| 1. |
- Asif, Sana, M.D, PhD student, et al.
(författare)
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Severe obstetric lacerations associated with postpartum depression among women with low resilience : a Swedish birth cohort study
- 2020
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Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 127:11, s. 1382-1390
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Women's levels of resilience and attitudes towards perineal lacerations vary greatly. Some women see them as part of the birthing process, while others react with anger, depressed mood or even self-harm thoughts. A previous study has reported increased risk of postpartum depressive (PPD) symptoms in women with severe perineal lacerations. The aim of this study was to assess the association between severe obstetric perineal lacerations and PPD. A secondary objective was to assess this association among women with low resilience.DESIGN: Nested cohort study.SETTING: Uppsala, Sweden.SAMPLE: Vaginally delivered women with singleton pregnancies (n = 2,990).METHODS: The main exposure was obstetric perineal lacerations. Resilience was assessed in gestational week 32 using the Swedish version of the Sense of Coherence Scale (SOC-29). A digital acyclic graph (DAG) was used to identify possible confounders and mediators. Logistic regression was used to estimate odds ratios and 95% confidence intervals. A sub-analysis was run after excluding women with normal or high resilience.MAIN OUTCOME MEASURES: Postpartum depression, assessed with the Depression Self-Reporting Scale (DSRS), completed at six weeks postpartum.RESULTS: There was no significant association between severe obstetric perineal lacerations and PPD at six weeks postpartum. However, a significant association was found between severe lacerations and PPD in women with low resilience (OR =4.8 95% CI = 1.2-20), persisting even after adjusting for confounding factors.CONCLUSION: Health care professionals might need to identify women with low resilience, as they are at increased risk for PPD after a severe perineal laceration.
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| 2. |
- Axfors, Cathrine, et al.
(författare)
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Adult attachment's unique contribution in the prediction of postpartum depressive symptoms, beyond personality traits
- 2017
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Ingår i: Journal of Affective Disorders. - : Elsevier BV. - 0165-0327 .- 1573-2517. ; 222, s. 177-184
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Tidskriftsartikel (refereegranskat)abstract
- Background:Personality traits such as neuroticism can help identify pregnant women at risk of postpartum depressive symptoms (PPDS). However, it is unclear whether attachment style could have an additional contribution to this risk elevation. This study aimed to examine the overlap of adult attachment insecurity and neuroticism/trait anxiety as PPDS predictors, taking into account baseline depressive symptoms.Methods:A Swedish population-based sample of pregnant women reported on adult attachment and either neuroticism (n = 1063) or trait anxiety (n = 555). Depressive symptoms were assessed at baseline, and at six weeks and six months postpartum. Correlations between attachment and neuroticism/trait anxiety were calculated. Generalized linear models of PPDS tested the effect of attachment anxiety and avoidance, adjusting for neuroticism/trait anxiety and baseline depression. Logistic regression models with combined high attachment anxiety and-neuroticism/trait anxiety visualized their value as risk factors beyond antenatal depression.Results:Attachment and neuroticism/trait anxiety were highly correlated (r = .55.77). Attachment anxiety exerted a partially independent effect on PPDS at six weeks (p < .05) and at six months (p < .05) adjusting for neuroticism. Among antenatally non-depressed, combined high attachment anxiety and high neuroticism or trait anxiety was predictive of PPDS at both assessment points. Limitations: Low acceptance rate, exclusive use of self-reports.Conclusions:Beyond personality, attachment anxiety had a small independent effect on the risk of PPDS. Combining items of adult attachment and neuroticism/trait anxiety could prove useful in antenatal screening for high risk of PPDS.
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| 3. |
- Axfors, Cathrine
(författare)
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Anxious personality traits in pregnant women : Associations with postpartum depression, delivery complications and health care use
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Anxious personality traits, including those encompassed by negative emotionality (neuroticism) and the tendency to worry about close relationships (attachment anxiety) during pregnancy were the focus of this thesis. The overall aim was to examine perinatal correlates of these characteris-tics in terms of psychiatric and obstetric health as well as antenatal care (ANC).Papers I-II were part of a large population-based project on pregnant women in Uppsala in 2009-2012 (n=2160). Papers III-IV adjoined participants from several projects in 2005-2011, on oral contraceptive use, infertility, induced abortion, premenstrual mood disorder, and perina-tal depression (n=2819). The participants reported on the Swedish universities Scales of Per-sonality for neuroticism (papers II-IV) and the Attachment Style Questionnaire (ASQ) for attachment anxiety (papers I-II). The participants also answered the Edinburgh Postnatal De-pression Scale on depressive symptoms (paper II). In paper III, information on obstetric com-plications for primiparous women with singleton pregnancies (n=1969) was extracted from Swedish national health registers. In paper IV, ANC use was derived from medical records of obstetric low-risk women residing in Uppsala (n=1052).The ASQ had similar psychometric properties in pregnant women (n=1631) as in previous reports (paper I). In non-depressed pregnant women (n=1431), the combination of neuroticism and attachment anxiety was the best risk indicator of postpartum depressive symptoms (paper II). Whereas high neuroticism was not related to obstetric complications (paper III), it was associated with higher use of ANC (paper IV).Summarized, this thesis illustrates how anxious personality traits may predispose for post-partum depression and higher use of ANC in the absence of obstetric complications. Future development of these findings should be to evaluate individual and societal benefits of a greater emphasis on psychological support in ANC.
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| 4. |
- Axfors, Cathrine, et al.
(författare)
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Association between convalescent plasma treatment and mortality in COVID-19 : a collaborative systematic review and meta-analysis of randomized clinical trials
- 2021
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Ingår i: BMC Infectious Diseases. - : BioMed Central (BMC). - 1471-2334. ; 21:1
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Forskningsöversikt (refereegranskat)abstract
- Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, ). Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I-2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
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| 5. |
- Axfors, Cathrine, et al.
(författare)
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Cohort profile : the Biology, Affect, Stress, Imaging and Cognition (BASIC) study on perinatal depression in a population-based Swedish cohort
- 2019
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 9:10
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: With the population-based, prospective Biology, Affect, Stress, Imaging and Cognition (BASIC) cohort, we aim to investigate the biopsychosocial aetiological processes involved in perinatal depression (PND) and to pinpoint its predictors in order to improve early detection.PARTICIPANTS: From September 2009 to November 2018, the BASIC study at Uppsala University Hospital, Sweden, has enrolled 5492 women, in 6478 pregnancies, of which 46.3% first-time pregnancies and with an average age of 31.5 years. After inclusion around gestational week 16-18, participants are followed-up with data collection points around gestational week 32, at childbirth, as well as three times postpartum: after 6 weeks, 6 months and 1 year. At the last follow-up, 70.8% still remain in the cohort.FINDINGS TO DATE: In addition to internet-based surveys with self-report instruments, participants contribute with biological samples, for example, blood samples (maternal and from umbilical cord), biopsies (umbilical cord and placenta) and microbiota samples. A nested case-control subsample also takes part in cognitive and emotional tests, heart rate variability tests and bioimpedance tests. Subprojects have identified various correlates of PND of psychological and obstetric origin in addition to factors of the hypothalamic-pituitary-adrenal axis and immune system.FUTURE PLANS: In parallel with the completion of data collection (final follow-up November 2019), BASIC study data are currently analysed in multiple subprojects. Since 2012, we are conducting an ongoing follow-up study on the participants and their children up to 6 years of age (U-BIRTH). Researchers interested in collaboration may contact Professor Alkistis Skalkidou (corresponding author) with their request to be considered by the BASIC study steering committee.
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| 6. |
- Axfors, Cathrine, et al.
(författare)
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Differential COVID-19 infection rates in children, adults, and elderly : Systematic review and meta-analysis of 38 pre-vaccination national seroprevalence studies
- 2023
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Ingår i: Journal of Global Health. - : International Society of Global Health. - 2047-2978 .- 2047-2986. ; 13
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Forskningsöversikt (refereegranskat)abstract
- BackgroundDebate exists about whether extra protection of elderly and other vulnerable individuals is feasible in COVID-19. We aimed to assess the relative infection rates in the elderly vs the non-elderly and, secondarily, in children vs adults.MethodsWe performed a systematic review and meta-analysis of seroprevalence studies conducted in the pre-vaccination era. We identified representative national studies without high risk of bias through SeroTracker and PubMed searches (last updated May 17, 2022). We noted seroprevalence estimates for children, non-elderly adults, and elderly adults, using cut-offs of 20 and 60 years (or as close to these ages, if they were unavailable) and compared them between different age groups.ResultsWe included 38 national seroprevalence studies from 36 different countries comprising 826 963 participants. Twenty-six of these studies also included pediatric populations and twenty-five were from high-income countries. The median ratio of seroprevalence in elderly vs non-elderly adults (or non-elderly in general, if pediatric and adult population data were not offered separately) was 0.90-0.95 in different analyses, with large variability across studies. In five studies (all in high-income countries), we observed significant protection of the elderly with a ratio of <0.40, with a median of 0.83 in high-income countries and 1.02 elsewhere. The median ratio of seroprevalence in children vs adults was 0.89 and only one study showed a significant ratio of <0.40. The main limitation of our study is the inaccuracies and biases in seroprevalence studies.ConclusionsPrecision shielding of elderly community-dwelling populations before the availability of vaccines was indicated in some high-income countries, but most countries failed to achieve any substantial focused protection.RegistrationOpen Science Framework (available at: https://osf.io/xvupr)
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| 7. |
- Axfors, Cathrine, et al.
(författare)
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Investigating the association between neuroticism and adverse obstetric and neonatal outcomes
- 2019
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- Neuroticism is not only associated with affective disorders but also with certain somatic health problems. However, studies assessing whether neuroticism is associated with adverse obstetric or neonatal outcomes are scarce. This observational study comprises first-time mothers (n = 1969) with singleton pregnancies from several cohorts based in Uppsala, Sweden. To assess neuroticism-related personality, the Swedish universities Scales of Personality was used. Swedish national health registers were used to extract outcomes and confounders. In logistic regression models, odds ratios (ORs) with 95% confidence intervals (Cis) were calculated for the outcomes by an increase of 63 units of neuroticism (equalling the interquartile range). Analyses were adjusted for maternal age, educational level, height, body mass index, year of delivery, smoking during pregnancy, involuntary childlessness, and psychiatric morbidity. Main outcomes were mode of delivery, gestational diabetes mellitus, gestational hypertension, preeclampsia, induction of delivery, prolonged delivery, severe lacerations, placental retention, postpartum haemorrhage, premature birth, infant born small or large for gestational age, and Apgar score. Neuroticism was not independently associated with adverse obstetric or neonatal outcomes besides gestational diabetes. For future studies, models examining sub-components of neuroticism or pregnancy-specific anxiety are encouraged.
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| 8. |
- Axfors, Cathrine, et al.
(författare)
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Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials
- 2021
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Ingår i: Nature Communications. - : Springer Nature. - 2041-1723. ; 12:1
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Tidskriftsartikel (refereegranskat)abstract
- Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I-2=0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I-2=0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities. Hydroxychloroquine and chloroquine have been investigated as a potential treatment for Covid-19 in several clinical trials. Here the authors report a meta-analysis of published and unpublished trials, and show that treatment with hydroxychloroquine for patients with Covid-19 was associated with increased mortality, and there was no benefit from chloroquine.
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| 9. |
- Axfors, Cathrine, et al.
(författare)
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Neuroticism is associated with higher antenatal care utilization in obstetric low-risk women
- 2019
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 98:4, s. 470-478
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionElevated neuroticism is associated with higher health care utilization in the general population. This study aimed to investigate the association between neuroticism and the use of publicly financed antenatal care in obstetric low‐risk women, taking predisposing and need factors for health care utilization into consideration.Material and methodsParticipants comprised 1052 obstetric low‐risk women (no chronic diseases or adverse pregnancy conditions) included in several obstetrics/gynecology studies in Uppsala, Sweden. Neuroticism was self‐rated on the Swedish universities Scales of Personality. Medical records of their first subsequent pregnancy were scanned for antenatal care use. Associations between antenatal care use and neuroticism were analyzed with logistic regression (binary outcomes) or negative binomial regression (count outcomes) comparing the 75th and 25th neuroticism percentiles. Depending on the Akaike information criterion the exposure was modeled as either linear or with restricted cubic splines. Analyses were adjusted for predisposing (sociodemographic and parity) and need factors (body mass index and psychiatric morbidity).ResultsAfter adjustment, women with higher neuroticism had more fetal ultrasounds (incidence rate ratio = 1.09, 95% confidence interval (CI) 1.02‐1.16), more emergency visits to an obstetrician/gynecologist (incidence rate ratio = 1.22, 95% CI 1.03‐1.45) and were more likely to visit a fear‐of‐childbirth clinic (odds ratio = 2.71, 95% CI 1.71‐4.29). Moreover, they more often consulted midwives in specialized antenatal care facilities (significant J‐shaped association).ConclusionsNeuroticism was associated with higher utilization of publicly financed antenatal care in obstetric low‐risk women, even after adjusting for predisposing and need factors. Future studies should address the benefits of interventions as a complement to routine antenatal care programs to reduce subclinical anxiety.
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| 10. |
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| 11. |
- Axfors, Cathrine, et al.
(författare)
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Pre-pregnancy participation and performance in world's largest cross-country ski race as a proxy for physical exercise and fitness, and perinatal outcomes : Prospective registry-based cohort study
- 2023
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Ingår i: British Journal of Obstetrics and Gynecology. - : John Wiley & Sons. - 1470-0328 .- 1471-0528. ; 130:8, s. 891-901
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Investigate associations between pre-pregnancy participation and performance in a demanding cross-country ski race (proxy for exercise volume and fitness) and perinatal outcomes. Pre-registered protocol: osf.io/aywg2.Design: Prospective cohort study.Setting: Based on entire overlap between the Vasaloppet registry and the population-based Swedish Pregnancy Register.Sample: All female Vasaloppet participants 1991-2017 with subsequent singleton delivery (skiers), and age- and county-matched non-skiers.Methods: We calculated odds ratios (ORs) for non-skiers versus skiers (model 1) and, among skiers, by performance (model 2), in Bayesian logistic regressions adjusted for socio-demographics, lifestyle factors, and comorbidities. We repeated calculations adjusting for early pregnancy body mass index (potential mediator) and explored robustness (selection/exposure settings; multiple comparisons correction).Main outcome measures: Twenty-nine important perinatal outcomes, predefined based on existing expert consensus.Results: Non-skiers (n = 194 384) versus skiers (n = 15 377) (and slower versus faster performance, not shown) consistently had higher odds of gestational diabetes mellitus (GDM) (OR 1.70, 95% highest density interval: 1.40-2.09), excessive gestational weight gain (GWG) (1.28, 1.22-1.38), psychiatric morbidity (1.60, 1.49-1.72), any caesarean section (CS) (1.34, 1.28-1.40), elective CS (1.39, 1.29-1.49), and large-for-gestational-age babies (> 90th percentile, 1.11, 1.04-1.18); lower odds of inadequate GWG (0.83, 0.79-0.88); and no associations with fetal/neonatal complications (e.g. preterm birth [1.09, 0.98-1.20], small for gestational age [SGA] [1.23, 1.05-1.45]). Adjustment for body mass index attenuated associations with excessive (1.20, 1.14-1.30) and inadequate GWG (0.87, 0.83-0.92) and large for gestational age (1.07, 1.00-1.13).Conclusion: Non-skiers compared with skiers, and slower versus faster performance, consistently displayed higher odds of GDM, excessive GWG, psychiatric morbidity, CS and large-for-gestational-age babies; and lower odds of inadequate GWG, after adjustment for socio-demographic and lifestyle factors and comorbidities. There were no associations with fetal/neonatal complications.
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| 12. |
- Axfors, Cathrine, et al.
(författare)
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Preferences for Gender Affirming Treatment and Associated Factors Among Transgender People in Sweden
- 2023
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Ingår i: Sexuality Research & Social Policy. - : Springer Nature. - 1868-9884 .- 1553-6610. ; 20:2, s. 479-490
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionGender affirming surgery of primary and/or secondary sex characteristics has been shown to alleviate gender dysphoria. A descriptive snapshot of current treatment preferences is useful to understand the needs of the transgender population seeking health care. This study aimed to describe preferences for gender affirming treatment, and their correlates, among individuals seeking health care for gender dysphoria in Sweden after major national legislative reforms.MethodsCross-sectional study where transgender patients (n = 232) recruited from all six Gender Dysphoria centers in Sweden 2016–2019, answered a survey on treatment preferences and sociodemographic, health, and gender identity-related information during the same time-period. Factors associated with preferring top surgery (breast augmentation or mastectomy), genital surgery, and other surgery (e.g., facial surgery) were examined in univariable and multivariable regression analyses in the 197 people without prior such treatment. Main study outcomes were preferences for feminizing or masculinizing hormonal and surgical gender affirming treatment.ResultsThe proportion among birth assigned male and assigned female patients preferring top surgery was 55.6% and 88.7%, genital surgery 88.9% and 65.7%, and other surgery (e.g., facial surgery) 85.6% and 22.5%, respectively. Almost all participants (99.1%) wanted or had already received hormonal treatment and most (96.7%) wished for some kind of surgical treatment; 55.0% wanted both top and genital surgery. Preferring a binary pronoun (he/she) and factors indicating more severe gender incongruence were associated with a greater wish for surgical treatment. Participants with somatic comorbidities were less likely to want genital surgery, while aF with lacking social support were less likely to want internal genital surgery, in the multivariable analyses.ConclusionsIn this sample of Swedish young adults seeking health care for gender dysphoria, preferences for treatment options varied according to perceived gender identity.Policy ImplicationsThe study fndings underline the need for individualized care and fexible gender afrming treatmentoptions. The role of somatic comorbidities should be further explored, and support should be ofered to transgender peoplein need. There is an unmet need for facial surgery among aM
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| 13. |
- Axfors, Cathrine, et al.
(författare)
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Psychometric properties of the attachment style questionnaire in Swedish pregnant women : short and full versions
- 2017
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Ingår i: Journal of Reproductive and Infant Psychology. - : Routledge. - 0264-6838 .- 1469-672X. ; 35:5, s. 450-461
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: (i) To evaluate the reliability and factor structure of the Attachment Style Questionnaire – Short Form (ASQ-SF) for use in pregnant women and (ii) to compare the reliability and factor structure of the short- and full version-ASQ among pregnant women. Background: Adult attachment insecurity is currently included as a major risk factor in studies of perinatal health. None of the self-report measures with a Swedish translation have been psychometrically evaluated in a pregnant cohort.Methods: A population-based cohort of 1631 pregnant women answered the ASQ in late pregnancy. Internal consistency (item- subscale correlations, Cronbach’s α, and α if item deleted) was evaluated for the seven available subscales. Con rmatory factor analysis (CFA) was run to examine the factor structure of the short form compared with the full-version. Test–retest correlations were assessed in a subgroup (n = 48).Results: All mean item-subscale correlations for the ASQ-SF were > 0.30. Cronbach’s α’s for ASQ-SF dimensions were as follows: Avoidance (0.87); Anxiety (0.89); Discomfort with Closeness (0.85); Relationships as Secondary (0.54); Con dence (0.83); Need for Approval (0.76); and Preoccupation with Relationships (0.77). No item removal substantively increased subscale α’s. The CFA demonstrated better model t for the ASQ-SF than for the full-version ASQ, while other reliability measures were similar. Test–retest correlations ranged from 0.65 to 0.84.Conclusion: The ASQ-SF showed similar psychometric properties in pregnant women as in the general population and had good reliability, but the optimal factor structure needs to be studied further. Results support the usage of the ASQ-SF in pregnant cohorts.
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| 14. |
- Axfors, Cathrine, et al.
(författare)
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Published registry-based pharmacoepidemiologic associations show limited concordance with agnostic medication-wide analyses
- 2023
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 0895-4356 .- 1878-5921. ; 160, s. 33-45
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To assess how the results of published national registry-based pharmacoepidemiology studies (where select associations are of interest) compare with an agnostic medication-wide approach (where all possible drug associations are tested).Study Design and Setting: We systematically searched for publications that reported drug associations with any, breast, colon/colorectal, or prostate cancer in the Swedish Prescribed Drug Registry. Results were compared against a previously performed agnostic medication-wide study on the same registry. Protocol: https://osf.io/kqj8n.Results: Most published studies (25/32) investigated previously reported associations. 421/913 (46%) associations had statistically significant results. 134 of the 162 unique drug-cancer associations could be paired with 70 associations in the agnostic study (corresponding drug categories and cancer types). Published studies reported smaller effect sizes and absolute effect sizes than the agnostic study, and generally used more adjustments. Agnostic analyses were less likely to report statistically significant protective associations (based on a multiplicity-corrected threshold) than their paired associations in published studies (McNemar odds ratio 0.13, P = 0.0022). Among 162 published associations, 36 (22%) showed increased risk signal and 25 (15%) protective signal at P < 0.05, while for agnostic associations, 237 (11%) showed increased risk signal and 108 (5%) protective signal at a multiplicity-corrected threshold. Associations belonging to drug categories targeted by individual published studies vs. nontargeted had smaller average effect sizes; smaller P values; and more frequent risk signals.Conclusion: Published pharmacoepidemiology studies using a national registry addressed mostly previously proposed associations, were mostly “negative”, and showed only modest concordance with their respective agnostic analyses in the same registry.
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| 15. |
- Belbasis, Lazaros, et al.
(författare)
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Mapping and systematic appraisal of umbrella reviews in epidemiological research : a protocol for a meta-epidemiological study
- 2023
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Ingår i: Systematic Reviews. - : BioMed Central (BMC). - 2046-4053. ; 12
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Umbrella review is one of the terms used to describe an overview of systematic reviews. During the last years, a rapid increase in the number of umbrella reviews on epidemiological studies has been observed, but there is no systematic assessment of their methodological and reporting characteristics. Our study aims to fill this gap by performing a systematic mapping of umbrella reviews in epidemiological research.Methods: We will perform a meta-epidemiological study including a systematic review in MEDLINE and EMBASE to identify all the umbrella reviews that focused on systematic reviews of epidemiological studies and were published from inception until December 31, 2022. We will consider eligible any research article which was designed as an umbrella review and summarized systematic reviews and meta-analyses of epidemiological studies. From each eligible article, we will extract information about the research topic, the methodological characteristics, and the reporting characteristics. We will examine whether the umbrella reviews assessed the strength of the available evidence and the rigor of the included systematic reviews. We will also examine whether these characteristics change across time.Discussion: Our study will systematically appraise the methodological and reporting characteristics of published umbrella reviews in epidemiological literature. The findings of our study can be used to improve the design and conduct of future umbrella reviews, to derive a standardized set of reporting and methodological guidelines for umbrella reviews, and to allow further meta-epidemiological work.
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| 16. |
- Bilal, Ayesha, et al.
(författare)
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Predicting perinatal health outcomes using smartphone-based digital phenotyping and machine learning in a prospective Swedish cohort (Mom2B) : study protocol
- 2022
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 12:4
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Perinatal complications, such as perinatal depression and preterm birth, are major causes of morbidity and mortality for the mother and the child. Prediction of high risk can allow for early delivery of existing interventions for prevention. This ongoing study aims to use digital phenotyping data from the Mom2B smartphone application to develop models to predict women at high risk for mental and somatic complications.Methods and analysis: All Swedish-speaking women over 18 years, who are either pregnant or within 3 months postpartum are eligible to participate by downloading the Mom2B smartphone app. We aim to recruit at least 5000 participants with completed outcome measures. Throughout the pregnancy and within the first year postpartum, both active and passive data are collected via the app in an effort to establish a participant's digital phenotype. Active data collection consists of surveys related to participant background information, mental and physical health, lifestyle, and social circumstances, as well as voice recordings. Participants' general smartphone activity, geographical movement patterns, social media activity and cognitive patterns can be estimated through passive data collection from smartphone sensors and activity logs. The outcomes will be measured using surveys, such as the Edinburgh Postnatal Depression Scale, and through linkage to national registers, from where information on registered clinical diagnoses and received care, including prescribed medication, can be obtained. Advanced machine learning and deep learning techniques will be applied to these multimodal data in order to develop accurate algorithms for the prediction of perinatal depression and preterm birth. In this way, earlier intervention may be possible.Ethics and dissemination: Ethical approval has been obtained from the Swedish Ethical Review Authority (dnr: 2019/01170, with amendments), and the project fully fulfils the General Data Protection Regulation (GDPR) requirements. All participants provide consent to participate and can withdraw their participation at any time. Results from this project will be disseminated in international peer-reviewed journals and presented in relevant conferences.
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| 17. |
- Gloy, Viktoria, et al.
(författare)
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The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020
- 2023
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Ingår i: International Journal of Cancer. - : John Wiley & Sons. - 0020-7136 .- 1097-0215. ; 152:12, s. 2474-2484
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Tidskriftsartikel (refereegranskat)abstract
- Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.
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| 18. |
- Iliadis, Stavros I., 1983-, et al.
(författare)
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Psychometric properties and concurrent validity of the Transgender Congruence Scale (TCS) in the Swedish setting
- 2020
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Ingår i: Scientific Reports. - : Nature Publishing Group. - 2045-2322. ; 10:1
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Tidskriftsartikel (refereegranskat)abstract
- The Transgender Congruence Scale (TCS) is a non-binary tool used in Sweden for gender dysphoria (GD) assessment; however, its Swedish version has not been validated. To investigate the psychometric properties of the TCS, its capacity to distinguish individuals with GD and its concurrent validity compared to other scales. Patients with GD (n=135) and controls (n=443) filled in a questionnaire containing sociodemographic questions, the TCS, the Utrecht Gender Dysphoria Scale (UGDS), and the Gender Identity/Gender Dysphoria Questionnaire for Adolescents and Adults (GIDYQ-AA). TCS had good discriminatory validity and internal consistency. Patients with GD, stratified by birth-assigned sex, had lower TCS scores compared to controls. Confirmatory factor analysis (CFA) supported the two-factor model of the TCS. Multiple-group CFA suggested measurement invariance between birth-assigned sexes and configural invariance between patients with GD and controls. Area under the ROC curve for birth-assigned males was 0.991 and for females 0.994. A TCS mean value of three provided sensitivity 94.3% and 95.1% as well as specificity 98.6% and 98% for aM and aF, respectively. The TCS was significantly correlated to UGDS and GIDYQ-AA. The TCS may be a valuable tool in the clinical assessment of individuals with GD.
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| 19. |
- Iliadis, Stavros I, 1983-, et al.
(författare)
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Self-Harm Thoughts Postpartum as a Marker for Long-Term Morbidity
- 2018
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Ingår i: Frontiers In Public Health. - : Frontiers Media SA. - 2296-2565. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Postpartum depression predisposes to maternal affective and somatic disorders. It is important to identify which women are at an increased risk of subsequent morbidity and would benefit from an intensified follow-up. Self-harm thoughts (SHTs), with or without other depressive symptomatology, might have prognostic value for maternal health beyond the postpartum period.Aim: This study is to investigate the somatic and psychiatric morbidity of postpartum women with SHTs, with or without other depressive symptoms, over a 7-year follow-up period.Materials and methods: The subjects for this study are derived from a population based Swedish cohort of women who gave birth at Uppsala University Hospital (May 2006-June 2007) and who answered the Edinburgh Postnatal Depression Scale (EPDS) at 5 days, 6 weeks, and 6 months postpartum. Three groups were included: women reporting SHTs (SHT group, n = 107) on item 10 of the EPDS; women reporting depressive symptoms, i.e., EPDS >= 12 at 6 weeks and/or 6 months postpartum, without SHTs (DEP group, n = 94); and randomly selected controls screening negatively for postpartum depression (CTL group, n = 104). The number of diagnostic codes for somatic and psychiatric morbidity according to the International Statistical Classification of Diseases and Related Health Problems system, and the number of medical interventions were retrieved from medical records over 7 years following childbirth and were used as the outcome measures, together with any prescription of antidepressants and sick leave during the follow-up.Results: The SHT group had the highest psychiatric morbidity of all groups and more somatic morbidity than controls. Affective disorders were more common in the SHT and the DEP groups compared with controls, as well as antidepressant prescriptions and sick leave. One-fifth of women with SHTs did not screen positive for depressive symptoms; nevertheless, they had more somatic and psychiatric morbidity than the control group.Conclusion: Women reporting thoughts of self-harm in the postpartum period are at an increased risk of somatic and psychiatric morbidity during a follow-up of 7 years after delivery, and this increased risk may not be fully attributed to depressive symptoms. Results underline the importance of screening for self-harm symptoms postpartum and point to a need for individualized follow-up.
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| 20. |
- Iliadis, Stavros I, 1983-, et al.
(författare)
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Women with prolonged nausea in pregnancy have increased risk for depressive symptoms postpartum
- 2018
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Ingår i: Scientific Reports. - : Nature Publishing Group. - 2045-2322. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this population-based, longitudinal study was to assess the association between nausea and vomiting in pregnancy (NVP) and perinatal depressive symptoms. Pregnant women (N = 4239) undergoing routine ultrasound at gestational week (GW) 17 self-reported on NVP and were divided into those without nausea (G0), early (<= 17 GW) nausea without medication (G1), early nausea with medication (G2), and prolonged (>17 GW) nausea (G3). The Edinburgh Postnatal Depression Scale at GW 17 and 32 (cut-off >= 13) and at six weeks postpartum (cut-off >= 12) was used to assess depressive symptoms. Main outcome measures were depressive symptoms at GW 32 and at six weeks postpartum. NVP was experienced by 80.7%. The unadjusted logistic regression showed a positive association between all three nausea groups and depressive symptoms at all time-points. After adjustment, significant associations with postpartum depressive symptoms remained for G3, compared to G0 (aOR = 1.66; 95% CI 1.1-2.52). After excluding women with history of depression, only the G3 group was at higher odds for postpartum depressive symptoms (aOR = 2.26; 95% CI 1.04-4.92). In conclusion, women with prolonged nausea have increased risk of depressive symptoms at six weeks postpartum, regardless of history of depression.
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| 21. |
- Ioannidis, John P. A., et al.
(författare)
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Population-level COVID-19 mortality risk for non-elderly individuals overall and for non-elderly individuals without underlying diseases in pandemic epicenters
- 2020
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Ingår i: Environmental Research. - : Elsevier BV. - 0013-9351 .- 1096-0953. ; 188
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To provide estimates of the relative rate of COVID-19 death in people <65 years old versus older individuals in the general population, the absolute risk of COVID-19 death at the population level during the first epidemic wave, and the proportion of COVID-19 deaths in non-elderly people without underlying diseases in epicenters of the pandemic. Eligible data: Cross-sectional survey of countries and US states with at least 800 COVID-19 deaths as of April 24, 2020 and with information on the number of deaths in people with age <65. Data were available for 14 countries (Belgium, Canada, France, Germany, India, Ireland, Italy, Mexico, Netherlands, Portugal, Spain, Sweden, Switzerland, UK) and 13 US states (California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, New Jersey, New York, Pennsylvania). We also examined available data on COVID-19 deaths in people with age <65 and no underlying diseases. Main outcome measures: Proportion of COVID-19 deaths in people <65 years old; relative mortality rate of COVID-19 death in people <65 versus >= 65 years old; absolute risk of COVID-19 death in people <65 and in those >= 80 years old in the general population as of June 17, 2020; absolute COVID-19 mortality rate expressed as equivalent of mortality rate from driving a motor vehicle. Results: Individuals with age <65 account for 4.5-11.2% of all COVID-19 deaths in European countries and Canada, 8.3-22.7% in the US locations, and were the majority in India and Mexico. People <65 years old had 30to 100-fold lower risk of COVID-19 death than those >= 65 years old in 11 European countries and Canada, 16- to 52-fold lower risk in US locations, and less than 10-fold in India and Mexico. The absolute risk of COVID-19 death as of June 17, 2020 for people <65 years old in high-income countries ranged from 10 (Germany) to 349 per million (New Jersey) and it was 5 per million in India and 96 per million in Mexico. The absolute risk of COVID19 death for people >= 80 years old ranged from 0.6 (Florida) to 17.5 per thousand (Connecticut). The COVID-19 mortality rate in people <65 years old during the period of fatalities from the epidemic was equivalent to the mortality rate from driving between 4 and 82 miles per day for 13 countries and 5 states, and was higher (equivalent to the mortality rate from driving 106-483 miles per day) for 8 other states and the UK. People <65 years old without underlying predisposing conditions accounted for only 0.7-3.6% of all COVID-19 deaths in France, Italy, Netherlands, Sweden, Georgia, and New York City and 17.7% in Mexico. Conclusions: People <65 years old have very small risks of COVID-19 death even in pandemic epicenters and deaths for people <65 years without underlying predisposing conditions are remarkably uncommon. Strategies focusing specifically on protecting high-risk elderly individuals should be considered in managing the pandemic.
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| 22. |
- Ioannidis, John P. A., et al.
(författare)
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Second versus first wave of COVID-19 deaths : Shifts in age distribution and in nursing home fatalities
- 2021
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Ingår i: Environmental Research. - : Elsevier. - 0013-9351 .- 1096-0953. ; 195
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To examine whether the age distribution of COVID-19 deaths and the share of deaths in nursing homes changed in the second versus the first pandemic wave. Eligible data: We considered all countries that had at least 4000 COVID-19 deaths occurring as of January 14, 2021, at least 200 COVID-19 deaths occurring in each of the two epidemic wave periods; and which had sufficiently detailed information available on the age distribution of these deaths. We also considered countries with data available on COVID-19 deaths of nursing home residents for the two waves. Main outcome measures: Change in the second wave versus the first wave in the proportion of COVID-19 deaths occurring in people <50 years ("young deaths") among all COVID-19 deaths and among COVID-19 deaths in people <70 years old; and change in the proportion of COVID-19 deaths in nursing home residents among all COVID-19 deaths. Results: Data on age distribution were available for 14 eligible countries. Individuals <50 years old had small absolute difference in their share of the total COVID-19 deaths in the two waves across 13 high-income countries (absolute differences 0.0-0.4%). Their proportion was higher in Ukraine, but it decreased markedly in the second wave. The proportion of young deaths was lower in the second versus the first wave (summary prevalence ratio 0.81, 95% CI 0.71-0.92) with large between-country heterogeneity. The proportion of young deaths among deaths <70 years did not differ significantly across the two waves (summary prevalence ratio 0.96, 95% CI 0.86-1.06). Eligible data on nursing home COVID-19 deaths were available for 11 countries. The share of COVID-19 deaths that were accounted by nursing home residents decreased in the second wave significantly and substantially in 8 countries (prevalence ratio estimates: 0.36 to 0.78), remained the same in Denmark and Norway and markedly increased in Australia. Conclusions: In the examined countries, age distribution of COVID-19 deaths has been fairly similar in the second versus the first wave, but the contribution of COVID-19 deaths in nursing home residents to total fatalities has decreased in most countries in the second wave.
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| 23. |
- Janiaud, Perrine, et al.
(författare)
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Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients With COVID-19 : A Systematic Review and Meta-analysis
- 2021
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Ingår i: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 325:12, s. 1185-1195
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Forskningsöversikt (refereegranskat)abstract
- IMPORTANCE Convalescent plasma is a proposed treatment for COVID-19. OBJECTIVE To assess clinical outcomes with convalescent plasma treatment vs placebo or standard of care in peer-reviewed and preprint publications or press releases of randomized clinical trials (RCTs). DATA SOURCES PubMed, the Cochrane COVID-19 trial registry, and the Living Overview of Evidence platform were searched until January 29, 2021. STUDY SELECTION The RCTs selected compared any type of convalescent plasma vs placebo or standard of care for patients with confirmed or suspected COVID-19 in any treatment setting. DATA EXTRACTION AND SYNTHESIS Two reviewers independently extracted data on relevant clinical outcomes, trial characteristics, and patient characteristics and used the Cochrane Risk of Bias Assessment Tool. The primary analysis included peer-reviewed publications of RCTs only, whereas the secondary analysis included all publicly available RCT data (peer-reviewed publications, preprints, and press releases). Inverse variance-weighted meta-analyses were conducted to summarize the treatment effects. The certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation. MAIN OUTCOMES AND MEASURES All-cause mortality, length of hospital stay, clinical improvement, clinical deterioration, mechanical ventilation use, and serious adverse events. RESULTS A total of 1060 patients from 4 peer-reviewed RCTs and 10 722 patients from 6 other publicly available RCTs were included. The summary risk ratio (RR) for all-cause mortality with convalescent plasma in the 4 peer-reviewed RCTs was 0.93 (95% CI, 0.63 to 1.38), the absolute risk difference was -1.21% (95% CI, -5.29% to 2.88%), and there was low certainty of the evidence due to imprecision. Across all 10 RCTs, the summary RR was 1.02 (95% CI, 0.92 to 1.12) and there was moderate certainty of the evidence due to inclusion of unpublished data. Among the peer-reviewed RCTs, the summary hazard ratio was 1.17 (95% CI, 0.07 to 20.34) for length of hospital stay, the summary RR was 0.76 (95% CI, 0.20 to 2.87) for mechanical ventilation use (the absolute risk difference for mechanical ventilation use was -2.56%[95% CI, -13.16% to 8.05%]), and there was low certainty of the evidence due to imprecision for both outcomes. Limited data on clinical improvement, clinical deterioration, and serious adverse events showed no significant differences. CONCLUSIONS AND RELEVANCE Treatment with convalescent plasma compared with placebo or standard of care was not significantly associated with a decrease in all-cause mortality or with any benefit for other clinical outcomes. The certainty of the evidence was low to moderate for all-cause mortality and low for other outcomes.
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| 24. |
- Lager, Susanne, et al.
(författare)
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Alcohol consumption habits and associations with anxiety or depressive symptoms postpartum in women with high socioeconomic status in Sweden.
- 2022
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Ingår i: Archives of Women's Mental Health. - : Springer Nature. - 1434-1816 .- 1435-1102.
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Tidskriftsartikel (refereegranskat)abstract
- Postpar tum depression and anxiety are common among new mothers. It is well-established that in the general population alcohol use is associated with depression and anxiety. Linking alcohol consumption to symptoms of postpartum depression (PPDS) or postpartum anxiety (PPAS) is presently less established. This study aims to determine if alcohol consumption pre-pregnancy, 6 weeks postpartum, 6 months postpartum, or changes in alcohol consumption are associated with PPDS or PPAS. Longitudinal data on 3849 women from a Swedish perinatal cohort were analyzed using logistic regression analyses for associations between alcohol consumption and symptoms of anxiety or depression, as assessed with the Edinburgh Postnatal Depression Scale. There was no association between pre-pregnancy drinking habits and PPDS (p = 0.588, n = 2479) or PPAS (p = 0.942; n = 2449) at 6 weeks postpartum. Similarly, no associations were observed between concurrent drinking habits at 6 weeks postpartum and PPAS (p = 0.070, n = 3626), 6 months postpartum and PPDS (0.647, n = 3461) or PPAS (p = 0.700, n = 3431). However, there was an association between drinking habits at 6 weeks postpartum and concurrent PPDS (p = 0.047, n = 3659). In conclusion, robust associations were not found between postpartum alcohol consumption and mood symptoms. This lack of association between poor mental health and risk behaviors in new mothers could be interpreted as a result of long-term policy work and high participation in Swedish maternity care. Future studies need to address these research questions in more diverse socio-cultural contexts.
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| 25. |
- Naudet, Florian, et al.
(författare)
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Medical journal requirements for clinical trial data sharing : Ripe for improvement
- 2021
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Ingår i: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 18:10
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Tidskriftsartikel (refereegranskat)abstract
- Summary points:Efficient sharing and reuse of data from clinical trials are critical in advancing medical knowledge and developing improved treatments.We believe that the International Committee of Medical Journal Editors (ICMJE) clinical trial data sharing policy is currently inadequate.Although data sharing plans help increase transparency, they do not ensure that data are shared, and they are often inadequately implemented.We believe that the ICMJE should adapt a stronger policy on data sharing that is enforced rigorously in all ICMJE members and affiliated journals.The policy should include a strong evaluation component to ensure that all clinical trial data are shared, their value maximized, and data producers incentivized.
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