Original Title: Efectividad, seguridad y coste-efectividad de la rehabilitación cardíaca extrahospitalaria en cardiopatía isquémica o insuficiencia cardíaca

Authors' objectives: • Evaluate the effectiveness and safety of out-of-hospital CR. • Assess the cost-effectiveness of out-of-hospital CR based on internationally published evidence. • Estimate the cost implications of incorporating out-of-hospital CR into the common portfolio of services in the Spanish National Health System. • Identify ethical, legal, organizational, social, and environmental considerations related to out-of-hospital CR. • Identify research needs and standard outcome measures from the perspectives of patients, family/caregivers, healthcare professionals, and researchers regarding out-of-hospital CR. • Provide recommendations for inclusion in the Spanish National Health System service portfolio based on the conclusions reached.

Authors' results and conclusions: RESULTS: EFFECTIVENESS/SAFETY: Twenty-seven RCTs were included, involving a total of 3005 participants. The overall quality of evidence was rated as very low, mainly due to moderate to high risk of bias in the majority of included studies and imprecision in their results. No significant differences were observed between out-of-hospital CR and hospital-based CR for any critical outcome: mortality (13 studies, RR = 1.19, 95% CI: 0.52, 2.68, very low-quality evidence), myocardial infarction (4 studies, RR = 1.21, 95% CI: 0.48, 3.07, very low-quality evidence), revascularization (5 studies, RR = 0.67, 95% CI: 0.17, 2.63, very low-quality evidence), functional capacity (19 studies, SMD = 0.1, 95% CI: -0.25, 0.04, low-quality evidence), health-related quality of life (HRQOL) (10 studies, SMD = -0.23, 0.23, low-quality evidence), physical component of HRQOL (7 studies, SMD = 0.12, 95% CI: -0.4, 0.16, low-quality evidence), and mental component of HRQOL (8 studies, SMD = 0.07, 95% CI: -0.31, 0.18, very low-quality evidence). No significant differences were found in other important but non-critical variables for decision-making: body mass index, glycemic control, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, systolic blood pressure, diastolic blood pressure, smoking, self-reported physical activity, nutritional habits, anxiety, depression, hospitalizations, visits to Primary Care, and medication consumption. Adherence to programs showed heterogeneous results. Regarding the safety of out-of-hospital CR programs, no reports of serious adverse events were noted, and there were no differences in minor adverse events between out-of-hospital CR and hospital-based CR. COST-EFFECTIVENESS: After eliminating duplicates, 673 references were identified. Nine studies, along with one identified after the review of previous systematic reviews, were included. These 10 studies consisted of economic evaluations conducted parallel to randomized controlled trials. No differences in quality-adjusted life years or effects on clinical measures were observed between groups receiving out-of-hospital CR and those receiving hospital-based CR. Regarding costs, two studies found that out-of-hospital CR could save costs significantly. The remaining studies either found no differences in costs between types of rehabilitation or could not demonstrate the statistical significance of the difference. The two studies of better methodological quality concluded that out-of-hospital CR could be equally effective and less costly than hospital-based CR. COST ANALYSIS: From the hospital perspective, the cost estimation for an out-of-hospital CR program in Primary Care was €375.84 per patient and €6013.44 per health center. If the maximum number of potential patients per health center (300 individuals per year) could receive this type of CR, the costs would amount to €314.77 and €94,429.80, respectively. For home-based CR, the estimated cost was €70.53 per patient and €1128.44 per health center, which would increase to €70.49 and €21,141.92, respectively, if the maximum number of potential patients per health center were attended to. ETHICAL, LEGAL, ORGANIZATIONAL, SOCIAL, AND ENVIRONMENTAL ASPECTS: Nineteen qualitative studies were included, assessing perceptions, experiences, and organizational aspects of out-of-hospital CR. Key topics included patient perspectives/experiences regarding participation in out-of-hospital CR programs, overall acceptability and adherence to programs and their different components, feasibility, barriers and facilitators to implementation from the organizational service perspective, motivational aspects, and perceived benefits by patients, perceptions of tele-rehabilitation or information and communication technologies, adaptation of CR programs, informed decision-making, and impact on equity. Implementation of CR services in non-hospital settings expands access to CR. However, for equitable access to reach the entire population, specific actions such as program adaptations may be required. Women, older individuals, those with comorbidities or frailty, migrants, or vulnerable groups may face greater difficulties in accessing and adhering to HBCR. No studies were identified that could assess the legal or environmental aspects of out-of-hospital CR. Regarding environmental impact (calculation of carbon footprint, waste generation), an indirect assessment was included on the potential reduction of greenhouse gas emissions from proposed out-of-hospital CR programs conducted without the need for travel. However, it would be necessary to evaluate the carbon costs associated with the manufacturing, use, and disposal of equipment and the energy use of telemedicine. CONCLUSIONS: • The available evidence on the effectiveness and safety of out-of-hospital CR compared to hospital-based CR is of very low quality, primarily due to a moderate-to-high risk of bias in the majority of included studies and imprecision in their results. • Regarding effectiveness, no significant differences were observed between out-of-hospital CR and hospital-based CR in any of the evaluated outcome variables: mortality, cardiac events (myocardial infarction, revascularization), functional capacity, modifiable cardiovascular risk factors (BMI, HbA1c, cholesterol, blood pressure, smoking, self-reported physical activity, nutritional habits), HRQOL (both general, mental, and physical), affective symptoms (anxiety and depression), and healthcare services utilization (hospital admissions, visits to Primary Care, medication consumption). Results regarding program adherence were heterogeneous. • Regarding the safety of out-of-hospital CR, no reports of serious adverse events were noted, and there were no differences in minor adverse events between out-of-hospital CR and hospital-based CR. • Ten economic evaluations conducted parallel to RCTs were identified, none of which were conducted in Spain. No differences were observed in quality-adjusted life years or effects on clinical measures between groups receiving out-of-hospital CR and those receiving hospital-based CR. Regarding costs, two studies found that out-of-hospital CR could save costs significantly. The remaining studies either found no differences in costs between types of rehabilitation or could not demonstrate the statistical significance of the difference. The two studies of better methodological quality concluded that out-of-hospital CR could be equally effective and less costly than hospital-based CR. • Considering that Primary Care centers have the necessary infrastructure and material resources for the implementation of these programs, the annual cost for a CR program in Primary Care, based on follow-up consultations and outpatient programs of exercise, health education, and psychological support, serving 16 people stratified as low risk with ischemic heart disease or heart failure in each health center, would be €375.84 per patient and €6013.44 per health center. If this number of individuals reached the maximum estimated for each health center (300 people attended per year), costs would increase by €314.77 and €94,429.80, respectively. • The annual cost for a home-based CR progarm, based on follow-up consultations at the health center and an online CR program, serving 16 people per health center stratified as low risk with ischemic heart disease or heart failure, would be €70.53 per patient and €1128.44 per health center. If this number of individuals reached the maximum estimated for each health center (300 people attended per year), costs would increase by €70.49 and €21,141.92, respectively. • Out-of-hospital CR is acceptable for patients and implementable in the Spanish National Health System. • The implementation of out-of-hospital CR would increase equity of access to cardiac rehabilitation in the Spanish National Health System, while some groups may require additional support or planning to access the service equitably.

Authors' recommendations: A conditional recommendation is made in favor of out-of-hospital CR for patients with ischemic heart disease or heart failure. This conditional recommendation suggests the need to carefully consider the context, resource availability, risk stratification, and the individual circumstances, values, and preferences of the patients.

Authors' methods: EFFECTIVENESS/SAFETY: A systematic review (SR) of high-quality SRs and randomized controlled trials (RCTs) not included in previous SRs was conducted. The Epistemonikos database was consulted for the SR search, and for the specific search of RCTs not included in previous SRs, MEDLINE, Embase, CINAHL, and CENTRAL were consulted. Studies involving individuals with ischemic heart disease (angina pectoris, acute myocardial infarction, and chronic ischemic heart disease) or heart failure were included. Studies evaluating Phase II CR programs developed in non-hospital settings (Primary Care, home-based, and community settings) were included, and they were compared with hospital-based CR. Outcome measures included mortality, cardiac events, health-related quality of life (HRQOL), pulmonary or aerobic capacity, modifiable cardiovascular risk factors, affective symptoms, healthcare services utilization, return to work, program adherence, and adverse events. Meta-analysis was conducted for each outcome measure when the available data allowed it. The assessment of the quality of evidence and the grading of the strength of recommendation were performed following the methodology of the international working group Grading Recommendations Assessment, Development, and Evaluation (GRADE). COST-EFFECTIVENESS: A SR of comprehensive economic evaluations of out-of-hospital CR compared to hospital-based CR was conducted, using criteria similar to those for the effectiveness SR, except for study design and outcome measures. Systematic searches were conducted in June 2023 in electronic databases, including MEDLINE, Embase, CINAHL, WOS, various Ibero-American publication databases, as well as INAHTA, CEA Registry, and PEDro. The methodological quality assessment of the included studies was independently conducted by two reviewers following Drummond et al.'s criteria. The selection, data extraction, and quality assessment of studies were carried out by one reviewer and verified by a second reviewer. A narrative synthesis of the findings was performed. COST ANALYSIS: To conduct the economic evaluation, a cost study was performed from the perspective of the Spanish National Health System for a out-of-hospital CR (Primary Care or home-based), with a duration of 12 months. For CR in Primary Care, the use of resources and costs of follow-up consultations, as well as the sessions for physical exercise, health education, and psychological support programs, all conducted in-person, were taken into account. For home-based CR, the same follow-up consultations in Primary Care were considered, but in this case, the in-person sessions of the different programs were replaced by the content of an online cardiac rehabilitation program. The population considered consisted of 16 patients annually per health center, along with a hypothetical scenario where a maximum of potential patients, around 300 individuals, were attended to per health center. ETHICAL, LEGAL, ORGANIZATIONAL, SOCIAL, AND ENVIRONMENTAL ASPECTS: The analysis of these domains was conducted by applying the algorithm for the assessment of specific ethical, legal, organizational, social, and environmental aspects related to the technology. The algorithm is based on a scoping definition considering whether there are relevant uncertainties for decision-making on these aspects and allows for exploring and conceptualizing the context of the intervention. Relevant uncertainty is understood when specific research questions for the evaluated technology are clearly identified that should be answered to properly assess these aspects. Following the algorithm, it was decided to conduct a qualitative SR to address questions about equity, perception, and barriers to the implementation of out-of-hospital CR, as well as those related to energy consumption, use of toxic substances, waste generation, and the carbon footprint associated with the evaluated technology.

Project Status: Completed

Year Published: 2024

URL for published report: https://sescs.es/informe-rehabilitacion-cardiaca-extrahospitalaria/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es