| 1. |
- Andersson, Ola, et al.
(author)
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Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months : a randomised controlled trial
- 2011
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In: BMJ. British Medical Journal. - : BMJ, british Medical Association. - 0959-8146 .- 0959-535X. ; 343, s. d7157-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To investigate the effects of delayed umbilical cord clamping, compared with early clamping, on infant iron status at 4 months of age in a European setting. DESIGN: Randomised controlled trial. SETTING: Swedish county hospital. PARTICIPANTS: 400 full term infants born after a low risk pregnancy. INTERVENTION: Infants were randomised to delayed umbilical cord clamping (≥180 seconds after delivery) or early clamping (≤10 seconds after delivery). MAIN OUTCOME MEASURES: Haemoglobin and iron status at 4 months of age with the power estimate based on serum ferritin levels. Secondary outcomes included neonatal anaemia, early respiratory symptoms, polycythaemia, and need for phototherapy. RESULTS: At 4 months of age, infants showed no significant differences in haemoglobin concentration between the groups, but infants subjected to delayed cord clamping had 45% (95% confidence interval 23% to 71%) higher mean ferritin concentration (117 μg/L v 81 μg/L, P<0.001) and a lower prevalence of iron deficiency (1 (0.6%) v 10 (5.7%), P=0.01, relative risk reduction 0.90; number needed to treat=20 (17 to 67)). As for secondary outcomes, the delayed cord clamping group had lower prevalence of neonatal anaemia at 2 days of age (2 (1.2%) v 10 (6.3%), P=0.02, relative risk reduction 0.80, number needed to treat 20 (15 to 111)). There were no significant differences between groups in postnatal respiratory symptoms, polycythaemia, or hyperbilirubinaemia requiring phototherapy. CONCLUSIONS: Delayed cord clamping, compared with early clamping, resulted in improved iron status and reduced prevalence of iron deficiency at 4 months of age, and reduced prevalence of neonatal anaemia, without demonstrable adverse effects. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants even in regions with a relatively low prevalence of iron deficiency anaemia. Trial registration Clinical Trials NCT01245296.
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| 2. |
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| 3. |
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| 4. |
- Johnsson, Linus, et al.
(author)
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Patients' refusal to consent to storage and use of samples in Swedish biobanks : cross sectional study
- 2008
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 337:7663, s. a345-
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Journal article (peer-reviewed)abstract
- ObjectivesTo estimate how many people object to storage of biological samples collected in health care in Sweden and to their use in research and how many withdraw previous consent.DesignCross sectional study of register data.SettingBiobanks used in Swedish health care, 2005-6.PopulationData on refusal to consent were obtained for 1.4 million biobank samples per year from 20 of 21 counties.Main outcome measuresRates of preliminary refusal to consent, confirmed refusal, and withdrawal of consent.ResultsPatients refused consent to either storage or use of their samples in about 1 in 690 cases, about 1 in 1600 confirmed their decision by completing a dissent form. Rather than having the samples destroyed, about 1 in 6200 patients wanted to restrict their use. Of those who had previously consented, about 1 in 19 000 withdrew their consent.ConclusionsRefusal to consent to biobank research in Sweden is rare, and the interests of individuals and research interests need not be at odds. The Swedish healthcare organisation is currently obliged to obtain either consent or refusal to each potential use of each sample taken, and tack of consent to research is used as the default position. A system of presumed consent with straightforward opt out;would correspond with people's attitudes, as expressed in their actions, towards biobank research.
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| 5. |
- Merino, Jordi, et al.
(author)
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Quality of dietary fat and genetic risk of type 2 diabetes : individual participant data meta-analysis
- 2019
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 366
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Journal article (peer-reviewed)abstract
- OBJECTIVE To investigate whether the genetic burden of type 2 diabetes modifies the association between the quality of dietary fat and the incidence of type 2 diabetes.DESIGN Individual participant data meta-analysis.DATA SOURCES Eligible prospective cohort studies were systematically sourced from studies published between January 1970 and February 2017 through electronic searches in major medical databases (Medline, Embase, and Scopus) and discussion with investigators.REVIEW METHODS Data from cohort studies or multicohort consortia with available genome-wide genetic data and information about the quality of dietary fat and the incidence of type 2 diabetes in participants of European descent was sought. Prospective cohorts that had accrued five or more years of follow-up were included. The type 2 diabetes genetic risk profile was characterized by a 68-variant polygenic risk score weighted by published effect sizes. Diet was recorded by using validated cohort-specific dietary assessment tools. Outcome measures were summary adjusted hazard ratios of incident type 2 diabetes for polygenic risk score, isocaloric replacement of carbohydrate (refined starch and sugars) with types of fat, and the interaction of types of fat with polygenic risk score.RESULTS Of 102 305 participants from 15 prospective cohort studies, 20 015 type 2 diabetes cases were documented after a median follow-up of 12 years (interquartile range 9.4-14.2). The hazard ratio of type 2 diabetes per increment of 10 risk alleles in the polygenic risk score was 1.64 (95% confidence interval 1.54 to 1.75, I-2 = 7.1%, tau(2) = 0.003). The increase of polyunsaturated fat and total omega 6 polyunsaturated fat intake in place of carbohydrate was associated with a lower risk of type 2 diabetes, with hazard ratios of 0.90 (0.82 to 0.98, I-2 = 18.0%, tau(2) = 0.006; per 5% of energy) and 0.99 (0.97 to 1.00, I-2 = 58.8%, tau(2) = 0.001; per increment of 1 g/d), respectively. Increasing monounsaturated fat in place of carbohydrate was associated with a higher risk of type 2 diabetes (hazard ratio 1.10, 95% confidence interval 1.01 to 1.19, I-2 = 25.9%, tau(2) = 0.006; per 5% of energy). Evidence of small study effects was detected for the overall association of polyunsaturated fat with the risk of type 2 diabetes, but not for the omega 6 polyunsaturated fat and monounsaturated fat associations. Significant interactions between dietary fat and polygenic risk score on the risk of type 2 diabetes (P>0.05 for interaction) were not observed.CONCLUSIONS These data indicate that genetic burden and the quality of dietary fat are each associated with the incidence of type 2 diabetes. The findings do not support tailoring recommendations on the quality of dietary fat to individual type 2 diabetes genetic risk profiles for the primary prevention of type 2 diabetes, and suggest that dietary fat is associated with the risk of type 2 diabetes across the spectrum of type 2 diabetes genetic risk.
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| 6. |
- Neovius, Martin, et al.
(author)
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Combined effects of overweight and smoking in late adolescence on subsequent mortality : nationwide cohort study
- 2009
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 338, s. b496-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To investigate the combined effects on adult mortality of overweight and smoking in late adolescence. DESIGN: Record linkage study with Cox proportional hazard ratios adjusted for muscle strength, socioeconomic position, and age. SETTING: Swedish military service conscription register, cause of death register, and census data. PARTICIPANTS: 45 920 Swedish men (mean age 18.7, SD 0.5) followed for 38 years. MAIN OUTCOME MEASURES: Body mass index (underweight (BMI <18.5), normal weight (18.5-24.9), overweight (25-29.9), and obesity (>or=30)), muscle strength, and self reported smoking (non-smoker, light smoker (1-10 cigarettes/day), heavy smoker (>10/day)) at mandatory military conscription tests in 1969-70. All cause mortality. RESULTS: Over 1.7 million person years, 2897 men died. Compared with normal weight men (incidence rate 17/10 000 person years, 95% confidence interval 16 to 18), risk of mortality was increased in overweight (hazard ratio 1.33, 1.15 to 1.53; incidence rate 23, 20 to 26) and obese men (hazard ratio 2.14, 1.61 to 2.85; incidence rate 38, 27 to 48), with similar relative estimates in separate analyses of smokers and non-smokers. No increased risk was detected in underweight men (hazard ratio 0.97, 0.86 to 1.08; incidence rate 18, 16 to 19), though extreme underweight (BMI <17) was associated with increased mortality (hazard ratio 1.33, 1.07 to 1.64; incidence rate 24, 19 to 29). The relative excess risk due to interaction between BMI and smoking status was not significant in any stratum. Furthermore, all estimates of interaction were of small magnitude, except for the combination of obesity and heavy smoking (relative excess risk 1.5, -0.7 to 3.7). Compared with non-smokers (incidence rate 14, 13 to 15), risk was increased in both light (hazard ratio 1.54, 1.41 to 1.70; incidence rate 15, 14 to 16) and heavy smokers (hazard ratio 2.11, 1.92 to 2.31; incidence rate 26, 24 to 27). CONCLUSIONS: Regardless of smoking status, overweight and obesity in late adolescence increases the risk of adult mortality. Obesity and overweight were as hazardous as heavy and light smoking, respectively, but there was no interaction between BMI and smoking status. The global obesity epidemic and smoking among adolescents remain important targets for intensified public health initiatives.
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| 7. |
- Nordin, Pär, et al.
(author)
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Volume of procedures and risk of recurrence after repair of groin hernia : national register study
- 2008
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In: BMJ. British Medical Journal. - : BMJ Group. - 0959-8146 .- 0959-535X. ; 336:7650, s. 934-937
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To determine whether the association between volume and outcome found in major surgery also holds true for a minor operation. DESIGN: Review of outcomes after hernia surgery in Sweden.SETTING: Surgical units registered with the Swedish hernia register, which in 2004 covered about 95% of all hernia operations in Sweden.PARTICIPANTS: 86,409 patients over 15 years, who underwent 96,601 unilateral or bilateral groin hernia repairs (94,077 inguinal and 2524 femoral) in 1996-2004 at the participating surgical units.MAIN OUTCOME MEASURE: Re-operation for recurrence.RESULTS: There was a significantly higher rate of re-operation in surgeons who carried out 1-5 repairs a year than in surgeons who carried out more repairs. There was no association between outcome and further increases in volume. Although about half of surgeons in Sweden who repair hernias are low volume operators, they performed only 8.4% of all repairs.CONCLUSIONS: Sweden's numerous low volume hernia surgeons perform such a small proportion of all operations that the impact of their inferior results on the nationwide re-operation rate is minimal. Volume indicates an approximate minimum value for the number of hernia repairs a surgeon should do each year but the outcome in surgeons who carry out more than that number disqualifies volume as an indicator of proficiency.
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| 8. |
- Osika, Walter, et al.
(author)
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Physical control and coordination in childhood and adult obesity : longitudinal birth cohort study
- 2008
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 337, s. a699-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To identify whether measures of childhood physical control and coordination as markers of neurological function are associated with obesity in adults. DESIGN: Longitudinal birth cohort study. SETTING: National child development study in Great Britain. PARTICIPANTS: 11,042 people born during one week in 1958. MAIN OUTCOME MEASURE: Obesity at age 33 years defined as body mass index >or=30. RESULTS: Among 7990 cohort members at age 7 years, teachers reported that poor hand control, poor coordination, and clumsiness "certainly applied" more often among those who would be obese adults, producing adjusted odds ratios of 1.57 (95% confidence interval 1.13 to 2.20; P=0.008) for poor hand control, 2.30 (1.52 to 3.46; P<0.001) for poor coordination, and 3.91 (2.61 to 5.87; P<0.001) for clumsiness. Among 6875 participants who had doctor administered assessments with continuous scores at age 11 years, poorer function was associated with later obesity, indicated by adjusted odds ratios (change in risk per unit increase in score) of 0.88 (0.81 to 0.96; P=0.003) for copying designs, 0.84 (0.78 to 0.91; P<0.001) for marking squares, and 1.14 (1.06 to 1.24; P<0.001) for picking up matches (a higher score indicates poor function in this test). Further adjustment for contemporaneous body mass index at age 7 or 11 years did not eliminate statistical significance for any of the associations. CONCLUSION: Some aspects of poorer neurological function associated with adult obesity may have their origins in childhood.
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| 9. |
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| 10. |
- Virtanen, Marianna, et al.
(author)
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Long working hours and alcohol use : systematic review and meta-analysis of published studies and unpublished individual participant data.
- 2015
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In: BMJ (Clinical research ed.). - : BMJ. - 1756-1833 .- 0959-8138. ; 350, s. Art. no. g7772-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To quantify the association between long working hours and alcohol use.DESIGN: Systematic review and meta-analysis of published studies and unpublished individual participant data.DATA SOURCES: A systematic search of PubMed and Embase databases in April 2014 for published studies, supplemented with manual searches. Unpublished individual participant data were obtained from 27 additional studies.REVIEW METHODS: The search strategy was designed to retrieve cross sectional and prospective studies of the association between long working hours and alcohol use. Summary estimates were obtained with random effects meta-analysis. Sources of heterogeneity were examined with meta-regression.RESULTS: Cross sectional analysis was based on 61 studies representing 333 693 participants from 14 countries. Prospective analysis was based on 20 studies representing 100 602 participants from nine countries. The pooled maximum adjusted odds ratio for the association between long working hours and alcohol use was 1.11 (95% confidence interval 1.05 to 1.18) in the cross sectional analysis of published and unpublished data. Odds ratio of new onset risky alcohol use was 1.12 (1.04 to 1.20) in the analysis of prospective published and unpublished data. In the 18 studies with individual participant data it was possible to assess the European Union Working Time Directive, which recommends an upper limit of 48 hours a week. Odds ratios of new onset risky alcohol use for those working 49-54 hours and ≥55 hours a week were 1.13 (1.02 to 1.26; adjusted difference in incidence 0.8 percentage points) and 1.12 (1.01 to 1.25; adjusted difference in incidence 0.7 percentage points), respectively, compared with working standard 35-40 hours (incidence of new onset risky alcohol use 6.2%). There was no difference in these associations between men and women or by age or socioeconomic groups, geographical regions, sample type (population based v occupational cohort), prevalence of risky alcohol use in the cohort, or sample attrition rate.CONCLUSIONS: Individuals whose working hours exceed standard recommendations are more likely to increase their alcohol use to levels that pose a health risk.
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| 11. |
- Bergendahl, Sandra, et al.
(author)
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Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA) : multicentre, open label, randomised controlled trial
- 2024
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 385, s. e079014-
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Journal article (peer-reviewed)abstract
- Objective: To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction. Design: A multicentre, open label, randomised controlled trial.Setting: Eight hospitals in Sweden, 2017-23.Participants: 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by study site.Intervention: A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable.Main outcome measures: The primary outcome of the episiotomy in vacuum assisted delivery (EVA) trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI).Results: From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was -7.0% (96% CI -11.7% to -2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence.Conclusions: Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury. Trial registration: ClinicalTrials.gov NCT02643108.
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| 12. |
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| 13. |
- Hohenschurz-Schmidt, David, et al.
(author)
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Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies : the CoPPS Statement
- 2023
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 381, s. e072108-
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Journal article (peer-reviewed)abstract
- Control interventions (often called "sham," "placebo," or "attention controls") are essential for studying the efficacy or mechanism of physical, psychological, and self-management interventions in clinical trials. This article presents core recommendations for designing, conducting, and reporting control interventions to establish a quality standard in non-pharmacological intervention research. A framework of additional considerations supports researchers' decision making in this context. We also provide a reporting checklist for control interventions to enhance research transparency, usefulness, and rigour.
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| 14. |
- Holmberg, Dag, et al.
(author)
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Non-erosive gastro-oesophageal reflux disease and incidence of oesophageal adenocarcinoma in three Nordic countries : population based cohort study
- 2023
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 382, s. e076017-
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Journal article (peer-reviewed)abstract
- Objective To assess the incidence rate of oesophageal adenocarcinoma among patients with non-erosive gastro-oesophageal reflux disease compared with the general population.Design Population based cohort study.Setting All patients in hospital and specialised outpatient healthcare in Denmark, Finland, and Sweden from 1 January 1987 to 31 December 2019.Participants 486 556 adults (>18 years) who underwent endoscopy were eligible for inclusion: 285 811 patients were included in the non-erosive gastro-oesophageal reflux disease cohort and 200 745 patients in the validation cohort with erosive gastro-oesophageal reflux disease.Exposures Non-erosive gastro-oesophageal reflux disease was defined by an absence of oesophagitis and any other oesophageal diagnosis at endoscopy. Erosive gastro-oesophageal reflux disease was examined for comparison reasons and was defined by the presence of oesophagitis at endoscopy.Main outcome measures The incidence rate of oesophageal adenocarcinoma was assessed for up to 31 years of follow-up. Standardised incidence ratios with 95% confidence intervals were calculated by dividing the observed number of oesophageal adenocarcinomas in each of the gastro-oesophageal reflux disease cohorts by the expected number, derived from the general populations in Denmark, Finland, and Sweden of the corresponding age, sex, and calendar period.Results Among 285 811 patients with non-erosive gastro-oesophageal reflux disease, 228 developed oesophageal adenocarcinomas during 2 081 051 person-years of follow-up. The incidence rate of oesophageal adenocarcinoma in patients with non-erosive gastro-oesophageal reflux disease was 11.0/100 000 person-years. The incidence was similar to that of the general population (standardised incidence ratio 1.04 (95% confidence interval 0.91 to 1.18)), and did not increase with longer follow-up (1.07 (0.65 to 1.65) for 15-31 years of follow-up). For validity reasons, we also analysed people with erosive oesophagitis at endoscopy (200 745 patients, 1 750 249 person-years, and 542 oesophageal adenocarcinomas, corresponding to an incidence rate of 31.0/100 000 person-years) showing an increased overall standardised incidence ratio of oesophageal adenocarcinoma (2.36 (2.17 to 2.57)), which became more pronounced with longer follow-up.Conclusions Patients with non-erosive gastro-oesophageal reflux disease seem to have a similar incidence of oesophageal adenocarcinoma as the general population. This finding suggests that endoscopically confirmed non-erosive gastro-oesophageal reflux disease does not require additional endoscopic monitoring for oesophageal adenocarcinoma.
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| 15. |
- Johansson, Minna, et al.
(author)
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Estimating overdiagnosis in screening for abdominal aortic aneurysm : could a change in smoking habits and lowered aortic diameter tip the balance of screening towards harm?
- 2015
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In: BMJ-BRITISH MEDICAL JOURNAL. - : B M J Group. - 1756-1833 .- 0959-8146 .- 0959-535X. ; 350
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Journal article (peer-reviewed)abstract
- Clinical context—Abdominal aortic aneurysms (AAAs) are often asymptomatic until they rupture, when the death rate is greater than 80%. If diagnosed before rupture, AAA can be treated with surgery, which has a mortality of 4-5% Diagnostic change— Sweden, the UK, and the US have initiated screening programmes for AAA. There are also proposals to change the aortic diameter for diagnosis from ≥30 mm to 25 mm Rationale for change—Early diagnosis by screening allows the opportunity of surgery to prevent ruptures Leap of faith—Detecting asymptomatic aneurysms will reduce AAA mortality and morbidity Impact on prevalence—Our estimates indicate that screening almost doubles AAA prevalence, but most AAAs are small and at low risk of rupture. Changing the definition of an AAA from 30 mm to 25 mm would double prevalence again Evidence of overdiagnosis—We estimate that if 10 000 men are invited to screening, 46 AAA deaths can be prevented over 13-15 years but 176 would have an AAA ≥30 mm detected that remained asymptomatic after 13 years. A recent drop in AAA prevalence reduces the benefits of screening and worsens the benefit:harm ratio Harms of overdiagnosis—Asymptomatic men are labelled at risk of a life threatening condition for which they will be under lifelong surveillance. Of 10 000 men invited to AAA screening, 37 (95% confidence interval 15 to 60) overdiagnosed men had unnecessary preventive surgery, of whom 1.6 (1.4 to 1.7) died Limitations—Figures for exact calculations of overdiagnosis are not available and unlikely to emerge. The psychosocial consequences of living with a screen detected AAA are inadequately investigated. Cost effectiveness data on screening are inconclusive Conclusion— Screening programmes have changed the meaning of an AAA diagnosis from a life threatening condition to a risk factor. AAA screening programmes should be revisited because of reduced benefits in modern populations and because data suggest considerable harm
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| 16. |
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| 17. |
- Ljung, Rickard, et al.
(author)
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Association between SARS-CoV-2 vaccination and healthcare contacts for menstrual disturbance and bleeding in women before and after menopause: nationwide, register based cohort study.
- 2023
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In: BMJ (Clinical research ed.). - : BMJ Publishing Group Ltd. - 0959-535X .- 1756-1833 .- 0959-8146. ; 381
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Journal article (peer-reviewed)abstract
- To evaluate the risks of any menstrual disturbance and bleeding following SARS-CoV-2 vaccination in women who are premenopausal or postmenopausal.A nationwide, register based cohort study.All inpatient and specialised outpatient care in Sweden from 27 December 2020 to 28 February 2022. A subset covering primary care for 40% of the Swedish female population was also included.2946448 Swedish women aged 12-74 years were included. Pregnant women, women living in nursing homes, and women with history of any menstruation or bleeding disorders, breast cancer, cancer of female genital organs, or who underwent a hysterectomy between 1 January 2015 and 26 December 2020 were excluded.SARS-CoV-2 vaccination, by vaccine product (BNT162b2, mRNA-1273, or ChAdOx1 nCoV-19 (AZD1222)) and dose (unvaccinated and first, second, and third dose) over two time windows (one to seven days, considered the control period, and 8-90 days).Healthcare contact (admission to hospital or visit) for menstrual disturbance or bleeding before or after menopause (diagnosed with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes N91, N92, N93, N95).2580007 (87.6%) of 2946448 women received at least one SARS-CoV-2 vaccination and 1652472 (64.0%) 2580007 of vaccinated women received three doses before the end of follow-up. The highest risks for bleeding in women who were postmenopausal were observed after the third dose, in the one to seven days risk window (hazard ratio 1.28 (95% confidence interval 1.01 to 1.62)) and in the 8-90 days risk window (1.25 (1.04 to 1.50)). The impact of adjustment for covariates was modest. Risk of postmenopausal bleeding suggested a 23-33% increased risk after 8-90 days with BNT162b2 and mRNA-1273 after the third dose, but the association with ChAdOx1 nCoV-19 was less clear. For menstrual disturbance or bleeding in women who were premenopausal, adjustment for covariates almost completely removed the weak associations noted in the crude analyses.Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal. These findings do not provide substantial support for a causal association between SARS-CoV-2 vaccination and healthcare contacts related to menstrual or bleeding disorders.
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| 18. |
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| 19. |
- Ludvigsson, Jonas F., 1969-, et al.
(author)
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Maternal vaccination against H1N1 influenza and offspring mortality : population based cohort study and sibling design
- 2015
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In: BMJ. British Medical Journal. - London, United Kingdom : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 351
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Journal article (peer-reviewed)abstract
- Study question: What is the mortality in offspring of mothers who hadinfluenza A(H1N1)pdm09 vaccination during pregnancy?Methods: This was a prospective population based cohort study in seven healthcare regions in Sweden based on vaccinations taking place between 2 October 2009 and 26 November 2010. H1N1 vaccination data were linked with pregnancy and birth characteristics and offspring mortality data in 275 500 births (of which 1203 were stillbirths) from 137 886 mothers. Of these offspring, 41 183 had been exposed to vaccination with Pandemrix, a monovalent AS03 adjuvanted H1N1 influenza vaccine, during fetal life. A primary comparison group consisted of pregnancies of women who were not vaccinated during the same calendar period. In a second comparison, non-exposed siblings of infants prenatally exposed to vaccination were used as controls. Cox regression was used to estimate hazard ratios for stillbirth, early neonatal mortality (days 0-6 after birth), and subsequent mortality (beginning on day 7) in vaccinated versus nonvaccinated women, adjusting for mother’s age at delivery, body mass index, parity, smoking, country of birth, and disposable income and for sex of offspring.Study answer and limitations: The results of this study suggest that AS03 adjuvanted H1N1 vaccination during pregnancy does not affect the risk of stillbirth, early neonatal death, or later mortality in the offspring. During follow-up, 1172 stillbirths, 380 early neonatal deaths, and 706 deaths thereafter occurred. Compared with general population controls, this corresponded to adjusted hazard ratios of 0.83 (95% confidence interval 0.65 to 1.04) for stillbirth, 0.71 (0.44 to 1.14) for early neonatal death, and 0.97 (0.69 to 1.36) for later death. When siblings were used as controls, adjusted hazard ratios were 0.88 (0.59 to 1.30) for stillbirth, 0.82 (0.46 to 1.49) for early neonatal death, and 0.78 (0.52 to 1.19) for later death. Limitations of the study include lack of data on miscarriage before gestational week 22, inability to ascertain which mothers had pandemic flu during pregnancy, and lack of data on factors influencing the decision to vaccinate during pregnancy.What this study adds: H1N1 vaccination during pregnancy is not associated with adverse fetal outcome or offspring mortality, including when familial factors are taken into account.
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| 20. |
- Martikainen, Pekka, et al.
(author)
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Heavy metal toxicity and mortality-association between density of heavy metal bands and cause specific hospital admissions and mortality : population based cohort study
- 2021
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 375
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Journal article (peer-reviewed)abstract
- OBJECTIVE To assess the association between area level density of heavy metal bands and cause specific hospital admissions and mortality.DESIGN Longitudinal register based cohort study.SETTING311 municipalities in Finland.PARTICIPANTS3 644 944 people aged 15 to 70 residing in Finland at the end of 2001.MAIN OUTCOME MEASURESHospital admission and mortality from all causes, internal causes, alcohol attributable causes, accidental injury and violence, suicide or self-harm, and mental health related causes. Appendicitis and toxic effects of metals were negative control outcomes.RESULTS During 50.4 million person years of follow-up in 2002-17, 4 237 807 person years with hospital admissions were observed and 221 912 individuals died. Mortality in municipalities with a moderate density of heavy metal bands (<5.7 per 10 000 inhabitants) was lower than in municipalities with no heavy metal bands. Hospital admission rates were lower in municipalities with heavy metal bands compared with those with none. These associations could be explained partly by differences in the sociodemographic characteristics of residents in these municipalities. After adjustment for individual characteristics and area level cultural and economic characteristics-proportion of the population with no religious affiliation, unemployment rate, and per capita expenditure on culture and education-large cities with a high density of heavy metal bands (8.2-11.2 per 10 000) showed a mortality advantage (hazard ratio 0.92, 95% confidence interval 0.88 to 0.96). In contrast, the association for hospital admission was fully attenuated (incidence rate ratio 0.99, 95% confidence interval 0.92 to 1.06). The cause specific analysis showed similar results, with the association most pronounced for alcohol attributable mortality (hazard ratio 0.83, 95% confidence interval 0.75 to 0.93 for cities with a high density of heavy metal bands) and alcohol attributable hospital admissions (incidence rate ratio 0.84, 95% confidence interval 0.74 to 0.97 for cities with a high density of heavy metal bands) in the fully adjusted models. No association with heavy metal band density was found for the analysis using appendicitis as a negative control outcome.CONCLUSIONS The study found no evidence for adverse health outcomes with increasing density of heavy metal bands. Cities with a high density of heavy metal bands showed slightly lower rates of mortality and of hospital admissions for alcohol related problems and self-harm. Although residual confounding remains a problem in observational studies, vibrant local heavy metal scenes-comparable to many other forms of cultural capital-might help to promote health through healthier lifestyles, better coping mechanisms, and a stronger sense of community.
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| 21. |
- Nelson, Eugene C., et al.
(author)
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Patient focused registries can improve health, care, and science
- 2016
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 354
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Journal article (peer-reviewed)abstract
- Large scale collection and analysis of data on patients’ experiences and outcomes have become staples of successful health systems worldwide. The systems go by various names—including registries, quality registries, clinical databases, clinical audits, and quality improvement programmes—but all collect standardised information on patients’ diagnoses, care processes, and outcomes, enabling systematic comparison and analysis across multiple sites. Hundreds of what we will term, for simplicity, “registries,” now exist around the world. The United Kingdom is home to over 50 clinical audit programmes, the United States has over 110 federally qualified registries certified to report quality metrics, and Sweden, perhaps the registry epicentre, has over 100, covering conditions from birth to frail old age.These registries have had far reaching effects. They facilitate public reporting, retrospective and prospective research, professional development, and service improvement. They reveal variations in practices, processes, and outcomes, and identify targets for improvement. In the UK, they have been associated with many notable successes, including improvements in management of cardiovascular disease and stroke, cancer, and joint replacement.
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| 22. |
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| 23. |
- Ong, Kwok Leung, et al.
(author)
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Association of omega 3 polyunsaturated fatty acids with incident chronic kidney disease : pooled analysis of 19 cohorts
- 2023
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 380
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To assess the prospective associations of circulating levels of omega 3 polyunsaturated fatty acid (n-3 PUFA) biomarkers (including plant derived a linolenic acid and seafood derived eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid) with incident chronic kidney disease (CKD).DESIGN: Pooled analysis.DATA SOURCES: A consortium of 19 studies from 12 countries identified up to May 2020.STUDY SELECTION: Prospective studies with measured n-3 PUFA biomarker data and incident CKD based on estimated glomerular filtration rate.DATA EXTRACTION AND SYNTHESIS: Each participating cohort conducted de novo analysis with prespecified and consistent exposures, outcomes, covariates, and models. The results were pooled across cohorts using inverse variance weighted meta-analysis.MAIN OUTCOME MEASURES: Primary outcome of incident CKD was defined as new onset estimated glomerular filtration rate <60 mL/ min/1.73 m(2). In a sensitivity analysis, incident CKD was defined as new onset estimated glomerular filtration rate <60 mL/min/1.73 m(2) and <75% of baseline rate.RESULTS: 25 570 participants were included in the primary outcome analysis and 4944 (19.3%) developed incident CKD during follow-up (weighted median 11.3 years). In multivariable adjusted models, higher levels of total seafood n-3 PUFAs were associated with a lower incident CKD risk (relative risk per interquintile range 0.92, 95% confidence interval 0.86 to 0.98; P=0.009, I-2=9.9%). In categorical analyses, participants with total seafood n-3 PUFA level in the highest fifth had 13% lower risk of incident CKD compared with those in the lowest fifth (0.87, 0.80 to 0.96; P=0.005, I-2=0.0%). Plant derived a linolenic acid levels were not associated with incident CKD (1.00, 0.94 to 1.06; P=0.94, I-2=5.8%). Similar results were obtained in the sensitivity analysis. The association appeared consistent across subgroups by age (=60 v <60 years), estimated glomerular filtration rate (60-89 v =90 mL/min/1.73 m(2)), hypertension, diabetes, and coronary heart disease at baseline.CONCLUSIONS: Higher seafood derived n-3 PUFA levels were associated with lower risk of incident CKD, although this association was not found for plant derived n-3 PUFAs. These results support a favourable role for seafood derived n-3 PUFAs in preventing CKD.
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| 24. |
- Raaschou, Pauline, et al.
(author)
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Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma : nationwide population based prospective cohort study from Sweden
- 2013
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 346
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To investigate the potential association between tumour necrosis factor (TNF) inhibitor treatment and malignant melanomas in rheumatoid arthritis, melanoma risks in rheumatoid arthritis patients not treated with biological drugs, and risk of all site cancer with TNF inhibitors as used in rheumatoid arthritis.DESIGN: Population based cohort study.SETTING: Prospectively recorded data from national clinical, health, and demographic registers in Sweden 2001-10. Patients with rheumatoid arthritis treated (n = 10,878) or not (n = 42,198) with TNF inhibitors and matched general population comparators (n = 162,743).MAIN OUTCOME MEASURES: The primary outcome was first invasive melanoma in people without any history of invasive cancer of any type. Hazard ratios were estimated using Cox regression, comparing non-biological drug treated rheumatoid arthritis patients with the general population comparator and TNF inhibitor treated rheumatoid arthritis patients with those not treated with biological drugs. Secondary outcomes included in situ melanomas, second primary melanomas, and all site cancer.RESULTS: 113 first invasive melanomas occurred in rheumatoid arthritis patients not treated with biological drugs, and 393 occurred in the general population comparator cohort. Rheumatoid arthritis patients not treated with biological drugs were not at significantly increased risk of melanoma compared with the general population (hazard ratio 1.2, 95% confidence interval 0.9 to 1.5). 38 first invasive melanomas occurred in rheumatoid arthritis patients treated with TNF inhibitors; these patients had an increased risk of melanoma compared with rheumatoid arthritis patients not treated with biological drugs (hazard ratio 1.5, 1.0 to 2.2; 20 additional cases per 100,000 person years). The risk of a second primary melanoma was non-significantly increased (hazard ratio 3.2, 0.8 to 13.1; n=3 v 10) in rheumatoid arthritis patients treated with TNF inhibitors compared with those not treated with biological drugs.CONCLUSION: Overall, patients with rheumatoid arthritis who have not been treated with biological drugs are not at increased risk of invasive melanoma compared with the general population. Rheumatoid arthritis patients selected for TNF inhibitor treatment are not at increased overall risk for cancer but have a 50% increased relative risk of invasive melanoma. Given the small increase in absolute risk, these finding may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons.
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| 25. |
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| 26. |
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| 27. |
- Sandblom, Gabriel, et al.
(author)
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Randomised prostate cancer screening trial: 20 year follow-up
- 2011
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In: BRITISH MEDICAL JOURNAL. - : B M J PUBLISHING GROUP, BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 9JR, ENGLAND. - 0959-535X. ; 342:d1539
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Journal article (peer-reviewed)abstract
- Objective To assess whether screening for prostate cancer reduces prostate cancer specific mortality. Design Population based randomised controlled trial. Setting Department of Urology, Norrkoping, and the South-East Region Prostate Cancer Register. Participants All men aged 50-69 in the city of Norrkoping, Sweden, identified in 1987 in the National Population Register (n=9026). Intervention From the study population, 1494 men were randomly allocated to be screened by including every sixth man from a list of dates of birth. These men were invited to be screened every third year from 1987 to 1996. On the first two occasions screening was done by digital rectal examination only. From 1993, this was combined with prostate specific antigen testing, with 4 mu g/L as cut off. On the fourth occasion (1996), only men aged 69 or under at the time of the investigation were invited. Main outcome measures Data on tumour stage, grade, and treatment from the South East Region Prostate Cancer Register. Prostate cancer specific mortality up to 31 December 2008. Results In the four screenings from 1987 to 1996 attendance was 1161/1492 (78%), 957/1363 (70%), 895/1210 (74%), and 446/606 (74%), respectively. There were 85 cases (5.7%) of prostate cancer diagnosed in the screened group and 292 (3.9%) in the control group. The risk ratio for death from prostate cancer in the screening group was 1.16 (95% confidence interval 0.78 to 1.73). In a Cox proportional hazard analysis comparing prostate cancer specific survival in the control group with that in the screened group, the hazard ratio for death from prostate cancer was 1.23 (0.94 to 1.62; P=0.13). After adjustment for age at start of the study, the hazard ratio was 1.58 (1.06 to 2.36; P=0.024). Conclusions After 20 years of follow-up the rate of death from prostate cancer did not differ significantly between men in the screening group and those in the control group.
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| 28. |
- Santavirta, Torsten, et al.
(author)
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Long term mental health outcomes of Finnish children evacuated to Swedish families during the second world war and their non-evacuated siblings : cohort study
- 2015
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In: The BMJ. - : BMJ. - 1756-1833. ; 350, s. g7753-
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Journal article (peer-reviewed)abstract
- Objectives To compare the risks of admission to hospital for any type of psychiatric disorder and for four specific psychiatric disorders among adults who as children were evacuated to Swedish foster families during the second world war and their non-evacuated siblings, and to evaluate whether these risks differ between the sexes.Design Cohort study.Setting National child evacuation scheme in Finland during the second world war.Participants Children born in Finland between 1933 and 1944 who were later included in a 10% sample of the 1950 Finnish census ascertained in 1997 (n=45 463; women: n=22 021; men: n=23 442). Evacuees in the sample were identified from war time government records.Main outcome measure Adults admitted to hospital for psychiatric disorders recorded between 1971 and 2011 in the Finnish hospital discharge register.Methods We used Cox proportional hazards models to estimate the association between evacuation to temporary foster care in Sweden during the second world war and admission to hospital for a psychiatric disorder between ages 38 and 78 years. Fixed effects methods were employed to control for all unobserved social and genetic characteristics shared among siblings.Results Among men and women combined, the risk of admission to hospital for a psychiatric disorder did not differ between Finnish adults evacuated to Swedish foster families and their non-evacuated siblings (hazard ratio 0.89, 95% confidence interval 0.64 to 1.26). Evidence suggested a lower risk of admission for any mental disorder (0.67, 0.44 to 1.03) among evacuated men, whereas for women there was no association between evacuation and the overall risk of admission for a psychiatric disorder (1.21, 0.80 to 1.83). When admissions for individual psychiatric disorders were analyzed, evacuated girls were significantly more likely than their non-evacuated sisters to be admitted to hospital for a mood disorder as an adult (2.19, 1.10 to 4.33).Conclusions The Finnish evacuation policy was not associated with an increased overall risk of admission to hospital for a psychiatric disorder in adulthood among former evacuees. In fact, evacuation was associated with a marginally reduced risk of admission for any psychiatric disorder among men. Among women who had been evacuated, however, the risk of being admitted to hospital for a mood disorder was increased.
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| 29. |
- Ueda, Peter, et al.
(author)
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Alcohol related disorders among elite male football players in Sweden : nationwide cohort study
- 2022
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In: BMJ. British Medical Journal. - : BMJ Publishing Group Ltd. - 0959-8146 .- 0959-535X. ; 379
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To assess whether male elite football players are at increased risk of alcohol related disorders compared with men from the general population, and whether such an increased risk would vary on the basis of calendar year of the first playing season in the top tier of competition, age, career length, and goal scoring abilities.DESIGN: Nationwide cohort study.SETTING: Sweden, 1924-2020.PARTICIPANTS: 6007 male football players who had played in the Swedish top division, Allsvenskan, from 1924 to 2019 and 56 168 men from the general population matched to players based on age and region of residence.MAIN OUTCOME MEASURES: Primary outcome was alcohol related disorders (diagnoses recorded in death certificates, during hospital admissions and outpatient visits, or use of prescription drugs for alcohol addiction); secondary outcome was disorders related to misuse of other drugs.RESULTS: During follow-up up to 31 December 2020, 257 (4.3%) football players and 3528 (6.3%) men from the general population received diagnoses of alcohol related disorders. In analyses accounting for age, region of residence, and calendar time, risk of alcohol related disorders was lower among football players than among men from the general population (hazard ratio 0.71, 95% confidence interval 0.62 to 0.81). A reduced risk of alcohol related disorders was observed for football players who played their first season in the top tier in the early 1960s and later, while no significant difference versus men from the general population was seen in the risk for football players from earlier eras. The hazard ratio was lowest at around age 35 years, and then increased with age; at around age 75 years, football players had a higher risk of alcohol related disorders than men from the general population. No significant association was seen between goal scoring, number of games, and seasons played in the top tier and the risk of alcohol related disorders. Risk of disorders related to other drug misuse was significantly lower among football players than the general population (hazard ratio 0.22, 95% confidence interval 0.15 to 0.34).CONCLUSIONS: In this nationwide cohort study, male football players who had played in the Swedish top tier of competition had a significantly lower risk of alcohol related disorders than men from the general population.
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| 30. |
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| 31. |
- Örtqvist, Anne K, et al.
(author)
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Antibiotics in fetal and early life and subsequent childhood asthma : nationwide population based study with sibling analysis
- 2014
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In: BMJ. - Stockholm : Karolinska Institutet, Dept of Medical Epidemiology and Biostatistics. - 0959-535X .- 1756-1833.
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Journal article (peer-reviewed)abstract
- Erratum to this article in BMJ. 2014;349:g7395. OBJECTIVE: To investigate the association between exposure to antibiotics in fetal and early life and asthma in childhood, with adjustment for confounding factors. DESIGN: Nationwide prospective population based cohort study, including sibling control design. SETTING: Swedish population identified from national demographic and health registers. PARTICIPANTS: 493,785 children born 2006-10; 180,894 of these were eligible for sibling analyses. MAIN OUTCOME MEASURE: Asthma defined as having both an asthma diagnosis and dispensed asthma drugs. The association between antibiotic exposure and asthma was investigated in the whole cohort with Cox proportional hazard regression. A stratified proportional hazards model conditional on sibling group was used to adjust for shared factors within families. Confounding by respiratory infections was assessed by investigating whether specific groups of antibiotics were associated with asthma. RESULTS: Antibiotic exposure in fetal life was associated with an increased risk of asthma in cohort analyses (hazard ratio 1.28, 95% confidence interval 1.25 to 1.32), but not in sibling analyses (0.99, 0.92 to 1.07). In cohort analyses, antibiotics used to treat respiratory infections in childhood were associated with a more pronounced increased risk of asthma (4.12, 3.78 to 4.50) than antibiotics used for urinary tract and skin infections (1.54, 1.24 to 1.92). In sibling analyses, the excess risks after exposure to antibiotics for respiratory infections decreased (2.36, 1.78 to 3.13) and disappeared for antibiotics for urinary tract and skin (0.85, 0.47 to 1.55). CONCLUSIONS: Previous positive associations between exposure to antibiotics in fetal and early life and subsequent childhood asthma could have been caused by confounding by shared familial factors, in addition to confounding by respiratory infections.
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| 32. |
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| 33. |
- Blom, A. W., et al.
(author)
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Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial
- 2022
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In: Bmj-British Medical Journal. - : BMJ. - 0959-535X. ; 379
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Journal article (peer-reviewed)abstract
- OBJECTIVESTo determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.DESIGNPragmatic, parallel group, open label, randomised controlled trial.SETTINGHigh volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018.PARTICIPANTS 140 adults (aged a18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision).INTERVENTIONS A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure.MAIN OUTCOME MEASURES The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups.RESULTS The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval-8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of (sic)11 167 (95% confidence interval (sic)638 to (sic)21 696) at a (sic)20 000 per quality adjusted life years threshold ((sic)1.0; $1.1; (sic) 1.4).CONCLUSIONS At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery.
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| 34. |
- Boman, Magnus
(author)
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Commentary : The joy of mesh
- 2009
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 337, s. a2500-
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Journal article (peer-reviewed)
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| 35. |
- Godbolt, Alison K.
(author)
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Scandinavian solution
- 2008
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 337, s. a2586-
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Journal article (peer-reviewed)
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| 36. |
- Hartman, Esther A R, et al.
(author)
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Effect of a multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for suspected urinary tract infections in frail older adults (ImpresU): pragmatic cluster randomised controlled trial in four European countries.
- 2023
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In: BMJ (Clinical research ed.). - : BMJ. - 0959-535X .- 1756-1833. ; 380
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Journal article (peer-reviewed)abstract
- To evaluate whether antibiotic prescribing for suspected urinary tract infections in frail older adults can be reduced through a multifaceted antibiotic stewardship intervention.Pragmatic, parallel, cluster randomised controlled trial, with a five month baseline period and a seven month follow-up period.38 clusters consisting of one or more general practices (n=43) and older adult care organisations (n=43) in Poland, the Netherlands, Norway, and Sweden, from September 2019 to June 2021.1041 frail older adults aged 70 or older (Poland 325, the Netherlands 233, Norway 276, Sweden 207), contributing 411 person years to the follow-up period.Healthcare professionals received a multifaceted antibiotic stewardship intervention consisting of a decision tool for appropriate antibiotic use, supported by a toolbox with educational materials. A participatory-action-research approach was used for implementation, with sessions for education, evaluation, and local tailoring of the intervention. The control group provided care as usual.The primary outcome was the number of antibiotic prescriptions for suspected urinary tract infections per person year. Secondary outcomes included the incidence of complications, all cause hospital referrals, all cause hospital admissions, all cause mortality within 21 days after suspected urinary tract infections, and all cause mortality.The numbers of antibiotic prescriptions for suspected urinary tract infections in the follow-up period were 54 prescriptions in 202 person years (0.27 per person year) in the intervention group and 121 prescriptions in 209 person years (0.58 per person year) in the usual care group. Participants in the intervention group had a lower rate of receiving an antibiotic prescription for a suspected urinary tract infection compared with participants in the usual care group, with a rate ratio of 0.42 (95% confidence interval 0.26 to 0.68). No differences between intervention and control group were observed in the incidence of complications (<0.01 v 0.05 per person year), hospital referrals (<0.01 v 0.05), admissions to hospital (0.01 v 0.05), and mortality (0 v 0.01) within 21 days after suspected urinary tract infections, nor in all cause mortality (0.26 v 0.26).Implementation of a multifaceted antibiotic stewardship intervention safely reduced antibiotic prescribing for suspected urinary tract infections in frail older adults.ClinicalTrials.gov NCT03970356.
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| 37. |
- Hoff, Geir, et al.
(author)
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Risk of colorectal cancer seven years after flexible sigmoidoscopy screening : randomised controlled trial
- 2009
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 338, s. b1846-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To determine the risk of colorectal cancer after screening with flexible sigmoidoscopy. DESIGN: Randomised controlled trial. SETTING: Population based screening in two areas in Norway-city of Oslo and Telemark county (urban and mixed urban and rural populations). PARTICIPANTS: 55 736 men and women aged 55-64 years. INTERVENTION: Once only flexible sigmoidoscopy screening with or without a single round of faecal occult blood testing (n=13 823) compared with no screening (n=41 913). MAIN OUTCOME MEASURES: Planned end points were cumulative incidence and mortality of colorectal cancer after 5, 10, and 15 years. This first report from the study presents cumulative incidence after 7 years of follow-up and hazard ratio for mortality after 6 years. RESULTS: No difference was found in the 7 year cumulative incidence of colorectal cancer between the screening and control groups (134.5 v 131.9 cases per 100 000 person years). In intention to screen analysis, a trend towards reduced colorectal cancer mortality was found (hazard ratio 0.73, 95% confidence interval 0.47 to 1.13, P=0.16). For attenders compared with controls, a statistically significant reduction in mortality was apparent for both total colorectal cancer (hazard ratio 0.41, 0.21 to 0.82, P=0.011) and rectosigmoidal cancer (0.24, 0.08 to 0.76, P=0.016). CONCLUSIONS: A reduction in incidence of colorectal cancer with flexible sigmoidoscopy screening could not be shown after 7 years' follow-up. Mortality from colorectal cancer was not significantly reduced in the screening group but seemed to be lower for attenders, with a reduction of 59% for any location of colorectal cancer and 76% for rectosigmoidal cancer in per protocol analysis, an analysis prone to selection bias. TRIAL REGISTRATION: Clinical trials NCT00119912.
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| 38. |
- Holmgren, Theresa, et al.
(author)
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Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome : randomised controlled study
- 2012
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In: BMJ. British Medical Journal. - : BMJ Publishing Group. - 0959-8146 .- 0959-535X. ; 344, s. e787-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To evaluate if a specific exercise strategy, targeting the rotator cuff and scapula stabilisers, improves shoulder function and pain more than unspecific exercises in patients with subacromial impingement syndrome, thereby decreasing the need for arthroscopic subacromial decompression.DESIGN: Randomised, participant and single assessor blinded, controlled study.SETTING: Department of orthopaedics in a Swedish university hospital.PARTICIPANTS: 102 patients with long standing (over six months) persistent subacromial impingement syndrome in whom earlier conservative treatment had failed, recruited through orthopaedic specialists.INTERVENTIONS: The specific exercise strategy consisted of strengthening eccentric exercises for the rotator cuff and concentric/eccentric exercises for the scapula stabilisers in combination with manual mobilisation. The control exercise programme consisted of unspecific movement exercises for the neck and shoulder. Patients in both groups received five to six individual guided treatment sessions during 12 weeks. In between these supervised sessions the participants performed home exercises once or twice a day for 12 weeks.MAIN OUTCOME MEASURES: The primary outcome was the Constant-Murley shoulder assessment score evaluating shoulder function and pain. Secondary outcomes were patients' global impression of change because of treatment and decision regarding surgery.RESULTS: Most (97, 95%) participants completed the 12 week study. There was a significantly greater improvement in the Constant-Murley score in the specific exercise group than in the control exercise group (24 points (95% confidence interval 19 to 28.0) v 9 points (5 to 13); mean difference between group: 15 points (8.5 to 20.6)). Significantly more patients in the specific exercise group reported successful outcome (defined as large improvement or recovered) in the patients' global assessment of change because of treatment: 69% (35/51) v 24% (11/46); odds ratio 7.6, 3.1 to 18.9; P<0.001. A significantly lower proportion of patients in the specific exercise group subsequently chose to undergo surgery: 20% (10/51) v 63% (29/46); odds ratio 7.7, 3.1 to 19.4; P<0.001).CONCLUSION: A specific exercise strategy, focusing on strengthening eccentric exercises for the rotator cuff and concentric/eccentric exercises for the scapula stabilisers, is effective in reducing pain and improving shoulder function in patients with persistent subacromial impingement syndrome. By extension, this exercise strategy reduces the need for arthroscopic subacromial decompression within the three month timeframe used in the study.TRIAL REGISTRATION: Clinical trials NCT01037673.
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| 39. |
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| 40. |
- Jenab, Mazda, et al.
(author)
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Association between pre-diagnostic circulating vitamin D concentration and risk of colorectal cancer in European populations : a nested case-control study
- 2010
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In: BMJ. British Medical Journal. - : BMJ Publishing Group. - 0959-8146 .- 0959-535X. ; 340, s. b5500-
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To examine the association between pre-diagnostic circulating vitamin D concentration, dietary intake of vitamin D and calcium, and the risk of colorectal cancer in European populations. DESIGN: Nested case-control study. Setting The study was conducted within the EPIC study, a cohort of more than 520 000 participants from 10 western European countries. PARTICIPANTS: 1248 cases of incident colorectal cancer, which developed after enrolment into the cohort, were matched to 1248 controls MAIN OUTCOME MEASURES: Circulating vitamin D concentration (25-hydroxy-vitamin-D, 25-(OH)D) was measured by enzyme immunoassay. Dietary and lifestyle data were obtained from questionnaires. Incidence rate ratios and 95% confidence intervals for the risk of colorectal cancer by 25-(OH)D concentration and levels of dietary calcium and vitamin D intake were estimated from multivariate conditional logistic regression models, with adjustment for potential dietary and other confounders. RESULTS: 25-(OH)D concentration showed a strong inverse linear dose-response association with risk of colorectal cancer (P for trend <0.001). Compared with a pre-defined mid-level concentration of 25-(OH)D (50.0-75.0 nmol/l), lower levels were associated with higher colorectal cancer risk (<25.0 nmol/l: incidence rate ratio 1.32 (95% confidence interval 0.87 to 2.01); 25.0-49.9 nmol/l: 1.28 (1.05 to 1.56), and higher concentrations associated with lower risk (75.0-99.9 nmol/l: 0.88 (0.68 to 1.13); >or=100.0 nmol/l: 0.77 (0.56 to 1.06)). In analyses by quintile of 25-(OH)D concentration, patients in the highest quintile had a 40% lower risk of colorectal cancer than did those in the lowest quintile (P<0.001). Subgroup analyses showed a strong association for colon but not rectal cancer (P for heterogeneity=0.048). Greater dietary intake of calcium was associated with a lower colorectal cancer risk. Dietary vitamin D was not associated with disease risk. Findings did not vary by sex and were not altered by corrections for season or month of blood donation. CONCLUSIONS: The results of this large observational study indicate a strong inverse association between levels of pre-diagnostic 25-(OH)D concentration and risk of colorectal cancer in western European populations. Further randomised trials are needed to assess whether increases in circulating 25-(OH)D concentration can effectively decrease the risk of colorectal cancer.
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| 41. |
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| 42. |
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| 43. |
- Lundberg, Lisa, et al.
(author)
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Covid-19 vaccine effectiveness against post-covid-19 condition among 589722 individuals in Sweden: population based cohort study.
- 2023
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In: BMJ (Clinical research ed.). - 0959-535X .- 1756-1833. ; 383
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Journal article (peer-reviewed)abstract
- To investigate the effectiveness of primary covid-19 vaccination (first two doses and first booster dose within the recommended schedule) against post-covid-19 condition (PCC).Population based cohort study.Swedish Covid-19 Investigation for Future Insights-a Population Epidemiology Approach using Register Linkage (SCIFI-PEARL) project, a register based cohort study in Sweden.All adults (≥18 years) with covid-19 first registered between 27 December 2020 and 9 February 2022 (n=589722) in the two largest regions of Sweden. Individuals were followed from a first infection until death, emigration, vaccination, reinfection, a PCC diagnosis (ICD-10 diagnosis code U09.9), or end of follow-up (30 November 2022), whichever came first. Individuals who had received at least one dose of a covid-19 vaccine before infection were considered vaccinated.The primary outcome was a clinical diagnosis of PCC. Vaccine effectiveness against PCC was estimated using Cox regressions adjusted for age, sex, comorbidities (diabetes and cardiovascular, respiratory, and psychiatric disease), number of healthcare contacts during 2019, socioeconomic factors, and dominant virus variant at time of infection.Of 299692 vaccinated individuals with covid-19, 1201 (0.4%) had a diagnosis of PCC during follow-up, compared with 4118 (1.4%) of 290030 unvaccinated individuals. Covid-19 vaccination with any number of doses before infection was associated with a reduced risk of PCC (adjusted hazard ratio 0.42, 95% confidence interval 0.38 to 0.46), with a vaccine effectiveness of 58%. Of the vaccinated individuals, 21111 received one dose only, 205650 received two doses, and 72931 received three or more doses. Vaccine effectiveness against PCC for one dose, two doses, and three or more doses was 21%, 59%, and 73%, respectively.The results of this study suggest a strong association between covid-19 vaccination before infection and reduced risk of receiving a diagnosis of PCC. The findings highlight the importance of primary vaccination against covid-19 to reduce the population burden of PCC.
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| 44. |
- Pasternak, Bjorn, et al.
(author)
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Glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer: Scandinavian cohort study
- 2024
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In: BMJ-BRITISH MEDICAL JOURNAL. - 0959-535X .- 1756-1833. ; 385
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Journal article (peer-reviewed)abstract
- OBJECTIVE To investigate whether use of glucagon-like peptide 1 (GLP1) receptor agonists is associated with increased risk of thyroid cancer. DESIGN Scandinavian cohort study. SETTING Denmark, Norway, and Sweden, 2007-21. PARTICIPANTS Patients who started GLP1 receptor agonist treatment were compared with patients who started dipeptidyl peptidase 4 (DPP4) inhibitor treatment, and in an additional analysis, patients who started sodiumglucose cotransporter 2 (SGLT2) inhibitor treatment. MAIN OUTCOME MEASURES Thyroid cancer identified from nationwide cancer registers. An active -comparator new user study design was used to minimise risks of confounding and time related biases from using real world studies of drug effects. Cox regression was used to estimate hazard ratios, controlling for potential confounders with propensity score weighting. RESULTS The mean follow-up time was 3.9 years (standard deviation 3.5 years) in the GLP1 receptor agonist group and 5.4 years (standard deviation 3.5 years) in the DPP4 inhibitor group. 76 of 145 410 patients (incidence rate 1.33 events per 10 000 person years) treated with GLP1 receptor agonists and 184 of 291 667 patients (incidence rate 1.46 events per 10 000 person years) treated with DPP4 inhibitors developed thyroid cancer. GLP1 receptor agonist use was not associated with increased risk of thyroid cancer (hazard ratio 0.93, 95% confidence interval 0.66 to 1.31; rate difference -0.13, 95% confidence interval -0.61 to 0.36 events per 10 000 person years). The hazard ratio for medullary thyroid cancer was 1.19 (0.37 to 3.86). In the additional analysis comparing the GLP1 receptor agonist group with the SGLT2 inhibitor group, the hazard ratio for thyroid cancer was 1.16 (0.65 to 2.05). CONCLUSIONS In this large cohort study using nationwide data from three countries, GLP1 receptor agonist use was not associated with a substantially increased risk of thyroid cancer over a mean follow-up of 3.9 years. In the main analysis comparing GLP1 receptor agonists with DPP4 inhibitors, the upper limit of the confidence interval was consistent with no more than a 31% increase in relative risk.
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| 45. |
- Room, Robin
(author)
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Prohibition of cannabis
- 2010
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 341:7776
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Journal article (peer-reviewed)
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| 46. |
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| 47. |
- So, Anthony D, et al.
(author)
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Tackling antibiotic resistance
- 2010
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In: BMJ. British Medical Journal. - : BMJ. - 0959-8146 .- 0959-535X. ; 340, s. c2071-
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Journal article (other academic/artistic)
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| 48. |
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| 49. |
- Henriksson, Martin, et al.
(author)
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Assessing the cost effectiveness of using prognostic biomarkers with decision models: case study in prioritising patients waiting for coronary artery surgery
- 2010
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In: BRITISH MEDICAL JOURNAL. - : BMJ. - 0959-535X. ; 340
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Journal article (peer-reviewed)abstract
- Objective To determine the effectiveness and cost effectiveness of using information from circulating biomarkers to inform the prioritisation process of patients with stable angina awaiting coronary artery bypass graft surgery. Design Decision analytical model comparing four prioritisation strategies without biomarkers (no formal prioritisation, two urgency scores, and a risk score) and three strategies based on a risk score using biomarkers: a routinely assessed biomarker (estimated glomerular filtration rate), a novel biomarker (C reactive protein), or both. The order in which to perform coronary artery bypass grafting in a cohort of patients was determined by each prioritisation strategy, and mean lifetime costs and quality adjusted life years (QALYs) were compared. Data sources Swedish Coronary Angiography and Angioplasty Registry (9935 patients with stable angina awaiting coronary artery bypass grafting and then followed up for cardiovascular events after the procedure for 3.8 years), and meta-analyses of prognostic effects (relative risks) of biomarkers. Results The observed risk of cardiovascular events while on the waiting list for coronary artery bypass grafting was 3 per 10 000 patients per day within the first 90 days (184 events in 9935 patients). Using a cost effectiveness threshold of 20 pound 000-30 pound 000 ((sic)22 000-(sic)33 000; $32 000-$48 000) per additional QALY, a prioritisation strategy using a risk score with estimated glomerular filtration rate was the most cost effective strategy (cost per additional QALY was andlt;410 pound compared with the Ontario urgency score). The impact on population health of implementing this strategy was 800 QALYs per 100 000 patients at an additional cost of 245 pound 000 to the National Health Service. The prioritisation strategy using a risk score with C reactive protein was associated with lower QALYs and higher costs compared with a risk score using estimated glomerular filtration rate. Conclusion Evaluating the cost effectiveness of prognostic biomarkers is important even when effects at an individual level are small. Formal prioritisation of patients awaiting coronary artery bypass grafting using a routinely assessed biomarker (estimated glomerular filtration rate) along with simple, routinely collected clinical information was cost effective. Prioritisation strategies based on the prognostic information conferred by C reactive protein, which is not currently measured in this context, or a combination of C reactive protein and estimated glomerular filtration rate, is unlikely to be cost effective. The widespread practice of using only implicit or informal means of clinically ordering the waiting list may be harmful and should be replaced with formal prioritisation approaches.
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