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Objective: The aim was to evaluate the 1‐year implant outcome and patient‐related outcome measures (PROMs) after maxillary sinus membrane elevation and coagulum (test) compared with maxillary sinus floor augmentation and a 1:1 ratio of autogenous bone graft from the buccal antrostomy and deproteinised porcine bone mineral (DPBM) (control). Materials and methods: Forty patients (30 female, 10 male) with a mean age of 50 years (range 25–71 years) and an alveolar ridge height between 4 and 7 mm were randomly allocated to test or control. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of the peri‐implant tissue, peri‐implant marginal bone loss, frequency of complications and PROMs using Oral Health Impact Profile‐14 combined with questionnaires assessing patient's perception of the peri‐implant soft tissue, implant crown, function of the implant, and total implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was 0.05. Results: All suprastructures and implants were well‐functioning after 1‐year of functional implant loading. No significant difference in any of the applied outcome measures was observed between test and control. Both treatments revealed high patient satisfaction scores and significant improvement in oral health‐related quality of life. Conclusion: There were no significant differences in implant outcome and PROMs between test and control, after 1‐year of functional implant loading. Neither of the treatments can therefore be considered better than the other. Thus, long‐term randomized controlled trials are needed before definitive conclusions can be provided about the two treatment modalities. [ABSTRACT FROM AUTHOR]

In statistical work, it is essential to have an overview of the data used. In, for example, biomedical articles, a standardized way of reporting summaries of continuous and categorical variables is "table 1". This standardized way of reporting can be useful in most cases of statistical work. The basetable command is a flexible and straightforward way to build and format such table reports. The final reports are easy to style into Stata Markup and Control Language, commaseparated values, HyperText Markup Language, LATEX or TEX, or Markdown and, for example, save into a file specified by the using modifier. Also, it is possible to export the reports created by basetable into Excel worksheets. Because of the General Data Protection Regulation, it has become necessary to blur information on individuals when making reports; in basetable, there are options to blur both categorical and continuous data. [ABSTRACT FROM AUTHOR]

Objective: The objective was to assess patient's perception of recovery after maxillary sinus membrane elevation (MSME) and blood coagulum (test) compared with maxillary sinus floor augmentation (MSFA) and 1:1 mixture of autogenous bone graft from the buccal antrostomy and deproteinized porcine bone mineral (DPBM) (control). Materials and methods: Forty healthy patients were randomly allocated to test or control. Oral health‐related quality of life (OHRQoL) was evaluated by Oral Health Impact Profile‐14 (OHIP‐14) at enrollment and 1 week postsurgical. Recovery was estimated by questionnaires and visual analog scale assessing pain, social and working isolation, physical appearance, eating and speaking ability, diet variations, sleep impairment, and discomfort after 1 week and 1 month. Mean differences were expressed with 95% confidence interval (CI). Association between OHRQoL and recovery was estimated. p‐value below.05 was considered statistically significant. Results: Maxillary sinus membrane elevation revealed 2.1 less days of pain (p =.03, 95% CI: 0.2–4.1) and 1.2 days of sick leave (p =.01, 95% CI: 0.3–2.1) compared with MSFA. No significant difference was observed in eating and speaking ability, physical appearance, work performance, and sleep impairment. No significant association between impaired OHRQoL and recovery was observed. Females reported 4.77 higher OHIP‐14 score compared with males (p =.01, 95% CI: 1.60–7.94), while association between age and OHIP‐14 was −0.10 (p =.28, 95% CI: −0.28 to 0.08). Conclusion: Maxillary sinus membrane elevation revealed significantly less days of pain and sick leave compared with MSFA. Harvesting of autogenous bone graft seems, therefore, to have a significant impact on perception of recovery. [ABSTRACT FROM AUTHOR]

Objective: The objective was to assess the one year implant treatment outcome and patient‐related outcome measures (PROMs) following maxillary sinus floor augmentation (MSFA) with autogenous bone graft (ABG) from the zygomatic buttress (control) compared with 1:1 mixture of ABG and anorganic porcine bone mineral (APBM) (Test I) or biphasic bone graft material (BBGM) (Test II). Materials and Methods: Sixty healthy patients (34 females, 26 males) were randomly allocated to either control or test groups. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of peri‐implant tissue, peri‐implant marginal bone loss, frequency of complications, and PROMs using Oral Health Impact Profile‐14 combined with questionnaire assessing patient perception of peri‐implant soft tissue, prosthetic solution, implant function, and implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was.05. Results: All suprastructures and implants were well‐functioning after one year of functional implant loading. There was no significant difference between control and test groups in any of the applied outcome measures. The implant stability significantly increased from implant placement to abutment connection within all groups (p <.001). High patient satisfaction and significant improvement in oral health‐related quality of life was also reported within all groups. Conclusion: This study demonstrates that MSFA with composite grafts containing minimal amounts of ABG reveals comparable implant treatment outcomes as compared with ABG alone, after one year of functional implant loading. Extensive ABG harvesting in conjunction with MSFA therefore seems not to be needed. [ABSTRACT FROM AUTHOR]

A recurring problem in statistics is estimating and visualizing nonlinear dependency between an effect and an effect modifier. One approach to handle this is polynomial regressions of some order. However, polynomials are known for fitting well only in limited ranges. In this article, I present a simple approach for estimating the effect as a contrast at selected values of the effect modifier. I implement this approach using the flexible restricted cubic splines for the point estimation in a new simple command, emc. I compare the approach with other classical approaches addressing the problem. [ABSTRACT FROM AUTHOR]

Background: Supplemental oxygen therapy is central to the treatment of acute hypoxaemic respiratory failure, a condition which remains a major driver for morbidity and mortality in intensive care. Despite several large randomised clinical trials comparing a higher versus a lower oxygenation target for these patients, significant differences in study design impede analysis of aggregate data and final clinical recommendations. Methods: This paper presents the protocol for conducting an individual patient data meta‐analysis where full individual patient data according to the intention‐to‐treat principle will be pooled from the HOT‐ICU and HOT‐COVID trials in a one‐step procedure. The two trials are near‐identical in design. We plan to use a hierarchical general linear mixed model that accounts for data clustering at a trial and site level. The primary outcome will be 90‐day all‐cause mortality while the secondary outcome will be days alive without life‐support at 90 days. Further, we outline 14 clinically relevant predefined subgroups which we will analyse for heterogeneity in the intervention effects and interactions, and we present a plan for assessing the credibility of the subgroup analyses. Conclusion: The presented individual patient data meta‐analysis will synthesise individual level patient data from two of the largest randomised clinical trials on targeted oxygen therapy in intensive care. The results will provide a re‐analysis of the intervention effects on the pooled intention‐to‐treat populations and facilitate subgroup analyses with an increased power to detect clinically important effect modifications. [ABSTRACT FROM AUTHOR]

Background: Minor alterations in thyroid function are frequent, and interpretation of thyroid function tests in the individual patient can be challenging. Furthermore, the choice of thyroid function test is debatable. To inform the debate, we performed a comparative evaluation of the variation in thyrotropin (TSH) and thyroxine (T4) in two different cohorts to illustrate the precision of TSH and T4 in the diagnosis and monitoring of thyroid dysfunction. Methods: A comparative analysis of two separate longitudinal studies previously surveyed with monthly blood sampling for one year among 35 subjects. Participants were included based on T4 within the reference range and TSH either within (euthyroid; n = 15) or above (subclinical hypothyroidism; n = 20) the laboratory reference range on two independent blood samplings before inclusion. Exclusion criteria were known thyroid disease or use of thyroid interfering medication. TSH and T4 in individual samples were measured in a single batch to prevent between-batch variation. The distributions TSH and T4 were compared among euthyroid and subclinical hypothyroid individuals, and bootstrap estimates were used to calculate area under the curve (AUC). Results: Collection of twelve, monthly blood samples in the 35 participants provided 420 samples, and data completeness was 100%. The mean TSH was 1.27/7.19 mIU/L and the mean total T4 was 106/85 nmol/L in euthyroid/subclinical hypothyroid participants. The subclinical hypothyroidism state deviated from the euthyroid by 20% for total T4 and by 466% for TSH. The overlap between the euthyroid and subclinical hypothyroid groups was 92.6% (389/420) for total T4 and 9.0% (38/420) of test results for TSH. The estimated AUC was 0.999 (95%-CI: 0.995; 1.00) for TSH and 0.853 (0.736; 0.935) for total T4. There was no confidence interval overlap between participant groups for TSH while there was a considerable overlap for total T4 (p < 0.001). Conclusion: The distributions of thyroid function tests illustrated how TSH outperforms T4 for detecting delicate differences in thyroid function in an individual. Thus, TSH was markedly better than T4 to discriminate between the subtle differences in thyroid function corroborating that TSH is the more sensitive and accurate index of thyroid function status in the individual patient. [ABSTRACT FROM AUTHOR]

Objective: To explore how the use of the ProPep® Nerve Monitoring System (ProPep Surgical, Austin, TX, USA) for intraoperative specific sparing of the pudendal nerve fibres influences postoperative functional outcomes after unilateral nerve‐sparing (UNS) or non‐nerve‐sparing (NNS) robot‐assisted radical prostatectomy (RARP). Patients and methods: We randomised 100 men undergoing UNS or NNS RARP to ProPep nerve monitoring during RARP (intervention) or standard of care RARP (control). Functional outcomes were assessed at 3, 6, and 12 months using the International Consultation on Incontinence Questionnaire Short Form (ICIQ‐SF), the International Prostate Symptom Score, the Danish Prostate Symptom Score, the International Index of Erectile Function, the Erection Hardness Scale, and 24‐h pad tests. The primary outcome was the difference in ICIQ‐SF score between the groups at 12 months. Secondary outcomes included differences in the remaining outcome measures and continence rates at all time points. Continence was defined as the use of no pads and the answer 'Never' to the question: 'How often do you experience urinary incontinence?' or a urine loss of <8 g on the 24‐h pad test. Results: A total of 82 patients were included in the per‐protocol analysis at 12 months with 41 in each group. At 12 months the mean ICIQ‐SF scores were 5.37 (95% confidence interval [CI] 3.71–7.03) and 5.66 (95% CI 4.05–7.27) for the intervention and control groups, respectively (P = 0.8). There were no statistically significant differences in any of the remaining outcomes. However, the continence rate was higher in the intervention group at 6 months (63% vs 44%, P = 0.09). Conclusions: Intraoperative nerve monitoring did not result in better functional outcomes following UNS or NNS RARP. Larger studies are needed to explore if ProPep can reduce the time to continence after RARP. [ABSTRACT FROM AUTHOR]

Thyrotropin-receptor antibodies (TRAb) are used to diagnose Graves’ hyperthyroidism in pregnant women. Bioassays provide a measure of thyrotropin-receptor stimulatory antibodies (TSI) specifically. The objective was to measure TSI in pregnant women for establishment of a pregnancy-specific cut-off and comparison with immunoassay measurements of TRAb.The retrospective Danish study was performed within the North Denmark Region Pregnancy Cohort (2011–2015) that includes stored biobank samples from early pregnancy (median week 10) with immunoassay measurements of thyroid function parameters and TRAb. TSI were measured in the same samples using the Turbo TSI bioassay (Quidel/Ortho-Clinical Diagnostics) with a recommended cut-off of 0.0241 IU/L in non-pregnant adults. A pregnancy-specific TSI cut-off (95-percentile) was established using Regression on Order Statistics.The established TSI cut-off was 0.0418 IU/L (95 % CI: 0.0417–0.0419). Among women with early pregnancy hyperthyroidism (n=438), 43 women (9.8 %) were TSI positive using the established cut-off, and these women had lower TSH (median 0.008 mIU/L) compared to women with TSI levels below 0.0241 (median TSH 0.040 mIU/L) or in the range from 0.0241 to 0.0418 (median TSH 0.033 mIU/L). Among the 438 women with early pregnancy hyperthyroidism, 22 women were positive for TSI and TRAb, 388 were negative for both, and 28 women were positive for either TSI or TRAb.This is the first study on TSI measurements in a large cohort of early pregnant women. A pregnancy-specific cut-off for TSI was established and agreement in the classification with immunoassay measurements of TRAb was seen in 94 % of cases. [ABSTRACT FROM AUTHOR]

Objectives: To test whether there is a difference in professional and patient‐reported outcome measures (PROM) after single‐crown restoration supported by short implants (SI) (6 mm) compared with standard length implants (SLI) (13 mm) in conjunction with maxillary sinus floor augmentation (MSFA) after 1 year of functional implant loading. Material and Methods: Forty patients were randomly allocated to SI or SLI/MSFA. PROM included Oral Health Impact Profile (OHIP‐14) questionnaire and subjective assessment of the peri‐implant soft tissue (A), implant crown (B), implant function (C) and overall implant treatment outcome (D) using visual analogue scale (VAS). Professional assessment included pink aesthetic score (PES) and white aesthetic score (WES). Results: No significant differences in professional or PROM between the two treatment modalities were revealed at any time point (p >.05). OHIP‐14 score decreased at baseline and 1 year after functional implant loading compared with preoperative measurements indicating improved quality of life with both treatment modalities. The 1‐year mean VAS score was 9.4 (A), 9.3 (B), 9.6 (C) and 9.3 (D) for SI compared with 9.3 (A), 9.6 (B), 9.7 (C) and 9.2 (D) for SLI. The 1‐year mean PES/WES scores were 11.3 and 8.1 for SI compared with 11.2 and 8.1 for SLI/MSFA. Conclusions: Prosthetic rehabilitation of the posterior part of the maxilla with SI or SLI/MSFA revealed no significant differences in professional and PROM after 1 year of implant loading. [ABSTRACT FROM AUTHOR]

Objective: Test the hypothesis of no difference in bone regeneration after maxillary sinus floor augmentation (MSFA) with different ratios of iliac or mandibular autogenous bone (AB) graft and deproteinized bovine bone mineral (DBBM). Materials and Methods: Forty minipigs were randomly allocated to bilateral MSFA using: (A) 100% AB, (B) 75% AB and 25% DBBM, (C) 50% AB and 50% DBBM, (D) 25% AB and 75% DBBM, or (E) 100% DBBM. The animals were euthanized 12 weeks after surgery. Percentage of bone, non‐mineralized tissue, and residual DBBM were estimated by histomorphometric analysis in a randomly selected region of interest and summarized as mean percentage with 95% confidence interval (CI). Results: Mean percentage of bone following MSFA with iliac or mandibular AB graft was: (A) 55.5% and 64.2%, (B) 60.3% and 61.6%, (C) 54.4% and 52.1%, (D) 51.8% and 53.1%, and (E) 47.6%, respectively. There was a significant trend toward a higher percentage of bone, with a higher ratio of AB within the graft (p <.01), regardless of the origin of AB graft (iliac or mandible). Conclusions: The hypothesis was rejected since percentage of bone was significantly increased with larger proportions of AB within the graft. Consequently, AB or a mixture of AB and diminutive quantities of DBBM seem to be the preferred graft for MSFA based solely on histomorphometric assessment. However, it should be emphasized that newly formed bone and residual AB graft particles could not be distinguished by the applied histologic procedure. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness and impact of low‐pressure pneumoperitoneum (Pnp) on postoperative quality of recovery (QoR) and surgical workspace (SWS) in patients with prostate cancer undergoing robot‐assisted radical prostatectomy (RARP). Patients and Methods: A randomised, triple‐blinded trial was conducted in a single centre in Denmark from March 2021 to January 2022. A total of 98 patients with prostate cancer undergoing RARP were randomly assigned to either low‐pressure Pnp (7 mmHg) or standard‐pressure Pnp (12 mmHg). Co‐primary outcomes were postoperative QoR measured via the QoR‐15 questionnaire on postoperative Day 1 (POD1), POD3, POD14, and POD30, and SWS assessed intraoperatively by a blinded assessor (surgeon) via a validated SWS scale. Data analysis was performed according to the intention‐to‐treat principle. Results: Patients who underwent RARP at low Pnp pressure demonstrated better postoperative QoR on POD1 (mean difference = 10, 95% confidence interval [CI] 4.4–15.5), but no significant differences were observed in the SWS (mean difference = 0.25, 95% CI −0.02 to 0.54). Patients allocated to low‐pressure Pnp experienced statistically higher blood loss than those in the standard‐pressure Pnp group (mean difference = 67 mL, P = 0.01). Domain analysis revealed significant improvements in pain (P = 0.001), physical comfort (P = 0.007), and emotional state (P = 0.006) for patients with low‐pressure Pnp. This trial was registered at ClinicalTrials.gov, NCT04755452, on 16/02/2021. Conclusion: Performing RARP at low Pnp pressure is feasible without compromising the SWS and improves postoperative QoR, including pain, physical comfort, and emotional state, compared to the standard pressure. [ABSTRACT FROM AUTHOR]

To evaluate the effects of 20 weeks of home-based isometric handgrip training (IHT) compared with usual care on systolic blood pressure (SBP) in adults. This was a randomised, controlled, assessor-blinded trial. Participants were randomised to either IHT (intervention group) or usual care (control group). Participants randomised to the intervention group performed a session of 16 min of effective workout home-based IHT three times per week for 20 weeks. Participants randomised to the control group were asked to continue their daily activities as usual. The primary outcome was the difference in SBP between groups over 20 weeks. Secondary outcomes were diastolic blood pressure, heart rate, handgrip strength, and self-administered home blood pressure measures. Forty-eight adults (mean [SD] age, 64 [8] years) were included in this trial. The adjusted between-group mean difference in SBP was 8.12 mmHg (95% CI 0.24 to 16.01, p = 0.04) – favouring the usual care group. No differences between groups were found in any of the home blood pressure measurements. This trial showed that 20 weeks of home-based isometric handgrip training was not superior compared to the usual care in lowering SBP. [ABSTRACT FROM AUTHOR]

Introduction: According to a precautionary principle, it is recommended that pregnant women and women trying to conceive abstain from alcohol consumption. In this dose–response meta‐analysis, we aimed to examine the association between alcohol consumption and binge drinking and the risk of miscarriage in the first and second trimesters. Material and methods: The literature search was conducted in MEDLINE, Embase and the Cochrane Library in May 2022, without any language, geographic or time limitations. Cohort or case–control studies reporting dose‐specific effects adjusting for maternal age and using separate risk assessments for first‐ and second‐trimester miscarriages were included. Study quality was assessed using the Newcastle–Ottawa Scale. This study is registered with PROSPERO, registration number CRD42020221070. Results: A total of 2124 articles were identified. Five articles met the inclusion criteria. Adjusted data from 153 619 women were included in the first‐trimester analysis and data from 458 154 women in the second‐trimester analysis. In the first and second trimesters, the risk of miscarriage increased by 7% (odds ratio [OR] 1.07, 95% confidence interval [CI] 0.96–1.20) and 3% (OR 1.03, 95% CI 0.99–1.08) for each additional drink per week, respectively, but not to a statistically significant degree. One article regarding binge drinking and the risk of miscarriage was found, which revealed no association between the variables in either the first or second trimester (OR 0.84 [95% CI 0.62–1.14] and OR 1.04 [95% CI 0.78–1.38]). Conclusions: This meta‐analysis revealed no dose‐dependent association between miscarriage risk and alcohol consumption, but further focused research is recommended. The research gap regarding miscarriage and binge drinking needs further investigation. [ABSTRACT FROM AUTHOR]

The extent to which Danish gender diverse individuals (GDI) self-medicate was unknown, so we have investigated the prevalence of the phenomenon in a clinical sample and a survey sample. Our objective was, moreover, to examine possible significant differences between the subgroup of GDI that seek assessment and gender-affirming treatment, and the general population of GDI, of whom some might seek treatment, and some might not. Data regarding the clinical sample (CS) were collected from records of all the GDI treated at our clinic in 2017. The survey sample (SS) comprised the GDI who answered the questions about self-medication in a larger group of respondents to an internet-based survey carried out in 2019. Our CS included data collected from 115 individuals, while the number of individuals in the SS was 171. The rates of self-medication were 19.1% in the CS and 22.2% in the SS, with no statistically significant difference found. Among individuals who self-medicated, there was a majority of assigned male at birth (AMAB) in both samples (72.7% in CS v. 92.1% in SS). No statistically significant differences were found in self-medication stratified by assigned sex at birth. There was a statistically significant difference concerning the source of self-medication. 9.5% in the CS v. 76.3% in the SS procured self-medication from the internet. Other common sources were foreign clinics, another GDI and the pharmacy. Within the SS, 18.9% of those who self-medicated hadn´t gotten assessment for Gender Incongruence or any previously used diagnostic category. Only 3.8% of those who didn´t self-medicate hadn´t gotten the assessment either. This difference was statistically relevant. Around 93% of both subgroups reported to have completed the diagnostic assessment. While there are very few differences between the two samples, around a fifth of the GDI included have self-medicated. Overall, self-medication reflects an unmet need in the healthcare system. None [ABSTRACT FROM AUTHOR]

In this retrospective cohort study, we evaluated the level of biomarkers of inflammation like phagocyte-related S100 proteins and a panel of cytokines in 128 children with pre-B ALL and 22 with T-ALL. The biomarkers were evaluated at diagnosis and during antileukemic therapy (day 29 and after six months) and we evaluated their correlation with basic laboratory values. Further, for the children with pre-B ALL, we evaluated whether the biomarkers could predict the outcome of ALL expressed as minimal residual disease (MRD), relapse, and death. The levels of S100A9, S100A12, IL-1beta, IL-12p70, IL-13, IL-17, IL-18, and MPO serum levels increased significantly as chemotherapy was initiated. The difference was most pronounced for S100A9 and S100A12, which had strong positive correlations with the neutrophil counts. In contrast, TNF-alpha, IL-6, IL-10, CCL-2, MMP-3, and CD25 serum levels decreased after chemotherapy. Although none of these biomarkers appear to be an independent predictor of outcomes, in predictive models with MRD as the outcome, AUC increased from 76% (95% CI 68–84%) when using initial risk group stratification alone to 83% (95% CI 73–91%) in a multivariate predictive model including initial risk group stratification and the biomarkers S100A12, TNF-alpha, and IL-10. [ABSTRACT FROM AUTHOR]

Historically in research on gender diverse individuals (GDI), the focus has mostly been put on assigned sex at birth (ASAB) as variable. We wanted to study the possible transition trajectories (TT) of self-identified GDI and to investigate any statistically significant differences (SSD) that might be found, based on the self-defined gender identity (GId). Our study was completed through an anonymous online survey based on an INSERM study (2011), which was developed internationally in six countries. The questionnaire comprises questions regarding the socio-demographic characteristics of the respondents and several other aspects of their lives, among which some concern possible gender affirming interventions, the person has undertaken or plans. Based on the answers to an open-ended question regarding self-definition of GId, our respondents (N=479) were divided into GId-categories: Man, Woman, Trans Man, Trans Woman, Nonbinary, Other GId. When comparing TT based on ASAB, we only found a SSD regarding previous or planned top surgery (p-value 0.0). When analyzing TT based on GId, we found several SSDs regarding application for change of legal gender, previous assessment for Gender Incongruence, previous hormonal treatment, previous or planned top surgery, planned bottom surgery, including planned removal of the gonads (all p-values are 0.0). Furthermore, we found a SSD regarding planned phalloplasty between the group of respondents identifying as Man and those identifying as Trans Man.We moreover found several SSDs regarding application for change of legal gender, previous and planned assessment for Gender Incongruence, previous and planned hormonal treatment (p-value ≤ 0.1) between the group of respondents identifying as Woman and those identifying as Trans Woman. It is, based on our results, relevant to include the self-defined gender identity in the investigation of transition trajectories, and in general in transgender research, policy and healthcare, as it provides a fuller, more nuanced picture of the broad spectrum of gender diversity. None [ABSTRACT FROM AUTHOR]

Historically in research on gender diverse individuals (GDI), the focus has mostly been put on assigned sex at birth (ASAB) as variable. We wanted to study the possible transition trajectories (TT) of self-identified GDI and to investigate any statistically significant differences (SSD) that might be found, based on the self-defined gender identity (GId). Our study was completed through an anonymous online survey based on an INSERM study (2011), which was developed internationally in six countries. The questionnaire comprises questions regarding the socio-demographic characteristics of the respondents and several other aspects of their lives, among which some concern possible gender affirming interventions, the person has undertaken or plans. Based on the answers to an open-ended question regarding self-definition of GId, our respondents (N=479) were divided into GId-categories: Man, Woman, Trans Man, Trans Woman, Nonbinary, Other GId. When comparing TT based on ASAB, we only found a SSD regarding previous or planned top surgery (p-value 0.0). When analyzing TT based on GId, we found several SSDs regarding application for change of legal gender, previous assessment for Gender Incongruence, previous hormonal treatment, previous or planned top surgery, planned bottom surgery, including planned removal of the gonads (all p-values are 0.0). Furthermore, we found a SSD regarding planned phalloplasty between the group of respondents identifying as Man and those identifying as Trans Man.We moreover found several SSDs regarding application for change of legal gender, previous and planned assessment for Gender Incongruence, previous and planned hormonal treatment (p-value ≤ 0.1) between the group of respondents identifying as Woman and those identifying as Trans Woman. It is, based on our results, relevant to include the self-defined gender identity in the investigation of transition trajectories, and in general in transgender research, policy and healthcare, as it provides a fuller, more nuanced picture of the broad spectrum of gender diversity. None [ABSTRACT FROM AUTHOR]

In direct comparison, microdissection testicular sperm extraction (mTESE) gives a higher sperm retrieval rate than multiple needle-pass testicular sperm aspiration. Patients should be informed about the higher risk of surgical complications and potential testosterone deficiency after mTESE. Surgical extraction of testicular spermatozoa is needed in men with nonobstructive azoospermia (NOA) who wish to become biological fathers. Based on available uncontrolled studies with unspecific patient selection, microdissection testicular sperm extraction (mTESE), having a sperm retrieval rate (SRR) of 50%, is considered the most efficient sperm retrieval procedure. However, no randomized clinical trials for comparison of different sperm retrieval procedures exist. Testicular sperm aspiration (TESA) is simple and commonly used, and we hypothesized that this technique using multiple needle passes would give similar SRRs to mTESE. To compare mTESE and multiple needle-pass TESA in men with NOA. A randomized clinical trial was performed between June 2017 and April 2021, with inclusion of 100 men with NOA from four centers in Denmark and Sweden. All participants received treatment at the same institution. Participants were randomized to mTESE (n = 49) or multiple needle-pass TESA (n = 51). Patients with failed multiple needle-pass TESA proceeded directly to salvage mTESE. The primary outcome was SRR. Secondary outcomes included complications and changes in reproductive hormones after surgery. Spermatozoa were retrieved in 21/49 (43%) men after mTESE and in 11/51 (22%) men after multiple needle-pass TESA (rate difference –0.21; 95% confidence interval –0.39 to –0.03; p = 0.02). The combined SRR for multiple needle-pass TESA + salvage mTESE was 15/51 (29%). No complications occurred after multiple needle-pass TESA only, while 5/89 (6%) men having mTESE experienced a complication requiring surgical intervention. Overall, no statistically significant differences in reproductive hormones were observed between groups after 6 mo. Limitations include the low number of patients in secondary outcome data. In direct comparison, SRR was higher in mTESE than in multiple needle-pass TESA. Men with azoospermia need surgical extraction of spermatozoa to become biological fathers. In this randomized trial, we compared two surgeries (microdissection testicular sperm extraction [mTESE] and testicular sperm aspiration [TESA]) and found that mTESE gives a higher sperm retrieval rate than multiple needle-pass TESA. [ABSTRACT FROM AUTHOR]

Introduction: Comparing imaging examinations with those previously obtained is considered mandatory in imaging guidelines. To our knowledge, no studies are available on neither the influence, nor the sequence, of prior imaging and reports on diagnostic accuracy using biopsy as the reference standard. Such data are important to minimize diagnostic errors and to improve the preparation of diagnostic imaging guidelines. The aim of our study was to provide such data. Materials and methods: A retrospective cohort of 216 consecutive skeletal biopsies from patients with at least 2 different imaging modalities (X-ray, CT and MRI) performed within 6 months of biopsy was identified. The diagnostic accuracy of the individual imaging modality was assessed. Finally, the possible influence of the sequence of imaging modalities was investigated. Results: No significant difference in the accuracy of the imaging modalities was shown, being preceded by another imaging modality or not. However, the sequence analyses indicate sequential biases, particularly if MRI was the first imaging modality. Conclusion: The sequence of the imaging modalities seems to influence the diagnostic accuracy against a pathology reference standard. Further studies are needed to establish evidence-based guidelines for the strategy of using previous imaging and reports to improve diagnostic accuracy. [ABSTRACT FROM AUTHOR]

Background: Alcohol abuse may be elicited by psychological problems and can influence physicians' health and patient safety. To act on it, we need knowledge on the prevalence of the disorder and its associations with psychological factors and physicians' well-being. The aim of this study was to explore whether burnout and alexithymia are associated with risky alcohol consumption in physicians and whether burnout mediates the association between alexithymia and risky alcohol consumption.Methods: In this cross-sectional study, 4,000 randomly selected physicians received an electronic questionnaire by email containing the Alcohol Use Disorders Identification Test (AUDIT), the Maslach Burnout Inventory Human-Services-Survey (MBI-HSS) and the Toronto Alexithymia Scale (TAS-20). A total of 1,841 physicians completed the questionnaire (46%).Results: 18.8% reached the criteria for risky alcohol consumption. The likelihood of having risky alcohol consumption was associated with high levels of alexithymia (OR=1.93, 95%CI=1.37-2.74, P<0.001). Moreover, risky alcohol consumption was associated with burnout (OR=1.86, 95%CI=1.13-3.05, P<0.014) and each individual burnout dimension: emotional exhaustion (OR=1.89, 95%CI=1.33-2.69, P<0.001), depersonalisation (OR=2.23, 95%CI=1.53-3.25, P<0.001) and low levels of personal accomplishment (OR=1.66, 95%CI=1.14-2.41, P=0.008). Mediation analysis suggested that the association between alexithymia and risky alcohol consumption was partially mediated through depersonalisation.Conclusions: The results emphasize a need for enhancing emotional self-awareness in physicians as psychological traits, work-pressure and alcohol dependence might be self-reinforcing aspects for the individual physician. As alcohol dependence and burnout may have consequences for patient safety separately, the aggregated influence of these factors has to be examined. [ABSTRACT FROM AUTHOR]

Background: Little is known about the influence of exogenous insulin and actual glucose levels on the release of endogenous insulin in insulin-treated type 2 diabetes mellitus (T2DM) patients. This study investigated the interaction among serum endogenous insulin (s-EI), serum exogenous insulin aspart (s-IAsp), and blood glucose levels in an experimental short-term crossover design. Study Design and Methods: Eight T2DM patients (63.52 years old; range, 49-69 years; mean body mass index, 28.8±3.8 kg/m2) were randomized to treatment with individual fixed doses of insulin aspart (0.5-1.5 IU/h) as a continuous subcutaneous insulin infusion (CSII) during a 10-h period on two occasions with different duration of hyperglycemia: (1) transient hyperglycemia for 2 h (visit TH) and (2) continuous hyperglycemia for 12 h (visit CH). Results: During steady state the variances of plasma glucose (p-glucose), s-IAsp, and s-EI were equal within visit TH and within visit CH, but variances were significantly higher during visit CH compared with visit TH. The s-IAsp reached lower levels at visit CH compared with visit TH (test for slope=1, P=0.005). The s-EI depended on p-glucose in a nonlinear fashion during the first 100 min of both visits when s-IAsp was undetectable (adjusted R2=0.9). A complex but statistically significant interaction among s-IAsp, s-EI, p-glucose, and patients was observed during measurable s-IAsp levels (adjusted R2=0.70). Conclusions: Endogenous and exogenous insulin showed higher variation during continuous hyperglycemia. Significantly lower levels of exogenous insulin were observed following CSII during continuous hyperglycemia compared with transient hyperglycemia. Endogenous insulin levels could in a complex way be explained by an individual interaction among p-glucose and serum exogenous insulin, if present. [ABSTRACT FROM AUTHOR]

The developmental speed of new antimicrobials does not meet the emergence of multidrug-resistant bacteria sufficiently. A potential shortcut is assessing the antimicrobial activity of already approved drugs. Intrudingly, the antibacterial action of glatiramer acetate (GA) has recently been discovered. GA is a well-known and safe immunomodulatory drug particular effective against Gram-negative bacteria, which disrupts biological membranes by resembling the activity of antimicrobial peptides. Thus, GA can potentially be included in treatment strategies used to combat infections caused by multidrug-resistant Gram-negatives. One potential application is chronic respiratory infections caused by Pseudomonas aeruginosa, however the safety of GA inhalation has never been assessed. Here, the safety of inhaling nebulized GA is evaluated in a preclinical pig model. The potential side effects, i.e., bronchoconstriction, respiratory tract symptoms and systemic- and local inflammation were assessed by ventilator monitoring, clinical observation, biochemistry, flowcytometry, and histopathology. No signs of bronchoconstriction assessed by increased airway peak pressure, Ppeak, or decreased oxygen pressure were observed. Also, there were no signs of local inflammation in the final histopathology examination of the pulmonary tissue. As we did not observe any potential pulmonary side effects of inhaled GA, our preliminary results suggest that GA inhalation is safe and potentially can be a part of the treatment strategy targeting chronic lung infections caused by multidrug-resistant Gram-negative bacteria. [ABSTRACT FROM AUTHOR]

Objective: To study cardiometabolic risk-factor trajectories (in terms of levels and changes over time) preceding diabetic polyneuropathy (DPN) 13 years after a screen-detected diagnosis of type 2 diabetes.Research Design and Methods: We clinically diagnosed DPN in a nested case-control study of 452 people in the Danish arm of the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION). By linear regression models, we estimated preceding risk-factor trajectories during 13 years. Risk of DPN was estimated by multivariate logistic regression models of each individual's risk-factor trajectory intercept and slope adjusting for sex, age, diabetes duration, height, and trial randomization group.Results: Higher baseline levels of HbA1c (odds ratio [OR] 1.76 [95% CI 1.37; 2.27] and OR 1.68 [95% CI 1.33; 2.12] per 1% and 10 mmol/mol, respectively) and steeper increases in HbA1c over time (OR 1.66 [95% CI 1.21; 2.28] and OR 1.59 [95% CI 1.19; 2.12] per 1% and 10 mmol/mol increase during 10 years, respectively) were associated with DPN. Higher baseline levels of weight, waist circumference, and BMI were associated with DPN (OR 1.20 [95% CI 1.10; 1.31] per 5 kg, OR 1.27 [95% CI 1.13; 1.43] per 5 cm, and OR 1.24 [95% CI 1.12; 1.38] per 2 kg/m2, respectively).Conclusions: Both higher levels and slopes of HbA1c trajectories were associated with DPN after 13 years. Our findings indicate that the rate of HbA1c increase affects the development of DPN over and above the effect of the HbA1c level. Furthermore, this study supports obesity as a risk factor for DPN. [ABSTRACT FROM AUTHOR]

Sore throat (POST) and hoarseness (PH) are common complaints after endotracheal intubation (EI). The aim of this study was to investigate whether tube size impacts the experiences of POST and PH after EI in patients undergoing elective surgery, as well as to document a possible role of gender. This randomised, controlled, blinded study was conducted at Aalborg University Hospital, Thisted, Denmark or North Denmark Regional Hospital, Denmark. A total of 236 patients (53.4% female, mean age 50.9 years (SD 14.0)) were enrolled from the departments of gynaecology, parenchyma and orthopaedics. The patients were randomised to a tube size of 8.0 or 7.0 for males and 7.0 or 6.0 for females. Tube sizes were known to the anaesthesia staff but blinded for patients, researchers and staff at the postoperative care unit. POST and/or PH was reported 30–60 min before anaesthesia, at 30 min and at 2, 5, 12, 24, 48, 72 and 96 h after anaesthesia. Both female and male patients experienced significantly lower levels of POST and PH after intubation with the smallest tube size. This study demonstrates that a smaller size of tube results in a reduction in POST and PH after EI for both male and female patients. [ABSTRACT FROM AUTHOR]