62 research outputs found
Role of semen analysis in the diagnosis of infertility at a tertiary care centre in Western India: a prospective study
Background: The prevalence of infertility in the general population is 15%-20%. Of this, the male factor is responsible for 20%-40%. In Indian couples seeking treatment, the male factor is the cause in approximately 23%. Semen analysis is an indispensable diagnostic tool in the evaluation of the male partners of infertile couples. Careful evaluation of the ejaculate parameters may suggest the possible causes of infertility and their identification could help to institute appropriate therapy, if available.Methods: Semen samples were analyzed by manual method. An analysis for volume, viscosity, sperm concentration, motility, and morphology, according to WHO guidelines on semen analysis was done.Results: This study, done at a tertiary care center at Western India, at M.G.M hospital has demonstrated that abnormal semen quality is a major factor contributing to infertility in couples.28% males had volume <2 ml, 70% had sperm count <20 million/ml and 72% had sperms with abnormal morphology.Conclusions: Semen analysis remains a significant contribution in the overall diagnosis of infertility in our environment and semen analysis is an indispensable diagnostic tool in the evaluation of the male partners of infertile couples. Males contribute towards infertility in couples significantly and further study and assessment is required to accurately predict the importance of this
Mycobacterium tuberculosis H37Ra: a surrogate for the expression of conserved, multimeric proteins of M.tb H37Rv
Additional file 3. Details of primers used, experimental and theoretical molecular weights, pI values and details of post-translational modifications in GAPDH
Longitudinal cohort study investigating neurodevelopmental and socioemotional outcomes in school-entry aged children after open heart surgery in Australia and New Zealand: the NITRIC follow-up study protocol
Introduction: Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children <2 years of age, investigating the effect of gaseous nitric oxide applied into the cardiopulmonary bypass oxygenator during heart surgery. The NITRIC follow-up study will follow this cohort annually until 5 years of age to assess outcomes related to cognition and socioemotional behaviour at school entry, identify risk factors for adverse outcomes and evaluate the performance of screening tools.
Methods and analysis: Approximately 1150 children from the NITRIC trial across five sites in Australia and New Zealand will be eligible. Follow-up assessments will occur in two stages: (1) annual online screening of global neurodevelopment, socioemotional and executive functioning, health-related quality of life and parenting stress at ages 2–5 years; and (2) face-to-face assessment at age 5 years assessing intellectual ability, attention, memory and processing speed; fine motor skills; language and communication; and socioemotional outcomes. Cognitive and socioemotional outcomes and trajectories of neurodevelopment will be described and demographic, clinical, genetic and environmental predictors of these outcomes will be explored.
Ethics and dissemination: Ethical approval has been obtained from the Children’s Health Queensland (HREC/20/QCHQ/70626) and New Zealand Health and Disability (21/NTA/83) Research Ethics Committees. The findings will inform the development of clinical decision tools and improve preventative and intervention strategies in children with CHD. Dissemination of the outcomes of the study is expected via publications in peer-reviewed journals, presentation at conferences, via social media, podcast presentations and medical education resources, and through CHD family partners.Trial registration numberThe trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as ‘Gene Expression to Predict Long-Term Neurodevelopmental Outcome in Infants from the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) Study – A Multicentre Prospective Trial’. Trial registration: ACTRN12621000904875
Inflammation gene variants and susceptibility to albuminuria in the U.S. population: analysis in the Third National Health and Nutrition Examination Survey (NHANES III), 1991-1994
<p>Abstract</p> <p>Background</p> <p>Albuminuria, a common marker of kidney damage, serves as an important predictive factor for the progression of kidney disease and for the development of cardiovascular disease. While the underlying etiology is unclear, chronic, low-grade inflammation is a suspected key factor. Genetic variants within genes involved in inflammatory processes may, therefore, contribute to the development of albuminuria.</p> <p>Methods</p> <p>We evaluated 60 polymorphisms within 27 inflammatory response genes in participants from the second phase (1991-1994) of the Third National Health and Nutrition Examination Survey (NHANES III), a population-based and nationally representative survey of the United States. Albuminuria was evaluated as logarithm-transformed albumin-to-creatinine ratio (ACR), as ACR ≥ 30 mg/g, and as ACR above sex-specific thresholds. Multivariable linear regression and haplotype trend analyses were conducted to test for genetic associations in 5321 participants aged 20 years or older. Differences in allele and genotype distributions among non-Hispanic whites, non-Hispanic blacks, and Mexican Americans were tested in additive and codominant genetic models.</p> <p>Results</p> <p>Variants in several genes were found to be marginally associated (uncorrected P value < 0.05) with log(ACR) in at least one race/ethnic group, but none remained significant in crude or fully-adjusted models when correcting for the false-discovery rate (FDR). In analyses of sex-specific albuminuria, <it>IL1B </it>(rs1143623) among Mexican Americans remained significantly associated with increased odds, while <it>IL1B </it>(rs1143623), <it>CRP </it>(rs1800947) and <it>NOS3 </it>(rs2070744) were significantly associated with ACR ≥ 30 mg/g in this population (additive models, FDR-P < 0.05). In contrast, no variants were found to be associated with albuminuria among non-Hispanic blacks after adjustment for multiple testing. The only variant among non-Hispanic whites significantly associated with any outcome was <it>TNF </it>rs1800750, which failed the test for Hardy-Weinberg proportions in this population. Haplotypes within <it>MBL2</it>, <it>CRP</it>, <it>ADRB2, IL4R</it>, <it>NOS3</it>, and <it>VDR </it>were significantly associated (FDR-P < 0.05) with log(ACR) or albuminuria in at least one race/ethnic group.</p> <p>Conclusions</p> <p>Our findings suggest a small role for genetic variation within inflammation-related genes to the susceptibility to albuminuria. Additional studies are needed to further assess whether genetic variation in these, and untested, inflammation genes alter the susceptibility to kidney damage.</p
Hepatic and renal end-organ damage in the Fontan circulation: a report from the Australian and New Zealand Fontan Registry
Background: Hepatic and renal dysfunction have been observed in survivors of the Fontan procedure, however their incidence and associated factors remain poorly defined. Methods: A total of 152 participants from a Registry of 1528 patients underwent abdominal ultrasound, transient elastography (FibroScan), serum fibrosis score (FibroTest), in vivo Tc-99m DTPA measurement of glomerular filtration rate (mGFR), and urine albumin-creatinine ratio (ACR). Results: Mean age and time since Fontan were 19.8 ± 9.3 and 14.1 ± 7.6 years, respectively. Features suggestive of hepatic fibrosis were observed on ultrasound in 87/143 (61%) and no patient was diagnosed with hepatocellular carcinoma. FibroScan median kPa was ≥10 in 117/133 (88%), ≥15 in 75/133 (56%), and ≥20 in 41/133 (31%). Fifty-four patients (54/118, 46%) had a FibroTest score ≥0.49 (equivalent to ≥F2 fibrosis). FibroTest score correlated with FibroScan value (r = 0.24, p = 0.015) and ACR (r = 0.29, p = 0.002), and patients with ultrasound features of hepatic fibrosis had a higher FibroScan median kPa (19.5 vs 15.4, p = 0.002). Renal impairment was mild (mGFR 60–89 ml/min/1.73 m) in 46/131 (35%) and moderate (mGFR 30–59 ml/min/1.73 m) in 3/131 (2%). Microalbuminuria was detected in 52/139 participants (37%). By multivariable analysis, time since Fontan was associated with increased FibroScan median kPa (β = 0.89, 95% CI 0.54–1.25, p = 0.002) and decreased mGFR (β = −0.77, 95% CI −1.29–0.24, p = 0.005). Conclusions: In the second decade after Fontan hepatic and renal structure and function are abnormal in a significant number of patients: close to 60% have ultrasonographic evidence of structural hepatic abnormalities, 46% have elevated serum hepatic fibrosis scores, and 57% have either reduced glomerular filtration rate or microalbuminuria. Hepatic and renal function should be monitored for potential impacts on outcomes after Fontan completion
Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement
Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions
Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries
Abstract
Background
Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres.
Methods
This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries.
Results
In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia.
Conclusion
This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries
The Fontan procedure in Australia and New Zealand: an outcomes-based registry to improve the lives of those born with a single ventricle
© 2014 Dr. Ajay IyengarIn the forty years since its introduction, the Fontan procedure has allowed a generation of children who would otherwise have died to survive into adulthood. These children, born with congenital heart disease at the worst end of the spectrum, must undergo a series of operations, ultimately resulting in bypass of the structures in their heart that were absent or poorly-formed. The resulting “Fontan circulation” consists of direct connection of the systemic venous return to the pulmonary circulation. As this population ages and grows, the long-term uncertainties of a procedure that was once considered palliative have remained unresolved. These uncertainties range from basic facts such as life expectancy, to complex considerations surrounding medication choices and family planning. Evolution of surgical techniques, patient selection and perioperative care have resulted in reductions in surgical mortality. However, patients remain at risk of long-term complications including arrhythmias, thromboembolism, heart failure and sudden death. Due to the small numbers of patients and heterogeneous range of conditions treated with the Fontan procedure, study of the long-term outcomes and risk factors in this population, beyond single large centres, has been difficult.
For this reason, we created the Australia and New Zealand Fontan Registry. Now the largest registry of its kind in the world, it aims to (i) encourage population-based, longitudinal follow-up, (ii) understand the composition, outcomes and risk factors of the population, (iii) improve health service planning and provision and (iv) provide a base for recruiting patients to prospective studies. This thesis describes the fulfilment of these aims. Based on the data collected in creation of the registry, I present our current understanding of the population, their outcomes and risk factors for early- and late-postoperative adverse events and, finally, present initial data demonstrating the utility of the Registry as a platform for prospective hypothesis-generated research.
Through the creation of the Registry, I have demonstrated that:
(i) the Fontan population in Australia and New Zealand now numbers over 1000 individuals, half of whom are of adult age,
(ii) there has been a recent rise in the proportion with hypoplastic left heart syndrome to 15% in the current era,
(iii) early outcomes have improved, with contemporary hospital mortality falling to 1%,
(iv) the earliest surgical techniques have been abandoned in favour of the contemporary extracardiac conduit technique,
(v) long-term survival is over 76% at 25 years, which has far exceeded previous expectations, and
(vi) there is a high prevalence of liver and renal dysfunction in long-term survivors.
The journey involved in the creation of the registry began when I was a medical student, reviewing the outcomes of those operated at the Royal Children’s Hospital. The ensuing career-defining journey for me personally, as well as the whole research team, forms an ongoing labour of love for all involved
Direct Price Control on Patented Drugs in India: The Probable Effects on Innovations and Access to Medicines
Addressing the growing concern stemming from the issue of access to and affordability of drugs, this article argues for the use of a direct price control mechanism to prevent the abuse of monopoly rights emerging from the patenting of pharmaceutical products. The article also demonstrates the limited utility of compulsory licensing in achieving access to medicines, and explodes the myth of direct price control necessarily hindering innovation, consequently putting forward a persuasive case for reformulating and rigorously implementing India\u27s hitherto impotent price control regime
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