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Contaminantes en la alimentación infantil. Revisión bibliográfica

Objetivo principal: Actualizar el conocimiento actual existente sobre contaminantes en alimentos y productos elaborados específicamente para la población infantil. Metodología: Se realizó una revisión bibliográfica de los artículos disponibles publicados hasta marzo de 2019, en las siguientes bases de datos bibliográficas: PubMed, Scopus y Web of Science. Resultados principales: Son múltiples los contaminantes en los alimentos de consumo infantil, destacando entre ellos los metales pesados, micotoxinas, ftalatos, bisfenol A (BPA), contaminantes orgánicos persistentes (PCBs), contaminantes microbiológicos y metilmercurio, entre otros. Conclusión principal: Se necesitan datos adicionales que analicen la exposición y efec-tos del consumo de dichos contaminantes para la evaluación de riesgos y la distribución de las principales fuentes de contaminación.

Detection of <i>MYD88 L265P</i> mutation by next-generation deep sequencing in peripheral blood mononuclear cells of Waldenström’s macroglobulinemia and IgM monoclonal gammopathy of undetermined significance

by Ayako Nakamura, Chikako Ohwada, Masahiro Takeuchi, Yusuke Takeda, Shokichi Tsukamoto, Naoya Mimura, Oshima-Hasegawa Nagisa, Yasumasa Sugita, Hiroaki Tanaka, Hisashi Wakita, Nobuyuki Aotsuka, Kosei Matsue, Koutaro Yokote, Osamu Ohara, Chiaki Nakaseko, Emiko Sakaida

We investigated the feasibility of using next-generation sequencing (NGS) technique using molecular barcoding technology to detect MYD88 L265P mutation in unselected peripheral blood mononuclear cells (PBMCs) in 52 patients with Waldenström’s macroglobulinemia [1] and 21 patients with IgM-monoclonal gammopathy of undetermined significance (MGUS). The NGS technique successfully detected the MYD88 L265P in unselected PBMCs at a sensitivity of 0.02%, which was ×5 higher than that of AS-PCR. All the results between paired BM and PB samples from 2 IgM MGUS and 4 untreated WM patients matched completely. MYD88 L265P mutation was detected in 14/21 (66.7%), 14/19 (73.7%), and 10/33 (30.3%) with the median mutant allele burden of 0.36% (range, 0.06–2.85%), 0.48% (range, 0.02–32.3%), and 0.16% (range, 0.02–33.8%), in IgM-MGUS, untreated WM, and previously treated WM, respectively. Multiple linear regression analysis identified an absolute peripheral lymphocyte count as the positive predictor of PB mutant allele burden (R2 = 0,72, PMYD88 L265P mutations in PBMCs of IgM MGUS and WM patients, which may especially utilized for monitoring minimal residual tumor burden after treatment.

Impact of negative‐pressure wound therapy on bacterial behaviour and bioburden in a contaminated full‐thickness wound

Abstract

The use of negative‐pressure wound therapy (NPWT) has displayed significant clinical benefits in the healing of infected wounds. However, the effects of NPWT on bacterial colonisation and infection of traumatic wounds has been controversial. The aim of this study is to evaluate the impact of NPWT treatment in rabbits with a contaminated full‐thickness wound on bacterial behaviour, including colony morphology, spatial distribution, fissional proliferation, and bacterial bioburden. Full‐thickness wounds were created on the back of rabbits, and were inoculated with bioluminescent Staphylococcus aureus. The wounds were treated with sterile gauze dressings and NPWT with continuous negative pressure (−125 mm Hg). Wound samples were harvested on days 0 (6 hours after bacterial inoculation), 2, 4, 6, and 8 at the centre of wound beds before irrigation. Scanning electron microscopy and transmission electron microscopy (TEM) analyses were performed to determine the characteristic bacteriology. Laser scanning confocal microscopy was performed to obtain bioluminescent images, which were used to observe spatial distribution of the GFP‐labelled S. aureus within the tissue and quantify the bacterial bioburden. NPWT resulted in sparse amounts of scattered bacteria on the wound surface or as sparsely spaced single colonies within the tissue. Wound bioburden on day 8 in the NPWT and gauze groups was 34.6 ± 5.5% and 141.9 ± 15.4% of the baseline values (N = 6), respectively (P < .0001). TEM showed a lack of S. aureus active fission within NPWT‐treated tissue. NPWT can impact S. aureus colony morphology and spatial distribution both on the surface and within wound tissue, and reduce S. aureus as early as 48 hours after therapy initiation. Additionally, NPWT inhibits bacterial fissional proliferation in microcolonies.

A comprehensive validation of very early rule-out strategies for non-ST-segment elevation myocardial infarction in emergency departments: protocol for a multicentre prospective cohort study

Por: Tada · M. · Azuma · H. · Yamada · N. · Kano · K.-i. · Nagai · H. · Maeda · S. · Ishida · H. · Aoyama · T. · Okada · R. · Kawano · T. · Kobuchi · T. · Uzui · H. · Matano · H. · Iwasaki · H. · Maeno · K. · Shimada · Y. · Yoshida · H. · Ando · M. · Murakami · Y. · Iwakami · N. · Kishimoto · S. · Iw
Introduction

Recent advances in troponin sensitivity enabled early and accurate judgement of ruling-out myocardial infarction, especially non-ST elevation myocardial infarction (NSTEMI) in emergency departments (EDs) with development of various prediction-rules and high-sensitive-troponin-based strategies (hs-troponin). Reliance on clinical impression, however, is still common, and it remains unknown which of these strategies is superior. Therefore, our objective in this prospective cohort study is to comprehensively validate the diagnostic accuracy of clinical impression-based strategies, prediction-rules and hs-troponin-based strategies for ruling-out NSTEMIs.

Methods and analysis

In total, 1500 consecutive adult patients with symptoms suggestive of acute coronary syndrome will be prospectively recruited from five EDs in two tertiary-level, two secondary-level community hospitals and one university hospital in Japan. The study has begun in July 2018, and recruitment period will be about 1 year. A board-certified emergency physician will complete standardised case report forms, and independently perform a clinical impression-based risk estimation of NSTEMI. Index strategies to be compared will include the clinical impression-based strategy; prediction rules and hs-troponin-based strategies for the following types of troponin (Roche Elecsys hs-troponin T; Abbott ARCHITECT hs-troponin I; Siemens ADVIA Centaur hs-troponin I; Siemens ADVIA Centaur sensitive-troponin I). The reference standard will be the composite of type 1 MI and cardiac death within 30 days after admission to the ED. Outcome measures will be negative predictive value, sensitivity and effectiveness, defined as the proportion of patients categorised as low risk for NSTEMI. We will also evaluate inter-rater reliability of the clinical impression-based risk estimation.

Ethics and dissemination

The study is approved by the Ethics Committees of the Kyoto University Graduate School and Faculty of Medicine and of the five hospitals where we will recruit patients. We will disseminate the study results through conference presentations and peer-reviewed journals.

Patient experience of treatment decision making for wet age-related macular degeneration disease: a qualitative study in China

Por: Bian · W. · Wan · J. · Tan · M. · Wu · X. · Su · J. · Wang · L.
Objectives

This study aimed to investigate the experience of patients with wet age-related macular degeneration (wAMD) in treatment decision-making process.

Design

A descriptive qualitative study was designed by using semistructured interviews, and the data analysis was conducted with the thematic analysis approach.

Participants and setting

A convenient and purposive sample of 21 participants diagnosed with wAMD was recruited from May 2018 to September 2018. The study was conducted in the Eye Clinic of Southwest Hospital of Army Medical University in Chongqing located in the southwest of China.

Results

The mean age of the participants was 64.48 years (ranging 50–81 years), and the duration of the disease ranged from 6 months to 48 months. Four major themes were identified from the original data analysis. These themes included facing the darkness (choosing from light and darkness and living in pain), constraints on decision making (doctor-oriented decision making, inadequacy of options and time), weighing alternatives (family influence, financial burden and maintaining social function) and decision-making support (professional decision-making assistance and peer support).

Conclusion

This is a qualitative study attempting to explore the patient experience of treatment decision making for wAMD disease in China. Previous literature has focused on treatment effect and symptoms, rather than the individual experience and the wide contexts from a sociocultural perspective. Further studies, such as cross-sectional studies, can be used to describe the status and determine the influencing factors of decision0making process, so as to develop an impact factor model of decision making and to formulate an intervention for patients with wAMD.

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.

Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness

Por: Tandogdu · Z. · Lewis · R. · Duncan · A. · Penegar · S. · McDonald · A. · Vale · L. · Shen · J. · Kelly · J. D. · Pickard · R. · N Dow · J. · Ramsay · C. · Mostafid · H. · Mariappan · P. · Nabi · G. · Creswell · J. · Lazarowicz · H. · McGrath · J. · Taylor · E. · Clark · E. · Maclennan · G.
Introduction

Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.

Methods and analysis

PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients’ lifetime.

Ethics and dissemination

Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.

Trial registration number

ISRCTN84013636.

Pruritus in patients with chronic leg ulcers: A frequent and often neglected problem

Abstract

There is a paucity of studies regarding pruritus in patients with chronic leg ulcers. Data were collected using newly developed questionnaires for patients and physicians to evaluate pruritus in individuals with chronic leg ulcers. The results show that a total of 50 patients with chronic leg ulcers were included in this prospective study. Frequent pruritus was observed in 32.0% of the participants, while 36.0% reported occasional pruritus. The average pruritus intensity was 3.5 points (0‐10 numeric rating scale [NRS]) and was found to increase with age. Patients experiencing pruritus achieved a higher Wound‐quality of life (QoL) score (32.1) as that of patients without pruritus (25.8). Additional dermatological findings around the wounds included xerosis (26.0%), eczema (4.0%), and excoriations (2.0%). Pruritus was reported by all subjects with eczema and 84.6% of those with xerosis. The pruritus lasted significantly longer in women (average 98.4 months) vs men (average 37.5 months). Interestingly, men reported more intense pruritus than women (4.4 vs 2.8). Females reported more frequent use of skin care products than males. In conclusion, the current data show that two‐thirds of patients with chronic leg ulcers suffer from moderate intense pruritus. Therefore, pruritus is a frequent and often neglected problem that should be regularly evaluated in all patients with chronic leg ulcers and considered in future therapy concepts.

A Romanian experience of syphilis in pregnancy and childbirth

Syphilis is a sexually transmitted disease that, left untreated, leads to systemic complications. It has chronic development and multiple clinical manifestations, mimicking many dermatological conditions (Oswal and Lyons, 2008; Manolescu et al., 2017). Syphilis is caused by Treponema pallidum, which only affects humans and some primates and is usually transmitted through sexual contact (Oswal and Lyons, 2008; Manolescu et al., 2017). Other possible transmission routes are by blood or from mother to fetus during pregnancy (Oswal and Lyons, 2008).

Relationship between gay app use and HIV testing among men who have sex with men in Shenzhen, China: a serial cross-sectional study

Por: Wei · L. · Chen · L. · Zhang · H. · Yang · Z. · Liu · S. · Tan · W. · Xie · W. · Liu · L. · Zhao · J. · Cheng · J.
Objectives

To investigate the relationship between gay app use and HIV testing among men who have sex with men (MSM).

Design

Serial cross-sectional study.

Setting

A newly well-developed city in China.

Participants

4935 MSM were recruited through offline sampling methods from 2015 to 2017.

Primary and secondary outcomes

The primary outcome is the difference in HIV testing between app and non-app users.

Results

2872 (58.2%) and 2159 (43.7%) participated MSM had been tested for HIV within lifetime and the past year, respectively. Compared with non-app-using MSM, app-using MSM had a significantly higher prevalence of HIV testing within lifetime (adjusted OR (AOR): 1.48, 95% CI 1.27 to 1.72) and the past year (AOR: 1.36, 95% CI 1.18 to 1.57). App-using MSM were more likely to take an HIV test at the Centers for Disease Control and Prevention (AOR: 1.48, 95% CI 1.24 to 1.76) and community-based organisations (AOR: 1.71, 95% CI 1.44 to 2.03), but less often at gay venues (AOR: 0.49, 95% CI 0.37 to 0.63). Meanwhile, app-using MSM were more likely to take self-testing (AOR: 1.61, 95% CI 1.21 to 2.14). Predictors of HIV testing in the past year were: having an education level of college or higher (AOR: 1.29, 95% CI 1.01 to 1.65), being self-identified as a homosexual (AOR: 1.23, 95% CI 1.02 to 1.46), being recruited through clinic-based sampling (AOR: 1.30, 95% CI 1.06 to 1.60), using gay app (AOR: 1.49, 95% CI 1.21 to 1.83), engaging in group sex (AOR: 1.64, 95% CI 1.23 to 2.19), having received HIV-related service (AOR: 5.49, 95% CI 4.57 to 6.60), having a high level of HIV-related knowledge (AOR: 1.33, 95% CI 1.10 to 1.61) and high-risk perception (AOR: 2.95, 95% CI 1.40 to 6.23).

Conclusions

Gay app use was significantly associated with increased HIV testing among MSM hard to reach by traditional outreach. Therefore, it is imperative to expand HIV testing among non-app-using MSM. Continued efforts, innovative strategies and increased resource are highly needed to realise the first ‘90’ target.

The utility of Ki-67 as a prognostic biomarker in pulmonary neuroendocrine tumours: protocol for a systematic review and meta-analysis

Por: Naheed · S. · Holden · C. · Tanno · L. · Jaynes · E. · Cave · J. · Ottensmeier · C. H. · Pelosi · G.
Introduction

The omission of the immunohistochemical proliferation marker Ki-67 labelling index (henceforth, simply Ki-67) from the 2015 WHO classification system of pulmonary neuroendocrine tumours (Lung-NETs) as a prognostic and grading criterion remains controversial. This systematic review along with meta-analysis will be conducted to assess the prognostic/grading utility of Ki-67 in Lung-NETs.

Methods

This systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A systematic search of MEDLINE Ovid, Embase, Scopus and the Cochrane Library will be performed from the inception of each database to 28 February 2019 for studies investigating any role of Ki-67 in Lung-NETs. Only full papers published in English detailing survival outcomes and HRs according to Ki-67 will be included. The primary endpoint will be establishing whether Ki-67 is a reliable marker in determining prognosis and thus assessing grade of Lung-NETs patients.

Ethics and dissemination

Ethical approval will not be required as this is an academic review of published literature. Findings will be disseminated through the preparation of a manuscript for publication in a peer-reviewed journal as well as presentation at national and international conferences.

PROSPERO registration number

CRD42018093389

Choosing Healthy Eating for Infant Health (CHErIsH) study: protocol for a feasibility study

Por: Matvienko-Sikar · K. · Toomey · E. · Queally · M. · Flannery · C. · O Neill · K. · Dinan · T. G. · Doherty · E. · Harrington · J. M. · Hayes · C. · Heary · C. · Hennessy · M. · Kelly · C. · Mc Hugh · S. M. · McSharry · J. · Stanton · C. · Heffernan · T. · Byrne · M. · Kearney · P. M.
Introduction

Childhood obesity is a public health challenge. There is evidence for associations between parents’ feeding behaviours and childhood obesity risk. Primary care provides a unique opportunity for delivery of infant feeding interventions for childhood obesity prevention. Implementation strategies are needed to support infant feeding intervention delivery. The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (HCP)-level implementation strategy to support delivery.

Methods and analysis

This protocol provides a description of a non-randomised feasibility study of an infant feeding intervention and implementation strategy, with an embedded process evaluation and economic evaluation. Intervention participants will be parents of infants aged ≤6 weeks at recruitment, attending a participating HCP in a primary care practice. The intervention will be delivered at the infant’s 2, 4, 6, 12 and 13 month vaccination visits and involves brief verbal infant feeding messages and additional resources, including a leaflet, magnet, infant bib and sign-posting to an information website. The implementation strategy encompasses a local opinion leader, HCP training delivered prior to intervention delivery, electronic delivery prompts and additional resources, including a training manual, poster and support from the research team. An embedded mixed-methods process evaluation will examine the acceptability and feasibility of the intervention, the implementation strategy and study processes including data collection. Qualitative interviews will explore parent and HCP experiences and perspectives of delivery and receipt of the intervention and implementation strategy. Self-report surveys will examine fidelity of delivery and receipt, and acceptability, suitability and comprehensiveness of the intervention, implementation strategy and study processes. Data from electronic delivery prompts will also be collected to examine implementation of the intervention. A cost–outcome description will be conducted to measure costs of the intervention and the implementation strategy.

Ethics and dissemination

This study received approval from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Study findings will be disseminated via peer-reviewed publications and conference presentations.

Factors associated with the occurrence of prehospital medical interventions provided by physicians among non-trauma patients: a single-centre retrospective observational study in Japan

Por: Abe · T. · Iwatani · K. · Aoyama · T. · Ameda · T. · Ochiai · H.
Objectives

Physician-staffed prehospital units are widely used in many countries. The criteria for predicting fatal injury are well recognised for trauma victims, but there are no criteria for predicting critical condition for non-trauma patients. This study aimed to identify the factors associated with non-trauma cases receiving prehospital interventions by physicians.

Design

Retrospective observational study.

Setting

Physician-staffed prehospital unit (car) at a single-base hospital in a suburban city in Japan.

Participants

Participants were 1058 non-trauma patients who received prehospital medical examinations from April 2014 to December 2017.

Outcome measures

The outcome was the occurrence of physician-only interventions (POIs) exceeding paramedics’ competencies. Univariate analysis and multiple logistic regression analysis were performed. Patient’s age and gender, presumed disease category, type of location of the emergency, time of alarm, activation time, activator’s occupation, time to arrival, transportation time and the destination facility were included as covariates.

Results

POIs were provided to 380 (36%) patients. Patient’s age, presumed disease category, type of location of the emergency, activator’s occupation, time to arrival, transportation time and the destination facility were identified as potential independent factors. Multiple logistic regression analysis found that patient’s age, presumed disease category, type of location of the emergency, transportation time and destination facility were the significant independent factors. Transportation times of more than 15 min (adjusted ORs (AORs)=4.17, 95% CI 2.59 to 6.72, p

Conclusions

This study identified the factors associated with non-trauma cases receiving prehospital POIs. Patient’s age, presumed disease category, type of location of the emergency and transportation time are independent factors associated with requiring POIs.

Long-term psychological recovery process and its associated factors among survivors of the Great Hanshin-Awaji Earthquake in Japan: a qualitative study

Por: Tanaka · E. · Tennichi · H. · Kameoka · S. · Kato · H.
Objectives

The 1995 Great Hanshin-Awaji Earthquake had an enormous negative impact on survivors’ health. Many survivors experienced psychological distress and their long-term psychological recovery process remains unclear. Our objective was thus to explore this long-term psychological recovery process.

Design

Qualitative study.

Setting

From January to December 2015, face-to-face interviews were conducted in Kobe, Japan.

Participants

20 affected survivors (55% female; ages ranged from 7 to 60 at the time of the disaster)—10 volunteer storytellers, six first responders (firefighters/public health nurses) and four post-traumatic stress disorder patients.

Outcome measures

We asked participants about their experiences and psychological distress relating to the earthquake and what facilitated or hindered their psychological recovery. We analysed interview data using constructivist grounded theory.

Results

Participants experienced diverse emotional reactions immediately after the disaster and often hyperfocused on what they should do now. This hyperfocused state led to both mental and physical health problems several months after the disaster. Months, and sometimes years, after the disaster, guilt and earthquake narratives (ie, expressing thoughts and feelings about the earthquake) played key roles in survivors’ psychological recovery: guilt suppressed their earthquake narrative; conversely, the narrative alleviated feelings of distress about the earthquake. In time, participants reconsidered their earthquake experiences both alone and through social interaction. This alleviated their emotional reactions; however, participants still experienced attenuated emotional reactions, and some hid their feelings of distress even 20 years postdisaster. Interpersonal relationships modified this psychological process both positively and negatively.

Conclusions

Future psychosocial support plans for disaster survivors may need to (1) include both mental and physical care in the transition from the acute phase to the recovery phase; (2) facilitate supportive interpersonal relationships for survivors during the mid-term recovery phase and (3) provide long-term psychological support to the most traumatised survivors, even if they appear to be functioning normally.

TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol

Por: Martin · J. · Keall · P. · Siva · S. · Greer · P. · Christie · D. · Moore · K. · Dowling · J. · Pryor · D. · Chong · P. · McLeod · N. · Raman · A. · Lynam · J. · Smart · J. · Oldmeadow · C. · Tang · C. I. · Murphy · D. G. · Millar · J. · Tai · K. H. · Holloway · L. · Reeves · P. · Hayden · A.
Introduction

Stereotactic body radiotherapy (SBRT) is a non-invasive alternative to surgery for the treatment of non-metastatic prostate cancer (PC). The objectives of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation (NINJA) clinical trial are to compare two emerging SBRT regimens for efficacy with technical substudies focussing on MRI only planning and the use of knowledge-based planning (KBP) to assess radiotherapy plan quality.

Methods and analysis

Eligible patients must have biopsy-proven unfavourable intermediate or favourable high-risk PC, have an Eastern Collaborative Oncology Group (ECOG) performance status 0-1 and provide written informed consent. All patients will receive 6 months in total of androgen deprivation therapy. Patients will be randomised to one of two SBRT regimens. The first will be 40 Gy in five fractions given on alternating days (SBRT monotherapy). The second will be 20 Gy in two fractions given 1 week apart followed 2 weeks later by 36 Gy in 12 fractions given five times per week (virtual high-dose rate boost (HDRB)). The primary efficacy outcome will be biochemical clinical control at 5 years. Secondary endpoints for the initial portion of NINJA look at the transition of centres towards MRI only planning and the impact of KBP on real-time (RT) plan assessment. The first 150 men will demonstrate accrual feasibility as well as addressing the KBP and MRI planning aims, prior to proceeding with total accrual to 472 patients as a phase III randomised controlled trial.

Ethics and dissemination

NINJA is a multicentre cooperative clinical trial comparing two SBRT regimens for men with PC. It builds on promising results from several single-armed studies, and explores radiation dose escalation in the Virtual HDRB arm. The initial component includes novel technical elements, and will form an important platform set for a definitive phase III study.

Trial registration number

ANZCTN 12615000223538.

Prevalence and factors associated with suicide among medical professionals in low/middle-income countries: a systematic review protocol

Por: Rukundo · G. Z. · Byakwaga · H. · Kinengyere · A. · Bapolisi · A. M. · Betancourt · M. · Akena · D.
Introduction

A number of studies in low/middle-income countries (LMICs) have reported varying prevalence of suicide among medical professionals with low rates. This may be because of the methods used in suicide assessment and the stigma associated with it. For this study, the prevalence of suicidal ideation, attempt and completed suicide, as well as the factors associated with suicidality and methods used during suicidal acts, will be documented.

Methods and analysis

Studies published in peer-reviewed journals in which the prevalence and factors associated with suicidal ideation, attempt and completion among medical professionals in LMICs will be included. The Cochrane Library (CENTRAL), PsychINFO, PubMed and Embase will be systematically searched. We will search for all the papers available in the databases up to March 31 2019. Methodological quality of the articles will be assessed using the quality in prognostic studies tool. The risk of bias of the articles will be assessed using Cochrane risk of bias assessment tool for non-randomised studies. In the event of no statistical heterogeneity, a meta-analysis of the findings will be conducted.

Ethics and dissemination

Ethical permission will not be required since this work does not involve the use of participant data that can be used to identify individuals. Findings from this study will be available for clinicians and other medical professionals, scientists and policy makers. On request, a data set of the study can be provided.

Trial registration number

CRD42018095990.

Real-time navigation during hepatectomy using fusion indocyanine green-fluorescence imaging: protocol for a prospective cohort study

Por: Gon · H. · Komatsu · S. · Murakami · S. · Kido · M. · Tanaka · M. · Kuramitsu · K. · Tsugawa · D. · Awazu · M. · Toyama · H. · Fukumoto · T.
Introduction

In-vivo fluorescence imaging techniques using indocyanine green (ICG) to identify liver tumours and hepatic segment boundaries have been recently developed. The purpose of this study is to evaluate the efficacy of fusion ICG-fluorescence imaging for navigation during hepatectomy.

Methods and analysis

This will be an exploratory single-arm clinical trial; patients with liver tumours will undergo hepatectomy using the ICG-fluorescence imaging system. In total, 110 patients with liver tumours scheduled for elective hepatectomy will be included in this study. Preoperatively, ICG will be intravenously injected at a dose of 0.5 mg/kg body weight within 2 days. To detect liver tumours intraoperatively, the hepatic surface will be initially observed using the ICG-fluorescence imaging system. After identifying and clamping the portal pedicle corresponding to the hepatic segments, including the liver tumours to be resected, additional ICG will be injected intravenously at a dose of 0.5 mg/kg body weight to identify the boundaries of the hepatic segments. The primary outcome measure will be the success or failure of the ICG-fluorescence imaging system in identifying hepatic segments. The secondary outcomes will be the success or failure in identifying liver tumours, liver function indicators, operative time, blood loss, rate of postoperative complications and recurrence-free survival. The findings obtained through this study are expected to help to establish the utility of ICG-fluorescence imaging systems, and therefore contribute to prognostic outcome improvements in patients undergoing hepatectomy for various causes.

Ethics and dissemination

The protocol has been approved by the Kobe University Clinical Research Ethical Committee. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number

UMIN000031054 and jRCT1051180070

Risk factors for contrast-induced acute kidney injury (CI-AKI): protocol for systematic review and meta-analysis

Por: Liu · Y. · Liang · X. · Xin · S. · Liu · J. · Sun · G. · Chen · S. · Cen · X. · Dai · X. · He · Y. · Song · F. · Liang · Y. · Hu · Y. · Zhou · Y. · Chen · Z. · Tan · N. · Chen · J.
Introduction

Identifying the patients who are at risk for contrast-induced acute kidney injury (CI-AKI), which is defined as an increase in serum creatinine after exposure to contrast media, is a critical step in targeted prevention strategies. The absolute and relative importance of individual risk factors have not been systematically evaluated, let alone the new, controversial and modifiable risk factors of CI-AKI.

Methods and analysis

On 1 July 2019, a search was performed on MEDLINE, Embase and the Cochrane Database of Systematic Reviews. We will perform a systematic review and meta-analysis to assess the important risk factors for developing CI-AKI, including those new, modifiable factors, which are considered controversial. The secondary endpoint will be all-cause mortality. Two authors will then independently screen studies that meet the criteria for inclusion, consulting with a third author to resolve any dispute. The quality of the included studies will be assessed according to the Newcastle-Ottawa scale.

Ethics and dissemination

Ethics approval in this systematic review and meta-analysis protocol is not needed. We will disseminate the findings of this systematic review and meta-analysis via publications in peer-reviewed journals.

PROSPERO registration number

CRD42019121534

Does closed incision negative wound pressure therapy in non‐traumatic major lower‐extremity amputations improve survival rates?

Abstract

Closed incision negative pressure wound therapy (CINPWT) has been shown to be clinically effective compared with the traditional gauze dressing, reducing surgical site infections and wound complications. We evaluated the effect of CINPWT compared with gauze dressing on the need for revision surgery and survival after non‐traumatic major lower amputation. We included 309 patients undergoing 403 major lower amputations in a retrospective study from January 1, 2010 to November 23, 2017. A total of 139 patients received CINPWT, and 170 patients received stump bandage. There was no statistically significant difference between the two groups regarding the need for revision surgery (P = .45). Fourteen stump bandage patients and 15 CINPWT patients died in hospital (P = .57). One year after amputation, 55 CINPWT patients and 66 stump bandage patients had died (P = .82). Survival probabilities adjusted for age and gender 2 years after amputation were .52 (.43‐.61) and .49 (.42‐.58), respectively, and 3 years after amputation were .36 (.25‐.50) and .39 (.32‐.47), respectively. We also found no significant difference in the need for revision surgery in survival probabilities up till 3 years after amputation between patients treated with CINPWT and patients treated with gauze bandage postoperatively.

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