Methodology and experiences of rapid advice guideline development for children with COVID-19: responding to the COVID-19 outbreak quickly and efficiently.

BACKGROUND: Rapid Advice Guidelines (RAG) provide decision makers with guidance to respond to public health emergencies by developing evidence-based recommendations in a short period of time with a scientific and standardized approach. However, the experience from the development process of a RAG has so far not been systematically summarized. Therefore, our working group will take the experience of the development of the RAG for children with COVID-19 as an example to systematically explore the methodology, advantages, and challenges in the development of the RAG. We shall propose suggestions and reflections for future research, in order to provide a more detailed reference for future development of RAGs. RESULT: The development of the RAG by a group of 67 researchers from 11 countries took 50 days from the official commencement of the work (January 28, 2020) to submission (March 17, 2020). A total of 21 meetings were held with a total duration of 48 h (average 2.3 h per meeting) and an average of 16.5 participants attending. Only two of the ten recommendations were fully supported by direct evidence for COVID-19, three recommendations were supported by indirect evidence only, and the proportion of COVID-19 studies among the body of evidence in the remaining five recommendations ranged between 10 and 83%. Six of the ten recommendations used COVID-19 preprints as evidence support, and up to 50% of the studies with direct evidence on COVID-19 were preprints. CONCLUSIONS: In order to respond to public health emergencies, the development of RAG also requires a clear and transparent formulation process, usually using a large amount of indirect and non-peer-reviewed evidence to support the formation of recommendations. Strict following of the WHO RAG handbook does not only enhance the transparency and clarity of the guideline, but also can speed up the guideline development process, thereby saving time and labor costs.

Guidelines for the prevention and management of children and adolescents with COVID-19.

Children are the future of the world, but their health and future are facing great uncertainty because of the coronavirus disease 2019 (COVID-19) pandemic. In order to improve the management of children with COVID-19, an international, multidisciplinary panel of experts developed a rapid advice guideline at the beginning of the outbreak of COVID-19 in 2020. After publishing the first version of the rapid advice guideline, the panel has updated the guideline by including additional stakeholders in the panel and a comprehensive search of the latest evidence. All recommendations were supported by systematic reviews and graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Expert judgment was used to develop good practice statements supplementary to the graded evidence-based recommendations. The updated guideline comprises nine recommendations and one good practice statement. It focuses on the key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin (IVIG) for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health. CONCLUSION: This updated evidence-based guideline intends to provide clinicians, pediatricians, patients and other stakeholders with evidence-based recommendations for the prevention and management of COVID-19 in children and adolescents. Larger studies with longer follow-up to determine the effectiveness and safety of systemic glucocorticoids, IVIG, noninvasive ventilation, and the vaccines for COVID-19 in children and adolescents are encouraged. WHAT IS KNOWN: • Several clinical practice guidelines for children with COVID-19 have been developed, but only few of them have been recently updated. • We developed an evidence-based guideline at the beginning of the COVID-19 outbreak and have now updated it based on the results of a comprehensive search of the latest evidence. WHAT IS NEW: • The updated guideline provides key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health.

Randomized Controlled Trial Comparing Drug-coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Critical Limb Ischemia: The SINGA-PACLI Trial.

Background There is a paucity of randomized trials demonstrating superior efficacy of drug-coated balloon angioplasty (DCBA) compared with conventional percutaneous transluminal angioplasty (PTA) for below-the-knee arterial disease in patients with -critical limb ischemia. Purpose To compare DCBA versus PTA for below-the-knee lesions in participants with critical limb ischemia through 12 months. Materials and Methods In this prospective, randomized, two-center, double-blind superiority study, participants with critical limb ischemia with rest pain or tissue loss with atherosclerotic disease in the native below-the-knee arteries were randomly assigned (in a one-to-one ratio) to DCBA or PTA after stratification for diabetes and renal failure between November 2013 and October 2017. The primary efficacy end point was angiographic primary patency at 6 months analyzed on an intention-to-treat basis. Secondary end points through 12 months were composed of major adverse events including death and major amputations, wound healing, limb salvage, clinically driven target-lesion revascularization, and amputation-free survival. Primary and binary secondary end points, analyzed by using generalized-linear model and time-to-event analyses, were estimated with Kaplan-Meier survival curves and hazard ratios (Cox regression). Results Seventy participants (mean age, 61 years ± 10 [standard deviation]; 43 men) in the DCBA group and 68 (mean age, 64 years ± 10; 50 men) in the PTA group were evaluated. The percentage of patients with angiographic primary patency at 6 months was 43% (30 of 70) in the DCBA group and 38% (26 of 68) in the PTA group (P = .48). Through 12 months, the percentage of deaths was similar: 21% in the DCBA group and 16% in the PTA group (P = .43). Amputation-free survival rate assessed with Kaplan-Meier curves differed through 12 months: 59% (41 of 70) in the DCBA group compared with 78% (53 of 68) in the PTA group (P = .01). Conclusion In participants with critical limb ischemia, the drug-coated balloon angioplasty group and the conventional percutaneous transluminal angioplasty group had similar primary patency rates at 6 months after treatment of below-the-knee arteries. Amputation-free survival rates through 12 months were higher in the percutaneous transluminal angioplasty group. © RSNA, 2021 Online supplemental material is available for this article.

Clinical and socio-demographic correlates of anxious distress in Asian outpatients with major depressive disorder.

BACKGROUND: Anxious distress in major depressive disorder (MDD) is common and associated with poor outcomes and management difficulties. AIMS: This post hoc analysis aimed to examine the socio-demographic and clinical correlates of anxiety distress in Asian outpatients with MDD. METHODS: Instead of two out of five specifiers defined by the Diagnostic and Statistical Manual Version-5, anxious distress defined in this study was operationalized as the presence of at least two out of four proxy items drawn from the 90-item Symptom Checklist, Revised (SCL-90-R). Other measures included the Montgomery-Asberg Depression Rating Scale (MADRS), the Fatigue Severity Scale, the Sheehan Disability Scale and the Multidimensional Scale of Perceived Social Support. RESULTS: The data of 496 patients with MDD were included. Anxious distress was found in 371 participants (74.8%). The binary logistic regression analysis found that anxious distress was independently and significantly correlated with working status, higher MADRS scores, severe insomnia and functional impairment. CONCLUSIONS: Three-fourths of Asian patients with MDD in tertiary care settings may have DSM-5 anxious distress of at least moderate distress. Its prevalence may vary among working groups. The specifier was associated with greater depressive symptom severity, severe insomnia and functional impairment.

Efficacy and safety of MLC601 (NeuroAiD®), a traditional Chinese medicine, in poststroke recovery: a systematic review.

BACKGROUND: Subsequent to a pooled analysis of 2 trials, several more studies have been published assessing the benefit of MLC601 in stroke patients. Hence, it is timely to conduct an updated meta-analysis to frame the interpretation of the results of an ongoing large multicenter, randomized, double-blind, placebo-controlled study. Therefore, we conducted a systematic review of the efficacy of MLC601 in improving the recovery of stroke patients. METHODS: PubMed® and the Cochrane Library® databases were searched for trials evaluating MLC601 in stroke patients. Primary outcome was functional independence, assessed by the Barthel Index or the Diagnostic Therapeutic Effects of Apoplexy scoring system, item 8. Secondary outcomes were improvement in functional independence scores, motor recovery, reduction in visual field defect and increase in cerebral blood flow. Two authors performed the article selection, appraisal and data extraction while resolving differences through discussion or consulting a third author. Data were analyzed in RevMan5®. Meta-analysis was conducted using a random effects model. RESULTS: This review included 6 studies with overall low risk of bias but some clinical heterogeneity. MLC601 increased the chances of achieving functional independence after stroke compared to control treatments (risk ratio, 2.35; 95% CI, 1.31-4.23). No deaths and 4 serious adverse events were reported in the MLC601 group, although detail was sparse with inconsistent reporting. CONCLUSIONS: There is evidence that MLC601 as an add-on to standard treatment could be effective in improving functional independence and motor recovery and is safe for patients with primarily nonacute stable stroke.

Stress myocardial perfusion imaging for the evaluation and triage of chest pain in the emergency department: a randomized controlled trial.

BACKGROUND: Patients with acute coronary syndrome (ACS) often present atypically. In a randomized controlled trial, we studied whether adding stress myocardial perfusion imaging (SMPI) to an evaluation strategy for emergency department (ED) patients presenting with chest pain more effectively identifies patients with ACS. METHODS: Participants were randomized to standard ED chest pain protocol (clinical assessment) or standard protocol supplemented with SMPI results. During 6 hours of electrocardiogram (ECG) monitoring and serial cardiac markers (creatine kinase-MB isoenzyme, troponin), participants developing ST segment changes or elevated cardiac markers were admitted. Those with a negative observation period underwent SMPI (N = 1,004) or clinical assessment (N = 504) based on randomization, and admitted if their SMPI scan was abnormal or senior clinicians found a high or intermediate risk for ACS. RESULTS: SMPI participants had a significantly lower admission rate than clinical assessment participants (10.16% vs 18.45%), with no significant between-group differences in risk of cardiac events (CEs) after 30 days (0.40% vs 0.79%) or 1 year (0.70% vs 0.99%). CONCLUSIONS: When added to a standard triage strategy incorporating clinical evaluation, serial ECGs, and cardiac markers, SMPI improved clinical decision making for chest pain patients, significantly reducing the need for hospitalization without an increase in adverse CE rates at 30 days or 1 year.

Dexamethasone for prevention of postoperative nausea and vomiting in patients undergoing thyroidectomy: meta-analysis of randomized controlled trials.

BACKGROUND: Postoperative nausea and vomiting (PONV) is a common complication after thyroidectomy. Steroids effectively reduce nausea, pain, and inflammation; therefore, preoperative administration of steroids ought to improve these surgical outcomes. METHODS: We conducted a systematic review of randomized controlled trials (RCTs) that compared preoperative single-dose administration of dexamethasone with no dexamethasone in patients undergoing thyroidectomy. The primary outcome was occurrence of PONV within 24 h, and the secondary outcomes were pain, use of analgesics, and steroid-related complications. RESULTS: Five RCTs were included with a total of 497 patients. A statistically and clinically significant difference in the incidence of PONV was found in favor of dexamethasone [relative risk (RR) 0.38; 95% confidence interval (CI) 0.30-0.49). The visual analog pain score was significantly diminished (weighted mean difference, WMD)-1.50; 95% CI-2.54 to -0.46) at 24 h. The incidence of analgesics use was also reduced (RR 0.61; 95% CI 0.41-0.90) in the dexamethasone group. No steroid-related complications were noted. CONCLUSIONS: A single preoperative administration of dexamethasone reduced the incidence of PONV and analgesic requirements in patients undergoing thyroidectomy. Prophylactic use of steroids for patients undergoing thyroidectomy is safe and should be considered for routine clinical practice.

The role of head-up cardiopulmonary resuscitation in sudden cardiac arrest: a systematic review and meta-analysis.

Background: Head-up cardiopulmonary resuscitation (HU-CPR) is an experimental treatment for sudden cardiac arrest (SCA), where cardiopulmonary resuscitation (CPR) is performed in a ramped position. We evaluated whether HU-CPR improved survival and surrogate outcomes as compared to standard CPR (S-CPR). Methods: Studies reporting on HU-CPR in SCA were searched for in PubMed, Embase and Cochrane Library from inception to May 1st 2021. Outcomes included neurologically-intact survival, 24-hour-survival, intracranial pressure (ICP), cerebral perfusion pressure (CerPP) and brain blood flow (BBF). Risk of bias was assessed using the GRADE assessment tool and Newcastle Ottawa Scale. Fixed- and random-effects models were used to estimate the pooled effects of HU-CPR at 30 degrees. Results: Thirteen articles met the criteria for inclusion (11 animal-only studies, one before-and-after human-only study, one study that utilized human- and animal-cadavers). Among animal studies, the most common implementation of HU-CPR was a 30-degree upward tilt of the head and thorax (n=7), while four studies investigated controlled sequential elevation (CSE). Two animal studies reported improved cerebral performance category (CPC) scores at 24-hour. The pooled effect on 24-hour survival was not statistically significant (P=0.37). The lone human study reported doubled return of spontaneous circulation (ROSC) (17.9% versus 34.2%, P<0.0001). The pooled effect on ROSC in three porcine studies was OR =3.63 (95% CI: 0.72-18.39). Pooled effects for surrogate physiological outcomes of intracranial cranial pressure (MD -14.08, 95% CI: -23.21 to -4.95, P=0.003), CerPP (MD 14.39, 95% CI: 3.07-25.72, P=0.01) and BBF (MD 0.14, 95% CI: 0.02-0.27, P=0.03), showed statistically significant benefit. Discussion: Overall, HU-CPR improved neurologically-intact survival at 24-hour, ROSC and physiological surrogate outcomes in animal models. Despite promising preclinical data, and one human observational study, clinical equipoise remains surrounding the role of HU-CPR in SCA, necessitating clarification with future randomized human trials.

Erratum to rapid advice guidelines for management of children with COVID-19.

[This corrects the article DOI: 10.21037/atm-20-3754.].

Meta-analysis comparing total hip arthroplasty with hemiarthroplasty in the treatment of displaced neck of femur fracture.

Displaced neck of femur fracture is a common clinical problem among the elderly population. Our aim is to review previously published randomized controlled trials to establish if total hip arthroplasty (THA) or hemiarthroplasty will offer a superior clinical outcome in this group of patients. We conducted literature search for relevant randomized controlled trials. A total of 407 patients from 3 trials were included in this meta-analysis. In the long-term follow-up, we found that THA patients were able to ambulate better, reported less pain compared with their hemiarthroplasty counterparts, and were less likely to undergo a repeated hip surgery. Considering the more favorable long-term outcomes in THA patients, we conclude that there may be a case to offer THA as the primary treatment of these patients.

The safest and most efficacious route of tranexamic acid administration in total joint arthroplasty: A systematic review and network meta-analysis.

INTRODUCTION: Blood loss in Total Joint Arthroplasty can be significant and often under-estimated. This study aims to investigate the safety and efficacy of different routes of tranexamic acid (TXA) administration in reducing blood transfusion after Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). The secondary aim is to find the safest and most efficacious route and dose of TXA. MATERIAL AND METHODS: PubMed, Embase, Cochrane library, China National Knowledge Infrastructure, and OpenGrey were systemically searched for randomised controlled trials investigating the efficacy and/or safety of TXA for THA and/or TKA. Network meta-analysis, comparing the number of transfusion and deep vein thrombosis (DVT) among different interventions, was performed using a multivariate meta-regression model with random-effects, adopting a frequentist approach. RESULTS: 211 publications (20,639 individuals) were included. For outcome of transfusion, all interventions showed significantly lower transfusion rates compared to placebo. When compared to placebo, TXA via intra-venous and topical showed statistically significant lowest risk ratio (RR = 0.11, 95CI: 0.03, 0.41). For safety, TXA via topical showed relatively lowest risk ratio (RR = 0.75, 95CI 0.44, 1.30). TXA via topical and intra-articular had the highest but statistically insignificant RR (RR = 1.10, 95%CI: 0.51, 2.38). Therefore, current studies did not reveal any significant safety issue in using TXA. CONCLUSION: All forms of TXA administration showed significantly lower transfusion rate compared to control. There is a trend towards better efficacy with intra-venous and topical. In patients with higher risk of thrombosis, physicians may consider topical alone for its best safety profile.

Diabetes Control: Is Vinegar a Promising Candidate to Help Achieve Targets?

BACKGROUND: Renewed interest in vinegar as a glucose-lowering agent led to several small trials in the recent past. However, none of the trials could independently provide sufficient evidence. OBJECTIVES: Our review aimed to obtain reliable estimates of effects of vinegar on short-term and long-term blood glucose control. METHODS: Large bibliographic databases were searched from inception to date of search without language and publication date restrictions. All clinical trials evaluating effect of vinegar on diabetes mellitus patients were eligible. Two authors independently extracted data on fasting and 2-hour postprandial blood glucose, insulin, and HbA1c levels at the various time points. MS Excel, SAS® v9.3, and RevMan v5.3 were used for data analysis. RESULTS: Small significant reduction in mean HbA1c was observed after 8 to 12 weeks of vinegar administration: -0.39% (95% confidence interval = -0.59, -0.18; I2 = 0%). Other long-term outcomes favored vinegar but were not significant. Short-term outcomes showed significantly lower pooled mean difference in glucose levels at 30 minutes in the vinegar group. Readings at 60, 90, and 120 minutes were lower in the vinegar group but not statistically significant. Adverse effects profile also favored the vinegar group. CONCLUSIONS: It is worthwhile to carry out carefully planned large trails to determine the efficacy and effectiveness of vinegar as an adjunct treatment modality.

Epidemiology of spondyloarthritis in the People's Republic of China: review of the literature and commentary.

OBJECTIVES: The prevalence of spondyloarthritis (SpA) and its prototype ankylosing spondylitis (AS) varies considerably in different parts of the world. With 20% of the world's population in China, there is potential for a significant disease burden. Eight of the 10 articles providing primary data on the prevalence of SpA in China are in the Chinese language; our objective is to review all 10 articles for English readers. METHODS: Articles were retrieved by search engines in both the English language (www.pubmed.gov) and Chinese language web sites (www.cnki.net). We limited our search to publications of the period 1994 to 2006, and the key words used were (entered as Chinese characters) "prevalence AND spondyloarthropathy," "prevalence AND ankylosing spondylitis," "epidemiology AND spondyloarthropathy," and "epidemiology AND ankylosing spondylitis." For each survey, we examined the number of subjects surveyed, the survey instrument, the criteria used for classifying patients as SpA or AS, and other methodological quality issues. RESULTS: There were 2 AS surveys in the military and 8 surveys in the civilian communities. Overall, the pooled prevalence of AS for the military and civilian communities is 0.24%, 95% confidence interval (CI: 0.17 to 0.32) and 0.23%, 95% CI (0.19 to 0.28), respectively. There is 1 SpA survey in the military and 4 surveys in the civilian communities. The prevalence of SpA in the military survey is 0.45%. The pooled prevalence of SpA from the civilian surveys is 0.93%, 95%CI (0.53 to 1.65). We found that the survey methodology is generally not well reported, giving rise to concerns about the methodological quality and hence validity of the results. CONCLUSION: The prevalence of AS and SpA in China are similar to Caucasians in the U.S. or Europe.

Effects of Aortic Valve Replacement on Severe Aortic Stenosis and Preserved Systolic Function: Systematic Review and Network Meta-analysis.

The survival benefits of aortic valve replacement (AVR) in the different flow-gradient states of severe aortic stenosis (AS) is not known. A comprehensive search in PubMed/MEDLINE, Embase, Cochrane Library, CNKI and OpenGrey were conducted to identify studies that investigated the prognosis of severe AS (effective orifice area ≤1.0 cm2) and left ventricular ejection fraction ≥50%. Severe AS was stratified by mean pressure gradient [threshold of 40 mmHg; high-gradient (HG) and low-gradient (LG)] and stroke volume index [threshold of 35 ml/m2; normal-flow (NL) and low-flow (LF)]. Network meta-analysis was conducted to assess all-cause mortality among each AS sub-type with rate ratio (RR) reported. The effects of AVR on prognosis were examined using network meta-regression. In the pooled analysis (15 studies and 9,737 patients), LF states (both HG and LG) were associated with increased mortality rate (LFLG: RR 1.88; 95% CI: 1.43-2.46; LFHG: RR: 1.77; 95% CI: 1.16-2.70) compared to moderate AS; and NF states in both HG and LG had similar prognosis as moderate AS (NFLG: RR 1.11; 95% CI: 0.81-1.53; NFHG: RR 1.16; 95% CI: 0.82-1.64). AVR conferred different survival benefits: it was most effective in NFHG (RR with AVR /RR without AVR : 0.43; 95% CI: 0.22-0.82) and least in LFLG (RR with AVR /RR without AVR : 1.19; 95% CI: 0.74-1.94).

Combined diagnostic performance of coronary computed tomography angiography and computed tomography derived fractional flow reserve for the evaluation of myocardial ischemia: A meta-analysis.

BACKGROUND: To evaluate the combined diagnostic accuracy of coronary computed tomography angiography (CCTA) and computed tomography derived fractional flow reserve (FFRct) in patients with suspected or known coronary artery disease (CAD). METHODS: PubMed, The Cochrane library, Embase and OpenGray were searched to identify studies comparing diagnostic accuracy of CCTA and FFRct. Diagnostic test measurements of FFRct were either extracted directly from the published papers or calculated from provided information. Bivariate models were conducted to synthesize the diagnostic performance of combined CCTA and FFRct at both "per-vessel" and "per-patient" levels. RESULTS: 7 articles were included for analysis. The combined diagnostic outcomes from "both positive" strategy, i.e. a subject was considered as "positive" only when both CCTA and FFRct were "positive", demonstrated relative high specificity (per-vessel: 0.91; per-patient: 0.81), high positive likelihood ratio (LR+, per-vessel: 7.93; per-patient: 4.26), high negative likelihood ratio (LR-, per-vessel: 0.30; per patient: 0.24) and high accuracy (per-vessel: 0.91; per-patient: 0.81) while "either positive" strategy, i.e. a subject was considered as "positive" when either CCTA or FFRct was "positive", demonstrated relative high sensitivity (per-vessel: 0.97; per-patient: 0.98), low LR+ (per-vessel: 1.50; per-patient: 1.17), low LR- (per-vessel: 0.07; per-patient: 0.09) and low accuracy (per-vessel: 0.57; per-patient: 0.54). CONCLUSION: "Both positive" strategy showed better diagnostic performance to rule in patients with non-significant stenosis compared to "either positive" strategy, as it efficiently reduces the proportion of testing false positive subjects.

The Association Between Built Environment Attributes and Physical Activity in East Asian Adolescents: A Systematic Review.

Asian adolescents living in Australia and England were found to be less active than their Western peers. We aimed to systematically examine evidence of the associations between attributes of the built environment and physical activity in adolescents dwelling in East Asian countries. A total of 10 electronic databases for relevant observational studies without time limit were searched. Five studies met the eligibility criteria, which involved a total of 43 817 schoolchildren aged 11 to 17 years. The majority of the built environment attributes measured was significantly associated with reported physical activity. Difficult access to public facilities was associated with physical inactivity. Inconsistent finding of the association between residential density and physical activity was found. Further studies comparing participants from different Asian countries using a longitudinal design with an appropriate period of follow-up and both objective and reported measures of built environment attributes and physical activity are needed.

Impact of Asia-Pacific guidelines on gastric cancer and Helicobacter pylori infection on prevailing clinical practices.

OBJECTIVE: To determine the impact of the Asia-Pacific guidelines on gastric cancer prevention and Helicobacter pylori (H. pylori) infection on clinical practice. METHODS: An electronic survey was carried out among Asian Pacific Digestive Week (APDW) medical delegates in 2012. The survey questionnaire captured details such as participants' characteristics, their awareness of the guidelines and knowledge of the key guideline recommendations, the impact of the guidelines on individual practice and on national policies and the sources of medical information that the individual used to make clinical decisions. A total of 1372 APDW medical delegates were invited via email to participate in the electronic survey and 432 (31.5%) responded. RESULTS: Among the respondents, 57.6% were familiar with at least one of the guidelines. Among those familiar with the guidelines, 85.9% believed that they influenced their clinical practice. More than half (64.9%) reported that the guidelines clarified treatment indications for them. In terms of knowledge content, 85.0% of the participants provided correct responses to at least four of the six questions on understanding. More than half (52.7%) of the participants felt that the guidelines had made an impact on national policies. CONCLUSION: The Asia-Pacific guidelines on gastric cancer and H. pylori had a positive impact on individual clinical practice and national policies.

Role of procalcitonin in infectious gastroenteritis and inflammatory bowel disease.

BACKGROUND AND AIM: We have evaluated procalcitonin (PCT) as a diagnostic marker for bacterial gastroenteritis (GE) and as a disease activity marker in inflammatory bowel disease (IBD) patients. METHODS: This was a prospective single-center study performed over a 1-year period. Venous blood samples were drawn from hospitalized patients with acute GE and tested for PCT, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and total white cell count (TWC); stools from the same patients were tested for standard pathogens. Venous blood samples from patients with IBD were tested for PCT, CRP, ESR, and platelet count. The PCT level was measured using an immunofluorescent assay, with normal being defined as <0.5 ng/ml. RESULTS: The GE arm of study consisted of 81 patients, 18.5% of whom were diagnosed with bacterial GE. The PCT and CRP levels were good diagnostic markers of bacterial GE, with an area under the curve (AUC) of 0.727 [95% confidence interval (CI) 0.580-0.874] and 0.786 (95% CI 0.627-0.946), respectively. An elevated PCT > or =0.5 ng/ml was associated with a 13-fold increased risk of renal impairment. The IBD arm of study consisted of 72 IBD patients. The PCT levels were not significantly different between active and inactive IBD in this patient cohort. CONCLUSION: Our results indicate that PCT and CRP are comparably good diagnostic markers of bacterial GE but that PCT is not useful as in monitoring disease activity in patients with IBD.