Category: Nevin Manimala

JMIR Mhealth Uhealth. 2023 Jan 23;11:e42799. doi: 10.2196/42799.

ABSTRACT

BACKGROUND: The World Health Organization recommends that all adults with HIV adhere to antiretroviral therapy (ART). Good adherence to ART is beneficial to patients and the public. Furthermore, mHealth has shown promise in improving HIV medication adherence globally.

OBJECTIVE: The aim of this meta-analysis is to analyze the effectiveness of mHealth on adherence to antiretroviral therapy in patients living with HIV.

METHODS: Randomized controlled trials (RCTs) of the association between mHealth and adherence to ART published until December 2021 were searched in electronic databases. Odds ratios (ORs), weighted mean differences, and 95% CIs were calculated. This meta-analysis was performed using the Mantel-Haenszel method or the inverse variance test. We evaluated heterogeneity with the I² statistic. If I² was ≤50%, heterogeneity was absent, and a fixed effect model was used. If I² was >50%, heterogeneity was present, and a random effects model was used.

RESULTS: A total of 2163 participants in 8 studies were included in this meta-analysis. All included studies were RCTs. The random effects model was used for a meta-analysis of the effects of various intervention measures compared to routine nursing; the outcome was not statistically significant (OR 1.54, 95% CI 0.99-2.38; P=.05). In the subgroups, only short messaging service (SMS)-based interventions significantly increased adherence to ART (OR 1.76, 95% CI 1.07-2.89; P=.03). Further analysis showed that only interactive or bidirectional SMS could significantly increase ART adherence (OR 1.69, 95% CI 1.22-2.34; P=.001). After combining the difference in CD4 cell count before and after the interventions, we concluded that there was no statistical heterogeneity among the studies (I²=0%; tau²=0.37; P=.95).

CONCLUSIONS: Interactive or bidirectional SMS can enhance intervention effects. However, whether mHealth can improve adherence to ART in patients with HIV needs further study. Owing to a lack of the required significant staff time, training, and ongoing supervision, there is still much more to do to apply mHealth to the clinical use of ART for patients living with HIV.

TRIAL REGISTRATION: PROSPERO CRD42022358774; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=358774.

PMID:36689267 | DOI:10.2196/42799

JMIR Ment Health. 2023 Jan 23;10:e37225. doi: 10.2196/37225.

ABSTRACT

BACKGROUND: Major depressive episode (MDE) is a common clinical syndrome. It can be found in different pathologies such as major depressive disorder (MDD), bipolar disorder (BD), posttraumatic stress disorder (PTSD), or even occur in the context of psychological trauma. However, only 1 syndrome is described in international classifications (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5]/International Classification of Diseases 11th Revision [ICD-11]), which do not take into account the underlying pathology at the origin of the MDE. Clinical interviews are currently the best source of information to obtain the etiological diagnosis of MDE. Nevertheless, it does not allow an early diagnosis and there are no objective measures of extracted clinical information. To remedy this, the use of digital tools and their correlation with clinical symptomatology could be useful.

OBJECTIVE: We aimed to review the current application of digital tools for MDE diagnosis while highlighting shortcomings for further research. In addition, our work was focused on digital devices easy to use during clinical interview and mental health issues where depression is common.

METHODS: We conducted a narrative review of the use of digital tools during clinical interviews for MDE by searching papers published in PubMed/MEDLINE, Web of Science, and Google Scholar databases since February 2010. The search was conducted from June to September 2021. Potentially relevant papers were then compared against a checklist for relevance and reviewed independently for inclusion, with focus on 4 allocated topics of (1) automated voice analysis, behavior analysis by (2) video and physiological measures, (3) heart rate variability (HRV), and (4) electrodermal activity (EDA). For this purpose, we were interested in 4 frequently found clinical conditions in which MDE can occur: (1) MDD, (2) BD, (3) PTSD, and (4) psychological trauma.

RESULTS: A total of 74 relevant papers on the subject were qualitatively analyzed and the information was synthesized. Thus, a digital phenotype of MDE seems to emerge consisting of modifications in speech features (namely, temporal, prosodic, spectral, source, and formants) and in speech content, modifications in nonverbal behavior (head, hand, body and eyes movement, facial expressivity, and gaze), and a decrease in physiological measurements (HRV and EDA). We not only found similarities but also differences when MDE occurs in MDD, BD, PTSD, or psychological trauma. However, comparative studies were rare in BD or PTSD conditions, which does not allow us to identify clear and distinct digital phenotypes.

CONCLUSIONS: Our search identified markers from several modalities that hold promise for helping with a more objective diagnosis of MDE. To validate their potential, further longitudinal and prospective studies are needed.

PMID:36689265 | DOI:10.2196/37225

J Chin Med Assoc. 2023 Jan 23. doi: 10.1097/JCMA.0000000000000883. Online ahead of print.

ABSTRACT

BACKGROUND: Neoadjuvant systemic therapy (NST) is conducted in increased patients with breast cancer overexpressing human epidermal growth factor receptor 2 (HER2). Whether the intensity of HER2 protein expression determines response to treatment is challenged. This study aims to analyse the impact of HER2 immunohistochemical (IHC) scores on NST response and survival outcome.

METHODS: We analysed a total of 197 patients with HER2-positive breast cancer receiving NST and definite surgery from a prospectively collected database. The analysed end points included pathological complete response (pCR), disease-free survival (DFS) and overall survival (OS). More patients with IHC 2+/in situ hybridization (ISH)-positive tumours presented positive for hormonal receptors, compared to those with IHC 3+ tumours. No clinicopathological features except tumour necrosis were significantly associated with pCR.

RESULTS: Both positive hormone receptors and IHC scores stood on the borderline in statistical analysis. IHC 3+ group tends to present a higher pCR rate than IHC 2+/ISH+ groups (52.5% vs. 34.3%). Patients who achieved pCR had better survival outcome than that of non-pCR group. The impact of pCR on survival reached the statistical significance in the IHC 3+ group both in DFS (90.9% vs. 76.5%, p=0.004) and OS (97.4% vs. 83.2%, p=0.002). Multivariate analysis demonstrated IHC scores as an independent predictor of survival outcome with the adjustment of tumour staging and pCR.

CONCLUSION: HER2 IHC score is an independent predictor for outcome. IHC 3+ tumours presented a trend of higher pCR rate and better outcome in HER2-positive breast cancer patients who receive NST.

PMID:36689250 | DOI:10.1097/JCMA.0000000000000883

JAMA. 2023 Jan 23. doi: 10.1001/jama.2022.25080. Online ahead of print.

NO ABSTRACT

PMID:36689237 | DOI:10.1001/jama.2022.25080

JAMA Netw Open. 2023 Jan 3;6(1):e2251182. doi: 10.1001/jamanetworkopen.2022.51182.

ABSTRACT

IMPORTANCE: While research has identified racial and ethnic disparities in access to autism services, the size, extent, and specific locations of these access gaps have not yet been characterized on a national scale. Mapping comprehensive national listings of autism health care services together with the prevalence of autistic children of various races and ethnicities and evaluating geographic regions defined by localized commuting patterns may help to identify areas within the US where families who belong to minoritized racial and ethnic groups have disproportionally lower access to services.

OBJECTIVE: To evaluate differences in access to autism health care services among autistic children of various races and ethnicities within precisely defined geographic regions encompassing all serviceable areas within the US.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cross-sectional study was conducted from October 5, 2021, to June 3, 2022, and involved 530 965 autistic children in kindergarten through grade 12. Core-based statistical areas (CBSAs; defined as areas containing a city and its surrounding commuter region), the Civil Rights Data Collection (CRDC) data set, and 51 071 autism resources (collected from October 1, 2015, to December 18, 2022) geographically distributed into 912 CBSAs were combined and analyzed to understand variation in access to autism health care services among autistic children of different races and ethnicities. Six racial and ethnic categories (American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or other Pacific Islander, and White) assigned by the US Department of Education were included in the analysis.

MAIN OUTCOMES AND MEASURES: A regularized least-squares regression analysis was used to measure differences in nationwide resource allocation between racial and ethnic groups. The number of autism resources allocated per autistic child was estimated based on the child’s racial and ethnic group. To evaluate how the CBSA population size may have altered the results, the least-squares regression analysis was run on CBSAs divided into metropolitan (>50 000 inhabitants) and micropolitan (10 000-50 000 inhabitants) groups. A Mann-Whitney U test was used to compare the model estimated ratio of autism resources to autistic children among specific racial and ethnic groups comprising the proportions of autistic children in each CBSA.

RESULTS: Among 530 965 autistic children aged 5 to 18 years, 83.9% were male and 16.1% were female; 0.7% of children were American Indian or Alaska Native, 5.9% were Asian, 14.3% were Black or African American, 22.9% were Hispanic or Latino, 0.2% were Native Hawaiian or other Pacific Islander, 51.7% were White, and 4.2% were of 2 or more races and/or ethnicities. At a national scale, American Indian or Alaska Native autistic children (β = 0; 95% CI, 0-0; P = .01) and Hispanic autistic children (β = 0.02; 95% CI, 0-0.06; P = .02) had significant disparities in access to autism resources in comparison with White autistic children. When evaluating the proportion of autistic children in each racial and ethnic group, areas in which Black autistic children (>50% of the population: β = 0.05; <50% of the population: β = 0.07; P = .002) or Hispanic autistic children (>50% of the population: β = 0.04; <50% of the population: β = 0.07; P < .001) comprised greater than 50% of the total population of autistic children had significantly fewer resources than areas in which Black or Hispanic autistic children comprised less than 50% of the total population. Comparing metropolitan vs micropolitan CBSAs revealed that in micropolitan CBSAs, Black autistic children (β = 0; 95% CI, 0-0; P < .001) and Hispanic autistic children (β = 0; 95% CI, 0-0.02; P < .001) had the greatest disparities in access to autism resources compared with White autistic children. In metropolitan CBSAs, American Indian or Alaska Native autistic children (β = 0; 95% CI, 0-0; P = .005) and Hispanic autistic children (β = 0.01; 95% CI, 0-0.06; P = .02) had the greatest disparities compared with White autistic children.

CONCLUSIONS AND RELEVANCE: In this study, autistic children from several minoritized racial and ethnic groups, including Black and Hispanic autistic children, had access to significantly fewer autism resources than White autistic children in the US. This study pinpointed the specific geographic regions with the greatest disparities, where increases in the number and types of treatment options are warranted. These findings suggest that a prioritized response strategy to address these racial and ethnic disparities is needed.

PMID:36689227 | DOI:10.1001/jamanetworkopen.2022.51182

JAMA Netw Open. 2023 Jan 3;6(1):e2251974. doi: 10.1001/jamanetworkopen.2022.51974.

ABSTRACT

IMPORTANCE: The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts.

OBSERVATIONS: To support the rapid development of vaccines for the US population and the rest of the world, the National Institute of Allergy and Infectious Diseases established the COVID-19 Prevention Network (CoVPN) to assist in the coordination and implementation of phase 3 efficacy trials for COVID-19 vaccine candidates and monoclonal antibodies. By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 vaccine trials as soon as the investigational products were ready for phase 3 testing. The mission of CoVPN was to operationalize phase 3 vaccine trials using harmonized protocols, laboratory assays, and a single data and safety monitoring board to oversee the various studies. These trials, while staggered in time of initiation, overlapped in time and course of conduct and ultimately led to the successful completion of multiple studies and US Food and Drug Administration-licensed or -authorized vaccines, the first of which was available to the public less than 1 year from the discovery of the virus.

CONCLUSIONS AND RELEVANCE: This Special Communication describes the design, geographic distribution, and underlying principles of conduct of these efficacy trials and summarizes data from 136 382 prospectively followed-up participants, including more than 2500 with documented COVID-19. These successful efforts can be replicated for other important research initiatives and point to the importance of investments in clinical trial infrastructure integral to pandemic preparedness.

PMID:36689221 | DOI:10.1001/jamanetworkopen.2022.51974

Phys Eng Sci Med. 2023 Jan 23. doi: 10.1007/s13246-023-01219-6. Online ahead of print.

ABSTRACT

Recent technological advances have allowed the possibility of performing patient-specific quality assurance (QA) without time-intensive measurements. The objectives of this study are to: (1) compare how well the log file-based Mobius QA system agrees with measurement-based QA methods (ArcCHECK and portal dosimetry, PD) in passing and failing plans, and; (2) evaluate their error sensitivities. To these ends, ten phantom plans and 100 patient plans were measured with ArcCHECK and PD on VitalBeam, while log files were sent to Mobius for dose recalculation. Gamma evaluation was performed using criteria 3%/2 mm, per TG218 recommendations, and non-inferiority of the Mobius recalculation was determined with statistical testing. Ten random plans were edited to include systematic errors, then subjected to QA. Receiver operating characteristic curves were constructed to compare error sensitivities across the QA systems, and clinical significance of the errors was determined by recalculating dose to patients. We found no significant difference between Mobius, ArcCHECK, and PD in passing plans at the TG218 action limit. Mobius showed good sensitivity to collimator and gantry errors but not MLC bank shift errors, but could flag discrepancies in treatment delivery. Systematic errors were clinically significant only at large magnitudes; such unacceptable plans did not pass QA checks at the TG218 tolerance limit. Our results show that Mobius is not inferior to existing measurement-based QA systems, and can supplement existing QA practice by detecting real-time delivery discrepancies. However, it is still important to maintain rigorous routine machine QA to ensure reliability of machine log files.

PMID:36689188 | DOI:10.1007/s13246-023-01219-6

J Gastrointest Surg. 2023 Jan 23. doi: 10.1007/s11605-022-05575-8. Online ahead of print.

ABSTRACT

BACKGROUND: The complexity of the upper gastrointestinal (UGI) multidisciplinary team (MDT) is continually growing, leading to rising clinician workload, time pressures, and demands. This increases heterogeneity or ‘noise’ within decision-making for patients with oesophageal cancer (OC) and may lead to inconsistent treatment decisions. In recent decades, the application of artificial intelligence (AI) and more specifically the branch of machine learning (ML) has led to a paradigm shift in the perceived utility of statistical modelling within healthcare. Within oesophageal cancer (OC) care, ML techniques have already been applied with early success to the analyses of histological samples and radiology imaging; however, it has not yet been applied to the MDT itself where such models are likely to benefit from incorporating information-rich, diverse datasets to increase predictive model accuracy.

METHODS: This review discusses the current role the MDT plays in modern UGI cancer care as well as the utilisation of ML techniques to date using histological and radiological data to predict treatment response, prognostication, nodal disease evaluation, and even resectability within OC.

RESULTS: The review finds that an emerging body of evidence is growing in support of ML tools within multiple domains relevant to decision-making within OC including automated histological analysis and radiomics. However, to date, no specific application has been directed to the MDT itself which routinely assimilates this information.

CONCLUSIONS: The authors feel the UGI MDT offers an information-rich, diverse array of data from which ML offers the potential to standardise, automate, and produce more consistent, data-driven MDT decisions.

PMID:36689150 | DOI:10.1007/s11605-022-05575-8

Drug Saf. 2023 Jan 23. doi: 10.1007/s40264-022-01269-x. Online ahead of print.

ABSTRACT

INTRODUCTION: Deliberate self-poisoning (DSP) using drugs is the preferred method of suicide at a global level. Its investigation is hampered by limited sample sizes and data reliability. We investigate the role of the US FDA Adverse Event Reporting System (FAERS), a consolidated pharmacovigilance database, in outlining DSP habits and toxidromes.

METHODS: We retrieved cases of ‘intentional overdose’ and ‘poisoning deliberate’ from the FAERS (January 2004-December 2021). Using descriptive and disproportionality analyses, we estimated temporal trends, potential risk factors, toxidromes, case-fatality rates and lethal doses (LDs) for the most frequently reported drugs.

RESULTS: We retrieved 42,103 DSP cases (17% fatal). Most cases were submitted in winter. Reports of DSP involved younger people, psychiatric conditions, and alcohol use, compared with non-DSP, and fatality was higher in men and older patients. Suspected drugs were mainly antidepressants, analgesics, and antipsychotics. Multiple drug intake was recorded in more than 50% of the reports, especially analgesics, psychotropics, and cardiovascular agents. The most frequently reported drugs were paracetamol, promethazine, amlodipine, quetiapine, and metformin. We estimated LD25 for paracetamol (150 g).

CONCLUSION: Worldwide coverage of the FAERS complements existing knowledge about DSP and may drive tailored prevention measures to timely address the DSP phenomenon and prevent intentional suicides.

PMID:36689131 | DOI:10.1007/s40264-022-01269-x

Can J Public Health. 2023 Jan 23. doi: 10.17269/s41997-022-00736-3. Online ahead of print.

ABSTRACT

OBJECTIVES: Canada’s ongoing drug poisoning crisis has contributed to unprecedented rates of morbidity and mortality. Health Canada has funded safer supply pilot programs to help connect people who use drugs to pharmaceutical grade medications that reduce their reliance on a toxic drug supply. However, most provinces, including Alberta and Saskatchewan, have not endorsed these initiatives. We explored public support for safer supply programs in these two Canadian provinces and identified predictors of support for this policy option.

METHODS: Cross-sectional data were examined from an online panel survey that included measures assessing views on policy responses to substance use and addiction. A total of 1602 adults were recruited during March 2021. We used descriptive statistics to characterize support for safer supply programs in Alberta and Saskatchewan and multinominal logistic regression analysis to examine predictors of public support for safer supply.

RESULTS: The majority of respondents (AB: 63.5% and SK: 56.3%) supported safer supply programs that replace illegal street drugs with pharmaceutical alternatives for those unable to stop using. Predicted probabilities show a greater probability of support for safer supply among those with higher education and those leaning left on the political spectrum.

CONCLUSION: A majority of Canadians from Alberta and Saskatchewan supported provincial government efforts to expand safer supply, suggesting a lack of public support is not the main barrier to implementation. Efforts at mobilizing this public opinion are needed to scale up and facilitate evaluation of this drug poisoning response.

PMID:36689127 | DOI:10.17269/s41997-022-00736-3