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Cochrane Database of Systematic Reviews Protocol - Intervention

Spinal injuries units (SIUs) for acute traumatic spinal cord injury

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To answer the question: does immediate referral to a spinal injuries unit (SIU) result in a better outcome than delayed referral?

Background

It is estimated that between 500 and 700 people sustain a traumatic spinal cord injury (SCI) in the UK each year (Smith 1999). In the USA, there are approximately 10,000 new cases per year (McDonald 2002). SCI can occur at any age, the effects are usually permanent and currently there is no cure (Harrison 2000). The modal age of an SCI is 19 years and the lifetime cost of care may consequently be quite high. The average lifetime cost of treating a person with SCI has been estimated at between US$500,000 and US$2 million, depending upon the location and extent of the injury (McDonald 2002). The most common mechanism of injury is a sudden unexpected impact or deceleration (e.g. in a road accident or domestic fall). Further neurological deterioration, resulting from lesion extension after the initial injury can occur naturally in about 5% of cases (Harrison 2000) and complications associated with the systemic effects of SCI can lead to respiratory compromise. Significant delays and complications (sometimes leading to admission to an intensive therapy unit [ITU]) can also arise as a result of inappropriate or poorly informed management.

Immediate care
The first 24 hours following injury constitute 'immediate care'. It is during this time that the majority of complications can occur (Harrison 2000). Decisions made at the scene of the injury can have a profound impact on the outcome for and ongoing management of individual patients, so care pathways are crucial. It has been suggested that spinal injury units (SIUs) may influence the pre‐transfer care of people with SCI by liaising closely with colleagues in general hospital units, and by providing advice and information (Talbot 1979).

Spinal injury units
The concept of the specialist SIU was first conceived in the 1930s and 1940s by Sir Ludwig Guttman in the UK, and by Donald Munro in the USA (Smith 1999). In the UK, the National Spinal Injuries Centre (NSIC), based at Stoke Mandeville Hospital, was opened in 1944. There are currently 12 spinal injury units (SIUs) in the UK and Ireland which provide comprehensive acute, rehabilitation and continuing care facilities and services. In the USA, the Model Regional Spinal Cord Injury Care System programme was established in the early 1970s. At present, 16 centres are funded by the National Institute on Disability and Rehabilitation Research. The goal of these centres is to provide care within 24 to 48 hours for victims of SCI within a defined system (Donovan 1994).

The following minimum standards of SCI care were agreed by all senior medical and paramedical staff at the NSIC in July 2001 (personal communication, Brian Gardner): 1) admission of all newly injured SCI persons in the SCI centre with 24 hours of injury, provided they are fit to make the journey by ambulance; 2) readmission of all SCI persons requiring inpatient hospital treatment into a SCI centre, provided they are fit to make the journey by ambulance; 3) review of SCI persons annually by outreach or a visit to the NSIC; 4) all treatments of accepted value to SCI persons to be available in the SCI centre. The UK Spinal Injuries Association (SIA) and the British Association of Spinal Cord Injury Specialists (BASCIS) both recommend that transfer to a specialist SIU should be made as soon as possible after diagnosis of the spinal cord injury (Aung 1997, Carvell 1989, Carvell 1994, SIA 1997).

In the UK, referral of SCI patients to a local SIU usually takes place within a few weeks or months of injury. Accepted delays in transfer can be due to availability of spinal or ITU beds or physiological status. Transfer may also be delayed due to distance or mode of transport, or where patients present with significant accompanying trauma or respiratory compromise. However, a potentially significant number of people with SCI do not have the opportunity to access this system and are managed in a non‐specialist environment (commonly orthopaedic, neurosurgical or general rehabilitation areas) (Smith 1999).

A systematic review was commissioned by the UK's Health Technology Assessment Programme (Bagnall 2003) on the effectiveness and cost‐effectiveness of acute hospital‐based services for spinal cord injuries. The HTA review aimed to answer five research questions. One of those questions, "Does immediate referral to an SIU result in a better outcome than delayed referral?", is addressed in this review.

Objectives

To answer the question: does immediate referral to a spinal injuries unit (SIU) result in a better outcome than delayed referral?

Methods

Criteria for considering studies for this review

Types of studies

Published and unpublished randomised controlled studies and controlled studies. The question covers referral rather than transfer to SIU, since patients may need to remain in the receiving hospital. The key factor is the advice and influence of the SIU in the management of care.

Types of participants

People of any age with a complete or partial interruption of spinal cord function resulting from trauma.

Types of interventions

Immediate (as defined by relevant studies) versus delayed referral to SIU.

Types of outcome measures

The following outcomes will be included in the review:

  • neurological improvement

  • neurological complications

  • time spent on intensive therapy units (ITUs)

  • time to start of rehabilitation

  • time from injury to completion of rehabilitation

  • psychological and social outcomes (including employment)

  • incidence of secondary complications (including pressure sores, chest infections, urinary infections, septicaemia, upper urinary tract dilation, urinary calculi, renal failure, bladder cancer, contractures of muscle, limitation of range of movement in the paralysed joints, constipation, haemorrhoids, anal fissures, deep vein thrombosis, pulmonary emboli, autonomic dysreflexia, ingrowing toenails, osteoporosis, and fractures of long bones)

  • other adverse events

  • death.

Search methods for identification of studies

A search strategy will be devised to find studies about referral, transfer and discharge of spinal cord injured patients. The strategy will combine 'SCI' search terms with search terms for 'referral, transfer and discharge'. The terms to be used in the search strategy will be identified through discussion with the research team, by scanning background literature, and by browsing through the MEDLINE thesaurus (MeSH).

The following databases will be searched:

  • Allied and Complementary Medicine (AMED)

  • Cochrane Controlled Trials Register (CCTR)

  • Cumulative Index to Nursing and Allied Health Literature (CINAHL)

  • Database of Abstracts of Reviews of Effectiveness (DARE)

  • EMBASE

  • Health Economic Evaluations Databases (HEED)

  • Health Management Information Consortium (HMIC)

  • MEDLINE

  • National Research Register (NRR)

  • NHS Economic Evaluation Database (NHS EED)

  • PsycLIT

  • Cochrane Injuries Group Specialist Register.

In addition the following databases may be searched:

  • Conference Papers Index

  • Science Citation Index.

Searches will also be carried out on the Internet using medical search engines such as OMNI (http://omni.ac.uk/), meta‐search engines such as Copernic (http://www.copernic.com/), and general search engines such as Alta Vista (http://www.altavista.com/) and Google (http://www.google.com/). The following web‐based trial sites will also be searched Clinicaltrials.gov (http://clinicaltrials.gov) and Current Controlled Trials (http://www.controlled‐trials.com). Specialist spinal cord injury and spinal injury related web sites will also be searched, such as the Spinal Injuries Association (http://www.spinal.co.uk/), the British Association of Spinal Cord Injury Specialists (http://www.bascis.pwp.blueyonder.co.uk/) and the National Spinal Cord Injury Association (http://www.spinalcord.org/).

The reference lists of all retrieved studies will also be scanned for additional studies.

Full details of the search strategies are available from the authors.

Data collection and analysis

Two reviewers will independently screen study citations for inclusion. Data will be extracted on to forms developed for different study designs on a Microsoft Access database. One reviewer will extract data and a second reviewer will check the forms for accuracy. Disagreements will be resolved by discussion or, when necessary, with reference to a third reviewer.

The quality of the included studies will be assessed according to criteria set out in NHSCRD's report 4 (Khan 2001). Quality assessment will be carried out by one reviewer, onto forms in an Microsoft Access database, and checked by the second reviewer for accuracy. Disagreements will be resolved by discussion or, when necessary, with reference to a third reviewer. Quality scores will not be assigned to studies, but the results of quality assessment will be discussed in the report.

Where data is sufficiently homogeneous with regard to study design, intervention and outcomes, meta‐analysis will be undertaken, using RevMan software, to produce fixed effects relative risks (RR) and 95% confidence intervals (for dichotomous data) and weighted mean differences (WMD) with 95% confidence intervals (for continuous data). Statistical heterogeneity will be assessed using the chi‐square test with a significance level of 0.10. Forest plots will be presented where appropriate. Where meta‐analysis is not possible, data will be summarised narratively. Prominence will be given to data from studies with the least biased designs and grouped by outcome.

Recommendations for future research will be made, based on the findings of this review.