OPEN

A Multicentre Prospective Service Evaluation to establish the feasibility of unified lower limb injury cohort data collection utilising an open fracture injury database pilot.

Background

A study by the National Confidential Enquiry into Patients Outcomes and Death (NCEPOD) in 2007 showed a large proportion of trauma patients received treatment at a lower standard than was expected [1]. In 2012, this NCEPOD finding helped drive the division of hospitals into major trauma centres (MTC) and trauma units (TU) with the inception of regional trauma networks. This change centralised sub-specialties in order to manage patients with the most severe injuries, in particular orthopaedic and plastic surgery teams within orthoplastic centres. This combination of early triage and multi-specialist input has helped to improve the level of care provided to patients with the most severe of injuries [2].

Originally published in 2008, BOA Standards for Trauma and Orthopaedics (BOAST) have provided short documents offering guidance in the management of both trauma and elective care of orthopaedic patients. The BOAST guideline for open fractures, in collaboration with the Orthopaedic trauma society (OTS), British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) and the British Limb Reconstruction Society (BLRS) was most recently updated in December 2017. This provides an easy access guide to the standards of care expected for patients presenting with open fractures [3]. As present there is no national audit of these standards.

Open fractures can present to any unit prior to triage and BOAST dictates that patients with open fractures of long bones, hind foot or mid-foot should be taken directly or transferred to a specialist centre that can provide Orthoplastic care.^[3] Despite national guidance from NICE, BOAST Guidelines and the inception of trauma networks, there is no data available for this key patient group other than Trauma Audit and Research Network (TARN) publications. These publications are limited by data completeness and only have grade III open tibia fractures represented up until recently.

The OPEN Study (Open-Fracture Patient Evaluation Nationwide) is a multicentre prospective service evaluation that will evaluate the epidemiology, patient characteristics and management of patients that have sustained any open fracture (excluding phalanges). A secondary aim will investigate the viability in the use of an electronic follow up system in recording patient post-surgical outcome scores.

Aims and Objectives

• To describe the incidence of different types of open fractures and how these injuries are managed within different units.
• To describe the patient characteristics of the cohort of patient who sustain an open fracture.
• To obtain basic information about the clinical outcomes following open fractures with regards to length of stay, complications and transfer to specialist units.
• To audit practice against that of current BOAST open fracture guidelines.

Project design

The study will be run as a multicentre prospective service evaluation. The design fulfils the criteria for service evaluation as there is no patient randomisation, no changes to current care, are we are not making generalisations about the delivery of care but reporting actual care at the contributing sites. This is in line with the HRA decision algorithm for defining ‘Is my project research?’. Participants within the evaluation will be patients that presented to hospital with an open fracture (excluding phalanges) between 1st June 2021 and 1st October 2021. Only anonymised patient data will be collected with minimal patient identifiers (NHS number, age & gender) which should satisfy the requirements of information governance teams at each participating site.

Screening and Consent

All open fractures (excluding phalanges) that present to the orthopaedic services of each participating hospital between 1st June 2021 and 1st October 2021 will be identified. Means of identification will vary at each site but may include theatre records, electronic trauma databases, personal surgeon records, hospital coding databases etc.). For each identified patient data will be recorded on three separate areas of their care:

• Patient, injury and fracture characteristics
• Treatment / surgical management
• Post-operative care
• Consent for follow-up patient outcome questionnaire.

A data input tool will be created within REDCap data collection system to facilitate and standardise data input. Information will be collected directly from patients, from routine data stored in the patient records, theatre records, operation notes, discharge letters and routine trust data collection systems.

Pre-operative data collection

The evaluation will collect baseline information about patient demographics, the presenting fracture (universal AO classification) and treatment delivered (timing of surgery, implants used, soft tissue coverage etc). This data will inform future service recommendations as well as future research needs. By collecting data about the type of treatment offered alongside the routinely collected outcome data, we can look for associated between the different approaches to management used within the different sub-types of fractures presenting to hospital upon outcome which may also help to guide future research in this area.

Post-operative follow-up

Consent for post-operative follow-up will need to be gained to enable to electronic distribution of a patient evaluation questionnaire at 3, 6 and 12 months.

Data capture

All collected data will be entered into using the REDCap data collection system.

Project Population

This evaluation will aim to collect data from all open fractures (excluding phalanges) presenting to secondary care between June 1st 2021 and October 1st 2021 based on the following inclusion / exclusion criteria.

Inclusion criteria

• All age ranges (those under the age of 18 will require consent to be gained by parent/guardian for follow up questionnaire).
• All new open fractures related excluding phalanges.

Exclusion criteria

• Open fractures of phalanges.

Project intervention

There is no specific study intervention. All patients will receive standard care as per their treating surgeons usual practice. There will therefore be no change in care for any study participants.

Project data

Pre-operative data collection

Baseline Demographics

• NHS number (to aid patient identification if transferred)
• Age
• Employment status
• Gender
• Smoking
• Diabetes status
• Co-morbidity index and frailty score
• Patient transfer
• Date/time of antibiotic administration

Fracture Characteristics

• Date and time of fracture
• Mechanism of fracture
• Fracture classification (AO Universal classification and OTS open fracture classification)
• Documented plan by both orthopaedic and plastic surgery teams

Surgical Characteristics

• Date/time of Surgery
• Grade of lead surgeon
• Presence of plastic surgeon and grade
• Soft tissue coverage
• Stabilisation method
• Operative findings and information

Post-operative data collection

• Length of stay (primary and subsequent admissions)
• Antibiotic continuation
• Transfer to specialist unit
• Weight bearing status

Data Management

Data collected by staff at each site will be entered on to REDCap electronic data collection system and held on the study database. The REDCap system is housed on secure servers at the South Tees Hospitals NHS Foundation Trust.

Once the project team have confirmation of the sites willingness to participate and a copy of their local service evaluation approval along with the REDCap user registration and data sharing agreement, then the site will be provided with a login for REDCap.

The identifiable information recorded via REDCap are the NHS number, age and gender. The NHS numbers are recorded on the REDCap data capture system only for the purpose that hospital sites can identify the patient record on the electronic data capture system and will allow site staff to come back to the records to make amendments before submitting each record and also easy identification of patients transferred to specialist units following initial management. South Tees Hospitals NHS Foundation Trust will not use the hospital numbers in any reports produced from the multicentre service evaluation.

Quality checks will be implemented and built into database to ensure critical data points entered into the electronic system is complete and valid. Once all data has been collected, it will be downloaded into an Excel spreadsheet for later transfer into a statistical package such as SPSS v24, for analysis. At the end of the study, when all analysis of the data has been completed, the study data will be archived as per the sponsor’s archiving SOP.

Sample considerations and analysis

Sampling

In this service evaluation we will aim to involve as many sites as possible and obtain a geographical spread so that the management of all open fractures is captured. We will aim to involve a minimum of 40 sites but will approach as many as are interested in participating. We anticipate that between 5 and 40 patients per site will be eligible for inclusion during the period of 1st June 2021 to 1st October 2021. The data collected from the participating centres will provide information on the number and distribution of these injuries in the UK. Approaches to sites will be co-ordinated via BOTA with the anticipation that OPEN will be run through regional trainee research groups.

Analysis plan

All data and outcomes will be reported descriptively with continuous outcomes reported as mean (standard deviation) or median (interquartile range). Binary or categorical data will be reported as counts, proportions and percentages.

Outcome measures (e.g. Length of stay, mortality, discharge destination) will be analysed using regression modelling with adjustment for baseline variables (fracture type, fracture treatment, patient demographics). Between group comparisons will be reported using confidence intervals and p-values.

Project duration

We aim to start the project on the 1st June 2021. We are aiming for a completed dataset returned from each study site via the REDCap data entry system within 4 weeks of data collection close (30th October 2021) at each participating site. We aim to start data analysis by the 1st October 2021 and have completed analysis by 31st October 2021.