Category: Statistics

BMC Pregnancy Childbirth. 2023 Jan 28;23(1):76. doi: 10.1186/s12884-022-05243-4.

ABSTRACT

BACKGROUND: This systematic review aims to explore the prevalence of the impact of the COVID-19, MERS, and SARS pandemics on the mental health of pregnant women.

METHODS: All COVID-19, SARS and MERS studies that evaluated the mental health of pregnant women with/without gynaecological conditions that were reported in English between December 2000 – July 2021 were included. The search criteria were developed based upon the research question using PubMed, Science Direct, Ovid PsycINFO and EMBASE databases. A wide search criterion was used to ensure the inclusion of all pregnant women with existing gynaecological conditions. The Newcastle-Ottawa-Scale was used to assess the risk of bias for all included studies. Random effects model with restricted maximum-likelihood estimation method was applied for the meta-analysis and I-square statistic was used to evaluate heterogeneity across studies. The pooled prevalence rates of symptoms of anxiety, depression, PTSD, stress, and sleep disorders with 95% confidence interval (CI) were computed.

RESULTS: This systematic review identified 217 studies which included 638,889 pregnant women or women who had just given birth. There were no studies reporting the mental health impact due to MERS and SARS. Results showed that women who were pregnant or had just given birth displayed various symptoms of poor mental health including those relating to depression (24.9%), anxiety (32.8%), stress (29.44%), Post Traumatic Stress Disorder (PTSD) (27.93%), and sleep disorders (24.38%) during the COVID-19 pandemic.

DISCUSSION: It is important to note that studies included in this review used a range of outcome measures which does not allow for direct comparisons between findings. Most studies reported self-reported measure of symptoms without clinical diagnoses so conclusions can be made for symptom prevalence rather than of mental illness. The importance of managing mental health during pregnancy and after-delivery improves the quality of life and wellbeing of mothers hence developing an evidence-based approached as part of pandemic preparedness would improve mental health during challenging times.

OTHER: The work presented in this manuscript was not funded by any specific grants. A study protocol was developed and published in PROSPERO (CRD42021235356) to explore several key objectives.

PMID:36709255 | DOI:10.1186/s12884-022-05243-4

BMC Public Health. 2023 Jan 28;23(1):192. doi: 10.1186/s12889-023-15021-2.

ABSTRACT

BACKGROUND: Regulatory authorities register medicines for patients to access them within a reasonable period of time. There is a paucity of available data regarding the extent to which registered medicines reach the public after market authorisation is granted by the South African Health Products Regulatory Authority (SAHPRA). This is important since time spent by SAHPRA assessing medicines that are subsequently not launched onto the South African market means time wasted, which could be spent on assessing new medicines that address an unmet need in the country. Consequently, we initially analysed the time taken for registered medicines to reach patients and the relationship between medicines registered at SAHPRA and those subsequently dispensed in private pharmacies. The extent of registration of multiple sourced versus new patented medicines was also explored.

METHODS: A retrospective, descriptive and quantitative investigation was conducted for medicines registered between 2014 and 2019. Registered and dispensed medicines were compared to establish accessibility post registration. Data sources included SAHPRA and IQVIA datasets. Microsoft Excel and SAS were used for data storage, analysis, and computation of descriptive statistical analysis.

RESULTS: Of (N = 2175) registered medicines, only 358 (16.5%; 95% CI 15.0%-18.1%) were dispensed to patients, and out of 1735 medicines registered between 2015 and 2019, only 57 (3.3%; 95% CI 2.5%-4.2%) were dispensed during the study period. Medicines acting on the central nervous system were registered and dispensed the most at 21.0% and 18.0%, respectively, whereas antineoplastic and immunomodulation agents were registered and dispensed only 11% and 5%, respectively. A concern was that only 13.0% of registered medicines were originators, with most either as generics, including branded generics, or pseudo-generics.

CONCLUSION: Regulatory measures should be implemented to ensure increased medicine access post-registration for new originators, especially for priority disease areas that benefit patients. Mental health diseases and improved access to oncology medicines require special attention and further investigation in South Africa.

PMID:36709246 | DOI:10.1186/s12889-023-15021-2

Knee Surg Sports Traumatol Arthrosc. 2023 Jan 28. doi: 10.1007/s00167-023-07321-2. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the clinical and radiological outcomes of arthroscopic superior capsular reconstruction (SCR) using hybrid grafts composed of tensor fascia lata autografts and human dermal allografts.

METHODS: This study included 30 patients with chronic irreparable posterosuperior rotator cuff tears (RCTs) who underwent arthroscopic SCR using a hybrid graft composed of tensor fascia lata autograft and human dermal allograft. Clinical outcomes were evaluated using the pain visual analogue scale score, shoulder range of motion, American Shoulder and Elbow Surgeons score, constant score, University of California-Los Angeles score, and simple shoulder test score preoperatively and at least 2 years after surgery. Radiographic analysis included the Hamada classification grade, acromiohumeral distance (AHD), and graft integrity at 2 years after surgery.

RESULTS: All patients exhibited significant clinical improvement in all functional outcome measurements, except external rotation (all P < 0.05). The number of patients who exhibited pseudoparalysis decreased from 7 (23.3%) to 2 (6.7%) postoperatively. Complications were not observed. Radiologically, the mean postoperative AHD increased significantly from 6.9 ± 1.6 cm to 8.8 ± 2.1 cm at 2 years postoperatively (P < 0.001). Twenty five out of the 30 (83.3%) patients showed successful graft healing, and all healing failures occurred on the humeral side. The differences between the healed-graft and failed-graft groups were significantly lower graft thickness (P = 0.001) and smaller AHD (P < 0.001) in the failed-graft group. Every functional outcome scores were not statistically different between healed-graft and failed-graft groups.

CONCLUSIONS: An arthroscopic SCR technique using a hybrid graft consisting of a tensor fascia lata autograft and human dermal allograft showed satisfactory clinical outcomes in patients with irreparable RCTs.

LEVEL OF EVIDENCE: IV.

PMID:36709237 | DOI:10.1007/s00167-023-07321-2

Ann Biomed Eng. 2023 Jan 28. doi: 10.1007/s10439-022-03133-6. Online ahead of print.

ABSTRACT

To improve abdominal aortic aneurysm (AAA) rupture risk assessment, a large, longitudinal study on AAA hemodynamics and biomechanics is necessary, using personalized fluid-structure interaction (FSI) modeling. 3-dimensional, time-resolved ultrasound (3D+t US) is the preferred image modality to obtain the patient-specific AAA geometry for such a study, since it is safe, affordable and provides temporal information. However, the 3D+t US field-of-view (FOV) is limited and therefore often fails to capture the inlet and aorto-iliac bifurcation geometry. In this study, a framework was developed to add parametric inlet and bifurcation geometries to the abdominal aortic aneurysm geometry by employing dataset statistics and parameters of the AAA geometry. The impact of replacing the patient-specific inlet and bifurcation geometries, acquired using computed tomography (CT) scans, by parametric geometries was evaluated by examining the differences in hemodynamics (systolic and time-averaged wall shear stress and oscillatory shear index) in the aneurysm region. The results show that the inlet geometry has a larger effect on the AAA hemodynamics (median differences of 7.5 to 18.8%) than the bifurcation geometry (median differences all below 1%). Therefore, it is not feasible to replace the patient-specific inlet geometry by a generic one. Future studies should investigate the possibilities of extending the proximal FOV of 3D+t US. However, this study did show the feasibility of adding a parametric bifurcation geometry to the aneurysm geometry. After extending the proximal FOV, the obtained framework can be used to extract AAA geometries from 3D+t US for FSI simulations, despite the absence of the bifurcation geometry.

PMID:36709232 | DOI:10.1007/s10439-022-03133-6

Eye (Lond). 2023 Jan 28. doi: 10.1038/s41433-023-02404-3. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVES: To report the incidence, microbiological profile and in-vitro antimicrobial susceptibilities of microbial keratitis (MK) in the East of England (EoE) over a 6-year period.

SUBJECTS/METHODS: A retrospective study of patients diagnosed with MK who underwent corneal scraping at participating trusts, within the EoE, between 01/01/2015-01/07/2020. Analysis was performed on MK isolate profiles, in-vitro anti-microbial sensitivities and trends over time.

RESULTS: The mean incidence of IK, in the EoE, was estimated at 6.96 per 100 000 population/year. 1071 corneal scrapes were analysed, 460 were culture positive (42.95%) of which 87.2% were bacteria (50.3% gram-positive and 49.7% gram-negative), 2.4% polymicrobial, 9.3% fungi and 1.1% acanthamoeba. The most common organisms were pseudomonas spp (29.57%). There was a non-statistically significant trend (NST) in increasing incidence of pseudomonas spp, staph aureus and serratia (p = 0.719, p = 0.615, and p = 0.099 respectively) and a declining NST in Fungi (p = 0.058). Susceptibilities in-vitro to, penicillin classes, fluoroquinolone and aminoglycosides were 76.7% and 89.4%, 79.2% and 97.2% and 95.4 and 96.1% to gram-positive and gram-negative bacteria respectively. Gram-negative organisms were increasingly resistant to cephalosporins with a 19.2% reduction in sensitivity over time. (p = 0.011). Ceftriaxone showed the greatest decrease in sensitivity of 41.67% (p = 0.006).

CONCLUSION: In the EoE, MK is relatively prevalent though likely underestimated. Profiles are similar to other UK regions with the exception of a higher fungal and lower acanthamoeba incidence. Common first and second-line antimicrobial selection provides, on the whole, good coverage. Nevertheless, anti-microbial resistance, to cephalosporins, was observed so selection should be carefully considered when treating MK empirically.

PMID:36709219 | DOI:10.1038/s41433-023-02404-3

Zhonghua Xue Ye Xue Za Zhi. 2022 Oct 14;43(10):818-825. doi: 10.3760/cma.j.issn.0253-2727.2022.10.004.

ABSTRACT

Objective: To explore the risk factors in leukemia transformation (LT) in those with myelodysplastic syndromes (MDS) . Methods: From January 2012 to December 2020,data on 320 patients with newly diagnosed primary MDS were gathered from the MDS center. The clinical features and molecular characteristics are explored. Additionally, a retrospective analysis of risk factors for the development of acute leukemia from MDS was done. Results: The median follow-up was13.6 (0.4-107.3) months. 23.4% (75/320) of the MDS patients had LT group. Significant differences between the LT group and non-LT group can be seen in age (P<0.001) , bone marrow blast percentage (P<0.001) , bone marrow fibrosis (P=0.046) , WHO classification (P<0.001) , IPSS-R (P<0.001) and IPSS-R karyotype group (P=0.001) . The median number of mutation of LT group was 1 (1, 3) , that in non-LT group was 1 (0, 2) ,which had a statistical difference (P=0.003) .At the time of the initial diagnosis of MDS, the LT group had higher rates of the TP53 mutation (P=0.034) , DNMT3A mutation (P=0.026) , NRAS mutation (P=0.027) and NPM1 mutation (P=0.017) . Compared with the mutations at first diagnosis and LT of six patients, the number of mutations increased and the variant allele frequencies (VAF) increased significantly in LT patients. Higher bone marrow blast percentage (Refer to <5% , 5% -10% : HR=4.587, 95% CI 2.214 to 9.504, P<0.001, >10% : HR=9.352, 95% CI 4.049 to 21.600, P<0.001) , IPSS-R cytogenetic risk groups (HR=2.603, 95% CI 1.229-5.511, P=0.012) , DNMT3A mutation (HR=4.507, 95% CI 1.889-10.753, P=0.001) , and NPM1 mutation (HR=3.341, 95% CI 1.164-9.591, P=0.025) were all independently associated with LT in MDS patients, according to results of multivariate Cox regression. Conclusion: Bone marrow blast percentage, IPSS-R cytogenetic risk groups, DNMT3A mutation, and NPM1 mutation are independent risk factors in LT for MDS patients.

PMID:36709195 | DOI:10.3760/cma.j.issn.0253-2727.2022.10.004

Zhonghua Xue Ye Xue Za Zhi. 2022 Aug 14;43(8):657-662. doi: 10.3760/cma.j.issn.0253-2727.2022.08.007.

ABSTRACT

Objective: This study aimed to evaluate the efficacy and safety of lenalidomide combined with bortezomib and dexamethasone (VRD) in the treatment of newly diagnosed multiple myeloma (MM) . Methods: A total of 150 newly diagnosed patients with MM diagnosed in The First Affiliated Hospital of Soochow University from November 2018 to February 2021 and received VRD as the induction regimen were included to evaluate the safety and efficacy of VRD induction therapy for newly diagnosed MM. Results: The median follow-up was 22 months, two patients (1.3%) died early after treatment, and 148 patients (98.7%) completed induction therapy. 116 patients (77.3%) were mobilized to collect autologous hematopoietic stem cells, 101 cases (87.1%) were qualified in the collection, of which 48 cases (41.4%) were excellent in the collection. The 3-year progression-free survival (PFS) rate was 59%, and the 3-year overall survival (OS) rate was 83%. After induction, complete remission (CR) /stringent CR rate was 54.4%, ≥ very good partial remission rate was 77.3%, overall response rate was 86.0%, and minimal residual disease negative rate was 46.0%. There was no statistically significant difference in the efficacy of cytogenetic high-risk patients compared with standard risk patients (P=0.456) . The median PFS time of cytogenetic high-risk patients was shorter than that of standard risk patients (not reached vs 33 months, P=0.014) . There was no statistically significant difference in the median OS time (not reached vs not reached, P=0.072) . The highest incidence of hematological adverse events was thrombocytopenia (72%) , followed by neutropenia (42%) and anemia (20%) . The highest incidence of non-hematological adverse events was peripheral neuritis (56.7%) . The main digestive tract symptoms include constipation (30.0%) and diarrhea (17.3%) . Upper respiratory tract infection (23.3%) and lung infection (7.3%) are the main infections. The incidence of adverse thrombocytopenia (90.0% vs 63.7%, P=0.001) , neutropenia (54.2% vs 36.3%, P=0.038) , anemia (33.3% vs 13.7%, P=0.005) , diarrhea (27.1% vs 12.7%, P=0.030) , limb edema (20.8% vs 3.9%, P=0.030) , fever (20.8% vs 4.9%, P=0.006) , thrombosis (8.3% vs 0, P=0.016) , and renal function deterioration (20.8% vs 3.9%, P=0.030) in patients with renal insufficiency was higher than that in patients with normal renal function. Conclusion: The VRD regimen has a significant effect on newly diagnosed MM, does not affect the hematopoietic stem cell collection, and has controllable adverse events; however, the incidence of adverse events was higher in patients with renal insufficiency.

PMID:36709150 | DOI:10.3760/cma.j.issn.0253-2727.2022.08.007

Zhonghua Xue Ye Xue Za Zhi. 2022 Aug 14;43(8):636-643. doi: 10.3760/cma.j.issn.0253-2727.2022.08.004.

ABSTRACT

Objective: This study aimed to observe whether the treatment-free remission (TFR) of second-generation tyrosine kinase inhibitors (TKI) in chronic myeloid leukemia (CML) is better than imatinib (IM) . Methods: The clinical data of 274 CML patients who discontinued treatment and with complete clinical data were retrospectively studied from June 2013 to March 2021. Using both univariate and multivariate Cox proportional hazards regression models, risk factors influencing TFR outcomes after drug withdrawal in CML patients were assessed. Results: A total of 274 patients were enrolled, 140 patients were women (51.1%) , with a median age of 48 (9-84) years at the time of TKI discontinuation. Prior to TKI discontinuation, 172 (62.8%) patients were treated with IM, and 102 (37.2%) had received second-generation TKI treatment, including 73 patients who had shifted from IM to a second-generation TKI and 29 patients who used second-generation TKI as the first-line treatment. The rationale for converting to a second-generation TKI are as follows: 37 patients aimed deep molecular response (DMR) to achieve TFR, seven patients changed due to IM intolerance, and 29 patients changed because of failure to achieve the optimal treatment response. The use of the last type of TKI included 96 patients (94.1%) with nilotinib, three patients (2.9%) with dasatinib, and two patients (2%) with flumatinib, including one patient who changed to IM due to second-generation TKI intolerance. No statistical differences were found in the median age at diagnosis and TKI discontinuation, sex, Sokal score, IFN treatment before TKI, median time of TKI treatment to achieve DMR, and the reasons for TKI discontinuation between the second TKI and IM (P>0.05) .The median cumulative treatment time of TKI (71.5 months vs 88 months, P<0.001) , the last TKI median treatment time (60 months vs 88 months, P<0.001) , and the median duration of DMR (58 months vs 66 months, P=0.002) were significantly shorter in the second-generation TKI compared with IM. In the median follow-up of 22 (6-118) months after TKI discontinuation, 88 patients (32.1%) had lost their MMR at a median of 6 (1-91) months; of the 53 patients (60.2%) who lost MMR within 6 months, the overall TFR rate was 67.9%, and the cumulative TFR rates at 12 and 24 months were 70.5% and 67.5%, respectively. Withdrawal syndrome occurred in 26 patients (9.5%) . For patients who restarted TKI treatment, 72 patients (83.7%) achieved DMR again at a median treatment of 4 (1 to 18) months. The univariate analysis showed that the TFR rate of patients treated with second-generation TKI was significantly higher than those who were treated with IM (77.5% vs 62.2%, P=0.041) . A further subgroup analysis found that the TFR rate of the second-generation TKI patients was significantly higher than those treated with IM (80.8% vs 62.2%, P=0.026) . No significant difference was found in the second-generation TKI used as the first line treatment compared with those who were treated with IM (69.0% vs 62.2%, P=0.599) . The multivariate analysis results showed that second-generation TKI treatment was an independent prognostic factor affecting TFR in patients who discontinued TKI (RR=1.827, 95%CI 1.015-3.288, P=0.044) . Conclusion: In the clinical setting, more CML patients rapidly achieved TFR using second-generation TKI than IM treatment.

PMID:36709147 | DOI:10.3760/cma.j.issn.0253-2727.2022.08.004

Zhonghua Xue Ye Xue Za Zhi. 2022 Jul 14;43(7):562-567. doi: 10.3760/cma.j.issn.0253-2727.2022.07.006.

ABSTRACT

Objective: The study aims to establish a perfect BCR-ABL (P210) internal quality control system and ensure the long-term stability and comparability of the detection results between laboratories and to popularize and apply it in the three hospitals. Methods: The Qilu Hospital of Shandong University (H1) prepared a set of the BCR-ABL (P210) quality control substances to establish and improve internal quality control system. We went to other three participating hospitals (H2, H3, and H4) to inspect quality control before the measurement. In addition, we mailed 25 sets of quality control substances to each of the hospital for detection. The slope and intercept of the standard curve of each hospital and the detection results were analyzed and statistically judged using the Levey-Jennings quality control chart combined with the Westgard multirule theory. Then, we made a quality control evaluation. Results: ①An internal quality control system for the BCR-ABL (P210) transcript levels monitoring was successfully established for the quality inspection before the measurement, statistical judgment during the measurement, and evaluation after the measurement. ② Both the slope and intercept of the standard curve of the four hospitals was under control. ③The multicenter quality control substance judgment results were as follows: for H1 hospital, two times of “1(2s)” warning were found in the middle-level quality control substance, which was judged as being under control; for H2 hospital, one time of “1(2s)” warning was found for each quality control substance, which was judged as being “2(2s)” out of control; for H3 hospital, its high-level quality control substance violated the “1(3s)” rule, and low-level quality control substance appeared “1(2s)” warning, which was judged as “1(3s)” out of control; and all quality control substances were under control in H4 hospital. ④The quality control evaluation and correction were as follows: two hospitals were under control, and the other two hospitals had an “out of control.” We found out the reason for the out of control and corrected them. ⑤The comparisons of the original values of the multicenter quality control substance were as follows: there were statistical differences in the results of high-level quality control substance among the four hospitals, and no significant difference was found in the results of the medium-level and low-level quality control substance. ⑥The comparisons of the IS values of the multicenter quality control substance were as follows: the IS values of the three quality control substance in H2 and H3 hospitals were significantly higher than those of H1 hospital, and H2 hospital was significantly higher than H3 hospital. Conclusion: A perfect and stable internal quality control system for the BCR-ABL (P210) transcripts has been established, which can effectively ensure the accuracy and stability of the clinical detection results. This internal quality control system has been successfully popularized and applied in other hospitals.

PMID:36709133 | DOI:10.3760/cma.j.issn.0253-2727.2022.07.006

Zhonghua Zhong Liu Za Zhi. 2023 Jan 23;45(1):56-63. doi: 10.3760/cma.j.cn112152-20200623-00588.

ABSTRACT

Objective: To investigate the effect of long non-coding RNA urothelial carcinoma-associated 1 (UCA1) gene on the proliferation, migration, apoptosis and immune escape of endometrial cancer cells and its molecular mechanism. Methods: Endometrial cancer tissues and adjacent normal tissues of patients with endometrioid adenocarcinoma who underwent total or partial hysterectomy in Henan Provincial People’s Hospital from 2017 to 2019 were collected. The expressions of UCA1 and miR-204-5p were detected by real-time fluorescence quantitative polymerase chain reaction (RT-qPCR), and the cell proliferation, migration and apoptosis were detected by cell counting kit 8 (CCK8) method, Transwell method, flow cytometry, and dual-luciferase reporter assay was used to explore the target relationship between UCA1 and miR-204-5p. HEC-1A-sh-NC or HEC-1A-sh-UCA1 cells were co-cultured with peripheral blood mononuclear cells (PBMC) or cytokine-induced killer cells in vitro to explore the role of UCA1 in immune escape. Results: The expression level of UCA1 in endometrial cancer tissue (17.08±0.84) was higher than that in adjacent normal endometrial tissue (3.00±0.37), and the expression level of miR-204-5p (0.98±0.16) was lower than that in adjacent normal endometrial tissue (2.00±0.20, P<0.05). Pearson correlation analysis showed that the expression of miR-204-5p was negatively correlated with the expression of UCA1 (r=-0.330, P=0.030). The expressions of UCA1 and miR-204-5p were associated with the International Federation of Gynecology and Obstetrics stage of endometrial cancer, lymph node metastasis and vascular invasion (P<0.05). The relative ratio of absorbance (0.58±0.11) and the number of cell migration [(199.68±18.44)] in the sh-UCA1 group were lower than those in the sh-NC group (1.24±0.17 and 374.76±24.83), respectively. The apoptosis rate of sh-UCA1 group [(28.64±7.80)%] was higher than that of sh-NC group [(14.27±4.38)%, P<0.05]. After different ratios of effector cells and target cells were cultured, the cell survival rate of HEC-1A-sh-UCA1 group was lower than that of HEC-1A-sh-NC group, and the difference was statistically significant (P<0.05). UCA1 had a binding site for miR-204-5p. The relative ratio of absorbance (1.74±0.08) and the number of cell migration (426.00±18.00) cells in the UCA1+ anti-miR-204-5p group were higher than those in the control group [1.00±0.03 and (284.00±8.00) cells, respectively]. The apoptosis rate of UCA1+ anti-miR-204-5p group [(5.42±0.93)%] was lower than that of control group [(14.82±1.48)%, P<0.05]. HEC-1A-sh-UCA1 cells could induce higher interferon gamma (IFN-γ) expression when co-cultured with PBMC, and the levels of IFN-γ expression in PHA group and PHA+ pre-miR-204-5p group cells were 2.42±0.49 and 1.88±0.26, which were higher than that in the PHA+ pre-NC group (0.85±0.10, P<0.05). When co-cultured with cytokine-induced killer cells (different ratios) in vitro, the HEC-1A-sh-UCA1 group and the HEC-1A-pre-miR-204-5p group had lower survival rates than that in the HEC-1A-pre-miR-204-5p group. In the HEC-1A-pre-NC group, the differences were statistically significant (P<0.05). Conclusion: UCA1/miR-204-5p may play an important role in human endometrial cancer.

PMID:36709121 | DOI:10.3760/cma.j.cn112152-20200623-00588