Fertility outcome after systemic methotrexate and laparoscopic salpingostomy for tubal pregnancy.
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Abortifacient Agents, Nonsteroidal↗
Biomedical subjects
P M Bossuyt
Publications and source records attributed to P M Bossuyt.
Should patients who are suspected of having an ectopic pregnancy undergo physical examination?
OBJECTIVE: To determine whether physical examination is useful for patients with suspected ectopic pregnancy (EP) for whom transvaginal sonography is performed and serum hCG levels are measured. DESIGN: Prospective study. SETTING: Two large teaching hospitals. PATIENT(S): Three hundred eighty-two patients with suspected EP, based on a positive urine pregnancy test and the presence of abdominal pain, vaginal bleeding, or risk indicators. INTERVENTION(S): Abdominal examination, speculum inspection, and digital vaginal examination. MAIN OUTCOME MEASURE: A final diagnosis made by transvaginal sonography, serum hCG measurement, and, if necessary, confirmatory laparoscopy. RESULT(S): One hundred sixteen (30%) of the 382 patients had an EP. At external abdominal examination, rebound tenderness and muscular rigidity had likelihood ratios of 3.7 and 8.0, respectively. Findings at speculum inspection and digital vaginal examination had likelihood ratios between 0.33 and 2.4. Logistic regression analysis showed that the additional information provided by physical examination for the diagnosis of EP is limited compared with the information provided by transvaginal sonography and serum hCG measurement alone. CONCLUSION: On the basis of our results, we believe that vaginal digital examination for patients with suspected EP is unnecessary.
Adult↗
Can noninvasive diagnostic tools predict tubal rupture or active bleeding in patients with tubal pregnancy?
OBJECTIVE: To evaluate the ability of noninvasive diagnostic tools to predict tubal rupture and active bleeding in patients with tubal pregnancy. DESIGN: Prospective cohort study. SETTING: Two large teaching hospitals in Amsterdam, The Netherlands. PATIENT(S): Consecutively seen patients with suspected tubal pregnancy who were scheduled to undergo confirmative laparoscopy. MAIN OUTCOME MEASURE(S): Tubal rupture and/or active bleeding confirmed at laparoscopy. RESULT(S): Sixty-five (23%) of 288 patients had tubal rupture and/or active bleeding at laparoscopy. Abdominal pain, rebound tenderness on abdominal examination, fluid in the pouch of Douglas at transvaginal ultrasound examination, and a low serum hemoglobin level were independent predictors of tubal rupture and/or active bleeding. Pregnancy achieved with the use of IVF-ET and the presence of an ectopic gestational sac or an ectopic mass at ultrasound examination reduced the risk of tubal rupture. Abdominal pain was the most sensitive predictor, with a sensitivity of 95%. CONCLUSION(S): Because the nonsurgical management of tubal pregnancy should be used only when the risk of tubal rupture and/or active bleeding is low, it can be safely applied in only a limited number of patients.
Adult↗
Traditional health outcomes in the evaluation of diagnostic tests.
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Clinical Trials, Phase II as Topic↗
A simple test of copying ability and sex define survival in patients with early Alzheimer's disease.
BACKGROUND: We studied whether heterogeneous profiles of cognitive function are relevant to survival in patients with early Alzheimer's disease. METHODS: CAMCOG subscales of cognitive function were used as predictors of survival, together with gender in 157 consecutively referred patients with early Alzheimer's disease. Statistical analysis was performed with Cox proportional hazards analysis and Kaplan-Meier survival curves. Survival rates were compared with those in the general population. RESULTS: Eighty patients (51%) died during the follow-up that extended to 5.7 years, with a median survival of 4.4 years after entry. Only the praxis subscore was statistically significant related to survival (P < 0.0001). Its predictive power was based on only two items, including copying ability for a spiral and a three-dimensional house, independent of age, sex, education, overall CAMCOG score, dementia severity and symptom duration. Kaplan-Meier curves for the combined score of these items (0, 1, or 2) showed three groups with significantly different survival rates for both men and women. Comparison of gender specific survival rates with data from the general population showed that excess mortality was statistically significant (P < 0.01) higher in men (51%) than in women (21%) after follow-up extending to 5 years. CONCLUSIONS: A simple test of copying ability defines subgroups of AD patients with large differences in survival rates. This suggests that parietal lobe impairment is an important predictor of mortality in AD. Also, the course of AD may be more benign in women than in men.
Age Distribution↗
Comparison of hysterosalpingography and laparoscopy in predicting fertility outcome.
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.
Adult↗
Early switch from intravenous to oral antibiotics: guidelines and implementation in a large teaching hospital.
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.
Administration, Oral↗
[Roaming through methodology. X. The testing of diagnostic procedures].
In this era of evidence-based medicine, diagnostic tests cannot escape close scrutiny of their effectiveness. Sensitivity and specificity have up till now played a central role in the evaluation of diagnostic tests. These terms are not without their shortcomings when it comes to the characterisation of a test's true worth for patients. Randomised clinical trials are increasingly used for evaluation of medical tests and outlining of strategy. The indirect relationship between test results and health outcome creates additional challenges for designers of such trials.
Diagnostic Techniques and Procedures↗
[The family practitioner and the postcoital test].
There is still a great deal of controversy on the value of the postcoital test. Some consider it to be a valuable method for the general practitioner to evaluate the interaction in vivo between spermatozoa and cervical mucus, in spite of the poor predictive value of the test. The postcoital test is in fact only an indirect method for the detection of the production of moving sperms. As a negative postcoital test is frequently due to bad timing of the test, multiple mandatory intercourse is often necessary, which may lead to frustration and sexual dysfunction. Moreover, there are no indications that the postcoital test with its poor discriminatory power may be better in general practice than the fertility evaluations by a specialist as standardisation and reproducibility problems are equal in both settings. Therefore semen analysis appears to be a better option, for the general practitioner as well.
Family Practice↗
Effect of the timing of treatment of port-wine stains with the flash-lamp-pumped pulsed-dye laser.
BACKGROUND: Port-wine stains can be treated with a flash-lamp-pumped pulsed-dye laser, but it is uncertain whether this treatment is more effective if administered early in life, when the skin is thinner and the lesion is smaller. METHODS: We prospectively studied 100 patients with a previously untreated port-wine stain of the head or neck. They were treated with the flash-lamp-pumped pulsed-dye laser and divided into four age groups (0 to 5, 6 to 11, 12 to 17, and 18 to 31 years). The outcome measure was lightening of the port-wine stain (reduction in the difference in color between the skin with the stain and contralateral healthy skin) as measured with a colorimeter after an average of five treatments (range, three to seven) of the entire lesion. RESULTS: Of the 100 patients, 11 could not be included in the analysis because they had received fewer than three or more than seven treatments, had an erroneous base-line color measurement, or were lost to follow-up. The sizes, locations, and colors of the port-wine stains were similar among the groups. When all 89 patients were analyzed together, the average reduction in the difference in color between the skin with the port-wine stain and contralateral healthy skin was 40 percent. The differences between age groups in the average reduction in color differences were not significant (P= 0.26). By the end of the study, only 7 of 89 patients had completed laser therapy, and in no case was clearance complete. Treatment was discontinued in all seven because the last three treatments did not lead to further lightening. CONCLUSIONS: We found no evidence that treatment of port-wine stains with the flash-lamp-pumped pulsed-dye laser in early childhood is more effective than treatment at a later age.
Adolescent↗
Nonsurgical repigmentation therapies in vitiligo. Meta-analysis of the literature.
OBJECTIVE: To assess the effectiveness and safety of nonsurgical repigmentation therapies in localized and generalized vitiligo by means of a meta-analysis. DATA SOURCES: Computerized searches of bibliographic databases, a complementary manual literature search, and contacts with researchers and pharmaceutical firms. STUDY SELECTION: Predefined selection criteria were applied to both randomized and nonrandomized controlled trials. DATA EXTRACTION: Two investigators independently assessed the articles for inclusion. When there was a disagreement, a third investigator was consulted. DATA SYNTHESIS: Sixty-three studies were found on therapies for localized vitiligo. Of these, 10 of 11 randomized controlled trials and 29 of 110 patient series were included. One hundred seventeen studies on therapies for generalized vitiligo were found. Of these, 10 of 22 randomized controlled trials and 46 of 231 patient series were included. Among randomized controlled trials on localized vitiligo, the pooled odds ratio vs placebo was significant for topical class 3 corticosteroids (14.32; 95% confidence interval [CI], 2.45-83.72). In the patient series, topical class 3 and class 4 corticosteroids carried the highest mean success rates (56% [95% CI, 50%-62%] and 55% [95% CI, 49%-61%], respectively). Side effects were reported mostly with topical psoralen and intralesional and class 4 corticosteroids. In the randomized controlled trials on generalized vitiligo, the odds ratio vs placebo was significant for oral methoxsalen plus sunlight (23.37; 95% CI, 1.33-409.93), oral psoralen plus sunlight (19.87; 95% CI, 2.37-166.32), and oral trioxsalen plus sunlight (3.75; 95% CI, 1.24-11.29). In the series, the highest mean success rates were achieved with narrowband UV-B (63%; 95% CI, 50%-76%), broadband UV-B (57%; 95% CI, 29%-82%), and oral methoxsalen plus UV-A therapy (51%; 95% CI, 46%-56%). Oral methoxsalen plus UV-A was associated with the highest rates of side effects. No side effects were reported with UV-B therapy. CONCLUSIONS: Class 3 corticosteroids and UV-B therapy are the most effective and safest therapies for localized and for generalized vitiligo, respectively.
Humans↗
A systematic review of autologous transplantation methods in vitiligo.
OBJECTIVE: A systematic review of the effectiveness, safety, and applicability of autologous transplantation methods in vitiligo. DATA SOURCES: Computerized searches of bibliographical databases, a complementary manual literature search, and contacts with researchers and pharmaceutical firms. STUDY SELECTION: Predefined selection criteria were applied to all studies found. DATA EXTRACTION: Two investigators independently assessed the articles for inclusion. When there was a disagreement, a third investigator was consulted. DATA SYNTHESIS: Sixty-three studies were found, of which 16 reported on minigrafting, 13 on split-thickness grafting, 15 on grafting of epidermal blisters, 17 on grafting of cultured melanocytes, and 2 on grafting of noncultured epidermal suspension. Of these, 39 patient series were included. The highest mean success rates (87%) were achieved with split-skin grafting (95% confidence interval, 82%-91%), and epidermal blister grafting (87%) (95% confidence interval, 83%-90%). The mean success rate of 5 culturing techniques varied from 13% to 53%. However, in 4 of the 5 culturing methods, fewer than 20 patients were studied. Minigrafting had the highest rates of adverse effects but was the easiest, fastest, and least expensive method. CONCLUSIONS: Because no controlled trials were included, treatment recommendations should be formulated with caution. Split-thickness and epidermal blister grafting can be recommended as the most effective and safest techniques. No definite conclusions can be drawn about the effectiveness of culturing techniques because only a small number of patients have been studied. The choice of method also depends on certain disease characteristics and the availability of specialized personnel and equipment.
Humans↗
The effectiveness of a history-based diagnostic approach in chronic urticaria and angioedema.
OBJECTIVE: To assess the value of extensive laboratory screening for the identification of causes in patients with chronic urticaria and/or angioedema. DESIGN: In a prospective study involving 220 patients, 2 diagnostic strategies were compared: the combination of detailed history taking and limited laboratory investigations vs detailed history taking and extensive laboratory screening. The results of the extensive screening program were initially kept secret from the patients and the physicians. Later, all results were disclosed, and an investigation was undertaken to find out whether this information changed the initial diagnosis. The patients were followed up for 1 year to evaluate the results of interventions and to detect latent causes. SETTING: The study was performed in the outpatient department of a secondary and tertiary care center with institutional practice. PATIENTS: A total of 238 consecutive new patients with chronic urticaria and/or angioedema edema were referred; 18 of them refused participation. One patient was unavailable for follow-up. MAIN OUTCOME MEASURE: The difference in the number of identified causes between both approaches and the nature of the causes that would have been missed by omitting extensive laboratory screening. RESULTS: With a questionnaire and the limited laboratory tests, a cause was found in 45.9% of the patients, compared with 52.7% with the questionnaire and the extended screening program. Except for one parasitic infection, missed diagnoses were mainly adverse reactions to drugs or food detected by standard elimination procedures, not by laboratory investigations. CONCLUSION: Routine laboratory screening did not contribute substantially to the diagnosis of chronic urticaria or to the detection of underlying disorders.
Adolescent↗
The development of practice guidelines for the treatment of severe plaque form psoriasis.
OBJECTIVE: To develop and introduce evidence-based guidelines for the selection of 5 commonly used treatment modalities--UV-B, photochemotherapy, methotrexate, acitretin, and cyclosporine--for adult patients with severe plaque form psoriasis. PATIENTS AND SETTING: Patients, residents, and dermatologists from the Department of Dermatology of the Academic Medical Center of the University of Amsterdam, Amsterdam, the Netherlands, were involved in this process. DESIGN: The development process started with a questionnaire to evaluate how patients with severe psoriasis were treated. A systematic literature review was set up to provide evidence-based estimates of effectiveness, adverse effects, and dropout rates. In 2 meetings, the opinion leaders and intended users discussed the results of the questionnaire and systematic review as well as the clinical considerations in the treatment choices. Guidelines were then made regarding the sequence of selection of 5 modalities in the concept of rotational therapy. These guidelines were introduced. Their use was analyzed for 6 months. RESULTS: Before the guidelines, there was no uniform approach. In the systematic review, 665 studies concerning the treatments were found. Exclusion rates were high. No studies of methotrexate therapy could be included. Photochemotherapy showed the highest average proportion of patients with clearance (70% [6947/9925]) and good response (83% [8238/9925]), followed by UV-B (67.9% [620/913]) and cyclosporine (64% [1030/1609]) therapy. In the second internal meeting, the following sequence for the treatments was defined: UV-B, photochemotherapy, methotrexate, acitretin, and cyclosporine. In 78% (69/88) of patients treated after the introduction, the guidelines were followed to determine the treatment choice. CONCLUSIONS: Guidelines for treating severe plaque form psoriasis can be successfully developed, introduced, and implemented and were considered to improve clinical care.
Evidence-Based Medicine↗
Value of arthrography after supination trauma of the ankle.
OBJECTIVE: To investigate the merits of arthrography after supination trauma of the ankle. DESIGN AND PATIENTS: In a group of 160 consecutive patients operative exploration was performed in cases where arthrography and/or a delayed physical examination showed positive findings. In all patients arthrography was performed within 48 h after trauma. To determine interobserver agreement, all arthrograms were independently evaluated by two radiologists, both ignorant of the first assessment. RESULTS: The prevalence of an ankle ligament lesion was found to be 76%. Of the 122 patients with a rupture of one or more ankle ligaments, 52% had an isolated anterior talofibular ligament lesion, 3% had an isolated calcaneofibular ligament lesion, and 45% had combined lesions. The site of the lesion was predominantly intraligamentous. In the determination of the presence or absence of an ankle ligament lesion, the specificity and sensitivity of the ankle arthrogram were 71% and 96% respectively. Interobserver agreement on the arthrogram was very good (kappa 0.9). In 1% of patients a clear diagnosis was not possible by means of arthrography. CONCLUSION: Arthrography provides information of high diagnostic quality with excellent interobserver agreement and therefore remains the gold standard for early diagnosis (within 48 h) of a lateral ankle ligament rupture.
Adolescent↗
Clarification of fertility after tubal surgery for ectopic pregnancy.
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Fallopian Tubes↗
Sensitivity specificity and likelihood ratios--do they deserve confidence intervals?
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Chorionic Gonadotropin↗
Systemic methotrexate therapy versus laparoscopic salpingostomy in patients with tubal pregnancy. Part I. Impact on patients' health-related quality of life.
OBJECTIVE: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic salpingostomy for tubal pregnancy. DESIGN: Multicenter randomized clinical trial. SETTING: Departments of obstetrics and gynecology of six Dutch hospitals. PATIENT(S): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic salpingostomy. INTERVENTION(S): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks. and 16 weeks after confirmative laparoscopy. MAIN OUTCOME MEASURE(S): Health-related quality of life. RESULT(S): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. CONCLUSION(S): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
Adaptation, Psychological↗