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.

Fast-track program of elective joint replacement in hip and knee-patients' experiences of the clinical pathway and care process.

BACKGROUND: The clinical pathway and care program in elective total hip and knee replacement (THR/TKR) has, during the last decade, undergone considerable changes in many countries influenced by the concept of fast-track surgery, resulting in a very short hospital stay. Studies into patients' experiences of the entire fast-track program, from decision-making regarding surgery until recovery 3 months after surgery, are lacking. The aim of the study was to increase the knowledge about patients' experiences of the clinical pathway and care in a fast-track program of elective THR/TKR in order to identify factors that may influence recovery and clinical outcome. METHODS: A qualitative research design was chosen with data collected from interviews 3 months after surgery and analyzed using an inductive content analysis method. In total, 24 patients from three hospitals with a fast-track care program were included in the study: 14 women and 10 men, 13 with THR and 11 with TKR. The mean age was 65 years (range 44-85). RESULTS: The analysis identified three chronological phases in the clinical pathway: preparation, hospital stay for surgery, and recovery. In the preparation phase, patients' experiences and involvement in the planning of the operation were highlighted. The need to know the risks and expectations of recovery and outcome were also central, although there was great diversity in needs for information and involvement. In the hospital stay for the surgery phase, there were mainly positive experiences regarding admission, early mobilization, and early discharge. Experiences about the recovery phase focused on management of daily life, rehabilitation program, and recovery. Rehabilitation involved uncertainty as to whether or not the progress was normal. The recovery phase was also filled with questions about unfulfilled expectations. Regardless of the different phases, we found the importance of a person-centered care to be a pervasive theme. CONCLUSION: Our study supports the view that a person-centered approach, from surgery decision until recovery, is an important element in optimizing care in a THR and TKR fast-track care program. More focus on the period after hospital discharge may improve recovery, patient satisfaction, and functional outcome.

Maternal probiotic supplementation for prevention of morbidity and mortality in preterm infants.

BACKGROUND: Inflammation may contribute to preterm birth and to morbidity of preterm infants. Preterm infants are at risk for alterations in the normal protective microbiome. Oral probiotics administered directly to preterm infants have been shown to decrease the risk for severe necrotizing enterocolitis (NEC) as well as the risk of death, but there are safety concerns about administration of probiotics directly to preterm infants. Through decreasing maternal inflammation, probiotics may play a role in preventing preterm birth and/or decreasing the inflammatory milieu surrounding delivery of preterm infants, and may alter the microbiome of the preterm infant when given to mothers during pregnancy. Probiotics given to mothers after birth of preterm infants may effect infant bacterial colonization, which could potentially reduce the incidence of NEC. OBJECTIVES: 1. To compare the efficacy of maternal probiotic administration versus placebo or no intervention in mothers during pregnancy for the prevention of preterm birth and the prevention of morbidity and mortality of infants born preterm.2. To compare the efficacy of maternal probiotic administration versus placebo, no intervention, or neonatal probiotic administration in mothers of preterm infants after birth on the prevention of mortality and preterm infant morbidities such as NEC. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 2), MEDLINE via PubMed (1966 to 21 March 2017), Embase (1980 to 21 March 2017), and CINAHL (1982 to 21 March 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. SELECTION CRITERIA: We included randomized controlled trials in the review if they administered oral probiotics to pregnant mothers at risk for preterm birth, or to mothers of preterm infants after birth. Quasi-randomized trials were eligible for inclusion, but none were identified. Studies enrolling pregnant women needed to administer probiotics at < 36 weeks' gestation until the trimester of birth. Probiotics considered were of the genera Lactobacillus, Bifidobacterium or Saccharomyces. DATA COLLECTION AND ANALYSIS: We used the standard methods of the Cochrane Collaboration and Cochrane Neonatal to determine the methodologic quality of studies, and for data collection and analysis. MAIN RESULTS: We included 12 eligible trials with a total of 1450 mothers and 1204 known infants. Eleven trials administered probiotics to mothers during pregnancy and one trial administered probiotics to mothers after birth of their preterm infants. No studies compared maternal probiotic administration directly with neonatal administration. Included prenatal trials were highly variable in the indication for the trial, the gestational age and duration of administration of probiotics, as well as the dose and formulation of the probiotics. The pregnant women included in these trials were overall at low risk for preterm birth. In a meta-analysis of trial data, oral probiotic administration to pregnant women did not reduce the incidence of preterm birth < 37 weeks (typical risk ratio (RR) 0.92, 95% confidence interval (CI) 0.32 to 2.67; 4 studies, 518 mothers and 506 infants), < 34 weeks (typical risk difference (RD) 0.00, 95% CI -0.02 to 0.02; 2 studies, 287 mothers and infants), the incidence of infant mortality (typical RD 0.00, 95% CI -0.02 to 0.02; 2 studies, 309 mothers and 298 infants), or the gestational age at birth (mean difference (MD) 0.15, 95% CI -0.33 to 0.63; 2 studies, 209 mothers with 207 infants).One trial studied administration of probiotics to mothers after preterm birth and included 49 mothers and 58 infants. There were no significant differences in the risk of any NEC (RR 0.44, 95% CI 0.13 to 1.46; 1 study, 58 infants), surgery for NEC (RR 0.15, 95% CI 0.01 to 2.58; 1 study, 58 infants), death (RR 0.66, 95% CI 0.06 to 6.88; 1 study, 58 infants), and death or NEC (RR 0.53, 95% CI 0.19 to 1.49; 1 study, 58 infants). There was an improvement in time to reach 50% enteral feeds in infants whose mothers received probiotics, but the estimate is imprecise (MD -9.60 days, 95% CI -19.04 to -0.16 days; 58 infants). No other improvement in any neonatal outcomes were reported. The estimates were imprecise and do not exclude the possibility of meaningful harms or benefits from maternal probiotic administration. There were no cases of culture-proven sepsis with the probiotic organism. The GRADE quality of evidence was judged to be low to very low due to inconsistency and imprecision. AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude whether there is appreciable benefit or harm to neonates of either oral supplementation of probiotics administered to pregnant women at low risk for preterm birth or oral supplementation of probiotics to mothers of preterm infants after birth. Oral supplementation of probiotics to mothers of preterm infants after birth may decrease time to 50% enteral feeds, however, this estimate is extremely imprecise. More research is needed for post-natal administration of probiotics to mothers of preterm infants, as well as to pregnant mothers at high risk for preterm birth.

Routine interventions in childbirth before and after initiation of an Action Research project.

BACKGROUND: Unnecessary routine interventions in uncomplicated labour and birth, like cardiotocography (CTG), amniotomy, use of scalp electrode and oxytocin treatment, are associated with further interventions that could harm the woman and the infant. A four year Action Research (AR) project was done on a labour ward to enhance the capacity of local midwives in the promotion of physiological labour and birth. AIM: To describe the use of interventions during labour and birth in healthy women at term with spontaneous onset of labour, before and after initiation of an Action Research project. METHODS: A retrospective before and after comparative study of clinical records from 2009 (before) and 2012 (after), based on a random selection of records from primiparous and multiparous women. Outcome measures were duration of admission CTG, frequency of admission CTG over 30min, frequency of amniotomy, use of scalp electrode, and frequency of oxytocin augmentation in spontaneous labour. RESULTS: 903 records were included. The duration of admission CTG (p=0.001), frequency of admission CTG duration over 30min (p=<0.001), the use of scalp electrodes (p=<0.001), and use of oxytocin augmentation of spontaneous labour (p=0.014) were reduced significantly after initiation of the AR project. There were no significant differences in frequency of amniotomy, duration of total CTG, postpartum bleeding, sphincter tears, Apgar score <5 at 5min, and mode of birth. CONCLUSION: Following an AR project, several interventions were reduced during labour and birth. Controlled studies in other settings are needed to assess the impact of collaborative action on decreasing unnecessary interventions.

Adopting a healthy lifestyle when pregnant and obese - an interview study three years after childbirth.

BACKGROUND: Obesity during pregnancy is increasing and is related to life-threatening and ill-health conditions in both mother and child. Initiating and maintaining a healthy lifestyle when pregnant with body mass index (BMI) ≥ 30 kg/m(2) can improve health and decrease risks during pregnancy and of long-term illness for the mother and the child. To minimise gestational weight gain women with BMI ≥ 30 kg/m(2) in early pregnancy were invited to a lifestyle intervention including advice and support on diet and physical activity in Gothenburg, Sweden. The aim of this study was to explore the experiences of women with BMI ≥ 30 kg/m(2) regarding minimising their gestational weight gain, and to assess how health professionals' care approaches are reflected in the women's narratives. METHODS: Semi-structured interviews were conducted with 17 women who had participated in a lifestyle intervention for women with BMI ≥ 30 kg/m(2) during pregnancy 3 years earlier. The interviews were digitally recorded and transcribed in full. Thematic analysis was used. RESULTS: The meaning of changing lifestyle for minimising weight gain and of the professional's care approaches is described in four themes: the child as the main motivation for making healthy changes; a need to be seen and supported on own terms to establish healthy routines; being able to manage healthy activities and own weight; and need for additional support to maintain a healthy lifestyle. CONCLUSIONS: To support women with BMI ≥ 30 kg/m(2) to make healthy lifestyle changes and limit weight gain during pregnancy antenatal health care providers should 1) address women's weight in a non-judgmental way using BMI, and provide accurate and appropriate information about the benefits of limited gestational weight gain; 2) support the woman on her own terms in a collaborative relationship with the midwife; 3) work in partnership to give the woman the tools to self-manage healthy activities and 4) give continued personal support and monitoring to maintain healthy eating and regular physical activity habits after childbirth involving also the partner and family.

Role of Theories in the Design of Web-Based Person-Centered Support: A Critical Analysis.

Objective. The aim of this study was to provide a critical understanding of the role of theories and their compatibility with a person-centered approach in the design and evaluation of web-based support for the management of chronic illness. Methods. Exploration of web-based support research projects focusing on four cases: (1) preschool children aged 4-6 with bladder dysfunction and urogenital malformation; (2) young adults aged 16-25 living with mental illness; (3) women with type 1 diabetes who are pregnant or in early motherhood; and (4) women who have undergone surgery for breast cancer. Data comprised interviews with research leaders and documented plans. Analysis was performed by means of a cross-case methodology. Results. The used theories concerned design, learning, health and well-being, or transition. All web support products had been developed using a participatory design (PD). Fundamental to the technology design and evaluation of outcomes were theories focusing on learning and on health and well-being. All theories were compatible with a person-centered approach. However, a notable exception was the relatively collective character of PD and Communities of Practice. Conclusion. Our results illustrate multifaceted ways for theories to be used in the design and evaluation of web-based support.

Predicting risk of coronary events and all-cause mortality: role of B-type natriuretic peptide above traditional risk factors and coronary artery calcium scoring in the general population: the Heinz Nixdorf Recall Study.

AIMS: Several biomarkers including B-type natriuretic peptide (BNP) have been suggested to improve prediction of coronary events and all-cause mortality. Moreover, coronary artery calcium (CAC) as marker of subclinical atherosclerosis is a strong predictor for cardiovascular mortality and morbidity. We aimed to evaluate the predictive ability of BNP and CAC for all-cause mortality and coronary events above traditional cardiovascular risk factors (TRF) in the general population. METHODS: We followed 3782 participants of the population-based Heinz Nixdorf Recall cohort study without coronary artery disease at baseline for 7.3 ± 1.3 years. Associations of BNP and CAC with incident coronary events and all-cause mortality were assessed using Cox regression, Harrell's c, and time-dependent integrated discrimination improvement (IDI(t), increase in explained variance). RESULTS: Subjects with high BNP levels had increased frequency of coronary events and death (coronary events/mortality: 14.1/28.2% for BNP ≥100 pg/ml vs. 2.7/5.5% for BNP < 100 pg/ml, respectively). Subjects with a BNP ≥100 pg/ml had increased incidence of hard endpoints sustaining adjustment for CAC and TRF (for coronary events: hazard ratio (HR) (95% confidence interval (CI)) 3.41(1.78-6.53); for all-cause mortality: HR 3.35(2.15-5.23)). Adding BNP to TRF and CAC increased measures of predictive ability: coronary events (Harrell's c, for coronary events, 0.775-0.784, p = 0.09; for all-cause mortality 0.733-0.740, p = 0.04; and IDI(t) (95% CI), for coronary events: 2.79% (0.33-5.65%) and for all-cause mortality 1.78% (0.73-3.10%). CONCLUSIONS: Elevated levels of BNP are associated with excess incident coronary events and all-cause mortality rates, with BNP and CAC significantly and complementary improving prediction of risk in the general population above TRF.

Coronary artery calcification outperforms thoracic aortic calcification for the prediction of myocardial infarction and all-cause mortality: the Heinz Nixdorf Recall Study.

BACKGROUND: Thoracic aortic calcification (TAC) is associated with cardiovascular (CV) risk factors and prevalent coronary artery disease. We aimed to investigate whether TAC burden is associated with incident myocardial infarction (MI) and all-cause mortality in subjects without known coronary artery disease and to determine its predictive value for these endpoints. METHODS: We used longitudinal data from the population-based prospective Heinz Nixdorf Recall Study. TAC and coronary artery calcification (CAC) scores were quantified from non-contrast enhanced electron beam computed tomography. Cox regression analysis was used to determine the association of TAC with incident MI or all-cause mortality, adjusting for CV risk factors and additionally for CAC-score in a separate step. Predictive value of TAC was assessed using Harrell's C index. RESULTS: Overall, 4040 participants without known coronary artery disease (59.4 years, 47% male) were included in this analysis. During a mean follow-up of 8.0 ± 1.5 years, we observed 136 coronary events and 304 deaths. In subjects with TAC>0 vs TAC = 0, the incidence of nonfatal MI was 4.2% vs 2.0% (p < 0.001), and all-cause mortality was 8.9% vs 5.2% (p < 0.001). Risks for coronary events and for all-cause mortality increased significantly with increasing TAC-scores (p < 0.001). After adjustment for CV risk factors, body mass index (BMI) and CV medication, a unit increase of TAC on a logarithmic scale (log(TAC + 1)) remained independently associated with coronary events (hazard ratio (HR) (95% confidence interval (CI)): 1.06 (1.00-1.14), p = 0.03) and all-cause mortality (HR 1.06 (1.01-1.12), p < 0.01). After further adjustment for CAC-score (log(CAC + 1)), hazard ratios were attenuated for both endpoints (coronary events: 0.98 (0.91-1.05), p = 0.56, all-cause mortality: 1.03 (0.98-1.08), p = 0.33). When adding log(TAC + 1) to the model containing traditional risk factors and CAC, Harrell's C indices did not increase for coronary events (0.773-0.772, p = 0.66) or for all-cause mortality (0.741-0.743, p = 0.49). CONCLUSION: TAC is associated with incident coronary events and all-cause mortality independent of traditional CV risk factors in the general population. TAC fails to improve event prediction over CAC in both coronary events and all-cause mortality.

Person-centred web-based support--development through a Swedish multi-case study.

BACKGROUND: Departing from the widespread use of the internet in modern society and the emerging use of web applications in healthcare this project captures persons' needs and expectations in order to develop highly usable web recourses. The purpose of this paper is to outline a multi-case research project focused on the development and evaluation of person-centred web-based support for people with long-term illness. To support the underlying idea to move beyond the illness, we approach the development of web support from the perspective of the emergent area of person-centred care. The project aims to contribute to the ongoing development of web-based supports in health care and to the emerging field of person-centred care. METHODS/DESIGN: The research design uses a meta-analytical approach through its focus on synthesizing experiences from four Swedish regional and national cases of design and use of web-based support in long-term illness. The cases include children (bladder dysfunction and urogenital malformation), young adults (living close to persons with mental illness), and two different cases of adults (women with breast cancer and childbearing women with type 1 diabetes). All of the cases are ongoing, though in different stages of design, implementation, and analysis. This, we argue, will lead to a synthesis of results on a meta-level not yet described. DISCUSSION: To allow valid comparisons between the four cases we explore and problematize them in relation to four main aspects: 1) The use of people's experiences and needs; 2) The role of use of theories in the design of person-centred web-based supports; 3) The evaluation of the effects of health outcomes for the informants involved and 4) The development of a generic person-centred model for learning and social support for people with long-term illness and their significant others. Person-centred web-based support is a new area and few studies focus on how web-based interventions can contribute to the development of person-centred care. In summary, the main intention of the project outlined here is to contribute with both a synthesis of results on meta-level from four cases and a substantial contribution to the field person-centred care.

Utilization of collagen-based vascular closure devices in patients with severe peripheral artery disease.

BACKGROUND: Collagen-based vascular closure devices (VCD) are commonly used after catheterization with femoral access. However, data about complication rates due to the utilization of VCDs in patients with known peripheral artery disease (PAD) of the lower limbs are inconsistent and patients with significant PAD are excluded in most VCD trials. In this study, we aimed to assess complication rates of collagen-based VCDs in patients with significant PAD. METHODS: Patients with significant PAD treated with a VCD (Angio-Seal; St Jude Medical, Inc) after percutaneous therapeutic interventions of lower extremities were included in this study. Significant PAD was defined as Fontaine ≥2b. In-hospital complications (bleeding, spurious aneurysm, vessel occlusion, dissection, surgical repair, vasovagal reaction) were recorded. RESULTS: A total of 121 patients (64.6 ± 11.3 years, 77% male) were included. PAD stage IIb was present in 99 patients (stage III in 8 patients, stage IV in 14 patients). A total of 112 treatments (93.3%) processed without complications (major complication rate, 1.7%; minor complication rate, 5.0%). There was a trend toward higher prevalence of complications with increasing size of closure device and with the stage of PAD; however, this trend was not statistically significant (P>.05 for all). CONCLUSION: We report moderate complication rates of collagen-based VCDs in patients with significant PAD. Our data suggest that Angio-Seal may be safe in patients with PAD after catheter intervention. Further randomized trials with larger sample size comparing VCD with standard manual compression in patients with significant PAD are required.

Refining definitions of periodontal disease and caries for prediction models of incident tooth loss.

AIM: To assess the suitability of different definitions of caries and periodontitis for inclusion in tooth loss prediction models. MATERIALS AND METHODS: The Study of Health in Pomerania (SHIP) is a population-based cohort study conducted in 1997-2001 (SHIP-0) and 2002-2006 (SHIP-1). This sample comprised 2,780 subjects aged 20-81 years with complete information on dental and periodontal status [DMFS status, clinical attachment loss (CAL) and probing depth (PD)]. Analyses on five-year tooth loss were limited to half-mouth data. RESULTS: The predictive value of tested definitions was markedly age- and gender-dependent: in 20-39-aged men, the number of decayed or filled surfaces best predicted the number of lost teeth, whereas in young women CAL≥4 mm performed best. In older subjects, periodontal definitions were superior to caries definitions: mean CAL performed best in 40-59-year olds, whereas AL- or PD-related definitions predicted best in 60-81-year olds. On tooth level, mean CAL was the superior definition to assess 5-year incident tooth loss in all strata except for young men. CONCLUSIONS: Caries parameters best predicted incident tooth loss in men aged 20-39 years; in the intermediate and oldest age group and in young women, mean AL was most informative. Therefore, prediction models need to be developed for different age and gender groups.

Early random capillary glucose level screening and multidisciplinary antenatal teamwork to improve outcome in gestational diabetes mellitus.

BACKGROUND: This study describes maternal and neonatal characteristics and delivery outcome in women with gestational diabetes mellitus [GDM], compared to a control group. METHODS: A retrospective observational study of 719 women with GDM was undertaken in a Swedish urban district. All other parturients at the same hospital served as the control group. GDM was diagnosed using random capillary glucose levels at fixed intervals, beginning early in pregnancy. An oral glucose tolerance test was performed at glucose levels>or=7.0 mmol/l (127.8 mg/dl). Data was analysed according to glucose levels at diagnosis, ie, mild or severe GDM. RESULTS: GDM was diagnosed in 2.28% of the women who were older and had higher Body Mass Index [BMI]. A high proportion was of non-Nordic origin (44.5%); they had severe GDM more often (49.1%) than the Nordic group (33.1%). The GDM-mild group had less complications and abnormalities, compared to the GDM-severe group, although both groups differed from the control group in this respect. Delivery was spontaneous in 70.2% of GDM-mild, 65.7% of GDM-severe and 81.0% of the control group. LGA (+2 SD) was found in 4.8, 10.5 and 3.2%, respectively. CONCLUSION: Early non-fasting random universal screening and multidisciplinary antenatal teamwork intervention seems to be favourable, with low rates of excessive fetal growth, instrumental vaginal delivery and caesarean section.