Pragmatic and Observational Research最新文献

Background: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

Introduction: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

Background: 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.

Aims: 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.

Subjects and methods: A sample of 400 Jordanians was anonymously surveyed regarding alcohol consumption reporting.

Results: 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 (P<0.05), while social shame effect was limited to rural areas (P<0.05).

Conclusion: 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.

Background: The aim of the study was to explore rhinitis therapy purchases in different Australian regions for patients with and without additional respiratory disease, using both doctor's prescriptions and over-the-counter (OTC) medications.

Patients and methods: It was a historical cohort study of pharmacy-related claims that included prescription or OTC rhinitis therapy, with or without asthma/COPD therapy, from January 2013 to December 2014.

Results: Overall, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over a calendar year; the majority were single-therapy purchases for rhinitis only patients. More multiple-therapy was purchased for rhinitis and asthma/COPD patients (4.4%) than for rhinitis only patients (4.0%), with a greater proportion purchased in VIC, SA and TAS (4.7% of rhinitis only patients and 4.5% of rhinitis and asthma/COPD patients) than in other areas. Dual therapy of oral antihistamine (OAH) and intranasal corticosteroid (INS) were the most frequently purchased multiple-therapy, with higher purchasing rates for rhinitis and asthma/COPD patients (2.6%) than for rhinitis only patients (1.6%). The most frequently purchased single therapy was OAH (70.1% of rhinitis only patients and 57.3% of rhinitis and asthma/COPD patients). First-line INS therapy was more likely to be purchased for rhinitis and asthma/COPD patients (15.3% by prescription and 11.7% OTC) than for rhinitis only patients (5.0% by prescription and 9.2% OTC); however, geographical differences in the proportion of therapies purchased OTC were noted, with a lower proportion of OTC OAH and INS purchases in Queensland and the Northern Territory for patients with and without comorbid respiratory disease.

Conclusion: Purchases of first-line INS therapy are more likely for patients with comorbid respiratory disease if they have received prescriptions and information/advice from their general practitioner. The study results indicate a need for patient information/education at the point-of-sale of OTC OAHs to enable patients to assess their nasal symptoms and receive treatment support from pharmacists. Greater availability to INSs in pharmacies as well as guidance from current guidelines and instruction in correct intranasal technique may also lead to greater uptake of INSs.

Background: Observational research is essential to evaluate the real-life effectiveness of asthma treatments and can now make use of outcomes derived from electronic medical records.

Aim: The aim of this study was to investigate the utility of several database outcome measures in asthma.

Methods: This study identified cohorts of patients with active asthma from a UK primary care database - Optimum Patient Care Research Database - approximately 10% of which was prospectively supplemented with questionnaire data. The "Questionnaire cohort" included patients aged 18-60 years with valid questionnaire data and 1 year of continuous primary care data. Separate "ICS initiation" and "ICS step-up" cohorts included patients aged 5-60 years initiated on inhaled corticosteroids (ICSs), who had 1 year of continuous primary care data before, and after, this index visit. Database measures of asthma symptom control and exacerbations were identified in the Optimum Patient Care Research Database and cross-tabulated with corresponding patient-reported (questionnaire) data. Responsiveness of the database outcomes was analyzed, using McNemar's and Wilcoxon's signed rank tests, and Poisson regression was used to estimate the association between database outcomes and future risk of database exacerbations, in the ICS initiation cohort.

Results: The final study included 2,366 Questionnaire cohort patients and 51,404 ICS initiation patients. Agreement between patient-reported and database-recorded exacerbations was fair (kappa 0.35). Following the initiation of ICS, database risk domain asthma control (based on exacerbations) improved (proportion of patients with uncontrolled asthma decreased from 24.9% to 18.6%; P<0.001) and mean number of database exacerbations decreased from 0.09 to 0.08 per patient per year (P=0.001). However, another measure of asthma control which includes short-acting beta-agonist prescription as part of the definition did not show this improvement. Patients with prior exacerbations had a higher risk of future exacerbation (rate ratio [95% confidence interval], 3.23 [3.03-3.57]).

Conclusion: Asthma control and exacerbations derived from primary care databases were responsive, with the exception of short-acting beta-agonist prescriptions, and useful for risk prediction.

Purpose: To estimate the incidence of postprocedural early cardiac complications among patients undergoing transcatheter aortic valve implantation, through transapical approach (TA-TAVI), and to identify factors independently associated with the occurrence of them.

Patients and methods: A retrospective cohort study of 90 patients, who had undergone TA-TAVI in a tertiary hospital of Liverpool, UK, during a 5-year period (September 2008-October 2013), was conducted. Data on patient demographics, periprocedural characteristics and cardiac complications presented within 30-day post TA-TAVI were collected, retrospectively, using the hospital's electronic database.

Results: The overall 30-day incidence of cardiac complications was estimated at 18.9% (n=17/90). The rate of new onset of atrial fibrillation (AF), atrioventricular block requiring permanent pacemaker implantation, shockable cardiac arrest rhythm and cardiac tamponade was 11.1%, 3.3%, 2.2% and 2.2%, respectively. Bivariate analysis found that absence of preoperative AF (p=0.01), receiving of oral inotropes preprocedurally (p=0.01), intravenous inotropic support postprocedurally (p=0.01) and requirement for postprocedural tracheal intubation (p=0.001) were the main factors associated with increased probability for patient cardiac morbidity.

Conclusion: It seems that patients with absence of AF and oral inotropic support preprocedurally and those with post TA-TAVI mechanical ventilatory and intravenous inotropic support have greater probability to develop cardiac complications. This knowledge allows the early identification of high-risk patients and supports clinicians to apply both preventive and therapeutic interventions for the optimum patient management and care. In addition, administrators could allocate the health care system resources effectively.

Background: Delirium is a quite common complication in adult patients post-cardiac surgery. The purpose of our study was to identify perioperative characteristics and also focus on incidence factors that could predict delirium in the cardiac surgery intensive care unit (CICU) postoperatively.

Methods: We conducted a prospective study of 179 consecutive patients, who underwent open-heart surgical operation and were admitted to the CICU of a general tertiary hospital in Athens, Greece. The patients were screened for delirium by using the diagnostic tools of Rich-mond Agitation Sedation Scale (RASS score) and the Confusion Assessment Method - ICU (CAM-ICU). The delirium assessment was carried out on the 1st and the 2nd postoperative day, and was conducted twice every nursing shift. A short questionnaire on sociodemographics and clinical patient characteristics was used for data collection purposes.

Results: A total of 179 patients who underwent open-heart surgical operation with cardiopulmonary bypass (CPB) were enrolled in our study. The 2-day incidence of postoperative delirium in ICU was 11.2% (n=20/179). The main independent predictors of delirium on the 2nd postoperative day were neutrophil-to-lymphocyte ratio (p=0.001) and urea levels (p=0.016). Additionally, increased perioperative creatinine (p=0.006) and sodium (p=0.039) levels were significantly associated with delirium occurrence. Furthermore, elevated EuroSCORE (p=0.001), extended length of stay (LOS) in ICU (p<0.001), and extended LOS with endotracheal tube (p=0.001) were also statistically significant indicators.

Conclusion: Patients with extended LOS with endotracheal tube and prolonged stay in ICU in accordance with peaked urea, neutrophil-to-lymphocyte ratio, creatinine, and sodium levels seem to have a significantly greater probability of developing delirium in the ICU. Further research is needed in the field of postoperative cardiac patients in order to determine the causality and etiology of certain risk factors for delirium.

Objective: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment.

Methods: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included.

Outcomes and measures: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs).

Results: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA₂DS₂VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA₂DS₂VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17-1.28/1.22; 1.17-1.28), IS (1.90; 1.69-2.15/1.92; 1.69-2.19), non-specified strokes (2.04; 1.16-3.70/1.93; 1.13-3.32), TIAs (1.52; 1.29-1.79/1.44; 1.21-1.70), MIs (1.26; 1.10-1.15/1.31; 1.13-1.52), AE (1.75; 1.32-2.32/1.81; 1.36-2.34) and severe bleeding (1.92; 1.71-2.15/1.95; 1.74-2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616).

Conclusion and relevance: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients.

Rationale: DPP-4 may regulate immunological pathways implicated in asthma. Assessing whether DPP-4 inhibitor (DPP-4i) use might affect asthma control is clinically important because DPP-4i use in type 2 diabetes mellitus management (T2DM) is increasing. This study evaluated associations between DPP-4i use and asthma control.

Methods: This was a retrospective, observational, matched cohort study using administrative claims in the MarketScan^® Commercial Claims and Encounters (Commercial) and Medicare Supplemental and Coordination of Benefits (Medicare Supplemental) databases. Adult asthma patients initiating an oral DPP-4i or a non-DPP-4i between November 1, 2006 and March 31, 2014 were included. Patients were followed for asthma-related outcomes for 12 months after initiation of the antidiabetes medication. Outcomes included risk-domain asthma control (RDAC), defined as no asthma hospitalizations, no lower respiratory tract infections, and no oral corticosteroid (OCS) prescriptions; overall asthma control (RDAC criteria plus limited short-acting beta agonist use); treatment stability (RDAC criteria plus no increase of ≥50% in inhaled corticosteroid dose or addition of other asthma therapy); and severe asthma exacerbation rates (asthma-related hospitalizations, emergency room visits, or acute treatments with OCS). Comparisons were made between two matched cohorts (DPP-4i vs. non-DPP-4i initiators) using multivariable logistic regression and generalized linear modeling. Covariates included baseline demographic and clinical characteristics related to asthma and T2DM.

Results: The adjusted odds of achieving RDAC (odds ratio [OR]: 1.05; 95% CI: 0.964 to 1.147), overall asthma control (OR: 1.04; 95% CI: 0.956 to 1.135), and treatment stability (OR: 1.04; 95% CI: 0.949 to 1.115) did not differ between the DPP-4i and non-DPP-4i cohorts. A difference was not found between cohorts in severe asthma exacerbation rates during the 12 months following initiation of antidiabetes treatment (mean = 0.32 vs. 0.34 exacerbations per subject-year, respectively; p=0.064).

Conclusion: Asthma control was similar between patients initiating DPP-4i and non-DPP-4i antidiabetes medications, suggesting no association between DPP-4i use and asthma control.

Background: Although Ethiopia has shown remarkable achievements in reducing maternal mortality in the last 10 years, the prevalence of late antenatal care (ANC) initiation is still high in the country.

Objective: The primary purpose of this study was to identify the factors related to late ANC initiation among pregnant women in selected public health centers in Addis Ababa, Ethiopia.

Subjects and methods: A total of 402 pregnant women (cases=134, controls=268) were recruited using multistage sampling. The design selected for the study was unmatched case-control. EpiData version 3.02 and SPSS version 20.0 were used for data entry and statistical analysis, respectively. Binary logistic regression model was used to model the odds of late ANC initiation.

Results: The odds of attending ANC late were significantly higher for mothers with a monthly household income of $8.50 to start the ANC service (AOR=3.04; 95% CI: 1.98, 4.67).

Conclusion: Low educational level, low income of the household, unplanned pregnancy, stay for <5 years in Addis Ababa, not getting advice from health extension workers or local TV/radio and higher cost associated with initiation of the first ANC service were the main predictors of late ANC initiation. Therefore, any intervention which would need to improve early ANC initiation should focus on economic empowerment of women, and tailored health education for migrant women should be strengthened.