Testing the feasibility of a translated and culturally adapted person-centred training programme in maternal and newborn healthcare in Democratic Republic of Congo: A process evaluation.

OBJECTIVE: Ensuring quality of maternal and newborn healthcare is challenging in the Democratic Republic of Congo (DRC) as the maternal and newborn mortality and morbidity rate is high. Essential for quality care is a person-centred approach. One model of person-centred care (PCC) has been developed at Gothenburg University. To support its implementation a training programme, "Mutual Meetings", has been developed. This study aims to test the feasibility of a translated and culturally adapted version of this PCC training programme for healthcare providers in the maternal and newborn healthcare context of DRC. METHODS: The PCC programme was translated into French and tested in a workshop with 31 maternal and newborn healthcare providers in eastern DRC. The feasibility of the programme was evaluated through focus group interviews and individual interviews. The interview transcripts were analysed deductively using key components in a process evaluation framework including fidelity, dose, reach, adaptation, acceptability, and application. RESULTS: The French PCC programme exceeded the participants' expectations and was found being applicable in both teaching and clinical setting with some suggested contextual modifications. Its pedagogic structure including a participatory reflective approach, was perceived innovative and inspirational, mediated a sense of comfort, and enabled the participants to use a person-centred approach towards each other. CONCLUSION: The results show that the French on-site version of the PCC training programme was valid in terms of feasibility and how it was received by the participants. The study demonstrates the importance of contextual adaptation of complex interventions in new settings.

'We had conversations we wouldn't have had otherwise'-Exploring home-dwelling people with dementia and family members' experiences of deliberating on ethical issues in a literature-based intervention.

AIM: To explore home-dwelling people with dementia and family members' perceptions of the feasibility and acceptability of an intervention using dementia-related literature excerpts to facilitate conversations on ethical issues related to living with dementia. BACKGROUND: Ethical issues in dementia care emerge throughout the illness. In the early stages, they may involve decisions about disclosing the illness to the family, shifting roles and responsibilities, and considerations of transitioning to a nursing home. Addressing ethical issues and providing adequate support to home-dwelling people with dementia and their families are often lacking. DESIGN: An exploratory-descriptive qualitative study. METHODS: We conducted eight interviews with 14 home-dwelling persons with dementia and their family caregivers. Six were dyadic interviews, and two were individual interviews with family caregivers. We analysed the interview data using template analysis. We adhered to the COREQ checklist in reporting this study. RESULTS: Using excerpts from dementia-related literature was a feasible and acceptable way of initiating discussions on ethical issues among home-dwelling persons with dementia and family caregivers. However, engaging the families of newly diagnosed individuals was challenging due to emotional distress. The intervention provided peer support, including identifying with others and sharing experiences. Moreover, participating couples found intimacy and relational attunement through shared reflections. CONCLUSION: Based on the findings, it appears that the participants in this study felt that using excerpts from dementia-related literature to deliberate on ethical issues was feasible and acceptable. Deliberating on ethical issues with peers and family caregivers offers valuable social support and opportunities for strengthening relationships. IMPLICATIONS FOR PATIENT CARE: This study makes an important contribution by providing valuable insights into how ethical issues related to living with dementia can be addressed using related literature and suggests how the intervention can be integrated into existing care initiatives for home-dwelling people with dementia and their families. REPORTING METHOD: We have adhered to relevant EQUATOR guidelines with the COREQ reporting method. PATIENT OR PUBLIC CONTRIBUTION: A healthcare professional working as a so-called dementia coordinator (a title used in the Danish context) was involved in the conduct of this study by being responsible for the recruitment of home-dwelling people with dementia and their family members. Moreover, she had joint responsibility for facilitating the intervention along with the first author.

Implementing a new birthing room design: a qualitative study with a care provider perspective.

BACKGROUND: Research shows that interventions to protect the sensitive physiological process of birth by improving the birthing room design may positively affect perinatal outcomes. It is, however, crucial to understand the mechanisms and contextual elements that influence the outcomes of such complex interventions. Hence, we aimed to explore care providers' experiences of the implementation of a new hospital birthing room designed to be more supportive of women's birth physiology. METHODS: This qualitative study reports on the implementation of the new birthing room, which was evaluated in the Room4Birth randomised controlled trial in Sweden. Individual interviews were undertaken with care providers, including assistant nurses, midwives, obstetricians, and managers (n = 21). A content analysis of interview data was conducted and mapped into the three domains of the Normalisation Process Theory coding manual: implementation context, mechanism, and outcome. RESULTS: The implementation of the new room challenged the prevailing biomedical paradigm within the labour ward context and raised the care providers' awareness about the complex interplay between birth physiology and the environment. This awareness had the potential to encourage care providers to be more emotionally present, rather than to focus on monitoring practices. The new room also evoked a sense of insecurity due to its unfamiliar design, which acted as a barrier to integrating the room as a well-functioning part of everyday care practice. CONCLUSION: Our findings highlight the disparity that existed between what care providers considered valuable for women during childbirth and their own requirements from the built environment based on their professional responsibilities. This identified disparity emphasises the importance of hospital birthing rooms (i) supporting women's emotions and birth physiology and (ii) being standardised to meet care providers' requirements for a functional work environment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03948815, 14/05/2019.

Contextual factors influencing implementation of a university-based midwifery education programme in Central Africa: A qualitative study.

AIM: To investigate contextual factors and their influence on implementing a 90-credit midwifery education programme for nurses at a university in the eastern DRC. BACKGROUND: To improve maternal and neonatal health, there is a government policy in the Democratic Republic of Congo (DRC) to educate midwives at a higher education level according to international norms. This study investigates contextual factors and their influence on the implementation of a midwifery education programme which is based on national curriculum and has a profile of person-centred care, simulation-based learning pedagogy and information and communication technology. METHOD: A qualitative study was conducted with data collected through semi-structured interviews with 22 participants who were directly or indirectly involved in establishing the midwifery education programme. Transcribed interviews were analysed using content analysis. RESULTS: The factors influencing the implementation of the new midwifery education programme comprise facilitating and hindering factors. Facilitating factors were: (i) awareness that midwives educated at a higher education level can deliver higher-quality health care, (ii) women are motivated to seek care from well-educated midwives, (iii) the planned programme is attractive and (iv) the university has a stable academic administration and established collaborations. Hindering factors were: (i) Students' lack of prerequisites for study; (ii) objections to educating midwives at a higher education level; (iii) inadequate teaching resources; and (iv) inadequate working conditions for midwives. CONCLUSION: The facilitating factors strengthen the belief that it is possible to implement this midwifery education programme, while the hindering factors need to be addressed to run the programme successfully. The findings can guide higher education institutions starting similar midwifery education programmes in the DRC and elsewhere, although it is crucial to conduct a context study in those specific contexts.

The Birth Companions' Experience of the Birthing Room and How It Influences the Supportive Role: A Qualitative Study.

AIM: To explore birth companions' experience of the birthing room and how it influences their role supporting the woman during labor and birth. BACKGROUND: Although support from a birth companion positively affects the outcome of labor and birth, limited research explores how the birthing room influences the companion. This study identifies elements of the birthing room essential for the birth companion to offer optimal support to the woman during labor and birth. METHODS: Fifteen birth companions were individually interviewed 2 weeks to 6 months after birth using a semi-structured interview guide. Transcribed interviews were analyzed based on reflexive thematic analysis. RESULTS: The findings are captured by one overall theme: creating a supportive birth space in an unfamiliar environment. This creation process is further described by three subthemes: not being in the way, finding one's role, and being close to the birthing woman. CONCLUSIONS: The findings illustrate how the birthing room was an unfamiliar environment for the birth companions, but one that they needed in order to give the required support. With slight changes in physical design, the birthing room can become calmer and more private and better help the birth companion fulfill the supportive role.

Using process-oriented groups reflections with health care providers to improve childbirth care in the Democratic Republic of Congo - An implementation study.

OBJECTIVE: The ability to systematically reflect on care during labour and birth needs to be developed among health care providers. This study investigates the experiences of health care providers who have participated in process-oriented group reflections. The activity of group reflections was one of the three pillars of a training intervention seeking to implement evidence-based care routines during labour and birth that could contribute to reduced mortality and improved maternal and newborn health in the Democratic Republic of Congo (DRC). METHODS: Using a qualitative approach, we interviewed 131 health care providers, in focus groups (n = 19) and individually (n = 2). Analysis of transcribed interviews was conducted using qualitative content analysis according to Elo and Kyngäs. RESULTS: Group reflections added essential knowledge to the other components of the three-pillar training intervention. Through sharing and analysing care situations health care providers got increased self-awareness, tools to achieve structured and safe care routines, and to practice teamworking. CONCLUSION: Using a structured model of process-oriented group reflection for health care providers on care during labour and birth proved to be a vital aspect of the training intervention, as it added knowledge to the skills gained through theoretical and simulation-based education. The three-pillar training intervention improved care routines that supported healthy births and management of complications. We recommend that structured and secure group reflections be included in similar training activities in the DRC and elsewhere, and assessed in further studies.

Impact of Birthing Room Design on Maternal Childbirth Experience: Results From the Room4Birth Randomized Trial.

OBJECTIVE: To study the effect of the birthing room design on nulliparous women's childbirth experience up to 1 year after birth. BACKGROUND: Although it is known that the birth environment can support or hinder birth processes, the impact of the birthing room design on maternal childbirth experience over time is insufficiently studied. METHODS: The Room4Birth randomized controlled trial was conducted at a labor ward in Sweden. Nulliparous women in active stage of spontaneous labor were randomized (n = 406) to either a regular birthing room (n = 202) or a new birthing room designed with more person-centered considerations (n = 204). Childbirth experiences were measured 2 hr, 3 months, and 12 months after birth by using a Visual Analogue Scale of Overall Childbirth Experience (VAS-OCE), the Fear of Birth Scale (FOBS), and the Childbirth Experience Questionnaire (CEQ2). RESULTS: Women randomized to the new room had a more positive childbirth experience reported on the VAS-OCE 3 months (p = .002) and 12 months (p = .021) after birth compared to women randomized to a regular room. Women in the new room also scored higher in the total CEQ2 score (p = .039) and within the CEQ2 subdomain own capacity after 3 months (p = .028). The remaining CEQ2 domains and the FOBS scores did not differ between the groups. CONCLUSIONS: These findings show that a birthing room offering more possibilities to change features and functions in the room according to personal needs and requirements, positively affects the childbirth experience of nulliparous women 3 and 12 months after they have given birth.

The midwife's role in achieving the Sustainable Development Goals: protect and invest together - the Swedish example.

'The midwife's role in achieving the Sustainable Development Goals: Protect and Invest Together' is a report providing the reader the opportunity for understanding and appreciating the history of midwifery in Sweden and the interlinked nature of the United Nation's SDGs supporting health and wellbeing of women and children. To realise the opportunity to have a country with well-educated midwives of high academic standard, and, at the same time, promoting gender equality and equity we need to protect and invest together in midwives. This paper provides the foundation for a revitalised discussion on midwives' role for women and child health in the 21st century. The full Swedish Midwifery report was published in October 2021.

Room4Birth - The effect of giving birth in a hospital birthing room designed with person-centred considerations: A Swedish randomised controlled trial.

OBJECTIVE: To evaluate if a birthing room designed with person-centred considerations improves labour and birth outcomes for nulliparous women when compared to regular birthing rooms. METHODS: A randomised controlled trial was conducted at a Swedish labour ward between January 2019 and October 2020. Nulliparous women in spontaneous labour were randomised either to a birthing room designed with person-centred considerations (New room) or a Regular room. The primary outcome was a composite of four variables: vaginal non-instrumental birth; no oxytocin augmentation; postpartum blood loss < 1000 ml; and a positive childbirth experience. To detect a difference of 8% between the groups, 1274 study participants were needed, but the trial was terminated early due to consequences of the Covid-19 pandemic. RESULTS: A total of 406 women were randomised; 204 to the New room and 202 to the Regular room. There was no significant difference in the primary outcome between the groups (42.2% versus 35.1%; odds ratio: 1.35, 95% Confidence Interval 0.90-2.01; p = 0.18). Participants in the New room used epidural analgesia to a lower extent (54.4% versus 65.3%, relative risk: 0.83, 95% Confidence Interval 0.71-0.98; p = 0.03) and reported to a higher degree that the room contributed to a sense of safety, control, and integrity (p=<0.001). CONCLUSIONS: The hypothesis that the New room would improve the primary outcome could not be verified. Considering the early discontinuation of the study, results should be interpreted with caution. Nevertheless, analyses of our secondary outcomes emphasise the experiential value of the built birth environment in improving care for labouring women.

Sexual satisfaction and its associations with patient-reported outcomes in a cohort of women living with human immunodeficiency virus in Sweden.

Background: Sexual satisfaction is an important dimension of health-related quality of life that needs to be addressed. Various factors may influence sexual satisfaction in women living with HIV (WLHIV); however, research in this area is limited. The aim of this study was to investigate patients' self-reported sexual satisfaction and its associations with patient-reported outcomes in WLHIV in Sweden. Methods: Data was retrieved from the InfCareHIV registry for the years 2011-2016. The registry includes a self-reported validated 9-item health questionnaire to assess patient-reported outcomes, side effects and adherence. In total, 1292 WLHIV aged ≥18 years were included, corresponding to 42.8% of the female Swedish InfCareHIV cohort 2011-2016. A total of 2444 questionnaires were included in the study. The patient-reported outcomes used were satisfaction with physical health and psychological health, sexual satisfaction, and experiencing side effects from HIV-medication. Associations were tested in univariable and multivariable models. Results: The study shows that there was a significant association between sexual satisfaction and satisfaction with psychological health (p ≤ 0.0001). There was a lower probability of reporting sexual satisfaction in women who were of an older age when they received an HIV-diagnosis (p = 0.033), who had lived for more years with HIV (p = 0.0004), or who had experienced side effects (p = 0.028). Conclusions: This national register-based study identified that sexual satisfaction in WLHIV is associated with psychological health and with having experienced side-effects. Patient-reported outcomes can provide valuable information so that the care of WLHIV covers all aspects of health and supports sexual satisfaction, which is an important part of quality of life.

Implementation of a midwifery model of woman-centered care in practice: Impact on oxytocin use and childbirth experiences.

INTRODUCTION: Theoretical models for midwifery have been developed in different countries, but few have been evaluated. This study evaluated the implementation of a midwifery model of woman-centered care (MiMo) in practice. METHODS: A mixed method study based on an implementation of MiMo was carried out in a labor ward at a university hospital in Sweden, with another labor ward as a reference. The qualitative core component was a secondary analysis of focus groups with midwives after the implementation. The supplemental quantitative components were oxytocin use for augmentation of labor and women's childbirth experiences before and after the implementation. RESULTS: The midwives viewed MiMo as a useful tool for comprehending the birthing woman holistically, and for identifying what might disturb the birth process. Hindering factors were a lack of organizational stability and time, and midwives' unwillingness to understand the model. Oxytocin use decreased significantly only in the implementation ward (p=0.002) and a significant difference was found between wards in the post-implementation period (p=0.004). However, logistic regression analyses showed that the interaction between ward and time period, controlling for age, epidural use, and birth outcome, was not significant (p=0.304), indicating that the decrease was not significantly related to the implementation. Childbirth experience did not differ before and after the implementation. CONCLUSIONS: By using MiMo in practice, midwives have a tool for comprehending the woman holistically and identifying disturbing factors during the birth. However, more research is needed for further implementation that should focus on the potential as well as hindering factors.

Women's Experiences of Physical Features in a Specially Designed Birthing Room: A Mixed-Methods Study in Sweden.

AIM: To explore women's experiences of physical features in a birthing room designed to be adaptable to personal wishes and needs during labor and birth. BACKGROUND: Childbirth is a central life event influenced by numerous factors, including the healthcare environment; however, there is insufficient knowledge on how the physical design affects women during birth. METHODS: This study was part of a randomized controlled trial in the Room4Birth research project, including women randomized to receive care in a new birthing room designed with physical features changeable according to personal wishes. Data consisted of responses to two questions analyzed with descriptive statistics (n = 202) and semi-structured interviews analyzed for content (n = 19). RESULTS: A total of 93.6% (n = 189) assessed the physical features in the birthing room as meaningful to a very high or high extent. The overall impression of the room was positive and exceeded women's expectations. They felt welcomed and strengthened by the room, which shifted the focus to a more positive emotional state. The room differed from traditional hospital birthing rooms, contained familiar features that maintained integrity, and had space for companions. The variety of physical features was appreciated. Of nine listed physical features, the bathtub was ranked most important, followed by the projection of nature scenery, and dimmable lighting, but the room as a whole appeared most important. CONCLUSIONS: When planning and designing hospital-based birthing rooms, it is crucial to offer possibilities to adapt the room and physical features according to personal wishes.

A Lifestyle Intervention During Pregnancy and Its Effects on Child Weight 2.5 Years Later.

AIM: The aim of this study was to evaluate if overweight and obesity in the offspring is reduced by a low-intensity antenatal primary care intervention with focus on diet and physical activity for pregnant women with obesity, comparing children to mothers receiving the intervention with children to mothers who did not. METHODS: This study is a follow-up of children 2.5 years of age after their mothers' participation in a non-randomised controlled intervention intending to limit gestational weight gain. All study participants received standard antenatal care. The intervention group received lifestyle support via motivational talks with midwife and support from dietician. Data on child weight were collected by medical records, letter and phone. RESULTS: There was no significant difference between the groups 2.5 years after intervention (International Obesity Task Force ISO-BMI 25 (child BMI corresponding to adult BMI of 25): 20% vs. 21%; ISO-BMI 30: 4.6% vs. 1.3%). The mother's BMI at the beginning of pregnancy significantly influenced child BMI at 2.5 years (r = 0.13, p = 0.014, r2 = 0.017). For each unit of increase in maternal BMI at enrollment, the probability of child ISO-BMI ≥ 25 increased by 7.5% (p = 0.021) and of ≥ 30, by 12.9% (p = 0.017). CONCLUSION: The frequency of overweight and obesity of the children at 2.5 years of age was significantly correlated to the mother's BMI, but not correlated to the mothers' participation in the antenatal lifestyle intervention. Thus, it seems important to address obesity and lifestyle issues before and between pregnancies. Trial registration The study has been registered at ClinicalTrials.gov, Identifier: NCT03147079.

Implementation of a three-pillar training intervention to improve maternal and neonatal healthcare in the Democratic Republic Of Congo: a process evaluation study in an urban health zone.

BACKGROUND: Numerous quality-improvement projects including healthcare professional training are conducted globally every year, but there is a gap between the knowledge obtained in the training and its implementation in practice and policy. A quality-improvement programme was conducted in eastern Democratic Republic of Congo (DRC) to reduce maternal and neonatal mortality and morbidity. OBJECTIVE: This study explores the implementation process, mechanisms of impact, and outcomes of a training intervention addressing labour and birth management and involving healthcare providers in an urban health zone in eastern part of DRC. METHODS: In 2019, master trainers were educated and in turn trained facilitators from seven participating healthcare facilities, which received the necessary equipment. Data comprised statistics on maternal and neonatal birth outcomes for the years before and after the training intervention, and focus group discussions (n = 18); and interviews (n = 2) with healthcare professionals, at the end of (n = 52) and after the training intervention (n = 59), respectively. The analysis was guided by a process evaluation framework, using descriptive statistics and content analysis. RESULTS: The three-pillar training intervention using a low-dose, high-frequency approach was successfully implemented in terms of fidelity, dose, adaptation, and reach. Several improved care routines were established, including improved planning, teamwork, and self-reflection skills, as well as improved awareness of the influence of the care environment, of having a respectful encounter, and of allowing a companion to be present with the birthing woman. The proportions of emergency caesareans decreased and of vaginal births increased without an increase in maternal and neonatal complications. CONCLUSION: The findings of this study are encouraging and provide learnings for other healthcare facilities in DRC as well as other low-income countries. When designing similar training interventions, it is crucial to consider contextual factors such as incentives and to measure more salutogenic outcomes.

People living with HIV in Sweden report high levels of sexual satisfaction in a registry-based cohort study.

Sexual satisfaction can be challenging for people living with HIV (PLWH). To investigate self-reported sexual satisfaction in PLWH and its association with HIV-related biomarkers, a retrospective observational cohort study with data on sociodemographic characteristics and changes in PLWH's assessment of their sexual satisfaction over time were retrieved from the Swedish National Quality Assurance Registry (InfCareHIV) where patient-related outcomes are reported annually. PLWH who had assessed self-reported sexual satisfaction 2011-2016 were included. Sexual satisfaction was dichotomized into sexual "satisfaction and dissatisfaction" and associations were analysed. In total, 3798 patients (66% men) answered 8202 questionnaires. Overall, 67% reported sexual satisfaction, with women more satisfied than men (72% vs 64%, p < 0.0001). Sexual satisfaction did not differ between patients on antiretroviral treatment (ART) >6 months whether the viral load was suppressed or not. Overall, the probability of reporting sexual satisfaction increased by 4% annually (p < 0.001). This increase may be explained by evolving knowledge about the minimal risks of sexual HIV transmission when on ART together with Sweden's concomitant revision of legal restrictions. The use of patient-related outcomes in clinical practice is an important tool for facilitating conversations about sexuality in order to promote the health and well-being of PLWH.

The influence and meaning of the birth environment for nulliparous women at a hospital-based labour ward in Sweden: An ethnographic study.

BACKGROUND: Labour and birth are sensitive physiological processes substantially influenced by environmental and psychosocial factors. AIM: To explore the influence and meaning of the birth environment for nulliparous women giving birth in either one of two differently designed birthing rooms at a hospital-based labour ward. METHODS: Five months of ethnographic fieldwork was conducted at a labour ward in Sweden, consisting of participant observations of 16 nulliparous women giving birth in either a 'Regular' birthing room (n = 8) or a specially designed, 'New room' (n = 8). Data included field notes, informal interviews, reflective notes, and individual interviews with eight women after birth. The data was analysed through an ethnographic iterative hermeneutic analysis process. FINDINGS: The analysis identified the birth environment as consisting of the physical space, the human interaction within it, and the institutional context. The analytic concept; Birth Manual was conceived as an instrument for managing labour in accordance with institutional authority. Significant to the interpretation of the influence and meaning of the birth environment were two abstract rooms: an Institutional room, where birth was approached as a critical event, designating birthing women as passive; and a Personal room, where birth was approached as a physiological event in which women's agency was facilitated. CONCLUSION: Institutional authority permeated the atmosphere within the birth environment, irrespective of the design of the room. A power imbalance between institutional demands and birthing women's needs was identified, emphasising the vital role the birth philosophy plays in creating safe birth environments that increase women's sense of agency.

Contextual factors influencing a training intervention aimed at improved maternal and newborn healthcare in a health zone of the Democratic Republic of Congo.

BACKGROUND: Maternal and neonatal mortality and morbidity in the Democratic Republic of Congo (DRC) are among the highest worldwide. As part of a quality improvement programme in a health zone in the DRC aimed at contributing to reduced maternal and neonatal mortality and morbidity, a three-pillar training intervention around childbirth was developed and implemented in collaboration between Swedish and Congolese researchers and healthcare professionals. The aim of this study is to explore contextual factors influencing this intervention. METHODS: A qualitative research design was used, with data collected through focus group discussions (n = 7) with healthcare professionals involved in the intervention before and at the end (n = 9). Transcribed discussions were inductively analysed using content analysis. RESULTS: Three generic categories describe the contextual factors influencing the intervention: i) Incentives motivated participants' efforts to begin a training programme; ii) Involving the local health authorities was important; and (iii) Having physical space, electricity, and equipment in place was crucial. CONCLUSIONS: This study and similar ones highlight that incentives of various types are crucial contextual factors that influence training interventions, and have to be considered already in the planning of such interventions. One such factor is expectations of monetary incentives. To meet this in a small research project like ours would require a reduction of the scale and thus limit the implementation of new evidence-based knowledge into practice aimed at reducing maternal mortality and morbidity.

Cost effectiveness of a controlled lifestyle intervention for pregnant women with obesity.

BACKGROUND: The Mighty Mums antenatal lifestyle intervention is a person-centered behavioral intervention focusing on nutrition and physical activity for pregnant women with obesity (body mass index [BMI] ≥30). The aim of this study was to evaluate the costs and clinical outcomes of adding the Mighty Mums intervention to standard antenatal care. METHODS: Participants in the intervention group (n = 434) received motivational talks with their midwife and a selection of physical and/or nutritional activities in addition to antenatal care. Control participants (n = 867) from adjacent geographic areas received standard antenatal care. Costs for staff, unit costs for specific activities, and registered costs for specialized antenatal care were analyzed for associations with gestational weight gain and self-reported health. Results are reported for the intention-to-treat (ITT) population and a per protocol (PP) population identified by participation in the intervention. Analyses included bootstrapped linear regressions adjusted for background characteristics that differed significantly between groups. RESULTS: The average costs were SEK 9727 higher (95% confidence interval [CI]: 6677 to 12,777) among participants in the intervention group than in the control ITT population and SEK 8655 (95% CI 4586 to 12,724) higher than in the PP population. The cost increase per 1 kg reduction in gestational weight gain was SEK 12,369 in the ITT population and SEK 7209 for the PP population. CONCLUSION: Participation in the Mighty Mums intervention was associated with higher costs, but also reduced gestational weight gain. The cost per kilogram reduction in gestational weight gain was low, particularly in the PP population. A future decision to implement this behavioral intervention in standard care should take into account society's willingness to pay per unit reduction in gestational weight gain. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov , Identifier: NCT03147079 .

Medical cannabis and cannabis-based medicine show both potential efficacy and potential harms: Cross-sectional comparison with controls on self-rated and interviewer-rated outcomes within the Danish pilot program on medical cannabis.

BACKGROUND AND PURPOSE: Denmark launched a pilot program of medical cannabis in January 2018. The aim was to establish whether medical cannabis and cannabis-based medicine (MC/CBM) were superior and safe compared to conventional treatment, regardless of the indications for which people received such medication. MATERIALS AND METHODS: People (cases) were identified who had redeemed at least one prescription of MC/CBM according to the nationwide, unselected Danish registers. These were propensity-score matched to controls with the same indications who had not used MC/CBM. Potential participants were contacted electronically, and if willing to participate filled in various survey instruments online. Participants were also interviewed in person in order to investigate symptoms of depression, anxiety, and to assess cognitive levels. Different sets of analyses were conducted, handling potential confounders in different ways. RESULTS: In the primary analyses, cases were more satisfied with their treatment than were controls (mean (SD) 29.2 (4.8) versus 26.5 (4.5) on the CSQ, p = 0.006), and scored lower on depression (3.3 (3.0) versus 4.6 (2.9), p = 0.03). Cases reported higher levels of pain than controls when measured on the SF-36 bodily-pain subdomain (36.3 (23.0) versus 48.7 (30.1), p = 0.01). There were indications of worse symptoms of multiple sclerosis in cases compared to controls. Reported side-effects were generally mild. CONCLUSION: Both potential effects and harms of MC/CBM were observed. Randomized trials are required to establish if these are true effects and harms, or due to confounding by indication.