Showing papers by "Anushka Patel published in 2021"

An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: protocol for the SMART Mental Health programme.

Abstract: Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75–95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived—a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. The primary study outcome is the difference in mean behaviour scores at 12 months in the combined ‘high-risk’ and ‘non-high-risk’ cohort and the mean difference in PHQ-9 scores at 12 months in the ‘high-risk’ cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. Clinical Trial Registry India CTRI/2018/08/015355 . Registered on 16 August 2018.

SMART Mental Health Project: process evaluation to understand the barriers and facilitators for implementation of multifaceted intervention in rural India

Abstract: Globally, mental health problems are a growing public health concern Resources and services for mental disorders are disproportionately low compared to disease burden In order to bridge treatment gaps, The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Project was implemented across 12 villages in West Godavari district of the southern Indian state of Andhra Pradesh This paper reports findings from a process evaluation of feasibility and acceptability of the intervention that focused on a mental health services delivery model to screen, diagnose and manage common mental disorders (CMDs) A mixed methods evaluation was undertaken using quantitative service usage analytics, and qualitative data from in-depth interviews and focus group discussions were conducted with stakeholders including primary care physicians, community health workers, field staff and community members Barriers to and facilitators of intervention implementation were identified Andersen’s Behavioral Model for Health Services Use was the conceptual framework used to guide the process evaluation and interpretation of data In all, 41 Accredited Social Health Activists (ASHAs) and 6 primary health centre (PHC) doctors were trained in mental health symptoms and its management ASHAs followed up 987% of screen positive cases, and 812% of these were clinically diagnosed and treated by the PHC doctors The key facilitators of implementation were adequate training and supervision of field staff, ASHAs and doctors, use of electronic decision support, incorporation of a door-to-door campaign and use of culturally tailored dramas/videos to raise awareness about CMDs, and organising health camps at the village level facilitating delivery of intervention activities Barriers to implementation included travel distance to receive care, limited knowledge about mental health, high level of stigma related to mental health issues, and poor mobile network signals and connectivity in the villages Lack of familiarity with and access to mobile phones, especially among women, to accessing health related messages as part of the intervention The evaluation not only provides a context to the interventions delivered, but also allowed an understanding of possible factors that need to be addressed to make the programme scalable and of benefit to policy makers

Heart Failure Therapies for the Prevention of HER2-Monoclonal Antibody-Mediated Cardiotoxicity: A Systematic Review and Meta-Analysis of Randomized Trials.

Abstract: Monoclonal antibodies including trastuzumab, pertuzumab, and antibody-drug conjugates, form the backbone of HER2-positive breast cancer therapy. Unfortunately, an important adverse effect of these agents is cardiotoxicity, occurring in approximately 10% of patients. There is increasing published data regarding prevention strategies for cardiotoxicity, though seldom used in clinical practice. We performed a systematic review and meta-analysis of randomized-controlled trials to evaluate pharmacotherapy for the prevention of monoclonal HER2-directed antibody-induced cardiotoxicity in patients with breast cancer. Online databases were queried from their inception until October 2021. Effects were determined by calculating risk ratios (RRs) and 95% confidence intervals (CI) or mean differences (MD) using random-effects models. We identified five eligible trials. In the three trials (n = 952) reporting data on the primary outcome of cardiotoxicity, there was no clear effect for patients assigned active treatment compared to control (RR = 0.90, 95% CI 0.63 to 1.29, p = 0.57). Effects were similar for ACE-I/ARB and beta-blockers (p homogeneity = 0.50). Active treatment reduced the risk of HER2 therapy interruptions (RR = 0.57, 95% CI 0.43 to 0.77, p < 0.001) with similar findings for ACE-I/ARB and beta-blockers (p homogeneity = 0.97). Prophylactic treatment with ACE-I/ARB or beta-blocker therapy may be of value for cardio-protection in patients with breast cancer prescribed monoclonal antibodies. Further, adequately powered randomized trials are required to define the role of routine prophylactic treatment in this patient group.

Cost-effectiveness of a mobile technology-enabled primary care intervention for cardiovascular disease risk management in rural Indonesia.

Abstract: Cardiovascular diseases (CVD) are the leading cause of death in Indonesia, and there are large disparities in access to recommended preventative treatments across the country, particularly in rural areas. Technology-enabled screening and management led by community health workers have been shown to be effective in better managing those at high risk of CVD in a rural Indonesian population; however, the economic impacts of implementing such an intervention are unknown. We conducted a modelled cost-effectiveness analysis of the SMARThealth intervention in rural villages of Malang district, Indonesia from the payer perspective over a 10-year period. A Markov model was designed and populated with epidemiological and cost data collected in a recent quasi-randomized trial, with nine health states representing a differing risk for experiencing a major CVD event. Disability-Adjusted Life Years (DALYs) were estimated for the intervention and usual care using disability weights from the literature for major CVD events. Annual treatment costs for CVD treatment and prevention were $US83 under current care and $US144 for those receiving the intervention. The intervention had an incremental cost-effectiveness ratio of $4288 per DALY averted and $3681 per major CVD event avoided relative to usual care. One-way and probabilistic sensitivity analyses demonstrated that the results were robust to plausible variations in model parameters and that the intervention is highly likely to be considered cost-effective by decision-makers across a range of potentially acceptable willingness to pay levels. Relative to current care, the intervention was a cost-effective means to improve the management of CVD in this rural Indonesian population. Further scale-up of the intervention offers the prospect of significant gains in population health and sustainable progress toward universal health coverage for the Indonesian population.

Polypills — A Central Strategy for Improving Cardiovascular Health

Abstract: The polypill concept garnered substantial attention in 2003 after the publication of a modeling analysis that proposed that the use of fixed-dose combination therapy in persons with established ath...

An electronic decision support-based complex intervention to improve management of cardiovascular risk in primary health care: a cluster randomised trial (INTEGRATE)

Abstract: Objectives To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. Design, setting Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 - 13 September 2019. Participants General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. Intervention Electronic point-of-care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy-based medication adherence program. Main outcome measures Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low-density lipoprotein (LDL) cholesterol goals at study end. Results After a median 15 months' follow-up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85-1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). Conclusions Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616000233426 (prospective).

Why do strategies to strengthen primary health care succeed in some places and fail in others? Exploring local variation in the effectiveness of a community health worker managed digital health intervention in rural India.

Abstract: INTRODUCTION Digital health interventions (DHIs) have huge potential as support modalities to identify and manage cardiovascular disease (CVD) risk in resource-constrained settings, but studies assessing them show modest effects. This study aims to identify variation in outcomes and implementation of SMARTHealth India, a cluster randomised trial of an ASHA-managed digitally enabled primary healthcare (PHC) service strengthening strategy for CVD risk management, and to explain how and in what contexts the intervention was effective. METHODS We analysed trial outcome and implementation data for 18 PHC centres and collected qualitative data via focus groups with ASHAs (n=14) and interviews with ASHAs, PHC facility doctors and fieldteam mangers (n=12) Drawing on principles of realist evaluation and an explanatory mixed-methods design we developed mechanism-based explanations for observed outcomes. RESULTS There was substantial between-cluster variation in the primary outcome (overall: I2=62.4%, p<=0.001). The observed heterogeneity in trial outcomes was not attributable to any single factor. Key mechanisms for intervention effectiveness were community trust and acceptability of doctors' and ASHAs' new roles, and risk awareness. Enabling local contexts were seen to evolve over time and in response to the intervention. These included obtaining legitimacy for ASHAs' new roles from trusted providers of curative care; ASHAs' connections to community and to qualified providers; their responsiveness to community needs; and the accessibility, quality and appropriateness of care provided by higher level medical providers, including those outside of the implementing (public) subsystem. CONCLUSION Local contextual factors were significant influences on the effectiveness of this DHI-enabled PHC service strategy intervention. Local adaptions need to be planned for, monitored and responded to over time. By identifying plausible explanations for variation in outcomes between clusters, we identify potential strategies to strengthen such interventions.

Chronic kidney disease and the outcomes of fibrinolysis for ST-segment elevation myocardial infarction: A real-world study.

Abstract: Background In low-resource regions, fibrinolytic therapy is often the only option for ST-elevation myocardial infarction (STEMI) patients as primary percutaneous coronary intervention (PCI) is often not available and patients are hardly transferred to a medical center with PCI capacity within the first 120 minutes. Chronic kidney disease (CKD) is one of the most frequently encountered complications of STEMI. However, the evidence for the efficacy of fibrinolytic therapy in STEMI patients with CKD is still limited. The aim of this study is to test whether CKD modifies the association between fibrinolytic therapy and short-term major adverse cardiovascular events (MACEs) among patients with STEMI. Methods and findings This is a real-world study analyzing the data from 9508 STEMI patients (mean age: 64.0±12.4 years; male: 70.1%) in the third phase of Clinical Pathways in Acute Coronary Syndromes program (CPACS-3), which is a large study of the management of acute coronary syndromes (ACS) in 101 county hospitals without PCI capacity in China. CKD was defined as an estimated glomerular filtration rate of less than 60 mL/min per 1·73 m2 at the admission. The primary outcome is short-term MACEs, including all-cause death, recurrent myocardial infarction, or nonfatal stroke. Patients were recruited consecutively between October 2011 and November 2014. Out of them, 1282 patients (13.5%) were classified as having CKD. Compared with non-CKD patients, CKD patients were less likely to receive fibrinolytic therapy than non-CKD patients (26.4% vs. 38.9%, P<0.001), more likely to experience a failed fibrinolytic therapy (32.8% vs. 16.9%), and had a higher risk of short-term MACEs (19.7% vs. 5.6%). After full adjustment, use of fibrinolytic therapy was associated with a significantly lower risk of short-term MACEs in non-CKD patients (relative risk [RR] = 0.87, 95% confidence interval [CI]: 0.76–0.99), but not in CKD patients (P for interaction = 0.026). Further analysis stratified by the success of fibrinolysis showed that compared with patients who did not receive fibrinolytic therapy, patients with successful fibrinolysis had a lower risk of short-term MACEs that was similar between patients with (RR = 0.71, 95% CI: 0.55–0.82) and without CKD (RR = 0.67, 95% CI: 0.55–0.92), while patients with unsuccessful fibrinolysis had a similarly higher risk in CKD patients (RR = 1.25, 95% CI: 1.09–1.43) and non-CKD patients (RR = 1.30, 95% CI: 1.13–1.50). Conclusions CKD reduced the likelihood of successful fibrinolysis and increased the risk of short-term MACEs in patients with STEMI. Attention should be paid to how to improve the success rate of fibrinolytic therapy for STEMI patients with CKD. Trial registration The CPACS-3 study was registered on www.clinicaltrials.gov (NCT01398228).

Interventions to prevent or delay the onset of type 2 diabetes in women with prior gestational diabetes mellitus: protocol for a living systematic review and prospective meta-analysis

Abstract: Introduction Gestational diabetes mellitus (GDM), once considered a transient condition during pregnancy, is now a firmly established risk factor for type 2 diabetes mellitus (T2DM). Women whose blood glucose levels do not return to normal soon after giving birth are particularly at high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions are recommended for women with GDM to prevent or delay the subsequent development of T2DM. Recent systematic reviews and meta-analyses have suggested postpartum lifestyle interventions may be beneficial in reducing the risk of developing diabetes in women with GDM, however, included studies were generally small, many had a high risk of bias and subsequent data have become available with new trials likely to complete in the next couple of years. In addition, to the best of our knowledge, formal systematic review and meta-analysis of other approaches to preventing diabetes in this population (e.g. pharmacotherapy) has not been attempted. Therefore, an updated systematic review is needed and will be formulated as a living systematic review to ensure the inclusion of emerging studies. Methods and analysis A living systematic review and a prospective meta-analysis to examine the effectiveness of postpartum interventions in reducing the risk of developing T2DM in women with recent GDM. Ethics and dissemination Ethics committee approval is not required. The data included will be from published studies, and a continued living systematic review and prospective meta-analysis will occur once a year for the next five years. Results of the review will be disseminated at relevant meetings. PROSPERO registration number CRD42021279891 Strengths and limitations of this study A living systematic review will allow continuous surveillance of emerging literature on different lifestyle interventions in women with a history of GDM and allow identification of effective strategies for diabetes prevention. We estimate considerable heterogeneity of interventions which may limit our ability to make clear conclusions.

The association between influenza vaccination, all-cause mortality and cardiovascular mortality: a protocol for a living systematic review and prospective meta-analysis

Abstract: IntroductionInfluenza virus infection is known to increase the risk of cardiovascular events, especially in populations with pre-existing cardiovascular disease. Considering that influenza is vaccine preventable, international guidelines recommend high-risk populations with CVD receive an influenza vaccine every year, but there are various classifications of recommendations and levels of evidence. Previous systematic reviews concluded uncertain evidence on influenza vaccine efficacy for preventing cardiovascular events in the general population or in populations with pre-existing CVD. Limited safety data of influenza vaccines were reported for populations with pre-existing CVD. Randomized control trials with larger sample sizes relative to previous studies are emerging, the findings of these trials are likely to be highly influential on summary efficacy estimates. Methods and analysisWe aim to perform a living systematic review and a prospective meta-analysis to evaluate the efficacy and safety of influenza vaccines compared to no vaccines or placebo for preventing mortality or cardiovascular disease events in the general population and in populations with pre-existing CVD. Ethics and disseminationFormal ethical review is not required as this study does not need primary data collection. We will publish results of the living systematic review and prospective meta-analysis in a peer-reviewed journal. Findings will also be presented at relevant meetings. PROSPERO registration numberCRD42021222519. Strengths and limitations of this studyO_LIThe living systematic review will continually incorporate the latest research findings and keep the synthesized information updated. A prospective meta-analysis will better address this evolving evidence. C_LIO_LISafety of influenza vaccines in populations with pre-existing cardiovascular diseases will be studied in particular to complete the current evidence base. C_LIO_LIObservational studies may affect the overall quality of the study results. We will stratify the analysis by study design and present both randomized and non-randomized results. C_LI