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Usability Experience of a Personal Sleep Monitoring Device to Self-manage Sleep Among Persons 65 Years or Older With Self-reported Sleep Disturbances

imageIncreasingly, persons with self-reported health symptoms are using mobile health technologies to better understand, validate, and manage their symptoms. These off-the-shelf devices primarily utilize actigraphy to estimate sleep and activity. The purpose of this study was to describe qualitatively the experience of using a personal sleep monitoring device for sleep self-management in adults 65 years or older with self-reported sleep disturbances. This study followed a hybrid qualitative design using deductive and emergent coding derived from open-ended interviews (n = 25) after a period of 4 weeks using a wearable personal sleep monitoring device. Results expanded existing theoretical models on usability with the theme of personal meaning in the interaction between health and self-monitoring technology that were associated with age and technology use, privacy, and capability. Future studies for sleep health self-management and personally tailored interventions using personal sleep monitoring devices should continue to collect qualitative information in extending the understanding of user experience across different symptom clusters, such as sleep disturbances, that manifest more commonly in older age populations. This research is important for application in the use of mobile health technologies for nursing led health self-management interventions.

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.

Coping in the role as next of kin of a person with a brain tumour: a qualitative metasynthesis

Por: Lien · A. W. · Rohde · G.
Objective

Being the next of kin of a person with a brain tumour is a stressful experience. For many, being a next of kin involves fear, insecurity and overwhelming responsibility. The purpose of this study was to identify and synthesise qualitative original studies that explore coping in the role as next of kin of a person with a brain tumour.

Methods

A qualitative metasynthesis guided by Sandelowski and Barroso’s guidelines was used. The databases Medline, CHINAL and PsycINFO were searched for studies from January 2000 to 18 January 2022. Inclusion criteria were qualitative original studies that aimed to explore coping experience by the next of kin of a person with brain tumour. The next of kin had to be 18 years of age or older.

Results

Of a total of 1476 screened records data from 20 studies, including 342 participants (207 females, 81 males and 54 unclassified) were analysed into metasummaries and a metasynthesis. The metasynthesis revealed that the next of kin coping experiences were characterised by two main themes: (1) coping factors within the next of kin and as a support system, such as their personal characteristics, perceiving the role as meaningful, having a support system, and hope and religion; (2) coping strategies—control and proactivity, including regaining control, being proactive and acceptance.

Conclusion

Next of kin of patients with brain tumours used coping factors and coping strategies gathered within themselves and in their surroundings to handle the situation and their role. It is important that healthcare professionals suggest and facilitate these coping factors and strategies because this may reduce stress and make the role of next of kin more manageable.

Prevalence and predictors of mother and newborn skin-to-skin contact at birth in Papua New Guinea

Por: Aboagye · R. G. · Okyere · J. · Dowou · R. K. · Adzigbli · L. A. · Tackie · V. · Ahinkorah · B. O. · Seidu · A.-A.
Objective

This study examined the prevalence and predictors of maternal and newborn skin-to-skin contact at birth in Papua New Guinea.

Design

Data for the study was extracted from the 2016–18 Papua New Guinea Demographic and Health Survey. We included 6,044 women with birth history before the survey in the analysis. Percentages were used to summarise the prevalence of maternal and newborn skin-to-skin contact. A multivariable multilevel binary logistic regression was adopted to examine the predictors of maternal and newborn skin-to-skin contact. The results were presented using adjusted ORs (aORs), with their respective 95% confidence intervals (CIs). Statistical significance was set at p

Setting

The study was conducted in Papua New Guinea.

Participant

Mothers with children under 5 years.

Outcome measures

Mother and newborn skin-to-skin contact.

Results

The prevalence of mother and newborn skin-to-skin contact was 45.2% (95% CI=42.4 to 48.0). The odds of mother and newborn skin-to-skin contact was higher among women with primary education (aOR=1.38; 95% CI=1.03 to 1.83), women with four or more antenatal care attendance (aOR=1.27; 95% CI=1.01 to 1.61), those who delivered at the health facility (aOR=1.27; 95% CI=1.01 to 1.61), and women from communities with high socioeconomic status (aOR=1.45; 95% CI=1.11 to 1.90).

Conclusion

The study has demonstrated that the prevalence of mother and newborn skin-to-skin contact in Papua New Guinea is low. Factors shown to be associated with mother and newborn skin-to-skin contact were maternal level of education, antenatal care attendance, health facility delivery, and community socioeconomic status. A concerted effort should be placed in improving maternal health service utilisation such as antenatal care attendance and skilled birth delivery, which subsequently lead to the practice of skin-to-skin contact. Also, women should be empowered through education as it has positive impact on their socioeconomic status and health service utilisation.

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.

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.

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

Intraurban socioeconomic inequalities in life expectancy: a population-based cross-sectional analysis in the city of Cordoba, Argentina (2015-2018)

Por: Rodriguez Lopez · S. · Tumas · N. · Bilal · U. · Moore · K. A. · Acharya · B. · Quick · H. · Quistberg · D. A. · Acevedo · G. E. · Diez Roux · A. V.
Objectives

To evaluate variability in life expectancy at birth in small areas, describe the spatial pattern of life expectancy, and examine associations between small-area socioeconomic characteristics and life expectancy in a mid-sized city of a middle-income country.

Design

Cross-sectional, using data from death registries (2015–2018) and socioeconomic characteristics data from the 2010 national population census.

Participants/setting

40 898 death records in 99 small areas of the city of Córdoba, Argentina. We summarised variability in life expectancy at birth by using the difference between the 90th and 10th percentile of the distribution of life expectancy across small areas (P90-P10 gap) and evaluated associations with small-area socioeconomic characteristics by calculating a Slope Index of Inequality in linear regression.

Primary outcome

Life expectancy at birth.

Results

The median life expectancy at birth was 80.3 years in women (P90-P10 gap=3.2 years) and 75.1 years in men (P90-P10 gap=4.6 years). We found higher life expectancies in the core and northwest parts of the city, especially among women. We found positive associations between life expectancy and better small-area socioeconomic characteristics, especially among men. Mean differences in life expectancy between the highest versus the lowest decile of area characteristics in men (women) were 3.03 (2.58), 3.52 (2.56) and 2.97 (2.31) years for % adults with high school education or above, % persons aged 15–17 attending school, and % households with water inside the dwelling, respectively. Lower values of % overcrowded households and unemployment rate were associated with longer life expectancy: mean differences comparing the lowest versus the highest decile were 3.03 and 2.73 in men and 2.57 and 2.34 years in women, respectively.

Conclusion

Life expectancy is substantially heterogeneous and patterned by socioeconomic characteristics in a mid-sized city of a middle-income country, suggesting that small-area inequities in life expectancy are not limited to large cities or high-income countries.

Systematic scoping review on moral distress among physicians

Por: Quek · C. W. N. · Ong · R. R. S. · Wong · R. S. M. · Chan · S. W. K. · Chok · A. K.-L. · Shen · G. S. · Teo · A. Y. T. · Panda · A. · Burla · N. · Wong · Y. A. · Chee · R. C. H. · Loh · C. Y. L. · Lee · K. W. · Tan · G. H. N. · Leong · R. E. J. · Koh · N. S. Y. · Ong · Y. T. · Chin · A. M
Background

Concepts of moral distress (MD) among physicians have evolved and extend beyond the notion of psychological distress caused by being in a situation in which one is constrained from acting on what one knows to be right. With many accounts involving complex personal, professional, legal, ethical and moral issues, we propose a review of current understanding of MD among physicians.

Methods

A systematic evidence-based approach guided systematic scoping review is proposed to map the current concepts of MD among physicians published in PubMed, Embase, PsycINFO, Web of Science, SCOPUS, ERIC and Google Scholar databases. Concurrent and independent thematic and direct content analysis (split approach) was conducted on included articles to enhance the reliability and transparency of the process. The themes and categories identified were combined using the jigsaw perspective to create domains that form the framework of the discussion that follows.

Results

A total of 30 156 abstracts were identified, 2473 full-text articles were reviewed and 128 articles were included. The five domains identified were as follows: (1) current concepts, (2) risk factors, (3) impact, (4) tools and (5) interventions.

Conclusions

Initial reviews suggest that MD involves conflicts within a physician’s personal beliefs, values and principles (personal constructs) caused by personal, ethical, moral, contextual, professional and sociocultural factors. How these experiences are processed and reflected on and then integrated into the physician’s personal constructs impacts their self-concepts of personhood and identity and can result in MD. The ring theory of personhood facilitates an appreciation of how new experiences create dissonance and resonance within personal constructs. These insights allow the forwarding of a new broader concept of MD and a personalised approach to assessing and treating MD. While further studies are required to test these findings, they offer a personalised means of supporting a physician’s MD and preventing burn-out.

Satisfaction and its determinants of rural upper gastrointestinal cancer screening in China: a preliminary cross-sectional study

Por: Feng · X. · Zhu · J.-H. · Hua · Z.-L. · Xu · X. · Li · Y. · Li · J. · Song · G.-H. · Wang · X. · Su · M. · Zhou · J.-Y.
Objectives

To assess participants’ satisfaction with and predictors of upper gastrointestinal cancer screening in rural areas.

Design

Cross-sectional study.

Setting

Ten screening centres in seven cities across five provinces in China.

Participants

Of the 452 participants screened during the survey period, 438 completed the survey (response rate: 96.90%).

Primary outcome measures

Screening satisfaction was the primary outcome and it was assessed using the Patient Satisfaction Questionnaire-18. Ordinal logistic regression analysis was used to analyse the predictors of satisfaction.

Results

The percentages of satisfaction with the General Satisfaction, Technical Quality, Interpersonal Manner, Communication, Financial Aspects, Time Spent With Doctor, and Convenience and Accessibility dimensions were 95.89%, 79.68%, 88.36%, 83.56%, 75.11%, 82.19% and 66.44%, respectively. Education (OR 0.25, 95% CI 0.07 to 0.90), health self-assessment (OR 15.29, 95% CI 2.86 to 81.78) and family history of cancer (OR 4.20, 95% CI 1.29 to 13.71) were associated with General Satisfaction. Residence (OR 4.31, 95% CI 1.89 to 9.81) was associated with Technical Quality. Occupation (OR 0.27, 95% CI 0.08 to 0.88), health self-assessment (OR 11.30, 95% CI 3.94 to 32.43), screening purpose (OR 0.18, 95% CI 0.03 to 0.92) and distance from the screening centre (OR 4.59, 95% CI 1.35 to 15.61) were associated with interpersonal manner. Gender (OR 1.85, 95% CI 1.02 to 3.34), residence (OR 3.23, 95% CI 1.23 to 8.53) and endoscopy in the previous year (OR 2.79, 95% CI 1.13 to 6.90) were associated with Communication. Body mass index (BMI; OR 5.06, 95% CI 1.40 to 18.25) and health self-assessment (OR 2.09, 95% CI 1.12 to 3.88) were associated with financial aspects. Gender (OR 1.90, 95% CI 1.07 to 3.38), residence (OR 3.19, 95% CI 1.30 to 7.79), BMI (OR 5.26, 95% CI 1.14 to 24.34) and health self-assessment (OR 2.14, 95% CI 1.06 to 4.34) were associated with time spent with doctor. Gender (OR 1.64, 95% CI 1.04 to 2.60) and residence (OR 3.17, 95% CI 1.46 to 6.88) were associated with convenience and accessibility.

Conclusion

There was heterogeneity across the dimensions of satisfaction with rural upper gastrointestinal cancer screening. Project manager should prioritise improving the aspects related to the convenience and accessibility dimension. Furthermore, to improve the efficiency of potential interventions, the predictors of the various dimensions should be considered.

Evaluating effects of the structural reform of outpatient psychotherapy for patients with mental disorders in Germany: comparing patients with and without comorbid chronic physical condition - rationale and study protocol of the ES-RiP project

Por: Kampling · H. · Kruse · J. · Friederich · H.-C. · Heuft · G. · Christoffer · A. · Grobe · T. G. · Marschall · U. · Szecsenyi · J. · Wild · B. · Hartmann · M. · The ES-RiP-Consortium Study Group · Borchers · Christoffer · Soufiane · Friederich · Thomas G · Hartmann · Hegelow · Heuft
Introduction

In 2017, in Germany, a structural reform of the outpatient psychotherapy guideline took place, aiming to reduce waiting times, to facilitate flexible low-threshold access (eg, general reachability by phone) and to lower access barriers for specific patient groups. The reform included new service elements, such as the implementation of additional psychotherapeutic consultations, acute short-term psychotherapeutic interventions and relapse prophylaxis as well as the promotion of group therapies, the facilitation of psychotherapists’ availability, and the installation of appointment service centres. The ES-RiP project aims to thoroughly evaluate the effects of the reform with a special focus on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs) compared with patients with a mental disorder but no long-term physical condition (MnoP). The project aims to evaluate (a) the extent to which the reform goals were achieved in the large group of patients with cMPs compared with MnoP, (b) the barriers that might hinder the implementation of the new guideline and (c) the procedures required for further developing and improving outpatient psychotherapy.

Methods and analysis

A mixed-methods design (quantitative, qualitative) along with a multilevel approach (patients, service providers, payers) triangulating several data sources (primary and secondary data) will be applied to evaluate the reform from different perspectives.

Ethics and dissemination

Ethical approval was obtained from the coordinating committee as well as one local ethics committee, Justus Liebig University Giessen and Marburg – Faculty of Medicine (approval number: AZ 107/20) and Heidelberg (approval number: S-466/2020). The results of this study will be disseminated through expert panels, conference presentations and publications in peer-reviewed journals.

Trial registration number

DRKS00020344.

Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper

Por: Jobson · D. · Roffey · B. · Best · R. · Button-Sloan · A. · Cossio · D. · Evans · S. · Shang · C. · Moore · J. · Arnold · C. · Mann · G. · Shackleton · M. · Soyer · H. P. · Morton · R. L. · Zalcberg · J. · Mar · V.
Introduction

Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers.

Methods and analysis

A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians.

Ethics and dissemination

Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20).

Development of a screening tool for the need of specialist palliative care in oncologic inpatients: study protocol for the ScreeningPALL Study

Por: Müller · E. · Müller · M. J. · Boehlke · C. · Ramsenthaler · C. · Jäger · H. · Schäfer · H. · Ostgathe · C. · Klein · C. · Simon · S. · Becker · G.
Introduction

A range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II).

Methods and analysis

Inclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss’ Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need.

Ethics and dissemination

Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs—University Freiburg, Germany (approval no. 20-1103).

Trial registration number

German Clinical Trials Register, DRKS00021686, registered on 17 December 2020.

Association of intranasal esketamine, a novel 'standard of care treatment and outcomes in the management of patients with treatment-resistant depression: protocol of a prospective cohort observational study of naturalistic clinical practice

Por: Vazquez · G. · Gutierrez · G. · Rosenblat · J. · Schaffer · A. · Swainson · J. · Karthikeyan · G. · Ravindran · N. · Lam · R. W. · Do · A. · Giacobbe · P. · Hawken · E. · Milev · R.
Introduction

Esketamine is the S-enantiomer of racemic ketamine and has been approved by the Food and Drug Administration for the management of treatment resistant depression, demonstrating effective and long-lasting benefits. The objective of this observational study is to elucidate the association of intranasal (IN) esketamine with beneficial and negative outcomes in the management of treatment resistant major depressive disorder.

Methods and analysis

This is a multicentre prospective cohort observational study of naturalistic clinical practice. We expect to recruit 10 patients per research centre (6 centres, total 60 subjects). After approval to receive IN esketamine as part of their standard of care management of moderate to severe treatment resistant depression, patients will be invited to participate in this study. Association of esketamine treatment with outcomes in the management of depression will be assessed by measuring the severity of depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS), and tolerability by systematically tracking common side effects of ketamine treatment, dissociation using the simplified 6-Item Clinician Administered Dissociative Symptom Scale and potential for abuse using the Likeability and Craving Questionnaire (LCQ). Change in depressive symptoms (MADRS total scores) over time will be evaluated by within-subject repeated measures analysis of variance. We will calculate the relative risk associated with the beneficial (reduction in total scores for depression) outcomes, and the side effect and dropout rates (tolerability) of adding IN esketamine to patients’ current pharmacological treatments. Covariate analysis will assess the impact of site and demographic variables on treatment outcomes.

Ethics and dissemination

Approval to perform this study was obtained through the Health Sciences Research Ethics Board at Queen’s University. Findings will be shared among collaborators, through departmental meetings, presented on different academic venues and publishing our manuscript.

Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial

Por: Romero · S. A. D. · Emard · N. · Baser · R. E. · Panageas · K. · MacLeod · J. · Walker · D. · Barton-Burke · M. · Liou · K. · Deng · G. · Farrar · J. · Xiao · H. · Mao · J. J. · Epstein · A.
Introduction

Pain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.

Methods and analysis

We describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.

Ethics and dissemination

The Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.

Trial registration number

NCT04095234.

Soluble CD146 in the detection and grading of intravascular and tissue congestion in patients with acute dyspnoea: analysis of the prospective observational Lithuanian Echocardiography Study of Dyspnoea in Acute Settings (LEDA) cohort

Por: Jukneviciene · R. · Simonavicius · J. · Mikalauskas · A. · Cerlinskaite-Bajore · K. · Arrigo · M. · Juknevicius · V. · Alitoit-Marrote · I. · Kablucko · D. · Bagdonaite · L. · Vitkus · D. · Balciunas · M. · Zuoziene · G. · Barysiene · J. · Zaliaduonyte · D. · Stasaitis · K. · Kavoliu
Objectives

To evaluate the potential of soluble cluster of differentiation 146 (sCD146) in the detection and grading of congestion in patients with acute dyspnoea.

Design

Subanalysis of the prospective observational Lithuanian Echocardiography Study of Dyspnoea in Acute Settings (LEDA) cohort.

Setting

Two Lithuanian university centres.

Participants

Adult patients with acute dyspnoea admitted to the emergency department.

Methods

Congestion was assessed using clinical and sonographic parameters. All patients underwent sCD146 and N-terminal pro-B-type natriuretic peptide (NT-proBNP) testing.

Results

The median value of sCD146 concentration in the study cohort (n=437) was 405 (IQR 315–509) ng/mL. sCD146 was higher in patients with peripheral oedema than in those without (median (IQR) 472 (373–535) vs 400 (304–501) ng/mL, p=0.009) and with pulmonary rales than in those without (439 (335–528) vs 394 (296–484) ng/mL, p=0.001). We found a parallel increase of estimated right atrial pressure (eRAP) and sCD146 concentration: sCD146 was 337 (300–425), 404 (290–489) and 477 (363–572) ng/mL in patients with normal, moderately elevated and high eRAP, respectively (p=0.001). In patients with low NT-proBNP, high sCD146 distinguished a subgroup with a higher prevalence of oedema as compared with patients with low levels of both biomarkers (76.0% vs 41.0%, p=0.010). Moreover, high sCD146 indicated a higher prevalence of elevated eRAP, irrespective of NT-proBNP concentration (p

Conclusion

sCD146 concentration reflects the degree of intravascular and tissue congestion assessed by clinical and echocardiographic indices, with this association maintained in patients with low NT-proBNP. Our data support the notion that NT-proBNP might represent heart stretch while sCD146 rather represents peripheral venous congestion.

Treatment patterns for oral anticoagulants in older patients with atrial fibrillation: a retrospective, cross-sectional, nationwide study from Denmark

Por: Rasmussen · P. V. · Sakthivel · T. · Dalgaard · F. · Gislason · G. H. · Pallisgaard · J. L. · Hansen · M. L.
Objectives

Atrial fibrillation (AF) is a predominant risk factor of ischaemic stroke and treatment with oral anticoagulants (OACs) is recommended in all patients with risk factors. This study sought to examine treatment patterns of OACs in older patients with AF.

Design

Retrospective, cross-sectional study.

Setting

Danish nationwide administrative and clinical registers and databases.

Participants

A total of 40 027 patients, >75 years of age, after their first hospital contact due to AF between 2010 and 2018.

Primary and secondary outcomes measures

The primary event of interest was claimed prescriptions for OACs within 180 days after first hospital contact due to AF. Proportions of patients treated with OACs were estimated and clinical factors associated with the probability of receiving OAC treatment were identified using adjusted logistic regression models.

Results

A total of 40 027 patients were included with a slight majority of women (54%). The median age was 81 years (IQR 78–86). We found that an overall 32 235 patients (81%) were prescribed an OAC after their first hospital contact due to AF with a marked increase in the proportion of patients treated from 2010 to 2018. Factors related to a decreased probability of receiving treatment were bleeding risk factors such as a history of haemorrhagic stroke (OR 0.21, 95% CI 0.16 to 0.27), any bleeding (OR 0.58, 95% CI 0.53 to 0.62) as well as markers of frailty such as osteoporosis (OR 0.78, 95% CI 0.71 to 0.85).

Conclusion

In this large nationwide study, we found that in older patients with AF, the overall rates of OAC prescription were generally high (~80%) and increasing during the last decade. Factors associated with not receiving guideline recommended OAC treatment were generally related to bleeding risk factors or frailty.

Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial

Por: Steiness · J. · Hägi-Pedersen · D. · Lunn · T. H. · Lindberg-Larsen · M. · Graungaard · B. K. · Lundstrom · L. H. · Lindholm · P. · Brorson · S. · Bieder · M. J. · Beck · T. · Skettrup · M. · von Cappeln · A. G. · Thybo · K. H. · Gasbjerg · K. S. · Overgaard · S. · Jakobsen · J. C.
Introduction

Multimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of different combinations of paracetamol, ibuprofen and dexamethasone following total hip arthroplasty.

Methods and analysis

RECIPE is a randomised, placebo-controlled, parallel 4-group, blinded trial with 90-day and 1-year follow-up performed at nine Danish hospitals. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Eligible participants undergoing total hip arthroplasty are randomised to:group A: oral paracetamol 1000 mg x 4+oral ibuprofen 400 mg x 4+intravenous placebo; group B: oral paracetamol 1000 mg x 4+intravenous dexamethasone 24 mg+oral placebo; group C: oral ibuprofen 400 mg x 4+intravenous dexamethasone 24 mg+oral placebo; group D: oral paracetamol 1000 mg x 4+oral ibuprofen 400 mg x 4+intravenous dexamethasone 24 mg.

Primary outcome is cumulative opioid consumption at 0–24 hours. Secondary outcomes are pain at rest, during mobilisation and during a 5 m walk and adverse events. Follow-up includes serious adverse events and patient reported outcome measures at 90 days and 1 year. A total of 1060 participants are needed to demonstrate a difference of 8 mg in 24-hour morphine consumption assuming an SD of 24.5 mg, a risk of type I errors of 0.0083 and a risk of type 2 errors of 0.2. Primary analysis will be a modified intention-to-treat analysis.

With this trial we aim to verify recommendations for pain treatment after total hip arthroplasty, and investigate the role of dexamethasone as an analgesic adjuvant to paracetamol and ibuprofen.

Ethics and dissemination

This trial is approved by the Region Zealand Committee on Health Research Ethics (SJ-799). Plans for dissemination include publication in peer-reviewed journals and presentation at scientific meetings.

Trial registration number

NCT04123873.

Dynamic accessibility by car to tertiary care emergency services in Cali, Colombia, in 2020: cross-sectional equity analyses using travel time big data from a Google API

Objectives

To test a new approach to characterise accessibility to tertiary care emergency health services in urban Cali and assess the links between accessibility and sociodemographic factors relevant to health equity.

Design

The impact of traffic congestion on accessibility to tertiary care emergency departments was studied with an equity perspective, using a web-based digital platform that integrated publicly available digital data, including sociodemographic characteristics of the population and places of residence with travel times.

Setting and participants

Cali, Colombia (population 2.258 million in 2020) using geographic and sociodemographic data. The study used predicted travel times downloaded for a week in July 2020 and a week in November 2020.

Primary and secondary outcomes

The share of the population within a 15 min journey by car from the place of residence to the tertiary care emergency department with the shortest journey (ie, 15 min accessibility rate (15mAR)) at peak-traffic congestion hours. Sociodemographic characteristics were disaggregated for equity analyses. A time-series bivariate analysis explored accessibility rates versus housing stratification.

Results

Traffic congestion sharply reduces accessibility to tertiary emergency care (eg, 15mAR was 36.8% during peak-traffic hours vs 84.4% during free-flow hours for the week of 6–12 July 2020). Traffic congestion sharply reduces accessibility to tertiary emergency care. The greatest impact fell on specific ethnic groups, people with less educational attainment and those living in low-income households or on the periphery of Cali (15mAR: 8.1% peak traffic vs 51% free-flow traffic). These populations face longer average travel times to health services than the average population.

Conclusions

These findings suggest that health services and land use planning should prioritise travel times over travel distance and integrate them into urban planning. Existing technology and data can reveal inequities by integrating sociodemographic data with accurate travel times to health services estimates, providing the basis for valuable indicators.

Postnatal maternal depressive symptoms and behavioural outcomes in term-born and preterm-born toddlers: a longitudinal UK community cohort study

Por: Kleine · I. · Vamvakas · G. · Lautarescu · A. · Falconer · S. · Chew · A. · Counsell · S. · Pickles · A. · Edwards · D. · Nosarti · C.
Objectives

To examine the association between maternal depressive symptoms in the immediate postnatal period and offspring’s behavioural outcomes in a large cohort of term-born and preterm-born toddlers.

Design and participants

Data were drawn from the Developing Human Connectome Project. Maternal postnatal depressive symptoms were assessed at term-equivalent age, and children’s outcomes were evaluated at a median corrected age of 18.4 months (range 17.3–24.3).

Exposure and outcomes

Preterm birth was defined as 1/2–5 Total (CBCL) and Quantitative Checklist for Autism in Toddlers (Q-CHAT) scores. Toddlers’ cognition was assessed with the Bayley Scales of Infant and Toddler Development—Third Edition (Bayley-III).

Results

Higher maternal EPDS scores were associated with toddlers’ higher CBCL (B=0.93, 95% CI 0.43 to 1.44, p2=0.05) and Q-CHAT scores (B=0.27, 95% CI 0.03 to 0.52, p=0.031, f2=0.01). Maternal EPDS, toddlers’ CBCL and Q-CHAT scores did not differ between preterm (n=97; 19.1% of the total sample) and term participants. Maternal EPDS score did not disproportionately affect preterm children with respect to CBCL or Q-CHAT scores.

Conclusions

Our findings indicate that children whose mothers reported increased depressive symptoms in the early postnatal period, including subclinical symptoms, exhibit more parent-reported behavioural problems in toddlerhood. These associations were independent of gestational age. Further research is needed to confirm the clinical significance of these findings.

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