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Delayed QT Prolongation: Derivation of a Novel Risk Factor for Adverse Cardiovascular Events from Acute Drug Overdose

Shastry, Siri; Aluise, Eleanor R; Richardson, Lynne D; Vedanthan, Rajesh; Manini, Alex F
INTRODUCTION:In ED patients with acute drug overdose involving prescription medication and/or substances of abuse, severe QTc prolongation (> 500 ms) is predictive of adverse cardiovascular events (ACVE), defined as myocardial injury, ventricular dysrhythmia, shock, or cardiac arrest. However, it is unclear whether delayed severe QTc prolongation (dsQTp) is a risk factor for ACVE and if specific clinical factors are associated with occurrence of dsQTp. METHODS:A secondary analysis of a prospective cohort of consecutive adult ED patients with acute drug overdose was performed on patients with initial QTc < 500 ms. The predictor variable, dsQTp, was defined as initial QTc < 500 ms followed by repeat QTc ≥ 500 ms. The primary outcome was occurrence of ACVE. Multivariable logistic regression was performed to test whether dsQTp was an independent predictor of ACVE and to derive clinical factors associated with dsQTp. RESULTS:Of 2311 patients screened, 1648 patients were included. The dsQTp group (N = 27) was older than the control group (N = 1621) (51.6 vs 40.2, p < 0.001) and had a higher number of drug exposures (2.92 vs 2.16, p = 0.003). Following adjustment for age, sex, race/ethnicity, number of exposures, serum potassium, and opioid exposure, dsQTp remained an independent predictor of ACVE (aOR: 12.44, p < 0.0001). Clinical factors associated with dsQTp were age > 45 years and polydrug (≥ 3) overdoses. CONCLUSION:In this large secondary analysis of ED patients with acute drug overdose, dsQTp was an independent risk factor for in-hospital occurrence of ACVE.
PMID: 34449039
ISSN: 1937-6995
CID: 5011202

Human-centered implementation research: a new approach to develop and evaluate implementation strategies for strengthening referral networks for hypertension in western Kenya

Pillsbury, Mc Kinsey M; Mwangi, Eunice; Andesia, Josephine; Njuguna, Benson; Bloomfield, Gerald S; Chepchumba, Agneta; Kamano, Jemima; Mercer, Tim; Miheso, Juliet; Pastakia, Sonak D; Pathak, Shravani; Thakkar, Aarti; Naanyu, Violet; Akwanalo, Constantine; Vedanthan, Rajesh
BACKGROUND:Human-centered design (HCD) is an increasingly recognized approach for engaging stakeholders and developing contextually appropriate health interventions. As a component of the ongoing STRENGTHS study (Strengthening Referral Networks for Management of Hypertension Across the Health System), we report on the process and outcomes of utilizing HCD to develop the implementation strategy prior to a cluster-randomized controlled trial. METHODS:We organized a design team of 15 local stakeholders to participate in an HCD process to develop implementation strategies. We tested prototypes for acceptability, appropriateness, and feasibility through focus group discussions (FGDs) with various community stakeholder groups and a pilot study among patients with hypertension. FGD transcripts underwent content analysis, and pilot study data were analyzed for referral completion and reported barriers to referral. Based on this community feedback, the design team iteratively updated the implementation strategy. During each round of updates, the design team reflected on their experience through FGDs and a Likert-scale survey. RESULTS:The design team developed an implementation strategy consisting of a combined peer navigator and a health information technology (HIT) package. Overall, community participants felt that the strategy was acceptable, appropriate, and feasible. During the pilot study, 93% of referrals were completed. FGD participants felt that the implementation strategy facilitated referral completion through active peer engagement; enhanced communication between clinicians, patients, and health administrators; and integrated referral data into clinical records. Challenges included referral barriers that were not directly addressed by the strategy (e.g. transportation costs) and implementation of the HIT package across multiple health record systems. The design team reflected that all members contributed significantly to the design process, but emphasized the need for more transparency in how input from study investigators was incorporated into design team discussions. CONCLUSIONS:The adaptive process of co-creation, prototyping, community feedback, and iterative redesign aligned our implementation strategy with community stakeholder priorities. We propose a new framework of human-centered implementation research that promotes collaboration between community stakeholders, study investigators, and the design team to develop, implement, and evaluate HCD products for implementation research. Our experience provides a feasible and replicable approach for implementation research in other settings. TRIAL REGISTRATION/, NCT02501746 , registration date: July 17, 2015.
PMID: 34479556
ISSN: 1472-6963
CID: 5011342

Egocentric social network characteristics and cardiovascular risk among patients with hypertension or diabetes in western Kenya: a cross-sectional analysis from the BIGPIC trial

Ruchman, Samuel G; Delong, Allison K; Kamano, Jemima H; Bloomfield, Gerald S; Chrysanthopoulou, Stavroula A; Fuster, Valentin; Horowitz, Carol R; Kiptoo, Peninah; Matelong, Winnie; Mugo, Richard; Naanyu, Violet; Orango, Vitalis; Pastakia, Sonak D; Valente, Thomas W; Hogan, Joseph W; Vedanthan, Rajesh
OBJECTIVES:Management of cardiovascular disease (CVD) is an urgent challenge in low-income and middle-income countries, and interventions may require appraisal of patients' social networks to guide implementation. The purpose of this study is to determine whether egocentric social network characteristics (SNCs) of patients with chronic disease in western Kenya are associated with overall CVD risk and individual CVD risk factors. DESIGN:Cross-sectional analysis of enrollment data (2017-2018) from the Bridging Income Generation with GrouP Integrated Care trial. Non-overlapping trust-only, health advice-only and multiplex (trust and health advice) egocentric social networks were elicited for each participant, and SNCs representing social cohesion were calculated. SETTING:24 communities across four counties in western Kenya. PARTICIPANTS:Participants (n=2890) were ≥35 years old with diabetes (fasting glucose ≥7 mmol/L) or hypertension. PRIMARY AND SECONDARY OUTCOMES:We hypothesised that SNCs would be associated with CVD risk status (QRISK3 score). Secondary outcomes were individual CVD risk factors. RESULTS:Among the 2890 participants, 2020 (70%) were women, and mean (SD) age was 60.7 (12.1) years. Forty-four per cent of participants had elevated QRISK3 score (≥10%). No relationship was observed between QRISK3 level and SNCs. In unadjusted comparisons, participants with any individuals in their trust network were more likely to report a good than a poor diet (41% vs 21%). SNCs for the trust and multiplex networks accounted for a substantial fraction of variation in measures of dietary quality and physical activity (statistically significant via likelihood ratio test, adjusted for false discovery rate). CONCLUSION:SNCs indicative of social cohesion appear to be associated with individual behavioural CVD risk factors, although not with overall CVD risk score. Understanding how SNCs of patients with chronic diseases relate to modifiable CVD risk factors could help inform network-based interventions. TRIAL REGISTRATION identifier: NCT02501746;
PMID: 34475172
ISSN: 2044-6055
CID: 5011302

In Response: Don't Throw the Sodium Bicarbonate Out with the Correlation [Letter]

Shastry, Siri; Ellis, Judson; Loo, George; Vedanthan, Rajesh; Richardson, Lynne D; Manini, Alex F
PMID: 33886089
ISSN: 1937-6995
CID: 4847322

Sex differences in health status, healthcare utilization, and costs among individuals with elevated blood pressure: the LARK study from Western Kenya

Sikka, Neha; DeLong, Allison; Kamano, Jemima; Kimaiyo, Sylvester; Orango, Vitalis; Andesia, Josephine; Fuster, Valentin; Hogan, Joseph; Vedanthan, Rajesh
BACKGROUND:Elevated blood pressure is the leading risk factor for global mortality. While it is known that there exist differences between men and women with respect to socioeconomic status, self-reported health, and healthcare utilization, there are few published studies from Africa. This study therefore aims to characterize differences in self-reported health status, healthcare utilization, and costs between men and women with elevated blood pressure in Kenya. METHODS:Data from 1447 participants enrolled in the LARK Hypertension study in western Kenya were analyzed. Latent class analysis based on five dependent variables was performed to describe patterns of healthcare utilization and costs in the study population. Regression analysis was then performed to describe the relationship between different demographics and each outcome. RESULTS:Women in our study had higher rates of unemployment (28% vs 12%), were more likely to report lower monthly earnings (72% vs 51%), and had more outpatient visits (39% vs 28%) and pharmacy prescriptions (42% vs 30%). Women were also more likely to report lower quality-of-life and functional health status, including pain, mobility, self-care, and ability to perform usual activities. Three patterns of healthcare utilization were described: (1) individuals with low healthcare utilization, (2) individuals who utilized care and paid high out-of-pocket costs, and (3) individuals who utilized care but had lower out-of-pocket costs. Women and those with health insurance were more likely to be in the high-cost utilizer group. CONCLUSIONS:Men and women with elevated blood pressure in Kenya have different health care utilization behaviors, cost and economic burdens, and self-perceived health status. Awareness of these sex differences can help inform targeted interventions in these populations.
PMID: 34011345
ISSN: 1471-2458
CID: 4877342

Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial

Genberg, Becky L; Wachira, Juddy; Steingrimsson, Jon A; Pastakia, Sonak; Tran, Dan N Tina; Said, Jamil AbdulKadir; Braitstein, Paula; Hogan, Joseph W; Vedanthan, Rajesh; Goodrich, Suzanne; Kafu, Catherine; Wilson-Barthes, Marta; Galárraga, Omar
INTRODUCTION/BACKGROUND:In Kenya, distance to health facilities, inefficient vertical care delivery and limited financial means are barriers to retention in HIV care. Furthermore, the increasing burden of non-communicable diseases (NCDs) among people living with HIV complicates chronic disease treatment and strains traditional care delivery models. Potential strategies for improving HIV/NCD treatment outcomes are differentiated care, community-based care and microfinance (MF). METHODS AND ANALYSIS/UNASSIGNED:We will use a cluster randomised trial to evaluate integrated community-based (ICB) care incorporated into MF groups in medium and high HIV prevalence areas in western Kenya. We will conduct baseline assessments with n=900 HIV positive members of 40 existing MF groups. Group clusters will be randomised to receive either (1) ICB or (2) standard of care (SOC). The ICB intervention will include: (1) clinical care visits during MF group meetings inclusive of medical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications, and point-of-care laboratory testing; (2) peer support for ART adherence and (3) facility referrals as needed. MF groups randomised to SOC will receive regularly scheduled care at a health facility. Findings from the two trial arms will be compared with follow-up data from n=300 matched controls. The primary outcome will be VS at 18 months. Secondary outcomes will be retention in care, absolute mean change in systolic blood pressure and absolute mean change in HbA1c level at 18 months. We will use mediation analysis to evaluate mechanisms through which MF and ICB care impact outcomes and analyse incremental cost-effectiveness of the intervention in terms of cost per HIV suppressed person-time, cost per patient retained in care and cost per disability-adjusted life-year saved. ETHICS AND DISSEMINATION/UNASSIGNED:The Moi University Institutional Research and Ethics Committee approved this study (IREC#0003054). We will share data via the Brown University Digital Repository and disseminate findings via publication. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT04417127.
PMID: 34006540
ISSN: 2044-6055
CID: 4877112

Supply-chain strategies for essential medicines in rural western Kenya during COVID-19

Tran, Dan N; Were, Phelix M; Kangogo, Kibet; Amisi, James A; Manji, Imran; Pastakia, Sonak D; Vedanthan, Rajesh
Problem/UNASSIGNED:The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide and threatened the supply of essential medicines. Especially affected are vulnerable patients in low- and middle-income countries who can only afford access to public health systems. Approach/UNASSIGNED:Soon after physical distancing and curfew orders began on 15 March 2020 in Kenya, we rapidly implemented three supply-chain strategies to ensure a continuous supply of essential medicines while minimizing patients' COVID-19 exposure risks. We redistributed central stocks of medicines to peripheral health facilities to ensure local availability for several months. We equipped smaller, remote health facilities with medicine tackle boxes. We also made deliveries of medicines to patients with difficulty reaching facilities. Local setting/UNASSIGNED:Τo implement these strategies we leveraged our 30-year partnership with local health authorities in rural western Kenya and the existing revolving fund pharmacy scheme serving 85 peripheral health centres. Relevant changes/UNASSIGNED:In April 2020, stocks of essential chronic and non-chronic disease medicines redistributed to peripheral health facilities increased to 835 140 units, as compared with 316 330 units in April 2019. We provided medicine tackle boxes to an additional 46 health facilities. Our team successfully delivered medications to 264 out of 311 patients (84.9%) with noncommunicable diseases whom we were able to reach. Lessons learnt/UNASSIGNED:Our revolving fund pharmacy model has ensured that patients' access to essential medicines has not been interrupted during the pandemic. Success was built on a community approach to extend pharmaceutical services, adapting our current supply-chain infrastructure and working quickly in partnership with local health authorities.
PMID: 33958827
ISSN: 1564-0604
CID: 4866752

Maintaining care delivery for non-communicable diseases in the face of the COVID-19 pandemic in western Kenya

Kamano, Jemima; Naanyu, Violet; Ayah, Richard; Limo, Obed; Gathecha, Gladwell; Saenyi, Eugene; Jefwa, Pendo; Too, Kenneth; Manji, Imran; Gala, Pooja; Vedanthan, Rajesh
The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide, gravely threatening continuity of care for noncommunicable diseases (NCDs), particularly in low-resource settings. We describe our efforts to maintain the continuity of care for patients with NCDs in rural western Kenya during the COVID-19 pandemic, using a five-component approach: 1) Protect: protect staff and patients; 2) Preserve: ensure medication availability and clinical services; 3) Promote: conduct health education and screenings for NCDs and COVID-19; 4) Process: collect process indicators and implement iterative quality improvement; and 5) Plan: plan for the future and ensure financial risk protection in the face of a potentially overwhelming health and economic catastrophe. As the pandemic continues to evolve, we must continue to pursue new avenues for improvement and expansion. We anticipate continuing to learn from the evolving local context and our global partners as we proceed with our efforts.
ISSN: 1937-8688
CID: 5007902

Is spurious penicillin allergy a major public health concern only in high-income countries?

Krishna, Mamidipudi Thirumala; Vedanthan, Pudupakkam K; Vedanthan, Rajesh; El Shabrawy, Reham Mohamed; Madhan, Ramesh; Nguyen, Hoa L; Kudagammana, Thushara; Williams, Iestyn; Karmacharya, Biraj; Hariharan, Seetharaman; Krishnamurthy, Kandamaran; Sumantri, Stevent; Elliott, Rachel; Mahesh, Padukudru Anand; Marriott, John F
PMID: 34016579
ISSN: 2059-7908
CID: 4877612

Group Medical Visit and Microfinance Intervention for Patients With Diabetes or Hypertension in Kenya

Vedanthan, Rajesh; Kamano, Jemima H; Chrysanthopoulou, Stavroula A; Mugo, Richard; Andama, Benjamin; Bloomfield, Gerald S; Chesoli, Cleophas W; DeLong, Allison K; Edelman, David; Finkelstein, Eric A; Horowitz, Carol R; Manyara, Simon; Menya, Diana; Naanyu, Violet; Orango, Vitalis; Pastakia, Sonak D; Valente, Thomas W; Hogan, Joseph W; Fuster, Valentin
BACKGROUND:Incorporating social determinants of health into care delivery for chronic diseases is a priority. OBJECTIVES/OBJECTIVE:The goal of this study was to evaluate the impact of group medical visits and/or microfinance on blood pressure reduction. METHODS:The authors conducted a cluster randomized trial with 4 arms and 24 clusters: 1) usual care (UC); 2) usual care plus microfinance (MF); 3) group medical visits (GMVs); and 4) GMV integrated into MF (GMV-MF). The primary outcome was 1-year change in systolic blood pressure (SBP). Mixed-effects intention-to-treat models were used to evaluate the outcomes. RESULTS:A total of 2,890 individuals (69.9% women) were enrolled (708 UC, 709 MF, 740 GMV, and 733 GMV-MF). Average baseline SBP was 157.5 mm Hg. Mean SBP declined -11.4, -14.8, -14.7, and -16.4 mm Hg in UC, MF, GMV, and GMV-MF, respectively. Adjusted estimates and multiplicity-adjusted 98.3% confidence intervals showed that, relative to UC, SBP reduction was 3.9 mm Hg (-8.5 to 0.7), 3.3 mm Hg (-7.8 to 1.2), and 2.3 mm Hg (-7.0 to 2.4) greater in GMV-MF, GMV, and MF, respectively. GMV and GMV-MF tended to benefit women, and MF and GMV-MF tended to benefit poorer individuals. Active participation in GMV-MF was associated with greater benefit. CONCLUSIONS:A strategy combining GMV and MF for individuals with diabetes or hypertension in Kenya led to clinically meaningful SBP reductions associated with cardiovascular benefit. Although the significance threshold was not met in pairwise comparison hypothesis testing, confidence intervals for GMV-MF were consistent with impacts ranging from substantive benefit to neutral effect relative to UC. Incorporating social determinants of health into care delivery for chronic diseases has potential to improve outcomes. (Bridging Income Generation With Group Integrated Care [BIGPIC]; NCT02501746).
PMID: 33888251
ISSN: 1558-3597
CID: 4847432