9 hasil untuk "Heather Draper"
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Artikel Jurnal Teks lengkap
A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines
Background: Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Methods and findings: Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews…
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Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.
Background: Assessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal ‘PRO alerts’: psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may…
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Potential research participants’ use of information during the consent process: A qualitative pilot study of patients enrolled in a clinical trial
There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants’ use of consent discussions and information sheets…
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Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists
Background: Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary…
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Informing Potential Participants about Research: Observational Study with an Embedded Randomized Controlled Trial
Objectives: To assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant’s accessed; 3) to assess satisfaction and understanding. Design: Observational study with an embedded randomised…
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Patient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review
Background: Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on ‘in-trial’ activity (recruitment, data…
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Artikel Jurnal Teks lengkap
Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers
Background: Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help…
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Artikel Jurnal Teks lengkap
Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols
Background: Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study…