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Variability in recurrence rates with acute treatments for migraine: why recurrence is not an appropriate outcome measure

J Headache Pain. 2022 Nov 22;23(1):148. doi: 10.1186/s10194-022-01519-4.

ABSTRACT

BACKGROUND: Headache recurrence is a common feature of acute therapies, whether approved or still in development, and continues to be a significant problem for both the patient and the clinician. Further complicating this issue is lack of standardization in definitions of recurrence used in clinical trials, as well as disparity in patient characteristics, rendering a comparison of different acute medications challenging. Recurrence has serious clinical implications, which can include an increased risk for new-onset chronic migraine and/or development of medication overuse headache. The aim of this review is to illustrate variability of recurrence rates depending on prevailing definitions in the literature for widely used acute treatments for migraine and to emphasize sustained response as a clinically relevant endpoint for measuring prolonged efficacy. BODY: A literature search of PubMed for articles of approved acute therapies for migraine that reported recurrence rates was performed. Study drugs of interest included select triptans, gepants, lasmiditan, and dihydroergotamine mesylate. An unpublished post hoc analysis of an investigational dihydroergotamine mesylate product that evaluated recurrence rates using several different definitions of recurrence common in the literature is also included. Depending on the criteria established by the clinical trial and the definition of recurrence used, rates of recurrence vary considerably across different acute therapies for migraine, making it difficult to compare results of different trials to assess the sustained (i.e., over a single attack) and the prolonged (i.e., over multiple attacks) efficacy of a particular study medication.

CONCLUSION: A standardized definition of recurrence is necessary to help physicians evaluate recurrence rates of different abortive agents for migraine. Sustained pain relief or freedom may be more comprehensive efficacy outcome measures than recurrence. Future efficacy studies should be encouraged to use the recommended definition of sustained pain freedom set by the International Headache Society.

PMID:36414952 | DOI:10.1186/s10194-022-01519-4

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Prevalence and factors associated with the use of long-acting reversible and permanent contraceptive methods among women who desire no more children in high fertility countries in sub-saharan Africa

BMC Public Health. 2022 Nov 21;22(1):2141. doi: 10.1186/s12889-022-14575-x.

ABSTRACT

BACKGROUND: The proportion of women with family planning needs increased from 74 to 76% between 2000 and 2019, and this improvement has not transcended to a fertility rate stall or decrease in sub-Saharan Africa (SSA). In the face of a continuous increase in the fertility rate in SSA, population experts agreed that the efficient use of reliable family planning methods such as long-acting reversible and permanent contraceptive methods (LARC/PMs) could help reduce the high fertility rate and associated adverse reproductive health outcomes in the region. However, despite the effectiveness of LARC/PMs, its use remains elusive in SSA. Thus, this study examines the prevalence and factors associated with the use of LARC/PMs among women who desire no more children in high-fertility countries in SSA.

METHODS: Secondary datasets from the demographic health surveys conducted in 20 countries in SSA between 2010 and 2019 were included in the study. A total sample size of 46,290 sexually active women of reproductive age who desire no more children and who met the study inclusion criteria was pooled and analysed. Prevalence of LARC/PMs use was displayed using a graph whilst binary logistic regression was used to determine the associated factors, and results were presented as unadjusted odds ratio and adjusted odds ratio with a statistical significance of p < 0.05.

RESULTS: The prevalence of LARC/PMs use among women who desire no more children was 7.5%. Ranging from 20.9% in Senegal and as low as 0.4% in Congo. Women within the richest wealth index [aOR = 1.18, 95% CI = 1.03-1.36] and those exposed to mass media [aOR = 1.54, 95% CI = 1.41-1.68] had higher odds of LARC/PMs use among sexually active women of reproductive age who desire no more children compared to those within poorest wealth index and women with no mass media exposure.

CONCLUSION: The study concluded that LARC/PMs use among sexually active women who desire no more children was very low, and women within the richest wealth index and those with mass media exposure were likely to use LARC/PMs. Interventions that will encourage using LARC/PMs should be prioritised to reduce fertility rates in SSA.

PMID:36414944 | DOI:10.1186/s12889-022-14575-x

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Bedaquiline safety, efficacy, utilization and emergence of resistance following treatment of multidrug-resistant tuberculosis patients in South Africa: a retrospective cohort analysis

BMC Infect Dis. 2022 Nov 21;22(1):870. doi: 10.1186/s12879-022-07861-x.

ABSTRACT

BACKGROUND: This retrospective cohort study assessed benefits and risks of bedaquiline treatment in multidrug-resistant-tuberculosis (MDR-TB) combination therapy by evaluating safety, effectiveness, drug utilization and emergence of resistance to bedaquiline.

METHODS: Data were extracted from a register of South African drug-resistant-tuberculosis (DR-TB) patients (Electronic DR-TB Register [EDRWeb]) for newly diagnosed patients with MDR-TB (including pre-extensively drug-resistant [XDR]-TB and XDR-TB and excluding rifampicin-mono-resistant [RR]-TB, as these patients are by definition not multidrug-resistant), receiving either a bedaquiline-containing or non-bedaquiline-containing regimen, at 14 sites in South Africa. Total duration of treatment and follow-up was up to 30 months, including 6 months’ bedaquiline treatment. WHO treatment outcomes within 6 months after end-of-treatment were assessed in both patient groups. Longer term mortality (up to 30 months from treatment start) was evaluated through matching to the South African National Vital Statistics Register. Multivariable Cox proportional hazards analyses were used to predict association between receiving a bedaquiline-containing regimen and treatment outcome.

RESULTS: Data were extracted from EDRWeb for 5981 MDR-TB patients (N = 3747 bedaquiline-treated; N = 2234 non-bedaquiline-treated) who initiated treatment between 2015 and 2017, of whom 40.7% versus 80.6% had MDR-TB. More bedaquiline-treated than non-bedaquiline-treated patients had pre-XDR-TB (27.7% versus 9.5%) and XDR-TB (31.5% versus 9.9%) per pre-2021 WHO definitions. Most patients with treatment duration data (94.3%) received bedaquiline for 6 months. Treatment success (per pre-2021 WHO definitions) was achieved in 66.9% of bedaquiline-treated and 49.4% of non-bedaquiline-treated patients. Death was reported in fewer bedaquiline-treated (15.4%) than non-bedaquiline-treated (25.6%) patients. Bedaquiline-treated patients had increased likelihood of treatment success and decreased risk of mortality versus non-bedaquiline-treated patients. In patients with evaluable drug susceptibility testing data, 3.5% of bedaquiline-susceptible isolates at baseline acquired phenotypic resistance. Few patients reported bedaquiline-related treatment-emergent adverse events (TEAEs) (1.8%), TEAE-related bedaquiline discontinuations (1.4%) and QTcF values > 500 ms (2.5%) during treatment.

CONCLUSION: Data from this large cohort of South African patients with MDR-TB showed treatment with bedaquiline-containing regimens was associated with survival and effectiveness benefit compared with non-bedaquiline-containing regimens. No new safety signals were detected. These data are consistent with the positive risk-benefit profile of bedaquiline and warrant continued implementation in combination therapy for MDR-TB treatment.

PMID:36414938 | DOI:10.1186/s12879-022-07861-x

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Assessment of groundwater geochemistry for drinking and irrigation suitability in Jaunpur district of Uttar Pradesh using GIS-based statistical inference

Environ Sci Pollut Res Int. 2022 Nov 22. doi: 10.1007/s11356-022-23959-w. Online ahead of print.

ABSTRACT

The quality of groundwater in the Jaunpur district of Uttar Pradesh is poorly studied despite the fact that it is the only supply of water for both drinking and irrigation and people use it without any pre-treatment. The evaluation of groundwater quality and suitability for drinking and irrigation is presented in this study. Groundwater samples were collected and analysed by standard neutralisation and atomic emission spectrophotometry for major anions (HCO3, SO42-, Cl, F, NO3), cations (Ca2+, Mg2+, Na+, K+), and heavy metals (Cd, Mn, Zn, Cu, and Pb). The geographic information system (GIS) and statistical inferences were utilised for the spatial mapping of the groundwater’s parameters. The potential water abstraction (i.e. taking water from sources such as rivers, streams, canals, and underground) for irrigation was assessed using the sodium absorption ratio (SAR), permeability index (PI), residual sodium carbonate (RSC), and Na percentage. According to the findings, the majority of the samples had higher EC, TDS, and TH levels, indicating that they should be avoided for drinking and irrigation. The positive correlation coefficient between chemical variability shows that the water chemistry of the studied region is influenced by geochemical and biological causes. According to the USSL (United States Salinity Laboratory) diagram, most of the samples fall under the C2-S1 and C3-S1 moderate to high salt categories. Some groundwater samples were classified as C4-S3 class which is unfit for irrigation and drinking. This study suggests that the groundwater in the study area is unfit for drinking without treatment. However, the majority of the samples were suitable for irrigation.

PMID:36414896 | DOI:10.1007/s11356-022-23959-w

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Percutaneus intermetatarsal ligament release and minimally invasive distal metatarsal osteotomy for treatment second intermetatarsal space syndrome

Eur J Orthop Surg Traumatol. 2022 Nov 21. doi: 10.1007/s00590-022-03442-5. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Since the description of the syndrome of the second intermetatarsal space, this is a common diagnosis among foot and ankle surgeons. However, no series have been published that consider this syndrome as its own entity. The objective of this study is to evaluate the clinical and radiological results of the release of the intermetatarsal ligament and minimally invasive distal metatarsal osteotomy in patients diagnosed with second space syndrome.

MATERIALS AND METHODS: An observational, longitudinal, retrospective study was carried out in patients with a clinical diagnosis of second space syndrome operated on using a minimally invasive technique. For the clinical results, the visual analog scale (VAS) for subjective pain, the Manchester-Oxford Foot Questionnaire (MOXFQ) and the scale for minor metatarsals and interphalangeals of the American Orthopedic Foot and Ankle Society (AOFAS-LMTS) were used for clinical-functional assessment. Consolidation or not of osteotomies was recorded and complications were recorded.

RESULTS: Twenty-nine feet in 29 patients were included in the study. After a mean follow-up of 39 months (25-50), clinically and statistically significant improvement was obtained in the scores: pain VAS, scales and subscales of the MOXFQ and the AOFAS-LMTS (p < 0.0001). All osteotomies healed at the end of follow-up and no major complications were recorded.

CONCLUSIONS: Percutaneous or minimally invasive surgery, in patients with second intermetatarsal space syndrome, obtains good clinical, functional and subjective results, with few complications. Therefore, we consider it an effective, safe and recommended technique in the hands of experienced surgeons.

PMID:36414873 | DOI:10.1007/s00590-022-03442-5

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Author Correction: AGREE-S: AGREE II extension for surgical interventions: appraisal instrument

Surg Endosc. 2022 Nov 22. doi: 10.1007/s00464-022-09770-1. Online ahead of print.

NO ABSTRACT

PMID:36414872 | DOI:10.1007/s00464-022-09770-1

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Physicians’ perceptions about antineutrophil cytoplasmic antibody-associated vasculitis: an online survey report in the time of the COVID-19 pandemic

Clin Rheumatol. 2022 Nov 21. doi: 10.1007/s10067-022-06452-0. Online ahead of print.

ABSTRACT

Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) are characterized by necrotizing inflammation of small and medium-size vessels that often manifest with devastating multi-organ effects. They present with a myriad of systemic features and require potent immunosuppression. Since they are uncommonly encountered in clinical practice, it is necessary to understand physicians’ knowledge and perceptions about this group of diseases. An online questionnaire was designed featuring 28 questions based on relevant global practice guidelines, recommendations, and previous online surveys on AAV. The questionnaire was validated by a core group of specialists with an interest in AAV. It was shared via social networking sites and entries were restricted to physicians. Only completed entries were analyzed with descriptive statistics. A total of 113 respondents from 21 different countries responded of whom the commonest were rheumatologists, internists, and general practitioners. Forty-five (40%) ran clinics dedicated to AAV patients as a part of their practice. They commented on organs involved in AAV; vasculitis secondary to infections, drugs or other rheumatic diseases; various tests useful for AAV diagnosis; and drug choices for induction and maintenance. They mentioned their experience regarding COVID-19 in AAV patients as well as vasculitic manifestations of COVID-19. Various methods to mitigate cardiovascular risks in AAV were mentioned. Finally, the respondents indicated how medical education needed to be strengthened to increase awareness and knowledge regarding AAV. This survey helped to inform about various perceptions regarding AAV across countries, including current practices and recent evolution of management. It also provided information on treatment of the COVID-19 in AAV patients. This survey showed that there is still a lack in understanding the prevalent definitions and there is gap between guidelines and current practice. Key Points • Perception about ANCA-associated vasculitis differ across countries. • The number of cases encountered across 21 different countries are limited implying a need for multi-national cooperation to study this disease further. • The COVID-19 pandemic has changed the approach towards ANCA-associated vasculitis by the various clinicians.

PMID:36414862 | DOI:10.1007/s10067-022-06452-0

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Analysis of the outer retinal thickness pixel maps for the screening of hydroxychloroquine retinopathy

Int Ophthalmol. 2022 Nov 21. doi: 10.1007/s10792-022-02573-2. Online ahead of print.

ABSTRACT

PURPOSE: To describe the findings and new interpretation methods of retinal thickness maps in the setting of hydroxychloroquine (HCQ) therapy.

METHODS: A case series of 27 patients with a history of HCQ intake of more than 5 years and 21 normal subjects as the control group were studied. Patients were tested using swept-source optical coherence tomography (OCT). Custom-made 10 × 10 retinal thickness pixel maps of the 6 mm⨯6 mm area centered on the fovea were created for the full, inner, and outer retina of each eye and normal values obtained from the control group were used to calculate the statistical significance of each pixel and highlight suspicious pixels. A pixel was shown with light or dark gray color if its p value was ≤ 0.05 or ≤ 0.01, respectively. Cross-sectional OCT images and visual fields were examined as well and used to confirm the diagnosis of HCQ retinopathy.

RESULTS: The pixel outer retinal thickness maps appeared accurate in detecting lesions even in eyes with unremarkable full retina thickness maps. The size and location of atrophic retinal defects were shown on pixel maps. Outer retinal thickness maps were able in differentiating outer retinal thinning from inner retinal thinning as the hallmark of HCQ retinopathy.

CONCLUSION: Outer retinal thickness pixel maps can be used for the screening of HCQ retinopathy.

PMID:36414851 | DOI:10.1007/s10792-022-02573-2

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The Effectiveness of Granulocyte Colony-Stimulating Factor (G-CSF) Against Experimental Ischemia-Reperfusion Injury in Rat Ovaries and Its Effect on In Vitro Fertilization Outcomes

Reprod Sci. 2022 Nov 22. doi: 10.1007/s43032-022-01132-5. Online ahead of print.

ABSTRACT

Local ischemic damage resulting from ovarian torsion is a common cause of decreased follicular activity and infertility. It was aimed to evaluate the effect of granulocyte colony-stimulating factor (G-CSF) protection on in vitro fertilization (IVF) results against experimental ischemic (I) and ischemic-reperfusion (I/R) injury in rat ovaries. The study consisted of 35 adult female Sprague-Dawley albino rats (sham, ischemia, I/R, I + G-CSF, and I/R + G-CSF) randomly assigned to 5 groups, each containing 7 rats. While bilateral adnexal torsion was applied to the ischemia groups for 3 h, detorsion was applied to the reperfusion groups. Intraperitoneal 100 IU/kg G-CSF was administered 30 min prior to ischemia (I + G-CSF) or reperfusion (I/R + G-CSF). After ovulation induction (intraperitoneal 150-300 IU/kg PMSG), the oocytes were collected and IVF was applied. Statistically significant differences were observed between the collected oocyte numbers in I and I + G-CSF, I/R, and I/R + G-CSF groups (P values were P = 0.001 for the I-I + G-SCF groups and P = 0.003 for I/R-IR + G-CSF, respectively). An increase in the number of MII oocytes obtained was observed in the I + G-CSF and I/R + G-CSF groups compared to the I and I/R groups. Grade 1 and grade 2 embryo numbers were statically different between the I/R and I/R + G-CSF groups (P values were P = 0.023 for grade 1 embryos and P = 0.045 for grade 2 embryos, respectively). G-CSF treatment was found to be effective in reducing I- and I/R-induced ovarian damage.

PMID:36414821 | DOI:10.1007/s43032-022-01132-5

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An integrated model of UTAUT2 to understand consumers’ 5G technology acceptance using SEM-ANN approach

Sci Rep. 2022 Nov 21;12(1):20056. doi: 10.1038/s41598-022-24532-8.

ABSTRACT

It has been a decade since the first extensive study on the internet’s adoption and use was conducted. Circumstances have changed in the last decade internet has become an essential need for every human being. Socio-psychological, economic, and personal factors play a significant role in shaping human behaviour. But their role in shaping consumer behaviour toward 5G is still unexplored. In order to determine the impact of socio-psychological elements on 5G technology adoption intention, the study integrated curiosity, perceived value, functional value, and environmental awareness into UTAUT2 and analyzed how they interact. Instead of relying on linear models, this study employed a dual-stage SEM-ANN approach because customers’ decision-making process to adopt new technology is complex. Valid responses from 840 respondents were collected, investigated, and ranked using the deep learning ANN approach. All predictors were found statistically significant except social influence. ANN sensitivity analysis revealed that newly integrated predictors (environmental awareness, curiosity) are surprisingly the most important predictors, followed by facilitating conditions and perceived satisfaction. SEM-ANN hybrid two-step deep learning approach explained 83.6% variance higher than the baseline model (UTAUT2). The study improved UTAUT2 by adding new variables and expanding its canvas to predict user technology adoption. This will show how consumers react to 5G services and help telecoms grow into new markets.

PMID:36414788 | DOI:10.1038/s41598-022-24532-8