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

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 quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. 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.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.

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.

Recruitment into randomised trials of arteriovenous grafts: A systematic review.

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.

Erratum to: The effectiveness of varicocele embolisation for the treatment of varicocele related orchalgia.

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

The effectiveness of varicocele embolisation for the treatment of varicocele related orchalgia.

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.

The diagnosis, prevalence and outcome of delirium in a cohort of older people with mental health problems on general hospital wards.

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.

Care in specialist medical and mental health unit compared with standard care for older people with cognitive impairment admitted to general hospital: randomised controlled trial (NIHR TEAM trial).

OBJECTIVE: To develop and evaluate a best practice model of general hospital acute medical care for older people with cognitive impairment. DESIGN: Randomised controlled trial, adapted to take account of constraints imposed by a busy acute medical admission system. SETTING: Large acute general hospital in the United Kingdom. PARTICIPANTS: 600 patients aged over 65 admitted for acute medical care, identified as "confused" on admission. INTERVENTIONS: Participants were randomised to a specialist medical and mental health unit, designed to deliver best practice care for people with delirium or dementia, or to standard care (acute geriatric or general medical wards). Features of the specialist unit included joint staffing by medical and mental health professionals; enhanced staff training in delirium, dementia, and person centred dementia care; provision of organised purposeful activity; environmental modification to meet the needs of those with cognitive impairment; delirium prevention; and a proactive and inclusive approach to family carers. PRIMARY OUTCOME: number of days spent at home over the 90 days after randomisation. SECONDARY OUTCOMES: structured non-participant observations to ascertain patients' experiences; satisfaction of family carers with hospital care. When possible, outcome assessment was blind to allocation. RESULTS: There was no significant difference in days spent at home between the specialist unit and standard care groups (median 51 v 45 days, 95% confidence interval for difference -12 to 24; P=0.3). Median index hospital stay was 11 versus 11 days, mortality 22% versus 25% (-9% to 4%), readmission 32% versus 35% (-10% to 5%), and new admission to care home 20% versus 28% (-16% to 0) for the specialist unit and standard care groups, respectively. Patients returning home spent a median of 70.5 versus 71.0 days at home (-6.0 to 6.5). Patients on the specialist unit spent significantly more time with positive mood or engagement (79% v 68%, 2% to 20%; P=0.03) and experienced more staff interactions that met emotional and psychological needs (median 4 v 1 per observation; P<0.001). More family carers were satisfied with care (overall 91% v 83%, 2% to 15%; P=0.004), and severe dissatisfaction was reduced (5% v 10%, -10% to 0%; P=0.05). CONCLUSIONS: Specialist care for people with delirium and dementia improved the experience of patients and satisfaction of carers, but there were no convincing benefits in health status or service use. Patients' experience and carers' satisfaction might be more appropriate measures of success for frail older people approaching the end of life. TRIAL REGISTRATION: Clinical Trials NCT01136148.

Six-month outcomes following an emergency hospital admission for older adults with co-morbid mental health problems indicate complexity of care needs.

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.

A systematic mapping review of randomized controlled trials (RCTs) in care homes.

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.

The prevalence of mental health problems among older adults admitted as an emergency to a general hospital.

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.

Evaluation of a Medical and Mental Health Unit compared with standard care for older people whose emergency admission to an acute general hospital is complicated by concurrent 'confusion': a controlled clinical trial. Acronym: TEAM: Trial of an Elderly Acute care Medical and mental health unit.

BACKGROUND: Patients with delirium and dementia admitted to general hospitals have poor outcomes, and their carers report poor experiences. We developed an acute geriatric medical ward into a specialist Medical and Mental Health Unit over an eighteen month period. Additional specialist mental health staff were employed, other staff were trained in the 'person-centred' dementia care approach, a programme of meaningful activity was devised, the environment adapted to the needs of people with cognitive impairment, and attention given to communication with family carers. We hypothesise that patients managed on this ward will have better outcomes than those receiving standard care, and that such care will be cost-effective. METHODS/DESIGN: We will perform a controlled clinical trial comparing in-patient management on a specialist Medical and Mental Health Unit with standard care. Study participants are patients over the age of 65, admitted as an emergency to a single general hospital, and identified on the Acute Medical Admissions Unit as being 'confused'. Sample size is 300 per group. The evaluation design has been adapted to accommodate pressures on bed management and patient flows. If beds are available on the specialist Unit, the clinical service allocates patients at random between the Unit and standard care on general or geriatric medical wards. Once admitted, randomised patients and their carers are invited to take part in a follow up study, and baseline data are collected. Quality of care and patient experience are assessed in a non-participant observer study. Outcomes are ascertained at a follow up home visit 90 days after randomisation, by a researcher blind to allocation. The primary outcome is days spent at home (for those admitted from home), or days spent in the same care home (if admitted from a care home). Secondary outcomes include mortality, institutionalisation, resource use, and scaled outcome measures, including quality of life, cognitive function, disability, behavioural and psychological symptoms, carer strain and carer satisfaction with hospital care. Analyses will comprise comparisons of process, outcomes and costs between the specialist unit and standard care treatment groups. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01136148.