Tag: statistics

Zhonghua Er Ke Za Zhi. 2023 Sep 2;61(9):827-832. doi: 10.3760/cma.j.cn112140-20230328-00216.

ABSTRACT

Objective: To investigate the association between Helicobacter pylori (Hp) virulence factor genotypes and the degree and activity of gastric mucosa pathological changes in pediatric gastroduodenal diseases. Methods: This retrospective cohort study was conducted from May 2020 to October 2020. The frozen strains of Hp, which were cultured with the gastric mucosa of 68 children with gastroscopy confirmed gastroduodenal diseases who visited the children’s hospital of Zhejiang University School of Medicine from April 2012 to December 2014, were resuscitated. After extracting DNA from these Hp strains, PCR amplification and agarose gel electrophoresis were performed to determine the detection rate of cytotoxin-associated protein A (cagA),vacuolating cytotoxin A (vacA)(s1a、s1b/s2,m1/m2), outer inflammatory protein A (oipA),blood group antigen binding adhesin (babA),duodenal ulcer promoting protein A (dupA) genes; oipA genes were sequenced to determine the gene status. The patients were divided into different groups according to the findings of gastroscopy and gastric mucosa pathology. The detection rates of various virulence factor genotypes among different groups were compared using χ² tests or Fisher’s exact tests. Results: The 68 Hp strains all completed genetic testing. According to the diagnostic findings of gastroscopy, the 68 cases were divided into 47 cases of superficial gastritis and 21 cases of peptic ulcer. Regarding the pathological changes of gastric mucosa, 8 cases were mild, and 60 cases were moderate and severe according to the degree of inflammation; 61 cases were active and 7 cases inactive according to the activity of inflammation. The overall detection rates of cagA, vacA, vacA s1/m2, functional oipA, babA2, and dupA virulence factor genes were 100% (68/68), 100% (68/68), 94% (64/68), 99% (67/68), 82% (56/68), and 71% (48/68), respectively. In the superficial gastritis group, their detection rates were 100% (47/47), 100% (47/47), 96% (45/47), 98% (46/47), 81% (38/47), and 70% (33/47), respectively; in the peptic ulcer group, their detection rates were 100% (21/21), 100% (21/21), 90% (19/21), 100% (21/21), 86% (18/21), and 71% (15/21), respectively. There was no statistically significant difference between the two groups (all P>0.05). In the mild gastric mucosa inflammation group, the detection rates of the above six genotypes were 8/8, 8/8, 8/8, 7/8, 7/8, and 5/8, respectively; and in the moderate to severe inflammation groups, the detection rates were 100% (60/60), 100% (60/60), 93% (56/60), 100% (60/60), 82% (49/60), and 72% (43/60), respectively, with no statistically significant difference between the two groups (all P>0.05). In the active inflammation group, the detection rate of six genotypes were 100% (61/61), 100% (61/61), 93% (57/61), 98% (60/61), 82% (50/61), and 72% (44/61), respectively; and in the inactive inflammation group, they were 7/7, 7/7, 7/7, 7/7, 6/7, and 4/7, respectively. Again, there was no statistically significant difference between the two groups (all P>0.05). There was no statistically significant difference in the detection rate of combinations of 4 or 5 virulence factor genes among the different groups (all P>0.05). Conclusions: CagA, vacA, vacA s1/m2, functional oipA, babA2, and dupA genes are not associated with superficial gastritis and peptic ulcer in children, or with the degree and activity of gastric mucosa pathological inflammation. Different gene combinations of cagA, vacA, oipA, babA2, and dupA have no significant effects on predicting the clinical outcome of Hp infection in children.

PMID:37650165 | DOI:10.3760/cma.j.cn112140-20230328-00216

Zhonghua Er Ke Za Zhi. 2023 Sep 2;61(9):805-810. doi: 10.3760/cma.j.cn112140-20230509-00323.

ABSTRACT

Objective: To investigate the clinical characteristics and related factors of corticosteroid induced adrenal crisis (AC) in children with primary nephrotic syndrome (NS). Methods: Case control study. The case group included 7 children aged 1 to 18 years with NS combined with AC hospitalized in Peking University First Hospital from January 2016 to May 2021 (AC group). According to the ratio of case group: control group 1: 4, 28 children aged 1 to 18 years who were diagnosed with NS without AC during the same period were matched as controls (non-AC group). Clinical data were collected. The clinical characteristics of AC were described. The clinical parameters were compared between the 2 groups by t test, Mann-Whitney U test or Fisher’s test. Receiver operating characteristic (ROC) curve was used to analyze the cutoff values of clinical parameters for prediction of AC. Results: The AC group included 4 boys and 3 girls aged 6.9 (4.6, 10.8) years. The non-AC group included 20 boys and 8 girls aged 5.2 (3.3, 8.4) years. All AC events occurred during the relapse of NS with infection. Seven children had gastrointestinal symptoms such as nausea, vomiting and abdominal pain. Six children had poor mental state or impaired consciousness. No significant differences in NS course, corticosteroid treatment course, corticosteroid type, steroid dosage, steroid medication interval, the proportion of gastroenteritis and fever existed between the two groups (all P>0.05). Compared with the non-AC group, the duration from the onset of the relapse of NS until hospitalization in the AC group was significantly shorter (0.2 (0.1, 0.6) vs. 1.0 (0.4, 5.0) month,U=25.50, P=0.005). The 24 h urinary total protein (UTP) level was significantly higher in the AC group (193 (135, 429) vs. 81 (17, 200) mg/kg, U=27.00,P=0.036) than the non-AC group. The serum albumin level in the AC group was significantly lower((13.1±2.1) vs. (24.5±8.7) g/L,t=-6.22,P<0.001) than the non-AC group. There were significantly higher total white blood cell counts ((26±9)×10⁹ vs. (11±5)×10⁹/L,t=4.26,P=0.004), percentage of neutrophils (0.71±0.08 vs. 0.60±0.19,t=2.56,P=0.017) and the proportion of children with C reactive protein level≥8 mg/L (3/7 vs. 0,P=0.005) in the AC group than in the non-AC group. ROC curve analysis showed that the cutoff value of 24 h UTP was 122 mg/(kg·d) with a sensitivity of 100.0% and specificity of 70.4%. The cutoff value of serum albumin was 17.0 g/L with a sensitivity of 100.0% and specificity of 82.1%. Conclusions: Gastrointestinal symptoms and poor mental state were prominent manifestations of AC in children with NS. High 24 h UTP level, low serum albumin level, high peripheral white blood cell counts, high neutrophils percentage, and high C-reactive protein level during the early stage of NS relapse may be related to the occurrence of AC in children with NS.

PMID:37650162 | DOI:10.3760/cma.j.cn112140-20230509-00323

BMJ Evid Based Med. 2023 Aug 30:bmjebm-2023-112350. doi: 10.1136/bmjebm-2023-112350. Online ahead of print.

ABSTRACT

OBJECTIVES: In clinical decision-making, physicians take actions such as prescribing treatment only when the probability of disease is sufficiently high. The lowest probability at which the action will be considered, is the action threshold. Such thresholds play an important role whenever decisions have to be taken under uncertainty. However, while several methods to estimate action thresholds exist, few methods give satisfactory results or have been adopted in clinical practice. We piloted the adapted nominal group technique (aNGT), a new prescriptive method based on a formal consensus technique adapted for use in clinical decision-making.

DESIGN, SETTING AND PARTICIPANTS: We applied this method in groups of postgraduate students using three scenarios: treat for rifampicin-resistant tuberculosis (RR-TB), switch to second-line HIV treatment and isolate for SARS-CoV-2 infection.

INTERVENTIONS: The participants first summarise all harms of wrongly taking action when none is required and wrongly not taking action when it would have been useful. Then they rate the statements on these harms, discuss their importance in the decision-making process, and finally weigh the statements against each other.

MAIN OUTCOME MEASURES: The resulting consensus threshold is estimated as the relative weights of the harms of the false positives divided by the total harm, and averaged out over participants. In some applications, the thresholds are compared with an existing method based on clinical vignettes.

RESULTS: The resulting action thresholds were just over 50% for RR-TB treatment, between 20% and 50% for switching HIV treatment and 43% for COVID-19 isolation. These results were considered acceptable to all participants. Between sessions variation was low for RR-TB and moderate for HIV. Threshold estimates were moderately lower with the method based on clinical vignettes.

CONCLUSIONS: The aNGT gives sensible results in our pilot and has the potential to estimate action thresholds, in an efficient manner, while involving all relevant stakeholders. Further research is needed to study the value of the method in clinical decision-making and its ability to generate acceptable thresholds that stakeholders can agree on.

PMID:37648419 | DOI:10.1136/bmjebm-2023-112350

Int J Gynecol Cancer. 2023 Aug 30:ijgc-2023-004533. doi: 10.1136/ijgc-2023-004533. Online ahead of print.

ABSTRACT

OBJECTIVE: The main objective of the study was to assess the influence of different clinical and therapeutic variables on the oncological outcomes of patients with endometrial cancer relapse. In particular, we evaluated the impact of cytoreductive surgery with the achievement of complete gross resection.

METHODS: This is a multicenter retrospective cohort study conducted in three centers in Italy and including all patients with first relapse of endometrial cancer from January 2010 to December 2021.

RESULTS: Data from 331 women with recurrent endometrial cancer were analyzed. Secondary cytoreductive surgery was performed in 56.2% of cases (186 patients). Complete gross resection was achieved in 178 patients (95.7%). Complete gross resection conferred a statistically significant survival benefit both for post-relapse survival and post-relapse free survival (3 years post-relapse survival: 75.4% vs 56.4%, p<0.001; 3 years post-relapse free survival: 32.6% vs 26.5%, p=0.027). At multivariate Cox regression analysis, age ≥75 years, Eastern Cooperative Oncology Group Performance Status ≥2, the advanced-metastatic risk group, complete gross resection, and multiple site relapses were identified as independent significant predictors for post-relapse survival; regarding post-relapse free survival, only age ≥75, the high and advanced-metastatic risk groups, and complete gross resection confirmed their statistical significance.

CONCLUSIONS: Secondary cytoreductive surgery with achievement of complete gross resection was confirmed to be an independent positive predictor for survival in patients with recurrent endometrial cancer and should be considered a valid primary treatment in the therapeutic decision-making process.

PMID:37648408 | DOI:10.1136/ijgc-2023-004533

Risk Anal. 2023 Aug 30. doi: 10.1111/risa.14210. Online ahead of print.

ABSTRACT

As acute gastrointestinal (AGI) disease patients only sometimes seek medical care or submit stool samples for testing, and laboratories cannot detect or identify the pathogen, most cases of foodborne gastroenteritis still need to be identified through public health monitoring. We conducted a population survey and sentinel hospital surveillance to determine the burden of foodborne gastroenteritis caused by non-typhoidal Salmonella enterica (NTS) and Vibrio parahaemolyticus infection, from July 2018 to June 2019 in Zhejiang province, China, and a model for calculating disease burden established. Using the burden of illness pyramid model, we estimated that there were 140.3 cases of NTS infection and 136.2 cases of V. parahaemolyticus infection. We estimated annual incidence per 100,000 population in Zhejiang province as 236 (95% confidence interval [CI] 208-267) and 206 (95% CI 155-232) cases for foodborne NTS and V. parahaemolyticus gastroenteritis, respectively. The results show that AGI caused by these two pathogens constitutes a substantial burden in the Zhejiang population. The health burden of AGI estimations caused by NTS and V. parahaemolyticus in this study can serve as a strategic framework to direct policy and intervention.

PMID:37648395 | DOI:10.1111/risa.14210

BMJ Open. 2023 Aug 30;13(8):e072700. doi: 10.1136/bmjopen-2023-072700.

ABSTRACT

INTRODUCTION: Regular physical activity during pregnancy is effective in preventing diseases and promoting the health outcomes of mothers and babies. However, the level of physical activity among them is not ideal. Especially in China, the proportion of pregnant women who meet the recommendation of physical activity in the guidelines is even lower. Thus, we aim to evaluate the prevalence of meeting physical activity recommendation and its influencing factors during pregnancy in China.

METHODS AND ANALYSIS: This protocol is developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. PubMed, Web of Science, Scopus, CINAHL, MEDLINE, PsycINFO, EMBASE, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (Weipu) and WanFang Data will be comprehensively searched by two reviewers. Studies that report the prevalence of Chinese pregnant women meeting physical activity recommendation will be included. Two reviewers will independently assess eligibility, extract data and evaluate methodological quality. Data including authors, publication years, language, geographical region, tools, trimesters, prevalence and influence factors will be extracted. Data will be analysed by Stata V.11 statistical software.

ETHICS AND DISSEMINATION: No formal ethics approval is required for this protocol and no primary data are to be collected. Findings from this review may be useful to develop interventions for the physical activity of pregnant women in China. The results will be disseminated through peer-reviewed journals, conference presentations and public events.

PROSPERO REGISTRATION NUMBER: CRD42022372722.

PMID:37648391 | DOI:10.1136/bmjopen-2023-072700

BMJ Open. 2023 Aug 30;13(8):e071705. doi: 10.1136/bmjopen-2023-071705.

ABSTRACT

INTRODUCTION: Total elbow replacement (TER) has higher failure rates requiring revision surgery compared with the replacement of other joints. Understanding the factors associated with failure is essential for informed decision-making between patients and clinicians, and for reducing the failure rate. This review aims to identify, describe and appraise the literature examining prognostic factors for failure of TER.

METHODS AND ANALYSIS: This systematic review will be conducted and reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Electronic literature searches will be conducted using Medline, EMBASE, PubMed and Cochrane. The search strategy will be broad, including a combination of subject headings (MESH) and free text search. This search will be supplemented with a screening of reference lists of the included studies and relevant reviews. Two independent reviewers will screen all search results in two stages (title and abstract, and full text) based on the Population, Index prognostic factor, Comparator prognostic factor, Outcome, Time and Setting criteria. The types of evidence included will be randomised trials, non-randomised trials, prospective and retrospective cohort studies, registry studies and case-control studies. If the literature lacks enough studies, then case series with 50 or more TERs will be considered for inclusion. Data extraction and risk of bias assessment for included studies will be performed by two independent reviewers using the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies for Prognostic Factors and Quality In Prognostic Studies tools.Meta-analyses of prognostic estimates for each factor will be undertaken for studies that are deemed to be sufficiently robust and comparable. Several challenges are likely to arise due to heterogeneity between studies, therefore, subgroup and sensitivity analyses will be performed to account for the differences between studies. Heterogeneity will be assessed using Q and I² statistics. If I²>40% then pooled estimates will not be reported. When quantitative synthesis is not possible, a narrative synthesis will be undertaken. The quality of the evidence for each prognostic factor will be assessed using the Grades of Recommendation Assessment, Development and Evaluation tool.

PROSPERO REGISTRATION NUMBER: CRD42023384756.

PMID:37648384 | DOI:10.1136/bmjopen-2023-071705

BMJ Open. 2023 Aug 30;13(8):e063586. doi: 10.1136/bmjopen-2022-063586.

ABSTRACT

OBJECTIVES: The aim of the global DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings (DISCOVER) Study was to provide a comprehensive real world assessment of the treatment pattern changes for patients with type 2 diabetes. The aim of this analysis was to assess the metabolic control and the annual incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy.

DESIGN: This study is part of the observational, longitudinal, prospective multinational DISCOVER Study.

SETTING: Governmental and private health sectors from different regions within Saudi Arabia.

PARTICIPANTS: The study recruited 519 patients with type 2 diabetes aged ≥18 years who were switching to second-line therapy. Patients who were already using insulin/injectable agents, patients with type 1 diabetes, pregnant women, and patients undergoing dialysis or with a history of renal transplantation were excluded.

PRIMARY AND SECONDARY OUTCOME MEASURES: Metabolic control among patients with type 2 diabetes mellitus; fear of hypoglycaemia; quality of life; and the incidence of complications, hypoglycaemic events and/or hospitalisations. Data were analysed using descriptive statistics.

RESULTS: A total of 519 patients were recruited with a mean age of 52.4±11 years. Of these participants, 54.7% were male and 45.3% were female. The incidence of hypoglycaemia was 56.72/1000 patient-years. The Hypoglycemia Fear Survey II showed a significant increase in patient worry related to hypoglycaemia from 6.4±11.9 at baseline to (p=0.0446) at the 36-month follow-up. The incidence of hospitalisation was 30.81/1000 patient-years. There was a moderate improvement in glycaemic control, represented as an HbA1c reduction from 8.8% at baseline to 8.2% at the 36-month follow-up. The incidence of macroangiopathy was 24.51/1000 patient-years and the incidence of microvascular complications such as retinopathy and albuminuria was 47.00/1000 patient-years and 221.71/1000 patient-years, respectively. The mean score of fear of hypoglycaemia showed an increase with 13.0±21.5 at baseline to 16.1±22.2 at the 36-month follow-up. When assessing the patients’ quality of life, there was an improvement in the mental component score from 47.4±9.1 at baseline to 53.0±6.7 at the 36-month follow-up.

CONCLUSIONS: Treatment intensification decisions should be made individually, weighing the benefit of good glycaemic control against the risk of hypoglycaemia.

TRIAL REGISTRATION NUMBER: NCT02322762 and NCT02226822.

PMID:37648382 | DOI:10.1136/bmjopen-2022-063586

BMJ Open. 2023 Aug 30;13(8):e072546. doi: 10.1136/bmjopen-2023-072546.

ABSTRACT

OBJECTIVES: Individuals under-recruited in diabetes research studies include those not seen at endocrinology centres and those from rural, low socioeconomic and/or under-represented racial/ethnic groups. The purpose of this descriptive analysis is to detail recruitment and retention efforts of Project ECHO Diabetes clinical sites affiliated with Stanford University and University of Florida.

DESIGN: Prospective collection of participant engagement and qualitative analysis of barriers and facilitators of research engagement within Project ECHO Diabetes, a virtual tele-education programme for healthcare providers in the management of individuals with insulin-requiring diabetes.

SETTING: Data were collected at the patient level, provider level and clinic level between 1 May 2021 and 31 July 2022.

PARTICIPANTS: Participants and study personnel were recruited from 33 Project ECHO Diabetes sites in California and Florida.

OUTCOMES: We report study completion rates for participants recruited into 33 Project ECHO Diabetes sites. Using barrier analysis, a methodology designed for the real-time assessment of interventions and system processes to identify barriers and facilitators, study personnel identified significant barriers to recruitment and retention and mapped them to actionable solutions.

RESULTS: In total, 872 participants (California n=495, Florida n=377) were recruited with differing recruitment rates by site (California=52.7%, Florida=21.5%). Barrier analysis identified lack of trust, unreliable contact information, communication issues and institutional review board (IRB) requirements as key recruitment barriers. Culturally congruent staff, community health centre (CHC) support, adequate funding and consent process flexibility were solutions to address recruitment challenges. Barriers to retention were inconsistent postal access, haemoglobin A1c kit collection challenges, COVID-19 pandemic and broadband/connectivity issues. Additional funding supporting research staff and analogue communication methods were identified as solutions address barriers to retention.

CONCLUSIONS: Funded partnerships with CHCs, trusted by their local communities, were key in our recruitment and retention strategies. IRB consent process flexibility reduced barriers to recruitment. Recruiting historically under-represented populations is feasible with funding aimed to address structural barriers to research participation.

PMID:37648378 | DOI:10.1136/bmjopen-2023-072546

JACC Cardiovasc Interv. 2023 Aug 28;16(16):1990-2000. doi: 10.1016/j.jcin.2023.05.030.

ABSTRACT

BACKGROUND: Computed tomography angiography (CTA) and invasive coronary angiography (ICA) are routinely performed before transcatheter aortic valve replacement (TAVR) to assess aortic root anatomy and screen for coronary artery disease (CAD), respectively.

OBJECTIVES: This study explored the efficacy of CTA as a screening tool for significant proximal CAD before TAVR.

METHODS: With proper ethical oversight, patients undergoing TAVR at Cleveland Clinic with a preprocedural CTA and invasive coronary angiography (ICA), and no prior percutaneous intervention, were identified from 2015 to 2021. Blinded to ICA results, the authors reviewed the left main, proximal left anterior descending coronary artery, proximal left circumflex coronary artery, and proximal right coronary artery by CTA coronary reconstruction to assess for nonsignificant stenosis (0% to 49%), moderate stenosis (50% to 69%), and severe stenosis (≥70%). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen Kappa statistic were analyzed.

RESULTS: 2,217 patients (53.4% male, age 79.2 ± 8.5 years) met inclusion criteria. CTA evaluation revealed a sensitivity of 90%, specificity of 92%, PPV of 74%, and NPV of 97% for detecting ≥50% stenosis. Using a ≥70% stenosis cutoff, evaluation revealed a sensitivity of 91%, specificity of 97%, PPV of 83%, and NPV of 99%. Assessment of bypass graft patency revealed a sensitivity of 86%, specificity of 97%, PPV of 84%, and NPV of 98%. Cohen Kappa analysis indicated substantial to near perfect agreement between pre-TAVR CTA and ICA.

CONCLUSIONS: Pre-TAVR CTA has a high NPV for high-grade proximal stenosis of each coronary artery. As a result, CTA can be used as a screening tool to rule out significant proximal CAD in patients undergoing TAVR.

PMID:37648347 | DOI:10.1016/j.jcin.2023.05.030