SEARCH

SEARCH BY CITATION

Introduction

  1. Top of page
  2. Introduction
  3. Evidence and guidelines
  4. Clinical transfusion practice guidelines in Australasia
  5. Concluding comments
  6. Disclosures
  7. References

Increasingly, clinicians are urged to adopt ‘evidence based practice’. Evidence based medicine (EBM) was widely promoted by Sackett in the UK. He defined EBM as ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients’ [1]. Sackett also indicated that the practice of EBM involves a combination of individual clinical expertise with the best available external clinical evidence from systematic research. In this context, individual clinical expertise means the proficiency and judgement that individual clinicians acquire through clinical experience and clinical practice. Best available evidence comprises clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative and preventive regimens [1]. This evidence based approach essentially combines the art and science of clinical medicine to produce a powerful tool with the capacity to tailor clinical care to meet individual patient requirements and help assure good quality clinical outcomes.

Evidence and guidelines

  1. Top of page
  2. Introduction
  3. Evidence and guidelines
  4. Clinical transfusion practice guidelines in Australasia
  5. Concluding comments
  6. Disclosures
  7. References

In principle all clinicians will be aware of, or have access to, the best available evidence when treating their patients. This perhaps represents the ideal situation. In practice many clinicians whilst supportive of the evidence based approach will prefer the evidence to be distilled into a more user friendly format for every day decision-making. In many environments, the judicious use of evidence based clinical guidelines will meet this requirement. The Oxford English Dictionary defines a guideline as ‘a general rule, principle or piece of advice’. In clinical settings, it is best defined as ‘a document that aims to guide clinical diagnosis and decision-making’. Clinical guidelines have been in place for many years. Initially, they tended to be based on established practice but increasingly during the last two decades guidelines have aimed to use available evidence. Hierarchies of evidence have been developed to support this process by clearly defining the strength and quality of evidence that exists to support a particular guideline statement. Examples of evidence hierarchies, include those produced by the Australian National Health and Medical Research Council (NHMRC) [2] and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system used by the British Committee for Standards in Haematology (BCSH) [3].

The fundamental aim of guidelines is to cause positive changes in clinical practice. In addition to providing a distillation of available evidence they can also provide useful tools for practice review and clinical audit. Good quality guidelines will utilize evidence obtained by systematic retrieval and review of the available evidence. In this way, clinical guidelines provide a bridge between the available evidence base and its application in the clinical environment. Good quality guidelines should identify the level of evidence available to support the statements and recommendations that are made. In this way, guidelines and EBM will be seen as complementary tools to aid good clinical practice rather than as competing approaches. Guidelines will need to be regularly reviewed and updated as new evidence emerges.

Clinical guidelines can also serve a range of other functions. This includes improving consistency or standardization of care potentially including restricted access or ‘rationing’, reducing risk to patients and to achieve the best balance between cost and effectiveness of more expensive interventions.

Blood products are used widely across a range of clinical disciplines. They are used mainly as a supportive treatment rather than as a primary treatment modality. Unfortunately, blood products are often perceived as safe and their use as routine. In this context, few busy practising clinicians will have the time, and possibly inclination, to critically review the available evidence around their safety and efficacy. The development of well-researched evidence based guidelines can potentially be very valuable in this setting. When developing such guidelines it will be important to ensure that the guidelines address the questions that prescribing clinicians might ask. Transfusion practice guidelines can broadly be developed in two ways. Conventionally, the standard approach has been to focus on the blood component itself. This leads to guidelines that aim to address the clinical indications for use of the product. Such guidelines have good utility when looked at from the perspective of the Transfusion Specialist. They support processes that investigate the ‘appropriateness of use’ of the product including audit. Such guidelines have a high utility when used in a stable patient, where the blood product is the mainstay of treatment. It is far less certain that this type of guideline has a high utility for the clinician who will be prescribing the product in a clinically more complex scenario when the blood product is one of many therapeutic modalities that might be appropriate. Increasingly, therefore clinical transfusion guideline development is beginning to focus on clinical scenarios rather than products. This might involve development of guidelines on critical bleeding or in obstetric settings. This approach supports a more considered assessment of the use of transfusion alternatives and can also evaluate the extent to which primary treatment decisions (e.g. type of anaesthetic or surgical technique) might influence the likelihood of transfusion being required. This scenario based approach ultimately leads to the developing concept of ‘patient blood management’.

Careful consideration also needs to be given to who ‘owns’ the guidelines. This applies to both product and scenario based guidelines. Broad clinical speciality involvement will likely improve both the utility and acceptance of guidelines.

Clinical transfusion practice guidelines in Australasia

  1. Top of page
  2. Introduction
  3. Evidence and guidelines
  4. Clinical transfusion practice guidelines in Australasia
  5. Concluding comments
  6. Disclosures
  7. References

In 2001, the Australian and New Zealand Society for Blood Transfusion (ANZSBT formerly ASBT), worked collaboratively with the Australian NHMRC to develop a series of evidence based guidelines on the Clinical use of Blood Components [4]. These guidelines were widely promoted across clinical services in both Australia and New Zealand. The primary stimulus to development of the guidelines was concern relating to the increasing demand for blood components and a belief, based on results of clinical audit, that there was significant evidence of inappropriate use. The working party responsible for development of the guidelines was comprised predominantly of haematologists and transfusion scientists utilizing an approach based on the NHMRC Guidelines for the Development and Implementation of Clinical Practice Guidelines. This includes a comprehensive literature review. In addition to the guidelines themselves the outputs of the process included a series of posters, pocket-sized summaries of indications for each blood component and patient information leaflets to support the process of gaining informed consent. Copies of all of these documents are freely available on the ANZSBT website [5]. The working group also developed a set of ‘organizational recommendations’ that aimed to support the implementation of guidelines and monitoring of their effectiveness. The guidelines undeniably raised awareness of transfusion practice across the health sector and contributed to the establishment of a range of organizational initiatives to improve clinical practice in this area. The impact on improving the level of compliance with the guidelines (i.e. reducing inappropriate use) is however less clear.

In 2007, a decision was made to undertake a review of the guidelines. This review was initiated by the Australian National Blood Authority (NBA) who provides secretariat support to the ANZSBT and NHMRC who continue to be responsible for the process. The aim of the review is to provide a series of six comprehensive, evidence based, patient-focussed blood management guidelines. These will be developed in three phases. The first resulting in the development of perioperative and critical bleeding guidelines, the second focussing on medical conditions and critical care and the third on obstetric and paediatric/neonatal guidelines. The organizational structure for the review process is also fundamentally different from that used in the original process. A steering group has been established with overall responsibility for the management of the process. An expert working group (EWG) is also in place. The EWG is responsible for defining the scope and co-ordinating clinical input from a number of clinical and consumer reference groups (CRG), which will provide valuable clinical expertise on specific clinical elements of the guidelines. The membership of both the EWG and CRG is based on nominations from a wide range of Professional Colleges and Specialty Societies. This approach aims to improve ownership and relevance of the final guidelines. Consultants have also been commissioned to undertake the systematic review and technical writing services needed for the project. Further information on the processes used and current status of the project can be found on the National Blood Authority website [6].

Significant progress has been made during the last few years. Systematic reviews for the first phase of the guideline have now been completed. Draft guidelines on critical bleeding were published for consultation in April 2010. A final version of the guidelines is anticipated in early 2011. Consultation on the perioperative guidelines commenced in February 2011.

The Critical Bleeding guideline demonstrates the format for the range of guidelines that will be developed. This involves an assessment of the literature linked to preagreed questions with the subsequent identification of evidence statements. These evidence statements were then used to develop a series of ‘action-orientated’recommendations and practice points. Recommendations were only developed, where the body of evidence supported this within the rules of the hierarchy of evidence used by the NHMRC. The wording of the recommendations reflects the strength of the body of evidence supporting the recommendation. Practice points were developed in settings, where the Clinical Reference Group considered guidance would benefit effective patient care but where there was insufficient evidence to support the development of a recommendation. A consensus approach was used for the production of the practice points.

Concluding comments

  1. Top of page
  2. Introduction
  3. Evidence and guidelines
  4. Clinical transfusion practice guidelines in Australasia
  5. Concluding comments
  6. Disclosures
  7. References

The development of the clinical practice guidelines in Australia and New Zealand is a ‘work in progress’ initiative. It is too early to say whether the overall approach will be successful in changing clinical practice. Overall, however, the approaches being used in the process ably demonstrate the way in which systematic reviews of evidence can be used to support the development of evidence based clinical guidelines. This suggests that evidence and guidelines should be seen as complimentary rather than competing mechanisms for driving good clinical practice. Evidence will of course continue to evolve as the results of new studies emerge. Regular review of clinical guidelines will therefore be required to ensure that they remain current.

References

  1. Top of page
  2. Introduction
  3. Evidence and guidelines
  4. Clinical transfusion practice guidelines in Australasia
  5. Concluding comments
  6. Disclosures
  7. References