6-month Visit Research Articles

Study protocol for Sauti ya Vijana (The Voice of Youth): A hybrid-type 1 randomized trial to evaluate effectiveness and implementation of a mental health and life skills intervention to improve health outcomes for Tanzanian youth living with HIV.

Young people living with HIV (YPLWH) experience increased morbidity and mortality compared to all other age groups. Adolescence brings unique challenges related to sexual reproductive health, the elevated importance of peer groups, and often, emerging symptoms of emotional distress. Failure to address this unique life stage for YPLWH can lead to worse HIV and mental health outcomes. Herein lies the protocol for a hybrid-type-1 effectiveness-implementation trial designed to evaluate a mental health and life skills intervention that aims to address these needs for YPLWH in Tanzania. This is an individually randomized group-treatment trial designed to evaluate the effectiveness of Sauti ya Vijana (SYV: The Voice of Youth) toward improving viral suppression (HIV RNA <400 copies/mL) and mental health outcomes and to assess implementation including acceptability, feasibility, fidelity, and cost-effectiveness of the manualized intervention. The trial is being conducted across four geographically distinct regions of Tanzania. Peer group leaders (PGL) with lived HIV experience deliver the 10-session group-based intervention and two individual sessions during which participants describe their disclosure narrative (when they learned they live with HIV) and value-based goal setting. Caregiver or chosen supportive adults are encouraged to attend two specific group sessions with their youth. Participants are 10-24 years of age, prescribed antiretroviral therapy for at least 6 months, fully aware of their HIV status, able to commit to session attendance, and able to understand and meaningfully contribute to group sessions. Participant study visits occur at 5 time points for evaluation: baseline, 4-, 6-, 12-, and 18-months post baseline. A single booster session is conducted before the 12-month visit. Study visits evaluate mental health, adverse childhood events, interpersonal violence, resilience, stigma, HIV knowledge, substance use, sexual relationships, ART adherence, and HIV RNA. Implementation outcomes evaluate feasibility and acceptability through attendance, intervention session notes, focus discussion groups and qualitative interviews. Fidelity to the intervention is measured using fidelity checklists by a PGL observer at each group session. Cost effectiveness is calculated using an incremental cost-effectiveness ratio that utilizes a patient cost questionnaire and financial records of study costs. Few mental health interventions for YPLWH have demonstrated effectiveness. Results from this study will provide information about effectiveness and implementation of a peer-led intervention for delivering a mental health and life skills intervention in low-income settings. This trial is registered at clinicaltrials.gov NCT05374109.

EMPOWERING B40 WOMEN IN MALAYSIA: A SOCIOECONOMIC IMPACT ASSESSMENT OF THE ECER-SURI@HOME PROGRAM

Women can be categorised as one of the marginalised and disadvantaged groups in Malaysia. With the COVID-19 pandemic that has hit Malaysia over the past three years, the vulnerability of Malaysian women in aspects of mental health and limited or inflexible occupations has increased. ECER-Suri@Home is a socioeconomic development program designed for women in ECER, especially housewives and single mothers with mobility constraints, to engage in home-based businesses, such as tenun and songket weaving, as a means to help them earn regular additional income. This study aims to assess the socioeconomic impact of the ECER-Suri@Home program on the participants and explore how the monitoring practice used can influence the sustainability of the program in empowering the wellbeing of B40 women in Terengganu. This study employed quantitative and qualitative approaches in data collection by distributing questionnaires to the program’s participants and in-depth interviews with several key informants from ECERDC and Yayasan Pembangunan Keluarga Terengganu. The outcome of this study revealed that this program has had a high impact on the economic status of the participants. The monthly monitoring visit has increased the productivity and quality of the tenun songket produced by the participants; however, this program would not be sustainable for the next cohort due to the difficulty in finding suitable participants.

Returning to work and health status at 12 months among patients with COVID-19 cared for in intensive care—A prospective, longitudinal study

ObjectiveIntensive care unit (ICU) stay for a serious illness has a long-term impact on patients’ physical and psychological well-being, affecting their ability to return to their everyday life. We aimed to investigate whether there are differences in health status between those who return to work and those who do not, and how demographic characteristics and illness severity impact patients’ ability to return to work 12 months after intensive care for COVID-19. Research methodologyThis was a prospective longitudinal cohort study. The participants were patients who had been in intensive care for COVID-19 and had worked before contracting COVID-19. Data on return to previous occupational status, demographic data, comorbidities, intensive care characteristics, and health status were collected at a 12-month follow-up visit. SettingGeneral ICU at the Uppsala University Hospital in Sweden. ResultsSeventy-three participants were included in the study. Twelve months after discharge from the ICU, 77 % (n = 56) had returned to work. The participants who were unable to return to work reported more severe health symptoms. The (odds ratio [OR] for not returning to work was high for critical illness OR, 12.05; 95 % confidence interval [CI], 2.07–70.29, p = 0.006) and length of ICU stay (OR, 1.06; 95 % CI, 1.01–1.11, p = 0.01) ConclusionTwo-thirds of the participants were able to return to work within 1 year after discharge from the ICU. The primary factors contributing to the failure to work were duration of the acute disease and presence of severe and persistent long-term symptoms. Implications for clinical practicePatients’ health status must be comprehensively assessed and their ability to return to work should be addressed in the rehabilitation process. Therefore, any complications faced by the patients must be identified and treated early to increase the possibility of their successful return to work.

Advancing spatial repellents for malaria control: effectiveness and cost-effectiveness of a spatial repellent under operational use in Northern Uganda—study protocol for a cluster randomized controlled trial

BackgroundSpatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria (1) and Aedes-borne viruses (2) but their effectiveness in reducing mosquito-borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito-borne diseases in contexts where typical vector control strategies, such as insecticide-treated nets (ITNs) and indoor residual spraying, are inaccessible or underutilized such as among displaced persons or in emergency relief settings.MethodsChildren will be enrolled in 3 separate cohorts to establish the effectiveness of SRs in reducing malaria infection in different distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and the Village Health Team channel. Cohorts will be followed twice a month (approximately every 15 days): during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using a SR in an area with high, year-round transmission of malaria.DiscussionThis study will address the knowledge gap of whether or not SRs are effective in reducing human malaria disease in humanitarian assistance and emergency response settings in sub-Saharan Africa where underlying transmission rates are historically high and ITNs may or may not be widely deployed. This research will inform policy makers on whether to recommend SRs as a means to further reduce malaria transmission for such operational programs.Trial registrationClinicalTrials.gov NCT06122142. Registered on November 8, 2023.

Donor-site safety in microvascular lymph node transfer for breast cancer-related lymphedema using reverse lymphatic mapping—A prospective study

BackgroundVascularized lymph node transfer (VLNT) is one option among other surgical treatments in the management of breast cancer-related lymphedema (BCRL). The cause of concern regarding VLNT harvested from the groin has been the potential development of secondary lower-extremity lymphedema. This study explored the risk of donor-site morbidity following groin VLNT, with or without concomitant breast reconstruction. MethodThe cohort comprised data from the Lymfactin® Phase I and II trials during 2016–2019, using perioperative reverse lymphatic mapping. The volume of the lower extremities was measured preoperative and at 3, 6, and 12 months postoperative, and adverse events were documented during study visits. ResultsAltogether, 51 women with a mean age of 55.5 years were recruited. The mean duration of BCRL was 31.8 months. Of these, 25 (49%) underwent VLNT (VLNT-group) and 26 (51%) underwent VLNT in combination with breast reconstruction (VLNT-BR group). The groups were similar in terms of age (p=0.766), BMI (p=0.316), and duration of BCRL (p=0.994). Across one year, the volume difference between the lower extremities changed by 22.6ml (ranging from -813 to 860.2ml) (p=0.067). None of the patients had a lower-extremity volume difference exceeding 10% at the 12-month follow-up visit. The most frequent adverse events were postoperative pain (17.7%), wound healing issues (11.8%), and seroma formation (11.8%). Most adverse events (64.6%) were classified as minor. ConclusionsThis prospective study demonstrated that groin VLNT with reverse lymphatic mapping appears safe and does not increase the risk of secondary donor-site lymphedema within one year postoperatively.

Outcomes of Active Middle Ear Implants: Speech Perception and Quality of Life.

To evaluate audiological outcomes, quality of life, and complications in patients implanted with Active middle ear implants (AMEI). The secondary objective is to investigate the required duration after implantation to reach satisfactory outcomes. This retrospective study included 31 patients implanted with Active middle ear implants (AMEI) with different methods of floating mass transducer attachment. Patients with incomplete medical records and those who did not respond to postoperative follow-up were excluded. Patients were assessed preoperatively, and at one, three, and six months postoperatively. The assessment included Pure Tone Average (PTA4), speech reception threshold (SRT), and speech discrimination score (SDS). The Speech Spatial and Qualities of Hearing scale (SSQ12) was also used to evaluate levels of satisfaction. There are no significant differences found in PTA and SRT between the 3-, 6-, and 12-month visits. The speech reception threshold (SRT) showed a statistically significant improvement at 3, 6, and 12 months post-operative measures compared to pre-operative. Additionally, the SDS exhibited a significant increase only after 12 months, compared to the 3-month time point. However, satisfaction levels did not significantly differ between the 6-month and 12-month measurements following surgery. The Vibrant Soundbridge improves subjective satisfaction scores and audiological test scores in patients with different types of hearing loss. AMEI has a low risk of medical or surgical complications, the ease of using a hearing implant, and the social benefits of good hearing and communication.

Autism screening and diagnostic outcomes among toddlers bornpreterm.

To examine the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F), with follow-up screening and diagnostic outcomes for children born preterm. A secondary aim was to examine diagnostic evaluation attendance after screening to inform clinical practice. Using a cross-sectional design, 9725 toddlers (4951 males; 4774 females) whose gestational age was reported were screened at 15-month, 18-month, or 24-month well-child visits; screen-positive children were invited for an autism evaluation. Screening measure performance and diagnostic outcomes were evaluated according to preterm classification (Screening: nExtPreterm = 111; nVeryPreterm = 186; nModPreterm = 1122; nFullTerm = 8306; Evaluation: nExtPreterm = 27; nVeryPreterm = 21; nModPreterm = 86; nFullTerm = 301). Screen-positive rates were highest for children born extremely preterm (51.35%) and lowest for children born at term (6.95%). Evaluation attendance for screen-positive cases did not differ according to preterm classification. Rates of autism diagnoses differed depending on preterm birth status: for children born extremely preterm, it was 16.05%; for children born very preterm, it was 2.00%; for children born moderately preterm, it was 2.89%; and for children born at term, it was 1.49%. M-CHAT-R/F sensitivity decreased with increasing gestational age, whereas specificity improved with increasing gestational age. Positive predictive value was highest for children born extremely preterm and children born at term. Negative predictive value was consistently strong across all groups. The likelihood ratio for positive screening increased with gestational age. The sensitivity and specificity of the M-CHAT-R/F are acceptable in toddlers born preterm. Autism screening-positive rates and prevalence increased with earlier preterm birth. Those born extremely preterm showed the greatest likelihood of an autism diagnosis; screening should not be delayed based on adjusted age.

Comparison of the Effectiveness of Single Anastomosis Sleeve Ileal Bypass and Roux-en-Y Gastric Bypass in Obese Patients with Type 2 Diabetes.

The rapid increase in obesity and related problems has heightened the importance of obesity and metabolic surgery, resulting in a continuing search for the ideal surgical method. This study aimed to compare the effectiveness of Roux-en-Y gastric bypass (RYGB), which is the gold standard method, and the relatively newer method of single anastomosis sleeve ileal (SASI) bypass. The medical records of patients who underwent RYGB and SASI bypass were reviewed and compared regarding excess weight loss (EWL) and HgA1c, fasting glucose, serum iron, ferritin, hemoglobin (Hgb), and vitamin B12 levels. The body mass index was significantly lower (p = 0.003), and the %EWL was significantly higher (p = 0.023) at 6months postoperative in patients who underwent SASI bypass. Both groups had similar results at the other follow-up visits. The mean HgA1c levels at the 6- and 12-month follow-up visits were significantly lower in SASI patients (p = 0.037 and p = 0.012, respectively). At the 24-month follow-up, no difference was detected in HgA1c levels between the groups (p = 0.476). In patients who underwent RYGB, ferritin (p < 0.001), plasma iron (p = 0.001), and Hgb levels (p = 0.001) were significantly lower at 12, 24, and 12months postoperatively, respectively. SASI bypass is effective and comparable to RYGB in terms of EWL and metabolic control and has the advantage of not producing excluded segments and reducing nutritional deficiencies.

Comparison of One-Year Outcome of Intravitreal Aflibercept with or without Photodynamic Therapy for Polypoidal Choroidal Vasculopathy.

Background and Objectives: Our study compared the visual and anatomical outcomes of polypoidal choroidal vasculopathy (PCV) patients receiving intravitreal aflibercept (IVA) with or without photodynamic therapy (PDT) over 12 months. Materials and Methods: This retrospective study was performed for 60 eyes from 60 patients with treatment-naïve PCV. Thirty eyes were treated using IVA monotherapy (IVA group), and thirty eyes were treated using a combination of IVA with PDT (IVA/PDT group). The baseline characteristics, treatment outcomes, and retreatment rates were compared between the two groups over a one-year follow-up period. Results: The best-corrected visual acuity (BCVA) was found to have improved significantly in the IVA/PDT group at every 3-month visit. However, no significant BCVA improvement was observed in the IVA group. A significantly lower retreatment rate and higher dry macula rate were found in the IVA/PDT group than that in the IVA group. In the entire population of the study, a better baseline vision and younger age were associated with better final visual outcomes. Retreatment was associated with poor baseline BCVA and IVA monotherapy. Conclusions: The combination of IVA and PDT may offer superior visual improvement and a higher dry macula rate compared to IVA monotherapy in the treatment of PCV patients while requiring fewer retreatments over 12 months.

Mavacamten in real-life practice: Initial experience at a hypertrophic cardiomyopathy centre.

In clinical trials, mavacamten reduced left ventricular outflow tract obstruction (LVOTO) and improved symptoms in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). We aimed to share our real-world experience with the efficacy and safety of mavacamten in this patient population. This retrospective, single-centre study included patients with symptomatic oHCM from March 2023 to November 2023. Inclusion criteria were oHCM, age >18years, significant LVOTO (gradient >50mmHg at rest or with Valsalva), New York Heart Association (NYHA) class ≥II despite maximally tolerated medical therapy, and left ventricular ejection fraction (LVEF) >55%. Patients were evaluated by echocardiography, NYHA class, electrocardiography and Holter monitor on each monthly visit for 3months. A total of 31 patients were included in this study. The mean (SD) age was 58 (16.5) years, and 14 (45%) were female. Mean provoked left ventricular outflow tract gradient (LVOTG) reduced by -49.4mmHg (P<0.001) at 4weeks, -59.2mmHg (P<0.001) at 8weeks, and -60.8mmHg (P<0.001) at 12weeks. Twenty-six of the 31 patients (83.8%) achieved an LVOTG ≤30mmHg at Week 12. No major side effects were reported. Sixty-seven percent experienced ≥2 NYHA class improvements, LVEF remained above 55% and no dose titration was made. Our real-world experience aligns with established mavacamten trial outcomes. Continuous vigilance and longitudinal investigations are needed to further assess potential long-term impacts.

Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort.

There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC). To investigate clinical laboratory markers of SARS-CoV-2 and PASC. Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024). 83 enrolling sites. RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection. Participants completed questionnaires and standard clinical laboratory tests. Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 109 cells/L [95% CI, 264.5 to 267.4 × 109 cells/L]) than participants without known prior infection (275.2 × 109 cells/L [CI, 268.5 to 282.0 × 109 cells/L]), as well as higher mean hemoglobin A1c (HbA1c) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin-creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA1c levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero. Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined. Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC. National Institutes of Health.

Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema

There are reported benefits from vitrectomy for diabetic macular edema (DME); however, data precede anti-vascular endothelial growth therapy (VEGF) therapy, supporting a need to assess the current role of vitrectomy. To determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&E) anti-VEGF injections for diabetic macular edema (DME). This was a single-masked, multicenter randomized clinical trial at 21 sites in the United Kingdom from June 2018 to January 2021, evaluating single eyes of treatment-naive patients with symptomatic vision loss from DME for less than 1 year. Inclusion criteria were best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score greater than 35 (approximate Snellen equivalent, 20/200 or better) and central subfield thickness (CST) greater than 350 μm after 3 monthly intravitreal injections of ranibizumab or aflibercept. Data analysis was performed in July 2023. Patients were randomized 1:1 into vitrectomy plus standard care or standard care alone and further stratified into groups with vs without vitreomacular interface abnormality. Both groups received a T&E anti-VEGF injection regimen with aflibercept, 2 mg, or ranibizumab, 0.5 mg. The vitrectomy group additionally underwent pars plana vitrectomy with epiretinal membrane or ILM peel within 1 month of randomization. Rate of recruitment and distance BCVA. Secondary outcome measures were CST, change in BCVA and CST, number of injections, rate of completed follow-up, and withdrawal rate. Over 32 months, 47 of a planned 100 patients were enrolled; 42 (89%; mean [SD] age, 63 [11] years; 26 [62%] male) completed 12-month follow-up visits. Baseline characteristics appeared comparable between the control (n = 23; mean [SD] age, 66 [10] years) and vitrectomy (n = 24; mean [SD] age, 62 [12] years) groups. No difference in 12-month BCVA was noted between groups, with a 12-month median (IQR) BCVA letter score of 73 (65-77) letters (Snellen equivalent, 20/40) in the control group vs 77 (67-81) letters (Snellen equivalent, 20/32) in the vitrectomy group (difference, 4 letters; 95% CI, -8 to 2; P = .24). There was no difference in BCVA change from baseline (median [IQR], -1 [-3 to 2] letters for the control group vs -2 [-8 to 2] letters for the vitrectomy group; difference, 1 letter; 95% CI, -5 to 7; P = .85). No difference was found in CST changes (median [IQR], -94 [-122 to 9] μm for the control group vs -32 [-48 to 25] μm for the vitrectomy group; difference, 62 μm; 95% CI, -110 to 11; P = .11). Enrollment goals could not be attained. However, with 47 participants, evidence did not support a clinical benefit of vitrectomy plus ILM peeling as an adjunct to a T&E regimen of anti-VEGF therapy for DME. isrctn.org Identifier: ISRCTN59902040.

Family Involvement During Comprehensive Developmental Evaluations: Perspectives of Diverse Mothers.

Early diagnosis and social support postdiagnosis (i.e., family involvement) can lead to improved outcomes for children with autism spectrum disorder (ASD) and other developmental disorders. Children of minority ethnic and racial groups are typically diagnosed later in childhood compared with White children, contributing to disparities in outcomes. Research has not yet explored family involvement during comprehensive developmental evaluations nor accounted for cross-cultural differences in family roles and involvement. This qualitative study sought to characterize the nature and impact of family involvement during the developmental evaluation process among racially and ethnically marginalized mothers of children with developmental delays and possible ASD. Mothers (N = 27) of children who had a positive autism screen during their 18- or 24-month well-child visit but did not receive an ASD diagnosis after comprehensive developmental evaluation participated in individual semi-structured interviews exploring experiences with developmental screening, related services, and family involvement/social support. Qualitative data were transcribed, coded, and analyzed using applied thematic analysis. Data were stratified by partner status (i.e., partnered vs. nonpartnered) to examine differences in support and family involvement across varying family compositions. Three qualitative themes emerged: (1) mothers sought family involvement when making decisions about pursuing developmental evaluations, (2) family involvement affected mothers' navigation of logistical challenges, and (3) mothers involved family members for emotional support. Differences by partner status emerged in themes 1 and 2. Findings highlight benefits of and potential approaches to harnessing family involvement to support parents' navigation of the developmental evaluation process and ultimately improve child outcomes.

Oral Health-Related Quality of Life of Hong Kong Kindergarten Children Receiving Silver Diamine Fluoride Therapy.

The objective of this prospective 12-month observational study is to examine the oral health-related quality of life (OHRQoL) among Hong Kong young children aged 3-4 years old receiving silver diamine fluoride (SDF) therapy for carious upper anterior primary teeth. A parental questionnaire was used to collect each child's sociodemographic background and oral health habits at baseline. Data on parents' satisfaction with their child's dental aesthetics were collected at baseline and during a 12-month visit. The Chinese Early Childhood Oral Health Impact Scale (C-ECOHIS) was used to measure OHRQoL. A trained dentist performed examinations and recorded caries experience (dmft) and oral hygiene (visible plaque index) at baseline and 12 months. SDF was applied to the carious lesions. Out of 286 invited children, 248 (87%, 248/286) participated, and 211 (85%, 211/248) attended the 12-month examination. All SDF-treated carious lesions were discoloured at the 12-month examination. Regression analysis showed that the baseline C-ECOHIS score was associated with dmft (p < 0.001). The baseline and 12-month C-ECOHIS scores were 4.6 ± 5.5 and 5.0 ± 5.6, respectively (p = 0.42). The scores for parental satisfaction with dental aesthetics at baseline and 12 months were 59% to 46% (p < 0.001). Satisfaction was negatively associated with the number of discoloured upper anterior teeth (p < 0.001). In conclusion, SDF discoloured the carious upper anterior teeth of the Hong Kong kindergarten children. However, the discoloured lesions had no significant effects on the OHRQoL of these children. However, more parents became dissatisfied with their child's dental aesthetics after SDF therapy. Hence, clinicians should inform parents well before they perform SDF therapy on children.

Macular thickness and visual acuity are characterized by a quadratic nonlinear relation in previously treated neovascular AMD eyes.

To assess the associations between visual acuity (VA) and retinal thickness in age-related macular degeneration (AMD) eyes treated with anti-vascular endothelial growth factor (VEGF) therapy. Sixty-eight patients with neovascular AMD (68 eyes) undergoing anti-VEGF therapy with two years of follow-up imaging data after the initiation of treatment were retrospectively included. Linear and nonlinear regression analyses with curve fitting estimation were performed to explore the relationship between visual acuity and OCT-based parameters at the 3-month and 24-month follow-up visits. Regression analyses were also performed between visual acuity and the retinal thickness deviation which was calculated as the absolute value of the difference between measured and normative retinal thickness values. The VA was not associated with either foveal (R2 = 0.011 and p = .401 at 3 months; R2 = 0.032 and p = .142 at 24 months) or parafoveal (R2 = 0.045 and p = .081 at 3 months; R2 = 0.050 and p = .055 at 24 months) retinal thicknesses. Compared with the linear models, a quadratic function yielded a relative increase in the R2 coefficients. Conversely, the VA was linearly associated with foveal retinal thickness deviation (R2 = 0.041 and p = .037 at 24 months) and parafoveal retinal thickness deviation (R2 = 0.062 and p = .040 at 3 months; R2 = 0.088 and p = .014 at 24 months) values. Although there was no linear relationship between retinal thickness and VA, a weak but statistically significant linear relationship could be observed when a retinal thickness deviation was considered. This suggests that deviation-based parameters may be beneficial for structure-function correlations in the context of anti-VEGF therapy for neovascular AMD.

Clinical Characteristic and Tear Film Biomarkers After Myopic FS-LASIK: 1-Year Prospective Follow-up.

To assess the long-term (1-year) effect of myopic femtosecond laser-assisted in situ keratomileusis (FSLASIK) on clinical characteristics and tear film biomarkers. Eighty eyes from 80 patients who underwent FSLASIK were evaluated. Ocular surface symptoms and signs were evaluated using specific questionnaires and tests. The corneal nerves and dendritic cells were examined using in vivo confocal microscopy. Corneal sensitivity was evaluated using a Cochet-Bonnet esthesiometer. Tear inflammatory cytokines and neuropeptides were evaluated using Luminex immunoassay. These examinations were performed preoperatively and at 1, 3, 6, and 12 months postoperatively. Seventy-three participants completed all follow-up visits. Following FS-LASIK, ocular symptoms and signs (except Schirmer I test) worsened at 1 month but corneal and conjunctival stainings improved by 3 months. The numbers of dendritic cells and activated dendritic cells increased at the 3-month postoperative visit and recovered to preoperative levels by the 6-month visit. Ocular symptoms and corneal sensitivity recovered to preoperative levels at the 12-month visit. Tear break-up time and corneal nerve morphology were not recovered to preoperative status at the 12-month visit. Interleukin (IL)-1β, IL-17A, tumor necrosis factor-α, and substance P tear levels significantly increased at all postoperative visits compared to preoperative levels. Corneal staining scores positively correlated with tear IL-1β and IL-17A levels, whereas corneal nerve morphology positively correlated with corneal sensitivity and negatively correlated with substance P levels. Although most clinical variables improved at 12 months postoperatively, some tear inflammatory cytokines and substance P remain altered beyond 12 months, indicating that ocular homeostasis is not completely recovered. [J Refract Surg. 2024;40(8):e508-e519.].

Postpartum Depression Screening in Pediatric Primary Care Clinics and Infant Receipt of Preventive or Acute Care

ObjectiveTo evaluate the association between postpartum depression (PPD) screening results in pediatric primary care and subsequent infant preventive and acute care utilization. MethodsThis was a retrospective cohort analysis of 5341 infants born in 2021 whose mothers were screened for PPD at a well-child visit during the first 6 months. Logistic regression was used to examine that association between a positive PPD screen and 1) adherence to the 12-month well-child visit, and 2) any acute care visits (urgent care or emergency department visits) from 6–15 months. The association between PPD screen and number of acute care visits was examined with negative binomial logistic regression. ResultsThe incidence of positive PPD screens was 15.6% in the first 6 months. There was no significant difference in 12-month well-child visit adherence based on PPD screening (adjusted odds ratio (aOR): 0.91; 95% confidence interval (CI): 0.77–1.06; P-value: 0.206). The odds of having any acute care visit were higher among infants whose mothers screened positive for PPD (aOR: 1.2; 95% CI: 1.0–1.3; P-value: 0.009). There was a significant difference in the incidence rate of acute care visits based on PPD screening results (incidence rate ratio: 1.1; 95% CI: 1.0–1.2; P-value: 0.005). ConclusionsScreening positive for PPD was associated with subsequent acute care utilization but not 12-month preventive care. Primary care providers may need to proactively follow-up after acute care visits to ensure both infant health and maternal needs are met, connecting mothers to resources as needed.

Long-Term Impact of Diabetic Retinopathy on Response to Anti-VEGF Treatment in Neovascular AMD.

To explore the long-term effect of diabetic retinopathy on response to anti-vascular endothelial growth factor (VEGF) treatment in age-related macular degeneration-associated type 1 macular neovascularization (MNV) using optical coherence tomography angiography (OCTA). A total of 45 eyes with exudative neovascular age-related macular degeneration (nAMD) with type 1 MNV were included in the analysis. Among them, 24 eyes of 24 patients had no history of diabetes mellitus (DM) in their anamnesis and were assigned to the Not Diabetic group; 21 eyes of 21 patients had mild diabetic retinopathy and were included in the Diabetic group. We considered the following outcome measures: (1) best-corrected visual acuity changes; (2) central macular thickness; (3) MNV lesion area; and (4) MNV flow area. The OCTA acquisitions were performed at the following time points: (1) baseline visit, which corresponded to the day before the first injection; (2) post-loading phase (LP), which was scheduled at 1month after the last LP injection; and (3) 12-month follow-up visit. All morphofunctional parameters showed a significant improvement after the LP and at the 12-month follow-up visit. Specifically, both the Diabetic group and the Not Diabetic group displayed a significant reduction of MNV lesion areas at both the post-LP assessment (P = 0.026 and P = 0.016, respectively) and the 12-month follow-up (P = 0.039 and P = 0.025, respectively). Similarly, the MNV flow area was significantly decreased in both the Diabetic group and the Not Diabetic group at the post-LP assessment (P < 0.001 and P = 0.012, respectively) and at the 12-month follow-up (P = 0.01 and P = 0.035, respectively) compared to baseline. A smaller reduction in the MNV lesion area was observed in the Diabetic group at both the post-LP evaluation (P = 0.015) and the 12-month follow-up (P = 0.032). No other significant differences were found between the groups for the other parameters (P > 0.05). Our results indicated that the Diabetic group exhibited a smaller reduction in MNV lesion area after 12months of anti-VEGF treatment. This highlights the importance of considering diabetic retinopathy as a potential modifier of treatment outcomes in nAMD management, with DM serving as a crucial risk factor during anti-angiogenic treatment.

Treatment simplification to optimize cenobamate effectiveness and tolerability: A real-world retrospective study in Spain.

This study aimed to explore the impact of co-antiseizure medication (co-ASM) optimization on the effectiveness and tolerability of adjunctive cenobamate (CNB) in patients with drug-resistant epilepsy in a real-world setting. This unicentric, retrospective, observational study included adults with focal-onset seizures who had received ≥2 previous ASMs. The main effectiveness endpoints included responder rates and seizure frequency reduction at 3, 6, and 12-month visits. The number of co-ASMs and defined daily dose (DDD) were analyzed at every visit. Safety endpoints included adverse drug reactions (ADRs). Thirty-four patients with a median epilepsy duration of 22 years and a median of 15.5 seizures/month were analyzed. The median number of prior ASMs was 12, and the mean number of co-ASMs was 2.9 (SD 1). There was a reduction in seizure frequency/month from baseline to the last visit (p < 0.0001). Between baseline and the end of the study, the mean number of co-ASMs in the per-protocol (PP) population was reduced from 2.9 to 1.6 (p < 0.0001), and DDD was reduced from 3.6 to 1.4 (p < 0.0001). Sodium channel blockers (carbamazepine and lacosamide) and GABAergic drugs (clobazam) were the agents with the most significant reductions in DDD after 12 months. The percentage of patients in the PP population with ≥3 co-ASMs was reduced from 61.8% at baseline to 14.3% at 12 months; 1 patient was receiving CNB as monotherapy at the last visit. At the last visit, 85.7% of the PP population were ≥50% responders, and 33.3% were seizure-free. The percentage of patients with ADRs in the PP population was 71.9% at 3 months and 52.3% at 12 months. Following rational polytherapy, optimization of co-ASM management during CNB treatment allowed high seizure freedom rates despite meaningful reductions in co-medication, while also achieving both good tolerability and patient satisfaction scores in a highly drug-resistant population. Many patients with epilepsy still have seizures, even after being treated with several different epilepsy drugs. In this study of 34 patients from a Spanish clinic, we show that the epilepsy drug cenobamate can reduce the number of seizures in these patients, even after many other epilepsy drugs have failed. We also show that patients treated with cenobamate can reduce the dose or even stop taking certain other epilepsy drugs. This allows them to simplify their treatment and reduce adverse effects while still keeping control of their epilepsy.

Impact of a community pharmacy-based medication therapy management program on clinical and humanistic outcomes in patients with uncontrolled diabetes: a randomised controlled trial

This study was aimed to evaluate the impact of community pharmacy (CP)-based medication therapy management (MTM) program on clinical and humanistic outcomes in patients with uncontrolled diabetes. An open label, parallel-group randomised controlled trial was undertaken at a community pharmacy in Riyadh city, Kingdom of Saudi Arabia. Patients with a diagnosis of uncontrolled diabetes (HbA1c of ≥ 8%) meeting the eligibility criteria were randomised to receive either the MTM programme provided by pharmacists or standard care. The primary outcome was change in HbA1c over 6 months. Secondary outcomes included: changes in clinical parameters (blood pressure (BP), lipid profile, serum creatinine (SCr) and albumin-to- creatinine ratio (ACR)), types of drug-related problems (DRPs), health service utilization (HSU), adherence, diabetes distress and overall patient satisfaction with the service at 6-month. A sufficiently powered sample of 160 participants with a mean age was 50 years (SD ± 11.9) was recruited. The majority of the patients (68.1%) were male and had diabetes for more than eight years [IQR 3, 14]. After adjusting for baseline HbA1c, compared to the control group, the mean HbA1c level was 0.02% (p = 0.929) and 0.2% (p = 0.47) lower in the intervention arm at 3-month and 6-month respectively. However, these differences were not statistically significant. Nonetheless, within each arm, there was a significant improvement in HbA1c from baseline. Furthermore, the intervention arm demonstrated improvement in BP control (SBP lowered by 3.2 mmHg (p = 0.05) and DBP lowered by 3.8 mmHg (p = 0.008)). During the study period, none of the participants in the intervention group reported hospitalization or ER visits compared to 14 patients in the control group [OR 0.069 (95% CI 0.004, 1.3)]. Patient satisfaction as measured by Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) was significantly higher among MTM program participants compared to standard care (p = 0.00001). Patients in the MTM program were eight times more likely to be adherent compared to the patients in the standard care [OR 7.89 (95% CI 3.6, 17.4)]. MTM program metrics showed that per patient, the pharmacists spent a median of 35 [IQR 30, 44.5] minutes at the initial visit and 20 [IQR 10, 25] minutes during the 6-month visit. The number of DRPs had significantly dropped in the intervention arm at 3 and 6-month (p = 0.0001). In conclusion, CP-based MTM program can improve health outcomes and prevent hospitalisations in patients with diabetes. These findings support the implementation of CP-based MTM services for patients with diabetes in the Kingdom of Saudi Arabia.