Page 21 -
P. 21
surgeon’s treatment preference for IPD or decompression surgery will be assessed on a 5-point scale ranging from “strong preference for IPD” to “strong preference for decompression surgery”.
Outcome assessment
The validated outcome parameters described below will be used in this study and assessed by means of questionnaires. Follow-up examinations by the research nurse will take place at 2, 4, 8 weeks, 3, 6, 12, 24 and 60 months after randomization (see table 3: flowchart). Patients will be neurologically examined (at 8 weeks, 6, 12, 24 and 60 months) and the main questionnaires will be filled out at home with a request to complete and return them. The outpatient control by the neurosurgeon will be at 8 weeks and more often if necessary (see table 3: flowchart)
Table 3. Flowchart
In-patient
Out-patient x
Demography & diagnosis x
Basic physical examination x
Neurological examination x
Provide study information x
Obtain informed consent x
X-ray
Randomisation
ZCQ x
MRDQ x
Shuttle Walking Test x
SF-36 x
McGill Pain Questionnaire x
VAS for legs and back x
Perceived Recovery
Patient Global Impression of change
x
x x
xxxxxx x xxxx
x
EuroQol & VAS Quality of Life x
Patient diary
Review MRI x
Complications xxxx xxxx
Re-operation x
x xxxx
xx x x
x x x x
x x x x x x
Felix: Design and protocol
Obtained patients’ information
V1
V2
V3
V4
V5
V6a
V7
V8
V9
V10
xxxxxxxx x xxxxxx xxxxxx xxxxxxx
x xx x x x
x x x x x x x x
x x x x x x x x x x x x
A, questionnaires will be sent per mail with request to complete and return them; V1, visit 1 - Intake; V2, Visit 2 - surgery; V3, Visit 3 - Follow-up 2 weeks; V4, Visit 4 - Follow-up 4 weeks; V5, Visit 5 - Follow-up 8 weeks; V6, Visit 6 Follow-up 3 months; V7, Visit 7 – Follow-up 6 months; V8, Visit 8 - Follow-up 12 months; V9, Visit 9 - Follow-up 24 months; V10, Visit 10 - Follow-up 60 months
59
4
