lancet-header
Preprints with The Lancet is part of SSRN´s First Look, a place where journals and other research experts identify content of interest prior to publication. These preprint papers are not peer-reviewed and are posted here as part of a 12-month trial. Authors have either opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet, or submitted directly via SSRN. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. These papers should not be used for clinical decision making or reporting of research to a lay audience without indicating that this is preliminary research that has not been peer-reviewed. For more information see the Comment published in The Lancet, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com

Nurse-Led versus Usual (General Practitioner-Led) Care of People with Gout: A UK Community-Based, Two Year, Randomised Controlled Trial

31 Pages Posted: 14 Sep 2018

See all articles by Michael Doherty

Michael Doherty

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Wendy Jenkins

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Helen Richardson

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Aliya Sarmanova

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Abhishek Abhishek

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Deborah Ashton

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Christine Barclay

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Sally Doherty

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Lelia Duley

University of Nottingham - Nottingham Clinical Trials Unit

Rachael Hatton

University of Sheffield - Health Economics and Decision Science Research Group (HEDS)

Frances Rees

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Matthew Stevenson

University of Sheffield - Health Economics and Decision Science Research Group (HEDS)

Weiya Zhang

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

More...

Abstract

Background: In the UK gout management is suboptimal, only 40% of patients receiving urate-lowering therapy (ULT), usually without titration to a target serum urate (SU) level. Nurses successfully manage many diseases in primary care. This trial compared nurse-led care to ongoing usual (general practitioner-led) care for people with gout.

Methods: Research nurses were trained in best practice management of gout, including full individualised patient information and engagement in shared decision-making. Adults with acute gout in the previous year were randomised (1:1) to nurse-led or continuing usual care in the community. Assessments were at baseline, one and two years. The primary outcome was percentage of participants achieving SUA<360μmol/L at two years. Secondary outcomes were attack frequency in year two, presence of tophi, quality of life (SF-36) and cost per quality-adjusted life year (QALY) gained. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated based on intention to treat with multiple imputation.

Findings: Of 517 participants, 255 were assigned nurse-led care and 262 usual care. Comparing nurse-led to usual care groups at two years: 96% versus 56% were on ULT with 79% versus 10% taking allopurinol >300mg/day (all p<0•001); 95% versus 30% had SU<360μmol/L (RR 3•18, 95%CI 2•42 to 4•18); 3% versus 11% had tophi (RR 0•09, 0•02-0•36); and mean (SD) SF-36 physical component scores were 41•31(16•76) versus 37•87(14•31) (p<0•05). During year two, 8% versus 24% had >2 gout attacks respectively (RR 0•33, 0•19-0•57). The cost per QALY gained for the nurse-led intervention was £5066 at two years, and modelled to be £286 at three years and cost-saving at five years.

Interpretation: Nurse-led gout care is clinically effective and also cost-effective compared to usual care. These findings illustrate the benefits of patient education and engagement in gout management, and reaffirm the importance of a treat-to-target ULT strategy to improve patient-centred outcomes.

Trial Registration Number: National Clinical Trials Registry (www.clinicaltrials.gov ref: NCT01477346).

Funding: Arthritis Research UK fully funded the study (Award 19703).

Declaration of Interest: MD and AA have received research funding from AstraZeneca for a PI-led “sons of gout” study; MD has received consultation fees from AstraZeneca, Grunenthal and Mallinckrodt; WZ has received consultation fees from AstraZeneca and Grunenthal. Other authors have no conflict of interest.

Ethical Approval: It was approved by East Midlands Nottingham Research Ethics Committee (12/EM/0044) and registered with the National Clinical Trials Registry.

Suggested Citation

Doherty, Michael and Jenkins, Wendy and Richardson, Helen and Sarmanova, Aliya and Abhishek, Abhishek and Ashton, Deborah and Barclay, Christine and Doherty, Sally and Duley, Lelia and Hatton, Rachael and Rees, Frances and Stevenson, Matthew and Zhang, Weiya, Nurse-Led versus Usual (General Practitioner-Led) Care of People with Gout: A UK Community-Based, Two Year, Randomised Controlled Trial (July 26, 2018). Available at SSRN: https://ssrn.com/abstract=3221414

Michael Doherty (Contact Author)

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology ( email )

Nottingham
United Kingdom

Wendy Jenkins

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Helen Richardson

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Aliya Sarmanova

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Abhishek Abhishek

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Deborah Ashton

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Christine Barclay

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Sally Doherty

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Lelia Duley

University of Nottingham - Nottingham Clinical Trials Unit

Nottingham
United Kingdom

Rachael Hatton

University of Sheffield - Health Economics and Decision Science Research Group (HEDS)

Sheffield, S10 2TN
United Kingdom

Frances Rees

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Matthew Stevenson

University of Sheffield - Health Economics and Decision Science Research Group (HEDS)

Sheffield, S10 2TN
United Kingdom

Weiya Zhang

University of Nottingham - Division of Rheumatology, Orthopaedics and Dermatology

Nottingham
United Kingdom

Click here to go to TheLancet.com

Go to TheLancet.com

Paper statistics

Abstract Views
79
Downloads
23