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Article ; Online: Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

2024 , Page(s) 11297298241236521

Abstract: Background: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient ... ...

Abstract	Background: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that Method: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. Results: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. Conclusion: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.
Language	English
Publishing date	2024-03-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.1177/11297298241236521
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Article ; Online: Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.

BMJ open

2023 Volume 13, Issue 7, Page(s) e071646

Abstract: Introduction: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two ... ...

Abstract	Introduction: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials. Methods and analysis: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data. Ethics and dissemination: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design.
MeSH term(s)	Humans ; Renal Dialysis ; Publications ; Text Messaging ; Research Design ; Systematic Reviews as Topic
Language	English
Publishing date	2023-07-07
Publishing country	England
Document type	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-2023-071646
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Article ; Online: Recruitment into randomised trials of arteriovenous grafts: A systematic review.

The journal of vascular access

2023 , Page(s) 11297298231158413

Abstract: Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present ... ...

Abstract	Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.
Language	English
Publishing date	2023-03-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.1177/11297298231158413
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Article: The effectiveness of varicocele embolisation for the treatment of varicocele related orchalgia.

Muthuveloe, David W / During, Vinnie / Ashdown, Daniel / Rukin, Nicholas J / Jones, Rob G / Patel, Prashant

SpringerPlus

2015 Volume 4, Page(s) 392

Abstract: Purpose: Orchalgia is a common problem with varicoceles however the association between varicocele embolisation for the treatment of varicocele related pain has not been widely investigated. We aim to investigate the effectiveness of varicocele ... ...

Abstract	Purpose: Orchalgia is a common problem with varicoceles however the association between varicocele embolisation for the treatment of varicocele related pain has not been widely investigated. We aim to investigate the effectiveness of varicocele embolisation for the treatment of orchalgia secondary to varicoceles; and to see if pre-embolisation pain scores can be used to predict treatment outcomes. Methods: A prospectively collected database of patients undergoing varicocele embolisation for pain was analysed over a 10-year period. Pain scores were assessed with a 10-point visual analogue score. Analgesia requirements and satisfaction scores were assessed with questionnaires. Results: Total of 96 cases. Median age was 34 years old. Median pain scores reduced significantly following embolisation (p < 0.001). 74% had reduced pain (30% of these had resolution of pain), 24% had no change in symptoms and 1% had worsening pain. Those with moderate or severe pain had a reduction of pain in 81 and 79% of cases respectively, however 64% of cases with mild pain did not experience any benefit. We also noted a reduction in analgesia requirements and a median satisfaction score of 8/10. Conclusion: Primary varicocele embolisation can successfully reduce varicocele related orchalgia. It works best in those with moderate or severe pain. The majority of patients with mild pain may not experience any benefit so should be counseled appropriately. The classification of patients into those with mild, moderate or severe symptoms prior to embolisation should be done, so robust consenting can be performed.
Language	English
Publishing date	2015-08-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2661116-8
ISSN	2193-1801
ISSN	2193-1801
DOI	10.1186/s40064-015-1177-2
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Article: Erratum to: The effectiveness of varicocele embolisation for the treatment of varicocele related orchalgia.

Muthuveloe, David W / During, Vinnie / Ashdown, Daniel / Rukin, Nicholas J / Jones, Rob G / Patel, Prashant

SpringerPlus

2015 Volume 4, Page(s) 484

Abstract: This corrects the article DOI: 10.1186/s40064-015-1177-2.]. ...

Abstract	[This corrects the article DOI: 10.1186/s40064-015-1177-2.].
Language	English
Publishing date	2015-09-07
Publishing country	Switzerland
Document type	Published Erratum
ZDB-ID	2661116-8
ISSN	2193-1801
ISSN	2193-1801
DOI	10.1186/s40064-015-1271-5
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Article ; Online: A systematic mapping review of Randomized Controlled Trials (RCTs) in care homes

Gordon Adam L / Logan Phillipa A / Jones Rob G / Forrester-Paton Calum / Mamo Jonathan P / Gladman John RF

BMC Geriatrics, Vol 12, Iss 1, p

2012 Volume 31

Abstract: Abstract Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to ... ...

Abstract	Abstract Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs) conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years) and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies) rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated.
Keywords	Geriatrics ; RC952-954.6 ; Special situations and conditions ; RC952-1245 ; Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Internal medicine ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Subject code	360
Language	English
Publishing date	2012-06-01T00:00:00Z
Publisher	BioMed Central
Document type	Article ; Online
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Article ; Online: Six-month outcomes following an emergency hospital admission for older adults with co-morbid mental health problems indicate complexity of care needs.

Bradshaw, Lucy E / Goldberg, Sarah E / Lewis, Sarah A / Whittamore, Kathy / Gladman, John R F / Jones, Rob G / Harwood, Rowan H

Age and ageing

2013 Volume 42, Issue 5, Page(s) 582–588

Abstract: Background: two-thirds of older patients admitted as an emergency to a general hospital have co-existing mental health problems including delirium, dementia and depression. This study describes the outcomes of older adults with co-morbid mental health ... ...

Abstract	Background: two-thirds of older patients admitted as an emergency to a general hospital have co-existing mental health problems including delirium, dementia and depression. This study describes the outcomes of older adults with co-morbid mental health problems after an acute hospital admission. Methods: a follow-up study of 250 patients aged over 70 admitted to 1 of 12 wards (geriatric, medical or orthopaedic) of an English acute general hospital with a co-morbid mental health problem and followed up at 180 days. Results: twenty-seven per cent did not return to their original place of residence after the hospital admission. After 180 days 31% had died, 42% had been readmitted and 24% of community residents had moved to a care home. Only 31% survived without being readmitted or moving to a care home. However, 16% spent >170 of the 180 days at home. Significant predictors for poor outcomes were co-morbidity, nutrition, cognitive function, reduction in activities of daily living ability prior to admission, behavioural and psychiatric problems and depression. Only 42% of survivors recovered to their pre-acute illness level of function. Clinically significant behavioural and psychiatric symptoms were present at follow-up in 71% of survivors with baseline cognitive impairment, and new symptoms developed frequently in this group. Conclusions: the variable, but often adverse, outcomes in this group implies a wide range of health and social care needs. Community and acute services to meet these needs should be anticipated and provided for.
MeSH term(s)	Activities of Daily Living ; Age Factors ; Aged ; Aged, 80 and over ; Aging/psychology ; Cognition ; Comorbidity ; Delivery of Health Care, Integrated ; Emergency Service, Hospital ; England/epidemiology ; Female ; Homes for the Aged ; Hospitals, General ; Humans ; Male ; Mental Disorders/epidemiology ; Mental Disorders/mortality ; Mental Disorders/psychology ; Mental Disorders/therapy ; Mental Health ; Nursing Homes ; Patient Admission ; Patient Discharge ; Patient Readmission ; Prognosis ; Risk Factors ; Survivors/psychology ; Time Factors
Language	English
Publishing date	2013-06-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	186788-x
ISSN	1468-2834 ; 0002-0729
ISSN (online)	1468-2834
ISSN	0002-0729
DOI	10.1093/ageing/aft074
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Article ; Online: The diagnosis, prevalence and outcome of delirium in a cohort of older people with mental health problems on general hospital wards.

Whittamore, Kathy H / Goldberg, Sarah E / Gladman, John R F / Bradshaw, Lucy E / Jones, Rob G / Harwood, Rowan H

International journal of geriatric psychiatry

2013 Volume 29, Issue 1, Page(s) 32–40

Abstract: Objectives: This paper aimed to measure the prevalence and outcomes of delirium for patients over 70 admitted to a general hospital for acute medical care and to assess the validity of the Delirium Rating Scale-Revised-98 (DRS-R-98) in this setting.: ... ...

Abstract	Objectives: This paper aimed to measure the prevalence and outcomes of delirium for patients over 70 admitted to a general hospital for acute medical care and to assess the validity of the Delirium Rating Scale-Revised-98 (DRS-R-98) in this setting. Methods: Prospective study in a British acute general hospital providing sole emergency medical services for its locality. We screened consecutive patients over 70 with an unplanned emergency hospital admission and recruited a cohort of 249 patients likely to have mental health problems. They were assessed for health status at baseline and followed over 6 months. A sub-sample of 93 participants was assessed clinically for delirium. Results: 27% (95% confidence interval (CI) 23-31) of all older medical patients admitted to hospital had DRS-diagnosed delirium, and 41% (95% CI 37-45) had dementia (including 19% with co-morbid delirium and dementia). Compared with clinician diagnosis, DRS-R-98 sensitivity was at least 0.75, specificity 0.71. Compared with reversible cognitive impairment, sensitivity was at least 0.50, specificity 0.67. DRS-diagnosed delirium was associated with cognitive impairment, mood, behavioural and psychological symptoms, activities of daily living, and number of drugs prescribed, supporting construct validity. Of those with DRS-diagnosed delirium, 37% died within 6 months (relative risk 1.4, 95% CI 0.97-2.2), 43% had reversible cognitive impairment, but only 25% had clinically important recovery in activities of daily living. Behavioural and psychological symptoms were common and mostly resolved, but new symptoms frequently developed. Conclusion: Delirium is common. Some, but not all, features are reversible. DRS-R-98 has reasonable validity in populations where co-morbid dementia is prevalent.
MeSH term(s)	Aged ; Aged, 80 and over ; Cohort Studies ; Delirium/diagnosis ; Delirium/epidemiology ; Delirium/mortality ; Female ; Hospitals, General/statistics & numerical data ; Humans ; Length of Stay/statistics & numerical data ; Male ; Mental Disorders/complications ; Outcome Assessment, Health Care ; Patient Readmission/statistics & numerical data ; Prevalence ; Prospective Studies ; Psychiatric Status Rating Scales/standards ; Reproducibility of Results ; Sensitivity and Specificity ; United Kingdom/epidemiology
Language	English
Publishing date	2013-04-22
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	806736-3
ISSN	1099-1166 ; 0885-6230
ISSN (online)	1099-1166
ISSN	0885-6230
DOI	10.1002/gps.3961
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Article ; Online: A systematic mapping review of randomized controlled trials (RCTs) in care homes.

Gordon, Adam L / Logan, Phillipa A / Jones, Rob G / Forrester-Paton, Calum / Mamo, Jonathan P / Gladman, John R F

BMC geriatrics

2012 Volume 12, Page(s) 31

Abstract: Background: A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe ... ...

Abstract	Background: A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods: A systematic mapping review was conducted of the randomized controlled trials (RCTs) conducted in care homes. Medline was searched for "Nursing Home", "Residential Facilities" and "Homes for the Aged"; CINAHL for "nursing homes", "residential facilities" and "skilled nursing facilities"; AMED for "Nursing homes", "Long term care", "Residential facilities" and "Randomized controlled trial"; and BNI for "Nursing Homes", "Residential Care" and "Long-term care". Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results: 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years) and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies) rather than disease-based. Over a quarter focussed on mental health. Conclusions: This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis - are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated.
MeSH term(s)	Homes for the Aged/trends ; Humans ; Nursing Homes/trends ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/trends ; Residential Facilities/methods ; Residential Facilities/trends
Language	English
Publishing date	2012-06-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ZDB-ID	2059865-8
ISSN	1471-2318 ; 1471-2318
ISSN (online)	1471-2318
ISSN	1471-2318
DOI	10.1186/1471-2318-12-31
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Article ; Online: The prevalence of mental health problems among older adults admitted as an emergency to a general hospital.

Goldberg, Sarah E / Whittamore, Kathy H / Harwood, Rowan H / Bradshaw, Lucy E / Gladman, John R F / Jones, Rob G

Age and ageing

2011 Volume 41, Issue 1, Page(s) 80–86

Abstract: Background: A high prevalence of co-morbid mental health problems is reported among older adults admitted to general hospitals.: Setting: An 1,800 bed teaching hospital.: Design: Consecutive general medical and trauma orthopaedic admissions aged ... ...

Abstract	Background: A high prevalence of co-morbid mental health problems is reported among older adults admitted to general hospitals. Setting: An 1,800 bed teaching hospital. Design: Consecutive general medical and trauma orthopaedic admissions aged 70 or older were screened for mental health problems. Those screening positive were invited to undergo further assessment, and were interviewed to complete a battery of health status measurements. Results: Of 1,004 patients screened, 36% had no mental health problems or had anxiety alone. Of those screening positive 250 took part in the full study. Adjusting for the two-stage sampling design, 50% of admitted patients over 70 were cognitively impaired, 27% had delirium and 8-32% were depressed. Six percent had hallucinations, 8% delusions, 21% apathy and 9% agitation/aggression (of at least moderate severity). Of those with mental health problems, 47% were incontinent, 49% needed help with feeding and 44% needed major help to transfer. Interpretation: We confirm the high prevalence of mental health problems among older adults admitted to general hospitals. These patients have high levels of functional dependency, psychological and behavioural problems which have implications for how they are cared for. Services that identify these problems and offer therapeutic intervention should be evaluated.
MeSH term(s)	Aged ; Aged, 80 and over ; Anxiety/epidemiology ; Delusions/epidemiology ; Depression/epidemiology ; Emergencies/epidemiology ; Female ; Geriatric Assessment/statistics & numerical data ; Hallucinations/epidemiology ; Hospitals, General/statistics & numerical data ; Hospitals, Teaching/statistics & numerical data ; Humans ; Male ; Mental Disorders/epidemiology ; Patient Admission/statistics & numerical data ; Prevalence ; United Kingdom/epidemiology
Language	English
Publishing date	2011-09-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	186788-x
ISSN	1468-2834 ; 0002-0729
ISSN (online)	1468-2834
ISSN	0002-0729
DOI	10.1093/ageing/afr106
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