Search

Purpose MR-linacs (MRLs) have enabled the use of stereotactic magnetic resonance (MR) guided online adaptive radiotherapy (SMART) across many cancers. As data emerges to support SMART, uncertainty remains regarding optimal technical parameters, such as optimal patient positioning, immobilization, image quality, and contouring protocols. Prior to clinical implementation of SMART, we conducted a prospective study in healthy volunteers (HVs) to determine optimal technical parameters and to develop and practice a multidisciplinary SMART workflow. Methods HVs 18 years or older were eligible to participate in this IRB-approved study. Using a 0.35 T MRL, simulated adaptive treatments were performed by a multi-disciplinary treatment team in HVs. For each scan, image quality parameters were assessed on a 5-point scale (5 = extremely high, 1 = extremely poor). Adaptive recontouring times were compared between HVs and subsequent clinical cases with a t-test. Results 18 simulated treatments were performed in HVs on MRL. Mean parameters for visibility of target, visibility of nearby organs, and overall image quality were 4.58, 4.62, and 4.62, respectively (range of 4–5 for all measures). In HVs, mean ART was 15.7 min (range 4–35), comparable to mean of 16.1 (range 7–33) in the clinical cases (p = 0.8963). Using HV cases, optimal simulation and contouring guidelines were developed across a range of disease sites and have since been implemented clinically. Conclusions Prior to clinical implementation of SMART, scans of HVs on an MRL resulted in acceptable image quality and target visibility across a range of organs with similar ARTs to clinical SMART. We continue to utilize HV scans prior to clinical implementation of SMART in new disease sites and to further optimize target tracking and immobilization. Further study is needed to determine the optimal duration of HV scanning prior to clinical implementation.

Purpose\ud UK primary care provides a rich data source for research. The impact of proposed data collection restrictions is unknown. This study aimed to assess the impact of restricting the scope of electronic health record (EHR) data collection on the ability to conduct research. The study estimated the consequences of restricted data collection on published Clinical Practice Research Datalink studies from high impact journals or referenced in clinical guidelines.\ud \ud Methods\ud A structured form was used to systematically analyse the extent to which individual studies would have been possible using a database with data collection restrictions in place: (1) retrospective collection of specified diseases only; (2) retrospective collection restricted to a 6‐ or 12‐year period; (3) prospective and retrospective collection restricted to non‐sensitive data. Outcomes were categorised as unfeasible (not reproducible without major bias); compromised (feasible with design modification); or unaffected.\ud \ud Results\ud Overall, 91% studies were compromised with all restrictions in place; 56% studies were unfeasible even with design modification. With restrictions on diseases alone, 74% studies were compromised; 51% were unfeasible. Restricting collection to 6/12 years had a major impact, with 67 and 22% of studies compromised, respectively. Restricting collection of sensitive data had a lesser but marked impact with 10% studies compromised.\ud \ud Conclusion\ud EHR data collection restrictions can profoundly reduce the capacity for public health research that underpins evidence‐based medicine and clinical guidance. National initiatives seeking to collect EHRs should consider the implications of restricting data collection on the ability to address vital public health questions.

[See related article at [www.cmaj.ca/lookup/doi/10.1503/cmaj.191075][2]][2] A 37-year-old man with HIV infection (CD4+ cell count 706 cells/μL, viral load undetectable) presented with a 3-month history of cough, pharyngitis, low-grade fevers and dark black hemoptysis. A rash had also developed

Introduction In England there has been a substantial increase in the use of immediate implant-based reconstruction, accounting for over half of all immediate reconstructions (IR). Less than one third of patients in England undergo autologous reconstruction IR. Our aim was to examine IR trends in Scotland. Methods Data was extracted from the Scottish Morbidity Record held at the Information Services Division of the NHS National Services Scotland. All patients discharged from Scottish hospitals between 2011 and 2016 who had a diagnosis of breast cancer including DCIS and underwent mastectomy were identified. Patients undergoing IR were identified by coding at the time of mastectomy to identify who had IR and what method was used. Results Between 2011 and 2016, 7358 patients underwent a mastectomy for breast cancer. 1845 patients (25%) had an IR. The percentage of patients undergoing IR increased from 22% in 2011 to 26% in 2016. The dominant annual procedure type was autologous reconstruction (free flap and pedicled flaps), accounting for 58% in 2011 and 54% in 2016. Pedicled flaps alone decreased from 40% in 2011 to 28% in 2016 and free flaps increased from 18% in 2011 to 26% in 2016. Implant based reconstruction rates were broadly consistent, 37% in both 2011 and 2016. Pedicled flaps with implant reconstruction decreased from 13% in 2011 to 5% in 2016. Conclusions Autologous reconstruction (with increasing trend for free flaps procedures) remains a constant preferred technique for IR in Scotland, accounting for over half of IR performed.

Background Prevention and control of methicillin-resistant Staphylococcus aureus (MRSA) infections remain challenging. In-depth surveillance integrating patient and isolate data can provide evidence to better inform infection control and public health practice. Methods We analyzed MRSA cases diagnosed in 2010 (n = 212) and 2016 (n = 214) by hospitals in Ontario, Canada. Case-level clinical and demographic data were integrated with isolate characteristics, including antimicrobial resistance (AMR), classic genotyping, and whole-genome sequencing results. Results Community-associated MRSA (epidemiologically defined) increased significantly from 23.6% in 2010 to 43.0% in 2016 (P 2-fold increase in fusidic acid resistance (9.0% to 22.5%, P Conclusions Community-associated MRSA is increasing among hospitalized individuals in Ontario. Clonal shifting from CC5 to CC8 has impacted AMR. We identified a relatively high genetic diversity and limited genomic clustering within these dominant CCs.

This study investigated the effect of low-volume self-regulated high-intensity interval training (SR-HIIT) on cardiorespiratory fitness (CRF), exercise enjoyment, and intentions to repeat. Ten untrained, physically active adults (five males and five females, age: 20.3 ± 0.5 years) undertook a 2-week control period followed by 2-weeks SR-HIIT (6 x 10 min cycle ergometer sessions). Sessions involved alternate bouts at a rating of perceived exertion of 17 (work) and 11 (recovery), with bout durations self-regulated by the participant. Maximal aerobic capacity showed a small increase from post-control (3.14 ± 1.03 L.min-1 34 ) to post-training (3.45 ± 1.14 L.min-1; Xdiff 0.31, 95%CI 0.06 L.min-1, d = 0.28, 95%CL 0.11, 0.45). First ventilatory threshold showed a large increase from post-control (65.6 ± 2.1% V̇ O2max) to post-training (68.0 ± 2.4% V̇ O2max; Xdiff 2.4, 95%CI 1.2%, d = 0.96, 95%CL 0.27, 1.62). Post-exercise enjoyment showed small (Xdiff 3.5, 95%CI 8.1 AU, d = 0.31) and medium (Xdiff 6.9, 95%CI 6.7 AU, d = 0.68) increases from SR-HIIT session 1-3 and 3-6, respectively. There were trivial to medium increases in intention to repeat SR-HIIT once per week (d = 0.06 to 0.63) and three times per week (d = 0.28 to 0.60). Low-volume SR-HIIT elicits meaningful improvements in CRF, is enjoyable, and facilitates good intentions to repeat, and may be an additional option for implementing HIIT to improve general population health and fitness.

The aim of oncoplastic breast conservation (OBC) is to maintain quality of life with an acceptable breast appearance without compromising on oncological effectiveness. For many patients OBC offers an alternative to mastectomy. Despite the widespread adoption of OBC, there is limited high-quality evidence to support the oncological safety of this approach. Randomised trials are unlikely to happen given the complex ethical issues involved in patient choice for surgery. In this chapter, which includes a literature review of the best current available evidence, the key issues regarding oncological safety in OBC are discussed including preoperative planning; tumour resection margins and re-excision rates; local recurrence and patient outcome; and postoperative complications, adjuvant therapy delivery and postoperative surveillance. OBC is an integral part of breast surgery. Preoperative planning within a multidisciplinary setting considering tumour burden, tumour biology and patient selection for OBC technique is required to optimise patient outcomes. OBC allows extensive resections, and subsequently the incidence of positive margins is likely reduced but not ablated. Long-term local and distant recurrence highlights the importance of comparing ‘like with like’ and based on the current evidence OBC is a safe oncological approach even for patients with larger tumours. OBC involves more complex often, lengthy procedures and complications are expected; however, in most cases this does not result in delays to adjuvant therapy. Postoperative surveillance does not appear to be affected, although higher rates of biopsy may be expected.

Background This study aims to assess the quantity and quality of available literature on surgical treatment outcomes of spinal stenosis in adult and paediatric achondroplasia patients through a systematic review of literature and to investigate the suitability of conducting a meta-analysis on outcomes of surgical treatment. Methods Online databases were searched according to PRISMA guidelines. No restrictions regarding study design, sample size, previous treatment, or publication date were implemented. The following terms: “Spinal stenosis”, “Spinal Decompression”, “Spinal fusion”, each term separately combined with the term “Achondroplasia” were used. Quality of the included studies were assessed used the Modified Coleman method. Results Five adult and four paediatric single-sample non-comparative studies were identified for inclusion (176 adult and 102 paediatric patients). Meta-analyses assessed the proportion of patients achieving full resolution of symptoms to be 0.51 (95% CI 0.00 to 1.00); the proportion of patients achieving full or partial resolution of symptoms to be 0.90 (95% CI 0.84 to 0.97); the proportion of procedures requiring re-operation to be 0.42 (95% CI 0.34 to 0.50; and the proportion of procedures involving dural tears to be 0.20 (95% CI 0.02 to 0.39). Statistical heterogeneity was very high for full resolution of symptoms and requirement for dural repair; and very low for other outcomes. Conclusions The available literature on this population and condition is sparse, highly heterogenous, and is generally of low quality limiting the value of meta-analysis. Overall, outcomes of surgical decompression of symptomatic spinal stenosis in achondroplasia patients show consistent degree of resolution of symptoms. Duration of symptoms prior to surgical treatment appears to play an important role in the overall outcome of treatment. Therefore, a delay in diagnosis and treatment can potentially be detrimental in achieving a better outcome.

Innovations in suturing devices have facilitated sacrospinous ligament fixation (SSF) for the correction of vaginal vault prolapse. It is uncertain if outcomes using suturing devices differ from those using a traditional suturing technique. We hypothesize that no difference exists in the efficacy and safety 1 year after SSF for vault prolapse performed with suturing devices or using a traditional technique. The objective was to compare SSF using a suturing device with traditional SSF for the treatment of vault prolapse, regarding symptoms of prolapse recurrence, patient satisfaction, incidence of re-operation, and complications 1 year postoperatively. We carried out a retrospective cohort study using register-based national data from 2006 to 2013. The Swedish Quality Register of Gynecological Surgery includes assessments pre-operatively, at hospital admittance, surgery, discharge, and questionnaires at 8 weeks and 1 year after surgery. Demographic variables and surgical methods were included in multivariate logistic regression analyses. In the suturing device group (SDG, n = 353), 71.5% were asymptomatic of recurrence after 1 year compared with 78.7% in the traditional SSF group (TSG, n = 195); risk difference − 7.3% (95%CI −15.2%; 0.7%). Adjusted odds ratio (aOR) for being asymptomatic 1 year postoperatively was 0.56 (95%CI 0.31; 1.02, p = 0.057). Patient satisfaction was similar in SDG and TSG (78.1% vs 78.4%). Reoperation occurred in 7.4% in the SDG compared with 3.6% in the TSG, risk difference 3.8% (95%CI 0.0%; 7.5%), aOR 3.55 (95%CI 1.10; 11.44, p = 0.03). Patient satisfaction was similar 1 year after SSF, despite symptoms of recurrence being more likely and reoperation more common after using a suturing device compared with a traditional technique. The methods did not differ with regard to surgical complications.

Background: Bloodstream infections (BSIs) due to methicillin-resistant Staphylococcus aureus (MRSA) are important causes of morbidity and mortality in hospitalized patients. Long-term national MRSA BSI surveillance establishes rates for internal and external comparison and provide insight into epidemiologic, molecular, and resistance trends. Here, we present and discuss National MRSA BSI incidence rates and trends over time in Canadian acute-care hospitals from 2008 to 2018. Methods: The Canadian Nosocomial Infection Surveillance Programme (CNISP) is a collaborative effort of the Association of Medical Microbiology and Infectious Disease Canada and the Public Health Agency of Canada. Since 1995, the CNISP has conducted hospital-based sentinel surveillance of MRSA BSIs. Data were collected using standardized definitions and forms from hospitals that participate in the CNISP (48 hospitals in 2008 to 62 hospitals in 2018). For each MRSA BSI identified, the medical record was reviewed for clinical and demographic information and when possible, 1 blood-culture isolate per patient was submitted to a central laboratory for further molecular characterization and susceptibility testing. Results: From 2008 to 2013, MRSA BSI rates per 10,000 patient days were relatively stable (0.60–0.56). Since 2014, MRSA BSI rates have gradually increased from 0.66 to 1.05 in 2018. Although healthcare-associated (HA) MRSA BSI has shown a minimal increase (0.40 in 2014 to 0.51 in 2018), community-acquired (CA) MRSA BSI has increased by 150%, from 0.20 in 2014 to 0.50 in 2018 (Fig. 1). Laboratory characterization revealed that the proportion of isolates identified as CMRSA 2 (USA 100) decreased each year, from 39% in 2015 to 28% in 2018, while CMRSA 10 (USA 300) has increased from 41% to 47%. Susceptibility testing shows a decrease in clindamycin resistance from 82% in 2013 to 41% in 2018. Conclusions: Over the last decade, ongoing prospective MRSA BSI surveillance has shown relatively stable HA-MRSA rates, while CA-MRSA BSI rates have risen substantially. The proportion of isolates most commonly associated with HA-MRSA BSI (CMRSA2/USA 100) are decreasing and, given that resistance trends are tied to the prevalence of specific epidemic types, a large decrease in clindamycin resistance has been observed. MRSA BSI surveillance has shown a changing pattern in the epidemiology and laboratory characterization of MRSA BSI. The addition of hospitals in later years that may have had higher rates of CA-MRSA BSI could be a confounding factor. Continued comprehensive national surveillance will provide valuable information to address the challenges of infection prevention and control of MRSA BSI in hospitals.Funding: NoneDisclosures: None

Background Although lung volume reduction surgery (LVRS) improves survival in appropriately selected patients with COPD, few procedures are performed. The National Institute for Health and Care Excellence has recommended a more systematic approach to identifying potential candidates. We investigated LVRS referrals from a UK primary care population and aimed to establish an accurate estimate of eligible patients and determine a strategy for identifying potential candidates systematically. Methods Clinical Practice Research Datalink GOLD (a primary care database) and the linked Hospital Episode Statistics inpatient and Diagnostic Imaging Dataset were used. Patients with COPD who had undergone LVRS, patients who met basic eligibility criteria for further screening for LVRS, and patients meeting a more stringent eligibility criteria were identified from April 2012 to September 2015. Thoracic CT scan, pulmonary rehabilitation status, referral to respiratory outpatient clinics, and acute exacerbation of COPD requiring hospitalization were compared between actual LVRS recipients and potentially eligible patients. Results Among the 73,697 patients with COPD included, 36 (0.05%) received LVRS, 5,984 (8.1%) met basic eligibility criteria, and 159 (0.2%) met more stringent eligibility criteria. LVRS recipients were younger (mean age ± SD, 64 ± 9.2 years) than the stringently eligible patients (mean age ± SD, 69 ± 8.9 years; P = .01). Few patients meeting stringent eligibility criteria (6.9%) had a CT scan of the thorax in the preceding 3 years or had been referred for assessment in secondary care. Conclusions A substantial unmet need exists among patients with COPD who could potentially benefit from a lung volume reduction procedure but who are not being investigated or referred to consider this possibility.

Uganda adopted the integrase inhibitor dolutegravir (DTG) as part its preferred first-line HIV treatment regimen in 2018. Prior to the national rollout, the Uganda Ministry of Health and Clinton Health Access Initiative (CHAI) launched a pilot study in July 2017 aimed at better understanding patients’ and prescribers’ experience and acceptability of DTG. Patients were enrolled in the study if they were newly initiating treatment or switched from an NNRTI regimen due to intolerance. Patients were followed up for 6 months after initiation onto DTG and acceptability and experiences were assessed through questionnaires at one-month and six-month follow-up visits. In addition to acceptability side effects of patients on DTG regimens were assessed. Analysis was conducted using MS Excel and SAS 9.4 and confidence intervals were adjusted for facility level clustering. A total of 365 patients from 6 study sites were enrolled in the study, of whom 50% were treatment-experienced and 50% treatment naïve. 325 patients completed the 6 months of follow-up. Survey results showed a high level of acceptability (more than 90%) of DTG-containing regimens for both categories of patients during the from one-month and six-months interviews. The rate of self-reported side effects amongst patients was 33% overall and higher for experienced (37%) than naïve (29%) patients at 6 months. Although frequencies declined between month-1 and month-6, the changes were not statistically significant. Almost all patients (94%) were virally suppressed at 6 months. Overall, the study findings showed a very high level of acceptability of Dolutegravir-based regimens across both experienced and naïve patients. The overall viral suppression rate in this cohort was 94% at six months of taking DTG-based regimen.

Background: Lung volume reduction surgery (LVRS) improves survival in appropriately selected COPD patients. There are ~15,000 eligible patients in the UK, but only ~100 operations occur each year[1]. We investigated LVRS referrals from a UK primary care population and aimed to identify potential candidates systematically. Methods: We conducted a cohort study from 1/4/12- 30/9/15 using Clinical Practice Research Datalink (CPRD) (a primary care database), linked to Hospital Episode Statistics (HES) inpatient and HES Diagnostic Imaging Dataset (DID). We compared COPD patients who had LVRS to patients potentially eligible who had not received LVRS; using a definition of eligibility of MRC dyspnoea score of 4/5 and FEV1 Results: We included 73,697 COPD patients. 36 (0.05%) had received LVRS during the study period. 3,555 (4.8%) patients were potentially eligible for LVRS based on our criteria. The LVRS population were younger (mean age:64 years, SD:9.2) compared to the potentially eligible patients (mean age:73 years, SD:9.2) (p Conclusions: For the first time in a UK primary care setting, we have quantified the disparity between COPD patients who have had LVRS, and those who are potentially eligible but not referred. This highlights the need for referral for CT scans, which are essential to improve access to this highly effective procedure. 1. McNulty W. BMJ Open Resp Res 2014;1:e000023.

In a public health crisis, experts (such as epidemiologists, public health officers, physicians and virologists) support key decision makers with advice in a highly dynamic, pressured, and time-sensitive context. Experts must process information (to provide advice) as quickly as possible, yet this must be balanced with ensuring the information is credible, reliable, and relevant. When an unexpected event occurs, it may lead to a gap between what is experienced and what was expected; sensemaking is a meaning creation process which is engaged to fill the gap. This research explores how experts engage in sensemaking during a public health crisis.

To prospectively compare radiologically created pigtail gastrostomy (PG), in which the tube is inserted directly through the abdominal wall, versus peroral image-guided gastrostomy (POG), in which the tube is inserted through the mouth. Pain profiles (primary outcome measure), fluoroscopy times, total room times, technical success, complications, and quality of life (QOL) were measured.Sixty patients were prospectively randomized to receive 14-F PG or 20-F POG tubes. All patients received prophylactically created gastrostomies before radiation therapy for head and neck squamous-cell carcinoma. Patients receiving palliative treatment were excluded, as were those with established pharyngeal obstruction. Pain was measured by numeric rating scale (NRS) scores for 6 weeks after the procedure and by intraprocedural fentanyl and midazolam doses and postprocedural 24-h morphine doses. Fluoroscopy times, total room times, technical success, complications up to 6 months, and gastrostomy-related QOL (using the Functional Assessment of Cancer Therapy-Enteral Feeding questionnaire) were determined.Fifty-six patients underwent the randomized procedure. The POG group required significantly higher intraprocedural midazolam and fentanyl doses (mean, 1.2 mg and 67 μg, respectively, for PG vs 1.9 mg and 105 μg for POG; P.001) and had significantly longer fluoroscopy times (mean, 1.3 min for PG vs 4.8 min for POG; P.0001). NRS scores, morphine doses, total room times, technical success, complication rates, and QOL did not differ significantly between groups. The one major complication, a misplaced PG in the peritoneal cavity, followed a technical failure of POG creation.Despite the differences in insertion technique and tube caliber, the measured outcomes of POG and PG are comparable.

Purpose The objective of the study was to assess the efficacy of ovarian artery embolization (OAE) treatment for symptomatic uterine leiomyomas. Methods A retrospective review of 17 patients who underwent OAE in conjunction with uterine artery embolization in a 6-year period (2006-2012) was performed. Ten patients had previous failed embolization, while 7 had not received any embolization therapy before. Percent uterine volume change, percent dominant fibroid volume change, and percent dominant fibroid infarction were assessed with magnetic resonance (MR) imaging. Resolution of menorrhagia, dysmenorrhea/pain, and bulk and/or pressure symptoms including urinary frequency were evaluated clinically. Change in menopausal state was also an outcome of interest. Results Mean MR imaging follow-up was performed 3 months post-OAE. MR images showed complete infarction in the majority of cases (64.7%; n = 11), with infarction rates of 90%-100% in 3 cases, 1 case with 30%-50% infarction, and 2 cases with 0%-10% infarction. Average uterine size reduction on MR was 32.3% (95% confidence interval [CI]: 22.5%-42.2%; P < .001). The average size reduction for the dominant fibroid was 42.4% (95% CI: 27.7%-57.0%; P = .01). The mean time to final follow-up visit was 11 months. At this point complete symptom resolution (menorrhagia, dysmenorrhea and bulk-related) was achieved in 82.4% (n = 14) of cases. At the final follow-up 11.8% (n = 2) of cases reported menopause. Conclusions We observed OAE to be an effective and safe adjunct to uterine artery embolization when hypertrophic ovarian artery(ies) require intervention. However, incomplete fibroid infarction of 23% remains a concern with a potential for long-term treatment failure. In addition, long-term effect on ovarian function is uncertain.

The aim of this inquiry was to ascertain the efficacy of a multi-modal model of short-term dramatherapy with women who had suffered domestic abuse. A small-scale study was carried out to compare women who received individual dramatherapy with women who received individual key worker intervention. The 15 women were assigned to either the experimental or the control group. The experimental group received up to 12 weekly dramatherapy sessions with a qualified dramatherapist and the control group received 12 weekly key worker sessions with an experienced domestic violence substance misuse worker. The CORE system was used for both groups to provide pre- and post-intervention scores to assess change. The findings from this study revealed that the women who received dramatherapy presented significant improvements in their CORE Outcome Measure (CORE-OM) scores compared to women who attended key worker sessions. Women in the control group also showed improvements but not to the same extent.

Background: Grapefruit juice impacts the metabolism of a number of drugs via inhibition of a variety of metabolic enzymes. This study evaluated the impact of grapefruit juice on the antiplatelet activity of a loading dose and 7 days of maintenance therapy with clopidogrel. Methods: Healthy volunteers participated in two separate treatment protocols. The first protocol included a single 300 mg loading dose of clopidogrel and the second protocol included maintenance therapy with clopidogrel 75 mg given for 7 consecutive days. In both protocols, subjects were randomized to take clopidogrel with grapefruit juice or with tap water. At 6 h after the loading dose and at 6 h after the last maintenance dose of clopidogrel, a P2Y 12 reaction unit (PRU) value using the VerifyNow ® P2Y12 assay was determined. A PRU value > 235 was defined as high on-treatment platelet reactivity (defined as clopidogrel hyporesponse). Results: Fourteen subjects completed the loading dose protocol while 17 subjects completed the maintenance dose protocol. Following administration of the loading dose, the mean PRUs with grapefruit juice and tap water were 235.2 (95% confidence interval (CI): 210.4-260.0) and 177.4 (95% CI: 141.6-213.2), respectively (P = 0.001). Following administration of the loading dose, the numbers of subjects with a PRU > 235 with grapefruit juice and tap water were 9 (64%) and 3 (21%), respectively (P = 0.05). In the maintenance dose protocol, the mean PRUs with grapefruit juice and tap water were 212.4 (95% CI: 175.8-249.0) and 186.1 (95% CI: 149.6-222.7), respectively (P = 0.059). In the maintenance dose protocol, the proportions of patients with a PRU > 235 with grapefruit juice and tap water were 9 (53%) and 4 (23%), respectively (P = 0.16). Discussion: Compared to tap water, grapefruit juice significantly increased the mean PRU in patients following a 300 mg loading dose of clopidogrel. The increase in mean PRU after 7 days of a 75 mg/day maintenance dose of clopidogrel was also increased by grapefruit juice, but the magnitude of the increase was not statistically significant. The proportion of subjects with high on-treatment platelet reactivity with clopidogrel after ingestion with grapefruit juice was not significant during either the loading or maintenance dose. The results of our study are insufficient to reach a valid conclusion concerning an interaction between clopidogrel and grapefruit juice. Cardiol Res. 2014;5(1):1-7 doi: http://dx.doi.org/ 10.14740 / cr307w

A baby girl was born overnight at 27 weeks’ gestation following spontaneous labour, weighing 940 g. She was the second child of healthy non-consanguineous parents. The fetal medicine team were involved. The 20-week ultrasound findings were: At birth, the baby had no respiratory effort, but responded well to bag mask inflation breaths. Clinical examination revealed (see figure 1): Figure 1 Photograph of the infant in her incubator, demonstrating bilateral talipes, clenched hands and clinodactyly, smooth philtrum and microstomia with fixed jaw. Her oxygen requirement increased to 100%, despite high-flow nasal …

OBJECTIVE: The objectives of this study were to determine (1) the association between body mass index (BMI) and acute injury and (2) the association between BMI and bone fracture in children. METHODS: Children 5 to 17 years old were recruited in the emergency department at the British Columbia Children's Hospital. Cases included children treated for an injury, and control subjects were children without an injury in the past 12 months. Participants were administered a questionnaire to derive average activity level and demographic data. Weight and height measurements were taken to calculate BMI. Bivariate and multivariate logistic regressions were used to estimate the odds of injury occurrence by BMI category and the impact of covariates. RESULTS: Logistical regression, after adjusting for age, sex, activity level, and income level, did not reveal an increased association between BMI and acute injury in overweight odds ratio (OR) = 0.90 (0.48-1.70) and obese OR = 1.18 (0.60-2.33) children. Secondary outcome analyses failed to show an increased association between BMI and fracture in overweight OR = 0.44 (0.12, 1.66) and obese OR = 1.02 (0.31, 3.32) children. CONCLUSIONS: This study did not find increasing BMI to be associated with increased acute injury or bone fracture in children. Language: en

BackgroundAsthma episodes and deaths are known to be seasonal. A number of reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation. A fall in prescription collection in the month of August has been observed, and was associated with an increase in the number of unscheduled contacts after the return to school in September.ObjectiveThe primary objective of the study was to assess whether or not a NHS-delivered public health intervention reduces the September peak in unscheduled medical contacts.DesignCluster randomised trial, with the unit of randomisation being 142 NHS general practices, and trial-based economic evaluation.SettingPrimary care.InterventionA letter sent (n = 70 practices) in July from their general practitioner (GP) to parents/carers of school-aged children with asthma to remind them of the importance of taking their medication, and to ensure that they have sufficient medication prior to the start of the new school year in September. The control group received usual care.Main outcome measuresThe primary outcome measure was the proportion of children aged 5–16 years who had an unscheduled medical contact in September 2013. Supporting end points included the proportion of children who collected prescriptions in August 2013 and unscheduled contacts through the following 12 months. Economic end points were quality-adjusted life-years (QALYs) gained and costs from an NHS and Personal Social Services perspective.ResultsThere is no evidence of effect in terms of unscheduled contacts in September. Among children aged 5–16 years, the odds ratio (OR) was 1.09 [95% confidence interval (CI) 0.96 to 1.25] against the intervention. The intervention did increase the proportion of children collecting a prescription in August (OR 1.43, 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month (OR 1.13, 95% CI 0.84 to 1.52). For the wider time intervals (September–December 2013 and September–August 2014), there is weak evidence of the intervention reducing unscheduled contacts. The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children collecting prescriptions in August as well as having scheduled contacts in the same month. These unscheduled contacts in September could be a result of the intervention, as GPs may have wanted to see patients before issuing a prescription. The economic analysis estimated a high probability that the intervention was cost-saving, for baseline-adjusted costs, across both base-case and sensitivity analyses. There was no increase in QALYs.LimitationThe use of routine data led to uncertainty in the coding of medical contacts. The uncertainty was mitigated by advice from a GP adjudication panel.ConclusionsThe intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children both collecting prescriptions and having scheduled contacts in August. After September there is weak evidence in favour of the intervention. The intervention had a favourable impact on costs but did not demonstrate any impact on QALYs. The results of the trial indicate that further work is required on assessing and understanding adherence, both in terms of using routine data to make quantitative assessments, and through additional qualitative interviews with key stakeholders such as practice nurses, GPs and a wider group of children with asthma.Trial registrationCurrent Controlled Trials ISRCTN03000938.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 93. See the HTA programme website for further project information.

Approximately 100,000 patients begin hemodialysis each year in the United States. Although an arteriovenous fistula or graft is the preferred method for long-term vascular access during hemodialysis, as these types of vascular access are the most reliable, approximately 30% of patients require the use of catheters to continue hemodialysis. Tunneled, cuffed hemodialysis catheters are discouraged for permanent vascular access because of their high rates of infection, morbidity and mortality, and thrombotic and technical complications. These catheters have a short functional life span and require medical intervention, often thrombolytic therapy, to treat the catheter malfunction. No thrombolytic agent is specifically indicated for the management of occluded hemodialysis catheters. Thus, we performed a systematic review to critically evaluate all available studies that examined the efficacy, safety, and cost of thrombolytic therapy for the management of dysfunctional hemodialysis catheters. Studies were included if they reported efficacy in a specific proportion of affected dysfunctional hemodialysis catheters; reported the proportion of patients experiencing an adverse outcome (especially bleeding); and described the type of catheter used, dose of thrombolytic agent, administration protocol, dwell time, definition of treatment success, time to follow-up for study end points, and sample size. Eighteen studies met the inclusion criteria. The mean ± SD success rate in clearing dysfunctional hemodialysis catheters was greatest with reteplase at 88 ± 4%, followed by alteplase at 81 ± 37% and tenecteplase at 41 ± 5%. Adverse effects associated with the use of these thrombolytic agents administered at low doses were extremely rare. No serious adverse bleeding events attributed to thrombolytic therapy were reported in any of the trials. Aliquotted reteplase from vials for intravenous use was the least costly thrombolytic agent. Thus, at centers that use high volumes of thrombolytics for dysfunctional hemodialysis catheters, reteplase is the thrombolytic agent of choice.

Obesity is a global epidemic and has become a critical issue in Gulf countries such as Kuwait. The objective of this study is to assess the factors that are associated with overweight and obesity among Kuwaiti adult men. Weights and heights of a random sample of 464 men and their companions were collected to obtain body mass index (BMI). The overall levels of overweight and obesity were 48.5% and 19.8%, respectively. Logistic regression analysis of significantly associated factors revealed that factors contributing to risk of overweight and obesity included increasing age, having an obese mother or brother(s) and/or other obese relatives, having a lower grade point average, not being physically active, and being in poor health. Having a higher income and feeling tired were risk factors for obesity only. Family history is an important predictor of overweight and obesity in Kuwaiti men; however, this study identified several modifiable factors. It is recommended that factors that contribute to the development of overweight and obesity in Kuwait be targeted with behavioral change and/or health education interventions.

Recombinant thrombolytic peptides are mainly represented by recombinant forms of tissue plasminogen activator (t-PA), a proteolytic enzyme that catalyzes the conversion of plasminogen into active plasmin, which then functions to dissolve clots. The three clinically relevant recombinant thrombolytic peptides are alteplase (t-PA), reteplase (r-PA), and tenecteplase (TNK). r-PA and TNK have been structurally modified from native t-PA to increase their half-life and fibrin specificity. Thrombolytics play an important role in several diseases, including ST-segment elevation myocardial infarction (STEMI), deep vein thrombosis (DVT) and pulmonary embolism (PE), ischemic stroke, and peripheral arterial disease. Thrombolytic therapy has evolved into an alternative treatment for STEMI, reserved predominantly for patients who do not have access to timely percutaneous coronary intervention. In patients with DVT/PE or arterial related critical limb ischemia, the use of thrombolytic therapy is limited to specific patient populations. Thrombolytic therapy is the treatment of choice for ischemic stroke in patients who presentor=3 hours following the onset of symptoms. Moreover, thrombolytic therapy is used to restore function to stenotized central venous access devices as well as occluded hemodialysis access grafts.

Twenty-three patients underwent endocardial radiofrequency ablation of atrial fibrillation (AF) during mitral valve procedures with a previously described left atrial lesion pattern. A temperature-controlled 7-coil surgical probe delivered 60-second lesions at 80 degrees C. The left atrial appendage was oversewn after ablation. Ages ranged from 28 to 88 years. Nineteen patients had chronic AF that was present for over 1 year in 74%; 12 patients had rheumatic mitral stenosis. Mean left atrial diameter was 5.4 +/- 0.7 cm. There was 1 operative death unrelated to the ablation, and no strokes or ablation-related complications were observed. At mean follow-up of 32.5 weeks, 86% of the 22 survivors were in sinus rhythm. All 18 patients with left atrial diameter6 cm are in sinus rhythm. All postoperative atrial flutter was transient, and no patients required subsequent transcatheter ablation. This lesion pattern is safe and effective when applied in the method described here. It appears to be a reasonable alternative to the complete Maze 3 lesion pattern in patients with mitral valve disease.

The insertion and maintanence of advanced vascular access devices is increasingly becoming the remit of advanced nurses. Understanding the potential for air embolism as a complication of this procedure, recognising and managing the signs and symptoms, and being able to apply preventative measures, are imperative to enhance patient safety. A range of outcomes can present from air embolism depending on the rate and volume of air entrained, from sub-clinical to death, so the application of expert knowledge and vigilance is essential to minimise risk. According the the available literature, supplemental oxygen administration appears to be the most effective treatment.

Helicobacter pylori has been cultured from the inflamed gastric mucosae of naturally infected cats; the lesions in H. pylori-infected cat stomachs mimic many of the features seen in H. pylori-infected human stomachs. To determine whether H. pylori-negative specific-pathogen-free cats with normal gastric mucosae were susceptible to colonization by this bacterium and whether gastritis developed after infections, four H. pylori-negative cats treated with cimetidine were orally dosed three times with 3 ml (1.5 x 10(8) CFU/ml) of H. pylori every 4 days. All four cats became persistently colonized as determined by gastric cultures and PCRs from serial gastric biopsy samples and necropsy samples at 7 months postinfection. H. pylori was not isolated from the two control cats, nor were their gastric tissues positive by PCR; one of the two cats had a few focal lymphocytic aggregates in the body submucosa, whereas the second cat had a normal gastric mucosa. All four H. pylori-infected cats had multifocal gastritis consisting of lymphoid aggregates plus multiple large lymphoid nodules, which were most noticeable in the antral mucosa. In addition, one H. pylori-infected cat had a moderate diffuse infiltration of polymorphonuclear leukocytes in the subglandular region of the antrum. H. pylori-like organisms were focally distributed in glandular crypts of the antrum. Two of the H. pylori-infected cats had significant (eightfold) increases over baseline in levels of immunoglobulin G H. pylori serum antibody. The H. pylori isolates from the four experimentally infected cats had restriction fragment length polymorphism patterns specific for the flaA gene that were identical to those of the inoculating strain. H. pylori readily colonizes the cat stomach and produces persistent gastritis.

INTRODUCTION Little is known about the challenges facing the pharmaceutical sector in rural counties in the USA. The aim of this pilot study is to determine the main challenges facing the pharmaceutical sector and suggestions for improving the sector in Buchanan County, a poor and marginalized county in Central Appalachia, Virginia. METHODS This cross-sectional study used the drop-by survey based on the first step of the modified Delphi Interview Technique. A convenience sample of healthcare professionals in Buchanan County were asked to complete a self-administered survey instrument between May and August 2011. RESULTS A total of 16 healthcare professionals including six pharmacists completed the survey. The respondents had worked for an average of 13.4 (SD=10.7) years in the County (range: 1-33 years). The main challenges facing the pharmaceutical sector were drug abuse (n=11), doctor shopping by patients (n=9), early refills (n=7) and drug shortage (n=6). Respondents suggested increased patient education by pharmacists (n=6) and better coordination and communication between pharmacy and doctor (n=6) to improve the pharmaceutical sector in the County. CONCLUSIONS Drug abuse, doctor shopping, early refills and drug shortage are the main challenges facing the pharmaceutical sector in Buchanan County. Concerted efforts are required to solve these problems. More research is required to confirm these findings.

Antiplatelet therapy is used widely with proven benefit for the prevention of further ischemic cardiac complications in patients with known coronary artery disease (CAD) and a history of acute coronary syndrome (ACS). The limitations of conventional antiplatelet therapy with aspirin, clopidogrel, or prasugrel, as well as the fact that rates of recurrent ischemic events still remain high with use of these agents, underscore the need to investigate alternate agents that may further reduce event rates while limiting bleeding risk. The selection of antiplatelet therapy is further influenced by the following: ticagrelor was approved in July 2011 by the United States Food and Drug Administration (FDA), and clopidogrel is slated to become available as a generic productin 2012. We provide an overview of emerging agents for the treatment of CAD and ACS, including the reversible P2Y(12) antagonists ticagrelor, cangrelor, and elinogrel, and a new class of oral protease-activated receptor-1 (PAR-1) inhibitors, vorapaxar and atopaxar.The recently approved P2Y(12) antagonists prasugrel and ticagrelor demonstrate enhanced ability to prevent adverse cardiac outcomes. However, this comes at a cost of a potential increased risk of bleeding. New adverse effects have also emerged, including dyspnea for all of the reversible P2Y(12) antagonists (ticagrelor, cangrelor, and elinogrel) and ventricular pauses for ticagrelor. In addition, the newer P2Y(12) antagonists have a faster onset and offset. Two of these agents, cangrelor and elinogrel, are available as intravenous formulations, which may provide additional benefits in patients who undergo coronary artery bypass graft (CABG) surgery. Trials with the PAR-1 inhibitors have also shown trends toward reductions in cardiac events, but not without the possibility of increased bleeding. More than ever, as the arsenal of antiplatelet therapy expands, health care providers need to understand the pharmacologic and pharmacodynamic differences between conventional and emerging antiplatelet therapies for patients with ACS and CAD. Health care providers must also carefully assess patient-specific factors such as risk of thrombosis, concomitant disease states, age, drug adherence, and aspirin dose, and plan for those patients who will be undergoing CABG when selecting antiplatelet therapy in order to optimally balance bleeding and thrombosis risk.

Medication adherence in heart failure is especially complex due to the nature of the syndrome. Heart failure develops secondary to a wide variety of etiologies and covers a broad spectrum of symptom severity. Heart failure is commonly accompanied by coronary artery disease, hypertension, dyslipidemia, atrial fibrillation, and diabetes mellitus. As a result, patients with heart failure take medications not only for heart failure, but also for a number of other medical conditions. Hence, polypharmacy is common in heart failure patients. Reported medication adherence rates in patients with heart failure have ranged from 2% to 90% reflecting the broad range of types of patients who have heart failure and the differing methods used to assess adherence. A number of barriers to good adherence have been identified in patients with heart failure. Strategies to overcome these barriers have been described, but are often focused on single aspects of improving adherence, which tend to produce relatively small improvements in overall medication adherence. The most productive strategies to improve adherence typically involve multifactorial, multidisciplinary interventions. Disease management programs for heart failure, although not specifically designed to focus only on medication adherence, have been shown to improve adherence to a number of treatments including medications, diet, and exercise. Disease management programs have also been shown to favorably impact the frequency of heart failure hospitalizations and mortality in selected populations of heart failure patients. Efforts continue to define the most appropriate strategies to produce improvements in medication adherence in patients with heart failure.

Thrombosis is an underlying cause of many cardiovascular disorders, and generation of thrombi in the arterial circulation can lead to unstable angina, myocardial infarction, or ischemic stroke. Antithrombotic therapy is widely used, with proven benefit to prevent ischemic stroke and thromboembolic events in patients with atrial fibrillation (AF) or to prevent further ischemic complications in patients with acute coronary syndrome (ACS). Traditional anticoagulants (including unfractionated heparin, low-molecular-weight heparin, and warfarin) and antiplatelet agents (including aspirin, clopidogrel, and prasugrel) are typically used for these indications. Limitations to their use include variable pharmacokinetic and pharmacodynamic profiles, inability to inhibit fibrin-bound thrombin, risk of heparin-induced thrombocytopenia, delayed onset of action, numerous drug interactions, need for substantial laboratory monitoring and dosage titrations, hyporesponsiveness or resistance, hypersensitivity, adverse events, and bleeding. To overcome some of the limitations of traditional agents, new antithrombotic agents under development are highly selective for specific coagulation factors blocking the synthesis of thrombin. Clinicians must have an understanding of the new anticoagulants to aid in the selection of appropriate therapies for patients. We describe the most relevant phases II and III clinical trials that evaluated several recent emerging anticoagulant drugs for use in patients with AF or ACS. The advantages of many new agents include predictable pharmaco-dynamic response and pharmacokinetic parameters, allowing for fixed oral dosing with no need for laboratory monitoring. For patients with AF, dabigatran is already approved for the prevention of stroke and systemic embolism, rivaroxaban appears to be an effective alternative to warfarin in high-risk patients, and apixaban may also be an effective alternative to aspirin in patients unable to take warfarin. Otamixaban shows promise as an intravenous alternative for patients with ACS in the acute care setting. Likewise, rivaroxaban, dabigatran, and darexaban with or without dual antiplatelet therapy may be beneficial for secondary prevention of ischemic events in patients with ACS.

Diabetes mellitus affects approximately 24 million people in America. Analysis of the economic cost of diabetes in the USA are an estimated $174 billion. Type 2 diabetes results from numerous causes and most highly associated causative factors being lifestyle choices. Dietary and exercise practices can increase or decrease one’s chance of developing type 2 diabetes. The cornerstones of preventing and treating type 2 diabetes, lifestyle modification and medication therapy, are aimed at maintaining optimal blood glucose levels. There is clear evidence of benefit that tight glycemic control decreases diabetes related complications and costs. Lifestyle modification is considered first line therapy for treatment and prevention of type 2 diabetes. The progressive nature of diabetes often requires the use of drug therapy to achieve glycemic targets. Tight glycemic control provides a cost effective means of reducing unnecessary health care expenses. Identifying ways to contain health care costs and obtain high value for our health care investments continues to be a priority.

Background. Childhood obesity is becoming a global epidemic which may result in increased morbidity and mortality during young adulthood.Objectives. To identify factors associated with overweight and that of obesity among Kuwaiti elementary male school children aged 6–10 years.Methods. Weights and heights of 662 students at a randomly selected school were collected to obtain body mass index (BMI).Results. The prevalence of overweight and obesity among the students were 20.2% and 16.8%, respectively. There were a variety of factors associated with overweight and obesity; however, having one or more obese brother, an unemployed father, or a high (>11) number of persons living at home was significantly associated with higher risk of overweight and obesity. Increased age and school level as well as having a chronic disease were associated with the risk of overweight.Conclusion. Health education programs for families should be implemented to help control overweight and obesity in Kuwaiti children.

Objective To estimate if Clostridium difficile-associated disease (CDAD) is increasing in peripartum women. Study Design Peripartum CDAD was assessed through 1) passive surveillance collecting clinical and pathology data on severe cases and 2) survey among infectious disease consultants (ICDs) in the Emerging Infections Network. Results Ten severe cases were collected; most had associated antibiotic use. Seven women were either admitted to the ICU or underwent colectomy. Three infants were stillborn, and 3 women died. The epidemic Clostridium difficile strain was found in 2 cases. Among 798 ICDs, 419 (52%) participated in the survey. Thirty-seven respondents (9%) recalled 55 cases, mostly in the postpartum period with 21 complications, mainly due to relapse. Conclusion Severe CDAD may be increasing in peripartum women. Clinicians should have a low threshold for testing, be aware of the potential for severe outcomes, and take steps to reduce both the risk of disease and resultant complications.

Background Harm reduction programs are often vulnerable to political and vocal opposition despite documented evidence of their effectiveness and economic benefit. It is not well understood if opponents to harm reduction represent the general public’s attitudes. Objective To understand the attitudes of the people of British Columbia (BC) towards various harm reduction strategies and services, and factors associated with support for harm reduction. Methods A random-digit dialing telephone survey assessing attitudes towards various harm reduction strategies was administered to British Columbians in August 2011 (n = 2000). We compared the level of support for general harm reduction by sex, age, education level, and area of residence (Health Authority region) (χ2). Multivariate logistic regression was used to assess odds of support for harm reduction. Results Overall support for general harm reduction among participants was 76%; needle distribution 72%; needle distribution in one’s local community 65%; and safer inhalation equipment distribution 52%. In the multivariate analysis, those with significantly lower odds of supporting harm reduction were male, older, had equal or less than high school education or completed a certificate/diploma program, and resided in the Fraser Health Authority region. The Health Authority region with a municipality that has introduced a bylaw prohibiting the implementation of harm reduction services was found to have 69% support for harm reduction. Another Health Authority region with a municipality that closed a long-standing needle distribution site was found to have over 78% support. Conclusion In contrast to some local policies, our results show the British Columbians surveyed in our study support harm reduction. It is unclear whether policy makers are swayed by a vocal minority or block harm reduction activities for other reasons. Tailoring messages towards segments of the public less likely to support harm reduction, as well civic policy-makers and the media, may help to reduce stigma and gain support for harm reduction services designed to protect and improve the health of the individual and the public.

A10 Background Lung cancer is the number one cancer-related cause of death in the world. The poor prognosis for lung cancer patients is largely due to the lack of an effective non-invasive method to detect the disease in its early stage. Using quantitative nuclear morphometry of sputum cells, we have previously demonstrated that in the presence of tumour, cytologically normal appearing diploid cells may exhibit malignancy-associated changes (MACs) and that these changes may be used as surrogate markers for early detection. The molecular basis for MACs is not known. Objective Our objective is to identify malignancy-associated gene expression changes in normal bronchial epithelial cells obtained by bronchial brushing. Methods We compared the pre- and post-surgical resection gene expression profiles of bronchial epithelial cells obtained by brushing of airways in the lung opposite to the one containing the lung cancer. Agilent whole genome expression arrays were used to generate mRNA transcript profiles for seven paired normal bronchial brushings taken before and 3 to 6 months after surgical resection of the tumour. Ingenuity Pathway Analysis software was used to identify downstream expression targets of the soluble signaling factors VEGF, TGF-β, TNF-α, and IL-8, which have been reported to be secreted by lung tumour cells. The target genes identified were analyzed for malignancy induced differential gene expression between normal bronchial epithelial cells from cancerous and non-cancerous environments. Results We detected differential expression of multiple target genes in the bronchial brush cells. Genes that were found to be differentially expressed included downstream targets of the signaling molecules EGF,TGF-β, and VEGF. Conclusion Soluble signaling molecules secreted by lung malignancies induce MACs, as evident by altered gene expression after removal of the tumour. Although further investigation is necessary, our results are consistent with previous observation that lung tumours can induce MACs in normal appearing bronchial cells in the vicinity of the tumor. MACs may be a potential marker for early detection of lung cancer. This data also provides evidence that MACs can be measured quantitatively in bronchial brush cells using gene expression analysis. Citation Information: Cancer Prev Res 2008;1(7 Suppl):A10.

This study attempted to determine the effects of husband and wife intoxication on attributions of blame in a wife abuse incident. Participants read case history or newspaper accounts of a violent incident in which either, both, or neither spouse was intoxicated While the majority of blame was assigned to the husband, apparent drunkenness of the spouses influenced participants' attributions. When the husband was drunk, relatively more blame was assigned to situational factors and less to him. In contrast, when the wife was intoxicated, she received more blame than when she was sober.

Background: The Alere point-of-care (POC) Pima (TM) CD4 analyzer allows for decentralized testing and expansion to testing antiretroviral therapy (ART) eligibility. A consortium conducted a pooled multi-data technical performance analysis of the Pima CD4. Methods: Primary data (11,803 paired observations) comprised 22 independent studies between 2009-2012 from the Caribbean, Asia, Sub-Saharan Africa, USA and Europe, using 6 laboratory-based reference technologies. Data were analyzed as categorical (including binary) and numerical (absolute) observations using a bivariate and/or univariate random effects model when appropriate. Results: At a median reference CD4 of 383 cells/mu l the mean Pima CD4 bias is -23 cells/mu l (average bias across all CD4 ranges is 10 % for venous and 15 % for capillary testing). Sensitivity of the Pima CD4 is 93 % (95 % confidence interval [CI] 91.4 % - 94.9 %) at 350 cells/mu l and 96 % (CI 95.2 % - 96.9 %) at 500 cells/mu l, with no significant difference between venous and capillary testing. Sensitivity reduced to 86 % (CI 82 % - 89 %) at 100 cells/mu l (for Cryptococcal antigen (CrAg) screening), with a significant difference between venous (88 %, CI: 85 % - 91 %) and capillary (79 %, CI: 73 % - 84 %) testing. Total CD4 misclassification is 2.3 % cases at 100 cells/mu l, 11.0 % at 350 cells/mu l and 9.5 % at 500 cells/mu l, due to higher false positive rates which resulted in more patients identified for treatment. This increased by 1.2 %, 2.8 % and 1.8 %, respectively, for capillary testing. There was no difference in Pima CD4 misclassification between the meta-analysis data and a population subset of HIV+ ART naive individuals, nor in misclassification among operator cadres. The Pima CD4 was most similar to Beckman Coulter PanLeucogated CD4, Becton Dickinson FACSCalibur and FACSCount, and less similar to Partec CyFlow reference technologies. Conclusions: The Pima CD4 may be recommended using venous-derived specimens for screening (100 cells/mu l) for reflex CrAg screening and for HIV ART eligibility at 350 cells/mu l and 500 cells/mu l thresholds using both capillary and venous derived specimens. These meta-analysis findings add to the knowledge of acceptance criteria of the Pima CD4 and future POC tests, but implementation and impact will require full costing analysis.