Experiences Of Healthcare Providers Research Articles

Experiences of health care providers in the sociocultural context of the prevention of mother-to-child transmission of HIV in Ghana: A descriptive phenomenology

Experiences of health care providers in the sociocultural context of the prevention of mother-to-child transmission of HIV in Ghana: A descriptive phenomenology

Teledermatology and Virtual Visits for Acne Management: A Review.

Acne vulgaris is a common dermatological condition requiring individualized management. Teledermatology provides convenience and accessibility that is highly suitable for this dermatological condition. Herein, our review aimed to describe the current state of teledermatology in the context of acne management and to assess patient satisfaction, adherence to virtual care, and the experiences of health care providers in delivering remote dermatological services. A systematic search for articles was conducted in Medline, Embase, and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Title, abstract, full-text screening, and data abstraction were carried out in duplicate. One thousand one hundred three nonduplicate articles were screened based on title and abstract review. A total of 21 studies were included in the review. It was found that teledermatology is well-suited to the effective management of acne vulgaris. When compared to in-person care, teledermatology resulted in similar outcomes on several acne-grading scales. Additionally, patient satisfaction was comparable, with a large proportion of patients preferring virtual care to traditional in-person visits. However, compliance was found to be lower for virtual care. There are several secondary benefits to telemedicine, including time savings and greater accessibility to care for rural patients. Teledermatology is an evolving, promising medium for acne management for both clinicians and patients. Future research comparing the effectiveness of different teledermatology platforms, its limitations and pitfalls, and integration of patient and physician preferences to improve treatment outcomes is warranted.

Parental participation in newborn care in the view of health care providers in Uganda: a qualitative study

BackgroundEvidence suggests that family-centered care for sick newborns, where parents are co-caregivers in newborn care units, can result in increased breastfeeding frequency, higher weight gain, earlier discharge, and reduced parental anxiety. This study explored healthcare providers' perceptions and experiences of parental participation in care for sick newborns in the newborn care units in two high-volume maternity units in Uganda, with the aim of informing interventions that promote family-centered care for newborns.MethodsAn exploratory qualitative study was conducted between August and December 2023. Sixteen in-depth interviews were held at a regional and general hospital in the rural eastern region of Uganda. The interviews were audio-recorded and then transcribed, followed by a reflexive thematic analysis approach to generate themes.FindingsWe identified four key themes: (1) creating order to ensure the safety of newborns in the newborn care unit; (2) parental participation as a tool for overcoming workload in the Newborn care unit; (3) redirecting parental involvement to focus on medically endorsed newborn care practices; and (4) stress management targeting mothers to ensure newborn survival.ConclusionHealthcare providers encourage parents to participate in caring for their newborns in the newborn care units, mainly to reduce their workload. However, our study highlights the imbalanced nature of parental involvement, where HCPs control the tasks parents can or cannot perform, essentially deploying them as "assistants" rather than equal partners, contrary to the ideals of family-centered care. Transforming the current "healthcare provider-centered" model of caring for sick newborns to one that is family-centered will require training providers on the benefits of family-centered care and developing guidelines for its structured implementation within a resource-limited setting.

Healthcare Provider Narratives of the Impacts of the COVID-19 Pandemic on Pregnant and Parenting Youth in Canada: A Qualitative Study

The COVID-19 pandemic led to significant challenges for healthcare providers working with pregnant and parenting youth. However, the impacts of the pandemic on this population and healthcare services from the perspective of healthcare providers are not well documented in Canada. We examined the narratives and experiences of healthcare providers regarding these impacts and explored the challenges to service provision. Using a qualitative interpretative description (ID) approach, we recruited 25 health and service providers from Alberta, Ontario, and British Columbia for individual qualitative interviews. Our analysis resulted in three themes: complexities of health service provision during COVID-19, healthcare providers’ accounts of impacts on pregnant and parenting youth, and leveraging challenges into opportunities for service provision. Participants described the influence of pandemic policies and distancing measures on accessibility of health services, availability of healthcare resources and personnel, and well-being of their clients. They also reported increased mental health issues, isolation, and exacerbation of inequities within this population. Providers highlighted the role of telemedicine in ensuring some degree of continuity of care. Additionally, they commented on service adaptations to address the evolving needs of their clients. Our findings underline the need for a resilient and adaptable healthcare system that can better support the needs of vulnerable populations during crises.

Satisfaction with perinatal care providers and the childbirth experience: the moderating role of body mass index

BackgroundSatisfaction with birth and healthcare provider experiences have long-term effects for maternal health. Research has shown that mothers who report more trust, respect, and self-efficacy in their relationship with their healthcare providers are more likely to report positive birthing experiences. Further, individuals with obesity, including pregnant mothers, are more likely to experience weight-related stigma from healthcare providers which may negatively impact satisfaction with this relationship. Thus, the current study examines maternal pre-pregnancy body mass index (BMI) as a moderator between birth and provider satisfaction.MethodsA sample of 94 women (ages 16–38) were recruited during pregnancy. Participants completed surveys about their satisfaction with their birth experience, provider satisfaction, height, weight, and demographics including age and education. A moderation analysis was used to examine pre-pregnancy BMI as a moderator between birth and provider satisfaction.ResultsResults show that provider satisfaction is positively associated with birth satisfaction among mothers with moderate (overweight) to high (obese) pre-pregnancy BMI scores in our sample.ConclusionsFindings suggest that strengthening the patient-provider relationship may promote satisfaction with birth experiences.

Pandemic Action Plan: Phase 3-Lessons Learned from Implementation. "What Did We Learn?"

The COVID-19 pandemic created critical challenges for hospitals and health care providers. Suddenly clinics were forced to close; elective procedures were delayed; scheduled visits were canceled; emergency rooms were overcrowded; hospital beds, equipment, and personal protective equipment (PPE) were in short supply; and staff were faced with rapidly changing circumstances, care protocols, trauma, and personal risk. To better address challenges of the ongoing COVID-19 pandemic and prepare for future pandemics, the National Telemedicine Technology Assessment Resource Center (TTAC) was asked to develop a Pandemic Response Action Plan that would allow its users to address critical issues with available telemedicine and related technologies. The project was constructed in 3 phases. Phase 1-Develop a Pandemic Response Action Plan and a Pandemic Response Action Plan Policy and Regulatory Summary, which identifies the regulatory challenges as well as policy recommendations. Phase 2-Publish the Action Plan and the Policy and Regulatory Summary. Phase 3-Look at health care providers who used the approaches, tools, and technology in the Pandemic Action Plan and document the results. This document represents Phase 3. This document is Phase 3. In this report we look back at health care providers who used the approaches in the Phase 1 Pandemic Response Action Plan as published in Phase 2. In this document we report on the challenges and results of implementing parts of the Pandemic Action Plan. It records the findings, conclusions, and recommendations resulting from the experience of health care providers and the professional experiences of the team and their organizations in implementing parts or all of the plan. Methods: The same multidisciplinary team that constructed Phase 1 and Phase 2 were engaged to develop this Phase 3 report. The members of the team represent leadership expertise and key stakeholders in health care delivery during a pandemic (administration, infection control, physicians, nurses, public health, contingency planning, disaster response, and information technology) as well as a facilitator. For Phase 3, the group used structured brainstorming to define the findings, issues, and results of their own organizations' digital health response to the pandemic. In addition, eight health care providers (hospitals) identified by the Telemedicine Resource Centers' (TRCs) organizations, who used the Pandemic response Plan (created in Phases 1 and 2), were interviewed. All interviews were conducted by the same facilitator with leaders (CEO, and leaders of the telemedicine programs) in each of the eight programs, using a standard questionnaire created by the team. Current literature references are included in this report to illustrate when findings are known to have broader applicability. Conclusions: The impact of the COVID-19 Pandemic was severe and identified multiple critical challenges and weaknesses. Applying the approaches, tools, and technology outlined in the Pandemic Response Action Plan proved to be effective in addressing critical provider challenges. However, implementing these tools during a crisis was difficult unless the organization had experience with the tools and necessary workflows in advance. Implementing these tools as part of standard workflows and everyday operations increased the capabilities and resilience of these organizations in the provision of care during this and for future pandemics.

A qualitative descriptive study examining the impact of child‐raising experience on Japanese family doctors

AbstractBackgroundThe Patient‐Centered Clinical Method (PCCM) plays an important role in family doctors' ability to communicate effectively with patients. Although the parenting experiences of healthcare providers can be utilized to communicate with patients, it is unclear how they contribute to family doctors' practice.MethodsA qualitative descriptive study focusing on the parenting experiences of Japanese family doctors and their perceptions of how these experiences interfaced with their clinical practice of the PCCM was conducted. Participants were selected using snowball sampling, and the data were collected via semi‐structured interviews while recording online, which were transcribed verbatim and analyzed using qualitative descriptive analysis, with data‐derived codes being systematically applied and reflexively interpreted. The categories were refined concurrently with the interviews. Once it was established that no additional categories were required, the recruitment and analysis process was concluded.ResultsThe eight participants were recruited, and the following themes were extracted; these were “Developing patience and new perspectives through raising children,” “Empathizing with the experiences of others,” “Building awareness of social factors and home context,” “Reflecting on one's own words and behavior,” “Forming partnerships with patients through shared parenting experiences,” and “Facilitating interpersonal growth.”ConclusionThe communication skills that have been refined through personal experiences of raising children are transferable between professional and family situations. This research shows that such skills are not mutually exclusive to professional or family settings and can be used effectively to improve clinical practice as part of the PCCM model of consulting.

Navigating complexity: healthcare providers’ experiences with integrating physical health promotion in psychosis outpatient services in Sweden

Background Individuals with psychotic disorders face an increased risk of physical health issues, leading to reduced life expectancy. Despite recommendations to integrate physical health promotion into mental healthcare, challenges persist, and mortality from somatic diseases continues to rise. Understanding healthcare providers’ perspectives is crucial to overcoming these barriers. This study aims to explore the experiences of healthcare providers working in direct patient care and as unit heads regarding factors influencing health promotion in Swedish psychosis outpatient units. Methods A qualitative descriptive study was conducted in two specialized psychosis outpatient units. Thirteen healthcare providers, including clinical case managers and three heads of units, were individually interviewed. Thematic analysis was used to analyze the data. Results Three main themes were generated: (1) Health care providers’ attitudes and competence. The health care provider’s values and beliefs influenced the engagement in health promotion. (2) Patient-related aspects. Understanding how different patient life components shaped the physical health and need for measurements (3) Organizational prerequisites. Prioritizing resources and leadership impact the experience of health promotion. Clinical case management appeared as a promising approach to coordinate/integrate physical and mental health care, evident in themes 1 and 3. Conclusions Beyond organizational factors, healthcare providers’ skills, patient understanding, and ethical reflection influence their motivation to engage in physical health promotion. The study included only 13 participants, representing various professions, including managers who provided specific leadership perspectives. Clinical case managers appear well-suited to address physical health promotion due to their proficiency in shared decision-making and coordination.

Can "the expanded free maternity services" enable Kenya to achieve universal health coverage by 2030: qualitative study on experiences of mothers and healthcare providers.

Universal health coverage is a global agenda within the sustainable development goals. While nations are attempting to pursue this agenda, the pathways to its realization vary across countries in relation to service, quality, financial accessibility, and equity. Kenya is no exception and has embarked on an initiative, including universal coverage of maternal health services to mitigate maternal morbidity and mortality rates. The implementation of expanded free maternity services, known as the Linda Mama (Taking Care of the Mother) targets pregnant women, newborns, and infants by providing cost-free maternal healthcare services. However, the efficacy of the Linda Mama (LM) initiative remains uncertain. This article therefore explores whether LM could enable Kenya to achieve UHC. This descriptive qualitative study employs in-depth interviews, focus group discussions, informal conversations, and participant observation conducted in Kilifi County, Kenya, with mothers and healthcare providers. The findings suggest that Linda Mama has resulted in increased rates of skilled care births, improved maternal healthcare outcomes, and the introduction of comprehensive maternal and child health training for healthcare professionals, thereby enhancing quality of care. Nonetheless, challenges persist, including discrepancies and shortages in human resources, supplies, and infrastructure and the politicization of healthcare both locally and globally. Despite these challenges, the expanding reach of Linda Mama offers promise for better maternal health. Finally, continuous sensitization efforts are essential to foster trust in Linda Mama and facilitate progress toward universal health coverage in Kenya.

Healthcare Provider Experiences With Unvaccinated COVID-19 Patients: A Qualitative Study.

In the setting of an active pandemic the impact of public vaccine hesitancy on healthcare workers has not yet been explored. There is currently a paucity of literature that examines how patient resistance to disease prevention in general impacts practitioners. The COVID-19 pandemic created unprecedented healthcare challenges with impacts on healthcare workers' wellbeing. Vaccine hesitancy added complexity to providing care for unvaccinated patients. Our study qualitatively explored experiences of healthcare providers caring for unvaccinated patients with severe COVID-19 infection in the intensive care setting. We used interview-based constructivist grounded theory methodology to explore experiences of healthcare providers with critically ill unvaccinated COVID-19 patients. Healthcare providers who cared for unvaccinated patients with severe COVID-19 respiratory failure following availability of severe acute respiratory syndrome coronavirus 2 vaccines were recruited from seven ICUs located within two large academic centers and one community-based hospital. We interviewed 24 participants, consisting of eight attending physicians, seven registered nurses, six critical care fellows, one respiratory therapist, one physiotherapist, and one social worker between March 2022 and September 2022 (approximately 1.5 yr after the availability of COVID-19 vaccines in Canada). Interviews were recorded, transcribed, de-identified, and coded to identify emerging themes. The final data was analyzed to generate the thematic framework. Reflexivity was employed to reflect upon and discuss individual pre-conceptions and opinions that may impact collection and interpretation of the data. Healthcare providers maintained dedication toward professionalism during provision of care, at the cost of suffering emotional turmoil from the pandemic and COVID-19 vaccine hesitancy. Evolving sources of stress associated with vaccine hesitancy included ongoing high volumes of critically ill patients, resource shortages, and visitation restrictions, which contributed to perceived emotional distress, empathy loss, and professional dissatisfaction. As a result, there were profound personal and professional consequences for healthcare professionals, with perceived impacts on patient care. Our study highlights struggles of healthcare providers in fulfilling professional duties while navigating emotional stressors unique to vaccine hesitancy. System-based interventions should be explored to help providers navigate biases and moral distress, and to foster resilience for the next major healthcare system strain.

Healthcare Professionals' Experiences in Providing Palliative Care in an Intensive Care Unit in Indonesia: A Phenomenological Study.

In the Intensive Care Unit (ICU), it is vital to meticulously monitor symptoms and thoroughly understand the treatment objectives for critically ill patients. This highlights the necessity of integrating palliative care in this environment. Despite the potential advantages, several barriers impede the effective integration of palliative care in the ICU. Notably, many healthcare professionals (HCPs) in Indonesian ICUs have not fully leveraged the incorporation of palliative care. This study aimed to investigate and clarify the experiences of healthcare providers (HCPs) involved in administering palliative care to ICU patients in Indonesia. This research employed a qualitative descriptive phenomenological approach. Semi-structured, in-depth individual interviews were conducted with four nurses and three doctors working in an Indonesian hospital. Colaizzi's method was used for data analysis. The analysis identified six themes from the interviews, reflecting the experiences of healthcare professionals in delivering palliative care in the ICU. These themes are: 1) Provide Professional Caring, 2) Caring and curing collaboration, 3) Quality Intensive Communication, 4) End-of-Life Care, 5) Controlling Feelings, and 6) Provide Holistic Caring. Providing care for ICU patients demands not only the expertise of HCPs but also compassion, communication skills, and a holistic approach to patient care. By offering comprehensive palliative care in the ICU, healthcare professionals can address the diverse needs of patients and their families, promoting comfort, respect, and an improved quality of life throughout the illness. This inclusive approach enhances the experience for both patients and their families while supporting healthcare providers in delivering empathetic and patient-centered care. It is recommended that hospitals develop policies to enhance palliative care services in Indonesia.

The unmet mental health needs of adolescents with HIV in eastern Tanzania: Experiences of healthcare providers, adolescents, and caregivers.

Adolescents with Human Immunodeficiency Virus (HIV) are at greater risk for mental health problems than their HIV-negative counterparts. However, there is a dearth of evidence on the need for mental health services, including interventions for depression in adolescents with HIV (AWHIV), in most low- and middle-income countries (LMICs). This study's objective was to explore the unmet mental health needs of AWHIV to inform the development and implementation of a psychological intervention for depression in AWHIV in Dar es Salaam, Tanzania. A descriptive phenomenological qualitative study design was used. Consultative meetings with providers and 45 in-depth interviews were conducted with AWHIV, caregivers, and healthcare providers (HCPs) to explore their experiences and unmet mental health needs for AWHIV. Data from the consultative meetings were triangulated to validate the obtained information with those from interviews. Data were organized and managed with the aid of NVIvo-11. The thematic analysis framework guided data analysis. Five major themes emerged: Experience of complex symptoms, unmet need for services, impact of the unmet needs, ways utilized in managing symptoms, and preferred intervention. Complex depressive symptoms expressed as physical, behavioral, or somatic complaints adversely affected ART adherence and academic performance, led to substance use, and compromised overall quality of life in AWHIV. HIV-Care and Treatment Centers (HIV-CTCs) did not conduct formal mental health screenings. Instead, caregivers and HCPs addressed the symptoms of mental health problems with death threats and corporal punishments. No evidence-based depression interventions existed in HIV-CTCs for observed symptoms. This study reports on unmet mental health needs with a clear impact on the lives of AWHIV, which may have significant implications for treatment adherence. There is an urgent need to develop and implement effective and scalable interventions to address these mental health needs.

The dynamics of intercultural clinical encounters in times of pandemic crisis. Swedish healthcare providers’ reflections on social norms in relation to sexual and reproductive healthcare

BackgroundExperiences from the COVID-19 pandemic may help to better understand resilience, competences and skills for healthcare providers and the healthcare system. Within sexual and reproductive health inequalities for migrants exist and it is an area where promoting both cultural competency and healthcare equity in the clinical encounter is expected of healthcare providers yet can create tension. The aim is to explore healthcare providers experiences of encounters with migrants in the context of the pandemic and the subsequent changes in routines and norms. MethodsA qualitative study based on semi-structured interviews with 31 healthcare providers working in sexual and reproductive healthcare in southern Sweden. Interviews were conducted during the COVID-19 pandemic influencing how healthcare providers reflected on their experiences. Analysis was done using reflexive thematic data analysis. FindingsHealthcare providers reflected on how changes in routines increased the understanding of challenges and enablers in the intercultural encounter including the impact on communication and role of relatives and male partners. They emphasized the dynamics of culture in the clinical encounter and healthcare system through highlighting the importance of structural awareness, self-reflection and the flexibility of conducts and norms, often given a cultural connotation. ConclusionThe COVID-19 pandemic resulted in changes of previously established routines directly affecting clinical encounters, which provided a unique opportunity for healthcare providers to reflect, with communication and self-reflection being discussed as central in complex encounters. It highlighted the dynamics of presumed deeply rooted cultural norms and the interplay with social factors affecting healthcare providers and patients alike.

Healthcare providers' perceptions and experiences of kangaroo mother care for preterm infants in four neonatal intensive care units in China: a qualitative descriptive study.

Kangaroo mother care (KMC) is an evidence-based intervention that can effectively reduce morbidity and mortality in preterm infants, but it has yet to be widely implemented in health systems in China. Most qualitative studies on KMC for preterm infants focused on the experiences and influencing factors from the perspective of preterm infant parents, while neglecting the perspective of healthcare providers, who played a critical role in guiding KMC practice. Therefore, this study aimed to explore the perceptions and experiences of healthcare providers regarding their involvement in KMC implementation for preterm infants to promote the contextualized implementation of KMC. A descriptive qualitative approach was adopted. A purposive sampling was used to select healthcare providers involved in KMC implementation in the neonatal intensive care units (NICUs) as participants from four tertiary hospitals across four cities in Zhejiang Province, China. Face-to-face semi-structured interviews were conducted to collect information. Thematic analysis was employed to analyze the data. Seventeen healthcare professionals were recruited, including thirteen nurses and four doctors in the NICUs. Four themes and twelve subthemes emerged: different cognitions based on different perspectives (acknowledged effects and benefits, not profitable economically), ambivalent emotions regarding KMC implementation (gaining understanding, gratitude and trust from parents, not used to working under parental presence, and concerning nursing safety issues), barriers to KMC implementation (lack of unified norms and standards, lack of systematic training and communication platform, insufficient human resources, and inadequate parental compliance) and suggestions for KMC implementation (improving equipment and environment, strengthening collaboration between nurses and doctors, and support from hospital managers). Despite acknowledging the clinical benefits of KMC, the lack of economic incentives, concerns about potential risks, and various barriers hindered healthcare providers' intrinsic motivation to implement KMC in NICUs in China. To facilitate the effective implementation of KMC, hospital managers should provide bonuses and training programs for healthcare providers, while giving them recognition and encouragement to enhance their motivation to implement KMC.

Healthcare Providers' and Frontline Workers' Experiences of an Ebola Vaccine Trial in the Boende Health District of the Democratic Republic of the Congo.

This study explored the experiences of healthcare providers (HCPs) and frontline workers who were involved in an Ebola vaccine trial in the Democratic Republic of the Congo. The researchers interviewed a total of 99 participants (HCPs and frontline workers) living and working in the Boende health district during the period of the study, from February to March 2022. These individuals included a mix of trial participants and non-trial participants (staff of the trial, local health authorities, and head nurses of health centers). In-depth individual interviews, as well as focus group discussions (FGDs), were used to understand interviewees' experiences and perceptions. The data were analyzed to identify the main themes. The findings unveiled a multitude of positive experiences among interviewees/FGD participants. The commitment of the trial investigators to improve the study site and to equip the volunteers with necessary skills and knowledge greatly contributed to a positive trial experience. However, some interviewees felt that the reimbursement for time and travel expenses during their trial visits was insufficient in comparison with their expectations. Additionally, there were expressions of worry about the frequency of blood draws during scheduled trial visits. Our findings emphasize the critical importance of addressing and continuously considering the perspectives and concerns of trial participants before designing and implementing vaccine trials. By actively incorporating their inputs, researchers can mitigate concerns and tailor communication strategies, potentially enhancing the overall success and impact of the vaccine trial.

Experiences of healthcare providers and caregivers regarding health system bottlenecks affecting child healthcare service delivery in a rural district: Empirical qualitative study.

To explore the experiences of nurses and caregivers about the health system bottlenecks to the delivery of child healthcare services in a rural district in Ghana. The study employed a qualitative approach using an exploratory, descriptive design. Collection of data was through semi-structured, face-to-face interviews with 26 participants in the Nkwanta South Municipality, Ghana. Audio recordings of interviews were transcribed verbatim and analysed qualitatively. Inductive codes generated were organised into themes and sub-themes. The main health system bottlenecks that emerged were the poor state of in-patient facilities, inadequate basic logistics and persistent shortage of essential medicines needed for child healthcare delivery. Health system bottlenecks have the tendency to affect the treatment and hospitalisation outcomes of sick children and eventually impact the state of child healthcare negatively. Concerted efforts by government and local authorities to remove these barriers will help to improve child health and child health outcomes. A total of 26 participants comprising nurses and caregivers, agreed and participated in this study. Interviews with these participants were conducts either in the health facilities or in the communities where they live. Their responses contributed significantly to the content of this article.

Healthcare provider's experience and attitude towards the national health insurance program of Nepal

Healthcare provider's experience and attitude towards the national health insurance program of Nepal

Choosing non-pharmacological treatments for neuropathic pain in spinal cord injury: a qualitative study

Purpose The aims of this study were to explore (1) the considerations of people with spinal cord injury (SCI) in choosing to use non-pharmacological treatments (N-PTs) for neuropathic pain (NP), (2) which factors influence their decision and who is involved in this choice. Materials and methods Eleven individuals with SCI and NP were interviewed. Interviews were transcribed verbatim, transcripts were analysed through thematic coding, following an inductive content analysis approach. Results A journey towards finding and choosing N-PTs emerged. Key phases in this journey were: motives, strategy and practical considerations. Pain and its impact on their life led participants to consider N-PTs. Motives were participants’ negative attitudes towards regular medication, willingness to try everything and disappointment and frustration with the guidance from their health care provider (HCP). The search strategies often involved third parties and the internet. This led them to choose a specific N-PT. The journey was influenced by one’s attitude, previous personal experience, experience of HCPs, financial considerations, availability and convenience of the treatment. Conclusions The journey individuals with SCI and NP go through to find N-PTs to manage pain is difficult and often lonely. Findings highlight the importance of HCPs accompanying people with SCI in finding N-PTs.

Clinical development and marketing application review times for novel orphan-designated drugs.

Development of an orphan-designated drug has been more challenging and financially less attractive than that of other drugs due to low prevalence of the condition, poorly defined biomarkers and lack of experience of healthcare providers in diagnosing and treating the condition. Guidance and incentives in some countries support the sponsors in developing orphan-designated drugs despite the challenges. Expedited regulatory programs as offered by the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) support the development of drugs, provide shorter marketing application review times or provide preliminary approval. In this study, we analyze marketing application review times in the US and in the European Union (EU) and clinical development times for novel, i.e., containing new molecular entity, orphan-designated drugs that were approved in the US between 1 June 2020 and 31 May 2023, and their correlation with expedited regulatory programs. Seventy-three marketing applications for novel orphan-designated drugs were approved by the FDA, and 39 also received a positive opinion from the EMA. The marketing application review time by the FDA for the 73 novel orphan-designated drugs approved in the US was 244 days (n = 73, median), and the marketing application review time by the EMA for the 39 drugs that were also approved in the EU was 353 days (n = 39, median). The typical clinical development time for a novel orphan-designated drug was 7.2 years (n = 72).

Laryngeal Mask Airway in Neonatal Resuscitation: A Survey of the Union of European Neonatal and Perinatal Societies

Introduction: Laryngeal mask airway (LMA) use in neonatal resuscitation is limited despite existing evidence and recommendations. This survey investigated the knowledge and experience of healthcare providers on the use of the LMA and explored barriers and solutions for implementation. Methods: This online, cross-sectional survey on LMA in neonatal resuscitation involved healthcare professionals of the Union of European Neonatal and Perinatal Societies (UENPS). Results: A total of 858 healthcare professionals from 42 countries participated in the survey. Only 6% took part in an LMA-specific course. Some delivery rooms were not equipped with LMA (26.1%). LMA was mainly considered after the failure of a face mask (FM) or endotracheal tube (ET), while the first choice was limited to neonates with upper airway malformations. LMA and FM were considered easier to position but less effective than ET, while LMA was considered less invasive than ET but more invasive than FM. Participants felt less competent and experienced with LMA than FM and ET. The lack of confidence in LMA was perceived as the main barrier to its implementation in neonatal resuscitation. More training, supervision, and device availability in delivery wards were suggested as possible actions to overcome those barriers. Conclusion: Our survey confirms previous findings on limited knowledge, experience, and confidence with LMA, which is usually considered an option after the failure of FM/ET. Our findings highlight the need for increasing the availability of LMA in delivery wards. Moreover, increasing LMA training and having an LMA expert supervisor during clinical practice may improve the implementation of LMA use in neonatal clinical practice.