Pragmatic and Observational Research最新文献

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.

Chronic neuro-musculoskeletal pain is an important complication of open-heart surgery (OHS). To better understand the development and natural course of neuro-musculoskeletal pain in the immediate post-OHS period, this prospective longitudinal study assessed the prevalence and degree of pain and shoulder disability, and areas of pain pre- and post-OHS. Usual medical, nursing, and physiotherapy care was provided including early extubation, education, walking, sitting out of bed, and upper, lower limb, and trunk exercises from day 1 post-operation. Of 114 elective patients who provided consent, 98 subjects were surveyed preoperatively, and at week 6 and week 12 post-OHS. Open and closed questions encompassed numerical rating of pain scales for various body areas summed as a total pain score (TPS), the shoulder disability score (SDS), exercise compliance, and sternal clicking. Usual care comprised mobility exercises, walking program, and cardiac rehabilitation referral. Survey return rates were 100%, 88%, and 82%, respectively. Of the 76 (78%) subjects with complete data sets, 68% subjects reported a history of previous neuro-musculoskeletal injuries/conditions preoperatively while prevalence for neuro-musculoskeletal pain was 64%, 88%, and 67% and 38%, 63%, and 42% for shoulder disability, at the three assessments. In all, 11% subjects reported sternal clicking at week 6 and 7% at week 12. Pain commonly occurred in the lower back and neck preoperatively, and in front of the chest, neck, rib cage, upper back, and left shoulder at week 6. Rib cage pain alone remained significantly greater than preoperative levels by week 12 post-OHS. Preoperative SDS was positively correlated with post-OHS length of stay; women had higher SDSs than men at week 6 and week 12 and week 12 SDS was negatively correlated with height. Surgical risk score was negatively correlated with change in SDS and TPS from pre-operation to week 12. In conclusion, neuro-musculoskeletal pain and shoulder disability were common preoperatively and while prevalence increased at week 6 post-OHS, overall preoperative levels were restored by week 12.

Purpose: Walking may improve health in obese patients with multimorbidity. We aimed to identify predictors associated with achieving <5000 steps per day after 4 months.

Patients and methods: We conducted a cohort study of 125 adult patients with a body mass index >25 kg/m² and ≥7 comorbidities. We evaluated potential predictors for <5000 steps per day using logistic regression and adjusting for age >65 years and sex.

Results: The mean (range) age was 63.6 (20.3-89.8) years. Daily step counts <5000 at baseline showed the highest risk of <5000 daily steps at 4 months (odds ratio [OR] 31.82, 95% confidence interval [CI]: 12.14-95.50). Other significant characteristics were physical quality of life (OR 6.21, 95% CI: 2.32-18.54), gait speed <1 m/s (OR 2.57, 95% CI: 1.18-5.71), age ≥65 years (OR 2.21, 95% CI: 1.05-4.77), waist circumference ≥102 cm (OR 2.48, 95% CI: 1.05-6.06), and body mass index ≥30 kg/m² (OR 2.69, 95% CI: 1.20-6.26).

Conclusion: New models to increase walking may be required for higher-risk patients.

Primary care exercise referral schemes (ERSs) are a potentially useful setting to promote physical activity (PA). It is not established, however, whether interventions to increase PA, such as ERSs, have differing health outcomes according to the participants' body mass index (BMI). This paper summarizes evidence for the impact of primary care ERSs on the health of people with obesity and reports findings of a reanalysis of the EMPOWER study, providing the first data to report differential outcomes of ERSs by BMI category. Our literature review revealed a paucity of published data. A 2011 Health Technology Assessment review and 2015 update were identified, but normal-weight participants were neither excluded nor were results stratified by weight in the included studies. A study of the effect of exercise referral in overweight women reported a significantly greater increase in PA levels in the ERS group than the control group at 3 months. Reanalysis of the EMPOWER study data showed a significant improvement in PA at 3 months in both obese and overweight/normal BMI groups, with the effect size attenuated to 6 months. There was no significant difference from baseline to 6 months in blood pressure for either BMI category. At 6 months, there was a significant decrease in weight from baseline for the obese category. Comparison of crude mean differences between BMI groups revealed a significant mean difference in PA at 3 months favoring the overweight/normal BMI group, but not at 6 months. There were no further significant differences in unadjusted or adjusted mean differences for other outcomes at follow-up. We report some evidence of a differential impact of ERS on PA by BMI category. However, the effect of ERSs in primary care for patients with obesity remains unclear due to the small number of published studies that have reported outcomes by BMI category. Further research is needed.

Purpose: To investigate the effect of body mass index (BMI) values on 1- and 2-year mortality rates in patients with chronic heart failure (HF).

Patients and methods: We conducted a retrospective cohort study of 112 patients with confirmed HF who visited the HF outpatient unit of a tertiary hospital of Athens, Greece, during a 5-month period (December 2012 - April 2013). These patients were assigned to four groups based on their BMI category. Data collection was carried out through a review of the medical patient records and the filling in of a structured questionnaire, including information on the demographic and clinical patient variables. Additionally, 1- and 2-year patient mortality was recorded. The statistical significance was two-tailed, and p-values of less than 0.05 were considered significant. The statistical analysis was performed with Mann-Whitney U test, χ² test, and Student's t-test using the SPSS software (IBM SPSS 21.0 for Windows).

Results: Obese patients had significantly lower 1-year (13% vs 34.6%, p=0.039) and 2-year (4% vs 21.4%, p=0.022) mortality rates compared with those with normal BMI values. Additionally, we found clinically and not statistically significant lower mortality in overweight and obese patients, when compared with normal BMI and overweight patients, respectively.

Conclusion: Obesity paradox seems to be present in our study, translating to significantly lower long-term mortality rates of obese patients compared to those with normal BMI. The significantly higher left ventricular ejection fraction and hematocrit levels among obese HF patients could justify our study findings. Further research is needed due to the inherent weaknesses of BMI and the other study limitations.

The Salford Lung Study (SLS) of patients with asthma and chronic obstructive pulmonary disease (COPD) is a practical, community-based, randomized, open-label pragmatic study on the efficacy and safety of the once-daily dry powder inhaler that combines the inhaled corticosteroid fluticasone furoate (FF) with the long-acting beta₂ agonist vilanterol (VI). The asthma component of the SLS is not yet reported but the COPD component, done over a 12-month period, found a statistically significant 8.4% reduction in COPD exacerbations when compared to usual care. No differences in adverse events, including serious adverse events and pneumonia, were noted. The importance of real-world findings, such as those found in the SLS COPD trial with inhaled FF/VI, is discussed in comparison to classical randomized controlled trials (RCTs) with inhaled FF/VI in COPD patients. The real-world, community-based pragmatic RCT like the SLS provides additional generalizable data with direct clinical applicability and potential usefulness in the development of practice guidelines. The results from the SLS, along with those of large and small RCTs, are supportive of the use of once-daily FF/VI in COPD maintenance therapy.

Background: Many methods are used to detect urethral Neisseria gonorrhea (NG) infection among asymptomatic men who have sex with men (MSM). The objective of this study was to define the performance of conventional culture compared to real-time polymerase chain reaction (PCR) for diagnosis of asymptomatic urethral gonorrhea among MSM.

Methods: In this cross-sectional study, 147 clinical specimens for NG testing from asymptomatic participants were evaluated. MSM >18 years old who consented to undergo urethral swab and collection of urine samples from two clinics (one was the sexually transmitted diseases (STDs) mobile clinic and the second was the antiretroviral clinic) located in Khon Kaen, Thailand, were recruited. For conventional culture, 147 swab specimens from urethra were analyzed. For real-time PCR, the same samples and collected urine (147 urethral swab and 62 urine) were evaluated.

Results: Participants were predominately older aged (mean age: 28.79 years, range: 18-54), asymptomatic (99.3%), and engaged in sex with multiple partners (63% had at least two partners and 36% had at least three partners during the previous 3 months). Twenty-five MSM (17%) had history of STD, mainly human immunodeficiency virus infection. Of the 147 specimens, 42 were positive for NG detected by real-time PCR (prevalence: 28.6%, 95% confidence interval [CI]: 24.8%-32.4%), while none of the 147 MSM were positive for NG detected by conventional culture (prevalence: 0.0%, 95% CI: 0.0%-7.3%). These findings indicated that conventional culture had low sensitivity but high specificity (0.0% and 100%, respectively). We could not demonstrate that many of the factors that were identified in other studies were associated to increased (or decreased) risk of urethral gonococcal infection in our population.

Conclusion: In asymptomatic MSM, nucleic acid amplification tests are more appropriate for screening of urethral NG infection than conventional culture. However, the culture method is necessary for monitoring emerging antimicrobial resistance and to inform gonorrhea treatment guidelines.

Purpose: To explore patterns in the purchase of prescription and over-the-counter (OTC) oral antihistamines (OAHs) and intranasal corticosteroids (INCSs) by patients, from pharmacies in different geographical regions of Australia.

Patients and methods: Retrospective observational study using a database containing anonymous pharmacy transaction data from 20.0% of the pharmacies in Australia that link doctor prescriptions and OTC information. Pharmacy purchases of at least one prescription or OTC rhinitis treatment during 2013 and 2014 were assessed.

Results: In total, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over 12 months. Of treatments purchased, 75.9% were OAHs and 16.6% were INCSs. OTC purchases of both treatments exceeded purchases through prescription. OTC OAHs purchasing patterns were seasonal and almost identical in the Australian Capital Territory, Victoria, Western Australia, South Australia, and New South Wales, and similar seasonal patterns for OTC INCSs were noted in most regions except for South Australia and Tasmania. Prescription purchasing patterns of both OAHs and INCSs remained unchanged throughout the year in most regions.

Conclusion: This large-scale retrospective observational study identified seasonal purchasing patterns of OTC and prescription OAHs and INCSs in a real-world setting. It highlighted that seasonality only affects OTC purchasing patterns of OAHs and INCSs across Australia and that practitioner prescribing remains unchanged, suggesting that it is only for persistent disease.