bluuebunny/crossref_metadata_2025 huggingface dataset:
Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study
Authors: Østengaard Lasse , Lundh Andreas , Tjørnhøj-Thomsen Tine , Abdi Suhayb , Gelle Mustafe H A , Stewart Lesley A , Boutron Isabelle , Hróbjartsson Asbjørn
Published: October 2020

Objective

To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally.

Design

Qualitative interview study.

Participants

Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed.

Setting

Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest.

Results

The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage.

Conclusion

This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers’ understanding of what conflicts of interest are and when they should be reported.
What is considered as global health scholarship? A meta-knowledge analysis of global health journals and definitions
Authors: Abdalla Salma M , Solomon Hiwote , Trinquart Ludovic , Galea Sandro
Published: October 2020

Despite the rapid growth of the global health field over the past few decades, consensus on what qualifies as global health scholarship or practice remains elusive. We conducted a meta-knowledge analysis of the titles and abstracts of articles published in 25 journals labelled as global health journals between 2001 and 2019. We identified the major topics in these journals by creating clusters based on terms co-occurrence over time. We also conducted a review of global health definitions during the same period.

The analysis included 16 413 articles. The number of journals, labelled as global health, and articles published in these journals, increased dramatically during the study period. The majority of global health publications focused on topics prevalent in low-resource settings. Governance, infectious diseases, and maternal and child health were major topics throughout the analysis period. Surveillance and disease outcomes appeared during the 2006–2010 epoch and continued, with increasing complexity, until the 2016–2019 epoch. Malaria, sexual and reproductive health, and research methodology appeared for only one epoch as major topics. We included 11 relevant definitions in this analysis. Definitions of global health were not aligned with the major topics identified in the analysis of articles published in global health journals.

These results highlight a lack of alignment between what is published as global health scholarship and global health definitions, which often advocate taking a global perspective to population health. Our analysis suggests that global health has not truly moved beyond its predecessor, international health. There is a need to define the parameters of the discipline and investigate the disconnect between what is published in global health versus how the field is defined.
Patient access to gene therapy medicinal products: a comprehensive review
Authors: Carvalho Marta , Sepodes Bruno , Martins Ana Paula
Published: October 2020

Background

Gene therapies have the potential to be a curative approach to a large number of genetic diseases. However, granting of a positive marketing authorisation does not equal patient access to therapy.

Objectives

The purpose of this paper is to identify a full set of hurdles potentially preventing patient access to gene therapies based on the available literature.

Methods

A review of the literature using systematic approach in two distinct databases was performed by identifying relevant, peer-reviewed publications, between 2012 and 2018.

Results

Seven major topics were identified as potential patient access hurdles, namely affordability, assessment of value, development of therapy, ethical/social factors, evidence generation, operational implementation and regulatory hurdles. From these, 25 additional subthemes were further identified. The most frequently mentioned obstacle in the literature is related to the affordability aspect especially focusing on high cost of therapy (84%) and therapy payment/reimbursement (51%). Importantly, the evidence generation focusing on limited trial outcomes (81%) seems as a strong obstacle in patient access to these therapies.

Conclusions

A growing number of gene therapies are expected to be developed and made available to patients and healthcare professionals. Improvement of patient access to gene therapies can only be achieved by understanding all hurdles, in a complete and integrated fashion, so that strategies are timely established to ensure gene therapies’ benefits are provided to patients and to the society.
Torso body armour coverage defined according to feasibility of haemorrhage control within the prehospital environment: a new paradigm for combat trauma protection
Authors: Breeze Johno , Bowley D M , Naumann D N , Marsden M E R , Fryer R N , Keene D , Ramasamy A , Lewis E A
Published: October 2020

Developments in military personal armour have aimed to achieve a balance between anatomical coverage, protection and mobility. When death is likely to occur within 60 min of injury to anatomical structures without damage control surgery, then these anatomical structures are defined as ‘essential’. However, the medical terminology used to describe coverage is challenging to convey in a Systems Requirements Document (SRD) for acquisition of new armour and to ultimately translate to the correct sizing and fitting of personal armour. Many of those with Ministry of Defence responsible for the procurement of personal armour and thereby using SRDs will likely have limited medical knowledge; therefore, the potentially complex medical terminology used to describe the anatomical boundaries must be translated into easily recognisable and measurable external landmarks. We now propose a complementary classification for ballistic protection coverage, termed threshold and objective, based on the feasibility of haemorrhage control within the prehospital environment.
Comparison of the costs of HPV testing through community health campaigns versus home-based testing in rural Western Kenya: a microcosting study
Authors: Olwanda Easter Elizabeth , Kahn James G , Choi Yujung , Islam Jessica Yasmine , Huchko Megan
Published: October 2020

Objectives

To estimate the cost of human papillomavirus (HPV)-based screening through community health campaigns (CHCs) and home-based testing.

Setting

CHCs and home-based testing in six communities in rural Western Kenya.

Participants

CHCs and home-based screening reached 2297 and 1002 women aged 25–65 years, respectively.

Outcome measures

Outcome measures were overall cost per woman screened achieved through the CHCs and home-based testing and the cost per woman for each activity comprising the screening intervention.

Results

The mean cost per woman screened through CHCs and home-based testing were similar, at $37.7 (range $26.4–$52.0) and $37.1 (range $27.6–$54.0), respectively. For CHCs, personnel represented 49% of overall cost, supplies 25%, services 5% and capital goods 23%. For home-based testing, these were: personnel 73%, supplies 25%, services 1% and capital goods 2%. A greater number of participants was associated with a lower cost per participant.

Conclusions

The mean cost per woman screened is comparable for CHC and home-based testing, with differences in type of input. The CHCs generally reached more eligible women in the six communities, whereas home-based strategies more efficiently reached populations with low screening rates.

Trial registration number

NCT02124252.
Translating new evidence into clinical practice: a quasi-experimental controlled before–after study evaluating the effect of a novel outreach mentoring approach on knowledge, attitudes and confidence of health workers providing HIV and infant feeding counselling in South Africa
Authors: Goga Ameena , Doherty Tanya , Manda Samuel , Nkwenika Tshifhiwa , Haskins Lyn , John Vaughn , Engebretsen Ingunn M S , Feucht Ute , Dhansay Ali , Rollins Nigel , Kroon Max , Sanders David , Kauchali Shuaib , Tylleskär Thorkild , Horwood Christiane
Published: October 2020

Objectives

We report the effectiveness of a mentoring approach to improve health workers’ (HWs’) knowledge, attitudes and confidence with counselling on HIV and infant feeding.

Design

Quasi-experimental controlled before–after study.

Setting

Randomly selected primary healthcare clinics (n=24 intervention, n=12 comparison); two districts, South Africa.

Participants

All HWs providing infant feeding counselling in selected facilities were invited.

Interventions

Three 1–2 hours, on-site workshops over 3–6 weeks.

Primary outcome measures

Knowledge (22 binary questions), attitude (21 questions—5-point Likert Scale) and confidence (19 questions—3-point Likert Scale). Individual item responses were added within each of the attitude and confidence domains. The respective sums were taken to be the domain composite index and used as a dependent variable to evaluate intervention effect. Linear regression models were used to estimate the mean score difference between intervention and comparison groups postintervention, adjusting for the mean score difference between them at baseline. Analyses were adjusted for participant baseline characteristics and clustering at health facility level.

Results

In intervention and comparison sites, respectively: 289 and 131 baseline and 253 and 114 follow-up interviews were conducted (August–December 2017). At baseline there was no difference in mean number of correctly answered knowledge questions; this differed significantly at follow-up (15.2 in comparison; 17.2 in intervention sites (p<0.001)). At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively). Controlling for confounders, interactions between time and intervention group and preintervention values, the attitude score was 5.1 points significantly higher in intervention versus comparison groups.

Conclusion

A participatory, low-intensity on-site mentoring approach to disseminating updated infant feeding guidelines improved HWs’ knowledge, attitudes and confidence more than standard dissemination via a circular. Further research is required to evaluate the effectiveness, feasibility and sustainability of this approach at scale.
Consequences of health condition labelling: protocol for a systematic scoping review
Authors: Sims Rebecca , Kazda Luise , Michaleff Zoe A , Glasziou Paul , Thomas Rae
Published: October 2020

Introduction

When health conditions are labelled it is often to classify and communicate a set of symptoms. While diagnostic labelling can provide explanation for an individual’s symptoms, it can also impact how individuals and others view those symptoms. Despite existing research regarding the effects of labelling health conditions, a synthesis of these effects has not occurred. We will conduct a systematic scoping review to synthesise the reported consequences and impact of being given a label for a health condition from an individual, societal and health practitioner perspective and explore in what context labelling of health conditions is considered important.

Methods and analysis

The review will adhere to the Joanna Briggs Methodology for Scoping Reviews. Searches will be conducted in five electronic databases (PubMed, Embase, PsycINFO, Cochrane, CINAHL). Reference lists of included studies will be screened and forward and backward citation searching of included articles will be conducted. We will include reviews and original studies which describe the consequences for individuals labelled with a non-cancer health condition. We will exclude hypothetical research designs and studies focused on the consequences of labelling cancer conditions, intellectual disabilities and/or social attributes. We will conduct thematic analyses for qualitative data and descriptive or meta-analyses for quantitative data where appropriate.

Ethics and dissemination

Ethical approval is not required for a scoping review. Results will be disseminated via publication in a peer-reviewed journal, conference presentations and lay-person summaries on various online platforms. Findings from this systematic scoping review will identify gaps in current understanding of how, when, why and for whom a diagnostic label is important and inform future research.
Awareness of cognitive abilities in the execution of activities of daily living after acquired brain injury: an evaluation protocol
Authors: Merchán-Baeza Jose Antonio , Rodriguez-Bailon Maria , Ricchetti Giorgia , Navarro-Egido Alba , Funes María Jesús
Published: October 2020

Introduction

One of the main limitations that can be observed after acquired brain injury (ABI) is the alteration of the awareness of the deficits that can occur in the cognitive skills necessary for performing activities of daily living (ADL). According to the Dynamic Comprehensive Model of Awareness (DCMA), consciousness is composed of offline component, which contains the information stored about characteristics of the tasks and stable beliefs about one’s own capabilities and online awareness, which is activated in the context of the performance of a specific task. The main objective of this project was to generate and validate a detailed cognitive assessment protocol within the context of ADL to evaluate the components of DCMA.

Methods and analysis

The proposed protocol consists of two ecological tools: The Cog-Awareness ADL Scale to measure offline component and the Awareness ADL-task: Basic and Instrumental ADL performance-based test to measure online awareness. The aim is to identify the presence of cognitive deficits and anosognosia in patients with ABI within the context of everyday life activities. These two measures will be administered to a group of patients with ABI. In addition, these participants will complete another series of classic tests on anosognosia and cognitive functions in order to find the convergent validity of the two tests proposed in this protocol. The external validity of the Cog-Awareness ADL Scale and the relationships between awareness components within the same ADL domain will be also analysed.

Ethics and dissemination

This study was approved by the Ethics Committee of Biomedical Research of Andalusia, on 13 January /2017 (Proceeding 1/2017). All participants are required to provide written informed consent. The findings from this will be disseminated via scientific publication.

Trial registration number

NCT03712839.
Predicting population health with machine learning: a scoping review
Authors: Morgenstern Jason Denzil , Buajitti Emmalin , O’Neill Meghan , Piggott Thomas , Goel Vivek , Fridman Daniel , Kornas Kathy , Rosella Laura C
Published: October 2020

Objective

To determine how machine learning has been applied to prediction applications in population health contexts. Specifically, to describe which outcomes have been studied, the data sources most widely used and whether reporting of machine learning predictive models aligns with established reporting guidelines.

Design

A scoping review.

Data sources

MEDLINE, EMBASE, CINAHL, ProQuest, Scopus, Web of Science, Cochrane Library, INSPEC and ACM Digital Library were searched on 18 July 2018.

Eligibility criteria

We included English articles published between 1980 and 2018 that used machine learning to predict population-health-related outcomes. We excluded studies that only used logistic regression or were restricted to a clinical context.

Data extraction and synthesis

We summarised findings extracted from published reports, which included general study characteristics, aspects of model development, reporting of results and model discussion items.

Results

Of 22 618 articles found by our search, 231 were included in the review. The USA (n=71, 30.74%) and China (n=40, 17.32%) produced the most studies. Cardiovascular disease (n=22, 9.52%) was the most studied outcome. The median number of observations was 5414 (IQR=16 543.5) and the median number of features was 17 (IQR=31). Health records (n=126, 54.5%) and investigator-generated data (n=86, 37.2%) were the most common data sources. Many studies did not incorporate recommended guidelines on machine learning and predictive modelling. Predictive discrimination was commonly assessed using area under the receiver operator curve (n=98, 42.42%) and calibration was rarely assessed (n=22, 9.52%).

Conclusions

Machine learning applications in population health have concentrated on regions and diseases well represented in traditional data sources, infrequently using big data. Important aspects of model development were under-reported. Greater use of big data and reporting guidelines for predictive modelling could improve machine learning applications in population health.

Registration number

Registered on the Open Science Framework on 17 July 2018 (available at https://osf.io/rnqe6/).
Uncovering motivation and self-regulated learning skills in integrated medical MOOC learning: a mixed methods research protocol
Authors: Hendriks Renée A , de Jong Peter G M , Admiraal Wilfried F , Reinders Marlies E J
Published: October 2020

Introduction

Massive Open Online Courses (MOOCs) are informal learning environments. Since a few years, MOOCs are being reused and integrated in formal medical education. However, what constitutes optimal integration is still unclear. In this mixed methods study protocol we describe how we will investigate three MOOC integration designs using the same MOOC.

This study holds multiple objectives

(1) Describe motivation profiles in medical students that learn in integrated MOOCs, and discern if motivation profiles are associated with specific MOOC integration designs; (2) investigate how psychological needs of medical students are satisfied or frustrated in different MOOC integration designs; (3) investigate the relationship between autonomous motivation to learn in an integrated MOOC and use of self-regulated
learning skills in that MOOC; (4) uncover processes that are involved in goal acceptance or rejection of medical students in integrated medical MOOC designs with assigned learning goals; and (5) identify obstacles medical students encounter when learning with assigned learning goals in integrated medical MOOCs.

Methods and analysis

Objectives 1 and 2 will be pursued with a cross-sectional study design, objective 3 with an observational cohort study design and objectives 4 and 5 with a qualitative interview study design. All medical students in one of three MOOC integration designs at Leiden University Medical Center (LUMC) will be invited to participate. Primary endpoints for objectives 1 and 2 are motivation profiles, and variety in need satisfaction and frustration. For objective 3 the primary endpoints are autonomous motivation and self-regulated online learning. For objectives 4 and 5 primary endpoints are process themes regarding goal acceptance or rejection, and perceived obstacles when working with assigned online learning goals.

Ethics and dissemination

This study has been approved by the Educational Research Review Board of the LUMC. Planned dissemination of findings include three presentations at (inter)national conferences and three research articles.
The Brabant study: design of a large prospective perinatal cohort study among pregnant women investigating obstetric outcome from a biopsychosocial perspective
Authors: Meems Margreet , Hulsbosch Lianne , Riem Madelon , Meyers Christina , Pronk Tila , Broeren Maarten , Nabbe Karin , Oei Guid , Bogaerts Stefan , Pop Victor
Published: October 2020

Background

Pregnancy is characterised by many biological and psychosocial changes. Adequate maternal thyroid function is important for the developing fetus throughout gestation. Latent class analyses recently showed three different patterns of change in thyroid function throughout pregnancy with different associations with obstetric outcome. Maternal distress during the pregnancy (anxiety and depression) negatively affects obstetric outcome. Pregnancy distress in turn may be affected by personality traits and attachment styles. Moreover, during the pregnancy, substantial social changes occur in the partner relationship and work experience. The aim of the Brabant study is to investigate the association between thyroid function trajectories and obstetric outcomes. Moreover, within the Brabant study, we will investigate how different trajectories of pregnancy distress are related to obstetric outcome, and the role of personality in this association. We will evaluate the possible role of maternal distress and attachment style on maternal–fetal bonding. Finally, we will study social changes in the perinatal period regarding partner relationship and well-being and performance at work.

Methods and analysis

The Brabant study is a longitudinal, prospective cohort study of an anticipated 4000 pregnant women. Women will be recruited at 8–10 weeks gestation among community midwife practices in South-East Brabant in the Netherlands. Thyroid function parameters (TSH and fT4), thyroid peroxidase antibody and human chorionic gonadotrophin will be assessed at 12, 20 and 28 weeks gestation. Moreover, at these three time points women will fill out questionnaires assessing demographic and obstetric features, life style habits and psychological and social variables, such as depressive symptoms, personality, partner relationship quality and burnout. Data from the obstetric records will also be collected.

Ethics and dissemination

The study has been approved by the Medical Ethical Committee of the Máxima Medical Center Veldhoven. Results will be submitted to peer-reviewed journals in the relevant fields and presented on national and international conferences.
Impact of involving people with dementia and their care partners in research: a qualitative study
Authors: Miah Jahanara , Parsons Suzanne , Lovell Karina , Starling Bella , Leroi Iracema , Dawes Piers
Published: October 2020

Objectives

We aimed to evaluate the impact of patient and public involvement (PPI) at each stage of the research cycle in a dementia research programme.

Design

We used monitoring forms to record the impact of the research programme’s PPI at different stages of research and qualitative interviews with all participants to evaluate the impact of PPI.

Setting

We evaluated Research User Groups (RUGs—older people with dementia and care partners) which were established to provide PPI support for the research programme in multiple European sites.

Participants

We purposively sampled RUG members (n=34) and researchers (n=13) who had participated in PPI activities. Inclusion criteria for the study were: (a) RUG members who had participated in the research awareness training and in PPI activities and had the capacity to consent; (b) researchers who involved RUGs in their work.

Results

Impact on the research: changes to the study conduct were made as a result of the feedback from RUGs. These included prioritisation of clinical recommendations, the wording of study information and recruitment materials, the content and layout of the user interface for a computerised memory test, interpretation of intervention results and advice on dissemination avenues. Impact on RUG members: they reported that involvement had given them a sense of purpose and satisfaction. Their perception of health research changed from being an exclusive activity to one, which lay people, could have meaningful involvement. Impact on researchers: PPI was a new way of working and interacting with PPI members had given them insight into the impact of their work on people living with dementia.

Conclusions

PPI can have a substantial impact on dementia research and the people involved in the research. To justify the time and expense of PPI, the advantageous practical impacts of PPI should be systematically recorded and consistently reported.
How do patients and general practitioners in Denmark perceive the communicative advantages and disadvantages of access via email consultations? A media-theoretical qualitative study
Authors: Grønning Anette , Assing Hvidt Elisabeth , Nisbeth Brøgger Matilde , Fage-Butler Antoinette
Published: October 2020

Objective

Email consultations have become part of everyday doctor–patient communication in many countries. The objective of this study is to investigate how patients and general practitioners (GPs) perceive the communicative advantages and disadvantages of access via email consultation drawing on a media-theoretical perspective.

Design

We analysed qualitative interview data from general practices in Denmark to identify salient themes.

Participants

Our data set consists of semi-structured interviews with 30 patients and 23 GPs. The data were collected from February 2016 to September 2019.

Results

The following themes emerged: (1) lower contact threshold, (2) accessing a new interaction space and (3) access to access. From the patients’ perspective, email consultations provided more convenient contact with their GP. From the GPs’ perspective, email consultations facilitated contact with patients whom they otherwise rarely saw, but also resulted in overuse and inappropriate use. Patients and GPs considered email consultations as inviting new interactions, facilitating also communication about emotional and sensitive issues. Both patients and GPs experienced email consultations as a way in which patients could achieve easier access to face-to-face consultations (access to access).

Conclusion

Drawing on a media perspective, this study adds knowledge of how the potentials of the medium of email consultations are perceived by GPs and patients. Email consultations do not simply extend existing forms of contact and consultation (face-to-face and telephone); they produce a new communication space with its own possibilities which result in new practices. With increasing use of email consultations, there may be challenges involved in transferring GP–patient communication to the written medium.
Effect of female sex work-targeted community-based interventions along the HIV treatment cascade in sub-Saharan Africa: a systematic review protocol
Authors: Atuhaire Lydia , Adetokunboh Olatunji , Shumba Constance , Nyasulu Peter S
Published: October 2020

Introduction

Female sex workers (FSWs) are a known high-risk group that are at increased risk of HIV transmission due to exposure to multiple sexual partners and inability to negotiate safe sex attributed to challenging economic circumstances. Previous systematic reviews have examined the effectiveness of HIV interventions prioritising FSWs and have shown that targeted interventions improve access to HIV prevention and treatment services. Interventions that increase FSWs’ uptake of services are well documented; however, evidence on specific interventions aimed at improving FSWs’ continuity in HIV care along the treatment cascade is lacking. This systematic review aims to document the performance of community-based interventions along the HIV treatment cascade.

Methods and analysis

We will use a sensitive search strategy for electronic bibliographic databases, bibliographies of included articles and grey literature sources. In addition, the Joint United Nations Programme on HIV/AIDS and the WHO websites, peer-reviewed conference papers and grey literature sources will be searched for additional reports of sex work programmes. We will include randomised controlled trials, cross-sectional surveys and cohort interventions where community-based HIV services were provided to FSWs and measure the performance of the HIV intervention on one or more cascade stages. We will conduct a systematic review of studies published from 2004 to present within the sub-Saharan Africa region. We will report quantitative study outcomes of HIV testing and diagnosis, linkage to care, initiation on antiretroviral therapy and viral suppression. We will analyse the data using the random-effects meta-analysis method, and funnel plots will be used to assess the publication bias.

Ethics and dissemination

This systematic review will not require ethical approval; we will publish data from manuscripts. The results of this study will be disseminated in peer-reviewed journals and conference presentations.

PROSPERO registration number

CRD42020157623.
Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial
Authors: Affret Aurélie , Luc Amandine , Baumann Cédric , Bergman Pierre , Le Faou Anne-Laurence , Pasquereau Anne , Arwidson Pierre , Alla François , Cambon Linda
Published: October 2020

Objective

To compare the effectiveness of the mobile e-Tabac Info Service (e-TIS) application (app) for helping adult smokers quit smoking with current practices.

Design

Pragmatic randomised controlled trial with a 1-year follow-up (2017–2018).

Setting

France, population-wide level.

Participants

2806 adult smokers who wished to quit smoking were recruited via the website of the French National Mandatory Health Insurance fund. Of them, 1400 were randomised to the e-TIS app arm and 1406 were randomised to the current practices arm (control).

Intervention

The app involved personalised interactive contacts that included questionnaires, advice, activities and text messages. All contacts were individually tailored and based on each smoker’s progress.

In the control group, recommended practices for quitting smoking were described on a non-interactive website.

Primary and secondary outcomes measures

The primary outcome was 7-day point prevalence abstinence (PPA) at 6 months. The secondary outcomes included continuous abstinence rates at 6 and 12 months, minimum 24-hour point abstinence at 3 months, minimum 30-day point abstinence at 12 months and number and duration of quit attempts.

Results

There was no difference between the e-TIS and control arms for the primary outcome (12.6% vs 13.7% for 7-day PPA at 6 months, p=0.3949, intention-to-treat analysis). However, e-TIS participants with high levels of exposure to the app, which was defined by the completion of at least eight activities or questionnaires, showed higher rates of smoking cessation than the control participants (17.6% vs 12.9% for 7-day PPA at 6 months, p=0.0169, per-protocol analysis).

Conclusion

Use of the e-TIS app was not associated with a higher rate of smoking cessation. However, high level of exposure to the e-TIS app may have been more effective than current practices.

Trial registration number

NCT02841683.
Determinants of treatment non-attendance among those referred to primary mental health care services in Western Sydney, Australia: a retrospective cohort study
Authors: Munasinghe Sithum , Page Andrew , Mannan Haider , Ferdousi Shahana , Peek Brendan
Published: October 2020

Objectives

Recommendations of the recent mental health reforms provided an opportunity to implement regional approaches to service provision through Primary Health Networks. This study is designed to identify the determinants of sociodemographic, diagnostic and referral-level factors and first treatment session non-attendance among those referred to primary mental health care (PMHC) services in Western Sydney, Australia.

Design

This study used routinely collected retrospective PMHC data between July 2016 and December 2018.

Setting

The study was based on a geographical catchment that covers four local government areas of Blacktown, Parramatta, Cumberland and Hills Shire in Western Sydney, Australia.

Participants

All individuals 5 years of age or older referred to PMHC services.

Primary outcome measure

First treatment session non-attendance, following a referral to receive psychological treatments.

Results

There were 9158 referrals received for 8031 clients, with 1769 (19.32%) referrals resulting in non-attendance to the first treatment session. Those with younger age (ORs ranging from 1.63 to 1.92), substance use (OR=1.55, 95% CI 1.17 to 2.06), poor English proficiency (OR=1.64, 95% CI 1.23 to 2.20), lower socioeconomic status (OR=1.57, 95% CI 1.34 to 1.83), psychotropic medication use (OR=1.20, 95% CI 1.06 to 1.36), and a referral by a social worker (OR=2.04, 95% CI 1.36 to 3.05), allied health (OR=1.49, 95% CI 1.03 to 2.16) or other professional (OR=1.72, 95% CI 1.30 to 2.29) were associated with a higher likelihood of first treatment session non-attendance. Those with a risk of suicide, who mainly speak a language other than English, and a previous use of PMHC services were more likely to attend their first treatment session.

Conclusion

Youth-specific treatment approaches, behavioural engagement strategies, facilitation of transport services for those live in deprived regions and improvements in capacity for mental health training among allied health professionals are areas of focus for primary care service and policy responses.
COVID-19 and ‘immune boosting’ on the internet: a content analysis of Google search results
Authors: Rachul Christen , Marcon Alessandro R , Collins Benjamin , Caulfield Timothy
Published: October 2020

Objective

The spread of misinformation has accompanied the coronavirus pandemic, including topics such as immune boosting to prevent COVID-19. This study explores how immune boosting is portrayed on the internet during the COVID-19 pandemic.

Design

Content analysis.

Methods

We compiled a dataset of 227 webpages from Google searches in Canada and the USA using the phrase ‘boost immunity’ AND ‘coronavirus’ on 1 April 2020. We coded webpages for typology and portrayal of immune boosting and supplements. We recorded mentions of microbiome, whether the webpage was selling or advertising an immune boosting product or service, and suggested strategies for boosting immunity.

Results

No significant differences were found between webpages that appeared in the searches in Canada and the USA. The most common types of webpages were from news (40.5%) and commercial (24.7%) websites. The concept of immune boosting was portrayed as beneficial for avoiding COVID-19 in 85.5% of webpages and supplements were portrayed as beneficial in 40% of the webpages, but commercial sites were more likely to have these portrayals. The top immune boosting strategies were vitamin C (34.8%), diet (34.4%), sleep (34.4%), exercise (30.8%) and zinc (26.9%). Less than 10% of the webpages provide any critique of the concept of immune boosting.

Conclusions

Pairing evidence-based advice for maintaining one’s health (eg, healthy diet, exercise, sleep) with the phrase immune boosting and strategies lacking in evidence may inadvertently help to legitimise the concept, making it a powerful marketing tool. Results demonstrate how the spread of misinformation is complex and often more subtle than blatant fraudulent claims.
What are the volume and budget needs to provide chemotherapy to all children with acute lymphoblastic leukaemia in Thailand? Development and application of an estimation tool
Authors: Sruamsiri Rosarin , Ferrario Alessandra , Ross-Degnan Dennis , Denburg Avram E , Frazier A Lindsay , Gupta Sumit , Ward Zachary J , Yeh Jennifer M , Wagner Anita Katharina
Published: October 2020

Objective

Insufficient access to anticancer medicines may contribute to the wide survival differences of children with cancers across the globe. We developed a tool to estimate the volume of medicines and budget requirements to provide chemotherapy to children with acute lymphoblastic leukaemia (ALL).

Design

Development and application of an estimation tool.

Setting

Paediatric oncology hospital departments in Thailand.

Participants

318 children aged 0–14 years diagnosed with ALL and 215 children with undiagnosed ALL.

Interventions

Estimates of volume and budget requirements for administering a full course of chemotherapy for ALL and a further course for children who relapse, according to National Treatment Guidelines.

Primary and secondary outcome measures

Primary outcome measures were the volume (mg) and cost (US$) of medicines needed to treat children with ALL. For medicines whose main indication is paediatric ALL (asparaginase and 6-mercaptopurine), we estimated the difference between volume needed and actual sales in 2017 (secondary outcome).

Results

Ten anticancer medicines and four chemoprotective agents are needed for the treatment of paediatric ALL according to the Thai treatment guidelines. Of these 14 medicines, 13 are included in the WHO essential medicines list for children. All are available as generics. We estimated that essential chemotherapy and chemoprotective agents to treat all children diagnosed with ALL in Thailand in 2017 would cost US$ 814 952 (US$ 1 365 422 for diagnosed and undiagnosed children), which corresponds to 0.005% (0.008%) of the country’s total health expenditure. The volumes of asparaginase and 6-mercaptopurine available on the Thai market in 2017 were more than sufficient (2.3 and 1.5 times the amounts needed, respectively) to treat all children diagnosed with ALL.

Conclusions

Procuring sufficient quantities of essential medicines to treat children with ALL requires relatively modest resources. Medicine cost should not be a major barrier to ALL treatment in similar settings.
Cystic fibrosis and the gut
Authors: Slae Mordechai , Wilschanski Michael
Published: October 2020

Cystic fibrosis (CF) is a recessive disease caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. The gene product, CFTR protein, has important manifestations in the intestine, pancreas and hepatobiliary system. Increased survival has caused CF to be primarily an adult disease today. Physicians must be knowledgeable as to the varied phenotype in the gastrointestinal tract. This review will outline the main gastrointestinal manifestations including a section on gastrointestinal malignancy in CF. Novel treatments treating the basic effect in CF are now being introduced and their effects on the gastrointestinal tract are discussed.
Telephone clinic improves gluten-free dietary adherence in adults with coeliac disease: sustained at 6 months
Authors: Muhammad Humayun , Reeves Sue , Ishaq Sauid , Mayberry John Francis , Jeanes Yvonne Margaret
Published: October 2020

Background

A gluten-free (GF) diet is the only treatment for coeliac disease (CD), non-adherence to the diet is associated with greater morbidity. The study aimed to examine the effect of a telephone clinic, designed to increase GF dietary knowledge and adherence, in adults with CD.

Methods

A prospective study of 125 patients with histologically confirmed CD. Patients, not adhering to a GF diet (n=30), engaged in a personalised telephone clinic. Validated questionnaires were used to assess GF dietary adherence (Coeliac Disease Adherence Test; CDAT), knowledge of GF foods and CD-related quality of life (QoL). GF dietary adherence was assessed up to 12 months post telephone clinic. The control group completed the questionnaires only.

Results

GF dietary adherence (CDAT) median scores significantly improved at 3 and 6 months after the telephone clinic compared with baseline (16, 13 and 13, respectively, p<0.01). Reassuringly, the dietary burden QoL score remained similar to baseline values. No change in CDAT scores were observed in the control group. Change in GF dietary knowledge score was associated with improved GF dietary adherence CDAT score (r=−0.22; p=0.039). At 9 and 12 months, CDAT scores were similar to baseline values.

Conclusions

Telephone clinics have a positive impact on dietary knowledge and GF dietary adherence in adults with CD, promoting health-benefitting behaviours in those previously not adhering to a GF diet. The study highlights the need for patients to have regular follow-up, with targeted reviews for those not adhering to a GF diet.
Hypertension attenuates the prognostic value of coronary artery calcification scoring in low-risk patients
Authors: Maclean Edd , Sehmi Joban , Kanaganayagam Gajen , Nicol Edward David
Published: October 2020

Objectives

In outpatients with suspected ischaemic symptoms, we investigated the impact of risk factor profile on the prognostic value of coronary artery calcium scoring (CACS) and CT coronary angiography (CTCA).

Methods

772 consecutive patients underwent CACS and CTCA; 52 patients (6.7%) with significant coronary artery lesions underwent revascularisation within 60 days and were excluded. 720 remaining patients were followed up for 38.1±17.4 months.

Results

Late presentation (after 60 days) major adverse cardiovascular events (MACEs) were recorded in 27 patients (3.8%). Hypertension was strongly associated with adverse outcomes (unadjusted HR 6.5 (2.9 to 14), p<0.001), and hypertensive patients had double the prevalence of non-calcified plaque versus normotensive individuals (30.2% vs 14.3%, p<0.001). Adjusting for confounders, severe stenosis at CTCA was predictive of MACE for normotensive and hypertensive patients (HR 9.6 (2.8 to 43.1), p<0.001, and HR 6.2 (2.4 to 16.1), p<0.001, respectively). CACS alone was not predictive of MACE throughout the cohort (HR 1.001 (0.9997 to 1.001), p=0.36) and when adjusting for confounders, a cut-off of CACS>400 predicted MACE in normotensive individuals (HR 10.6 (2.41 to 49.3), p<0.001) but not in hypertensive individuals (HR 1.3 (0.5 to 3.6), p=0.56). Zero calcium score did not mitigate the risk of MACE (HR 0.84 (0.39 to 1.8), p=0.65) and 13/27 patients (48.1%) who suffered MACE had a 0 calcium score; all had hypertension.

Conclusions

In low-risk patients with stable cardiovascular symptoms, CTCA provides important additive prognostic information over CACS, and CACS (including CACS>400) underestimated cardiovascular risk in patients with hypertension. This may relate to the increased prevalence of non-calcified plaque in these individuals.
Contemporary differences between bicuspid and tricuspid aortic valve in chronic aortic regurgitation
Authors: Yang Li-Tan , Benfari Giovanni , Eleid Mackram , Scott Christopher G , Nkomo Vuyisile T , Pellikka Patricia A , Anavekar Nandan S , Enriquez-Sarano Maurice , Michelena Hector I
Published: October 2020

Objective

To comprehensively explore contemporary differences between bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV) patients with chronic haemodynamically significant aortic regurgitation (AR).

Methods

Consecutive patients with chronic ≥moderate-severe AR from a tertiary referral centre (2006–2017) were included. All-cause mortality, surgical indications and aortic valve surgery (AVS) were analysed.

Results

Of 798 patients (296 BAV-AR, age 46±14 years; 502 TAV-AR, age 67±14 years, p<0.0001) followed for 5.5 (IQR: 2.9–9.2) years, 403 underwent AVS (repair in 96) and 154 died during follow-up. The 8-year AVS incidence was 60%±3% versus 53%±3% for BAV-AR and TAV-AR, respectively (p=0.014). The unadjusted (real-life) 8-year total survival was 93%±7% versus 71%±2% for BAV-AR and TAV-AR, respectively (p<0.0001), and became statistically insignificant after sole adjustment for age (p=0.14). The within-group relative risk of death in BAV-AR patients demonstrated a large age-dependent increase (two fold at 50–55 years, up to 10-fold at 70 years). The presence of baseline symptoms was significantly associated with death for both BAV-AR (p=0.039) and TAV-AR (p<0.0001), but the strength of the association decreased with age adjustment for BAV-AR (age-adjusted HR 2.43 (0.92–6.39), p=0.07) and not for TAV-AR (age-adjusted HR, 2.3 (1.6–3.3), p<0.0001). As compared with general population, TAV-AR exhibited baseline excess risk which further increased at left ventricular ejection fraction (LVEF) <60% and left ventricular end-systolic dimension index (LVESDi) >20 mm/m2; similar thresholds were observed for BAV-AR patients.

Conclusion

BAV-AR patients were two decades younger than TAV-AR and underwent AVS more frequently, resulting in a considerable real-life survival advantage for BAV-AR that was determined primarily by age and not valve anatomy. Pragmatically, regardless of valve anatomy, patients with haemodynamically significant AR and age >50–55 years require a low-threshold for surgical referral to prevent symptom development where LVEF <60% and LVESDi >20 mm/m2 seem appropriate referral thresholds.
The epidemiology of gynaecologic health: contemporary opportunities and challenges
Authors: Hoffman Sarah R , Farland Leslie V , Doll Kemi M , Nicholson Wanda K , Wright Maya A , Robinson Whitney R
Published: October 2020

The field of reproductive epidemiology has primarily focused on reproductive outcomes and gynaecologic cancers. The study of non-cancerous, gynaecologic conditions (eg, uterine fibroids, endometriosis) has not received serious treatment in existing epidemiology textbooks and reproductive epidemiology curricula. Further, these conditions do not neatly fit into the other common subdisciplines within epidemiology (eg, infectious disease, cardiovascular, injury and occupational epidemiology and so on). In this commentary, we identify and illustrate three critical challenges to advancing the epidemiologic research of non-cancerous, gynaecologic conditions. With greater investment and a patient-centred approach, epidemiology can advance knowledge about this critical area of human welfare.