An analysis of complaints about hospital care in the Republic of Ireland.

BACKGROUND: Patients and family members make complaints about their hospital care in order to express their dissatisfaction with the care received and prompt quality improvement. Increasingly, it is being understood that these complaints could serve as important data on how to improve care if analysed using a standardized tool. The use of the Healthcare Complaints Analysis Tool (HCAT) for this purpose has emerged internationally for quality and safety improvement. Previous work has identified hot spots (areas in care where harm occurs frequently) and blind spots (areas in care that are difficult for staff members to observe) from complaints analysis. This study aimed to (i) apply the HCAT to a sample of complaints about hospital care in the Republic of Ireland (RoI) to identify hot spots and blind spots in care and (ii) compare the findings of this analysis to a previously published study on hospital complaints in the UK. METHODS: A sample of complaints was taken from 16 hospitals in the RoI in Quarter 4 of 2019 (n = 641). These complaints were coded using the HCAT to classify complaints by domain, category, severity, stage of care and harm. Chi-squared tests were used to identify hot spots, and logistic regression was used to identify blind spots. The findings of this study were compared to a previously published UK study that used HCAT to identify hot spots and blind spots. RESULTS: Hot spots were identified in Irish hospital complaints while patients were receiving care on the ward, during initial examination and diagnosis, and while they were undergoing operations or procedures. This aligned with hot spots identified in the UK study. Blind spots were found for systemic problems, where patients experience multiple issues across their care. CONCLUSIONS: Hot spots and blind spots for patient harm can be identified in hospital care using the HCAT analysis. These in turn could be used to inform improvement interventions, and direct stakeholders to areas that require urgent attention. This study also highlights the promise of the HCAT for use across different healthcare systems, with similar results emerging from the RoI and the UK.

Doctors' attitudes to, beliefs about, and experiences of the regulation of professional competence: a scoping review protocol.

BACKGROUND: Historically, individual doctors were responsible for maintaining their own professional competence. More recently, changing patient expectations, debate about the appropriateness of professional self-regulation, and high-profile cases of malpractice have led to a move towards formal regulation of professional competence (RPC). Such programmes require doctors to demonstrate that they are fit to practice, through a variety of means. Participation in RPC is now part of many doctors' professional lives, yet it remains a highly contested area. Cost, limited evidence of impact, and lack of relevance to practice are amongst the criticisms cited. Doctors' attitudes towards RPC, their beliefs about its objectives and effectiveness, and their experiences of trying to meet its requirements can impact engagement with the process. We aim to conduct a scoping review to map the empirical literature in this area, to summarise the key findings, and to identify gaps for future research. METHODS: We will conduct our review following the six phases outlined by Arksey and O'Malley, and Levac. We will search seven electronic databases: Academic Search Complete, Business Source Complete, CINAHL, PsycINFO, PubMed, Social Sciences Full Text, and SocINDEX for relevant publications, and the websites of medical regulatory and educational organisations for documents. We will undertake backward and forward citation tracking of selected studies and will consult with international experts regarding key publications. Two researchers will independently screen papers for inclusion and extract data using a piloted data extraction tool. Data will be collated to provide a descriptive summary of the literature. A thematic analysis of the key findings will be presented as a narrative summary of the literature. DISCUSSION: We believe that this review will be of value to those tasked with the design and implementation of RPC programmes, helping them to maximise doctors' commitment and engagement, and to researchers, pointing to areas that would benefit from further enquiry. This research is timely; internationally existing programmes are evolving, new programmes are being initiated, and many jurisdictions do not yet have programmes in place. There is an opportunity for learning across different programmes and from the experiences of established programmes. Our review will support that learning. SYSTEMATIC REVIEW REGISTRATION: PROSPERO does not register scoping reviews.

Medication related litigation in Ireland: A 6-year review.

AIMS: The primary aims of the study were to identify those medications most frequently associated with clinical litigation in Ireland and to quantify the cost of such litigation. Secondary aims were to identify where in the medication-use process claims were most likely to arise, the medication incident types involved and the primary injury alleged. METHODS: The National Incident Management System (NIMS) for incident and claims management was searched to identify all medication-related claims finalised from 2011 to 2016 (inclusive). The physical case files were obtained and additional data not available on NIMS was extracted in order to build a detailed picture of the incident and subsequent claim. RESULTS: The search identified 79 relevant claims, of which 48 closed with a payment to the plaintiff. These 48 claims involved 54 medications. Medication groups identified included general anaesthetics (n = 7), opioids (n = 6), penicillins, antithrombotics and local anaesthetics (all n = 5). The errors alleged occurred exclusively at the administration (58%) and prescribing (42%) stages of the medication-use process. Medication incident types included wrong dose/strength (n = 17), wrong drug (n = 7) and adverse drug reaction (n = 6). The most commonly pleaded primary injuries were allergic reaction (n = 9), deterioration in clinical status (n = 9) and post-traumatic stress disorder (n = 8). The median total cost of these claims was €60 991, including median damages of €33 858. CONCLUSIONS: This study links data on medication incidents, actual harm to patients and litigation costs. Thus, it presents a comprehensive picture of the consequences of medication error.

A Socio-Technical Exploration for Reducing & Mitigating the Risk of Retained Foreign Objects.

A Retained Foreign Object (RFO) is a fairly infrequent but serious adverse event. An accurate rate of RFOs is difficult to establish due to underreporting but it has been estimated that incidences range between 1/1000 and 1/19,000 procedures. The cost of a RFO incident may be substantial and three-fold: (i) the cost to the patient of physical and/or psychological harm; (ii) the reputational cost to an institution and/or healthcare provider; and (iii) the financial cost to the taxpayer in the event of a legal claim. This Health Research Board-funded project aims to analyse and understand the problem of RFOs in surgical and maternity settings in Ireland and develop hospital-specific foreign object management processes and implementation roadmaps. This project will deploy an integrated evidence-based assessment methodology for social-technical modelling (Supply, Context, Organising, Process & Effects/ SCOPE Analysis Cube) and bow tie methodologies that focuses on managing the risks in effectively implementing and sustaining change. It comprises a multi-phase research approach that involves active and ongoing collaboration with clinical and other healthcare staff through each phase of the research. The specific objective of this paper is to present the methodological approach and outline the potential to produce generalisable results which could be applied to other health-related issues.

A national stakeholder consensus study of challenges and priorities for clinical learning environments in postgraduate medical education.

BACKGROUND: High quality clinical learning environments (CLE) are critical to postgraduate medical education (PGME). The understaffed and overcrowded environments in which many residents work present a significant challenge to learning. The purpose of this study was to develop a national expert group consensus amongst stakeholders in PGME to; (i) identify important barriers and facilitators of learning in CLEs and (ii) indicate priority areas for improvement. Our objective was to provide information to focus efforts to provide high quality CLEs. METHODS: Group Concept Mapping (GCM) is an integrated mixed methods approach to generating expert group consensus. A multi-disciplinary group of experts were invited to participate in the GCM process via an online platform. Multi-dimensional scaling and hierarchical cluster analysis were used to analyse participant inputs in regard to barriers, facilitators and priorities. RESULTS: Participants identified facilitators and barriers in ten domains within clinical learning environments. Domains rated most important were those which related to residents' connection to and engagement with more senior doctors. Organisation and conditions of work and Time to learn with senior doctors during patient care were rated as the most difficult areas in which to make improvements. CONCLUSIONS: High quality PGME requires that residents engage and connect with senior doctors during patient care, and that they are valued and supported both as learners and service providers. Academic medicine and health service managers must work together to protect these elements of CLEs, which not only shape learning, but impact quality of care and patient safety.

Protocol for a realist review of workplace learning in postgraduate medical education and training.

BACKGROUND: Postgraduate medical education and training (PGMET) is a complex social process which happens predominantly during the delivery of patient care. The clinical learning environment (CLE), the context for PGMET, shapes the development of the doctors who learn and work within it, ultimately impacting the quality and safety of patient care. Clinical workplaces are complex, dynamic systems in which learning emerges from non-linear interactions within a network of related factors and activities. Those tasked with the design and delivery of postgraduate medical education and training need to understand the relationship between the processes of medical workplace learning and these contextual elements in order to optimise conditions for learning. We propose to conduct a realist synthesis of the literature to address the overarching questions; how, why and in what circumstances do doctors learn in clinical environments? This review is part of a funded projected with the overall aim of producing guidelines and recommendations for the design of high quality clinical learning environments for postgraduate medical education and training. METHODS: We have chosen realist synthesis as a methodology because of its suitability for researching complexity and producing answers useful to policymakers and practitioners. This realist synthesis will follow the steps and procedures outlined by Wong et al. in the RAMESES Publication Standards for Realist Synthesis and the Realist Synthesis RAMESES Training Materials. The core research team is a multi-disciplinary group of researchers, clinicians and health professions educators. The wider research group includes experts in organisational behaviour and human resources management as well as the key stakeholders; doctors in training, patient representatives and providers of PGMET. DISCUSSION: This study will draw from the published literature and programme, and substantive, theories of workplace learning, to describe context, mechanism and outcome configurations for PGMET. This information will be useful to policymakers and practitioners in PGMET, who will be able to apply our findings within their own contexts. Improving the quality of clinical learning environments can improve the performance, humanism and wellbeing of learners and improve the quality and safety of patient care. SYSTEMATIC REVIEW REGISTRATION: The review is not registered with the PROSPERO International Prospective Register of Systematic Reviews as the review objectives relate solely to education outcomes.

Viral Bronchiolitis is Associated With Altered Cytokine Gene Expression and Lymphocyte Activation Status.

BACKGROUND: Disease severity in viral bronchiolitis is often difficult to predict at onset, and may be related to the host immune response. Recognizing the particular immunologic features of infants who develop severe disease might offer an opportunity for developing diagnostic tools to facilitate early intervention and improve outcomes. METHODS: We compared cytokine gene expression (by real-time reverse-transcriptase polymerase chain reaction), cytokine concentrations (by enzyme-linked immunosorbent assay) and the activation status of lymphocytes (by flow cytometry) in the peripheral blood of children hospitalized with moderate and severe viral bronchiolitis and a group of age-matched controls. RESULTS: Analysis was undertaken on 57 children with viral bronchiolitis and 33 controls. Interleukin-7 mRNA expression at enrollment in peripheral blood mononuclear cells differed significantly between those with moderate and severe bronchiolitis, and correlated with both the subsequent length of hospital stay and need for supplemental oxygen therapy. Serum interleukin-10 concentration also distinguished moderate from severe disease. Participants with viral bronchiolitis demonstrated a more activated γδ-T cell phenotype (Vδ1+), but a more naive TCR αß-T cell compartment compared with controls. CONCLUSIONS: Viral bronchiolitis is characterized by a distinct pattern of cytokine expression and lymphocyte activation. These changes suggest an inadequate innate response in severe disease, and may offer potential as markers of disease severity.

Interleukin-15 is associated with disease severity in viral bronchiolitis.

Disease severity in viral bronchiolitis in infancy is difficult to predict and has been linked to host innate immunity. The study aimed to investigate the innate cytokine interleukin-15 (IL-15) as a marker of disease severity.A prospective single-centre observational study was conducted in a university-affiliated paediatric teaching hospital, comparing children (0-18 months) hospitalised for viral bronchiolitis, those admitted to the paediatric intensive care unit with severe disease and healthy age-matched controls. IL-15-related parameters were compared between groups. PCR and microRNA (miRNA) sequencing was undertaken on natural killer (NK) cells collected from study participants.Samples from 88 children with viral bronchiolitis and 43 controls enrolled between 2009 and 2012 were analysed. Peripheral blood mononuclear cell (PBMC) IL-15 mRNA expression was significantly higher in those with moderate severity bronchiolitis compared with controls and those with severe disease. Serum IL-15 levels correlated with disease severity. The relative frequency of NK cells in peripheral blood was significantly reduced in participants with bronchiolitis. The NK cell miRNA transcriptome in bronchiolitis was distinct. Targets of de-regulated miRNA were differentially expressed in bronchiolitis, including JAK3, STAT5A and NFKB1 on the IL-15 signalling pathway.IL-15 is associated with disease severity in children hospitalised with viral bronchiolitis.

The Role of Short-Chain Fatty Acids, Produced by Anaerobic Bacteria, in the Cystic Fibrosis Airway.

RATIONALE: Anaerobic bacteria are present in large numbers in the airways of people with cystic fibrosis (PWCF). In the gut, anaerobes produce short-chain fatty acids (SCFAs) that modulate immune and inflammatory processes. OBJECTIVES: To investigate the capacity of anaerobes to contribute to cystic fibrosis (CF) airway pathogenesis via SCFAs. METHODS: Samples of 109 PWCF were processed using anaerobic microbiological culture with bacteria present identified by 16S RNA sequencing. SCFA levels in anaerobic supernatants and bronchoalveolar lavage (BAL) were determined by gas chromatography. The mRNA and/or protein expression of two SCFA receptors, GPR41 and GPR43, in CF and non-CF bronchial brushings and 16HBE14o(-) and CFBE41o(-) cells were evaluated using reverse transcription polymerase chain reaction, Western blot analysis, laser scanning cytometry, and confocal microscopy. SCFA-induced IL-8 secretion was monitored by ELISA. MEASUREMENTS AND MAIN RESULTS: Fifty-seven (52.3%) of 109 PWCF were anaerobe positive. Prevalence increased with age, from 33.3% to 57.7% in PWCF younger (n = 24) and older (n = 85) than 6 years of age. All evaluated anaerobes produced millimolar concentrations of SCFAs, including acetic, propionic, and butyric acids. SCFA levels were higher in BAL samples of adults than in those of children. GPR41 levels were elevated in CFBE41o(-) versus 16HBE14o(-) cells; CF versus non-CF bronchial brushings; and 16HBE14o(-) cells after treatment with cystic fibrosis transmembrane conductance regulator inhibitor CFTR(inh)-172, CF BAL, or inducers of endoplasmic reticulum stress. SCFAs induced a dose-dependent and pertussis toxin-sensitive IL-8 response in bronchial epithelial cells, with a higher production of IL-8 in CFBE41o(-) than in 16HBE14o(-) cells. CONCLUSIONS: This study illustrates that SCFAs contribute to excessive production of IL-8 in CF airways colonized with anaerobes via up-regulated GPR41.

Unexpected genetic heterogeneity for primary ciliary dyskinesia in the Irish Traveller population.

We present a study of five children from three unrelated Irish Traveller families presenting with primary ciliary dyskinesia (PCD). As previously characterized disorders in the Irish Traveller population are caused by common homozygous mutations, we hypothesised that all three PCD families shared the same recessive mutation. However, exome sequencing showed that there was no pathogenic homozygous mutation common to all families. This finding was supported by histology, which showed that each family has a different type of ciliary defect; transposition defect (family A), nude epithelium (family B) and absence of inner and outer dynein arms (family C). Therefore, each family was analysed independently using homozygosity mapping and exome sequencing. The affected siblings in family A share a novel 1 bp duplication in RSPH4A (NM_001161664.1:c.166dup; p.Arg56Profs*11), a radial-spoke head protein involved in ciliary movement. In family B, we identified three candidate genes (CCNO, KCNN3 and CDKN1C), with a 5-bp duplication in CCNO (NM_021147.3:c.258_262dup; p.Gln88Argfs*8) being the most likely cause of ciliary aplasia. This is the first study to implicate CCNO, a DNA repair gene reported to be involved in multiciliogenesis, in PCD. In family C, we identified a ∼3.5-kb deletion in DYX1C1, a neuronal migration gene previously associated with PCD. This is the first report of a disorder in the relatively small Irish Traveller population to be caused by >1 disease gene. Our study identified at least three different PCD genes in the Irish Traveller population, highlighting that one cannot always assume genetic homogeneity, even in small consanguineous populations.

Outcome in patients with cystic fibrosis liver disease.

BACKGROUND: Liver disease is an important complication in CF. AIMS: To determine if CFLD is a risk factor for mortality in CF, and which baseline characteristics predict all-cause mortality. METHODS: Irish children with CFLD, and their age and gender matched controls were enrolled at baseline and reviewed after 10years to determine which characteristics predict mortality. RESULTS: 72/84 (85.71%) participants were followed, (mean age Cases 21.71yrs SD 6.5, CF controls 23.62 SD 5.6, 22 (61%) males), with no difference in duration of follow-up. Nineteen participants (26.4%) died, 38.9% (14/36) with CFLD and 13.89% (5/36) CF controls (Odds Ratio (OR) 3.94 95% CI:1.23-12.56 p=0.005). In logistic regression, liver disease (OR 4.28 95% CI 1.07-17.16) female gender (OR 12.25 95% CI 2.37-63.24), reduced pulmonary function, (OR 5.11 95% CI 1.09-23.81) were each independent risk factors for mortality in CF. CONCLUSIONS: Liver disease is an independent risk factor for mortality in CF.

Successful treatment of idiopathic pulmonary capillaritis with intravenous cyclophosphamide.

Idiopathic pulmonary hemosiderosis (IPH), a subtype of diffuse alveolar hemorrhage is a rare condition, first described by Virchow in 1864. Historically, it manifests in children in the first decade of life with the combination of hemoptysis, iron deficiency anemia, and alveolar infiltrates on chest radiograph. More recently, diffuse alveolar hemorrhage has been classified by the absence or presence of pulmonary capillaritis (PC), the latter carrying a potential for a poorer outcome. While systemic corticosteroids remain the first line treatment option, other immune modulators have been trailed including hydroxychloroquine, azathioprine, 6-mercaptopurine, and cyclophosphamide with varying results. Our case demonstrates for the first time, the successful use of intravenous cyclophosphamide in the management of chronic idiopathic PC.

Cystic fibrosis genotype and assessing rates of decline in pulmonary status.

PURPOSE: To evaluate the hierarchical phenotypic expression of cystic fibrosis transmembrane conductance regulator (CFTR) genotypes in the respiratory system as has been documented in the pancreas. MATERIALS AND METHODS: This study was institutional review board approved; informed consent was not required. HIPAA guidelines were followed. Genotype effects were assessed by using chest radiographic and pulmonary function test (PFT) results in 93 patients. Serial chest radiographic and PFT (percentage of predicted forced expiratory volume in 1 second [FEV(1)], percentage of predicted forced vital capacity [FVC]) results were compared by using analysis of variance with repeated measures. By using CFTR class of mutations, two groups were created: group S (severe disease) and group M (mild disease). Within group S, three subgroups were created: A consisted of patients with two class I alleles; B, class I allele and class II or III allele; C, class II allele and class II or III allele. Group M consisted of patients with at least one allele from class IV-VI. RESULTS: Within group S, subgroup A had a faster deterioration than B or C according to radiographic data (A vs B, P = .014; A vs C, P = .009), with only a borderline difference in FEV(1) for subgroups A versus C (P = .031). Otherwise, PFTs were not sensitive for distinguishing subgroups. Only radiographic results identified that subgroup B had faster progression than C (P = .003); all parameters had trends of decline in the same direction. Group S had a faster decline than group M (radiography, P = .005; FVC, P = .011; FEV(1), P = .529). CONCLUSION: Disease progressed more rapidly with gene class hierarchical correlations seen in pancreatic disease. Radiography was more sensitive for identifying differences.

Validation of continuous glucose monitoring in children and adolescents with cystic fibrosis: a prospective cohort study.

OBJECTIVE: To validate continuous glucose monitoring (CGM) in children and adolescents with cystic fibrosis. RESEARCH DESIGN AND METHODS: Paired oral glucose tolerance tests (OGTTs) and CGM monitoring was undertaken in 102 children and adolescents with cystic fibrosis (age 9.5-19.0 years) at baseline (CGM1) and after 12 months (CGM2). CGM validity was assessed by reliability, reproducibility, and repeatability. RESULTS: CGM was reliable with a Bland-Altman agreement between CGM and OGTT of 0.81 mmol/l (95% CI for bias +/- 2.90 mmol/l) and good correlation between the two (r = 0.74-0.9; P < 0.01). CGM was reproducible with no significant differences in the coefficient of variation of the CGM assessment between visits and repeatable with a mean difference between CGM1 and CGM2 of 0.09 mmol/l (95% CI for difference +/- 0.46 mmol/l) and a discriminant ratio of 13.0 and 15.1, respectively. CONCLUSIONS: In this cohort of children and adolescents with cystic fibrosis, CGM performed on two occasions over a 12-month period was reliable, reproducible, and repeatable.

Chest radiographs for outcome assessment in cystic fibrosis.

We compare a chest radiographic scoring system developed by our group to spirometry in quantifying the longitudinal progression of lung disease among cystic fibrosis (CF) patients, and we evaluate the use of this radiographic scoring system in identifying the treatment effect of an inhaled antibiotic. Results suggest that longitudinally acquired chest radiographs, when scored using our scoring system, are at least as sensitive as lung function in detecting the progression of lung disease in CF patients.

Churg-Strauss syndrome in children: a clinical and pathologic review.

Churg-Strauss syndrome is a vasculitis accompanied by asthma and eosinophilia. It is generally considered a disease of adults; occurrence in children has been reported infrequently. Here we report 2 pediatric patients with Churg-Strauss syndrome manifesting with prominent pulmonary involvement. One, a 16-year-old with a previous history of asthma, presented with pleuritic chest pain and a peripheral pulmonary nodule complicated by an eosinophilic pleural effusion. The other patient presented at age 6 with cough, weight loss, and radiographic infiltrates. Lung biopsies revealed elements characteristic of Churg-Strauss syndrome, including eosinophilic microabscesses and vasculitis. Three- and 5-year follow-up showed continued symptoms in both patients despite medical therapy. Both patients illustrate many of the typical features of Churg-Strauss syndrome. We report these cases to expand the scant knowledge about Churg-Strauss syndrome in pediatric patients and to heighten awareness that this serious disease may affect the pediatric population. The relevant literature on Churg-Strauss syndrome, with specific reference to childhood cases, is reviewed.

CF: an X-ray database to assess effect of aerosolized tobramycin.

This paper assesses the effectiveness of aerosolized tobramycin (TOBI) on cystic fibrosis (CF) lung disease, using a radiologic tool. The published tool, the age-based severity curve (ABS), is derived from Brasfield scoring of chest X-rays (CXR). This study evaluates both the usefulness of the ABS as an assessment tool and the effectiveness of TOBI. Thirty-eight patients were treated with TOBI. Twenty-four treated with dornase alfa were excluded. Fourteen patients, aged 2 months to 22 years (mean, 17 months of TOBI treatment), comprised the study group. Radiographs were obtained over a mean of 7.8 years (SD = 6.5 years; range, 9 months-18 years). Two hundred and eighty-two CXR of TOBI patients were analyzed following the ABS protocol. Rate of decline in radiologic status of the TOBI group and ABS were compared. Also, TOBI was assessed by comparing rate of decline before and after initiation of treatment. The TOBI group's radiologic assessment was compared to its rate of decline in pulmonary function studies and published population data. Rate of decline in ABS was 0.175 Brasfield points/year vs. 0.150 points/year in the TOBI group (P < 0.001). Before treatment, the TOBI group's rate of decline was 0.169 Brasfield points/year; after treatment, it was 0.150 points/year (P = 0.02). Forced vital capacity revealed a statistically significant slowing in rate of decline on TOBI. Although not statistically significant, rate of decline in forced expiratory volume at 1 sec showed a similar trend. The degree of slowing in decline is similar to that previously reported for pulmonary function studies.

C5L2, a nonsignaling C5A binding protein.

C5a anaphylatoxin, a potent inflammatory mediator, is known to act through a specific G protein coupled receptor. However, some of the complex effects of C5a in vivo may not be explained solely by the deletion of the known receptor. Here, we show that an orphan receptor, identified as C5L2, is a high affinity C5a binding protein. Unlike the previously described C5aR, C5L2 is obligately uncoupled from heterotrimeric G proteins, in part by virtue of an amino acid alteration in the so-called DRY sequence at the end of the third transmembrane segment. Both human and murine C5L2 bear a leucine for arginine replacement at this site. C5L2, when transfected into several cell types, is weakly phosphorylated in transfected cells following binding of C5a but does not induce significant activation of MAP kinases, mediate calcium flux, or stimulate chemotaxis. Bone marrow cells from wild type respond robustly to C5a with induction and suppression of a number of inflammation related genes. In contrast, C5a receptor deficient mice, which bear C5L2 alone, do not respond to C5a with changes in gene transcription by microarray analyses. Biophysical properties of the C5L2, including slow ligand on and off rates, absence of internalization, and relatively high affinity for the C5a des Arg metabolite, suggest that this receptor may serve to modulate C5a biological functions in vivo. Finally, in contrast to previous reports, we find absolutely no interaction of C5L2 with other anaphylatoxins C3a and C4a.