Tag: nevin manimala

JMIR Mhealth Uhealth. 2023 Nov 15;11:e46237. doi: 10.2196/46237.

ABSTRACT

BACKGROUND: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app’s effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses.

OBJECTIVE: This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account for nonadherence and how appropriate are their methods?

METHODS: We searched the Food and Drug Administration’s registration database for registrations of repeated-use, patient-facing SaMD therapeutics. For each such registration, we searched ClinicalTrials.gov, company websites, and MEDLINE for the corresponding clinical trial and study articles through March 2022. Adherence and engagement data were summarized for each of the 24 identified articles, corresponding to 10 SaMD therapeutics. Each article was analyzed with a framework developed using the Cochrane risk-of-bias questions to estimate the potential effects of imperfect adherence on SaMD effectiveness. This review, funded by the Richard King Mellon Foundation, is registered on the Open Science Framework.

RESULTS: We found that although most articles (23/24, 96%) reported collecting information about SaMD therapeutic engagement, of the 20 articles for apps with prescribed use, only 9 (45%) reported adherence information across all aspects of prescribed use: 15 (75%) reported metrics for the initiation of therapeutic use, 16 (80%) reported metrics reporting adherence between the initiation and discontinuation of the therapeutic (implementation), and 4 (20%) reported the discontinuation of the therapeutic (persistence). The articles varied in the reported metrics. For trials that reported adherence or engagement, there were 4 definitions of initiation, 8 definitions of implementation, and 4 definitions of persistence. All articles studying a therapeutic with a prescribed use reported effectiveness estimates that might have been affected by nonadherence; only a few (2/20, 10%) used methods appropriate to evaluate efficacy.

CONCLUSIONS: This review identifies 5 areas for improving future SaMD trials and studies: use consistent metrics for reporting adherence, use reliable adherence metrics, preregister analyses for observational studies, use less biased efficacy analysis methods, and fully report statistical methods and assumptions.

PMID:37966871 | DOI:10.2196/46237

J Telemed Telecare. 2023 Nov 15:1357633X231211355. doi: 10.1177/1357633X231211355. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Telemedicine interventions have emerged as a promising solution to improve medication adherence by providing remote support and monitoring of patients with mental disorders. This study aims to investigate the effectiveness of telemedicine interventions in enhancing medication adherence among patients with mental disorders.

METHODS: PubMed, Scopus, and Web of Science were searched systematically. After deleting the double-included studies, two researchers independently selected articles and extracted data using a standardized data collection form. The risk of bias in the included studies was assessed using the Mixed Methods Appraisal Tool. The intervention effects were combined using a random effects model. Standardized mean differences (Hedges’s g) between the treatment and control groups were calculated. Heterogeneity variance was estimated using the Q test and I² statistic. The analysis was performed in Stata version 17.0.

RESULTS: Out of the 1088 articles retrieved, nine studies were included in the analysis. Overall, telemedicine interventions demonstrated a statistically significant improvement in medication adherence among patients with mental disorders (Hedges’ g = 0.25, 95% confidence interval: 0.12-0.38, p-value: < 0.01). The type of mental disorder was a significant moderator of the heterogeneity between studies (p = 0.022).

CONCLUSION: Telemedicine interventions have a positive impact on medication adherence in patients with mental disorders by offering remote support and monitoring. Integrating telemedicine into mental healthcare can enhance overall adherence rates, leading to improved management of mental disorders.

PMID:37966845 | DOI:10.1177/1357633X231211355

JAMA Netw Open. 2023 Nov 1;6(11):e2343429. doi: 10.1001/jamanetworkopen.2023.43429.

ABSTRACT

IMPORTANCE: Neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia (TH) frequently experience seizures, which are associated with adverse outcomes. Efforts to rapidly identify seizures and reduce seizure burden may positively change neurologic and neurodevelopmental outcomes.

OBJECTIVE: To describe the onset, treatment, and evolution of seizures in a large cohort of newborns with HIE during TH assisted by a telehealth model and remote neuromonitoring approach.

DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, observational, multicenter cohort study performed between July 2017 and December 2021 in 32 hospitals in Brazil. Participants were newborns with HIE meeting eligibility criteria and receiving TH. Data were analyzed from November 2022 to April 2023.

EXPOSURE: Infants with HIE receiving TH were remotely monitored with 3-channel amplitude-integrated electroencephalography (aEEG) including raw tracing and video imaging, and bedside clinicians received assistance from trained neonatologists and neurologists.

MAIN OUTCOMES AND MEASURES: Data on modified Sarnat examination, presence, timing and seizure type, aEEG background activity, sleep-wake cycling, and antiepileptic drugs used were collected. Descriptive statistical analysis was used with independent t test, χ2, Mann-Whitney test, and post hoc analyses applied for associations.

RESULTS: A total of 872 cooled newborns were enrolled; the median (IQR) gestational age was 39 (38-40) weeks, 518 (59.4%) were male, and 59 (6.8%) were classified as having mild encephalopathy by modified Sarnat examination, 504 (57.8%) as moderate, and 180 (20.6%) as severe. Electrographic seizures were identified in 296 newborns (33.9%), being only electrographic in 213 (71.9%) and clinical followed by electroclinical uncoupling in 50 (16.9%). Early abnormal background activity had a significant association with seizures. Infants with flat trace had the highest rate of seizures (58 infants [68.2%]) and the greatest association with the incidence of seizures (odds ratio [OR], 12.90; 95% CI, 7.57-22.22) compared with continuous normal voltage. The absence of sleep-wake cycling was also associated with a higher occurrence of seizures (OR, 2.22; 95% CI, 1.67-2.96). Seizure onset was most frequent between 6 and 24 hours of life (181 infants [61.1%]); however, seizure occurred in 34 infants (11.5%) during rewarming. A single antiepileptic drug controlled seizures in 192 infants (64.9%). The first line antiepileptic drug was phenobarbital in 294 (99.3%).

CONCLUSIONS AND RELEVANCE: In this cohort study of newborns with HIE treated with TH, electrographic seizure activity occurred in 296 infants (33.9%) and was predominantly electrographic. Seizure control was obtained with a single antiepileptic drug in 192 infants (64.9%). These findings suggest neonatal neurocritical care can be delivered at remote limited resource hospitals due to innovations in technology and telehealth.

PMID:37966836 | DOI:10.1001/jamanetworkopen.2023.43429

JAMA Dermatol. 2023 Nov 15. doi: 10.1001/jamadermatol.2023.4445. Online ahead of print.

ABSTRACT

CLINICAL QUESTION: What are the most effective systemic medications to treat plaque psoriasis?

BOTTOM LINE: The most effective drugs for psoriasis were infliximab, bimekizumab, ixekizumab, and risankizumab, and the clinical effectiveness was similar when these 4 drugs were compared against one another. No statistically significant differences in serious adverse events were identified in any of the drugs compared with placebo. The main limitations of this meta-analysis include the lack of assessment of clinical effectiveness beyond 52 weeks and the lack of safety assessments for nonserious adverse events.

PMID:37966815 | DOI:10.1001/jamadermatol.2023.4445

Opt Lett. 2023 Nov 15;48(22):6027-6030. doi: 10.1364/OL.502344.

ABSTRACT

Optical measurements often exhibit mixed Poisson-Gaussian noise statistics, which hampers the image quality, particularly under low signal-to-noise ratio (SNR) conditions. Computational imaging falls short in such situations when solely Poissonian noise statistics are assumed. In response to this challenge, we define a loss function that explicitly incorporates this mixed noise nature. By using a maximum-likelihood estimation, we devise a practical method to account for a camera readout noise in gradient-based ptychography optimization. Our results, based on both experimental and numerical data, demonstrate that this approach outperforms the conventional one, enabling enhanced image reconstruction quality under challenging noise conditions through a straightforward methodological adjustment.

PMID:37966780 | DOI:10.1364/OL.502344

Spine Deform. 2023 Nov 15. doi: 10.1007/s43390-023-00782-y. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to examine the changes in thoracolumbar kyphosis (TLK) following correction surgery in patients with Lenke type 5C adolescent idiopathic scoliosis (AIS) and to evaluate its influence on postoperative spinal alignment and clinical outcomes.

METHODS: Sixty-six patients with Lenke type 5C AIS were included and followed up for a minimum of 5 years after surgery. First, the patients were divided into two groups according to the preoperative TLK angle (Study 1; Kyphosis and Lordosis group). The patients were further classified into two groups according to the presence or absence of postoperative changes in TLK (Study 2; Changed and Maintained groups). Finally, the outcome variables were compared between these groups and analyzed for spinal alignment and clinical outcomes.

RESULTS: In Study 1, patients demonstrated a significant kyphotic change in the Lordosis group and a significant lordotic change in the Kyphosis group postoperatively. No statistically significant differences were found between the two groups when comparing the pre- and postoperative coronal and sagittal alignment. In Study 2, there were no statistically significant differences between the Changed and the Maintained groups in each spinal alignment pre- and postoperatively. Each domain of the Scoliosis Research Society 22-item questionnaire remained unchanged at 5 years postoperation.

CONCLUSION: In many patients with Lenke type 5C AIS, TLK changed significantly and approached 0° after surgery. However, the magnitude of the preoperative TLK and the presence or absence of improvement did not affect postoperative spinal alignment. Furthermore, the patients had satisfactory clinical outcomes irrespective of TLK modification.

LEVEL OF EVIDENCE: III.

PMID:37966710 | DOI:10.1007/s43390-023-00782-y

Ophthalmol Ther. 2023 Nov 15. doi: 10.1007/s40123-023-00849-z. Online ahead of print.

ABSTRACT

INTRODUCTION: With advancements in imaging technology, researchers have been able to identify more distinctive imaging features of central serous chorioretinopathy (CSC). However, existing research primarily concentrates on young patients aged 50 years and below, leaving a dearth of studies on elderly CSC patients. Previous studies indicate that elderly CSC patients may exhibit unique imaging characteristics and have a clinical prognosis that significantly differs from younger patients. This study aimed to evaluate the characteristics of retina, choroid structure, and blood flow in elderly patients with chronic CSC (cCSC) examined multimode imaging and try to find new pathogenesis information of it.

METHODS: Using a cut-off age of 50 years, patients with chronic central serous chorioretinopathy were divided into two groups: older and younger. The control group consisted of 40 healthy individuals, with their right eyes assigned. Various clinical features were recorded, including the incidence of ellipsoid zone rupture (EZ-), fibrin in the subretinal fluid (SRF), pachydrusen, subretinal drusenoid deposits (SDD), pigment epithelial detachment (PED), double-layer sign (DLS), and choroidal lipid globule cavern. Measurements were taken for the thickness of the outer nuclear layer (ONL), the length of the extended outer photoreceptor segment (POS), the height and width of SRF, the vascular density of each layer of the retinal capillary plexus, the central macular thickness (CMT), and the subfoveal choroidal thickness (SFCT).

RESULTS: The proportion of females in the elderly group (43.75%) was significantly higher than that in the youth group (22.41%) (p = 0.034). The degree of hyperopia in the elderly group (1.03 ± 0.73) was higher than that in the youth group (0.26 ± 1.06), with a significant difference in BCVA (p = 0.05). The thickness of SFCT, CMT, ONL in the elderly group, and the length of photoreceptor outer segment in the elderly group were thinner than those in the youth group (p < 0.05). Choroidal capillary perfusion area (CCPA), macular area, and paramacular area were lower in the elderly group than those in the youth group in the full scan range (p < 0.05). The blood flow densities of deep capillary plexus (DCP), intermediate capillary plexus (ICP), and superficial capillary plexus (SCP) in the whole scan range, macular area, and paramacular area were lower in the elderly group than in the youth group, but the differences were not statistically significant.

CONCLUSIONS: In conclusion, our data suggest that elderly patients with cCSC may experience different disease outcomes. Elderly cCSC patients exhibit less gender bias, poorer vision, more severe structural damage and ischemia in the choroid and retina, and have a higher risk of developing choroidal neovascularization.

PMID:37966697 | DOI:10.1007/s40123-023-00849-z

Biol Trace Elem Res. 2023 Nov 15. doi: 10.1007/s12011-023-03934-3. Online ahead of print.

ABSTRACT

The aim of this systematic review and meta-analysis was, for the first time, to explore whether postpartum maternal iodine status or supplementation is associated with thyroid function after delivery. The MEDLINE/PubMed, Web of Science, Embase, and Scopus were searched up to December 2021 to identify relevant studies. The pooled mean thyroid stimulating hormone (TSH), free thyroxine (fT4), and thyroxine (T4) concentrations and 95% confidence intervals (CIs) were estimated based on maternal urinary iodine concentration (UIC) (< 50, 50-100, 100-200, and > 200 µg/L) or breast milk iodine concentration (BMIC) (< 100 µg/L vs. ≥ 100 µg/L) during postpartum. A fixed/random effects model was used based on the absence/presence of heterogeneity, respectively. The study is registered with PROSPERO, number CRD42022336145. A total of 2175 studies were identified, of which 18 were eligible for the meta-analysis. The pooled values for TSH, fT4, and T4 concentrations in all subgroups were within the normal range; however, except for TSH, comparing the 95% CI showed no statistically significant difference among different subgroups. The pooled mean for TSH concentration in women with UIC > 200 µg/L was 2.23 mIU/L, whereas the corresponding values in women with UIC < 50, 50-100 and 100-200 µg/L were 0.56, 0.56 and 0.95 mIU/L, respectively. Thyroid hormones in women with BMIC < 100 µg/L and ≥ 100 µg/L were within the normal range. Iodine supplementation during postpartum was not associated with any differences in thyroid parameters, compared to non-supplemented women. In conclusion, iodine status or supplementation had no effect on thyroid hormones in postpartum women.

PMID:37966688 | DOI:10.1007/s12011-023-03934-3

Mol Neurobiol. 2023 Nov 15. doi: 10.1007/s12035-023-03670-8. Online ahead of print.

ABSTRACT

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social disorder and stereotypical behavior, and its incidence rate is increasing yearly. It is considered that acritical period for the prognosis of young children with ASD exists, thus early treatment is crucial. Swimming, due to its comforting effect, is often used to induce enthusiasm in young children for completing activities and has a good effect in the treatment of ASD, but the effective path of swimming has yet to be reported. The intestinal microbiota of ASD patients and animal models has been reported to be different from that of healthy controls, and these changes may affect the brain environment. Therefore, whether the intestinal microbiota is involved in the treatment of ASD by early swimming is our concern. In this study, we used 8-day old Shank3 gene knockout rats with 8 weeks of early load swimming training and conducted behavioral, small intestine morphology, and intestinal content sequencing after training. The results showed that early load swimming significantly reduced the stereotyped and anxious behaviors of Shank3^-/- rats, increased their muscle strength, increased the length of intestinal villi and the width of the muscular layer after Shank3 knockout, and affected the abundance of intestinal microorganisms. The abundances with statistical significance were Lactobacillus, Lachnospiraceae, and Alloprevotella. To further confirm the role of intestinal microorganisms in it, we designed a 14-day intestinal stool transplantation experiment. Fecal microbiota transplantation demonstrated that load swimming can significantly reduce the anxiety behavior of Shank3 rats, increase their muscle strength, change the structure of the small intestine, and affect the abundance of intestinal contents. The abundance of Epsilonbateraeota, Prevotella, and Bacteroides significantly changed after transplantation. Our findings confirm the possibility of early load swimming therapy for individuals with ASD and explain that the intestinal microbiota is a key pathway for early exercise therapy for patients with ASD.

PMID:37966684 | DOI:10.1007/s12035-023-03670-8

Support Care Cancer. 2023 Nov 15;31(12):700. doi: 10.1007/s00520-023-08179-3.

ABSTRACT

PURPOSE: To evaluate the effectiveness and acceptability of a 6-week acceptance and commitment therapy (ACT)-based group programme on participants’ fear of cancer recurrence (FCR), quality of life (QoL), psychological distress and psychological flexibility at the end of the programme and 12-week follow-up.

METHODS: A one-group, post-test service evaluation of a real-world psychological programme was carried out to evaluate collected outcome measures and attendance for a total of 21 groups facilitated between 2017 and 2019. Participants were breast cancer survivors who attended a 6-week group programme led by NHS clinicians. Descriptive statistics and repeated measures ANOVA analyses were carried out for each outcome measure. Attendance levels were examined to assess acceptability.

RESULTS: A total of 97 group participants who had completed curative treatment for breast cancer took part. Of whom, 89% completed at least 4 of the 6 weekly group sessions and 76% attended the 12-week follow-up session. Eighty-four (87%) participants returned outcome measures at all three time points relative to group participation (T1 = pre, T2 = post T3 = 12-week follow-up). Group participants were female, mean age 51.9 years. FCR was highest at T1 (mean 25.2, SD 4.7), reduced T2 (mean 21.2, SD 5.4) and further lowered T3 (mean 19.5, SD 6.2). This difference was statistically significant (p < 0.001). QoL was lowest at T1 (mean 62.4, SD 15.7), increased T2 (mean 71.7, SD 18.1) and further increased at T3 (mean 75.9, SD 17.5). This difference was statistically significant (p < 0.001). Psychological distress measures were shown to reduce, and psychological flexibility increased.

CONCLUSIONS: This real-world evaluation of an ACT-based group programme led to improvements in FCR, QoL, psychological distress and psychological flexibility in this population. This evaluation provides basis for further investigation to determine if these results can be replicated by controlled research design across diverse populations.

PMID:37966674 | DOI:10.1007/s00520-023-08179-3