Participant and GP perspectives and experiences of screening for undiagnosed type 2 diabetes in community pharmacy during the Pharmacy Diabetes Screening Trial.

BACKGROUND: The Pharmacy Diabetes Screening Trial (PDST) evaluated three approaches to screening for undiagnosed type 2 diabetes mellitus (T2DM) in community pharmacy: (1) paper-based risk assessment (AUSDRISK) alone; and AUSDRISK followed by a point of care test if AUSDRISK ≥ 12; with either (2) HbA1c; or (3) small capillary blood glucose Test (scBGT). This paper reports the perspectives and experiences of the pharmacy screening service of two key stakeholder groups: screening participants and general practitioners (GPs). METHODS: All referred participants (n = 2242) received an online survey to determine the outcome of the referral, as well as their level of satisfaction with the service. In addition, a random sample of 2,989 (20%) of non-referred participants were surveyed to determine their overall experience and level of satisfaction with the service. GPs to whom participants were referred were contacted to establish if, since the date of the screening service, their patient had (1) been to see them; (2) had further tests performed (FBG, RBG, OGTT, HbA1c); or (3) been diagnosed with diabetes or prediabetes. Descriptive statistics were reported for quantitative data. Factors associated with visiting the GP following screening were assessed using multivariable logistic regression. Qualitative data were analysed using content analysis. RESULTS: Response rates 16% (n = 369) and 17% (n = 520) were achieved for the three-month referred and non-referred participant surveys, respectively. Over 90% of respondents were very positive about the screening service (n = 784/853) and would recommend it to a family member or friend (n = 784/853). Participants also reported making significant improvements in diet and exercise, because of the screening. Among referred respondents, those who received a POC test were twice as likely to visit their GP compared to those who received a risk assessment only (OR 2.11 95% CI 1.46-3.06). GPs (15.8% response rate, n = 57/361) indicated that the referral worked well and that recommendations for follow-up care by the pharmacist were appropriate. CONCLUSION: Opportunistic screening of individuals during routine encounters with the community pharmacy in a previously undiagnosed population has been shown to foster positive engagement with consumers and GPs, which may assist in reducing the burden of T2DM on the individual and the community.

Enhancing healthcare at home for older people in rural and regional Australia: A protocol for co-creation to design and implement system change.

BACKGROUND: World-wide, health service providers are moving towards innovative models of clinical home-based care services as a key strategy to improve equity of access and quality of care. To optimise existing and new clinical home-based care programs, evidence informed approaches are needed that consider the complexity of the health care system across different contexts. METHODS: We present a protocol for working with health services and their partners to perform rapid identification, prioritisation, and co-design of content-appropriate strategies to optimise the delivery of healthcare at home for older people in rural and regional areas. The protocol combines Systems Thinking and Implementation Science using a Consensus Mapping and Co-design (CMC) process delivered over five workshops. DISCUSSION: The protocol will be implemented with rural and regional healthcare providers to identify digital and non-digital solutions that have the potential to inform models of service delivery, improve patient experience, and optimise health outcomes. The combination of system and implementation science is a unique approach for optimising healthcare at home for older populations, especially in the rural context where need is high. This is the first protocol to integrate the use of systems and implementation science into one process and articulating these methods will help with replicating this in future practice. Results of the design phase will translate into practice through standard health service planning methods to enhance implementation and sustainability. The delivery of the protocol will include building capacity of health service workers to embed the design, implementation, and evaluation approach into normal practice. This protocol forms part of the DELIVER (Delivering Enhanced heaLthcare at home through optImising Virtual tools for oldEr people in Rural and regional Australia) Project. Funded by Australia's Medical Research Future Fund, DELIVER involves a collaboration with public health services of Western Victoria, Australia.

Global burden of early pregnancy gestational diabetes mellitus (eGDM): A systematic review.

AIMS: Gestational diabetes mellitus (GDM) diagnosed during the first trimester of pregnancy is called 'early pregnancy Gestational Diabetes Mellitus' (eGDM). The burden of eGDM has only been studied sporadically. This review aims to understand the global burden of eGDM in terms of prevalence, risk factors, pregnancy outcomes, treatment and postpartum dysglycemia.  METHODS: A review of epidemiologic studies reporting on early GDM screening as per Joanna Briggs Institute (JBI) methodology for prevalence reviews was conducted. A customized search strategy was used to search electronic databases namely, PubMed, CINAHL, EMBASE, Cochrane Library, Scopus, MEDLINE, Ovid, ScienceDirect, and Google Scholar. Three independent reviewers reviewed studies using Covidence software. Observational studies irrespective of study design and regardless of diagnostic criteria were included. Quality of evidence was appraised, and findings were synthesized. RESULTS: Of 58 included studies, 41 reported a prevalence of eGDM, ranging from 0.7 to 36.8%. Body mass index (BMI), previous history of GDM, family history of diabetes and multiparity were reported as eGDM risk factors. Adverse pregnancy outcomes associated with eGDM were macrosomia, caesarean delivery, induction of labour, hypertension, preterm delivery, and shoulder dystocia. The incidence of postpartum dysglycemia and the need for insulin was higher in women with eGDM. The risk of bias was moderate. Heterogeneity of studies is a limitation. Meta-analysis was not performed. CONCLUSIONS: There is heterogeneity in the prevalence of eGDM and intrapartum and postpartum ill effects for the mother and the offspring. There is a need to develop a universal screening protocol for eGDM.

Evaluation of rapid DNA using ANDE™ in a technical exploitation Level 2 laboratory workflow.

A trial of rapid DNA (rDNA), a fully automated DNA profiling system, within a technical exploitation (TE) workflow is an important endeavor. In the 2019 Ardent Defender (AD) exercise, the Deployable Technical Analysis Laboratory (DTAL), of the Canadian Department of National Defence (DND), evaluated the use of rDNA using ANDE™. Sixteen samples were processed during a pre-exercise "controlled" setting, 44 samples were from an "uncontrolled" environment during the exercise, and 22 samples were buccal swabs. The proportion of profiles suitable for upload to ANDE™ was 95.5% of buccal samples (21/22), 66.7% controlled samples, and 15.9% for uncontrolled samples. A considerable difference was observed in the proportions of complete DNA profiles obtained from all exploited items between the controlled (58.3%) and uncontrolled (15.9%) trials and in the proportions of samples where no DNA was detected (16.7% controlled trial vs. 56.8% uncontrolled trial). Overall, the trials highlighted the potential to gain identity intelligence using rDNA within a TE workflow and revealed the impact of operational constraints and the need to improve certain TE practices to gain the most benefit from rDNA. It also demonstrated the benefit of including an uncontrolled component for a more realistic indication of rDNA effectiveness in operational settings and highlighted operational practices impacting rDNA success. Mixture deconvolution was difficult as current guidelines do not consider some of the stochastic effects produced by the rDNA analysis; however, overall, the study demonstrated that rDNA using the ANDE™ instrument could be successfully incorporated into a TE workflow within a deployable laboratory.

Implementation of diabetes screening in community pharmacy - factors influencing successful implementation.

INTRODUCTION: Community pharmacists are increasingly providing a range of professional health services. Whilst research provides evidence of their benefits, knowledge translation into practice has been challenging both in Australia and internationally. An opportunity to develop a granular understanding of factors driving successful implementation was presented by the Pharmacy Diabetes Screening Trial (PDST), a clustered Randomised Controlled Trial (RCT) implemented in a random sample of 339 Australian community pharmacies. Its aim was to compare the clinical and cost effectiveness of three pharmacy-based diabetes screening interventions. OBJECTIVE: To investigate the experiences of Australian community pharmacists in the implementation of the PDST and factors influencing implementation success. METHODS: Semi-structured telephone interviews were conducted with a stratified sample of pharmacist trial participants based on screening performance (number screened relative to target), location, and trial arm. All interviews were audio-recorded and transcribed ad verbatim. Interviews were continued until saturation. Initial thematic analysis was followed by in-depth analysis to test the extent to which the data fitted with three previously described overarching themes driving successful national implementation of innovation in community pharmacy. RESULTS: From August 2017 to October 2017, 21 interviews were conducted; 12 with high-performing and 9 with low-performing pharmacists. The key enablers and barriers were qualities of a pharmacy champion and active staff engagement, ease of implementation related to the number of working pharmacists and other staff, the external context including engagement with consumers and doctors, and consumer demand. It was also identified that attitudes/emphasis towards implementation planning and conscious prioritisation of service delivery by pharmacists may have been key differences between high- and low-performing pharmacies. CONCLUSION: Insights into the interaction between individual, organisational, and external factors influencing successful implementation of community pharmacy innovations highlighted in this study should inform the design of future innovations to ensure their success and sustainability.

Protocol for a randomised controlled trial evaluating the impact of a community pharmacy discharge medication reconciliation service on unplanned hospital readmissions - The DCMedsRec trial.

INTRODUCTION: A substantial proportion of hospital admissions and readmissions are directly attributable to preventable medication-related harm. Interventions that reduce these harms could avert significant suffering and healthcare costs. OBJECTIVES: The Discharge Medications Reconciliation (DCMedsRec) trial will evaluate a structured medication reconciliation service by community pharmacists post hospital discharge on the risk of 30-day unplanned readmission. Electronic access to the Hospital Discharge Summary via My Health Record will underpin this service. METHODS: DCMedsRec is a non-blinded randomised controlled trial of an intervention by community pharmacists within 30 days of hospital discharge in Melbourne, Australia. Patients discharged from hospital will be assessed by a hospital pharmacist for trial eligibility. If eligible, patients will be randomised to either a control or intervention group by sequentially marked sealed envelopes. Intervention patients receive an invitation to the DCMedsRec service at a participating community pharmacy, who will be reimbursed. Control patients will receive usual care. A Number Needed to Treat of 20 will require 293 DCMedsRec interventions to achieve 80% power. With a predicted 30% uptake, a minimum sample of 977 in the intervention arm is required. OUTCOMES: The primary outcome will be the rate of 30-day unplanned hospital readmission in intervention (DCMedsRec) versus usual care groups. Secondary analyses will evaluate the economic impact of the intervention and a qualitative thematic analysis of the experience and value of the service for both patients and service providers (community pharmacists). ANALYSIS: An intention-to-treat analysis will be used to assess intervention efficacy and results will be reported using risk ratios with 95% confidence intervals. Cost-effectiveness analysis will compare within-trial costs and outcomes of the DCMedsRec versus usual care from a health-system perspective. TRIAL REGISTRATION AND FUNDING: This trial is registered with the Australian and New Zealand Clinical Trials Register and funded by the Australian Digital Health Agency.

Patient feedback for safety improvement in primary care: results from a feasibility study.

OBJECTIVES: Patient involvement in safety improvement is a developing area of research. The aim of this study was to investigate the feasibility of a patient feedback on safety intervention in primary care. Specifically, the intervention acceptability, fidelity, implementation enablers and barriers, scalability, and process of systematically collecting safety data were examined. DESIGN, SETTING AND PARTICIPANTS: Mixed-methods feasibility trial with six purposively selected Australian primary care practices. INTERVENTION: The intervention comprised an iterative process with a cycle of measurement, learning, feedback, action planning and implementation period of 6 months. PRIMARY AND SECONDARY OUTCOMES: Qualitative and quantitative data relating to feasibility measures (acceptability, fidelity, enablers, barriers, scalability and process of collecting safety data) were collected and analysed. RESULTS: A total of n=1750 patients provided feedback on safety. There was a statistically significant increase in mean patient safety scores indicating improved safety (4.30-4.37, p=0.002). Staff deemed the intervention acceptable, with minor recommendations for improvement. Intervention fidelity was high and implementation enablers were attributed to the intervention structure and framework, use of intuitive problem-solving approaches, and multidisciplinary team involvement. Practice-based safety interventions resulted in sustainable and measurable changes to systems for safety, such as increased access to care and improved patient information accuracy. CONCLUSIONS: The findings indicate that this innovative patient feedback on safety intervention is feasible for scale-up to a larger effectiveness trial and further spread into policy and practice. This intervention complements existing safety improvement strategies and activities, and integrates into current patient feedback service requirements for Australian primary care. Further research is needed to examine the intervention effects on safety incident reduction.

Metformin for Preventing Type 2 Diabetes Mellitus in Women with a Previous Diagnosis of Gestational Diabetes: A Narrative Review.

Women with a history of gestational diabetes mellitus (GDM) are at greater risk of developing type 2 diabetes mellitus (T2DM) when compared with women who have not had GDM. To delay or prevent T2DM, guidelines recommend regular screening in the primary care setting and lifestyle interventions that are largely focused on dietary and physical activity modifications. As the postpartum period can be challenging for women, uptake and engagement in screening and lifestyle interventions have been poor. Poor uptake and engagement places women with a history of GDM at heightened risk for future morbidity and development of T2DM. Metformin has been a longstanding and safe treatment for the control of blood glucose in people with T2DM. Research has supported the efficacy of metformin, used as an adjunct to a lifestyle intervention or as a stand-alone treatment, in preventing T2DM in people at high risk of T2DM. Findings from longitudinal studies have demonstrated the potential for metformin to reduce conversion to T2DM when used by women with a previous diagnosis of GDM. This review examines the potential effectiveness of metformin to reduce the incidence of T2DM among women with a previous diagnosis of GDM in the "real-world" setting.

Diabetes and cardiovascular disease risk screening model in community pharmacies in a developing primary healthcare system: a feasibility study.

OBJECTIVES: This study aimed to develop an evidence-based community pharmacist-delivered screening model for diabetes and cardiovascular disease (CVD), and assess its feasibility to identify and refer patients with elevated risk. DESIGN: A feasibility study. SETTING: A purposive sample of 12 community pharmacies in three cities in the United Arab Emirates (UAE). PARTICIPANTS: Adults 40 years of age and above who have not been previously diagnosed with either diabetes or CVD. INTERVENTION: Pharmacist screening of adults visiting pharmacies involved history, demographics, anthropometric measurements, blood pressure and point-of-care testing including glycated haemoglobin (HbA1c) levels and lipid panel. Participants with a 10-year CVD risk ≥7.5%, HbA1c level ≥5.7% or American Diabetes Association (ADA) risk score ≥5 points were advised to visit their physician. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were (1) development of UAE pharmacist-delivered screening model, (2) the proportion of screened participants identified as having high CVD risk (atherosclerotic CVD 10-year risk defined as ≥7.5%) and (3) the proportion of participants identified as having elevated blood glucose (high HbA1c level ≥5.7% (38.8 mmol/mol)) or high self-reported diabetes risk (ADA risk score ≥5 points). Secondary outcome is participants' satisfaction with the screening. RESULTS: The first UAE pharmacist-delivered screening model was developed and implemented. A total of 115 participants were screened, and 92.3% of the entire screening process was completed during a single visit to pharmacy. The mean duration of the complete screening process was 27 min. At-risk individuals (57.4%) were referred to their physicians for further testing, while 94.5% of participants were at least satisfied with their screening experience. CONCLUSIONS: The community pharmacist-delivered screening of diabetes and CVD risk is feasible in the UAE. The model offers a platform to increase screening capacity within primary care and provides an opportunity for early detection and treatment. However, pathways for the integration of the pharmacist-delivered screening service with physicians in primary care are yet to be explored.

Investigating the feasibility of a patient feedback tool to improve safety in Australian primary care: a study protocol.

INTRODUCTION: Patients are a valuable source of information about ways to prevent harm in healthcare, and can provide feedback about the factors that contribute to safety incidents. The Primary Care Patient Measure of Safety (PC PMOS) is a novel and validated tool that captures patient feedback on safety and can be used by primary care practice teams to identify and prevent safety incidents. The aim of this study is to assess the feasibility of PC PMOS as a tool for data-driven safety improvement and monitoring in Australian primary care. METHODS AND ANALYSIS: Feasibility will be assessed using a mixed-methods approach to understand the enablers, barriers, acceptability, practicability, intervention fidelity and scalability of C PMOS as a tool for safety improvement across six primary care practices in the south-west region of Victoria. Patients over the age of 18 years attending their primary care practice will be invited to complete the PC PMOS when presenting for an appointment. Staff members at each practice will form a safety improvement team. Staff will then use the patient feedback to develop and implement specific safety interventions over a 6-month period. Data collection methods during the intervention period includes audio recordings of staff meetings, overt observations at training and education workshops, reflexive researcher insights, document collection and review. Data collection postintervention includes patient completion of the PC PMOS and semistructured interviews with staff. Triangulation and thematic analysis techniques will be employed to analyse the qualitative and content data. Analysis methods will use current evidence and models of healthcare culture, safety improvement and patient involvement in safety to inform the findings. ETHICS AND DISSEMINATION: Ethics approval was granted by Deakin University Human Ethics Advisory Group, Faculty of Health (HEAG-H 175_2017). Study results will be disseminated through local and international conferences and peer-reviewed publications.

Capacity Building through Water Quality and Safety Analyses in Herat, Afghanistan.

Contaminated water is a leading cause of approximately 600 million annual cases of foodborne disease globally. Twenty percent of all child mortality in Afghanistan is attributed to diarrheal diseases. There are limited data on water quality and safety in Afghanistan as well as limited laboratory capacity for food and water analyses. The purpose of this study was to conduct a regional water assessment study and, in doing so, train the first class of food technology undergraduate students at Herat University (Herat City, Afghanistan) in basic water quality and safety laboratory techniques. In total, 235 water samples from private wells ( n = 128) and municipal water system taps ( n = 107) were collected from Herat Province, Afghanistan. Samples were aseptically collected, transferred, and analyzed at the Herat University Food Technology Laboratory for nitrate, nitrite, lead, phosphate, and arsenic concentrations; hardness; total coliforms; and Escherichia coli. We did not detect arsenic in any sample tested ( n = 234), and lead levels in samples tested ( n = 28) were below the U.S. Environmental Protection Agency maximum contaminant level (15 µg/L). In contrast, 38 of 232 samples had nitrate (NO3) levels greater than the maximum contaminant level (10 mg/L) and 15 of 232 samples had nitrite (NO2) levels > 0.3 mg/L. On average, well water was harder than municipal water; there were no differences in phosphate (PO4) levels. Furthermore, 93 (43.9%) of 212 samples had detectable coliforms (average CFU/100 mL) and 52 (24.3%) of 214 samples had detectable E. coli (average 28.6 CFU/100 mL). E. coli was detected in 21.4 and 26.7% of municipal and well water samples, respectively. This study indicates a clear need for systematic analyses of Herat City water to develop plans for water quality and safety improvement and management. The students engaged in the research project now have the basic research and analytical skills needed to address water and foodborne disease issues endemic in the area.

Prevalence, Safety, and Effectiveness of Oral Anticoagulant Use in People with and without Dementia or Cognitive Impairment: A Systematic Review and Meta-Analysis.

BACKGROUND: Differences in management and outcomes of oral anticoagulant (OAC) use may exist for people with and without dementia or cognitive impairment (CI). OBJECTIVE: To systematically review the prevalence and safety and effectiveness outcomes of OAC use in people with and without dementia or CI. METHODS: MEDLINE, EMBASE, and CINAHL were searched for studies reporting prevalence or safety and effectiveness outcomes of OAC use for people with and without dementia, published between 2000 to September 2017. Study selection, data extraction, and quality assessment were performed by two reviewers. RESULTS: studies met pre-specified inclusion criteria (21 prevalence studies, 6 outcomes studies). People with dementia had 52% lower odds of receiving OAC compared to people without dementia. Mean OAC prevalence was 32% for people with dementia, compared to 48% without dementia. There was no difference in the composite outcome of embolic events, myocardial infarction, and all-cause death between dementia and non-dementia groups (adjusted hazard ratio (HR) 0.72, 95% CI, 0.45-1.14, p = 0.155). Bleeding rate was lower for people without dementia (HR 0.56, 95% CI, 0.37-0.85). Adverse warfarin events were more common for residents of long-term care with dementia (adjusted incidence rate ratio 1.48, 95% CI, 1.20-1.82). Community-dwelling people with dementia treated with warfarin had poorer anticoagulation control than those without dementia (mean time in therapeutic range (TTR) % ±SD, 38±26 (dementia), 61±27 (no dementia), p < 0.0001). CONCLUSION: A lower proportion of people with dementia received oral anticoagulation compared with people without dementia. People with dementia had higher bleeding risk and poorer anticoagulation control when treated with warfarin.

Quality and safety attributes of afghan raisins before and after processing.

Raisins are an important export commodity for Afghanistan; however, Afghan packers are unable to export to markets seeking high-quality products due to limited knowledge regarding their quality and safety. To evaluate this, Afghan raisin samples from pre-, semi-, and postprocessed raisins were obtained from a raisin packer in Kabul, Afghanistan. The raisins were analyzed and compared to U.S. standards for processed raisins. The samples tested did not meet U.S. industry standards for embedded sand and pieces of stem, total soluble solids, and titratable acidity. The Afghan raisins did meet or exceed U.S. Grade A standard for the number of cap-stems, percent damaged, crystallization levels, moisture content, and color. Following processing, the number of total aerobic bacteria, yeasts, molds, and total coliforms were within the acceptable limits. Although quality issues are present in the Afghan raisins, the process used to clean the raisins is suitable to maintain food safety standards.

Shared decision making: what do clinicians need to know and why should they bother?

Shared decision making enables a clinician and patient to participate jointly in making a health decision, having discussed the options and their benefits and harms, and having considered the patient's values, preferences and circumstances. It is not a single step to be added into a consultation, but a process that can be used to guide decisions about screening, investigations and treatments. The benefits of shared decision making include enabling evidence and patients' preferences to be incorporated into a consultation; improving patient knowledge, risk perception accuracy and patient-clinician communication; and reducing decisional conflict, feeling uninformed and inappropriate use of tests and treatments. Various approaches can be used to guide clinicians through the process. We elaborate on five simple questions that can be used: What will happen if the patient waits and watches? What are the test or treatment options? What are the benefits and harms of each option? How do the benefits and harms weigh up for the patient? Does the patient have enough information to make a choice? Although shared decision making can occur without tools, various types of decision support tools now exist to facilitate it. Misconceptions about shared decision making are hampering its implementation. We address the barriers, as perceived by clinicians. Despite numerous international initiatives to advance shared decision making, very little has occurred in Australia. Consequently, we are lagging behind many other countries and should act urgently.

Evaluation of a fully covered self-expanding metal stent with flared ends in malignant biliary obstruction: a multicenter study.

BACKGROUND AND AIMS: Limited data are available regarding fully covered metal stents in the management of malignant distal biliary strictures. The aim of this study was to evaluate the safety of a fully covered self-expanding metal stent (FCSEMS) with flared ends, in treating malignant biliary strictures. We report our long-term retrospective analysis from 6 centers. METHODS: A total of 260 patients (142 males, median age 68 y) underwent endoscopic retrograde cholangiopancreatography with placement of FCSEMS (WallFlex; Boston Scientific, Natick, MA) for the palliation of obstructive jaundice in the setting of pancreatic adenocarcinoma (169), metastatic disease (36), cholangiocarcinoma (23), ampullary cancer (19), or other (13). Patients were evaluated clinically in follow-up and biochemical tests of liver function were obtained. Data were recorded for the following variables: patient survival, duration of stent patency, the need for subsequent biliary intervention, and complications. RESULTS: A total of 266 FCSEMS were placed in 260 patients. There was a median survival of 100 days (range, 7 to 531 d). There was a mean follow-up of 134±118 days (range, 4 to 519 d). Biliary decompression was successful in 252 patients (97%). At the end of the study period, 121 were alive with a patent stent, 65 patients died with a patent stent, 40 patients were successfully bridged to surgery, 8 patients had their patent stent removed and had no need for further stenting, and 18 patients were lost to follow-up. Five patients who had a successfully placed FCSEMS were considered a failure due to the following reason: migration (2), cholangitis (1), stent occlusion (1), and removal for management of proximal biliary obstruction (1). Two additional patients experienced migration that did not require FCSEMS removal or replacement. Stent replacement was required in 10 patients, of whom 6 had a second FCSEMS placed. The remaining 4 were in the failure group and underwent replacement with either uncovered stents or plastic stents. Other complications, managed conservatively, included pain (2), postendoscopic retrograde cholangiopancreatography pancreatitis (4), fever (1), retroperitoneal perforation (1), and postsphincterotomy bleeding (1). The mean patency duration was 328 days (SE 19.04). The patency percentage was 83% at 3 months, 63% at 6 months, and 48.5% at 12 months. CONCLUSIONS: In the management of malignant distal biliary strictures, the fully covered WallFlex stent has acceptable patency and complication rates. Further long-term prospective data are required to confirm this observation.

Multicenter trial evaluating the use of covered self-expanding metal stents in benign biliary strictures: time to revisit our therapeutic options?

BACKGROUND: Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS. AIM: : To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS. PATIENTS AND METHODS: Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study.Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications. RESULTS: A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)]. CONCLUSIONS: FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.

Hypoxemia in healthy subjects at moderate altitude.

BACKGROUND: Healthy individuals are known to have significantly reduced oxygen saturations at rest when acutely exposed to moderate altitudes, such as during commercial flight. There is a paucity of data on the response of healthy individuals to exercise at these altitudes. The aim of this study was to establish the normal response to exercise during acute, moderate altitude exposure with regard to oxygen saturations. Secondary aims were to establish if this response can be predicted from pulmonary function measurements at sea level. METHODS: At sea level, 20 subjects performed pulmonary function tests, including submaximal steady state exercise, followed by replication of submaximal steady state exercise during acute altitude exposure at 6844 ft (2086 m). RESULTS: Mean resting oxygen saturation at 6844 ft (2086 m) was 96%, a significant reduction from the sea level value of 99%. Mean nadir oxygen saturation during steady state exercise at moderate altitude was 89%. There was a weak negative correlation between aerobic capacity and end exercise oxygen saturation at altitude. Modified BORG dyspnea scores were unchanged at rest at 6844 ft (2086 m) and higher post-exercise at 6844 ft (2086 m) when compared to sea level, although absolute values were low. DISCUSSION: Healthy individuals desaturate at rest and upon exercise during acute altitude exposure at 6844 ft (2086 m). A quarter of participants experienced SpO2 < or = 85% upon exercise at altitude, although this had no correlation with dyspnea scores or baseline pulmonary function measurements. The weak negative correlation between aerobic capacity and end exercise oxygen saturation is unexplained and merits further research.