Population-based Clinical Studies Research Articles

Validation and evaluation of subject-specific finite element models of the pediatric knee

Finite element (FE) models have been widely used to investigate knee joint biomechanics. Most of these models have been developed to study adult knees, neglecting pediatric populations. In this study, an atlas-based approach was employed to develop subject-specific FE models of the knee for eight typically developing pediatric individuals. Initially, validation simulations were performed at four passive tibiofemoral joint (TFJ) flexion angles, and the resulting TFJ and patellofemoral joint (PFJ) kinematics were compared to corresponding patient-matched measurements derived from magnetic resonance imaging (MRI). A neuromusculoskeletal-(NMSK)-FE pipeline was then used to simulate knee biomechanics during stance phase of walking gait for each participant to evaluate model simulation of a common motor task. Validation simulations demonstrated minimal error and strong correlations between FE-predicted and MRI-measured TFJ and PFJ kinematics (ensemble average of root mean square errors < 5 mm for translations and < 4.1° for rotations). The FE-predicted kinematics were strongly correlated with published reports (ensemble average of Pearson's correlation coefficients (ρ) > 0.9 for translations and ρ > 0.8 for rotations), except for TFJ mediolateral translation and abduction/adduction rotation. For walking gait, NMSK-FE model-predicted knee kinematics, contact areas, and contact pressures were consistent with experimental reports from literature. The strong agreement between model predictions and experimental reports underscores the capability of sequentially linked NMSK-FE models to accurately predict pediatric knee kinematics, as well as complex contact pressure distributions across the TFJ articulations. These models hold promise as effective tools for parametric analyses, population-based clinical studies, and enhancing our understanding of various pediatric knee injury mechanisms. They also support intervention design and prediction of surgical outcomes in pediatric populations.

Probiotic: is diet part of the efficacy equation?

ABSTRACT Discovered at the beginning of the 20th century by Nobel laureate Élie Metchnikoff, probiotics have more recently emerged as a potential noninvasive therapeutic approach for the treatment of various chronic diseases. However, recent population-based clinical studies suggest that probiotics are often ineffective and may even exhibit potential deleterious effects. Hence, a deeper molecular understanding of strain-specific beneficial effects, together with the identification of endogenous/exogenous factors modulating probiotic efficacy, is needed. The lack of consistency in probiotic efficacy, together with the observation that numerous preclinical findings on probiotics are not translating once applied to humans through clinical trials, suggests a central role for environmental factors, such as dietary patterns, in probiotic efficacy. Two recent studies have been instrumental in filling this knowledge gap, defining the role played by diet in probiotic efficacy on metabolic deregulations in both mouse models and humans .

Population-Based Clinical Studies Using Routinely Collected Data in Hong Kong, China: A Systematic Review of Trends and Established Local Practices

Background: Routinely collected health data are increasingly used in clinical research. No study has systematically reviewed the temporal trends in the number of publications and analyzed different aspects of local research practices and their variations in Hong Kong, China, with a specific focus on research ethics governance and approval. Methods: PubMed was systematically searched from its inception to March 28, 2023, for studies using routinely collected healthcare data from Hong Kong. Results: A total of 454 studies were included. Between 2000 and 2009, 32 studies were identified. The number of publications increased from 5 to 120 between 2010 and 2022. Of the investigator-led studies using the Hospital Authority (HA)’s cross-cluster data (n = 393), 327 (83.2%) reported receiving ethics approval from a single cluster/university-based REC, whereas 50 studies (12.7%) did not report approval from a REC. For use of the HA Data Collaboration Lab, approval by a single hospital-based or University-based REC is accepted. Repeated submission of identical ethics applications to different RECs is estimated to cost HK$4.2 million yearly. Conclusions: Most studies reported gaining approval from a single cluster REC before retrieval of cross-cluster HA data. Substantial cost savings would result if repeated review of identical ethics applications were not required.

Population-Based Clinical Studies Using Routinely Collected Data in Hong Kong: A Systematic Review of Established Local Practices and Counterfactual Analysis

Population-Based Clinical Studies Using Routinely Collected Data in Hong Kong: A Systematic Review of Established Local Practices and Counterfactual Analysis

High Plasma Apolipoprotein(a) Concentration and Low Plasmin Tpa Enzymatic Activity in Hospitalized Patients with COVID-19

Thrombotic and thromboembolic complications in patients diagnosed with coronavirus disease 2019 (COVID-19) are emerging as important sequelae that contribute to mortality, including disseminated intravascular coagulation, pulmonary embolism, deep vein thrombosis, ischemic stroke, and myocardial infraction. Reported incidence of thrombotic and thromboembolic complications in moderate/severe COVID-19 patients is from 21% to 49%, while even higher incidence in non-surviving COVID-19 patients. However, the underlying mechanism between thrombosis and COVID-19 is still unclear.Tissue-type plasminogen activator (tPA) plays an important role on initiating fibrinolysis by converting zymogen plasminogen to plasmin, a serine protease that degrades the fibrin clot, and therefore preventing excessive pathological blood clots. A homologous protein to plasminogen is apolipoprotein(a) [apo(a)], a major component of lipoprotein(a). The apo(a) inhibits fibrinolysis and exacerbates thrombosis through blocking the conversion from Glu-plasminogen to Lys-plasminogen, which has a higher binding affinity to fibrin and is a better substrate to tPA. The population distribution of plasma apo(a) level is positively skewed (most values are clustered around the left tail of the distribution close to zero), and the plasma apo(a) level in most people is less than 300 μg/mL. High plasma concentration of apo(a) (> 300 μg/mL), or genetic variants of LPA, the gene that encodes for apo(a), correlates with thrombotic cardiovascular risk and thromboembolic risk in many population-based clinical or genetic studies. To investigate the potential correlation between infection of SARS-COV-2 and thrombosis, we tested de-identified plasma samples collected from hospitalized patients with or without positivity of SARS-CoV-2 testing results and COVID-19 diagnosis (ICD10CM:U07.1) through the COVD-19 Tissue Bank at the Medical College of Wisconsin. The tPA enzymatic activity was measured by the release of p-nitroaniline chromophore from a plasmin-specific synthetic substrate with exogenous human plasminogen, with the intensity of color proportional to tPA activity. The apo(a) concentration is measured by ELISA capturing total apo(a) antigen.Our results show that the SARS-CoV-2-positive inpatients have higher plasma tPA concentration than the SARS-CoV-2 negative inpatients (6.0 versus 3.0 ng/mL, p<0.05), while plasma tPA enzymatic activity is lower in SARS-CoV-2-positive inpatients than the SARS-CoV-2 negative inpatients (15.2 versus 25.5 ΔA/min/mL/10 4, p<0.0001) (Figure A). The plasma apo(a) concentration is significantly higher in SARS-CoV-2-positive inpatients than in the plasma from SARS-CoV-2-negative inpatients (the median of the two groups are 114.8 versus 34.4 μg/mL, p<0.05) (Figure B). Among the 20 hospitalized patients with COVID-19, 13 survived. The 13 survived patients have one additional plasma sample collected after recovering from COVID-19 (date range between the two blood collections of onset and after recovery is from 19 to 87 days, the mean duration is 42 days). After recovery, 11 out of 13 surviving patients have increased plasma tPA enzymatic activity (the mean value at onset versus recovery is 5.2 versus 7.1 ΔA/min/mL/10 4, p<0.05) (Figure C). Consistently, 11 out of 13 surviving patients have decreased plasma apo(a) concentration compared to the plasma collected during the onset of COVID-19 from the same individuals (the median values of the onset and recovery are 141.1 versus 106.5 μg/mL, p<0.001) (Figure D).In summary, our study shows lower tPA enzymatic activity and higher apo(a) concentration in SARS-CoV-2-positive hospitalized patients compared to SARS-CoV-2-negative hospitalized patients. Among the survived patients, the reduction of apo(a) concentration after recovering from COVID-19 is accordance with the increase of tPA enzymatic activity. Considering the role of apo(a) in inhibiting fibrinolysis through limiting tPA-mediated plasminogen to plasmin conversion, the alteration in apo(a) concentration provide a possible explanation of change of tPA activity in patients with severe COVID-19. [Display omitted] DisclosuresBaumann Kreuziger: CSL Behring: Consultancy; Quercegen Pharmaceuticals: Consultancy; Vaccine Injury Compensation Program: Consultancy.

Efficient Identification of Patients Eligible for Clinical Studies Using Case-Based Reasoning on The Scottish Health Research Register (SHARE)

IntroductionTrials often struggle to achieve their target sample size with only half doing so. Some researchers have turned to Electronic Health Records (EHRs), seeking a more efficient way of recruitment. The Scottish Health Research Register (SHARE) obtained patients’ consent for their EHRs to be used as a searching base from which researchers can find potential participants. However, due to the fact that EHR data is not complete, sufficient or accurate, a database search strategy may not generate the best case-finding result. Objectives and ApproachA retrospective study was conducted to evaluate the performance of a case-based reasoning method in identifying participants for population-based clinical studies which had recruited through SHARE. A case-based reasoning framework was applied to nine studies with 119 total participants using two-fold cross-validation. Records of 30,000 random individuals were also merged with each test set to simulate the real-world recruitment setting. A prediction score for study participation was generated for each one in the test set through comparison of their diagnosis, procedure, pharmaceutical prescription, and laboratory test results attributes and those of the participants of a particular study. Evaluation was conducted by calculating Area Under the ROC Curve and information retrieval metrics for the ranking list of the test set by prediction score. We also compared the most likely participants as identified by searching a database to those ranked highest by our model. ResultsThe average ROCAUC for nine projects was 81% indicating strong predictive ability. However, the derived ranking lists showed lower predictive performance. 21% of the persons ranked within top 50 positions being the same as identified by searching databases. Conclusion / ImplicationsCase-based reasoning may be more effective than database search strategy for participant identification. This hypothesis requires a prospective study for further validation. The lower performance of ranking lists suggests improvements are needed in the collection and curation of EHRs.

Efficient identification of patients eligible for clinical studies using case-based reasoning on Scottish Health Research register (SHARE)

BackgroundTrials often struggle to achieve their target sample size with only half doing so. Some researchers have turned to Electronic Health Records (EHRs), seeking a more efficient way of recruitment. The Scottish Health Research Register (SHARE) obtained patients’ consent for their EHRs to be used as a searching base from which researchers can find potential participants. However, due to the fact that EHR data is not complete, sufficient or accurate, a database search strategy may not generate the best case-finding result. The current study aims to evaluate the performance of a case-based reasoning method in identifying participants for population-based clinical studies recruiting through SHARE, and assess the difference between its resultant cohort and the original one deriving from searching EHRs.MethodsA case-based reasoning framework was applied to 119 participants in nine projects using two-fold cross-validation, with records from a further 86,292 individuals used for testing. A prediction score for study participation was derived from the diagnosis, procedure, pharmaceutical prescription, and laboratory test results attributes of each participant. Evaluation was conducted by calculating Area Under the ROC Curve and information retrieval metrics for the ranking list of the test set by prediction score. We compared the most likely participants as identified by searching a database to those ranked highest by our model.ResultsThe average ROCAUC for nine projects was 81% indicating strong predictive ability for these data. However, the derived ranking lists showed lower predictive performance, with only 21% of the persons ranked within top 50 positions being the same as identified by searching databases.ConclusionsCase-based reasoning is may be more effective than a database search strategy for participant identification for clinical studies using population EHRs. The lower performance of ranking lists derived from case-based reasoning means that patients identified as highly suitable for study participation may still not be recruited. This suggests that further study is needed into improvements in the collection and curation of population EHRs, such as use of free text data to aid reliable identification of people more likely to be recruited to clinical trials.

Middle East respiratory syndrome coronavirus (MERS-CoV): threats, gaps and containment strategies

Presenter: Hamid Hussain, Consultant, Family and Community Medicine, Faculty of Medicine, University of Baghdad; Dubai Health Authority, Dubai, United Arab Emirates Background: Middle East respiratory syndrome coronavirus (MERS-CoV) causing acute severe respiratory diseases was first reported in 2012 in Saudi Arabia. The causative agent was identified as a coronavirus which was named MERS-CoV. Purpose: This study reviewed the published literature to investigate the incidence and mortality rate of MERS-CoV to identify the main threats and gaps and frame containment strategies. Methodology: MEDLINE and CINAHL electronic databases were searched using a pre-defined search strategy. Additional references from the bibliographies of retrieved articles were also reviewed and experts (respiratory disease consultants) involved in case management in the United Arab Emirates were contacted. Selection criteria were: original research articles on MERS-CoV incidence. The initial literature search identified 47 papers. Of these, 16 original articles met the selection criteria. All were type II evidence— population-based clinical MERS-CoV studies. Findings: Since 2012 cases have been reported in 14 countries, with most of the reporting from the Arabian Peninsula region. A total of 212 cases have been reported in Saudi Arabia up to April 2014, of which 88 died. The countries most affected by the disease are Saudi Arabia with 183 cases, of which 74 (40 %) died and the United Arab Emirates with 19 cases, of which 7 (37 %) died. So far, all the cases have been linked to six countries in or near the Arabian Peninsula. No cases have been identified in the United States of America. The virus has spread from sick people to others through close contact. Conclusions: The disease is following a propagated epidemic curve and trending to more spreading and adding more and more cases. In time, increasing numbers of index cases will lead to a change in the epidemiological curve pattern to an explosive epidemic curve, which is considered threatening for coronavirus as the case fatality rate is extremely high and mortality rate can reach up to 50 %. Gap analysis studies are needed to determine why the virus is still circulating and propagating in spite of the advanced preventive and control measures applied so far. The main question that needs to be addressed is how to reach the sources of infection and to break the transmission chain. Keywords MERS-CoV; Incidence

Cerebral palsy prevalence, subtypes, and associated impairments: a population‐based comparison study of adults and children

To describe the prevalence of cerebral palsy (CP), subtype distribution, motor and intellectual impairment, and epilepsy in adults with CP compared with children with CP. CP subtype and impairment data from the population-based CP register of western Sweden and population data from Statistics Sweden were used to compare surviving adults (n=581; 244 females, 337 males) born between 1959 and 1978, with the same cohort as children (n=723; 307 females, 416 males), andwiththe most recent cohort, born from 2007 to 2010 (n=205; 84 females, 121 males). Prevalence of CP in adults born between 1959 and 1978 was 1.14 per 1000. The occurrence of impairments differed between CP subtypes. Motor and intellectual impairment were closely related, regardless of subtype. Subtype distribution among survivors differed significantly from the original cohorts (p=0.002), and the most recent cohort (p<0.01), tetraplegia and dyskinetic CP being less common in survivors. Severe motor impairment, intellectual disability, and epilepsy were less common among survivors than in the original cohorts (p=0.004, p=0.002, p=0.037) and the most recent cohort (p=0.004, p=0.008, p<0.01). Data on prevalence, subtype distribution, and impairments in children with CP are not applicable to adults with CP. Population-based studies of adults with CP are needed. Cerebral palsy (CP) subtypes are differently distributed in adults compared to children. The prevalence of impairments in adults with CP is related to CP subtype. Spastic tetraplegia and dyskinetic CP are less common in adults than children. Severe motor impairment, intellectual disability, and epilepsy are less common in adults.

Determinants of Seasonal Influenza Vaccine Uptake Among the Elderly in the United States: A Systematic Review and Meta-Analysis.

Background: Despite the availability of a universal influenza vaccination program in the United States and Canada, seasonal influenza vaccine (SIV) uptake among the elderly remains suboptimal. Understanding the factors that determine SIV uptake in this important population subgroup is essential for designing effective interventions to improve seasonal influenza vaccination among the elderly. We evaluated the determinants of SIV uptake in the elderly in the United States and Canada. Methods: We systematically searched relevant bibliographic databases and websites from 2000 to 2017 for population-based clinical trials or observational studies conducted in community-based elderly individuals in the United States or Canada, irrespective of health status. Two reviewers independently screened the identified citations for eligibility using a two-stage sifting approach to review the title/abstract and full-text article. We gathered data on determinants of uptake (any vaccine receipt) and adherence (receipt of vaccine in more than one season) to seasonal influenza vaccination. Where possible, we pooled the data using inverse variance methods to minimize the variance of the weighted average. Results: Five cross-sectional studies on SIV uptake (none on adherence) from the United States met our eligibility criteria. Being older (pooled odds ratio [POR] = 1.44, 95% Confidence Interval [CI] = 1.11, 1.86); White (POR = 1.33, 95% CI = [1.10, 1.64]); and having higher income (POR = 1.06, 95% CI = [1.04, 1.09]); and health insurance (POR = 1.40, 95% CI = [1.25, 1.55]) were associated with increased SIV uptake. Conclusion: Older, ethnically White, higher income elderly individuals with access to health insurance coverage and a regular health care provider have higher SIV uptake in the United States. There was limited evidence for other socioeconomic and health-related determinants. Further studies are needed to provide an evidence base for planning more effective influenza vaccination programs in the United States.

The influence of neoadjuvant therapy for the prognosis in patients with rectal carcinoma: a retrospective study.

Rectal cancer, defined as a cancerous lesion of the colon distal to the rectosigmoid junction, is the fourth most common cancer cause of death globally. There were 474 patients with rectal cancer who underwent surgery between October 2007 and May 2013 enrolled in our center. Patients were respectively categorized by neoadjuvant therapy. This study aimed to explore the predictive factors that affected the Progression-free survival and overall survival of the patients with rectal cancer. Clinical characteristics of patients were compared with the groups and potential prognostic factors were analyzed by SPSS 19.0. In our study, neoadjuvant therapy increased the anus-retained rate (64.4 vs 53.4% P = 0.016) and remission rate in the treatment group, compared to the non-treatment group (62.6 vs 34.8%; P = 0.000). The neoadjuvant concurrent chemoradiotherapy, more operative duration, anus retained and micturition damaged are positive prognostic factors of PFS to patients. Poor differentiation, the tumor of ulcer, invasive, and pT4 stage, contributed the poor factors for PFS of patients (P < 0.05). Additionally, the patients with neoadjuvant concurrent chemoradiotherapy and adjuvant chemotherapy underwent the better prognosis of OS. Adjuvant chemotherapy cannot increase PFS of the patients who accepted neoadjuvant therapy after surgery get pCR, but can improve OS. The anus-retained and neoadjuvant radiotherapy, duration of surgery in rectal cancer have the positive correlation. Micturition damaged and neoadjuvant radiotherapy were positively correlated as well. In conclusion, adjuvant chemotherapy does not improve the PFS of patients with pCR to neoadjuvant therapy, but is good for OS. Further prospective and large population-based clinical studies are needed to establish clinical guidelines for the use of neoadjuvant therapy and adjuvant chemotherapy in patients with rectal cancer.

The Long-Term Influence of Tissue Inhibitor of Matrix Metalloproteinase-1 in Patients with Mild to Moderate Coronary Artery Lesions in a Chinese Population: A 7-Year Follow-Up Study

Objectives: Matrix metalloproteinase-9 (MMP-9), tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) and their ratio (MMP-9/TIMP-1) are involved in multiple processes that are associated with coronary heart disease and are especially associated with cardiovascular events. However, few long-term population-based clinical studies have evaluated the role of these factors in cardiovascular events in a Chinese population. Methods: A prospective study was performed on 560 patients with mild to moderate coronary artery lesions. MMP-9, TIMP-1 and their ratio were determined. Results: A total of 522 of patients completed the follow-up. The median follow-up time was 64 months. Kaplan-Meier analysis demonstrated a clear increase of the incidence of major adverse cardiac events (MACEs) during the follow-up period in subjects with above-median levels of TIMP-1 (p = 0.033), whereas there was no association with either MMP-9 (p = 0.199) or MMP-9/TIMP-1 (p = 0.631). Multivariate Cox proportional hazards analysis showed the same results after further adjustment for covariates. Patients with above-median levels of TIMP-1 were more likely to suffer from adverse outcomes than patients with below-median levels of TIMP-1. However, the lack of relationship of MACEs with MMP-9 and MMP-9/TIMP-1 remained. Conclusions: Higher circulating TIMP-1 concentrations were associated with cardiovascular events during long-term follow-up of Chinese patients with mild to moderate coronary artery lesions.

Calcium Fructoborate Helps Control Inflammation Associated with Diminished Bone Health

Inflammation has been identified as a possible contributory factor to disruption of the normal bone remodeling process, a process essential to healthy bone mineral density. Several large population-based clinical studies have specifically shown that levels of C-reactive protein, an immune recognition protein that is a sensitive marker of inflammation, are inversely and independently associated with total bone mineral density. The evidence suggests that control of C-reactive protein levels may contribute to bone health by protecting against inflammation's disruption of the equilibrium between bone resorption and bone deposition. Calcium fructoborate, a patented complex of calcium, fructose, and boron found naturally in fresh and dried fruits, vegetables and herbs, and wine, is a sugar-borate ester. A growing body of peer-reviewed, published clinical research indicates that the calcium fructoborate significantly reduces serum levels of the C-reactive protein in humans, suggesting that this unique plant-mineral complex may contribute to bone health by controlling the inflammation associated with loss of bone mineral density.

Screening for Ovarian Cancer: A Reality Check

Detection of stage I neoplastic disease has become the major goal for cancer prevention and reduction of cancer-associated mortality. Whereas this goal is realized in many human solid tumors, including carcinomas arising from breast, endometrium, prostate, and gastrointestinal tract, it has become a tantalizing objective in ovarian cancer. Several population-based clinical studies designed to screen for early stage ovarian cancer fail to provide a clinically satisfied positive predictive value and, as a result, lead to several unnecessary surgeries that are associated with higher morbidity and mortality. One of the reasons is that high-grade serous carcinoma—the most common and lethal ovarian cancer—may likely arise from fallopian tube epithelium and involve the ovary secondarily. Therefore, “ovarian” cancer is unlikely ever stage I at presentation. This commentary will briefly summarize the recent findings in ovarian cancer screening and discuss the challenges, promise, and reality for early detection of ovarian cancer.

Association of Lipoprotein Subfractions and Coronary Artery Calcium In Patient at Intermediate Cardiovascular Risk

More precise estimation of the atherogenic lipid parameters could improve identification of residual risk beyond what is possible using traditional lipid risk factors. The aim of the present study was to explore the association between advanced analysis of lipoprotein subfractions and the prevalence of coronary artery calcium. Consecutive participants at intermediate cardiovascular risk who were undergoing computed tomographic assessment of coronary calcium (calcium score) were included. Using a validated ultracentrifugation method (the vertical autoprofile II test), cholesterol in eluting lipoprotein subfractions [i.e., low- (LDL), very-low-, intermediate-, and high-density lipoprotein subclasses, lipoprotein (a), and predominant LDL distribution] was directly quantified. A total of 410 patients were included (29% women, mean age 57 years), of whom 297 (72.4%) had coronary artery calcium. LDL pattern B (predominance of small dense particles) emerged as an independent predictor of coronary calcium after adjustment for traditional risk factors (odds ratio 4.46, 95% confidence interval 1.19 to 16.7). However, after additional stratification for dyslipidemia, as defined by conventional lipid profiling, a statistically significant prediction was only retained for high-density lipoprotein subfraction 2 (odds ratio 3.45, 95% confidence interval 2.03 to 50.1) and "real" LDL (odds ratio 6.10, 95% confidence interval 1.26 to 23.41) in the normolipidemia group and for lipoprotein (a) (odds ratio 7.81, 95% confidence interval 1.41 to 43.5) in the dyslipidemic group. In conclusion, advanced assessment of the lipoprotein subfractions [i.e., LDL pattern B, high-density lipoprotein subfraction 2, "real" LDL, and lipoprotein (a)] using the vertical autoprofile II test provided additional information to that of conventional risk factors on the prevalence of coronary artery calcium in patients at intermediate cardiovascular risk.

La investigación en atención primaria como área de conocimiento. Informe SESPAS 2012

Primary care offers huge potential for research. This setting is an area of knowledge that must expand to improve the quality of its services and patients’ health. Population-based clinical studies with a focus on health promotion and primary, secondary and tertiary disease prevention offer unique research opportunities. Developing research in the biopsychosocial model of clinical practice and new models of integrated healthcare and community care is therefore a priority. The framework and activities carried out by the Research Network in Preventive Activities and Health Promotion have been instrumental in the development of research in primary care in Spain. Despite the efforts invested by various institutions, foundations, teaching and research departments in primary care research, the projected outputs in terms of volume, quality and impact have not been achieved. The involvement of primary care professionals in research platforms is insufficient, with scarce contribution toward investment in specific primary care research projects. To change the current status of research in primary care, a number of measures are required, namely, the consolidation of research organisms specific to primary care with adequate allocation of funding and staff, and the allocation of specific time for research to primary care professionals to enable them to produce significant projects and consolidate established research lines in their areas of expertise, with applications mainly in quality improvement and innovation of primary care services.

Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage

Subarachnoid hemorrhage (SAH) is a common and frequently devastating condition, accounting for ≈5% of all strokes and affecting as many as 30 000 Americans each year.1,2 The American Heart Association (AHA) previously published “Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage.”3 Since then, considerable advances have been made in endovascular techniques, diagnostic methods, and surgical and perioperative management paradigms. Nevertheless, outcome for patients with SAH remains poor, with population-based mortality rates as high as 45% and significant morbidity among survivors.4–9 Several multicenter, prospective, randomized trials and prospective cohort analyses have influenced treatment protocols for SAH. However, rapid evolution of newer treatment modalities, as well as other practical and ethical considerations, has meant that rigorous clinical scientific assessment of the treatment protocols has not been feasible in several important areas. To address these issues, the Stroke Council of the AHA formed a writing group to reevaluate the recommendations for management of aneurysmal SAH. A consensus committee reviewed existing data in this field and prepared the recommendations in 1994.3 In an effort to update those recommendations, a systematic literature review was conducted based on a search of MEDLINE to identify all relevant randomized clinical trials published between June 30, 1994, and November 1, 2006 (search terms: subarachnoid hemorrhage , cerebral aneurysm , trial ; Table 1). Each identified article was reviewed by at least 2 members of the writing group. Selected articles had to meet one of the following criteria to be included: randomized trial or nonrandomized concurrent cohort study. Case series and nonrandomized historical cohort studies were reviewed if no studies with a higher level of evidence were available for a particular topic covered in the initial guidelines. These were chosen on the basis of sample size and the relevance of the particular studies to subjects that …

Clinical characteristics and consequences of hand eczema – an 8‐year follow‐up study of a population‐based twin cohort

Few population-based clinical follow-up studies on hand eczema are reported. The aim of this study was to characterize clinical symptoms and to examine occupational and medical consequences as well as persistence of hand eczema in a population-based twin cohort. A total of 274 individuals with and without hand eczema were examined, patch tested, and interviewed in 1997-1998 and 2005-2006. Data on 188 individuals with hand eczema in 2005-2006 were analysed. Erythema and scaling were the most frequent symptoms, and fingers and palms were most often affected. Mean hand eczema severity index score in individuals with clinical symptoms was 12.0. Sick leave was reported by 12.4%; job change by 8.5%. Being in the lowest socio-economic group and atopic dermatitis were risk factors for sick leave [odds ratio (OR) = 5.6; 95% confidence interval (95% CI) 1.5-22.9 and OR = 2.9; 95% CI 1.0-8.1]. The majority (63.4%) had seen a doctor at least once, and atopic dermatitis was a risk factor for more than 1 visit (OR = 3.0; 95% CI 1.4-6.4). Duration of >10 years was a risk factor for persistence of symptoms, which was reported by 67.7%. The clinical picture and consequences of hand eczema vary; however, the majority experience chronic symptoms.

The Periodontitis and Vascular Events (PAVE) Pilot Study: Recruitment, Retention, and Community Care Controls

Population-based clinical and laboratory studies have reported findings providing support for a possible relationship between periodontal disease and cardiovascular disease. The Periodontitis and Vascular Events (PAVE) pilot study was conducted to investigate the feasibility of a randomized secondary prevention trial to test whether treatment of periodontal disease reduces the risk for cardiovascular disease. Five clinical centers recruited participants who had documented coronary heart disease and met study criteria for periodontal disease. Eligible participants were randomized to receive periodontal therapy provided by the study or community dental care. Follow-up telephone calls and clinic visits were planned to alternate at 3-month intervals after randomization, with all participants followed until at least the 6-month clinic visit. Participants were followed for adverse events and periodontal and cardiovascular outcomes. A total of 303 participants were randomized. Recruitment that involved active participation of a cardiologist with responsibility for the patients worked best among the strategies used. Of those who had not withdrawn, 93% completed the 6-month contact. During follow-up, 11% of the 152 subjects in the community dental care group reported receiving periodontal therapy outside of the study. If appropriate recruitment strategies are used, this pilot study demonstrated that it is feasible to conduct a secondary prevention trial of periodontal therapy in patients who have had coronary heart disease. If a community dental care group is used, sample size estimation needs to take into account that a non-trivial proportion of participants in this group may receive periodontal therapy outside of the study.

Guidelines for the Diagnosis and Management of Hypertrophic Cardiomyopathy

Definition and Prevalence H cardiomyopathy (HCM) is a primary cardiac disorder characterised by hypertrophy, usually of the left ventricle, in the absence of other loading conditions, such as aortic stenosis, hypertension or thyroid disease. Although previously thought of as a rare disorder, recent population-based clinical studies suggest the increases with the Valsalva manoeuvre and is related to dynamic obstruction. There is frequently a fourth heart sound. The echocardiogram is the investigation which most reliably confirms the diagnosis of HCM and which provides detailed information about the distribution and severity of hypertrophy, the left ventricular cavity size, assessment of left ventricular systolic and diastolic function, left ventricular outflow tract obstruction (in