Diagnostics in the Leg Ulcer Pathway

Study Overview
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Brief Summary
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This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with primary care services, vascular science services, and perform some cost effectiveness modelling on running diagnostic services in primary care and in secondary care settings. A one off questionnaire, designed in Qualtrics, will be sent out to primary care practitioners via social media and email contacts. This will be aimed at establishing their current role and any guidelines they follow with regards to the diagnosis and management of venous leg ulcers in primary care, and to determine their opinion of what this patient pathway should involve. A Delphi consensus will be carried out amongst vascular scientists across the UK to determine current and streamline future practice in diagnostics for patients with venous leg ulcers. The consensus will be achieved when there is ≥ 70% agreement. Cost effectiveness modelling will be carried out on two different scenarios of managing this cohort of patients, one in primary care and one in secondary care settings. Descriptive statistics will be performed on the results.

Detailed Description
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The main objective of this project is to determine the role/position of diagnostic imaging in the patient journey for a patient with active or healed ulceration. To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral. To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK To establish what the minimum diagnostics should be for this cohort of patients including what scans should be performed and can a set criterion be applied to this cohort of patients. To determine the cost effectiveness of implementing this in both primary and secondary care settings.

Official Title
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Estimating & Comparing the Performance, Clinical Effectiveness, and Cost-effectiveness of Current Diagnostic Options for Patients That Present to Primary Care With Suspected Venous Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Other: N/A - Questionnaire based study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary care practitioners working in the UK will be recruited for the primary care questionnaire. Vascular Scientists working in a secondary care hospital in the UK will be recruited for the online delphi consensus. Exclusion Criteria: Participants not meeting the inclusion criteria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary care practitioners<br>A one off questionnaire to be sent to primary care practitioners via qualtrics to determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral. | Other: N/A - Questionnaire based study<br>* Questionnaire based study<br>|
| Vascular Scientists<br>A Delphi Consensus questionnaire will be performed via Qualtrics to determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK | Other: N/A - Questionnaire based study<br>* Questionnaire based study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Care Practitioners | To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral. In order to achieve this, a one of online electronic questionnaire has been designed on Qualtrics. This will be disseminated to a variety of primary care practitioners across the UK. This is a questionnaire with multiple choice and free text boxes for answers, the answers will be analysed qualitatively. | 3 months | 
| Vascular Scientists | To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK. In order to achieve this, a Delphi consensus will be conducted amongst vascular scientists across the UK using online electronic questionnaires have been designed on Qualtrics. It is expected that there will be 3 rounds of questionnaires the Delphi consensus. A consensus will have been achieved when a 70% agreement has been reached on answers to set questions. | 6 months |