scholarly journals Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review

Pharmaceutics ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 695
Author(s):  
Beate Aurich ◽  
Evelyne Jacqz-Aigrain
Keyword(s):  
Scoping Review ◽  
Healthcare Providers ◽  
Safety Data ◽  
Population Based ◽  
Paediatric Research ◽  
Exclusion Criteria ◽  
Protocol Development ◽  
Paediatric Drug Development ◽  
Safety Specification ◽  
Practical Guidance

Translational paediatric drug development includes the exchange between basic, clinical and population-based research to improve the health of children. This includes the assessment of treatment related risks and their management. The objectives of this scoping review were to search and summarise the literature for practical guidance on how to establish a paediatric safety specification and its integration into a paediatric protocol. PubMed, Embase, Web of Science, and websites of regulatory authorities and learned societies were searched (up to 31 December 2020). Retrieved citations were screened and full texts reviewed where applicable. A total of 3480 publications were retrieved. No article was identified providing practical guidance. An introduction to the practical aspects of paediatric safety profiling and protocol development is provided by combining health authority and learned society guidelines with the specifics of paediatric research. The paediatric safety specification informs paediatric protocol development by, for example, highlighting the need for a pharmacokinetic study prior to a paediatric trial. It also informs safety related protocol sections such as exclusion criteria, safety monitoring and risk management. In conclusion, safety related protocol sections require an understanding of the paediatric safety specification. Safety data from carefully planned paediatric research provide valuable information for children, parents and healthcare providers.

Professional experiences of formal healthcare providers in the provision of medical assistance in dying (MAiD): A scoping review

2021 ◽  
pp. 1-15
Author(s):  
Valerie Ward ◽  
Shannon Freeman ◽  
Taylor Callander ◽  
Beibei Xiong
Keyword(s):  
Scoping Review ◽  
Positive Emotions ◽  
Healthcare Providers ◽  
Medical Assistance ◽  
Exclusion Criteria ◽  
Nursing Support ◽  
Team Members ◽  
Medical Assistance In Dying ◽  
Professional Experiences ◽  
The Usa

Abstract Objective This scoping review describes the existing literature which examines the breadth of healthcare providers’ (HCP's) experiences with the provision of medical assistance in dying (MAiD). Method This study employed a scoping review methodology: (1) identify research articles, (2) identify relevant studies, (3) select studies based on inclusion/exclusion criteria, (4) chart the data, and (5) summarize the results. Results In total, 30 papers were identified pertaining to HCP's experiences of providing MAiD. Fifty-three percent of the papers were from Europe (n = 16) and 40% of studies were from the USA or Canada (n = 12). The most common participant populations were physicians (n = 17) and nurses (n = 12). This scoping review found that HCPs experienced a variety of emotional responses to providing or providing support to MAiD. Some HCPs experienced positive emotions through helping patients at the end of the patient's life. Still other HCPs experienced very intense and negative emotions such as immense internal moral conflict. HCPs from various professions were involved in various aspects of MAiD provision such as responding to initial requests for MAiD, supporting patients and families, nursing support during MAiD, and the administration of medications to end of life. Significance of results This review consolidates many of the experiences of HCPs in relation to the provision of MAiD. Specifically, this review elucidates many of the emotions that HCPs experience through participation in MAiD. In addition to describing the emotional experiences, this review highlights some of the roles that HCPs participate in with relation to MAiD. Finally, this review accentuates the importance of team supports and self-care for all team members in the provision of MAiD regardless of their degree of involvement.

scholarly journals Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review

2018 ◽  
Vol 2 (1) ◽  
pp. e000298 ◽  
Author(s):  
Marcela Colom ◽  
Peter Rohloff
Keyword(s):  
Informed Consent ◽  
Scoping Review ◽  
Individual Autonomy ◽  
Paediatric Research ◽  
Low Literacy ◽  
Middle Income ◽  
Middle Income Countries ◽  
Research With Children ◽  
Low Middle Income Countries ◽  
Practical Guidance

IntroductionConducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.MethodsWe conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.ResultsThe search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.ConclusionsA scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children’s own assent to participate in research.

scholarly journals Stillbirth outcome capture and classification in population-based surveys: EN-INDEPTH study

2021 ◽  
Vol 19 (S1) ◽  
Author(s):  
Hannah Blencowe ◽  
◽  
Matteo Bottecchia ◽  
Doris Kwesiga ◽  
Joseph Akuze ◽  
...  
Keyword(s):  
Gestational Age ◽  
A Priori ◽  
Healthcare Providers ◽  
Population Based ◽  
Reproductive Age ◽  
Group Discussions ◽  
Cross Sectional ◽  
Vital Status ◽  
Neonatal Deaths ◽  
Adverse Pregnancy

Abstract Background Household surveys remain important sources of stillbirth data, but omission and misclassification are common. Classifying adverse pregnancy outcomes as stillbirths requires accurate reporting of vital status at birth and gestational age or birthweight for every pregnancy. Further categorisation, e.g. by sex, or timing (intrapartum/antepartum) improves data to understand and prevent stillbirth. Methods We undertook a cross-sectional population-based survey of women of reproductive age in five health and demographic surveillance system sites in Bangladesh, Ethiopia, Ghana, Guinea-Bissau and Uganda (2017–2018). All women answered a full birth history with pregnancy loss questions (FBH+) or a full pregnancy history (FPH). A sub-sample across both groups were asked additional stillbirth questions. Questions were evaluated using descriptive measures. Using an interpretative paradigm and phenomenology methodology, focus group discussions with women exploring barriers to reporting birthweight for stillbirths were conducted. Thematic analysis was guided by an a priori codebook. Results Overall 69,176 women reported 98,483 livebirths (FBH+) and 102,873 pregnancies (FPH). Additional questions were asked for 1453 stillbirths, 1528 neonatal deaths and 12,620 surviving children born in the 5 years prior to the survey. Completeness was high (> 99%) for existing FBH+/FPH questions on signs of life at birth and gestational age (months). Discordant responses in signs of life at birth between different questions were common; nearly one-quarter classified as stillbirths on FBH+/FPH were reported born alive on additional questions. Availability of information on gestational age (weeks) (58.1%) and birthweight (13.2%) was low amongst stillbirths, and heaping was common. Most women (93.9%) were able to report the sex of their stillborn baby. Response completeness for stillbirth timing (18.3–95.1%) and estimated proportion intrapartum (15.6–90.0%) varied by question and site. Congenital malformations were reported in 3.1% stillbirths. Perceived value in weighing a stillborn baby varied and barriers to weighing at birth a nd knowing birthweight were common. Conclusions Improving stillbirth data in surveys will require investment in improving the measurement of vital status, gestational age and birthweight by healthcare providers, communication of these with women, and overcoming reporting barriers. Given the large burden and effect on families, improved data must be made available to end preventable stillbirths.

scholarly journals Young adults’ perceptions of living with atopic dermatitis in relation to the concept of self-management: a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044777
Author(s):  
Susanne Lundin ◽  
Marina Jonsson ◽  
Carl-Fredrik Wahlgren ◽  
Emma Johansson ◽  
Anna Bergstrom ◽  
...  
Keyword(s):  
Young Adults ◽  
Atopic Dermatitis ◽  
Qualitative Study ◽  
Healthcare Providers ◽  
Transition Process ◽  
Population Based ◽  
Self Management ◽  
School Age ◽  
Perceived Availability ◽  
Semistructured Interviews

ObjectivesLearning to take control of one’s health is an important part of the transition from adolescence to adulthood. This study aimed to explore young adults’ perceptions of living with atopic dermatitis (AD) in relation to the concept of self-management.DesignA qualitative study with an inductive approach was performed through semistructured interviews (n=15). The interviews were recorded, transcribed verbatim and analysed with systematic text condensation.ParticipantsYoung adults (mean age 23,4 years) with persistent AD in a longitudinal population-based birth cohort. To capture experience of living with persistent AD (preschool/school-age onset) of different severity (mild to severe/very severe), a purposive selection was performed. In total, 15 young adults were included. Persistent AD (preschool/school-age onset) was defined as dry skin in combination with itchy rash of typical localisation in the 12 months preceding the 16-year and the 24-year follow-ups. Severity was self-assessed using the Patient Oriented Eczema Measure.ResultsDespite having experience of AD since childhood, the respondents expressed uncertainty about treatment and how it affected their bodies. Their uncertainties and feelings affected how they used topical corticosteroids. The respondents emphasised that they perceived availability of healthcare and knowledge about treatment of AD among healthcare providers to be limited. The participants did not state any experiences of support to self-management from healthcare, which affect young adults’ possibilities to take full control of their AD care.ConclusionsYoung adults with preschool/school-age onset of AD are unsure how to treat and manage the disease. One explanation may be insufficient transition process.

scholarly journals Immunotherapy in hepatocellular carcinoma: evaluation and management of adverse events associated with atezolizumab plus bevacizumab

2021 ◽  
Vol 13 ◽  
pp. 175883592110311
Author(s):  
Chiun Hsu ◽  
Lorenza Rimassa ◽  
Hui-Chuan Sun ◽  
Arndt Vogel ◽  
Ahmed O. Kaseb
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Safety Data ◽  
Standard Of Care ◽  
Antiangiogenic Agents ◽  
Efficacy And Safety ◽  
First Line

In light of positive efficacy and safety findings from the IMbrave150 trial of atezolizumab plus bevacizumab, this novel combination has become the preferred first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). Several additional trials are ongoing that combine an immune checkpoint inhibitor with another agent such as a multiple kinase inhibitor or antiangiogenic agent. Therefore, the range of first-line treatment options for unresectable HCC is likely to increase, and healthcare providers need succinct information about the use of such combinations, including their efficacy and key aspects of their safety profiles. Here, we review efficacy and safety data on combination immunotherapies and offer guidance on monitoring and managing adverse events, especially those associated with atezolizumab plus bevacizumab. Because of their underlying liver disease and high likelihood of portal hypertension, patients with unresectable HCC are at particular risk of gastrointestinal bleeding, and this risk may be exacerbated by treatments that include antiangiogenic agents. Healthcare providers also need to be alert to the risks of proteinuria and hypertension, colitis, hepatitis, and reactivation of hepatitis B or C virus infection. They should also be aware of the possibility of rarer but potentially life-threatening adverse events such as pneumonitis and cardiovascular events. Awareness of the risks associated with these therapies and knowledge of adverse event monitoring and management will become increasingly important as the therapeutic range broadens in unresectable HCC.

scholarly journals A scoping review of registry captured indicators for evaluating quality of critical care in ICU

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Issrah Jawad ◽  
Sumayyah Rashan ◽  
Chathurani Sigera ◽  
Jorge Salluh ◽  
Arjen M. Dondorp ◽  
...  
Keyword(s):  
Critical Care ◽  
Scoping Review ◽  
Health Care Quality ◽  
Grey Literature ◽  
Healthcare Providers ◽  
Evidence Base ◽  
Patient Reported Outcome ◽  
Care Quality ◽  
Patient Reported

Abstract Background Excess morbidity and mortality following critical illness is increasingly attributed to potentially avoidable complications occurring as a result of complex ICU management (Berenholtz et al., J Crit Care 17:1-2, 2002; De Vos et al., J Crit Care 22:267-74, 2007; Zimmerman J Crit Care 1:12-5, 2002). Routine measurement of quality indicators (QIs) through an Electronic Health Record (EHR) or registries are increasingly used to benchmark care and evaluate improvement interventions. However, existing indicators of quality for intensive care are derived almost exclusively from relatively narrow subsets of ICU patients from high-income healthcare systems. The aim of this scoping review is to systematically review the literature on QIs for evaluating critical care, identify QIs, map their definitions, evidence base, and describe the variances in measurement, and both the reported advantages and challenges of implementation. Method We searched MEDLINE, EMBASE, CINAHL, and the Cochrane libraries from the earliest available date through to January 2019. To increase the sensitivity of the search, grey literature and reference lists were reviewed. Minimum inclusion criteria were a description of one or more QIs designed to evaluate care for patients in ICU captured through a registry platform or EHR adapted for quality of care surveillance. Results The search identified 4780 citations. Review of abstracts led to retrieval of 276 full-text articles, of which 123 articles were accepted. Fifty-one unique QIs in ICU were classified using the three components of health care quality proposed by the High Quality Health Systems (HQSS) framework. Adverse events including hospital acquired infections (13.7%), hospital processes (54.9%), and outcomes (31.4%) were the most common QIs identified. Patient reported outcome QIs accounted for less than 6%. Barriers to the implementation of QIs were described in 35.7% of articles and divided into operational barriers (51%) and acceptability barriers (49%). Conclusions Despite the complexity and risk associated with ICU care, there are only a small number of operational indicators used. Future selection of QIs would benefit from a stakeholder-driven approach, whereby the values of patients and communities and the priorities for actionable improvement as perceived by healthcare providers are prioritized and include greater focus on measuring discriminable processes of care.

scholarly journals Physical Activity Advice and Counselling by Healthcare Providers: A Scoping Review

Healthcare ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 609
Author(s):  
Uchenna Benedine Okafor ◽  
Daniel Ter Goon
Keyword(s):  
Physical Activity ◽  
Pregnant Women ◽  
Scoping Review ◽  
Post Partum ◽  
Healthcare Providers ◽  
Original Research ◽  
Eligibility Criteria ◽  
Physical Activity Advice ◽  
Scoping Reviews ◽  
Physical Activity And Exercise

Background: Despite scientific evidence on prenatal physical activity and exercise, synthesized evidence is lacking on the provision of prenatal physical activity and exercise advice and counselling by prenatal healthcare providers. The scoping review seeks to fill this gap by synthesizing available literature on the provision of prenatal physical activity and exercise advice and counselling by prenatal healthcare providers to women during antenatal visits. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) search framework for scoping reviews was applied to retrieve original research articles on the prenatal physical activity and exercise practices of healthcare providers with pregnant women, published between 2010–2020, and available in English. The search databases included Google Scholar, PubMed, Science Direct, Scopus, EMBASE, The Cumulative Index for Nursing and Allied Health Literature (CINAHL), BIOMED Central, Medline and African Journal Online. Studies that fulfilled the eligibility criteria were retrieved for analysis. Results: Out of the 82 articles that were retrieved for review, 13 met the eligibility criteria. Seven of the articles were quantitative, four qualitative, one mixed-method and one controlled, non-randomised study, respectively. Three themes emerged as major findings. Healthcare providers affirmed their responsibility in providing prenatal physical activity advice and counselling to pregnant women; however, they seldom or rarely performed this role. Major barriers to prenatal physical activity and exercise included insufficient time, lack of knowledge and skills, inadequate or insufficient training, and lack of resources. Conclusion: This review highlights salient features constraining the uptake of prenatal physical activity and exercise advice/counselling by prenatal healthcare providers in both community and clinical settings. Prenatal physical activity advice and counselling are key components to the promotion of physical activity adherence during and post-partum pregnancy; this requires adequate knowledge of physical activity prescriptions and recommendations, which are personalised and contextual to environment. Research is needed to examine the prenatal physical activity advice and counselling from prenatal healthcare providers on issues hindering effective delivery of the aforementioned in the context of promoting prenatal physical activity in clinical or community settings.

scholarly journals Military spouses with deployed partners are at greater risk of poor perinatal mental health: a scoping review

2019 ◽  
Vol 165 (5) ◽  
pp. 363-370 ◽  
Author(s):  
Lauren Rose Godier-McBard ◽  
L Ibbitson ◽  
C Hooks ◽  
M Fossey
Keyword(s):  
Mental Health ◽  
Social Support ◽  
Scoping Review ◽  
Healthcare Providers ◽  
Well Being ◽  
Perinatal Period ◽  
Poor Mental Health ◽  
Adverse Outcomes ◽  
Military Spouses ◽  
Perinatal Mental Health

BackgroundPoor mental health in the perinatal period is associated with a number of adverse outcomes for the individual and the wider family. The unique circumstances in which military spouses/partners live may leave them particularly vulnerable to developing perinatal mental health (PMH) problems.MethodsA scoping review was carried out to review the literature pertaining to PMH in military spouses/partners using the methodology outlined by Arksey and O’Malley (2005). Databases searched included EBSCO, Gale Cengage Academic OneFile, ProQuest and SAGE.ResultsThirteen papers fulfilled the inclusion criteria, all from the USA, which looked a PMH or well-being in military spouses. There was a strong focus on spousal deployment as a risk factor for depressive symptoms and psychological stress during the perinatal period. Other risk factors included a lack of social/emotional support and increased family-related stressors. Interventions for pregnant military spouses included those that help them develop internal coping strategies and external social support.ConclusionsUS literature suggests that military spouses are particularly at risk of PMH problems during deployment of their serving partner and highlights the protective nature of social support during this time. Further consideration needs to be made to apply the findings to UK military spouses/partners due to differences in the structure and nature of the UK and US military and healthcare models. Further UK research is needed, which would provide military and healthcare providers with an understanding of the needs of this population allowing effective planning and strategies to be commissioned and implemented.

Wearable Sensors and Their Metrics for Measuring Comprehensive Occupational Fatigue: A Scoping Review

2017 ◽  
Vol 61 (1) ◽  
pp. 1041-1045 ◽  
Author(s):  
Yibo Zhu ◽  
Rasik R Jankay ◽  
Laura C Pieratt ◽  
Ranjana K. Mehta
Keyword(s):  
Heart Rate ◽  
Scoping Review ◽  
Wearable Sensors ◽  
Health And Safety ◽  
Exclusion Criteria ◽  
Multidimensional Construct ◽  
Ovid Medline ◽  
Rate Sensor ◽  
Sleep Length ◽  
Occupational Fatigue

Extensive research has been conducted to study the effects of physical and sleep related fatigue on occupational health and safety. However, fatigue is a complex multidimensional construct, that is task- and occupation-dependent, and our knowledge on how to measure this complex construct is limited. A scoping review was conducted to: 1) review sensors and their metrics currently employed in occupational fatigue studies, 2) identify overlap between sensors and associated metrics that can be leveraged to assess comprehensive fatigue, 3) investigating the effectiveness of the sensors/metrics, and 4) recommended potential sensor/metric combinations to evaluate comprehensive fatigue. 512 unique abstracts were identified through Ovid-MEDLINE, MEDLINE, Embase and Cinal databases and application of the inclusion/exclusion criteria resulted in 27 articles that were included for the review. Heart rate sensors and actigraphs were identified to be the most suitable devices to study comprehensive fatigue. Heart rate trend within the heart rate sensor, and sleep length and sleep efficiency within actigraphs were found to be the most popular and reliable metrics for measuring occupational fatigue.

Mobility Assistants to Support Multi-Modal Routes in Smart Cities: A Scoping Review

2021 ◽  
Vol 3 (1) ◽  
pp. 26-40
Author(s):  
Nelson Pacheco Rocha ◽  
Gonçalo Santinha ◽  
Mário Rodrigues ◽  
Carlos Rodrigues ◽  
Alexandra Queirós ◽  
...  
Keyword(s):  
Scoping Review ◽  
Early Stage ◽  
Smart Cities ◽  
Research Trends ◽  
Exclusion Criteria ◽  
Major Barrier ◽  
Stage Of Development ◽  
Electronic Search ◽  
Inclusion Results

Objectives - This study aimed to identify: (i) the current research trends related to mobility assistants to support multi-modal routes in smart cities; (ii) the types of smart cities’ data being used; (iii) the methods applied to assess the proposed solutions; and iv) the major barriers for their dissemination. Methods - An electronic search was conducted in several databases, combining relevant keywords. Then titles and abstracts were screened against inclusion and exclusion criteria. Finally, the full texts of the eligible articles were retrieved and screened for inclusion. Results - A total of 19 articles were included. These articles either propose algorithms to optimize routes planning or presenting specific applications that make use of a broad range of smart cities’ data. Conclusion - The number of included articles is very reduced when compared with the total number of articles related to smart cities, which means that the mobility assistants to support multi-modal routes are still not significant within the smart cities’ research. Moreover, most of the included articles report applications in an early stage of development, which is a major barrier for the respective dissemination.

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