Publications by authors named "Girvan Burnside"

54 Publications

Surgical microdiscectomy versus transforaminal epidural steroid injection in patients with sciatica secondary to herniated lumbar disc (NERVES): a phase 3, multicentre, open-label, randomised controlled trial and economic evaluation.

Lancet Rheumatol 2021 May 18;3(5):e347-e356. Epub 2021 Mar 18.

Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.

Background: The optimal invasive treatment for sciatica secondary to herniated lumbar disc remains controversial, with a paucity of evidence for use of non-surgical treatments such as transforaminal epidural steroid injection (TFESI) over surgical microdiscectomy. We aimed to investigate the clinical and cost-effectiveness of these options for management of radicular pain secondary to herniated lumbar disc.

Methods: We did a pragmatic, multicentre, phase 3, open-label, randomised controlled trial at 11 spinal units across the UK. Eligible patients were aged 16-65 years, had MRI-confirmed non-emergency sciatica secondary to herniated lumbar disc with symptom duration between 6 weeks and 12 months, and had leg pain that was not responsive to non-invasive management. Participants were randomly assigned (1:1) to receive either TFESI or surgical microdiscectomy by an online randomisation system that was stratified by centre with random permuted blocks. The primary outcome was Oswestry Disability Questionnaire (ODQ) score at 18 weeks. All randomly assigned participants who completed a valid ODQ at baseline and at 18 weeks were included in the analysis. Safety analysis included all treated participants. Cost-effectiveness was estimated from the EuroQol-5D-5L, Hospital Episode Statistics, medication usage, and self-reported resource-use data. This trial was registered with ISRCTN, number ISRCTN04820368, and EudraCT, number 2014-002751-25.

Findings: Between March 6, 2015, and Dec 21, 2017, 163 (15%) of 1055 screened patients were enrolled, with 80 participants (49%) randomly assigned to the TFESI group and 83 participants (51%) to the surgery group. At week 18, ODQ scores were 30·02 (SD 24·38) for 63 assessed patients in the TFESI group and 22·30 (19·83) for 61 assessed patients in the surgery group. Mean improvement was 24·52 points (18·89) for the TFESI group and 26·74 points (21·35) for the surgery group, with an estimated treatment difference of -4·25 (95% CI -11·09 to 2·59; p=0·22). There were four serious adverse events in four participants associated with surgery, and none with TFESI. Compared with TFESI, surgery had an incremental cost-effectiveness ratio of £38 737 per quality-adjusted life-year gained, and a 0·17 probability of being cost-effective at a willingness-to-pay threshold of £20 000 per quality-adjusted life-year.

Interpretation: For patients with sciatica secondary to herniated lumbar disc, with symptom duration of up to 12 months, TFESI should be considered as a first invasive treatment option. Surgery is unlikely to be a cost-effective alternative to TFESI.

Funding: Health Technology Assessment programme of the National Institute for Health Research (NIHR), UK.
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http://dx.doi.org/10.1016/S2665-9913(21)00036-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080892PMC
May 2021

Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT.

Health Technol Assess 2021 Apr;25(24):1-86

Liverpool Clinical Trials Centre, University of Liverpool (member of Liverpool Health Partners), Liverpool, UK.

Background: Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment.

Objective: To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months' duration.

Interventions: Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection.

Design: A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration.

Setting: NHS services providing secondary spinal surgical care within the UK.

Participants: A total of 163 participants (aged 16-65 years) were recruited from 11 UK NHS outpatient clinics.

Main Outcome Measures: The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland-Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England.

Results: Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland-Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year.

Limitations: Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment.

Conclusions: To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc.

Future Work: These results will lead to further studies in the streamlining and earlier management of discogenic sciatica.

Trial Registration: Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 24. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8072519PMC
April 2021

The SANAD II study of the effectiveness and cost-effectiveness of valproate versus levetiracetam for newly diagnosed generalised and unclassifiable epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial.

Lancet 2021 04;397(10282):1375-1386

The Alan Richens Epilepsy Unit, University Hospital of Wales, Cardiff, Wales, UK.

Background: Valproate is a first-line treatment for patients with newly diagnosed idiopathic generalised or difficult to classify epilepsy, but not for women of child-bearing potential because of teratogenicity. Levetiracetam is increasingly prescribed for these patient populations despite scarcity of evidence of clinical effectiveness or cost-effectiveness. We aimed to compare the long-term clinical effectiveness and cost-effectiveness of levetiracetam compared with valproate in participants with newly diagnosed generalised or unclassifiable epilepsy.

Methods: We did an open-label, randomised controlled trial to compare levetiracetam with valproate as first-line treatment for patients with generalised or unclassified epilepsy. Adult and paediatric neurology services (69 centres overall) across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked generalised or unclassifiable seizures. Participants were randomly allocated (1:1) to receive either levetiracetam or valproate, using a minimisation programme with a random element utilising factors. Participants and investigators were aware of treatment allocation. For participants aged 12 years or older, the initial advised maintenance doses were 500 mg twice per day for levetiracetam and valproate, and for children aged 5-12 years, the initial daily maintenance doses advised were 25 mg/kg for valproate and 40 mg/kg for levetiracetam. All drugs were administered orally. SANAD II was designed to assess the non-inferiority of levetiracetam compared with valproate for the primary outcome time to 12-month remission. The non-inferiority limit was a hazard ratio (HR) of 1·314, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on valproate. All participants were included in the intention-to-treat (ITT) analysis. Per-protocol (PP) analyses excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analyses included all participants who received one dose of any study drug. This trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64).

Findings: 520 participants were recruited between April 30, 2013, and Aug 2, 2016, and followed up for a further 2 years. 260 participants were randomly allocated to receive levetiracetam and 260 participants to receive valproate. The ITT analysis included all participants and the PP analysis included 255 participants randomly allocated to valproate and 254 randomly allocated to levetiracetam. Median age of participants was 13·9 years (range 5·0-94·4), 65% were male and 35% were female, 397 participants had generalised epilepsy, and 123 unclassified epilepsy. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission (HR 1·19 [95% CI 0·96-1·47]); non-inferiority margin 1·314. The PP analysis showed that the 12-month remission was superior with valproate than with levetiracetam. There were two deaths, one in each group, that were unrelated to trial treatments. Adverse reactions were reported by 96 (37%) participants randomly assigned to valproate and 107 (42%) participants randomly assigned to levetiracetam. Levetiracetam was dominated by valproate in the cost-utility analysis, with a negative incremental net health benefit of -0·040 (95% central range -0·175 to 0·037) and a probability of 0·17 of being cost-effectiveness at a threshold of £20 000 per quality-adjusted life-year. Cost-effectiveness was based on differences between treatment groups in costs and quality-adjusted life-years.

Interpretation: Compared with valproate, levetiracetam was found to be neither clinically effective nor cost-effective. For girls and women of child-bearing potential, these results inform discussions about benefit and harm of avoiding valproate.

Funding: National Institute for Health Research Health Technology Assessment Programme.
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http://dx.doi.org/10.1016/S0140-6736(21)00246-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047813PMC
April 2021

The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial.

Lancet 2021 Apr;397(10282):1363-1374

The Alan Richens Epilepsy Unit, University Hospital of Wales, Cardiff, Wales, UK.

Background: Levetiracetam and zonisamide are licensed as monotherapy for patients with focal epilepsy, but there is uncertainty as to whether they should be recommended as first-line treatments because of insufficient evidence of clinical effectiveness and cost-effectiveness. We aimed to assess the long-term clinical effectiveness and cost-effectiveness of levetiracetam and zonisamide compared with lamotrigine in people with newly diagnosed focal epilepsy.

Methods: This randomised, open-label, controlled trial compared levetiracetam and zonisamide with lamotrigine as first-line treatment for patients with newly diagnosed focal epilepsy. Adult and paediatric neurology services across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked focal seizures. Participants were randomly allocated (1:1:1) using a minimisation programme with a random element utilising factor to receive lamotrigine, levetiracetam, or zonisamide. Participants and investigators were not masked and were aware of treatment allocation. SANAD II was designed to assess non-inferiority of both levetiracetam and zonisamide to lamotrigine for the primary outcome of time to 12-month remission. Anti-seizure medications were taken orally and for participants aged 12 years or older the initial advised maintenance doses were lamotrigine 50 mg (morning) and 100 mg (evening), levetiracetam 500 mg twice per day, and zonisamide 100 mg twice per day. For children aged between 5 and 12 years the initial daily maintenance doses advised were lamotrigine 1·5 mg/kg twice per day, levetiracetam 20 mg/kg twice per day, and zonisamide 2·5 mg/kg twice per day. All participants were included in the intention-to-treat (ITT) analysis. The per-protocol (PP) analysis excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analysis included all participants who received one dose of any study drug. The non-inferiority limit was a hazard ratio (HR) of 1·329, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on lamotrigine. The trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64).

Findings: 990 participants were recruited between May 2, 2013, and June 20, 2017, and followed up for a further 2 years. Patients were randomly assigned to receive lamotrigine (n=330), levetiracetam (n=332), or zonisamide (n=328). The ITT analysis included all participants and the PP analysis included 324 participants randomly assigned to lamotrigine, 320 participants randomly assigned to levetiracetam, and 315 participants randomly assigned to zonisamide. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission versus lamotrigine (HR 1·18; 97·5% CI 0·95-1·47) but zonisamide did meet the criteria for non-inferiority in the ITT analysis versus lamotrigine (1·03; 0·83-1·28). The PP analysis showed that 12-month remission was superior with lamotrigine than both levetiracetam (HR 1·32 [97·5% CI 1·05 to 1·66]) and zonisamide (HR 1·37 [1·08-1·73]). There were 37 deaths during the trial. Adverse reactions were reported by 108 (33%) participants who started lamotrigine, 144 (44%) participants who started levetiracetam, and 146 (45%) participants who started zonisamide. Lamotrigine was superior in the cost-utility analysis, with a higher net health benefit of 1·403 QALYs (97·5% central range 1·319-1·458) compared with 1·222 (1·110-1·283) for levetiracetam and 1·232 (1·112, 1·307) for zonisamide at a cost-effectiveness threshold of £20 000 per QALY. Cost-effectiveness was based on differences between treatment groups in costs and QALYs.

Interpretation: These findings do not support the use of levetiracetam or zonisamide as first-line treatments for patients with focal epilepsy. Lamotrigine should remain a first-line treatment for patients with focal epilepsy and should be the standard treatment in future trials.

Funding: National Institute for Health Research Health Technology Assessment programme.
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http://dx.doi.org/10.1016/S0140-6736(21)00247-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047799PMC
April 2021

Clinical outcomes of single implant supported crowns versus 3-unit implant-supported fixed dental prostheses in Dubai Health Authority: a retrospective study.

BMC Oral Health 2021 04 1;21(1):171. Epub 2021 Apr 1.

Hamdan Bin Mohamed College of Dental Medicine, Mohamed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai, UAE.

Background: This study assessed retrospectively the clinical outcomes of single implant-supported crowns and implant-supported fixed dental prostheses (FDPs).

Methods: This case series compared biological and technical complications in single implant-supported crowns and implant-supported bridges in a time framed sample of all patients who received dental implants between 2009 and 2016 in Dubai Health Authority. Only 3-unit implant-supported prostheses (FDPs) with one intervening pontic and an implant each end were included for comparison to single crown supported implants. Cantilevered implants, implant-supported dentures and cases involving bone grafts or sinus lifts were excluded. The primary outcome measure was marginal bone loss, measured on digital radiographs taken after prosthesis placement at baseline and one year after implant loading, whilst peri-implantitis and technical complications were secondary outcomes. Mixed regression models adjusted for clustering of implants within patients was used for patient and implant factor associations.

Results: A total of 454 patients (152 males; 302 females) had 1673 implants. The mean age of males (53.7 years, SD 14.6) was significantly greater than females (49.3 years, SD 12.9, p < 0.001). Mean mesial bone loss on the FDPs was significantly greater at 1 year (1.14 mm, SD 0.63) compared with the mesial surface of single implant-supported crowns (0.30 mm, SD 0.43, p < 0.001). Mean distal bone loss was also significantly greater at 1 year on the distal surfaces of implants supporting bridgework (1.29 mm, SD 0.71) compared with distal surfaces on single implant-supported crowns (0.36 mm, SD 0.54, p < 0.001). Mean marginal bone loss mesially and distally around implants placed in the lower anterior sextant was significantly greater compared to all other sites (p < 0.001). Bone loss by gender, patient's age and medical condition was not different between the 2 implant groups. Screw loosening was the main technical complication (11.5%) whilst peri-implantitis occurred rarely (0.5%). The 66 cement retained implants had significantly more complications compared to the 1607 screw retained implants (p < 0.001).

Conclusions: Mean marginal bone loss around the supporting implants of FDPs (3-unit fixed bridgework) was greater than on single implant-supported crowns at one year after implant loading. Position in the mouth was associated with bone loss. Biological and technical complications occurred rarely.
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http://dx.doi.org/10.1186/s12903-021-01530-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017629PMC
April 2021

Neurological disease in adults with Zika and chikungunya virus infection in Northeast Brazil: a prospective observational study.

Lancet Neurol 2020 10 16;19(10):826-839. Epub 2020 Sep 16.

National Institute for Health Research Health Protection Research Unit on Emerging and Zoonotic Infections, Institute of Infection, Veterinary & Ecological Sciences, University of Liverpool, Liverpool, UK; The Walton Centre NHS Foundation Trust, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. Electronic address:

Background: Since 2015, the arthropod-borne viruses (arboviruses) Zika and chikungunya have spread across the Americas causing outbreaks, accompanied by increases in immune-mediated and infectious neurological disease. The spectrum of neurological manifestations linked to these viruses, and the importance of dual infection, are not known fully. We aimed to investigate whether neurological presentations differed according to the infecting arbovirus, and whether patients with dual infection had a different disease spectrum or severity.

Methods: We report a prospective observational study done during epidemics of Zika and chikungunya viruses in Recife, Pernambuco, a dengue-endemic area of Brazil. We recruited adults aged 18 years or older referred to Hospital da Restauração, a secondary-level and tertiary-level hospital, with suspected acute neurological disease and a history of suspected arboviral infection. We looked for evidence of Zika, chikungunya, or dengue infection by viral RNA or specific IgM antibodies in serum or CSF. We grouped patients according to their arbovirus laboratory diagnosis and then compared demographic and clinical characteristics.

Findings: Between Dec 4, 2014, and Dec 4, 2016, 1410 patients were admitted to the hospital neurology service; 201 (14%) had symptoms consistent with arbovirus infection and sufficient samples for diagnostic testing and were included in the study. The median age was 48 years (IQR 34-60), and 106 (53%) were women. 148 (74%) of 201 patients had laboratory evidence of arboviral infection. 98 (49%) of them had a single viral infection (41 [20%] had Zika, 55 [27%] had chikungunya, and two [1%] had dengue infection), whereas 50 (25%) had evidence of dual infection, mostly with Zika and chikungunya viruses (46 [23%] patients). Patients positive for arbovirus infection presented with a broad range of CNS and peripheral nervous system (PNS) disease. Chikungunya infection was more often associated with CNS disease (26 [47%] of 55 patients with chikungunya infection vs six [15%] of 41 with Zika infection; p=0·0008), especially myelitis (12 [22%] patients). Zika infection was more often associated with PNS disease (26 [63%] of 41 patients with Zika infection vs nine [16%] of 55 with chikungunya infection; p≤0·0001), particularly Guillain-Barré syndrome (25 [61%] patients). Patients with Guillain-Barré syndrome who had Zika and chikungunya dual infection had more aggressive disease, requiring intensive care support and longer hospital stays, than those with mono-infection (median 24 days [IQR 20-30] vs 17 days [10-20]; p=0·0028). Eight (17%) of 46 patients with Zika and chikungunya dual infection had a stroke or transient ischaemic attack, compared with five (6%) of 96 patients with Zika or chikungunya mono-infection (p=0·047).

Interpretation: There is a wide and overlapping spectrum of neurological manifestations caused by Zika or chikungunya mono-infection and by dual infections. The possible increased risk of acute cerebrovascular disease in patients with dual infection merits further investigation.

Funding: Fundação do Amparo a Ciência e Tecnologia de Pernambuco (FACEPE), EU's Horizon 2020 research and innovation programme, National Institute for Health Research.

Translations: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S1474-4422(20)30232-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7494308PMC
October 2020

Study protocol for a pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of standard and new antiepileptic drugs (SANAD-II).

BMJ Open 2020 08 26;10(8):e040635. Epub 2020 Aug 26.

Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK

Introduction: Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Over the past 20 years, a number of new drugs have been approved for National Health Service (NHS) use on the basis of information from short-term trials that demonstrate efficacy. These trials do not provide information about the longer term outcomes, which inform treatment policy. This trial will assess the long-term clinical and cost-effectiveness of the newer treatment levetiracetam and zonisamide.

Methods And Analysis: This is a phase IV, multicentre, open-label, randomised, controlled clinical trial comparing new and standard treatments for patients with newly diagnosed epilepsy. Arm A of the trial randomised 990 patients with focal epilepsy to standard AED lamotrigine or new AED levetiracetam or zonisamide. Arm B randomised 520 patients with generalised epilepsy to standard AED sodium valproate or new AED levetiracetam. Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics. Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs. Patients are followed up for a minimum of 2 years. The primary outcome is time to 12-month remission from seizures. Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life. All primary analyses will be on an intention to treat basis. Separate analyses will be undertaken for each arm. Health economic analysis will be conducted from the perspective of the NHS to assess the cost-effectiveness of each AED.

Ethics And Dissemination: This trial has been approved by the North West-Liverpool East REC (Ref. 12/NW/0361). The trial team will disseminate the results through scientific meetings, peer-reviewed publications and patient and public involvement.

Trial Registration Numbers: EudraCT 2012-001884-64; ISRCTN30294119.
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http://dx.doi.org/10.1136/bmjopen-2020-040635DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7451282PMC
August 2020

Television advertisements for high-sugar foods and beverages: effect on children's snack food intake.

Br J Nutr 2021 Mar 4;125(5):591-597. Epub 2020 Aug 4.

Department of Psychology, University of Liverpool, LiverpoolL69 7ZA, UK.

Energy-dense food advertising affects children's eating behaviour. However, the impact of high-sugar food advertising specifically on the intake of sweet foods is underexplored. This study sought to determine whether children would increase their intake of sugar and total energy following high-sugar food advertising (relative to toy advertising) and whether dental health, weight status and socio-economic status (SES) would moderate any effect. In a crossover, randomised controlled trial, 101 UK children (forty male) aged 8-10 years were exposed to high-sugar food/beverage and toy advertisements embedded within a cartoon. Their subsequent intake of snack foods and beverages varying in sugar content was measured. A dental examination was performed, and height and weight measurements were taken. Home postcode provided by parents was used to assign participants to SES quintiles. Children consumed a significantly greater amount of energy (203·3 (95 % CI 56·5, 350·2) kJ (48·6 (95 % CI 13·5, 83·7) kcal); P = 0·007) and sugar (6·0 (95 % CI 1·3, 10·7) g; P = 0·012) following food advertisements compared with after toy advertisements. This was driven by increased intake of the items with most sugar (chocolate and jelly sweets). Children of healthy weight and with dental caries had the greatest intake response to food advertising exposure, but there were no differences by SES. Acute experimental food advertising exposure increases food intake in children. Specifically, high-sugar food and beverage advertising promotes the consumption of high-sugar food items. The debate around the negative health effects of food advertising on children should be widened to include dental health as well as overall dietary health and obesity.
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http://dx.doi.org/10.1017/S0007114520003116DOI Listing
March 2021

Vision Screening Assessment (VISA) tool: diagnostic accuracy validation of a novel screening tool in detecting visual impairment among stroke survivors.

BMJ Open 2020 06 11;10(6):e033639. Epub 2020 Jun 11.

Biostatistics, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.

Purpose: Screening for visual problems in stroke survivors is not standardised. Visual problems that remain undetected or poorly identified can create unmet needs for stroke survivors. We report the validation of a new Vision Impairment Screening Assessment (VISA) tool intended for use by the stroke team to improve identification of visual impairment in stroke survivors.

Methods: We conducted a prospective case cohort comparative study in four centres to validate the VISA tool against a specialist reference vision assessment. VISA is available in print or as an app (Medicines and Healthcare products Regulatory Agency regulatory approved); these were used equally for two groups. Both VISA and the comprehensive reference vision assessment measured case history, visual acuity, eye alignment, eye movements, visual field and visual inattention. The primary outcome measure was the presence or absence of visual impairment.

Results: Two hundred and twenty-one stroke survivors were screened. Specialist reference vision assessment was by experienced orthoptists. Full completion of screening and reference vision assessment was achieved for 201 stroke survivors. VISA print was completed for 101 stroke survivors; VISA app was completed for 100. Sensitivity and specificity of VISA print was 97.67% and 66.67%, respectively. Overall agreement was substantial; K=0.648. Sensitivity and specificity of VISA app was 88.31% and 86.96%, respectively. Overall agreement was substantial; K=0.690. Lowest agreement was found for screening of eye movement and near visual acuity.

Conclusions: This validation study indicates acceptability of VISA for screening of potential visual impairment in stroke survivors. Sensitivity and specificity were high indicating the accuracy of this screening tool. VISA is available in print or as an app allowing versatile uptake across multiple stroke settings.
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http://dx.doi.org/10.1136/bmjopen-2019-033639DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7295409PMC
June 2020

Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice.

Trials 2020 May 27;21(1):433. Epub 2020 May 27.

Department of Health Data Science, University of Liverpool, a member of Liverpool Health Partners, Liverpool, UK.

Background: Patient outcomes can depend on the treating centre, or health professional, delivering the intervention. A health professional's skill in delivery improves with experience, meaning that outcomes may be associated with learning. Considering differences in intervention delivery at trial design will ensure that any appropriate adjustments can be made during analysis. This work aimed to establish practice for the allowance of clustering and learning effects in the design and analysis of randomised multicentre trials.

Methods: A survey that drew upon quotes from existing guidelines, references to relevant publications and example trial scenarios was delivered. Registered UK Clinical Research Collaboration Registered Clinical Trials Units were invited to participate.

Results: Forty-four Units participated (N = 50). Clustering was managed through design by stratification, more commonly by centre than by treatment provider. Managing learning by design through defining a minimum expertise level for treatment provider was common (89%). One-third reported experience in expertise-based designs. The majority of Units had adjusted for clustering during analysis, although approaches varied. Analysis of learning was rarely performed for the main analysis (n = 1), although it was explored by other means. The insight behind the approaches used within and reasons for, or against, alternative approaches were provided.

Conclusions: Widespread awareness of challenges in designing and analysing multicentre trials is identified. Approaches used, and opinions on these, vary both across and within Units, indicating that approaches are dependent on the type of trial. Agreeing principles to guide trial design and analysis across a range of realistic clinical scenarios should be considered.
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http://dx.doi.org/10.1186/s13063-020-04318-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251810PMC
May 2020

Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial.

Trials 2020 Apr 28;21(1):367. Epub 2020 Apr 28.

Department of Health Services Research, University of Liverpool, Block B Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.

Background: Asylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services. Their contact with health care is often crisis-driven and mediated through non-governmental organisations (NGOs). Problem Management Plus (PM+) is a psychosocial intervention recommended by the World Health Organisation to address distress experienced by adults affected by humanitarian crises. We are investigating its application for the first time in a high-income country.

Methods: In a pilot randomised controlled trial (RCT), PM+ will be delivered to AS&Rs in contact with NGOs in Liverpool City Region, UK by lay therapists who have lived experience of forced migration. Following systematic review and stakeholder engagement, PM+ has been adapted to the local context, and lay therapists have been trained in its delivery. We will assess the feasibility of conducting a three-arm RCT of five 90-min sessions of PM+, delivered individually or in groups by lay therapists to AS&Rs experiencing emotional distress and functional impairment, compared with each other and with usual support offered by local NGOs. Distress and impairment at baseline will be measured by the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule (WHO-DAS). We aim to recruit 105 participants, 35 per arm. Primary health outcomes are anxiety and depressive symptoms at 3 months, measured by HADS. Secondary outcomes include subjective wellbeing, functional status, progress on identified problems, presence of post-traumatic stress disorder and depressive disorder and service usage. Longer-term impact will be assessed at 6 months post baseline, on the same parameters. We will assess the feasibility of conducting a full RCT in relation to the following elements: recruitment and retention of lay therapists and study participants; fidelity of delivery of PM+; and suitability of the study measures, including any linguistic or cultural barriers.

Discussion: We will use these findings to specify the parameters for a full RCT to test the effectiveness and cost-effectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees.

Trial Registration: ISRCTN, ID: ISRCTN15214107. Registered on 10 September 2019.
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http://dx.doi.org/10.1186/s13063-020-04310-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7189505PMC
April 2020

Outcomes of abstracts presented at IADR general meetings in 2014 and 2015.

Br Dent J 2020 Apr;228(8):631-636

Department of Biostatistics, University of Liverpool, Brownlow Street, Liverpool, L69 3GL, UK.

Introduction Abstract presentations at scientific meetings provide a platform to share and discuss new research. It would be desirable if the abstracts were subsequently published in peer-reviewed journals as this is the most accepted method to allow the dissemination of scientific research.Aims To determine the publication rate of abstracts presented at the International Association for Dental Research (IADR) general sessions in 2014 and 2015, and factors involved from presentation to publication.Design A systematic search of PubMed and Google Scholar databases was performed of the abstracts identified. Abstract titles, author's last name and key words were used to identify whether an abstract resulted in a publication. Abstracts published in full-length articles were then analysed.Results There were a total number of 5,847 abstracts presented at 2014 and 2015 IADR general sessions. 60.9% of posters presented and 72.1% of oral presentations were consecutively published as a full-length article. The average publication rate of abstracts was 63.3%. USA had the highest number of published abstracts with a publication rate of 64.9%, followed by Brazil and Japan which had 62.3% and 67.9%, respectively. The mean time from presentation to publication was 13 months.Conclusion There is scope for further guidance to ensure scientific work is properly disseminated and published.
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http://dx.doi.org/10.1038/s41415-020-1371-7DOI Listing
April 2020

Mobile Health Technology to Improve Care for Patients With Atrial Fibrillation.

J Am Coll Cardiol 2020 04;75(13):1523-1534

Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom, and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address:

Background: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines, and lack of consideration of patients' preferences, thus highlighting the need for a more holistic and integrated approach to AF management.

Objective: The objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care.

Methods: This is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk.

Results: There were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of 'ischemic stroke/systemic thromboembolism, death, and rehospitalization' were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05).

Conclusions: An integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138).
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http://dx.doi.org/10.1016/j.jacc.2020.01.052DOI Listing
April 2020

A group intervention to improve quality of life for people with advanced dementia living in care homes: the Namaste feasibility cluster RCT.

Health Technol Assess 2020 01;24(6):1-140

International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.

Background: People with advanced dementia who live and die in nursing homes experience variable quality of life, care and dying. There is a need to identify appropriate, cost-effective interventions that facilitate high-quality end-of-life care provision.

Objectives: To establish the feasibility and acceptability to staff and family of conducting a cluster randomised controlled trial of the Namaste Care intervention for people with advanced dementia in nursing homes.

Design: The study had three phases: (1) realist review and (2) intervention refinement to inform the design of (3) a feasibility cluster randomised controlled trial with a process evaluation and economic analysis. Clusters (nursing homes) were randomised in a 3 : 1 ratio to intervention or control (usual care). The nature of the intervention meant that blinding was not possible.

Setting: Nursing homes in England providing care for people with dementia.

Participants: Residents with advanced dementia (assessed as having a Functional Assessment Staging Test score of 6 or 7), their informal carers and nursing home staff.

Intervention: Namaste Care is a complex group intervention that provides structured personalised care in a dedicated space, focusing on enhancements to the physical environment, comfort management and sensory engagement.

Main Outcome Measures: The two contender primary outcome measures were Comfort Assessment in Dying - End of Life Care in Dementia for quality of dying (dementia) and Quality of Life in Late Stage Dementia for quality of life. The secondary outcomes were as follows: person with dementia, sleep/activity (actigraphy), neuropsychiatric symptoms, agitation and pain; informal carers, satisfaction with care at the end of life; staff members, person-centred care assessment, satisfaction with care at the end of life and readiness for change; and other data - health economic outcomes, medication/service use and intervention activity.

Results: Phase 1 (realist review; 86 papers) identified that a key intervention component was the activities enabling the development of moments of connection. In phase 2, refinement of the intervention enabled the production of a user-friendly 16-page A4 booklet. In phase 3, eight nursing homes were recruited. Two homes withdrew before the intervention commenced; four intervention and two control homes completed the study. Residents with advanced dementia ( = 32) were recruited in intervention ( = 18) and control ( = 14) homes. Informal carers (total,  = 12: intervention,  = 5; control,  = 7) and 97 staff from eight sites (intervention,  = 75; control,  = 22) were recruited over a 6-month period. Recruitment is feasible. Completion rates of the primary outcome questionnaires were high at baseline (100%) and at 4 weeks (96.8%). The Quality of Life in Late Stage Dementia was more responsive to change over 24 weeks. Even where economic data were missing, these could be collected in a full trial. The intervention was acceptable; the dose varied depending on the staffing and physical environment of each care home. Staff and informal carers reported changes for the person with dementia in two ways: increased social engagement and greater calm. No adverse events related to the intervention were reported.

Conclusions: A subsequent definitive trial is feasible if there are amendments to the recruitment process, outcome measure choice and intervention specification.

Future Work: In a full trial, consideration is needed of the appropriate outcome measure that is sensitive to different participant responses, and of clear implementation principles for this person-centred intervention in a nursing home context.

Trial Registration: Current Controlled Trials ISRCTN14948133.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 6. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008353PMC
January 2020

Teaching orthodontic emergencies using the "flipped classroom" method of teaching-A mixed methods RCT.

Eur J Dent Educ 2020 Feb 26;24(1):53-62. Epub 2019 Sep 26.

Department of Orthodontics, Liverpool University Dental Hospital, Liverpool, UK.

Introduction: In the United Kingdom, the General Dental Council requires newly graduated dentists to be competent in managing orthodontic emergencies. Undergraduate students typically receive limited exposure to orthodontics, with teaching primarily delivered via conventional lectures. Flipped teaching involves knowledge being acquired in students' own time, with class time focussing on construction of meaning.

Methods: A total of 61 undergraduate dental students were randomised into either a flipped or a conventional group. The conventional group (n = 30) attended a lecture describing the management of six common emergencies. The flipped group (n = 31) were given access to six videos via a virtual learning environment and later completed practical tasks related to the material. Both groups completed a single best answer assessment. Perceptions of flipped classroom teaching were explored via focus groups.

Results: For questions on orthodontic emergencies, the conventional group had a mean examination result of 70.5% (SD 8.0%) compared with the flipped group of 72.8% (SD 12.9%). There was no significant difference between the groups (P = .532). For regular orthodontic questions, the conventional group had a mean examination result of 64.8% (SD: 19.9%) compared with 78.3% (SD: 21.7%). There was no significant difference between the groups (P = .083). Thematic analysis identified the following themes: ways in which videos encourages more effective learning, improved engagement, awareness of learning needs and proposed teaching/curriculum changes. The overarching theoretical perspective was facilitating an experiential learning cycle using flipped classroom teaching.

Conclusions: In the context of this investigation, the flipped classroom method of teaching resulted in comparable examination performance and improved levels of satisfaction.
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http://dx.doi.org/10.1111/eje.12467DOI Listing
February 2020

Development of a patient reported outcome measures for measuring the impact of visual impairment following stroke.

BMC Health Serv Res 2019 May 31;19(1):348. Epub 2019 May 31.

Department of Biostatistics, University of Liverpool, Waterhouse Building Block F, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.

Background: Among the available patient-reported outcome measures (PROMs) there is an absence of a PROM with a specific focus on the impact of the wide variety of visual impairments following stroke. Our aim was to develop a patient reported quality of life outcome measure for stroke survivors with visual impairment.

Methods: Potential items were sourced from a combination of existing PROMs from a systematic review and qualitative in-depth interviews, duplicates were removed and items shortlisted. The initial pilot instrument was created following a ranking exercise of these potential items and consultation with stroke survivors. Version 1 was piloted with 37 stroke survivors at acute and chronic stages. Version 2 was piloted with 243 stroke survivors with visual impairment at acute and chronic stages. This data was analysed using the Rasch measurement model. Simultaneously, items from Version 2 underwent a Delphi process with stroke survivors and stroke clinicians, to assess the importance of each item. Final consensus decisions on item removal were made using the combined analysis from the Rasch measurement model and Delphi process in a nominal group meeting.

Results: Due to the wide range of rank given to the majority of categories/items, only two items were discarded. Version 1 comprised of 102 items with 5 response categories relating to amount of difficulty. The pilot of Version 1 allowed item reduction based on analysis of floor/ceiling effects and not applicable responses. Version 2 comprised of 62 items. Within the nominal group meeting, the expert panel created a set of rules which aided them with decision making in addition to the Rasch and Delphi analysis data. This resulted in the removal of 43 items and the combination of seven items to create three new items. The expert panel also recommended the rewording of three items.

Conclusion: The Brain Injury associated Visual Impairment Impact Questionnaire (BIVI-IQ-15), a 15-item instrument with 4 response categories has been developed for capturing vision-related quality of life of stroke survivors with any of the predominant types of visual impairment, in the presence of other impairments and for both inpatients and outpatients.
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http://dx.doi.org/10.1186/s12913-019-4157-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6544926PMC
May 2019

Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery.

J Clin Epidemiol 2019 09 20;113:28-35. Epub 2019 May 20.

Department of Biostatistics, University of Liverpool, A member of Liverpool Health Partners, Liverpool, UK; North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.

Objective: The objective of this study was to provide insight into current practice in planning for, and acknowledging, the presence of learning and clustering effects, by treating center and surgeon, when developing randomized surgical trials.

Study Design And Setting: Complexities associated with delivering surgical interventions, such as clustering effects, by center or surgeon, and surgical learning should be considered at trial design. Main trial publications, within the wider literature, under-report these considerations. Funded applications, within a 4-year period, from a leading UK funding body were searched. Data were extracted on considerations for learning and clustering effects and the driver, funder, or applicant, behind these.

Results: Fifty trials were eligible. Managing learning through establishing predefined center and surgeon credentials was common. One planned exploratory analysis of learning within center, and two within surgeon. Clustering, by site and surgeon, was often managed through stratifying randomization, with 81% and 60%, respectively, also planning to subsequently adjust analysis. One-third of responses to referees contained funder led changes accounting for learning and/or clustering.

Conclusion: This review indicates that researchers do consider impact of learning and clustering, by center and surgeon, during trial development. Furthermore, the funder is identified as a potential driver of considerations.
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http://dx.doi.org/10.1016/j.jclinepi.2019.05.007DOI Listing
September 2019

Patient-delivered tDCS on chronic neuropathic pain in prior responders to TMS (a randomized controlled pilot study).

J Pain Res 2018 10;11:3117-3128. Epub 2018 Dec 10.

The Pain Research Institute, Faculty of Health and Life Sciences, Clinical Sciences Centre, University of Liverpool, Liverpool, UK,

Background: Successful response to repetitive transcranial magnetic stimulation (rTMS) of the motor cortex requires continued maintenance treatments. Transcranial Direct Current Stimulation (tDCS) may provide a more convenient alternative.

Methods: This pilot study aimed to examine the feasibility of a randomized, double-blind, double-crossover pilot study for patients to self-administer tDCS motor cortex stimulation for 20 minutes/day over five consecutive days. Primary outcomes were as follows: usability of patient-administered tDCS, compliance with device, recruitment, and retention rates. Secondary outcomes were as follows: effect on overall pain levels and quality of life via Short Form-36 anxiety and depression via Hospital Anxiety and Depression Scale, and Mini-Mental State scores.

Results: A total of 24 subjects with neuropathic pain, who had previously experienced rTMS motor cortex stimulation (13 with reduction in pain scores, 11 nonresponders) were recruited at the Pain Research Institute, Fazakerley, UK. A total of 21 subjects completed the study. Recruitment rate was 100% but retention rate was only 87.5%. All patients reported satisfactory usability of the tDCS device. No significant difference was shown between Sham vs Anodal (-0.16, 95% CI: -0.43 to 0.11) =0.43, Sham vs Cathodal (0.11, 95% CI: -0.16 to 0.37) =0.94, or Cathodal vs Anodal (-0.27, 95% CI: -0.54 to 0.00) =0.053 treatments. Furthermore, no significant changes were demonstrated in anxiety, depression, or quality of life measurements. The data collected to estimate sample size for a definitive study suggested that the study's sample size was already large enough to detect a change of 15% in pain levels at 90% power for the overall group of 21 patients.

Conclusion: This study did not show a beneficial effect of tDCS in this group of patients and does not support the need for a larger definitive study using the same experimental paradigm.

Trial Registration: ISRCTN56839387.
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http://dx.doi.org/10.2147/JPR.S186079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292397PMC
December 2018

Higher number of items associated with significantly lower response rates in COS Delphi surveys.

J Clin Epidemiol 2019 04 15;108:110-120. Epub 2018 Dec 15.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.

Objectives: The Delphi method is commonly used to achieve consensus in core outcome set (COS) development. It is important to try to maximize response rates to Delphi studies and minimize attrition rates and potential for bias. The factors that impact response rates in a Delphi study used for COS development are unknown. The objective of this study was to explore the impact of design characteristics on response rates in Delphi surveys within COS development.

Methods: Published and ongoing studies that included Delphi to develop a COS were eligible. Second round voting response rates were analyzed, and multilevel linear regression was conducted to investigate whether design characteristics were associated with the response rate.

Results: Thirty-one studies were included. Two characteristics were significantly associated with a lower response rate: larger panels and studies with more items included.

Conclusion: COS developers should pay attention to methods when designing a COS development study; in particular, the size of the panels and the size of the list of outcomes. We identified other potential design characteristics that might influence response rates but were unable to explore them in this analysis. These should be reported in future reports to allow for further investigation.
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http://dx.doi.org/10.1016/j.jclinepi.2018.12.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438267PMC
April 2019

Namaste Care in nursing care homes for people with advanced dementia: protocol for a feasibility randomised controlled trial.

BMJ Open 2018 11 25;8(11):e026531. Epub 2018 Nov 25.

International Observatory on End of Life Care, Lancaster University, Lancaster, UK.

Introduction: Many people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention.

Methods And Analysis: A feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers.

Ethics And Dissemination: This protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications.

Trial Registration Number: ISRCTN14948133; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-026531DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6254402PMC
November 2018

Randomized trials involving surgery did not routinely report considerations of learning and clustering effects.

J Clin Epidemiol 2019 03 13;107:27-35. Epub 2018 Nov 13.

Department of Biostatistics, University of Liverpool, Liverpool, UK; North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.

Objectives: To establish current practice of the management of learning and clustering effects, by treating center and surgeon, in the design and analysis of randomized surgical trials.

Study Design And Setting: The need for more surgical randomized trials is well recognized, and in recent years conduct has grown. Rigorous design, conduct, and analyses of such studies is important. Two methodological challenges are clustering effects, by center or surgeon, and surgical learning on trial outcomes. Sixteen leading journals were searched for randomized trials published within a two-year period. Data were extracted on considerations for learning and clustering effects.

Results: A total of 247 eligible studies were identified. Trials accounted for learning with 2% using an expertise-based design and 39% accounting for expertise by predefining surgeon credentials. One study analyzed learning. Clustering, by site and surgeon, was commonly managed by stratifying randomization, although one-third of center and 40% of surgeon stratified trials did not also adjust analysis.

Conclusion: Considerations for surgical learning and clustering effects are often unclear. Methods are varied and demonstrate poor adherence to established reporting guidelines. It is recommended that researchers consider these issues on a trial-by-trial basis, and report methods or justify where not needed to inform interpretation of results.
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http://dx.doi.org/10.1016/j.jclinepi.2018.11.004DOI Listing
March 2019

Comparison of statural height growth velocity at different cervical vertebral maturation stages.

Am J Orthod Dentofacial Orthop 2018 Oct;154(4):545-553

Liverpool University Dental Hospital and School of Dentistry, Liverpool, United Kingdom. Electronic address:

Introduction: Knowledge of a patient's stage of growth and development plays a vital role in diagnosis, treatment planning, results, and stability of the outcome. Cervical vertebral maturation (CVM) predicts the stage of growth and development, but its validity has only been investigated restrospectively, using historic samples. Our objective was to assess prospectively whether a correlation exists between CVM stage and statural height growth velocity.

Methods: Participants were aged between 8 and 18 years and of both sexes. Standing height was measured every 6 weeks with participants barefoot and in natural head position. CVM stage was assessed from lateral cephalograms taken at the start of treatment. Intraobserver and interobserver reliability of CVM staging and statural height measurements were assessed using the Cohen weighted kappa, percentage of agreement, intraclass correlation coefficient, and Bland-Altman plots, respectively. Analysis of variance was used to test for statistically significant differences between growth velocities at the CVM stages.

Results: We analyzed 108 participants. The peak in statural height growth velocity occurred at CVM stage 3 (P = 0.001). There was a statistically significant difference in the mean annualized growth velocity between all CVM stages except stages 2 and 4. Girls had their peak pubertal growth spurt an average of 1.2 years earlier than did boys.

Conclusions: This study suggests that there is a significant relationship between CVM stage and statural height velocity.
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http://dx.doi.org/10.1016/j.ajodo.2017.12.016DOI Listing
October 2018

Nerve root block versus surgery (NERVES) for the treatment of radicular pain secondary to a prolapsed intervertebral disc herniation: study protocol for a multi-centre randomised controlled trial.

Trials 2018 Sep 5;19(1):475. Epub 2018 Sep 5.

Clinical Trials Research Centre, University of Liverpool, Liverpool, L12 2AP, UK.

Background: Sciatica is a common condition reported to affect over 3% of the UK population at any time and is often caused by a prolapsed intervertebral disc (PID). Although the duration and severity of symptoms can vary, pain persisting beyond 6 weeks is unlikely to recover spontaneously and may require investigation and treatment. Currently, there is no specific care pathway for sciatica in the National Health Service (NHS), and no direct comparison exists between surgical microdiscectomy and transforaminal epidural steroid injection (TFESI). The NERVES (NErve Root block VErsus Surgery) trial aims to address this by comparing clinical and cost-effectiveness of surgical microdiscectomy and TFESI to treat sciatica secondary to a PID.

Methods/design: A total of 163 patients were recruited from NHS out-patient clinics across the UK and randomised to either microdiscectomy or TFESI. Adult patients (aged 16-65 years) with sciatic pain endured for between 6 weeks and 12 months are eligible if their symptoms have not been improved by at least one form of conservative (non-operative) treatment and they are willing to provide consent. Patients will be excluded if they present with neurological deficit or have had previous surgery at the same level. The primary outcome is patient-reported disability measured using the Oswestry Disability Questionnaire (ODQ) score at 18 weeks post randomisation and secondary outcomes include disability and pain scales using numerical pain ratings, modified Roland-Morris and Core Outcome Measures Index at 12-weekly intervals, and patient satisfaction at 54 weeks. Cost-effectiveness and quality of life (QOL) will be assessed using the EQ-5D-5 L and self-report cost data at 12-weekly intervals and Hospital Episode Statistics (HES) data. Adverse event data will be collected. Analysis will follow the principle of intention-to-treat.

Discussion: NERVES is the first trial to evaluate the comparative clinical and cost-effectiveness of microdiscectomy to local anaesthetic and steroid administered via TFESI. The results of this research may facilitate the development of an evidence-based treatment strategy for patients with sciatica.

Trial Registration: ISRCTN, ID: ISRCTN04820368 . Registered on 5 June 2014. EudraCT EudraCT2014-002751-25. Registered on 8 October 2014.
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http://dx.doi.org/10.1186/s13063-018-2677-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6126032PMC
September 2018

Presenting information on dental risk: PREFER study protocol for a randomised controlled trial involving patients receiving a dental check-up.

Contemp Clin Trials Commun 2018 Sep 7;11:1-9. Epub 2018 May 7.

School of Dental Sciences, Newcastle University, Newcastle-upon-Tyne, Tyne and Wear, UK.

Introduction: A new dental contract being tested in England places patients into traffic light categories according to risk (Red = High risk). This reflects health policy which emphasises patients' shared responsibility for their health, and a growing expectation that clinicians discuss health risk in consultations. Alongside this, there are technological developments such as scans and photographs which have generated new, vivid imagery which may be used to communicate risk information to patients. However, there is little evidence as to whether the form in which risk information is given is important.

Methods: The PREFER study is a pragmatic, multi-centre, three-arm, patient-level randomised controlled trial, based in four NHS dental practices, from which 400 high/medium risk patients will be recruited. The study compares three ways of communicating risk information at dental check-ups: 1) verbal only (usual care); 2) a Traffic Light graphic with verbal explanation; 3) a Quantitative Light-Induced Fluorescence (QLF) photograph showing, for example, patches of red fluorescence where dental plaque has been present for two days or more (with a verbal explanation). The study assesses patient preferences using the economic preference-based valuation methodology Willingness-to-Pay (WTP). Any changes in oral self-care (for example in tooth-brushing), will be measured by self-report, and clinical outcome data collected by clinicians and extracted from QLF photographs. Predictors and moderators of any behaviour change will be explored using demographic characteristics and psychological variables from the Extended Parallel Process Model. A cost-benefit framework will explore the financial implications for NHS dentistry of the three risk presentation methods.
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http://dx.doi.org/10.1016/j.conctc.2018.05.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6022252PMC
September 2018

The Scottish Orthodontic Peer Review project: the outcome of treatment and standard of record keeping by orthodontic specialist practitioners in Scotland.

J Orthod 2018 09 4;45(3):176-185. Epub 2018 Jun 4.

d Glasgow Orthodontics , Glasgow , UK.

Objectives: Assess occlusal outcomes of treatment and clinical record keeping in specialist practice in Scotland.

Design: A retrospective cohort study.

Setting: Specialist practices in Scotland.

Participants: Specialist orthodontists in Scotland.

Methods: Every specialist practitioner in Scotland (51) was invited to take part in the peer review project with 38 (76%) enrolled. Scotland was split into four geographical areas, and each practitioner matched with a colleague from the same area. Practitioners took one day to visit their colleague and score 30 consecutively treated NHS cases using the Peer Assessment Rating (PAR) index. They also assessed the quality of the records taken. Practitioners then swapped roles and assessed their partner's occlusal outcomes and records.

Results: The mean pretreatment PAR score was 28.6 (SD 3.5). Mean posttreatment PAR score was 3.5 (SD 1.2). Mean reduction in PAR score was 25.1 (SD 3.8). Mean percentage PAR score reduction was 87.7% (SD 3.7%). Overall record keeping scores were written records 100%, study models 99.5%, Orthopantomogram radiograph 99.2%, photographs 86.3%, medical history 75% and consent 40.8%.

Conclusions: Occlusal outcomes achieved by specialist practitioners in Scotland were of a high standard. They maintained a good standard of clinical record collection in most areas examined.
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http://dx.doi.org/10.1080/14653125.2018.1467653DOI Listing
September 2018

Is tonsillectomy mandatory for asymmetric tonsils in children? A review of our diagnostic tonsillectomy practice and the literature.

Int J Pediatr Otorhinolaryngol 2018 Jul 1;110:57-60. Epub 2018 May 1.

Otolaryngology Department, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP, UK.

Introduction: Diagnostic tonsillectomy is performed to exclude malignancy. It is associated with a post-operative hemorrhage rate of 3.5%, (1) which is more dangerous in small children. No previous case series for asymmetrical tonsils have detected tonsil lymphoma.(2-6) We aimed to review our local diagnostic tonsillectomy practice.

Method: The authors reviewed the clinical notes and histological results for all diagnostic tonsillectomies carried out from June 2013 to June 2016.

Results: We recorded data for 168 patients. There were four post-operative bleeds and one return to theatre. Bilateral tonsillectomies accounted for 152 operations (90.5%). Lymphoid hyperplasia accounted for 95% of histological diagnosis with no malignancies found. Pre-operative tonsil grading demonstrated no statistically significant association with histological tonsil weight difference (ANOVA p = 0.10). Actinomyces colonisation had little affect on tonsil weight difference when we compared patients with bilateral colonisation and no colonisation (t-test p = 0.540) and between tonsils in patients with unilateral tonsil Actinomyces colonisation (paired t-test p = 0.448). Recurrent tonsillitis was more prevalent in patients with Actinomyces colonisation than OSA/sleep disordered breathing (39% vs 15%).

Conclusion: A literature search yielded five smaller case series of palatine tonsil asymmetry in children with no malignancy found.(2-6) Case-control studies report tonsillar asymmetry as the most common presenting symptom (73%) in tonsillar lymphoma.(7) This enlargement usually occurs rapidly within 6 weeks with new obstructive or systemic B-type symptoms.(3) A Turkish epidemiological study found asymmetrical tonsils in 1.7% of the healthy paediatric population.(8) We therefore estimate there to be over 210,000 children with asymmetrical tonsils in the UK. With an unreliable grading system, we believe asymmetrical tonsils in isolation, unchanged for over 6 weeks may not warrant tonsillectomy.
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http://dx.doi.org/10.1016/j.ijporl.2018.04.027DOI Listing
July 2018

The spectrum of neurological disease associated with Zika and chikungunya viruses in adults in Rio de Janeiro, Brazil: A case series.

PLoS Negl Trop Dis 2018 02 12;12(2):e0006212. Epub 2018 Feb 12.

National Institute for Health Research Health Protection Research Unit in Emerging and Zoonotic Infections, University of Liverpool, Liverpool, United Kingdom.

Background: During 2015-16 Brazil experienced the largest epidemic of Zika virus ever reported. This arthropod-borne virus (arbovirus) has been linked to Guillain-Barré syndrome (GBS) in adults but other neurological associations are uncertain. Chikungunya virus has caused outbreaks in Brazil since 2014 but associated neurological disease has rarely been reported here. We investigated adults with acute neurological disorders for Zika, chikungunya and dengue, another arbovirus circulating in Brazil.

Methods: We studied adults who had developed a new neurological condition following suspected Zika virus infection between 1st November 2015 and 1st June 2016. Cerebrospinal fluid (CSF), serum, and urine were tested for evidence of Zika, chikungunya, and dengue viruses.

Results: Of 35 patients studied, 22 had evidence of recent arboviral infection. Twelve had positive PCR or IgM for Zika, five of whom also had evidence for chikungunya, three for dengue, and one for all three viruses. Five of them presented with GBS; seven had presentations other than GBS, including meningoencephalitis, myelitis, radiculitis or combinations of these syndromes. Additionally, ten patients positive for chikungunya virus, two of whom also had evidence for dengue virus, presented with a similar range of neurological conditions.

Conclusions: Zika virus is associated with a wide range of neurological manifestations, including central nervous system disease. Chikungunya virus appears to have an equally important association with neurological disease in Brazil, and many patients had dual infection. To understand fully the burden of Zika we must look beyond GBS, and also investigate for other co-circulating arboviruses, particularly chikungunya.
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http://dx.doi.org/10.1371/journal.pntd.0006212DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5837186PMC
February 2018

Treating vitamin D deficiency in children with type I diabetes could improve their glycaemic control.

BMC Res Notes 2017 Sep 7;10(1):465. Epub 2017 Sep 7.

Department of Paediatric Endocrinology & Diabetes, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.

Background And Aims: The relationship between vitamin D deficiency and type I DM is an ongoing area of interest. The study aims to identify the prevalence of vitamin D deficiency in children and adolescents with T1DM and to assess the impact of treatment of vitamin D deficiency on their glycaemic control.

Methods: Retrospective data was collected from 271 children and adolescents with T1DM. The vitamin D deficient (25(OH)D <30 nmol/L) and insufficient (25(OH)D 30-50 nmol/L) patients were treated with 6000 units of cholecalciferol and 400 units of cholecalciferol, once daily for 3 months respectively. HbA1c and 25(OH)D concentrations were measured before and at the end of the vitamin D treatment.

Results: 14.8% from the whole cohort (n = 271) were vitamin D deficient and 31% were insufficient. Among the children included in the final analysis (n = 73), the mean age and plasma 25(OH)D concentration (±SD) were 7.7 years (±4.4) and 32.2 nmol/l (±8.2) respectively. The mean 25(OH)D concentration post-treatment was 65.3 nmol/l (±9.3). The mean HbA1c (±SD) before and after cholecalciferol was 73.5 mmol/mol (±14.9) and 65 mmol/mol (±11.2) respectively (p < 0.001). Children with higher pre-treatment HbA1c had greater reduction in HbA1c (p < 0.001) and those with lower 25(OH)D concentration showed higher reduction in HbA1c (p = 0.004) after treatment.

Conclusions: Low 25(OH)D concentrations are fairly prevalent in children and adolescents with T1DM, treatment of which, can potentially improve the glycaemic control.
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http://dx.doi.org/10.1186/s13104-017-2794-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5590233PMC
September 2017

A randomised controlled trial to investigate the remineralising potential of Tooth Mousse™ in orthodontic patients.

J Orthod 2017 09 6;44(3):147-156. Epub 2017 Jul 6.

b Health Services Research and School of Dentistry , University of Liverpool , Liverpool , UK.

Objective: To investigate the remineralisation of enamel subsurface lesions treated with fluoride toothpaste (1450 ppm) or a combination of fluoride toothpaste in addition to Tooth Mousse™.

Design: An in situ, cross-over, randomised controlled trial.

Setting: Orthodontic department at Liverpool University Dental Hospital, UK.

Participants: Twelve patients receiving fixed orthodontic treatment.

Methods: Demineralised subsurface enamel lesions were placed in a carrier and attached onto a fixed orthodontic appliance. Interventions were either standard fluoride toothpaste or CPP-ACP paste (Tooth Mousse™) in addition to the fluoride toothpaste. Participants received both interventions in a randomised order. Transverse microradiography analysis was used to compare lesion mineral content profiles.

Results: Mineral loss was reduced by 15.4 and 24.6% between the fluoride and CPP-ACP groups, respectively (p = 0.023). Lesion depth was reduced by 1.6 and 11.1% between the fluoride and CPP-ACP groups, respectively (p = 0.037). Lesion width was reduced by 4.5 and 15.3% between the fluoride and CPP-ACP groups, respectively (p = 0.015).

Conclusions: Remineralisation occurred regardless of treatment group allocation. However, the addition of Tooth Mousse™ resulted in a significantly increased remineralisation effect, compared to fluoride alone. Tooth Mousse™ may be beneficial for patients undergoing orthodontic treatment who are at high risk of demineralisation.

Trial Registration: Registered on Current Control Trials http://www.controlled-trials.com/ISRCTN04899524.
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http://dx.doi.org/10.1080/14653125.2017.1341729DOI Listing
September 2017