Pragmatic and Observational Research最新文献

{"title":"A validation of clinical data captured from a novel Cancer Care Quality Program directly integrated with administrative claims data.","authors":"David M Kern,&nbsp;John J Barron,&nbsp;Bingcao Wu,&nbsp;Alex Ganetsky,&nbsp;Vincent J Willey,&nbsp;Ralph A Quimbo,&nbsp;Michael J Fisch,&nbsp;Joseph Singer,&nbsp;Ann Nguyen,&nbsp;Ronac Mamtani","doi":"10.2147/POR.S140579","DOIUrl":"https://doi.org/10.2147/POR.S140579","url":null,"abstract":"<p><strong>Background: </strong>Data from a Cancer Care Quality Program are directly integrated with administrative claims data to provide a level of clinical detail not available in claims-based studies, and referred to as the HealthCore Integrated Research Environment (HIRE)-Oncology data. This study evaluated the validity of the HIRE-Oncology data compared with medical records of breast, lung, and colorectal cancer patients.</p><p><strong>Methods: </strong>Data elements included cancer type, stage, histology (lung only), and biomarkers. A sample of 300 breast, 200 lung, and 200 colorectal cancer patients within the HIRE-Oncology data were identified for medical record review. Statistical measures of validity (agreement, positive predictive value [PPV], negative predictive value [NPV], sensitivity, specificity) were used to compare clinical information between data sources, with medical record data considered the gold standard.</p><p><strong>Results: </strong>All 300 breast cancer records reviewed were confirmed breast cancer, while 197 lung and 197 colorectal records were confirmed (PPV =0.99 for each). The agreement of disease stage was 85% for breast, 90% for lung, and 94% for colorectal cancer. The agreement of lung cancer histology (small cell vs non-small cell) was 97%. Agreement of progesterone receptor, estrogen receptor, and human epidermal growth factor receptor 2 status biomarkers in breast cancer was 92%, 97%, and 92%, respectively; epidermal growth factor receptor and anaplastic lymphoma kinase agreement in lung was 97% and 92%, respectively; and agreement of KRAS status in colorectal cancer was 95%. Measures of PPV, NPV, sensitivity, and specificity showed similarly strong evidence of validity.</p><p><strong>Conclusion: </strong>Good agreement between the HIRE-Oncology data and medical records supports the validity of these data for research.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"149-155"},"PeriodicalIF":8.9,"publicationDate":"2017-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S140579","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35396860","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":"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":"Effective deployment of technology-supported management of chronic respiratory conditions: a call for stakeholder engagement.","authors":"Richard W Costello,&nbsp;Alexandra L Dima,&nbsp;Dermot Ryan,&nbsp;R Andrew McIvor,&nbsp;Kay Boycott,&nbsp;Alison Chisholm,&nbsp;David Price,&nbsp;John D Blakey","doi":"10.2147/POR.S132316","DOIUrl":"https://doi.org/10.2147/POR.S132316","url":null,"abstract":"<p><strong>Background: </strong>Healthcare systems are under increasing strain, predominantly due to chronic non-communicable diseases. Connected healthcare technologies are becoming ever more capable and their components cheaper. These innovations could facilitate both self-management and more efficient use of healthcare resources for common respiratory diseases such as asthma and chronic obstructive pulmonary disease. However, newer technologies can only facilitate major changes in practice, and cannot accomplish them in isolation.</p><p><strong>Focus of review: </strong>There are now large numbers of devices and software offerings available. However, the potential of such technologies is not being realised due to limited engagement with the public, clinicians and providers, and a relative paucity of evidence describing elements of best practice in this complex and evolving environment. Indeed, there are clear examples of wasted resources and potential harm. We therefore call on interested parties to work collaboratively to begin to realize the potential benefits and reduce the risks of connected technologies through change in practice. We highlight key areas where such partnership can facilitate the effective and safe use of technology in chronic respiratory care: developing data standards and fostering inter-operability, making collaborative testing facilities available at scale for small to medium enterprises, developing and promoting new adaptive trial designs, developing robust health economic models, agreeing expedited approval pathways, and detailed planning of dissemination to use.</p><p><strong>Conclusion: </strong>The increasing capability and availability of connected technologies in respiratory care offers great opportunities and significant risks. A co-ordinated collaborative approach is needed to realize these benefits at scale. Using newer technologies to revolutionize practice relies on widespread engagement and cannot be delivered by a minority of interested specialists. Failure to engage risks a costly and inefficient chapter in respiratory care.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"119-128"},"PeriodicalIF":8.9,"publicationDate":"2017-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S132316","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35195111","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":"Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial.","authors":"Benton R Hunter,&nbsp;Sean P Collins,&nbsp;Gregory J Fermann,&nbsp;Phillip D Levy,&nbsp;Changyu Shen,&nbsp;Syed Imran Ayaz,&nbsp;Mette L Cole,&nbsp;Karen F Miller,&nbsp;Adam A Soliman,&nbsp;Peter S Pang","doi":"10.2147/POR.S130807","DOIUrl":"https://doi.org/10.2147/POR.S130807","url":null,"abstract":"<p><strong>Background: </strong>Acute heart failure (AHF) is a common presentation in the Emergency Department (ED), and most patients are admitted to the hospital. Identification of patients with AHF who have a low risk of adverse events and are suitable for discharge from the ED is difficult, and an objective tool would be useful.</p><p><strong>Methods: </strong>The highly sensitive Troponin T Rules Out Acute Cardiac Insufficiency Trial (TACIT) will enroll ED patients being treated for AHF. Patients will undergo standard ED evaluation and treatment. High-sensitivity troponin T (hsTnT) will be drawn at the time of enrollment and 3 hours after the initial draw. The initial hsTnT draw will be no more than 3 hours after initiation of therapy for AHF (vasodilator, loop diuretic, noninvasive ventilation). Treating clinicians will be blinded to hsTnT results. We will assess whether hsTnT, as a single measurement or in series, can accurately predict patients at low risk of short-term adverse events.</p><p><strong>Conclusion: </strong>TACIT will explore the value of hsTnT measurements in isolation, or in combination with other markers of disease severity, for the identification of ED patients with AHF who are at low risk of short-term adverse events.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"85-90"},"PeriodicalIF":8.9,"publicationDate":"2017-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S130807","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35053196","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":"Long-term treatment-related morbidity in differentiated thyroid cancer: a systematic review of the literature.","authors":"William Ae Parker,&nbsp;Ovie Edafe,&nbsp;Sabapathy P Balasubramanian","doi":"10.2147/POR.S130510","DOIUrl":"https://doi.org/10.2147/POR.S130510","url":null,"abstract":"<p><strong>Background: </strong>Differentiated thyroid cancer (DTC) occurs in relatively young patients and is associated with a good prognosis and long survival. The management of this disease involves thyroidectomy, radioiodine therapy, and long-term thyroid-stimulating hormone suppression therapy (THST). The long-term effects of the treatment and the interaction between subclinical hyperthyroidism and long-term hypoparathyroidism are poorly understood. This review sought to examine the available evidence.</p><p><strong>Methods: </strong>A PubMed search was carried out using the search terms \"Thyroid Neoplasms\" AND (\"Thyroxine\" OR \"Hypocalcemia\" OR \"Thyrotropin\"). Original English language articles published in the last 30 years studying the morbidity from thyroid-stimulating hormone (TSH) suppression and hypoparathyroidism following a surgery for DTC were retrieved and reviewed by 2 authors.</p><p><strong>Results: </strong>Of the 3,000 results, 66 papers including 4,517 patients were selected for the present study. Studies reported on a range of skeletal (included in 34 studies, 1,647 patients), cardiovascular (17 studies, 957 patients), psychological (10 studies, 663 patients), and other outcomes (10 studies, 1,348 patients). Nine of 26 studies on patients who underwent THST showed a reduction in bone density, and 13 of 23 studies showed an increase in bone turnover markers. Skeletal effects were more marked in postmenopausal women. There was no evidence of increased fracture risk, and only little data were available on hypoparathyroidism. Four of five studies showed an increased left ventricular mass index on echocardiography, and one study showed a higher prevalence of atrial fibrillation (AF). There was little difference in basic physiological parameters and limited literature regarding symptoms or significant events. Six studies showed associations between long-term TSH suppression and impaired quality of life. Impaired glucose metabolism and prothrombotic states were also found in DTC patients.</p><p><strong>Conclusion: </strong>There is limited literature regarding long-term DTC treatment-related morbidity, particularly regarding the effects of long-term hypocalcemia. Most studies have focused on surrogate markers and not on clinical outcomes. A large prospective study on defined clinical outcomes would help characterize the morbidity of treatment and stimulate research on tailoring treatment strategies.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"8 ","pages":"57-67"},"PeriodicalIF":8.9,"publicationDate":"2017-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S130510","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35035352","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}