Nevin Manimala

Arq Bras Cardiol. 2023 Aug 7;120(7):e20220543. doi: 10.36660/abc.20220543. eCollection 2023.

ABSTRACT

BACKGROUND: In the pediatric population, syncope is mainly from vasovagal (VVS) origin. Its evaluation must be done by clinical methods, and the tilt test (TT) can contribute to the diagnosis.

OBJECTIVES: To analyze the clinical profile, Calgary and modified Calgary scores, response to TT and heart rate variability (HRV) of patients aged ≤ 18 years with presumed VVS. To compare the variables between patients with positive and negative responses to TT.

METHOD: Observational and prospective study, with 73 patients aged between 6 and 18 years, submitted to clinical evaluation and calculation of scores without previous knowledge of the TT. It was done at 70º under monitoring for HRV analysis. P-value < 0.05 was the statistical significance criterion.

RESULTS: Median age was 14.0 years; 52% of participants were female, 72 had Calgary ≥ -2 (mean 1.80), and 69 had modified Calgary ≥ -3 (mean 1.38). Prodromes were observed in 59 patients, recurrence in 50 and trauma in 19. The response to TT was positive in 54 participants (49 vasovagal, with 39 vasodepressor responses), with an increase in the low frequency (LF) component and a decrease in the high frequency (HF) component (p < 0,0001). In the supine position, LF was 33.6 in females and 47.4 in normalized units for males (p = 0.02). When applying the operating characteristic curve for positive TT, there was no statistical significance for HRV and scores.

CONCLUSION: Most children and adolescents with a presumed diagnosis of VVS presented a typical clinical scenario, with a Calgary score ≥ -2, and a predominant vasodepressor response to TT. Greater sympathetic activation was observed in the supine position in males. Calgary scores and sympathetic activation did not predict the response to TT.

PMID:37556654 | DOI:10.36660/abc.20220543

JMIR Res Protoc. 2023 Aug 9;12:e50231. doi: 10.2196/50231.

ABSTRACT

BACKGROUND: Reducing avoidable nursing home (NH)-to-hospital transfers of residents with Alzheimer disease or a related dementia (ADRD) has become a national priority due to the physical and emotional toll it places on residents and the high costs to Medicare and Medicaid. Technologies supporting the use of clinical text messages (TMs) could improve communication among health care team members and have considerable impact on reducing avoidable NH-to-hospital transfers. Although text messaging is a widely accepted mechanism of communication, clinical models of care using TMs are sparsely reported in the literature, especially in NHs. Protocols for assessing technologies that integrate TMs into care delivery models would be beneficial for end users of these systems. Without evidence to support clinical models of care using TMs, users are left to design their own methods and protocols for their use, which can create wide variability and potentially increase disparities in resident outcomes.

OBJECTIVE: Our aim is to describe the protocol of a study designed to understand how members of the multidisciplinary team communicate using TMs and how salient and timely communication can be used to avert poor outcomes for NH residents with ADRD, including hospitalization.

METHODS: This project is a secondary analysis of data collected from a Centers for Medicare & Medicaid Services (CMS)-funded demonstration project designed to reduce avoidable hospitalizations for long-stay NH residents. We will use two data sources: (1) TMs exchanged among the multidisciplinary team across the 7-year CMS study period (August 2013-September 2020) and (2) an adapted acute care transfer tool completed by advanced practice registered nurses to document retrospective details about NH-to-hospital transfers. The study is guided by an age-friendly model of care called the 4Ms (What Matters, Medications, Mentation, and Mobility) framework. We will use natural language processing, statistical methods, and social network analysis to generate a new ontology and to compare communication patterns found in TMs occurring around the time NH-to-hospital transfer decisions were made about residents with and without ADRD.

RESULTS: After accounting for inclusion and exclusion criteria, we will analyze over 30,000 TMs pertaining to over 3600 NH-to-hospital transfers. Development of the 4M ontology is in progress, and the 3-year project is expected to run until mid-2025.

CONCLUSIONS: To our knowledge, this project will be the first to explore the content of TMs exchanged among a multidisciplinary team of care providers as they make decisions about NH-to-hospital resident transfers. Understanding how the presence of evidence-based elements of high-quality care relate to avoidable hospitalizations among NH residents with ADRD will generate knowledge regarding the future scalability of behavioral interventions. Without this knowledge, NHs will continue to rely on ineffective and outdated communication methods that fail to account for evidence-based elements of age-friendly care.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50231.

PMID:37556199 | DOI:10.2196/50231

JMIR Form Res. 2023 Aug 9;7:e46841. doi: 10.2196/46841.

ABSTRACT

BACKGROUND: Infectious disease-specific health literacy (IDSHL) has become an important determinant of infectious disease incidence. It can not only reduce the incidence of re-emerging infectious diseases, but also effectively prevent the emergence of new infectious diseases such as COVID-19. WeChat, as a new media, has been proven to greatly reduce the chance of infectious diseases spreading from person to person, especially in case of respiratory infections. However, there is currently no concrete health education invention program to improve IDSHL using a WeChat public account.

OBJECTIVE: The aims of this study were as follows: (1) to determine the IDSHL of the population in Zhejiang, China; (2) to develop a health education program for the improvement of IDSHL using a WeChat public account; and (3) to evaluate the effectiveness of the health education program that was implemented in the prevention of infectious disease outbreaks.

METHODS: We used a standardized questionnaire, which consisted of 28 closed-ended questions, to measure the level and score of IDSHL before and after intervention. A multiple-stage stratified random sampling technique was used to select study participants from Zhejiang province in China, who were further divided randomly into 2 groups: the intervention and control groups. From July 2014 to January 2015, a WeChat-based health education intervention program was carried out on the intervention group. Standard descriptive statistics and chi-square and t tests were conducted to analyze the data.

RESULTS: A total of 3001 residents participated in the baseline survey of this study. At baseline, participant IDSHL rates were 73.29% and 72.12% for the intervention and control groups, respectively (Χ²₁=0.5; P=.50). After 7 months of intervention, 9.90% (297/3001) of participants dropped out of the study. Of the lost participants, 119 were from the intervention group and 178 were from the control group. There were significant differences between follow-up and lost participants with respect to age (P=.04), marital status (P=.02) and occupations (P=.002). After intervention, the intervention group scores in the different domains were higher than those in the control group (infectious disease-related knowledge, prevention, management, or treatment, identification of pathogens and infection sources, and cognitive ability). There were significant improvements in the IDSHL of participants in both the intervention and control groups (Χ²₁=135.9; P<.001 vs Χ²₁=9.1; P=.003), and there was a greater change in the IDSHL among the intervention group participants than among the control group participants (1230/1359, 90.51% vs 1038/1359, 77.17%).

CONCLUSIONS: The health education intervention program using a WeChat public account proved to be an effective, feasible, and well-accepted means to improve the IDSHL of the general population. In the future, this health education intervention program can be used as a reference for prevention and treatment of infectious diseases.

PMID:37556189 | DOI:10.2196/46841

J Med Internet Res. 2023 Aug 9;25:e45240. doi: 10.2196/45240.

ABSTRACT

BACKGROUND: People with acquired brain injury (ABI) experience communication breakdown in everyday interactions many years after injury, negatively impacting social and vocational relationships. Communication partner training (CPT) is a recommended intervention approach in communication rehabilitation after ABI. Access to long-term services is essential, both in rural and remote locations. Digital health has potential to overcome the challenges of travel and improve cost efficiencies, processes, and clinical outcomes.

OBJECTIVE: We aimed to collaboratively develop a novel, multimodal web-based CPT intervention (convers-ABI-lity) with key stakeholders and evaluate its feasibility for improving conversation skills after brain injury.

METHODS: This mixed methods study consisted of 3 key stages guided by the Integrate, Design, Assess, and Share (IDEAS) framework for developing effective digital health interventions. Stage 1 included the integration of current end-user needs and perspectives with key treatment and theoretical components of existing evidence-based interventions, TBI Express and TBIconneCT. Stage 2 included the iterative design of convers-ABI-lity with feedback from end-user interviews (n=22) analyzed using content analysis. Participants were individuals with ABI, family members, health professionals, and paid support workers. Stage 3 included the evaluation of the feasibility through a proof-of-concept study (n=3). A total of 3 dyads (a person with ABI and their communication partner [CP]) completed 7 weeks of convers-ABI-lity, guided by a clinician. The outcome measures included blinded ratings of conversation samples and self-report measures. We analyzed postintervention participant interviews using content analysis to inform further intervention refinement and development.

RESULTS: Collaborative and iterative design and development during stages 1 and 2 resulted in the development of convers-ABI-lity. Results in stage 3 indicated positive changes in the blinded ratings of conversation samples for the participants with traumatic brain injury and their CPs. Statistically reliable positive changes were also observed in the self-report measures of social communication skills and quality of life. Intervention participants endorsed aspects of convers-ABI-lity, such as its complementary nature, self-guided web-based modules, clinician sessions, engaging content, and novel features. They reported the intervention to be relevant to their personal experience with cognitive-communication disorders.

CONCLUSIONS: This study presents the outcome of using the IDEAS framework to guide the development of a web-based multimodal CPT intervention with input from key stakeholders. The results indicate promising outcomes for improving the conversation skills of people with ABI and their CPs. Further evaluation of intervention effectiveness and efficacy using a larger sample size is required.

PMID:37556179 | DOI:10.2196/45240

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