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 |