Categories
Nevin Manimala Statistics

Early OxyContin Marketing Linked To Long-Term Spread Of Infectious Diseases Associated With Injection Drug Use

Health Aff (Millwood). 2023 Jul 19:101377hlthaff202300146. doi: 10.1377/hlthaff.2023.00146. Online ahead of print.

ABSTRACT

The initial marketing of the opioid analgesic OxyContin in 1996 increased fatal drug overdoses over the course of the opioid epidemic in the US. However, the long-term impacts of this marketing on complications of injection drug use, a key feature of the ongoing crisis, are undetermined. This study evaluated the effects of exposure to initial OxyContin marketing on the long-term trajectories of injection drug use-related outcomes in the US. We used a difference-in-differences analysis to compare outcomes in states with high versus low exposure to initial marketing before and after the 2010 reformulation of OxyContin, which facilitated the use of illicit drugs and the spread of infectious disease. Exposure to initial OxyContin marketing statistically significantly increased rates of fatal synthetic opioid-related overdoses; acute hepatitis A, B, and C viral infections; and infective endocarditis-related deaths. The greatest burden of adverse long-term outcomes has been in states that experienced the highest exposure to early OxyContin marketing. Our findings indicate that OxyContin marketing decisions from the mid-1990s increased viral and bacterial complications of injection drug use and illicit opioid-related overdose deaths twenty-five years later.

PMID:37467441 | DOI:10.1377/hlthaff.2023.00146

Categories
Nevin Manimala Statistics

Cardiovascular autonomic neuropathy and risk of kidney function decline in type 1 and type 2 diabetes: findings from the PERL and ACCORD cohorts

Diabetes. 2023 Jul 19:db230247. doi: 10.2337/db23-0247. Online ahead of print.

ABSTRACT

Previous studies have suggested that cardiovascular autonomic neuropathy (CAN) may predict rapid kidney function decline among persons with diabetes. We analyzed the association between baseline CAN and subsequent glomerular filtration rate (GFR) decline among individuals with type 1 diabetes (T1D) from the Preventing Early Renal Loss in Diabetes (PERL) study (N=469) and with type 2 diabetes (T2D) from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study (N=7,973). Baseline CAN was ascertained using ECG-derived heart rate variability indices. Its association with GFR slopes, rapid kidney function decline (GFR loss ≥-5 ml/min/1.73 m2/year), and ≥40% GFR loss was evaluated by linear mixed effect, logistic, and Cox regression, respectively. Participants with CAN experienced more rapid GFR decline, by an excess 1.15 (95%CI [-1.93, -0.37], P= 4.0×10-3) ml/min/1.73m2/year in PERL and 0.34 (95%CI [-0.49, -0.19], P= 6.3×10-6) ml/min/1.73m2/year in ACCORD. This translated in 2.11 (95% CI [1.23-3.63], P=6.9×10-3) and 1.39 (95% CI [1.20-1.61], P=1.1×10-5) odds ratios of rapid kidney function decline in PERL and ACCORD, respectively. Baseline CAN was also associated with a greater risk of ≥40% GFR loss events during follow-up (HR=2.60, 95%CI [1.15-5.45], p=0.02 in PERL and HR=1.54, 95%CI [1.28-1.84], P=3.8×10-6 in ACCORD). These associations remained significant after adjustment for potential confounders, including baseline GFR and albuminuria. Our findings indicate that CAN is a strong, independent predictor of rapid kidney function decline in both T1D and T2D. Further studies of the link between these two complications may help develop new therapies to prevent kidney function decline in patients with diabetes.

PMID:37467433 | DOI:10.2337/db23-0247

Categories
Nevin Manimala Statistics

Individual Participant Data Network Meta-Analysis of Neoadjuvant Chemotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Junction Carcinoma

J Clin Oncol. 2023 Jul 12:JCO2202279. doi: 10.1200/JCO.22.02279. Online ahead of print.

ABSTRACT

PURPOSE: The optimal neoadjuvant treatment for resectable carcinoma of the thoracic esophagus (TE) or gastroesophageal junction (GEJ) remains a matter of debate. We performed an individual participant data (IPD) network meta-analysis (NMA) of randomized controlled trials (RCTs) to study the effect of chemotherapy or chemoradiotherapy, with a focus on tumor location and histology subgroups.

PATIENTS AND METHODS: All, published or unpublished, RCTs closed to accrual before December 31, 2015 and having compared at least two of the following strategies were eligible: upfront surgery (S), chemotherapy followed by surgery (CS), and chemoradiotherapy followed by surgery (CRS). All analyses were conducted on IPD obtained from investigators. The primary end point was overall survival (OS). The IPD-NMA was analyzed by a one-step mixed-effect Cox model adjusted for age, sex, tumor location, and histology. The NMA was registered in PROSPERO (CRD42018107158).

RESULTS: IPD were obtained for 26 of 35 RCTs (4,985 of 5,807 patients) corresponding to 12 comparisons for CS-S, 12 for CRS-S, and four for CRS-CS. CS and CRS led to increased OS when compared with S with hazard ratio (HR) = 0.86 (0.75 to 0.99), P = .03 and HR = 0.77 (0.68 to 0.87), P < .001 respectively. The NMA comparison of CRS versus CS for OS gave a HR of 0.90 (0.74 to 1.09), P = .27 (consistency P = .26, heterogeneity P = .0038). For CS versus S, a larger effect on OS was observed for GEJ versus TE tumors (P = .036). For the CRS versus S and CRS versus CS, a larger effect on OS was observed for women (P = .003, .012, respectively).

CONCLUSION: Neoadjuvant chemotherapy and chemoradiotherapy were consistently better than S alone across histology, but with some variation in the magnitude of treatment effect by sex for CRS and tumor location for CS. A strong OS difference between CS and CRS was not identified.

PMID:37467395 | DOI:10.1200/JCO.22.02279

Categories
Nevin Manimala Statistics

A Cross-Sectional Evaluation of Publication Bias in the Plastic Surgery Literature

Plast Reconstr Surg. 2023 Jul 18. doi: 10.1097/PRS.0000000000010931. Online ahead of print.

ABSTRACT

BACKGROUND: Publication bias (PB) is the preferential publishing of studies with statistically significant results. PB can skew findings of systematic reviews (SR) and meta-analyses (MA), with potential consequences for patient care and health policy. This study aims to determine the extent by which SRs and MAs in the plastic surgery literature evaluate and report PB.

METHODS: This cross-sectional study assessed PB reporting and analysis from plastic surgery studies published between January 1, 2015 and June 19, 2020. Full-texts of SRs and MAs were assessed by two reviewers for PB assessment methodology and analysis. Post-hoc assessment of studies that did not originally analyze PB was performed using Egger’s regression, Duval and Tweedie’s trim-and-fill, and Copas selection models.

RESULTS: There were 549 studies evaluated, of which 531 full-texts were included. PB was discussed by 183 (34.5%) studies, and formally assessed by 97 (18.3%) studies. Among SR and MAs that formally assessed PB, PB was present in 24 (10.7%), not present in 52 (23.1%), and inconclusive in 8 (3.6%) studies; 141 (62.7%) studies did not report the results of their PB assessment. Funnel plots were the most common assessment method (n=88, 39.1%), and 60 (68.2%) studies published funnel plots. The post-hoc assessment revealed PB in 17/20 (85.0%) studies.

CONCLUSION: PB is inadequately reported and analyzed amongst studies in the plastic surgery literature. Most studies that assessed PB found PB, as did post-hoc analysis of non-reporting studies. Increased assessment and reporting of PB amongst SRs and MAs would improve quality of evidence in plastic surgery.

PMID:37467390 | DOI:10.1097/PRS.0000000000010931

Categories
Nevin Manimala Statistics

Statistical Detection of Differentially Abundant Proteins in Experiments with Repeated Measures Designs and Isobaric Labeling

J Proteome Res. 2023 Jul 19. doi: 10.1021/acs.jproteome.3c00155. Online ahead of print.

ABSTRACT

Repeated measures experimental designs, which quantify proteins in biological subjects repeatedly over multiple experimental conditions or times, are commonly used in mass spectrometry-based proteomics. Such designs distinguish the biological variation within and between the subjects and increase the statistical power of detecting within-subject changes in protein abundance. Meanwhile, proteomics experiments increasingly incorporate tandem mass tag (TMT) labeling, a multiplexing strategy that gains both relative protein quantification accuracy and sample throughput. However, combining repeated measures and TMT multiplexing in a large-scale investigation presents statistical challenges due to unique interplays of between-mixture, within-mixture, between-subject, and within-subject variation. This manuscript proposes a family of linear mixed-effects models for differential analysis of proteomics experiments with repeated measures and TMT multiplexing. These models decompose the variation in the data into the contributions from its sources as appropriate for the specifics of each experiment, enable statistical inference of differential protein abundance, and recognize a difference in the uncertainty of between-subject versus within-subject comparisons. The proposed family of models is implemented in the R/Bioconductor package MSstatsTMT v2.2.0. Evaluations of four simulated datasets and four investigations answering diverse biological questions demonstrated the value of this approach as compared to the existing general-purpose approaches and implementations.

PMID:37467362 | DOI:10.1021/acs.jproteome.3c00155

Categories
Nevin Manimala Statistics

Evaluation of Uncertainties in the Anthropogenic SO2 Emissions in the USA from the OMI Point Source Catalog

Environ Sci Technol. 2023 Jul 19. doi: 10.1021/acs.est.2c07056. Online ahead of print.

ABSTRACT

Satellite remote sensing is a promising method of monitoring emissions that may be missing in inventories, but the accuracy of these estimates is often not clear. We demonstrate here a comprehensive evaluation of errors in anthropogenic sulfur dioxide (SO2) emission estimates from NASA’s OMI point source catalog for the contiguous US by comparing emissions from the catalog with high-quality emission inventory data over different dimensions including size of individual sources, aggregate vs individual source errors, and potential bias in individual source estimates over time. For sources that are included in the catalog, we find that errors in aggregate (sum of error for all included sources) are relatively low. Errors for individual sources in any given year can be substantial, however, with over- or underestimates in terms of total error ranging from -80 to 110 kt (roughly 10-90th percentile). We find that these errors are not necessarily random over time and that there can be consistently positive or negative biases for individual sources. We did not find any overall statistical relationship between the degree of isolation of a source and bias, either at a 40 or 70 km scales. For a sub-set of sources where inventory emissions over a radius of 70 km around an OMI detection are larger than twice the emissions within 40 km, the OMI value is consistently overestimated. We find, as expected, that emission sources not included in the catalog are the largest aggregate source of difference between the satellite estimates and inventories, especially in more recent years where source emission magnitudes have been decreasing and note that trends in satellite detections do not necessarily track trends in total emissions. We find that the OMI-based SO2 emissions are accurate in aggregate, when summed over a number of sources, but must be interpreted more cautiously at the individual source level. Similar analyses would be valuable for other satellite emission estimates; however, in many cases, the appropriate high-quality reference data may need to be generated.

PMID:37467360 | DOI:10.1021/acs.est.2c07056

Categories
Nevin Manimala Statistics

Serologic testing for Rocky Mountain spotted fever in a low-incidence region

J Pediatric Infect Dis Soc. 2023 Jul 19:piad051. doi: 10.1093/jpids/piad051. Online ahead of print.

ABSTRACT

BACKGROUND: Tick-borne diseases have grown in incidence over recent decades. As a result, diagnostic testing has become more common, often performed as broad antibody-based panels for multiple tick-transmitted pathogens. Rocky Mountain spotted fever (RMSF) is rare in our region yet may cause severe morbidity, leading to diagnostic screening in low-risk patients. We sought to describe trends in RMSF diagnostic testing, rate of IgG seropositivity, and clinical features of those tested.

METHODS: We performed a retrospective chart review of patients ≤ 21 years old undergoing testing for RMSF and/or with an ICD-9/10 code for RMSF. Patients were categorized by infection likelihood based on clinical and laboratory criteria adapted from CDC’s case definition of spotted fever rickettsioses. Clinical data were collected and analyzed with descriptive statistics.

RESULTS: 170 patients were included. 5.8% met CDC criteria for rickettsial infection, 6.5% had an elevated IgG titer but lacked suggestive symptoms, and 87.6% had a negative IgG titer. Many patients tested were unlikely to have RMSF, including 50% lacking fever, 20% lacking any RMSF ‘classic triad’ symptoms, 13% without acute illness, and 22% tested during months with low tick activity. Convalescent serology was performed in 7.6% of patients and none underwent R. rickettsii PCR testing.

CONCLUSIONS: Diagnostic testing was frequently performed in patients unlikely to have RMSF. We identified many opportunities for improving test utilization. Reserving testing for those with higher pre-test probability, performing convalescent serology, and utilizing PCR may improve accuracy of RMSF diagnosis and reduce clinical challenges stemming from inappropriate testing.

PMID:37467350 | DOI:10.1093/jpids/piad051

Categories
Nevin Manimala Statistics

Evaluation of failure rate of molar tubes with a modified bonding technique: a randomized clinical trial

Eur J Orthod. 2023 Jul 19:cjad029. doi: 10.1093/ejo/cjad029. Online ahead of print.

ABSTRACT

BACKGROUND: During orthodontic therapy, bond failure of molar tubes may delay treatment. With the high failure rate of molar tubes, alternative bonding techniques were tested to improve bond strength.

OBJECTIVES: To compare the failure rates of molar tubes bonded with conventional and alternative bonding techniques by adding a layer of compomer adhesive at the molar/tube interface.

TRIAL DESIGN: Single-centre, single-blinded, split-mouth, randomized clinical trial.

METHODS: Patients aged 12 years or older, who required fixed appliance orthodontic treatment without extraction and with no occlusal interference were eligible to participate. They were allocated randomly using a simple non-stratified split-mouth design with a 1:1 allocation ratio. Blinding was only possible for the patients and data analysts. Molar tubes bonded with the modified bonding technique had an additional layer of compomer at the occlusal molar/tube interface. The patients were followed-up for nine months. Outcome measures included the survival time of molar tubes and the number of molar tubes debonded. The bond failure of molar tubes was analyzed using Kaplan-Meier and Cox regression analysis (P < 0.05).

RESULTS: Thirty patients were recruited, randomized, and analyzed (mean age 20.33 years). The failure rate of molar tubes bonded with the modified bonding technique was 4.2 per cent and that of molar tubes bonded with the conventional bonding technique was 6.7 per cent. This difference was not statistically significant (P > 0.05). The dental arch and molar type were found to be as significant predictors for molar tube failure rate. No harm was detected during treatment.

LIMITATIONS: The effect of compomer to reduce enamel demineralization was not tested.

CONCLUSIONS AND IMPLICATIONS: The modified bonding technique did not significantly reduce the failure rate of molar tubes. The molar tubes bonded on the upper arch and second molars are more susceptible to debond.

REGISTRATION: The trial was registered with ClinicalTrials.gov on 21 May 2022 (Registration number: NCT05391386).

FUNDING: This research did not receive any funding.

PMID:37467348 | DOI:10.1093/ejo/cjad029

Categories
Nevin Manimala Statistics

Poor treatment outcome and associated risk factors among patients with isoniazid mono-resistant tuberculosis: A systematic review and meta-analysis

PLoS One. 2023 Jul 19;18(7):e0286194. doi: 10.1371/journal.pone.0286194. eCollection 2023.

ABSTRACT

BACKGROUND: To date, isoniazid mono-resistant tuberculosis (TB) is becoming an emerging global public health problem. It is associated with poor treatment outcome. Different studies have assessed the treatment outcome of isoniazid mono-resistant TB cases, however, the findings are inconsistent and there is limited global comprehensive report. Thus, this study aimed to assess the poor treatment outcome and its associated risk factors among patients with isoniazid mono-resistant TB.

METHODS: Studies that reported the treatment outcomes and associated factors among isoniazid mono-resistant TB were searched from electronic databases and other sources. We used Joana Briggs Institute critical appraisal tool to assess the study’s quality. We assessed publication bias through visual inspection of the funnel plot and confirmed by Egger’s regression test. We used STATA version 17 for statistical analysis.

RESULTS: Among 347 studies identified from the whole search, data were extracted from 25 studies reported from 47 countries. The pooled successful and poor treatment outcomes were 78% (95%CI; 74%-83%) and 22% (95%CI; 17%-26%), respectively. Specifically, complete, cure, treatment failure, mortality, loss to follow-up and relapse rates were 34%(95%CI; 17%-52%), 62% (95%CI; 50%-73%), 5% (95%CI; 3%-7%), 6% (95%CI; 4%-8%), 12% (95%CI; 8%-17%), and 1.7% (95%CI; 0.4%-3.1%), respectively. Higher prevalence of pooled poor treatment outcome was found in the South East Asian Region (estimate; 40%, 95%C; 34%-45%), and African Region (estimate; 33%, 95%CI; 24%-42%). Previous TB treatment (OR; 1.74, 95%CI; 1.15-2.33), having cancer (OR; 3.53, 95%CI; 1.43-5.62), and being initially smear positive (OR; 1.26, 95%CI; 1.08-1.43) were associated with poor treatment outcome. While those patients who took rifampicin in the continuation phase (OR; 0.22, 95%CI; 0.04-0.41), had extrapulmonary TB (OR; 0.70, 95%CI; 0.55-0.85), and took second-line injectable drugs (OR; 0.54, 95%CI; 0.33-0.75) had reduced risk of poor treatment outcome.

CONCLUSION: Isoniazid mono-resistant TB patients had high poor treatment outcome. Thus, determination of isoniazid resistance pattern for all bacteriologically confirmed TB cases is critical for successful treatment outcome. PROSPERO registration number: CRD42022372367.

PMID:37467275 | DOI:10.1371/journal.pone.0286194

Categories
Nevin Manimala Statistics

Attitudes Toward Seeking Mental Health Services and Mobile Technology to Support the Management of Depression Among Black American Women: Cross-Sectional Survey Study

J Med Internet Res. 2023 Jul 19;25:e45766. doi: 10.2196/45766.

ABSTRACT

BACKGROUND: Depression is a common mental health condition among Black American women. Many factors may contribute to the development of depressive symptoms, such as gender and racial discrimination, financial strain, chronic health conditions, and caregiving responsibilities. Barriers such as the stigmatization of mental illness, less access to treatment, the lack of or inadequate health insurance, mistrust of providers, and limited health literacy prevent marginalized populations from seeking care. Previous literature has shown that mobile health interventions are effective and can increase access to mental health services and resources.

OBJECTIVE: We aimed to understand the attitudes and perceptions of Black women toward using mental health services and determine the acceptability and concerns of using mobile technology (ie, voice call, video call, SMS text messaging, and mobile app) to support the management of depression.

METHODS: We launched a self-administered web-based questionnaire in October 2019 and closed it in January 2020. Women (aged ≥18 years) who identify as Black or African American or multiracial (defined as Black or African American and another race) were eligible to participate. The survey consisted of approximately 70 questions and included topics such as attitudes toward seeking professional psychological help, the acceptability of using a mobile phone to receive mental health care, and screening for depression.

RESULTS: The findings (n=395) showed that younger Black women were more likely to have greater severity of depression than their older counterparts. The results also revealed that Black women have favorable views toward seeking mental health services. Respondents were the most comfortable with the use of voice calls or video calls to communicate with a professional to receive support for managing depression in comparison with SMS text messaging or mobile apps. The results revealed that higher help-seeking propensity increased the odds of indicating agreement with the use of voice calls and video calls to communicate with a professional to receive support for managing depression by 27% and 38%, respectively. However, no statistically significant odds ratios (all P>.05) were found between help-seeking propensity and respondents’ agreement to use mobile apps or SMS text messaging. Moderate to severe depression severity increased the odds of using mobile apps to communicate with a professional to receive support for managing depression by 43%; however, no statistically significant odds ratios existed for the other modalities. Privacy and confidentiality, communication issues (eg, misinterpreting text), and the impersonal feeling of communicating by mobile phone (eg, SMS text messaging) were the primary concerns.

CONCLUSIONS: Black American women, in general, have favorable views toward seeking mental health services and are comfortable with the use of mobile technology to receive support for managing depression. Future work should address the issues of access and consider the preferences and cultural appropriateness of the resources provided.

PMID:37467027 | DOI:10.2196/45766