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Crawford F, Chappell FM, Lewsey J, et al. Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model. Southampton (UK): NIHR Journals Library; 2020 Nov. (Health Technology Assessment, No. 24.62.)

Cover of Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model

Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model.

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Chapter 2Overall research objectives

Aim

We aim to undertake an evidence-based evaluation of the clinical effectiveness and cost-effectiveness of foot ulcer risk assessments and structured care interventions for people with diabetes mellitus.

Research questions

  1. What is the estimated clinical effectiveness and cost-effectiveness of a validated CPR as part of structured care to reduce the incidence of DFU?
  2. What is the likely clinical effectiveness and cost-effectiveness of alternative strategies, including monitoring intervals?
  3. Is there worth in undertaking further research, particularly a RCT?

Objectives

Our research objectives are to produce an evidence clinical pathway by:

  • extending (developing) our existing prognostic model into a CPR and conducting its external validation
  • undertaking a survival analysis of the time to ulceration to inform the economic model
  • conducting an overview of SRs to identify the effects and costs of available interventions (simple interventions such as pressure-relieving insoles and complex interventions such as specialist foot care teams)
  • combining the evidence from research questions (i), (ii) and (iii) in a cost-effectiveness decision model framework and analysing alternative clinical and cost-effective regimens at different monitoring intervals
  • carrying out a value-of-information analysis.
Copyright © Queen’s Printer and Controller of HMSO 2020. This work was produced by Crawford et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK564653

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