BMJ OpenPR1 2HE, UK Corresponding author: ... Naoimh McMahon, Clinical Practice Research Unit,...
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Activities to support the implementation of complex interventions as part of routine care: a review of the quality
of reporting in cluster randomised controlled trials
Journal: BMJ Open
Manuscript ID: bmjopen-2015-008251
Article Type: Research
Date Submitted by the Author: 20-Mar-2015
Complete List of Authors: McMahon, Naoimh; University of Central Lancashire, Clinical Practice Research Unit Holland, Emma-Joy; University of Central Lancashire, Clinical Practice
Research Unit Miller, Colette; University of Central Lancashire, Clinical Practice Research Unit Patel, Kulsum; University of Central Lancashire, Clinical Practice Research Unit Connell, Louise; University of Central Lancashire, Clinical Practice Research Unit
<b>Primary Subject Heading</b>:
Health services research
Secondary Subject Heading: Health services research
Keywords: n/a, n/a, n/a
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Activities to support the implementation of complex interventions as part
of routine care: a review of the quality of reporting in cluster randomised
controlled trials
Naoimh E McMahon, research physiotherapist, Emma-Joy Holland, senior research assistant,
Colette Miller, research assistant, Kulsum Patel, senior research assistant, Louise A Connell,
NIHR career development fellow
Clinical Practice Research Unit, School of Health, University of Central Lancashire, Preston,
PR1 2HE, UK
Corresponding author:
Naoimh McMahon,
Clinical Practice Research Unit,
School of Health,
University of Central Lancashire
01772 893654
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Abstract
Objective
To review a sample of cluster randomised controlled trials (RCTs) and explore the quality of
reporting of (i) enabling or support activities provided to the staff during the trial, (ii)
strategies used to monitor fidelity throughout the trial and (iii) the actual implementation of
the intervention.
Design
A descriptive review.
Data sources and study selection
We searched MEDLINE for trial reports published between 2008 and 2014 with
combinations of the search terms ‘randomised’, ‘cluster’, ‘trial’ ‘study’, ‘intervention’ and
‘implement*’. We included trials in which healthcare professionals (HCPs) implemented the
intervention being tested as part of routine practice. We excluded trials (i) conducted in non-
health services settings, (ii) where the intervention explicitly aimed to change the behaviours
of the HCPs and (iii) where the trials were ongoing or for which only trial protocols were
available.
Data collection
We developed a data extraction form using the Template for Intervention Description and
Replication (TIDieR checklist). The authors independently extracted data from the included
trials and assessed quality of reporting for each of the checklist components.
Results
We included 63 publications (45 results publications, 18 protocols). 89% of trials reported
using enabling or support activities. How these activities were provided (75.6%, n=34), and
how much was provided (71.1%, n=32), were the most frequently reported components. Less
than 20% (n=8) of the included trials reported that competency checking took place prior to
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implementation and data collection. 58% (n=26) of trials reported collecting measures of
fidelity. 40% (n=18) of the trials reported data from these measures.
Conclusions
Although enabling and support activities are reported in trials, important gaps exist when
assessed using the TIDieR checklist. Better reporting of the supports provided in
effectiveness trials will allow for informed decisions to be made on the financial and resource
implications of wide scale implementation of effective interventions.
Article summary
Strengths and limitations
• Enabling or support activities used to facilitate implementation of interventions in
effectiveness trials should be described in sufficient detail to allow interpretation of
results and future replication
• In this study we used a published checklist, TIDieR (the Template for Intervention
Description and Replication), to comprehensively assess the quality of reporting of
enabling or support activities in included trials
• We did not rate the quality of reporting, as other studies have, but assessed whether or
not authors reported details for each of the items of the TIDieR checklist. The figures
provided here may therefore present a more positive picture than would be the case if
we assessed the extent to which interventions could be replicated from the details
provided
• Our search strategy was designed to identify a sample of effectiveness trials
conducted in health services settings and a large number of eligible published trials
may not have been identified potentially limiting the generalisability of the results
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Introduction
A seminal publication in 2009 by Chalmers and Glasziou identified unusable research reports
as a primary contributor to avoidable waste in research production [1]. Despite
comprehensive guidelines to assist with the reporting of clinical trials, for example the
Consolidated Standards of Reporting Trials (CONSORT) 2010 statement [2] and the
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013
statement [3], gaps in the completeness of reports remain. Trials of complex non-
pharmacological interventions have proved a particular challenge. These interventions have a
number of interacting components and have been found to be adequately described in only
39% of cases [4].
The development and evaluation of complex interventions occurs in distinct phases starting
with initial theory identification and modelling, progressing to pilot and exploratory studies
to test the feasibility of the developed intervention (and the feasibility of conducting a large
scale evaluation), before a final definitive evaluation in the form of a sufficiently powered
randomised controlled trial (RCT) [5]. Such trials have traditionally been designed to be more
explanatory in nature i.e. demonstrating the efficacy of developed interventions under
optimum conditions [6]. However, numerous challenges exist in attempting to translate
research evidence from explanatory trials into real life clinical practice. Most notably lack of
external validity, or generalisability, which has been a long standing criticism of the RCT
methodology [7]. To address this issue, there has been a dramatic increase in the number of
effectiveness trials being carried out which explore the degree of beneficial effect of
interventions when delivered under real world conditions [8]. The findings of these trials, as
one would expect, are of particular interest to clinicians and policy makers but are not
without their methodological limitations [9 10]. As a result of the growing interest in more
pragmatic trial designs, we have also seen increased use of cluster randomisation in health
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services research (i.e. where groups of patients rather than individual patients are
randomised). Cluster randomised designs are particularly appropriate when there is a risk of
contamination across trial groups when trial patients are managed within the same setting
[11].
Trials that aim to demonstrate the effectiveness of an intervention under real world
conditions, will often evaluate the intervention when it is delivered by routine staff as part of
routine care. Successful implementation therefore requires a change in the practices of these
staff [5]. An assessment as to whether or not an intervention has been “successfully”
implemented can be made by measuring implementation fidelity (the degree to which an
intervention is implemented as intended) [12]. To date the practice of reporting fidelity in
published studies has been poor [13-15]. However, more recently the importance of
monitoring and reporting fidelity has been highlighted through the development of influential
frameworks for addressing fidelity [12 16] and reporting guidelines. The ‘CONSORT’
extension for the reporting of RCTs of non-pharmacological treatments [17] and the
Template for Intervention Description and Replication (TIDieR) checklist [18], prompt
authors to report on any planned strategies used to maintain or improve fidelity and to report
actual implementation of the intervention being tested. The TIDieR checklist also prompts
authors to describe “any enabling or support activities” used to assist with the implementation
of the intervention (item 4).
Previous studies exploring the completeness of intervention descriptions in randomised
controlled trials have not differentiated between different trial designs and have not explicitly
assessed the completeness of reporting of enabling or support activities used to assist routine
staff in implementing the interventions being tested [4 19-21]. This is of increasing
importance due to the number of effectiveness trials being conducted and the increasing
emphasis being placed on implementation theory and research to inform the long term
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implementation of effective interventions. In this study we reviewed a sample of cluster
randomised controlled trials in which routine staff implemented the interventions being tested
as part of routine care to explore the quality of reporting of (i) enabling or support activities
provided to the staff during the trial, (ii) strategies used to monitor fidelity throughout the
trial and (iii) the actual implementation of the intervention.
Methods
Search strategy and selection of reports of trials
To identify a sample of trial reports for the review we searched MEDLINE for publications
with combinations of the search terms ‘randomised’, ‘cluster’, ‘trial’ ‘study’, ‘intervention’
and ‘implement*’ in their titles or abstracts. To manage the scope of the review we included
reports of cluster randomised controlled trials published between 2008 and 2014. This date
range was chosen as the Medical Research Council (MRC) guidance on developing and
evaluating complex interventions was published in 2008 [5], a seminal publication which has
influenced the quality of reporting in trials of complex interventions. We included trials in
which healthcare professionals (HCPs) implemented the intervention being tested as part of
their routine practice. We excluded trials (i) conducted in non-health services settings (e.g.
schools, universities), (ii) where the intervention being tested explicitly aimed to change the
behaviours of the HCPs (e.g. behaviour change interventions (BCIs) such as screening tools,
decision aids, audit and feedback) and (iii) if the trials were ongoing or for which only trial
protocols were available.
NM conducted the first round of screening to remove irrelevant trials based on the exclusion
criteria. The authors then independently screened the titles and abstracts of the remaining
trials for inclusion in pairs. Discrepancies were resolved by discussion or by a third party. In
instances where it was not possible to exclude trials based on title and abstract, full text
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versions were obtained and were independently assessed for inclusion by the authors.
Relevant publications related to the included trials (i.e. trial protocols, process evaluations)
were identified where possible by using the trial registration number or by manually
searching for publications where the primary investigator named on the trial registration was
an author.
Data extraction and analysis
A data extraction spreadsheet based on the TIDieR checklist [18] was developed for the purposes
of the review (See Appendix I – Data extraction form and completed example). Data was
extracted on: the rationale for the support or enabling activities, materials and procedures used,
where the activities were delivered, by who, when and how often and if the training was
accredited or competency checked. Any data on tailoring or modifications to the activities was
extracted along with planned strategies to monitor implementation fidelity, and actual
implementation of the intervention during the trial. In pairs the review authors independently
extracted the required information from a third of the trials (NM was part of two pairs). The
extracted data was cross-checked in the pairs and findings were discussed until consensus for
each section was reached and the authors agreed that all potentially relevant information had been
extracted.
Previous studies have rated intervention descriptions as adequate/complete or
inadequate/incomplete [4 20]. Due to the subjective nature of these types of ratings (i.e. there is
not yet consensus as to what information must be reported in what level of detail to constitute an
adequate description of an intervention) it was decided by the study team to assess each section of
the TIDieR checklist as ‘reported’ or ‘not reported’, and where information was reported to
extract examples of more detailed reporting and more typical reporting. All authors independently
assessed the included trials and crosschecking of the assessments was carried out. Microsoft
Excel was used to analyse the data descriptively.
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Results
We identified 630 citations from our initial search. This became 563 when duplicate citations
were removed. Trials that were conducted in a non-health service setting were excluded in
the first round of screening (n=240) and the eligibility criteria applied to the remaining 323
citations. A total of 63 citations were included for data extraction (45 trial results publications
and 18 related protocols). The reasons for exclusion are shown in Table 1. Process evaluation
publications were identified for 3 of the included trials [22-24]. Due to the small number of
process evaluations identified, and the nature of their content, we extracted data from trial
protocols and results publications only. All publications included in data extraction are
provided in Appendix II – Publications included in data extraction.
Table 1: Reasons for exclusion of trials
Reasons n
Testing behaviour change intervention targeting
professional practices of HCPs
155
No access 19
Non-HCP/mixed HCP and non-HCP 19
Non-health services setting 7
Not relevant 16
Ongoing/no published results 35
Intervention not delivered by routine staff (e.g.
delivered by research team)
19
Unclear who delivered the intervention 8
Total 278
Description of included trials
The trials included in the review span 22 countries. The country with the most included trials
was the Netherlands (n=7), followed by Australia (n=5), Spain (n=5) and the UK (n=5). The
trials results publications came from 33 different journals including the BMJ (n=5), PLoS
One (n=4) and the Lancet (n=3). The topics most frequently addressed were type 2 diabetes
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(n=5), asthma (n=4), cardiovascular disease, hypertension and stroke (n=4) and maternal and
child health (n=4). Just over half of the trials were conducted in primary care settings (n=23).
The interventions were primarily lifestyle/self-management interventions (n=22). The
healthcare professions implementing the interventions in the trials were nurses (n=12),
general practitioners (n=10), pharmacists (n=4), intensive care unit staff (n=2), community
teams (n=2), dieticians (n=1), hospital doctors (n=1) and allied health professions (n=1).
Mixed professions or multidisciplinary teams were responsible for implementing the
intervention in 12 of the trials.
Quality of reporting of enabling or support activities
40 of the 45 trials (88.8%) made reference to some form of enabling or support activities
conducted during the trial. Of the five trials that did not describe any enabling or support
activities, three of these were evaluating infection control interventions in hospital settings.
The number of trials providing information on each of the items of the TIDieR checklist, as
applied to enabling or support activities, is shown in Table 2. How activities were provided,
and how much, were the most frequently reported items (75.5% and 71.1% of trials
respectively). Reporting of the rationale for the chosen activities, any tailoring or
modifications of the activities and measures of planned and actual activities carried out
during the trial were the least frequently reported. Examples of reporting, and variation across
trials for the individual components are provided in Table 3.
Table 2: Number of trials reporting components of enabling or support activities
Components of enabling or support
activities
Reported
% n
Why 6.7 3
Who provided 51.1 23
What materials 55.6 25
Where 20 9
When 46.7 21
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How 75.6 34
How much 71.1 32
Tailoring 2.2 1
Modifications 2.2 1
Measure of fidelity for activities 2.2 1
Actual activities delivered 2.2 1
Competency checking 17.8 8
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Table 3: Examples of reporting, and variation across trials for the individual components
TIDieR
Checklist
Items
More detailed reports More typical reports
Why The development and evaluation of the training intervention have
taken place prior to this trial, and details of the theoretical
background and content have been published elsewhere. The planned
approach to training combines evidence-based approaches to
changing professional behaviour with approaches to ‘normalise’
those behaviours in current practice. [25 26]
The small-group format during the training sessions (a trainer, an
adolescent actor as a simulated patient and 4 participating
physicians) allowed direct observation, feedback and suggestions by
co-participants to monitor and improve adherence to the brief
intervention. [27]
The intervention components were selected
based on a review of the literature of
evidence-based strategies for integrating
smoking cessation into primary care settings.
[28]
Who provided The education is delivered by a Diabetes Specialist Nurse, Dietitian
and Doctor all of whom have undergone training in delivery of the
DAFNE curriculum. [29 30]
The training sessions were designed by 2 of us (D.M.H. and A.M.,
both family physicians trained in adolescent health; A.M. is also a
trainer in motivational interviewing). [27]
Before the start of the study, registered
dietitians had the opportunity to gain
experience with the intervention protocol
under supervision by the project team. [31
32]
Intervention site nursing and social work SBI
providers learned to deliver MI during a 1-
day workshop delivered by the study trainer
(CD). [33]
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What materials A desktop resource was provided with a flow chart illustrating the
elements of counselling and general communication strategies. To
prompt counselling, a summary sheet of smoking-related
characteristics (e.g., cigarettes smoked per day, degree of nicotine
dependence, and stage of change to stop smoking) was generated by
practice assistants based on each patient’s questionnaire and given to
the practitioner. The summary sheet fitted the structure of the desktop
resource to guide the proper selection of counselling elements
adequate for each patient. Additionally, the summary sheet, which
was intended to be stored in the patient’s records, served as a
reminder for the follow-up intervention which was focused on
changes compared to the initial intervention. In addition to
interactive learning methods, video demonstrations with subtitles
identifying the counselling elements and techniques were used for
the practitioner training. [34]
Several aids have been developed to facilitate the use of the SCPD:
1. The SCPD screening tool. The questions for the screening a
caregiver's sense of competence and depressive symptoms are printed
on a handy plasticized pocket card.
2. The SCPD manual. The manual consists of the items to be
discussed during the training sessions (i.e., background information
and methods), and some supporting literature has been added.
3. The starter package and action list. Several forms have been
developed for the requested data. The starter package contains the
forms that professionals need to gather these data. The action list
contains 60 possible intervening and supportive actions that
The instructors were trained and provided
with all the material needed for the theoretical
and practical parts of the thematic meetings.
Also, they were paid for the time needed for
the training, for the actual meetings and for
making the telephone calls. [37 38]
Materials and resources were made available
as hard copy, online and on CDs, to provide
flexible learning opportunities. [39 40]
A training manual was written by the research
team and provided to all nurses. [41]
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professionals might undertake as a result of the screening. They are
divided into nine categories: intake, diagnostics, psychoeducation,
psychosocial care, medical care, how to hand over care, legal care,
case management, and crisis management. [35 36]
Details of the individual sessions that comprise the DAFNE course
are available on the DAFNE Collaborative website and all resource
literature is available to DAFNE graduates via the DAFNE Online
website. [29 30]
Where No examples were identified of more detailed reports on
location/setting for enabling or support activities. This item of the
TIDieR checklist prompts authors to describe the type(s) of
location(s) where the intervention occurred, including any necessary
infrastructure or relevant features
Training consisted of a distance learning
package (6 hours; reading, audit of patients,
four interactive group teleconference
sessions) and two one-hour interactive
practice visits delivered by an academic GP.
[42 43]
First, the team visited NH units before
crossing over to the intervention condition,
explained the program and delivered three
tailored packages to psychologists,
physicians, and nursing staff including unit
managers and activity therapists. [44]
When This training was conducted as pre-trial workshops (HS), during
which pharmacists were instructed about the key pamphlet messages
to reinforce and were advised about the necessity of delivering these
messages strictly in accordance with the pamphlet content.
Pharmacists were encouraged to request clarification and feedback in
All nurses had previously received training in
provision of HBV vaccinations. [41]
Before and during the intervention period the
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regards to delivery of the messages at the time of these workshops
and throughout the trial if/as required. [45]
The on-site workshop was followed over the next 6 months by four
trainer-led 30-minute telephone coaching sessions during which MI
skills were practised and subsequently boosted with written feedback
via e-mail. Following the 6-month training period, intervention site
SBI providers delivered bedside SBI to injured patients. [33]
GP and the pharmacist are offered support by
training, education and a web based
community of practice with a helpdesk on
pharmacotherapy. [46 47]
How Intervention site nursing and social work SBI providers learned to
deliver MI during a 1-day workshop delivered by the study trainer
(CD). The workshop training targeted a 20–30-minute MI that could
be delivered at bedside to injured in-patients by the full spectrum of
trauma center providers (e.g. social work and nursing providers). The
workshop emphasized MI skill development and the importance of
spending adequate time conducting interventions by the bedside with
injured in-patients. The on-site workshop was followed over the next
6 months by four trainer-led 30-minute telephone coaching sessions
during which MI skills were practised and subsequently boosted with
written feedback via e-mail. [33]
The Healthy Relationships Training programme. Training consisted
of a distance learning package (6 hours; reading, audit of patients,
four interactive group teleconference sessions) and two one-hour
interactive practice visits delivered by an academic GP (including
one visit with a simulated patient who role-played different readiness
to change scenarios). [42 43]
Several meetings about the aspects and basic
principles of the intervention protocol took
place (i.e. the screening procedure, self-
management principles, client centeredness,
motivational interviewing, interdisciplinary
collaboration, assessment tools, parts of the
toolbox and referrals). [31 32]
The professionals were provided with a two-
hour specific training on how to apply and
use the brief assessment form regarding
asthma-like symptoms and ETS exposure. [48
49]
All nurses in all groups participated in a 4-h
training session on how to establish a
treatment contract with hypertensive patients
or patients with diabetes. [50]
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Practices assigned to the MC intervention group received a multi-
component intervention program to support delivery of the 5As
strategies comprising four elements: (1) outreach facilitation visits;
(2) training; (3) real time provider prompts and patient tools; and (4)
audit and performance feedback. [28]
How much An initial 15 hours of telephone coaching training over two days, and
further support and training was provided to individual nurses after
assessment of their progress. [51 52]
The process of becoming a DAFNE centre involves 43 h of training
for a DAFNE doctor and 105 h of training for each of the (at least 2)
DAFNE educators. [29 30]
The training to teach professionals to use the Systematic Care
Program for Dementia consists of three sessions of 2 hours each. [35
36]
Physicians received 24-hour training on the
study protocol, counseling, and prescription
of physical activity. [53]
All therapists in both groups received 1½
days of training and continuing expert
consultation throughout the study. [54]
All nurses were supported with meetings
every third month during the intervention. [37
38]
Tailoring No examples were identified of more detailed reports on tailoring of
enabling or support activities. This item of the TIDieR checklist
prompts authors to describe if the intervention was planned to be
personalised, titrated or adapted, then describe what, why, when,
and how
First, the team visited NH units before
crossing over to the intervention condition,
explained the program and delivered three
tailored packages to psychologists,
physicians, and nursing staff including unit
managers and activity therapists. [44]
Modifications No examples were identified of more detailed reports on
modifications to the enabling or support activities during the course
of the trial. This item of the TIDieR checklist prompts authors to
Ensuring that training was acceptable at step
3 required considerable compromise in
restricting the length and content of training
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describe if the intervention was modified during the course of the
study, describe the changes (what, why, when, and how)
to match the time that practices were willing
to devote. [25 26]
Measure of
planned
support
activities
No examples were identified of more detailed reports on planned
measures of enabling or support activities provided. This item of the
TIDieR checklist prompts authors to describe if adherence or fidelity
was assessed, and if so to describe how and by whom, and if any
strategies were used to maintain or improve fidelity
Evaluations of teaching sessions: facilitators
evaluate the extent of the planned content of
each teaching session by completing a
standardized evaluation form. This ensures
the consistency of the program delivery at
each site. [55 56]
Actual support
activities
No examples were identified of more detailed reports on actual
enabling or support activities delivered. This item of the TIDieR
checklist prompts authors to describe the extent to which the
intervention (i.e. the enabling or support activities in this case) was
delivered as planned
All implementation strategies were provided
to almost all new staff members except for
new caregivers, who mostly did not follow a
new depression course but were supervised
by the unit managers. [44]
Competency
checking
The readiness of GPs to manage intimate partner abuse is assessed
before and after the training using PREMIS, a validated
questionnaire assessing knowledge, attitude and behaviours of
doctors with regard to intimate partner violence. [42 43]
Evaluation of the translation of knowledge and skills into practice
was built into the course, in the form of a MAWE reflective diary
(used to facilitate learning, but also as research data). / Before
recruiting trial participants, nurses were required to give the
researcher a verbal or written example of practicing each component
of the intervention. They then made a self-assessment of confidence
and competence to practice MAWE before recruiting into the trial.
This took a period of time ranging from one to four months per
nurse. [57]
The audit was based on an inquiry of the
trained nurses proving their knowledge from
training module, nonparticipating observation
of administration of SCION program, and
additional comparison of nursing records with
study documentation for 10% of all included
patients. [58]
Participating pharmacists underwent training
and subsequent assessment of knowledge and
skills. Pharmacists were required to
demonstrate a defined standard of
competence. [39 40]
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Quality of reporting of strategies used to monitor fidelity throughout the trial
and actual implementation of the intervention.
Just over half of the included trials (n=26) reported using a measure of fidelity to
assess the extent to which healthcare professionals delivered the intervention as
intended within the trial. The most frequently reported strategies included notes audits
(n=11), rating of random samples of audio recorded sessions (n=5), self-reported
measures of implementation (from healthcare professionals and study participants)
(n=3) and observation of practice (n=2). Data from these measures was reported in
40% (n=18) of the trials.
Discussion
Statement of principal findings
Almost all of the trials (89%) included in this review reported that enabling or support
activities were used to facilitate implementation of the intervention being tested.
However, large discrepancies were identified in the quality of reporting of the
components of these activities. Authors most frequently reported how enabling or
support activities were provided, and how much was provided, but details related to
who provided, where, when and the underpinning rationale for the content and
delivery of the activities were often omitted. Less than 20% of the included trials
reported that competency checking took place prior to implementation and data
collection. Although, 58% of the included trials reported using specific fidelity
measures to assess the extent to which the healthcare professionals had implemented
the intervention during the trial, data from these measures was only reported in 40%
of the trials.
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Strengths and weaknesses of the study
A strength of this study is the use of the published TIDieR checklist (the Template for
Intervention Description and Replication) to assess the quality of reporting of the
included trials [18]. TIDieR has been developed by Hoffmann and colleagues as an
extension to Item 5 of the CONSORT Statement and aims to guide authors in
describing interventions in a level of detail to allow for future replication. Although
the primary purpose of the TIDieR checklist is to assist in the describing of
interventions being tested, item 4 (what procedures) outlines that some interventions,
particularly complex ones, might require additional activities to enable or support the
intervention to occur, and these should also be described. We would argue, and have
demonstrated here, that these activities are interventions in themselves and therefore
can be reported as per the individual items of the TIDieR checklist.
A limitation of this review may be the included trials and the way in which they were
identified. Although a systematic process was used to identify effectiveness cluster
randomised controlled trials, a large number of published trials will not have been
identified by our search (for example due to the time period or search terms used).
The results of our review therefore may not be generalisable. However, it is also
unknown whether a larger sample would have influenced the overall results of the
study.
When attempting to identify secondary publications for the included trials it became
evident that authors do not always include the trial registration numbers. Despite best
efforts to ensure that all relevant publications were identified this is a limitation of the
study. It is also probable that details of the support activities omitted from the
protocol and trial results publications may be reported elsewhere. However, there is
an argument to be made that although secondary publications, such as process
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evaluations, provide a valuable insight into the trial, the primary publications should
provide some details on any efforts made to maximise implementation during the trial
and also whether or not the intervention was actually implemented as intended to
allow readers to interpret the outcome data presented.
As previously mentioned, similar trials [4 19-21] have not only looked at whether or
not details have been reported but have also made a judgement as to whether the
details provided were sufficient to merit replication. In this review we opted to assess
whether or not authors provided details on the items of the TIDieR checklist and
provide supporting examples. This may also be a limitation of the review as the
figures provided here without doubt present a more positive picture than would be the
case if we assessed the extent to which interventions could be replicated from the
details provided.
Meaning of the study
Despite improvements in the quality of reporting of clinical research in recent years,
complex trial designs, and interventions, have resulted in trial reports leaving readers
with many questions unanswered. In this review we have focused in particular on the
reporting of enabling and support activities and implementation fidelity within trials,
as this is important information for both interpreting the research implications but also
for clinicians wanting guidance on how to implement interventions in their practice.
We have shown that although these activities are reported in trials, there exist
important gaps when assessed using the TIDieR checklist. Implementation science is
a growing field of research, with much interest in how we can best translate
interventions shown to be effective in research into day-to-day clinical practice. In
order to progress this field of implementation research it is important that authors
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describe the rationale for their implementation activities, and the components of these
activities to contribute to the growing evidence-base.
Unanswered questions and future research
Effectiveness cluster randomised trials of complex non-pharmacological interventions
pose numerous challenges in their design, implementation and reporting. However,
there is a growing appreciation for the nuanced and iterative processes that occur
when introducing a new intervention into routine clinical practice and the role of
contextual and personal factors [59]. There is a need for more transparent reporting
about what is happening in trials to make informed decisions about the feasibility and
effectiveness of interventions, along with their likely financial and resource
implications. There is also a need to establish consensus about the level of detail that
should be reported for such large scale trials to ensure that what is reported is
meaningful and useful for patients, the public, clinicians and researchers.
Competing interests
All authors have completed the Unified Competing Interest form at
www.icmje.org/coi_disclosure.pdf (available on request from the corresponding
author) and declare that LC is supported by an NIHR Career Development Fellowship
which also funds NM; the authors have no relationships with other organisations that
might have an interest in the submitted work in the previous 3 years; their spouses,
partners, or children have no financial relationships that may be relevant to the
submitted work; and they have no non-financial interests that may be relevant to the
submitted work.
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Copyright
The Corresponding Author has the right to grant on behalf of all authors and does
grant on behalf of all authors, a worldwide licence to the Publishers and its licensees
in perpetuity, in all forms, formats and media to i) publish, reproduce, distribute,
display and store the Contribution, ii) translate the Contribution into other languages,
create adaptations, reprints, include within collections and create summaries, extracts
and/or, abstracts of the Contribution and convert or allow conversion into any format
including without limitation audio, iii) create any other derivative work(s) based in
whole or part on the on the Contribution, iv) to exploit all subsidiary rights that
currently exist or as may exist in the future in the Contribution, v) the inclusion of
electronic links from the Contribution to third party material where-ever it may be
located; and, vi) licence any third party to do any or all of the above.
Contributors
NM and LC were responsible for study conception and for conducting the original
search. All authors contributed to i) screening studies for inclusion, ii) developing,
piloting and refining the data extraction form and iii) completing data extraction. NM
was responsible for compiling the first draft of the manuscript. All authors were
involved in preparing the final manuscript for submission. NM and LC are the
guarantors. All authors had full access to all of the data in the study and take
responsibility for the integrity of the data and the accuracy of the data analysis.
Transparency declaration
NM affirms that the manuscript is an honest, accurate, and transparent account of the
study being reported; that no important aspects of the study have been omitted; and
that any discrepancies from the study as planned have been explained.
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Ethical approval
Not required.
Funding
LC is supported by an NIHR Career Development Fellowship that also funds NM.
This article presents independent research funded by the National Institute for Health
Research (NIHR). The views expressed are those of the authors and not necessarily
those of the NHS, the NIHR or the Department of Health.
Role of study sponsors
Not applicable.
Data sharing
Further details of included trials and data extraction is available on request from
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Appendices
I. Data extraction form and completed example
Data extraction form
First author of trial results
publication
Blackberry
Publication Title Effectiveness of general practice based, practice
nurse led telephone coaching on glycaemic control of
type 2 diabetes: the Patient Engagement and
Coaching for Health (PEACH) pragmatic cluster
randomised controlled trial.
Trial Acronym PEACH
Trial Registration ISRCTN50662837
Journal Citation Blackberry ID, Furler JS, Best JD, Chondros P, Vale
M, Walker C, et al. Effectiveness of general practice
based, practice nurse led telephone coaching on
glycaemic control of type 2 diabetes: the Patient
Engagement and Coaching for Health (PEACH)
pragmatic cluster randomised controlled trial. BMJ.
2013;347:f5272.
Journal BMJ
Year 2013
Study Design Cluster randomised controlled trial
Publication type Trial results
Other relevant trial
publications
PROTOCOL: Young D, Furler J, Vale M, Walker C,
Segal L, Dunning P, et al. Patient Engagement and
Coaching for Health: The PEACH study--a cluster
randomised controlled trial using the telephone to
coach people with type 2 diabetes to engage with
their GPs to improve diabetes care: a study protocol.
BMC Fam Pract. 2007;8:20.
Topic Type 2 Diabetes
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Aim To evaluate the effectiveness of goal focused
telephone coaching by practice nurses in improving
glycaemic control in patients with type 2 diabetes in
Australia.
Name/type of the
intervention
Patient Engagement and Coaching for Health
intervention (PEACH). (self-management)
HCPs implementing the
intervention
Nurses
Setting General practices
Enabling or support activities
Made reference to enabling
or support activities
Yes
Rationale for the activities Not described
Who provided The research team provides on-site assistance to the
PN in their first two baseline interviews and
questionnaire administration to ensure quality of data
collection.
What materials Practices were reimbursed for their nurses’ time
spent on the PEACH study, including for patient
recruitment, data collection, and delivery of the
intervention.
Where On-site assistance
When Unclear
How Each practice nurse from practices assigned to the
intervention group completed a two day training
programme in telephone coaching. / The research
team provided support to practice nurses during the
intervention period, including one visit to the
practice, monthly telephone calls, and a group
meeting, where all intervention practice nurses could
share their experience and learning from conducting
telephone coaching.
How much An initial 15 hours of telephone coaching training
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over two days, and further support and training was
provided to individual nurses after assessment of
their progress.
Tailoring None described
Modifications None described
Planned measures of fidelity
to the support activities (e.g. monitoring attendance at training
sessions)
Not described
Actual implementation of
support activities (e.g. had to increase number of sessions to
accommodate staff turnover)
Not described
Competency checking in
advance of implementation
/accreditation
None described
Fidelity of implementation of intervention being tested
Measure of fidelity used The "Head Coach" (MV) monitors the first telephone
coaching and random subsequent telephone
coaching.
Actual implementation of the
intervention
The intensity and fidelity of the intervention was
compromised so that the intended dose of the
intervention was not delivered to a high proportion of
patients and in many cases the key element of a focus
on medication intensification through negotiation
with the treating general practitioners was not
achieved. Intervention fidelity also seems to have
been compromised. Content analysis of calls showed
many consultations did not explicitly address
medication intensification, an important part of the
coaching programme.
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II. Publications included in data extraction
First author/year of
trial results publication
Trial registration
number Trial publications included in data extraction
1 Adachi 2013 UMIN000004049
• Adachi M, Yamaoka K, Watanabe M, et al. Effects of lifestyle education
program for type 2 diabetes patients in clinics: study design of a cluster
randomized trial. BMC Public Health 2010;10:742.
• Adachi M, Yamaoka K, Watanabe M, et al. Effects of lifestyle education
program for type 2 diabetes patients in clinics: a cluster randomized
controlled trial. BMC Public Health 2013;13:467.
2 Armour 2013 None identified
• Armour CL, Reddel HK, LeMay KS, et al. Feasibility and effectiveness of
an evidence-based asthma service in Australian community pharmacies: a
pragmatic cluster randomized trial. J Asthma 2013;50:302-9.
3 Blackberry 2013 ISRCTN50662837
• Young D, Furler J, Vale M, et al. Patient Engagement and Coaching for
Health: The PEACH study--a cluster randomised controlled trial using the
telephone to coach people with type 2 diabetes to engage with their GPs to
improve diabetes care: a study protocol. BMC Fam Pract 2007;8:20.
• Blackberry ID, Furler JS, Best JD, et al. Effectiveness of general practice
based, practice nurse led telephone coaching on glycaemic control of type
2 diabetes: the Patient Engagement and Coaching for Health (PEACH)
pragmatic cluster randomised controlled trial. BMJ 2013;347:f5272.
4 Cabezas 2011 NCT00125905
• Cabezas C, Martin C, Granollers S, et al. Effectiveness of a stepped
primary care smoking cessation intervention (ISTAPS study): design of a
cluster randomised trial. BMC Public Health 2009;9:48.
• Cabezas C, Advani M, Puente D, Rodriguez-Blanco T, Martin C, Group
IS. Effectiveness of a stepped primary care smoking cessation intervention:
cluster randomized clinical trial (ISTAPS study). Addiction
2011;106:1696-706.
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- 31 -
5 Chao 2014 None identified
• Chao YH, Usher K, Buettner PG, Holmes C. Cluster randomised
controlled trial: educational self-care intervention with older Taiwanese
patients with type 2 diabetes mellitus--impact on blood glucose levels and
diabetic complications. Collegian 2014;21:43-51.
6 Deales 2014 ACTRN12611000813987
• Deales A, Fratini M, Romano S, et al. Care manager to control
cardiovascular risk factors in primary care: the Raffaello cluster
randomized trial. Nutr Metab Cardiovasc Dis 2014;24:563-71.
7 Derde 2014 NCT00976638
• Derde LP, Cooper BS, Goossens H, et al. Interventions to reduce
colonisation and transmission of antimicrobial-resistant bacteria in
intensive care units: an interrupted time series study and cluster
randomised trial.[Erratum appears in Lancet Infect Dis. 2014
Jan;14(1):11]. Lancet Infect Dis 2014;14:31-9.
8 Dinneen 2013 ISRCTN79759174
• Dinneen SF, MC OH, Byrne M, et al. The Irish DAFNE study protocol: a
cluster randomised trial of group versus individual follow-up after
structured education for type 1 diabetes. Trials 2009;10:88.
• Dinneen SF, O'Hara MC, Byrne M, et al. Group follow-up compared to
individual clinic visits after structured education for type 1 diabetes: a
cluster randomised controlled trial. Diabetes Res Clin Pract 2013;100:29-
38.
9 Garcia-Cardenas 2013 NCT01085474
• Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, Martinez-Martinez F,
Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma
control. A cluster randomised trial. Respir Med 2013;107:1346-55.
10 Grandes 2009 NCT00131079
• Grandes G, Sanchez A, Sanchez-Pinilla RO, et al. Effectiveness of
physical activity advice and prescription by physicians in routine primary
care: a cluster randomized trial. Arch Intern Med 2009;169:694-701.
11 Hafkamp-de Groen 2014 ISRCTN15790308
• Hafkamp-de Groen E, Mohangoo AD, de Jongste JC, et al. Early detection
and counselling intervention of asthma symptoms in preschool children:
study design of a cluster randomised controlled trial. BMC Public Health
2010;10:555.
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• Hafkamp-de Groen E, van der Valk RJ, Mohangoo AD, et al. Evaluation of
systematic assessment of asthma-like symptoms and tobacco smoke
exposure in early childhood by well-child professionals: A randomised
trial. PLoS One 2014;9:e90982.
12 Haller 2014 ACTRN12608000432314
• Haller DM, Meynard A, Lefebvre D, Ukoumunne OC, Narring F, Broers
B. Effectiveness of training family physicians to deliver a brief
intervention to address excessive substance use among young patients: a
cluster randomized controlled trial. CMAJ 2014;186:E263-72.
13 Hegarty 2010 ACTRN12608000032358
• Hegarty KL, Gunn JM, O'Doherty LJ, et al. Women's evaluation of abuse
and violence care in general practice: a cluster randomised controlled trial
(weave). BMC Public Health 2010;10:2.
• Hegarty K, O'Doherty L, Taft A, et al. Screening and counselling in the
primary care setting for women who have experienced intimate partner
violence (WEAVE): a cluster randomised controlled trial. Lancet
2013;382:249-58.
14 Hoddinott 2009 ISRCTN44857041
• Hoddinott P, Britten J, Prescott GJ, Tappin D, Ludbrook A, Godden DJ.
Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant
and breastfeeding mothers in primary care: cluster randomised controlled
trial. BMJ 2009;338:a3026.
15 Hopkinson 2010 None identified
• Hopkinson JB, Fenlon DR, Okamoto I, et al. The deliverability,
acceptability, and perceived effect of the Macmillan approach to weight
loss and eating difficulties: a phase II, cluster-randomized, exploratory trial
of a psychosocial intervention for weight- and eating-related distress in
people with advanced cancer. J Pain Symptom Manage 2010;40:684-95.
16 Jahn 2009 None identified
• Jahn P, Renz P, Stukenkemper J, et al. Reduction of chemotherapy-induced
anorexia, nausea, and emesis through a structured nursing intervention: a
cluster-randomized multicenter trial. Support Care Cancer 2009;17:1543-
52.
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17 Kennedy 2013 ISRCTN90940049
• Bower P, Kennedy A, Reeves D, et al. A cluster randomised controlled
trial of the clinical and cost-effectiveness of a 'whole systems' model of
self-management support for the management of long- term conditions in
primary care: trial protocol. Implement Sci 2012;7:7.
• Kennedy A, Bower P, Reeves D, et al. Implementation of self management
support for long term conditions in routine primary care settings: cluster
randomised controlled trial. BMJ 2013;346:f2882.
18 Labhardt 2011 NCT00744458
• Labhardt ND, Balo JR, Ndam M, Manga E, Stoll B. Improved retention
rates with low-cost interventions in hypertension and diabetes management
in a rural African environment of nurse-led care: a cluster-randomised trial.
Trop Med Int Health 2011;16:1276-84.
19 Law 2011 None identified
• Law MC, Darrah J, Pollock N, et al. Focus on function: a cluster,
randomized controlled trial comparing child- versus context-focused
intervention for young children with cerebral palsy. Dev Med Child Neurol
2011;53:621-9.
20 Leendertse 2013 NTR 2647
• Leendertse AJ, de Koning FH, Goudswaard AN, et al. Preventing hospital
admissions by reviewing medication (PHARM) in primary care: design of
the cluster randomised, controlled, multi-centre PHARM-study. BMC
Health Serv Res 2011;11:4.
• Leendertse AJ, de Koning GH, Goudswaard AN, et al. Preventing hospital
admissions by reviewing medication (PHARM) in primary care: an open
controlled study in an elderly population. J Clin Pharm Ther 2013;38:379-
87.
21 Leonhardt 2008 None identified
• Leonhardt C, Keller S, Chenot JF, et al. TTM-based motivational
counselling does not increase physical activity of low back pain patients in
a primary care setting--A cluster-randomized controlled trial. Patient Educ
Couns 2008;70:50-60.
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22 Leontjevas 2013 NTR1477
• Gerritsen DL, Smalbrugge M, Teerenstra S, et al. Act In case of
Depression: the evaluation of a care program to improve the detection and
treatment of depression in nursing homes. Study Protocol. BMC Psychiatry
2011;11:91.
• Leontjevas R, Gerritsen DL, Smalbrugge M, Teerenstra S, Vernooij-
Dassen MJ, Koopmans RT. A structural multidisciplinary approach to
depression management in nursing-home residents: a multicentre, stepped-
wedge cluster-randomised trial. Lancet 2013;381:2255-64.
23 Luoto 2011 ISRCTN33885819
• Luoto RM, Kinnunen TI, Aittasalo M, et al. Prevention of gestational
diabetes: design of a cluster-randomized controlled trial and one-year
follow-up. BMC Pregnancy Childbirth 2010;10:39.
• Luoto R, Kinnunen TI, Aittasalo M, et al. Primary prevention of
gestational diabetes mellitus and large-for-gestational-age newborns by
lifestyle counseling: a cluster-randomized controlled trial. PLoS Med
2011;8:e1001036.
24 Magoma 2013 ACTRN12609000268246
• Magoma M, Requejo J, Campbell O, Cousens S, Merialdi M, Filippi V.
The effectiveness of birth plans in increasing use of skilled care at delivery
and postnatal care in rural Tanzania: a cluster randomised trial. Trop Med
Int Health 2013;18:435-43.
25 Metzelthin 2013 ISRCTN31954692
• Metzelthin SF, van Rossum E, de Witte LP, Hendriks MR, Kempen GI.
The reduction of disability in community-dwelling frail older people:
design of a two-arm cluster randomized controlled trial. BMC Public
Health 2010;10:511.
• Metzelthin SF, van Rossum E, de Witte LP, et al. Effectiveness of
interdisciplinary primary care approach to reduce disability in community
dwelling frail older people: cluster randomised controlled trial. BMJ
2013;347:f5264.
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26 Meyer 2012 NCT00679861
• Meyer C, Ulbricht S, Gross B, et al. Adoption, reach and effectiveness of
computer-based, practitioner delivered and combined smoking
interventions in general medical practices: a three-arm cluster randomized
trial. Drug Alcohol Depend 2012;121:124-32.
27 Morrell 2009 ISRCTN92195776
• Morrell CJ, Slade P, Warner R, et al. Clinical effectiveness of health visitor
training in psychologically informed approaches for depression in postnatal
women: pragmatic cluster randomised trial in primary care. BMJ
2009;338:a3045.
• Morrell CJ, Warner R, Slade P, et al. Psychological interventions for
postnatal depression: cluster randomised trial and economic evaluation.
The PoNDER trial. Health Technol Assess 2009;13:iii-iv, xi-xiii, 1-153.
28 Nokela 2010 None identified
• Nokela M, Arnlind MH, Ehrs PO, Krakau I, Forslund L, Jonsson EW. The
influence of structured information and monitoring on the outcome of
asthma treatment in primary care: a cluster randomized study. Respiration
2010;79:388-94.
29 Papadakis 2013 NCT00799279
• Papadakis S, McDonald PW, Pipe AL, Letherdale ST, Reid RD, Brown
KS. Effectiveness of telephone-based follow-up support delivered in
combination with a multi-component smoking cessation intervention in
family practice: a cluster-randomized trial. Prev Med 2013;56:390-7.
30 Pladevall 2010 ISRCTN35208258
• Pladevall M, Brotons C, Gabriel R, et al. Multicenter cluster-randomized
trial of a multifactorial intervention to improve antihypertensive
medication adherence and blood pressure control among patients at high
cardiovascular risk (the COM99 study). Circulation 2010;122:1183-91.
31 Pope 2008 None identified
• Pope DS, Deluca AN, Kali P, et al. A cluster-randomized trial of provider-
initiated (opt-out) HIV counseling and testing of tuberculosis patients in
South Africa. J Acquir Immune Defic Syndr 2008;48:190-5.
32 Quinn 2011 None identified
• Quinn CC, Gruber-Baldini AL, Shardell M, et al. Mobile diabetes
intervention study: testing a personalized treatment/behavioral
communication intervention for blood glucose control. Contemp Clin
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Trials 2009;30:334-46.
• Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini
AL. Cluster-randomized trial of a mobile phone personalized behavioral
intervention for blood glucose control. Diabetes Care 2011;34:1934-42.
33 Rat 2014 NCT01610531
• Rat C, Quereux G, Riviere C, et al. Targeted melanoma prevention
intervention: a cluster randomized controlled trial. Ann Fam Med
2014;12:21-8.
34 Roisin 2014 NCT00846105
• Roisin S, Laurent C, Denis O, et al. Impact of rapid molecular screening at
hospital admission on nosocomial transmission of methicillin-resistant
staphylococcus aureus: cluster randomised trial. PLoS One 2014;9:e96310.
35 Septimus 2014 None identified
• Septimus EJ, Hayden MK, Kleinman K, et al. Does chlorhexidine bathing
in adult intensive care units reduce blood culture contamination? A
pragmatic cluster-randomized trial. Infect Control Hosp Epidemiol 2014;35
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36 Slater 2013 ACTRN12611000053921
• Slater H, Briggs AM, Watkins K, Chua J, Smith AJ. Translating evidence
for low back pain management into a consumer-focussed resource for use
in community pharmacies: a cluster-randomised controlled trial. PLoS One
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37 Sonnichsen 2010 ISRCTN27414162
• Sonnichsen AC, Rinnerberger A, Url MG, et al. Effectiveness of the
Austrian disease-management-programme for type 2 diabetes: study
protocol of a cluster-randomized controlled trial. Trials 2008;9:38.
• Sonnichsen AC, Winkler H, Flamm M, et al. The effectiveness of the
Austrian disease management programme for type 2 diabetes: a cluster-
randomised controlled trial. BMC Fam Pract 2010;11:86.
38 Spijker 2011 NCT00147693
• Spijker A, Verhey F, Graff M, et al. Systematic care for caregivers of
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• Spijker A, Wollersheim H, Teerenstra S, et al. Systematic care for
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39 Stewart 2014 ACTRN12609000705280
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43 Weaver 2014 ISRCTN72794493
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Lancet 2014;384:153-63.
44 Wolfe 2010 ISRCTN10730637
• Wolfe CD, Redfern J, Rudd AG, Grieve AP, Heuschmann PU, McKevitt
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45 Zatzick 2014 NCT00607620
• Zatzick D, Donovan DM, Jurkovich G, et al. Disseminating alcohol
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Activities to support the implementation of complex interventions as part of routine care: a review of the quality
of reporting in cluster randomised controlled trials
Journal: BMJ Open
Manuscript ID bmjopen-2015-008251.R1
Article Type: Research
Date Submitted by the Author: 21-Aug-2015
Complete List of Authors: McMahon, Naoimh; University of Central Lancashire, Clinical Practice Research Unit Holland, Emma-Joy; University of Central Lancashire, Clinical Practice
Research Unit Miller, Colette; University of Central Lancashire, Clinical Practice Research Unit Patel, Kulsum; University of Central Lancashire, Clinical Practice Research Unit Connell, Louise; University of Central Lancashire, Clinical Practice Research Unit
<b>Primary Subject Heading</b>:
Health services research
Secondary Subject Heading: Health services research
Keywords: n/a, n/a, n/a
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BMJ Open on S
eptember 17, 2020 by guest. P
rotected by copyright.http://bm
jopen.bmj.com
/B
MJ O
pen: first published as 10.1136/bmjopen-2015-008251 on 9 O
ctober 2015. Dow
nloaded from
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Activities to support the implementation of complex interventions as part
of routine care: a review of the quality of reporting in cluster randomised
controlled trials
Naoimh E McMahon, research physiotherapist, Emma-Joy Holland, senior research assistant,
Colette Miller, senior research assistant, Kulsum Patel, senior research assistant, Louise A
Connell, NIHR career development fellow
Clinical Practice Research Unit, College of Health and Wellbeing, University of Central
Lancashire, Preston, PR1 2HE, UK
Corresponding author:
Naoimh McMahon,
Clinical Practice Research Unit,
College of Health and Wellbeing,
University of Central Lancashire
01772 893654
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Abstract
Objective
To review a sample of cluster randomised controlled trials and explore the quality of
reporting of (i) enabling or support activities provided to the staff during the trial, (ii)
strategies used to monitor fidelity throughout the trial and (iii) the extent to which the
intervention being tested was delivered as planned.
Design
A descriptive review.
Data sources and study selection
We searched MEDLINE for trial reports published between 2008 and 2014 with
combinations of the search terms ‘randomised’, ‘cluster’, ‘trial’, ‘study’, ‘intervention’ and
‘implement*’. We included trials in which healthcare professionals (HCPs) implemented the
intervention being tested as part of routine practice. We excluded trials (i) conducted in non-
health services settings, (ii) where the intervention explicitly aimed to change the behaviours
of the HCPs and (iii) where the trials were ongoing or for which only trial protocols were
available.
Data collection
We developed a data extraction form using the Template for Intervention Description and
Replication (TIDieR checklist). Review authors independently extracted data from the
included trials and assessed quality of reporting for individual items.
Results
We included 70 publications (45 results publications, 25 related publications). 89% of trials
reported using enabling or support activities. How these activities were provided (75.6%,
n=34), and how much was provided (73.3%, n=33), were the most frequently reported items.
Less than 20% (n=8) of the included trials reported that competency checking occurred prior
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to implementation and data collection. 64% (n=29) of trials reported collecting measures of
implementation. 44% (n=20) of trials reported data from these measures.
Conclusions
Although enabling and support activities are reported in trials, important gaps exist when
assessed using an established checklist. Better reporting of the supports provided in
effectiveness trials will allow for informed decisions to be made about financial and resource
implications for wide scale implementation of effective interventions.
Strengths and limitations
• Enabling or support activities used to facilitate implementation of interventions in
effectiveness trials should be described in sufficient detail to allow interpretation of
results and future replication
• In this study we used a published checklist, TIDieR (the Template for Intervention
Description and Replication), to comprehensively assess the quality of reporting of
enabling or support activities in cluster randomised trials
• We did not rate the quality of reporting, as other studies have, but assessed whether or
not authors reported details for items of the TIDieR checklist. The figures provided
here may therefore present a more positive picture than would be the case if we
assessed the extent to which interventions could be replicated from the details
provided
• Our search strategy was designed to identify a sample of effectiveness trials
conducted in health services settings and a large number of eligible published trials
may not have been identified potentially limiting the generalisability of the results
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Introduction
A seminal publication in 2009 by Chalmers and Glasziou identified unusable research reports
as a primary contributor to avoidable waste in research production [1]. Despite
comprehensive guidelines to assist with the reporting of clinical trials, for example the
Consolidated Standards of Reporting Trials (CONSORT) 2010 statement [2] and the
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013
statement [3], gaps in the completeness of reports remain. Trials of complex non-
pharmacological interventions have proved a particular challenge. Complex interventions are
those with numerous interacting components and have been found to be adequately described
in only 39% of trials [4] .
Randomised controlled trials (RCTs) have traditionally been designed to demonstrate the
efficacy of complex interventions under optimum conditions [5]. However, numerous
challenges exist in attempting to translate research evidence from efficacy trials into real life
clinical practice. Most notably the lack of external validity, or generalisability, which has
been a long standing criticism of the RCT methodology [6]. To address this issue, there has
been a dramatic increase in the number of effectiveness trials being conducted which explore
the degree of beneficial effect of interventions when delivered under real world conditions
[7]. RCTs are not considered to be either efficacy or effectiveness trials but can have
characteristics of both and thus are said to sit on a continuum [8].
As a result of the growing interest in more pragmatic trial designs, we have also seen an
increase in the use of cluster randomisation in health services research (i.e. where groups of
patients, rather than individual patients, are randomised). Cluster randomised designs are
particularly appropriate when there is a risk of contamination across trial groups when trial
patients are managed within the same setting [9]. Pragmatic cluster randomised trials will
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usually evaluate interventions when they are delivered by routinely employed healthcare
professionals. Successful implementation therefore requires a change in the practices of these
professionals [10]. The ‘CONSORT’ extension for the reporting of RCTs of non-
pharmacological treatments [11] and the Template for Intervention Description and
Replication (TIDieR) checklist [12], prompt authors to report on any activities that are used
to enable or support professionals to implement the interventions being tested and to report
actual implementation of the intervention. These enabling or support activities can be
considered to be interventions in themselves and therefore merit equal description in trial
reports.
Previous studies exploring the completeness of intervention descriptions in clinical trials have
not differentiated between different trial designs and have not explicitly assessed the
completeness of reporting of enabling or support activities used to assist professionals in
implementing the interventions being tested [4, 13-15]. In this study we reviewed a sample of
cluster randomised controlled trials, in which healthcare professionals employed to routinely
deliver care were responsible for implementing the interventions being tested. We explored
the quality of reporting of (i) enabling or support activities provided during the trial, (ii)
strategies used to monitor fidelity throughout the trial and (iii) the extent to which the
intervention was delivered as planned.
Methods
Search strategy and selection of reports of trials
To identify a sample of trial reports for the review we searched MEDLINE for publications
with combinations of the search terms ‘randomised’, ‘cluster’, ‘trial’ ‘study’, ‘intervention’
and ‘implement*’ in their titles or abstracts (Supplementary file 1). To manage the scope of
the review we included reports of cluster randomised controlled trials published between
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2008 and 2014. This date range was chosen as the Medical Research Council (MRC)
guidance on developing and evaluating complex interventions was published in 2008 [10], a
seminal publication which has influenced the quality of reporting in trials of complex
interventions. We included trials, accessible online and published in English, in which
healthcare professionals (HCPs) implemented the intervention being tested as part of their
routine practice. We excluded trials (i) conducted in non-health services settings (e.g.
schools, universities), (ii) where the intervention being tested explicitly aimed to change the
behaviours of the HCPs (e.g. behaviour change interventions (BCIs) such as screening tools,
decision aids, audit and feedback) and (iii) if the trials were ongoing or for which only trial
protocols were available. In instances where the intervention being tested serviced a dual
purpose of impacting on patient outcomes and also changing the behaviours of healthcare
professionals to implement best practice we made decisions on a case by case bases. Trials
were included in which healthcare professionals were responsible for implementing defined
actions or components of the interventions being tested. Where it was not possible to identify
defined actions or components of the interventions to be implemented these trials were
excluded.
NM conducted the first round of screening to remove irrelevant trials based on the exclusion
criteria. In pairs, all authors independently screened the titles and abstracts of the remaining
trials for inclusion. Discrepancies were resolved by discussion or by a third party. In
instances where it was not possible to exclude trials based on title and abstract, full text
versions were obtained and were assessed for inclusion by the authors in the same way.
Relevant publications related to the included trials (i.e. trial protocols, process evaluations)
were identified where possible by using the trial registration number or by manually
searching for publications where the primary investigator named on the trial registration was
an author.
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Data extraction and analysis
A data extraction form, based on the TIDieR checklist [12], was developed for the purposes of
the review. All of the TIDieR items were applied to enabling and support activities. Data on
fidelity was extracted at two levels (i) fidelity of implementation of the enabling and support
activities and (ii) fidelity of implementation of the intervention being tested. Throughout data
extraction we made minor iterative changes to the way in which the items of the TIDieR checklist
were organised to facilitate ease of use. For example, we reordered some of the items to fit with
how they most often appeared in publications, and we separated “when” and “how much”. Some
additional information which is highlighted in the TIDieR checklist publication was coded as a
separate item as it was reported in a number of trials (i.e. competency checking is discussed under
“who provided” in the original TIDieR publication and we extracted this as a stand-alone item).
The final data extraction form is provided in Supplementary file 2. Data were extracted on: the
rationale for the support or enabling activities, materials and procedures used, where the activities
were delivered, by who, when and how often and if the training was accredited or competency
checked. Data on tailoring or modifications to the activities were extracted along with planned
strategies to monitor implementation fidelity, and actual implementation of the intervention
during the trial. Three pairs of authors independently extracted data from 15 trials each where one
author (NM) was a member of two pairs. Extracted data were cross-checked in the pairs and
findings were discussed until consensus for each section was reached and the authors agreed that
all potentially relevant information had been extracted.
Previous studies have rated intervention descriptions as adequate/complete or
inadequate/incomplete [4, 14]. Due to the subjective nature of these types of ratings (i.e. there is
not yet consensus as to what information must be reported in what level of detail to constitute an
adequate description of an intervention) it was decided by the study team to assess each section of
the TIDieR checklist as ‘reported’ or ‘not reported’, and where information was reported to
extract examples of more detailed reporting and more typical reporting. Items were assessed as
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“not reported” if there was no mention of that item at all in the trial publications. Where authors
made any reference to an item it was assessed as “reported”. A limitation of this approach to
assessment is that it may overstate the quality of reporting in included studies. All authors
independently reviewed the extracted data for each trial and made an assessment for each item
extracted. Examples of variation in reporting were also highlighted by each of the review authors
at this stage. Crosschecking of the assessments was carried out by the lead author. Microsoft
Excel was used to analyse the data descriptively.
Results
We identified 630 citations from our initial search. This became 563 when duplicate citations
were removed. Trials that were conducted in a non-health service setting were excluded in
the first round of screening (n=240) and the eligibility criteria applied to the remaining 323
citations. A total of 70 citations were included for data extraction (45 trial results publications
and 25 related publications). Where available we used trial registration numbers to identify
publications that may have been relevant for data extraction. We identified trial registration
numbers for 35 of the 45 included trials. Known trial registration numbers were used to
search PubMed identifying protocols and trial results publications for 26 of the included
trials. The remaining publications could not be retrieved using the trial registration number
alone. Identification of related publications through trial registration number search was not
always successful but searching using a combination of author name, trial name and
keywords identified 7 additional process evaluation publications. For the 35 trials with
registration numbers, 16 registrations had no records of publications, 6 had a results
publication but no protocol, 12 had both the protocol and results publications and one was not
in English. Related publications for the 9 trials where registration numbers were not
identified were retrieved through additional manual searching. In all but one of the related
publications there was an obvious link to the original trial i.e. the trial was named or cited in
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the publication. One potentially related publication was not included as it was not possible to
link the content to the original trial [16]. A flow diagram of studies through the review is
provided in Figure 1. Citations excluded as “not relevant” were secondary trial publications
(e.g. cost-effectiveness publications), trials where the healthcare professionals employed to
deliver routine care did not take an active role in implementing an intervention (e.g. system
wide quality improvement) and trials where healthcare professionals were recipients of an
education or training intervention (e.g. train-the-trainer initiative). All publications included
in data extraction are provided in Supplementary file 3.
<Insert Figure 1. PRISMA flow diagram about here>
Characteristics of included trials
The trials included in the review span 22 countries. The country with the most included trials
was the Netherlands (n=7), followed by Australia (n=5), Spain (n=5) and the UK (n=5). The
trial results publications came from 33 different journals including the BMJ (n=5), PLoS One
(n=4) and the Lancet (n=3). The conditions most frequently studied were type 2 diabetes
(n=5), asthma (n=4), cardiovascular disease, hypertension and stroke (n=4) and maternal and
child health (n=4). Over half of the trials were conducted in primary care settings (n=23) and
primarily evaluated lifestyle/self-management interventions (n=22). Nurses were responsible
for implementing the intervention in 12 trials, general practitioners in 10 of the trials and
pharmacists in four. Further details on the characteristics of the included studies are provided
in Supplementary file 4).
Quality of reporting of enabling or support activities
40 of the 45 trials (88.8%) made reference to some form of enabling or support activities
conducted during the trial. Of the five trials that did not describe any enabling or support
activities, three of these were evaluating infection control interventions in hospital settings.
The number of trials providing information on each of the items of the TIDieR checklist,
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adapted for enabling or support activities, is shown in Table 1. How activities were provided,
and how much, were the most frequently reported items (75.6% and 73.3% of trials
respectively). Reporting of the rationale for the chosen activities, any tailoring or
modifications of the activities and measures of planned and actual activities carried out
during the trial (e.g. attendance at training sessions) were the least frequently reported.
Table 1: Number of trials reporting components of enabling or support activities
Components of enabling or support activities Reported
% n
Why 11.1 5
Who provided 53.3 24
What materials 57.8 26
Where 22.2 10
When 51.1 23
How 75.6 34
How much 73.3 33
Tailoring 4.4 2
Modifications 4.4 2
Measure of fidelity 2.2 1
Actual activities delivered 6.7 3
Competency checking 17.8 8
Quality of reporting of strategies used to monitor fidelity throughout the trial and the
extent to which the intervention was delivered as planned
Over half of the included trials (n=29) reported monitoring the extent to which healthcare
professionals delivered the intervention as planned within the trial. The ways in which
fidelity was most frequently monitored included notes audits (n=12), rating of random
samples of audio recorded sessions (n=5), self-reported measures of implementation (from
healthcare professionals and study participants) (n=4) and observation of practice (n=2). Of
the trials that reported collecting measures of fidelity, data from these measures was reported
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in in 44.4% (n=20) of the trials. Examples of reporting, and variation across trials for the
individual items are provided in Supplementary file 5.
Discussion
Statement of principal findings
Almost all of the trials (89%) included in this review reported that enabling or support
activities were used to facilitate implementation of the intervention being tested. However,
large discrepancies were identified in the quality of reporting of the components of these
activities. Authors most frequently reported how enabling or support activities were provided,
and how much was provided, but details related to who provided, where, when and the
underpinning rationale for the content and delivery of the activities were often omitted. Less
than 20% of the included trials reported that competency checking took place prior to
implementation and data collection. Although, 29 trials reported using specific fidelity
measures to assess the extent to which the healthcare professionals had implemented the
intervention as planned during the trial, data from these measures was not reported in nine
instances.
Strengths and weaknesses of the study
A strength of this study is the use of the published TIDieR checklist (the Template for
Intervention Description and Replication) to assess the quality of reporting of the included
trials [12]. TIDieR has been developed by Hoffmann and colleagues as an extension to Item 5
of the CONSORT Statement and aims to guide authors in describing interventions in a level
of detail to allow for future replication. Although the primary purpose of the TIDieR
checklist is to assist in the describing of interventions being tested, a number of items in
TIDieR discuss how some interventions, particularly complex ones, might require additional
activities to enable or support the intervention to occur, and these should also be described.
We would argue, and have demonstrated here, that these activities are interventions in
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themselves and therefore can be reported with the same level of detail and attention afforded
to the intervention under investigation.
A limitation of this review may be the included trials and the way in which they were
identified. Although a systematic process was used to identify effectiveness cluster
randomised controlled trials, a large number of published trials will not have been identified
by our search (for example due to the time period or search terms used). The results of our
review therefore may not be generalisable. However, it is also unknown whether a larger
sample would have influenced the overall results of the study. When attempting to identify
secondary publications for the included trials it became evident that authors do not always
include the trial registration numbers in the trial results publications. We carried out
additional searching using publication titles, trial names and author names but were unable to
locate trial registration numbers for ten of the included trials. It is not possible to conclude
whether these trials were not registered or whether the search efforts were unable to locate
registration details. We endeavoured to retrieve all relevant publications, including process
evaluations and reports on training procedures. However, it is possible that details of support
activities may be reported in publications not identified during our searches. It was interesting
to note than in a number of instances the process evaluations did not provide additional
information on actual implementation during the trial or associated measures as the focus of
these publications was on providing in depth qualitative accounts on stakeholders experiences
of the implementation process. Medical Research Council guidance on process evaluations
was published earlier this year which may results in more consistency as to the type of
information reported in these evaluations [17].
As previously mentioned, similar trials [4, 13, 14] have not only looked at whether or not
details have been reported but have also made a judgement as to whether the details provided
were sufficient to merit replication. In this review we opted to assess whether or not authors
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provided details on the items of the TIDieR checklist and provide supporting examples. This
may also be a limitation of the review as the figures provided here without doubt present a
more positive picture than would be the case if we were to make subjective judgements on
the extent to which interventions could be replicated from the details provided.
Meaning of the study
Despite improvements in the quality of reporting of clinical research in recent years, complex
trial designs, and interventions, have resulted in trial reports leaving readers with many
questions unanswered. In this review we have focused in particular on the reporting of
enabling and support activities and implementation fidelity within trials, as this is important
information for both interpreting the research findings and also for clinicians wanting
guidance on how to implement interventions in their practice. We have shown that although
these activities are reported in trials, there exist important gaps when assessed using items of
the TIDieR checklist. Implementation science is a growing field of research, with much
interest in how we can best translate interventions that have been shown to be effective in
research into day-to-day clinical practice. In order to progress this field of research it is
important that authors describe the rationale for their implementation activities, and the
components of these activities in order to contribute to the growing evidence-base.
Publication restrictions pose a particular challenge in achieving this goal and therefore novel
methods of efficiently communicating these details in useable formats are urgently needed.
Unanswered questions and future research
Effectiveness cluster randomised trials of complex non-pharmacological interventions pose
numerous challenges in their design, implementation and reporting. However, there is a
growing appreciation for the nuanced and iterative processes that occur when introducing a
new intervention into routine clinical practice and the role of contextual and personal factors
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[18]. There is a need for more transparent reporting about what is happening in trials to make
informed decisions about the feasibility and effectiveness of interventions, along with their
likely financial and resource implications. There is also a need to establish consensus about
the level of detail that should be reported for such large scale trials to ensure that what is
reported is meaningful and useful for patients, the public, clinicians and researchers.
Copyright
The Corresponding Author has the right to grant on behalf of all authors and does grant on
behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in
all forms, formats and media to i) publish, reproduce, distribute, display and store the
Contribution, ii) translate the Contribution into other languages, create adaptations, reprints,
include within collections and create summaries, extracts and/or, abstracts of the Contribution
and convert or allow conversion into any format including without limitation audio, iii) create
any other derivative work(s) based in whole or part on the on the Contribution, iv) to exploit
all subsidiary rights that currently exist or as may exist in the future in the Contribution, v)
the inclusion of electronic links from the Contribution to third party material where-ever it
may be located; and, vi) licence any third party to do any or all of the above.
Transparency declaration
NM affirms that the manuscript is an honest, accurate, and transparent account of the study
being reported; that no important aspects of the study have been omitted; and that any
discrepancies from the study as planned have been explained.
Ethical approval
Not required.
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Contributors
NM and LC were responsible for study conception and for conducting the original search. All
authors contributed to i) screening studies for inclusion, ii) developing, piloting and refining
the data extraction form and iii) completing data extraction. NM was responsible for
compiling the first draft of the manuscript. All authors were involved in preparing the final
manuscript for submission. NM and LC are the guarantors. All authors had full access to all
of the data in the study and take responsibility for the integrity of the data and the accuracy of
the data analysis.
Competing interests
All authors have completed the Unified Competing Interest form at
www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and
declare that LC is supported by an NIHR Career Development Fellowship which also funds
NM; the authors have no relationships with other organisations that might have an interest in
the submitted work in the previous 3 years; their spouses, partners, or children have no
financial relationships that may be relevant to the submitted work; and they have no non-
financial interests that may be relevant to the submitted work.
Funding
LC is supported by an NIHR Career Development Fellowship that also funds NM. This
article presents independent research funded by the National Institute for Health Research
(NIHR). The views expressed are those of the authors and not necessarily those of the NHS,
the NIHR or the Department of Health.
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Data sharing
Further details of included trials and data extraction is available on request from
References
1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research
evidence. Lancet 2009;374:86-9.
2. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for
reporting parallel group randomised trials. BMC Medicine 2010;8:18.
3. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard
protocol items for clinical trials. Ann Intern Med. 2013;158:200-7.
4. Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological
interventions: analysis of consecutive sample of randomised trials. BMJ 2013;347.
5. Flay BR. Efficacy and effectiveness trials (and other phases of research) in the
development of health promotion programs. Prev Med. 1986;15:451-74.
6. Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more translation of
health promotion research to practice? Rethinking the efficacy-to-effectiveness
transition. Am J Public Health 2003;93:1261-7.
7. Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. A simple and valid tool
distinguished efficacy from effectiveness studies. J Clin Epidemiol 2006;59:1040-8.
8. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic–explanatory continuum
indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol
2009;62:464-75
9. Campbell MK, Mollison J, Steen N, Grimshaw JM, Eccles M. Analysis of cluster
randomized trials in primary care: a practical approach. Fam Pract 2000;17:192-6.
10. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and
evaluating complex interventions: the new Medical Research Council guidance. BMJ
2008;337:a1655.
11. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Grp C. Extending the
CONSORT statement to randomized trials of nonpharmacologic treatment:
Explanation and elaboration. Ann Intern Med 2008;148:295-309.
12. Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions:
template for intervention description and replication (TIDieR) checklist and guide.
BMJ 2014;348.
13. Schroter S, Glasziou P, Heneghan C. Quality of descriptions of treatments: a review
of published randomised controlled trials. BMJ Open 2012;2.
14. Douet L, Milne R, Anstee S, Habens F, Young A, Wright D. The completeness of
intervention descriptions in published National Institute of Health Research HTA-
funded trials: a cross-sectional study. BMJ Open 2014;4:e003713.
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15. Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of
treatment in trials and reviews? BMJ 2008;336:1472.
16. Papadakis S, Gharib M, Hambleton J, Reid RD, Assi R, Pipe AL. Delivering
evidence-based smoking cessation treatment in primary care practice: experience of
Ontario family health teams. Can Fam Physician 2014;60:e362-71.
17. Moore GF, Audrey S, Barker M, et al. Process evaluation of complex interventions:
Medical Research Council guidance. BMJ 2015;350:h1258.
18. Wells M, Williams B, Treweek S, Coyle J, Taylor J. Intervention description is not
enough: evidence from an in-depth multiple case study on the untold role and impact
of context in randomised controlled trials of seven complex interventions. Trials
2012;13:95-111.
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Figure 1. PRISMA flow diagram 158x214mm (300 x 300 DPI)
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Supplementary file 1: Search strategy (22.09.2014):
1. (randomised or randomized).m_titl. (109896)
2. implement*.ti,ab. (261884)
3. (cluster or multi-site or multi-centre).m_titl. (22294)
4. "intervent*".m_titl. (87510)
5. 2 or 4 (341756)
6. ((trial or study) not protocol).m_titl. (1070741)
7. 1 and 3 and 6 (2093)
8. 5 and 7 (761)
9. limit 9 to yr="2008 - 2014" (630)
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Supplementary file 2: Data extraction form and completed example
Data extraction form
First author of trial results publication
Blackberry
Publication Title Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial.
Trial Acronym PEACH
Trial Registration ISRCTN50662837
Journal Citation Blackberry ID, Furler JS, Best JD, Chondros P, Vale M, Walker C, et al. Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial. BMJ. 2013;347:f5272.
Journal BMJ
Year 2013
Study Design Cluster randomised controlled trial
Publication type Trial results
Other relevant trial publications
PROTOCOL: Young D, Furler J, Vale M, Walker C, Segal L, Dunning P, et al. Patient Engagement and Coaching for Health: The PEACH study--a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol. BMC Fam Pract. 2007;8:20.
Topic Type 2 Diabetes
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Aim To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia.
Name/type of the intervention
Patient Engagement and Coaching for Health intervention (PEACH). (self-management)
HCPs implementing the intervention
Nurses
Setting General practices
Enabling or support activities
Made reference to enabling or support activities
Yes
Rationale for the activities Not described
Who provided The research team provides on-site assistance to the practice nurse in their first two baseline interviews and questionnaire administration to ensure quality of data collection.
What materials Practices were reimbursed for their nurses’ time spent on the PEACH study, including for patient recruitment, data collection, and delivery of the intervention.
Where On-site assistance
When Unclear
How Each practice nurse from practices assigned to the intervention group completed a two day training programme in telephone coaching. / The research team provided support to practice nurses during the intervention period, including one visit to the practice, monthly telephone calls, and a group meeting, where all intervention practice nurses could share their experience and learning from conducting telephone coaching.
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How much An initial 15 hours of telephone coaching training over two days, and further support and training was provided to individual nurses after assessment of their progress.
Tailoring None described
Modifications None described
Measures of fidelity for the enabling or support activities (e.g. monitoring attendance at training sessions)
Not described
Actual implementation of support activities (e.g. had to increase number of sessions to accommodate staff turnover)
Not described
Competency checking in advance of implementation /accreditation
None described
Fidelity of implementation of intervention being tested
Strategy used to monitor fidelity
The "Head Coach" (MV) monitors the first telephone coaching and random subsequent telephone coaching.
Extent to which the intervention was delivered as planned
The intensity and fidelity of the intervention was compromised so that the intended dose of the intervention was not delivered to a high proportion of patients and in many cases the key element of a focus on medication intensification through negotiation with the treating general practitioners was not achieved. Intervention fidelity also seems to have been compromised. Content analysis of calls showed many consultations did not explicitly address medication intensification, an important part of the coaching programme.
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Supplementary file 3: Publications included in data extraction
ID First author/year of trial results publication Trial registration number No. Trial publications included in data extraction
1 Adachi 2013 UMIN000004049 2
PROTOCOL: • Adachi M, Yamaoka K, Watanabe M, et al. Effects of lifestyle
education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial. BMC Public Health 2010;10:742.
RESULTS: • Adachi M, Yamaoka K, Watanabe M, et al. Effects of lifestyle
education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial. BMC Public Health 2013;13:467.
2 Armour 2013 None identified 1
RESULTS: • Armour CL, Reddel HK, LeMay KS, et al. Feasibility and
effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial. J Asthma 2013;50:302-9.
3 Blackberry 2013 ISRCTN50662837 2
PROTOCOL: • Young D, Furler J, Vale M, et al. Patient Engagement and
Coaching for Health: The PEACH study--a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol. BMC Fam Pract 2007;8:20.
RESULTS: • Blackberry ID, Furler JS, Best JD, et al. Effectiveness of general
practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial. BMJ 2013;347:f5272.
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4 Cabezas 2011 NCT00125905 2
PROTOCOL: • Cabezas C, Martin C, Granollers S, et al. Effectiveness of a
stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial. BMC Public Health 2009;9:48.
RESULTS: • Cabezas C, Advani M, Puente D, Rodriguez-Blanco T, Martin C,
Group IS. Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study). Addiction 2011;106:1696-706.
5 Chao 2014 None identified 1
RESULTS: • Chao YH, Usher K, Buettner PG, Holmes C. Cluster randomised
controlled trial: educational self-care intervention with older Taiwanese patients with type 2 diabetes mellitus--impact on blood glucose levels and diabetic complications. Collegian 2014;21:43-51.
6 Deales 2014 ACTRN12611000813987 1
RESULTS: • Deales A, Fratini M, Romano S, et al. Care manager to control
cardiovascular risk factors in primary care: the Raffaello cluster randomized trial. Nutr Metab Cardiovasc Dis 2014;24:563-71.
7 Derde 2014 NCT00976638 1
RESULTS: • Derde LP, Cooper BS, Goossens H, et al. Interventions to reduce
colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial.[Erratum appears in Lancet Infect Dis. 2014 Jan;14(1):11]. Lancet Infect Dis 2014;14:31-9.
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8 Dinneen 2013 ISRCTN79759174 2
PROTOCOL: • Dinneen SF, MC OH, Byrne M, et al. The Irish DAFNE study
protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. Trials 2009;10:88.
RESULTS: • Dinneen SF, O'Hara MC, Byrne M, et al. Group follow-up
compared to individual clinic visits after structured education for type 1 diabetes: a cluster randomised controlled trial. Diabetes Res Clin Pract 2013;100:29-38.
9 Garcia-Cardenas 2013 NCT01085474 1
RESULTS: • Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, Martinez-
Martinez F, Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med 2013;107:1346-55.
10 Grandes 2009 NCT00131079 1
RESULTS: • Grandes G, Sanchez A, Sanchez-Pinilla RO, et al. Effectiveness
of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med 2009;169:694-701.
11 Hafkamp-de Groen 2014 ISRCTN15790308 2
PROTOCOL: • Hafkamp-de Groen E, Mohangoo AD, de Jongste JC, et al. Early
detection and counselling intervention of asthma symptoms in preschool children: study design of a cluster randomised controlled trial. BMC Public Health 2010;10:555.
RESULTS: • Hafkamp-de Groen E, van der Valk RJ, Mohangoo AD, et al.
Evaluation of systematic assessment of asthma-like symptoms and tobacco smoke exposure in early childhood by well-child professionals: A randomised trial. PLoS One 2014;9:e90982.
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12 Haller 2014 ACTRN12608000432314 1
RESULTS: • Haller DM, Meynard A, Lefebvre D, Ukoumunne OC, Narring
F, Broers B. Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial. CMAJ 2014;186:E263-72.
13 Hegarty 2010 ACTRN12608000032358 2
PROTOCOL: • Hegarty KL, Gunn JM, O'Doherty LJ, et al. Women's evaluation
of abuse and violence care in general practice: a cluster randomised controlled trial (weave). BMC Public Health 2010;10:2.
RESTULTS: • Hegarty K, O'Doherty L, Taft A, et al. Screening and counselling
in the primary care setting for women who have experienced intimate partner violence (WEAVE): a cluster randomised controlled trial. Lancet 2013;382:249-58.
14 Hoddinott 2009 ISRCTN44857041 2
RESULTS: • Hoddinott P, Britten J, Prescott GJ, Tappin D, Ludbrook A,
Godden DJ. Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial. BMJ 2009;338:a3026.
PROCESS EVALUATION: • Hoddinott P, Britten J, Pill R. Why do interventions work in
some places and not others: a breastfeeding support group trial. Soc Sci Med 2010;70:769-78
15 Hopkinson 2010 None identified 1
RESULTS: • Hopkinson JB, Fenlon DR, Okamoto I, et al. The deliverability,
acceptability, and perceived effect of the Macmillan approach to weight loss and eating difficulties: a phase II, cluster-randomized, exploratory trial of a psychosocial intervention for weight- and eating-related distress in people with advanced cancer. J Pain Symptom Manage 2010;40:684-95.
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16 Jahn 2009 None identified 1
RESULTS: • Jahn P, Renz P, Stukenkemper J, et al. Reduction of
chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: a cluster-randomized multicenter trial. Support Care Cancer 2009;17:1543-52.
17 Kennedy 2013 ISRCTN90940049 3
PROTOCOL: • Bower P, Kennedy A, Reeves D, et al. A cluster randomised
controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol. Implement Sci 2012;7:7.
RESULTS: • Kennedy A, Bower P, Reeves D, et al. Implementation of self
management support for long term conditions in routine primary care settings: cluster randomised controlled trial. BMJ 2013;346:f2882.
PROCESS EVALUATION: • Kennedy A, Rogers A, Chew-Graham C, et al. Implementation
of a self-management support approach (WISE) across a health system: a process evaluation explaining what did and did not work for organisations, clinicians and patients. Implement Sci 2014;9:129.
18 Labhardt 2011 NCT00744458 1
RESULTS: • Labhardt ND, Balo JR, Ndam M, Manga E, Stoll B. Improved
retention rates with low-cost interventions in hypertension and diabetes management in a rural African environment of nurse-led care: a cluster-randomised trial. Trop Med Int Health 2011;16:1276-84.
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19 Law 2011 None identified 1
RESULTS: • Law MC, Darrah J, Pollock N, et al. Focus on function: a cluster,
randomized controlled trial comparing child- versus context-focused intervention for young children with cerebral palsy. Dev Med Child Neurol 2011;53:621-9.
20 Leendertse 2013 NTR 2647 2
PROTOCOL: • Leendertse AJ, de Koning FH, Goudswaard AN, et al.
Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study. BMC Health Serv Res 2011;11:4.
RESULTS: • Leendertse AJ, de Koning GH, Goudswaard AN, et al.
Preventing hospital admissions by reviewing medication (PHARM) in primary care: an open controlled study in an elderly population. J Clin Pharm Ther 2013;38:379-87.
21 Leonhardt 2008 None identified 1
RESULTS: • Leonhardt C, Keller S, Chenot JF, et al. TTM-based motivational
counselling does not increase physical activity of low back pain patients in a primary care setting--A cluster-randomized controlled trial. Patient Educ Couns 2008;70:50-60.
22 Leontjevas 2013 NTR1477 2
PROTOCOL: • Gerritsen DL, Smalbrugge M, Teerenstra S, et al. Act In case of
Depression: the evaluation of a care program to improve the detection and treatment of depression in nursing homes. Study Protocol. BMC Psychiatry 2011;11:91.
RESULTS: • Leontjevas R, Gerritsen DL, Smalbrugge M, Teerenstra S,
Vernooij-Dassen MJ, Koopmans RT. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial. Lancet 2013;381:2255-64.
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23 Luoto 2011 ISRCTN33885819 2
PROTOCOL: • Luoto RM, Kinnunen TI, Aittasalo M, et al. Prevention of
gestational diabetes: design of a cluster-randomized controlled trial and one-year follow-up. BMC Pregnancy Childbirth 2010;10:39.
RESULTS: • Luoto R, Kinnunen TI, Aittasalo M, et al. Primary prevention of
gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial. PLoS Med 2011;8:e1001036.
24 Magoma 2013 ACTRN12609000268246 1
RESULTS: • Magoma M, Requejo J, Campbell O, Cousens S, Merialdi M,
Filippi V. The effectiveness of birth plans in increasing use of skilled care at delivery and postnatal care in rural Tanzania: a cluster randomised trial. Trop Med Int Health 2013;18:435-43.
25 Metzelthin 2013 ISRCTN31954692 3
PROTOCOL: • Metzelthin SF, van Rossum E, de Witte LP, Hendriks MR,
Kempen GI. The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial. BMC Public Health 2010;10:511.
RESULTS: • Metzelthin SF, van Rossum E, de Witte LP, et al. Effectiveness
of interdisciplinary primary care approach to reduce disability in community dwelling frail older people: cluster randomised controlled trial. BMJ 2013;347:f5264.
PROCESS EVALUATION: • Metzelthin SF, Daniels R, van Rossum E, et al. A nurse-led
interdisciplinary primary care approach to prevent disability among community-dwelling frail older people: a large-scale process evaluation. Int J Nurs Stud 2013;50:1184-96.
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26 Meyer 2012 NCT00679861 1
RESULTS: • Meyer C, Ulbricht S, Gross B, et al. Adoption, reach and
effectiveness of computer-based, practitioner delivered and combined smoking interventions in general medical practices: a three-arm cluster randomized trial. Drug Alcohol Depend 2012;121:124-32.
27 Morrell 2009 ISRCTN92195776 3
RESULTS: • Morrell CJ, Slade P, Warner R, et al. Clinical effectiveness of
health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care. BMJ 2009;338:a3045.
HEALTH TECHNOLOGY ASSESSMENT REPORT: • Morrell CJ, Warner R, Slade P, et al. Psychological interventions
for postnatal depression: cluster randomised trial and economic evaluation. The PoNDER trial. Health Technol Assess 2009;13:iii-iv, xi-xiii, 1-153.
TRAINING OF HEALTH VISITORS: • Morrell CJ, Ricketts T, Tudor K, Williams C, Curran J, Barkham
M. Training health visitors in cognitive behavioural and person-centred approaches for depression in postnatal women as part of a cluster randomised trial and economic evaluation in primary care: the PoNDER trial. Prim Health Care Res Dev 2011;12:11-20.
28 Nokela 2010 None identified 1
RESULTS: • Nokela M, Arnlind MH, Ehrs PO, Krakau I, Forslund L, Jonsson
EW. The influence of structured information and monitoring on the outcome of asthma treatment in primary care: a cluster randomized study. Respiration 2010;79:388-94.
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29 Papadakis 2013 NCT00799279 1
RESULTS: • Papadakis S, McDonald PW, Pipe AL, Letherdale ST, Reid RD,
Brown KS. Effectiveness of telephone-based follow-up support delivered in combination with a multi-component smoking cessation intervention in family practice: a cluster-randomized trial. Prev Med 2013;56:390-7.
30 Pladevall 2010 ISRCTN35208258 1
RESULTS: • Pladevall M, Brotons C, Gabriel R, et al. Multicenter cluster-
randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study). Circulation 2010;122:1183-91.
31 Pope 2008 None identified 2
RESULTS: • Pope DS, Deluca AN, Kali P, et al. A cluster-randomized trial of
provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa. J Acquir Immune Defic Syndr 2008;48:190-5.
NURSES EXPERIENCES OF IMPLEMENTATION: • Pope DS, Atkins S, DeLuca AN, et al. South African TB nurses'
experiences of provider-initiated HIV counseling and testing in the Eastern Cape Province: a qualitative study. AIDS Care 2010;22:238-45.
32 Quinn 2011 None identified 2
PROTOCOL: • Quinn CC, Gruber-Baldini AL, Shardell M, et al. Mobile
diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials 2009;30:334-46.
RESULTS: • Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH,
Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care 2011;34:1934-42.
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33 Rat 2014 NCT01610531 1
RESULTS: • Rat C, Quereux G, Riviere C, et al. Targeted melanoma
prevention intervention: a cluster randomized controlled trial. Ann Fam Med 2014;12:21-8.
34 Roisin 2014 NCT00846105 1
RESULTS: • Roisin S, Laurent C, Denis O, et al. Impact of rapid molecular
screening at hospital admission on nosocomial transmission of methicillin-resistant staphylococcus aureus: cluster randomised trial. PLoS One 2014;9:e96310.
35 Septimus 2014 None identified 1
RESULTS: • Septimus EJ, Hayden MK, Kleinman K, et al. Does
chlorhexidine bathing in adult intensive care units reduce blood culture contamination? A pragmatic cluster-randomized trial. Infect Control Hosp Epidemiol 2014;35 Suppl 3:S17-22.
36 Slater 2013 ACTRN12611000053921 1
RESULTS: • Slater H, Briggs AM, Watkins K, Chua J, Smith AJ. Translating
evidence for low back pain management into a consumer-focussed resource for use in community pharmacies: a cluster-randomised controlled trial. PLoS One 2013;8:e71918.
37 Sonnichsen 2010 ISRCTN27414162 2
PROTOCOL: • Sonnichsen AC, Rinnerberger A, Url MG, et al. Effectiveness of
the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial. Trials 2008;9:38.
RESULTS: • Sonnichsen AC, Winkler H, Flamm M, et al. The effectiveness
of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial. BMC Fam Pract 2010;11:86.
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38 Spijker 2011 NCT00147693 3
PROTOCOL: • Spijker A, Verhey F, Graff M, et al. Systematic care for
caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial. BMC Geriatr 2009;9:21.
RESULTS: • Spijker A, Wollersheim H, Teerenstra S, et al. Systematic care
for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial. Am J Geriatr Psychiatry 2011;19:521-31.
ASSESSMENT OF IMPLEMENTATION: • Spijker A, Teerenstra S, Wollersheim H, Adang E, Verhey F,
Vernooij-Dassen M. Influence of adherence to a systematic care program for caregivers of dementia patients. Am J Geriatr Psychiatry 2013;21:26-36.
39 Stewart 2014 ACTRN12609000705280 2
PROTOCOL: • Lau R, Stewart K, McNamara KP, et al. Evaluation of a
community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial. BMC Health Serv Res 2010;10:34.
RESULTS: • Stewart K, George J, Mc Namara KP, et al. A multifaceted
pharmacist intervention to improve antihypertensive adherence: a cluster-randomized, controlled trial (HAPPy trial). J Clin Pharm Ther 2014;39:527-34.
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40 van de Ven 2013 NTR2314 2
PROTOCOL: • van de Ven G, Draskovic I, Adang EM, et al. Improving person-
centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial. BMC geriatr 2012;12:1.
RESULTS: • van de Ven G, Draskovic I, Adang EM, et al. Effects of
dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial. PLoS One 2013;8:e67325.
41 van den Bemt 2009 NCT00542061 1
RESULTS: • van den Bemt L, Schermer TR, Smeele IJ, et al. An expert-
supported monitoring system for patients with chronic obstructive pulmonary disease in general practice: results of a cluster randomised controlled trial. Med J Aust 2009;191:249-54.
42 Vicens 2014 ISRCTN13024375 2
PROTOCOL: • Vicens C, Socias I, Mateu C, et al. Comparative efficacy of two
primary care interventions to assist withdrawal from long term benzodiazepine use: a protocol for a clustered, randomized clinical trial. BMC Fam Pract 2011;12:23.
RESULTS: • Vicens C, Bejarano F, Sempere E, et al. Comparative efficacy of
two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care. Br J Psychiatry 2014;204:471-9.
43 Weaver 2014 ISRCTN72794493 1
RESULTS: • Weaver T, Metrebian N, Hellier J, et al. Use of contingency
management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial. Lancet 2014;384:153-63.
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44 Wolfe 2010 ISRCTN10730637 1
RESULTS: • Wolfe CD, Redfern J, Rudd AG, Grieve AP, Heuschmann PU,
McKevitt C. Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke. Stroke 2010;41:2470-6.
45 Zatzick 2014 NCT00607620 2
RESULTS: • Zatzick D, Donovan DM, Jurkovich G, et al. Disseminating
alcohol screening and brief intervention at trauma centers: a policy-relevant cluster randomized effectiveness trial. Addiction 2014;109:754-65.
EVALUATION OF TRAINING: • Darnell D, Dunn C, Atkins D, Ingraham L, Zatzick D. A
Randomized Evaluation of Motivational Interviewing Training for Mandated Implementation of Alcohol Screening and Brief Intervention in Trauma Centers. J Subst Abuse Treat 2015 [Epub ahead of print].
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Supplementary file 4: Characteristics of included trials
Categories n
Condition
Type 2 diabetes 5 Asthma 4
Cardiovascular disease, hypertension, stroke 4 Maternal/child health (Breastfeeding, gestational
diabetes mellitus (GDM), postnatal depression) 4
Cancer 3 Infection control 3
Smoking cessation 3 Dementia 2
Multiple long term conditions 2 Low back pain 2
Other (intimate partner violence, frailty) 2 Substance use 2
Pharmacotherapy 2 Alcohol consumption 1
Chronic obstructive pulmonary disease 1 Depression 1
HIV 1 Cerebral palsy 1
Physical activity 1 Type 1 diabetes 1
Categories n
Healthcare professionals
implementing the intervention
Nurses 12 Mixed 12
GPs 10 Pharmacists 4
ICU staff 2 Community teams (mental health, palliative care) 2
Dieticians 1 Hospital doctors 1
Allied health professionals 1 Categories n
Setting
Primary care 23 Specialist centres/services 5
Community pharmacies 4 Community teams 2
Hospitals 2 Intensive care units 2
Outpatient clinics 2 Mixed 2
Other (trauma unit, dispensary, German centre) 2 Nursing homes 1
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Categories n
Type of intervention
Lifestyle/Education/Self-management (e.g. counselling, motivational interviewing, smoking
cessation) 22 Multi-/interdisciplinary case management 6
Screening and brief intervention 4 Infection control strategies 3
Other 2 Pharmacotherapy (e.g. discontinuation of
benzodiazepine) 2 Treatment contracts/incentives (e.g. vaccinations) 2
Breastfeeding policy 1 COPD monitoring system with expert
recommendations 1 Psychosocial intervention in cancer care 1
Neurological rehabilitation 1 Categories n
Country
The Netherlands 7 Australia 5
Spain 5 UK 5
Germany 3 USA 3
Canada 2 Austria 1
Belgium 1 Cameroon 1
Europe 1 Finland 1 France 1 Ireland 1
Italy 1 Japan 1
Scotland 1 South Africa 1
Sweden 1 Switzerland 1
Taiwan 1 Tanzania 1
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Supplementary file 5: Examples of reporting, and variation across trials for the individual components The purpose of this table is to provide examples of the variation in reporting across trials. Quotes provided may relate to a number of items but
have been provided with the item to which they are most closely related. Trial ID numbers (Supplementary file 3) are also provided.
Item More detailed reports More typical reports
Why The development and evaluation of the training intervention have taken place prior to this trial, and details of the theoretical background and content have been published elsewhere. The planned approach to training combines evidence-based approaches to changing professional behaviour with approaches to ‘normalise’ those behaviours in current practice. #17
The intervention components were selected based on a review of the literature of evidence-based strategies for integrating smoking cessation into primary care settings. #29
Who provided The education is delivered by a Diabetes Specialist Nurse, Dietitian and Doctor all of whom have undergone training in delivery of the DAFNE curriculum. #8
The training sessions were designed by 2 of us (D.M.H. and A.M., both family physicians trained in adolescent health; A.M. is also a trainer in motivational interviewing). #12
Before the start of the study, registered dietitians had the opportunity to gain experience with the intervention protocol under supervision by the project team. #1
What materials Several aids have been developed to facilitate the use of the SCPD:
1. The SCPD screening tool. The questions for the screening a caregiver's sense of competence and depressive symptoms are printed on a handy plasticized pocket card.
2. The SCPD manual. The manual consists of the items to be discussed during the training sessions (i.e., background
Materials and resources were made available as hard copy, online and on CDs, to provide flexible learning opportunities. #39
A training manual was written by the research team and provided to all nurses. #41
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information and methods), and some supporting literature has been added.
3. The starter package and action list. Several forms have been developed for the requested data. The starter package contains the forms that professionals need to gather these data. The action list contains 60 possible intervening and supportive actions that professionals might undertake as a result of the screening. They are divided into nine categories: intake, diagnostics, psychoeducation, psychosocial care, medical care, how to hand over care, legal care, case management, and crisis management. #38
Where No examples were identified of more detailed reports on location/setting for enabling or support activities. This item of the TIDieR checklist prompts authors to describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features
Training consisted of a distance learning package (6 hours; reading, audit of patients, four interactive group teleconference sessions) and two one-hour interactive practice visits delivered by an academic GP. #13
First, the team visited NH units before crossing over to the intervention condition, explained the program and delivered three tailored packages to psychologists, physicians, and nursing staff including unit managers and activity therapists. #22
When This training was conducted as pre-trial workshops (HS), during which pharmacists were instructed about the key pamphlet messages to reinforce and were advised about the necessity of delivering these messages strictly in accordance with the pamphlet content. Pharmacists were encouraged to request clarification and feedback in regards to delivery of the messages at the time of these workshops and throughout the trial if/as required. #36
All nurses had previously received training in provision of HBV vaccinations. #43
Before and during the intervention period the GP and the pharmacist are offered support by training, education and a web based community of practice with a helpdesk on pharmacotherapy. #20
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The on-site workshop was followed over the next 6 months by four trainer-led 30-minute telephone coaching sessions during which MI skills were practised and subsequently boosted with written feedback via e-mail. Following the 6-month training period, intervention site SBI providers delivered bedside SBI to injured patients. #45
How Intervention site nursing and social work SBI providers learned to deliver MI during a 1-day workshop delivered by the study trainer (CD). The workshop training targeted a 20–30-minute MI that could be delivered at bedside to injured in-patients by the full spectrum of trauma center providers (e.g. social work and nursing providers). The workshop emphasized MI skill development and the importance of spending adequate time conducting interventions by the bedside with injured in-patients. The on-site workshop was followed over the next 6 months by four trainer-led 30-minute telephone coaching sessions during which MI skills were practised and subsequently boosted with written feedback via e-mail. #45
The Healthy Relationships Training programme. Training consisted of a distance learning package (6 hours; reading, audit of patients, four interactive group teleconference sessions) and two one-hour interactive practice visits delivered by an academic GP (including one visit with a simulated patient who role-played different readiness to change scenarios). #13
Several meetings about the aspects and basic principles of the intervention protocol took place (i.e. the screening procedure, self-management principles, client centeredness, motivational interviewing, interdisciplinary collaboration, assessment tools, parts of the toolbox and referrals). #1
The professionals were provided with a two-hour specific training on how to apply and use the brief assessment form regarding asthma-like symptoms and ETS exposure. #11
All nurses in all groups participated in a 4-h training session on how to establish a treatment contract with hypertensive patients or patients with diabetes. #18
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How much An initial 15 hours of telephone coaching training over two days, and further support and training was provided to individual nurses after assessment of their progress. #3
The process of becoming a DAFNE centre involves 43 h of training for a DAFNE doctor and 105 h of training for each of the (at least 2). #8
All nurses were supported with meetings every third month during the intervention. #23
Tailoring No examples were identified of more detailed reports on tailoring of enabling or support activities. This item of the TIDieR checklist prompts authors to describe if the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how
Consistent with the person-centred approach to education, the training course paid attention to developing trust, participation, acceptance, excitement, and curiosity, partly by having check in, group and process time at the beginning and end of each day, which encouraged personal sharing and processing; and partly by being flexible about the order of the content of the course. #27
Modifications No examples were identified of more detailed reports on modifications to the enabling or support activities during the course of the trial. This item of the TIDieR checklist prompts authors to describe if the intervention was modified during the course of the study, describe the changes (what, why, when, and how)
Ensuring that training was acceptable at step 3 required considerable compromise in restricting the length and content of training to match the time that practices were willing to devote. #17
Measure of planned support activities
No examples were identified of more detailed reports on planned measures of enabling or support activities provided. This item of the TIDieR checklist prompts authors to describe if adherence or fidelity was assessed, and if so to describe how and by whom, and if any strategies were used to maintain or improve fidelity
Evaluations of teaching sessions: facilitators evaluate the extent of the planned content of each teaching session by completing a standardized evaluation form. This ensures the consistency of the program delivery at each site. #4
Actual support activities
No examples were identified of more detailed reports on actual enabling or support activities delivered. This item of
All implementation strategies were provided to almost all new staff members except for new caregivers, who
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the TIDieR checklist prompts authors to describe the extent to which the intervention (i.e. the enabling or support activities in this case) was delivered as planned
mostly did not follow a new depression course but were supervised by the unit managers. #22
Competency checking
The readiness of GPs to manage intimate partner abuse is assessed before and after the training using PREMIS, a validated questionnaire assessing knowledge, attitude and behaviours of doctors with regard to intimate partner violence. #13
Evaluation of the translation of knowledge and skills into practice was built into the course, in the form of a MAWE reflective diary (used to facilitate learning, but also as research data). / Before recruiting trial participants, nurses were required to give the researcher a verbal or written example of practicing each component of the intervention. They then made a self-assessment of confidence and competence to practice MAWE before recruiting into the trial. This took a period of time ranging from one to four months per nurse. #15
Participating pharmacists underwent training and subsequent assessment of knowledge and skills. Pharmacists were required to demonstrate a defined standard of competence. #39
Fidelity of implementation of intervention being tested
Item More detailed reports More typical reports
Strategy used to monitor fidelity
Two research nurses in each ICU were centrally trained to do hand hygiene observations. 15 observation sessions, of 15–30 min, were done every month throughout the study at the ICUs. / We checked 10% of all electronic case report forms against data collected at each ICU, and checked all procedures for consistency once during phase 1 and once during phase. #7
Intervention group interviews were recorded randomly in order to ensure the quality of the sessions and the compliance with techniques learned during the training. #4
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Extent to which the intervention was delivered as planned
Sixty-nine percent of the dyads were exposed to the intervention. They received an average of 3.09 (SD: 2.97) counselling sessions, including the assessment procedure. Fifty-six percent of these dyads received an average of 19.22 (SD: 16.65) supportive actions after the screening. / The professionals did not systematically screen the caregivers. Thirty-one percent of the dyads in the intervention group had not received a systematic assessment. However, adjusting for the extent to which professionals carried out the intervention as planned did not yield different effects on institutionalization. #38
However, the correct use of the checklist was promoted and monitored during training. According to these reports, most of the patients were screened for substance use and exposed to at least 2 of the 5 elements of the brief intervention. #12
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PRISMA Checklist
Section/topic # Checklist item Reported on page #
TITLE
Title 1 Identify the report as a systematic review, meta-analysis, or both.
- Identified as a review in the title and descriptive review in the abstract 1
ABSTRACT
Structured summary 2
Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.
- We did not have a systematic review registration number due to the nature of the review
2
INTRODUCTION
Rationale 3 Describe the rationale for the review in the context of what is already known. 4-6
Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS). 4-6
METHODS
Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if
available, provide registration information including registration number. No
Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale. 7
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Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched. 7
Search 8 Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated. S1
Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis). 7
Data collection process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate)
and any processes for obtaining and confirming data from investigators. 8
Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made. 8
Risk of bias in individual studies 12
Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.
Not included
Summary measures 13 State the principal summary measures (e.g., risk ratio, difference in means). N/A
Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I2) for each meta-analysis. 9
Risk of bias across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication
bias, selective reporting within studies). Not included
Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified. N/A
RESULTS
Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram. 9
Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations. S4
Risk of bias within studies 19 Present data on risk of bias of each study and, if available, any outcome level assessment (see item
12). Not included
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Results of individual studies 20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data
for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot. N/A
Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. N/A
Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see Item 15). N/A
Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). N/A
DISCUSSION
Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider
their relevance to key groups (e.g., healthcare providers, users, and policy makers). 12-15
Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias). 14-15
Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research. 15-17
FUNDING
Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review. 19
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