Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus.

Complex interventions Consensus Consensus development Exercise Foot health advice Insoles Nominal group technique Orthoses Orthotic devices Pes planus

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
11 Apr 2022
Historique:
received: 09 08 2021
accepted: 28 03 2022
entrez: 12 4 2022
pubmed: 13 4 2022
medline: 14 4 2022
Statut: epublish

Résumé

Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

Sections du résumé

BACKGROUND BACKGROUND
Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions.
METHODS METHODS
We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice.
RESULTS RESULTS
In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice.
CONCLUSIONS CONCLUSIONS
Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

Identifiants

pubmed: 35410282
doi: 10.1186/s13063-022-06251-7
pii: 10.1186/s13063-022-06251-7
pmc: PMC8996675
doi:

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

286

Subventions

Organisme : health technology assessment programme
ID : NIHR 127510

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© 2022. The Author(s).

Références

Gijon-Nogueron G, Martinez-Nova A, Alfageme-Garcia P, Montes-Alguacil J, Evans AM. International normative data for paediatric foot posture assessment: a cross-sectional investigation. BMJ Open. 2019;9(4):e023341. https://doi.org/10.1136/bmjopen-2018-023341 .
doi: 10.1136/bmjopen-2018-023341 pubmed: 30987983 pmcid: 6500282
Volpon JB. Footprint analysis during the growth period. J Pediatr Orthop. 1994;14(1):83–5. https://doi.org/10.1097/01241398-199401000-00017 .
doi: 10.1097/01241398-199401000-00017 pubmed: 8113378
Martinez-Nova A, et al. Foot posture development in children aged 5 to11 years: A three-year prospective study. Gait Posture. 2018;62:280–4. https://doi.org/10.1016/j.gaitpost.2018.03.032 .
doi: 10.1016/j.gaitpost.2018.03.032 pubmed: 29604617
Morrison SC, McClymont J, Price C, Nester C. Time to revise our dialogue: how flat is the paediatric flatfoot? J Foot Ankle Res. 2017;10(1):50. https://doi.org/10.1186/s13047-017-0233-2 .
doi: 10.1186/s13047-017-0233-2 pubmed: 29201146 pmcid: 5697058
Kothari A, Stebbins J, Zavatsky AB, Theologis T. Health-related quality of life in children with flexible flatfeet: a cross-sectional study. J Child Orthop. 2014;8(6):489–96. https://doi.org/10.1007/s11832-014-0621-0 .
doi: 10.1007/s11832-014-0621-0 pubmed: 25376653 pmcid: 4252274
Roth-Isigkeit A, Thyen U, Stöven H, Schwarzenberger J, Schmucker P. Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics. 2005;115(2):e152–62. https://doi.org/10.1542/peds.2004-0682 .
doi: 10.1542/peds.2004-0682 pubmed: 15687423
Wrotniak BH, Epstein LH, Dorn JM, Jones KE, Kondilis VA. The relationship between motor proficiency and physical activity in children. Pediatrics. 2006;118(6):e1758–65. https://doi.org/10.1542/peds.2006-0742 .
doi: 10.1542/peds.2006-0742 pubmed: 17142498
Morrison SC, Tait M, Bong E, Kane KJ, Nester C. Symptomatic pes planus in children: a synthesis of allied health professional practices. J Foot Ankle Res. 2020;13(1):5. https://doi.org/10.1186/s13047-020-0372-8 .
doi: 10.1186/s13047-020-0372-8 pubmed: 31998410 pmcid: 6979376
Dars S, Uden H, Kumar S, Banwell HA. When, why and how foot orthoses (FOs) should be prescribed for children with flexible pes planus: a Delphi survey of podiatrists. PeerJ. 2018;6:e4667. https://doi.org/10.7717/peerj.4667 .
doi: 10.7717/peerj.4667 pubmed: 29682429 pmcid: 5907774
Evans AM. The flat-footed child -- to treat or not to treat: what is the clinician to do? J Am Podiatr Med Assoc. 2008;98(5):386–93. https://doi.org/10.7547/0980386 .
doi: 10.7547/0980386 pubmed: 18820042
Harris EJ, Vanore JV, Thomas JL, Kravitz SR, Mendelson SA, Mendicino RW, et al. Diagnosis and treatment of pediatric flatfoot. J Foot Ankle Surg. 2004;43(6):341–73. https://doi.org/10.1053/j.jfas.2004.09.013 .
doi: 10.1053/j.jfas.2004.09.013 pubmed: 15605048
Dars S, Uden H, Banwell HA, Kumar S. The effectiveness of non-surgical intervention (Foot Orthoses) for paediatric flexible pes planus: A systematic review: Update. PLoS One. 2018;13(2):e0193060. https://doi.org/10.1371/journal.pone.0193060 .
doi: 10.1371/journal.pone.0193060 pubmed: 29451921 pmcid: 5815602
Rome K, Ashford RL, Evans A. Non-surgical interventions for paediatric pes planus. Cochrane Database Syst Rev. 2010;7:CD006311. https://doi.org/10.1002/14651858.CD006311.pub2 .
doi: 10.1002/14651858.CD006311.pub2
Jane MacKenzie A, Rome K, Evans AM. The efficacy of nonsurgical interventions for pediatric flexible flat foot: a critical review. J Pediatr Orthop. 2012;32(8):830–4. https://doi.org/10.1097/BPO.0b013e3182648c95 .
doi: 10.1097/BPO.0b013e3182648c95 pubmed: 23147627
Evans AM, et al. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022;1(1). https://doi.org/10.1002/14651858.CD006311.pub4 .
Datta J, Petticrew M. Challenges to evaluating complex interventions: a content analysis of published papers. BMC Public Health. 2013;13(1):568. https://doi.org/10.1186/1471-2458-13-568 .
doi: 10.1186/1471-2458-13-568 pubmed: 23758638 pmcid: 3699389
Hawe P, Shiell A, Riley T. Complex interventions: how "out of control" can a randomised controlled trial be? BMJ. 2004;328(7455):1561–3. https://doi.org/10.1136/bmj.328.7455.1561 .
doi: 10.1136/bmj.328.7455.1561 pubmed: 15217878 pmcid: 437159
Schroer S, Adamson J. Acupuncture for depression: a critique of the evidence base. CNS Neurosci Ther. 2011;17(5):398–410. https://doi.org/10.1111/j.1755-5949.2010.00159.x .
doi: 10.1111/j.1755-5949.2010.00159.x pubmed: 21091639
Council, M.R, A framework for development and evaluation of RCTs for complex interventions to improve health. 2000.
Ashby RL, Gabe R, Ali S, Adderley U, Bland JM, Cullum NA, et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet. 2014;383(9920):871–9. https://doi.org/10.1016/S0140-6736(13)62368-5 .
doi: 10.1016/S0140-6736(13)62368-5 pubmed: 24315520
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350(mar19 6):h1258. https://doi.org/10.1136/bmj.h1258 .
doi: 10.1136/bmj.h1258 pubmed: 25791983 pmcid: 4366184
Mills T, Lawton R, Sheard L. Advancing complexity science in healthcare research: the logic of logic models. BMC Med Res Methodol. 2019;19(1):55. https://doi.org/10.1186/s12874-019-0701-4 .
doi: 10.1186/s12874-019-0701-4 pubmed: 30871474 pmcid: 6419426
Sondergaard E, et al. Using a modified nominal group technique to develop general practice. BMC Fam Pract. 2018;19(1):117. https://doi.org/10.1186/s12875-018-0811-9 .
doi: 10.1186/s12875-018-0811-9 pubmed: 30021508 pmcid: 6052560
Gallagher M, et al. The nominal group technique: a research tool for general practice? Fam Pract. 1993;10(1):76–81. https://doi.org/10.1093/fampra/10.1.76 .
doi: 10.1093/fampra/10.1.76 pubmed: 8477899
Chapman LS, Redmond AC, Landorf KB, Rome K, Keenan AM, Waxman R, et al. Foot orthoses for people with rheumatoid arthritis: a survey of prescription habits among podiatrists. J Foot Ankle Res. 2019;12(1):7. https://doi.org/10.1186/s13047-019-0314-5 .
doi: 10.1186/s13047-019-0314-5 pubmed: 30700994 pmcid: 6347791
Chapman LS, Redmond AC, Landorf KB, Rome K, Keenan AM, Waxman R, et al. A survey of foot orthoses prescription habits amongst podiatrists in the UK, Australia and New Zealand. J Foot Ankle Res. 2018;11(1):64. https://doi.org/10.1186/s13047-018-0304-z .
doi: 10.1186/s13047-018-0304-z pubmed: 30505351 pmcid: 6258496
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. https://doi.org/10.1136/bmj.a1655 .
doi: 10.1136/bmj.a1655 pubmed: 18824488 pmcid: 2769032
Fletcher A, Jamal F, Moore G, Evans RE, Murphy S, Bonell C. Realist complex intervention science: Applying realist principles across all phases of the Medical Research Council framework for developing and evaluating complex interventions. Evaluation (Lond). 2016;22(3):286–303. https://doi.org/10.1177/1356389016652743 .
doi: 10.1177/1356389016652743
Baxter R, Murray J, O’Hara JK, Hewitt C, Richardson G, Cockayne S, et al. Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial. Pilot Feasibility Stud. 2020;6(1):123. https://doi.org/10.1186/s40814-020-00655-5 .
doi: 10.1186/s40814-020-00655-5 pubmed: 32905158 pmcid: 7466784

Auteurs

Michael R Backhouse (MR)

Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.

Daniel J Parker (DJ)

School of Health and Society, University of Salford, Salford, UK.

Stewart C Morison (SC)

School of Life Course & Population Sciences, Kings College London, London, UK.

Jenny Anderson (J)

School of Health and Society, University of Salford, Salford, UK.

Sarah Cockayne (S)

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Joy A Adamson (JA)

York Trials Unit, Department of Health Sciences, University of York, York, UK. joy.admason@york.ac.uk.

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