Evidence map›Paper›PMID 29467019›Full record

ArticleTrials2018

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

Vikki Wylde, Wendy Bertram, Andrew D Beswick, Ashley W Blom, Julie Bruce, Amanda Burston, Jane Dennis, Kirsty Garfield, Nicholas Howells, Athene Lane and 10 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 1 country.

Vikki WyldeMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK. v.wylde@bristol.ac.uk.ORCID http://orcid.org/0000-0002-8460-1529
Wendy BertramMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Andrew D BeswickMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Ashley W BlomMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Julie BruceWarwick Clinical Trials Unit, University of Warwick, Warwick, UK.
Amanda BurstonMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Jane DennisMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Kirsty GarfieldBristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Nicholas HowellsNorth Bristol NHS Trust, Bristol, UK.
Athene LaneBristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Candy McCabeDepartment of Nursing and Midwifery, Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
Andrew J MooreMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Sian NobleBristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Tim J PetersMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Andrew PriceNuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Science, University of Oxford, Oxford, UK.
Emily SandersonBristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Andrew D TomsExeter Knee Reconstruction Unit, Royal Devon and Exeter Hospital, Exeter, UK.
David A WalshArthritis Research UK Pain Centre and NIHR Nottingham BRC, University of Nottingham, Nottingham, UK.
Simon WhiteCardiff & Vale Orthopaedic Centre, University Hospital Llandough, Penarth, UK.
Rachael Gooberman-HillMusculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
Southmead Hospital · GBUniversity of Bristol · GBNorth Bristol NHS Trust · GBUniversity Hospitals Bristol NHS Foundation Trust · GBNuffield Orthopaedic Centre · GBRoyal Devon and Exeter Hospital · GBUniversity Hospital Llandough · GBUniversity of Nottingham · GBUniversity of the West of England · GBUniversity of Warwick · GB

Funding

Department of Health RP-PG-0613-20001Medical Research Council G106/1178Medical Research Council MR/K025643/1Programme Grants for Applied Research RP-PG-0613-20001
6 · The paper itself

Abstract

backgroundApproximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care.

methodsThis is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. DISCUSSION: If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement.

trial registrationISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.

Indexed as

Critical PathwaysPain ManagementArthroplasty, Replacement, KneeChronic PainCost-Benefit AnalysisHealth Care CostsHumansMulticenter Studies as TopicPain MeasurementPilot ProjectsPostoperative PainPragmatic Clinical Trials as TopicSecondary Health CareTime FactorsTreatment OutcomeUnited KingdomCare pathwayChronic post-surgical painRandomised controlled trialTotal knee replacement

Identifiers

PMID29467019
PMCPMC5822621
OpenAlexW2788640127

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.