Category: Statistics

BMC Oral Health. 2021 May 8;21(1):247. doi: 10.1186/s12903-021-01572-6.

ABSTRACT

BACKGROUND: Implant-supported overdentures offer enhanced mechanical properties, which lead to better patient satisfaction and survival rates than conventional dentures. However, it is unclear whether these satisfaction levels and survival rates depend on the number of implants supporting the overdenture. Therefore, this systematic review aimed to compare maxillary overdentures supported by four or six splinted implants in terms of patient satisfaction, implant survival, overdenture survival, and prosthodontic complications.

METHODS: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), and EMBASE databases were systematically searched and complemented by hand searching from 2000 to 2019, employing a combination of specific keywords. Studies comparing the use of four versus six implants for supporting overdentures with at least one-year of follow-up after prosthesis installation and including ten fully edentulous patients were included. The risk of bias (RoB) was analyzed with Cochrane’s RoB 2 and Newcastle-Ottawa tools. Implants and prosthesis survival rates were analyzed by random-effects meta-analysis and expressed as risk ratios or risk differences, respectively, and by the non-parametric unpaired Fisher’s test.

RESULTS: A total of 15 from 1865 articles were included, and reported follow-up times after implant placement ranged from 1 to 10 years. Irrespective of the number of implants used, high scores were reported by all studies investigating patient satisfaction. Meta-analysis and non-parametric Fisher’s test showed no statistical differences regarding the survival rate of implants (P = 0.34, P = 0.3) or overdentures (P = 0.74, P = 0.9) when using 4 versus 6 splinted implants to support overdentures, and no significant differences regarding prosthodontic complications were found between groups. Randomized studies presented high RoB and non-randomized studies presented acceptable quality.

CONCLUSIONS: Within the limits of this systematic review, we can conclude that the bar-supported overdenture on four implants is not inferior to the overdenture supported by six implants for rehabilitating the edentulous maxilla, in terms of patient satisfaction, survival rates of implants and overdentures, and prosthodontic complications.

PMID:33962612 | DOI:10.1186/s12903-021-01572-6

Cardiovasc Diabetol. 2021 May 7;20(1):102. doi: 10.1186/s12933-021-01290-x.

ABSTRACT

BACKGROUND: Women with type 2 diabetes are disproportionally affected by macrovascular complications; we here investigated whether this is also the case for microvascular complications and retinal microvascular measures.

METHODS: In a population-based cohort study of individuals aged 40-75 years (n = 3410; 49% women, 29% type 2 diabetes (oversampled by design)), we estimated sex-specific associations, and differences therein, of (pre)diabetes (reference: normal glucose metabolism), and of continuous measures of glycemia with microvascular complications and retinal measures (nephropathy, sensory neuropathy, and retinal arteriolar and venular diameters and dilatation). Sex differences were analyzed using regression models with interaction terms (i.e. sex-by- (pre)diabetes and sex-by-glycemia) and were adjusted for potential confounders.

RESULTS: Men with type 2 diabetes (but not those with prediabetes) compared to men with normal glucose metabolism, (and men with higher levels of glycemia), had significantly higher prevalences of nephropathy (odds ratio: 1.58 95% CI (1.01;2.46)) and sensory neuropathy (odds ratio: 2.46 (1.67;3.63)), larger retinal arteriolar diameters (difference: 4.29 µm (1.22;7.36)) and less retinal arteriolar dilatation (difference: – 0.74% (- 1.22; – 0.25)). In women, these associations were numerically in the same direction, but generally not statistically significant (odds ratios: 1.71 (0.90;3.25) and 1.22 (0.75;1.98); differences: 0.29 µm (- 3.50;4.07) and: – 0.52% (- 1.11;0.08), respectively). Interaction analyses revealed no consistent pattern of sex differences in the associations of either prediabetes or type 2 diabetes or glycemia with microvascular complications or retinal measures. The prevalence of advanced-stage complications was too low for evaluation.

CONCLUSIONS: Our findings show that women with type 2 diabetes are not disproportionately affected by early microvascular complications.

PMID:33962619 | DOI:10.1186/s12933-021-01290-x

BMC Ophthalmol. 2021 May 8;21(1):202. doi: 10.1186/s12886-021-01959-7.

ABSTRACT

BACKGROUND: To determine the preoperative factors influencing refractive astigmatism after cataract surgery for astigmatism correction by toric intraocular lens (IOL) implantation and to evaluate the prediction model using these factors.

METHODS: Prospective, observational case series. The right eyes of forty consecutive patients with preoperative corneal astigmatism of the total cornea of 1.5 diopters (D) or more in magnitude and scheduled for implantation of a non-toric IOL during cataract surgery with a 2.4-mm temporal clear corneal incision were examined prospectively. The vertical/horizontal astigmatism component (J0) and oblique astigmatism component (J45) of refractive and corneal astigmatism were converted using power vector analysis. Multivariate regression analysis was performed with refractive astigmatism at three months postoperatively as the dependent variable, and preoperative parameters including age, sex, refractive astigmatism, corneal astigmatism, sphere, spherical equivalent, intraocular pressure, corneal thickness, anterior chamber depth, lens thickness, lens positions (tilt and decentration), axial length, and corneal higher order aberrations as independent variables. The root mean square (RMS) errors were calculated to express the regression model fit.

RESULTS: The regression model for the J0 component was [Formula: see text] (R² = 0.96, P < 0.001). The model for the J45 component was [Formula: see text] (R² = 0.72, P < 0.001). The mean RMS errors for preoperative corneal astigmatism alone and the multivariate model were 0.58 D and 0.46 D, respectively. There was a statistically significant difference between them (P = 0.02).

CONCLUSIONS: Refractive astigmatism after implantation of a toric IOL can be predicted by the regression model more accurately than by corneal astigmatism alone. However, the prediction of oblique astigmatism remains a challenge.

PMID:33962598 | DOI:10.1186/s12886-021-01959-7

BMC Health Serv Res. 2021 May 7;21(1):437. doi: 10.1186/s12913-021-06422-3.

ABSTRACT

BACKGROUND: The significant contribution of community-based distribution (CBD) of family planning services and contraceptives to the uptake of contraceptives in hard-to-reach communities has resulted in the scaling-up of this approach in many Sub-Saharan countries. However, contextual factors need to be taken into consideration. For example, social network influence (e.g. spouse/partner, in-laws, and parents) on fertility decisions in many African and Asian societies is inevitable because of the social organisational structures. Hence the need to adapt CBD strategies to the social network context of a given society.

METHODS: Data collection involved structured interviews from August 2018 to March 2019. Randomly selected respondents (n = 149) were recruited from four purposively selected health facilities in Lusaka district, Zambia. Respondents were screened for age (> 15 yrs.) and marital status. A mix of categorical and qualitative data was generated. The Statistical Package for Social Sciences (SPSS®²⁴) was used to carry out descriptive analysis and tests of association (Fisher’s exact) while Nvivo®¹² was used to analyse the qualitative data using a deductive thematic approach.

RESULTS: The results indicate that pre-marriage counselling (pre-MC) influences key elements of the husband-wife relationship (p > 0.005), namely; sexual relationship, inter-personal communication, assignation of roles and responsibilities, leadership and authority. These elements of the husband-wife relationship also affect how spouses/partners interact when making fertility decisions. More importantly, the majority (86%) of the respondents indicated having a continuing relationship with their marriage counsellors because of the need to consult them on marital issues.

CONCLUSION: Marriage counsellors, though hardly reported in fertility studies, are important ‘constituents’ of the social network in the Zambian society. This is because marriage counsellors are trusted sources of information about marital issues and often consulted about family planning but perceived not to have the correct information about modern contraceptives. In this context, pre-MC offers a readily available, sustainable and culturally appropriate platform for disseminating accurate information about modern contraceptives provided in a private and personal manner. Therefore, the CBD strategy in Zambia can harness marriage counsellors by recruiting and training them as community agents.

PMID:33962591 | DOI:10.1186/s12913-021-06422-3

BMC Cancer. 2021 May 7;21(1):514. doi: 10.1186/s12885-021-08088-w.

ABSTRACT

BACKGROUND: While the introduction of checkpoint inhibitors (CPIs) as standard of care treatment for various tumor types has led to considerable improvements in clinical outcome, the majority of patients still fail to respond. Preclinical data suggest that stereotactic body radiotherapy (SBRT) could work synergistically with CPIs by acting as an in situ cancer vaccine, thus potentially increasing response rates and prolonging disease control. Though SBRT administered concurrently with CPIs has been shown to be safe, evidence of its efficacy from large randomized trials is still lacking. The aim of this multicenter randomized phase II trial is to assess whether SBRT administered concurrently with CPIs could prolong progression-free survival as compared to standard of care in patients with advanced solid tumors.

METHODS/DESIGN: Ninety-eight patients with locally advanced or metastatic disease will be randomized in a 1:1 fashion to receive CPI treatment combined with SBRT (Arm A) or CPI monotherapy (Arm B). Randomization will be stratified according to tumor histology (melanoma, renal, urothelial, head and neck squamous cell or non-small cell lung carcinoma) and disease burden (≤ or > 3 cancer lesions). The recommended SBRT dose is 24Gy in 3 fractions, which will be administered to a maximum of 3 lesions and is to be completed prior to the second or third CPI cycle (depending on CPI treatment schedule). The study’s primary endpoint is progression-free survival as per iRECIST. Secondary endpoints include overall survival, objective response, local control, quality of life and toxicity. Translational analyses will be performed using blood, fecal and tissue samples.

DISCUSSION: The CHEERS trial will provide further insights into the clinical and immunological impact of SBRT when combined with CPIs in patients with advanced solid tumors. Furthermore, study results will inform the design of future immuno-radiotherapy trials.

TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03511391 . Registered 17 April 2018.

PMID:33962592 | DOI:10.1186/s12885-021-08088-w

BMC Infect Dis. 2021 May 7;21(1):429. doi: 10.1186/s12879-021-06127-2.

ABSTRACT

BACKGROUND: Hydatidosis is a zoonotic disease and has a great general and economic health importance in both developed and developing countries. Therefore, this systematic and meta-analytic study was conducted to determine the prevalence of cystic echinococcosis in slaughtered livestock in Iran.

METHODS: The present study was conducted as a systematic review and meta-analysis. The SID & Magiran, MEDLINE (PubMed), ScienceDirect, Scopus, and Google Scholar databases were searched with a view to selecting relevant research works. As a result, 31 articles published from April 1970 to April 2020 were selected. The heterogeneity of the studies was assessed using the I² index. Data analysis was conducted within the Comprehensive Meta-Analysis software (CMA) v.3.0 (Biostat, Englewood, NJ, USA) and Arc map (ArcGIS 10.3) software.

RESULTS: The heterogeneity of the studies was evaluated using the I² test which value was 99% showing a high heterogeneity in the studies. The results of publication bias in studies were evaluated by the Egger test, which were not statistically significant (P = 0.144). The overall prevalence of cystic echinococcosis in slaughtered livestock in Iran is 13.9% (95%CI: 10.7-17.7%). The results of the meta-regression analysis indicate the increasing trend of the hydatid cyst prevalence with the increase of sample size and publication year (P < 0.05).

CONCLUSION: According to the results of this study and the relatively high prevalence of cystic echinococcosis in slaughtered livestock in Iran, health policy makers should make effective decisions in this regard, and implement careful inspections and interventions by experts and health authorities.

PMID:33962578 | DOI:10.1186/s12879-021-06127-2

BMC Cancer. 2021 May 7;21(1):512. doi: 10.1186/s12885-021-08026-w.

ABSTRACT

BACKGROUND: Definitive radiation therapy (dRT) is an effective initial treatment of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). PSMA PET/CT is superior to standard of care imaging (CT, MRI, bone scan) for detecting regional and distant metastatic PCa. PSMA PET/CT thus has the potential to guide patient selection and the planning for dRT and improve patient outcomes.

METHODS: This is a multicenter randomized phase 3 trial (NCT04457245). We will randomize 312 patients to proceed with standard dRT (control Arm, n = 150), or undergo a PSMA PET/CT scan at the study site (both 18F-DCFPyL and 68Ga-PSMA-11 can be used) prior to dRT planning (intervention arm, n = 162). dRT will be performed at the treating radiation oncologist facility. In the control arm, dRT will be performed as routinely planned. In the intervention arm, the treating radiation oncologist can incorporate PSMA PET/CT findings into the RT planning. Androgen deprivation therapy (ADT) is administered per discretion of the treating radiation oncologist and may be modified as a result of the PSMA PET/CT results. We assume that approximately 8% of subjects randomized to the PSMA PET arm will be found to have M1 disease and thus will be more appropriate candidates for long-term systemic or multimodal therapy, rather than curative intent dRT. PET M1 patients will thus not be included in the primary endpoint analysis. The primary endpoint is the success rate of patients with unfavorable IR and HR PCa after standard dRT versus PSMA PET-based dRT. Secondary Endpoints (whole cohort) include progression free survival (PFS), metastasis-free survival after initiation of RT, overall survival (OS), % of change in initial treatment intent and Safety.

DISCUSSION: This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET/CT molecular imaging can improve outcomes in patients with PCa who receive dRT. In this trial the incorporation of PSMA PET/CT may improve the success rate of curative intent radiotherapy in two ways: to optimize patient selection as a biomarker and to personalizes the radiotherapy plan.

CLINICAL TRIAL REGISTRATION: UCLA IND#147591 ○ Submission: 02.27.2020 ○ Safe-to-proceed letter issued by FDA: 04.01.2020 UCLA IRB #20-000378 ClinicalTrials.gov Identifier NCT04457245 . Date of Registry: 07.07.2020. Essen EudraCT 2020-003526-23.

PMID:33962579 | DOI:10.1186/s12885-021-08026-w

BMC Cancer. 2021 May 7;21(1):516. doi: 10.1186/s12885-021-08175-y.

ABSTRACT

BACKGROUND: In 2020, Morocco recorded more than 59,370 new cases of cancer and more than 35,265 cases of death (International Agency for Research on Cancer, Annual report Morocco, 2020). Cancer is always accompanied by socially constructed, differentiated, and contingent interpretations and practices according to the socio-cultural and religious characteristics of each region. The study aims at describing the evolution of the socio-cultural and religious aspects of Moroccan cancer patients followed at the National Institute of Oncology (NIO) of Rabat between 2010 and 2020.

METHODS: We have prospectively studied all cancer cases diagnosed at the National Oncology Institute (NIO), Rabat in 2019. We have collected 1102 cases. The data collected was compared with the results of the study carried out in 2010 (1600 cases). Statistical analysis has been assessed by SPSS 20 software and the correlations between socio-cultural characteristics were examined using a chi-square test.

RESULTS: From a socio-economic point of view, almost all patients claim that cancer is a costly disease as well as a disease that leads to a drop in income and the inevitable impoverishment of Moroccan patients. The illiteracy rate is still high; rising from 38% in 2010 to 42.80% in 2020. On the psychological level, damage to body image (alopecia, mastectomy, hysterectomy,) can lead to stigmatizing and harms the marital relationship. The number of patients experiencing divorce and marital separation that seems to occur following cancer pathology remains high, despite a decrease of nearly 50% between 2010 and 2020. Concerning the spiritual aspect, in the Arab-Amazigh-Muslim culture, the impact of the occurrence of cancer is very particular, and the repercussions are assessed differently depending on the degree of conviction. For practicing believers, cancer is considered a divine test and an opportunity to improve. In the Qur’an, God tests the best of his disciples to reward them The rate of practicing believers has evolved from 49% in 2010 to 85.50% in 2020.But for non-practicing believers, cancer is regarded as a divine punishment coming from outside. New behaviors reported by this research concern the use of “roquia”. This spiritual cure is considered as an anti-cancer remedy. It uses Allah’s words from the holy “qur’an”, his faires names and his attributes. 42% of patients use “roquia”. Concerning phytotherapy, there was an increase in the percentage of participants using medicinal plants and even the most harmful plants (Arestiloch, Euphorbia) from 26% in 2010 to 51.50% in 2020.

CONCLUSION: The precarious social level of cancer patients, the lack of social and medical coverage, illiteracy, and lack of knowledge of religion, as well as dissatisfaction with conventional medicine, may lead patients to the use of traditional medicine (medicinal plants, visit of “marabouts”, “roquia”). This can have a negative impact on the quality of access to oncology care.

PMID:33962584 | DOI:10.1186/s12885-021-08175-y

BMC Cancer. 2021 May 7;21(1):517. doi: 10.1186/s12885-021-08204-w.

ABSTRACT

BACKGROUND: CA19-9 is one of the most widely used tumor markers in biliary-pancreatic diseases. The measured value may not factually reflect the genuine CA19-9 level secreted by tumor, which affected by biliary obstruction. There is an urgent need of developing a correction formula of CA19-9 in biliary obstructive patients to guide clinical practice and avoid making improper clinical decision.

METHODS: Clinical characteristics were collected among patients undergoing biliary drainage in our hospital between January 2014 and January 2019. By comparing the malignant and benign patients statistically, dynamic change trend of CA19-9 levels after biliary drainage was obtained. The correction formulas of CA19-9 were generated by means of linear regression.

RESULTS: 121 patients, including 102 malignant and 19 benign patients, were enrolled in this study. The baseline CA19-9 level of malignant patients is much higher than that of benign patients. Total bilirubin (TB) level was found to be not related with CA19-9 value (p = 0.109). The drop proportion of the average CA19-9 level in the malignant patients (39.2%, IQR -18.4-78.6%) was much lower than that in the benign patients (75.7%, IQR 58.1-86.6%) (p = 0.014). The correction formula, CA19-9_True = 0.63 × CA19-9_Measured – 20.3 (R² = 0.693, p<0.001), was generated based on the linear relation between CA19-9 after drainage and CA19-9 before drainage in malignant patients, which had similar diagnostic value with true CA19-9 value.

CONCLUSIONS: Quantitative correction formulas of CA19-9 considering the effect of biliary decompression was first proposed in this study, aiming to provide a more accurate CA19-9 level to make more accurate clinical decision and avoid making improper therapeutic schedule.

PMID:33962560 | DOI:10.1186/s12885-021-08204-w

BMC Anesthesiol. 2021 May 7;21(1):139. doi: 10.1186/s12871-021-01360-3.

ABSTRACT

PURPOSE: To investigate the effect of dexmedetomidine on intraoperative blood glucose hemostasis in elderly patients undergoing non-cardiac major surgery.

METHODS: This was secondary analysis of a randomized controlled trial. Patients in dexmedetomidine group received a loading dose dexmedetomidine (0.6 μg/kg in 10 min before anaesthesia induction) followed by a continuous infusion (0.5 μg/kg/hr) till 1 h before the end of surgery. Patients in control group received volume-matched normal saline at the same time interval. Primary outcome was the incidence of intraoperative hyperglycemia (blood glucose higher than 10 mmol/L).

RESULTS: 303 patients in dexmedetomidine group and 306 patients in control group were analysed. The incidence of intraoperative hyperglycemia showed no statistical significance between dexmedetomidine group and control group (27.4% vs. 22.5%, RR = 1.22, 95%CI 0.92-1.60, P = 0.167). Median value of glycemic variation in dexmedetomidine group (2.5, IQR 1.4-3.7, mmol) was slightly lower than that in control group (2.6, IQR 1.5-4.0, mmol), P = 0.034. In multivariable logistic analysis, history of diabetes (OR 3.007, 95%CI 1.826-4.950, P < 0.001), higher baseline blood glucose (OR 1.353, 95%CI 1.174-1.560, P < 0.001) and prolonged surgery time (OR 1.197, 95%CI 1.083-1.324, P < 0.001) were independent risk factors of hyperglycaemia.

CONCLUSIONS: Dexmedetomidine presented no effect on intraoperative hyperglycemia in elderly patients undergoing major non-cardiac surgery.

TRIAL REGISTRATION: Present study was registered at Chinese Clinical Trial Registry on December 1, 2015 ( www.chictr.org.cn , registration number ChiCTR-IPR-15007654).

PMID:33962565 | DOI:10.1186/s12871-021-01360-3