Pragmatic and Observational Research最新文献

{"title":"Coronary stents and vascular response to implantation: literature review.","authors":"Marta Francesca Brancati, Francesco Burzotta, Carlo Trani, Ornella Leonzi, Claudio Cuccia, Filippo Crea","doi":"10.2147/POR.S132439","DOIUrl":"10.2147/POR.S132439","url":null,"abstract":"<p><p>Drug-eluting stents (DESs) have minimized the limitations of bare-metal stents (BMSs) after percutaneous coronary interventions. Nevertheless, serious concerns remain about possible late complications of stenting, such as stent thrombosis (ST) and in-stent restenosis (ISR), although the introduction of second-generation DESs seems to have softened the phenomenon, compared to the first-generation ones. ST is a potentially catastrophic event, which has been markedly reduced by optimization of stent implantation, novel stent designs, and dual antiplatelet therapy. The exact mechanism to explain its occurrence is under investigation, and, realistically, multiple factors are responsible. ISR of BMSs has been previously considered as a stable condition with an early peak (at 6 months) of intimal hyperplasia, followed by a regression period beyond 1 year. On the contrary, both clinical and histologic studies of DESs have demonstrated evidence of continuous neointimal growth during long-term follow-up, named \"late catch-up\" phenomenon. The acknowledgment that ISR is a relatively benign clinical condition has been recently challenged by evidences which reported that patients with ISR can experience acute coronary syndromes. Intracoronary imaging is an invasive technology that allows identifying features of atherosclerotic plaque of stent implanted and of vascular healing after stenting; it is often used to complete diagnostic coronary angiography and to drive interventional procedures. Intracoronary optical coherence tomography is currently considered a state-of-the-art imaging technique; it provides, compared to intravascular ultrasound, better resolution (at least >10 times), allowing the detailed characterization of the superficial structure of the vessel wall. Imaging studies \"in vivo,\" in agreement with histological findings, suggest that chronic inflammation and/or endothelial dysfunction may induce late de novo \"neoatherosclerosis\" inside both BMSs and DESs. So, neoatherosclerosis has become the prime suspect in the pathogenesis of late stent failure.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"137-148"},"PeriodicalIF":8.9,"publicationDate":"2017-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/81/por-8-137.PMC5516876.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35282237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abortion, an increasing public health concern in Ecuador, a 10-year population-based analysis.","authors":"Esteban Ortiz-Prado,&nbsp;Katherine Simbaña,&nbsp;Lenin Gómez,&nbsp;Anna M Stewart-Ibarra,&nbsp;Lisa Scott,&nbsp;Gabriel Cevallos-Sierra","doi":"10.2147/POR.S129464","DOIUrl":"https://doi.org/10.2147/POR.S129464","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the epidemiology of abortion in Ecuador from 2004 to 2014 and compare the prevalence between the public and the private health care systems.</p><p><strong>Methods: </strong>This is a cross-sectional analysis of the overall mortality and morbidity rate due to abortion in Ecuador, based on public health records and other government databases.</p><p><strong>Results: </strong>From 2004 to 2014, a total of 431,614 spontaneous abortions, miscarriage and other types of abortions were registered in Ecuador. The average annual rate of abortion was 115 per 1,000 live births. The maternal mortality rate was found to be 43 per 100,000 live births.</p><p><strong>Conclusions: </strong>Abortion is a significant and wide-ranging problem in Ecuador. The study supports the perception that in spite of legal restrictions to abortion in Ecuador, women are still terminating pregnancies when they feel they need to do so. The public health system reported >84% of the national overall prevalence.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"129-135"},"PeriodicalIF":8.9,"publicationDate":"2017-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S129464","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35282236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mortality, stroke, and heart failure in atrial fibrillation cohorts after ablation versus propensity-matched cohorts.","authors":"Julian We Jarman,&nbsp;Tina D Hunter,&nbsp;Wajid Hussain,&nbsp;Jamie L March,&nbsp;Tom Wong,&nbsp;Vias Markides","doi":"10.2147/POR.S134777","DOIUrl":"https://doi.org/10.2147/POR.S134777","url":null,"abstract":"<p><strong>Background: </strong>We sought to determine from key clinical outcomes whether catheter ablation of atrial fibrillation (AF) is associated with increased survival.</p><p><strong>Methods and results: </strong>Using routinely collected hospital data, ablation patients were matched to two control cohorts using direct and propensity score methodology. Four thousand nine hundred ninety-one ablation patients were matched 1:1 with general AF controls without ablation. Five thousand four hundred seven ablation patients were similarly matched to controls who underwent cardioversion. We examined the rates of ischemic stroke or transient ischemic attack (stroke/TIA), heart failure hospitalization, and death. Matched populations had very similar comorbidity profiles, including nearly identical CHA₂DS₂-VASc risk distribution (<i>p</i>=0.6948 and <i>p</i>=0.8152 vs general AF and cardioversion cohorts). Kaplan-Meier models showed increased survival after ablation for all outcomes compared with both control cohorts (<i>p</i><0.0001 for all outcomes vs general AF, <i>p</i>=0.0087 for stroke/TIA, <i>p</i><0.0001 for heart failure, and <i>p</i><0.0001 for death vs cardioversion). Cox regression models also showed improved survival after ablation for all outcomes compared with the general AF cohort (hazard ratio [HR]=0.4, 95% confidence interval [95% CI]: 0.3-0.6, <i>p</i><0.0001 for stroke/TIA; HR=0.4, 95% CI: 0.2-0.6, <i>p</i><0.0001 for heart failure; HR=0.1, 95% CI: 0.1-0.1, <i>p</i><0.0001 for death) and the cardioversion cohort (HR=0.6, 95% CI: 0.4-0.9, <i>p</i>=0.0111 for stroke/TIA; HR=0.4, 95% CI: 0.3-0.6, <i>p</i><0.0001 for heart failure; HR=0.3, 95% CI:0.2-0.5, <i>p</i><0.0001 for death).</p><p><strong>Conclusions: </strong>Catheter ablation of AF was associated with very significant reductions in mortality, stroke/TIA, and heart failure compared with a matched general AF population and a matched population who underwent cardioversion. Potential confounding of outcomes was minimized by very tight cohort matching.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"99-106"},"PeriodicalIF":8.9,"publicationDate":"2017-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S134777","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35089020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stroke rates before and after ablation of atrial fibrillation and in propensity-matched controls in the UK.","authors":"Julian We Jarman,&nbsp;Tina D Hunter,&nbsp;Wajid Hussain,&nbsp;Jamie L March,&nbsp;Tom Wong,&nbsp;Vias Markides","doi":"10.2147/POR.S134781","DOIUrl":"https://doi.org/10.2147/POR.S134781","url":null,"abstract":"<p><strong>Background: </strong>We sought to determine whether catheter ablation of atrial fibrillation (AF) is associated with reduced occurrence of ischemic cerebrovascular events.</p><p><strong>Methods and results: </strong>Using routinely collected hospital data, ablation patients were matched to two control cohorts via direct and propensity score matching. A total of 4,991 ablation patients were matched 1:1 to general AF controls with no ablation, and 5,407 ablation patients were similarly matched to controls who underwent cardioversion. Yearly rates of ischemic stroke or transient ischemic attack (stroke/TIA) before and after an index date were compared between cohorts. Index date was defined as the first ablation, the first cardioversion, or the second AF event in the general AF cohort. Matched populations had very similar demographic and comorbidity profiles, including nearly identical CHA₂DS₂-VASc risk distribution (<i>p</i>-values 0.6948 and 0.8152 vs general AF and cardioversion cohorts). Statistical models of stroke/TIA risk in the preindex period showed no difference in annual event rates between cohorts (mean±standard error 0.30% ± 0.08% ablation vs 0.28% ± 0.07% general AF, <i>p</i>=0.8292; 0.37% ± 0.09% ablation vs 0.42% ± 0.08% cardioversion, <i>p</i>=0.5198). Postindex models showed significantly lower annual rates of stroke/TIA in ablation patients compared with each control group over 5 years (0.64% ± 0.11% ablation vs 1.84% ± 0.23% general AF, <i>p</i><0.0001; 0.82% ± 0.15% ablation vs 1.37% ± 0.18% cardioversion, <i>p</i>=0.0222).</p><p><strong>Conclusion: </strong>Matching resulted in cohorts having the same baseline risks and rates of ischemic cerebrovascular events. After the index date, there were significantly lower yearly event rates in the ablation cohort. These results suggest the divergence in outcome rates stems from variance in the treatment pathways beginning at the index date.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"107-118"},"PeriodicalIF":8.9,"publicationDate":"2017-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S134781","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35089021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reduced adherence to antiretroviral therapy is associated with residual low-level viremia.","authors":"Franco Maggiolo,&nbsp;Elisa Di Filippo,&nbsp;Laura Comi,&nbsp;Annapaola Callegaro,&nbsp;Giorgio L Colombo,&nbsp;Sergio Di Matteo,&nbsp;Daniela Valsecchi,&nbsp;Marco Rizzi","doi":"10.2147/POR.S127974","DOIUrl":"https://doi.org/10.2147/POR.S127974","url":null,"abstract":"<p><p>The source and significance of residual low-level viremia (LLV) during combinational antiretroviral therapy (cART) remain a matter of controversy. It is unclear whether residual viremia depends on ongoing release of HIV from the latent reservoir or if viral replication contributes to LLV. We examined the relationship between adherence and LLV. Adherence was estimated by pharmacy refill and dichotomized as ≥95% or <95%. Plasma HIV-RNA was determined, with an ultrasensitive test having a limit of detection of 3 copies/mL at least 2 times over the follow-up period. Patients were grouped according to HIV-RNA over time as K<3: constantly <3 copies/mL; V<3: sometimes below or above the cutoff limit but always <50 copies/mL; K>3: constantly between 3 and 50 copies/mL; and V>50: a measure of >50 copies/mL minimum. Overall, 2789 patients were included. At each time point approximately 92% of the patients presented an HIV-RNA <50 copies/mL and two-thirds of those <3 copies/mL, 34.6% of patients had <3 copies/mL constantly, 32.7% sometimes below or above the cutoff limit but always <50 copies/mL, 9.5% constantly between 3 and 50 copies/mL, and 23.2% a measure of >50 copies/mL minimum. The mean adherence rate was 92.1% (95% confidence interval [CI] from 91.1% to 93.1%) in K<3 patients, similar in V<3 patients (91.9%), but lowered to 88.8% in K>3 patients and to 88.4% in V>50 patients (<i>P</i><0.0001). Approximately 55% of patients in groups K<3 and V<3 showed an adherence rate ≥95%; this proportion lowered to ~51% in K>3 and to 48% in V>50. Moreover, 34% of patients with a steady adherence <95% were categorized as K>3, whereas 21.7% of those with a drug holiday (21.7%) were observed in the V>50 group (<i>P</i>=0.002). A steady viral suppression can occur despite moderate cART non-adherence, but reduced adherence is associated with low-level residual viremia, which could reflect new rounds of HIV replication. However, a detectable HIV-RNA could also be detected in patients with optimal cART adherence, indicating additional mechanisms favoring HIV persistence.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"91-97"},"PeriodicalIF":8.9,"publicationDate":"2017-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S127974","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35078284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database.","authors":"David B Price,&nbsp;Eran Gefen,&nbsp;Gokul Gopalan,&nbsp;Cristiana Miglio,&nbsp;Rosie McDonald,&nbsp;Vicky Thomas,&nbsp;Simon Wan Yau Ming","doi":"10.2147/POR.S132839","DOIUrl":"https://doi.org/10.2147/POR.S132839","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to determine whether the effectiveness of budesonide comparator is non-inferior to budesonide reference in the prevention of asthma exacerbations. Asthma-related hospitalizations and safety were also examined.</p><p><strong>Methods: </strong>This study used a matched, historic cohort design. Data were drawn from the Clinformatics™ Data Mart US claims database and included a 1-year baseline, starting 1 year before the index prescription date, and a 1-year outcome period. Patients received budesonide comparator or reference treatment. The primary outcome was the rate of asthma exacerbations. Non-inferiority for budesonide comparator vs budesonide reference was established if the 95% confidence interval (CI) upper limit of mean difference in proportions between treatments was <15%. Secondary outcomes examined rate of asthma-related hospitalizations and adverse events (AEs).</p><p><strong>Results: </strong>The budesonide comparator and reference-matched cohorts each included 3109 patients. The adjusted upper 95% CI for the difference in proportions of patients experiencing asthma exacerbations was 0.035 (3.5%), demonstrating non-inferiority. Cohorts did not significantly differ in the rate of asthma exacerbations (adjusted rate ratio [RR]=1.04, 95% CI: 0.95-1.14) or rate of asthma-related hospitalizations (adjusted RR=1.10, 95% CI: 0.99-1.24) after adjusting for baseline confounders. No asthma exacerbations occurred during the outcome period in 72.9% of budesonide comparator patients and 71.8% of budesonide reference patients. No asthma-related hospitalizations occurred in 77.9% of patients in the budesonide comparator cohort and 79.0% of patients in the budesonide reference cohort. The most frequent AEs were throat irritation (≤0.4% of patients) and hoarseness/dysphonia (0.02% of patients). AEs did not significantly differ between treatment cohorts.</p><p><strong>Conclusion: </strong>In this real-life study, non-inferiority of the budesonide comparator vs reference was met for the primary end point of asthma exacerbation rates. Asthma-related hospitalization and AE rates did not differ between the two treatment cohorts. The budesonide comparator is an effective and safe treatment alternative for asthma exacerbations.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"69-83"},"PeriodicalIF":8.9,"publicationDate":"2017-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S132839","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35053195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Older patients have increased risk of poor outcomes after low-velocity pedestrian-motor vehicle collisions.","authors":"Gerard A Baltazar,&nbsp;Parker Bassett,&nbsp;Amy J Pate,&nbsp;Akella Chendrasekhar","doi":"10.2147/POR.S127710","DOIUrl":"https://doi.org/10.2147/POR.S127710","url":null,"abstract":"<p><strong>Background: </strong>Motor vehicle collisions (MVCs) are a leading cause of injury in the US. While the probability of collision with a pedestrian (PMVC) has declined in recent years, the probability of a pedestrian fatality has risen. Our objective was to determine whether older age impacts potential outcomes in patients involved in low-velocity PMVCs.</p><p><strong>Materials and methods: </strong>We performed a retrospective-cohort study of adult patients aged >14 years involved in low-velocity pedestrian-MVCs (<15 miles per hour [24.14 km/h]), presenting to an urban level I trauma center from January to November 2013. Subjects were identified via trauma registry and stratified: ages 15-49 years and ≥50 years. Electronic medical records were reviewed for demographics, vital signs, and laboratory results on initial presentation, presence or absence of systemic inflammatory response syndrome (SIRS), shock index (SI), injury-severity score (ISS), length of stay (LOS), and survival to discharge. For statistical analysis, <i>χ</i>² or Student's <i>t</i>-tests were utilized.</p><p><strong>Results: </strong>Our study included 145 patients (77 female) with a mean age of 41.9±3 years; 95 patients were aged 15-49 years (mean 31.9±2.2 years), and 50 patients were aged ≥50 years or older (mean 62.44±2.9 years). Mean ISS was 10.05±1.95, mean SI was 0.68±0.03, and mean LOS was 3.67±0.57 days. A total of 41 patients met SIRS criteria on arrival, and nine patients expired (6.2%). Mean ISS (15.64±4.42 vs 7.1±1.64, <i>P</i><0.001) and mean SI (0.75±0.07 vs 0.65±0.03, <i>P</i>=0.002) were higher in patients aged ≥50 years. Mean LOS was longer in older patients (5.22±1.14 vs 2.85±0.58 days, <i>P</i><0.001). Older age was associated with SIRS on arrival (<i>P</i>=0.023) and associated with mortality (<i>P</i>=0.004).</p><p><strong>Conclusion: </strong>Age ≥50 years is associated with greater severity of injury and poor outcomes for patients involved in low-velocity PMVCs. Increased clinical attention and resource allocation should be directed toward older patients after low-velocity PMVCs.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"43-47"},"PeriodicalIF":8.9,"publicationDate":"2017-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S127710","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34983617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Does co-payment for inhaler devices affect therapy adherence and disease outcomes? A historical, matched cohort study.","authors":"Jaco Voorham,&nbsp;Bernard Vrijens,&nbsp;Job Fm van Boven,&nbsp;Dermot Ryan,&nbsp;Marc Miravitlles,&nbsp;Lisa M Law,&nbsp;David B Price","doi":"10.2147/POR.S132658","DOIUrl":"https://doi.org/10.2147/POR.S132658","url":null,"abstract":"<p><strong>Background: </strong>Adherence to asthma and chronic obstructive pulmonary disease (COPD) treatment has been shown to depend on patient-level factors, such as disease severity, and medication-level factors, such as complexity. However, little is known about the impact of prescription charges - a factor at the health care system level. This study used real-life data to investigate whether co-payment affects adherence (implementation and persistence) and disease outcomes in patients with asthma or COPD.</p><p><strong>Methods: </strong>A matched, historical cohort study was carried out using two UK primary care databases. The exposure was co-payment for prescriptions, which is required for most patients in England but not in Scotland. Two comparison cohorts were formed: one comprising patients registered at general practices in England and the other comprising patients registered in Scotland. Patients aged 20-59 years with asthma, or 40-59 years with COPD, who were initiated on fluticasone propionate/salmeterol xinafoate, were included, matched to patients in the opposite cohort, and followed up for 1 year following fluticasone propionate/salmeterol xinafoate initiation. The primary outcome was good adherence, defined as medication possession ratio ≥80%, and was analyzed using conditional logistic regression. Secondary outcomes included exacerbation rate.</p><p><strong>Results: </strong>There were 1,640 patients in the payment cohort, ie, England (1,378 patients with asthma and 262 patients with COPD) and 619 patients in the no-payment cohort, ie, Scotland (512 patients with asthma and 107 patients with COPD). The proportion of patients with good adherence was 34.3% and 34.9% in the payment and no-payment cohorts, respectively, across both disease groups. In a multivariable model, no difference in odds of good adherence was found between the cohorts (odds ratio, 1.04; 95% confidence interval, 0.85-1.27). There was also no difference in exacerbation rate.</p><p><strong>Conclusion: </strong>There was no difference in adherence between matched patients registered in England and Scotland, suggesting that prescription charges do not have an impact on adherence to treatment.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"31-41"},"PeriodicalIF":8.9,"publicationDate":"2017-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S132658","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34955963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An evaluation of exact matching and propensity score methods as applied in a comparative effectiveness study of inhaled corticosteroids in asthma.","authors":"Anne Burden,&nbsp;Nicolas Roche,&nbsp;Cristiana Miglio,&nbsp;Elizabeth V Hillyer,&nbsp;Dirkje S Postma,&nbsp;Ron Mc Herings,&nbsp;Jetty A Overbeek,&nbsp;Javaria Mona Khalid,&nbsp;Daniela van Eickels,&nbsp;David B Price","doi":"10.2147/POR.S122563","DOIUrl":"https://doi.org/10.2147/POR.S122563","url":null,"abstract":"<p><strong>Background: </strong>Cohort matching and regression modeling are used in observational studies to control for confounding factors when estimating treatment effects. Our objective was to evaluate exact matching and propensity score methods by applying them in a 1-year pre-post historical database study to investigate asthma-related outcomes by treatment.</p><p><strong>Methods: </strong>We drew on longitudinal medical record data in the PHARMO database for asthma patients prescribed the treatments to be compared (ciclesonide and fine-particle inhaled corticosteroid [ICS]). Propensity score methods that we evaluated were propensity score matching (PSM) using two different algorithms, the inverse probability of treatment weighting (IPTW), covariate adjustment using the propensity score, and propensity score stratification. We defined balance, using standardized differences, as differences of <10% between cohorts.</p><p><strong>Results: </strong>Of 4064 eligible patients, 1382 (34%) were prescribed ciclesonide and 2682 (66%) fine-particle ICS. The IPTW and propensity score-based methods retained more patients (96%-100%) than exact matching (90%); exact matching selected less severe patients. Standardized differences were >10% for four variables in the exact-matched dataset and <10% for both PSM algorithms and the weighted pseudo-dataset used in the IPTW method. With all methods, ciclesonide was associated with better 1-year asthma-related outcomes, at one-third the prescribed dose, than fine-particle ICS; results varied slightly by method, but direction and statistical significance remained the same.</p><p><strong>Conclusion: </strong>We found that each method has its particular strengths, and we recommend at least two methods be applied for each matched cohort study to evaluate the robustness of the findings. Balance diagnostics should be applied with all methods to check the balance of confounders between treatment cohorts. If exact matching is used, the calculation of a propensity score could be useful to identify variables that require balancing, thereby informing the choice of matching criteria together with clinical considerations.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"15-30"},"PeriodicalIF":8.9,"publicationDate":"2017-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S122563","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34867253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US","authors":"Danielle M. Fernandes, Allison P Roland, Marilyn C. Morris","doi":"10.2147/POR.S126509","DOIUrl":"https://doi.org/10.2147/POR.S126509","url":null,"abstract":"Objective To explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US. Study design A series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process. Results A total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child’s medical information. A total of 157 parents were asked “Is it okay to tell you about this kind of research using this handout?” – 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86 (52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose “no consent needed”. There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific). Conclusion Few parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 1","pages":"1 - 8"},"PeriodicalIF":8.9,"publicationDate":"2017-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S126509","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68454544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}