Definitions
Trial
Trial 1 has follow-up at pre-op (FU.tr.1) and baseline 6 months
earlier (patients from LAPPRO, QoliCOL, QoliRECT enrolled).
Trial 2 has follow-up at 3 months (FU.tr.2) and baseline at pre-op
(patients from LAPPRO enrolled)
Trial 3 has follow-up at 12 months (FU.tr.3) and baseline at pre-op
(patients from LAPPRO, QoliCOL, QoliRECT enrolled)
Trial 4 has follow-up at 24 months (FU.tr.4) and baseline at 12
months (patients from LAPPRO, QoliRECT enrolled).
Eligibility criteria and analysis sets
Patients are eligible for inclusion if they have not picked up
prescription 12 months before baseline. Patients are analysed as
randomized using an intention-to-treat analysis if they have returned
the baseline questionnaire and follow-up questionnaire.
Data fix
Patients with no expedition should get their expedition date
‘1970-01-01’. If there is an empty line for a patient, then it is
assumed he/she did not get BB (we code it as they picked up the
prescription 1970-01-01 ).
Study flow chart and demographics and patient characteristics
LPR: 3705 patients; QL: 1677 patients, QR: 852 patients. (total =
6234 patients)
Trial 3: 4020 patients returned questionnaire both at baseline and
follow-up
Trial 4: 3219 patients returned questionnaire both at baseline and
follow-up
Among those included, which will be included in the respective
group?
Among those included:
Trial3: 59 Active, 3961 Control
Trial4: 87 Active, 3219 Control
LAPPRO: 3705 patients; QoliCOL: 1677 patients, QoliRECT: 852
patients. (total = 6234 patients)
Statistical model
Endpoints modelled using ordinal regression assuming proportional
odds. Weakly regularizing priors (\(\beta \sim
N(0, 1)\)) on the logit scale were used for treatment factor
(Active vs Control). Baseline value of endpoints was included, with a
monotone effect using a Dirichlet distribution.
Variables adjusted för are: - Binge drinking (Drinking at least 6
glass on the same occassion, YES or NO) - Age - Mental health status
(History of psychiatric health issues of prescription of
anti-depressant)
Imputations using MICE (5 imputed data sets).
Study results
Analyse and present results for trial 1 and 2.
Primary:
How often in the last month have there been negative thoughts about
your cancer suddenly and by itself?
Co-primary:
How severe has the sudden negative intrusive thoughts been?
Secondary 1:
Depressed mood
Secondary 2:
How would you like to describe your quality of life in the last
month?
Secondary 3:
Have you experienced periods of intense anxiety, worry or
panic
Secondary 4:
Have you woken up at any time during the night with worry, anxiety
or an unpleasant feeling the last month?
Main analysis of endpoints
Odds ratio describes the relative (Active vs Control) of more worse
outcomes. That is large values (>1) of odds ratio means that patients
on Active are worse off compared to Control. Small values (<1) of
odds ratio means that patients on Active are better off compared to
Control.
Patients assigned to Active group had higher tendency to poor QoL (OR
1.90 and 1.60 for trial 1 and 2, respectively. Patients assigned to
Active had more periods of intense axiety, worry and panic in trial 2
(OR=2.5)
Primary:
How often in the last month have there been negative thoughts
about your cancer suddenly and by itself?
Large value of odds ratio favors Control. Posterior probability that
odds ratio > 1 is 23%.
Co-primary:
How severe has the sudden negative intrusive thoughts
been?
Secondary 1:
Depressed mood
Secondary 2:
How would you like to describe your quality of life in the last
month?
Secondary 3:
Have you experienced periods of intense anxiety, worry or
panic
Secondary 4:
Have you woken up at any time during the night with worry,
anxiety or an unpleasant feeling the last month?
Supplementary material
Supportive sensitivity analyses
Unadjusted and frequentist analysis
Unadjusted analysis is model with only treatment factor (Active or
Control) is in the model (complete cases, no imputations).
Frequentist analysis use same adjustment variables as main analysis
as well as pooled across the 5 imputed data sets
Prevalent users analysis
Patient assigned to Active if picked up at least one prescription any
time before follow-up. Patient assigned to Control if picked up no
prescription any time before follow-up.
Unadjusted analysis.
Trial 3
t1
##
## Control Active
## 4782 1252
Trial 4
t2
##
## Control Active
## 3594 825
MCMC diagnostics
Primary:
How often in the last month have there been negative thoughts
about your cancer suddenly and by itself?
Co-primary:
How severe has the sudden negative intrusive thoughts
been?
Secondary 1:
Depressed mood
Secondary 2:
How would you like to describe your quality of life in the last
month?
Secondary 3:
Have you experienced periods of intense anxiety, worry or
panic
Secondary 4:
Have you woken up at any time during the night with worry,
anxiety or an unpleasant feeling the last month?
Missing data patterns
Trial 3
Trial 4
