The impact of the Trauma Triage App on pre-hospital trauma triage: design and protocol of the stepped-wedge, cluster-randomized TESLA trial.

BACKGROUND: Field triage of trauma patients is crucial to get the right patient to the right hospital within a particular time frame. Minimization of undertriage, overtriage, and interhospital transfer rates could substantially reduce mortality rates, life-long disabilities, and costs. Identification of patients in need of specialized trauma care is predominantly based on the judgment of Emergency Medical Services professionals and a pre-hospital triage protocol. The Trauma Triage App is a smartphone application that includes a prediction model to aid Emergency Medical Services professionals in the identification of patients in need of specialized trauma care. The aim of this trial is to assess the impact of this new digital approach to field triage on the primary endpoint undertriage. METHODS: The Trauma triage using Supervised Learning Algorithms (TESLA) trial is a stepped-wedge cluster-randomized controlled trial with eight clusters defined as Emergency Medical Services regions. These clusters are an integral part of five inclusive trauma regions. Injured patients, evaluated on-scene by an Emergency Medical Services professional, suspected of moderate to severe injuries, will be assessed for eligibility. This unidirectional crossover trial will start with a baseline period in which the default pre-hospital triage protocol is used, after which all clusters gradually implement the Trauma Triage App as an add-on to the existing triage protocol. The primary endpoint is undertriage on patient and cluster level and is defined as the transportation of a severely injured patient (Injury Severity Score ≥ 16) to a lower-level trauma center. Secondary endpoints include overtriage, hospital resource use, and a cost-utility analysis. DISCUSSION: The TESLA trial will assess the impact of the Trauma Triage App in clinical practice. This novel approach to field triage will give new and previously undiscovered insights into several isolated components of the diagnostic strategy to get the right trauma patient to the right hospital. The stepped-wedge design allows for within and between cluster comparisons. TRIAL REGISTRATION: Netherlands Trial Register, NTR7243. Registered 30 May 2018, https://www.trialregister.nl/trial/7038.

Trends in incidence of oesophageal and stomach cancer subtypes in Europe.

OBJECTIVE: Time trend studies in the USA have shown that the incidences of adenocarcinomas of the oesophagus and gastric cardia have risen strongly since the 1970s, whereas the incidence of squamous cell carcinomas of the oesophagus has declined. Earlier, we found that the incidence of these adenocarcinomas also rose in some European countries until the early 1990s. The main goal of this study was to investigate more recent trends in the incidence of oesophageal and stomach cancer subtypes in the European countries. METHODS: Eurocim cancer incidence data of 23 cancer registries from 13 European countries were used to investigate the incidence trends in oesophageal and stomach cancer subtypes during the 1983-1997 period. We calculated estimated annual percentage changes (EAPCs) in European age-standardized incidence rates and 95% confidence intervals. RESULTS: The incidence of adenocarcinomas of the oesophagus and gastric cardia rose in most, but not all, registration areas (EAPCs were usually 1-7%), the strongest in the UK and Ireland. Oesophageal squamous cell carcinoma incidence rose mostly in Northern European and Slovakian men (EAPCs: 1-5%) and in women from all regions (EAPCs: 1-8%), but declined mostly in Southern and Western European men (EAPCs: -1 to -5%). CONCLUSION: Our results are partly in line with earlier findings on adenocarcinomas of the oesophagus and gastric cardia. There was, however, substantial heterogeneity in trends of subtypes of these cancers within Europe. There may be different risk factors for these cancers, and the prevalence of these risk factors may differ among countries.

Trends in incidence of and mortality from uterine and ovarian cancer in Mid and South Limburg, The Netherlands, 1986-2003.

The prevalence of risk factors for endometrial and ovarian cancer, such as obesity, oral contraceptive use and parity has changed among Dutch women. Therefore, trends in age-specific incidence and mortality from endometrial and ovarian cancer were studied between 1986 and 2003 in the region of the Maastricht Cancer Registry. Trends were standardized to the European population and were examined by the estimated annual percentage change (EAPC). The overall incidence and mortality from endometrial cancer increased in the period 1993-2003 by 3.4% (P=0.03) and 4.0% (P=0.04), respectively. The increasing incidence trend was observed in stages II and III tumours. Overall incidence trends of ovarian cancer declined after 1992 by 2.6% (P=0.03) and overall mortality after 1991 by 1.7% (P=0.04). The increasing prevalence of obesity might explain the increasing trends in endometrial cancer. Parity and increased oral contraceptive use could possibly explain the decline in ovarian cancer.

Implementation of sentinel node biopsy in breast cancer patients in the Netherlands.

BACKGROUND: This population-based study describes the implementation of the sentinel node biopsy (SNB) in breast cancer patients in the Netherlands. We examined the extent of use over time of SNB in women who were considered eligible for SNB on the basis of their clinical status. METHODS: The study included a total of 35,465 breast cancer patients who were diagnosed with T1-2 tumours (5.0 cm), negative axillary lymph node status and no distant metastases upon clinical examination between 1st January 1998 and 31st December 2003 in six Comprehensive Cancer Centre regions in the Netherlands. Information on axillary surgery was classified as SNB alone, SNB+axillary lymph node dissection (ALND), ALND alone or none. Patterns of use of axillary surgery were summarised as the proportion of patients receiving each surgery type. RESULTS: Overall, 25.7% of patients underwent SNB alone, 19.1% underwent SNB+ALND, 50.0% had ALND alone and 5.2% did not have axillary surgery. SNB was more common in women who had breast-conserving surgery: 50.5% of patients who received breast-conserving surgery underwent SNB compared to 40.7% of patients who had mastectomy (p<0.0001). Amongst patients receiving breast-conserving treatment, 31.7% had SNB as final axillary surgery, whilst 20.5% of patients who had mastectomy had SNB alone (p<0.0001). The proportion of women who underwent a SNB alone or in combination with ALND increased over the period 1998-2003, from 2.1% to 45.8% and from 6.7% to 24.8%, respectively. There were marked differences in the patterns of dissemination of the use of SNB between regions: by 2003, the difference between the regions with the highest and lowest proportion of use was 25%. CONCLUSIONS: SNB has become the standard-of-care for the treatment of breast cancer patients clinically diagnosed with T1-2 tumours, clinically negative lymph nodes and without distant metastases. In 2003, 70.6% of patients with early breast cancer in the Netherlands received SNB, and within this group, 64.9% of patients had SNB as the final axillary treatment. Implementation of SNB may depend on factors associated with regional organisation of care.

A pathology-based substrate for target definition in radiosurgery of brain metastases.

PURPOSE: To investigate the need of a margin other than for accuracy reasons in stereotactic radiosurgery (SRS) of brain metastases by means of histopathology. METHODS AND MATERIALS: Evaluation of 45 patients from two pathology departments having had brain metastases and an autopsy of the brain. Growth patterns were reviewed with a focus on infiltration beyond the metastases boundary and made visible with immunohistochemical staining: the metastasis itself with tumor-specific markers, surrounding normal brain tissue with a glial marker, and a possible capsule with a soft tissue marker. Measurements were corrected by a tissue-shrinkage correction factor taken from literature. Outcomes parameters for infiltration were mean and maximum depths of infiltration and number of measured infiltration sites. RESULTS: In 48 of 76 metastases, an infiltration was present. The largest group of metastases was lung cancer. Small-cell lung cancer (SCLC) and melanoma showed a maximum depth of infiltration of > or =1 mm, and other histologies <1 mm. For non-small-cell lung cancer (NSCLC), melanoma, and sarcoma, the highest number of infiltrative sites were observed (median, 2; range, 1-8). SCLC showed significantly larger infiltrative growth, compared with other diagnostic groups. In NSCLC, the highest percentage of infiltration was present (70%). CONCLUSIONS: Infiltrative growth beyond the border of the brain metastasis was demonstrated in 63% of the cases evaluated. Infiltrative growth, therefore, has an impact in defining the clinical target volume for SRS of brain metastases, and a margin of approximately 1 mm should be added to the visible lesion.

Physical activity and risk of ovarian cancer: results from the Netherlands Cohort Study (The Netherlands).

OBJECTIVE: To investigate the association between nonoccupational physical activity and the risk of ovarian cancer among post-menopausal women. METHODS: The Netherlands Cohort Study on Diet and Cancer consists of 62,573 women aged 55-69 years at baseline. Information regarding baseline nonoccupational physical activity and history of sports activity was collected with a self-administered questionnaire in 1986. After 11.3 years of follow-up, 252 cases of invasive epithelial ovarian cancer were available for case-cohort analysis. RESULTS: In multivariate analysis and compared to women who spent less than 30 min per day on physical activity, the rate ratios (RRs) of ovarian cancer for women who spent up to 60, 90 and >90 min per day were 0.78, 0.86 and 0.72, respectively (95% confidence interval (CI) for the top category, 0.48-1.06; p-trend, 0.15). Women who spent more than 2 h per week on recreational biking and walking had a reduced risk of ovarian cancer (RR = 0.65; 95% CI: 0.41-1.01) compared to women who never participated in recreational biking or walking. CONCLUSIONS: These data suggest a modest inverse association between moderate physical activity and ovarian cancer risk. Vigorous physical activity was not associated with ovarian cancer risk.

Physical activity and the risk of prostate cancer in the Netherlands cohort study, results after 9.3 years of follow-up.

BACKGROUND: The aim of the current study was to evaluate the relation between physical activity and prostate cancer risk with specific emphasis on interaction with body mass index (BMI) and baseline energy intake. METHODS: The association between prostate cancer and physical activity was evaluated in the Netherlands Cohort Study, conducted among 58,279 men ages 55 to 69 years at entry. Information regarding baseline nonoccupational physical activity, history of sports participation, and occupational physical activity was collected with a questionnaire in 1986. After 9.3 years, 1,386 incident prostate cancer cases were available for case-cohort analyses. Multivariate incidence rate ratios (RR) and corresponding 95% confidence intervals (95% CI) were calculated using Cox regression analyses. RESULTS: Neither baseline nonoccupational physical activity (RR, 1.01; 95% CI, 0.81-1.25 for >90 versus <30 minutes per day), history of sports participation (RR, 1.04; 95% CI, 0.90-1.22 for ever versus never participated), nor occupational physical activity (RR, 0.91; 95% CI, 0.70-1.18 for >12 versus <8 KJ/min energy expenditure in the longest held job) showed an inverse relation with prostate cancer risk. We found an increased risk of prostate cancer for men who were physically active for >1 hour per day in obese men (BMI > 30) and men with a high baseline energy intake. DISCUSSION: The results of this current study do not support the hypothesis that physical activity protects against prostate cancer in men.

Energy restriction and the risk of spontaneous mammary tumors in mice: a meta-analysis.

Our meta-analysis was aimed at providing a systematic review of the literature regarding the effect of energy restriction on spontaneous mammary tumors in mice and at providing a more precise pooled (summary) estimate of the risk of mammary tumors. A sensitivity analysis was conducted to obtain insight in potential heterogeneity between the animal studies. A literature search was conducted with the following terms to identify relevant articles: animal studies, mammary tumors, fat restricted, dietary carbohydrates, energy restriction and calorie restriction. A criteria list for the assessment of quality items (i.e., study characteristics) in animal experiments was developed that was intended to quantitatively assess potential factors that underlie heterogeneous results of different animal experiments. Incidence figures were used to calculate the risk difference. The pooled risk difference was calculated by random effects meta regression analysis. Fourteen animal experiments were included in this meta-analysis. Publication bias could not be identified. The pooled risk difference for the 14 studies was -0.55 with a narrow 95% confidence interval (-0.69; -0.41), implying that the energy-restricted animal groups developed 55% less mammary tumors than the control groups. No heterogeneity could be detected between the studies based on study characteristics that included the age of mice at the start of intervention, duration of intervention, allocation of the mice, use of ad libitum control group, fertility of the mice and the type of energy-providing nutrient (fat, carbohydrate or protein). This meta-analysis confirms that energy restriction in itself consistently protects against the development of mammary tumor in mice, irrespective of the type of restricted nutrient or other study characteristics.

Energy restriction early in life and colon carcinoma risk: results of The Netherlands Cohort Study after 7.3 years of follow-up.

BACKGROUND: This study evaluated the effects of severe undernutrition during adolescence and subsequent colon carcinoma risk. METHODS: The authors evaluated The Netherlands Cohort Study on Diet and Cancer (NLCS) among 62,573 women and 58,279 men aged 55-69 years at baseline. Information on diet and risk factors was collected by questionnaire in 1986. Additional information was collected concerning residence during the hunger winter (1944-1945), the World War II years (1940-1944), and father's employment status during the economic depression of 1932-1940, which were used as indicators of exposure. After 7.3 years of follow-up, 807 colon carcinoma cases (388 females and 419 males) were available for analysis. RESULTS: Multivariate analysis showed that both men and women who had lived in a western city in 1944-1945 had a decreased colon carcinoma risk (men: relative risk [RR] = 0.85, 95% confidence interval [CI] = 0.62-1.16; women: RR = 0.80, 95% CI = 0.59-1.09). No association between colon carcinoma risk and urban versus rural residence was found during the war years (1940-1944). Having an unemployed father during the economic depression (1932-1940) was also associated with a small decrease in colon carcinoma risk for men (RR = 0.90, 95% CI =0.62-1.31) and women (RR = 0.75, 95% CI 0.49-1.14). In subgroup analyses, a decreased colon carcinoma risk for men and women who were in their adolescent growth spurt and living in a western city during the hunger winter of 1944-1945 was noted (men: RR = 0.72, 95% CI = 0.31-1.65; women: RR = 0.88, 95% CI = 0.40-1.96). No associations were statistically significant because of the limited study size. CONCLUSIONS: In the current study, a weak inverse relation was found between energy restriction early in life and subsequent colon carcinoma risk for men and women. However, these findings need replication in a larger study.