One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and ...increased resistance to acute stress. CR/STF increases the expression of cytoprotective genes, increases immunomodulation via increased anti-inflammatory cytokine production, and decreases the expression of pro-inflammatory markers. As such, nutritional preconditioning by CR or STF represents a non-invasive and cost-effective method that could mitigate the effects of acute surgery-induced stress and postoperative fatigue. To investigate whether preoperative STF contributes to a reduction in fatigue after living-kidney donation, a randomized clinical trial is indicated.
We aim to determine whether 2.5 days of fasting reduces postoperative fatigue score in subjects undergoing living-kidney donation. In this randomized study, the intervention group will follow a preoperative fasting regime for 2.5 days with a low-dose laxative, while the control group will receive standard care. The main study endpoint is postoperative fatigue, 4 weeks after living-kidney donation. Secondary endpoints include the effect of preoperative fasting on postoperative hospital admission time, the feasibility of STF, and the postoperative recovery of donor and recipient kidney function. This study will provide us with knowledge of the feasibility of STF and confirm its effect on postoperative recovery.
Our study will provide clinically relevant information on the merits of caloric restriction for living-kidney donors and recipients. We expect to reduce the postoperative fatigue in living-kidney donors and improve the postoperative recovery of living-kidney recipients. It will provide evidence on the clinical merits and potential caveats of preoperative dietary interventions.
Netherlands Trial Register NL9262 . EudraCT 2020-005445-16 . MEC Erasmus MC MEC-2020-0778. CCMO NL74623.078.21.
BACKGROUND
European guidelines on fertility care emphasize that subfertile couples should receive information about their chances of a natural conception and should not be exposed to unnecessary ...treatments and risks. Prognostic models can help to estimate their chances and select couples with a good prognosis for tailored expectant management (TEM). Nevertheless, TEM is not always practiced. The aim of this study was to identify any barriers or facilitators for TEM among professionals and subfertile couples.
METHODS
A qualitative study was performed with semi-structured in-depth interviews of 21 subfertile patients who were counselled for TEM and three focus-group interviews of 21 professionals in the field of reproductive medicine. Two theoretical models were used to guide the interviews and the analyses. The primary outcome was the set of identified barriers and facilitators which influence implementation of TEM.
RESULTS
Among the subfertile couples, main barriers were a lack of confidence in natural conception, a perception that expectant management is a waste of time, inappropriate expectations prior to the first consultation, misunderstanding the reason for expectant management and overestimation of the success rates of treatment. Both couples and professionals saw the lack of patient information materials as a barrier. Among professionals, limited knowledge about prognostic models leading to a decision in favour of treatment was recognized as a main barrier. A main facilitator mentioned by the professionals was better management of patients’ expectations.
CONCLUSIONS
We identified several barriers and facilitators which can be addressed to improve the implementation of TEM. These should be taken into account when designing future implementation strategies.
•Use of jute sacks and straw balls as nesting material was studied in loose-housed and crated sows.•Effects of nesting material and housing were additive.•Loose housing and the provision of nesting ...materials reduced activity before parturition.•Loose housing and the provision of nesting materials reduced restlessness during parturition.•Less crushing events tended to occur in loose pens vs crates during parturition.
Sows are strongly motivated to perform nestbuilding behaviour before parturition. This behaviour is often restricted in commercial systems due to confinement of the sow and lack of suitable nesting material to be used on slatted floors. This study aimed to investigate effects of loose vs. crated housing and the provision of alternative nesting material on periparturient sow behaviour and piglet survival. In a 2 × 2 arrangement, sixty-eight sows were assigned to either loose housing or crates and were either or not provided with nesting material consisting of jute sacks and straw balls. All sows had a rope. Postures and manipulation of materials and pen were observed using 5 min scan sampling for the 12 h before and the 24 h after parturition. Behaviour during parturition was scored continuously and included nose-nose contact between sow and piglets and crushing incidences. No interactions between treatments were found. In the 12 h prepartum, loose housed sows showed less sitting (5 vs. 9%) and ventral lying (29 vs. 38%) and more lateral lying (33 vs. 23%) and floor manipulation (10 vs. 5%) than crated sows. During parturition, loose housed sows spent less time sitting (2 vs. 6%), had fewer postural changes (34 vs. 50), showed less fence manipulation (0.1 vs. 2%) and had more nose contact with piglets (56 vs. 19 times). Provision of nesting material increased pre-partum lying (63 vs. 57%), increased manipulation of materials (14 vs. 8%) and reduced manipulation of floor (5 vs. 10%) and fence (5 vs. 9%). During parturition, sows with nesting material showed less standing (6 vs. 10%) and more lying (90 vs. 84%). No effects were found on behaviour in the 24 h after parturition or on parturition duration (3.3 ± 0.1 h). During parturition, the times lying down and the number of piglets that died by crushing tended to be lower with provision of nesting material (0.1 vs. 0.3). In the 48 h after parturition, loose housed sows crushed more piglets. In conclusion, both loose housing and the provision of alternative nesting materials affected prepartum sow behaviour and resulted in less activity during parturition, with some tendencies for beneficial effects on (near-) crushing of piglets during this period. Thus, both loose housing and the provision of alternative nesting materials, likely particularly the jute sacks, have a beneficial effect on periparturient sow behaviour.
BACKGROUND
Supportive care is regularly offered to women with recurrent miscarriages (RMs). Their preferences for supportive care in their next pregnancy have been identified by qualitative research. ...The aim of this study was to quantify these supportive care preferences and identify women's characteristics that are associated with a higher or lower need for supportive care in women with RM.
METHODS
A questionnaire study was conducted in women with RMs (≥2 miscarriages) in three hospitals in the Netherlands. All women who received diagnostic work-up for RMs from January 2010 to December 2010 were sent a questionnaire. The questionnaire quantified supportive care options identified by a previous qualitative study. We next analysed associations between women's characteristics (age, ethnicity, education level, parity, pregnancy during questionnaire and time passed since last miscarriage) and their feelings about supportive care options to elucidate any differences between groups.
RESULTS
Two hundred and sixty-six women were asked to participate in the study. In total, 174 women responded (response rate 65%) and 171 questionnaires were analysed. Women with RM preferred the following supportive care options for their next pregnancy: a plan with one doctor who shows understanding, takes them seriously, has knowledge of their obstetric history, listens to them, gives information about RM, shows empathy, informs on progress and enquires about emotional needs. Also, an ultrasound examination during symptoms, directly after a positive pregnancy test and every 2 weeks. Finally, if a miscarriage occurred, most women would prefer to talk to a medical or psychological professional afterwards. The majority of women expressed a low preference for admission to a hospital ward at the same gestational age as previous miscarriages and for bereavement therapy. The median preference, on a scale from 1 to 10, for supportive care was 8.0. Ethnicity, parity and pregnancy at the time of the survey were associated with different preferences, but female age, education level and time passed since the last miscarriage were not.
CONCLUSIONS
Women with RM preferred a plan for the first trimester that involved one doctor, ultrasounds and the exercise of soft skills, like showing understanding, listening skills, awareness of obstetrical history and respect towards the patient and their miscarriage, by the health care professionals. In the event of a miscarriage, women prefer aftercare. Women from ethnic minorities and women who were not pregnant during the questionnaire investigation were the two patient groups who preferred the most supportive care options. Tailor-made supportive care can now be offered to women with RM.
The decision to pursue one's desire for children is a basic human right. For transgender and gender-diverse (TGD) people, gender-affirming care may alter the possibilities to fulfill one's desire for ...children due to the impact of this treatment on their reproductive organs. We systematically included 76 studies of varying quality describing the desire for children and parenthood; fertility counseling and utilization; and fertility preservation options and outcomes in TGD people. The majority of TGD people expressed a desire for children. Fertility preservation utilization rates were low as there are many barriers to pursue fertility preservation. The most utilized fertility preservation strategies include oocyte vitrification and sperm banking through masturbation. Oocyte vitrification showed successful outcomes, even after testosterone cessation. Sperm analyses when banking sperm showed a lower quality compared to cis male samples even prior to gender-affirming hormone treatment and an uncertain recovery of spermatogenesis after discontinuing treatment.
•Transgender and gender diverse (TGD) people may have a (future) desire for children, biologically or otherwise.•All TGD people should receive fertility counseling prior to puberty suppression and gender affirming treatment.•Oocyte vitrification outcomes in TGD people are comparable to cis population, even with prior testosterone use.•Semen preservation before gender affirming hormone treatment is strongly recommended.•TGD people’s journey to parenthood is related to their mental reproductive capacity, sexual attraction and gametes.
Abstract
STUDY QUESTION
What is the effectiveness of a multifaceted implementation strategy compared to usual care on improving the adherence to guideline recommendations on expectant management for ...couples with unexplained infertility?
SUMMARY ANSWER
The multifaceted implementation strategy did not significantly increase adherence to guideline recommendations on expectant management compared to care as usual.
WHAT IS KNOWN ALREADY
Intrauterine insemination (IUI) with or without ovarian hyperstimulation has no beneficial effect compared to no treatment for 6 months after the fertility work-up for couples with unexplained infertility and a good prognosis of natural conception. Therefore, various professionals and policy makers have advocated the use of prognostic profiles and expectant management in guideline recommendations.
STUDY DESIGN, SIZE, DURATION
A cluster randomized controlled trial in 25 clinics in the Netherlands was conducted between March 2013 and May 2014. Clinics were randomized between the implementation strategy (intervention, n = 13) and care as usual (control, n = 12). The effect of the implementation strategy was evaluated by comparing baseline and effect measurement data. Data collection was retrospective and obtained from medical record research and a patient questionnaire.
PARTICIPANTS/MATERIALS, SETTING, METHODS
A total of 544 couples were included at baseline and 485 at the effect measurement (247 intervention group/238 control group).
MAIN RESULTS AND THE ROLE OF CHANCE
Guideline adherence increased from 49 to 69% (OR 2.66; 95% CI 1.45–4.89) in the intervention group, and from 49 to 61% (OR 2.03; 95% CI 1.38–3.00) in the control group. Multilevel analysis with case-mix adjustment showed that the difference of 8% was not statistically significant (OR 1.31; 95% CI 0.67–2.59). The ongoing pregnancy rate within six months after fertility work-up did not significantly differ between intervention and control group (25% versus 27%: OR 0.72; 95% CI 0.40–1.27).
LIMITATIONS REASONS FOR CAUTION
There is a possible selection bias, couples included in the study had a higher socio-economic status than non-responders. How this affects guideline adherence is unclear. Furthermore, when powering for this study we did not take into account the unexpected improvement of adherence in the control group.
WIDER IMPLICATIONS OF THE FINDINGS
Generalization of our results to other countries with recommendations on expectant management might be questionable because barriers for expectant management can be very different in other countries. Furthermore, due to a large variation in improved adherence rate in the intervention group it will be interesting to further analyse the process of implementation in each clinic with a process evaluation on professionals and couples’ exposure to and experiences with the strategy.
STUDY FUNDING/COMPETING INTEREST(S)
Supported by Netherlands Organisation for Health Research and Development (ZonMW, project number 171203005). No competing interests.
TRIAL REGISTRATION NUMBER
Dutch trial Register, www.trialregister.nl NTR3405.
TRIAL REGISTRATION DATE
19 April 2012.
DATE OF FIRST PATIENT'S ENROLMENT
10 July 2012.
INTRODUCTION
Prediction models for spontaneous pregnancy are useful tools to prevent overtreatment, complications and costs in subfertile couples with a good prognosis. The use of such models and ...subsequent expectant management in couples with a good prognosis are recommended in the Dutch fertility guidelines, but not fully implemented. In this study, we assess risk factors for non-adherence to tailored expectant management.
METHODS
Couples with mild male, unexplained and cervical subfertility were included in this multicentre prospective cohort study. If the probability of spontaneous pregnancy within 12 months was ≥40%, expectant management for 6–12 months was advised. Multivariable logistic regression was used to identify patient and clinical characteristics associated with non-adherence to tailored expectant management.
RESULTS
We included 3021 couples of whom 1130 (38%) had a ≥40% probability of a spontaneous pregnancy. Follow-up was available for 1020 (90%) couples of whom 214 (21%) had started treatment between 6 and 12 months and 153 (15%) within 6 months. A higher female age and a longer duration of subfertility were associated with treatment within 6 months (OR: 1.06, 95% CI: 1.01–1.1; OR: 1.4; 95% CI: 1.1–1.8). A fertility doctor in a clinical team reduced the risk of treatment within 6 months (OR: 0.62; 95% CI: 0.39–0.99).
CONCLUSIONS
In couples with a favorable prognosis for spontaneous pregnancy, there is considerable overtreatment, especially if the woman is older and duration of the subfertility is longer. The presence of a fertility doctor in a clinic may prevent early treatment.
Background
In New Zealand, public funding for assisted reproductive technology (ART) is restricted to subfertile women who are unlikely to conceive spontaneously, based on clinical and social ...criteria known as the clinical priority access criteria (CPAC) score. The objective of this study was to compare this CPAC score with a prediction model for predicting spontaneous conception, developed in the Netherlands (the Hunault model).
Methods
We performed a cohort study and included couples with unexplained subfertility and assessed the measure of agreement and the performance of the CPAC score and the Hunault prediction score.
Results
Of 663 couples referred, 249 (38%) couples had unexplained subfertility. Of 246 women with full follow-up data, there were 143 women (58%) who had a live birth during the follow-up period, 65 (26%) after fertility treatment and 78 (32%) after natural conception. There were 100 couples (41%) who had a Hunault prediction score of <30%, which is the Dutch treatment threshold, and 36 couples (15%) who had a CPAC score of >65, which is the New Zealand threshold for publically funded treatment. There were 69 couples (28%) who meet the threshold for treatment in the Netherlands but did not meet the New Zealand threshold for public funding. The kappa coefficient as a measure of agreement of the two scores and their treatment thresholds was 0.30, suggesting a fair agreement. The area under the curve for the CPAC and Hunault scores were both 0.63, but the Hunault model performed better in calibration.
Conclusions
The CPAC score correlates fairly with the Hunault prediction score, although using the Hunault prediction model 26% more couples would be recommended for ART. The discriminative capacities of both scores were comparable, but the Hunault prediction score performed better in calibration. Funding models in New Zealand should consider treating those women with unexplained subfertility who are least likely to conceive spontaneously.
BACKGROUND
Prognostic models for natural conception help to identify subfertile couples with high chances of natural conception, who do not need fertility treatment yet. The use of such models and ...subsequent tailored expectant management (TEM) is not always practiced. Previous qualitative research has identified barriers and facilitators of TEM among patients and professionals. The aim of this study was to assess the prevalence of those barriers and facilitators and to evaluate which factors predict patients' appreciation of TEM and professionals' adherence to TEM.
METHODS
We performed a nationwide survey. Based on the previously identified barriers and facilitators two questionnaires were developed and sent to 195 couples and 167 professionals. Multivariate analysis was performed to evaluate which factors predicted patients' appreciation of TEM and professional adherence to TEM.
RESULTS
In total, 118 (61%) couples and 117 (70%) professionals responded and 96 couples and 117 professionals were included in the analysis. Patients' mean appreciation of TEM was 5.7, on a 10-point Likert scale. Patients with a lower appreciation of TEM had a higher need for patient information (P = 0.047). The professionals reported a mean adherence to TEM of 63%. Adherence to TEM was higher when professionals were fertility doctors (P = 0.041). Facilitators in the clinical domain were associated with a higher adherence to TEM (P = 0.091). Barriers in the professional domain had a negative impact on adherence to TEM (P = 0.008).
CONCLUSIONS
The limited implementation of TEM is caused by both patient and professional-related factors. This study provides practical tools to improve the implementation of TEM.
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