MDT clinic: multidisciplinary teams forming an outpatient clinic Nurse-led or pharmacist-led clinic: enhanced outpatient service with MDT working Case-management: active management of high-risk people with case managers taking responsibility for caseloads working in an integrated care system.326 Given the heterogeneous nature of the interventions and populations in the included studies, a number of additional tables have been included in this evidence report to summarise the key features of the included studies. Table 98 shows the included studies listed alphabetically with their population risk and length of intervention stratification, as well as their intervention strand. Table 99 lists the included studies by strata and provides details of the methods for each study. Table 100 expands on the population risk stratification for each study. Table 101 gives more information on the composition of the MDT involved in the intervention arm of each study. Table 102 gives more information on the intervention delivered, and on the usual care arm. Evidence from the studies is summarised in the clinical evidence summaries below (Table 103-123). No meta-analysis was conducted due to the heterogeneity in study and intervention designs; a separate evidence summary is provided for each study. Studies are grouped by the strata identified in Table 99. Table 98: List of studies included in the review Study Population risk strand Length strand Intervention strand Low Long Nurse-led clinic Aukland-HF trial High Long MDT clinic High Long Case management High Long MDT clinic COACH trial , Postmus 2011272 , , Jaarsma 2002158 ) High Long Basic: Nurse-led clinic Intensive: Home-based MDT DEAL-HF trial De la Porte 2007 87 High Long MDT clinic Del sindaco 200791 Del sindaco 201290 ) High Long MDT clinic High Mid Nurse-led clinic High Mid MDT clinic High Mid Nurse-led clinic High Mid MDT clinic HICMan trial Low Long Case-management Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Population risk strand Length strand Intervention strand J-HOMECARE trial ) High Mid Case management ) High Short MDT clinic Low Long Case-management NorthStar trial Low Long MDT clinic High Mid MDT clinic OPTIMAL trial High Long Nurse-led clinic PREFER trial High Mid Home-based MDT PRICE trial High Long MDT clinic High Short MDT clinic Low Long MDT clinic: pharmacist-led Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 99: Study details (arranged by strata) First Author / Trial name n. Country Recruitment HFRE F or both Start s inpat ient QoL Outcomes: Mort/ Hosp Meds Length (months ) Last measure (months ) Face-to- face meeting s High Risk - Short interventions 98 Ireland Inpatients admitted with primary diagnosis HF both Yes Deaths, Admissions outpt 112 UK Patients that had been referred by GP for open access echo due to suspected HF, who had confirmed LVSD both No Death, Admissions High Risk - Mid-length interventions PREFER trial 72 Sweden Outpatients at geriatrics dept or PC with NYHA III-IV plus one of five markers of need for palliation both No EQ-5D (appears to be VAS) Deaths, Admissions 28 Australia Patients with HFREF from clinic for complex heart failure patients on sub- maximal medication doses HFRE F No MLWHF Death, Admissions 230 Canada Seen in ED or admitted with primary diagnosis HF Most HFRE F On dc Deaths, admissions Sweden Inpatients aged >65y screened for HF, NYHA III-IV both On dc Change in NYHA Death, Admission Gonzalez-Guerrero 117 Spain Admitted under geriatric department with acute HF both Yes Death or admission J-HOMECARE trial Tsuchihashi-makaya 168 Japan From cardiology hospital both Yes SF-8 Deaths, Admissions Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name n. Country Recruitment HFRE F or both Start s inpat ient QoL Outcomes: Mort/ Hosp Meds Length (months ) Last measure (months ) Face-to- face meeting s 200 Italy Inpatients <86y screened for congestive HF both Yes MLWHF Deaths, Admissions outpt High Risk - Long interventions Auckland-HF Zealand Admitted with HF both On dc MLWHF Q Deaths. Admissions mandate d GP visits) 186 Austria Hospitalised and signs/symptoms of HFREF HFRE F On dc Death, Admissions 234 Italy Patients in inpatient Heart Failure Unit, CHF and HFRE F On dc Time trade-off / Utility Cardiac death, Admissions Px 12 (ave.) 12 mean attend COACH trial - basic s Patients admitted to hospital (experienced HF centres) with signs and symptoms of HF for which hospitalisation was considered necessary NYHA II-IV, stabilised before entry to study both Yes NR Deaths, Admissions COACH Jaarsma - enhanced s Patients admitted to hospital (experienced HF centres) with signs and symptoms of HF for which hospitalisation was considered necessary NYHA II-IV, stabilised before entry to study both Yes NR Deaths, Admissions phone) DEAL-HF trial De la s Inpatients and cardiology outpatients recruited, NYHA both No SF-36* MLWHF* Death, Days in hospital Px* Creat- Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name n. Country Recruitment HFRE F or both Start s inpat ient QoL Outcomes: Mort/ Hosp Meds Length (months ) Last measure (months ) Face-to- face meeting s III-IV inine Del sindaco 200791 173 Italy Hospitalised, aged 70 or more, and discharged home. NYHA III-IV and required IV diuretics both On dc Deaths, Admissions OPTIMAL trial 208 Sweden Patients hospitalised with heart failure with NYHA II-IV and LV systolic dysfunction both On dc Nottingh am Health Profile Death, Admissions Px flex 6- Ave 37 mean attend PRICE trial Atienza 153 Spain Cardiology ward with diagnosis of primary HF both Yes MLWHF Q Deaths, Admissions Low risk (stable HF) Long interventions 160 Sweden Patients recruited from PC with CHF and LVEF<50% HFRE F No SF-36* Death, Admissions HICMan trial 197 Germany Patients recruited from PC with hospital admission with HF in last two years, objective CHF and LVEF<45% HFRE F KCCQ Death, Admissions 153 Sweden Recruited from PC, NYHA II-IV both No SF-36* Death Px 12 12 mean Northstar trial 921 Denmark Stable CHF on optimal meds, HFRE F No MLWHF Death, Admissions Px, Adv. effects 83 UK Elderly patients recruited from inpatient or outpatient with diagnosis CHF both No SF-36* MLWHF Death, Admissions Adher- ence *reported incompletely, therefore not included in analysis NR: measured but not reported Px: prescription of ACEi+/beta-blocker+/MRA dc: on discahrge Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 100: Papers according to population risk: risk strata and background rate of admission (IQR 0.6-1.6, values outside IQR are highlighted) Risk strata (proportions are estimates) First Author / Trial name New dxa ADHFb Severec Req. titrationd Other Overall risk category Admissions/pt/year in control High Risk - Short interventions 46% All NS None ADHF 1.0 All None 45% Most New 1.0 High Risk - Mid-length interventions PREFER trial Brannstrom 2014 50 None NS All None suitable for palliative care Severe 2.9 (high) None None 20% All from clinic for "complex HF" Titration 0.5 (low) NS 90% mean NYHA patients ADHF 2.4 (high) 40% All NS 60% from geriatric ward (ave J-HOMECARE trial Tsuchihashi-makaya 2013341 NS All 5% 50% ADHF NS High Risk - Long interventions Auckland-HF Doughty 2002103 NS All All 10% ADHF 1.6 NS All All 25% ADHF NS NS All 35% None ADHF 0.6 COACH trial Jaarsma 2008157 - basic NS All 50% 35% ADHF 0.7 Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Risk strata (proportions are estimates) COACH Jaarsma 2008157 - enhanced NS All 50% 35% ADHF 0.7 DEAL-HF trial De la Porte 2007 87 NS 30% All 30% Severe NS Del sindaco 200791 NS All 60% 50% Older patients ADHF NS OPTIMAL trial Mejhert 2004 220 PRICE trial Atienza 200422 NS All 90% NS ADHF 0.5 (low) Low Risk (stable HF) - Long interventions NS NS 35% 25% Nil low risk 0.6 HICMan trial Peters-klimm 2010 257 None 25% 30% 25% Nil low risk 0.4 (low) None NS 50% 40% Nil low risk NS Northstar trial Schou 2013 300 None None 11% None Nil low risk 0.8 NS 25% mean NYHA NS Older patients Nil low risk 0.7 (a) New dx = identified as new diagnosis of heart failure at recruitment. (b) ADHF = Acute decompensated heart failure risk strata signifying recent decompensation, defined by selection to study due to visit to emergency dept or inpatient admission due to heart failure, with or without congestion. (c) Severe = proportion NYHA III-IV at baseline (note that if recruited while decompensated, this may be higher than their chronic severity). (d) Req. titration = Requiring medication titration, device implantation or surgical intervention if not stated, this was estimated by looking at baseline medication NS = not stated in study paper Table 101: Professions / Competencies delivering interventions (studies arranged by strata) First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details High Risk - Short interventions Ledwidge HF nurse Y Education from nurse and dietician in hospital, followed by telephone contact weekly for 12 weeks by HF nurse specialist. Appts at clinic after 2 and 6 Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details weeks (unclear composition of clinic) Cardiologist Cardiac nurse MDT High Risk - Mid-length interventions PREFER trial Brannstrom Cardiologist + Palliative care physician HF nurse + Palliative care nurse Y Y HF team plus palliative nurse + palliative physician Cardiologist Cardiac nurse Nurse-led clinic in consultation with cardiologist, could make onward referrals to other professionals Cardiologist HF nurse Y Y Y Specialist HF clinic for 6 months, contact within 72h discharge and monthly visits Cardiologist HF nurse Y Physician Nurse-run clinic in cooperation with doctors, communication with PC and social care Gonzalez- Geriatrician Cardiac nurse Assessment prior to d/c, at 10d, 1m and 6m post d/c by the 'team', plus t/c contact 48h post-d/c (nurse) and 3/12 (geriatrician) J-HOMECARE trial Tsuchihashi- Cardiologist Cardiac nurse Y Y Y Nurse CM in liaison with MDT for 6 months Cardiologist Cardiac nurse Pre-discharge education by experienced cardiovascular nurse, thereafter, contact with nurse to reinforce message. Face-to- face meetings with a doctor and nurse three times in next six months High Risk - Long interventions Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details Auckland-HF Cardiologist Cardiac nurse Physician Explicit partnership with primary and secondary care, involving individualised and group education, scheduled visits to clinic (unclear composition) and GP and drug titration Cardiologist HF nurse CHF specialist nurse carried out home visits according to a schedule, or more if deterioration. Also scheduled medical reviews, with extra at request of nurse Cardiologist HF nurse Y Y Y Y MDT COACH trial - basic Cardiologist HF nurse Basic: additional visits with HF nurse at outpatient clinic, education protocol given. COACH Jaarsma - enhanced Cardiologist HF nurse Y Y Y Intensive: weekly telephone calls after d/c, home visit by HF nurse, home visit from MDT and monthly contact. DEAL-HF trial De Cardiologist HF nurse Y MDT Del sindaco Cardiologist HF nurse Cardiologist case-managed, with support from nurse who made regular telephone calls OPTIMAL trial Cardiologist Cardiac nurse Nurse-led clinic (under supervision of cardiologist) PRICE trial Cardiologist HF nurse Formal education package delivered prior to d/c, detailing self-care, with 3/12 opt appts to optimise medical therapy and reinforce self-care messages. Unclear MDT composition Low Risk (stable HF) - Long interventions Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details HF nurse Physician Specialist HF nurse working in liaison with GP HICMan trial Peters-klimm For training primary care For training primary care Practice nurse and Physician Case management by practice nurse with 1.5 day specific extra training in case management of patients with heart failure according to a clinical practice guideline. Nurse worked with primary care physician Martensson For training primary care For training primary care Practice nurse and Physician Training provided to all practice nurses and half of physicians 3x3h sessions on pathophysiology of HF, evaluation and treatment of HF, and self-management. Upskilled practice nurse delivers self-care intervention Northstar trial Cardiologist HF nurse MDT, composition unclear Cardiologist Y Pharmacist care to encourage self-care and self-monitoring Table 102: Key activities of MDT, studies arranged by strata First Author / Trial name Meds optimisatio n Deliver DMPa Deterioration management Other Intensity (ave no. patient-professional encounters) Usual care High Risk - Short interventions Y To contact clinic, where given protocol-driven advice on increasing diuretic Carer participation in education Fixed face-to-face 3x in hospital + 2x outpatient, plus telephone Primary care, with referral to cardiology at discretion Y Contact number given min. 2 face-to-face Primary care Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Meds optimisatio n Deliver DMPa Deterioration management Other Intensity (ave no. patient-professional encounters) Usual care High Risk - Mid-length interventions PREFER trial IV and SC medication, plus some investigations, could be done at home regular multi- disciplinary meetings, "person-centred care at home" model min. 1 face-to-face, actual mean 20 Primary care +/- additional measures as usual Y specifically titration of beta-blocker min. 3 face-to-face Primary care +/- other services as usual Y Given telephone number to contact during business hours. Could receive assessment and IV diuretics if needed at the clinic Actual ave 6 face-to-face Follow-up according to decision of treating cardiologist (not MDT) Y Y Contact number given, could be reviewed and admitted directly from clinic min. 3 face-to-face, actual median 6 contacts Primary care Gonzalez-Guerrero Y Y Could contact geriatrician every morning Global therapeutic regimen evaluated according to the capacities of the patient telephone Primary care, with referral to geriatrics at discretion J-HOMECARE trial Tsuchihashi-makaya Both intervention and control groups given emergency contact methods fixed 4 face-to-face (first (next 4 months) MDT discharge education (as per intervention). Routine management by cardiologist Y Contact number to leave message Fixed 4 face-to-face, plus telephone Routine discharge information. Primary care High Risk - Long interventions Auckland-HF Doughty x Y Could contact GP or clinic, recommend GP assessment in first instance min. 7 face-to-face (including GP) Primary care with other measures as usual Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Meds optimisatio n Deliver DMPa Deterioration management Other Intensity (ave no. patient-professional encounters) Usual care Y Unclear Min. 6 face-to-face, plus telephone Primary care with other measures as usual Y Y Open access to day hospital for review and medication for decompensation without admission Tailored interventions carried out in a day hospital mean 5.5 (sd. 3.9) Cardiology clinic COACH trial Jaarsma - basic Y Basic: Encouraged to contact nurse if change 20h Cardiology opt within two months of d/c, and six- monthly thereafter COACH Jaarsma - enhanced Y Intensive: Encouraged to self- monitor and contact nurse if symptoms increased or gained weight 40h Cardiology opt within two months of d/c, and six- monthly thereafter DEAL-HF trial De la Y Y Contact number given fixed 9 face-to-face Cardiology clinic Del sindaco 200791 Y Y Given contact number Fixed 4 face-to-face, plus telephone Primary care with other measures as usual OPTIMAL trial Mejhert Y Could vary own diuretic dose min. 1 face-to-face, actual range 0-10, median 1, mean 2.2 (sd. Primary care plus personalised written HF plan, as established care in the region PRICE trial Atienza Y Y Contact HF clinic by phone if any changes Cardiology and primary care Low Risk (stable HF) - Long interventions Y Contact number given min. 2 face-to-face, 2 telephone Primary care HICMan trial Peters- Y Intensity of monitoring based on current symptoms. Patient reminders for telephone Primary care Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Meds optimisatio n Deliver DMPa Deterioration management Other Intensity (ave no. patient-professional encounters) Usual care prescriptions and appointments. Could vary own diuretic dose Education of primary care physician in both arms min. 1 face-to-face, actual mean 9.6 contacts Primary care Northstar trial Schou Y Contact number given Extended follow-up est. 24 Primary care Could vary own diuretic dose Pharmacist discusses with pt's physician about optimising meds fixed 4 face-to-face Primary care (a) DMP = Disease management programme, usually consists of structured but individualised education about HF and self-help, often including topics such as daily weights and planning for deterioration 9.2.3.1 Clinical evidence summary tables 9.2.3.1.1 High risk, Short, Home-based MDT No studies were identified in this category. 9.2.3.1.2 High risk, Short, MDT clinic Table 103: Clinical evidence summary: Ledwidge 2003: Short MDT clinic (MDTc) versus Primary +/- secondary care for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference with MDTc (95% CI) LOWa, b due to risk of bias, rate ratio (from 79 fewer to 248 fewer) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference with MDTc (95% CI) VERY LOWa, c due to risk of bias, imprecision (from 51 fewer to 213 more) 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 Downgraded by one increment for indirectness as not protocol outcome of all-cause hospitalisations c Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both Table 104: Clinical evidence summary: Rao 2007: Short MDT clinic (MDTc) versus Primary care for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTc (95% CI) MODERATEa due to imprecision Rate Ratio (from 47 fewer to 525 more) LOWa due to imprecision (from 36 fewer to 144 more) Prescribed ACE-I 112 MODERATEa due to imprecision (from 32 more to 423 more) Prescribed beta-blocker 112 HIGH peto OR (from 75 more to 467 more) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTc (95% CI) (a) Downgraded by one increment as confidence interval cross 1 MID or 2 increments as the confidence interval crosses both MID. 9.2.3.1.3 High risk, Short, Nurse-led or pharmacist-led clinic No studies were identified in this category. 9.2.3.1.4 High risk, Short, Case-management No studies were identified in this category. 9.2.3.1.5 High risk, Mid-length, Home-based MDT Table 105: Clinical evidence summary: PREFER (Brannstrom 2014): Mid-length Home-based MDT (MDThome) vs Primary +/- secondary care for high risk HF Outcomes No of Participant s (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference with MDThome HIGH rate ratio (from 736 fewer to 1237 fewer)a Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participant s (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference with MDThome LOWb due to imprecision (from 38 fewer to 562 more) Quality of life EQ-5D final score (appears to be EQ-5D visual analogue scale), higher=better. Scale from: 0 to 100. VERY LOWb, c due to risk of bias, imprecision The mean quality of life in the control groups was The mean quality of life in the intervention groups was 8.1 higher (better) (2.03 lower to 18.23 higher) (a) Manually calculated as Risk Difference above 1000. (b) Downgraded by one increment as confidence interval crossed 1 MID or 2 increments as confidence interval crossed both MIDs. (c) 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. 9.2.3.1.6 High risk, Mid-length, MDT clinic Table 106: Clinical evidence summary: Ducharme 2005: Mid-length MDT clinic (MDTc) vs Primary / secondary care for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary/sec ondary Risk difference with MDTc (95% CI) LOW a, b due to risk of bias, imprecision rate ratio 314 fewer admissions per 1000 (from 88 fewer to 481 fewer) LOWa, b (from 112 fewer to 40 more) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary/sec ondary Risk difference with MDTc (95% CI) 6 months due to risk of bias, imprecision 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 Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs (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) Downgraded by 1 increment if the confidence interval crossed 1 MID or by 2 increments if the confidence interval crossed both MIDs. Table 107: Clinical evidence summary: Gonzalez-Guerrero 2014: Mid-length MDT clinic (MDTc) vs Primary care +/- Geriatric clinic for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Control Risk difference with Gonzalez-guerrero 2014 VERY LOWa,b due to risk of bias, imprecision rate ratio (from 310 fewer to 310 more) LOWa,b due to risk of bias, imprecision (from 258 fewer to 15 more) Quality of life - not reported - - Not estimable - - (a) Downgraded by one increment as rated to be at high risk of bias (b) Downgraded by one increment as confidence interval crosses one MID or two increments as confidence interval crosses both MIDs Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 108: Clinical evidence summary: Nucifora 2006: Mid-length MDT clinic (MDTc) vs Primary care for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTc (95% CI) VERY LOWa, b due to risk of bias, imprecision rate ratio (from 217 fewer to 289 more) VERY LOWa, b due to risk of bias, imprecision (from 17 fewer to 243 more) Quality of life Minnesota LWHFQ (change score) lower=better. Scale from: 0 to 105. VERY LOWa, b due to risk of bias, imprecision The mean change MLWFQ in the control groups was The mean in the intervention groups was 4 higher (worse) (1.82 lower to 9.82 higher) Prescribed ACE-I 178 MODERATEa due to risk of bias (from 113 fewer to 121 more) Prescribed beta-blocker 178 VERY LOWa, b due to risk of bias, imprecision (from 122 fewer to 81 more) Taking prescribed medication 178 LOWa due to risk of bias (from 67 fewer to 143 more) (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) Downgraded by 1 increment as confidence interval crosses 1 MID or 2 increments as confidence interval crosses both MIDs. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 9.2.3.1.7 High risk, Mid-length, Nurse-led or pharmacist-led clinic Table 109: Clinical evidence summary: Driscoll 2014: Nurse-led clinic (MDTn) vs Primary / secondary care for high risk HFREF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary/secondary Risk difference with MDTn (95% CI) Hospitalisations and Emergency department attendances VERY LOWa, b due to risk of bias, imprecision rate ratio 231 events per 1000 person years 76 fewer events admissions per 1000 person years (from 215 fewer to 1000 more) VERY LOWa, b due to risk of bias, imprecision peto OR c (from 120 fewer to 280 more)d Quality of life MLWHFQ (change score) lower=better. Scale from: 0 to 105. LOWa due to risk of bias The mean change MLWHFQ in the control groups was The mean quality of life in the intervention groups was 2.80 lower (better) (13.68 lower to 8.08 higher) Prescribed "optimal" dose beta-blocker 24 VERY LOWa, b due to risk of bias, imprecision (from 4 more to 1000 more) (a) 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) Downgraded 1 increment as confidence interval crossed 1 MID or 2 increments as confidence interval crossed both MIDs. (c) Cannot be estimated as no events in control arm. (d) Absolute difference calculated by RevMan. Table 110: Clinical evidence summary: Ekman 1998: Mid-length Nurse-led clinic (MDTn) vs Primary care (1 control) 3-6 months for high risk HF Outcomes No of Participants Quality of the evidence Relative effect Anticipated absolute effects Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: (studies) Follow up (GRADE) (95% CI) Risk with primary care Risk difference with MDTn (95% CI) LOWa, b due to risk of bias, imprecision rate ratio 0.92 (from 385 fewer to 265 more) VERY LOWa due to risk of bias, imprecision (from 62 fewer to 250 more) NYHA class change (a proxy for QoL) mean level (I-IV), lower=better. Scale from: 1 to 4. LOWa, c due to risk of bias, indirectness The mean NYHA class change in the control groups was The mean NYHA class change (a proxy for qol) in the intervention groups was 0.10 higher (less improvement) (0.15 lower to 0.35 higher) Prescribed ACE-I 145 LOWa, b due to risk of bias, imprecision (from 69 fewer to 257 more) (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) Downgraded by one increment as confidence interval cross one MID or downgraded by two increments as confidence interval crosses both MID. (c) Downgraded due to indirectness as a proxy measure of quality of life was reported by the study. 9.2.3.1.8 High risk, Mid-length, Case-management Table 111: Clinical Evidence Summary: J-HOMECARE (Tsuchihashi-Makaya 2013): Mid-length Case management (MDTcm) vs Cardiology clinic for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTcm VERY LOWa,b,c estimated risk: (from 4 fewer to 148 fewer) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTcm 12 months due to risk of bias, indirectness, imprecision VERY LOWa, c due to risk of bias, imprecision (from 58 fewer to 159 more) Quality of life (physical) SF-8 physical component, final score. higher=better. Scale from: 0 to 100. VERY LOWa,c due to risk of bias, imprecision The mean SF-8 physical in the control groups was The mean in the intervention groups was 2.00 higher (better) (1.18 lower to 5.18 higher) Quality of life (mental) SF-8 mental health component, final score. higher=better. Scale from: 0 to 100. LOWa due to risk of bias The mean SF-8 mental in the control groups was The mean quality of life (mental) in the intervention groups was 2.00 higher (better) (0.67 lower to 4.67 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) Downgraded for indirectness as not protocol outcome of count rates for hospitalisations. (c) Downgraded one increment as confidence interval crosses one MID or two increments as confidence interval crosses two MID. (d) Used estimated control rate. 9.2.3.1.9 High risk, Long, Home-based MDT Table 112: Clinical Evidence Summary: COACH intensive (Jaarsma 2008): Long Home based MDT (MDThome) vs Cardiology clinic in high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDThome (95% CI) LOWa, b rate ratio 1.10 (from 44 fewer to 299 more) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDThome (95% CI) 18 months due to risk of bias, imprecision LOWa, b due to risk of bias, imprecision (from 105 fewer to 19 more) (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) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both. 9.2.3.2 High risk, Long, MDT clinic Table 113: Clinical Evidence Summary: Auckland-HF (Doughty 2002): Long MDT clinic (MDTc) vs Primary +/- Secondary care in high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference with MDTc (95% CI) LOWa, b due to risk of bias, imprecision rate ratio 0.76 (from 64 fewer to 635 fewer) VERY LOWa, b due to risk of bias, imprecision (from 136 fewer to 77 fewer) Quality of life Minnesota LWHFQ (change score) lower=better. Scale from: 0 to 105. LOWa due to risk of bias The mean change in MLWHFQ in the control groups was The mean change in the intervention groups was 7 lower (greater improvement) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference with MDTc (95% CI) Prescribed ACE-I 154 LOWa,b due to risk of bias, imprecision (from 29 fewer to 254 more) (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) Downgraded by one increment as confidence interval cross 1 MID or 2 increments as confidence interval crosses both MID. Table 114: Clinical Evidence Summary: Capomolla 2002: Long MDT clinic (MDTc) vs Cardiology clinic in high risk HFREF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTc (95% CI) MODERATEa due to risk of bias rate ratio 0.18 (from 428 fewer to 575 fewer) Cardiac Death 234 LOWa, b due to risk of bias, indirectness (from 84 fewer to 164 fewer) Utility (proxy for Quality of life) higher=better. Scale from: 0 to 1. VERY LOWa, c, d due to risk of bias, indirectness, imprecision The mean utility in the control groups was The mean utility in the intervention groups was 0.09 higher (better) ACE-I dose prescribed (long acting only) MODERATEa due to risk of bias The mean ace-i dose prescribed (long acting only) in the control groups was The mean ace-i dose prescribed (long acting only) in the intervention groups was 8 mg higher Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTc (95% CI) Beta-blocker dose prescribed MODERATEa due to risk of bias The mean beta- blocker dose prescribed in the control groups was 13 mg The mean beta-blocker dose prescribed in the intervention groups was 21 mg 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) Downgraded for indirectness as the outcome was not the protocol all-cause mortality. (c) Downgraded as not a protocol outcome for quality of life. Table 115: Clinical Evidence Summary: DEAL-HF (De la Porte 2007): Long MDT clinic (MDTc) vs Cardiology clinic for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTc (95% CI) Hospitalisation Days in hospital MODERATEa due to indirectness Rate Ratio 0.56 5279 per 1000 2310 fewer days in hospital per 1000 (from 1890 fewer to 2680 fewer)b MODERATEc due to imprecision (from 136 fewer to 6 more) (a) Downgraded due to indirectness as not protocol outcome for hospitalisation of count rates. (b) Manually calculated as GRADE cannot process RD above 1000. (c) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 116: Clinical Evidence Summary: Del Sindaco 2007:Long MDT clinic (MDTc) vs Primary / secondary care for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary/s econdary care Risk difference with MDTc (95% CI) Hospitalisations - dichotomous 173 VERY LOWa, b, c due to risk of bias, indirectness, imprecision 187 fewer people admitted per 1000 (from 52 fewer to 299 fewer) VERY LOWa, c due to risk of bias, imprecision (from 138 fewer to 91 more) (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) Downgraded for indirectness as not the protocol outcomes for hospitalisations, count rate. (c) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. Table 117: Clinical Evidence Summary: PRICE (Atienza 2004): Long MDT clinic (MDTc) vs Cardiology for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTc (95% CI) MODERATEa due to imprecision rate ratio (from 183 fewer to 526 fewer) HIGH (from 36 more to 290 more) Quality of life 220 The mean quality of life in The mean quality of life in the Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTc (95% CI) Minnesota LWHFQ, final score. lower=better. Scale from: 0 to 105. LOWa, b due to risk of bias, imprecision the control groups was intervention groups was 6.60 lower (better) Prescribed ACE-I 153 LOWa, b due to risk of bias, imprecision (from 151 fewer to 145 more) Prescribed beta-blocker 153 LOWa, b due to risk of bias, imprecision (from 66 more to 487 more) (a) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. (b) 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. 9.2.3.2.1 High risk. Long, Nurse-led or pharmacist-led clinic Table 118: Clinical Evidence Summary: COACH basic (Jaarsma 2008): Long Nurse-led clinic (MDTn) vs Cardiology clinic in high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTn (95% CI) MODERATEa due to risk of bias rate ratio 11 more per admissions 1000 (from 133 fewer to 189 more) LOWa, b due to risk of bias, (from 88 fewer to 43 more) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with cardiology clinic Risk difference with MDTn (95% CI) imprecision (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) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. Table 119: Clinical Evidence Summary: OPTIMAL (Mejhert 2004): Long Nurse-led clinic (MDTn) vs Primary care for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTn (95% CI) LOWa, b due to risk of bias, imprecision rate ratio (from 1000 fewer to 98 more) LOWa, b due to risk of bias, imprecision (from 55 fewer to 236 more) Quality of life Nottingham Health Profile Part 1, lower=better. Scale from: 0 to 600. LOWa due to risk of bias The mean quality of life in the control groups was The mean quality of life in the intervention groups was (21 lower to 39 higher) Prescribed ACE-I 208 VERY LOWa, b due to risk of bias, imprecision (from 183 fewer to 59 more) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTn (95% CI) LOWa, b due to risk of bias, imprecision (from 180 fewer to 74 more) (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) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both. 9.2.3.2.2 High risk, Long, Case Management Table 120: Clinical Evidence Summary: Berger 2010: Long Case-management (MDTcm) vs Primary +/- secondary care (1/2 control), for >6 months high risk HFREF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary +/- secondary care Risk difference MDTcm (95% CI) Hospitalisations - dichotomous VERY LOWa, b, c due to risk of bias, indirectness, imprecision 75 fewer people admitted per (from 199 fewer to 66 more) LOWa, c due to risk of bias, imprecision (from 43 fewer to 249 fewer) Prescribed ACE-I or ARB 180 MODERATEa due to risk of bias (from 39 fewer to 58 more) Prescribed beta-blocker 186 LOWa, c due to risk of bias, imprecision (from 25 more to 211 more) (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) Downgraded for indirectness as "count rate" was the protocol outcome for hospitalisation, and this is proportion who were hospitalised at least once. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: (c) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. 9.2.3.2.3 Low risk, Short No studies were identified in these categories. 9.2.3.2.4 Low risk, Mid-length No studies were identified in these categories. 9.2.3.2.5 Low risk, Long, Home-based MDT No studies were identified in this category. 9.2.3.2.6 Low risk, Long, MDT clinic Table 121: Clinical Evidence Summary: Northstar (Schou 2013): Extended follow-up in MDT clinic (MDTc) vs Primary care (1 control) >6 months for low risk HF (stable HFREF) Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTc (95% CI) HIGH rate ratio 0.94 (from 226 fewer to 75 more) LOWa due to imprecision (from 34 fewer to 62 more) Quality of life Minnesota LWHFQ (change score) lower=better. Scale MODERATEb, c The mean change in MLWHFQ in the control groups was The mean change in the intervention groups was 1 lower/better than change in the Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTc (95% CI) from: 0 to 105. 2 years due to risk of bias 0 (IQR -1 to 0) control group Prescribed ACE-I 920 MODERATEc due to risk of bias (from 44 fewer to 35 more) Prescribed beta-blocker 920 MODERATEc due to risk of bias (from 44 fewer to 44 more) Adverse - serum creatinine increase >50% during follow-up VERY LOWa, c due to risk of bias, imprecision 35 cases renal failure per 2 fewer renal failure per 1000 (from 20 fewer to 35 more) Adverse - hyperkalaemia (potassium > 5.0mmol/l) at follow-up LOWa, c due to risk of bias, imprecision (from 45 fewer to 6 more) Adverse - hypotension 723 VERY LOWa, c due to risk of bias, imprecision (from 4 fewer to 42 more) (a) Downgraded by one increment as confidence interval crosses one MID or two increments as confidence interval crosses both MID. (b) Precision cannot be formally assessed, but interquartile range suggests small confidence interval. (c) 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. 9.2.3.2.7 Low risk, Long, Nurse-led or pharmacist-led clinic Table 122: Clinical Evidence Summary: Agvall 2013: Long Nurse-led clinic (MDTcm) vs Primary care (1 control), >6 months for low-risk HFREF Outcomes No of Participants Quality of the evidence Relative effect Anticipated absolute effects Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: (studies) Follow up (GRADE) (95% CI) Risk with primary care Risk difference with MDTcm(95% CI) LOWa, b due to risk of bias, imprecision rate ratio 0.72 (from 334 fewer to 69 more) Point estimate suggests clinical benefit from MDTcm VERY LOWa, b due to risk of bias, imprecision (from 48 fewer to 120 more) Prescribed ACE-I or ARB LOWa, b due to risk of bias, imprecision (from 67 more to 260 more) Prescribed beta- blocker LOWa, b due to risk of bias, imprecision (from 163 fewer to 101 more) Renal function Serum creatinine at follow-up. Lower=better MODERATEa, b due to risk of bias The mean serum creatinine in the control groups was The mean renal function in the intervention groups was 1.90 umol/l lower (11.88 lower to 8.08 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) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. Table 123: Clinical Evidence Summary: Varma 1999: Long Pharmacist-led clinic (MDT pharm) vs Primary care (1 control) >6 months for low risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDT pharm (95% CI) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDT pharm (95% CI) VERY LOWa, b due to risk of bias, imprecision ratio (from 20 fewer to 481 fewer) VERY LOWa, b due to risk of bias, imprecision (from 106 fewer to 263 more) Quality of life Minnesota LWHFQ, lower=better. Scale from: 0 to 105. VERY LOWa, b due to risk of bias, imprecision The mean MLWHFQ final score in the control groups was The mean quality of life in the intervention groups was 6.40 lower (better) Taking prescribed medication Self-report LOWa due to risk of bias (from 67 fewer to 172 more) Taking prescribed medication Automated measure VERY LOWa, b due to risk of bias, imprecision (from 15 fewer to 1000 more) (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) Downgraded by one increment as confidence interval crosses one MID or two increments as confidence interval crosses both MID. 9.2.3.3 Low risk, Long, Case-management Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 124: Clinical Evidence Summary: HICMann (Peters-Klimm 2010): Non-specialist case management (MDTcm) vs Primary care (1 control) >6 months for HFREF Outcomes No of Participant s (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTcm VERY LOWa, b due to risk of bias, imprecision rate ratio (from 82 fewer to 351 more) VERY LOWa, b due to risk of bias, imprecision (from 35 fewer to 131 more) Quality of life Kansas City Cardiomyopathy Questionnaire, final score. higher=better. Scale from: 0 to 100. VERY LOWa, b due to risk of bias, imprecision The KCCQ final score in the control groups was The mean KCCQ in the intervention groups was 1.70 higher (better) (3.28 lower to 6.68 higher) Quality of life (physical) SF-36 physical health composite, final score. higher=better. Scale from: 0 to 100. LOWa due to risk of bias The mean SF-physical in the control groups was The mean SF-physical in the intervention groups was 0.3 lower (worse) (3.25 lower to 2.65 higher) Quality of life (mental) SF-36 mental health composite, final score. higher=better. Scale from: 0 to 100. LOWa due to risk of bias The mean SF-mental in the control groups was The mean SF-mental in the intervention groups was 0.1 lower (worse) (3.5 lower to 3.5 higher) Prescribed double therapy of ACE-I/ARB and B- blocker LOWa due to risk of bias (from 115 fewer to 144 more) Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: (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) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. Table 125: Clinical Evidence Summary: Martensson 2005: Non-specialist case management (MDTcm) vs Primary care (1 control) > 6 months for high risk HF Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with primary care Risk difference with MDTcm (95% CI) VERY LOWa, b due to risk of bias, imprecision (from 3 fewer to 418 more) Prescribed ACE-I at target dose 130 VERY LOWa, b due to risk of bias, imprecision 574 ACE-I per 92 fewer ACE-I per 1000 (from 224 fewer to 97 more) Prescribed beta-blocker at target dose 130 VERY LOWa, b due to risk of bias, imprecision 235 B-blocker per 9 fewer B-blocker per 1000 (from 115 fewer to 188 more) (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) Downgraded by one increment as confidence interval crosses one MID or two increments as confidence interval crosses both MID. Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 9.2.4 Economic evidence Published literature Five health economic studies were identified with the relevant comparison and have been included in this review. 22 To maintain consistency with the clinical review these have also been reported according to the clinical categories specified above. One health economic study was identified for the high risk, mid-length intervention, MDT clinic category; 2 health economic studies were identified for the high risk, long intervention, MDT clinic category; 1 health economic study was identified for the high risk, long intervention, nurse led MDT; and 1 health economic study was identified for the high risk, long intervention, case management MDT. No economic evaluations were identified for the remaining categories. These are summarised in the health economic evidence profiles below (Table 126, Table 127, Table 128 and Table 129) and the health economic evidence tables in Appendix G. One economic evaluation was selectively excluded due to the availability of more applicable evidence. This is listed in appendix J, with reasons for exclusion given. See also the health economic study selection flow chart in Appendix D. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 126: Health economic evidence profile: Home-based MDT clinic (mid-length intervention) vs usual care in high risk patients Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty Sahlen [Sweden] Partially applicable (a) Potentially serious limitations (b) Cost-utility analysis (health outcome: QALYs) Within-trial analysis of a RCT Population: adults with chronic heart failure with NYHA class III-IV symptoms and a marker of severity Interventions: 1. Usual care 2. MDT - consisting of a heart failure nurse, palliative care nurse, cardiologist, palliative care physician, physiotherapist and occupational therapist 6 month follow-up saving of QALYs (more effective and less costly) Uncertainty not reported for cost effectiveness Conclusions robust to sensitivity analyses. Abbreviations: QALY: quality-adjusted life years; RCT: randomised controlled trial (a) Single centre study from a county council hospital in V sterbotten County, Sweden and therefore resource use and 2012 costs may not reflect current UK NHS context. (b) Short time horizon may not capture full costs and effects of the intervention. EQ-5D reported differently to the clinical trial evidence. Only minimal sensitivity analyses were carried out to quantify uncertainty. Table 127: Health economic evidence profile: MDT clinic (long intervention) vs usual care in high risk patients Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty Atienza [Spain] Partially applicable (a) Potentially serious limitations Cost-consequence analysis (health outcomes: 1 year mortality rate, all-cause saving of See clinical review of same paper n/a None undertaken. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty (b) readmissions, quality of life as measured by the MLWHFQ) Within-trial analysis of same paper in clinical review Population: people discharged from cardiology wards with a primary diagnosis of heart failure. Interventions: 1. Usual care 2. MDT - consisting of a specialist cardiac nurse, primary care physician and cardiologist. 16 month follow up (mortality, all- cause hospitalisation, quality of life). Pulignano [Italy] Partially applicable (c) Potentially serious limitations (d) Cost-effectiveness analysis (health outcomes: death or readmission for heart failure and all-cause admission rate) Within-trial analysis of a RCT Population: people over the age of 70 with heart failure with reduced and normal ejection fraction, discharged home after a hospitalisation. Interventions: 1. Usual care (primary/ secondary care) 2. Multidisciplinary team saving of See clinical review of Del Int 2 saves death and/or heart failure- related admission avoided. Int 2 saves 2,155 per all- cause admission avoided. None undertaken. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty consisting of a cardiologist, experienced in geriatrics (case managers), two to four specialised nurses, and the patient s primary care physician. 2 year follow up Abbreviations: QALY: quality-adjusted life years; RCT: randomised controlled trial (a) Spanish resource use data and unit costs (year not reported, assumed to be 2004) may not reflect current NHS context. QALYs were not used as the health outcome measure (b) Within-trial analysis and so does not reflect the full body of available evidence available for this intervention. Atienza is 1 of 5 studies included comparing MDT clinic to usual care in high risk patients. No exploration of uncertainty. (c) Italian national health service resource use and unit costs may not reflect current UK NHS context. QALY data was not reported clearly enough to report and therefore were not used as the health outcome measure. Discounting was not applied. (d) Within-trial analysis and therefore does not reflect the full body of evidence available for this comparison. Pulignano is 1 of 5 studies included comparing MDT clinic to usual care in high risk patients. No exploration of uncertainty. Table 128: Health economic evidence profile: Home-based MDT (long intervention) vs nurse led MDT clinic (long intervention) vs usual care in high risk patients Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty [Netherlands] Partially applicable (a) Potentially serious limitations (b) Cost-utility analysis (health outcome: QALYs) Within-trial analysis of a RCT Population: Patients >18 years old with evidence of structural cardiac dysfunction Interventions: 1. Usual care (cardiology clinic) 2-1: cost saving and 3 (more effective and less costly) (c) Probability intervention 2 Conclusions robust to sensitivity analysis. Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty 2. Basic MDT 3. Intensive MDT 18 month follow-up Abbreviations: QALY: quality-adjusted life years; RCT: randomised controlled trial (a) This analysis has been undertaken from a Dutch perspective using 2009 unit costs and therefore may not reflect current NHS context. Does not include important cost aspects such as procedures during hospital admission. EQ-5D was not used. (b) Probabilistic sensitivity analysis was not presented at 20k/QALY. No discounting was undertaken; however the time-horizon was only 18 months and so is unlikely to have a significant effect. Excluded drug costs, cost of procedures conducted during hospitalisation or short term hospital admission as not rigorously reported in associated trial. (c) This study also reports results for sub-groups according to NYHA class. In patients with less severe heart failure (NYHA class I-II) intervention 2 dominates interventions 1 and 3. However, in patients with severe heart failure (NYHA class III-IV) intervention 1 is the most cost effective option. Table 129: Health economic evidence profile: MDT (long intervention - case-management) vs usual care (primary +/- secondary) in high risk patients Study Applicability Limitations Other comments Incremental cost Incremental effects Cost- effectiveness Uncertainty Moertl [Austrian] Partially applicable (a) Potentially serious limitations (b) Cost-utility analysis, Markov model Population: Patients with heart failure discharged after a heart failure hospitalisation Comparators: 1. Usual care in community 2. Nurse-led MDT 20 year time horizon modelled QALYs per QALY gained (c) Uncertainty not reported for cost effectiveness Conclusions robust to sensitivity analyses (including discount rate to 3% and 0%). Abbreviations: ICER: Incremental cost effectiveness ratio; MDT: multidisciplinary team; QALY: quality-adjusted life years. (a) Austrian payer perspective. EQ-5D not used to capture quality of life - utility scores converted from MLWHF questionnaire using previously published algorithm. Costs and effects discounted at 5%. (b) Cost of GP visits and drug costs were not collected and not included in the analysis of the clinical trial phase. (c) An additional comparator was also included in the study that involved intensive NT-proBNP guided patient management in addition to multidisciplinary care. This comparator dominates (more effective, less costly) both usual care and the nurse-led MDT alone. Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 9.2.5 Evidence statements Clinical Overall 22 studies were included in the review. No meta-analysis was conducted due to the heterogeneous nature of the interventions and populations in the included studies. The studies were grouped into strata based on the population risk level (high, low) and the length of the intervention (long, mid, short), and were also categorised into one of four intervention types (home-based MDT, MDT clinic, nurse-led or pharmacist-led clinic, or case management). High risk Short Home-based MDT No studies were identified in this category. MDT clinic This category included two studies with high risk populations exposed to a short MDT clinic intervention. For the outcome of all-cause hospitalisations, the evidence was inconsistent, with one study (n=98) suggesting a clinically important reduction and the other (n=112) suggesting a clinically important increase (moderate to low quality evidence). The evidence from both studies did not demonstrate a clear effect with the confidence interval ranging from a decrease and increase in all- cause mortality.One of the studies (n=112) showed a clinically important increase in prescribing of ACE inhibitors and beta-blockers (high to moderate quality evidence). Nurse-led or pharmacist-led clinic No studies were identified in this category. Case-management No studies were identified in this category. High risk, Mid-length Home-based MDT This category included one study (n=72) with a high risk population exposed to a mid-length home- based MDT intervention. The evidence showed a clinically important reduction in hospitalisations (high quality evidence) and a clinically important improvement in quality of life (very low quality evidence). Mortality did not demonstrate a clear effect with the confidence interval ranging from a decrease and increase in all-cause mortality. MDT clinic This category included three studies with high risk populations exposed to mid-length MDT clinic interventions. The evidence on hospitalisations was low to very low quality and inconsistent, with two studies (n=7117 and n=230) suggesting a clinically important reduction, and the third study (n=200) suggesting no clinical difference. 