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Interpretation of clinical trial REsults PRESENTed with frequentist vs. Bayesian statistics (RE-PRESENT): protocol for a randomized controlled trial conducted as an online survey in REDCap

BACKGROUND The overall purpose is to investigate how the COVID-19 pandemic has affectedindividuals who have been or are going through assessment or treatmentfor involuntary childlessness, and their processes of trying to havechildren. Previous research on involuntary childlessness in relation to thepandemic has mainly been medical and quantitative, and there has beena lack of qualitative studies that explore the subject area on a more indepth level. The study is a project in ReproUnion, Challenge 5. MATERIALS AND METHODS In this qualitative study, we used semistructured interviews to collectdata. The study includes individuals who have been or are going throughassessment or treatment for involuntary childlessness in Sweden andDenmark during the pandemic. Participants were recruited from bothpublic and private care. 26 individuals took part in the study, of which 18women and eight men. The participants were between 24 53 years oldand the sample consisted of both heterosexual and same sex couples. Theinterviews addressed experiences of assessment and treatment ofinvoluntary childlessness during the COVID-19 pandemic in relation to e.g.access to care, socioeconomic factors and intimate relationships. RESULTS AND CONCLUSION The preliminary results show that the pandemic has affected the patients in many ways and made an already challenging processev en more difficult.Obstacles mentioned are for example limit access to care with longer queues and uncertainty regarding when the treatment can be resumed. Many of therespondents has also suffered from the absence of partners during care visits. Furthermore, the fear of being infected by the Corona virus, which couldcause the treatment to be postponed, has led to isolation and often a weaker support from family and friends. However, these neg ative consequenceshave affected patients to varying degrees, some worse than others. The results also show that the pandemic brought some posit ive consequences. For example, the isolation has been perceived as a relief for some as they easier could avoid being exposed to other people’s pre gna ncies as well as attendingbaptisms and baby showers. “It hasbeen extremely stressful for me tohear those messages about delays of thetreatment from the clinic ], as it has taken solong to get started , and, yes , I am notgetting any younger . That's how I feel . Forevery six months that goes by , I have kind oflost a chance to get pregnant.” "We are young and have no underlying healthproblems, but we still really had to isolateourselves, and we were very afraid that we wouldcatch a cold or suffer from Corona so that thetreatments would be cancelled. So, it was all thetime that you were afraid to meet people, andyou were afraid to meet your friends” “I think the biggest impact was that I was notallowed to accompany and that I was not allowedto participate, also in combination with this stressthat you could get sick. That was probably thebiggest impact for me and my wife.” CONTACT Ida Elisabet Hall Research assistant, social worker, master in sexology Centre for Sexology and Sexuality Studies, Malmö University ida.hall@mau.se

DAG and measured variables. The file shows the DAG used for variable selection and an timescale of measurement of included variables. (DOCX 86 kb)

Flow chart. The file shows the flowchart of selection of study participants. (DOCX 44 kb)

Supplemental material, hpq678669 for Comparison of three infertility-specific measures in men and women going through assisted reproductive technology treatment by Juliana Pedro, Yoon Frederiksen, Lone Schmidt, Hans J Ingerslev, Robert Zachariae and Mariana V Martins in Journal of Health Psychology

Objective: To estimate the costs to the public health care system of couples in medically assisted reproduction. Material and methods: Longitudinal cohort study among n=739 infertile couples who started a fertility treatment at one of four selected public fertility clinics in Denmark during the period January 2000 – August 2001. Data were collected prospectively by a self-administered questionnaire for both partners, and retrospectively from medical records through a 5 year follow-up study (ending 2005-2006) of each treatment at the chosen clinic. Cost data were collected from one of the participating clinics. Flow diagrams were drawn for each of three different treatment cycles: 1) in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with fresh embryos, 2) frozen/thawed embryo transfer cycle (FET), and 3) intrauterine insemination using partners’ semen (IUI-H) or donor semen (IUI-D). Direct costs at each step in the flow diagram were identified, measured and valuated in DKK through a bottom-up procedure. Indirect costs (in accounting sense) were allocated to each treatment cycle by a top-down method. While direct costs were measured in detail, the indirect costs were allocated on the basis of number of visits as key. Costs in 2001-prices were inflated to 2012 prices by using a constructed health sector price- and wage index. Results: A total of 434 live births with one or more children per birth were included. Average total costs per live birth in 2012-prices is estimated to 76,427 DKK, of which 65,790 are direct costs and 10,637 are allocated indirect costs to cover overhead costs of the hospital and use of space. Per treated couple – irrespective of whether the treatment ended with a live birth or not – average total costs are estimated to 46,953 DKK, of which 40,418 are direct costs and 6,535 are indirect costs.

INTRODUCTION: There are complex causal associations between mental disorders, fertility treatment, fertility treatment outcome and infertility per se. Eating disorders cause endocrine disturbances, anovulation and thereby infertility, and research has shown that infertility as well as unsuccessful assisted reproductive technology (ART) treatment are potential risk factors for developing a depression on a long-term basis. Despite the fact that worldwide more than 400 000 ART treatment cycles are performed every year, the causal associations between mental disorders, use of medication for mental disorders and ART treatment in both sexes have only been sparsely explored.METHOD AND ANALYSIS: The main objective of this national register-based cohort study is to assess women's and men's mental health before, during, and after ART treatment in comparison with the mental health in an age-matched population-based cohort of couples with no history of ART treatment. Furthermore, the objective is to study the reproductive outcome of ART treatment among women who have a registered diagnosis of a mental disorder or have used medication for mental disorders prior to ART treatment compared with women in ART treatment without a mental disorder. We will establish the Danish National ART-Couple (DANAC) cohort including all women registered with ART treatment in the Danish in vitro fertilisation Register during 1994-2009 (N=42 915) and their partners. An age-matched population-based comparison cohort of women without ART treatment (n=215 290) and their partners will be established. Data will be cross-linked with data from national registers on psychiatric disorders, medical prescriptions for mental disorders, births, causes of deaths and sociodemographic data. Survival analyses and other statistical analyses will be conducted on the development of mental disorders and use of medication for mental disorders for women and men both prior to and after ART treatment.

Kapitlet beskriver og diskuterer nogle dokumenterede forskelle i helbred, sygelighed kontaktmønster med sundhedsvæsenet mellem kvinder og mænd. Indledningsvist præsenteres ’køn’ som begreb, efterfulgt af et afsnit om kønsforskellene i dødeligheden og hvilke konsekvenser, dette har. Dernæst ses på kønsforskelle i sygdomsforekomst og der fokuseres på nogle få sygdomme, hvor der er udprægede forskelle mellem kønnene: Hjerte-kar sygdomme og depression. Desuden belyses omfanget af ulykker og vold blandt de to køn samt de to køns medicinforbrug og kontakt til sundhedsvæsenet. Dernæst følger et afsnit om reproduktiv sundhed, som er relateret til sundhed inden for alle aspekter af det reproduktive system og dets funktion og processer. Kapitlet afsluttes med en diskussion af de to køn i relation til familie, arbejde og sundhed.