Tag: statistics

J Manipulative Physiol Ther. 2023 Jul 7:S0161-4754(23)00023-4. doi: 10.1016/j.jmpt.2023.05.005. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to assess the effect of adding core stability to usual care for pregnant women with lumbar and pelvic girdle (LPG) pain.

METHODS: This was a repeated-measures design randomized controlled trial with blinded outcome assessors. Thirty-five pregnant women with LPG pain were recruited from prenatal health care providers. They were allocated to 2 study groups to receive either usual prenatal care (control group, n = 17) or usual care with core stability exercises focusing on the pelvic floor muscles and deep abdominal muscles (exercise group, n = 18) for 10 weeks. The visual analog scale, score on the Oswestry Disability Index, and the World Health Organization’s Quality of Life Brief Version (WHOQOL-BREF) were evaluated with analysis of variance at pre-intervention, post-intervention, at the end of pregnancy, and 6 weeks after childbirth.

RESULTS: There was a statistically significant interaction of group and time for all outcome measures except for the Social category (P = .18) in the WHOQOL-BREF questionnaire. The analysis of the group within time showed that mean scores in the exercise group were substantially improved at the post-intervention, end of pregnancy, and 6-week follow-up evaluation, except in the Environment category (end of pregnancy: P = .36; 6-week follow-up: P = .75) in the WHOQOL-BREF questionnaire.

CONCLUSION: The results of this study indicate that the addition of core stability exercises was more effective than the usual care alone in pain relief, improving disability, and quality of life of pregnant women with LPG pain.

PMID:37422748 | DOI:10.1016/j.jmpt.2023.05.005

Mayo Clin Proc. 2023 Jul 6:S0025-6196(23)00193-3. doi: 10.1016/j.mayocp.2023.03.024. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the association of early-life tobacco smoke exposure, especially interacting with cancer genetic variants, with adult cancer.

PARTICIPANTS AND METHODS: We examined the associations of in utero tobacco smoke exposure, age of smoking initiation, and their interaction with genetic risk levels with cancer incidence in 393,081 participants from the UK Biobank. Information on tobacco exposure was obtained by self-reported questionnaires. A cancer polygenic risk score was constructed by weighting and integrating 702 genome-wide association studies-identified risk variants. Cox proportional hazards regression models were used to calculate hazard ratios (HRs) for overall cancer and organ-specific cancer incidence.

RESULTS: During 11.8 years of follow-up, 23,450 (5.97%) and 23,413 (6.03%) incident cancers were included in the analyses of in utero exposure and age of smoking initiation, respectively. The HR (95% CI) for incident cancer in participants with in utero exposure to tobacco smoke was 1.04 (1.01-1.07) for overall cancer, 1.59 (1.44-1.75) for respiratory cancer, and 1.09 (1.03-1.17) for gastrointestinal cancer. The relative risk of incident cancer increased with earlier smoking initiation (P_trend<.001), with the HR (95% CI) of 1.44 (1.36-1.51) for overall cancer, 13.28 (11.39-15.48) for respiratory cancer, and 1.72 (1.54-1.91) for gastrointestinal cancer in smokers with initiation in childhood compared with never smokers. Importantly, a positive additive interaction between age of smoking initiation and genetic risk was observed for overall cancer (P_additive=.04) and respiratory cancer (P_additive=.003) incidence.

CONCLUSION: In utero exposure and earlier smoking initiation are associated with overall and organ-specific cancer, and age of smoking initiation interaction with genetic risk is associated with respiratory cancer.

PMID:37422733 | DOI:10.1016/j.mayocp.2023.03.024

Sleep. 2023 Jul 9:zsad177. doi: 10.1093/sleep/zsad177. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Sleep-related adverse effects during acute treatment with antidepressants undermine compliance and impede remission. We aimed to address subtypes of sleep-related adverse effects and depict the relationship between dose and sleep-related adverse events.

METHODS: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science for double-blind randomized controlled trials of depression published before April 30th, 2023. Eligible studies reporting sleep-related adverse effects during short-term monotherapy were included. The odds ratios (ORs) for sleep-related adverse effects were addressed with network meta-analysis. A Bayesian approach was used to depict the dose-effect relationship. Heterogeneity among studies was assessed using the τ 2 and I 2 statistics. Sensitivity analyses were performed without studies featured high risk of bias.

RESULTS: Studies with 64,696 patients were examined from 216 trials. Comparing to placebo, 13 antidepressants showed higher ORs for somnolence, of which fluvoxamine (OR=6.32; 95%CI: 3.56-11.21) ranked the top. Eleven had higher risks for insomnia, reboxetine ranked the top (OR=3.47; 95%CI: 2.77-4.36). The dose-effect relationships curves between somnolence or insomnia and dose included linear shape, inverted U-shape and other shapes. There was no significant heterogeneity among individual studies. The quality of evidence for results in network meta-analyses was rated as very low to moderate by GRADE.

CONCLUSIONS: Most antidepressants had higher risks for insomnia or somnolence than placebo. The diverse relationship curves between somnolence or insomnia and dose of antidepressants can guide clinicians to adjust the doses. These findings suggest clinician pay more attention to sleep-related adverse effects during acute treatment with antidepressants.

PMID:37422714 | DOI:10.1093/sleep/zsad177

J Comput Assist Tomogr. 2023 Jul 7. doi: 10.1097/RCT.0000000000001511. Online ahead of print.

ABSTRACT

OBJECTIVE: In liver transplantation, chronic rejection is still poorly studied. This study aimed to investigate the role of imaging in its recognition.

METHODS: This study is a retrospective observational case-control series. Patients with histologic diagnosis of chronic liver transplant rejection were selected; the last imaging examination (computed tomography or magnetic resonance imaging) before the diagnosis was evaluated. At least 3 controls were selected for each case; radiological signs indicative of altered liver function were analyzed. χ2 Test with Yates correction was used to compare the rates of radiologic signs in the case and control groups, also considering whether patients suffered chronic rejection within or after 12 months. Statistical significance was set at P < 0.050.

RESULTS: A total of 118 patients were included in the study (27 in the case group and 91 in the control group). Periportal edema was appreciable in 19 of 27 cases (70%) and in 6 of 91 controls (4%) (P < 0.001); ascites and hepatomegaly were present in 14 of 27 cases (52%) and 12 of 27 cases (44%), respectively, and in 1 of 91 controls (1%) (P < 0.001); splenomegaly was present in 13 of 27 cases (48%) and in 8 of 91 controls (10%) (P < 0.001); and biliary tract dilatation was present in 13 of 27 cases (48%) and in 11 of 91 patients controls (5%) (P < 0.001). In the controls, periportal edema was significantly less frequent beyond 12 months after transplant (1% vs 11%; P = 0.020); the other signs after 12 months were not significant.

CONCLUSIONS: The identification of periportal edema, biliary dilatation, ascites, and hepatosplenomegaly can serve as potential warning signs of ongoing chronic liver rejection. It is especially important to investigate periportal edema if it is present 1 year or more after orthotopic liver transplantation.

PMID:37422693 | DOI:10.1097/RCT.0000000000001511

Clin Pharmacol Ther. 2023 Jul 8. doi: 10.1002/cpt.2982. Online ahead of print.

ABSTRACT

Oral azacitidine (Oral-AZA) maintenance is approved for adults with acute myeloid leukemia (AML) in remission post-intensive chemotherapy, not proceeding to hematopoietic stem cell transplantation. This study aimed to develop a population pharmacokinetic (PopPK) model to characterize Oral-AZA concentration-time profiles in patients with AML, myelodysplastic syndrome, or chronic myelomonocytic leukemia. PopPK-estimated exposure parameters were used to evaluate exposure-response relationships in the phase 3 QUAZAR AML-001 study. The PopPK dataset comprised 286 patients with 1933 evaluable Oral-AZA concentration records. The final PopPK model was a one-compartment model with first-order absorption incorporating an absorption lag time and first-order elimination. Regression analyses identified two Oral-AZA exposure parameters (area under the plasma concentration-time curve at steady state [AUC_ss ]; maximum plasma concentration [C_max ]) as statistically significant predictors for relapse-free survival (HR=0.521, p<0.001; HR=0.630, p=0.013; respectively), and AUC_ss as a significant predictor for overall survival (HR=0.673, p=0.042). The probability of Grade ≥3 neutropenia was significantly increased with increases in AUC_ss (OR=5.71, 95% CI=2.73-12.62, p<0.001), cumulative AUC through cycles 1 to 6 (OR=2.71, 95% CI=1.76-4.44, p<0.001), and C_max at steady state (OR=2.38, 95% CI=1.23-4.76, p=0.012). A decreasing trend was identified between AUC_ss and relapse-related schedule extensions, versus an increasing trend between AUC_ss and event-related dose reductions. As the majority (56.8%) of patients required no dose modifications, and the proportions requiring schedule extension (19.4%) or dose reduction (22.9%) were almost equal, Oral-AZA 300 mg once daily for 14 days is the optimal dosing schedule balancing survival benefit and safety risk.

PMID:37422689 | DOI:10.1002/cpt.2982

Ital J Pediatr. 2023 Jul 8;49(1):80. doi: 10.1186/s13052-023-01491-y.

ABSTRACT

BACKGROUND: To examine the clinical impact of bronchoscope alveolar lavage (BAL) combination with budesonide, ambroxol + budesonide, or acetylcysteine + budesonide in the treatment of refractory Mycoplasma pneumoniae pneumonia (RMPP).

METHODS: Eighty-two RMPP patients admitted to Pediatrics at The First People’s Hospital of Zhengzhou were retrospectively evaluated between August 2016 and August 2019. All patients were administered BAL in addition to intravenous Azithromycin, expectoration, and nebulizer inhalation. The medications added to the BLA separated the patients into the Budesonide group, Ambroxol + budesonide group, and acetylcysteine + budesonide group. Analyzed were the variations in laboratory examination indices, improvement in lung imaging, overall effective rate, and adverse responses in the three groups.

RESULTS: The laboratory test indices of patients in all three groups improved significantly relative to pre-treatment levels, and the results were statistically significant. After therapy, there were no significant differences between the three groups in terms of white blood cell (WBC), C-reactive protein (CRP), or erythrocyte sedimentation rate (ESR). Serum lactate dehydrogenase (LDH) and serum ferritin (SF) varied significantly across the three groups (P < 0.05). In the acetylcysteine + budesonide group, the absorption rate of lung imaging lesions and clinical efficacy were superior to those of the other two groups. There were no significant differences between the three groups in the occurrence of adverse events (P > 0.05).

CONCLUSIONS: BLA-coupled acetylcysteine + budesonide was superior to the other two groups in enhancing the effectiveness of RMPP in children, which might increase lung opacity absorption and minimize lung inflammation.

PMID:37422684 | DOI:10.1186/s13052-023-01491-y

BMC Health Serv Res. 2023 Jul 8;23(1):737. doi: 10.1186/s12913-023-09758-0.

ABSTRACT

OBJECTIVES: Vaccination is an important part of public health services. We aim to assess the efficiency of vaccination services in Beijing, the capital of China, and to further study the influencing factors of efficiency.

METHODS: Using the immunization service data of Beijing, China in 2020, we firstly developed a data envelopment analysis (DEA) model to calculate the score of vaccination efficiency. Secondly, we used DEA model scenario simulations with different combinations of input-output factors to derive the magnitude of the effect of each input factor on the efficiency. Finally, combined with the data from the Beijing Regional Statistical Yearbook 2021, we developed the Tobit model to examine the effect of external social environmental factors on efficiency.

RESULTS: The average scores of efficiency of POVs (Point of Vaccination) in different areas of Beijing vary greatly. Different input factors had different degrees of positive effects on the efficiency score. In addition, the number of populations served by POV was positively associated with efficiency, the GDP and financial allocation of the POVs’ district was also positively associated with efficiency score, while the total dependency ratio of the POVs’ district was negatively associated with efficiency score.

CONCLUSION: The efficiency of vaccination services varied considerably across POVs. Constrained by limited resources, efficiency scores can be increased by increasing input factors that have a larger impact on efficiency score and reducing those that have a smaller impact on efficiency. In addition, the social environment should be considered in allocating vaccination resources, and more resources should be invested in areas with low levels of economic development, low financial allocation, and high population.

PMID:37422663 | DOI:10.1186/s12913-023-09758-0

Clin Pharmacol Ther. 2023 Jul 8. doi: 10.1002/cpt.2994. Online ahead of print.

ABSTRACT

Hybrid designs with both randomised arms and an external control cohort preserve key features of randomisation and utilise external information to augment clinical trials. In this study, we propose to leverage high-quality, patient-level concurrent registries to enhance clinical trials and illustrate the impact on trial design for amyotrophic lateral sclerosis (ALS). The proposed methodology was evaluated in a randomised, placebo-controlled clinical trial. We used patient-level information from a well-defined, population-based registry, that was running parallel to the randomised clinical trial, to identify concurrently non-participating, eligible patients who could be matched with trial participants, and integrate them into the statistical analysis. We assessed the impact of the addition of the external controls on the treatment effect estimate, precision, and time to reach a conclusion. During the runtime of the trial, a total of 1,141 registry patients were alive; 473 (41.5%) of them fulfilled the eligibility criteria and 133 (11.7%) were enrolled in the study. A matched control population could be identified among the non-participating patients. Augmenting the randomised controls with matched external controls could have avoided unnecessary randomisation of 17 patients (-12.8%) as well as reducing the study duration from 30.1 months to 22.6 months (-25.0%). Matching eligible external controls from a different calendar period led to bias in the treatment effect estimate. Hybrid trial designs utilising a concurrent registry with rigorous matching can minimise bias due to a mismatch in calendar time and differences in standard of care, and may accelerate the development of new treatments.

PMID:37422655 | DOI:10.1002/cpt.2994

BMC Musculoskelet Disord. 2023 Jul 8;24(1):557. doi: 10.1186/s12891-023-06681-7.

ABSTRACT

PURPOSE: To investigate the safety and accuracy of applying a new self-guided pedicle tap to assist pedicle screw placement.

METHODS: A new self-guided pedicle tap was developed based on the anatomical and biomechanical characteristics of the pedicle. Eight adult spine specimens, four males and four females, were selected and tapped on the left and right sides of each pair of T1-L5 segments using conventional taps (control group) and new self-guided pedicle taps (experimental group), respectively, and pedicle screws were inserted. The screw placement time of the two groups were recorded and compared using a stopwatch. The safety and accuracy of screw placement were observed by CT scanning of the spine specimens and their imaging results were graded according to the Heary grading criteria.

RESULTS: Screw placement time of the experimental group were (5. 73 ± 1. 18) min in thoracic vertebrae and (5. 09 ± 1. 31) min in lumbar vertebrae respectively. Screw placement time of the control group were respectively (6. 02 ± 1. 54) min in thoracic vertebrae and (5.51 ± 1.42) min in lumbar vertebrae. The difference between the two groups was not statistically significant (P > 0. 05). The Heary grading of pedicle screws showed 112 (82.35%) Heary grade I screws and 126 (92.65%) Heary grade I + II screws in the experimental group, while 96 (70.59%) Heary grade I screws and 112 (82.35%) Heary grade I + II screws in the control group.The difference between the two groups was statistically significant (P < 0.05).

CONCLUSION: The new self-guided pedicle tap can safely and accurately place thoracic and lumbar pedicle screws with low-cost and convenient procedure,which indicates a good clinical application value.

PMID:37422653 | DOI:10.1186/s12891-023-06681-7

BMC Womens Health. 2023 Jul 8;23(1):364. doi: 10.1186/s12905-023-02510-0.

ABSTRACT

BACKGROUND: To explore the pathogen distribution in Chinese females with vaginitis.

METHODS: This retrospective study included Chinese females with vaginitis admitted at the outpatient department of the Gynecology Clinic of the Second Affiliated Hospital of Kunming Medical University between January 2013 and June 2013. Data on the vaginal pathogens and inflammation were analyzed.

RESULTS: The vaginal secretions from 15,601 gynecologic outpatients were abnormal, including 8547 (54.78%) with vaginal infection and 7054 (45.22%) without. In patients with vaginal infections, a single infection was observed in 69.72% (5959/8547) of them, and mixed infection was observed in 30.28% (2588/8547). The differences in age and inflammation grade between the infection and no-infection groups were statistically significant (all P < 0.001). In addition, multiple types of vaginitis could be diagnosed in patients with mixed infections.

CONCLUSIONS: About half of the Chinese women with abnormal vaginal secretions are positive for pathogens in the study period. Patients’ age and inflammation grade are associated with co-infection. From the public health perspective, this study suggests that the importance of vaginal hygiene should be enforced in Chinese women.

PMID:37422650 | DOI:10.1186/s12905-023-02510-0