmonary disease. Value Health 12, 1018-1025 (2009).
-
(2009)
Value Health
, vol.12
, pp. 1018-1025
-
-
Victorson, D.E.1
Anton, S.2
Hamilton, A.3
Yount, S.4
Cella, D.5
-
7
-
-
70349959880
-
Qualitative research and content validity: Developing best practices based on science and experience
-
Brod, M., Tesler, L.E. & Christensen, T.L. Qualitative research and content validity: developing best practices based on science and experience. Qual. Life Res. 18, 1263-1278 (2009).
-
(2009)
Qual. Life Res.
, vol.18
, pp. 1263-1278
-
-
Brod, M.1
Tesler, L.E.2
Christensen, T.L.3
-
8
-
-
69249212278
-
Building PROMIS item banks: Librarians as co-investigators
-
Klem, M., Saghafi, E., Abromitis, R., Stover, A., Dew, M.A. & Pilkonis, P. Building PROMIS item banks: librarians as co-investigators. Qual. Life Res. 18, 881-888 (2009).
-
(2009)
Qual. Life Res.
, vol.18
, pp. 881-888
-
-
Klem, M.1
Saghafi, E.2
Abromitis, R.3
Stover, A.4
Dew, M.A.5
Pilkonis, P.6
-
9
-
-
34247363702
-
Evaluation of item candidates: The PROMIS qualitative item review
-
PROMIS Cooperative Group
-
DeWalt, D.A., Rothrock, N., Yount, S. & Stone, A.A.; PROMIS Cooperative Group. Evaluation of item candidates: the PROMIS qualitative item review. Med. Care 45, S12-S21 (2007).
-
(2007)
Med. Care
, vol.45
-
-
Dewalt, D.A.1
Rothrock, N.2
Yount, S.3
Stone, A.A.4
-
10
-
-
67649342633
-
Optimal recall periods for patient-reported outcomes: Challenges and potential solutions
-
Stull, D.E., Leidy, N.K., Parasuraman, B. & Chassany, O. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr. Med. Res. Opin. 25, 929-942 (2009).
-
(2009)
Curr. Med. Res. Opin.
, vol.25
, pp. 929-942
-
-
Stull, D.E.1
Leidy, N.K.2
Parasuraman, B.3
Chassany, O.4
-
11
-
-
0030208867
-
Structural limits on verb mapping: The role of analogy in children's interpretations of sentences
-
DOI 10.1006/cogp.1996.0012
-
Fisher, C. Structural limits on verb mapping: the role of analogy in children's interpretations of sentences. Cogn. Psychol. 31, 41-81 (1996). (Pubitemid 126375581)
-
(1996)
Cognitive Psychology
, vol.31
, Issue.1
, pp. 41-81
-
-
Fisher, C.1
-
12
-
-
77952511914
-
The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for healthrelated patient-reported outcomes
-
Mokkink, L.B. et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for healthrelated patient-reported outcomes. J. Clin. Epidemiol. 63, 737-745 (2010).
-
(2010)
J. Clin. Epidemiol.
, vol.63
, pp. 737-745
-
-
Mokkink, L.B.1
-
14
-
-
78349261942
-
Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: Systematic review
-
Rahimi, K., Malhotra, A., Banning, A.P. & Jenkinson, C. Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review. BMJ 341, c5707 (2010).
-
(2010)
BMJ
, vol.341
-
-
Rahimi, K.1
Malhotra, A.2
Banning, A.P.3
Jenkinson, C.4
-
15
-
-
35449006752
-
Patient-reported outcomes in cancer: A review of recent research and policy initiatives
-
DOI 10.3322/CA.57.5.278
-
Lipscomb, J., Gotay, C.C. & Snyder, C.F. Patient-reported outcomes in cancer: a review of recent research and policy initiatives. CA Cancer J. Clin. 57, 278-300 (2007). (Pubitemid 47628455)
-
(2007)
CA Cancer Journal for Clinicians
, vol.57
, Issue.5
, pp. 278-300
-
-
Lipscomb, J.1
Gotay, C.C.2
Snyder, C.F.3
-
16
-
-
70449718833
-
Quality of life in patients with metastatic renal cell carcinoma: The importance of patient-reported outcomes
-
Cella, D. Quality of life in patients with metastatic renal cell carcinoma: the importance of patient-reported outcomes. Cancer Treat. Rev. 35, 733-737 (2009).
-
(2009)
Cancer Treat. Rev.
, vol.35
, pp. 733-737
-
-
Cella, D.1
-
17
-
-
1842630354
-
The relationship between literacy and cognition in well-educated elders
-
Barnes, D.E., Tager, I.B., Satariano, W.A. & Yaffe, K. The relationship between literacy and cognition in well-educated elders. J. Gerontol. A Biol. Sci. Med. Sci. 59, 390-395 (2004). (Pubitemid 38478739)
-
(2004)
Journals of Gerontology - Series A Biological Sciences and Medical Sciences
, vol.59
, Issue.4
, pp. 390-395
-
-
Barnes, D.E.1
Tager, I.B.2
Satariano, W.A.3
Yaffe, K.4
-
18
-
-
0026877917
-
The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection
-
Ware, J.E. Jr & Sherbourne, C.D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med. Care. 30, 473-483 (1992).
-
(1992)
Med. Care.
, vol.30
, pp. 473-483
-
-
Ware Jr., J.E.1
Sherbourne, C.D.2
-
19
-
-
0019827980
-
The sickness impact profile: Development and final revision of a health status measure
-
DOI 10.1097/00005650-198108000-00001
-
Bergner, M., Bobbitt, R.A., Carter, W.B. & Gilson, B.S. The Sickness Impact Profile: development and final revision of a health status measure. Med. Care 19, 787-805 (1981). (Pubitemid 11021288)
-
(1981)
Medical Care
, vol.19
, Issue.8
, pp. 787-805
-
-
Bergner, M.1
Bobbitt, R.A.2
-
22
-
-
84878693772
-
Development of a functional assessment of chronic illness therapy questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors: The FACT-EGFRI
-
Chicago, IL 4-8 June
-
Wagner, L.I. et al. Development of a Functional Assessment of Chronic Illness Therapy questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors: The FACT-EGFRI. Meeting of the American Society of Clinical Oncology, Chicago, IL, 4-8 June 2010.
-
(2010)
Meeting of the American Society of Clinical Oncology
-
-
Wagner, L.I.1
-
23
-
-
0031449904
-
Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument
-
DOI 10.1016/S0090-4295(97)00459-7, PII S0090429597004597
-
Esper, P., Mo, F., Chodak, G., Sinner, M., Cella, D. & Pienta, K.J. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology 50, 920-928 (1997). (Pubitemid 28021111)
-
(1997)
Urology
, vol.50
, Issue.6
, pp. 920-928
-
-
Esper, P.1
Mo, F.2
Chodak, G.3
Sinner, M.4
Cella, D.5
Pienta, K.J.6
-
24
-
-
0037080113
-
Fatigue in cancer patients compared with fatigue in the general United States population
-
DOI 10.1002/cncr.10245
-
Cella, D., Lai, J.S., Chang, C.H., Peterman, A. & Slavin, M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer 94, 528-538 (2002). (Pubitemid 34081385)
-
(2002)
Cancer
, vol.94
, Issue.2
, pp. 528-538
-
-
Cella, D.1
Lai, J.-S.2
Chang, C.-H.3
Peterman, A.4
Slavin, M.5
-
25
-
-
33748904355
-
The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria
-
DOI 10.1056/NEJMoa061648
-
Hillmen, P. et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N. Engl. J. Med. 355, 1233-1243 (2006). (Pubitemid 44427447)
-
(2006)
New England Journal of Medicine
, vol.355
, Issue.12
, pp. 1233-1243
-
-
Hillmen, P.1
Young, N.S.2
Schubert, J.3
Brodsky, R.A.4
Socie, G.5
Muus, P.6
Roth, A.7
Szer, J.8
Elebute, M.O.9
Nakamura, R.10
Browne, P.11
Risitano, A.M.12
Hill, A.13
Schrezenmeier, H.14
Fu, C.-L.15
Maciejewski, J.16
Rollins, S.A.17
Mojcik, C.F.18
Rother, R.P.19
Luzzatto, L.20
more..
-
26
-
-
84857037276
-
-
About Soliris Cheshire CT
-
About Soliris. Alexion Pharmaceuticals, Cheshire, CT, 1999-2011 〈http://www.alxn.com/SolirisAndPNH/AboutSoliris/Default.aspx〉.
-
(1999)
Alexion Pharmaceuticals
-
-
-
27
-
-
77956393388
-
The development of a clinical outcomes survey research application: Assessment Center
-
Gershon, R., Rothrock, N.E., Hanrahan, R.T., Jansky, L.J., Harniss, M., Riley, W. The development of a clinical outcomes survey research application: Assessment Center. Qual. Life Res. 19, 677-685 (2010).
-
(2010)
Qual. Life Res.
, vol.19
, pp. 677-685
-
-
Gershon, R.1
Rothrock, N.E.2
Hanrahan, R.T.3
Jansky, L.J.4
Harniss, M.5
Riley, W.6
-
28
-
-
34247360479
-
Developing the patient-reported outcomes measurement information system (PROMIS)
-
Ader, D.N. Developing the patient-reported outcomes measurement information system (PROMIS). Med. Care. 45(5 suppl. 1), S1-S2 (2007).
-
(2007)
Med. Care.
, vol.45
, Issue.5 SUPPL. 1
-
-
Ader, D.N.1
-
29
-
-
77956946593
-
The patient reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks
-
Cella, D. et al. The patient reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks. J. Clin. Epidemiol. 63, 1179-1194 (2010).
-
(2010)
J. Clin. Epidemiol.
, vol.63
, pp. 1179-1194
-
-
Cella, D.1
-
30
-
-
77956957760
-
Relative to the general US population, chronic diseases are associated with poorer health-related quality of life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
-
Rothrock, N.E., Hays, R.D., Spritzer, K., Yount, S.E., Riley, W. & Cella, D. Relative to the general US population, chronic diseases are associated with poorer health-related quality of life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS). J. Clin. Epidemiol. 63, 1195-1204 (2010).
-
(2010)
J. Clin. Epidemiol.
, vol.63
, pp. 1195-1204
-
-
Rothrock, N.E.1
Hays, R.D.2
Spritzer, K.3
Yount, S.E.4
Riley, W.5
Cella, D.6
-
31
-
-
79961205531
-
Analysis of differential item functioning in the depression item bank from the Patient Reported Outcome Measurement Information System (PROMIS): An item response theory approach
-
Teresi, J.A. et al. Analysis of differential item functioning in the depression item bank from the Patient Reported Outcome Measurement Information System (PROMIS): An item response theory approach. Psychol. Sci. Q. 51, 148-180 (2009).
-
(2009)
Psychol. Sci. Q.
, vol.51
, pp. 148-180
-
-
Teresi, J.A.1
-
32
-
-
0037567512
-
Defining clinically meaningful change in health-related quality of life
-
DOI 10.1016/S0895-4356(03)00044-1
-
Crosby, R.D., Kolotkin, R.L. & Williams, G.R. Defining clinically meaningful change in health-related quality of life. J. Clin. Epidemiol. 56, 395-407 (2003). (Pubitemid 36694091)
-
(2003)
Journal of Clinical Epidemiology
, vol.56
, Issue.5
, pp. 395-407
-
-
Crosby, R.D.1
Kolotkin, R.L.2
Williams, G.R.3
-
33
-
-
79953292342
-
Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients
-
Yost, K.J., Eton, D.T., Garcia, S.F. & Cella, D. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. J. Clin. Epidemiol. 64, 507-516 (2011).
-
(2011)
J. Clin. Epidemiol.
, vol.64
, pp. 507-516
-
-
Yost, K.J.1
Eton, D.T.2
Garcia, S.F.3
Cella, D.4
-
34
-
-
18244368960
-
A comprehensive method for the translation and cross-cultural validation of health status questionnaires
-
DOI 10.1177/0163278705275342
-
Eremenco, S.L., Cella, D. & Arnold, B.J. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval. Health Prof. 28, 212-232 (2005). (Pubitemid 40628908)
-
(2005)
Evaluation and the Health Professions
, vol.28
, Issue.2
, pp. 212-232
-
-
Eremenco, S.L.1
Cella, D.2
Arnold, B.J.3
-
35
-
-
80053358359
-
The neurology quality of life measurement (Neuro-QOL) initiative
-
in press
-
Cella, D. et al. The neurology quality of life measurement (Neuro-QOL) initiative. Arch. Phys. Med. Rehabil., in press.
-
Arch. Phys. Med. Rehabil
-
-
Cella, D.1
-
36
-
-
80055024644
-
Quality of life outcomes in children with neurological conditions: Pediatric Neuro-QOL
-
e-pub ahead of print 25 July 2011
-
Lai, J.S. et al. Quality of life outcomes in children with neurological conditions: Pediatric Neuro-QOL. Neurorehabil. Neural Repair. (2011): e-pub ahead of print 25 July 2011.
-
(2011)
Neurorehabil. Neural Repair.
-
-
Lai, J.S.1
|