Nevin Manimala

Medicine (Baltimore). 2024 Aug 9;103(32):e39055. doi: 10.1097/MD.0000000000039055.

ABSTRACT

Polycystic ovary syndrome (PCOS) is a disease caused by excessive ovarian androgen secretion due to hypothalamic-pituitary-ovarian hormone abnormalities. We retrospectively investigated the treatment status of patients diagnosed with PCOS who visited a domestic tertiary hospital in order to analyze the use patterns and safety of drugs. Patients diagnosed with PCOS between July 2014 and September 2022 were examined, excluding patients younger than 13 years and those not receiving medication. Patients aged 21 years or younger were designated as the adolescent group and patients aged 22 years or older were designated as the adult group for comparative statistical analysis. The total number of patients was 212, including 105 adolescents (49.5%) and 107 adults (50.5%). Comorbidities were ovarian cyst in 20 (9.4%) patients, endometriosis in 19 (9%), diabetes in 14 (6.6%), thyroid dysfunction in 12 (5.7%), hypertension in 10 (4.7%), dyslipidemia in 10 (4.7%), and androgenic alopecia in 6 (2.8%). Symptoms were oligomenorrhea in 91 (42.9%) patients, amenorrhea in 72 (34%), hirsutism in 36 (17%), acne in 24 (11.3%), and infertility in 10 (4.7%). During the study period, 114 patients (53.8%) were prescribed medroxyprogesterone acetate (MPA), 66 (31.1%) were given oral contraceptives (specifically, ethinyl estradiol + drospirenone prescribed to 52 (24.5%)), and 17 (8%) were concurrently prescribed MPA and oral contraceptives. Forty-five (21.2%) patients changed prescriptions, with 10 (22.2%) switching due to side effects and 8 (17.8%) due to a therapeutic failure. A total of 5 patients (2.4%) discontinued the drug. Adverse drug reactions occurred in 15 patients (7.1%), with 5 being adolescents (4.8%) and 10 being adults (9.3%). MPA alone and ethinyl estradiol with drospirenone were the most prescribed medications for PCOS. Over the study, 45 patients changed prescriptions, 50 were lost to follow-up, and 5 adults discontinued medications.

PMID:39121320 | DOI:10.1097/MD.0000000000039055

Alzheimers Dement. 2023 Dec;19 Suppl 24:e082773. doi: 10.1002/alz.082773.

ABSTRACT

BACKGROUND: This study aims to detect direct cost savings with early detection of Alzheimer’s disease (AD) and related dementias. We hypothesize that earlier diagnosis of AD can reduce direct healthcare costs and unnecessary utilization. A retrospective case-control study is conducted using Optum Market Clarity Claims/EHR linked dataset on Medicare Advantage population from Jan 1 2011 to Dec 31 2020.

METHOD: Based on whether the patient was diagnosed with prior Mild Cognitive Impairment (MCI) before progressing to an AD diagnosis per ICD-9/10 cm diagnosis codes, AD patients are categorized into early vs. late diagnosis (for those who were identified in the MCI stage vs not). Both groups are compared on annual all-cause healthcare costs and frequency of encounters longitudinally spanning across 6 years pre-index period and 3 years post-index with AD diagnosis date as the index date. To understand the impact of early diagnosis, we estimated total cost, medical service cost and drug cost post-index within the first 3 years by risk adjustment on baseline demographics, comorbidities, procedures, lab tests, and visits prior to AD diagnosis using propensity score weighting.

RESULT: Early-diagnosed patients (N = 421) have a lower utilization rate of inpatient skilled nursing facility, nursing home and hospitalization than late-diagnosed patients (N = 2817) after being diagnosed with AD. We also observed average medical service cost savings in all 3 years post-index, ranging from $320 to $2556 per patient per year. Per cost allocation analysis, medical service cost savings are observed in inpatient, emergency room, inpatient SNF, urgent care, nursing home/assisted living, and observation unit. Risk adjusted cost savings with statistical significance are observed in year 3 post-index. The mean cost difference between late and early diagnoses: total cost ($15472.11), medical service ($15013.7) and medication cost ($1601.61).

CONCLUSION: The study highlights opportunities for earlier diagnosis and suggests long-term healthcare savings for AD patients who have been diagnosed at MCI stage compared to patients who were directly diagnosed with AD. Further research is needed to drill down into the driver of cost savings and whether it is attributable to disease management of MCI or other complications.

PMID:39120933 | DOI:10.1002/alz.082773

Microb Genom. 2024 Aug;10(8). doi: 10.1099/mgen.0.001281.

ABSTRACT

Haemophilus influenzae is part of the human nasopharyngeal microbiota and a pathogen causing invasive disease. The extensive genetic diversity observed in H. influenzae necessitates discriminatory analytical approaches to evaluate its population structure. This study developed a core genome multilocus sequence typing (cgMLST) scheme for H. influenzae using pangenome analysis tools and validated the cgMLST scheme using datasets consisting of complete reference genomes (N = 14) and high-quality draft H. influenzae genomes (N = 2297). The draft genome dataset was divided into a development dataset (N = 921) and a validation dataset (N = 1376). The development dataset was used to identify potential core genes, and the validation dataset was used to refine the final core gene list to ensure the reliability of the proposed cgMLST scheme. Functional classifications were made for all the resulting core genes. Phylogenetic analyses were performed using both allelic profiles and nucleotide sequence alignments of the core genome to test congruence, as assessed by Spearman’s correlation and ordinary least square linear regression tests. Preliminary analyses using the development dataset identified 1067 core genes, which were refined to 1037 with the validation dataset. More than 70% of core genes were predicted to encode proteins essential for metabolism or genetic information processing. Phylogenetic and statistical analyses indicated that the core genome allelic profile accurately represented phylogenetic relatedness among the isolates (R ² = 0.945). We used this cgMLST scheme to define a high-resolution population structure for H. influenzae, which enhances the genomic analysis of this clinically relevant human pathogen.

PMID:39120932 | DOI:10.1099/mgen.0.001281

J Med Internet Res. 2024 Aug 9;26:e55151. doi: 10.2196/55151.

ABSTRACT

BACKGROUND: Searching for web-based health-related information is frequently performed by the public and may affect public behavior regarding health decision-making. Particularly, it may result in anxiety, erroneous, and harmful self-diagnosis. Most searched health-related topics are cancer, cardiovascular diseases, and infectious diseases. A health-related web-based search may result in either formal or informal medical website, both of which may evoke feelings of fear and negativity.

OBJECTIVE: Our study aimed to assess whether there is a difference in fear and negativity levels between information appearing on formal and informal health-related websites.

METHODS: A web search was performed to retrieve the contents of websites containing symptoms of selected diseases, using selected common symptoms. Retrieved websites were classified into formal and informal websites. Fear and negativity of each content were evaluated using 3 transformer models. A fourth transformer model was fine-tuned using an existing emotion data set obtained from a web-based health community. For formal and informal websites, fear and negativity levels were aggregated. t tests were conducted to evaluate the differences in fear and negativity levels between formal and informal websites.

RESULTS: In this study, unique websites (N=1448) were collected, of which 534 were considered formal and 914 were considered informal. There were 1820 result pages from formal websites and 1494 result pages from informal websites. According to our findings, fear levels were statistically higher (t₂₇₅₃=3.331; P<.001) on formal websites (mean 0.388, SD 0.177) than on informal websites (mean 0.366, SD 0.168). The results also show that the level of negativity was statistically higher (t₂₇₅₃=2.726; P=.006) on formal websites (mean 0.657, SD 0.211) than on informal websites (mean 0.636, SD 0.201).

CONCLUSIONS: Positive texts may increase the credibility of formal health websites and increase their usage by the general public and the public’s compliance to the recommendations. Increasing the usage of natural language processing tools before publishing health-related information to achieve a more positive and less stressful text to be disseminated to the public is recommended.

PMID:39120928 | DOI:10.2196/55151

JAMA Netw Open. 2024 Aug 1;7(8):e2427053. doi: 10.1001/jamanetworkopen.2024.27053.

NO ABSTRACT

PMID:39120906 | DOI:10.1001/jamanetworkopen.2024.27053

JAMA Netw Open. 2024 Aug 1;7(8):e2427382. doi: 10.1001/jamanetworkopen.2024.27382.

NO ABSTRACT

PMID:39120905 | DOI:10.1001/jamanetworkopen.2024.27382

JAMA Netw Open. 2024 Aug 1;7(8):e2424082. doi: 10.1001/jamanetworkopen.2024.24082.

ABSTRACT

IMPORTANCE: The White House National Strategy on Hunger, Nutrition, and Health included expanding free school meals to all students, regardless of income, which has sparked debate in the United States.

OBJECTIVE: To assess the association between universal free school meals (UFSMs) and school and student outcomes in the United States.

EVIDENCE REVIEW: An expert panel-informed protocol was developed to evaluate intervention or cohort studies comparing UFSM programs, such as the Community Eligibility Provision (CEP), with non-UFSM programs in US schools from August 2012 (excluding 2020-2021 due to the COVID-19 pandemic) in peer-reviewed publications or government reports. Outcomes included meal participation rates, attendance, dietary intake and quality, food waste, economic impact, food insecurity, anthropometrics, disciplinary actions, stigma, and shaming. A search of Medline, Econlit, Business Source Ultimate, ERIC, Agricola, Cab Abstracts, and CINAHL was performed in April 2024. Two researchers screened articles for inclusion, extracted data, and assessed risk of bias, using the Risk of Bias in Nonrandomized Studies of Interventions tool, for each included study. Grading of Recommendations, Assessment, Development, and Evaluations was used to assess the certainty of evidence for each outcome.

FINDINGS: The search identified 2784 records, with 6 studies included, representing more than 11 000 elementary, middle, and high schools. Nonrandomized intervention studies performed difference-in-difference or rate ratio analysis to investigate CEP participation rates, attendance, anthropometrics, and/or suspensions. CEP was associated with increased lunch (3 studies; moderate certainty) and breakfast (1 study; very low certainty) participation. School attendance was unchanged or improved in schools with CEP compared with schools without UFSM (2 studies; low certainty). CEP was associated with lower obesity prevalence (1 study; very low certainty) and fewer suspensions (1 study; very low certainty). Reasons for downgrading the certainty ratings included indirectness (data not fully representative of the United States) and inconsistency (small number of studies limiting ability to assess consistency). Despite the limitations, the evidence reflected well-designed longitudinal intervention studies appropriate for decision-making.

CONCLUSIONS AND RELEVANCE: In this systematic review, UFSMs were associated with increased meal participation, no or slight improvements in attendance, and decreased obesity prevalence and suspension rates; certainty of evidence was moderate for lunch participation and low or very low for other outcomes. Studies did not report several important outcomes, such as diet quality and food security, suggesting the need for more high-quality research encompassing policy-relevant indicators.

PMID:39120904 | DOI:10.1001/jamanetworkopen.2024.24082

JAMA Netw Open. 2024 Aug 1;7(8):e2425856. doi: 10.1001/jamanetworkopen.2024.25856.

ABSTRACT

IMPORTANCE: Insomnia is highly prevalent in patients with nonspecific chronic spinal pain (nCSP). Given the close interaction between insomnia and pain, targeting sleep problems during therapy could improve treatment outcomes.

OBJECTIVE: To evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBTi) integrated in best-evidence pain management (BEPM) vs BEPM only in patients with nCSP and insomnia.

DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized clinical trial with 1-year follow-up was conducted between April 10, 2018, and April 30, 2022. Data and statistical analysis were performed between May 1, 2022, and April 24, 2023. Patients with nCSP and insomnia were evaluated using self-report and at-home polysomnography, to exclude underlying sleep pathologic factors. Participants were treated at the University Hospital Brussels or University Hospital Ghent, Belgium. Intention-to-treat analysis was performed.

INTERVENTIONS: Participants were randomized to either CBTi-BEPM or BEPM only. Both groups received 18 treatment sessions over 14 weeks. The CBTi-BEPM treatment included 6 CBTi sessions and 12 BEPM sessions. The BEPM treatment included pain neuroscience education (3 sessions) and exercise therapy (9 sessions in the CBTi-BEPM group, 15 sessions in the BEPM-only group).

MAIN OUTCOMES AND MEASURES: The primary outcome was change in mean pain intensity (assessed with Brief Pain Inventory [BPI]) at 12 months after the intervention. Exploratory secondary outcomes included several pain- and sleep-related outcomes. Blinded outcome assessment took place at baseline, posttreatment, and at 3-, 6-, and 12-month follow-up.

RESULTS: A total of 123 patients (mean [SD] age, 40.2 [11.18] years; 84 women [68.3%]) were included in the trial. In 99 participants (80.5%) with 12-month BPI data, the mean pain intensity at 12 months decreased by 1.976 points (reduction of 40%) in the CBTi-BEPM group and 1.006 points (reduction of 24%) points in the BEPM-only group. At 12 months, there was no significant difference in pain intensity change between groups (mean group difference, 0.970 points; 95% CI, -0.051 to 1.992; Cohen d, 2.665). Treatment with CBTi-BEPM resulted in a response for BPI average pain with a number needed to treat (NNT) of 4 observed during 12 months. On a preliminary basis, CBTi-BEPM was, consistently over time and analyses, more effective than BEPM only for improving insomnia severity (Cohen d, 4.319-8.961; NNT for response ranging from 2 to 4, and NNT for remission ranging from 5 to 12), sleep quality (Cohen d, 3.654-6.066), beliefs about sleep (Cohen d, 5.324-6.657), depressive symptoms (Cohen d, 2.935-3.361), and physical fatigue (Cohen d, 2.818-3.770). No serious adverse effects were reported.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, adding CBTi to BEPM did not further improve pain intensity reduction for patients with nCSP and comorbid insomnia more than BEPM alone. Yet, as CBTi-BEPM led to significant and clinically important changes in insomnia severity and sleep quality, CBTi integrated in BEPM should be considered in the treatment of patients with nCSP and comorbid insomnia. Further research can investigate the patient characteristics that moderate the response to CBTi-BEPM in terms of pain-related outcomes, as understanding of these moderators may be of utmost clinical importance.

TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT03482856.

PMID:39120902 | DOI:10.1001/jamanetworkopen.2024.25856

JAMA Netw Open. 2024 Aug 1;7(8):e2426702. doi: 10.1001/jamanetworkopen.2024.26702.

ABSTRACT

IMPORTANCE: Concerns have been raised about the abuse liability of modern e-cigarettes that use acidic additives to form nicotine salts, making the inhalation of nicotine smoother than freebase nicotine.

OBJECTIVE: To examine the effects of nicotine form and concentration and e-liquid flavor on subjective effects ratings, vaping behavior, and nicotine uptake among young adults who use e-cigarettes.

DESIGN, SETTING, AND PARTICIPANTS: In this single-blind, within-participant, crossover randomized clinical trial, a convenience sample of young adults aged 21 to 25 years who currently used e-cigarettes was recruited from December 2021 to August 2023, for in-person research laboratory visits in Columbus, Ohio.

INTERVENTIONS: Participants completed up to 9 vaping sessions, starting with their usual e-cigarette brand in the first session followed by 1 of 8 laboratory-prepared e-liquids in a randomly assigned order in each subsequent session. Prepared e-liquids varied by nicotine form (salt-based vs freebase), nicotine concentration (5% vs 1% weight per weight), and flavor (menthol vs tobacco). Each session included a 5-minute, 10-puff standardized vaping period followed by 30 minutes of ad libitum vaping.

MAIN OUTCOMES AND MEASURES: At 4 time points (0, 5, 10, and 35 minutes) during each vaping session, plasma samples were collected for assessing nicotine uptake, and self-reports of urges, craving, and withdrawal were collected via questionnaires. Positive subjective effects were self-reported after 35 minutes of vaping using a visual analog scale; urges and cravings were reported using the Questionnaire of Smoking Urges (QSU). Puff topography data were collected throughout each vaping session.

RESULTS: Seventy-two participants (mean [SD] age, 22.4 [1.4] years; 42 [58.3%] female) who sampled at least 1 laboratory-prepared e-liquid composed the analytic sample. Salt-based (vs freebase) nicotine e-liquids increased nicotine intake, with 5% salt-based e-liquids delivering the highest mean plasma levels of nicotine (11.2 ng/mL [95% CI, 9.3-13.2 ng/mL] at 5 minutes; 17.2 ng/mL [95% CI, 14.3-20.1 ng/mL] at 35 minutes) irrespective of flavors. Higher positive subjective effect ratings (eg, for liking) were received by salt-based (42.8; 95% CI, 39.4-46.1) vs freebase (32.0; 95% CI, 28.6-35.3) nicotine, 1% (43.4; 95% CI, 40.2-46.6) vs 5% (31.2; 95% CI, 27.7-34.6) nicotine, and menthol-flavored (43.2; 95% CI, 39.7-46.7) vs tobacco-flavored (31.5; 95% CI, 28.4-34.7) e-liquids. Salt-based and 1% but not menthol-flavored nicotine elicited more intense puffing (eg, 25% [95% CI, 12%-40%] more total puffs for nicotine salts vs freebase). All study e-liquids reduced urges and cravings, with 5% vs 1% nicotine being more effective (mean [SE] QSU-Desire score at 35 minutes, 15.4 [0.5] vs 16.7 [0.5]).

CONCLUSIONS AND RELEVANCE: In this crossover randomized clinical trial among young adult e-cigarette users, salt-based (vs freebase) nicotine e-liquids increased nicotine intake and yielded more positive subjective effects ratings and intense puffing behaviors, suggesting higher abuse potential. Restricting the level of acidic additives and menthol flavoring may reduce the addictiveness of e-cigarettes.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05458895.

PMID:39120901 | DOI:10.1001/jamanetworkopen.2024.26702

JAMA Netw Open. 2024 Aug 1;7(8):e2426802. doi: 10.1001/jamanetworkopen.2024.26802.

ABSTRACT

IMPORTANCE: Insurance coverage affects health care access for many delivering women diagnosed with perinatal mood and anxiety disorders (PMADs). The Mental Health Parity and Addiction Equity Act (MHPAEA; passed in 2008) and the Patient Protection and Affordable Care Act (ACA; passed in 2010) aimed to improve health care access.

OBJECTIVE: To assess associations between MHPAEA and ACA implementation and psychotherapy use and costs among delivering women overall and with PMADs.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study conducted interrupted time series analyses of private insurance data from January 1, 2007, to December 31, 2019, for delivering women aged 15 to 44 years, including those with PMADs, to assess changes in psychotherapy visits in the year before and the year after delivery. It estimated changes in any psychotherapy use and per-visit out-of-pocket costs (OOPCs) for psychotherapy associated with MHPAEA (January 2010) and ACA (January 2014) implementation. Data analyses were performed from August 2022 to May 2023.

EXPOSURES: Implementation of the MHPAEA and ACA.

MAIN OUTCOMES AND MEASURES: Any psychotherapy use and per-visit OOPCs for psychotherapy standardized to 2019 dollars.

RESULTS: The study included 837 316 overall deliveries among 716 052 women (mean [SD] age, 31.2 [5.4] years; 7.6% Asian, 8.8% Black, 12.8% Hispanic, 64.1% White, and 6.7% unknown race and ethnicity). In the overall cohort, a nonsignificant step change was found in the delivering women who received psychotherapy after MHPAEA implementation of 0.09% (95% CI, -0.04% to 0.21%; P = .16) and a nonsignificant slope change of delivering women who received psychotherapy of 0.00% per month (95% CI, -0.02% to 0.01%; P = .69). A nonsignificant step change was found in delivering individuals who received psychotherapy after ACA implementation of 0.11% (95% CI, -0.01% to 0.22%; P = .07) and a significantly increased slope change of delivering individuals who received psychotherapy of 0.03% per month (95% CI, 0.00% to 0.05%; P = .02). Among those with PMADs, the MHPAEA was associated with an immediate increase (0.72%; 95% CI, 0.26% to 1.18%; P = .002) then sustained decrease (-0.05%; -0.09% to -0.02%; P = .001) in psychotherapy receipt; the ACA was associated with immediate (0.77%; 95% CI, 0.26% to 1.27%; P = .003) and sustained (0.07%; 95% CI, 0.02% to 0.12%; P = .005) monthly increases. In both populations, per-visit monthly psychotherapy OOPCs decreased (-$0.15; 95% CI, -$0.24 to -$0.07; P < .001 for overall and -$0.22; -$0.32 to -$0.12; P < .001 for the PMAD population) after MHPAEA passage with an immediate increase ($3.14 [95% CI, $1.56-$4.73]; P < .001 and $2.54 [95% CI, $0.54-$4.54]; P = .01) and steady monthly increase ($0.07 [95% CI, $0.02-$0.12]; P = .006 and $0.10 [95% CI, $0.03-$0.17]; P = .004) after ACA passage.

CONCLUSIONS AND RELEVANCE: This study found complementary and complex associations between passage of the MHPAEA and ACA and access to psychotherapy among delivering individuals. These findings indicate the value of continuing efforts to improve access to mental health treatment for this population.

PMID:39120900 | DOI:10.1001/jamanetworkopen.2024.26802