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Biomedical subjects

G J van der Wilt

Publications and source records attributed to G J van der Wilt.

At least 19 recordsLinked to original sources

Diagnosis and treatment of acute appendicitis in children: a survey among Dutch surgeons and comparison with evidence-based practice.

BACKGROUND: Considerable variability exists in the surgical approach to acute appendicitis in children, affecting both quality and costs of care. A national survey provides insight into daily surgical practice and enables comparison of practice with the available evidence. METHODS: A national survey was conducted in all 121 Dutch hospitals asking detailed information concerning diagnosis and treatment of children suspected of acute appendicitis. An evidence-based practice (EBP) score was developed on the basis of a critical appraisal of the literature, allowing for classification of reported practices with regard to the level of evidence and identification of hospitals working in accordance with the best available evidence. RESULTS: The overall response rate was 93%. For the diagnosis of acute appendicitis, respondents relied predominantly on patient history (29%) and clinical examination (31%), followed by laboratory results (22%). Only 20% of the departments routinely measured total white blood cell count (WBC), C-reactive protein (CRP) and leukocyte differential count (proportion of polymorphonuclear cells), being part of the triad that provides diagnostic evidence. Although strong evidence exists in favour of routine prophylaxis for suspected appendicitis, only two thirds of surgical departments reported this as part of their routine practice. For a number of issues, reasonably consistent evidence is available (e.g. primarily versus delayed closure, drainage versus lavage, routine peritoneal culturing). Thirty-eight percent of the departments routinely cultured abdominal fluid despite various reports that it provides no therapeutic advantage. Not more than 22% of the departments closed the skin in perforated appendicitis in spite of clear supportive evidence. Considerable variation exists in cleaning the abdomen in perforated appendicitis, despite evidence favouring lavage. Comparing departments in terms of compliance with available evidence revealed that most paediatric surgery departments worked according to evidence-based medicine. CONCLUSIONS: Available evidence on diagnosis and treatment of acute appendicitis in children is only partly applied in a small proportion of hospitals in the Netherlands. It is recommended that national guidelines be published, which could decrease health care costs and increase more uniform policy, improve quality of care for this group of patients and improve training of residents in general surgery in the Netherlands.

Acute Disease↗

Timing of surgery for primary exotropia in children.

OBJECTIVE: To compare postoperative alignment and sensory functions in children with primary exotropia who were operated at an early age (< 7 years) with patients who were operated at an older age (> 7 years). METHODS: In a consecutive retrospective cohort study, 112 patients who had a surgical intervention for primary exotropia between 1997 and 2003 were evaluated for postoperative results. After applying criteria for eligibility, the group of patients was divided into two groups: those who had surgical intervention before the age of seven years (n = 24) and those who had surgery after the age of seven years (n = 36). Age at surgery, preoperative alignment and sensory functions were correlated with the postoperative status. The follow-up was at least one year (1.0 year to 7 years; median: 2.3 and 3.5 years, respectively). RESULTS: Children who had surgery before the age of seven had significantly better alignment and sensory functions. The univariate logistic regression model confirmed a statistically significant association between motor outcome (exodeviation less than 10 prism-diopters) and age at the time of surgery (before or after the age of seven; p = 0.002). In the multivariate model, the association between age at time of surgery and motor outcome was even stronger. The number of reoperations in the group operated before the age of 7 years was significantly less than in the group operated after the age of seven (2 versus 12, p = 0.023). CONCLUSION: The postoperative alignment and sensory functions in patients with primary exotropia who had surgical intervention before the age of seven years were, in this study, better than in patients who had surgery after the age of seven years.

Child↗

Cost-effectiveness of new guidelines for adjuvant systemic therapy for patients with primary breast cancer.

BACKGROUND: In this study, the potential impact of a new national guideline for adjuvant systemic therapy in breast cancer (introduced in The Netherlands in 1998) was assessed, as well as the modifications of this guideline, issued in 2001. Both the change in total number of patients eligible for adjuvant therapy, as well as the cost-effectiveness of the changed clinical management of these patients were analysed. PATIENTS AND METHODS: Percentages of patients who would be eligible for adjuvant therapy in 1994, 1998 and 2001 were estimated, based on clinical data from 127 patients, who were operated on in 1994. Ten-year overall survival rates were used as a measure of effectiveness, based on the two most recent EBCTCG meta-analyses. Actual resource costs were calculated. With a decision analytic model, the incremental cost-effectiveness ratios (1998 versus 1994, and 2001 versus 1998) were calculated. RESULTS: The introduction of the 1998 guideline resulted in a relative increase of 80% in the total number of patients eligible for adjuvant therapy, compared with 1994 (from 40% to 72% of all patients with primary breast cancer). With an estimated absolute increase of 10-year overall survival of 2%, the 1998 guideline was found to have an expected incremental cost-effectiveness ratio of about 4837 per life-year gained. CONCLUSIONS: Introduction of the new guideline considerably affected the number of patients eligible for adjuvant systemic therapy for breast cancer. The associated incremental cost-effectiveness ratio is well within the range of values that are generally considered acceptable.

Adult↗

Impact of the introduction of a guideline on the targeted detection of hereditary haemochromatosis.

BACKGROUND: In 1998 a clinical guideline for the targeted, accurate and early detection and treatment of HFE-related hereditary haemochromatosis (HH), which comprises a test for the causative HFE-gene mutations, was introduced in our outpatient department. METHODS: The impact of this guideline was evaluated retrospectively. Data were acquired from medical records of patients with discharge diagnosis codes suggestive of HH (n=878 patients), obtained from a period before (n=422) and after guideline introduction (n=456). RESULTS: Combined measurements of serum transferrin saturation and serum ferritin rose from 12.2% (n=53) to 29.5% (n=138, p<0.001), leaving 70% of the patients eligible for HH not tested for iron parameters. The HFE-gene mutation detection test was correctly used in II (40.7%) of 27 tested patients and improperly interpreted in six (22.2%) of these 27 patients. Five new HH patients were diagnosed before and 13 after introduction. Seven of these 13 patients appeared to be incorrectly diagnosed, due to misinterpretation of laboratory results. Diagnostic costs of case detection for each accurately diagnosed patient were euro 2380 before and euro 2600 after introduction of the guideline. CONCLUSION: Evaluation of the introduction of a practical guideline for targeted HH detection reveals a low compliance with the guideline, resulting in both a small percentage of patients tested for HH and overdiagnosis of HH. Therefore, the introduction of the guideline should be combined with a more appropriate implementation strategy which includes education on its most critical points, i.e. the indication and interpretation of the iron parameters and the HFE genotype.

Biopsy↗

Ventilation tubes in infants increase the risk of otorrhoea and antibiotic usage.

1) PROBLEM/OBJECTIVE: The effect of ventilation tubes on acute otitis related symptoms (otorrhoea, earache, and fever) and on antibiotic usage was investigated in children with persistent otitis media with effusion, as part of a multicenter, randomised, controlled clinical trial. 2) METHODOLOGY: One hundred-eighty-seven children were randomly placed into either a watchful waiting group (WW group) (n = 94) or a group treated with ventilation tubes (VT group) (n = 93). Both groups were followed for 12 months. Data were collected from parental reports and from medical files kept by the attending ENT-surgeons. 3) RESULTS: There were significant differences in the reported frequency of otorrhoea (but not of earache or fever) between both groups during follow-up, i.e. children in the VT group had more episodes of otorrhoea than the children in the WW group (p < 0.003). As a consequence, children in the VT group had been prescribed antibiotics more often. 4) CONCLUSIONS: Young children treated with ventilation tubes due to persistent otitis media with effusion have a higher risk of developing otorrhoea because of the tubes, and they have a higher risk of needing treatment with antibiotics.

Anti-Bacterial Agents↗

FDG-PET in staging lung cancer: how does it change the algorithm?

BACKGROUND: In patients with lung cancer, positron emission tomography (PET) using fluor-18-fluorodesoxyglucose (FDG) may be used both to detect extrathoracic metastases (ETM) and for mediastinal lymph node staging (MLS), potentially reducing the need for mediastinoscopy. We assessed the added value of FDG-PET in detecting ETM and focused on the reliability of FDG-PET and mediastinoscopy for MLS. PATIENTS AND METHODS: In 72 consecutive patients with non-small cell lung cancer, the impact of adding FDG-PET to full conventional clinical staging was prospectively analyzed. The predictive value of FDG-PET findings and tumor location for pathologic mediastinal lymph node status were assessed in a logistic regression analysis. RESULTS: Unexpected extrathoracic metastases were detected by FDG-PET in 15% of patients. In MLS overall negative and positive predictive values were 71 and 83% for FDG-PET, and 92 and 100% for mediastinoscopy. However, the negative predictive value of FDG-PET was only 17% in case of FDG-PET positive N1 nodes and/or a centrally located primary tumor, whereas it was 96% in case of FDG-PET negative N1 nodes and a non-centrally located primary tumor. CONCLUSION: By incorporating FDG-PET in clinical staging, 15% of patients with lung cancer are upstaged due to unexpected extrathoracic metastases. In case of a negative mediastinal FDG-PET, mediastinoscopy can only be omitted in the presence of a non-centrally located primary tumor and without FDG-PET positive N1 nodes.

Adolescent↗

Cost-effectiveness of cognitive behaviour therapy for patients with chronic fatigue syndrome.

BACKGROUND: There is some evidence that cognitive behaviour therapy (CBT) is efficacious in chronic fatigue syndrome (CFS), but little data on its cost-effectiveness. DESIGN: Prospective economic analysis alongside a randomized clinical trial. METHODS: CFS patients were randomly assigned to CBT, guided support groups (SG), or the 'natural course' (NC, no protocol-based interventions). Patients were treated for 8 months and followed-up for another 6 months. Costs per patient showing clinically significant improvement, based on the CIS fatigue scale, and costs per quality-adjusted life year, were determined for a time period of 14 months. RESULTS: Data were available for 171 patients at 8 months and for 128 at 14 months. At 8 and 14 months, the percentages of improved patients were 31% and 27% for CBT, 9% and 11% for SG, and 12% and 20% for NC. Mean QALYs gained at 14 months were, for CBT, SG and NC, respectively, 0.0737, -0.0018 and 0.0458. CBT and SG mean treatment costs were euro1490 and euro424. Other medical costs for CBT, SG, and NC, respectively, were euro324, euro623 and euro412 for the first period, and euro232, euro561 and euro378 for the second period. Non-medical costs for these periods for CBT, SG and NC were euro262, euro550, euro427 and euro226, euro439, euro287, respectively. Productivity costs were considerable, but not significantly different between groups. DISCUSSION: CBT was less costly and more effective than SG. Compared to NC, the baseline incremental cost-effectiveness of CBT was euro20 516 per CFS patient showing clinically significant improvement, and euro21 375 per QALY. The bootstrap ratios showed considerable uncertainty regarding the results. Future research should focus on productivity costs, and follow patients prospectively over a longer period.

Adolescent↗

Repair of large midline incisional hernias with polypropylene mesh: comparison of three operative techniques.

Polypropylene mesh is widely used for the reconstruction of incisional hernias that cannot be closed primarily. Several techniques have been advocated to implant the mesh. The objective of this study was to evaluate, retrospectively, early and late results of three different techniques, onlay, inlay, and underlay. The records of 53 consecutive patients with a large midline incisional hernia -- 25 women and 28 men, mean age 60.4 (range 28-94) -- were reviewed. Polypropylene mesh was implanted using the onlay technique in 13 patients, inlay in 23 patients, and underlay in 17 patients. Either the greater omentum or a polyglactin mesh was interponated between the mesh and the viscera. The records of these 53 patients were reviewed with respect to: size and cause of the hernia, pre- and postoperative mortality and morbidity, with special attention to wound complications. Patients were invited to attend the outpatient clinic at least 12 months after implantation of the mesh for physical examination of the abdominal wall. Postoperative complications occurred in 14 (26.4%) patients. The onlay technique had significantly more complications, as compared to both other techniques. Reherniation occurred in 15 (28.3%) patients. The reherniation rate of the inlay technique was significantly higher than after the underlay technique (44% vs 12%, P=0.03) and tended to be higher than the onlay technique (44% vs 23%, P=0.22). Repair of large midline incisional hernias with the use of a polypropylene mesh carries a high risk of complications and has a high reherniation rate. The underlay technique seems to be the better technique.

Abdominal Muscles↗

Predicting the need for hospital admission in patients with intentional drug overdose.

BACKGROUND: Self-poisoned patients are often admitted to a medical unit. However, often no treatment is given. We have developed a model to predict those patients who will not be treated and how long patients should be observed before this prediction can be safely made. METHODS: In this retrospective study a model to predict treatment was developed based on cases of self-poisoning in 1996 and validated on cases between 1997 and 1999. In a teaching hospital in The Netherlands 299 adults performing 353 episodes of self-poisoning were studied. The main outcome measures were predicted versus initiated medical treatment, time to prediction and time to initiation of treatment. RESULTS: The model predicted that in 51% (156/307) of all autointoxications no treatment would be given. In 2% (6/307) of all cases, treatment was incorrectly not predicted. All but one of these were preventive treatments based on the ingested compound. 4.5 hours after admission no additional patients fulfilled the criteria for prediction of treatment and all treatments were started within 4.5 hours. CONCLUSIONS: In 51% of patients that present with an autointoxication the model accurately predicts that no treatment will be initiated. This decision can be made in the first 4.5 hours after presentation. This model can be used for a first screening of patients. It can also be used as a basis for a further prospective study to establish rational guidelines in the management of these patients.

Adult↗

Lower urinary tract symptoms: social influence is more important than symptoms in seeking medical care.

OBJECTIVE: To determine associations among lower urinary tract symptoms (LUTS), symptom severity, subjective beliefs and social influences when seeking primary medical care in men aged > or = 50 years. SUBJECTS AND METHODS: A population-based survey was conducted among 5052 men aged > or = 50 years, using patient registers of 22 general practitioners (GPs) in the Netherlands from November 1999 to May 2000. The questionnaire contained items concerning age, educational level, International Prostate Symptom Score (IPSS), bothersome score (BS), and questions from the Health Belief Model on attitude and social influences. The study population comprised men with an IPSS openface> 7. The odds ratios (ORs) corrected for the IPSS were calculated. RESULTS: In all, 3544 questionnaires (70.2%) were returned. Two groups of men with an IPSS openface> 7 were compared: those who consulted their GP in the previous 2 years because of voiding problems (268 cases) and the controls (272) who did not visit a GP for these symptoms. Cases more often thought a physician could improve their condition (OR 2.85), appeared to be more often advised by others to seek medical care (OR 6.36) and thought more often that this advice influenced their decision (OR 13.95). They also had more frequently received information from the media (OR 2.66) which affected their attendance (OR 12.52). In a multiple regression analysis, advice from others or information from the media were stronger predictors of seeking care than the influence of symptoms on daily life, the IPSS or the BS. CONCLUSION: Social influences, i.e. advice from others or the media, were more important factors in the decision to seek medical care than symptom severity.

Aged↗

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↗

Economic evaluation of ventilation tubes in otitis media with effusion.

OBJECTIVE: To determine the costs and effectiveness of treatment with ventilation tubes as compared with watchful waiting in children with persistent otitis media with effusion. DESIGN: Randomized controlled trial. SETTING: Institutional practice. PATIENTS: A total of 187 young children (19 months old) with persistent bilateral otitis media with effusion. INTERVENTIONS: Treatment with ventilation tubes or watchful waiting. MAIN OUTCOME MEASURES: The time without effusion, language development, and the costs from a societal perspective during 1-year follow-up. RESULTS: The mean duration of effusion was 9.2 months in the watchful waiting group and 4.7 months in the ventilation tube group. The language development was comparable in both groups (0.7 month of improvement difference [95% confidence interval, -0.3 to 1.7 months] after correction for confounding variables). Because no statistically significant differences were found in the language development between the treatment groups, we performed a cost minimization analysis. The mean costs per child during 1 year of follow-up were 454 US dollars in the ventilation tube group and 120 US dollars in the watchful waiting group. On average, an additional investment of 334 US dollars per patient was needed for ventilation tube treatment. CONCLUSION: In the absence of differences in language development and in view of higher costs, treatment with ventilation tubes is not recommended as standard treatment in all young children with persistent otitis media with effusion traced by a population-based screening program.

Cost-Benefit Analysis↗

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↗

Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting.

The objective was to study the generalizability of trial results by comparing randomized patients to eligible but nonrandomized patients who received the same management. Implementation of trial results is only justifiable when the results can be generalized to the total domain population. The design was a multicentre randomized controlled trial on the effect of early screening and treatment with ventilation tubes on infants with otitis media with effusion. Randomized (n = 187) and nonrandomized eligible patients (n = 133) were followed up. The study population comprised children who were detected by auditory screening at the age of 9-12 months and who were subsequently diagnosed with persistent bilateral otitis media with effusion for 4-6 months. A significant difference was found in the distribution of some prognostic factors: more randomized children had older siblings, did not attend day care and had mothers with a lower educational level than the nonrandomized children. These factors, however, did not modify the outcome. No differences were found in mean hearing levels between the randomized and nonrandomized children: in both the randomized and nonrandomized children ventilation tubes improved the hearing level, especially after 6 months. However, in the long term (12 months), the hearing levels were equal again. The results of the randomized and nonrandomized patients were comparable. The results of this trial appear to be generalizable to the total domain population. The procedure of following up both randomized and nonrandomized patients is recommended when there is concern about selective participation and reduced generalizability.

Acoustic Impedance Tests↗

Interactive technology assessment and wide reflective equilibrium.

Interactive technology assessment (iTA) provides an answer to the ethical problem of normative bias in evaluation research. This normative bias develops when relevant perspectives on the evaluand (the thing being evaluated) are neglected. In iTA this bias is overcome by incorporating different perspectives into the assessment. As a consequence, justification of decisions based on the assessment is provided by stakeholders having achieved agreement. In this article, agreement is identified with wide reflective equilibrium to show that it indeed has the potential of justifying decisions. We work out several conditions for this agreement to be achievable and just.

Consensus↗

The effect of short-term ventilation tubes versus watchful waiting on hearing in young children with persistent otitis media with effusion: a randomized trial.

OBJECTIVE: To study the effect of short-term ventilation tubes in children aged 1 to 2 yr with screening-detected, bilateral otitis media with effusion (OME) persisting for 4 to 6 mo, as compared with watchful waiting. DESIGN: Multi-center randomized controlled trial (N = 187) with two treatment arms: short-term ventilation tubes versus watchful waiting. Young children underwent auditory screening; those with persistent (4 to 6 mo) bilateral OME were recruited. RESULTS: The mean duration of effusion over 1-yr follow-up was 142 days (36%) in the ventilation tube (VT) group versus 277 days (70%) in the watchful waiting (WW) group. After 6 mo of follow-up, the pure-tone average in the VT group was 5.6 dB A better than that in the WW group. After 12 mo, most of the advantage in the VT group had disappeared. After the insertion of ventilation tubes, the children with poorer hearing levels at randomization improved more than the children with better hearing levels. The largest difference in hearing levels was found between the children in the VT group whose ventilation tubes remained in situ and the children in the WW group. In the VT children with recurrence of OME, the hearing levels again increased, but remained slightly lower than those in the infants with persistent OME in the WW group. CONCLUSIONS: Ventilation tubes have a beneficial effect on hearing in the short run (6 mo); this effect, however, largely disappears in the long run (12 mo). This is probably due to partial recurrent OME in the VT group and to partial spontaneous recovery in the WW group.

Algorithms↗

Using a balancing procedure in multicenter clinical trials. Simulation of patient allocation based on a trial of ventilation tubes for otitis media with effusion in infants.

OBJECTIVE: A basic issue in randomized controlled trials (RCTs) is whether we can safely assume comparability between groups at baseline with respect to all potentially important prognostic factors. In other words, did randomization work sufficiently well? In small trials balanced allocation procedures are employed, whereas in large-scale trials simple randomization will do. The question is: When should balancing be considered? METHODS: We performed a simulation study in which we varied the number of categories in the prognostic factors and the number of patients. RESULTS: Simulation showed that, in all instances, a balancing procedure almost always led to perfect or almost perfect balance, while the imbalance with simple randomization was larger. To study the effect of balanced and random allocation on subgroup analyses in our OME trial, we compared the quotient of the width of the confidence intervals (CI). The widest CI in random allocation over the 13 hospitals was on average 13% wider than in balanced allocation. CONCLUSION: Investigators should always consider balanced allocation, especially in categories with a low number of patients and when subgroup analysis over many categories is requested.

Female↗