Priorities for implementation research
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1 Leeds Institute of Health Sciences Priorities for implementation research Robbie Foy
2 1. Ensure rigour For example, in evaluating effectiveness
3 1. Ensure rigour The randomised trial is the worst form of evaluation, except for all the others
4 1. Ensure rigour The randomised trial is the worst form of evaluation, except for all the others Westworld, 1973
5 Mean scores for clinical quality at practice level for coronary heart disease, asthma, and type 2 diabetes, 1998 to Reproduced with permission from Campbell et al. N Engl J Med 2007;357: Brown, C. et al. BMJ 2008;337:a2764 Copyright 2008 BMJ Publishing Group Ltd.
6 Mean scores for clinical quality at practice level for coronary heart disease, asthma, and type 2 diabetes, 1998 to Reproduced with permission from Campbell et al. N Engl J Med 2007;357: Brown, C. et al. BMJ 2008;337:a2764 Copyright 2008 BMJ Publishing Group Ltd.
7 UK hospitals Appropriateness of transfusions Randomisation Enhanced Enhanced Enhanced Feedback content delivery content & as usual delivery Appropriateness of transfusions
8 2. Do real world research Foy R, Alderson S, Carder P, Clamp S, Farrin A, Glidewell L, Hartley S, Heyhoe J, Hulme C, Hunter C, Ingleson E, Johnson S, Lawton R, Louch G, McEachan R, Meads D, Petty D, Rathfelder M, Richardson J, Rushforth B, Stokes T, Ward V, West R, Watt I, Willis T
9 Implementation package 40 practices 40 practices Diabetes Intervention Control Risky prescribing Control Intervention Implementation package 32 practices 32 practices Hypertension Intervention Control Anticoagulation in atrial fibrillation Control Intervention
10 The PRagmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) wheel Kirsty Loudon et al. BMJ 2015;350:bmj.h by British Medical Journal Publishing Group
11 Recruitment How much extra effort is made to recruit participants over and above what would be used in the usual care setting to engage with patients? Opt-out recruitment of practices Patient groups identifiable via routinely electronic searches of routinely collected data 5
12 Follow-up How different is the intensity of measurement and follow-up of participants in the trial from the typical follow-up in usual care? Outcomes derived from remotely and routinely collected data 5
13 Eligibility Primary outcome 4 Follow-up 5 4 Flexibility: adherence Flexibility: delivery
14 3. Consider theory Offers a common language for identifying and exploring influences on practice Inherit the Wind, 1960 Enhances transparency in intervention development and description Provides a basis for evaluating mechanisms of action Informs subsequent scaling up and adaptation beyond research context
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16 Shaping knowledge Salience of consequences Feedback on behaviour Comparison of behaviour Goal setting Action planning Michie et al. Ann Behav Med 2013;46:81-95
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22 4. Think behaviours Relative advantage for the users Compatibility with personal and local norms Complexity Trialability the extent to which an innovation can be tried temporarily and discarded if found wanting Observability whether the expected results can be seen to be achieved easily Rogers E.M. Diffusion of Innovations. New York: Free Press; 1995
23 Associations between attributes of clinical practice recommendations and uptake MEDLINE EMBASE CINAHL EBM Reviews HMIC Databases Records identified through database searching (n = 2160 ) Records screened (n = 1635 ) Full-text articles assessed for eligibility (n = 103 ) De-duplication (n = 525 ) Records excluded: Not relevant, summaries of existing guidelines, guides on writing guidelines, attributes of clinicians (n = 1542 ) Full-text articles excluded Comparisons of guidelines to evidence, assessment of guideline awareness (n = 26 ) Studies included in synthesis (n = 77 ) Hypothesis generating (n = 72 ) Hypothesis testing (n = 5 ) Lord P, Grice A, Grimshaw J, Foy R
24 What we think is or should be associated with uptake (n=77) What is associated with uptake (n=5) Supported by strong evidence Concise / easy to follow Auditable Accessible Relates to daily practice Trustworthy authorship Includes feasibility/resource use Patient versions / formats Suits patients, meets their needs, preferences and expectations Supported by strong evidence Simple / specific Trialable X X X X Compatible with current norms / current practice Does not require routine / skills / organisation change
25 5. Consider complex contexts and needs Multiple priorities 100+ NICE guidelines potentially relevant to general practice recommendations Multi-morbidities 23% of primary care patients 65% of those over 65 years 82% of those aged 85 years or over Continuing re-disorganisation Growing service pressures within limited resources Rushforth et al. BMC Family Practice 2015;16:156 Barnett et al. Lancet 2012;380:37-43 Baird et al. King s Fund 2016
26 Ethnographic observations of depression screening Nurse: Are you alright, you haven t been having little interest in doing things, or? Patient: No, no. Nurse: Are you fine, are you okay? That s okay. Patient: It s been 10 years since I ve lost [wife]. Nurse: Is it, what, is that your wife? Patient: Yes. Nurse: 10 years? That s a long time, isn t it. Can I just check your tablets then, do you take aspirin, bendrofluazide Alderson SL, Russell AM, McLintock K, Potrata B, House A, Foy R. Incentivised case finding for depression in patients with chronic heart disease and diabetes in primary care: an ethnographic study. BMJ Open 2014;4:e005146
27 The Bouncer Rule
28 6. Curtail redundant research Chalmers I, Glasziou P; Lancet 2009; 374: 86 89
29 Audit and feedback Any summary of clinical performance of health care over a specified period of time. The summary may also have included recommendations for clinical action Cochrane EPOC definition
30 Growing Literature, Stagnant Science? Ivers et al. J Gen Intern Med 2014 DOI: /s y
31 7. and systematically advance intervention development Towards implementation laboratories which embed research within existing large-scale initiatives, e.g. national audit and feedback programmes Involve close partnerships between healthcare systems delivering implementation strategies at scale and research teams Ivers & Grimshaw. Lancet 2016; 388: 547-8
32 7. and systematically advance intervention development
33 7. and systematically advance intervention development Implementation laboratories potential for: Systematically identifying and addressing priorities Sequential head-to-head trials Developing good methodological practice Enhancing generalisability Demonstrating impact
34 8. Think economics Systematic review of rigorous evaluations of guideline implementation strategies 235 studies reporting 309 comparisons Cost-effectiveness analysis in only 11 comparisons The costs of some interventions may actually outweigh any potential benefits or anticipated cost savings of a change in practice Grimshaw et al. Health Technol Assess 2004; 8(6) Mason et al. JAMA 2001:
35 9. Think populations 35 general practices in Newcastle Randomisation Brief educational message Attached to lab test reports No message Patient outcomes and test ordering practice at 24 months Foy et al. Implementation Science 2011; 6: 129
36 9. Think populations Outcome data available from 2005 for 8,690 patients with diabetes from 32 practices BP message produced a statistically significant reduction in diastolic BP of 0.62 mmhg (95% CI to mmhg) Diastolic BP reduction approximated to a 5% relative reduction in stroke mortality and 3% to 4% falls in mortality from ischaemic heart disease and other vascular causes over 10 years Occurred in a top performing primary care trust
37 10. Design out the need for implementation research Fit Implementation effort
38 Priorities for implementation research 1. Ensure rigour 2. Do real world research 3. Consider theory 4. Think behaviours 5. Consider complex contexts and needs 6. Curtail redundant research 7. and systematically advance intervention development 8. Think economics 9. Think populations 10.Design out the need for implementation research
39 Acknowledgements This presentation summarises independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (Grant Reference Numbers RP-PG and RP-PG ) and Research for Patient Benefit Programme (RP- PG ) 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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