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 (nā€‰=ā€‰12, Patient and carer) 1 and 6 months post implantation Participants place of choice Qualitative fellow Sub study outcome

McDermott et al.

McDermott et al. BMC Neurology 2012 12:74   doi:10.1186/1471-2377-12-74

Open Data