The impact of comorbid diseases on ovarian cancer survival is largely unknown. We therefore examined (i) the prevalence of comorbidity among ovarian cancer patients and (ii) the impact of comorbidity ...on ovarian cancer survival and mortality. Using hospital discharge data, we identified Danish women diagnosed with ovarian cancer between 1995 and 2005 (n= 1995 within a population of 1.6 million) and then computed Charlson comorbidity index scores (0, 1-2, and 3+). We estimated the prevalence of comorbidity and computed absolute survival and relative mortality rate ratios (MRRs) according to comorbidity level, using patients with Charlson score 0 as the reference group. During the study period, the proportion of patients without comorbidity fell from 81% to 75%, while the proportion of patients with comorbidity score 1-2 and 3+ rose from 16% to 21% and from 4% to 5%, respectively. Overall 1-year survival increased from 68% in 1995-1997 to 70% in 1998-2000 and to 73% in 2001-2004. For patients with Charlson score 1-2, 1-year adjusted MRRs were 1.1 (95% CI, 0.8-1.6) in 1995-1997, 1.3 (95% CI, 1.0-1.8) in 1998-2000, and 1.7 (95% CI, 1.3-2.4) in 2001-2004. For patients with Charlson score 3+, 1-year adjusted MRRs were 2.4 (95% CI, 1.4-4.3) in 1995-1997, 1.6 (95% CI, 1.0-2.7) in 1998-2000, and 2.2 (95% CI, 1.3-3.8) in 2001-2004. The 5-year MRRs were similar to the 1-year MRRs. One quarter of Danish women with ovarian cancer were found to have comorbid conditions, and 5% had severe comorbidity. Severe comorbidity was a predictor of poorer survival.
Population-based health care databases are a valuable tool for observational studies as they reflect daily medical practice for large and representative populations. A constant challenge in ...observational designs is, however, to rule out confounding, and the value of these databases for a given study question accordingly depends on completeness and validity of the information on confounding factors. In this article, we describe the types of potential confounding factors typically lacking in large health care databases and suggest strategies for confounding control when data on important confounders are unavailable. Using Danish health care databases as examples, we present the use of proxy measures for important confounders and the use of external adjustment. We also briefly discuss the potential value of active comparators, high-dimensional propensity scores, self-controlled designs, pseudorandomization, and the use of positive or negative controls.
Aim
The objective of primary radiotherapy for anal cancer is to remove cancer while maintaining anorectal function. However, little is known about anorectal function among long‐term survivors without ...colostomy. Using a cross‐sectional questionnaire study, we examined symptoms and distress related to the dysfunction of pelvic organs after radiotherapy for anal cancer.
Method
A questionnaire regarding anorectal, urinary and sexual symptoms was sent to anal cancer patients without recurrence or colostomy, diagnosed during 1996–2003, and treated with curative intent (chemo)radiotherapy at three Danish centres. For each symptom we assessed frequency and severity and the level of symptom‐induced distress (no, little, moderate or great distress).
Results
Of 94 eligible patients, 84 (89%) returned the completed questionnaire at a median of 33 months after radiotherapy. Incontinence for solid stools, liquid stools and gas occurred at least monthly in 31%, 54% and 79% of patients, respectively. Overall 40% of patients reported great distress from incontinence for solid or liquid stools at least monthly. Faecal urgency occurring at least monthly was experienced by 87% of patients and caused great distress in 43%. Stress, urge or another type of urinary incontinence occurred at least monthly in 45% and caused great distress in 21%. Urinary urgency occurred at least monthly in 48% but only caused great distress in 14%. Sexual desire was severely decreased in 58% and only 24% were satisfied with their sexual function.
Conclusion
Distressing long‐term anorectal and sexual dysfunction was common after radiotherapy for anal cancer, and morbidity due to urinary dysfunction was moderate.
Objective To assess whether maternal use of selective serotonin reuptake inhibitors (SSRIs) increases the risk of persistent pulmonary hypertension in the newborn, and whether such an effect might ...differ between specific SSRIs.Design Population based cohort study using data from the national health registers.Setting Denmark, Finland, Iceland, Norway, and Sweden, 1996-2007.Participants More than 1.6 million infants born after gestational week 33.Main outcome measures Risks of persistent pulmonary hypertension of the newborn associated with early and late exposure to SSRIs during pregnancy and adjusted for important maternal and pregnancy characteristics. Comparisons were made between infants exposed and not exposed to SSRIs.Results Around 30 000 women had used SSRIs during pregnancy and 11 014 had been dispensed an SSRI later than gestational week 20. Exposure to SSRIs in late pregnancy was associated with an increased risk of persistent pulmonary hypertension in the newborn: 33 of 11 014 exposed infants (absolute risk 3 per 1000 liveborn infants compared with the background incidence of 1.2 per 1000); adjusted odds ratio 2.1 (95% confidence interval 1.5 to 3.0). The increased risks of persistent pulmonary hypertension in the newborn for each of the specific SSRIs (sertraline, citalopram, paroxetine, and fluoxetine) were of similar magnitude. Filling a prescription with SSRIs before gestational week 8 yielded slightly increased risks: adjusted odds ratio 1.4 (95% confidence interval 1.0 to 2.0).Conclusions The risk of persistent pulmonary hypertension of the newborn is low, but use of SSRIs in late pregnancy increases that risk more than twofold. The increased risk seems to be a class effect.
Urinary tract infections have been linked with urinary tract cancer, but the association remains controversial. We examined whether pyelonephritis is a clinical marker of urogenital cancer.
We used ...Danish medical databases to create a population-based cohort of patients with an incident hospital-based pyelonephritis diagnosis during 1994–2013. Follow-up for cancer began at pyelonephritis diagnosis and ended on 30 November 2013. We restricted the cohort to patients older than 50 years, as urogenital cancer risk in the younger population is low. We calculated the absolute risk of urogenital cancer and the standardized incidence ratio (SIR) comparing risk observed in pyelonephritis patients to risk expected in the general population of Denmark.
Among 15 070 patients with pyelonephritis, we observed 197 urinary tract cancers and 374 genital organ cancers over a 20-year follow-up period. The absolute risk of urogenital cancer was 1.5% 6 months after a pyelonephritis diagnosis, and the cumulative risk was 3.0% at 5 years. During the first 6 months following a pyelonephritis diagnosis, the SIR of urogenital cancer was 8.56 (95% CI 7.49–9.75). Between 6 and 12 months following this diagnosis, the SIR was 1.75 (95% CI 1.26–2.35), and beyond 1 year the SIR was approximately unity for most cancers. Notably, the SIR for bladder cancer among women remained elevated beyond 1 year of follow-up.
Patients presenting with a hospital-based diagnosis of pyelonephritis had a higher 6-month risk of urogenital cancer than expected. However, causation cannot be inferred because of the study design.
In a Danish nationwide cohort study of 292 births from 1973 to 2002 in women with Hodgkin's disease (HD), we compared birth outcome with 14 042 births from a cohort of mothers without cancer. We ...found no substantially increased risk of preterm birth, low birth weight at term, or stillbirth and no difference in proportion of male newborns for 192 children of women with HD before pregnancy. The prevalence odds ratio (POR) for congenital abnormalities was 1.7 (95% confidence interval (CI): 0.9-3.1). Among 15 newborns of mothers diagnosed during pregnancy, the POR of preterm birth was 26.6 (95% CI: 8.5-83.0), but five out of the eight preterm deliveries among these women were elective. We found no substantially increased risk of adverse birth outcome among 85 newborns of women diagnosed within 2 years postpartum, though effect estimates were imprecise. The overall findings are reassuring, they cannot exclude the possibility of an increased risk of congenital abnormalities for newborns of women diagnosed with HD before pregnancy.
The original version of the Childhood Health Assessment Questionnaire (CHAQ30orig) suffers from a ceiling effect and hence has reduced clinical validity. The purpose of this study was to evaluate the ...effect of adding eight more demanding items (CHAQ38) and a new categorical response option (CATII) on discriminant validity and score distribution in a European patient sample.
Eighty-nine children with Juvenile Idiopathic arthritis (JIA) and 22 healthy controls, aged 7-16 years, were recruited from eight centres across Europe. Eight new CHAQ items and scoring option were translated back and forth for the countries in which they were not already present. Demographic, clinical, and CHAQ data were collected on-site. Subsequently, five different scoring methods were applied, i.e. the original method (CHAQ30orig) and four alternatives. These alternatives consisted of the mean item scores for the 30 and 38-question versions with either the original (CATI), or the new categorical response option (CATII). The five versions were tested for their ability to distinguish between patients and controls. Furthermore score distributions were evaluated and visualized by box and whisker plots.
Two CHAQ revisions with the new response option showed poor discriminative ability, whereas one revised version (CHAQ38CATI) had comparable discriminative ability comparable to the original CHAQ. A profound ceiling effect was observed in the original scoring method of the CHAQ (27%). The addition of eight more demanding items and application of a plain mean item score reduced this significantly to 14% (chi2 = 4.21; p < 0.05).
Revising the CHAQ by adding eight more demanding items and applying a plain mean item scoring (CHAQ38CATI) maintained discriminant ability and reduced the ceiling effect in a European patient sample. The new categorical response option (CATII) seemed promising, but was less able to distinguish children with JIA from healthy controls and had less favourable distribution characteristics. The CHAQ38CATI is advocated for future use in mildly affected JIA patients.
Salvage surgery of recurrent or persistent anal cancer following radiotherapy is often followed by perineal wound complications. We examined survival and perineal wound complications in anal cancer ...salvage surgery during a 10-year period with primary perineal reconstruction predominantly performed using vertical rectus abdominis myocutaneous (VRAM) flap. Between 1997 and 2006, 49 patients underwent anal cancer salvage surgery. Of these, 48 had primary reconstruction with VRAM. Overall survival was computed by the Kaplan–Meier method and mortality rate ratios (MRRs) by Cox regression. One patient (2%) died within 30 days postoperatively. Postoperative complications necessitated reoperation in eight (16%) patients. We found no major perineal wound infections. Major perineal wound breakdown occurred in the only patient in whom VRAM was not used. Five-year survival was 61% 95% confidence interval (CI) 43–75%. Free resection margins (R0) were obtained in 78% of patients, with 5-year survival of 75% (95% CI 53–87%). Involved margins, microscopically only (R1) or macroscopically (R2), strongly predicted an adverse outcome age-adjusted 2-year MRRs (95% CI) R1 vs. R0 = 4.1 (0.7–23.6), R2 vs. R0 = 10.9 (2.2–54.2). We conclude that anal cancer salvage surgery can yield long-time survival but obtaining free margins is critical. A low rate of perineal complications is achievable by primary perineal reconstruction using VRAM flap.
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