• The cost of data collection for performance monitoring in hospitals: protocol for a systematic review

      Gannon, Brenda; Jones, Cheryl; Wakai, Abel; O’Sullivan, Ronan; Beaumont Hospital, Dublin; National Children’s Research Centre, Dublin;Cork University Hospital (2014-06-16)
      Abstract Background Key performance indicators (KPIs) are used to identify where organisational performance is meeting desired standards and where performance requires improvement. Valid and reliable KPIs depend on the availability of high-quality data, specifically, the relevant minimum data set (MDS; the core data identified as the minimum required to measure performance for a KPI) elements. However, the feasibility of collecting the relevant MDS elements is always a limitation of performance monitoring using KPIs. Preferably, data should be integrated into service delivery, and where additional data are required that are not currently collected as part of routine service delivery, there should be an economic evaluation to determine the cost of data collection. The aim of this systematic review is to synthesise the evidence base concerning the costs of data collection in hospitals for performance monitoring using KPIs, and to identify hospital data collection systems that have proven to be cost minimising. Methods/Design Electronic databases will be systematically searched for publications in English that examine the cost of data collection within a hospital context. The database searches will be supplemented by searching through citations and references. Screening of both titles and abstracts will be done by two independent reviewers. All disagreements will be resolved by an independent third reviewer. Data analysis will be completed and reported in a narrative review. Discussion This review will cohere the evidence base regarding cost-minimising hospital data collections systems for performance monitoring and if these are associated with potential benefits for patients. Systematic review registration PROSPERO CRD42014007450
    • Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: Study protocol for a randomised controlled trial

      Barrett, Michael J; Cronin, John; Murphy, Adrian; McCoy, Siobhan; Hayden, John; an Fhailí, SinéadNic; Grant, Tim; Wakai, Abel; McMahon, Corrina; Walsh, Sean; et al. (2012-05-30)
      Abstract Background Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain. Methods/design This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05. Discussion This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting. Trial registration Current Controlled Trials ISRCTN67469672 and EudraCT no. 2011-005161-20
    • Oral flucloxacillin and phenoxymethylpenicillin versus flucloxacillin alone for the emergency department outpatient treatment of cellulitis: study protocol for a randomised controlled trial

      Quirke, Michael; Wakai, Abel; Gilligan, Peadar; O’Sullivan, Ronan (2013-06-03)
      Abstract Background Oral flucloxacillin, either alone or in combination with phenoxymethylpenicillin, is a commonly prescribed antibiotic for the treatment of cellulitis, particularly in Ireland and the United Kingdom. This study aims to establish the non-inferiority of oral monotherapy (flucloxacillin alone) to dual therapy (flucloxacillin and phenoxymethylpenicillin) for the outpatient treatment of cellulitis in adults. Methods/design This study is a multicentre, randomised, double-blind, placebo-controlled trial of adults who present to the emergency department (ED) with cellulitis that is deemed treatable on an outpatient basis with oral antibiotics. After fulfilling specified inclusion and exclusion criteria, informed consent will be taken. Patients will be given a treatment pack containing 7 days of treatment with flucloxacillin 500 mg four times daily and placebo or flucloxacillin 500 mg four times daily and phenoxymethylpenicillin 500 mg four times daily. The primary outcome measure under study is the proportion of patients in each group in which there is greater than or equal to a 50% reduction in the area of diameter of infection from the area measured at enrolment at the end-of-treatment visit (7 to 10 days). Secondary endpoints include a health-related quality of life measurement as rated by the SF-36 score and the Extremity Soft Tissue Infection Score (not validated), compliance and adverse events. Patients will be followed up by telephone call at 3 days, end-of-treatment visit (EOT) at 7 to 10 days and test-of-cure (TOC) visit at 30 days. To achieve 90% power, a sample size of 172 patients per treatment arm is needed. This assumes a treatment success rate of 85% with oral flucloxacillin and phenoxymethylpenicillin, an equivalence threshold Δ = 12.5% and an α = 0.025. Non-inferiority will be assessed using a one-sided confidence interval on the difference of proportions between the two groups. Standard analysis including per-protocol and intention-to-treat will be performed. Discussion This trial aims to establish the non-inferiority of flucloxacillin monotherapy to dual therapy in the treatment of uncomplicated cellulitis among ED patients. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines. Trial registration EudraCT Number 2008-006151-42
    • The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)

      Boland, Fiona; Quirke, Michael; Gannon, Brenda; Plunkett, Sinead; Hayden, John; McCourt, John; O’Sullivan, Ronan; Eustace, Joseph; Deasy, Conor; Wakai, Abel (2017-08-24)
      Abstract Background Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here. Methods/design Patients will be randomised to either orally administered flucloxacillin 500 mg four times daily and placebo or orally administered 500 mg of flucloxacillin four times daily and phenoxymethylpenicillin 500 mg four times daily. The trial consists of a 7-day intervention period and a 2-week follow-up period. Study measurements will be taken at four specific time points: at patient enrolment, day 2–3 after enrolment and commencing treatment (early clinical response (ECR) visit), day 8–10 after enrolment (end-of-treatment (EOT) visit) and day 14–21 after enrolment (test-of-cure (TOC) visit). The primary outcome measure is investigator-determined clinical response measured at the TOC visit. The secondary outcomes are as follows: lesion size at ECR, clinical treatment failure at each follow-up visit, adherence and persistence of trial patients with orally administered antibiotic therapy at EOT, health-related quality of life (HRQoL) and pharmacoeconomic assessments. The plan for the presentation and comparison of baseline characteristics and outcomes is described in this paper. Discussion This trial aims to establish the non-inferiority of orally administered flucloxacillin monotherapy with orally administered flucloxacillin/phenoxymethylpenicillin dual therapy for the ED-directed outpatient treatment of cellulitis. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines. The SAP for the PEDOCELL trial was developed a priori in order to minimise analysis bias. Trial registration EU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016. ClinicalTrials.gov, ID: NCT02922686 . Registered on 9 August 2016.
    • Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial

      Cronin, John; Kennedy, Una; McCoy, Siobhan; an Fhailí, Sinéad N; Crispino-O’Connell, Gloria; Hayden, John; Wakai, Abel; Walsh, Sean; O’Sullivan, Ronan (2012-08-21)
      Abstract Background Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß2-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to examine whether a single dose of oral dexamethasone (0.3 mg/kg) is clinically non-inferior to prednisolone (1 mg/kg/day for three days) in the treatment of exacerbations of asthma in children who attend the Emergency Department. Methods/design This is a randomized, non-inferiority, open-label clinical trial. After informed consent with or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison between the Pediatric Respiratory Assessment Measure (PRAM) across both groups on Day 4. The PRAM score, a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, will be performed by a clinician blinded to treatment allocation. Secondary outcomes include relapse, hospital admission and requirement for further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to follow-up), we will be able to reject the null hypothesis - that the population means of the experimental and control groups are equal with a probability (power) of 0.9. The Type I error probability associated with this test (of the null hypothesis) is 0.05. Discussion This clinical trial may provide evidence that a shorter steroid course using dexamethasone can be used in the treatment of acute pediatric asthma, thus eliminating the issue of compliance to treatment. Registration ISRCTN26944158 and EudraCT Number 2010-022001-18
    • Structured sedation programs in the emergency department, hospital and other acute settings: protocol for systematic review of effects and events

      McCoy, Siobhán; Wakai, Abel; Blackburn, Carol; Barrett, Michael; Murphy, Adrian; Brenner, Maria; Larkin, Philip; Crispino-O’Connell, Gloria; Ratnapalan, Savithiri; O’Sullivan, Ronan (2013-10-01)
      Abstract Background The use of procedural sedation outside the operating theatre has increased in hospital settings and has gained popularity among non-anesthesiologists. Sedative agents used for procedural pain, although effective, also pose significant risks to the patient if used incorrectly. There is currently no universally accepted program of education for practitioners using or introducing procedural sedation into their practice. There is emerging literature identifying structured procedural sedation programs (PSPs) as a method of ensuring a standardized level of competency among staff and reducing risks to the patient. We hypothesize that programs of education for healthcare professionals using procedural sedation outside the operating theatre are beneficial in improving patient care, safety, practitioner competence and reducing adverse event rates. Methods/Design Electronic databases will be systematically searched for studies (randomized and non-randomized) examining the effectiveness of structured PSPs from 1966 to present. Database searches will be supplemented by contact with experts, reference and citation checking, and a grey literature search. No language restriction will be imposed. Screening of titles and abstracts, and data extraction will be performed by two independent reviewers. All disagreements will be resolved by discussion with an independent third party. Data analysis will be completed adhering to procedures outlined in the Cochrane Handbook of Systematic Reviews of Interventions. If the data allows, a meta-analysis will be performed. Discussion This review will cohere evidence on the effectiveness of structured PSPs on sedation events and patient outcomes within the hospital and other acute care settings. In addition, it will examine key components identified within a PSP associated with patient safety and improved patient outcomes. Trial registration PROSPERO registration number: CRD42013003851
    • Study protocol for evaluating the implementation and effectiveness of an emergency department longitudinal patient monitoring system using a mixed-methods approach

      Ward, Marie; McAuliffe, Eilish; Wakai, Abel; Geary, Una; Browne, John; Deasy, Conor; Schull, Michael; Boland, Fiona; McDaid, Fiona; Coughlan, Eoin; et al. (2017-01-23)
      Abstract Background Early detection of patient deterioration is a key element of patient safety as it allows timely clinical intervention and potential rescue, thus reducing the risks of serious patient safety incidents. Longitudinal patient monitoring systems have been widely recommended for use to detect clinical deterioration. However, there is conflicting evidence on whether they improve patient outcomes. This may in part be related to variation in the rigour with which they are implemented and evaluated. This study aims to evaluate the implementation and effectiveness of a longitudinal patient monitoring system designed for adult patients in the unique environment of the Emergency Department (ED). Methods A novel participatory action research (PAR) approach is taken where socio-technical systems (STS) theory and analysis informs the implementation through the improvement methodology of ‘Plan Do Study Act’ (PDSA) cycles. We hypothesise that conducting an STS analysis of the ED before beginning the PDSA cycles will provide for a much richer understanding of the current situation and possible challenges to implementing the ED-specific longitudinal patient monitoring system. This methodology will enable both a process and an outcome evaluation of implementing the ED-specific longitudinal patient monitoring system. Process evaluations can help distinguish between interventions that have inherent faults and those that are badly executed. Discussion Over 1.2 million patients attend EDs annually in Ireland; the successful implementation of an ED-specific longitudinal patient monitoring system has the potential to affect the care of a significant number of such patients. To the best of our knowledge, this is the first study combining PAR, STS and multiple PDSA cycles to evaluate the implementation of an ED-specific longitudinal patient monitoring system and to determine (through process and outcome evaluation) whether this system can significantly improve patient outcomes by early detection and appropriate intervention for patients at risk of clinical deterioration.