Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach

Morgans, Alicia K.; Bommel, A.C.M. van; Stowell, Caleb; Abrahm, Janet L.; Basch, Ethan; Bekelman, Justin E.; Berry, Donna L.; Bossi, Alberto; Davis, Ian D.; Reijke, Theo M. de; Denis, L.; Evans, Sue; Fleshner, Neil; George, Daniel J.; Kiefert, James J.; Lin, Daniel W.; Matthew, Andrew; McDermott, Ray; Payne, Heather; Roos, Ian; Schrag, Deborah; Steuber, Thomas; Tombal, B.; Basten, Jean-Paul van; Hoeven, J.J.M. van der; Penson, David F.

doi:10.1016/j.eururo.2015.06.007

Cited by 95 publications

(105 citation statements)

References 23 publications

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“…Patient-important outcomes are gaining wide acceptance in some fields of clinical research [33–35]. 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].…”

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

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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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

106

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“…Importantly even less is known about the impact of novel therapies when used in other clinical settings where patients may have co-morbidities and characteristics that make them ineligible for treatment within a trial. Routine collection of a standard set of outcomes such as those recommended for prostate cancer trials 35 or more recently others developed by the ICHOM group 36 , which come directly from patients in clinic, might be invaluable to build up sufficient 'real-world' data to aid decision-making.…”

Section: Conclusion/perspectivesmentioning

confidence: 99%

Patient-reported outcomes in metastatic castration-resistant prostate cancer

2016

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“…Sommige kwaliteitsregistratie-initiatieven, zoals die van Santeon [12] en het International Consortium for Health Outcomes Measurement (www.ichom.org), richten zich vooral op uitkomstindicatoren en de bijbehorende casemixvariabelen [13,14]. Nadeel van deze focus is dat veel uitkomsten, zoals recidieven of overleving, pas na langere tijd beschikbaar zijn en vaak multifactorieel en multi-institutioneel tot stand komen, waardoor ze minder informatief zijn voor de individuele zorgaanbieder.…”

Section: Proces En Uitkomstindicatorenunclassified

Kwaliteitsregistraties volgens het principe van ‘clinical auditing’

Wouters

2017

Tijdschr Urol

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Samenvatting Wetenschappelijke verenigingen van medisch specialisten hebben de afgelopen jaren kwaliteitsregistraties geïnitieerd die zijn opgezet volgens het clinical-auditing principe. Het primaire doel van deze landelijke audits is het verbeteren van zorguitkomsten, door behandelaars te voorzien van spiegelinformatie, waarmee zij de kwaliteit van hun zorgproces kunnen monitoren en verbeteren. Directe betrokkenheid van dokters bij de opzet en uitvoering van de audit, tijdige terugkoppeling van kwaliteitsaspecten die door henzelf belangrijk worden gevonden en het proactief volgen van ontwikkelingen in de zorg, zijn essentieel voor het succes van kwaliteitsregistraties. De mogelijkheid voor behandelaars om resultaten te monitoren, richtlijnnavolging en de introductie van de mogelijkheid om nieuwe technieken te evalueren en met kwaliteitsintiatieven hun uitkomsten te verbeteren, heeft tot substantiële vermindering van morbiditeit en mortaliteit geleid op diverse chirurgische terreinen. Registratie aan de bron, structurele financiering en goede afspraken over transparantie, zijn essentieel om clinical auditing te bestendigen als krachtig instrument in het kwaliteitsbeleid van wetenschappelijke verenigingen.

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Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach

Abstract: Our international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer.

Cited by 95 publications

References 23 publications

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

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

Patient-reported outcomes in metastatic castration-resistant prostate cancer

Kwaliteitsregistraties volgens het principe van ‘clinical auditing’

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