This cross-sectional study aimed to assess resilience, professional quality of life and coping mechanisms in UK doctors. It also aimed to assess the impact of demographic variables, such as sex, grade and specialty on these factors.
During October and November 2018, medical doctors in the UK were eligible to complete an online survey made up of validated psychological instruments. Royal Colleges and other medical organisations invited their membership to participate via newsletters, email invitations, websites and social media.
1651 doctors participated from a wide range of specialties and grades across the UK. The mean resilience score was 65.01 (SD 12.3), lower than population norms. Of those who responded, 31.5% had high burnout (BO), 26.2% had high secondary traumatic stress and 30.7% had low compassion satisfaction (CS). Doctors who responded from emergency medicine were more burned out than any other specialty group (F=2.62, p=0.001, df 14). Those who responded from general practice scored lowest for CS (F=6.43, p
One-third of UK doctors who responded are burned out and suffering from STS. Those who responded from emergency medicine and general practice appear to be suffering the most. Over 100 doctors fell into the at-risk category of high BO, high STS and low CS. Future analysis of the free text responses from doctors may help to identify factors that are playing a role in the high levels of BO and STS being reported by medical staff.
The effects of interventions targeting weight loss on physical health are well described, yet the evidence for mental health is less clear. It is essential to better understand the impact of weight management interventions on mental health to optimise care and minimise risk of harm. We will assess the effect of behavioural weight management interventions on mental health in adults with overweight and obesity.
The systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. We will include behavioural weight management interventions with a diet and/or physical activity component focusing on weight loss for adults with a body mass index ≥25 kg/m2. Randomised controlled trials (RCTs) and cluster RCTs will be the only eligible study designs. Outcomes of interest will be related to mental health. The following databases were searched from inception to 07 May 2019: MEDLINE, Embase, Cochrane database (CENTRAL), PsycINFO, ASSIA, AMED and CINAHL. The search strategy was based on four concepts: (1) adults, defined as ≥18 years, with overweight/obesity, defined as BMI ≥25kg/m², (2) weight management interventions, (3) mental health outcomes and (4) study design. The search was restricted to English-language published papers, with no other restrictions applied. Two stage screening for eligibility will be completed by two independent reviewers, with two independent reviewers completing data extraction and risk of bias assessment. Data permitting, a random-effects meta-analysis of outcomes, subgroup analyses and meta-regression will be conducted. If not appropriate, narrative synthesis and ‘levels of evidence’ assessment will be completed.
Ethical approval is not required as primary data will not be collected. The completed systematic review will be disseminated in a peer-reviewed journal, at conferences and contribute towards the lead author’s PhD thesis.
Despite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectasis.
The Korean Multicenter Bronchiectasis Audit and Research Collaboration (KMBARC) is a prospective, non-interventional observational cohort study on bronchiectasis in Korea. The inclusion criteria of this registry are as follows: (1) adult patients (aged ≥18 years) with or without respiratory symptoms (cough, chronic sputum and/or recurrent respiratory infection) and chest computed tomography revealing bronchiectasis affecting one or more lobes and (2) stable status at the time of registration: patients with bronchiectasis who were admitted for a respiratory aetiology can be enrolled at least 4 weeks after hospital discharge. The exclusion criteria are as follows: (1) bronchiectasis due to cystic fibrosis; (2) traction bronchiectasis associated with interstitial lung disease; (3) patients actively being treated for pneumonia, pulmonary tuberculosis or non-tuberculous mycobacterial infection; (4) patients who are unable or unwilling to provide informed consent; and (5) pregnant patients. Although the KMBARC questionnaires for baseline and annual follow-up data are similar to the European Multicentre Bronchiectasis Audit and Research Collaboration questionnaires, KMBARC has distinctive features such as use of Bronchiectasis Health Questionnaires, measurement with fatigue and depression scales, blood tests, use of consensus definition of exacerbations and information on emergency room or hospitalisation.
We aim to recruit at least 1200 patients over the study period from more than 26 hospitals in South Korea. Patients will undergo a detailed baseline and yearly assessment for up to 5 years. The study objectives of the KMBARC registry are as follows: (1) uncovering the natural course of bronchiectasis; (2) aiding in establishing evidence-based bronchiectasis guidelines in Korea; and (3) encouraging and facilitating studies on bronchiectasis in Korea.
This study received necessary approval from the Institutional Review Boards of all participating institutions. The Asan Medical Center Institutional Review Board gave overall approval for the study. Results will be disseminated via peer-reviewed publications and conference presentations.
Concerns unique to women with breast cancer can include impact of cancer on body image, sexual well-being and changes in breast appearance and sensation. These important issues are not captured by the existing generic preference-based measures (PBMs) and no breast cancer-specific PBM currently exists. This Phase 1 protocol describes a mixed-methods study to develop and validate the descriptive health state classification system for a breast cancer-specific PBM, called the BREAST-Q Utility module.
A heterogeneous sample of women aged 18 years and older diagnosed with breast cancer who are undergoing or have had treatment for breast cancer will be invited to participate in qualitative interviews. Participants will be asked to describe impact of their diagnosis and treatment(s) on their health-related quality of life (HRQOL). Interviews will be audio recorded, transcribed verbatim and coded using a line-by-line approach. At the end of each interview, based on each participant’s cancer treatment history, patients will complete the mastectomy, breast-conserving therapy or reconstruction module of BREAST-Q, with modified 5-point Likert scale to measure importance of the BREAST-Q concepts. Both sources of data will be analysed to identify the most important HRQOL concerns.
A conceptual framework and item pool will be developed from the qualitative dataset. Preliminary version of the BREAST-Q Utility module will be created and refined at an in-person meeting of multidisciplinary experts. Content validity of the Utility module will be examined (cognitive debriefing, expert feedback). Psychometric properties of Utility module will be evaluated in a large sample of women with breast cancer.
The study has been approved by Hamilton Integrated Research Ethics Board, Canada. Results of this study will be presented at international conferences and published in peer-reviewed journals.
To use wrist-worn accelerometers (Axivity AX3) to establish normative physical activity (PA) and acceptability data for the high-risk elderly preoperative population, to assess whether PA could be modified by a prehabilitation intervention as part of routine care, to assess any correlation between accelerometer-measured PA and self-reported PA and to assess the acceptability of wearing wrist-worn accelerometers in this population.
Prospective, observational, pilot study.
Single National Health Service Hospital.
Frail patients≥65 years awaiting major surgery referred to a multidisciplinary preoperative clinic at which they received a routine intervention aimed at improving their PA. 35 patients were recruited. Average age 79.9 years (SD=5.6).
Normative PA data measured as a mean daily Euclidean norm minus one (ENMO) in milli-gravitational units (mg).
Measure PA levels (mg) following a routine preoperative intervention. Determine correlation between patient-reported PA (measured using the Physical Activity Scale for the Elderly) and accelerometer-measured PA (mg). Assess acceptability of wearing a wrist-worn accelerometer measured using Visual Analogue Scale (VAS) questionnaire and device wear time (hours).
Median baseline daily PA was 14.3 mg (IQR 9.75–22.04) with an improvement in PA detected following the intervention (median ENMO post intervention 20.91 mg (IQR 14.83–27.53), p=0.022). There was no significant correlation between accelerometer-measured and self-reported PA (baseline =0.162 (p=0.4), post intervention =–0.144 (p=0.5)). We found high acceptability ratings (median score of 10/10 on VAS, IQR 8–10) and wear-time compliance (163.2 hours (IQR 150–167.5) preintervention and 166.1 hours (IQR 162.5–167) post intervention).
Accelerometery is acceptable to this population and increases in PA levels measured following an unoptimised routine clinical intervention which indicates that health behavioural change interventions may be successful during the preoperative period. Accelerometers may therefore be a useful tool to design and validate interventions for improving PA in this setting.
Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.
The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.
A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.
Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.
The Korean Urban Rural Elderly (KURE) cohort was initiated to study the epidemiologic characteristics, physical performance, laboratory and imaging biomarkers and incidence of age-related diseases in an elderly population with respect to both clinical and social aspects to develop preventive and therapeutic strategies for combatting age-related diseases.
A total of 3517 adults aged 65 or older participated in the cohort at baseline from 2012 to 2015, recruited from three urban districts and one rural district in Korea. The second-wave follow-up survey is now being conducted at a 4-year interval from baseline (2016–2019; follow-up rate 71.5%). The data set included detailed information on anthropometric and socioeconomic factors, functional assessments, image scans (plain radiography, dual-energy X-ray absorptiometry and CT), biospecimens (ie, serum, urine and DNA) and social support networks along with the feasibility of linkage to a national claims database.
Mean age of participants at entry was 71.9±4.6 years and 67% were women. From the KURE participants enrolled in baseline recruitment, several studies were published in the fields of cardiometabolic diseases, musculoskeletal health and the association between social support network and diseases in ageing.
Participants will be observed actively and passively every 4–5 years and the first follow-up will be completed in 2020. The KURE data set has strength in comprehensive physical function assessments, quantifiable imaging data sets using CT and detailed information regarding the social support networks of participants from a large community-based elderly Korean population.
The Scleroderma Patient-centered Intervention Network (SPIN) Cohort uses the cohort multiple randomised controlled trial design to embed trials of online self-care interventions for people living with systemic sclerosis (SSc; scleroderma). To offer interventions to patients interested in using them, participants complete signalling items that query about the likelihood that patients would agree to participate in nine different hypothetical online programmes addressing common SSc-related problems. It is not known what factors influence patient-reported interest in participating in a particular online intervention and if intervention-specific signalling questions provide unique information or replicate broader characteristics, such as overall willingness to participate or self-efficacy. This study assessed factors that explain responses to intervention-specific signalling items.
SPIN Cohort participants enrolled at 42 centres from Canada, the USA, the UK, France, Spain and Mexico who completed study questionnaires from March 2014 to January 2018 were included.
Demographic and disease characteristics, self-efficacy and symptoms related to each specific intervention were completed in addition to signalling items. General likelihood of using interventions was calculating by taking the mean score of the remaining signalling questions.
1060 participants with complete baseline data were included in the analyses.
For all individual signalling questions, controlling for other variables, the mean of the remaining signalling questions was the strongest predictor (standardised regression coefficient β from 0.61 (sleep) to 0.80 (self-management)). Smaller, but statistically significant, associations were found with the symptom associated with the respective signalling question and with general self-efficacy for 7 of 9 signalling questions.
The main factor associated with patients’ interest in participating in a disease-specific online self-care intervention is their general interest in participating in online interventions. Factors that may influence this general interest should be explored and taken into consideration when inviting patients to try online interventions.
Effective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quality in Tanzania. We hypothesise that Safe Surgery 2020 will (1) increase adherence to surgical quality processes around safety, teamwork and communication and data quality in the short term and (2) reduce complications from surgical site infections, postoperative sepsis and maternal sepsis in the medium term.
Our design is a prospective, longitudinal, quasi-experimental study with 10 intervention and 10 control facilities in Tanzania’s Lake Zone. Participants will be surgical providers, surgical patients and postnatal inpatients at study facilities. Trained Tanzanian medical data collectors will collect data over a 3-month preintervention and postintervention period. Adherence to safety as well as teamwork and communication processes will be measured through direct observation in the operating room. Surgical site infections, postoperative sepsis and maternal sepsis will be identified prospectively through daily surveillance and completeness of their patient files, retrospectively, through the chart review. We will use difference-in-differences to analyse the impact of the Safe Surgery 2020 intervention on surgical quality processes and complications. We will use interviews with leadership and surgical team members in intervention facilities to illuminate the factors that facilitate higher performance.
The study has received ethical approval from Harvard Medical School and Tanzania’s National Institute for Medical Research. We will report results in peer-reviewed publications and conference presentations. If effective, the Safe Surgery 2020 intervention could be a promising approach to improve surgical quality in Tanzania’s Lake Zone region and other similar contexts.
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 appropriateness of using routinely collected laboratory data combined with administrative data for estimating influenza vaccine effectiveness (VE) is still being explored. This paper outlines a protocol to estimate influenza VE using linked laboratory and administrative data which could act as a companion to estimates derived from other methods.
We will use the test-negative design to estimate VE for each influenza type/subtype and season. Province-wide individual-level records of positive and negative influenza tests at the Provincial Laboratory for Public Health in Alberta will be linked, by unique personal health numbers, to administrative databases and vaccination records held at the Ministry of Health in Alberta to determine covariates and influenza vaccination status, respectively. Covariates of interests include age, sex, immunocompromising chronic conditions and healthcare setting. Cases will be defined based on an individual’s first positive influenza test during the season, and potential controls will be defined based on an individual’s first negative influenza test during the season. One control for each case will be randomly selected based on the week the specimen was collected. We will estimate VE using multivariable logistic regression.
Ethics approval was obtained from the University of Alberta’s Health Research Ethics Board—Health Panel under study ID Pro00075997. Results will be disseminated by public health officials in Alberta.
This article outlines how current nursing research can utilize technology to advance symptom and self‐management science for precision health and provides a roadmap for the development and use of technologies designed for this purpose.
At the 2018 annual conference of the National Institute of Nursing Research (NINR) Research Centers, nursing and interdisciplinary scientists discussed the use of technology to support precision health in nursing research projects and programs of study. Key themes derived from the presentations and discussion were summarized to create a proposed roadmap for advancement of technologies to support health and well‐being.
Technology to support precision health must be centered on the user and designed to be desirable, feasible, and viable. The proposed roadmap is composed of five iterative steps for the development, testing, and implementation of technology‐based/enhanced self‐management interventions. These steps are (a) contextual inquiry, focused on the relationships among humans, and the tools and equipment used in day‐to‐day life; (b) value specification, translating end‐user values into end‐user requirements; (c) design, verifying that the technology/device can be created and developing the prototype(s); (d) operationalization, testing the intervention in a real‐world setting; and (e) summative evaluation, collecting and analyzing viability metrics, including process data, to evaluate whether the technology and the intervention have the desired effect.
Interventions using technology are increasingly popular in precision health. Use of a standard multistep process for the development and testing of technology is essential.
Access to a delivery unit is a major factor in determining maternal morbidity and mortality. However, there is little information about the optimal access time to a delivery unit. This study aimed to establish the optimal hospital access time (OHAT) for pregnant women in South Korea.
Nationwide cross-sectional study.
We used the National Health Insurance System database of South Korea.
We analysed the data of 371 341 women who had experienced pregnancy in 2013.
Access time to hospital was defined as the time required to travel from the patient’s home to the delivery unit. The incidence of obstetric complications was plotted against the access time to hospital. Change-point analysis was performed to identify the OHAT by determining a point wherein the incidence of obstetric complications changed significantly. As a final step, the risk of obstetric complications was compared by type among pregnant women who lived within the OHAT against those who lived outside the OHAT.
The OHAT associated with each adverse pregnancy outcomes were as follows: inadequate prenatal care, 41–50 min; preeclampsia, 51–60 min; placental abruption, 51–60 min; preterm delivery, 31–40 min; postpartum transfusion, 31–40 min; uterine artery embolisation, 31–40 min; admission to intensive care unit, 31–40 min; and caesarean hysterectomy, 31–40 min. Pregnant women who lived outside the OHAT had significantly higher risk for obstetric complications than those who lived within the OHAT.
Our results showed that the OHAT for each obstetric complication ranged between 31 and 60 min. The Korean government should take the OHAT under consideration when establishing interventions for pregnant women who live outside OHAT to reduce maternal morbidity and mortality.
In healthcare systems, practices and products of unproven value and cost-effectiveness can decrease value and increase waste. Using the management of complex wounds, this study investigates temporal trends in the use of antimicrobials dressings, places this in the context of available evidence and discusses the potential impacts on the UK National Health Service (NHS).
Secondary descriptive and interrupted time series (ITS) analysis of NHS prescription data.
Prescribing Cost Analysis (PCA) details all NHS prescriptions dispensed in the community in England.
An ITS design was used to compare annual changes in the expenditure and use of antimicrobial and non-antimicrobial dressings before and after the publication of the ‘intervention’ of key evidence-based Scottish Intercollegiate Guidelines Network (SIGN) guidance in 2010.
Trends in use and expenditure of antimicrobial dressings in relation to published clinical guidance.
There was a large increase in the prescribing of, and expenditure on, antimicrobial wound dressings between 1997 and 2016. In 1997, the total number of dressings prescribed was 5 792 700; increasing to 11 447 102 in 2009 with expenditure increasing from £1 960 386 to £32 841 263. During the year of the SIGN intervention (2010), there was a significant drop in the use of silver but there was no consistent ongoing reduction from 2011 to 2015.
Prescribing data can be used to identify products of unproven benefit, which also impose a significant financial burden. This study quantifies the huge increase in the use of antimicrobial wound dressings over a 20-year period despite the lack of compelling evidence to support their routine use. There is some suggestion, however that the use and expenditure decreased after the publication of key guidance. Routine data can be used to as part of more systematic efforts to increase value and reduce waste in health systems.
The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan have been ranked the highest worldwide. Therefore, the National Health Insurance Administration has implemented the pre-ESRD pay-for-performance (P4P) programme since November 2006, which had significantly reduced the incidence of dialysis and all-cause mortality. This study aimed to identify the factors associated with the enrolment in the pre-ESRD P4P programme.
The National Health Insurance research database 2007–2012 in Taiwan.
Patients with prevalent pre-ESRD aged more than 18 years between January 2007 and December 2012 were enrolled. Patient demographics and hospital characteristics between P4P and non-P4P groups were compared. A logistic regression model was used to analyse the factors associated with P4P enrolment, and a generalised estimating equation was used to verify the results.
Enrolment in the pre-ESRD P4P programme.
In total, 82 991 patients were enrolled in the programme, with a 45.6% participation rate. Patients who were males (adjusted OR (AOR)=0.89, 95% CI=0.86 to 0.91) and employed (AOR=0.95, 95% CI=0.92 to 0.97) had a significantly lower probability to be enrolled in the programme. Older patients (66–75 years old, AOR=1.23, 95% CI=1.14 to 1.33) and those with higher Charlson Comorbidities Index (CCI 5+, AOR=4.01, 95% CI=3.55 to 4.53) tended to be enrolled in the programme, while those in the 76+ years age group were not (AOR=1.03, 95% CI=0.95 to 1.13). Hospitals located in the central (AOR=1.48, 95% CI=1.05 to 2.08) and Kao-Ping regions (AOR=1.62, 95% CI=1.18 to 2.22) also tended to enrol patients in the pre-ESRD P4P programme. Enrolment rates increased over time.
Pre-ESRD patients of the female gender, greater age and more comorbidities were more likely to be enrolled in the pre-ESRD P4P programme. Healthcare providers and health authorities should focus attention on patients who are male, younger and with less comorbidities to improve the healthcare quality and equality for all pre-ESRD patients.
Our aim was to conduct a systematic review of the literature to determine the impact of patient decision aids (PDA) on patients facing treatment decisions for colorectal cancer.
Sources included Embase, Medline, Web of Science, CINAHL and the Cochrane Library from inception to June, 20, 2019.
We included randomised controlled trials (RCTs), cohort studies, mixed methods and case series in which a PDA for colorectal cancer treatment was used. Qualitative studies were excluded from our review.
Following execution of the search strategy by a medical librarian, two blinded independent reviewers identified articles for inclusion. Two blinded reviewers were also responsible for data extraction, risk of bias and study quality assessments. Any conflict in article inclusion or extraction was resolved by discussion.
Out of 3773 articles identified, three met our inclusion criteria: one RCT, one before-and-after study and one mixed-method study. In these studies, the use of a PDA for colorectal cancer treatment was associated with increased patient knowledge, satisfaction and preparation for making a decision. On quality assessment, two of three studies were judged to be of low quality.
A paucity of evidence exists on the effect of PDA for colorectal cancer treatment with existing evidence being largely of low quality. Further investigation is required to determine the effect of decision aids for colorectal cancer treatment as well as reasons for the lack of PDA development and implementation in this area.
Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain.
The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis.
This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations.
Severe limb ischaemia (SLI) is the end stage of peripheral arterial occlusive disease where the viability of the limb is threatened. Around 25% of patients with SLI will ultimately require a major lower limb amputation, which has a substantial adverse impact on quality of life. A newly established rapid-access vascular limb salvage clinic and modern revascularisation techniques may reduce amputation rate. The aim of this study was to investigate the 12-month amputation rate in a contemporary cohort of patients and compare this to a historical cohort. Secondary aims are to investigate the use of frailty and cognitive assessments, and cardiac MRI in risk-stratifying patients with SLI undergoing intervention and establish a biobank for future biomarker analyses.
This single-centre prospective cohort study will recruit patients aged 18–110 years presenting with SLI. Those undergoing intervention will be eligible to undergo additional venepuncture (for biomarker analysis) and/or cardiac MRI. Those aged ≥65 years and undergoing intervention will also be eligible to undergo additional frailty and cognitive assessments. Follow-up will be at 12 and 24 months and subsequently via data linkage with NHS Digital to 10 years postrecruitment. Those undergoing cardiac MRI and/or frailty assessments will receive additional follow-up during the first 12 months to investigate for perioperative myocardial infarction and frailty-related outcomes, respectively. A sample size of 420 patients will be required to detect a 10% reduction in amputation rate in comparison to a similar sized historical cohort, with 90% power and 5% type I error rate. Statistical analysis of this comparison will be by adjusted and unadjusted logistic regression analyses.
Ethical approval for this study has been granted by the UK National Research Ethics Service (19/LO/0132). Results will be disseminated to participants via scientific meetings, peer-reviewed medical journals and social media.
Children with disorders of consciousness (DOC) represent the highest end of the acquired brain injury (ABI) severity spectrum for survivors and experience a multitude of functional impairments. Current clinical management in DOC uses behavioural evaluation measures and interventions that fail to (1) describe the physiological consequences of ABI and (2) elicit functional gains. In paediatric DOC, there is a critical need to develop evidence-based interventions to promote recovery of basic responses to improve rehabilitation and aid decision-making for medical teams and caregivers. The purpose of this investigation is to examine the safety, tolerability and feasibility of transcranial direct current stimulation (tDCS) in children with DOC.
This study is an open-label dose escalation trial evaluating the safety, tolerability and feasibility of tDCS in 10 children (5–17 years) receiving inpatient rehabilitation for DOC. This study will follow a modified rule-based design, allowing for intrapatient escalation, where a cohort of patients will be assigned to an initial tDCS current of 0.5 or 1 mA based on participant’s head circumference and according to the safety data available in other paediatric populations. The subsequent assignment of increased current (1 or 2 mA) according to the prespecified rules will be based on the clinical observation of adverse events in the patients. The study will include up to three, 20 min sessions of anodal tDCS (sham, 0.5 or 1 mA, 1 or 2 mA) applied over the dorsolateral prefrontal cortex. The primary outcomes are adverse events, pain associated with tDCS and intolerable disruption of inpatient care. Secondary outcomes are changes in electroencephalography (EEG) phase-locking and event-related potential components and the Coma Recovery Scale-Revised total score from prestimulation to poststimulation.
The Johns Hopkins IRB (#IRB00174966) approved this study. Trial results will be disseminated through journals and conferences.
To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.
Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).
Four centres in the UK (Birmingham, Cornwall, Gwent and York).
People with heart failure with reduced ejection fraction (HFrEF) and their caregivers.
The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.
Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.
Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.
By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.