Tag: statistics

Medicine (Baltimore). 2022 Jan 21;101(3):e28615. doi: 10.1097/MD.0000000000028615.

ABSTRACT

BACKGROUND: Patient-controlled analgesia (PCA) is an effective method of postoperative pain, there have been many studies performed that have compared the efficacy of hydromorphone with continuous sufentanil. The purpose of this systematic review is to compare the efficacy and safety of hydromorphone and sufentanil.

METHODS: Seven databases were searched for controlled trials to compare the efficacy and safety of hydromorphone and sufentanil. After selecting the studies, extracting the data, and assessing study quality, the meta-analysis was performed on several of the studies with RevMan 5.3.

RESULTS: Thirteen studies comprised of 812 patients were found. The pain intensity of the hydromorphone group was significantly lower than that of the sufentanil group at 12 hours. With no statistical difference at 24 to 48 hours (MD12 = -1.52, 95% CI [-2.13, -1.97], P <.05). The sedation intensity of the hydromorphone group at 12, 24, and 48 hours were lower than those of the sufentanil group, with no statistical difference (MD12 = -0.03, 95% CI [-0.18, 0.12], P > .05; MD24 = -0.20, 95% CI [-0.42, 0.03], P > .05; MD48 = -0.03, 95% CI [-0.18, 0.11)], P > .05). The PCA requests in the hydromorphone group were less than that in the sufentanil group, and there was no significant difference (RR = -0.20, 95% CI [-1.93,1.53], P > .05). The incidence of adverse events in the hydromorphone group was less than that in the sufentanil group, and there was a statistical difference: (RR = 0.61, 95% CI [0.47,0.79], P < .05).

CONCLUSION: Compared with sufentanil, PCA with hydromorphone was more effective in relieving pain and PCA requests 12, 24, and 48 hours after operation, and significantly reduced the incidence of adverse events, but it did not have an advantage in sedation intensity.

PMID:35060534 | DOI:10.1097/MD.0000000000028615

Medicine (Baltimore). 2022 Jan 21;101(3):e28595. doi: 10.1097/MD.0000000000028595.

ABSTRACT

BACKGROUND: Knee osteoarthritis (KOA) is a common disease with the high occurrence in the world. The symptoms of pain and dysfunction decrease quality of life in KOA patients. Several studies reported traditional Chinese manual therapy showed beneficial effects in improving pain and dysfunction of patient with KOA, but most previous reviews did not focus on the effects on quality life of traditional Chinese manual therapy for KOA. However, better quality of life is important for patients suffering KOA. Therefore, the current review and meta-analysis will be conducted to assess the effects on clinical symptoms and quality of life of traditional Chinese manual therapy for KOA.

METHODS: Eight electronic databases including PubMed, Embase, the Cochrane Library, Web of Science, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Data, and Chinese Scientific Journal Database will be searched from the beginning to December 2021. Two reviewers will independently select included studies and extract data. Heterogeneity will be evaluated by I2 statistic before the data synthesis. Subgroup analysis will be performed by duration of KOA, different types of traditional Chinese manual therapy, different outcomes, and different intervention time. The primary outcome is quality of life in KOA patients, and the secondary outcomes include pain and dysfunction due to KOA. Rev Man 5.3 software will be used for meta-analysis.

RESULTS: The results of this review will be reported in a peer-reviewed journal.

CONCLUSION: The results of this review will provide reliable evidence for the effects on quality of life and clinical symptoms of traditional Chinese manual therapy for KOA.

INPLASY REGISTRATION NUMBER: INPLASY2021120043.

PMID:35060525 | DOI:10.1097/MD.0000000000028595

Medicine (Baltimore). 2022 Jan 21;101(3):e28527. doi: 10.1097/MD.0000000000028527.

ABSTRACT

BACKGROUND: More than 80% of the population suffer from low back pain at some time during their lives. An orthopedic device (LSM-01) will be used to alleviate back pain caused by muscle tension. LSM-01, which has a rotating roller, stimulates meridian-muscles around the governor vessel, bladder meridian, and gall bladder meridian.

METHODS: This study will be a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Subjects will be randomly allocated to the treatment group (LSM-01) or the control group (sham device). The duration of the clinical trial will be 2 weeks. The primary outcomes will be measured using the visual analog scale; the secondary outcomes will include pressure pain threshold, Oswestry Disability Index, and Patient Global Impression of Change. Statistical analysis will be performed for the full study population. Analysis of covariance will be conducted to identify differences in pain before and after the application of the device.

DISCUSSION: This clinical trial will evaluate the safety and efficacy of the LSM-01 device. As a pilot study, this investigation includes a limited number of subjects. The results of this pilot trial will form a basis for a large-scale clinical trial, which will be conducted in the future.

CLINICAL TRIAL REGISTRATION: This study protocol is registered with the Clinical Research Information Service (CRIS) of Korea. Clinical trial registration number: CRIS-KCT0006425. Registered: October 5, 2021; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=L&pageSize=10&page=undefined&seq=20056&status=5&seq_group=20056.

PMID:35060507 | DOI:10.1097/MD.0000000000028527

Medicine (Baltimore). 2022 Jan 21;101(3):e28539. doi: 10.1097/MD.0000000000028539.

ABSTRACT

Primary splenic cancers represent a small number of cancer cases and studies on its clinicopathological features and outcomes are limited. Splenic lymphomas and primary splenic angiosarcoma (PSA) are the 2 most common histological types of splenic cancers. This population-based study aimed to investigate the clinical characteristics and survival outcomes of patients with splenic lymphomas or PSA.Patients diagnosed with splenic lymphomas or PSA between 2000 and 2015 were identified from the Surveillance Epidemiology and End Results database of the National Cancer Institutes. Overall survival (OS) and cancer-specific survival (CSS) rates were calculated using the Kaplan-Meier method. A Cox proportional hazard models were used to identify independent predictors of cancer-specific mortality.A total of 700 patients with splenic lymphoma and 48 patients with PSA were included in this study. The median age of patients with splenic lymphoma was 65 years and 57 years for patients with PSA. For patients with splenic lymphoma, the most prevalent histological subtypes were splenic marginal zone lymphoma and diffuse large B-cell lymphoma. A total of 52.6% of the cases had stage IV disease based on the Ann Arbor staging system. Five-year OS and CSS were 76.9% and 83.4%, respectively. Multivariate analysis revealed that independent predictors of splenic lymphoma CSS included race, stage, chemotherapy, and histological subtype. However, a much shorter OS time was seen in the PSA cohort which had a 5-year OS of 11.8%, a median OS of 10.0 months and the 5-year CSS of 12.4%. Chemotherapy was correlated with better outcomes in patients with PSA. However, the survival benefits of surgery for splenic cancer were not statistically significant in our study.The current study is the largest cohort of primary splenic cancer presented in literature based on the Surveillance Epidemiology and End Results database and our large series describe the characteristics and survival outcomes of such rare diseases which may provide reliable information for further studies and clinicians.

PMID:35060511 | DOI:10.1097/MD.0000000000028539

Medicine (Baltimore). 2022 Jan 21;101(3):e27770. doi: 10.1097/MD.0000000000027770.

ABSTRACT

BACKGROUND: Type 2 diabetes is an independent risk factor for stroke. The main role of the current study is to study the mechanism of stroke induced by diabetes, but there is no systematic summary of daily management and stroke prevention for patients with type 2 diabetes. In order to provide a more detailed stroke prevention program for patients with type 2 diabetes, we included in the study and looked forward to analyzing the risk factors that were more in line with the clinical characteristics of type 2 diabetes.

METHODS: We will search the following Chinese and English databases: PubMed, Web of science, Cochrane Library, Medline, and China National Knowledge Infrastructure database. All of the above electronic databases will be searched from inception to June 30, 2021. In addition, we will manually search for conference papers, ongoing experiments, and internal reports to supplement the studies retrieved via electronic search. We will use the STATA 16.0 provided by Cochrane Collaboration Network for statistical analysis.

RESULTS: The study will prove a collective view on the relationship between related factors and stroke in the type 2 diabetes population.

CONCLUSION: We plan to submit this systematic review to a peer-reviewed journal.INPLASY registration number: INPLASY2021100046.

PMID:35060494 | DOI:10.1097/MD.0000000000027770

Medicine (Baltimore). 2022 Jan 21;101(3):e28128. doi: 10.1097/MD.0000000000028128.

ABSTRACT

Ischial tuberosity cyst is a common disease, and the conventional incision procedure is associated with several disadvantages, leading to unsatisfactory therapeutic outcomes. The aim of the study was to evaluate the clinical outcomes of arthroscopic treatment for ischial tuberosity cyst and compared it with conventional incision surgery.The clinical data of 57 patients with ischial tuberosity cyst from May 2016 to September 2018 were retrospectively analyzed. According to the inclusion and exclusion criteria, a total of 49 patients were included. Of these patients, 24 patients received arthroscopic procedure (N = 24) and 25 patients received conventional incision procedure (N = 25). The operation time, intraoperative blood loss, postoperative drainage, postoperative hospital stay, and postoperative complications were compared between the 2 groups. Visual analogue scale scores was used to evaluate pain at 1 day, 1 week, and 1 month after the surgery.All 49 patients were followed up for (11.3 ± 3.3) months. All patients in the arthroscopy group achieved phase I healing while 3 patients in conventional incision group developed complications. The operation time, intraoperative blood loss, postoperative drainage, and hospital stay in the arthroscopy group were (54.7 ± 7.7) minutes, (20.8 ± 3.5) mL, (20.3 ± 5.6) mL, and (2.8 ± 0.6) days, and were significantly better than those of (71.8 ± 8.8) minutes, (67.3 ± 12.0) mL, (103.6 ± 20.3) mL, and (7.8 ± 2.9) days in the conventional incision group, respectively. In the arthroscopy group, the visual analogue scale scores at 1 day, 1 week, and 1 month after the surgery [(2.6 ± 0.7), (0.5 ± 0.6), (0.3 ± 0.5) points] were significantly lower than those in the conventional incision group [(6.0 ± 0.7), (3.0 ± 1.0), and (1.1 ± 1.0) points], and the differences were statistically significant (P < .05). Finally, no significant difference was observed in the incidence of postoperative complications between the 2 groups (P > .05).In the treatment of ischial tuberosity cysts, arthroscopy has advantages of minimal invasion, less blood loss during perioperative period, milder postoperative pain, and rapid recovery when compared with conventional incision surgery.

PMID:35060495 | DOI:10.1097/MD.0000000000028128

Elife. 2022 Jan 21;11:e70393. doi: 10.7554/eLife.70393.

ABSTRACT

BACKGROUND: In a phase 3 trial in African infants and children, the RTS,S/AS01 vaccine (GSK) showed moderate efficacy against clinical malaria. We sought to further understand RTS,S/AS01-induced immune responses associated with vaccine protection.

METHODS: Applying the blood transcriptional module (BTM) framework, we characterized the transcriptomic response to RTS,S/AS01 vaccination in antigen-stimulated (and vehicle control) peripheral blood mononuclear cells sampled from a subset of trial participants at baseline and month 3 (1-month post-third dose). Using a matched case-control study design, we evaluated which of these ‘RTS,S/AS01 signature BTMs’ associated with malaria case status in RTS,S/AS01 vaccinees. Antigen-specific T-cell responses were analyzed by flow cytometry. We also performed a cross-study correlates analysis where we assessed the generalizability of our findings across three controlled human malaria infection studies of healthy, malaria-naive adult RTS,S/AS01 recipients.

RESULTS: RTS,S/AS01 vaccination was associated with downregulation of B-cell and monocyte-related BTMs and upregulation of T-cell-related BTMs, as well as higher month 3 (vs. baseline) circumsporozoite protein-specific CD4⁺ T-cell responses. There were few RTS,S/AS01-associated BTMs whose month 3 levels correlated with malaria risk. In contrast, baseline levels of BTMs associated with dendritic cells and with monocytes (among others) correlated with malaria risk. The baseline dendritic cell- and monocyte-related BTM correlations with malaria risk appeared to generalize to healthy, malaria-naive adults.

CONCLUSIONS: A prevaccination transcriptomic signature associates with malaria in RTS,S/AS01-vaccinated African children, and elements of this signature may be broadly generalizable. The consistent presence of monocyte-related modules suggests that certain monocyte subsets may inhibit protective RTS,S/AS01-induced responses.

FUNDING: Funding was obtained from the NIH-NIAID (R01AI095789), NIH-NIAID (U19AI128914), PATH Malaria Vaccine Initiative (MVI), and Ministerio de Economía y Competitividad (Instituto de Salud Carlos III, PI11/00423 and PI14/01422). The RNA-seq project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under grant number U19AI110818 to the Broad Institute. This study was also supported by the Vaccine Statistical Support (Bill and Melinda Gates Foundation award INV-008576/OPP1154739 to R.G.). C.D. was the recipient of a Ramon y Cajal Contract from the Ministerio de Economía y Competitividad (RYC-2008-02631). G.M. was the recipient of a Sara Borrell-ISCIII fellowship (CD010/00156) and work was performed with the support of Department of Health, Catalan Government grant (SLT006/17/00109). This research is part of the ISGlobal’s Program on the Molecular Mechanisms of Malaria which is partially supported by the Fundación Ramón Areces and we acknowledge support from the Spanish Ministry of Science and Innovation through the ‘Centro de Excelencia Severo Ochoa 2019-2023’ Program (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Program.

PMID:35060479 | DOI:10.7554/eLife.70393

J Asthma. 2022 Jan 21:1-13. doi: 10.1080/02770903.2022.2032136. Online ahead of print.

ABSTRACT

Background: Illness perception (IP) is a psychosocial factor involved in several chronic diseases and is associated with relevant clinical outcomes. However, the relationship between IP and health-related quality of life (HRQoL), psychosocial status, and physical activity in daily life (PADL) in subjects with asthma is poorly understood. Objective: To identify groups of subjects with asthma based on their IPs and to assess their association with clinical control, HRQoL, psychosocial disturbances, and PADL. Methods: This cross-sectional study included 149 subjects with moderate to severe asthma. IP, anthropometric data, Asthma Control Questionnaire-7, Asthma Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, PADL (accelerometry), and general self-efficacy (GSE) were assessed. Cluster analysis was performed to identify clusters with similar profiles and investigate their characteristics and differences. Pearson’s correlation coefficient was used to test the associations between IP and other variables. Results: Statistical analyses identified two clusters of subjects with asthma based on IP. Cluster 1 presented worse IP in seven out of eight domains than Cluster 2. Cluster 1 had more negative consequences of the disease, worse understanding, and a high emotional representation of the disease than Cluster 2. Cluster 1 also had a greater extent of asthma symptoms, poor clinical control, worse HRQoL, and more symptoms of anxiety and depression. No difference between clusters was found for PADL or self-efficacy. Conclusion: Subjects with asthma who have worse IP have more negative symptoms, worse clinical control, HRQoL, and symptoms of anxiety and depression.

PMID:35060439 | DOI:10.1080/02770903.2022.2032136

J Clin Exp Neuropsychol. 2022 Jan 21:1-11. doi: 10.1080/13803395.2021.2025344. Online ahead of print.

ABSTRACT

INTRODUCTION: This study’s purpose is to describe the performance of healthy community dwelling Saudi Arabians on fluency tasks and explore the effects of age, sex and education.

METHODS: Arabic-speaking Saudi Arabians > 18 were chosen through convenience sampling. Included were healthy community members whose first language is Arabic. Excluded were anyone with a past history of psychiatric or central neurological diseases, or who was taking medications that affect the central nervous system. Information regarding the variables sex, age, and education was collected. Participants were required to name as many words as they could that started with the letters Ain (ع), Sheen (ش), and Qaf (ق) (letter task), and words that belonged to the categories “countries,” “boy names,” “girl names,” and “four-legged animals” (categorical task). Mean scores were derived for the three letters (ASQ) and four categories (TC). Descriptive statistics, percentile curves, and quantile regressions (0.05, 0.25, 0.5, 0.75, and 0.95) were conducted to determine performance range.

RESULTS: The study included 301 participants, comprising 162 (53.47%) females. The M(SD) for age was 46.74 (16) and for years of education 14 (4.78). The M(SD) for ASQ was 26.26 (10.01), and for TC, 81.56 (20.77). Percentile curves demonstrated an initial increase, followed by a decrease, in performance with increasing age on letter and categorical fluency tasks. Performance scores showed an increase of 1 to 1.5 and 2 to 3.5 words in the letter and categorical tasks, respectively, for each additional year of education across the quantiles (both with p < 0.0001). Males scored higher in the 0.05 and 0.95 quantiles of the letter fluency task only.

CONCLUSION: We demonstrated a range of normative performance from a Saudi Arabian community, with varying age and education levels. The assessment demonstrated the importance of education as a major variable linearly associated with performance, influencing both tasks.

PMID:35060441 | DOI:10.1080/13803395.2021.2025344

J Med Econ. 2022 Jan 21:1-41. doi: 10.1080/13696998.2022.2030599. Online ahead of print.

ABSTRACT

Aims To assess the accuracy of standard parametric survival models, spline models, and mixture cure models (MCMs) fitted to overall survival (OS) data available at the time of submission in the NICE HTA process compared with data subsequently made available.Methods Standard parametric distributions, spline models, and MCMs were fitted to OS data presented in single technology appraisals (TAs) for immune-checkpoint inhibitors (ICIs) in cancer. For each TA, the estimated survival from the fitted models was compared with Kaplan-Meier (KM) data that were made available following the HTA submission using differences between point estimates and restricted area under the curve (AUC) at both the midpoint and the end of additional follow-up. Differences in interval AUC values (calculated for each 6-month period) were also assessed.Results Standard parametric survival models and spline models were more likely to underestimate longer-term survival, irrespective of the measure used to assess model accuracy. MCMs were more likely to over-estimate survival; however, this was improved in some cases by applying an additional hazard of mortality for ‘statistically cured’ patients.Limitations The accuracy of the models was assessed based on much shorter OS data than the period for which extrapolation is needed, which may impact conclusions regarding the most accurate models. The most recent TAs for ICIs have not been captured.Conclusions There are no definitive findings that unquestionably support the use of one specific extrapolation technique. Rather, each has the potential to provide accurate or inaccurate extrapolation to longer-term data in certain circumstances, but the added flexibility of more complex models can be justified for treatments, like ICIs, that have extended survival for patients across disease areas. The use of mortality adjustments for ‘statistically cured’ patients allows decision makers to explore more conservative scenarios in the face of high decision uncertainty.

PMID:35060433 | DOI:10.1080/13696998.2022.2030599