Evaluation of hospital outcomes: the relation between length-of-stay, readmission, and mortality in a large international administrative database.

BACKGROUND: Hospital mortality, readmission and length of stay (LOS) are commonly used measures for quality of care. We aimed to disentangle the correlations between these interrelated measures and propose a new way of combining them to evaluate the quality of hospital care. METHODS: We analyzed administrative data from the Global Comparators Project from 26 hospitals on patients discharged between 2007 and 2012. We correlated standardized and risk-adjusted hospital outcomes on mortality, readmission and long LOS. We constructed a composite measure with 5 levels, based on literature review and expert advice, from survival without readmission and normal LOS (best) to mortality (worst outcome). This composite measure was analyzed using ordinal regression, to obtain a standardized outcome measure to compare hospitals. RESULTS: Overall, we observed a 3.1% mortality rate, 7.8% readmission rate (in survivors) and 20.8% long LOS rate among 4,327,105 admissions. Mortality and LOS were correlated at the patient and the hospital level. A patient in the upper quartile LOS had higher odds of mortality (odds ratio = 1.45, 95% confidence interval 1.43-1.47) than those in the lowest quartile. Hospitals with a high standardized mortality had higher proportions of long LOS (r = 0.79, p < 0.01). Readmission rates did not correlate with either mortality or long LOS rates. The interquartile range of the standardized ordinal composite outcome was 74-117. The composite outcome had similar or better reliability in ranking hospitals than individual outcomes. CONCLUSIONS: Correlations between different outcome measures are complex and differ between hospital- and patient-level. The proposed composite measure combines three outcomes in an ordinal fashion for a more comprehensive and reliable view of hospital performance than its component indicators.

Testing the construct validity of hospital care quality indicators: a case study on hip replacement.

BACKGROUND: Quality indicators are increasingly used to measure the quality of care and compare quality across hospitals. In the Netherlands over the past few years numerous hospital quality indicators have been developed and reported. Dutch indicators are mainly based on expert consensus and face validity and little is known about their construct validity. Therefore, we aim to study the construct validity of a set of national hospital quality indicators for hip replacements. METHODS: We used the scores of 100 Dutch hospitals on national hospital quality indicators looking at care delivered over a two year period. We assessed construct validity by relating structure, process and outcome indicators using chi-square statistics, bootstrapped Spearman correlations, and independent sample t-tests. We studied indicators that are expected to associate as they measure the same clinical construct. RESULT: Among the 28 hypothesized correlations, three associations were significant in the direction hypothesized. Hospitals with low scores on wound infections had high scores on scheduling postoperative appointments (p-value = 0.001) and high scores on not transfusing homologous blood (correlation coefficient = -0.28; p-value = 0.05). Hospitals with high scores on scheduling complication meetings, also had high scores on providing thrombosis prophylaxis (correlation coefficient = 0.21; p-value = 0.04). CONCLUSION: Despite the face validity of hospital quality indicators for hip replacement, construct validity seems to be limited. Although the individual indicators might be valid and actionable, drawing overall conclusions based on the whole indicator set should be done carefully, as construct validity could not be established. The factors that may explain the lack of construct validity are poor data quality, no adjustment for case-mix and statistical uncertainty.

Fewer cancer reoperations for medullary thyroid cancer after initial surgery according to ATA guidelines.

BACKGROUND: Surgery is still the only curative treatment for medullary thyroid cancer (MTC). We evaluated clinical outcome in patients with locoregional MTC with regard to adequacy of treatment following ATA guidelines and number of sessions to first intended curative surgery in different hospitals. METHODS: We reviewed all records of MTC patients (n = 184) treated between 1980 and 2010 in two tertiary referral centers in the Netherlands. Symptomatic MTC (palpable tumor or suspicious lymphadenopathy) patients without distant metastasis were included (n = 86). Patients were compared with regard to adequacy of surgery according to ATA recommendations, tumor characteristics, number of local cancer reoperations, biochemical cure, clinical disease-free survival (DFS), overall survival (OS), and complications. RESULTS: Adherence to ATA guidelines resulted in fewer cancer-related reoperations (0.24 vs. 0.60; P = 0.027) and more biochemical cure (40.9 vs. 20 %; P = 0.038). Surgery according to ATA-guidelines on patients treated in referral centers was significantly more often adequate (59.2 vs. 26.7 %; P = 0.026). Tumor size and LN+ were the most important predictors for clinical recurrence [relative risk (RR) 4.1 (size > 40 mm) 4.1 (LN+) and death (RR 4.2 (size > 40 mm) 8.1 (LN+)]. CONCLUSIONS: ATA-compliant surgery resulted in fewer local reoperations and more biochemical cure. Patients in referral centers more often underwent adequate surgery according to ATA-guidelines. Size and LN+ were the most important predictors for DFS and OS.

Influences of definition ambiguity on hospital performance indicator scores: examples from The Netherlands.

RESEARCH OBJECTIVE: Reliable and unambiguously defined performance indicators are fundamental to objective and comparable measurements of hospitals' quality of care. In two separate case studies (intensive care and breast cancer care), we investigated if differences in definition interpretation of performance indicators affected the indicator scores. DESIGN: Information about possible definition interpretations was obtained by a short telephone survey and a Web survey. We quantified the interpretation differences using a patient-level dataset from a national clinical registry (Case I) and a hospital's local database (Case II). In Case II, there was additional textual information available about the patients' status, which was reviewed to get more insight into the origin of the differences. PARTICIPANTS: For Case I, we investigated 15 596 admissions of 33 intensive care units in 2009. Case II consisted of 144 admitted patients with a breast tumour surgically treated in one hospital in 2009. RESULTS: In both cases, hospitals reported different interpretations of the indicators, which lead to significant differences in the indicator values. Case II revealed that these differences could be explained by patient-related factors such as severe comorbidity and patients' individual preference in surgery date. CONCLUSIONS: With this article, we hope to increase the awareness on pitfalls regarding the indicator definitions and the quality of the underlying data. To enable objective and comparable measurements of hospitals' quality of care, organizations that request performance information should formalize the indicators they use, including standardization of all data elements of which the indicator is composed (procedures, diagnoses).

Successful and safe introduction of laparoscopic colorectal cancer surgery in Dutch hospitals.

OBJECTIVE: To investigate the safety of laparoscopic colorectal cancer resections in a nationwide population-based study. BACKGROUND: Although laparoscopic techniques are increasingly used in colorectal cancer surgery, little is known on results outside trials. With the fast introduction of laparoscopic resection (LR), questions were raised about safety. METHODS: Of all patients who underwent an elective colorectal cancer resection in 2010 in the Netherlands, 93% were included in the Dutch Surgical Colorectal Audit. Short-term outcome after LR, open resection (OR), and converted LR were compared in a generalized linear mixed model. We further explored hospital differences in LR and conversion rates. RESULTS: A total of 7350 patients, treated in 90 hospitals, were included. LR rate was 41% with a conversion rate of 15%. After adjustment for differences in case-mix, LR was associated with a lower risk of mortality (odds ratio 0.63, P < 0.01), major morbidity (odds ratio 0.72, P < 0.01), any complications (odds ratio 0.74, P < 0.01), hospital stay more than 14 days (odds ratio 0.71, P < 0.01), and irradical resections (odds ratio 0.68, P < 0.01), compared to OR. Outcome after conversion was similar to OR (P > 0.05). A large variation in LR and conversion rates among hospitals was found; however, the difference in outcome associated with operative techniques was not influenced by hospital of treatment. CONCLUSIONS: Use of laparoscopic techniques in colorectal cancer surgery in the Netherlands is safe and results are better in short-term outcome than open surgery, irrespective of the hospital of treatment. Outcome after conversion was similar to OR.

Influences of hospital information systems, indicator data collection and computation on reported Dutch hospital performance indicator scores.

BACKGROUND: For health care performance indicators (PIs) to be reliable, data underlying the PIs are required to be complete, accurate, consistent and reproducible. Given the lack of regulation of the data-systems used in the Netherlands, and the self-report based indicator scores, one would expect heterogeneity with respect to the data collection and the ways indicators are computed. This might affect the reliability and plausibility of the nationally reported scores. METHODS: We aimed to investigate the extent to which local hospital data collection and indicator computation strategies differ and how this affects the plausibility of self-reported indicator scores, using survey results of 42 hospitals and data of the Dutch national quality database. RESULTS: The data collection and indicator computation strategies of the hospitals were substantially heterogenic. Moreover, the Hip and Knee replacement PI scores can be regarded as largely implausible, which was, to a great extent, related to a limited (computerized) data registry. In contrast, Breast Cancer PI scores were more plausible, despite the incomplete data registry and limited data access. This might be explained by the role of the regional cancer centers that collect most of the indicator data for the national cancer registry, in a standardized manner. Hospitals can use cancer registry indicator scores to report to the government, instead of their own locally collected indicator scores. CONCLUSIONS: Indicator developers, users and the scientific field need to focus more on the underlying (heterogenic) ways of data collection and conditional data infrastructures. Countries that have a liberal software market and are aiming to implement a self-report based performance indicator system to obtain health care transparency, should secure the accuracy and precision of the heath care data from which the PIs are calculated. Moreover, ongoing research and development of PIs and profound insight in the clinical practice of data registration is warranted.

Downregulation of CASR expression and global loss of parafibromin staining are strong negative determinants of prognosis in parathyroid carcinoma.

Parathyroid carcinoma is associated with mutations in the HRPT2/CDC73 gene and with decreased parafibromin and calcium-sensing receptor (CASR) expression, but in some cases establishing an unequivocal diagnosis remains a challenge. The aim of our study was to evaluate the prognostic value of CASR and parafibromin expression and of HRPT2/CDC73 mutations in patients with an established diagnosis of parathyroid carcinoma. Data on survival and disease-free survival were obtained from hospital records of 23 patients with an established diagnosis of parathyroid carcinoma in whom CASR and parafibromin expression and HRPT2/CDC73 mutation analyses were available from paraffin-embedded pathological specimens. Kaplan-Meier curves were used for survival analysis. Downregulation of CASR expression, global loss of parafibromin staining and a HRPT2/CDC73 mutation were, respectively, found in 7 (30%), 13 (59%) and 4 (17%) patients, and were associated with, respectively, 16-fold, 4-fold and 7-fold increased risk of developing local or distant metastasis. These findings suggest that although downregulation of CASR expression, global loss of parafibromin staining and mutations in the HRPT2/CDC73 gene are tools of proven value to assist in establishing a diagnosis of parathyroid carcinoma, their absence does not exclude it. Notwithstanding, we demonstrate a significant added value of these markers as strong determinants of increased malignant potential and thus as negative prognostic markers in this malignancy.

Limitations of Tc99m-MIBI-SPECT imaging scans in persistent primary hyperparathyroidism.

BACKGROUND: In primary hyperparathyroidism (PHPT) the predictive value of technetium 99m sestamibi single emission computed tomography (Tc99m-MIBI-SPECT) for localizing pathological parathyroid glands before a first parathyroidectomy (PTx) is 83-100%. Data are scarce in patients undergoing reoperative parathyroidectomy for persistent hyperparathyroidism. The aim of the present study was to determine the value of Tc99m-MIBI-SPECT in localizing residual hyperactive parathyroid tissue in patients with persistent primary hyperparathyroidism (PHPT) after initial excision of one or more pathological glands. METHOD: We retrospectively evaluated the localizing accuracy of Tc99m-MIBI-SPECT scans in 19 consecutive patients with persistent PHPT who had a scan before reoperative parathyroidectomy. We used as controls 23 patients with sporadic PHPT who had a scan before initial surgery. RESULTS: In patients with persistent PHPT, Tc99m-MIBI-SPECT accurately localized a pathological parathyroid gland in 33% of cases before reoperative parathyroidectomy, compared to 61% before first PTx for sporadic PHPT. The Tc99m-MIBI-SPECT scan accurately localized intra-thyroidal glands in 2 of 7 cases and a mediastinal gland in 1 of 3 cases either before initial or reoperative parathyroidectomy. CONCLUSIONS: Our data suggest that the accuracy of Tc99m-MIBI-SPECT in localizing residual hyperactive glands is significantly lower before reoperative parathyroidectomy for persistent PHPT than before initial surgery for sporadic PHPT. These findings should be taken in consideration in the preoperative workup of patients with persistent primary hyperparathyroidism.

Calcitonin and carcinoembryonic antigen doubling times as prognostic factors in medullary thyroid carcinoma: a structured meta-analysis.

CONTEXT: In the management of patients with medullary thyroid carcinoma (MTC), calcitonin doubling time (dt) has gained interest as an independent predictor of recurrence and survival. OBJECTIVE: To perform a structured meta-analysis of the diagnostic value of calcitonin dt, carcinoembryonic antigen (CEA) dt and the combination and to define dt strata with the highest predictive power. Design The study was a meta-analysis using individual data. METHODS: Ten studies containing data on the post-operative kinetics of tumour marker(s) and (recurrence free) survival were included. RESULTS: Calcitonin- and CEA-dt are significant indicators for survival (hazard ratios (HR) 21.52 respectively infinite for dt 0-1 year compared to dt >1 year) and recurrence (HR 5.33 respectively 6.80 for dt 0-1 year compared to dt >1 year). The highest predictive power was found for the dt classification 0-1 year vs. >1 year. CEA dt has a higher predictive value than calcitonin dt in the subgroup of patients for which both parameters were available. CONCLUSION: The dts of both calcitonin and CEA are strong prognostic indicators for MTC recurrence and death. CEA dt has a higher predictive value than calcitonin dt and therefore measuring both tumour markers is essential for proper risk stratification.

Internet-based self-management plus education compared with usual care in asthma: a randomized trial.

BACKGROUND: The Internet may support patient self-management of chronic conditions, such as asthma. OBJECTIVE: To evaluate the effectiveness of Internet-based asthma self-management. DESIGN: Randomized, controlled trial. SETTING: 37 general practices and 1 academic outpatient department in the Netherlands. PATIENTS: 200 adults with asthma who were treated with inhaled corticosteroids for 3 months or more during the previous year and had access to the Internet. MEASUREMENTS: Asthma-related quality of life at 12 months (minimal clinically significant difference of 0.5 on the 7-point scale), asthma control, symptom-free days, lung function, and exacerbations. INTERVENTION: Participants were randomly assigned by using a computer-generated permuted block scheme to Internet-based self-management (n = 101) or usual care (n = 99). The Internet-based self-management program included weekly asthma control monitoring and treatment advice, online and group education, and remote Web communications. RESULTS: Asthma-related quality of life improved by 0.56 and 0.18 points in the Internet and usual care groups, respectively (adjusted between-group difference, 0.38 [95% CI, 0.20 to 0.56]). An improvement of 0.5 point or more occurred in 54% and 27% of Internet and usual care patients, respectively (adjusted relative risk, 2.00 [CI, 1.38 to 3.04]). Asthma control improved more in the Internet group than in the usual care group (adjusted difference, -0.47 [CI, -0.64 to -0.30]). At 12 months, 63% of Internet patients and 52% of usual care patients reported symptom-free days in the previous 2 weeks (adjusted absolute difference, 10.9% [CI, 0.05% to 21.3%]). Prebronchodilator FEV1 changed with 0.24 L and -0.01 L for Internet and usual care patients, respectively (adjusted difference, 0.25 L [CI, 0.03 to 0.46 L]). Exacerbations did not differ between groups. LIMITATION: The study was unblinded and lasted only 12 months. CONCLUSION: Internet-based self-management resulted in improvements in asthma control and lung function but did not reduce exacerbations, and improvement in asthma-related quality of life was slightly less than clinically significant. PRIMARY FUNDING SOURCE: Netherlands Organization for Health Research and Development, ZonMw, and Netherlands Asthma Foundation.

Evaluation of routinely reported surgical site infections against microbiological culture results: a tool to identify patient groups where diagnosis and treatment may be improved.

BACKGROUND: Surgeons may improve their decision making by assessing the extent to which their initial clinical diagnosis of a surgical site infection (SSI) was supported by culture results. Aim of the present study was to evaluate routinely reported SSI by surgeons against microbiological culture results, to identify patient groups with lower agreement where decision making may be improved. METHODS: 701 admissions with SSI were reported by surgeons in a university medical centre in the period 1997-2005, which were retrospectively checked for microbiological culture results. Reporting a SSI was conditional on treatment being given (e.g. antibiotics) and was classified by severity. To identify specific patient groups, patients were classified according to the surgery group of the first operation during admission (e.g. trauma). RESULTS: Of all reported SSI, 523 (74.6%) had a positive culture result, 102 (14.6%) a negative culture result and 76 (10.8%) were classified as unknown culture result (due to no culture taken). Given a known culture result, reported SSI with positive culture results less often concerned trauma patients (16% versus 26%, X2 = 4.99 p = 0.03) and less severe SSI (49% versus 85%, X2 = 10.11 p < 0.01) suggesting that a more conservative approach may be warranted in these patients. The trauma surgeons themselves perceived to have become too liberal in administering antibiotics (and reporting SSI). CONCLUSION: Routine reporting of SSI was mostly supported by culture results. However, this support was less often found in trauma patients and less severe SSI, thereby giving surgeons feedback that diagnosis and treatment may be improved in these cases.

The impact of individualized evidence-based decision support on aneurysm patients' decision making, ideals of autonomy, and quality of life.

BACKGROUND: Patients with an asymptomatic abdominal aneurysm and their surgeon were randomized to receive a general brochure (GB) or an IB presenting survival information and a ranking of the treatment strategies. Before and after receiving the brochure, patients filled out questionnaires on their behavior during the consultation, ideals of patient autonomy, and quality of life. Surgeons answered a short checklist evaluating the consultation. RESULTS: One hundred patients participated, 49 in the intervention, 51 in the control group. The IB group had a better understanding of important issues in the treatment decision, had prepared more questions, and was less satisfied with the duration of the consultation. Their impression that the surgeon perceived them more as a medical problem than a patient with a problem increased. They agreed less with the surgeon's advice and lost some of their belief in "the doctor knows best.'' Beforehand, the IB group had a stronger preference for patient-based decisions, but afterward they displayed more surgeon-based decisions. No effects were seen on patients' quality of life. CONCLUSIONS: Individualized evidence-based information stimulated patients' active involvement but in the context of our study led to less patient-based decisions. Patient-made decisions and patient autonomy should, however, not be equated.

Associations of serum thyrotropin concentrations with recurrence and death in differentiated thyroid cancer.

OBJECTIVE: The relation between serum TSH levels and risk for recurrence or thyroid carcinoma-related death in patients with differentiated thyroid carcinoma has only been studied to a limited extent. DESIGN: We conducted a single-center observational study in 366 consecutive patients with differentiated thyroid carcinoma, who had all been treated according to the same protocol for initial therapy and follow-up. Median duration of follow-up was 8.85 yr. METHODS: The relation between summarizing variables of unstimulated serum TSH concentrations (25th, 50th, and 75th percentiles, the percentage of suppressed and unsuppressed TSH values) and risk for recurrence or thyroid carcinoma-related death was analyzed by Cox survival analyses in patients with at least four TSH measurements. RESULTS: In Cox regression analysis, we found a positive association between serum TSH concentrations and risk for thyroid carcinoma-related death and relapse, even in initially cured patients. The median of the individual TSH concentrations was the best indicator for thyroid carcinoma-related death (hazard ratio 2.03; confidence interval 1.22-3.37) and relapse (hazard ratio 1.41; confidence interval 1.03-1.95). A threshold of 2 mU/liter differentiated best between relapse-free survival and thyroid carcinoma-related death or relapse. CONCLUSION: Our study supports current guidelines, which advise to aim at TSH levels in the low normal range in cured low-risk patients, whereas TSH levels should be suppressed in noncured or high-risk patients.

Single- versus multiple-fraction radiotherapy in patients with painful bone metastases: cost-utility analysis based on a randomized trial.

BACKGROUND: Radiotherapy is an effective palliative treatment for cancer patients with painful bone metastases. Although single- and multiple-fraction radiotherapy are thought to provide equal palliation, which treatment schedule provides better value for the money is unknown. We compared quality-adjusted life expectancy (the overall valuation of the health of the patients) and societal costs for patients receiving either single- or multiple-fraction radiotherapy. METHODS: A societal cost-utility analysis was performed on a Dutch randomized, controlled trial of 1157 patients with painful bone metastases that compared pain responses and quality of life from a single-fraction treatment schedule of 8 Gy with a treatment schedule of six fractions of 4 Gy each. The societal values of life expectancies were assessed with the EuroQol classification system (EQ-5D) questionnaire. A subset of 166 patients also answered additional questionnaires to estimate nonradiotherapy and nonmedical costs. Statistical tests were two-sided. RESULTS: Comparing the single- and multiple-fraction radiotherapy schedules, no differences were found in life expectancy (43.0 versus 40.4 weeks, P =.20) or quality-adjusted life expectancy (17.7 versus 16.0 weeks, P =.21). The estimated cost of radiotherapy, including retreatments and nonmedical costs, was statistically significantly lower for the single-fraction schedule than for the multiple-fraction schedule ($2438 versus $3311, difference = $873, 95% confidence interval [CI] on the difference = $449 to $1297; P<.001). The estimated difference in total societal costs was larger, also in favor of the single-fraction schedule, but it was not statistically significant ($4700 versus $6453, difference = $1753, 95% CI on the difference = -$99 to $3604; P =.06). For willingness-to-pay between $5000 and $40 000 per quality-adjusted life year, the single-fraction schedule was statistically significantly more cost-effective than the multiple-fraction schedule (P< or =.05). CONCLUSIONS: Compared with multiple-fraction radiotherapy, single-fraction radiotherapy provides equal palliation and quality of life and has lower medical and societal costs, at least in The Netherlands. Therefore, single-fraction radiotherapy should be considered as the palliative treatment of choice for cancer patients with painful bone metastases.

Development of a clinical decision tool for suspected scaphoid fractures.

Scaphoid fractures are the most common carpal fractures; their overall incidence is however low. Missing a scaphoid fracture may lead to a non-union with a possible disastrous outcome for the patient; for this reason, treatment of a suspected scaphoid fracture, even without a proven fracture on the first radiograph, has been conservative with plaster treatment. There are many clinical tests developed to diagnose a scaphoid fracture. However not all tests are equally practical, and their sensitivity and specificity are not always known, or are very low. In this study 18 clinical tests were evaluated and a subset of 7 tests remained, which were found to be practical and/or had a high enough sensitivity. A clinical decision protocol was developed using a combination of these seven tests, in order to improve diagnostic accuracy and at the same time reduce unnecessary plaster cast treatment of patients with a suspected scaphoid, who turn out to only have a sprained wrist.

Gene expression of parathyroid tumors: molecular subclassification and identification of the potential malignant phenotype.

Parathyroid tumors are heterogeneous, and diagnosis is often difficult using histologic and clinical features. We have undertaken expression profiling of 53 hereditary and sporadic parathyroid tumors to better define the molecular genetics of parathyroid tumors. A class discovery approach identified three distinct groups: (1) predominantly hyperplasia cluster, (2) HRPT2/carcinoma cluster consisting of sporadic carcinomas and benign and malignant tumors from Hyperparathyroidism-Jaw Tumor Syndrome patients, and (3) adenoma cluster consisting mainly of primary adenoma and MEN 1 tumors. Gene sets able to distinguish between the groups were identified and may serve as diagnostic biomarkers. We demonstrated, by both gene and protein expression, that Histone 1 Family 2, amyloid beta precursor protein, and E-cadherin are useful markers for parathyroid carcinoma and suggest that the presence of a HRPT2 mutation, whether germ-line or somatic, strongly influences the expression pattern of these 3 genes. Cluster 2, characterized by HRPT2 mutations, was the most striking, suggesting that parathyroid tumors with somatic HRPT2 mutation or tumors developing on a background of germ-line HRPT2 mutation follow pathways distinct from those involved in mutant MEN 1-related parathyroid tumors. Furthermore, our findings likely preclude an adenoma to carcinoma progression model for parathyroid tumorigenesis outside of the presence of either a germ-line or somatic HRPT2 mutation. These findings provide insights into the molecular pathways involved in parathyroid tumorigenesis and will contribute to a better understanding, diagnosis, and treatment of parathyroid tumors.

Cost-utility analysis of preoperative radiotherapy in patients with rectal cancer undergoing total mesorectal excision: a study of the Dutch Colorectal Cancer Group.

PURPOSE: To compare the societal costs and the (quality-adjusted) life expectancy of patients with rectal cancer undergoing total mesorectal excision (TME) with or without short-term preoperative radiotherapy (5 x 5 Gy). PATIENTS AND METHODS: We used a Markov model to project the clinical and economic outcomes of preoperative radiotherapy. Data on local recurrence rates, quality of life, and costs were obtained from the patients of a multicenter randomized clinical trial. In this trial, 1,861 patients with resectable rectal cancer from 108 hospitals were randomly assigned for TME surgery with or without preoperative radiotherapy. Outcome measures of the model were life expectancy, quality-adjusted life expectancy, lifetime costs per patient, and the incremental cost-effectiveness ratio. RESULTS: The base case model estimates that the loss of quality of life due to preoperative radiotherapy is outweighed by the gain in life expectancy. Life expectancy increases by 0.67 years; quality-adjusted life expectancy, by 0.39 years; and costs, by $9,800 per patient. The corresponding cost-effectiveness ratio is $25,100 per quality-adjusted life year. Sensitivity analyses indicate that the cost-effectiveness ratio remains acceptable under a wide range of assumptions. CONCLUSION: Assuming that the reduced local recurrence rate does lead to a survival advantage, the cost-utility analysis estimates that the improved survival outweighs the impaired quality of life and the increased costs. We conclude that short-term preoperative radiotherapy in patients with rectal cancer undergoing TME is both effective and cost-effective.

Clinical nature and prognosis of locally recurrent rectal cancer after total mesorectal excision with or without preoperative radiotherapy.

PURPOSE: To document the clinical nature and prognosis of locally recurrent rectal cancer after total mesorectal excision (TME) with or without 5 x 5 Gy preoperative radiotherapy (PRT) and to identify patient-, disease-, and treatment-related factors associated with differences in prognosis after local recurrence. PATIENTS AND METHODS: For 96 Dutch patients with a local recurrence who participated in a multicenter randomized clinical trial, data on treatments and follow-up were gathered from surgeons and radiation and medical oncologists. Twenty-three patients (24%) had previously been treated with PRT plus TME, and 73 patients (76%) had been treated with TME alone. Eighty-one patients (84%) were followed until death; median follow-up time of the alive patients after local recurrence was 21 months (range, 5 to 48 months). RESULTS: Survival after local recurrence in the PRT + TME group was significantly shorter than in the TME group (median survival, 6.1 v 15.9 months; hazard ratio for death, 2.1; P =.008). Patients with a local recurrence in the PRT + TME group had distant metastases more often (74% v 40%; P =.004), underwent surgical resection of local recurrence less often (17% v 35%; P =.11), and received radiotherapy for local recurrence at a total dose >/= 45 Gy less often (4% v 42%; P =.001) than patients without PRT. In a multivariate analysis, the difference in survival after local recurrence between randomization groups was no longer statistically significant (hazard ratio for death of PRT, 1.53; P =.16). CONCLUSION: The clinical nature and prognosis of patients with locally recurrent rectal cancer has changed since the introduction of PRT. The majority of patients who present with a local recurrence after previous PRT have simultaneous distant metastases, and median survival has decreased to 6 months.

[Re-use of medical data for research. What do the Dutch think of the requirement for explicit consent?]. / Hergebruik van medische gegevens voor onderzoek. Wat vindt de Nederlander van het toestemmingsvereiste?

OBJECTIVE: How do healthcare consumers perceive the use of medical data for scientific research, within the framework of protection of their personal data? DESIGN: Survey among 731 members of the Healthcare Consumer Panel of the Netherlands Institute for Health Services Research (NIVEL). METHOD: A written and online questionnaire was used, consisting of general questions and 4 cases per respondent. The questions concerned the degree of trust respondents have in the use of previously registered data for different kinds of healthcare research, and their willingness to make data available under various conditions without being asked for explicit consent. RESULTS: Respondents showed a high degree of trust in scientific researchers and physicians concerning the re-use of medical data for research. A majority agreed that it is not necessary to be explicitly asked for consent for this kind of research, providing they are informed: one-third found their autonomy in being able to decide to be more important than scientific progress; three-quarters found explicit permission unnecessary as long as the data is well-protected and only used for scientific research. CONCLUSION: Data protection in research should be proportional to the risks of misuse and the benefits of the use of the data for research. A large majority of healthcare users trust the researchers, and the existing codes of conduct protect data sufficiently. Therefore, we see no need for stricter requirements for the use of health data, which would unnecessarily limit healthcare research. We do consider greater transparency about the research process to be necessary, in order to maintain a proper balance between personal-data protection and the need to emphasise the necessity for learning in the healthcare system.

Routine duplex surveillance does not improve the outcome after carotid endarterectomy: a decision and cost utility analysis.

BACKGROUND: Doppler ultrasound (duplex) tests are commonly applied after carotid endarterectomy to detect possible recurrent stenosis. The appropriate frequency and the benefits are unknown. We investigated the costs and effects of various follow-up strategies to determine the optimal strategy after carotid endarterectomy. METHODS: Using decision-analytic methods, a Monte Carlo Markov model was constructed. Probabilities and costs were obtained by systematic literature review. From empirical data regarding restenosis, a disease model was constructed to test the effect of various follow-up strategies using duplex testing and angiography. Main outcome measures were quality-adjusted life-years (QALYs), probability of stroke, and costs (for both the Dutch and the American situation). RESULTS: The average quality-adjusted life expectancy for a 66-year-old patient was 6.31 years for the symptom-guided strategy (with duplex scanning only being performed in case of symptoms of cerebral ischemia). The mean lifetime costs for this strategy were $5 600 for the US and 4 600 Euro for the Netherlands. The cumulative probability of stroke was 13%. Yearly routine duplex tests up to 5 years after operation resulted in similar QALYs and a similar probability of stroke, but higher costs ($7 300 for the US and 5 600 Euro for The Netherlands situation). No other strategy, including routine duplex surveillance, increased QALYs. When MR instead of conventional angiography was used as confirmatory test, no improvement was observed either. CONCLUSIONS: Routine duplex surveillance does not result in an increase in quality-adjusted life expectancy, but it does increase costs. After successful carotid endarterectomy, a symptom-guided follow-up is an appropriate approach.