bluuebunny/crossref_metadata_2025 huggingface dataset:
Virulence factors of medically important fungi
Authors: Hogan L H , Klein B S , Levitz S M
Published: October 2018

Human fungal pathogens have become an increasingly important medical problem with the explosion in the number of immunocompromised patients as a result of cancer, steroid therapy, chemotherapy, and AIDS. Additionally, the globalization of travel and expansion of humankind into previously undisturbed habitats have led to the reemergence of old fungi and new exposure to previously undescribed fungi. Until recently, relatively little was known about virulence factors for the medically important fungi. With the advent of molecular genetics, rapid progress has now been made in understanding the basis of pathogenicity for organisms such as Aspergillus species and Cryptococcus neoformans. The twin technologies of genetic transformation and "knockout" deletion construction allowed for genetic tests of virulence factors in these organisms. Such knowledge will prove invaluable for the rational design of antifungal therapies. Putative virulence factors and attributes are reviewed for Aspergillus species, C. neoformans, the dimorphic fungal pathogens, and others, with a focus upon a molecular genetic approach. Candida species are excluded from coverage, having been the subject of numerous recent reviews. This growing body of knowledge about fungal pathogens and their virulence factors will significantly aid efforts to treat the serious diseases they cause.
Pneumocystis carinii: what is it, exactly?
Authors: Stringer J R
Published: October 2018

The identity of Pneumocystis carinii has been uncertain for many years. Until recently, it was widely regarded to be a protozoan because it does not grow in culture and is not susceptible to antifungal drugs. Although these and a number of other phenotypic characteristics of P. carinii differ from those of typical fungi, analysis of DNA sequences has shown that P. carinii is a member of the fungal lineage of eukaryotes. However, a close phylogenetic relative of P. carinii has not yet been found. Analysis of gene sequences has also revealed that P. carinii is not a single entity but that the genus Pneumocystis contains a complex group of organisms. P. carinii organisms from one host species do not grow when introduced into another host species, and P. carinii isolates from different host species are more genetically divergent from one another than might be expected for members of the same species. Genetic variation of a lesser degree also occurs among P. carinii organisms from the same host species, suggesting that it may be possible to identify strains and to conduct transmission and epidemiological studies. Results of early studies exploiting genetic variation among P. carinii isolates from patients have suggested that recurrent P. carinii pneumonia may not always be caused by reactivation of latent organisms, as is commonly believed. However, other features of P. carinii suggest that this microbe has established a long-term relationship with its host. A striking new development in this regard is the discovery of a genetic system that is designed to allow variation in the structure of a major antigen on the surface of P. carinii.
The Evolution of Genotyping Strategies To Detect, Analyze, and Control Transmission of Tuberculosis
Authors: García De Viedma Darío , Pérez-Lago Laura
Published: October 2018

The introduction of genotypic tools to analyze
Mycobacterium tuberculosis
isolates has transformed our knowledge of the transmission dynamics of this pathogen. We discuss the development of the laboratory methods that have been applied in recent years to study the epidemiology of
M. tuberculosis
. This review integrates two approaches: on the one hand, it considers how genotyping techniques have evolved over the years; and on the other, it looks at how the way we think these techniques should be applied has changed. We begin by examining the application of fingerprinting tools to suspected outbreaks only, before moving on to universal genotyping schemes, and finally we describe the latest real-time strategies used in molecular epidemiology. We also analyze refined approaches to obtaining epidemiological data from patients and to increasing the discriminatory power of genotyping by techniques based on genomic characterization. Finally, we review the development of integrative solutions to reconcile the speed of PCR-based methods with the high discriminatory power of whole-genome sequencing in easily implemented formats adapted to low-resource settings. Our analysis of future considerations highlights the need to bring together the three key elements of high-quality surveillance of transmission in tuberculosis, namely, speed, precision, and ease of implementation.
Newborn self-inflating manual resuscitators: precision robotic testing of safety and reliability
Authors: Tracy Mark B , Halliday Robert , Tracy Sally K , Hinder Murray K
Published: October 2018

Aim

A controlled bench test was undertaken to determine the performance variability among a range of neonatal self-inflating bags (SIB) compliant with current International Standards Organisation (ISO).

Introduction

Use of SIB to provide positive pressure ventilation during newborn resuscitation is a common emergency procedure. The United Nations programmes advocate increasing availability of SIB in low-income and middle-income nations and recommend devices compliant with ISO. No systematic study has evaluated variance in different models of neonatal SIB.

Methods

20 models of SIB were incrementally compressed by an automated robotic device simulating the geometry and force of a human hand across a range of precise distances in a newborn lung model. Significance was calculated using analysis of variance repeated measures to determine the relationship between distance of SIB compression and delivered ventilation. A pass/fail was derived from a composite score comprising: minimum tidal volume; coefficient of variation (across all compression distances); peak pressures generated and functional compression distance.

Results

Ten out of the 20 models of SIB failed our testing methodology. Two models could not provide safe minimum tidal volumes (2.5–5 mL); six models exceeded safety inflation pressure limit >45 cm H2O, representing 6% of their inflations; five models had excessive coefficient of variation (>30% averaged across compression distances) and three models did not deliver inflation volumes >2.5 mL until approximately 50% of maximum bag compression distance was reached. The study also found significant intrabatch variability and forward leakage.

Conclusion

Compliance of SIBs with ISO standards may not guarantee acceptable or safe performance to resuscitate newborn infants.
Synthetic biodegradable alternatives to the use of the amniotic membrane for corneal regeneration: assessment of local and systemic toxicity in rabbits
Authors: Ramachandran Charanya , Sangwan Virender S , Ortega Ilida , Bhatnagar Upendra , Mulla Sadik Mohmad Abdulhamid , McKean Rob , MacNeil Sheila
Published: October 2018

Aim

The aim of this study was to assess the local and systemic response to poly-lactic co-glycolic acid (PLGA) 50:50 membranes, developed as synthetic biodegradable alternatives to the use of human donor amniotic membrane in the treatment of limbal stem cell deficiency.

Methods

PLGA membranes of 2  cm diameter and 50  µm thickness were placed on one eye of rabbits and secured in place using fibrin glue and a bandage contact lens, suturing the eye close with a single stitch. Control animals were treated identically, with the absence of the membranes. Plain and microfabricated electrospun membranes (containing micropockets which roughly emulate the native limbal niche) were examined over 29 days. All animals were subjected to a detailed gross and histopathological observation as well as a detailed examination of the eye.

Results

Application of the membranes both with and without microfabricated pockets did not adversely affect animal welfare. There was complete degradation of the membranes by day 29. The membranes did not induce any significant local or systemic toxicity. Conjunctival congestion and corneal vascularisation were noted in a few control and PLGA-treated animals. Intraocular pressure was normal and the retinal status was unaltered. The ocular surface was clear and intact in all animals by the end of 29  days.

Conclusion

Membranes of 50:50 PLGA can be safely applied to rabbit corneas without inducing any local or systemic toxicity and these break down completely within 29 days.
Arrabidaea chicafor oral mucositis in patients with head and neck cancer: a protocol of a randomised clinical trial
Authors: Queiroz Núbia de Cassia Almeida , Jorge Michelle Pedroza , Sousa Ilza Maria de Oliveira , Lima Carmen Silvia Passos , Matias Maria Christina de Miranda , Dal Rio Ana Cristina , Pereira Eduardo Baldon , Galassi Victória Hahn Kakas , de Carvalho João Ernesto , Galvao Tais Freire , Foglio Mary Ann
Published: October 2018

Introduction

Oral mucositis is an iatrogenic condition of erythematous inflammatory changes which tends to occur on buccal and labial surfaces, the ventral surface of the tongue, the floor of the mouth and the soft palate of patients receiving chemotherapy. This protocol of ongoing randomised parallel group clinical trial aims to access the therapeutic effect of an herbal gel containing 2.5%Arrabidaea chicaVerlot standardised extract on oral mucositis in patients with head and neck cancer compared with low-level laser therapy.

Methods and analysis

Patients with head and neck cancer held at Clinics Hospital of University of Campinas, Sao Paulo, who develop early signs/symptoms of oral mucositis are eligible. Baseline characteristics of participants include oral mucositis grade and quality of life assessments. Enrolment started in November 2017 with allocation of patients to one of the study groups by means of randomisation. Patients will be treated either withArrabidaea chicaor laser until wound healing. Monitoring includes daily assessment of mucositis grade and diameter measurement by photographs and millimetre periodontal probe. Treatments will be concluded once mucositis is healed. A blinded assessor will evaluate mucositis cure after referred by the study team. At this point, the gel tube will be weighed to indirectly assess patient’s compliance. At close-out, data will be analysed by a blinded researcher following the procedures described in the statistical analyses.

Ethics and dissemination

This clinical trial was approved by the ethics committee of research in humans at the Faculty of Medical Sciences of University of Campinas (report no. 1,613,563/2016). Results from this trial will be communicated in peer-reviewed publications and scientific presentations.

Trial registration number

RBR-5×4397.
Engineering standards for trauma and orthopaedic implants worldwide: a systematic review protocol
Authors: Henshaw Frederick , Karasouli Eleni , King Richard , Rahman Usama , Langton David , Madete June , Otsyeno Fred , Mutiso Vincent , Atinga John , Underwood Martin , Williams Mark , Metcalfe Andrew
Published: October 2018

Introduction

Despite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies all produce engineering standards; therefore, the comparison of surgical implants across different manufacturers and jurisdictions is difficult. In this review, we will systematically collate and compare engineering standards for trauma and orthopaedic implants around the world. This will help inform patient, hospital and surgeon choice and provide an evidence base for future research in this area.

Methods and analysis

This protocol is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will conduct a systematic review of trauma and orthopaedic engineering standards from four main sources of information as identified in our preliminary scoping searches: governments, industry, independent regulatory bodies and engineering and medical publications. Any current standard relevant to trauma and orthopaedic implants will be included. We will use a predefined search strategy and follow the recommendations of the Cochrane handbook where applicable. We will undertake a narrative synthesis with qualitative evaluation of homogeneity between engineering standards.

Ethics and dissemination

No ethics approval is required as no primary data are being collected. The results will be made available by peer-reviewed publication and reported according to PRISMA-P guidelines.
Models of suicide in elderly: a protocol for a systematic review
Authors: Rostami Mohammad , Younesi Seyyed Jalal , Mohammadi Shahboulaghi Farahnaz , Malakouti Seyed Kazem , Foroughan Mahshid
Published: October 2018

Introduction

The rates of suicide in the elderly population are generally higher than other age groups. Models of suicide that explain the phenomenon of suicide in later life may have research, clinical and educational implications for the field of ageing. The primary purpose of this systematic review is to identify and review existing models of suicide that have a particular focus on the elderly.

Methods and analysis

The authors intend reviewing the findings of observational studies including cohort studies, cross-sectional studies, case–control studies, and qualitative studies such as grounded theory designs which are published in Google Scholar, Scopus, PsycINFO, PubMed, Web of Science, Cochrane Database of Systematic Reviews and research-related journals. Models of suicide which specifically describe, explain and predict late life suicides will be included. Therapeutic, interventional and rehabilitation models, as well as models related to assisted suicide, will be excluded. The EndNote software will be employed for data management. Two independent reviewers will extract data. Methodological quality and the risk of bias of quantitative studies will be assessed using the Newcastle-Ottawa Scale and the Newcastle-Ottawa Scale adapted for cross-sectional studies, while that of qualitative studies will be assessed using the Critical Appraisal Skills Programme and the evaluative criteria of credibility, transferability, dependability and confirmability. The final report will present a range of models of suicide with a list of different subgroups.

Ethics and publication

There are no predictable ethical issues related to this study. The findings will be published in prestigious journals and presented at international and national conferences.

PROSPERO registration number

CRD42017070982.
Regional differences in endoscopic sinus surgery in Finland: a nationwide register-based study
Authors: Toppila-Salmi Sanna , Rihkanen Heikki , Arffman Martti , Manderbacka Kristiina , Keskimaki Ilmo , Hytönen Maija L
Published: October 2018

Objectives

Endoscopic sinus surgery (ESS) is a common operation typically performed due to chronic rhinosinusitis (CRS). There are limited data on the nationwide ESS rate and factors contributing to its regional variation. The aim was to evaluate factors causing variation of ESS rate.

Design

Cross-sectional nationwide observational study.

Setting

A ll patients undergoing ESS in Finland 2013–2015.

Population

Nationwide Finnish population aged 15 years or over.

Main outcome measures

ESS rate per 1000 inhabitants between 2013 and 2015 in all 21 hospital districts and independent factors for multilevel model analyses.

Methods

We used the Finnish register data of all patients with CRS who underwent ESS in 2013–2015. Patients aged under 15 years and those with ESS due to neoplasia were excluded. The age and gender standardised ESS rates were calculated, and multilevel Poisson regression models were used to evaluate variation in ESS in the 21 hospital districts. The likelihood ratio test was applied to assess the statistical significance of random components in the models.

Results

The nationwide annual rate of ESS is 0.71 per 1000 people in Finland. Hospital district rates varied from 0.25/1000 (95% CI 0.18 to 0.32) to 1.15/1000 (95% CI 1.09 1.21). Compared with males, females undergo ESS significantly more frequently (57% of the procedures), more often due to CRS without nasal polyps, and at a younger age (mean age 44.2 and 46.2 years, correspondingly). Multilevel analyses showed that lower age (between 24 years and 45 years) and availability/ease of medical services were independently associated with higher ESS rates.

Conclusions

This study confirms marked regional variation in the ESS rate in Finland, explained only in part by patients’ age and differing availability of medical services. To analyse ESS across different CRS phenotypes or to compare quality registers on ESS properly, more research on regional variation is needed.
Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol
Authors: Williamson Esther , Ward Lesley , Vadher Karan , Dutton Susan J , Parker Ben , Petrou Stavros , Hutchinson Charles E , Gagen Richard , Arden Nigel K , Barker Karen , Boniface Graham , Bruce Julie , Collins Gary , Fairbank Jeremy , Fitch Judith , French David P , Garrett Angela , Gandhi Varsha , Griffiths Frances , Hansen Zara , Mallen Christian , Morris Alana , Lamb Sarah E
Published: October 2018

Introduction

Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention.

Methods and analysis

This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study.

Ethics and dissemination

Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website.

Trial registration number

ISRCTN12698674; Pre-results.
Readmission and mortality in patients treated by interprofessional student teams at a training ward compared with patients receiving usual care: a retrospective cohort study
Authors: Hallin Karin , Gordon Max , Sköldenberg Olof , Henriksson Peter , Kiessling Anna
Published: October 2018

Objective

This study aimed to compare the rate of patient readmissions and mortality between care provided at an orthopaedic interprofessional training ward (IPTW) and usual care.

Design

Retrospective cohort study.

Setting

Orthopaedic wards at a level II trauma centre at a Swedish university teaching hospital between 2006 and 2011.

Participants

Two cohorts were identified: (1) a control cohort that had not received care at the IPTW, and (2) patients who had been treated for at least 1 day at the IPTW.

Main outcome measures

Readmission at 90 days and 1-year mortality.

Results

We included 4652 controls and 1109 in the IPTW group. The mean age was 63 years, and 58% were women. The groups did not differ in any of the outcomes: the readmission rate in the control and IPTW groups was 13.5% and 14.0%, respectively, while mortality was 5.2% and 5.3%, respectively. This lack of difference remained after adjusting for confounders.

Conclusion

Interprofessional undergraduate training in patient-based settings can be performed in a level II trauma hospital with satisfactory patient safety.
Influence of family history on prognosis of spinal pain and the role of leisure time physical activity and body mass index: a prospective study using family-linkage data from the Norwegian HUNT study
Authors: Amorim Anita B , Ferreira Paulo H , Ferreira Manuela L , Lier Ragnhild , Simic Milena , Pappas Evangelos , Zadro Joshua R , Mork Paul Jarle , Nilsen Tom IL
Published: October 2018

Objectives

To investigate the influence of parental chronic spinal pain on prognosis of chronic spinal pain in adult offspring, and whether offspring physical activity level and body mass index (BMI) modified this association.

Design

Prospective cohort study.

Setting

We used family-linked longitudinal data from the Norwegian HUNT study collected in HUNT2 (1995–1997) and HUNT3 (2006–2008).

Participants

A total of 1529 offspring who reported spinal pain in HUNT2 were linked with parental data and followed up in HUNT3.

Outcomes

We estimated relative risk (RR) with 95% CI for recovery from chronic spinal pain, and also from activity limiting spinal pain, in offspring related to chronic spinal pain in parents. We also investigated whether offspring leisure time physical activity and BMI modified these intergenerational associations in spinal pain.

Results

A total of 540 (35%) offspring were defined as recovered after approximately 11 years of follow-up. Offspring with both parents reporting chronic spinal pain were less likely to recover from chronic spinal pain (RR 0.83, 95% CI 0.69 to 0.99) and activity limiting spinal pain (RR 0.71, 95% CI 0.54 to 0.94), compared with offspring of parents without chronic spinal pain. Analyses stratified by BMI and physical activity showed no strong evidence of effect modification on these associations. However, offspring who were overweight/obese and with both parents reporting chronic spinal pain had particularly low probability of recovery from activity limiting spinal pain, compared with those who were normal weight and had parents without chronic spinal pain (RR 0.57, 95% CI 0.39 to 0.84).

Conclusion

Offspring with chronic spinal pain are less likely to recover if they have parents with chronic spinal pain, particularly if offspring are overweight/obese.
Uncovering cynicism in medical training: a qualitative analysis of medical online discussion forums
Authors: Peng Jenny , Clarkin Chantalle , Doja Asif
Published: October 2018

Objective

The development of cynicism in medicine, defined as a decline in empathy and emotional neutralisation during medical training, is a significant concern for medical educators. We sought to use online medical student discussion groups to provide insight into how cynicism in medicine is perceived, the consequences of cynicism on medical trainee development and potential links between the hidden curriculum and cynicism.

Setting

Online analysis of discussion topics in Premed101 (Canadian) and Student Doctor Network (American) forums.

Participants

511 posts from seven discussion topics were analysed using NVivo 11. Participants in the forums included medical students, residents and practising physicians.

Methods

Inductive content analysis was used to develop a data-driven coding scheme that evolved throughout the analysis. Measures were taken to ensure the trustworthiness of findings, including duplicate independent coding of a sub-sample of posts and the maintenance of an audit trail.

Results

Medical students, residents and practising physicians participating in the discussion forums engaged in discourse about cynicism and highlighted themes of the hidden curriculum resulting in cynicism. These included the progression of cynicism over the course of medical training as a coping mechanism; the development of challenging work environments due to factors such as limited support, hierarchical demands and long work hours; and the challenge of initiating change due to the tolerance of unprofessionalism and the highly stressful nature of medicine.

Conclusion

Our unique study of North American medical discussion posts demonstrates that cynicism develops progressively and is compounded by conflicts between the hidden and formal curriculum. Online discussion groups are a novel resource to provide insight into the culture of medical training.
Contextual factors associated with life-space mobility in community-dwelling older adults based on International Classification of Functioning, Disability and Health: protocol for a systematic review
Authors: Britto Heloisa Maria Jácome Sousa , Oliveira Bruna Silva , Gomes Cristiano Santos , Pinto Juliana Martins , Guerra Ricardo Oliveira
Published: October 2018

Introduction

Mobility decline compromises functionality and quality of life in old age. Life-Space Assessment (LSA) evaluates mobility considering interaction between person and environment. The International Classification of Functioning, Disability and Health (ICF) is a reference to identify and categorise the personal and environmental contextual factors associated to the LSA. Our objective is identifying contextual factors that may influence life-space mobility of older community-dwelling adults based on ICF.

Methods and analysis

A systematic review of literature will be performed to identify studies published between 1 January 2001 and 10 May 2017 which investigates life-space mobility among older adults. Keywords will be entered into the electronic databases of MEDLINE (PubMed), EMBASE (OVID), CINHAL (EBSCO), Cochrane Central Register of Controlled Trials Cochrane Central (OVID), PsycINFO (EBSCO) and COCH (OVID). Five investigators will work on search databases and standardised screening of the articles. Mobility predictors will be separated into personal and environmental aspects, according to the ICF model. The results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and then a meta-analysis will be performed, if applicable.

Discussion

Knowledge about life-space mobility in community-dwelling older adults by examining related risk and protective aspects may help practitioners better approach older adults’ mobility and prevent their decline in old age. Furthermore, researchers will have more clues for investigations into factors related to life-space mobility.

Trial registration number

CRD42017064552.
Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia
Authors: Kowark Ana , Adam Christian , Ahrens Jörg , Bajbouj Malek , Bollheimer Cornelius , Borowski Matthias , Dodel Richard , Dolch Michael , Hachenberg Thomas , Henzler Dietrich , Hildebrand Frank , Hilgers Ralf-Dieter , Hoeft Andreas , Isfort Susanne , Kienbaum Peter , Knobe Mathias , Knuefermann Pascal , Kranke Peter , Laufenberg-Feldmann Rita , Nau Carla , Neuman Mark D , Olotu Cynthia , Rex Christopher , Rossaint Rolf , Sanders Robert D , Schmidt Rene , Schneider Frank , Siebert Hartmut , Skorning Max , Spies Claudia , Vicent Oliver , Wappler Frank , Wirtz Dieter Christian , Wittmann Maria , Zacharowski Kai , Zarbock Alexander , Coburn Mark
Published: October 2018

Introduction

Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.

Methods and analysis

The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60.

Ethics and dissemination

iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals.

Trial registration number

DRKS00013644; Pre-results
What is associated with increased side effects and lower perceived efficacy following switching to a generic medicine? A New Zealand cross-sectional patient survey
Authors: MacKrill Kate , Petrie Keith J
Published: October 2018

Objective

Following a switch from either a generic or branded antidepressant (venlafaxine) to a new generic, we investigated the factors associated with a preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic drug.

Design

A cross-sectional survey of patients switched to a new generic.

Setting

Patients accessing venlafaxine information online from the New Zealand government pharmaceuticals funding website.

Participants

310 patients, comprising 205 originally on branded venlafaxine and 105 previously taking a generic version.

Main outcome measures

An online questionnaire assessing demographic factors, perceived sensitivity to medicines, trust in pharmaceutical agencies, sources of switch information, preference for branded medicine, new medicine perceptions, side effects and efficacy ratings.

Results

Preference for branded medicine was significantly stronger in older patients (OR=1.04, 95% CI 1.01 to 1.05), those taking branded venlafaxine (OR=2.02, 95% CI 1.13 to 3.64) and patients with a higher perceived sensitivity to medicine (OR=1.23, 95% CI 1.06 to 1.19). Different factors predicted side effects in those switching from the branded and those switching from the generic venlafaxine. Trust in pharmaceutical agencies and the number of side effects were significant predictors of efficacy ratings of the new generic in both patients switching from a branded and those switching from a generic version of venlafaxine.

Conclusions

In patients switching from a branded medicine and those already taking a generic, different demographic and psychological factors are associated with preference for branded medicine, side effect reporting and perceived efficacy of the new drug. When switching to new generic, there appears to be a close bidirectional relationship between the experience of side effects and perceived drug efficacy. Trust in pharmaceutical agencies impacts directly on perceived efficacy and increasing such trust could reduce the nocebo response following a generic switch.
Evaluating comparative effectiveness of psychosocial interventions for persons receiving opioid agonist therapy for opioid use disorder: protocol for a systematic review
Authors: Rice Danielle B , Hutton Brian , Poulin Patricia , Sproule Beth A , Wolfe Dianna , Moher David , Thavorn Kednapa , Garber Gary , Taha Sheena , Porath Amy , Willows Melanie , Esmaeilisaraji Leila , Yazdi Fatemeh , Shea Beverley , Skidmore Becky , Corace Kimberly
Published: October 2018

Introduction

The opioid crisis has resulted in increasing rates of death caused by problematic opioid use. Current clinical guidelines recommend that individuals with persons with opioid use disorder (OUD) receive pharmacological (eg, opioid agonist therapy) and psychosocial (eg, cognitive behavioural therapy) therapy; however, the best combination of pharmacologic and psychosocial components is not known. Our objective of the planned study is to conduct a comprehensive systematic review to assess the relative benefits of psychosocial interventions as an adjunct to opioid agonist therapy among persons with OUD.

Methods and analysis

A comprehensive search for randomised controlled trials published in English or French will be conducted from database inception to March 2018. The search will be conducted in MEDLINE and translated for Embase, PsycINFO and the Cochrane Central Register of Controlled Trials. Two independent reviewers will screen, extract and assess risk of bias of eligible articles. Primary outcomes of interest will be treatment retention and opioid use (based on urinalysis results). Secondary outcomes will include self-reported opioid use, abstinence from illicit drugs, adherence to psychosocial therapy and opioid agonist therapy, risk for sexually transmitted disease, risk for blood borne pathogens, changes in mental health symptoms (eg, depression), measures of craving and changes in patients’ quality of life and relevant adverse events. If sufficient data and adequate homogeneity exists, network meta-analyses (NMA) will be performed.

Ethics and dissemination

This will be the first systematic review to incorporate NMA to compare psychosocial treatments used as an adjunct to opioid agonist therapy for OUD. Results of this review will inform clinical management of persons with OUD.

Trial registration number

CRD42018090761.
Evaluation of foot health related quality of life in individuals with foot problems by gender: a cross-sectional comparative analysis study
Authors: López-López Daniel , Becerro-de-Bengoa-Vallejo Ricardo , Losa-Iglesias Marta Elena , Palomo-López Patricia , Rodríguez-Sanz David , Brandariz-Pereira Juan Manuel , Calvo-Lobo César
Published: October 2018

Objective

Foot problems (FP) may be considered to be a prevalent conditions in people but there is limited evidence of their effect on the quality of life (QoL) related to foot health in men and women. The aim of this study was to assess the impact of FPs on both overall foot health and QoL, stratified by gender.

Design

A cross sectional study.

Setting

Clinic of Podiatric Medicine and Surgery at University of A Coruña in the city of Ferrol (Spain).

Subjects

The sample consisted of 1647 participants with FP; the total population of the sample had a mean age of 43.24±19.89 years, with mean ages 44.09±21.36 years and 42.94±19.34 years for men and women, respectively.

Methods

Measurement of sociodemographic characteristics include age, sex and body mass index. The Foot Health Status Questionnaire (FHSQ) was used to evaluate the general health and foot health. Differences between groups were evaluated by means of a t-test for independent samples.

Results

Women with FP showed significantly lower scores in the domains of Foot Pain, Foot Function, Footwear, General Foot Health, Physical Activity and Vigour, and there was no difference compared with men in the domains of Overall Health and Social Capacity.

Conclusions

Women with FP present a negative impact on QoL related to foot health as compared with men except in the domains of Overall Health and Social Capacity, which appears to be associated with the presence of foot conditions.
Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial
Authors: Martinez Boris , Webb Meghan Farley , Gonzalez Ana , Douglas Kate , Grazioso Maria del Pilar , Rohloff Peter
Published: October 2018

Objective/background

Guatemala’s indigenous Maya population has one of the highest rates of childhood stunting in the world. The goal of this study was to examine the impact of an intensive, individualised approach to complementary feeding education for caregivers on feeding practices and growth over usual care.

Design

An individually randomised (1:1 allocation ratio), parallel-group superiority trial, with blinding of study staff collecting outcome data.

Setting

Rural Maya communities in Guatemala.

Participants

324 children aged 6–24 months with a height-for-age Z score of less than or equal to −2.5 SD were randomised, 161 to the intervention and 163 to usual care.

Interventions

Community health workers conducted home visits for 6 months, providing usual care or usual care plus individualised caregiver education.

Main outcomes measures

The main outcome was change in length/height-for-age Z score. Secondary outcomes were changes in complementary feeding indicators.

Results

Data were analysed for 296 subjects (intervention 145, usual care 151). There was a non-significant trend to improved growth in the intervention arm (length/height-for-age Z score change difference 0.07(95% CI −0.04 to 0.18)). The intervention led to a 22% improvement in minimum dietary diversity (RR 1.22, 95% CI 1.11 to 1.35) and a 23% improvement in minimal acceptable diet (RR 1.23, 95% CI 1.08 to 1.40) over usual care.

Conclusions

Complementary feeding outcomes improved in the intervention arm, and a non-significant trend towards improved linear growth was observed. Community health workers in a low-resource rural environment can implement individualised caregiver complementary feeding education with significant improvements in child dietary quality over standard approaches.

Clinical trial registration number

NCT02509936.

Stage: Results
Validation of the Primary Care Patient Measure of Safety (PC PMOS) questionnaire
Authors: Giles Sally J , Parveen Sahdia , Hernan Andrea L
Published: October 2018

Background

The Primary Care Patient Measure of Safety (PC PMOS) is designed to capture patient feedback about the contributing factors to patient safety incidents in primary care. It required further reliability and validity testing to produce a robust tool intended to improve safety in practice.

Method

490 adult patients in nine primary care practices in Greater Manchester, UK, completed the PC PMOS. Practice staff (n = 81) completed a survey on patient safety culture to assess convergent validity. Confirmatory factor analysis (CFA) assessed the construct validity and internal reliability of the PC PMOS domains and items. A multivariate analysis of variance was conducted to assess discriminant validity, and Spearman correlation was conducted to establish test–retest reliability.

Results

Initial CFA results showed data did not fit the model well (a chi-square to df ratio (CMIN/DF) = 5.68; goodness-of-fit index (GFI) = 0.61, CFI = 0.57, SRMR = 0.13 and root mean square error of approximation (RMSEA) = 0.10). On the basis of large modification indices (>10), standardised residuals >± 2.58 and assessment of item content; 22 items were removed. This revised nine-factor model (28 items) was found to fit the data satisfactorily (CMIN/DF = 2.51; GFI = 0.87, CFI = 0.91, SRMR = 0.04 and RMSEA = 0.05). New factors demonstrated good internal reliability with average inter-item correlations ranging from 0.20 to 0.70. The PC PMOS demonstrated good discriminant validity between primary care practices (F = 2.64, df = 72, p < 0.001) and showed some association with practice staff safety score (convergent validity) but failed to reach statistical significance (r = −0.64, k = 9, p = 0.06).

Conclusion

This study led to a reliable and valid 28-item PC PMOS. It could enhance or complement current data collection methods used in primary care to identify and prevent error.
What is the real impact of upper limb cast immobilisation on activity-related energy expenditure in children?
Authors: Maggio Albane B R , Martin Xavier Eric , Tabard-Fougère Anne , Delhumeau Cécile , Ceroni Dimitri
Published: October 2018

Background

Upper limb fractures and subsequent cast immobilisation constitute a potential cause of reduction in childhood levels of physical activity (PA), with subsequent decrease of energy consumption. The main objective of this study was thus to quantify the decrease of activity-related energy expenditure (AEE) due to upper limb cast immobilisation .

Methods

We conducted a longitudinal matched case-control study that included 35 children and teenagers with a first episode of upper limb fracture and 35 healthy cases. PA was assessed during cast immobilisation by accelerometer. AEE was the calculated using an equation based on the total counts per day measured by accelerometers.

Results

AEE in children and teenagers with upper limb fractures was estimated to be 7.4 % lower than healthy controls. The mean difference corresponded to 1.35 kcal/kg per mean valid recorded time (750  min), that is, the waking hours. When converted in kcal per mean subjects’ weight, the difference in AEE amounted 63.5 kcal/day, which corresponds approximately to 26  min of walking at a speed of 4  km/hours. In comparison with the mean AEE in healthy controls (18.2 kcal/kg), the noted decrease (1.35 kcal/kg) represents only 7.4 % of AEE.

Conclusion

Reduction of AEE in children and teenagers with upper limb fractures may lead to a slight positive energy balance, as there is usually no compensatory reduction of energy intake. An increase of light PA has to be counselled in this situation or patients should be advised to reduce their energy intake during the immobilisation period.

Level of evidence

Level I: high-quality prospective study (all patients were enrolled at the same point in their disease with ≥80 % follow-up of enrolled patients).
Clinical decision-making at the end of life: a mixed-methods study
Authors: Taylor Paul , Johnson Miriam J , Dowding Dawn Wendy
Published: October 2018

Objectives

To improve the ability of clinical staff to recognise end of life in hospital inpatients dying as a result of cancer and heart failure, and to generate new hypotheses for further research.

Methods

This mixed-methods study used decision theory as a theoretical basis. It involved a parallel databases-convergent design, incorporating findings from previously published research, with equal priority to study groups and synthesis by triangulation. The individual arms were (1) a retrospective cohort study of 102 patients with cancer and 81 patients with heart failure in an acute trust in the North of England, and(2) a semistructured interview study of 19 healthcare professionals caring for the same patient groups.

Results

The synthesis of findings demonstrated areas of agreement, partial agreement, silence and dissonance when comparing the cohort findings with the interview findings. Trajectories of change are identified as associated with poor prognosis in both approaches, but based on different parameters. Management of patients has a significant impact on decision-making. The decision process requires repeated, iterative assessments and may benefit from a multidisciplinary approach. Uncertainty is a defining characteristic of the overall process, and objective parameters only have a limited role in predicting end of life.

Conclusions

The role of uncertainty is important as a trigger for discussions and a defined stage in a patient’s illness journey. This is consistent with current approaches to recognising irreversible deterioration in those with serious illness. This study contributes ongoing evidence that these concepts are vital for decision-making.
The impact of Northern Ireland’s abortion laws on women’s abortion decision-making and experiences
Authors: Aiken Abigail R A , Padron Elisa , Broussard Kathleen , Johnson Dana
Published: October 2018

Background

In Northern Ireland, abortion is illegal except in very limited circumstances to preserve a woman’s life or to prevent permanent or long-term injury to her physical or mental health. Abortions conducted outside the law are a criminal offence punishable by imprisonment. We assessed the impacts of Northern Ireland’s abortion laws on women’s decision-making and experiences in accessing abortion.

Methods

Between April 2017 and February 2018 we interviewed 30 women living in Northern Ireland who had sought abortion by travelling to a clinic in Great Britain or by using online telemedicine to self-manage a medication abortion at home. We interviewed women both before and after a policy change that allowed women from Northern Ireland access to free abortion services in Great Britain. We used a semi-structured in-depth approach and analysed the interviews using grounded theory methodology to identify key themes.

Results

Four key findings emerged from our analysis: (1) women experience multiple barriers to travelling for abortion services, even when abortion is provided without charge; (2) self-management is often preferred over travel, but its criminalisation engenders fear and isolation; (3) obstruction of import of abortion medications by Northern Ireland Customs contributes to stress, anxiety, a higher risk of complications, and trial of ineffective or unsafe methods; and (4) lack of clarity surrounding the obligations of healthcare professionals in Northern Ireland causes mistrust of the healthcare system.

Conclusions

Northern Ireland’s abortion laws negatively affect the quality and safety of women’s healthcare and can have serious implications for women’s physical and emotional health. Our findings offer new perspectives for the current policy debate over Northern Ireland’s abortion laws and suggest a public health rationale for decriminalising abortion.