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Nevin Manimala Statistics

Prehospital Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest: A Systematic Review and Meta-Analysis

J Cardiothorac Vasc Anesth. 2022 Dec 15:S1053-0770(22)00896-5. doi: 10.1053/j.jvca.2022.12.004. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the available published evidence of the effects of extracorporeal cardiopulmonary resuscitation (ECPR) in the prehospital setting on clinical outcomes in patients with out-of-hospital cardiac arrest.

DESIGN: A systematic review and meta-analysis designed according to the Preferred Reporting Items for Systematic Reviews an Meta-Analyses guidelines.

SETTING: In the prehospital setting.

PARTICIPANTS: All randomized control trials (RCTs) and observational trials using pre-hospital ECPR in adult patients (>17 years).

INTERVENTIONS: Prehospital ECPR.

MEASUREMENTS AND MAIN RESULTS: The study authors searched Medline, Embase, and PUBMED for all RCTs and observational trials. The studies were assessed for clinical, methodologic, and statistical heterogeneity. The primary outcome was survival at hospital discharge. The study outcomes were aggregated using random-effects meta-analysis of means or proportions as appropriate. The Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the quality of evidence. Four studies were included, with a total of 222 patients receiving prehospital ECPR (mean age = 51 years [95% CI 44-57], 81% of patients were male (CI 74-87), and 60% patients had a cardiac cause for their arrest (95% CI 43-76). Overall survival at discharge was 23.4% (95% CI 15.5-33.7; I2 = 62%). The pooled low-flow time was 61.1 minutes (95% CI 45.2-77.0; I2 = 97%). The quality of evidence was assessed to be low, and the overall risk of bias was assessed to be serious, with confounding being the primary source of bias.

CONCLUSION: No definitive conclusions can be made as to the efficacy of prehospital ECPR in refractory cardiac arrest. Higher quality evidence is required.

PMID:36641307 | DOI:10.1053/j.jvca.2022.12.004

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Nevin Manimala Statistics

A real-world retrospective analysis of the management of metastatic castrate-resistant prostate cancer in Ontario, Canada from 2010 – 2018

Urol Oncol. 2023 Jan 12:S1078-1439(22)00482-3. doi: 10.1016/j.urolonc.2022.11.019. Online ahead of print.

ABSTRACT

PURPOSE: We sought to quantify mCRPC patient treatment patterns and survival across multiple lines of therapy after prior androgen-receptor-axis-targeted therapy (ARAT) failure.

METHODS: Individuals diagnosed with prostate cancer between 2010 and 2018 were identified in the Ontario Cancer Registry (OCR). An algorithm was created to identify patients with mCRPC that was aligned to Prostate Cancer Clinical Trials Working Group 3 criteria (PCWG3) and validated with Canadian clinical experts. In the mCRPC setting, treatment patterns were assessed by line of therapy, and survival was calculated from treatment initiation until death or lost to follow-up.

RESULTS: 64,484 men were diagnosed withprostate cancer in Ontario between 2010 and 2018with 5,588 men assessed to have mCRPC and 2,970 (53%) of those received first-line systemic treatment. Across the first-, second- and third-line of therapy, ARATs (abiraterone and enzalutamide) were the most used therapies. Survival for mCRPC patients treated with ARATs in first-, second- and third-line were 13.0 (95% CI, 11.6 – 14.5), 11.5 (95% CI, 10.1 – 13.4) and 8.9 (95% CI, 7.4 – 10.2) months, respectively. Survival for mCRPC patients treated with taxanes in first, second- and third-line were 16.7 (95% CI, 14.8 – 18.0), 11.3 (95% CI, 10.1 – 12.5) and 7.8 (95% CI, 6.5 – 10.6) months, respectively. No statistical difference in overall survival was found between taxanes and ARATs.

CONCLUSION: In this analysis of a large retrospective cohort of Canadian men with mCRPC, we found that survival in patients treated with ARATs and taxanes was fairly similar across all lines of therapy. Importantly, this trend was maintained in ARAT-exposed patients, where sequential ARAT and taxanes offered similar survival. These data may help inform optimal sequencing of therapies in mCRPC.

PMID:36641303 | DOI:10.1016/j.urolonc.2022.11.019

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Nevin Manimala Statistics

Validation and bifactor structure of the French Adult ADHD Symptoms Rating Scale v1.1 (ASRS)

Encephale. 2023 Jan 12:S0013-7006(22)00274-3. doi: 10.1016/j.encep.2022.11.007. Online ahead of print.

ABSTRACT

BACKGROUND: Three scoring methods for the widely available Adult ADHD Symptoms Rating Scale v1.1 (ASRS) have been proposed to screen for ADHD, but these three methods have rarely been compared against formal clinical diagnoses. We aimed to validate the French version of the ASRS against a clinical interview using DSM-IV and DSM-5 diagnostic algorithms.

METHODS: One hundred five adults from a convenience sample were evaluated with the ASRS and the DIVA 2.0, using both DSM-IV and DSM-5 criteria. We used Confirmatory Factor Analysis to investigate the underlying structure of the ASRS. Sensitivity, specificity, and classification accuracy were compared between the rating algorithms of the ASRS.

RESULTS: The full score method had worse predictive performance than the Screener and the 2-stage scoring method. All characteristics of the three scoring methods for the ASRS were worse when applying DSM-5 criteria. The best-fitting structure was a bi-factor model with a general ADHD factor and three specific factors.

CONCLUSIONS: ADHD was best conceived as a one-dimensional construct. The 2-stage scoring method superseded the Screener with comparable sensitivity and specificity.

PMID:36641267 | DOI:10.1016/j.encep.2022.11.007

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Nevin Manimala Statistics

Impact of Race and Ethnicity on Emergency Medical Services Administration of Opioid Pain Medications for Injured Children

J Emerg Med. 2023 Jan 12:S0736-4679(22)00578-9. doi: 10.1016/j.jemermed.2022.10.011. Online ahead of print.

ABSTRACT

BACKGROUND: Treatment with analgesics for injured children is often not provided or delayed during prehospital transport.

OBJECTIVE: Our aim was to evaluate racial and ethnic disparities with the use of opioids during transport of injured children.

METHODS: We conducted a prospective study of injured children transported to 1 of 10 emergency departments from July 2019 to April 2020. Emergency medical services (EMS) providers were surveyed about prehospital pain interventions during transport. Our primary outcome was the use of opioids. We performed multivariate regression analyses to evaluate the association of patient demographic characteristics (race, ethnicity, age, and gender), presence of a fracture, EMS provider type (Advanced Life Support [ALS] or non-ALS) and experience (years), and study site with the use of opioids.

RESULTS: We enrolled 465 patients; 19% received opioids during transport. The adjusted odds ratios (AORs) for Black race and Hispanic ethnicity were 0.5 (95% CI 0.2-1.2) and 0.4 (95% CI 0.2-1.3), respectively. The presence of a fracture (AOR 17.0), ALS provider (AOR 5.6), older patient age (AOR 1.1 for each year), EMS provider experience (AOR 1.1 for each year), and site were associated with receiving opioids.

CONCLUSIONS: There were no statistically significant associations between race or ethnicity and use of opioids for injured children. The presence of a fracture, ALS provider, older patient age, EMS provider experience, and site were associated with receiving opioids.

PMID:36641254 | DOI:10.1016/j.jemermed.2022.10.011

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Nevin Manimala Statistics

The Effects of Anterior Palatoplasty and Functional Expansion Sphincter Pharyngoplasty on Voice Quality in Patients with Obstructive Sleep Apnea

J Voice. 2023 Jan 12:S0892-1997(22)00385-X. doi: 10.1016/j.jvoice.2022.11.032. Online ahead of print.

ABSTRACT

OBJECTIVES: We aimed to examine the effects of anterior palatoplasty (AP) and functional expansion sphincter pharyngoplasty (FESP) on voice quality in patients with OSAS and to compare them with each other.

MERHODS: The study included 380 patients who came to the Otorhinolaryngology Clinic of our hospital with symptoms of snoring and sleep apnea between April 2020 and April 2022 and were referred to the sleep laboratory for polysomnography (PSG).Forty patients who met the study criteria and underwent AP and 26 patients who underwent FESP were included in the study. All surgeries were performed under general anesthesia by the same otolaryngologist within 1 month at the latest after sleep endoscopy. Acoustic voice analysis was performed using the Praat voice analysis program preoperatively and postoperatively at 6 months. F0, jitter, shimmer, and NHR (noise-to-harmonic ratio) were compared between the groups pre and postoperatively.

RESULTS: There were 20 females and 20 males in the AP group, 12 females and 14 males in the FESP group, There was no statistically significant difference in sex distribution between the groups (P = 0.952). The difference between the preop and postop F0, jitter, shimmer, and NHR in both the AP and FESP groups was statistically significant (P < 0.01). After AP and FESP surgeries, F0 values ​​increased, jitter, shimmer and NHR values ​​decreased (P < 0.01).F0, jitter, shimmer, and NHR changes were the greatest in the FESP group.(P < 0.01).

CONCLUSION: Positive changes in F0, jitter, shimmer, and NHR were greatest in the FESP group significantly. FESP surgery affects voice quality more than AP surgery in patients with OSAS.

PMID:36641251 | DOI:10.1016/j.jvoice.2022.11.032

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Nevin Manimala Statistics

Assessing the effects of pharmacist education on colorectal cancer screening and access to a stool-based DNA test

J Am Pharm Assoc (2003). 2022 Dec 20:S1544-3191(22)00392-2. doi: 10.1016/j.japh.2022.11.012. Online ahead of print.

ABSTRACT

BACKGROUND: Colorectal cancer is the third most common cancer and is anticipated to cause 52,580 deaths in 2022 in the United States. Despite the effectiveness of colorectal cancer screening (CRCS), only 74% of adults eligible for CRCS complete the screening. Community pharmacists are well positioned to provide preventive care education and recommendations to the general population.

OBJECTIVES: This study aimed to evaluate overall participants’ knowledge, perceptions, and barriers on CRCS before and after receiving pharmacist-led education in the outpatient, community pharmacy setting and to assess the impact of pharmacist intervention on screening uptake with the stool-based DNA test.

METHODS: A 16-item prequestionnaire/postquestionnaire was administered by clinical pharmacists in a grocery store pharmacy chain in the Kansas City area. The questionnaire assessed participants’ knowledge, perceptions, barriers, CRCS intentions, and demographics. After completing the prequestionnaire, participants received verbal and written education. For those participants interested in the stool-based DNA test, a facsimile transmission was sent to the participant’s provider. The postquestionnaire was administered by the pharmacist coach at visit 2 6 to 10 weeks later. Participant demographics were assessed using descriptive statistics. Wilcoxon signed rank test was used to assess prechanges/postchanges in perceptions, awareness, and knowledge. We reported the stool-based DNA test completion rate as an overall percentage.

RESULTS: Participants’ knowledge of CRCS reached statistical significance after pharmacist-led education (score 4.5-6, P = 0.003). There was no change in perception pre/post. The 3 most common reported barriers were cost of screening, not being concerned with colon cancer, and lack of follow-up from a physician. Of 42 participants, 23 (54.8%) were indicated for CRCS and 4 (17%) completed screening during the study.

CONCLUSION: Not all eligible participants completed CRCS, but pharmacists improved participants’ knowledge of CRCS.

PMID:36641246 | DOI:10.1016/j.japh.2022.11.012

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Nevin Manimala Statistics

Type D personality as a risk factor for adverse outcome in patients with cardiovascular disease: an individual patient data meta-analysis

Psychosom Med. 2023 Jan 16. doi: 10.1097/PSY.0000000000001164. Online ahead of print.

ABSTRACT

OBJECTIVE: Type D personality, a joint tendency toward negative affectivity (NA) and social inhibition (SI), has been linked to adverse events in patients with heart disease, though with inconsistent findings. Here, we apply an individual patient-data meta-analysis to data from 19 prospective cohort studies (N = 11151), to investigate the prediction of adverse outcomes by Type D personality in acquired cardiovascular disease (CVD) patients.

METHOD: For each outcome (all-cause mortality, cardiac mortality, myocardial infarction (MI), coronary artery bypass grafting, percutaneous coronary intervention, major adverse cardiac event (MACE), any adverse event), we estimated Type D’s prognostic influence and the moderation by age, sex, and disease type.

RESULTS: In CVD patients, evidence for a Type D effect in terms of the Bayes factor (BF) was strong for MACE (BF = 42.5; OR = 1.14) and any adverse event (BF = 129.4; OR = 1.15). Evidence for the null hypothesis was found for all-cause mortality (BF = 45.9; OR = 1.03), cardiac mortality (BF = 23.7; OR = 0.99) and MI (BF = 16.9; OR = 1.12), suggesting Type D had no effect on these outcomes. This evidence was similar in the subset of coronary artery disease (CAD) patients, but inconclusive for heart failure (HF) patients. Positive effects were found for NA on cardiac- and all-cause mortality, the latter being more pronounced in males than females.

CONCLUSION: Across 19 prospective cohort studies, Type D predicts adverse events in CAD patients, while evidence in HF patients was inconclusive. In both CAD and HF patients, we found evidence for a null effect of Type D on cardiac- and all-cause mortality.

PMID:36640440 | DOI:10.1097/PSY.0000000000001164

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Nevin Manimala Statistics

Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study

Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.

ABSTRACT

BACKGROUND: Invasive cardiac catheterization (CC) temporarily increases pain, discomfort, and anxiety. Procedural sedation is deployed to mitigate these symptoms, though practice varies. Research evaluating peri-procedural patient-reported outcomes is lacking.

METHODS AND RESULTS: We randomized 175 patients undergoing CC to short interval ([SI] group, <6 min) or long interval ([LI] group, ≥6 min) time intervals between initial intravenous sedation and local anesthetic administration. Outcomes included: (1) total pain medication use, (2) patient-reported and behaviorally assessed pain and (3) patient satisfaction during outpatient CC. Generalized linear mixed effect models were used to evaluate the impact of treatment time interval on total medication utilization, pain, and satisfaction. Among enrollees the mean age was 62 (standard deviation [SD] = 13.4), a majority were male (66%), white (74%), and overweight (mean body mass index = 28.5 [SD = 5.6]). Total pain medication use did not vary between treatment groups (p = 0.257), with no difference in total fentanyl (p = 0.288) or midazolam (p = 0.292). Post-treatment pain levels and nurse-observed pain were not statistically significant between groups (p = 0.324 & p = 0.656, respectively. No significant differences with satisfaction with sedation were found between the groups (p = 0.95) Patient-reported pain, satisfaction and nurse-observed measures of pain did not differ, after adjustment for demographic and procedural factors. Analyses of treatment effect modification revealed that postprocedure self-reported pain levels varied systematically between individuals undergoing percutaneous coronary intervention (PCI) (SI = 2.2 [0.8, 3.6] vs. LI = 0.7 [-0.6, 2.0]) compared with participants not undergoing PCI (SI = 0.4 [-0.8, 1.7] vs. LI = 0.7 [-0.3, 1.6]) (p = 0.043 for interaction).

CONCLUSION: No consistent treatment differences were found for total medication dose, pain, or satisfaction regardless of timing between sedation and local anesthetic. Treatment moderations were seen for patients undergoing PCI. Further investigation of how procedural and individual factors impact the patient experience during CC is needed.

PMID:36640418 | DOI:10.1002/ccd.30535

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Nevin Manimala Statistics

Impact of mental disorders on clinical outcomes of physical diseases: an umbrella review assessing population attributable fraction and generalized impact fraction

World Psychiatry. 2023 Feb;22(1):86-104. doi: 10.1002/wps.21068.

ABSTRACT

Empirical evidence indicates a significant bidirectional association between mental disorders and physical diseases, but the prospective impact of men-tal disorders on clinical outcomes of physical diseases has not been comprehensively outlined. In this PRISMA- and COSMOS-E-compliant umbrella review, we searched PubMed, PsycINFO, Embase, and Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, up to March 15, 2022, to identify systematic reviews with meta-analysis that examined the prospective association between any mental disorder and clinical outcomes of physical diseases. Primary outcomes were disease-specific mortality and all-cause mortality. Secondary outcomes were disease-specific incidence, functioning and/or disability, symptom severity, quality of life, recurrence or progression, major cardiac events, and treatment-related outcomes. Additional inclusion criteria were further applied to primary studies. Random effect models were employed, along with I2 statistic, 95% prediction intervals, small-study effects test, excess significance bias test, and risk of bias (ROBIS) assessment. Associations were classified into five credibility classes of evidence (I to IV and non-significant) according to established criteria, complemented by sensitivity and subgroup analyses to examine the robustness of the main analysis. Statistical analysis was performed using a new package for conducting umbrella reviews (https://metaumbrella.org). Population attributable fraction (PAF) and generalized impact fraction (GIF) were then calculated for class I-III associations. Forty-seven systematic reviews with meta-analysis, encompassing 251 non-overlapping primary studies and reporting 74 associations, were included (68% were at low risk of bias at the ROBIS assessment). Altogether, 43 primary outcomes (disease-specific mortality: n=17; all-cause mortality: n=26) and 31 secondary outcomes were investigated. Although 72% of associations were statistically significant (p<0.05), only two showed convincing (class I) evidence: that between depressive disorders and all-cause mortality in patients with heart failure (hazard ratio, HR=1.44, 95% CI: 1.26-1.65), and that between schizophrenia and cardiovascular mortality in patients with cardiovascular diseases (risk ratio, RR=1.54, 95% CI: 1.36-1.75). Six associations showed highly suggestive (class II) evidence: those between depressive disorders and all-cause mortality in patients with diabetes mellitus (HR=2.84, 95% CI: 2.00-4.03) and with kidney failure (HR=1.41, 95% CI: 1.31-1.51); that between depressive disorders and major cardiac events in patients with myocardial infarction (odds ratio, OR=1.52, 95% CI: 1.36-1.70); that between depressive disorders and dementia in patients with diabetes mellitus (HR=2.11, 95% CI: 1.77-2.52); that between alcohol use disorder and decompensated liver cirrhosis in patients with hepatitis C (RR=3.15, 95% CI: 2.87-3.46); and that between schizophrenia and cancer mortality in patients with cancer (standardized mean ratio, SMR=1.74, 95% CI: 1.41-2.15). Sensitivity/subgroup analyses confirmed these results. The largest PAFs were 30.56% (95% CI: 27.67-33.49) for alcohol use disorder and decompensated liver cirrhosis in patients with hepatitis C, 26.81% (95% CI: 16.61-37.67) for depressive disorders and all-cause mortality in patients with diabetes mellitus, 13.68% (95% CI: 9.87-17.58) for depressive disorders and major cardiac events in patients with myocardial infarction, 11.99% (95% CI: 8.29-15.84) for schizophrenia and cardiovascular mortality in patients with cardiovascular diseases, and 11.59% (95% CI: 9.09-14.14) for depressive disorders and all-cause mortality in patients with kidney failure. The GIFs confirmed the preventive capacity of these associations. This umbrella review demonstrates that mental disorders increase the risk of a poor clinical outcome in several physical diseases. Prevention targeting mental disorders – particularly alcohol use disorders, depressive disorders, and schizophrenia – can reduce the incidence of adverse clinical outcomes in people with physical diseases. These findings can inform clinical practice and trans-speciality preventive approaches cutting across psychiatric and somatic medicine.

PMID:36640414 | DOI:10.1002/wps.21068

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The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents

World Psychiatry. 2023 Feb;22(1):48-74. doi: 10.1002/wps.21056.

ABSTRACT

Despite considerable progress in pharmacotherapy over the past seven decades, many mental disorders remain insufficiently treated. This situation is in part due to the limited knowledge of the pathophysiology of these disorders and the lack of biological markers to stratify and individualize patient selection, but also to a still restricted number of mechanisms of action being targeted in monotherapy or combination/augmentation treatment, as well as to a variety of challenges threatening the successful development and testing of new drugs. In this paper, we first provide an overview of the most promising drugs with innovative mechanisms of action that are undergoing phase 2 or 3 testing for schizophrenia, bipolar disorder, major depressive disorder, anxiety and trauma-related disorders, substance use disorders, and dementia. Promising repurposing of established medications for new psychiatric indications, as well as variations in the modulation of dopamine, noradrenaline and serotonin receptor functioning, are also considered. We then critically discuss the clinical trial parameters that need to be considered in depth when developing and testing new pharmacological agents for the treatment of mental disorders. Hurdles and perils threatening success of new drug development and testing include inadequacy and imprecision of inclusion/exclusion criteria and ratings, sub-optimally suited clinical trial participants, multiple factors contributing to a large/increasing placebo effect, and problems with statistical analyses. This information should be considered in order to de-risk trial programmes of novel agents or known agents for novel psychiatric indications, increasing their chances of success.

PMID:36640403 | DOI:10.1002/wps.21056