Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable. This is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, poor healthcare infrastructure and fear of death. Where patients are confused or unconscious the responsibility for this decision falls to relatives. This qualitative study is nested in the ongoing AMBIsome Therapy Induction OptimisatioN (AMBITION) Trial. AMBITION is recruiting participants from five countries in sub-Saharan Africa and is trialling a novel treatment approach for HIV-associated cryptococcal meningitis, an infection known to affect brain function. We aim to learn from the experiences of participants, relatives and researchers involved in AMBITION.
We will collect data through in-depth interviews with trial participants and the next of kin of participants who were confused at enrolment and therefore provided surrogate consent. Data will be collected in Gaborone, Botswana; Kampala, Uganda and Harare, Zimbabwe. Interviews will follow a narrative approach including participatory drawing of participation timelines. This will be supplemented by direct observation of the research process at each of the three recruiting hospitals. Interviews will also take place with researchers from the African and European institutions that form the partnership through which the trial is administered. Interviews will be transcribed verbatim, translated (if necessary) and organised thematically for narrative analysis.
This study has been approved by the Health Research Development Committee, Gaborone (Reference: HPDME:13/18/1); Makerere School of Health Sciences Institutional Review Board, Kampala (Reference: 2019–061); University of Zimbabwe Joint Research Ethics Committee, Harare (Reference: 219/19), and the London School of Hygiene and Tropical Medicine (Reference: 17957). Study findings will be shared with research participants from the sites, key stakeholders at each research institution and ministries of health to help inform the development and implementation of future trials. The findings of this study will be published in journals and presented at academic meetings.
Registered at www.clinicaltrials.gov:
Commentary on: Keeble, E, Parker, SG, Arora, S, et al. Frailty, hospital use and mortality in the older population: findings from the Newcastle 85+ study. Age Ageing 2019;48:797–802. https://doi.org/10.1093/ageing/afz094.
Frailty leads to higher mortality and hospital use. Information about frailty should inform the development of services to meet patient need. Research in the community setting is required to better understand proactive and preventative approaches in frailty management.
Frailty leads to higher mortality and hospital use.
Information about frailty should inform the development of services to meet patient need.
Research in the community setting is required to better understand proactive and preventative approaches in frailty management.
Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalisation and mortality. Frailty is a significant determinant of healthcare use and associated costs, both of which also increase as a person nears death. In the UK, and internationally, those aged over 85 years are the fastest growing demographic group. By 2050, the number of people...
Commentary on: Brooker H, Wesnes KA, Ballard C, et al. An online investigation of the relationship between the frequency of word puzzle use and cognitive function in a large sample of older adults. Int J Geriatr Psychiatry 2019;34:921–31. doi: 10.1002/gps.5033.
Psychosocial approaches to enhancing and reableing cognitive function are becoming increasingly useful in the everyday practice of nurses working with people with dementia. There is a great benefit in conducting such longitudinal cohort studies, such as PROTECT (Platform for Research Online to investigate Genetics and Cognition in Ageing) and others, that allows for important subanalysis of data such as this, which add to the body of evidence in preventing or delaying dementia.
Psychosocial approaches to enhancing and reableing cognitive function are becoming increasingly useful in the everyday practice of nurses working with people with dementia.
There is a great benefit in conducting such longitudinal cohort studies, such as PROTECT (Platform for Research Online to investigate Genetics and Cognition in Ageing) and others, that allows for important subanalysis of data such as this, which add to the body of evidence in preventing or delaying dementia.
A degree of cognitive decline is common in ageing; however, it can also be a precursor to mild cognitive impairment and dementia, such as Alzheimer’s disease...
by William R. Nardi, Abigail Harrison, Frances B. Saadeh, Julie Webb, Anna E. Wentz, Eric B. LoucksBackground
Mindfulness-based programs hold promise for improving cardiovascular health (e.g. physical activity, diet, blood pressure). However, despite theoretical frameworks proposed, no studies have reported qualitative findings on how study participants themselves believe mindfulness-based programs improved their cardiovascular health. With an emphasis on in-depth, open-ended investigation, qualitative methods are well suited to explore the mechanisms underlying health outcomes. The objective of this qualitative study was to explore the mechanisms through which the mindfulness-based program, Mindfulness-Based Blood Pressure Reduction (MB-BP), may influence cardiovascular health.Methods
This qualitative study was conducted as part of a Stage 1 single arm trial with one-year follow-up. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants’ mindfulness skills towards modifiable determinants of blood pressure. Four focus group discussions were conducted (N = 19 participants), and seven additional participants were selected for in-depth interviews. Data analysis was conducted using the standard approach of thematic analysis. Following double-coding of audio-recorded transcripts, four members of the study team engaged in an iterative process of data analysis and interpretation.Results
Participants identified self-awareness, attention control, and emotion regulation as key mechanisms that led to improvements in cardiovascular health. Within these broader themes, many participants detailed a process beginning with increased self-awareness to sustain attention and regulate emotions. Many also explained that the specific relationship between self-awareness and emotion regulation enabled them to respond more skillfully to stressors. In a secondary sub-theme, participants suggested that higher self-awareness helped them engage in positive health behaviors (e.g. healthier dietary choices).Conclusion
Qualitative analyses suggest that MB-BP mindfulness practices allowed participants to engage more effectively in self-regulation skills and behaviors lowering cardiovascular disease risk, which supports recent theory. Results are consistent with quantitative mechanistic findings showing emotion regulation, perceived stress, interoceptive awareness, and attention control are influenced by MB-BP.
by Anna Migdalska‐Richards, Michal Wegrzynowicz, Ian F. Harrison, Guglielmo Verona, Vittorio Bellotti, Maria Grazia Spillantini, Anthony H. V. SchapiraParkinson disease is the most common neurodegenerative movement disorder, estimated to affect one in twenty-five individuals over the age of 80. Mutations in glucocerebrosidase 1 (GBA1) represent the most common genetic risk factor for Parkinson disease. The link between GBA1 mutations and α-synuclein accumulation, a hallmark of Parkinson disease, is not fully understood. Following our recent finding that Gba1 mutations lead to increased α-synuclein accumulation in mice, we have studied the effects of a single injection of mouse α-synuclein pre-formed fibrils into the striatum of Gba1 mice that carry a L444P knock-in mutation. We found significantly greater formation and spread of α-synuclein inclusions in Gba1-transgenic mice compared to wild-type controls. This indicates that the Gba1 L444P mutation accelerates α-synuclein pathology and spread.
Even though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.
We will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and
This master protocol received favourable ethical opinion from National Health Service East of England—Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.
Commentary on: Arantzamendi M, Garcia-Rueda N, Carvajal A, et al. People with advanced cancer: the process of living well with awareness of dying. Qual Health Res 2018. doi: 10.1177/1049732318816298. [Epub ahead of print 12 Dec 2018].
The process of living well with advanced cancer revolves around an ‘awareness of dying’. This leads to a focus on living a life rather than living an illness. To support development of the theory, future research should explore its applicability in both a family perspective and different cultural contexts.
The process of living well with advanced cancer revolves around an ‘awareness of dying’. This leads to a focus on living a life rather than living an illness.
To support development of the theory, future research should explore its applicability in both a family perspective and different cultural contexts.
Little is known about the process of living well with advanced cancer or how to support it.
Commentary on: Elmokhallalati Y, Woodhouse N, Farragher T, et al. Specialist palliative care support is associated with improved pain relief at home during the last 3 months of life in patients with advanced disease: analysis of 5-year data from the national survey of bereaved people (VOICES). BMC Med 2019. https://doi.org/10.1186/s12916-019-1287-8.
People who receive specialist palliative care or have a stated preference to die at home have a significantly higher chance of experiencing good pain relief as they die, irrespective of their disease aetiology. People dying with cancer receive better pain relief than those dying of non-cancer disease. Access to specialist palliative care services and advance care planning should be available to all; irrespective of diagnosis. Researchers and policymakers should consider how to ensure improvements in pain management for patients at home through advice and support from community...
People who receive specialist palliative care or have a stated preference to die at home have a significantly higher chance of experiencing good pain relief as they die, irrespective of their disease aetiology.
People dying with cancer receive better pain relief than those dying of non-cancer disease.
Access to specialist palliative care services and advance care planning should be available to all; irrespective of diagnosis.
Researchers and policymakers should consider how to ensure improvements in pain management for patients at home through advice and support from community...
National data suggest that surgical site infection (SSI) complicates 2%–10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment.
This is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention – use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test.
This is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request.
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.
To determine whether neighbourhood-level socioenvironmental factors including deprivation and inequality predict variance in psychotic symptoms after controlling for individual-level demographics.
A cross-sectional design was employed.
Data were originally collected from secondary care services within the UK boroughs of Ealing, Hammersmith and Fulham, Wandsworth, Kingston, Richmond, Merton, Sutton and Hounslow as part of the West London First-Episode Psychosis study.
Complete case analyses were undertaken on 319 participants who met the following inclusion criteria: aged 16 years or over, resident in the study’s catchment area, experiencing a first psychotic episode, with fewer than 12 weeks’ exposure to antipsychotic medication and sufficient command of English to facilitate assessment.
Symptom dimension scores, derived from principal component analyses of the Scale for the Assessment of Positive Symptoms and Scale for the Assessment of Negative Symptoms, were regressed on neighbourhood-level predictors, including population density, income deprivation, income inequality, social fragmentation, social cohesion, ethnic density and ethnic fragmentation, using multilevel regression. While age, gender and socioeconomic status were included as individual-level covariates, data on participant ethnicity were not available.
Higher income inequality was associated with lower negative symptom scores (coefficient=–1.66, 95% CI –2.86 to –0.46, p
These findings provide further evidence that particular characteristics of the environment may be linked to specific symptom clusters in psychosis. Longitudinal studies are required to begin to tease apart the underlying mechanisms involved as well as the causal direction of such associations.
To assess family satisfaction with intensive care units (ICUs) in the UK using the Family Satisfaction in the Intensive Care Unit 24-item (FS-ICU-24) questionnaire, and to investigate how characteristics of patients and their family members impact on family satisfaction.
Prospective cohort study nested within a national clinical audit database.
Stratified, random sample of 20 adult general ICUs participating in the Intensive Care National Audit & Research Centre Case Mix Programme.
Family members of patients staying at least 24 hours in ICU were recruited between May 2013 and June 2014.
Consenting family members were sent a postal questionnaire 3 weeks after the patient died or was discharged from ICU. Up to four family members were recruited per patient.
Family satisfaction was measured using the FS-ICU-24 questionnaire.
A total of 12 346 family members of 6380 patients were recruited and 7173 (58%) family members of 4615 patients returned a completed questionnaire. Overall and domain-specific family satisfaction scores were high (mean overall family satisfaction 80, satisfaction with care 83, satisfaction with information 76 and satisfaction with decision-making 73 out of 100) but varied significantly across adult general ICUs studied and by whether the patient survived ICU. For family members of ICU survivors, characteristics of both the family member (age, ethnicity, relationship to patient (next-of-kin and/or lived with patient) and visit frequency) and the patient (acute severity of illness and receipt of invasive mechanical ventilation) were significant determinants of family satisfaction, whereas, for family members of ICU non-survivors, only patient characteristics (age, acute severity of illness and duration of stay) were significant.
Overall family satisfaction in UK adult general ICUs was high but varied significantly. Adjustment for differences in family member/patient characteristics is important to avoid falsely identifying ICUs as statistical outliers.
(a) Determine relationships among stress exposure, inflammation, and neurodevelopment in very preterm infants and determine the mediated effect of inflammation on the relationship between stress exposure and neurodevelopment; (b) describe cytokine trajectories following birth and determine the effect of stress exposure on these trajectories; and (c) examine relationships between stress exposure and chronic stress responses in very preterm infants.
Non‐experimental, repeated measures.
Very preterm infants born 28–31 weeks post menstrual age will be enrolled. Cumulative stress exposure over the first 14 days of life will be measured using the Neonatal Infant Stressor Scale. Blood will be collected weekly for the quantification of cytokines. Neurodevelopment will be assessed using the Neurobehavioral Assessment of the Preterm Infant and hair for quantification of hair cortisol will be collected at 35 weeks post menstrual age. Multiple linear regression and conditional process analysis will be used to analyse the relationships among stress exposure, inflammation and neurodevelopment. Linear mixed models will be used to determine inflammatory trajectories over time. IRB approval for the study was received May 2017, and funding from the National Institute of Nursing Research was awarded July 2017.
This study will determine the extent to which inflammation mediates the relationship between stress exposure and neurodevelopment. Interventions to attenuate inflammation in preterm infants may improve outcomes.
Determining the potentially modifiable mediators of stress exposure and neurodevelopment in preterm infants is critical to improving long‐term outcomes.
(a) 确定极早早产儿应激暴露、炎症和神经发育之间的关系,并确定炎症在应激暴露和神经发育之间关系中介导的作用;(b)描述出生后的细胞因子轨迹,并确定应激暴露对这些轨迹的影响; (c)研究极早早产儿的应激暴露与慢性应激反应之间的关系。
Commentary on: Liu N-Y, Hsu W-Y, Hung C-A, et al. The effect of gender role orientation on student nurses' caring behaviour and critical thinking. Int J Nurs Stud 2019;89:18–23.
Gender role orientation (masculine or feminine traits) rather than sex is a predictor for determining caring behaviour and critical thinking skills among student nurses. Student nurses’ caring behaviour should be emphasised to cultivate students’ critical thinking skills.
Gender role orientation (masculine or feminine traits) rather than sex is a predictor for determining caring behaviour and critical thinking skills among student nurses.
Student nurses’ caring behaviour should be emphasised to cultivate students’ critical thinking skills.
Previous research on the relationship between nurses’ gender and perceptions of caring behaviours or critical thinking is inconsistent. Research has shown that gender does not significantly influence caring behaviour
The aim of the study
To determine the prevalence, nature and predictors of patients having medication administration omissions in hospitals.
All medication administration omissions data collected using the standardised methodology of the Medication Safety Thermometer in January 2015 were examined. Hospital inpatients prescribed at least one medication were included in the analysis. Multilevel logistic regression models ascertained the effects of patients’ gender, age, number of prescribed medicines, ward specialty and medicines reconciliation initiation status on the likelihood of having omissions. Valid clinical reasons (VCRs) were excluded from regression models. A sensitivity analysis, excluding patient refusal (PR) omissions, was also conducted.
The final study sample included 5708 patients from 320 wards in 37 hospitals. Excluding VCRs, 30% of patients had medication administration omissions (95% CI 29 to 30). Approximately half of patients with omissions had refused medicines (51%, 95% CI 49 to 53). Univariable analysis suggested that all variables were significantly associated with omissions. However, in the multivariable model, significant differences were only observed regarding the numbers of medicines patients were prescribed and their ward specialty. Patients prescribed more than 20 medications were approximately five times more likely to have had omissions than patients prescribed one to four medications (OR 4.99, 95% CI 3.22 to 7.73). Patients on surgical wards were also more likely to have had omissions than those on medical wards (OR 1.58, 95% CI 1.14 to 2.18, p=0.006), but there was no significant difference when PRs were excluded (OR 0.5, 95% CI 0.27 to 1.22, p=0.473).
Medication administration omissions are a substantial problem that affect many hospital patients, and certain patient groups are at higher risk. Specific interventions are required targeting the underlying reasons for medication omissions for different patient subgroups.
The traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.
The OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.
We repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.
Although OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.
The use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.
Substance use disorders are chronic conditions that require a multidimensional treatment approach. Despite ongoing efforts to diversify such treatments, evidence continues to illuminate modest rates of treatment engagement and perceived barriers to treatment. Patient-centred care (PCC) is one approach that may strengthen the responsiveness of treatments for people with problematic substance use. The aim of this scoping review is to explore how the principles of PCC have been implemented and operationalised in healthcare settings for people with problematic substance use.
This scoping review follows the iterative stages of the Arksey and O’Malley framework. Both empirical (from Medline, Embase, PsycINFO, CINAHL and ISI Web of Science) and grey literature references will be considered if they focused on populations with problematic substance use and described or measured PCC or one of its principles in a health-oriented context. Two reviewers will independently screen references in two successive stages of title/abstract screening and then full-text screening for references meeting title/abstract criteria. A descriptive overview, tabular and/or graphical summaries, and a directed content analysis will be carried out on extracted data. This scoping review has been registered with Open Science Framework (https://osf.io/5swvd/).
This review will systematically examine the extent and nature of existing evidence of PCC in addiction research and clinical practice. Such evidence will contribute to the operationalisation of PCC for people with problematic substance use. A multidisciplinary team has been gathered to represent the needs of people with problematic substance use, healthcare providers and decision-makers. The team’s knowledge users will be engaged throughout this review and will participate in dissemination activities (eg, workshops, presentations, publications, reports).
Long-stay patients in acute hospitals commonly present with complex psychosocial needs and use high levels of hospital resources.
To determine whether a specialist social worker-led model of care was associated with a reduction in length of stay for medically stable patients with complex psychosocial needs who were at risk of long stay, and to determine the economic value of this model relative to the decision makers’ willingness to pay for bed days released.
A prospective, matched cohort study with historical controls.
A large, tertiary teaching and referral hospital in metropolitan Southeast Queensland, Australia.
Length of hospital stay for a cohort of patients seen under the specialist social worker-led model of care was compared with a matched control group of patients admitted to the hospital prior to the introduction of the new model of care using a multistate model with the social worker model of care as an intermediate event. Costs associated with the model of care were calculated and an estimate of the ‘cost per bed day’ was produced.
The model of care reduced mean length of stay by 33 days. This translated to 9999 bed days released over 12 months. The cost to achieve this was estimated to be $A229 000 over 12 months. The cost per bed day released was $23, which is below estimates of hospital decision makers’ willingness to pay for a bed day to be released for an alternate use.
The specialist social worker-led model of care was associated with a reduced length of stay at a relatively low cost. This is likely to represent a cost-effective use of hospital resources. The limitations of our historic control cohort selection mean that results should be interpreted with caution. Further research is needed to confirm these findings.