Development and validation of a mobile phone application developed for measuring dietary fiber intake

We have developed a mobile phone application for measuring the intake of dietary fiber and validated the ability of the application to accurately capture this intake against measurements registered by a dietary record. We also investigated what food groups contributed most to the total, soluble, and insoluble dietary fiber intake. Twenty-six randomly selected Swedish women aged 35–85 years were included and randomized to either start to register dietary intake in the application or by a dietary record, during three consecutive days. After a washout period of at least two weeks, the participants used the other method. We found that the difference in measured mean fiber intake between the dietary record and the application was two grams independent of the total intake per day. A statistically significant correlation between fiber intake as measured by the two methods was found (rho = 0.65, p < 0.001). Vegetables and roots were the predominantly contributing foods to total and soluble fiber intake. Bread and crackers contributed most to insoluble fiber intake. In conclusion, the application may be considered as a useful and easy-to-use method to measure dietary fiber intake

Dose-response relationships of intestinal organs and excessive mucus discharge after gynaecological radiotherapy

Background The study aims to determine possible dose-volume response relationships between the rectum, sigmoid colon and small intestine and the ‘excessive mucus discharge’ syndrome after pelvic radiotherapy for gynaecological cancer. Methods and materials From a larger cohort, 98 gynaecological cancer survivors were included in this study. These survivors, who were followed for 2 to 14 years, received external beam radiation therapy but not brachytherapy and not did not have stoma. Thirteen of the 98 developed excessive mucus discharge syndrome. Three self-assessed symptoms were weighted together to produce a score interpreted as ‘excessive mucus discharge’ syndrome based on the factor loadings from factor analysis. The dose-volume histograms (DVHs) for rectum, sigmoid colon, small intestine for each survivor were exported from the treatment planning systems. The dose-volume response relationships for excessive mucus discharge and each organ at risk were estimated by fitting the data to the Probit, RS, LKB and gEUD models. Results The small intestine was found to have steep dose-response curves, having estimated dose-response parameters: γ : 1.28, 1.23, 1.32, D : 61.6, 63.1, 60.2 for Probit, RS and LKB respectively. The sigmoid colon (AUC: 0.68) and the small intestine (AUC: 0.65) had the highest AUC values. For the small intestine, the DVHs for survivors with and without excessive mucus discharge were well separated for low to intermediate doses; this was not true for the sigmoid colon. Based on all results, we interpret the results for the small intestine to reflect a relevant link. Conclusion An association was found between the mean dose to the small intestine and the occurrence of ‘excessive mucus discharge’. When trying to reduce and even eliminate the incidence of ‘excessive mucus discharge’, it would be useful and important to separately delineate the small intestine and implement the dose-response estimations reported in the study

A Preparatory Study for a Randomized Controlled Trial of Dietary Fiber Intake During Adult Pelvic Radiotherapy

Background: Patients undergoing pelvic radiotherapy are often advised to omit fiber-rich foods from their diet to reduce the adverse effects of treatment. Scientific evidence supporting this recommendation is lacking, and recent studies on animals and humans have suggested that there is a beneficial effect of dietary fiber for the alleviation of symptoms. Randomized controlled studies on dietary fiber intake during pelvic radiotherapy of sufficient size and duration are needed. As preparation for such a large-scale study, we evaluated the feasibility, compliance, participation rate, and logistics and report our findings here in this preparatory study. Methods: In this preparatory study of a fiber intervention trial, Swedish gynecological cancer patients scheduled for radiotherapy were recruited between January 2019 and August 2020. During the intervention, the participants filled out questionnaires and used an application. They also consumed a fiber supplement at first in powder form, later in capsules. Blood- and fecal samples were collected. The study is registered in clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04534075?cond=fidura&draw=2&rank=1). Results: Among 136 approached patients, 57 started the study and the participation rate for primary outcomes was 63% (third blood sample) and 65% (third questionnaire). Barely half of the participants provided fecal samples. Providing concise and relevant information to the patients at the right time was crucial in getting them to participate and stay in the study. The most common reasons for declining participation or dropping out were the expected burden of radiotherapy or acute side effects. Tailoring the ambition level to each patient concerning the collection of data beyond the primary endpoints was an important strategy to keep the dropout rate at an acceptable level. Using capsules rather than psyllium in powder form made it much easier to document intake and to create a control group. During the course of the preparatory study, we improved the logistics and for the last 12 participants included, the participation rate was 100% for the earliest primary outcome. Conclusion: A variety of adjustments in this preparatory study resulted in an improved participation rate, which allowed us to set a final protocol and proceed with the main study

A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method

BACKGROUND: Maternal perception of decreased fetal movements is commonly used to assess fetal well-being. However, there are different opinions on whether healthcare professionals should encourage maternal observation of fetal movements, as researchers claim that raising awareness increases unnecessary interventions, without improving perinatal health. We aimed to investigate whether cesarean sections and labor induction increase by raising women's awareness of fetal movements through Mindfetalness. Further, we aimed to study perinatal health after implementing Mindfetalness in maternity care. METHODS: In a cluster randomized controlled trial, 67 maternity clinics were allocated to Mindfetalness or routine care. In the Mindfetalness group, midwives distributed a leaflet telling the women to focus on the character, strength and frequency of the fetal movements without counting each movement. The instruction was to do so for 15 min daily when the fetus was awake, from gestational week 28 until birth. In this sub-group analysis, we targeted women born in Sweden giving birth from 32 weeks' gestation. We applied the intention-to-treat principle. RESULTS: The Mindfetalness group included 13,029 women and the Routine-care group 13,456 women. Women randomized to Mindfetalness had less cesarean sections (18.4% vs. 20.0%, RR 0.92, CI 0.87-0.97) and labor inductions (19.2% vs. 20.3%, RR 0.95, CI 0.90-0.99) compared to the women in the Routine-care group. Less babies were born small for gestational age (8.5% vs. 9.3%, RR 0.91, CI 0.85-0.99) in the Mindfetalness group. Women in the Mindfetalness group contacted healthcare due to decreased fetal movements to a higher extent than women in the Routine care group (7.8% vs. 4.3%, RR 1.79, CI 1.62-1.97). The differences remain after adjustment for potential confounders. CONCLUSIONS: Raising awareness about fetal movements through Mindfetalness decreased the rate of cesarean sections, labor inductions and small-for-gestational age babies. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02865759 ). Registered 12 August 2016, www.clinicaltrials.gov

Epidural use among women with spontaneous onset of labour : An observational study using data from a cluster-randomised controlled trial

OBJECTIVE: To investigate whether the proportion of pregnant women who use epidural analgesia during birth differed between women registered at a maternity clinic randomised to Mindfetalness or to routine care. DESIGN: An observational study including women born in Sweden with singleton pregnancies, with spontaneous onset of labour from 32 weeks' gestation. Data used from a cluster-randomised controlled trial applying the intention-to-treat principle in 67 maternity clinics where women were randomised to Mindfetalness or to routine care. ClinicalTrials.gov (NCT02865759). INTERVENTIONS: Midwives were instructed to distribute a leaflet about Mindfetalness to pregnant women at 25 weeks' gestation. Mindfetalness is a self-assessment method for the woman to use to become familiar with the unborn baby's fetal movement pattern. When practising the method in third trimester, the women are instructed to daily lie down on their side, when the baby is awake, and focus on the movements' intensity, character and frequency (but not to count each movement). FINDINGS: Of the 18 501 women with spontaneous onset of labour, 47 percent used epidural during birth. Epidural was used to a lower extent among women registered at a maternity clinic randomised to Mindfetalness than women in the routine-care group (46.2% versus 47.8%, RR 0.97, CI 0.94-1.00, p= 0.04). Epidural was more common among primiparous women, women younger than 35 years, those with educational levels below university, with BMI ≥25 and with a history of receiving psychiatric care or psychological treatment for mental illness. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Pregnant women who were informed about a self-assessment method, with the aim of becoming familiar with the unborn baby's fetal movement pattern, used epidural to a lower extent than women who were not informed about the method. Future studies are needed to investigate and understand the association between Mindfetalness and the reduced usage of epidural during birth

Cohort profile : an observational longitudinal data collection of health aspects in a cohort of female cancer survivors with a history of pelvic radiotherapy-a population-based cohort in the western region of Sweden.

PURPOSE: The study 'Health among women after pelvic radiotherapy' was conducted in response to the need for more advanced and longitudinal data concerning long-term radiotherapy-induced late effects and chronic states among female cancer survivors. The objective of this paper is to detail the cohort profile and the study procedure in order to provide a sound basis for future analyses of the study cohort. PARTICIPANTS: Since 2011, and still currently ongoing, participants have been recruited from a population-based study cohort including all female patients with cancer, over 18 years of age, treated with pelvic radiotherapy with curative intent at Sahlgrenska University Hospital in Gothenburg, in the western region of Sweden, which covers 1.7 million of the Swedish population. The dataset presented here consists of baseline data provided by 605 female cancer survivors and 3-month follow-up data from 260 individuals with gynaecological, rectal or anal cancer, collected over a 6-year period. FINDINGS TO DATE: Data have been collected from 2011 onwards. To date, three studies have been published using the dataset reporting long-term radiation-induced intestinal syndromes and late adverse effects affecting sexuality, the urinary tract, the lymphatic system and physical activity. These projects include the evaluation of interventions developed by and provided in a nurse-led clinic. FUTURE PLANS: This large prospective cohort offers the possibility to study health outcomes in female pelvic cancer survivors undergoing a rehabilitation intervention in a nurse-led clinic, and to study associations between demographics, clinical aspects and long-term late effects. Analysis focusing on the effect of the interventions on sexual health aspects, preinterventions and postinterventions, is currently ongoing. The cohort will be expanded to comprise the entire data collection from 2011 to 2020, including baseline data and data from 3-month and 1-year follow-ups after interventions. The data will be used to study conditions and treatment-induced late effects preintervention and postintervention

Country of birth, educational level and other predictors of seeking care due to decreased fetal movements : An observational study in Sweden using data from a cluster-randomised controlled trial

OBJECTIVES: To identify predictors of seeking care for decreased fetal movements and assess whether care-seeking behaviour is influenced by Mindfetalness. DESIGN: Observational study with data from a cluster-randomised controlled trial. SETTING: 67 maternity clinics and 6 obstetrical clinics in Sweden. PARTICIPANTS: All pregnant women with a singleton pregnancy who contacted the obstetrical clinic due to decreased fetal movements from 32 weeks' gestation of 39 865 women. METHODS: Data were collected from a cluster-randomised controlled trial where maternity clinics were randomised to Mindfetalness or routine care. Mindfetalness is a self-assessment method for women to use daily to become familiar with the unborn baby's fetal movement pattern. OUTCOME MEASURES: Predictors for contacting healthcare due to decreased fetal movements. RESULTS: Overall, 5.2% (n=2059) of women contacted healthcare due to decreased fetal movements, among which 1287 women (62.5%) were registered at a maternity clinic randomised to Mindfetalness and 772 women (37.5%) were randomised to routine care. Predictors for contacting healthcare due to decreased fetal movements were age, country of birth, educational level, parity, prolonged pregnancy and previous psychiatric care (p<0.001). The main differences were seen among women born in Africa as compared with Swedish-born women (2% vs 6%, relative risk (RR) 0.34, 95% CI 0.25 to 0.44) and among women with low educational level compared with women with university-level education (2% vs 5.4%, RR 0.36, 95% CI 0.19 to 0.62). Introducing Mindfetalness in maternity care increased the number of women seeking care due to decreased fetal movements overall. CONCLUSION: Women with country of birth outside Sweden and low educational level sought care for decreased fetal movements to a lesser extent compared with women born in Sweden and those with university degrees. Future research could explore whether pregnancy outcomes can be improved by motivating women in these groups to contact healthcare if they feel a decreased strength or frequency of fetal movements. TRIAL REGISTRATION NUMBER: NCT02865759

Pregnancy outcomes among women born in Somalia and Sweden giving birth in the Stockholm area : a population-based study

BACKGROUND: Studies report that women born in some African countries, after migrating to the Nordic countries, have worse pregnancy outcomes than women born in the receiving countries. With the aim of identifying unmet needs among Somali-born women, we here study this subgroup. OBJECTIVE: We compared pregnancy outcomes among women born in Somalia to women born in Sweden. Further, we investigated whether the proactive maternal observation of fetal movements has effects on birth outcomes among women born in Somalia. METHODS: In Stockholm, half of the maternity clinics were randomized to intervention, in which midwives were instructed to be proactive towards women by promoting daily self-monitoring of fetal movements. Data for 623 women born in Somalia and 26 485 born in Sweden were collected from a population-based register. RESULTS: An Apgar score below 7 (with stillbirth counting as 0) at 5 minutes was more frequent in babies of women born in Somalia as compared to babies of women born in Sweden (RR 2.17, 95% CI 1.25-3.77). Babies born small for gestational age were more common among women born in Somalia (RR 2.22, CI 1.88-2.61), as were babies born after 41 + 6 gestational weeks (RR 1.65, CI 1.29-2.12). Somali-born women less often contacted obstetric care for decreased fetal movements than did Swedish-born women (RR 0.19, CI 0.08-0.36). The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group. CONCLUSIONS: A higher risk of a negative outcome for mother and baby is seen among women born in Somalia compared to women born in Sweden. We suggest it may be worthwhile to investigate whether a Somali-adapted intervention with proactivity concerning self-monitoring of fetal movements may improve pregnancy outcomes in this migrant population

Sexual health and wellbeing after pelvic radiotherapy among women with and without a reported history of sexual abuse : important issues in cancer survivorship care

AIMS: Sexual abuse is a women's health concern globally. Although experience of sexual abuse and cancer may constitute risk factors for sexual dysfunction and low wellbeing, the effects of sexual abuse have received little attention in oncology care. This study aims to explore sexual health and wellbeing in women after pelvic radiotherapy and to determine the relationship between sexual abuse and sexual dysfunction, and decreased wellbeing. METHODS: Using a study-specific questionnaire, data were collected during 2011-2017 from women with gynaecological, anal, or rectal cancer treated with curative pelvic radiotherapy in a population-based cohort and a referred patient group. Subgroup analyses of data from women with a reported history of sexual abuse were conducted, comparing socio-demographics, diagnosis, aspects of sexual health and wellbeing. RESULTS: In the total sample of 570 women, 11% reported a history of sexual abuse and among these women the most common diagnosis was cervical cancer. More women with than without a history of sexual abuse reported feeling depressed (19.4% vs. 9%, p = 0.007) or anxious (22.6% vs. 11.8%, p = 0.007) and suffering genital pain during sexual activity (52% vs. 25.1%, p = 0.011, RR 2.07, CI 1.24-3.16). In the total study cohort, genital pain during sexual activity was associated with vaginal shortness (68.5% vs. 31.4% p ≤ 0.001) and inelasticity (66.6% vs. 33.3%, p ≤ 0.001). CONCLUSIONS: Our findings suggest that a history of both sexual abuse and pelvic radiotherapy in women are associated with increased psychological distress and sexual impairment, challenging healthcare professionals to take action to prevent retraumatisation and provide appropriate interventions and support

Sexual health and wellbeing among female pelvic cancer survivors following individualized interventions in a nurse-led clinic

Purpose Treatment-induced sexual and intestinal dysfunctions coexist among women after pelvic radiotherapy. We aimed to explore if sexual health and wellbeing may be improved after radiotherapy following nurse-led interventions and if an association exists between improved intestinal health and sexual health. Methods A population-based cohort of women treated with pelvic radiotherapy underwent interventions at a nurse-led clinic at Sahlgrenska University Hospital, Sweden, from 2011 to 2017. Self-reported questionnaires were used, pre- and post-intervention, to compare self-reported changes in sexual health and wellbeing. A regression model was performed to explore the association between intestinal and wellbeing variables. Results Among the 260 female pelvic cancer survivors included in the study, more women reported increased than decreased satisfaction with overall sexual health post-intervention (26.0% vs. 15.3%, p = 0.035). They also reported significantly reduced superficial genital pain (25.8% vs. 13.1%, p <= 0.025), reduced deep genital pain (23.1% vs. 8.0%, p <= 0.001), increased QoL (42.7% vs. 22.4%, p < 0.001), and reduced levels of depression (43.1% vs. 28.0%, p = 0.003) or anxiety (45.9% vs. 24.4%, p < 0.001) post-intervention. We found a significant association between reduced urgency to defecate and improved satisfaction with overall sexual health (RR 3.12, CI 1.27-7.68, p = 0.004) and between reduced urgency to defecate with fecal leakage and reduced anxious mode (RR 1.56, CI 1.04-2.33, p = 0.021). Conclusion Sexual health and wellbeing can be improved by interventions provided in a nurse-led clinic focusing on physical treatment-induced late effects. Further research to optimize treatment strategies in female pelvic cancer survivors is needed