Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/28216
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dc.contributor.authorMcClurg, Doreenen_UK
dc.contributor.authorHarris, Fionaen_UK
dc.contributor.authorGoodman, Kirsteenen_UK
dc.contributor.authorDoran, Selinaen_UK
dc.contributor.authorHagen, Suzanneen_UK
dc.contributor.authorTreweek, Shaunen_UK
dc.contributor.authorNorton, Christineen_UK
dc.contributor.authorCoggrave, Maureenen_UK
dc.contributor.authorNorrie, Johnen_UK
dc.contributor.authorRauchhaus, Petraen_UK
dc.contributor.authorDonnan, Peteren_UK
dc.contributor.authorEmmanuel, Antonen_UK
dc.contributor.authorManoukian, Sarkisen_UK
dc.contributor.authorMason, Helenen_UK
dc.date.accessioned2018-11-14T01:04:04Z-
dc.date.available2018-11-14T01:04:04Z-
dc.date.issued2018-10-31en_UK
dc.identifier.urihttp://hdl.handle.net/1893/28216-
dc.description.abstractBackground Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation. Objectives To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments. Design A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. Setting The trial took place in 12 UK hospitals. Participants PwMS who had ‘bothersome’ NBD. Intervention Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse. Main outcome measures The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Results A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, n = 99; intervention group, n = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% (n = 154) were female and 11% (n = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score –1.64, 95% confidence interval (CI) –3.32 to 0.04; p = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; p = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; p = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost–utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of –0.002 quality-adjusted life-years (QALYs) (95% CI –0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI –£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. Conclusion The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients. Future work Research is required to establish possible mechanisms of action and modes of massage delivery.en_UK
dc.language.isoenen_UK
dc.publisherNIHR Health Technology Assessment Programmeen_UK
dc.relationMcClurg D, Harris F, Goodman K, Doran S, Hagen S, Treweek S, Norton C, Coggrave M, Norrie J, Rauchhaus P, Donnan P, Emmanuel A, Manoukian S & Mason H (2018) Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. Health Technology Assessment, 22 (58), pp. 1-134. https://doi.org/10.3310/hta22580en_UK
dc.rightsPermission to reproduce material from this published report is covered by the UK government’s non-commercial licence for public sector information: http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/en_UK
dc.rights.urihttp://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/en_UK
dc.titleAbdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCTen_UK
dc.typeJournal Articleen_UK
dc.identifier.doi10.3310/hta22580en_UK
dc.identifier.pmid30375324en_UK
dc.citation.jtitleHealth Technology Assessmenten_UK
dc.citation.issn2046-4924en_UK
dc.citation.issn1366-5278en_UK
dc.citation.volume22en_UK
dc.citation.issue58en_UK
dc.citation.spage1en_UK
dc.citation.epage134en_UK
dc.citation.publicationstatusPublisheden_UK
dc.citation.peerreviewedRefereeden_UK
dc.type.statusVoR - Version of Recorden_UK
dc.contributor.funderNational Institute for Health Researchen_UK
dc.citation.date31/10/2018en_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationNMAHPen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationUniversity of Aberdeenen_UK
dc.contributor.affiliationKing's College Londonen_UK
dc.contributor.affiliationKing's College Londonen_UK
dc.contributor.affiliationUniversity of Edinburghen_UK
dc.contributor.affiliationUniversity of Dundeeen_UK
dc.contributor.affiliationUniversity of Dundeeen_UK
dc.contributor.affiliationUniversity College Londonen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.identifier.isiWOS:000448695400001en_UK
dc.identifier.scopusid2-s2.0-85055617224en_UK
dc.identifier.wtid1051950en_UK
dc.contributor.orcid0000-0003-3258-5624en_UK
dc.date.accepted2018-03-31en_UK
dcterms.dateAccepted2018-03-31en_UK
dc.date.filedepositdate2018-11-13en_UK
dc.relation.funderprojectAbdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBERen_UK
dc.relation.funderrefsee Collaboration Agreement attacheden_UK
rioxxterms.apcnot chargeden_UK
rioxxterms.typeJournal Article/Reviewen_UK
rioxxterms.versionVoRen_UK
local.rioxx.authorMcClurg, Doreen|en_UK
local.rioxx.authorHarris, Fiona|0000-0003-3258-5624en_UK
local.rioxx.authorGoodman, Kirsteen|en_UK
local.rioxx.authorDoran, Selina|en_UK
local.rioxx.authorHagen, Suzanne|en_UK
local.rioxx.authorTreweek, Shaun|en_UK
local.rioxx.authorNorton, Christine|en_UK
local.rioxx.authorCoggrave, Maureen|en_UK
local.rioxx.authorNorrie, John|en_UK
local.rioxx.authorRauchhaus, Petra|en_UK
local.rioxx.authorDonnan, Peter|en_UK
local.rioxx.authorEmmanuel, Anton|en_UK
local.rioxx.authorManoukian, Sarkis|en_UK
local.rioxx.authorMason, Helen|en_UK
local.rioxx.projectsee Collaboration Agreement attached|National Institute for Health Research|http://dx.doi.org/10.13039/501100000272en_UK
local.rioxx.freetoreaddate2018-11-13en_UK
local.rioxx.licencehttp://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/|2018-11-13|en_UK
local.rioxx.filename3021462.pdfen_UK
local.rioxx.filecount1en_UK
local.rioxx.source2046-4924en_UK
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