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Study objective, hypothesis and question?
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Study Objective: To determine whether there is an excess of cognitive impairment in patients with T2DM and foot ulceration.
Hypothesis Question: Whether DFUs in people with T2DM is associated with greater cognitive impairment, compared with T2DM without DFU.
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Rationale and relevance of the question?
(Why was the study done?)
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Patients with a Diabetic Foot Ulcer often do not complete what is required to manage their DFU. Is there some Cognitive Impairment in patients with a Diabetic Foot Ulcer that impedes ability to carry out what’s required to manage DFU?
Should tools be used to assess/explore cognitive impairment to improve patient education and patient outcomes?
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Relevance of this topic/question to FH Podiatrists?
(Is it urgent or essential reading for a podiatrist working in an acute hospital?
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Highly relevant across all HRFS.
Patients provided with instructions and information, yet are unable to complete instructions.
Essential reading for podiatrists working in HRFS/with patients presenting with DFUs.
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What methodological approach (design, analysis, etc.) has been used?
(RCT, Case control, case study series, meta analysis etc.)
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Methodological approach used: observational cross-sectional study which was the most pragmatic design based on the resources available.
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What were the results of the study? (What did the investigators find?)
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No difference found between the two groups assessed regarding cognitive scores. The study did not show an excess of cognitive impairment in patients with T2DM and DFU compared with patients with T2DM and no DFU.
50% of participants across both groups had mild cognitive impairment.
Prior studies conducted and compared results between population with T2DM and DFUs vs no diabetes – Found disparity between co-morbidities, potentially influencing causation and pathway for cognitive impairment.
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Strengths & weaknesses of this study? Are the results valid? Look at study design, appropriateness of the method(s), population and sample size, appropriate study conduct, data gathering, subject follow‐up, influences of bias, methods of analysis, discussion, currentness and comprehensiveness of the listed references
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Strengths
- - The amount of data collected was substantial.
Weakness
- - Cross-sectional design means it is not possible to draw conclusions regarding causality.
- - Logistical constrains meant that 111 participants were recruited instead of 200 participants (100 per group) as initially planned which may have contributed to a type 2 error.
- - Recruitment from a hospital outpatient clinic may limit the generalisability of findings.
- - Assessment of foot self-care relied on self-reporting allowing room for the possibility of recall and social desirability bias.
- - Patients better matched with comorbidities in this study, and have common pathways regarding diabetes.
- - No longitudinal data was assessed. The prognostic impact of any impact of any differences between cohorts could not be investigated.
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Do the conclusions follow logically from the design and results?
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Yes
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How do the results relate to current practice and how might they influence future practice? (What does the answer mean anyway? So what? Who cares?)
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Future research is needed to establish whether cognitive impairment impacts DFU healing/LEA outcomes.
Detailed assessment of self-care behaviour currently under review, not yet published.
Non-adherence and adverse DFU outcomes may potentially be driven by other factors such as behavioural aspects, personality constructs, social disadvantage, education aspects, work commitments, family commitments, health literacy impacting self-care behaviour.
Clinicians need to adjust how patient education is delivered to this vulnerable cohort of patients who have challenges regarding memory and retention – Change delivery of education to be succinct and clear, being mindful of prevalence in patient cohort.
Improved access to Health Psychology within a High-Risk Foot Service is required to improve outcomes for patients.
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