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Non-medical determinants of perinatal health: protocol for a systematic review with meta-analysis

Por: Daalderop · L. A. · de Groot · M. W. · van der Meer · L. · Steegers · E. A. P. · Bertens · L. C. M.
Introduction

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).

Methods and analysis

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.

Ethics and dissemination

No ethical approval is necessary for a systematic review with meta-analysis. The findings will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42018056105.

An interrupted time-series analysis of the impact of emergency department reconfiguration on regional emergency department trolley numbers in Ireland from 2005 to 2015

Por: Lynch · B. · Browne · J. · Buckley · C. M. · Healy · O. · Corcoran · P. · Fitzgerald · A. P.
Objectives

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.

Setting

EDs in four Irish regions; the West, North-East, South and Mid-West from 2005 to 2015.

Participants

All patients counted as waiting on trolleys in an ED for a hospital bed in the study hospitals from 2005 to 2015.

Intervention

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.

Results

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

Conclusions

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.

Rates of retention of persons with a mental health disorder in outpatient smoking cessation and reduction trials, and associated factors: protocol for a systematic review and meta-analysis

Por: Metse · A. P. · Stockings · E. · Bailey · J. · Regan · T. · Bartlem · K. · Wolfenden · L. · Taylor · G. · Wiggers · J. · Bowman · J.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

One-year rehospitalisations for congestive heart failure in Portuguese NHS hospitals: a multilevel approach on patterns of use and contributing factors

Por: Moita · B. · Marques · A. P. · Camacho · A. M. · Leao Neves · P. · Santana · R.
Objectives

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.

Setting

All Portuguese mainland National Health Service (NHS) hospitals.

Participants

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.

Outcome measures

We defined 1 year specific heart failure rehospitalisation and time to rehospitalisation as outcome measures.

Results

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.

Conclusions

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.

Patients information needs and attitudes about post-treatment surveillance for colorectal cancer in the United States: a multi-perspective, mixed methods study

Por: Lowenstein · L. M. · Volk · R. J. · Cuddy · A. · Hempstead · A. P. · You · Y. N. · Van Loon · K. · Millas · S. · Meyerhardt · J. A. · Gavin · P. · Chang · G. J.
Objective

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.

Design

A mixed-methods study, using semi-structured interviews followed by a survey study.

Setting

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

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.

Main outcome(s) and measure(s)

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.

Results

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%).

Conclusions

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.

Transplantation of high-risk donor livers after resuscitation and viability assessment using a combined protocol of oxygenated hypothermic, rewarming and normothermic machine perfusion: study protocol for a prospective, single-arm study (DHOPE-COR-NMP tri

Por: de Vries · Y. · Berendsen · T. A. · Fujiyoshi · M. · van den Berg · A. P. · Blokzijl · H. · de Boer · M. T. · van der Heide · F. · de Kleine · R. H. J. · van Leeuwen · O. B. · Matton · A. P. M. · Werner · M. J. M. · Lisman · T. · de Meijer · V. E. · Porte · R.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

This protocol was approved by the medical ethical committee of Groningen, METc2016.281 in August 2016 and registered in the Dutch Trial registration number

Trial registration number

NTR5972, NCT02584283.

Knowledge acquisition and retention following Saving Childrens Lives course for healthcare providers in Botswana: a longitudinal cohort study

Por: Meaney · P. A. · Joyce · C. L. · Setlhare · S. · Smith · H. E. · Mensinger · J. L. · Zhang · B. · Kalenga · K. · Kloeck · D. · Kgosiesele · T. · Jibril · H. · Mazhani · L. · de Caen · A. · Steenhoff · A. P.
Objectives

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.

Setting

76 participating centres who provide primary and secondary care in Kweneng District, Botswana.

Participants

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.

Methods

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.

Results

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

Conclusions

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.

Cognition may link cortical IGFBP5 levels with motor function in older adults

by Aron S. Buchman, Lei Yu, Vladislav A. Petyuk, Chris Gaiteri, Shinya Tasaki, Katherine D. Blizinsky, Julie A. Schneider, Philip L. De Jager, David A. Bennett

Alzheimer’s disease and related disorders (ADRD) may manifest cognitive and non-cognitive phenotypes including motor impairment, suggesting a shared underlying biology. We tested the hypothesis that five cortical proteins identified from a gene network that drives AD and cognitive phenotypes are also related to motor function in the same individuals. We examined 1208 brains of older adults with motor and cognitive assessments prior to death. Cortical proteins were quantified with SRM proteomics and we collected indices of AD and other related pathologies. A higher level of IGFBP5 was associated with poorer motor function proximate to death but AK4, HSPB2, ITPK1 and PLXNB1 were unrelated to motor function. The association of IGFBP5 with motor function was unrelated to the presence of indices of brain pathologies. In contrast, the addition of a term for cognition attenuated the association of IGFBP5 with motor function by about 90% and they were no longer related. These data lend support for the idea that unidentified cortical proteins like IGFBP5, which may not manifest a known pathologic footprint, may contribute to motor and cognitive function in older adults.

A novel topical therapy for resistant and early peristomal pyoderma gangrenosum

Abstract

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.

Pharmacokinetics of oral and subcutaneous meloxicam: Effect on indicators of pain and inflammation after knife castration in weaned beef calves

by Daniela M. Meléndez, Sonia Marti, Edmond A. Pajor, Pritam K. Sidhu, Désirée Gellatly, Eugene D. Janzen, Timothy D. Schwinghamer, Johann F. Coetzee, Karen S. Schwartzkopf-Genswein

Oral meloxicam is labelled for reducing pain and inflammation associated with castration in cattle in Canada, however, subcutaneous meloxicam is only labelled for pain associated with dis-budding and abdominal surgery. The aim of this project was to determine the pharmacokinetic profile of oral (PO; 1.0 mg/kg BW) and subcutaneous meloxicam (SC; 0.5 mg/kg BW), and to assess the effect of meloxicam on physiological and behavioural indicators of pain associated with knife castration in 7–8 month old calves. Twenty-three Angus crossbred beef calves (328 ± 4.4 kg BW) were randomly assigned to two treatments: PO n = 12 or SC n = 11 administration of meloxicam immediately before knife castration. Physiological parameters included salivary and hair cortisol, substance P, haptoglobin, serum amyloid-A, weight, complete blood count, scrotal and rectal temperature. Behavioural parameters included standing and lying behaviour, pen behaviour and feeding behaviour. Data were analyzed using PROC GLIMMIX (SAS), with repeated measures using mixed procedures including treatment as a fixed effect and animal and pen as a random effect. The pharmacokinetic profile of the drug including area under the curve, volume of distribution and clearance was greater (P 0.05) in PO than SC calves. After surgery, substance P concentrations, white blood cell counts (WBC), weight and lying duration were greater (P 0.05) in PO than SC calves, while scrotal circumference was lower (P 0.05) in PO calves than SC calves. Although statistical differences were observed for pharmacokinetic, physiological and behavioural parameters differences were small and may lack biological relevance.

Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial

Por: Hodges · P. · Stafford · R. · Coughlin · G. D. · Kasza · J. · Ashton-Miller · J. · Cameron · A. P. · Connelly · L. · Hall · L. M.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ACTRN12617000788370; Pre-results.

Asparaginase combined with discontinuous dexamethasone improves antileukemic efficacy without increasing osteonecrosis in preclinical models

by Seth E. Karol, Laura J. Janke, John C. Panetta, Laura B. Ramsey, Xiangjun Cai, Monique A. Payton, David A. Jenkins, William E. Evans, Mary V. Relling

Introduction

Combination therapy for acute lymphoblastic leukemia (ALL) is highly effective but results in significant toxicity including osteonecrosis. Asparaginase is known to potentiate both the antileukemic and osteonecrosis-inducing effects of dexamethasone. The schedule of dexamethasone alters osteonecrosis risk. However, the effects of the interaction with asparaginase are unknown when dexamethasone is given on a discontinuous schedule.

Methods

Using the murine model of osteonecrosis, we compared the frequency of osteonecrosis in mice receiving discontinuous dexamethasone (3.5 days/ week) with mice receiving asparaginase and discontinuous dexamethasone. We then tested the effect on antileukemic efficacy using six pediatric ALL xenografts.

Results

The addition of asparaginase to discontinuous dexamethasone did not alter the rate of osteonecrosis compared to dexamethasone alone (7/35 in dexamethasone with asparaginase combination vs. 10/36 in dexamethasone alone, p = 0.62) despite increasing steady-state plasma dexamethasone levels (103.9 nM vs. 33.4 nM, p = 9.2x10-7). Combination therapy with asparaginase and dexamethasone demonstrated synergistic antileukemic effects across all six xenografts studied.

Conclusions

When discontinuous dexamethasone was given, its anti-leukemic activity synergized with asparaginase but the osteonecrosis-worsening effects of asparaginase (above dexamethasone alone) were not observed. Thus, there is a favorable drug interaction (unchanged toxicity, synergistic efficacy) between discontinuous dexamethasone and asparaginase.

Desmopressin treatment combined with clotting factor VIII concentrates in patients with non-severe haemophilia A: protocol for a multicentre single-armed trial, the DAVID study

Por: Schütte · L. M. · Cnossen · M. H. · van Hest · R. M. · Driessens · M. H. E. · Fijnvandraat · K. · Polinder · S. · Beckers · E. A. M. · Coppens · M. · Eikenboom · J. · Laros-van Gorkom · B. A. P. · Meijer · K. · Nieuwenhuizen · L. · Mauser-Bunschoten · E. P. · Leebeek · F. W. G.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NTR5383; Pre-results.

Screening and treatment to reduce severe hyperbilirubinaemia in infants in primary care (STARSHIP): a factorial stepped-wedge cluster randomised controlled trial protocol

Por: van der Geest · B. A. M. · de Graaf · J. P. · Bertens · L. C. M. · Poley · M. J. · Ista · E. · Kornelisse · R. F. · Reiss · I. K. M. · Steegers · E. A. P. · Been · J. V. · STARSHIP study group · Baartmans · Bekhof · Buijs · Bunt · Dijk · Huizer · Hulzebos · Leunissen · Pazur · Snoe
Introduction

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.

Methods and analysis

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).

Ethics and dissemination

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.

Trial registration number

NTR7187.

Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device

Por: Reis · Z. S. N. · Guimaraes · R. N. · Rego · M. A. S. · Maia de Castro Romanelli · R. · Gaspar · J. d. S. · Vitral · G. L. N. · dos Reis · M. A. A. · Colosimo · E. A. · Neves · G. S. · Vale · M. S. · Nader · P. d. J. H. · de Moura · M. D. R. · de Aguiar · R. A. P. L.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.

Trial registration number

RBR-3f5bm5.

Quality of reporting of outcomes in trials of therapeutic interventions for pressure ulcers in adults: a protocol for a systematic survey

Por: Miranda · J. S. · Abbade · L. P. F. · Deonizio · A. P. · Abbade · J. F. · Mbuagbaw · L. · Thabane · L.

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.

Objectives

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.

Methods

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).

Ethics and dissemination

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.

Risk factors associated with premature myocardial infarction: a systematic review protocol

Por: Dugani · S. B. · Ayala Melendez · A. P. · Reka · R. · Hydoub · Y. M. · McCafferty · S. N. · Murad · M. H. · Alsheikh-Ali · A. A. · Mora · S.
Introduction

Premature myocardial infarction (MI) generally refers to MI in men ≤55 years or women ≤65 years. Premature MI is a major contributor to cardiovascular disease (CVD), which claimed 17.6 million lives globally in 2016. Reducing premature MI and CVD is a key priority for all nations; however, there is sparse synthesis of information on risk factors associated with premature MI. To address this knowledge gap, we are conducting a systematic review to describe the association between risk factors (demographics, lifestyle factors and biomarkers) and premature MI.

Methods and analysis

The following databases were searched from inception to June 2018: CENTRAL, CINAHL, Clinical Trials, EMBASE and MEDLINE. We will include original research articles (case–control, cohort and cross-sectional studies) that report a quantitative relationship between at least one risk factor and premature MI. Two investigators will use predetermined selection criteria and independently screen articles based on title and abstract (primary screening). Articles that meet selection criteria will undergo full-text screening based on criteria used for primary screening (secondary screening). Data will be extracted using predetermined data extraction forms. The Newcastle-Ottawa Scale for case–control and cohort studies will be used to evaluate the risk of bias and will be adapted for cross-sectional studies. Whenever feasible, data will be summarised into a random-effects meta-analysis.

Ethics and dissemination

To our knowledge, this will be the first study to synthesise results on the relationship between risk factors and premature MI. These findings will inform healthcare providers on factors associated with risk of premature MI and potentially improve primary prevention efforts by guiding development of interventions. These findings will be summarised and presented at conferences and through publication in a peer-reviewed journal.

PROSPERO registration number

CRD42018076862.

Family Violence Curricula in Europe (FAVICUE): a cross-sectional descriptive study protocol

Por: Gomez Bravo · R. · Lygidakis · C. · Feder · G. · Reuter · R. A. P. · Vögele · C.
Introduction

Family violence (FV) is a widespread public health problem of epidemic proportions and serious consequences. Doctors may be the first or only point of contact for victims who may be hesitant or unable to seek other sources of assistance, and they tend not to disclose abuse to doctors if not specifically asked. A comprehensive healthcare response is key to a coordinated community-wide approach to FV, but most of the practising physicians have received either no or insufficient education or training in any aspect of FV. Training of medical students concerning FV is often delivered in an inconsistent or ad hoc manner.

The main aim of this project, Family Violence Curricula in Europe (FAVICUE), is to (1) describe current FV education delivery in European medical universities (undergraduate period) and during the specialist training in general practice (GP)/family medicine (FM) (postgraduate residency programme), and (2) compare it with WHO recommendations for FV curriculum.

Methods and analysis

This is the protocol of a cross-sectional descriptive study consisting of two self-report online surveys (for undergraduate and postgraduate training, respectively) with 40 questions each. For both surveys, general practitioners, residents, medical students and professionals involved in their education from countries of the European region will be identified through the European Regional Branch of the World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA Europe) and will be invited to provide information regarding the training on FV. Descriptive tests will be carried out and a thematic analysis will be conducted on the open-ended questions.

Ethics and dissemination

Ethics approval has been obtained by the University of Luxembourg (ERP 17–015 FAVICUE). The results will provide important information concerning current curricula on FV, and can be used for mapping the educational needs and planning the implementation of future training interventions. They will be published and disseminated through WONCA Europe and its networks.

Comparison of two bovine serum pregnancy tests in detection of artificial insemination pregnancies and pregnancy loss in beef cattle

by Emmalee J. Northrop, Jerica J. J. Rich, Jim R. Rhoades, George A. Perry

Blood tests for early detection of pregnancy in cattle based on pregnancy-associated glycoproteins (PAGs) are commercially available. The objective of these studies were to compare the accuracy of blood tests to transrectal ultrasonography in detecting AI pregnancies, and to compare the accuracy of blood tests in predicting pregnancy loss. Beef cattle from 6 herds were synchronized using a recommended CIDR based protocol (Study 1: n = 460; Study 2: n = 472). Pregnancy status was determined by transrectal ultrasonography between days 28–40 following AI, blood samples were collected at this time. In study 2 a final pregnancy determination was performed at the end of the breeding season to determine pregnancy loss. Each serum sample was examined for PAG concentrations using a microtiter plate reader and/or scored by two technicians blind to pregnancy status and pregnancy loss. For study 1 Cohen’s kappa statistics were calculated to assess the agreement between each test and transrectal ultrasonography. For study 2 data was analyzed using the GLIMMIX procedure of SAS with herd as a random effect, and loss, age, and their interaction included in the model. Agreement was good to very good for each test. There was no difference (P = 0.79) in sensitivity, but a difference (PP = 0.04), age (P = 0.0002), and their interaction (P = 0.06) on PAG concentrations. In conclusion both pregnancy tests were accurate at detecting AI pregnancies, and were in very good agreement with transrectal ultrasonography. Both tests detected differences in PAGs among females that maintained and lost pregnancy; however, prediction proved to be difficult as most females were above the threshold and would have been considered pregnant on the day of testing.

Cross-sectional research conducted in the Netherlands to identify relationships among the actual level of patient-centred care, the care gap (ideal vs actual care delivery) and satisfaction with care

Por: Mirzad · F. · Cramm · J. M. · Nieboer · A. P.
Objective

This study aimed to identify relationships among the actual level of patient-centred care (PCC), the care gap (ideal level of PCC vs actual care delivery) and satisfaction with care.

Design

This study was a cross-sectional survey.

Setting

This study was conducted at two locations of a Dutch hospital (Nieuwegein and Leidsche Rijn Utrecht).

Participants

Patients visiting the outpatient clinics for heart failure, chronic obstructive pulmonary disease (COPD) and cancer in March–May 2017 were asked to fill in a questionnaire. Inclusion criteria were diagnosis with COPD, heart failure or cancer and clinic visitation for a regular appointment. A total of 186 patients filled in the questionnaire.

Primary and secondary outcome measures

Outcomes evaluated were the actual level of PCC, the care gap and satisfaction with care.

Results

About half (45%) of the respondents were female, 38% had low educational levels and 31% were single. Respondents’ mean age was 67.83 ± 10.02 (range, 16–94) years. Patients’ experiences with actual care delivery and their conceptualisation of the ideal type of care differed significantly, representing care gaps, in all PCC dimensions. After controlling for background characteristics, patients’ experiences with actual delivery and the care gap were related significantly to patients’ satisfaction with care (β = 0.17 and β = – 0.41, respectively).

Conclusions

Patients’ experiences with the actual level of PCC and the care gap are important for patients’ satisfaction with care.

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