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.
Given the exponential increase in the use of e-cigarettes among younger age groups and in the growth in research on e-cigarette flavours, we conducted a systematic review examining the impact of non-menthol flavoured e-cigarettes on e-cigarette perceptions and use among youth and adults.
PubMed, Embase, PyscINFO and CINAHL were systematically searched for studies published and indexed through March 2018.
Quantitative observational and experimental studies that assessed the effect of non-menthol flavours in e-cigarettes on perceptions and use behaviours were included. Specific outcome measures assessed are appeal, reasons for use, risk perceptions, susceptibility, intention to try, initiation, preference, current use, quit intentions and cessation.
Three authors independently extracted data related to the impact of flavours in tobacco products. Data from a previous review were then combined with those from the updated review for final analysis. Results were then grouped and analysed by outcome measure.
The review included 51 articles for synthesis, including 17 published up to 2016 and an additional 34 published between 2016 and 2018. Results indicate that non-menthol flavours in e-cigarettes decrease harm perceptions (five studies) and increase willingness to try and initiation of e-cigarettes (six studies). Among adults, e-cigarette flavours increase product appeal (seven studies) and are a primary reason many adults use the product (five studies). The role of flavoured e-cigarettes on smoking cessation remains unclear (six studies).
This review provides summary data on the role of non-menthol flavours in e-cigarette perceptions and use. Consistent evidence shows that flavours attract both youth and adults to use e-cigarettes. Given the clear findings that such flavours increase product appeal, willingness to try and initiation among youth, banning non-menthol flavours in e-cigarettes may reduce youth e-cigarette use. Longitudinal research is needed to examine any role flavours may play in quit behaviours among adults.
Worldwide, 10%–20% of children and adolescents experience mental health conditions. However, most such disorders remain undiagnosed until adolescence or adulthood. Little is known about the factors that influence mental health in children and adolescents, especially in low and middle-income countries (LMIC), where environmental threats, such as poverty and war, may affect optimal neurodevelopment. Cohort studies provide important information on risks and resilience across the life course by enabling tracking of the effects of early life environment on health during childhood and beyond. Large birth cohort studies, including twin cohorts that can be aetiologically informative, have been conducted within high-income countries but are not generalisable to LMIC. There are limited longitudinal birth cohort studies in LMIC.
We sought to enhance the volume of impactful research in Sri Lanka by establishing a Centre of Excellence for cohort studies. The aim is to establish a register of infant, child and adolescent twins, including mothers pregnant with twins, starting in the districts of Colombo (Western Province) and Vavuniya (Northern Province). We will gain consent from twins or parents for future research projects. This register will provide the platform to investigate the aetiology of mental illness and the impact of challenges to early brain development on future mental health. Using this register, we will be able to conduct research that will (1) expand existing research capacity on child and adolescent mental health and twin methods; (2) further consolidate existing partnerships and (3) establish new collaborations. The initiative is underpinned by three pillars: high-quality research, ethics, and patient and public involvement and engagement (PPIE).
Ethical approval for this study was obtained from the Ethics Review Committee of Sri Lanka Medical Association and Keele University’s Ethical Review Panel. In addition to journal publications, a range of PPIE activities have been conducted.
This study aimed to estimate the association of smoking with the direct medical expenditures for chronic disease management in north of Jordan.
Retrospective cohort study using hospital database. Patients who were diagnosed with at least one chronic disease,were aged 18 years or older and had attended King Abdullah University Hospital for disease management and procedures from 1 July 2015 through 30 June 2016 were included in the study.
The outcome of interest was the direct medical expenditures for chronic disease management according to smoking status.
Data were collected from 845 patients having at least one chronic disease (mean age of 61±10.7 years). Smokers formed 22% of total patients. The back transformed mean total expenditure per patient of smokers, former smokers and non-smokers was 875 JD, 928 JD and 774 JD, respectively. Drugs were the most expensive healthcare resource used, accounting for 43% of total expenditure, followed by inpatient-related and outpatient-related services (19%). Smokers and former smokers were associated with the highest inpatient expenditures and inpatient-related and outpatient-related services expenditures. However, smokers were associated with the lowest outpatient and medication expenditures.
Smokers and former smokers presented with higher statistically significant inpatient-related and outpatient-related services expenditures and higher transformed mean total expenditures compared to non-smokers; highlighting this economic burden is useful for promoting tobacco control policies.
Urban transmission patterns of influenza viruses are complex and poorly understood, and multiple factors may play a critical role in modifying transmission. Whole genome sequencing (WGS) allows the description of patient-to-patient transmissions at highest resolution. The aim of this study is to explore urban transmission patterns of influenza viruses in high detail by combining geographical, epidemiological and immunological data with WGS data.
The study is performed at the University Hospital Basel, University Children’s Hospital Basel and a network of paediatricians and family doctors in the Canton of Basel-City, Switzerland. The retrospective study part includes an analysis of PCR-confirmed influenza cases from 2013 to 2018. The prospective study parts include (1) a household survey regarding influenza-like illness (ILI) and vaccination against influenza during the 2015/2016 season; (2) an analysis of influenza viruses collected during the 2016/2017 season using WGS—viral genomic sequences are compared with determine genetic relatedness and transmissions; and (3) measurement of influenza-specific antibody titres against all vaccinated and circulated strains during the 2016/2017 season from healthy individuals, allowing to monitor herd immunity across urban quarters. Survey data and PCR-confirmed cases are linked to data from the Statistics Office of the Canton Basel-City and visualised using geo-information system mapping. WGS data will be analysed in the context of patient epidemiological data using phylodynamic analyses, and the obtained herd immunity for each quarter. Profound knowledge on the key geographical, epidemiological and immunological factors influencing urban influenza transmission will help to develop effective counter measurements.
The study is registered and approved by the regional ethics committee as an observational study (EKNZ project ID 2015–363 and 2016–01735). It is planned to present the results at conferences and publish the data in scientific journals.
Idiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL). Recently, studies have shown that levamisole, an anthelminthic drug, significantly improves relapse-free survival in children with frequent relapses or steroid dependency. Compared with other steroid-sparing drugs, levamisole has relatively few side effects. We hypothesise that adding levamisole to standard therapy with corticosteroids in children with a first episode of INS will prevent relapses, decrease cumulative dosage of steroids used and improve HRQoL. This paper presents the study protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome).
An international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2–16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week tapering schedule) for a total of 24 weeks. Follow-up will be until 2 years after first presentation. Additionally, parents and/or children will fill out five HRQoL questionnaires. Primary outcome of the LEARNS study is occurrence of relapses within 12 months after first presentation. Secondary outcomes include time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores.
The trial was approved by the Medical Ethical Committee. Results of the study will be published in a peer-reviewed journal.
by Guilherme S. Ferreira, Désirée H. Veening-Griffioen, Wouter P. C. Boon, Ellen H. M. Moors, Christine C. Gispen-de Wied, Huub Schellekens, Peter J. K. van Meer
To gain a deeper understanding of the differences in patients and staff perspectives in response to aggression and to explore recommendations on prevention.
Qualitative, grounded theory study.
We conducted semi‐structured interviews with patients and nurses involved in an aggressive incident. Data collection was performed from May 2016 ‐ March 2017.
Thirty‐one interviews were conducted concerning 15 aggressive incidents. Patients and nurses generally showed agreement on the factual course of events, there was variation in agreement on the perceived severity (PS). Patients' recommendations on prevention were mostly personally focussed, while nurses suggested general improvements.
Patients are often capable to evaluate aggression and give recommendations on prevention shortly after the incident. Patients and nurses differ in the PS of aggression. Recommendations on prevention of patients and nurses are complementary.
What problem did the study address? Perspectives of patients and nurses differ with respect to aggression, but how is unclear. What were the main findings? Patients and nurses generally described a similar factual course of events concerning the incident, patients often perceive the severity less than nurses. Patients are capable to give recommendations on prevention of aggressive incidents, shortly after the incident. Where and on whom will the research have impact? Factual course of events can be a common ground to start evaluating aggressive incidents and post‐incident review should address the severity of incidents. Asking recommendations from patients on how to improve safety and de‐escalation can lead to innovative and personal de‐escalation strategies and supports patients autonomy.
(a) To explore the meanings of master's education in the professionalization of nursing; and (b) to describe the core attributes that nurses gained through master's study.
From June 2017 to June 2018, unstructured interviews were conducted with 12 master‐prepared nurses at advanced nursing position with minimum 5 years of postregistration experience. Collaborative thematic narrative analysis was conducted on verbatim transcripts. Members checking, peer validation and audience validation assured verisimilitude and utility.
There was a need to fit one's own assertion for professional growth in nursing career structure. Master's study equipped nurses with specialty skills and knowledge with enhanced reflexivity, which nurtured morality, problem‐solving ability and capacity to collaborate inter‐professionally. Master‐prepared nurses demonstrated effective clinical leadership through acting as change agents.
Master's level education and master‐prepared nurses are instrumental to the professionalization of nursing by expanding the roles of nurses. Nursing career mentoring will maximize nurses’ agency in healthcare system. Developing innovative inter‐professional pedagogy will nurture the reflexivity of master‐prepared nurses.
To provide insight into the motives for hospital self-referral during office hours and the barriers deterring general practitioner (GP) consultation with a primary care request.
People who self-referred at a Daytime General Practice Cooperative (GPC) in two hospitals in The Hague, The Netherlands.
A total of 44 people who self-referred were interviewed in two hospitals. The average age of interviewees was 35 years (range 19 months to 83 years), a parent of a young patient was interviewed, but the age of patients is shown here. There were more male patients (66%) than female patients (34%). Patients were recruited using a sampling method after triage. Triage was the responsibility of an emergency department (ED) nurse in one hospital and of a GP in the other. Those excluded from participation included (a) children under the age of 18 years and not accompanied by a parent or legal guardian, (b) foreign patients not resident in the Netherlands, (c) patients unable to communicate in Dutch or English and (d) patients directly referred to the ED after triage by the GP (in one hospital).
People who self-referred generally reported several motives for going to the hospital directly. Information and awareness factors played an important role, often related to a lack of information regarding where to go with a medical complaint. Furthermore, many people who self-referred mentioned hospital facilities, convenience and perceived medical necessity as motivational factors. Barriers deterring a visit to the own GP were mainly logistical, including not being registered with a GP, the GP was too far away, poor GP telephone accessibility or a waiting list for an appointment.
Information and awareness factors contribute to misperceptions among people who self-referred concerning the complaint, the GP and the hospital. As a range of motivational factors are involved, there is no straightforward solution. However, better dissemination of information might alleviate misconceptions and contribute to providing the right care to the right patient in the right setting.
Left ventricular diastolic dysfunction (LVDD) is a common condition in both sexes that may deteriorate into heart failure (HF) with preserved ejection fraction (pEF), although this seems to happen more often in women than in men. Both LVDD and HFpEF often go unrecognised, necessitating the discovery of biomarkers that aid both the identification of individuals with LVDD at risk of developing HF and identification of individuals most likely to benefit from treatment.
HELPFul is an ongoing case-cohort study at a Dutch cardiology outpatient clinic enrolling patients aged 45 years and older without history of cardiovascular disease, who were referred by the general practitioner for cardiac evaluation. We included a random sample of patients and enriched the cohort with cases (defined as an E/e’ ≥8 measured with echocardiography). Information about medical history, cardiovascular risk factors, electrocardiography, echocardiography, exercise test performance, common carotid intima-media thickness measurement and standard cardiovascular biomarkers was obtained from the routine care data collected by the cardiology outpatient clinic. Study procedure consists of extensive venous blood collection for biobanking and additional standardised questionnaires. Follow-up will consist of standardised questionnaires by mail and linkage to regional and national registries. We will perform cardiac magnetic resonance imaging and coronary CT angiography in a subgroup of patients to investigate the extent of macrovascular and microvascular coronary disease.
The study protocol was approved by the Institutional Review Board of the University Medical Center Utrecht. Results will be disseminated through national and international conferences and in peer-reviewed journals in cardiovascular disease.
To assess the proportion of Australian children aged 0–15 years that received care in line with clinical practice guidelines (CPGs) for upper respiratory tract infections (URTIs).
Retrospective medical record review using a multistage sampling strategy.
General practices, hospital emergency departments and hospital inpatient service providers in three Australian states.
Children aged up to 15 years who received care for URTI in 2012 and 2013.
The primary assessment was estimated adherence with 14 indicators of appropriate care as documented in medical records. Indicators were extracted from national and international CPGs and ratified by experts. Secondary assessment was adherence to two bundles of indicators (diagnostic symptoms and medical history taking), where all indicators must be adherent for the bundle to be scored as adherent.
There were 1653 children with one or more assessments of URTI care to CPG adherence. Over half of the children were under 3 years of age, with roughly equal numbers of males and females. Three indicators had fewer than 25 visits so were not reported. Overall adherence ranged from 0.5% for ‘documented advice around antibiotics’ to 88.3% for ‘documentation of medical history’. Adherence with Bundle A (documentation of all three definitive symptoms) was 43.1% (95% CI 32.8% to 54.0%) and Bundle B (documentation of all four indicators of medical history) was 30.2% (95% CI 20.9% to 40.9%).
URTIs in children are common, usually self-limiting, conditions that are allocated considerable resources. The results suggest that there may be a need for more thorough holistic assessment of the patient and improved documentation. Since inappropriate prescription of antibiotics for URTIs is still a known problem in Australia, there is a need for consistent, clear communication around antibiotics’ lack of impact on symptoms and a high association with undesirable side effects.
The virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors’ self-efficacy (SE), survivors’ and caregivers’ health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.
A consecutive sample of 384 stroke survivor–caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors’ SE in self-management and survivors’ and caregivers’ HRQoL. Secondary outcomes include survivors’ performance of self-management behaviours, depression and social participation; and caregivers’ coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors’ and caregivers’ satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors’ emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.
The results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.
This protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.
This study examines perceptions of the operational and organisational management of a major outbreak of Middle East Respiratory Syndrome (MERS) caused by a novel coronavirus (MERS-CoV) in the Kingdom of Saudi Arabia (KSA). Perspectives were sought from key decision-makers and clinical staff about the factors perceived to promote and inhibit effective and rapid control of the outbreak.
A large teaching tertiary healthcare centre in KSA; the outbreak lasted 6 weeks from June 2015.
Data were collected via individual and focus group interviews with 28 key informant participants (9 management decision-makers and 19 frontline healthcare workers).
We used qualitative methods of process evaluation to examine perceptions of the outbreak and the factors contributing to, or detracting from successful management. Data were analysed using qualitative thematic content analysis.
Five themes and 15 subthemes were found. The themes were related to: (1) the high stress of the outbreak, (2) factors perceived to contribute to outbreak occurrence, (3) factors perceived to contribute to success of outbreak control, (4) factors inhibiting outbreak control and (5) long-term institutional gains in response to the outbreak management.
Management of the MERS-CoV outbreak at King Abdulaziz Medical City-Riyadh was widely recognised by staff as a serious outbreak of local and national significance. While the outbreak was controlled successfully in 6 weeks, progress in management was inhibited by a lack of institutional readiness to implement infection control (IC) measures and reduce patient flow, low staff morale and high anxiety. Effective management was promoted by greater involvement of all staff in sharing learning and knowledge of the outbreak, developing trust and teamwork and harnessing collective leadership. Future major IC crises could be improved via measures to strengthen these areas, better coordination of media management and proactive staff counselling and support.
To determine the reproducibility of visit-to-visit blood pressure variability (BPV) in clinical practice. We also determined the minimum number of blood pressure (BP) measurements needed to estimate long-term visit-to-visit BPV for predicting 10-year cardiovascular (CV) risk.
A primary care clinic in a university hospital in Malaysia.
Random sampling of 1403 patients aged 30 years and above without any CV event at baseline.
The effect of the number of BP measurement for calculation of long-term visit-to-visit BPV in predicting 10-year CV risk. CV events were defined as fatal and non-fatal coronary heart disease, fatal and non-fatal stroke, heart failure and peripheral vascular disease.
The mean 10-year SD of systolic blood pressure (SBP) for this cohort was 13.8±3.5 mm Hg. The intraclass correlation coefficient (ICC) for the SD of SBP based on the first eight and second eight measurements was 0.38 (p
Long-term visit-to-visit BPV is reproducible in clinical practice. We suggest a minimum of six BP measurements for calculation of intraindividual visit-to-visit BPV. The number and duration of BP readings to derive BPV should be taken into consideration in predicting long-term CV risk.
The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.
To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.
Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.
This study was aimed to evaluate epidemiological and clinical relationship between Mycoplasma pneumoniae (MP) infection and childhood recurrent wheezing episode (RWE).
Retrospective case note review.
Paediatric department at a single Korean institution.
Consecutive admitted patients with MP pneumonia and RWE (0–15 years of age) between 2003 and 2014.
The retrospective medical records of patients with (MP) pneumonia (n=793 for epidemiological analysis and n=501 for clinical analysis) and those with RWE (n=384) from 2003 to 2014 were analysed. Diagnosis of MP pneumonia was made based on two-times titration of IgM antibody during hospitalisation. An RWE patient was defined as one with expiratory wheezing with at least one or more wheezing episodes based on medical records.
During three MP pneumonia epidemics, there were no corresponding increases of patients with RWE in the epidemic years. In the 501 MP pneumonia patients, 52 (10.4%) had wheezing at presentation and 15 (3%) had RWE. The MP pneumonia patients with wheezing at presentation (n=52) were younger and were more likely to have an allergic disease history than those without wheezing (n=449). Among wheezing patients at presentation, 10 patients had previously RWE history. In a follow-up study, 13 patients (including 5 RWE) with initial wheezing and 25 patients (including 2 RWE) without wheezing had wheezy episodes after discharge. Among the total 501 patients, it was estimated that at least 31 MP pneumonia patients (6.2%) showed recurrent wheezing after initial MP infection.
A small part of children with MP pneumonia showed recurrent wheezing after MP pneumonia, and patients with RWE had a greater likelihood of experiencing wheezing when they had an initial MP infection. However, there were no increased admitted patients with RWE in MP pneumonia epidemic periods because of rarity of MP reinfection in children including patients with RWE or asthma.
Multiple systematic reviews have reported on the impact of rib fracture fixation in the presence of flail chest and multiple rib fractures, however this practice remains controversial. Our aim is to synthesise the effectiveness of surgical rib fracture fixation as evidenced by systematic reviews.
A systematic search identified systematic reviews comparing effectiveness of rib fracture fixation with non-operative management of adults with flail chest or unifocal non-flail rib fractures. MEDLINE, EMBASE, Cochrane Database of Systematic Reviews and Science Citation Index were last searched 17 March 2017. Risk of bias was assessed using the Risk Of Bias In Systematic reviews (ROBIS) tool. The primary outcome was duration of mechanical ventilation.
Twelve systematic reviews were included, consisting of 3 unique randomised controlled trials and 19 non-randomised studies. Length of mechanical ventilation was shorter in the fixation group compared with the non–operative group in flail chest; pooled estimates ranged from –4.52 days, 95% CI (–5.54 to –3.5) to –7.5 days, 95% CI (–9.9 to –5.5). Pneumonia, length of hospital and intensive care unit stay all showed a statistically significant improvement in favour of fixation for flail chest; however, all outcomes in favour of fixation had substantial heterogeneity. There was no statistically significant difference between groups in mortality. Two systematic reviews included one non-randomised studies of unifocal non-flail rib fracture population; due to limited evidence the benefits with surgery are uncertain.
Synthesis of the reviews has shown some potential improvement in patient outcomes with flail chest after fixation. For future review updates, meta-analysis for effectiveness may need to take into account indications and timing of surgery as a subgroup analysis to address clinical heterogeneity between primary studies. Further robust evidence is required before conclusions can be drawn of the effectiveness of surgical fixation for flail chest and in particular, unifocal non-flail rib fractures.
China faces the prospect of a large growth in the prevalence of heart failure (HF). However, there is limited knowledge about outcomes in patients after HF hospitalisations, including patient-reported outcomes (PROs). This paper is to present the study goal, methodology and data collection of the China Patient-centred Evaluative Assessment of Cardiac Events Prospective Heart Failure Study (China PEACE 5p-HF Study).
The China PEACE 5p-HF Study, a prospective cohort study, will enrol 5000 patients with HF during 2016–2018 from 52 diverse hospitals throughout China and the follow-up period will be 12 months. Information on patients’ medical history, in-hospital treatment and in-hospital outcomes are being abstracted from medical records. Details of patients’ demographics, socioeconomic status, cardiovascular risk factors, access to healthcare services are being collected through comprehensive baseline interviews. Generic and disease-specific health status, depression, stress, anxiety and cognitive function are being administered using validated PRO instruments. Follow-up interviews will capture PROs and hospitalisation events at 1, 6 and 12 months follow-up. Standardised transthoracic echocardiograms and 6 min walk tests are being done in patients who enrolled in hospitals with these facilities at baseline and at 1 and 12 months after discharge. Collection of blood and urine samples are also being conducted at baseline, 1 and 12 months follow-up and stored for future analyses.
The National Center for Cardiovascular Diseases/Fuwai Hospital ethics committee approved this study, and all collaborating hospitals received approval from their local ethics committee. Written informed consent will be obtained from all patients. Findings will be disseminated in future peer-reviewed papers and will help to support improvements in the quality of care for HF nationwide.
To evaluate the effectiveness of a government-regulated rehabilitation guideline compared with education and activation by general practitioners, and to a preferred-provider insurance-based rehabilitation programme on self-reported global recovery from acute whiplash-associated disorders (WAD) grade I–II.
Pragmatic randomised clinical trial with blinded outcome assessment.
Multidisciplinary rehabilitation clinics and general practitioners in Ontario, Canada.
340 participants with acute WAD grade I and II. Potential participants were sampled from a large automobile insurer when reporting a traffic injury.
Participants were randomised to receive one of three protocols: government-regulated rehabilitation guideline, education and activation by general practitioners or a preferred-provider insurance-based rehabilitation.
Our primary outcome was time to self-reported global recovery. Secondary outcomes included time on insurance benefits, neck pain intensity, whiplash-related disability, health-related quality of life and depressive symptomatology at 6 weeks and 3, 6, 9 and 12 months postinjury.
The median time to self-reported global recovery was 59 days (95% CI 55 to 68) for the government-regulated guideline group, 105 days (95% CI 61 to 126) for the preferred-provider group and 108 days (95% CI 93 to 206) for the general practitioner group; the difference was not statistically significant (X2=3.96; 2 df: p=0.138). We found no clinically important differences between groups in secondary outcomes. Post hoc analysis suggests that the general practitioner (hazard rate ratio (HRR)=0.51, 95% CI 0.34 to 0.77) and preferred-provider groups (HRR=0.67, 95% CI 0.46 to 0.96) had slower recovery than the government-regulated guideline group during the first 80 days postinjury. No major adverse events were reported.
Time-to-recovery did not significantly differ across intervention groups. We found no differences between groups with regard to neck-specific outcomes, depression and health-related quality of life.