PALLiative care in ONcology (PALLiON): A cluster-randomised trial investigating the effect of palliative care on the use of anticancer treatment at the end of life.

BACKGROUND: Effects on anticancer therapy following the integration of palliative care and oncology are rarely investigated. Thus, its potential effect is unknown. AIM: To investigate the effects of the complex intervention PALLiON versus usual care on end-of-life anticancer therapy. DESIGN: Cluster-randomised controlled trial (RCT), registered at ClinicalTrials.gov (No. NCT01362816). The complex intervention consisted of a physician education program enhancing theoretical, clinical and communication skills, a patient-centred care pathway and patient symptom reporting prior to all consultations. Primary outcome was overall use, start and cessation of anticancer therapy in the last 3 months before death. Secondary outcomes were patient-reported outcomes. Mixed effects logistic regression models and Cox proportional hazard were used. SETTING: A total of 12 Norwegian hospitals (03/2017-02/2021). PARTICIPANTS: Patients ⩾18 years, advanced stage solid tumour, starting last line of anticancer therapy, estimated life expectancy ⩽12 months. RESULTS: A total of 616 (93%) patients were included (intervention: 309/control:307); 63% males, median age 69, 77% had gastrointestinal cancers. Median survival time from inclusion was 8 (IQR 3-14) and 7 months (IQR 3-12), and days between anticancer therapy start and death were 204 (90-378) and 168 (69-351) (intervention/control). Overall, 78 patients (13%) received anticancer therapy in the last month (intervention: 33 [11%]/control: 45 [15%]). No differences were found in patient-reported outcomes. CONCLUSION: We found no significant differences in the probability of receiving end-of-life anticancer therapy. The intervention did not have the desired effect. It was probably too general and too focussed on communication skills to exert a substantial influence on conventional clinical practice.

Lipid levels after childbirth and association with number of children: A population-based cohort study.

OBJECTIVE: Low parity women are at increased risk of cardiovascular mortality. Unfavourable lipid profiles have been found in one-child mothers years before they conceive. However, it remains unclear whether unfavourable lipid profiles are evident in these women also after their first birth. The aim was to estimate post-pregnancy lipid levels in one-child mothers compared to mothers with two or more children and to assess these lipid's associations with number of children. METHODS: We used data on 32 618 parous women (4 490 one-child mothers and 28 128 women with ≥2 children) examined after first childbirth as part of Cohort of Norway (1994-2003) with linked data on reproduction and number of children from the Medical Birth Registry of Norway (1967-2008). Odds ratios (ORs) with 95% confidence intervals (CIs) for one lifetime pregnancy (vs. ≥2 pregnancies) by lipid quintiles were obtained by logistic regression and adjusted for age at examination, year of first birth, body mass index, oral contraceptive use, smoking and educational level. RESULTS: Compared to women with the lowest quintiles, ORs for one lifetime pregnancy for the highest quintiles of LDL and total cholesterol were 1.30 (95%CI: 1.14-1.45) and 1.43 (95%CI: 1.27-1.61), respectively. Sensitivity analysis (women <40 years) showed no appreciable change in our results. In stratified analyses, estimates were slightly stronger in overweight/obese, physically inactive and women with self-perceived bad health. CONCLUSIONS: Mean lipid levels measured after childbirth in women with one child were significantly higher compared to mothers with two or more children and were associated with higher probability of having only one child. These findings corroborate an association between serum lipid levels and one lifetime pregnancy (as a feature of subfecundity), emphasizing that these particular women may be a specific predetermined risk group for cardiovascular related disease and death.

Risk of having one lifetime pregnancy and modification by outcome of pregnancy and perinatal loss.

INTRODUCTION: With increasing cesarean section rates, adverse pregnancy outcomes such as preterm delivery and small-for-gestational-age continue to be public health challenges. Besides having high co-occurrence and interrelation, it is suggested that these outcomes, along with preeclampsia, are associated with reduced subsequent fertility. On the other hand, the loss of a child during the perinatal period is associated with increased reproduction. Failure to consider this factor when estimating the effects of pregnancy outcomes on future reproduction may lead to erroneous conclusions. However, few studies have explored to what degree a perinatal loss contributes to having a next pregnancy in various adverse pregnancy outcomes. MATERIAL AND METHODS: This was a population-based study of mothers giving birth to their first singleton infant (≥22 gestational weeks) during 1967-2007 who were followed for the occurrence of a second birth in the Medical Birth Registry of Norway until 2014. Relative risks with 95% confidence intervals for having one lifetime pregnancy by preterm delivery, small-for-gestational-age, preeclampsia and cesarean section were obtained by generalized linear models for the binary family and adjusted for maternal age at first birth, education and year of first childbirth. Main outcome measure was having one lifetime pregnancy. RESULTS: Nearly 900 000 women gave birth to their first singleton infant in 1967-2007, of which 16% had only one lifetime pregnancy. These women were older at first delivery, had less education and there was a higher proportion of unmarried women than women with two or more births. In women with pregnancy complications where the infant survived the perinatal period, there were the following relative risks for one lifetime pregnancy: increased preterm delivery: 1.21 (1.19-1.22)], small-for-gestational-age: 1.13 (1.12-1.15), preeclampsia: 1.09 (1.07-1.11), cesarean section: 1.24 (1.23-1.25). The risk was significantly reduced if the child was lost (preterm delivery: 0.63 [0.59-0.68], small-for-gestational-age: 0.57 [0.51-0.63], preeclampsia: 0.69 [0.59-0.80], cesarean section: 0.67 [0.56-0.79]), compared with women with no perinatal loss and no adverse outcome. CONCLUSIONS: The associations between adverse outcomes of pregnancy and the risk of having one lifetime pregnancy were strongly modified by child survival in the perinatal period.

Women's prepregnancy lipid levels and number of children: a Norwegian prospective population-based cohort study.

OBJECTIVE: To study prepregnancy serum lipid levels and the association with the number of children. DESIGN: Prospective, population-based cohort. SETTING: Linked data from the Cohort of Norway and the Medical Birth Registry of Norway. PARTICIPANTS: 2645 women giving birth to their first child during 1994-2003 (488 one-child mothers and 2157 women with ≥2 births) and 1677 nulliparous women. MAIN OUTCOME MEASURES: ORs for no and one lifetime pregnancy (relative to ≥2 pregnancies) obtained by multinomial logistic regression, adjusted for age at examination, education, body mass index (BMI), smoking, time since last meal and oral contraceptive use. RESULTS: Assessed in quintiles, higher prepregnant triglyceride (TG) and TG to high-density lipoprotein (TG:HDL-c) ratio levels were associated with increased risk of one lifetime pregnancy compared with having ≥2 children. Compared with the highest quintile, women in the lowest quintile of HDL cholesterol levels had an increased risk of one lifetime pregnancy (OR 1.7, 95% CI 1.2 to 2.4), as were women with the highest low-density lipoprotein (LDL) cholesterol, TG and TG:HDL-c ratio quintiles (compared with the lowest) (OR 1.2, 95% CI 0.8 to 1.7; OR 2.2, 95% CI 1.5 to 3.2; and OR 2.2, 95% CI 1.5 to 3.2, respectively). Similar effects were found in women with BMI≥25 and the highest LDL and total cholesterol levels in risk of lifetime nulliparity. CONCLUSION: Women with unfavourable prepregnant lipid profile had higher risk of having no or only one child. These findings substantiate an association between prepregnant serum lipid levels and number of children. Previously observed associations between low parity and increased cardiovascular mortality may in part be due to pre-existing cardiovascular disease lipid risk factors.

Children's health risk assessment based on the content of toxic metals Pb, Cd, Cu and Zn in urban soil samples of Podgorica, Montenegro.

BACKGROUND/AIM: Due to their low tolerance to pollutants and hand-to-mouth pathways the health risk is very high in children's population. The aim of this study was to evaluate risk to children's health based on the content of heavy metals in urban soil samples from Podgorica, Montenegro. This study included the investigation of several toxic metals such as Pb, Cd, Cu and Zn in soil samples from public parks and playgrounds. METHODS: Sampling was conducted in a period October-November, 2012. Based on cluster analysis, soil samples were divided into two groups related to similarity of metal content at examinated locations: the group I--near by recreational or residential areas of the city, and the group II--near traffic roads. Concentration of toxic metals, in urban soil samples were determined by a graphite furnace atomic absorption spectrometry (Pb and Cd) and by inductively coupled plasma optical emission spectrometry technique after microwave digestion. Due to exposure to urban soil, non-cancerogenic index hazardous index (HI) for children was estimated using 95th percentile values of total metal concentration. The value of the total (ingestion, dermal and inhalation) HI is calculated for maximum, minimum and the average concentration of metals for children. RESULTS: Mean concentrations of Pb, Cd, Cu and Zn in the surface layer of the studied urban soils were 85.91 mg/kg, 2.8 mg/kg and 52.9 mg/kg and 112.5 mg/kg, respectively. Samples from group II showed higher metal content compared to group I. Urbanization and traffic are the main sources of pollution of the urban soils of Podgorica. Most of the samples (93.5%) had a high Pb content, 12.9% of the samples had a higher content of Cd, while Cu and Zn were within the limits prescribed by national legislation. At one location the level of security for lead is HI = 0.8 and very closed to maximum acceptable value of 1. It is probably the result of intensive traffic near by. CONCLUSION: All metals investigated showed relatively higher concentrations at sites that were close to industrial places and high ways. The mean concentrations of Pb and Zn and maximum concentrations of Pb, Cd, and Zn were higher than presented values in the National Regulation.