Loss to Analysis in Randomized Controlled Trials in CKD

Deo, Aneet; Schmid, Christopher H.; Earley, Amy; Lau, Joseph; Uhlig, Katrin

doi:10.1053/j.ajkd.2011.04.023

Cited by 33 publications

(19 citation statements)

References 15 publications

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“…Also, the proportion of trials within nephrology analyzed by Strippoli et al increased over time but remained the lowest of 12 subspecialties evaluated (1.2%). 8 This previous study and a more recent study by Deo et al 9 also highlighted that the reporting of key elements that are essential to a well-designed trial are more likely to be missing from nephrology trials. In general, our findings for more recently registered trials are similar but also provide a snapshot of studies that are underway and have yet to be published.…”

Section: Discussionmentioning

confidence: 93%

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

Inrig

Califf

Tasneem

et al. 2014

American Journal of Kidney Diseases

127

104

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Background Well-designed trials are of paramount importance in improving the delivery of care to patients with kidney disease. However, it remains unknown whether contemporary clinical trials within nephrology are of sufficient quality and quantity to meet this need. Study Design Systematic review. Setting & Population Studies registered with ClinicalTrials.gov. Selection Criteria for Studies Interventional (i.e., non-observational) studies (both randomized and nonrandomized) registered between October 2007 and September 2010 were included for analysis. Studies were independently reviewed by physicians and classified by clinical specialty. Predictor Nephrology versus cardiology versus other trials. Outcomes Select clinical trial characteristics. Results Of the 40,970 trials overall, 1054 (2.6%) were classified as nephrology. The majority of nephrology trials were for treatment (75.4%) or prevention (15.7%), with very few diagnostic, screening, or health services research studies. Most nephrology trials were randomized (72.3%), including 24.9% that included a single study group, 64.0% that included parallel groups, and 9.4% that were crossover trials. Nephrology trials, compared with 2264 cardiology trials (5.5% overall), were more likely to be smaller (64.5% versus 48.0% enrolling ≤100 patients), phase I-II (29.0% versus 19.7%), and unblinded (66.2% versus 53.3%; P<0.05 for all). Nephrology trials were also more likely than cardiology trials to include a drug intervention (72.4% versus 41.9%) and were less likely to report having a data monitoring committee (40.3% versus 48.5%; P<0.05 for all). Finally, there were few trials funded by the National Institutes of Health (3.3%, nephrology; 4.2%, cardiology). Limitations Does not include all trials performed worldwide, and frequent categorization of funding source as university may underestimate NIH support. Conclusions Critical differences remain between clinical trials in nephrology and other specialties. Improving care for patients with kidney disease will require a concerted effort to increase the scope, quality, and quantity of clinical trials within nephrology.

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Section: Discussionmentioning

confidence: 93%

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

Inrig

Califf

Tasneem

et al. 2014

American Journal of Kidney Diseases

127

104

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“…Nekoliko je parametara kojima pratimo kvalitetu studija, od njih su najvažniji: jasna randomizacija, slijepa studija, "intention to treat" analiza i praćenje pacijenata. Deo i suradnici ispitali su tri karakteristike kvalitete u studijama publiciranim u nefrologiji 2007. i 2008. godine 7 . Njihovi rezultati pokazali su da je gotovo dvije trećine studija od 110 izabranih izostavljalo sudionike iz analize, od toga je više od polovice studija izostavilo više od 10 % njih.…”

Section: Uvodunclassified

“…Njihovi rezultati pokazali su da je gotovo dvije trećine studija od 110 izabranih izostavljalo sudionike iz analize, od toga je više od polovice studija izostavilo više od 10 % njih. Polovica svih studija nije učinila "intention to treat" analizu ili su prikazani rezultati i metodologija bili nejasni, a manje od 5 % studija objasnilo je razloge ispalih podataka 7 . Nakon radova Strippolija i suradnika publicirano je nekoliko preglednih članaka koji su na različite načine kritički sagledavali stanje u nefrologiji.…”

Section: Uvodunclassified

Znanost temeljena na dokazima u nefrologiji, dijalizi i transplantaciji bubrega

Peršić

Rački

2017

Med flum

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Sažetak. Nefrologija je mlada grana interne medicine čiji razvoj započinje 60-ih godina prošlog stoljeća uvođenjem nadomještanja bubrežne funkcije u svakodnevnu kliničku praksu. Nakon gotovo pola stoljeća i publiciranog velikog broja studija pokazalo se da je velik broj njih upitne kvalitete te je zaključeno da nefrološkoj struci nedostaju randomizirane studije visoke kvalitete. Učinjeno je niz akcija u suradnji i s nefrološkom Cochrane grupom s ciljem unapređenja struke te su date jasne preporuke za buduća klinička istraživanja. Nefrološka Cochrane grupa prihvatila je tri naslova naše grupe u Rijeci i u fazi smo izrade protokola o prevenciji kontrastne nefropatije.Ključne riječi: kontrastna nefropatija; kronična bubrežna bolest; nefrologija; randomizirane kontrolirane studije.Abstract. Nephrology is a young branch of internal medicine whose development began in the 60s of the last century by introducing the renal replacement therapy in everyday clinical practice. After nearly half a century of publicity, it has been shown that a large number of studies are of questionable quality and it has been concluded that the nephrology lacked randomized controlled trials of high quality. A series of actions were carried out in cooperation with the renal Cochrane group with the aim of advancing the profession and giving clear recommendations for future clinical research. Our group in Rijeka has three review titles accepted in the renal Cochrane group and we have been drafting a protocol on the prevention of contrast nephropathy.

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“…However, the kidney community has generated fewer randomized, controlled trials than any internal medicine specialty, produced a limited number of innovative drugs and devices, and received less funding from public and private sources compared with other diseases. [1][2][3] A significant proportion of the United States adult population has CKD, 4 individuals with CKD are 16-40 times more likely to die from cardiovascular disease than to reach ESRD, 5 ESRD is responsible for the death of more Americans than breast and prostate cancer combined, 6 and blacks, Native Americans, and Latinos are at significantly greater risk for CKD, resulting in serious health disparity issues. [7][8][9] These realities have failed to sufficiently drive public awareness, industry innovation, and research funding.…”

mentioning

confidence: 99%

Overcoming Barriers in Kidney Health—Forging a Platform for Innovation

Linde

Archdeacon

Breyer

et al. 2016

JASN

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Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology. Citing such inequities, however, is not enough. Changing the status quo will require a coordinated effort to identify and redress the existing deficits. Specifically, these deficits relate to the need to further develop and improve the following: understanding of the disease mechanisms and pathophysiology, patient engagement and activism, clinical trial infrastructure, and investigational clinical trial designs as well as coordinated efforts among critical stakeholders. This paper identifies potential solutions to these barriers, some of which are already underway through the Kidney Health Initiative. The Kidney Health Initiative is unique and will serve as a current and future platform from which to overcome these barriers to innovation in nephrology.

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Loss to Analysis in Randomized Controlled Trials in CKD

Cited by 33 publications

References 15 publications

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

Znanost temeljena na dokazima u nefrologiji, dijalizi i transplantaciji bubrega

Overcoming Barriers in Kidney Health—Forging a Platform for Innovation

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