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Table 3 Characteristics of included studies

From: Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used

Study

Country

Intervention

Framework adopted

Focus of the optimisation process

Methods

Outcome

Barley et al. 2012 [30]

UK

Nurse-led intervention to improve mood and cardiac outcomes in depressed coronary health disease patients

MRC framework 2008

Determine potential acceptability of the intervention to patients (in terms of method of delivery, duration and components), identify changes needed in relation to intervention components

Focus groups with patients (n = 13) and further evidence review to confirm/modify intervention components

The intervention was tested further in a feasibility study

Burr et al. 2011 [33]

UK

Glaucoma screening intervention

MRC framework 2008

Determine feasibility and acceptability to eye care providers, policy makers and health service commissioners of a range of intervention combinations and relative cost-effectiveness

Semi-structured interviews with eye care providers (n = 25), nurses (n = 5), GPs (n = 4), healthcare service commissioners and policy makers (n = 9), economic modelling

The integration of findings allowed to isolate a short list of candidate components that could be implemented in a RCT

Byng and Jones 2004 [40]

UK

Mental Health Link, an intervention to improve shared care for patients with long-term mental illness

MRC framework 2000

Critique the proposed intervention and evaluate practitioners’ perceptions of the different components of the intervention

Multi-method iterative design, including focus groups with a group of mixed health care professionals (n = 10) and a group of local experts in primary mental health (n = 6), semi-structured questionnaires and in-depth interviews

The intervention and the core components were refined and details added before this was piloted in three practices

Carnes et al. 2013 [25]

UK

Self-management intervention for chronic pain patients

MRC framework 2008

Test the feasibility of delivering the intervention and the receipt of the intervention

Uncontrolled pilot study, including observations, feedback questionnaires to course facilitators and participants, and participants interviews (n = 13)

Findings supported the development of a definitive RCT

Clyne et al. 2013 [26]

Ireland

OPTI-SCRIPT intervention to decrease potentially inappropriate prescribing (PIP) in older people

MRC framework 2000 and 2008

Testing of the components of the intervention with GPs (assessing GP perspectives on intervention and testing of the intervention

Focus groups and interviews with GPs

Intervention components were refined and a third component identified. Findings from the pilot study allowed further refinement to produce the finalised

Collins et al. 2005 [10]

USA

Smoking cessation intervention

MOST framework

Identify the most effective set of intervention components

16-cell fractional factorial experiments to test six components and their combinations

Phase to be completeda

Collins et al. 2011 [44]

USA

Smoking cessation intervention

MOST framework

Identify the most effective components or combination of components and the appropriate dosage levels

Fractional factorial design with 32 experimental conditions to test six intervention components

Phase to be completeda

Eldridge et al. 2005 [50]

UK

Intervention to prevent fall-related injuries in older people

Not specified

Estimate intervention effectiveness and long-term impact

Probability analysis for the effectiveness of the intervention, Markov model of long-term effectiveness and cost-effectiveness of the intervention

Results suggested that the intervention would be minimally effective. The intervention did not move to the full-scale RCT

Ettema et al. 2014 [24]

Netherlands

The Prevention of Decline in Older Cardiac Surgery Patients (PREDOCS) programme, a nursing intervention to prepare frail older patients for cardiac surgery

MRC framework 2008

Delineate intervention components, identify how components could be interrelated and identify how components relate to the outcomes

Comparison of evidence on effective interventions derived from the systematic review with the valuable theoretical understanding of the likely process of change obtain from the analytical study; survey study amongst nurses (n = 250), semi-structured interviews with patients

Findings led to the development of the intervention that was then tested for face validity

Farquhar et al. 2011 [34]

UK

Palliative Breathlessness Intervention Service (BIS) in patients with intractable dyspnoea

MRC framework 2000 and 2008

Explore participants’ experience of using the intervention and clinicians’ experience of referring patients to the service

Interviews with patients and patients’ relatives (n = 10), clinicians (n = 4) who had use the drafted service

The intervention was remodelled on the basis of the findings and then piloted

Booth et al. 2006[52]

Grant et al. 2014 [48]

UK

Data-driven quality improvement in primary care (DQIP) intervention to improve prescribing safety in primary care

Not reported

Explore GPs and practice managers’ perception of the value of the specific components of the intervention (education, informatics and financial), their experience of adopting and implementing the intervention into routine practice and to changing prescribing behaviour

Semi-structured interviews with GPs and practice managers

Practice experiences identified some barriers which facilitated optimising the intervention beyond suggestions in the literature on changing prescribing

Gray et al. 2013 [27]

UK

The Football Fans in Training (FFIT) weight loss intervention for adult men

MRC framework 2008

Gain feedback from participants and coaches on the programme and its delivery

Observations, interviews and focus groups with participants and coaches and questionnaire to participants

The intervention was refined and then tested in a full-scale RCT

Hrisos et al. 2008 [46]

UK

Two behavioural interventions to promote GP management of upper respiratory tract infection (URTI) without prescribing antibiotics

Intervention modelling experiment

Explore the potential effect of the intervention on proxy outcomes that represent the actual behaviour

2 × 2 factorial randomised controlled trial involving 340 GPs. GPs were asked to complete two postal questionnaire surveys which included clinical scenarios

Findings encouraged the development of a replicable methodology for the design, evaluation and refinement of interventions prior to service-level RCTs

Kirkevold et al. 2012 [31]

Norway

nursing intervention for psychological health and well-being after stroke

MRC framework 2000 and 2008

Evaluate and critique the intervention by patient and relative representatives, clinical experts and researchers

Consensus process involving a wide range of healthcare professionals patients representatives and family carers

The intervention was refined and then tested in a feasibility study

Lewis et al. 2013 [28]

UK

Guided self-help (GSH) intervention for the treatment of mild-to-moderate post-traumatic stress disorder (PTSD)

MRC framework 2000 and 2008

Test the intervention potential effect and stakeholders’ perspective in order to refine the intervention

2 small-scale and uncontrolled pilot studies (n = 10 and n = 9) including pre and post treatment quantitative data, interviews with participants taking part in the pilots and focus groups with healthcare professionals and stakeholders involved in the development of the prototype

Findings from the first pilot led to the development of the intervention prototype, which was then tested in a second pilot. Results were used to refine the programme in order to produce the finalised programme

Lovell et al. 2008 [35]

UK

Guided self-help intervention for depression in primary care

MRC framework 2000

Synthesise available evidence on the effectiveness of the intervention, identify key factors that may moderate effectiveness and deal with uncertainties emerging from the reviews, assess of acceptability to patients and healthcare professionals

Meta-regression, meta-analysis and a consensus process with experts, including academics (n = 8), health professionals (n = 10) and service users (n = 1), phone interviews with patients and healthcare professionals

The integration of findings allowed identifying the ‘core components’ of the intervention, which was then tested in feasibility study. The intervention did not moved to the RCT phase, as it did not markedly improve outcomes in the exploratory study

Munir et al. 2013 [42]

UK

Work-related guidance tool for people with/recovering from cancer

Intervention mapping [36]

Obtain consensus on the questions included in the guidance tool (a list of 43 questions was previously developed) and to which healthcare professional these should be asked, and test feasibility of the intervention to participants

A two-round Delphi study conducted online with 172 experts (round 1) and 139 experts (round 2); online survey to participants (n = 38) who tested the guideline tool for six weeks

The intervention was finalised by identifying the key components of the tool and a range of stakeholders and the tested in a feasibility study

Murchie et al. 2007 [37]

UK

Follow-up programme for people treated for cutaneous malignant melanoma

MRC framework 2000

Seek patients and GPs’ views on feasibility, desirability, benefits and components of the programme; assess feasibility and identify problems or deficiencies

Steering group consultations, semi-structured interviews with patients (n = 9) and GPs (n = 14), pre-pilot operationalisation exercise

The components of the intervention were identified, fine-tuned and the final intervention tested in a feasibility study

Palmer et al. 2013 [29]

UK

Nurse-led intervention for the outpatient management of incidentally diagnosed pulmonary embolism in cancer patients

MRC framework 2008

Real-time re-modelling, refinement and optimisation of the intervention to respond to problems and deviations arising in practice

Observations, audit and survey

The intervention processes and delivery were refined on the basis of the real-time re-modelling process’ results

Redfern et al. 2008 [36]

UK

The Stop Stroke intervention to improve risk factor management after stroke

MRC framework 2000

Achieve consensus about the factors which a novel intervention should address and how this might be delivered and test feasibility of intervention components to patients and healthcare professionals

Consensus process involving a study steering group (a team of multidisciplinary experts) and local clinicians, researchers and stroke survivors, semi-structure interviews with patients and healthcare professionals as part of the feasibility trial

The intervention components were identified, then the intervention was tested in a cluster RCT and parallel process evaluation

Robinson et al. 2005 [39]

UK

Intervention to facilitate coping skills in new carers of stroke patients

MRC framework 2000

Explore carers’ experiences of caring and their views on the proposed theoretical intervention, including the content, appropriateness and delivery of the intervention

One-to-one interviews with carers (n = 14), focus group with a subset of participants, interviews with carers that participated in the first course (n = 5), satisfaction questionnaire (n = 7)

Following analysis of the qualitative data, the theoretical outline of the course was refined

Schaefer et al. 2013 [49]

USA

Smoking cessation interventions

Not reported

Use simulations to estimate potential changes on the outcomes of interest and evaluate alternative intervention scenarios

Simulation algorithms to test peer influence on smoking and smoker popularity

Results demonstrated the potential impact of the behavioural intervention

Smith et al. 2012 [32]

UK

Intervention to reduce time to presentation with lung cancer symptoms

MRC framework 2008

Explore the theoretical intervention with GPs and patients

Interviews with lung cancer patients (n = 6), focus groups with people with lung cancer (n = 7), focus groups with GPs (n = 4), operational meetings with 2 GP practices

The study used the data from the focus groups and operational meetings to refine the intervention

Sturt et al. 2006 [38]

UK

The Self-Efficacy Goal Achievement (SEGA) nursing intervention for type 2 diabetes

MRC framework 2000

Explore intervention effectiveness, patients and healthcare professionals perspective of the intervention and establish the validity of any resulting changes to the intervention

Small uncontrolled trial of the intervention with 2 practice nurses and 8 participants (from 2 practices) and scenario testing

The intervention was adjusted to remove the less effective components and enhance the more effective ones

Treweek et al. 2014 [45]

UK

Interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections

Intervention modelling experiment

Explore and refine theory-based interventions before moving to a full-scale trial by evaluating the potential effect of the intervention on proxy outcomes that represent the actual behaviour

Exploratory RCT involving 270 GPs. GPs were asked to complete web-based clinical scenarios and questionnaire

Findings supported the use of intervention modelling experiments to reduce iterations of full-scale trial/analysis/revision before an optimised intervention is produced

Vonk Noordegraaf et al. 2012 [43]

Netherlands

eHealth intervention for the empowerment of gynaecological patients during the perioperative period to obtain timely return to work (RTW) and prevent work disability

Intervention Mapping

evaluate whether the intervention fitted the expectations of healthcare professionals and patients

Evaluation questionnaires completed by patients (n = 15), physicians (n = 11), eHealth specialists (n = 3) and patient representative (n = 1)

Minor adjustments were made on the basis of the findings

Whittaker et al. 2012 [47]

New Zealand

Mobile health intervention to prevent the onset of depression in adolescents (MEMO)

Process for the development and testing of mobile phone-based health interventions

Determine acceptability of the proposed intervention to target audience, improve and refine intervention on the basis of feedback

Online surveys involving students (n = 40), focus groups and individual interviews with adolescents

Results informed the development of the intervention

  1. aData not available at the time of this study was completed