AUSTRALIAN INSTITUTE OF HEALTH INNOVATION Faculty of Medicine and Health Sciences

Systematic reviews of critical values in key laboratory analytes: Program handbook

2

PROGRAM TEAM

Dr Que Lam, AACB-RCPA High Risk Results Working Party

Professor Andrea Rita Horvath, AACB-RCPA High Risk Results Working Party

Professor Andrew Georgiou, Macquarie University

Dr Rae-Anne Hardie, Macquarie University

Ms Julie Li, Macquarie University

Program material prepared and presented by:

Centre for Health Systems and Safety Research Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences Macquarie University, Sydney, Australia June 2019

3

TABLE OF CONTENTS

Program Team ..........................................................................................................................2 Background ..............................................................................................................................4 Course contacts ........................................................................................................................4 Program schedule..................................................................................................................... 5 Training program design ........................................................................................................ 6 On-campus workshop schedule ............................................................................................... 7 Module 1: Developing the research question ......................................................................... 8 Module 2: Synthesis of the search strategy ............................................................................ 8 Module 3: Screening the literature ......................................................................................... 9 Module 4: Data extraction and ............................................................................................... 9 Module 5: Quality assessment (and data ranking) ................................................................. 9 Module 6: Report writing and presentation to AACB ........................................................... 10 Optional Modules for future opportunity .............................................................................. 10 Module 7: Write up ................................................................................................................ 10 Resources ............................................................................................................................... 11

Systematic reviews of critical values in key laboratory analytes: Program handbook

4

BACKGROUND Critical risk results are laboratory results requiring immediate medical attention and action because they indicate a high risk of imminent death or patient harm. The Australasian Association of Clinical Biochemists (AACB)-Royal College of Pathologists of Australasia (RCPA) High Risk Results Working Party aims to publish a list of evidence-based high risk result thresholds for the purpose of harmonising laboratory practices. The work undertaken by participants in the program will contribute to this goal. Successful applicants are supported by scholarships awarded by AACB and RCPA.

This program is offered in conjunction with Macquarie University as part of an NHMRC Partnership project (1111925) with NSW Health Pathology and the Australian Commission on Safety and Quality in Health Care entitled “Delivering safe and effective test-result communication, management and follow-up.”

COURSE CONTACTS

Dr Rae-Anne Hardie

Postdoctoral Research Fellow

Email: aihi.eblm@mq.edu.au

Ms Julie Li

Research Assistant

Email: aihi.eblm@mq.edu.au

Dr Que Lam

AACB-RCPA High Risk Results Working Party

Email: aihi.eblm@mq.edu.au

Systematic reviews of critical values in key laboratory analytes: Program handbook

5

PROGRAM SCHEDULE

Date Modules and deliverables

14 June 2019 Macquarie University Workshop

Weeks 1-2 (17-28 June)

Module 1: Developing the research question

Weeks 3-4 (1-12 July)

Module 2: Synthesis of the search strategy

Week 4 (8-12 July)

Deliverable 1: Submit (a) A search strategy containing keywords and subject headings for each database including inbuilt filters; (b) PROSPERO registration summary before submitting

Weeks 5-10 (15 July-23 August)

Module 3: Screening the literature

Week 6 (22-26 July)

Zoom meeting: Endnote skills workshop

Week 8 (5-9 August)

Zoom meeting: Literature screening Q & A

Week 10

(19-23 August) Deliverable 2: Submit an Endnote library containing all final papers and PRISMA flowchart

Weeks 11-14 (26 August-20 September)

Module 4: Data extraction

Module 5: Quality assessment

Week 11 (26-30 August)

Zoom meeting: Quality assessment workshop

Week 13 (9-13 August)

Zoom meeting: Final data extraction and write up Q & A

Week 15-16 (23 September-4 October)

Module 6: Report writing and presentation to AACB

Week 16 (30 September-4 October)

Deliverable 3 (week 16): Submit report containing (a) 1-page referenced background of the test and its impact on outcomes; (b) Standardised results table; (c) Quality assessment of the level of the underlying evidence

Systematic reviews of critical values in key laboratory analytes: Program handbook

6

TRAINING PROGRAM DESIGN Full-day on-campus workshop covering:

• Introduction to systematic reviews/PROSPERO registration

• Developing a research question, inclusion/exclusion criteria

• Search strategies and key word/headings

• Database searching

• Using Endnote

• How to perform literature screening

• Data extraction and quality assessment

Modules and videoconference workshops: • Conducted over 16 weeks following the on-campus workshop

• Participants will work in teams of 2-3 per analyte

• Analytes will be assigned by the AACB-RCPA/MQ team with all efforts to match participant preference

• MQ will conduct follow-up sessions with each group to ensure projects are tracking well, and provide formal checks and feedback on deliverables

Minimum expectations: • It is expected that participants will be able to dedicate 1-2 full days per week for the

duration of the program and are expected to attend the full-day on-campus workshop and follow-up meetings. Based on this time commitment, the review should be feasible to complete within 16 weeks if all deliverables are completed on schedule

• Deliverables as detailed in this handbook

• Participants will provide AACB-RCPA High Risk Results Working Party with a brief background on the test and what is considered a critical outcome, alert table of results, level of evidence, and quality assessment

On completion, future opportunities to present, publish, or undertake further training may be possible

Systematic reviews of critical values in key laboratory analytes: Program handbook

7

ON-CAMPUS WORKSHOP SCHEDULE Friday, 14th June, 2019 Macquarie University, Level 6, 75 Talavera Road, Macquarie Park

9:30 Morning Tea

10:00 Welcome to Country and introductions Prof Andrew Georgiou

10:15 Introduction to the program Dr Que Lam

10:25 High-level overview of expected commitment for participants to complete the program

Prof Andrew Georgiou

10:30 Housekeeping items: email, library login Dr Rae-Anne Hardie/Julie Li

10:45 Introduction to Evidence-based Laboratory Medicine/PRISMA/PROSPERO registration

Dr Rae-Anne Hardie/Julie Li

11:30 Developing a research question, inclusion/exclusion criteria

Dr Rae-Anne Hardie/Julie Li

12:15 Lunch

13:15 Database searching: search strategies and keywords/headings

Library team (Jane Van Balen and Jeremy Cullis)

14:15 Exporting your papers and using EndNote

Library team (Jane Van Balen and Jeremy Cullis)

15:00 Break

15:15 How to perform literature screening Julie Li/Dr Rae-Anne Hardie

15:45 Data extraction and quality assessment Craig Campbell

16:00 A case study using calcium Wilson Punyalack

16:30 Questions Review Program Handbook & dates

Dr Rae-Anne Hardie/Julie Li

16:45 Closing remarks Dr Que Lam/Prof Andrew Georgiou

17:00 Workshop close

Systematic reviews of critical values in key laboratory analytes: Program handbook

8

MODULE 1: DEVELOPING THE RESEARCH QUESTION

LEARNING OBJECTIVES: 1. Learn to formulate the research question using the PICO (Problem/Patient/Population,

Intervention/Indicator, Comparison, Outcome) framework 2. How to perform an initial hand search and landscape overview of literature 3. How to identify key papers and any related systematic reviews covering the same research

question 4. Learn to develop inclusion and exclusion criteria

MODULE 2: SYNTHESIS OF THE SEARCH STRATEGY

LEARNING OBJECTIVES: 1. Learn how each search database search tool works (e.g. Medline, PubMed, Scopus, EMBASE) 2. Learn how to use key search terms (e.g. MeSH, subject headings, key words) 3. Learn how to enter search shortcuts 4. Learn how to perform and optimise a search strategy that will yield the optimal number of

papers 5. Learn how to filter for date range, language, article type, population, etc. 6. Learn how to save and export searches into EndNote 7. Learn how to document the review steps using PRISMA principles 8. How to register the study in PROSPERO (International prospective register of systematic

reviews)

Deliverable 1 (week 4): Submit (a) A search strategy containing keywords and subject headings for each database including inbuilt filters; (b) PROSPERO registration summary before submitting

Systematic reviews of critical values in key laboratory analytes: Program handbook

9

MODULE 3: SCREENING THE LITERATURE

LEARNING OBJECTIVES: 1. Learn to perform title and abstract screening and evaluation in EndNote 2. Learn how to use Covidence website to perform full text review and screening using pre-set

exclusion criteria 3. Learn how to undertake a decision-making consensus process 4. Learn how to create a new EndNote library containing only the final papers agreed upon after

screening

Deliverable 2 (week 10): Submit an Endnote library containing all final papers and PRISMA flowchart

MODULE 4: DATA EXTRACTION AND

MODULE 5: QUALITY ASSESSMENT (AND DATA RANKING)

LEARNING OBJECTIVES: 1. How to create a data extraction table or database using evidence from each paper to answer

the research question 2. Learn how to perform a quality assessment of each paper and the data using the appropriate

tool. Each paper will be scored using an appraisal tool based on the JAMA users’ guide1 for an article about harm

1 Levine M, Walter S, Lee H, Haines T, Holbrook A, Moyer V. Users' guides to the medical literature. IV. How to use an article about harm. Evidence-Based Medicine Working Group. JAMA. 1994;271(20):1615-9.

Systematic reviews of critical values in key laboratory analytes: Program handbook

10

MODULE 6: REPORT WRITING AND PRESENTATION TO AACB

LEARNING OBJECTIVES: 1. Learn to perform the appropriate statistics on the extracted data 2. Learn to write up and present the results to RCPA-AACB High Risk Results Working Party

Deliverable 3 (week 16): Submit report containing (a) 1-page referenced background of the test and its impact on outcomes; (b) Standardised results table; (c) Quality assessment of the level of the underlying evidence

OPTIONAL MODULES FOR FUTURE OPPORTUNITY

MODULE 7: WRITE UP

LEARNING OBJECTIVES: 1. How to incorporate Working Party feedback 2. How to write up the literature review as a manuscript/systematic review 3. How to present review at conference 4. How to pursue potential further training opportunities, MRes, PhD

Systematic reviews of critical values in key laboratory analytes: Program handbook

11

RESOURCES Throughout the Program, additional Resources will be uploaded here.

Endnote download https://tinyurl.com/endnoteMQ

Macquarie University Library https://tinyurl.com/libraryMQ

Cochrane Library website https://tinyurl.com/cochraneMQ

Covidence website for full text screening https://tinyurl.com/covidence

PICO – a useful tool for asking focused clinical questions https://tinyurl.com/PICOMQ

PRISMA - Preferred Reporting Items for Systematic Reviews and Meta-Analyses

https://tinyurl.com/PRISMAMQ

PROSPERO website for registering review https://tinyurl.com/PROSPEROMQ

Campbell CA, Georgiou A, Westbrook JI, Horvath AR. What alert thresholds should be used to identify critical risk results: A systematic review of the evidence. Clinical Chemistry. 2016; 62(11):1445-57.

https://tinyurl.com/alertthresholds

Campbell CA, Lam Q, Horvath AR. An evidence- and risk-based approach to a harmonized laboratory alert list in Australia and New Zealand. Clinical Chemistry and Laboratory Medicine (CCLM). 2018; 57(1): 89-94.

https://tinyurl.com/harmonizedCCLM

Georgiou A. Finding, appraising and interpreting the evidence of health IT. In: Ammenwerth E, Rigby M, editors. Evidence-Based Health Informatics. Amsterdam: IOS Press; 2016. p. 312-23.

https://tinyurl.com/evidencehealthIT

Horvath AR, Pewsner D. Systematic reviews in laboratory medicine: principles, processes and practical considerations. Clinica Chimica Acta. 2004; 342(1):23-39.

https://tinyurl.com/SRlabmed

Levine M, Walter S, Lee H, Haines T, Holbrook A, Moyer V. Users' guides to the medical literature. IV. How to use an article about harm. Evidence-Based Medicine Working Group. JAMA. 1994;271(20):1615-9.

https://tinyurl.com/levineJAMA

Punyalack W, Hardie R-A, Li L, Li J, Campbell C, Badrick T, Georgiou A. High risk results – the evidence for total serum calcium alert thresholds. Pathology. 2019; 51:S18.

https://tinyurl.com/highriskresults

ABN 90 952 801 237 CRICOS Provider 00002J

FIND OUT MORE Macquarie University NSW 2109 Australia T: +61 (2) 9850 2400 aihi.mq.edu.au

CRICOS Provider 00002J