Observational Study Of Effect Research Articles

Observational study of effects of HIV acquisition and antiretroviral treatment on biomarkers of systemic immune activation.

To assess whether biomarkers of systemic inflammation are associated with HIV acquisition or with the timing of ART initiation ("immediate", at diagnosis, versus "deferred", at 24 weeks post-diagnosis) in men-who-have-sex-with-men (MSM) and transgender women, we conducted a retrospective study comparing inflammatory biomarkers in participants' specimens collected before infection and after ≥2 years of effective ART. We measured biomarkers in four longitudinally collected plasma, including two specimens collected from each participant before and two after HIV acquisition and confirmed ART-suppression. Biomarkers were quantified by enzyme-linked immuno-assay or Meso Scale Discovery. When evaluating systematic variation in these markers over time, we found that multiple biomarkers consistently varied across participants' two pre-infection or two post-ART-suppression specimens. Additionally, we compared changes in biomarkers after vs before HIV acquisition. Across 47 participants, the levels of C-reactive protein (CRP), monocyte chemo-attractant protein-1, tumor necrosis factor-α and interferon gamma-induced protein-10 significantly increased while leptin and lipopolysaccharide binding protein (LBP) significantly decreased following HIV infection. Randomization to deferred-ART initiation was associated with greater increases in CRP and no decrease in LBP. Acquisition of HIV appeared to induce systemic inflammation, with elevation of biomarkers previously associated with infections and cardiovascular disease. Initiation of ART during the early weeks of infection tempered the increase in pro-inflammatory biomarkers compared to delaying ART for ~24 weeks after HIV diagnosis. These findings provide insight into potential mediators by which immediate-ART initiation improves health outcomes, perhaps because immediate-ART limits the size of the HIV reservoir or limits immune dysregulation that in turn trigger systemic inflammation.

An Observational Study of Effect of Umbilical Cord Entanglement on Mode of Delivery and Perinatal Outcome

An Observational Study of Effect of Umbilical Cord Entanglement on Mode of Delivery and Perinatal Outcome

Open-label observational study of effectiveness and tolerability of ipidacrine in treatment of patients with diabetic polyneuropathy (DIAMANT study)

Diabetic polyneuropathy (DPN) is one of the most common complications of diabetes mellitus, leading to the development of flaccid paresis, neuropathic pain syndrome, sensitive ataxia, as well as trophic disorders in the distal parts of the lower extremities.The purpose of the randomized, open-label, comparative, prospective study was to evaluate the effectiveness and tolerability of ipidacrine in the complex treatment of patients with DPN.Materials and methods. Patients with DPN (n = 60) were randomized into 2 groups. Both groups received basic therapy (alpha-lipoic acid, B vitamins, gabapentin); in the treatment of patients of the main group (n = 30), in addition, ipidacrine was used (Ipidacrine-SZ, North Star Co., Russia). We have analyzed the intensity of pain syndrome (VAS-P), the average daily dosage of gabapentin, and the results of the neuropathic dysfunctional scale (modified version, NDSm), Pittsburgh Sleep Quality Index, PSQI), Global Rating of Change Scale (GROC), the results of electroneuromyography (ENMG). The total duration of the observation and treatment period was 2 months.Results. After 2 months of therapy in the main group of patients, compared with the control group, there was significantly more complete pain control (VAS-P: 3.0 ± 0.9 vs 3.6 ± 0.8), a decrease in the average daily dosage of gabapentin (390 vs 500 mg/day), reduction in the severity of clinical manifestations of polyneuropathic syndrome (NDSm: 4.4 ± 1.0 vs 4.9 ± 1.0 points) and improvement in sleep quality (PSQI: 6.8 ± 1.3 vs 7.9 ± 1.7). According to ENMG data, patients in the main group showed a significant improvement in the neurophysiological parameters of both motor and sensory fibers, which was significantly more pronounced compared to the control group. A significantly larger proportion of patients in the main group assessed the improvement from the therapy as ‘pronounced’ (GROC: 10/33.3 % vs 6/20.0 %).Conclusions. The use of ipidacrine in complex therapy of patients with DPN can significantly reduce the clinical manifestations of disease and improve the neurophysiological parameters of the peripheral nerves of the lower extremities. Ipidacrine can be considered as a basic drug for the treatment of patients with neurological complications of diabetes mellitus.

An observational study of effect of mullerian anomalies on pregnancy

An observational study of effect of mullerian anomalies on pregnancy

EP12.01-52 A Multi-Center Observational Study of Effectiveness and Safety of First Line Afatinib in Major Uncommon EGFR mutated NSCLC

EP12.01-52 A Multi-Center Observational Study of Effectiveness and Safety of First Line Afatinib in Major Uncommon EGFR mutated NSCLC

Observational Study of Effectiveness of Ligation of Intersphinsteric Fistula Tract (Lift) in Perianal Fistulas Operated at AIIMS Patna

Background: Perianal fistula or fistula-in-ano, is a chronic abnormal communication, usually lined by granulation tissue, which runs outwards from the anorectal lumen (the internalopening) to an external opening on the skin of the perineum and gluteal region. Perianal fistula develops as a result of anorectal sepsis. Ligation of intersphincteric fistula tract (LIFT) is a new sphincter saving method with good result in the management of fistula. The aim of study was to evaluate the effectiveness and functional outcomes of the LIFT patients operated at AIIMS Patna.

Impact of Chronic Coronary Artery Disease and Revascularization Strategy in Patients with Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Implantation

The prognostic impact of coronary artery disease (CAD) after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study is to investigate the impact of CAD and different revascularization strategies on clinical outcomes in patients who underwent TAVI with third generation devices. Patients enrolled in the national observational Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment II study were stratified according to the presence of CAD (CAD+, n=1,130) versus no CAD (CAD-, n=1,505), and compared using a propensity matched analysis. CAD+ group was further stratified according to the revascularization strategy: no revascularization (n=331), revascularization performed >90days before index-TAVI (n=417) and coronary revascularization performed <90days before index-TAVI or during TAVI (n=382). In-hospital, 30-day and 1-year clinical outcomes were estimated. The mean age of the overall population was 81.8years; 54.9% of patients were female. Propensity score matching yielded 813 pairs and their 30-day all-cause mortality was comparable (p=0.480). Major periprocedural adverse events were also similar between the groups. At 1-year follow-up, the rate of major adverse cardiac and cerebrovascular events (MACCEs) and all-cause mortality were similar between the groups (p=0.732 and p=0.633, respectively). Conversely, patients with CAD experienced more often myocardial infarction and need for percutaneous coronary intervention at 1year (p=0.007 and p=0.001, respectively). Neither CAD nor revascularization strategy were independent predictors of 1-year MACCE. About 40% of patients presenting with severe AS and who underwent TAVI had concomitant CAD. The presence of CAD had no impact on all-cause mortality and MACCE 1-year after TAVR. However, CAD carries a higher risk for acute myocardial infarction and need of percutaneous coronary intervention during follow-up.

Financial Burden of Transcatheter Aortic Valve Implantation

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p=0.76) and the mean age (82.0 vs 82.1y, p=0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs.

Pros and Cons of Randomized Controlled Trials and Benchmarking Controlled Trials in Rehabilitation: An Academic Debate within the European Academy of Rehabilitation Medicine

The European Academy of Rehabilitation Medicine (EARM) held a debate in Hannover, Germany, on 1st of September 2016 on the pros and cons of randomized controlled trials (RCTs) and observational effectiveness studies (benchmarking controlled trials; BCTs). The debate involved a chairperson, a person presenting the substance of the debate, an opponent, and a rapporteur. The academicians participated in the discussion. Eight propositions and proposed statements formed the substance of the debate. There was agreement that a study question should be the starting point of an effectiveness study, and not the study method, i.e. RCT or BCT. The term “benchmarking” was questioned: does it mean market-oriented medicine? It was clarified that benchmarking refers to the methodological features of this study design: there must always be a comparison between peers. It was agreed that BCTs might be better than RCTs for use in rehabilitation studies, in which one often needs multi-centred studies, such as in the assessment of the effectiveness of pathways when there is complexity of processes, health systems, organizational issues, structures and facilities; or where interactions between therapists, doctors and patients differ between centres; and when assessing the implementation of rehabilitation. In addition, BCTs may deal with ethical issues, e.g. the acceptability of interventions, more easily than RCTs. Recommendations regarding the different approaches (RCTs or BCTs) should be provided by the scientific rehabilitation societies. Concern over the validity of BCTs was considered justified, as the validity criteria of BCTs cover all those related to RCTs and include the risk of selection bias between treatment arms. Appropriate description of the essentials of the study object, including adequate description of how the interventions were actualized in comparison to the study plan, are essential features for a valid and generalizable study for both RCTs and BCTs. BCTs are necessary to widen the evidence-base of effectiveness in rehabilitation. It was suggested that the rehabilitation field should support the concept of BCTs. It was proposed that education regarding BCTs is indicated, and stakeholders need to be convinced that BCTs are a valid alternative to RCTs. EARM and other physical and rehabilitation medicine (PRM) bodies could advance the use of BCTs for clinical and health policy decision-making.LAY ABSTRACTThe European Academy of Rehabilitation Medicine (EARM) held a debate on the strengths and limitations of randomized controlled trials (RCTs) and observational effectiveness studies, also known as benchmarking controlled trials (BCTs), in rehabilitation. The main substance of the debate involved eight propositions and four proposed statements. The term “benchmarking” was questioned: does it mean market-oriented medicine? It was clarified that, as benchmarking refers to the features of the study design; there must be comparison between peers. It was agreed that BCTs might be better than RCTs for use in rehabilitation studies: one often needs multi-centred studies and assessment of the effectiveness of pathways; the rehabilitation processes are complex, and health systems and organizational issues are essential; and the essential interactions between therapists, doctors and patients differ between centres. Also, BCTs may deal with ethical issues more efficiently than RCTs. It was recommended that both RCTs and BCTs should be used in rehabilitation research. An essential feature of a valid and generalizable study (for both RCTs and BCTs) is appropriate description of the essentials of the study object. BCTs were considered necessary for widening the evidence-base of effectiveness in rehabilitation, and the rehabilitation field should support the concept of BCTs. It was proposed that education regarding BCTs is indicated, and stakeholders need to be convinced that BCTs are a valid alternative to RCTs. The EARM and other physical and rehabilitation medicine (PRM) bodies should advance the use of BCTs for clinical and health policy decision-making.

Covariate Balance for Observational Effectiveness Studies: A Comparison of Matching and Weighting

Propensity score matching and weighting methods are often used in observational effectiveness studies to reduce imbalance between treated and untreated groups on a set of potential confounders. However, much of the prior methodological literature on matching and weighting has yet to examine performance for scenarios with a majority of treated units, as is often encountered with programs and interventions that have been widely disseminated or “scaled-up.” Using a series of Monte Carlo simulations, we compare the performance of k:1 matching with replacement and weighting methods with respect to covariate balance, bias, and mean squared error. Results indicate that the accuracy of all methods declined as treatment prevalence increased. While weighting produced the largest reduction in covariate imbalance, 1:1 matching with replacement provided the most unbiased treatment effect estimates. An applied example using empirical school-level data is provided to further illustrate the application and interpretation of these methods to a real-world scale-up effort. We conclude by considering the implications of propensity score methods for observational effectiveness studies with a particular focus on educational research.

A clinical observational study of effectiveness of a solid coupling medium in extracorporeal shock wave lithotripsy

This study aimed to investigate clinical effectiveness of stone disintegration by using isolation coupling pad (“icPad”) as coupling medium to reduce trapped air pockets during extracorporeal shock wave lithotripsy (ESWL). Patients underwent ESWL between Oct. 2017 and May 2018 were enrolled in this clinical observational study. An electromagnetic lithotripter (Dornier MedTech Europe GmbH Co., Germany) was used in this study. Patients were divided into icPad group P1, P2 and semi-gel group C by different coupling medium. The energy level and total number of shock wave (SW) for group P1 and C was set at level 2 and 3000 and group P2 at level 3 and 2500. The successful stone disintegration rate (SSDR) was determined to evaluate the treatment outcome. All patients were evaluated by KUB film and ultrasonography after 90 days. Complications during ESWL were recorded. A total of 300 patients satisfied the inclusion criteria. There were no significant differences in characteristics of patients and stone among three groups. The corresponding SSDRs for patients in group P1, P2 and C was 73.0%, 73.2% and 55.3%, respectively. The SSDR in group P1 was statistically higher than Group C. Comparing to semi-liquid gel, coupling medium using by icPad could achieve better treatment outcome of stone disintegration in ESWL.

HIV Care Coordination promotes care re-engagement and viral suppression among people who have been out of HIV medical care: an observational effectiveness study using a surveillance-based contemporaneous comparison group

BackgroundMedical care re-engagement is critical to suppressing viral load and preventing HIV transmission, morbidity and mortality, yet few rigorous intervention studies address this outcome. We assessed the effectiveness of a Ryan White Part A-funded HIV Care Coordination Program relative to ‘usual care,’ for short-term care re-engagement and viral suppression among people without recent HIV medical care.MethodsThe Care Coordination Program was launched in 2009 at 28 hospitals, health centers, and community-based organizations in New York City. Designed for people with HIV (PWH) experiencing or at risk for poor HIV outcomes, the Care Coordination Program provides long-term, comprehensive medical case management utilizing interdisciplinary teams, structured health education and patient navigation. The intervention was implemented as a safety-net services program, without a designated comparison group. To evaluate it retrospectively, we created an observational, matched cohort of clients and controls. Using the HIV surveillance registry, we identified individuals meeting program eligibility criteria from December 1, 2009 to March 31, 2013 and excluded those dying prior to 12 months of follow-up. We then matched clients to controls on baseline status (lacking evidence of viral suppression, consistently suppressed, inconsistently suppressed, or newly diagnosed in the past 12 months), start of follow-up and propensity score. For this analysis, we limited to those out of care at baseline (defined as having no viral load test in the 12 months pre-enrollment) and still residing within jurisdiction (defined as having a viral load or CD4 test reported to local surveillance and dated within the 12-month follow-up period). Using a GEE model with binary error distribution and logit link, we compared odds of care re-engagement (defined as having ≥ 2 laboratory events ≥ 90 days apart) and viral suppression (defined as having HIV RNA ≤ 200 copies/mL on the most recent viral load test) at 12-month follow-up.ResultsAmong 326 individuals out of care at baseline, 87.2% of clients and 48.2% of controls achieved care re-engagement (Odds Ratio: 4.53; 95%CI 2.66, 7.71); 58.3% of clients and 49.3% of controls achieved viral suppression (Odds Ratio: 2.05; 95%CI 1.30, 3.23).ConclusionsHIV Care Coordination shows evidence of effectiveness for care and treatment re-engagement.

Programmed cell death protein-1 inhibitors in the treatment of digestive system tumors in Chinese population: an observational study of effectiveness and safety.

Tumor of the digestive system is a common malignancy with high morbidity and mortality. Although programmed cell death-1 (PD-1) inhibitors have become an effective treatment strategies for many kinds of tumors, there is still some uncertainty in digestive tumors, including: (I) therapeutic effects of PD-1 inhibitors are relatively limited; (II) responses of digestive system tumors to immunotherapies are highly heterogeneous. In the present study, we investigated the outcomes of PD-1 inhibitors for digestive system tumors in Chinese patients to analyze factors that may affect the effects of immunotherapies in digestive system tumors. Data were obtained from the Hospital Information System (HIS) of the Department of Digestive Oncology (Henan Cancer Hospital) between January 2019 and December 2019. Inclusion criteria included patients receiving the same PD-1 inhibitor continuously for advanced or recurrent/metastatic digestive system tumors. Indicators including age, sex, clinical diagnosis, height, weight, gene status, PD-1 inhibitors, treatment regimen, medication cycle, efficacy evaluation results, and adverse reactions were analyzed retrospectively. The clinical outcomes were progression-free survival (PFS) and safety. A total of 2,767 patients were discharged from HIS, of which 64 (37 male/27 female) were included in this study. Thirty-eight (59.4%) of the patients were aged <60 years. Tumors included esophageal, gastric, liver, colorectal, and pancreatic cancer. Up until 30 June 2020, 51 patients were followed up to median progression-free survival (PFS), which was 5 months; the longest PFS was 18.5 months. There was no statistical significance in grouping according to sex, age and body mass index. Nevertheless, the median PFS differed statistically between monotherapy (9.4 months) versus combined therapy (4.7 months), and Cox regression analysis suggested that patients might benefit more from monotherapy than combined therapy. The incidence of adverse reactions was 47.7%, with thyroid dysfunction the most common adverse reaction. The incidence of grade 3-4 adverse reactions was 9.2% and mainly included pulmonary infection, immune-associated hepatitis, and severe oral ulcers. In digestive tumors, especially for second-line treatment and beyond, PD-1 monotherapy might be more beneficial than combined therapy. However, this might be related to the patient's tolerance. Large-sample prospective studies are needed for confirmation.

Adaptation to Online Technology for Learning during COVID-19 Pandemic: An Observational Study of Effectiveness and Student’s Perception in Various Universities

Introduction: COVID-19 is a newly discovered infectious disease caused by a virus named ‘coronavirus’. To control the rapid spread of the virus, Indian government announced lockdown in whole country. The lockdown has largely affected the lives of students because education was shifted from traditional classroom learning to online learning. After COVID 19 pandemic the online teaching-learning has become more prevalent in India, it becomes particularly important to know its effectiveness and to know whether it’s actually helping the students to achieve what they expect. Aim: The present study was designed to understand the effectiveness, student’s perspective, attitudes and readiness about online classes being conducted at the University level. Materials and Methods: An observational, descriptive study was conducted with a total sample size of 400. Students studying in four different universities were included in the study. The data was collected using a Questionnaire. A semi structured, self-administered questionnaire was prepared on Google Forms with open and close ended questionnaire and was circulated among university going students via WhatsApp and e-mail. The data was tabulated by Google spreadsheet. SPSS version 20 was used for data analysis. Results: Out of 400 students, who participated in the study, 55.25% students liked and 44.75% disliked online teaching during the lockdown period. However, 90.5% said that classroom was an effective platform for learning in comparison to online learning. Total of 6.5% subjects were completely satisfied, 24.5% somewhat satisfied and 8.25% were completely unsatisfied with online learning experience. A 44.75% student also felt difficult to spend several hours on mobile or computer. Conclusion: After analysing the results, it was concluded that the students liked the online classes but are not interested in continuing the same way after the lockdown. They felt that classroom teaching was more effective than online learning due to issues related to topic understanding, net connectivity, and lack of practical and/or demonstrations. Hence, certain improvements must be made to increase its acceptability amongst students.

Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study).

AimEvaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥36 months with 0.5mg ranibizumab.MethodsOpen-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5±1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists’ best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis.ResultsThe mean±SD number of treatments in the first year was 5.1±3.0 (TX-naïve), 4.5±2.7 (PRIOR-anti-VEGF) and 5.6±3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9±16.4 letters from 59.7±9.3 at baseline in TX-naïve (p<0.0001), by 11.8±9.9 from 61.6±8.5 in PRIOR-anti-VEGF (p=0.03), and by 4.2±10.6 from 58.2±14.6 in PRIOR-other groups (p=0.0002). BCVA remained stable for the remainder of follow-up in all groups. CRT decreased over the first 2 months by monthly rates of −43.8µm in TX-naïve (p=0.04), −75.7µm in PRIOR-anti-VEGF (p=0.02), and −65.8µm in PRIOR-other eyes (p=0.0003), showing stability afterwards. No unknown adverse events were recorded; a painful eye following injection was registered with a possible relationship to the treatment.ConclusionThis real-world study confirms the effectiveness of ranibizumab in preventing a decline in BCVA and demonstrated initial improvement and subsequent retention of BCVA in DME patients ≥36 months. Ranibizumab initially reduced and then maintained CRT. However, these data reveal that treatment intensity and BCVA and CRT outcomes are lower than those found in early efficacy trials. Under-treatment likely accounts for this efficacy-effectiveness gap. Yet, intravitreal ranibizumab is an effective and safe long-term treatment for DME under conditions of significant heterogeneity in patients and treatment patterns.

An observational study of effect of use of smart phones on sleep – a pilot study.

An observational study of effect of use of smart phones on sleep – a pilot study.

Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: Results from the OBSERVANT study.

We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI. Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (<65, 65-74, and 75-79 years). Patients <80 years of age with severe symptomatic AS undergoing TAVI (n = 483) had significantly higher Logistic EuroSCORE (10.84% vs. 5.22%, p < .001) and prevalence of comorbidities compared to subjects undergoing SAVR (n = 4,318). The decision to perform TAVI over SAVR was driven by anatomical factors, mainly previous cardiac surgery (odds ratio [OR] 24.73, confidence interval [CI] 12.71-48.10, p < .001) and the presence of porcelain aorta (OR 17.44, CI 6.67-45.55, p < .001), and clinical factors, mainly moderate-severe frailty score (OR 5.49, CI 3.33-9.07, p < .001), oxygen dependency (OR 7.42, CI 2.75-20.04, p < .001) and need for dialytic treatment (OR 5.24, CI 1.54-17.80, p < .008). Among patients undergoing TAVI, those under 65 years had the highest baseline risk profile (despite a low Logistic EuroSCORE) and the highest 5-year mortality compared to those 65-74 and 75-79-year-old (65.22% vs. 48.54% vs. 55.24%, log-rank p = .061). Among patients under 80 years of age with symptomatic severe AS, only 10% underwent TAVI. These patients were at higher baseline risk compared to those undergoing SAVR. The decision to perform TAVI was driven by the presence of both anatomical and clinical factors beyond surgical risk scores. Patients under 65 years of age, despite the low Logistic EuroSCORE, had the highest preoperative risk profile and carried the worse outcome.

Using Approximation Algorithms to Build Evidence Factors and Related Designs for Observational Studies

Observational or nonrandomized studies of treatment effects are often constructed with the aid of polynomial-time algorithms that optimally form matched treatment-control pairs or matched sets. Because each observational comparison may potentially be affected by bias, investigators often reinforce a single comparison with an additional comparison that is unlikely to be affected by the same biases, for instance using multiple control groups or evidence factors or control + instrument designs. Use of two comparisons affected by different biases may detect bias if the two comparisons disagree, or may show that two comparisons with different weakness concur in their conclusions. Even this simplest addition—a second comparison—creates design problems without polynomial-time solutions. Faced with a problem that no polynomial-time algorithm can solve, a so-called approximation algorithm is a type of compromise: it provides a solution in polynomial time that is provably not much worse than the unattainable optimal solution. Building upon existing techniques for related problems in operations research, we develop an approximation algorithm for minimum distance matching with near-fine balance for three comparison groups. This algorithm is a practical approach to most observational designs that add a second comparison. The method is applied to an observational study of the effects of side airbags on injury severity in the U.S. Fatality Analysis Reporting System. For many car makes and models, side airbags were initially unavailable, then later available as optional equipment for an additional fee, then still later provided as standard equipment. Within sets matched for make and model of car, for safety belt use, for direction of impact, and other covariates, we compare crashes in these three periods, where each comparison has different limitations. The method is implemented in the R package approxmatch, whose example reproduces some of the calculations. Supplementary materials for this article are available online.

Effects of haemodialysis on Hemoglobin and red cell indices in chronic kidney disease patients at a tertiary health care institute

Background: Chronic kidney disease (CKD) is a global health problem, with very high cost of care and greater burden particularly in developing countries like India.Material and Method: This prospective observational study of effects on hemoglobin and red cell indices in CKD before and after hemodialysis conducted on 150 CKD patients in SRM Medical College Hospital & Research Centre.Results: The most frequent morphologic features were normochromic-normocytic (78.7%), microcytic hypochromic (14.7%), macrocytic (3.3%) and dimorphic (3.3.%). Haemoglobin (Hb) levels and platelets counts are significantly reduced in post dialysis with a mean level of Hb 8.7 when compared to pre dialysis mean value of 7.78g/dL. There was a significant increase in MCV, with decrease in MCH and MCHC in the post dialysis values compared to pre dialysis.Conclusion: These hematological abnormalities expose CKD patients to higher risk of anemia-related complications. The present investigation might help clinicians to initiate precautions before and after dialysis procedures.