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Harry J de Koning

Publications and source records attributed to Harry J de Koning.

At least 19 recordsLinked to original sources

Risk-based selection from the general population in a screening trial: selection criteria, recruitment and power for the Dutch-Belgian randomised lung cancer multi-slice CT screening trial (NELSON).

A method to obtain the optimal selection criteria, taking into account available resources and capacity and the impact on power, is presented for the Dutch-Belgian randomised lung cancer screening trial (NELSON). NELSON investigates whether 16-detector multi-slice computed tomography screening will decrease lung cancer mortality compared to no screening. A questionnaire was sent to 335,441 (mainly) men, aged 50-75. Smoking exposure (years smoked, cigarettes/day, years quit) was determined, and expected lung cancer mortality was estimated for different selection scenarios for the 106,931 respondents, using lung cancer mortality data by level of smoking exposure (US Cancer Prevention Study I and II). Selection criteria were chosen so that the required response among eligible subjects to reach sufficient sample size was minimised and the required sample size was within our capacity. Inviting current and former smokers (quit 15 cigarettes/day during >25 years or >10 cigarettes/day during >30 years was most optimal. With a power of 80%, 17,300-27,900 participants are needed to show a 20-25% lung cancer mortality reduction 10 years after randomisation. Until October 18, 2005 11,103 (first recruitment round) and 4,325 (second recruitment round) (total = 15,428) participants have been randomised. Selecting participants for lung cancer screening trials based on risk estimates is feasible and helpful to minimize sample size and costs. When pooling with Danish trial data (n = +/-4,000) NELSON is the only trial without screening in controls that is expected to have 80% power to show a lung cancer mortality reduction of at least 25% 10 years after randomisation.

Aged↗

A decade of breast cancer screening in The Netherlands: trends in the preoperative diagnosis of breast cancer.

PURPOSE: In a prospective, multi-institutional follow-up study we describe the trends in the preoperative pathologic confirmation of breast cancer of women who underwent breast cancer screening between 1995 and 2005. METHODS: We included all women aged 50-75 years who underwent biennial screening mammography in the southern breast cancer screening region of the Netherlands between February 13, 1995 and December 22, 2004. Clinical data, breast imaging reports, biopsy results and breast surgery reports were collected of all women with a positive screening result. Follow-up lasted through the next biennial screening examination and was approximately two years for all referred women. RESULTS: Of 258,900 mammographic screening examinations, 3,064 (1.2%) were positive screens. The majority of women (92%) were analyzed in four regional hospitals and workup yielded breast cancer in 1,332 women. From 1995 to 2005, the percentage of breast cancer cases that underwent percutaneous biopsy prior to surgery, increased from 42.4 to 100%. The proportion of cancers with a preoperative diagnosis of malignancy by percutaneous biopsy, increased from 27.1% in 1995 to 92.7% in 2004. Preoperative breast cancer confirmation by fine needle aspiration cytology (FNAC) gradually decreased from 91.3% to 14.5%, whereas preoperative confirmation by ultrasound guided core biopsy (USCB) or stereotactic core needle biopsy (SCNB) increased from 8.7% to 69.1% and from 0 to 17.4% respectively. CONCLUSIONS: A preoperative diagnosis of breast cancer is currently obtained in more than 90% of breast cancer patients. The increase in preoperative breast cancer diagnosis through 1995-2004 is correlated with the introduction of SNCB and increased use of USCB at the expense of FNAC.

Aged↗

Gleason score, age and screening: modeling dedifferentiation in prostate cancer.

Tumor differentiation as measured by the Gleason score is highly predictive of the course of prostatic cancer after diagnosis. Since the introduction of the prostate-specific antigen (PSA) test tumors are diagnosed with a favorable tumor stage and differentiation grade. Does screening with PSA just detect more tumors with favorable characteristics or is dedifferentiation actually being prevented by early detection and consequent treatment? The latter option implies that tumors dedifferentiate in the preclinical screen-detectable phase. To model the natural history of prostate cancer, we analyzed the age-specific distribution of clinical stage and Gleason score of 2,204 tumors diagnosed in the ERSPC-Rotterdam trial. We fitted 2 MISCAN simulation models to the observed data: Model I where tumors dedifferentiate before becoming screen-detectable and Model II where dedifferentiation occurs during the screen-detectable preclinical phase. The hypothesis of dedifferentiation during the screen-detectable phase was tested by a goodness of fit test of both models. In ERSPC-Rotterdam, we observed a significantly more favorable distribution of Gleason scores in screen-detected cancers compared to cancers found in the control arm, and in cancers detected in the second round compared to cancers detected in the first round of screening. Also, a significant association between Gleason score and age at diagnosis was found, most notably in cancers detected in the first round of screening. These findings were reproduced by Model II and less so by Model I, with a significant difference in goodness of fit between the 2 models (p < 0.001). This study provides epidemiological evidence of dedifferentiation as a major mechanism of progression in prostate cancer. Tumors dedifferentiate during the screen-detectable phase and consequently screening with PSA and early treatment can possibly prevent dedifferentiation.

Age Distribution↗

Risk of cardiovascular mortality in prostate cancer patients in the Rotterdam randomized screening trial.

PURPOSE: To estimate the risk of cardiovascular disease (CVD) mortality in prostate cancer patients in the Rotterdam section of European Randomized Study of Screening for Prostate Cancer, in both arms, and to compare this with the risk in the general population. METHODS: Standardized mortality ratios (SMRs) of cardiovascular mortality for 2,211 prostate cancer patients were calculated including analyses for treatment subgroups (surgery, radiotherapy, watchful waiting, and hormone therapy). Cardiovascular mortality was defined as death as a result of all CVD and as a result of coronary heart disease, acute myocardial infarction, other diseases of the heart, and cerebrovascular accidents. The prevalence of self-reported comorbidities at entry of the trial was evaluated as well. RESULTS: After a mean follow-up of 5.5 years, 258 prostate cancer patients (12%) had died. The SMR of all-cause mortality was 0.90 (95% CI, 0.79 to 1.01). The risk for cardiovascular mortality was low compared with that in the general population; the SMRs varied between 0.37 and 0.49. Low cardiovascular mortality risks were also seen within each treatment subgroup. CVD was the most frequently self-reported comorbidity at entry and prostate cancer patients undergoing radical prostatectomy reported the lowest rates (24%) compared with those receiving other therapies (40% to 42%). CONCLUSION: Although some self-selection has occurred, prostate cancer treatment did not increase the risk of dying as a result of cardiovascular causes in our cohort. The risk was significantly lower for all primary treatment modalities, suggesting that less emphasis should be put on CVD as a contraindication for aggressive (surgical) treatment for prostate cancer patients.

Aged↗

Overall and disease-specific survival of patients with screen-detected prostate cancer in the European randomized study of screening for prostate cancer, section Rotterdam.

INTRODUCTION: This report describes survival data of participants of the European Randomized Study of Screening for Prostate Cancer (ERSPC), section Rotterdam, diagnosed with prostate cancer (pCA) during the first round of screening, the prevalence screen. PATIENTS AND METHODS: pCA characteristics from cases diagnosed during the first screening round from December 1993 to March 2000 are shown. During follow-up, data were collected by semiannual patient chart review for the first 5 yr and annually thereafter. The causes of death are scored according to the diagnosis of the treating physician and are not based on the review of the independent causes-of-death committee. Overall and disease-specific survival graphs are shown in Kaplan-Maier projections and compared with expected survival outcomes for males in the same age categories from the Dutch provinces of North Holland and Flevoland. Statistical evaluation was based on Cox regression analysis. RESULTS: During the prevalence screening, 1014 patients were diagnosed with pCA. Median follow up was 55 mo, 126 (12.4%) patients died, 20 (2.0%) of pCA. Overall 5-yr observed and expected disease-specific survival was 97.7% and 82%, respectively. In the multivariate analysis, a Gleason sum of 4+4 or higher (p=0.025) was predictive of pCA death. CONCLUSIONS: The observed survival data are in line with the literature and the expected favorable outcome for a screened population. The proportion of men dying from pCA is still small, and a 10-yr follow-up period for the final evaluation of the ERSPC may be too short.

Aged↗

Factors affecting sensitivity and specificity of screening mammography and MRI in women with an inherited risk for breast cancer.

BACKGROUND: The MRISC study is a screening study, in which women with an increased risk of hereditary breast cancer are screened by a yearly mammography and MRI, and half-yearly clinical breast examination. The sensitivity found in this study was 40% for mammography and 71% for MRI and the specificity was 95 and 90%, respectively. In the current subsequent study we investigated whether these results are influenced by age, a BRCA1/2 mutation, menopausal status and breast density. PATIENTS AND METHODS: From November 1999 to October 2003, 1909 eligible women were screened and 50 breast cancers were detected. For the current analysis, data of 4134 screening rounds and 45 detected breast cancers were used. For both imaging modalities, screening parameters, receiver operating characteristic (ROC) curves and uni- and multivariate odds ratios (ORs) were calculated. All analyses were separately performed for age at entry (< 40, 40-49, > or =50), mutation status, menopausal status and breast density. RESULTS: Sensitivity of MRI was decreased in women with high breast density (adjusted OR 0.08). False-positive rates of both mammography (OR(adj) 1.67) and MRI (OR(adj) 1.21) were increased by high breast density, that of MRI by pre-menopausal status (OR(adj) 1.70), young age (OR(adj) 1.58 for women 40-49 years versus women > or =50 years) and decreased in BRCA1/2 mutation carriers (OR(adj) 0.74). In all investigated subgroups the discriminating capacity (measured by the area under the ROC-curve) was higher for MRI than for mammography, with the largest differences for BRCA1/2 mutation carriers (0.237), for women between 40 and 49 years (0.227) and for women with a low breast density (0.237). CONCLUSIONS: This report supports the earlier recommendation that MRI should be a standard screening method for breast cancer in BRCA1/2 mutation carriers.

Adult↗

Differences between first and subsequent rounds of the MRISC breast cancer screening program for women with a familial or genetic predisposition.

BACKGROUND: Within the Dutch MRI Screening (MRISC) study, a Dutch multicenter screening study for hereditary breast cancer, the authors investigated whether previously reported increased diagnostic accuracy of magnetic resonance imaging (MRI) compared with mammography would be maintained during subsequent screening rounds. METHODS: From November 1999 to October 2003, 1909 eligible women were included in the study. Screening parameters and tumor characteristics of different rounds were calculated and compared. The authors defined 3 different types of imaging screening rounds: first round in women never screened by imaging before, first round in women screened by imaging (mainly mammography) before, and subsequent rounds. RESULTS: The difference in sensitivity for invasive cancers between mammography and MRI was largest in the first round of women previously screened with mammography (20.0 vs. 93.3%; P=.003), but also in subsequent rounds, there was a significant difference in favor of MRI (29.4 vs. 76.5%; P=.02). The difference in false-positive rate between mammography and MRI was also largest in the first round of women previously screened with mammography (5.5 vs. 14.0%; P<.001), and it remained significant in subsequent rounds (4.6 vs. 8.2%; P<.001). Screen-detected tumors were smaller and more often lymph node negative than symptomatic tumors in age-matched control patients, but no major differences in tumor stage were found between tumors detected at subsequent rounds compared with those in the first round. CONCLUSIONS: In subsequent rounds, a significantly higher sensitivity and better discriminating capacity of MRI compared with mammography was maintained, and a favorable tumor stage compared with age-matched symptomatic controls. As results of these subsequent screening rounds were most predictive for long-term effects, the authors expect that this screening program will contribute to a decrease of breast cancer mortality in these high-risk women.

Adult↗

Seventy-five years is an appropriate upper age limit for population-based mammography screening.

In this study, we assessed the results of the Dutch breast cancer screening programme for women aged 70-75, and discussed the current upper age limit of the women invited. We compared the main outcome parameters of the screening programme 1998-2000 for women aged 70-75, with those in women aged 50-69. Breast cancer detection rates were also compared with prediction from 2 variants of a simulation model of breast cancer screening, assuming the mean sojourn time, i.e., the duration of the preclinical detectable phase, to increase or not with age above the age of 65. The underlying idea is that an increase of the sojourn time with age will lead to a less favourable balance between screening benefits and harms from a certain age on. Of the 315,103 women (aged 70-75) invited, 65.6% participated. The attendance increased from 1998 to 2000. For women aged 74 and 75 years, this increase was almost 10%. As a result of the 187,207 screening examinations performed within this age group, 18.3 per 1,000 women were referred and 10.3 per 1,000 breast cancer were diagnosed. Detection rates in both initial and subsequent screens increased steadily with age and got close to those model-simulated rates, which assume a continuously increasing sojourn time with age. A major finding of this study is that the screening participation among elderly women is high. The outcomes of our study suggest a steadily increasing sojourn time of breast tumours beyond the age of 69, leading to a strong increase in detection of cancers, and therefore, disfavouring the balance with the benefits of screening. At present, 75 years of age can be regarded as an appropriate upper age limit for the Dutch programme.

Age Factors↗

Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment.

For treatment of teenagers with progressive adolescent idiopathic scoliosis in an early stage, two options are generally considered: treatment with a brace or observation followed by surgery if necessary. Many doctors and patients prefer conservative treatment (i.e. brace treatment) to surgical treatment, because surgery of the spine is generally considered a drastic intervention. Because potential differences in health-related quality of life (HRQoL) after treatment between braced and surgically treated patients are not well explored, this study aimed to determine whether short-term differences exist in HRQoL between adolescents treated with a brace or treated surgically. A cross-sectional analysis of HRQoL was made of 109 patients with adolescent idiopathic scoliosis who, after completing treatment, filled out the Dutch SRS-22 Patient Questionnaire. All patients had been treated either with a brace or surgery, or with a brace followed by surgery. Patients treated surgically had significantly higher mean scores in the satisfaction with management domain than those treated with a brace. No other consistent differences in HRQoL were found between patients treated with a brace and patients treated surgically. Gender, curve type and curve size had no relevant effect on HRQoL. We conclude that short-term differences in HRQoL after treatment in adolescent patients with idiopathic scoliosis are negligible and cannot support preference of one treatment above the other.

Adolescent↗

Patients' perceptions of the side-effects of prostate cancer treatment--a qualitative interview study.

Primary prostate cancer treatment often results in suboptimal urinary, bowel and/or sexual function. These effects are not inevitable. After treatment patients typically report high health related quality of life (QoL) scores. This discrepancy between disease-specific and generic results raises the question which meaning side effects actually have to patients. In a qualitative study we explored two mechanisms which could possibly explain the discrepancy: insensitivity of generic QoL measures to these specific symptoms and adaptation to changed health (response shift). In semi-structured interviews with 33 prostate cancer patients in the Netherlands we collected data on their opinions regarding health and QoL, we observed how respondents behaved when completing health status and QoL questionnaires, and solicited comments on a QoL questionnaire, its items, and its content validity. We observed that patients trivialized sexual (dys) function referring to old age. We found that while they might consider sexual, urinary, and bowel dysfunctions as problems, they did not take such dysfunctions into account when completing QoL measures because they did not view these dysfunctions as aspects of health. This finding reveals a so far unidentified cause of the insensitivity of generic measures of health status. Furthermore, response shift appeared to be present: many patients accepted the side effects as inevitable consequences of having been treated for prostate cancer, a condition they perceived as life threatening. We conclude that generic QoL measures cannot reveal the impact of sexual, urinary and bowel dysfunctions on patients because such dysfunctions are not perceived as health problems. By presenting these findings we want to draw attention to issues that complicate QoL assessments in general and in prostate cancer patients in particular.

Aged↗

The MISCAN-Fadia continuous tumor growth model for breast cancer.

The MISCAN-Fadia model was used to analyze the impact of screening and adjuvant treatment on U.S. breast cancer mortality between 1975 and 2000. MISCAN-Fadia uses the concept of "fatal diameter" to model survival and screening benefit and is based on continuous tumor growth. It consists of four major components: population, natural history, screening, and treatment. Population parameters were quantified using U.S. population data. Most natural history and screening parameters were fitted to the Swedish Two County screening trial data; some were based on Surveillance, Epidemiology, and End Results data. Adjuvant treatment parameters were quantified using data from the Early Breast Cancer Trialists' Collaborative Group's meta-analysis. The simulated trend in incidence matches the observed trend reasonably well; the simulated mortality is equal to the observed in 1975 but becomes increasingly too high in 2000. We estimate that screening leads to a 15% and adjuvant treatment to a 21% mortality reduction in the year 2000.

Antineoplastic Combined Chemotherapy Protocols↗

Internet versus paper mode of health and health behavior questionnaires in elementary schools: asthma and fruit as examples.

The Internet has become an inevitable tool for collecting health and health behavior questionnaires. This study compared the feasibility, presence of score differences, and subjective evaluations by children between Internet and identical paper (asthma/fruit) questionnaires in elementary schools. A randomized crossover design was applied, with children starting with one administration mode before completing (5 minutes later) the other mode. Ten Dutch elementary schools with 270 school children (fifth grade, 10-12 years) were approached to participate. Response was 92%. The Internet mode had significantly less missing/nonunique answers than the paper mode (p < .01). The completion times did not differ significantly between the Internet and the paper mode. Except for perceived self-efficacy to eat sufficient fruit (p < .05), no differences in the asthma and fruit scores were found when comparing between the 2 modes. All variables showed strong intraclass correlation coefficients (166 >or= 0.64) between modes. Most items had good to very good agreement (kappa 0.61-0.95). The percentages for global and exact agreement ranged per item from 61.3 to 100. Most children preferred the Internet mode on "general preference" and "ease of use" aspects but rated no preference on "understandability." The majority rated the evaluation aspects of the Internet mode positively. Thus, Internet administration of a health and health behavior questionnaire is feasible at elementary schools, gives comparable responses, and is well accepted and preferred by children compared to the paper version. Therefore, it is recommended to use Internet as a tool in health and health behavior research among children.

Asthma↗

Screening for scoliosis: do we have indications for effectiveness?

OBJECTIVE: The effectiveness of screening for scoliosis has not been established. This study investigated whether patients with adolescent idiopathic scoliosis detected by screening are detected in an earlier stage of the clinical course, and whether these patients have better outcome than otherwise detected patients. SETTING: The study is a retrospective follow-up study of patients with adolescent idiopathic scoliosis who had completed treatment with a brace, by surgery, or with a brace followed by surgery. Of the 143 patients (born on or after 1 January 1984) consecutively recruited from 12 hospitals in the Netherlands, 125 (87%) agreed to participate. Of these, 51 patients were treated with a brace only and 74 patients were operated on. Screening for scoliosis is carried out in 80% of Dutch children. METHODS: Data on being screen detected or otherwise detected and Cobb angle at diagnosis were collected using youth health-care files, medical files and interviews by telephone with the patients. RESULTS: About 55% of the patients were detected by screening (programme sensitivity). Screen-detected patients had a significantly smaller Cobb angle at diagnosis (28 degrees versus 40 degrees ; P<0.01) and had a 73% lower chance of having had surgery (45% versus 75%; P<0.01) than otherwise-detected patients. CONCLUSION: In the present study, two essential prerequisites necessary for a screening programme for scoliosis to be effective have been met. However, definite proof of the effectiveness of screening still needs to be established because length bias and over-treatment bias cannot be ruled out using this design.

Adolescent↗

Overdiagnosis and overtreatment of breast cancer: microsimulation modelling estimates based on observed screen and clinical data.

There is a delicate balance between the favourable and unfavourable side-effects of screening in general. Overdiagnosis, the detection of breast cancers by screening that would otherwise never have been clinically diagnosed but are now consequently treated, is such an unfavourable side effect. To correctly model the natural history of breast cancer, one has to estimate mean durations of the different pre-clinical phases, transition probabilities to clinical cancer stages, and sensitivity of the applied test based on observed screen and clinical data. The Dutch data clearly show an increase in screen-detected cases in the 50 to 74 year old age group since the introduction of screening, and a decline in incidence around age 80 years. We had estimated that 3% of total incidence would otherwise not have been diagnosed clinically. This magnitude is no reason not to offer screening for women aged 50 to 74 years. The increases in ductal carcinoma in situ (DCIS) are primarily due to mammography screening, but DCIS still remains a relatively small proportion of the total breast cancer problem.

Aged↗

Prostate cancer diagnosis: the impact on patients' mental health.

Because the introduction of PSA testing has increased the reported incidence of prostate cancer, this study assessed the mental impact on men after receiving a diagnosis of prostate cancer. Participants in a prostate cancer screening trial (ERSPC) completed a questionnaire on health and, if diagnosed with prostate cancer, at two additional time points. In the pre-screening phase 3800 men (response 88%) completed the questionnaire. Of screen-diagnosed men (n=82) 52 (response 63%) completed two additional assessments. Gleason scores were < or=7 in 96% of men. Mental and self-rated overall health worsened significantly immediately after diagnosis (P < or=0.04). Six months later these scores improved and no longer differed significantly from the pre-diagnosis score. After obtaining a pre-diagnosis assessment in prospective prostate cancer patients we found a significant negative mental impact of prostate cancer diagnosis based on PSA testing. We recommend that clinicians share their knowledge on the generally favourable prognosis with their patients. The methodological implication is that considering a post-diagnosis assessment as 'baseline' may lead to an underestimation of the patient's mental health.

Aged↗

Five-year follow-up of health-related quality of life after primary treatment of localized prostate cancer.

Although with earlier detection of prostate cancer more men face the long-term consequences of primary treatment, studies on the impact of treatment on long-term health-related quality of life (HRQoL) are scarce. We followed 314 men with newly diagnosed localized prostate cancer from 1 month before until 5 years after radical prostatectomy (n = 127) or external beam radiotherapy (n = 187; median follow-up = 52 months). Questionnaires addressing disease-specific (UCLA PCI) and generic (SF-36, EQ-5D) HRQoL were sent 1 month before and 6, 12 and 52 months after treatment. Repeated-measures modeling was used to study HRQoL over time. Regular urinary leakage was reported by 12% of prostatectomy patients before treatment and by 31% at the 52-month assessment. Erectile dysfunction before treatment was reported by 31% of prostatectomy patients and by 40% of radiotherapy patients; at the 52-month assessment, these percentages were 88% and 64%, respectively. Erectile dysfunction present at 1 year posttreatment can be considered permanent. Prostatectomy patients reported better generic functioning both before and after treatment than radiotherapy patients, who were on average 5.9 years older and had more comorbid conditions. General physical functioning of prostatectomy patients slightly improved over time, but declined in radiotherapy patients. The relation between age and physical scores was found to be nonlinear. The long-term physical decline in radiotherapy patients partly resulted from aging and its nonlinear impact on health, although treatment effects cannot be excluded. Scores of both patient groups remained above those of norm populations. Innovative graphs describing disease-specific and generic functions after treatment can help patients and physicians in their treatment choices.

Aged↗

Effect of recall rate on earlier screen detection of breast cancers based on the Dutch performance indicators.

BACKGROUND: The recall rate (i.e., the rate at which mammographically screened women are recalled for additional assessment) in the Dutch breast screening program (0.89% in 2000 for subsequent examinations) is the lowest worldwide, with possible consequences including higher rates of late-detected (i.e., "missed") interval and screen-detected cancers. To estimate the effect of changes in recall rate on earlier detection of cancers, we carried out a blinded review of interval and screen-detected cancers in the Dutch screening program. METHODS: A total of 495 sets of screen-negative mammograms (prediagnostic mammogram and the immediate previous mammogram) were collected from women participating in the biennial Dutch screening program. Of these, 250 were from control subjects, and 245 were from women who were subsequently diagnosed with breast cancer (123 interval and 122 screen-detected cancers). These mammograms were read by 15 radiologists who specialize in screening mammography and were blinded to outcome. Mean detection sensitivities for different false-positive rates were calculated using a linear mixed model. These results were used to calculate the effect of recall rate adjustment on earlier detection of cancers and numbers of false-positives. RESULTS: Increasing the recall rate to 2.0% would increase the detection rate from 4.20 per thousand to 4.52 per thousand due to the earlier detection of interval cancers. Moreover, 0.54 per thousand of the screen-detected cancers would be detected 2 years earlier (late screen-detected cancers). At recall rates of 3.0% and 4.0% the detection rate would increase to 4.58 per thousand and 4.63 per thousand, respectively, and 0.64 per thousand and 0.72 per thousand, respectively, of the screen-detected cancers would be detected 2 years earlier. For each 1.0% incremental increase in recall rate above 5.0%, the detection rate would increase by approximately 0.03 per thousand, with positive predictive values decreasing to below 10%. CONCLUSION: Breast cancer can be detected earlier by lowering the threshold for recall, especially for recall rates of 1%-4%. With further recall rate increases, cancer detection levels off with a disproportionate increase of false-positive rates.

Breast Neoplasms↗