Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS).

0.36 MB·English

by  Carnes, Dawn

Open Access Protocol
Effectiveness and cost-effectiveness of a
novel, group self-management course
for adults with chronic musculoskeletal
pain: study protocol for a multicentre,
randomised controlled trial (COPERS)
Dawn Carnes,1 Stephanie JC Taylor,1 Kate Homer,1 Sandra Eldridge,2
Stephen Bremner,1 Tamar Pincus,2 Anisur Rahman,3 Martin Underwood4
Tocite:CarnesD, ABSTRACT
ARTICLE SUMMARY
TaylorSJC,HomerK,etal. Introduction:Chronic musculoskeletal pain is a
Effectivenessandcost-
common condition that often responds poorly to Article focus
effectivenessofanovel,
groupself-management treatment. Self-management courses have been ▪ We outline all procedures for a pragmatic trial
courseforadultswith advocated as a non-drug pain management investigating the effectiveness of a self-manage-
chronicmusculoskeletalpain: technique, although evidence for their effectiveness ment intervention for chronic musculoskeletal
studyprotocolfora is equivocal. We designed and piloted a pain.
multicentre,randomised self-management course based on evidence for
controlledtrial(COPERS). effectiveness for specific course components and Key messages
BMJOpen2013;3:e002492. characteristics. ▪ Complex interventions need to be based on
doi:10.1136/bmjopen-2012- Methods/analysis: COPERS (coping with persistent evidenceandhavegoodtheoreticalunderpinning.
002492 pain, effectiveness research into self-management) is ▪ The value of pilot studies cannot be
a pragmatic randomised controlled trial testing the underestimated.
▸ Prepublicationhistoryfor effectiveness and cost-effectiveness of an intensive, ▪ Identifyingpatientswith non-electronically indexed
thispaperareavailable group, cognitive behavioural-based, theoretically conditionsisdifficult.
online.Toviewthesefiles informed and manualised self-management course
Strengths and limitations of this study
pleasevisitthejournalonline
(http://dx.doi.org/10.1136/ for chronic pain patients against a control of best ▪ Thisisacomplexinterventionwithgoodtheoret-
usual care: a pain education booklet and a relaxation
bmjopen-2012-002492). icalunderpinnings
CD. The course lasts for 15h, spread over 3days, ▪ The trial protocol was informed comprehensive
Received17December2012 with a –2h follow-up session 2weeks later. We aim pilotstudy
Revised17December2012 to recruit 685 participants with chronic ▪ Difficulties surround the identification patients
Accepted20December2012 musculoskeletal pain from primary, intermediate and
with non-electronically indexed conditions such
secondary care services in two UK regions. The
aschronicpain.
Thisfinalarticleisavailable study is powered to showa standardised mean
foruseunderthetermsof difference of 0.3 in the primary outcome, pain-related
theCreativeCommons
disability. Secondary outcomes include generic
AttributionNon-Commercial BACKGROUND
health-related quality of life, healthcare utilisation,
2.0Licence;see Chronic conditions, especially musculoskel-
pain self-efficacy, coping, depression, anxiety and
http://bmjopen.bmj.com
social engagement. Outcomes are measured at 6 and etal conditions, impose an increasing burden
12months postrandomisation. Pain self-efficacy is on healthcare systems and society.1 Point esti-
measured at 3months to assess whether change mates of the prevalence of chronic musculo-
mediates clinical effect. skeletal pain (pain lasting for longer than
Ethics/dissemination: Ethics approval was given the normal soft tissue healing time of
by Cambridgeshire Ethics 11/EE/046. This trial will around 12weeks2) range from 46% to 76%.3
provide robust data on the effectiveness and In 2008, the annual report on public health
cost-effectiveness of an evidence-based, group of the UK Chief Medical Officer identified
self-management programme for chronic
chronic pain as a major issue which needed
Fornumberedaffiliationssee musculoskeletal pain. The published outcomes will
to be addressed.4 Despite increased under-
endofarticle. help to inform future policy and practice around such
standing of the factors contributing to the
self-management courses, both nationally and
development of chronic pain,5 there has
Correspondenceto internationally.
DrDawnCarnes; Trial registration: ISRCTN24426731. been little improvement in how successfully
[email protected] it is treated and managed.6 Current
CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492 1
COPERS protocol
treatment tends to centre on drug regimens for pain related to improving posture and social activities, for
control and depression, physiotherapy and pain- example, art and massage. Self-efficacy has been
management programmes. However, many patients will reported as an important mediator for success in these
experience complex care pathways involving multiple types of ‘treatment’ approaches.21 Since healthcare pro-
referrals to secondary care and often unnecessary and fessionals and lay tutors have both been reported as
repeated diagnostic tests.7 effective facilitators for self-management programmes,
Several UK Department of Health reports have recom- we used both.22 23 There is mixed evidence for the
mended self-care for chronic disease as a strategy for optimal duration of self-management courses and ‘dose’
improving the long-term future of health in the UK.8–10 per week. Short weekly sessions over 6weeks or more
Since 2000, the UK has invested in the implementation are the usual model, but attendance can be poor.14
of lay-led (ie, peer-led) self-management training However, evidence from mental health research shows
courses, the Expert Patients Programme (EPP).10 The that brief/intensive interventions can be effective and
available evidence, however, suggests that these courses are often preferred.24 25 The COPERS course is deliv-
maynotreducehealthcareresourceuseasexpected11–13 ered as a 3-day intensive course on consecutive days, the
and that there are only modest short-term beneficial rationale being to address the high attrition often
effects on other outcomes. Very few studies have exam- reported anecdotallyin other programmes.14
inedthelong-termclinicaleffects.13–15 The protocol has been designed as a result of a feasi-
In response to the anomaly between continued UK gov- bility study which enabled us to modify our approach to
ernment support of self-management programmes and recruitment, intervention and to test a variety of
equivocal evidence of their effectiveness, the COPERS outcome measures. Recruitment was problematic in the
(coping with persistent pain, effectiveness research into feasibility studyas there is no specific electronic diagnos-
self-management) study (http://blizard.qmul.ac.uk/ tic code forchronic pain. We have since piloted a search
research-generation/329-copers.html) was commissioned strategy based on repeat prescriptions, ‘Read’ codes and
by the National Institute of Health Research (NIHR), as a frequency of visits, which identify many of our target
5-yearprogrammegranttoidentifywhichcomponentsand population. To optimise recruitment, we decided to also
characteristics of self-management and pain-management use face-to-face consultations and self-referral via adver-
programmes are the most effective, as well as to evaluate tisements in surgeries and clinics. We found that filling
these components in a trial, in order to inform both the courses within a set time period was difficult especially
development of a new pain self-management course and when, by chance, the majority of participants were ran-
the next generation of self-management courses in domised to the control. We have accommodated this by
general.Wecompletedtwosystematicreviewsandaqualita- using randomly varied permuted block randomisation
tive study that informed the development of the COPERS and phasing the recruitment of patients to specific time
intervention. One review collated the evidence base periods between schoolholidays.
for components and characteristics of pain and self- Weconvenedafocusgroupconsistingoftwoexpertsin
management courses and the other collated the evidence outcome measures, two general practitioners (GPs), two
for predictors, mediators and moderators of outcomes in psychologists and two patients with chronic pain. This
these programmes.16 17 In a qualitative study, we explored focus group selected the most appropriate measures to
the views and experiences of participants and tutors from test in the pilot trial. In addition to piloting quantitative
self-management courses about expectations, course datacollection,weevaluatedtheinterventionthoroughly
content,recruitment,tutoringandattendance.18Thefind- duringthepilotstudyusingfeedbackfromobservers,par-
ings from this work suggested that the group-delivered ticipants and facilitators. The pilot study indicated that
courses led by healthcare professionals and/or lay people theCOPERSself-managementcoursewasviableandwell
weremostlikelytobeeffective.Wealsofoundthatcourses received by participants, with good attendance (85% full
lasting for a shorter time appeared to be as effective as attendance). We found that the qualityof facilitation was
longer courses and that the setting in which courses were a key determinant for the success of a course and
delivered (ie, in healthcare settings or the community) invested more time and resources in facilitator training
appearedtomakelittledifferencetoanybeneficialeffects. and recruitment for the main trial. Additionally, we
Evidence also suggested that participants particularly found that the group nature of the course was valued
enjoyedtherelaxationelementsofcoursesbutwereaverse highly by participants; therefore, we allowed for more
toexercisebeingincluded. socialisingduringtheintervention.
Our systematic reviews found evidence to support psy-
chological approaches; therefore, we based our course Aims of the study
around concepts from cognitive behavioural therapyand The aim of this study isto establish the effectiveness and
acceptance and commitment therapy.19 20 Some ele- cost-effectivenessofthenewself-management (COPERS)
ments of the COPERS intervention are similar to the courseforthosewithchronicmusculoskeletalpain,when
EPP, such as the inclusion of relaxation, goal-setting and compared with usual care plus a CD recording of simple
action-planning and improving consultations with relaxation exercises (also received by the intervention
healthcare professionals. We also included sessions armviatheself-managementcourse).
2 CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492
COPERS protocol
Trial purpose attendance in the previous 3-month period. During pilot
This trial will provide the data needed by the National testing, these searches identified 5–7% of general practi-
Health Service (NHS) purchasers to decide whether or tioners as possibly eligible and roughly identified our
not tofund programmes ofthis nature. targetpopulationingeneralpractices.
The list of potential participants identified via elec-
tronic search is screened by clinicians at the practice or
METHODS/DESIGN
clinic to check suitability based on the eligibility criteria.
Trial design
Eligible patients are invited to join the study by letter
A multicentre pragmatic randomised controlled trial
from their GP or secondary care clinic. They are asked
(RCT) was conducted in the UK with unbalanced ran-
to complete an expression of interest form to send to
domisation (1.33: 1) (intervention:control) to accommo-
the study team or to contact the study team directly.
date for the effects of clustering. The unbalanced
Clinicians working in participating practices are also
randomisation may also improve recruitment; if partici-
able to invite patients consulting with chronic pain to
pants are told that they are more likely to receive the
participate by handing them an information pack.
active treatment, then they may be more likely to join
Finally, advertisements and invitation packs will be
the study.
placed in general practice and clinic waiting rooms to
attract interested patients, who can contact the study
Trial setting teamdirectlyfor further information.
The trial is based in northeast London, and in the
Coventry and Warwickshire region. Participants are
Recruitmentand informed consent
recruited from primary and secondary care settings,
People expressing an interest in the study, who are eli-
such as general practices, musculoskeletal physiotherapy
gible and available to participate, are sent a baseline
unitsand pain clinics. The population ofthesetwo local-
questionnaire, a trial consent form to complete and a
ities, taken together, is broadly representative of the UK
freepost envelope to return the questionnaire and trial
as awhole.
consent form to the study team. All participants are
telephoned and asked whether they need more infor-
Target population
mation, and the consent form is discussed before a
Inclusion criteria
member of the study team counter signs the consent
▸ People aged 18 or over with chronic musculoskeletal
form indicating informed consent. A summaryof partici-
pain of more than 3months.2 This includes pain
pant flow through the study is shown infigure 1.
from osteoarthritis and fibromyalgia or chronic wide-
spread pain.
Intervention group
Exclusion criteria The intervention is a group-based, facilitated learning
▸ Inability togiveinformed consent course supporting patientsto manage theirchronic pain
▸ Not fluent in English better. It is a complex intervention using psychological
▸ Chronic pain arising from activemalignant disease approaches which have been shown to promote behav-
▸ Pain from inflammatory arthritis, such as rheumatoid iourchange of proven benefit in low back pain.26–28 The
arthritis course also includes pain education, attention control,
▸ Serious activecomorbidityor terminalillness relaxationandvisualisationtechniques, socialinteraction
▸ Serious mental health or substance abuse issues and the opportunity to try a new activity unrelated to
which render the individual unable to attend the pain (table 1). Teaching and learning methods include
course. facilitated learning through group discussion, sharing
narratives and experiences to foster social interaction,
Participant recruitment problem solving, an educational DVD, role play, practis-
Participants are recruited from primary and secondary ing attention and distraction techniques and ‘good’
careusing threemethods. posture. We hypothesise that these group-delivered
Our mainmethod of recruitment willbe bulk mail outs courses with plenty of breaks for social interaction will
from targeted searches of the secondary care clinic and build confidence to manage chronic pain better, that is,
general practice electronic records. Electronic records are improve self-efficacy, improve social integration and,
searchedbyidentified keyliaisonstaff inthepracticesand where necessary, help re-activate participants to
clinics.Thesepersonneluseagenericsearchstrategydevel- re-engage in social activities.29 30 The intervention con-
opedandtestedbythestudyteam.Thesearchstrategyhas sists of a short course run in 1weekover 3days (typically
a tiered approach focusing on demographic data (patient Monday, Wednesday and Friday) during schoolhours
registered at the practice, alive and >18years old), repeat (10:00—14:45), with a 2h follow-up session 2weeks
prescriptions for analgesics, tricyclic antidepressants and later. The total course comprises 24 individual ‘compo-
anxiolytics, followed by clinical symptoms (eg, low-back nents’ spread over 15–16h. A detailed training manual
pain, back pain, osteoarthritis, fibromyalgia) and for facilitators was developed, tested and refined in the
CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492 3
COPERS protocol
Healthcare professional facilitators are recruited via
press releases about the study in professional magazines.
Lay facilitators are recruited via local contacts with com-
munity interest companies delivering self-management
type programmes (typically the Expert Patient
Programme, http://www.expertpatients.co.uk).
Trainingfacilitators
Facilitators attend a 2-day training course that covers the
course content, how to facilitate, dealing with difficult
situations and what to do if an adverse event occurs.
During the courses, the trainee facilitators are required
to demonstrate actively that they are good listeners,
empathic, flexible, able to encourage equal participation
and laughter, able to manage difficult people, and able
to introduce, lead and summarise sessions while putting
the course content into a chronic pain context. We also
assess their understanding of the course via a written
assessment at the end ofthe training.
Only facilitators who are assessed as competent (ie,
demonstrate the skills required during role plays and
provide written answers that illustrate an understanding
of the key concepts) will deliver the intervention. They
are to be paired with trained and experienced facilita-
tors from the pilot study for their first course to ensure
consistency of delivery and to promote confidence in
the newly trained facilitators.
Control group
In our pilot study, we found that a usual care control
arm was insufficient to encourage participation in the
trial. Our interviews and pilot studies suggested that par-
ticipants particularly enjoyed the relaxation part of the
courses, while our systematic review found little evidence
that the relaxation component of pain-management
courses had much observable beneficial effect. In this
trial, we include a ‘relaxation pack’ as the control inter-
vention to make participation more appealing. This
includes a simple audio CD of three breathing and
Figure1 Flowdiagramofthestudy. relaxation sequences, instructions and the rationale
behind them. The CD is also used and distributed on
the COPERS course. After randomisation, participants
pilot study. The manual provides the aims and theoret-
in the control group receive the relaxation pack and are
ical basisforeach component.
asked to practise relaxation at least once a day every day
In the absence of any evidence favouring a particular
for 3weeks (the same duration as the intervention) and
setting for such group self-management courses, courses
as oftenasthey likethereafter.
are held in local medical or community venues that are
In an attempt to ensure that all the study participants
accessible to participants (eg, with disabled parking and
receive best usual care, they are also given a copy of a
near to public transport). booklet, called the ‘The Pain Toolkit’,31 which is pub-
lished by the UK Department of Health and freely dis-
Recruitmentof facilitators for the intervention
tributed to UK GPs to give to any patient with chronic
Each course is led by two facilitators, a healthcare
pain.
professional (a professionally registered physiotherapist,
osteopath, chiropractor, occupational health practitioner
or psychologist) and a lay person with experience of Hypothesis
both living with chronic pain and of tutoring or facilitat- We hypothesised that the benefits of the intervention
ingsmall groups. will be improved function, greater self-confidence,
4 CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492
COPERS protocol
Table1 Outlineofthecourseandtheoreticalmodels
Day Sessions Moduleaims Theory
1 1:Introduction Understandingpainandacceptance AcceptanceandCommitment
2:PaineducationDVD Therapy1945
3:Acceptance:theuninvited
guest
Lunchbreak
Tasteractivity(eg,art) Distractfrompainperceptionwithphysicalactivity Attentionanddistraction
4:Pain,whenisitbearable Painisnotjustphysiological;itisapsychological, Biopsychosocialmodelof
andwhenisitnot? emotionalandsocialphenomenon medicine46
5:Thepaincycle Recognisingthepaincycleandsignpostingways Fearavoidanceand
out catastrophising47
6:Movementandposture Reducemuscletensiontoeasepainandbecome Physicaltherapyprinciples
7:Breathingandrelaxation awareofphysicalweaknessandstrengthenareas andAlexandertechnique,
(CDtrack1) biofeedback
2 8:Reflectionsfromdayone Improvesocialbonding,groupcohesionand Socialcognitivetheory,3048
communitysocialsupport sociallearningtheory29
9:Identifyingproblems,goal Recognisingerrorsinthinkinginordertopromote Cognitivetherapy,2049
settingandactionplanning aconstructive/rationalviewofasituation theoriesofreasonedaction
10:Barrierstochange— andplannedbehaviour,50–52
unhelpfulthinking rationalemotivetherapy53
Lunchbreak
Tasteractivity(eg,,art) Distractfrompainperceptionwithphysicalactivity Attentionanddistraction
11:Barrierstochange— Recognisingerrorsinthinkinginordertopromote Cognitivetherapy2049and
reframingnegativesto aconstructive/rationalviewofasituation theoriesofreasonedaction
positives andplannedbehaviour50–52
12:Attentioncontroland Distractfrompainperceptionusingvisualisation Attentioncontrol54
distraction
13:Identifyingthingsthat Reminderstoapplytechniquesascoping Embeddinglearning
makepainmoremanageable strategies
14:Movementandbalance Reducemuscletensiontoeasepain,become Physicaltherapyprinciples
15:Breathing,relaxationand awareofphysicalweaknessandstrengthenareas. andattentionmanagement54
visualisation Distractionfrompainperceptionusingvisualisation
(CDtrack2)
3 16:Reflectionsfromday2 Improvesocialbonding,groupcohesionand Socialcognitivetheory3048
communitysocialsupport
17:Communicationwith Promoteconstructivehealthcareconsultationsand Theoriesofreasonedaction
healthprofessionals effectivecommunication andplannedbehaviour50–52
18:Listeningskills andSocialcognitive
theory3048
19:Anger,irritabilityand Recognisingerrorsinthinkinginordertopromote Cognitivetherapy2049
frustration aconstructive/rationalviewofasituation theoriesofreasonedaction
andplannedbehaviour50–52
Lunchbreak
Tasteractivity(eg,art) Distractfrompainperceptionwithphysicalactivity Attentionmanagement
20:Movementandstretch Reducemuscletensiontoeasepain,become Physicaltherapyprinciples
21:Breathing,relaxationand awareofphysicalweaknessandstrengthenareas. andattentionmanagement54
mindfulness Distractionfrompainperceptionusingmindfulness
(CDtrack3)
22:Summingup Reminderstoapplytechniquesascoping Embeddinglearning
strategies
Follow-up 23:Reflectionsandnarratives Improvesocialbonding,groupcohesionand Socialcognitivetheory3048
communitysocialsupport
24:Managingsetbacks Reminderstoapplytechniquesascoping Embeddinglearning
strategies
better coping skills, increased social engagement and Outcomes
more appropriate healthcare resource use (table 2). For the main trial, we selected a group of measures
Ouroutcome measures reflect these domains. based on both the published literature regarding their
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Table2 Outcomemeasuresandotherdatacollection
Follow-up
Domain Measures (months)*
Painduration Numericalscale 0
Painintensity ChronicPainGrade(painintensitysubscale)33 0,6,12
Paindisability ChronicPainGrade(paindisabilitysubscale)33 0,6,12
QualityofLife EQ-5D(healthutility)55 0,6,12
Self-efficacy PainSelf-EfficacyQuestionnaire56 0,3,6,12
Mood HospitalAnxietyandDepressionScale57 0,6,12
Coping ChronicPainAcceptanceQuestionnaire58 0,6,12
Socialactivity HEIQ(Socialintegrationsubscale)59 0,6,12
GeneralHealth Censusglobalhealthquestion60 0,6,12
Demographics Age,NHSnumber,sex,ethnicity,educationalbackground,employmentstatus, 0
languagefluency,livingarrangements(aloneorwithothers)
Economic Healthcareresourceuse:primarycareconsultations,secondarycareconsultations, 0to12
analysis hospitaladmissions,surgeries,imaging,testsandprescriptionsfromgeneralpractice
electronicrecords
Comorbidities FromgeneralpracticeelectronicrecordsaccordingtotheCumulativeIllnessRating 12
Scale7
*Postrandomisation.
validity and reliability and the extent of their use in almost doubled when incentives were not conditional on
other studies and on the focus group and pilot study. response (1.71;1.29 to2.26).35
Secondaryoutcomes
Primaryoutcome
Table 2 shows our secondaryoutcomes.
Our primary outcome is pain-related disability (we are
not aiming to change pain severity in the short term, as
current understanding of the mechanism of chronic
Criteriafor withdrawal
pain suggests that it is unlikely to improve rapidly).32 To
All participants are free to withdraw from the study at
measure function, we chose a well-validated tool, the
any timewithout having to giveanyexplanation.
Chronic Pain Grade (CPG).33 The CPG is made up of
two constructs—pain intensityand pain-related disability.
Each construct has been validated separately. They are Sample size
scored independently and can be combined to produce The sample size calculation was based on detecting a
the Chronic Pain Grade.34 Our primaryoutcome is pain- standardised mean difference of 0.3 in pain-related dis-
relateddisability.Thismeasurehasthreequestionsabout ability between the intervention and control groups,
pain-related function, and the responder rates their cir- with a power of 80% at the 5% significance level. This
cumstance on a scale from 0 to 10. The pain-related dis- effect size is commensurate with the largest change seen
abilityscoreisthemeanofthethreequestions. in a recent systematic review of expert patient pro-
Since there is a paucity of evidence on the long-term grammes,14 and also with the sort of change effected by
effectiveness of these types of interventions,14 we will interventions for other chronic pain syndromes, such as
measure outcomes by a patient-completed postal ques- low back pain, on any continuous outcome measure.36
tionnaire at baseline (before randomisation) and at 6 A simple sample size calculation indicates that we would
and 12months after randomisation. There will be one require data on 350 subjects. We inflated the sample size
postal reminder for each follow-up datacollection point, because of the possibility of a ‘clustering’ effect in the
after which non-responders will be contacted by phone group intervention arm and chose the ratio between
to obtain the primary outcome and quality of life intervention and control participants to increase statis-
measures. To encourage completion and return of tical efficiency.37 Using an intracluster correlation coeffi-
questionnaires, wewill send participants a £5 ‘high-street cient of 0.1 and assuming, on average, 9 individuals
shop’ voucher redeemable in multiple stores on a non- providing data from each group resulted in 480 indivi-
conditional basis along with their 6-month and duals being needed with 275 in the intervention group
12-month questionnaires. This expression of appreci- and 205 in the control group (1.33:1 intervention:
ation has been shown to improve questionnaire return control). Allowing, conservatively, for a 30% loss to
rates. A Cochrane review has found that ‘the odds of follow-up (from an average of 13 individuals recruited
response’ were more than doubled when a monetary per group), we sought to randomise 685 participants
incentive was used (OR 2.02; 95% CI 1.79 to 2.27) and (391 intervention participants and 294 controls).
6 CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492
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Previous research and electronic record searches from Blindingand protection from bias
the pilot study indicated that around 5% of adults on Allbaselinedataarecollectedbyself-completedquestion-
GP registers consult with chronic musculoskeletal pain. nairepriortorandomisation.Afterallocation,however,it
Of these, based on our pilot study, we estimate that 10% is impossible to blind researchers and patients to alloca-
may be interested in participating in the trial and tion due to the nature of the intervention and the
around half of thesewill berecruited into the trial. unequalrandomisation.Incompliancewithourresearch
We estimated that around 80% of the population are ethics committee requirements, GPs are informed of
adults over 18years of age (www.statistics.gov.uk 2010). their patient’s enrolment into the trial but not of their
This means that to recruit our 685 participants, we allocation. Although participants are free to divulge this
needed a population base of around 342000 (342000 informationtotheirprimarycareteam,wefeelthisinfor-
registered patients of whom approximately 80% are mation in itself should have little impact on their care.
adults (274000). Five per cent of these may have Outcome data are by patient completed postal question-
chronic pain (13700), and of these, we estimate that naire. For non-responders, primary outcome data and
around 10% may express interest in the study (1370). the Euroqol instrument are collected over the phone by
Half of these may be recruited and enrolled (685). researchpersonnelblindtotreatmentallocationwhouse
Using an average, total GP list size of 7000, this equates asetscriptaskingparticipantsnottodivulgetheiralloca-
to around 49 practices. We estimate that we will recruit tionpriortoaskingthemfortheirdata.
between 12 and 14 patients per practice.
This may be an overestimate of the number of prac- Data management
tices needed as it does not account for participants All data are managed in line with PCTU standard oper-
recruited from pain or musculoskeletal physiotherapy ating procedures and subject to review by audit and the
clinics or from face-to-face invitations and advertise- Data Monitoring and Ethics Committee (DMEC). All
ments within general practices. After signing up to the electronic participant data are stored in encrypted and/
study,generalpracticesaregivenachoiceofrecruitment or password-protected files in a secure environment. A
phases corresponding to blocks of prebooked course database has been designed to manage the data input to
dates. Recruitment will be split roughly equally between ensure consistencyof practice and coding, with a built-in
eachof our studysites. audit trail enabling us to track all entries and changes.
Weareaimingto book participants into courses within Regular audit and double-checking of all primary out-
12weeks of randomisation. The minimum course size is comes will be conducted to ensure accuracy of data
nine, due to the cost implications of running more input, and a further random 10% of all data entry will
courses. If a course is undersubscribed (<9) at the be double-checked.
outset, it is either cancelled and those registered offered
alternative dates for other courses, or those from other Adverse event reporting
courses will be transferred to the more imminent These are reported via the facilitators. Minor adverse
courses wherepossible. incidents (eg, a participant being tearful and distressed
during a session) are logged and fed back to the study
team by the end of the course. Serious adverse events
related to the study (eg, extreme distress or expressing
Randomisation suicidal thoughts) are reported immediately to the study
The randomisation plan was developed by the Pragmatic principal investigator in accordance with good clinical
Clinical Trials Unit (PCTU) at Queen Mary, University practice guidelines and, where necessary, reported to
of London (http://blizard.qmul.ac.uk/pragmatic- the DMEC and the studysponsor.
clinical-trials-unit.html). Randomisation was stratified by
centre (the Midlands or London). To ensure that alloca- Statisticalanalysis
tion provides sufficient participants for each course, but We will use Stata,37 R38 and MLwiN,39 as appropriate, to
which cannot be predicted by researchers, we used ran- analyse the data. Descriptive statistics will be used to
domly varied permuted blocks of size 7 and 14 with an summarise the characteristics of participants in each
allocation ratio of 1.33:1 (intervention:control). Those arm of the trial. Outcomes at follow-up will be analysed
returning completed questionnaires were telephoned as dependent variables in mixed effects regression
by the study team. People who were able and willing to models. The model will include as covariates: baseline
participate and gave valid informed consent were rando- outcome measure, allocation (intervention or control),
mised over the phone. During the phone call, research- age, gender, study centre (London or the Midlands) as
ers entered the participant’s trial identification number fixed effects, and the intervention group as a random
and recruiting centre into a central randomisation effect. Where participants withdraw, we will compare the
service, ensuring allocation concealment and partici- characteristics of those withdrawing against those who
pants received immediate notification of theirallocation. remain inthe study.
Participants are then informed and either immediately Our primary analysis is an available case analysis
booked on acourse or sent arelaxation pack. following the intention-to-treat principles (http://
CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492 7
COPERS protocol
www.consort-statement.org/consort-statement/further- included in this information. A secondary analysis will
explanations/box6_intention-to-treat-analysis/). We will include broader societal costs such as the patients’
use mixed effects models appropriate for each outcome out-of-pocket treatments for their pain such as comple-
(linear, logistic, Poisson) with intervention arm, age and mentary therapies, mobility devices, private investigations
gender and baseline level of outcome as fixed effects andprivatehospitaladmissions.
and group as a random effect. The random effect will The data will be collected from three main sources:
only be present in the intervention arm. We will primary care utilisation from GP electronic records at
examine patterns of‘missingness’and conductasecond- 12months’ follow-up, SUS data from the local strategic
ary analysis using multiple imputation and assuming health bodies at 15months (since there is a 3-month
variables are missing at random. We will also conduct a ‘lag’ in the availabilityof SUS data) and patient-reported
complier-average causal effect analysis to estimate the cost and utility data from the 6-month and 12-month
effect of the intervention on compliers.40 We define questionnaires. Data on the costs of training sessions will
‘compliers’ as those who attend more than half of the be collected from trial records. Primary and intermedi-
course (ie, those present for at least 12 of the 24 course ate care unit costs will be derived from UK published
components). We are also interested in the dose inter- sources.41 The unit costs for medications will be
vention participants receive, and define ‘full’ exposure obtained from the Prescription Cost Analysis database
to the intervention as being present at 17– 24 individual for 2010.42 The unit costs for secondary care will be
course sessions, moderate exposure as being present at 9 basedon health resource groups.43
–16 components, and non-exposure as being present at If appropriate, we will use multiple imputation to
eight or fewer components. We will report effect esti- guard against any bias that may result from missing
mates with CIs. For selected outcomes, we will estimate EQ-5D or cost data. The imputation model will impute
the proportions who improve over the threshold of 30% missing data based on age, gender, study centre
from baseline, a figure commonly used in relation to (London or the Midlands), EQ-5D and cost. The imput-
back pain, and from this, we will estimate the numbers ation model for the intervention arm will also account
needed to be treated and the relative risks for improve- for clustering by group in the intervention arm (by
ment.36 If the analysis shows an effect of the interven- including the intervention group as arandom effect).
tion on our primary outcome (pain-related disability), Our primary economic analysis is a cost-utility analysis
we will conduct an exploratory analysis to explore over 12months, examining the cost per QALY gained
whether any of the following are moderators of the for all participants whowere assessed for EQ-5D prior to
effect: baseline duration of chronic pain, severity of randomisation and had SUS data extracts. Descriptive
pain-related disability and pain self-efficacy. We will also statistics will be used tosummarise the costs and QALYs.
conduct a mediator analysis to determine whether the We will use a mixed effects regression model to adjust
level of exposure to the intervention or a positive estimates for costs and QALYs for the following covari-
changeinself-efficacyfrom baseline to12weeks postran- ates: baseline outcome measure, allocation (intervention
domisation mediatesthe effects at 6 or 12months. or control), age, gender, study centre (London or the
Midlands) as fixed effects, and the intervention group as
Health economic analysis a random effect. The Incremental Cost Effectiveness
At 12months postrandomisation, we will conduct a Ratio (ICER) will be calculated using the QALYs for
cost-utility analysis using EQ-5D data to measure Quality each patient as a utility measurement along with the
Adjusted Life years (QALYs) from an NHS perspective. coststothe NHS incurred byeach patient, where:
Thecostswillcoverprimarycareservices,prescribedmedi-
cation, investigations, intermediate care referrals and sec-
ondary care (using secondary user services (SUS) data).
Primary care services include consultations with GPs and ðCostofintervention(cid:2)CostofcontrolÞ
ICER ¼
practice nurses, both scheduled and unscheduled. Utilityofintervention(cid:2)Utilityofcontrol
Intermediate care referrals data will be collected on
physiotherapy,mentalhealthservices(includingImproved
Access to Psychological Therapies referrals), podiatry,
community nursing, community rehabilitation and other The spread of the incremental cost-effectiveness ratio
unscheduled primary or community care (out-of-hours across the four quadrants of cost effectiveness will be
services and walk-in centres). SUS will include accident plotted, and we will use bootstrapping to estimate the
and emergency visits, outpatient appointments and CIs of our estimates. We also plan to assess the cost
inpatient episodes. The SUS data will have International utilityof the intervention using willingnessto pay thresh-
Classification of Disease 10 and Office of Population olds ranging between £0 and £4000044 and to run two
Censuses and Surveys codes which will provide informa- sensitivityanalyses:
tion about disease and billing data. Information derived 1. Excluding high-cost individuals (top 5%).
fromtheOfficeforNationalStatisticsdeathreportswillbe 2. Including costs from the societal perspective (out-of-
the filter for attrition by death, as the cause of death is pockettreatments for pain).
8 CarnesD,TaylorSJC,HomerK,etal.BMJOpen2013;3:e002492.doi:10.1136/bmjopen-2012-002492
COPERS protocol
Quality control andfidelityof intervention delivery 3. ParsonsS,BreenA,FosterNE,etal.Prevalenceandcomparative
The first day of each course is observed, and where we troublesomenessbyageofmusculoskeletalpainindifferentbody
locations.FamPract2007;24:308–16.
have first time facilitators, or facilitators who lack confi- 4. DonaldsonL.150yearsoftheAnnualReportoftheChiefMedical
dence, these courses are observed in their entirety to Officer:onthestateofpublichealth2008.DepartmentofHealth.
StationeryOffice;2008.http://www.dh.gov.uk/en/
check the fidelity of the intervention. In addition, every Publicationsandstatistics/Publications/AnnualReports/DH_096206
course is audiorecorded. A random selection of audio- (accessed17Jan2013).
taped sessions will be chosen for evaluation of fidelity. 5. WScoieonlfcCeJ2,0S0a0lt;e2r88M:1W7.6N5e–u9r.onalplasticity:increasingthegaininpain.
The evaluators will use a checklist to record adherence 6. CroftP.Islifebecomingmoreofapain?BMJ2000;320:1552–3.
to structure and content and facilitator competence. 7. HudonC,FortinM,VanasseA.CumulativeIllnessRatingScalewas
areliableandvalidindexinafamilypracticecontext.JClin
Feedback to facilitators will be provided, where neces- Epidemiol2005;58:603–8.
sary,so theycan modifyand improvetheir performance. 8. DarziA.Highqualitycareforall:NHSNextStageReviewfinal
report.DepartmentofHealth,StationeryOffice;2008.http://www.dh.
gov.uk/en/Publicationsandstatistics/Publications/Publications
PolicyAndGuidance/DH_085825(accessed17Jan2013).
CONCLUSION 9. WanlessD.Securingourfuturehealth:takingalong-termview—the
Thisdefinitivetrialwillproviderobustdataontheeffect- WanlessReport.DepartmentofHealth,StationeryOffice;2002.
http://webarchive.nationalarchives.gov.uk/+/http://www.hm-treasury.
iveness and cost-effectiveness of an optimised package of gov.uk/consult_wanless_final.htm(accessed17Jan2013).
care designed to improve self-management of chronic 10. DonaldsonL.Expertpatientsusherinaneweraofopportunityfor
theNHS.BMJ2003;326:1279–80.
pain. This will help to serve to inform future policy and
11. DepartmentofHealth.Theexpertpatient:anewapproachtochronic
practice for running self-management courses both diseasemanagementforthe21stcentury.DepartmentofHealth,
nationallyand internationally. StationeryOffice;2001.http://www.dh.gov.uk/en/Publicationsand
statistics/Publications/PublicationsPolicyandGuidance/DH_4006801
(accessed17Jan2013).
Trial status 12. Expertpatientprogramme.http://www.expertpatients.co.uk/
(accessed17Jan2013).
We anticipate that our results will be complete and sub- 13. GriffithsC,FosterG,RamsayJ,etal. Howeffectiveareexpert
mitted for peer review publication inJanuary 2014. patient(layled)educationprogrammesforchronicdisease?BMJ
2007;334:1254–6.
14. FosterG,TaylorSJC,EldridgeSE,etal.Self-management
Authoraffiliations educationprogrammesbylayleadersforpeoplewithchronic
1CentreforPrimaryCareandPublicHealth,BlizardInstituteBartsandThe conditions.CochraneDatabase SystRev2007;(4):CD005108.
15. KennedyA,ReevesD,BowerP,etal.Theeffectivenessandcost
LondonSchoolofMedicineandDentistry,QueenMaryUniversityofLondon,
effectivenessofanationallay-ledselfcaresupportprogrammefor
London,UK
patientswithlong-termconditions:apragmaticrandomised
2DepartmentofPsychology,RoyalHollowayUniversityofLondon,London, controlledtrial.JEpidemiolCommunityHealth2007;61:254–61.
UK 16. MilesCL,PincusT,CarnesD,etal.Canweidentifyhowprogrammes
3DepartmentofRheumatology,UniversityCollegeHospital,London,UK aimedatpromotingself-managementinmusculoskeletalpainwork
4ClinicalTrialsUnit,WarwickMedicalSchool,WarwickUniversity,Coventry, andwhobenefits?Asystematicreviewofsub-groupanalysiswithin
RCTs.EurJPain2011;15:775.e1–775.e11.
UK
17. CarnesD,HomerKE,MilesCL,etal.Effectivedeliverystylesand
Contributors MU,DCandSTconceivedtheoriginalideaforthestudy.ST, contentforself-managementinterventionsforchronicmusculoskeletal
pain:asystematicliteraturereview.ClinJPain2012;28:344–54.
MU,DC,KH,TPandARwereintegraltothedesignoftheinterventionand
18. CarnesD,HomerKE,UnderwoodM,etal.Self-management
thetrial,andSE,SBandMUwerespecificallyresponsibleforthestatistical
coursesforthosewithchronicmusculoskeletalpain:whotorefer
componentsofthetrialandthestatisticalanalysisprotocol.DCwrotethefirst andwhy?EurJPainSupplements2011;5:70–1.
draftoftheprotocol.KH,ST,MU,KH,AR,TPandSEcontributedtoeach 19. HayesSC,StrosahlKD,WilsonKG.Acceptanceandcommitment
successivedraftofthemanuscript,andallauthorsapprovedthefinalversion. therapy:anexperientialapproachtobehaviorchange.NewYork,
MUandSTarejointPIsforthestudy;DCisthetrialmanagerandKHthe USA:GuildfordPress,2004.
20. BeckJS.Cognitivetherapy.NewYork,USA:TheGuildfordPress,
seniorresearcher;SBandSEarethetrialstatisticians.ARandTPareonthe
1995.
trialmanagementboardandprovidedsubstantialinputintotheintervention 21. OsborneRH,ElsworthGR,WhitfieldK.TheHealthEducation
design. ImpactQuestionnaire(heiQ):anoutcomesandevaluationmeasure
forpatienteducationandself-managementinterventionsforpeople
Funding Thispaperpresentsindependentresearchcommissionedbythe withchronicconditions.PatientEducCouns2007;66:192–201.
NationalInstituteforHealthResearch(NIHR)underitsProgrammeGrantsfor 22. FransenM,McConnellS.Exerciseforosteoarthritisoftheknee.
AppliedResearchscheme(RP-PG-0707-10189).Theviewsexpressedinthis CochraneDatabaseSystRev2008(4):CD004376.
publicationarethoseoftheauthorsandnotnecessarilythoseoftheNHS,the 23. HaydenJA,vanTulderMW,TomlinsonG.Systematicreview:
NIHRortheDepartmentofHealth.Thisprojectbenefitedfromfacilitiesfunded strategiesforusingexercisetherapytoimproveoutcomesinchronic
lowbackpain.AnnInternMed2005;142:776–85.
throughtheBirminghamScienceCityTranslationalMedicineClinicalResearch
24. WattMC,StewartSH,LefaivreMJ,etal.Abriefcognitive-behavioral
andInfrastructureTrialsPlatform,withsupportfromAdvantageWestMidlands. approachtoreducinganxietysensitivitydecreasespain-related
anxiety.CognBehavTher2006;35:248–56.
Competinginterests None.
25. WisemanCV,SundaySR,KlapperF,etal.Short-termgroupCBT
Ethicsapproval CambridgeshireEthicsCommitteeprovidedafavourable versuspsycho-educationonaninpatienteatingdisorderunit.Eat
DisordJTreatPrev2002;10:313–20.
ethicalreviewforthisstudyRef:11/EE/046.TheISCTRNis24426731
26. LambSE,LallR,HansenZ,etal.Amulticentredrandomised
Provenanceandpeerreview Notcommissioned;internallypeerreviewed. controlledtrialofaprimarycare-basedcognitivebehavioural
programmeforlowbackpain.TheBackSkillsTraining(BeST)trial.
HealthTechnolAssess2010;14:1–253,iii–iv.
27. HenschkeN,OsteloRW,vanTulderMW,etal.Behavioural
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