15 results on '"Bossuyt, P. M."'
Search Results
2. [Systematic reviews in practice. X. Searching, selecting and the methodological assessment of diagnostic evaluation research].
- Author
-
Devillé WL, Bossuyt PM, de Vet HC, Bezemer PD, Bouter LM, and Assendelft WJ
- Subjects
- Humans, Predictive Value of Tests, Reference Standards, Reproducibility of Results, Sensitivity and Specificity, Diagnostic Tests, Routine standards, MEDLINE standards, Research standards, Review Literature as Topic
- Abstract
Literature concerning the value of diagnostic tests is poorly indexed in electronic bibliographical databases. An extensive, sensitive and specific search strategy for evaluation of a diagnostic test in Medline is a combination of key words or text words concerning the diagnostic test with: 'sensitivity and specificity' (exploded), 'mass screening' (exploded), 'reference values', 'false positive reactions', 'false negative reactions', 'specificit$.tw', 'screening.tw', 'false positive$.tw', 'false negative$.tw', 'accuracy.tw', 'predictive value$.tw', 'reference value$.tw', 'roc$.tw' or 'likelihood ratio$.tw'. Inclusion and exclusion criteria select publications which meet certain minimum requirements, such as the presence of an accepted reference standard, a clear definition of 'diseased', and the presence of a suitable outcome measure. The methodological assessment list should contain a number of validity criteria as well as a number of criteria by which to measure the extent to which the study results can be generalised. Important assessment criteria that may affect the diagnostic value of the test are: study design, blinding, use of different reference standards, the absence of details about the diagnostic criteria for the diagnostic test and insufficient information about the study population.
- Published
- 2002
3. Natural conception rates in couples with unexplained or mild male subfertility scheduled for fertility treatment: a secondary analysis of a randomized controlled trial.
- Author
-
Eekelen, R van, Tjon-Kon-Fat, R I, Bossuyt, P M M, Geloven, N van, Eijkemans, M J C, Bensdorp, A J, Veen, F van der, Mol, B W, Wely, M van, van Eekelen, R, van Geloven, N, van der Veen, F, and van Wely, M
- Subjects
PREGNANCY ,INFERTILITY treatment ,HUMAN fertility ,HUMAN in vitro fertilization ,EMBRYO transfer ,INFERTILITY ,BIRTH rate ,COMPARATIVE studies ,CONCEPTION ,FERTILITY ,FERTILIZATION in vitro ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,EVALUATION research ,SEVERITY of illness index ,DIAGNOSIS - Abstract
Study Question: What is the natural conception rate over the course of 12 months in couples with unexplained or mild male subfertility who are scheduled for fertility treatment and have a predicted unfavourable prognosis for natural conception?Summary Answer: The natural conception rate over the course of 12 months in couples who were allocated to treatment was estimated to be 24.5% (95% CI: 20-29%).What Is Known Already: After starting treatment, couples often perceive unsuccessful cycles as evidence of definitive failure even though they are still able to conceive naturally in between and after treatment. The magnitude of the natural conception rate for couples who chose to commence treatment is unknown, as is whether the calculated prognosis before commencing treatment is still applicable.Study Design, Size, Duration: We performed a secondary analysis of a randomized controlled trial including couples with unexplained or mild male subfertility and an unfavourable prognosis for natural conception. Couples were allocated to either three cycles IVF with single embryo transfer (SET), six cycles of IVF in a modified natural cycle (MNC) or six cycles of IUI with controlled ovarian hyperstimulation (IUI-COH). The detailed data collection in this trial allowed us to study the conception rates in periods that couples were not receiving treatment.Participants/materials, Settings, Methods: We split the dataset into periods during which couples were treated and periods during which they were not treated. Couples could conceive naturally in the periods before, in between and after treatment cycles. The outcome was ongoing pregnancy, thus natural conception rate refers to natural conception leading to ongoing pregnancy. We performed a Cox proportional hazards analysis with female age, duration of subfertility and a time-varying covariate with four categories: IVF-SET, IVF-MNC, IUI-COH and no treatment. We used this Cox model to estimate the natural conception rate over 12 months of no treatment.Main Results and the Role Of Chance: Out of 602 included couples, there were 342 ongoing pregnancies, of which 77 (23%) resulted from natural conception. The estimated natural conception rate over 12 months was 24.5% (95% CI: 20-29%) on cohort level. Estimated rates for female age varying between 18 and 38 years and duration of subfertility between 1 and 3 years ranged from 22 to 35%.Limitations, Reasons For Caution: We considered couples at risk for natural conception when not receiving treatment, whereas they might not have had periovulatory sexual intercourse. As couples were scheduled for treatment, it is possible that these couples were less inclined to try to conceive naturally, potentially leading to an underestimation of their natural conception rate if they kept trying to conceive.Wider Implications Of the Findings: Couples with unexplained subfertility who are about to start fertility treatment, still have about a one in four chance of ongoing pregnancy due to natural conception over 12 months. This information can add to the counselling of couples who commenced fertility treatment after failed cycles and to emphasize not to cease their natural attempts.Study Funding/competing Interest(s): The INeS trial was supported by a grant from ZonMW, the Dutch Organization for Health Research and Development (120620027), and a grant from Zorgverzekeraars Nederland, the Dutch association of health care insurers (09-003). The funders had no role in study design, collection, analysis and interpretation of the data. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck and Guerbet. No other potential conflicts of interest reported.Trial Registration Number: The INeS trial was registered at the Dutch trial registry (NTR 939). [ABSTRACT FROM AUTHOR]- Published
- 2018
- Full Text
- View/download PDF
4. IVF or IUI as first-line treatment in unexplained subfertility: the conundrum of treatment selection markers.
- Author
-
Tjon-Kon-Fat, R. I., Tajik, P., Zafarmand, M. H., Bensdorp, A. J., Bossuyt, P. M. M., Oosterhuis, G. J. E., van Golde, R., Repping, S., Lambers, M. D. A., Slappendel, E., Perquin, D., Pelinck, M. J., Gianotten, J., Maas, J. W. M., Eijkemans, M. J. C., van der Veen, F., Mol, B. W., van Wely, M., and INeS study group†
- Subjects
HUMAN in vitro fertilization ,INFERTILITY treatment ,FOLLICLE-stimulating hormone ,EMBRYO transfer ,BODY mass index ,HUMAN artificial insemination ,BIRTH rate ,COMPARATIVE studies ,CONCEPTION ,FERTILIZATION in vitro ,RESEARCH methodology ,MEDICAL cooperation ,PROGNOSIS ,RESEARCH ,EVALUATION research ,PATIENT selection - Abstract
Study Question: Are there treatment selection markers that could aid in identifying couples, with unexplained or mild male subfertility, who would have better chances of a healthy child with IVF with single embryo transfer (IVF-SET) than with IUI with ovarian stimulation (IUI-OS)?Summary Answer: We did not find any treatment selection markers that were associated with better chances of a healthy child with IVF-SET instead of IUI-OS in couples with unexplained or mild male subfertility.What Is Known Already: A recent trial, comparing IVF-SET to IUI-OS, found no evidence of a difference between live birth rates and multiple pregnancy rates. It was suggested that IUI-OS should remain the first-line treatment instead of IVF-SET in couples with unexplained or mild male subfertility and female age between 18 and 38 years. The question remains whether there are some couples that may have higher pregnancy chances if treated with IVF-SET instead of IUI.Study Design, Size, Duration: We performed our analyses on data from the INeS trial, where couples with unexplained or mild male subfertility and an unfavourable prognosis for natural conception were randomly allocated to IVF-SET, IVF in a modified natural cycle or IUI-OS. In view of the aim of this study, we only used data of the comparison between IVF-SET (201 couples) and IUI-OS (207 couples).Participants/materials, Setting, Methods: We pre-defined the following baseline characteristics as potential treatment selection markers: female age, ethnicity, smoking status, type of subfertility (primary/secondary), duration of subfertility, BMI, pre-wash total motile count and Hunault prediction score. For each potential treatment selection marker, we explored the association with the chances of a healthy child after IVF-SET and IUI-OS and tested if there was an interaction with treatment. Given the exploratory nature of our analysis, we used a P-value of 0.1.Main Results and the Role Of Chance: None of the markers were associated with higher chances of a healthy child from IVF-SET compared to IUI-OS (P-value for interaction >0.10).Limitations, Reasons For Caution: Since this is the first large study that looked at potential treatment selection markers for IVF-SET compared to IUI-OS, we had no data on which to base a power calculation. The sample size was limited, making it difficult to detect any smaller associations.Wider Implications Of the Findings: We could not identify couples with unexplained or mild male subfertility who would have had higher chances of a healthy child from immediate IVF-SET than from IUI-OS. As in the original trial IUI-OS had similar effectiveness and was less costly compared to IVF-SET, IUI-OS should remain the preferred first-line treatment in these couples.Study Funding/competing Interest(s): The study was supported by a grant from the Netherlands Organization for Health Research and Development, and a grant from the Netherlands' association of health care insurers. There are no conflicts of interest.Trial Registration Number: The trial was registered at the Dutch trial registry (NTR939). [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
5. MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial.
- Author
-
Lemmers, M., Verschoor, M. A. C., Rengerink, K. Oude, Naaktgeboren, C., Opmeer, B. C., Bossuyt, P. M., Huirne, J. A. F., Janssen, C. A. H., Radder, C., Klinkert, E. R., Langenveld, J., Catshoek, R., Van der Voet, L., Siemens, F., Geomini, P., Van Hooff, M. H., Van der Ploeg, J. M., Coppus, S. F. P. J., Ankum, W. M., and Mol, B. W. J.
- Subjects
MISCARRIAGE ,MISOPROSTOL ,UTERINE surgery ,FIRST trimester of pregnancy ,PREGNANCY complications ,RANDOMIZED controlled trials ,THERAPEUTICS ,ABORTIFACIENTS ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,EVALUATION research ,TREATMENT effectiveness ,CURETTAGE ,INCOMPLETE miscarriage - Abstract
Study Question: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage?Summary Answer: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.What Is Known Already: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage.Study Design, Size, Duration: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application.Participants/materials, Setting, Methods: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization.Main Results and the Role Of Chance: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy.Limitations, Reasons For Caution: Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely.Wider Implications Of the Findings: In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage.Study Funding/competing Interests: This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests.Trial Registration Number: Dutch Trial Register NTR3310, http://www.trialregister.nl TRIAL REGISTRATION DATE: 27 February 2012.Date Of First Patient's Enrolment: 12 June 2012. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
6. A multivariable model to guide the decision for pessary placement to prevent preterm birth in women with a multiple pregnancy: a secondary analysis of the ProTWIN trial.
- Author
-
Tajik, P., Monfrance, M., van 't Hooft, J., Liem, S. M. S., Schuit, E., Bloemenkamp, K. W. M., Duvekot, J. J., Nij Bijvank, B., Franssen, M. T. M., Oudijk, M. A., Scheepers, H. C. J., Sikkema, J. M., Woiski, M., Mol, B. W. J., Bekedam, D. J., Bossuyt, P. M., and Zafarmand, M. H.
- Subjects
MULTIPLE pregnancy ,PERINATAL death ,PERINATAL care ,PREGNANCY ,MULTIPLE birth ,CERVIX uteri ,COMPARATIVE studies ,DECISION making ,FETAL ultrasonic imaging ,PREMATURE infants ,RESEARCH methodology ,MEDICAL cooperation ,MULTIVARIATE analysis ,PESSARIES ,PRENATAL care ,RESEARCH ,RESEARCH evaluation ,EVALUATION research ,RANDOMIZED controlled trials ,PREVENTION - Abstract
Objective: The ProTWIN Trial (NTR1858) showed that, in women with a multiple pregnancy and a cervical length < 25(th) percentile (38 mm), prophylactic use of a cervical pessary reduced the risk of adverse perinatal outcome. We investigated whether other maternal or pregnancy characteristics collected at baseline can improve identification of women most likely to benefit from pessary placement.Methods: ProTWIN is a multicenter randomized trial in which 808 women with a multiple pregnancy were assigned to pessary or control. Using these data we developed a multivariable logistic model comprising treatment, cervical length, chorionicity, pregnancy history and number of fetuses, and the interaction of these variables with treatment as predictors of adverse perinatal outcome.Results: Short cervix, monochorionicity and nulliparity were predictive factors for a benefit from pessary insertion. History of previous preterm birth and triplet pregnancy were predictive factors of possible harm from pessary. The model identified 35% of women as benefiting (95% CI, 32-39%), which is 10% more than using cervical length only (25%) for pessary decisions. The model had acceptable calibration. We estimated that using the model to guide the choice of pessary placement would reduce the risk of adverse perinatal outcome significantly from 13.5% when no pessary is inserted to 8.1% (absolute risk reduction, 5.4% (95% CI, 2.1-8.6%)).Conclusions: We developed and internally validated a multivariable treatment selection model, with cervical length, chorionicity, pregnancy history and number of fetuses. If externally validated, it could be used to identify women with a twin pregnancy who would benefit from a pessary, and lead to a reduction in adverse perinatal outcomes in these women. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
7. Is IVF-served two different ways-more cost-effective than IUI with controlled ovarian hyperstimulation?
- Author
-
Tjon-Kon-Fat, R. I., Bensdorp, A. J., Bossuyt, P. M. M., Koks, C., Oosterhuis, G. J. E., Hoek, A., Hompes, P., Broekmans, F. J., Verhoeve, H. R., de Bruin, J. P., van Golde, R., Repping, S., Cohlen, B. J., Lambers, M. D. A., van Bommel, P. F., Slappendel, E., Perquin, D., Smeenk, J., Pelinck, M. J., and Gianotten, J.
- Subjects
COST effectiveness ,INDUCED ovulation ,HUMAN in vitro fertilization ,HUMAN artificial insemination ,EMBRYO transfer ,MEDICAL care costs ,INFERTILITY treatment ,BIRTH rate ,COMPARATIVE studies ,CONCEPTION ,CRYOPRESERVATION of organs, tissues, etc. ,FERTILIZATION in vitro ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,PROGNOSIS ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,STATISTICAL models ,ECONOMICS - Abstract
Study Question: What is the cost-effectiveness of in vitro fertilization (IVF) with conventional ovarian stimulation, single embryo transfer (SET) and subsequent cryocycles or IVF in a modified natural cycle (MNC) compared with intrauterine insemination with controlled ovarian hyperstimulation (IUI-COH) as a first-line treatment in couples with unexplained subfertility and an unfavourable prognosis on natural conception?.Summary Answer: Both IVF strategies are significantly more expensive when compared with IUI-COH, without being significantly more effective. In the comparison between IVF-MNC and IUI-COH, the latter is the dominant strategy. Whether IVF-SET is cost-effective depends on society's willingness to pay for an additional healthy child.What Is Known Already: IUI-COH and IVF, either after conventional ovarian stimulation or in a MNC, are used as first-line treatments for couples with unexplained or mild male subfertility. As IUI-COH is less invasive, this treatment is usually offered before proceeding to IVF. Yet, as conventional IVF with SET may lead to higher pregnancy rates in fewer cycles for a lower multiple pregnancy rate, some have argued to start with IVF instead of IUI-COH. In addition, IVF in the MNC is considered to be a more patient friendly and less costly form of IVF.Study Design, Size, Duration: We performed a cost-effectiveness analysis alongside a randomized noninferiority trial. Between January 2009 and February 2012, 602 couples with unexplained infertility and a poor prognosis on natural conception were allocated to three cycles of IVF-SET including frozen embryo transfers, six cycles of IVF-MNC or six cycles of IUI-COH. These couples were followed until 12 months after randomization.Participants/materials, Setting, Methods: We collected data on resource use related to treatment, medication and pregnancy from the case report forms. We calculated unit costs from various sources. For each of the three strategies, we calculated the mean costs and effectiveness. Incremental cost-effectiveness ratios (ICER) were calculated for IVF-SET compared with IUI-COH and for IVF-MNC compared with IUI-COH. Nonparametric bootstrap resampling was used to investigate the effect of uncertainty in our estimates.Main Results and the Role Of Chance: There were 104 healthy children (52%) born in the IVF-SET group, 83 (43%) the IVF-MNC group and 97 (47%) in the IUI-COH group. The mean costs per couple were €7187 for IVF-SET, €8206 for IVF-MNC and €5070 for IUI-COH. Compared with IUI-COH, the costs for IVF-SET and IVF-MNC were significantly higher (mean differences €2117; 95% CI: €1544-€2657 and €3136, 95% CI: €2519-€3754, respectively).The ICER for IVF-SET compared with IUI-COH was €43 375 for the birth of an additional healthy child. In the comparison of IVF-MNC to IUI-COH, the latter was the dominant strategy, i.e. more effective at lower costs.Limitations, Reasons For Caution: We only report on direct health care costs. The present analysis is limited to 12 months.Wider Implications Of the Findings: Since we found no evidence in support of offering IVF as a first-line strategy in couples with unexplained and mild subfertility, IUI-COH should remain the treatment of first choice.Study Funding/competing Interests: The study was supported by a grant from ZonMw, the Netherlands Organization for Health Research and Development, (120620027) and a grant from Zorgverzekeraars Nederland, the Netherlands' association of health care insurers (09-003).Trial Registration Number: Current Controlled Trials ISRCTN52843371; Nederlands Trial Register NTR939. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
8. Development and validation of a short questionnaire in community acquired pneumonia.
- Author
-
El# Moussaoui, R., Opmeer, B. C., Bossuyt, P. M. M., Speelman, P., De Borgie, C. A. J. M., and Prins, J. M.
- Subjects
LUNG diseases ,DYSPNEA ,FATIGUE (Physiology) ,PHYSIOLOGY ,PSYCHOMETRICS ,PATIENTS ,PNEUMONIA diagnosis ,CLINICAL trials ,COMPARATIVE studies ,COUGH ,HEALTH status indicators ,RESEARCH methodology ,MEDICAL cooperation ,PHYSICAL fitness ,RESEARCH ,SPUTUM ,EVALUATION research ,RANDOMIZED controlled trials ,COMMUNITY-acquired infections ,BLIND experiment - Abstract
Background: A short but sensitive questionnaire evaluating changes in respiratory symptoms and well being during the treatment of community acquired pneumonia (CAP) is needed. We have developed a measurement and evaluated its psychometric properties in 67 patients admitted with CAP.Methods: The patients were asked to indicate the presence and severity of dyspnoea, coughing, coughing up sputum, coughing up sputum with ease, the colour of the sputum, fatigue, fitness, and their state of health. The item fatigue showed substantial overlap with fitness and was therefore excluded. The response of the patients to the remaining eight items was used to calculate a CAP score.Results: The percentage of missing data (0.2-1.7%), floor and ceiling effects (0.2/5.5%), internal consistency (Cronbach alpha = 0.87), and the intraclass correlation coefficient for test-retest reproducibility (0.83) met predefined criteria, indicating good acceptability and reliability. Face and clinical validity were satisfactory. Effect sizes under treatment were large, indicating high responsiveness.Conclusion: The newly developed CAP score is a simple, reliable, valid, and highly responsive instrument. This makes it scientifically sound and clinically relevant for measuring outcome when evaluating treatment strategies in CAP. [ABSTRACT FROM AUTHOR]- Published
- 2004
- Full Text
- View/download PDF
9. Toward complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.
- Author
-
Bossuyt, Patrick M., Reitsma, Johannes B., Bruns, David E., Gatsonis, Constantine A., Glasziou, Paul P., Irwig, Les M., Lijmer, Jeroen G., Moher, David, Rennie, Drummond, de Vet, Henrica C.W., for the STARD Group, and STARD Group
- Subjects
DIAGNOSIS ,RADIOLOGY ,RADIOLOGISTS ,RESEARCH - Abstract
: Rationale and ObjectivesTo comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, and analysis of such studies. The authors sought to develop guidelines for improving the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers better to assess the validity and generalizability of study results.: Materials and MethodsThe Standards for Reporting of Diagnostic Accuracy group steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and to extract potential guidelines for authors and editors. An extensive list of items was prepared. Members of the steering committee then met for 2 days with other researchers, editors, methodologists, statisticians, and members of professional organizations to develop a checklist and a prototypical flowchart to guide authors and editors of studies of diagnostic accuracy.: ResultsThe search for published guidelines on diagnostic research yielded 33 previously published checklists, from which the group produced an initial list of 75 items. This list was honed to 25 key items by group consensus and on the basis of published research on bias. A prototypical flowchart was developed as a tool for conveying information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference test, or both. Potential users reviewed the conference version of the checklist and flowchart and provided additional suggestions, which were then incorporated.: ConclusionUse of these carefully developed, consensus-based guidelines should enable clearer and more complete reporting of studies of diagnostic accuracy, as well as better reader understanding of the validity and generalizability of study results. [Copyright &y& Elsevier]
- Published
- 2003
- Full Text
- View/download PDF
10. Treatment of tubal pregnancy in the netherlands: an economic comparison of systemic methotrexate administration and laparoscopic salpingostomy.
- Author
-
Mol, Ben W.J., Hajenius, Petra J., Mol, B W, Hajenius, P J, Engelsbel, S, Ankum, W M, Hemrika, D J, Van der Veen, F, and Bossuyt, P M
- Subjects
TUBAL pregnancy ,METHOTREXATE ,PREGNANCY complications ,LAPAROSCOPY ,CHORIONIC gonadotropins ,CLINICAL trials ,COMPARATIVE studies ,ECTOPIC pregnancy ,GYNECOLOGIC surgery ,GESTATIONAL age ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL care costs ,MEDICAL cooperation ,RESEARCH ,EVALUATION research ,ECONOMICS - Abstract
Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic salpingostomy for the treatment of patients with tubal pregnancy.Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1.Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was <1500 IU/L, a cutoff value that had not been previously hypothesized. In a scenario without a confirmatory laparoscopy, in which transvaginal ultrasonography and serial repeated serum human chorionic gonadotropin measurements were assumed to be as accurate as laparoscopy, systemic methotrexate therapy would have reduced total cost by $1500 for a patient with an initial serum human chorionic gonadotropin concentration of <1500 IU/L. In such a scenario total costs would have been similar for a patient with an initial serum human chorionic gonadotropin concentration in the range of 1500 to 3000 IU/L, whereas systemic methotrexate administration would be more costly for a patient with an initial serum human chorionic gonadotropin concentration of >3000 IU/L.Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. [ABSTRACT FROM AUTHOR]- Published
- 1999
- Full Text
- View/download PDF
11. Comparison of hysterosalpingography and laparoscopy in predicting fertility outcome.
- Author
-
Mol, B W, Collins, J A, Burrows, E A, van der Veen, F, and Bossuyt, P M
- Subjects
COMPARATIVE studies ,FERTILITY ,HYSTEROSALPINGOGRAPHY ,LAPAROSCOPY ,LONGITUDINAL method ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,PROGNOSIS ,RESEARCH ,EVALUATION research - Abstract
In this study, we compare the prognostic significance of hysterosalpingography (HSG) and laparoscopy for fertility outcome. In a prospective cohort study in 11 clinics participating in the Canadian Infertility Treatment Evaluation Study (CITES), consecutive couples who registered between 1 April 1984 and 31 March 1987 for the evaluation of subfertility and who underwent HSG and laparoscopy were included. Unilateral and bilateral tubal occlusion at HSG and laparoscopy were related to treatment-independent pregnancy. Cox regression was used to calculate fecundity rate ratios (FRR). Of the 794 patients who were included, 114 (14%) showed one-sided tubal occlusion and 194 (24%) showed two-sided tubal occlusion on HSG. At laparoscopy, 94 (12%) showed one-sided tubal occlusion and 96 (12%) showed two-sided tubal occlusion. Occlusion detected on HSG and laparoscopy showed a moderate agreement beyond chance (weighted kappa-statistic 0.42). The adjusted FRR of one-sided tubal occlusion at HSG was 0.80, whereas two-sided tubal occlusion showed an FRR of 0.49. For laparoscopy, the FRR were 0.51 and 0.15 respectively. After a normal or one-sided occluded HSG, laparoscopy showed two-sided occlusion in 5% of the patients, and fertility prospects in these patients were virtually zero. If two-sided tubal occlusion was detected on HSG but not during laparoscopy, fertility prospects were slightly impaired. Fertility prospects after a two-sided occluded HSG were strongly impaired in cases where laparoscopy showed one-sided and two-sided occlusion, with FRR of 0.38 and 0.19 respectively. Although laparoscopy performed better than HSG as a predictor of future fertility, it should not be considered as the perfect test in the diagnosis of tubal pathology. For clinical practice, laparoscopy can be delayed after normal HSG for at least 10 months, since the probability that laparoscopy will show tubal occlusion after a normal HSG is very low. [ABSTRACT FROM AUTHOR]
- Published
- 1999
12. Early switch from intravenous to oral antibiotics: guidelines and implementation in a large teaching hospital.
- Author
-
Sevinç, F, Prins, J M, Koopmans, R P, Langendijk, P N, Bossuyt, P M, Dankert, J, and Speelman, P
- Subjects
ACADEMIC medical centers ,ANTIBIOTICS ,COMPARATIVE studies ,INFECTION ,INTERNAL medicine ,INTRAVENOUS therapy ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,ORAL drug administration ,RESEARCH ,OPERATIVE surgery ,TIME ,COST analysis ,EVALUATION research - Abstract
In recent years 'switch therapy' has been advocated: short intravenous antibiotic therapy, for 2-3 days, followed by oral treatment for the remainder of the course. Little is known about the number of patients that could benefit from early switch therapy and the consequences of introducing this strategy in everyday practice. We prospectively registered all antibiotic courses on wards for Internal Medicine, Surgery, and Pulmonology during a 2 month period, before (n = 362, inventorial phase) and after (n = 281, implementation phase) the introduction of guidelines for switching therapy. Approximately 40% of all patients who started on iv antibiotics were candidates for an early iv-oral switch. During the inventorial phase, 54% (52/97) of eligible patients were switched to oral treatment, after a median of 6 days (range 2-28 days). After implementation of the guidelines, this percentage rose to 83% (66/80) (difference 29%, 95% CI 16-42%; P < 0.001). Therapy was also switched earlier, after a median of 4 days (range 2 to 16 days). In the 6 weeks after completion of the oral course, recurrence of infections, or readmissions due to reinfections did not occur. Compared with the inventorial phase, 43% of iv administrations could be avoided, that is >6000 per year. This means a potential annual reduction of dfl.60,000 (c. US$30,000) of administration costs. The potential savings in purchase costs of the antibiotics were dfl.54,000 (US$27,000) annually. In conclusion, a substantial number of patients starting on iv antibiotics were candidates for an early iv-oral switch. The guidelines were well accepted by the physicians and substantial savings in costs and nursing time were achieved. [ABSTRACT FROM AUTHOR]
- Published
- 1999
- Full Text
- View/download PDF
13. Clearance curves of serum human chorionic gonadotrophin for the diagnosis of persistent trophoblast.
- Author
-
Hajenius, P J, Mol, B W, Ankum, W M, van der Veen, F, Bossuyt, P M, and Lammes, F B
- Subjects
FALLOPIAN tube surgery ,BLASTOCYST ,CHORIONIC gonadotropins ,COMPARATIVE studies ,ECTOPIC pregnancy ,GYNECOLOGIC surgery ,LAPAROSCOPY ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,EVALUATION research ,RETROSPECTIVE studies ,IMPACT of Event Scale ,DISEASE complications - Abstract
A well recognized hazard of conservative surgical treatment of tubal pregnancy is incomplete removal of trophoblastic tissue. Persistent trophoblast can be detected by postoperative serum human chorionic gonadotrophin (HCG) monitoring. The impact of various surgical techniques on the post-operative clearance of serum HCG was investigated in a retrospective study. The medical records of 97 patients treated surgically for tubal pregnancy in the Academic Medical Center of the University of Amsterdam, The Netherlands, between 1 January 1992 and 1 August 1994 were reviewed; 28 patients were treated by salpingostomy by laparoscopy, 16 by salpingostomy by open surgery and 53 by salpingectomy by either method. There was no difference in the post-operative clearance of serum HCG after successful conservative surgery compared to radical surgery. However, persistent trophoblast occurred in eight patients (29%) after laparoscopic salpingostomy and in only one patient (6.3%) who had a salpingostomy by open surgery (relative risk 4.57). Serum HCG clearance curves allow early identification of patients with persistent trophoblast after conservative surgical treatment. Moreover, monitoring of post-operative serum HCG until it becomes undetectable is mandatory in order to reveal late-onset types of persistent trophoblast. [ABSTRACT FROM AUTHOR]
- Published
- 1995
14. Meningococcal disease: a comparison of eight severity scores in 125 children.
- Author
-
Derkx, H., Hoek, J., Redekop, W., Bijlmer, R., Deventer, S., Bossuyt, P., Derkx, H H, van den Hoek, J, Redekop, W K, Bijlmer, R P, van Deventer, S J, and Bossuyt, P M
- Subjects
ANALYSIS of variance ,COMPARATIVE studies ,DISCRIMINANT analysis ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,NEISSERIA meningitidis ,PROGNOSIS ,RESEARCH ,RESEARCH evaluation ,SURVIVAL analysis (Biometry) ,EVALUATION research ,RETROSPECTIVE studies ,SEVERITY of illness index ,HOSPITAL mortality - Abstract
Objective: To investigate the accuracy of eight different prognostic scores (Stiehm, Niklasson, Leclerc, Garlund, the MOC score, Tesero, the Glasgow Meningococcal Septicaemia Prognostic Score (GMSPS) and Tüyzüs) in the prediction of fatal outcome in meningococcal disease.Design: Combined prospective and retrospective study.Setting: A 175-bed pediatric department of a university hospital providing secondary care to +/- 180,000 inhabitants and serving as a referral center. The Pediatric Intensive Care (14 beds) is one of the six PICUs in the Netherlands and provides tertiary care for children under 18 years.Patients: During an 8-year period (1986-1994) 125 children (mean age 4 years, 10 months) with culture-proven meningococcal disease were studied: 34 patients presenting with meningitis, 33 patients with septic shock and 58 patients with meningitis and septic shock.Main Results: All eight scores discriminated above average between survivors and non-survivors, as expressed by the corresponding Receiver Operator Characteristic (ROC) curves. The area under the ROC curve (AUC) ranged from 0.74 for the Garlund score to 0.93 for the GMSPS. The GMSPS performed significantly better than its competitors, even after exclusion of the base deficit as one of the score components (AUC = 0.92). It showed above average calibration when logistically transformed into a probability of mortality, and accurately identified a subgroup of patients with no mortality. None of the scores correctly identified non-survivors.Conclusion: The GMSPS is a simple score that can be reliably used for risk classification and the identification of low-risk patients. [ABSTRACT FROM AUTHOR]- Published
- 1996
- Full Text
- View/download PDF
15. Fertility outcome after systemic methotrexate and laparoscopic salpingostomy for tubal pregnancy.
- Author
-
Dias Pereira, G., Hajenius, P.J., Mol, B.W.J., Ankum, W.M., Hemrika, D.J., Bossuyt, P.M.M., Van der Veen, F., Mol, B W, and Bossuyt, P M
- Subjects
- *
ECTOPIC pregnancy , *METHOTREXATE , *LAPAROSCOPIC surgery , *TUBAL pregnancy , *DRUG efficacy , *ABORTIFACIENTS , *CLINICAL trials , *COMPARATIVE studies , *FERTILITY , *GYNECOLOGIC surgery , *LAPAROSCOPY , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *RANDOMIZED controlled trials , *THERAPEUTICS - Abstract
Presents research that compares systemic multi-dose intramuscular methotrexate with laparoscopic salpingostomy in tubal pregnancy. Treatments for tubal pregnancy in women who desire future fertility; Methods; Fertility assessment; Risks for spontaneous intrauterine pregnancy and spontaneous repeat ectopic pregnancy; No large positive effect on future fertility with systemic methotrexate; Methotrexate not being superior to laparoscopy.
- Published
- 1999
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.