The association of isolated tumor cells and micrometastases in regional lymph nodes with the clinical outcome of breast cancer is unclear.
We identified all patients in The Netherlands who underwent ...a sentinel-node biopsy for breast cancer before 2006 and had breast cancer with favorable primary-tumor characteristics and isolated tumor cells or micrometastases in the regional lymph nodes. Patients with node-negative disease were randomly selected from the years 2000 and 2001. The primary end point was disease-free survival.
We identified 856 patients with node-negative disease who had not received systemic adjuvant therapy (the node-negative, no-adjuvant-therapy cohort), 856 patients with isolated tumor cells or micrometastases who had not received systemic adjuvant therapy (the node-positive, no-adjuvant-therapy cohort), and 995 patients with isolated tumor cells or micrometastases who had received such treatment (the node-positive, adjuvant-therapy cohort). The median follow-up was 5.1 years. The adjusted hazard ratio for disease events among patients with isolated tumor cells who did not receive systemic therapy, as compared with women with node-negative disease, was 1.50 (95% confidence interval CI, 1.15 to 1.94); among patients with micrometastases, the adjusted hazard ratio was 1.56 (95% CI, 1.15 to 2.13). Among patients with isolated tumor cells or micrometastases, the adjusted hazard ratio was 0.57 (95% CI, 0.45 to 0.73) in the node-positive, adjuvant-therapy cohort, as compared with the node-positive, no-adjuvant-therapy cohort.
Isolated tumor cells or micrometastases in regional lymph nodes were associated with a reduced 5-year rate of disease-free survival among women with favorable early-stage breast cancer who did not receive adjuvant therapy. In patients with isolated tumor cells or micrometastases who received adjuvant therapy, disease-free survival was improved.
The incidence rate of breast cancer is increasing and has become the most common cancer in Vietnamese women while the survival rate is lower than that of developed countries. Early detection to ...improve breast cancer survival as well as reducing risk factors remains the cornerstone of breast cancer control according to the World Health Organization (WHO). This study aims to evaluate the costs and outcomes of introducing a mammography screening program for Vietnamese women aged 45-64 years, compared to the current situation of no screening.
Decision analytical modeling using Markov chain analysis was used to estimate costs and health outcomes over a lifetime horizon. Model inputs were derived from published literature and the results were reported as incremental cost-effectiveness ratios (ICERs) and/or incremental net monetary benefits (INMBs). One-way sensitivity analyses and probabilistic sensitivity analyses were performed to assess parameter uncertainty.
The ICER per life year gained of the first round of mammography screening was US$3647.06 and US$4405.44 for women aged 50-54 years and 55-59 years, respectively. In probabilistic sensitivity analyses, mammography screening in the 50-54 age group and the 55-59 age group were cost-effective in 100% of cases at a threshold of three times the Vietnamese Gross Domestic Product (GDP) i.e., US$6332.70. However, less than 50% of the cases in the 60-64 age group and 0% of the cases in the 45-49 age group were cost effective at the WHO threshold. The ICERs were sensitive to the discount rate, mammography sensitivity, and transition probability from remission to distant recurrence in stage II for all age groups.
From the healthcare payer viewpoint, offering the first round of mammography screening to Vietnamese women aged 50-59 years should be considered, with the given threshold of three times the Vietnamese GDP per capita.
In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct ...comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.
To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.
Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.
Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).
The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.
Among 393 participants included in the as-randomized analysis (mean age, 61.7 years SD, 9.1 years), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.
Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.
TrialRegister.nl Identifier: NTR 6978.
In case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately ...50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL.
A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46-219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups.
The sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management.
To evaluate age-dependent productivity loss caused by menstruation-related symptoms, measured in absenteeism (time away from work or school) and presenteeism (productivity loss while present at work ...or school).
Design/setting: internet-based, cross-sectional survey conducted in the Netherlands from July to October 2017.
32 748 women aged 15-45 years, recruited through social media.
self-reported lost productivity in days, divided into absenteeism and presenteeism; impact of menstrual symptoms; reasons women give when calling in sick; and women's preferences regarding the implications of menstruation-related symptoms for schools and workplaces.
A total of 13.8% (n=4514) of all women reported absenteeism during their menstrual periods with 3.4% (n=1108) reporting absenteeism every or almost every menstrual cycle. The mean absenteeism related to a woman's period was 1.3 days per year. A total of 80.7% (n=26 438) of the respondents reported presenteeism and decreased productivity a mean of 23.2 days per year. An average productivity loss of 33% resulted in a mean of 8.9 days of total lost productivity per year due to presenteeism. Women under 21 years were more likely to report absenteeism due to menstruation-related symptoms (OR 3.3, 95% CI 3.1 to 3.6). When women called in sick due to their periods, only 20.1% (n=908) told their employer or school that their absence was due to menstrual complaints. Notably, 67.7% (n=22 154) of the participants wished they had greater flexibility in their tasks and working hours at work or school during their periods.
Menstruation-related symptoms cause a great deal of lost productivity, and presenteeism is a bigger contributor to this than absenteeism. There is an urgent need for more focus on the impact of these symptoms, especially in women aged under 21 years, for discussions of treatment options with women of all ages and, ideally, more flexibility for women who work or go to school.
Preoperative colorectal cancer care pathways for older patients show considerable practice variation between Dutch hospitals due to differences in interpretation and implementation of guideline-based ...recommendations. This study aims to report this practice variation in preoperative care between Dutch hospitals in terms of technical efficiency and identifying associated factors.
Data on preoperative involvement of geriatricians, physical therapists and dieticians and the clinicians' judgement on prehabilitation implementation were collected using quality indicators and questionnaires among colorectal cancer surgeons and specialized nurses. These data were combined with registry-based data on postoperative outcomes obtained from the Dutch Surgical Colorectal Audit for patients aged ≥75 years. A two-stage data envelopment analysis (DEA) approach was used to calculate bias-corrected DEA technical efficiency scores, reflecting the extent to which a hospital invests in multidisciplinary preoperative care (input) in relation to postoperative outcomes (output). In the second stage, hospital care characteristics were used in a bootstrap truncated regression to explain variations in measured efficiency scores.
Data of 25 Dutch hospitals were analyzed. There was relevant practice variation in bias-corrected technical efficiency scores (ranging from 0.416 to 0.968) regarding preoperative colorectal cancer surgery. The average efficiency score of hospitals was significantly different from the efficient frontier (p = <0.001). After case-mix correction, higher technical efficiency was associated with larger practice size (p = <0.001), surgery performed in a general hospital versus a university hospital (p = <0.001) and implementation of prehabilitation (p = <0.001).
This study showed considerable variation in technical efficiency of preoperative colorectal cancer care for older patients as provided by Dutch hospitals. In addition to higher technical efficiency in high-volume hospitals and general hospitals, offering a care pathway that includes prehabilitation was positively related to technical efficiency of hospitals offering colorectal cancer care.
Abstract
BACKGROUND
Admitting patients to an intensive care or medium care unit (ICU/MCU) after adult supratentorial tumor craniotomy remains common practice even though some studies have suggested ...lower level care is sufficient for selected patients. We have introduced a “no ICU, unless” policy for tumor craniotomy patients.
OBJECTIVE
To provide a quieter postoperative environment for patients, reduce the burden on the ICU department, and to evaluate whether costs can be reduced.
METHODS
A cohort study was performed comparing patients that underwent tumor craniotomy for supratentorial tumors during 1 yr after introduction (n = 109) of the new policy with the year before (n = 107). Rate of complications was evaluated, as was the length of stay and patient satisfaction using qualitative evaluation. Finally, costs were evaluated comparing the situation before and after implementation of the new protocol.
RESULTS
A reduction in ICU/MCU admittance from 64% to 24% of patients was found resulting in 13.3% cost reduction (€1950 per case), without increasing the length of stay at the ward. The length of stay in the hospital was similar. Complications were significantly reduced after implementing the new policy (0.98 vs 0.53 per patient, P = .003). Patients that were interviewed after the new policy reported feeling safe and at ease at the ward.
CONCLUSION
Changing our policy from “ICU, unless” to “no ICU, unless” reduced complication rates and length of stay in the hospital while keeping patients satisfied. Hospital costs related to the admission have been significantly reduced by the new policy.
The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers ...carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention.
Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents' neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects.
34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects.
Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect.
Dutch Trials Registry NTR2314.
Summary Background In patients with prostate cancer who are deemed to be at intermediate or high risk of having nodal metastases, invasive diagnostic pelvic lymph-node dissection (PLND) is the gold ...standard for the detection of nodal disease. However, a new lymph-node-specific MR-contrast agent ferumoxtran-10 can detect metastases in normal-sized nodes (ie, <8 mm in size) by use of MR lymphoangiography (MRL). In this prospective, multicentre cohort study, we aimed to compare the diagnostic accuracy of MRL with up-to-date multidetector CT (MDCT), and test the hypothesis that a negative MRL finding obviates the need for a PLND. Methods We included consecutive patients with prostate cancer who had an intermediate or high risk (risk of >5% according to routinely used nomograms) of having lymph-node metastases. All patients were assessed by MDCT and MRL, and underwent PLND or fine-needle aspiration biopsy. Imaging results were correlated with histopathology. The primary outcomes were sensitivity, specificity, accuracy, NPV, and PPV of MRL and MDCT. This study is registered with ClinicalTrials.gov , number NCT00185029. Findings The study was done in 11 hospitals in the Netherlands between April 8, 2003, and April 19, 2005. 375 consecutive patients were included. 61 of 375 (16%) patients had lymph-node metastases. Sensitivity was 34% (21 of 61; 95% CI 23–48) for MDCT and 82% (50 of 61; 70–90) for MRL (McNemar's test p<0·05). Specificity was 97% (303 of 314; 94–98) for MDCT and 93% (291 of 314; 89–95) for MRL. Positive predictive value (PPV) was 66% (21 of 32; 47–81) for MDCT and 69% (50 of 73; 56–79) for MRL. Negative predictive value (NPV) was 88% (303 of 343; 84–91) for MDCT and 96% (291 of 302; 93–98) for MRL (McNemar's test p<0·05). Of the 61 patients with lymph-node metastases, 50 were detected by MRL, of which 40 (80%) had metastases in normal-sized lymph nodes. The high sensitivity and NPV of MRL imply that in patients with a negative MRL, the chance of positive lymph nodes is less than 11/302 (4%). Interpretation MRL had significantly higher sensitivity and NPV than MDCT for patients with prostate cancer who had intermediate or high risk of having lymph-node metastases. In such patients, after a negative MRL, the post-test probability of having lymph-node metastases is low enough to omit a PLND. Funding The Netherlands Organisation for Health Research and Management (ZON-MW 945-02-051; The Hague, Netherlands), and TASK24 (Nieuwegein, Netherlands).
Abstract
Aims
Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A clinical risk score with point-of-care ...(POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is unnecessary. The aim was to assess safety and healthcare costs of a pre-hospital rule-out strategy using a POC troponin measurement in low-risk suspected NSTE-ACS patients.
Methods and results
This investigator-initiated, randomized clinical trial was conducted in five ambulance regions in the Netherlands. Suspected NSTE-ACS patients with HEAR (History, ECG, Age, Risk factors) score ≤3 were randomized to pre-hospital rule-out with POC troponin measurement or direct transfer to the ED. The sample size calculation was based on the primary outcome of 30-day healthcare costs. Secondary outcome was safety, defined as 30-day major adverse cardiac events (MACE), consisting of ACS, unplanned revascularization or all-cause death. : A total of 863 participants were randomized. Healthcare costs were significantly lower in the pre-hospital strategy (€1349 ± €2051 vs. €1960 ± €1808) with a mean difference of €611 95% confidence interval (CI): 353–869; P < 0.001. In the total population, MACE were comparable between groups 3.9% (17/434) in pre-hospital strategy vs. 3.7% (16/429) in ED strategy; P = 0.89. In the ruled-out ACS population, MACE were very low 0.5% (2/419) vs. 1.0% (4/417), with a risk difference of −0.5% (95% CI −1.6%–0.7%; P = 0.41) in favour of the pre-hospital strategy.
Conclusion
Pre-hospital rule-out of ACS with a POC troponin measurement in low-risk patients significantly reduces healthcare costs while incidence of MACE was low in both strategies.
Trial registration
Clinicaltrials.gov identifier NCT05466591 and International Clinical Trials Registry Platform id NTR 7346.
Structured Graphical Abstract
Structured Graphical Abstract
ACS, acute coronary syndrome; CI, confidence interval; ED, emergency department; MACE, major adverse cardiac events; NSTE-ACS, non-ST-elevation acute coronary syndrome; POC, point-of-care
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