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BACKGROUND: The diagnosis, management and prognosis of microinvasive breast carcinoma remain controversial. METHODS: We analysed the outcomes of patients with DCIS with and without microinvasion diagnosed between 2003 and 2012 within the Sloane project. RESULTS: Microinvasion was recorded in 521 of 11,285 patients (4.6%), with considerable variation in reported incidence among screening units (0-25%). Microinvasion was associated with high-grade DCIS, larger DCIS size, comedo necrosis and solid, cribriform architecture (all P < 0.001). Microinvasion was more frequent in patients who underwent mastectomy compared with breast-conserving surgery (BCS) (6.9% vs 3.6%, P < 0.001), and in those undergoing axillary nodal surgery (60.4% vs 30.3%, P < 0.001) including the subset undergoing BCS (43.4% vs 8.5%, P < 0.001). Nodal metastasis rate was low and not statistically significant difference from the DCIS only group (P = 0.68). Following median follow-up of 110 months, 3% of patients had recurrent ipsilateral high-grade DCIS, and 4.2% developed invasive carcinoma. The subsequent ipsilateral invasion was of Grade 3 in 71.4% of patients with microinvasion vs 30.4% in DCIS without microinvasion (P = 0.02). Distant metastasis and breast cancer mortality were higher with microinvasion compared with DCIS only (1.2% vs 0.3%, P = 0.01 and 2.1% vs 0.8%; P = 0.005). CONCLUSIONS: The higher breast cancer mortality with microinvasion indicates a more aggressive disease.
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Neoplasias de la Mama , Carcinoma Intraductal no Infiltrante , Humanos , Femenino , Carcinoma Intraductal no Infiltrante/cirugía , Neoplasias de la Mama/cirugía , Mastectomía , Reino UnidoRESUMEN
OBJECTIVES: There is considerable interest in reducing the cost of clinical trials. Linkage of trial data to administrative datasets and disease-specific registries may improve trial efficiency, but it has not been reported in resuscitation trials conducted in the UK. To assess the feasibility of using national administrative and clinical datasets to follow up patients transported to hospital following attempted resuscitation in a cluster randomised trial of a mechanical chest compression device in out-of-hospital cardiac arrest. METHODS: Hospital data on trial participants were requested from Hospital Episode Statistics (HES), the Intensive Care National Audit and Research Centre, and Myocardial Ischaemia National Audit Project and National Audit of Percutaneous Coronary Interventions, using unique patient identifiers. Linked data were received between June 2014 and June 2015. RESULTS: Of 4471 patients randomised in the pre-hospital randomised assessment of a mechanical compression device in cardiac arrest (PARAMEDIC) trial, 2398 (53.6%) were not known to be deceased at emergency department arrival and were eligible for linkage. We achieved an overall match rate of 86.7% in the combined HES accident and emergency, inpatient and critical care dataset, with variable match rates (4.2%-80.4%) in individual datasets. Patient demographics, cardiac arrest-related characteristics and major outcomes were predominantly similar between HES matched and unmatched groups, in the linkage apart from location, response time and return of spontaneous circulation (ROSC) at handover. CONCLUSIONS: This study shows that it is feasible to track patients from the prehospital setting through to hospital admission using routinely available administrative datasets with a moderate to high degree of success. This approach has the potential to complement the trial data with the demographic and clinical management information about the studied cohort, as well as to improve the efficiency and reduce the costs of follow-up in cardiac arrest trials. CLINICAL TRIAL REGISTRATION: ISRCTN08233942; Post-results.
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Reanimación Cardiopulmonar/métodos , Servicios Médicos de Urgencia , Auxiliares de Urgencia/organización & administración , Masaje Cardíaco , Paro Cardíaco Extrahospitalario/terapia , Análisis por Conglomerados , Estudios de Factibilidad , Humanos , Almacenamiento y Recuperación de la Información , Paro Cardíaco Extrahospitalario/mortalidad , Sistema de RegistrosRESUMEN
OBJECTIVES: The Out-of-Hospital Cardiac Arrest Outcomes (OHCAO) project aims to understand the epidemiology and outcomes of out-of-hospital cardiac arrest (OHCA) across the UK. This data linkage study is a subproject of OHCAO. The aim was to establish the feasibility of linking OHCAO data to National Health Service (NHS) patient demographic data and Office for National Statistics (ONS) date of death data held on the NHS Personal Demographics Service (PDS) database to improve OHCAO demographic data quality and enable analysis of 30-day survival from OHCA. DESIGN AND SETTING: Data were collected from 1 January 2014 to 31 December 2014 as part of a prospective, observational study of OHCA attended by 10 English NHS Ambulance Services. 28 729 OHCA cases had resuscitation attempted by Emergency Medical Services and were included in the study. Data linkage was carried out using a data linkage service provided by NHS Digital, a national provider of health-related data. To assess data linkage feasibility a random sample of 3120 cases was selected. The sample was securely transferred to NHS Digital to be matched using OHCAO patient demographic data to return previously missing demographic data and provide ONS date of death data. RESULTS: A total of 2513 (80.5%) OHCAO cases were matched to patients in the NHS PDS database. Using the linkage process, missing demographic data were retrieved for 1636 (72.7%) out of 2249 OHCAO cases that had previously incomplete demographic data. Returned ONS date of death data allowed analysis of 30-day survival status. The results showed a 30-day survival rate of 9.3%, reducing unknown survival status from 46.1% to 8.5%. CONCLUSIONS: In this sample, data linkage between the OHCAO registry and NHS PDS database was shown to be feasible, improving demographic data quality and allowing analysis of 30-day survival status.
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Exactitud de los Datos , Almacenamiento y Recuperación de la Información/métodos , Paro Cardíaco Extrahospitalario/epidemiología , Tasa de Supervivencia , Bases de Datos como Asunto , Estudios de Factibilidad , Humanos , Paro Cardíaco Extrahospitalario/mortalidad , Estudios Prospectivos , Sistema de Registros , Medicina Estatal , Reino Unido/epidemiologíaRESUMEN
There is growing recognition that involving patients in the development of new patient-reported outcome measures helps ensure that the outcomes that matter most to people living with health conditions are captured. Here, we describe and discuss different experiences of integrating patients as full patient research partners (PRPs) in outcomes research from multiple perspectives (e.g., researcher, patient, and funder), drawing from three real-world examples. These diverse experiences highlight the strengths, challenges, and impact of partnering with patients to conceptualize, design, and conduct research and disseminate findings. On the basis of our experiences, we suggest basic guidelines for outcomes researchers on establishing research partnerships with patients, including: 1) establishing supportive organizational/institutional policies; 2) cultivating supportive attitudes of researchers and PRPs with recognition that partnerships evolve over time, are grounded in strong communication, and have shared goals; 3) adhering to principles of respect, trust, reciprocity, and co-learning; 4) addressing training needs of all team members to ensure communications and that PRPs are conversant in and familiar with the language and process of research; 5) identifying the resources and advanced planning required for successful patient engagement; and 6) recognizing the value of partnerships across all stages of research. The three experiences presented explore different approaches to partnering; demonstrate how this can fundamentally change the way research work is conceptualized, conducted, and disseminated; and can serve as exemplars for other forms of patient-centered outcomes research. Further work is needed to identify the skills, qualities, and approaches that best support effective patient-researcher partnerships.
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Evaluación del Resultado de la Atención al Paciente , Participación del Paciente , Relaciones Investigador-Sujeto , Actitud , Guías como Asunto , Humanos , Organizaciones sin Fines de Lucro , Investigación , Encuestas y CuestionariosRESUMEN
INTRODUCTION: This study reports the epidemiology and outcomes from out-of-hospital cardiac arrest (OHCA) in England during 2014. METHODS: Prospective observational study from the national OHCA registry. The incidence, demographic and outcomes of patients who were treated for an OHCA between 1st January 2014 and 31st December 2014 in 10 English ambulance service (EMS) regions, serving a population of almost 54 million, are reported in accordance with Utstein recommendations. RESULTS: 28,729 OHCA cases of EMS treated cardiac arrests were reported (53 per 100,000 of resident population). The mean age was 68.6 (SD=19.6) years and 41.3% were female. Most (83%) occurred in a place of residence, 52.7% were witnessed by either the EMS or a bystander. In non-EMS witnessed cases, 55.2% received bystander CPR whilst public access defibrillation was used rarely (2.3%). Cardiac aetiology was the leading cause of cardiac arrest (60.9%). The initial rhythm was asystole in 42.4% of all cases and was shockable (VF or pVT) in 20.6%. Return of spontaneous circulation at hospital transfer was evident in 25.8% (n=6302) and survival to hospital discharge was 7.9%. CONCLUSION: Cardiac arrest is an important cause of death in England. With less than one in ten patients surviving, there is scope to improve outcomes. Survival rates were highest amongst those who received bystander CPR and public access defibrillation.
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Reanimación Cardiopulmonar , Servicios Médicos de Urgencia , Cardiopatías , Paro Cardíaco Extrahospitalario , Adulto , Anciano , Reanimación Cardiopulmonar/métodos , Reanimación Cardiopulmonar/estadística & datos numéricos , Demografía , Servicios Médicos de Urgencia/métodos , Servicios Médicos de Urgencia/estadística & datos numéricos , Inglaterra/epidemiología , Femenino , Cardiopatías/complicaciones , Cardiopatías/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Evaluación de Necesidades , Paro Cardíaco Extrahospitalario/etiología , Paro Cardíaco Extrahospitalario/mortalidad , Paro Cardíaco Extrahospitalario/terapia , Evaluación de Procesos y Resultados en Atención de Salud , Alta del Paciente/estadística & datos numéricos , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Tasa de SupervivenciaRESUMEN
PURPOSE: Active patient engagement is increasingly viewed as essential to ensuring that patient-driven perspectives are considered throughout the research process. However, guidance for patient engagement (PE) in HRQoL research does not exist, the evidence-base for practice is limited, and we know relatively little about underpinning values that can impact on PE practice. This is the first study to explore the values that should underpin PE in contemporary HRQoL research to help inform future good practice guidance. METHODS: A modified 'World Café' was hosted as a collaborative activity between patient partners, clinicians and researchers: self-nominated conference delegates participated in group discussions to explore values associated with the conduct and consequences of PE. Values were captured via post-it notes and by nominated note-takers. Data were thematically analysed: emergent themes were coded and agreement checked. Association between emergent themes, values and the Public Involvement Impact Assessment Framework were explored. RESULTS: Eighty participants, including 12 patient partners, participated in the 90-min event. Three core values were defined: (1) building relationships; (2) improving research quality and impact; and (3) developing best practice. Participants valued the importance of building genuine, collaborative and deliberative relationships-underpinned by honesty, respect, co-learning and equity-and the impact of effective PE on research quality and relevance. CONCLUSIONS: An explicit statement of values seeks to align all stakeholders on the purpose, practice and credibility of PE activities. An innovative, flexible and transparent research environment was valued as essential to developing a trustworthy evidence-base with which to underpin future guidance for good PE practice.
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Estado de Salud , Internacionalidad , Participación del Paciente , Calidad de Vida , Proyectos de Investigación , HumanosRESUMEN
OBJECTIVE: Early identification of sepsis could enable prompt delivery of key interventions such as fluid resuscitation and antibiotic administration which, in turn, may lead to improved patient outcomes. Limited data indicate that recognition of sepsis by paramedics is often poor. We systematically reviewed the literature on prehospital sepsis screening tools to determine whether they improved sepsis recognition. DESIGN: Systematic review. The electronic databases MEDLINE, EMBASE, CINAHL, the Cochrane Library and PubMed were systematically searched up to June 2015. In addition, subject experts were contacted. SETTING: Prehospital/emergency medical services (EMS). STUDY SELECTION: All studies addressing identification of sepsis (including severe sepsis and septic shock) among adult patients managed by EMS. OUTCOME MEASURES: Recognition of sepsis by EMS clinicians. RESULTS: Owing to considerable variation in the methodological approach adopted and outcome measures reported, a narrative approach to data synthesis was adopted. Three studies addressed development of prehospital sepsis screening tools. Six studies addressed paramedic diagnosis of sepsis with or without use of a prehospital sepsis screening tool. CONCLUSIONS: Recognition of sepsis by ambulance clinicians is poor. The use of screening tools, based on the Surviving Sepsis Campaign diagnostic criteria, improves prehospital sepsis recognition. Screening tools derived from EMS data have been developed, but they have not yet been validated in clinical practice. There is a need to undertake validation studies to determine whether prehospital sepsis screening tools confer any clinical benefit.
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Diagnóstico Precoz , Servicios Médicos de Urgencia/métodos , Auxiliares de Urgencia , Sepsis/diagnóstico , Adulto , Ambulancias , Fluidoterapia , Humanos , Evaluación de Resultado en la Atención de Salud , Sepsis/terapiaRESUMEN
INTRODUCTION: Sepsis is a common and potentially life-threatening response to an infection. International treatment guidelines for sepsis advocate that treatment be initiated at the earliest possible opportunity. It is not yet clear if very early intervention by ambulance clinicians prior to arrival at hospital leads to improved clinical outcomes among sepsis patients. METHODA: We systematically searched the electronic databases MEDLINE, EMBASE, CINAHL, the Cochrane Library and PubMed up to June 2015. In addition, subject experts were contacted. We adopted the GRADE (grading recommendations assessment, development and evaluation) methodology to conduct the review and follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations to report findings. RESULTS: Nine studies met the eligibility criteria - one study was a randomized controlled trial while the remaining studies were observational in nature. There was considerable variation in the methodological approaches adopted and outcome measures reported across the studies. Because of these differences, the studies did not answer a unique research question and meta-analysis was not appropriate. A narrative approach to data synthesis was adopted. CONCLUSION: There is little robust evidence addressing the impact of prehospital interventions on outcomes in sepsis. That which is available is of low quality and indicates that prehospital interventions have limited impact on outcomes in sepsis beyond improving process outcomes and expediting the patient's passage through the emergency care pathway. Evidence indicating that prehospital antibiotic therapy and fluid resuscitation improve patient outcomes is currently lacking.
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Servicios Médicos de Urgencia , Adhesión a Directriz , Sepsis/terapia , Servicios Médicos de Urgencia/normas , Humanos , Evaluación de Resultado en la Atención de Salud , Guías de Práctica Clínica como Asunto , Pronóstico , Sepsis/diagnóstico , Factores de Tiempo , Estados UnidosRESUMEN
INTRODUCTION: Reducing premature death is a key priority for the UK National Health Service (NHS). NHS Ambulance services treat approximately 30â 000 cases of suspected cardiac arrest each year but survival rates vary. The British Heart Foundation and Resuscitation Council (UK) have funded a structured research programme--the Out of Hospital Cardiac Arrest Outcomes (OHCAO) programme. The aim of the project is to establish the epidemiology and outcome of OHCA, explore sources of variation in outcome and establish the feasibility of setting up a national OHCA registry. METHODS AND ANALYSIS: This is a prospective observational study set in UK NHS Ambulance Services. The target population will be adults and children sustaining an OHCA who are attended by an NHS ambulance emergency response and where resuscitation is attempted. The data collected will be characterised broadly as system characteristics, emergency medical services (EMS) dispatch characteristics, patient characteristics and EMS process variables. The main outcome variables of interest will be return of spontaneous circulation and medium-long-term survival (30â days to 10-year survival). ETHICS AND DISSEMINATION: Ethics committee permissions were gained and the study also has received approval from the Confidentiality Advisory Group Ethics and Confidentiality committee which provides authorisation to lawfully hold identifiable data on patients without their consent. To identify the key characteristics contributing to better outcomes in some ambulance services, reliable and reproducible systems need to be established for collecting data on OHCA in the UK. Reports generated from the registry will focus on data completeness, timeliness and quality. Subsequent reports will summarise demographic, patient, process and outcome variables with aim of improving patient care through focus quality improvement initiatives.