GERD

Journal of Affective Disorders 172 (2015) 274290
Contents lists available at ScienceDirect
Journal of Affective Disorders

journal homepage: www.elsevier.com/locate/jad
Review
Factors affecting recruitment into depression trials: Systematic review,

meta-synthesis and conceptual framework
Adwoa Hughes-Morley a,n, Bridget Young b, Waquas Waheed a, Nicola Small a, Peter Bower a
a
NIHR School for Primary Care Research, Manchester Academic Health Science Centre, Centre for Primary Care, Institute of Population Health,
The University of Manchester, Manchester, UK
b
MRC North West Hub for Trials Methodology Research, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK
art ic l e i nf o
a b s t r a c t
Article history:
Received 30 May 2014
Received in revised form
1 October 2014
Accepted 3 October 2014
Available online 16 October 2014
Background: Depression is common and clinical trials are crucial for evaluating treatments. Difculties in
recruiting participants into depression trials are well-documented, yet no study has examined the factors
affecting recruitment. This review aims to identify the factors affecting recruitment into depression trials
and to develop a conceptual framework through systematic assessment of published qualitative research.
Methods: Systematic review and meta-synthesis of published qualitative studies. Meta-synthesis involves a
synthesis of themes across a number of qualitative studies to produce ndings that are greater than the
sum of the parts. ASSIA, CINAHL, Embase, Medline and PsychInfo were searched up to April 2013.
Reference lists of included studies, key publications and relevant reviews were also searched. Quality
appraisal adopted the prompts for appraising qualitative research.
Results: 7977 citations were identied, and 15 studies were included. Findings indicate that the decision to
enter a depression trial is made by patients and gatekeepers based on the patient's health state at the time
of being approached to participate; on their attitude towards the research and trial interventions; and on
the extent to which patients become engaged with the trial. Our conceptual framework highlights that the
decision to participate by both the patient and the gatekeeper involves a judgement between risk and
reward.
Limitations: Only English language publications were included in this review.
Conclusions: Findings from this review have implications for the design of interventions to improve
recruitment into depression trials. Such interventions may aim to diminish the perceived risks and increase
the perceived rewards of participation.
& 2014 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-SA license
(http://creativecommons.org/licenses/by-nc-sa/3.0/).
Keywords:
Systematic review
Depression
Patient recruitment
Meta-synthesis
Randomised controlled trials
Conceptual framework
Contents
1.
2.
3.
4.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
2.1.
Systematic literature search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
2.1.1.
Inclusion and exclusion criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
2.2.
Quality appraisal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
2.3.
Literature synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
3.1.
Search results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
3.2.
Quality appraisal outcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
3.3.
Literature synthesis: analysis and results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
3.3.1.
Health state . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
3.3.2.
Attitudes towards research and trial interventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
3.3.3.
Engaging the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
Application of the synthesis to develop a conceptual framework of key factors involved in patients' decision to participate in depression trials 284
Corresponding author. Tel.: 44 161 275 7632; fax: 44 161 275 7600.
E-mail address: [email protected] (A. Hughes-Morley).
http://dx.doi.org/10.1016/j.jad.2014.10.005
0165-0327/& 2014 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-SA license (http://creativecommons.org/licenses/by-nc-sa/3.0/).
A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290
5.
Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.
Summary of key ndings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.
Comparison with existing literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.3.
Research implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.4.
Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Role of funding source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conict of interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acknowledgement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appendix A.
Search strategy Medline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appendix B.
The papers excluded from the meta-synthesis, and reasons for exclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1. Introduction
Depression is a major health problem and is predicted to become
the single leading cause of disease burden worldwide by 2030
(World Health Organization, 2004; World Health Organization,
2013). A signicant number of patients do not fully recover despite
treatment (National Collaborating Centre for Mental Health, 2009;
Torpey and Klein, 2008; Hardeveld et al., 2010). Thus there remains
a signicant need to develop effective interventions for managing
depression.
Whilst clinical trials are the most scientically rigorous way of
comparing alternative treatments, delivery of such trials is limited
in a large part by poor recruitment and retention of research
participants (Tenhave et al., 2003; Sacks et al., 1982; Barton, 2000).
Difculties with recruiting participants into clinical trials are very
common: 45% of publicly funded trials require an extension and 80%
of industry trials do not meet enrolment deadlines (Sully
et al., 2013; Centerwatch, 2009). To our knowledge there have been
no studies establishing the scale of recruitment problems specically
for depression trials, so the exact magnitude of difculties in this area
is unknown. However, there is a general consensus that depression
trials experience particular challenges with recruitment, and many
fail to recruit their proposed sample of participants to target, or
indeed fail altogether (Hunt et al., 2001; Fairhurst and Dowrick, 1996;
Woodford et al., 2011; Rendell and Licht, 2007; Hetherton et al.,
2004; Garnham et al., 2011; Ruddell et al., 2007; Stek et al., 2007;
Katz et al., 2005; Minas et al., 2005; Haberfellner, 2000;
Yastrubetskaya et al., 1997). Other consequences of poor recruitment
include increased costs and effort, reduction in statistical power, and
delays in the generation of evidence and the subsequent adoption of
effective interventions (Halpern et al., 2002; Patel et al., 2003;
Dreke et al., 2003).
Historically, recruiting into trials has commonly been considered an
art rather than a science, whereby the recruitment experience has
been thought to be unique to each trial and each recruiter (Bonvicini,
1998; Baquet et al., 2008; Timmerman, 1996). The importance of
recruitment and retention to research, clinical practice and policy
received relatively little attention (Froelicher and Lorig, 2002). Whilst a
large number of individual interventions to address recruitment
difculties have been reported in the literature, very few of these
interventions have robust evidence of effectiveness, leading to the
conclusion that recruiting for science has not been underpinned by a
science of recruitment (Bower et al., 2009, p. 393). All systematic
reviews undertaken on the topic have called for an urgent need for
systematically evaluated recruitment interventions, particularly those
that are tested in real-world trials (Foy et al., 2003; Watson and
Torgerson, 2006; Woodall et al., 2010; Prescott et al., 1999; Campbell
et al., 2007; Mcdonald et al., 2006; Fletcher et al., 2012; Uybico et al.,
2007; Caldwell et al., 2010; Johnson et al., 2011; Rendell et al., 2007;
Treweek et al., 2013). Furthermore, recruitment is now highlighted as
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the methodological research priority for clinical trials units in the

United Kingdom (Smith et al., 2014).
The MRC Complex Interventions Framework can be adopted to
develop and evaluate recruitment interventions using a multiphased approached (Craig et al., 2008; Tramm et al., 2013). Within
the Framework, evidence synthesis and qualitative research are
important methodologies in intervention development (Peters,
2010). Here, we use qualitative meta-synthesis to identify and
synthesise the evidence base on factors affecting recruitment into
depression trials, to assist in the development of interventions
aimed at improving recruitment into depression trials.
Systematic reviews provide the most reliable research ndings
by applying explicit methods that minimise bias (Higgins and
Green, 2011; Antman et al., 1992; Oxman and Guyatt, 1993).
Systematic reviews of qualitative research aim to apply similar
methodology to the exploration of subjective experiences about
meanings, processes or interventions (Pettigrew and Roberts,
2006). There have been numerous systematic reviews investigating various aspects of recruitment into clinical trials, and recently
two of these reviews have adopted the meta-synthesis approach to
investigate reasons for participating in trials in general; and
willingness of patients of Chinese heritage to participate in trials
(Mccann et al., 2013; Limkakeng et al., 2013). However few have
focused on mental health, and of those, the rst reviewed barriers
to participation in mental health research, focusing on gender,
ethnicity and age (Woodall et al., 2010); the second reported on
the inclusion of Latinos with obsessive compulsive disorder in
clinical trials (Wetterneck et al., 2012); and the third examined
barriers to recruiting ethnic minorities to mental health research
(Brown et al., 2014). None of these mental health reviews adopted
a meta-synthesis approach, nor focused on the specic factors
affecting the recruitment of participants into depression trials.
Our aims in undertaking this review were rstly to systematically identify relevant qualitative studies describing factors
affecting recruitment of participants into depression trials; and
secondly to perform a meta-synthesis to identify common themes
that describe factors affecting recruitment into depression trials, to
develop a conceptual framework of factors inuencing the decision to participate in depression trials.
2. Method
The method we employed was meta-synthesis (Stern and Harris,
1985). Much as meta-analyses for quantitative studies focus on
combining results from different studies with the aim of identifying
patterns among study results, meta-synthesis attempts to integrate
results from a number of different but inter-related qualitative studies
to generate new insights. The process involves both induction and
interpretation. However, whilst meta-analysis typically aggregates data
276
to produce a common measure of effect size, meta-synthesis involves

reconceptualising themes from across a number of qualitative studies
to combine phenomena into a transformed whole (Noblit and Hare,
1988). Numerous published high quality systematic reviews of qualitative studies have applied this method, including meta-syntheses on
clinical trial recruitment (Limkakeng et al., 2013; Mccann et al., 2013)
and depression (Beck, 2002; Khan et al., 2007; Knowles et al., 2014;
Lamb et al., 2012; Gask et al., 2011; Malpass et al., 2009); however to
our knowledge no study to date has addressed both.
Within meta-synthesis the data comprise the main themes
reported in each of the primary studies. These main themes are
synthesised across the studies to develop a conceptual framework
concerning the factors affecting recruitment into depression trials.
Our review and meta-synthesis comprised three stages: systematic literature search; quality appraisal; and synthesis.
2.1. Systematic literature search
This review investigated empirical accounts of factors affecting
the recruitment of patients into depression trials. We considered
any studies (including those using mixed methods) that reported
qualitative empirical ndings, including from gatekeepers/professionals as well as from patients with depression. The search strategy
identied terms corresponding to clinical trial recruitment and
depression (and their variants) (see Appendix A for Medline
search strategy). Electronic bibliographic database searches used a
combination of medical subject headings (MeSH) and free text. Test
searches were conducted and expert advice from specialists in
retrieval was sought to maximise efciency (Centre for Reviews and
Dissemination, 2009). Whilst we aimed to identify qualitative
studies, we did not include a qualitative research lter in the
electronic database searches as our test searches indicated qualitative studies were poorly indexed (Gorecki et al., 2010), whereby a
number of studies known to us were not retrieved when the
qualitative methodological lters were applied. Rather, we read
and reviewed study titles and abstracts to increase the likelihood of
identifying all suitable qualitative studies.
The following databases were searched from inception: ASSIA
(1987 to 8th April 2013), CINAHL (1937 to April 7th 2013), Embase
(1974 to 2013 April 05), Medline (1946 to March Week 4, 2013)
and PsychInfo (1806 to April Week 1 2013). Manual searches of the
reference lists of included studies, key publications and relevant
reviews were also undertaken.
2.1.1. Inclusion and exclusion criteria
Table 1 lists the inclusion and exclusion criteria. Due to limited
resources we only included papers published in the English language.
Unpublished articles, dissertations, non-empirical published articles

and book chapters, and conference abstracts without corresponding
full text articles were excluded. Studies with a majority (more than
50%) of participants under 18 years of age were also excluded, as
paediatric trials can involve specic issues and procedures that are
not present in trials involving adults (Caldwell et al., 2004).
2.2. Quality appraisal

There is lack of consensus about quality assessment in qualitative
research (Mays and Pope, 2000; Dixon-Woods et al., 2004a). In
recognition of this, and arguments that quality in qualitative research
does not arise simply from adherence to recommended procedures
(Barbour, 2001; Chamberlain, 2000), quality appraisal within this
review was therefore adapted from the minimally prescriptive
prompts for appraising qualitative research (Dixon-Woods et al.,
2004b, 2006). The prompts aim to sensitise appraisers to the various
dimensions of articles that require evaluation, and include an assessment of whether the aims and objectives of the research were clearly
stated; whether the research questions are suited to qualitative
methodology; and whether the sampling, data collection and analysis
are clearly described and appropriate to the research question (see
Table 4). Using these criteria, we critically assessed papers while
maintaining a methodologically neutral position, and taking into
account methodological rigour, clarity of reporting, as well as our
assessment of the overall contribution made by the study.
Although quality assessment can sometimes be used to exclude
studies that do not meet certain criteria, this is not standard practice
(Centre for Reviews and Dissemination, 2009). Papers were not
excluded on the basis of quality assessment, but rather we placed
emphasis on contribution, whereby the most relevant and methodologically strong papers were given more weight in the synthesis
(Gough, 2007). The objective was to prioritise studies that appeared
to be relevant, rather than particular study types or papers that
followed particular methodological procedures or standards. This
can be described as prioritising signal (the message of the study,
or likely relevance) over noise (potential methodological weaknesses) (Dixon-Woods et al., 2006; Edwards et al., 2000). Noise in
our review was quantied by a checklist for methodological quality,
and signal by an explicit judgement about the value of the ndings
presented in each study. This has been used effectively in highquality published reviews (Langer et al., 2013; Dixon-Woods et al.,
2006; Marshall et al., 2012; Stack et al., 2012).
One reviewer (AH-M) initially assessed each paper for methodological quality and for contribution. Each included paper was assigned
to one of two predetermined categories, using the coding: KP (Key
Paper which is conceptually rich and methodologically sound. Papers
Table 1
Study inclusion and exclusion criteria, adapted from SPIDER (Cooke et al., 2012).
Inclusion
Exclusion
Studies: Peer reviewed journal articles or conference papers published anytime up to April
Unpublished dissertations, book chapters or papers
2013.
Articles in English language, published in any country
Sample: Patients with depression, professionals including clinicians, as well as researchers etc. Studies with a majority (more than 50%) of participants under 18 years
of age
Phenomenon of interest: Recruitment of research participants
Studies that focus on attrition
No qualitative analysis undertaken or primarily quantitative data
Design: Qualitative studies, or mixed methods studies containing substantial qualitative
reported. Questionnaire data were included in this classication
components that can make a contribution to the meta-synthesis. As an operational
denition, data collected were in the form of semi-structured interviews, focus groups, open
ended evaluation forms involving free text responses, observational eld notes, or reective
journals. Papers should report some form of thematic or inductive analysis
Evaluation: Any type of evaluation/outcome, including patient, clinician or researcher views Reports that focus on the feasibility of delivering interventions in
depression trials, rather than on recruitment
Research type: Qualitative and mixed methods studies that report on factors affecting
Studies of recruitment into depression research studies that are not
recruitment into depression trials
randomised controlled trials
that in our appraisal of contribution were the most relevant) or SAT

(Satisfactory Paper). Where it was unclear about the methodological
quality and contribution of a paper, the paper was reviewed by a
second author (PB), and then discussed with the rst reviewer (PB) to
reach agreement. Any disagreement was resolved in discussion with a
third reviewer (BY).
2.3. Literature synthesis
To undertake the meta-synthesis, articles were read and re-read,
starting with the Key Papers (KP) and continuing through all 15
papers. First and second order constructs were abstracted from the
results and discussion sections of papers into a spreadsheet. Firstorder constructs refer to everyday understandings of the study
phenomena (e.g. as conveyed in direct quotes from participants as
reported in a paper). Second-order constructs are dened as the
authors' interpretations of participants' accounts often expressed as
themes or analytical categories within qualitative studies. Based on
these rst and second order constructs, we developed third order
constructs or interpretations, to generate a conceptual framework
(Britten et al., 2002; Noblit and Hare, 1988).
Two reviewers (AHM, NS) reviewed the spreadsheet independently
and categorised the rst order constructs to identify emerging themes.
Second-order constructs were reviewed to see how they compared
and translated across papers. Review of the constructs also paid
attention to any differences in perspective between patients and
gatekeepers. Reviewers independently sifted the second order constructs, developing new third order constructs to offer new insights
277
and understanding. Discussion with a third, independent reviewer

(PB) then rened these constructs until a consensual understanding
was reached.
Duplicated papers were removed before screening. Titles and
abstracts were screened for relevance by one reviewer (AH-M). 10%
of retrievals were reviewed by a second reviewer (NS). Full-text
retrievals were assessed by two reviewers (AH-M and BY). Where it
was unclear whether to include or exclude a paper, the full text was
obtained and discussed between all authors. Disagreements were
dealt with via discussion.
3. Results
3.1. Search results
The search initially identied 9932 citations, and 15 studies were
eligible for inclusion in the review. The owchart summary of
literature search and outcome is presented in the PRISMA diagram
(Fig. 1) (Moher et al., 2009). Appendix B outlines the studies excluded
at full-text review and reasons for exclusion.
Table 2 summarises and Table 3 details the characteristics of
the 15 included papers (Barnes et al., 2012; Bartlam et al., 2012;
Carey et al., 2001; Cramer et al., 2011; Dowrick et al., 2007;
Fairhurst and Dowrick, 1996; Hetherton et al., 2004; Hinton
et al., 2006; Mason et al., 2007; Mendel et al., 2011; Schroer
et al., 2009; Shellman and Mokel, 2010; Tallon et al., 2011; Van Der
Weele et al., 2012; Chew-Graham et al., 2007).
Fig. 1. Summary of literature search, adapted from PRISMA (Moher, 2009).
278
Table 2
Summary of included studies.
Number of studies (%)
Country:
UK
USA
Netherlands
Multinational
Context:
Primary care
Outpatient psychiatry
Hospital and community
Ethnic minorities/underserved communities only
Older ethnic minority adults
Primary and secondary care
Perspective:
Gatekeepers/providers/staff only
Patients with depression only
Both Gatekeepers/providers/staff and patients
Data collection:
Qualitative interviews only
Mixeda qualitative methods
Focus groups
Free text responses
Analysis method:
Thematic analysis
Framework
Constant comparison
Content analysis
Immersion/crystallisation technique
Inductive
Mixed (thematic analysis, constant comparison, framework approach)
9
4
1
1
(60%)
(27%)
(7%)
(7%)
10
1
1
1
1
1
(67%)
(7%)
(7%)
(7%)
(7%)
(7%)
7 (47%)
6 (40%)
2 (13%)
8
5
1
1
(53%)
(33%)
(7%)
(7%)
5
4
2
1
1
1
1
(33%)
(27%)
(13%)
(7%)
(7%)
(7%)
(7%)
a
Mixed methods combined interviews with the following: questionnaires, conversations, focus groups, open ended evaluation forms,
eld notes, journals and observations.
3.2. Quality appraisal outcome

Table 4 presents the outcome of the quality and contribution
assessment for each of the 15 included papers. Based on overall
contribution and conceptual richness, in addition to satisfying each of
the prompt questions, eight papers out of the 15 included papers
were judged to be Key Papers. Overall therefore, the majority of
included studies were judged to be of generally good quality. Seven
papers were judged to be Satisfactory Papers; compared to the Key
Papers, Satisfactory Papers lacked conceptual richness and made a
lesser contribution to the synthesis, and/or demonstrated limitations
in the reporting of ndings. Common weaknesses within the 15
included studies were mainly around the presentation of ndings,
and included: lack of a clear description of analysis method;
insufcient raw data to support interpretations; and limited contextual information about sampling and participants.
Stigma (including perceived stigma, self-stigma, and double

stigma weakness or vulnerability associated with mental

illness, as well as that associated with severe mental illness or
craziness)
Protecting the vulnerable patient (such as clinician concerns
about capacity of depressed patients to provide valid informed
consent, concerns about welfare of patients as well as patients
being perceived to be too depressed)
Presenting depression trials to patients (including the particular
difculties introducing research in a depression consultation,
clinician skill, condence and experience in introducing the
trial to patients)
Treatment preferences (such as strong patient preferences for
particular trial treatments, or negative views about treatment
options and objections to randomisation)
Views of trial processes and procedures (such as inconvenience
posed by participation).
3.3. Literature synthesis: analysis and results

The four sub-themes around facilitators were
45 emerging themes and analytical categories were initially
identied and furnished with rst and second-order quotes extracted
from individual studies, which we reviewed and consolidated into 11
sub-themes.
Firstly, we categorised these sub-themes into either facilitators to
participation or barriers to participation in depression trials; these
were concepts directly adopted from use in several of the included
papers (Bartlam et al., 2012; Hinton et al., 2006; Mason et al., 2007;
Mendel et al., 2011; Shellman and Mokel, 2010) (Tables 5 and 6).
The seven sub-themes around barriers were
Expression of depression symptoms (which includes presentation, endorsement and impact of depression symptoms)
Risk of trial to mental health (that participation would be

depressing or anxiety provoking)
Access to services to meet mental health need (gaining additional

resources and trial being perceived as offering a service)
Altruism
Marketing (active promotion of trial to patients and gatekeepers)
Trust (in research teams and in referrers, as well as endorsement by valued individuals and organisations).
The second step was to apply a line-of-argument synthesis
based on the themes around barriers and facilitators (Noblit and
Hare, 1988). Line-of-argument synthesis is fundamentally about
inference, and uses both similarities and differences across the
studies to build up a picture, or a whole that makes sense of the
parts. Our reading of the included studies showed consistent
themes but also different perspectives, particularly those between
279
Table 3
Characteristics of included studies.
Reference and setting
Study objectives
1.
To explore patients' reasons for declining Patients responding to an initial invitation

to participate in research involving a
to be contacted about a study of the
talking therapy (n 25)
effectiveness of cognitive behavioural
therapy as a treatment for depression
Barnes et. al. (2012)

United Kingdom
2.
Bartlam et. al. (2012)

Nine countries: the
Czech Republic,
Israel, Italy,
Lithuania, Holland,
Poland, Romania,
Spain and the UK
3. Carey et. al. (2001)
USA
4.
Chew-Graham et. al.

(2007) United
Kingdom
5.
Cramer et. al. (2011)

United Kingdom
Sample
Concern over the inappropriate exclusion

of older people from clinical trials is
longstanding. To investigate the extent of
exclusion of older people in clinical trials,
and to explore the views of those directly
involved
Older people and carers living with

conditions commonly affecting older
people: hypertension, cancer, dementia,
heart failure, stroke and depression
(n 285)
To provide information regarding the

experiences of 45 outpatients who
recently completed their participation in a
trial that was designed to promote
healthier behaviours among adults with a
SPMI
To presents experience of recruiting
patients into the PRIDE trial which was
carried out in one Primary Care Trust
(PCT)
To examine the feasibility and
acceptability of a trial of a group
intervention based on CBT principles for
women with depression in primary care
Outpatients with severe and persistent

mental illness (SPMI) who had
participated in a trial (n 45)
General practice staff, general

practitioners, practice nurses and
community nurses (n 15)
Women aged 3055 years (n 75)
Method of data
collection
Analysis
Context
Questionnaire
and semistructured
telephone
interviews
Focus groups
(n 42)
Thematic analysis Primary care
Constant
comparison
Hospital and
community
Semi-structured
[exit] interviews
Content analysis
Outpatient
psychiatric
clinics
Conversations
and semistructured
interviews
Interviews
Constant
comparison
Primary care
Primary care
Thematic
analysis, constant
comparison
method and
framework
approach
Thematic analysis Primary and
using Framework secondary
care
To ascertain views of potential study

participants of the ethics and pragmatics
of various balanced placebo designs, in
order to inform the design of future
antidepressant drug trials
To evaluate the effectiveness of
7. Fairhurst and
Dowrick (1996) United counselling in the management of minor
psychiatric morbidity in general practice,
Kingdom
and to explore the reasons for difculties
in recruiting patients to such an
evaluation
To describe the study, the problems that
8. Hetherton et. al.
were encountered when GPs agreed to
(2004) United
recruit participants during consultations
Kingdom
and to outline possible solutions to these
problems
9. Hinton et. al. (2006) To examine gender differences in
USA
recruitment, depression presentation, and
depression treatment history in a large
effectiveness trial; and to use qualitative
data to generate hypotheses about
reasons for observed gender differences
10. Mason et. al. (2007) To investigate the perceived barriers
United Kingdom
among GPs towards introducing
participation in trials to patients
presenting with depression during
consultations
11. Mendel et. al. (2011) To evaluate one of a number of
USA
community engagement strategies
employed in the Community Partners in
Care (CPIC) study, the rst randomized
controlled trial of the role of community
engagement in adapting and
implementing evidence-based depression
care
To identify subgroups of patients with
12. Schroer et. al.
depression who could be the focus of
(2009) United
effectiveness trials
Kingdom
GPs, psychiatrists and patients with

depression (n 48)
Focus groups and

in-depth
interviews
General practitioners (n 8)
Semi-structured
telephone
interviews
Inductive
Questionnaire,
qualitative
interview
Referring physicians, depression care

managers, and study recruiters (n 30)
Qualitative
interviews
Semi-structured
interviews

using framework
approach
Administrators, providers, psychologists,

licensed therapists, social workers,
psychiatrists, physicians, registered
nurses, drug treatment counsellors, case
managers (n 187)
Open-ended
evaluation forms,
qualitative
observation eld
notes
Thematic analysis Community

engagement/
Inclusion of
ethnic
minorities in
RCTs
Acupuncture patients, acupuncturists,

physicians (n30)
In-depth
interviews
13. Shellman and

Mokel (2010) USA
Research assistants, senior centre

directors, pastors, church group leaders
(n not reported)
Reective
journals,
participant
observations, and
key informant
interviews
Thematic analysis
using the
framework
approach
Immersion/
crystallisation
technique
6.
Dowrick et. al.

(2007) United
Kingdom
To describe barriers and strengths of a

study testing the effects of reminiscence
on depressive symptoms in communitydwelling older African Americans
Primary care
Primary care
Older adults/
Research with
ethnic
minority
communities
Primary care
280
Table 3 (continued )
Reference and setting
Study objectives
14. Tallon et. al. (2011)

United Kingdom
Cross-sectional
survey involving
free text
responses
To explore limiting and motivating factors Patients with depression offered a coping Interviews
in accepting an offer to join a coping with with depression course (n 23)
depression course, and perceived needs
among persons aged 4/ 75 years who
screened positive for depressive
symptoms in general practice
15. Van Der Weele

et. al. (2012) The
Netherlands
Sample
To investigate patients' views on

participating in a primary care trial
comparing two antidepressant drugs
Method of data
collection
Patients with depression who had

participated in a trial (n 601)
Analysis
Context
Thematic analysis
using framework
approach
Table 4
Quality appraisal using the prompts, adapted from Dixon-Woods et al. (2007).
Source paper
Are the
aims and
objectives
of the
research
clearly
stated?
Are the
research
questions
suited to
qualitative
enquiry?
Are the following appropriate Are claims

to the research question?
supported
by
Sampling Data
Analysis Sampling Data
Analysis
sufcient
collection
collection
evidence?
Are the data,

interpretations
and
conclusions
clearly
integrated?
Rating
Does the
paper make a
useful
contribution?
1.
KP
KP
KP
KP
SAT
SAT
KP
SAT
KP
KP
SAT
SAT
SAT
KP
SAT
Barnes et. al.

(2012)
2. Bartlam et. al.
(2012)
3. Carey et. al.
(2001)
4. Chew-Graham
et. al. (2007)
5. Cramer et. al.
(2011)
6. Dowrick et. al.
(2007)
7. Fairhurst and
Dowrick (1996)
(2004)
9. Hinton et. al.
(2006)
10. Mason et. al.
(2007)
11. Mendel et. al.
(2011)
12. Schroer et. al.
(2009)
13. Shellman (2010)
14. Tallon et. al.
(2011)
15. Van Der Weele
et. al. (2012)
Are the following clearly

described?
KP: Key Paper, to be included in systematic review, SAT: Satisfactory Paper, to be included in systematic review.
patients and gatekeepers. The line-of-argument approach was

utilised to make sense of apparent contradictions in the data and
to integrate the emergent themes and derive new insights. This
synthesis revealed three key constructs which are discussed with
direct quotations extracted from original interviews:
1. Health state
2. Attitudes towards research and trial interventions
3. Engaging the patient.
Table 7 provides examples of rst- and second-order constructs

and third-order synthesised themes. These core themes enabled
us to develop a conceptual framework of factors inuencing the
individual decision to participate in depression trials.
3.3.1. Health state

The decision whether to participate in a depression trialor in the
case of gatekeepers to invite patients to participateis ltered through
consideration around the patient's health state. There were two key
facets of this: rstly the impact of depression on the patient and their
ability to engage with trials, and secondly the potential impact of the
trial on the patient's health statepositive, neutral or negative.
In terms of the impact of depression, the presenting symptoms
of the condition, such as lack of concentration and condence and
low motivation were noted to be barriers to participation: When I
get depressed, everything seems hard on me (Carey et al., 2001). The
relapsing-remitting nature of the disease, as well as the impact of
comorbid conditions could also adversely affect recruitment
(Mason et al., 2007; Barnes et al., 2012; Van Der Weele et al.,
2012; Tallon et al., 2011). Here patients could easily fall into either
281
Table 5
Barriers to participating in depression trials.
Source paper
Expression of depression
symptoms (Presentation,
endorsement and impact
of depression symptoms)
Risk of trial to
mental health
(Fear of
symptom
exacerbation)
1. Barnes et. al. (2012)

2. Bartlam et. al.
(2012)
3. Carey et. al. (2001)
4. Chew-Graham
et. al. (2007)
5. Cramer et. al.
(2011)
6. Dowrick et. al.
(2007)
7. Fairhurst and
Dowrick (1996)
(2004)
9. Hinton et. al.
(2006)
10. Mason et. al.
(2007)
11. Mendel et. al.
(2011)
12. Schroer et. al.
(2009)
13. Shellman and
Mokel (2010)
14. Tallon et. al.
(2011)
15. Van Der Weele
et. al. (2012)
X
X
Stigma
(Perceived,
self, double
stigma)
Protecting the
vulnerable patient
(Concerns about
capacity and welfare
of patients)
Presenting depression
trials to patients
(Difculties introducing
research to patients with
depression)
X
X
X
X
X
X
X
X
Views of trial
processes and
procedure
(Inconvenience
and burden)
X
X
Treatment
preferences (Patient
and clinician
preferences for
particular trial
treatments)
of the too ill or too well categories; both of which meant

enrolment into a trial was less likely. Those who declined trial
participation often reported that they did not feel depressed or
were happy with their situation (Van Der Weele et al., 2012).
Patients were less likely to consider enrolling in depression
trials when they were experiencing remission of symptoms as
they felt a need to protect their the wellness or health state
(Dowrick et al., 2007; Van Der Weele et al., 2012), and patients
voiced concern that participation may lead to deterioration in
health status if they were otherwise coping: If I felt that I'd
reached a stage with my depression that it was no longer a factor in
a) my working life, b) my social life, c) my domestic life, then I
wouldn't [participate], because you're on the straight and narrow and
you don't want anything to demur from that or jeopardise it
(Dowrick et al., 2007).
Core issues arose in terms of the potential impact of the trial on
the patient's health, which were typically viewed in the context of
risk versus rewards in the decision about participation. Depression
trials were perceived with caution by both patients and professionals, with welfare issues a key consideration. For patients, there
was awareness that participating in trials might carry risks,
particularly for those that are older and/or in poor health, and
how participation may affect the individual's ability to cope and
manage their illness: Well, being older and having more diseases
and entering a trial with a drug, you cannot be sure on the body's
reactions (Bartlam et al., 2012).
Nine papers addressed issues from the perspective of gatekeepers and other professionals (general practitioners, other physicians, nurses, acupuncturists etc.) (Chew-Graham et al., 2007;
Hetherton et al., 2004; Dowrick et al., 2007; Fairhurst and Dowrick,
X
X
1996; Hinton et al., 2006; Mason et al., 2007; Mendel et al., 2011;
Schroer et al., 2009; Shellman and Mokel, 2010). Patients with
depression were typically viewed as vulnerable, often leading to
protectiveness on the part of professionals. Here trials were sometimes viewed as an extra demand that would overburden patients
and generate more distress. Clinicians particularly were less likely to
refer patients who were unwell, for fear of further deterioration in
the patient's health: sometimes you're so anxious to get this person
feeling better you, anything you think might jeopardise that or stall it
you're bit disinclined to do (Mason et al., 2007). In contrast to this,
patients reported being more amenable to participation if their
condition was currently impacting negatively on their quality of life;
here a key factor was potential alleviation of symptoms: I decided it
would be helpful if I could improve my health (Carey et al., 2001).
3.3.2. Attitudes towards research and trial interventions

Attitudes towards research and trial interventions were a
theme represented in all but two papers. A key facilitating factor
in patients enrolling in depression trials was trials offering
potential access to services to meet mental health needs. Both
patients and professionals considered trial interventions as a
potential resource to be accessed in order to address patients'
depression treatment needs. This was particularly the case where
there was a lack of local resources. For clinicians, referral into a
depression trial could be an acknowledgement that all else has
failed in terms of the treatment they could provide to their
patients: When I refer patientsit is when I have completely
exhausted my own resources (Fairhurst and Dowrick, 1996).
Depression trials could also provide improved services that were
282
Table 6
Factors serving as facilitators in depression trials.
Source paper
Barnes et. al.

(2012)
2. Bartlam et. al.
(2012)
3. Carey et. al.
(2001)
4. Chew-Graham
et. al. (2007)
5. Cramer et. al.
(2011)
6. Dowrick et. al.
(2007)
7. Fairhurst and
Dowrick (1996)
8. Hetherton
et. al. (2004)
9. Hinton et. al.
(2006)
10. Mason et. al.
(2007)
11. Mendel et. al.
(2011)
12. Schroer et. al.
(2009)
13. Shellman and
Mokel (2010)
14. Tallon et. al.
(2011)
15. Van Der
Weele et. al.
(2012)
Trust (in
Access to services to Altruism Marketing
researchers,
(to both
meet mental health
patients and referrers)
needs (viewing the
gatekeepers)
trial as a resource)
1.
X
X
X
X
X
X
X
X
GPs as inferior and believed that patients would be disappointed

or could not cope if they were randomised to a usual GP care
control group (Hetherton et al., 2004; Schroer and Macpherson,
2009). Support for this came from the patient perspective, who
considered randomisation to the wrong allocation a potential
risk; patients not randomised to the intervention arm often voiced
disappointment: I wasn't in a group. I wanted to be (Carey et al.,
2001). Equipoise was highlighted as a fundamental requirement of
successful RCTs: all treatment arms being perceived as equally
effective or ineffective by both the health professional and the
prospective participant (Fairhurst and Dowrick, 1996). However
this was often difcult to achieve in practice for GPs in the context
of psychological therapy trials as this went against the predominant professional attitude of benign paternalism: Faced with a
patient, in your own mind you've made a therapeutic decision one
way or another: either they need [trial intervention] or they don't
(Fairhurst and Dowrick, 1996).
Altruism, the desire to help others and contribute to further
knowledge and treatment, was discussed in four studies (Cramer
et al., 2011; Carey et al., 2001; Dowrick et al., 2007; Tallon et al.,
2011). Altruism was an important consideration in patients enrolling
into depression trials; however it did not appear to be the sole
consideration for many potential participants. Whilst patients
wanted to help, this willingness to participate appeared to be
enhanced when there was a sense that they were also helping
themselves: I felt that I was being helped yet helping others at the
same time (Tallon et al., 2011). If helping others involved making no
personal gains, or indeed, risking the stability of one's mental
health, then patients with depression were less likely to participate.
local and relevant in the day-to-day management of patients:

Well there's nowhere else to send these patients, so they get
something out of it, as do us GPs who are doing the extra work
(Chew-Graham et al., 2007).
For patients, participating in depression trials could enable
access to otherwise unavailable treatment options. Another motivating factor was a general preference for interventions that did
not involve antidepressant medication, because of perceived disadvantages such a dependence, toxicity, contraindication with
other medication and side effects (Cramer et al., 2011; Schroer
et al., 2009; Bartlam et al., 2012; Tallon et al., 2011). Patients who
previously had experience of the active trial interventions were
also more likely to decline participation, particularly when they
had found it to be a negative experience (Barnes et al., 2012).
Conversely, options for innovative treatments (such as acupuncture) could be appealing (Schroer et al., 2009).
Randomisation was potentially a signicant barrier to the
recruitment of depressed patients (Hetherton et al., 2004; ChewGraham et al., 2007; Fairhurst and Dowrick, 1996; Carey et al.,
2001). For GPs, randomisation was often a difcult procedure in
practice, even though they acknowledged its value. The traditional
responsibility of GPs is the well-being of individual patients, which
is promoted by directing them to the best possible treatment
for their presenting problems. Randomisation presented GPs
with a competing responsibility, specically, to prioritise scientic
advancement from which future patients would benet. Faced
with an ethical dilemma between care of their patients and
research interests, GPs often opted to adhere to their traditional
role and did not risk their patient being randomised to the nondesired arm of the study. Clinician referral to a trial was also often
perceived as a recommendation for the active trial interventions
(Schroer et al., 2009), and some GPs viewed treatment as usual by
3.3.3. Engaging the patient

Engaging the patient focuses on communication and the
relationships between the patient, gatekeepers and trial team, and
includes themes of stigma, the presentation of depression trials to
patients, marketing and trust. Stigma was a theme reported in six
studies (Carey et al., 2001; Hinton et al., 2006; Schroer et al., 2009;
Shellman and Mokel, 2010; Tallon et al., 2011; Van Der Weele et al.,
2012). Depression was reported to be viewed as a highly stigmatised
condition by patients, associated with severe mental illness or
craziness. Patients often viewed depression as a much more severe
mental state than the condition which they were experiencing
themselves, or associated with mental or moral weakness. This
resulted in double stigma, which was a barrier both in terms of
patients accessing care in general, and into depression trials in
particular. The diagnostic label depression was a term that patients
could be fearful of, and which they sought to avoid; clinicians might
in turn de-emphasised the diagnostic label, and avoided the
potential stigma associated with enrolling in a depression trial.
While this was an issue across genders and age groups, older men,
and men of lower socio-economic status were reported to be
particularly reluctant to be diagnosed as depressed.
Five papers discussed challenges in presenting depression trials
to patients (Cramer et al., 2011; Chew-Graham et al., 2007; Hetherton
et al., 2004; Dowrick et al., 2007; Mason et al., 2007). In general,
clinicians often found it difcult to introduce the trial in a depression
consultation, where patients presented as emotionally vulnerable
and distressed. This is linked with the health state theme, and
underscores communication as particularly problematic in this context: i.e. it was difcult to raise research in a clinical consultation, and
where raising the unrelated issue of research may lead to negative
clinical effects, those issues were exacerbated. Raising the issue of
trials was described as a sales pitch by GPs (Mason et al., 2007). To
introduce the trial detracted from focusing on presenting problems
and was felt to be detrimental to patients, and this appears to
undermine GPs' ability and willingness to introduce the research at
283
Table 7
Examples of rst- and second-order constructs and synthesised themes.
First order construct
Second order constructs
There's more shame associated with admitting to Because older men tend not to endorse depressed
symptoms of depression, admitting to failure. mood or sadness, they were often viewed as more
reluctant to accept the diagnosis of depression
(Hinton et. al., 2006)
and the treatment recommendations (Hinton,
2006).
Is this going to do my patient any good, or am I GPs described the presenting symptoms of
just doing it for the study's sake? (Mason et. depression, such as lack of concentration and
condence and low motivation, as barriers to
al., 2007)
patients agreeing to take part in research. Some
patients were characterised as too ill, distressed,
distracted, inward focused and indecisive to be
involved in research and this sometimes
constrained GPs' willingness to introduce the
study to them (Mason, 2007).
The capacity of patients with depression,
I mean, the issue is if a person is really truly
particularly severe or longstanding depression, to
depressed, to what extent is he truly
autonomous? To what extent is he or she in a provide valid informed consent was a cause for
position to make a decision, you know, in terms concern (Dowrick, 2007).
of giving their consent to a trial with all the
informed information that goes with it?
(Dowrick et. al., 2007)
Several GPs saw research as an extra demand that
Well, I thought it's bothersome that it's so far
would overburden patients and generate more
away. That was a reason not to do it the
travelling is still a big nuisance If I had to pay distress (Van Der Weele et. al., 2012).
the taxi myself it would be a bit too much for
me. Taxis are quite expensivethat would be
reimbursed (Van Der Weele et. al., 2012)
Well there's nowhere else to send these patients, The trial was perceived to be local, relevant and
offered an additional service to them in the dayso they get something out of it, as do us GPs
to-day management of a particularly underserved
who are doing the extra work. GP (ChewGraham et. al., 2007)
patient group (Chew-Graham, 2007)
Even those participants who were not
I wasn't in a group. I wanted to be just (for)
experience, like to know what other people go randomized to a group intervention commented
on their desire to be part of one (Carey, 2001).
through and maybe I could learn something
from them. (Carey et. al., 2001)
I guess I wanted to be part of something, to help Patients also noted that participating in the
research allowed them to make a contribution to
out society I just thought it might help
somewhere down the line. (Carey et. al., 2001) the care of other patients, and to contribute to
science through their participation (Carey, 2001).
[The randomization process] is the reason why Although the GPs recognised the value of
they didn't get into the study in the rst place. It randomisation and agreed to participate in the
process, the majority of them found the
stopped it. (Fairhurst and Dowrick, 1996)
procedure difcult in practice. The traditional
responsibility of GPs is the well-being of
individual patients which is promoted by
directing them to the best possible treatment for
their presenting problems. The randomisation
and recruitment procedures presented GPs with a
competing responsibility, specically, to prioritise
scientic advancement from which future
patients would benet (Fairhurst and Dowrick,
1996)
Sometimes I think they're not as forthcoming
Depression's stigma may result not only from its
because of the stigma. They will not say, I feel association with vulnerability or weakness,
sad or I feel depressed. They'll say I have a
but also from its association with severe mental
stomach ache. (Hinton et. al., 2006)
illness or craziness. These are theoretically
separable sources of stigma, and as a result,
patients may be vulnerable to double stigma
and amplication of their suffering (Hinton,
2006)
As the trial was concerned with patients who
To raise the research seemed alien to the
presented with depression or anxiety,
atmosphere of the consultation. (Hetherton
recruitment involved raising the issue of the
et. al., 2004)
research with patients who possibly presented as
emotionally vulnerable or distressed. It seems
that this context undermined GPs' ability to
introduce the issue of research at all (Hetherton,
2008)
It must be said by a physician I visit regularly First amongst those processes that could mitigate
risks to participation was the reliability of the
Then I would like to agree, because my
physician tells me this (Bartlam et. al. 2012) person suggesting inclusion, almost invariably
seen ideally as a physician (Bartlam et. al. 2012)
In my opinion, the issue is that older persons are
not aware of clinical studies and researchers
Sub-theme
Third order construct: Synthesis of main

ndings into an explanatory framework
Expression of
depression
symptoms
Health state
Consideration around the patient's health state
is a key factor for both patients and referring
clinicians.
Risk of trial to
mental health
The diagnosis of depression often lends to

patients being characterised as vulnerable,
often leading to protectiveness on the part of
the treating clinician
Protecting the
vulnerable
patient
Burden
Access to services Attitude towards trial interventions

Here tension is played out between equipoise
to meet mental
and access. Both patients and clinicians see
health needs
depression trials as a potential platform to
Treatment
access valued services. Strictly the trial
preferences
interventions are in equipoise, but in the
context of people seeking services and wanting
access, that is not the case. So the trial is
Altruism
presented as a neutral test, but is not received as
such, because people want support
Randomisation
Stigma
Engaging the patient

Introducing depression trials to patients can be
particularly difcult in the context of patients
presenting as emotionally vulnerable and
distressed, as well as avoiding the stigmatising
label of a mental illness diagnosis
Presenting
depression
trials to
patients
Effective marketing of trials to patients and

clinicians, as well as trust in the integrity of the
trial and trialists promotes willingness to
participate. Trial communication might aim to
enable people to consider whether they are in a
win:win situation in which both they and
others might benet. Stigma negatively affects
recruitment, Depression trials need to
normalise depression, and use neutral, nonstigmatising language in participant
communication
Trust
Marketing
284
Table 7 (continued )
First order construct
Second order constructs
Sub-theme
should make an effort to inform older persons. If

older persons become more aware of the
problem, they will get involved more easily.
(Bartlam et. al., 2012)
The (referral) form was so simple, it was no
hassle to refer on. (Chew-Graham et. al.,
2007)
Making the general public more aware of the

importance of trials was seen as a way of
increasing participation (Bartlam et. al., 2012).
Third order construct: Synthesis of main

ndings into an explanatory framework
It appeared that the simplicity of the intervention Trial processes

concept (attending a group with other stressed
women and being taught skills to cope better)
helped participants and recruiters to understand
and promote the groups (Cramer, 2011).
all: To raise the research seemed alien to the atmosphere of the

consultation (Hetherton et al., 2004). Not only was this alien to the
atmosphere of the consultation, it was also alien to the caring of the
depressed patient as to listen empathically to the patient's problems
and then introducing the research was found to be awkward. The
condence of GPs to introduce depression trials to patients related to
their knowledge of the trial and remembering the trial criteria,
familiarity with the paperwork, the patient's acceptance of the
depression diagnostic label, belief in the purpose and clinical relevance
of the trial, and the acceptability of the interventions (Mason et al.,
2007; Hetherton et al., 2004). More practical and pragmatically, heavy
workloads within GP practices could also result in delays in sending
invitation letters to relevant patients after clinical note searches, or
clinical teams refusing to participate in trials altogether, both of which
negatively impact on recruitment (Cramer et al., 2011; Chew-Graham
et al., 2007; Mason et al., 2007).
Issues around trust were reported in four trials (Bartlam et al.,
2012; Dowrick et al., 2007; Shellman and Mokel, 2010; Van Der
Weele et al., 2012). Trust in the people conducting trials was
reported to be an important factor (Dowrick et al., 2007; Shellman
and Mokel, 2010), as was the opinion and endorsement of valued
individuals and organisations such as ethical review boards, family
and clinicians (Bartlam et al., 2012; Dowrick et al., 2007; Shellman
and Mokel, 2010; Van Der Weele et al., 2012). Having high levels of
trust, particularly in one's doctor, was seen as very important in
inuencing patients' decision as to whether or not to enrol in
depression trials (Bartlam et al., 2012; Van Der Weele et al., 2012).
This was especially crucial if the doctor was the one making the
initial approach about trial participation: If it was my doctor
suggested it: will you try this? I'd say yes, but if anybody else asked
me, I would probably say no (Bartlam et al., 2012). However the
involvement of doctors does not always motivate trial enrolment:
I was visiting my GP and he said You're not suitable for that you
don't need it He just didn't see the need in my case (Van Der Weele
et al., 2012). Mistrust on the other hand was an important factor
in refusal to participate, particularly for older African-Americans
(Shellman and Mokel, 2010). This mistrust expressed itself as
concern about researchers' motives and research conduct, extensive
questioning by gatekeepers and professionals during initial meetings, and refusal to participate.
4. Application of the synthesis to develop a conceptual

framework of key factors involved in patients' decision to
participate in depression trials
to combine ndings across the studies. This allowed us to develop

new insights in the form of a conceptual framework of the key
factors involved in the patient's decision to participate (Fig. 2).
This conceptual framework focuses on the patient and the
gatekeeper and their weighing up of the participation decision. In
reaching the participation decision, the patient and gatekeeper
rely on the third-order constructs of health state, attitudes towards
trial and research interventions and engaging the patient to weigh
up the risks and rewards of the participation decision. According
to our framework, there are two key points at which decisions are
made as to whether or not to participate in a depression trial.
Firstly, the gatekeeper needs to make a decision as to whether or
not to inform the patient about the opportunity to participate in the
trial (i.e. the patient needs to be exposed to the recruitment
method). Secondly, once the patient is exposed to the recruitment
method, they are able to make the decision to accept or decline trial
participation. In both cases, the gatekeeper and patient are faced
with a difcult decision involving risk.
For the gatekeeper, the assessment of risk is centred on negotiating the tension between the difculties introducing depression trials
and the need to protect the vulnerable patient from involvement in
such trials, against accessing new avenues of care to address their
patient's needs; an assessment moderated by their trust in the
research team conducting the depression trial. For the patient, risk
assessment involves balancing rewards (both the personal need to
access treatment and support and feelings of altruism), against the
risks of stigma, of losing out by being randomised to the wrong
intervention arm, or of encountering adverse effects of trial involvement. Here, our line-of-argument synthesis allows us to focus the
weighing up decision on the sub-themes that present with the most
contradictions.
5. Discussion
5.1. Summary of key ndings
Our review highlights that the decision to enter a depression
trial depends on the patient's health state at the time of the
approach; on their attitude towards the interventions being evaluated within the trial; and on the extent to which patients become
engaged with the trial. Our conceptual framework emphasises that
the decision to participate by both the gatekeeper and the patient
involves a judgement between risk and reward.
5.2. Comparison with existing literature
The line-of-argument synthesis entails the construction of an

interpretation (Noblit and Hare, 1988). While the secondary data
suggested that the authors of the included studies were aware of
the tension between concerns about the patient's welfare and
the potential benets of trial participation, the line-of-argument
approach enabled us to explicitly conceptualise these contradictions
As in our review, the previous meta-synthesis of Mccann et al.

(2013) identied that people's health state and health care situation
at the time of being invited to participate in a trial were salient
to participation decisions, and that being able to perceive some
personal benet from trial participation was clearly associated with
285
Fig. 2. Conceptual framework of factors inuencing the decision to participate.
willingness to take part. Personal benet has also been found in

another meta-synthesis to be a primary driver inuencing the
participation of Chinese individuals in trials, particularly for those
who were already unwell and did not have access to any other
effective treatment (Limkakeng et al., 2013).
In contrast to previous meta-syntheses (Mccann et al., 2013;
Limkakeng et al., 2013), our framework more clearly outlines the
tension between risks and reward. Our synthesis also emphasises
the role that gatekeepers play in the recruitment of patients into
depression trials, and that there is often a protective bias in their
predictions of the vulnerabilities of patients with depression
(Roberts and Kim, 2014; Jenkinson et al., 2014).
Our synthesis relates to two published concepts: the therapeutic
misconception (Appelbaum et al., 1982) and injurious misconception
(Snowdon et al., 2007). Therapeutic misconception involves an overstated sense of benet, and occurs when participants demonstrate
difculties in appreciating the distinction between clinical treatment
and research, therefore incorrectly attributing therapeutic intent to
research procedures. Injurious misconception was proposed as a
counterpart to therapeutic misconception, and is a product of a
particularly keen and discomforting sense of distinctions between
care and research and a correspondingly over-stated sense of risk and
threat associated with research. It has been argued that equipoise can
be extremely difcult for mental health trials, particularly for trials of
psychological therapy. This may be due to widespread assumption
that psychological therapy is always helpful to patientsor at least
not harmfuldespite evidence that there can be iatrogenic effects
(Barlow, 2010; Lilienfeld, 2007; Nutt and Sharpe, 2008). Such trials
also cannot be double blind, use a credible placebo, and typically
have strong practitioner effects and patient preference (Parry and
Barkham, 2009).
Given the literature suggesting that people take part in clinical
trials mostly for altruistic reasons, and that deriving personal benet
is a secondary consideration, the strong theme that patients predominantly enrol in depression trials to access to services to meet
mental health needs is noteworthy (Jenkins and Falloweld, 2000;
Andresen et al., 2010; Hussain-Gambles, 2004; Cox, 2000; DixonWoods and Tarrant, 2009; Sharp et al., 2006; Ross et al., 1994;
Criscione et al., 2003; Bevan et al., 2012; Cassileth et al., 1982;
Emanuel and Patterson, 1998; Ross et al., 1999; Loraas, 2009). Whilst
altruism is certainly identied as a distinct theme in this review, it is
overshadowed by the idea of personal benet, which in this context
is the need of patients to address mental health needs. The term
conditional altruism has been coined to describe the general

willingness to help others that may initially incline people to
participate in a trial, but that is unlikely to lead to trial enrolment
in practice unless people also recognise that participation will benet
them personally, or that they will not be disadvantaged from doing
so (Mccann et al., 2010). Strong patient preferences around trial
interventions are common in mental health research (Howard and
Thornicroft, 2006), and such preferences around trial interventions
have been found to affect recruitment (King et al., 2005).
5.3. Research implications
Systematic reviews have consistently highlighted the knowledge gap around effective strategies aimed at those recruiting into
trials (Treweek et al., 2013) and this review is intended to guide
the development and evaluation of interventions to improve
recruitment into depression trials. Our key nding that patients
and gatekeepers weigh up the risks and rewards of the participation decision by taking into account health state, attitudes towards
trial and research interventions and engaging the patient has
methodological implications for innovations in trial design and
delivery. This in turn has the potential to positively impact on the
recruitment of participants.
The emerging concept of patient-centred trials may be adopted
to design trials that potential participants and their clinicians perceive
to be less risky (Mullins et al., 2014; Woolfall et al., 2014). Patientcentred trials have the potential to address the issue of withholding
treatment from patients who are seeking help for their problems, for
example, by encouraging the use of adaptive trials. Such trials are
designed to adjust in a pre-specied manner to changes in clinical
practice and could motivate people and their health care providers to
view clinical trials as more applicable to real-world clinical decisions.
The concept of patient-centred trials may also be applied to evaluate
alternatives to untreated (or treatment as usual) control groups in
depression trials and their effect on recruitment. For example, patient
preference arms can be included in randomisation into depression
trials: here participants with strong preferences are allocated to the
intervention of their choice (Bower et al., 2005). An alternative to
patient preference is waiting list control trials, in which all patients
eventually receive the trial intervention, but are randomised to
receive the intervention immediately, or at a later date (Elliott and
Brown, 2002). A further option could be the explicit use of the
uncertainty principle in depression trials, whereby patients are only
286
entered into trials if clinicians are uncertain which of the trial

treatment would be most appropriate for that particular patient
(Peto and Baigent, 1998, p. 1170).
Patient and public involvement in trials might be better communicated to prospective participants with the aim of reducing
perceptions of risk; specically to normalise depression and
reduce stigma, as well as a form of public endorsement to enhance
trust in those undertaking depression trials (Boote et al., 2014). To
address altruism, trial recruitment communication might aim to
enable people to consider whether they are in a win:win situation
in which both they and others might benet from their participation (Mccann et al., 2010).
Our conceptual framework represents an early effort to develop
an explanatory model. Further qualitative work is required to
understand the process of the decision making and the priority
placed on the themes identied within this review, to better
understand how these factors may be subjected to inuence by
well-designed recruitment interventions. Additional avenues for
further qualitative research may examine recruitment issues in
other populations, for instance in patients with anxiety or with
serious mental illness, as well as in children and members of
minority ethnic groups (Brown et al., 2014; Young et al., 2011). The
studies included in our review were fairly homogeneous in their
methods of data collection, which generally involved qualitative
interviews or focus groups; future research may apply alternative
observational methods, such as audio or video recorded consultations (Salmon et al., 2012).
5.4. Limitations
Our literature searches were systematic and transparent, but
searching for qualitative studies is complex and necessitates further
investigation (Flemming and Briggs, 2007; Tong et al., 2012). Any
systematic review of existing literature will not include factors that
have not been reported in the peer-reviewed literature, and the
synthesis is dependent on the particular studies included. Relevant
publications may have been omitted, particularly as we excluded
studies not published in the English language for resource reasons.
Publication bias also exists in qualitative research (Petticrew et al.,
2008), so our exclusion of grey literature may have resulted in bias.
While we undertook quality appraisal of included studies, due to
resource constrains it was not possible for quality assessment of all
studies to be undertaken independently by two authors; however
when there was a question about the quality of a paper, this was
reviewed by a second author and discussed with the rst author. We
aimed for transparency in all aspects of this review and synthesis;
however the nature of qualitative research means that another
researcher may have obtained different results.
The studies included in this review generally adopted a pragmatic approach and were primarily concerned with increasing the
numbers of patients recruited, rather than the quality of the

recruitment process, which remains poorly delineated (Gross
et al., 2002). There is a debate about the limitations of research
both qualitative and quantitativein identifying clearly, reliably
and consistently barriers and facilitators to trial participation
(Fayter et al., 2007; Salmon et al., 2007). It is possible that there
is some discordance between the factors underlying the motivation to participate in depression trials and participants' accounts of
their decision making. For example, stigma could make participants less willing to reveal motivations.
6. Conclusions
This review highlights a number of barriers and facilitators affecting the recruitment of participants into depression trials, which has
implications for the design of interventions to improve recruitment
into these trials. Findings from the synthesis will enable us to a)
undertake further qualitative work to understand the process and
priority of decision making for patients approached to participate in
depression trials, and b) develop recruitment interventions that can
be evaluated using the MRC Complex Interventions Framework (Craig
et al., 2008).
Ethics
We did not apply for ethics approval as we conducted a systematic
review and meta-synthesis based on published literature.
Role of funding source

The sponsor had no role in the development, design, data collection, analysis or
interpretation.
Conict of interest
All authors declare that we have no competing interests. We have no relationships with companies that might have an interest in the submitted work in the
previous 3 years; their spouses, partners, or children have no nancial relationships
that may be relevant to the submitted work; and have no non-nancial interests
that may be relevant to the submitted work.
Acknowledgement
Adwoa Hughes-Morley is funded by the National Institute for Health Research
(NIHR), through a Doctoral Research Fellowship (Award Reference number: DRF2012-05-128). This article presents independent research funded by the NIHR. The
views expressed are those of the author(s) and not necessarily those of the NHS,
the NIHR or the Department of Health. We are grateful to Dr. Gavin Daker-White,
who read and provided very helpful comments on a draft of this manuscript.
287
Table A1
Search strategy Medline.
Search domains
Search terms used
1.
2.
3.
4.
5.
69,314
55,773
935
10,109
13,1621
Sample
1.
2.
3.
4.
5.
Phenomenon of interest: to increase specicity the recruitment text word terms only identify publications that
refer to the terms more than twice. This was a strategy used in the most recent Cochrane review (Treweek et al.,
2013).
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Design, evaluation, research: these three constructs have been combined to identify ANY research design that
recruits patients with depression.
16. [Leave blank]
16. []
17. 5 and 15
17. 2262
Limits
Depression/
Depressive disorder/
Dysthymic disorder/
Mood disorder/
or/14
Results in Medline
(Search date 5th
April 2013)
Research subject/
Patient participation/
Patient selection/
Enrol?n.ab. /freq 2
recruitn.ab. /freq2
Participatn.ab. /freq 2
Enlistn.ab. /freq2
Informed consent.tw.
Informed consent/
or/614
18. limit 17 to (English

language and humans)
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
4756
16,563
45,870
18,050
29,625
37,227
200
19,713
30,084
17,9749
2097
Appendix A. Search strategy Medline

See Table A1.
Table B1
The papers excluded from the meta-synthesis and reasons for rejection.
Paper
Reasons for rejection
Allen et al. (2009)

Breland-Noble et al.
(2011)
Edge (2008)
This study examined participants' experiences of mindfulness-based cognitive therapy. There was no focus on recruitment issues.
Although this was a qualitative study of recruitment into depression research, the focus is on the recruitment of teenagers, rather than adults.
While this study stated that its focus was around access of women with perinatal depression to services and research, the focus was exclusively
on access to services of depression in general, and there was no focus on recruitment into clinical trials.
Gaudiano et al. (2013) This paper did address treatment expectancies in clinical trials of antidepressants versus psychotherapy for depression. However the data
presented was only of a quantitative nature.
Grant et al. (2009)
While this paper addressed issues to do with motivation, randomisation and withdrawal in a depression RCT, the data presented was not
qualitative in nature.
Kokanovic et al.
This paper looked at the engagement of ethnic minority communities in a qualitative study of help seeking for depression. It was excluded as
(2009)
the focus was not on recruitment into a clinical trial.
Locock and Smith
Included 2 interviewees (out of 42) with depression. Therefore insufciently focused on depression.
(2011)
Loue and Sajatovic
The authors described the challenges encountered in recruiting and retaining a sample of severely mentally ill (including depressed) Mexican
(2008)
and Puerto Rican ethnicity for a study of the context of HIV risk. This study did not present qualitative empirical data.
McFarland et al.
The focus is on patient consent to post-mortem tissue/organ donation for research, not recruitment to an intervention or prevention study.
(2002)
Minas et al. (2005)
This paper explored problems in carrying out a mental health research project in the general practice setting. It was excluded as the research
project was not a clinical trial.
ODonnell et al. (2007) This study used hypothetical vignettes and focus groups to discuss GPs management of patients, including depression. The study discussed
recruitment of GPs in this context, however this did not involve recruitment of patients
Rost et al. (2000)
While this article considered issues of recruitment into a trail of major depression, it did not present qualitative empirical data.
Simpson et al. (2000) Whilst the report of this RCT includes a description of the difculties recruiting participants during the pilot phase of the trial, as well as the
reasons given by GPs for not referring, no qualitative data is presented.
Schroer et al. (2012)
This study focused on discussing the feasibility of the acupuncture intervention rather than recruitment into the trial. (The authors have
published a separate paper focusing on recruitment, which has been included as part of this review.)
Sloane et al. (2006)
The authors sought to develop a model of participant enrolment via a representative cohort of adult primary care patients maintained for use in
multiple projects. The cohort included some depressed patients; however the study did not involve empirical qualitative data.
Steinman et al. (2012) The focus of this paper was on treatment programme implementation after the trial had been completed.
Uebelacker et al.
The authors conducted focus groups with Latinos enroled in a Medicaid health plan in order to ask about the barriers to and facilitators of
(2012)
depression treatment in general as well as barriers to participation in depression telephone care management. There was no emphasis on
clinical trial recruitment.
288
Table B1 (continued )
Paper
Reasons for rejection
van Weel et al. (2006) The authors undertook research methodology workshop to raise awareness and interest in longitudinal research in practice-based research
networks (PBRNs) among family physicians (FP) and researchers. The discussions covered recruitment, and some patients had depression.
However there was no qualitative empirical data presented.
Wasan et al. (2009)
This study used qualitative methodology to address the self-reported reasons for participation in the clinical research of chronic low back pain
and to evaluate those reasons in the context of informed consent and the concept of therapeutic misconception. The study did not focus on
depression.
Whiting et al. (2008) The authors aimed to establish the feasibility of conducting a randomised controlled trial to evaluate the efcacy of acupuncture in the
treatment of mild-to-moderate depression. While they undertook some qualitative interviews with participants, there was very little reporting
of it, with no discussion of themes and no presentation of quotations. Furthermore, the qualitative reporting was presented in terms of the
numbers of participants who mentioned certain factors.
Willison et al. (2009) This paper did not address recruitment, but rather consent for use of personal information for research.
Appendix B. The papers excluded from the meta-synthesis,

and reasons for exclusion.
See Table B1.
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Journal of Affective Disorders 172 (2015) 274290

Contents lists available at ScienceDirect

Journal of Affective Disorders

Factors affecting recruitment into depression trials: Systematic review,

A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290

the methodological research priority for clinical trials units in the

A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290

to produce a common measure of effect size, meta-synthesis involves

Unpublished articles, dissertations, non-empirical published articles

2.2. Quality appraisal

A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290

that in our appraisal of contribution were the most relevant) or SAT

and understanding. Discussion with a third, independent reviewer

Fig. 1. Summary of literature search, adapted from PRISMA (Moher, 2009).

A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290

3.2. Quality appraisal outcome

Stigma (including perceived stigma, self-stigma, and double

stigma weakness or vulnerability associated with mental

3.3. Literature synthesis: analysis and results

Risk of trial to mental health (that participation would be

Access to services to meet mental health need (gaining additional

A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290

To explore patients' reasons for declining Patients responding to an initial invitation

Barnes et. al. (2012)

Bartlam et. al. (2012)

Chew-Graham et. al.

Cramer et. al. (2011)

Concern over the inappropriate exclusion

Older people and carers living with

To provide information regarding the

Outpatients with severe and persistent

General practice staff, general

Thematic analysis Primary care

To ascertain views of potential study

GPs, psychiatrists and patients with

Focus groups and

Thematic analysis Primary care

Referring physicians, depression care

Thematic analysis Primary care

General practitioners (n 41)

Thematic analysis Primary care

Administrators, providers, psychologists,

Thematic analysis Community

Acupuncture patients, acupuncturists,

13. Shellman and

Research assistants, senior centre

Dowrick et. al.

To describe barriers and strengths of a

A. Hughes-Morley et al. / Journal of Affective Disorders 172 (2015) 274290

14. Tallon et. al. (2011)

15. Van Der Weele

To investigate patients' views on

Patients with depression who had

Are the following appropriate Are claims

Are the data,

Barnes et. al.

Are the following clearly

patients and gatekeepers. The line-of-argument approach was

Table 7 provides examples of rst- and second-order constructs