Tag: statistics

J Hosp Infect. 2024 May 31:S0195-6701(24)00193-2. doi: 10.1016/j.jhin.2024.04.028. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence were mixed regarding the effect of topical vancomycin (VCM) powder in reducing surgical site infection (SSI).

AIM: To clarify the effect of topical VCM powder for the prevention of in major orthopaedic surgeries.

METHODS: The MEDLINE, Embase, CENTRAL, ICTRP, and ClinicalTrials.gov databases were searched from their inception to 25 September 2023. We included randomised controlled trials comparing topical VCM powder and controls for the prevention of SSI in major orthopaedic surgeries. Two reviewers independently screened the title and abstract and extracted relevant data, followed by the assessment of the risk of bias and the certainty of the evidence. Main outcome measure were Overall SSI, reoperation, and adverse events. Summary results were obtained using random-effects meta-analysis. We performed trial sequential analysis (TSA).

FINDINGS: Eight randomised controlled trials provided data on 4,307 participants. VCM powder showed no difference in reducing overall SSI. The cumulative number of patients did not exceed the required information size of 19,233 in our TSA, and the Z-curves did not cross the trial sequential monitoring or futility boundary, suggesting an inconclusive result of the meta-analysis. No difference was found for reoperation. Among SSI, VCM powder showed statistically significant difference in reducing gram-positive cocci SSI. However, the certainty of this evidence was very low.

CONCLUSIONS: This systematic review and meta-analysis suggests inconclusive results regarding the effect of VCM powder in reducing SSI in major orthopaedic surgeries. Further trials using rigorous methodologies are required to elucidate the effect of this intervention.

PMID:38825190 | DOI:10.1016/j.jhin.2024.04.028

Rev Esp Anestesiol Reanim (Engl Ed). 2024 May 31:S2341-1929(24)00101-X. doi: 10.1016/j.redare.2024.05.006. Online ahead of print.

ABSTRACT

PURPOSE: To demonstrate the utility of machine learning models for predicting difficult airways using clinical and ultrasound parameters.

METHODS: This is a prospective non-consecutive cohort of patients undergoing elective surgery. We collected as predictor variables age, sex, BMI, OSA, Mallampatti, thyromental distance, bite test, cervical circumference, cervical ultrasound measurements, and Cormack-Lehanne class after laryngoscopy. We univariate analyzed the relationship of the predictor variables with the Cormack-Lehanne class to design machine learning models by applying the random forest technique with each predictor variable separately and in combination. We found each design’s AUC-ROC, sensitivity, specificity, and positive and negative predictive values.

RESULTS: We recruited 400 patients. Cormack-Lehanne patients ≥ III had higher age, BMI, cervical circumference, Mallampati class membership ≥ III, and bite test ≥ II and their ultrasound measurements were significantly higher. Machine learning models based on physical examination obtained better AUC-ROC values than ultrasound measurements but without reaching statistical significance. The combination of physical variables that we call the “Classic Model” achieved the highest AUC-ROC value among all the models [0.75 (0.67-0.83)], this difference being statistically significant compared to the rest of the ultrasound models.

CONCLUSIONS: The use of machine learning models for diagnosing VAD is a real possibility, although it is still in a very preliminary stage of development.

CLINICAL REGISTRY: ClinicalTrials.gov: NCT04816435.

PMID:38825182 | DOI:10.1016/j.redare.2024.05.006

Brain Res. 2024 May 31:149049. doi: 10.1016/j.brainres.2024.149049. Online ahead of print.

ABSTRACT

BACKGROUND: Previous studies have revealed structural brain abnormalities in individuals with depression, but the causal relationship between depression and brain structure remains unclear.

METHODS: A genetic correlation analysis was conducted using summary statistics from the largest genome-wide association studies for depression (N = 674,452) and 1,265 brain structural imaging-derived phenotypes (IDPs, N = 33,224). Subsequently, a bidirectional two-sample Mendelian Randomization (MR) approach was employed to explore the causal relationships between depression and the IDPs that showed genetic correlations with depression. The main MR results were obtained using the inverse variance weighted (IVW) method, and other MR methods were further employed to ensure the reliability of the findings.

RESULTS: Ninety structural IDPs were identified as being genetically correlated with depression and were included in the MR analyses. The IVW MR results indicated that reductions in the volume of several brain regions, including the bilateral subcallosal cortex, right medial orbitofrontal cortex, and right middle-posterior part of the cingulate cortex, were causally linked to an increased risk of depression. Additionally, decreases in surface area of the right middle temporal visual area, right middle temporal cortex, right inferior temporal cortex, and right middle-posterior part of the cingulate cortex were causally associated with a heightened risk of depression. Validation and sensitivity analyses supported the robustness of these findings. However, no evidence was found for a causal effect of depression on structural IDPs.

CONCLUSIONS: Our findings reveal the causal influence of specific brain structures on depression, providing evidence to consider brain structural changes in the etiology and treatment of depression.

PMID:38825161 | DOI:10.1016/j.brainres.2024.149049

Photodiagnosis Photodyn Ther. 2024 May 31:104226. doi: 10.1016/j.pdpdt.2024.104226. Online ahead of print.

ABSTRACT

BACKGROUND: Vulvar lichen sclerosus (VLS) is often associated with irritable symptoms of itching, burning pain and can lead to scarring, architectural changes and sexual dysfunction as well as a decline in quality of life.The etiology of the disease is unknown. This study sought to assess the therapeutic effects of Photodynamic Therapy (PDT) in VLS, and improvment of patient quality of life and sexual funtion.

METHODS: From January 2022 to April 2023, a total of 65 patients with vulvar sclerosi (VLS) were treated with PDT in our hospital. All 65 patients were divided into two groups: early-stage group and late-stage group. The Cattaneo scoring method, the Dermatology Life Quality Index (DLQI) and the Female Sexual Function Index (FSFI) scores were used to evaluate the clinical effectiveness of the treatment on patients’ symptoms and clincal signs, quality of life as well as sexual function before and at 6-month after treatment.

RESULTS: The total effective rate of early-stage patients was significantly greater than that of late-stage patients at 6-month after PDT treatment (90.91% [40/44] vs 76.19% [16/21], p <0.05). At 6-month follow-up, the symptoms and clinical signs of patients in early-stage group were significantly improved compared with baseline, the average scores of itching, skin elasticity, whitening and lesion range were significantly lower than the scores before treatment (p <0.05). In late-stage group, The decrease in scores of itching, whitening and lesion range at the 6-months follow-up is significant(p <0.05), but skin elasticity (p=0.0625). On post-treatment follow-up examination, FSFI score was seen to have significantly improved in early-stage patients(from a median score of 17.45 to 21.1, p<0.05); DLQI also significantly improved after treatment (from a median score of 7 to 4, p<0.05). In late stage patients, The DLQI score improved significantly after treatment (from a median score of 18 to 15, p<0.05). However, the improvement in sexual function is not statistically significant (pre-treatment: median=10.55, post-treatment: median=10, p=0.1865).

CONCLUSION: Photodynamic therapy can effectively improve most symptoms and clinical signs, as well as quality of life of patients with VLS, especially for earlly stage patients. Moreover, improvement in sexual function is observed in early stage patients after PDT treatment. This study suggests that early and timely PDT treatment are recommended to achieve better results.

PMID:38825158 | DOI:10.1016/j.pdpdt.2024.104226

J Am Pharm Assoc (2003). 2024 May 31:102138. doi: 10.1016/j.japh.2024.102138. Online ahead of print.

ABSTRACT

BACKGROUND: Kratom is an herbal supplement that has drawn attention for its use in the self-treatment of opioid withdrawal, and its widespread availability with minimal restrictions. Past web-based research has attempted to determine patterns and trends of use, but generalizability to underserved populations is unclear.

OBJECTIVE: The purpose of this study was to characterize behavior related to kratom, attitudes toward kratom, and knowledge of kratom in a rural, underserved population.

METHODS: We developed, refined, and administered a cross-sectional, 36-item survey to examine use, attitudes, and knowledge of kratom. We recruited participants and administered the survey alongside medical office appointments between January and April 2023. Data were summarized using descriptive statistics.

RESULTS: A convenient sample of 186 patients (of the 907-patient clinic panel) were invited to participate and 150 returned the survey. A majority of patients were female (52.0%) and White (86.6%), and about half had an income below the federal poverty level (48.5%). Seventeen participants reported prior experience with kratom use, with one actively using kratom. The most commonly reported reasons for use were pain (47.1%) and mental health (41.2%). Kratom knowledge was low regardless of kratom use history, with the majority of respondents correctly answering between 1 and 3 questions (n = 71 of 86; 82.3%) of the 5 knowledge-focused items.

CONCLUSION: Results suggest that while active kratom use is uncommon in this Oregon population, one in ten surveyed had used kratom. Regardless of past use, respondents had limited knowledge of kratom. Future research should focus on understanding trends in kratom use behaviors in underserved populations, addressing patient knowledge gaps, and evaluating patient safety and health equity implications.

PMID:38825151 | DOI:10.1016/j.japh.2024.102138

Neurosci Lett. 2024 May 31:137849. doi: 10.1016/j.neulet.2024.137849. Online ahead of print.

ABSTRACT

INTRODUCTION: Transcranial alternating current stimulation (tACS) at 5-Hz to the right hemisphere can effectively alleviate anxiety symptoms. This study aimed to explore the neural mechanisms that drive the therapeutic benefits.

METHODS: We collected electroencephalography (EEG) data from 24 participants with anxiety disorders before and after a tACS treatment session. tACS was applied over the right hemisphere, with 1.0 mA at F4, 1.0 mA at P4, and 2.0 mA at T8 (10-10 EEG convention). With eLORETA, we transformed the scalp signals into the current source density in the cortex. We then assessed the differences between post- and pre-treatment brain maps across multiple spectra (delta to low gamma) with non-parametric statistics.

RESULTS: We observed a trend of heightened power in alpha and reduced power in mid-to-high beta and low gamma, in accord with the EEG markers of anxiolytic effects reported in previous studies. Additionally, we observed a consistent trend of de-synchronization at the stimulating sites across spectra.

CONCLUSION: tACS 5-Hz over the right hemisphere demonstrated EEG markers of anxiety reduction. The after-effects of tACS on the brain are intricate and cannot be explained solely by the widely circulated entrainment theory. Rather, our results support the involvement of plasticity mechanisms in the offline effects of tACS.

PMID:38825146 | DOI:10.1016/j.neulet.2024.137849

J Manag Care Spec Pharm. 2024 Jun;30(6):588-598. doi: 10.18553/jmcp.2024.30.6.588.

ABSTRACT

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a heterogeneous condition with extensive psychiatric comorbidities. ADHD has been associated with substantial clinical and economic burden; however, little is known about the incremental burden specifically attributable to psychiatric comorbidities of ADHD in adults.

OBJECTIVE: To assess the impact of psychiatric comorbidities, specifically anxiety and depression, on health care resource utilization (HRU) and costs in treated adults with ADHD in the United States.

METHODS: A retrospective case-cohort study was conducted. Adults with ADHD were identified in the IQVIA PharMetrics Plus database (10/01/2015-09/30/2021). The index date was defined as the date of initiation of a randomly selected ADHD treatment. The baseline period was defined as the 6 months prior to the index date, and the study period as the 12 months following the index date. Patients with at least 1 diagnosis for anxiety and/or depression during both the baseline and study periods were classified in the ADHD+anxiety/depression cohort, whereas those without diagnoses for anxiety or depression at any time were classified in the ADHD-only cohort. Entropy balancing was used to create reweighted cohorts with similar baseline characteristics. All-cause HRU and health care costs were assessed during the study period and compared between cohorts using regression analyses. Cost analyses were also conducted in subgroups stratified by comorbid conditions.

RESULTS: After reweighting, patients in the ADHD-only cohort (N = 276,906) and ADHD+anxiety/depression cohort (N = 217,944) had similar characteristics (mean age 34.1 years; 54.8% male). All-cause HRU was higher in the ADHD+anxiety/depression cohort than the ADHD-only cohort (incidence rate ratios for inpatient admissions: 4.5, emergency department visits: 1.8, outpatient visits: 2.0, and psychotherapy visits: 6.4; all P < 0.01). All-cause health care costs were more than 2 times higher in the ADHD+anxiety/depression cohort than the ADHD-only cohort (mean per-patient per-year [PPPY] costs in ADHD-only vs ADHD+anxiety/depression cohort: $5,335 vs $11,315; P < 0.01). Among the ADHD+anxiety/depression cohort, average all-cause health care costs were $9,233, $10,651, and $15,610 PPPY among subgroup of patients with ADHD and only anxiety, only depression, and both anxiety and depression, respectively.

CONCLUSIONS: Comorbid anxiety and depression is associated with additional HRU and costs burden in patients with ADHD. Comanagement of these conditions is important and has the potential to alleviate the burden experienced by patients and the health care system.

PMID:38824634 | DOI:10.18553/jmcp.2024.30.6.588

J Manag Care Spec Pharm. 2024 Jun;30(6):609-616. doi: 10.18553/jmcp.2024.30.6.609.

ABSTRACT

Medicare’s Part D Medication Therapy Management (MTM) programs serve approximately 4.5 million eligible beneficiaries. Prior research suggested that the thresholds to enter Part D MTM programs would disproportionately favor White beneficiaries compared with Black or Hispanic beneficiaries. This article summarizes those initial studies and compares the results with more recent analyses of racial and ethnic differences in MTM program enrollment, which, in general, show higher odds of MTM enrollment for minority beneficiaries compared with White beneficiaries. Disparities in the utilization of comprehensive medication review (CMR), a core MTM service, are also discussed. Although trends vary, disparities exist for various minority groups. For example, Black beneficiaries and Hispanic beneficiaries are less likely to be offered a CMR compared with White beneficiaries. Additionally, minority (Asian, Hispanic, and North American Native) beneficiaries are less likely to receive a CMR after being offered the service compared with White beneficiaries. Black, Hispanic, and Asian beneficiaries are more likely than White beneficiaries to have a longer duration between MTM enrollment and CMR offer. There is also a distinct difference in the type of pharmacist (ie, plan pharmacist, MTM vendor pharmacist, or community pharmacist) completing the CMR for certain racial and ethnic groups. For example, compared with White beneficiaries, Black beneficiaries were less likely to receive a CMR from a community pharmacist, whereas Asian beneficiaries were more likely.

PMID:38824629 | DOI:10.18553/jmcp.2024.30.6.609

J Manag Care Spec Pharm. 2024 Jun;30(6):528-540. doi: 10.18553/jmcp.2024.30.6.528.

ABSTRACT

BACKGROUND: Head-to-head trials comparing centanafadine, an investigational therapy for adults with attention-deficit/hyperactivity disorder (ADHD), with other treatment options are lacking.

OBJECTIVE: To compare safety and efficacy outcomes of centanafadine sustained-release vs lisdexamfetamine dimesylate (lisdexamfetamine), atomoxetine hydrochloride (atomoxetine), and viloxazine extended-release (viloxazine ER), respectively, using matching-adjusted indirect comparison (MAIC).

METHODS: This MAIC included patient-level data pooled from 2 centanafadine trials (NCT03605680 and NCT03605836) and published aggregate data from comparable trials of 3 comparators-lisdexamfetamine (NCT00334880), atomoxetine (NCT00190736), and viloxazine ER (NCT04016779)-in adult patients with ADHD. Propensity score weighting was used to match characteristics of individual patients from the centanafadine trials to aggregate baseline characteristics from the respective comparator trials. Safety outcomes were rates of adverse events for which information was available in the centanafadine and respective comparator trials. Efficacy outcome was mean change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) score (ADHD Rating Scale [ADHD-RS] was used as proxy in the comparison with lisdexamfetamine). Anchored indirect comparisons were conducted across matched populations of the centanafadine and respective comparator trials.

RESULTS: After matching, baseline characteristics in the centanafadine trials were the same as those in the respective comparator trials. Compared with lisdexamfetamine, centanafadine was associated with a significantly lower risk of lack of appetite (risk difference [RD] in percentage points: 23.42), dry mouth (19.27), insomnia (15.35), anxiety (5.21), nausea (4.90), feeling jittery (3.70), and diarrhea (3.47) (all P < 0.05) but a smaller reduction in the AISRS/ADHD-RS score (6.58-point difference; P < 0.05). Compared with atomoxetine, centanafadine was associated with a significantly lower risk of nausea (RD in percentage points: 18.64), dry mouth (17.44), fatigue (9.21), erectile dysfunction (6.76), lack of appetite (6.71), and urinary hesitation (5.84) (all P < 0.05) and no statistically significant difference in the change in AISRS score. Compared with viloxazine ER, centanafadine was associated with a significantly lower risk of fatigue (RD in percentage points: 11.07), insomnia (10.67), nausea (7.57), and constipation (4.63) (all P < 0.05) and no statistically significant difference in the change in AISRS score.

CONCLUSIONS: In an anchored MAIC, centanafadine showed a significantly better short-term safety profile than lisdexamfetamine, atomoxetine, and viloxazine ER; efficacy was lower than with lisdexamfetamine and comparable (ie, nondifferent) with atomoxetine and viloxazine ER. This MAIC provides important insights on the relative safety and efficacy of common treatment options to help inform treatment decisions in adults with ADHD. Safety assessment was limited to rates of adverse events reported in both trials of a given comparison.

STUDY REGISTRATION NUMBERS: NCT03605680, NCT03605836, NCT00334880, NCT00190736, and NCT04016779.

PMID:38824626 | DOI:10.18553/jmcp.2024.30.6.528

J Manag Care Spec Pharm. 2024 Jun;30(6):549-559. doi: 10.18553/jmcp.2024.30.6.549.

ABSTRACT

BACKGROUND: Schizophrenia and schizoaffective disorder require long-term antipsychotic treatment with antipsychotic medications, but poor medication adherence can lead to increased health care utilization and costs. Long-acting injectable antipsychotics (LAIs) offer potential therapeutic advantages in that they require less frequent dosing and improved medication adherence. South Carolina has the highest adoption of LAIs among US states, making it an ideal population for comparing the effectiveness of LAIs vs oral antipsychotics (OAPs) in treating schizophrenia or schizoaffective disorder.

OBJECTIVE: To evaluate the effect of LAIs compared with OAPs on medication adherence, health care resource utilization, and costs among South Carolina Medicaid beneficiaries with schizophrenia or schizoaffective disorder.

METHODS: South Carolina Medicaid beneficiaries with at least 1 claim for an LAI or OAP between January 1, 2015, and December 31, 2018, aged 18 to 65, with at least 2 claims with diagnoses of schizophrenia or schizoaffective disorder were included. Propensity scores (PSs) were calculated using logistic regression adjusting for confounders and predictors of the outcome. We estimated the “average treatment effect on the treated” by employing PS-weighted t-tests and chi-square tests.

RESULTS: A total of 3,531 patients met the inclusion criteria, with 1,537 (44.5%) treated with LAIs and 1,994 (56.5%) treated with OAPs. In PS-weighted analyses, the LAI cohort had a greater proportion of days covered than the OAP cohort with a 365-day fixed denominator (69% vs 64%; P < 0.0001), higher medication possession ratio with a variable denominator while on therapy (85% vs 80%; P < 0.0001), and higher persistence (82% vs 64%; P < 0.0001). The average number of inpatient visits and emergency department visits did not significantly differ between cohorts (0.28 hospitalizations, P = 0.90; 3.68 vs 2.96 emergency department visits, P = 0.19). The number of outpatient visits, including visits for medication administration, were greater in the LAI cohort (23.1 [SD 24.2]) vs OAP (16.9 [SD 21.2]; P < 0.0001); however, including the costs for medication administration visits, outpatient costs (per member) were approximately $2,500 lower in the LAI cohort (P < 0.0001). The number of pharmacy visits was greater in the OAP cohort (LAI 21.0 [SD 17.0] vs OAP 23.0 [SD 15.0]; P = 0.006). All-cause total costs were greater in the LAI cohort ($26,025 [SD $29,909]) vs the OAP cohort ($17,291 [SD $25,261]; P < 0.0001) and were driven by the difference in pharmaceutical costs (LAI $15,273 [SD $16,183] vs OAP $4,696 [SD $10,371]; P < 0.0001).

CONCLUSIONS: Among South Carolina Medicaid beneficiaries, treatment with LAIs for schizophrenia or schizoaffective disorder was associated with greater medication adherence rates. Patients using LAIs had higher drug costs and total costs, but lower outpatient and total nondrug costs compared with those using OAPs.

PMID:38824623 | DOI:10.18553/jmcp.2024.30.6.549