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Article ; Online: Effectiveness of oral care interventions on malodour in dogs.

Croft, Julie M / Patel, Krusha V / Inui, Taichi / Ruparell, Avika / Staunton, Ruth / Holcombe, Lucy J

2022 Volume 18, Issue 1, Page(s) 164

Abstract: Background: Oral malodour is identified by pet owners as an unpleasant inconvenience, but they may not recognise this likely indicates underlying disease. The primary cause of oral malodour relates to the presence of bacteria in the oral cavity often ... ...

Abstract	Background: Oral malodour is identified by pet owners as an unpleasant inconvenience, but they may not recognise this likely indicates underlying disease. The primary cause of oral malodour relates to the presence of bacteria in the oral cavity often associated with gingivitis and periodontitis. The purpose of this study was to determine the effect of feeding two oral care chews with different textural properties on oral malodour and the proportion of bacterial species involved in the production of volatile sulphur compounds (VSCs). Methods: Fourteen dogs (9 Petit Basset Griffon Vendéen (PBGV) and 5 Beagle dogs) participated in the randomised cross-over study for a total of 14 weeks. The cohort was divided into four groups with each exposed to a different intervention per week: chew A, chew B, tooth brushing control or a no intervention control. An induced malodour method was used to assess VSCs in breath samples using a portable gas chromatograph (OralChroma™). Microbiological samples (supragingival plaque and tongue coating scrapes) were analysed for VSC-producing bacteria using Oral Hydrogen Sulfide agar with lead acetate. Results: VSCs were detected in the dogs' breath samples and levels of hydrogen sulphide and methyl mercaptan were found to be reduced following an intervention. Chew B significantly reduced the levels of both hydrogen sulphide (p < 0.001) and methyl mercaptan (p < 0.05) compared to no intervention. Reductions in methyl mercaptan were also observed for chew A and tooth brushing but these were not statistically significant. When compared to no intervention, all interventions significantly reduced the total bacterial load and VSC producing bacterial load in plaque (p < 0.001). For tongue samples, only chew B significantly reduced the total bacterial load and VSC-producing bacterial load (p < 0.001) compared to no intervention. Conclusions: By inducing oral malodour and subsequently applying the one-time interventions, significant reductions in the levels of VSCs were observed. The use of oral care chews texturally designed to deliver a deep, all-round cleaning action can be particularly effective at managing oral malodour in dogs, likely through an enhanced ability to remove bacteria.
MeSH term(s)	Animals ; Dogs ; Cross-Over Studies ; Halitosis/microbiology ; Halitosis/therapy ; Halitosis/veterinary ; Hydrogen Sulfide ; Sulfhydryl Compounds/analysis ; Sulfur Compounds/analysis
Chemical Substances	Hydrogen Sulfide (YY9FVM7NSN) ; Sulfhydryl Compounds ; Sulfur Compounds
Language	English
Publishing date	2022-05-05
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial, Veterinary
ZDB-ID	2191675-5
ISSN	1746-6148 ; 1746-6148
ISSN (online)	1746-6148
ISSN	1746-6148
DOI	10.1186/s12917-022-03267-8
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Article ; Online: Effectiveness of oral care interventions on malodour in dogs

Croft, Julie M. / Patel, Krusha V. / Inui, Taichi / Ruparell, Avika / Staunton, Ruth / Holcombe, Lucy J.

BMC Vet Res. 2022 Dec., v. 18, no. 1 p.164-164

2022

Abstract: BACKGROUND: Oral malodour is identified by pet owners as an unpleasant inconvenience, but they may not recognise this likely indicates underlying disease. The primary cause of oral malodour relates to the presence of bacteria in the oral cavity often ... ...

Abstract	BACKGROUND: Oral malodour is identified by pet owners as an unpleasant inconvenience, but they may not recognise this likely indicates underlying disease. The primary cause of oral malodour relates to the presence of bacteria in the oral cavity often associated with gingivitis and periodontitis. The purpose of this study was to determine the effect of feeding two oral care chews with different textural properties on oral malodour and the proportion of bacterial species involved in the production of volatile sulphur compounds (VSCs). METHODS: Fourteen dogs (9 Petit Basset Griffon Vendéen (PBGV) and 5 Beagle dogs) participated in the randomised cross-over study for a total of 14 weeks. The cohort was divided into four groups with each exposed to a different intervention per week: chew A, chew B, tooth brushing control or a no intervention control. An induced malodour method was used to assess VSCs in breath samples using a portable gas chromatograph (OralChroma™). Microbiological samples (supragingival plaque and tongue coating scrapes) were analysed for VSC-producing bacteria using Oral Hydrogen Sulfide agar with lead acetate. RESULTS: VSCs were detected in the dogs’ breath samples and levels of hydrogen sulphide and methyl mercaptan were found to be reduced following an intervention. Chew B significantly reduced the levels of both hydrogen sulphide (p < 0.001) and methyl mercaptan (p < 0.05) compared to no intervention. Reductions in methyl mercaptan were also observed for chew A and tooth brushing but these were not statistically significant. When compared to no intervention, all interventions significantly reduced the total bacterial load and VSC producing bacterial load in plaque (p < 0.001). For tongue samples, only chew B significantly reduced the total bacterial load and VSC-producing bacterial load (p < 0.001) compared to no intervention. CONCLUSIONS: By inducing oral malodour and subsequently applying the one-time interventions, significant reductions in the levels of VSCs were observed. The use of oral care chews texturally designed to deliver a deep, all-round cleaning action can be particularly effective at managing oral malodour in dogs, likely through an enhanced ability to remove bacteria.
Keywords	Beagle ; agar ; cross-over studies ; gas chromatography ; gingivitis ; halitosis ; hydrogen sulfide ; lead acetate ; methanethiol ; microbial load ; off odors ; periodontitis ; sulfur ; tongue
Language	English
Dates of publication	2022-12
Size	p. 164.
Publishing place	BioMed Central
Document type	Article ; Online
ZDB-ID	2191675-5
ISSN	1746-6148
ISSN	1746-6148
DOI	10.1186/s12917-022-03267-8
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Article ; Online: Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial).

Thomson, Simon / Ainsworth, Gemma / Selvanathan, Senthil / Brown, Sarah / Croft, Julie / Kelly, Rachel / Mujica-Mota, Ruben / Rousseau, Nikki / Higham, Ruchi / Stocken, Deborah

British journal of neurosurgery

2024 Volume 38, Issue 1, Page(s) 141–148

Abstract: Background: Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy ( ... ...

Abstract	Background: Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post-surgery. Method: Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described. Results: The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar. Conclusions: The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made.
MeSH term(s)	Humans ; Foraminotomy/methods ; Treatment Outcome ; Cost-Benefit Analysis ; Prospective Studies ; Cervical Vertebrae/surgery ; Spinal Fusion/methods ; Diskectomy/adverse effects ; Diskectomy/methods ; Radiculopathy/surgery
Language	English
Publishing date	2024-01-27
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	639029-8
ISSN	1360-046X ; 0268-8697
ISSN (online)	1360-046X
ISSN	0268-8697
DOI	10.1080/02688697.2023.2267119
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Article ; Online: Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) feasibility trial protocol: a multicentre, feasibility cohort study with embedded randomised control trial to compare sacral neuromodulation and transanal irrigation to optimised conservative management in the management of major low anterior resection syndrome following rectal cancer treatment.

Coxon-Meggy, Alexandra Harriet / Vogel, Irene / White, Judith / Croft, Julie / Corrigan, Neil / Meggy, Alun / Stocken, Deborah D / Keller, Deborah / Hompes, Roel / Knowles, Charles H / Quyn, Aaron / Cornish, Julie

BMJ open

2023 Volume 13, Issue 1, Page(s) e064248

Abstract: Introduction: Rectal cancer is common with a 60% 5-year survival rate. Treatment usually involves surgery with or without neoadjuvant chemoradiotherapy or adjuvant chemotherapy. Sphincter saving curative treatment can result in debilitating changes to ... ...

Abstract	Introduction: Rectal cancer is common with a 60% 5-year survival rate. Treatment usually involves surgery with or without neoadjuvant chemoradiotherapy or adjuvant chemotherapy. Sphincter saving curative treatment can result in debilitating changes to bowel function known as low anterior resection syndrome (LARS). There are currently no clear guidelines on the management of LARS with only limited evidence for different treatment modalities. Methods and analysis: Patients who have undergone an anterior resection for rectal cancer in the last 10 years will be approached for the study. The feasibility trial will take place in four centres with a 9-month recruitment window and 12 months follow-up period. The primary objective is to assess the feasibility of recruitment to the POLARiS trial which will be achieved through assessment of recruitment, retainment and follow-up rates as well as the prevalence of major LARS.Feasibility outcomes will be analysed descriptively through the estimation of proportions with confidence intervals. Longitudinal patient reported outcome measures will be analysed according to scoring manuals and presented descriptively with reporting graphically over time. Ethics and dissemination: Ethical approval has been granted by Wales REC1; Reference 22/WA/0025. The feasibility study is in the process of set up. The results of the feasibility trial will feed into the design of an expanded, international trial. Trial registration number: CT05319054.
MeSH term(s)	Humans ; Rectal Neoplasms/surgery ; Feasibility Studies ; Low Anterior Resection Syndrome ; Cohort Studies ; Conservative Treatment ; Postoperative Complications/therapy ; Electric Stimulation Therapy ; Quality of Life ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
Language	English
Publishing date	2023-01-10
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-064248
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Article ; Online: Recruiting to surgical trials in the emergency setting: using a mixed methods study to understand clinician and patient perspectives.

Twiddy, Maureen / Birtwistle, Jacqueline / Edmondson, Amanda / Croft, Julie / Gordon, Kathryn / Meads, David / Burke, Dermot / Griffiths, Ben / Rose, Azmina / Sagar, Peter / Stocken, Deborah / Brown, Julia M B / Harji, Deena

BJS open

2022 Volume 6, Issue 6

Abstract: Background: Undertaking randomized clinical trials (RCTs) in emergency surgical settings is associated with methodological and practical challenges. This study explored patients' and clinicians' perspectives associated with the conduct of an RCT ... ...

Abstract	Background: Undertaking randomized clinical trials (RCTs) in emergency surgical settings is associated with methodological and practical challenges. This study explored patients' and clinicians' perspectives associated with the conduct of an RCT comparing laparoscopic and open colorectal surgery in the acute setting. Methods: All eligible patients screened and enrolled for the 'Laparoscopic versus open colorectal surgery in the acute setting (LaCeS)' multicentre, randomized clinical feasibility trial in five UK NHS Trusts were invited to respond to a survey. Patients and healthcare professionals were also invited to take part in semi-structured interviews. Survey and interviews explored the acceptability of the feasibility trial. Interviews were audio recorded, transcribed verbatim, and analysed using thematic analysis. Survey data were analysed descriptively to assess patient views of the trial and intervention. Results: Out of 72 patients enrolled for the LaCeS RCT, survey data were collected from 28 patients (38.9 per cent), and interviews were conducted with 16 patients and 14 healthcare professionals. Thirteen out of 28 patients (46 per cent) had treatment preferences but these were not strong enough to deter participation. Twelve of the patients interviewed believed that their surgeon preferred laparoscopic surgery, but this did not deter them from participating in the trial. Half of the surgeons interviewed expressed the view that laparoscopic surgery was of benefit in this setting, but recognized that the need for research evidence outweighed their personal treatment preferences. Eight of the 14 recruiters reported that the emergency setting affected recruitment, especially in centres with fewer recruiting surgeons. Interviewees reported that recruitment was helped significantly by using surgical trainees to consent patients. Conclusion: This study identified specific challenges for the LaCeS trial design to address and adds significant insights to our understanding of recruiting to emergency surgical trials more broadly.
MeSH term(s)	Humans ; Qualitative Research ; Patient Selection ; Surgeons ; Colorectal Surgery ; Attitude of Health Personnel
Language	English
Publishing date	2022-12-19
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2474-9842
ISSN (online)	2474-9842
DOI	10.1093/bjsopen/zrac137
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Article ; Online: The Incidence of Low Anterior Resection Syndrome as Assessed in an International Randomized Controlled Trial (MRC/NIHR ROLARR).

Bolton, William S / Chapman, Stephen J / Corrigan, Neil / Croft, Julie / Collinson, Fiona / Brown, Julia M / Jayne, David G

Annals of surgery

2020 Volume 274, Issue 6, Page(s) e1223–e1229

Abstract: Objective: To investigate the incidence of LARS in patients undergoing elective anterior resection within the MRC/NIHR ROLARR trial and to explore perioperative variables that might be associated with major LARS.: Summary background data: Sphincter- ... ...

Abstract	Objective: To investigate the incidence of LARS in patients undergoing elective anterior resection within the MRC/NIHR ROLARR trial and to explore perioperative variables that might be associated with major LARS. Summary background data: Sphincter-preserving rectal cancer surgery is frequently accompanied by defaecatory dysfunction known as Low anterior resection syndrome (LARS). This is distressing for patients and is an unmet clinical challenge. Methods: An international, retrospective cohort study of patients undergoing anterior resection within the ROLARR trial was undertaken. Trial participants with restoration of gastrointestinal continuity and free from disease recurrence completed the validated LARS questionnaire between August 2015 and April 2017. The primary outcome was the incidence of LARS and secondary outcome was severity (minor versus major). Results: LARS questionnaires were received from 132/155 (85%) eligible patients. The median time from surgery to LARS assessment was 1065 days (range 174-1655 d). The incidence of LARS was 82.6% (n = 109/132), which was minor in 26/132 (19.7%) and major in 83/132 (62.9%). The most common symptoms were incontinence to flatus (n = 86/132; 65.2%) and defaecatory clustering (88/132; 66.7%). In a multivariate model, predictors of major LARS were: 1 cm decrease in tumor height above the anal verge (OR = 1.290, 95% CI: 1.101,1.511); and an ASA grade greater than 1 (OR = 2.920, 95% CI: 1.239, 6.883). Treatment allocation (laparoscopic vs robotic) did not predict major LARS. Conclusions: LARS is a common after rectal cancer surgery and patients should be appropriately counselled preoperatively, particularly before surgery for low tumors or in comorbid populations.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Cross-Sectional Studies ; Female ; Humans ; Incidence ; Laparoscopy ; Male ; Middle Aged ; Postoperative Complications/epidemiology ; Rectal Neoplasms/surgery ; Risk Factors ; Robotic Surgical Procedures ; Surveys and Questionnaires ; Syndrome
Language	English
Publishing date	2020-02-19
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	340-2
ISSN	1528-1140 ; 0003-4932
ISSN (online)	1528-1140
ISSN	0003-4932
DOI	10.1097/SLA.0000000000003806
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Article ; Online: Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection.

Corrigan, Neil / Marshall, Helen / Croft, Julie / Copeland, Joanne / Jayne, David / Brown, Julia

Trials

2018 Volume 19, Issue 1, Page(s) 339

Abstract: Background: Commonly in surgical randomised controlled trials (RCT) the experimental treatment is a relatively new technique which the surgeons may still be learning, while the control is a well-established standard. This can lead to biased comparisons ... ...

Abstract	Background: Commonly in surgical randomised controlled trials (RCT) the experimental treatment is a relatively new technique which the surgeons may still be learning, while the control is a well-established standard. This can lead to biased comparisons between treatments. In this paper we discuss the implementation of approaches for addressing this issue in the ROLARR trial, and points of consideration for future surgical trials. Methods: ROLARR was an international, randomised, parallel-group trial comparing robotic vs. laparoscopic surgery for the curative treatment of rectal cancer. The primary endpoint was conversion to open surgery (binary). A surgeon inclusion criterion mandating a minimum level of experience in each technique was incorporated. Additionally, surgeon self-reported data were collected periodically throughout the trial to capture the level of experience of every participating surgeon. Multi-level logistic regression adjusting for operating surgeon as a random effect is used to estimate the odds ratio for conversion to open surgery between the treatment groups. We present and contrast the results from the primary analysis, which did not account for learning effects, and a sensitivity analysis which did. Results: The primary analysis yields an estimated odds ratio (robotic/laparoscopic) of 0.614 (95% CI 0.311, 1.211; p = 0.16), providing insufficient evidence to conclude superiority of robotic surgery compared to laparoscopic in terms of the risk of conversion to open. The sensitivity analysis reveals that while participating surgeons in ROLARR were expert at laparoscopic surgery, some, if not all, were still learning robotic surgery. The treatment-effect odds ratio decreases by a factor of 0.341 (95% CI 0.121, 0.960; p = 0.042) per unit increase in log-number of previous robotic operations performed by the operating surgeon. The odds ratio for a patient whose operating surgeon has the mean experience level in ROLARR - 152.46 previous laparoscopic, 67.93 previous robotic operations - is 0.40 (95% CI 0.168, 0.953; p = 0.039). Conclusions: In this paper we have demonstrated the implementation of approaches for accounting for learning in a practical example of a surgery RCT analysis. The results demonstrate the value of implementing such approaches, since we have shown that without them the ROLARR analysis would indeed have been confounded by the learning effects. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) registry, ID: ISRCTN80500123. Registered on 27 May 2010.
MeSH term(s)	Clinical Competence ; Conversion to Open Surgery ; Digestive System Surgical Procedures/adverse effects ; Digestive System Surgical Procedures/methods ; Female ; Humans ; Laparoscopy/adverse effects ; Learning Curve ; Male ; Postoperative Complications/etiology ; Rectal Neoplasms/pathology ; Rectal Neoplasms/surgery ; Risk Factors ; Robotic Surgical Procedures/adverse effects ; Time Factors ; Treatment Outcome
Language	English
Publishing date	2018-06-27
Publishing country	England
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-018-2726-0
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Article ; Online: Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial.

Tassinari, Cerys Joyce / Higham, Ruchi / Smith, Isabelle Louise / Arnold, Susanne / Mujica-Mota, Ruben / Metcalfe, Andrew / Simpson, Hamish / Murray, David / McGonagle, Dennis G / Sharma, Hemant / Hamilton, Thomas William / Ellard, David R / Fernandez, Catherine / Reynolds, Catherine / Harwood, Paul / Croft, Julie / Stocken, Deborah D / Pandit, Hemant

BMJ open

2022 Volume 12, Issue 6, Page(s) e062721

Abstract: Introduction: Knee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated ...

Abstract	Introduction: Knee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated with higher mortality and inferior outcomes. With more young people presenting with knee OA and increasing life expectancy, there is an unmet need to postpone time to first KR. Knee joint distraction (KJD), the practice of using external fixators to open up knee joint space, is proposed as potentially effective to preserve the joint following initial studies in the Netherlands, however, has not been researched within an NHS setting. The KARDS trial will investigate whether KJD is non-inferior to KR in terms of patient-reported postoperative pain 12 months post-surgery. Methods and analysis: KARDS is a phase III, multicentre, pragmatic, open-label, individually randomised controlled non-inferiority trial comparing KJD with KR in patients with severe knee OA, employing a hybrid-expertise design, with internal pilot phase and process evaluation. 344 participants will be randomised (1:1) to KJD or KR. The primary outcome measure is the Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain domain score at 12 months post-operation. Secondary outcome measures include patient-reported overall KOOS, Pain Visual Analogue Scale and Oxford Knee Scores, knee function assessments, joint space width, complications and further interventions over 24 months post-operation. Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling. Ethics and dissemination: Ethics approval was obtained from the Research Ethics Committee (REC) and Health Research Authority (HRA). Trial results will be disseminated at clinical conferences, through relevant patient groups and published in peer-reviewed journals. Trial registration number: ISRCTN14879004; recruitment opened April 2021.
MeSH term(s)	Adolescent ; Arthroplasty, Replacement, Knee/methods ; Clinical Trials, Phase III as Topic ; Cost-Benefit Analysis ; Humans ; Knee Joint/surgery ; Multicenter Studies as Topic ; Osteoarthritis, Knee/surgery ; Pain, Postoperative ; Quality of Life ; Randomized Controlled Trials as Topic ; Treatment Outcome
Language	English
Publishing date	2022-06-30
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-062721
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Article ; Online: Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT.

Thomson, Simon / Ainsworth, Gemma / Selvanathan, Senthil / Kelly, Rachel / Collier, Howard / Mujica-Mota, Ruben / Talbot, Rebecca / Brown, Sarah Tess / Croft, Julie / Rousseau, Nikki / Higham, Ruchi / Al-Tamimi, Yahia / Buxton, Neil / Carleton-Bland, Nicholas / Gledhill, Martin / Halstead, Victoria / Hutchinson, Peter / Meacock, James / Mukerji, Nitin /

Pal, Debasish / Vargas-Palacios, Armando / Prasad, Anantharaju / Wilby, Martin / Stocken, Deborah

Health technology assessment (Winchester, England)

2023 Volume 27, Issue 21, Page(s) 1–228

Abstract: Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking.: Objective: The primary objective was ... ...

Abstract	Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking. Objective: The primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome. Design: This was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals. Setting: National Health Service trusts. Participants: Patients with symptomatic unilateral cervical brachialgia for at least 6 weeks. Interventions: Participants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data. Main outcome measures: The primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow-Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation. Results: The target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0-62.0 weeks) and 25.3 weeks (interquartile range 20.0-42.0 weeks), respectively, in the posterior cervical foraminotomy group ( Conclusions: The data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required. Trial registration: This trial is registered as ISRCTN10133661. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in
MeSH term(s)	Humans ; Foraminotomy ; State Medicine ; Neck Pain ; Prospective Studies ; Diskectomy ; Cost-Benefit Analysis ; Quality of Life
Language	English
Publishing date	2023-11-06
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/OTOH7720
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Article ; Online: Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT.

Jayne, David G / Williams, Annabelle E / Corrigan, Neil / Croft, Julie / Pullan, Alison / Napp, Vicky / Kelly, Rachel / Meads, David / Vargas-Palacios, Armando / Martin, Adam / Hulme, Claire / Brown, Steven R / Nugent, Karen / Lodge, Jen / Protheroe, David / Maslekar, Sushil / Clarke, Andrew / Nisar, Pasha / Brown, Julia M

Health technology assessment (Winchester, England)

2021 Volume 25, Issue 18, Page(s) 1–96

Abstract: Background: Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited.: Objective: To ...

Abstract	Background: Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited. Objective: To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness. Design, setting and participants: Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence. Interventions: Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation. Main outcome and measure: The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0-416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0-918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = -£1306 and -0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = -£3283), with only a 45% chance of FENIX being cost-effective. Limitations: The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis. Conclusions: The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group. Future work: Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness. Trial registration: Current Controlled Trials ISRCTN16077538. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
MeSH term(s)	Adult ; Cost-Benefit Analysis ; Fecal Incontinence/therapy ; Humans ; Magnetic Phenomena ; Quality of Life ; Quality-Adjusted Life Years ; Technology Assessment, Biomedical
Language	English
Publishing date	2021-02-23
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/hta25180
Database	MEDical Literature Analysis and Retrieval System OnLINE

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