Interprofessional follow-up for people at risk of type 2 diabetes in primary healthcare - a randomized controlled trial with embedded qualitative interviews.

OBJECTIVE: To examine the effects of an empowerment-based interprofessional lifestyle intervention program among people at risk of type 2 diabetes on knowledge, skills, and confidence in self-management, health, psychological well-being, and lifestyle characteristics, and to explore the participants' perceptions of participating in the intervention. DESIGN AND METHODS: In line with the Medical Research Council complex interventions research methods framework, we conducted a randomized controlled trial with embedded qualitative interviews in primary healthcare clinics in Norway between 2019-2021. Of the patients at risk (The Finnish Diabetes Risk Score Calculator (FINDRISC) ≥15 or Body Mass Index (BMI) ≥30) 142 accepted the invitation, and 14 participants from the intervention group participated in individual interviews after the 12-month follow-up. Our primary outcome was the Patient Activation Measure (PAM-13). Secondary outcomes were EQ-5D-5L, EQ-VAS, WHO-Overall health, WHO-Overall QOL, weight, height, waist circumference, and regularity of physical activity. We used thematic analysis to analyse the qualitative data. RESULTS: There was no clinically relevant differences of neither the primary nor the secondary endpoints between intervention and control group. As to the qualitative data, we identified two distinct features: 'Meaningful perspectives on lifestyle changes' and 'Lifestyle change is not a linear process due to challenges faced along the way' putting ownership of their choices in life into picture. CONCLUSION: The negative results of the RCT stand in contrast to the findings given by the participants voices, perceiving the intervention as a key eye opener placing their health challenges in perspective. How to interpret these seemingly conflicting findings of participants being seen, heard, and understood, helping them to take more conscious ownership of their choices in life, and at the same time demonstrating no improvements in symptoms or measures, is a dilemma that needs further exploration. We should be careful to implement interventions that do not demonstrate any effects on the quantitative outcomes.

Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial.

PURPOSE: Follow-up after breast cancer with regular visits has failed to detect recurrences, be cost-effective, and address patient needs. METHODS: MyHealth is a phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT02949167). Patients, who recently completed primary treatment for stage I-II breast cancer, were randomly assigned in variable block sizes and stratified by age and human epidermal growth factor receptor 2 status to intervention or control follow-up. The nurse-led intervention comprised three to five individual self-management sessions, regular reporting of symptoms, and navigation to health care services. The control follow-up comprised regular outpatient visits with the physician. The primary outcome was breast cancer-specific quality of life (QoL) measured by the Trial Outcome Index-Physical/Functional/Breast summary score of the Functional Assessment of Cancer Therapy-Breast 2 years after random assignment. Secondary outcomes were fear of recurrence, anxiety, depression, and health care utilization. Analyses were intention-to-treat and P values were two-sided with 95% confidence level set at 0.005 because of multiple comparisons. RESULTS: Among 1,101 eligible patients, 875 were invited and 503 were randomly assigned to control (n = 252) or intervention (n = 251) follow-up. At 2 years, patients in the intervention group reported a significantly and clinically relevant higher QoL (mean, 75.69 [standard deviation [SD], 12.27]) than patients in the control group (71.26 [SD, 14.08]), with a mean difference of 5.05 (95% CI, 3.30 to 6.79; P < .001). The intervention group reported significantly less fear of recurrence, anxiety, and depression; they had fewer physician consultations but more nurse contacts and an unchanged diagnostic imaging pattern. The effect on all outcomes was stable through a 3-year follow-up. CONCLUSION: The MyHealth study suggested a new strategy for follow-up after early breast cancer as it provided significant improvements in QoL.

Evaluation of an interprofessional follow-up intervention among people with type 2 diabetes in primary care-A randomized controlled trial with embedded qualitative interviews.

With an ageing population and improved treatments people live longer with their chronic diseases, and primary care clinics face more costly and difficult-to-treat multimorbid patients. To meet these challenges, current guidelines for the management of type 2 diabetes suggest that an interprofessional team should collaborate to enhance the delivery of worthwhile self-management support interventions. In this study, we aimed to evaluate the effects of an empowerment-based interprofessional follow-up intervention in people with type 2 diabetes in primary care on patient-reported outcomes, biomarkers and weight, and to explore the experiences of patients attending the intervention. We invited patients during regular visits to their general practitioners. The 12-month intervention included 1) empowerment-based counselling; 2) a standardized medical report. The control group received consultations with physicians only. The primary outcome was the Patient Activation Measure, a patient-reported measure assessing individual knowledge, skills, and confidence integral to managing one's health and healthcare. After the trial we conducted qualitative interviews. We observed no difference in the primary outcome scores. On secondary outcomes we found a significant between-group intervention effect in favor of the intervention group, with mean differences in glycemic control after 12 months (B [95% CI] = -8.6 [-17.1, -0.1] mmol/l; p = 0.045), and significant within-group changes of weight (B [95% CI] = -1.8 kg [-3.3, -0.3]; p = 0.02) and waist circumference (B [95% CI] = -3.9 cm [-7.3, -0.6]; p = 0.02). The qualitative data showed that the intervention opened patients' eyes for reflections and greater awareness, but they needed time to take on actions. The patients emphasized that the intervention gave rise to other insights and a greater understanding of their health challenges. We suggest testing the intervention among patients with larger disease burden and a more expressed motivation for change.

Pre-pregnancy gene expression signatures are associated with subsequent improvement/worsening of rheumatoid arthritis during pregnancy.

BACKGROUND: While many women with rheumatoid arthritis (RA) improve during pregnancy and others worsen, there are no biomarkers to predict this improvement or worsening. In our unique RA pregnancy cohort that includes a pre-pregnancy baseline, we have examined pre-pregnancy gene co-expression networks to identify differences between women with RA who subsequently improve during pregnancy and those who worsen. METHODS: Blood samples were collected before pregnancy (T0) from 19 women with RA and 13 healthy women enrolled in our prospective pregnancy cohort. RA improvement/worsening between T0 and 3rd trimester was assessed by changes in the Clinical Disease Activity Index (CDAI). Pre-pregnancy expression profiles were examined by RNA sequencing and differential gene expression analysis. Weighted gene co-expression network analysis (WGCNA) was used to identify co-expression modules correlated with the improvement/worsening of RA during pregnancy and to assess their functional relevance. RESULTS: Of the 19 women with RA, 14 improved during pregnancy (RAimproved) while 5 worsened (RAworsened). At the T0 baseline, however, the mean CDAI was similar between the two groups. WGCNA identified one co-expression module related to B cell function that was significantly correlated with the worsening of RA during pregnancy and was significantly enriched in genes differentially expressed between the RAimproved and RAworsened groups. A neutrophil-related expression signature was also identified in the RAimproved group at the T0 baseline. CONCLUSION: The pre-pregnancy gene expression signatures identified represent potential biomarkers to predict the subsequent improvement/worsening of RA during pregnancy, which has important implications for the personalized treatment of RA during pregnancy.

Self-determination theory interventions versus usual care in people with diabetes: a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Autonomy-supporting interventions, such as self-determination theory and guided self-determination interventions, may improve self-management and clinical and psychosocial outcomes in people with diabetes. Such interventions have never been systematically reviewed assessing both benefits and harms and concurrently controlling the risks of random errors using trial sequential analysis methodology. This systematic review investigates the benefits and harms of self-determination theory-based interventions compared to usual care in people with diabetes. METHODS: We used the Cochrane methodology. Randomized clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory in any setting were eligible. A comprehensive search (latest search April 2022) was undertaken in CENTRAL, MEDLINE, Embase, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S, and CPCI-SSH to identify relevant trials. Two authors independently screened, extracted data, and performed risk-of-bias assessment of included trials using the Cochrane risk-of-bias tool 1.0. Our primary outcomes were quality of life, all-cause mortality, and serious adverse events. Our secondary outcomes were diabetes distress, depressive symptoms, and nonserious adverse events not considered serious. Exploratory outcomes were glycated hemoglobin and motivation (autonomy, controlled, amotivation). Outcomes were assessed at the end of the intervention (primary time point) and at maximum follow-up. The analyses were conducted using Review Manager 5.4 and Trial Sequential Analysis 0.9.5.10. Certainty of the evidence was assessed by GRADE. RESULTS: Our search identified 5578 potentially eligible studies of which 11 randomized trials (6059 participants) were included. All trials were assessed at overall high risk of bias. We found no effect of self-determination theory-based interventions compared with usual care on quality of life (mean difference 0.00 points, 95% CI -4.85, 4.86, I2 = 0%; 225 participants, 3 trials, TSA-adjusted CI -11.83, 11.83), all-cause mortality, serious adverse events, diabetes distress, depressive symptoms, adverse events, glycated hemoglobulin A1c, or motivation (controlled). The certainty of the evidence was low to very low for all outcomes. We found beneficial effect on motivation (autonomous and amotivation; low certainty evidence). CONCLUSIONS: We found no effect of self-determination-based interventions on our primary or secondary outcomes. The evidence was of very low certainty. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.

Pregnancy-associated systemic gene expression compared to a pre-pregnancy baseline, among healthy women with term pregnancies.

Background: Pregnancy is known to induce extensive biological changes in the healthy mother. Little is known, however, about what these changes are at the molecular level. We have examined systemic expression changes in protein-coding genes and long non-coding (lnc) RNAs during and after pregnancy, compared to before pregnancy, among healthy women with term pregnancies. Methods: Blood samples were collected from 14 healthy women enrolled in our prospective pregnancy cohort at 7 time-points (before, during and after pregnancy). Total RNA from frozen whole blood was used for RNA sequencing. Following raw read alignment and assembly, gene-level counts were obtained for protein-coding genes and long non-coding RNAs. At each time-point, cell type proportions were estimated using deconvolution. To examine associations between pregnancy status and gene expression over time, Generalized Estimating Equation (GEE) models were fitted, adjusting for age at conception, and with and without adjusting for changes in cell type proportions. Fold-changes in expression at each trimester were examined relative to the pre-pregnancy baseline. Results: Numerous immune-related genes demonstrated pregnancy-associated expression, in a time-dependent manner. The genes that demonstrated the largest changes in expression included several that were neutrophil-related (over-expressed) and numerous immunoglobulin genes (under-expressed). Estimated cell proportions revealed a marked increase in neutrophils, and less so of activated CD4 memory T cells, during pregnancy, while most other cell type proportions decreased or remained unchanged. Adjusting for cell type proportions in our model revealed that although most of the expression changes were due to changes in cell type proportions in the bloodstream, transcriptional regulation was also involved, especially in down-regulating expression of type I interferon inducible genes. Conclusion: Compared to a pre-pregnancy baseline, there were extensive systemic changes in cell type proportions, gene expression and biological pathways associated with different stages of pregnancy and postpartum among healthy women. Some were due to changes in cell type proportions and some due to gene regulation. In addition to providing insight into term pregnancy among healthy women, these findings also provide a "normal" reference for abnormal pregnancies and for autoimmune diseases that improve or worsen during pregnancy, to assess deviations from normal.

Person-specific evidence has the ability to mobilize relational capacity: A four-step grounded theory developed in people with long-term health conditions.

Person-specific evidence was developed as a grounded theory by analyzing 20 selected case descriptions from interventions using the guided self-determination method with people with various long-term health conditions. It explains the mechanisms of mobilizing relational capacity by including person-specific evidence in shared decision-making. Person-specific self-insight was the first step, achieved as individuals completed reflection sheets enabling them to clarify their personal values and identify actions or omissions related to self-management challenges. This step paved the way for sharing these insights and challenges in a relationship with a supportive health professional, who could then rely on person-specific evidence instead of assumptions or a narrow disease perspective for shared decision-making. Trust in the evidence encouraged the supportive health professional to transfer it to the interdisciplinary team. Person-specific evidence then enhanced the ability of team members to apply general evidence in a meaningful way. The increased openness achieved by individuals through these steps enabled them to eventually share their new self-insights in daily life with other people, decreasing loneliness they experienced in self-management. Relational capacity, the core of the theory, is mobilized in both people with long-term health conditions and healthcare professionals. Further research on person-specific evidence and relational capacity in healthcare is recommended.

Feasibility and acceptability of an online guided self-determination program to improve diabetes self-management in young adults.

Objective: Evaluate the feasibility and acceptability of an online guided self-determination (GSD) program to improve diabetes self-management skills among young adults with type 1 diabetes (YAD). Methods: An online program comprising seven structured interactive conversations was designed. A pre- and post- interventional study used a sequential, two-phase multiple method design. Phase one comprised a training program for diabetes educators (DEs). In Phase two YAD participated in program and completed pre- and post-surveys assessing motivation to self-manage, perceived competence in diabetes and communication with DEs. Both YAD and DEs provided a program evaluation. Results: The online GSD program was acceptable, feasible and effective in improving autonomous motivation in self-management and communication with DEs. Easy access and program flexibility were highly appreciated by both participant groups and perceived to assist YAD to stay motivated. Conclusion: The program had a significant impact on the diabetes self-management of YAD and was a feasible and acceptable way to engage and communicate with DEs. The GSD platform contributes to age appropriate and person-centred diabetes self-management. It can potentially reach geographically distanced populations, or with social circumstances or other barriers impeding in-person service provision.

The process of health behaviour change following participation in a randomised controlled trial targeting prediabetes: A qualitative study.

AIM: To explore how participating in a randomised controlled trial affected motivation, barriers and strategies in the process of health behaviour change among individuals with prediabetes. METHODS: An extension to the PRE-D trial, a qualitative study investigated the efficacy of glucose-lowering interventions (metformin, dapagliflozin or exercise) compared with a control group among individuals with prediabetes and overweight/obesity. Data were collected through separate focus group interviews with participants using semi-structured interview guides inspired by health behaviour change theories. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis with an inductive-deductive approach. RESULTS: Four interrelated themes were generated from interviews: (1) 'self-construction of prediabetes', on how participants understood the term 'prediabetes', (2) 'altered health image', on how participants' health perceptions were affected, (3) 'personal strategies for health behaviour change', on different ways to attempt to implement behaviour changes and (4) 'the process of health behaviour change', on how participants progressed and relapsed while trying to change behaviour. Themes relate to the health belief model, self-determination theory, self-efficacy and the trans-theoretical model of change. Participants shared their experiences and thoughts during interviews and inspired each other, which led some participants to develop a new perspective on prediabetes severity and increased their motivation for behaviour change. CONCLUSIONS: How participants perceived and accepted, rejected or neglected prediabetes appeared to affect their health images and whether they realised a need for behaviour change. Their achievements during interventions, health literacy, self-efficacy and perceived support from their social networks, professionals and technological aids influenced the maintenance of health behaviour changes.

Parents' and Health Professionals' Attitudes to Advancing Primary MMR Vaccine Administration from Fifteen to Six Months of Age-A Qualitative Thematic Analysis Embedded in a Randomized Trial.

Declining levels and duration of passively acquired maternal antibodies prompted a Danish trial to test the feasibility of advancing administration of the first measles, mumps, and rubella vaccine (MMR1) from 15 to 6 months of age. A trial-embedded qualitative study aimed to understand parents' (N = 24) and health professionals' (N = 11) attitudes about the measles, mumps, and rubella vaccine (MMR) in general and about advancing MMR1 administration. Overly positive parent attitudes were contrasted by members of a vaccine-skeptical organization including parents considering that their child was seriously vaccine-injured long ago. Parents' attitudes to advancing MMR1 mirrored their attitudes about the MMR vaccine in general, with four positions along a continuum of trust in the healthcare system: unquestioning trust, acceptance after careful consideration, challenging indecisiveness, and defensive rejection. Low tolerance was identified between vaccine supporters and vaccine opponents. Parents of children with perceived serious vaccine-related injuries described lifelong unresolved feelings of guilt. Supporters of advanced MMR1 saw it as a timely and convenient administration of a well-known vaccine, whereas opponents feared it would disturb the children's immature immune systems and emphasized difficulties in recognizing side effects so early in life. Health professionals were supportive of advancing the MMR1 vaccine and they carefully challenged the parents. Current MMR vaccine supporters show readiness to advance MMR1 administration.

Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial.

INTRODUCTION: In the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have an effect on haemoglobin A1c and diabetes distress in people with type 1 diabetes. Previous trials were at risk of uncertainty. Thus, the objective is to investigate the benefits and harms of a GSD intervention versus an attention control group intervention in adults with type 2 diabetes. METHODS AND ANALYSIS: This trial protocol is guided by the The Standard Protocol Items: Recommendations for International Trials Statement. We describe the protocol for a pragmatic randomised, dual-centre, parallel-group, superiority clinical trial testing a GSD intervention versus an attention control for people with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from two diverse regions of Denmark. The experimental stepped-care intervention will consist of three to five GSD sessions lasting up to 1 hour with a trained GSD facilitator. The sessions will be conducted face to face, by video conference or over the telephone. The attention controls will receive three to five sessions lasting up to an hour with a communication-trained healthcare professional provided face to-face, by video conference, or over the telephone. Participants will be included if they have type 2 diabetes,>18 years old, are not pregnant. Participants will be assessed before randomisation, at 5-month, and 12-month follow-up, the latter being the primary. The primary outcome is diabetes distress. Secondary outcomes are quality of life, depressive symptoms and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation and serious adverse events. Data will be collected using REDCap and analysed using Stata V.16. ETHICS AND DISSEMINATION: The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its latest form, International Harmonisation of Good Clinical Practice guidelines and the applicable regulatory requirement(s). The trial has been approved by the Danish Data Protection Agency (P-2020-864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol, but exempted the trial protocol from full review (H-20003638). The results of the trial will be presented at the outpatient clinics treating people with type 2 diabetes, at national and international conferences as well as to associations for people with diabetes and their relatives. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04601311.

Is gene expression among women with rheumatoid arthritis dysregulated during a postpartum flare?

BACKGROUND: To evaluate our hypotheses that, when rheumatoid arthritis (RA) flares postpartum, gene expression patterns are altered compared to (a) healthy women, (b) RA women whose disease activity is low or in remission postpartum, and (c) pre-pregnancy expression profiles. METHODS: Twelve women with RA and five healthy women were included in this pilot study. RA disease activity and postpartum flare were assessed using the Clinical Disease Activity Index (CDAI). Total RNA from frozen whole blood was used for RNA sequencing. Differential gene expression within the same women (within-group) over time, i.e., postpartum vs. third trimester (T3) or pre-pregnancy (T0), were examined, using a significance threshold of q < 0.05 and fold-change ≥ 2. RESULTS: Nine of the women with RA experienced a flare postpartum (RAFlare), while three had low disease activity or were in remission (RANoFlare) during that time frame. Numerous immune-related genes were differentially expressed postpartum (vs. T3) during a flare. Fold-changes in expression from T3 to postpartum were mostly comparable between the RAFlare and healthy groups. At 3 months postpartum, compared to healthy women, several genes were significantly differentially expressed only among the RAFlare women, and not among the RANoFlare women. Some of these genes were among those whose "normal" expression was significantly modulated postpartum, and the postpartum expression patterns were significantly altered during the RA flare. There were also some genes that were significantly differentially expressed in RAFlare compared to both healthy and RANoFlare women, even though their expression was not significantly modulated postpartum. Furthermore, while postpartum expression profiles were similar to those at pre-pregnancy among healthy women, significant differences were found between those time points among the RAFlare women. CONCLUSIONS: The large majority of gene expression changes between T3 and 3 months postpartum among RA women who flared postpartum reflected normal postpartum changes also seen among healthy women. Nonetheless, during a postpartum flare, a set of immune-related genes showed dysregulated expression compared to healthy women and women with RA whose disease activity was low or in remission during the same time frame, while other genes demonstrated significant differences in expression compared to RA pre-pregnancy levels.

Self-determination theory interventions versus usual care in people with diabetes: a protocol for a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Existing self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain. Autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement through shared decision-making and collaborative goal setting. Autonomy supportive interventions aim to promote that the person with diabetes' motivation is autonomous meaning that the person strives for goals they themselves truly believe in and value. This is the goal of self-determination theory and guided self-determination interventions. Self-determination theory has been reviewed but without assessing both benefits and harms and accounting for the risk of random errors using trial sequential analysis. The guided self-determination has not yet been systematically reviewed. The aim of this protocol is to investigate the benefits and harms of self-determination theory-based interventions versus usual care in adults with diabetes. METHODS/DESIGN: We will conduct the systematic review following The Cochrane Collaboration guidelines. This protocol is reported according to the PRISMA checklist. A comprehensive search will be undertaken in the CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S and CPCI-SSH to identify relevant trials. We will include randomised clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory provided face-to-face or digitally by any healthcare professional in any setting. The primary outcomes will be quality of life, mortality, and serious adverse events. The secondary will be diabetes distress, depressive symptoms and adverse events not considered serious. Exploratory outcomes will be glycated haemoglobin and motivation. Outcomes will be assessed at the end of the intervention and at maximum follow-up. The analyses will be performed using Stata version 16 and trial sequential analysis. Two authors will independently screen, extract data from and perform risk of bias assessment of included studies using the Cochrane risk of bias tool. Certainty of the evidence will be assessed by GRADE. DISCUSSION: Self-determination theory interventions aim to promote a more autonomous patient engagement and are commonly used. It is therefore needed to evaluate the benefit and harms according to existing trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.

Impact of the Guided Self-Determination Intervention among Adolescents with Co-Existing ADHD and Medical Disorder: A Mixed Methods Study.

Adolescents with ADHD are at increased risk of having a co-existing medical disorder. Research shows that having co-existing ADHD and a medical disorder interferes with the adolescents' daily life, creating a dual task that cannot be managed as two independent disorders. Interventions to support adolescents in managing the dual task of living with co-existing ADHD and medical disorder are needed. The Guided-Self-Determination intervention might be suitable for this population, as it is an empowerment-based intervention facilitating patient involvement and self-management of a disease. The purpose of this study was to evaluate how the Guided Self-Determination intervention impacted 10 adolescents with ADHD and a co-existing medical disorder. The study used a convergent mixed methods design. Quantitative data measuring support from nurses, support from parents, and self-management were collected though self-reported questionnaires at baseline, 3 months, and 6 months and were analyzed with descriptive statistics. Qualitative data capturing the adolescents' experiences of the intervention and the intervention's impact on support from nurses, parents, and self-management were collected through semi-structured interviews and analyzed thematically. Results of the quantitative and qualitative analyses were integrated in a mixed methods analysis. The integrated results suggest that this intervention may improve adolescents' management of the difficulties of living with co-existing ADHD and a medical disorder, and that self-insight and nurse support are prerequisites for developing self-management strategies. However, the results showed that the intervention did not impact parental support. Further research is needed to evaluate the impact of the intervention on a larger scale.

The Rheumatoid Arthritis Gene Expression Signature Among Women Who Improve or Worsen During Pregnancy: A Pilot Study.

OBJECTIVE: To assess whether gene expression signatures associated with rheumatoid arthritis (RA) before pregnancy differ between women who improve or worsen during pregnancy, and to determine whether these expression signatures are altered during pregnancy when RA improves or worsens. METHODS: Clinical data and blood samples were collected before pregnancy (T0) and at the third trimester (T3) from 11 women with RA and 5 healthy women. RA disease activity was assessed using the Clinical Disease Activity Index (CDAI). At each timepoint, RA-associated gene expression signatures were identified using differential expression analysis of RNA sequencing profiles between women with RA and healthy women. RESULTS: Of the women with RA, 6 improved by T3 (RAimproved), 3 worsened (RAworsened),and 2 were excluded. At T0, mean CDAI scores were similar in both groups (RAimproved 11.2 ± 9.8; RAworsened 13.8 ± 6.7; Wilcoxon rank-sum test: P = 0.6). In the RAimproved group, 89 genes were differentially expressed at T0 (q < 0.05 and fold change ≥ 2) compared to healthy women. When RA improved at T3, 65 of 89 (73%) of these genes no longer displayed RA-associated expression. In the RAworsened group, a largely different RA gene expression signature (429 genes) was identified at T0. When RA disease activity worsened at T3, 207 of 429 (48%) genes lost their differential expression, while an additional 151 genes became newly differentially expressed. CONCLUSION: In our pilot dataset, pre-pregnancy RA expression signatures differed between women who subsequently improved or worsened during pregnancy, suggesting that inherent genomic differences may influence how pregnancy affects disease activity. Further, these RA signatures were altered during pregnancy as disease activity changed.

Smoking cessation prolongs survival in female cancer survivors - the Danish nurse cohort.

PURPOSE: To explore smoking cessation between cancer survivors and cancer-free women, and the potential survival benefits from smoking cessation in cancer surviving women. METHOD: We pooled 46,334 responses from the Danish Nurse Cohort. The cohort consists of female nurses, who were invited for surveys in 1993, 1999 and 2009. Participants were linked to nationwide registries on hospitalization, cause of death and migration through 2016. Odds for smoking cessation by cancer diagnosis were computed in propensity score matched logistic regression models, while survival by postdiagnosis smoking cessation was estimated in cox proportional hazards models. RESULTS: Eligible for analysis were 7841 women (mean age = 56.7 years, SD ± 7.2), who were smokers at baseline and survived to the next follow-up survey. Of these, 545 women were diagnosed with cancer and matched by propensity score (1:2) with 1090 cancer-free women. Odds for smoking cessation were significantly higher in cancer-diagnosed women compared to their cancer-free peers (OR = 1.31, 95% CI: 1.06-1.61). Moreover, mortality risk was significantly lower among cancer survivors who stopped smoking (HR = 0.64, 95% CI: 0.46-0.91), compared to persistent smokers. CONCLUSIONS: The results suggest considerable survival benefits from smoking cessation in cancer surviving female nurses, and that the time surrounding cancer diagnosis may serve as a teachable moment for smoking cessation. However, due to substantial methodological limitations embedded in the study, careful interpretation of the presented results is warranted. Future studies are needed to demonstrate the effects of diagnosis on smoking cessation as well as the effects of smoking cessation on survival in female cancer populations.

Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

BACKGROUND: SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and monitoring as usual. To ensure high quality of the trial intervention as well as of patient care, we have developed a multilingual web-based training program to train relevant staff and test their competence. As we enter an under-explored area of e-learning, we have conducted a pilot study on the first of the five modules comprising the web-based training program to test the feasibility of developing such a program for an international trial with limited resources. METHODS: The module in this study focuses on the principles and practice of NIRS monitoring. The pedagogical idea was to integrate training and certification. One-hundred doctors and nurses from five Neonatal Intensive Care Units across China, Spain and Denmark were invited to participate in the pilot study. Upon completion of the NIRS module, participants were invited to evaluate their experience by completing an online survey. Data from closed-ended questions were analysed using descriptive statistics while data from open-ended questions underwent thematic analysis. RESULTS: In total, 81 of 100 invited staff members entered the training module and completed the online survey. The median time and the number of questions to pass the module was 15 minutes and seven questions, respectively. Most staff found the academic level of the learning material and quiz appropriate (85% and 93% of all staff members, respectively), as well as agreeing that the module was relevant to prepare them to 'use the NIRS device' (90%). Thematic analysis revealed issues such as a discrepancy between learning material and quiz questions, lack of clarity, and technical issues. CONCLUSION: We provide evidence of the feasibility of developing a multilingual web-based training program for an international trial, despite challenges such as low budget, language barriers and possibly differences in the clinical training of staff. Exploring the integration of training and certification for international trials, the positive results of this study motivate further developments. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

Adolescents' Perceptions of Living With Co-Existing ADHD and Medical Disorder in Denmark.

AIM: The study aim was to explore adolescents' with co-existing ADHD and medical disorder (MD) perceptions of everyday life and support from parents and healthcare professionals. DESIGN AND METHODS: In this qualitative study, 10 adolescents aged 13-17 years diagnosed with ADHD and a MD were included from a general pediatric hospital clinic and a child and adolescent psychiatric hospital clinic. Data obtained through semi-structured interviews were analyzed using thematic analysis. RESULTS: The adolescents' perceptions were categorized into four themes: 1) ADHD perceived as part of the adolescent's self-understanding - yet with daily frustrations, 2) MD perceived as an interruption in everyday life, 3) ADHD and MD - an overlooked dual task, and 4) the need for supportive relationships in navigating ADHD and MD. CONCLUSION: Living with co-existing ADHD and MD is a complex dual task, as ADHD and MD interfere with each other in everyday life. However, the adolescents overlook the dual task as they believe their difficulties would be resolved if the MD was eliminated. Moreover, supportive relationships are essential in navigating the complexities in living with co-existing ADHD and MD. Nevertheless, the adolescents take a passive role in the encounters with the healthcare professionals, whereas they are more active in encounters with peers, parents and teachers. PRACTICE IMPLICATIONS: Healthcare professionals treating and caring for adolescents with co-existing ADHD and MD need interventions facilitating patient involvement in a patient-centered approach to support both adolescents and healthcare professionals in recognizing the dual task of having co-existing ADHD and MD.

Labeled as lucky: contradictions between what women and healthcare professionals experience regarding the need for help after the early stages of gynecological cancer.

PURPOSE: To explore how participants perceived a nurse-led, person-centered intervention, Guided Self-Determination Gynecological Cancer (GSD-GYN-C) and how participants felt it influenced the challenges they faced and their rehabilitation after gynecological cancer surgery. METHODS: Participants were invited from a previously conducted randomized trial where GSD-GYN-C improved physical quality of life in the intervention group. Ten semi-structured interviews were conducted, transcribed, and analyzed using thematic analysis. RESULTS: Three central themes were identified: (1) "labeled as the lucky ones," which describes a contrast between the women's perceived problems and the healthcare professionals' tendency to stress their luck in being treated early and cured with no particular problems in sight, leading to an unintended delay in their rehabilitation process; (2) "personal reflections pave the way for change," which shows how new problem-solving skills were mobilized when reflection sheets and dialogue on GSD-GYN-C provided new insight into their situation and the feeling of being taken seriously; and (3) "emerging relational competence," which describes the new skills the women developed in interacting with family, friends, colleagues, and healthcare professionals. CONCLUSIONS: As a supplement to usual care, GSD-GYN-C remedied a tendency among healthcare professionals to underestimate problems in the early stages of gynecological cancer, and GSD-GYN-C involved the women in their rehabilitation process characterized by active problem-solving in relationships with other people.

About me as a person not only the disease - piloting Guided Self-Determination in an outpatient endometriosis setting.

INTRODUCTION: Endometriosis is a chronic disease affecting 5-10% of women in the reproductive age. Despite surgical and medical treatment, many women struggle with pain, infertility, sexual dysfunction, depression, distress and reduced workability, affecting their overall quality of life. The usual follow-up procedures may not support the women's self-management of this condition. Therefore, person-centred empowerment-based approaches are needed. AIM: To assess if the implementation of the Guided Self-Determination method targeted women with complex endometriosis appeared feasible and supported self-management. METHODS: Guided Self-Determination was offered to 10 out-patients with complex endometriosis. Each of the women had five conversations based on prefilled disease-specific reflection sheets. A qualitative evaluation was conducted in 2016-2017 covering semi-structured, telephone interviews and focus group interviews, which were analysed using thematic analysis. Additionally, we assessed if the women changed the self-reported questionnaires, Endometriosis Health Profile 30 and the Patient Activation Measure from before and after the conversations. RESULTS: We identified four themes: feeling alone with the disease; establishing a meaningful relationship with healthcare professionals in a traditional hospital setting; person-specific knowledge facilitated new behaviours and; accepting a chronic condition - the beginning of a process. All dimensions of the Endometriosis Health Profile 30 and the Patient Activation Measure appeared to improve at two weeks and so did almost all the dimensions of Endometriosis Health Profile 30 after 1 year. CONCLUSIONS: The implementation of the Guided Self-Determination method appeared feasible and the women developed self-management skills in relation to endometriosis and its symptoms. This was achieved by increasing insight into their needs and behaviours and gaining new knowledge about the disease itself. The before-and-after assessment suggested benefit of the intervention, but this should be further tested in a randomised trial.