Table 1 Data collection

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