We describe here a multicentric community-dwelling cohort of older adults (
The four sites of this cohort are in northern (Ballabgarh), southern (Chennai), eastern (Kolkata) and western (Pune) parts of India. We enrolled 5336 participants across 4220 households and began surveillance in July 2018 for viral respiratory infections with additional participants enrolled annually. Trained field workers collected data about individual-level and household-level risk factors at enrolment and quarterly assessed frailty and grip strength. Trained nurses surveilled weekly to identify acute respiratory infections (ARI) and clinically assessed individuals to diagnose acute lower respiratory infection (ALRI) as per protocol. Nasal and oropharyngeal swabs are collected from all ALRI cases and one-fifth of the other ARI cases for laboratory testing. Cost data of the episode are collected using the WHO approach for estimating the economic burden of seasonal influenza. Handheld tablets with Open Data Kit platform were used for data collection.
The attrition of 352 participants due to migration and deaths was offset by enrolling 680 new entrants in the second year. All four sites reported negligible influenza vaccination uptake (0.1%–0.4%), low health insurance coverage (0.4%–22%) and high tobacco use (19%–52%). Ballabgarh had the highest proportion (54.4%) of households in the richest wealth quintile, but reported high solid fuel use (92%). Frailty levels were highest in Kolkata (11.3%) and lowest in Pune (6.8%). The Chennai cohort had highest self-reported morbidity (90.1%).
The findings of this cohort will be used to inform prioritisation of strategies for influenza and RSV control for older adults in India. We also plan to conduct epidemiological studies of SARS-CoV-2 using this platform.
Large data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analysed the factors associated with mortality in a cohort of moderately and severely ill patients with COVID-19 enrolled in a randomised trial on convalescent plasma.
Secondary analysis of data from a Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease.
39 public and private hospitals across India during the study period from 22 April to 14 July 2020.
Of the 464 patients recruited, two were lost to follow-up, nine withdrew consent and two patients did not receive the intervention after randomisation. The cohort of 451 participants with known outcome at 28 days was analysed.
Factors associated with all-cause mortality at 28 days after enrolment.
The mean (SD) age was 51±12.4 years; 76.7% were males. Admission Sequential Organ Failure Assessment score was 2.4±1.1. Non-invasive ventilation, invasive ventilation and vasopressor therapy were required in 98.9%, 8.4% and 4.0%, respectively. The 28-day mortality was 14.4%. Median time from symptom onset to hospital admission was similar in survivors (4 days; IQR 3–7) and non-survivors (4 days; IQR 3–6). Patients with two or more comorbidities had 2.25 (95% CI 1.18 to 4.29, p=0.014) times risk of death. When compared with survivors, admission interleukin-6 levels were higher (p2/FiO2 ratio 10 (9.97, 3.65–27.13, p1.0 mg/L (2.50, 1.14–5.48, p=0.022), ferritin ≥500 ng/mL (2.67, 1.44–4.96, p=0.002) and lactate dehydrogenase ≥450 IU/L (2.96, 1.60–5.45, p=0.001) were significantly associated with death.
In this cohort of moderately and severely ill patients with COVID-19, severity of illness, underlying comorbidities and elevated levels of inflammatory markers were significantly associated with death.
To investigate the association between coagulation parameters and severity of anaemia (moderate anaemia: haemoglobin (Hb) 7–9.9 g/dL and severe anaemia: Hb
A prospective cohort study of pregnant women recruited in the third trimester and followed-up after childbirth.
Ten hospitals across four states in India.
1342 pregnant women.
Hb and coagulation parameters: fibrinogen, D-dimer, D-dimer/fibrinogen ratio, platelets and international normalised ratio (INR) were measured at baseline. Participants were followed-up to measure blood loss within 2 hours after childbirth and PPH was defined based on blood loss and clinical assessment. Associations between coagulation parameters, Hb, anaemia and PPH were examined using multivariable logistic regression models.
Adjusted OR with 95% CI.
In women with severe anaemia during the third trimester, the D-dimer was 27% higher, mean fibrinogen 117 mg/dL lower, D-dimer/fibrinogen ratio 69% higher and INR 12% higher compared with women with no/mild anaemia. Mean platelets in severe anaemia was 37.8x109/L lower compared with women with moderate anaemia. Similar relationships with smaller effect sizes were identified for women with moderate anaemia compared with women with no/mild anaemia. Low Hb and high INR at third trimester of pregnancy independently increased the odds of PPH at childbirth, but the other coagulation parameters were not found to be significantly associated with PPH.
Altered blood coagulation profile in pregnant women with severe anaemia could be a risk factor for PPH and requires further evaluation.
Hyperthyroidism is a common condition affecting up to 3% of the UK population. Treatment improves symptoms and reduces the risk of atrial fibrillation and stroke that contribute to increased mortality. The most common symptom is weight loss, which is reversed during treatment. However, the weight regain may be excessive, contributing to increased risk of obesity. Current treatment options include antithyroid drugs, radioiodine and thyroidectomy. Whether there are differences in either weight change or the long-term cardiometabolic risk between the three treatments is unclear.
The study will establish the natural history of weight change in hyperthyroidism, investigate the risk of obesity and risks of cardiometabolic conditions and death relative to the treatment. The data on patients diagnosed with hyperthyroidism between 1 January 1996 and 31 December 2015 will come from Clinical Practice Research Datalink linked to Hospital Episode Statistics and Office of National Statistics Death Registry. The weight changes will be modelled using a flexible joint modelling, accounting for mortality. Obesity prevalence in the general population will be sourced from Health Survey for England and compared with the post-treatment prevalence of obesity in patients with hyperthyroidism. The incidence and time-to-event of major adverse cardiovascular events, other cardiometabolic outcomes and mortality will be compared between the treatments using the inverse propensity weighting model. Incidence rate ratios of outcomes will be modelled with Poisson regression. Time to event will be analysed using Cox proportional hazards model. A competing risks approach will be adopted to estimate comparative incidences to allow for the impact of mortality.
The study will bring new knowledge on the risk of developing obesity, cardiometabolic morbidity and mortality following treatment for hyperthyroidism to inform clinical practice and public health policies. The results will be disseminated via open-access peer-reviewed publications and directly to the patients and public groups (Independent Scientific Advisory Committee protocol approval #20_000185).
Segments of cerebral basal arterial network (CBAN) dampen the peak pressure in blood flowing through these arteries, thus minimising the chances of development of cerebral aneurysms. The objective of this research was to find the relationship of occurrence of intracranial aneurysms to variations of the components of the CBAN.
This is an observational, quantitative and retrospective research, which used cerebral CT angiography (CCTA) images.
Cerebral CTA of 145 adult patients of both sexes were studied.
Diameters of segments of CBAN were measured in CCTA images and the relative size of each vessel was calculated to standardise for differences in overall arterial sizes among patients. Relationships among sizes of CBAN components were analysed. Presence of aneurysms in different parts of the CBAN was recorded.
Forty-six aneurysms in right internal carotid artery (ICA) and middle cerebral artery (MCA) and 32 aneurysms in left ICA and MCA segments were noted in 42 and 30 patients, respectively. Aneurysms in anterior communicating artery complex and vertebral-basilar arterial segments were seen in 27 and 8 patients, respectively, while they were not detected in parts of posterior cerebral artery (PCA). The significant (p
Variation in segments of CBAN was quantified. The peak pressure dampening mechanism in such arterial segments reduces the chances of development of aneurysms.
To explore the experiences of endometrial scratch (ES) trial participants and site staff of trial recruitment and participation, in order to improve the experience of participants in future trials.
Qualitative study of a subset of participants in the ES randomised controlled trial and a subset of trial site staff.
A purposeful sample of 9 of the 16 UK Fertility Units that participated in the trial.
A purposeful sample of 27 trial participants and 7 site staff.
Participants were largely happy with the recruitment practices, however, some were overwhelmed with the amount of information received. Interviewees had positive preconceptions regarding the possible effect of the ES on the outcome of their in vitro fertilisation (IVF) cycle, which often originated from their own internet research and seemed to be exacerbated by how site staff described the intervention. Some participants appeared to not understand that receiving the ES could potentially reduce their chances of a successful IVF outcome. Those randomised to the control arm discussed feeling discontent; site staff developed mechanisms of dealing with this.
A lack of equipoise in both study participants and the recruiting site staff led to trial participants having positive preconceptions of the potential impact of the ES on their upcoming IVF cycle. Trial participants may not have understood the potential harms of participating in a randomised trial. The trial information sheet did not clearly state this; further research should assess how such information should be presented to potential participants, to proportionately present the level of risk, but to not unduly discourage participation. The amount of information fertility patients require about a research study should also be investigated, in order to avoid participants feeling overwhelmed by the amount of information they receive prior to starting IVF.
After deep vein thrombosis, up to 50% of patients develop post-thrombotic syndrome (PTS). PTS is a chronic condition that reduces quality of life (QOL). Cornerstones of PTS treatment include the use of elastic compression stockings but this treatment is usually incompletely effective and is burdensome. Venoactive drugs have been reported to be effective to treat chronic venous insufficiency (CVI). However, the level of evidence supporting their use in CVI in general and in PTS in particular is low.
The MUFFIN-PTS trial is an academic, publically funded, multicentre randomised placebo-controlled trial assessing the efficacy of micronised purified flavonoid fraction (MPFF, Venixxa), a venoactive drug, to treat PTS. Eighty-six patients with PTS (Villalta score (VS) ≥5) and experiencing at least two of the following PTS manifestations among daily leg heaviness, cramps, pain or oedema will be randomised to receive 1000 mg of oral MPFF or a similar appearing placebo for 6 months, in addition to their usual PTS treatment. Total study follow-up will be 9 months, with visits at inclusion/baseline, 3, 6 and 9 months. Primary outcome is the proportion of patients with improvement in VS in each group, where improvement is defined as a decrease of at least 30% in VS or a VS
Primary ethics approval was received from Centre intégré universitaire de santé et de services sociaux (CIUSSS) West-Central Montreal Research Ethics Board. Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences.
ClinicalTrials.gov Registry (NCT03833024); Pre-results.
by Krishna Kumar, Nandita SaikiaObjectives
Official data on birth is important to monitor the specific targets of SDGs. About 2.7 million children under age five years do not have official birth registration document in India. Unavailability of birth registration document may deprive the children from access to government-aided essential services such as fixed years of formal education, healthcare, and legal protection. This study examines the effect of socioeconomic, demographic and health care factors on birth registration in India. We also examined the spatial pattern of completeness of birth registration that could be useful for district level intervention.Methods
We used data from the National Family Health Survey (NFHS-4), 2015–16. We carried out the descriptive statistics and bivariate analysis. Besides, we used multilevel binary logistic regression to identify significant covariates of birth registration at the individual, district, and state levels. We used GIS software to do spatial mapping of completeness of birth registration at district level.Results
The birth registration level was lower than national average (80.21%) in the 254 districts. In Uttar Pradesh, 12 out of 71 districts recorded lower than 50% birth registration. Also, some districts from Arunachal Pradesh, J&K, and Rajasthan recorded lower than 50% birth registration. We also found a lower proportion of children are registered among children of birth order three and above (62.83%) and rural resident (76.62%). Children of mothers with no formal education, no media exposure, poorest wealth quintile, OBC and muslims religion have lower level of birth registration. Multilevel regression result showed 25 percent variation in birth registration lie between states while the remaining 75 percent variation lie within states. Moreover, children among illiterate mother (AOR = 0.57, CI [0.54, 0.61], p Conclusion
We strongly suggest linking the birth registration facilities with health institutions.
Evidence-based practice (EBP) endeavors to integrate the best available evidence with clinical expertise and patient preference to enhance clinical outcomes. For nurses to effectively demonstrate EBP, the concepts of EBP should be systematically incorporated into the nursing curriculum, with nurse educators playing a pivotal role in execution. However, the effect of EBP training programs on nurse educators remains largely unexplored.
To evaluate the effectiveness of an EBP training program on the knowledge, attitude, practice, and competency of nurse educators.
A pragmatic randomized controlled trial was conducted at a nursing education institution. Fifty-one nurse educators were cluster randomized into intervention and control groups. A 30-hour EBP training intervention was provided for nurse educators in the intervention group. The outcome variables were knowledge, attitude, practice, and competency regarding EBP. These outcomes were evaluated using the EBP knowledge and practice questionnaire, EBP attitude scale, and Fresno test. Data were collected at baseline, the end of 5 months, and the end of 10 months.
Fifty-one eligible participants were enrolled in the study. The intervention and control group had three clusters each with 27 and 24 participants, respectively. Participants in both groups were comparable for variables such as age, years of experience, and educational background (p > .05). Between groups, outcome variables were compared using mixed linear multi-level modeling. Nurse educators who received the EBP training program demonstrated significant differences in knowledge (p < .05), attitude (p < .05), practice (p < .05), and competency scores (p < .05), than that of the control group, indicating the intervention effectiveness.
EBP training programs are effective in improving the knowledge, attitude, practice, and competency of nurse educators.
Hypertension and diabetes mellitus are important risk factors for cardiovascular diseases (CVDs). Once identified with these conditions, individuals need to be linked to primary healthcare system for initiation of lifestyle modifications, pharmacotherapy and maintenance of therapies to achieve optimal blood pressure and glycaemic control. In the current study, we evaluated predictors and barriers for non-linkage to primary-care public health facilities for CVD risk reduction.
We conducted a community-based longitudinal study in 16 urban slum clusters in central India. Community health workers (CHWs) in each urban slum cluster screened all adults, aged 30 years or more for hypertension and diabetes, and those positively screened were sought to be linked to urban primary health centres (UPHCs). We performed univariate and multivariate analysis to identify independent predictors for non-linkage to primary-care providers. We conducted in-depth assessment in 10% of all positively screened, to identify key barriers that potentially prevented linkages to primary-care facilities.
Of 6174 individuals screened, 1451 (23.5%; 95% CI 22.5 to 24.6) were identified as high risk and required linkage to primary-care facilities. Out of these, 544 (37.5%) were linked to public primary-care facilities and 259 (17.8%) to private providers. Of the remaining, 506 (34.9%) did not get linked to any provider and 142 (9.8%) defaulted after initial linkages (treatment interrupters). On multivariate analysis, as compared with those linked to public primary-care facilities, those who were not linked had age less than 45 years (OR 2.2 (95% CI 1.3 to 3.5)), were in lowest wealth quintile (OR 1.8 (95% CI 1.1 to 2.9), resided beyond a kilometre from UPHC (OR 1.7 (95% CI 1.2 to 2.4) and were engaged late by CHWs (OR 2.6 (95% CI 1.8 to 3.7)). Despite having comparable knowledge level, denial about their risk status and lack of family support were key barriers in this group.
This study demonstrates feasibility of CHW-based strategy in promoting linkages to primary-care facilities.
To estimate the current disease burden, trends and future projections for diabetes mellitus (DM) and diabetic retinopathy (DR) in the IQVIA Medical Research Data (IMRD).
We performed a cross-sectional study of patients aged 12 and above to determine the prevalence of DM and DR from the IMRD database (primary care database) in January 2017, involving a total population of 1 80 824 patients with DM. We also carried out a series of cross-sectional studies to investigate prevalence trends, and then applied a double exponential smoothing model to forecast the future burden of DM and DR in the UK.
The crude DM prevalence in 2017 was 5.2%. The DR, sight-threatening retinopathy (STR) and diabetic maculopathy prevalence figures in 2017 were 33.78%, 12.28% and 7.86%, respectively, in our IMRD cross-sectional study. There were upward trends in the prevalence of DM, DR and STR, most marked and accelerating in STR in type 1 DM but slowing in type 2 DM, and in the overall prevalence of DR.
Our results suggest differential rising trends in the prevalence of DM and DR. Preventive strategies, as well as treatment services planning, can be based on these projected prevalence estimates. Improvements that are necessary for the optimisation of care pathways, and preparations to meet demand and capacity challenges, can also be based on this information. The limitations of the study can be overcome by a future collaborative study linking DR screening and hospital eye services data.
To understand the structures and strategies that helped Kerala in fighting the COVID-19 pandemic, the challenges faced by the state and how it was tackled.
Qualitative descriptive study using focus group discussions and in-depth interviews.
State of Kerala, India.
29 participants: four focus group discussions and eight in-depth interviews. Participants were chosen purposively based on their involvement in decision-making and implementation of COVID-19 control activities, from the department of health and family welfare, police, revenue, local self-government and community-based organisations. Districts, panchayats (local bodies) and primary health centres (PHCs) were selected based on epidemiological features of the area like the intensity of disease transmission and preventive/containment activities carried out in that particular area to capture the wide range of activities undertaken in the state.
The study identified five major themes that can inform best practices viz social capital, robust public health system, participation and volunteerism, health system preparedness, and challenges. This study was a real-time exploration of the intricacies of COVID-19 management in a low/middle-income country and the model can serve as an example for other states and nations to emulate or adjust accordingly.
The study shows the impact of synergy of these themes towards more effective solutions; however, further research is much needed in examining the relationship between these factors and their relevance in policy decisions.
Effective identification and management of subclinical left ventricular (LV) dysfunction (LVD) and subclinical atrial fibrillation (AF) by screening elderly populations might be compromised by mild cognitive impairment (MCI). We sought to characterise the prevalence and profile of MCI and evaluate associations with LV and left atrial (LA) dysfunction and AF, in a trial of screening for subclinical LVD and AF.
Australian, community-based intervention trial.
Adults aged ≥65 years with ≥1 LVD risk factors without ischaemic heart disease (n=337).
The Montreal cognitive assessment (MoCA) was obtained. Subclinical LVD was defined as echocardiographic global longitudinal strain ≤16%, diastolic dysfunction or LV hypertrophy; abnormal LA reservoir strain (LARS) was defined as
Subclinical LVD was found in 155 (46%), abnormal LARS in 9 (3.6%) and subclinical AF in 11 (3.8%). MoCA score consistent with MCI (
The 30% prevalence of MCI among elderly subjects with risk factors for subclinical LVD and AF has important implications for screening strategies and management. However, MCI is not associated with subclinical myocardial dysfunction nor subclinical AF.
Australian New Zealand Clinical Trials Registry (ACTRN12617000116325).
by Esther Jie Tian, Sooraj Venugopalan, Saravana Kumar, Matthew BeardBackground
While the delivery of healthcare services within prison systems is underpinned by different models, access to timely and optimal healthcare is often constrained by multifaceted factors. Telehealth has been used as an alternative approach to conventional care. To date, much of the focus has been on evaluation of telehealth interventions within certain geographical contexts such as rural and remote communities. Therefore, the aim of this systematic review was to synthesise the evidence base to date for the impacts of, and outcomes from, telehealth delivered in prisons.Methods
This systematic review was underpinned by best practice in the conduct and reporting of systematic reviews. A systematic search was conducted to reinforce the literature selection process. The modified McMaster Critical Appraisal Tool was used to assess the methodological quality of the included studies. A narrative synthesis of the study outcomes was undertaken.Results
Twenty-nine quantitative studies were included. Telehealth interventions were greatly varied in terms of types of healthcare services, implementation process and intervention parameters. Methodological concerns such as rigour in data collection and analysis, and psychometric properties of outcome measures were commonly identified. Process-related outcomes and telehealth outcomes were the two overarching categories identified.Conclusion
This systematic review provides mixed evidence on the impact of, and outcomes from, telehealth in prisons. While the evidence base does highlight some positive impacts of telehealth, which at the least, is as effective as conventional care while achieving patient satisfaction, it is also important to consider the local context and drivers that may influence what, when and how telehealth services are provided. Addressing critical factors throughout the lifecycle of telehealth is equally important for successful implementation and sustainability.
To explore the experiences and support needs of parents of children with recently diagnosed autism spectrum disorder (ASD) in Singapore.
Raising a child with ASD is challenging for parents, especially in the initial period following the diagnosis. Limited studies have focused on parents’ perspectives.
A qualitative descriptive design study.
Thirteen parents were recruited from a developmental and behavioural paediatric outpatient clinic of a tertiary hospital in Singapore from October–December 2018. Adult parents, who were primary caregivers of 2–10-year-old children diagnosed with ASD in the preceding 3 months to 2 years, were recruited. Semi-structured individual face-to-face interviews were conducted based on an interview guide. Thematic analysis was used to analyse the data. Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist was used for reporting.
Common themes were analysed using constant comparative method to generate results. Four themes emerged after 13 interviews: (1) adjusting psychologically, (2) changing lifestyle, (3) contending with hurdles to services and (4) needing informational, tangible and emotional support.
Findings suggested a need for more formal support networks, targeted resource platforms and accessibility of services to help support parents better after receiving a diagnosis of ASD in their child.
Enhancing current healthcare and social policies to improve the provision of standardised and targeted information to parents, establishing formal support networks, facilitating access to childcare services, and involving domestic helpers/nannies as dedicated caregivers and trainers could better support parents.
by Han Ye, Ujjal Kumar Mukherjee, Dilip Chhajed, Jason Hirsbrunner, Collin RoloffObjectives
Physician encounters with patients with type 2 diabetes act as motivation for self-management and lifestyle adjustments that are indispensable for diabetes treatment. We elucidate the sociodemographic sources of variation in encounter usage and the impact of encounter usage on glucose control, which can be used to recommend encounter usage for different sociodemographic strata of patients to reduce risks from Type 2 diabetes.Data and methods
We analyzed data from a multi-facility clinic in the Midwestern United States on 2124 patients with type 2 diabetes, from 95 ZIP codes. A zero-inflated Poisson model was used to estimate the effects of various ZIP-code level sociodemographic variables on the encounter usage. A multinomial logistic regression model was built to estimate the effects of physical and telephonic encounters on patients’ glucose level transitions. Results from the two models were combined in marginal effect analyses.Results and conclusions
Conditional on patients’ clinical status, demographics, and insurance status, significant inequality in patient encounters exists across ZIP codes with varying sociodemographic characteristics. One additional physical encounter in a six-month period marginally increases the probability of transition from a diabetic state to a pre-diabetic state by 4.3% and from pre-diabetic to the non-diabetic state by 3.2%. Combined marginal effect analyses illustrate that a ZIP code in the lower quartile of high school graduate percentage among all ZIP codes has 1 fewer physical encounter per six months marginally compared to a ZIP code at the upper quartile, which gives 5.4% average increase in the probability of transitioning from pre-diabetic to diabetic. Our results suggest that policymakers can target particular patient groups who may have inadequate encounters to engage in diabetes care, based on their immediate environmental sociodemographic characteristics, and design programs to increase their encounters to achieve better care outcomes.
Current guidelines do not recommend direct oral anticoagulants (DOACs) to treat cerebral venous thrombosis (CVT) despite their benefits over standard therapy. We performed a systematic review to summarise the published experience of DOAC therapy in CVT.
MEDLINE, Embase and COCHRANE databases up to 18 November 2020.
All published articles of patients with CVT treated with DOAC were included. Studies without follow-up information were excluded.
Two independent reviewers screened articles and extracted data. A risk of bias analysis was performed.
Safety data included mortality, intracranial haemorrhage (ICH) or other adverse events. Efficacy data included recurrent CVT, recanalisation rates and disability by modified Rankin Scales (mRS).
33 studies met inclusion criteria. One randomised controlled trial, 5 observational cohorts and 27 case series or studies reported 279 patients treated with DOAC for CVT: 41% dabigatran, 47% rivaroxaban, 10% apixaban and 2% edoxaban, in addition to 315 patients treated with standard therapy. The observational cohorts showed a similar risk of death in DOAC and standard therapy arms (RR 2.12, 95% CI 0.29 to 15.59). New ICH was reported in 2 (0.7%) DOAC-treated patients and recurrent CVT occurred in 4 (1.5%). A favourable mRS between 0 and 2 was reported in 94% of DOAC-treated patients, more likely than standard therapy in observational cohorts (RR 1.13, 95% CI 1.02 to 1.25).
The evidence for DOAC use in CVT is limited although suggests sufficient safety and efficacy despite variability in timing and dose of treatment. This systematic review highlights that further rigorous trials are needed to validate these findings and to determine optimal treatment regimens.
Women have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.
In an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.
This scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.
The scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.
Research ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.
The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.
The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive–behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.
The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.
An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.
The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.
ISRCTN20161479, CTRI/2020/12/030134; Pre-results.
Despite treatment availability, chronic hepatitis C virus (HCV) public health burden is rising in India due to lack of timely diagnosis. Therefore, we aim to assess incremental cost per quality-adjusted life year (QALY) for one-time universal screening followed by treatment of people infected with HCV as compared with a no screening policy in Punjab, India.
Decision tree integrated with Markov model was developed to simulate disease progression. A societal perspective and a 3% annual discount rate were considered to assess incremental cost per QALY gained. In addition, budgetary impact was also assessed with a payer’s perspective and time horizon of 5 years.
Screening services were assumed to be delivered as a facility-based intervention where active screening for HCV cases would be performed at 22 district hospitals in the state of Punjab, which will act as integrated testing as well as treatment sites for HCV.
Two intervention scenarios were compared with no universal screening and treatment (routine care). Scenario I—screening with ELISA followed by confirmatory HCV-RNA quantification and treatment. Scenario II—screening with rapid diagnostic test (RDT) kit followed by confirmatory HCV-RNA quantification and treatment.
Lifetime costs; life years and QALY gained; and incremental cost-effectiveness ratio for each of the above-mentioned intervention scenario as compared with the routine care.
Screening with ELISA and RDT, respectively, results in a gain of 0.028 (0.008 to 0.06) and 0.027 (0.008 to 0.061) QALY per person with costs decreased by –1810 Indian rupees (–3376 to –867) and –1812 Indian rupees (–3468 to –850) when compared with no screening. One-time universal screening of all those ≥18 years at a base coverage of 30%, with ELISA and RDT, would cost 8.5 and 8.3 times more, respectively, when compared with screening the age group of the cohort 40–45 years old.
One-time universal screening followed by HCV treatment is a dominant strategy as compared with no screening. However, budget impact of screening of all ≥18-year-old people seems unsustainable. Thus, in view of findings from both cost-effectiveness and budget impact, we recommend beginning with screening the age cohort with RDT around mean age of disease presentation, that is, 40–45 years, instead of all ≥18-year-old people.