Table 1.
Data collection
| Data collection tool | Time point of study | When collected/given to patient | By who | Purpose |
|---|---|---|---|---|
| Informed consent form |
Recruitment |
In clinic, face to face |
Neurology or respiratory consultant |
Ensure participants have been consented appropriately |
| Screening and eligibility assessment form |
Recruitment/Screening |
In clinic |
Neurology or respiratory consultant or research nurse |
Ensure protocol violations or deviations are avoided. Include ECG, blood gases, blood test, FVC and phrenic nerve evaluation tests |
| ALSFRSr |
Screening |
As above |
As above |
Allows minimisation on bulbar function |
| Survival |
1 week, 2, 3, 6, 9, 12 months, then finally at last follow up for last patient |
In clinic, telephone |
Research nurse |
Primary outcome measure |
| *EQ5D questionnaire (patient and carer) |
Screening, 2, 3, 6, 9 and 12 months |
In clinic or over the phone |
Neurology or respiratory consultant or research nurse |
QALYs, secondary outcome measure |
| SF36 |
Screening, 2, 3, 6 and 12 months |
As above |
As above |
Generic quality of life, secondary outcome measure |
| Sleep Apnoea Quality of Life (SAQLI) |
Screening, 2, 3, 6 and 12 months |
As above |
As above |
Respiratory specific quality of life, secondary outcome measure |
| *Caregiver Burden Inventory questionnaire |
Screening, 2, 3, 6 and 12 months |
As above |
As above |
Secondary outcome measure |
| Side effects/ adverse event/concomitant medications and devices forms |
All time points as required |
As above |
As above |
AE/SAEs |
| Healthcare resource use |
2, 3, 6, 9 and 12 months |
As above |
As above |
Economic, secondary outcome measure |
| Patient Diary incorporating: |
1 week, 2, 3, 6, 9 and 12 months |
In clinic, at hospital or at home |
Neurology or respiratory consultant and Patient and Carer |
Main outcome Record DP and NIV use |
| * NIV use | ||||
| * DP use and | ||||
| * DP Parameters setting | ||||
| NIV use |
Screening |
As above |
As above |
Main outcome |
| Medical history and examination on CRF |
Screening and 12 months |
In clinic |
Neurology or respiratory consultant |
Eligibility for trial, safety |
| Surgery evaluation form/ pre op safety check |
Screening, Surgery and 1 week |
In clinic or hospital |
Neurology or respiratory consultant or Surgeon |
Safety and eligibility for surgery |
| Surgical implantation/ intra operative form |
Surgery |
In hospital |
Neurology consultant or Surgeon |
Testing DP device in situ |
| Discharge evaluation form |
Surgery |
In hospital |
Neurology or respiratory consultant or surgeon |
Demonstrate patient and carer competent to use and care for DP device |
| DP parameters setting |
Surgery |
Clinic |
Neurology or respiratory consultant |
Evaluate the DP device, allow optimal use of device |
| *Qualitative interview (n = 12, Patient and carer) | 1 and 6 months post implantation | Participants place of choice | Qualitative fellow | Sub study outcome |