Outcomes of oocyte vitrification in trans masculine individuals.

RESEARCH QUESTION: What are the outcomes and experiences of oocyte vitrification treatment in trans masculine individuals (TMI) before and after testosterone use? DESIGN: This retrospective cohort study was conducted at the Amsterdam UMC in the Netherlands between January 2017 and June 2021. The TMI who had completed an oocyte vitrification treatment were consecutively approached for participation. Informed consent was provided by 24 individuals. Participants (n = 7) who initiated testosterone therapy were advised to stop 3 months before stimulation. Demographic characteristics and oocyte vitrification treatment data were retrieved from medical records. Evaluation of the treatment was collected via an online questionnaire. RESULTS: The median age of participants was 22.3 years (interquartile range 21.1-26.0) and mean body mass index was 23.0 kg/m2 (SD 3.2). After ovarian hyperstimulation, a mean of 20 oocytes (SD 7) were retrieved and a mean of 17 oocytes (SD 6) could be vitrified. Aside from a lower cumulative FSH dose, there were no significant differences between the prior testosterone users and testosterone naïve TMI. The overall satisfaction of oocyte vitrification treatment in participants was high. Hormone injections were considered the most strenuous part of treatment by 29% of participants, closely followed by oocyte retrieval (25%). CONCLUSIONS: No difference in response to ovarian stimulation was found for oocyte vitrification treatment between the prior testosterone users and testosterone naïve TMI. The questionnaire identified hormone injections as the most burdensome aspect of oocyte vitrification treatment. This information can be used to improve gender sensitive fertility counselling and fertility treatment strategies.

Electronic Health Program to Empower Patients in Returning to Normal Activities After Colorectal Surgical Procedures: Mixed-Methods Process Evaluation Alongside a Randomized Controlled Trial.

BACKGROUND: Long-term recovery takes longer than expected despite improved surgical techniques and Enhanced Recovery After Surgery programs. An electronic health (eHealth) care program ("ikherstel") was developed to partially substitute perioperative care for patients undergoing colorectal surgical procedures. Successfully tested eHealth programs are not always implemented in usual care, and it is, therefore, important to evaluate the process to optimize future implementation. OBJECTIVE: The aim of this study was to evaluate whether the eHealth intervention was executed as planned. METHODS: A mixed-methods process evaluation was carried out alongside a multicenter randomized controlled trial (RCT). This evaluation was performed using the Linnan and Steckler framework for the quantitative part of this study, measuring the components reach, dose delivered, dose received, fidelity, and participants' attitudes. Total implementation scores were calculated using the averaging approach, in which the sum of all data points is divided by the number of data points and the total adherence to the protocol is measured. For the qualitative part, the Unified Theory of Acceptance and Use of Technology framework was used. The quantitative data were based on participants' questionnaires, a logistic database, a weblog, and participants' medical files and were obtained by performing semistructured interviews with participants of the RCT. RESULTS: A total of 151 participants of 340 eligible patients were included in the RCT, of which 73 participants were allocated to the intervention group. On the basis of the quantitative process data, total implementation scores for the website, mobile app, electronic consult, and activity tracker were 64%, 63%, 44%, and 67%, respectively. Participants in the qualitative part experienced the program as supportive and provided guidance on their recovery process after colorectal surgery. Most frequently mentioned barriers were the limited interaction with and feedback from health care professionals and the lack of tailoring of the convalescence plan in case of a different course of recovery. CONCLUSIONS: The intervention needs more interaction with and feedback from health care professionals and needs more tailored guidance in case of different recovery or treatment courses. To ensure a successful implementation of the program in daily practice, some adjustments are required to optimize the program in a blended care form. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC= 5686 (Archieved by WebCite at http://www.webcitation.org/75LrJaHrr).

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

A Perioperative eHealth Program to Enhance Postoperative Recovery After Abdominal Surgery: Process Evaluation of a Randomized Controlled Trial.

BACKGROUND: Electronic health (eHealth) interventions have proven effective, but implementation in clinical practice is difficult. More research focusing on the implementation process of eHealth interventions is necessary. OBJECTIVE: The objective of this study was to describe the process evaluation of a perioperative eHealth intervention, aiming to enhance recovery after laparoscopic abdominal surgery. METHODS: A process evaluation was carried out alongside a multicenter randomized controlled trial. Patients aged between 18 and 75 years who were scheduled for a laparoscopic cholecystectomy, hernia inguinal surgery, or laparoscopic adnexal surgery were included. The eHealth intervention comprised a website and mobile phone app with the possibility to develop a personalized convalescence plan, a section with information about the surgical procedure and the recovery period, the possibility to ask questions via an electronic consultation (eConsult), and an activity tracker. The process evaluation was carried out using the model of Linnan and Steckler, measuring components such as reach, dose delivered, dose received, fidelity, and participants' attitudes. Implementation scores were calculated based on the average of the four components. Quantitative data were collected by means of an electronic questionnaire, a logistic database, a weblog, and medical files. Qualitative data were collected by conducting interviews with a subsample of the study participants. RESULTS: A total of 344 of the 863 eligible patients were included in the study, which accounted for a reach of 39.9%, and 173 participants were randomized to the intervention group. The implementation scores of the different functions of the intervention ranged between 60% and 65%. The website, mobile phone app, and activity tracker were rated 7.3 to 7.6 on a scale of 1 to 10. Almost all participants who were interviewed about the eConsult function rated it as being of additional value if combined with the usual care but not as a replacement for usual care. CONCLUSIONS: Although participants were overall satisfied with the intervention, the implementation scores of the different functions of the intervention were fair. More research is needed to evaluate the barriers and facilitators for implementation of this perioperative eHealth intervention in normal practice outside study setting. TRIAL REGISTRATION: Netherlands Trial Registry NTR4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6vr02V4KK).

Three-dimensional saline infusion sonography compared to two-dimensional saline infusion sonography for the diagnosis of focal intracavitary lesions.

BACKGROUND: Focal abnormalities most commonly acquired within the uterine cavity include endometrial polyps (arising from the endometrium) and submucous fibroids (arising from the myometrium). These benign abnormalities can cause several problems, including abnormal uterine bleeding (AUB) and subfertility. Two-dimensional saline infusion sonography (2D SIS) is a minimally invasive test that can be used to diagnose these pathologies, but it is less accurate than hysteroscopy, which is a more invasive procedure by which an endoscope allows direct visualisation of the uterine cavity. Three-dimensional (3D) SIS appears to enhance sonographic visualisation within the uterine cavity, thereby offering a potentially more accurate minimally invasive diagnostic test. OBJECTIVES: Primary objectives • To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. • To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. In this case, any abnormality on either modality was regarded as a positive result ('OR' approach). Secondary objectives • To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.• To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference. SEARCH METHODS: We searched the following databases: Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PubMed, Cochrane Gynaecology and Fertility Group (CGF) Specialised Register and CGFG Diagnostic Test Accuracy (DTA) Specialised Register, clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Screening reference lists of appropriate studies was also performed. We screened for eligibility all studies identified from inception until March 2016. We performed searches with no date or language restrictions. SELECTION CRITERIA: The population of interest consisted of premenopausal women with AUB or subfertility and postmenopausal women with AUB. Diagnostic test accuracy studies, randomised controlled trials (RCTs) and prospective cohort studies were eligible for inclusion if they evaluated the accuracy of both 2D SIS and 3D SIS for the diagnosis of acquired intracavitary abnormalities with hysteroscopy used as the reference standard. In light of the lack of data for 3D SIS, we also included studies that evaluated the accuracy of 3D SIS alone. DATA COLLECTION AND ANALYSIS: Two review authors read all potentially eligible references after performing a first screening by title and abstract (LLN and FJRH). They independently extracted data to construct 2×2 tables from eligible studies and assessed studies for methodological quality using the QUADAS-2 tool (revised tool for quality assessment of diagnostic accuracy studies). To describe and visually present results, we produced in RevMan forest plots showing pairs of sensitivity and specificity together with 95% confidence intervals from each study, as well as raw receiver operating characteristic (ROC) plots. We displayed paired analyses in an ROC plot by linking sensitivity-specificity pairs from each study by using a dashed line. To compare 3D SIS versus 2D SIS, we restricted analyses to studies that provided 2×2 tables for both tests and used the bivariate meta-analysis of sensitivity and specificity. MAIN RESULTS: Thirteen studies (1053 women) reported the accuracy of 3D SIS for focal uterine abnormalities; 11 of these (846 women) were suitable for meta-analysis, and eight reported accuracy according to the type of focal abnormality. The design of the included studies seems applicable. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, we considered the overall quality of the evidence as low. The summary estimate (11 studies reporting absence or presence of abnormality at 3D SIS) for sensitivity was 94.5% (95% confidence interval (CI) 90.6% to 96.9%) and for specificity 99.4% (95% CI 96.2% to 99.9%). Meta-analysis of the eight studies (N = 716) directly comparing 2D SIS versus 3D SIS showed summary sensitivity of 96.9% (95% CI 91.9% to 98.8%) and summary specificity of 99.5% (95% CI 96.1% to 100%) for 3D SIS. For 2D SIS, summary sensitivity was 90.9% (95% CI 81.2% to 95.8%) and summary specificity was 96.3% (95% CI 86.1% to 99.1%). The difference in accuracy between 2D SIS and 3D SIS was non-significant (P values of 0.07 for sensitivity and 0.10 for specificity). AUTHORS' CONCLUSIONS: Low-quality evidence suggests that 3D SIS may be very accurate in detecting intracavitary abnormalities. Meta-analysis revealed no statistically significant differences between 2D SIS and 3D SIS. Summary sensitivity and summary specificity are higher for 3D SIS, but margins of improvement are limited because 2D SIS is already very accurate. When the technology and appropriate expertise are available, 3D SIS offers an alternative to 2D SIS. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding.

Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial.

BACKGROUND: Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is established as the final treatment option when conservative treatment fails. Uterine artery embolization (UAE) in patients with symptomatic adenomyosis has demonstrated to reduce symptoms and improve quality of life. However, randomized controlled trials are lacking. OBJECTIVE: With this study, we aim to evaluate the impact of UAE on Health-Related Quality of Life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. METHODS: This is a multicenter non-blinded randomized controlled trial comparing UAE and hysterectomy. Eligible patients are symptomatic premenopausal women without the desire to conceive and who have symptomatic magnetic resonance imaging (MRI)-confirmed pure adenomyosis or dominant adenomyosis accompanied by fibroids. After obtaining informed consent, patients will be randomly allocated to treatment in a 2:1 UAE versus hysterectomy ratio. The primary objective is HRQOL at 6 months following the assigned intervention. Secondary outcomes are technical results, pain management, clinical outcomes, HRQOL, and cost effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE. RESULTS: Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At the time of submission of this article, data cleaning and analyses have not yet started. CONCLUSIONS: This trial will provide insight for caretakers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients' wellbeing and quality of life. TRIAL REGISTRATION: Netherlands Trial Register NTR5615; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615 (Archived by WebCite at http://www.webcitation.org/6xZRyXeIF).

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.

BACKGROUND: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. OBJECTIVE: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. METHODS: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. CONCLUSIONS: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. CLINICALTRIAL: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).

The cost effectiveness of a tailored, web-based care program to enhance postoperative recovery in gynecologic patients in comparison with usual care: protocol of a stepped wedge cluster randomized controlled trial.

BACKGROUND: The length of recovery after benign gynecological surgery and return to work frequently exceeds the period that is recommended or expected by specialists. A prolonged recovery is associated with a poorer quality of life. In addition, costs due to prolonged sick leave following gynecological surgery cause a significant financial burden on society. OBJECTIVE: The objective of our study was to present the protocol of a stepped wedge cluster randomized controlled trial to evaluate the cost effectiveness of a new care program for patients undergoing hysterectomy and/or adnexal surgery for benign disease, compared to the usual care. METHODS: The care program under study, designed to improve convalescence and to prevent delayed return to work, targets two levels. At the hospital level, guidelines will be distributed among clinical staff in order to stimulate evidence-based patient education. At the patient level, additional perioperative guidance is provided by means of an eHealth intervention, equipping patients with tailored convalescence advice, and an occupational intervention is available for those patients at risk of prolonged sick leave. Due to the stepped wedge design of the trial, the care program will be sequentially rolled out among the 9 participating hospitals, from which the patients are recruited. Eligible for this study are employed women, 18-65 years of age, who are scheduled for hysterectomy and/or laparoscopic adnexal surgery. The primary outcome is full sustainable return to work. The secondary outcomes include general recovery, quality of life, self-efficacy, coping, and pain. The data will be collected by means of self-reported electronic questionnaires before surgery and at 2, 6, 12, 26, and 52 weeks after surgery. Sick leave and cost data are measured by monthly sick leave calendars, and cost diaries during the 12 month follow-up period. The economic evaluation will be performed from the societal perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of the patients started October 2011. The follow-up period will be completed in August 2014. Data cleaning or analysis has not begun as of this article's submission. CONCLUSIONS: We hypothesize the care program to be effective by means of improving convalescence and reducing costs associated with productivity losses following gynecological surgery. The results of this study will enable health care policy makers to decide about future implementation of this care program on a broad scale. TRIAL REGISTRATION: Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84).