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Table 2 Feasibility, clinical efficacy, patient reported and health and social care usage

From: A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM)

Feasibility outcomes

Clinical efficacy outcomes

Collected – all study visits

Patient reported outcomes

Collected – baseline, 3 monthly until remission, then at 1 and 6-months post remission

The proportion of patients who meet the eligibility criteria

Time in cast/off-loading device

Health related quality of life measured:

• SF-12 [18]

• EQ-5D-5L [19], analysed using the crosswalk methodology [20]

The number of eligible participants recruited

Number of new ulcerations on the index foot

HADS [21]

The number of participants in which an alternative diagnosis is made during the active phase of the study

Number of new ulcerations on the index or contralateral foot

VAS

The proportion of participants that withdraw or are lost to follow up. The term ‘withdrawal’ encompasses two potential scenarios: withdrawal due to loss of consent or withdrawal due to death

Number of new infections on the index or contralateral foot

Data on health and social care usage- Patient Diary

• Change in employment

• Frequency and the amount of time participants received help with personal and household tasks

• Number of all healthcare appointments

• Number and severity of falls (Hopkins Fall Grading System) [22]

Statistical parameters of the key outcome measures to inform a sample size calculation for a definitive study

Number of minor and major amputations on the index foot or contralateral foot at the end of the follow up phase of the study

 

Safety of the intervention (MRI).

The number of participants in each arm requiring further intervention for Charcot (e.g., further immobilisation) within 6 months of remission

 

Data completeness and adherence to study procedures

  

Participant acceptability of MRI - the number of MRIs declined or not attended by participants

  
  1. Abbreviations: EQ-5D-5L Euroqol 5D, HADS Hospital Anxiety and Depression Scale, SF-12 Medical Outcomes Short-Form Health Questionnaire, VAS Visual analogue scale