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Table 2 Secondary outcomes

From: BiCyCLE NMES—neuromuscular electrical stimulation in the perioperative treatment of sarcopenia and myosteatosis in advanced rectal cancer patients: design and methodology of a phase II randomised controlled trial

Domain

Specific measurement

Metric

Method of aggregation

Time point

Lumbar skeletal muscle index (LSMI)

The difference in lumbar skeletal muscle index (LSMI=height / area of skeletal muscle in cm2 at L3) derived from the third lumbar vertebral axial level

Change in LSMI at each time point

CT Scan; SliceOmatic software version 5.0 with ABACS L3 Plug-in automation tool

Pre-surgery

3 to 6 months post-surgery

Visceral adipose tissue (VAT)

Surface area

Visceral adipose tissue area (cm2) derived from the third lumbar vertebral axial level

Change in VAT at each time point

CT Scan; SliceOmatic software version 5.0 with ABACS L3 Plug-in automation tool

Pre-surgery

3 to 6 months post-surgery

Systemic inflammation

C-Reactive Protein and serum albumin

Modified Glasgow Prognostic Score

Ordinal values mGPS=0 mGPS=1 mGPS=2

Preoperatively and 6 months post-surgery

Cellular immune response

Neutrophil count

Lymphocyte count

Neutrophil to lymphocyte ratio (neutrophil/lymphocyte count

Clinically relevant categorical cut off values

NLR<3

NLR>3

Pre-operatively and 6 months post-surgery

Post-operative complications

Any post-operative complication

Clavien-Dindo Classification

Clavien-Dindo Score 1–5

Between 0 and 90 days post-surgery

Length of hospital stay

Inpatient stay post-surgery

Days

Median length of stay

From surgery to hospital discharge

Disease-free survival

Days to reported first recurrence / death / 5 years post-surgery

Days

Kaplan-Meier survival analysis

From date of surgery to 5 years post-surgery

Overall survival

Days to death / 5 years post-surgery

Days

Kaplan-Meier survival analysis

From date of surgery to 5 years post-surgery

Quality of life (General)

EuroQol 5-level EQ-5D5L

Mobility, self-care, usual activities,

Visual analogue scale score 1–100 and score in each of the 5 domains

Change in scores between events

Pre-surgery, 6 and 12 months post-surgery

 

Pain/discomfort and anxiety/depression

   

Quality of life (colorectal specific)

EORTC QLQ - CR29

Function and Symptoms

4 multi-item scales and 19 single items assessing common symptoms and problems in colorectal cancer

Change in score between events

Pre-surgery, 6 and 12 months post-surgery

Function

Berg Balance Scale (BBS)

Berg balance score (0–56)

Change in BBS score

Pre-surgery and 6 months post-surgery

30 s sit to stand

Number of full sit-to stand actions completed in 30 s

Change in number of successful actions

6-min walk test

Distance walked in 6 minutes

Change in metres

Thigh circumference

Thigh circumference, 5cm above the superior pole of the patella

Circumference in cm

Change in thigh circumference between groups

 

Dose response to NMES

Pre- and post-operative mean muscle attenuation (L3) (MMA) and hours of device usage

Change in MMA/time

Linear regression

3–6 months post-surgery

Patient satisfaction

Free text responses and satisfaction scores derived from each domain (see patient satisfaction survey supplementary material).

Qualitative and visual analogue scale 1-10

Qualitative responses

Median score between groups on each domain assessed

8 weeks post-surgery

Bioimpedance analysis

Phase angle = (Xc/R)*180°/π

Cellular resistance (R) and cellular reactance (Xc)

Change in phase angle at each time point

Baseline, day 2 post operatively, day 28 postoperatively (if in hospital), day of discharge, first post-operative follow-up appointment