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Cryopreserved human skin allografts promote angiogenesis and dermal regeneration in a murine model

Abstract

Cryopreserved human skin allografts (CHSAs) are used for the coverage of major burns when donor sites for autografts are insufficiently available and have clinically shown beneficial effects on chronic non‐healing wounds. However, the biologic mechanisms behind the regenerative properties of CHSA remain elusive. Furthermore, the impact of cryopreservation on the immunogenicity of CHSA has not been thoroughly investigated and raised concerns with regard to their clinical application. To investigate the importance and fate of living cells, we compared cryopreserved CHSA with human acellular dermal matrix (ADM) grafts in which living cells had been removed by chemical processing. Both grafts were subcutaneously implanted into C57BL/6 mice and explanted after 1, 3, 7, and 28 days (n = 5 per group). A sham surgery where no graft was implanted served as a control. Transmission electron microscopy (TEM) and flow cytometry were used to characterise the ultrastructure and cells within CHSA before implantation. Immunofluorescent staining of tissue sections was used to determine the immune reaction against the implanted grafts, the rate of apoptotic cells, and vascularisation as well as collagen content of the overlaying murine dermis. Digital quantification of collagen fibre alignment on tissue sections was used to quantify the degree of fibrosis within the murine dermis. A substantial population of live human cells with intact organelles was identified in CHSA prior to implantation. Subcutaneous pockets with implanted xenografts or ADMs healed without clinically apparent rejection and with a similar cellular immune response. CHSA implantation largely preserved the cellularity of the overlying murine dermis, whereas ADM was associated with a significantly higher rate of cellular apoptosis, identified by cleaved caspase‐3 staining, and a stronger dendritic cell infiltration of the murine dermis. CHSA was found to induce a local angiogenic response, leading to significantly more vascularisation of the murine dermis compared with ADM and sham surgery on day 7. By day 28, aggregate collagen‐1 content within the murine dermis was greater following CHSA implantation compared with ADM. Collagen fibre alignment of the murine dermis, correlating with the degree of fibrosis, was significantly greater in the ADM group, whereas CHSA maintained the characteristic basket weave pattern of the native murine dermis. Our data indicate that CHSAs promote angiogenesis and collagen‐1 production without eliciting a significant fibrotic response in a xenograft model. These findings may provide insight into the beneficial effects clinically observed after treatment of chronic wounds and burns with CHSA.

The interplay between mindfulness, depression, stress and academic performance in medical students: A Saudi perspective

by Ahmed M. Alzahrani, Ahmed Hakami, Ahmad AlHadi, Mohammed A. Batais, Abdullah A. Alrasheed, Turky H. Almigbal

There is a growing body of research that shows a significant association between mindfulness and mental health. However, studies on Saudi populations are still in their infancy. Mindfulness is a personal tendency to focus on the present time in a non-judgmental manner, including the interior and exterior experience of feelings and events. The first aim of this study is to examine the relationship between mindfulness, stress, depression, and academic performance in a sample of medical students from King Saud University. The second aim is to explore the potential moderation effects of mindfulness on the impact of stress on academic performance and depression in the study population. This cross-sectional study examined 289 medical students who were selected by a stratified random sampling technique and completed validated online questionnaires measuring mindfulness, stress, and depression. The data were analyzed using SAS version 9.2, and R software was used for graphs. Correlation analysis showed that mindfulness is inversely associated with depression and stress, but not with academic performance. Furthermore, multiple logistic regression showed that mindfulness can predict both depression and stress. We also found that two subscales of mindfulness can moderate the relation between stress and depression: non-judging of inner experience and describing. The findings suggest that a higher mindfulness score is associated with lower depression and stress levels and could buffer against depression in a stressful environment. There is a need for further research to investigate the relation of mindfulness with positive psychological outcomes, as well as experimental trials to examine the efficacy of mindfulness training on improving mental wellbeing in our community.

Physical prognostic factors predicting outcome following anterior cruciate ligament reconstruction: protocol for a systematic review

Por: Middlebrook · A. · Bekker · S. · Middlebrook · N. · Rushton · A. B.
Introduction

Injuries of the anterior cruciate ligament (ACL) are a common musculoskeletal complication and can cause significant reduction in patient function and quality of life. Many undergo ACL reconstruction, with high-quality rehabilitation key to successful outcome. Knowledge of physical prognostic factors, such as quadriceps strength, is crucial to inform rehabilitation and has important implications for outcome following ACL reconstruction. However, these factors predicting outcome are poorly defined. Therefore, the aim of this systematic review is to establish physical prognostic factors predictive of outcome in adults following ACL reconstruction. Outcome will be subdivided into two groups of outcome measures, patient-reported and performance-based. Physical prognostic factors of interest will reflect a range of domains and may be modifiable/non-modifiable. Results will help decide most appropriate management and assist in planning and tailoring preoperative and postoperative rehabilitation.

Methods and analysis

This systematic review protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. MEDLINE, CINAHL and EMBASE databases, key journals and grey literature will be searched from inception to July 2019. Prospective cohort studies including participants aged ≥16 years who have undergone ACL reconstruction will be included, with articles focusing on multi-ligament reconstructions and ACL repair surgery, or not published in English excluded. Two independent reviewers will conduct searches, assess study eligibility, extract data, assess risk of bias (Quality in Prognostic Studies tool) and quantify overall quality of evidence (modified Grading of Recommendations, Assessment, Development and Evaluation guidelines). If possible, a meta-analysis will be conducted, otherwise a narrative synthesis will ensue focusing on prognostic factors, risk of bias of included studies and strength of association with outcomes.

Ethics and dissemination

Findings will be published in a peer-reviewed journal, presented at conferences and locally to physiotherapy departments. Ethical approval is not required for this systematic review.

PROSPERO registration number

CRD42019127732.

Severe Asthma Toolkit: an online resource for multidisciplinary health professionals--needs assessment, development process and user analytics with survey feedback

Por: Maltby · S. · Gibson · P. G. · Reddel · H. K. · Smith · L. · Wark · P. A. B. · King · G. G. · Upham · J. W. · Clark · V. L. · Hew · M. · Owens · L. · Oo · S. · James · A. L. · Thompson · B. · Marks · G. B. · McDonald · V. M.
Objectives

Severe asthma imposes a significant burden on individuals, families and the healthcare system. New treatment and management approaches are emerging as effective options for severe asthma. Translating new knowledge to multidisciplinary healthcare professionals is a priority. We developed ‘The Severe Asthma Toolkit’ (https://toolkit.severeasthma.org.au) to increase awareness of severe asthma, provide evidence-based resources and support decisionmaking by healthcare providers.

Setting

Roundtable discussions and a survey of Australians clinicians were conducted to determine clinician preferences, format and content for a severe asthma resource.

Participants

A reference group from stakeholder and consumer bodies and severe asthma experts provided advice and feedback. A multidisciplinary team of international experts was engaged to develop content. Written content was based on up-to-date literature. Peer and editorial review were performed to finalise content and inform web design. Website design focused on user experience, navigation, engagement, interactivity and tailoring of content for a clinical audience.

Results

A web-based resource was developed. Roundtable discussions and a needs assessment survey identified the need for dedicated severe asthma management resources to support skills training. The end-product, which launched 26 March 2018, includes an overview of severe asthma, diagnosis and assessment, management, medications, comorbidities, living with severe asthma, establishing a clinic, paediatrics/adolescents and clinical resources. Analytics indicate access by users worldwide (32 169 users from 169 countries). User survey results (n=394) confirm access by the target audience (72% health professionals), who agreed the toolkit increased their knowledge (73%) and confidence in managing severe asthma (66%), and 75% are likely to use the resource in clinic.

Conclusions

The Severe Asthma Toolkit is a unique, evidence-based internet resource to support healthcare professionals providing optimal care for people with severe asthma. It is a comprehensive, accessible and independent resource developed by leading severe asthma experts to improve clinician knowledge and skills in severe asthma management.

Determinants of overweight/obesity among reproductive age group women in Ethiopia: multilevel analysis of Ethiopian demographic and health survey

Por: Yeshaw · Y. · Kebede · S. A. · Liyew · A. M. · Tesema · G. A. · Agegnehu · C. D. · Teshale · A. B. · Alem · A. Z.
Objective

Overweight/obesity among women is associated with an increased risk of gestational diabetes, pre-eclampsia, postpartum haemorrhage, low birth weight, congenital malformation and neonatal deaths. Although the magnitude of overweight and obesity among the reproductive age group women is a common problem in Ethiopia, there are limited studies that determine the associated factors of overweight and obesity at the national level. Therefore, this study aimed to identify the determinant factors of overweight/obesity among reproductive age group women in Ethiopia.

Design

Cross-sectional study design.

Setting

Ethiopia.

Participants

Non-pregnant women aged 15–49 years.

Primary outcome

Overweight/obesity.

Methods

The present study used the Ethiopia Demographic Health Survey (EDHS) data for 2016. A total of 10 938 non-pregnant reproductive age group women were included in the analysis. Both bivariable and multivariable multilevel logistic regression were performed to determine the determinants of overweight and obesity among women in Ethiopia. The OR with a 95% CI was estimated for potential determinants included in the final model.

Results

Those women with secondary education (adjusted OR (AOR)=1.48, 1.01, 2.18), higher education (AOR=1.78, 1.13, 2.81), richer (AOR=1.85, 1.15, 2.98) and richest wealth index (AOR=3.23, 1.98, 5.29), urban residence (AOR=4.46, 2.89, 6.87), married (AOR=1.79, 1.21, 2.64), widowed (AOR=2.42, 1.41, 4.15), divorced (AOR=1.84, 1.13, 3.00), aged 25–34 years (AOR=2.04, 1.43, 2.89), 35–44 years (AOR=2.79, 1.99, 3.93) and 45–49 years (AOR=2.62, 1.54, 4.45) had higher odds of developing overweight and obesity.

Conclusion

Women with higher education level, high wealth status, older age, formerly married and those urban dwellers had higher odds of overweight and obesity. Therefore, regular physical activity, reducing consumption of fat/energy-dense food as well as modifying the mode of transportation is recommended.

Infection in neuro‐muscular scoliosis deformity correction

Abstract

Assess the outcome of a standardised protocol for the treatment of post‐operative wound infection in patients undergoing deformity correction for neuro‐muscular scoliosis (NMS). Retrospective review of 443 consecutive patients with a minimum 18 months’ follow‐up, following a primary posterior deformity correction for NMS. In patients who developed a wound complication, the patient demographic and comorbidities, causative pathogen, number of re‐operations, length of stay (LOS), rate of cure, and complications were analysed. Forty‐four patients (9.9%) developed a wound infection. Marginally more infections were mono‐microbial (23) than poly‐microbial (21). Coagulase negative staphylococcus and Staphylococcus aureus were the most commonly cultured pathogens. Seventeen patients were treated with antibiotics alone, while 27 patients also required surgical debridement. The average LOS for those treated with antibiotics alone was 12 days (range: 9‐15 days), in contrast to those requiring debridement, which was 35 days (range: 35‐70 days). All patients were cured from their infection and ultimately achieved fusion. Infection is common in NMS deformity correction. This is marginally more common as a mono‐microbial than poly‐microbial infection with most pathogens being staphylococcal in origin. Our defined treatment strategy resulted in a cure for all patients and capacity for all patients to achieve fusion.

Clinical indicators to identify neuropathic pain in low back-related leg pain: protocol for a modified Delphi study

Por: Mistry · J. · Falla · D. · Noblet · T. · Heneghan · N. R. · Rushton · A. B.
Introduction

Neuropathic low back-related leg pain (LBLP) can be a challenge to healthcare providers to diagnose and treat. Accurate diagnosis of neuropathic pain is fundamental to ensure appropriate intervention is given. However, to date there is no gold standard to diagnose neuropathic LBLP. A Delphi study will therefore be conducted to obtain an expert-derived consensus list of clinical indicators to identify a neuropathic component to LBLP.

Methods/analysis

Included participants will be considered experts within the field as measured against a predefined eligibility criterion. Through an iterative multistage process, participants will rate their agreement with a list of clinical indicators and suggest any missing clinical indicators during each round. Agreement will be measured using a 5-point Likert scale. Descriptive statistics will be used to measure agreement; median, IQR and percentage of agreement. A priori consensus criteria will be defined for each round. Data analysis at the end of round three will enable a list of clinical indicators to be derived.

Ethics and dissemination

Ethical approval was gained from the University of Birmingham (ERN_19-1142). On completion of the study, findings will be disseminated in a peer-reviewed journal and presented at relevant conferences.

Neighbourhood socioeconomic status modifies the association between anxiety and depression during pregnancy and preterm birth: a Community-based Canadian cohort study

Por: Adhikari · K. · Patten · S. B. · Williamson · T. · Patel · A. B. · Premji · S. · Tough · S. · Letourneau · N. · Giesbrecht · G. · Metcalfe · A.
Objective

This study examined the association of anxiety alone, depression alone and the presence of both anxiety and depression with preterm birth (PTB) and further examined whether neighbourhood socioeconomic status (SES) modified this association.

Design

Cohort study using individual-level data from two community-based prospective pregnancy cohort studies (All Our Families; AOF) and Alberta Pregnancy Outcomes and Nutrition (APrON) and neighbourhood SES data from the 2011 Canadian census.

Setting

Calgary, Alberta, Canada.

Participants

Overall, 5538 pregnant women who were 15 years old were enrolled in the cohort studies between 2008 and 2012. 3341 women participated in the AOF study and 2187 women participated in the APrON study, with 231 women participated in both studies. Women who participated in both studies were only counted once.

Primary and secondary outcome measures

PTB was defined as delivery prior to 37 weeks of gestation. Depression was defined as an Edinburgh Postnatal Depression Scale (EPDS) score of ≥13, anxiety was defined as an EPDS-anxiety subscale score of ≥6, and the presence of both anxiety and depression was defined as meeting both anxiety and depression definitions.

Results

Overall, 7.3% of women delivered preterm infants. The presence of both anxiety and depression, but neither of these conditions alone, was significantly associated with PTB (OR 1.6, 95% CI 1.1 to 2.3) and had significant interaction with neighbourhood deprivation (p=0.004). The predicted probability of PTB for women with both anxiety and depression was 10.0%, which increased to 15.7% if they lived in the most deprived neighbourhoods and decreased to 1.4% if they lived in the least deprived neighbourhoods.

Conclusions

Effects of anxiety and depression on risk of PTB differ depending on where women live. This understanding may guide the identification of women at increased risk for PTB and allocation of resources for early identification and management of anxiety and depression.

Factors associated with workarounds in barcode‐assisted medication administration in hospitals

Abstract

Aims and objectives

To identify that workarounds (defined as “informal temporary practices for handling exceptions to normal procedures or workflow”) by nurses using information technology potentially compromise medication safety. Therefore, we aimed to identify potential risk factors associated with workarounds performed by nurses in Barcode‐assisted Medication Administration in hospitals.

Background

Medication errors occur during the prescribing, distribution and administration of medication. Errors could harm patients and be a tragedy for both nurses and medical doctors involved. Interventions to prevent errors have been developed, including those based on information technology. To cope with shortcomings in information technology‐based interventions as Barcode‐assisted Medication Administration, nurses perform workarounds. Identification of workarounds in information technology is essential to implement better‐designed software and processes which fit the nurse workflow.

Design

We used the data from our previous prospective observational study, performed in four general hospitals in the Netherlands using Barcode techniques, to administer medication to inpatients.

Methods

Data were collected from 2014–2016. The disguised observation was used to gather information on potential risk factors and workarounds. The outcome was a medication administration with one or more workarounds. Logistic mixed models were used to determine the association between potential risk factors and workarounds. The STROBE checklist was used for reporting our data.

Results

We included 5,793 medication administrations among 1,230 patients given by 272 nurses. In 3,633 (62.7%) of the administrations, one or more workarounds were observed. In the multivariate analysis, factors significantly associated with workarounds were the medication round at 02 p.m.–06 p.m. (adjusted odds ratio [OR]: 1.60, 95% CI: 1.05–2.45) and 06 p.m.–10 p.m. (adjusted OR: 3.60, 95% CI: 2.11–6.14) versus the morning shift 06 a.m.–10 a.m., the workdays Monday (adjusted OR: 2.59, 95% CI: 1.51–4.44), Wednesday (adjusted OR: 1.92, 95% CI: 1.2–3.07) and Saturday (adjusted OR: 2.24, 95% CI: 1.31–3.84) versus Sunday, the route of medication, nonoral (adjusted OR: 1.28, 95% CI: 1.05–1.57) versus the oral route of drug administration, the Anatomic Therapeutic Chemical classification‐coded medication “other” (consisting of the irregularly used Anatomic Therapeutic Chemical classes [D, G, H, L, P, V, Y, Z]) (adjusted OR: 1.49, 95% CI: 1.05–2.11) versus Anatomic Therapeutic Chemical class A (alimentary tract and metabolism), and the patient–nurse ratio ≥6–1 (adjusted OR: 5.61, 95% CI: 2.9–10.83) versus ≤5–1.

Conclusions

We identified several potential risk factors associated with workarounds performed by nurses that could be used to target future improvement efforts in Barcode‐assisted Medication Administration.

Relevance to clinical practice

Nurses administering medication in hospitals using Barcode‐assisted Medication Administration frequently perform workarounds, which may compromise medication safety. In particular, nurse workload and the patient–nurse ratio could be the focus for improvement measures as these are the most clearly modifiable factors identified in this study.

Development and content validation of the Burden of Documentation for Nurses and Midwives (BurDoNsaM) survey 护士和助产士文件记载负担调查的开展和内容验证

Abstract

Aim

To develop a validated tool to measure nursing and midwifery documentation burden.

Background

While an important record of care, documentation can be burdensome for nurses and midwives and may remove them from direct patient care, resulting in decreased job satisfaction, associated with decreased patient satisfaction. The amount of documentation is increasing at a time where staff rationalisation results in decreasing numbers of clinicians at the bedside. No instrument is available to measure staff perceptions of the burden of clinical documentation.

Design

Survey development, followed by rwo rounds of content validation (April and May 2019).

Methods

Based on the literature a 28 item survey, with items in 6 subscales, representing key areas of documentation burden was developed. Item (I‐CVI), subscale (S‐CVI/Ave by subscale) and overall content validity indexes (S‐CVI/Ave) were calculated following two review rounds by an expert panel of clinical and academic nurses and midwives.

Results

Level of agreement for the first iteration of the survey was low, with many items failing to reach the critical I‐CVI threshold of 0.78. No subscale reached a S‐CVI/Ave above 0.8 and the overall scale only achieved a S‐CVI/Ave score of 0.67. Thirteen items were removed, seven were edited and five new items added, based on the expert panel feedback, substantially improving the content validity. All individual items achieved an I‐CVI ≥0.78, the S‐CVI/Ave was above 0.85 for all subscales and the total S‐CVI/Ave was 0.94.

Conclusion

The Burden of Documentation for Nurses and Midwives (BurDoNsaM) survey can be considered as content valid, according to the content validity analysis by an expert panel.

Impact

The BurDoNsaM survey may be used by nurse leaders and researchers to measure the burden of documentation, providing the opportunity to review practice and implement strategies to decrease documentation burden, potentially improving patient satisfaction with the care received.

目的

开发有效工具来衡量护理和助产工作的文件记载负担。

背景

虽然文件记载属于一项重要的护理记录工作,但其对护士和助产士来说可能很麻烦,并可能会使他们脱离直接的病人护理,导致工作满意度降低,进而病人满意度下降。在人员合理化导致病床临床医师人数减少的情况下,文件记载数量正在增加。尚无任何工具可用来衡量人员对临床文件记载负担的看法。

设计

调查开展,然后进行两轮内容验证(2019年4月和5月)。

方法

根据文献资料,采用6个分量表的条目,对文件记载负担的重要方面展开28个条目的调查。经临床和学术护士及助产士组成的专家小组进行两轮评估后,对条目(I‐CVI)、分量表(根据分量表的平均S‐CVI)以及总体的内容效度指数(平均S‐CVI)进行了计算。

结果

调查的首次迭代的一致性水平较低,许多条目未能达到I‐CVI 临界值0.78。所有分量表的平均S‐CVI均未达到0.8以上,总体量表的平均S‐CVI得分仅为0.67。根据专家组的反馈意见,删除了13个条目,编辑了7个条目,并增加了5个新条目,大大提高了内容效度。所有单个条目的I‐CVI均在0.78以上(含),各分量表的平均S‐CVI均在0.85以上,总体平均S‐CVI为0.94。

结论

根据专家组对内容效度的分析,护士和助产士文件记载负担调查可视为内容有效。

影响

护理组长和研究人员可使用护士和助产士文件记载负担调查来衡量文件记载的负担,提供机会来评估实践以及实施减轻文件记载负担的策略,从而有可能提高患者对所接受护理的满意度。

Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol

Por: Bekelman · J. E. · Lu · H. · Pugh · S. · Baker · K. · Berg · C. D. · de Gonzalez · A. B. · Braunstein · L. Z. · Bosch · W. · Chauhan · C. · Ellenberg · S. · Fang · L. C. · Freedman · G. M. · Hahn · E. A. · Haffty · B. G. · Khan · A. J. · Jimenez · R. B. · Kesslering · C. · Ky · B. · Lee · C
Introduction

A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer.

Methods

We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events.

Ethics and dissemination

The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.

Trial registration number

NCT02603341

Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol

Por: Wiangkham · T. · Uthaikhup · S. · Rushton · A. B.
Introduction

Non-specific neck pain causes pain and disability and contributes substantial socioeconomic burden internationally. Up to 50% of adults experience neck pain annually, leading to reduced the quality of life. An active behavioural physiotherapy intervention (ABPI) may be feasible to manage patients with acute non-specific neck pain to prevent transition to chronicity. A recent pilot and feasibility trial investigating an acute whiplash-associated disorder population found potential value of the ABPI with 95% of participants fully recovered (Neck Disability Index: NDI ≤4, compared with 17% in the standard physiotherapy arm); supporting a definitive trial. Qualitative findings from the physiotherapists supported the potential of the ABPI in a non-specific neck pain population.

Methods and analysis

Two phases: (1) Pragmatic cluster randomised double-blind, parallel 2-arm (ABPI vs standard physiotherapy intervention) pilot and feasibility trial to evaluate the procedures and feasibility of the ABPI for the management of acute non-specific neck pain. Six physiotherapy departments from six public hospitals in Thailand will be recruited and cluster randomised by a computer-generated randomisation sequence with block sampling. Sixty participants (30 each arm, 10 per hospital) will be assessed at baseline and 3 months following baseline for NDI, Numerical Rating Scale for pain intensity, cervical range of motion, fear-avoidance beliefs questionnaire and EuroQol-5 dimensions 5 levels outcomes, and (2) Embedded qualitative study using semistructured interviews to explore acceptability of the ABPI to participants (n=12) and physiotherapists (n=3). Descriptive analysis of the quantitative data and interpretative phenomenological analysis to code and analyse qualitative data (deductive and inductive) will inform feasibility for a future definitive trial.

Ethics and dissemination

This trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).

Trial registration number and status

TCTR20180607001; Recruiting commenced 1 February 2019.

Prospective longitudinal study of tobacco company adaptation to standardised packaging in the UK: identifying circumventions and closing loopholes

Por: Evans-Reeves · K. A. · Hiscock · R. · Lauber · K. · Gilmore · A. B.
Objectives

UK standardised packaging legislation was introduced alongside pack size and product descriptor restrictions of the European Union Tobacco Products Directive to end tobacco marketing and misinformation via the pack. This paper aims to assess compliance with the restrictions and identify attempts to continue to market tobacco products and perpetuate misperceptions of harm post legislation.

Design, setting and intervention

A prospective study of the introduction of standardised packaging of tobacco products to the UK.

Participants and outcomes

We analysed commercial sales data to assess whether the legally required changes in pack branding, size and name were implemented. To explore any adaptations to products and packaging we analysed sales data, monthly pack purchases of factory-made (FM) cigarettes and roll-your-own (RYO) tobacco, tobacco advertisements from retail trade magazines and articles on tobacco from commercial literature (retail trade, market analyst and tobacco company publications).

Results

One month after full implementation of the UK and European Union policies, 97% FM and 98% RYO was sold in compliant packaging. Nevertheless, tobacco companies made adaptations to tobacco products which enabled continued brand differentiation after the legislation came into force. For example, flavour names previously associated with low tar were systematically changed to colour names arguably facilitating continued misperceptions about the relative harms of products. Tobacco companies used the 1-year sell-through to their advantage by communicating brand name changes and providing financial incentives for retailers to buy large volumes of branded packs. In addition, tobacco companies continued to market their products to retailers and customers by innovating exemptions to the legislation, namely, filters, packaging edges, seals, multipack outers, RYO accessories, cigars and pipe tobacco.

Conclusions

Tobacco companies adapted to packaging restrictions by innovating their tobacco products and marketing activities. These findings should enable policy makers globally to close loopholes and increase the potential efficacy of standardised packaging policies.

Adaptation and Implementation of a Family Caregiver Skills Training Program: From Single Site RCT to Multisite Pragmatic Intervention

Abstract

Purpose

We describe an approach to rapidly adapt and implement an education and skills improvement intervention to address the needs of family caregivers of functionally impaired veterans—Helping Invested Families Improve Veterans’ Experience Study (HI‐FIVES).

Design

Prior to implementation in eight sites, a multidisciplinary study team made systematic adaptations to the curriculum content and delivery process using input from the original randomized controlled trial (RCT); a stakeholder advisory board comprised of national experts in caregiver education, nursing, and implementation; and a veteran/caregiver engagement panel. To address site‐specific implementation barriers in diverse settings, we applied the Replicating Effective Programs implementation framework.

Findings

Adaptations to HI‐FIVES content and delivery included identifying core/noncore curriculum components, reducing instruction time, and simplifying caregiver recruitment for clinical settings. To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely. Curriculum materials were standardized and packaged to reduce the time required for implementation and to promote fidelity to the intervention.

Conclusions

The emphasis on flexible intervention delivery and standardized materials has been identified as strengths of the adaptation process. Two key challenges have been identifying feasible impact measures and reaching eligible caregivers for intervention recruitment.

Clinical Relevance

This systematic implementation process can be used to rapidly adapt an intervention to diverse clinical sites and contexts. Nursing professionals play a significant role in educating and supporting caregivers and care recipients and can take a leading role to implement interventions that address skills and unmet needs for caregivers.

The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study

Por: Corcoran · T. B. · Myles · P. S. · Forbes · A. B. · O'Loughlin · E. · Leslie · K. · Story · D. · Short · T. G. · Chan · M. T. · Coutts · P. · Sidhu · J. · Cheng · A. C. · Bach · L. A. · Ho · K. M. · on behalf of the Australian and New Zealand College of Anaesthetists Clinical Tri
Introduction

The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.

Methods/analysis

This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.

Ethics/dissemination

The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.

Trial registration number

ACTRN12614001226695.

Out-of-sequence DTP and measles vaccinations and child mortality in Guinea-Bissau: a reanalysis

Por: Thysen · S. M. · Rodrigues · A. · Aaby · P. · Fisker · A. B.
Objectives

To assess whether the sequence of diphtheria-tetanus-pertussis vaccine (DTP) and measles vaccine (MV) was associated with child survival in a dataset previously used to assess non-specific effects of vaccines with no consideration of vaccination sequence.

Design

Prospective cohort study analysed using the landmark approach.

Setting

Bandim Health Project’s Health and Demographic Surveillance System covering 100 village clusters in rural Guinea-Bissau. The recommended vaccination schedule was BCG and oral polio vaccine (OPV) at birth, DTP and OPV at 6, 10 and 14 weeks, MV at 9 months and booster DTP and OPV at 18 months of age.

Participants

Children aged 9–17 months (main analysis) and 18–35 months (secondary analysis: age of booster DTP) with vaccination status assessed between April 1991 and April 1996.

Methods

Survival during the 6 months after assessing vaccination status was compared by vaccination sequence in Cox-proportional hazards models with age as underlying time. Analyses were stratified by sex and village cluster.

Main outcome measure

Mortality rate ratio (MRR) for out-of-sequence vaccinations compared with in-sequence vaccinations.

Results

Among children aged 9–17 months, 60% of observations (3574/5937) were from children who had received both MV and DTP. Among these, 1590 observations were classified as in-sequence vaccinations (last DTP before MV), and 1984 observations were out-of-sequence vaccinations (1491: MV with DTP and 493: MV before DTP). Out-of-sequence vaccinations were associated with higher mortality than in-sequence vaccinations (MRR 2.10, 95% CI 1.07 to 4.11); the MRR was 2.30 (95% CI 1.15 to 4.58) for MV with DTP and 1.45 (95% CI 0.50 to 4.22) for DTP after MV. Associations were similar for boys and girls (p=0.77). Between 18 and 35 months the mortality rate increased among children vaccinated in-sequence and the differential effect of out-of-sequence vaccinations disappeared.

Conclusion

Out-of-sequence vaccinations may increase child mortality. Hence, sequence of vaccinations should be considered when planning vaccination programmes or introducing new vaccines into the current vaccination schedule.

Rationale and design of a statewide telestroke registry: Lone Star Stroke Consortium Telestroke Registry (LeSteR)

Por: Astudillo · C. · Ankrom · C. · Trevino · A. · Malazarte · R. M. · Bambhroliya · A. B. · Savitz · S. · Topel · C. H. · Milling · T. J. · Wu · T.-C.
Introduction

The Lone Star Stroke Consortium Telestroke Registry (LeSteR) currently consisting of 3 academic hub centres and 27 partner spokes is a statewide initiative organised by leading academic health centres in the State of Texas to understand practice patterns of acute stroke management via telestroke (TS) in Texas, a state with one of the largest rural populations in the USA.

Methods and analysis

All patients who had presumed stroke for whom a TS consultation has been obtained in the network are entered into a web-based, Health Insurance Portability and Accountability Act-compliant database from September 2013 to present. Spokes were enrolled into LeSteR in a staggered approach in two data collection phases: a retrospective phase and a prospective phase. Basic clinical, demographic data and relevant time metrics are collected in the retrospective phase. Starting 1 September 2015, additional outcome data including 90-day modified Rankin score, readmission and 90-day disposition are obtained by a standard phone interview. From the registry initiation to 31 December 2017, there are 8089 patients who had suspected stroke in the registry. Over 60% of patients enrolled after 1 September 2015 have reported outcome data. Enrolment is still active for this registry.

Ethics and dissemination

LeSteR is a statewide TS registry organised by academic health centres that will provide significant insight regarding the impact of TS in the State of Texas. Findings from LeSteR will provide data that can be analysed to improve the allocation of healthcare resources using TS to treat stroke in a state with one of the largest rural populations.

Characterisation of the fibroinflammatory process involved in progression from acute to chronic pancreatitis: study protocol for a multicentre, prospective cohort study

Por: Novovic · S. · Borch · A. · Werge · M. · Karran · D. · Gluud · L. · Schmidt · P. N. · Hansen · E. F. · Nojgaard · C. · Jensen · A. B. · Jensen · F. K. · Frokjaer · J. B. · Hansen · M. B. · Jorgensen · L. N. · Drewes · A. M. · Olesen · S. S.
Introduction

Chronic pancreatitis (CP) is thought to present the end stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent AP, to early and end-stage CP. Due to the irreversible nature of CP, early detection and prevention is key. Prospective assessment based on advanced imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress may provide a better understanding of the underlying pathological processes and help identify novel biomarkers of disease with the ultimate goal of early diagnosis, intervention and prevention of disease progression. This paper describes the protocol of a prospective multicentre cohort study investigating the fibroinflammatory process involved in progression from acute to CP using state-of-the-art diagnostic imaging modalities and circulating biomarkers of inflammation, fibrosis and oxidative stress.

Methods and analysis

Adult control subjects and patients at different stages of CP according to the M-ANNHEIM system will be recruited from outpatient clinics at the participating sites and form three cohorts: controls (n=40), suspected CP (n=60) and definitive CP (n=60). Included patients will be followed prospectively for 15 years with advanced MRI and contrast-enhanced endoscopic ultrasound with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood samples for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential circulating biomarkers of disease progression, including markers of inflammation, fibrosis and oxidative stress.

Ethics and dissemination

Permissions from the Regional Science Ethics committee and the Regional Data Protection Agency have been obtained. We will submit the results of the study for publication in peer-reviewed journals regardless of whether the results are positive, negative or inconclusive.

Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY): an open-label, randomised, non-inferiority clinical trial

Por: Paez-Vega · A. · Cantisan · S. · Vaquero · J. M. · Vidal · E. · Luque-Pineda · A. · Lobo-Acosta · M. A. · Perez · A. B. · Alonso-Moralejo · R. · Iturbe · D. · Monforte · V. · Otero-Gonzalez · I. · Pastor · A. · Ussetti · P. · Torre-Cisneros · J.
Introduction

Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.

Methods and analysis

Phase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study.

Ethics and public dissemination

The clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).

If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients.

Trial registration number

NCT03699254.

Patient journey following lumbar discectomy surgery: protocol for a single-centre qualitative analysis of the patient rehabilitation experience (DiscJourn)

Por: White · L. · Heneghan · N. R. · Furtado · N. · Masson · A. · Rushton · A. B.
Introduction

Lumbar discectomy is a widely used surgical procedure internationally with the majority of patients experiencing significant benefit. However, approximately 20% of patients report suboptimal functional recovery and quality of life. The impact and meaning of the surgical experience from the patients’ perspective are not fully understood. Furthermore, there is limited evidence guiding postoperative management with significant clinical practice variation and it is unclear if current postoperative support is valued, beneficial or meets patients’ needs and expectations. This study aims to address the evidence gap by moving beyond current knowledge to gain insight into the lived experiences relating to patients’ lumbar discectomy surgery journey. Results will inform more meaningful and specific care, thus, enhance rehabilitation and outcomes.

Methods and analysis

A qualitative investigation using interpretative phenomenology analysis (IPA) will provide a flexible inductive research approach. A purposive sample (n=20) of patients undergoing primary discectomy will be recruited from one UK NHS secondary care centre. Semi-structured interviews will be conducted postsurgery discharge. A topic guide, developed from the literature and our previous work with input from two patient co-investigators, will guide interviews with the flexibility to explore interesting or patient-specific points raised. Providing longitudinal data, patients will keep weekly diaries capturing experiences and change over time throughout 12 months following surgery. A second interview will be completed 1 year postsurgery with its topic guide informed by initial findings. This combination of patient interviews and diaries will capture patients’ attitudes and beliefs regarding surgery and recovery, facilitators and barriers to progress, experiences regarding return to activities/function and interactions with healthcare professionals. The rich density of data will be thematically analysed in accordance with IPA, supported by NVivo software.

Ethics and dissemination

Ethical approval has been granted by the London-Bloomsbury Research Ethics Committee (18/LO/0459; IRAS 241345). Conclusions will be disseminated through conferences and peer-reviewed journals.

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