bluuebunny/crossref_metadata_2025 huggingface dataset:
Acute myeloid leukaemia presenting as proptosis in an infant
Authors: Niazmand Mohammad Javad , Speckert Matthew , Johnston Donna
Published: December 2021

Paediatric patients with acute myeloid leukaemia (AML) often present with symptoms associated with the disruption of normal haematopoiesis and subsequent cellular deficiencies. Periosteal reactions are common in paediatric leukaemia, but typically manifest as a thin, laminated pattern along long bones. Aggressive periosteal reactions are much less frequently seen. Here, we report a case of paediatric AML initially presenting with proptosis and periorbital swelling caused by aggressive, sunburst periosteal reactions surrounding the sphenoid and zygomatic bones. This unique presentation emphasises the importance of considering leukaemic infiltration in the differential for sunburst periosteal reaction in paediatric patients.
Dashboards for visual display of patient safety data: a systematic review
Authors: Murphy Daniel R , Savoy April , Satterly Tyler , Sittig Dean F , Singh Hardeep
Published: December 2021

Background

Methods to visualise patient safety data can support effective monitoring of safety events and discovery of trends. While quality dashboards are common, use and impact of dashboards to visualise patient safety event data remains poorly understood.

Objectives

To understand development, use and direct or indirect impacts of patient safety dashboards.

Methods

We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched PubMed, EMBASE and CINAHL for publications between 1 January 1950 and 30 August 2018 involving use of dashboards to display data related to safety targets defined by the Agency for Healthcare Research and Quality’s Patient Safety Net. Two reviewers independently reviewed search results for inclusion in analysis and resolved disagreements by consensus. We collected data on development, use and impact via standardised data collection forms and analysed data using descriptive statistics.

Results

Literature search identified 4624 results which were narrowed to 33 publications after applying inclusion and exclusion criteria and consensus across reviewers. Publications included only time series and case study designs and were inpatient focused and emergency department focused. Information on direct impact of dashboards was limited, and only four studies included informatics or human factors principles in development or postimplementation evaluation.

Discussion

Use of patient-safety dashboards has grown over the past 15 years, but impact remains poorly understood. Dashboard design processes rarely use informatics or human factors principles to ensure that the available content and navigation assists task completion, communication or decision making.

Conclusion

Design and usability evaluation of patient safety dashboards should incorporate informatics and human factors principles. Future assessments should also rigorously explore their potential to support patient safety monitoring including direct or indirect impact on patient safety.
Efficacy and safety of stratified versus routine prophylaxis in living kidney transplantation from HBsAg+ donors to HBsAg− recipients: protocol for a multicentre, prospective, observational study
Authors: Wang Xianding , Yin Saifu , Song Turun , Huang Zhongli , Fan Yu , Liu Hongtao , Shang Wenjun , Zhou Honglan , Li Xiaohong , Lin Tao
Published: December 2021

Introduction

It remains unclear whether kidney transplantation (KT) from hepatitis B surface antigen (HBsAg) +donors to HBsAg− recipients (D(HBsAg+)/R(HBsAg−)) provides comparable transplant outcomes without hepatitis B virus (HBV) transmission compared with D(HBsAg−)/R(HBsAg−) KT. Moreover, no consensus has been reached for standardised prophylaxis regimens to prevent HBV transmission after D(HBsAg+)/R(HBsAg−) KT. We developed stratified prophylaxis regimens, including pretransplant antiviral treatment of donors, and pretransplant hepatitis B vaccination and post-transplant antiviral treatment of recipients, based on donors’ and recipients’ HBV serological characteristics. However, the safety and efficacy of stratified prophylaxis regimens remains unknown.

Methods and analysis

We are conducting a prospective, multicentre, observational study. Between September 2020 and December 2023, 100 cases of (D(HBsAg+)/R (HBsAg−)) KT will be recruited from four university-affiliated hospitals with a follow-up at least 2 years. They will naturally receive stratified prophylaxis regimens or routine prophylaxis based on clinical experience to compare the efficacy and safety of these two regimens in (D(HBsAg+)/R(HBsAg−)) KT. The primary outcome will be post-transplant HBV infection to evaluate safety, defined as post-transplant HBsAg−→+or HBV DNA−→+. The composite endpoint of prevention failure will be also an endpoint of safety (any one of HBsAg−→+, HBV DNA−→+, HB e antigen−→+, HB e antibody−→+ and HB c antibody−→+). The efficacy will be evaluated by transplant outcomes, including death-censored graft survival, patient survival, acute rejection, delayed graft function and kidney graft function.

Ethics and dissemination

This study will be registered as a clinical audit at each participating hospital and has obtained approval from the Ethics Committee of West China Hospital (reference: 2020-683, 8 September 2020).

Trial registration number

NCT04562051.
Patients’ experiences of medicines on initiation of antineoplastic agents for the treatment of colorectal cancer: a qualitative study
Authors: Brincat Alison , Vella Bonanno Patricia , Stewart Derek , Weidmann Anita E
Published: December 2021

Objective

To explore the patients’ experiences on initiation of treatment with antineoplastic medicines for colorectal cancer.

Design

A qualitative study using semistructured, face-to-face interviews based on the adapted patients’ lived experience with medicines conceptual model was conducted. Ethics approval was granted. Interviews took place while eligible patients were receiving their first cycle of antineoplastic medicines, audiorecorded and transcribed verbatim. Interpretative phenomenological analysis was used.

Setting

National oncology hospital in Malta.

Participants

Adult patients over 18 years, newly diagnosed with colorectal cancer and initiating treatment with 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX) or capecitabine plus oxaliplatin (XELOX) between October 2018 and September 2019 were recruited. Patients were included if fully aware of their diagnosis and the treatment being received. A purposive sample of 16 patients participated in the study.

Results

Five themes emerged from our analysis: (1) beliefs and knowledge on cancer and treatment; (2) healthcare system in relation to treatment; (3) medicine-taking practice; (4) medicine-related impact and (5) personal support structure. In addition, 16 subthemes were identified to describe the interplay of all aspects of the patients’ experiences on initiation of treatment with antineoplastic medicines.

Conclusion

This qualitative study illustrated that the patients find themselves in a complex situation on initiation of treatment with antineoplastic medicines. The patients’ knowledge on their specific treatment and active participation in making an informed decision need to be addressed. The healthcare system should develop tailored patient-centred services that specifically address the lack of patient empowerment and patient’s concern about treatment specific information.
Validation of visual estimation of neonatal jaundice in low-income and middle-income countries: a multicentre observational cohort study
Authors: Darmstadt Gary L , Hamer Davidson H , Carlin John B , Jeena Prakash M , Mazzi Eduardo , Narang Anil , Deorari A K , Addo-Yobo Emmanuel , Chowdhury MAK Azad , Kumar Praveen , Abu-Sarkodie Yaw , Yeboah-Antwi Kojo , Ray Pallab , Bartos Andres E , Saha Samir K , Foote Eric , Bahl Rajiv , Weber Martin W
Published: December 2021

Objective

Determine the sensitivity and specificity of neonatal jaundice visual estimation by primary healthcare workers (PHWs) and physicians as predictors of hyperbilirubinaemia.

Design

Multicentre observational cohort study.

Setting

Hospitals in Chandigarh and Delhi, India; Dhaka, Bangladesh; Durban, South Africa; Kumasi, Ghana; La Paz, Bolivia.

Participants

Neonates aged 1–20 days (n=2642) who presented to hospitals for evaluation of acute illness. Infants referred for any reason from another health facility or those needing immediate cardiopulmonary resuscitation were excluded.

Outcome measures

Infants were evaluated for distribution (head, trunk, distal extremities) and degree (mild, moderate, severe) of jaundice by PHWs and physicians. Serum bilirubin level was determined for infants with jaundice, and analyses of sensitivity and specificity of visual estimations of jaundice used bilirubin thresholds of >260 µmol/L (need for phototherapy) and >340 µmol/L (need for emergency intervention in at-risk and preterm babies).

Results

1241 (47.0%) neonates had jaundice. High sensitivity for detecting neonates with serum bilirubin >340 µmol/L was found for ‘any jaundice of the distal extremities (palms or soles) OR deep jaundice of the trunk or head’ for both PHWs (89%–100%) and physicians (81%–100%) across study sites; specificity was more variable. ‘Any jaundice of the distal extremities’ identified by PHWs and physicians had sensitivity of 71%–100% and specificity of 55%–95%, excluding La Paz. For the bilirubin threshold >260 µmol/L, ‘any jaundice of the distal extremities OR deep jaundice of the trunk or head’ had the highest sensitivity across sites (PHWs: 58%–93%, physicians: 55%–98%).

Conclusions

In settings where serum bilirubin cannot be measured, neonates with any jaundice on the distal extremities should be referred to a hospital for evaluation and management, where delays in serum bilirubin measurement and appropriate treatment are anticipated following referral, the higher sensitivity sign, any jaundice on the distal extremities or deep jaundice of the trunk or head, may be preferred.
Meibomian gland dysfunction and primary Sjögren’s syndrome dry eye: a protocol for systematic review and meta-analysis
Authors: Zi Changyan , Huang Qun , Ren Yuan , Yao Huan , He Tingting , Gao Yongxiang
Published: December 2021

Introduction

Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disorder that primarily affects the exocrine glands such as the lacrimal and the salivary glands. Dry eye disease (DED) is one of the most prevalent manifestations of pSS and is usually classified into aqueous-deficient dry eye and evaporative dry eye. Sjögren’s syndrome dry eye (SSDE) is generally described as aqueous-deficient dry eye. However, as the leading pathophysiological mechanism of evaporative dry eye, meibomian gland dysfunction (MGD) also has influence on SSDE, which has been shown in recent studies. We speculate that SSDE is more than just an aqueous-deficient dry eye. While no related systematic review and meta-analysis has been published, the present study is designed to derive a better understanding of the association between MGD and SSDE.

Methods and analysis

The Preferred Reporting items for Systematic Reviews and Meta-Analysis for Protocols 2015 statement was used to prepare this protocol. PubMed, Embase, Web of Science, Cochrane Database, China National Knowledge Infrastructure and Wan Fang Database will be searched from their inception to 31 October 2021, with restrictions to publications in English or Chinese. Two reviewers will independently carry out data extraction and quality assessment. The diagnosis of pSS will meet the standard diagnostic criteria, such as American College of Rheumatology/European League against Rheumatism Classification Criteria (ACR/EULAR) or American-European Consensus Group Classification criteria (AECG), and the definition of MGD and DED will differ between studies. The quality of included studies will be judged using the Newcastle-Ottawa Quality Scale. We will carry out this meta-analysis using RevMan V.5.4.1. The incidence of MGD in patients with SSDE will be indicated as OR with 95% CI.

Ethics and dissemination

Ethical approval is not required as this meta-analysis is performed based on published studies and does not involve human participants. The results will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42021226017.
Effectiveness and safety of yoga to treat chronic and acute pain: a rapid review of systematic reviews
Authors: Crevelário de Melo Roberta , Victoria Ribeiro Aline Ângela , Luquine Jr Cézar D , de Bortoli Maritsa Carla , Toma Tereza Setsuko , Barreto Jorge Otávio Maia
Published: December 2021

Background

Pain is a sensation of discomfort that affects a large part of the population. Yoga is indicated to treat various health conditions, including chronic and acute pain.

Objective

To evaluate the effectiveness and safety of yoga to treat acute or chronic pain in the adult and elderly population.

Study selection

A rapid review was carried out, following a protocol established a priori. Searches were carried out in September 2019, in six databases, using PICOS and MeSH (Medical Subject Headings) and DeCS (Descritores em Ciências da Saúde) terms. Systematic reviews were included, and methodological quality was assessed using Assessing the Methodological Quality of Systematic Reviews. The results were presented in a narrative synthesis.

Findings

Ten systematic reviews were selected. Two reviews were assessed as of high methodological quality, two as of low quality, and six of critically low quality. Results were favourable to yoga compared with usual daily care, particularly in low back and cervical pain cases. There was little evidence about the superiority of yoga compared with active interventions (exercises, pilates or complementary and complementary medicine). It was also less consistent in pain associated with fibromyalgia, osteoarthritis, rheumatoid arthritis, carpal tunnel and irritable bowel syndromes. There was an improvement in the quality of life and mood of the participants, especially for yoga compared with usual care, exercises and waiting list.

Conclusions

Overall, the results were favourable to yoga compared with usual care in low back and cervical pain cases. The evidence is insufficient to assert yoga’s benefits for other pain conditions, as well as its superiority over active interventions. The findings must be considered with caution, given their low methodological quality and the small samples in the primary studies reported in the included systematic reviews. Thus, more studies must be carried out to improve the reliability of the results.
Farm living and risk of asthma, atopic eczema, respiratory and food allergy: protocol for a systematic review and meta-analysis
Authors: Kuya Johnstone , Omoronyia Ogban , Fokukora Theopista , Emmanuel Aduroja Posi , Ewemooje Olusegun Sunday , Soyege Adewumni O , Ngo Valery , Anyiam Felix Emeka , Ackah Josephine Akua , Ossai-Chidi Linus , Manuel Beatriz , Okondu Ogechukwu Emmanuel , Nwaru Bright I
Published: December 2021

Introduction

Asthma and allergic disorders are of global concern and risk for their development results from the interplay of genetic and environmental factors. Among numerous environmental factors identified to influence the disease risk, the role of exposure to a farming environment has gained interest in recent times, but the underlying evidence is conflicting. The review aims to comprehensively identify, critically appraise and synthesise evidence from studies investigating the association between farm living and risk of asthma and allergic diseases in children and adults.

Methods and analysis

We will identify relevant analytical observational epidemiological studies, including cross-sectional, case-control and cohort studies, by searching PubMed, Cochrane Library, Google Scholar, Cumulative Index to Nursing and Allied Health Literature (CINAHL), WHO Global Health Library, Web of Science, Scopus and Embase. Screening of identified records, data extraction from eligible studies and risk of bias assssment of eligible studies will be independently undertaken by two reviewers, with arbitration by a third reviewer. The Effective Public Health Practice Project will be employed for the risk of bias assessment. Estimates from studies judged to be clinically, methodologically and statistically homogeneous will be synthesised using random-effects meta-analysis. Heterogeneity will be assessed using the I-squared statistic. We will consider objectively measured or self-reported asthma, atopic dermatitis/eczema, allergic rhinitis, wheeze, and food allergy as primary outcomes.

Ethics and dissemination

As this study is based solely on the published literature, no ethics approval is required. The study findings will be presented at scientific meetings related to the field of asthma and allergy and will be published in an international peer-reviewed scientific journal.

PROSPERO registration number

CRD42020208805.
Rates of surgical deaths and infections at district hospitals in Malawi and Zambia: a prospective multicentre cohort study
Authors: Gajewski Jakub , Zhang Mengyang , Bijlmakers Leon , Pittalis Chiara , Borgstein Eric , Mwapasa Gerald , Kachimba John , Cheelo Mweene , Waterman Kristen , Brugha Ruairi
Published: December 2021

Objective

This paper reports perioperative mortality and postoperative infection rates of surgical patients who underwent operations at district-level hospitals in Malawi and Zambia, and the associations of these outcomes with patient characteristics based on routinely available data.

Design

Prospective cohort study.

Setting

Eight government district hospitals in Malawi and nine mission and government district hospitals in Zambia.

Outcome measures

Perioperative mortality and postoperative infection were used as primary outcome measures in this study. Logistic regression and penalised maximum likelihood logistic regression were used to examine the factors correlated with surgical outcomes.

Results

The average perioperative mortality rates were 0.19% and 0.43% in Malawi and Zambia, respectively. Penalised maximum likelihood logistic regression showed that age (OR=1.046, 95% CI 1.016 to 1.078) and American Society of Anesthesiologists physical status score II (OR=6.658, 95% CI 2.363 to 18.762) were significantly associated with perioperative deaths. General surgery procedures were significantly more likely than obstetrical procedures to result in perioperative deaths (OR=3.821, 95% CI 1.226 to 11.908). The average rates of postoperative infections in Malawi and Zambia were 2.69% and 2.24%, respectively. Age (OR=1.010, 95% CI 1.000 to 1.020) and male sex (OR=0.407, 95% CI 0.260 to 0.637) were significantly associated with postoperative infections. Additional factors, general procedures (OR=2.319, 95% CI 1.397 to 3.850) and trauma-related procedure (OR=5.490, 95% CI 2.632 to 11.449) were significantly associated with infection rates. There was no significant correlation between surgical outcomes and cadre of lead surgeon (a non-physician clinician or doctor).

Conclusion

Rates of mortality and postoperative infections in this sample of district-level hospitals in Malawi and Zambia were relatively low, with poorer preoperative physical status as the main predictor of both greater postoperative infection and mortality. The study demonstrates that outcomes of major surgical cases do not depend on the cadre (type) of surgeon performing it, and outcomes can be monitored using routine data, at district level in these countries.

Trial registration number

ISRCTN66099597.
Cohort profile: Copenhagen Hospital Biobank - Cardiovascular Disease Cohort (CHB-CVDC): Construction of a large-scale genetic cohort to facilitate a better understanding of heart diseases
Authors: Laursen Ina H , Banasik Karina , Haue Amalie D , Petersen Oscar , Holm Peter C , Westergaard David , Bundgaard Henning , Brunak Søren , Frikke-Schmidt Ruth , Holm Hilma , Sørensen Erik , Thørner Lise W , Larsen Margit A H , Schwinn Michael , Køber Lars , Torp-Pedersen Christian , Ostrowski Sisse R , Erikstrup Christian , Nyegaard Mette , Stefánsson Hreinn , Gylfason Arnaldur , Zink Florian , Walters G Bragi , Oddsson Asmundur , Þorleifsson Guðmar , Másson Gisli , Thorsteinsdottir Unnur , Gudbjartsson Daniel , Pedersen Ole B , Stefánsson Kári , Ullum Henrik
Published: December 2021

Purpose

The aim of Copenhagen Hospital Biobank-Cardiovascular Disease Cohort (CHB-CVDC) is to establish a cohort that can accelerate our understanding of CVD initiation and progression by jointly studying genetics, diagnoses, treatments and risk factors.

Participants

The CHB-CVDC is a large genomic cohort of patients with CVD. CHB-CVDC currently includes 96 308 patients. The cohort is part of CHB initiated in 2009 in the Capital Region of Denmark. CHB is continuously growing with ~40 000 samples/year. Patients in CHB were included in CHB-CVDC if they were above 18 years of age and assigned at least one cardiovascular diagnosis. Additionally, up-to 110 000 blood donors can be analysed jointly with CHB-CVDC. Linkage with the Danish National Health Registries, Electronic Patient Records, and Clinical Quality Databases allow up-to 41 years of medical history. All individuals are genotyped using the Infinium Global Screening Array from Illumina and imputed using a reference panel consisting of whole-genome sequence data from 8429 Danes along with 7146 samples from North-Western Europe. Currently, 39 539 of the patients are deceased.

Findings to date

Here, we demonstrate the utility of the cohort by showing concordant effects between known variants and selected CVDs, that is, >93% concordance for coronary artery disease, atrial fibrillation, heart failure and cholesterol measurements and 85% concordance for hypertension. Furthermore, we evaluated multiple study designs and the validity of using Danish blood donors as part of CHB-CVDC. Lastly, CHB-CVDC has already made major contributions to studies of sick sinus syndrome and the role of phytosterols in development of atherosclerosis.

Future plans

In addition to genetics, electronic patient records, national socioeconomic and health registries extensively characterise each patient in CHB-CVDC and provides a promising framework for improved understanding of risk and protective variants. We aim to include other measurable biomarkers for example, proteins in CHB-CVDC making it a platform for multiomics cardiovascular studies.
Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
Authors: Bolou Angeliki , Lanz Doris , Drymoussi Zoe , Gonzalez Carreras Francisco Jose , Austin Frances , Dodds Julie , Mehay Anita , Pizzo Elena , Thomas Amy , Heighway James , Sanghi Anita , Harden Angela , Pérez Teresa , Pardo Llorente Maria del Carmen , Hitman Graham , Huda Mohammed SB , Thangaratinam Shakila
Published: December 2021

Introduction

Women with gestational diabetes are at increased risk of developing type 2 diabetes later in life. In at-risk general populations, Mediterranean-style diet helps prevent type 2 diabetes. But its effect on postnatal women with a history of gestational diabetes is not known. Prior to a full-scale trial on Mediterranean-style diet in the postnatal period to prevent type 2 diabetes, a feasibility study is required to assess the acceptability of the diet and evaluate the trial processes.

Methods and analysis

MEditerranean diet for pReventIon of type 2 diabeTes is a single-arm feasibility study (65 women) with qualitative evaluation of women who have recently given birth and had gestational diabetes. The intervention is a Mediterranean-style diet supplemented with nuts and olive oil, with dietary advice and an action plan. A dedicated Health Coach will interact with participants through an interactive lifestyle App. Women will follow the intervention from 6 to 13 weeks post partum until 1 year post partum. The primary outcomes are rates of recruitment, follow-up, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes, and acceptability of the intervention to participants, and to healthcare professionals delivering the intervention. Feasibility outcomes will be reported using descriptive statistics.

Ethics and dissemination

Ethical approval was obtained through the South Central—Berkshire Research Ethics Committee (19/SC/0064). Study findings will be disseminated via publication in peer-reviewed journals, as well as via newsletters made available to participants and members of Katie’s Team (a women’s health patient and public advisory group).

Trial registration number

ISRCTN40582975.
Exploring the experiences of stroke survivors, informal caregivers and healthcare providers in Sierra Leone: a qualitative study protocol
Authors: O'Hara Jessica , Thompson Melvina , Deen Gibrilla , Leather Andrew J M , Youkee Daniel , Wall Jurate , Sackley Catherine , Parmar Divya , McKevitt Christopher
Published: December 2021

Introduction

Stroke is now the second leading cause of adult death in Sub-Saharan Africa. Developed in dialogue with stroke survivors and caregivers in Sierra Leone, this will be the first study to explore the experience of stroke as well as the perceptions of the barriers and facilitators to accessing stroke care among stroke survivors, informal caregivers and healthcare providers. Findings will inform future stroke research and care in Sierra Leone.

Methods and analysis

A cross-sectional qualitative study employing semistructured interviews that will be audiorecorded, translated, transcribed and coded.

Setting

Freetown, Sierra Leone.

Participants

Interviews with a purposive sample of stroke survivors, informal caregivers and healthcare providers.

Analysis

Interviews will be coded by two authors and inductively analysed using thematic analysis.

Ethics and dissemination

This study has received ethical approval from the Sierra Leone Ethics and Scientific Review Committee (8 December 2020) and the KCL Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee (reference: HR-20/21-21050). The findings of the study and learning in terms of the process of coproduction and involvement of stroke survivors will be disseminated via peer-reviewed publications, conferences, media and lay reports.
‘…you just put up with it for the sake of humanity.’: an exploratory qualitative study on causes of stress in palliative care nursing during the COVID-19 pandemic in Germany
Authors: May Susann , Stahlhut Kerstin , Allsop Matthew , Heinze Martin , Mühlensiepen Felix
Published: December 2021

Objective

To explore and analyse causes of stress among nurses in palliative and inpatient hospice care settings in Germany during the COVID-19 pandemic.

Design

Explorative, qualitative study using problem-centred interviews. Interview data were analysed using structured qualitative content analysis.

Setting

Telephone interviews with nurses of different settings of palliative and inpatient hospice care.

Participants

16 nurses from inpatient hospice, palliative care units and specialised palliative home care were recruited.

Results

COVID-19 infection control measures placed both physical and psychological strain on palliative care nurses. Due to changes in infection control information, workflows were being readjusted on a daily basis, preventing everyday routines and hindering relief from stress. There are reduced and limited opportunities for sharing and reflecting on daily working routines with team colleagues. Specific causes of stress in the individual settings of palliative and inpatient hospice care were identified. Overall, there is a tension between the nurses’ perceptions of proper palliative care nursing, in terms of closeness, psychosocial and emotional support and compliance with infection control measures.

Conclusions

Palliative care nurses have been exposed to high levels of both physical and psychological stress during the COVID-19 pandemic. This requires rapid relief and support, with a need to ensure continuity of professional supervision and peer-support, which may be facilitated via digital technologies. The unique role of nurses in inpatient hospice and palliative care during COVID-19 ought to be recognised and valorised.
Gaps in antihypertensive and statin treatments and benefits of optimisation: a modelling study in a 1 million ethnically diverse urban population in UK
Authors: Wu Runguo , Rison Stuart Christopher Gorthorn , Raisi-Estabragh Zahra , Dostal Isabel , Carvalho Chris , Robson John , Mihaylova Borislava
Published: December 2021

Objectives

To characterise gaps in antihypertensive treatment in people with hypertension and statin treatment in people with cardiovascular diseases (CVD) in a large urban population and quantify the health and economic impacts of their optimisation.

Design

A cross-sectional population study and a long-term CVD decision model.

Setting

Primary care, UK.

Participants

All adults with diagnosed hypertension or CVD in a population of about 1 million people, served by 123 primary care practices in London, UK in 2019.

Interventions

Following UK clinical guidelines, all adults with diagnosed hypertension were categorised into optimal, suboptimal and untreated groups with respect to their antihypertensive treatment, and all adults with diagnosed CVD were categorised in the same manner with respect to their statin treatment.

Outcomes

Proportion of patients suboptimally treated or untreated. Projected cardiovascular events avoided, years and quality-adjusted life years (QALYs) gained and healthcare costs saved with optimised treatments.

Results

21 954 of the 91 828 adults with hypertension (24%; mean age 59 years; 49% women) and 9062 of the 23 723 adults with CVD (38%; mean age 69 years; 43% women) were not optimally treated with antihypertensive or statin treatment, respectively. Per 1000 additional patients optimised over 5 years, hypertension treatment is projected to prevent 25 (95% CI 16 to 32) major vascular events (MVEs) and 7 (3 to 10) vascular deaths, statin treatment, 28 (22 to 33) MVEs and 6 (4 to 7) vascular deaths. Over their lifespan, a patient with uncontrolled hypertension aged 60–69 years is projected to gain 0.64 (95% CI 0.36 to 0.87) QALYs with optimised hypertension treatment, and a similarly aged patient with previous CVD not optimally treated with statin is projected to gain 0.3 (0.24 to 0.37) QALYs with optimised statin treatment. In both cases, the hospital cost savings minus extra medication costs were about £1100 per person over remaining lifespan.

Conclusions

Optimising cardiovascular treatments can cost-effectively reduce cardiovascular risk and improve life expectancy.
Short-term oestrogen as a strategy to prevent postpartum depression in high-risk women: protocol for the double-blind, randomised, placebo-controlled MAMA clinical trial
Authors: Høgh Stinne , Hegaard Hanne Kristine , Renault Kristina Martha , Cvetanovska Eleonora , Kjærbye-Thygesen Anette , Juul Anders , Borgsted Camilla , Bjertrup Anne Juul , Miskowiak Kamilla Woznica , Væver Mette Skovgaard , Stenbæk Dea Siggaard , Dam Vibeke Høyrup , Binder Elisabeth , Ozenne Brice , Mehta Divya , Frokjaer Vibe G
Published: December 2021

Introduction

Postpartum depression affects 10%–15% of women and has a recurrence rate of 40% in subsequent pregnancies. Women who develop postpartum depression are suspected to be more sensitive to the rapid and large fluctuations in sex steroid hormones, particularly estradiol, during pregnancy and postpartum. This trial aims to evaluate the preventive effect of 3 weeks transdermal estradiol treatment immediately postpartum on depressive episodes in women at high risk for developing postpartum depression.

Methods and analysis

The Maternal Mental Health Trial is a double-blind, randomised and placebo-controlled clinical trial. The trial involves three departments of obstetrics organised under Copenhagen University Hospital in Denmark. Women who are singleton pregnant with a history of perinatal depression are eligible to participate. Participants will be randomised to receive either transdermal estradiol patches (200 µg/day) or placebo patches for 3 weeks immediately postpartum. The primary outcome is clinical depression, according to the Diagnostic and Statistical Manual of Mental Disorders-V criteria of Major Depressive Disorder with onset at any time between 0 and 6 months postpartum. Secondary outcomes include, but are not limited to, symptoms of depression postpartum, exclusive breastfeeding, cortisol dynamics, maternal distress sensitivity and cognitive function. The primary statistical analysis will be performed based on the intention-to-treat principle. With the inclusion of 220 participants and a 20% expected dropout rate, we anticipate 80% power to detect a 50% reduction in postpartum depressive episodes while controlling the type 1 error at 5%.

Ethics and dissemination

The study protocol is approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Centre for Data Protection Compliance in the Capital Region of Denmark. We will present results at scientific meetings and in peer-reviewed journals and in other formats to engage policymakers and the public.

Trial registration number

NCT04685148.
Health-related quality of life in postcardiac interventional catheterization patients with congenital heart disease: a mixed-methods study protocol from Pakistan
Authors: Ali Fatima , Ladak Laila Akbar , Usmani Asra Abeer , Raza Hussain Ahmed , Siddiqui Marium Tariq , Hasan Babar
Published: December 2021

Introduction

Improvement in health-related quality of life (HRQoL) has been reported in patients with congenital heart disease treated with interventional cardiac catheterization; however, there is a significant dearth of literature from low/middle-income countries (LMICs) about this aspect. Multiple factors like sociodemographic and cultural differences, variable procedural outcomes due to lack of technical expertise and limited resources and inconsistent postprocedure follow-up may affect HRQoL in LMICs. This protocol paper aims to describe the study methodology to determine the HRQoL and its predictors in patients who have undergone interventional cardiac catheterization. Conclusions from this protocol study will help prepare a holistic approach to delivering care to patients in low-resource settings.

Methods and analysis

A mixed-methods study design will be used. The quantitative arm will compare the HRQoL of these postcardiac interventional catheterization patients with their age-matched healthy siblings to identify the HRQoL predictors, whereas the qualitative arm will further explore the experiences of these patients and parents. A minimum number of 108 patients of age 2 years and above, at least 6 months postinterventional catheterization follow-up and ability to understand Urdu/English will be enrolled. PedsQL 4.0 Generic Core Scales, PedsQL Cognitive Functioning Scale and PedsQL 3.0 Cardiac Module will be used. The Student’s t-test will analyse the difference in the means of HRQoL between patients and siblings. Multiple regression will identify HRQoL predictors. A subsample of enrolled patients and parents will be interviewed and analysed using directed content analysis (a qualitative component of the study).

Ethics and dissemination

Ethics approval has been obtained from Ethics Review Committee of The Aga Khan University, Pakistan (ERC #2020-3456-11808). Study findings will be published in peer-reviewed journals and presented at conferences.
Maternal use of cough medications during early pregnancy and selected birth defects: a US multisite, case–control study
Authors: Cao Yanyan , Rhoads Anthony , Burns Trudy , Carnahan Ryan M , Conway Kristin M , Werler Martha M , Mitchell Allen , Romitti Paul
Published: December 2021

Objective

To examine associations between maternal use of cough medications containing dextromethorphan (DM) without guaifenesin (glyceryl guaiacolate (GG)) (‘DM alone’), GG without DM (‘GG alone’) or DM +GG and major birth defects in offspring.

Design

Population-based case–control study.

Setting

The multisite, US National Birth Defects Prevention Study.

Participants

Mothers of 1644 children with neural tube defects (NTDs), 15 110 with non-NTDs, and 10 671 control children without a birth defect diagnosis.

Main outcome measures

ORs and 95% CIs.

Results

For NTD analysis, 1.7% of mothers of case children and 1.2% of mothers of control children reported using DM alone, 1.1% and 0.6% GG alone, and 0.4% and 0.2% DM +GG. Respective percentages for non-NTD analysis were 2.2% and 1.9% for DM alone, 1.7% and 1.6% for GG alone, and 0.5% and 0.4% for DM +GG. For all NTDs and subtypes, adjusted OR estimates for DM alone were near the null with 95% CIs that included 1.0. Estimates (95% CI) were 1.8 (1.0 to 3.3) for GG alone and 1.8 (0.6 to 4.8) for DM +GG with all NTDs and 2.2 (1.1 to 4.3) for GG alone with spina bifida. Of the 45 adjusted OR estimates for non-NTDs, 39 ranged from 0.5 to 1.6 with 95% CIs that included 1.0. Near twofold or higher estimates (95% CI) were observed for the remainder and included 1.9 (1.0 to 3.7) for hydrocephalus, 2.9 (1.3 to 6.5) for atrioventricular septal defect and 1.8 (1.1 to 3.0) for transverse limb deficiency with DM alone; 2.1 (1.1 to 4.0) for small intestinal atresia/stenosis and 2.1 (0.9 to 4.5) for omphalocele with GG alone; and 3.2 (1.5 to 6.9) for gastroschisis with DM +GG.

Conclusions

Maternal use of medications containing DM alone, GG alone or DM +GG showed positive associations with a small number of birth defects. These observations, which should be interpreted with caution due to small proportions of exposed mothers, may represent true signals or chance findings and warrant evaluation in future studies.
Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
Authors: Verzelloni Jessica , Errante Antonino , Beccani Laura , Filippi Mariacristina , Bressi Barbara , Cavuto Silvio , Ziccarelli Settimio , Bozzetti Francesca , Costi Stefania , Pineschi Elena , Fogassi Leonardo , Ferrari Adriano
Published: December 2021

Introduction

Action Observation Treatment (AOT) is an innovative therapeutic approach consisting in the observation of actions followed by subsequent repetition. In children with unilateral cerebral palsy (UCP), it improves upper limb function in daily activities. The standard paradigm of AOT requires the observation of healthy models; however, it has been demonstrated that the mirror neuron system of children with UCP is more activated by observation of pathological models, showing a similar motor repertoire, than by the healthy model, suggesting that AOT based on pathological models is superior to the standard paradigm of AOT in the functional rehabilitation of the affected upper limb of children with UCP.

Methods and analysis

This protocol describes an active two-arm randomised controlled evaluator-blinded trial. Twenty-six children with UCP will participate in 3 weeks of intensive AOT: the experimental group will observe a pathological model, while the control group will observe a typically developed model. The primary outcome is the spontaneous use of the paretic hand, measured with the Assisting Hand Assessment. Secondary outcome measures are the Melbourne Assessment of Unilateral Upper Limb Function, the ABILHAND-Kids and the Activities Scale for Kids-performance. Assessments will be performed at baseline (T0), at the end of intensive AOT (T1), at 8–12 weeks (T2) and at 24–28 weeks (T3) after the end of intensive AOT.

Ethics and dissemination

The trial was approved by the Area Vasta Emilia Nord Ethics Committee (AVEN prot. n. 133117, 29 November 2018), and it was prospectively registered on ClinicalTrials.gov. The results will be submitted for publication to a peer-reviewed journal, discussed with parents of children participating in the trial and disseminated at suitable conferences.

Trial registration number

NCT04088994; Pre-results.
Readiness of health facilities and determinants to manage diabetes mellitus: evidence from the nationwide Service Provision Assessment survey of Afghanistan, Bangladesh and Nepal
Authors: Huda Md Durrul , Rahman Mosiur , Rahman Md Mosfequr , Islam Md Jahirul , Haque Syed Emdadul , Mostofa Md Golam
Published: December 2021

Objectives

Using nationally representative surveys, the study’s aims were to: (1) evaluate healthcare facilities’ readiness to provide diabetes mellitus (DM) services and (2) identify the factors that affect DM service readiness.

Data source

Data from Service Provision Assessment surveys conducted in three low-resource South Asian (SA) countries: Afghanistan, Bangladesh and Nepal, were used in this study.

Design

Cross-sectional nationally representative survey

Participants

A total of 117, 317 and 397 public and private health facilities in Afghanistan, Bangladesh and Nepal, respectively were analysed.

Primary outcome

A total of 12 items/indicators were used to measure a health facility’s readiness to provide DM services across four domains.

Results

For DM management, about 39.3%, 58.4% and 58.2% of health facilities in Afghanistan, Bangladesh and Nepal centred around 7–8, 3–6 and 4–6 items. Only 12.8%, 5.0% and 4.8% of healthcare facilities in Afghanistan, Bangladesh and Nepal reported having at least % (9/12) of the necessary items for DM management, and no one reported having all 12 important items for DM management. According to the negative binomial regression models, the factors associated with higher readiness scores vary among the three countries analysed. Regression models also showed that increases in the number of DM care providers and facility types are similar factors linked to increased readiness scores in all three countries.

Conclusions

In order to increase a health facility’s readiness to offer DM care, country-specific factors must be addressed in addition to common factors found in all three countries. Further research is required to determine the cause of country-level differences in tracer item availability in order to develop targeted and effective country-specific strategies to improve care quality in the SA region.
Cross-sectional study of chronic hepatitis B virus infection in Rwandan high-risk groups: unexpected findings on prevalence and its determinants
Authors: Umutesi Justine , Klett-Tammen Carolina , Nsanzimana Sabin , Krause G , Ott J J
Published: December 2021

Objectives

Using secondary data from 208 079 Rwandans, we determined the prevalence of chronic hepatitis B virus (HBV) infection among high-risk groups and its demographic, geographical and health-related determinants.

Design

In this cross-sectional study, we obtained and analysed data from a national hepatitis B vaccination and screening campaign conducted in Rwanda in 2017. We performed logistic regression to examine associations between chronic HBV infection and related factors such as risk status and geographical characteristics.

Setting

Individuals were sampled nationally in all 30 districts across 4 provinces and the city of Kigali and all prisons in Rwanda.

Participants

The study involves 208 079 individuals at high risk including prisoners and other high-risk groups (oHRG).

Main outcome

The primary outcome for our study was hepatitis B surface antigens (HBsAg) prevalence.

Findings

From 208 079 adults participants, 206 517 (99.2%) had valid HBsAg results, 4.3% of 64 944 prisoners and 4.0% of 140 985 oHRG were HBV positive. The prevalence was higher in Northern Province 5.1%, (95% CI 4.8 to 5.4). In multivariate analysis, the odds of infection decreased with increasing age, and hepatitis C antibody positivity reduced the odds for chronic HBV (OR 0.58, 95% CI 0.52 to 0.66 and OR 0.74, 95% CI 0.62 to 0.89 among oHRG and prisoners, respectively). In addition, being female was associated with lower odds of HBV (OR 0.70, 95% CI 0.66 to 0.74 and OR 0.80, 95% CI 0.65 to 0.98 among oHRG and prisoners, respectively).

Conclusion

We found that individuals below 55 years of age and individuals who belong to high-risk groups (ie, sex workers, injection drug users, men who have sex with men, etc) have a higher probability of chronic HBV infection. Infection with chronic hepatitis C virus was not correlated with chronic HBV infection in our study population. Potential explanations include differential routes of transmission, specific immunological and pathophysiological factors or different effects of health prevention and control programmes.
Vision-specific risk factors impacting self-rated health among older men in urban China: a population-based cross-sectional study
Authors: Yang Wei , Han Jinsong , Wang Bowen , Zhang Tianjiao , Sun Wei
Published: December 2021

Background

Self-rated health (SRH) has been well documented as an important assessment of health status among the older adults. Interestingly, visual ability has been reported to have a considerable impact on the quality of life of the older adults. This study clarified vision-specific risk factors impacting SRH among older men without cognitive impairment in order to optimise healthcare for the older adults.

Methods

A population-based cross-sectional study was conducted in urban areas of Liaoning Province. A stratified sampling method was used and all men aged ≥65 years and living in sampled communities without dementia were interviewed between March and November 2012. SRH, visual ability and factors including demographic characteristics, physical conditions, lifestyle factors, social psychological factors and social activities, were measured. 1884 effective responses were received (effective response rate, 84.8%) and 1724 individuals were enrolled after further cognitive screening.

Results

The mean age was 72.9±5.9 (mean±SD). Of individuals with good and poor visual ability, 38.3% and 33.0% reported good SRH, respectively. The characteristics between different visual ability groups were significantly different. Interactions between visual ability and four items had significant effects on SRH. In good visual ability group, chronic disease had the strongest association with good SRH followed by participating in entertainment, taking a walk, filial piety and alcohol consumption. In poor visual ability group, taking a walk had the strongest association with good SRH followed by participating in entertainment, hearing ability, smoking, quality of sleep, going out alone to distant places and alcohol consumption.

Conclusions

A good SRH status, even among the individuals with good visual ability, had a low prevalence among older men in urban areas. The risk factors impacting SRH was vision-specific. Physical conditions were crucial for SRH among those with good visual ability. In contrast, lifestyle factors were prominent for those with poor visual ability.