Category: Statistics

J Orthop Surg Res. 2022 Oct 7;17(1):443. doi: 10.1186/s13018-022-03332-w.

ABSTRACT

BACKGROUND: Medical devices are used in almost all orthopedic surgical subspecialties, and the frequency of adverse events is increasing, which should not be ignored. To provide suggestions on how to avoid implant recalls from the perspective of manufacturers, medical institutions and supervisions, as well as how to respond promptly to adverse events.

METHODS: The research extracted recalls of osteosynthesis implants and joint replacement implants from January 1, 2011, to June 30, 2021, in the CNMPA, FDA, HC and ATGA websites and collected the information on device name, recall time, recall class, recall manufacturer, device classification and affected areas. Moreover, the McKinsey 7S model and fishbone diagram were used to analyze recall reasons.

RESULTS: A total of 315 cases of osteosynthesis implants and 286 cases of joint replacement implants were reported in China, the USA, Canada and Australia. The recalls number from 2016 to 2021 was more than that from 2011 to 2015 for osteosynthesis implant (p = 0.012) and joint replacement implant (p = 0.002), and both mainly focused on class II (76.19% and 78.32%). There were statistical differences in the four countries for both implants (p = 0.000), especially osteosynthesis implant between China and the USA (p = 0.000), China and Canada (p = 0.001), the USA and Australia (p = 0.002), and joint replacement implant between China and Australia (p = 0.000).

CONCLUSIONS: To avoid the recalls of such implants, manufacturers should strictly select implant materials and components, develop detailed labels and instructions, severely control the packaging process and establish the integrity of medical device data. Medical institutions should standardize procurement procedures, use qualified equipment and train medical workers. It also requires supervisions to conduct premarket safety assessments. In addition, regulators should strengthen supervision and establish reporting systems to deal with the occurrence of adverse events promptly.

PMID:36207755 | DOI:10.1186/s13018-022-03332-w

Popul Health Metr. 2022 Oct 7;20(1):19. doi: 10.1186/s12963-022-00296-1.

ABSTRACT

BACKGROUND: Most cancer disability-adjusted life year (DALY) studies worldwide have used broad, generic disability weights (DWs); however, differences exist among populations and types of cancers. Using breast cancer as example, this study aimed to estimate the population-level DALYs in females in China and the impact of screening as well as applying local DWs.

METHODS: Using multisource data, a prevalence-based model was constructed. (1) Overall years lived with disability (YLDs) were estimated by using numbers of prevalence cases, stage-specific proportions, and local DWs for breast cancer. Numbers of females and new breast cancer cases as well as local survival rates were used to calculate the number of prevalence cases. (2) Years of life lost (YLLs) were estimated using breast cancer mortality rates, female numbers and standard life expectancies. (3) The prevalence of and mortality due to breast cancer and associated DALYs from 2020 to 2030 were predicted using Joinpoint regression. (4) Assumptions considered for screening predictions included expanding coverage, reducing mortality due to breast cancer and improving early-stage proportion for breast cancer.

RESULTS: In Chinese females, the estimated number of breast cancer DALYs was 2251.5 thousand (of 17.3% were YLDs) in 2015, which is predicted to increase by 26.7% (60.3% among those aged ≥ 65 years) in 2030 (2852.8 thousand) if the screening coverage (25.7%) stays unchanged. However, if the coverage can be achieved to 40.7% in 2030 (deduced from the “Healthy China Initiative”), DALYs would decrease by 1.5% among the screened age groups. Sensitivity analyses found that using local DWs would change the base-case values by ~ 10%.

CONCLUSION: Estimates of DALYs due to breast cancer in China were lower (with a higher proportion of YLDs) than Global Burden of Disease Study numbers (2527.0 thousand, 8.2% were YLDs), suggesting the importance of the application of population-specific DWs. If the screening coverage remains unchanged, breast cancer-caused DALYs would continue to increase, especially among elderly individuals.

PMID:36207752 | DOI:10.1186/s12963-022-00296-1

Malar J. 2022 Oct 7;21(1):286. doi: 10.1186/s12936-022-04304-5.

ABSTRACT

BACKGROUND: Plasmodium falciparum resistance to series of anti-malarial drugs is a major challenge in efforts to control and/or eliminate malaria globally. In 1998, following the widespread of chloroquine (CQ) resistant P. falciparum, Ethiopia switched from CQ to sulfadoxine-pyrimethamine (SP) and subsequently in 2004 from SP to artemether-lumefantrine (AL) for the treatment of uncomplicated falciparum malaria. Data on the prevalence of CQ resistance markers after more than two decades of its removal is important to map the selection pressure behind the targets codons of interest. The present study was conducted to determine the prevalence of mutations in Pfcrt K76T and Pfmdr1 N86Y codons among malaria-infected patients from Adama, Olenchiti and Metehara sites of East Shewa zone, Oromia Regional State, Ethiopia.

METHODS: Finger-prick whole blood samples were collected on 3MM Whatman ® filter papers from a total of 121 microscopically confirmed P. falciparum infected patients. Extraction of parasite DNA was done by Chelex-100 method from dried blood spot (DBS). Genomic DNA template was used to amplify Pfcrt K76T and Pfmdr1 N86Y codons by nested PCR. Nested PCR products were subjected to Artherobacter protophormiae-I (APoI) restriction enzyme digestion to determine mutations at codons 76 and 86 of Pfcrt and Pfmdr1 genes, respectively.

RESULTS: Of 83 P. falciparum isolates successfully genotyped for Pfcrt K76T, 91.6% carried the mutant genotypes (76T). The prevalence of Pfcrt 76T was 95.7%, 92.5% and 84.5% in Adama, Metehara and Olenchiti, respectively. The prevalence of Pfcrt 76T mutations in three of the study sites showed no statistical significance difference (χ² = 1.895; P = 0.388). On the other hand, of the 80 P. falciparum samples successfully amplified for Pfmdr1, all carried the wild-type genotypes (Pfmdr1 N86).

CONCLUSION: Although CQ officially has been ceased for the treatment of falciparum malaria for more than two decades in Ethiopia, greater proportions of P. falciparum clinical isolates circulating in the study areas carry the mutant 76T genotypes indicating the presence of indirect CQ pressure in the country. However, the return of Pfmdr1 N86 wild-type allele may be favoured by the use of AL for the treatment of uncomplicated falciparum malaria.

PMID:36207750 | DOI:10.1186/s12936-022-04304-5

BMC Public Health. 2022 Oct 7;22(1):1872. doi: 10.1186/s12889-022-14273-8.

ABSTRACT

BACKGROUND: Women with disabilities in developing countries experience significant marginalization, which negatively affects their reproductive health. This study examined the association between disability status and sexual intimate partner violence; the determinants of sexual intimate partner violence by disability status; and the variations in the determinants by disability status.

METHODS: The study, which was based on a merged dataset of 2006, 2011 and 2016 Uganda Demographic Surveys, used a weighted sample of 9689 cases of married women selected for the domestic violence modules. Data were analyzed using frequency distributions and chi-squared tests and multivariable logistic regressions. Other key explanatory variables included partner’s alcohol consumption and witnessing parental violence. A model with disability status as an interaction term helped to establish variations in the determinants of sexual intimate partner violence by disability status.

RESULTS: Sexual IPV was higher among women with disabilities (25% compared to 18%). Disability status predicted sexual intimate partner violence with higher odds among women with disabilities (aOR = 1.51; 95% CI 1.10-2.07). The determinants of sexual intimate partner violence for women with disabilities were: partner’s frequency of getting drunk, having witnessed parental violence, occupation, and wealth index. The odds of sexual intimate partner violence were higher among women whose partners often or sometimes got drunk, that had witnessed parental violence, were involved in agriculture and manual work; and those that belonged to the poorer and middle wealth quintiles. Results for these variables revealed similar patterns irrespective of disability status. However, women with disabilities in the agriculture and manual occupations and in the poorer and rich wealth quintiles had increased odds of sexual intimate partner violence compared to nondisabled women in the same categories.

CONCLUSION: Determinants of sexual intimate partner violence mainly relate to partners’ behaviors and the socialization process. Addressing sexual intimate partner violence requires prioritizing partners’ behaviors, and gender norms and proper childhood modelling, targeting men, women, families and communities. Interventions targeting women with disabilities should prioritize women in agriculture and manual occupations, and those above the poverty line.

PMID:36207741 | DOI:10.1186/s12889-022-14273-8

J Cardiothorac Surg. 2022 Oct 7;17(1):260. doi: 10.1186/s13019-022-02016-0.

ABSTRACT

OBJECTIVE: Cardiothoracic surgery is a large field in Australia, and evidence suggests post-cardiopulmonary bypass (CPB) hyperlactataemia is associated with higher morbidity and mortality. Low thiamine levels are a potentially common yet treatable cause of hyperlactataemia and may occur in the setting of exposure to CPB non-biological material. We hypothesized that cardiopulmonary bypass would result in decreased whole-blood thiamine levels, which may therefore result in increased whole-blood lactate levels in the post-operative period.

METHODS: Adult patients undergoing non-emergent CPB were recruited in a single centre, prospective, analytic observational study at Townsville University Hospital, Australia. The primary outcome was a comparison of pre- and post-CPB thiamine diphosphate level, secondarily aiming to assess any relationship between lactate and thiamine levels. Prospective pre- and post-CPB blood samples were taken and analysed at a central reference laboratory.

RESULTS: Data was available for analysis on 78 patients. There was a statistically significant increase in thiamine diphosphate level from pre-CPB: 1.36 nmol/g Hb, standard deviation (SD) 0.31, 95% confidence intervals (CI) 1.29-1.43, to post-CPB: 1.77 nmol/g Hb, SD 0.53, 95% CI 1.43-1.88, p value < 0.001. There was a non-statistically significant (p > 0.05) trend in rising whole-blood lactate levels with increasing time. Analysis of lactate levels at varying time periods found a significant difference between baseline measurements and increased levels at 13-16 h (p < 0.05). There was no significant relationship observed between whole-blood thiamine levels and post-operative lactate levels.

CONCLUSION: Whole-blood thiamine levels were found to increase immediately post-CPB in those undergoing elective cardiac surgery. There was no correlation between whole-blood thiamine levels and post-operative arterial lactate levels.

PMID:36207738 | DOI:10.1186/s13019-022-02016-0

BMC Med Inform Decis Mak. 2022 Oct 7;22(1):261. doi: 10.1186/s12911-022-02006-1.

ABSTRACT

OBJECTIVES: The Charlson comorbidity index (CCI), the most ubiquitous comorbid risk score, predicts one-year mortality among hospitalized patients and provides a single aggregate measure of patient comorbidity. The Quan adaptation of the CCI revised the CCI coding algorithm for applications to administrative claims data using the International Classification of Diseases (ICD). The purpose of the current study is to adapt and validate a coding algorithm for the CCI using the SNOMED CT standardized vocabulary, one of the most commonly used vocabularies for data collection in healthcare databases in the U.S.

METHODS: The SNOMED CT coding algorithm for the CCI was adapted through the direct translation of the Quan coding algorithms followed by manual curation by clinical experts. The performance of the SNOMED CT and Quan coding algorithms were compared in the context of a retrospective cohort study of inpatient visits occurring during the calendar years of 2013 and 2018 contained in two U.S. administrative claims databases. Differences in the CCI or frequency of individual comorbid conditions were assessed using standardized mean differences (SMD). Performance in predicting one-year mortality among hospitalized patients was measured based on the c-statistic of logistic regression models.

RESULTS: For each database and calendar year combination, no significant differences in the CCI or frequency of individual comorbid conditions were observed between vocabularies (SMD ≤ 0.10). Specifically, the difference in CCI measured using the SNOMED CT vs. Quan coding algorithms was highest in MDCD in 2013 (3.75 vs. 3.6; SMD = 0.03) and lowest in DOD in 2018 (3.93 vs. 3.86; SMD = 0.02). Similarly, as indicated by the c-statistic, there was no evidence of a difference in the performance between coding algorithms in predicting one-year mortality (SNOMED CT vs. Quan coding algorithms, range: 0.725-0.789 vs. 0.723-0.787, respectively). A total of 700 of 5,348 (13.1%) ICD code mappings were inconsistent between coding algorithms. The most common cause of discrepant codes was multiple ICD codes mapping to a SNOMED CT code (n = 560) of which 213 were deemed clinically relevant thereby leading to information gain.

CONCLUSION: The current study repurposed an important tool for conducting observational research to use the SNOMED CT standardized vocabulary.

PMID:36207711 | DOI:10.1186/s12911-022-02006-1

BMC Public Health. 2022 Oct 7;22(1):1873. doi: 10.1186/s12889-022-14249-8.

ABSTRACT

BACKGROUND: SARS-CoV-2 (Covid-19 virus) infection exposed the unpreparedness of African countries to health-related issues, South Africa included. Africa recorded more than 211 853 deaths as a consequence of Covid-19. When rare and deadly diseases require urgent hospitalisation strikes, governments and healthcare providers are usually caught unprepared, resulting in huge loss of lives. Usually, at the beginning of such pandemics, there is no rich data for health practitioners and academics to be able to forecast the number of patients or deaths related to the pandemic. This study aims to predict the number of deaths associated with Covid-19 infection. With the availability of the number of deaths on a daily basis, the results stemming from this study are important to inform and plan health policy.

METHODS: This study uses the daily number of deaths due to Covid-19 infection. Exploratory data analysis reveals that the data exhibits non-normality, three structural breaks and volatility clustering characteristics. The Markov switching (MS)-generalized autoregressive conditional heteroscedasticity (GARCH)-type model combined with heavy-tailed distributions is fitted to the returns of the data. Using available daily reported Covid-19-related deaths up until 26 August 2021, we report 10-day ahead forecasts of deaths. All forecasts are compared to the actual observed values in the forecasting period.

RESULTS: The Anderson-Darling Goodness of fit test confirms that the fitted models are adequate for the data. The Kupiec likelihood ratio test and the root mean square error (RMSE) were used to select the robust model at different risk levels. At 95% the MS(3)-GARCH(1,1) combined with Pearson’s type IV distribution (PIVD) is the best model. This indicates that the proposed best-fitting model is reasonable and can be used for predicting the daily number of deaths due to Covid-19.

CONCLUSION: The MS(3)-GARCH(1,1)-PIVD model provides a reliable and accurate method for predicting the minimum number of death due to Covid-19. The accuracy of the proposed model will assist policymakers, academics and health practitioners in forecasting the volatility of future health-related deaths in which the predictability of volatility plays an integral role in health risk management.

PMID:36207700 | DOI:10.1186/s12889-022-14249-8

BMC Pulm Med. 2022 Oct 7;22(1):377. doi: 10.1186/s12890-022-02179-5.

ABSTRACT

BACKGROUND: Vasculogenic mimicry (VM) is a recently identified pattern of blood supply to tumor tissue. It has long been considered a functional element in the metastasis and prognosis of malignant tumors. Both Rho GTPase-activating protein 25 (ARHGAP25) and Ras homolog family member A (RhoA) are effective predictors of tumor metastasis. In this study, we examined the expression levels of ARHGAP25 and RhoA and the structure of VM in non-small cell lung cancer (NSCLC). At the same time, we used cytology-related experiments to explore the effect of ARHGAP25 on the migration ability of tumor cells. Furthermore, we analyzed the interaction between the three factors and their association with clinicopathological characteristics and the five-year survival time in patients using statistical tools.

METHODS: A total of 130 well-preserved NSCLC and associated paracancerous tumor-free tissues were obtained. Cell colony formation, wound healing, and cytoskeleton staining assays were used to analyze the effect of ARHGAP25 on the proliferation and migration ability of NSCLC cells. Immunohistochemical staining was used to determine the positivity rates of ARHGAP25, RhoA, and VM. Statistical software was used to examine the relationships between the three factors and clinical case characteristics, overall survival, and disease-free survival.

RESULTS: Cell colony formation, wound healing, and cytoskeleton staining assays confirmed that ARHGAP25 expression affects the proliferation and migratory abilities of NSCLC cells. ARHGAP25 positivity rates in NSCLC and paracancerous tumor-free tissues were 48.5% and 63.1%, respectively, whereas RhoA positivity rates were 62.3% and 18.5%, respectively. ARHGAP25 had a negative relationship with RhoA and VM, whereas RhoA and VM had a positive relationship (P < 0.05). ARHGAP25, RhoA, and VM affected the prognosis of patients with NSCLC (P < 0.05) according to Kaplan-Meier of survival time and Cox regression analyses. Furthermore, lowering ARHGAP25 expression increased NSCLC cell proliferation and migration.

CONCLUSIONS: ARHGAP25 and RhoA expression is associated with VM and may be of potential value in predicting tumor metastasis, prognosis, and targeted therapy.

PMID:36207695 | DOI:10.1186/s12890-022-02179-5

BMC Cancer. 2022 Oct 7;22(1):1050. doi: 10.1186/s12885-022-10129-x.

ABSTRACT

BACKGROUND: Uterine sarcomas are rare and aggressive gynaecologic malignancies, characterized by a relatively high recurrence rate and poor prognosis. The aim of this study was to investigate the clinicopathological features and explore the prognostic factors of these malignancies.

METHODS: This was a single-institution, retrospective study. We reviewed the medical records of 155 patients with pathologically confirmed uterine sarcomas including uterine leiomyosarcoma (ULMS), low-grade endometrial stromal sarcoma (LG-ESS), high-grade endometrial stromal sarcoma (HG-ESS), undifferentiated uterine sarcoma (UUS) and adenosarcoma (AS) between 2006 and 2022. A total of 112 patients who underwent surgery between January 2006 and April 2019 were included in the survival analysis. The current study recorded the clinicopathological, treatment and outcome data to determine clinical characteristics and survival.

RESULTS: The most common histopathological type was ULMS (63/155, 40.64%), followed by LG-ESS (56/155, 36.13%) and HG-ESS (16/155, 10.32%). The mean age at diagnosis of all patients was 49.27±48.50 years and 32.90% (51/155) of patients were postmenopausal. Fifteen patients underwent fast-frozen sectioning, 63(54.78%) were diagnosed with malignancy, 29(25.22%) were highly suspected of malignancy that needed further clarification and 23(14.84%) were diagnosed with benign disease. A total of 124(80%) patients underwent total hysterectomy (TH) and salpingo-oophorectomy. Multivariate analyses showed that histological type and tumour size were independent prognostic factors both for overall survival (OS) (p<0.001 and P=0.017, respectively) and progression-free survival (PFS) (p<0.001 and P=0.018, respectively). Tumour stage was only significantly associated with PFS (P=0.002). Elevated preoperative NLR, PLR and postmenopausal status were significantly correlated with shorter PFS and OS in univariate analysis, but no statistically significant difference was found in multivariate analysis.

CONCLUSIONS: In patients with uterine sarcoma, in comparison to LMS and LG-ESS, UUS and HG-ESS tend to present as more aggressive tumour with poorer outcomes. Furthermore, larger tumour (>7.5 cm) were an important predictor of shorter PFS and OS.

PMID:36207687 | DOI:10.1186/s12885-022-10129-x

BMC Geriatr. 2022 Oct 7;22(1):785. doi: 10.1186/s12877-022-03420-w.

ABSTRACT

BACKGROUND: Rehabilitation potential involves predicting who will benefit from rehabilitation. Decisions about rehabilitation potential must take into account personal, clinical and contextual factors, a process which is complicated in the presence of acute ill-health and frailty. This study aimed to evaluate the feasibility and acceptability of the Rehabilitation Potential Assessment Tool (RePAT) – a 15 item holistic, person-centred assessment tool and training package – in the acute hospital setting.

METHODS: A non-randomised feasibility study with nested semi-structured interviews explored whether RePAT was feasible and acceptable. Feasibility was tested by recruiting physiotherapy and occupational therapy participants delivering the RePAT intervention to patients alongside usual clinical care. Acceptability was tested by conducting semi-structured interviews with staff, patient and carer participants. Staff and patient characteristics were analysed using descriptive statistics. Interview data were analysed thematically. Fidelity of completed RePAT items was assessed against a priori criteria on how closely they matched tool guidance by two researchers. Mean values of the two scores were calculated. RePAT content was analysed and supported with verbatim quotes.

RESULTS: Six staff participants were recruited and trained. They assessed 26 patient participants using RePAT. Mean (SD) patient age was 86.16 (±6.39) years. 32% were vulnerable or mildly frail, 42% moderately frail and 26% severely or very severely frail using the Clinical Frailty Scale. Mean (SD) time to complete RePAT was 32.7 (±9.6) minutes. RePAT fidelity was good where 13 out of 15 items achieved a priori fidelity. RePAT was acceptable and tolerated by staff and patients. Staff participants reported RePAT enabled them to consider rehabilitation decisions in a more structured and consistent way. Patients and carer participants, although unable to comment directly on RePAT, reported being satisfied with their rehabilitation assessments which were found to embrace a person-centred approach.

CONCLUSIONS: RePAT was found to be acceptable and feasible by staff, carers and patients. It allowed clinicians to make explicit their reasoning behind rehabilitation assessments and encouraged them to become more cognisant of factors which affected their clinical decision-making.

TRIAL REGISTRATION: ID ISRCTN31938453 . Registered 05/10/2021.

PMID:36207681 | DOI:10.1186/s12877-022-03420-w