by F. A. Abade dos Santos, M. Monteiro, A. Pinto, C. L. Carvalho, M. C. Peleteiro, P. Carvalho, P. Mendonça, T. Carvalho, M. D. DuarteDuring the necropsies of Iberian hares obtained in 2018/2019, along with signs of the nodular form of myxomatosis, other unexpected external lesions were also observed. Histopathology revealed nuclear inclusion bodies in stromal cells suggesting the additional presence of a nuclear replicating virus. Transmission electron microscopy further demonstrated the presence of herpesvirus particles in the tissues of affected hares. We confirmed the presence of herpesvirus in 13 MYXV-positive hares by PCR and sequencing analysis. Herpesvirus-DNA was also detected in seven healthy hares, suggesting its asymptomatic circulation. Phylogenetic analysis based on concatenated partial sequences of DNA polymerase gene and glycoprotein B gene enabled greater resolution than analysing the sequences individually. The hare’ virus was classified close to herpesviruses from rodents within the Rhadinovirus genus of the gammaherpesvirus subfamily. We propose to name this new virus Leporid gammaherpesvirus 5 (LeHV-5), according to the International Committee on Taxonomy of Viruses standards. The impact of herpesvirus infection on the reproduction and mortality of the Iberian hare is yet unknown but may aggravate the decline of wild populations caused by the recently emerged natural recombinant myxoma virus.
A relevant subsample of patients with chronic low back pain (CLBP) have manifested augmented central pain processing, central sensitisation (CS). Patients with CLBP have limited functioning and participation. Theoretically, physical functioning in patients with CLBP can plausibly be linked to CS; however, evidence to explain such association is scarce. Moreover, there is no gold standard for CS diagnosis. The objectives of the study are: (1) to analyse the association between instruments assessing reference symptoms and signs attributed to CS; (2) to analyse whether reference symptoms and signs attributed to CS are associated with functioning measurement outcomes; and (3) to analyse whether changes (between baseline and discharge) in reference symptoms and signs attributed to CS are related to changes in each of the functioning measurement outcomes.
A cross-sectional and longitudinal observational study is performed with measurements taken at baseline and discharge of an interdisciplinary rehabilitation programme. A sample size of 110 adult patients with CLBP has been calculated for the study. CS measurements are: Central Sensitisation Inventory, quantitative sensory testing and heart rate variability. Functioning measurements are: lifting capacity, maximal aerobic capacity, accelerometry and reported functioning. Statistical analyses to be performed are: (1) correlation between CS measurements, (2) multiple regression between functioning (dependent variable) and CS measurements (independent variable), and (3) multiple regression between changes in scores of functioning (dependent variable) and CS measurements (independent variable), and corrected for sex and age.
The study obtained the clearance to its implementation from the Medical Research Ethics Committee of the University Medical Center Groningen in July 2017. The results will be disseminated through scientific publications in peer-reviewed journals, presentations at relevant conferences, and reports to stakeholders.
by Linda L. Jagodzinski, Mark M. Manak, Holly R. Hack, Ying Liu, Sheila A. PeelManagement of Human Immunodeficiency Virus Type 2 (HIV-2) infections present unique challenges due to low viral titers, slow disease progression, and poor response to standard antiviral therapies. The need for a nucleic acid assay to detect and quantify HIV-2 virus has led to the development of a number of molecular-based assays for detection and/or quantification of HIV-2 viral RNA in plasma in order to provide laboratory evidence of HIV-2 infection and viral loads for use in treatment decisions. As HIV-2 is less pathogenic and transmissible than HIV-1 and has resistance to several of the antiretroviral drugs, delay of treatment is common. Cross sero-reactivity between HIV-1 and HIV-2 makes it difficult to distinguish between the two viruses based upon serological tests. As such we developed a quantitative reverse transcription PCR (qRT-PCR) assay targeting the 5’ long terminal repeat of HIV-2 for detection and quantification of HIV-2 viral RNA in plasma to identify HIV-2 infection and for use in viral load monitoring. Serial dilutions of cultured HIV-2 virus demonstrated a wide dynamic range (10 to 100,000 copies/ml) with excellent reproducibility (standard deviation from 0.12–0.19), linearity (R2 = 0.9994), and a lower limit of detection at 79 copies/ml (NIH-Z). The assay is highly specific for HIV-2 Groups A and B and exhibits no cross reactivity to HIV-1, HBV or HCV. Precision of the assay was demonstrated for the High (Mean = 6.41; SD = 0.12) and Medium (Mean = 4.46; SD = 0.13) HIV-2 positive controls. Replicate testing of clinical specimens showed good reproducibility above 1,000 copies/ml, with higher variability under 1,000 copies/ml. Analysis of 220 plasma samples from HIV-2 infected West African individuals demonstrated significantly lower viral loads than those observed in HIV-1 infections, consistent with results of previous studies. Slightly more than seven percent of clinical samples (7.3%) demonstrated viral loads above 100,000 copies/ml, while 37.3% of samples were undetectable. The high sensitivity, specificity, precision, and linearity of the WRAIR qRT-PCR assay makes it well suited for detection and monitoring of HIV-2 RNA levels in plasma of infected individuals.
Nursing home (NH) residents experience a high burden of chronic disease. Chronic disease management (CDM) can be a challenge, as the context of care provision and the way care is provided impact care delivery. This scoping review aimed to identify types of chronic diseases studied in intervention studies in NHs, influential contextual factors addressed by interventions and future CDM research considerations.
The scoping review followed guidelines by Arksey and O’Malley (2005) and Levac, Colquhoun and O’Brien (2010). Six reviewers screened citations for inclusion. Data extraction was performed by one reviewer and verified by a second reviewer.
We searched four databases: CINAHL, EMBASE, PubMed and Scopus, in March 2018.
Studies were included if (1) aim of intervention was to improve CDM, (2) intervention incorporated the chronic care model (CCM), (3) included NH residents, (4) analysed the efficacy of the intervention and (5) sample included adults over age 65 years. Studies were limited to English or French language and to those published after 1996, when the CCM was first conceptualised.
Extracted information included the type of chronic disease, the type and number of CCM model components used in the intervention, the method of delivery of the intervention, and outcomes.
On completion of the review of 11 917 citations, 13 studies were included. Most interventions targeted residents living with dementia. There was significant heterogeneity noted among designs, outcomes, and type and complexity of intervention components. There was little evaluation of the sustainability of interventions, including feasibility.
Research was heavily focused on management of dementia. The most commonly included CCM components were multidisciplinary care, evidence-based care, coordinated care and clinical information systems. Future research should include subjective and objective outcomes, which are meaningful for NH residents, for common chronic diseases.
Commentary on: Irigoyen M, Segovia AP, Galván L, et al. Predictors of re-attempt in a cohort of suicide attempters: a survival analysis. J Affect Disord. 2019 Mar 15;247:20-28. doi: 10.1016/j.jad.2018.12.050. Epub 18 Dec 2018.
Further exploration is needed within the time period of 1–6 months following a suicide attempt to analyse the support required to identify reattempters. Further research is required to examine the impact and effectiveness of psychological interventions on suicide attempters. Does this help to reduce suicide reattempts more than pharmacological interventions?
Further exploration is needed within the time period of 1–6 months following a suicide attempt to analyse the support required to identify reattempters.
Further research is required to examine the impact and effectiveness of psychological interventions on suicide attempters. Does this help to reduce suicide reattempts more than pharmacological interventions?
Suicide is a global priority.
To investigate palliative care nurse attitudes towards medical assistance in dying.
An exploratory cross‐sectional study design.
A mailed letter recruited participants with data collection occurring on a secure online survey platform between November 2017‐February 2018. Data analyses included descriptive and bivariate statistics and stepwise linear regression.
Palliative care nurse attitudes towards medical assistance in dying were explained by perceived expertise in the social domain of palliative care, personal importance of religion/faith, professional importance of religion/faith, and nursing designation.
This study reveals the perceived importance of religion, versus religious affiliation alone, as significant in influencing provider attitudes towards assisted dying. Further research is needed to understand differences in attitudes between Registered Nurses and Registered Practical Nurses and how the social domain of palliative care influences nurse attitude.
Organizations must prioritize nursing input, encourage open interprofessional dialogue and provide support for ethical decision‐making, practice decisions, and conscientious objection surrounding medical assistance in dying. Longitudinal nursing studies are needed to understand the impact of legislation on quality and person‐centred end‐of‐life care and the emotional well‐being/retention of palliative care nurses.
Community paramedicine programme are often designed to address repeated and non-urgent use of paramedic services by providing patients with alternatives to the traditional ‘treat and transport’ ambulance model of care. We sought to investigate the level of consensus that could be found by a panel of experts regarding appropriate health, social and environmental domains that should be assessed in community paramedicine home visit programme.
We applied the RAND/UCLA Appropriateness Method in a modified Delphi method to investigate the level of consensus on assessment domains for use in community paramedicine home visit programme.
We included a multi-national panel of 17 experts on community paramedicine and in-home assessment from multiple settings (paramedicine, primary care, mental health, home and community care, geriatric care).
A list of potential assessment categories was established after a targeted literature review and confirmed by panel members. Over multiple rounds, panel members scored the appropriateness of 48 assessment domains on a Likert scale from 0 (not appropriate) to 5 (very appropriate). Scores were then reviewed at an in-person meeting and a finalised list of assessment domains was generated.
After the preliminary round of scoring, all 48 assessment domains had scores that demonstrated consensus. Nine assessment domains (18.8%) demonstrated a wider range of rated appropriateness. No domains were found to be not appropriate. Achieving consensus about the appropriateness of assessment domains on the first round of scoring negated the need for subsequent rounds of scoring. The in-person meeting resulted in re-grouping assessment domains and adding an additional domain about urinary continence.
An international panel of experts with knowledge about in-home assessment by community paramedics demonstrated a high level of agreement on appropriate patient assessment domains for community paramedicine home visit programme. Community paramedicine home visit programme are likely to have similar patient populations. A standardised assessment instrument may be viable in multiple settings.
Research focusing on the associations between non-medical determinants and unfavourable perinatal health outcomes is increasing. Despite increasing knowledge on this theme, it still remains unclear to what extent social, environmental and lifestyle factors contribute to these unfavourable outcomes. Therefore, we aim to provide a systematic review, preferably with meta-analysis, in order to provide insight into the associations between non-medical determinants and perinatal mortality, preterm birth and being small for gestational age (SGA).
Observational studies performed in European countries studying the associations between non-medical determinants and unfavourable perinatal health outcomes will be included. Primary outcomes of interest are perinatal mortality, preterm birth and SGA. To retrieve potential eligible articles, a systematic literature search was performed in the following online databases on 5 October 2018: MEDLINE, Embase, Web of Science, Cochrane and Google Scholar. Additionally, a reference list check and citation search will be performed. Data of the included articles will be extracted using a standardised and piloted data extraction form. Risk of bias will be assessed using the Newcastle-Ottawa Scale. The study selection and data extraction process will be performed by two reviewers independently. Disagreements will be resolved through discussion with a third reviewer. The pooled effects will be calculated separately for each association found between one of the outcome measures and the non-medical determinants using a random effects model. Heterogeneity of the studies will be assessed using the I2 statistic.
No ethical approval is necessary for a systematic review with meta-analysis. The findings will be published in a peer-reviewed journal.
To understand the impact of emergency department (ED) reconfiguration on the number of patients waiting for hospital beds on trolleys in the remaining EDs in four geographical regions in Ireland using time-series analysis.
EDs in four Irish regions; the West, North-East, South and Mid-West from 2005 to 2015.
All patients counted as waiting on trolleys in an ED for a hospital bed in the study hospitals from 2005 to 2015.
The system intervention was the reconfiguration of ED services, as determined by the Department of Health and Health Service Executive. The timing of these interventions varied depending on the hospital and region in question.
Three of the four regions studied experienced a significant change in ED trolley numbers in the 12-month post-ED reconfiguration. The trend ratio before and after the intervention for these regions was as follows: North-East incidence rate ratio (IRR) 2.85 (95% CI 2.04 to 3.99, p
Findings suggest that the impacts of ED reconfiguration on regional level ED trolley trends were either non-significant or caused a short-term shock which converged on the pre-reconfiguration trend over the following 12 months. However, the North-East is identified as an exception due to increased pressures in one regional hospital, which caused a change in trend beyond the 12-month post reconfiguration.
Smoking among persons with a mental health disorder is associated with inequitable health, social and economic burden. Randomised controlled trials (RCTs) are considered the gold standard design for the assessment of healthcare intervention efficacy/effectiveness. However, many RCTs of smoking interventions for persons with a mental health disorder lack rigour due to low participant retention. No systematic review has pooled retention rates in randomised trials of smoking interventions for persons with a mental health disorder or explored associated factors. The aims of the systematic review will therefore be to: (1) summarise overall rates of participant retention in smoking cessation and reduction trials involving persons with a mental health disorder (including for experimental and control groups separately) and (2) determine if retention rates vary according to participant, environmental, researcher and study factors.
PsycINFO, EMBASE, MEDLINE, CENTRAL and The Cochrane Tobacco Addiction Review Group Specialised Register will be searched for reports of RCTs of outpatient smoking cessation or reduction interventions for adults with a mental health disorder. The search terms will include MeSH terms and free text words, and there will be no language or date restrictions. All databases will be searched from inception to present. Data will be analysed using the Mantel-Haenszel fixed-effect model, and where substantial heterogeneity (I2 >50%) is detected, DerSimonian & Laird inverse-variance random effects model. Pooled estimates and 95% CIs will be calculated for overall participant retention rates and for intervention and control trial arms separately. Associations between participant retention and participant, environmental, researcher and study factors will be assessed via subgroup analyses and, where sufficient data are obtained, meta-regression.
This study does not require ethical approval. The findings of this review will be disseminated via publication in a peer-reviewed open access medical journal and presentations at international scientific meetings.
Identification of rehospitalisations for heart failure and contributing factors flags health policy intervention opportunities designed to deliver care at a most effective and efficient level. Recognising that heart failure is a condition for which timely and appropriate outpatient care can potentially prevent the use of inpatient services, we aimed to determine to what extent comorbidities and material deprivation were predictive of 1 year heart failure specific rehospitalisation.
All Portuguese mainland National Health Service (NHS) hospitals.
A total of 68 565 hospitalisations for heart failure principal cause of admission, from 2011 to 2015, associated to 45 882 distinct patients aged 18 years old or over.
We defined 1 year specific heart failure rehospitalisation and time to rehospitalisation as outcome measures.
Heart failure principal diagnosis admissions accounted for 1.6% of total hospital NHS budget, and over 40% of this burden is associated to patients rehospitalised at least once in the 365-day follow-up period. 22.1% of the patients hospitalised for a principal diagnosis of heart failure were rehospitalised for the same cause at least once within 365 days after previous discharge. Nearly 55% of rehospitalised patients were readmitted within 3 months. Results suggest a mediation effect between material deprivation and the chance of 1 year rehospitalisation through the effect that material deprivation has on the prevalence of comorbidities. Heart failure combined with chronic kidney disease or chronic obstructive pulmonary disease increases by 2.8 and 2.2 times, respectively, the chance of the patient becoming a frequent user of inpatient services for heart failure principal cause of admission.
One-fifth of patients admitted for heart failure are rehospitalised due to heart failure exacerbation. While the role of material deprivation remained unclear, comorbidities considered increased the chance of 1 year heart failure specific rehospitalisation, in particular, chronic kidney disease and chronic obstructive pulmonary disease.
We sought to determine patients’ informational needs for post-treatment surveillance and elicit clinicians’ and patient advocates’ (ie, stakeholders) opinions regarding what patients should know about post-treatment surveillance in the USA.
A mixed-methods study, using semi-structured interviews followed by a survey study.
Participants for the interviews were from two large academic medical centres and a safety-net hospital. The stakeholders were recruited from attendees at the Alliance for Clinical Trials in Oncology Network Spring 2016 meeting.
Participants for the in-depth interviews were purposively sampled. Eligible patients were 6 months to 5 years post curative resection for colorectal cancer and were fluent in English. Participants for the anonymous survey were stakeholders.
The main outcome was patients’ with colorectal cancer informational needs for post-treatment surveillance, using an interview guide. The second outcome was the importance of the identified informational needs using an anonymous survey.
Of the 67 patients approached, 31 were interviewed (response rate=46%), the majority were between 1 and 3 years post-treatment (81%) and diagnosed at stage III (74%). Despite a desire to monitor for cancer recurrence, patients had little understanding of the concept of post-treatment surveillance, equating surveillance with screening and a belief that if a recurrence was found early there would be a higher likelihood of cure. The survey suggested that clinicians (n=38) and patient advocates (n=11) had some differing opinions regarding what patients should know about surveillance to be active in decisions. For example, compared with clinicians, patient advocates felt that patients should know recurrence treatment options (100% vs 58%) and likelihood for cure following recurrence treatment (100% vs 38%).
The results of this exploratory mixed-methods study suggest that novel educational interventions targeting both patients and clinicians are needed to address the informational needs for post-treatment surveillance of colorectal cancer.
Extended criteria donor (ECD) livers are increasingly accepted for transplantation in an attempt to reduce the gap between the number of patients on the waiting list and the available number of donor livers. ECD livers; however, carry an increased risk of developing primary non-function (PNF), early allograft dysfunction (EAD) or post-transplant cholangiopathy. Ischaemia-reperfusion injury (IRI) plays an important role in the development of these complications. Machine perfusion reduces IRI and allows for reconditioning and subsequent evaluation of liver grafts. Single or dual hypothermic oxygenated machine perfusion (DHOPE) (4°C–12°C) decreases IRI by resuscitation of mitochondria. Controlled oxygenated rewarming (COR) may further reduce IRI by preventing sudden temperature shifts. Subsequent normothermic machine perfusion (NMP) (37°C) allows for ex situ viability assessment to facilitate the selection of ECD livers with a low risk of PNF, EAD or post-transplant cholangiopathy.
This prospective, single-arm study is designed to resuscitate and evaluate initially nationwide declined ECD livers. End-ischaemic DHOPE will be performed for the initial mitochondrial and graft resuscitation, followed by COR of the donor liver to a normothermic temperature. Subsequently, NMP will be continued to assess viability of the liver. Transplantation into eligible recipients will proceed if all predetermined viability criteria are met within the first 150 min of NMP. To facilitate machine perfusion at different temperatures, a perfusion solution containing a haemoglobin-based oxygen carrier will be used. With this protocol, we aim to transplant extra livers. The primary endpoint is graft survival at 3 months after transplantation.
This protocol was approved by the medical ethical committee of Groningen, METc2016.281 in August 2016 and registered in the Dutch Trial registration number
Millions of children die every year from serious childhood illnesses. Most deaths are avertable with access to quality care. Saving Children’s Lives (SCL) includes an abbreviated high-intensity training (SCL-aHIT) for providers who treat serious childhood illnesses. The objective of this study was to examine the impact of SCL-aHIT on knowledge acquisition and retention of providers.
76 participating centres who provide primary and secondary care in Kweneng District, Botswana.
Doctors and nurses expected by the District Health Management Team to provide initial care to seriously ill children, completed SCL-aHIT between January 2014 and December 2016, submitted demographic data, course characteristics and at least one knowledge assessment.
Retrospective, cohort study. Planned and actual primary outcome was adjusted acquisition (change in total knowledge score immediately after training) and retention (change in score at 1, 3 and 6 months), secondary outcomes were pneumonia and dehydration subscores. Descriptive statistics and linear mixed models with random intercept and slope were conducted. Relevant institutional review boards approved this study.
211 providers had data for analysis. Cohort was 91% nurses, 61% clinic/health postbased and 45% pretrained in Integrated Management of Childhood Illness (IMCI). A strong effect of SCL-aHIT was seen with knowledge acquisition (+24.56±1.94, p
aHIT for care of the seriously ill child significantly increased provider knowledge and loss of knowledge occurred over time. IMCI training did not significantly impact overall knowledge acquisition nor retention, while professional status impacted overall score and lost to follow-up impacted retention.
Peristomal pyoderma gangrenosum (PPG) is an under‐recognised and difficult condition to treat. We describe a case series using a novel topical combination therapy that promotes wound healing and allows for adhesion of the stoma appliance. A crushed oral prednisolone tablet mixed with Stomahesive Protective Powder (ConvaTec) was applied topically to seven patients with PPG and resulted in pain relief and wound healing in six of seven patients. Only one patient experienced recurrence. The novel topical therapy we describe is cost‐effective, readily available, and easily applied in any inpatient or outpatient setting.
Prostate cancer is the most common cancer in men. Prostatectomy is the most common treatment. Morbidity from prostatectomy is high—80% of men experience urinary incontinence which negatively impacts the quality of life. Postsurgical pelvic floor muscle training is commonly prescribed but recent systematic reviews found no evidence of efficacy. We propose a new treatment that commences preoperatively and targets functional training of specific pelvic floor muscles that contribute to urinary continence. Assessment and biofeedback using transperineal ultrasound imaging assists in training. This will be compared against conventional training (maximal pelvic floor muscle contraction assessed by digital rectal examination) and no training. Embedded physiological studies will allow the investigation of moderation and mediation of the treatment effect on the outcomes.
This randomised clinical trial will include 363 men scheduled to undergo radical prostatectomy for prostate cancer. Participants will be randomised into urethral training, conventional training and no training groups. Clinical data will be collected at baseline (1–2 weeks presurgery) and postsurgery after catheter removal, weekly to 3 months (primary endpoint) and monthly to 12 months. Outcomes include 24-hour pad weight test (primary), incontinence, quality of life and cost-effectiveness data. Neuromuscular control measures of pelvic floor muscles will be measured at baseline, postsurgery, 6 weeks, 3 and 12 months. Study assessors and statisticians will be blinded to the group allocation.
This study is registered with the Australian New Zealand Clinical Trials Registry and has ethical approval from the university and host hospital ethics committees. Trial outcomes will be shared via national/international conference presentations and peer-reviewed journal publications.
Haemophilia A is an inherited bleeding disorder characterised by factor VIII (FVIII) deficiency. In patients with non-severe haemophilia A, surgery and bleeding are the main indications for treatment with FVIII concentrate. A recent study reported that standard dosing frequently results in FVIII levels (FVIII:C) below or above FVIII target ranges, leading to respectively a bleeding risk or excessive costs. In addition, FVIII concentrate treatment carries a risk of development of neutralising antibodies. An alternative is desmopressin, which releases endogenous FVIII and von Willebrand factor. In most patients with non-severe haemophilia A, desmopressin alone is not enough to achieve FVIII target levels during surgery or bleeding. We hypothesise that combined pharmacokinetic (PK)-guided administration of desmopressin and FVIII concentrate may improve dosing accuracy and reduces FVIII concentrate consumption.
In the DAVID study, 50 patients with non-severe haemophilia A (FVIII:C ≥0.01 IU/mL) with a bleeding episode or undergoing surgery will receive desmopressin and FVIII concentrate combination treatment. The necessary dose of FVIII concentrate to reach FVIII target levels after desmopressin administration will be calculated with a population PK model. The primary endpoint is the proportion of patients reaching FVIII target levels during the first 72 hours after start of the combination treatment. This approach was successfully tested in one pilot patient who received perioperative combination treatment.
The DAVID study was approved by the medical ethics committee of the Erasmus MC. Results of the study will be communicated trough publication in international scientific journals and presentation at (inter)national conferences.
Jaundice caused by hyperbilirubinaemia is a physiological phenomenon in the neonatal period. However, severe hyperbilirubinaemia, when left untreated, may cause kernicterus, a severe condition resulting in lifelong neurological disabilities. Although commonly applied, visual inspection is ineffective in identifying severe hyperbilirubinaemia. We aim to investigate whether among babies cared for in primary care: (1) transcutaneous bilirubin (TcB) screening can help reduce severe hyperbilirubinaemia and (2) primary care-based (versus hospital-based) phototherapy can help reduce hospital admissions.
A factorial stepped-wedge cluster randomised controlled trial will be conducted in seven Dutch primary care birth centres (PCBC). Neonates born after 35 weeks of gestation and cared for at a participating PCBC for at least 2 days within the first week of life are eligible, provided they have not received phototherapy before. According to the stepped-wedge design, following a phase of ‘usual care’ (visual assessment and selective total serum bilirubin (TSB) quantification), either daily TcB measurement or, if indicated, phototherapy in the PCBC will be implemented (phase II). In phase III, both interventions will be evaluated in each PCBC. We aim to include 5500 neonates over 3 years.
Primary outcomes are assessed at 14 days of life: (1) the proportion of neonates having experienced severe hyperbilirubinaemia (for the TcB screening intervention), defined as a TSB above the mean of the phototherapy and the exchange transfusion threshold and (2) the proportion of neonates having required hospital admission for hyperbilirubinaemia treatment (for the phototherapy intervention in primary care).
This study has been approved by the Medical Research Ethics Committee of the Erasmus MC Rotterdam, the Netherlands (MEC-2017-473). Written parental informed consent will be obtained. Results from this study will be published in peer-reviewed journals and presented at (inter)national meetings.
Recognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.
Research protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.
Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.
Pressure ulcers (PUs) have a high incidence, especially in hospital units. Randomised clinical trials (RCTs) of therapeutic interventions for PU should include a clear description of the outcomes and results to enhance transparency and replicability.
The primary objective of this study is to assess the completeness of the descriptions of the outcomes of therapeutic interventions in RCTs in adult patients with PU. The secondary objectives are to evaluate the types of reported primary outcomes, measurement methods or tools used to evaluate the outcomes and the results of reported outcomes.
We will conduct a systematic survey of RCTs published from January 2006 to April 2018. The selection process of the studies will be done in two stages of screening: title and abstract, and full text revision, always by two researchers independently. The completeness of the outcome will be assessed according to five criteria: domain (outcome title), specific measurement or technique/instrument used, specific metric or format of the outcome data that will be used for analysis, method of aggregation (how data from each group will be summarised) and time-points that will be used for analysis. The quality of the results of the outcome will be classified as either complete, incomplete or unreported. We will conduct a descriptive analysis of the number, type and degrees of outcome specification in the included RCTs. The frequency of categories in each domain of the outcomes will also be reported. The median and IQR will be estimated for each element of the specified outcome (out of five).
This will be the first systematic assessment of the outcomes of therapeutic interventions used for pressure ulcers. After completion, this review will be submitted to a peer-reviewed journals.