Eline Aas

Effect of Flexible Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality A Randomized Clinical Trial

IMPORTANCE Colorectal cancer is a major health burden. Screening is recommended in many countries. OBJECTIVE To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry. INTERVENTIONS Participants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention. MAIN OUTCOMES AND MEASURES Colorectal cancer incidence and mortality. RESULTS A total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups. CONCLUSIONS AND RELEVANCE In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00119912.

Why do some pregnant women prefer cesarean? The influence of parity, delivery experiences, and fear

OBJECTIVE We sought to identify predictors of preferences for cesarean among pregnant women, and estimate how different predictors influence preferences. STUDY DESIGN This was a cross-sectional study based on the Norwegian Mother and Child Cohort Study (n = 58,881). RESULTS Of the study population, 6% preferred cesarean over vaginal delivery. While 2.4% of nulliparous had a strong preference for cesarean, the proportion among multiparous was 5.1%. The probability that a woman, absent potential predictors, would have a cesarean preference was similar (<2%) for both nulliparous or multiparous. In the presence of concurrent predictors such as previous cesarean, negative delivery experience, and fear of birth, the predicted probability of a cesarean request ranged from 20-75%. CONCLUSION The proportion of women with a strong preference for cesarean was higher among multiparous than nulliparous women, but the difference was attributable to factors such as previous cesarean or fear of delivery and not to parity per se.

Cost-effectiveness in fall prevention for older women

Aims: The aim of this study was to estimate the cost-effectiveness of implementing an exercise-based fall prevention programme for home-dwelling women in the !80-year age group in Norway. Methods: The impact of the home-based individual exercise programme on the number of falls is based on a New Zealand study. On the basis of the cost estimates and the estimated reduction in the number of falls obtained with the chosen programme, we calculated the incremental costs and the incremental effect of the exercise programme as compared with no prevention. The calculation of the average healthcare cost of falling was based on assumptions regarding the distribution of fall injuries reported in the literature, four constructed representative case histories, assumptions regarding healthcare provision associated with the treatment of the specified cases, and estimated unit costs from Norwegian cost data. We calculated the average healthcare costs per fall for the first year. Results: We found that the reduction in healthcare costs per individual for treating fall-related injuries was 1.85 times higher than the cost of implementing a fall prevention programme. Conclusions: The reduction in healthcare costs more than offset the cost of the prevention programme for women aged !80 years living at home, which indicates that health authorities should increase their focus on prevention. The main intention of this article is to stipulate costs connected to falls among the elderly in a transparent way and visualize the whole cost picture. Cost-effectiveness analysis is a health policy tool that makes politicians and other makers of health policy conscious of this complexity.

The cost of hemiarthroplasty compared to that of internal fixation for femoral neck fractures. 2-year results involving 222 patients based on a randomized controlled trial.

Background and purpose There is very little information on the cost of different treatments for femoral neck fractures. We assessed whether total hospital and societal costs of treatment of elderly patients with displaced femoral neck fractures differ between patients operated with internal fixation or hemiarthroplasty. Methods 222 patients (mean age 83 years, 165 women (74%)) who had been randomized to internal fixation or hemiarthroplasty were followed for 2 years. Resource use in hospital, rehabilitation, community-based care, and nursing home use were identified, quantified, evaluated, and analyzed. Results The average cost per patient for the initial hospital stay was lower for patients in the internal fixation group than in the hemiarthroplasty group (€9,044 vs. €11,887, p < 0.01). When all hospital costs, i.e. rehabilitation, reoperations, and formal and informal contact with the hospital were included, the costs were similar (€21,709 for internal fixation vs. €19,976 for hemiarthroplasty). When all costs were included (hospital admissions, cost of nursing home, and community-based care), internal fixation was the most expensive treatment (€47,186 vs. €38,615 (p = 0.09)). Interpretation The initial lower average cost per patient for internal fixation as treatment for a femoral neck fracture cannot be used as an argument in favor of this treatment, since the average cost per patient is more than outweighed by subsequent costs, mainly due to a higher reoperation rate after internal fixation.

Laparoscopic Versus Open Resection for Colorectal Liver Metastases: The OSLO-COMET Randomized Controlled Trial.

Objective: To perform the first randomized controlled trial to compare laparoscopic and open liver resection. Summary Background Data: Laparoscopic liver resection is increasingly used for the surgical treatment of liver tumors. However, high-level evidence to conclude that laparoscopic liver resection is superior to open liver resection is lacking. Methods: Explanatory, assessor-blinded, single center, randomized superiority trial recruiting patients from Oslo University Hospital, Oslo, Norway from February 2012 to January 2016. A total of 280 patients with resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic (n = 133) or open (n = 147) parenchyma-sparing liver resection. The primary outcome was postoperative complications within 30 days (Accordion grade 2 or higher). Secondary outcomes included cost-effectiveness, postoperative hospital stay, blood loss, operation time, and resection margins. Results: The postoperative complication rate was 19% in the laparoscopic-surgery group and 31% in the open-surgery group (12 percentage points difference [95% confidence interval 1.67–21.8; P = 0.021]). The postoperative hospital stay was shorter for laparoscopic surgery (53 vs 96 hours, P < 0.001), whereas there were no differences in blood loss, operation time, and resection margins. Mortality at 90 days did not differ significantly from the laparoscopic group (0 patients) to the open group (1 patient). In a 4-month perspective, the costs were equal, whereas patients in the laparoscopic-surgery group gained 0.011 quality-adjusted life years compared to patients in the open-surgery group (P = 0.001). Conclusions: In patients undergoing parenchyma-sparing liver resection for colorectal metastases, laparoscopic surgery was associated with significantly less postoperative complications compared to open surgery. Laparoscopic resection was cost-effective compared to open resection with a 67% probability. The rate of free resection margins was the same in both groups. Our results support the continued implementation of laparoscopic liver resection.

Economic evaluation of birth care in low-risk women. A comparison between a midwife-led birth unit and a standard obstetric unit within the same hospital in Norway. A randomised controlled trial.

OBJECTIVE to investigate the cost-effectiveness in birth care for low-risk women, in an alongside midwife-led unit (MU) compared to a standard obstetric unit (SCU) within the same hospital. DESIGN economic evaluation based on the findings of a randomised trial, randomising participants either into the MU or SCU. The hospitals activity-based costing system CPP was used to estimate costs, as no data on complete resource use exists. SETTING the Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Norway. PARTICIPANTS the study population consists of 1,110 consenting healthy women, assessed to be at low-risk at spontaneous onset of labour. MEASUREMENTS effect measures; avoided caesarean sections, instrumental vaginal deliveries, complications requiring treatment in the operating room, epidural analgesia and oxytocin augmentation. Costs (€) were calculated by costs per day multiplied with length of stay, added costs for procedures performed outside the units. The results are expressed in incremental cost-effectiveness ratios (ICER) with SCU as comparator. FINDINGS total costs per stay were significantly lower for women at the MU (€1,672) compared to the SCU (€1,950, p<0.001). The ICER showed that MU was a dominant strategy (lower costs and reduction in clinical procedures) for all effect measures. Based on the sensitivity analysis, allocating low-risk women to MU significantly reduced costs, but was not a dominant strategy for all outcomes. KEY CONCLUSIONS the MU is more cost-effective than the SCU for low-risk women without prelabour preference for level of birth care provided equal capacity at the units. IMPLICATIONS FOR PRACTICE it is cost-effective to organise birth care for low-risk women in a separate midwife-led unit.

Limited evidence of the effects of patient education and self-management interventions in psoriasis patients: a systematic review.

OBJECTIVE To describe the contents of educational and self-management programmes for patients with psoriasis, and to evaluate their effects. METHODS A systematic review of randomized controlled trials (RCTs), quasi-randomized trials and controlled clinical trials identified by a systematic literature search. Risk of bias was assessed by two independent reviewers and interventional effects were summarized descriptively and by meta-analysis. RESULTS Nine studies were included, which ranged from single brief interventions to long complex multidisciplinary programmes. Four RCTs with adequate sequence allocation were included to analyze interventional effects. One RCT compared two different educational programmes and found no differences between groups. The results of three trials that focused on combinations of education and self-management were heterogeneous. One RCT based on a 12-week comprehensive programme reported statistically significant effects (p<0.05) on disease severity and health-related quality of life. Two RCTs with less comprehensive programmes reported no effects on HRQoL. CONCLUSION This review showed that little evidence is available to support the effects of educational and self-management interventions in patients with psoriasis that are studied in RCTs. There is a significant lack of focused self-management and, compared with other chronic conditions, there appear to be few effective disease-specific tailored educational programmes for psoriasis.

Maternal preference for cesarean delivery: do women get what they want?

OBJECTIVE: To estimate the association between delivery preferences during pregnancy and actual delivery mode. METHODS: This was a prospective cohort study using data from the Norwegian Mother and Child Cohort Study (N=65,959). We analyzed predictors of birth outcome by means of womens preferences for mode or delivery and a range of medical and socioeconomic factors with multivariable logistic regression models. The term “elective” cesarean delivery includes cesarean deliveries planned 8 hours or more before delivery and performed as planned. RESULTS: When asked about delivery preference at 30 weeks of gestation, 5% of the women reported a preference for a cesarean delivery, 84% had a preference for vaginal delivery, and 11% were neutral. Among those with a cesarean delivery preference, 48% subsequently had a cesarean delivery (12% acute and 36% elective), and of those with a vaginal preference 12% delivered by cesarean (8.7% acute and 3.1% elective). When adjusting for maternal characteristics and medical indications, the odds for an acute cesarean delivery among nulliparous women with a cesarean delivery preference was almost two times higher (odds ratio [OR] 1.97, 95% confidence interval [CI] 1.49–2.62) and for elective cesarean delivery the preference was 12 times higher (OR 12.61, 95% CI 9.69–16.42) than for women with a vaginal preference. For multiparous women, the corresponding figures were OR 3.13 (95% CI 1.39–7.05) and OR 10.04 (95% CI 4.59–21.99). When multiparous women with previous cesarean deliveries were excluded, the OR for an elective cesarean delivery was 26 times higher given a cesarean delivery preference compared with a vaginal delivery preference (OR 25.78, 95% CI 7.89–84.28). Based on a small subset of women with planned cesarean delivery on maternal request (n=560), we estimated a predicted probability of 16% for nulliparous women (25% for multiparous women) for such cesarean delivery. CONCLUSION: Pregnant womens expressed preferences for delivery mode were associated with both elective and acute cesarean deliveries. LEVEL OF EVIDENCE: II

Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial.

Study Design. Randomized clinical trial with 2-year follow-up. Objective. To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis. Summary of Background Data. Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment. Methods. We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio. Results. The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886–3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: −0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700. Conclusion. The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate. Level of Evidence: 2

Cost-Effectiveness Analysis of an Early-Initiated, Continuous Chain of Rehabilitation after Severe Traumatic Brain Injury

The aim of this study is to estimate the long-term cost-effectiveness of two different rehabilitation trajectories after severe traumatic brain injury (sTBI). A decision tree model compared hospitalization costs, health effects, and incremental cost-effectiveness ratios (ICER) of a continuous chain versus a broken chain of rehabilitation. The expected costs were estimated by the reimbursement system using diagnosis-related group and based on point estimates of the Disability Rating Scale (DRS); the health effects were measured by means of area under the curve (AUC). The incremental health benefit was estimated as the difference in the AUCs between the chains. Lower values on the DRS scale indicate better health; thus, smaller AUCs were preferred. The modeled population was a cohort of 59 patients with sTBI (30 in continuous chain; 29 in broken chain) with 6-weeks, 1-year, and 5-year post-injury follow-ups. Regarding the DRS estimates, 5-year AUCs were 19.40 (continuous chain) and 23.46 (broken chain). Across 5 years, the continuous chain of rehabilitation had lower costs and better health effects. By replacing the broken chain with the continuous chain, NOK 37.000 could be saved and 4.06 DRS points gained. By means of probabilistic sensitivity analysis, the majority of ICER estimates (67% of the Monte Carlo simulations) indicated that a continuous chain of rehabilitation was less costly and more effective. These findings indicate that the trajectory of continuous rehabilitation represents a dominant strategy in that it reduces costs and improves outcomes after sTBI under reasonable assumptions.