Appendix 2: Process Report

The NHMRC was approached by the Australian Commission on Safety and Quality in Health Care (the Commission) in November 2007 to review and update the Infection control guidelines for the prevention of transmission of infectious diseases in the health care setting. These guidelines were produced by the Communicable Diseases Network Australia (CDNA) and released in 2004.

The NHMRC revised guideline (the Guideline) aimed to provide a coordinated approach to the management of health care associated infection (HAI) in Australia by supporting the Commission’s other HAI priority program initiatives including the:

  • National HAI Surveillance Strategy;
  • Hand Hygiene Initiative; and
  • Antibiotic Stewardship.

The NHMRC developed a range of partnerships to support and assist in the guideline development process including the NHMRC’s National Institute of Clinical Studies, CDNA, the Office of Health Protection in the Australian Government Department of Health and Ageing, the Commission and guideline users.

The project plan for the revision of the guidelines was approved by the NHMRC Acting Chief Knowledge Development Officer on 25 January 2008. The Infection Control Guidelines Steering Committee (the Committee) was established under the NHMRC Act (1992) as a Section 39 committee, and was chaired by Dr Ann Koehler, the South Australian representative of the CDNA. The committee was first established with eight members, comprising of experts in microbiology and infectious disease, public health, Indigenous health as well as jurisdictional representatives and infection control professionals. During 2008, two Committee members resigned from the Committee (Ms Dolly Oleson and Ms Claire Boardman) but an additional five members were appointed to broaden the expertise of the Committee. The Committee from November 2008 until the completion of the project is outlined in Appendix 1.

Appointment of technical writers

Ampersand Health Science Writing was selected through a Request for Quote process from the NHMRC Technical Writers and Editors Panel. The two key personnel from Ampersand working on this project were Ms Elizabeth Hall and Ms Jenny Ramson, who participated in the forums and Steering Committee meetings to gain an understanding of the issues and the context of the infection control guidelines.

Scope

The Guideline targets clinicians, ancillary staff and administrators across Australia’s various health care settings. Initial feedback indicated that the following health care settings should be considered when developing the guidelines:

  • private and public acute care;
  • long-term care;
  • community health including home care;
  • remote area health services; and
  • office based practices involved in invasive procedures such as dental, obstetrics and gynaecology, ophthalmology, surgical and general practice.

As a means of addressing this broad scope of practice it was decided that the guidelines would be structured to address the ‘core principles’ of infection prevention and control and the underpinning key practice principles. The core principle of infection prevention and control is to prevent the transmission of infectious organisms and manage infections if they occur. The underpinning key practice principles include:

  1. an understanding of the modes of transmission of infectious agents and an overview of risk management;
  2. effective work practices that minimise the risk of selection and transmission of infectious agents;
  3. governance structures that support the implementation, monitoring and reporting of infection prevention and control work practices; and
  4. compliance with legislation, regulations and standards relevant to infection prevention and control.

It is acknowledged there may be variation in some current practices due to differences in technology, resources and systems supporting a healthcare facility. To address this, a risk-management approach was adopted that considers how factors associated with the transmission of infectious agents can be identified and managed within various health care settings. This approach ensures that common infections such as gastrointestinal viruses and evolving infectious agents such as influenza or antibiotic resistant bacteria can be managed effectively using the principles of infection prevention and control.

Preliminary scoping

The initial focus of the project was to liaise with stakeholders across a broad range of healthcare settings to identify the usefulness and applicability of the 2004 guidelines. This was managed through stakeholder surveys and a series of organised forums. The stakeholder survey was developed to allow participants and the organisations they represented to consider the issues prior to attending the forums. The survey was targeted towards state-based infection control professional associations, public health medical officers and the aged care accreditation alliance. This survey was circulated to stakeholders participating in forums to gather feedback on the guidelines and to organisations wishing to provide feedback but unable to attend the forums.

Stakeholder forums

Stakeholder forums were conducted in Sydney, Canberra and Melbourne in early March 2008, and were facilitated by Carla Cranny and Associates. In all, 59 representatives from various health care settings, the medical device industry, professional associations, health care funders and government agencies attended. The purpose of the forums was to gain feedback from stakeholders in the healthcare setting on the usefulness and applicability of the 2004 guidelines as well as identify gaps and areas of ambiguity in the guidelines.

The forums identified:

  • current gaps in the 2004 guidelines, in particular the need for better guidance on:
    • healthcare worker infection prevention and control issues
    • pandemic planning
    • sterilisation and reprocessing of equipment
    • environmental cleaning and waste management
    • MROs - management of patients in the various health care settings
    • the impact of healthcare facility design on infection prevention and control
    • the scope of practice of infection control professionals and guidance on staffing profiles across the range of service settings;
  • areas of uncertainty or clinical variation in infection prevention and control practice;
  • barriers to implementation of the guidelines including cross references to guidance that is not freely available; healthcare worker attitudes and behaviours and the lack of accountability of health care managers;
  • additional tools required to support implementation; and
  • options on formatting and presentation.

Priority setting

The stakeholder forums identified several key areas the guidelines need to address. These issues relate to: emerging pathogens; screening and clearance of patients with MRO infections; areas where gaps in evidence resulted in variation in clinical practice; and medical device technology.

Using the feedback from the forums, the Committee actively engaged with stakeholders across the healthcare setting to seek feedback on the priority areas the revised infection prevention and control guidelines should address. With significant input from the Australian Infection Control Association, the Committee carefully considered and systematically identified the priority areas of infection prevention and control that need to be addressed by the guidelines. The Committee developed a framework encompassing the broad scope of infection prevention and control activities across the health care setting. Priority areas identified at the forums and by the Committee were placed in the framework and then ranked according to which issues have the greatest impact on infection prevention and control.

From this priority-setting exercise, the Committee identified the key issues that required further research. These issues formed the basis for the development of the clinical questions for systematic review.

Systematic review of the evidence

The recommendations for the Guideline were developed using a twofold approach.

  • For areas where clinical variation exists or it is considered there are emerging issues in infection prevention and control, systematic reviews of the literature were conducted to gather the evidence for the specific guideline section. The NHMRC level and grades pilot program was implemented in reviewing and synthesising the evidence
  • For areas of established practice, recommendations from current national and international guidelines were adapted for an Australian context by the Committee. Guidelines were selected according to their currency and clinical relevance and were appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument to assess the rigor with which they had been developed.

Drafting of clinical questions for systematic review

Dr Adele Weston, a member of the NHMRC evidence-based medicine expert panel, attended the 12 May committee meeting to inform the members on the NHMRC systematic review process including how recommendations are drafted from the evidence. The clinical questions commenced being drafted at that meeting using the population, intervention, comparator, outcome, time (PICOT) approach. They were further refined, circulated and discussed via a series of teleconferences before being released in a Request for Tender in July 2008. The questions are outlined below.

Table App2.1: Clinical questions for systematic review

QUESTION

POPULATION

INTERVENTION

COMPARATOR

OUTCOME

Environmental cleaning

Population

Intervention

Comparator

Outco

  1. Which environmental cleaning/disinfection agents have the greatest efficacy against:

  • Bacteria (specifically MRSA, C. difficile, VRE and Acinetobacter spp

  • Enveloped and non enveloped viruses (specifically blood-borne viruses, rotavirus, norovirus and respiratory viruses).

This information should be presented in a matrix that demonstrates what cleaning agent should be used dependent on what organisms considering its mode of transmission (droplet, contact, respiratory).

Bacteria, non-enveloped and enveloped viruses

Environmental cleaning agent

Alternative environmental cleaning agents and mode of transmission of organisms

Reduced levels of surface agent

  1. Considering the information above, what is the frequency of cleaning required to limit the survival of these organisms considering their survival rates in the environment.

Bacteria, non-enveloped and enveloped viruses

Cleaning agent

Frequency of agent use considering survival rates of the organisms

MROs

Population

Intervention

Comparator

Outcome

  1. What is the most effective method to demonstrate effective decolonisation of MRSA, VRE and MRGNs in patients:

  • previously colonised with the above?

  • currently colonised with the above?

  1. Does this decolonisation reduce the rate of transmission of these pathogens?

Patients with previously MRSA, VRE or MRGN

Patients currently with MRSA, VRE or MRGN

Screening / clearance methods

Other screening / clearance methods

Decolonisation

  1. Does detection of MROs (listed below) through systematic patient screening (and in the case of MRSA with staff) reduce the rate of transmission to other patients:

  • VRE (in high risk areas such as bone marrow transplant ward, ICUs and haemodialysis units)

  • MRSA

  • MRGN

Patients

Staff (in the instance of MRSA)

Screening for MROs

Not screening

Reduced transmission

Transmission outcomes

  1. Does isolation in managing patients with VRE or MRGN reduce the patient’s length of stay / spread of infection to other patients?

Patients

Isolation

Shared bays

Reduced acquisition rates of pathogen in other patients

  1. Does PPE reduce the transmission of MRSA or VRE?

Patients

Gloves, gowns, aprons

No gloves, gowns, PPE

Reduced acquisition rates of MRSA or VRE

Device management

Population

Intervention

Comparator

Outcome

  1. What methods of management have the best efficacy for preventing infection associated with the insertion and maintenance of:

  • Intravascular devices

  • Haemodialysis access devices

Patients

neonates

adults

Device insertion and management

Comparisons of one form of skin antisepsis with others, e.g. alcoholic vs aqueous products including chlorhexidine, povidone iodine, betadine

Reduced post procedural infection

Stick injuries

Population

Intervention

Comparator

Outcome

  1. Is there a decreased incidence of stick injuries for healthcare workers using automated cleaning practices compared to manual cleaning practices?

Healthcare Workers

Automated cleaning

Manual cleaning

Reduced stick injuries

  1. Does the use of retractable devices show a decreased rate in the incidence of sharps injuries for healthcare workers?

Healthcare Workers

Safety devices etc

Non retractable devices

Sharps injuries

Facility design

Population

Intervention

Comparator

Outcome

  1. Can the risk factors for nosocomial infections in healthcare facilities be identified and ranked according to relative risk? Risk factors could include bed occupancy levels, staffing ratios and building design

Healthcare facilities

Bed occupancy levels, staffing ratios and building design Infection control program management

Rates in other facilities, clinical areas

Reduced acquisition rates

  1. Do negative pressure rooms reduce transmission of airborne pathogens to non-infected patients compared to standard rooms? This is inclusive of tuberculosis, multi-resistant tuberculosis, chickenpox/shingles (varicella zoster virus), measles (rubeola) and viral haemorrhagic fevers.

Patients

Isolation in negative pressure room

Normal pressure room isolation

Reduced infection transmission to other patients

  1. Do positive pressure rooms reduce the transmission of infection to immuno-compromised patients compared to normal pressure rooms?

Patients

Isolation in positive pressure room

Single room isolation

Reduced infection rates of immuno-compromised patients

Staff Health

Population

Intervention

Comparator

Outcome

  1. What is the evidence supporting the length of time a healthcare worker should remain excluded from work post the resolution of symptoms of gastroenteritis?

Healthcare Workers

Exclusion period

Different periods of time

Rates of transmission of infection to healthcare worker or patients

Hand hygiene (Level 1 evidence only)

Population

Intervention

Comparator

Outcome

  1. What concentrations of which alcohols are adequate for hand hygiene to decontaminate specific organisms?

Healthcare Workers

Hand hygiene comparing different concentrations of alcohol, and of different alcohols e.g. ethyl, methyl, isopropyl

Washing with water and soap/ detergent/ chlorhexidine,

Other concentrations of same alcohol

Other alcohols

Decontamination of hands

  1. What is the efficacy of alcohol-based products compared to non alcohol-based, e.g. soap and water and other hand-hygiene products, in reducing the risk of transmission of:

  • Clostridium difficile

  • non-enveloped viruses?

Healthcare Workers

Hand hygiene

Non alcohol-based products

Decontamination

Education (Level 1 evidence only)

Population

Intervention

Comparator

Outcome

  1. What is the effectiveness of education program changing healthcare worker behaviour

Healthcare workers

Education programs

Other education programs

Changes in clinician behaviour

The Request for Tender process was ultimately unsuccessful and systematic reviewers were approached using a Request for Quote or Direct Sourcing approach. The systematic reviews were conducted by the following:

Contractor

Topic

Joanna Briggs Institute

  • Effectiveness of environmental cleaning agents

  • Decolonisation of MDRO

  • Patient screening for MDRO

  • Effectiveness of isolation for VRE and MRGN

  • Effectiveness of PPE in reducing VRE and MRSA transmission.

Griffith University

  • Intravascular device management

Royal Darwin Hospital

  • Hand-hygiene products

NHMRC

  • Staff exclusion periods for norovirus

  • Efficacy of positive pressure rooms

  • Efficacy of negative pressure rooms

  • Educational strategies to improve hand-hygiene compliance

A number of clinical questions that were identified as a priority were unable to be conducted due to resource constraints. These included:

  1. Does the use of retractable devices show a decreased rate in the incidence of sharps injuries for healthcare workers?
  2. Is there a decreased incidence of stick injuries for healthcare workers using automated cleaning practices compared to manual cleaning practices?
  3. Can the risk factors for nosocomial infections in healthcare facilities be identified and ranked according to relative risk? Risk factors could include bed occupancy levels, staffing ratios and building design

Due to a paucity of evidence or low quality evidence some systematic reviews were not used to draft recommendations. These include:

effectiveness of environmental cleaning agents;

  • decolonisation of MROs;
  • patient screening for MROs; and
  • efficacy of negative pressure rooms.

Recommendations for these areas were drawn from existing guidelines and supported by expert opinion. The education review to identify strategies to improve hand-hygiene compliance was incorporated into Section C Governance structures, which contains no graded recommendations for practice.

The systematic reviews for:

  • intravascular device management;
  • hand-hygiene products;
  • effectiveness of isolation for VRE and MRGN;
  • effectiveness of PPE in reducing VRE and MRSA transmission;
  • staff exclusion periods for norovirus; and
  • efficacy of positive pressure rooms;

were conducted according to approved NHMRC processes and systematic review methodology with a documented search strategy, inclusion and exclusion criteria, critical appraisal methodology and summary of the evidence. These systematic reviews are provided below. The systematic reviewer summarised the questions and sub questions into the NHMRC template, which documents the evidence base (number of studies, level of evidence and risk of bias in the included studies), consistency, clinical impact, generalisability and applicability.

Systematic review attachments:

The NHMRC template was used by the Steering Committee to draft evidence statements and recommendations corresponding to the summary of evidence provided by the systematic reviewer. These evidence statements and recommendations are summarised below. The grades assigned by the systematic reviewers are documented with the corresponding grades assigned by the Committee. The grades were assigned by the Committee via teleconferences and meetings with the final recommendations and grading also outlined below. Dissenting opinions were noted.

Development of recommendations from guidelines and standards

As a part of the prioritisation process a mapping exercise was conducted to identify relevant guidelines and standards that existed nationally and internationally on infection prevention and control in the health care setting. Links to standards and legislation relevant to infection prevention and control that were identified will be included in Section D: Compliance with legislation and standards. It is envisaged that targeted and public consultation will provide more feedback in this section.

For areas of established practice not covered by the systematic review, guidelines developed using rigorous methodology were used to adapt recommendations from for an Australian context. Guidelines were identified by a combination of literature searches, current use in practice and by the ICG Committee. Guidelines were selected according to their currency and clinical relevance and were appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument to assess the rigor with which they had been developed. The AGREE scores were calculated across the six domains and used to identify which guidelines to use. The NHMRC engaged numerous stakeholders identified during the forums and through the Commission to assist with the appraisal of the guidelines.

Three reviewers per guideline with appropriate clinical experience in infection prevention and control, infectious diseases or guideline development reviewed each guideline. The reviewers included Committee members, the Commissions’ Health Care associated Infection Implementation Advisory Committee and members of the Australian Dental Association.

Reviewers were asked to rate an item on a scale of 1 to 4, with 1 being ‘strongly disagree’ and 4 being ‘strongly agree’. Domain scores were calculated by summing up all the scores of the individual items in a domain and by standardising the total as a percentage of the maximum possible score for that domain. Generally, a higher score indicates the guideline rated well against the AGREE criteria.

The six domains were:

  • scope and purpose;
  • stakeholder involvement;
  • rigour of development;
  • clarity and presentation;
  • applicability; and
  • editorial independence.

An overall assessment and recommendation was provided by each reviewer. Guidelines selected to draft recommendations from were:

  • United States Centre for Disease Control and Prevention (CDC)
    • Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007);
    • Management of Multidrug-Resistant Organisms in Healthcare Settings (2006);
    • Guidelines for infection control in the dental setting (2003);
    • Guidelines for environmental infection control in health-care facilities (2003);
    • Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program (2009)
    • Guidelines for the Prevention of Intravascular Catheter-Related Infections, (2009)
  • Pratt et al (2007) — Epic2: National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England;
  • WHO Guidelines on Hand Hygiene in Health Care (2009);
  • National Institute of Clinical Excellence — Surgical site infection prevention and treatment of surgical site infection (2008);
  • US government website pandemicflu.gov (2006) — Interim Guidance on Planning for the Use of Surgical Masks and Respirators in Health Care Settings during an Influenza Pandemic;
  • Muscedere J et al for the VAP Guidelines Committee and the Canadian Critical Care Trials Group (2008) Comprehensive evidence-based clinical practice guidelines for ventilator-associated pneumonia: Prevention. Journal of Critical Care 23: 126–37;
  • Tenke P, Kovacs B, Bjerklund Johansen TE et al (2008) European and Asian guidelines on management and prevention of catheter-associated urinary tract infections. International Journal of Antimicrobial Agents 31S (2008) S68–S78;
  • NICE (2003) Prevention of Healthcare-associated Infection in Primary and Community Care; and
  • Asterton RG, Galloway A, French G et al (2008) Guidelines for the management of hospital-acquired pneumonia in the UK: Report of the Working Party on Hospital-Acquired Pneumonia of the British Society for Antimicrobial Chemotherapy. J Antimicrobial Chemotherapy 62, 5–34;
  • Nathwani D, Morgan M, Masterton RG, et al. on behalf of the British Society for Antimicrobial Chemotherapy Working Party on Community-Onset MRSA (2008) Guidelines for the UK practice for the diagnosis and management of methicillin-resistant Staphyloccus aureus (MRSA) infections presenting in the community. J Antimicrob Chemother 61: 976–94.

Relevant recommendations were drawn out of each approved guideline and categorised appropriately by the technical writers. These recommendations were circulated to committee members and additional infection prevention and control representatives in topic subgroups, to prioritise what should be used in the guidelines. Comments were collated by the NHMRC and the technical writers and the recommendations chosen for the guideline were refined at a face-to-face meeting. The approach taken to consensus setting was developed in consultation with NICS and comprised attributes of the Delphi and RAND/UCLA processes.

These recommendations were prioritised and then regraded from their original guideline grading to an NHMRC grading based on matching criteria from the original guideline developers. The Committee considered these grades and dissenting comments were noted. The recommendations with their original grading and the assigned NHMRC grading are summarised in Attachment 2c of the full report.

A preliminary draft was provided to jurisdictions for feedback in October 2009. A summary of the feedback and NHMRC responses is provided below.