Supplement: Early onset Group B streptococcal disease

Transcription

1 Supplement: Early onset Group B streptococcal disease

2 Table of Contents 1 Introduction Funding Conflict of interest Guideline review Methodology Topic identification Scope Clinical questions Exclusions Search strategy Consultation Endorsement Publication Levels of evidence Summary recommendations Implementation Guideline resources Suggested resources Implementation measures Program measures District Health Service measures Clinical quality measures...7 List of Tables Table 1. Summary of change... 3 Table 2. PICO Framework... 4 Table 3. Major guideline development processes... 5 Table 4. Levels of evidence... 6 Table 5. Summary recommendations... 6 This work is licensed under a Creative Commons Attribution Non-Commercial No Derivatives 2.5 Australia licence. To view a copy of this licence, visit State of Queensland (Queensland Health) 2010 In essence you are free to copy and communicate the work in its current form for non-commercial purposes, as long as you attribute the authors and abide by the licence terms. You may not alter or adapt the work in any way. For permissions beyond the scope of this licence contact: Intellectual Property Officer, Queensland Health, GPO Box 48, Brisbane Qld 4001, ip_officer@health.qld.gov.au, phone (07) For further information contact Queensland Maternity and Neonatal Clinical Guidelines Program, RBWH Post Office, Herston Qld 4029, MN-Guidelines@health.qld.gov.au phone (07) Refer to online version, destroy printed copies after use Page 2 of 7

3 1 Introduction This document is a supplement to the Maternity and Neonatal Clinical Guideline Early onset Group B Streptococcal disease. It provides supplementary information regarding guideline development, makes summary recommendations, suggests measures to assist implementation and quality activities and summarises changes (if any) to the guideline since original publication. Refer to the guideline for abbreviations, acronyms, flow charts and acknowledgements. 1.1 Funding The development of this guideline was funded by Queensland Health. Working party members participated on a voluntary basis. 1.2 Conflict of interest No conflict of interest was identified 1.3 Guideline review The Maternity and Neonatal Clinical Guidelines are reviewed every 5 years or earlier if significant new evidence emerges. Table 1 provides a summary of changes made to the guidelines since original publication. Table 1. Summary of change Publication date Identifier Summary of major change November 2010 MN V1-R13 First publication Replaces inherited guideline Flenady V, 2007 Prevention of neonatal early onset Group B streptococcus disease (EOGBSD) August 2011 MN10.20-V2-R15 Review date extended. Identifier updated. Program name updated 2 Methodology The Maternity and Neonatal Clinical Guideline Program (the Program) follows a rigorous process of guideline development. This process was endorsed by the Queensland Health Patient Safety and Quality Executive Committee in December The guidelines are best described as "evidence informed consensus guidelines" and draw from the evidence base of existing national and international guidelines and the expert opinion of the working party. 2.1 Topic identification The topic was identified when the existing inherited guideline (Flenady V 2007) reached its review date of January Refer to online version, destroy printed copies after use Page 3 of 7

4 2.2 Scope The scope of the guideline was determined using the PICO Framework (Population, Intervention, Comparison, Outcome) criteria identified in Table 2. Table 2. PICO Framework PICO Population Intervention Comparison Outcome Pregnant women Neonates 7 days old Identification of maternal risk factors for Early onset Group B streptococcal disease Maternal management for identified risk factors Clinical surveillance of the neonate Treatment of suspected neonatal sepsis N/A Accurate assessment of antenatal and intrapartum maternal risk factors for Early onset Group B streptococcal disease Best practice maternal treatment Early detection of neonatal sepsis Best practice neonatal treatment 2.3 Clinical questions The following clinical questions were generated to inform the guideline scope and purpose: What are the maternal risk factors for Early onset Group B streptococcal disease What is the best practice intrapartum management of women with risk factors What clinical surveillance should be recommended for neonates within the first 7 days of life What treatment should be provided to neonates if sepsis is suspected 2.4 Exclusions Late onset Group B streptococcal disease 2.5 Search strategy A search of the literature was conducted during February 2010 using multiple techniques including search and review of: known guideline sites (for example Royal Australian and New Zealand College of Obstetricians and Gynaecologists, National Guideline Clearing House, Royal College of Obstetrician and Gynaecologists, Society of Obstetricians and Gynaecologists of Canada) synthesised evidence (e.g. UpToDate, Cochrane reviews) summaries of relevant literature (e.g. identified using Cinahl, PubMed) individual case reports, studies and trials identified in the literature relevant reference lists Refer to online version, destroy printed copies after use Page 4 of 7

5 2.6 Consultation Major consultative and development processes occurred between April 2010 and August These are outlined in Table 3. Table 3. Major guideline development processes Process Clinical lead Consumer participation Working party Statewide consultation Activity The nominated Clinical Lead was approved by the Program Steering Committee Consumer participation was invited from a range of consumer focused organisations who had previously accepted an invitation for on-going involvement with the Program An EOI for working party membership was distributed via to Queensland clinicians and stakeholders (~1000) in February 2010 The working party was recruited from responses received Working party members who participated in the working party consultation processes are acknowledged in the guideline Working party consultation occurred in a virtual group via during April 2010 and in July 2010 Consultation was invited via from Queensland clinicians and stakeholders (~1000) during June 2010 Feedback was received primarily via All feedback was compiled and provided to the clinical lead and working party members for review and comment 2.7 Endorsement The guideline was endorsed by: The Program Steering Committee in September 2010 Statewide Maternity and Neonatal Clinical Network in September 2010 Queensland Health Patient Safety and Quality Executive Committee in October Publication The guideline was published on the Program website in November 2010 The guideline can be cited as: Queensland Maternity and Neonatal Clinical Guidelines Program. Early onset Group B streptococcal disease Guideline No. MN V2-R15 Queensland Health 2010 The guideline supplement can be cited as: Queensland Maternity and Neonatal Clinical Guidelines Program. Supplement: Early onset Group B streptococcal disease Guideline No. MN V2-R15 Queensland Health 2010 Refer to online version, destroy printed copies after use Page 5 of 7

6 3 Levels of evidence The levels of evidence identified in Flenady V, Jenkins-Manning S (2007) for the Queensland Clinical Practice Guidelines Working Party on the Prevention of Early Onset Group B Streptococcal Disease, Centre for Clinical Studies, Mater Health Services Brisbane, were used to inform the recommendations. Levels of evidence are outlined in Table 4. Summary recommendations are outlined in Table 5. Table 4. Levels of evidence Level of Evidence Grading of Recommendation NHMRC (1999) Adapted from RCOG by Flenady V, Jenkins-Manning S (2007) I II Evidence obtained from a systematic review of all relevant randomised controlled trials Evidence obtained from at least one properly designed randomised controlled trial Evidence obtained from well-designed pseudo randomised controlled trials (alternate allocation or some other method Evidence obtained from comparative studies with concurrent controls and allocation not randomised (cohort studies), case control studies or interrupted time series with a control group Evidence obtained from comparative studies with historical control, two or more single-arm studies, or interrupted time series without a parallel control group A Requires at least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendation III-1 III-2 III-3 B Requires the availability of well-conducted clinical studies on the topics of the recommendation. (Evidence levels III-1, III-2, III-3 or evidence levels I or II where the dimensions of the evidence internal validity, statistical precision, size of the effect and relevance are considered to limit the strength of the evidence) IV Evidence obtained from case series, either post-test or pre-test and post-test C Requires evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates an absence of directly applicable clinical studies of good quality (i.e. where the dimensions of the evidence internal validity, statistical precision, size of the effect and relevance are considered to limit the strength of the evidence) 3.1 Summary recommendations Summary recommendations and levels of evidence are outlined in Table 5 Table 5. Summary recommendations Summary recommendation Grading of evidence Antibiotic prophylaxis should be offered to women with intrapartum risk factors for EOGBSD Risk factors are: Preterm labour <37 weeks Membranes ruptured > 18 hours Maternal temperature 38 O C GBS colonisation this pregnancy GBS bacteriuria this pregnancy Previous infant with EOGBSD Penicillin is the antibiotic of choice for intrapartum chemoprophylaxis for women without penicillin allergy Prevention strategies should include a management protocol for the prevention and treatment of early onset sepsis in the neonate I B III-2 B IV C IV C Refer to online version, destroy printed copies after use Page 6 of 7

7 4 Implementation This guideline is applicable to all Queensland public and private maternity facilities and can be downloaded in Portable Document Format (PDF) from Guideline resources The following guideline components are provided on the website as separate resources: Flowchart: Maternal management of early onset Group B streptococcal disease Flowchart: Neonatal management of early onset Group B streptococcal disease 4.2 Suggested resources During the development process stakeholders identified additional resources with potential to compliment and enhance guideline implementation and application. The following resources have not been sourced or developed by the Program but are suggested as complimentary to the guideline: Patient Information related to Early onset Group B streptococcal disease including preventative strategies Instructions for the collection (and self-collection) of genital swab for the detection of group B streptococcus Cost-benefit analysis of Rapid Polymerase Chain Reaction (PCR) diagnosis of GBS relevant to the Queensland environment of service provision 4.3 Implementation measures Suggested activities to assist implementation of the guideline are outlined below: Program measures Notify Chief Executive Officer and relevant stakeholders Monitor emerging new evidence to ensure guideline reflects contemporaneous practice Capture user feedback Record and manage change requests Conduct satisfaction survey within 2 years of implementation Review the guideline in District Health Service measures Table the guideline at the local Patient Safety and Quality Committee meeting Replace all other guidelines on this topic with the current version of this guideline Promote the introduction of the guideline to relevant health care professionals. For example at staff forums, clinical handovers, incorporate into orientation packages Develop or access suggested resources as identified in the guideline, section 4.2 of this guideline. 4.4 Clinical quality measures The following clinical quality measures are suggested: Identification of an agreed Statewide (private and public) data set for the monitoring of GBS in newborn populations (including for example, Indigenous status as EOGBSD is anecdotally reported as higher among Indigenous populations) Collection and monitoring of the documented incidence of GBS culture results in newborn populations using an agreed data set. This will inform subsequent review of the effectiveness of the risk factor approach in identifying pregnant women for prophylactic intrapartum antibiotics in Queensland Refer to online version, destroy printed copies after use Page 7 of 7