Elisabeth Darj
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Elisabeth Darj has a total of 107 co-authors. Here are the top co-authors by number of shared publications:
- Maria Lisa Odland
Institute of Applied Health Research, University of Birmingham, Birmingham, UK
6 shared publications - Andrea Barnabas Pembe
Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
5 shared publications - Jon Øyvind Odland
Department of Public Health and Nursing, Norwegian University of Science and Technology, 7491 Trondheim, Norway
5 shared publications - Anders Aune
Faculty of Medicine and Health Sciences, Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway
4 shared publications - Lennarth Nyström
Division of Epidemiology and Global Health, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden
4 shared publications - Anders Carlstedt
Department of Surgery, Central Hospital, Karlstad, Sweden
3 shared publications
Latest Publications
- Open Access
- 5 August 2026
- Published by Taylor & Francis in International Journal of Circumpolar Health
- Vol. 85 (1)
Experiences of a postpartum depression prevention programme in a circumpolar setting: insights from pregnant women and healthcare providers
Maternal mental health in the postpartum period is a key determinant of maternal well-being and early child development, particularly during the first 1,000 days of life [1,2]. Postpartum depressio...
- 5 August 2026
- Published by Taylor & Francis in International Journal of Circumpolar Health
- Vol. 85 (1)
Open AccessExperiences of a postpartum depression prevention programme in a circumpolar setting: insights from pregnant women and healthcare providers
Maternal mental health in the postpartum period is a key determinant of maternal well-being and early child development, particularly during the first 1,000 days of life [1,2]. Postpartum depressio...
- Open Access
- 7 August 2024
- Published by Taylor & Francis in Global Health Action
- Vol. 17 (1) , 2385177
Challenges and possible improvements for healthcare teams at outreach clinics in Nepal – a qualitative study
All Nepalese citizens have the right to high-quality healthcare services free of charge. To achieve this, healthcare services for the rural population in Nepal need to be improved in terms of personnel, medicines, and medical equipment. To explore challenges and possible improvements healthcare personnel experience when travelling to rural parts of Nepal to provide healthcare. Data was collected from various health professionals using focus group discussions at Dhulikhel Hospital in Nepal. The data were transcribed and analysed using Systematic text condensation. Twenty-two professional healthcare personnel participated in five group discussions. Four categories emerged from the collected material: Finding ORC services being underutilised, Wanting to fulfil tasks and do a good job, Facing inadequate resources, and Seeing the need for improved organisation and cooperation. There was consensus that rural clinics are important to maintaining health for the rural population of Nepal. However, there was frustration that the rural population was not benefitting from all available healthcare services due to underutilisation. Rural healthcare clinics are not utilised appropriately, according to healthcare workers at the rural outreach clinics. Potential ways of overcoming the perceived challenges of underutilising available healthcare services include financial and human resources. The rural population´s health awareness needs to be increased, and the work environment for rural healthcare workers needs to be improved. These issues need to be prioritised by the government and policymakers.
- 7 August 2024
- Published by Taylor & Francis in Global Health Action
- Vol. 17 (1) , 2385177
Open AccessChallenges and possible improvements for healthcare teams at outreach clinics in Nepal – a qualitative study
All Nepalese citizens have the right to high-quality healthcare services free of charge. To achieve this, healthcare services for the rural population in Nepal need to be improved in terms of personnel, medicines, and medical equipment. To explore challenges and possible improvements healthcare personnel experience when travelling to rural parts of Nepal to provide healthcare. Data was collected from various health professionals using focus group discussions at Dhulikhel Hospital in Nepal. The data were transcribed and analysed using Systematic text condensation. Twenty-two professional healthcare personnel participated in five group discussions. Four categories emerged from the collected material: Finding ORC services being underutilised, Wanting to fulfil tasks and do a good job, Facing inadequate resources, and Seeing the need for improved organisation and cooperation. There was consensus that rural clinics are important to maintaining health for the rural population of Nepal. However, there was frustration that the rural population was not benefitting from all available healthcare services due to underutilisation. Rural healthcare clinics are not utilised appropriately, according to healthcare workers at the rural outreach clinics. Potential ways of overcoming the perceived challenges of underutilising available healthcare services include financial and human resources. The rural population´s health awareness needs to be increased, and the work environment for rural healthcare workers needs to be improved. These issues need to be prioritised by the government and policymakers.
- Open Access
- 3 June 2024
- Published by Taylor & Francis in Global Health Action
- Vol. 17 (1) , 2354008
Awareness of postpartum depression among midwives and pregnant women in Arkhangelsk, Arctic Russia
Postpartum depression (PPD) affects approximately 17% of the women worldwide with nearly half of all cases going undetected. More research on maternal mental health, particularly among healthcare professionals and pregnant mothers, could help identify PPD risks and reduce its prevalence. Given that awareness of PPD is a crucial preventive factor, we studied PPD awareness among midwives and pregnant women in Arkhangelsk, Arctic Russia. A qualitative study was conducted using in-depth semi-structured interviews. Midwives and pregnant women were recruited from the women's clinic of the Arkhangelsk municipal polyclinic. Seven midwives and 12 pregnant mothers were interviewed. Midwives described limited time for psychological counselling of pregnant women; they reported that their primary focus was on the physiological well-being of women. Pregnant women have expressed a desire for their families to share responsibilities. The participants considered PPD as a mix of psychological and physiological symptoms, and they also highlighted a discrepancy between the expectations of pregnant women and the reality of motherhood. The present study underscored the limited understanding of PPD identification. The findings suggest that there is a need for increased awareness among midwives and pregnant women regarding PPD. Prevention programs targeting PPD with a specific emphasis on enhancing maternal mental health knowledge are warranted.
- 3 June 2024
- Published by Taylor & Francis in Global Health Action
- Vol. 17 (1) , 2354008
Open AccessAwareness of postpartum depression among midwives and pregnant women in Arkhangelsk, Arctic Russia
Postpartum depression (PPD) affects approximately 17% of the women worldwide with nearly half of all cases going undetected. More research on maternal mental health, particularly among healthcare professionals and pregnant mothers, could help identify PPD risks and reduce its prevalence. Given that awareness of PPD is a crucial preventive factor, we studied PPD awareness among midwives and pregnant women in Arkhangelsk, Arctic Russia. A qualitative study was conducted using in-depth semi-structured interviews. Midwives and pregnant women were recruited from the women's clinic of the Arkhangelsk municipal polyclinic. Seven midwives and 12 pregnant mothers were interviewed. Midwives described limited time for psychological counselling of pregnant women; they reported that their primary focus was on the physiological well-being of women. Pregnant women have expressed a desire for their families to share responsibilities. The participants considered PPD as a mix of psychological and physiological symptoms, and they also highlighted a discrepancy between the expectations of pregnant women and the reality of motherhood. The present study underscored the limited understanding of PPD identification. The findings suggest that there is a need for increased awareness among midwives and pregnant women regarding PPD. Prevention programs targeting PPD with a specific emphasis on enhancing maternal mental health knowledge are warranted.
- Open Access
- 13 July 2023
- Published by African Journals Online (AJOL) in African Health Sciences
- Vol. 23 (2) , 193-201
Challenges and recommendations for addressing under-five pneumonia morbidity and mortality in Nigeria
Background: Pneumonia is a severe infection and one of the most common causes of mortality among children under five years of age, when not appropriately managed. Infection of the lungs by bacteria, viruses, or fungi and consequent inflammation may lead to cough and difficult breathing. Some of the key predisposing factors are malnutrition and air pollution. WHO reports that Africa has the highest burden of global child mortality, and 16% of all deaths in pneumonia, were children under five years of age in 2016. Objectives: This study aimed to explore how health providers perceive pneumonia as a cause of under-five mortality in Nigeria. Methods: A qualitative study design with in-depth interviews and focus group discussions was used to explore and understand nurses and pediatricians' views regarding the pneumonia situation, vaccinations, and preventive suggestions to reduce under five pneumonia deaths in Nigeria. Results: Two themes and four categories emerged: participant’s anxiety over the situation, their views on impediments, current policies and strategies, and suggestions on addressing severe pneumonia. Conclusions: The results from this study highlight contextual issues playing major roles in pneumonia mortality among children in Nigeria, which will need approaches on several levels to address them. Keywords: Pneumonia; children; under five mortality; Nigeria; vaccinations; barriers.
- 13 July 2023
- Published by African Journals Online (AJOL) in African Health Sciences
- Vol. 23 (2) , 193-201
Open AccessChallenges and recommendations for addressing under-five pneumonia morbidity and mortality in Nigeria
Background: Pneumonia is a severe infection and one of the most common causes of mortality among children under five years of age, when not appropriately managed. Infection of the lungs by bacteria, viruses, or fungi and consequent inflammation may lead to cough and difficult breathing. Some of the key predisposing factors are malnutrition and air pollution. WHO reports that Africa has the highest burden of global child mortality, and 16% of all deaths in pneumonia, were children under five years of age in 2016. Objectives: This study aimed to explore how health providers perceive pneumonia as a cause of under-five mortality in Nigeria. Methods: A qualitative study design with in-depth interviews and focus group discussions was used to explore and understand nurses and pediatricians' views regarding the pneumonia situation, vaccinations, and preventive suggestions to reduce under five pneumonia deaths in Nigeria. Results: Two themes and four categories emerged: participant’s anxiety over the situation, their views on impediments, current policies and strategies, and suggestions on addressing severe pneumonia. Conclusions: The results from this study highlight contextual issues playing major roles in pneumonia mortality among children in Nigeria, which will need approaches on several levels to address them. Keywords: Pneumonia; children; under five mortality; Nigeria; vaccinations; barriers.
- Open Access
- 28 February 2023
- Published by JMIR Publications Inc. in JMIR Pediatrics and Parenting
- Vol. 6 (1) , e40463
Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study
Background: Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. Objective: This study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings. Methods: We used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server. Results: Three iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%). Conclusions: Our smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.
- 28 February 2023
- Published by JMIR Publications Inc. in JMIR Pediatrics and Parenting
- Vol. 6 (1) , e40463
Open AccessIterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study
Background: Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. Objective: This study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings. Methods: We used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server. Results: Three iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%). Conclusions: Our smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.
- Open Access
- 3 December 2022
- Published by Springer Nature in BMC Health Services Research
- Vol. 22 (1) , 1-11
Health care providers’ perceptions of using misoprostol in the treatment of incomplete abortion in Malawi
Background: In Malawi, abortion is only legal to save a pregnant woman’s life. Treatment for complications after unsafe abortions has a massive impact on the already impoverished health care system. Even though manual vacuum aspiration (MVA) and misoprostol are the recommended treatment options for incomplete abortion in the first trimester, surgical management using sharp curettage is still one of the primary treatment methods in Malawi. Misoprostol and MVA are safer and cheaper, whilst sharp curettage has more risk of complications such as perforation and bleeding and requires general anesthesia and a clinician. Currently, efforts are being made to increase the use of misoprostol in the treatment of incomplete abortions in Malawi. To achieve successful implementation of misoprostol, health care providers’ perceptions on this matter are crucial. Methods: A qualitative approach was used to explore health care providers’ perceptions of misoprostol for the treatment of incomplete abortion using semi-structured in-depth interviews. Ten health care providers were interviewed at one urban public hospital. Each interview lasted 45 min on average. Health care providers of different cadres were interviewed in March and April 2021, nine months after taking part in a training intervention on the use of misoprostol. Interviews were recorded, transcribed verbatim and analyzed using ‘Systematic Text Condensation’. Results: The health care providers reported many advantages with the increased use of misoprostol, such as reduced workload, less hospitalization, fewer infections, and task-shifting. Availability of the drug and benefits for the patients were also highlighted as important. However, some challenges were revealed, such as deciding who was eligible for the drug and treatment failure. For these reasons, some health care providers still choose surgical treatment as their primary method. Conclusion: Findings in this study support the recommendation of increased use of misoprostol as a treatment for incomplete abortion in Malawi, as the health care providers interviewed see many advantages with the drug. To scale up its use, proper training and supervision are essential. A sustainable and predictable supply is needed to change clinical practice. Plain English Summary: Unsafe abortion is a major contributor to maternal mortality worldwide. Unsafe abortion is the termination of an unintended pregnancy by a person without the required skills or equipment, which might lead to serious complications. In Malawi, post-abortion complications are common, and the maternal mortality ratio is among the highest in the world. Retained products of conception, referred to as an incomplete abortion, are common after spontaneous miscarriages and unsafe induced abortions. There are several ways to treat incomplete abortion, and the drug misoprostol has been successful in the treatment of incomplete abortion in other low-income countries. This study explored perceptions among health care providers using misoprostol to treat incomplete abortions and whether the drug can be fully embraced by Malawian health care professionals. Health personnel at a Malawian hospital were interviewed individually regarding the use of the drug for treating incomplete abortions. This study revealed that health care providers interviewed are satisfied with the increased use of misoprostol. They highlighted several benefits, such as reduced workload and that it enabled task-shifting so that various hospital cadres could now treat patients with incomplete abortions. The health care workers also observed benefits for women treated with the drug compared to other treatments. The challenges mentioned were finding out who was eligible for the drug and drug failure. This study supports scaling up the use of misoprostol in the treatment of incomplete abortions in Malawi; the Ministry of Health and policymakers should support future interventions to increase its use.
- 3 December 2022
- Published by Springer Nature in BMC Health Services Research
- Vol. 22 (1) , 1-11
Open AccessHealth care providers’ perceptions of using misoprostol in the treatment of incomplete abortion in Malawi
Background: In Malawi, abortion is only legal to save a pregnant woman’s life. Treatment for complications after unsafe abortions has a massive impact on the already impoverished health care system. Even though manual vacuum aspiration (MVA) and misoprostol are the recommended treatment options for incomplete abortion in the first trimester, surgical management using sharp curettage is still one of the primary treatment methods in Malawi. Misoprostol and MVA are safer and cheaper, whilst sharp curettage has more risk of complications such as perforation and bleeding and requires general anesthesia and a clinician. Currently, efforts are being made to increase the use of misoprostol in the treatment of incomplete abortions in Malawi. To achieve successful implementation of misoprostol, health care providers’ perceptions on this matter are crucial. Methods: A qualitative approach was used to explore health care providers’ perceptions of misoprostol for the treatment of incomplete abortion using semi-structured in-depth interviews. Ten health care providers were interviewed at one urban public hospital. Each interview lasted 45 min on average. Health care providers of different cadres were interviewed in March and April 2021, nine months after taking part in a training intervention on the use of misoprostol. Interviews were recorded, transcribed verbatim and analyzed using ‘Systematic Text Condensation’. Results: The health care providers reported many advantages with the increased use of misoprostol, such as reduced workload, less hospitalization, fewer infections, and task-shifting. Availability of the drug and benefits for the patients were also highlighted as important. However, some challenges were revealed, such as deciding who was eligible for the drug and treatment failure. For these reasons, some health care providers still choose surgical treatment as their primary method. Conclusion: Findings in this study support the recommendation of increased use of misoprostol as a treatment for incomplete abortion in Malawi, as the health care providers interviewed see many advantages with the drug. To scale up its use, proper training and supervision are essential. A sustainable and predictable supply is needed to change clinical practice. Plain English Summary: Unsafe abortion is a major contributor to maternal mortality worldwide. Unsafe abortion is the termination of an unintended pregnancy by a person without the required skills or equipment, which might lead to serious complications. In Malawi, post-abortion complications are common, and the maternal mortality ratio is among the highest in the world. Retained products of conception, referred to as an incomplete abortion, are common after spontaneous miscarriages and unsafe induced abortions. There are several ways to treat incomplete abortion, and the drug misoprostol has been successful in the treatment of incomplete abortion in other low-income countries. This study explored perceptions among health care providers using misoprostol to treat incomplete abortions and whether the drug can be fully embraced by Malawian health care professionals. Health personnel at a Malawian hospital were interviewed individually regarding the use of the drug for treating incomplete abortions. This study revealed that health care providers interviewed are satisfied with the increased use of misoprostol. They highlighted several benefits, such as reduced workload and that it enabled task-shifting so that various hospital cadres could now treat patients with incomplete abortions. The health care workers also observed benefits for women treated with the drug compared to other treatments. The challenges mentioned were finding out who was eligible for the drug and drug failure. This study supports scaling up the use of misoprostol in the treatment of incomplete abortions in Malawi; the Ministry of Health and policymakers should support future interventions to increase its use.
- Open Access
- 16 October 2022
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 19 (20) , 13361
What Is the Value of a Global Health Research School for PhD Students?
The aim of the study was to investigate previous PhD students’ views on the Norwegian Research School of Global Health and its activities. Of the research schools for PhD students, few focus on global health and even fewer have evaluated the students’ perspectives of the schools. In this study, a questionnaire including quantitative and qualitative questions were sent to alumni PhD students. Demographic status was investigated, along with the alumni’s views on activities offered at the research school, suggestions for improvement, views on his or her social life as a student and as a member of the school. A total of 60 alumni were contacted by email and invited to participate in an anonymous online survey. The response rate was 65%; 90% were in employment and a few were seeking employment. All research school activities were evaluated as useful. Content analysis of qualitative questions generated three categories of the alumni’s reflections on their involvement in the research school: valued activities, challenges, and future. The alumni expressed a wish for continued contact with the school. The findings indicated that a research school for PhD students with similar interests should be continued; although modifications should be considered, based on the specific challenges revealed in the evaluation.
- 16 October 2022
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 19 (20) , 13361
Open AccessWhat Is the Value of a Global Health Research School for PhD Students?
The aim of the study was to investigate previous PhD students’ views on the Norwegian Research School of Global Health and its activities. Of the research schools for PhD students, few focus on global health and even fewer have evaluated the students’ perspectives of the schools. In this study, a questionnaire including quantitative and qualitative questions were sent to alumni PhD students. Demographic status was investigated, along with the alumni’s views on activities offered at the research school, suggestions for improvement, views on his or her social life as a student and as a member of the school. A total of 60 alumni were contacted by email and invited to participate in an anonymous online survey. The response rate was 65%; 90% were in employment and a few were seeking employment. All research school activities were evaluated as useful. Content analysis of qualitative questions generated three categories of the alumni’s reflections on their involvement in the research school: valued activities, challenges, and future. The alumni expressed a wish for continued contact with the school. The findings indicated that a research school for PhD students with similar interests should be continued; although modifications should be considered, based on the specific challenges revealed in the evaluation.
- Open Access
- 23 September 2022
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 19 (19) , 12045
Experiences of Using Misoprostol in the Management of Incomplete Abortions: A Voice of Healthcare Workers in Central Malawi
Complications after abortion are a major cause of maternal death. Incomplete abortions are common and require treatment with surgical or medical uterine evacuation. Even though misoprostol is a cheaper and safer option, it is rarely used in Malawi. To improve services, an intervention was performed to increase the use of misoprostol in post-abortion care. This study explored healthcare providers’ perceptions and experiences with misoprostol in the Malawian setting and their role in achieving effective implementation of the drug. A descriptive phenomenological study was conducted in three hospitals in central Malawi. Focus group discussions were conducted with healthcare workers in centres where the training intervention was offered. Participants were purposefully sampled, and thematic analysis was done. Most of the healthcare workers were positive about the use of misoprostol, knew how to use it and were confident in doing so. The staff preferred misoprostol to surgical treatment because it was perceived safe, effective, easy to use, cost-effective, had few complications, decreased hospital congestion, reduced workload, and saved time. Additionally, misoprostol was administered by nurses/midwives, and not just physicians, thus enhancing task-shifting. The results showed acceptability of misoprostol in post-abortion care among healthcare workers in central Malawi, and further implementation of the drug is recommended.
- 23 September 2022
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 19 (19) , 12045
Open AccessExperiences of Using Misoprostol in the Management of Incomplete Abortions: A Voice of Healthcare Workers in Central Malawi
Complications after abortion are a major cause of maternal death. Incomplete abortions are common and require treatment with surgical or medical uterine evacuation. Even though misoprostol is a cheaper and safer option, it is rarely used in Malawi. To improve services, an intervention was performed to increase the use of misoprostol in post-abortion care. This study explored healthcare providers’ perceptions and experiences with misoprostol in the Malawian setting and their role in achieving effective implementation of the drug. A descriptive phenomenological study was conducted in three hospitals in central Malawi. Focus group discussions were conducted with healthcare workers in centres where the training intervention was offered. Participants were purposefully sampled, and thematic analysis was done. Most of the healthcare workers were positive about the use of misoprostol, knew how to use it and were confident in doing so. The staff preferred misoprostol to surgical treatment because it was perceived safe, effective, easy to use, cost-effective, had few complications, decreased hospital congestion, reduced workload, and saved time. Additionally, misoprostol was administered by nurses/midwives, and not just physicians, thus enhancing task-shifting. The results showed acceptability of misoprostol in post-abortion care among healthcare workers in central Malawi, and further implementation of the drug is recommended.
- Open Access
- 28 June 2022
- Published by JMIR Publications Inc. in JMIR Preprints
Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study (Preprint)
Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. Objective: This study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings. Methods: We used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server. Results: Three iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%). Conclusions: Our smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.
- 28 June 2022
- Published by JMIR Publications Inc. in JMIR Preprints
Open AccessIterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study (Preprint)
Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. Objective: This study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings. Methods: We used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server. Results: Three iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%). Conclusions: Our smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.
- Open Access
- 13 April 2021
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 18 (8) , 4072
Women Do Not Utilise Family Planning According to Their Needs in Southern Malawi: A Cross-Sectional Survey
Malawi is a low-income country with a high maternal mortality rate. This study aimed to investigate the use of contraception and factors associated with unmet need of family planning among fertile women in selected health facilities in southern Malawi. A cross-sectional study design was employed using a validated questionnaire to investigate the unmet need. A total of 419 pregnant women, who attended antenatal clinics at a central hospital and two district hospitals, voluntarily participated in the study. Logistic regression analysis was used to identify possible factors associated with unmet needs. Amongst the participants, 15.1% reported unmet need, 27.0% had never used a contraceptive method, and 27.2% had an unwanted pregnancy. Being married, 20–24 years of age, living in a rural area, and high parity were protective factors against having unmet need regarding family planning. Malawi, a country with a young population and a high fertility rate, has a high level of unmet family planning need. Barriers and facilitators need to be identified and addressed at different levels by the health care system, society, and the government of Malawi.
- 13 April 2021
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 18 (8) , 4072
Open AccessWomen Do Not Utilise Family Planning According to Their Needs in Southern Malawi: A Cross-Sectional Survey
Malawi is a low-income country with a high maternal mortality rate. This study aimed to investigate the use of contraception and factors associated with unmet need of family planning among fertile women in selected health facilities in southern Malawi. A cross-sectional study design was employed using a validated questionnaire to investigate the unmet need. A total of 419 pregnant women, who attended antenatal clinics at a central hospital and two district hospitals, voluntarily participated in the study. Logistic regression analysis was used to identify possible factors associated with unmet needs. Amongst the participants, 15.1% reported unmet need, 27.0% had never used a contraceptive method, and 27.2% had an unwanted pregnancy. Being married, 20–24 years of age, living in a rural area, and high parity were protective factors against having unmet need regarding family planning. Malawi, a country with a young population and a high fertility rate, has a high level of unmet family planning need. Barriers and facilitators need to be identified and addressed at different levels by the health care system, society, and the government of Malawi.