Research translation and implementation research

The process of translating research into therapeutic benefits for patients has been described in a five-stage model by the US National Institute of Health . Early translation phases (T1 and T2) focus on basic science, epidemiology and testing the efficacy of health interventions. The third translation phase or ‘T3’ encompasses research designed to increase implementation of evidence-based interventions, practices or policies . In understanding this model, it is essential to differentiate the act of implementation itself from research designed to inform implementation. Implementation itself is the use of strategies to increase the use, uptake, adoption or integration of health interventions, to change practice patterns within specific settings . Implementation research is the study of those ‘implementation strategies’, designed to integrate evidence, increase the use or adoption of policy, or change practice (i.e. achieve successful ‘implementation’) . Implementation research that assesses and compares implementation strategies provides an empirical basis to guide decisions of how to best improve the implementation of clinical guidelines. It is also important to note that implementation research comes with its own set of outcomes, which are distinct from clinical outcomes. Typical outcomes assessed in trials for implementation strategies include, clinician adherence to recommended treatment approaches and rates of (appropriate or inappropriate) referral for medical tests.

The National Institute of Health highlights implementation research as a fundamental component of research translation and a necessary pre-requisite for research to yield health improvements . In the back pain field, dedicated implementation research is required to improve the quality of care provided to patients and reduce the global impact of the condition by maximising the translation of guideline recommendations and research findings. In this paper we (a) discuss implementation models and approaches, (b) discuss the important features of implementation research and (c) critically appraise the quality of implementation research in the low back pain field, including a summary of what implementation strategies have been found to be effective. We conclude with recommendations for the design and conduct of future implementation studies in the field.

Implementation models, theories and frameworks

Implementation science is an emerging field of research. The field draws on a number of theoretical models and frameworks to guide the approach, selection of implementation strategies and methods of evaluation. As synthesized in a recent taxonomy, there are numerous implementation models, theories and frameworks that aim to (a) describe and/or guide the process of translating research into practice (process models), (b) understand and/or explain what influences implementation outcomes (determinant frameworks, classic theories and implementation theories) and (c) evaluate implementation strategies (evaluation frameworks) . The taxonomy of approaches by Nilsen provides an opportunity to facilitate consistency and comparability between studies, examples of which are described below

• a)
  

  Guiding translation

Important features of implementation research: improving the quality and efficiency

As a scientific discipline, implementation science is in its relative infancy. For example, just 2% of systematic reviews of health interventions report the findings of implementation trials . Furthermore, the quality of implementation research has been criticised . Implementation trials should possess the same methodological attributes considered to increase internal validity, such as those outlined by Medical Research Council guidance . For example, for the purposes of testing implementation intervention effectiveness, randomised controlled trials (RCTs) have lower risk of bias than other research designs. Concealed allocation and masking where possible are appropriate. This is because the same risks of bias apparent in the research of patient-level treatments apply to implementation research. Just as there are reporting guidelines such as CONSORT to improve the clarity and consistency of RCTs, a reporting guideline has been recently been released for implementation studies. Preparation of study reports according to the Standards for Reporting Implementation studies of complex interventions (StaRI) guidelines will help generate an interpretable and comparable evidence base in the area.

There are, however, several additional considerations important in the design, conduct and reporting of implementation research. We propose three particular areas of consideration: theoretically informed development of implementation strategies that target identified barriers and enablers, categorisation of implementation strategies using standardised terminology, and evaluating the effectiveness on individual and implementation outcomes and on the cost of intervention delivery and adverse events. Close attention to these issues has the potential to advance the science of implementation.

• a)
  

  Appropriate intervention development including use of theory or empirical evidence to address identified barriers and enablers

It is recommended that the development of implementation interventions should be guided by an appropriate theory or implementation framework such as those described above. Recognising the inherent complexity in implementing best practice, formative evaluation to appropriately identify and consider questions about context and barriers to change is required to guide any implementation approach. The use of theory or implementation frameworks helps ensure that researchers consider relevant barriers and enablers in the design of implementation strategies. This application of theory or conceptual models in the design of implementation strategies can make explicit the mechanism(s) by which implementation strategies are hypothesised to work, enabling researchers to identify both if and how implementation strategies may improve practice. The importance of their use is supported by findings of systematic reviews, which suggest that the application of such theory and frameworks is associated with more effective implementation . Among the most comprehensive is the TDF, as described above, which has been applied in the development of successful interventions to improve clinical practice.

• b)
  

  Categorisation of implementation strategies using standard terminology

Inconsistent use of terminology is a problem for implementation science as it obstructs attempts to synthesise and understand implementation processes and outcomes . A number of attempts have been made to consolidate and standardise terminology. Of particular importance is the use of taxonomies in the description of implementation strategies. Among the most popular include the intervention taxonomy (ITAX) and the Effective Practice and Organisation of Care (EPOC) taxonomy . ITAX provides a comprehensive description of the features of implementation strategies, including the mode of delivery, schedule, adaptability and other characteristics . The EPOC taxonomy has been designed to help describe and categorise health system interventions . The EPOC taxonomy was recently updated to ensure greater alignment with other taxonomies used to classify health system interventions, and it includes four major domains: delivery arrangements, financial arrangements, governance arrangements and implementation strategies . While it is primarily used to assist the classification and synthesis of implementation strategies in systematic reviews, the taxonomy also provides researchers with terminology to describe implementation strategies in individual trials .

• c)
  

  Appropriate outcomes for implementation research: individual, implementation, cost and adverse events

While the process of research translation typically involves the use or adoption of known effective treatments in routine care, assessment of both implementation and patient outcomes are essential in implementation trials. This is to understand whether selected implementation strategies influence the use of the targeted treatment or practice and whether such practice changes in turn affect patient outcomes. For example, an implementation strategy may be effective in improving implementation outcomes but not affect patient outcomes because of natural adaptions in the delivery of the treatment in routine care. Arguably, such understanding is necessary to avert continued implementation and investment in policy or practice that does not affect real-world patient outcomes.

Implementation strategies can also cause harm. For example, the introduction of new interventions into clinical systems can displace other important clinical practices, or incorrect implementation could increase the risk of adverse patient outcomes. Policy-makers and practitioners need to weigh the benefits of implementation of effective interventions with potential unintended harms when making decisions regarding therapeutic intervention or health service investment. As such, evaluation of implementation strategies should include evaluation of both benefits and harms. The cost of implementation is also a fundamental consideration for health services that need to manage finite resources. A recent review of 91 systematic reviews in primary care to improve the implementation of complex interventions concluded that evidence on cost-effectiveness was limited and reporting on costs was scarce and of low quality. Reporting of cost data, or formal cost analyses, as part of trials of implementation strategies would help fill this gap.

Critical appraisal of implementation studies in low back pain

We searched the Cochrane library and PubMed [using the search terms (‘low back pain’ OR ‘musculoskeletal conditions’) AND ‘implementation’ AND ‘review’)] to identify reviews that assessed the effectiveness of implementation strategies to improve the implementation of low back pain care. We then summarised and appraised the individual studies included in the reviews according to methods (attention to the three important features of implementation research outlined above and risk of bias assessment) and content (which implementation strategies are effective).

Characteristics of individual studies

Twenty-one unique trials were included in the five identified systematic reviews (see Table 4 ). Three studies were excluded because they did not report an explicit implementation strategy. One study aimed to improve the implementation of low back pain care guidelines but did not include an implementation strategy and two studies assessed the publication of guidelines without the addition of active implementation strategies . Collectively, these excluded studies provide some evidence that passive dissemination of guidelines is not effective in changing practice .

Table 4

Characteristics of individual implementation studies to improve low back pain care.

Study/Year/Country	Study characteristics	Study quality risk of bias implementation study quality criteria	Study findings
Baker 1987, USA	Study design: Interrupted time series; Participants: number of providers not reported. number of tests 1443 in control year and 759 in experimental year; Setting: Hospital; • Intervention: Reminder: note on X-ray referral form; Implementation outcomes: Number of emergency lumbosacral spine examinations, use of lumbosacral spine radiography, percentage compliance with limited indications form. Patient outcomes: None.	Overall: Low Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Empirical evidence informed intervention: NR Taxonomy used to describe implementation strategies: NR Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	The intervention was more effective than control on the use of lumbosacral spine radiography.
Becker 2008, Germany	Study design: C-RCT Participants: 126 GPs from 118 practices, 1378 participants; Setting: Primary care Intervention: • Intervention 1: Distribution of low back pain guidelines, interactive seminars, individual academic detailing sessions, patient leaflets (educational material + outreach visits + educational meetings); • Intervention 2: Distribution of low back pain guidelines, interactive seminars, individual academic detailing sessions, patient leaflets (educational material + outreach visits + educational meetings), motivational counselling session for GPs, training for practice nurses, patient counselling sessions; • Comparison: Distribution of guidelines on low back pain (educational material). Patient outcomes: Functional capacity, physical activity, days in pain, days of sick leave, quality of life and fear avoidance beliefs.	Sequence generation: Low Allocation concealment: Low Blinding of participants: NR Blinding of outcome assessment: Low Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: Low/Unclear Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies. Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence cited from two systematic reviews. Implementation outcomes: NR Patient outcomes: Yes Cost analysis: Yes (reported separately) Adverse events: NR	Intervention 2 was more effective than control on functional capacity at 6 months, but not 12 months. Intervention 1 was not effective on functional capacity at 6 months or 12 months. Intervention 1 and 2 were effective on the number of pain days at 6 and 12 months.
Bekkering 2005, The Netherlands	Study design: C-RCT Participants: 113 physiotherapists Setting: Primary care physiotherapy practices • Intervention: Group training sessions, postal dissemination of guidelines and education material; • Comparison: Postal dissemination of guidelines and educational material. Implementation outcomes: Adherence to recommended treatment approaches Patient outcomes: Physical function, pain, sick leave.	Overall: Low Theoretically informed intervention: Yes – Grol 1994 Intervention targeted identified barriers/enablers: Yes – previous studies and previous survey of Dutch physiotherapists Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence Implementation outcomes: Yes Patient outcomes: Yes Cost analysis: NR Adverse events: NR	The intervention was more effective than the comparison in limiting physiotherapist treatment sessions for patients with normal course of back pain, setting functional treatment goals, using mainly active interventions, giving adequate patient education and adhering to recommended treatment approach criteria. Physical functioning and pain in the two groups improved substantially in the first 12 weeks; however, no difference was found between the intervention and comparison groups at follow-up.
Bishop 2006, Canada	Study design: RCT Participants: 462 GPs, 428 patients Setting: Primary care Intervention: • Intervention 1: Distribution of educational materials to GP, reminders; • Intervention 2: Distribution of educational materials to GP and patient, reminders to GP and patient; Comparison: usual care Implementation outcomes: Concordance with specific clinical guidelines-derived history-taking items, physical examination procedures and treatment recommendations. Patient outcomes: None.	Sequence generation: Low Allocation concealment: High Blinding of participants: NR Blinding of outcome assessment: Unclear Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: Unclear Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	The intervention was more effective than usual care in guideline-concordant treatments of prolonged bed rest, passive therapies and recommendations for aerobic exercise.
Dey 2004, UK	Study design: C-RCT Participants: 24 practices, 2187 patients Setting: Primary care • Intervention: Educational outreach visit + guidelines (educational material) + poster of guidelines + referral forms with guidelines + access to fast-track physiotherapy and a back clinic. • Comparison: Standard practice. Implementation outcomes: Rate of referral for lumbar spine X-ray within 3 months, number of sickness certificates issues, number of prescribed opioids or muscle relaxants, number referred to secondary care, number referred to physiotherapy or educational programme. Patient outcomes: None.	Sequence generation: Low Allocation concealment: Low Blinding of participants: NR Blinding of outcome assessment: High Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: Low Theoretically informed intervention: Yes – ‘elaboration likelihood model of persuasion’ was used in part to inform the intervention Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	The intervention was more effective than standard practice in referring patients to physiotherapy or a back pain unit. There was no effect of the intervention on the proportion of patients referred for X-ray, issued with a sickness certificate, prescribed opioids or muscle relaxants or referred to secondary care.
Eccles 2001, UK	Study design: C-RCT (2 × 2 factorial design) Participants: General practitioners from 247 practices Setting: Primary care Intervention: • Intervention 1: Distribution of educational materials + audit and feedback (number of practice referrals compared with peers; • Intervention 2: Distribution of education materials + reminders (messages on X-ray results); • Intervention 3: Distribution of educational materials + audit and feedback + reminders; Comparison: • Control group: Distribution of educational materials (guideline). Implementation outcomes: Number of lumbar radiographs requested per 1000 patients for 2 years. Patient outcomes: None.	Sequence generation: Low Allocation concealment: Low Blinding of participants: NR Blinding of outcome assessment: Low Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: Unclear Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence cited for specific prompts at time of consultation and audit and feedback Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	The intervention of routine attachment of educational reminder messages on X-ray results was more effective than control in reducing the request rate of lumbar radiographs. No effect of a 6 monthly feedback of audit data intervention on reducing the request rate of lumbar radiographs.
Engers 2005, The Netherlands	Study design: C-RCT Participants: 41 GPs, 531 patients Setting: Primary care • Intervention: 2-h workshop (negotiation skills), guideline on low back pain and guidance on low back pain for occupational physicians, 2 scientific articles, a patient education tool and a management decision tool (distribution of educational materials). • Comparison: No intervention, usual care Implementation outcomes: Number of referrals to a therapist (physical, exercise or manual therapist), prescription of pain medication on a time-contingent basis, prescription of paracetamol versus NSAIDs, adequacy of patient education. Patient outcomes: None.	Sequence generation: Low Allocation concealment: High Blinding of participants: NR Blinding of outcome assessment: High Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: High Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies cited Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence cited for distribution of the guideline for occupational physicians and scientific articles concerning GP management of nonspecific low back pain. Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	No effect of the intervention of advice and education provided; prescription of paracetamol or NSAIDs; or the overall number of referrals to physical therapist, exercise therapist or manual therapist.
French 2013, Australia	Study design: C-RCT Participants: 78 practices, 92 GPs Setting: Primary care • Intervention: 2 facilitated interactive educational workshops aiming to facilitate behaviour change plus distribution of educational DVDs to all physicians; • Comparison: Usual care; Implementation outcomes: GP reported behavioural change and number of X-ray and CT requests. Patient outcomes: Planned, but not measured because of low numbers of patients recruited.	Sequence generation: Low Allocation concealment: Low Blinding of participants: NR Blinding of outcome assessment: Low Incomplete outcome data: High Selective outcome reporting: High Other risk of bias: High Theoretically informed intervention: Yes, Theoretical Domains Framework Intervention targeted identified barriers/enablers: Yes – focus group interviews with GPs Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – strategies selected using a mapping tool Implementation outcomes: Yes Patient outcomes: No Cost analysis: Yes Adverse events: NR	The intervention was more effective than usual care in the GP’s intention of practising consistency with the guidelines for the clinical behaviour of X-ray referral, GPs adherence to guideline recommendations about X-ray and advice to stay active. There was no effect of the intervention on imaging referral.
Goldberg 2001, USA	Study design: RCT Participants: Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators Setting: Entire communities • Intervention: Surgeon study group meetings, use of local opinion leaders, GP education sessions, printed educational materials, audit, patient educational materials, financial data analysis meetings; • Comparison: Usual care Implementation outcomes: Surgical procedures carried out from the Comprehensive Hospital Reporting System. Patient outcomes: None	Overall: High Sequence generation: High Allocation concealment: Unclear Blinding of participants: Unclear Blinding of outcome assessment: Unclear Incomplete outcome data: High Selective outcome reporting: Low Other risk of bias: Low Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies cited and consultation with clinicians and administrators. Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: No Cost analysis: Yes (reported intervention cost) Adverse events: NR	The intervention was effective in reducing surgical rates compared to usual care.
Hazard 1997, USA	Study design: RCT Participants: 59 patients Setting: primary care • Intervention: Distribution of educational materials + reminders to GPs (letters regarding the specific patient with advice on how to limit work loss); • Comparison: Control Implementation outcomes: Influence of care following information provision; Patient outcomes: 3-month work absence rate, disability (VDPQ score), satisfaction with health care, impact of health care on return to work, days of work loss, days until first return to work.	Sequence generation: Low Allocation concealment: High Blinding of participants: NR Blinding of outcome assessment: High Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: Unclear Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: Yes Cost analysis: NR Adverse events: NR	No effect of the intervention on 3-month work absence rate, pain, satisfaction with health care, impact of health care on return to work, days or work loss, or days until first return to work.
Kerry 2000, UK	Study design: C-RCT Participants: 69 practices, 175 GPs, 43,778 radiological requests; Setting: Primary care • Intervention: Distribution of guidelines + individual feedback on referral rates + graph of the average radiation dose for different examinations (educational material and audit/feedback); • Comparison: Standard care. Implementation outcomes: number of X-ray requests (chest, limbs and joints, spine) within 12 months; Patient outcomes: None	Sequence generation: Low Allocation concealment: Unclear Blinding of participants: NR Blinding of outcome assessment: Low Incomplete outcome data: Low Selective outcome reporting: High Other risk of bias: Low Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies citing GP lack of guidelines knowledge. Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical (conflicting) evidence cited for end-user involvement in guideline development. Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	No intervention effect on the total number of X-ray requests. Practices that followed the guidelines requested significantly fewer spinal examinations than standard practice.
Matowe 2002, UK	Study design: Interrupted time series Participants: Number of practices and providers not reported. Analysis included 117,747 imaging requests; Setting: Primary care • Intervention: Professional intervention (distribution of educational materials) Implementation outcomes: Number of X-ray referrals Patient outcomes: None	Overall: Low Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	There were no significant effects of the intervention on the total number of requests or requests for individual examinations.
Oakeshott 1994, UK	Study design: C-RCT Participants: 62 practices, analysis was of 2578 X-ray examinations Setting: Primary care • Intervention: Professional intervention (distribution of educational materials) • Comparison: Control (not specified) Implementation outcomes: number of radiology requests within 9 weeks, percentage of radiology requests that confirm to guidelines; Patient outcomes: None.	Sequence generation: Unclear Allocation concealment: Unclear Blinding of participants: NR Blinding of outcome assessment: Low Incomplete outcome data: Low Selective outcome reporting: Unclear Other risk of bias: Low Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	Practices that received the guidelines requested significantly fewer spinal examinations and made significantly higher proportion of requests than those that did not. No intervention effects on the proportion of forms giving physical findings or the proportion of positive findings in radiology.
Robling 2002, UK	Study design: C-RCT Participants: 30 practices, 182 MRI requests Setting: Primary care • Intervention 1: Professional intervention (distribution of educational materials + educational meetings, practice based); • Intervention 2. Professional intervention (audit and feedback); • Intervention 3. Professional intervention (1 + 2); • Comparison: Distribution of educational materials. Implementation outcomes: proportion of MRI requests that are in concordance with guideline (length of follow-up not clear); Patient outcomes: None	Sequence generation: Low Allocation concealment: Unclear Blinding of participants: NR Blinding of outcome assessment: Unclear Incomplete outcome data: Unclear Selective outcome reporting: Unclear Other risk of bias: Unclear Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence cited for GP education Implementation outcomes: Yes Patient outcomes: NR Cost analysis: Yes – intervention cost Adverse events: NR	No significant differences were found between the four intervention groups in the proportion of MRI requests, which are in concordance with guidelines.
Rossignol 2000, Canada	Study design: RCT Participants: 110 patients Setting: Primary care • Intervention: Organisational intervention (clinical multidisciplinary team) • Comparison: Usual care Implementation outcomes: proportion of patients who received lumbar imaging (X-ray, CT, MRI or myelogram) within 6 months; Patient outcomes: return to work; function; health care consumption; satisfaction.	Sequence generation: Low Allocation concealment: Unclear Blinding of participants: NR Blinding of outcome assessment: Low Incomplete outcome data: Unclear Selective outcome reporting: Unclear Other risk of bias: High Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: Yes Cost analysis: NR Adverse events: NR	The intervention group used significantly less specialised imaging tests of the spine at 6 months than control. At 6 month follow-up, there was no effect of the intervention on return to work; however, there was evidence of an intervention effect on 3 of 5 functional recovery outcomes compared to usual care.
Schectman 2003, USA	Study design: C-RCT Participants: 85 physicians, 2020 patients, 14 group practice sites Setting: Primary care • Intervention 1. Distribution of guidelines on the management of acute low back pain + educational meeting + feedback on back pain encounters + individual follow-up visit by investigator 6 months afterwards and another feedback on back encounters + educational material for patients including a videotape (educational material + meeting + audit + outreach); • Intervention 2. Education materials for patients: pamphlet and video. Two reminders within the first 3 months to clinicians to use these materials (educational material); • Intervention 3.1 + 2; • Comparison: Control group; Implementation outcomes: Proportion of lumbar plain X-ray, CT or MRI consistent with guideline within 12 months, Subspecialty referral, Physiotherapy referral; Patient outcomes: Beliefs about care, satisfaction with care, clinical outcome measures using validated instruments.	Sequence generation: Unclear Allocation concealment: Low Blinding of participants: NR Blinding of outcome assessment: Unclear Incomplete outcome data: Unclear Selective outcome reporting: Unclear Other risk of bias: High Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies Taxonomy used to describe implementation strategies: NR Evidence informed intervention: NR Implementation outcomes: Yes Patient outcomes: Yes Cost analysis: NR Adverse events: NR	Intervention 1 (clinician intervention) was effective in increasing guideline-consistent behaviour compared to control. There was no effect of intervention 2 on guideline-consistent behaviour compared to control.
Stevenson 2006, UK	Study design: C-RCT Participants: 30 physiotherapists Setting: Primary care • Intervention: 5-h education session delivered by a local opinion leader; • Comparison: Standard in-service session on knee pathologies; Implementation outcomes: Change in physiotherapists’ clinical practice (discharge summary questionnaire); Patient outcomes: None.	Overall: High Sequence generation: Unclear Allocation concealment: Unclear Blinding of participants: Low Blinding of outcome assessment: Low Incomplete outcome data: Low Selective outcome reporting: Low Other risk of bias: High Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: Yes – previous studies cited. Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence cited for continual medical education, printed educational material, feedback, clinical guidelines and use of opinion leaders. Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	The intervention group was more likely than the control group physiotherapists to give ‘advice to increase activity level’ and ‘change attitudes/beliefs about pain’ but was less likely to ‘encourage to undertake activities themselves’. The control group was significantly more likely to ‘use acupuncture’, ‘encourage to undertake activities themselves’ and ‘receive postural advice’ compared with the intervention group.
Winkens 1995, The Netherlands	Study design: C-RCT Participants: 79 providers Setting: Primary care • Intervention: Professional intervention (audit and feedback for one set of tests); • Comparison: No intervention control Implementation outcomes: number of diagnostic tests ordered within 2 years; diagnostic tests concordant with guideline; Patient outcomes: None.	Sequence generation: Unclear Allocation concealment: Unclear Blinding of participants: NR Blinding of outcome assessment: Unclear Incomplete outcome data: Unclear Selective outcome reporting: Unclear Other risk of bias: Unclear Theoretically informed intervention: NR Intervention targeted identified barriers/enablers: NR Taxonomy used to describe implementation strategies: NR Empirical evidence informed intervention: Yes – empirical evidence cited for GP feedback Implementation outcomes: Yes Patient outcomes: NR Cost analysis: NR Adverse events: NR	The intervention was effective in decreasing the proportion of non-rational requests compared to control.

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