Pragmatic and Observational Research最新文献

{"title":"Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy","authors":"J. Alexander, R. Edwards, L. Manca, Roberto Grugni, Gianluca Bonfanti, B. Emir, E. Whalen, S. Watt, M. Brodsky, B. Parsons","doi":"10.2147/POR.S214412","DOIUrl":"https://doi.org/10.2147/POR.S214412","url":null,"abstract":"Purpose Variability in patient treatment responses can be a barrier to effective care. Utilization of available patient databases may improve the prediction of treatment responses. We evaluated machine learning methods to predict novel, individual patient responses to pregabalin for painful diabetic peripheral neuropathy, utilizing an agent-based modeling and simulation platform that integrates real-world observational study (OS) data and randomized clinical trial (RCT) data. Patients and methods The best supervised machine learning methods were selected (through literature review) and combined in a novel way for aligning patients with relevant subgroups that best enable prediction of pregabalin responses. Data were derived from a German OS of pregabalin (N=2642) and nine international RCTs (N=1320). Coarsened exact matching of OS and RCT patients was used and a hierarchical cluster analysis was implemented. We tested which machine learning methods would best align candidate patients with specific clusters that predict their pain scores over time. Cluster alignments would trigger assignments of cluster-specific time-series regressions with lagged variables as inputs in order to simulate “virtual” patients and generate 1000 trajectory variations for given novel patients. Results Instance-based machine learning methods (k-nearest neighbor, supervised fuzzy c-means) were selected for quantitative analyses. Each method alone correctly classified 56.7% and 39.1% of patients, respectively. An “ensemble method” (combining both methods) correctly classified 98.4% and 95.9% of patients in the training and testing datasets, respectively. Conclusion An ensemble combination of two instance-based machine learning techniques best accommodated different data types (dichotomous, categorical, continuous) and performed better than either technique alone in assigning novel patients to subgroups for predicting treatment outcomes using microsimulation. Assignment of novel patients to a cluster of similar patients has the potential to improve prediction of patient outcomes for chronic conditions in which initial treatment response can be incorporated using microsimulation. Clinical trial registries www.clinicaltrials.gov: NCT00156078, NCT00159679, NCT00143156, NCT00553475.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 1","pages":"67 - 76"},"PeriodicalIF":8.9,"publicationDate":"2019-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S214412","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48442657","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}

{"title":"Prescription patterns of analgesics, antipyretics, and non steroidal anti-inflammatory drugs for the management of fever and pain in pediatric patients: a cross-sectional, multicenter study in Latin America, Africa, and the Middle East","authors":"María Carolina Kamel Escalante, A. Abbas, A. Farah, Ernesto Rivera-Richardson, F. Burgos, Ilenia Forero, M. Murrieta-Aguttes, Mohamed El Laboudy, Ndeye Ramatoulaye Diagne-Gueye, Sergio B Barragán Padilla","doi":"10.2147/POR.S168140","DOIUrl":"https://doi.org/10.2147/POR.S168140","url":null,"abstract":"Objective To evaluate the daily practice of pediatricians, physician-perceived reasons for unsatisfactory effects of treatment, and unmet needs in the management of acute pain and/or fever. Methods This was a multinational (n=13), multicenter, non interventional, cross-sectional study conducted in Latin America, Africa, and the Middle East in children under 16 years of age with fever (defined as a central body temperature ≥38°C) and/or acute pain (defined as pain lasting ≤6 weeks). Data were collected during a single visit using a structured physician-administered questionnaire and case report forms. Results A total of 2125 patients were recruited by 178 physicians between September 2010 and September 2011. From the 2117 analyzed patients, 1856 (87.7%) had fever, 705 (33.3%) had acute pain, and 446 (21.1%) had both. Of 1843 analyzed patients with fever, 1516 (82.3%) were previously prescribed a pharmacological treatment for the management of fever concomitantly with a non pharmacological approach, while 1817/1856 patients (97.9%) were currently receiving a prescribed pharmacological treatment for fever. Paracetamol/acetaminophen was the most commonly prescribed antipyretic medication during both previous (70.8%) and current (64.1%) consultations. With regard to acute pain management, 67.2% of the patients received previous and 93.9% received current treatment for pain. The most frequently prescribed analgesic during previous consultations was paracetamol/acetaminophen (53.7%), and the current most commonly prescribed analgesics were non steroidal anti-inflammatory drugs (55.2%). Treatment patterns for patients with both fever and acute pain were similar. Overall, 53.4% of the physicians reported poor treatment compliance as a reason for the unsatisfactory effect of the pain/fever treatment, and the most common unmet need was the availability of new drugs (according to 63.5% of the physicians). Conclusions Adequate management of fever was observed; however, due to the complex etiology of pediatric pain, better evaluation and management of pain in pediatrics is necessary.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 1","pages":"41 - 51"},"PeriodicalIF":8.9,"publicationDate":"2019-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S168140","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49127551","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}

{"title":"A multicenter, open-label, noninterventional study to evaluate the impact on clinical effects, user-friendliness and patients' acceptance of AirFluSal Forspiro in the treatment of asthma under real-life conditions (ASSURE).","authors":"Vibeke Backer,&nbsp;Leif Bjermer,&nbsp;Olav Kåre Refvem,&nbsp;Andreas Søderman,&nbsp;Spencer Jones","doi":"10.2147/POR.S200654","DOIUrl":"https://doi.org/10.2147/POR.S200654","url":null,"abstract":"<p><p><b>Background:</b> The design of inhaler devices may potentially influence adherence/persistence and outcomes in asthma. <b>Objective:</b> The primary objective was to assess asthma control and any change in the quality of life in patients using an intuitive dry powder inhaler containing fluticasone propionate/salmeterol (AirFluSal^® Forspiro^®) for the treatment of asthma in everyday practice. <b>Methods:</b> ASSURE was a multicenter, noninterventional, open-label, prospective study in patients with asthma, aged ≥12 years and treated with the Forspiro device in Denmark, Sweden and Norway. Patients' opinions of their asthma control were assessed by the Asthma Control Test (ACT) questionnaire and asthma-related quality of life by the Mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and at two follow-up visits (approximately 4-8-week intervals). <b>Results:</b> Of 321 patients enrolled in the study, 299 received at least one dose of fluticasone propionate/salmeterol via the Forspiro device and 204 had evaluable data at the baseline visit and at least one later visit. Patients showed improvements in asthma control and quality of life during the study. The mean sum score of ACT increased from 18.0 (SD 4.5) at visit 1 to 19.9 (4.2) at visit 2 and 20.5 (4.3) at visit 3. Overall, 38.2% of patients improved by the minimal clinically important difference (MCID) of ≥3 points (45.6% among those with a baseline score below 23 [ie, not already well controlled]). The mean score on the miniAQLQ increased from 5.16 (SD 1.24) at visit 1 to 5.58 (SD 1.20) at visit 2 and 5.82 (SD 1.04) at visit 3. Overall, 42.6% of patients improved by the MCID of ≥0.5. <b>Conclusion:</b> This real-life study suggests that treatment with fluticasone propionate/salmeterol via the Forspiro device can improve asthma symptom control and quality of life.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 ","pages":"29-39"},"PeriodicalIF":8.9,"publicationDate":"2019-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S200654","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37348029","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":"Casual effect of methotrexate+etanercept/infliximab on survival of patients with rheumatoid arthritis.","authors":"Saeed Akhlaghi,&nbsp;Maryam Sahebari,&nbsp;Mahmoud Mahmoodi,&nbsp;Mehdi Yaseri,&nbsp;Mohammad Ali Mansournia,&nbsp;Hojjat Zeraati","doi":"10.2147/POR.S194408","DOIUrl":"https://doi.org/10.2147/POR.S194408","url":null,"abstract":"<p><p><b>Background and objectives:</b> Following the discovery of new drugs, physicians and pharmaceutical companies have become interested in examining patients' mortality and morbidity rates. In this respect, the effects of methotrexate (MTX)+etanercept/infliximab (ETA/INF) therapy on the survival of rheumatoid arthritis patients (RA) were evaluated in this study using marginal structural piecewise constant baseline hazard model. <b>Patients and methods:</b> According to the standard protocol, MTX is considered as the first-line treatment for RA patients. If there is no adequate response to MTX, biologic drugs will be added. To compare the survival rates of RA patients in MTX- and MTX+ETA/INF-treated groups, the piecewise constant baseline hazard model was fitted. Then, due to the existence of the time-dependent confounder (VAS) which was affected by previous treatment, the weight for each person-time was calculated via the inverse probability treatment weighting method. These weights were then used by marginal structural piecewise constant baseline hazard model. Finally, these models were compared. <b>Results:</b> The median (IQR) of the follow-up period in patients receiving MTX+ETN/INF and MTX was 11 (15.25) and 11 (31), respectively, and the 8-year survival rate was reported by 70% versus 68%, respectively. First, the piece-wise constant baseline hazard model was fitted. Fitting the given model showed that MTX+ETA/INF had a significant effect on patients' survival (HR=0.789, 95% CI [0.634, 0.983]). Second, marginal structural piecewise constant baseline hazard model was fitted. But, the results of this model revealed that MTX+ETA/INF did not have a significant impact on patients' survival (HR=0.968, 95% CI [0.860, 1.090]). <b>Conclusion:</b> Adjusting the pain score over time as a time-dependent confounder via marginal structural piecewise constant baseline hazard model, it has been demonstrated that MTX+ETA/INF does not have a significant effect on patients' survival rates. Therefore, a significant difference can be found between survival rates of these groups using longitudinal studies.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 ","pages":"23-28"},"PeriodicalIF":8.9,"publicationDate":"2019-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S194408","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37002910","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":"Using claims data to attribute patients with breast, lung, or colorectal cancer to prescribing oncologists.","authors":"Ezra Fishman,&nbsp;John Barron,&nbsp;Ying Liu,&nbsp;Santosh Gautam,&nbsp;Justin E Bekelman,&nbsp;Amol S Navathe,&nbsp;Michael J Fisch,&nbsp;Ann Nguyen,&nbsp;Gosia Sylwestrzak","doi":"10.2147/POR.S197252","DOIUrl":"https://doi.org/10.2147/POR.S197252","url":null,"abstract":"<p><strong>Background: </strong>Alternative payment models frequently require attribution of patients to individual physicians to assign cost and quality outcomes. Our objective was to examine the performance of three methods for attributing a patient with cancer to the likeliest physician prescriber of anticancer drugs for that patient using administrative claims data.</p><p><strong>Methods: </strong>We used the HealthCore Integrated Research Environment to identify patients who had claims for anticancer medication along with diagnosis codes for breast, lung, or colorectal lung cancer between July 2013 and September 2017. The index date was the first date with a record for anticancer medication and cancer diagnosis code. Included patients had continuous medical coverage from 6 months before index to at least 7 days after index. Patients who received anticancer drugs during the 6 months prior to index were excluded. The three methods attributed each patient to the physician with whom the patient had the most evaluation and management (E&M) visits within a 90-day window around the index date (Method 1); the most E&M visits with no time window (Method 2); or the E&M visit nearest in time to the index date (Method 3). We assessed the performance of the methods using the percentage of the study cohort successfully attributed to a physician, and the positive predictive value (PPV) relative to available physician-reported data on patient(s) they treat.</p><p><strong>Results: </strong>In total, 70,641 patients were available for attribution to physicians. Percentages of the study cohort attributed to a physician were: Method 1, 92.6%; Method 2, 96.9%; and Method 3, 96.9%. PPVs for each method were 84.4%, 80.6%, and 75.8%, respectively.</p><p><strong>Conclusion: </strong>We found that a claims-based algorithm - specifically, a plurality method with a 90-day time window - correctly attributed nearly 85% of patients to a prescribing physician. Claims data can reliably identify prescribing physicians in oncology.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 ","pages":"15-22"},"PeriodicalIF":8.9,"publicationDate":"2019-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S197252","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37180717","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":"The effect of lercanidipine or lercanidipine/enalapril combination on blood pressure in treatment-naïve patients with stage 1 or 2 systolic hypertension.","authors":"Brian Rayner","doi":"10.2147/POR.S186070","DOIUrl":"https://doi.org/10.2147/POR.S186070","url":null,"abstract":"<p><strong>Purpose: </strong>To describe the efficacy of a stratified approach on automatic office blood pressure (BP), 24-hour ambulatory BP, and BP variability (BPV) in treatment-naïve patients with systolic hypertension using lercanidipine for stage 1 and lercanidipine/enalapril for stage 2.</p><p><strong>Patients and methods: </strong>This was an open-label, prospective interventional study conducted in 22 general practices in South Africa. Treatment-naïve patients with stage 1 hypertension received lercanidipine 10 mg and patients with stage 2 received lercanidipine 10 mg/enalapril 10 mg. After 6 weeks, patients not reaching target (<140/90 mmHg) were up-titrated to lercanidipine 10 mg/enalapril 10 mg or lercanidipine 10 mg/enalapril 20 mg, respectively, for a further 6 weeks. Office BP was determined at each visit, and 24-hour ambulatory BP monitor (ABPM) at baseline and 12 weeks. The primary end point was changes in office BP, and secondary end points were changes in 24-hour ABPM and BPV.</p><p><strong>Results: </strong>Of the 198 patients, 48% had stage 1 and 52% stage 2 hypertension. The mean age was 55 years, body mass index was 29.2 kg/m², 48.5% were female, and 15.1% were diabetic. The mean (SD) office SBP and DBP at baseline, 6 weeks, and 12 weeks was 158.2 (13.8), 141.6 (11.1), and 138.7 (16.7) mmHg (<i>P</i><0.00001), and 92.2 (10.6), 84.6 (11.1), and 82 (13.3) mmHg (<i>P</i><0.00001), respectively. The mean (SD) systolic and diastolic daytime ABPM at baseline and 12 weeks was 157 (16.63) and 142 (14.41) mmHg (<i>P</i><0.0001) and 88 (12.34) and 81 (10.79) mmHg (<i>P</i><0.0001), and the nighttime ABPM was 146 (15.68) and 133 (13.94) mmHg (<i>P</i><0.0001) and 79.5 (11.64) and 72.5 (10.05) mmHg (<i>P</i><0.009), respectively. There were few adverse events.</p><p><strong>Conclusion: </strong>Lercanidipine and lercanidipine/enalapril for stage 1 or 2 hypertension highly improves office SBP and DBP, overall 24-hour BP, daytime BP, and nighttime BP, also reducing BPV with few adverse effects.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 ","pages":"9-14"},"PeriodicalIF":8.9,"publicationDate":"2019-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S186070","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36964862","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":"Low-fluoroscopy atrial fibrillation ablation with contact force and ultrasound technologies: a learning curve.","authors":"Paul C Zei,&nbsp;Tina D Hunter,&nbsp;Larry M Gache,&nbsp;Gerri O'Riordan,&nbsp;Tina Baykaner,&nbsp;Chad R Brodt","doi":"10.2147/POR.S181220","DOIUrl":"https://doi.org/10.2147/POR.S181220","url":null,"abstract":"Background Fluoroscopy exposure during catheter ablation is a health hazard to patients and operators. This study presents the results of implementing a low-fluoroscopy workflow using modern contact force (CF) technologies in paroxysmal atrial fibrillation (PAF) ablation. Methods A fluoroscopy reduction workflow was implemented and subsequent catheter ablations for PAF were evaluated. After vascular access with ultrasound guidance, a THERMOCOOL SMARTTOUCH® Catheter (ST) was advanced into the right atrium. The decapolar catheter was placed without fluoroscopy. A double-transseptal puncture was performed under intracardiac echocardiography guidance. ST and mapping catheters were advanced into the left atrium. A left atrial map was created, and pulmonary vein (PV) isolation was confirmed via entrance and exit block before and after the administration of isoproterenol or adenosine. Results Forty-three patients underwent PAF ablation with fluoroscopy reduction workflow (mean age: 66±9 years; 70% male), performed by five operators. Acute success rate (PV isolation) was 96.5% of PVs. One case of pericardial effusion, not requiring intervention, was the only acute complication. Mean procedure time was 217±42 minutes. Mean fluoroscopy time was 2.3±3.0 minutes, with 97.7% of patients having < 10 minutes and 86.0% having < 5 minutes. A significant downward trend over time was observed, suggesting a rapid learning curve for fluoroscopy reduction. Freedom from any atrial arrhythmias without reablation was 80.0% after a mean follow-up of 12±3 months. Conclusion Low fluoroscopy time is achievable with CF technologies after a short learning curve, without compromising patient safety or effectiveness.","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"10 ","pages":"1-7"},"PeriodicalIF":8.9,"publicationDate":"2019-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S181220","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36926484","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":"Acute cholecystitis - a cohort study in a real-world clinical setting (REWO study, NCT02796443).","authors":"Jennifer Blythe,&nbsp;Eva Herrmann,&nbsp;Dominik Faust,&nbsp;Stephan Falk,&nbsp;Tina Edwards-Lehr,&nbsp;Florian Stockhausen,&nbsp;Ernst Hanisch,&nbsp;Alexander Buia","doi":"10.2147/POR.S169255","DOIUrl":"https://doi.org/10.2147/POR.S169255","url":null,"abstract":"<p><strong>Background: </strong>For decades, the optimal timing of surgery for acute cholecystitis has been controversial. Recent meta-analyses and population-based studies favor early surgery. One recent large randomized trial has demonstrated that a delayed approach increases morbidity and cost compared to early surgery within 24 hours of hospital admission. Since cases of severe cholecystitis were excluded from this trial, we argue that these results do not reflect real-world clinical situations. From our point of view, these results were in contrast to the clinical experience with our patients; so, we decided to analyze critically all our patients with the null hypothesis that the patients treated with a delayed cholecystectomy after an acute cholecystitis have a similar or even better outcome than those treated with an early operative approach.</p><p><strong>Patients and methods: </strong>We retrospectively analyzed clinical data from all patients with cholecystectomies in the period between January 2006 and September 2015. A total of 1,723 patients were categorized into four groups: early (n=138): urgent surgery of patients with acute cholecystitis within the first 72 hours of the onset of symptoms; intermediate (n=297): surgery of patients with acute cholecystitis within an average of 10 days after the onset of symptoms; delayed (n=427): initial non-surgical treatment of acute cholecystitis with surgery performed within 6-12 weeks of the onset of symptoms; and elective (n=868): cholecystectomy within a symptom-free interval of choice in patients with symptomatic cholecystolithiasis without signs of acute cholecystitis.</p><p><strong>Results: </strong>In a real-world scenario, early/intermediate cholecystectomy in acute cholecystitis was associated with a significant increase in morbidity and mortality (Clavien-Dindo score) compared to a delayed approach with surgery performed 6-12 weeks after the onset of symptoms. The adjusted linear rank statistics showed a decrease in the complication score with values of 2.29 in the early group, 0.48 in the intermediate group, -0.26 in the delayed group and -2.12 in the elective group. The results translate into a continuous decrease of the complication score from early over intermediate and delayed to the elective group.</p><p><strong>Conclusion: </strong>These results demonstrate that delayed cholecystectomy can be performed safely. In cases with severe cholecystitis, early and/or intermediate approaches still have a relatively high risk of morbidity and mortality.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"9 ","pages":"69-75"},"PeriodicalIF":8.9,"publicationDate":"2018-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S169255","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36737243","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":"Postoperative swallowing disorder after thyroid and parathyroid resection.","authors":"Andreas Hillenbrand,&nbsp;Gregor Cammerer,&nbsp;Lisa Dankesreiter,&nbsp;Johannes Lemke,&nbsp;Doris Henne-Bruns","doi":"10.2147/POR.S172059","DOIUrl":"https://doi.org/10.2147/POR.S172059","url":null,"abstract":"<p><strong>Introduction: </strong>Dysphagia is frequently reported after thyroidectomy. Here, we investigated the incidence of postoperative dysphagia after uncomplicated thyroidectomy and parathyroidectomy. Further, we analyzed diagnosis and types of therapy to identify possible patients at risk.</p><p><strong>Patients and methods: </strong>A questionnaire was sent to 372 consecutive patients whose thyroid or parathyroid glands were operated on between May 2013 and October 2014 at Ulm University Hospital. Patients were questioned at least 6 months postoperatively.</p><p><strong>Results: </strong>In the evaluation, 219 questionnaires could be included. Fifty-three (21.3%) patients reported that the overall postoperative swallowing process was better or more trouble-free. In 110 (50.2%) patients, dysphagia was reported only immediately postoperative and disappeared later spontaneously. Sixteen patients (7.3%) stated that after a maximum of 3 months after surgery they suffered from dysphagia. One (0.5%) patient stated that up to 3 months postoperatively, swallowing problems had been successfully treated by logopedic therapy. In 39 (17.6%) patients, the complaints persisted for more than 3 months or still existed at the time of the interview. We found no correlation between dysphagia and patients' age or gender, the specimen volume, and patients' body mass index. The more invasive the operation was, the more patients suffered from dysphagia. Analyzing the frequency of dysphagia according to different diagnoses, we found a significant risk of postoperative dysphagia in patients with Graves' disease and carcinoma. Patients operated on for hyperparathyroidism were at significantly decreased risk of dysphagia.</p><p><strong>Conclusion: </strong>Nearly 20% of patients reported postoperative dysphagia after uncomplicated thyroidectomy and parathyroidectomy, especially after major surgical intervention. We found a significant risk of postoperative dysphagia in patients with Graves' disease and carcinoma and a decreased risk for patients operated on for hyperparathyroidism.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"9 ","pages":"63-68"},"PeriodicalIF":8.9,"publicationDate":"2018-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S172059","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36660174","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":"Attitudes and beliefs related to reporting alcohol consumption in research studies: a case from Jordan.","authors":"Farah H Alhashimi,&nbsp;Omar F Khabour,&nbsp;Karem H Alzoubi,&nbsp;Samah F Al-Shatnawi","doi":"10.2147/POR.S172613","DOIUrl":"https://doi.org/10.2147/POR.S172613","url":null,"abstract":"<p><strong>Background: </strong>Acceptability of alcohol consumption varies wildly across cultures. Several factors such as religious beliefs and social desirability might influence reporting of such behaviors to researchers during relevant investigations.</p><p><strong>Aims: </strong>This study aimed at assessing reporting of alcohol consumption during participation in research studies in Jordan, and identifying potential reasons and ethical challenges associated with reporting this behavior.</p><p><strong>Subjects and methods: </strong>A sample of 400 Jordanians was anonymously surveyed regarding alcohol consumption reporting.</p><p><strong>Results: </strong>The study showed a tendency of not reporting alcohol consumption in research (56.8%). Religious belief and trust issues regarding reporting sensitive information during participation in research were significantly the main reasons of not reporting alcohol drinking (<i>P</i><0.05), while social shame effect was limited to rural areas (<i>P</i><0.05).</p><p><strong>Conclusion: </strong>Raising Jordanians' awareness of benefits of reporting alcohol consumption is highly recommended. Improving confidence in privacy and data confidentiality among Jordanians might help in improving the level of reporting during participation in research.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"9 ","pages":"55-61"},"PeriodicalIF":8.9,"publicationDate":"2018-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S172613","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36651503","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}