A Core Outcome Set for Neonatal Opioid Withdrawal Syndrome

Kelly, Lauren; Shan, Flora; MacVicar, Sonya; Czaplinksi, Emily; Moulsdale, Wendy; Simpson, Sarah; Allegaert, Karel; Jansson, Lauren M.; Offringa, Martin

doi:10.1542/peds.2020-0018

Cited by 21 publications

(14 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…After completion of our study, researchers developed a Core Outcome Set for Neonatal Opioid Withdrawal Syndrome to guide future research efforts 27 . Our investigation included several of these core outcomes including need for pharmacologic treatment, total dose of opioid treatment, duration of treatment, feeding di culties, parent-infant bonding (rooming-in), length of stay, breastmilk at discharge, weight gain at discharge.…”

Section: Discussionmentioning

confidence: 99%

Morphine Versus Methadone for Neonatal Opioid Withdrawal Syndrome: A Randomized Controlled Pilot Study

Sutter

Watson²,

Yonke

et al. 2021

Preprint

View full text Add to dashboard Cite

Background Neonatal Opioid Withdrawal Syndrome (NOWS) is a significant public health issue and while millions of neonates are affected each year, an optimal pharmacologic weaning protocol has yet to be demonstrated. In this study, we compare hospital length of stay (LOS) and length of treatment (LOT) for treatment of neonatal opioid withdrawal (NOWS) with morphine versus methadone. Methods This was a single-site, open-label, randomized controlled pilot study conducted from October 2016-June 2018. Infants were eligible if their primary in-utero drug exposure was heroin, oral opioids, or methadone and they were born at greater than or equal to 34 weeks gestation. Infants were excluded for serious medical comorbidities and primary in-utero exposure to buprenorphine. Results 61 infants were enrolled; 30 were randomized to methadone treatment, and 31 to morphine treatment. Overall 46% of infants required treatment for NOWS. LOS and LOT for infants treated with morphine was 17.9 days and 14.7 days respectively, compared to 16.1 days and 12.8 days for babies treated with methadone (p=0.5, p=0.54). Infants treated with morphine received lower total morphine equivalents than those treated with methadone (9.7 vs. 33, p<0.01). Three treated infants in the methadone group required transfer to the Neonatal Intensive Care Unit, versus no infants in the morphine group. Conclusions Infants treated with morphine versus methadone had no significant differences in LOS or LOT in this pilot study. Infants treated with methadone received up to 3 times the opioid based on morphine equivalents as infants treated with morphine and had more transfers to the NICU for over sedation. Clinical Trial Registration: Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome NCT02851303, initated 01/08/2016 https://clinicaltrials.gov/ct2/show/NCT02851303.

show abstract

Section: Discussionmentioning

confidence: 99%

Morphine Versus Methadone for Neonatal Opioid Withdrawal Syndrome: A Randomized Controlled Pilot Study

Sutter

Watson²,

Yonke

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…In past COS investigations, semi-structured interviews were commonly employed to obtain patient perspectives. 32, 33 Therefore, we will conduct semi-structured patient interviews to supplement patient concerns but not reported outcomes.…”

Section: Methods and Analysismentioning

confidence: 99%

Development of a core outcome set on traditional Chinese medicine (COS-TCM) for rheumatic heart disease (RHD): study protocol

Sheng

Chen

et al. 2022

Preprint

View full text Add to dashboard Cite

Introduction: Rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents globally. Clinical trials on RHD treatment with traditional Chinese medicine (TCM) are gradually increasing in China. However, because clinical trials are heterogeneous and report outcomes selectively, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, diminishes the value of clinical trials, and results in a waste of research resources. Therefore, there is an urgent need to develop a core outcome set of traditional Chinese medicine for rheumatic heart disease (COS-TCM-RHD). This study will report the protocol development process for COS-TCM-RHD. Methods and analysis: A multidisciplinary Steering Committee will lead the development of this protocol through four stages (1). Establishing a comprehensive and systematic outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centers, patient's semi-structured interviews, and clinician's questionnaire surveys; (2). Screen stakeholder groups from various fields to participate in the Delphi survey; (3). Two rounds of e-Delphi surveys will be conducted to determine the outcomes of various concerned stakeholder groups; (4). Hold a face-to-face consensus meeting to develop the COS-TCM-RHD. Ethics and dissemination: Ethical approval has been granted by the Evidence-based Medicine Centre of Tianjin University of Traditional Chinese Medicine Research Ethics Committee. The findings will be published in peer-reviewed journals and the website of Chinese Clinical Trials for Core Outcome Set. Trial registration: This study protocol has been prospectively registered with the Core Outcome Measures in Effectiveness Trials (COMET): http://www.comet-initiative.org/Studies/Details/1743.

show abstract

“…And we are aware of at least two additional finalized COS which were excluded from this review since the focus is on the new-born [81,82].…”

Section: Published Core Outcome Setsmentioning

confidence: 99%

Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review

Österberg

Hellberg

Jonsson

et al. 2021

BMC Pregnancy Childbirth

View full text Add to dashboard Cite

Background Systematic reviews often conclude low confidence in the results due to heterogeneity in the reported outcomes. A Core Outcome Set (COS) is an agreed standardised collection of outcomes for a specific area of health. The outcomes included in a COS are to be measured and summarized in clinical trials as well as systematic reviews to counteract this heterogeneity. Aim The aim is to identify, compile and assess final and ongoing studies that are prioritizing outcomes in the area of pregnancy and childbirth. Methods All studies which prioritized outcomes related to pregnancy and childbirth using consensus method, including Delphi surveys or consensus meetings were included. Searches were conducted in Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL, SocINDEX and COMET databases up to June 2021. For all studies fulfilling the inclusion criteria, information regarding outcomes as well as population, method, and setting was extracted. In addition, reporting in the finalized studies was assessed using a modified version of the Core Outcome Set–STAndards for Reporting. Results In total, 27 finalized studies and 42 ongoing studies were assessed as relevant and were included. In the finalized studies, the number of outcomes included in the COS ranged from 6 to 51 with a median of 13 outcomes. The majority of the identified COS, both finalized as well as ongoing, were relating to physical complications during pregnancy. Conclusion There is a growing number of Core Outcome Set studies related to pregnancy and childbirth. Although several of the finalized studies follow the proposed reporting, there are still some items that are not always clearly reported. Additionally, several of the identified COS contained a large number (n > 20) outcomes, something that possibly could hinder implementation. Therefore, there is a need to consider the number of outcomes which may be included in a COS to render it optimal for future research.

show abstract

A Core Outcome Set for Neonatal Opioid Withdrawal Syndrome

Cited by 21 publications

References 28 publications

Morphine Versus Methadone for Neonatal Opioid Withdrawal Syndrome: A Randomized Controlled Pilot Study

Morphine Versus Methadone for Neonatal Opioid Withdrawal Syndrome: A Randomized Controlled Pilot Study

Development of a core outcome set on traditional Chinese medicine (COS-TCM) for rheumatic heart disease (RHD): study protocol

Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review

Contact Info

Product

Resources

About