Coronary calcium scoring as first-line test to detect and exclude coronary artery disease in patients presenting to the general practitioner with stable chest pain: protocol of the cluster-randomised CONCRETE trial.

INTRODUCTION: Identifying and excluding coronary artery disease (CAD) in patients with atypical angina pectoris (AP) and non-specific thoracic complaints is a challenge for general practitioners (GPs). A diagnostic and prognostic tool could help GPs in determining the likelihood of CAD and guide patient management. Studies in outpatient settings have shown that the CT-based coronary calcium score (CCS) has high accuracy for diagnosis and exclusion of CAD. However, the CT CCS test has not been tested in a primary care setting. In the COroNary Calcium scoring as fiRst-linE Test to dEtect and exclude coronary artery disease in GPs patients with stable chest pain (CONCRETE) study, the impact of direct access of GPs to CT CCS will be investigated. We hypothesise that this will allow for early diagnosis of CAD and treatment, more efficient referral to the cardiologist and a reduction of healthcare-related costs. METHODS AND ANALYSIS: CONCRETE is a pragmatic multicentre trial with a cluster randomised design, in which direct GP access to the CT CCS test is compared with standard of care. In both arms, at least 40 GP offices, and circa 800 patients with atypical AP and non-specific thoracic complaints will be included. To determine the increase in detection and treatment rate of CAD in GP offices, the CVRM registration rate is derived from the GPs electronic registration system. Individual patients' data regarding cardiovascular risk factors, expressed chest pain complaints, quality of life, downstream testing and CAD diagnosis will be collected through questionnaires and the electronic GP dossier. ETHICS AND DISSEMINATION: CONCRETE has been approved by the Medical Ethical Committee of the University Medical Center of Groningen. TRIAL REGISTRATION NUMBER: NTR 7475; Pre-results.

The Diagnostic and Prognostic Value of Coronary Calcium Scoring in Stable Chest Pain Patients: A Narrative Review.

BACKGROUND: Non-contrast computed tomography (CT) scanning allows for reliable coronary calcium score (CCS) calculation at a low radiation dose and has been well established as marker to assess the future risk of coronary artery disease (CAD) events in asymptomatic individuals. However, the diagnostic and prognostic value in symptomatic patients remains a matter of debate. This narrative review focuses on the available evidence for CCS in patients with stable chest pain complaints. METHOD: PubMed, Embase, and Web of Science were searched for literature using search terms related to three overarching categories: CT, symptomatic chest pain patients, and coronary calcium. The search resulted in 42 articles fulfilling the inclusion and exclusion criteria: 27 articles (n = 38 137 patients) focused on diagnostic value and 23 articles (n = 44 683 patients) on prognostic value of CCS. Of these, 10 articles (n = 21 208 patients) focused on both the diagnostic and prognostic value of CCS. RESULTS: Between 22 and 10 037 patients were included in the studies on the diagnostic and prognostic value of CCS, including 43 % and 51 % patients with CCS 0. The most evidence is available for patients with a low and intermediate pre-test probability (PTP) of CAD. Overall, the prevalence of obstructive CAD (OCAD, defined as a luminal stenosis of ≥ 50 % in any of the coronary arteries) as determined with CT coronary angiography in CCS 0 patients, was 4.4 % (n = 703/16 074) with a range of 0-26 % in individual studies. The event rate for major adverse cardiac events (MACE) ranged from 0 % to 2.1 % during a follow-up of 1.6 to 6.8 years, resulting in a high negative predictive value for MACE between 98 % and 100 % in CCS 0 patients. At increasing CCS, the OCAD probability and MACE risk increased. OCAD was present in 58.3 % (n = 617/1058) of CCS > 400 patients with percentages ranging from 20 % to 94 % and MACE occurred in 16.7 % (n = 175/1048) of these patients with percentages ranging from 6.9 % to 50 %. CONCLUSION: Accumulating evidence shows that OCAD is unlikely and the MACE risk is very low in symptomatic patients with CCS 0, especially in those with low and intermediate PTPs. This suggests a role of CCS as a gatekeeper for additional diagnostic testing. Increasing CCS is related to an increasing probability of OCAD and risk of cardiac events. Additional research is needed to assess the value of CCS in women and patient management in a primary healthcare setting. KEY POINTS: · A CCS of zero makes OCAD in patients at low-intermediate PTP unlikely. · A CCS of zero is related to a very low risk of MACE. · Categories of increasing CCS are related to increasing rates of OCAD and MACE. · Future studies should focus on the diagnostic and prognostic value of CCS in symptomatic women and the role in primary care. CITATION FORMAT: · Koopman MY, Willemsen RT, van der Harst P et al. The Diagnostic and Prognostic Value of Coronary Calcium Scoring in Stable Chest Pain Patients: A Narrative Review. Fortschr Röntgenstr 2022; 194: 257 - 265.

Screening for cardiovascular disease risk using traditional risk factor assessment or coronary artery calcium scoring: the ROBINSCA trial.

AIMS: Screening for a high cardiovascular disease (CVD) risk followed by preventive treatment can potentially reduce coronary heart disease-related morbidity and mortality. ROBINSCA (Risk Or Benefit IN Screening for CArdiovascular disease) is a population-based randomized controlled screening trial that investigates the effectiveness of CVD screening in asymptomatic participants using the Systematic COronary Risk Evaluation (SCORE) model or coronary artery calcium (CAC) scoring. This study describes the distributions in risk and treatment in the ROBINSCA trial. METHODS AND RESULTS: Individuals at expected elevated CVD risk were randomized into screening arm A (n = 14 478; SCORE, 10-year fatal and non-fatal risk); or screening arm B (n = 14 450; CAC scoring). Preventive treatment was largely advised according to current Dutch guidelines. Risk and treatment differences between the screening arms were analysed. A total of 12 185 participants (84.2%) in arm A and 12 950 (89.6%) in arm B were screened. In total, 48.7% were women, and median age was 62 (interquartile range 10) years. SCORE screening identified 45.1% at low risk (SCORE < 10%), 26.5% at intermediate risk (SCORE 10-20%), and 28.4% at high risk (SCORE ≥ 20%). According to CAC screening, 76.0% were at low risk (Agatston < 100), 15.1% at high risk (Agatston 100-399), and 8.9% at very high risk (Agatston ≥ 400). CAC scoring significantly reduced the number of individuals indicated for preventive treatment compared to SCORE (relative reduction women: 37.2%; men: 28.8%). CONCLUSION: We showed that compared to risk stratification based on SCORE, CAC scoring classified significantly fewer men and women at increased risk, and less preventive treatment was indicated. TRIAL REGISTRATION NUMBER: NTR6471.

Translating the SLIM diabetes prevention intervention into SLIMMER: implications for the Dutch primary health care.

All over the world, prevalence and incidence rates of type 2 diabetes mellitus are rising rapidly. Several trials have demonstrated that prevention by lifestyle intervention is (cost-) effective. This calls for translation of these trials to primary health care. This article gives an overview of the translation of the SLIM diabetes prevention intervention to a Dutch real-life setting and discusses the role of primary health care in implementing lifestyle intervention programmes. Currently, a 1-year pilot study, consisting of a dietary and physical activity part, performed by three GPs, three practice nurses, three dieticians and four physiotherapists is being conducted. The process of translating the SLIM lifestyle intervention to regular primary health care is measured by means of the process indicators: reach, acceptability, implementation integrity, applicability and key factors for success and failure of the intervention. Data will be derived from programme records, observations, focus groups and interviews. Based on these results, our programme will be adjusted to fit the role conception of the professionals and the organization structure in which they work.

Clinical inertia in general practice: widespread and related to the outcome of diabetes care.

BACKGROUND AND AIMS: Clinical inertia is considered a major barrier to better care. We assessed its prevalence, predictors and associations with the intermediate outcomes of diabetes care. MATERIALS AND METHODS: Baseline and follow-up data of a Dutch randomized controlled trial on the implementation of a locally adapted guideline were used. The study involved 30 general practices and 1283 patients. Treatment targets differed between study groups [HbA1c

Refill adherence and polypharmacy among patients with type 2 diabetes in general practice.

BACKGROUND AND AIMS: Non-adherence is considered a major barrier to better outcomes of diabetes care. A relationship has been established between polypharmacy and patients' adherence. This study aims to investigate the occurrence of polypharmacy and non-adherence in general practice, their mutual relationship and the association between adherence and the intermediate outcomes of diabetes care. MATERIALS AND METHODS: We used the baseline and follow-up data of a randomised controlled trial (RCT) that compared usual care with care in accordance with a locally adapted national guideline. This study took place in the Netherlands and involved 30 general practices and 1283 patients. We obtained a complete medication profile of all participants and calculated the number of prescribed drugs and the adherence indices (AI) for oral blood glucose, blood pressure and cholesterol lowering drugs. Patients with an adherence index < 0.8 were considered non-adherent. Clustering at practice level and case-mix were taken into account. RESULTS: Approximately 80% of the participating patients demonstrated an adherence index >or= 0.8 for oral blood glucose, blood pressure and cholesterol lowering drugs. In the intervention group, increase of drug prescriptions exceeded that of controls (1.1 +/- 2.0 vs. 0.6 +/- 1.5, p < 0.001, adjusted p < 0.05). There was evidence of an inverse relationship between the number of drugs that had been prescribed during the last 6 months of the study and patients' adherence to blood pressure lowering medications (adjusted OR 0.84, 95%CI 0.78-0.91). After one year, HbA1c and total cholesterol levels were significantly lower in adherent patients. CONCLUSION: During the intervention the mean number of drug prescriptions increased in both the study groups. This did not result in a lower adherence to blood glucose and cholesterol lowering medications. Given the relationship between the number of medications and patients' adherence to blood pressure lowering drugs, it may be wise to discuss adherence before prescribing multiple drug regimens.

Implementation of locally adapted guidelines on type 2 diabetes.

OBJECTIVE: To assess the effects of a facilitator enhanced multifaceted intervention to implement a locally adapted guideline on the shared care for people with type 2 diabetes. METHODS: During 1 year a cluster-randomized trial was performed in 30 general practices. In the intervention group, nurse facilitators enhanced guideline implementation by analysing barriers to change, introducing structured care, training practice staff and giving performance feedback. Targets for HbA1c%, systolic blood pressure as well as indications for angiotensin converting enzyme/angiotensin receptor blocking agent prescription differed from the national guidelines. In the control group, GPs were asked to continue the care for people with diabetes as usually. Generalized estimating equations were used to control for the clustered design of the study. RESULTS: In the intervention group, more people were seen on a 3-monthly basis (88% versus 69%, P < 0.001) and more blood pressure and bodyweight measurements were performed every 3 months (blood pressure 83% versus 66%, P < 0.001 and bodyweight 78.9% versus 48.5%, P < 0.001). Apart from a marginal difference in mean cholesterol, differences in HbA1c%, blood pressure, body mass index and treatment satisfaction were not significant. CONCLUSION: Multifaceted implementation of locally adapted shared care guidelines did improve the process of diabetes care but hardly changed intermediate outcomes. In the short term, local adaptation of shared care guidelines does not improve the cardiovascular risks of people with type 2 diabetes.

Overall quality of diabetes care in a defined geographic region: different sides of the same story.

BACKGROUND: In diabetes care, knowledge about what is achievable in primary and secondary care is important. There is a need for an objective method to assess the quality of care in different settings. A quality-of-care summary score has been developed based on process and outcome measures. An adapted version of this score was used to evaluate diabetes management in different settings. AIM: To evaluate the quality of diabetes management in primary and secondary care in a defined geographic region in the Netherlands, using a quality score. DESIGN OF STUDY: Cross-sectional study. SETTING: Thirty general practices in the Netherlands. METHOD: A study of 2042 patients with type 2 diabetes (1640 primary care and 402 secondary care) was conducted. Quality of diabetes management was assessed by a score of process and outcome indicators (range 0-40). Clustering at practice level and differences in patient characteristics (case mix) were taken into account. RESULTS: At the outpatient clinic, patients were younger (mean age 64.1 years, standard deviation (SD)=12.5 years, versus mean age 67.1 years, SD=11.7, P<0.001), had more diabetes-related complications (macrovascular: 39.7% versus 24.3%, P<0.001; and microvascular: 25.9% versus 7.3%, P<0.001), and lower quality-of-life scores (EuroQol-5D: mean=0.60, SD=0.29, versus mean=0.80, SD=0.21, P<0.001). After adjusting for case mix and clustering, there was a weak association between the setting of treatment and haemoglobin A1c (primary care: mean 7.1%, SD=1.1, versus secondary care: mean 7.6%, SD=1.2, P<0.016), and between setting and systolic blood pressure (primary: mean 145.7 mmHg, SD=19.2, versus secondary care: 147.77 mmHg, SD 21.0, P<0.035). Quality-of-care summary scores in primary and secondary care differed significantly, with a higher score in primary care (mean 19.6, SD=8.5 versus, mean 18.1, SD=8.7, P<0.01). However, after adjusting for case mix and clustering, this difference lost significance. CONCLUSION: GPs and internists are treating different categories of patients with type 2 diabetes. However, overall quality of diabetes management in primary and secondary care is equal. There is much room for improvement. Future guidelines may differentiate between different categories of patients.