NATIONAL CLINICAL EFFECTI ENESS COMMITTEE. National Clinical Effectiveness Committee Standards for Clinical Practice Guidance

Transcription

1 NATIONAL CLINICAL EFFECTI ENESS COMMITTEE National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance Novembe 2015

2 Table of Contents Glossay of Tems 2 1. Pupose 4 2. Scope 5 3. Monitoing and Implementation 6 4. Expet advisoy goup 7 5. National Clinical Effectiveness Committee 8 6. Standads fo Clinical Pactice Guidance ationale Development of Clinical Pactice Guidance 12 Refeences 17 Appendix A Systematic liteatue eview 19 Appendix B Intenational esouces 21 Appendix C Building a Cultue of Patient Safety 22 Appendix D Definitions/nomenclatue

3 2 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee Glossay of Tems Clinical Pactice Guidance Clinical Guideline NCEC National Clinical Guideline Clinical Pactice Guidance is defined as systematically developed statements o pocesses to assist clinician and patient decisions about appopiate health cae fo specific clinical cicumstances, with the type of clinical pactice guidance detemined by evidence-based citeia and clinical equiements. Such clinical guidance includes clinical policies, pocedues, potocols and guidelines. Clinical Guidelines ae systematically developed statements, based on a thoough evaluation of the evidence, to assist pactitione and patient decisions about appopiate health cae fo specific clinical cicumstances, acoss the entie clinical spectum. NCEC National Clinical Guidelines ae a suite of guidelines that meet specific pioitisation and quality assuance citeia and that have been ecommended by the National Clinical Effectiveness Committee (NCEC). Once a National Clinical Guideline is endosed it supesedes any othe guidelines on that topic. Clinical Audit NCEC National Clinical Audit Clinical Audit is a cyclical pocess that aims to impove patient cae and outcomes by systematic, stuctued eview and evaluation of clinical cae against explicit clinical standads. 1 NCEC National Clinical Audits ae national audits which have been pioitised and quality assued by the National Clinical Effectiveness Committee (NCEC). Clinical Policy Clinical Pocedue Clinical Potocol Clinical Decision Suppot Cae Bundle Cae Pathway Flowchat A Clinical Policy is a witten opeational statement of intent which helps staff to make appopiate decisions and take actions, consistent with the aims of the sevice povide and in the best inteests of sevice uses. A Pocedue is a witten set of instuctions that descibes the appoved and ecommended steps fo a paticula act o sequence of events. A Clinical Potocol is an ageed statement about a specific clinical issue, with a pecise sequence of activities to be adheed to, with little scope fo vaiation. Clinical Potocols ae usually based on guidelines and/o oganisational consensus. Clinical Decision Suppot efes to the povision of clinical knowledge and patient specific infomation to help clinicians and patients make decisions that enhance patient cae. A Cae Bundle is a stuctued way of impoving the pocesses of cae and patient outcomes: a small, staightfowad set of evidence-based pactices geneally thee to five that, when pefomed collectively and eliably, have been poven to impove patient outcomes. A Cae Pathway is a multidisciplinay cae plan that outlines the main clinical inteventions that ae caied out by diffeent healthcae pactitiones fo sevice uses with a specific condition o set of symptoms. They ae usually locally ageed, evidence-based plans that can incopoate local and national guidelines into eveyday pactice. A Flowchat is a diagam of the sequence of movements o actions of people o things involved in a complex system o activity. 1 This definition will be aligned to the fothcoming Health Infomation and Patient Safety Bill.

4 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 3 Algoithm Checklist Model of cae Algoithms povide evidence-based step-by-step visual intepetation of the decision making and/o associated actions elating to a paticula guidance aea. Notably the steps within an algoithm ae moe naowly defined than in a guideline. A Checklist is a tool that condenses a lage volume of infomation and allows fo systematic veification of steps o pactices. A Model of Cae is a multifaceted concept, which boadly defines the way health sevices ae deliveed. A model of cae outlines best pactice patient cae delivey though the application of a set of sevice pinciples acoss identified clinical steams and patient flow continuums. The boad objective of developing a model of cae is ensuing people get the ight cae, at the ight time, by the ight team and in the ight place. Clinician Standad A Clinician is a health pofessional involved in clinical pactice. A Standad is a definable measue against which existing stuctues, pocesses o outcomes can be compaed. Aconyms CEU CHO CMO CPG DoH DoHC HIQA HR HSE HTA IT MHC NCEC PPPG Clinical Effectiveness Unit. Community Health Office. Chief Medical Office. Clinical Pactice Guidance. Depatment of Health. Depatment of Health and Childen. Health Infomation and Quality Authoity. Human Resouces. Health Sevice Executive. Health Technology Assessment. Infomation Technology. Mental Health Commission. National Clinical Effectiveness Committee. Policies, Pocedues, Potocols and Guidelines. See Appendix D fo a summay of definitions/nomenclatue cuently in use.

5 4 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee 1 Pupose of this Standads fo Clinical Pactice Guidance document The pupose of this document is to povide standads fo healthcae staff developing evidencebased clinical pactice guidance fo health cae. What is Clinical Pactice Guidance? Clinical pactice guidance is defined as systematically developed statements o pocesses to assist clinician and patient decisions about appopiate health cae fo specific clinical cicumstances, with the type of clinical pactice guidance detemined by evidence-based citeia and clinical equiements. Such clinical guidance includes clinical policies, pocedues, potocols and guidelines. Cae pathways, clinical decision aids/tools, cae bundles, flowchats, checklists and algoithms can fom components of policies, pocedues, potocols o guidelines. Does Clinical Pactice Guidance impove patient cae? Clinical effectiveness is a key component of patient safety and quality. The integation of best evidence in sevice povision, though clinical effectiveness pocesses such as clinical pactice guidance, pomotes healthcae that is up to date, effective and consistent. The vision of the Standads fo Clinical Pactice Guidance is quality impovement fo patient safety. The added value of standads fo clinical pactice guidance fo policy, health system, public and patients can include: Impoving and optimising patient outcomes Evidence-based pactice Standadisation of appoach to avoid duplication Facilitation of audit: povides paametes fo audit Reduction of vaiation in clinical pactice Consistency of nomenclatue Impovement of methodological igou. Why do we need Standads fo Clinical Pactice Guidance? In clinical pactice, thee ae diffeent types of guidance that vay in complexity and scope. Fo example, guidance can be a compehensive oveaching National Clinical Guideline o a moe specific clinical potocol. Regadless of the vaiation in scope and focus, it is impotant that the development of all clinical guidance is undepinned by coe standads using an evidencebased appoach, to assist clinician and patient decisions about appopiate healthcae fo specific clinical cicumstances. Though consistency in appoach and eduction in duplication, vaiation in pactice can be educed. Shaing of best pactice will optimise use of health sevice esouces and expetise. NCEC appoach to development of standads The standads wee developed by the NCEC, infomed by a systematic liteatue eview, advice fom an Expet Advisoy Goup and feedback fom a public consultation pocess. Aim: to publish standads fo clinical pactice guidance fo healthcae povides. Objectives: Publish standads which will povide a standadised nomenclatue and methodology fo the development of evidence-based clinical pactice guidance nationally. Ensue consistency of appoach and minimise duplication in clinical pactice guidance.

6 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 5 2 Scope The Scope of the Standads fo Clinical Pactice Guidance includes Clinical Pactice Guidance in healthcae, spanning the full multidisciplinay team. This includes all healthcae povides in the Republic of Ieland. The standads ae applicable to healthcae in all settings e.g. acute cae, social cae, mental health, cae of the eldely, pimay cae, disabilities. Scope of the Standads fo Clinical Pactice Guidance All healthcae settings Clinical policies Clinical pocedues Clinical potocols Clinical guidelines The following can fom components of policies / pocedues / potocols / guidelines: Cae pathways, clinical decision aids/tools, cae bundles, flowchats (Oganisation of cae; to suppot systems of cae) Checklists, algoithms (Implementation) The Standads fo Clinical Pactice Guidance include clinical policies, pocedues, potocols and guidelines. Cae bundles, cae pathways and clinical decision aids can fom pat of the appoach to oganisation of cae fo clinical guidance. Checklists and algoithms can fom pat of the guidance implementation toolbox. These ae included as components of policies, pocedues, potocols and guidelines athe than stand-alone clinical pactice guidance. Models of cae, as descibed by the HSE Clinical Stategy and Pogammes Division (Appendix D), will also be infomed by the standads. Thee ae existing egulatoy famewoks which encompass equiements in elation to the development, implementation and monitoing stages of clinical pactice guidance, such as the National Standads fo Safe Bette Healthcae (HIQA, 2012) and the Quality Famewok fo Mental Health Sevices (MHC, 2007). The Standads fo Clinical Pactice Guidance ae intended to suppot and complement these existing pocesses. It is expected that the HSE and all oganisations will develop all new and updated guidance in line with these standads. Whee clinical pactice guidance is aleady in place, a plan to eview this guidance should be made, with key patient safety aeas pioitised. Review of existing guidance is ecommended evey 3 yeas, o soone if equied by law o new evidence, audit o infomation indicates equied change. Outside scope The Standads fo Clinical Pactice Guidance ae applicable to healthcae pocesses which assist clinician and patient decisions about appopiate healthcae fo specific clinical cicumstances. These standads ae not intended to cove opeational o non-clinical pocesses e.g. specimen tanspot, clinical waste management, HR policies etc. In exceptional cicumstances, whee inteim clinical guidance is equied on an emegency basis (e.g. public health emegencies, hazads and emeging infectious theats such as Ebola vius), this guidance should be developed by expets, based on the best available evidence. If sustained as guidance following the initial emegency, this inteim guidance can be futhe developed using the standads.

7 6 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee 3 Monitoing and Implementation Oganisations should put pocesses in place to implement and monito these standads. Fomal govenance aangements fo clinical pactice guidance at local, egional and national level should be established and documented by healthcae povides. This govenance pocess should clealy outline quality assuance mechanisms, specific oles and esponsibilities, accountability and authoity. Clea pocesses fo developing, appoving, disseminating, implementing, monitoing, auditing and updating clinical pactice guidance within the oganisation needs to be clealy outlined and available fo staff. The Health Sevice Executive has established a National PPPG Steeing Goup fo policies, pocedues, potocols and guidelines (PPPG) to develop a famewok that will clealy define the pocess fo the use and implementation of the NCEC Standads fo Clinical Pactice Guidance. A govenance pocess, standad template, staff taining and national epositoy fo HSE CPGs is also planned by the HSE. The Standads fo Clinical Pactice Guidance povide a famewok fo assessment and audit. It is expected that the health system egulatos will assess the copoate assuance aangements in place to ensue effective implementation of these standads.

8 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 7 4 Expet advisoy goup An expet advisoy goup was established to povide advice and infomation to the NCEC in the development of the standads. The membes of this goup ae listed below. Oganisation / Division (nominated by) Clinical Effectiveness Unit, Depatment of Health HSE Quality Impovement Division (D Philip Cowley) HSE Mental Health Division (Ms Anne O Conno) HSE Quality Assuance Veification (QAV) Division (M Patick Lynch) Independent Hospital Association of Ieland (Ms Catheine Whelan) HSE Social Cae Division (M Pat Healy) HSE Clinical Stategy and Pogammes Division (D Áine Caoll) HSE Acute Hospitals Division (M Liam Woods) HSE Pimay Cae Division (M John Hennessy) Nominee D Niamh O Rouke (Chai) Ms Bid Boyce Ms Magaet Bennan D Edwina Dunne D Stephen Fohlich D Siobhan Kennelly Ms Aveen Muay Ms Deide O Keeffe Ms Viginia Pye

9 8 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee 5 National Clinical Effectiveness Committee The National Clinical Effectiveness Committee (NCEC) is a Ministeial committee established by the Depatment of Health as pat of the Patient Safety Fist Initiative to povide ovesight fo the national clinical effectiveness agenda which includes National Clinical Guidelines, National Clinical Audit and Clinical Pactice Guidance. Membeship of the committee is multidisciplinay and includes epesentatives fom: the Health Infomation and Quality Authoity, Mental Health Commission, Health and Social Cae Regulatoy Foum, Health Poducts Regulatoy Authoity, State Claims Agency, Foum of Postgaduate Taining Bodies, Nusing and Midwifey Education Bodies, Foum of Hospital Goup CEOs, HSE Clinical Pogammes, HSE Quality Impovement Division, HSE Office of Nusing and Midwifey Sevices, National Office fo Clinical Audit, Independent Hospital Association of Ieland, Depatment of Health, Health Insuance Council, Health Reseach Boad and two patient epesentatives. The NCEC Tems of Refeence ae to: 1. Povide stategic leadeship fo the national clinical effectiveness agenda. 2. Contibute to national patient safety and quality impovement agendas. 3. Publish Standads fo Clinical Pactice Guidance. 4. Publish guidance fo National Clinical Guidelines and National Clinical Audit. 5. Pioitise and quality-assue National Clinical Guidelines and National Clinical Audit. 6. Commission National Clinical Guidelines and National Clinical Audit. 7. Align National Clinical Guidelines and National Clinical Audit with implementation leves. 8. Repot peiodically on the implementation and impact of National Clinical Guidelines and the pefomance of National Clinical Audit. 9. Establish sub-committees fo NCEC wok-steams. 10. Publish an Annual Repot. The NCEC famewok is outlined in Figue 1 below. Futhe infomation on the NCEC famewok and NCEC documentation including endosement and quality assuance citeia fo National Clinical Guidelines and National Clinical Audit is available at: ncec National Clinical Effectiveness Committee (NCEC) Patient Safety Fist Initiative Ministeial committee (Suppoted by the Clinical Effectiveness Unit) Suite National Clinical Guidelines Suite National Clinical Audit Standads Clinical Pactice Guidance Figue 1: NCEC famewok

10 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 9 Clinical Effectiveness Pocesses Clinical effectiveness is a key component of patient safety and quality. The integation of best evidence in sevice povision, though clinical effectiveness pocesses, pomotes healthcae that is up to date, effective and consistent. Clinical effectiveness pocesses include guidelines, audit and clinical pactice guidance. This wok emanates fom a equest by the Ministe fo Health that NCEC would develop standads fo clinical pactice guidance following the Repot of the CMO into Potlaoise Peinatal Deaths (2014) as outlined in the box below. The development of Standads fo Clinical Pactice Guidance builds on existing famewoks such as Safe Bette Healthcae (HIQA 2012), Building a Cultue of Patient Safety (DoHC 2008) and the Quality Famewok fo Mental Health Sevices (MHC 2007). Clinical Effectiveness Recommendation R.19 The National Clinical Effectiveness Committee should develop standads fo clinical pactice guidance. Responsible body NCEC Standad definitions and citeia should be developed in elation to the vaious foms of clinical pactice guidance such as guidelines, checklists, pocedues, clinical guidance, clinical potocols etc. This will ensue consistency of appoach and utilisation of appopiate methodology to develop clinical pactice guidance nationally. National context The Health Infomation and Quality Authoity developed National Standads fo Safe Bette Healthcae in 2012 to descibe what a high quality, safe sevice looks like. These standads ae an impotant dive fo the implementation of clinical guidance as they set out the need fo clinical decisions to be based on best available evidence and infomation; to dive impovements in the quality and safety of healthcae it is impotant that decisions, including clinical decisions, ae based on the best available evidence and infomation. The epot of the Commission on Patient Safety and Quality Assuance, Building a Cultue of Patient Safety (DoHC 2008) and the Quality Famewok fo Mental Health Sevices (MHC 2007) also ecommend the development of evidence-based standads. It is impotant that the NCEC Standads fo Clinical Pactice Guidance ae aligned with othe national standads, initiatives and leves fo implementation. The HSE wok on PPPGs will complement and suppot the implementation of the NCEC Standads fo Clinical Pactice Guidance though a shaed vision fo evidence-based pactice that educes vaiation and duplication in clinical pactice.

11 10 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee The existing egulatoy and policy famewoks encompass the development, implementation and monitoing stages of clinical pactice guidance and ae summaised in the box below: National Standads fo Safe Bette Healthcae (HIQA, 2012) Standad 2.1. Healthcae eflects national and intenational evidence of what is known to achieve best outcomes fo sevice uses Healthcae that is deliveed accoding to policies, guidelines, potocols and cae pathways that ae based on best available evidence Use of National Clinical Guidelines and nationally ageed potocols, cae bundles and cae pathways whee available An evidence-based pocess fo the development of policies, guidelines, potocols and cae pathways Suppot fo and facilitation of, the wokfoce in making decisions based on the best available evidence Suppot fo healthcae pofessionals in making clinical decisions based on evidence which will maximise benefits to sevice uses and minimise unnecessay teatment and cae. Standad 2.6. Cae is povided though a model of sevice designed to delive high quality, safe and eliable healthcae Delivey of cae using high quality, safe and eliable models of sevice delivey that have the equied clinical sevices, meet legislative equiements and take into account best available evidence, national policies, National Clinical Guidelines if available, local population health needs and available esouces. Standad 7.2. Sevice povides have aangements in place to achieve best possible quality and safety outcomes fo sevice uses fo the money and esouces used. Building a Cultue of Patient Safety (DoHC, 2008) (See appendix C fo full text of ecommendation) 5.5: Oganisational pefomance indicatos and tagets in the aea of safety and quality. 5.16: Mandatoy standads and key pefomance indicatos. 5.19: Stong emphasis on safety and quality in the taining and education of healthcae pofessionals. 6.6: Licencing should be linked to compliance with stated standads. 6.9: HIQA should pogess ugently the development of standads on safety and quality. 6.11: The egulations that detemine the citeia fo obtaining a licence should include implementation of evidence-based pactice. 7.1: Poduction of evidence-based infomation and guidance fo use in policy making, system efom and individual patient and pofessional inteactions. 7.2: Evidence based sevice famewoks coveing the majo health conditions. 7.4: Evidence based national standads should be developed, with multidisciplinay input, in both pimay and seconday cae settings, and fo the tansition between cae settings. Quality Famewok fo Mental Health Sevices (MHC, 2007) Standad 8.1 The mental health sevice is deliveed in accodance with evidence-based codes of pactice, policies and potocols The mental health sevice has unifom policies acoss sevice aeas. Standad 8.3 Copoate govenance undepins the management and delivey of the mental health sevice The mental health sevice facilitates sevice use involvement at all stages of policy and sevice development, delivey and evaluation The mental health sevice implements a clinical govenance system fo impoving clinical pactice.

12 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 11 6 Standads fo Clinical Pactice Guidance ationale Diffeent types of clinical guidance will vay in complexity and scope, with the choice of clinical pactice guidance model detemined by evidence-based citeia and clinical equiements. Not all guidance equies the same pathway of development as an NCEC National Clinical Guideline. Futhe infomation is available at Howeve, egadless of the vaiation in scope and focus, it is impotant that the development of all clinical guidance is undepinned by an evidence-based appoach and quality assuance measues to assist clinician and patient decisions about appopiate healthcae fo specific clinical cicumstances. In tems of clinical pactice guidance, the health system as a whole is engaged with the development of pocesses to suppot clinical decision making at local, egional and national level as pat of the quality impovement pocess. These pocesses involve the development of policies, potocols, potocols and guidelines. The methodology to develop these pocesses is vaiable and the povision of NCEC Standads fo Clinical Pactice Guidance will pomote consistency of appoach and utilisation of appopiate methodology to develop evidencebased clinical pactice guidance nationally. The NCEC sought to establish the extent and quality of the evidence intenationally on clinical pactice guidance in tems of effectiveness, igou of development and quality assuance pocesses. A systematic liteatue eview to suppot a famewok fo the development of standads fo clinical pactice guidance was completed in Mach In summay, the published evidence on effectiveness of clinical pactice guidance is limited. The evidence eview howeve povides a useful backdop fo the development by NCEC of Standads fo Clinical Pactice Guidance. The key messages fom the liteatue included: Thee is a lack of standadisation of teminology, methodology and quality assuance of clinical pactice guidance development, implementation and evaluation intenationally. Thee is a lack of evidence elating to cost effectiveness and clinical effectiveness of clinical pactice guidance intenationally. Clinical pactice guidance must be evidence-based. Multi-stakeholde involvement is a key equiement fo the effective development of guidance. The liteatue evealed baies and facilitatos at the patient, healthcae pofessional, team, oganisational and health system level. Impovements to clinical guidance can be secued if baies ae tacked and a systems appoach is taken to the development, implementation and evaluation of guidance. The eseach team made ecommendations petaining to the development, management, implementation and evaluation of clinical guidance, including IT systems. A summay of the liteatue seach stategy and esults ae outlined in Appendix A. 2 Completed by a eseach team based in UCC. Liteatue eview is available at:

13 12 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee 7 Development of Clinical Pactice Guidance These standads aim to pomote consistency of clinical pactice guidance acoss the county and avoid duplication. Synegies should be maximised acoss depatments/oganisations to optimise value fo money and use of staff time and expetise. It is not in the inteests of patient safety fo individual oganisations/units to develop o implement diffeent guidance fo simila clinical cicumstances. Whee feasible and appopiate oganisations should pomote and utilise national clinical pactice guidance developed in line with these standads, to avoid any unnecessay duplication, encompassing any local implementation equiements as equied. Pio to commencing the development of clinical pactice guidance, the following should be established: Existing CPGs Is evidence-based clinical pactice guidance aleady available fo this topic/ clinical question? (local, national o intenational). Is the existing CPG up-to-date, pee eviewed with igoous methodology, genealisable to taget population and applicable to Ieland? Adapt/adopt Coveage/ geogaphy Is this CPG being developed de novo o being adapted/adopted fom existing guidance nationally/intenationally? Is this CPG being developed as national, egional (e.g. hospital goup/community health office) o local guidance? Will the poposed CPG be elevant fo use in a wide geogaphical aea o wide clinical aea? If so, wide collaboation needs to be consideed. In geneal, clinical pactice guidance should not vay by location, although the mechanism fo local implementation may diffe. Multidisciplinay Govenance Model Evidence base Does the CPG goup membeship include all elevant stakeholdes and pofessional goupings, to ensue integated cae fo the sevice use? Has a govenance model been established fo the development, appoval, dissemination, implementation, monitoing, audit, updating and epositoy of Clinical Pactice Guidance in you oganisation? What type of guidance is equied fo this topic/clinical question? (E.g. policy, pocedue, potocol, guideline), based on the clinical equiements. Have you established access to a libay o clinical libaian? Have you established links with an academic patne/thid level institution? The desciption of coe components in this document povides a useful checklist fo monitoing and audit.

14 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 13 Coe components A numbe of coe components fom the basis fo high quality evidence-based clinical pactice guidance, which can be gouped into the fou categoies of govenance, methodology, planning and implementation and communications. Each of these components is descibed below, with a checklist of citeia to assist in the development of clinical pactice guidance. All clinical pactice guidance should meet these standads, while some will be developed to a highe standad as equied (denoted complex CPGs below). Coe components Standads fo evidence-based Clinical Pactice Guidance Govenance Govenance model Audit, monitoing, eview & evaluation pocess Sevice use and stakeholde involvement Knowledge management Methodology Planning & Implementation Communications Claity of scope and pupose Evidence-based Resouce implications Planning & Implementation Communications These standads will be eviewed and updated by the NCEC as equied. The cuent vesion is available on Level of complexity Clinical pactice guidance may equie diffeent levels of complexity, popotionate to the type of guidance. Fo example, a National Clinical Guideline will equie a full budget impact analysis and possibly a Health Technology Assessment (HTA), wheeas a potocol may only equie consideation of the esouces equied to develop and implement the potocol. It is expected that all clinical pactice guidance will meet all minimum standads, wheeas moe complex guidance may equie additional igou. The standads below diffeentiate between minimum standads and moe igoous equiements fo complex guidance.

15 14 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee Govenance model Communications Sevice use/ stakeholde involvement Planning & Implementation Standads fo Clinical Pactice Guidance Audit, monitoing, eview and evaluation Resouce implications Knowledge management Evidence based Claity of scope and pupose Figue 2: Coe Components Standads fo Clinical Pactice Guidance

16 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 15 Standads fo Clinical Pactice Guidance 1. Claity of scope and pupose The decision making appoach elating to type of guidance equied (policy, pocedue, potocol, guideline), coveage of the guidance (national, egional, local) and applicable settings ae descibed. The oveall objective(s) of the clinical guidance ae specifically descibed. The clinical question(s) coveed by the guidance ae specifically descibed. The taget uses and the population/patient goup to whom the guidance is meant to apply ae specifically descibed. The potential fo impoved health is descibed (e.g. clinical effectiveness, patient safety, quality impovement, health outcomes, quality of life, quality of cae). The scope of the CPG is clealy descibed, specifying what is included and what lies outside the scope of the CPG. 2. Govenance model Fomal govenance aangements fo clinical pactice guidance at local, egional and national level ae established and documented. Conflict of inteest statements fom all membes of the guidance development goup ae documented, with a desciption of mitigating actions if elevant. The guidance has been eviewed by independent expets pio to publication. (as equied, complex CPGs). 3. Communications A communication plan is developed to ensue effective communication and collaboation with all stakeholdes thoughout all stages. Plan and pocedue fo dissemination of the CPG is descibed. 4. Sevice use and stakeholde involvement Stakeholde identification and involvement: The guidance development goup includes individuals fom all elevant stakeholdes, staff and pofessional goups. Guidance is infomed by the identified needs and pioities of sevice uses and stakeholdes. The views and pefeences of the taget population have been sought and taken into consideation (as equied). Thee is sevice use/lay epesentation on guidance development team (as equied).

17 16 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee 5. Evidence-based Systematic methods used to seach fo evidence ae documented (fo CPGs which ae adapted/adopted fom intenational guidance, thei methodology is appaised and documented). Citical appaisal/analysis of evidence using validated tools is documented (the stengths, limitations and methodological quality of the body of evidence ae clealy descibed). The health benefits, side effects and isks have been consideed and documented in fomulating the guidance. Thee is an explicit link between the clinical guidance and the suppoting evidence. The guidance/ecommendations ae specific and unambiguous. A systematic liteatue eview and Health Technology Assessment (HTA) has been undetaken (as equied, complex CPGs). 6. Knowledge management (Accessibility/shaing of best pactice) The clinical guidance is easily accessible by all uses e.g. CPG epositoy. Documented pocess fo vesion contol is povided. Copyight and pemissions ae sought and documented. 7. Resouce implications The potential esouce implications of developing and implementing the guidance ae identified e.g. equipment, education & taining, staff time and eseach. Synegies ae maximised acoss depatments/oganisations to avoid duplication and to optimise value fo money and use of staff time and expetise. Budget impact analysis is documented (as equied, complex CPGs). Liteatue eview of cost effectiveness is documented (as equied, complex CPGs). 8. Planning and Implementation Witten implementation plan is povided with timelines, identification of esponsible pesons/ units and integation into sevice planning pocess. Baies and facilitatos fo implementation ae identified, and aligned with implementation leves. Infomation and suppot is available fo staff on the development of evidence-based clinical pactice guidance. Thee is collaboation acoss all stakeholdes in the planning and implementation phases to optimise patient flow and integated patient cae. Education and taining is povided fo staff on the development and implementation of evidence-based clinical pactice guidance (as equied, complex CPGs). 9. Audit, monitoing, eview & evaluation pocess Pocess fo monitoing and continuous impovement is documented. Pocess fo evaluation of implementation and clinical effectiveness is specified. Audit citeia and audit pocess/plan ae specified. Documented pocess fo evisions/updating and eview, including timefame is povided.

18 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 17 Refeences Depatment of Health (2014) HSE Midland Regional Hospital, Potlaoise Peinatal Deaths (2006- date). Repot to the Ministe fo Health, D James Reilly TD fom D Tony Holohan, the Chief Medical Office. Dublin, DoH. Depatment of Health and Childen (2008) Building a Cultue of Patient Safety. Repot of the Commission on Patient Safety and Quality Assuance. Dublin, Stationay Office. Health Infomation and Quality Authoity (2011) National Quality Assuance Citeia fo Clinical Guidelines. Dublin, HIQA. Health Infomation and Quality Authoity (2012) National Standads fo Safe Bette Healthcae. Dublin, HIQA. Health Infomation and Quality Authoity (2013) Guiding Pinciples fo National Health and Social Cae Data Collections. Dublin, HIQA. Hegaty, J., Savage E., Conally, N., Byne S., Henn P, Flynn M, McLoughlin K, Fitzgeald S, (2015). A systematic liteatue eview to suppot a famewok fo the development of standads fo clinical pactice guidance. Depatment of Health; Dublin. Available at: patient-safety/ncec/clinical-pactice-guidance/ Mental Health Commission (2007) Quality Famewok. Mental Health Sevices in Ieland. Dublin, MHC. National Clinical Effectiveness Committee (2013) Guideline Developes Manual. Dublin, DoH. National Clinical Effectiveness Committee (2015) Peliminay Pioitisation Pocess National Clinical Guidelines. Dublin, DoH.

19 18 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee Souces fo coe components: Austalian Commission on Safety and Quality in Health Cae (2015) Guide to the National Safety and Quality Health Sevice standads fo health sevice oganisational boads. Sydney, NSQHS. Health Infomation and Quality Authoity (2012) National Standads fo Safe Bette Healthcae. Dublin, HIQA. National Clinical Effectiveness Committee & Health Infomation and Quality Authoity (2015) National Quality Assuance Citeia fo Clinical Guidelines. Vesion 2. To povide quality assuaance of National Clinical Guidelines in Ieland. Dublin, NCEC/HIQA. The AGREE Next Steps Consotium (2009) Appaisal of Guidelines fo Reseach & Evaluation II. AGREE II instument. The Agee Reseach Tust Souces of definitions/nomenclatue: Agency fo Healthcae Reseach and Quality (2010) Challenges and Baies to Clinical Decision Suppot (CDS) Design and Implementation Health Infomation and Quality Authoity (2014) Repot of the eview of the govenance aangements as eflected in the safety, quality and standads of sevices at UL Hospitals. Dublin, HIQA. Health Infomation and Quality Authoity (2008) National Hygiene Sevices Quality Review 2008: Standads and Citeia. Dublin, HIQA. Health Sevice Executive (2012) HSE pocedue fo developing Policies, Pocedues, Potocols and Guidelines. HSE esoucesintelligence/quality_and_patient_safety_documents/pppg_document_ Development_and_Inventoy/ Hegaty, J., Savage E., Conally, N., Byne S., Henn P, Flynn M, McLoughlin K, Fitzgeald S, (2015). A systematic liteatue eview to suppot a famewok fo the development of standads fo clinical pactice guidance. Depatment of Health; Dublin. Available at: patient-safety/ncec/clinical-pactice-guidance/ Langley G, Moen R, Nolan K, Nolan T, Noman C, Povost L (1987) The impovement guide. A pactical appoach to enhancing oganizational pefomance. 2 nd edition. San Fancisco, Jossey-Bass. National Clinical Effectiveness Committee & Health Infomation and Quality Authoity (2015) National Quality Assuance Citeia fo Clinical Guidelines. Vesion 2. To povide quality assuaance of National Clinical Guidelines in Ieland. Dublin, NCEC/HIQA. WA Health Netwoks (2007) Model of Cae: oveview and guidelines. Ensuing people get the ight cae, at the ight time, by the ight team and in the ight place. Westen Austalia, Depatment of Health. Model_of_Cae-oveview_and_guidelines.pdf

20 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 19 Appendix A: Systematic liteatue eview Key databases and gey liteatue souces wee seached fo evidence which evaluated guidance (guidance, pathway, policy, potocol, bundle, standad, algoithm, checklist, decision aid, model of cae), development, implementation and evaluation pocesses. A total of 49 papes wee included in this systematic eview (Table 1). Owing to the lack of level one evidence (i.e. RCTs, meta-analysis, systematic eviews of RCTs) and heteogeneity of methodologies and outcomes, definitive conclusions could not be made as to the effectiveness of the vaious guidance types eviewed. Howeve, the analysis of papes within the systematic eview sumised that the implementation of guidance had a positive effect on patient outcomes and on the pocesses of cae. Table 1: Systematic eview - Categoy of papes fo each type of guidance Algoithms Bundles Checklists Pathways Policy Potocols Standads of Cae TOTAL 1 SR of SRs, MAs & pimay studies Meta analysis (MAs) SRs & MA SRs of SRs SR of pimay studies SR & expet opinion Papes on developing guidance inc. SRs Total * SR = systematic eview; MA = meta-analysis *Note: 15 papes eviewed on pathways but thee papes elated to the same body of evidence (Rotte et al., 2009; 2010; 2012) Souce: Hegaty, J., Savage E., Conally, N., Byne S., Henn P, Flynn M, McLoughlin K, Fitzgeald S, (2015). A systematic liteatue eview to suppot a famewok fo the development of standads fo clinical pactice guidance. Depatment of Health; Dublin. Available at: At a national level, evidence-based guidance can be povided though: statements which assist clinical decision making (clinical guidelines); statements of intent (policy), and the aticulation of national standads against which pactice can be benchmaked. The implementation of guidance in clinical pactice can be suppoted though the use of implementation tools: potocols, algoithms and checklists. In tems of national appoaches to the oganisation and povision of evidence-based cae, these can include clinical cae pathways and cae bundles. Specific eview questions wee included in the eseach objectives fo the systematic eview including; definitions of clinical pactice guidance, coe elements, decision citeia, quality citeia, impact, esouces, updating pocesses, expetise equied, fomat, stengths and weaknesses, baies and facilitatos. Table 2 summaises the papes eviewed fo each of these aeas.

21 20 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee Table 2: Numbe of papes poviding data on each question addessed in the systematic liteatue eview Algoithms (n=9) Bundles (n=4) Checklists (n=4) Pathways (n=15)* Policy (n=9) Potocols (n=7) Standads of cae (n=2) TOTAL Q 1 Definitions Q 2 Coe elements Q 3 Decision citeia Q 4 Methodological pocesses** *** 1 29 Q 5 Quality citeia**** (fo 4 above) &/o assessment of quality of studies in eview pape Q 6 (i) Impact i.e. outcomes (ii) Method of impact validation (iii) Implementation audit incl. outcome of implementation Q 7 Resouce implications (time/ cost) Q 8 Updating pocesses Q 9 Expetise needed Q 10 Layout/fomat Q 11 (i) Stengths (ii) Weaknesses Q 12 Baies Q 13 Facilitatos *Pathways: Thee of these papes elate to one body of evidence (Rotte 2009, 2010, 2011), pesented as one pape in table. **Methodological pocesses: Most papes addessed development pocesses, some of which also epoted on implementation & evaluation. ***Potocols: One pape on potocols epoted only on implementation pocess. ****Quality citeia: This includes use of a gading system to assess the quality of evidence elevant to the development of guidance type. Souce: Hegaty, J., Savage E., Conally, N., Byne S., Henn P, Flynn M, McLoughlin K, Fitzgeald S, (2015). A systematic liteatue eview to suppot a famewok fo the development of standads fo clinical pactice guidance. Depatment of Health; Dublin. Available at:

22 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 21 Appendix B: Examples of Intenational esouces Health Impovement Scotland: Methodology toolkit management/knowledge_management_esouces/methodology_toolkit.aspx Health Impovement Scotland: Evidence fo healthcae impovement: evidence, advice, guidance and standads Austalian Commission on Safety and Quality in Health Cae: Clinical cae standads National Institute fo Health and Cae Excellence (NICE), UK; NICE pathways: NICE guidance NICE standads and indicatos NICE guidelines: the manual (2014) Intoduction%20and%20oveview NICE Evidence Sevices AGREE - intenational tool to assess the quality and epoting of pactice guidelines

23 22 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee Appendix C: Building a Cultue of Patient Safety The epot of the Commission on Patient Safety and Quality Assuance, Building a Cultue of Patient Safety (DoHC 2008) ecommends the development of evidence-based standads: Leadeship and accountability R5.1 Key leadeship oles must be assigned to designated pofessionals and agencies at national level fo the pupose of poviding stong clinical leadeship to the system in the aea of patient safety and quality. Such leadeship oles must include advocacy fo safety and quality, the development and dissemination of patient safety knowledge and leaning and the pomotion of good pactice. R5.5 Oganisational codes of govenance must be implemented which clealy identify safety and quality as a coe objective and which specify the pocesses by which these objectives will be achieved. Oganisational pefomance in these aeas should be monitoed, though, fo example, the setting of specific oganisational pefomance indicatos and tagets in the aea of safety and quality and the equiement fo egula epots via intenal and extenal accountability mechanisms on delivey against those tagets. Patients should be povided with an accessible oppotunity to contibute to such accountability mechanisms. R5.16 The Boad must eview, on a egula basis, the systems of govenance, including isk management and audit, elating to healthcae safety, quality and pefomance. This should include: mandatoy standads and key pefomance indicatos. R5.19 Thee should be a stong emphasis on safety and quality in the taining and education of healthcae pofessionals. All bodies esponsible fo the taining and continuing development of healthcae pofessionals should eview thei cuicula to ensue that patient safety and quality, including technical and human factos, is incopoated into the modules. Oganisational and Pofessional Regulatoy Famewok R6.6 Licencing should be linked to compliance with stated standads, enfoceable though inspection and imposition of sanctions if necessay. The sanctions should ange fom wanings, with time limits fo compliance, up to withdawal of licence eithe fo a specific sevice within the hospital o the hospital itself if equied. R6.9 In advance of the intoduction of legislation poviding fo licensing, HIQA should pogess ugently the development of standads on safety and quality to be applied to hospitals and all futue licensed healthcae facilities. HIQA should also be asked to commence wok immediately on standads in espect of any aea whee a high and intemediate isk to the health and/o welfae of patients o the public is identified. Subject to cuent legal povisions, aangements should be put in place by which pivate healthcae povides would voluntaily adhee to such standads, agee to be monitoed and the esulting epots published. Pivate health insues should equie all pivate healthcae facilities to adhee to the standads set by HIQA whee such standads exist. R6.11 The egulations that detemine the citeia fo obtaining a licence should include; implementation of evidence-based pactice. Quality Impovement and Leaning Systems R7.1 A leadeship ole in elation to the analysis of intenational evidence and eseach, and to the poduction of evidence-based infomation and guidance fo use in policy making, system efom and individual patient and pofessional inteactions should be developed. R7.2 A olling pogamme should be developed by the Depatment of Health, HIQA and the HSE to delive evidence-based sevice famewoks coveing the majo health conditions within the public healthcae system, simila to the National Sevice Famewoks model in the UK. Such famewoks should be eviewed peiodically to encompass new evidence on effectiveness and pefomance. R7.4 Evidence-based national standads should be developed, with multidisciplinay input, in both pimay and seconday cae settings, and fo the tansition between cae settings.

24 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 23 Appendix D: Definitions/nomenclatue examples cuently in use NCEC/ HIQA 2015 UCC systematic eview 2015 (pp 58-61) Clinical Policy Clinical policy: A witten opeational statement of intent which helps staff to make appopiate decisions and take actions, consistent with the aims of the sevice povide and in the best inteests of sevice uses. Policy: National Health Systems level policy can be consideed conceptually as an oveaching, highe level set of statements which can elate to govenance, financial and delivey aangements within which clinical (and public health) pogammes and sevices ae povided (Lavis et al., 2010). HSE PPPG 2012 Policy: A policy is a witten statement that clealy indicates the position and values of the oganisation on a given subject (HIQA, 2008). Clinical Pocedue Pocedue: A pocedue is a witten set of instuctions that descibe the appoved and ecommended steps fo a paticula act o sequence of events (HIQA, 2008). Clinical Potocol Clinical potocol: An ageed statement about a specific clinical issue, with a pecise sequence of activities to be adheed to, with little scope fo vaiation. Clinical potocols ae usually based on guidelines and/o oganisational consensus. Potocol: Specific and pecise step by step appoach often used to suppot the implementation of clinical guidelines which ae aimed at educing vaiations in clinical pactice and outcomes (Ilott et al., 2010; Ebben et al., 2013). Potocol: A potocol is defined as a witten plan that specifies pocedues to be followed in defined situations; a potocol epesents a standad of cae that descibes an intevention o set of inteventions. Potocols ae moe explicit and specific in thei detail than guidelines, they specify who does what, when and how (An Bod Altanais 2000). Potocols ae most typically used when developing instuctions fo dug pesciption, dispensing and administation, i.e. dug potocols.

25 24 Standads fo Clinical Pactice Guidance National Clinical Effectiveness Committee NCEC/ HIQA 2015 UCC systematic eview 2015 (pp 58-61) Clinical Guideline Clinical guideline: Systematically developed statements, based on a thoough evaluation of the evidence, to assist pactitione and patient decisions about appopiate healthcae fo specific clinical cicumstances, acoss the entie clinical spectum. National Clinical Guideline NCEC National Clinical Guidelines: A suite of guidelines that meet specific quality assuance and pioitisation citeia and that have been ecommended by the National Clinical Effectiveness Committee. Checklist Checklist: Tools that condense a lage volume of infomation and allow fo systematic veification of steps o pactices (Hewson et al., 2006; Hales et al., 2008; WHO 2008). HSE PPPG 2012 Guideline: A guideline is defined as a pinciple o citeion that guides o diects action (Concise Oxfod Dictionay 1995). Guideline development emphasizes using clea evidence fom the existing liteatue, athe than expet opinion alone, as the basis fo adviso mateials (WHO 2009).

26 National Clinical Effectiveness Committee Standads fo Clinical Pactice Guidance 25 NCEC/ HIQA 2015 UCC systematic eview 2015 (pp 58-61) Pathway Integated cae pathway (clinical cae pathway): a multidisciplinay cae plan that outlines the main clinical inteventions that ae caied out by diffeent healthcae pactitiones fo patients with a specific condition o set of symptoms. They ae usually locally ageed, evidenced-based plans that can incopoate local and national guidelines into eveyday pactice. Cae bundle A cae bundle is a stuctued way of impoving the pocesses of cae and patient outcomes: a small, staightfowad set of evidence-based pactices geneally thee to five that, when pefomed collectively and eliably, have been poven to impove patient outcomes. (HIQA, 2014 ) Pathway: EPA definition: A complex intevention fo the mutual decision making and oganisation of cae pocesses fo a well-defined goup of patients duing a well-defined peiod (Babiei et al., 2009). A clinical pathway: Includes a stuctued multidisciplinay plan of cae (mandatoy) Is used to tanslate guidelines o evidence into local stuctues Details the steps in a couse of teatment o cae in a plan, pathway, algoithm, guideline, potocol o othe 'inventoy of actions' Has timefames o citeia-based pogession Is aimed to standadise cae fo a specific clinical poblem, pocedue o episode of healthcae in a specific population. An intevention is called a clinical pathway if it meets the fist citeia plus thee out of the othe fou citeia (Kinsman et al., 2012). Bundle: A selected set of inteventions o pocesses of cae distilled fom evidence based pactice components that, when implemented as a goup, pesents a moe obust pictue of the quality cae povided, benchmaks pefomance and impoves patient outcomes. (Bewick, 2006) HSE PPPG 2012