Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences

Murad, M. Hassan; Shah, Nilay D.; Houten, Holly K. Van; Ziegenfuss, Jeanette Y.; Deming, James R.; Beebe, Timothy J.; Smith, Steven A.; Guyatt, Gordon; Montori, Víctor M.

doi:10.1016/j.jclinepi.2010.08.005

Cited by 62 publications

(55 citation statements)

References 11 publications

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“…Several guideline documents have been developed by members of these two organisations [10] and by other societies and federations [2,[11][12][13][14][15]. However, an update was deemed necessary because of contemporary information on the benefits/risks of glycaemic control, recent evidence concerning efficacy and safety of several new drug classes [16,17], the withdrawal/restriction of others and increasing calls for a move towards more patient-centred care [18,19].…”

Section: Introductionmentioning

confidence: 99%

Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2012

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Section: Introductionmentioning

confidence: 99%

Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2012

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“…Additionally, a recent survey from 2036 patients with diabetes showed that most of them (>75%) chose patient-important outcomes rather than HbA1c as their first choice for a trial primary outcome [36]. Patients understand the reality of their condition and disease’s impact on their lives better than physicians can do [37].…”

Section: Discussionmentioning

confidence: 99%

Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review

Gaudry

Messika

Ricard

et al. 2017

Ann. Intensive Care

101

106

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BackgroundIntensivists’ clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients.MethodsLiterature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other).ResultsOf the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge.ConclusionPatient-important outcomes are rarely primary outcomes in RCTs in critically ill patients published in 2013. Among them, mortality accounted for the majority. We promote the use of patient-important outcomes in critical care trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s13613-017-0243-z) contains supplementary material, which is available to authorized users.

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“…Patient-centered care is an approach to clinical care that is consistently recommended for patients with diabetes [32–34] and which encompasses specific communication strategies such as partnership building, expressing empathy, interpersonal sensitivity, mutual exchange of information and collaborative goal setting. Mutual understanding between provider and patient is integral, such that both parties appreciate current diabetes clinical status and future management goals within the context of the patient’s daily life, including their culture and values, family, and social and community environment 35–36].…”

Section: Patient-centered Approach To Diabetes Carementioning

confidence: 99%

New Approaches to Providing Individualized Diabetes Care in the 21st Century

Powell

Corathers²,

Raymond³

et al. 2015

CDR

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Building from a foundation of rapid innovation, the 21st century is poised to offer considerable new approaches to providing modern diabetes care. The focus of this paper is the evolving role of diabetes care providers collaboratively working with patients and families toward the goals of achieving optimal clinical and psychosocial outcomes for individuals living with diabetes. Advances in monitoring, treatment and technology have been complemented by trends toward patient-centered care with expertise from multiple health care disciplines. The evolving clinical care delivery system extends far beyond adjustment of insulin regimens. Effective integration of patient-centered strategies, such as shared-decision making, motivational interviewing techniques, shared medical appointments, and multidisciplinary team collaboration, into a dynamic model of diabetes care delivery holds promise in reaching glycemic targets and improving patients’ quality of life.

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Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences

Cited by 62 publications

References 11 publications

Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review

New Approaches to Providing Individualized Diabetes Care in the 21st Century

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