Commentary on: Garcez FB, Apolinario D, Campora F et al. Delirium and post-discharge dementia: results from a cohort of older adults without baseline cognitive impairment. Age Ageing 2019;48:845–51.
As many as one in three older people who experience delirium in a hospital setting may go on to develop dementia. Delirium is associated with longer term cognitive impairment but there has been limited research or evidence about its impact on older people. Future research on dementia prevention should consider delirium as a modifiable risk factor.
As many as one in three older people who experience delirium in a hospital setting may go on to develop dementia.
Delirium is associated with longer term cognitive impairment but there has been limited research or evidence about its impact on older people.
Future research on dementia prevention should consider delirium as a modifiable risk factor.
Delirium is a disorder that is characterised by a rapid deterioration of mental function triggered by a medical disorder or environmental change.
To predict the cost and health effects of routine use of whole-genome sequencing (WGS) of bacterial pathogens compared with those of standard of care.
Budget impact analysis was performed over the following 5 years. Data were primarily from sequencing results on clusters of multidrug-resistant organisms across 27 hospitals. Model inputs were derived from hospitalisation and sequencing data, and epidemiological and costing reports, and included multidrug resistance rates and their trends.
WGS surveillance of six common multidrug-resistant organisms (Staphylococcus aureus, Escherichia coli, Enterococcus faecium, Klebsiella pneumoniae, Enterobacter sp and Acinetobacter baumannii) compared with standard of care or routine microbiology testing.
Expected hospital costs, counts of patient infections and colonisations, and deaths from bloodstream infections.
In 2021, 97 539 patients in Queensland are expected to be infected or colonised with one of six multidrug-resistant organisms with standard of care testing. WGS surveillance strategy and earlier infection control measures could avoid 36 726 infected or colonised patients and avoid 650 deaths. The total cost under standard of care was $A170.8 million in 2021. WGS surveillance costs an additional $A26.8 million but was offset by fewer costs for cleaning, nursing, personal protective equipment, shorter hospital stays and antimicrobials to produce an overall cost savings of $30.9 million in 2021. Sensitivity analyses showed cost savings remained when input values were varied at 95% confidence limits.
Compared with standard of care, WGS surveillance at a state-wide level could prevent a substantial number of hospital patients infected with multidrug-resistant organisms and related deaths and save healthcare costs. Primary prevention through routine use of WGS is an investment priority for the control of serious hospital-associated infections.
Since the outbreak of COVID‐19 pandemic, clinicians have had to use personal protective equipment (PPE) for prolonged periods. This has been associated with detrimental effects, especially in relation to the skin health. The present study describes a comprehensive survey of healthcare workers (HCWs) to describe their experiences using PPE in managing COVID‐19 patients, with a particular focus on adverse skin reactions. A 24‐hour prevalence study and multi‐centre prospective survey were designed to capture the impact of PPE on skin health of hospital staff. Questionnaires incorporated demographics of participants, PPE type, usage time, and removal frequency. Participants reported the nature and location of any corresponding adverse skin reactions. The prevalence study included all staff in intensive care from a single centre, while the prospective study used a convenience sample of staff from three acute care providers in the United Kingdom. A total of 108 staff were recruited into the prevalence study, while 307 HCWs from a variety of professional backgrounds and demographics participated in the prospective study. Various skin adverse reactions were reported for the prevalence study, with the bridge of the nose (69%) and ears (30%) being the most affected. Of the six adverse skin reactions recorded for the prospective study, the most common were redness blanching (33%), itchiness (22%), and pressure damage (12%). These occurred predominantly at the bridge of the nose and the ears. There were significant associations (P < .05) between the adverse skin reactions with both the average daily time of PPE usage and the frequency of PPE relief. The comprehensive study revealed that the use of PPE leads to an array of skin reactions at various facial locations of HCWs. Improvements in guidelines are required for PPE usage to protect skin health. In addition, modifications to PPE designs are required to accommodate a range of face shapes and appropriate materials to improve device safety.
Commentary on: Zhang W, Low LF, Gwynn JD, et al. Interventions to improve gait in older adults with cognitive impairment: a systematic review. J Am Geriatr Soc 2019;67;381–91.
Gait is not solely a biomechanical process. Cognitive factors need to be considered when employing interventions to improve gait in older people. Physical and cognitive factors affect gait performance, and both should be addressed in intervention programs. To improve gait in older people living with mild cognitive impairment, or the early stages of dementia, gait interventions should include strength, balance and functional mobility training in combination with cognitive control training.
Gait is not solely a biomechanical process. Cognitive factors need to be considered when employing interventions to improve gait in older people.
Physical and cognitive factors affect gait performance, and both should be addressed in intervention programs.
To improve gait in older people living with mild cognitive impairment, or the early stages of dementia, gait interventions should include strength, balance and functional mobility training in combination with cognitive control training.
The prevalence of gait and balance disorders significantly increases as a person grows older. These disorders affect around 10% people in their 60s and >60% of people in their 80s.
by Dawn M. Dudley, Christina M. Newman, Andrea M. Weiler, Mitchell D. Ramuta, Cecilia G. Shortreed, Anna S. Heffron, Molly A. Accola, William M. Rehrauer, Thomas C. Friedrich, David H. O’ConnorSARS-CoV-2 testing is crucial to controlling the spread of this virus, yet shortages of nucleic acid extraction supplies and other key reagents have hindered the response to COVID-19 in the US. Several groups have described loop-mediated isothermal amplification (LAMP) assays for SARS-CoV-2, including testing directly from nasopharyngeal swabs and eliminating the need for reagents in short supply. Frequent surveillance of individuals attending work or school is currently unavailable to most people but will likely be necessary to reduce the ~50% of transmission that occurs when individuals are nonsymptomatic. Here we describe a fluorescence-based RT-LAMP test using direct nasopharyngeal swab samples and show consistent detection in clinically confirmed primary samples with a limit of detection (LOD) of ~625 copies/μl, approximately 100-fold lower sensitivity than qRT-PCR. While less sensitive than extraction-based molecular methods, RT-LAMP without RNA extraction is fast and inexpensive. Here we also demonstrate that adding a lysis buffer directly into the RT-LAMP reaction improves the sensitivity of some samples by approximately 10-fold. Furthermore, purified RNA in this assay achieves a similar LOD to qRT-PCR. These results indicate that high-throughput RT-LAMP testing could augment qRT-PCR in SARS-CoV-2 surveillance programs, especially while the availability of qRT-PCR testing and RNA extraction reagents is constrained.
A novel coronavirus SARS-CoV-2 has been responsible for a worldwide pandemic. Children typically have very mild, or no, symptoms of infection. This makes estimations of seroprevalence in children difficult. Research is therefore required to determine the seroprevalence of SARS-CoV-2 antibodies in children. The primary objective of this study is to report the seroprevalence of SARS-CoV-2 IgM and/or IgG antibodies in healthy children at baseline, 2 months and 6 months. This is the only longitudinal UK study of seroprevalence in an exclusively paediatric population. Determining the changing seroprevalence is of vital public health importance and can help inform decisions around the lifting of paediatric specific social distancing measures such as school closures and the cancellation of routine paediatric hospital services.
1000 healthy children of healthcare workers aged between 2 and 15 years will be recruited from five UK sites (Belfast, Cardiff, Glasgow, London and Manchester). The children will undergo phlebotomy at baseline, 2 months and 6 months to measure IgM and/or IgG positivity to SARS-CoV-2. A sample size of 675 patients is required to detect a 5% change in seroprevalence at each time point assuming an alpha of 0.05 and a beta of 0.2. Adjusted probabilities for the presence of IgG and/or IgM antibodies and of SARS-CoV-2 infection will be reported using logistic regression models where appropriate.
Ethical approval was obtained from the London - Chelsea Research Ethics Committee (REC Reference—20/HRA/1731) and the Belfast Health & Social Care Trust Research Governance (Reference 19147TW-SW). Results of this study will be made available as preprints and submitted for publication in peer-reviewed journals.
To examine the efficacy of an immersive virtual reality distraction compared with an active non‐immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.
Three‐centre randomized clinical trial using a parallel design with two groups: experimental and control.
Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7–17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self‐reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%.
While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting.
Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non‐pharmacological, adapted to the hospital setting, and user‐friendly.
NCT03680625, registered on clinicaltrials.gov.
To determine whether a collaborative model of care that uses task-sharing for the management of low-risk diabetic retinopathy, Community Eye Care (C-EYE-C), can improve access to care and better use resources, compared with hospital-based care.
Retrospective audit of medical and financial records to compare two models of care.
A large, urban tertiary Australian publicly funded hospital.
C-EYE-C is a collaborative care model, involving community-based optometrist assessment and ‘virtual review’ by ophthalmologists to manage low-risk patients. The C-EYE-C model of care was implemented from January to October 2017.
New low-risk patient referrals with diabetes received at a tertiary hospital ophthalmology unit.
Historical standard hospital care was compared with C-EYE-C for attendance, wait-times, outcomes and costs. Clinical concordance between the optometrist and ophthalmologist diagnosis and management was assessed using weighted kappa statistic.
There were 133 new low-risk referrals, managed in standard hospital care (n=68) and C-EYE-C (n=65). Attendance rates were similar between the models of care (72.1% hospital vs 67.7% C-EYE-C, p=0.71). C-EYE-C had shorter appointment wait-time (53 vs 118 days, p
This Australian study showed that collaborative eye care resulted in reduced patient waiting times and considerable cost-savings, while maintaining a high standard of patient care compared with traditional hospital-based care in the management of low-risk hospital referrals with diabetic eye disease. The improved access and reduced costs were largely the result of better task allocation through greater utilisation of primary eye care professionals to provide services for low-risk patients. Better resource use may free up further resources for other eye care services.
Fear of hypoglycaemia (FoH) has been associated with suboptimal diabetes management and health outcomes. This study investigated factors associated with behavioural and emotional aspects of FoH among adults living with type 1 diabetes (T1D) mellitus.
Online survey hosted on T1D Exchange Glu, an online community for patients living with T1D mellitus.
The Hypoglycaemia Fear Survey II-short form and the Hypoglycaemic Attitudes and Behaviour Scale were used to assess FoH. Multivariable regressions were performed on assessment scores.
The study included 494 participants (mean±SD age 43.9±12.2 years, duration of T1D mellitus 16.6±16.8 years, self-reported glycosylated hemoglobin (HbA1c) 6.9%±0.8% (52±9 mmol/mol)), 63% men, 89% on insulin pump, 25% experienced a severe hypoglycaemic event in the last 6 months. Multivariable regression analyses showed higher anxiety, depression severity and diabetes distress were independently associated with FoH (all p
These results highlighted the multifaceted nature of FoH, which warrants further discussion between providers and patients to uncover drivers of and actions required to reduce FoH and improve patient care and outcomes.
Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent–child interactions to improve early social reciprocity, while supporting parental mental health and the parent–child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent–infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.
This protocol has been approved by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.
Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).
Previous qualitative research investigating the experiences of women diagnosed with gestational diabetes (GD) has provided important insights into the development of behaviour change interventions. However, these studies often lack a theoretical underpinning. This study explored the use of the capability, opportunity, motivation and behaviour (COM-B) framework (which proposes that individuals need the capability, opportunity and motivation to perform a particular behaviour) to code and the socioecological model to contextualise participant responses to better inform intervention development.
Qualitative semistructured interviews are using purposive sampling. Interviews were audio-recorded, transcribed and coded using the COM-B framework. A socioecological approach was adopted to understand the context of intervention facets.
Interviews were conducted in a secondary care setting in South Yorkshire.
Twenty-seven postnatal women with a previous diagnosis of GD were interviewed.
Applying the COM-B framework to code participant, responses identified 16 key subthemes which reflected either: capability, opportunity or motivation components of the model. Four domains adapted from the socioecological model: individual, family life, community and healthcare provision; contextualised factors are important for these women in terms of behaviour change. Emotional response at the individual level was highly motivating or demotivating. Factors related to family life and community were particularly dominant and had the potential to either facilitate or impede change. We found many participants relied on healthcare provision during the prenatal and postnatal periods with timing and positive relationships being key to good care.
Our study provides further insight into the factors crucial for behaviour change in women diagnosed with GD. By innovatively applying the COM-B framework in a socioecological context, it is clear intervention facets need to target microlevel through the macrolevel to engage this population in behaviour change. Future work should consider family-level intervention as this could allow for sustained behaviour change and consequently prevent the development of type 2 diabetes mellitus.
The aim of this study was to explore nurse navigators and consumers’ experience of partnership.
The nurse navigator has recently emerged as an advanced practice role in the care of persons with complex and chronic disease states. Self‐care is an important principle in chronic disease models of care, requiring healthcare practitioners to partner with clients in their care. How nurse navigators and consumers [clients and family] experience partnership has not been explored.
An interpretive exploratory qualitative approach was used. Semi‐structured interviews were conducted with seven nurse navigators working with adults with complex disease states and eleven of their clients. Interviews were analysed using descriptive content analysis. (COREQ checklist Data #jocn15364-sup-0001S1).
Five themes about partnership emerged. Three themes from nurse navigators were as follows: establishing and sustaining relationships, nurse‐led planning and aligning care with clients’ needs. The two consumer themes were as follows: regular contact means access to the health system and nurse presence is valued. The secondary analysis revealed two themes about partnership between the nurse and consumer: establishing relationships require nursing effort to be established and partnerships are person‐focused and nurse‐led.
Partnership begins with a relationship, largely driven by the nurse navigator through regular communication and personal contact that was valued by consumers. The nurse‐led partnership reduced opportunities for consumers to learn to manage their treatments, particularly how and when to access services, meaning that self‐care may not be fully achieved. Client navigation occurs over long periods, which could lead to the navigators being overwhelmed, raising an issue of sustainability.
Nurse navigators establish a client relationship as a foundation for partnership. This partnership needs a focus on promoting client self‐care, self‐management of treatment, including when and how to access available services, to ensure the sustainability of the nurse navigator model of care.
Agricultural workers working in high ambient temperatures are at risk for acute kidney injury. Despite recommendations to maintain hydration, workers likely do not drink enough to protect their renal function. Additionally, new research suggests that rehydration with sugary beverages adds additional risk to kidneys already stressed by high heat and workload. We assessed hydration choices during a work shift and tested associations of rehydration using sugary beverages with acute kidney injury.
We recruited a convenience sample of workers on farms over two summers. We estimated acute kidney injury via pre‐ and post‐shift serum creatinine readings from capillary blood samples. We used self‐reported measures of the volume and type of fluids workers consumed during their shifts. We also measured changes in core body temperature, ambient temperature, and workload. We used logistic regression to estimate associations of sugary drinks with acute kidney injury, while controlling for physiologic and occupational variables.
In our sample of 445 participants, we found that men drink more than women do overall, including more than a liter of water than women (2.9 L compared to 1.9 L, respectively). The total volume workers drank was associated with increased odds of acute kidney injury (adjusted odds ratio 1.47, 95% confidence interval 1.09–1.99). We found no association of sugary drinks with acute kidney injury.
These findings provide important information about what men and women use to hydrate during the work day and suggest that they do not drink enough to maintain adequate hydration. Increased fluid intake during the work day may be a result of vigorous workload, which could explain the increased risk for acute kidney injury. Nurses play an important role in educating agricultural workers about the importance of maintaining hydration at work.
This study advances current knowledge of occupational risk factors for acute kidney injury in agricultural workers. Nurses may be the only point of care for this vulnerable population and are therefore in a unique position to educate on the importance of proper hydration during work.
by Robin S. Cronin, Jessica Wilson, Adrienne Gordon, Minglan Li, Vicki M. Culling, Camille H. Raynes-Greenow, Alexander E. P. Heazell, Tomasina Stacey, Lisa M. Askie, Edwin A. Mitchell, John M. D. Thompson, Lesley M. E. McCowan, Louise M. O’BrienBackground and objectives
Sleep-disordered breathing (SDB) affects up to one third of women during late pregnancy and is associated with adverse pregnancy outcomes, including hypertension, diabetes, impaired fetal growth, and preterm birth. However, it is unclear if SDB is associated with late stillbirth (≥28 weeks’ gestation). The aim of this study was to investigate the relationship between self-reported symptoms of SDB and late stillbirth.Methods
Data were obtained from five case-control studies (cases 851, controls 2257) from New Zealand (2 studies), Australia, the United Kingdom, and an international study. This was a secondary analysis of an individual participant data meta-analysis that investigated maternal going-to-sleep position and late stillbirth, with a one-stage approach stratified by study and site. Inclusion criteria: singleton, non-anomalous pregnancy, ≥28 weeks’ gestation. Sleep data (‘any’ snoring, habitual snoring ≥3 nights per week, the Berlin Questionnaire [BQ], sleep quality, sleep duration, restless sleep, daytime sleepiness, and daytime naps) were collected by self-report for the month before stillbirth. Multivariable analysis adjusted for known major risk factors for stillbirth, including maternal age, body mass index (BMI kg/m2), ethnicity, parity, education, marital status, pre-existing hypertension and diabetes, smoking, recreational drug use, baby birthweight centile, fetal movement, supine going-to-sleep position, getting up to use the toilet, measures of SDB and maternal sleep patterns significant in univariable analysis (habitual snoring, the BQ, sleep duration, restless sleep, and daytime naps). Registration number: PROSPERO, CRD42017047703.Results
In the last month, a positive BQ (adjusted odds ratio [aOR] 1.44, 95% confidence interval [CI] 1.02–2.04), sleep duration >9 hours (aOR 1.82, 95% CI 1.14–2.90), daily daytime naps (aOR 1.52, 95% CI 1.02–2.28) and restless sleep greater than average (aOR 0.62, 95% CI 0.44–0.88) were independently related to the odds of late stillbirth. ‘Any’ snoring, habitual snoring, sleep quality, daytime sleepiness, and a positive BQ excluding the BMI criterion, were not associated.Conclusion
A positive BQ, long sleep duration >9 hours, and daily daytime naps last month were associated with increased odds of late stillbirth, while sleep that is more restless than average was associated with reduced odds. Pregnant women may be reassured that the commonly reported restless sleep of late pregnancy may be physiological and associated with a reduced risk of late stillbirth.
Commentary on: Lange P, Lamanna M, Watson R, et al. Undiagnosed delirium is frequent and difficult to predict: results from a prevalence survey of a tertiary hospital. JClin Nurs 2019; 28; 2537–42.
Delirium is common but it is frequently undiagnosed within hospital settings internationally. Older age and dementia are the strongest predictive factors associated with undiagnosed delirium. Validated assessment of all hospitalised patients for delirium is recommended to improve delirium diagnosis among hospitalised patients.
Delirium is common but it is frequently undiagnosed within hospital settings internationally.
Older age and dementia are the strongest predictive factors associated with undiagnosed delirium.
Validated assessment of all hospitalised patients for delirium is recommended to improve delirium diagnosis among hospitalised patients.
Previous research on delirium prevalence in hospital settings suggests it is a common condition which can affect around 20% of older people.
Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.
The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.
The study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.
To describe the clinimetric validation of the I-DECIDED tool for peripheral intravenous catheter assessment and decision-making.
I-DECIDED is an eight-step tool derived from international vascular access guidelines into a structured mnemonic for device assessment and decision-making. The clinimetric evaluation process was conducted in three distinct phases.
Initial face validity was confirmed with a vascular access working group. Next, content validity testing was conducted via online survey with vascular access experts and clinicians from Australia, the UK, the USA and Canada. Finally, inter-rater reliability was conducted between 34 pairs of assessors for a total of 68 peripheral intravenous catheter (PIVC) assessments. Assessments were timed to ensure feasibility, and the second rater was blinded to the first’s findings. Content validity index (CVI), mean item-level CVI (I-CVI), internal consistency, mean proportion of agreement, observed and expected inter-rater agreements, and prevalence-adjusted bias-adjusted kappas (PABAK) were calculated. Ethics approvals were obtained from university and hospital ethics committees.
The I-DECIDED tool demonstrated strong content validity among international vascular access experts (n=7; mean I-CVI=0.91; mean proportion of agreement=0.91) and clinicians (n=11; mean I-CVI=0.93; mean proportion of agreement=0.94), and high inter-rater reliability in seven adult medical-surgical wards of three Australian hospitals. Overall, inter-rater reliability was 87.13%, with PABAK for each principle ranging from 0.5882 (‘patient education’) to 1.0000 (‘document the decision’). Time to complete assessments averaged 2 min, and nurse-reported acceptability was high.
This is the first comprehensive, evidence-based, valid and reliable PIVC assessment and decision tool. We recommend studies to evaluate the outcome of implementing this tool in clinical practice.
The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.
This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.
Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.
Methotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.
Double-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.
11 palliative care sites in Australia.
Participants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.
Based on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.
A ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.
Response to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In the per protocol analysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Complete per protocol response rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.
This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.
Closed incision negative pressure wound therapy (CINPWT) has been shown to be clinically effective compared with the traditional gauze dressing, reducing surgical site infections and wound complications. We evaluated the effect of CINPWT compared with gauze dressing on the need for revision surgery and survival after non‐traumatic major lower amputation. We included 309 patients undergoing 403 major lower amputations in a retrospective study from January 1, 2010 to November 23, 2017. A total of 139 patients received CINPWT, and 170 patients received stump bandage. There was no statistically significant difference between the two groups regarding the need for revision surgery (P = .45). Fourteen stump bandage patients and 15 CINPWT patients died in hospital (P = .57). One year after amputation, 55 CINPWT patients and 66 stump bandage patients had died (P = .82). Survival probabilities adjusted for age and gender 2 years after amputation were .52 (.43‐.61) and .49 (.42‐.58), respectively, and 3 years after amputation were .36 (.25‐.50) and .39 (.32‐.47), respectively. We also found no significant difference in the need for revision surgery in survival probabilities up till 3 years after amputation between patients treated with CINPWT and patients treated with gauze bandage postoperatively.