Empirical treatment or prompt endoscopy.
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Cost-Benefit Analysis↗
Biomedical subjects
J L Severens
Publications and source records attributed to J L Severens.
Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial.
BACKGROUND: Cognitive behaviour therapy (CBT) seems a promising treatment for chronic fatigue syndrome (CFS), but the applicability of this treatment outside specialised settings has been questioned. We compared CBT with guided support groups and the natural course in a randomised trial at three centres. METHODS: Of 476 patients diagnosed with CFS, 278 were eligible and willing to take part. 93 were randomly assigned CBT (administered by 13 therapists recently trained in this technique for CFS), 94 were assigned the support-group approach, and 91 the control natural course. Multidimensional assessments were done at baseline, 8 months, and 14 months. The primary outcome variables were fatigue severity (on the checklist individual strength) and functional impairment (on the sickness impact profile) at 8 and 14 months. Data were analysed by intention to treat. FINDINGS: 241 patients had complete data (83 CBT, 80 support groups, 78 natural course) at 8 months. At 14 months CBT was significantly more effective than both control conditions for fatigue severity (CBT vs support groups 5.8 [2.2-9.4]; CBT vs natural course 5.6 [2.1-9.0]) and for functional impairment (CBT vs support groups 263 [38-488]; CBT vs natural course 222 [3-441]). Support groups were not more effective for CFS patients than the natural course. Among the CBT group, clinically significant improvement was seen in fatigue severity for 20 of 58 (35%), in Karnofsky performance status for 28 of 57 (49%), and self-rated improvement for 29 of 58 (50%). Prognostic factors for outcome after CBT were a higher sense of control predicting more improvement, and a passive activity pattern and focusing on bodily symptoms predicting less improvement. INTERPRETATION: CBT was more effective than guided support groups and the natural course in a multicentre trial with many therapists. Our study showed a lower proportion of patients with improvement than CBT trials with a few highly skilled therapists.
Adult↗
Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.
OBJECTIVE: To study the effect of folates on discontinuation of methotrexate (MTX) as single-drug antirheumatic treatment due to toxicity, to determine which type of adverse events are reduced, to study the effects on the efficacy of MTX, and to compare folic with folinic acid supplementation in a 48-week, randomized, double-blind, placebo-controlled trial. METHODS: Patients with active RA (n = 434) were randomly assigned to receive MTX plus either placebo, folic acid (1 mg/day), or folinic acid (2.5 mg/week). The initial MTX dosage was 7.5 mg/week; dosage increases were allowed up to a maximum of 25 mg/week for insufficient responses. Folate dosages were doubled once the dosage of MTX reached 15 mg/week. The primary end point was MTX withdrawal because of adverse events. Secondary end points were the MTX dosage and parameters of efficacy and toxicity of MTX. RESULTS: Toxicity-related discontinuation of MTX occurred in 38% of the placebo group, 17% of the folic acid group, and 12% of the folinic acid group. These between-group differences were explained by a decreased incidence of elevated liver enzyme levels in the folate supplementation groups. No between-group differences were found in the frequency of other adverse events or in the duration of adverse events. Parameters of disease activity improved equally in all groups. Mean dosages of MTX at the end of the study were lower in the placebo group (14.5 mg/week) than in the folic and folinic acid groups (18.0 and 16.4 mg/week, respectively). CONCLUSION: Both folate supplementation regimens reduced the incidence of elevated liver enzyme levels during MTX therapy, and as a consequence, MTX was discontinued less frequently in these patients. Folates seem to have no effect on the incidence, severity, and duration of other adverse events, including gastrointestinal and mucosal side effects. Slightly higher dosages of MTX were prescribed to obtain similar improvement in disease activity in the folate supplementation groups.
Adult↗
Economic evaluation in health care: the usefulness of research guidelines.
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Cost-Benefit Analysis↗
Precision and accuracy in measuring absence from work as a basis for calculating productivity costs in The Netherlands.
The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal viewpoint is used for the analysis. This impact is reflected by calculating productivity costs. Measurement of these costs is often performed retrospectively. The purpose of our study was to study precision and accuracy of a retrospective self-administered questionnaire on sick leave. Employees of a company were asked to indicate the number of days absent from work due to illness during the past 2 weeks, 4 weeks, 2 months, 6 months, and the past 12 months. The percentage of respondents with an absolute difference of a maximum of respectively 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9 or more days between reported, and company-registered absence due to illness was determined. Besides this, the proportional difference was calculated. A systematic difference was tested with a signed rank test. Of the reported data, 95% matched the registered data perfectly when the recall period was limited to 2 and 4 weeks. This percentage decreased to 87%, 57%, and 51% for 2 months, 6 months, and 12 months. The weighted mean proportional differences for the recall periods were respectively 32.9, 35.2, 45.3, 34.9, and 113.6%. No systematic positive or negative difference was found between registered and reported sick leave. The results suggest that the recall period for retrospective measurement of sick leave is limited according to the precision level, which seems to be appropriate for the subject and the purpose of the study. We recommend using a recall period of no more than 2 months.
Costs and Cost Analysis↗
Prostate cancer staging: should MR imaging be used?--A decision analytic approach.
PURPOSE: To determine the appropriate use of magnetic resonance (MR) imaging for preoperative staging of prostate cancer. MATERIALS AND METHODS: Literature review was performed by using the principles of evidence-based medicine and medical technology assessment. A decision analytic model was used to compare (a) the strategy that radical prostatectomy is performed on the basis of clinical staging with (b) the strategy that extracapsular disease detected at MR imaging contraindicates radical prostatectomy in patients who were considered surgical candidates on the basis of clinical staging. RESULTS: After review of the literature, expert panel opinion did not recommend MR staging. No studies in which therapeutic efficacy was addressed were found. The decision analytic model indicated that the strategy including MR staging decreased costs (MR imaging, $10,568; radical prostatectomy, $11,669) and resulted in almost equal life expectancy (MR imaging, 12.59 years; radical prostatectomy, 12.60 years) and quality-adjusted life-years ([QALYs] MR imaging, 12.53; radical prostatectomy, 12.52). Results of sensitivity analyses demonstrated that the MR strategy was both more effective and less costly if the prior probability of extracapsular disease was at least 39% when considering QALY and 50% when considering unadjusted life expectancy. CONCLUSION: It is not yet conclusively determined whether preoperative MR staging is appropriate, but results of decision analysis suggest that MR staging is cost-effective for men with moderate or high prior probability of extracapsular disease.
Contraindications↗
Adjuvant physical therapy versus occupational therapy in patients with reflex sympathetic dystrophy/complex regional pain syndrome type I.
OBJECTIVE: To investigate the effectiveness and cost of physical therapy (PT) or occupational therapy (OT) in patients with reflex sympathetic dystrophy (RSD). DESIGN: Prospective randomized controlled trial, with 1 year follow-up. SETTING: Two university hospitals. PATIENTS: One hundred thirty-five patients who had been suffering from RSD of one upper extremity for less than 1 year. INTERVENTIONS: Patients were assigned to PT, OT, or a control group (social work). MAIN OUTCOME MEASURES: Improvement in impairment level sumscore (ISS) over 1 year (Student's t test). A difference of 5 ISS points between the groups was defined as being clinically relevant. Furthermore, severity of disability and handicap was measured and tested exploratively (Wilcoxon; alpha = .05), and cost-effectiveness of the groups was calculated. RESULTS: PT and, to a lesser extent, OT resulted in a significant and also more rapid improvement in the ISS as compared with controls (6 and 4 ISS points, respectively). On a disability level, a positive trend was found in favor of OT. On a handicap level, no differences were found between the groups. PT had an advantage over OT regarding the cost-effectiveness ratio. CONCLUSION: In different ways PT and OT each contribute to the recovery from RSD of the upper extremity.
Female↗
Cost-effectiveness analysis of adjuvant physical or occupational therapy for patients with reflex sympathetic dystrophy.
OBJECTIVE: To study from a societal viewpoint the cost-effectiveness of adjuvant treatment for patients with reflex sympathetic dystrophy (RSD) of one upper extremity. DESIGN: A two-center randomized clinical trial comparing pairwise physical therapy (PT), occupational therapy (OT), and control treatment (CT). PATIENTS: One hundred thirty-five patients with RSD for less than 1 year participated. INTERVENTIONS: PT and OT were given according to protocols. For CT, services by social workers were offered. MAIN OUTCOME MEASURES: The Impairment-level Sum Score (ISS), the modified Greentest, and the Sickness Impact Profile (SIP) were used to determine effectiveness. Real medical costs, nonmedical costs, and productivity costs were distinguished and incremental cost-effectiveness ratios were calculated. Sensitivity analyses were performed on cost estimates. RESULTS: The ISS, but not the Greentest and SIP, showed a significant difference between PT versus OT and CT. The mean adjuvant treatment costs were significantly higher for PT (Netherlands Guilders [NLG] 1,726) and OT (NLG 2,089) compared with CT (NLG 903). The mean total medical costs were not significantly different for the groups (PT, NLG 8,692; OT, NLG 13,023; and CT, NLG 7,888) (intention-to-treat analysis). The sensitivity analyses showed a moderate influence of the cost estimates. CONCLUSIONS: PT results in clinically relevant improvement in RSD. Costs associated with adjuvant treatment are moderate compared to other medical costs. The incremental cost-effectiveness ratios of PT versus OT and CT were moderate or even dominant, thus PT was both more effective and less costly than its comparators.
Adult↗
Economic evaluation of diagnostic tests. A review of published studies.
OBJECTIVES: The purpose of this review was to examine whether studies from the medical literature focusing on efficiency of diagnostic facilities reported economic evaluation methods appropriately, following guidelines for conducting and reporting economic evaluations. METHODS: A Medline search was conducted, and studies that concerned a diagnostic technology and fulfilled the Drummond criteria were selected for methodological review. The reliability of selection and methodological review based on the abstracts was determined by scoring a random sample of both abstracts and full articles. Interrater reliability was determined by scoring a random sample of abstracts by both authors. Kappa values were calculated. Nine methodological aspects were reviewed: study design, the type of economic evaluation, the comparison made, the study's perspective, the cost-effectiveness ratio used, the definition of cost-effective, the types of costs analyzed, the cost calculation method, and the use of sensitivity analysis. RESULTS: Two hundred fifty studies published between 1992 and 1997 were found regarding efficiency of diagnostic facilities; 134 studies fulfilled the Drummond criteria and were selected for methodological review. Kappa values showed reliability of selection and methodological review and interrater reliability. The existing literature on the economic evaluation of diagnostic facilities does not adhere well to guidelines for economic evaluation. In 95%, no perspective was mentioned, in 50% of the cases no ratio was given, in 82% the cost calculation method was not mentioned, and in 66% no sensitivity analysis was reported. CONCLUSIONS: Our review suggests that to improve the quality of reporting economic evaluations, editorial boards could issue and enforce guidelines for standard reporting of such studies.
Cost-Benefit Analysis↗
The prognostic value of gastrointestinal morbidity for gastric cancer.
OBJECTIVE: A history of gastrointestinal disease is a risk factor for organic gastrointestinal disorders overall. We conducted a retrospective case-control study to explore whether a history of gastrointestinal disease is of prognostic value for gastric cancer. METHODS: Forty-six patients with gastric cancer were identified from a dynamic population of approximately 12,000 patients followed since 1971 in four general practices. The control subjects without gastric cancer were matched one-on-one according to age, general practice, sex and observation period. Data on gastrointestinal morbidity in the period before gastric cancer was diagnosed were obtained from the Continuous Morbidity Registration. RESULTS: The mean observation period between the date of enrolment in the registration and the first diagnosis of gastric carcinoma was 12 years. Although every patient with gastric cancer ultimately will develop gastrointestinal complaints, 28 of these patients had no previous gastrointestinal morbidity, in comparison with 26 control subjects. Furthermore, patients who developed gastric cancer did not have more frequent gastrointestinal morbidity in their past than the control subjects (odds ratio 0.80, 95% CI 0.32-2.03). CONCLUSIONS: Our results suggest that a history of gastrointestinal morbidity is not of prognostic value for gastric cancer. Focusing attention on patients with a past history of gastrointestinal symptoms to detect gastric cancer may be of little value.
Aged↗
Socio-economic consequences of rheumatoid arthritis in the first years of the disease.
OBJECTIVE: Few data have been presented to document the impact of rheumatoid arthritis (RA) on socio-economic well-being. In this study, exact figures on socio-economic consequences were assessed. METHODS: The socio-economic consequences were studied in an inception cohort (186 early RA patients, mean disease duration 3 yr) by measuring the change in work capability, income, rest during the daytime, leisure time activity, transport mobility, housing and social support occurring in the first years of the disease. RESULTS: For 89% of the patients, RA had an impact on one of the socio-economic items; for 58%, at least three of these items were affected simultaneously. Work disability appeared to be 4-15 times higher than in the general population. After 3 yr, 42% of the patients were registered as work disabled. Nearly a quarter of the patients experienced income reduction. Over 40% of the patients claimed extra rest during the daytime. Leisure activity changed towards activities with a lower joint load. There was a decline in transport mobility for 52% of the patients. Social support increased strongly. CONCLUSIONS: Socio-economic change already presents in the first years of RA and appears to be influenced by age, gender, marital status and work disability. Furthermore, physical limitation appeared to be predictive for work-related income reduction, reduced transport mobility and development of social dependency.
Activities of Daily Living↗
Optimizing diagnostic test sequences: the probability modifying plot.
The problem of deciding the optimal sequence of diagnostic tests can be structured in decision trees, but unmanageable bushy decision trees result when the sequence of two or more tests is investigated. Most modelling techniques include tests on the basis of gain in certainty. The aim of this study was to explore a model for optimizing the sequence of diagnostic tests based on efficiency criteria. The probability modifying plot shows, when in a specific test sequence further testing is redundant and which costs are involved. In this way different sequences can be compared. The model is illustrated with data on urinary tract infection. The sequence of diagnostic tests was optimized on the basis of efficiency, which was either defined as the test sequence with the least number of tests or the least total cost for testing. Further research on the model is needed to handle current limitations.
Decision Support Techniques↗
Uncertainty of incremental cost-effectiveness ratios. A comparison of Fieller and bootstrap confidence intervals.
OBJECTIVE: To compare different methods to estimate the confidence interval of the incremental cost-effectiveness ratio (ICER). METHODS: The adequacy of Fieller intervals and three methods for calculating bootstrap intervals are compared based on a simulation of 10,000 trials, using data from one trial. RESULTS: Both Fieller and bootstrap methods lead to unsatisfactory results when the difference in effectiveness is approximately zero. Where this difference is significant, the four methods for calculating confidence intervals for ICER do not give very different results, but Fieller's interval performs best. CONCLUSIONS: Since Fieller's confidence limits are relatively easy to compute compared with bootstrap simulations, we recommend using this method.
Child↗
Prevalence of antibodies to Histoplasma capsulatum among Dutch speleologists.
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Adult↗
Estimating the cost of lost productivity in dyspepsia.
BACKGROUND: In the field of gastrointestinal disease, productivity costs are highly relevant because work loss is substantial in dyspeptic patients. Productivity costs are normally calculated by multiplying days absent valued by gross earnings. This, however, might lead to an overestimation. AIM: To use a conservative approach to calculating productivity costs, taking absence compensating mechanisms into account. METHODS: Patients who visited their general practitioner for the first time with dyspeptic complaints and patients who were known to have persistent dyspeptic complaints were enrolled in two studies. In total, 136 patients completed a questionnaire about their employment situation, absence from work and absence compensating mechanisms. RESULTS: Sixty-six of the respondents had a paid job, of which 25 (38%) reported absence from work during the previous 4 weeks (average 3.0 days, 1.9 days related to dyspeptic complaints). More than 50% of the employed respondents answered that absence could be compensated for by colleagues, and only in 8% of the cases was absence compensated for by overtime. Using our conservative approach, only one-quarter of the productivity costs remained, compared to the current approach of valuing each day absent as a loss of productivity. CONCLUSIONS: We suggest using both the current and the conservative approaches, analogous to the principles of sensitivity analysis, to avoid overestimation of productivity costs.
Adult↗
Randomized controlled trial of omeprazole or endoscopy in patients with persistent dyspepsia: a cost-effectiveness analysis.
BACKGROUND: Cost-effectiveness analysis, Helicobacter pylori research and the development of proton pump inhibitors are having an increasing impact on the management of dyspepsia. However, clinical trials have not always included both H. pylori diagnosis and proton pump inhibitors in their protocols. METHODS: Patients who were referred for upper gastrointestinal endoscopy by their general practitioner were randomized to either prompt endoscopy followed by directed medical treatment (conventional group, n=38), or to empirical treatment with omeprazole and, in the case of symptom relapse, serological screening for H. pylori infection followed by eradication therapy in seropositive patients (empirical group, n=42). The study lasted for up to 1 year. RESULTS: In the empirical group, only 13 patients (31%) underwent endoscopy. The average number of days for which the patients kept records of their dyspeptic symptoms was 266 (95% CI: 226-307) in the empirical group, of which 166 (95% CI: 128-204) were symptom-free. In the conventional group, 159 (95% CI: 119-198) out of 255 days (95% CI: 209-302) were recorded as symptom-free. The average medical cost in the empirical group was $284 (95% CI: 218-350) and in the conventional group $491 (95% CI: 383-600). In the empirical group, two malignancies were found, whereas in the conventional group one malignancy was found. CONCLUSIONS: The empirical drug treatment strategy in patients with persistent dyspeptic symptoms resulted in 69% fewer diagnostic endoscopies with lower medical costs and equal effectiveness in the first year, compared to prompt endoscopy followed by directed medical treatment.
Adult↗
Cost effectiveness of treatment for gastro-oesophageal reflux.
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Anti-Ulcer Agents↗
Short-term cost-effectiveness analysis of presurgical orthopedic treatment in children with complete unilateral cleft lip and palate.
OBJECTIVE: The aim of this article was to investigate cost-effectiveness in cleft palate treatment using cost-effectiveness of presurgical orthopedic treatment (PSOT) as an example. DESIGN: A three-center randomized clinical trial compared PSOT with non-PSOT for children with unilateral cleft lip and palate (UCLP, n=52). PATIENTS: The inclusion criteria for the trial were: complete UCLP, no other malformations, born at term, both parents Caucasian, trial entrance preferably within 2 weeks after birth, and informed consent by the parents. INTERVENTIONS: PSOT was performed by means of a passive plate according to Hotz and Gnoinski. MAIN OUTCOME MEASURE: The short-term cost-effectiveness of PSOT was based on the time taken for the surgical lip closure procedure. Medical and nonmedical costs until surgical lip closure at 18 weeks of age were analyzed. RESULTS: The durations of the surgical lip closure procedures did not differ significantly (57.2 minutes for PSOT and 56.4 minutes for non-PSOT). The mean medical cost for PSOT treatment was US$852. The non-PSOT treatment group had a significantly different mean medical cost (US$304). Mean travel costs and indirect nonmedical costs were US$128 and US$231 for PSOT and US$79 and US$130 for non-PSOT, respectively. CONCLUSIONS: The combination of a clinical trial and an economic evaluation makes it possible to relate effects to costs involved in treatment alternatives. Longer-term costs and effects will be incorporated into an extended cost-effectiveness analysis to determine the cost-effectiveness of PSOT.
Analysis of Variance↗