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As you read the article, consider:  how well does the interpretation (also known as the “discussion”) section in each paper follow the recommended key elements, as described in this week’s readings? 
For each article:

Highlight at least 3 “best practices” you recognize in the interpretation section.
Recommend at least one revision to further strengthen the interpretation section.  If the section is truly “solid,” what revision would you suggest in the interpretation section for a different audience?757623
research-article2018
PMJ0010.1177/0269216318757623Palliative MedicineDunleavy et al.
Review Article
Using the ‘Social Marketing Mix
Framework’ to explore recruitment
barriers and facilitators in palliative care
randomised controlled trials? A narrative
synthesis review
Palliative Medicine
2018, Vol. 32(5) 990­–1009
© The Author(s) 2018
Reprints and permissions:
sagepub.co.uk/journalsPermissions.nav
https://doi.org/10.1177/0269216318757623
DOI: 10.1177/0269216318757623
journals.sagepub.com/home/pmj
Lesley Dunleavy, Catherine Walshe, Anna Oriani and
Nancy Preston
Abstract
Background: Effective recruitment to randomised controlled trials is critically important for a robust, trustworthy evidence base in
palliative care. Many trials fail to achieve recruitment targets, but the reasons for this are poorly understood. Understanding barriers
and facilitators is a critical step in designing optimal recruitment strategies.
Aim: To identify, explore and synthesise knowledge about recruitment barriers and facilitators in palliative care trials using the ‘6 Ps’
of the ‘Social Marketing Mix Framework’.
Design: A systematic review with narrative synthesis.
Data sources: Medline, CINAHL, PsycINFO and Embase databases (from January 1990 to early October 2016) were searched.
Papers included the following: interventional and qualitative studies addressing recruitment, palliative care randomised controlled trial
papers or reports containing narrative observations about the barriers, facilitators or strategies to increase recruitment.
Results: A total of 48 papers met the inclusion criteria. Uninterested participants (Product), burden of illness (Price) and ‘identifying
eligible participants’ were barriers. Careful messaging and the use of scripts/role play (Promotion) were recommended. The need
for intensive resources and gatekeeping by professionals were barriers while having research staff on-site and lead clinician support
(Working with Partners) was advocated. Most evidence is based on researchers’ own reports of experiences of recruiting to trials
rather than independent evaluation.
Conclusion: The ‘Social Marketing Mix Framework’ can help guide researchers when planning and implementing their recruitment
strategy but suggested strategies need to be tested within embedded clinical trials. The findings of this review are applicable to all
palliative care research and not just randomised controlled trials.
Keywords
Palliative care, palliative medicine, terminal care, randomised controlled trial
What is already known about the topic?
•• More randomised controlled trials (RCTs) are required in palliative care to provide the evidence to underpin our clinical
practice and care.
•• Palliative care RCTs struggle to achieve their recruitment targets.
•• The evidence related to the barriers and facilitators to recruitment in palliative care has not yet been synthesised.
International Observatory on End of Life Care, Division of Health
Research, Faculty of Health and Medicine, Lancaster University,
Lancaster, UK
Corresponding authors:
Catherine Walshe, International Observatory on End of Life Care,
Division of Health Research, Faculty of Health and Medicine, Lancaster
University, Furness C52, Lancaster LA1 4YG, UK.
Email: c.walshe@lancaster.ac.uk
Anna Oriani, International Observatory on End of Life Care, Division of
Health Research, Faculty of Health and Medicine, Lancaster University,
Furness Lancaster LA1 4YG, UK.
Email: anna.oriani.81@gmail.com
Nancy Preston, International Observatory on End of Life Care,
Division of Health Research, Faculty of Health and Medicine, Lancaster
University, Furness Lancaster LA1 4YG, UK.
Email: n.j.preston@lancaster.ac.uk
991
Dunleavy et al.
What this paper adds?
•• Uninterested participants (Product), burden of illness (Price), ‘identifying eligible participants’, the need for intensive
resources and gatekeeping by professionals (Working with Partners) are barriers to recruitment.
•• Careful messaging, the use of scripts/role play (Promotion), having research staff on-site and lead clinician support
(Working with Partners) are recommended.
Implications for practice, theory or policy
•• Current evidence about the barriers and facilitators to recruitment to RCTs in palliative care is mostly anecdotal.
•• The ‘Social Marketing Mix Framework’ can help guide researchers when planning and implementing their recruitment
strategy.
•• More methodological research is needed to help improve recruitment rates to palliative care RCTs.
Recruiting the required number of participants to palliative
care research studies is challenging. People can often be
‘hard to reach’ as they have a diverse range of conditions,
are cared for in a wide variety of clinical settings and have
unpredictable and complex needs. Recruitment to randomised controlled trials (RCTs) is especially difficult as
there are inherent challenges associated with this type of
research such as patient1,2 or clinician3 concerns about
assignment to a non-preferred treatment arm or to a placebo
arm. While recruitment challenges apply to all RCTs,4,5
these issues are often heightened in palliative care research
as the study population is particularly vulnerable and ‘there
is often no second opportunity to improve care’ (p. 70).6 The
difficulty of recruiting participants to palliative care RCTs is
reflected in the number of underpowered studies reported in
systematic reviews of palliative care interventions.7–9
We require adequately powered RCTs to evaluate the
safety and effectiveness of healthcare interventions. This
is not only essential to deliver high-quality end-of-life care
but is increasingly important as palliative care attempts to
justify its role within a complex and resource limited
healthcare system. As an example, an important recent
trial finding is that antipsychotic drugs are not beneficial in
reducing symptoms of delirium. These findings could be
put into practice more rapidly had it not taken over 5 years
to reach the target sample size.10
Why so many palliative care RCTs struggle or fail to
achieve their recruitment targets is an important area of clinical practice that is poorly understood. The use of a memory
aid, contact before arrival, cluster consent and ‘opt out’ consent improved recruitment of people with cancer or organ
failure into trials.11 Strategies that reduce the demand on
healthcare professionals such as a clinical recruiter or automated alert system were seen as the most promising strategies in a review focusing on research studies in general but
the studies that were assessed were at high risk of bias.12
Individuals or organisations prevent eligible patients from
entering a palliative care research study because of personal
feelings, perceptions and intuitions rather than a formal
assessment that involves the patient.13
This review is unique as it uses a theoretical framework,
the ‘Social Marketing Mix Framework’, to explore recruitment barriers, facilitators and strategies in palliative care
RCTs.14 Marketing focuses its efforts on meeting the needs
of customers by understanding the factors that can influence
their decisions to buy a product or sign up to a particular
scheme.15 Social marketing has been used in public health
for many years and applies marketing principles to programmes that aim to influence the behaviour of a particular
audience to improve their welfare or that of society as a
whole.14 The ‘Social Marketing Mix Framework’ has been
seen as a potentially useful theoretical framework to help
organise and plan recruitment activities as well as help to
identify factors that can be adjusted to maximise enrollment.14 It has been applied to trials recruiting the caregivers
of patients with Alzheimer’s disease,14,16 and elements of
the framework have been used in a successfully recruiting
palliative care service delivery trial.17
The aim of this review is to identify, explore and synthesise what is known about the recruitment barriers and
facilitators in palliative care RCTs using the ‘6 Ps’ of the
‘Social Marketing Mix Framework’ in order to develop
recommendations that can be used to increase recruitment in clinical practice. The ‘6 Ps’ used are the following: ‘Identifying participants’ which is defining your
target audience, the ‘Product’ which is the intervention,
the ‘Price’ which is the cost of taking part in the study
for participants, the ‘Place’ is where recruitment activity
takes place, ‘Promoting the study’ is how you reach your
target population and ‘Working with Partners’ relates to
organisations or individuals who allow access to
participants.14
Method
Design
Review question. What can the ‘6 Ps’ of the ‘Social Marketing Mix Framework’ tell us about the recruitment barriers
and facilitators in palliative care RCTs?
992
Palliative Medicine 32(5)
Table 1. Narrative synthesis framework.18
Element 1: the role of theory in
evidence synthesis
Element 2: developing a preliminary
synthesis
Element 3: exploring relationships
within and between studies
Element 4: assessing the robustness
of the synthesis
The ‘Social Marketing Mix Framework’ was the theory chosen.14 Theory in a review
informs the data extraction process, contributes to the interpretation of findings and is
valuable in assessing how widely applicable the findings may be in practice (p. 12).18
Descriptive data about each included study were organised into a table. Relevant sections
of included papers were coded line by line using predetermined and open codes. Codes
were then organised into categories and refined to develop broader themes.
Tabulation allowed themes to be conceptually mapped within the chosen theoretical
framework. This allowed the most common themes across all of the studies to be
identified as well as those that apply to the patient, carer or healthcare professional.
Under this approach, this involves an overall assessment of the strength of the evidence
for drawing conclusions on the basis of the narrative synthesis and being thorough while
critical of the methodological approach used to synthesise your findings (p. 15).18
Review design. A narrative approach to synthesis was chosen as this facilitates the incorporation of research and
non-research data, to provide new and valuable insights
into complex trial recruitment processes.18 This review has
been guided by a narrative synthesis framework made up
of four elements18 as well as the ‘6 Ps’ that make up the
‘Social Marketing Mix Framework’. Above is a brief overview of how the four elements of the framework have been
applied (see Table 1) and further details are discussed
within the relevant sections below.
Search strategy. Embase, Medline, PsycINFO and CINAHL
databases were searched from 1 January 1990 until 8 October 2016 (see Figure 1). The search included the terms palliat*, hospice* and ‘terminal care’ as they are seen as a
robust and valid strategy to identify and retrieve palliative
care literature.19–21 The search terms used within Medline
via EBSCO were palliat* or hospice* or terminal care or
palliative care/ or palliative medicine/ or terminal care/ (not
exploded) and randomi*ed controlled trial* or randomised
controlled trial/(publication and topic). The limits set were
human, papers published between 1 January 1990 and 8
October 2016 and RCTs. The strategy was modified as necessary for the other databases searched (see Supplementary
Data Table 1 for further details of the search terms used).
The reference lists of the included studies were also handsearched to identify additional papers specifically focusing
on recruitment to palliative care RCTs.
recruitment to a RCT and its subsequent analysis reported
in the included qualitative papers were extracted. Data in
the form of narrative observations located in the discussion
sections of RCT result papers or retrospective reports of
researchers’ experiences of recruiting to a trial were also
extracted. The amount of data extracted was variable
across the included studies. Data extraction was carried
out by L.D., but 10% of the papers were independently
verified (A.O.).
Data synthesis
Element 2: developing a preliminary synthesis. Relevant sections of the included papers were initially coded line by line.
A mixture of predetermined (priori) codes, the ‘6 Ps’ from the
‘Social Marketing Mix Framework’ (see Table 3)14 and open
codes were used to ensure important aspects of the data were
not missed during coding.23 Initial codes were then organised
into the overarching categories barriers, facilitators and strategies in NVivo. Strategies were viewed as interventions that
were implemented to support facilitators and overcome barriers. Within these categories, codes were merged as appropriate and refined into broader themes. Coding into themes was
carried out by L.D., but 50% of the papers coded were then
independently checked by A.O.
Study eligibility. The inclusion and exclusion criteria are
listed in Table 2. Titles and abstracts were screened by a
reviewer (L.D.) to identify potentially eligible papers and
another reviewer (A.O.) independently verified 10 % of
this search. L.D. screened the remaining full papers to
identify the final included papers.
Element 3: exploring relationships within and between studies. Tabulation allowed the overarching categories (barriers, facilitators and strategies) and the themes contained
within them to be conceptually mapped with the ‘Social
Marketing Mix Framework’ (see Supplementary Table 3).
This allowed for the most common themes across all studies to be identified as well as how they apply to the patient,
carer or healthcare professional. Potential strategies and
facilitators that may help address identified barriers identified in the literature can also be visualised.
Data extraction. NVivo 10 was used to support the data
extraction and synthesis process. Descriptive data about
each included study were extracted and organised into a
table (see Table 4). Interview data from patients taking part
in a palliative care RCT or professionals involved in
Quality assessment. RCT papers were included to identify
recruitment issues rather than assess robustness of findings; therefore, assessment of the methodological quality
of these papers was not carried out. A hierarchy of evidence tool was adapted to assess the level of evidence the
Dunleavy et al.
993
Figure 1. PRISMA flowchart.
Table 2. Inclusion and exclusion criteria.
Inclusion
Study population
Cancer
• Adult cancer patients with incurable disease (defined by tumour staging);
• Non-professional carers of cancer patients with incurable disease;
• Parents of children with incurable cancer.
Non-cancer
• Adults with a progressive, life-threatening disease (defined by classifications
of disease severity such as New York Heart Association Class, NB this
would include patients classed in the literature as ‘frail elderly’ if they were
receiving an intervention that was clearly a palliative care intervention;
• Non-professional carers of patients with a progressive, life-threatening
disease;
• Parents of children with a progressive, life-threatening disease.
Study design
The types of papers listed below were included if they contained information
about the barriers, facilitators or strategies to recruitment to palliative care
RCTs:
• Randomised controlled Trials: pilot/feasibility studies as well as full-scale
palliative care RCTs;
• Intervention studies testing recruitment strategies;
• Qualitative/observational studies that report barriers, facilitators or
strategies to recruitment to palliative care RCTs;
• Articles reporting narrative opinions and/or observations related to
conducting a palliative care RCT.
Exclusion
Study population
• Adult cancer patients with potentially
curable disease;
• Care of chronic non-life-threatening
conditions without a curative treatment
option;
• Those studies including patients with
both curable and incurable disease if it is
impossible to distinguish findings between
groups;
• Primary endpoint of the study is survival
or tumour/disease response (NB would be
included if the study is testing an intervention
that is clearly a palliative care intervention);22
• Neo adjuvant or adjuvant chemotherapy
studies;
• Palliative care RCTs only recruiting health
professionals.
Study design
Non randomised trials.
994
Palliative Medicine 32(5)
Table 3. The ‘6Ps’ of the Social Marketing Mix Framework.
Social Marketing Mix Framework (the 6 ‘Ps’)14
Definitions
Identifying participants
Product
Defining the product
Defining the target audience (p. 4).
The product’s competition
Price
Place (improving accessibility)
Promoting the study
Working With Partners
The intervention is the product (its scientific, theoretical basis, does it meet
the needs of the target audience?), the product must address a problem that is
perceived as serious and amenable to the intervention (p. 4).
The amount of competition for the participant’s time and energy (p. 5).
The cost to the potential participant of taking part in the study (e.g. financial,
time, physical and emotional effort). Things need to consider: type of costs and
how to minimise the costs (pp. 5–6).
‘The location where the participant will receive information about, or engage in,
the intervention’ (p. 6).
‘Identify the acceptable avenues that reach the target population’ (p. 7).
‘Partners are defined as organisations involved with a social change effort or
serving as conduits to target audiences’ (p. 8). Things to consider: partner
education, partner referrals and recruitment and barriers to partnering.
identified barriers, facilitators and strategies in the literature were based on (see Supplementary Data 2).24 No
papers were excluded based on their evidence scoring.
This approach was used as the methodology of included
papers was mixed and the majority contained non-research
evidence. This process allowed judgements to be made
about the quality of evidence and the weight that should be
given to the extracted data during the synthesis process.25
Results
This review includes studies testing recruitment strategies
(n = 3), qualitative explorations of recruitment issues
(n = 3) and trial reports (n = 14) reporting barriers and facilitators to recruitment. Most (n = 28) were methodological
papers exploring the design of exemplar trial(s). A contextual summary of the included papers with the level of evidence score noted is provided in Table 4.24
The greatest number of barriers, facilitators and strategies identified could be mapped within the ‘Working with
Partners’ category, and Table 3 (see Supplementary Data)
provides a visual overview of how the evidence is weighted
within the ‘6 Ps’.14
Identifying participants: defining the target
audience
Barriers: identifying participants who meet the study inclusion
criteria/difficulty predicting prognosis. The challenge of participant identification and complex inclusion criteria were
raised as issues.30,43,46,52,57,67,70,72 This can relate to the difficulty of predicting prognosis as part of the trial’s eligibility assessment,36,43,45,46,56,59 how palliative care is defined
in a particular country,70 too narrow and/or ambiguous
inclusion criteria43,57 and lack of suitable caregiver72 or
surrogate to gain proxy consent.30,67
Facilitator: broad study eligibility criteria. Including broad
study eligibility criteria in your protocol was seen as an aid
to recruitment as it ensured a high percentage of patients
screened met the study’s inclusion criteria.17,68
Strategy: the use of a physician prognostication tool. The use
of a physician prognostication tool to help define and identify those patients with an advanced life-limiting illness
who were likely to die within the next 12 months alongside
face-to-face screening by a clinician was used as successful strategy in a RCT of an interdisciplinary palliative care
needs evaluation.66
Developing the product
Defining the product
Barriers: participants not interested/clinical equipoise. A
number of papers highlighted high refusal rates as an
issue27,31,33,36,55,62,71 with the lack of clinical equipoise
being cited as a possible reason for this, with concerns
about being randomised to their non-preferred arm having an influence on whether or not patients agreed to
take part.62,71 A lack of belief in the intervention,31,33
the lack of an acceptable control,31 the feeling the intervention was not needed at that particular time27,33,62
and competing priorities55 were also cited as reasons
for refusal. These concerns about the intervention, the
control and randomisation also apply to healthcare professionals and may be one of the reasons for their gatekeeping.32,38,44,47,52,71
Facilitator: replicate clinical practice as much as possible. RCTs that replicated clinical practice in recruitment
sites as closely as possible were seen to be more likely
to be successful.68 If in recruitment sites clinical practice varied significantly from the processes outlined in the
A retrospective
report of strategies
successfully used in
a RCT.
All of the article.
A paper discussing
the recruitment
strategy and patient
reported reasons for
non-participation in
a RCT.
All of the article.
A report of challenges
faced during an
ongoing RCT.
Main section.
1. Abernethy
et al.26 (USA)
A retrospective report
of the experiences
of researchers who
attempted to set up
a RCT.
All of the article.
7. Buss and
Arnold32
(USA)
6. Bausewein
et al.31
(Germany)
5. Baskin et al.30
(USA)
A report of baseline
findings and solutions
to methodological
challenges faced during
a RCT.
Discussion section.
A paper examining
barriers to obtaining
informed consent by
examining the reasons
for non-enrolment of
eligible patients.
Results and discussion
section.
A paper reporting the
findings from a RCT
embedded within a
longitudinal study.
Discussion section.
4. Bakitas et al.,29
linked to
Bakitas et al.28
(USA)
3. Bakitas et al.28
linked to
Bakitas et al.29
(USA)
2. Ammari
et al.27
(Denmark)
Type of article and
section recruitment
was discussed
References
To determine the
use, acceptance and
effectiveness of a
hand-held fan to relieve
breathlessness, to evaluate
recruitment.
To measure the safety and
effectiveness of an antinausea agent.
To examine the outcomes
and acceptability of
palliative care approaches
compared with usual
hospital care.
To test an educational and
care management palliative
care intervention.
To test the efficacy of
a psychoeducational
intervention.
To investigate the effect of
a nurse-led basic palliative
care intervention.
To evaluate the safety
and efficacy of the drug
Alvimopan.
Aim original study
Table 4. Description of included studies.
RCT, doubleblinded
Single-centre
Phase II RCT
embedded within a
longitudinal study
Multicentre
RCT
Single-centre
RCT, clinicianblinded
Single-centre
RCT, clinicianblinded
Single-centre
Parallel group
RCT
Multicentre
RCT, doubleblinded
Multicentre
Method original
study
Advanced lung
cancer or COPD
hospital, hospice
home care and
two respiratory
practices
Home hospice
patients
Hospice at home
Advanced
dementia
patients and their
surrogates
Teaching hospital
Advanced cancer
patients and
carers
Oncology hospital
Failed in set up
Intervention: anti emetic cream;
control: placebo
Questionnaires
2a
2a
Interview, postal
questionnaires
Intervention: hand-held fan;
control: a wristband to serve as a
placebo.
N = 109 patients were
recruited to the main
study of which 70
took part in the RCT
N = 30 patients
in each arm
June 2006 to
November 2007
N = Not stated
2a
2a
Questionnaires
Semi-structured
interview with
a subgroup of
participants
Not stated
2a
Not stated
2a
Questionnaire
Intervention: ‘palliative care
approaches’; control: usual care
Intervention: weekly telephone
sessions with nurse. Optional
shared medical appointments with
palliative care nurse, physician and
other persons living with advanced
cancer; control: usual care
Intervention: a phone-based,
nurse-led educational, care
coordination palliative care
intervention model; control: usual
care
2a
Questionnaires
and blood samples
N = 74 of 146 eligible
patients, not stated
N = 322 between
November 2003 and
May 2007
N = 104 patients,
77 caregivers over
14 months
Level of
evidence
Data Collection
N = not stated
N = not stated
N = not stated
Intervention: a ‘family and copingorientated palliative home care
intervention’; control: usual care
N = 57, not stated
N = 504 families
between
October 2011
and February
2013
Advanced cancer
patients and
carers
Oncology hospital
Intervention: Alvimopan laxative
(two arms with different doses);
control: placebo
N = not stated
N = not stated
Cancer patients
Hospices,
palliative care
centres, oncology
clinics
Advanced cancer
patients and their
carers
Hospital
Type of intervention /control
Sample achieved over
how long
Target sample
over how long
Sample and
setting of original
study
Dunleavy et al.
995
A paper reporting the
findings of a phase II
RCT.
Discussion section.
A retrospective report
of the experiences of
researchers trying to
recruit to a RCT.
Introduction.
A paper describing
the approach used
in a large RCT and
discusses its impact
on palliative care
research.
Discussion section.
9. Clark et al.34
(Australia)
10. Cook et al.35
(UK)
13. Farquhar
et al.39 linked
to Farquhar
et al.40 (UK)
A paper reporting the
findings of a qualitative
study exploring
the experiences
of specialist
nurses involved in
recruitment to a RCT.
All of the article.
A paper reporting the
findings from a RCT.
Discussion section.
A paper reporting the
authors’ experiences
of recruiting to two
related RCTs.
Discussion section.
8. Buss et al.33
(USA)
11. Currow
et al.,36
linked to
LeBlanc
et al.17 and
Mitchell and
Abernethy37
(Australia)
12. Daniels and
Exley38 (UK)
Type of article and
section recruitment
was discussed
References
Table 4. (Continued)
COPD patients
and carers
Community
Hospice home
care team
specialist nurses
and the lead
researcher for
the RCT
Hospice
Qualitative study
Single-centre
Qualitative study: to
explore the experiences
of specialist nurses
involved in recruitment
to a RCT. Parent study:
a RCT to evaluate the
effectiveness of a new
community-based service.
To test the feasibility
of a single-blinded fast
track pragmatic RCT
for a breathlessness
intervention service.
Single-blinded fast
track pragmatic
RCT (feasibility)
Single-centre
Palliative care
patients
Palliative care
service
Palliative care unit
patients
Palliative care unit
A 2×2×2 factorial
cluster RCT
Single-centre
RCT
Single-centre
Patients in the
terminal phase of
their illness
Inpatient palliative
unit
Advanced cancer
Cancer centre
Longitudinal RCT
Multicentre
A pilot phase
II randomised,
crossover, doubleblinded, controlled
efficacy study.
Single-centre
Sample and
setting of original
study
Method original
study
To evaluate service-based
interventions.
To assess the effects
of three potential
xerostomia relieving
products.
To assess the feasibility of
early consent and a study
of hyoscine hydrobromide
and octreotide for
management of noisy
breathing at the end of
life.
To examine the impact
of CHESS on caregiver
outcomes of affect and
QOL.
Aim original study
N = 10 nurses and 1
researcher
N = 10 nurses
and 1 researcher
N = 14 patients 12
carers
N = 461 patients
Not stated
N = not stated
N = 28 patients
to the trial,
maximum
N = 4 over 5 months
Intervention: a breathlessness
intervention service immediately
for 8 weeks or after an 8-week
period on a waiting list during
which time they received standard
care.
N/A
The ‘Palliative Care Trial’
evaluated three interventions: case
conferences, general practitioner
education and patient education
Interviews and
questionnaires
(Continued)
2a
3
2a
Questionnaires
Semi-structured
interview and
focus group.
2a
3
Five-point
categorical scale
Not stated
2a
Survey
Intervention: a web-based
information and support system
(CHESS) Study 1 CHESS and
clinician rapport or CHESS
Study 2 CHESS and clinician
rapport or control access to
computer/Internet
Intervention: participants while
well and their proxies provided
written informed consent. If
NB were encountered, people
were randomised to 200 mcg
octreotide or 400 mcg hyoscine
hydrobromide subcutaneously.
If subsequent treatment was
needed, the other medication was
administered.
Not stated
Overall, 50% patient/
carer dyads enrolled
in the study
N = from April to
November 2001,
49 consented 21
randomised
Level of
evidence
Data Collection
Type of intervention /control
Sample achieved over
how long
N = Not stated
N = 10 with
complete data
126 patient/
carer dyads per
arm
Target sample
over how long
996
Palliative Medicine 32(5)
20. Hanson
et al.46 (USA)
19. Gorman
et al.45 (USA)
18. Goodwin
et al.44
(Canada)
17. Goldstein
et al.43 (USA)
16. Fowell
et al.42 (UK)
A paper describing
lessons learned during
an ongoing RCT.
Main section.
A paper reporting the
findings of a qualitative
study.
All of the paper.
A paper reporting the
findings of a feasibility
study that explored
cluster randomisation
and Zelen’s design.
Discussion section.
A report outlining
challenges faced by
researchers while
implementing a
RCT and solutions
introduced.
Discussion section.
A paper examining
recruitment to a
RCT and analysis of
recruitment figures.
Discussion section.
A poster presentation
describing and
analysing recruitment
trajectories and
strategies used in a
RCT.
All of the poster.
A paper presenting
the findings of a pilot
RCT.
Discussion section.
14. Farquhar
et al.40 linked
to Farquhar
et al.39 (UK)
15. Fischer
et al.41 (USA)
Type of article and
section recruitment
was discussed
References
Table 4. (Continued)
To compare the impact
on survival of group
psychosocial support
combined with educational
materials, to educational
materials alone.
To compare the effect of
home hospice care with
such care supplemented
with massage.
Qualitative study: to
describe barriers and
strategies for recruitment
during a palliative care
RCT. Parent study: a
RCT where patients are
randomised to discontinue
or continue on statins.
To evaluate the effect
of a communication
intervention on ACP and
the management of ICDs
(implantable cardioverterdefibrillator)
To explore the feasibility
of cluster randomisation
and Zelen’s design for
trials with dying patients.
Qualitative study
Parent study: non
blinded
Multicentre RCT.
RCT
Single-centre
RCT
Multicentre
Cluster RCT
Multicentre
Feasibility
crossover RCT
Multicentre
Pilot RCT
Single-centre
Qualitative study:
PIs (Principal
Investigator)
and CRCs
(clinical research
coordinators)
from nine sites
Parent study:
adults with limited
life expectancy
Advanced cancer
hospice
Metastatic breast
cancer
Cancer centres
Advanced heart
failure patients
and their
caregiver
Hospital
Patients with a
serious illness
who were
appropriate
for a palliative
approach
Hospital
Dying patients
Cancer oncology/
palliative care unit
Intervention: usual care
supplemented by five daily
massages; control: usual care
Intervention: discontinue statins;
control: continue statins
Qualitative study:
N = 18 site PIs and
CRCs
Parent study: N = 381
patients
Qualitative
study: all eligible
site PIs and
CRCs
Parent study:
not stated
Intervention: expressive–
supportive therapy combined with
educational materials and usual
care; control: educational materials
and usual care alone.
Intervention: aimed at clinicians,
interactive educational session,
reminders and individualised
feedback; control: no specific
communication training, feedback
or reminders
All participants received a packet
of linguistically matched materials
on palliative care. In addition,
intervention participants received
up to five home visits from
the bilingual, bicultural patient
navigator.
Both units used cluster
randomisation or randomised
consent for 3 months and then
‘crossed over’ designs for a further
3 months.
N = 75 patients in
2 years
N = 237 June
1993–December 1997
N = not stated
N = 6, all in the cluster
arm
N = 64 May 2010–Sept
2011
Intervention: a breathlessness
intervention service; control: not
stated
Type of intervention /control
N = 200 over
4 years
N = 256 over
3 years
N = 09/ 2011–08/
2015, 100
patients at each
site (six sites)
N = not stated
N = Not stated
N = not stated
N = not stated
Phase II COPD
patients only,
Phase III cancer
and non-cancer
Phase II pilot
single-blind fast
track RCT and
Phase III RCT
To test a breathlessness
intervention service for
advanced disease.
To determine the
feasibility of a patient
navigator intervention to
improve palliative care
outcomes for Latino
adults with serious illness.
Sample achieved over
how long
Target sample
over how long
Sample and
setting of original
study
Method original
study
Aim original study
Questionnaires
and daily logs via
a touch screen
laptop.
Qualitative study:
semi-structured
telephone
interviews at end
of recruitment.
Review of
recruitment rates
Parent study:
interviews and
medical record
reviews
3
2a
2a
2a
Survey
questionnaires/
medical record
review
Not stated
4
Medical record
review
2a
2a
Not stated
Questionnaire,
medical record
review
Level of
evidence
Data Collection
Dunleavy et al.
997
A paper reporting
the findings from two
palliative care RCTs.
Discussion section.
A paper presenting
the findings of a RCT.
Discussion section.
A paper discussing
the challenges of
conducting RCTS with
reference to ongoing
RCT.
Main body
A retrospective report
discussing the impact
of using different
recruitment strategies.
All of the article.
A paper reporting
findings of a RCT.
Discussion section.
A paper reporting
findings of a RCT.
Discussion section.
A retrospective
report of recruitment,
attrition and
compliance arising
from an RCT.
Discussion section.
A report outlining
challenges faced
during an ongoing
RCT, solutions
and keys strategies
implemented.
Main body
21. Hardy et al.47
(UK)
22. Higginson
et al.48 (UK)
23. Hudson
et al.49
(Australia)
24 Hussainy and
Marriott50
(Australia)
26. Jones et al.52
(UK)
27. Jordhøy
et al.53
(Norway)
28. Kruse et al.54
(USA)
25. Jones et al.51
(UK)
Type of article and
section recruitment
was discussed
References
Table 4. (Continued)
To determine whether
regular video conferencing
between informal
caregivers and the
hospice care team alters
caregivers’ perceptions
of pain management and
patients’ pain.
To compare
comprehensive palliative
care to conventional care.
To compare knowledge of
those who had interacted
with palliative care trained
pharmacists versus
control.
To test the acceptability
and feasibility of a patient
preference RCT of an
ACP intervention.
To test the effectiveness
of a rehabilitation
intervention.
To investigate a support
and information
programme for lay carers
of people receiving
palliative care.
To determine whether a
new palliative care service
improves outcomes.
To assess recruitment,
compliance and follow-up.
To determine the effect
of dexamethasone when
treating malignant bowel
obstruction.
Aim original study
Non-blinded RCT
Multicentre
Cluster RCT
Multicentre
Two-arm, wait list
control, RCT
Single-centre
Phase II patient
preference RCT
Multicentre
RCT
Single-centre
RCT
Multicentre
Primary
caregivers of
hospice patients
Hospice at home
Advanced cancer
and caregivers
community/
districts
Advanced cancer
Hospice day
therapy
Advanced cancer
Hospital and
hospice
advanced cancer
or their carers
palliative care
service
Patients with MS
and specialist
palliative care
needs and their
carers
Community
Carers of cancer
patients dying at
home
N = Not stated
N = 200 patients
in each arm over
2 years
N = 240 patients
over 1 year
N = 20 patients
or carers per
month, over
3 months, 30
pharmacies
N = 40 in each
arm
N = 110
N = 50 patients
N = not stated
Advanced cancer
Cancer centre
Double-blind,
placebo-controlled
crossover study.
Single-centre
Phase II fast track
RCT
Single-centre
Target sample
over how long
Sample and
setting of original
study
Method original
study
N = 249 caregivers
of 233 patients
randomised
N = 434 March
1995–November
1997
N = 41 over 1 year
Intervention: biweekly team
meetings through video or phone
conferencing; control: usual care
Intervention: complex
rehabilitation intervention plus
usual care; control: usual care
alone. Those in the control arm
joined a wait list and were offered
the intervention 3 months after
randomisation.
Intervention: palliative medicine
unit organised care; control:
conventional care
Intervention: structured ACP;
control: usual care
2a
2a
2a
Questionnaires
Questionnaires
Questionnaires
and interview
(Continued)
2a
Questionnaires
2a
Not stated
Intervention: pharmacists who had
extra education in palliative care;
control: pharmacists who had no
additional education
N = 42, 36
pharmacies14
pharmacies were
randomised
N = 77
2a
Questionnaires
Intervention: nursing support and
information programme; control:
standard community palliative care
support
2a
2a
Not stated
Intervention: IV dexamethasone;
control: placebo, normal saline if
obstruction still present at day 5,
the patient was ‘crossed over’ to
the other arm
Intervention: an innovative
palliative care service; control: the
above after a >3-month wait and
until then received standard best
practice
Interviews
Level of
evidence
Data Collection
Type of intervention /control
N = 106
Trial 1: 25 patients
over 36 months;
Trial 2: 14 patients
in 24 months, study
terminated
N = 52, 1 year
Sample achieved over
how long
998
Palliative Medicine 32(5)
A paper describing
the strategies
and responses to
methodological
challenges faced during
a RCT.
Main body.
A paper reporting the
findings from a RCT.
Discussion section.
A retrospective report
of the recruitment
challenges faced during
a RCT and how they
were approached and
overcome.
All of the paper.
A paper reporting the
findings and difficulties
encountered during a
feasibility RCT.
Discussion section.
A report of the
researchers’
experiences accruing
patients after the first
year of a RCT with
an analysis of the
recruitment data.
Discussion section.
A report outlining the
challenges of carrying
out RCTs in palliative
care.
Introduction
A letter outlining
the researchers’
experiences of
recruiting to a RCT.
All of the letter
29. Kutner
et al.55 (USA)
31. LeBlanc
et al.17 linked
to Currow
et al.36 and
Mitchell and
Abernethy37
(Australia)
32. Lee et al.57
(New
Zealand)
33. McMillian
and
Weitzner58
(USA)
35. Miller and
Chibnall,60
linked to
Miller et al.61
(USA)
34. McWhinney
et al.59
(Canada)
30. Latimer
et al.56
(Canada)
Type of article and
section recruitment
was discussed
References
Table 4. (Continued)
Not stated
To evaluate a palliative
care home support team.
To assess the feasibility
of conducting a Phase
III RCT investigating
the therapeutic value of
gastrografin in malignant
bowel obstruction.
Not stated
To test different service
delivery models to
improve pain control in
the palliative setting.
To determine the
effectiveness and efficiency
of a Patient Care
Travelling Record©.
To investigate the efficacy
of massage therapy for
decreasing pain.
Aim original study
RCT
Multicentre
RCT with wait list
design
Single-centre
Three-arm RCT
Single-centre
Randomised
double-blinded
placebo-controlled
feasibility study
Single-centre
A 2×2×2 factorial
RCT
Single-centre
Ambulatory
patients with
life-threatening
illnesses
Hospital
Advanced cancer
patients and their
caregiver
Community
Advanced cancer
patients and their
caregiver
Hospice home
care
Advanced cancer
Hospital
Patients under
the palliative care
team
Hospital
outpatients
Palliative care
service patients
(or their legal
proxy) and their
GP.
Palliative care
service
Advanced cancer
patients
palliative care/
hospice settings
RCT
Multicentre
RCT
Single-centre
Sample and
setting of original
study
Method original
study
N = 300 over
6 months
N = 110 per
group
N = 846 in
28 months
N = After 12 months,
98 recruited
N = 146
N = 125 patient/
caregiver dyads over
9 months
N = 9 enrolled
N = 461 patients over
26 months
N = 460 patients
over 26 months
N = 20 patients
over 8 months
N = 46 randomised
over 2 years
N = 380 over
36 months
N = 440,
modified to 380
N = 90 (45
each arm) over
2 years
Sample achieved over
how long
Target sample
over how long
Intervention: tool designed to
help patients prepare for ‘a good
death’; control: not stated
Intervention: palliative care home
support team; control: received
intervention after 1 month
Intervention: standard care plus
supportive visits or standard
care plus teaching of a method
of coping with patient symptoms;
control: standard care
Intervention: (1) individualised
interdisciplinary case conference
with their GP versus control, (2)
educational outreach visitation
to GPs about pain management
versus control, (3) structured
educational visitation for patients
and caregivers about pain
management versus control
Intervention: gastrografin; control:
placebo
Intervention: the ‘Patient Care
Travelling Record’; control: usual
care
Intervention: massage therapy;
control: simple touch
Type of intervention /control
Not stated
2a
2a
2a
Questionnaires
Questionnaire,
nausea and pain
diary
2a
2a
Not stated
Questionnaires
2a
2a
Level of
evidence
Questionnaires
Not stated
Data Collection
Dunleavy et al.
999
Type of article and
section recruitment
was discussed
A paper reporting the
findings of a RCT.
Discussion section.
A retrospective
comparative study
of two palliative care
RCTs.
Discussion section.
A paper reporting the
findings of a feasibility
study to inform the
design of a RCT.
Qualitative study
results section.
A paper reporting the
findings of a RCT.
Discussion section.
A paper reporting the
findings of a RCT.
Discussion section.
References
36. Miller et al.61
linked to
Miller and
Chibnall60
(USA)
37. Mitchell and
Abernethy37
linked to
LeBlanc
et al.17 and
Currow
et al.36
(Australia)
38. Noble et al.62
(UK)
39. Philip et al.63
(Australia)
40. Prentice
et al.64 (UK)
Table 4. (Continued)
To determine whether
topical benzydamine
hydrochloride 3% cream
is more effective than
placebo in reducing pain
related to pressure areas.
To examine the effect of
oxygen versus air on the
relief of dyspnoea.
To identify the most
effective length of
anticoagulation for
treatment of cancerassociated thrombosis
(CAT). To identify the
practicalities of conducting
a full RCT.
QCC (Queensland Case
Conferences trial) and
PCT: (Palliative Care Trial)
to assess the effect of case
conferences that included
GPs and the palliative care
team.
To evaluate the effects of
a programme to address
psychosocio-spiritual
needs.
Aim original study
Randomised
double-blind,
placebo-controlled
trial.
Multicentre
Randomised,
double-blind,
crossover trial
Multicentre
Feasibility
study RCT
with embedded
qualitative study
multicentre
Hospice cancer
inpatients with
pain related to
pressure areas.
Palliative care
units
Advanced cancer
Cancer centres,
inpatients and
outpatients
Patients with
locally advanced
or metastatic
cancer
Oncology
outpatients
N = 30 patients
into each study
group.
N = Stage 1
62 patients
registered.
If at least 15
randomised then
stage 2 would
occur, until 200
patients had
been registered
Qualitative
study: 40–60
patients 10–15
carers
N = 50
N = 31 patients
N = 51 over 5 years
N = 5 December
2013–June 2014.
Qualitative study: 15
patients
1 carer
QCC: N = randomised
159 (72%) of
the target July
2001–May 2003; PCT:
N = randomised 461
(100%) participants
April 2002-June 2004
QCC
N = 220
PCT:
N = 460
QCC and PCC:
palliative care
patients
QCC/PCT:
palliative care
service
N = 98
N = Not stated
Patients with
a limited life
expectancy
Hospital
Randomised pretest–post-test trial
Multicentre
QCC: RCT
PCT:
Pragmatic 2×2×2
factorial cluster
RCT
QCC: multicentre
PCT: Single-centre
Sample achieved over
how long
Target sample
over how long
Sample and
setting of original
study
Method original
study
Randomised to receive either air
or oxygen via nasal prongs for
15 min. Then, following a 30-min
interval without gas, repeat
measurements were taken with
crossover to the other gas for a
further 15 min.
Intervention: a single application
of benzydamine hydrochloride 3%
cream to the painful pressure area;
control: placebo cream to the
painful pressure area.
Ongoing LMWH treatment for
CAT versus cessation of LMWH at
6 months’ treatment
Intervention: a group intervention
entitled ‘Life-Threatening Illness
Supportive-Affective Group
Experience’ for reducing patient
spiritual, emotional and death
related distress.
Control-standard care
QCC Intervention: case
conferences conducted at routine
palliative care team meetings. GPs
participated by teleconference
PCT Intervention: interdisciplinary
case conference including GP
conducted at patient’s home.
Type of intervention /control
2a
QCC: short
data collection
instrument, data
collected by
research assistant
PCT: data
collection by
clinical nurses as
part of routine
care
Blood tests,
diary cards, QOL
questionnaires
Pain scales
Questionnaires,
oxygen saturation
pulse oximetry
2a
Questionnaires
(Continued)
2a
2a
3
Level of
evidence
Data Collection
1000
Palliative Medicine 32(5)
A paper detailing a
method of obtaining
advance consent for a
RCT and the interim
recruitment results.
All of the paper.
The paper describes
the methodological
challenges faced
during a RCT and the
strategies used to
overcome them.
Main body.
A paper reporting the
findings of a RCT.
Discussion section.
A paper presenting
suggestions made
during a national
clinical research
forum.
Main body
A letter outlining the
challenges faced by
a researcher while
trying to recruit to
three RCTs.
All of the letter.
A paper reporting the
findings of a RCT.
Discussion section.
41. Rees and
Hardy65
(UK)
42. Riopelle
et al.66 (USA)
44. Shelby-James
et al.68
(Australia)
45. Storey69
(USA)
46. Vermandere
et al.70 (the
Netherlands)
43. Sampson
et al.67 (UK)
Type of article and
section recruitment
was discussed
References
Table 4. (Continued)
To investigate the effect
of a structured spiritual
history taking on the
spiritual well-being of
palliative patients in home
care.
Not stated
N/A
To assess the feasibility
of implementing a ACP
intervention.
To evaluate a palliative
care intervention for
Veterans.
A feasibility study of an
advance consent process
to support a RCT of two
anti-muscarinic drugs in
the management of noisy
respirations.
Aim original study
Cluster RCT
Multicentre
1. Placebo RCT
2. RCT
3. RCT
Multicentre
Initially a twoarm feasibility
cluster RCT
then amended to
individual level
randomisation
Single
14 clinical studies
were discussed,
12 of which were
double-blind RCTs
Hospice/palliative
care hospital
patients:
1. Hospices
2. Cancer centre
and a hospice
3. Hospital that
specialises in
cardiac care
Incurable,
life-threatening
disease
Home care
N/A
Advanced
dementia and an
informal carer for
proxy consent
hospital
275 patient–
provider dyads.
not stated
N/A
N = 40 patient/
carer dyads to
each study arm.
N = not stated
N = 99 patients,
245 HCPs, April to
October 2013
To date, the
Australian Palliative
Care Clinical
Studies Group has
randomised more
than 500 participants
across 12 sites in 8
Phase III studies.
1. N = not stated
2. Screened almost
2000 hospice patients,
21 recruited
3. No patients in a
year
N = 33 patients and
carers
N = 400 patients/289
caregivers from
August 2004 to
November 2006
2a
2a
Not stated
1. Intervention: Mexilitine. for
severe neuropathic pain; control:
placebo
2. Intervention: psychological
intervention to increase
forgiveness control: not stated.
3. Intervention: low-dose
oxycodone for breathlessness in
advanced HF; control: not stated
Intervention: healthcare providers
took a spiritual history on the
basis of the ‘Ars moriendi’ model;
control: usual care
Questionnaires
2b
2a
Questionnaires
N/A
2a
Patients:
interviews
caregivers:
Interviews
N/A
Intervention: a palliative care
patient assessment which informed
an ACP discussion with the carer;
control: usual care
Intervention: palliative care needs
evaluation conducted by an
interdisciplinary team, followed by
ongoing nurse case management;
control: usual care
3
Not stated
consent checked
on each admission
Intervention: to receive either
hyoscine or glycopyrronium at the
time of death
From May to
November 2002, 58
patients consented
Of these, 15
developed death rattle
and were
randomised
N = 75–100
patients a year,
complete the
study in three
years.
patients admitted
to a palliative care
ward who may
develop ‘death
rattle’
palliative care
wards in a cancer
centre.
Patients with an
advanced lifelimiting illness and
their caregiver
Hospital
Feasibility study
of an advance
consent process
embedded within
a RCT
single
Longitudinal RCT
Single-centre
Level of
evidence
Data Collection
Type of intervention /control
Sample achieved over
how long
Target sample
over how long
Sample and
setting of original
study
Method original
study
Dunleavy et al.
1001
This paper examines
the challenges
encountered in the
design and execution
of a RCT.
Main body
A report outlining
the challenges of
recruiting to a RCT.
Discussion section.
47. Westcombe
et al.71 (UK)
To test the feasibility
of delivering the COPE
psychoeducational
intervention.
To examine the
effectiveness of
aromatherapy in
improving psychological
distress and quality of life.
Aim original study
RCT
Single-centre
RCT
Multicentre
Method original
study
Heart failure
patients and
caregivers
hospice
Originally
advanced cancer
then included all
stages of cancer
Cancer centre
Sample and
setting of original
study
N = 32
not stated
Questionnaires
2a
2a
Questionnaires
Intervention: aromatherapy
massage; control: the first was
a no-intervention control and
the second relaxation therapy.
Relaxation therapy arm removed
during the trial.
Intervention: psychoeducational
intervention for caregivers;
control: not stated
N = 289 over 4 years,
75% longer than
expected.
N = original
target was 508,
reduced the
number required
from 508 to 258.
N = 84 dyads
Not stated
Level of
evidence
Data Collection
Type of intervention /control
Sample achieved over
how long
Target sample
over how long
RCT: randomised controlled trial; COPD: chronic obstructive pulmonary disease; CHESS: Comprehensive Health Enhancement Support System; QOL: quality of life; ACP: Advance Care Planning; LMWH: low-molecular-weight heparin; HF: heart failure; HCPs: Health care providers.
48. Zambroski
et al.72 (USA)
Type of article and
section recruitment
was discussed
References
Table 4. (Continued)
1002
Palliative Medicine 32(5)
1003
Dunleavy et al.
protocol, clinicians were likely to limit the number of participants they approached or avoid approaching altogether.68
Facilitator: offer a desirable and novel intervention. Offering a palliative care symptom control intervention to a
group of patients who normally have limited access to such
specialist input was suggested as a possible facilitator.39
Strategies: study design. A fast track design RCT with
a short lead in time may have increased the response rate
in a trial of a breathless intervention service as patients
and families knew they were going to get the intervention
either straight away or only after a short wait.39 There were
reports of researchers simplifying their study design during the recruitment phase of the trial. They reduced the
number of study arms to reduce the number of participants
required to ensure statistical power was achieved.33,71
There were strategies specifically suggested to help
improve recruitment rates in drug trials. Giving patients
the option to enter an extension study after taking part in a
placebo-controlled symptom control, RCT was seen as
important as enrolment was delayed for many patients
until this was put into place.26 Clinician’s fears that patients
will be left with uncontrolled symptoms if they are randomised to the control arm can be reduced with the inclusion of rescue medications in the study design.68
The product’s competition
Barrier: competing services/competing trials. Potential
participant’s being able to access information or support
services similar to those being offered as part of a study in
the recruitment centre or local area was seen as a barrier to
recruitment. Patients were able to access similar therapies
and support services without having to accept the restriction of randomisation.44,71 Competing trials recruiting
from a similar patient population was also seen as barrier
in one paper.44
Price: managing the price
Type of costs
Barrier: patient’s condition and illness. Patients and
caregivers being too burdened by the illness to participate,27,46,56,58,62 and the reality of having to deal with the
unpredictable nature of the patient’s disease in the recruitment process56,63 were seen as significant barriers. The
right time to approach was seen as an issue in one study,33
with patients citing the time around their initial diagnosis
being the wrong time while others offered the intervention
at the end of treatment would have preferred the intervention earlier.
Barrier: carer and patient gatekeeping. Gatekeeping by
caregivers was also identified as an issue46,58,72 with reports
of carers feeling protective towards their loved ones46,58,72
so blocking researcher access to the patient. These findings
correspond with a recent review focusing on gatekeeping
in palliative care research generally.13 In addition, this
review identified ‘gatekeeping’ by patients also as an issue
in studies that aimed to recruit patient/carer dyads. This
took the form of patients refusing to allow their caregivers
to be approached49 or expressing concerns about the additional burden the study would place on their caregivers
as well as making a decision that the caregiver would not
derive any benefit from being involved in the research.33
Minimising the costs
Facilitator: minimise burden for participants. There was
consensus among a group of palliative care trial experts
that recruitment success depended on minimising the burden of taking part in a trial for patients, carers and clinical staff.68 This involved limiting what was required from
those participants who agreed to take part in a study.
Strategies: consent. Strategies to minimise the costs of
taking part in the study for participants were related to the
informed consent process. Recruitment over the phone
using verbal consent procedures was seen as a successful
recruitment strategy for enrolling caregivers as they were
sometimes unavailable at the time of patient consent.66
This allowed carers to be contacted and recruited at a later
point in time, and it prevented the delays which can be
associated with face to face consent. The use of advance
consent to improve recruitment rates has been used in two
feasibility RCTs34,65 and was found to be a workable consent process for patients who are unable to give consent
at the time of randomisation. The use of Zelen consent
(only those randomised to the experimental treatment need
to be individually consented) versus cluster consent was
tested within a feasibility RCT.42 The findings suggested
cluster randomisation may be a more helpful approach for
increasing recruitment rates in trials with dying patients as
nurses were reluctant to approach dying patients for consent to change of treatment.
Place: improving accessibility
Barrier: recruitment setting. The issue of travel was identified as a reason for patients declining a quality-of-life
RCT71 in an oncology hospital as these types of interventions can often be provided locally while cancer treatment
trials are only available in oncology units. Late referral to
hospice services was also seen as a barrier to recruitment
as patients were often too ill to take part in the study.69,72
Hospice catchment areas could also be too small to provide the necessary pool of potentially eligible patients.72
Attempting to recruit participants during hospitalisation
was seen to be challenging as building rapport and trust
with participants during such a stressful time can be difficult.41,67 The role of specialist palliative care as a hospital
1004
consulting rather than admitting service was a barrier in a
trial recruiting patients with malignant bowel obstruction.57 In contrast, recruiting participants after discharge
was seen as more difficult in a couple of papers46,58 with
the feeling participants can be less-receptive.46 The physical environment and the often complex nature of patient
consultations in the outpatient setting are seen to make
approaching participants more difficult.46,56
Strategy: increase the number of recruitment centres. Increasing the number of recruitment sites during the trial to
increase the pool of potential participants was a strategy
employed by a number of studies to improve their recruitment rates.26,44,71 Some studies were set up as multicentre
studies, but this did not always guarantee recruitment
success.37,50
Promoting the study
Facilitators: key/careful messaging/flexibility and persistence. The importance of paying attention to key and
careful messaging when discussing a trial with patients,
carers and clinical staff to provide reassurance and to
address any concerns was seen as important.17,26,39,45,46,55,68
Recruiting staff also need to ensure they are flexible and
demonstrate respectful persistence46,66 while developing
a rapport with the patient.66
Strategy: role play/scripts. The use of role play and scripts to
ensure those involved in the recruitment process use predefined key messaging when introducing a study to
patients and carers is seen as a useful strategy.17,26,37,41,54,68
One study described how it had refined its recruitment
script during its pilot study to avoid introducing terms such
as hospice and end-of-life care early on and decided to
focus on quality of life instead.41
Palliative Medicine 32(5)
stressed to be approached.49 A lack of belief in the intervention,44,61,71 concerns regarding randomisation,38,44,71 the
use of placebo32,47,69 and clinical equipoise,44,52,71 lack of
confidence discussing a challenging study42,51 and fear of
discussing prognosis52,53,70 were also cited as possible reasons.
Barrier: research ethics committee gatekeeping. Research
ethics committees (RECs) play an important role in ensuring ethical standards are met in research and the rights
of those taking part are protected. RECs were seen at
times not to have a good understanding of palliative care
research which led to a misapplication of their gatekeeping role.73 This resulted in overly paternalistic recruitment
procedures being put in place such as face-to-face consent
in the community by a Doctor32 and insisting patients were
informed they had a prognosis of 6 months or less before
they could be approached.69
Barrier: resources. Recruitment to palliative care RCTs
is seen as a costly and labour intensive process. A large
number of patients have to be screened from a variety of
settings in order to find the participants that are eventually
recruited to the study, and the majority of research staff time
is spent screening and consenting rather than carrying out
the intervention and collecting data.34,38,46,58,72 Not having
the necessary staff available due to staff turnover or holidays,37 clinical staff being too busy41or lack of out of hours
cover47,57 is seen as having an impact on recruitment rates.
This aspect of the ‘Social Marketing Mix Framework’ is
divided into three areas: barriers to partnering, partner
education and partner referrals and recruitment.
Partner education
Strategy: personal repeated contact with referral
sources. Personal and repeated contact with referral
sources was seen as crucial to create and maintain enthusiasm and motivation throughout the life of the study as
well as address any concerns that may develop.17,37,38,53,64
The approaches used included presentations, regular meetings and involvement of clinical staff in the study design
and procedure development.17 Identifying an enthusiastic
study champion to assist access to potential participants
and help promote the study among patients and clinical
staff was also seen as a valuable strategy.46,55,60,71
Barriers to partnering
Barrier: healthcare professional gatekeeping. ‘Gatekeeping’ was seen as a barrier to recruitment to RCTs in palliative care with the majority of papers identifying healthcare
professional gatekeeping as the most difficult issue to overcome.32,35,44,46,49–52,55,56,61,64,70,71 Gatekeeping in this context
is when healthcare professionals prevent the researcher
from approaching eligible patients and/or carers to discuss taking part in a study. This was related to the professionals fear of over burdening patients,32,44,46,50,55,56,71
lack of belief in research,32,50 seeing patients as being
too poorly35,38,46,64 or emotionally distressed38,56 or too
Partner referrals and recruitment
Facilitators: support of lead clinicians/the usefulness of a
trials cooperative. Support of lead clinicians is seen as a
facilitator as this enhanced patient acceptance of the trial
along28,33,39,41,44,46,48 with promoting a research culture in
the recruitment sites.44 The usefulness of a national palliative care clinical trial’s cooperative made up of experts in
the field of palliative care trial research was recognised in
one study. This resource was seen to help improve recruitment as it facilitated team-based support, the sharing and
dissemination of best practices and the opportunity to learn
from each other.46
Working with partners
1005
Dunleavy et al.
Strategy: screening strategies. From the literature, it
would appear identifying and finding potential participants is one of the most significant recruitment challenges in palliative care RCTs with the approaches used
dependent on local resources and systems. A number of
screening strategies are suggested which include ‘active
questioning’ to identify patients with a particular symptom26 or those who are on specific medication rather than
relying purely on clinical notes46 and reviewing clinical lists or notes which may include electronic database
searches if the facilities are available.46,55,72 Other strategies included incorporating the screening process into the
regular palliative care service triage process,17,37 using a
screening algorithm26 and simplifying and minimising
the screening process for clinicians.17
Strategy: financial incentives/recruitment progress
reports. Financial incentives for study site staff were used
in one study to attempt to improve sluggish recruitment
with mixed results across sites.55 Monthly recruitment
progress reports sent to individual sites were used in one
study, and it was felt this encouraged ‘healthy competition
and camaraderie’.55
Strategy: research staff on-site. Having research staff on-site
to provide logistical and practical support to enhance study
recruitment is the strategy discussed most frequently in the
literature.17,26,28,29,36,37,40,46,53–55,60,71 Some authors have seen
this intervention as the one that had the greatest impact on
their recruitment rates.26,40 It can be seen to relieve the excessive burden of recruitment on busy clinical staff,17,26,36,40,53
help address the issue of gatekeeping,28,29,37 support relationship building,26,40,54 help keep a trial visible,71 allow direct
access to participants46 and provide consistency.17
But it is important to note that in some trials, this does
not always appear to be the case, and the issue of gatekeeping remained a problem despite the presence of a research
nurse.35 The issue of research staff not being available at
the ‘right time’ to approach potential participants was
sometimes seen as a problem with patients being discharged or transferred to another department before they
were able to be approached.27
Discussion
Main findings/results of the study
This review has shown that the barriers to recruitment
and the potential strategies that may help to overcome
them described in the literature are largely based on anecdotal evidence. There are likely to be issues to consider
for most studies, such as the need to pay attention to key
and careful messaging, plan for adequate resources to
find your participants, ensuring you have the support of
the lead clinician and gatekeeping by healthcare professionals, but the lack of evidence highlights the need for
more methodological studies to be embedded within trials including nested trials of recruitment strategies.
Using a marketing approach in palliative care could
appear to be controversial, but it could be argued that it actually puts the patient or carer at the centre of the process as it
requires the researcher to focus on ‘the needs, wants, and
preferences of the target audience’ (p. 10).14 Recruitment is
a complex process and needs careful planning before the
study is started. The ‘Social Marketing Mix Framework’
may help researchers better understand the processes underpinning recruitment and influence the design of their recruitment plan and how they implement this plan in practice.14
The framework can help those involved in trials apply general recruitment principles while acknowledging the need to
take trial specific and local circumstances into account. For
example, one of the challenges identified in the literature
was the issue of high refusal rates, and this was not always
related to the patient’s condition. Their refusal sometimes
appeared to be related to their concerns about the ‘product’
which in social marketing terms relates to the intervention
that is being offered in the study. A lack of belief in the intervention or the control, the feeling the intervention was not
needed or having a particular preference for a certain treatment arm were discussed as reasons for refusal. Under the
‘Social Marketing Framework’ ensuring the ‘product’ meets
the needs of the target audience is a key consideration when
designing a study which in practice is reflected in the
increasing requirement for patient and public involvement
to be involved in the study design process.74
The role of healthcare professionals in recruitment to
palliative care RCTs is fundamental, and a plan of a how a
study will work with its partners to meet its recruitment
goals is crucial. ‘Working with Partners’ with its focus on
‘partner education’, ‘partner referrals and recruitment’ and
‘barriers to partnering’ is a key aspect of the marketing
framework applied in this review and is linked to the concepts of ‘Place’ and ‘Promotion’. For example, this refers
to the location where recruitment activity takes place as
well as the way in which the healthcare professional presents the study to the patient.
However, ‘Product’ and ‘Price’ are applied to the patient
and/or carer and not the partner under this framework
which may not fully capture the complexities of recruitment in palliative care. For example, clinicians struggling
to accept the intervention or randomisation and feeling the
emotional costs of approaching a patient or carer at a difficult time in their lives, making it hard for them to balance
the costs of taking part in the study with the potential benefits the study may have for participants.
Strengths and weaknesses/limitations of the
study
To the authors’ knowledge, this is the first review to synthesise the evidence related to the barriers and facilitators
1006
to recruitment to RCTs in palliative care. The search
strategy and approach used was thorough in this review,
however, the authors do not claim to have identified and
reviewed all published palliative care RCTs papers for
reported barriers and facilitators to recruitment. The
review findings are largely based on researcher anecdotal
evidence so should be interpreted with caution. This is,
however, the level of evidence that is currently underpinning our understanding of recruitment issues in palliative
care RCTs.
What this study adds
This review is unique in this field as it uses a theoretical
framework, the ‘Social Marketing Mix Framework’, to
explore the barriers and facilitators to recruitment to RCTs
in palliative care. Using theory in the review process can
help the reviewer and reader assess how applicable and
generalisable the findings of a review can be in practice.
This review builds upon the findings of a recent qualitative
review into gatekeeping in palliative care research and
provides an insight into the some of the factors that may be
at play during the trial recruitment process.13 This review
can help those involved in recruitment identify the factors
they should consider when planning and implementing a
recruitment strategy for any palliative care research study
and not just a RCT. Reviews that focus purely on ‘tested’
recruitment strategies or interventions are important, but
their findings can be complemented by work that adopts a
more qualitative approach as they have the potential to
‘elicit and identify the hidden challenges’ that make up this
important clinical activity.75
Palliative Medicine 32(5)
care research along with the growing recognition of the
importance of patient and public involvement when
designing a study.74
Conclusion
The ‘Social Marketing Mix Framework’ can help guide
researchers when planning and implementing their recruitment strategy, but more methodological research is needed
to help address the issue of poor recruitment to palliative
care RCTs. The findings of this review are applicable to all
palliative care research and not just RCTs.
Acknowledgements
L.D. is the main author of this paper and has produced this paper
as part of her PhD in Health Research at Lancaster University.
C.W. and N.P. are Lesley Dunleavy’s PhD supervisors. They
have provided support throughout the development of this paper
as well as critical review and suggestions for improvement. A.O.
was a visiting research fellow at Lancaster University and acted
as a second reviewer during the assessment of study eligibility,
data extraction and coding.
Data management and sharing
Additional data to support the review has been submitted as supplementary data.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship and/or publication of this
article.
Funding
Implications for research and clinical practice
There is a need for more methodological research focusing
on recruitment to palliative care RCTs. There are clearly
themes mentioned more frequently in the literature that
would suggest they are significant in clinical research but
without the research to explore or address these issues further it is likely palliative care RCTs will continue to struggle to reach their recruitment targets. The benefits of using
qualitative research to address recruitment–related issues
such as patient and recruiter concerns regarding randomisation in the early stages of trial development have been
seen in the field of cancer treatment trials.76 This approach
appears to be increasingly incorporated into the design of
palliative care feasibility RCTs.62,77 Feasibility studies
have the potential ‘to design out’ any issues that may negatively impact on a trial’s recruitment success or demonstrate that a study is in fact not feasible before progressing
to a more costly full-scale RCT. The use of embedded
clinical trials to test recruitment strategies is another
approach that is being developed in the field of trial methodology78 and has the potential to be used within palliative
The author(s) received no financial support for the research,
authorship and/or publication of this article.
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