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Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of…

Overview of attention for article published in Trials, July 2018
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  • Good Attention Score compared to outputs of the same age (66th percentile)

Mentioned by

twitter
7 tweeters

Citations

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1 Dimensions

Readers on

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86 Mendeley
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Title
Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)
Published in
Trials, July 2018
DOI 10.1186/s13063-018-2801-6
Pubmed ID
Authors

Nefyn H. Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A. Hughes, Eifiona Wood, Nadine E. Foster, David Walsh, Dawn Carnes, Valerie Sparkes, Elaine M. Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson

Abstract

Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

Twitter Demographics

The data shown below were collected from the profiles of 7 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 86 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 86 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 16 19%
Researcher 9 10%
Student > Master 8 9%
Student > Ph. D. Student 4 5%
Professor 4 5%
Other 16 19%
Unknown 29 34%
Readers by discipline Count As %
Nursing and Health Professions 19 22%
Medicine and Dentistry 14 16%
Pharmacology, Toxicology and Pharmaceutical Science 6 7%
Computer Science 2 2%
Business, Management and Accounting 2 2%
Other 8 9%
Unknown 35 41%

Attention Score in Context

This research output has an Altmetric Attention Score of 5. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 01 December 2018.
All research outputs
#4,501,909
of 16,557,200 outputs
Outputs from Trials
#1,748
of 4,390 outputs
Outputs of similar age
#94,032
of 281,864 outputs
Outputs of similar age from Trials
#1
of 1 outputs
Altmetric has tracked 16,557,200 research outputs across all sources so far. This one has received more attention than most of these and is in the 72nd percentile.
So far Altmetric has tracked 4,390 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 7.8. This one has gotten more attention than average, scoring higher than 59% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 281,864 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 66% of its contemporaries.
We're also able to compare this research output to 1 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them