BACKGROUND: Guidelines and accompanying risk charts concerning cardiovascular risk management (CVRM) are regularly revised worldwide. OBJECTIVE: To evaluate whether revision of the Dutch CVRM... Show moreBACKGROUND: Guidelines and accompanying risk charts concerning cardiovascular risk management (CVRM) are regularly revised worldwide. OBJECTIVE: To evaluate whether revision of the Dutch CVRM guideline has led to the reclassification of patients and, accordingly, to changes in drug recommendations. METHODS: All medical records (year 2011) of patients aged 40-65 years with no history of cardiovascular disease (CVD) but using antihypertensive and/or lipid-lowering drugs, were selected from the Registration Network of General Practices associated with Leiden University Medical Center. Multiple imputation techniques for missing determinants were used. The individual cardiovascular risk was calculated and the resulting drug recommendation was assessed according to both the 2006 and 2012 versions of the guideline. RESULTS: In total, 2075 patients were selected, of whom 1248 fulfilled the guideline criteria (systolic blood pressure 115-180 mmHg and total cholesterol/high-density-lipoprotein-cholesterol ratio 3.5-8). According to the 2012 guideline, 58.2% of the patients had low risk and 249 patients (20.0%) shifted to a different risk category. For 150 of these patients (12.0%), this category shift implied a shift in drug recommendation. The probability of shifting in drug recommendation increased with increasing age, cholesterol level, and blood pressure, and by being male. CONCLUSION: Guideline revision may have important implications: based on identical values for risk factors, according to the latest revision of the Dutch CVRM guideline 20% of patients shifted in risk category and 12% of the patients shifted in drug recommendation. Show less
BACKGROUND\nAiming at partly controlled asthma (PCa) instead of controlled asthma (Ca) might decrease asthma medication use. Biomarkers, such as the fraction of exhaled nitric oxide (Feno), allow... Show moreBACKGROUND\nAiming at partly controlled asthma (PCa) instead of controlled asthma (Ca) might decrease asthma medication use. Biomarkers, such as the fraction of exhaled nitric oxide (Feno), allow further tailoring of treatment.\nOBJECTIVE\nWe sought to assess the cost-effectiveness and clinical effectiveness of pursuing PCa, Ca, or Feno-driven controlled asthma (FCa).\nMETHODS\nIn a nonblind, pragmatic, cluster-randomized trial in primary care, adults (18-50 years of age) with a doctor's diagnosis of asthma who were prescribed inhaled corticosteroids were allocated to one of 3 treatment strategies: (1) aiming at PCa (Asthma Control Questionnaire [ACQ] score <1.50); (2) aiming at Ca (ACQ score <0.75); and (3) aiming at FCa (ACQ score <0.75 and Feno value <25 ppb). During 12 months' follow-up, treatment was adjusted every 3 months by using an online decision support tool. Outcomes were incremental cost per quality-adjusted life year gained, asthma control (ACQ score), quality of life (Asthma Quality of Life Questionnaire score), asthma medication use, and severe exacerbation rate.\nRESULTS\nSix hundred eleven participants were allocated to the PCa (n = 219), Ca (n = 203), or FCa (n = 189) strategies. The FCa strategy improved asthma control compared with the PCa strategy (P < .02). There were no differences in quality of life (P ≥ .36). Asthma medication use was significantly lower for the PCa and FCa strategies compared with the Ca strategy (medication costs: PCa, $452; Ca, $551; and FCa, $456; P ≤ .04). The FCa strategy had the highest probability of cost-effectiveness at a willingness to pay of $50,000/quality-adjusted life year (86%; PCa, 2%; Ca, 12%). There were no differences in severe exacerbation rate.\nCONCLUSION\nA symptom- plus Feno-driven strategy reduces asthma medication use while sustaining asthma control and quality of life and is the preferred strategy for adult asthmatic patients in primary care. Show less
BACKGROUND Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated... Show moreBACKGROUND Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care. METHODS/DESIGN RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other's experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss. DISCUSSION This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population. TRIAL REGISTRATION Netherlands Trial Register (NTR): NTR2268. Show less
BACKGROUND In people with chronic obstructive pulmonary disease (COPD) there is considerable variation in symptoms, limitations and well-being, which often complicates medical care. To improve... Show moreBACKGROUND In people with chronic obstructive pulmonary disease (COPD) there is considerable variation in symptoms, limitations and well-being, which often complicates medical care. To improve quality of life (QoL) and exercise tolerance, while reducing the number of exacerbations, a multidisciplinary program including different elements of care is needed. OBJECTIVES To evaluate the effects of integrated disease management (IDM) programs or interventions in people with COPD on health-related QoL, exercise tolerance and number of exacerbations. SEARCH METHODS We searched the Cochrane Airways Group Register of trials, CENTRAL, MEDLINE, EMBASE and CINAHL for potentially eligible studies (last searched 12 April 2012). SELECTION CRITERIA Randomized controlled trials evaluating IDM programs for COPD compared with controls were included. Included interventions consisted of multidisciplinary (two or more health care providers) and multi-treatment (two or more components) IDM programs with a duration of at least three months. DATA COLLECTION AND ANALYSIS Two review authors independently assessed trial quality and extracted data; if required, we contacted authors for additional data. We performed meta-analyses using random-effects modeling. We carried out sensitivity analysis for allocation concealment, blinding of outcome assessment, study design and intention-to-treat analysis. MAIN RESULTS A total of 26 trials involving 2997 people were included, with a follow-up ranging from 3 to 24 months. Studies were conducted in 11 different countries. The mean age of the included participants was 68 years, 68% were male and the mean forced expiratory volume in one second (FEV1)% predicted value was 44.3% (range 28% to 66%). Participants were treated in all types of healthcare settings: primary (n = 8), secondary (n = 12), tertiary care (n = 1), and in both primary and secondary care (n = 5). Overall, the studies were of high to moderate methodological quality.Compared with controls, IDM showed a statistically and clinically significant improvement in disease-specific QoL on all domains of the Chronic Respiratory Questionnaire after 12 months: dyspnea (mean difference (MD) 1.02; 95% confidence interval (CI) 0.67 to 1.36); fatigue (MD 0.82; 95% CI 0.46 to 1.17); emotional (MD 0.61; 95% CI 0.26 to 0.95) and mastery (MD 0.75; 95% CI 0.38 to 1.12). The St. George's Respiratory Questionnaire (SGRQ) for QoL reached the clinically relevant difference of four units only for the impact domain (MD -4.04; 95% CI -5.96 to -2.11, P < 0.0001). IDM showed a significantly improved disease-specific QoL on the activity domain of the SGRQ: MD -2.70 (95% CI -4.84 to -0.55, P = 0.01). There was no significant difference on the symptom domain of the SGRQ: MD -2.39 (95% CI -5.31 to 0.53, P = 0.11). According to the GRADE approach, quality of evidence on the SGRQ was scored as high quality, and on the CRQ as moderate quality evidence. Participants treated with an IDM program had a clinically relevant improvement in six-minute walking distance of 43.86 meters compared with controls after 12 months (95% CI 21.83 to 65.89; P < 0.001, moderate quality). There was a reduction in the number of participants with one or more hospital admissions over three to 12 months from 27 per 100 participants in the control group to 20 (95% CI 15 to 27) per 100 participants in the IDM group (OR 0.68; 95% CI 0.47 to 0.99, P = 0.04; number needed to treat = 15). Hospitalization days were significantly lower in the IDM group compared with controls after 12 months (MD -3.78 days; 95% CI -5.90 to -1.67, P < 0.001). Admissions and hospital days were graded as high quality evidence. No adverse effects were reported in the intervention group. No difference between groups was found on mortality (OR 0.96; 95%CI 0.52 to 1.74). There was insufficient evidence to refute or confirm the long term effectiveness of IDM. AUTHORS' CONCLUSIONS In these COPD participants, IDM not only improved disease-specific QoL and exercise capacity, but also reduced hospital admissions and hospital days per person. Show less
Verbiest, M.E.A.; Crone, M.R.; Scharloo, M.; Chavannes, N.H.; Meer, V. van der; Kaptein, A.A.; Assendelft, W.J.J. 2013
INTRODUCTION This study examined the effectiveness of low-intensity, practice-tailored training for general practitioners (GPs) aimed at personal and organizational barriers that arise when... Show moreINTRODUCTION This study examined the effectiveness of low-intensity, practice-tailored training for general practitioners (GPs) aimed at personal and organizational barriers that arise when routinely asking patients' smoking status, advising to quit, and arranging follow-up. METHODS A cluster-randomized controlled trial with 49 GPs and 3,401 patients (677 smokers). Two patient groups participated: 2,068 patients (433 smokers) at baseline and 1,333 patients (244 smokers) postintervention. At follow-up, 225 smokers of both groups participated. The primary outcome was GP smoking cessation counseling (asking about smoking status, advising to quit, prescribing pharmacotherapy, and referring for behavioral support). Secondary outcomes were GPs' attitudes toward smoking cessation care, patients' intention to quit, and long-term quit rates. Outcomes were measured with GP self-report and patient report. RESULTS Patients of trained GPs reported more often being asked about smoking behavior compared to patients of untrained GPs (OR = 1.94, 95% CI = 1.45-2.60). According to GP self-report, the training increased the provision of quit-smoking advices (difference 0.56 advice per day; 95% CI = 0.13-0.98) and the ability and intention of providing smoking cessation care. We found no effect on GPs' arrangement of follow-up, smokers' intention to quit, and long-term quit rates. CONCLUSIONS After 1 hour of training, we found significant differences between trained and untrained GPs on the frequency in which they asked about smoking (patient reported) and advised smokers to quit (GP self-reported). The training did not increase prescriptions of pharmacotherapy, referrals to behavioral support, or quit rates. Future training methods should focus on the GPs' ability, tools, and skills to arrange follow-up to ensure intensive smoking cessation support. Show less
OBJECTIVE To interpret questionnaire scores, clinicians and researchers need to know what change in score reflects a meaningful change in the condition of an individual patient, and what difference... Show moreOBJECTIVE To interpret questionnaire scores, clinicians and researchers need to know what change in score reflects a meaningful change in the condition of an individual patient, and what difference reflects a meaningful difference between groups. These values differ between different populations. We determined the within-person minimally important change (MIC) and the between-group minimally important difference (MID) of the Headache Impact Test-6 (HIT-6) questionnaire in a primary-care population of migraine patients. METHODS We included 490 patients who participated in a clinical trial on the treatment of migraine in primary care. We compared their change scores on the HIT-6 questionnaire between baseline and at three-months follow-up with the answers to two anchor questions according to the 'mean change approach' and the 'ROC curve approach'. RESULTS The within-person MIC was estimated to be between -2.5 points (mean change approach) and -6 points (ROC curve approach). The choice for the within-person MIC value depends on the consequences of false positives and false negatives in a particular setting. The between-group MID was estimated at -1.5 points. CONCLUSIONS We determined the within-person MIC and between-group MID for the HIT-6 in a primary-care population of migraine patients. We recommend the use of these values for clinical care and for research. Show less
AIMS To examine the impact of two national tobacco control interventions in the past decade on (dispensed) prescriptions of stop-smoking medication. DESIGN Ecological study with interrupted time... Show moreAIMS To examine the impact of two national tobacco control interventions in the past decade on (dispensed) prescriptions of stop-smoking medication. DESIGN Ecological study with interrupted time-series analyses of quarterly data points of three nation-wide representative databases. SETTING The Netherlands 2001-2012, with the introduction of the guideline for smoking cessation care for general practitioners (GP) in 2007 and full insurance coverage for smoking cessation treatment in 2011. PARTICIPANTS GPs, pharmacists and people in the general population aged 15 years and older. MEASUREMENTS Time-series plots were inspected visually and segmented regression analyses were performed to estimate the change in level and slope of (dispensed) prescriptions of stop-smoking medication and smoking prevalence in the years preceding and after the tobacco control interventions. FINDINGS No measurable effects of the GP guideline on (dispensed) prescriptions were observed. Shortly after the start of health insurance coverage, an estimated increase in primary care prescriptions of 6.3 per 1000 smokers [95% confidence interval (CI) = 2.9-9.8; P = 0.001] and 17.3 dispensed items per 1000 smokers (95% CI = 12.5-22.0; P < 0.000) was accompanied by a sudden drop in smoking prevalence of 2.9% (95% CI = 4.6-1.1; P = 0.002) in the first quarter of 2011. Immediately after the coverage abolition, smoking prevalence increased by 1.2% (95% CI = 0.5-2.8; P = 0.156) and dispensed prescription rates decreased with 21.6 per 1000 smokers (95% CI = 26.0-17.2; P < 0.000). CONCLUSIONS Full health insurance coverage for smoking cessation treatment in the Netherlands was accompanied by a significant increase in the number of (dispensed) prescriptions of stop-smoking medication and a decrease in smoking prevalence. Show less
