Implementation of Novel Quality Assurance Program for Hepatitis C Viral Load Point of Care Testing.

All patients should have access to accurate and timely test results. The introduction of point of care testing (PoCT) for infectious diseases has facilitated access to those unable to access traditional laboratory-based medical testing, including those living in remote and regional locations, or individuals who are marginalized or incarcerated individuals. In many countries, laboratory testing for infectious diseases, such as hepatitis C virus (HCV), is performed in a highly regulated environment. However, this is not the case for PoCT, where testing is performed by non-laboratory staff and quality controls are often lacking. An assessment of the provision of laboratory-based quality assurance to PoCT for infectious disease was conducted and the barriers to participation identified. A novel approach to providing quality assurance to PoCT sites, in particular those testing for HCV, was designed and piloted. This novel approach incudes identifying and validating sample types that are inactivated and stable at ambient temperature, creating cost-effective supply chains to facilitate logistics of samples, and the development of a smart phone-enabled portal for data entry and analyses. The creation and validation of this approach to quality assurance of PoCT removes the barriers to participation and acts to improve the quality and accuracy of testing, reduce errors and waste, and improve patient outcomes.

The Paediatric AirWay Suction (PAWS) appropriateness guide for endotracheal suction interventions.

BACKGROUND/OBJECTIVE: Endotracheal suction is an invasive and potentially harmful technique used for airway clearance in mechanically ventilated children. Choice of suction intervention remains a complex and variable process. We sought to develop appropriate use criteria for endotracheal suction interventions used in paediatric populations. METHODS: The RAND Corporation and University of California, Los Angeles Appropriateness Method was used to develop the Paediatric AirWay Suction appropriateness guide. This included defining key terms, synthesising current evidence, engaging an expert multidisciplinary panel, case scenario development, and two rounds of appropriateness ratings (weighing harm with benefit). Indications (clinical scenarios) were developed from common applications or anticipated use, current practice guidelines, clinical trial results, and expert consultation. RESULTS: Overall, 148 (19%) scenarios were rated as appropriate (benefit outweighs harm), 542 (67%) as uncertain, and 94 (11%) as inappropriate (harm outweighs benefit). Disagreement occurred in 24 (3%) clinical scenarios, namely presuction and postsuction bagging across populations and age groups. In general, the use of closed suction was rated as appropriate, particularly in the subspecialty population 'patients with highly infectious respiratory disease'. Routine application of 0.9% saline for nonrespiratory indications was more likely to be inappropriate/uncertain than appropriate. Panellists preferred clinically indicated suction versus routine suction in most circumstances. CONCLUSION: Appropriate use criteria for endotracheal suction in the paediatric intensive care have the potential to impact clinical decision-making, reduce practice variability, and improve patient outcomes. Furthermore, recognition of uncertain clinical scenarios facilitates identification of areas that would benefit from future research.

Validation of Dried Tube Sample Format Quality Controls for the Monitoring of Viral Load and Blood Screening Assays.

HIV viral load (VL) and donor screening assays experience variation and require quaity assurance (QA). NRL sought to confirm a dried tube sample format (HIVDTS) sample type for use in quality control (QC) programs for HIV molecular testing. 50 µL of HIV supernatant at 1 × 105 copies per millilitre (copies/mL)) was dried for 48 hours at room temperature. Post-production and shipped integrity studies were undertaken. Dried HIVDTS was reconstituted in PBS buffer and tested in HIV VL (six participants) or blood screening assays (four participants). Results were entered into NRL's QC monitoring software (EDCNet™) for analysis. The mean of 224 VL results when HIVDTS QCs were tested in Biocentric HIV GENERIC Charge Virale assay was 4.54 log10 copies/mL, with the percentage coefficient of variation (CV%) ranging from 1.75 to 13.20%. The mean Ct value for HIVDTS QCs tested on Roche Cobas MPX assay results was 28.71 (range 28.33 to 29.14), with CV% ranging from 1.56 to 3.98%. The study confirms HIVDTS QCs can effectively monitor the performance of HIV molecular testing and offers a cheaper alternative to commercial QC samples that require cold-chain shipping on dry ice and UN3373 conditions.

Reliability and criterion-related validity testing (construct) of the Endotracheal Suction Assessment Tool (ESAT©).

AIMS AND OBJECTIVES: To establish criterion-related construct validity and test-retest reliability for the Endotracheal Suction Assessment Tool© (ESAT©). BACKGROUND: Endotracheal tube suction performed in children can significantly affect clinical stability. Previously identified clinical indicators for endotracheal tube suction were used as criteria when designing the ESAT©. Content validity was reported previously. The final stages of psychometric testing are presented. DESIGN: Observational testing was used to measure construct validity and determine whether the ESAT© could guide "inexperienced" paediatric intensive care nurses' decision-making regarding endotracheal tube suction. Test-retest reliability of the ESAT© was performed at two time points. METHODS: The researchers and paediatric intensive care nurse "experts" developed 10 hypothetical clinical scenarios with predetermined endotracheal tube suction outcomes. "Experienced" (n = 12) and "inexperienced" (n = 14) paediatric intensive care nurses were presented with the scenarios and the ESAT© guiding decision-making about whether to perform endotracheal tube suction for each scenario. Outcomes were compared with those predetermined by the "experts" (n = 9). Test-retest reliability of the ESAT© was measured at two consecutive time points (4 weeks apart) with "experienced" and "inexperienced" paediatric intensive care nurses using the same scenarios and tool to guide decision-making. RESULTS: No differences were observed between endotracheal tube suction decisions made by "experts" (n = 9), "inexperienced" (n = 14) and "experienced" (n = 12) nurses confirming the tool's construct validity. No differences were observed between groups for endotracheal tube suction decisions at T1 and T2. CONCLUSION: Criterion-related construct validity and test-retest reliability of the ESAT© were demonstrated. Further testing is recommended to confirm reliability in the clinical setting with the "inexperienced" nurse to guide decision-making related to endotracheal tube suction. RELEVANCE TO CLINICAL PRACTICE: The ESAT© is the first validated tool to systematically guide endotracheal nursing practice for the "inexperienced" nurse.

Content validity testing of the ESAT©: A decision aid tool for performing endotracheal suction in children.

BACKGROUND AND PURPOSE: Endotracheal tube suction performed in children can affect clinical stability. Previous research has identified clinical indicators used to perform endotracheal suction. These were used to develop the Endotracheal Suction Assessment Tool© (ESAT©). This study sought to evaluate the degree to which the ESAT© items as a whole constitute an operational definition of the construct used to determine whether a paediatric intensive care nurse should perform the endotracheal tube suction procedure. METHODS: Lynn's process for calculation of content validity and scale content validity index using a team of expert reviewers was adopted. Experts were drawn from paediatric intensive care units in Australia (n=6), United Kingdom (n=1), Switzerland (n=1) and Canada (n=1). These experts established the content validity index of the Endotracheal Suction Assessment Tool© using a minimum preset a-priori criterion agreement of 0.78 and a scale content validity index of 0.8. Scale content validity index was used to enhance the interpretability of the content validity data. RESULTS: All 15 items achieved the preset a-priori agreement for apparent internal consistency. Minor adjustments were required to improve the clarity of four items. The content validity index ranged from 0.8 to 1.0 and scale content validity index ranged from 0.9 to 1.0 for all items. CONCLUSION: Item and scale content validity indexes of the tool were established. Further psychometric testing for construct validity and stability over time is required to establish clinical utility of the tool and practice of novice paediatric intensive care nurses and other PIC health professionals.

Audit of Endotracheal Tube Suction in a Pediatric Intensive Care Unit.

We report outcomes of a clinical audit examining criteria used in clinical practice to rationalize endotracheal tube (ETT) suction, and the extent these matched criteria in the Endotracheal Suction Assessment Tool(ESAT)©. A retrospective audit of patient notes ( N = 292) and analyses of criteria documented by pediatric intensive care nurses to rationalize ETT suction were undertaken. The median number of documented respiratory and ventilation status criteria per ETT suction event that matched the ESAT© criteria was 2 [Interquartile Range (IQR) 1-6]. All criteria listed within the ESAT© were documented within the reviewed notes. A direct link was established between criteria used for current clinical practice of ETT suction and the ESAT©. The ESAT©, therefore, reflects documented clinical decision making and could be used as both a clinical and educational guide for inexperienced pediatric critical care nurses. Modification to the ESAT

Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up.

BACKGROUND: Adenotonsillectomy is a common pediatric surgical procedure. Our knowledge of the recovery profile, parental understanding, and expectations is limited. We aimed to assess the incidence of pain, nausea, and vomiting in children undergoing adenotonsillectomy on postoperative day 3 and 7. We also wished to evaluate parental understanding regarding discharge instructions as well as parental expectations and experience of their child's recovery. METHODS: We enrolled 100 children (0-16 years) undergoing elective adenotonsillectomy. On day 3 and 7, parents were questioned about their child's level of pain, nausea/vomiting and their understanding regarding postoperative instructions. RESULTS: Hundred children (median, 6.68 years) were recruited. 52% of parents rated their child's pain as VAS ≥ 5 on day 3, dropping to 30% by day 7. Almost 33% of patients experienced nausea on day 3, dropping to 11.6% by day 7. A similar trend was observed for postoperative vomiting. Most parents, 89%, agreed that postoperative instructions were clear. However, knowledge regarding when to seek emergency medical advice was found to be lacking. On day 7, only 44% of parents reported that their child's recovery met their expectations. CONCLUSION: Adenotonsillectomy is associated with significant pain and PONV, persisting into the seventh postoperative day. Parental education and information seems inadequate and needs to be improved.

The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial.

CONTEXT: There is ongoing debate regarding the optimal timing for tracheal extubation in children at increased risk of perioperative respiratory adverse events, particularly following adenotonsillectomy. OBJECTIVE: To assess the occurrence of perioperative respiratory adverse events in children undergoing elective adenotonsillectomy extubated under deep anaesthesia or when fully awake. DESIGN: Prospective, randomised controlled trial. SETTING: Tertiary paediatric hospital. PATIENTS: One hundred children (<16 years), with at least one risk factor for perioperative respiratory adverse events (current or recent upper respiratory tract infection in the past 2 weeks, eczema, wheezing in the past 12 months, dry nocturnal cough, wheezing on exercise, family history of asthma, eczema or hay fever as well as passive smoking). INTERVENTION: Deep or awake extubation. MAIN OUTCOME MEASURE: The occurrence of perioperative respiratory adverse events (laryngospasm, bronchospasm, persistent coughing, airway obstruction, desaturation <95%). RESULTS: There were no differences between the two groups with regard to age, medical and surgical parameters. The overall incidence of complications did not differ between the two groups; tracheal extubation in fully awake children was associated with a greater incidence of persistent coughing (60 vs. 35%, P = 0.028), whereas the incidence of airway obstruction relieved by simple airway manoeuvres in children extubated while deeply anaesthetised was greater (26 vs. 8%, P = 0.03). There was no difference in the incidence of oxygen desaturation lasting more than 10 s. CONCLUSION: There was no difference in the overall incidence of perioperative respiratory adverse events. Both extubation techniques may be used in high-risk children undergoing adenotonsillectomy provided that the child is monitored closely in the postoperative period. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12609000387224.

Does take-home analgesia improve postoperative pain after elective day case surgery? A comparison of hospital vs parent-supplied analgesia.

BACKGROUND: More children are undergoing same-day surgery. While advances have been made in pediatric pain management, there have been few studies addressing pain management in the home (Br J Anaesth, 82, 1999 and 319). We wished to investigate whether issuing parents with take-home analgesia would improve postoperative pain scores and/or parental satisfaction following hospital discharge. METHODS: Two hundred children, and their parents, attending for day case surgery at our institution were randomized into two groups. One group received advice regarding the management of postoperative pain and were given a pack containing discharge medications: group 'dispensed'. The other group received the same advice, but did not receive any medication: group 'advised'. Telephone interviews were conducted to assess pain scores, PONV, functional activity, analgesia requirements, and satisfaction rates. RESULTS: Data were available for 181 patients (median age, 4 years; range, 0-12 years): 89 children in group 'dispensed' and 92 children in group 'advised'. Postoperative instructions were followed by 86% in group 'advised' and 89% in group 'dispensed' (P = 0.68). Although all parents received analgesia advice, only 85/181 (48%) recalled the information. Rates for no/mild pain and moderate/severe pain were similar between the two groups: 59% (group 'advised') vs 62% (group 'dispensed') and 41% (group 'advised') vs 38% (group 'dispensed') (P = 0.78). DISCUSSION: Our study did not show any differences in the incidence of pain/parental satisfaction between the two groups. Analgesia advice given to parents was poorly retained, suggesting that other methods for disseminating information should be considered.

The difficult airway trolley in pediatric anesthesia: an international survey of experience and training.

BACKGROUND: The pediatric difficult airway can be unexpected, leading to significant morbidity and mortality. Standardized emergency airway equipment should be available on a regularly checked difficult airway trolley (DAT). We conducted a survey to investigate pediatric anesthetists' knowledge, experience, and confidence with the DAT. METHODS: Members of the Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI), European Society for Paediatric Anaesthesiology (ESPA) and their national societies, Canadian Pediatric Anesthesia Society (CPAS), and Society for Paediatric Anaesthesia in New Zealand and Australia (SPANZA) were invited to complete a survey between January and April 2011. RESULTS: Six hundred and ninety-three anesthetists replied to the questionnaire. Six hundred and thirty-three (92%) stated they have a DAT in their theater suite, with 587 (98%) knowing its location. Three hundred and eight-seven (56%) anesthetists received formal DAT training. The lowest training levels were observed in Australia and the UK; 42% and 59%, respectively. Those receiving training were more likely to be confident/very confident in knowing the DAT contents (r = -0.321, P = 0.01). Three hundred and fifty-five (59%) anesthetists had used the DAT in the last 6 months, 82 (14%) in the last 6-12 months, 91 (15%) >1 year ago, and 72 (12%) had never used it. Frequency of use correlated moderately with higher confidence levels (r = -0.398, P = 0.01). One hundred and eight-three (31%) reported having experienced problems with DAT equipment (missing 20%, faulty 4%, unfamiliarity 7%). DISCUSSION: Training and recent use of the DAT increases anesthetists' confidence, but is not a universal practice. A significant number of anesthetists reported problems with the DAT, raising issues of equipment maintenance and quality control.

Development of a population pharmacokinetic model for parecoxib and its active metabolite valdecoxib after parenteral parecoxib administration in children.

BACKGROUND: Parecoxib is a cyclooxygenase-2 selective inhibitor used in management of postoperative pain in adults. This study aimed to provide pediatric pharmacokinetic information for parecoxib and its active metabolite valdecoxib. METHODS: Thirty-eight children undergoing surgery received parecoxib (1 mg/kg IV to a maximum of 40 mg) at induction of anesthesia, and plasma samples were collected for drug measurement. Population pharmacokinetic parameters were estimated using nonlinear mixed effects modeling. Area under the valdecoxib concentration-time curve and time above cyclooxygenase-2 in vitro 50% inhibitory concentration for free valdecoxib were simulated. RESULTS: A three-compartment model best represented parecoxib disposition, whereas one compartment was adequate for valdecoxib. Age was linearly correlated with parecoxib clearance (5.0% increase/yr). There was a sigmoid relationship between age and both valdecoxib clearance and distribution volume. Time to 50% maturation was 87 weeks postmenstrual age for both. In simulations using allometric-based doses the 90% prediction interval of valdecoxib concentration-time curve in children 2-12.7 yr included the mean for adults given 40 mg parecoxib IV. Simulated free valdecoxib plasma concentration remained above the in vitro 50% inhibitory concentrations for more than 12 h. In children younger than 2 yr, a dose reduction is likely required due to ongoing metabolic maturation. CONCLUSIONS: The final pharmacokinetic model gave a robust representation of parecoxib and valdecoxib disposition. Area under the valdecoxib concentration-time curve was similar to that in adults (40 mg), and simulated free valdecoxib concentration was above the cyclooxygenase-2 in vitro 50% inhibitory concentration for free valdecoxib for at least 12 h.

Determining standard criteria for endotracheal suctioning in the paediatric intensive care patient: an exploratory study.

This four-phase mixed method study developed an evidence based "Endotracheal Suction Assessment Tool" (ESAT) as a guide for nurses undertaking "endotracheal tube" (ETT) suction within "Paediatric Intensive Care" (PIC). Phase 1 involved a comprehensive literature review to determine the most commonly used criteria for assessing the need for ETT suction. In Phase 2 an "Endotracheal Suction Questionnaire" (ESQ) was developed to survey experienced PIC nurses in Australia and New Zealand regarding their ETT suction decision making process and validity testing of the ESQ. In Phase 3, the ESQ was administered to target group (n=104). In Phase 4, the empirical evidence generated from this study, based upon the criteria rated by nurses in this study as being most clinically important and essential during the decision making process, determined the ESAT design. Analyses of quantitative results showed a positive correlation between the perceived frequency of use of a criterion and the appropriateness of the assessment. Where a criterion was used less frequently as a clinical indicator for the requirement for ETT suction, participants had a lower regard for this when rating the criterion as a specific single indicator to perform suction. Findings from qualitative data identified six criteria not previously documented within the literature. Further testing and validation of the tool within the PIC setting will determine the clinical viability of the ESAT.