Tag: pubmed

Cornea. 2023 Oct 26. doi: 10.1097/ICO.0000000000003413. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to describe the optical and topographic changes after manual superficial keratectomy (MSK) for Salzmann nodular degeneration.

METHODS: This was a descriptive, retrospective study. All patients with a clinical diagnosis of Salzmann nodular degeneration were examined at the Cornea Service of the Instituto Clínico Quirúrgico de Oftalmología (ICQO), Bilbao, Spain, and treated with MSK after presenting ocular discomfort and/or decreased visual acuity. The clinical characteristics (including anterior segment optical coherence tomography and Pentacam topography), treatment regimens, surgical procedures, and outcomes were recorded. Descriptive statistics were constructed using mean ± SD, minimum, maximum, and median. The Shapiro-Wilk normality test was used. The Student t test was used to determine significance.

RESULTS: Ten eyes of 9 patients were included in this study: 6 patients (66.6%) were female and 3 were male (33.3%). The mean age was 62.2 years, and the follow-up time was between 5 and 21 months. The best-corrected visual acuity before MSK was 0.20 LogMAR (median) and improved to 0.10 after the surgical procedure. The mean spherical equivalent was reduced from -0.23 ± 3.39 D preoperatively to -1.3 ± 3.0 D postoperatively. Astigmatism decreased between 0.5 and 3.75 D. Topographic irregularity normalized total root mean square from 11,596.4 ± 6854.01 to 4817.2 ± 2725.68 μm.

CONCLUSIONS: MSK is an effective and safe technique for the treatment of Salzmann nodular degeneration when the Bowman layer is preserved. Anterior segment optical coherence tomography and corneal topography are essential tools for the surgical plan and for the detection of corneal aberrations.

PMID:37889535 | DOI:10.1097/ICO.0000000000003413

JMIR Res Protoc. 2023 Oct 27;12:e46603. doi: 10.2196/46603.

ABSTRACT

BACKGROUND: Many university students experience mental health problems such as anxiety and depression. To support their mental health, a transdiagnostic mobile app intervention has been developed. The intervention provides short exercises rooted in various approaches (eg, positive psychology, mindfulness, self-compassion, and acceptance and commitment therapy) that aim to facilitate adaptive emotion regulation (ER) to help students cope with the various stressors they encounter during their time at university.

OBJECTIVE: The goals of this study are to investigate whether the intervention and its components function as intended and how participants engage with them. In addition, this study aims to monitor changes in distress symptoms and ER skills and identify relevant contextual factors that may moderate the intervention’s impact.

METHODS: A sequential explanatory mixed methods design combining a microrandomized trial and semistructured interviews will be used. During the microrandomized trial, students (N=200) will be prompted via the mobile app twice a day for 3 weeks to evaluate their emotional states and complete a randomly assigned intervention (ie, an exercise supporting ER) or a control intervention (ie, a health information snippet). A subsample of participants (21/200, 10.5%) will participate in interviews exploring their user experience with the app and the completed exercises. The primary outcomes will be changes in emotional states and engagement with the intervention (ie, objective and subjective engagement). Objective engagement will be evaluated through log data (eg, exercise completion time). Subjective engagement will be evaluated through exercise likability and helpfulness ratings as well as user experience interviews. The secondary outcomes will include the distal outcomes of the intervention (ie, ER skills and distress symptoms). Finally, the contextual moderators of intervention effectiveness will be explored (eg, the time of day and momentary emotional states).

RESULTS: The study commenced on February 9, 2023, and the data collection was concluded on June 13, 2023. Of the 172 eligible participants, 161 (93.6%) decided to participate. Of these 161 participants, 137 (85.1%) completed the first phase of the study. A subsample of participants (18/172, 10.5%) participated in the user experience interviews. Currently, the data processing and analyses are being conducted.

CONCLUSIONS: This study will provide insight into the functioning of the intervention and identify areas for improvement. Furthermore, the findings will shed light on potential changes in the distal outcomes of the intervention (ie, ER skills and distress symptoms), which will be considered when designing a follow-up randomized controlled trial evaluating the full-scale effectiveness of this intervention. Finally, the results and data gathered will be used to design and train a recommendation algorithm that will be integrated into the app linking students to relevant content.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05576883; https://www.clinicaltrials.gov/study/NCT05576883.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46603.

PMID:37889525 | DOI:10.2196/46603

JAMA Netw Open. 2023 Oct 2;6(10):e2337001. doi: 10.1001/jamanetworkopen.2023.37001.

ABSTRACT

IMPORTANCE: There is a plethora of treatment options for patients with de Quervain tenosynovitis (DQT), but there are limited data on their effectiveness and no definitive management guidelines.

OBJECTIVE: To assess and compare the effectiveness associated with available treatment options for DQT to guide musculoskeletal practitioners and inform guidelines.

DATA SOURCES: Medline, Embase, PubMed, Cochrane Central, Scopus, OpenGrey.eu, and WorldCat.org were searched for published studies, and the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, The European Union Clinical Trials Register, and the ISRCTN registry were searched for unpublished and ongoing studies from inception to August 2022.

STUDY SELECTION: All randomized clinical trials assessing the effectiveness of any intervention for the management of DQT.

DATA EXTRACTION AND SYNTHESIS: This study was prospectively registered on PROSPERO and conducted and reported per Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta-analyses of Health Care Interventions (PRISMA-NMA) and PRISMA in Exercise, Rehabilitation, Sport Medicine and Sports Science (PERSIST) guidance. The Cochrane Risk of Bias tool and the Grading of Recommendations, Assessment, Development, and Evaluations tool were used for risk of bias and certainty of evidence assessment for each outcome.

MAIN OUTCOMES AND MEASURES: Pairwise and network meta-analyses were performed for patient-reported pain using a visual analogue scale (VAS) and for function using the quick disabilities of the arm, shoulder, and hand (Q-DASH) scale. Mean differences (MD) with their 95% CIs were calculated for the pairwise meta-analyses.

RESULTS: A total of 30 studies with 1663 patients (mean [SD] age, 46 [7] years; 80% female) were included, of which 19 studies were included in quantitative analyses. From the pairwise meta-analyses, based on evidence of moderate certainty, adding thumb spica immobilization for 3 to 4 weeks to a corticosteroid injection (CSI) was associated with statistically but not clinically significant functional benefits in the short-term (MD, 10.5 [95% CI, 6.8-14.1] points) and mid-term (MD, 9.4 [95% CI, 7.0-11.9] points). In the network meta-analysis, interventions that included ultrasonography-guided CSI ranked at the top for pain. CSI with thumb spica immobilization had the highest probability of being the most effective intervention for short- and mid-term function.

CONCLUSIONS AND RELEVANCE: This network meta-analysis found that adding a short period of thumb spica immobilization to CSI was associated with statistically but not clinically significant short- and mid-term benefits. These findings suggest that administration of CSI followed by 3 to 4 weeks immobilization should be considered as a first-line treatment for patients with DQT.

PMID:37889490 | DOI:10.1001/jamanetworkopen.2023.37001

JAMA Netw Open. 2023 Oct 2;6(10):e2339042. doi: 10.1001/jamanetworkopen.2023.39042.

ABSTRACT

IMPORTANCE: School closures and other COVID-19-related restrictions could decrease children’s exposure to speech during important stages of development.

OBJECTIVE: To assess whether significant decreases in exposure to spoken communication found during the initial phase of the COVID-19 pandemic among children using cochlear implants are confirmed for a larger cohort of children and were sustained over the first years of the COVID-19 pandemic.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used datalogs collected from children with cochlear implants during clinical visits to a tertiary pediatric hospital in Toronto, Ontario, Canada, from January 1, 2018, to November 11, 2021. Children with severe to profound hearing loss using cochlear implants were studied because their devices monitored and cataloged levels and types of sounds during hourly use per day (datalogs) and because their hearing and spoken language development was particularly vulnerable to reduced sound exposure. Statistical analyses were conducted between January 2022 and August 2023.

MAIN OUTCOMES AND MEASURES: Daily hours of sound were captured by the cochlear implant datalogging system and categorized into 6 auditory scene categories, including speech and speech-in-noise. Time exposed to speech was calculated as the sum of daily hours in speech and daily hours in speech-in-noise. Residual hearing in the ear without an implant of children with unilateral cochlear implants was measured by pure tone audiometry. Mixed-model regression analyses revealed main effects with post hoc adjustment of 95% CIs using the Satterthwaite method.

RESULTS: Datalogs (n = 2746) from 262 children (137 with simultaneous bilateral cochlear implants [74 boys (54.0%); mean (SD) age, 5.8 (3.5 years)], 38 with sequential bilateral cochlear implants [24 boys (63.2%); mean (SD) age, 9.1 (4.2) years], and 87 with unilateral cochlear implants [40 boys (46.0%); mean (SD) age, 7.9 (4.6) years]) who were preschool aged (n = 103) and school aged (n = 159) before the COVID-19 pandemic were included in analyses. There was a slight increase in use among preschool-aged bilateral cochlear implant users through the pandemic (early pandemic, 1.4 h/d [95% CI, 0.3-2.5 h/d]; late pandemic, 2.3 h/d [95% CI, 0.6-4.0 h/d]) and little change in use among school-aged bilateral cochlear implant users (early pandemic, -0.6 h/d [95% CI, -1.1 to -0.05 h/d]; late pandemic, -0.3 h/d [95% CI, -0.9 to 0.4 h/d]). However, use decreased during the late pandemic period among school-aged children with unilateral cochlear implants (-1.8 h/d [95% CI,-3.0 to -0.6 h/d]), particularly among children with good residual hearing in the ear without an implant. Prior to the pandemic, children were exposed to speech for approximately 50% of the time they used their cochlear implants (preschool-aged children: bilateral cochlear implants, 46.6% [95% CI, 46.5%-47.2%] and unilateral cochlear implants, 52.1% [95% CI, 50.7%-53.5%]; school-aged children: bilateral cochlear implants, 47.6% [95% CI, 46.8%-48.4%] and unilateral cochlear implants, 51.0% [95% CI, 49.4%-52.6%]). School-aged children in both groups experienced significantly decreased speech exposure in the early pandemic period (bilateral cochlear implants, -12.1% [-14.6% to -9.4%]; unilateral cochlear implants, -15.5% [-20.4% to -10.7%]) and late pandemic periods (bilateral cochlear implants, -5.3% [-8.0% to -2.6%]; unilateral cochlear implants, -11.2% [-15.3% to -7.1%]) compared with the prepandemic baseline.

CONCLUSIONS AND RELEVANCE: This cohort study using datalogs from children using cochlear implants suggests that a sustained reduction in children’s access to spoken communication was found during more than 2 years of COVID-19 pandemic-related lockdowns and school closures.

PMID:37889489 | DOI:10.1001/jamanetworkopen.2023.39042

JAMA Netw Open. 2023 Oct 2;6(10):e2340030. doi: 10.1001/jamanetworkopen.2023.40030.

ABSTRACT

IMPORTANCE: Testosterone deficiency causes mild anemia. Whether testosterone replacement therapy (TRT) can correct anemia or prevent the development of anemia in men with hypogonadism remains incompletely understood.

OBJECTIVE: To assess the efficacy of TRT in correcting anemia in men with hypogonadism and anemia, and reducing the risk of developing anemia in those without anemia.

DESIGN, SETTING, AND PARTICIPANTS: This randomized, placebo-controlled trial included men with hypogonadism at 316 US sites enrolled between May 2018 and February 2022. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study, which evaluated the effect of TRT on major adverse cardiovascular events in middle-aged and older men with hypogonadism. Eligible participants were aged 45 to 80 years, with 2 testosterone concentration results below 300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk. The last study visit took place in January 2023. Data were analyzed between March and August 2023.

INTERVENTION: Participants were randomized with stratification for preexisting CVD to 1.62% testosterone gel or placebo gel daily for the study duration.

MAIN OUTCOMES AND MEASURES: Proportion of participants with anemia (hemoglobin below 12.7 g/dL) whose anemia remitted (hemoglobin 12.7 g/dL or above) over the study duration. Secondary end points included incidence of anemia among men who were not anemic. Binary end points were analyzed using repeated-measures log-binomial regression.

RESULTS: A total of 5204 men were included, 815 with anemia (mean [SD] age, 64.8 [7.7] years; 247 Black [30.3%], 544 White [66.7%], 24 other [2.9%]) and 4379 without anemia (mean [SD] age, 63.0 [7.9] years; 629 Black [14.4%], 3603 White [82.3%], 147 other [3.4%]). Anemia corrected in a significantly greater proportion of testosterone-treated than placebo-treated men at 6 months (143 of 349 [41.0%] vs 103 of 375 [27.5%]), 12 months (152 of 338 [45.0%] vs 122 of 360 [33.9%]), 24 months (124 of 290 [42.8%] vs 95 of 307 [30.9%]), 36 months (94 of 216 [43.5%] vs 76 of 229 [33.2%]), and 48 months (41 of 92 [44.6%] vs 38 of 97 [39.2%]) (P = .002). Among participants without anemia, a significantly smaller proportion of testosterone-treated men developed anemia than placebo-treated men. Changes in hemoglobin were associated with changes in energy level.

CONCLUSIONS AND RELEVANCE: In middle-aged and older men with hypogonadism and anemia, TRT was more efficacious than placebo in correcting anemia. Among men who were not anemic, a smaller proportion of testosterone-treated men developed anemia than placebo-treated men.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03518034.

PMID:37889486 | DOI:10.1001/jamanetworkopen.2023.40030

JAMA Health Forum. 2023 Oct 6;4(10):e233648. doi: 10.1001/jamahealthforum.2023.3648.

ABSTRACT

IMPORTANCE: During the COVID-19 pandemic, a large fraction of mental health care was provided via telemedicine. The implications of this shift in care for use of mental health service and quality of care have not been characterized.

OBJECTIVE: To compare changes in care patterns and quality during the first year of the pandemic among Medicare beneficiaries with serious mental illness (schizophrenia or bipolar I disorder) cared for at practices with higher vs lower telemedicine use.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, Medicare fee-for-service beneficiaries with schizophrenia or bipolar I disorder were attributed to specialty mental health practices that delivered the majority of their mental health care in 2019. Practices were categorized into 3 groups based on the proportion of telemental health visits provided during the first year of the pandemic (March 2020-February 2021): lowest use (0%-49%), middle use (50%-89%), or highest use (90%-100%). Across the 3 groups of practices, differential changes in patient outcomes were calculated from the year before the pandemic started to the year after. These changes were also compared with differential changes from a 2-year prepandemic period. Analyses were conducted in November 2022.

EXPOSURE: Practice-level use of telemedicine during the first year of the COVID-19 pandemic.

MAIN OUTCOMES AND MEASURES: The primary outcome was the total number of mental health visits (telemedicine plus in-person) per person. Secondary outcomes included the number of acute hospital and emergency department encounters, all-cause mortality, and quality outcomes, including adherence to antipsychotic and mood-stabilizing medications (as measured by the number of months of medication fills) and 7- and 30-day outpatient follow-up rates after discharge for a mental health hospitalization.

RESULTS: The pandemic cohort included 120 050 Medicare beneficiaries (mean [SD] age, 56.5 [14.5] years; 66 638 females [55.5%]) with serious mental illness. Compared with prepandemic changes and relative to patients receiving care at practices with the lowest telemedicine use: patients receiving care at practices in the middle and highest telemedicine use groups had 1.11 (95% CI, 0.45-1.76) and 1.94 (95% CI, 1.28-2.59) more mental health visits per patient per year (or 7.5% [95% CI, 3.0%-11.9%] and 13.0% [95% CI, 8.6%-17.4%] more mental health visits per year, respectively). Among patients of practices with middle and highest telemedicine use, changes in adherence to antipsychotic and mood-stabilizing medications were -0.4% (95% CI, -1.3% to 0.5%) and -0.1% (95% CI, -1.0% to 0.8%), and hospital and emergency department use for any reason changed by 2.4% (95% CI, -1.5% to 6.2%) and 2.8% (95% CI, -1.2% to 6.8%), respectively. There were no significant differential changes in postdischarge follow-up or mortality rates according to the level of telemedicine use.

CONCLUSIONS AND RELEVANCE: In this cohort study of Medicare beneficiaries with serious mental illness, patients receiving care from practices that had a higher level of telemedicine use during the COVID-19 pandemic had more mental health visits per year compared with prepandemic levels, with no differential changes in other observed quality metrics over the same period.

PMID:37889483 | DOI:10.1001/jamahealthforum.2023.3648

Langmuir. 2023 Oct 27. doi: 10.1021/acs.langmuir.3c02272. Online ahead of print.

ABSTRACT

Droplets made of liquid perfluorocarbon undergo a phase transition and transform into microbubbles when triggered by ultrasound of intensity beyond a critical threshold; this mechanism is called acoustic droplet vaporization (ADV). It has been shown that if the intensity of the signal coming from high ultrasonic harmonics are sufficiently high, superharmonic focusing is the mechanism leading to ADV for large droplets (>3 μm) and high frequencies (>1.5 MHz). In such a scenario, ADV is initiated due to a nucleus occurring at a specific location inside the droplet volume. But the question on what induces ADV in the case of nanometer-sized droplets and/or at low ultrasonic frequencies (<1.5 MHz) still remains. We investigated ADV of perfluorohexane (PFH) nano- and microdroplets at a frequency of 1.1 MHz and at conditions where there is no superharmonic focusing. Three types of droplets produced by microfluidics were studied: plain PFH droplets, PFH droplets containing many nanometer-sized water droplets, and droplets made of a PFH corona encapsulating a single micron-sized water droplet. The probability to observe a vaporization event was measured as a function of acoustic pressure. As our experiments were performed on droplet suspensions containing a population of monodisperse droplets, we developed a statistical model to extrapolate, from our experimental curves, the ADV pressure thresholds in the case where only one droplet would be insonified. We observed that the value of ADV pressure threshold decreases as the radius of a plain PFH droplet increases. This value was further reduced when a PFH droplet encapsulates a micron-sized water droplet, while the encapsulation of many nanometer-sized water droplets did not modify the threshold. These results cannot be explained by a model of homogeneous nucleation. However, we developed a heterogeneous nucleation model, where the nucleus appears at the surface in contact with PFH, that successfully predicts our experimental ADV results.

PMID:37889478 | DOI:10.1021/acs.langmuir.3c02272

Cerebellum. 2023 Oct 27. doi: 10.1007/s12311-023-01621-6. Online ahead of print.

ABSTRACT

Although a large array of biomarkers have been investigated in Friedreich’s ataxia (FRDA) trials, the optimal biomarker for assessing disease progression or therapeutic benefit has yet to be identified. We searched PubMed, MEDLINE, and EMBASE databases up to June 2023 for any original study (with ≥ 5 participants and ≥ 2 months’ follow-up) reporting the effect of therapeutic interventions on any clinical, cardiac, biochemical, patient-reported outcome measures, imaging, or neurophysiologic biomarker. We also explored the biomarkers’ ability to detect subtle disease progression in untreated patients. The pooled standardized mean difference (SMD) was calculated using a random-effects model. The study’s protocol was registered in PROSPERO (CRD42022319196). In total, 43 studies with 1409 FRDA patients were included in the qualitative synthesis. A statistically significant improvement was observed in Friedreich Ataxia Rating Scale scores [combining Friedreich Ataxia Rating Scale (FARS) and modified FARS (mFARS): SMD = – 0.32 (- 0.62 to – 0.02)] following drugs that augment mitochondrial function in a sensitivity analysis. Left ventricular mass index (LVMI) was improved significantly [SMD = – 0.34 (- 0.5 to – 0.18)] after 28.5 months of treatment with drugs that augment mitochondrial function. However, LVMI remained stable [SMD = 0.05 (- 0.3 to 0.41)] in untreated patients after 6-month follow-up. None of the remaining biomarkers changed significantly following any treatment intervention nor during the natural disease progression. Nevertheless, clinical implications of these results should be interpreted with caution because of low to very low quality of evidence. Further randomized controlled trials of at least 24 months’ duration using a biomarker toolbox rather than a single biomarker are warranted.

PMID:37889470 | DOI:10.1007/s12311-023-01621-6

Radiol Phys Technol. 2023 Oct 27. doi: 10.1007/s12194-023-00750-1. Online ahead of print.

ABSTRACT

The objective is to evaluate the performance of computational image classification for indeterminate pulmonary nodules (IPN) chronologically detected by CT scan. Total 483 patients with 670 abnormal pulmonary nodules, who were taken chest thin-section CT (TSCT) images at least twice and resected as suspicious nodules in our hospital, were enrolled in this study. Nodular regions from the initial and the latest TSCT images were cut manually for each case, and approached by Python development environment, using the open-source cv2 library, to measure the nodular change rate (NCR). These NCRs were statistically compared with clinico-pathological factors, and then, this discriminator was evaluated for clinical performance. NCR showed significant differences among the nodular consistencies. In terms of histological subtypes, NCR of invasive adenocarcinoma (ADC) were significantly distinguishable from other lesions, but not from minimally invasive ADC. Only for cancers, NCR was significantly associated with loco-regional invasivity, p53-immunoreactivity, and Ki67-immunoreactivity. Regarding Epidermal Growth Factor Receptor gene mutation of ADC-related nodules, NCR showed a significant negative correlation. On staging of lung cancer cases, NCR was significantly increased with progression from pTis-stage 0 up to pT1b-stage IA2. For clinical shared decision-making (SDM) whether urgent resection or watchful-waiting, receiver operating characteristic (ROC) analysis showed that area under the ROC curve was 0.686. For small-sized IPN detected by CT scan, this approach shows promise as a potential navigator to improve work-up for life-threatening cancer screening and assist SDM before surgery.

PMID:37889460 | DOI:10.1007/s12194-023-00750-1

Sports Med. 2023 Oct 27. doi: 10.1007/s40279-023-01950-w. Online ahead of print.

ABSTRACT

BACKGROUND: Injuries are common in adult recreational athletes. Exercise-based injury prevention programmes offer the potential to reduce the risk of injury and have been a popular research topic. Yet, syntheses and meta-analyses on the effects of exercise-based injury prevention programmes for adult recreational athletes are lacking.

OBJECTIVES: We aimed to synthesise and quantify the pooled intervention effects of exercise-based injury prevention programmes delivered to adults who participate in recreation sports.

METHODS: Studies were eligible for inclusion if they included adult recreational athletes (aged > 16 years), an exercise-based intervention and used a randomised controlled trial design. Exclusion criteria were studies without a control group, studies using a non-randomised design and studies including participants who were undertaking activity mandatory for their occupation. Eleven literature databases were searched from earliest record, up to 9 June, 2022. The Physiotherapy Evidence Database (PEDro) scale was used to assess the risk of bias in all included studies. Reported risk statistics were synthesised in a random-effects meta-analysis to quantify pooled treatment effects and associated 95% confidence intervals and prediction intervals.

RESULTS: Sixteen studies met the criteria. Risk statistics were reported as risk ratios [RRs] (n = 12) or hazard ratios [HRs] (n = 4). Pooled estimates of RRs and HRs were 0.94 (95% confidence interval 0.80-1.09) and 0.65 (95% confidence interval 0.39-1.08), respectively. Prediction intervals were 0.80-1.09 and 0.16-2.70 for RR and HR, respectively. Heterogeneity was very low for RR studies, but high for HR studies (tau = 0.29, I² = 81%). There was evidence of small study effects for RR studies, evidenced by funnel plot asymmetry and Egger’s test for small study bias: – 0.99 (CI – 2.08 to 0.10, p = 0.07).

CONCLUSIONS: Pooled point estimates were suggestive of a reduced risk of injury in intervention groups. Nevertheless, these risk estimates were insufficiently precise, too heterogeneous and potentially compromised by small study effects to arrive at any robust conclusion. More large-scale studies are required to clarify whether exercise-based injury prevention programmes are effective in adult recreational athletes.

CLINICAL TRIAL REGISTRATION: The protocol for this review was prospectively registered in the PROSPERO database (CRD42021232697).

PMID:37889449 | DOI:10.1007/s40279-023-01950-w