Prioritisation of National Clinical Guidelines Consultation Submission Report 25th March 2015 1 Table of Contents 1. National Clinical Effectiveness Committee ................................................................................................ 3 2. Introduction to prioritisation consultation................................................................................................ 3 3. Themes arising and NCEC responses ......................................................................................................... 5 Theme 1 Clarity and readability of document Theme 2 Capacity of NCEC and the health system Theme 3 Transparency of reviewers Theme 4 Prioritisation criteria and weighting of criteria Theme 5 Specific inclusions Appendix 1 Issues raised beyond the scope of the consultation ...................................................................... 8 2 1. National Clinical Effectiveness Committee The National Clinical Effectiveness Committee (NCEC) is a Ministerial committee established as part of the Patient Safety First Initiative. The NCEC role is to prioritise and quality assure National Clinical Guidelines and National Clinical Audit so as to recommend them to the Minister for Health to become part of a suite of National Clinical Guidelines and National Clinical Audit. NCEC Terms of Reference: - - Apply criteria for the prioritisation of clinical guidelines and audit for the Irish health system Apply criteria for quality assurance of clinical guidelines and audit for the Irish health system Disseminate a template on how a clinical guideline and audit should be structured, how audit will be linked to the clinical guideline and how and with what methodology it should be pursued Recommend clinical guidelines and national audit, which have been quality assured against these criteria, for Ministerial endorsement within the Irish health system Facilitate with other agencies the dissemination of endorsed clinical guidelines and audit outcomes to front-line staff and to the public in an appropriate format Report periodically on the implementation of endorsed clinical guidelines. Information on the NCEC and endorsed National Clinical Guidelines is available at: www.health.gov.ie/patient-safety/ncec 2. Introduction to prioritisation consultation The National Clinical Effectiveness Committee (NCEC) in 2014 gave consideration to prioritisation processes that could assist the identification of key areas for potential National Clinical Guidelines in the Irish healthcare system that best address the healthcare needs of the Irish population. The development of the NCEC prioritisation process was informed by international literature, Irish requirements and NCEC members’ considerations. The NCEC agreed to include a weighting process for prioritisation criteria and the commissioned guideline process. The NCEC launched a public consultation on its proposed guideline prioritisation process on 28/1/2015, closing on 20/2/2015. This consultation was placed on the Department of Health website and circulated to key stakeholders via the NCEC committee and directly to the HSE Quality Improvement Division and the HSE Clinical Programmes Division. A number of twitter notices were also circulated. Sixteen responses were received – see Table 1. Respondents were asked to consider three questions in relation to the proposed new National Clinical Guideline prioritisation process. 1. Feedback in relation to the proposed prioritisation streams 2. Feedback in relation to the proposed prioritisation criteria 3. Any general or specific feedback on the document 3 This report details the main themes that arose in the consultation submissions. Individual responses are not identifiable in the report. Specific minor issues, such as typographical errors, suggested changes in terms or formatting are not included in this report but have been considered in adapting the document. In addition to commenting on the Prioritisation Consultation document, some submitters used the opportunity to highlight other issues. While this feedback was beyond the scope of the consultation and is not included in detail in this report it will where appropriate be considered in other NCEC deliberations. Appendix 1 provides a summary related to these issues. Table 1 Responses to NCEC Public Consultation – Prioritisation of National Clinical Guidelines Advanced Nurse Practitioner Advisor to National Emergency Medicine Programme Department of Nursing and Midwifery, University of Limerick Dublin City University, School of Nursing and Human Sciences Health Sciences Libraries Group Committee HSE Clinical Programme for Obstetrics and Gynaecology Irish Heart Foundation Irish Medical Organisation Joint Chair Clinical Nursing UCD, Mater Misericordiae University Hospital and St Vincent’s University Hospital Medicinal Product Prescribing Team, Office of Nursing and Midwifery Services, HSE Mental Health Commission National Cancer Control Programme (NCCP) NMPD Team West Midwest Pharmaceutical Society of Ireland School of Nursing and Midwifery, NUI Galway School of Nursing and Midwifery, University College Cork Specialty National Quality Improvement Programmes in Histopathology, GI Endoscopy and Radiology managed by RCPI In the main, submitters welcomed the opportunity to respond to the consultation and were positive about the document and its ability to aid a variety of collaborative approaches to guideline development. It was suggested that the NCEC should consider obtaining a plain English mark if this document is to be made available to the public. 4 3. Themes arising and NCEC responses Five main themes emerged as follows: - Theme 1 Clarity and readability of document Theme 2 Capacity of NCEC and the health system Theme 3 Transparency of reviewers Theme 4 Prioritisation criteria and weighting of criteria Theme 5 Specific inclusions. Theme 1 Clarity and readability of document (A) The scope of the document should be emphasised. RESPONSE: A statement will be included that this prioritisation process applies to National Clinical Guidelines only and not National Clinical Audit. A statement emphasising that National Clinical Guidelines can act as the basis for key quality metrics of healthcare will be added. (B) Greater clarity in relation to some of the terminology used in the document. RESPONSE: A glossary will be included. (C) Further detail is required in relation to some of the processes, for example: ‘executive support’ - Clearer indication of the degree, extent and type of support or guidance available under each stream for prospective guideline proposers would be helpful. ‘commissioning’ - An outline of the commissioning process ‘notice of intent’ - With whom does the responsibility for managing this rest? How is this managed to ensure that the various stakeholders combine their efforts to produce one piece of guidance. ‘appeals mechanism’ on prioritisation decision. RESPONSE: Further detail will be added to description of NCEC processes. The NCEC has published a Framework of Endorsement of National Clinical Guidelines which outlines its processes and provides information with regard to appeals. This is available at: http://health.gov.ie/wp-content/uploads/2015/01/Framework-for-Establishment-of-NationalClinical-Guidelines-July-2014-1.pdf Theme 2 Capacity of NCEC and the health system The equality of the streams was raised in relation to the capacity to deliver by the health system and NCEC. For example, if there are already four commissioned guidelines (seen as ambitious due to need to implement and update, n=1) in process and another guideline warrants inclusion from Stream 2 or 3; is there a ceiling on the number of guidelines that NCEC will accept for submission from stream 2 and can a respective clinical programme veto a guideline proposed through stream 3? It was suggested that a worked example would aid a full understanding of the processes. 5 RESPONSE: Guidelines submitted to NCEC to date have emerged through the three identified streams. The prioritisation process aims to provide a transparent framework to manage the three streams in order to provide for the identification of and subsequent support for the most important National Clinical Guidelines. This needs to take into consideration the capacity of the health system for implementation of National Clinical Guidelines. The NCEC recognises that prioritisation exercises by their nature must also incorporate the more nuanced and subjective discussions that arise from applying a prioritisation process and these considerations will also contribute to the final decision around which guidelines/topics are to progress to a National Clinical Guideline. The NCEC prioritisation process will be reviewed by NCEC on an annual basis to examine its effectiveness and will be updated as necessary. When available having gained experience of the prioritisation process NCEC will describe worked examples as appropriate. Theme 3 Transparency of reviewers Greater transparency on the criteria to be used for the selection of specific reviewers for the prioritisation process including the optimum number of reviewers needed to ensure reliability; the amount, if any, of independent blind review within the process; the mix of internal and external reviewers should be provided. The management of conflict of interest within the review was suggested by 3 respondents RESPONSE: The NCEC has published a Framework of Endorsement of National Clinical Guidelines which outlines its processes and more detail and specific information related to issues raised in the theme above: This is available at: http://health.gov.ie/wp-content/uploads/2015/01/Frameworkfor-Establishment-of-National-Clinical-Guidelines-July-2014-1.pdf Theme 4 Prioritisation criteria and weighting of criteria Whilst acknowledging the importance of weighting to ensure consistency and objectivity, two submitters asked if the prioritisation criteria had been tested for validity and reliability and used in other jurisdictions. The process of applying the weighting was also questioned. For example, was the weighting process anonymised; how consensus is reached from the many different stakeholder perspectives? One submitter asked for greater explanation to aid comprehension and another suggested a practical working example from a completed / partially completed weighting might be useful to enhance understanding of how this step might be realised. Regarding the criteria for weighting, a number of submitters were apprehensive that economic aspects would be the primary concern (n=2). Others argued that patient safety and potential for improved health should be prioritised before other criteria and weighted accordingly. Another suggested that the prioritisation process should emphasise factors related to care, safety, quality, dignity, patient-centeredness, equity and keeping people healthy. Criteria 7 related to guideline implementation raised comments regarding expansion of the criterion to include evaluation and updating and difficulty due to barriers to implementation presenting at various points and from a variety of sources in the implementation process. Other suggestions on weighting included: an additional criterion of service user preference. a reframing of the criteria descriptors from a question format to an indicator format. the tone of the patient safety descriptor to reflect a more prospective approach. 6 Other feedback of the scoring system was the lack of a specific score for a guideline to be prioritised by the NCEC nor if failure on a particular criteria will lead to exclusion. If two or more guidelines are scored equally then priority should be given to the guideline that scores highest on certain criteria e.g. patient safety. RESPONSE: The development of the NCEC prioritisation process was informed by international literature, Irish requirements, NCEC members’ considerations and a public consultation. The inclusion of a weighting process for prioritisation criteria was to support balance in terms of the weighting of the criteria. The NCEC comprises a broad group of stakeholders and will continue to review its processes on an annual basis to examine its effectiveness and will update processes as necessary. The patient safety descriptors in the patient safety criterion have been updated. Theme 5 Specific inclusions - Addition to Page 3, Paragraph 2: Introduction to National Clinical Guidelines. Addition to list under heading “A rigorous methodological....” A systematic clinical literature review using recommended resources and/or healthcare librarian support is completed to underpin guideline recommendations. The systematic literature review is transparent - Guidelines for systematic literature searching using recommended resources, with reference to Cochrane, CRD and PRISMA protocols. - Criteria 5 Variability in Practice Topics for Clinical Guidelines are often selected because they are important to large numbers of people with substantial morbidity or mortality and where evidence of variation in care exists. Classical quality assurance seeks to remove variation in care both below and above the standard chosen. Clinicians providing excellent care should not be required to deliver a lower standard of care. - Criteria 7 Clinical Guideline Implementation Clinicians must be engaged in the development and implementation of clinical guidelines. Frontline clinicians who have knowledge of effectiveness should be explicitly represented in the development of clinical guidelines. They should have appropriate clinical experience and should enjoy the confidence of their peer colleagues. Similarly patient representative organisations involved in guideline development should be appropriate to the topic and bring practical experience to the table. RESPONSE: Further detail will be added to descriptions. The NCEC has published two documents which provide more detail and specific information related to issues raised in the theme above: Framework of Endorsement of National Clinical Guidelines and Guideline Developer’s Manual. These are available at: http://health.gov.ie/patientsafety/ncec/resources-and-learning/ncec-processes-and-templates/ 7 Appendix 1 Issues raised beyond the scope of the consultation NCEC processes Patient involvement in NCEC processes (n=2). Broadening NCEC terms of reference regarding support for clinical guidelines. A list of recommended resources for systematic reviews be developed which includes the following minimum core set in addition to other subject specific resources and international grey literature sources relevant to the guideline topic: - PubMed/Medline (free and subscribed) - Embase (subscribed) - Cochrane Library & Central Register of Controlled Trials (national access provided) - Web of Science (subscribed). Clinical topics for prioritisation Some submissions took the opportunity to highlight the reason why their speciality should be prioritised for a National Clinical Guideline. General comments about National Clinical Guidelines One submission detailed a rationale for, in certain circumstances, non-adherence to or, in general, modification of National Clinical Guidelines. This included: - Patients’ needs and preferences can differ vastly - Professional and ethical requirements of professional regulatory bodies may override the clinical guideline - Clinical response that shows the guideline to be ineffective in the particular individual clinical circumstances - Through CPD/CME, practitioners are more up to date than formally quality assured systematic reviews of evidence - Strict adherence to clinical guidelines may stifle innovation and the advance of medical science and that failure to adhere to a clinical guideline, when acting in the best interests of a patient should not be grounds for a complaint to the Medical Council or litigation against a healthcare professional. 8
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