Quality Standards Advisory Committee 1. Atrial fibrillation post-consultation meeting

Transcription

1 Quality Standards Advisory Committee 1 Atrial fibrillation post-consultation meeting Attendees Minutes of the meeting held on Wednesday 8 th April 2015 at the NICE offices in Manchester Standing Quality Standards Advisory Committee (QSAC) members Bee Wee (BW) [Chair], Alyson Whitmarsh (AW), Amanda de la Motte (AM), Arnold Zermansky (AZ), Gavin Maxwell (GM), Gita Bhutani (GB), Hazel Trender (HT), Hugo van Woerden (HvW), Ian Manifold (IM), Jane Worsley (JW), Juliette Millard (JM), Karen Whitehead (KW), Phillip Dick (PD), Teresa Middleton (TM) Specialist committee members Beverley Hunt (BH), Campbell Cowan (CC), Eileen Porter (EP), Gregory Lip (GL), John Campbell (JC), Matthew Fay (MF) NICE staff Jenny Mills (JM), Rachel Neary-Jones (RNJ), Shaun Rowark (SR), Stephanie Birtles (SB) Topic expert advisers None Apologies NICE observers Karen Slade, Mark Minchin Standing Quality Standards Advisory Committee (QSAC) members Helen Bromley, Jennifer Bostock, Nourieh Hoveyda, Phyllis Dunn, Sally Oliver Agenda item Discussions and decisions Actions 1. Welcome, introductions and plan for the day BW welcomed the attendees and the Quality Standards Advisory Committee (QSAC) members introduced themselves. Quality Standards Advisory Committee 1 meeting of 8

2 (private session) BW informed the Committee of the apologies and reviewed the agenda for the day. 2. Welcome and code of conduct for members of the public attending the meeting (public session) 3. Committee business (public session) BW welcomed the public observers and reminded them of the code of conduct that they were required to follow. It was stressed that they were not able to contribute to the meeting but were there to observe only. They were also reminded that the Committee is independent and advisory therefore the discussions and decisions made today may change following final validation by NICE s guidance executive. Declarations of interest BW asked standing QSAC members to declare any interests that were either in addition to their previously submitted declaration or specific to the topic(s) under consideration at the meeting today. BW asked the specialist committee members to declare all interests. The following interests were declared: 4. Topic session Atrial fibrillation (public session) 4.1 Recap of prioritisation Standing committee members TM- Attending an advisory board meeting for Pfizer in April. Specialist committee members MF- Presented at various meeting for pharmaceutical companies (including Bayer, Boehringer Ingelheim, BMS, Pfizer and Roche) for which MF s practice received payment. Advisor for the Atrial Fibrillation Association, STARS (the Syncope Trust), Arrhythmia Alliance, Anticoagulation Europe, Heart Valve Voice and occasionally for the National Stroke Association. Trustee of LifeBlood-The Thrombosis Charity. GL- Consultant for a number of pharmaceutical companies including Bayer, Astellas, Merck, AstraZeneca, Sanofi, BMS/Pfizer, Biotronik, Daiichi-Sankyo Portola and Boehringer Ingelheim BH founder of LifeBlood but no money received from pharma in relation to anticoagulation. Minutes from the last meeting The committee reviewed the minutes of the last meeting held on Tuesday 3 rd March 2015 and confirmed them as an accurate record. The committee then moved on to discuss atrial fibrillation (AF). SR and SB presented a recap of the areas for quality improvement discussed at the first QSAC meeting for atrial fibrillation: Quality Standards Advisory Committee 1 meeting of 8

3 exercise At the first QSAC meeting on Tuesday 2 nd December 2014 the QSAC agreed that the following areas for quality improvement should be progressed for further consideration by the NICE team for potential inclusion in the draft quality standard: Diagnosis and assessment Referral for specialised management Interventions to prevent stroke anticoagulation Self-monitoring 4.2 and 4.3 Presentation and discussion of stakeholder feedback and key themes/issues raised The full rationale for these decisions is available in the prioritisation meeting minutes which can be found here: Committee/QSAC1/QSAC%201%20minutes% pdf SR and SB presented the committee with a report summarising consultation comments received on atrial fibrillation. The committee was reminded that this document provided a high level summary of the consultation comments, prepared by the NICE quality standards team, and was intended to provide an initial basis for discussion. The committee was therefore reminded to also refer to the full list of consultation comments provided throughout the meeting. The committee was informed that comments which may result in changes to the quality standard had been highlighted in the summary report. Those comments which suggested changes which were outside of the process, were not included in the summary but had been included within the full list of comments, which was within the appendix. These included the following types of comment: Relating to source guidance recommendations Suggestions for non-accredited source guidance Request to broaden statements out of scope Inclusion of overarching thresholds or targets Requests to include large volumes of supporting information, provision of detailed implementation advice General comments on role and purpose of quality standards Requests to change NICE templates NICE to define valvular and non-valvular AF in the introduction of the QS and to specifically highlight in each statement which of the two the statement relates to, where required. The Committee highlighted the need to define valvular and non-valvular AF in the introduction of the QS Quality Standards Advisory Committee 1 meeting of 8

4 4.4 Discussion and agreement of final statements and to specifically highlight in each statement which of the two the statement relates to, e.g. statements 2 and 3 do not apply to valvular AF. The committee discussed each statement in turn and agreed upon a revised set. These statements are not final and may change as a result of the editorial and validation processes. Draft Quality Statement 1: Adults with risk factors for atrial fibrillation have a manual pulse palpation. The Committee discussed stakeholder feedback that asymptomatic AF (particularly in those over 65) has not been addressed in the statement. NICE reminded the Committee that there is no accredited guidance to include over 65 as a risk factor and therefore it cannot be included in the statement. The Committee felt strongly that age should be included within the statement as it is the single biggest risk factor for developing AF. The Committee discussed specifically what was meant by risk factors for developing AF and agreed that this was covered by cardiovascular risk factors, which are predominantly in older patients. The Committee agreed with stakeholder feedback that risk factors is an incorrect term and instead it should be reworded as risk factors for developing atrial fibrillation. The Committee discussed stakeholder s suggestion to include what happens following the pulse palpation and noted that it was agreed at the first meeting that pulse palpation was the key area for quality improvement and therefore this would be the statement focus, rather than follow up afterwards. The Committee also discussed a stakeholder s query of who performs this and agreed that the statement should focus on primary care. Overall it was agreed to include cardiovascular risk factors with the definitions, include for developing AF in the statement and highlight that the statement focuses on primary care only. Draft Quality Statement 2: Adults with atrial fibrillation and a CHA 2 DS 2 VAS C stroke risk score of 2 or above are offered anticoagulation. The Committee discussed stakeholder s suggestion that a CHA 2 DS 2 VAS C of 1 (excluding sex) or more should be considered but agreed that the statement should not include this. The recommendation in the guideline on a score of 1 was a consider rec and that it was therefore better, to focus this statement on one population where the anticoagulation is actually offered. The Committee discussed stakeholder s suggestion to add taking bleeding risk into account. Although included in the recommendation in the guideline, the Committee noted that patient choice should be considered and that clinical judgement should be used when offering anticoagulation. They therefore agreed not to include in the statement but to NICE to include cardiovascular risk factors with the definitions, include for developing AF in the statement and highlight that the statement applies to both primary and secondary care. NICE to keep the statement the same, include taking bleeding risk into account in the rationale, remove reference to the GRASP- AF tool and highlight that the statement only applies to non-valvular patients. Quality Standards Advisory Committee 1 meeting of 8

5 include in the rationale in more detail. They also felt that adding take bleeding risk into account could lead to the unintended consequence of too many patients not being prescribed anticoagulation correctly. The Committee also discussed stakeholder s query of whether the GRASP-AF tool should be referenced. The Committee agreed that it may not be suitable for data collection as it is not collected nationally and therefore agreed to remove. The Committee highlighted that this statement only applies to non-valvular AF patients and agreed that this should be made clear in the statement. Overall it was agreed to keep the statement the same, include taking bleeding risk into account in the rationale, remove reference to the GRASP-AF tool in data sources and highlight that the statement only applies to non-valvular patients. Draft Quality Statement 3: Adults with atrial fibrillation prescribed anticoagulation are given a choice of anticoagulants. The Committee discussed stakeholder feedback that the statement will be hard to measure if choice is included. The Committee agreed that it is the quality of choice that needs to be addressed and highlighted that the statement should include discussing the options and link to both verbal and written information. The committee suggested that any potential rewording can be based on recommendation The Committee agreed to include the NICE patient decision aid in the definitions but not in the statement itself. The Committee highlighted that this statement only applies to non-valvular AF patients. Finally the committee agreed that the rationale should make it clear that the choice is between warfarin and NOACs and NOAC may need to be offered straight away, without insisting on a mandatory trial of warfarin first. Overall it was agreed to reword the statement to include discussing the options of anticoagulants, link to the NICE patient decision aid, highlight that the statement only applies to non-valvular patients and include warfarin vs. NOACs within the rationale. Draft Quality Statement 4: Adults with atrial fibrillation taking a vitamin K antagonist with a time in therapeutic range below 65% have their anticoagulation reassessed. The Committee agreed with stakeholder comments that INR should be included in the statement along with TTR. The Committee agreed that the statement should be reworded to say poor anticoagulation control and then defined as using INR and TTR. In addition. it should be made clear that this reassessment should happen at every anticoagulation review. NICE to reword the statement to include discussing the options of anticoagulants, link to the NICE patient decision aid, highlight that the statement only applies to non-valvular patients and include warfarin vs. NOACs within the rationale. NICE to reword the statement as poor anticoagulation control and define that as using INR and TTR. Overall it was agreed to reword the statement as poor anticoagulation control and define that as using INR Quality Standards Advisory Committee 1 meeting of 8

6 and TTR. Draft Quality Statement 5: Adults with atrial fibrillation whose treatment fails to control their symptoms are referred for specialised management within 4 weeks. The Committee discussed stakeholder s concern that this statement is difficult to measure and their suggestion to include a timescale in the definition of failure to control symptoms. The Committee noted that symptoms that have failed to be controlled are patient specific and therefore subjective to each individual. However the Committee agreed that this should be reflected in the definition and that it should be on the basis of a collaborative decision with the patient. Furthermore the NICE team highlighted that the guideline does not include a timescale for how long symptoms should be uncontrolled before people are referred and therefore one could only be included in the definitions on the basis of Committee consensus. NICE agreed to liaise with specialist members outside of the meeting regarding this timeframe. The Committee also highlighted that the focus of the statement needs clarification in that it should focus on the process of being seen rather than being referred. The NICE team highlighted that this isn t specified in the guideline so agreed to take the issue away for further consideration. NICE to amend the definition and include a consensus timeframe for failure to control symptoms and focus the statement on being seen in 4 weeks rather than being referred. Overall it was agreed to amend the definition and include a consensus timeframe for failure to control symptoms and focus the statement on being seen in 4 weeks rather than being referred. Draft Quality Statement 6: (Developmental statement) Adults with atrial fibrillation taking a vitamin k antagonist are offered a coagulometer to self-monitor their coagulation status. The Committee discussed stakeholder s concerns around funding of the coagulometers. The Committee highlighted that currently these are not funded by the NHS and patients themselves need to buy them so acknowledged that there is a cost impact attached to this statement. The Committee however was reassured that the NICE diagnostics guidance on which the statement is based had found the coagulometers to be cost effective. The Committee also noted that self-monitoring is not appropriate for all patients and patients need to be on long-term vitamin K antagonists, have the ability to use the machine and training would need to be given. The Committee reflected back to the reason behind the statement and noted that self-monitoring is key to many AF patients and can considerably improve their lives. They agreed that allowing people the opportunity to self-monitor remained a priority area for quality improvement. The Committee therefore agreed that the statement as it stands is too strong and agreed that it would be more beneficial to make the statement service based focusing on the service having the ability to support self-management after initial stabilisation. NICE to reword the statement to make it service based focusing on the service having the ability to support selfmanagement. Quality Standards Advisory Committee 1 meeting of 8

7 Overall it was agreed to reword the statement to make it service based including the home monitoring possibilities as part of the package focusing on the service having the ability to support self-management. Additional areas suggested by stakeholders Not prescribing aspirin as a monotherapy to prevent stroke for people with atrial fibrillation The Committee originally discussed this at the prioritisation meeting and agreed at the time not to progress as it would mean including a negative statement in the QS. Following many suggestions to include at consultation the Committee reviewed their decision and agreed to include a new statement as they felt it to be important and a patient safety issue. NICE highlighted that to reflect the guideline a do not do statement would be progressed but agreed that it would need to be made very clear that this was about prescribing aspirin solely for AF as there may be other very legitimate reasons for prescribing. Personalised packages of care and information for patients The Committee agreed not to progress a statement here as it is sufficiently covered by the Patient Experience in adults NHS services QS (QS15). Audited care of the management of atrial fibrillation The Committee agreed not to progress a statement here as there are no guideline recommendations to underpin it and it was not felt to be a priority for a placeholder statement. Ablation and cardioversion The Committee agreed not to progress a statement here as this was not progressed at the first meeting and they still felt it not to be a key area for quality improvement. Rate and rhythm control The Committee agreed not to progress a statement here as this was not progressed at the first meeting and they still felt it not to be a key area for quality improvement. Specific statement on paroxysmal atrial fibrillation The Committee noted that this was not an area highlighted at topic engagement and therefore was not discussed at the first meeting. The Committee agreed that this is not a key area for quality improvement. NICE to draft and progress a statement based on recommendation around not prescribing aspirin. 5. Supporting the quality standard (part 1 open No additional overarching outcomes or equality and diversity considerations were suggested for this QS. RNJ presented a summary of the organisations who have expressed an interest in supporting the quality standard and asked the QSAC to consider whether any key organisations were missing. NICE to contact suggested organisations to see if they would be Quality Standards Advisory Committee 1 meeting of 8

8 session) 6. Next steps and timescales (part 1 open session) 8. Any other business (part 1 Open session) The following organisations were highlighted: Heart Valve Voice British Heart Valve Society Mechanical Valve Support Group JM outlined what will happen following the meeting and any key dates for the atrial fibrillation quality standard. No other items of business were raised. BW thanked the specialist committee members for their input into the development of this quality standard, Date of next QSAC1 meeting: Tuesday 5 th May 2015 interested in supporting the QS. Quality Standards Advisory Committee 1 meeting of 8