Skip to main content
Erschienen in: The Patient - Patient-Centered Outcomes Research 3/2010

01.09.2010 | Commentary

Electronic Patient Diaries and Questionnaires — ePRO Now Delivering on the Promise

verfasst von: Professor Brian Tiplady

Erschienen in: The Patient - Patient-Centered Outcomes Research | Ausgabe 3/2010

Einloggen, um Zugang zu erhalten

Excerpt

The importance of patient-reported outcomes (PRO) measures, such as patient symptom diaries and quality of life (QOL) questionnaires, will hardly need emphasizing to the readers of this journal. PROs are increasingly being collected by electronic methods (ePRO). In this commentary, I consider several topics that arise with the use of ePRO, including different ePRO methods and their impact on data quality; how patients respond to using ePRO methods; and issues around validation of ePRO methods and equivalence to existing paper methods. I shall be dealing here with quantitative methods used as outcome measures in clinical research, not with qualitative methods, or the use of ePRO in routine clinical practice. …
Literatur
1.
Zurück zum Zitat Stone AA, Broderick JE, Shiffman S, et al. Understanding recall of weekly pain from a momentary assessment perspective: absolute agreement, between- and within-person consistency, and judged change in weekly pain. Pain 2004; 107: 61–9PubMedCrossRef Stone AA, Broderick JE, Shiffman S, et al. Understanding recall of weekly pain from a momentary assessment perspective: absolute agreement, between- and within-person consistency, and judged change in weekly pain. Pain 2004; 107: 61–9PubMedCrossRef
2.
Zurück zum Zitat Stull DE, Leidy NK, Parasuraman B, et al. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin 2009; 25: 929–42PubMedCrossRef Stull DE, Leidy NK, Parasuraman B, et al. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin 2009; 25: 929–42PubMedCrossRef
3.
Zurück zum Zitat Stone AA, Shiffman S, Schwartz JE, et al. Patient non-compliance with paper diaries. BMJ 2002; 324: 1193–4PubMedCrossRef Stone AA, Shiffman S, Schwartz JE, et al. Patient non-compliance with paper diaries. BMJ 2002; 324: 1193–4PubMedCrossRef
4.
Zurück zum Zitat US Food and Drug Administration. Guidance for industry: patient-reported outcome measures. Use in medical product development to support labeling claims. Washington, DC: US Department of Health and Human Services, 2009 US Food and Drug Administration. Guidance for industry: patient-reported outcome measures. Use in medical product development to support labeling claims. Washington, DC: US Department of Health and Human Services, 2009
5.
Zurück zum Zitat McKenzie S, Paty J, Rosano M, et al. Trial power: how eDiary data can enhance the power and reduce the sample size in clinical trials. Appl Clin Trials 2004; 13: 54–68 McKenzie S, Paty J, Rosano M, et al. Trial power: how eDiary data can enhance the power and reduce the sample size in clinical trials. Appl Clin Trials 2004; 13: 54–68
6.
Zurück zum Zitat Ganser A, Raymond S, Pearson J. Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial. In: Byrom B, Tiplady B, editors. ePRO: electronic solutions for patient reported data. Farnham: Gower. In Press Ganser A, Raymond S, Pearson J. Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial. In: Byrom B, Tiplady B, editors. ePRO: electronic solutions for patient reported data. Farnham: Gower. In Press
7.
Zurück zum Zitat Bernhard J, Cella DF, Coates AS, et al. Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 1998; 17: 517–32PubMedCrossRef Bernhard J, Cella DF, Coates AS, et al. Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 1998; 17: 517–32PubMedCrossRef
8.
Zurück zum Zitat Jerndal P, Garn T, Palmblad M, et al. The symptom relieving effect of omeprazole 20 mg b.i.d versus placebo in patients presenting with functional dyspepsia [Data collection report no. SH-OMD-0003-1]. Mölndal: Astra Hässle (now AstraZeneca), 1996 (Data on file) Jerndal P, Garn T, Palmblad M, et al. The symptom relieving effect of omeprazole 20 mg b.i.d versus placebo in patients presenting with functional dyspepsia [Data collection report no. SH-OMD-0003-1]. Mölndal: Astra Hässle (now AstraZeneca), 1996 (Data on file)
9.
Zurück zum Zitat Tiplady B, Crompton GK, Dewar MH, et al. The use of electronic diaries in respiratory studies. Drug Inf J 1997; 31: 759–64CrossRef Tiplady B, Crompton GK, Dewar MH, et al. The use of electronic diaries in respiratory studies. Drug Inf J 1997; 31: 759–64CrossRef
10.
Zurück zum Zitat Palmblad M, Tiplady B. Electronic diaries and questionnaires: designing user interfaces that are easy for all patients to use. Qual Life Res 2004; 13: 1199–207PubMedCrossRef Palmblad M, Tiplady B. Electronic diaries and questionnaires: designing user interfaces that are easy for all patients to use. Qual Life Res 2004; 13: 1199–207PubMedCrossRef
11.
Zurück zum Zitat Nyholm D, Kowalski J, Aquilonius SM. Wireless real-time electronic data capture for self-assessment of motor function and quality of life in Parkinson’s disease. Mov Disord 2004; 19: 446–51PubMedCrossRef Nyholm D, Kowalski J, Aquilonius SM. Wireless real-time electronic data capture for self-assessment of motor function and quality of life in Parkinson’s disease. Mov Disord 2004; 19: 446–51PubMedCrossRef
12.
Zurück zum Zitat Pierce J, Tiplady B. PDA or IVR based patient-reported outcomes systems: criteria to be considered when selecting an electronic PRO technology [white paper]. Pittsburgh (PA): invivodata®, 2009 [online]. Available from URL: http://www.invivodata.com/epro-resources/epro-technology-options/ [Accessed 2010 Jan 21] Pierce J, Tiplady B. PDA or IVR based patient-reported outcomes systems: criteria to be considered when selecting an electronic PRO technology [white paper]. Pittsburgh (PA): invivodata®, 2009 [online]. Available from URL: http://​www.​invivodata.​com/​epro-resources/​epro-technology-options/​ [Accessed 2010 Jan 21]
13.
Zurück zum Zitat Shields A, Gwaltney C, Tiplady B, et al. Grasping the FDA’s PRO guidance. Appl Clin Trials 2006; 15: 69–72 Shields A, Gwaltney C, Tiplady B, et al. Grasping the FDA’s PRO guidance. Appl Clin Trials 2006; 15: 69–72
14.
Zurück zum Zitat Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force Report. Value Health 2009; 12: 419–29PubMedCrossRef Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force Report. Value Health 2009; 12: 419–29PubMedCrossRef
15.
Zurück zum Zitat Gwaltney CJ, Shields AL, Shiffman S. Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: a meta-analytic review. Value Health 2008; 11:322–33PubMedCrossRef Gwaltney CJ, Shields AL, Shiffman S. Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: a meta-analytic review. Value Health 2008; 11:322–33PubMedCrossRef
16.
Zurück zum Zitat Lundy JJ, Coons SJ. Testing the measurement equivalence of interactive voice response (IVR) and paper versions of the EQ-5D. Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 11th Annual European Congress; 2008 Nov 8–11; Athens Lundy JJ, Coons SJ. Testing the measurement equivalence of interactive voice response (IVR) and paper versions of the EQ-5D. Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 11th Annual European Congress; 2008 Nov 8–11; Athens
17.
Zurück zum Zitat Fries JF, Cella D, Rose M, et al. Progress in assessing physical function in arthritis: PROMIS short forms and computerized adaptive testing. J Rheumatol 2009; 36: 2061–6PubMedCrossRef Fries JF, Cella D, Rose M, et al. Progress in assessing physical function in arthritis: PROMIS short forms and computerized adaptive testing. J Rheumatol 2009; 36: 2061–6PubMedCrossRef
18.
Zurück zum Zitat Solomon KD, Donnenfeld ED, Raizman M, et al. Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients. J Cataract Refract Surg 2004; 30: 1653–60PubMedCrossRef Solomon KD, Donnenfeld ED, Raizman M, et al. Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients. J Cataract Refract Surg 2004; 30: 1653–60PubMedCrossRef
19.
Zurück zum Zitat Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep 2003; 26: 793–9PubMed Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep 2003; 26: 793–9PubMed
20.
Zurück zum Zitat Clauw DJ, Mease P, Palmer RH, et al. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther 2008; 30: 1988–2004PubMedCrossRef Clauw DJ, Mease P, Palmer RH, et al. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther 2008; 30: 1988–2004PubMedCrossRef
21.
Zurück zum Zitat Climara Pro® prescribing information [online]. Available from URL: http://dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?id=10549#nlm34076-0 [Accessed 2010 May 5] Climara Pro® prescribing information [online]. Available from URL: http://​dailymed.​nlm.​nih.​gov/​dailymed/​drugInfo.​ cfm?id=10549#nlm34076-0 [Accessed 2010 May 5]
Metadaten
Titel
Electronic Patient Diaries and Questionnaires — ePRO Now Delivering on the Promise
verfasst von
Professor Brian Tiplady
Publikationsdatum
01.09.2010
Verlag
Springer International Publishing
Erschienen in
The Patient - Patient-Centered Outcomes Research / Ausgabe 3/2010
Print ISSN: 1178-1653
Elektronische ISSN: 1178-1661
DOI
https://doi.org/10.2165/11537600-000000000-00000

Weitere Artikel der Ausgabe 3/2010

The Patient - Patient-Centered Outcomes Research 3/2010 Zur Ausgabe