The committee acknowledged that discussion of prognosis should be a gradual process and may not necessarily be discussed in the first consultation as it is highly difficult to predict, particularly in the early stages of the condition. The prognosis needs to be discussed in a sensitive, open and honest manner, ensuring that the unpredictability of the prognosis and any uncertainty regarding life expectancy is conveyed. The positive effects of treatments available should also be discussed. The group acknowledged the difficulty patients may have coming to terms with information around their Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 own prognosis which highlights the importance of an immediate follow-up consultation and the engagement of family/carers (where the patient consents to their presence). This consultation provides reinforcement of the key implications of the diagnosis and prognosis and, especially where a family member or carer is present, clarification of any misperceptions. To facilitate a quick rapport with the patient and to tailor information to the patient s needs (in line with the recommendations of the patient experience guideline), the consultant committee members suggested including any preferences the patient had, regarding the level and type of information they want to be given, into the referral form from primary care. Another suggestion was for patients to complete a simple questionnaire before the first appointment identifying key areas they would like to discuss during the consultation. The committee acknowledged that the communication of these challenging issues requires specific skills that not all healthcare professionals have, and supported the provision of training in advanced communication skills to all heart failure staff. Specific information on heart failure issues could be incorporated into broader communication training for chronic or life-limiting conditions.


Specific information on heart failure issues could be incorporated into broader communication training for chronic or life-limiting conditions. The importance of consistency was discussed. It was agreed that the patient should receive consistent information from all MDT members. The committee recognised that this was closely linked to the separate evidence review on Transition between heart failure care settings and the recommendations developed out of that review. The need for printed leaflets on heart failure to be available within the NHS was unanimously agreed by the committee as patients value the provision of information that they can take away with them to read and absorb in their own time. The committee also acknowledged that patients need to be directed to reliable sources of information outside the NHS for example, British Heart Foundation, Pumping Marvellous, Cardiomyopathy UK. Trade-off between net effects and costs No previously published economic evaluations were identified for this question. The committee considered that overall the recommendations made above in conjunction with the patient experience guideline would improve patient satisfaction and help reduce anxiety about their condition and as a result lead to an improvement in quality of life. The majority of the recommendations made above will not incur any cost as they simply specify what information should be given to patients and the manner in which it should be delivered. However, the committee acknowledged that a couple of the recommendations could have cost implications. Firstly, an extended first consultation will incur an additional cost due to the required extra time from the clinician to fully explain the person s diagnosis and prognosis.


Firstly, an extended first consultation will incur an additional cost due to the required extra time from the clinician to fully explain the person s diagnosis and prognosis. However, the committee considered that a standard consultation appointment is unlikely to be long enough to allow sufficient time to explain the diagnosis and prognosis as recommended in the patient experience guideline and thought this was necessary for good clinical practice. Furthermore, this type of recommendation is endorsed by the patient experience guideline which specifies that when discussing patient views and preferences that adequate time should be allowed so that Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 discussion does not seemed rushed. In many centres, extended consultations are likely to already be occurring. The committee also acknowledged that further communication training would incur a cost. The committee were aware of training for other chronic conditions that could also be extended to heart failure specialists. Furthermore, such training is likely be undertaken in a group setting to minimise cost, or alternatively could be provided through e-learning, or at medical school in future. The committee acknowledged that the benefits of improved communication training would be advantageous across the entire treatment pathway for chronic heart failure patients as well as other conditions outside of heart failure, and therefore overall, the long-term cost effectiveness of training in effective communication is likely to be negligible. Other considerations The committee acknowledged The Second Conversation Project which was currently piloting an educational intervention, to enable junior doctors to build their skills and confidence in navigating end of life discussions which they agreed would provide insight into the benefit of this type of training and may be extrapolated to the heart failure population.


Other considerations The committee acknowledged The Second Conversation Project which was currently piloting an educational intervention, to enable junior doctors to build their skills and confidence in navigating end of life discussions which they agreed would provide insight into the benefit of this type of training and may be extrapolated to the heart failure population. 9.5.1 Multi-disciplinary teams 71.The core specialist heart failure multidisciplinary team (MDT) should work in collaboration with the primary care team, and should include: a lead physician with a subspecialty interest in heart failure (usually a consultant cardiologist) who is responsible for making the clinical diagnosis a specialist heart failure nurse a healthcare professional with expertise in specialist prescribing for heart failure. 72.The specialist heart failure MDT should directly involve, or refer people to, other services, including rehabilitation services, and tertiary and palliative care, as needed. [2018] 73.The specialist heart failure MDT should: diagnose heart failure give information to people newly diagnosed with heart failure (see section 9.4.6) manage newly diagnosed, recently decompensated or advanced heart failure (NYHA [New York Heart Association] class III to IV) heart failure optimise treatment start new medicines that need specialist supervision continue to manage care after an interventional procedure such as implantation of a cardioverter defibrillator or cardiac resynchronisation device manage heart failure that is not responding to treatment. [2018] Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights.


[2018] Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 9.5.2 Transition between heart failure care settings 74.The primary care team should carry out the following for people with heart failure at all times, including periods when the person is also receiving specialist heart failure from the MDT: ensure effective communication links between different care settings and clinical services involved in the person s care lead a full review of the person s heart failure care, which may form part of a long-term conditions review recall the person at least every 6 months and update the summary and clinical record ensure that changes to the clinical record are understood and agreed by the person with heart failure and shared with the specialist heart failure MDT arrange access to specialist heart failure services if needed. [2018] 9.5.2.1 Care after an acute event For recommendations on the diagnosis and management of acute heart failure see NICE s guideline on acute heart failure. 75.People with heart failure should generally be discharged from hospital only when their clinical condition is stable and the management plan is optimised. Timing of discharge should take into account the wishes of the person and their family or carer, and the level of care and support that can be provided in the community. [2003] 76. The primary care team working within the specialist heart failure MDT should take over routine management of heart failure as soon as it has been stabilised and its management optimised.


The primary care team working within the specialist heart failure MDT should take over routine management of heart failure as soon as it has been stabilised and its management optimised. [2018] 9.5.2.2 Writing a care plan 77.The specialist heart failure MDT should write a summary for each person with heart failure that includes: diagnosis and aetiology medicines prescribed, monitoring of medicines, when medicines should be reviewed and any support the person needs to take the medicines functional abilities and any social care needs social circumstances, including carers' needs. [2018] 78.The summary should form the basis of a care plan for each person, which should include. plans for managing the person s heart failure, including follow-up care, rehabilitation and access to social care symptoms to look out for in case of deterioration a process for any subsequent access to the specialist heart failure MDT if needed contact details for: a named healthcare coordinator (usually a specialist heart failure nurse) local heart failure specialist care providers, for urgent care or review additional sources of information for people with heart failure. [2018] Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 79.Give a copy of the care plan to the person with heart failure, ther family or carer if appropriate, and all health and social care professionals involved in their care. [2018] 9.5.3 Information and support needs regarding diagnosis and prognosis 80.When giving information to people with heart failure, follow the recommendations in the NICE guideline on patient experience in adult NHS services. [2018] 81.Discuss the person's prognosis in a sensitive, open and honest manner. Be frank about the uncertainty in predicting the course of their heart failure. Revisit this discussion as the person's condition evolves.


Be frank about the uncertainty in predicting the course of their heart failure. Revisit this discussion as the person's condition evolves. [2018] 82.Provide information whenever needed throughout the person s care. [2018] 83.Consider training in advanced communication skills for all healthcare professionals working with people who have heart failure. [2018] 9.5.3.1 First consultations for people newly diagnosed with heart failure 84.The specialist heart failure MDT should offer people newly diagnosed with heart failure an extended first consultation, followed by a second consultation, to take place within 2 weeks if possible. At each consultation: discuss the person s diagnosis and prognosis explain heart failure terminology discuss treatments address the risk of sudden death, including any misconceptions about that risk encourage the person and their family or carers to ask any questions they have. [2018] Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 10 Advanced heart failure and palliative care The update to the heart failure guideline includes topics where new evidence has emerged since the publication in 2010. A review of new evidence published after 2010 was carried out in order to determine whether any changes to current recommendations where likely to be required. The decision on which topics to include in the update of the guideline was made following consultation of the scope. In this section new evidence was reviewed on the use of diuretics, domiciliary oxygen therapy and criteria for discussing ICD deactivation in patients with advanced heart failure, and the use of validated risk tools to identlfy patients with an increased risk of mortality.


In this section new evidence was reviewed on the use of diuretics, domiciliary oxygen therapy and criteria for discussing ICD deactivation in patients with advanced heart failure, and the use of validated risk tools to identlfy patients with an increased risk of mortality. 10.1 Diuretics in advanced heart failure The use of diuretics is undoubtedly helpful in cases of systemic fluid overload or pulmonary congestion, and remain the only group of medication where there is consensus about its benefit in relieving the breathlessness in patients who have heart failure with preserved left ventricular ejection fraction (HFPEF). An important question arises in patients with advanced heart failure receiving palliative care in the community, is which route of administration of diuretics is most clinically and cost effective? 10.1.2 Review question: Which route of administration of diuretics (intravenous (IV), subcutaneous or oral) is most clinically and cost effective in people with advanced heart failure who are in the community, including patients receiving palliative care? For full details see review protocol in appendix A. Table 141: PICO characteristics of review question Population Advanced heart failure in the community Interventions / comparators IV diuretics (furosemide or torsemide) (continuous or bolus) + oral metolazone/thiazides IV diuretics (furosemide or torsemide) (continuous or bolus) alone Subcutaneous diuretics (furosemide or torsemide) +/- oral metolazone/thiazides Oral diuretics (bumetanide or furosomide and/or metolazone/thiazides). All compared to each other Thiazides are limited to: Bendroflumethiazide (Bendrofluazide) Cyclopenthiazide Chlorthalidone / Chlortalidone Indapamide Xipamide Metolazone Outcomes CRITICAL Quality of life Unplanned hospitalization Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights.


All compared to each other Thiazides are limited to: Bendroflumethiazide (Bendrofluazide) Cyclopenthiazide Chlorthalidone / Chlortalidone Indapamide Xipamide Metolazone Outcomes CRITICAL Quality of life Unplanned hospitalization Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 IMPORTANT Change in dyspnoea Weight change / change in oedema Change in NYHA class Patient and carer satisfaction Time to death (survival) Successful administration of intervention Study design Systematic Review RCT 10.1.3 Clinical evidence A search was conducted for randomised trials and systematic reviews of randomised trials comparing the effectiveness of different modes of administration of diuretics in people with advanced heart failure in the community. No relevant studies were identified. See appendix I for the excluded studies table. 10.1.4 Economic evidence Published literature No relevant health economic studies were identified. See also the health economic study selection flow chart in appendix D. 10.1.5 Evidence statements Clinical No relevant published evidence was identified. Economic No relevant economic evaluations were identified. 10.1.6 Recommendations and link to evidence Recommendations No recommendation Research recommendation In people with advanced heart failure and significant peripheral fluid overload, what is the clinical and cost effectiveness of oral, subcutaneous and intravenous diuretic therapy in the community? Relative values of different outcomes The committee agreed that the outcomes critical for decision making were quality of life, unplanned hospitalisations (count rate) and unplanned hospitalisations (number of bed days), while the outcomes change in dyspnoea, weight change/change in oedema, change in NYHA class, patient and carer satisfaction, time to death or survival and successful administration of the intervention were important for decision making. Quality of the clinical evidence No clinical evidence was identified for inclusion within the review.


Quality of the clinical evidence No clinical evidence was identified for inclusion within the review. Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation In people with advanced heart failure and significant peripheral fluid overload, what is the clinical and cost effectiveness of oral, subcutaneous and intravenous diuretic therapy in the community? Trade-off between clinical benefits and harms As no randomised controlled studies were found that addressed the review question, the committee was not able to make a recommendation on the clinical effectiveness of IV and oral diuretics delivered in the community. The committee decided to make a research recommendation to establish the added value of IV or subcutaneous diuretics (in terms of its clinical and cost effectiveness) in the management of advanced heart failure, for the reasons discussed below. Trade-off between net clinical effects and costs No previously published economic evaluations were identified. Unit costs were not presented for this review due to the lack of clinical evidence available for the committee to make a judgement of cost effectiveness of the routes of administration of diuretics. However, the committee noted that delivering diuretics subcutaneously and intravenously would incur a higher cost to the NHS compared to administering oral diuretics due to the additional equipment and staff costs of delivery The committee agreed that due to the greater cost of subcutaneous and IV diuretics therapy compared to oral diuretics, it was important that an assessment of the cost effectiveness of these different administration routes was included in the research recommendation. Other considerations The committee considered the use of IV and subcutaneous diuretics in people with advanced chronic heart failure to be an area of high priority for future research.


Other considerations The committee considered the use of IV and subcutaneous diuretics in people with advanced chronic heart failure to be an area of high priority for future research. The committee highlighted that the delivery of these treatments in the community was variable across the country and was dependant on whether or not commissioning for the service was in place. The committee noted that for many advanced heart failure patients, some of whom may be approaching the end of their life, the focus of treatment may shift to symptom relief, admission avoidance, maintaining quality of life and minimising discomfort. These patients may become less responsive to conventional oral doses of loop diuretics and resistance can occur. The committee discussed whether subcutaneous diuretics may be more effective than oral diuretics but this route requires delivery by healthcare professionals. Likewise, IV diuretics could prove to be more effective than oral and subcutaneous diuretics in managing symptoms, but they are invasive, may not be feasible or appropriate in people in the later stages of heart failure. For those reasons, the committee decided to make a research recommendation to establish the added value of IV or subcutaneous diuretics (in terms of its clinical and cost effectiveness) in people with advanced heart failure, with significant peripheral fluid overload, in the community. The committee acknowledged the BHF funded pilot study Report-IV-Diuretics-August-2014.pdf) which consisted of a 2 year project in 10 NHS organisations across the UK in both urban and rural areas to assess Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights.


The committee acknowledged the BHF funded pilot study Report-IV-Diuretics-August-2014.pdf) which consisted of a 2 year project in 10 NHS organisations across the UK in both urban and rural areas to assess Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation In people with advanced heart failure and significant peripheral fluid overload, what is the clinical and cost effectiveness of oral, subcutaneous and intravenous diuretic therapy in the community? whether funding a home or community based IV diuretics service was safe, clinically effective, cost effective and well received by patients and carers. The committee noted that this study was not randomised and therefore did not meet the methodological threshold for inclusion within this review. 10.2 Domiciliary oxygen therapy in people with advanced heart failure Breathlessness is a common symptom in advanced heart failure even with optimal pharmacological and non pharmacological treatments and the absence of clinical pulmonary oedema. Current British Thoracic Society guidelines (2015)142 .for home oxygen state that only hypoxaemic patients with PO2 below 7.3kpa or 8 (with peripheral oedema, polycythaemia or pulmonary hypertension) should receive any form of home oxygen therapy except for a specific group with sleep disordered breathing. They specifically state that palliative oxygen therapy should not be provided to non hypoxaemic or mildly hypoxaemic patients. However, the evidence base for these recommendations was limited Therefore an up-to date review of the literature in this area is warranted. 10.2.2 Review question: What is the effectiveness of domiciliary oxygen therapy in people with advanced heart failure For full details see review protocol in appendix A.


10.2.2 Review question: What is the effectiveness of domiciliary oxygen therapy in people with advanced heart failure For full details see review protocol in appendix A. Table 142: PICO characteristics of review question Review population Adults (aged 18 years and over) with advanced heart failure (whether living in a care home (community residential facility), at home or in a hospice). These patients may be approaching the end of their life and may be receiving other palliative care services. Trials of patients with heart failure and other co-morbidities such as sleep apnoea and COPD will be included (however, see exclusions). Interventions/co mparators Domiciliary oxygen therapy (repeated long term use (daily availability)) No oxygen therapy o Medical air o Handheld fan o No treatment Different doses of oxygen will be pooled in the analysis. Outcomes CRITICIAL Quality of life at 2 weeks (Continuous) Change in breathlessness at 2 weeks (Continuous) Unplanned hospitalization at 4 weeks (Count rate) Unplanned hospitalization at 4 weeks (number of bed days) Patient and carer satisfaction 2 weeks (Continuous) Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 IMPORTANT Change in exercise capacity at 2 weeks (Continuous) Change in NYHA class at 2 weeks (Continuous) Shorter term time points will also be extracted if reported in the studies but may be downgraded for indirectness in consultation with the GC. Study design Systematic Review RCT 10.2.3 Clinical evidence A search was conducted for randomised trials comparing the effectiveness of domiciliary oxygen therapy versus no oxygen therapy or usual care as treatment for the symptoms (particularly breathlessness) of advanced heart failure. One study was included in the review63 which is summarised in Table 143 below.


One study was included in the review63 which is summarised in Table 143 below. The study was a HTA report which was stopped early due to poor adherence to the prescribed oxygen therapy in the intervention arm of the trial. Evidence from this study is summarised in the clinical evidence summary below (Table 144). See also the study selection flow chart in appendix C, forest plots in appendix E, study evidence tables in appendix F, GRADE tables in appendix H and excluded studies list in appendix I. The study originally included a third arm which comprised nocturnal oxygen therapy (assumed to be 8 hours per night). This arm of the trial was dropped before trial completion due to problems with both centre and patient recruitment. The study authors reported data for this arm of the trial for several outcomes including quality of life. The study authors conducted an exploratory analysis, including all 3 treatment arms and found no significant difference between the nocturnal therapy (NOT) and long term oxygen therapy (LTOT) arms, therefore the authors combined these arms and compared them against the best medical therapy (BMT) arm for participants recruited up until 30 April 2013. To avoid double counting and maximise the number of participants analysed in either arm we have not included this comparison and included only the data reported for LTOT versus BMT at 3 months for this outcome. Table 143: Summary of studies included in the review Study Intervention and comparison Population Outcomes Comments Intervention 1: Long term oxygen therapy (LTOT) prescribed for 15 hours per day including overnight hours.


Table 143: Summary of studies included in the review Study Intervention and comparison Population Outcomes Comments Intervention 1: Long term oxygen therapy (LTOT) prescribed for 15 hours per day including overnight hours. Nocturnal oxygen therapy (NOT) (assumed to be 8 hours per night) Comparator: Best medical therapy (BMT) which consisted of Participants with severe heart failure with NYHA class III or IV left ventricular systolic dysfunction receiving optimal medical therapy who were stable but severely symptomatic Age (mean (SD)): Quality of life (MLWHF) at 3 months Quality of life months Hospitalisation at NRS for breathlessness at 6 minute walk test at 6 months Outcomes were downgraded for indirectness due to the long follow up period Chronic Heart Failure Domiciliary oxygen therapy in people with advanced heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments maximally tolerated medical management and target doses of a renin-angiotensin system inhibitor, a beta-adrenoceptor antagonist and an aldosterone antagonist Gender (M/F): Ethnicity not reported UK Domiciliary oxygen therapy in people with advanced heart failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights.


ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments maximally tolerated medical management and target doses of a renin-angiotensin system inhibitor, a beta-adrenoceptor antagonist and an aldosterone antagonist Gender (M/F): Ethnicity not reported UK Domiciliary oxygen therapy in people with advanced heart failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 144: Clinical evidence summary: long term oxygen therapy versus best medical therapy Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Best medical therapy Risk difference with Long term oxygen therapy (95% CI) Quality of life (MLWHF) VERY LOWa,b,c due to risk of bias, indirectness, imprecision The mean quality of life (MLWHF) in the control groups was The mean quality of life (MLWHF) in the intervention groups was Quality of life (EQ- VERY LOWa,b due to risk of bias, indirectness The mean quality of life (EQ-5D-3L) in the control groups was The mean quality of life (EQ-5D-3L) in the intervention groups was (0.1 lower to 0.12 higher) VERY LOWa,b,c due to risk of bias, indirectness, imprecision Rate ratio 360 events per 1000 person-years 54 fewer events per 1000 person-years (from 165 fewer to 119 more) NRS for breathlessness (Scale from: 0 to 10) VERY LOWa,b,c due to risk of bias, indirectness, imprecision d The mean NRS for breathlessness in the intervention group was (1.57 lower to 0.31 higher) 6 minute walk test 74 VERY LOWa,b due to risk of bias, indirectness d The mean 6 minute walk test in the intervention group was 0.64 metres higher (34.54 lower to 35.82 higher) (a) Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias.


ISBN: Table 144: Clinical evidence summary: long term oxygen therapy versus best medical therapy Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Best medical therapy Risk difference with Long term oxygen therapy (95% CI) Quality of life (MLWHF) VERY LOWa,b,c due to risk of bias, indirectness, imprecision The mean quality of life (MLWHF) in the control groups was The mean quality of life (MLWHF) in the intervention groups was Quality of life (EQ- VERY LOWa,b due to risk of bias, indirectness The mean quality of life (EQ-5D-3L) in the control groups was The mean quality of life (EQ-5D-3L) in the intervention groups was (0.1 lower to 0.12 higher) VERY LOWa,b,c due to risk of bias, indirectness, imprecision Rate ratio 360 events per 1000 person-years 54 fewer events per 1000 person-years (from 165 fewer to 119 more) NRS for breathlessness (Scale from: 0 to 10) VERY LOWa,b,c due to risk of bias, indirectness, imprecision d The mean NRS for breathlessness in the intervention group was (1.57 lower to 0.31 higher) 6 minute walk test 74 VERY LOWa,b due to risk of bias, indirectness d The mean 6 minute walk test in the intervention group was 0.64 metres higher (34.54 lower to 35.82 higher) (a) Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias. (b) The majority of the evidence was from studies with follow up periods longer than stated by the review protocol. (c) Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs.


(c) Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs. (d) Unable to calculate as the study reported the result as a mean difference. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 10.2.4 Economic evidence Published literature No relevant health economic studies were identified. See also the health economic study selection flow chart in appendix D. 10.2.5 Evidence statements Clinical One study including 114 people with severe heart failure was identified for inclusion within the review. The evidence compared long term oxygen therapy (prescribed for 15 hours per day) with best medical therapy (consisting of maximally tolerated medical management and target doses of a renin-angiotensin system inhibitor, a beta-adrenoceptor antagonist and an aldosterone antagonist). The evidence from this study was very low quality due to a risk of bias, imprecision due to wide confidence intervals and indirectness of the outcomes due to the long follow up period. The study was terminated early. No clinical effect was observed for the outcomes quality of life, breathlessness and the 6 minute walk test. A clinically important reduction in hospitalisations was observed. No evidence was found for the outcomes patient and carer satisfaction, change in NYHA class and unplanned hospitalisation (number of bed days). Economic No relevant economic evaluations were identified. 10.2.6 Recommendations and link to evidence Recommendations Do not offer long-term home oxygen therapy for advanced heart failure. Be aware that long-term home oxygen therapy may be offered for comorbidities, such as for some people with chronic obstructive pulmonary disease (see section 1.2.5 on oxygen in the NICE guidline on chronic obstructive pulmonary disease in over 16s.


Be aware that long-term home oxygen therapy may be offered for comorbidities, such as for some people with chronic obstructive pulmonary disease (see section 1.2.5 on oxygen in the NICE guidline on chronic obstructive pulmonary disease in over 16s. [2018] Relative values of different outcomes The committee agreed that the outcomes critical for decision making were quality of life, change in breathlessness, unplanned hospitalisation (both number of bed days and number of events) and patient and/or carer satisfaction. The important outcomes for decision making were change in exercise capacity and change in NYHA class. Quality of the clinical evidence One study was included in the review. The quality of the evidence was very low. This was due to a high risk of bias resulting from a lack of blinding and incomplete outcome data for a number of the reported outcomes. All of the outcomes were also downgraded due to the indirectness of the follow-up period. The committee originally specified short follow-up points for the outcomes of interest as they felt these would be the most appropriate for a population consisting of people with advanced heart failure who may be receiving palliative care. The included evidence reported follow-up periods of 3 months as a minimum. The committee discussed that this indicated the study population may not have been representative of people with advanced disease. The study also reported some results for a third arm nocturnal oxygen therapy (NOT) which was discontinued early due to issues with trial funding. The committee agreed that due to this early discontinuation and the Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights.


The committee agreed that due to this early discontinuation and the Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 selective nature of the outcome reporting on this arm of the trial, the data reported for this arm would not be analysed. Trade-off between clinical benefits and harms In people with severe heart failure, domiciliary oxygen prescribed for up to 15 hours per day was associated with no clinically important effect on quality of life, breathlessness or the 6 minute walk test. A clinically important benefit (also consistent with clinical harm due to wide confidence intervals) was observed with regard to the number of hospitalisations. The committee discussed the risks and harms associated with oxygen therapy, which included the potential of significant anxiety for the patient caused by the noisy and imposing equipment involved. The potential risk of combustion for people in unsatisfactory living conditions was also acknowledged, that is, people who smoke or live with others who smoke The committee also discussed the possibility of high oxygen levels to further damage heart tissue as a potential harm of oxygen therapy.The committee agreed that the provision of oxygen should be based on a holistic needs assessment and would be very specific to each individual. Oxygen therapy would not be withheld from a person where a potential benefit was identified or where significant relief of breathlessness had been observed, however, the routine prescription of oxygen was not necessary for people with advanced heart failure. Trade-off between net clinical effects and costs No previously published economic evaluations were identified for this review.


Trade-off between net clinical effects and costs No previously published economic evaluations were identified for this review. The committee agreed that domiciliary oxygen therapy is likely to be expensive as it requires regular visits to deliver new tanks of oxygen and associated equipment, as well as safe installation, risk assessment and maintenance of the oxygen. In addition, people on oxygen therapy should be regularly reviewed to assess their oxygen levels. The clinical evidence suggested there was no clinically important effect on quality of life, although this was highly uncertain. Due to the poor quality of the clinical evidence the committee could not assess the cost effectiveness of domiciliary oxygen therapy in people with advanced heart failure. However, due to the potentially high cost, and the known risks of oxygen therapy (described in the trade-off between clinical benefits and harms above) the committee decided that long term oxygen therapy should not be routinely offered to people with advanced heart failure. Current practice is thought to be widely variable, but is not commonly used as part of routine care in people with heart failure. The committee considered that this recommendation would not substantially change current practice, but could lead to some small cost savings. Other considerations The committee felt that it was important to be aware that people with advanced heart failure with other comorbid conditions may benefit from oxygen therapy. Examples where this may be the case include chronic lung disease such as COPD (https://www.nice.org.uk/guidance/cg101), or patients with pneumonia or pulmonary embolism. In addition to this, people who are in the last weeks of life may find oxygen therapy of symptomatic benefit and comfort and should be referred to the care of the dying adult guideline (https://www.nice.org.uk/guidance/ng31).


In addition to this, people who are in the last weeks of life may find oxygen therapy of symptomatic benefit and comfort and should be referred to the care of the dying adult guideline (https://www.nice.org.uk/guidance/ng31). The committee also discussed the recently published British Thoracic Society Guideline for oxygen use in adults in healthcare and emergency settings (https://www.brit-thoracic.org.uk/document-library/clinical- use-in-adults-in-healthcare-and-emergency-settings/) which states that people should only be prescribed oxygen in palliative care when arterial oxygen saturation is Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 less than 90% or where people report significant relief of breathlessness from oxygen. The committee acknowledged that this guideline was not specifically formulated for people with advanced heart failure but agreed with the approach nonetheless. The committee also acknowledged the British Thoracic Society Guidelines for Home Oxygen use in adults which state that people with advanced heart failure should be offered long term oxygen therapy if they have a resting Pa02 7.3 kPa or 8 kPa in the presence of peripheral oedema, polycythaemia (haematocrit 55%) or evidence of pulmonary hypertension on ECG or echocardiography. Where symptomatic hypoxaemia was identified with unknown cause, this would need to be investigated by the appropriate specialist in order that a root cause can be identified and treatment tailored appropriately. With regard to the evidence included within review, the committee acknowledged that the discontinuation of the trial due to poor adherence was suggestive that the trial population were not receiving any significant benefit from oxygen therapy to justify them adhering to the intervention. 10.3 Discussing Implantable Cardioverter Defibrillatior (ICD) deactivation An increasing number of people are undergoing an implantable Cardioverter Defibrillator (ICD) implantation, with or without Cardiac Resynchronisation Therapy (RCT).


10.3 Discussing Implantable Cardioverter Defibrillatior (ICD) deactivation An increasing number of people are undergoing an implantable Cardioverter Defibrillator (ICD) implantation, with or without Cardiac Resynchronisation Therapy (RCT). With the advent of ICDs the risk of sudden cardiac death has been reduced. However, maintaining these activities becomes undesirable towards the end stage of chronic heart failure when the patient s survival ceases to be the prime aim of treatment, and the target of therapy increasingly becomes the palliation of the symptoms. The point maybe reached when the potential benefits of an ICD are likely to be outweighed by their disadvantages. To deactivate the ICD is a major decision that ought to be taken after consideration of all major factors involved and in an open, informed, and inclusive manner. The timing of such a decision is a complex matter related to difficulties faced by health-care professionals in trying to determine where the patient is on the trajectory of chronic heart failure. Although a number of charities and professional bodies have written policies around the optimal timing of these discussions there is no consensus in clinical practice. Diverse views have also been expressed by people with heart failure and their families or carers about the implications of deactivation of ICDs. This diversity of views is further compounded by the different healthcare professionals involved and the different potential settings in which discussions can occur. This question looked to find evidence from the published literature as to what were the issues in this field and how these findings could be used to guide discussions about the timing of deactivation of defibrillators. 10.3.2 Review question: What criteria should determine when to discuss defibrillator deactivation? For full details see review protocol in appendix A.


10.3.2 Review question: What criteria should determine when to discuss defibrillator deactivation? For full details see review protocol in appendix A. Table 145: Characteristics of review question Objective To understand the views of patients, family, carers and healthcare staff regarding the timing of discussions about the deactivation of ICDs. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Population and setting Patients with heart failure in a primary care, outpatient or community setting. Context Any description of patient, family, carer or healthcare staff experiences or preferences relating to the timing of discussions regarding the deactivation of an ICD. Review strategy Synthesis of qualitative research. Results presented in narrative format. Quality of the evidence will be assessed by a GRADE CerQual approach for each review finding. 10.3.3 Qualitative evidence This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual236 . Methods specific to this review question are described in the review protocol in appendix A. Declarations of interest were recorded according to NICE s 2014 conflicts of interest policy. 10.3.3.2 Summary of included studies these are summarised in Table 146 below. Key findings from these studies are summarised in Section 10.3.3.3 below. See also the study selection flow chart in appendix C, study evidence tables in appendix F, and excluded studies lists in appendix I. Five of these studies explored patient experiences, 6 explored healthcare professional experiences and 2 explored family member experiences. Table 146: Summary of studies included in the review Study Design Population Research aim Setting Brannstrom Interviews and thematic content analysis cardiologists, 12 internists) To describe healthcare professionals' experiences in end of life care for heart failure patients.


Table 146: Summary of studies included in the review Study Design Population Research aim Setting Brannstrom Interviews and thematic content analysis cardiologists, 12 internists) To describe healthcare professionals' experiences in end of life care for heart failure patients. Sweden Cheang Survey and framework analysis approach Consultants, clinical nurse specialists, other palliative nurses and non-consultant doctors that were mainly based in hospices. To investigate why palliative care in heart failure may be underutilised, in order to identify problems in current practice that may impact the provision of care UK Fluur Semi-structured interviews and thematic analysis Spouses of ICD-recipients at least 6 months post implant, who were in a stable phase of their illness trajectory (mean age 61 years) To explore future reflections of spouses living with ICD recipients, with a focus on end of life care issues. Sweden Fluur Semi-structured interviews and thematic analysis 37 ICD-recipients with a median time since first implantation of 4.5 years and a mean age of 64 years, and who were not in the palliative To explore patients' experiences of complex issues of battery replacement and deactivation of the Sweden Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Design Population Research aim Setting phase of a terminal illness.


ISBN: 978-1-4731-3093-7 Study Design Population Research aim Setting phase of a terminal illness. ICD Goldstein Interviews and constant comparative methods 12 healthcare professionals (electrophysiologists, cardiologists and generalists) To understand barriers to physician initiated discussions about ICD deactivation USA Goldstein Interviews and constant comparative methods 15 ICD-recipients (median age 69 years), 10 patients had their device for over a year and 8 patients had received a shock To understand patient barriers to discussions about ICDs in patients with advanced illness USA Kramer Focus groups and grounded theory 14 nurses who were registered from the Division of Cardiovascular Diseases at the Mayo clinic To identify nurses' concerns relating to deactivating cardiac devices USA Interviews and thematic analysis 6 family members of ICD- recipients (3 children and 3 spouses) To explore family members' experiences of ICD decision making, in order to inform decision making and improve the quality of end of life care.


ICD Goldstein Interviews and constant comparative methods 12 healthcare professionals (electrophysiologists, cardiologists and generalists) To understand barriers to physician initiated discussions about ICD deactivation USA Goldstein Interviews and constant comparative methods 15 ICD-recipients (median age 69 years), 10 patients had their device for over a year and 8 patients had received a shock To understand patient barriers to discussions about ICDs in patients with advanced illness USA Kramer Focus groups and grounded theory 14 nurses who were registered from the Division of Cardiovascular Diseases at the Mayo clinic To identify nurses' concerns relating to deactivating cardiac devices USA Interviews and thematic analysis 6 family members of ICD- recipients (3 children and 3 spouses) To explore family members' experiences of ICD decision making, in order to inform decision making and improve the quality of end of life care. USA Maclver Interviews and grounded theory analysis 25 heart failure patients with ICDs (mean age 62 years) To determine patient awareness and understanding of ICD deactivation Canada Morrison Survey and coding 112 palliative care professionals (51% physicians, 48% nurses and 1% other) To explore palliative care providers experiences and attitudes of managing ICDs USA Mueller Focus groups and content analysis 17 industry employed allied professionals working in a clinical setting to monitor cardiac implantable electronic devices, who had performed at least one device deactivation To identify issues related to role conflicts and moral distress experienced with the cardiovascular implantable electronic device industry USA Strachan Interviews and grounded theory 24 ICD recipients and 6 participants who declined an ICD (age 26 to 87 years) To examine patient experiences of end of life care issues Canada Svanholm Phenomenological and interpretive approach 11 ICD-recipients (mean age 82.8 years) who were expecting a device replacement within 2 years To identify areas for improvement in discussions between healthcare professionals and patients related to ICDs.


USA Maclver Interviews and grounded theory analysis 25 heart failure patients with ICDs (mean age 62 years) To determine patient awareness and understanding of ICD deactivation Canada Morrison Survey and coding 112 palliative care professionals (51% physicians, 48% nurses and 1% other) To explore palliative care providers experiences and attitudes of managing ICDs USA Mueller Focus groups and content analysis 17 industry employed allied professionals working in a clinical setting to monitor cardiac implantable electronic devices, who had performed at least one device deactivation To identify issues related to role conflicts and moral distress experienced with the cardiovascular implantable electronic device industry USA Strachan Interviews and grounded theory 24 ICD recipients and 6 participants who declined an ICD (age 26 to 87 years) To examine patient experiences of end of life care issues Canada Svanholm Phenomenological and interpretive approach 11 ICD-recipients (mean age 82.8 years) who were expecting a device replacement within 2 years To identify areas for improvement in discussions between healthcare professionals and patients related to ICDs. Denmark 10.3.3.3 Qualitative evidence synthesis Three findings were identified, with multiple sub-findings. These are described below. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Table 147: Finding 1: Attitudes and understanding Sub-finding Statement of sub-finding Awareness ICD recipients and family members were unaware that ICDs could be deactivated.


ISBN: 978-1-4731-3093-7 Table 147: Finding 1: Attitudes and understanding Sub-finding Statement of sub-finding Awareness ICD recipients and family members were unaware that ICDs could be deactivated. Misconception People perceived deactivation to be equivalent to euthanasia or suicide, resulting in immediate death Not wanting to deactivate People did not want to deactivate regardless of the circumstances Wanting to deactivate People wanted to deactivate when they were bedridden with an extremely low quality of life Table 148: Finding 2: Discussions Sub-finding Statement of sub-finding Initiating the conversation Some patients felt that healthcare professionals should start the conversation, whereas others felt that this would be emotionally distressing Starting the conversation early Some felt that discussions should be started early while they were able to make decisions Having the conversation later Some felt discussions should occur later on or when there was a change in their condition Avoiding discussions ICD recipients and healthcare professionals avoided discussions about deactivation Table 149: Finding 3: Decision making Sub-finding Statement of sub-finding Healthcare professionals decide People with ICDs felt that healthcare professionals should decide whether or not a device should be deactivated Patients decide Healthcare professionals felt that patients should decide when to deactivate their device. 10.3.3.3.1 Narrative summary of review findings Finding 1: Attitudes and understanding Review sub-finding 1: Awareness Many ICD recipients and family members were not aware that ICDs could be deactivated. Their doctors had not discussed this with them, and they had not thought about the issues related to end of life care. Finding this out came as a surprise for many, and they reported that thoughts about dying were not discussed between them, their spouses and their healthcare professionals.


Finding this out came as a surprise for many, and they reported that thoughts about dying were not discussed between them, their spouses and their healthcare professionals. Others reported that they only thought a device would be deactivated in cases where it needed to be changed; the battery had run out, if they had an infection or an MRI was required. Some reported that their clinician may have told them in passing about end of life care and deactivation issues, although they didn t feel that this was fully discussed. Explanation of quality assessment: moderate methodological limitations in the studies contributing to this sub-finding; minor concerns about the coherence of the finding; partial relevance due to the contributing studies being conducted outside of the UK; minor concerns about inadequacy as the evidence provided reasonable depth. There was an overall judgement of low confidence in this sub- finding due to the concerns regarding the methodological limitations and relevance. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Review sub-finding 2: Misconception Some people perceived ICD deactivation to be equivalent to euthanasia or assisted suicide, with some believing that it would lead to immediate death. In these cases they reported only wanting to consider deactivation when they were brain dead . They felt that a cardiac arrest was a threat to their lives, and healthcare professionals were obligated to treat them. Some patients also said that they would never want their ICD to be deactivated because this was the equivalent to suicide and therefore against their faith.


Some patients also said that they would never want their ICD to be deactivated because this was the equivalent to suicide and therefore against their faith. Explanation of quality assessment: moderate methodological limitations in the studies contributing to this sub-finding; minor concerns about the coherence of the finding; partial relevance due to the contributing studies being conducted outside of the UK; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth. There was an overall judgement of very low confidence in this sub-finding due to the concerns regarding the methodological limitations, relevance and adequacy. Review sub-finding 3: Not wanting to deactivate Some people would not consider living without their ICD because they believed it was keeping them alive. Some felt that the ICD should always be replaced when the batteries ran out, regardless of other circumstances. They also described that they would chose life at all costs and would not want to deactivate their ICD when it could extend life. Others were also scared to deactivate their device. Some ICD recipients could not identify any situations in which they would chose to deactivate their device, describing this as a no win situation . Explanation of quality assessment: moderate methodological limitations in the studies contributing to this sub-finding; moderate concerns about the coherence of the findings due to conflicting reports regarding patients and family members wanting to deactivate their device; partial relevance due to the contributing studies being conducted outside of the UK; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth. There was an overall judgement of very low confidence in this sub-finding due to the concerns regarding the methodological limitations, relevance and adequacy.


There was an overall judgement of very low confidence in this sub-finding due to the concerns regarding the methodological limitations, relevance and adequacy. Review sub-finding 4: Wanting to deactivate Some ICD recipients felt that they would only deactivate their device when their quality of life was so low that they were bedridden or unable to engage in daily activities. They felt that if they had no hope of a meaningful recovery and were at a terminal point of their illness, then they would want to deactivate their device. They also felt that if they were in a lot of pain and had had numerous shocks than they might want to deactivate their device. Other elderly patients had been seeking information about whether they could refuse an ICD replacement, feeling that they might be ready to die soon; although they had not discussed these thoughts with loved ones or healthcare professionals. Family members felt that they would only agree to deactivate the ICD if all hope was gone and their partner no longer had a 'worthy' life. Many expressed that they would not want their partner to suffer and be in pain in their last days of life, which an active ICD could cause. In these cases, they felt there was no reason to prolong the inevitable and cause extra suffering by keeping an ICD going. Similarly, some doctors agreed and in these situations did not feel like they were killing the patient. Nurses also supported deactivation when the patient had been well informed. They reported that this often would happen when patients were undergoing withdrawal of other life-sustaining treatments, and was done to improve patient comfort and avoid ongoing shocks. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights.


Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Explanation of quality assessment: moderate methodological limitations in the studies contributing to this sub-finding; moderate concerns about coherence due to a conflicting sub-finding on patients and family members not wanting to deactivate their device; partial relevance due to the contributing studies being conducted outside of the UK and one of the studies discussing implantation devices other than just ICDs; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth. There was an overall judgement of very low confidence in this sub- finding due to the concerns regarding the methodological limitations, relevance and adequacy. Finding 2: Discussions Review sub-finding 5: Initiating the conversation Some ICD recipients felt that discussions should be initiated by a healthcare professional such as a cardiologist, nurse or social worker. Others felt that healthcare professionals initiating conversations about ICD deactivation would be too emotionally distressing. Nurses felt that they were often the ones to bring up the conversation with the family during the dying process when the family started to ask 'why is it taking so long'. Doctors felt that ICD discussions were important but guidelines on how to initiate the conversation were unclear. Explanation of quality assessment: minor methodological limitations in the studies contributing to this sub-finding; minor concerns about the coherence of the sub-finding; partial relevance due to the contributing studies being conducted outside of the UK; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth. There was an overall judgement of low confidence in this sub-finding due to the concerns regarding relevance and adequacy.


There was an overall judgement of low confidence in this sub-finding due to the concerns regarding relevance and adequacy. Review sub-finding 6: Starting the conversation early Some ICD recipients felt that discussions should be initiated early. They felt it should be pre-implant and while they were still cognitively intact ; many felt that at this time they wanted the issue to be described to them fully, so that they were aware of the issues around deactivation but did not have to make any decisions at that point. Patients did not feel it was appropriate to have discussions about ICD deactivation at the end of life when death was imminent. They also highlighted the role of healthcare professionals in allowing them to make a fully informed decision about ICD implantation. They suggested they could be given written information. Those that had already had this discussion said it was good to do this early while they were already engaged in ICD discussions with their healthcare professionals, and some that hadn't had the conversation felt that they wanted to do so soon. Healthcare professionals felt that deactivating ICDs was unlike any other decisions they had to make, and so it was difficult for them to know when discussions should take place. They felt that ICD deactivation was not discussed early enough, which meant devices were not deactivated in time. They also felt there was a lack of forward planning in the community. Others felt that discussions did take place upon insertion but these are usually forgotten by the time they come into focus when the person s condition has deteriorated.


Others felt that discussions did take place upon insertion but these are usually forgotten by the time they come into focus when the person s condition has deteriorated. Explanation of quality assessment: minor methodological limitations in the studies contributing to this sub-finding; moderate concerns about the coherence of the sub-finding due to a conflicting review on having the conversation later ; partial relevance due to most of the studies being conducted outside of the UK; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth. There was an overall judgement of low confidence in this sub-finding due to the concerns regarding relevance, adequacy and coherence. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Review sub-finding 7: Having the conversation later Some ICD recipients felt that ICD deactivation should be discussed if there was a change in their condition, and if their condition had deteriorated. They felt that patients should be of sound mind but had definitely progressed to 'end of life'. Patients felt that physicians could predict when this change could result in death, and that ICD deactivation should be discussed as a reminder of the options and to determine preferences. Similarly, other patients felt that discussions of deactivation should not happen at the time of insertion. This is because of the emotional distress it would cause, and how overwhelming the information would be.


This is because of the emotional distress it would cause, and how overwhelming the information would be. Others felt that it did not make sense to begin discussions of removing a device before even implanting it Explanation of quality assessment: minor methodological limitations in the studies contributing to this sub-finding; moderate concerns about the coherence of the sub-finding due to a conflicting review on starting the conversation early ; partial relevance due to the contributing study being conducted outside of the UK; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth. There was an overall judgement of very low confidence in this sub-finding due to the concerns regarding relevance, adequacy and coherence. Review sub-finding 8: Avoiding discussions Healthcare professionals, ICD recipients and family members all avoided discussions about ICD deactivation, due to the difficult nature of the conversations. Some patients said that they had brief conversations with their healthcare professionals but did not discuss this further with their family members. Others were putting off talking about it because they felt that end of life issues were not relevant to the current phase of their life and were not yet a reality; they wanted to think about this nearer the time. In 1 study, ICD recipients were not willing to discuss deactivation in the focus group. Doctors reported that they rarely had discussions about ICD deactivation, even though they acknowledged the importance of doing so. They found that at a technical level it crossed their mind that it should be switched off, but that for some it wouldn't cross their mind to initiate a conversation with the patient.


They found that at a technical level it crossed their mind that it should be switched off, but that for some it wouldn't cross their mind to initiate a conversation with the patient. Doctors reported that it was hard to bring up discussions about deactivation because this contrasted so much with their discussions about the primary lifesaving role of the devices, and therefore initiating discussions of deactivation felt as though they were shutting off hope for patients. Others also didn t feel like they could bring up such a difficult topic if they didn t have a good relationship or rapport with the patient. Similarly nurses felt that doctors were uncomfortable having discussions about end of life issues because they are not trained to manage these situations. Healthcare professionals felt that in particular cardiology teams were reluctant to take the lead on decision-making. Some healthcare professionals also felt that electrophysiology services were unwilling to have conversations and make decisions regarding deactivation. Explanation of quality assessment: moderate methodological limitations in the studies contributing to this sub-finding; minor concerns about the coherence; partial relevance due to most of the contributing studies being conducted outside of the UK; minor concerns about inadequacy as the evidence provided reasonable depth. There was an overall judgement of moderate confidence in this sub-finding due to the concerns regarding the methodological limitations and relevance. Finding 3: Decision making Review sub-finding 9: Healthcare professionals decide People with ICDs wanted to put the decision to deactivate their ICD in the hands of healthcare professionals rather than making an active choice themselves about deactivation.


Finding 3: Decision making Review sub-finding 9: Healthcare professionals decide People with ICDs wanted to put the decision to deactivate their ICD in the hands of healthcare professionals rather than making an active choice themselves about deactivation. They felt that it was difficult for them to make a decision themselves because they weren t qualified and that clinicians should come up with the suggestion themselves; they trusted the decisions that their Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 healthcare professionals made. Spouses also felt that they would rather healthcare professionals make decisions about deactivation so they did not have to make the decisions themselves. Healthcare professionals reported reasons they were unable to deactivate ICDs, even if they had decided to deactivate. For example, deactivation was often not possible out of hours, when staff or magnets were unavailable in community hospitals. Some healthcare professionals found that consultants were unavailable to visit dying patients in the community in order to deactivate ICDs. Others spoke of excessive time delays due to a lack of defined process in the community, unavailability of magnets or insufficient education on how to use magnets and confusion of the size of the magnet needed. Others spoke of organisational difficulties, having to make lots of phone calls in order to access technician support for deactivation. Many felt that there was no local or national policy or procedures related to ICD deactivation, which made the process long and difficult. Explanation of quality assessment: moderate methodological limitations in the contributing studies; minor concerns about the coherence with nothing to lower confidence; partial relevance due to the contributing studies being conducted outside of the UK; minor concerns about inadequacy as the evidence provided reasonable depth.


Explanation of quality assessment: moderate methodological limitations in the contributing studies; minor concerns about the coherence with nothing to lower confidence; partial relevance due to the contributing studies being conducted outside of the UK; minor concerns about inadequacy as the evidence provided reasonable depth. There was an overall judgement of moderate confidence in this sub-finding due to the concerns regarding methodological limitations and relevance. Review sub-finding 10: Patients decide Healthcare professionals felt that 'competent' ICD recipients should decide whether to deactivate their device. They highlighted the importance of discussions with the person and family, and felt that all cardiologists considering implanting a device should have an end of life discussion. Patients reported that the frequency and pain of shocks, overall quality of life and recommendations of the physician could impact their decision. Nurses felt that families sometimes put pressure on patients to get a device or to keep a device active. Explanation of quality assessment: moderate methodological limitations in the studies contributing to this sub-finding; minor concerns about the coherence; partial relevance due to the contributing studies being conducted outside of the UK; moderate concerns about inadequacy as there was a relatively small amount of evidence which lacked depth There was an overall judgement of very low confidence in this sub-finding due to the concerns regarding methodological limitations, relevance and adequacy. Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 10.3.3.4 Qualitative evidence summary Finding 1: Attitudes and understanding Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Awareness focus groups USA, 2 Canada ICD recipients and family members were unaware that ICDs could be deactivated.


ISBN: 10.3.3.4 Qualitative evidence summary Finding 1: Attitudes and understanding Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Awareness focus groups USA, 2 Canada ICD recipients and family members were unaware that ICDs could be deactivated. Limitations Moderate concerns about methodological limitations LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Minor concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Misconception USA, 1 Canada People perceived deactivation to be equivalent to euthanasia or suicide, resulting in immediate death Limitations Moderate concerns about methodological limitations VERY LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Not wanting to deactivate USA People did not want to deactivate regardless of the circumstances Limitations Moderate concerns about methodological limitations VERY LOW Coherence Moderate concerns about coherence Relevance Moderate concerns Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights.


ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Misconception USA, 1 Canada People perceived deactivation to be equivalent to euthanasia or suicide, resulting in immediate death Limitations Moderate concerns about methodological limitations VERY LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Not wanting to deactivate USA People did not want to deactivate regardless of the circumstances Limitations Moderate concerns about methodological limitations VERY LOW Coherence Moderate concerns about coherence Relevance Moderate concerns Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Wanting to deactivate focus groups Denmark People wanted to deactivate when they were bedridden with an extremely low quality of life Limitations Moderate concerns about methodological limitations VERY LOW Coherence Moderate concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Finding 2: Discussions Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights.


ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Wanting to deactivate focus groups Denmark People wanted to deactivate when they were bedridden with an extremely low quality of life Limitations Moderate concerns about methodological limitations VERY LOW Coherence Moderate concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Finding 2: Discussions Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Initiating the conversation USA Focus groups Some patients felt that healthcare professionals should start the conversation, whereas others felt that this would be emotionally distressing Limitations Minor concerns about methodological limitations LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Starting the conversation early Canada Interviews Some felt that discussions should be started early while they were able to make decisions Limitations Minor concerns about methodological limitations LOW Coherence Moderate concerns about coherence Relevance Moderate concerns Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights.


ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Initiating the conversation USA Focus groups Some patients felt that healthcare professionals should start the conversation, whereas others felt that this would be emotionally distressing Limitations Minor concerns about methodological limitations LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Starting the conversation early Canada Interviews Some felt that discussions should be started early while they were able to make decisions Limitations Minor concerns about methodological limitations LOW Coherence Moderate concerns about coherence Relevance Moderate concerns Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Having the conversation later Interviews Some felt discussions should occur later on or when there was a change in their condition Limitations Minor concerns about methodological limitations VERY LOW Coherence Moderate concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights.


ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Having the conversation later Interviews Some felt discussions should occur later on or when there was a change in their condition Limitations Minor concerns about methodological limitations VERY LOW Coherence Moderate concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Study design and sample size Finding Quality assessment Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Avoiding discussions focus groups USA, 1 UK ICD recipients and healthcare professionals avoided discussions about deactivation Limitations Moderate concerns about methodological limitations LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Minor concerns about adequacy Finding 3: Decision making Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Healthcare professionals decide USA, 1 Canada People with ICDs felt that healthcare professionals should decide whether or not a device should be deactivated Limitations Moderate concerns about methodological limitations LOW Coherence Minor concerns about coherence Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights.


ISBN: Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Avoiding discussions focus groups USA, 1 UK ICD recipients and healthcare professionals avoided discussions about deactivation Limitations Moderate concerns about methodological limitations LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Minor concerns about adequacy Finding 3: Decision making Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Healthcare professionals decide USA, 1 Canada People with ICDs felt that healthcare professionals should decide whether or not a device should be deactivated Limitations Moderate concerns about methodological limitations LOW Coherence Minor concerns about coherence Advanced heart failure and palliative care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Relevance Moderate concerns about relevance Adequacy Minor concerns about adequacy Study design and sample size Finding Quality assessment Number of studies contributing to the finding Design Criteria Rating Overall assessment of confidence Patients decide focus groups Canada Healthcare professionals felt that patients should make the decision. Limitations Moderate concerns about methodological limitations VERY LOW Coherence Minor concerns about coherence Relevance Moderate concerns about relevance Adequacy Moderate concerns about adequacy Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 10.3.4 Economic evidence The committee agreed that health economic studies would not be relevant to this review question, and so health economic evidence relating to this question was not sought. Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights.


Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 10.3.5 Evidence statements Qualitative See the narrative summaries of the review findings in section 1.3.3.1. Economic Health economic studies were not sought for this review question. 10.3.6 Recommendations and link to evidence Recommendations If it is thought that a person may be entering the last 2 to 3 days of life, follow the NICE guideline on care of dying adults in the last days of life. See NICE s technology appraisal guidance on implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure. When discussing implantation of a cardioverter defibrillator: explain the risks, benefits and consequences of cardioverter defibrillator implantation, following the principles on shared decision making in the NICE guideline on patient experience in adult NHS services ensure the person knows that the defibrillator can be deactivated without affecting any cardiac resynchronisation or pacing, and reactivated later explain the circumstances in which deactivation might be offered discuss and dispel common misconceptions about the function of the device and the consequences of deactivation provide the person and, if they wish, their family or carers with written information covering the information discussed. [2018] Review the benefits and potential harms of a cardioverter defibrillator remaining active in a person with heart failure: at each 6-monthly review of their heart failure care whenever their care goals change as part of advance care planning if it is thought they are nearing the end of life. [2018] Findings identified in the evidence synthesis The evidence from the review was grouped into 3 findings, each of which contained multiple sub-findings. These key findings are summarised below.


[2018] Findings identified in the evidence synthesis The evidence from the review was grouped into 3 findings, each of which contained multiple sub-findings. These key findings are summarised below. Attitudes and understanding: many ICD recipients were not aware that their ICDs could be deactivated, with their doctors not discussing this with them. Other recipients had misconceptions about the effect of deactivation, perceiving it to be equivalent to euthanasia or assisted suicide, leading to immediate death. Whether ICD recipients would consider deactivation or not was highly varied. Some recipients reported that they would not consider living without their ICD as they believed it was keeping them alive. Similarly, some recipients felt that their ICD should never be deactivated when it could Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 extend their life, regardless of the circumstances. Some people were scared to deactivate. Other ICD recipients felt that they would deactivate their device when their quality of life was so low that they were bedridden or unable to engage in daily activities, if they were in a lot of pain and had received numerous shocks, or if they were elderly and felt they may be ready to die soon. Some family members and healthcare professionals reported similar sentiments about deactivation being appropriate in these circumstances. Discussions: preferences and experiences on initiating the conversation about deactivation were varied. Some ICD recipients felt that healthcare professionals should initiate the discussion, whereas others felt this would be too emotionally distressing. Nurses felt they were often the ones to raise the conversation during the dying process. Doctors reported that guidelines on how to initiate the conversation were unclear. Preferences about the timing of the discussion were also varied.


Preferences about the timing of the discussion were also varied. Some ICD recipients felt that discussions should be initiated early, pre-implant, as part of the informed consent process, rather than having the discussions at the end of life when death was imminent. Other ICD recipients felt that ICD deactivation should be discussed if their condition had deteriorated significantly and they were nearing the end of their life, with some specifically expressing views that deactivation not be raised at the time of implantation due to the resulting emotional distress and overwhelming nature of the information. Healthcare professionals reported that it was difficult for them to know when these discussions should take place. Some felt that it was often not discussed early enough which delayed deactivation occurring; others reported that discussions taking place at the time of implantation are usually forgotten by the time they become relevant; when a person s condition deteriorates. ICD recipients, family members and healthcare professionals all reported avoiding discussions about ICD deactivation, due to the difficult nature of the conversations. Decision making: there was a dichotomy in the evidence on who should decide whether an ICD should be deactivated. People with ICDs and their family members often felt that healthcare professionals should decide whether it was appropriate for their ICD to be deactivated, as they did not feel qualified or comfortable making the decision themselves. Healthcare professionals felt that ICD recipients should be the ones to decide whether to deactivate their device in the context of end of life discussions. Some healthcare professionals felt that families sometimes put pressure on patients to keep their device active. Healthcare professionals reported practical challenges in the deactivation of ICDs after a decision had been made.


Healthcare professionals reported practical challenges in the deactivation of ICDs after a decision had been made. Issues were experienced out of hours and in the community or community hospitals where staff or magnets were not available. Lack of a clear process and understanding about how deactivation worked in the community, and organisational issues, were also reported as making the process long and difficult. Quality of the evidence The decsions around discussing deactivation was considered to be similiar in all populations and the committee agreed to include studies outsideof the UK. The confidence ratings for the different sub-findings in the review were Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 varied, ranging from moderate to very low. The committee weighed the confidence in the individual findings with their own experiences, and agreed that they were broadly consistent, despite much of the evidence being downgraded in confidence due to being conducted outside of the UK in settings that differed to varying degrees from the English NHS. Attitudes and understanding: 3 of the 4 sub-findings within this finding were rated very low confidence, with the fourth rated low confidence. All of the sub-findings were downgraded due to concerns about methodological limitations and relevance, with some also being downgraded for concerns about coherence and/or adequacy. Discussions: 2 of the 3 sub-findings within this finding were rated low confidence, with the third rated very low confidence. All were downgraded for relevance and adequacy, with one also downgraded for coherence. Decision making: the sub-finding that patients felt that healthcare professionals should decide about deactivation was rated moderate confidence, with the only downgrade being for relevance.


Decision making: the sub-finding that patients felt that healthcare professionals should decide about deactivation was rated moderate confidence, with the only downgrade being for relevance. The second sub- finding that healthcare professionals felt that patients should decide about deactivation was rated very low confidence due to concerns about methodological limitations, relevance and adequacy. Trade-off between benefits and harms The committee agreed that the findings and sub-findings identified in the review resonated with their own experiences as healthcare professionals or lay members connected to heart failure services in the NHS. The committee acknowledged that some of the sub-findings identified in the review reflect general issues around communication and information needs in health care and are addressed by recommendations in the patient experience guideline CG138. The committee decided to focus on the issues raised that are specific to the deactivation of ICDs in heart failure. The committee discussed the review finding about discussing ICD deactivation. The committee agreed that deactivation should be explained and discussed pre-implantation. Although some patients may not want this information at the time of implantation, it is a necessary part of shared decision making and informed consent process. The committee agreed to make a recommendation to emphasise the importance of deactivation being discussed at this stage, and outlined some of the key issues that should be covered in that discussion, including: the risks, benefits and consequences of implantation, the process of deactivation and the circumstances in which deactivation may be appropriate, including the potential harms of not deactivating, the possibility of partial deactivation of the ICD without deactivating the Cardiac Resynchronisation Therapy component (in the patients with CRT-D devices) the possibility of reactivation if the person s condition changes or improves common misconceptions about the function of an ICD and the consequences of deactivation.


The committee agreed to make a recommendation to emphasise the importance of deactivation being discussed at this stage, and outlined some of the key issues that should be covered in that discussion, including: the risks, benefits and consequences of implantation, the process of deactivation and the circumstances in which deactivation may be appropriate, including the potential harms of not deactivating, the possibility of partial deactivation of the ICD without deactivating the Cardiac Resynchronisation Therapy component (in the patients with CRT-D devices) the possibility of reactivation if the person s condition changes or improves common misconceptions about the function of an ICD and the consequences of deactivation. In line with the review findings, the committee agreed that the discussion should be followed up with written information so the person and their Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 family had time to digest the information and make an informed decision. The committee noted in the review findings that discussions about deactivation occurring at the time of implantation were often forgotten by the time they became relevant, that discussions were avoided by all parties, and that they were often held too late, causing delays in deactivation and potential unnecessary harm. The committee agreed that the possibility of deactivation should be revisited regularly by healthcare professionals caring for that person. The committee decided that the appropriateness of continuing the ICD should be considered by the person s health care team at each 6 monthly review of their heart failure. This did not mean that a conversation had to take place with the patient about deactivation at each 6 monthly review, but it was important that the healthcare professional considered it.


This did not mean that a conversation had to take place with the patient about deactivation at each 6 monthly review, but it was important that the healthcare professional considered it. Healthcare professionals should consider discussing with the person their goals of ongoing treatment and whether the ICD remains in line with those goals, as part of general advanced care planning. This may be appropriate where the symptoms of a person with heart failure have deteriorated over a period of time despite optimal treatment, people whose care goals are changing, in very elderly people, and with people thought to be nearing the end of their life. The committee acknowledged that these reviews and conversations may be led by primary care services, for example, in circumstances where the person s heart failure is stable but they are of advanced age and general advanced care planning is applicable. Alternatively, they may take place in the specialist heart failure MDT if the person s heart failure is severe or the person is otherwise high risk and being managed by the specialist team. All health care professionals caring for patients with heart failure should be prepared and equipped to raise these issues with ICD recipients. The committee noted that specific issues were relevant where a person was thought to be entering their last days of life. The committee wished to emphasise the importance of health care professionals following the guidance in the Care of the dying adult guideline in these circumstances. The committee discussed the issues raised by the review around the logistical challenges of deactivation, many of which came from a UK based study.


The committee discussed the issues raised by the review around the logistical challenges of deactivation, many of which came from a UK based study. While the committee felt that these challenges strongly resonated with their experiences of deactivation in the NHS context; commissioning, service delivery and service design issues are outside the scope of this guideline and so the committee was unable to make recommendations in this area. The committee emphasised the importance of any service that provides ICDs having services available to support the whole process from implantation to deactivation. Trade-off between net clinical effects and costs Economic studies were not sought for this review question. The committee considered that the recommendations made above represent best clinical practice and provide essential information to individuals to allow for shared decision making. If patients are well informed this could result in improved quality of life, due to a reduction in anxiety about the implantation, and potential future deactivation, not only for the patient but also their families and/or carers. Furthermore, informed decision making could reduce the number of painful unwanted shocks for individuals, again potentially providing some improvement in quality of life. The committee Chronic Heart Failure Advanced heart failure and palliative care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 acknowledged that there is likely to be a cost associated with providing written information for the patient and their family and/or carers. Some information on ICDs is already available from charitable organisations and some clinics already provide such information to their patients. Readily available information could be edited, or further supplementary information could be provided if not all aspects are covered from available materials.