Process evaluations in neurological rehabilitation: a mixed-evidence systematic review and recommendations for future research

Journal article


Masterson-Algar, P., Burton, C. and Rycroft-Malone, J. 2016. Process evaluations in neurological rehabilitation: a mixed-evidence systematic review and recommendations for future research. BMJ Open. 6 (11). https://doi.org/10.1136/bmjopen-2016-013002
AuthorsMasterson-Algar, P., Burton, C. and Rycroft-Malone, J.
Abstract

Objective: To systematically review how process evaluations are currently designed, what methodologies are used and how are they developed alongside or within neurological rehabilitation trials.

Methods: This mixed-methods systematic review had two evidence streams: stream I, studies reporting process evaluations alongside neurorehabilitation trials research and stream II, methodological guidance on process evaluation design and methodology. A search strategy was designed for each evidence stream. Data regarding process evaluation core concepts and design issues were extracted using a bespoke template. Evidence from both streams was analysed separately and then synthesised in a final overarching synthesis proposing a number of recommendations for future research.

Results: A total of 124 process evaluation studies, reporting on 106 interventions, were included in stream I evidence. 30 studies were included as stream II evidence. Synthesis 1 produced 9 themes, and synthesis 2 identified a total of 8 recommendations for process evaluation research. The overall synthesis resulted in 57 ‘synthesis recommendations’ about process evaluation methodology grouped into 9 research areas, including the use of theory, the investigation of context, intervention staff characteristics and the delivery of the trial intervention.

Conclusions: There remains no consensus regarding process evaluation terminology within the neurological rehabilitation field. There is a need for process evaluations to address the nature and influence of context over time. Process evaluations should clearly describe what intervention staff bring to a trial, including skills and experience prior to joining the research. Process evaluations should monitor intervention staff's learning effects and the possible impact that these may have on trial outcomes.

KeywordsNeurological rehabiliation; Process evaluations; Systematic review
Year2016
JournalBMJ Open
Journal citation6 (11)
PublisherBMJ Publishing Group
ISSN2044-6055
Digital Object Identifier (DOI)https://doi.org/10.1136/bmjopen-2016-013002
Official URLhttp://dx.doi.org/10.1136/bmjopen-2016-013002
Publication dates
Online08 Nov 2016
Publication process dates
Deposited26 May 2020
Output statusPublished
References

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Brocklehurst, P., Hoare, Z., Woods, C., Williams, L., Brand, A., Shen, J., Breckons, M., Ashley, J., Jenkins, A., Gough, Lesley, Preshaw, P., Burton, C., Shepherd, Karen and Bhattarai, N. 2021. Dental therapists compared with general dental practitioners for undertaking check-ups in low-risk patients: pilot RCT with realist evaluation. Health Services and Delivery Research. 9 (3), pp. 1-118. https://doi.org/10.3310/hsdr09030
Making authentic: exploring boundary objects and bricolage in knowledge mobilisation through National Health Service-university partnerships
Melville-Richards, Lucy, Rycroft-Malone, Joanne, Burton, Christopher and Wilkinson, Joyce 2020. Making authentic: exploring boundary objects and bricolage in knowledge mobilisation through National Health Service-university partnerships. Evidence & Policy: A Journal of Research, Debate and Practice. 16 (4), pp. 517-539. https://doi.org/10.1332/174426419x15623134271106
A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial
Sackley, C. M., Rick, C., Au, P., Brady, M. C., Beaton, G., Burton, C., Caulfield, M., Dickson, S., Dowling, F., Hughes, M., Ives, N., Jowett, S., Masterton-Algar, P., Nicoll, A., Patel, S., Smith, C. H., Woolley, R. and Clarke, C. E. 2020. A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial. Trials. 21 (436). https://doi.org/10.1186/s13063-020-04354-7
'Function first—be active, stay independent’—Promoting physical activity and physical function in people with long-term conditions by primary care: a protocol for a realist synthesis with embedded co-production and co-design
Law, R-J, Williams, L., Langley, J., Burton, C., Hall, B., Hiscock, J., Morrison, V., Lemmey, A., Partridge, R., Lovell-Smith, C., Gallanders, J. and Williams, N. 2020. 'Function first—be active, stay independent’—Promoting physical activity and physical function in people with long-term conditions by primary care: a protocol for a realist synthesis with embedded co-production and co-design. BMJ Open. 10 (2). https://doi.org/10.1136/bmjopen-2019-035686
Implementation, impact and costs of policies for safe staffing in acute NHS trusts
Ball, J., Barker, H., Burton, C., Crouch, R., Griffith, P., Jones, J. and Rycroft Malone, J. 2019. Implementation, impact and costs of policies for safe staffing in acute NHS trusts. University of Southampton. https://doi.org/10.5258/SOTON/P0012
Sleep hygiene education and children with developmental disabilities: Findings from a co-design study
Sutton, J.E., Huws, J.C. and Burton, C. 2019. Sleep hygiene education and children with developmental disabilities: Findings from a co-design study. Journal of Intellectual Disabilities. https://doi.org/10.1177/1744629518818950
Towards safe nurse staffing in England’s National Health Service: progress and pitfalls of policy evolution
Lawless, J., Couch, R., Griffiths, P., Burton, C. and Ball, J. 2019. Towards safe nurse staffing in England’s National Health Service: progress and pitfalls of policy evolution. Health Policy. 123 (6), pp. 590-594. https://doi.org/10.1016/j.healthpol.2019.03.011
Brief smoking cessation in acute Welsh hospitals: A realist approach
Davies, S., Burton, C., Williams, L. and Tinkler, A. 2019. Brief smoking cessation in acute Welsh hospitals: A realist approach. Health Promotion International. 35 (2), pp. 244-254. https://doi.org/10.1093/heapro/daz020
Understanding how and why de-implementation works in health and care: research protocol for a realist synthesis of evidence
Burton, C., Williams, L., Bucknall, T., Edwards, S., Fisher, D., Hall, B., Harris, G., Jones, P., Makin, M., McBride, A., Meacock, R., Parkinson, J., Rycroft-Malone, J. and Waring, J. 2019. Understanding how and why de-implementation works in health and care: research protocol for a realist synthesis of evidence. Systematic Reviews. 8 (194). https://doi.org/doi.org10.1186/s13643-019-1111-8
NHS managers’ use of nursing workforce planning and deployment technologies: a realist synthesis
Burton, C., Rycroft-Malone, J., Williams, L., Davies, S., McBride, A., Hall, B., Rowlands, A., Jones, A., Fisher, D., Jones, M. and Caulfield, M. 2018. NHS managers’ use of nursing workforce planning and deployment technologies: a realist synthesis. Health Services and Delivery Research. 6 (36). https://doi.org/10.3310/hsdr06360
The generation of consensus guidelines for carrying out process evaluations in rehabilitation research
Masterson-Algar, P., Burton, C. and Rycroft-Malone, J. 2018. The generation of consensus guidelines for carrying out process evaluations in rehabilitation research. BMC Medical Research Methodology. 18 (1), pp. 1-11. https://doi.org/10.1186/s12874-018-0647-y
Getting back to life after stroke: co-designing a peer-led coaching intervention to enable stroke survivors to rebuild a meaningful life after stroke
Masterson-Algar, P., Williams, S., Burton, C., Arthur, C., Hoare, Z., Morrison, V., Radford, K., Seddon, D. and Elghenzai, S. 2018. Getting back to life after stroke: co-designing a peer-led coaching intervention to enable stroke survivors to rebuild a meaningful life after stroke. Disability and Rehabilitation. 42 (10), pp. 1359-1372.
Arts-based palliative care training, education and staff development: A scoping review
Turton, B.M., Williams, S., Burton, C.R. and Williams, L. 2018. Arts-based palliative care training, education and staff development: A scoping review. Palliative Medicine. 32 (2). https://doi.org/10.1177/0269216317712189
The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.
Masterson-Algar, P, Burton, C., Brady, M.C., Nicoll, A., Clarke, C.E., Rick, C., Hughes, M., Au, P., Smith, C.H. and Sackley, C.M. 2017. The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease. Trials. 18 (397), p. 2017. https://doi.org/10.1186/s13063-017-2130-1
Managing diabetes in people with dementia: a realist review
Bunn, F., Goodman, C., Jones, P.R., Russell, B., Trivedi, D., Sinclair, A., Bayer, A., Rait, G., Rycroft-Malone, J. and Burton, C. 2017. Managing diabetes in people with dementia: a realist review. Perth, Scotland NIHR Journals Library. https://doi.org/10.3310/hta21750
Implementation and trial evidence: a plea for fore-thought
Brocklehurst, P.R., Williams, L., Burton, C., Goodwin, T. and Rycroft-Malone, J. 2017. Implementation and trial evidence: a plea for fore-thought. British Dental Journal. 222 (5), pp. 331-335. https://doi.org/10.1038/sj.bdj.2017.213
What works for whom in the management of diabetes in people living with dementia: a realist review
Bunn, F., Goodman, C., Jones, P. R., Russell, B., Trivedi, D., Sinclair, A., Bayer, A., Rait, G., Rycroft-Malone, J. and Burton, C. 2017. What works for whom in the management of diabetes in people living with dementia: a realist review. BMC Medicine. 15 (141). https://doi.org/10.1186/s12916-017-0909-2
Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions
Rycroft-Malone, J., Burton, C., Williams, L., Edwards, S., Fisher, D., Hall, B., McCormack, B., Nutley, S., Seddon, D. and Williams, R. 2016. Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions. National Institute of Health Research. https://doi.org/10.3310/hsdr04120
Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke
French, B., Thomas, L.H., Harrison, J., Burton, C., Forshaw, D., Booth, J., Britt, D., Cheater, F.M., Roe, B. and Watkins, C.L. 2016. Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke. Qualitative Health Research. 26 (10). https://doi.org/10.1177/1049732316630975
Implementing best practice in infection prevention and control. A realist evaluation of the role of intermediaries
Williams, L., Rycroft-Malone, J. and Burton, C. 2016. Implementing best practice in infection prevention and control. A realist evaluation of the role of intermediaries. International Journal of Nursing Studies. 60, pp. 156-167. https://doi.org/10.1016/j.ijnurstu.2016.04.012
Bringing critical realism to nursing practice: Roy Bhaskar's contribution
Williams, L., Rycroft-Malone, J. and Burton, C. 2016. Bringing critical realism to nursing practice: Roy Bhaskar's contribution. nursing philosophy: an international journal for healthcare professionals. 18 (2). https://doi.org/10.1111/nup.12130
Managers' use of nursing workforce planning and deployment technologies: protocol for a realist synthesis of implementation and impact
Burton, C., Rycroft-Malone, J., Williams, L., Davies, S., McBride, A., Hall, B., Rowlands, A.M. and Jones, A. 2016. Managers' use of nursing workforce planning and deployment technologies: protocol for a realist synthesis of implementation and impact. BMJ Open. 6 (8). https://doi.org/10.1136/bmjopen-2016-013645
Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions
Williams, L., Rycroft-Malone, J., Burton, C., Edwards,S., Fisher, D., Hall, B., McCormack, B., Nutley, S.M., Seddon, D. and Williams, R. 2016. Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions. BMJ Open. 6 (8). https://doi.org/10.1136/bmjopen-2016-011964
Strategies to prevent oral disease in dependent older people
Brocklehurst, P., Williams, L., Hoare, Z., Goodwin, T., McKenna, G., Tsakos, G., Chestnutt, I.G., Pretty, I., Wassall, R., Jerkovic-Cosic, K., Hayes, M., Watt, R.G. and Burton, C. 2016. Strategies to prevent oral disease in dependent older people. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.CD012402
Managing diabetes in people with dementia: protocol for a realist review
Bunn, F., Goodman, C., Rycroft Malone, J., Reece Jones, P., Burton, C., Rait, G., Trivedi, D., Bayer, A. and Sinclair, A. 2016. Managing diabetes in people with dementia: protocol for a realist review. Systematic Reviews. 5 (5). https://doi.org/10.1186/s13643-015-0182-4
Collaboration and co-production knowledge in healthcare: opportunities and challenges
Rycroft-Malone, J., Burton, C.R., Bucknall , T., Graham, I.D., Hutchinson, A. and Stacey, D. 2016. Collaboration and co-production knowledge in healthcare: opportunities and challenges. International Journal of Health Policy and Management. 5 (4), pp. 221-223. https://doi.org/10.15171/IJHPM.2016.08
Collective action for implementation: a realist evaluation of organisational collaboration in healthcare
Rycroft-Malone, J., Burton, C.R., Wilkinson, J., Harvey, G., McCormack, B., Baker, R., Dopson, S., Graham, I.D., Staniszewska, S., Thompson, C., Ariss, S., Melville-Richards, L. and Williams , L. 2016. Collective action for implementation: a realist evaluation of organisational collaboration in healthcare. Implementation Science : IS. 11 (17). https://doi.org/10.1186/s13012-016-0380-z
An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH): cluster randomised controlled trial with economic evaluation
Sackley, C.M., Walker, M.F., Burton, C.R., Watkins,C.L, Mant, J., Roalfe, A.K., Wheatley, K., Sheehan, B., Sharp, L., Stant, K.E., Fletcher-Smith, J., Steel, K., Barton, G.R., Irvine, L. and Peryer, G. 2016. An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH): cluster randomised controlled trial with economic evaluation. Health Technology Assessment. 20 (15). https://doi.org/10.3310/hta20150
Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care
Thomas, L. H., French, B., Sutton, C. J., Forshaw, D., Leathley, M. J., Burton, C., Roe, B., Cheater, F. M., Booth, J., McColl, E., Carter, B., Walker, A., Brittain, K., Whiteley, G., Rodgers, H., Barrett, J. and Watkins, C. L. 2015. Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care. NIHR Journals Library.
Collective action for knowledge mobilisation: a realist evaluation of the collaborations for leadership in applied health research and care
Rycroft-Malone, J., Burton, C., Wilkinson, J., Harvey, G., McCormack, B., Baker, R., Dopson, S., Graham, I., Staniszewska, S., Thompson, C., Ariss, S., Melville-Richards, L. and Williams, L. 2015. Collective action for knowledge mobilisation: a realist evaluation of the collaborations for leadership in applied health research and care. UK NIHR Journals Library. https://doi.org/10.3310/hsdr03440
An untapped resource: patient and public involvement in implementation comment on "Knowledge mobilization in healthcare organizations": a view from the resource-based view of the firm
Burton, C. and Rycroft-Malone, J. 2015. An untapped resource: patient and public involvement in implementation comment on "Knowledge mobilization in healthcare organizations": a view from the resource-based view of the firm. International Journal of Health Policy and Management. 4 (12), pp. 845-847. https://doi.org/10.15171/ijhpm.2015.150
Investigating preferences for support with life after stroke: a discrete choice experiment
Burton, C., Fargher, E., Plumpton, C., Roberts, G.W, Owen, H. and Roberts, E. 2014. Investigating preferences for support with life after stroke: a discrete choice experiment. BMC Health Services Research. 14 (63). https://doi.org/10.1186/1472-6963-14-63
Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase.International journal of nursing studies
Thomas, L.H, French, B., Burton, C., Sutton, C., Forshaw, D., Dickinson, H., Leathley, M.J., Britt, D., Roe, B., Cheater, F.M, Booth, J., Watkins, C.L, ICONS Project Team, ICONS Patient and Public and Carer Involvement Groups 2014. Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase.International journal of nursing studies. International Journal of Nursing Studies. 51 (10), pp. 1308-1320. https://doi.org/10.1016/j.ijnurstu.2014.02.009
Improving skills and care standards in the support workforce for older people: a realist review
Rycroft-Malone, J., Burton, C., Hall, B., McCormack, B., Nutley, S., Seddon, D. and Williams, L. 2014. Improving skills and care standards in the support workforce for older people: a realist review. BMJ Open. 4 (5). https://doi.org/10.1136/bmjopen-2014-005356
Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review
Magklara, E., Burton, C. and Morrison, V. 2014. Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review. Clinical Rehabilitation. 28 (9). https://doi.org/10.1177/0269215514527843
Towards a programme theory for fidelity in the evaluation of complex interventions.
Masterson-Algar, P., Burton, C., Rycroft-Malone, J., Sackley, C.M. and Walker, M.F. 2014. Towards a programme theory for fidelity in the evaluation of complex interventions. Journal of Evaluation in Clinical Practice . 20 (4), pp. 445 - 452. https://doi.org/10.1111/jep.12174
Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm.
Burton, C., Rycroft Malone, J., Robert, G., Willson, A. and Hopkins, A. 2014. Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm. BMJ Open. 4:e005650. https://doi.org/10.1136/bmjopen-2014-005650
Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement.
Burton, C. and Rycroft-Malone, J. 2014. Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement. International Journal of Health Policy and Management. 3 (3), pp. 113 - 115. https://doi.org/10.15171/ijhpm.2014.74
The study protocol of: 'Initiating end of life care in stroke: clinical decision-making around prognosis'.
Burton, C., Payne, S., Turner, M., Bucknall, T., Rycroft-Malone, J., Tyrell, P., Horne, M., Ntambwe, L.I., Tyson, S., Mitchell, H., Williams, S. and Elghenzai, S. 2014. The study protocol of: 'Initiating end of life care in stroke: clinical decision-making around prognosis'. BMC Palliative Care. 13 (55). https://doi.org/10.1186/1472-684X-13-55
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.
Thomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C., Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., The ICONS Project Team and The ICONS Patient, Public and Carer Involvement Groups 2014. Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial. Trials. 15 (509). https://doi.org/10.1186/1745-6215-15-509
What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services
Burton, C.R., Horne, M., Woodward-Nutt, K., Bowen, A. and Tyrrell, P. 2014. What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services. Disability and Rehabilitation. 37 (21), pp. 1955-1960. https://doi.org/10.3109/09638288.2014.991454