Full Text Journal Articles by
Author Samantha Cruz Rivera

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Patient-reported outcomes in the regulatory approval of medical devices.

Samantha Cruz Rivera, Andrew P Dickens, Olalekan Lee Aiyegbusi, Rebecca Flint, Camilla Fleetcroft, Duncan McPherson, Philip Collis, Melanie J Calvert,

Nat Med (Nature medicine)
[2021, :]

Cited: 0 times

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'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.

Samantha Cruz Rivera, Richard Stephens, Rebecca Mercieca-Bebber, Ameeta Retzer, Claudia Rutherford, Gary Price, Anita Slade, Olalekan Lee Aiyegbusi, Philip Edge, Lesley Roberts, Lesley Gosden, Rav Verdi, Roger Wilson, Melanie Calvert,

<h4>Objectives</h4>(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.<h4>Design</h4>A 1-day patient and public involvement session.<h4>Participants</h4>Seven patient ... Read more >>

BMJ Open (BMJ open)
[2021, 11(6):e046450]

Cited: 0 times

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A systematic review assessing the quality of patient reported outcomes measures in dry eye diseases.

Alberto Recchioni, Olalekan Lee Aiyegbusi, Samantha Cruz-Rivera, Saaeha Rauz, Anita Slade,

<h4>Background</h4>Patient-reported outcome measures (PROMs) can provide valuable insights on the impact of a disease or treatment on a patient's health-related quality of life. In ophthalmology, particularly in dry eye disease (DED) and ocular surface disease (OSD), it is unclear whether the available PROMs were developed using comprehensive guidelines. To address ... Read more >>

PLoS One (PloS one)
[2021, 16(8):e0253857]

Cited: 0 times

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Symptoms, complications and management of long COVID: a review.

Olalekan Lee Aiyegbusi, Sarah E Hughes, Grace Turner, Samantha Cruz Rivera, Christel McMullan, Joht Singh Chandan, Shamil Haroon, Gary Price, Elin Haf Davies, Krishnarajah Nirantharakumar, Elizabeth Sapey, Melanie J Calvert, ,

Globally, there are now over 160 million confirmed cases of COVID-19 and more than 3 million deaths. While the majority of infected individuals recover, a significant proportion continue to experience symptoms and complications after their acute illness. Patients with 'long COVID' experience a wide range of physical and mental/psychological symptoms. ... Read more >>

J R Soc Med (Journal of the Royal Society of Medicine)
[2021, 114(9):428-442]

Cited: 3 times

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Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey.

Samantha Cruz Rivera, Barbara Torlinska, Eliot Marston, Alastair K Denniston, Kathy Oliver, Steve Hoare, Melanie J Calvert,

<h4>Background</h4>The UK's transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define ... Read more >>

Ther Innov Regul Sci (Therapeutic innovation & regulatory science)
[2021, 55(4):646-655]

Cited: 1 time

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Protocol for a scoping review exploring the use of patient-reported outcomes in adult social care.

Sarah E Hughes, Olalekan Lee Aiyegbusi, Daniel S Lasserson, Philip Collis, Samantha Cruz Rivera, Christel McMullan, Grace M Turner, Jon Glasby, Melanie Calvert,

<h4>Introduction</h4>Patient-reported outcomes (PROs) are measures of a person's own views of their health, functioning and quality of life. They are typically assessed using validated, self-completed questionnaires known as patient-reported outcome measures (PROMs). PROMs are used in healthcare settings to support care planning, clinical decision-making, patient-practitioner communication and quality improvement. PROMs ... Read more >>

BMJ Open (BMJ open)
[2021, 11(4):e045206]

Cited: 0 times

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The need for ethical guidance for the use of patient-reported outcomes in research and clinical practice.

Samantha Cruz Rivera, Rebecca Mercieca-Bebber, Olalekan Lee Aiyegbusi, Jane Scott, Amanda Hunn, Conrad Fernandez, Jonathan Ives, Carolyn Ells, Gary Price, Heather Draper, Melanie J Calvert,

Nat Med (Nature medicine)
[2021, 27(4):572-573]

Cited: 1 time

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Reporting guidelines for clinical trials of artificial intelligence interventions: the SPIRIT-AI and CONSORT-AI guidelines.

Hussein Ibrahim, Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, An-Wen Chan, Matthew R Sydes, Melanie J Calvert, Alastair K Denniston,

<h4>Background</h4>The application of artificial intelligence (AI) in healthcare is an area of immense interest. The high profile of 'AI in health' means that there are unusually strong drivers to accelerate the introduction and implementation of innovative AI interventions, which may not be supported by the available evidence, and for which ... Read more >>

Trials (Trials)
[2021, 22(1):11]

Cited: 1 time

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Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension.

Samantha Cruz Rivera, Xiaoxuan Liu, An-Wen Chan, Alastair K Denniston, Melanie J Calvert, ,

The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there ... Read more >>

BMJ (BMJ (Clinical research ed.))
[2020, 370:m3210]

Cited: 13 times

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Advancing UK regulatory science and innovation in healthcare.

Melanie J Calvert, Eliot Marston, Mark Samuels, Samantha Cruz Rivera, Barbara Torlinska, Kathy Oliver, Alastair K Denniston, Steve Hoare,

J R Soc Med (Journal of the Royal Society of Medicine)
[2021, 114(1):5-11]

Cited: 2 times

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Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension.

Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie J Calvert, Alastair K Denniston, ,

The CONSORT 2010 statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on ... Read more >>

Lancet Digit Health (The Lancet. Digital health)
[2020, 2(10):e537-e548]

Cited: 6 times

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Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.

Samantha Cruz Rivera, Xiaoxuan Liu, An-Wen Chan, Alastair K Denniston, Melanie J Calvert, , , ,

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving ... Read more >>

Nat Med (Nature medicine)
[2020, 26(9):1351-1363]

Cited: 27 times

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The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders.

Samantha Cruz Rivera, Christel McMullan, Laura Jones, Derek Kyte, Anita Slade, Melanie Calvert,

<h4>Background</h4>Patient-reported outcomes (PROs) are increasingly collected in clinical trials as they provide unique information on the physical, functional and psychological impact of a treatment from the patient's perspective. Recent research suggests that PRO trial data have the potential to inform shared decision-making, support pharmaceutical labelling claims and influence healthcare policy ... Read more >>

J Patient Rep Outcomes (Journal of patient-reported outcomes)
[2020, 4(1):51]

Cited: 0 times

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Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension.

Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie J Calvert, Alastair K Denniston, ,

The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to ... Read more >>

BMJ (BMJ (Clinical research ed.))
[2020, 370:m3164]

Cited: 11 times

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Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension.

Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie J Calvert, Alastair K Denniston, ,

The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on ... Read more >>

Nat Med (Nature medicine)
[2020, 26(9):1364-1374]

Cited: 34 times

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Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.

Samantha Cruz Rivera, Xiaoxuan Liu, An-Wen Chan, Alastair K Denniston, Melanie J Calvert, ,

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving ... Read more >>

Lancet Digit Health (The Lancet. Digital health)
[2020, 2(10):e549-e560]

Cited: 8 times

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Author Correction: Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed.

,

An amendment to this paper has been published and can be accessed via a link at the top of the paper. ... Read more >>

Nat Med (Nature medicine)
[2019, 25(12):1948]

Cited: 0 times

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The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis.

Samantha Cruz Rivera, Derek G Kyte, Olalekan Lee Aiyegbusi, Anita L Slade, Christel McMullan, Melanie J Calvert,

<h4>Background</h4>Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, ... Read more >>

Health Qual Life Outcomes (Health and quality of life outcomes)
[2019, 17(1):156]

Cited: 14 times

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Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed.

,

Nat Med (Nature medicine)
[2019, 25(10):1467-1468]

Cited: 26 times

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Assessing the impact of healthcare research: A systematic review of methodological frameworks.

Samantha Cruz Rivera, Derek G Kyte, Olalekan Lee Aiyegbusi, Thomas J Keeley, Melanie J Calvert,

<h4>Background</h4>Increasingly, researchers need to demonstrate the impact of their research to their sponsors, funders, and fellow academics. However, the most appropriate way of measuring the impact of healthcare research is subject to debate. We aimed to identify the existing methodological frameworks used to measure healthcare research impact and to summarise ... Read more >>

PLoS Med (PLoS medicine)
[2017, 14(8):e1002370]

Cited: 28 times

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