Developing a process to measure actual harm from medication errors in paediatric inpatients: From design to implementation.

AIMS: The potential harm associated with medication errors is widely reported, but data on actual harm are limited. When actual harm has been measured, assessment processes are often poorly described, limiting their ability to be reproduced by other studies. Our aim was to design and implement a new process to assess actual harm resulting from medication errors in paediatric inpatient care. METHODS: Prescribing errors were identified through retrospective medical record reviews (n = 26 369 orders) and medication administration errors through direct observation (n = 5137 administrations) in a tertiary paediatric hospital. All errors were assigned potential harm severity ratings on a 5-point scale. Multidisciplinary panels reviewed case studies for patients assigned the highest three potential severity ratings and determined the following: actual harm occurrence and severity level, plausibility of a link between the error(s) and identified harm(s) and a confidence rating if no harm had occurred. RESULTS: Multidisciplinary harm panels (n = 28) reviewed 566 case studies (173 prescribing related and 393 administration related) and found evidence of actual harm in 89 (prescribing = 22, administration = 67). Eight cases of serious harm cases were found (prescribing = 1, administration = 7) and no cases of severe harm. The panels were very confident in 65% of cases (n = 302) where no harm was found. Potential and actual harm ratings varied. CONCLUSIONS: This harm assessment process provides a systematic method for determining actual harm from medication errors. The multidisciplinary nature of the panels was critical in evaluating specific clinical, therapeutic and contextual considerations including care delivery pathways, therapeutic dose ranges and drug-drug and drug-disease interactions.

Short- and long-term effects of an electronic medication management system on paediatric prescribing errors.

Electronic medication management (eMM) systems are designed to improve safety, but there is little evidence of their effectiveness in paediatrics. This study assesses the short-term (first 70 days of eMM use) and long-term (one-year) effectiveness of an eMM system to reduce prescribing errors, and their potential and actual harm. We use a stepped-wedge cluster randomised controlled trial (SWCRCT) at a paediatric referral hospital, with eight clusters randomised for eMM implementation. We assess long-term effects from an additional random sample of medication orders one-year post-eMM. In the SWCRCT, errors that are potential adverse drug events (ADEs) are assessed for actual harm. The study comprises 35,260 medication orders for 4821 patients. Results show no significant change in overall prescribing error rates in the first 70 days of eMM use (incident rate ratio [IRR] 1.05 [95%CI 0.92-1.21], but a 62% increase (IRR 1.62 [95%CI 1.28-2.04]) in potential ADEs suggesting immediate risks to safety. One-year post-eMM, errors decline by 36% (IRR 0.64 [95%CI 0.56-0.72]) and high-risk medication errors decrease by 33% (IRR 0.67 [95%CI 0.51-0.88]) compared to pre-eMM. In all periods, dose error rates are more than double that of other error types. Few errors are associated with actual harm, but 71% [95%CI 50-86%] of patients with harm experienced a dose error. In the short-term, eMM implementation shows no improvement in error rates, and an increase in some errors. A year after eMM error rates significantly decline suggesting long-term benefits. eMM optimisation should focus on reducing dose errors due to their high frequency and capacity to cause harm.

Rights of children and young people in health care.

The 30th anniversary of the United Nations Convention on the Rights of the Child has provided opportunities for reflection, critical analysis and renewed commitment. While the convention is comprehensive and far reaching, the focus here is specifically on the rights of children in health care, with particular emphasis on the Australian setting. Surveys and related studies have highlighted persistent gaps and inadequacies in these domains of practice and especially in the direct and meaningful engagement of children and young people. The implementation of article 12 of the convention, the right of children to be heard and taken seriously, has been identified as a distinctly confronting challenge and the subject of improvement initiatives across, as well as beyond, health services. Appropriate reforms can only be progressed and sustained within a broader policy context that places children first and foremost, values their participatory engagement and embraces the crucial contribution of children's health and wellbeing to the future of our society.

Clinical indicators for common paediatric conditions: Processes, provenance and products of the CareTrack Kids study.

BACKGROUND: In order to determine the extent to which care delivered to children is appropriate (in line with evidence-based care and/or clinical practice guidelines (CPGs)) in Australia, we developed a set of clinical indicators for 21 common paediatric medical conditions for use across a range of primary, secondary and tertiary healthcare practice facilities. METHODS: Clinical indicators were extracted from recommendations found through systematic searches of national and international guidelines, and formatted with explicit criteria for inclusion, exclusion, time frame and setting. Experts reviewed the indicators using a multi-round modified Delphi process and collaborative online wiki to develop consensus on what constituted appropriate care. RESULTS: From 121 clinical practice guidelines, 1098 recommendations were used to draft 451 proposed appropriateness indicators. In total, 61 experts (n = 24 internal reviewers, n = 37 external reviewers) reviewed these indicators over 40 weeks. A final set of 234 indicators resulted, from which 597 indicator items were derived suitable for medical record audit. Most indicator items were geared towards capturing information about under-use in healthcare (n = 551, 92%) across emergency department (n = 457, 77%), hospital (n = 450, 75%) and general practice (n = 434, 73%) healthcare facilities, and based on consensus level recommendations (n = 451, 76%). The main reason for rejecting indicators was 'feasibility' (likely to be able to be used for determining compliance with 'appropriate care' from medical record audit). CONCLUSION: A set of indicators was developed for the appropriateness of care for 21 paediatric conditions. We describe the processes (methods), provenance (origins and evolution of indicators) and products (indicator characteristics) of creating clinical indicators within the context of Australian healthcare settings. Developing consensus on clinical appropriateness indicators using a Delphi approach and collaborative online wiki has methodological utility. The final indicator set can be used by clinicians and organisations to measure and reflect on their own practice.

Quality of Health Care for Children in Australia, 2012-2013.

Importance: The quality of routine care for children is rarely assessed, and then usually in single settings or for single clinical conditions. Objective: To estimate the quality of health care for children in Australia in inpatient and ambulatory health care settings. Design, Setting, and Participants: Multistage stratified sample with medical record review to assess adherence with quality indicators extracted from clinical practice guidelines for 17 common, high-burden clinical conditions (noncommunicable [n = 5], mental health [n = 4], acute infection [n = 7], and injury [n = 1]), such as asthma, attention-deficit/hyperactivity disorder, tonsillitis, and head injury. For these 17 conditions, 479 quality indicators were identified, with the number varying by condition, ranging from 9 for eczema to 54 for head injury. Four hundred medical records were targeted for sampling for each of 15 conditions while 267 records were targeted for anxiety and 133 for depression. Within each selected medical record, all visits for the 17 targeted conditions were identified, and separate quality assessments made for each. Care was evaluated for 6689 children 15 years of age and younger who had 15 240 visits to emergency departments, for inpatient admissions, or to pediatricians and general practitioners in selected urban and rural locations in 3 Australian states. These visits generated 160 202 quality indicator assessments. Exposures: Quality indicators were identified through a systematic search of local and international guidelines. Individual indicators were extracted from guidelines and assessed using a 2-stage Delphi process. Main Outcomes and Measures: Quality of care for each clinical condition and overall. Results: Of 6689 children with surveyed medical records, 53.6% were aged 0 to 4 years and 55.5% were male. Adherence to quality of care indicators was estimated at 59.8% (95% CI, 57.5%-62.0%; n = 160 202) across the 17 conditions, ranging from a high of 88.8% (95% CI, 83.0%-93.1%; n = 2638) for autism to a low of 43.5% (95% CI, 36.8%-50.4%; n = 2354) for tonsillitis. The mean adherence by condition category was estimated as 60.5% (95% CI, 57.2%-63.8%; n = 41 265) for noncommunicable conditions (range, 52.8%-75.8%); 82.4% (95% CI, 79.0%-85.5%; n = 14 622) for mental health conditions (range, 71.5%-88.8%); 56.3% (95% CI, 53.2%-59.4%; n = 94 037) for acute infections (range, 43.5%-69.8%); and 78.3% (95% CI, 75.1%-81.2%; n = 10 278) for injury. Conclusions and Relevance: Among a sample of children receiving care in Australia in 2012-2013, the overall prevalence of adherence to quality of care indicators for important conditions was not high. For many of these conditions, the quality of care may be inadequate.

CareTrack Kids-part 2. Assessing the appropriateness of the healthcare delivered to Australian children: study protocol for a retrospective medical record review.

INTRODUCTION: Australian and international clinical practice guidelines are available for common paediatric conditions. Yet there is evidence that there are substantial variations between the guidelines, recommendations (appropriate care) and the care delivered. This paper describes a study protocol to determine the appropriateness of the healthcare delivered to Australian children for 16 common paediatric conditions in acute and primary healthcare settings. METHODS AND ANALYSIS: A random sample of 6000-8000 medical records representing a cross-section of the Australian paediatric population will be reviewed for appropriateness of care against a set of indicators within three Australian states (New South Wales, Queensland and South Australia) using multistage, stratified sampling. Medical records of children aged <16 years who presented with at least one of the study conditions during 2012 and 2013 will be reviewed. ETHICS AND DISSEMINATION: Human Research Ethics Committee approvals have been received from the Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service and Women's and Children's Hospital Network (South Australia). An application is under review for the Royal Australian College of General Practitioners. The authors will submit the results of the study to relevant journals and offer oral presentations to researchers, clinicians and policymakers at national and international conferences.

CareTrack Kids-part 1. Assessing the appropriateness of healthcare delivered to Australian children: study protocol for clinical indicator development.

INTRODUCTION: Despite the widespread availability of clinical guidelines, considerable gaps remain between the care that is recommended (appropriate care) and the care provided. This protocol describes a research methodology to develop clinical indicators for appropriate care for common paediatric conditions. METHODS AND ANALYSIS: We will identify conditions amenable to population-level appropriateness of care research and develop clinical indicators for each condition. Candidate conditions have been identified from published research; burden of disease, prevalence and frequency of presentation data; and quality of care priority lists. Clinical indicators will be developed through searches of national and international guidelines, and formatted with explicit criteria for inclusion, exclusion, time frame and setting. Experts will review the indicators using a wiki-based approach and modified Delphi process. A formative evaluation of the wiki process will be undertaken. ETHICS AND DISSEMINATION: Human Research Ethics Committee approvals have been received from Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service, and the Women's and Children's Health Network (South Australia). Applications are under review with Macquarie University and the Royal Australian College of General Practitioners. We will submit the results of the study to relevant journals and offer national and international presentations.

CareTrack Kids-part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review.

INTRODUCTION: A high-quality health system should deliver care that is free from harm. Few large-scale studies of adverse events have been undertaken in children's healthcare internationally, and none in Australia. The aim of this study is to measure the frequency and types of adverse events encountered in Australian paediatric care in a range of healthcare settings. METHODS AND ANALYSIS: A form of retrospective medical record review, the Institute of Healthcare Improvement's Global Trigger Tool, will be modified to collect data. Records of children aged <16 years managed during 2012 and 2013 will be reviewed. We aim to review 6000-8000 records from a sample of healthcare practices (hospitals, general practices and specialists). ETHICS AND DISSEMINATION: Human Research Ethics Committee approvals have been received from the Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service, and the Women's and Children's Hospital Network in South Australia. An application is under review with the Royal Australian College of General Practitioners. The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers.

Treatment of children with poor risk solid tumors by further escalation of the VETOPEC regimen including very high-dose cyclophosphamide and peripheral stem cell support: an Australian and New Zealand Children's Hematology and Oncology Group study.

BACKGROUND: Children with solid tumors deemed to be poor risk at diagnosis and those who fail to respond or recur after chemotherapy have adverse outcomes. We sought to increase the dosage of cyclophosphamide (CPA) in the VETOPEC regimen (vincristine, etoposide, and CPA) with a view to improving the response rate and survival. PROCEDURE: Patients underwent peripheral blood stem cell (PBSC) harvest after standard dose VETOPEC (CPA 40 mg/kg/day for 3 days) followed by filgrastim. Those with sufficient PBSC received up to four intensive cycles (ICs) of VETOPEC with CPA dosages of 60-90 mg/kg/day for 3 days (escalated by 5 mg/kg/day in cohorts of at least five patients) followed by PBSC and filgrastim. RESULTS: Of the 59 enrolled patients, 58 were treated with mobilization chemotherapy and 57 proceeded to PBSC harvest. From 1 to 4 VETOPEC ICs were administered to 51 patients. The maximum tolerated dosage of CPA was not reached. The best response rate during the ICs for patients with recurrent or refractory/progressive disease was 67%; overall survival was 28% at 5 years and 25% at 10 years. The response rate for patients with newly diagnosed high-risk tumors was 89%. CONCLUSIONS: The VETOPEC regimen with CPA dosages up to 90 mg/kg/day for 3 days followed by PBSC and filgrastim can be given in a timely manner with manageable toxicity. Outcomes were not improved when compared to prior VETOPEC studies. VETOPEC produces high response rates and warrants further evaluation in appropriate patients with newly diagnosed high-risk solid tumors.

Responding to cultural diversity at two Sydney-based children's hospitals.

AIM: To study and document the challenges of culturally and linguistically diverse (CALD) families in tertiary paediatric settings. METHODS: Mixed methods, both qualitative and quantitative, were used at Sydney Children's Hospital, Randwick and the Children's Hospital at Westmead, during 2006-2007. A telephone survey of 46 questions was implemented on 269 occasions in one of nine languages. In depth qualitative studies of seven families of various migration, settlement and health experiences were undertaken over a four month period, involving a total of 25 interviews in one of four languages. Members of the respective clinical teams were also engaged in 25 formal interviews and four focus groups. A further 25 combined meetings between the clinical teams and respective families were observed and documented. In addition, 16 senior managers were also interviewed. RESULTS: Accessing hospital records for the study revealed that relevant demographic data were often incomplete. Quantitative analyses of the telephone survey demonstrated statistically significant differences between the CALD and Anglo-Australian cohorts in: access to appropriate information (language specific, accessible, non-technical and appropriately documented); as well as effective communication (with doctors, nurses, admission or clerical staff and other health staff). Comparisons contradicted assumptions of overuse of hospital resources by CALD clients. Interpreter services were moderately utilised but widely supplemented by informal and suboptimal channels. Qualitative exploration supported and further explained the findings. CONCLUSIONS: The findings of this research have demonstrated important differences, as well as gaps and shortcomings, in service provision for CALD families that lend themselves to both further study and to interventions aimed at continuing improvement.

Introducing clinical paediatrics to medical students: a novel hospital visitation programme involving Kindergarten children.

BACKGROUND: Increasing numbers of medical students in Australia and shorter paediatric hospitalisations require new and creative ways to teach clinical paediatric medicine. At the University of New South Wales, Sydney, we developed a programme involving well Kindergarten children visiting Sydney Children's Hospital to introduce medical students to clinical paediatric medicine. AIM: The aim was to teach medical students how to engage children and gain their cooperation while performing paediatric examinations. METHODS: Eight sessions were conducted involving 240 Kindergarten students from seven local primary schools and 217 medical students. School children were escorted by medical students through five activities comprising examination of gross motor skills, testing visual acuity and otoscopy, measuring growth parameters, chest auscultation, pulse counting and blood pressure cuff inflation. Questionnaires were used to gather quantitative and qualitative evaluation data. RESULTS: The programme achieved its main objective, with 94% of students rating highly their learning about interacting with children and appreciating the challenges in examining them. Medical students (94%), tutors (100%) and participating schools (100%) thought the programme should be continued. CONCLUSION: This new, innovative programme involving well children introduces medical students to clinical paediatric medicine.

Multiple accountabilities in incident reporting and management.

In this article, we examine the current and increasing emphasis on accountability and patient safety in health care, focusing on practices of incident reporting and management in New South Wales, Australia. We describe the frames of accountability associated with an incident reporting system, and explore how this system manifests in practice. In contrast to literature that situates incident reporting and local practices as oppositional, we used ethnographic methods to observe the incident management practices of clinical staff in a hospital, and found evidence to characterize this relationship differently. We found that accountability has multiple conceptualizations, and we present three findings that demonstrate how the reporting system and incident management policy are interwoven with local enactments of accountability. We suggest that systematic efforts toward improvement cannot be divorced from the local context, and emphasize the importance of local ecologies of practice in facilitating the meaningful utilization of such incident reporting systems.

Handover--Enabling Learning in Communication for Safety (HELiCS): a report on achievements at two hospital sites.

Clinical handover is an area of critical concern, because deficiencies in handover pose a patient safety risk. Redesign of handover must allow for input from frontline staff to ensure that designs fit into existing practices and settings. The HELiCS (Handover--Enabling Learning in Communication for Safety) tool uses a "video-reflexive" technique: handover encounters are videotaped and played back to the practitioners involved for analysis and discussion. Using the video-reflexive process, staff of an emergency department and an intensive care unit at two different tertiary hospitals redesigned their handover processes. The HELiCS study gave staff greater insight into previously unrecognised clinical and operational problems, enhanced coordination and efficiency of care, and strengthened junior-senior communication and teaching. Our study showed that reflexive and "bottom-up" handover redesign can produce outcomes that harbour local fit, practitioner ownership and (to date) sustainability.

Multiagent chemotherapy studied in a xenograft model of medulloblastoma/primitive neuroectodermal tumour: analysis of the VETOPEC regimen.

Brain tumours remain the most important challenge in the treatment of childhood cancer. The intraocular (io) xenograft model was used to study components and variations of the VETOPEC multiagent chemotherapy regimen in the medulloblastoma/primitive neuroectodermal tumour (MB/PNET) xenograft cell line JRMB-6. VETOPEC, a combination of vincristine (VCR), etoposide (VP-16) and escalated dose cyclophosphamide (CPA), has been shown to be highly active in clinical trials. A total of 190 xenografted tumours were treated with one of nine regimens: saline; single agent CPA, VP-16 (single dose [sd], five dosages daily [dx5] or continuous infusion, [ci]) or VCR; combinations of CPA (dx5)+VP-16 (dx5 or ci) or CPA (dx5)+VP-16 (ci)+VCR (sd). Results were calculated using both response (volume reduction >50%) and 'time to progression' (TtP). Effectiveness of CPA was confirmed. Single-agent VCR or VP-16 produced no response. No difference was documented in TtP with VCR, VP-16 (sd) or VP-16 (dx5) versus control, but a significant prolongation occurred when VP-16 was given by ci (p=0.001). With the 3-agent combination of CPA+VP-16 (ci)+VCR a significantly prolonged TtP was documented versus both single agent CPA (p=0.003) and the combination of CPA+VP-16 (dx5) (p=0.004). The results suggest improved efficacy of VP-16 when given as ci in both single-agent and combination settings. The addition of VP-16 (ci)+VCR to an already effective dosage of CPA further prolongs TtP. These data support and progress VETOPEC phase II clinical studies and suggest potential further benefits of prolonged exposure to VP-16 by ci.

Long-term survival following a phase I/II trial with VETOPEC for solid tumors in childhood.

The objective of this study was to evaluate long-term survival after treatment during a phase I/II trial with a specific regimen of vincristine, etoposide, and escalating cyclophosphamide (VETOPEC). Fifty-six children with poor-prognosis solid tumors were enrolled on study between May 1991 and May 1994. All had tumors that had relapsed on, or were refractory to, conventional treatment, or for whom existing treatment options were considered ineffective. The records of all surviving patients were reviewed to ascertain their disease and health status. Of the 56 patients, 10 patients (18%) remain alive with no further disease progression at a median follow-up of 11 years (range 7-13 years). Eight patients (14%) remain completely free of disease. None of the patients show long-term side effects directly attributable to the VETOPEC regimen, apart from one patient with ovarian failure. The VETOPEC regimen can offer not only good tumor responses but also the chance of cure for a surprisingly large number of children with very-poor-prognosis solid tumors. This regimen warrants continuing development and consideration for use in future trials.

Efficacy of vincristine and etoposide with escalating cyclophosphamide in poor-prognosis pediatric brain tumors.

The objective of this study was to assess the efficacy of the VETOPEC regimen, a regimen of vincristine and etoposide with escalating doses of cyclophosphamide (CPA), in pediatric patients with high-risk brain tumors. Three consecutive studies by the Australia and New Zealand Children's Cancer Study Group--VETOPEC I, Baby Brain 91, and VETOPEC II--have used a specific chemotherapy regimen of vincristine (VCR), etoposide (VP-16) and escalating CPA in patients with relapsed, refractory, or high-risk solid tumors. Patients in the VETOPEC II cohort were treated with very high dose CPA with peripheral blood stem cell (PBSC) rescue. We analyzed the subset of patients with high-risk brain tumors treated with these intensive VETOPEC-based protocols to assess the response, toxicity, and survival. We also assessed whether the use of very high dose chemotherapy with stem cell rescue improved the response rate or affected toxicity. Seventy-one brain tumor patients were treated with VETOPEC-based protocols. Of the 54 patients evaluable for tumor response, 17 had a complete response (CR) and 20 a partial response (PR) to treatment, which yielded an overall response rate of 69%. The CR + PR was 83% (19/23) for medulloblastomas, 56% (5/9) for primitive neuroectodermal tumors, 55% (6/11) for grade 3 and 4 astrocytomas, and 80% (6/8) for ependymomas. At a median follow-up of 36 months, overall survival for the entire cohort of 71 patients was 32%, with event-free survival of 13%. There were no toxic deaths within the PBSC-supported VETOPEC II cohort, despite higher CPA doses, compared with 7% among the non-PBSC patients. This regimen produces high response rates in a variety of very poor prognosis pediatric brain tumors. The maximum tolerated dose of CPA was not reached. Higher escalation in doses of CPA did not deliver a further improvement in response. With PBSC rescue in the VETOPEC II study, hematologic toxicity was no longer a limiting factor. The response rates observed support further development of this chemotherapy regimen.

Emergent modes of work and communities of practice.

This paper argues that the recent emphasis on teams in the health services research literature tends to be attributed to our rising recognition that flexible and self-organizing teams are in the best position to handle the increasing complexity and fragmentation of health services. With a brief review of two papers on health-care teams as its point of departure, this paper argues that the concern with teams harbours a realization that the organizational-managerial point of gravity of most clinical work lies with those who do the work. In the context of health reforms sweeping across most countries in the industrialized world, this means that teams are to embody dynamic self-organization as do 'communities of practice (CoPs)', and be the origin of the managerial and documentary realities that describe, define and validate them. Following through on this last point, the paper reflects on some of the constitutive facets of teams as CoPs, and proposes that in the context of health reform such emergent teamness encompass participating, knowledging and boundary spanning. Fusing contextual, attributional and processual dimensions of team conduct, these notions are elaborated to show how descriptions of teamness can be rendered sensitive to the prerogatives of health reform. The paper concludes with outlining some of the implications of this proposal for how we reconceptualize health services management.

Osteochondroma after total body irradiation: an age-related complication.

BACKGROUND: The discovery of a mass lesion in a long-term cancer survivor causes significant anxiety. The causes of such a mass include benign osteochondroma, which has been reported following focal irradiation and total body irradiation (TBI). PROCEDURE: To establish the incidence of osteochondromas following TBI, the medical records of all children treated at the Sydney Children's Hospital who received TBI as part of the conditioning prior to bone-marrow transplantation between 1978 and 1997 were reviewed. RESULTS: Five of 58 children who received TBI as part of the conditioning therapy for bone-marrow transplantation and who have been followed for at least 30 months post-irradiation, developed osteochondromas. All five of the patients had been under 5 years of age when they received TBI (mean 2.4 years), giving an incidence of osteochondroma of 24% in those who received TBI in the first 5 years of life. No osteochondromas have been diagnosed among the 37 patients who were aged between 5 years and 15 years at the time of receiving TBI. The mean latent time to diagnosis of osteochondroma was 4.6 years (range 2.5-9 years). Two patients developed multiple osteochondromas. Two patients required resection of their osteochondromas because of symptoms. Neither showed malignant degeneration. CONCLUSIONS: Younger patients are at increased risk of osteochondroma following TBI. Review of the available literature suggests a low malignant potential of radiation-induced osteochondromas. Knowledge about the behaviour of post-irradiation osteochondromas will help clinicians manage patients appropriately.