Hepatitis B surface antigen positivity during pregnancy and risk of gestational diabetes mellitus: A systematic review and meta-analysis.

Chronic hepatitis B virus (HBV) infection is a prevalent public health issue worldwide. Its impact on important pregnancy outcomes, such as gestational diabetes mellitus (GDM), has not been clearly established. The findings from published studies are inconsistent. In this systematic review and meta-analysis, we aimed to clarify whether HBV infection manifested during pregnancy is associated with an increased risk of GDM. We searched MEDLINE and EMBASE for cohort studies and case-control studies that investigated the association between maternal hepatitis B surface antigen (HBsAg) positivity and GDM. We pooled adjusted odds ratio (aOR) and unadjusted OR, respectively, using the random-effect generic inverse variance method. We assessed risk of bias using the Quality in Prognosis Studies tool and conducted five pre-specified subgroup analyses. In total, 23 cohort studies involving 3 529 223 participants were included. The risk of GDM was 6.48% (1868/28 829) among HBsAg-positive pregnant women and 3.41% (119 283/3 500 394) among HBsAg-negative pregnant women. Meta-analyses of both unadjusted and adjusted effect estimates showed that HBsAg positivity during pregnancy was associated with higher risk of developing GDM (unadjusted OR 1.35, 95% CI: 1.17 to 1.56, I2  = 82.6%; adjusted OR 1.47, 1.22 to 1.76, I2  = 62%). Among pre-specified subgroup analysis, significant differences were found among studies with high vs low or moderate risk of bias. The results were robust to sensitivity analyses. In conclusion, HBsAg positivity during pregnancy has a moderate effect on an increased risk of GDM. Given the size of the population with HBV infection worldwide, however, this effect could have substantial impact on pregnancy. Further studies are warranted to investigate whether active infection with HBeAg positivity would further elevate the risk of adverse events during pregnancy.

An Evaluation of the Effects of Human Factors and Ergonomics on Health Care and Patient Safety Practices: A Systematic Review.

BACKGROUND: From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. OBJECTIVE: To evaluate the effectiveness of HFE interventions in improving health care workers' outcomes and patient safety and to assess the quality of the available evidence. METHODS: We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. RESULTS: For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers' quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers' attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. CONCLUSION: The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need for scientific and standardized guidelines regarding how HFE should be implemented in health care.

Continuous regional arterial infusion for the treatment of severe acute pancreatitis: a meta-analysis.

BACKGROUND: Continuous regional arterial infusion (CRAI) is a drug delivery system, which dramatically increases the drug concentration in the pancreas. Previous clinical and basic studies have demonstrated the possible therapeutic efficacy of CRAI for severe acute pancreatitis (SAP). This meta-analysis of all published randomized controlled trials (RCTs) was conducted to assess the efficacy and safety of CRAI for the treatment of SAP. DATA SOURCES: Up to August 10, 2014, RCTs comparing CRAI with intravenous infusion for SAP in PubMed, Embase, EBSCO, MEDLINE, Science Citation Index Expanded, Cochrane Library, China Academic Journals Full-Text Database, Chinese Biomedical Literature Database, and Chinese Scientific Journals Database were selected by two independent reviewers. The relative risk (RR) and their 95% confidence intervals (CI) for duration of elevated serum amylase and urine amylase, duration of abdominal pain, infection rate, incidence of complication, overall mortality, curative rate, hospital stay and details of subgroup analysis were extracted. Meta-analyses were made using the software Review Manager (RevMan version 5.10). RESULTS: Six RCTs with 390 patients meeting the inclusion criteria were included in the final analysis. Compared with intravenous infusion route, CRAI significantly shortened the duration of elevated urine amylase (MD=-2.40, 95% CI=-3.20, -1.60; P<0.00001) and the duration of abdominal pain (MD=-1.46, 95% CI=-1.94, -0.98; P<0.00001), decreased the incidence of complication (RR=0.35, 95% CI=0.15, 0.81; P=0.01) and overall mortality (RR=0.25, 95% CI=0.08, 0.78; P=0.02), shortened the duration of hospital stay (MD=-10.36, 95% CI=-17.05, -3.68; P=0.002), and increased the curative rate (RR=1.66, 95% CI=1.13, 2.46; P=0.01). No mortality and catheter-related infections due to CRAI administration was reported in these studies. Subgroup analysis showed that the combination of drug administration via CRAI did not significantly improve the outcomes. CONCLUSION: CRAI is effective for the treatment of SAP, and the combination of drug administration via CRAI did not have a significant effect on the improvement of the outcomes.

[The origin and development of the application of ergonomics in patient safety].

Human factor and ergonomics (HFE) is a discipline focusing on the studies of the relation between the safety and human behavior and system design. The application of HFE in healthcare and patient safety can be traced back to the 1950s. To date, the method and theory of HFE, including its principles and methodology, has played an important part in patient safety activities, and has gained more and more attention by the relevant health and hygienic institutions in developed countries, while its application in developing countries like China is still at the very initial stage with only a few research articles published, most of them theoretical rather than practical.

[The initiative of patient safety culture and its development].

Safety culture is the culture of all the connotations to a safe direction for the purpose of advancing a unified organizational behavior. Safety culture was first introduced to the field of medicine by the American researchers in the 1990s. Subsequently, researchers from different countries initiated the relevant studies and put forward five subcultures of patient safety culture. At present, the patient safety culture research is mainly conducted in the United States, China and the UK of which cross-sectional studies are the most popular study designs including the evaluation of patient safety scale, reliability and validity analysis. Non-sectional studies are focused on the study of subcultures including leadership, communication, cooperation and reports. Compared with the studies abroad, the studies on patient safety culture in China are rather late, yet also mainly on reliability and validity analysis of scales. Most participants we investigated are nurses from teaching hospitals. But in the real healthcare situation, fostering a positive safety culture is still very lacking and many ideas and behaviors are in the state of traditional blaming culture.

Prognostic value of fluorine-18-fluorodeoxyglucose positron emission tomography or PET-computed tomography in cervical cancer: a meta-analysis.

OBJECTIVE: We pooled the data from published studies to estimate the prognostic value of fluorine-18-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) or PET/computed tomography (CT) in cervical cancer patients. METHODS: We searched MEDLINE, EMBASE, and PUBMED to identify studies investigating the association of 18F-FDG PET or PET/CT with clinical survival outcomes of patients with cervical cancer. The summarized hazard ratio (HR) was estimated by using fixed- or random-effect model according to heterogeneity between trails. RESULTS: We analyzed a total number of 1854 patients from 16 studies and found that positive pretreatment FDG-PET images were significantly associated with poorer event-free survival (hazard ratio [HR], 2.681; 95% confidence interval [CI], 2.059-3.490) and overall survival (HR, 2.063; 95% CI, 1.023-4.158). Furthermore, metabolic response of therapy as shown on posttreatment PET images was also capable of predicting event-free survival and overall survival with statistical significance, and the HR was 2.030 (95% CI, 1.537-2.681) and 2.322 (95% CI, 1.485-3.630), respectively. CONCLUSIONS: Uptake of 18F-FDG on PET or PET/CT either before or after treatment has a promising value of both predicting survival outcomes for patients with cervical cancer and identifying patients for more aggressive treatment.

Hospital survey on patient safety culture in China.

BACKGROUND: Patient safety culture is an important measure in assessing the quality of health care. There is a growing recognition of the need to establish a culture of hospital focused on patient safety. This study explores the attitudes and perceptions of patient safety culture for health care workers in China by using a Hospital Survey on Patient Safety Culture (HSPSC) questionnaire and comparing it with the psychometric properties of an adapted translation of the HSPSC in Chinese hospitals with that of the US. METHOD: We used the modified HSPSC questionnaire to measure 10 dimensions of patient safety culture from 32 hospitals in 15 cities all across China. The questionnaire included 1160 Chinese health-care workers who consisted of predominately internal physicians and nurses. We used SPSS 17.0 and Microsoft Excel 2007 to conduct the statistical analysis on survey data including descriptive statistics and validity and reliability of survey. All data was input and checked by two investigators independently. RESULT: A total of 1500 questionnaires were distributed of which 1160 were responded validly (response rate 77%). The positive response rate for each item ranged from 36% to 89%. The positive response rate on 5 dimensions (Teamwork Within Units, Organization Learning-Continuous Improvement, Communication Openness, Non-punitive Response and Teamwork Across Units) was higher than that of AHRQ data (P < 0.05). There was a statistical difference on the perception of patient safety culture in groups of different work units, positions and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α = 0.84). CONCLUSION: The results show that amongst the health care workers surveyed in China there was a positive attitude towards the patient safety culture within their organizations. The differences between China and the US in patient safety culture suggests that cultural uniqueness should be taken into consideration whenever safety culture measurement tools are applied in different culture settings.

Patients for patient safety in China: a cross sectional study.

OBJECTIVES: To investigate the baseline status of patients' awareness, knowledge, and attitudes to patient safety in China, and to determine the factors that influence patients' involvement in patient safety. METHODS: We conducted a cross sectional survey using questionnaires adapted from recent studies on patient safety from outside China. The items included medical errors, infection, medication safety, and other aspects of patient safety. The questionnaire included 17 items and 5 domains. The survey was conducted between Jan. 2009 and Dec. 2010 involving 1000 patients from ten grade-A hospitals in seven provinces or cities in China. Most patients from the surgery departments completed the questionnaires voluntarily and anonymously. Five reviewers independently input the data into Microsoft Excel 2003, and the data were double-checked. Data were analyzed using SPSS 15.0 software for differences in the perceptions and attitudes of patients toward patient safety among different genders, ages, and regions. RESULTS: We distributed 1000 questionnaires and collected 959 completed questionnaires (response rate: 96%). Among the respondents, 58% of patients did not know what medical error is. Sixty-five percent of patients wanted disclosure of all medical errors. After errors occurred, 58% of patients wanted explanations of all possible harms that had resulted. Among 187 patients who had experienced medical errors, 83% of patients had sought appropriate legal action. About 52% of patients understood hospital infection, but 28% patients did not know that infections could occur in hospital. Seventy-eight percent of patients thought that medical staff should wash their hands before examining patients. More than half of the patients (68%) were willing to remind the staff of hygiene if they saw unsanitary conditions in a health clinic. Only 14% of patients knew the side effects of medications that they took. CONCLUSION: The majority of patients surveyed expressed willingness to contribute to patient safety, but their knowledge about patient safety practices was generally very limited.

Effect of injection of brucea javanica oil emulsion plus chemoradiotherapy for lung cancer: a review of clinical evidence.

OBJECTIVE: Injection of brucea javanica oil emulsion (IBJOE), one of Chinese patent drugs has been widely used for lung cancer (LC) in China, and is known to provide some favorable outcomes, in particular when it combined with conventional treatment. However, little available best evidence is known about its effect and safety. This paper aims to evaluate the effectiveness and safety of IBJOE plus chemoradiotherapy to alleviate symptoms of LC patients. METHODS: A complete literature searching was conducted in databases including Chinese Biomedical Literature Database, China Academic Journals Full-text Database, Chinese Scientific Journals Database, the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE to identify randomized controlled trials (RCTs) of IBJOE with chemoradiotherapy versus chemoradiotherapy alone for LC patients regardless of blinding, duration of treatment or duration of follow-up. All searching dates were from the beginning to December 2011. Quality of the included studies was assessed using the method by Cochrane Reviewer Handbook, and data analysis was performed using RevMan 5.10 software developed by The Cochrane Collaboration. RESULTS: The searching yielded over 1371 relevant citations, most of which did not meet the inclusion criteria. Finally, only 21 RCTs involving 1619 patients were included, and all the studies were of poor quality. Pooled analyses were performed to reveal that compared with chemoradiotherapy alone, IBJOE plus chemoradiotherapy had a better complete response rate (relative risk (RR) = 1.42; 95% CI 1.05 to 1.92; P = 0.02) and improved quality of life (RR = 1.83; 95% CI 1.63 to 2.07; P < 0.00001) measured by Karnofsky Performance Status scale. In addition, there was a significant difference on the outcome of long-term survival rate, level of immune function, and some incidences of adverse effects. CONCLUSIONS: IBJOE plus chemoradiotherapy may have positive effects on LC patients in response rate, improvement of quality of life, and reducing incidences of some adverse effects compared with chemoradiotherapy alone. However, the results need to be viewed with caution because of low quality of the included studies.

Knowledge, skills, and attitudes of medical students to patient safety: a cross-sectional pilot investigation in China.

BACKGROUND: To reduce harm caused by health care is a global priority. Medical students should be able to recognize unsafe conditions, systematically report errors, and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients. Therefore, incorporating knowledge about patient safety into medical school curriculums is an urgent necessity. OBJECTIVES: To describe the extent to which Chinese medical students have patient safety in their knowledge, skills, and attitudes so as to provide evidence for implementation of a patient safety curriculum in medical schools, and to assess the quality of this investigative questionnaire. METHODS: Our questionnaire of 31 items was developed based on a 2008 WHO pilot study for a patient safety curriculum guide. Our investigation was conducted in three university medical schools in China. Year 3 and year 4 medical students were asked to complete an anonymous questionnaire in their classroom settings. All items were scored from 1 to 5. Differences in responses among different universities, genders, and levels, as well as the validity and reliability of the questionnaire, were analyzed using SPSS 15.0. RESULTS: A total of 500 questionnaires were distributed, and 143 male and 262 female students completed the survey. An average of 0.96% of survey questions were not answered, of which the most frequently unanswered item was "what will happen when medical error occurs?" The students' attitudes to learning about patient safety were positive, although their knowledge of medical error and how to report error was poor. There were no statistical differences among different medical schools and levels in any item responses. The only gender difference appeared in the response to "I would like to discuss with others when I made a medical error." There was a good coherence of reliability in sections 2, 3, and 4 of the questionnaire (Cronbach's alpha > 0.8), while sections 5 and 6 scored as less reliable. The validity of the questionnaire was good. CONCLUSIONS: Although medical students' understanding of patient safety is very poor in China, the students have a positive attitudes to learning about the knowledge of patient safety in their future careers.