Research in neonatology: a global perspective

Meyer, Sascha; Butte, Mona; Gortner, Ludwig

doi:10.1111/apa.12305

Cited by 3 publications

(2 citation statements)

References 4 publications

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“…Neonatology is one of the most fertile fields in clinical research, where practice recommendations based on findings from RCTs conducted over six decades have improved the care of the newborn, especially the very premature and those with low birth weights [22, 23]. As part of the COMET initiative, efforts to define a core outcome set in neonatal trials have been undertaken in the form of Core Outcomes in Neonatology (COIN).…”

Section: Introductionmentioning

confidence: 99%

How Often Are Patient-Important Outcomes Represented in Neonatal Randomized Controlled Trials? An Analysis of Cochrane Neonatal Reviews

Lai

Leom²,

Chow³

et al. 2020

Neonatology

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Background: Research findings based on patient-important outcomes (PIOs) provide more useful conclusions than those that are based on surrogate outcomes. It is unclear to what extent PIOs are represented in neonatal randomized controlled trials (RCTs). Objectives: We determined the proportion of PIOs in neonatal RCTs included in Cochrane Neonatal reviews. Methods: We extracted up to 5 outcomes from each RCT included in Cochrane Neonatal reviews published until January 2018, with independent determination of PIOs among authors followed by a discussion leading to a consensus. We defined PIOs as outcomes that matter to patient care, such as clinical events or physiological or laboratory parameters that are widely used to guide management. Results: Among 6,832 outcomes extracted from 1,874 RCTs included in 276 reviews, 5,349 (78.3%) were considered PIOs; 461 studies (24.5%) included 5 or more PIOs, 1,278 (68.2%) included 1–4 PIOs, while 135 (7.2%) had no PIO included. PIOs were observed more often among dichotomous than among continuous outcomes (94.9 vs. 61.5%; RR: 1.54; 95% CI: 1.50–1.58), and more among subjective than among objective outcomes (95.9 vs. 76.8%; RR: 1.25; 95% CI: 1.22–1.28). Newer studies were more likely to have a greater number of PIOs (adjusted OR: 1.033 [95% CI: 1.025–1.041] with each publication year). Conclusions: The large and increasing representation of PIOs over the years suggests an improving awareness by neonatal trialists of the need to incorporate important outcomes in order to justify the utilization of resources. Further research should explore the reasons for non-inclusion or non-reporting of PIOs in a small proportion of RCTs.

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Section: Introductionmentioning

confidence: 99%

How Often Are Patient-Important Outcomes Represented in Neonatal Randomized Controlled Trials? An Analysis of Cochrane Neonatal Reviews

Lai

Leom²,

Chow³

et al. 2020

Neonatology

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“…Moreover, it will be important to take into consideration geographic, political and economic aspects. In low and middle income countries, enteral feeding concepts may very well vary quite substantially from those applied in highly-industrialized Western countries given the differences between these countries [40]. Data from the German Neonatal Network (GNN) in the year 2010 demonstrated that in addition to respiratory pathology the majority of non-survivors (221/2.221) suffered from potentially preventable diseases (inflammatory diseases including sepsis or NEC) [5].…”

Section: Resultsmentioning

confidence: 99%

Conservative Enteral Feeding Policy and Necrotizing Enterocolitis (NEC) in VLBW Infants: A Single Center Experience

Butte¹,

Lindner²,

Sauer³

et al. 2014

JPNC

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Are Neonatal Trials Better Conducted and Reported over the Last 6 Decades? An Analysis on Their Risk-of-Bias Status in Cochrane Reviews

Lai

Ong²,

Chen

et al. 2019

Neonatology

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Background: The introduction of Neonatology as a subspecialty in 1960 has stimulated an enormous amount of neonatal research. A large proportion of neonatal randomized-controlled trials (RCTs) have been included in the Cochrane reviews, within which methodological quality or risk-of-bias (ROB) assessment is an integral feature. Objectives: We described the ROB profile of neonatal RCTs published since the 1950s. Methods: We analyzed individual studies within the Cochrane Neonatal reviews published up to December 2016. We extracted the reviewers’ judgments on the ROB domains including random sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting. We evaluated blinding of personnel in trials in which blinding was considered feasible. Results: We assessed 1980 RCTs published between 1952 and 2016 from 294 Cochrane Neonatal systematic reviews, with full ROB assessments performed in 848 trials (42.8%). Among the ROB domains, the highest proportion of trials (73%) were judged as satisfactory (“low risk”) in handling incomplete outcome data, while fewest trials achieved blinding of outcome assessor (38.4%). In the last 6 decades, a progressive increase has been observed in the proportion of trials that were rated as low risk in random sequence generation, allocation concealment, and selective reporting. However, blinding was achieved in less than half of the trials with no clear improvement across decades (23–44% since the 1980s). Conclusions: Despite steady improvement in the overall quality of neonatal RCTs over the last 6 decades, blinding remained unsatisfactory in the majority of the trials.

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Research in neonatology: a global perspective

Cited by 3 publications

References 4 publications

How Often Are Patient-Important Outcomes Represented in Neonatal Randomized Controlled Trials? An Analysis of Cochrane Neonatal Reviews

How Often Are Patient-Important Outcomes Represented in Neonatal Randomized Controlled Trials? An Analysis of Cochrane Neonatal Reviews

Conservative Enteral Feeding Policy and Necrotizing Enterocolitis (NEC) in VLBW Infants: A Single Center Experience

Are Neonatal Trials Better Conducted and Reported over the Last 6 Decades? An Analysis on Their Risk-of-Bias Status in Cochrane Reviews

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