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open access
Health and Quality of Life Outcomes (multi-national)
To inform clinical guidelines and patient care we need high quality evidence on the
relative benefits and harms of intervention. Patient reported outcome (PRO) data from
clinical trials can "empower patients to make decisions based on their values" and
"level the playing field between physician and patient". While clinicians have a good
understanding of the concept of health-related quality of life and other PROs, evidence
suggests that many do not feel comfortable in using the data from trials to inform
discussions with patients and clinical practice. This may in part reflect concerns
over the integrity of the data and difficulties in interpreting the results arising
from poor reporting.The new CONSORT PRO extension aims to improve the reporting of
PROs in trials to facilitate the use of results to inform clinical practice and health
policy. While the CONSORT PRO extension is an important first step in the process,
we need broader engagement with the guidance to facilitate optimal reporting and maximize
use of PRO data in a clinical setting. Endorsement by journal editors, authors and
peer reviewers are crucial steps. Improved design, implementation and transparent
reporting of PROs in clinical trials are necessary to provide high quality evidence
to inform evidence synthesis and clinical practice guidelines.
Background
Randomized controlled clinical trials (RCTs) can provide high-quality data regarding the impact of study interventions on patient outcomes, and remain the ‘gold standard’ of evidence regarding both the benefits and harms associated with an intervention. Over the last twenty years, the number of clinical trials that assess patient reported outcomes (PROs) has
substantially increased [1]. PROs can be defined as a “measurement of any aspect of a patient’s health status that comes directly from the patient (i.e. without the interpretation of the patient’s responses by a physician or anyone else” [2] and include health-related quality
of life (HRQL), symptoms, satisfaction and adherence to medication. These subjective measures of outcome help evaluate the burden of disease and treatment from the patients’ perspective. In the conceptual framework developed by Till and colleagues adapted in (Figure 1) [3], PRO data from clinical trials may directly inform patients and practitioners, or may indirectly inform clinical practice through evidence synthesis into clinical practice guidelines.....
Randomized controlled clinical trials (RCTs) can provide high-quality data regarding the impact of study interventions on patient outcomes, and remain the ‘gold standard’ of evidence regarding both the benefits and harms associated with an intervention. Over the last twenty years, the number of clinical trials that assess patient reported outcomes (PROs) has
substantially increased [1]. PROs can be defined as a “measurement of any aspect of a patient’s health status that comes directly from the patient (i.e. without the interpretation of the patient’s responses by a physician or anyone else” [2] and include health-related quality
of life (HRQL), symptoms, satisfaction and adherence to medication. These subjective measures of outcome help evaluate the burden of disease and treatment from the patients’ perspective. In the conceptual framework developed by Till and colleagues adapted in (Figure 1) [3], PRO data from clinical trials may directly inform patients and practitioners, or may indirectly inform clinical practice through evidence synthesis into clinical practice guidelines.....
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