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Lack of impact of ipragliflozin on endothelial function in patients with type 2 diabetes: sub-analysis of the PROTECT study

Cardiovasc Diabetol. 2023 May 20;22(1):119. doi: 10.1186/s12933-023-01856-x.

ABSTRACT

BACKGROUND: We assessed the impact of 24 months of treatment with ipragliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on endothelial function in patients with type 2 diabetes as a sub-analysis of the PROTECT study.

METHODS: In the PROTECT study, patients were randomized to receive either standard antihyperglycemic treatment (control group, n = 241 ) or add-on ipragliflozin treatment (ipragliflozin group, n = 241) in a 1:1 ratio. Among the 482 patients in the PROTECT study, flow-mediated vasodilation (FMD) was assessed in 32 patients in the control group and 26 patients in the ipragliflozin group before and after 24 months of treatment.

RESULTS: HbA1c levels significantly decreased after 24 months of treatment compared to the baseline value in the ipragliflozin group, but not in the control group. However, there was no significant difference between the changes in HbA1c levels in the two groups (7.4 ± 0.8% vs. 7.0 ± 0.9% in the ipragliflozin group and 7.4 ± 0.7% vs. 7.3 ± 0.7% in the control group; P = 0.08). There was no significant difference between FMD values at baseline and after 24 months in both groups (5.2 ± 2.6% vs. 5.2 ± 2.6%, P = 0.98 in the ipragliflozin group; 5.4 ± 2.9% vs. 5.0 ± 3.2%, P = 0.34 in the control group). There was no significant difference in the estimated percentage change in FMD between the two groups (P = 0.77).

CONCLUSIONS: Over a 24-month period, the addition of ipragliflozin to standard therapy in patients with type 2 diabetes did not change endothelial function assessed by FMD in the brachial artery.

TRIAL REGISTRATION: Registration Number for Clinical Trial: jRCT1071220089 ( https://jrct.niph.go.jp/en-latest-detail/jRCT1071220089 ).

PMID:37210524 | DOI:10.1186/s12933-023-01856-x

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The impact of PTSD on risk of cardiometabolic diseases: a national patient cohort study in Norway

BMC Psychiatry. 2023 May 20;23(1):349. doi: 10.1186/s12888-023-04866-x.

ABSTRACT

BACKGROUND: Posttraumatic stress disorder (PTSD) is associated with cardiometabolic diseases, concurrent anxiety, alcohol use disorder and depression. The relationship between PTSD and cardiometabolic diseases are still unclear, and less is known about the effects of socioeconomic status, comorbid anxiety, comorbid alcohol use disorder and comorbid depression. The study, therefore, aims to examine the risk of developing cardiometabolic diseases including type 2 diabetes mellitus over time in PTSD patients, and to what extent socioeconomic status, comorbid anxiety, comorbid alcohol use disorder and comorbid depression attenuate associations between PTSD and risk of developing cardiometabolic diseases.

METHOD: A retrospective, register-based cohort study with 6-years follow-up of adult (> 18 years) PTSD patients (N = 7 852) compared with the general population (N = 4 041 366), was performed. Data were acquired from the Norwegian Patient Registry and Statistic Norway. Cox proportional regression models were applied to estimate hazard ratios (HRs) (99% confidence intervals) of cardiometabolic diseases among PTSD patients.

RESULTS: Significantly (p < 0.001) higher age and gender adjusted HRs were disclosed for all cardiometabolic diseases among PTSD patients compared to the population without PTSD, with a variation in HR from 3.5 (99% CI 3.1-3.9) for hypertensive diseases to HR = 6.5 (5.7-7.5) for obesity. When adjusted for socioeconomic status and comorbid mental disorders, reductions were observed, especially for comorbid depression, for which the adjustment resulted in HR reduction of about 48.6% for hypertensive diseases and 67.7% for obesity.

CONCLUSIONS: PTSD was associated with increased risk of developing cardiometabolic diseases, though attenuated by socioeconomic status and comorbid mental disorders. Health care professionals should be attentive towards the burden and increased risk that low socioeconomic status and comorbid mental disorders may represent for PTSD patients’ cardiometabolic health.

PMID:37210523 | DOI:10.1186/s12888-023-04866-x

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Improving access to early intervention for autism: findings from a proof-of-principle cascaded task-sharing naturalistic developmental behavioural intervention in South Africa

Child Adolesc Psychiatry Ment Health. 2023 May 20;17(1):64. doi: 10.1186/s13034-023-00611-0.

ABSTRACT

BACKGROUND: Despite the high number of children living with neurodevelopmental disabilities in sub-Saharan Africa, access to early intervention is almost non-existent. It is therefore important to develop feasible, scalable early autism intervention that can be integrated into systems of care. While Naturalistic Developmental Behavioural Intervention (NDBI) has emerged as an evidence-based intervention approach, implementation gaps exist globally, and task-sharing approaches may address access gaps. In this South African proof-of-principle pilot study, we set out to answer two questions about a 12-session cascaded task-sharing NDBI-whether the approach could be delivered with fidelity, and whether we could identify signals of change in child and caregiver outcomes.

METHODS: We utilized a single-arm pre-post design. Fidelity (non-specialists, caregivers), caregiver outcomes (stress, sense of competence), and child outcomes (developmental, adaptive) were measured at baseline (T1) and follow-up (T2). Ten caregiver-child dyads and four non-specialists participated. Pre-to-post summary statistics were presented alongside individual trajectories. Non-parametric Wilcoxon signed rank test for paired samples was used to compare group medians between T1 and T2.

RESULTS: Caregiver implementation fidelity increased in 10/10 participants. Non-specialists demonstrated a significant increase in coaching fidelity (increases in 7/10 dyads). Significant gains were seen on two Griffiths-III subscales (Language/Communication-9/10 improved, Foundations of Learning-10/10 improved) and on the General Developmental Quotient (9/10 improved). Significant gains were also seen on two Vineland Adaptive Behaviour Scales (Third Edition) subscales (Communication-9/10 improved, Socialization-6/10 improved) and in the Adaptive Behaviour Standard Score (9/10 improved). Caregiver sense of competence improved in 7/10 caregivers and caregiver stress in 6/10 caregivers.

CONCLUSIONS: This proof-of-principle pilot study of the first cascaded task-sharing NDBI in Sub-Saharan Africa provided fidelity and intervention outcome data which supported the potential of such approaches in low-resource contexts. Larger studies are needed to expand on the evidence-base and answer questions on intervention effectiveness and implementation outcomes.

PMID:37210513 | DOI:10.1186/s13034-023-00611-0

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Association of chorioamnionitis with infertility treatment and subsequent neonatal outcomes in the US: a population-based cohort study

BMC Pregnancy Childbirth. 2023 May 20;23(1):369. doi: 10.1186/s12884-023-05619-0.

ABSTRACT

BACKGROUND: Chorioamnionitis (CAM) is a common risk factor for preterm births, resulting in several adverse outcomes. The association between infertility treatment and CAM is unclear. Therefore, this study examined the association between infertility treatment and CAM and described subsequent neonatal outcomes.

METHODS: This population-based cohort study used data from the National Vital Statistics System Database. We included women who had a singleton live birth from January 1, 2016 to December 31, 2018. Women-infant pairs were stratified by infertility treatment, and the main outcome was a reported diagnosis of CAM in a checkbox format: clinical CAM or maternal temperature of > 38 °C. Multivariate logistic regression was used to examine the association between infertility treatment and CAM and the effect of infertility treatment on neonatal outcomes in women diagnosed with CAM.

RESULTS: The final sample comprised 10,900,495 woman-infant pairs, and 1.4% received infertility treatment. Compared with the natural conception group, women receiving infertility treatment had a significantly higher risk of CAM (adjusted odds ratio [aOR] 1.772 [95% confidence interval {CI}, 1.718-1.827]). Furthermore, newborns exposed to CAM had a higher risk of very low birth weight (VLBW) (aOR, 2.083 [95% CI, 1.664-2.606], P < .001), preterm birth (aOR, 1.497 [95% CI, 1.324-1.693]; P < .001), neonatal intensive care unit admission (aOR, 1.234 [95% CI, 1.156-1.317]; P < .001), and other adverse neonatal outcomes in the infertility treatment group compared with ones conceived naturally.

CONCLUSIONS: This study found that women who received infertility treatment had a higher risk of CAM. And CAM deteriorated neonatal outcomes in the infertility treatment group.

PMID:37210503 | DOI:10.1186/s12884-023-05619-0

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The knock-on effects of COVID-19 pandemic on the supply and availability of generic medicines in Ethiopia: mixed methods study

BMC Health Serv Res. 2023 May 20;23(1):513. doi: 10.1186/s12913-023-09535-z.

ABSTRACT

BACKGROUND: COVID-19 pandemic posed a major impact on the availability and affordability of essential medicines. This study aimed to assess the knock-on effects of the COVID-19 pandemic on the supply availability of non-communicable chronic disease (NCD) medicines and paracetamol products in Ethiopia.

METHODS: A mixed methods study was conducted to assess the supply and availability of twenty-four NCD drugs and four paracetamol products listed on the national essential medicines list for hospitals. Data were collected from twenty-six hospitals located in seven zones of Oromia region in the southwestern part of Ethiopia. We extracted data on drug availability, cost and stock out for these drugs between May 2019 and December 2020. The quantitative data were entered into Microsoft Excel and exported to statistical package software for social science (SPSS) version 22 (IBM Corporation, Armonk, NY, USA) software for analysis.

RESULTS: The overall mean availability of selected basket medicines was 63.4% (range 16.7% to 80.3%) during the pre-COVID-19 time. It was 46.3% (range 2.8% to 88.7) during the pandemic. There was a relative increase in the availability of two paracetamol products [paracetamol 500 mg tablet (67.5% versus 88.7%) and suppository (74.5% versus 88%)] during the pandemic. The average monthly orders fill rates for the selected products range from 43 to 85%. Pre-COVID-19, the average order fill rate was greater or equal to 70%. However, immediately after the COVID-19 case notification, the percentage of order(s) filled correctly in items and quantities began decreasing. Political instability, shortage of trained human resources, currency inflation, and limited drug financing were considered as the major challenges to medicine supply.

CONCLUSION: The overall stock out situation in the study area has worsened during COVID-19 compared to pre-COVID-19 time. None of the surveyed chronic disease basket medicines met the ideal availability benchmark of 80% in health facilities. However, availability of paracetamol 500 mg tablet surprisingly improved during the pandemic. A range of policy frameworks and options targeting inevitable outbreaks should exist to enable governments to ensure that medicines for chronic diseases are consistently available and affordable.

PMID:37210502 | DOI:10.1186/s12913-023-09535-z

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Improved access to HIV diagnosis and linkage to antiretroviral therapy among children in Southern Nigeria: a before-after study

BMC Pediatr. 2023 May 20;23(1):253. doi: 10.1186/s12887-023-04050-w.

ABSTRACT

BACKGROUND: Globally, two out of five children living with HIV (CLHIV) are unaware of their HIV status, and a little more than 50% are receiving antiretroviral therapy (ART). This paper describes case-finding strategies and their contribution to identifying CLHIV and linking them to ART in Nigeria.

METHODS: This before-after study used program data abstracted during the implementation of different paediatric-focused strategies (provider-initiated testing and counselling, orphans and vulnerable children testing, family-based index testing, early infant diagnosis (EID), community-driven EID, and community-based testing) delivered in health facilities and in communities to improve HIV case identification. Data were abstracted for children (0 to 14 years) who received HIV testing services and were initiated on ART in Akwa Ibom State, Nigeria during the pre-implementation period (April-June 2021) and during the implementation period (July-September 2021). Descriptive statistics were used to describe the testing coverage, positivity rate (proportion of tests that were positive for HIV), linkage to ART, and ART coverage, by age, sex, and testing modality. Interrupted time series analysis (ITSA) on STATA 14 was used to estimate the effect of the implementation of these strategies on HIV testing uptake and positivity rate at a 0.05 significance level.

RESULTS: A total of 70,210 children were tested for HIV within the six-month period, and 1,012 CLHIV were identified. A total of 78% (n = 54,821) of the tests and 83.4% (n = 844) CLHIV were diagnosed during the implementation period. During implementation, the HIV positivity rate increased from 1.09% (168/15,389) to 1.54% (844/54,821), while linkage to ART increased from 99.4% (167/168) to 99.8% (842/844). The contribution from community-based modalities to CLHIV identified increased from 63% (106/168) to 84% (709/844) during the implementation, with the majority, 60.8% (431/709), from community-based index testing. Overall, ART coverage increased from 39.7 to 55.6% at the end of the intervention period.

CONCLUSION: The findings show that expanding differentiated HIV testing approaches provided mostly in the community significantly increased pediatric case identification. However, ART coverage remains low, especially for younger age groups, and requires further efforts.

PMID:37210497 | DOI:10.1186/s12887-023-04050-w

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Knowledge, attitude, and uptake of human papillomavirus vaccine among adolescent schoolgirls in Ethiopia: a systematic review and meta-analysis

BMC Womens Health. 2023 May 20;23(1):279. doi: 10.1186/s12905-023-02412-1.

ABSTRACT

BACKGROUND: Cervical cancer is an international public health issue. Nearly all cases of cervical cancer are caused by the human papillomavirus. The HPV vaccine prevents more than 75% of cervical cancer. The extent to which adolescent girls’ knowledge and uptake of the HPV vaccine have to be investigated in order to build effective promotion strategies and increase the uptake of the vaccine. The evidence that is currently available in this area is controversial and inconclusive. Hence, this study has estimated the pooled proportion of good knowledge, positive attitude, and uptake of the HPV vaccine and its associated factors among adolescent schoolgirls in Ethiopia.

METHODS: PubMed, Google Scholar, AJOL, ScienceDirect, and DOAJ were used to search relevant studies. A total of 10 studies were included. The data were extracted by two reviewers using Microsoft Excel and exported to STATA Version 17 for analysis. A random effects model was applied during the analysis. Heterogeneity and publication bias across the studies were evaluated using I2 statistics and Egger’s test, respectively. The PROSPERO registration number for the review is CRD42023414030.

RESULT: A total of eight studies comprising 3936 study participants for knowledge and attitude and five studies with 2,481 study participants for uptake of HPV were used to estimate the pooled proportions of good knowledge, a positive attitude, and uptake of the HPV vaccine, respectively. The pooled proportions of good knowledge, positive attitude, and uptake of the HPV vaccine were 55.12%, 45.34%, and 42.05%, respectively. Being an urban resident (OR = 4.17, 95% CI = 1.81, 9.58), having good knowledge (OR = 6.70, 95% CI = 3.43, 13.07), and a positive attitude (OR = 2.04, 95% CI = 1.51, 2.74), were significantly associated with the uptake of the vaccine.

CONCLUSION: The pooled proportions of good knowledge, a positive attitude, and uptake of the HPV vaccine were low in Ethiopia. Being an urban resident and having good knowledge and a positive attitude towards the HPV vaccine were significantly associated with the uptake of the HPV vaccine. We recommend increasing adolescent knowledge, positive attitudes, and uptake of HPV vaccination through school-based seminars, health education, and community mobilization.

PMID:37210492 | DOI:10.1186/s12905-023-02412-1

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A systematic review and meta-analysis of complications of artificial urinary sphincters in female patients with urinary incontinence due to internal sphincter insufficiency

BMC Urol. 2023 May 20;23(1):97. doi: 10.1186/s12894-023-01274-x.

ABSTRACT

BACKGROUND: Urinary incontinence (UI) is a common worldwide rising health issue among women with a prevalence of 5 to 70%. Stress urinary incontinence (SUI) is the most common subtype of UI. There are different treatments for UI, including AUS (artificial urinary sphincter) implantation, as one of the surgical options for treating SUI. The aim of this study was to determine the complication rate of AUS, exclusively in female patients with SUI, which resulted from ISD (intrinsic sphincter deficiency). We also compared the complication rate between minimally invasive (laparoscopic or robotic surgery) and open approaches.

METHODS: Scopus, PubMed, Web of Science, Embase, and Google Scholar were searched for studies regarding complications in AUS implantation surgery, from the beginning of the project to March 2022. After screening and reviewing of full text, the general characteristics of the study and study population including follow-up time, type of surgery, and the number of complications that occurred such as necrosis, atrophy, erosion, infection, mechanical failure, revision, and leak, were extracted.

RESULTS: We found that atrophy occurred in 1 of 188 (0.53%) patients treated with minimally invasive surgery and in 1 of 669 (0.15%) patients treated with open surgery. None of the 17 included studies reported the occurrence of necrosis in the patients under study. Erosion occurred in 9 of 188 (4.78%) patients treated with minimally invasive surgery and in 41 of 669 (6.12%) patients treated with open surgery. Infection occurred in 12 of 188 (6.38%) patients treated with minimally invasive surgery and in 22 of 669 (3.2%) patients treated with open surgery. The mechanical failure occurred in 1 of 188 (0.53%) patients treated with minimally invasive surgery and in 55 of 669 (8.22%) patients treated with open surgery. Reconstructive surgery occurred in 7 of 188 (3.72%) patients treated with minimally invasive surgery and in 95 of 669 (14.2%) patients treated with open surgery. Leaks occurred in 4 of 188 (2.12%) patients treated with minimally invasive surgery and in 6 of 669 (0.89%) patients treated with open surgery. The type of surgery was associated with a statistically significant increase in mechanical failure (p-value = 0.067) and infection (p-value = 0.021), and reconstructive surgery (p-value = 0.049). Out of the 857 participats in the study,469 were studied for less than five years and 388 were studied for more than five years.21 of 469 (4.4%) (p-value = 0.08) patients and 81 of 388 (20.8%) (p-value = 0.001) patients required reconstructive surgery. Erosion occurred in 23 of 469 (4.9%) (p-value = 0.01)patients with following time less than five years and in 27 of 388 (6.9%) (p-value = 0.001) patients with following time more than five years.

CONCLUSION: The use of artificial urinary sphincters in the treatment of UI causes complications such as atrophy, erosion, and infection; the amount of which is influenced by the surgical method and the duration of using the artificial urinary sphincter. It seems that the use of new surgical methods, such as laparoscopic surgery, is useful in reducing the incidence of complications.

PMID:37210489 | DOI:10.1186/s12894-023-01274-x

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Postoperative effect of sufentanil preemptive analgesia combined with psychological intervention on breast cancer patients

BMC Anesthesiol. 2023 May 20;23(1):170. doi: 10.1186/s12871-023-02143-8.

ABSTRACT

OBJECTIVES: To explore the postoperative effects of sufentanil preemptive analgesia combined with psychological intervention on breast cancer patients undergoing radical surgery.

METHODS: 112 female breast cancer patients aged 18-80 years old who underwent radical surgery by the same surgeon were randomly divided into 4 groups, and there were 28 patients in each group. Patients in group A were given 10 µg sufentanil preemptive analgesia combined with perioperative psychological support therapy (PPST), group B had only 10 µg sufentanil preemptive analgesia, group C had only PPST, and group D were under general anesthesia with conventional intubation. Visual analogue scoring (VAS) was used for analgesic evaluation at 2, 12 and 24 h after surgery and compared among the four groups by ANOVA method.

RESULTS: The awakening time of patients in group A or B was significantly shorter than that in group C or D, and the awakening time in group C was significantly shorter than that in group D. Moreover, patients in group A had the shortest extubation time, while the group D had the longest extubation time. The VAS scores at different time points showed significant difference, and the VAS scores at 12 and 24 h were significantly lower than those at 2 h (P < 0.05). The VAS scores and the changing trend of VAS scores were varied among the four groups (P < 0.05). In addition, we also found that patients in group A had the longest time to use the first pain medication after surgery, while patients in group D had the shortest time. But the adverse reactions among the four groups showed no difference.

CONCLUSIONS: Sufentanil preemptive analgesia combined with psychological intervention can effectively relieve the postoperative pain of breast cancer patients.

PMID:37210488 | DOI:10.1186/s12871-023-02143-8

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Correction: The association of rod curvature with postoperative outcomes in patients undergoing posterior lumbar interbody fusion for spinal stenosis: a retrospective case-control study

BMC Musculoskelet Disord. 2023 May 20;24(1):403. doi: 10.1186/s12891-023-06532-5.

NO ABSTRACT

PMID:37210487 | DOI:10.1186/s12891-023-06532-5