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Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.

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Title: Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.
Authors: Mallucci, Conor L (AUTHOR), Jenkinson, Michael D (AUTHOR), Conroy, Elizabeth J (AUTHOR), Hartley, John C (AUTHOR), Brown, Michaela (AUTHOR), Dalton, Joanne (AUTHOR), Kearns, Tom (AUTHOR), Moitt, Tracy (AUTHOR), Griffiths, Michael J (AUTHOR), Culeddu, Giovanna (AUTHOR), Solomon, Tom (AUTHOR), Hughes, Dyfrig (AUTHOR), Gamble, Carrol (AUTHOR), BASICS Study collaborators (CORPORATE AUTHOR)
Source: Lancet. 10/26/2019, Vol. 394 Issue 10208, p1530-1539. 10p.
Subjects: Antibiotics, Evaluation research, Hydrocephalus, Catheter-related infections, Blind experiment, Cost benefit analysis, Randomized controlled trials, Silver, Research methodology, Research, Comparative studies, Drug-eluting stents, Cerebrospinal fluid shunts
Abstract: Background: Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection.Methods: In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281.Findings: Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function.Interpretation: The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection.Funding: UK National Institute for Health Research Health Technology Assessment programme. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.
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  Data: <searchLink fieldCode="AR" term="%22Mallucci%2C+Conor+L%22">Mallucci, Conor L</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Jenkinson%2C+Michael+D%22">Jenkinson, Michael D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Conroy%2C+Elizabeth+J%22">Conroy, Elizabeth J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hartley%2C+John+C%22">Hartley, John C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brown%2C+Michaela%22">Brown, Michaela</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dalton%2C+Joanne%22">Dalton, Joanne</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kearns%2C+Tom%22">Kearns, Tom</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Moitt%2C+Tracy%22">Moitt, Tracy</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Griffiths%2C+Michael+J%22">Griffiths, Michael J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Culeddu%2C+Giovanna%22">Culeddu, Giovanna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Solomon%2C+Tom%22">Solomon, Tom</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hughes%2C+Dyfrig%22">Hughes, Dyfrig</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gamble%2C+Carrol%22">Gamble, Carrol</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22BASICS+Study+collaborators%22">BASICS Study collaborators</searchLink> (CORPORATE AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 10/26/2019, Vol. 394 Issue 10208, p1530-1539. 10p.
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  Data: <searchLink fieldCode="DE" term="%22Antibiotics%22">Antibiotics</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation+research%22">Evaluation research</searchLink><br /><searchLink fieldCode="DE" term="%22Hydrocephalus%22">Hydrocephalus</searchLink><br /><searchLink fieldCode="DE" term="%22Catheter-related+infections%22">Catheter-related infections</searchLink><br /><searchLink fieldCode="DE" term="%22Blind+experiment%22">Blind experiment</searchLink><br /><searchLink fieldCode="DE" term="%22Cost+benefit+analysis%22">Cost benefit analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Silver%22">Silver</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Research%22">Research</searchLink><br /><searchLink fieldCode="DE" term="%22Comparative+studies%22">Comparative studies</searchLink><br /><searchLink fieldCode="DE" term="%22Drug-eluting+stents%22">Drug-eluting stents</searchLink><br /><searchLink fieldCode="DE" term="%22Cerebrospinal+fluid+shunts%22">Cerebrospinal fluid shunts</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: <bold>Background: </bold>Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection.<bold>Methods: </bold>In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281.<bold>Findings: </bold>Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function.<bold>Interpretation: </bold>The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection.<bold>Funding: </bold>UK National Institute for Health Research Health Technology Assessment programme. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1016/S0140-6736(19)31603-4
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      – Code: eng
        Text: English
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        StartPage: 1530
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      – SubjectFull: Antibiotics
        Type: general
      – SubjectFull: Evaluation research
        Type: general
      – SubjectFull: Hydrocephalus
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      – SubjectFull: Catheter-related infections
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      – SubjectFull: Blind experiment
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      – SubjectFull: Cost benefit analysis
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      – SubjectFull: Randomized controlled trials
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      – SubjectFull: Silver
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      – SubjectFull: Drug-eluting stents
        Type: general
      – SubjectFull: Cerebrospinal fluid shunts
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              Text: 10/26/2019
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