Tag: pubmed

PLoS One. 2023 Nov 15;18(11):e0289289. doi: 10.1371/journal.pone.0289289. eCollection 2023.

ABSTRACT

INTRODUCTION: The healthy plate model (HPM) is a practical guide to modulate the portion of staple food in main meals, subsequently affecting the risks associated with Non-communicable Diseases include type2 diabetes mellitus (T2DM).

OBJECTIVE: This study investigated the effectiveness of health information and the healthy plate model on cardio-metabolic risk factors, knowledge and attitude towards T2DM prevention measures.

METHODS: A pre-post analysis, as part of a cluster randomized trial with street food vendors and their customers, was implemented in three randomly selected districts in Dar es Salaam, Tanzania. Two vendor-customer clusters each with 15 and more vendors from each district were randomly assigned to receive either T2DM health information only (Intervention package1 [IP1]) or IP1 plus a subsidized meal with vegetables and fruits, following the principles of the HPM (Intervention package2 [IP2]). Within the clusters the participants were informed on the importance of the intervention they received. An intervention period lasted for three months from 1st April to 31st June 2019. We applied Generalized Linear Mixed Models and Bayesian Modelling (for sensitivity analysis) to assess the effectiveness of the interventions.

RESULTS: Overall, 336 (IP2 = 175 and IP1 = 161) out of 560 (280/arm) previous study participants participated in evaluation. Diastolic BP was lower among IP2 participants in the evaluation than baseline AβC = -4.1mmHg (95%CI:-5.42 to -2.76). After adjusting for the interaction between IP2 and age of the consumers, the BMI was significantly lower among IP2 in the evaluation than baseline AβC = -0.7kg/m2 (95%CI: -1.17 to -0.23). With interaction between IP2 and income, BMI was higher in the IP2 in the evaluation than baseline AβC = 0.73kg/m2 (95%CI: 0.08 to 1.38). Systolic and diastolic BP were significantly lower among IP1 in the evaluation than baseline AβC = -3.5mmHg (95%CI:-5.78 to -1.24) and AβC = -5.9mmHg (95%CI:-7.34 to -4.44) respectively. Both the knowledge scores and positive attitudes towards T2DM prevention measures were higher in the evaluation than baseline in both interventions arms.

CONCLUSION: The positive effects on cardio-metabolic risk factors, knowledge and attitude were observed in both intervention arms. Due to interactions between IP2, age and income; designing interventions relating to food and cardio-metabolic risk factors, should consider combining socio-economic factors.

PMID:37967111 | DOI:10.1371/journal.pone.0289289

PLoS One. 2023 Nov 15;18(11):e0291394. doi: 10.1371/journal.pone.0291394. eCollection 2023.

ABSTRACT

BACKGROUND: Homebirth preference is the intention/plan to give birth outside health facilities with the help of unskilled birth attendants. The preference to give birth at home without a skilled birth attendant leads to care-seeking delays, intrapartum mortality, multiple stillbirths, and postpartum morbidities and mortality. Therefore, this study aimed to estimate the pooled prevalence of homebirth preference and associated factors among pregnant women in Ethiopia.

METHODS: Search of Google Scholar, Medline, PubMed, Cochrane Library and Web of Science were done for this study from 20th August 2022 to 6th November 2022. For data extraction and analysis, the standardized data extraction checklist and Stata version 14 were used respectively. Sentence as “Cochrane Q test statistics and I2 statistics were used to check heterogeneity of the studies. The pooled prevalence of homebirth preference was estimated using a random-effects model. The association between homebirth preference and independent variables was determined using an odd ratio with a 95% confidence interval. A funnel plot and Egger’s test were used to assess publication bias.

RESULTS: A total of 976 research articles were identified. Seven studies that fulfilled eligibility criteria were included in this systematic review and meta-analysis. The pooled prevalence of homebirth preference in Ethiopia was 39.62% (95% CI 27.98, 51.26). The current meta-analysis revealed that average monthly income <1800 ETB (OR = 2.66, 95% CI 1.44, 4.90) lack of ANC follow-up (OR = 2.57, 95%CI 1.32, 5.01), being multipara (OR = 1.77, 95%CI 1.39, 2.25), poor knowledge about obstetric danger sign (OR = 5.75, 95%CI 1.o2, 32.42), and not discussing the place of delivery with a partner (OR = 5.89 (95%CI 1.1, 31.63) were significantly associated with homebirth preference.

CONCLUSION: This systematic review and meta-analysis examined the substantial prevalence of homebirth preference in Ethiopia which may contribute maternal and child health crisis. The homebirth preference was associated with low average monthly income (<1800 ETB), lack of ANC follow-up, multipara, poor knowledge about obstetric danger signs, and not discussing with their partner the place of delivery. Improving knowledge of pregnant women about the benefit of health facility delivery and obstetric danger signs is necessary to decrease the prevalence of homebirth preference; for these can reduce negative outcomes occurred during delivery.

PMID:37967092 | DOI:10.1371/journal.pone.0291394

PLoS One. 2023 Nov 15;18(11):e0294339. doi: 10.1371/journal.pone.0294339. eCollection 2023.

ABSTRACT

OBJECTIVE: Transcultural adaptation and validation of FACIT-TS-PS questionnaire to Serbian language.

METHODS: Standard forward and backward translation from English to Serbian language was performed. Pilot testing of FACIT-TS-PS was conducted on 12 patients with a confirmed diagnosis of malignant tumor. The study included 154 patients with malignant disease. The Questionnaire of Patient Satisfaction was used as a validated tool to evaluate concurrent validity of FACIT-TS-PS questionnaire. Reproducibility was tested on 30 subjects who answered the questionnaire for the second time two weeks later.

RESULTS: Three FACIT-TS-PS subscales (Physician Communication, Treatment Staff Communication and Nurse Communication) demonstrated satisfactory construct validity using Cronbach’s alpha, the remaining two subscales (Technical Competence and Confidence & Trust) showed high ceiling effect. Treatment Staff Communication subscale showed large floor effect. Concurrent validity was demonstrated by correlation with the two dimensions of the Questionnaire of Patient Satisfaction. Satisfactory reproducibility was demonstrated on 30 patients who filled the questionnaire for the second time two weeks after initial interview.

CONCLUSION: The Serbian version of FACIT-TS-PS with the omission of Treatment Staff Communication subscale could be used as a valid instrument to assess patient and treatment satisfaction in chronically ill patients in the Serbian population. Omission of Treatment Staff Communication subscale is necessary because it contains questions not relevant for patients in Serbian healthcare system.

PMID:37967091 | DOI:10.1371/journal.pone.0294339

PLoS One. 2023 Nov 15;18(11):e0292783. doi: 10.1371/journal.pone.0292783. eCollection 2023.

ABSTRACT

BACKGROUND & OBJECTIVES: No definite treatment is known for COVID-19 till date. The objective of this study is to assess the efficacy of customized Homoeopathic medicines, when used as an add-on treatment to Standard of Care (SOC), in patients suffering from moderate to severe COVID-19 infection.

METHODS: This was a randomized, controlled, single-blind, parallel-group trial where 214 COVID19-positive patients were screened for moderate and severe cases of COVID-19. Adjuvant homoeopathic medicines were given in the treatment group and SOC was given to both groups. The duration of oxygen support was compared as the primary outcome. Subjects were followed for 28 days or till the end-point of mechanical ventilation/ death.

RESULTS: Of 129 subjects included, 57 and 55 were severe; and 8 and 9 were moderate cases in Homoeopathy and SOC arms, respectively. In all, 9 (15.2%) participants in Homoeopathy and 20 (32.2%) participants in SOC arms eventually expired (p<0.05). Oxygen support was required for 9.84±7.00 and 14.92±7.549 days in Homoeopathy and SOC arms, respectively (p<0.005). Subjects receiving Homoeopathy (12.9±6.days) had a shorter hospitalization stay than in SOC (14.9±7.5 days). Homoeopathy arm (10.6±5.7 days) also showed statistically significant mean conversion time of of Realtime-Polymerase Chain Reaction (RT-PCR) from positive to negative than the SOC arm (12.9±5.6 days). The mean score of Clinical Outcome Ordinal Scale (COOS) was lower in the Homoeopathy arm. Laboratory markers [Interleukins (IL)-6, C-reactive protein (CRP), Neutrophils-Lymphocytes ratio (NLR)]were normalized earlier in Homoeopathy arm.

CONCLUSION: Homoeopathy, as add-on therapy with SOC for COVID-19 management, demonstrates a reduction in mortality and morbidity, by reduced requirement of oxygen and hospitalization. Some laboratory markers are normalized at an earlier time. Hence, there is overall control over the disease. Registry: The study was registered on the http://ctri.nic.in/Clinicaltrials website under identifier number: CTRI/2020/12/029668 on 9th December 2020.

PMID:37967089 | DOI:10.1371/journal.pone.0292783

PLOS Glob Public Health. 2023 Nov 15;3(11):e0002543. doi: 10.1371/journal.pgph.0002543. eCollection 2023.

ABSTRACT

Livestock are important reservoirs for many zoonotic diseases, however the effects of livestock on human and environmental health extend well beyond direct disease transmission. In this retrospective ecological cohort study we use pre-existing data and the parametric g-formula, which imputes potential outcomes to quantify mediation, to estimate three hypothesized mechanisms by which livestock can influence human African trypanosomiasis (HAT) risk: the reservoir effect, where infected cattle and pigs are a source of infection to humans; the zooprophylactic effect, where preference for livestock hosts exhibited by the tsetse fly vector of HAT means that their presence protects humans from infection; and the environmental change effect, where livestock keeping activities modify the environment in such a way that habitat suitability for tsetse flies, and in turn human infection risk, is reduced. We conducted this study in four high burden countries: at the point level in Uganda, Malawi, and Democratic Republic of Congo (DRC), and at the county level in South Sudan. Our results indicate cattle and pigs play a reservoir role for the rhodesiense form (rHAT) in Uganda (rate ratio (RR) 1.68, 95% CI 0.84, 2.82 for cattle; RR 2.16, 95% CI 1.18, 3.05 for pigs), however zooprophylaxis outweighs this effect for rHAT in Malawi (RR 0.85, 95% CI 0.68, 1.00 for cattle, RR 0.38, 95% CI 0.21, 0.69 for pigs). For the gambiense form (gHAT) we found evidence that pigs may be a competent reservoir (RR 1.15, 95% CI 0.92, 1.72 in Uganda; RR 1.25, 95% CI 1.11, 1.42 in DRC). Statistical significance was reached for rHAT in Malawi (pigs and cattle) and Uganda (pigs only) and for gHAT in DRC (pigs and cattle). We did not find compelling evidence of an environmental change effect (all effect sizes close to 1).

PMID:37967087 | DOI:10.1371/journal.pgph.0002543

JMIR Form Res. 2023 Nov 15;7:e50870. doi: 10.2196/50870.

ABSTRACT

BACKGROUND: Frailty, a common geriatric syndrome, predisposes older adults to functional decline. No medications can alter frailty’s trajectory, but nutritional interventions may aid in supporting independence.

OBJECTIVE: This paper presents a pilot randomized controlled trial to investigate the feasibility and efficacy of a mobile health intervention, “Olitor,” designed to enhance adherence to the Mediterranean diet among older adults with frailty, requiring no external assistance.

METHODS: The study sample consisted of 15 participants aged 66-77 (mean 70.5, SD 3.96) years randomized into intervention (n=8; 8 females; mean 72.4, SD 4.8 years) and control groups (n=7; 6 females, 1 male; mean 70.0, SD 3.9 years). The intervention involved a patient-facing mobile app called “Olitor” and a secure web-based administrative dashboard. Participants were instructed to use the app at least weekly for 3 months, which provided feedback on their food choices, personalized recipe recommendations, and an in-app messaging feature. Using Mann-Whitney tests to compare change scores and Hedges g statistics to estimate effect sizes, the primary efficacy outcomes were adherence to the Mediterranean diet score and insulin resistance measures. Secondary outcomes included retention as a measure of feasibility, engagement level and user app quality ratings for acceptability, and additional metrics to evaluate efficacy. Models were adjusted for multiple comparisons.

RESULTS: The findings demonstrated a significant improvement in the Mediterranean diet adherence score in the intervention group compared to the control (W=50.5; adjusted P=.04) with median change scores of 2 (IQR 2-4.25) and 0 (IQR -0.50 to 0.50), respectively. There was a small and insignificant reduction in homeostasis model assessment of insulin resistance measure (W=23; adjusted P=.85). Additionally, there were significant increases in legume intake (W=54; adjusted P<.01). The intervention’s effect size was large for several outcomes, such as Mediterranean diet adherence (Hedges g=1.58; 95% CI 0.34-2.67) and vegetable intake (Hedges g=1.14; 95% CI 0.08-2.21). The retention rate was 100%. The app’s overall quality rating was favorable with an average interaction time of 12 minutes weekly.

CONCLUSIONS: This pilot study revealed the potential of the mobile intervention “Olitor” in promoting healthier eating habits among older adults with frailty. It demonstrated high retention rates, significant improvement in adherence to the Mediterranean diet, and increased intake of recommended foods. Insulin resistance showed a minor nonsignificant improvement. Several secondary outcomes, such as lower extremity function and Mediterranean diet knowledge, had a large effect size. Although the app’s behavior change features were similar to those of previous digital interventions, the distinctive focus on theory-informed mechanistic measures involved in behavioral change, such as self-regulation, self-efficacy, and expected negative outcomes, may have enhanced its potential. Further investigations in a more diverse and representative population, focusing on individuals with impaired insulin sensitivity, are warranted to validate these preliminary findings.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05236712; https://clinicaltrials.gov/study/NCT05236712.

PMID:37966877 | DOI:10.2196/50870

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