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Geographic Influences on Appendicectomy Outcomes

16 de diciembre de 2013 actualizado por: University of Edinburgh

Introduction

Appendicitis is a common condition which represents a significant resource burden for the Scottish National Health Service (NHS). It is unknown whether there are significant differences in outcomes following appendicectomy which may be explained by geographic factors.

Aims

The aim of this study is to describe appendicectomy outcomes in Scotland as they vary by the urban-rural nature of the patient's home location and travel time from hospital.

Methods

This research study is a retrospective observational enquiry which will utilise administrative data from the Information Services Division (ISD) of NHS National Services Scotland. Patient episodes will be identified by a procedure code for appendicectomy, and the urban-rural classification of patients will be derived from postcode data. Travel time from hospital will also be estimated through postcode data. The investigators will study a 10 year period from January 2001 to December 2010.

Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rates.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The aim of this study is to explore the possibility that outcome from appendicectomy may vary according to:

  1. the urban-rural nature of the patient's home location and
  2. travel time from hospital.

This is a retrospective study of all appendicectomies performed in Scotland during the period from 1st January 2001 - 31st December 2010. It will use routinely collected administrative data from the Information Services Division (ISD) of NHS National Services Scotland.

Potentially significant confounding variables such as age, gender, and co-morbidity will be studied for their predictive value in a univariate model and included in a multivariate model if they remain significant.

There is no single appendicectomy outcome measure which is a literature standard, so all of the following will be evaluated as primary outcome measures: risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rates.

The registry which will supply the data for this study is the Scottish Morbidity Record 01 (SMR01), the full title of which is the "General / Acute Inpatient and Day Case dataset" (see http://www.adls.ac.uk/nhs-scotland/general-acute-inpatient-day-case-smr01/?detail). SMR01 is collated and administered by ISD, and data submission is mandatory for all Scottish NHS providers of in-patient or day-case care. Approximately 1.4 million records are added each year. Diagnoses are coded according to International Classification of Diseases (ICD)-10 standards and procedures are coded according to the United Kingdom's Office of Population Census Statistics (OPCS) standards, the most recent of which is version 4.5.

The data quality in SMR01 is high and is assured by regular internal audits. In the 2010 audit of accuracy, Main Condition was recorded with an accuracy of 88% and Main Procedure was recorded with an accuracy of 94%. Where data inconsistencies are identified in the extract supplied for this study, further clarification will be obtained where possible with ISD's data retrieval support team. Data completeness is very high in SMR01. However, where significant volumes of data are missing or unusable, the need for data imputation will be explored.

The study period was decided on pragmatically by a desire to provide an assessment of current practice, fully within the era of widely practised laparoscopic surgery. A power calculation also suggested that this would provide an adequate sample size to demonstrate differences.

Our power calculation- specific to length of stay- was based on Faiz O, Clark J, Brown T, Bottle A, Antoniou A, Farrands P, et al. Traditional and Laparoscopic Appendectomy in Adults. Ann Surg. 2008 Nov;248(5):800-6. In their cohort of 259,735 appendicectomies performed from 1996-2006, the geometric mean length of stay was 3.52, with SD 1.8. We decided that a difference of 0.5 days would be 'clinically significant'. We specified alpha 0.05 and Power 0.9, and an allocation ratio of 2 (allowing comparison of one tertile to two others). A two-sided t-test of difference between two independent means was performed in G*Power 3.1.7. This demonstrated that a total N of 616 was required to demonstrate this difference. According to ISD figures, there were 3,712 appendicectomy procedures performed in 2010/11, so with numbers available we will be able to detect a clinically significant difference in length of stay.

The investigators will use the Scottish government's own 8-fold urban-rural classification system (see http://www.scotland.gov.uk/Topics/Statistics/About/Methodology/UrbanRuralClassification) to investigate the possible relationship between patient geographical location and outcome. Urban-rural categories may be grouped for analysis, depending on initial exploratory work.

The investigators will further calculate the approximate travelling time from patient home location (using postcode) to the treating hospital, by constructing isochrones at time/distance intervals from hospitals. Travel time will be evaluated as a continuous and discrete variable.

Tipo de estudio

De observación

Inscripción (Anticipado)

40000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • All Scottish surgical facilities, Reino Unido
        • All Scottish NHS Hospitals

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

All Scottish residents undergoing appendicectomy during the study period.

Descripción

Inclusion Criteria:

  • All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 - December 2010.

Exclusion Criteria:

  • Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure.
  • Patients non-resident in Scotland.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Urbano-Rural Clasificación 3: Pueblos Pequeños Accesibles
Asentamientos de entre 3.000 y 10.000 personas y dentro de los 30 minutos en coche de un asentamiento de 10.000 o más.
Urbano-Rural Clasificación 4: Pueblos Pequeños Remotos
Asentamientos de entre 3.000 y 10.000 personas y con un tiempo de conducción de más de 30 minutos a un asentamiento de 10.000 o más.
Urban-Rural Classification 1: Large Urban Areas
Settlements of over 125,000 people.
Urban-Rural Classification 2: Other Urban Areas
Settlements of 10,000 to 125,000 people.
Urban-Rural Classification 5: Very Remote Small Towns
Settlements of between 3,000 and 10,000 people and with a drive time of over 60 minutes to a settlement of 10,000 or more.
Urban-Rural Classification 6: Accessible Rural
Areas with a population of less than 3,000 people, and within a 30 minute drive time of a settlement of 10,000 or more.
Urban-Rural Classification 7: Remote Rural
Areas with a population of less than 3,000 people, and with a drive time of over 30 minutes to a settlement of 10,000 or more.
Urban-Rural Classification 8: Very Remote Rural
Areas with a population of less than 3,000 people, and with a drive time of over 60 minutes to a settlement of 10,000 or more.
Travel Time - see below
Travel time will be analysed as both a continuous and discrete variable.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Post-operative length of stay
Periodo de tiempo: From date of appendicectomy to date of discharge (whole days) - see below
(Whole) days from date of laparotomy to date of discharge. Because this is a retrospective study using a complete national data set, with the last admission 2.5 years distant from the time of data collection, we will use actual time period rather than censoring length of stay at a set point.
From date of appendicectomy to date of discharge (whole days) - see below
Re-operation
Periodo de tiempo: Within the index admission or within 30 days of discharge
The occurrence of an abdominal procedure either subsequent to appendicectomy and within the index admission, or ≤30 days of discharge.
Within the index admission or within 30 days of discharge
Readmisión
Periodo de tiempo: Dentro de los 30 días del alta índice
Haber transcurrido ≤ 30 días desde la fecha de alta desde la fecha de reingreso a cualquier especialidad hospitalaria.
Dentro de los 30 días del alta índice
Mortalidad
Periodo de tiempo: Ya sea dentro de los 30 días posteriores al procedimiento o durante la estadía continua como paciente hospitalizado
Muerte como paciente hospitalizado o ≤30 días del procedimiento. Las muertes se reconocerán a partir de SMR01, que está vinculado a la base de datos de muertes del Registrador General.
Ya sea dentro de los 30 días posteriores al procedimiento o durante la estadía continua como paciente hospitalizado
Negative Appendicectomy Rate
Periodo de tiempo: At time of index procedure
The rate of appendicectomies performed in which the appendix is found to be normal. This will be detected by the use of ICD-10 codes.
At time of index procedure

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2001

Finalización primaria (Actual)

1 de diciembre de 2010

Finalización del estudio (Actual)

1 de agosto de 2013

Fechas de registro del estudio

Enviado por primera vez

21 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

16 de diciembre de 2013

Publicado por primera vez (Estimar)

23 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de diciembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

16 de diciembre de 2013

Última verificación

1 de diciembre de 2013

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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