Nevin Manimala

JMIR Res Protoc. 2023 Aug 9;12:e47018. doi: 10.2196/47018.

ABSTRACT

BACKGROUND: Globally, over 20 million children are unvaccinated and over 25 million missed their follow-up doses during the COVID-19 pandemic; thus, they face vaccine-preventable diseases and unnecessary deaths. This is especially the case for those with HIV or living in vulnerable settings. Using cell phones to send reminders to parents has been shown to improve vaccination rates.

OBJECTIVE: We aim to determine whether implementation of an automated SMS reminder will improve child vaccination rates in a turbulent, semiurban/semirural setting in a low-income country.

METHODS: This will be a nonrandomized controlled trial that will be conducted at Azire Integrated Health Centre, Bamenda, Cameroon.

RESULTS: A total of 200 parents per study group (aged over 18 years) who are registered at the clinic at least one month prior to the study will be recruited. The intervention group will receive 2 reminders: 1 week and 2 days prior to the scheduled vaccination. For those who miss their appointments, a reminder will be sent 1 week after their missed appointment. The control group will receive the regular care provided at the clinic. Baseline information, clinical visit data, and vaccination records will be collected for both groups. Descriptive statistics will be used to summarize baseline characteristics between and within clusters and groups. The Fisher exact test will be used to compare parent-child units who return for follow-up visits (as a percentage) and children vaccinated as scheduled (as a percentage) between the study groups. Finally, we will compare how many members of both study groups return for 1 follow-up visit using Kaplan-Meier survival analysis.

CONCLUSIONS: Due to limited effective child vaccination interventions in unstable settings, this study will be of high importance for suggesting a holistic approach to improve child vaccination and public health.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47018.

PMID:37556178 | DOI:10.2196/47018

JAMA Surg. 2023 Aug 9. doi: 10.1001/jamasurg.2023.3352. Online ahead of print.

ABSTRACT

IMPORTANCE: There has been increasing legislative interest in regulating gender-affirming surgery, in part due to the concern about decisional regret. The regret rate following gender-affirming surgery is thought to be approximately 1%; however, previous studies relied heavily on ad hoc instruments.

OBJECTIVE: To evaluate long-term decisional regret and satisfaction with decision using validated instruments following gender-affirming mastectomy.

DESIGN, SETTING, AND PARTICIPANTS: For this cross-sectional study, a survey of patient-reported outcomes was sent between February 1 and July 31, 2022, to patients who had undergone gender-affirming mastectomy at a US tertiary referral center between January 1, 1990, and February 29, 2020.

EXPOSURE: Decisional regret and satisfaction with decision to undergo gender-affirming mastectomy.

MAIN OUTCOMES AND MEASURES: Long-term patient-reported outcomes, including the Holmes-Rovner Satisfaction With Decision scale, the Decision Regret Scale, and demographic characteristics, were collected. Additional information was collected via medical record review. Descriptive statistics and univariable analysis using Fisher exact and Wilcoxon rank sum tests were performed to compare responders and nonresponders.

RESULTS: A total of 235 patients were deemed eligible for the study, and 139 responded (59.1% response rate). Median age at the time of surgery was 27.1 (IQR, 23.0-33.4) years for responders and 26.4 (IQR, 23.1-32.7) years for nonresponders. Nonresponders (n = 96) had a longer postoperative follow-up period than responders (median follow-up, 4.6 [IQR, 3.1-8.6] vs 3.6 [IQR, 2.7-5.3] years, respectively; P = .002). Nonresponders vs responders also had lower rates of depression (42 [44%] vs 94 [68%]; P < .001) and anxiety (42 [44%] vs 97 [70%]; P < .001). No responders or nonresponders requested or underwent a reversal procedure. The median Satisfaction With Decision Scale score was 5.0 (IQR, 5.0-5.0) on a 5-point scale, with higher scores noting higher satisfaction. The median Decision Regret Scale score was 0.0 (IQR, 0.0-0.0) on a 100-point scale, with lower scores noting lower levels of regret. A univariable regression analysis could not be performed to identify characteristics associated with low satisfaction with decision or high decisional regret due to the lack of variation in these responses.

CONCLUSIONS AND RELEVANCE: In this cross-sectional survey study, the results of validated survey instruments indicated low rates of decisional regret and high levels of satisfaction with decision following gender-affirming mastectomy. The lack of dissatisfaction and regret impeded the ability to perform a more complex statistical analysis, highlighting the need for condition-specific instruments to assess decisional regret and satisfaction with decision following gender-affirming surgery.

PMID:37556147 | DOI:10.1001/jamasurg.2023.3352

JAMA Surg. 2023 Aug 9. doi: 10.1001/jamasurg.2023.3333. Online ahead of print.

NO ABSTRACT

PMID:37556145 | DOI:10.1001/jamasurg.2023.3333

JAMA Netw Open. 2023 Aug 1;6(8):e2328121. doi: 10.1001/jamanetworkopen.2023.28121.

ABSTRACT

IMPORTANCE: Patients undergoing spine surgery often experience severe pain. The optimal dosage of pregabalin and gabapentin for pain control and safety in these patients has not been well established.

OBJECTIVE: To evaluate the associations of pain, opioid consumption, and adverse events with different dosages of pregabalin and gabapentin in patients undergoing spine surgery.

DATA SOURCES: PubMed/MEDLINE, Embase, Web of Science, Cochrane library, and Scopus databases were searched for articles until August 7, 2021.

STUDY SELECTION: Randomized clinical trials conducted among patients who received pregabalin or gabapentin while undergoing spine surgery were included.

DATA EXTRACTION AND SYNTHESIS: Two investigators independently performed data extraction following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) reporting guideline. The network meta-analysis was conducted from August 2022 to February 2023 using a random-effects model.

MAIN OUTCOMES AND MEASURES: The primary outcome was pain intensity measured using the Visual Analog Scale (VAS), and secondary outcomes included opioid consumption and adverse events.

RESULTS: Twenty-seven randomized clinical trials with 1861 patients (median age, 45.99 years [range, 20.00-70.00 years]; 759 women [40.8%]) were included in the systematic review and network meta-analysis. Compared with placebo, the VAS pain score was lowest with gabapentin 900 mg per day, followed by gabapentin 1200 mg per day, gabapentin 600 mg per day, gabapentin 300 mg per day, pregabalin 300 mg per day, pregabalin 150 mg per day, and pregabalin 75 mg per day. Additionally, gabapentin 900 mg per day was found to be associated with the lowest opioid consumption among all dosages of gabapentin and pregabalin, with a mean difference of -22.07% (95% CI, -33.22% to -10.92%) for the surface under the cumulative ranking curve compared with placebo. There was no statistically significant difference in adverse events (nausea, vomiting, and dizziness) among all treatments. No substantial inconsistency between direct and indirect evidence was detected for all outcomes.

CONCLUSIONS AND RELEVANCE: These findings suggest that gabapentin 900 mg per day before spine surgery is associated with the lowest VAS pain score among all dosages. In addition, no differences in adverse events were noted among all treatments.

PMID:37556139 | DOI:10.1001/jamanetworkopen.2023.28121

JAMA Cardiol. 2023 Aug 9. doi: 10.1001/jamacardio.2023.2264. Online ahead of print.

ABSTRACT

IMPORTANCE: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest (OHCA). The long-term effect of early coronary angiography on patients with OHCA with possible coronary trigger but no ST-segment elevation remains unclear.

OBJECTIVE: To compare the clinical outcomes of early unselective angiography with the clinical outcomes of a delayed or selective approach for successfully resuscitated patients with OHCA of presumed cardiac origin without ST-segment elevation at 1-year follow-up.

DESIGN, SETTING, AND PARTICIPANTS: The TOMAHAWK trial was a multicenter, international (Germany and Denmark), investigator-initiated, open-label, randomized clinical trial enrolling 554 patients between November 23, 2016, to September 20, 2019. Patients with stable return of spontaneous circulation after OHCA of presumed cardiac origin but without ST-segment elevation on the postresuscitation electrocardiogram were eligible for inclusion. A total of 554 patients were randomized to either immediate coronary angiography after hospital admission or an initial intensive care assessment with delayed or selective angiography after a minimum of 24 hours. All 554 patients were included in survival analyses during the follow-up period of 1 year. Secondary clinical outcomes were assessed only for participants alive at 1 year to account for the competing risk of death.

INTERVENTIONS: Early vs delayed or selective coronary angiography and revascularization if indicated.

MAIN OUTCOMES AND MEASURES: Evaluations in this secondary analysis included all-cause mortality after 1 year, as well as severe neurologic deficit, myocardial infarction, and rehospitalization for congestive heart failure in survivors at 1 year.

RESULTS: A total of 281 patients were randomized to the immediate angiography group and 273 to the delayed or selective group, with a median age of 70 years (IQR, 60-78 years). A total of 369 of 530 patients (69.6%) were male, and 268 of 483 patients (55.5%) had a shockable arrest rhythm. At 1 year, all-cause mortality was 60.8% (161 of 265) in the immediate angiography group and 54.3% (144 of 265) in the delayed or selective angiography group without significant difference between the treatment strategies, trending toward an increase in mortality with immediate angiography (hazard ratio, 1.25; 95% CI, 0.99-1.57; P = .05). For patients surviving until 1 year, the rates of severe neurologic deficit, myocardial infarction, and rehospitalization for congestive heart failure were similar between the groups.

CONCLUSIONS AND RELEVANCE: This study found that a strategy of immediate coronary angiography does not provide clinical benefit compared with a delayed or selective invasive approach for patients 1 year after resuscitated OHCA of presumed coronary cause and without ST-segment elevation.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02750462.

PMID:37556123 | DOI:10.1001/jamacardio.2023.2264

Drug Saf. 2023 Aug 9. doi: 10.1007/s40264-023-01332-1. Online ahead of print.

ABSTRACT

INTRODUCTION: In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine.

OBJECTIVE: We aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population aged ≥5 years from 19 February 2021 through 10 February 2022.

METHODS: Using national electronic health records, the observed rates of AESIs within a risk period (1-21 days) following vaccination were compared with the expected rates based on background data (2014-2019). Standardised incidence ratios (SIRs) were estimated for each AESI with 95% confidence intervals (CIs) using age group-specific background rates. The risk difference was calculated to estimate the excess or reduced number of events per 100,000 persons vaccinated in the risk period.

RESULTS: As of 10 February 2022, 4,277,163 first doses and 4,114,364 second doses of BNT162b2 had been administered to the eligible New Zealand population aged ≥5 years. The SIRs for 11 of the 12 selected AESIs were not statistically significantly increased post vaccination. The SIR (95% CI) for myo/pericarditis following the first dose was 2.3 (1.8-2.7), with a risk difference (95% CI) of 1.3 (0.9-1.8), per 100,000 persons vaccinated, and 4.0 (3.4-4.6), with a risk difference of 3.1 (2.5-3.7), per 100,000 persons vaccinated following the second dose. The highest SIR was 25.6 (15.5-37.5) in the 5-19 years age group, following the second dose of the vaccine, with an estimated five additional myo/pericarditis cases per 100,000 persons vaccinated. A statistically significant increased SIR of single organ cutaneous vasculitis (SOCV) was also observed following the first dose of BNT162b2 in the 20-39 years age group only.

CONCLUSIONS: A statistically significant association between BNT162b2 vaccination and myo/pericarditis was observed. This association has been confirmed internationally. BNT162b2 was not found to be associated with the other AESIs investigated, except for SOCV following the first dose of BNT162b2 in the 20-39 years age group only, providing reassurances around the safety of the vaccine.

PMID:37556109 | DOI:10.1007/s40264-023-01332-1

Int Urol Nephrol. 2023 Aug 9. doi: 10.1007/s11255-023-03733-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Our study aimed to evaluate the performance of Quick Sepsis-related Organ Failure Assessment (qSOFA), Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), Systemic Inflammatory Response Syndrome (SIRS), and Global Research in the Emphysematous Pyelonephritis group (GREMP) in predicting the need of admission in intensive care units (ICU) for emphysematous pyelonephritis (EPN) patient.

PATIENTS AND METHODS: In this retrospective study, we reviewed 70 patients admitted to our department from January 2008 to October 2022. Data on clinical presentation and EPN management were noted. The five scoring systems were calculated by one investigator. Univariate and multivariate analyses were used to assess predictive factors of severe sepsis and mortality. Statistical analysis was made using SPSS version 22.

RESULTS: Mean age was 61.83 years with 65.7% diabetes. As per Huang and Tseng classification, 41 patients had class I EPN, 7 had class II EPN, 8 had class IIIa, 6 class IIIB EPN, and 8 had class IV EPN. Seventeen patients (24.28%) were admitted to ICU with an 18.57 mortality rate. Univariate analysis showed that ICU admission was significantly associated with higher respiration rate and heart rate, lower systolic blood pressure, confusion, CRP, lactate and creatinine serum (p = 0.0001, p = 0.0001, p = 0.001, p = 0.007, p = 0.004, p = 0.001, p = 0.001, respectively). All five scores and Huang and Tseng classification were significantly predictive of admission to ICU. All five scores showed good results under the area curves to predict ICU entry with 0.915, 0.895, 0.968, 0.887, and 0.846 for qSOFA, MEWS score, NEWS score, SIRS, and GREMP score, respectively.

CONCLUSION: NEWS score seemed to be the best performing physiologic score among the five scoring systems studied and may help with biological and radiological findings to quickly identify EPN patients that need intensive care unit.

PMID:37556105 | DOI:10.1007/s11255-023-03733-8

MAGMA. 2023 Aug 9. doi: 10.1007/s10334-023-01112-z. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the reproducibility of radiomics features derived via different pre-processing settings from paired T2-weighted imaging (T2WI) prostate lesions acquired within a short interval, to select the setting that yields the highest number of reproducible features, and to evaluate the impact of disease characteristics (i.e., clinical variables) on features reproducibility.

MATERIALS AND METHODS: A dataset of 50 patients imaged using T2WI at 2 consecutive examinations was used. The dataset was pre-processed using 48 different settings. A total of 107 radiomics features were extracted from manual delineations of 74 lesions. The inter-scan reproducibility of each feature was measured using the intra-class correlation coefficient (ICC), with ICC values > 0.75 considered good. Statistical differences were assessed using Mann-Whitney U and Kruskal-Wallis tests.

RESULTS: The pre-processing parameters strongly influenced the reproducibility of radiomics features of T2WI prostate lesions. The setting that yielded the highest number of features (25 features) with high reproducibility was the relative discretization with a fixed bin number of 64, no signal intensity normalization, and outlier filtering by excluding outliers. Disease characteristics did not significantly impact the reproducibility of radiomics features.

CONCLUSION: The reproducibility of T2WI radiomics features was significantly influenced by pre-processing parameters, but not by disease characteristics. The selected pre-processing setting yielded 25 reproducible features.

PMID:37556085 | DOI:10.1007/s10334-023-01112-z

Pain Ther. 2023 Aug 9. doi: 10.1007/s40122-023-00543-9. Online ahead of print.

ABSTRACT

INTRODUCTION: The evolution of pre- versus postoperative risk factors remains unknown in the development of persistent postoperative pain and opioid use. We identified preoperative versus comprehensive perioperative models of delayed pain and opioid cessation after total joint arthroplasty including time-varying postoperative changes in emotional distress. We hypothesized that time-varying longitudinal measures of postoperative psychological distress, as well as pre- and postoperative use of opioids would be the most significant risk factors for both outcomes.

METHODS: A prospective cohort of 188 patients undergoing total hip or knee arthroplasty at Stanford Hospital completed baseline pain, opioid use, and emotional distress assessments. After surgery, a modified Brief Pain Inventory was assessed daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 1 year. Emotional distress and pain catastrophizing were assessed weekly to 6 months, then monthly thereafter. Stepwise multivariate time-varying Cox regression modeled preoperative variables alone, followed by all perioperative variables (before and after surgery) with time to postoperative opioid and pain cessation.

RESULTS: The median time to opioid and pain cessation was 54 and 152 days, respectively. Preoperative total daily oral morphine equivalent use (hazard ratio-HR 0.97; 95% confidence interval-CI 0.96-0.98) was significantly associated with delayed postoperative opioid cessation in the perioperative model. In contrast, time-varying postoperative factors: elevated PROMIS (Patient-Reported Outcomes Measurement Information System) depression scores (HR 0.92; 95% CI 0.87-0.98), and higher Pain Catastrophizing Scale scores (HR 0.85; 95% CI 0.75-0.97) were independently associated with delayed postoperative pain resolution in the perioperative model.

CONCLUSIONS: These findings highlight preoperative opioid use as a key determinant of delayed postoperative opioid cessation, while postoperative elevations in depressive symptoms and pain catastrophizing are associated with persistent pain after total joint arthroplasty providing the rationale for continued risk stratification before and after surgery to identify patients at highest risk for these distinct outcomes. Interventions targeting these perioperative risk factors may prevent prolonged postoperative pain and opioid use.

PMID:37556071 | DOI:10.1007/s40122-023-00543-9

Environ Sci Pollut Res Int. 2023 Aug 9. doi: 10.1007/s11356-023-29051-1. Online ahead of print.

ABSTRACT

The research objective of this research paper is to examine the relationships between organizational commitment to emission trading schemes, artificial intelligence, and climate entrepreneurship, as well as their impact on sustainable performance, i.e., environmental and organizational performance in organizations. This study aims to identify the key drivers and barriers to the adoption of these factors and to understand how they influence environmental and organizational performance. The study utilizes a cause-and-effect design on the sampled size of 387 subjects and employs the Smart PLS version 4.0 statistical tool to estimate the interactions between all constructs in the structural equation modeling. The research questions aim to explore the key drivers and barriers to the adoption of these factors in organization and their impact on sustainable performance, i.e., environmental and organizational performance. The study hypothesizes that organizational commitment to emission trading schemes, AI, and climate entrepreneurship has a positive impact on sustainable performances such as environmental and organizational performance. The findings suggest that attitudes toward AI and emission trading schemes have a direct impact on climate entrepreneurship, environmental performance, and organizational performance. By considering these factors together, the study seeks to uncover the synergistic effects and potential interactions between them and sheds light on their combined influence on environmental and organizational performance. Organizations can enhance environmental and organizational performance by prioritizing their attitudes toward emission trading schemes, AI, and climate entrepreneurship through resource allocation, technology investment, and fostering a climate entrepreneurship mindset. The research concludes that businesses that demonstrate high organizational commitment, positive attitude toward the ETS, and a focus on climate entrepreneurship experiences improved environmental and organizational performance.

PMID:37556056 | DOI:10.1007/s11356-023-29051-1