이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Geographic Influences on Appendicectomy Outcomes

2013년 12월 16일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (예상)

40000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • All Scottish surgical facilities, 영국
        • All Scottish NHS Hospitals

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

All Scottish residents undergoing appendicectomy during the study period.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
도시-농촌 분류 3: 접근 가능한 소도시
3,000명에서 10,000명 사이의 정착지와 10,000명 이상의 정착지에서 차로 30분 이내.
도시-농촌 분류 4: 외딴 소도시
3,000명에서 10,000명 사이의 정착지와 10,000명 이상의 정착지까지 운전 시간이 30분 이상 소요됩니다.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Post-operative length of stay
기간: 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
기간: 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
재입학
기간: 지수 배출 후 30일 이내
퇴원일로부터 30일 이하의 병원 전문 분야 재입원.
지수 배출 후 30일 이내
인류
기간: 시술 후 30일 이내 또는 지속적인 입원 기간 동안
입원 환자로서의 사망 또는 ≤30일 시술. 사망은 Registrar General의 사망 데이터베이스에 연결된 SMR01에서 인식됩니다.
시술 후 30일 이내 또는 지속적인 입원 기간 동안
Negative Appendicectomy Rate
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2001년 1월 1일

기본 완료 (실제)

2010년 12월 1일

연구 완료 (실제)

2013년 8월 1일

연구 등록 날짜

최초 제출

2013년 11월 21일

QC 기준을 충족하는 최초 제출

2013년 12월 16일

처음 게시됨 (추정)

2013년 12월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 12월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 12월 16일

마지막으로 확인됨

2013년 12월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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