Getting out of the House Study Statistical analysis plan
11. FINAL REPORT TABLES AND FIGURES COMMENT
Specify layout, for example by presenting dummy tables. The following rules may be adopted when creating the summary tables:
Number of decimal places (DP):
l for minimum and maximum the number of DPs will be the same as the raw data l for mean, median and SD the number of DPs will be one more than the raw data l percentages–Round up to the nearest whole number
l p-values–3 decimal points will be presented l no more than 4 significant numbers will be used.
Data presentation:
l Treatment group will be in columns with the visits in rows.
l Column headers in mixed case, with‘(n=nn)’below treatments to denote the denominator. l Decimal places will be aligned.
l n(%) as a separate column rather than included in brackets for each element of the table. l Categories (i.e. in column 1) in sentence case, in the order on the CRF.
l Ordering of statistics N, Missing, Mean, SD, CV%, Minimum, Median and Maximum. Geometric Means inserted between Mean and SD for pharmacokinetics.
11.1. Subject characteristics and background summaries
TABLE 1 Baseline characteristics
Variable Parameter
Treatment arm
A B
Total N
Age at inclusion Mean (SD)
Median (IQR) Minimum, maximum Sex Female n(%) Male Ethnicity White n(%) Black–Caribbean Black–African Black–Other Pakistani Indian Bangladeshi Chinese Mixed Not given Other
Residential status Lives alone n(%)
Lives with others Living in care home
Time since stroke Mean (SD)
Median (IQR)
11.2. Study quality summaries
TABLE 1 Baseline characteristics (continued)
Variable Parameter
Treatment arm
A B
Social functioning score Mean (SD) Median (IQR)
Minimum, maximum
NEADL1score Mean (SD)
Median (IQR) Minimum, maximum
Rivermead Mobility Index score Mean (SD) Median (IQR)
Minimum, maximum Satisfaction with outdoor mobility Yes n(%)
No
General Health Questionnaire (Participant) Mean (SD) Median (IQR)
Minimum, maximum
1 = Nottingham Extended Activities of Daily Living Scale (Functional ability).
TABLE 2 Inclusion/exclusion criteria
Inclusion criteria Yes No
Is the participant aged 18 years or older?
At least 6 weeks but no longer than 5 years since stroke?
Wishing to get out of the house more often? Has the participant given written informed consent?
Exclusion criteria Yes No
Not able to comply with the requirements of the protocol and therapy programme, in the opinion of the assessor?
Still in post-stroke intermediate care or active rehabilitation? Previous enrolment in this study?
TABLE 3 Withdrawals
Withdrawals A (n= . . .) B (n= . . .)
Total (n= . . .)
1. Participant withdrew from the study 2. Participant lost to follow-up
3. Participant experienced an adverse event 4. Investigator withdrew participant
5. Other (specify)
*all values aren(%)’s unless specified.
TABLE 4 Compliance of diary calendars
Compliance of the diary calendars Total overall (N= . . .)
Total excluding any withdrawals (N= . . .)
n(%) returned no calendars
n(%) of participants who returned 1 month of travel calendar
n(%) of participants who returned 2 months of travel calendar
n(%) of participants who returned 3 months of travel calendar
n(%) of participants who returned 4 months of travel calendar
n(%) of participants who returned 5 months of travel calendar
n(%) of participants who returned 6 months of travel calendar
n(%) of participants who returned 7 months of travel calendar
n(%) of participants who returned 8 months of travel calendar
n(%) of participants who returned 9 months of travel calendar
n(%) of participants who returned 10 months of travel calendar
n(%) of participants who returned 11 months of travel calendar
n(%) of participants who returned 12 months of travel calendar
TABLE 5 Compliance of the questionnaires
Compliance of the questionnaires Total (N= . . .)
n(%) of the 6 months questionnaires returned
n(%) of the participants who completed the SF361questionnaire in full
n(%) of the participants who completed NEADL2questionnaire in full
n(%) of the participants who completed RMI3questionnaire in full
n(%) who answered the SWOM4question
n(%) of the participants who completed the GHQ-125questionnaire in full
n(%) of the 12 months questionnaires returned
n(%) of the participants who completed the SF361questionnaire in full
n(%) of the participants who completed NEADL2questionnaire in full
n(%) of the participants who completed RMI3questionnaire in full
n(%) who answered the SWOM4question
n(%) of the participants who completed the GHQ-125questionnaire in full
*all values aren(%)s unless specified.
1 = Questions 6 and 10 of the SF36 questionnaire. 2 = Nottingham Extended Activities of Daily Living Scale. 3 = Rivermead Mobility Index.
4 = Satisfaction with outdoor mobility. 5 = General Health questionnaire–12.
TABLE 6 Extent of study intervention
Extent of study intervention Total (N= . . .)
1. n(%) of participants received 1 therapy session 2. n(%) of participants received 2 therapy sessions
3. n(%) of participants received 3 therapy sessions 4. n(%) of participants received 4 therapy sessions
5. n(%) of participants received 5 therapy sessions 6. n(%) of participants received 6 therapy sessions
7. n(%) of participants received 7 therapy sessions 8. n(%) of participants received 8 therapy sessions
9. n(%) of participants received 9 therapy sessions
10. n(%) of participants received 10 therapy sessions
11. n(%) of participants received 11 therapy sessions
TABLE 7 Number of therapists providing the intervention in each centre
Centre No. of therapists providing the intervention
Nottingham City PCT
Nottinghamshire County Teaching PCT
Lincolnshire PCT Gateshead PCT
NHS Lanarkshire North Somerset PCT
Wolverhampton PCT
East Kent Community Services
Tower Hamlets Southend
Aberdeen Norwich
Cwm Taf Cardiff & Vale
Bristol PCT
(Min; Max) No. of therapists seen by the participants
TABLE 8 List of protocol deviations
11.3. Primary outcome results at 6 months
11.4. Secondary outcomes results at 6 months
TABLE 10 Nottingham Extended Activities of Daily Living (NEADL) Scale
Burn-in period = xxxx No. of observation = xxx Chain = xxxx Estimation algorithm = MCMC Thinning = xxxx
Deviance = xxxx
Bayesian deviance = xxxx
NEADL score Mean Standard error p-value 95% credible interval
Treatment A (baseline) – – – –
Treatment B XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX Level 2: Therapist XXX XXX XXX to XXX
Level 1: Participants XXX XXX XXX to XXX TABLE 9 Primary outcome table
Social Functioning Score Mean Standard error p-value 95% credible interval
Treatment A (baseline) – – – –
Treatment B XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX Level 2: Therapist XXX XXX XXX to XXX
TABLE 12 Number of travel journeys
Burn-in period = xxxx No. of observation = xxx Chain = xxxx Estimation algorithm = MCMC Thinning = xxxx
Deviance = xxxx
Bayesian deviance = xxxx
Travel journeys Mean Standard error p-value 95% credible interval
Treatment B – – – –
XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX Level 2: Therapist XXX XXX XXX to XXX
Level 1: Participants XXX XXX XXX to XXX TABLE 11 Rivermead Mobility Index (RMI) Scale
Burn-in period = xxxx No. of observation = xxx Chain = xxxx Estimation algorithm = MCMC Thinning = xxxx
Deviance = xxxx
Bayesian deviance = xxxx
RMI score Mean Standard error p-value 95% credible interval
Treatment A (baseline) – – – –
Treatment B XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX
Level 2: Therapist XXX XXX XXX to XXX Level 1: Participants XXX XXX XXX to XXX
11.5. Primary endpoint at 12 months
TABLE 13 Satisfaction with outdoor mobility
Burn-in period = xxxx No. of observation = xxx Chain = xxxx Estimation algorithm = MCMC Thinning = xxxx
Deviance = xxxx
Bayesian deviance = xxxx
Satisfaction with outdoor mobility (yes/no) Coef. Standard error p-value 95% credible interval
Treatment B – – – –
XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX
Level 2: Therapist XXX XXX XXX to XXX Level 1: Participants XXX XXX XXX to XXX
TABLE 14 GHQ-12 participant
Burn-in period = xxxx No. of observation = xxx Chain = xxxx Estimation algorithm = MCMC Thinning = xxxx
Deviance = xxxx
Bayesian deviance = xxxx
GHQ-12 participant score Mean Standard error p-value 95% credible interval
Treatment A (baseline) – – – –
Treatment B XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX Level 2: Therapist XXX XXX XXX to XXX Level 1: Participants XXX XXX XXX to XXX
This is the same analysis as 6 months, repeated for data at 12 months. 11.6. Secondary endpoints at 12 months
This is the same analysis as 6 months, repeated for data at 12 months.
TABLE 15 GHQ-12 carer
Burn-in period = xxxx No. of observation = xxx Chain = xxxx Estimation algorithm = MCMC Thinning = xxxx
Deviance = xxxx
Bayesian deviance = xxxx
GHQ-12 carer score Mean Standard error p-value 95% credible interval
Treatment A (baseline) – – – –
Treatment B XXX XXX XXX XXX to XXX
Age XXX XXX XXX XXX to XXX
Constant XXX XXX XXX XXX to XXX
Random-effects parameters Mean Standard error 95% credible interval
Level 3: Centre XXX XXX XXX to XXX
Level 2: Therapist XXX XXX XXX to XXX Level 1: Participants XXX XXX XXX to XXX
11.7. Exploratory/other analysis results
TABLE 16 Summary for NEADL scale categories at baseline
Category Treatment arm A B Mobility n Mean (SD) Median (IQR) Min. to max. Kitchen n Mean (SD) Median (IQR) Min. to max. Domestic n Mean (SD) Median (IQR) Min. to max. Leisure n Mean (SD) Median (IQR) Min. to max
TABLE 17 Summary for NEADL scale categories at 6 months Category Treatment arm A B Mobility n Mean (SD) Median (IQR) Min. to max. Kitchen n Mean (SD) Median (IQR) Min. to max. Domestic n Mean (SD) Median (IQR) Min. to max. Leisure n Mean (SD) Median (IQR) Min. to max.
TABLE 18 Summary for NEADL scale categories at 12 months Category Treatment arm A B Mobility n Mean (SD) Median (IQR) Min. to max Kitchen n Mean (SD) Median (IQR) Min. to max. Domestic n Mean (SD) Median (IQR) Min. to max. Leisure n Mean (SD) Median (IQR) Min. to max.
TABLE 19 Summary of travel journeys
Travel journeys Treatment arm A B Total journeys Mean (SD) Median (IQR) Min. to max.
TABLE 20 Summary of type of intervention received by the participants in the treatment group
Intervention type n(%) Participants
No. of sessions
Mean (SD) Median (IQR) Min–Max
Mobility Confidence Information Goal Setting Referral Other Rehab Adaptive Equipment
TABLE 21 Summary of type of goals set to participants in the treatment group
Goal type* n(%) Participants
Goal 1
Goal 2 . . .
GoalN
TABLE 22 Assessment of unblinding of research assistants (RA)
Unblinding
Treatment arm
Total
A B
11.8. Safety results