Henri E. J. H. Stoffers

The diagnostic value of the measurement of the ankle-brachial systolic pressure index in primary health care☆

We investigated the value of the ankle-brachial systolic pressure index (ABPI) as a test for the diagnosis of peripheral arterial occlusive disease (PAOD) in general practice. ABPI measurements on 231 legs of 117 subjects performed in three general practice centers (GPC) were compared with the diagnostic conclusions of a Vascular Laboratory. The optimum cutoff value for the ABPI, its accuracy and diagnostic value were estimated. In a subpopulation of 51 subjects for whom repeated measurements were available, we checked whether taking the mean of three consecutive ABPIs for test outcome would enhance diagnostic performance. Receiver Operating Characteristic analysis showed that overall performance of the GPC ABPI was good (area under the curve approximately 0.9). Performing repeated ABPI measurements was superior to performing a single measurement. The optimum cutoff value for the ABPI was 0.97, associated with a diagnostic odds ratio (OR) of 17 and an accuracy of 81%. In a somewhat more selected subpopulation, the optimum cutoff value was 0.92 (OR 70, accuracy 90%). On the basis of our results, we suggest the following rule of thumb: if the ABPI < 0.8 or if the mean of three ABPIs < 0.9, it is highly probable that PAOD is present (PV+ > or = 95%); if the ABPI > 1.1 or if the mean of three ABPIs > 1.0, PAOD can be ruled out (PV- > or = 99%). In conclusion, in primary health care, the ABPI measurement can be a useful supplementary test in ambiguous diagnostic situations with regard to PAOD.

Risk factors and cardiovascular diseases associated with asymptomatic peripheral arterial occlusive disease: The Limburg PAOD Study

Objectives - To describe the risk-factor profile and cardiovascular comorbidity of asymptomatic peripheral arterial occlusive disease (PAOD). Design - A cross-sectional survey. Asymptomatic PAOD wa...

Barriers to implementing cardiovascular risk tables in routine general practice.

Design Qualitative study. GPs were interviewed after analysing two audiotaped cardiovascular consultations. Setting Primary health care. Subjects A sample of 15 GPs who audiotaped 22 consultations. Main outcome measures Barriers hampering GPs from following the guideline. Results Data saturation was reached after about 13 interviews. The 25 identified barriers were related to the risk table, the GP or to environmental factors. Lack of knowledge and poor communication skills of the GP, along with pressure of work and demanding patients, cause GPs to deviate from the guideline. GPs regard barriers external to themselves as most important. Conclusion Using the risk table as a key element of the high-risk approach in primary prevention encounters many barriers. Merely incorporating risk tables in guidelines is not sufficient for implementation of the guidelines. Time-efficient implementation strategies dealing in particular with the communication and presentation of cardiovascular risk are needed.

Safely Ruling Out Deep Venous Thrombosis in Primary Care

Context Primary care physicians need office-based methods to rule out suspected deep venous thrombosis (DVT). Contribution The authors conducted a management trial of a prediction rule that uses clinical findings and a point-of-care d-dimer test to identify patients at very low risk for suspected DVT. They managed 1028 patients from approximately 300 primary care practices according to the rule, which identified nearly half (49%) to be at low enough risk to withhold imaging tests and anticoagulation treatment. In 3 months, 1.4% (95% CI, 0.6% to 2.9%) of low-risk patients had venous thromboembolism. Caution There was no control group. Authors relied on symptoms to detect subsequent venous thromboembolism. Implication Office-based methods can safely rule out DVT. The Editors Each year, more than 140000 persons in the United Kingdom present to their primary care physician with signs and symptoms suggestive of deep venous thrombosis (DVT) of the leg (1, 2). Because DVT is a potentially life-threatening disorder, current practice is to refer all patients for diagnostic testing services. These services are readily available, use noninvasive tests (such as, ultrasonography and d-dimer testing), and provide the referring physician with the assurance that DVT is not missed (3, 4). However, many studies have revealed that 80% to 90% of these referred patients do not have DVT (46). Therefore, it would be ideal to safely exclude DVT at initial presentation in a large proportion of these patients and thereby avoid referral. The recent introduction of rapid point-of-care d-dimer assays that can be included in a specific clinical decision rule makes it possible to do a diagnostic work-up in a primary care setting (79). We recently found that the use of a decision ruleinitially developed and validated in secondary carewas not accurate enough for primary care patients suspected of having DVT because the prevalence of thrombosis was still 2.9% among patients with a low probability (based on the Wells score and a normal quantitative d-dimer) compared with 0.9% reported in the original publication by Wells and colleagues (10, 11). Therefore, we developed and validated such a decision rule specifically for the primary care setting (10, 12) that included clinical items and the d-dimer assay result. A major difference between the rules, taking into account the additional use of d-dimer for low-probability patients in the Wells rule, is the replacement of the subjective phrase alternative diagnosis more likely with the more objective phrase absence of leg trauma. In primary care, the category of low probability based on the new rule had a 0.7% prevalence for thrombosis (13). However, as Reilly and Evans (14) recently outlined, development and validation studies should be followed by a prospective impact or management study demonstrating that the rule could be used by physicians to direct care before the rule is implemented in daily practice. Therefore, we conducted this study in a large series of consecutive patients in a primary care setting to evaluate the safety and efficiency of excluding DVT by using a clinical decision rule and a point-of-care d-dimer assay. In addition, we measured the yield of ultrasonography in the referred patients. Methods Study Overview In this prospective study in primary care, we managed patients suspected of having DVT by using a clinical decision rule that included a point-of-care d-dimer test. We did not refer patients with a low probability of DVT for further testing or administer treatment; we followed them for 3 months to record the incidence of venous thromboembolism (10, 12). Setting and Patients We invited the affiliated general practices of the 3 academic centers (who organized the study) to participate. Approximately 300 general practitioners agreed to participate. From March 2005 to January 2007, consecutive patients who presented with clinically suspected DVT were eligible for the study on the basis of the presence of at least 1 of 3 lower extremity symptoms: swelling, redness, or pain. We excluded patients if they were younger than 18 years, received anticoagulant treatment (that is, vitamin K antagonists or low-molecular-weight heparin) at presentation, or declined to participate. We obtained written informed consent, and the local institutional review boards approved the study. Diagnostic Strategy General practitioners applied a clinical decision rule, provided on a worksheet, to all study patients. This clinical decision rule was developed to safely exclude clinically suspected DVT in primary care patients. It included clinical items and a d-dimer assay result (Table 1) (10, 12). Table 1. Clinical Decision Rule Because we aimed to improve the management of patients suspected of having DVT in a primary care setting, we explicitly selected a rapid point-of-care d-dimer assay (Clearview Simplify d-dimer assay, Inverness Medical, Bedford, United Kingdom) (8, 15, 16). This allowed the general practitioner to use the decision rule outside of office hours and during house calls. We drew a capillary blood sample by using the finger-prick method (15). The test result was considered abnormal if, next to the control band, a second band appeared within 10 minutes (15). Participating physicians and their assistants received a single, brief instruction on how to use the d-dimer assay and the clinical rule. Physicians calculated the score for each patient by using the clinical decision rule (Table 1) (10, 12) and managed patients accordingly. Those with a score of 3 or less did not receive anticoagulant treatment or a referral for ultrasonography, but they were instructed to contact their general practitioner if symptoms became worse. Patients with a score of 4 or greater received a referral for ultrasonography. Deep venous thrombosis was considered present when 1 of the proximal veins of the lower extremities was noncompressible on ultrasonography (4). All patients visited their general practitioner between days 5 and 9 for reevaluation. Three months after entering the study, all patients received a questionnaire addressing signs and symptoms of (recurrent) venous thromboembolism. We contacted patients who did not respond (30%) through their general practitioners. If we had any suspicion of a (recurrent) venous thromboembolic event during the 3-month follow-up, based on the information presented in the questionnaire, we retrieved additional medical information of patients from their general practitioners, including letters from hospital specialists. Outcome Measure We defined the primary outcome as the incidence of symptomatic venous thromboembolism during 3-month follow-up. This included fatal pulmonary embolism, nonfatal pulmonary embolism, and DVT. An independent adjudication committee, unaware of the patients result of the clinical decision rule, evaluated all suspected venous thromboembolic events and deaths. A diagnosis of pulmonary embolism or DVT was based on a prioridefined and generally accepted criteria (Appendix Table) (17). Deaths were classified as caused by pulmonary embolism when autopsy was done if an objective test result was positive for pulmonary embolism before death or if pulmonary embolism could not be confidently excluded as the cause of death (17). Appendix Table. Adjudication Criteria Used for the AMUSE Study Statistical Analysis On the basis of an expected incidence of venous thromboembolism in 1% of patients (those with a score 3) during 3-month follow-up and the exclusion of a predetermined incidence of 4% or more, we calculated that 488 patients needed to be included in this low-risk group (type I error, 0.05; type II error, 0.2). The primary analysis was about the incidence (with exact 95% CI) of symptomatic venous thromboembolism during 3-month follow-up in the group of patients with a score of 3 or less who were not referred for further testing or treatment. In addition, we calculated the percentage of patients with a score of 3 or less. Furthermore, we calculated the probability of venous thromboembolism on leg ultrasonography at baseline or during follow-up, according to the results of the clinical decision rule without the d-dimer assay result, as well as the d-dimer assay result alone. For this purpose, a cutoff of 3 or less was also used because on the basis of this cutoff, patients with a negative d-dimer result should still receive a referral for ultrasonography. Role of the Funding Source The study was funded by the Netherlands Organization for Scientific Research. The funding source had no role in the design, conduct, or reporting of the study or in the decision to submit the manuscript for publication. Results Patients We assessed 1086 consecutive patients with clinically suspected DVT. We excluded 58 patients (5.3%) because of predefined exclusion criteria (Figure). Table 2 shows characteristics of the 1028 study patients, including the items of the clinical decision rule. The mean age was 58 years, and 37% were men. Suspicion of DVT that led to study inclusion was based most commonly on leg pain (87%) and leg swelling (78%). Figure. Study flow diagram. CDR = clinical decision rule; DVT = deep venous thrombosis; DVT+ = deep venous thrombosis confirmed by ultrasonography; DVT = deep venous thrombosis excluded by ultrasonography; LMWH = low-molecular-weight heparin; PE = pulmonary embolism; VTE = venous thromboembolism. * All patients were referred for ultrasonography on the day of presentation. No clinical events occurred in this group. Clearview Simplify d-dimer assay, Inverness Medical, Bedford, United Kingdom. Incidence of VTE, 1.4% (95% CI, 0.6% to 2.9%). If the 1 patient lost to follow-up had developed VTE, the percentage missed by the procedure would have been 1.6% instead of 1.4%. Table 2. Demographic and Clinical Characteristics of the Study Sample (n= 1028) Results of the Clinical Decision Rule In 500 of 1028 patients (49%), the score was 3 or les

Safe exclusion of pulmonary embolism using the Wells rule and qualitative D-dimer testing in primary care: prospective cohort study

Objective To validate the use of the Wells clinical decision rule combined with a point of care D-dimer test to safely exclude pulmonary embolism in primary care. Design Prospective cohort study. Setting Primary care across three different regions of the Netherlands (Amsterdam, Maastricht, and Utrecht). Participants 598 adults with suspected pulmonary embolism in primary care. Interventions Doctors scored patients according to the seven variables of the Wells rule and carried out a qualitative point of care D-dimer test. All patients were referred to secondary care and diagnosed according to local protocols. Pulmonary embolism was confirmed or refuted on the basis of a composite reference standard, including spiral computed tomography and three months’ follow-up. Main outcome measures Diagnostic accuracy (sensitivity and specificity), proportion of patients at low risk (efficiency), number of missed patients with pulmonary embolism in low risk category (false negative rate), and the presence of symptomatic venous thromboembolism, based on the composite reference standard, including events during the follow-up period of three months. Results Pulmonary embolism was present in 73 patients (prevalence 12.2%). On the basis of a threshold Wells score of ≤4 and a negative qualitative D-dimer test result, 272 of 598 patients were classified as low risk (efficiency 45.5%). Four cases of pulmonary embolism were observed in these 272 patients (false negative rate 1.5%, 95% confidence interval 0.4% to 3.7%). The sensitivity and specificity of this combined diagnostic approach was 94.5% (86.6% to 98.5%) and 51.0% (46.7% to 55.4%), respectively. Conclusion A Wells score of ≤4 combined with a negative qualitative D-dimer test result can safely and efficiently exclude pulmonary embolism in primary care.

Nurse‐led self‐management group programme for patients with congestive heart failure: randomized controlled trial

AIM This paper reports on of the effects of the Chronic Disease Self-Management Programme on psychosocial attributes, self-care behaviour and quality of life among congestive heart failure patients who experienced slight to marked limitation of physical activity. BACKGROUND Most self-management programmes for congestive heart failure patients emphasize the medical aspects of this chronic condition, without incorporating psychosocial aspects of self-management. The programme has been used with various patient groups, but its effectiveness with congestive heart failure patients when led by pairs of cardiac nurse specialists and peer leaders is unknown. METHOD A randomized controlled trial with 12 months of follow-up from start of the programme was conducted with 317 patients. Control group patients (n = 131) received usual care, consisting of regular outpatient checkups. Intervention group patients (n = 186) received usual care and participated in the six-week self-management programme. The programme teaches patients medical, social and emotional self-management skills. Twenty-one classes were conducted in six hospitals in the Netherlands, and data were collected between August 2004 and January 2007. RESULTS Directly after the programme, statistically significant effects were found for cognitive symptom management (P < 0.001), self-care behaviour (P = 0.008) and cardiac-specific quality of life (P = 0.005). No effects were found at 6- and 12-month follow-up. CONCLUSION Further research is necessary to study how long-term effectiveness of the programme with patients with congestive heart failure can be achieved, and how successful adaptations of the programme can be integrated into standard care.

Peripheral arterial occlusive disease: prognostic value of signs, symptoms, and the ankle-brachial pressure index.

Objectives . To determine whether different levels of the ankle-brachial pressure index (ABPI) are associated with an increased risk for progressive limbischemia, nonfatal and fatal cardiovascular events. To investigate the prognostic value of signs and symptoms associated with peripheral arterial occlusive disease (PAOD). Design . Prospective follow-up study. Setting . Eighteen general practice centers in the Netherlands. Participants . Three thousand six hundred forty-nine participants (53% female) with a mean age of 59 years (range: 40-78 years). Main outcome measures . Progressive limbischemia, cardiovascular morbidity and mortality. Results . At baseline, 458 participants had PAOD, defined as an ABPI < 0.95. Among these, 148 (32.2%) had an ABPI < 0.70. Cox proportional hazards models showed that after a mean follow-up period of 7.2 years, PAOD patients with an ABPI < 0.70 were at higher risk for cardiovascular death, compared with participants with a moderately reduced ABPI (< 0.95 - 0.70): HR 2.3 versus 1.2. Older age, complaints of intermittent claudication, abnormal pedal pulses, elevated blood pressure, and coexisting cardiovascular disease at baseline were also significant independent prognostic factors for one or more of the adverse outcome events in these patients. Conclusion . The ABPI is inversely associated with cardiovascular mortality in PAOD patients. A low ABPI is an independent predictor for cardiovascular mortality in PAOD patients.

Improving cardiovascular risk management: a randomized, controlled trial on the effect of a decision support tool for patients and physicians.

Background There is nonoptimal adherence of general practitioners (GPs) and patients to cardiovascular risk reducing interventions. GPs find it difficult to assimilate multiple risk factors into an accurate assessment of cardiovascular risk. In addition, communicating cardiovascular risk to patients has proved to be difficult. Aims Improving primary prevention of cardiovascular disease (CVD) in primary care by enhancing patient involvement in the use of a decision support tool. Design Cluster randomized trial. Methods Thirty-four GPs included patients (40-75 years old) without CVD. In an interactive, small group training session lasting 4h, the GPs in the intervention group were trained to use the guidelines on cardiovascular risk and a decision support tool. The control group received educational materials about the guidelines on paper. GPs’ clinical performance and patients’ risk perception and self-reported lifestyles were measured at baseline and after 6 months. Results Thirty-four GPs recorded 490 consultations, 276 in the intervention and 214 in the control group. After 6 months, no significant effect of the intervention on the GPs’ performance or the patients’ risk perception was found. There was only an effect on self-reported lifestyle, in that more men in the intervention group than in the control group increased their physical activity (odds ratio 3.8, 95% confidence interval 1.7–8.7). Conclusion The 4-h interactive, small group training did not guarantee correct application of the decision support tool and as such failed to improve GPs’ performance or correct patients’ risk perception. The positive effect on physical activity justifies further research on patient involvement. Eur J Cardiovasc Prev Rehabil 14: 44-50

Effects of ACE I/D and AT1R-A1166C polymorphisms on blood pressure in a healthy normotensive primary care population: first results of the Hippocates study

Background Several studies have assessed the relationship between the angiotensin-converting enzyme (ACE) I/D or angiotensin II type 1 receptor (AT1R)-A1166C polymorphisms and blood pressure (BP). Since most data have been obtained in selected populations, the present study was performed in a healthy normotensive primary care population. Objective To investigate the individual effects of the aforementioned polymorphisms and their interaction on BP. Methods This cross-sectional study included 198 healthy subjects. Office BP was measured and polymorphisms were genotyped (polymerase chain reaction). Polymorphism interaction was tested using the following model: systolic blood pressure (SBP) (or diastolic blood pressure, DBP) = b0 + b1X + b2Y + b3XY, in which X and Y represent the polymorphisms’ risk alleles. Results The ACE I/D polymorphism was associated with SBP (P = 0.002) and DBP (P = 0.004); highest pressures tracked with the DD genotype. Furthermore, in multiple linear regression analysis the ACE D allele was associated with SBP (P = 0.005) and DBP (P = 0.001), when adjusted for body mass index (BMI) and age. With respect to the AT1R-A1166C polymorphism, SBP was highest in the CC genotype (P = 0.025). In linear regression analysis the C allele was not associated with SBP. No synergistic effect of ACE D and AT1R C alleles on BP was found. Nevertheless, highest DBP tracked with the DDCC combination in comparison with other homozygous allele combinations (P = 0.030). Conclusions This study confirmed an association of ACE I/D and AT1R-A1166C polymorphisms with BP in a healthy normotensive primary care population. Although synergistic effect of both polymorphisms on BP does not seem to be present, an additive effect on DBP is likely.

Cost‐effectiveness of ruling out deep venous thrombosis in primary care versus care as usual

Summary.  Background: Referral for ultrasound testing in all patients suspected of DVT is inefficient, because 80–90% have no DVT. Objective: To assess the incremental cost‐effectiveness of a diagnostic strategy to select patients at first presentation in primary care based on a point of care D‐dimer test combined with a clinical decision rule (AMUSE strategy), compared with hospital‐based strategies. Patients/Methods: A Markov‐type cost‐effectiveness model with a societal perspective and a 5‐year time horizon was used to compare the AMUSE strategy with hospital‐based strategies. Data were derived from the AMUSE study (2005–2007), the literature, and a direct survey of costs (2005–2007). Results of base‐case analysis: Adherence to the AMUSE strategy on average results in savings of €138 (