RESUMEN

BACKGROUND: Collection of detailed dietary data is labor intensive and expensive, harmonization of existing data sets has been proposed as an effective tool for research questions in which individual studies are underpowered. METHODS: In this paper, we describe the methodology used to retrospectively harmonize nutritional data from multiple sources, based on the individual participant data of all available studies, which collected nutritional data in Israel between 1963 and 2014. This collaboration was established in order to study the association of red and processed meat with colorectal cancer. Two types of nutritional questionnaires, the Food Frequency Questionnaires (FFQ) and the 24-h dietary recall (24HR recall), and different food composition tables, were used by the participating studies. The main exposure of interest included type of meat (total meat, red meat, and poultry) and level of processing. RESULTS: A total of 29,560 Israeli men and women were enrolled. In studies using FFQ,the weighted mean intakes of total, red, processed meat, and poultry were 95, 27, 37 and 58 gr/day and 92, 25, 10, and 66 gr/day in studies using 24HR recall, respectively.. Despite several methodological challenges, we successfully harmonized nutritional data from the different studies. CONCLUSIONS: This paper emphasizes the significance and feasibility of harmonization of previously collected nutritional data, offering an opportunity to examine associations between a range of dietary exposures and the outcome of interest, while minimizing costs and time in epidemiological studies.

Asunto(s)

RESUMEN

Multiple myeloma (MM) is an incurable hematological cancer requiring multiple lines of anti-myeloma regimens to promote disease remission and increase patient survival. The study assessed the incidence and reasons for discontinuation of first-line therapy in outpatients who started MM therapy in Belo Horizonte, Brazil from 2009 to 2020. A historical cohort study in which patients were followed from treatment initiation until discontinuation of first-line therapy. Discontinuation of first-line therapy was characterized as (i) discontinuation followed by a second-line therapy, and (ii) discontinuation that prevented patients from receiving a subsequent line of treatment. Non-parametric competing risk analysis with a 95% confidence interval estimated the cumulative incidences of discontinuation followed by a second-line therapy. The probability of discontinuation was compared according to selected variables using the Gray's test at a significance level of 5%. Approximately half of the participants (n = 260) were female and younger than 65 years. Discontinuation of first-line therapy followed by a second-line therapy accounted for 50.4% of the patients and occurred up to 30th month. The main reason for discontinuation not qualifying patients for receiving second-line therapy was to achieve a response to treatment. The maximum times for discontinuation not followed by a second-line therapy ranged from 12 to 20 months due to deaths or response to treatment. The probability of receiving second-line therapy was higher among patients initiating therapy in 2009-2014 and those not undergoing transplantation. In conclusion, discontinuation of first-line therapy followed by second-line treatment occurred as likely as the discontinuation not followed by a subsequent line.

RESUMEN

Previous studies found inconsistent associations between ambient temperature during pregnancy and the risk of preeclampsia. If such associations are causal, they may impact the future burden of preeclampsia in the context of climate change. We used a historical cohort of 129,009 pregnancies (5074 preeclampsia cases) from southern Israel that was merged with temperature assessments from a hybrid satellite-based exposure model. Distributed-lag and cause-specific hazard models were employed to study time to all preeclampsia cases, followed by stratification according to early (≤34 weeks) and late (>34 weeks) onset disease and identify critical exposure periods. We found a positive association between temperature and preeclampsia during gestation, which was stronger in the 3rd trimester. For example, during week 33, compared to the reference temperature of 22.4 °C, the cause-specific hazard ratio (HRCS) of preeclampsia was 1.01 (95% confidence interval (CI): 1.01-1.02) when exposed to 30 °C, 1.05 (95%CI: 1.03-1.08) at 35 °C, and 1.07 (95%CI: 1.04-1.10) at 37 °C. The associations existed with both early- and late-onset preeclampsia; however, the associations with the early-onset disease were somewhat stronger, limited to the first weeks of pregnancy and the third trimester, and with larger confidence intervals. The HRCS for early preeclampsia onset, when exposed to 37 °C compared to 22.4 °C during week 33, was 1.12 (95%CI: 0.96-1.30), and for late-onset preeclampsia, the HRCS was 1.09 (95%CI: 1.05-1.13). To conclude, exposure to high temperatures at the beginning and, particularly, the end of gestation is associated with an increased risk of preeclampsia in southern Israel.

Asunto(s)

RESUMEN

We evaluated the utility of the Hospital Frailty Risk Score (HFRS) as a predictor of adverse events after hospitalization in a retrospective analysis of traumatic brain injury (TBI). This historical cohort study analyzed the data of patients hospitalized with TBI between April 2014 and August 2020 who were registered in the JMDC database. We used HFRS to classify the patients into the low- (HFRS < 5), intermediate- (HFRS5-15), and high- (HFRS > 15)-frailty risk groups. Outcomes were the length of hospital stay, the number of patients with Barthel Index score ≥ 95 on, Barthel Index gain, and in-hospital death. We used logistic and linear regression analyses to estimate the association between HFRS and outcome in TBI. We included 18,065 patients with TBI (mean age: 71.8 years). Among these patients, 10,139 (56.1%) were in the low-frailty risk group, 7388 (40.9%) were in the intermediate-frailty risk group, and 538 (3.0%) were in the high-frailty risk group. The intermediate- and high-frailty risk groups were characterized by longer hospital stays than the low-frailty risk group (intermediate-frailty risk group: coefficient 1.952, 95%; confidence interval (CI): 1.117−2.786; high-frailty risk group: coefficient 5.770; 95% CI: 3.160−8.379). The intermediate- and high-frailty risk groups were negatively associated with a Barthel Index score ≥ 95 on discharge (intermediate-frailty risk group: odds ratio 0.645; 95% CI: 0.595−0.699; high-frailty risk group: odds ratio 0.221; 95% CI: 0.157−0.311) and Barthel Index gain (intermediate-frailty risk group: coefficient −4.868, 95% CI: −5.599−−3.773; high-frailty risk group: coefficient −19.596, 95% CI: −22.242−−16.714). The intermediate- and high-frailty risk groups were not associated with in-hospital deaths (intermediate-frailty risk group: odds ratio 0.901; 95% CI: 0.766−1.061; high-frailty risk group: odds ratio 0.707; 95% CI: 0.459−1.091). We found that HFRS could predict adverse outcomes during hospitalization in TBI patients.

RESUMEN

Purpose: Low total protein (TP) is associated with mortality among patients with specific diseases, but its association was uncertain among general patients. We evaluated the effects of low TP on in-hospital mortality among general inpatients. Patients and Methods: We used data from the Japan Adverse Drug Events study series. We enrolled adult inpatients (≥ 16 years) admitted to a tertiary care hospital between September 1 and November 30, 2013. We excluded patients with multiple myeloma, pregnant women, and bone marrow graft donors. Patient data were extracted from electronic medical records. All patients were stratified into those with and without malignancy and divided into the low and normal TP groups. Low TP was defined as < 6.5 g/dL. We compared the in-hospital mortality of the low and normal TP groups stratified by the presence of malignancy. Results: Among the 2235 enrolled patients (mean age, 67.8 years), the TP value was lower in 516 patients with malignancy than in 1719 patients without malignancy (6.6 g/dL vs 6.8 g/dL, P = 0.0002). Among patients without or with malignancy, 27% (462/1719) and 35% (183/516) were in the low TP group, respectively. Mortality was higher in the low TP group among patients without malignancy (23.2% vs 10.2%, P < 0.0001). Likewise, among patients with malignancy, mortality was higher in the low TP group (34.7% vs 11.3%, P = 0.0029). The adjusted hazard ratio of the low TP group was 1.75 (95% confidence interval, 1.04-2.96) in patients without malignancy and 2.45 (95% confidence interval, 1.12-5.37) in patients with malignancy, but the interaction was not significant (P = 0.23). Conclusion: Low TP values were associated with higher in-hospital mortality among general inpatients, and this association was observed among patients with and those without malignancy. Routinely measured TP should be utilized to risk stratification on admission.

RESUMEN

Hyperuricemia causes gout and has also been associated with metabolic syndrome and cardiovascular disease. Uric acid-lowering drugs (ULDs) are used to reduce uric acid levels for the treatment of hyperuricemia and gout. However, there is a lack of robust and real-world data on the history and treatment of patients with newly diagnosed hyperuricemia or gout in Japan. This retrospective, longitudinal, historical cohort study determined the characteristics of patients with hyperuricemia and/or gout, and prescription of, and adherence to, ULDs using data from the JMDC Claims Database. The primary evaluation population included 64 677 patients with newly diagnosed hyperuricemia and/or gout. Of these, only 26 501 (41.0%) had a prescription for ULDs at diagnosis. Even when ULDs were prescribed, the persistence rate of prescriptions declined over time, with a 54.4% persistence rate for ULDs at 12 months after the index diagnosis. In subgroups of patients with or without hypertension and diabetes, the rate of ULD prescription continuation was significantly higher in those with comorbidities than in those without (76.8% vs. 42.6% in those with vs. without hypertension, and 78.7% vs. 52.2% in those with vs. without diabetes). These finding suggest that therapeutic interventions to lower serum uric acid levels are under-utilized for patients with newly diagnosed hyperuricemia and/or gout in Japan.

Asunto(s)

RESUMEN

This single-center historical cohort study investigated the effectiveness and safety of extended infusion (EI) compared with short-term infusion (STI) of meropenem in neonatal sepsis. Patient electronic health records from Peking University Third Hospital (1 December 2011−1 April 2021) were screened. Neonates diagnosed with sepsis and treated with meropenem in the neonatal intensive care unit were included (256 patients) as STI (0.5 h, 129 patients) and EI (2−3 h, 127 patients) groups. Three-day clinical effectiveness and three-day microbial clearance were considered the main outcomes. Univariate and multivariate analyses were performed. Baseline characteristics were similar in both groups. EI of meropenem was associated with a significantly higher 3-day clinical effectiveness rate (0.335 (0.180, 0.623), p = 0.001) and 3-day microbial clearance (4.127 (1.235, 13.784), p = 0.021) than STI, with comparable safety. Subgroup analyses showed that neonates with very low birth weight benefited from EI in terms of 3-day clinical effectiveness rate (75.6% versus 56.6%, p = 0.007), with no significant difference in the 3-day clinical effectiveness (85.1% versus 78.3%, p = 0.325) and microbial clearance (6% versus 5%, p > 0.999) rates between 3 h and 2 h infusions. Thus, EI of meropenem may be associated with better effectiveness and comparable safety in treating neonatal sepsis than STI. Nonetheless, historically analyzed safety evaluation might be biased, and these findings need confirmation in randomized controlled trials of larger sample sizes.

RESUMEN

BACKGROUND: To identify the association between autistic tendencies and mental health among university students who study abroad. METHODS: We conducted a historical cohort study at a Japanese university, targeting students who went overseas from 2012 to 2014 as part of study abroad program. We administered questionnaires to students before and after they completed the overseas study program. These questionnaires included items about sex, age, academic degrees, department affiliations, past experience of studying abroad, type of overseas program, and schedule of departures and returns. To determine students' mental health problems, we considered cross-cultural maladaptation while studying abroad as the outcome by two reviewers. We also administered the Autism-Spectrum Quotient, Japanese version (AQ), and the General Health Questionnaire 60 Japanese version. We utilized the logistic regression model after adjusting for the General Health Questionnaire and country or region with programs to estimate odds ratios (OR) for considering outcomes. RESULTS: Of the 585 who participated in this study excluding two students for cancellations, 352 (60.2%) completed to following-up. The prevalence of mental health problems was 6.0% (21/406) and categorized when studying abroad. The mean AQ score was 19.3 (standard deviation = ±7.12). High AQ (a score of 33 and more) was prevalent among 3.7% (18/486). Students with high AQ had more mental health problems compared to those without high AQ (adjusted ORs 5.87; 95% confidence interval, 1.24-27.9, P = 0.03). CONCLUSIONS: We clarified the association between autistic tendencies and mental health for students studying abroad.

Asunto(s)

RESUMEN

The aim of this study was to examine the association between frailty risk and outcomes in older patients with pneumonia. For this purpose, the JMDC multi-center database was used, and a historical cohort study was conducted to examine the association between the Hospital Frailty Risk Score (HFRS) and oral intake prognosis and length of hospital stay in older patients hospitalized with pneumonia. Patients were classified into low-risk (HFRS < 5), intermediate-risk (HFRS = 5−15), and high-risk (HFRS > 15) groups based on their HFRS scores, and outcomes were defined as the number of days from admission to the start of oral intake and length of hospital stay. A total of 98,420 patients with pneumonia (mean age 82.2 ± 7.2) were finally included. Of these patients, 72,207 (73.4%) were in the low-risk group, 23,136 (23.5%) were in the intermediate-risk group, and 3077 (3.1%) were in the high-risk group. The intermediate- and high-risk groups had a higher number of days to the start of oral intake than the low-risk group (intermediate-risk group: coefficient 0.705, 95% confidence interval [CI] 0.642−0.769; high-risk group: coefficient 0.889, 95% CI 0.740−1.038). In addition, the intermediate- and high-risk groups also had longer hospital stays than the low-risk group (intermediate-risk group: coefficient 5.743, 95% CI 5.305−6.180; high-risk group: coefficient 7.738, 95% CI 6.709−8.766). Overall, we found that HFRS is associated with delayed initiation of oral intake and prolonged hospital stay in older patients with pneumonia. Therefore, evaluation based on HFRS could be helpful in making clinical decisions regarding the selection of feeding strategies and when to discharge older patients with pneumonia.

RESUMEN

CONTEXT: It is generally acknowledged that osteopathic physicians take a holistic approach to patient care. This style may help prevent the progression of painful musculoskeletal conditions, particularly if combined with osteopathic manipulative treatment (OMT). OBJECTIVES: The study aimed to determine if osteopathic medical care lowers the risk of progression from localized chronic low back pain to widespread pain and lessens the impact of pain on health-related quality of life. METHODS: A historical cohort study was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION Pain Research Registry) using data acquired from April 2016 through March 2021. Registry participants aged 21-79 years with chronic low back pain at the baseline encounter were potentially eligible for inclusion if they had a treating physician, completed all four quarterly follow-up encounters, and did not report physician crossover at the final 12-month encounter. Eligible participants were classified according to the type of physician provider at baseline and thereby into osteopathic or allopathic medical care groups. Participants were also classified according to prior use of OMT at the final encounter. Widespread pain was measured at baseline and each quarterly encounter to determine the period prevalence rate of widespread pain and its severity over 12 months using the Minimum Dataset for Chronic Low Back Pain recommended by the National Institutes of Health. Participants who reported "not being bothered at all" by widespread pain during each encounter were classified as not having widespread pain, whereas those who were bothered "a little" or "a lot" at any quarterly encounter were classified as having widespread pain. The severity of widespread pain was measured by summing participant responses at each encounter. The Patient-Reported Outcomes Measurement Information System was used at each encounter to measure health-related quality-of-life (HRQOL) scores for physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles and activities, and pain interference with activities. RESULTS: A total of 462 participants were studied, including 101 (21.9%) in the osteopathic medical care group and 73 (15.8%) who used OMT. The mean age of participants at baseline was 52.7 ± 13.2 years (range, 22-79 years) and 336 (72.7%) were female. A lower period prevalence rate of widespread pain was observed in the osteopathic medical care group (OR, 0.47; 95% CI, 0.27-0.81; p=0.006) and in the OMT group (OR, 0.40; 95% CI, 0.21-0.75; p=0.004), although the latter finding did not persist after adjustment for potential confounders. The osteopathic medical care and OMT groups both reported lower widespread pain severity. The osteopathic medical care group also reported better age- and sex-adjusted outcomes for each of the seven HRQOL dimensions throughout the study. The OMT group reported better outcomes in five of the HRQOL dimensions. CONCLUSIONS: This study supports the view that osteopathic physicians practice a holistic approach to medical care that manifests itself through a lower risk of progression from chronic low back pain to widespread pain, lower widespread pain severity, and lesser deficits in HRQOL. Similar findings were generally associated with OMT use.

Asunto(s)

RESUMEN

BACKGROUND: Among former Olympic-level athletes, engagement in different sport disciplines has been associated with mortality risk in subsequent years. However, limited evidence is available on whether engagement in different sport disciplines at a young age is associated with locomotive syndrome (LS) risk later in life. This study examined the relationship between engagement in different sport disciplines during university years and LS risk in older age among former university athletes. METHODS: Participants were 274 middle-aged and 294 older men alumni who graduated from a school of physical education in Japan. LS risk was defined as answering "yes" to any of the Loco-check questions. Data on university sports club membership were collected using questionnaires. University clubs were classified into three groups of cardiovascular intensity (low, moderate, high), following the classification system of sport disciplines by the American College of Cardiology. This classification considers the static and dynamic components of an activity, which correspond to the estimated percent of maximal voluntary contraction reached and maximal oxygen uptake achieved, respectively. University clubs were grouped based on the risk of bodily collision (no, yes) and extent of physical contact (low, moderate, high). Relationships between engagement in different sport disciplines and LS risk were analyzed using Cox proportional hazards models, and adjusted for age, height, weight, joint disease, habitual exercise, and smoking and drinking status. RESULTS: Adjusted hazard ratios and 95% confidence intervals associated with the low, moderate, and high cardiovascular intensity sports were 1.00 (reference), 0.48 (0.22-1.06, P = 0.070), and 0.44 (0.20-0.97, P = 0.042) in older men, respectively; however, there was no significant association between these parameters among middle-aged men. Engagement in sports associated with physical contact and collision did not affect LS risk in either group. CONCLUSIONS: Engagement in sports associated with high cardiovascular intensity during university years may reduce the risk of LS in later life. Encouraging young people to participate in such activities might help reduce LS prevalence among older populations.

Asunto(s)

RESUMEN

BACKGROUND: Physical fitness and motor ability are associated with the incidence of locomotive syndrome (LS) in older adults. The relationships between physical fitness and motor ability at a young age to LS risk in later life remain unclear. This study examined the association between physical fitness and motor ability among university students and their risk of LS in middle and old age. METHODS: The participants were 231 male alumni aged 48-65 years from the Department of Physical Education of a university in Japan. Physical fitness and motor ability test results during their fourth year at the university were used. Physical fitness tests included the side-step test, vertical jump test, back muscle, grip strength, trunk lift, standing trunk flexion, and step-test. Motor ability was tested using the 50-m and 1500-m run, running long jump, hand-ball throw, and pull-up test. LS risk was assessed using a seven-question standardized self-administered Loco-check questionnaire. Participants were divided into three groups (low, medium, and high) based on physical fitness and motor ability test results at young age, and LS risk was assessed at an older age across the three groups using Cox proportional hazards models. RESULTS: From the 2017 follow-up survey, the median follow-up period was 37 years (interquartile range, 33-41), and LS risk was suspected for 31 (13.4%) participants. Better performance on the side-step test was associated with the reduced risk of LS (hazard ratio 0.32; 95% confidence interval, 0.101-0.983, P = 0.047). CONCLUSIONS: Good agility (side-step test) at a young age may reduce the future risk of LS among middle-aged and older men.

Asunto(s)

RESUMEN

OBJECTIVE: To examine whether receiving a fecal occult blood test after a negative sigmoidoscopy reduced mortality from colorectal cancer. METHODS: We used a nested case-control design with incidence-density matching in historical cohorts of 1,877,740 50-90-year-old persons during 2006-2012, in an integrated health-system setting. We selected 1758 average risk patients who died from colorectal cancer and 3503 matched colorectal cancer-free persons. Colorectal cancer-specific death was ascertained from cancer and mortality registries. Screening histories were determined from electronic and chart-audit clinical data in the 5- to 10-year period prior to the reference date. We evaluated receipt of subsequent fecal occult blood test within five years of the reference date among patients with negative sigmoidoscopy two to six years before the reference date. RESULTS: Of the 5261 patients, 831 patients (204 colorectal cancer deaths/627 controls) had either negative sigmoidoscopy only (n = 592) or negative sigmoidoscopy with subsequent screening fecal occult blood test (n = 239). Fifty-six (27.5%) of the 204 patients dying of colorectal cancer and 183 (29.2%) of the 627 colorectal cancer-free patients received fecal occult blood test following a negative sigmoidoscopy. Conditional regressions found no significant association between fecal occult blood test receipt and colorectal cancer death risk, overall (adjusted odds ratio = 0.93, confidence interval: 0.65-1.33), or for right (odds ratio = 1.02, confidence interval: 0.65-1.60) or left-colon/rectum (odds ratio = 0.77, confidence interval: 0.39-1.52) cancers. Similar results were obtained in sensitivity analyses with alternative exposure ascertainment windows or timing of fecal occult blood test. CONCLUSIONS: Our results suggest that receipt of at least one fecal occult blood test during the several years after a negative sigmoidoscopy did not substantially reduce mortality from colorectal cancer.

Asunto(s)

RESUMEN

BACKGROUND@#Among former Olympic-level athletes, engagement in different sport disciplines has been associated with mortality risk in subsequent years. However, limited evidence is available on whether engagement in different sport disciplines at a young age is associated with locomotive syndrome (LS) risk later in life. This study examined the relationship between engagement in different sport disciplines during university years and LS risk in older age among former university athletes.@*METHODS@#Participants were 274 middle-aged and 294 older men alumni who graduated from a school of physical education in Japan. LS risk was defined as answering "yes" to any of the Loco-check questions. Data on university sports club membership were collected using questionnaires. University clubs were classified into three groups of cardiovascular intensity (low, moderate, high), following the classification system of sport disciplines by the American College of Cardiology. This classification considers the static and dynamic components of an activity, which correspond to the estimated percent of maximal voluntary contraction reached and maximal oxygen uptake achieved, respectively. University clubs were grouped based on the risk of bodily collision (no, yes) and extent of physical contact (low, moderate, high). Relationships between engagement in different sport disciplines and LS risk were analyzed using Cox proportional hazards models, and adjusted for age, height, weight, joint disease, habitual exercise, and smoking and drinking status.@*RESULTS@#Adjusted hazard ratios and 95% confidence intervals associated with the low, moderate, and high cardiovascular intensity sports were 1.00 (reference), 0.48 (0.22-1.06, P = 0.070), and 0.44 (0.20-0.97, P = 0.042) in older men, respectively; however, there was no significant association between these parameters among middle-aged men. Engagement in sports associated with physical contact and collision did not affect LS risk in either group.@*CONCLUSIONS@#Engagement in sports associated with high cardiovascular intensity during university years may reduce the risk of LS in later life. Encouraging young people to participate in such activities might help reduce LS prevalence among older populations.

Asunto(s)

RESUMEN

Obstructive sleep apnea syndrome is prevalent in children with syndromic craniosynostoses. Here we assessed the effects of fronto-facial monobloc advancement with internal distraction on obstructive sleep apnea in syndromic craniosynostoses. All patients managed for syndromic craniosynostosis over a period of 14 years were assessed based on apnea-hyponea index (AHI) before and after fronto-facial surgery. AHI values were analyzed using multivariate models with focuses on (1) absolute decrease in AHI values after fronto-facial surgery and (2) AHI normalization (AHI < 5) after fronto-facial surgery. One hundred and nine patients were included with 407 polysomnographic studies. Higher pre-operative AHI (p < 0.001) and pre-operative vault expansion (p = 0.008) were associated with more AHI decrease. Early airways surgery (p = 0.002) and fronto-facial surgery at older ages (p < 0.001) were associated with more AHI normalization. Our results indicate that fronto-facial surgery is specifically efficient in reducing severe (AHI > 20) obstructive sleep apnea in syndromic craniosynostoses. Early airways surgery, early vault expansion and fronto-facial surgery at older ages are recommended for better respiratory results. We provide support for a protocol involving (1) early posterior vault expansion and airways surgery and (2) fronto-facial advancement performed as late as possible (>2.5 years).

Asunto(s)

RESUMEN

OBJECTIVE: Recent trials for temporal lobe epilepsy (TLE) highlight the challenges of investigating surgical outcomes using randomized controlled trials (RCTs). Although several reviews have examined seizure-freedom outcomes from existing data, there is a need for an overall seizure-freedom rate estimated from level I data as investigators consider other methods besides RCTs to study outcomes related to new surgical interventions. METHODS: The authors performed a systematic review and meta-analysis of the 3 RCTs of TLE in adults and report an overall surgical seizure-freedom rate (Engel class I) composed of level I data. An overall seizure-freedom rate was also collected from level II data (prospective cohort studies) for validation. Eligible studies were identified by filtering a published Cochrane meta-analysis of epilepsy surgery for RCTs and prospective studies, and supplemented by searching indexed terms in MEDLINE (January 1, 2012-April 1, 2018). Retrospective studies were excluded to minimize heterogeneity in patient selection and reporting bias. Data extraction was independently reverified and pooled using a fixed-effects model. The primary outcome was overall seizure freedom following surgery. The historical benchmark was applied in a noninferiority study design to compare its power to a single-study cohort. RESULTS: The overall rate of seizure freedom from level I data was 72.4% (55/76 patients, 3 RCTs), which was nearly identical to the overall seizure-freedom rate of 71.7% (1325/1849 patients, 18 studies) from prospective cohorts (z = 0.134, p = 0.89; z-test). Seizure-freedom rates from level I and II studies were consistent over the years of publication (R2 < 0.01, p = 0.73). Surgery resulted in markedly improved seizure-free outcomes compared to medical management (RR 10.82, 95% CI 3.93-29.84, p < 0.01; 2 RCTs). Noninferiority study designs in which the historical benchmark was used had significantly higher power at all difference margins compared to using a single cohort alone (p < 0.001, Bonferroni's multiple comparison test). CONCLUSIONS: The overall rate of seizure freedom for temporal lobe surgery is approximately 70% for medically refractory epilepsy. The small sample size of the RCT cohort underscores the need to move beyond standard RCTs for epilepsy surgery. This historical seizure-freedom rate may serve as a useful benchmark to guide future study designs for new surgical treatments for refractory TLE.

RESUMEN

OBJECTIVE: Deep brain stimulation (DBS) is an effective treatment for motor symptoms of Parkinson's disease; however, there is conflicting literature about the effect of DBS on cognitive function. The authors conducted a historical cohort study involving patients with Parkinson's disease who underwent DBS of the globus pallidus pars interna (GPi; N=12) or subthalamic nucleus (STN; N=17). METHODS: The authors investigated differences in four neuropsychological test scores at 6 months post-DBS (follow-up) as compared with baseline (i.e., Boston Naming Test, WAIS Verbal Comprehension Index [WAIS-VCI], Working Memory Index [WAIS-WMI], and Processing Speed Index [WAIS-PSI]). RESULTS: GPi DBS patients showed no difference between baseline and follow-up on any neuropsychological test. STN DBS patients had lower scores indicating decreased performance at follow-up as compared with baseline on WAIS-PSI (mean [SD], 91.47 [10.42] versus 81.65 [12.03]; p=0.03). There was a significant (p=0.008) difference between the change in baseline to follow-up scores on the WAIS-VCI for the STN DBS and GPi DBS groups (i.e., STN DBS patients scored lower at the 6-month follow-up compared with baseline, whereas GPi DBS patients scored higher). CONCLUSIONS: GPi may be a preferred target for DBS in patients with Parkinson's disease when considering cognitive outcomes.

Asunto(s)

RESUMEN

A historical cohort analysis of the Japan medical data center (JMDC) claims databases was performed to compare the incidence rates of bleeding events with warfarin (WF) versus direct oral anticoagulant (DOAC) treatment in patients with non-valvular atrial fibrillation. The aim of this study is to clarify the risk factors for bleeding events in younger patients newly treated with WF or DOAC in clinical practice setting. Patients who newly initiated WF or DOAC treatment from April 2012 to March 2015 were selected from the JMDC claims database. A 1:1 propensity score matching analysis was used for new users of WF or DOAC. Kaplan-Meier curves were generated to depict the time to bleeding event (total bleeding events, gastrointestinal hemorrhage, and intracranial hemorrhage) during the follow-up period. Cox proportional regression models were used to estimate the hazard ratios for total bleeding events caused by oral anticoagulants. Overall, 2,046 patients (503 WF and 1,543 DOAC) were included. After applying propensity score matching, Kaplan-Meier analysis of the WF and DOAC groups displayed comparable incidences of total bleeding events, gastrointestinal hemorrhage, and intracranial hemorrhage. Cox proportional hazards modeling showed that the use of WF was not associated with total bleeding events compared with DOAC (hazard ratio: 1.21, 95% confidence interval: 0.93-1.54, p = 0.15). This historical cohort study using a claims database indicates that the bleeding risk of DOAC was comparable to that of WF in Japanese younger population.

Asunto(s)

RESUMEN

OBJECTIVE: Firefighters are exposed to numerous respiratory hazards, but large studies on the risk of pulmonary disease are scarce. The objective of this study was to examine incidence of asthma and chronic obstructive pulmonary disease (COPD) in a nationwide cohort of Danish firefighters. METHODS: We used individual historical employment records on 11 968 Danish male firefighters primarily supplied by trade unions and fire agencies. Furthermore, we used the Supplementary Pension Fund Register to form an occupational reference group consisting of military employees. Information on respiratory incidence was retrieved from the nationwide Danish National Patient Registry. Age and calendar time standardised incidence ratio (SIR) and Poisson regression analyses (incidence rate ratio) were used for estimation of risks, including 95% CIs. RESULTS: Compared with military employees, the overall age and calendar-time adjusted risk for asthma was significantly increased among full-time firefighters (SIR=1.58, 95% CI 1.32 to 1.88), but not among part-time/volunteer firefighters. Full-time firefighters' risk for asthma did not vary by duration of employment. No consistent evidence of an increased risk for chronic obstructive pulmonary disease was detected. CONCLUSION: Danish firefighters have an increased risk of asthma, but the causes, whether occupational or not, remain to be established.

Asunto(s)

RESUMEN

OBJECTIVES: Firefighters are exposed to multiple cardiovascular hazards, but few epidemiological studies have addressed their cardiovascular morbidity. The objective of this study was therefore to examine the incidence of cardiovascular diseases (CVD) in Danish firefighters. METHODS: We used individual historical employment records on 11.691 male Danish firefighters supplied by trade unions and fire agencies. The Supplementary Pension Fund Register was used to establish two occupational reference groups (a random sample from the male employed population and military employees). Information on CVD incidence was retrieved from the nationwide Danish National Patient Registry. SIRs and Poisson regression analyses (incidence rate ratio) were used for estimation of risks, including 95% CIs. RESULTS: In comparison with the population sample, the age-adjusted and calendar time-adjusted SIR for all CVDs combined was increased in firefighters (SIR=1.10, 95% CI 1.05 to 1.15). The risk was also elevated for the most frequent outcomes, including angina pectoris (SIR=1.16, 95% CI 1.08 to 1.24), acute myocardial infarction (SIR=1.16, 95% CI 1.06 to 1.26), chronic ischaemic heart disease (SIR=1.15, 95% CI 1.06 to 1.24) and atrial fibrillation/flutter (SIR=1.25, 95% CI 1.14 to 1.36). This analysis showed the most elevated SIRs for CVD in full-time firefighters compared with part-time/volunteer firefighters. Both types of firefighters employed <15 years had an increased risk of CVD. Similar risk patterns appeared in comparisons with the military. Internal analysis supported external findings. CONCLUSION: The risk of overall CVD, including the most frequent subtypes was modestly increased in Danish firefighters and was most elevated in full-time firefighters compared with other male employees.

Asunto(s)