National Quality Register Research Articles

Obstetric and Perinatal Outcomes of Singleton Births Following Single- vs Double-Embryo Transfer in Sweden

Pregnancies resulting from assisted reproductive technology are associated with an increased risk of adverse perinatal outcomes compared with those following natural conception. Previous studies have shown an association of pregnancies resulting from transfer of multiple embryos with these negative findings. To determine the risk for adverse outcomes in singletons conceived through assisted reproduction using double-embryo transfer (DET) vs single-embryo transfer (SET). This cohort study used data from women who achieved singleton deliveries after SET or DET in Sweden between 2007 and 2017 as recorded in the National Quality Registry for Assisted Reproduction. All embryo transfers, at cleavage or blastocyst stage, replaced in fresh or frozen treatment cycles were included. Data on obstetric and neonatal outcomes were retrieved by linkage to the National Medical Birth Register. Naturally conceived singletons were included as a reference group. Data were analyzed between September 2021 and August 2022. Double-embryo transfer leading to singleton birth. Relative risk ratios or odds ratios (ORs) and absolute risk differences (ARDs) in percentage points with 95% CIs were calculated for obstetric and perinatal outcomes in singleton births conceived using DET vs SET. Among 1 115 863 singleton births, 30 713 singletons were born after SET and 5123 after DET. A higher risk of neonatal death was found in singletons after DET vs SET (OR, 2.67 [95% CI, 1.28-5.55]; ARD, 0.2 percentage points [95% CI, 0.0-0.4 percentage points]). In frozen embryo transfers, DET was associated with a higher risk of low birth weight (OR, 1.64 [95% CI, 1.19-2.25]; ARD, 2.0 percentage points [95% CI, 0.5-3.5 percentage points]). Among blastocyst transfers, DET was associated with very preterm birth (relative risk ratio, 2.64 [95% CI, 1.50-4.63]; ARD, 1.8 percentage points [95% CI, 0.3-3.4 percentage points]) and low birth weight (OR, 1.83 [95% CI, 1.29-2.60]; ARD, 3.2 percentage points [95% CI, 0.9-5.5 percentage points]). These results indicate a higher risk of adverse outcomes following DET, even when the result is a singleton birth, vs singletons born after SET. Adverse outcomes were mainly observed in singletons following DET using frozen embryos and blastocysts.

Cohort profile: the Swedish National Quality Register for bipolar disorder(BipoläR)

PurposeThe Swedish National Quality Register for bipolar affective disorder, BipoläR, was established in 2004 to provide nationwide indicators for quality assessment and development in the clinical care of individuals with...

The Collaborative National Quality and Efficacy Registry for Scleroderma: association of medication use on gastrointestinal tract symptoms in early disease and the importance of tobacco cessation.

Systemic Sclerosis (SSc) is frequently associated with gastrointestinal tract (GIT) involvement. The Collaborative National Quality and Efficacy Registry (CONQUER) is a US-based collaborative study collecting longitudinal follow up data on SSc patients with less than 5-years disease duration enrolled at Scleroderma centres of excellence. This manuscript presents the GIT natural history and outcomes in relation to other scleroderma manifestations and medication exposures. CONQUER participants that had completed a minimum of two serial Scleroderma Clinical Trials Consortium GIT Questionnaires (GIT 2.0) were included in this analysis. Patients were categorised by total GIT 2.0 severity at baseline, and by category change: none-to-mild (0.49); moderate (0.50-1.00), and severe-to-very severe (1.01-3.00) at the subsequent visit. Based on this data, four groups were identified: none-to-mild with no change, moderate-to-severe with no change, improvement, or worsening. Clinical features and medications, categorised as gastrointestinal tract targeted therapy, anti-fibrotic, immunosuppression, or immunomodulatory drugs, were recorded. Analysis included a proportional odds modelaccounting for linear and mixed effects of described variables. 415 enrolled CONQUER participants met project inclusion criteria. Most participants had stable mild GIT symptoms at baseline and were on immunomodulatory and anti-reflux therapy. In most patients, anti-reflux medication and immunosuppression initiation preceded the baseline visit, whereas anti-fibrotic initiation occurred at or after the baseline visit. In the proportional odds model, worsening GIT score at the follow-up visit was associated with current tobacco use (odds ratio: 3.48 (1.22, 9.98, p 0.020). This report from the CONQUER cohort, suggests that most patients with early SSc have stable and mild GIT disease. Closer follow-up was associated with milder, stable GIT symptoms. There was no clear association between immunosuppression or anti-fibrotic use and severity of GIT symptoms. However, active tobacco use was associated with worse GIT symptoms, highlighting the importance of smoking cessation counselling in this population.

Between-hospital variation in time to glioblastoma surgery: a report from the Quality Registry Neuro Surgery in the Netherlands.

Patients with glioblastoma are often scheduled for urgent elective surgery. Currently, the impact of the waiting period until glioblastoma surgery is undetermined. In this national quality registry study, the authors determined the wait times until surgery for patients with glioblastoma, the risk factors associated with wait times, and the risk-standardized variation in time to surgery between Dutch hospitals. The associations between time to surgery and patient outcomes were also explored. Data from all 4589 patients who underwent first-time glioblastoma surgery between 2014 and 2019 in the Netherlands were collected by 13 hospitals in the Quality Registry Neuro Surgery. Time to surgery comprised 1) the time from first MR scan to surgery (MTS), and 2) the time from first neurosurgical consultation to surgery (CTS). Long MTS was defined as more than 21 days and long CTS as more than 14 days. Potential risk factors were analyzed in multivariable logistic regression models. The standardized rate of long time to surgery was analyzed using funnel plots. Patient outcomes including Karnofsky Performance Scale (KPS) score change, complications, and survival were analyzed by multivariable logistic regression and proportional hazards models. The median overall MTS and CTS were 18 and 9 days, respectively. Overall, 2576 patients (56%) had an MTS within 3 weeks and 3069 (67%) had a CTS within 2 weeks. Long MTS was significantly associated with older age, higher preoperative KPS score, higher American Society of Anesthesiologists comorbidity class, season, lower hospital case volume, university affiliation, and resection. Long CTS was significantly associated with higher baseline KPS score, university affiliation, resection, more recent year of treatment, and season. In funnel plots, considerable practice variation was observed between hospitals in patients with long times to surgery. Fewer patients with KPS score improvement were observed after a long time until resection. Long CTS was associated with longer survival. Complications and KPS score decline were not associated with time to surgery. Considerable between-hospital variation among Dutch hospitals was observed in the time to glioblastoma surgery. A long time to resection impeded KPS score improvement, and therefore, patients who may improve should be identified for more urgent resection. Longer survival was observed in patients selected for longer time until surgery after neurosurgical consultation (CTS).

A study comparing outcomes between obese and nonobese patients with lumbar disc herniation undergoing surgery: a study of the Swedish National Quality Registry of 9979 patients

BackgroundThis study aimed to evaluate whether an increasing grade of obesity is associated with inferior outcomes after lumbar disc herniation (LDH) surgery.MethodsWe retrieved data from the Swedish register for spine surgery regarding patients aged 20–64 who underwent LDH surgery from 2006–2016 and had preoperative and one-year postoperative data. A total of 4156 patients were normal weight, 4063 were overweight, 1384 had class I obesity, 317 had class II obesity and 59 had class III obesity (“morbid obesity”). Data included patient satisfaction, improvement in leg pain (assessed using the National Rating Scale; NRS; rating 0–10), disability (assessed using the Oswestry Disability Index; ODI; rating 0–100) and complications.ResultsAt one year postsurgery, 80% of normal-weight patients, 77% of overweight patients and 74% of obese patients (class I-III evaluated together) were satisfied (p < 0.001) [75%, 71%, 75% in obesity classes I, II, and III, respectively (p = 0.43)]. On average, all groups improved by more than the minimal clinically important difference (MCID) in both NRS leg pain (> 3.5) and ODI (> 20). NRS leg pain improved by 4.8 in normal weight patients (95% CI 4.7–4.9), by 4.5 in overweight patients (4.5–4.6) and by 4.3 in obese patients (4.2–4.4) (p < 0.001) [4.4 (4.3–4.6), 3.8 (3.5–4.1) and 4.6 (3.9–5.3) in obesity classes I, II, and III, respectively (p < 0.001)]. The ODI improved by 30 in normal weight patients (30–31), by 29 in overweight patients (28–29) and by 26 in obese patients (25–27) (p < 0.001) [29 (28–29), 25 (22–27) and 27 (22–32) in obesity classes I, II, and III, respectively (p < 0.01)]. A total of 3.0% of normal-weight patients, 3.9% of overweight patients and 3.9% of obese patients suffered complications (p = 0.047) [3.8%, 4.4%, 3.5% in obesity classes I, II, and III, respectively (p = 0.90)].ConclusionsLDH surgery is also generally associated with favourable outcomes and few complications in patients with morbid obesity.

Clinical routines for diabetes screening and treatment in cardiac rehabilitation improves detection and treatment of diabetes mellitus in patients with myocardial infarction

Abstract Background Patients with myocardial infarction (MI) have a high prevalence of diabetes mellitus (DM). Prognosis in patients with MI and DM is substantially worse than for those without DM. An unacceptably high proportion of patients with DM remain both undiagnosed and undertreated despite follow-up at cardiac rehabilitation (CR) centres. Purpose Using nationwide survey and registry data to investigate associations of clinical routines for DM screening and treatment at CR centres in Sweden with detection and treatment of DM at one-year post-MI. Methods Data on CR clinical routines were derived from the Perfect-CR survey, evaluating structures and follow-up processes at CR centres in Sweden (n=78). The response rate was 100% and missing data was minimal. Clinical routines for DM screening and treatment during CR (exposures) included the following: 1) laboratory assessments of fasting glucose and/or HbA1c as a part of initial patient assessment by a nurse, 2) routine use of oral glucose tolerance test (OGTT), 3) joint case rounds with diabetologists, and 4) whether diabetes medication is adjusted by cardiologists. Patient baseline and outcome data was derived from the national quality registry SWEDEHEART (n=7549). Primary outcome was DM incidence at one-year post-MI. Secondary outcome was the proportion of patients receiving diabetes medication other than insulin (secondary outcome). The association between exposures (for each clinical routine and cumulatively [0–4 work routines]) and outcomes was estimated using unadjusted and adjusted logistic regression, adjusting for relevant covariates. Results Number (%) of CR centres applying each of the clinical routines is shown in Table 1. The most common routine applied was fasting glucose and/or HbA1c being routinely evaluated at initial patient assessment (n=48 (62%)), while the least common was CR centres having joint case rounds with diabetologists (n=7 (9%)). Twenty (26%) CR centres did not apply any of the clinical routines while 7 (9%) centres applied 3 or 4 routines. Unadjusted and adjusted odds ratios (OR) with 95% confidence intervals (CI) for incident DM are shown in Figure 1. Compared to not applying any routines, 1) applying one or more routines was positively associated higher DM incidence at one-year post-MI (p for trend in unadjusted and adjusted models &amp;lt;0.001. Figure 1), and 2) at centres where all four working routines were applied, the odds for patients being treated with diabetes medication was significantly higher (crude OR 2.37 [1.80–3.13], adjusted OR 1.78 [1.19–2.66]). Conclusion Applying structured clinical routines for DM screening and treatment within CR can improve detection and treatment of DM in patients with MI Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): The current study was supported by The Swedish Research Council for Health, Working Life and Welfare (FORTE, grant number 2019-00365); The Swedish Heart and Lung Association (grant number 20190431); The Swedish Heart and Lung Patient Organization; The Swedish Cardiology Society; The faculty of Medicine, Lund University, Sweden; Astra Zeneca; and Amgen.

Oral anticoagulant treatment in patients with atrial fibrillation early after valvular intervention: a nationwide cohort study

Abstract Background Treatment with non-vitamin K oral anticoagulants (NOAC) is the first option for primary prevention of ischaemic stroke in patients with atrial fibrillation (AF). However, there is still an evidence gap regarding efficacy and safety of NOAC in patients with AF and severe valvular heart disease undergoing valvular intervention. Purpose The aim was to evaluate the efficacy and safety of NOAC or no oral anticoagulant (OAC) treatment versus warfarin during the first 3 months after valvular intervention. Methods We used data from the National Quality Register SWEDEHEART and included all patients with AF discharged after surgical valvular intervention with bioprosthesis or valvuloplasty, or transcatheter aortic valve implantation (TAVI) between 2010 and 2016. Outcomes, including the composite of cardiovascular (CV) events (CV death, ischaemic stroke or systemic embolism), major bleeding, and relevant comorbidities and OAC treatment at discharge were collected from the National Patient Register, the Swedish Prescribed Drug Register, and the National Cause of Death Register. The association between exposure (warfarin, NOAC or no OAC) and occurrence of composite CV events and major bleeding was explored using a time-dependent adjusted Cox regression analysis. Results In total, 4730 patients with AF and valvular intervention were included. The cohort had a mean age of 75 years, 35.9% were women and mean CHA2DS2-VASc score was 3.3 (Table 1). The proportion of patients treated with warfarin was higher in patients undergoing surgical valve intervention whereas NOAC was more commonly prescribed to patients treated with TAVI. Rates of composite CV events and major bleeding was similar between patients treated with NOAC versus warfarin. No OAC treatment versus warfarin was associated with higher rate of composite CV event, but with no difference with regard to major bleeding (Table 1). Conclusion A large proportion of patients with AF undergoing valvular intervention was not treated with OAC despite having a high CHA2DS2-VASc score. Also, patients on no OAC versus warfarin had a higher risk of i CV events in the early phase after valvular intervention. The efficacy and safety of NOAC was similar compared to warfarin during the first 3 months after intervention. Treatment with OAC in patients with AF, irrespective of NOAC or warfarin, was associated with improved clinical outcome early after valve intervention. Funding Acknowledgement Type of funding sources: None.

Gender differences in diagnostic tools, medication, time to medication, and nonmotor symptoms in Parkinsonian patients.

Swedish National Quality Registers (NQRs) play an important role in collecting large amounts of diagnosis-specific data, symptoms, and treatments. The subset of data, Parkinson's Registry, has been in use for more than 20 years and represents all counties and hospitals in Sweden where neurological care is provided. To study the differences between genders regarding diagnostic tools, pharmacological interventions, and self-reported symptoms in patients with symptoms originating from basal ganglia disease, either idiopathic or secondary Parkinsonism (PD). PD-diagnosed patients from a mix of urban and rural locations were chosen from the NQR and sorted by gender. Self-reported, first-experienced PD-related symptoms defined the debut point of PD. In all, data from 1,217 patients were analyzed: 502 (41%) females/715 (59%) males. A total of 493 imaging investigations were performed, where of 239 (48% females/52% males) had a CT scan performed, 120 (24% females/29% males) had a dopamine transporter scans, and 134 (23% females/26% males) had a magnetic resonance imaging performed (Fisher's exact test, P = 0.19). The average time in years from symptom onset to start of first treatment, and from first to second added treatment was 2;7/2;9 (females) and 5;1/5;2 (males). Nonmotor symptoms were more prominent among males, especially in memory and gastrointestinal domains, including drooling and obstipation. Significantly more sexual problems were reported from males; 26% versus 7% (Fisher's exact test, P < 0.0001). Differences between genders were identified in this study. Sexual problems and cognitive decline were more frequent among males. More advanced diagnostic imaging techniques were performed among males. The time point for a second added medication was earlier for males than females.

Development and testing of data infrastructure in the American College of Emergency Physicians' Clinical Emergency Data Registry for opioid-related research.

ObjectivePrior research has identified gaps in the capacity of electronic health records (EHRs) to capture the intricacies of opioid‐related conditions. We sought to enhance the opioid data infrastructure within the American College of Emergency Physicians’ Clinical Emergency Data Registry (CEDR), the largest national emergency medicine registry, through data mapping, validity testing, and feasibility assessment.MethodsWe compared the CEDR data dictionary to opioid common data elements identified through prior environmental scans of publicly available data systems and dictionaries used in national informatics and quality measurement of policy initiatives. Validity and feasibility assessments of CEDR opioid‐related data were conducted through the following steps: (1) electronic extraction of CEDR data meeting criteria for an opioid‐related emergency care visit, (2) manual chart review assessing the quality of the extracted data, (3) completion of feasibility scorecards, and (4) qualitative interviews with physician reviewers and informatics personnel.ResultsWe identified several data gaps in the CEDR data dictionary when compared with prior environmental scans including urine drug testing, opioid medication, and social history data elements. Validity testing demonstrated correct or partially correct data for >90% of most extracted CEDR data elements. Factors affecting validity included lack of standardization, data incorrectness, and poor delimitation between emergency department (ED) versus hospital care. Feasibility testing highlighted low‐to‐moderate feasibility of date and social history data elements, significant EHR platform variation, and inconsistency in the extraction of common national data standards (eg, Logical Observation Identifiers Names and Codes, International Classification of Diseases, Tenth Revision codes).ConclusionsWe found that high‐priority data elements needed for opioid‐related research and clinical quality measurement, such as demographics, medications, and diagnoses, are both valid and can be feasibly captured in a national clinical quality registry. Future work should focus on implementing structured data collection tools, such as standardized documentation templates and adhering to data standards within the EHR that would better characterize ED‐specific care for opioid use disorder and related research.

Risk of Hypertensive Disorders in Pregnancy After Fresh and Frozen Embryo Transfer in Assisted Reproduction: A Population-Based Cohort Study With Within-Sibship Analysis.

Frozen embryo transfer (frozen-ET) is increasingly common because of improved cryopreservation methods and elective freezing of all embryos. Frozen-ET is associated with higher risk of hypertensive disorders in pregnancy than both natural conception and fresh embryo transfer (fresh-ET), but whether this is attributable to parental factors or treatment is unknown. Using the Medical Birth Registries of Denmark (1994-2014), Norway, and Sweden (1988-2015), linked to data from national quality registries and databases on assisted reproduction, we designed a population-based cohort study with within-sibship comparison. We included 4 426 691 naturally conceived, 78 300 fresh-ET, and 18 037 frozen-ET singleton pregnancies, of which 33 209 sibships were conceived using different conception methods. Adjusted odds ratios (aOR) of hypertensive disorders in pregnancy for fresh-ET and frozen-ET versus natural conception with 95% CI were estimated using multilevel logistic regression, where random effects provided conventional population-level estimates and fixed effects gave within-sibship estimates. Main models included adjustment for birth year, maternal age, parity, and country. Risk of hypertensive disorders in pregnancy was higher after frozen-ET compared to natural conception, both at population-level (7.4% versus 4.3%, aOR, 1.74 [95% CI, 1.61-1.89]) and within sibships (aOR, 2.02 [95% CI, 1.72-2.39]). For fresh-ET, risk was similar to natural conception, both at population-level (aOR, 1.02 [95% CI, 0.98-1.07]) and within sibships (aOR, 0.99 [95% CI, 0.89-1.09]). Frozen-ET was associated with substantially higher risk of hypertensive disorders in pregnancy, even after accounting for shared parental factors within sibships.

Temporal development in survival, and gender and regional differences in the Swedish population of patients with synchronous and metachronous metastatic colorectal cancer

Background Survival in patients with metastatic colorectal cancer (mCRC) has markedly improved in patients included in clinical trials. In population-based materials, improvements were seen until about a decade ago, but it is unclear if survival has continued to improve. It is also unclear if regional or gender differences exist. Material and methods All patients with mCRC (N = 19,566) in Sweden between 2007 and 2016 were identified from the national quality register, SCRCR, with almost complete coverage. Overall survival (OS) from diagnosis of metastatic disease was calculated in two calendar periods, 2007–2011 and 2012–2016. Differences between groups were compared using Cox regression. Results Median age was 72 years, 55% were males, synchronous presentation was seen in 13,630 patients and metachronous in 5936. In synchronous disease, the primary tumour was removed more often during the first than the second period (51% vs 41%, p < 0.001). Median OS (mOS) was 14.0 months. It was longer in those with metachronous than synchronous disease (17.6 vs 13.1 months, p < 0.001) and in males (15.0 vs 12.8 months, p < 0.001), and markedly influenced by age and primary location. It was longer in patients diagnosed during the second period than during the first (14.9 vs 13.1 months, HR 0.89 (95% CI 0.86–0.92), p < 0.001). This difference was seen in all subgroups according to sex, age, presentation, and sidedness. mOS was about one month shorter in 1/6 healthcare regions, most pronounced during the first period. Differences in median of up to 5 months were seen between the region with the shortest and longest mOS. Conclusions Overall survival in Swedish patients with mCRC has improved during the past decade but is still substantially worse than reported from clinical trials/hospital-based series, reflecting the selection of patients to trials. Regional differences were seen, but they decreased with time. Women did not have a poorer prognosis in multivariable analyses.

Assess and validate predictive performance of models for in-hospital mortality in COVID-19 patients: A retrospective cohort study in the Netherlands comparing the value of registry data with high-granular electronic health records

PurposeTo assess, validate and compare the predictive performance of models for in-hospital mortality of COVID-19 patients admitted to the intensive care unit (ICU) over two different waves of infections. Our models were built with high-granular Electronic Health Records (EHR) data versus less-granular registry data. MethodsObservational study of all COVID-19 patients admitted to 19 Dutch ICUs participating in both the national quality registry National Intensive Care Evaluation (NICE) and the EHR-based Dutch Data Warehouse (hereafter EHR). Multiple models were developed on data from the first 24 h of ICU admissions from February to June 2020 (first COVID-19 wave) and validated on prospective patients admitted to the same ICUs between July and December 2020 (second COVID-19 wave). We assessed model discrimination, calibration, and the degree of relatedness between development and validation population. Coefficients were used to identify relevant risk factors. ResultsA total of 1533 patients from the EHR and 1563 from the registry were included. With high granular EHR data, the average AUROC was 0.69 (standard deviation of 0.05) for the internal validation, and the AUROC was 0.75 for the temporal validation. The registry model achieved an average AUROC of 0.76 (standard deviation of 0.05) in the internal validation and 0.77 in the temporal validation. In the EHR data, age, and respiratory-system related variables were the most important risk factors identified. In the NICE registry data, age and chronic respiratory insufficiency were the most important risk factors. ConclusionIn our study, prognostic models built on less-granular but readily-available registry data had similar performance to models built on high-granular EHR data and showed similar transportability to a prospective COVID-19 population. Future research is needed to verify whether this finding can be confirmed for upcoming waves.

Incidence of self-reported pelvic pain and risk factors for pain 1 year after benign hysterectomy: A register study from the Swedish National Quality Registry for Gynecological Surgery.

The primary aim of this study was to determine the incidence of patient-reported pain 1 year after hysterectomy for benign gynecological conditions in relation to occurrence of preoperative pain. The secondary aim was to analyze clinical risk factors for pain 1 year after the hysterectomy in women with and without preoperatively reported pelvic/lower abdominal pain. This was a historical cohort study using data from the Swedish National Quality Registry for Gynecological Surgery on 16 694 benign hysterectomies. Data were analyzed using multivariable logistic regression models. One year after surgery, 22.4% of women with preoperative pain reported pelvic pain and 7.8% reported de novo pelvic pain. For those with preoperative pain younger age (adjusted odds ratio [aOR] 1.75, 95% confidence interval [CI] 1.38-2.23 and aOR 1.21, 95% CI 1.10-1.34 for women aged <35 and 35-44 years, respectively), not being gainfully employed (aOR 1.43, 95% CI 1.26-1.63), pelvic pain as the main symptom leading to hysterectomy (aOR 1.51, 95% CI 1.19-1.90), endometriosis (aOR 1.18, 95% CI 1.06-1.31), and laparoscopic hysterectomy (aOR 1.30, 95% CI 1.07-1.58), were clinically relevant independent risk factors for pelvic/lower abdominal pain 1 year after surgery, as were postoperative complications within 8 weeks after discharge. Meanwhile, clinically relevant independent risk factors for reporting de novo pain 1 year after surgery were younger age (aOR 2.05, 95% CI 1.08-3.86 and aOR 1.29, 95% CI 1.04-1.60 for women aged <35 and 35-44 years, respectively), and postoperative complications within 8 weeks after discharge. The incidence of pelvic pain and de novo pain 1 year after hysterectomy was relatively high. Women with and without reported preoperative pelvic/lower abdominal pain represented clinically different populations. The risk factors for pelvic pain seemed to differ in these two populations. The differences in risk factors couldbe taken into consideration in the preoperative counseling and in the decision-making concerning method of hysterectomy, provided that large well-designed studies confirm these risk factors.

Association Between Polygenic Risk Scores and Outcome of ECT.

Identifying biomarkers associated with response to electroconvulsive therapy (ECT) may aid clinical decisions. The authors examined whether greater polygenic liabilities for major depressive disorder, bipolar disorder, and schizophrenia are associated with improvement following ECT for a major depressive episode. Between 2013 and 2017, patients who had at least one treatment series recorded in the Swedish National Quality Register for ECT were invited to provide a blood sample for genotyping. The present study included 2,320 participants (median age, 51 years; 62.8% women) who had received an ECT series for a major depressive episode (77.1% unipolar depression), who had a registered treatment outcome, and whose polygenic risk scores (PRSs) could be calculated. Ordinal logistic regression was used to estimate the effect of PRS on Clinical Global Impressions improvement scale (CGI-I) score after each ECT series. Greater PRS for major depressive disorder was significantly associated with less improvement on the CGI-I (odds ratio per standard deviation, 0.89, 95% CI=0.82, 0.96; R2=0.004), and greater PRS for bipolar disorder was associated with greater improvement on the CGI-I (odds ratio per standard deviation, 1.14, 95% CI=1.05, 1.23; R2=0.005) after ECT. PRS for schizophrenia was not associated with improvement. In an overlapping sample (N=1,207) with data on response and remission derived from the self-rated version of the Montgomery-Åsberg Depression Rating Scale, results were similar except that schizophrenia PRS was also associated with remission. Improvement after ECT is associated with polygenic liability for major depressive disorder and bipolar disorder, providing evidence of a genetic component for ECT clinical response. These liabilities may be considered along with clinical predictors in future prediction models of ECT outcomes.

Cohort profile: the Norwegian Registry of Persons Assessed for Cognitive Symptoms (NorCog) – a national research and quality registry with a biomaterial collection

PurposeThe Norwegian Registry of Persons Assessed for Cognitive Symptoms (NorCog) was established to harmonise and improve the quality of diagnostic practice across clinics assessing persons with cognitive symptoms in Norwegian...

Developing and validating a scoring system for measuring frailty in patients with hip fracture: a novel model for predicting short-term postoperative mortality

ObjectivesFrailty is common among patients with hip fracture and may, in part, contribute to the increased risk of mortality and morbidity after hip fracture surgery. This study aimed to develop...

Rate and risk factors for thromboembolism and major bleeding in adults with congenital heart disease taking vitamin K antagonist therapy

BackgroundThe risk of adults with a congenital heart defect (ACHD) developing heart failure, stroke, arrhythmias, and the need for valve replacement is increased compared to healthy peers. Evidence for the use of novel oral anticoagulants (NOAC) in this patient group is still lacking and vitamin K antagonists (VKA) are the primary choice for patients with a mechanical valve. The present aim was to determine the rate of thromboembolic and major bleeding events in ACHD patients on VKA therapy. MethodsThis was a retrospective study on ACHD patients on VKA treatment registered in the National Quality Registry for Congenital Heart Disease, SWEDCON, and Atrial fibrillation and Anticoagulation, AuriculA, from Southern Sweden. Results213 patients were included with a mean age of 50 years (±18) years and a mean follow-up of 6.6 years (±3.3 years), 16% had complex defects and 41% had valvular VKA therapy indication. In total, 34 complications were registered, of which 14 were thromboembolic events and 20 were major bleeding events. The rate of thromboembolism and major bleeding events was 1.0 (95% CI: 0.6–1.6) and 1.4 (95% CI: 0.9–2.2) per 100 patient-years, respectively. Forty-three patients died during the study period. The mortality rate was 3.1 per 100 patient-years (95% CI: 2.2–4.1). ConclusionWe found a low rate of thromboembolic events and major bleeding events for low-moderate risk ACHD patients with good quality of VKA anticoagulation. The target of TTR>65% for ACHD patients is recommended.

Summer is not associated with higher live birth rates in fresh IVF/ICSI cycles: a population-based nationwide registry study.

STUDY QUESTIONIs summer associated with a higher live birth rate after fresh IVF/ICSI?SUMMARY ANSWERThere was no support for a higher live birth rate after fresh IVF/ICSI when treatment was performed during the summer season.WHAT IS KNOWN ALREADYSeasonal variations in human natural conception and birth rates are well described. It has been hypothesized that serum vitamin D, levels of which are associated with sun exposure, may have a role in human natural conception rates. However, the association between seasons and IVF outcomes has not yet been clarified and conflicting reports have been published. Furthermore, it has been suggested that women with normal vitamin D levels have a better pregnancy outcome after ART compared to those with vitamin D insufficiency.STUDY DESIGN, SIZE, DURATIONA nationwide, register-based cohort study including all first-time fresh IVF/ICSI treatments (n = 52 788) leading to oocyte retrieval in Sweden between 2009 and 2018 was carried out.PARTICIPANTS/MATERIALS, SETTING, METHODSAll first-time fresh IVF/ICSI cycles leading to oocyte retrieval were identified in the National Quality Registry of Assisted Reproduction. Data collected included patient characteristics as well as information about the treatment cycle and pregnancy outcome. The patients were divided into season subgroups, (summer, autumn, winter and spring) based on the date of oocyte retrieval. The primary outcome was live birth rate, which was defined as the number of live births per oocyte retrieval and embryo transfer (ET). Other outcomes included clinical pregnancy per ET and miscarriage per clinical pregnancy. Logistic regression with multiple imputation was performed to evaluate whether there was an association between season and IVF/ICSI outcomes, with summer as reference. Adjustments were made for woman’s age, year of treatment, BMI, total FSH/hMG dose, type of treatment, fertilization type, embryonic stage at ET and number of embryos transferred.MAIN RESULTS AND THE ROLE OF CHANCELive birth rate per oocyte retrieval ranged between 24% and 26% among seasons. A significantly higher live birth rate was seen for spring compared with summer, 26% versus 24%, respectively (adjusted odds ratio (OR) 1.08, 95% CI 1.02–1.16, P = 0.02). No significant association was seen when winter and autumn were compared with summer. Live birth rate per ET ranged between 29% and 31% among seasons. A significantly higher live birth rate was seen for spring and autumn compared with summer, at 31% and 31%, respectively versus 29% (adjusted OR 1.08, 95% CI 1.01–1.16, P = 0.04 and adjusted OR 1.09, 95% CI 1.01–1.16, P = 0.02), respectively. No significant association was seen when winter was compared with summer. Clinical pregnancy rate varied between 36% and 38% and miscarriage rate between 16% and 18%, with no significant seasonal associations.LIMITATIONS, REASONS FOR CAUTIONPossible limitations are the retrospective design of the study and unmeasured confounders. Another limitation is that a generalized estimating equation (GEE) model was not used. The use of a GEE model would have made it possible to include all started fresh IVF/ICSI cycles since it allows for correction for any dependence between cycles within women.WIDER IMPLICATIONS OF THE FINDINGSThe results of this large registry study give no support for the hypothesis that IVF/ICSI treatments performed during summer season, with the highest degree of sunlight and vitamin D synthesis, is associated with higher pregnancy and live birth rates. In fact, our results showed significantly lower live birth rates during summer compared with spring and autumn. However, the magnitude of this difference was small and unlikely of clinical value. We suggest that season should not be taken into consideration when planning and performing fresh IVF/ICSI treatments.STUDY FUNDING/COMPETING INTEREST(S)Financial support was received through the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (ALFGBG-70 940) and grants from the Hjalmar Svensson’s Research Foundation (HJSV2021019 and HJSV2021037). None of the authors declare any conflict of interest.TRIAL REGISTRATION NUMBERN/A.

Prevalence and risk factors for sexual dysfunction in young women following a cancer diagnosis – a population-based study

Background Self-reported sex problems among women diagnosed with reproductive and nonreproductive cancers before the age of 40 are not fully understood. This study aimed to determine sexual dysfunction in young women following a cancer diagnosis in relation to women of the general population. Furthermore, to identify factors associated with sexual dysfunction in women diagnosed with cancer. Materials and Methods A population-based cross-sectional study with 694 young women was conducted 1.5 years after being diagnosed with cancer (response rate 72%). Potential participants were identified in national quality registries covering breast and gynecological cancer, lymphoma and brain tumors. The women with cancer were compared to a group of women drawn from the general population (N = 493). Sexual activity and function were assessed with the PROMIS® SexFS. Logistic regression was used to assess differences between women with cancer and the comparison group, and to identify factors associated with sexual dysfunction. Results The majority of the women with cancer (83%) as well as the women from the comparison group (87%) reported having had sex the last month (partner sex and/or masturbation). More than 60% of the women with cancer (all diagnoses) reported sexual dysfunction in at least one of the measured domains. The women with cancer reported statistically significantly more problems than women of the comparison group across domains such as decreased interest in having sex, and vaginal and vulvar discomfort. Women with gynecological or breast cancer and those receiving more intense treatment were at particular high risk of sexual dysfunction (≥2 domains). Concurrent emotional distress and body image disturbance were associated with more dysfunction. Conclusion The results underscore the need to routinely assess sexual health in clinical care and follow-up. Based on the results, development of interventions to support women to cope with cancer-related sexual dysfunction is recommended.

One-year recovery from breast cancer: Importance of tumor and treatment-related factors, resilience, and sociodemographic factors for health-related quality of life.

AimThis study investigated the changes in health-related quality of life from diagnosis to 1 year after diagnosis in breast cancer (BC) patients and the influence of clinical, psychological, and sociodemographic variables. An additional aim was to explore the mediating and moderating effects of resilience on changes in health-related quality of life.MethodsA longitudinal population-based study was conducted in southern Sweden. Newly diagnosed BC patients filled in measures of health-related quality of life, resilience, and sociodemographic variables at diagnosis (N = 980) and 1 year post-diagnosis (N = 780). Clinical variables were extracted from the Swedish national breast cancer quality registry. Mixed-model analyses were performed.ResultsMost health-related quality of life outcomes declined from diagnosis to 1 year post-diagnosis. Role limitations due to emotional problems remained the same, whereas mental health improved. Lower health-related quality of life outcomes were associated with symptomatic detection and axillary dissection. Patients with a higher TNM stage and histologic grade and estrogen receptor (ER)-negative and human epidermal growth factor 2 (HER2)-positive status, who received chemotherapy, antibody therapy, or bisphosphonate therapy, had a steeper decline in outcomes. Changes in resilience were positively associated with all outcomes but did not mediate or moderate changes in any. Resilience at baseline moderated changes in bodily pain, vitality, and mental health, with higher baseline resilience being associated with a steeper decline, possibly due to floor or ceiling effects. Patients with lower socioeconomic status, educational level, and older age had a lower health-related quality of life.ConclusionPhysical health-related quality of life among breast cancer patients declined 1 year post-diagnosis, whereas mental health-related quality of life improved. Low resilient patients may be especially vulnerable at diagnosis. Biopsychosocial assessment at diagnosis can help identify patients who may require additional support. A multidimensional treatment plan should be started early to help overcome the problems in everyday activities.