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Large prospective cohort studies are critical for identifying etiologic factors for disease, but they require substantial long-term research investment. Such studies can be conducted as multisite consortia of academic medical cent...
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Large prospective cohort studies are critical for identifying etiologic factors for disease, but they require substantial long-term research investment. Such studies can be conducted as multisite consortia of academic medical centers, combinations of smaller ongoing studies, or a single large site such as a dominant regional health-care provider. Still another strategy relies upon centralized conduct of most or all aspects, recruiting through multiple temporary assessment centers. This is the approach used by a large-scale national resource in the United Kingdom known as the "UK Biobank," which completed recruitment/examination of 503,000 participants between 2007 and 2010 within budget and ahead of schedule. A key lesson from UK Biobank and similar studies is that large studies are not simply small studies made large but, rather, require fundamentally different approaches in which "process" expertise is as important as scientific rigor. Embedding recruitment in a structure that facilitates outcome determination, utilizing comprehensive and flexible information technology, automating biospecimen processing, ensuring broad consent, and establishing essentially autonomous leadership with appropriate oversight are all critical to success. Whether and how these approaches may be transportable to the United States remain to be explored, but their success in studies such as UK Biobank makes a compelling case for such explorations to begin.
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Background: Moderate to vigorous physical activity (MVPA) can help to prevent depression, but identification of the most important psycho-biological pathways involved is unclear. The improvement of cardio-respiratory fitness (CRF)...
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Background: Moderate to vigorous physical activity (MVPA) can help to prevent depression, but identification of the most important psycho-biological pathways involved is unclear. The improvement of cardio-respiratory fitness (CRF) in response to MVPA can vary markedly, we therefore examined the association between CRF and the incidence of depressive symptoms. Methods: We used data from The Maastricht Study, a large population-based prospective-cohort study. CRF was estimated at baseline from a graded submaximal exercise protocol and MVPA was measured with accelerometry. Depressive symptoms were assessed using the validated Dutch version of the 9-item Patient Health Questionnaire, both at baseline and during annual follow-up over five years. Cox proportional hazards models were used. Results: A total of 1,730 individuals without depressive symptoms at baseline were included in the analysis. During the 5-year follow-up, n = 166 (9.6%) of individuals developed depressive symptoms. Compared to individuals with a low CRF, those with a moderate-to-high CRF had a significantly lower risk of developing depressive symptoms, independent of MVPA (medium CRF: HR = 0.49 (95%CI = 0.33-0.72); high CRF: HR = 0.48 (95% CI = 0.30-0.75). These associations were adjusted for age, sex, level of education, diabetes status, smoking status, alcohol use, energy intake, waist circumferences and antidepressant medications. Limitations: PHQ-9 is a validated screening instrument, but it is not a diagnostic tool of depression. Conclusions: Higher CRF was strongly associated with a lower risk of incident depressive symptoms over 5-year follow-up, independent of the level of MVPA at baseline, suggesting that interventions aimed at improving CRF could reduce the risk of depression.
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Background: Moderate to vigorous physical activity (MVPA) can help to prevent depression, but identification of the most important psycho-biological pathways involved is unclear. The improvement of cardio-respiratory fitness (CRF)...
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Background: Moderate to vigorous physical activity (MVPA) can help to prevent depression, but identification of the most important psycho-biological pathways involved is unclear. The improvement of cardio-respiratory fitness (CRF) in response to MVPA can vary markedly, we therefore examined the association between CRF and the incidence of depressive symptoms. Methods: We used data from The Maastricht Study, a large population-based prospective-cohort study. CRF was estimated at baseline from a graded submaximal exercise protocol and MVPA was measured with accelerometry. Depressive symptoms were assessed using the validated Dutch version of the 9-item Patient Health Questionnaire, both at baseline and during annual follow-up over five years. Cox proportional hazards models were used. Results: A total of 1,730 individuals without depressive symptoms at baseline were included in the analysis. During the 5-year follow-up, n = 166 (9.6%) of individuals developed depressive symptoms. Compared to individuals with a low CRF, those with a moderate-to-high CRF had a significantly lower risk of developing depressive symptoms, independent of MVPA (medium CRF: HR = 0.49 (95%CI = 0.33-0.72); high CRF: HR = 0.48 (95% CI = 0.30-0.75). These associations were adjusted for age, sex, level of education, diabetes status, smoking status, alcohol use, energy intake, waist circumferences and antidepressant medications. Limitations: PHQ-9 is a validated screening instrument, but it is not a diagnostic tool of depression. Conclusions: Higher CRF was strongly associated with a lower risk of incident depressive symptoms over 5-year follow-up, independent of the level of MVPA at baseline, suggesting that interventions aimed at improving CRF could reduce the risk of depression.
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Introduction-Factors predictive for death from snake envenomation vary between studies, possibly due to variation in host genetic factors and venom composition. This study aimed to evaluate predictive factors for death from snake ...
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Introduction-Factors predictive for death from snake envenomation vary between studies, possibly due to variation in host genetic factors and venom composition. This study aimed to evaluate predictive factors for death from snake envenomation in Myanmar.
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Objective: To evaluate clinical and radiographic outcome in dogs with caudal cervical spondylomyelopathy (CCSM) treated with an intervertebral fusion cage and locking plates.Study Design: Prospective clinical study.Animals: Large ...
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Objective: To evaluate clinical and radiographic outcome in dogs with caudal cervical spondylomyelopathy (CCSM) treated with an intervertebral fusion cage and locking plates.Study Design: Prospective clinical study.Animals: Large breed dogs (n = 14) with CCSM.Methods: Dogs had single level cervical spine distraction/fusion performed using an intervertebral cage with a hollow center filled with cancellous autograft and 2 ventrally applied locking plates. Outcome was measured using neurologic scores and radiographic interpretation 6 weeks, 6 months, and 12 months postoperatively.Results: The surgical procedure was well tolerated in all dogs. Final outcome at 12 months was available in 9 dogs. Five dogs were judged excellent, 1 dog was good, 2 dogs were satisfactory, and 2 dogs were poor because of adjacent segment disease. Four dogs died for reasons unrelated to the procedure. Radiographically, implants remained stable over the entire follow-up period. The disc space continued to fill with an immature pattern of new bone, which showed progressive increase in opacity and quantity. Subsidence of the cage (median 2mm) was detected in 9 dogs at 6 weeks and remained unchanged in those that could be followed further.Conclusion: Distraction-fusion of single level CCSM in dogs with a combination of intervertebral cage and ventral locking plates is clinically effective and results in successful bony fusion.
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OBJECTIVES: The aim of this prospective study was to evaluate the 5-year performance and success rate of titanium screw-type implants with the titanium plasma spray (TPS) or the sand-blasted, large grit, acid-etched (SLA) surface ...
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OBJECTIVES: The aim of this prospective study was to evaluate the 5-year performance and success rate of titanium screw-type implants with the titanium plasma spray (TPS) or the sand-blasted, large grit, acid-etched (SLA) surface inserted in a two-stage sinus floor elevation (SFE) procedure in the posterior maxilla. MATERIAL AND METHODS: A total of 59 delayed SFEs were performed in 56 patients between January 1997 and December 2001, using a composite graft with autogenous bone chips combined with deproteinized bovine bone mineral (DBBM) or synthetic porous beta-tricalcium phosphate (beta-TCP). After a healing period averaging 7.75 months, 111 dental implants were inserted. After an additional 8-14-week healing period, all implants were functionally loaded with cemented crowns or fixed partial dentures. The patients were recalled at 12 and 60 months for clinical and radiographic examination. RESULTS: One patient developed an acute infection in the right maxillary sinus after SFE and did not undergo implant therapy. Two of the 111 inserted implants had to be removed because of a developing atypical facial pain, and 11 implants were lost to follow-up and were considered drop-outs. The remaining 98 implants showed favorable clinical and radiographic findings at the 5-year examination. The peri-implant soft tissues were stable over time; the mean probing depths and mean attachment levels did not change during the follow-up period. The measurement of the bone crest levels (DIB values) indicated stability as well. Based on strict success criteria, all 98 implants were considered successfully integrated, resulting in a 5-year success rate of 98% (for TPS implants 89%, for SLA implants 100%). CONCLUSION: This prospective study assessing the performance of dental implants inserted after SFE demonstrated that titanium implants can achieve and maintain successful tissue integration with high predictability for at least 5 years of follow-up in carefully selected patients.
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BACKGROUND: In 2001, a white paper set out a commitment to ensure that people with a learning disability receive equal access to health services, with an expectation that general practices would have identified all people with a l...
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BACKGROUND: In 2001, a white paper set out a commitment to ensure that people with a learning disability receive equal access to health services, with an expectation that general practices would have identified all people with a learning disability registered with the practice by June 2004. AIM: To outline the development of a template to create practice-based registers of people with learning disabilities in general practice. DESIGN OF STUDY: The study was prospective, employing a template to identify patients in general practice with a learning disability. The study used capture-recapture methodology to estimate the prevalence of learning disability in the population. SETTING: General practices in Leeds. METHOD: A template was developed that uses Read code searches of practices' electronic medical records, along with practice knowledge to identify patients who have a learning disability. RESULTS: The tool was piloted in 30 general practices in Leeds and validated against a city-wide database of people with learning disability. There was a wide variation between the practices in terms of how many people were identified, with the average being 0.4% of the practice population. Combined with validation from the city-wide database, this increased to 0.7%. CONCLUSION: The template provides a valuable tool for general practices to begin developing a practice-based register of patients with a learning disability. This is particularly timely in view of the revised General Medical Services contract Quality and Outcomes Framework indicator, stimulating practices to produce a register of patients with learning disability. Use of a common definition for learning disability is needed to improve consistency in identification across practices.
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Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been ...
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Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been central to the discouraging results from clinical trials. Current approaches to the characterization of disease severity and outcome have not changed in more than three decades. This prospective multicenter observational pilot study aimed to validate the feasibility of implementing the TBI Common Data Elements (TBI-CDEs). A total of 650 subjects who underwent computed tomography (CT) scans in the emergency department within 24 h of injury were enrolled at three level I trauma centers and one rehabilitation center. The TBI-CDE components collected included: 1) demographic, social and clinical data; 2) biospecimens from blood drawn for genetic and proteomic biomarker analyses; 3) neuroimaging studies at 2 weeks using 3T magnetic resonance imaging (MRI); and 4) outcome assessments at 3 and 6 months. We describe how the infrastructure was established for building data repositories for clinical data, plasma biomarkers, genetics, neuroimaging, and multidimensional outcome measures to create a high quality and accessible information commons for TBI research. Risk factors for poor follow-up, TBI-CDE limitations, and implementation strategies are described. Having demonstrated the feasibility of implementing the TBI-CDEs through successful recruitment and multidimensional data collection, we aim to expand to additional study sites. Furthermore, interested researchers will be provided early access to the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) data set for collaborative opportunities to more precisely characterize TBI and improve the design of future clinical treatment trials. (ClinicalTrials.gov Identifier NCT01565551.)
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The relationship between alcohol consumption and the risk for cardiovascular disease (CVD) is U-shaped, whereas alcohol drinking is linearly associated with blood pressure, and the CVD risk also increases linearly according to blo...
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The relationship between alcohol consumption and the risk for cardiovascular disease (CVD) is U-shaped, whereas alcohol drinking is linearly associated with blood pressure, and the CVD risk also increases linearly according to blood pressure level. Accordingly, we investigated the net effect of alcohol consumption and hypertension on CVD and its subtypes in this study. A 13-year prospective study of 2336 Japanese men who were free from CVD was performed; ex-drinkers were excluded. The participants were divided into eight groups classified by the combination of the presence of hypertension (systolic/diastolic blood pressure >=140/90 mm Hg) and alcohol consumption (never-, current- (light, moderate and heavy) drinkers). Multivariate-adjusted hazard ratios (HRs) for the incidence of CVD, coronary artery disease (CAD) and stroke due to the combination of hypertension and alcohol consumption were calculated and compared with non-hypertensive never-drinkers. The HRs for CVD and its subtypes were higher in hypertensives than those in non-hypertensives; in hypertensives without medication for hypertension, the relationship between alcohol consumption and the risks for CVD and CAD was U-shaped, with the highest and most significant increase in never-drinkers. The risk for total stroke was the highest in heavy-drinkers, which was significant. In non-hypertensives, there was no evident increase or decrease in the HRs for CVD and its subtypes in drinkers. Accordingly, controlling blood pressure is important to prevent CVD. In hypertensives, heavy drinking should be avoided to prevent CVD, although light-to-moderate drinking could be protective for CAD. Furthermore, in non-hypertensives, drinkers may need to continuously monitor their blood pressure.
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Objectives: The object of this study was to introduce the KORean Observational study Network for Arthritis (KORONA) registry with an emphasis on the design of the Korean rheumatoid arthritis (RA) national database, as well as to p...
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Objectives: The object of this study was to introduce the KORean Observational study Network for Arthritis (KORONA) registry with an emphasis on the design of the Korean rheumatoid arthritis (RA) national database, as well as to provide an overview of the RA patients who are currently registered in KORONA. Methods: The KORONA was established in July 2009 by the Clinical Research Center for Rheumatoid Arthritis (CRCRA) in South Korea. KORONA is based on a prospective protocol and standard, defined data collection instruments. Demographic and clinical features, laboratory and radiologic data, health-related outcomes, treatment side effects, resource utilization, and health behaviors of the RA cohort patients are recorded in a database. Results: A total of 23 institutions, which are about 38% of the rheumatologic departments at tertiary academic hospitals across South Korea, are part of KORONA. The quality control of data collection and management has been performed through annual monitoring and auditing, staff training, and providing standard operation protocol by the executive committee of CRCRA. As of 31 December 2010, 4721 patients with established RA were included in KORONA, because an annual survey had started to be performed in July 2010. Conclusions: KORONA is the first nationwide Korean RA-specific cohort and it will provide valuable "real-world" information for Korean RA patients.
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