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Prior work suggests a threshold of four courses/year of systemic corticosteroid (SCS) therapy is associated with adverse consequences. The objective of this study was to investigate the onset of adverse outcomes beginning at SCS initiation in a broad asthma population. This historical matched cohort study utilized anonymized, longitudinal medical record data (1984-2017) of patients (≥18 years) with active asthma. Matched patients with first SCS prescription (SCS arm) and no SCS exposure (non-SCS arm) were followed until first outcome event. Associations between time-varying exposure measures and onset of 17 SCS-associated adverse outcomes were estimated using Cox proportional hazard regression, adjusting for confounders, in separate models. We matched 24,117 pairs of patients with median record availability before SCS initiation of 9.9 and 8.7 years and median follow-up 7.4 and 6.4 years in SCS and non-SCS arms, respectively. Compared with patients in the non-SCS arm, patients prescribed SCS had significantly increased risk of osteoporosis/osteoporotic fracture (adjusted hazard ratio 3.11; 95% CI 1.87-5.19), pneumonia (2.68; 2.30-3.11), cardio-/cerebrovascular diseases (1.53; 1.36-1.72), cataract (1.50; 1.31-1.73), sleep apnea (1.40; 1.04-1.86), renal impairment (1.36; 1.26-1.47), depression/anxiety (1.31; 1.21-1.41), type 2 diabetes (1.26; 1.15-1.37), and weight gain (1.14; 1.10-1.18). A dose-response relationship for cumulative SCS exposure with most adverse outcomes began at cumulative exposures of 1.0-<2.5 g and for some outcomes at cumulative exposures of only 0.5-<1 g (vs >0-<0.5 g reference), equivalent to four lifetime SCS courses. Our findings suggest urgent need for reappraisal of when patients need specialist care and consideration of nonsteroid therapy.

BackgroundLittle is known about the impact of exacerbations on COPD progression or whether inhaled corticosteroid (ICS) use and blood eosinophil count (BEC) affect progression. We aimed to assess this in a prospective observational study.MethodsThe study population included patients with mild to moderate COPD, aged ≥35 years, with a smoking history, who were followed up for ≥3 years from first to last spirometry recording using two large UK electronic medical record databases: Clinical Practice Research Datalink (CPRD) and Optimum Patient Care Research Database (OPCRD). Multilevel mixed-effects linear regression models were used to determine the relationship between annual exacerbation rate following initiation of therapy (ICS vs non-ICS) and FEV1 decline. Effect modification by blood eosinophils was studied through interaction terms.ResultsOf 12178 patients included (mean age 66 years; 48% female), 8981 (74%) received ICS. In patients with BEC ≥350 cells/µL not on ICS, each exacerbation was associated with subsequent acceleration of FEV1 decline of 19.4 mL/year (95% CI 12.0 to 26.7, p<0.0001). This excess decline was reduced by 15.1 mL/year (6.6 to 23.6) to 4.3 mL/year (1.9 to 6.7, p<0.0001) in those with BEC ≥350 cells/µL treated with ICS.ConclusionExacerbations are associated with a more rapid loss of lung function among COPD patients with elevated blood eosinophils, defined as ≥350 cells/µL, not treated with ICS. More aggressive prevention of exacerbations using ICS in such patients may prevent excess loss of lung function.

Background Correct inhaler use depends on a complex interplay of factors, including device preparation and generating sufficient inspiratory flow. It is currently unknown which inhalation technique errors can be considered critical in Chronic Obstructive Pulmonary Disease (COPD) patients on Dry Powder Inhaler (DPI) maintenance therapy. Objective To investigate the association between inhalation technique errors and health status or exacerbations in patients with COPD. Additionally, the association between the number of errors and COPD outcomes was determined. Methods The PIFotal study is a cross-sectional multi-country observational study in a primary care setting, including 1434 COPD patients aged ≥ 40 years (50.1% female; mean age 69.2 yrs) using a DPI for their maintenance therapy. Inhalation technique was video recorded and scored by two independent researchers using inhaler-specific checklists. Health status was assessed with two questionnaires; the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The number of moderate and severe exacerbations in the past 12 months was recorded. Critical errors were identified based on their association with health status or exacerbations through multi-level prediction models adjusted for identified confounding. Results Errors in inhalation technique steps ‘Breathe in’, ‘Hold breath’, and ‘Breathe out calmly after inhalation’ were significantly associated with poorer CCQ and CAT outcomes and thus deemed critical. None of the errors were significantly associated with moderate exacerbations. Patients with errors ‘Preparation’, ‘Hold inhaler in correct position during inhalation’, and ‘Breathe in’ had significantly more severe exacerbations, and therefore these errors were also deemed critical. 81.3% of patients with COPD made at least one critical error. Specific combinations of errors were associated with worse outcomes. The more inhalation technique errors identified, the poorer the health status and the higher the exacerbation rate. Conclusion In this study, we identified multiple critical inhalation technique errors in COPD patients using DPIs each associated with poorer outcomes. Explorative analysis revealed that specific combinations of errors may be of clinical relevance, especially those related to the inhalation manoeuvre. COPD outcomes worsened with increasing error count. These results warrant further prospective longitudinal studies to establish the effect of correcting these errors on COPD control. Trial registration https://clinicaltrials.gov/ct2/show/NCT04532853 (31/08/2020)

Some studies suggest an association between onset and/or poor control of type 2 diabetes mellitus and inhaled corticosteroid (ICS) therapy for chronic obstructive pulmonary disease (COPD), and also between increased fracture risk and ICS therapy; however, study results are contradictory and these associations remain tentative and incompletely characterized. This matched cohort study used two large UK databases (1983–2016) to study patients (≥ 40 years old) initiating ICS or long-acting bronchodilator (LABD) for COPD from 1990–2015 in three study cohorts designed to assess the relation between ICS treatment and (1) diabetes onset (N = 17,970), (2) diabetes progression (N = 804), and (3) osteoporosis onset (N = 19,898). Patients had ≥ 1-year baseline and ≥ 2-year outcome data. Matching was via combined direct matching and propensity scores. Conditional proportional hazards regression, adjusting for residual confounding after matching, was used to compare ICS vs. LABD and to model ICS exposures. Median follow-up was 3.7–5.6 years/treatment group. For patients prescribed ICS, compared with LABD, the risk of diabetes onset was significantly increased (adjusted hazard ratio 1.27; 95% CI, 1.07–1.50), with overall no increase in risk of diabetes progression (adjusted hazard ratio 1.04; 0.87–1.25) or osteoporosis onset (adjusted hazard ratio 1.13; 0.93–1.39). However, the risks of diabetes onset, diabetes progression, and osteoporosis onset were all significantly increased, with evident dose–response relationships for all three outcomes, at mean ICS exposures of 500 µg/day or greater (vs. < 250 µg/day, fluticasone propionate–equivalent). Long-term ICS therapy for COPD at mean daily exposure of ≥ 500 µg is associated with an increased risk of diabetes, diabetes progression, and osteoporosis.

Landmark clinical trials have led to optimal treatment recommendations for patients with diabetes. Whether optimal treatment is actually delivered in practice is even more important than the efficacy of the drugs tested in trials. To this end, treatment quality indicators have been developed and tested against intermediate outcomes. No studies have tested whether these treatment quality indicators also predict hard patient outcomes. A cohort study was conducted using data collected from >10.000 diabetes patients in the Groningen Initiative to Analyze Type 2 Treatment (GIANTT) database and Dutch Hospital Data register. Included quality indicators measured glucose-, lipid-, blood pressure- and albuminuria-lowering treatment status and treatment intensification. Hard patient outcome was the composite of cardiovascular events and all-cause death. Associations were tested using Cox regression adjusting for confounding, reporting hazard ratios (HR) with 95% confidence intervals. Lipid and albuminuria treatment status, but not blood pressure lowering treatment status, were associated with the composite outcome (HR = 0.77, 0.67-0.88; HR = 0.75, 0.59-0.94). Glucose lowering treatment status was associated with the composite outcome only in patients with an elevated HbA1c level (HR = 0.72, 0.56-0.93). Treatment intensification with glucose-lowering but not with lipid-, blood pressure- and albuminuria-lowering drugs was associated with the outcome (HR = 0.73, 0.60-0.89). Treatment quality indicators measuring lipid- and albuminuria-lowering treatment status are valid quality measures, since they predict a lower risk of cardiovascular events and mortality in patients with diabetes. The quality indicators for glucose-lowering treatment should only be used for restricted populations with elevated HbA1c levels. Intriguingly, the tested indicators for blood pressure-lowering treatment did not predict patient outcomes. These results question whether all treatment indicators are valid measures to judge quality of health care and its economics.

Comorbidity is often mentioned as interfering with \"optimal\" treatment decisions in diabetes care. It is suggested that diabetes-related comorbidity will increase adequate treatment, whereas diabetes-unrelated comorbidity may decrease this process of care. We hypothesized that these effects differ according to expected priority of the conditions. We evaluated the relationship between comorbidity and treatment intensification in a study of 11,248 type 2 diabetes patients using the GIANTT (Groningen Initiative to Analyse type 2 diabetes Treatment) database. We formed a cohort of patients with a systolic blood pressure ≥ 140 mmHg (6,820 hypertensive diabetics), and a cohort of patients with an HbA1c ≥ 7% (3,589 hyperglycemic diabetics) in 2007. We differentiated comorbidity by diabetes-related or unrelated conditions and by priority. High priority conditions include conditions that are life-interfering, incident or requiring new medication treatment. We performed Cox regression analyses to assess association with treatment intensification, defined as dose increase, start, or addition of drugs. In both the hypertensive and hyperglycemic cohort, only patients with incident diabetes-related comorbidity had a higher chance of treatment intensification (HR 4.48, 2.33-8.62 (p<0.001) for hypertensives; HR 2.37, 1.09-5.17 (p = 0.030) for hyperglycemics). Intensification of hypertension treatment was less likely when a new glucose-regulating drug was prescribed (HR 0.24, 0.06-0.97 (p = 0.046)). None of the prevalent or unrelated comorbidity was significantly associated with treatment intensification. Diabetes-related comorbidity induced better risk factor treatment only for incident cases, implying that appropriate care is provided more often when complications occur. Diabetes-unrelated comorbidity did not affect hypertension or hyperglycemia management, even when it was incident or life-interfering. Thus, the observed \"undertreatment\" in diabetes care cannot be explained by constraints caused by such comorbidity.

Low rates of treatment modification in patients with insufficiently controlled risk factors are common in type 2 diabetes. Although adherence problems are often mentioned in surveys as a reason for not intensifying treatment, observational studies have shown inconclusive results. To assess how medication adherence affects treatment modifications for hypertension and hyperglycemia in patients with type 2 diabetes. This was a cohort study of 11,268 primary care patients with type 2 diabetes in the Netherlands. Inclusion criteria were diagnosis before 2007, ≥1 prescription to antihypertensive or glucose-regulating medication in the preceding 6 months, and a systolic blood pressure level ≥140 mm Hg or glycosylated hemoglobin ≥7% in 2007. Patients on maximal treatment were excluded. Treatment modifications as observed from prescriptions were classified as none, dose increase, dose decrease, class switch, class addition, or class discontinuation. Refill adherence was assessed as medication possession ratio or length of last gap between refills. We performed multilevel multinomial regression analysis to test for associations. We included 4980 diabetic patients with elevated blood pressure and 2945 diabetic patients with elevated glycosylated hemoglobin levels. Patients with lower adherence for antihypertensive drugs were more likely to have those medications discontinued (odds ratio [OR] for every 10% lower medication possession ratio =1.22; 95% CI, 1.11–1.33) or the dose decreased (OR = 1.14; CI 1.01–1.28). For glucose-regulating medication, dose increases (OR = 0.92; 95% CI, 0.85–0.98) and medication additions (OR = 0.90; 95% CI, 0.82–0.99) were less likely in patients with lower adherence levels. Low adherence inhibits the intensification of glucose-regulating but not antihypertensive medication in type 2 diabetic patients with insufficiently controlled risk factors in the Netherlands. Adherence problems may lead to diminished or even discontinued antihypertensive treatment.

Background To improve risk factor management in diabetes, we need to support effective interactions between patients and healthcare providers. Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes, and is intended to empower patients in taking a proactive role in their disease management. Important features are: (1) involving patients in setting goals together with their provider; (2) encourage them to prioritise on treatments that maximise relevant outcomes; and (3) integration of the decision aid in the practice setting and workflow. As secondary aim, we want to evaluate the impact of different presentation formats, and learn more from the experiences of the healthcare providers and patients with the decision aid. Methods and design We will conduct a randomised trial comparing four formats of the decision aid in a 2×2 factorial design with a control group. Patients with type 2 diabetes managed in 18 to 20 primary care practices in The Netherlands will be recruited. Excluded are patients with a recent myocardial infarction, stroke, heart failure, angina pectoris, terminal illness, cognitive deficits, >65 years at diagnosis, or not able to read Dutch. The decision aid is offered to the patients immediately before their quarterly practice consultation. The same decision information will be available to the healthcare provider for use during consultation. In addition, the providers receive a set of treatment cards, which they can use to discuss the benefits and risks of different options. Patients in the control group will receive care as usual. We will measure the effect of the intervention on patient empowerment, satisfaction with care, beliefs about medication, negative emotions, health status, prescribed medication, and predicted cardiovascular risk. Data will be collected with questionnaires and automated extraction from medical records in 6 months before and after the intervention. Discussion This decision aid is innovative in supporting patients and their healthcare providers to make shared decisions about multiple treatments, using the patient’s data from electronic medical records. The results can contribute to the further development and implementation of electronic decision support tools for the management of chronic diseases. Trial registration Dutch Trial register NTR1942 .

Objective To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions.Design Pragmatic randomised controlled trial.Setting 18 general practices in the north of the Netherlands.Participants 344 patients with type 2 diabetes aged ≤65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012: 225 were allocated to the intervention group and 119 to the usual care group.Intervention The intervention comprised a decision aid for people with diabetes, with individually tailored risk information and treatment options for multiple risk factors. The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions. It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation. Four different formats of the decision aid were included for additional explorative analyses.Main outcome measures The primary outcome was the effects on patient empowerment for setting and achieving goals. The secondary outcomes were changes in the prescribing of drugs to regulate glucose, blood pressure, lipids, and albuminuria. Data were collected through structured questionnaires and automated data extraction from electronic health records during six months before and after the intervention.Results Of all intervention participants, 103 (46%) reported to have received the basic elements of the intervention. For the primary outcome analysis, 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included. The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group, which was not significantly different from that of the control group (mean difference after adjusting for baseline 0.039, 95% confidence interval −0.056 to 0.134). Lipid regulating drug treatment was intensified in 25% of intervention and 12% of control participants with increased cholesterol levels, which did not reach significance when the intervention was compared with the usual care group (odds ratio 2.54, 95% confidence interval 0.89 to 7.23). Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care (3.90, 1.29 to 11.80). No relevant or significant changes were seen for other treatments.Conclusion We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount. The aid was not used to its full extent in a substantial number of participants.Trial registration Dutch trial register NTR1942.

Undertreatment of risk factors in patients with type 2 diabetes is common. We assessed the influence of elevated levels of blood pressure, total cholesterol, and A1C on decisions of Dutch general practitioners to change drug treatment in a cohort of 3,029 patients during a 1-year period. Respectively, 58, 71, and 21% of patients remained untreated despite poor blood pressure, lipid levels, and glycemic control. Of poorly controlled but already drug-treated patients, 52% did not receive intensification for antihypertensive medication, 81% not for lipid-lowering medication, and 43% not for glucose-lowering medication. We observed a significantly lower treatment intervention rate in moderately than in poorly controlled patients for blood pressure. This was not seen for decisions on cholesterol or A1C results. The low overall action rates observed for blood pressure and especially lipid management cannot sufficiently be explained by the use of treatment thresholds higher than those indicated by guidelines.