Guideline development process

From Cancer Guidelines Wiki

Introduction

The issue of medication safety is highly significant when cancer therapies are used as treatment modalities due to the high potential for harm from these medications and the disease context in which they are being used. Success in reducing the incidence of errors is based on the multidisciplinary approach of all the healthcare professionals involved in the prescribing, dispensing and administration of treatment and a strategy that targets multiple stages of the treatment process including the patient and carers.

It was identified that there was a need for a set of guidelines with a proactive approach to safety across the entire process of delivering cancer therapy and in multiple clinical settings of oncology and haematology. The “Clinical Oncological Society of Australia (COSA) guidelines for the safe prescribing, dispensing and administration of cancer chemotherapy” were developed and originally published in 2010.[1][2] A number of international groups have also developed similar guidelines and practice standards.[3][4][5][6]

These guidelines provide an update of the 2010 COSA guidelines and have been developed by a multidisciplinary working group. The update began with a survey inviting COSA members and the wider professional cancer community to comment on the usefulness of the existing guidelines and what information they considered needed to be updated, removed or added. In the revised guidelines, sections on dosage calculation have been expanded for adults and children and issues relating to high risk cancer medications such as vinca alkaloids, etoposide and bortezomib have been included. New sections have been added on complementary and alternative medicines (CAMS), higher risk populations (specifically older adults and paediatrics) and electronic management and prescribing systems. A glossary has now also been included.

The guideline is now presented as 37 clinical questions with consensus based recommendations and practice points. The questions have been organised to initially address the general principles related to the safe provision of cancer therapy, followed by specific sections on the roles of each of the professional groups and the flow of the patient’s care through the prescribing, dispensing and administration of cancer therapy.

Back to top


Purpose

The purpose of these guidelines is to provide recommendations on the safe prescribing, dispensing and administration of cancer therapy including chemotherapy, monoclonal antibodies, targeted therapy and related supportive medicines.

Their aim is to assist in the prevention of medication errors and to improve patient safety with respect to the treatment of cancer. It is intended that these guidelines be used as a tool to inform local practice and be adapted according to service provision, applicability and availability of resources.

Whilst their purpose is to guide clinical practice, these guidelines do not replace clinician judgment. As with all guidelines, they have their limitations and cannot be used in isolation from clinical judgment of the many clinicians involved in the process of providing cancer therapy through prescribing, dispensing and administration.

Back to top

Scope

These guidelines are intended for a multidisciplinary audience and will have most relevance for medical, nursing and pharmacy staff responsible for the complex processes involved in delivering cancer therapy with reference to prescribing, dispensing and administration.

The scope includes:

  • The process of prescribing, dispensing and administration of cancer therapy and supportive medications.
    • The term dispensing is used to encompass the process of the pharmacist’s role in clinical validation, labelling and supply of the therapy.
  • All patients receiving systemic therapy for the treatment of cancer.
    • Cancer medication in the context of these guidelines is defined as a cytotoxic, monoclonal antibody, targeted therapy, immunotherapy and related medicine(s) used to support the delivery of cancer treatment.
    • The term cancer encompasses sub-specialty groups within cancer (i.e. medical oncology and haematology).
  • Delivery in all treatment settings where chemotherapy is prescribed, dispensed and administered (including but not limited to hospital ambulatory care and inpatients) and regardless of location (metropolitan or rural/regional, public or private, home administration etc).
  • All major routes of administration for cancer therapy.


The guidelines do not address:

  • Chemotherapy and monoclonal antibodies used for non-malignant conditions.
  • Workplace health and safety issues that arise from the preparation, administration and disposal of hazardous cancer therapies. Such issues are covered by individual State and Territory Occupational Health and Safety legislation.
  • Standards required for the aseptic manufacturing of parenteral cancer therapy and premises used for manufacture.
  • Detailed and specific requirements for the implementation of electronic information management systems.
  • The roles or responsibilities of non-medical staff in prescribing treatment (i.e. nurse practitioners, pharmacists).

Back to top


Working group members

These guidelines have been developed by a multidisciplinary working group consisting of medical, pharmacy and nursing disciplines. Expert input was also provided by a COSA Project Manager, Cancer Council Australia wiki expert and librarians.

COSA would like to thank all the Working Group Members who contributed their knowledge, skill and time to the development of these guidelines.

Back to top

Steps in preparing clinical practice guidelines

The updated guidelines follow Cancer Council Australia’s guideline development methodology and format for web-based clinical practice guidelines on the wiki platform.[7] The guideline development process which involved conducting literature searches, appraising the literature and formulating recommendations is outlined below:

  1. Define section headings and amendments to 2010 guidelines
  2. Develop a search strategy
  3. Search the literature
  4. Screen and critically appraise the literature
  5. Formulate and grade recommendations
  6. Structure the clinical questions
  7. Write the content
  8. Review of question content

Back to top

Define section headings and amendments to 2010 guidelines

The update began with a survey inviting COSA members and the wider professional cancer community to comment on the relevance and usefulness of the 2010 guidelines, including any sections which needed amendment or changes to the scope. The results of this survey are shown in the Survey Monkey report

The working group reviewed the survey results and agreed on which sections were still relevant and required amending as well as any newly identified sections for the guidelines. The survey identified that more clarity was needed to define the scope of the guidelines which the group also took into account during the revision.

Back to top

Develop a search strategy

The search strategy was developed by experienced librarians with input and advice from the working group. Selection of the search terms was based on review of the existing 2010 guidelines and extensive reading of key papers supplied by the working group plus further references located via several scoping searches.

Free text terms were selected by hand-searching phrases used in relevant documentation (e.g. NSQHS Standard 4: Medication Safety).[8] The baseline search comprised two principal concepts: chemotherapy and medication error/safety. Three additional search strings were created to focus on the prescribing, dispensing, and administering of chemotherapy. This approach ensured each search string captured both the baseline concepts and reflected the responsibility of each role (prescriber, pharmacist and nurse) in mitigating errors in chemotherapy delivery.

Full details of the search terms used are provided in the appendix: Final search strategies

Back to top

Search the literature

A literature search was conducted using systematic review principles to capture appropriate literature pertaining to the safe prescribing, dispensing and administration of cancer therapy. This was conducted by experienced librarians from Austin Health parallel to the process of developing the clinical questions.

The baseline search was created in the MEDLINE database including a combination of Medical Subject Headings (MeSH) and free text words. Databases selected were MEDLINE (indexes Cochrane Database of Systematic Reviews), Embase and PubMed. In light of the pharmaceutical focus of Embase, the pharmacist-specific search strategy was selected for translation from MeSH into Embase Emtree syntax. The search was conducted in January 2016 and repeated in May 2016. The search was not limited by study type, language or date. Search results were exported to a shared EndNote Library. To streamline the review process the references were de-duplicated and sorted into unique result sets according to the three key clinical roles covered in the guideline. A comprehensive cross check was performed by the librarians to ensure that in the creation of unique reviewable result sets no references from the baseline search were lost.

Full details of the search results for each database and term are provided in the appendix: Search strategy results

Subject matter experts within the working group also identified additional grey literature relevant to the guidelines during the scoping and review phases of the project. These additional reference sources included existing standards, webpages/articles and case reports that supported the content of the guidelines.

The 48 references that were cited in the 2010 guidelines were included to cross reference against the new search results. The aim was to establish if evidence used to support the original 2010 guidelines had been replaced by more up-to-date evidence or whether these references were still relevant to the content.

A bridging search was conducted from 16 Feb-16 May 2016 to identify any new literature that may have been published during the content development phase and therefore not captured in the initial search.

Full details of the bridging search results are provided in the appendix: Three month bridging search


Back to top

Screen and critically appraise the literature

Abstracts and titles from the search results were initially screened for relevance and currency according to pre-defined inclusion/exclusion criteria agreed by the working group as follows:

Incl and Excl criteria chemo guidelines.jpg


After the screening process, included articles selected from the literature search were reviewed by the subject matter authors. Each article was critically appraised with respect to level of evidence, quality of the evidence, size of the effect and clinical importance and relevance. Level of evidence was assigned according to the following criteria from the NHMRC Evidence Hierarchy:[9]

Level Intervention Diagnosis Prognosis Aetiology Screening
I A systematic review of level II studies A systematic review of level II studies A systematic review of level II studies A systematic review of level II studies A systematic review of level II studies
II A randomised controlled trial A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among consecutive patients with a defined clinical presentation A prospective cohort study A prospective cohort study A randomised controlled trial
III-1 A pseudo-randomised controlled trial (i.e. alternate allocation or some other method) A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive patients with a defined clinical presentation All or none All or none A pseudo-randomised controlled trial (i.e. alternate allocation or some other method)
III-2 A comparative study with concurrent controls:
  • Non-randomised, experimental trial
  • Cohort study
  • Case-control study
  • Interrupted time series with a control group
A comparison with reference standard that does not meet the criteria required for Level II and III-1 evidence Analysis of prognostic factors among untreated control patients in a randomised controlled trial A retrospective cohort study A comparative study with concurrent controls:
  • Non-randomised, experimental trial
  • Cohort study
  • Case-control study


III-3 A comparative study without concurrent controls:
  • Historical control study
  • Two or more single arm study
  • Interrupted time series without a parallel control group
Diagnostic case-control study A retrospective cohort study A case-control study A comparative study without concurrent controls:
  • Historical control study
  • Two or more single arm study


IV Case series with either post-test or pre-test/post-test outcomes Study of diagnostic yield (no reference standard) Case series, or cohort study of patients at different stages of disease A cross-sectional study Case series

Source: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[9] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)


The flow of information through the different phases of the systematic review and the results are depicted by a PRISMA Flow Diagram [10] This maps out the number of records identified, included and excluded, as well as the reasons for exclusion.


Back to top

Formulate and grade recommendations

The body of literature was assessed by an appraiser assigned according to expertise in the subject matter. Recommendations were formulated using the following criteria adapted from the NHMRC body of evidence matrix.

Component of Recommendation
Recommendation Grade
A
Excellent
B
Good
C
Satisfactory
D
Poor
Volume of evidence 1** one or more level I studies with a low risk of bias or several level II studies with a low risk of bias one or two level II studies with a low risk of bias or a systematic review/several level III studies with a low risk of bias one or two level III studies with a low risk of bias, or level I or II studies with a moderate risk of bias level IV studies, or level I to III studies/systematic reviews with a high risk of bias
Consistency 2** all studies consistent most studies consistent and inconsistency may be explained some inconsistency reflecting genuine uncertainty around clinical question evidence is inconsistent
Clinical impact very large substantial moderate slight or restricted
Generalisability population/s studied in body of evidence are the same as the target population for the guideline population/s studied in the body of evidence are similar to the target population for the guideline population/s studied in body of evidence differ to target population for guideline but it is clinically sensible to apply this evidence to target population3 population/s studied in body of evidence different to target population and hard to judge whether it is sensible to generalise to target population
Applicability directly applicable to Australian healthcare context applicable to Australian healthcare context with few caveats probably applicable to Australian healthcare context with some caveats not applicable to Australian healthcare context
1 Level of evidence determined from level of evidence criteria
2 If there is only one study, rank this component as ‘not applicable’
3 For example results in adults that are clinically sensible to apply children OR psychosocial outcomes for one cancer that may be applicable to patients with another cancer.
** For a recommendation to be graded A or B, the volume and consistency of evidence must also be graded either A or B!

Source: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[9] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)


NHMRC recommendation grades are indicated below:

Grade of recommendation
Description
A
Body of evidence can be trusted to guide practice
B
Body of evidence can be trusted to guide practice in most situations
C
Body of evidence provides some support for recommendation(s) but care should be taken in its application
D
Body of evidence is weak and recommendation must be applied with caution
Consensus-based
recommendation
Recommendations formulated by the guideline development group using a consensus-reaching process.
Practice point
Points of guidance included in the guideline used to support evidence-based recommendations where the subject matter is outside of the scope of the systematic review, and which were formulated based on expert opinion.

Adapted from: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[9] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)

Back to top

Structure the clinical questions

Answerable clinical questions were developed from the section headings and the guideline is now presented as 37 clinical questions.

Clinical questions were structured wherever possible according to the PICO format (Patients/Population/Problem, Intervention, Comparator, Outcome) defined in the Cancer Council Australia’s guideline development methodology and format for web-based clinical practice guidelines on the wiki platform.[7] Due to the focus of these guidelines on processes to maximise safety and minimise harm there was no clear intervention or comparator for some questions.

The order of the questions follow the agreed headings from the 2010 guideline,[1] plus any newly identified sections. The questions have been organised to initially address the issues around general principles and processes related to the safe provision of cancer therapy. These are followed by individual sections with specific questions related to the roles of each of the professional groups and the flow of the patient’s care through the prescribing, dispensing and administration of cancer therapy.

Back to top

Write the content

Each author followed a clear strategy in preparing their guideline content and were designated topics in their areas of expertise, with other working group members contributing as co-authors. Question authors were asked to write the content for their guideline question using the following format:

  • Introduction
  • Evidence summary
  • Recommendations
    • Consensus based recommendations
    • Practice points
  • Associated tables
  • References

Back to top

Review of question content

The chair of the working group reviewed all clinical questions to ensure consistency and clarity of content and language across each section and to minimise any repetition. Each clinical question was also reviewed by the co-author/s and the chair of the working group to produce the final set of recommendations and practice points.

Back to top


References

  1. 1.0 1.1 Carrington C, Stone L, Koczwara B, Searle C, Siderov J, Stevenson B, et al. The Clinical Oncological Society of Australia (COSA) guidelines for the safe prescribing, dispensing and administration of cancer chemotherapy. Asia Pac J Clin Oncol 2010 Sep;6(3):220-37 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20887505.
  2. Carrington C, Stone L, Koczwara B, Searle C. Development of guidelines for the safe prescribing, dispensing and administration of cancer chemotherapy. Asia Pac J Clin Oncol 2010 Sep;6(3):213-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20887504.
  3. Academy of Medical Royal College. Achieving safer prescription of cytotoxic agents: Academy Recommendations 2015. London, UK: Academy of Medical Royal College; 2015 Available from: http://www.aomrc.org.uk/wp-content/uploads/2016/05/Achieving_Safer_Prescription_Cytotoxic_Agents_0415.pdf.
  4. Goldspiel BR, DeChristoforo R, Hoffman JM. Preventing chemotherapy errors: updating guidelines to meet new challenges. Am J Health Syst Pharm 2015 Apr 15;72(8):668-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25825190.
  5. Neuss MN, Gilmore TR, Belderson KM, Billett AL, Conti-Kalchik T, Harvet BE, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology. Oncol Nurs Forum 2017 Jan 6;44(1):31-43 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/28067033.
  6. British Oncology Pharmacy Association (BOPA). Standards for Pharmacy Verification of Prescriptions for Cancer Medicines. [homepage on the internet]; 2013 [cited 2016 Sep]. Available from: www.bopawebsite.org (Members only section).
  7. 7.0 7.1 Clinical Guidelines Network Cancer Council Australia. Development of Clinical Practice Guidelines using Cancer Council Australia’s Cancer Guidelines Wiki. Handbook for section authors and the guideline working party. CCA Sydney; 2014 Available from: http://wiki.cancer.org.au/australiawiki/images/9/9b/CCA_Clinical_Practice_Guideline_Development_Handbook.pdf.
  8. Australian Commission on Safety and Quality in Health Care. Safety and Quality Improvement Guide, Standard 4: Medication Safety. Sydney: ACSQHC; 2012 Available from: http://www.safetyandquality.gov.au/wp-content/uploads/2012/10/Standard4_Oct_2012_WEB.pdf.
  9. 9.0 9.1 9.2 9.3 National Health and Medical Research Council. NHMRC Australian Guidelines to reduce health risks from drinking alcohol. Commonwealth of Australia: National Health and Medical Research Council; 2009 Jan 1 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ds10-alcohol.pdf.
  10. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009 Jul 21;339:b2700 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19622552.

Back to top