A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey

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Abstract

Background

The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. Evidence regarding the effectiveness of NAS prevention and management strategies is very weak and further research initiatives are critically needed to support meta-analysis and clinical practice guidelines. In NAS research, the choice of outcomes and the use of valid, responsive and feasible measurement instruments are crucial. There is currently no consensus and evidence-based core outcome set (COS) for NAS.

Methods/design

The development of the NAS-COS will include five stages led by an international Multidisciplinary Steering Committee: (1) qualitative interviews with parents/families and a systematic review (SR) to identify items for inclusion in a COS. The SR will also identify participants for the Delphi survey, (2) a three-round Delphi survey to gain expert opinion on the importance of health outcomes influencing NAS management decisions, (3), a consensus meeting to finalize the items and definitions with experts and COS users, (4) feasibility and pilot testing, development of the COS and explanatory document and (5) implementation planning.

Discussion

Since standardized outcome measurement and reporting will improve NAS clinical research consistency, efficacy and impact, this COS will reflect the minimum set of health outcomes which should be measured in trials evaluating interventions for preventing or treating NAS.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-016-1666-9) contains supplementary material, which is available to authorized users.

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Prevalence and characteristics of opioid use in the US adult population.

Karon Cook, Judith Kelly, Chase Anderson … (2008)

This report describes the prevalence of opioid use in the US adult population, overall and in subgroups, the characteristics of opioid use, and concomitant medication use among opioid users. Data were obtained from the Slone Survey, a population-based random-digit dialing survey. One household member was randomly selected to answer a series of questions regarding all medications taken during the previous week. There were 19,150 subjects aged > or = 18 interviewed from 1998 to 2006. Opioids were used 'regularly' ( > or = 5 days per week for > or = 4 weeks) by 2.0%; an additional 2.9% used opioids less frequently. Regular opioid use increased with age, decreased with education level, and was more common in females and in non-Hispanic whites. The prevalence of regular opioid use increased over time and was highest in the South Central region. Nearly one-fifth of regular users had been taking opioids for > or = 5 years. Concomitant use of > or = 10 non-opioid medications was reported by 21% of regular opioid users compared to 4.5% of subjects who did not use opioids. Regular opioid users were more likely to use stool softeners/laxatives (9% vs. 2%), proton pump inhibitors (25% vs. 8%), and antidepressants (35% vs. 10%). From this nationally-representative telephone survey, we estimate that over 4.3 million US adults are taking opioids regularly in any given week. Information on the prevalence and characteristics of use is important as opioids are one of the most widely prescribed classes of drugs in the US.

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Author and article information

Contributors

Lauren E. Kelly: (416) 813-7654 , lauren.elyse.kelly@gmail.com

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 8 November 2016

Publication date PMC-release: 8 November 2016

Publication date Collection: 2016

Volume: 17

Electronic Location Identifier: 536

Affiliations

[1 ]Child Health and Evaluative Sciences, the Hospital for Sick Children, Toronto, ON Canada

[2 ]Johns Hopkins University School of Medicine, Baltimore, MD USA

[3 ]Neonatal Intensive Care Unit, Aubrey and Marla Dan Program for High Risk Mothers and Babies, Sunnybrook Health Sciences Centre, Toronto, ON Canada

[4 ]Women’s and Infant’s Program, St. Joseph’s Healthcare, Hamilton, ON Canada

[5 ]Department of Pediatrics, the Hospital for Sick Children, Toronto, ON Canada

[6 ]Institute for Clinical Evaluative Sciences, Toronto, ON Canada

[7 ]Intensive Care and Department of Surgery, Erasmus MC-Sophia Children’s Hospital, Rotterdam, The Netherlands

[8 ]Department of Development and Regeneration, KU Leuven, Leuven, Belgium

[9 ]NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW Australia

[10 ]Faculty of Medicine and Dentistry, Department of Paediatrics, Western University, London, ON Canada

[11 ]Department of Pediatrics, Alberta Health Services and the Cumming School of Medicine, University of Calgary, Calgary, AB Canada

[12 ]Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA USA

[13 ]College on Problems of Drug Dependence, Philadelphia, PA USA

[14 ]Department of Biostatistics, University of Liverpool, Liverpool, England

[15 ]Faculty of Medicine, Department of Pediatrics, University of Toronto, Toronto, ON Canada

Article

Publisher ID: 1666

DOI: 10.1186/s13063-016-1666-9

PMC ID: 5100193

SO-VID: c5f34f32-1ba1-45fc-8aba-257614a16142

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 23 August 2016

Date accepted : 21 October 2016

Funding

Funded by: No funding was received.

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ScienceOpen disciplines: Medicine

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ScienceOpen disciplines: Medicine

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