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BACKGROUND: Pancreatic and oesophagogastric (OG) cancers have a dismal prognosis and high symptom burden, with supportive care forming an integral component of the care provided to patients. This study aimed to explore the supportive care experiences of patients and caregivers living with pancreatic and OG cancers in order to identify perceived opportunities for improvement. METHODS: Semi-structured individual interviews were conducted with people living with pancreatic and OG cancers, and their caregivers, across Victoria, Australia during 2020. Interviews were thematically analysed to identify common themes. RESULTS: Forty-one participants were interviewed, including 30 patients and 11 caregivers. Three overarching themes, each with multiple sub-themes, were identified: (i) inadequate support for symptoms and issues across the cancer journey (ii) caregiver's desire for greater support, and (iii) a multidisciplinary care team is the hallmark of a positive supportive care experience. Generally, those who had access to a cancer care coordinator and/or a palliative care team recounted more positive supportive care experiences. CONCLUSION: Unmet needs are prevalent across the pancreatic and OG cancer journey, with supportive care provided to varying levels of satisfaction. Greater awareness of and access to high-quality multidisciplinary support services is greatly desired by both patients with pancreatic and OG cancer and their caregivers.
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Neoplasias , Apoyo Social , Cuidadores , Humanos , Neoplasias/diagnóstico , Cuidados Paliativos , Investigación Cualitativa , Victoria/epidemiologíaRESUMEN
BACKGROUND: Clinical quality registries (CQRs) monitor compliance against optimal practice and provide feedback to the clinical community and wider stakeholder groups. Despite a number of CQRs having incorporated the patient perspective to support the evaluation of healthcare delivery, no recommendations for inclusion of patient-reported outcome measures (PROMs) in CQRs exist. The aim of this study was to develop a core set of recommendations for PROMs inclusion of in CQRs. METHOD: An online two-round Delphi survey was performed among CQR data custodians, quality of life researchers, biostatisticians and clinicians largely recruited in Australia. A list of statements for the recommendations was identified from a literature and survey of the Australian registries conducted in 2019. The statements were grouped into the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback and reporting. Eighteen experts were invited to participate, 11 agreed to undertake the first online survey (round 1). Of these, nine experts completed the online survey for round 2. RESULTS: From 117 statements presented to the Delphi panel in round 1, a total of 72 recommendations (55 from round 1 and 17 from round 2) with median importance (MI) ≥ 7 and disagreement index (DI) < 1 were proposed for inclusion into the final draft set and were reviewed by the project team. Recommendations were refined for clarity and to read as stand-alone statements. Ten overlapped conceptually and, therefore, were merged to reduce repetition. The final 62 recommendations were sent for review to the panel members for their feedback, which was incorporated into the final set. CONCLUSION: This is the first study to develop preliminary recommendations for PROMs inclusion in CQRs. Recommendations for PROMs implementation are critically important for registries to assure meaningful PROMs data capture, use, interpretation, and reporting to improve health outcomes and healthcare value.
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Medición de Resultados Informados por el Paciente , Calidad de Vida , Australia , Técnica Delphi , Humanos , Sistema de Registros , Encuestas y CuestionariosRESUMEN
BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) has poor survival. Current treatments offer little likelihood of cure or long-term survival. This systematic review evaluates prognostic models predicting overall survival in patients diagnosed with PDAC. METHODS: We conducted a comprehensive search of eight electronic databases from their date of inception through to December 2019. Studies that published models predicting survival in patients with PDAC were identified. RESULTS: 3297 studies were identified; 187 full-text articles were retrieved and 54 studies of 49 unique prognostic models were included. Of these, 28 (57.1%) were conducted in patients with advanced disease, 17 (34.7%) with resectable disease, and four (8.2%) in all patients. 34 (69.4%) models were validated, and 35 (71.4%) reported model discrimination, with only five models reporting values >0.70 in both derivation and validation cohorts. Many (n = 27) had a moderate to high risk of bias and most (n = 33) were developed using retrospective data. No variables were unanimously found to be predictive of survival when included in more than one study. CONCLUSION: Most prognostic models were developed using retrospective data and performed poorly. Future research should validate instruments performing well locally in international cohorts and investigate other potential predictors of survival.
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Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Carcinoma Ductal Pancreático/cirugía , Humanos , Neoplasias Pancreáticas/cirugía , Pronóstico , Estudios Retrospectivos , Neoplasias PancreáticasRESUMEN
BACKGROUND: This study: (i) assessed compliance with a consensus set of quality indicators (QIs) in pancreatic cancer (PC); and (ii) evaluated the association between compliance with these QIs and survival. METHODS: Four years of data were collected for patients diagnosed with PC. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). A multivariable analysis tested the relationship between significant patient and hospital characteristics, patient cluster effects within hospitals and survival. RESULTS: 1061 patients were eligible for this study. Significant association with improved survival were: (i) in the potentially resectable group having adjuvant chemotherapy administered following surgery or a reason documented (HR, 0.29; 95 CI, 0.19-0.46); (ii) in the locally advanced group included having chemotherapy ± chemoradiation, or a reason documented for not undergoing treatment (HR, 0.38; 95 CI, 0.25-0.58); and (iii) in the metastatic disease group included having documented performance status at presentation (HR, 0.65; 95 CI, 0.47-0.89), being seen by an oncologist in the absence of treatment (HR, 0.48; 95 CI, 0.31-0.77), and disease management discussed at a multidisciplinary team meeting (HR, 0.79; 95 CI, 0.64-0.96). CONCLUSION: Capture of a concise data set has enabled quality of care to be assessed.
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Neoplasias Pancreáticas , Australia/epidemiología , Quimioterapia Adyuvante , Humanos , Modelos de Riesgos Proporcionales , Neoplasias PancreáticasRESUMEN
BACKGROUND: The aim of this systematic review is to examine patient-reported outcome measures (PROMs), their attributes and application in patients with pancreatic cancer (PC). METHOD: A systematic literature search was undertaken of articles published to June 2018 to identify PROMs applied in primary studies in PC. Characteristics of the included studies and PROMs were described with identified scales grouped into five domains. The psychometric properties of the identified PROMs were further assessed for reliability and validity among patients with PC. RESULTS: From 1688 studies screened, 170 were included. Almost half (48%) were conducted in patients with unresectable PC; the majority of these (68%) were evaluated in randomized controlled trials. Median questionnaire completion rates fell below 10% of the original cohort within 12 months in patients with unresectable PC compared to 75% in patients with resectable PC. Seventy PROMs were identified, 32 measuring unidimensional parameters (e.g. pain) and 35 measuring multidimensional (e.g. quality of life) constructs. Only five (7%) PROMs were disease-specific and 13 (19%) were validated in patients with PC. Fifty scales were grouped into 19 physical, 9 psychological, 6 psychiatric, 9 social and 7 other domains. CONCLUSION: Three multidimensional PROMs, the: (i) FACT-HEP in unresectable PC; (ii) QLQ-PAN26 (in conjunction with its core QLQ-C30 PROM) in resectable PC; and (iii) MDASI-GI are recommended as instruments to capture quality of life in patients with PC. Summarised scales and psychometric evaluation provide a framework to choose PROMs for scales not captured by the recommended PROMs.
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Neoplasias Pancreáticas/terapia , Medición de Resultados Informados por el Paciente , Humanos , Neoplasias Pancreáticas/psicología , Valor Predictivo de las Pruebas , Psicometría , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Best practise care optimises survival and quality of life in patients with pancreatic cancer (PC), but there is evidence of variability in management and suboptimal care for some patients. Monitoring practise is necessary to underpin improvement initiatives. We aimed to develop a core set of quality indicators that measure quality of care across the disease trajectory. METHODS: A modified, three-round Delphi survey was performed among experts with wide experience in PC care across three states in Australia. A total of 107 potential quality indicators were identified from the literature and divided into five areas: diagnosis and staging, surgery, other treatment, patient management and outcomes. A further six indicators were added by the panel, increasing potential quality indicators to 113. Rated on a scale of 1-9, indicators with high median importance and feasibility (score 7-9) and low disagreement (<1) were considered in the candidate set. RESULTS: From 113 potential quality indicators, 34 indicators met the inclusion criteria and 27 (7 diagnosis and staging, 5 surgical, 4 other treatment, 5 patient management, 6 outcome) were included in the final set. CONCLUSIONS: The developed indicator set can be applied as a tool for internal quality improvement, comparative quality reporting, public reporting and research in PC care.
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Técnica Delphi , Neoplasias Pancreáticas/terapia , Indicadores de Calidad de la Atención de Salud , Australia , Consenso , Femenino , Humanos , Masculino , Estadificación de Neoplasias , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/patología , Calidad de VidaRESUMEN
BACKGROUND: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs). OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs' implementation in CQRs, which is the aim of the broader project. METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs' implementation will be extracted. A narrative synthesis of included publications will be conducted. RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024. CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs' implementation in CQRs. TRIAL REGISTRATION: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52572.
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Lista de Verificación , Medición de Resultados Informados por el Paciente , Humanos , Proyectos de Investigación/normas , Guías como AsuntoRESUMEN
BACKGROUND: While there is increasing evidence on the benefits of PROMs in cancer care, the extent of routine collection and use of PROMs in clinical cancer practice across Australia and New Zealand (ANZ) is unknown. This study examined the prevalence and characteristics of PROMs use in routine clinical cancer care in ANZ. METHODS: An online survey was designed and disseminated via professional societies and organisations using a snowball sampling approach to clinical and health administration professionals managing cancer care in ANZ. A poster advertising the study was also circulated on professional social media networks via LinkedIn and Twitter inviting health professionals from ANZ to participate if they were using or intending to use PROMs in clinical cancer practice. Responders opted into the survey via the survey link. RESULTS: From 132 survey views, 91(response rate, 69%) respondents from 56 clinical practices across ANZ agreed to participate in the survey, and of these 55 (n = 55/91, 60%) respondents reported collecting PROMs within their clinical practice. The majority of the respondents were from the State of New South Wales in Australia (n = 21/55, 38%), hospital (n = 35/55, 64%), and a public setting (n = 46/55, 83%). PROMs were collected in all cancer types (n = 21/36, 58%), in all stages of the disease (n = 31/36, 86%), in an adult population (n = 33/36, 92%), applied in English (n = 33/36, 92%), and used to facilitate communication with other reasons (27/36, 75%). A geospatial map analysis provided insights into the variation in PROMs uptake between the two countries and in certain jurisdictions within Australia. This study also highlights the limited resources for PROMs implementation, and a lack of systematic priority driven approach. CONCLUSION: PROM use across Australia and New Zealand seems variable and occurring predominantly in larger metropolitan centres with limited standardisation of approach and implementation. A greater focus on equitable adoption of PROMs in diverse cancer care settings is urgently needed.
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Oncología Médica , Medición de Resultados Informados por el Paciente , Adulto , Humanos , Nueva Zelanda/epidemiología , Australia/epidemiología , Nueva Gales del SurRESUMEN
Although there are several established international guidelines on the management of hepatocellular carcinoma (HCC), there is limited information detailing specific indicators of good quality care. The aim of this study was to develop a core set of quality indicators (QIs) to underpin the management of HCC. We undertook a modified, two-round, Delphi consensus study comprising a working group and experts involved in the management of HCC as well as consumer representatives. QIs were derived from an extensive review of the literature. The role of the participants was to identify the most important and measurable QIs for inclusion in an HCC clinical quality registry. From an initial 94 QIs, 40 were proposed to the participants. Of these, 23 QIs ultimately met the inclusion criteria and were included in the final set. This included (a) nine related to the initial diagnosis and staging, including timing to diagnosis, required baseline clinical and laboratory assessments, prior surveillance for HCC, diagnostic imaging and pathology, tumor staging, and multidisciplinary care; (b) thirteen related to treatment and management, including role of antiviral therapy, timing to treatment, localized ablation and locoregional therapy, surgery, transplantation, systemic therapy, method of response assessment, and supportive care; and (c) one outcome assessment related to surgical mortality. Conclusion: We identified a core set of nationally agreed measurable QIs for the diagnosis, staging, and management of HCC. The adherence to these best practice QIs may lead to system-level improvement in quality of care and, ultimately, improvement in patient outcomes, including survival.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Técnica Delphi , Indicadores de Calidad de la Atención de Salud , Carcinoma Hepatocelular/diagnóstico , Neoplasias Hepáticas/diagnóstico , AntiviralesRESUMEN
OBJECTIVE: To review the evidence on the effectiveness of public health measures in reducing the incidence of covid-19, SARS-CoV-2 transmission, and covid-19 mortality. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, CINAHL, Biosis, Joanna Briggs, Global Health, and World Health Organization COVID-19 database (preprints). ELIGIBILITY CRITERIA FOR STUDY SELECTION: Observational and interventional studies that assessed the effectiveness of public health measures in reducing the incidence of covid-19, SARS-CoV-2 transmission, and covid-19 mortality. MAIN OUTCOME MEASURES: The main outcome measure was incidence of covid-19. Secondary outcomes included SARS-CoV-2 transmission and covid-19 mortality. DATA SYNTHESIS: DerSimonian Laird random effects meta-analysis was performed to investigate the effect of mask wearing, handwashing, and physical distancing measures on incidence of covid-19. Pooled effect estimates with corresponding 95% confidence intervals were computed, and heterogeneity among studies was assessed using Cochran's Q test and the I2 metrics, with two tailed P values. RESULTS: 72 studies met the inclusion criteria, of which 35 evaluated individual public health measures and 37 assessed multiple public health measures as a "package of interventions." Eight of 35 studies were included in the meta-analysis, which indicated a reduction in incidence of covid-19 associated with handwashing (relative risk 0.47, 95% confidence interval 0.19 to 1.12, I2=12%), mask wearing (0.47, 0.29 to 0.75, I2=84%), and physical distancing (0.75, 0.59 to 0.95, I2=87%). Owing to heterogeneity of the studies, meta-analysis was not possible for the outcomes of quarantine and isolation, universal lockdowns, and closures of borders, schools, and workplaces. The effects of these interventions were synthesised descriptively. CONCLUSIONS: This systematic review and meta-analysis suggests that several personal protective and social measures, including handwashing, mask wearing, and physical distancing are associated with reductions in the incidence covid-19. Public health efforts to implement public health measures should consider community health and sociocultural needs, and future research is needed to better understand the effectiveness of public health measures in the context of covid-19 vaccination. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020178692.
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COVID-19/epidemiología , COVID-19/prevención & control , Control de Enfermedades Transmisibles/métodos , Salud Pública , COVID-19/mortalidad , COVID-19/transmisión , Vacunas contra la COVID-19/uso terapéutico , Salud Global , Desinfección de las Manos/métodos , Humanos , Incidencia , Máscaras , Distanciamiento Físico , Cuarentena/métodos , SARS-CoV-2 , Instituciones Académicas , Viaje , Organización Mundial de la SaludRESUMEN
BACKGROUND: Evidence-based clinical practice guidelines recommend discussion by a multidisciplinary team (MDT) to review and plan the management of patients for a variety of cancers. However, not all patients diagnosed with cancer are presented at an MDT. OBJECTIVES: (1) To identify the factors (barriers and enablers) influencing presentation of all patients to, and the perceived value of, MDT meetings in the management of patients with pancreatic cancer and; (2) to identify potential interventions that could overcome modifiable barriers and enhance enablers using the theoretical domains framework (TDF). METHODS: Semistructured interviews were conducted with radiologists, surgeons, medical and radiation oncologists, gastroenterologists, palliative care specialists and nurse specialists based in New South Wales and Victoria, Australia. Interviews were conducted either in person or via videoconferencing. All interviews were recorded, transcribed verbatim, deidentified and data were thematically coded according to the 12 domains explored within the TDF. Common belief statements were generated to compare the variation between participant responses. RESULTS: In total, 29 specialists were interviewed over a 4-month period. Twenty-two themes and 40 belief statements relevant to all the TDF domains were generated. Key enablers influencing MDT practices included a strong organisational focus (social/professional role and identity), beliefs about the benefits of an MDT discussion (beliefs about consequences), the use of technology, for example, videoconferencing (environmental context and resources), the motivation to provide good quality care (motivation and goals) and collegiality (social influences). Barriers included: absence of palliative care representation (skills), the number of MDT meetings (environmental context and resources), the cumulative cost of staff time (beliefs about consequences), the lack of capacity to discuss all patients within the allotted time (beliefs about capabilities) and reduced confidence to participate in discussions (social influences). CONCLUSIONS: The internal and external organisational structures surrounding MDT meetings ideally need to be strengthened with the development of agreed evidence-based protocols and referral pathways, a focus on resource allocation and capabilities, and a culture that fosters widespread collaboration for all stages of pancreatic cancer.
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Motivación , Rol Profesional , Humanos , Grupo de Atención al Paciente , Investigación Cualitativa , VictoriaRESUMEN
BACKGROUND: Accurate pre-operative imaging plays a vital role in patient selection for surgery and in allocating stage-appropriate therapies to patients diagnosed with pancreatic cancer (PC). This study aims to: (1) understand the current diagnosis and staging practices for PC; and (2) explore the factors (barriers and enablers) that influence the use of a pancreatic protocol computed tomography (PPCT) or magnetic resonance imaging (MRI) to confirm diagnosis and/or accurately stage PC. METHODS: Semi-structured interviews were conducted with radiologists, surgeons, gastroenterologists, medical and radiation oncologists from the states of New South Wales (NSW) and Victoria, Australia. Interviews were conducted either in person or via video conferencing. All interviews were recorded, transcribed verbatim, de-identified and data were thematically coded according to the 12 domains explored within the Theoretical Domains Framework (TDF). Common belief statements were generated to compare the variation between participant responses. FINDINGS: In total, 21 clinicians (5 radiologists, 10 surgeons, 2 gastroenterologists, 4 medical and radiation oncologists) were interviewed over a four-month-period. Belief statements relevant to the TDF domains were generated. Across the 11 relevant domains, 20 themes and 30 specific beliefs were identified. All TDF domains, with the exception of social influences were identified by participants as relevant to protocol-based imaging using either a PPCT or MRI, with the domains of knowledge, skills and environmental context and resources being offered by most participants as being relevant in influencing their decisions. CONCLUSIONS: To maximise outcomes and personalise therapy it is imperative that diagnosis and staging investigations using the most appropriate imaging modalities are conducted in a timely, efficient and effective manner. The results provide an understanding of specialists' opinion and behaviour in relation to a PPCT or MRI and should be used to inform the design of future interventions to improve compliance with this practice.
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Imagen por Resonancia Magnética , Neoplasias Pancreáticas/diagnóstico por imagen , Medicina de Precisión , Tomografía Computarizada por Rayos X , Femenino , Humanos , Masculino , Estadificación de Neoplasias , Investigación CualitativaRESUMEN
PURPOSE: Patient-centred and value-based health-care organisations are increasingly recognising the importance of the patient perspective in the measurement and evaluation of health outcomes. This has been primarily implemented using patient-reported outcome measures (PROMs). Clinical quality registries (CQRs) are specifically designed to improve direct clinical care, benchmark health-care provision and inform health service planning and policy. Despite CQRs having incorporated the patient perspective to support the evaluation of health-care provision, no evidence-based guidelines for inclusion of PROMs in CQRs exist. This has led to substantial heterogeneity in capturing and reporting PROMs within this setting. This publication is the first in a series describing the development of evidence-informed guidelines for PROMs inclusion within CQRs in Australia. METHODS: This study consisted of three components: 1) a literature review of existing evidence of guidelines, enablers, barriers, and lessons learnt of PROMs use within the CQRs setting; 2) a survey of Australian CQRs to determine current practices for PROMs use and reporting; and 3) development of a preliminary conceptual framework for PROMs inclusion in CQRs. RESULTS: Content analysis of the literature review and survey of 66 Australian registries elicited eight categories for the conceptual framework. The framework covers eight components: rationale, setting, ethics, selection of PROMs, administration, data management, statistical methods, feedback, and reporting. CONCLUSION: We developed a preliminary conceptual framework, which classified findings, from both the literature and the survey, into broad categories ranging from initial development to outcome dissemination providing the structure for development of guidelines in the next phase of this project, engaging national and international leaders in health-related quality of life research, clinicians, researchers, patient advocates and consumers.
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PURPOSE: The Upper Gastrointestinal Cancer Registry (UGICR) was developed to monitor and improve the quality of care provided to patients with upper gastrointestinal cancers in Australia. PARTICIPANTS: It supports four cancer modules: pancreatic, oesophagogastric, biliary and primary liver cancer. The pancreatic cancer (PC) module was the first module to be implemented, with others being established in a staged approach. Individuals are recruited to the registry if they are aged 18 years or older, have received care for their cancer at a participating public/private hospital or private clinic in Australia and do not opt out of participation. FINDINGS TO DATE: The UGICR is governed by a multidisciplinary steering committee that provides clinical governance and oversees clinical working parties. The role of the working parties is to develop quality indicators based on best practice for each registry module, develop the minimum datasets and provide guidance in analysing and reporting of results. Data are captured from existing data sources (population-based cancer incidence registries, pathology databases and hospital-coded data) and manually from clinical records. Data collectors directly enter information into a secure web-based Research Electronic Data Capture (REDCap) data collection platform. The PC module began with a pilot phase, and subsequently, we used a formal modified Delphi consensus process to establish a core set of quality indicators for PC. The second module developed was the oesophagogastric cancer (OGC) module. Results of the 1 year pilot phases for PC and OGC modules are included in this cohort profile. FUTURE PLANS: The UGICR will provide regular reports of risk-adjusted, benchmarked performance on a range of quality indicators that will highlight variations in care and clinical outcomes at a health service level. The registry has also been developed with the view to collect patient-reported outcomes (PROs), which will further add to our understanding of the care of patients with these cancers.
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Neoplasias Gastrointestinales/terapia , Sistema de Registros , Anciano , Anciano de 80 o más Años , Australia/epidemiología , Neoplasias del Sistema Biliar/epidemiología , Neoplasias del Sistema Biliar/terapia , Neoplasias Esofágicas/epidemiología , Neoplasias Esofágicas/terapia , Femenino , Neoplasias Gastrointestinales/epidemiología , Humanos , Neoplasias Hepáticas/epidemiología , Neoplasias Hepáticas/terapia , Masculino , Persona de Mediana Edad , Neoplasias Pancreáticas/epidemiología , Neoplasias Pancreáticas/terapia , Mejoramiento de la Calidad , Neoplasias Gástricas/epidemiología , Neoplasias Gástricas/terapiaRESUMEN
AIM: The purpose of this study is to identify patterns of medication-related harm from a national perspective, and to use this information to inform decisions on where to focus medication safety efforts. This study updates a 2013 study using the same methodology. METHOD: District health boards (DHBs) still actively using either the Adverse Drug Event (ADE) Trigger Tool (TT) or the Global Trigger Tool (GTT), submitted two years of anonymised ADE data (1 July 2013-30 June 2015) to the Health Quality & Safety Commission (the Commission) using a standard template. Analyses were conducted using aggregated data only. RESULTS: Of eight DHBs who submitted data, six datasets were included, representing a total of 2,659 chart reviews. From these reviews, 923 harms were identified in 751 patients, with 28% of patients experiencing one or more harms. Harms occurred at a rate of 34.7 per 100 admissions, 42.5 per 1,000 bed days and 28% of patients experienced one or more medication-related harms. Those harmed were more likely to be older, female and have an increased length of stay. Most harms (65%) occurred during an inpatient stay, however, a substantial number (29%) originated in the community and precipitated an admission. Across all levels of severity, the most common types of medication harm were constipation, hypotension and bleeding. In the more serious harm categories, bleeding, hypotension and delirium/confusion/over-sedation were most common. Six groups of medicines caused the greatest amount of harm: opioids (including tramadol), anticoagulants/antiplatelet agents, antibiotics, antianginals (beta-blockers, nitrates, calcium channel blockers and others), diuretics and other cardiovascular medicines (angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), centrally acting agents and statins). Opioids and anticoagulants/antiplatelet agents not only accounted for 40% of all harm, they were implicated in the most severe harm. CONCLUSION: This paper confirms earlier work that medication-related harms are common, occur both in hospitals and in the community, and are a substantial burden for patients and our healthcare system. Work is underway at local and national levels to decrease this harm, with a focus on the high-risk medicines most commonly implicated.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Daño del Paciente/estadística & datos numéricos , Adulto , Analgésicos Opioides/efectos adversos , Anticoagulantes/efectos adversos , Estreñimiento/inducido químicamente , Femenino , Hemorragia/inducido químicamente , Hospitales , Humanos , Hipotensión/inducido químicamente , Tiempo de Internación , Masculino , Persona de Mediana Edad , Nueva Zelanda , Características de la Residencia , Índice de Severidad de la EnfermedadRESUMEN
AIM: To measure the extent of patient harm caused by medications (rate of Adverse Drug Events) in three DHBs, using a standardised trigger tool method. METHODS: Counties Manukau, Capital and Coast and Canterbury DHBs decided to work collaboratively to implement the ADE Trigger Tool (TT). Definitions of ADE were agreed on and triggers refined. A random sample of closed charts (from March 2010 to February 2011) was obtained excluding patients who were admitted for <48 hours, children under the age of 18 and psychiatric admissions. In each DHB trained reviewers scanned these in a structured way to identify any of the 19 triggers. If triggers were identified, a more detailed, though time-limited review of the chart was done to determine whether an ADE had occurred. The severity of patient harm was categorised using the National Coordinating Council for Medication Error Reporting and Prevention Index. No attempt was made to determine preventability of harm and ADEs from acts of omission were excluded. RESULTS: The ADE TT was applied to 1210 charts and 353 ADE were identified, with an average rate of 28.9/100 admissions and 38/1,000 bed days. 94.5% of the ADE identified were in the lower severity scales with temporary harm, however in 5 patients it was considered that the ADE contributed to their death, 9 required an intervention to sustain life and 4 suffered permanent harm. The most commonly implicated drugs were morphine and other opioids, anticoagulants, antibiotics, Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and diuretics. Patients who suffered an ADE were more likely to be female, older with more complex medical illnesses, and have a longer length of stay. CONCLUSION: The rate of medication-related harm identified by the ADE TT is considerably higher than that identified through traditional voluntary reporting mechanisms. The ADE TT provides a standardised measure of harm over time that can be used to determine trends and the effect of medication safety improvement programmes. This study not only shows the problem of medication-related patient harm, but it also shows the utility of informal collaboratives as a mechanism for change.