A decision-analytic approach to obtain evidence-based vascular follow-up practices.
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Decision Support Techniques↗
Biomedical subjects
J Kievit
Publications and source records attributed to J Kievit.
What do women really want to know? Motives for attending familial breast cancer clinics.
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Adolescent↗
Patients' preferences for adjuvant chemotherapy in early-stage breast cancer: is treatment worthwhile?
When making decisions about adjuvant chemotherapy for early-stage breast cancer, costs and benefits of treatment should be carefully weighed. In this process, patients' preferences are of major importance. The objectives of the present study were: (1) to determine the minimum benefits that patients need to find chemotherapy acceptable, and (2) to explore potential preference determinants, namely: positive experience of the treatment, reconciliation with the treatment decision, and demographic variables. Preferences were elicited from patients scheduled for adjuvant chemotherapy (chemotherapy group: n = 38) before (T(1)), during (T(2)), and 1 month after chemotherapy (T(3)), and were compared to responses from patients not scheduled for chemotherapy (no-chemotherapy group: n = 38). The patients were asked, for a hypothetical situation, to indicate the minimum benefit (in terms of improved 5-year disease-free survival) to find adjuvant chemotherapy acceptable. In the chemotherapy group, the median benefit was 1% at all 3 measurement points. In the no-chemotherapy group the attitude towards chemotherapy became more negative over time, although not statistically significantly so (T(1): 12%, T(2): 15%, T(3): 15%; P = 0.10). At all measurement points, the patients in the chemotherapy group indicated that they would accept chemotherapy for significantly (P< 0.01) less benefit than the patients in the no-chemotherapy group. Of the demographic variables, age was related to preferences, but only at T(2)and only in the no-chemotherapy group. The more positive attitude towards chemotherapy and the stability of preferences in the chemotherapy group indicated that reconciliation with the treatment decision was a more important determinant of patients' preferences than positive experience of the treatment.
Adult↗
How women with a family history of breast cancer and their general practitioners act on genetic advice in general practice: prospective longitudinal study.
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Adult↗
Antibiotic prescription for acute sinusitis in otherwise healthy adults. Clinical cure in relation to costs.
OBJECTIVE: To determine which treatment strategy offers the most cost-effective option in managing acute sinusitis. DESIGN: The modelling procedure included five clinical strategies, varying from "wait and see for a week", to "prescribing antibiotics selectively" to "prescribing antibiotics immediately" and to "performing further diagnostics". SETTING: Outpatient clinics and primary health care. PATIENTS: Data were derived from clinical trials that included otherwise healthy patients with acute sinusitis. MAIN OUTCOME MEASURES: The marginal cost-effectiveness. RESULTS: By using the strategy "wait and see for a week", 91.5% of the patients, by "prescribing antibiotics selectively", 93.2%, of the patients, and by "prescribing antibiotics immediately", 94.5% of the patients were cured after a 1-week period. The costs for curing one additional patient were Dutch Florin (DFL) 516 when antibiotics were selectively prescribed, and DFL 882 when antibiotics were immediately prescribed. Further diagnostic procedures did not improve outcome in terms of marginal cost-effectiveness. CONCLUSIONS: In patients presenting with acute sinusitis, postponing antibiotics for 1 week is the most cost-effective strategy.
Acute Disease↗
Improving the quality of surgeons' treatment decisions: a comparison of clinical decision making with a computerised evidence based decision analytical model.
OBJECTIVES: The purpose of this study is to demonstrate to what extent an evidence based decision model can improve physicians' decisions and whether a selective use of the decision model is feasible. METHODS: Four experienced vascular surgeons were asked to make a treatment decision for 137 "paper patient" cases with asymptomatic abdominal aneurysms. Their decisions were compared with the optimal treatment as calculated by a computerised evidence based decision analytical model. RESULTS: Surgeons agreed with the model's advice based on life expectancy in 81% of the cases, and decided to operate in only 12% of the cases for which there was no agreement. Surgeons' decisions differed from the decision model's calculated optimal treatment, in particular, for older patients with aneurysms of intermediate size and with many risk factors, and for younger patients with small aneurysms and few risk factors. Not all these decisions, however, were reported to be more difficult. CONCLUSION: Use of a decision analytical model might lead to more appropriate decisions and a better quality of care. Selective use of the decision tool for difficult decisions only would be more efficient but is not yet feasible because reported decision difficulty is not strongly related to disagreement with the decision tool.
Aged↗
High dose chemotherapy followed by autologous peripheral blood stem cell transplantation or conventional pharmacological treatment for refractory rheumatoid arthritis? A Markov decision analysis.
OBJECTIVE: To evaluate the effect of high dose chemotherapy (HDC) followed by autologous hematopoietic stem cell transplantation (ASCT) in comparison to conventional pharmacological therapy in the treatment of patients with refractory, progressively erosive rheumatoid arthritis (RA). METHODS: Decision analysis using a Markov model with a 5.5 year time horizon. Probabilities of transition towards 5 different health states, ranging from 70% improvement to death, were derived from published case reports, patient series, and expert panels. Quality of life (QOL) estimates were obtained from 2 RA clinical trials. Patients were hypothetical cohorts of 50-year-old female patients with progressively erosive, active RA, who failed treatment with methotrexate, combination therapy, and tumor necrosis factor blocking agents. Interventions were HDC + ASCT versus conventional pharmacological treatment with a (combination) therapy of disease modifying antirheumatic drugs. As main outcome measures, we included the number of quality adjusted life years (QALY) after HDC + ASCT compared to conventional therapy. Sensitivity analysis was performed to investigate the influence of treatment related mortality (TRM) and the influence of QOL during HDC + ASCT, and to assess the minimal desired effectiveness of HDC + ASCT for a given TRM of 1% and 10%. RESULTS: HDC + ASCT and conventional pharmacological treatment were equally effective in the base-case analysis (3.48 vs 3.46 QALY). A TRM of less than 3.3% favored HDC + ASCT as the preferred treatment. The analysis showed that when TRM was set at 1%, a relatively short period of efficacy was sufficient to remain the preferred strategy, whereas a TRM of 10% would require a sustained response for several years. CONCLUSION: This model predicted equally favorable effects of HDC + ASCT and conventional therapy in the treatment of refractory RA in the base-case. The minor differences in terms of QALY seem to indicate that clinical decision making should be guided by patient preferences. However, better clinical efficacy might be achieved by adaptation of the treatment regimen of HDC + ASCT and patient selection. The model supports the need for randomized clinical trials and may contribute to an optimal study design.
Antirheumatic Agents↗
Long-term results of total adrenalectomy for Cushing's disease.
The objective of this study was to present the long-term results of total adrenalectomy for Cushing's disease. Forty-four patients undergoing total adrenalectomy for Cushing's disease between 1953 and 1989 at Leiden University Medical Center, The Netherlands, were studied retrospectively. Remission was achieved in 42 patients (95%), with a mean duration of 19 years. Adrenal remnants were observed in 12 patients (27%), and were without clinical consequence in the majority of patients, but caused early recurrent disease in 2 patients. Nine patients (20%) experienced Addisonian crises up to 30 years following treatment. Nelson's syndrome developed in 10 patients (23%) 7-24 years following total adrenalectomy. Prior pituitary irradiation was a protective factor against Nelson's syndrome as it delayed its onset (p = 0.025). On the other hand, subnormal dose or noncontinuous glucocorticoid replacement therapy was associated with increased risk of development of Nelson's syndrome (p = 0.047). The incidence of Nelson's syndrome increased with prolonged follow-up, and female patients seemed to be at increased risk. Quality-of-life assessment showed less favorable scores on mental health and health perception scales, for which no explanation can be found except the long-lasting metabolic effects of Cushing's disease, even when successfully treated. In conclusion, total adrenalectomy remains the final treatment for Cushing's disease. The presence of adrenal remnants which can cause recurrent disease and the development of Nelson's syndrome during prolonged follow-up enhance the need for continued regular follow-up. Pituitary irradiation prior to total adrenalectomy delays the onset of Nelson's syndrome.
Addison Disease↗
Diagnosis and treatment of adrenal incidentaloma. A cost-effectiveness analysis.
Methods of meta-analysis, decision analysis, and cost-effectiveness analysis were applied to the adrenal incidentaloma dilemma. It was shown that the life expectancy of patients with adrenal incidentalomas is decreased by a mean of about 1 year if left undiagnosed and untreated--more in cases of larger incidentalomas. Overall, selective analysis of adrenomedullary hormonal function (by urinary metanephrines) is the most cost-effective strategy. Other strategies, such as more extensive hormonal testing, imaging, and fine needle aspiration cytology may provide better cost-effectiveness in subgroups of patients, identified by signs, symptoms, and incidentaloma morphology. Full adrenal hormonal analysis is indicated in patients with larger (> or = 6 cm) incidentalomas and if the combination of hypertension and hypokalemia suggests Conn's disease. Small or medium-sized adrenal incidentalomas may be ignored if MR imaging or other tests suggest benign pheochromocytoma disorder, or patients are elderly, or both.
Adenoma↗
The effect of individually assessed preference weights on the relationship between holistic utilities and nonpreference-based assessment.
In the assessment of health-related quality of life, nonpreference-based methods usually show only moderate correlations with utility-based measures. One cause may be that patients assign different weights to the various domains of health-related quality of life, for which nonpreference-based methods usually do not allow. Utilities reflect a weighted sum of these domains. The aim of this study is to assess whether the relationship between utility-based methods and nonpreference-based measures improves through the use of individual importance weights for the various domains of health-related quality of life. For this purpose, weights were obtained from 41 early-stage breast cancer patients, both before and during treatment, for seven pre-selected health status attributes representing important domains of health-related quality of life during chemotherapy. The importance weights were combined with the level of functioning on the attributes. These scores were regressed against patients' utilities for their actually experienced health state during chemotherapy, measured by means of a visual analog scale (VAS), a time trade-off (TTO), and a standard gamble (SG). Before weighting, the seven attribute scores were more strongly related to TTO and SG utilities than the nonpreference-based questionnaires. However, when they were combined with the importance weights, only the correlation with the SG utilities improved, and only so with the importance weights obtained before chemotherapy. In this study, assigning individually assessed preference weights to self-reported level of functioning did not result in stronger relationships with utilities.
Adult↗
Response shift in quality of life measurement in early-stage breast cancer patients undergoing radiotherapy.
In medicine, response shift refers to a change--as a result of an event such as a therapy--in the meaning of one's self-evaluation of quality of life. Due to response shift, estimates of side effects of radiotherapy may be attenuated if patients adapt to treatment toxicities. The purpose of our study was to assess to what extent two components of response shift, scale recalibration and changes in values, occur in early-stage breast cancer patients undergoing radiotherapy and to examine what the implications would be for treatment evaluation. In the week before start of post-operative radiotherapy, 46 patients filled out a questionnaire consisting of quality of life items of the SF-36 and the Rotterdam symptom checklist (RSCL) (pretest). During radiotherapy, patients were asked to fill out the questionnaire twice: a posttest (quality of life at that moment) and a thentest (quality of life before treatment, retrospectively), supposedly using the same internal standard. Changes in values were studied by asking the patients on the two occasions to rate the importance of seven attributes representing various domains of quality of life. Patients were also asked whether their quality of life with respect to the measured aspects had changed since the pretest (subjective transition scores). Significant scale recalibration effects were observed in the areas of fatigue and overall quality of life. When the groups were divided according to their subjective transition scores, significant scale recalibration effects were found in case of worsened quality of life for fatigue and overall quality of life, and in case of improved quality of life for fatigue and psychological well-being. The mean importance ratings remained fairly stable over time, except for 'skin reactions', which obtained less importance at the end of radiotherapy than before. In conclusion, effects of scale recalibration were observed that would have significantly affected quality of life evaluations, in that the impact of radiotherapy on fatigue and overall quality of life would have been underestimated. Changes in internal values were observed only for 'skin reactions'.
Adult↗
Treatment of pituitary-dependent Cushing's syndrome: long-term results of unilateral adrenalectomy followed by external pituitary irradiation compared to transsphenoidal pituitary surgery.
BACKGROUND: The preferred treatment of Cushing's disease (CD) nowadays is transsphenoidal pituitary surgery (TPS). Prior to TPS, patients at the Leiden University Medical Centre were treated by unilateral adrenalectomy followed by external pituitary irradiation (UAPI). We report on long-term results of both UAPI and TPS and compare remission, relapse rates, and complications. PATIENTS AND METHODS: A retrospective study was carried out on 130 patients with CD. Patients with pituitary macroadenoma were excluded. Eighty-six and 44 patients underwent UAPI and TPS, respectively. Of these patients, 85 and 41 were evaluable for long-term results. RESULTS: Remission following UAPI and TPS was identical at 64% (54/85 and 27/41). Cumulative relapse was also comparable - 17% (9/54) and 22% (6/27), respectively, - for UAPI and TPS, although the mean follow-up periods were different - 21.4 years and 8.5 years, respectively. Cumulative disease-free survival curves after UAPI and TPS are identical until 5 years of follow-up, but diverge thereafter indicating more sustained remissions following UAPI (P = 0.17, Wilcoxon statistic). Pituitary dysfunction following UAPI (36%) and pituitary surgery (55%) likewise did not differ significantly. However, pituitary dysfunction was an immediate event after TPS, whereas it developed after a mean interval of 17.8 years following UAPI.Low-dose dexamethasone testing during follow-up had no value in predicting therapeutic outcome. CONCLUSIONS: The results of unilateral adrenalectomy followed by external pituitary irradiation do not justify that this therapy is totally abandoned in favour of transsphenoidal pituitary surgery. Unilateral adrenalectomy followed by external pituitary irradiation is a valid therapeutic modality for the treatment of Cushing's disease, and could be considered as alternative to bilateral adrenalectomy and under some circumstances to transsphenoidal pituitary surgery.
Adolescent↗
Colorectal cancer follow-up: a reassessment of empirical evidence on effectiveness.
Colorectal cancer is an important cause of death in the Western world, with a propensity of cancer recurrence even after resection with curative intent. Active follow-up has been advocated as a means to detect cancer recurrence at an earlier stage and thereby improve the survival of colorectal cancer patients. The present study assesses published evidence on the effectiveness of follow-up. Articles were obtained from a 20-year Medline search and from cross-references between articles. Articles were included, scored for quality, and extracted by explicit criteria. Regression analysis and chi-squared analysis was performed to assess (1) whether detection of recurrence at earlier asymptomatic disease stage leads to better post-treatment prognosis, and (2) whether active follow-up does improve overall (quality adjusted) survival, as compared to symptom-guided care only. The relationship between disease stage of recurrence (symptoms, number and size) and survival was analysed from 42 articles, 10 of which provided adequate data. Absence of symptoms and small number of recurrence were significantly related to better survival, smaller size insignificantly so. The potential of active follow-up seemed related to a marginally better outcome, larger gains being found in lower quality studies. Available data do suggest that survival gains vary between 0.5 and 2%, 1% seeming to be a best estimate of overall survival gain. Neither the notion that earlier detection of recurrences does significantly improve outcome, nor the hope that active follow-up provides a statistically and clinically significant gain in (quality adjusted) survival, are so far supported by adequate evidence. Colorectal cancer follow-up still fails to meet the criteria for evidence based medicine.
Chi-Square Distribution↗
The surgical approach to the adrenal gland: a comparison of the retroperitoneal and the transabdominal routes in 326 operations on 284 patients.
BACKGROUND: To compare the results of adrenalectomy using a retroperitoneal and a transabdominal approach, especially for adrenal carcinoma and pheochromocytoma. METHODS: A retrospective study was carried out at the Leiden University Medical Center. Charts of 284 patients who had undergone 326 adrenal operations between 1947 and 1995, including 44 patients with adrenal cancer and 60 patients with pheochromocytoma, were reviewed. The main outcome measures were operation time, blood loss, hospital stay and intra- and post-operative complications. RESULTS: In patients who underwent adrenalectomy (ADX) using a retroperitoneal (RP) approach, duration of operation, intra-operative blood loss, hospital stay and post-operative morbidity compared favourably with those undergoing a transabdominal approach (TA-ADX). However, most of these differences could be explained by the more frequently benign nature and smaller size of the lesions in patients undergoing RP-ADX. However, blood loss remained lower after correction for confounding in all patients undergoing RP-ADX. In patients with larger adrenal lesions, adrenal cancer and pheochromocytoma, that would nowadays be held unsuitable for laparoscopic adrenalectomy, RP-ADX was associated with shorter operation time, less blood loss and less intra-operative complications. CONCLUSION: Although laparoscopic adrenalectomy is the treatment of choice for small and benign adrenal lesions, larger lesions and/or adrenal malignancy require open adrenalectomy. In these cases the retroperitoneal approach is the preferred route.
Adolescent↗
Multiple dose pharmacokinetics of oral transmucosal fentanyl citrate in healthy volunteers.
BACKGROUND: Oral transmucosal fentanyl citrate (OTFC) is a solid form of fentanyl that delivers the drug through the oral mucosa. The clinical utility of multiple doses of OTFC in the treatment of "breakthrough" cancer pain is under evaluation. The aim of this study was to test the hypothesis that the pharmacokinetics of OTFC do not change with multiple dosing. METHODS: Twelve healthy adult volunteers received intravenous fentanyl (15 microg/kg) or OTFC (three consecutive doses of 800 microg) on separate study sessions. Arterial blood samples were collected for determination of fentanyl plasma concentration by radioimmunoassay. The descriptive pharmacokinetic parameters (maximum concentration, minimum concentration, and time to maximum concentration) were identified from the raw data and subjected to a nonparametric analysis of variance. Population pharmacokinetic models for all subjects and separate models for each subject were developed to estimate the pharmacokinetic parameters of fentanyl after multiple OTFC doses. RESULTS: The shapes of the profiles of plasma concentration versus time for each dose of OTFC were grossly similar. No change was noted for maximum concentration or time to maximum concentration over the three doses, while minimum concentration did show a significantly increasing trend. Terminal half-lives for intravenous fentanyl and OTFC were similar. A two-compartment population pharmacokinetic model adequately represented the central tendency of the data from all subjects. Individual subject data were best described by either two- or three-compartment pharmacokinetic models. These models demonstrated rapid and substantial absorption of OTFC that did not change systematically with time and multiple dosing. CONCLUSIONS: The pharmacokinetics of OTFC were similar among subjects and did not change with multiple dosing. Multiple OTFC dosing regimens within the dosage schedule examined in this study can thus be formulated without concern about nonlinear accumulation.
Administration, Oral↗
[Pysical examination--rebound tenderness].
Rebound tenderness is generally practiced in the diagnosis of acute abdominal pain. It is a test that inflicts much discomfort to the patient. Literature data derived from reports assessing the reliability of the diagnosis of acute appendicitis indicate a sensitivity of 0.78-0.91 (pooled: 0.91) and a specificity of 0.48-0.60 (pooled: 0.60) of rebound tenderness. It would appear that rebound tenderness is a test of little specificity (leading to many false positive results) and that it has very little additional value, particularly in the presence of local tenderness and/or rigidity in patients with acute abdominal pain.
Abdomen, Acute↗
The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study.
PURPOSE: To answer the question whether a single fraction of radiotherapy that is considered more convenient to the patient is as effective as a dose of multiple fractions for palliation of painful bone metastases. PATIENTS: 1171 patients were randomised to receive either 8 Gy x 1 (n = 585) or 4 Gy x 6 (n = 586). The primary tumour was in the breast in 39% of the patients, in the prostate in 23%, in the lung in 25% and in other locations in 13%. Bone metastases were located in the spine (30%), pelvis (36%), femur (10%), ribs (8%), humerus (6%) and other sites (10%). METHOD: Questionnaires were mailed to collect information on pain, analgesics consumption, quality of life and side effects during treatment. The main endpoint was pain measured on a pain scale from 0 (no pain at all) to 10 (worst imaginable pain). Costs per treatment schedule were estimated. RESULTS: On average, patients participated in the study for 4 months. Median survival was 7 months. Response was defined as a decrease of at least two points as compared to the initial pain score. The difference in response between the two treatment groups proved not significant and stayed well within the margin of 10%. Overall, 71% experienced a response at some time during the first year. An analysis of repeated measures confirmed that the two treatment schedules were equivalent in terms of palliation. With regard to pain medication, quality of life and side effects no differences between the two treatment groups were found. The total number of retreatments was 188 (16%). This number was 147 (25%) in the 8 Gy x 1 irradiation group and 41 (7%) in the 4 Gy x 6 group. It was shown that the level of pain was an important reason to retreat. There were also indications that doctors were more willing to retreat patients in the single fraction group because time to retreatment was substantially shorter in this group and the preceding pain score was lower. Unexpectedly, more pathological fractures were observed in the single fraction group, but the absolute percentage was low. In a cost-analysis, the costs of the 4 Gy x 6 and the 8 Gy x 1 treatment schedules were calculated at 2305 and 1734 Euro respectively. Including the costs of retreatment reduced this 25% cost difference to only 8%. The saving of radiotherapy capacity, however, was considered the major economic advantage of the single dose schedule. CONCLUSION: The global analysis of the Dutch study indicates the equality of a single fraction as compared to a 6 fraction treatment in patients with painful bone metastases provided that 4 times more retreatments are accepted in the single dose group. This equality is also shown in long term survivors. A more detailed analysis of the study is in progress.
Adult↗
Extent of thyroidectomy in nodular thyroid disease.
OBJECTIVE: To find out which procedure was the safest for each indication for operation in diseases of the thyroid gland. DESIGN: Retrospective study. SETTING: Two teaching hospitals, The Netherlands. SUBJECTS: 599 consecutive patients who had 601 thyroid operations between 1 October 1985 and 1 June 1993. MAIN OUTCOME MEASURES: Incidence of complications, particularly postoperative hypocalcaemia and injuries to the recurrent laryngeal nerve. RESULTS: Accidental injuries to the recurrent laryngeal nerve occurred in 0.7% of the nerves at risk (7/948) and the incidence of permanent hypocalcaemia was 5.2% (31/599). In subtotal procedures (bilateral subtotal thyroidectomy with the remnant left dorsally or total hemithyroidectomy combined with subtotal hemithyroidectomy on the other side with a remnant left at the upper pole) the rate was 11/390 (2.8%) compared with 18/525 (3.4%) after total resections. The corresponding numbers of accidental injuries to the recurrent laryngeal nerve were 2 and 4. CONCLUSIONS: Total thyroidectomies are more likely to be done for malignant disease, so the slightly higher complication rates probably reflect the nature of the disease, which requires more radical resection. Both subtotal procedures can be done with comparable low morbidity.
Adult↗