Discussion

Ja, Sacristán; Soto, Javier; Galende, I; Tr, Hylan

doi:10.1016/s0895-4356(98)00058-4

Cited by 17 publications

(4 citation statements)

References 1 publication

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“…This would contribute not only to the more efficient generation of new and relevant knowledge for patients but also to a speedier application of the results. The enormous development of electronic health records and information technologies could help in carrying out randomized database studies 47 (or randomized registry trials), a method recently termed “the next disruptive technology” in clinical research. 48 This method proposes the integration of research modules into usual clinical practice in order to combine the main strengths of randomized controlled trials (ie, initial randomization) and registries (ie, naturalistic follow-up).…”

Section: Improving Access To Clinical Trialsmentioning

confidence: 99%

Patient involvement in clinical research: why, when, and how

Sacristán¹,

Aguarón²,

Avendaño-Solá³

et al. 2016

PPA

290

252

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The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.

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Section: Improving Access To Clinical Trialsmentioning

confidence: 99%

Patient involvement in clinical research: why, when, and how

Sacristán¹,

Aguarón²,

Avendaño-Solá³

et al. 2016

PPA

290

252

View full text Add to dashboard Cite

show abstract

“…Researchers can exploit EMRs containing a vast amount of information generated by each medical interaction. The idea of applying randomization to EMRs would enable “randomized database studies”, which combine the advantages of observational studies and experimental studies [57]. The incorporation of decision aids could encourage quicker application of the knowledge acquired during research [58].…”

Section: Discussionmentioning

confidence: 99%

Patient-centered medicine and patient-oriented research: improving health outcomes for individual patients

Sacristán

2013

BMC Med Inform Decis Mak

229

197

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BackgroundPatient-centered medicine is developing alongside the concepts of personalized medicine and tailored therapeutics. The main objective of patient-centered medicine is to improve health outcomes of individual patients in everyday clinical practice, taking into account the patient’s objectives, preferences, values as well as the available economic resources.DiscussionPatient-centered medicine implies a paradigm shift in the relationship between doctors and patients, but also requires the development of patient-oriented research. Patient-oriented research should not be based on the evaluation of medical interventions in the average patient, but on the identification of the best intervention for every individual patient, the study of heterogeneity and the assignment of greater value to observations and exceptions. The development of information-based technologies can help to close the gap between clinical research and clinical practice, a fundamental step for any advance in this field.SummaryEvidence-based medicine and patient centered medicine are not contradictory but complementary movements. It is not possible to practice patient-centered medicine that is not based on evidence, nor is it possible to practice evidence-based medicine at a distance from the individual patient.

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“…Today, one of the main challenges in clinical research is how to integrate experiments into routine clinical practice. The idea of conducting “ Randomized Database Studies ”, that was proposed fifteen years ago as a possible solution to combine the main strengths of randomized controlled trials (i.e., initial randomization) and registries (i.e., naturalistic follow-up) [ 53 ], may represent a new and disruptive paradigm in clinical research [ 54 ]. There are several recent examples of pragmatic trials that exploit routinely collected data to quickly demonstrate effectiveness in real-world care delivery systems [ 55 , 56 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical research and medical care: towards effective and complete integration

Sacristán

2015

BMC Med Res Methodol

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BackgroundDespite their close relationship, clinical research and medical care have become separated by clear boundaries. The purpose of clinical research is to generate generalizable knowledge useful for future patients, whereas medical care aims to promote the well-being of individual patients. The evolution towards patient-centered medicine and patient-oriented research, and the gradual standardization of medicine are contributing to closer ties between clinical research and medical practice. But the integration of both activities requires addressing important ethical and methodological challenges.DiscussionFrom an ethical perspective, clinical research should evolve from a position of paternalistic beneficence to a situation in which the principle of non-maleficence and patient autonomy predominate. The progressive adoption of “patient-oriented informed consent”, “patient equipoise”, and “altruism-based research”, and the application of risk-based ethical oversight, in which the level of regulatory scrutiny is adapted to the potential risk for patients, are crucial steps to achieve the integration between research and care.From a methodological standpoint, careful and systematic observations should have greater relevance in clinical research, and experiments should be embedded into usual clinical practice. Clinical research should focus on individuals through the development of patient-oriented research. In a complementary way, the integration of experiments into medical practice through the systematic application of “point of care research” could help to generate knowledge for the individuals and for the populations.SummaryThe integration of clinical research and medical care will require researchers, clinicians, health care managers, and patients to reevaluate the way they understand both activities. The development of an integrated learning health care system will contribute to generating and applying clinically relevant medical knowledge, producing benefits for present and future patients.

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Discussion

Cited by 17 publications

References 1 publication

Patient involvement in clinical research: why, when, and how

Patient involvement in clinical research: why, when, and how

Patient-centered medicine and patient-oriented research: improving health outcomes for individual patients

Clinical research and medical care: towards effective and complete integration

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