Multimorbidity, the co-occurrence of a chronic physical condition and mental disorder, affects a substantial number of children and youth and can lead to compromised quality of life, hardship for families, and an increased burden on the healthcare system. We are conducting a study to document the course of mental disorder in children and youth diagnosed with a chronic physical condition; identify predictors of child and youth multimorbidity; examine whether the effects of these predictors are moderated by relevant psychosocial and biological factors; explore potential inflammatory and stress biomarkers that mediate the onset of child and youth multimorbidity; and, assess whether multimorbidity in children and youth alters patterns of mental health service use.
Multimorbidity in Children and Youth Across the Life-course (MY LIFE) is a prospective study. Two hundred and fifty children and youth aged 2–16 years diagnosed with a chronic physical condition along with one parent will be recruited from the outpatient clinics at a paediatric tertiary care centre. Data will be collected using a multi-informant, multimethod design at four time-points (at recruitment, and at 6, 12 and 24 months postrecruitment). Parents will provide reports for all children/youth. In addition, youth ≥10 years will self-report. Mental disorder will be assessed using structured interviews. On completion of data collection, participant-reported data will be linked to provincial health records to identify mental health services use. Multilevel analyses (survival, proportional hazard, structural equation modelling) will be used to address MY LIFE objectives.
This study has been approved by the University of Waterloo Human Research Ethics Board and the Hamilton Integrated Research Ethics Board. Findings will be disseminated to key stakeholders using a number of outlets (peer-reviewed publications and conferences, lay informational pamphlets, social media).
This study determines the magnitude and pattern of animal-related injury mortalities and morbidities in rural Bangladesh.
A cross-sectional survey was conducted in 51 Unions of 7 subdistricts of Bangladesh from June 2013 to September 2013.
A total of approximately 1.17 million individuals across all age and gender profiles were included in the survey. The participants had to be residents of the seven subdistricts and have provided consent to participate in the study.
Animal-related injury characteristics and demographic information was collected in the study. Frequency, proportion and 95% CIs of variables such as type of animal, type of animal attack, activity of the person prior to attack and the seasonality of the injury were reported. Data was then statistically analysed for associations between injury and sociodemographic characteristics.
The incidence rate of fatal and non-fatal animal-related injuries across all ages were 0.7 (95% CI 0.4 to 1.4) and 1635.3 (95% CI 1612.0 to 1658.0) per 100 000 populations, respectively. Non-fatal animal-related injury rates were highest among adults 18 years and older (1820.6 per 100 000 population (1777.2 to 1865.1)), and in males across all age groups. The most common animal injury was wasp/hornet/bee sting (49%), followed by cow/buffalo (25%), dog bite (9%) and snake bites (9%).
Animal-related injuries are an important public health issue in rural Bangladesh. The incidence of animal-related morbidities was found high in the study area. Males, school-going and productive age groups were at high risk. Immediate attention should be given to prevent these events.
by Wouter Schakel, Christina Bode, Peter M. van de Ven, Hilde P. A. van der Aa, Carel T. J. Hulshof, Gerardus H. M. B. van Rens, Ruth M. A. van NispenBackground
Fatigue is a disabling problem in patients with visual impairment, but its etiology is still poorly understood. Our objective was to identify the determinants of fatigue in adults with visual impairment compared to adults with normal sight.Methods
Cross-sectional data on fatigue and sociodemographic, psychological and health-related factors was obtained with validated questionnaires. Structural equational modeling using hypothesized relationships and explorative analyses were used to identify (in)direct pathways contributing to fatigue in 247 adults with visual impairment. The model was then tested in a reference group of 151 adults with normal sight.Results
The final model explained 64% of fatigue variance in participants with visual impairment and revealed the following factors to be directly associated with fatigue: depressive symptoms (β = 0.723, pp = 0.004), accommodative coping (β = 0.116, p = 0.030) and somatic comorbidity (β = 0.311, p = 0.001). Self-efficacy demonstrated a beneficial indirect effect on fatigue (β = -0.228, pp Conclusions
These findings suggest that depression and perceived health are important mediating factors that contribute to fatigue in persons with visual impairment and normal sight. In contrast, somatic comorbidity, sleep disorders and accommodative coping seem to have a specific contribution to vision-related fatigue. These factors should be addressed in interventions to assist individuals with visual impairment in dealing with fatigue.
Frailty is a major clinical geriatric syndrome associated with serious adverse events including functional disability, falls, hospitalisation, increased morbidity and mortality. The aim of this study was to study associations between a frailty phenotype and frailty characteristics well known from the literature.
Registry-based cross-sectional study.
The target population consists of inhabitants above the age of 50 living in the Danish municipalities of Lolland and Guldborgsund. Excluded are incapacitated people, inhabitants unable to understand Danish or English and inhabitants without a permanent residence.
7327 individuals aged 50+ years were included.
We examined associations between the frailty measurement and factors known to be associated with frailty: sex, age, income insufficiency, education, comorbidity, self-assessed health, morbidity and mortality.
7327 individuals aged 50+ years were included. Of these, 6.5% had ≥3 frailty components (frail), 46.7% had 1–2 components (prefrail) and 46.9% had none (non-frail). Those who were frail were older and more likely female than those who were non-frail or prefrail. There was a stepwise decrease in educational level, and in self-assessed health with increasing frailty status, and a stepwise increase in difficulty in making ends meet, number of hospital contacts and mortality with increasing frailty status, p
Based on these findings, we consider the Lolland-Falster Health Study frailty assessment a valid instrument demonstrating the same characteristics as other validated frailty measures concerning associations with sex, age, income insufficiency, education, comorbidity, self-assessed health, morbidity and mortality.
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.
This is a study protocol to investigate nurses' perspectives on refugee health care in two countries. The aims are to: (a) explore self‐reported work environment factors, including work stressors, self‐rated leadership, staffing and resources adequacy, and teamwork among Jordanian and Lebanese nurses caring for refugees; (b) investigate the relationship between nurse related outcomes (physical health; emotional exhaustion) and their psychosocial work environment; and (c) assess the association between nurses' perceived work environment factors and implicit rationing of care and quality of patient care.
Globally, the care of refugees is achieving increased attention. Over 6.3 million people are internally displaced and 4.8 million recorded Syrian expatriates are residing in and receiving healthcare services in the neighbouring host countries.
This is a cross‐sectional, comparative study using a survey design.
The study setting involves both private and public hospitals and primary healthcare centres that provide care to refugees on regular basis in Lebanon and Jordan. The estimated sample size includes 3,000 Registered Nurses from Lebanon and 2,500 nurses and midwives from Jordan.
Workplace factors affecting quality of nursing care and psychosocial status of nurses caring for refugees will be identified. Potential findings will help leaders design interventions to support nurses who are serving refugees for safer care and better patient outcomes. Findings will assist in more efficient resource allocation and management.
New knowledge on the impact of providing health care for refugees will be generated based on the structure of nursing care (e.g., work environment), on the nursing process (e.g., implicit rationing of care), and nurse outcomes (health) in two hosting communities. Moreover, factors enabling resilience in patients, providers, and systems will be identified and be of potential use in addressing the growing global problem of caring for displaced persons.
Skin is important in Australian Aboriginal culture informing kinship and identity. In many remote Aboriginal communities, scabies and impetigo are very common. Untreated skin infections are painful, itchy and frequently go untreated due to under-recognition and lack of awareness of their potential serious complications. We hypothesise that the skin infection burden in remote Aboriginal communities can be reduced by implementing streamlined training and treatment pathways integrated with environmental health and health promotion activities, tested in the See, Treat, Prevent (SToP skin sores and scabies) trial.
SToP will evaluate a skin control programme using a stepped-wedge, cluster randomised trial design with three intervention components (the ‘SToP activities’): (1) seeing skin infections (development of training resources implemented within a community dermatology model); (2) treating skin infections (employing the latest evidence for impetigo, and scabies treatment); and (3) preventing skin infections (embedded, culturally informed health promotion and environmental health activities). Four community clusters in the remote Kimberley region of Western Australia will participate. Following baseline data collection, two clusters will be randomly allocated to the SToP activities. At 12 months, the remaining two clusters will transition to the SToP activities. The primary outcome is the diagnosis of impetigo in children (5–9 years) at school-based surveillance. Secondary outcome measures include scabies diagnosis, other child health indicators, resistance to cotrimoxazole in circulating pathogenic bacteria, determining the economic burden of skin disease and evaluating the cost effectiveness of SToP activities.
This study protocol was approved by the health ethics review committees at the Child and Adolescent Health Service (Approval number RGS0000000584), the Western Australian Aboriginal Health Ethics Committee (Reference number: 819) and the University of Western Australia (Reference RA/4/20/4123). Study findings will be shared with community members, academic and medical communities via publications and presentations, and in reports to funders. Authorship for all publications based on this study will be determined in line with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals published by the International Committee of Medical Journal Editors. Sharing results with organisations and communities who contributed to the study is paramount. The results of the SToP trial will be shared with participants in a suitable format, such as a single summary page provided to participants or presentations to communities, the Kimberly Aboriginal Health Planning Forum Research Subcommittee and other stakeholders as appropriate and as requested. Communication and dissemination will require ongoing consultation with Aboriginal communities to determine appropriate formats.
To evaluate the risk profile, achievement of cardiometabolic goals, and frequency and optimal use of cardiovascular preventive therapies among nonagenarians with type 2 diabetes mellitus (T2DM). To investigate possible sex differences.
A cross-sectional population study of 11 645 persons aged ≥90 years with T2DM living in Madrid (Spain). Sociodemographic, clinical and therapy profiles were collected through electronic records in primary care. We considered antihypertensive therapy and lipid-lowering therapy to be optimal when known patients with hypertension with albuminuria received renin–angiotensin system blockers and statins had been prescribed for overt cardiovascular disease.
The prevalence of coronary artery disease was higher in males than in females (21.5% vs 12.6%, p
Our study showed that the risk of cerebrovascular disease was similar in both male and female Spanish nonagenarians. Adherence was poorer in females for all criteria of optimal use of cardiovascular preventive therapies. Our findings indicate that the known sex differences in younger patients with T2DM persist in patients aged ≥90 years. There is considerable room for improvement in standards of preventive care in nonagenarians with T2DM, especially in females.
Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment.
We will undertake a randomised, controlled, multicentre, unblinded, pilot trial comparing two care pathways: continuing milk feeds (before, during and after red cell transfusions) and withholding milk feeds (for 4 hours before, during and for 4 hours after red cell transfusions), with infants randomly assigned with equal probability. We will use opt-out consent. A nested qualitative study will explore parent and health professional views. Infants will be eligible if born at
This study holds Research Ethics Committee approval to use an opt-out approach to consent. Results will inform future EPR-embedded and data-enabled trials and will be disseminated through conferences, publications and parent-centred information.
ISRCTN registry ISRCTN62501859; Pre-results.
The rising prevalence of modifiable risk factors (eg, obesity, hypertension and physical inactivity) is causing an increase in possible avoidable complications in patients undergoing cardiac surgery. This study aims to assess whether a combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme) can improve functional status and reduce surgical complications, readmissions and major adverse cardiac events (MACE) as compared with standard care.
Patients (n=350) are randomised to the Heart-ROCQ programme or standard care. The Heart-ROCQ programme consists of a preoperative optimisation phase while waiting for surgery (three times per week, minimum of 3 weeks), a postoperative inpatient phase (3 weeks) and an outpatient CR phase (two times per week, 4 weeks). Patients receive multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation). Standard care consists of 6 weeks of postsurgery outpatient CR with education and physical therapy (two times per week). The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee. The secondary outcomes are length of stay, physical and psychological functioning, lifestyle risk factors, and work participation. Finally, an economic evaluation is performed. Data are collected at six time points: at baseline (start of the waiting period), the day before surgery, at discharge from the hospital, and at 3, 7 and 12 months postsurgery.
This study will be conducted according to the principles of the Declaration of Helsinki (V.8, October 2013). The protocol has been approved by the Medical Ethical Review Board of the UMCG (no 2016/464). Results of this study will be submitted to a peer-reviewed scientific journal and can be presented at national and international conferences.
To review what is known about the relationship between stillbirth and inequalities from different disciplinary perspectives to inform stillbirth prevention strategies.
Systematic review using the meta-narrative method.
Studies undertaken in the UK.
Scoping phase: experts in field, exploratory electronic searches and handsearching. Systematic searches phase: Nine databases with no geographical or date restrictions. Non-English language studies were excluded.
Any investigation of stillbirth and inequalities with a UK component.
Three authors extracted data and assessed study quality. Data were summarised, tabulated and presented graphically before synthesis of the unfolding storyline by research tradition; and then of the commonalities, differences and interplays between narratives into resultant summary meta-themes.
Fifty-four sources from nine distinctive research traditions were included. The evidence of associations between social inequalities and stillbirth spanned 70 years. Across research traditions, there was recurrent evidence of the social gradient remaining constant or increasing, fuelling repeated calls for action (meta-theme 1: something must be done). There was less evidence of an effective response to these calls. Data pertaining to socioeconomic, area and ethnic disparities were routinely collected, but not consistently recorded, monitored or reported in relation to stillbirth (meta-theme 2: problems of precision). Many studies stressed the interplay of socioeconomic status, deprivation or ethnicity with aggregated factors including heritable, structural, environmental and lifestyle factors (meta-theme 3: moving from associations towards intersectionality and intervention(s)). No intervention studies were identified.
Research investigating inequalities and stillbirth in the UK is underdeveloped. This is despite repeated evidence of an association between stillbirth risk and poverty, and stillbirth risk, poverty and ethnicity. A specific research forum is required to lead the development of research and policy in this area, which can harness the multiple relevant research perspectives and address the intersections between different policy areas.
To assess the three key issues for congenital anomalies (CAs) prevention and care, namely, CA prevalence, risk factor prevalence and survival, in a longitudinal cohort in Riyadh, Saudi Arabia.
Tertiary care centre, Riyadh, Saudi Arabia.
Saudi women enrolled during pregnancy over 3 years and their 28 646 eligible pregnancy outcomes (births, stillbirths and elective terminations of pregnancy for foetal anomalies). The nested case-control study evaluated the CA risk factor profile of the underlying cohort. All CA cases (1179) and unaffected controls (1262) were followed through age 2 years. Referred mothers because of foetal anomaly and mothers who delivered outside the study centre and their pregnancy outcome were excluded.
Prevalence and pattern of major CAs, frequency of CA-related risk factors and survival through age 2 years.
The birth prevalence of CAs was 412/10 000 births (95% CI 388.6 to 434.9), driven mainly by congenital heart disease (148 per 10 000) (95% CI 134 to 162), renal malformations (113, 95% CI 110 to 125), neural tube defects (19, 95% CI 25.3 to 38.3) and chromosomal anomalies (27, 95% CI 21 to 33). In this study, the burden of potentially modifiable risk factors included high rates of diabetes (7.3%, OR 1.98, 95% CI 1.04 to 2.12), maternal age >40 years (7.0%, OR 2.1, 95% CI 1.35 to 3.3), consanguinity (54.5%, OR 1.5, 95% CI 1.28 to 1.81). The mortality for live births with CAs at 2 years of age was 15.8%.
This study documented specific opportunities to improve primary prevention and care. Specifically, folic acid fortification (the neural tube defect prevalence was >3 times that theoretically achievable by optimal fortification), preconception diabetes screening and consanguinity-related counselling could have significant and broad health benefits in this cohort and arguably in the larger Saudi population.
Studies examining potential factors of all-cause mortality comprehensively at community level are rare. Using long-term community-based follow-up study, we examined the association of sociodemographic and behavioural characteristics, metabolic and chronic conditions, and medication and health service utilisation with all-cause mortality.
We followed 4056 participants, aged 18–90 years, for 18 years in the North West Adelaide Health Study (NWAHS). Mortality data were obtained from South Australian (SA) public hospitals and registries including SA births, deaths and marriages, the National Death Index and the NWAHS follow-up. Predictors of all-cause mortality were explored using Cox proportional hazard model, adjusting for potential confounders. We performed subgroup analyses by sex and age.
Mean (SD) age at baseline was 50.4 (16.4) years. Less than half (47.8%) of the participants were men. A total of 64 689.7 person-years from 4033 participants with 18.7 years of follow-up were generated. The median follow-up time was 17.7 years; 614 deaths were recorded. The overall crude death rate was 9.6 (95% CI 8.9 to 10.4) per 1000 person-years. After adjusting for potential confounders, a reduced risk of mortality was significantly associated with being separated or divorced, being in the highest Socioeconomic Indexes for Areas quintile, engaging in moderate exercise, being overweight (body mass index: 25.0–29.9 kg/m2) and per 10% increase in per cent predicted forced expiratory volume in 1 s. We found that the most important predictors of all-cause mortality were sociodemographic and behavioural characteristics. Sociodemographic factors were more important predictors of all-cause mortality in young age bracket compared with older people.
Socioeconomic factors were found to be the most important predictors of all-cause mortality. The study highlights the need to address the social inequalities and strengthen behavioural interventions for different subgroups of population to prevent premature deaths.
Fasting during the month of Ramadan is a significant Islamic religious practice that involves abstinence from food, drink and medication from dawn to dusk. As just under a quarter of the world’s population identifies as Muslim, the effect of fasting on chronic conditions, such as chronic kidney disease (CKD) is a topic of broad relevance. To date, the information in this area has been mixed, with many limitations of previous studies. This study aims to synthesise the evidence of the effect of Ramadan fasting on changes on kidney function, risk factors, episodes of acute kidney injury and impact on the quality of life in patients with CKD or kidney transplant.
A systematic review of the literature will be conducted, using electronic databases such as MEDLINE, Embase, Global Health, CINAHL and Scopus. Original research and grey literature on the effect of Ramadan fasting in adult patients with CKD or renal transplantation will be included. Two reviewers will independently screen articles for inclusion in the review and independently assess the methodology of included studies using a customised checklist. Mean difference or risk ratio will be reported for continuous or dichotomous outcomes and results will be pooled using a random-effects model where heterogeneity is reasonable. If possible, subgroups (CKD status, setting, season and risk of bias) will be analysed for effect modification with fasting and the outcomes of interest. Risk of bias will be assessed using the Downs and Black checklist.
The results will be disseminated using a multifaceted approach to engage all stakeholders (patients, practitioners and community leaders). Research ethics board approval is not required as this is a systematic review of previously published research.
This study assesses the competency of maternal and neonatal health (MNH) professionals at district-level and subdistrict-level health facilities in northern Bangladesh in managing maternal and newborn complications using clinical vignettes. The study also examines whether the professional’s characteristics and provision of MNH services in health facilities influence their competencies.
134 MNH professionals in 15 government hospitals were interviewed during August and September 2016 using structured questionnaire with clinical vignettes on obstetric complications (antepartum haemorrhage and pre-eclampsia) and neonatal care (low birthweight and immediate newborn care). Summative scores were calculated for each vignette and median scores were compared across different individual-level and health facility-level attributes to examine their association with competency score. Kruskal-Wallis test was performed to identify the significance of association considering a p value
The competency of MNH professionals was low. About 10% and 24% of the health professionals received ‘high’ scores (>75% of total) in maternal and neonatal vignettes, respectively. Medical doctors had higher competency than nurses and midwives (score=11 vs 8 out of 19, respectively; p=0.0002) for maternal vignettes, but similar competency for neonatal vignettes (score=30.3 vs 30.9 out of 50, respectively). Professionals working in health facilities with higher use of normal deliveries had better competency than their counterparts. Professionals had higher competency in newborn vignettes (significant) and maternal vignettes (statistically not significant) if they worked in health facilities that provided more specialised newborn care services and emergency obstetric care, respectively, in the last 6 months.
Despite the overall low competency of MNH professionals, exposure to a higher number of obstetric cases at the workplace was associated with their competency. Arrangement of periodic skill-based and drill-based in-service training for MNH professionals in high-use neighbouring health facilities could be a feasible intervention to improve their knowledge and skill in obstetric and neonatal care.
To examine whether any differential change in emergency admissions could be attributed to integrated care by comparing pioneer and non-pioneer populations from a pre-pioneer baseline period (April 2010 to March 2013) over two follow-up periods: to 2014/2015 and to 2015/2016.
Difference-in-differences analysis of emergency hospital admissions from English Hospital Episode Statistics.
Local authorities in England classified as either pioneer or non-pioneer.
Emergency admissions to all NHS hospitals in England with local authority determined by area of residence of the patient.
Wave 1 of the integrated care and support pioneer programme announced in November 2013.
Change in hospital emergency admissions.
The increase in the pioneer emergency admission rate from baseline to 2014/2015 was smaller at 1.93% and significantly different from that of the non-pioneers at 4.84% (p=0.0379). The increase in the pioneer emergency admission rate from baseline to 2015/2016 was again smaller than for the non-pioneers but the difference was not statistically significant (p=0.1879).
It is ambitious to expect unequivocal changes in a high level and indirect indicator of health and social care integration such as emergency hospital admissions to arise as a result of the changes in local health and social care provision across organisations brought about by the pioneers in their early years. We should treat any sign that the pioneers have had such an impact with caution. Nevertheless, there does seem to be an indication from the current analysis that there were some changes in hospital use associated with the first year of pioneer status that are worthy of further exploration.
In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.
The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.
The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.
Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.
Phase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study.
The clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).
If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients.
Effective secondary stroke prevention strategies are suboptimally used. Novel development of interventions to enable healthcare professionals and stroke survivors to manage risk factors for stroke recurrence are required. We sought to engage key stakeholders in the design and evaluation of an intervention informed by a learning health system approach, to improve risk factor management and secondary prevention for stroke survivors with multimorbidity.
Qualitative, including focus groups, semistructured interviews and usability evaluations. Data was audio recorded, transcribed and coded thematically.
Stroke survivors, carers, health and social care professionals, commissioners, policymakers and researchers.
Stroke survivors were recruited from the South London Stroke Register; health and social care professionals through South London general practices and King’s College London (KCL) networks; carers, commissioners, policymakers and researchers through KCL networks.
53 stakeholders in total participated in focus groups, interviews and usability evaluations. Thirty-seven participated in focus groups and interviews, including stroke survivors and carers (n=11), health and social care professionals (n=16), commissioners and policymakers (n=6) and researchers (n=4). Sixteen participated in usability evaluations, including stroke survivors (n=8) and general practitioners (GPs; n=8). Eight themes informed the collaborative design of DOTT (Deciding On Treatments Together), a decision aid integrated with the electronic health record system, to be used in primary care during clinical consultations between the healthcare professional and stroke survivor. DOTT aims to facilitate shared decision-making on personalised treatments leading to improved treatment adherence and risk control. DOTT was found acceptable and usable among stroke survivors and GPs during a series of evaluations.
Adopting a user-centred data-driven design approach informed an intervention that is acceptable to users and has the potential to improve patient outcomes. A future feasibility study and subsequent clinical trial will provide evidence of the effectiveness of DOTT in reducing risk of stroke recurrence.
Engaging stakeholders in reviews is considered to generate more relevant evidence and to facilitate dissemination and use. As little is known about stakeholder involvement, we assessed the characteristics of their engagement in systematic and rapid reviews and the methodological quality of included studies. Stakeholders were people with a particular interest in the research topic.
Four databases (Medline, Embase, Cochrane database of systematic reviews, databases of the University of York, Center for Reviews and Dissemination (CRD)) were searched based on an a priori protocol. Four types of reviews (Cochrane and non-Cochrane systematic reviews, rapid and CRD rapid reviews) were retrieved between January 2011 and October 2015, pooled by potential review type and duplicates excluded. Articles were randomly ordered and screened for inclusion and exclusion criteria until 30 reviews per group were reached. Their methodological quality was assessed using AMSTAR and stakeholder characteristics were collected.
In total, 57 822 deduplicated citations were detected with potential non-Cochrane systematic reviews being the biggest group (56 986 records). We found stakeholder involvement in 13% (4/30) of Cochrane, 20% (6/30) of non-Cochrane, 43% (13/30) of rapid and 93% (28/30) of CRD reviews. Overall, 33% (17/51) of the responding contact authors mentioned positive effects of stakeholder involvement. A conflict of interest statement remained unmentioned in 40% (12/30) of non-Cochrane and in 27% (8/30) of rapid reviews, but not in Cochrane or CRD reviews. At most, half of non-Cochrane and rapid reviews mentioned an a priori study protocol in contrast to all Cochrane reviews.
Stakeholder engagement was not general practice, except for CRD reviews, although it was more common in rapid reviews. Reporting factors, such as including an a priori study protocol and a conflict of interest statement should be considered in conjunction with involving stakeholders.