Category: Statistics

Eur J Med Res. 2023 Oct 21;28(1):452. doi: 10.1186/s40001-023-01440-9.

ABSTRACT

OBJECTIVE: This study compared remimazolam tosylate with propofol or midazolam to assess its safety and effectiveness for long-term sedation of intensive care unit (ICU) patients requiring mechanical ventilation.

METHODS: Adult patients in the ICU receiving sedation and mechanical ventilation for longer than 24 h were included in this single-center, prospective, observational study. Depending on the sedatives they were given, they were split into two groups (midazolam or propofol group; remimazolam group). ICU mortality was the main result. Laboratory tests, adverse events, and the length of ICU stay were considered secondary outcomes.

RESULTS: A total of 106 patients were involved (46 received propofol or midazolam versus 60 received remimazolam). Age (P = 0.182), gender (P = 0.325), and the amount of time between being admitted to the ICU and receiving medication infusion (P = 0.770) did not substantially differ between the two groups. Multivariate analysis revealed no statistically significant difference in ICU mortality between the two groups. The remimazolam group showed less variability in heart rate (P = 0.0021), pH (P = 0.048), bicarbonate (P = 0.0133), lactate (P = 0.0002), arterial blood gas analyses, liver, and kidney function. The Richmond Agitation and Sedation Scale scores, length of ICU stay, and occurrence of adverse events did not exhibit significant differences between the two groups.

CONCLUSION: Remimazolam tosylate did not increase the total inpatient cost, the incidence of adverse events, and ICU mortality in patients with mechanical ventilation. These findings suggest that remimazolam may represent a promising alternative for sedation in the ICU setting.

PMID:37865799 | DOI:10.1186/s40001-023-01440-9

Stem Cell Res Ther. 2023 Oct 21;14(1):303. doi: 10.1186/s13287-023-03534-x.

ABSTRACT

BACKGROUND: There is growing interest to application of regenerative medicine approaches in otorhinolaryngological practice, especially in the framework of the therapy of vocal fold (VF) scar lesions. The used conservative and surgical methods, despite the achieved positive outcomes, are frequently unpredictable and do not result in the restoration of the VF’s lamina propria’s structure, which provides the mechanical properties necessary for vibration. In this connection, the aim of this study was to ascertain the safety and efficacy of a bioequivalent in the treatment of VF scars using a rabbit model of chronic damage.

METHODS: The bioequivalent consisted of a hydrogel system based on a PEG-fibrin conjugate and human bone marrow-derived MSC. It was characterized and implanted heterotopically into rats and orthotopically into rabbits after VF scar excision.

RESULTS: We showed that the fabricated bioequivalent consisted of viable cells retaining their metabolic and proliferative activity. While being implanted heterotopically, it had induced the low inflammatory reaction in 7 days and was well tolerated. The orthotopic implantation showed that the gel application was characterized by a lower hemorrhage intensity (p = 0.03945). The intensity of stridor and respiratory rate between the groups in total and between separate groups had no statistically significant difference (p = 0.96 and p = 1; p = 0.9593 and p = 0.97…1, respectively). In 3 days post-implantation, MSC were detected only in the tissues closely surrounding the VF defect. The bioequivalent injection caused that the scar collagen fibers were packed looser and more frequently mutually parallel that is inherent in the native tissue (p = 0.018). In all experimental groups, the fibrous tissue’s ingrowth in the adjacent exterior muscle tissue was observed; however, in Group 4 (PEG-Fibrin + MSC), it was much less pronounced than it was in Group 1 (normal saline) (p = 0.008). The difference between the thicknesses of the lamina propria in the control group and in Group 4 was not revealed to be statistically significant (p = 0.995). The Young’s modulus of the VF after the bioequivalent implantation (1.15 ± 0.25 kPa) did not statistically significantly differ from the intact VF modulus (1.17 ± 0.45 kPa); therefore, the tissue properties in this group more closely resembled the intact VF.

CONCLUSIONS: The developed bioequivalent showed to be biocompatible and highly efficient in the restoration of VF’s tissue.

PMID:37865795 | DOI:10.1186/s13287-023-03534-x

Malar J. 2023 Oct 21;22(1):320. doi: 10.1186/s12936-023-04757-2.

ABSTRACT

BACKGROUND: Malaria infection during pregnancy is an important cause of maternal and infant mortality and morbidity with the greatest effect being concentrated in sub-Saharan Africa. In areas of moderate to high malaria transmission, the World Health Organization (WHO) recommends the administration of intermittent preventive treatment of malaria in pregnancy (IPTp) using sulfadoxine-pyrimethamine (SP) to be given to all pregnant women at each scheduled antenatal care visit at monthly intervals. However, there is concern that increased resistance has compromised its effectiveness. This has led to a need for evaluation of alternatives to SP for IPTp with dihydroartemisinin-piperaquine (DP) emerging as a very promising candidate. Thus, this systematic review and aggregated data meta-analysis was conducted to establish the safety and tolerability of repeated doses with DP in IPTp.

METHODS: A systematic review and aggregated data meta-analysis of randomized controlled trials (RCTs) was performed by searching electronic databases of PubMed, Science Direct, ClinicalTrials.gov and Google Scholar. RCTs comparing IPTp DP versus recommended standard treatment for IPTp with these outcome measures were analyzed; change in QTc interval, serious adverse events (SAE), grade 3 or 4 adverse events possibly related to study drug and vomiting within 30 min after study drug administration. The search was performed up to 24th June 2023. Data was extracted from eligible studies and an aggregated data meta-analysis was carried out with data pooled as risk ratio (RR) with a 95% confidence interval (CI), using RevMan software (5.4). This study is registered with PROSPERO, CRD42022310041.

RESULTS: Six RCTs involving 7969 participants were included in this systematic review and aggregated data meta-analysis. The pooled analysis showed that DP was associated with a change from baseline of the QTc interval although this change was not associated with cardiotoxicity. There was no statistically significant difference in the risk of occurrence of SAEs among participants in both treatment groups (RR = 0.80, 95% CI [0.52-1.24], P = 0.32). However, significant difference was observed in grade 3 or 4 AEs possibly related to study drug where analysis showed that subjects on IPT DP were statistically significantly more likely to experience an AE possibly related to study drug than subjects on IPT SP (RR = 6.65, 95% CI [1.18-37.54], P = 0.03) and in vomiting within 30 min after study drug administration where analysis showed that the risk of vomiting is statistically significantly higher in subjects receiving IPT DP than in subjects receiving IPT SP (RR = 1.77, 95% CI [1.02-3.07], P = 0.04).

CONCLUSION: DP was associated with a higher risk of grade 3 or 4 AEs possibly related to study drug and a higher risk of vomiting within 30 min after study drug administration. However, these were experienced in a very small percentage of women and did not affect adherence to study drugs. DP was also better tolerated in these studies as compared to most alternatives that have been proposed to replace SP which have proved to be too poorly tolerated in IPTp use.

PMID:37865784 | DOI:10.1186/s12936-023-04757-2

BMC Womens Health. 2023 Oct 21;23(1):544. doi: 10.1186/s12905-023-02709-1.

ABSTRACT

BACKGROUND: Papua New Guinea (PNG) has recorded the highest maternal mortality ratio in the Western Pacific Region and faces major challenges in achieving SDG 3. Antenatal care (ANC), skilled birth attendant (SBA) and postnatal care (PNC) services are critical components of maternal healthcare services (MHS) for reducing maternal mortality and promoting maternal health in PNG. The study sought to assess the prevalence and determinants of ANC, SBA and PNC services amongst women in PNG.

METHODS: The study was conducted using the 2016-2018 Papua New Guinea Demographic and Health Survey. A total of 5248 reproductive-age women were considered as the analytical sample. The outcome variables were utilisation of ANC, SBA and PNC services. Chi-square test, multivariable logistic regression and dominance analysis were conducted. Statistical significance was set at p < 0.05.

RESULTS: The prevalence rates of ANC, SBA and PNC services were 52.3%, 58.7% and 26.6%, respectively. Women’s employment, education, media exposure, distance to health facility, household wealth, region, residence and parity were determinants of MHS utilisation. ANC, SBA and PNC services utilisation were all primarily influenced by enabling factors, followed by predisposing and need factors.

CONCLUSIONS: This study demonstrated that enabling factors such as media exposure, distance to health facility, household wealth, region and residence have the greatest impact on MHS utilisation, followed by predisposing (working, education) and need factors (parity). Therefore, enabling factors should be prioritised when developing maternal health programmes and policies. For example, transport and health infrastructure should be strengthened and women’s education and vocational training should be increased, especially in Highlands region, Momase region and rural areas, to increase the utilisation of MHS.

PMID:37865780 | DOI:10.1186/s12905-023-02709-1

BMC Neurol. 2023 Oct 21;23(1):381. doi: 10.1186/s12883-023-03413-1.

ABSTRACT

BACKGROUND: Despite advancements in acute stroke care, acute stroke patients present late for care resulting in high mortality and poor functional outcomes. This study determined the prevalence of pre-hospital delay and associated factors among adult acute stroke patients in Uganda.

METHODS: In a hospital based, cross-sectional study, one hundred and forty-three study participants with confirmed acute stroke presenting to the emergency units of Mulago and Kiruddu national referral hospitals were enrolled. Using an interviewer-administered questionnaire, details on sociodemographics, onset of stroke, arrival at the tertiary facility, health system and clinical factors were collected. Descriptive statistics and modified Poisson regression analyses were performed to determine factors associated with prehospital delay.

RESULTS: Among the 143 study participants, nearly two-thirds (79/146) had ischemic stroke while a third (59/143) had haemorrhagic stroke. The mean age was 59 years (SD 16) and 51.7% of acute stroke patients were males. Ninety one percent (130/143) presented to the emergency unit after 3 hours. The majority (124/143) reported visiting lower-level facilities prior to referral to the tertiary facility. Staying outside Kampala district (PR: 1.28 (1.22-1.34), p < 0.001), and using hired or government ambulance for transport to tertiary facility (PR: 1.17 (1.13-1.20), p < 0.001) were associated with pre-hospital delay.

CONCLUSIONS: Prevalence of pre-hospital delay among acute stroke patients presenting to public tertiary hospitals in Uganda is very high. The causes of pre hospital delay should be further explored qualitatively. Efforts to reduce prehospital delay should include improving pre-hospital transport systems for stroke patients.

PMID:37865778 | DOI:10.1186/s12883-023-03413-1

BMC Cardiovasc Disord. 2023 Oct 21;23(1):514. doi: 10.1186/s12872-023-03543-x.

ABSTRACT

BACKGROUND: Cardiometabolic multimorbidity (CMM) and obesity represent two major health problems. The relationship between adiposity indices and CMM, however, remains understudied. This study aimed to investigate the associations of body mass index (BMI), waist circumference (WC), waist-to-height ratio (WHtR), a body shape index (ABSI), body roundness index (BRI), and conicity index (CI) with CMM among Chinese adults.

METHODS: Data of 101,973 participants were collected from a population-based screening project in Southern China. CMM was defined as having two or more of the following diseases: coronary heart disease, stroke, hypertension, and diabetes. The relationship between the six adiposity indices and CMM was investigated by multivariate logistic regression and restricted cubic splines. Receiver operator characteristic curve, C-statistic and net reclassification index were used to estimate the discriminative and incremental values of adiposity indices on CMM.

RESULTS: Logistic regression models showed the six adiposity indices were all significantly associated with the odds of CMM with non-linear relationships. For per SD increment, WC (Odds ratio [OR]: 1.66; 95% confidence interval (CI): 1.62-1.70) and WHtR (OR, 1.61; 95% CI, 1.58-1.65) were more significantly associated with a higher prevalence of CMM than BMI (OR, 1.55; 95% CI, 1.52-1.58) (all P < 0.05). In addition, WC, WHtR, and BRI displayed significantly better performance in detecting CMM compared with BMI (all P < 0.05). Their respective area under the curve (AUC) values were 0.675 (95% CI: 0.670-0.680), 0.679 (95% CI: 0.675-0.684), and 0.679 (95% CI: 0.675-0.684), while BMI yielded an AUC of 0.637 (95% CI: 0.632-0.643). These findings hold true across all subgroups based on sex and age. When Adding WC, WHtR, or BRI to a base model, they all provided larger incremental values for the discrimination of CMM compared with BMI (all P < 0.05).

CONCLUSIONS: Adiposity indices were closely associated with the odds of CMM, with WC and WHtR demonstrating stronger associations than BMI. WC, WHtR, and BRI were superior to BMI in discriminative ability for CMM. Avoidance of obesity (especially abdominal obesity) may be the preferred primary prevention strategy for CMM while controlling for other major CMM risk factors.

PMID:37865773 | DOI:10.1186/s12872-023-03543-x

Lipids Health Dis. 2023 Oct 21;22(1):180. doi: 10.1186/s12944-023-01946-5.

ABSTRACT

BACKGROUND: The impact of total cholesterol (TC) on lumbar bone mineral density (BMD) is a topic of interest. However, empirical evidence on this association from demographic surveys conducted in China is lacking. Therefore, this study aimed to examine the relationship between serum TC and lumbar BMD in a sample of 20,544 Chinese adults between the ages of 20 and 80 years over a period of 5 years, from February 2018 to February 2023. Thus, we investigated the effect of serum TC level on lumbar BMD and its relationship with bone reduction in a Chinese adult population.

METHODS: This cross-sectional study used data obtained from the Department of Health Management at Henan Provincial People’s Hospital between February 2018 and February 2023. The aim of this study was to examine the correlation between serum TC and lumbar BMD in individuals of different sexes. The research methodology encompassed population description, analysis of stratification, single-factor and multiple-equation regression analyses, smooth curve fitting, and analysis of threshold and saturation effects. The R and EmpowerStats software packages were used for statistical analysis.

RESULTS: After adjusting for confounding variables, a multiple linear regression model revealed a significant correlation between TC and lumbar BMD in men. In subgroup analysis, serum TC was found to have a positive association with lumbar BMD in men, specifically those aged 45 years or older, with a body mass index (BMI) ranging from 24 to 28 kg/m². A U-shaped correlation arose between serum TC and lumbar BMD was detected in women of different ages and BMI, the inflection point was 4.27 mmol/L for women aged ≥ 45 years and 4.35 mmol/L for women with a BMI of ≥ 28 kg/m².

CONCLUSION: In this study, Chinese adults aged 20-80 years displayed different effects of serum TC on lumbar BMD in sex-specific populations. Therefore, monitoring BMI and serum TC levels in women of different ages could prevent osteoporosis and osteopenia.

TRIAL REGISTRATION: The research protocol was approved by the Ethics Committee of Beijing Jishuitan Hospital, in accordance with the Declaration of Helsinki guidelines (No. 2015-12-02). These data are part of the China Health Quantitative CT Big Data Research team, which has been registered at clinicaltrials.gov (code: NCT03699228).

PMID:37865752 | DOI:10.1186/s12944-023-01946-5

BMC Med Res Methodol. 2023 Oct 21;23(1):245. doi: 10.1186/s12874-023-02064-7.

ABSTRACT

BACKGROUND: Systematic reviews of randomized controlled trials are the best evidence for informing on intervention effectiveness. Their results, however, can be biased due to omitted evidence in the quantitative analyses. We aimed to assess the proportion of randomized controlled trials omitted from meta-analyses in the rehabilitation field and explore related reasons.

METHODS: This is a cross-sectional meta-research study. For each systematic review included in a published selected sample in the rehabilitation field, we identified an index meta-analysis on the primary outcome and the main comparison. We then looked at all the studies considered eligible for the chosen comparison in the systematic review and identified those trials that have been omitted (i.e., not included) from each index meta-analysis. Reasons for omission were collected based on an eight-reason classification. We used descriptive statistics to describe the proportion of omitted trials overall and according to each reason.

RESULTS: Starting from a cohort of 827 systematic reviews, 131 index meta-analyses comprising a total of 1761 eligible trials were selected. Only 16 index meta-analyses included all eligible studies while 15 omitted studies without providing references. From the remaining 100 index meta-analyses, 717 trials (40,7%) were omitted overall. Specific reasons for omission were: “unable to distinguish between selective reporting and inadequate planning” (39,3%, N = 282), “inadequate planning” (17%, N = 122), “justified to be not included” (15,1%, N = 108), “incomplete reporting” (8,4%, N = 60), “selective reporting” (3,3%, N = 24) and other situations (e.g., outcome present but no motivation for omission) (5,2%, N = 37). The 11,7% (N = 84) of omitted trials were not assessed due to non-English language or full text not available.

CONCLUSIONS: Almost half of the eligible trials were omitted from their index meta-analyses. Better reporting, protocol registration, definition and adoption of core outcome sets are needed to prevent omission of evidence in systematic reviews.

PMID:37865743 | DOI:10.1186/s12874-023-02064-7

BMC Pediatr. 2023 Oct 21;23(1):524. doi: 10.1186/s12887-023-04340-3.

ABSTRACT

BACKGROUND: A specific eHealth device, a surf tablet, was developed for bridging between advanced in-hospital care and children’s homes. Since little is known about determinators for parental eHealth usage, the study’s aim was to explore if parents’ usage of the device was associated with their eHealth literacy, or their satisfaction with their child’s healthcare or with the specific surf tablet.

METHODS: In this explorative usage and questionnaire study, parents to neonates who were discharged home after advanced in-hospital care were included. Their surf tablet usage at maximum 30 days after discharge was reported as frequency (%) of active days (usage days/days having the device) and median number of tablet activities (chat and photo) per usage day. eHealth literacy (eHealth Literacy Questionnaire; eHLQ), healthcare satisfaction (PedsQL Healthcare Satisfaction Generic Module), and satisfaction with the surf tablet were explored regarding tablet usage. Statistics were described in median (range) and (%) using non-parametric and regression models (p < 0.05).

RESULTS: Parents to 32 children (11 premature, 21 operated) were included. Active days with eHealth communication using the device was 39% (9.0/29.5), with 2.0 (1.0-4.2) usage occasions per active day. Activity on the tablet was higher among parents reporting to be very satisfied or satisfied with the device (n = 25) compared with neutral/dissatisfied parents (n = 7) (2.8 vs. 2.2 vs. 1.6 activities) (p = 0.030), while their frequency of active days did not differ (31.6% vs. 38.3% vs. 40%) (p = 0.963). A higher eHealth literacy was not associated with frequency of active days (0.926 (0.652-1.317); p = 0.659) or number of eHealth activities (0.973 (0.758-1.250); p = 0.825). Healthcare satisfaction was not associated with higher frequency of active days 0.996 (0.983-1.009; p = 0.519); neither was number of eHealth activities 1.001 (0.991-1.011; p = 0.883).

CONCLUSION: In this study, eHealth usage was associated with parental satisfaction with the specific eHealth device, but not with eHealth literacy or healthcare satisfaction. To assure equal access to healthcare when using eHealth, the user-friendliness of the device seems to be crucial, and technical support needs to be in place.

GOV REGISTRATION IDENTIFIER: NCT04150120 (04/11/2019).

PMID:37865736 | DOI:10.1186/s12887-023-04340-3

BMC Complement Med Ther. 2023 Oct 21;23(1):372. doi: 10.1186/s12906-023-04180-9.

ABSTRACT

BACKGROUND: Respiratory diseases (RD) can challenge healthcare systems around the globe. Natural health products (NHPs) are popular complementary and alternative medicine options for health issues concerning non-fatal RD. Little is known about the characteristics of the users of RD-NHPs and about their NHP consumption behavior during the Covid-19 pandemic in Germany.

METHODS: A representative online survey was conducted in Germany in 2022. 1707 participants were classified based on having used NHPs for RD within the previous 12 months, having used NHPs but not for RD within the previous 12 months and not having used NHPs. Data were analyzed using descriptive and inferential statistical methods as well as a multinomial logistic regression model.

RESULTS: Users of RD-NHPs within the previous 12 months were more likely to be employed and to consult pharmacists more often for non-fatal health issues than individuals who did not take RD-NHPs. RD-NHP users were more likely to suffer from a Covid-19 infection and to have children living in the same household than other NHP users. Compared to non-NHP users, RD-NHP users were more likely to be female, highly educated and have stronger openness-to-change value orientations. Vaccination-related behavior was no indicator of RD-NHP usage. Most RD-NHP users took NHPs in self-medication. Few reported informing their practitioner about their self-medication. Drugstores were the most visited supply source for NHPs during the pandemic, followed by pharmacies. Common information sources regarding NHPs were the products themselves and pharmacists.

CONCLUSION: This study emphasized the important role of NHPs as a popular prevention and treatment option for RD. RD-NHPs were more likely used by individuals who were employed, who suffered from a RD and who consult pharmacists for non-fatal health issues. The importance of product information and pharmacies as information sources should be considered to make communication strategies about safe self-medication options with RD-NHPs more effective, which could help to reduce the burden of health facilities regarding non-fatal RD. To improve and develop future pandemic-control strategies, health professionals and policy makers should consider NHP usage behavior and provide critical information about chances and risks of self-medicated NHP consumption.

PMID:37865731 | DOI:10.1186/s12906-023-04180-9