An integrative review on facilitators and barriers in delivering and managing injectable therapies in chronic conditions: A part of the ACNAP project 'injectable medicines among patients with cardiovascular conditions'.

INTRODUCTION: Although preventive health and therapeutics have benefited from advances in drug development and device innovation, translating these evidence-based treatments into real-world practice remains challenging. AIM: The current integrative review aims to identify facilitators and barriers and perceptions in delivering and managing injectable therapies from patient perspectives. METHODS: An integrative review was conducted in the databases of PubMed, CINAHL, PsycINFO and Cochrane. Keywords were used "Injectable therapy", "IV therapy", "SC therapy", "long term injectable therapies", "self-administered injectable therapy", "patients", "caregivers", "family", "carers", "facilitators", "barriers", "perspectives", "needs", "expectations", "chronic disease", "cardiovascular disease" linked with the words "OR" and "AND". The search was limited from January 2000 to July 2019. Inclusion and exclusion criteria were used. RESULTS: Twenty studies were identified from the literature search. Studies followed qualitative, quantitative methodology and mixed methods. Facilitators included: health improvement, prevention of disease complications, taking control of their disease, effectiveness of the medication and convenience in management. Barriers included: fear of needles, insulin will cause harm, poor perception of the benefits of injectable therapies on their quality of life, inconvenience in self-management, social stigma, impact on daily living, financial barriers, lack of education. Perceptions included: 'treatment of last resort', 'life becomes less flexible', 'injectables were punishment/restriction', 'personal failure of self-management'. CONCLUSION: Evidence shows how to create effective communication and shared decision-making relationships to provide best possible care to patients who need injectable therapy and support for self-management. Future research might help guide response to the fears and barriers of the patients using patients' perspectives.

Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI).

INTRODUCTION: Percutaneous coronary intervention (PCI) aims to provide instant relief of symptoms, and improve functional capacity and prognosis in patients with coronary artery disease. Although patients may experience a quick recovery, continuity of care from hospital to home can be challenging. Within a short time span, patients must adjust their lifestyle, incorporate medications and acquire new support. Thus, CONCARDPCI will identify bottlenecks in the patient journey from a patient perspective to lay the groundwork for integrated, coherent pathways with innovative modes of healthcare delivery. The main objective of the CONCARDPCI is to investigate (1) continuity of care, (2) health literacy and self-management, (3) adherence to treatment, and (4) healthcare utilisation and costs, and to determine associations with future short and long-term health outcomes in patients after PCI. METHODS AND ANALYSIS: This prospective multicentre cohort study organised in four thematic projects plans to include 3000 patients. All patients undergoing PCI at seven large PCI centres based in two Nordic countries are prospectively screened for eligibility and included in a cohort with a 1-year follow-up period including data collection of patient-reported outcomes (PRO) and a further 10-year follow-up for adverse events. In addition to PROs, data are collected from patient medical records and national compulsory registries. ETHICS AND DISSEMINATION: Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations. TRIAL REGISTRATION NUMBER: NCT03810612.

The global epidemics of diabetes in the 21st century: Current situation and perspectives.

Diabetes is on the rise worldwide, with a global prevalence in adults in 2017 being 8.8% of the world population, with the anticipation of a further increase to 9.9% by 2045. In total numbers, this reflects a population of 424.9 million people with diabetes worldwide in 2017, with an estimate of a 48% increase to 628.6 million people by 2045. Depending on age, global diabetes prevalence is about 5%, 10%, 15% and close to 20%, respectively, for the age groups 35-39, 45-49, 55-59 and 65-69 years. On a global scale, diabetes hits particularly 'middle aged' people between 40 and 59 years, which causes serious economic and social implications. Furthermore, diabetes affects especially low and middle income countries, as 77% of all people with diabetes worldwide live in those countries. In addition to overt diabetes, an estimated 352.1 million people worldwide are at risk of diabetes, i.e. have defined pre-diabetes, a figure which is anticipated to rise to 531.6 million by 2045. Some 70-75% of all patients with established coronary artery disease, e.g. with acute myocardial infarction, show concomitant diabetes or abnormal glucose regulation, i.e. close to 50% have overt diabetes, with as many as 20% of those being undiagnosed and another 25% having pre-diabetes.

Do Non-participants at Screening have a Different Threshold for an Acceptable Benefit-Harm Ratio than Participants? Results of a Discrete Choice Experiment.

OBJECTIVE: The objective of the study was to investigate non-participants' preferences for cardiovascular disease screening programme characteristics and whether non-participation can be rationally explained by differences in preferences, decision-making styles and informational needs between non-participants and participants. METHODS: We conducted a discrete choice experiment at three screening sites between June and December 2017 among 371 male non-participants and 830 male participants who were asked to trade different levels of five key programme characteristics (chance of health benefit, risk of overtreatment, risk of later regret, screening duration and screening location). Data were analysed using a multinomial mixed-logit model. Health benefit was used as a payment vehicle for estimation of marginal substitution rates. RESULTS: Non-participants were willing to accept that 0.127 (95% confidence interval 0.103-0.154) fewer lives would be saved to avoid overtreatment of one individual, whilst participants were willing to accept 0.085 (95% confidence interval 0.077-0.094) fewer lives saved. This translates into non-participants valuing health benefits 7.9 times higher than overtreatment. The corresponding value of participants is 11.8. Similarly, non-participants had higher requirements than participants for advanced technology and a quicker screening duration. With regard to their participation decision, 64% of the non-participants felt certain about their choice compared with 89% among participants. CONCLUSIONS: This study shows that non-participants have different preferences than participants at screening as they express relatively more concern about overtreatment and have higher requirements for a high-tech screening programme. Non-participants also report to be more uncertain about their participation decision and more often seek additional information to the standard information provided in the invitation letter. Further studies on informational needs and effective communication strategies are warranted to ensure that non-participation is a fully informed choice.

Individual preferences on the balancing of good and harm of cardiovascular disease screening.

OBJECTIVE: Transition towards value-based healthcare requires insight into what makes value to the individual. The aim was to elicit individual preferences for cardiovascular disease screening with respect to the difficult balancing of good and harm as well as mode of delivery. METHODS: A discrete choice experiment was conducted as a cross-sectional survey among 1231 male screening participants at three Danish hospitals between June and December 2017. Participants chose between hypothetical screening programmes characterised by varying levels of mortality risk reduction, avoidance of overtreatment, avoidance of regretting participation, screening duration and location. A multinomial mixed logit model was used to model the preferences and the willingness to trade mortality risk reduction for improvements on other characteristics. RESULTS: Respondents expressed preferences for improvements on all programme characteristics. They were willing to give up 0.09 (95% CI 0.08 to 0.09) lives saved per 1000 screened to avoid one individual being over treated. Similarly, respondents were willing to give up 1.22 (95% CI 0.90 to 1.55) or 5.21 (95% CI 4.78 to 5.67) lives saved per 1000 screened to upgrade the location from general practice to a hospital or to a high-tech hospital, respectively. Subgroup analysis revealed important preference heterogeneity with respect to smoking status, level of health literacy and self-perceived risk of cardiovascular disease. CONCLUSIONS: Individuals are able to express clear preferences about what makes value to them. Not only health benefit but also time with health professionals and access to specialised facilities were important. This information could guide the optimal programme design in search of value-based healthcare.

Challenges in secondary prevention after acute myocardial infarction: A call for action.

Worldwide, each year more than 7 million people experience myocardial infarction, in which one-year mortality rates are now in the range of 10%, but vary with patient characteristics. The consequences are even more dramatic: among patients who survive, 20% suffer a second cardiovascular event in the first year and approximately 50% of major coronary events occur in those with a previous hospital discharge diagnosis of ischaemic heart disease. The people behind these numbers spur this call for action. Prevention after myocardial infarction is crucial to reduce risk and suffering. Evidence-based interventions include optimal medical treatment with anti-platelets and statins, achievement of blood pressure, lipid and blood glucose targets, and appropriate lifestyle changes. The European Society of Cardiology and its constituent bodies are determined to embrace this challenge by developing a consensus document in which the existing gaps for secondary prevention strategies are reviewed. Effective interventions in relation to the patients, healthcare providers and healthcare systems are proposed and discussed. Finally, innovative strategies in hospital as well as in outpatient and long-term settings are endorsed.

Challenges in secondary prevention after acute myocardial infarction: A call for action.

Worldwide, each year more than 7 million people experience myocardial infarction, in which one-year mortality rates are now in the range of 10%, but vary with patient characteristics. The consequences are even more dramatic: among patients who survive, 20% suffer a second cardiovascular event in the first year and approximately 50% of major coronary events occur in those with a previous hospital discharge diagnosis of ischaemic heart disease. The people behind these numbers spur this call for action. Prevention after myocardial infarction is crucial to reduce risk and suffering. Evidence-based interventions include optimal medical treatment with anti-platelets and statins, achieve-ment of blood pressure, lipid and blood glucose targets, and appropriate lifestyle changes. The European Society of Cardiology and its constituent bodies are determined to embrace this challenge by developing a consensus document in which the existing gaps for secondary prevention strategies are reviewed. Effective interventions in relation to the patients, healthcare providers and healthcare systems are proposed and discussed. Finally, innovative strategies in hospital as well as in outpatient and long-term settings are endorsed.

Cost-utility analysis of cardiac rehabilitation after conventional heart valve surgery versus usual care.

Background While cardiac rehabilitation in patients with ischaemic heart disease and heart failure is considered cost-effective, this evidence may not be transferable to heart valve surgery patients. The aim of this study was to investigate the cost-effectiveness of cardiac rehabilitation following heart valve surgery. Design We conducted a cost-utility analysis based on a randomised controlled trial of 147 patients who had undergone heart valve surgery and were followed for 6 months. Methods Patients were randomised to cardiac rehabilitation consisting of 12 weeks of physical exercise training and monthly psycho-educational consultations or to usual care. Costs were measured from a societal perspective and quality-adjusted life years were based on the EuroQol five-dimensional questionnaire (EQ-5D). Estimates were presented as means and 95% confidence intervals (CIs) based on bootstrapping. Costs and effect differences were presented in a cost-effectiveness plane and were transformed into net benefit and presented in cost-effectiveness acceptability curves. Results No statistically significant differences were found in total societal costs (-1609 Euros; 95% CI: -6162 to 2942 Euros) or in quality-adjusted life years (-0.000; 95% CI -0.021 to 0.020) between groups. However, approximately 70% of the cost and effect differences were located below the x-axis in the cost-effectiveness plane, and the cost-effectiveness acceptability curves showed that the probability for cost- effectiveness of cardiac rehabilitation compared to usual care is at minimum 75%, driven by a tendency towards costs savings. Conclusions Cardiac rehabilitation after heart valve surgery may not have improved health-related quality of life in this study, but is likely to be cost-effective for society, outweighing the extra costs of cardiac rehabilitation.

Challenges in secondary prevention after acute myocardial infarction: A call for action.

Worldwide, each year more than 7 million people experience myocardial infarction, in which one-year mortality rates are now in the range of 10%, but vary with patient characteristics. The consequences are even more dramatic: among patients who survive, 20% suffer a second cardiovascular event in the first year and approximately 50% of major coronary events occur in those with a previous hospital discharge diagnosis of ischaemic heart disease. The people behind these numbers spur this call for action. Prevention after myocardial infarction is crucial to reduce risk and suffering. Evidence-based interventions include optimal medical treatment with anti-platelets and statins, achievement of blood pressure, lipid and blood glucose targets, and appropriate lifestyle changes. The European Society of Cardiology and its constituent bodies are determined to embrace this challenge by developing a consensus document in which the existing gaps for secondary prevention strategies are reviewed. Effective interventions in relation to the patients, healthcare providers and healthcare systems are proposed and discussed. Finally, innovative strategies in hospital as well as in outpatient and long-term settings are endorsed.

Cardiac rehabilitation patients' perspectives on the recovery following heart valve surgery: a narrative analysis.

AIMS: To explore the structure and content of narratives about the recovery process among patients undergoing heart valve surgery participating in cardiac rehabilitation. BACKGROUND: Several studies with short-term follow-up have shown that recovering from cardiac surgery can be challenging, but evidence on the long-term recovery process is very limited, especially following heart valve surgery. Furthermore, few studies have explored the recovery process among cardiac rehabilitation participants. DESIGN: A qualitative study with serial interviews analysed using narrative methods. METHODS: We collected data over 18 months (April 2013-October 2014). We recruited nine patients undergoing heart valve surgery from a randomized trial, CopenHeartVR and conducted 27 individual narrative interviews at 2-3 weeks, 3-4 months and 8-9 months after surgery. FINDINGS: Following heart valve surgery, the participants expected to return to normality. The analysis identified four courses of recovery, with three non-linear complex pathways deviating from the classic restitution narrative: the frustrated struggle to resume normality, the challenged expectation of normality - being in a limbo and becoming a heart patient. These deviating pathways were characterized by physical, existential and mental challenges even up to 9 months after surgery. CONCLUSION: The recovery processes of participants' in cardiac rehabilitation were often more complicated than anticipated. Patients undergoing heart valve surgery may benefit from more extensive medical follow-up immediately after discharge, individual psychological assessment and individualized, realistic information about the recovery trajectory.

Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising because of an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. The secondary outcome is self-assessed mental health measured by the standardized questionnaire Short Form-36. Long-term healthcare utilization and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether cardiac rehabilitation should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 ).

Self-reported health-related quality of life predicts 5-year mortality and hospital readmissions in patients with ischaemic heart disease.

BACKGROUND: Patient health-related quality of life (HRQL) is an important health outcome with lower HRQL associated with adverse events in patients with ischaemic heart disease (IHD). DESIGN: Baseline health-related quality of life was investigated as a predictor of 5-year all-cause mortality and cardiac readmissions in Danish patients with IHD. METHODS: The international HeartQoL Project survey was designed to develop a core HRQL questionnaire for patients with IHD. Baseline scores on each of the 14 items ultimately included in the HeartQoL questionnaire were linked to Danish national health registries and hazard ratios for mortality and readmissions were estimated using Cox regression models. RESULTS: Among 938 eligible Danish patients with IHD, 662 (70.6%) participated in the international HeartQoL Project. During the 5-year follow-up, 83 patients died and 196 patients were readmitted. Adjusted analyses showed a significant linear association between all-cause mortality and both lower global HRQL (HR = 1.67, 95% CI: 1.26-2.23; p<0.001) and physical scores (HR=1.71, 1.33-2.21; p<0.001) and between readmission and both lower global (HR=1.73, 1.41-2.12; p < 0.001) and physical scores (HR = 1.63, 1.35-1.96; p < 0.001). A significant, but non-linear, effect was found for emotional HRQL score on outcomes. CONCLUSION: This study shows a significant and linear relationship between lower global and physical HRQL scores in patients with IHD and 5-year all-cause mortality and cardiac readmission.

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. METHODS: A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. DISCUSSION: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: ClinicalTrials.gov (http://NCT01558765).