THERAPY WORKSHEET

Citation: Allsop MJ, Wright-Hughes A, Black K, Hartley S, Fletcher M, Ziegler LE, et al.
Improving the management of pain from advanced cancer in the community: study protocol for a
pragmatic multicentre randomised controlled trial. BMJ Open [Internet]. 2018;8(3):e021965. Available
from: http://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2018-021965

Are the results of this single preventive or therapeutic trial valid?

Was the assignment of patients to Yes. This protocol is for a pragmatic

treatments randomised?
Was the randomisation list concealed?
Was follow-up of patients sufficiently
long and complete?
Were all patients analysed in the groups to
which they were randomised?
multicenter randomised controlled
trial(RCT).Participants will be
randomised on a 1:1 basis to receive
either usual care plus supported self-
management,delivered,within the
oncology clinic and palliative care
services by locally assigned community
palliative care nurses,or usual care.
Participants will be randomised on a 1:1
basis to receive either usual care,using a
computer-generated minimisation
programme,incorporating a random
element,to ensure treatment groups are
well balanced for the following.
Yes.To assess the primary effectiveness
outcome,pain severity,we will fit a
linear mixed-effects regression model
with repeated measures(6 and 12
weeks). The model will contain centre
random effect, and fixed effects for
intervention group, research centre,
baseline score, time, and intervention
group by time interaction. Similarly, a
logistic mixed-effects regression
model will be used to assess the
proportion of participants with ≥30%
reduction in pain severity.
There are no planned interim analyses;
outcome data will be analysed once
only. All analyses will be conducted on
the intent-to-treat population, in which
all participants will be included in the
analysis according to allocation,
regardless of non-compliance with the
intervention. An overall two-sided 5%

Were patients and clinicians kept “blind”
to treatment?
Were the groups treated equally, apart
from the experimental treatment?
significance level will be used for all
statistical endpoint comparisons. Details
of all analysis are
provided in box 1.
No. Following confirmation of
eligibility, written informed
consent and completion of baseline
assessments, participants will be
randomised into the trial by the research
nurse. Randomisation will be performed
centrally via an automated system at the
Clinical Trials Research Unit at the
University of Leeds. Participants
will be randomised on a 1:1 basis to
receive either usual care plus supported
self-management or usual care, using a
computer-generated minimisation
programme, incorporating a random
element, to ensure treatment groups are
well balanced for the following: average
pain at baseline on the BPI (4–6, 7–10)
and recruiting site. The recruiting team
are not involved in subsequent
intervention delivery.
Referral to community palliative care:
Screening of patients with pain from
advanced cancer will be implemented
by optimising entry points to the care
pathway via oncology (or related)
outpatient services and will facilitate the
flow of patients to appropriate pain
support as and when required. Oncology
research nurses will refer trial
participants to the local community
palliative care team at which point the
locally assigned palliative are nurse will
endeavour to arrange an initial
visit/appointment with participant
within 1 week of randomisation.
Appointment into palliative care: This
will take place by a locally assigned
community palliative care nurse.
Routine practice will be followed,
including an assessment of the
participants’ other palliative care needs.
For those participants allocated to

Were the groups similar at the start of the
trial?
receive usual care and supported self-
management, the nurse will be trained in
the trial interventions and will introduce
and deliver the trial interventions
described below, alongside their usual
care.
Yes because Inclusion criteria
1. Male or female aged ≥16 years
2. Diagnosis of advanced incurable
cancer (locally advanced or metastatic)
Experiencing cancer-related pain
(tumour
or treatment related) with a pain score
of ≥4 on the ‘average pain’ item of the
Brief Pain Inventory
3. Has the potential to benefit from pain
management
4. Expected prognosis of ≥12 weeks
5. Living at home
6. The patient is living in the local
catchment area for a participating
hospice
7. The patient is able and willing to
provide written informed consent

Are the valid results of this randomised trial important?

SAMPLE CALCULATIONS
Occurrence of diabetic Relative risk Absolute risk Number
neuropathy at 5 years among reduction reduction needed to
insulin-dependent diabetics in (RRR) (ARR) treat (NNT)
the DCCT trial
Usual insulin Intensive insulin
regimen regimen CER – EER CER-EER 1/ARR
control event experimental CER
rate (CER) event rate (EER)
2.8% 9.6% - 2.8% 9.6% - 2.8% 1/6.8%
9.6% = 6.8% = 15 patients
= 71%
95% CI * 4.4% to 9.2% 11 to 23

* 95% confidence interval (CI) on an NNT = 1/(limits on the CI of its ARR) =

 CER  (1  CER )   EER  (1  EER )   0.96  0.904   0.028  0.972 
 1.96       1.96     2.4%
 # ofControlPts   # ofExperPts   730   711 
YOUR CALCULATIONS
Relative risk Absolute risk Number
reduction reduction needed to
(RRR) (ARR) treat (NNT)
CER EER CER – EER CER-EER 1/ARR
CER

95% CI 

Can you apply this valid, important evidence about therapy in caring for your
patient?
Do these results apply to your patient?
Is your patient so different from those in
the study that its results cannot apply?
Is the treatment feasible in your setting?
What are your patient’s potential benefits and harms from the therapy?
Method I: f Risk of the outcome in your patient,
relative to patients in the trial.
Expressed as a decimal: ______
NNT/f = ______ / ______ = ______
(NNT for patients like yours)
Method II: 1/(PEER x RRR) Your patient’s expected event rate if they
received the control treatment (PEER)
= ______
1/(PEERxRRR) = 1/________ = ______
(NNT for patients like yours)
Are your patient’s values and preferences satisfied by the regimen and its
consequences?
Do your patient and you have a clear
assessment of their values and
preferences?
Are they met by this regimen and its
consequences?

Additional notes: