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Record Nr. |
UNINA9910459535203321 |
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Titolo |
ePro [[electronic resource] ] : electronic solutions for patient-reported data / / edited by Bill Byrom and Brian Tiplady |
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Pubbl/distr/stampa |
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Farnham, Surrey, England ; ; Burlington, VT, : Gower, c2010 |
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ISBN |
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1-317-14191-1 |
1-317-14190-3 |
1-282-85767-3 |
9786612857676 |
1-4094-1242-3 |
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Descrizione fisica |
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1 online resource (297 p.) |
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Altri autori (Persone) |
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Disciplina |
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Soggetti |
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Clinical trials - Data processing |
Outcome assessment (Medical care) - Data processing |
Electronic books. |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Cover; Contents; List of Figures; List of Tables; Foreword; About the Editors; List of Contributors; Introduction; 1 Recall Bias: Understanding and Reducing Bias in PRO Data Collection; 2 Cognitive Interviewing: The use of Cognitive Interviews to Evaluate ePRO Instruments; 3 Data Quality and Power in Clinical Trials: A Comparison of ePRO and Paper in a Randomized Trial; 4 Regulation and Compliance; 5 Selection of a Suitable ePRO Solution: Benefit, Cost and Risk; 6 Patient Compliance in an ePRO Environment; 7 Computerized Clinical Assessments |
8 Diary Design Considerations: Interface Issues and Patient Acceptability9 Equivalence Testing: Validation and Supporting Evidence When Using Modified PRO Instruments; 10 ePRO Applications and Personal Mobile Phone Use: Compliance Documentation and Patient Support; 11 Future Developments and Applications: Emerging Technologies and New Approaches to Patients; Index |
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Sommario/riassunto |
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Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies |
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