Cargando…

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 coll...

Descripción completa

Detalles Bibliográficos
Autores principales:	Kyte, Derek G., Draper, Heather, Ives, Jonathan, Liles, Clive, Gheorghe, Adrian, Calvert, Melanie
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Public Library of Science 2013
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3613381/ https://www.ncbi.nlm.nih.gov/pubmed/23560103 http://dx.doi.org/10.1371/journal.pone.0060684

Ejemplares similares

Correction: Patient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review
por: Kyte, Derek G., et al.
Publicado: (2014)

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers
por: Calvert, Melanie, et al.
Publicado: (2014)

Current practices in patient-reported outcome (PRO) data collection in clinical trials: a cross-sectional survey of UK trial staff and management
por: Kyte, Derek, et al.
Publicado: (2016)

Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.
por: Kyte, Derek, et al.
Publicado: (2016)

Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols
por: Kyte, Derek, et al.
Publicado: (2014)

Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists
por: Kyte, Derek, et al.
Publicado: (2013)

Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists
por: Kyte, Derek, et al.
Publicado: (2013)

The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles, experiences, challenges and training
por: Mercieca-Bebber, Rebecca, et al.
Publicado: (2017)

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review protocol
por: Aiyegbusi, Olalekan Lee, et al.
Publicado: (2016)

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review
por: Aiyegbusi, Olalekan Lee, et al.
Publicado: (2017)

Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study
por: Gheorghe, Adrian, et al.
Publicado: (2013)

The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis
por: Rivera, Samantha Cruz, et al.
Publicado: (2019)

A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice
por: Mercieca-Bebber, Rebecca, et al.
Publicado: (2017)

The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders
por: Cruz Rivera, Samantha, et al.
Publicado: (2020)

Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol
por: Kyte, Derek, et al.
Publicado: (2018)

Patient-Reported Outcomes (PROs) in COPD Clinical Trials: Trends and Gaps
por: Afroz, Nuzhat, et al.
Publicado: (2020)

Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials
por: Kyte, Derek, et al.
Publicado: (2019)

Patient-reported outcomes (PROs) in randomised controlled trials in diabetes and pregnancy: protocol for a systematic review
por: Newman, Christine, et al.
Publicado: (2021)

Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance
por: Aiyegbusi, Olalekan Lee, et al.
Publicado: (2022)

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company
por: Arpinelli, Fabio, et al.
Publicado: (2006)

Health Data Processes: A Framework for Analyzing and Discussing Efficient Use and Reuse of Health Data With a Focus on Patient-Reported Outcome Measures
por: Hjollund, Niels Henrik Ingvar, et al.
Publicado: (2019)

Potential research participants’ use of information during the consent process: A qualitative pilot study of patients enrolled in a clinical trial
por: Jenkins, Simon Paul, et al.
Publicado: (2020)

Patient-reported outcome measures used in patients with primary sclerosing cholangitis: a systematic review
por: Isa, Fatima, et al.
Publicado: (2018)

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease
por: Kyte, Derek, et al.
Publicado: (2022)

Informing Potential Participants about Research: Observational Study with an Embedded Randomized Controlled Trial
por: Kirkby, Helen M., et al.
Publicado: (2013)

International perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study
por: Retzer, Ameeta, et al.
Publicado: (2021)

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol
por: Ahmed, Khaled, et al.
Publicado: (2016)

Patient reported outcome measures in rare diseases: a narrative review
por: Slade, Anita, et al.
Publicado: (2018)

Electronic patient-reported outcomes in chronic kidney disease
por: Anderson, Nicola, et al.
Publicado: (2022)

Use of the kidney failure risk equation to inform clinical care of patients with chronic kidney disease: a mixed-methods systematic review
por: Bhachu, Harjeet Kaur, et al.
Publicado: (2022)

Using patient-reported outcome measures (PROMs) to promote quality of care in the management of patients with established kidney disease requiring treatment with haemodialysis in the UK (PROM-HD): a qualitative study protocol
por: Anderson, Nicola Elzabeth, et al.
Publicado: (2018)

Systematic review of the use of translated patient-reported outcome measures in cancer trials
por: Slade, A. L., et al.
Publicado: (2021)

Assessing the impact of healthcare research: A systematic review of methodological frameworks
por: Cruz Rivera, Samantha, et al.
Publicado: (2017)

Global use of electronic patient-reported outcome systems in nephrology: a mixed methods study
por: Anderson, Nicola Elizabeth, et al.
Publicado: (2023)

‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension
por: Cruz Rivera, Samantha, et al.
Publicado: (2021)

Patient and clinician opinions of patient reported outcome measures (PROMs) in the management of patients with rare diseases: a qualitative study
por: Aiyegbusi, Olalekan Lee, et al.
Publicado: (2020)

Using patient-reported outcome measures during the management of patients with end-stage kidney disease requiring treatment with haemodialysis (PROM-HD): a qualitative study
por: Anderson, Nicola Elzabeth, et al.
Publicado: (2021)

Electronic patient reported outcomes to support care of patients with traumatic brain injury: PRiORiTy study qualitative protocol
por: Retzer, Ameeta, et al.
Publicado: (2019)

Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes
por: Bell, Melanie L, et al.
Publicado: (2018)

Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs)
por: Weldring, Theresa, et al.
Publicado: (2013)

Cannot write session to /tmp/vufind_sessions/sess_cg94t3v82qmsuulg2am8pu0vrf