bluuebunny/crossref_metadata_2025 huggingface dataset:
Association between psychosocial distress, sexual disorders, self-esteem and quality of life with male androgenetic alopecia: a population-based study with men at age 46
Authors: Sinikumpu Suvi-Päivikki , Jokelainen Jari , Auvinen Juha , Timonen Markku , Huilaja Laura
Published: December 2021

Objectives

To study the association between androgenetic alopecia (AGA) and its severity with psychosocial well-being in male subjects aged 46 years at the population level.

Design

Cross-sectional study.

Setting

The Northern Finland Birth Cohort 1966 (NFBC1966).

Participants

Data were available for 892 male subjects aged 46 years.

Interventions

Study subjects underwent comprehensive health examinations including a skin evaluation by dermatologists and determination of AGA according to the Norwood classification. They also filled in a questionnaire battery that included previously validated questionnaires: the Hopkins Symptom Checklist-25, the Beck Depression Inventory–II; the Generalised Anxiety Disorder Screener; a 15-dimensional measure of health-related quality of life; a 12-Item General Health Questionnaire. The battery also included questions about self-esteem and sexual health.

Main outcome measurements

The presence of AGA and its severity, psychosocial well-being.

Results

AGA was found in 68.5% of subjects, 27.8% of the cases were severe, 33.2% moderate and 39.0% mild. There was no significant association between the presence of AGA or its severity with depression, anxiety, quality of life, self-esteem or sexual symptoms. Those with severe AGA reported lower sexual activity when compared with those without AGA; however, the difference was not statistically significant.

Conclusions

Middle-aged men with AGA did not differ from men without AGA in terms of psychosocial well-being.
Rationale, design and protocol of a cross-sectional study on pregnancy-related cardiovascular diseases in Tanzania (PRECARDT): burden, characterisation and prognostic significance at delivery
Authors: Makubi Abel , Chillo Pilly , Mutagaywa Reuben , Balandya Belinda , Kisenge Peter , Tarimo Vincent , Mujuni Eva , Msaki Evarist B , Mgaya Josephine , Kihunrwa Albert , Janabi Mohamed , Kwesigabo Gideon , Makani Julie , Kendall Lindsay , Addo Juliet , Mmbando Bruno , Sliwa Karen
Published: December 2021

Introduction

The paucity of data describing cardiovascular disease (CVD) in pregnancy in many parts of Africa including Tanzania has given rise to challenges in proper management by the healthcare providers. This study is set out to (1) determine the prevalence of a range of CVDs during pregnancy in women attending antenatal clinics in Tanzania and (2) determine the impact of these CVDs on maternal and fetal outcomes at delivery.

Methods and analysis

This is a cross-sectional study with a prospective component to be conducted in two referral hospitals in Tanzania. Pregnant women aged ≥18 years diagnosed with a CVD during the antenatal period are being identified and extensively characterised by performing clinical assessment, modified WHO staging, electrocardiography, echocardiography and laboratory tests. Patients identified with CVDs (exposed) and a subset without (unexposed) will be followed up to determine maternal and fetal outcomes at delivery. A minimum sample of 1560 will be sufficient to estimate the prevalence of CVDs with a 95% CI of 2.75% to 5.25%.

Ethics and dissemination

The study is being conducted in accordance with the Helsinki declaration on studies involving human subjects. Ethical approvals have been obtained from Muhimbili University (reference number DA.282/298/01.C/) and Bugando Medical Centre (reference number CREC/330/2019) Ethics Committees. Informed consent is sought from all potential participants before any interview or investigations are performed. Study findings will be disseminated to the scientific community through different methods. Results will also be communicated to policymakers and to the public, as appropriate.
Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: a systematic review and meta-analysis of randomised controlled trials
Authors: Wu Wenjuan , Qiu Lingxiao , Wu Jizhen , Liu Xueya , Zhang Guojun
Published: December 2021

Objectives

Idiopathic pulmonary fibrosis (IPF) has been defined as a distinctive type of chronic fibrotic disease, characterised by a progressive decline in lung function and a common histological pattern of interstitial pneumonia. To analyse the efficacy and safety of pirfenidone in the treatment of IPF, a systematic review and meta-analysis was performed.

Design

This is a meta-analysis study.

Participants

Patients were diagnosed as IPF.

Interventions

Use of pirfenidone.

Primary and secondary outcome

Progression-free survival (PFS), acute exacerbation and worsening of IPF and Impact on adverse events.

Measures

The inverse variance method for the random-effects model was used to summarise the dichotomous outcomes, risk ratios and 95% CIs.

Results

A total of 9 randomised controlled trials with 1011 participants receiving pirfenidone and 912 controls receiving placebo were summarised. The pooled result suggested a statistically significant difference inall-cause mortality after pirfenidone use, with a summarised relative ratio of 0.51 (p<0.01). Longer PFS was observed in patients receiving pirfenidone compared with those who were given placebo (p<0.01). The IPF groups presented a high incidence of adverse events with a pooled relative ratio of 3.89 (p<0.01).

Conclusions

Pirfenidone can provide survival benefit for patients with IPF. Pirfenidone treatment was also associated with a longer PFS, a lower incidence of acute exacerbation and worsening of IPF.
nSeP: immune and metabolic biomarkers for early detection of neonatal sepsis—protocol for a prospective multicohort study
Authors: Chakraborty Mallinath , Rodrigues Patrícia R S , Watkins W John , Hayward Angela , Sharma Alok , Hayward Rachel , Smit Elisa , Jones Rebekka , Goel Nitin , Asokkumar Amar , Calvert Jennifer , Odd David , Morris Ian , Doherty Cora , Elliott Sian , Strang Angela , Andrews Robert , Zaher Summia , Sharma Simran , Bell Sarah , Oruganti Siva , Smith Claire , Orme Judith , Edkins Sarah , Craigon Marie , White Daniel , Dantoft Widad , Davies Luke C , Moet Linda , McLaren James E , Clarkstone Samantha , Watson Gareth L , Hood Kerenza , Kotecha Sailesh , Morgan B. Paul , O’Donnell Valerie B , Ghazal Peter
Published: December 2021

Introduction

Diagnosing neonatal sepsis is heavily dependent on clinical phenotyping as culture-positive body fluid has poor sensitivity, and existing blood biomarkers have poor specificity.

A combination of machine learning, statistical and deep pathway biology analyses led to the identification of a tripartite panel of biologically connected immune and metabolic markers that showed greater than 99% accuracy for detecting bacterial infection with 100% sensitivity. The cohort study described here is designed as a large-scale clinical validation of this previous work.

Methods and analysis

This multicentre observational study will prospectively recruit a total of 1445 newborn infants (all gestations)—1084 with suspected early—or late-onset sepsis, and 361 controls—over 4 years. A small volume of whole blood will be collected from infants with suspected sepsis at the time of presentation. This sample will be used for integrated transcriptomic, lipidomic and targeted proteomics profiling. In addition, a subset of samples will be subjected to cellular phenotype and proteomic analyses. A second sample from the same patient will be collected at 24 hours, with an opportunistic sampling for stool culture. For control infants, only one set of blood and stool sample will be collected to coincide with clinical blood sampling. Along with detailed clinical information, blood and stool samples will be analysed and the information will be used to identify and validate the efficacy of immune-metabolic networks in the diagnosis of bacterial neonatal sepsis and to identify new host biomarkers for viral sepsis.

Ethics and dissemination

The study has received research ethics committee approval from the Wales Research Ethics Committee 2 (reference 19/WA/0008) and operational approval from Health and Care Research Wales. Submission of study results for publication will involve making available all anonymised primary and processed data on public repository sites.

Trial registration number

NCT03777670
Patient, carer and healthcare professional experiences of complex care quality in multidisciplinary primary healthcare centres: qualitative study with face-to-face, in-depth interviews and focus groups in five French multidisciplinary primary healthcare centres
Authors: Derriennic Jérémy , Barais Marie , Le Goff Delphine , Fernandez Guillaume , Le Borne Françoise , Le Reste Jean-Yves
Published: December 2021

Objectives

To explore care experiences in multidisciplinary primary healthcare centres from the patients, carers and healthcare professionals perspectives.

Design

This qualitative study used face-to-face, in-depth interviews and focus groups. Patients with multimorbidity monitored by a General Practitioner (GP) and another professional from the health centre were recruited through purposive sampling and included with their carer. They were interviewed together while professionals were interviewed separately. Verbatims were coded with subsequent blind analysis, using an inductive approach, to find aspects and features. The constant comparative method highlighted data consistencies and variations.

Participants

Twenty-six patients, 23 family carers and 57 healthcare professionals.

Setting

Five multidisciplinary primary healthcare centres, in France, between March 2017 and December 2018.

Results

This unique study grouped perspectives into nine core quality of primary care aspects: having accessible, available, and varied care; feeling welcome and enjoying comfortable, well-equipped, and clean premises; having quality medicotechnical care (medical knowledge and technical skills); having a reliable GP; receiving appropriate care from healthcare professionals other than the GP; maintaining an efficient relationship with healthcare professionals; benefiting from organised and coordinated care; being an informed, supported and involved patient; having an informed, supported and involved carer. New areas of interest include the multidisciplinary nature of the centres, appreciation of other professionals within the centre, medicotechnical dimensions of care and the carer’s role in maintaining patient autonomy.

Conclusions

This is the first study to interview patients and carers alongside healthcare professionals. This enhanced knowledge improves understanding of these aspects and can guide implementation of evaluation tools that truly reflect patient and carer needs and enable an efficient experience in terms of quality. To address deficiencies in existing questionnaires, the new perspectives found will be added to former aspects to create a comprehensive quality of primary care evaluation tool.

Trial registration number

NCT02934711, Results.
Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol
Authors: Rangaka Molebogeng X , Hamada Yohhei , Duong Trinh , Bern Henry , Calvert Joanna , Francis Marie , Clarke Amy Louise , Ghanouni Alex , Hack Vanessa , Owen-Powell Ellen , Surey Julian , Sanders Karen , Booth Helen L , Crook Angela , Griffiths Chris , Horne Robert , Kunst Heinke , Lipman Marc , Mandelbaum Mike , White Peter J , Whiting Penny , Zenner Dominik , Abubakar Ibrahim
Published: December 2021

Introduction

The predictive utility for incident tuberculosis (TB) of the purified protein derivative tuberculin skin test and region of difference 1 (RD1)-based interferon-gamma release assays (IGRA) is comparable; and either is recommended to test for latent TB infection (LTBI). Despite associated high costs of IGRA, sites participating in LTBI screening in many high-income settings pragmatically favour IGRA due to its higher specificity and simpler logistics. A new RD1-based skin test, C-Tb, could offer an acceptable and as accurate, cheaper alternative to IGRA. Evaluating the impact of C-Tb on process and patient-related outcomes would provide important information to help guide its use in LTBI testing strategies.

Methods and analysis

This is a pragmatic multicentre, open-label, non-inferiority, randomised controlled trial. The trial will assess the initiation of LTBI treatment following a positive result of the randomised test as the primary outcome. Participants will be randomised to receive the C-Tb test (intervention) or IGRA (usual care, control) for initiation of treatment. We will enrol 1530 participants in England aged≥16 years who are eligible for LTBI testing and treatment according to UK guidance. In the C-Tb arm, skin induration will be assessed 2–3 days after intradermal injection and measured in millimetres of induration. Results of IGRA will be obtained in line with standard practice. Behavioural studies will explore people’s experiences, perspectives and preferences of LTBI testing and treatment. Economic analysis will estimate cost-effectiveness of changes to the diagnostic algorithm for LTBI. The protocol was developed with Patient and Public Involvement (PPI), which will continue throughout the trial.

Ethics and dissemination

Ethics approval has been obtained from The NHS Health Research Authority (269485). We will share results of the trial in peer-reviewed journals and conferences.

Trial registration number

EudraCT 2019-002592-34;ISRCTN17936038.
Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial
Authors: Lehtinen Matti , Lagheden Camilla , Luostarinen Tapio , Eriksson Tiina , Apter Dan , Bly Anne , Gray Penelope , Harjula Katja , Heikkilä Kaisa , Hokkanen Mari , Karttunen Heidi , Kuortti Marjo , Nieminen Pekka , Nummela Mervi , Paavonen J , Palmroth Johanna , Petäjä Tiina , Pukkala Eero , Soderlund-Strand Anna , Veivo Ulla , Dillner Joakim
Published: December 2021

Background

Human papillomavirus (HPV) vaccination protects against HPV, a necessary risk factor for cervical cancer. We now report results from population-based follow-up of randomised cohorts that vaccination provides HPV-type-specific protection against invasive cancer.

Methods

Individually and/or cluster randomised cohorts of HPV-vaccinated and non-vaccinated women were enrolled in 2002–2005. HPV vaccine cohorts comprised originally 16–17 year-old HPV 16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2465) and HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866). Altogether, 3341 vaccines were followed by the Finnish Cancer Registry in the same way as 16 526 non-HPV-vaccinated controls. The control cohort stemmed from 15 665 originally 18–19 years-old women enrolled in 2003 (6499) or 2005 (9166) and 861 placebo recipients of the FUTURE II trial. The follow-up started 6 months after the clinical trials in 2007 and 2009 and ended in 2019. It was age aligned for the cohorts.

Findings

During a follow-up time of up to 11 years, we identified 17 HPV-positive invasive cancer cases (14 cervical cancers, 1 vaginal cancer, 1 vulvar cancer and 1 tongue cancer) in the non-HPV-vaccinated cohorts and no cases in the HPV-vaccinated cohorts. HPV typing of diagnostic tumour blocks found HPV16 in nine cervical cancer cases, HPV18, HPV33 and HPV52 each in two cases and HPV45 in one cervical cancer case. The vaginal, vulvar and tongue cancer cases were, respectively, positive for HPV16, HPV52/66 and HPV213. Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05).

Interpretation

Vaccination is effective against invasive HPV-positive cancer.

Trial registration number

NCT00122681, Post-results;NCT00169494, Post-results;NCT00092534, Post-results.
Serious game to promote socioemotional learning and mental health (emoTIC): a study protocol for randomised controlled trial
Authors: De la Barrera Usue , Postigo-Zegarra Silvia , Mónaco Estefanía , Gil-Gómez José-Antonio , Montoya-Castilla Inmaculada
Published: December 2021

Introduction

The development of emotional competences may be a protective factor for mental health problems, promoting well-being at such a complex age as adolescence. Technologies may be used to carry out this empowerment because adolescents are attracted to them. The purpose of the study is to design a serious game based on the Mayeret al’s emotional intelligence ability model and analyse the effectiveness of theemoTICprogramme to develop emotional competences, well-being, mental health, and personal strengths immediately after completion and at 12 months.

Methods and analysis

The new version ofemoTICwill be designed following the suggestions of the adolescents who participated in the pilot study and the results obtained from the statistical analysis. The participants will be 385 adolescents aged 11–16 years who will be randomly assigned to the control group and the experimental group. The experimental group will complete theemoTICprogramme. The primary outcomes include emotional competences and subjective well-being. The secondary outcomes are self-esteem; general self-efficacy; personality; social and personal responsibility; school social climate; somatic complaints; depression, anxiety and stress symptoms; emotional and behavioural difficulties; suicidal behaviour; and subjective happiness. Data will be collected at three moments: baseline (T1), immediately post-intervention (T2) and 12-month follow-up (T3). The effectiveness of the programme will be analysed using different statistical packages.

Ethics and dissemination

The study has been approved by the Ethics Commission of the University of Valencia (H152865096049), and the standards of the Declaration of Helsinki to collect the data will be followed. Results will be disseminated across the scientific community.

Trial registration number

ClinicalTrials.gov Registry (NCT04414449).

Trial sponsor

University of Valencia. Principal investigator: Inmaculada Montoya-Castilla.
More GP contacts and poorer health of informal caregivers with low socioeconomic status in Germany: results from the population-based DEGS1 and the cross-sectional GPCare-1 study
Authors: Gavrilov Boris , Schmidt Manuela , Kasten Stefanie , Sommer Samira , Hunzelar Carmen , Bockheim Florian , Paños-Willuhn Joana , Offenberg Luisa , Oberholz Maja , Ikar Nur , Weltermann Birgitta
Published: December 2021

Objectives

Informal caregivers are known to have poorer mental health. Risk factors for caregiver burden include low education, female gender, cohabitation with the care recipient and lack of resources. General practitioners (GPs) have an important role in supporting caregivers. Drawing on data from two surveys, associations between caregivers’ socioeconomic status (SES), psychophysical health and GP contacts are analysed.

Design

Cross-sectional study. The study draws on data from two surveys (German Health Interview and Examination Survey for Adults, DEGS1 and General Practice Care-1, GPCare-1).

Setting

Germany.

Participants

DEGS1: German general population (18+ years) n=7987. GPCare-1: general practice patients (18+ years) n=813.

Primary outcome

Psychophysical health, GP contacts and communication.

Methods

Using representative DEGS1 data, the prevalence of informal caregivers, caregivers’ burden, chronic stress, various health conditions and frequency of GP contacts were evaluated stratified by SES. Data from the GPCare-1 study addressed caregivers’ experiences and communication preferences with GPs.

Results

In the DEGS1, the prevalence of caregivers was 6.5%. Compared with non-caregivers, caregivers scored significantly higher for chronic stress (15.45 vs 11.90), self-reported poor health (37.6% vs 23.7%) and GP visits last year (3.95 vs 3.11), while lifestyle and chronic diseases were similar. Compared with caregivers with medium/high SES, those with low SES had a significantly lower prevalence of high/medium caregiver burden (47.9% vs 67.7%) but poorer self-reported health (56.9% vs 33.0%), while other characteristics did not differ. In the GPCare-1 study, the prevalence of caregivers was 12.6%. The majority of them felt that their GP takes their problems seriously (63.6%) without difference by SES.

Conclusion

Caregivers with low SES constitute an especially high-risk group for psychological strain, requiring special GP attention to support their needs.
Target and actual sample sizes for studies from two trial registries from 1999 to 2020: an observational study
Authors: Barnett Adrian Gerard , Glasziou Paul
Published: December 2021

Objectives

To investigate differences between target and actual sample sizes, and what study characteristics were associated with sample sizes.

Design

Observational study.

Setting

The large trial registries of clinicaltrials.gov (starting in 1999) and ANZCTR (starting in 2005) through to 2021.

Participants

Over 280 000 interventional studies excluding studies that were withheld, terminated for safety reasons or were expanded access.

Main outcome measures

The actual and target sample sizes, and the within-study ratio of the actual to target sample size.

Results

Most studies were small: the median actual sample sizes in the two databases were 60 and 52. There was a decrease over time in the target sample size of 9%–10% per 5 years, and a larger decrease of 18%–21% per 5 years for the actual sample size. The actual-to-target sample size ratio was 4.1% lower per 5 years, meaning more studies (on average) failed to hit their target sample size.

Conclusion

Registered studies are more often under-recruited than over-recruited and worryingly both target and actual sample sizes appear to have decreased over time, as has the within-study gap between the target and actual sample size. Declining sample sizes and ongoing concerns about underpowered studies mean more research is needed into barriers and facilitators for improving recruitment and accessing data.
Association between haemorrhoids and Graves’ disease: a retrospective cohort study using data from Taiwan’s Longitudinal Health Insurance Database
Authors: Zhong Shang-Rong , Chen Hsin-Hung , Liao Chun-Cheng , Su Chun-Hung , Yip Hei-Tung , Kao Chia-Hung
Published: December 2021

Objective

To evaluate the relationship between haemorrhoids and Graves’ disease (GD).

Setting

Using the nationwide data from Taiwan’s Longitudinal Health Insurance Database.

Participants

We conducted a retrospective study, stratified patients by International Classification of Diseases, Ninth Revision, Clinical Modification disease code and compared the incidence rate of GD between patients with and without haemorrhoids. The study period was from 2000 to 2010, with exclusion of patients with diagnosed haemorrhoids before 2000 or after 2009, and we analysed the HR of GD in the univariable and multivariable models as well as the cumulative incidence curves of GD by using Kaplan-Meier curves.

Result

This study included 13 165 and 52 660 patients with and without haemorrhoids, respectively. The mean follow-up duration was approximately 6 years. The incidence rate of GD was 1.57 and 1.13 per 1000 person-years in patients with and without haemorrhoids, respectively. The area under the cumulative incidence curve of GD in patients with haemorrhoids was higher than that of patients without haemorrhoids. The risk of GD increased by 1.39 times (95% CI 1.13 to 1.71) in patients with haemorrhoids compared with patients without haemorrhoids. In the subgroup analysis, women with haemorrhoids had a higher risk of GD (adjusted HR 1.44; 95% CI 1.13 to 1.83). Patients with haemorrhoids aged 30–39 years were more likely to develop GD (adjusted HR 1.73; 95% CI 1.18 to 2.55).

Conclusion

The findings of this study indicate that patients with haemorrhoids may have an increased risk of GD compared with other potential confounding factors.
Effects of artificial intelligence-SsupporTed Automated NutRiTional Intervention on LDL cholesterol Control in Patients with Familial Hypercholesterolaemia (iSTART-FH): protocol for a randomised controlled trial
Authors: Tada Hayato , Okada Hirofumi , Nomura Akihiro , Usui Soichiro , Sakata Kenji , Hayashi Kenshi , Fujino Noboru , Yasugi Ayaka , Takahara Shizuko , Imai Yasuhito , Takamura Masayuki , Kawashiri Masa-aki
Published: December 2021

Introduction

Familial hypercholesterolaemia (FH) is an autosomal dominant inherited genetic disease that has an extremely elevated cardiovascular risk because of their significantly elevated low-density lipoprotein (LDL) cholesterol. Nutritional intervention is needed in improving LDL cholesterol control in patients with FH but requires a considerable burden in manpower. Artificial intelligence (AI)-supported and mobile-supported nutritional intervention using this technique may be an alternative approach to traditional nutritional counselling in person. This study aims to test the hypothesis that AI-supported nutritional counselling is more effective in reducing LDL cholesterol than the in-person, face-to-face method in terms of improving LDL cholesterol control in patients with FH.

Methods and analysis

This is a single-centre, unblinded, cross-over, randomised controlled study comparing the efficacy of AI-supported automated nutrition therapy with that of conventional human nutrition counselling in patients with FH. Patients with FH are recruited and randomly assigned to AI-supported nutrition counselling (n=30) and to face-to face nutrition counselling (n=30). We are using an Asken, a mobile application that has been specially modified for this study so that it follows the recommendations by the Japan Atherosclerosis Society. We started patient recruitment on 1 September 2020, and is scheduled to continue until 31 December 2022.

Ethics and dissemination

This study is being conducted in compliance with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and all other applicable laws and guidelines in Japan. The study protocol was approved by the Institutional Review Board of Kanazawa University on 13 April 2020 (IRB no. 2623-3); all recruited patients are required to provide written informed consent. We will disseminate the final results at international conferences and in a peer-reviewed journal.

Trial registration number

UMIN000040198.
Opening closed doors: using machine learning to explore factors associated with marital sexual violence in a cross-sectional study from India
Authors: McDougal Lotus , Dehingia Nabamallika , Bhan Nandita , Singh Abhishek , McAuley Julian , Raj Anita
Published: December 2021

Objectives

Sexual violence against women is pervasive in India. Most of this violence is experienced in the context of marriage, and rates of marital sexual violence (MSV) have been relatively stagnant over the past decade. This paper machine learning algorithms paired with qualitative thematic analysis to identify new and potentially modifiable factors influencing MSV in India.

Design, setting and participants

This cross-sectional analysis of secondary data used data from in-person interviews with ever-married women aged 15–49 who responded to gender-based violence questions in the nationally representative 2015–2016 National Family Health Survey (N=66 013), collected between 20 January 2015 and 4 December 2016. Analyses included iterative thematic analysis (L-1 regularised regression followed by iterative qualitative thematic coding of L-2 regularised regression results) and neural network modelling.

Outcome measure

Participants reported their experiences of sexual violence perpetrated by their current (or most recent) husband in the previous 12 months. These responses were aggregated into any vs no recent MSV.

Results

Nearly 7% of women experienced MSV in the past 12 months. Major themes associated with MSV through iterative thematic analysis included experiences of/exposure to violence, sexual behaviour, decision making and freedom of movement, sociodemographics, access to media, health knowledge, health system interaction, partner control, economic agency, reproductive and maternal history, and health status. A neural network model identified variables that largely corresponded to these themes.

Conclusions

This analysis identified several themes that may be promising avenues to identify and support women experiencing MSV, and to mitigate these traumatic experiences. In particular, amplifying screening activities at health encounters, especially among women who appear to have compromised health or restricted agency, may enable a greater number of women access to essential physical and emotional support services, and merits further consideration.
Lived experiences of healthcare workers on the front line during the COVID-19 pandemic: a qualitative interview study
Authors: Grailey Kate , Lound Adam , Brett Stephen
Published: December 2021

Objectives

This study aimed to investigate the presence of perceived stressors, psychological safety and teamwork in healthcare professionals. As the timeframe for this study spanned the first wave of the COVID-19 pandemic, data were captured demonstrating the impact of the pandemic on these factors.

Design

Qualitative interview study.

Setting

All staff working within the emergency and critical care departments of one National Health Service Trust in London, UK.

Participants

Forty-nine participants were recruited using a purposive sampling technique and interviewed when the first wave of the COVID-19 pandemic had subsided.

Main outcome measures

Evaluation of changes in perceived stressors, psychological safety and teamwork in individuals working during the COVID-19 pandemic.

Results

The thematic analysis relating to a participant’s lived experiences while working during COVID-19 led to the construction of five key themes, including ‘psychological effects’ and ‘changes in team dynamics’. Several psychological effects were described, including the presence of psychological distress and insights into the aetiology of moral injury. There was marked heterogeneity in participants’ response to COVID-19, particularly with respect to changes in team dynamics and the perception of a psychologically safe environment. Descriptions of improved team cohesiveness and camaraderie contrasted with stories of new barriers, notably due to the high workload and the impact of personal protective equipment. Building on these themes, a map of key changes arising due to the pandemic was developed, highlighting potential opportunities to provide targeted support.

Conclusions

Working on the front line of a pandemic can have significant implications for healthcare workers, putting them at risk of psychological distress and moral injury, as well as affecting team dynamics. There is striking heterogeneity in the manifestation of these challenges. Team leaders can use the themes and qualitative data from this study to help identify areas for management focus and individual and team support.
Resilient healthcare theory as a lens to research emergency department operations: a protocol for a scoping review
Authors: Chessum Peter Thomas , Sujan Mark , Xyrichis Andreas , Anderson Janet E
Published: December 2021

Introduction

Emergency departments (EDs) are complex systems that have constant fluctuations in demand, creating mismatches with planned capacity. Despite the complexity of ED operations, quality and safety improvement are often approached in a reactive, linear and reductionist manner. There is increasing interest in adopting Resilient Healthcare (RHC) techniques based on complex systems thinking as a method for quality improvement and research in EDs. However, the evidence for this approach is still developing and it is not clear what techniques have been used so far and which are most effective. This scoping review will be conducted between March 2022 until May 2022. It seeks to examine the international literature for available reports that have adopted RHC theory to study ED operations and identify approaches used and proposed benefits.

Methods and analysis

The methodology for scoping reviews outlined by Arksey and O’Malley (2005) will be followed, acknowledging refinements made to the scoping review process by Levacet al(2010). The methodology consists of five steps: (1) identifying the research question; (2) identifying the relevant literature; (3) study selection; (4) charting the data; and (5) collating, summarising and reporting the results. A two-stage approach will be undertaken to synthesise and report results: (1) numerical analysis of the nature and distribution of studies (the overall number of studies, country of origin, the most studied core function of ED, type of research design); and (2) a thematic mapping of the literature.

Ethics and dissemination

Scoping review methodology synthesises published data and, therefore, does not require ethical approval. An article formatted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses forScoping Reviews reporting guidance will be submitted for publication to a scientific journal. Findings will also be presented at relevant advanced practice conferences and disseminated within clinical and academic groups.
Adoption of opioid-prescribing guidelines in primary care: a realist synthesis of contextual factors
Authors: Jacobson Nora , Johnson Roberta A , Schlabach Christie , Incha Jillian , Madden Lynn , Almirall Daniel , Hennessey Garza Rose , Deyo Bri , Schumacher Nicholas , Stephenson Christine , Quanbeck Andrew
Published: December 2021

Objective

As part of an effort to design an implementation strategy tailoring tool, our research group sought to understand what is known about how contextual factors and prescriber characteristics affect the adoption of guideline-concordant opioid-prescribing practices in primary care settings.

Design

We conducted a realist synthesis of 71 articles.

Results

We found that adoption is related to contextual factors at the individual, clinic, health system and environmental levels, which operate via intrapersonal, interpersonal, organisational and structural mechanisms.

Conclusion

A single static model cannot capture the complexity of the relationships between contexts, mechanisms and outcomes. Instead, a deeper understanding requires a dynamic model that conceptualises clusters of contextual factors and mechanisms that tend towards guideline concordance and clusters that tend toward non-concordance.

Trail registration number

ClinicalTrial.gov registration numberNCT04044521.
Efficacy and safety of 1.5% aqueous olanexidine gluconate antiseptic solution compared to 1% alcoholic chlorhexidine for the prevention of intravenous catheter-related infections (Apollo study): a protocol for a randomised controlled trial
Authors: Yasuda Hideto , Kashiura Masahiro , Kishihara Yuki , Hifumi Toru , Abe Takayuki , Sasaki Junichi , Moriya Takashi , Morikane Keita , Shime Nobuaki
Published: December 2021

Introduction

Chlorhexidine alcohol (1.0%–2.0%) is currently recommended as a skin disinfectant to be used prior to catheterisation for preventing catheter-related infections. However, chlorhexidine alcohol has various side effects and has little antibacterial effect on methicillin-resistantStaphylococcus aureus(MRSA). Therefore, MRSA remains a concern for catheter-related bloodstream infection (CRBSI) prevention. Olanedine, containing 1.5% olanexidine gluconate in aqueous solution, was developed in Japan in 2015 and is structurally similar to chlorhexidine. Olanexine has been used as a disinfectant against various gram-positive and gram-negative bacteria and MRSA. This study aims to compare the efficacy of 1.5% aqueous olanexidine gluconate and 1% chlorhexidine alcohol as skin antiseptics for the prevention of catheter-related infections.

Methods and analysis

This Apollo study is an open-label, multicentre, non-inferiority, two-arm, parallel-group, randomised controlled trial conducted at 21 intensive care units (ICUs) and high-care units (HCUs) in Japan. All patients scheduled to be admitted to the ICU or HCU of a facility participating in this study, who require central venous catheter insertion are eligible. Eligible patients will be assigned to either the 1.5% aqueous olanexidine gluconate or 1% chlorhexidine alcohol group by randomisation in a ratio of 1:1 with stratification by centres. The antibacterial agents are to be used as a skin disinfectant before and during catheter placement. The primary endpoint is the proportion of catheter-related infections, defined as a composite of catheter-related sepsis without bacteraemia and CRBSI. A total of 1980 patients will be included in this study.

Ethics and dissemination

This clinical trial was approved by the Institutional Review Board of Jichi Medical University and the ethics committees of the participating institutions. The study results will be disseminated through conferences, peer-reviewed publications and meetings with interested parties.

Trial registration number

University hospital Medical Information Network (registration ID: UMIN000042343). This registration includes all items in the WHO Trial Registration Data Set.

Protocol version

This protocol corresponds to the original protocol version 5.
Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol
Authors: Ravera Francesco , Cirmena Gabriella , Dameri Martina , Gallo Maurizio , Vellone Valerio Gaetano , Fregatti Piero , Friedman Daniele , Calabrese Massimo , Ballestrero Alberto , Tagliafico Alberto , Ferrando Lorenzo , Zoppoli Gabriele
Published: December 2021

Introduction

Standard procedures aimed at the early diagnosis of breast cancer (BC) present suboptimal accuracy and imply the execution of invasive and sometimes unnecessary tissue biopsies. The assessment of circulating biomarkers for diagnostic purposes, together with radiomics, is of great potential in BC management.

Methods and analysis

This is a prospective translational study investigating the accuracy of the combined assessment of multiple circulating analytes together with radiomic variables for early BC diagnosis. Up to 750 patients will be recruited at their presentation at the Diagnostic Senology Unit of Ospedale Policlinico San Martino (Genoa, IT) for the execution of a diagnostic biopsy after the detection of a suspect breast lesion (t0). Each recruited patient will be asked to donate peripheral blood and urine before undergoing breast biopsy. Blood and urine samples will also be collected from a cohort of 100 patients with negative mammography. For cases with histological diagnosis of invasive BC, a second sample of blood and urine will be collected after breast surgery. Circulating tumour DNA, cell-free methylated DNA and circulating proteins will be assessed in samples collected at t0 from patients with stage I–IIA BC at surgery together with those collected from patients with histologically confirmed benign lesions of similar size and from healthy controls with negative mammography. These analyses will be combined with radiomic variables extracted with freeware algorithms applied to cases and matched controls for which digital mammography is available. The overall goal of the present study is to develop a horizontal data integration classifier for the early diagnosis of BC.

Ethics and dissemination

This research protocol has been approved by Regione Liguria Ethics Committee (reference number: 2019/75, study ID: 4452). Patients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals.

Trial registration number

NCT04781062.
Trends in energy and nutrient content of menu items served by large UK chain restaurants from 2018 to 2020: an observational study
Authors: Huang Yuru , Theis Dolly R Z , Burgoine Thomas , Adams Jean
Published: December 2021

Objective

The objective of this study was to evaluate the change in energy and nutrient content of menu items sold in large UK chain restaurants (eg, fast food, full service) from 2018 to 2020.

Design

Observational study.

Setting

Energy and nutritional information of menu items served by 29 large UK chain restaurants that consistently provided this information online in all three years. Data were collected in 2018 (March–April), 2019 (April) and 2020 (October–November) from restaurant websites.

Primary and secondary outcome measures

The per-item energy and nutrient (saturated fat, sugar and salt) changes in all items available on menus (‘all menu items’) and recurring items that were consistently available on menus in all three years (‘core menu items’), overall and in 12 different food categories.

Results

Our study included 7770, 9213 and 6928 menu items served by 29 large UK chain restaurants in 2018, 2019 and 2020, respectively. Our results showed that sugar content declined from 2018 to 2020 among all menu items (per-item: −0.43 g/year, 95% CI −0.66 to –0.21). This reduction in sugar was evident in beverages, sandwiches and desserts. Among core menu items (N=1855), sugar content reduced significantly from 2018 to 2020 (per-item: −0.31 g/year, 95% CI −0.45 to –0.17), especially in beverages. Energy, salt and saturated fat content in menu items remained constant overall, in both all menu items and core menu items. Fewer food categories had significant changes in energy, sugar, salt and saturated fat content among core menu items than among all menu items.

Conclusions

From 2018 to 2020, sugar content declined in restaurant menu items, which may reflect a response to the sugar reduction strategy and the effects of the soft drinks industry levy. In contrast, there was little change in other nutrients. Future policies addressing the overall nutritional quality of restaurant foods, rather than single nutrients, may help the restaurant sector move towards offering healthier foods.
Cohort profile: Japanese human milk study, a prospective birth cohort: baseline data for lactating women, infants and human milk macronutrients
Authors: Nojiri Keisuke , Higurashi Satoshi , Takahashi Tomoki , Tsujimori Yuta , Kobayashi Shunjiro , Toba Yasuhiro , Yamamura Jun-ichi , Nomura Kyoko , Ueno Hiroshi M
Published: December 2021

Purpose

The Japanese Human Milk Study, a longitudinal prospective cohort study, was set up to clarify how maternal health, nutritional status, lifestyle and sociodemographic and economic factors affect breastfeeding practices and human milk composition. This would eventually determine factors affecting the growth and development of infants and children.

Participants

A total of 1210 Japanese lactating women who satisfied the inclusion criteria, were invited across the country at various participating sites, between 2014 and 2019. Finally a total of 1122 women were enrolled in this study.

Findings to date

Among 1122 eligible participants, mean age at delivery was 31.2 (SD 4.4) years and mean prepregnancy BMI was 20.8 (SD 2.7). Among these women, 35% were previously nulliparous and 77.7% had college, university or higher education. The mean gestational period was 39.0 (SD 1.3) weeks. Caesarean section was reported among 11.9%; mean infant birth weight was 3082 (SD 360) g. Of the infants, 53.7% were male. Overall, our participants appeared to be healthier than the general population in Japan. Analyses of the 1079 eligible human milk samples obtained at the first and second months postpartum showed the following composition: carbohydrate, 8.13 (SD 0.32) g/100 mL; fat, 3.77 (SD 1.29) g/100 mL; and crude protein, 1.20 (SD 0.23) g/100 mL. We also analysed osteopontin, fatty acid, vitamin D and phospholipid levels in limited subcohorts of the samples.

Future plans

Follow-up surveys will be conducted to obtain milk samples every 2 months for 12 months and to investigate mother and child health until the children reach 5 years of age. These will be completed in 2024. We plan to longitudinally analyse the composition of macronutrients and various bioactive factors in human milk and investigate the lifestyle and environmental factors that influence breastfeeding practices, maternal and child health, and child development.

Trial registration number

UMIN000015494; pre-results.
Early development of primary care networks in the NHS in England: a qualitative mixed-methods evaluation
Authors: Parkinson Sarah , Smith Judith , Sidhu Manbinder
Published: December 2021

Objectives

Primary care networks (PCNs) were introduced in the National Health Service (NHS) in England in 2019 to improve integrated care for patients and help address financial and workforce sustainability issues in general practice. The purpose of this study was to collect early evidence on their implementation and development, including motivations to participate and what enables or inhibits progress. This paper considers the core characteristics of PCNs, and how this informs their management.

Design

A qualitative mixed-methods rapid evaluation was conducted across four case study sites in England, informed by a literature review and stakeholder workshop. Data collection comprised interviews, non-participant observation of meetings, an online survey and documentary review.

Results

General practitioners (GPs) are motivated to participate in PCNs for their potential to improve patient care, enable better coordinated services and enhance financial and workforce sustainability within primary care. However, PCNs also have an almost mandatory feel, based on the national policy context and significant financial incentives associated with joining them. PCNs offer potential to bring GPs together to work towards common goals, deliver national priorities and respond rapidly to local needs.

Conclusions

PCNs face similar challenges to other meso-level primary care organisations internationally, as they respond to local and national priorities and operate in a context of multiple goals and interests. In managing these organisations, it is important to find a balance between local and national autonomy, decision making and control.