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Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN)

by Yue Liao, Susan M. Schembre, Grace E. Brannon, Zui Pan, Jing Wang, Sadia Ali, M. Shaalan Beg, Karen M. Basen-Engquist

Regular physical activity reduces the progression of several cancers and offers physical and mental health benefits for cancer survivors. However, many cancer survivors are not sufficiently active to achieve these health benefits. Possible biological mechanisms through which physical activity could affect cancer progression include reduced systemic inflammation and positive changes in metabolic markers. Chronic and acute hyperglycemia could have downstream effects on cell proliferation and tumorigenesis. One novel strategy to motivate cancer survivors to be more active is to provide personalized biological-based feedback that demonstrates the immediate positive impact of physical activity. Continuous glucose monitors (CGMs) have been used to demonstrate the acute beneficial effects of physical activity on insulin sensitivity and glucose metabolisms in controlled lab settings. Using personal data from CGMs to illustrate the immediate impact of physical activity on glucose patterns could be particularly relevant for cancer survivors because they are at a higher risk for developing type 2 diabetes (T2D). As a pilot project, this study aims to (1) test the preliminary effect of a remotely delivered physical activity intervention that incorporates personalized biological-based feedback on daily physical activity levels, and (2) explore the association between daily glucose patterns and cancer-related insulin pathway and inflammatory biomarkers in cancer survivors who are at high risk for T2D. We will recruit 50 insufficiently active, post-treatment cancer survivors who are at elevated risk for T2D. Participants will be randomly assigned into (1) a group that receives personalized biological feedback related to physical activity behaviors; and (2) a control group that receives standard educational material. The feasibility and preliminary efficacy of this wearable sensor-based, biofeedback-enhanced 12-week physical activity intervention will be evaluated. Data from this study will support the further refinement and enhancement of a more comprehensive remotely delivered physical activity intervention that targets cancer survivors. Trial registration: ClinicalTrials.gov Identifier: NCT05490641.

Minimum inhibitory concentrations of rifampin and isoniazid among multidrug and isoniazid resistant <i>Mycobacterium tuberculosis</i> in Ethiopia

by Muluwork Getahun, Henry M. Blumberg, Gobena Ameni, Dereje Beyene, Russell R. Kempker

Introduction

Traditionally, single critical concentrations of drugs are utilized for Mycobacterium tuberculosis (Mtb) drug susceptibility testing (DST); however, the level of drug resistance can impact treatment choices and outcomes. Mutations at the katG gene are the major genetic mutations in multidrug resistant (MDR) Mtb and usually associated with high level resistance. We assessed the minimum inhibitory concentrations (MICs) of MDR or rifampin resistant (RR) and isoniazid (INH) resistant Mtb isolates to determine the quantification of drug resistance among key anti-tuberculosis drugs.

Methods

The study was conducted on stored Mtb isolates collected as part of a national drug resistance survey in Ethiopia. MIC values were determined using Sensititre MYCOTB plates. A line probe assay (MTBDRplus) was also performed to identify genetic determinants of resistance for all isolates.

Results

MIC testing was performed on 74 Mtb isolates including 46 MDR, 2 RR and 26 INH phenotypically resistant isolates as determined by the Löwenstein Jensen (LJ) method. Four (15%) INH resistant Mtb isolates were detected as borderline rifampin resistance (MIC = 1 μg/ml) using MYCOTB MIC plates and no rifampin resistance mutations were detected by LPA. Among the 48 MDR/RR TB cases, 9 (19%) were rifabutin susceptible (MIC was between ≤0.25 and 0.5μg/ml). Additionally, the MIC for isoniazid was between 2–4 μg/ml (moderate resistance) for 58% of MDR TB isolates and 95.6% (n = 25) of the isolates had mutations at the katG gene.

Conclusion

Our findings suggest a role for rifabutin treatment in a subset of RR TB patients, thus potentially preserving an important drug class. The high proportion of moderate level INH resistant among MDR Mtb isolates indicates the potential benefit of high dose isoniazid treatment in a high proportion of katG gene harboring MDR Mtb isolates.

COVID-19 vaccine acceptance and perceived risk among pregnant and non-pregnant adults in Cameroon, Africa

by Nuwan Gunawardhana, Kendall Baecher, Alexander Boutwell, Seraphine Pekwarake, Mirabelle Kifem, Mary Glory Ngong, Anthony Fondzeyuf, Gregory Halle-Ekane, Rahel Mbah, Pius Tih, Jodie Dionne-Odom, Denis M. Tebit

Background

The public health response to the global COVID-19 pandemic has varied widely by region. In Africa, uptake of effective COVID-19 vaccines has been limited by accessibility and vaccine hesitancy. The aim of this study was to compare perceptions of COVID-19 infection and vaccination between pregnant women and non-pregnant adults in four regions of Cameroon, located in Central Africa.

Methods

A cross-sectional survey study was conducted at urban and suburban hospital facilities in Cameroon. Participants were randomly selected from a convenience sample of adult pregnant and non-pregnant adults in outpatient clinical settings between June 1st and July 14th, 2021. A confidential survey was administered in person by trained research nurses after obtaining written informed consent. Participants were asked about self-reported sociodemographics, medical comorbidities, perceptions of COVID-19 infection, and vaccination. Descriptive statistics were used for survey responses and univariate and multivariable logistic regression models were created to explore factors associated with COVID-19 vaccine acceptability.

Results

Fewer than one-third of participants were interested in receiving the COVID-19 vaccine (31%, 257/835) and rates did not differ by pregnancy status. Overall, 43% of participants doubted vaccine efficacy, and 85% stated that the vaccine available in Africa was less effective than vaccine available in Europe. Factors independently associated with vaccine acceptability included having children (aOR = 1.5; p = 0.04) and higher education (aOR = 1.6 for secondary school vs primary/none; p = 0.03). Perceived risks of vaccination ranged from death (33%) to fetal harm (31%) to genetic changes (1%). Health care professionals were cited as the most trusted source for health information (82%, n = 681).

Conclusion

COVID-19 vaccine hesitancy and misinformation in Cameroon was highly prevalent among pregnant and non-pregnant adults in 2021 while vaccine was available but not recommended for use in pregnancy. Based on study findings, consistent public health messaging from medical professionals about vaccine safety and efficacy and local production of vaccine are likely to improve acceptability.

Systematic review, meta‐analysis and meta‐regression to determine the effects of patient education on health behaviour change in adults diagnosed with coronary heart disease

Abstract

Aims and Objectives

To assess the effectiveness of educational interventions and the relative effect of intervention duration on secondary prevention health behaviours in adults with coronary heart disease.

Background

Patient education can reduce disease progression and improve outcomes. However, there is a lack of knowledge of its efficacy and the relative impact of education duration on health behaviour change in this population.

Design

A systematic review and meta-analysis.

Methods

Seven electronic databases and grey literature were searched from Inception to July 2021. The review followed the PRISMA guidelines. This meta-analysis was analysed in Comprehensive Meta-Analysis version 3 software. Outcomes considered were disease knowledge and health behavioural outcomes. Data were pooled together with random-effects models using the inverse-variance method. The effect of education duration (<3 vs. ≥3 months) was examined by meta-regressions.

Results

In summary, 73 studies were included with a total of participants (n = 24,985) aged mean of 60.5 ± 5.7 years and mostly male (72.5%). Patient education improved all behaviours including disease knowledge at <6 and 6–12 months follow-up, the likelihood of quitting smoking at <6, and 6–12 months, medication adherence at <6 and 6–12 months; physical activity and exercise participation at <6 and 6–12 months and healthy dietary behaviours, at <6 and 6–12 months. Furthermore, education programmes with a longer duration (≥3 months) improved disease knowledge and physical activity more than shorter programmes.

Conclusion

Patient education for secondary prevention, in various delivery modes and intensities, improves multiple self-reported health behaviours in patients with coronary heart disease.

Relevance to clinical practice

This study assessed the effectiveness of secondary prevention education and demonstrated improvements in all outcomes in this population. Longer duration programmes were more effective in improving disease knowledge and physical activity in the long term. These findings can assist the cardiac programmes’ design, particularly in ensuring sufficient intervention duration.

Nurses' professional values and competency in Saudi Arabia: A structural equation modelling approach

Abstract

Aims and objectives

To explore the relationship between Saudi nurses' professional values and competence.

Background

Professionals are bound by ethical standards specific to their profession. Accordingly, the COVID-19 pandemic is the most significant event that has impacted nurses' professional values and competency.

Design

A descriptive cross-sectional design adhering to STROBE guidelines.

Methods

Clinical nurses from four tertiary government hospitals (n = 659) participated and completed two self-report instruments. Study variables were analysed using the structural equation modelling approach.

Results

The emerging model displayed acceptable model fit indices. Professionalism and activism were two dimensions of nurse professional values that significantly impacted professional competency. Professionalism significantly impacted the four other aspects of nurse professional values: caring, activism, trust, and justice. Caring had a significant and direct impact on activism. Activism had a weak, direct effect on trust, whereas justice had a moderate, direct effect on trust. Through the mediation of the dimension of activism, both the dimensions of professionalism and caring had a strong, indirect impact on professional competency.

Conclusions

This research presents a structural model of the interrelationship between nurse professional values and competency. Nurse administrators can use the proposed model to develop approaches and policies for assessing, improving and evaluating professional values among nurses.

Relevance for Clinical Practice

Nursing professionals are committed to upholding their ethical and moral standards while performing their caregiver roles. Nurse administrators can implement activities and strategies to develop nurses' professional competence further, as professional values represent the ideal values expected of nurses providing patient care.

Tailored Parenting Plans of Young Adults With Sickle Cell Disease or Sickle Cell Trait

imageOur study purpose was to evaluate the variation and accuracy of tailored parenting plans individually generated as a supplement to reproductive health education on the genetic inheritance of sickle cell disease or sickle cell trait. We present a secondary data analysis of experimental group data from a randomized controlled trial. Participants completed the valid and reliable Internet-based Sickle Cell Reproductive Health Knowledge Parenting Intent Questionnaire. We created a computerized algorithm that used participants' responses to generate tailored parenting plans based on their parenting preferences and partner's sickle cell status. Thirty-one different parenting plans were generated to meet the variety in the participants' preferences. The most frequently generated plan was for participants with sickle cell disease who had a partner with hemoglobin AA, who wanted to be a parent, was not likely to be pregnant, and wanted their child to be sickle cell disease free. More than half of the participants required alteration in their reproductive behavior to achieve their parenting goals. Findings provide insight into the variety and accuracy of computer algorithm–generated parenting plans, which could further guide refinement of the algorithm to produce patient-centered, tailored parenting plans supplemental to Internet-based genetic inheritance education.

A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers

Abstract

The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with non-healing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days(95% CI:24.3–58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device-related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non-healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.

Patients self-reported medical care for low back pain: a nationwide population-based study

Por: Gomes · L. A. · Cruz · E. B. · Henriques · A. R. · Branco · J. C. · Canhao · H. · Rodrigues · A. M.
Objectives

To estimate the prevalence of medical care-seeking among adults with low back pain (LBP) and to characterise and compare use of diagnostic procedures and medical management between primary and secondary care.

Design

Cross-sectional study.

Setting

Data from the EpiReumaPt, a nationwide population-based study conducted in Portugal including a representative sample of non-institutionalised adults (n=10 661) stratified by administrative territorial units was analysed.

Participants

Individuals who self-reported history of LBP within the previous 12 months (n=6434) and sought medical care for this problem in the same period (n=2618).

Outcome measures

Patients’ self-reported diagnostic workup and management procedures performed by medical care for LBP collected through a structured questionnaire. Medical care procedures were stratified by level of care.

Results

The prevalence of medical care-seeking for LBP was 38.0% (95% CI 35.9% to 40.1%). Primary care in isolation (45.3%) was the most sought level of care. Emergency departments (25.9%) and orthopaedics (19.4%) were the most sought secondary medical specialties. Several pathoanatomical diagnoses were used, supported by laboratory or imaging tests (91.1%). Disc herniation (20.4%) and osteoarthritis (19.7%) were the most frequent diagnoses, and X-ray (63.7%) was the most frequent diagnostic procedure self-reported by individuals. Most (75.1%) reported being treated for LBP: 80.4% with oral medication and 49.9% with injectables. The mean duration of pharmacological treatment was 104.24 (SD, 266.80) days. The use of pathoanatomical diagnoses, laboratory or imaging tests, and pharmacological treatments were generally more frequent for secondary care (p

Conclusions

Medical care for LBP is frequent and associated with high levels of pathoanatomical diagnoses, imaging and laboratory tests and pharmacological therapy in both primary and secondary care settings. Funding and delivery actions should be prioritised to assure appropriate care for LBP.

Towards definitions of critical illness and critical care using concept analysis

Por: Kayambankadzanja · R. K. · Schell · C. O. · Gerdin Wärnberg · M. · Tamras · T. · Mollazadegan · H. · Holmberg · M. · Alvesson · H. M. · Baker · T.
Objective

As ‘critical illness’ and ‘critical care’ lack consensus definitions, this study aimed to explore how the concepts’ are used, describe their defining attributes, and propose potential definitions.

Design and methods

We used the Walker and Avant approach to concept analysis. The uses and definitions of the concepts were identified through a scoping review of the literature and an online survey of 114 global clinical experts. We used the Arksey and O’Malley framework for scoping reviews and searched in PubMed and Web of Science with a strategy including terms around critical illness/care and definitions/etymologies limited to publications in English between 1 January 2008 and 1 January 2020. The experts were selected through purposive sampling and snowballing, with 36.8% in Africa, 25.4% in Europe, 22.8% in North America, 10.5% in Asia, 2.6% in South America and 1.8% in Australia. They worked with anaesthesia or intensive care 59.1%, emergency care 15.8%, medicine 9.5%, paediatrics 5.5%, surgery 4.7%, obstetrics and gynaecology 1.6% and other specialties 3.9%. Through content analysis of the data, we extracted codes, categories and themes to determine the concepts’ defining attributes and we proposed potential definitions. To assist understanding, we developed model, related and contrary cases concerning the concepts, we identified antecedents and consequences to the concepts, and defined empirical referents.

Results

Nine and 13 articles were included in the scoping reviews of critical illness and critical care, respectively. A total of 48 codes, 14 categories and 4 themes were identified in the uses and definitions of critical illness and 60 codes, 13 categories and 5 themes for critical care. The defining attributes of critical illness were a high risk of imminent death; vital organ dysfunction; requirement for care to avoid death; and potential reversibility. The defining attributes of critical care were the identification, monitoring and treatment of critical illness; vital organ support; initial and sustained care; any care of critical illness; and specialised human and physical resources. The defining attributes led to our proposed definitions of critical illness as, ‘a state of ill health with vital organ dysfunction, a high risk of imminent death if care is not provided and the potential for reversibility’, and of critical care as, ‘the identification, monitoring and treatment of patients with critical illness through the initial and sustained support of vital organ functions.’

Conclusion

The concepts critical illness and critical care lack consensus definitions and have varied uses. Through concept analysis of uses and definitions in the literature and among experts, we have identified the defining attributes of the concepts and proposed definitions that could aid clinical practice, research and policy-making.

Developing a risk stratification tool for predicting opioid-related respiratory depression after non-cardiac surgery: a retrospective study

Por: Roy · S. · Bruehl · S. · Feng · X. · Shotwell · M. S. · Van De Ven · T. · Shaw · A. D. · Kertai · M. D.
Objectives

Accurately assessing the probability of significant respiratory depression following opioid administration can potentially enhance perioperative risk assessment and pain management. We developed and validated a risk prediction tool to estimate the probability of significant respiratory depression (indexed by naloxone administration) in patients undergoing noncardiac surgery.

Design

Retrospective cohort study.

Setting

Single academic centre.

Participants

We studied n=63 084 patients (mean age 47.1±18.2 years; 50% men) who underwent emergency or elective non-cardiac surgery between 1 January 2007 and 30 October 2017.

Interventions

A derivation subsample reflecting two-thirds of available patients (n=42 082) was randomly selected for model development, and associations were identified between predictor variables and naloxone administration occurring within 5 days following surgery. The resulting probability model for predicting naloxone administration was then cross-validated in a separate validation cohort reflecting the remaining one-third of patients (n=21 002).

Results

The rate of naloxone administration was identical in the derivation (n=2720 (6.5%)) and validation (n=1360 (6.5%)) cohorts. The risk prediction model identified female sex (OR: 3.01; 95% CI: 2.73 to 3.32), high-risk surgical procedures (OR: 4.16; 95% CI: 3.78 to 4.58), history of drug abuse (OR: 1.81; 95% CI: 1.52 to 2.16) and any opioids being administered on a scheduled rather than as-needed basis (OR: 8.31; 95% CI: 7.26 to 9.51) as risk factors for naloxone administration. Advanced age (OR: 0.971; 95% CI: 0.968 to 0.973), opioids administered via patient-controlled analgesia pump (OR: 0.55; 95% CI: 0.49 to 0.62) and any scheduled non-opioids (OR: 0.63; 95% CI: 0.58 to 0.69) were associated with decreased risk of naloxone administration. An overall risk prediction model incorporating the common clinically available variables above displayed excellent discriminative ability in both the derivation and validation cohorts (c-index=0.820 and 0.814, respectively).

Conclusion

Our cross-validated clinical predictive model accurately estimates the risk of serious opioid-related respiratory depression requiring naloxone administration in postoperative patients.

Efficiency of ER:YAG laser therapy in combination with behaviour management technique in reducing anxiety among paediatric dental patients - a study protocol for a randomised clinical trial

Por: Belcheva · A. · Shindova · M.
Introduction

When providing dental care to children with a high level of dental anxiety, the range of approaches is divided into two sections: use of behaviour management techniques (BMTs) and application of alternative methods for caries removal. In an attempt to reduce dental anxiety, they can be mixed and matched in accordance with the dentists’ choice. Owing to its promoted advantages, erbium-doped yttrium aluminium garnet (Er:YAG) laser turns into an ideal alternative technique for hard dental tissue therapy in anxious paediatric patients. The aim of the study is to assess the efficacy of a modified version of the BMT ‘Latent inhibition’ in combination with Er:YAG laser for achieving a reduction of dental anxiety in paediatric dental patients.

Methods and analysis

This is a protocol for a randomised controlled clinical trial. The participants will be children aged 6–9 years, requiring conservative treatment of occlusal carious lesion on a second primary molar. Patients will be randomly assigned to the experimental or control group via a computer-generated sequence. In both groups, ‘Latent inhibition’ will be used as an anxiety-management technique. In the experimental group, caries treatment will be performed with Er:YAG laser, whereas that in the control group it will be performed with conventional rotary instruments. Outcome measures will be dental anxiety felt before and after the treatment, reported by the patient on a modified version of the Faces Scale by LeBaron et al., and the dynamics of heart rate, registered during the treatment session, which will be measured with a mobile pulse oximeter. Data will be analysed by independent sample t-test and paired t-test (p0.05).

Ethics and dissemination

The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University–Plovdiv, Bulgaria (reference number P-2839, protocol of approval number 3/30.04.2015) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations.

Trial registration number

NCT04924452.

What can lead to late diagnosis of HIV in an illegal gold mining environment? A qualitative study at the French Guianas border with Brazil

Por: Floersheim · C. · Musso · S. · Eubanks · A. · Douine · M. · Spire · B. · Sagaon-Teyssier · L. · Parriault · M. C. · Girard · G. · Mosnier · E.
Objective

The present study aimed to understand what factors can lead to late HIV diagnosis of illegal gold miners at French Guiana’s border with Brazil.

Design

An exploratory qualitative study with in-depth interviews and observations was conducted between November 2019 and February 2020.

Setting

The study was conducted in the main medical healthcare service and two non-governmental organisation premises in the Oyapock border region, which is a supply area for illegal gold mining sites.

Participants

Fifteen people living with HIV diagnosed with CD4 count 6/L were interviewed. Seven women and eight men participated; they were between 31 and 79 years old, and the median time since HIV diagnosis was 6 years. Eight had links to illegal gold mining.

Findings

Three key themes for late HIV diagnosis emerged: (1) the presence of economic and political structural factors which constitute risks for this illegal activity, specifically the repression of gold mining sites by French Armed Forces and the distance from healthcare facilities; (2) representations of the body and health, related to the living conditions of this population; prioritisation of health emergencies and long-term self-medication; and (3) gender roles shaping masculinity and heterosexuality contributing to a perception of not being at risk of HIV and delaying testing.

Conclusion

This study highlights structural, group-based and individual factors that reduce access to HIV testing and healthcare in general for a population of migrant workers in an illegal gold mining area. Faced with harsh living conditions and state repression, these workers develop a vision of health which prioritises the functionality of the body. Associated with gender roles which are partly shaped both by the mining activity and its geographical location, this vision can lead to late HIV diagnosis.

Rural-urban differentials in the influences of individual and geospatial preparedness on institutional childbirth: a cross-sectional study in Bangladesh

Por: Rahman · M. M. · Ara · T. · Aninda · M. H. H. M. K. · Nurul · A. · Haider · M. M.
Objective

This study aims to explore the rural–urban differentials in the influences of individual and geospatial preparedness on institutional childbirth in Bangladesh. A related aim of this paper is to derive estimates to measure geospatial preparedness for institutional births, through statistical modelling, when no data are available for measuring this areal indicator.

Design, settings and participants

The paper used data from a large-scale nationally representative Bangladesh Multiple Indicator Cluster Survey 2019. The analytical sample included 9203 currently married women of reproductive age who had a live birth in the 2 years preceding the survey.

Methods

Mixed effect logistic regression models were employed to explore the rural–urban differentials in influences of individual and geospatial preparedness on institutional childbirth. The district-level random effect estimation was done to measure geospatial preparedness. The conditional autoregressive model was used to examine the association of geospatial preparedness with areal variation in institutional births.

Results

In rural settings, women who gave birth to a female newborn were 18% less likely to have facility births compared with women who gave birth to a male newborn. Also, women from households in the highest wealth quintile were twice as likely to have facility births compared with those from households in the poorest wealth quintile. In contrast, in urban areas, facility births did not vary by sex of the fetus or by households’ socioeconomic status. The geospatial preparedness explained 8% and 9% of the variability in institutional births in rural and urban areas, respectively. Geospatial mapping revealed low preparedness in the hill tracts. Findings identified geospatial preparedness as a potential source of areal variation in facility births.

Conclusion

Findings suggest improving district-level preparedness and developing differential programme strategies for urban and rural areas to increase the national prevalence and more equitable use of institutional childbirth in Bangladesh.

Multicountry study protocol of COCOON: COntinuing Care in COVID-19 Outbreak global survey of New, expectant, and bereaved parent experiences

Por: Loughnan · S. A. · Gautam · R. · Silverio · S. A. · Boyle · F. M. · Cassidy · J. · Ellwood · D. · Homer · C. · Horey · D. · Leisher · S. H. · de Montigny · F. · Murphy · M. · O'Donoghue · K. · Quigley · P. · Ravaldi · C. · Sandall · J. · Storey · C. · Vannacci · A. · Wilson · A. N. · Flena
Introduction

Globally, the COVID-19 pandemic has significantly disrupted the provision of healthcare and efficiency of healthcare systems and is likely to have profound implications for pregnant and postpartum women and their families including those who experience the tragedy of stillbirth or neonatal death. This study aims to understand the psychosocial impact of COVID-19 and the experiences of parents who have accessed maternity, neonatal and bereavement care services during this time.

Methods and analysis

An international, cross-sectional, online and/or telephone-based/face-to-face survey is being administered across 15 countries and available in 11 languages. New, expectant and bereaved parents during the COVID-19 pandemic will be recruited. Validated psychometric scales will be used to measure psychosocial well-being. Data will be analysed descriptively and by assessing multivariable associations of the outcomes with explanatory factors. In seven of these countries, bereaved parents will be recruited to a nested, qualitative interview study. The data will be analysed using a grounded theory analysis (for each country) and thematic framework analysis (for intercountry comparison) to gain further insights into their experiences.

Ethics and dissemination

Ethics approval for the multicountry online survey, COCOON, has been granted by the Mater Misericordiae Human Research Ethics Committee in Australia (reference number: AM/MML/63526). Ethics approval for the nested qualitative interview study, PUDDLES, has been granted by the King’s College London Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee (reference number: HR-19/20-19455) in the UK. Local ethics committee approvals were granted in participating countries where required. Results of the study will be published in international peer-reviewed journals and through parent support organisations. Findings will contribute to our understanding of delivering maternity care services, particularly bereavement care, in high-income, lower middle-income and low-income countries during this or future health crises.

Sleep quality and associated factors among pregnant women attending antenatal care unit at Gondar, Ethiopia: a cross-sectional study

Por: Takelle · G. M. · Muluneh · N. Y. · Biresaw · M. S.
Objective

This study aimed to determine the prevalence and associated factors of poor sleep quality among pregnant women in Ethiopia.

Method

Institutional based cross-sectional study.

Setting

University of Gondar Comprehensive Specialized Hospital, Gondar, Ethiopia.

Participants

A total of 415 pregnant women were recruited by using a systematic random sampling technique from 28 April 2020 to 12 June 2020.

Measurement

The desired data were collected through face-to-face interview technique by using validated questionnaires such as the Pittsburgh Sleep Quality Index, Edinburgh Postnatal Depression Scale, Perceived Stress Scale, Oslo-3 and Abuse Assessment Screen. The data were analysed by using SPSS V.20. Logistic regression analysis was used to identify associated factors with poor sleep quality. Variables having a p value of less than 0.2 in the bivariate analysis were entered to the multivariable logistic regression. A p value of less than 0.05 was considered statistically significant, at 95% CI.

Result

In this study, 175 (42.2%) pregnant women had poor sleep quality. According to multivariable logistic regression, being first and third trimesters of gestational age (adjusted OR (aOR) 2.31, 95% CI 1.16 to 4.61 and aOR 3.45, 95% CI 2.05 to 5.79, respectively), consumption of caffeinated substances (aOR 2.96, 95% CI 1.68 to 5.52), having depression (aOR 2.12, 95% CI 1.19 to 3.76), having high perceived stress (aOR 5.39, 95% CI 1.96 to 14.79) and experience of intimate partner violence (aOR 5.57, 95% CI 2.19 to 14.68) were positive significant associated factors with poor sleep quality.

Conclusion and recommendation

The prevalence of poor sleep quality among pregnant women was relatively high. First and third trimesters, consumption of caffeinated substances, antenatal depression, high perceived stress and intimate partner violence were factors significantly associated with poor sleep quality. This result suggests that all pregnant women should be screened and treated for poor sleep quality during the first and third trimesters.

Quality of reporting of randomised controlled trials of artificial intelligence in healthcare: a systematic review

Por: Shahzad · R. · Ayub · B. · Siddiqui · M. A. R.
Objectives

The aim of this study was to evaluate the quality of reporting of randomised controlled trials (RCTs) of artificial intelligence (AI) in healthcare against Consolidated Standards of Reporting Trials—AI (CONSORT-AI) guidelines.

Design

Systematic review.

Data sources

We searched PubMed and EMBASE databases for studies reported from January 2015 to December 2021.

Eligibility criteria

We included RCTs reported in English that used AI as the intervention. Protocols, conference abstracts, studies on robotics and studies related to medical education were excluded.

Data extraction

The included studies were graded using the CONSORT-AI checklist, comprising 43 items, by two independent graders. The results were tabulated and descriptive statistics were reported.

Results

We screened 1501 potential abstracts, of which 112 full-text articles were reviewed for eligibility. A total of 42 studies were included. The number of participants ranged from 22 to 2352. Only two items of the CONSORT-AI items were fully reported in all studies. Five items were not applicable in more than 85% of the studies. Nineteen per cent (8/42) of the studies did not report more than 50% (21/43) of the CONSORT-AI checklist items.

Conclusions

The quality of reporting of RCTs in AI is suboptimal. As reporting is variable in existing RCTs, caution should be exercised in interpreting the findings of some studies.

What are common barriers and helpful solutions to colorectal cancer screening? A cross-sectional survey to develop intervention content for a planning support tool

Por: Kotzur · M. · Macdonald · S. · O'Carroll · R. E. · O'Connor · R. C. · Irvine · A. · Steele · R. J. C. · Robb · K. A.
Objective

Colorectal screening using faecal immunochemical tests (FITs) can save lives if the people invited participate. In Scotland, most people intend to complete a FIT but this is not reflected in uptake rates. Planning interventions can bridge this intention-behaviour gap. To develop a tool supporting people willing to do colorectal screening with planning to complete a FIT, this study aimed to identify frequently experienced barriers and solutions to these barriers.

Design

This is a cross-sectional study.

Setting

Participants were recruited through the Scottish Bowel Screening Programme to complete a mailed questionnaire.

Participants

The study included 2387 participants who had completed a FIT (mean age 65 years, 40% female) and 359 participants who had not completed a FIT but were inclined to do so (mean age 63 years, 39% female).

Outcome measures

The questionnaire assessed frequency of endorsement of colorectal screening barriers and solutions.

Results

Participants who had not completed a FIT endorsed significantly more barriers than those who had completed a FIT, when demographic, health and behavioural covariates were held constant (F(1,2053)=13.40, p2=0.01). Participants who completed a FIT endorsed significantly more solutions than those who did not (U=301 585.50, z=–3.21, p

Conclusion

This survey identified six barriers and seven solutions as key content to include in the development of a planning tool for colorectal screening using the FIT. Participatory research is required to codesign an engaging and accessible planning tool.

Development and validation of a dynamic 48-hour in-hospital mortality risk stratification for COVID-19 in a UK teaching hospital: a retrospective cohort study

Por: Wiegand · M. · Cowan · S. L. · Waddington · C. S. · Halsall · D. J. · Keevil · V. L. · Tom · B. D. M. · Taylor · V. · Gkrania-Klotsas · E. · Preller · J. · Goudie · R. J. B.
Objectives

To develop a disease stratification model for COVID-19 that updates according to changes in a patient’s condition while in hospital to facilitate patient management and resource allocation.

Design

In this retrospective cohort study, we adopted a landmarking approach to dynamic prediction of all-cause in-hospital mortality over the next 48 hours. We accounted for informative predictor missingness and selected predictors using penalised regression.

Setting

All data used in this study were obtained from a single UK teaching hospital.

Participants

We developed the model using 473 consecutive patients with COVID-19 presenting to a UK hospital between 1 March 2020 and 12 September 2020; and temporally validated using data on 1119 patients presenting between 13 September 2020 and 17 March 2021.

Primary and secondary outcome measures

The primary outcome is all-cause in-hospital mortality within 48 hours of the prediction time. We accounted for the competing risks of discharge from hospital alive and transfer to a tertiary intensive care unit for extracorporeal membrane oxygenation.

Results

Our final model includes age, Clinical Frailty Scale score, heart rate, respiratory rate, oxygen saturation/fractional inspired oxygen ratio, white cell count, presence of acidosis (pH

Conclusions

Our model incorporates both static risk factors (eg, age) and evolving clinical and laboratory data, to provide a dynamic risk prediction model that adapts to both sudden and gradual changes in an individual patient’s clinical condition. On successful external validation, the model has the potential to be a powerful clinical risk assessment tool.

Trial registration

The study is registered as ‘researchregistry5464’ on the Research Registry (www.researchregistry.com).

Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial

Por: Peiris · R. G. · Ross · H. · Chan · C. T. · Poon · S. · Auguste · B. L. · Rac · V. E. · Farkouh · M. · McDonald · M. · Kaczorowski · J. · Code · J. · Duero Posada · J. · Ong · S. · Kobulnik · J. · Tomlinson · G. · Huszti · E. · Arcand · J. · Thomas · S. G. · Akbari · A. · Maunder · R. · Grov
Introduction

Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE–vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self–care materials, and health-related quality of life.

Methods and analysis

Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes.

Ethics and dissemination

The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care.

Trial registration number

NCT04966104

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