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Biomedical subjects

K F Schulz

Publications and source records attributed to K F Schulz.

At least 55 records · Page 3Linked to original sources
PubMed2001

Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence.

OBJECTIVE: Assess the safety and efficacy of intrauterine contraceptive device (IUCD) insertion immediately after induced or spontaneous abortion. DESIGN: Systematic search for randomised trials that had at least one treatment arm that involved IUCD insertion immediately after an induced or spontaneous miscarriage using Medline, Popline, EMBASE, and review articles supplemented by correspondence with investigators. POPULATION: Women of any age or gravidity who had an IUCD inserted immediately after evacuation for spontaneous or induced abortion. METHODS: Articles were abstracted and the raw data from tables were analysed with RevMan 3.1 software. We focused on Tietze-Potter gross life table probabilities with denominators of person-time of exposure. MAIN OUTCOME MEASURES: Rates of perforation, expulsion, pelvic inflammatory disease, contraceptive failure, and method continuation. RESULTS: Complication rates for immediate post-abortal IUCD insertion were low. Perforation was rare with a rate of approximately one per 1,000 insertions. One year gross cumulative expulsion rates ranged from 1.8% to 12.6%, pregnancy rates from 0.6% to 2.1%, and continuation rates from 54% to 90%. The net discontinuation rate due to pelvic inflammatory disease was low, ranging from 0.0 to 0.8 per 100 women at one year. Increasing gestational age at insertion was associated with increased expulsion rates. CONCLUSIONS: Post-abortal IUCD insertion is safe and effective. The risks of perforation, expulsion, pelvic inflammatory disease and contraceptive failure were low and similar to those reported for interval insertion. Second trimester gestational age is associated with an increased risk of expulsion. Immediate insertion may have a higher expulsion rate than delayed insertion. However, these risks may be outweighed by the benefit of immediate contraception.

Abortion, Induced↗
PubMed2001

Assessing allocation concealment and blinding in randomised controlled trials: why bother?

As users of RCT results, we must understand the potential for humans to interject bias. By describing assessments of allocation concealment and blinding, abstracts included in Evidence-Based Nursing will help readers to discern those trials that have made superior efforts to minimise bias. Judging the quality of allocation concealment and blinding reflects current empirical research and reflects the commitment of the editors of this journal to apply the principles of evidence-based practice to reporting of study findings.

Double-Blind Method↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗
PubMed2000

Antibiotic prophylaxis for intrauterine contraceptive device insertion.

BACKGROUND: Concern about the risk of upper genital tract infection (pelvic inflammatory disease) often limits use of the IUD, a highly effective contraceptive. Prophylactic antibiotic administration around the time of induced abortion significantly reduces the risk of postoperative endometritis.(Sawaya, 1996) Since the risk of IUD-related infection is limited to the first few weeks to months after insertion,(Lee, 1983; Farley, 1992) contamination of the endometrial cavity at the time of insertion(Mishell, 1966) appears to be the mechanism, rather than the IUD or string itself. Thus, antibiotic administration before IUD insertion might reduce the risk of upper genital tract infection from passive introduction of bacteria at insertion. OBJECTIVES: To assess the effectiveness of prophylactic antibiotic administration before IUD insertion in reducing IUD-related complications and discontinuations within three months of insertion. The primary outcome was pelvic inflammatory disease (four reports) or early removals of the device (two reports). SEARCH STRATEGY: We searched both MEDLINE and EMBASE, handsearches of journals through CENTRAL, and lists of references. We also wrote to international experts in the field to identify unpublished studies. SELECTION CRITERIA: We included randomized controlled trials using any antibiotic compared with a placebo. We found four such trials; two had pilot study data available. DATA COLLECTION AND ANALYSIS DATA EXTRACTION: We used searches of MEDLINE, EMBASE, and handsearches of journals available through CENTRAL. We also reviewed lists of references in original research and in review articles. We wrote to experts to identify unpublished trials and made telephone calls to authors to supply missing information. Two independent reviewers abstracted data. We assessed the validity of each study using methods suggested in the Cochrane Handbook. DATA SYNTHESIS: We generated 2x2 tables for the principal outcome measures. We used the Peto modified Mantel-Haenszel technique to calculate odds ratios and assessed statistical heterogeneity between studies. MAIN RESULTS: The odds ratios for pelvic inflammatory disease associated with use of prophylactic doxycycline or azithromycin compared with placebo or no treatment was 0.89 (95%CI 0.53-1.51). Use of prophylaxis was associated with a small reduction in unscheduled vists to the provider (OR 0.82; 95% CI 0.70-0.98). Use of doxycycline or azithromycin had little effect on the likelihood of removal of the IUD within 90 days of insertion (OR 1.05; 95% CI 0.68-1.63). Significant heterogeneity did not exist between studies. REVIEWER'S CONCLUSIONS: Use of either doxycycline 200 mg or azithromycin 500 mg by mouth before IUD insertion confers little benefit. While the reduction in unscheduled visits to the provider was marginally significant, the cost-effectiveness of routine prophylaxis remains questionable. A uniform finding in these trials was the low risk of IUD-associated infection, with or without use of antibiotic prophylaxis.

Antibiotic Prophylaxis↗
PubMed2000

Abortion surveillance at CDC: creating public health light out of political heat.

In the late 1960s, states began to liberalize their abortion laws, and a new era in women's health began. Under the leadership of Jack Smith, the Centers for Disease Control and Prevention (CDC) established a voluntary abortion surveillance system that provided the first nationwide information on the numbers and characteristics of women having abortions. Studies of abortion morbidity done by the CDC revealed that suction curettage was safer than sharp curettage, local anesthesia was safer than general anesthesia, free-standing clinics were safer than hospitals, and dilation and evacuation (D&E) was safer than the alternative of labor induction for early second-trimester abortions. This evidence, which contradicted traditional medical tenets, rapidly changed the practice of abortion in the United States. CDC also established a surveillance system for abortion deaths. This demonstrated a rapid improvement in the safety of abortion in the early 1970s. Lessons learned from mortality investigations helped to change practice as well.Today, more is known about the epidemiology of abortion than any other operation in the history of medicine. In the midst of strident debate over the abortion issue, CDC abortion surveillance data have helped to guide judicial rulings, legislative actions, and Surgeon General's reports, which have supported safer choices for women of reproductive age. When medical historians of the future look back on this century, the increasing availability of safe, legal abortion will stand out as a public health triumph.

Abortion, Induced↗
PubMed2000

What contributions do languages other than English make on the results of meta-analyses?

Including only a portion of all available evidence may introduce systematic errors into the meta-analytic process and threaten its validity. We set out to examine whether language restricted meta-analyses, compared to language inclusive meta-analyses, provide different estimates of the effectiveness of interventions evaluated in randomized trials. We identified and retrieved all 79 meta-analyses from several disease areas in which explicit eligibility criteria regarding trial selection were reported. General characteristics and quality of reporting of the meta-analyses were assessed using a validated instrument. We explored the effects of language of publication of the randomized trials on the quantitative results using logistic regression analyses. Language restricted meta-analyses, compared to language inclusive meta-analyses, did not differ with respect to the estimate of benefit of the effectiveness of an intervention (ROR = 0.98; 95% CI: 0.81-1.17). These results were also robust after a series of sensitivity analyses. This study provides no evidence that language restricted meta-analyses lead to biased estimates of intervention effectiveness. We encourage others to replicate this study using different sampling frames, clinical topics and interventions.

Humans↗
PubMed2000

A faculty development course in obstetrics and gynecology.

Sponsored by the nonprofit Berlex Foundation, this 6-day Faculty Development Course introduces small groups of new faculty to research design, critical appraisal of the literature, scientific writing, and evidence-based medicine. The course includes didactic presentations, small group discussions, and individual protocol development. Its influence on academic careers is impossible to determine, because defining an appropriate comparison group is not feasible. However, the cumulative effect should be to increase the research expertise of some young faculty in academic departments nationwide. In addition, many participants have introduced the principles of evidence-based medicine in their own teaching programs.

Curriculum↗
PubMed1999

Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials.

We evaluated the effectiveness of prophylactic antibiotic administration before IUD insertion in reducing the incidence of pelvic inflammatory disease, unscheduled visits back to the clinician, and IUD discontinuations within 3 months of insertion. We performed a metaanalysis of all known randomized controlled trials comparing an antibiotic (either oral doxycycline or azithromycin) versus a placebo or no treatment. Use of prophylaxis significantly reduced the frequency of unscheduled return visits (odds ratio 0.82; 95% CI 0.70, 0.98). The protection against pelvic inflammatory disease was smaller and not statistically significant 0.89 (95% CI 0.53, 1.51). No significant effect on premature IUD discontinuation was evident. Use of either doxycycline or azithromycin before IUD insertion offered little observable benefit in the US. Prophylaxis reduced unscheduled visits and possibly PID in developing countries, which have higher rates of sexually transmitted diseases than in the US. A more important finding in these trials is the low incidence of pelvic inflammatory disease with or without prophylactic antibiotics.

Adult↗
PubMed1998

Measuring true contraceptive efficacy. A randomized approach--condom vs. spermicide vs. no method.

No investigator has attempted to measure prospectively the true efficacy of a contraceptive method, compared with a control group using no method, because contraceptive trials focus on women trying to avoid pregnancy and ethical concerns do not permit the withholding of contraception. We tested the feasibility of an approach that recruited women who desired pregnancy but were willing to postpone conception by 1 month. In this protocol, we restricted frequency and timing of intercourse to one coital act on the most fertile day of the menstrual cycle, as measured by a luteinizing hormone (LH) detection kit. Participants were randomized to use either a male latex condom, spermicidal film, or no method. In this feasibility study we recruited 58 women at three sites, with one site recruiting 25 women in 5 months. Among 54 women who completed the study, we found a 12% pregnancy rate for the group using no method (2/17; 95% confidence interval [CI], 1-36%) and an 11% pregnancy rate for the group using spermicidal film (2/18; 95% CI, 1-35%). No pregnancies occurred among the 19 women using condoms (0/19; 95% CI, 0-18%). The wide confidence intervals illustrate the small sample size of this pilot study and no conclusions can be drawn about the relative efficacy of the methods. Having demonstrated the feasibility of this study design, we now urge the initiation of a large-scale study to evaluate the efficacy of barrier methods using our randomized approach, with a control arm using no method of contraception.

Adult↗
PubMed1996

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology.

OBJECTIVE: To assess the methodological quality of approaches to blind ing and to handling of exclusions as reported in randomised trials from one medical specialty. DESIGN: Survey of published, parallel group randomised controlled trials. DATA SOURCES: A random sample of 110 reports in which allocation was described as randomised from 1990 and 1991 volumes of four journals of obstetrics and gynaecology. MAIN OUTCOME MEASURES: The adequacy of the descriptions of double blinding and exclusions after randomisation. RESULTS: Through 31 trials reported being double blind, about twice as many could have been. Of the 31 trials only eight (26%) provided information on the protection of the allocation schedule and only five (16%) provided some written assurance of successful implementation of double blinding. Of 38 trials in which the authors provided sufficient information for readers to infer that no exclusions after randomisation had occurred, six (16%) reported adequate allocation concealment and none stated that an intention to treat analysis had been performed. That compared with 14 (27%) and six (12%), respectively, for the 52 trials that reported exclusions. CONCLUSIONS: Investigators could have double blinded more often. When they did double blind, they reported poorly and rarely evaluated it. Paradoxically, trials that reported exclusions seemed generally of a higher methodological standard than those that had no apparent exclusions. Exclusions from analysis may have been made in some of the trials in which no exclusions were reported. Editors and readers of reports of randomised trials should understand that flawed reporting of exclusions may often provide a misleading impression of the quality of the trial.

Double-Blind Method↗
PubMed1996

Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology.

OBJECTIVES: Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references. STUDY DESIGN: We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria. RESULTS: Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.

Bibliographies as Topic↗