Nevin Manimala

PLOS Glob Public Health. 2023 Apr 12;3(4):e0001741. doi: 10.1371/journal.pgph.0001741. eCollection 2023.

ABSTRACT

Healthcare workers (HCWs) have a significant occupational risk of hepatitis B virus (HBV) infection. Vaccination remains the most effective measure recommended to avert the risk. However, there’s limited information on hepatitis B vaccine uptake rates and the seroprotection status of HCWs, especially in sub-Saharan Africa. This study aimed to assess hepatitis B vaccination status and also seroprotection status of HCWs in three selected public hospitals in Kenya. This was a cross-sectional study carried out among HCWs at Kenyatta National Hospital (KNH), Naivasha and Mbagathi County hospitals. Data on participants’ demographics and hepatitis B vaccination status was collected using an interviewer-guided questionnaire. Blood samples were collected and tested for hepatitis B surface antigen (HBsAg), hepatitis B surface antibodies (anti-HBs), and hepatitis B core antibodies (anti-HBc) using Enzyme Linked Immuno Sorbent Assay technique. Data were analyzed using Statistical Package for the Social Sciences (SPSS) and Graph pad prism. Of the 145 eligible HCWs, 120 (82.8%) were vaccinated, with 77 (53.1%) having received the recommended three doses. Three quarters (108/145) of the vaccinated HCWs were seroprotected (titres ≥10 mIU/ml) against HBV infection, while 16.6% were non-responders (titres <10 mIU/ml). Vaccination with more than two doses and HBV exposure were significantly associated with anti-HBs titre levels (P<0.05). HCWs who received less than 2 doses of the vaccine were 70% less likely to have high anti-HBs titre levels (aOR, 0.3; 95% CI, 0.1-0.8; P = 0.013). Nearly all HCWs were vaccinated against hepatitis B virus. The majority of all HCWs were seroprotected against hepatitis B virus but a number of them had an insufficient immunity to the virus despite vaccination or prior exposure. There’s need to sensitize HCWs and enforce mandatory full vaccination as per the recommended vaccination schedule.

PMID:37043440 | DOI:10.1371/journal.pgph.0001741

PLOS Glob Public Health. 2023 Apr 12;3(4):e0001136. doi: 10.1371/journal.pgph.0001136. eCollection 2023.

ABSTRACT

During 2010-2012, extreme food insecurity and famine in Somalia were estimated to account for 256,000 deaths. Since 2014 Somalia has experienced recurrent below-average rainfall, with consecutive failed rains in late 2016 and 2017 leading to large-scale drought, displacement and epidemics. We wished to estimate mortality across Somalia from 2014 to 2018, and measure the excess death toll attributable to the 2017-2018 drought-triggered crisis. We used a statistical approach akin to small-area estimation, and relying solely on existing data. We identified and re-analysed 91 household surveys conducted at the district level and estimating the crude (CDR) and under 5 years death rate (U5DR) over retrospective periods of 3-4 months. We captured datasets of candidate predictors of mortality with availability by district and month. We also reconstructed population denominators by district-month combining alternative census estimates and displacement data. We combined these data inputs into predictive models to estimate CDR and U5DR and combined the predictions with population estimates to project death tolls. Excess mortality was estimated by constructing counterfactual no-crisis scenarios. Between 2013 and 2018, Somalia’s population increased from 12.0 to 13.5 million, and internally displaced people or returnees reached 20% of the population. We estimated an excess death toll of 44,700 in the most likely counterfactual scenario, and as high as 163,800 in a pessimistic scenario. By contrast to 2010-2012, excess deaths were widespread across Somalia, including central and northern regions. This analysis suggests that the 2017-2018 crisis had a lower, albeit still very substantial, mortality impact than its 2010-2012 predecessor. Despite modest elevations in death rate, crisis conditions were widespread and affected a population of millions. Humanitarian response to drought-related crises in Somalia needs to be strengthened, target the most vulnerable and emphasise very early interventions.

PMID:37043439 | DOI:10.1371/journal.pgph.0001136

PLoS One. 2023 Apr 12;18(4):e0282622. doi: 10.1371/journal.pone.0282622. eCollection 2023.

ABSTRACT

IMPORTANCE: Sleep is critical to a person’s physical and mental health, but there are few studies systematically assessing risk factors for sleep disorders.

OBJECTIVE: The objective of this study was to identify risk factors for a sleep disorder through machine-learning and assess this methodology.

DESIGN, SETTING, AND PARTICIPANTS: A retrospective, cross-sectional cohort study using the publicly available National Health and Nutrition Examination Survey (NHANES) was conducted in patients who completed the demographic, dietary, exercise, and mental health questionnaire and had laboratory and physical exam data.

METHODS: A physician diagnosis of insomnia was the outcome of this study. Univariate logistic models, with insomnia as the outcome, were used to identify covariates that were associated with insomnia. Covariates that had a p<0.0001 on univariate analysis were included within the final machine-learning model. The machine learning model XGBoost was used due to its prevalence within the literature as well as its increased predictive accuracy in healthcare prediction. Model covariates were ranked according to the cover statistic to identify risk factors for insomnia. Shapely Additive Explanations (SHAP) were utilized to visualize the relationship between these potential risk factors and insomnia.

RESULTS: Of the 7,929 patients that met the inclusion criteria in this study, 4,055 (51% were female, 3,874 (49%) were male. The mean age was 49.2 (SD = 18.4), with 2,885 (36%) White patients, 2,144 (27%) Black patients, 1,639 (21%) Hispanic patients, and 1,261 (16%) patients of another race. The machine learning model had 64 out of a total of 684 features that were found to be significant on univariate analysis (P<0.0001 used). These were fitted into the XGBoost model and an AUROC = 0.87, Sensitivity = 0.77, Specificity = 0.77 were observed. The top four highest ranked features by cover, a measure of the percentage contribution of the covariate to the overall model prediction, were the Patient Health Questionnaire depression survey (PHQ-9) (Cover = 31.1%), age (Cover = 7.54%), physician recommendation of exercise (Cover = 3.86%), weight (Cover = 2.99%), and waist circumference (Cover = 2.70%).

CONCLUSION: Machine learning models can effectively predict risk for a sleep disorder using demographic, laboratory, physical exam, and lifestyle covariates and identify key risk factors.

PMID:37043435 | DOI:10.1371/journal.pone.0282622

Ann Med. 2023 Dec;55(1):2198255. doi: 10.1080/07853890.2023.2198255.

ABSTRACT

Background: The Environmental Determinants of Islet Autoimmunity (ENDIA) pregnancy-birth cohort investigates the developmental origins of type 1 diabetes (T1D), with recruitment between 2013 and 2019. ENDIA is the first study in the world with comprehensive data and biospecimen collection during pregnancy, at birth and through childhood from at-risk children who have a first-degree relative with T1D. Environmental exposures are thought to drive the progression to clinical T1D, with pancreatic islet autoimmunity (IA) developing in genetically susceptible individuals. The exposures and key molecular mechanisms driving this progression are unknown. Persistent IA is the primary outcome of ENDIA; defined as a positive antibody for at least one of IAA, GAD, ZnT8 or IA2 on two consecutive occasions and signifies high risk of clinical T1D.Method: A nested case-control (NCC) study design with 54 cases and 161 matched controls aims to investigate associations between persistent IA and longitudinal omics exposures in ENDIA. The NCC study will analyse samples obtained from ENDIA children who have either developed persistent IA or progressed to clinical T1D (cases) and matched control children at risk of developing persistent IA. Control children were matched on sex and age, with all four autoantibodies absent within a defined window of the case’s onset date. Cases seroconverted at a median of 1.37 years (IQR 0.95, 2.56). Longitudinal omics data generated from approximately 16,000 samples of different biospecimen types, will enable evaluation of changes from pregnancy through childhood.Conclusions: This paper describes the ENDIA NCC study, omics platform design considerations and planned univariate and multivariate analyses for its longitudinal data. Methodologies for multivariate omics analysis with longitudinal data are discovery-focused and data driven. There is currently no single multivariate method tailored specifically for the longitudinal omics data that the ENDIA NCC study will generate and therefore omics analysis results will require either cross validation or independent validation.KEY MESSAGESThe ENDIA nested case-control study will utilize longitudinal omics data on approximately 16,000 samples from 190 unique children at risk of type 1 diabetes (T1D), including 54 who have developed islet autoimmunity (IA), followed during pregnancy, at birth and during early childhood, enabling the developmental origins of T1D to be explored.

PMID:37043275 | DOI:10.1080/07853890.2023.2198255

J Med Internet Res. 2023 Apr 12;25:e42455. doi: 10.2196/42455.

ABSTRACT

BACKGROUND: Cardiovascular diseases (CVDs) cause most deaths globally and can reduce quality of life (QoL) of rehabilitees with cardiac disease. The risk factors of CVDs are physical inactivity and increased BMI. With physical activity, it is possible to prevent CVDs, improve QoL, and help maintain a healthy body mass. Current literature shows the possibilities of digitalization and advanced technology in supporting independent self-rehabilitation. However, the interpretation of the results is complicated owing to the studies’ high heterogeneity. In addition, the added value of this technology has not been studied well, especially in cardiac rehabilitation.

OBJECTIVE: We aimed to examine the effectiveness of added remote technology in cardiac rehabilitation on physical function, anthropometrics, and QoL in rehabilitees with CVD compared with conventional rehabilitation.

METHODS: Rehabilitees were cluster randomized into 3 remote technology intervention groups (n=29) and 3 reference groups (n=30). The reference group received conventional cardiac rehabilitation, and the remote technology intervention group received conventional cardiac rehabilitation with added remote technology, namely, the Movendos mCoach app and Fitbit charge accelerometer. The 12 months of rehabilitation consisted of three 5-day in-rehabilitation periods in the rehabilitation center. Between these periods were two 6-month self-rehabilitation periods. Outcome measurements included the 6-minute walk test, body mass, BMI, waist circumference, and World Health Organization QoL-BREF questionnaire at baseline and at 6 and 12 months. Between-group differences were assessed using 2-tailed t tests and Mann-Whitney U test. Within-group differences were analyzed using a paired samples t test or Wilcoxon signed-rank test.

RESULTS: Overall, 59 rehabilitees aged 41 to 66 years (mean age 60, SD 6 years; n=48, 81% men) were included in the study. Decrement in waist circumference (6 months: 1.6 cm; P=.04; 12 months: 3 cm; P<.001) and increment in self-assessed QoL were greater (environmental factors: 0.5; P=.02) in the remote technology intervention group than the reference group. Both groups achieved statistically significant improvements in the 6-minute walk test in both time frames (P=.01-.03). Additionally, the remote technology intervention group achieved statistically significant changes in the environmental domain at 0-6 months (P=.03) and waist circumference at both time frames (P=.01), and reference group achieve statistically significant changes in waist circumference at 0-6 months (P=.02).

CONCLUSIONS: Remote cardiac rehabilitation added value to conventional cardiac rehabilitation in terms of waist circumference and QoL. The results were clinically small, but the findings suggest that adding remote technology to cardiac rehabilitation may increase beneficial health outcomes. There was some level of systematic error during rehabilitation intervention, and the sample size was relatively small. Therefore, care must be taken when generalizing the study results beyond the target population. To confirm assumptions of the added value of remote technology in rehabilitation interventions, more studies involving different rehabilitees with cardiac disease are required.

TRIAL REGISTRATION: ISRCTN Registry ISRCTN61225589; https://www.isrctn.com/ISRCTN61225589.

PMID:37043264 | DOI:10.2196/42455

JMIR Form Res. 2023 Apr 12;7:e45301. doi: 10.2196/45301.

ABSTRACT

BACKGROUND: Although there is an increasing use of digital adherence technologies (DATs), such as real-time monitors and SMS reminders in tuberculosis medication adherence, suboptimal patient engagement with various DATs has been reported. Additionally, financial constraints can limit DAT’s utility. The perceived usefulness and the design mechanisms of DATs linked to mobile money financial incentives for tuberculosis medication management remain unclear.

OBJECTIVE: The aim of this study is to describe the perceived usefulness and design mechanisms for a DAT intervention called My Mobile Wallet, which is composed of real-time adherence monitors, SMS reminders, and mobile money incentives to support tuberculosis medication adherence in a low-income setting.

METHODS: This study used mixed methods approaches among persons with tuberculosis recruited from the Tuberculosis Clinic in the Mbarara Regional Referral Hospital. We purposively sampled 21 persons with tuberculosis aged 18 years and older, who owned cell phones and were able to use SMS text messaging interventions. We also enrolled 9 participants who used DATs in our previous study. We used focus group discussions with the 30 participants to solicit perceptions about the initial version of the My Mobile Wallet intervention, and then iteratively refined subsequent versions of the intervention following a user-centered design approach until the beta version of the intervention that suited their needs was developed. Surveys eliciting information about participants’ cell phone use and perceptions of the intervention were also administered. Content analysis was used to inductively analyze qualitative data to derive categories describing the perceived usefulness of the intervention, concerns, and design mechanisms. Stata (version 13; StataCorp) was used to analyze survey data.

RESULTS: Participants expressed the perceived usefulness of the My Mobile Wallet intervention in terms of being reminded to take medication, supported with transport to the clinic, and money to meet other tuberculosis medication-related costs, all of which were perceived to imply care, which could create a sense of connectedness to health care workers. This could consequently cause participants to develop a self-perceived need to prove their commitment to adherence to health care workers who care for them, thereby motivating medication adherence. For fear of unintended tuberculosis status disclosure, 20 (67%) participants suggested using SMS language that is confidential-not easily related to tuberculosis. To reduce the possibilities of using the money for other competing demands, 25 (83%) participants preferred sending the money 1-2 days before the appointment to limit the time lag between receiving the money and visiting the clinic.

CONCLUSIONS: DATs complemented with mobile money financial incentives could potentially provide acceptable approaches to remind, support, and motivate patients to adhere to taking their tuberculosis medication.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05656287; https://clinicaltrials.gov/ct2/show/NCT05656287.

PMID:37043263 | DOI:10.2196/45301

JMIR Public Health Surveill. 2023 Apr 12;9:e41261. doi: 10.2196/41261.

ABSTRACT

BACKGROUND: Deliberate self-harm (DSH) along with old age, physical disability, and low socioeconomic status are well-known contributors to suicide-related deaths. In recent years, South Korea has the highest suicide death rate among all Organization for Economic Co-operation and Development countries. Owing to the difficulty of accessing data of individuals with DSH behavior who died by suicide, the factors associated with suicide death in these high-risk individuals have not been sufficiently explored. There have been conflicting findings with regard to the relationship between previous psychiatric visits and suicidal death.

OBJECTIVE: We aimed to address the following 3 questions: Are there considerable differences in demographics, socioeconomic status, and clinical features in individuals who received psychiatric diagnosis (either before DSH or after DSH event) and those who did not? Does receiving a psychiatric diagnosis from the Department of Psychiatry, as opposed to other departments, affect survival? and Which factors related to DSH contribute to deaths by suicide?

METHODS: We used the Korean National Health Insurance Service Database to design a cohort of 5640 individuals (3067/5640, 54.38% women) who visited the hospital for DSH (International Classification of Diseases codes X60-X84) between 2002 and 2020. We analyzed whether there were significant differences among subgroups of individuals with DSH behavior based on psychiatric diagnosis status (whether they had received a psychiatric diagnosis, either before or after the DSH event) and the department from which they had received the psychiatric diagnosis. Another main outcome of the study was death by suicide. Cox regression models yielded hazard ratios (HRs) for suicide risk. Patterns were plotted using Kaplan-Meier survival curves.

RESULTS: There were significant differences in all factors including demographic, health-related, socioeconomic, and survival variables among the groups that were classified according to psychiatric diagnosis status (P<.001). The group that did not receive a psychiatric diagnosis had the lowest survival rate (867/1064, 81.48%). Analysis drawn using different departments from where the individual had received a psychiatric diagnosis showed statistically significant differences in all features of interest (P<.001). The group that had received psychiatric diagnoses from the Department of Psychiatry had the highest survival rate (888/951, 93.4%). These findings were confirmed using the Kaplan-Meier survival curves (P<.001). The severity of DSH (HR 4.31, 95% CI 3.55-5.26) was the most significant contributor to suicide death, followed by psychiatric diagnosis status (HR 1.84, 95% CI 1.47-2.30).

CONCLUSIONS: Receiving psychiatric assessment from a health care professional, especially a psychiatrist, reduces suicide death in individuals who had deliberately harmed themselves before. The key characteristics of individuals with DSH behavior who die by suicide are male sex, middle age, comorbid physical disabilities, and higher socioeconomic status.

PMID:37043262 | DOI:10.2196/41261

JAMA Surg. 2023 Apr 12. doi: 10.1001/jamasurg.2023.0652. Online ahead of print.

ABSTRACT

IMPORTANCE: Each year, the National Cancer Database (NCDB) collects and analyzes data used in reports to support research, quality measures, and Commission on Cancer program accreditation. Because data models used to generate these reports have been historically stable, year-to-year variances have been attributed to changes within the cancer program rather than data modeling. Cancer submissions in 2020 were anticipated to be significantly different from prior years because of the COVID-19 pandemic. This study involved a validation analysis of the variances in observed to expected 2020 NCDB cancer data in comparison with 2019 and 2018.

OBSERVATIONS: The NCDB captured a total of 1 223 221 overall cancer cases in 2020, a decrease of 14.4% (Δ = -206 099) compared with 2019. The early months of the COVID-19 pandemic (March-May 2020) coincided with a nadir of cancer cases in April 2020 that did not recover to overall prepandemic levels through the remainder of 2020. In the early months of the COVID-19 pandemic, the proportion of early-stage disease decreased sharply overall, while the proportion of late-stage disease increased. However, differences in observed to expected stage distribution in 2020 varied by primary disease site. Statistically significant differences in the overall observed to expected proportions of race and ethnicity, sex, insurance type, geographic location, education, and income were identified, but consistent patterns were not evident.

CONCLUSIONS AND RELEVANCE: Historically stable NCDB data models used for research, administrative, and quality improvement purposes were disrupted during the first year of the COVID-19 pandemic. NCDB data users will need to carefully interpret disease- and program-specific findings for years to come to account for pandemic year aberrations when running models that include 2020.

PMID:37043215 | DOI:10.1001/jamasurg.2023.0652

JAMA Netw Open. 2023 Apr 3;6(4):e237699. doi: 10.1001/jamanetworkopen.2023.7699.

ABSTRACT

IMPORTANCE: High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association between device modifications and risk to patient safety has not previously been analyzed.

OBJECTIVE: To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices from January 1, 2008, through December 31, 2021, giving a minimum 2-year follow-up after initial approval. Data were analyzed from July 6 to August 6, 2022. Retrospective, time-to-event analysis investigated the association between the number and type of supplements and risk of recall.

EXPOSURES: Supplements submitted by manufacturers for FDA approval to modify devices.

MAIN OUTCOMES AND MEASURES: A mixed-effects Cox proportional hazards regression model with frailty terms was used, modeling device recall as an outcome variable during the observation period. A second model was performed for class 1 (high-risk) recall. Explanatory variables are the number of supplements, number of panel track supplements, and cardiovascular devices. Multivariable analysis was performed to identify independent risk factors for recall with hazard ratios (HRs) as the main end point.

RESULTS: A total of 373 original PMA devices with 10 776 associated supplements were included in the analysis. A median 2.5 (IQR, 1.2-5.0) supplements per device were approved annually. Cardiovascular devices contributed 138 supplements (37.0%), followed by microbiology with 45 (12.1%). No other specialty contributed more than 10%. Multivariable analysis demonstrated that each increase of 1 supplement per year was associated with increased risk of recall (HR, 1.28 [95% CI, 1.15-1.44]; P < .001). For class 1 recall, increased number of supplements (HR, 1.32 [95% CI, 1.06-1.64]; P = .01) and cardiovascular vsnoncardiovascular classification of devices (HR, 3.51 [95% CI, 1.15-10.72]; P = .03) were significantly associated with an increased risk of recall.

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that PMA supplements are associated with an approximately 30% increased risk of any recall and class 1 recall. The FDA processes for approving modifications to high-risk medical devices should be reevaluated to optimize patient safety and public health.

PMID:37043202 | DOI:10.1001/jamanetworkopen.2023.7699

JAMA Netw Open. 2023 Apr 3;6(4):e237894. doi: 10.1001/jamanetworkopen.2023.7894.

ABSTRACT

IMPORTANCE: The aerosol box has been used during the management of patients with COVID-19 to reduce health care practitioner (HCP) exposure during aerosol-generating medical procedures (AGMPs). Little is known about the effect of aerosol box use on HCP contamination and AGMP procedure time.

OBJECTIVE: To investigate whether use of an aerosol box during AGMPs reduces HCP contamination or influences the time to successful completion and first-pass success rate for endotracheal intubation (ETI) and laryngeal mask airway (LMA) insertion.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, simulation-based, randomized clinical trial was conducted from May to December 2021 at tertiary care pediatric hospitals. Participant teams performed 3 simulated patient scenarios: bag-valve-mask ventilation, ETI, and LMA insertion. During the scenarios, aerosols were generated using Glo Germ. Teams of 2 HCPs were randomly assigned to control (no aerosol box) or intervention groups (aerosol box). Statistical analysis was performed from July 2022 to February 2023.

INTERVENTIONS: The aerosol box (or SplashGuard CG) is a transparent, plastic barrier covering the patient’s head and shoulders with access ports allowing HCPs to manage the airway.

MAIN OUTCOMES AND MEASURES: The primary outcome was surface area of contamination (AOC) on participants. Secondary outcomes were time to successful completion and first-pass success rates for ETI and LMA insertion.

RESULTS: A total of 64 teams (128 participants) were enrolled, with data from 61 teams (122 participants) analyzed. Among the 122 participants analyzed, 79 (64.8%) were female and 85 (69.7%) were physicians. Use of an aerosol box was associated with a 77.5% overall decreased AOC to the torso (95% CI, -86.3% to -62.9%; P < .001) and a 60.7% overall decreased AOC to the facial area (95% CI, -75.2% to -37.8%; P < .001) in airway HCPs. There was no statistically significant difference in surface contamination after doffing personal protective equipment between groups. Time to completing ETI was longer in the aerosol box group compared with the control group (mean difference: 10.2 seconds; 95% CI, 0.2 to 20.2 seconds; P = .04), but there was no difference between groups for LMA insertion (mean difference: 2.4 seconds; 95% CI, -8.7 to 13.5 seconds; P = .67).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of aerosol box use in AGMPs, use of an aerosol box reduced contamination deposition on HCPs’ torso and face predoffing; the use of an aerosol box delayed time to successful intubation. These results suggest that the incremental benefits of reduced surface contamination from aerosol box use should be weighed against delayed time to complete intubation, which may negatively affect patient outcome.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04880668.

PMID:37043197 | DOI:10.1001/jamanetworkopen.2023.7894