EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy.
(65/401)
OBJECTIVES: To test the null hypothesis of no significant difference between laparoscopic hysterectomy (LH), abdominal hysterectomy (AH) and vaginal hysterectomy (VH) with regard to each of the outcome measures of the trial, and also to assess the cost-effectiveness of the alternatives. DESIGN: Patients were allocated to either the vaginal or abdominal trial by the individual surgeon according to their usual clinical practice. After allocation patients were then randomised to receive either LH or the default procedure in an unbalanced 2:1 manner. SETTING: Forty-three surgeons from 28 centres throughout the UK and two centres in South Africa took part in the study. PARTICIPANTS: Patients with gynaecological symptoms that, in the opinion of the gynaecologist and the patient, justified hysterectomy. INTERVENTIONS: Of 1380 patients recruited to the study, 876 were included in the AH trial and 504 in the VH trial. In the AH trial, 584 patients had a laparoscopic type of hysterectomy (designated ALH) and 292 had a standard AH. In the VH trial 336 had a VLH and 168 had a standard VH. A cost--utility analysis was undertaken based on a 1-year time horizon. Quality-adjusted life years (QALYs) were estimated using the EQ-5D. RESULTS: Compared with AH, LH was associated with a higher rate of major complications, less postoperative pain and shorter hospital stay, but took longer to perform. Securing the ovarian pedicles with laparoscopic sutures was used in only 7% of cases but was associated with 25% of the complications. At the 6 weeks postoperative point, ALH was associated with a significantly better physical component of the SF-12 (QoL questionnaire), better body image scale scores and a significantly increased frequency of sexual intercourse than AH. These differences were not observed at either 4 or 12 months after surgery. There were no significant differences in any measured outcome between LH and VH except that VLH took longer to perform and was associated with a higher rate of detecting unexpected pathology. Compared with VH, VLH had a higher mean cost per patient of GBP401 and higher mean QALYs of 0.0015, resulting in an incremental cost per QALY gained of GBP267,333. The probability that VLH is cost-effective was less than 50% for a large range of willingness to pay values for an additional QALY. Compared with AH, ALH had a higher mean cost per patient of GBP186 and higher mean QALYs of 0.007, resulting in an incremental cost per QALY gained of GBP26,571. CONCLUSIONS: ALH is associated with a significantly higher risk of major complications and takes longer to perform than AH. ALH is, however, associated with less pain, quicker recovery and better short-term QoL after surgery than AH. The cost-effectiveness of ALH is finely balanced and is also influenced by the choice of reusable versus disposable equipment. Individual surgeons must decide between patient-orientated benefits and the risk of severe complications. VLH was not cost-effective relative to VH. Recommendations for future research include the application and relevance of QoL measures following hysterectomy, and long-term follow-up; patient preferences; reducing complication rates; improving gynaecological surgical training; surgeon effect in surgery trials; care pathways for hysterectomy; additional pathology identification in LH and meta-analysis/further trial of VH versus LH. (+info)
Effect of prize draw incentive on the response rate to a postal survey of obstetricians and gynaecologists: a randomised controlled trial. [ISRCTN32823119].
(66/401)
BACKGROUND: Response rates to postal questionnaires are falling and this threatens the external validity of survey findings. We wanted to establish whether the incentive of being entered into a prize draw to win a personal digital assistant (PDA) would increase the response rate for a national survey of consultant obstetricians and gynaecologists. METHODS: A randomised controlled trial was conducted. This involved sending a postal questionnaire to all Consultant Obstetricians and Gynaecologists in the United Kingdom. Recipients were randomised to receiving a questionnaire offering a prize draw incentive (on response) or no such incentive. RESULTS: The response rate for recipients offered the prize incentive was 64% (461/716) and 62% (429/694) in the no incentive group (relative rate of response 1.04, 95% CI 0.96 - 1.13) CONCLUSION: The offer of a prize draw incentive to win a PDA did not significantly increase response rates to a national questionnaire survey of consultant obstetricians and gynaecologists. (+info)
Adoption of liquid-based cervical cancer screening tests by family physicians and gynecologists.
(67/401)
OBJECTIVE: To examine reasons for the adoption of liquid-based cervical cancer screening tests. DATA SOURCES/STUDY SETTING: A mailed survey of 250 family physicians and 250 gynecologists in Maryland in 2000. Additional data were obtained from the AMA Master File of Physicians. STUDY DESIGN: Key outcome variables in this cross-sectional survey were early adoption of a liquid-based test by the end of 1997 and overall adoption by the time of the survey. Adoption was viewed in terms of a supply and demand theoretical framework with marketing influencing physician and patient demand as well as supply by insurance companies and laboratories. DATA COLLECTION: Random samples of family physicians and gynecologists were selected from the AMA Master File of Physicians. The overall response rate was 61.9 percent. PRINCIPAL FINDINGS: By 2000, 96 percent of gynecologists and 75 percent of family physicians in Maryland were using liquid-based cervical cancer screening tests, most commonly the ThinPrep Pap Test. Gynecologists were more likely than family physicians to have been early adopters (34 percent versus 5 percent, p<.01). Part of this variation in adoption was due to aggressive marketing to gynecologists, who were more likely than family physicians to receive information in the mail from the test manufacturer (89 percent versus 56 percent, p<.01) and to have been informed by the manufacturer that a patient had inquired about physicians' use of the test (22 percent versus 8 percent, p<.01). CONCLUSIONS: The rapid diffusion of liquid-based cervical cancer screening tests occurred despite general agreement that the Pap smear has been one of the most successful cancer prevention interventions ever. Commercial marketing campaigns appear to contribute to the more rapid rate of diffusion of technology among specialists compared with generalists. (+info)
Stem cells in gynecology and obstetrics.
(68/401)
Over the past 10 years, we have become involved in a new research effort and an increasing scientific interest in the field of stem cell-based therapy. We are therefore able to describe different areas in which stem cell research can be applied and developed in gynecology and obstetrics. I) Hematopoietic stem cells have been used to set up therapeutic strategies for the treatment of gynecological solid tumors such as ovarian cancer. In this context different autologous or allogeneic transplantation approaches have been proposed and clinically investigated. II) Umbilical cord blood, which was often considered a waste material of the delivery, actually represents a precious source of stem cells that can be used for cell-based treatments of malignancies and inherited diseases. III) A feto-maternal cell traffic has recently been demonstrated through the placental barrier during pregnancy. This cellular exchange also includes stem cells from the fetus, which can generate microchimerisms in the mother and contribute to tissue repair mechanisms in different maternal organs. IV) Stem cells can be used for prenatal transplantation to treat different severe congenital diseases of the fetus. Nevertheless, several problems need to be solved to achieve an efficient in utero stem cell transplantation. Recent reports have pointed out the importance of timing in prenatal stem cell transplantation procedures and have shown the advantage of an early stem cell injection. An ultrasound-guided intracelomic approach could allow this possibility. (+info)
The accreditation of ultrasound practices: impact on compliance with minimum performance guidelines.
(69/401)
OBJECTIVE: To determine the effectiveness of the American Institute of Ultrasound in Medicine (AIUM) accreditation program in improving compliance with standards and guidelines for the performance of obstetric and gynecologic ultrasound examinations. METHODS: Scores of case studies of accreditation applications were compared with their respective scores at the time of reaccreditation 3 years later. To account for the element of time, scores of applications that recently completed first-time accreditation were also compared as a control group. RESULTS: Individual obstetric case studies, as well as the average of all obstetric and gynecologic case studies, showed highly significant improvement with the reaccreditation application when compared with the initial accreditation application 3 years earlier (all P <.001). The proportion of practices successfully meeting obstetric and gynecologic AIUM accreditation requirements improved significantly with reaccreditation (obstetric, 57.3% for accreditation compared with 86.6% for reaccreditation; gynecologic, 60% for accreditation compared with 91.9% for reaccreditation; P <.001). Furthermore, reaccreditation scores were significantly higher than scores of recent first-time applications for obstetric case studies as well as scores of the average of obstetric and gynecologic case studies (all P <.05). CONCLUSIONS: Our study confirms that practices that sought and received ultrasound accreditation were able to improve the scores of case studies and compliance with published minimum standards and guidelines for the performance of obstetric and gynecologic ultrasound examinations when reevaluated 3 years after the initial application scores. This improvement should translate into an enhancement of the quality of ultrasound practice. (+info)
Ultrasound training: the virtual patient.
(70/401)
OBJECTIVE: To evaluate an ultrasound training system designed to standardize teaching and learning of gynecological sonography using a virtual model. METHODS: The 'virtual patient' was based on a three-dimensional freehand ultrasound system that allows two-dimensional sonographic offline investigations of previously recorded cases, imitating a real gynecological scan. In the first test phase designed to check the congruence of real and virtual scans, 25 doctors experienced in ultrasound examined three virtual cases. During the second test phase we assessed whether training with the virtual patient helped to establish a satisfactory practical knowledge of gynecological ultrasound. This phase was carried out with 24 medical students without ultrasound experience. RESULTS: All 25 doctors successfully investigated the three cases and generated an accurate diagnosis for the first and second cases. In the third case 14 doctors made the correct diagnosis (uterus bicornis). The measurements of endometrial thickness and the diameter of a fibroid yielded acceptable results compared with the original investigation. After a short standardized video-based instruction, all 24 medical students were able to perform a basic transvaginal scan and to inspect the uterus, ovaries and the urinary bladder. Measurements of endometrial thickness by all students deviated minimally from the actual measurement. CONCLUSIONS: Training with the virtual patient appears to be comparable to performing a live gynecological ultrasound investigation and allows standardized ultrasound teaching and learning. (+info)
Evaluation of abnormal uterine bleeding: comparison of three outpatient procedures within cohorts defined by age and menopausal status.
(71/401)
OBJECTIVES: To compare three outpatient methods of endometrial evaluation in terms of performance, patient acceptability and cost-effectiveness. DESIGN: Pragmatic unblinded trial randomised separately within three groups determined by risk of endometrial cancer. SETTING: The gynaecology outpatient clinic of a large city hospital in Edinburgh, Scotland. PARTICIPANTS: Women referred for investigation and management of abnormal bleeding between January 1999 and May 2001. INTERVENTIONS: Investigations were: blind biopsy alone, hysteroscopy with biopsy, ultrasound evaluation including transvaginal ultrasound, and, in the low-risk group, the option of no investigation. Within this design, two devices for obtaining endometrial biopsy were compared, the Pipelle sampler and the Tao brush. MAIN OUTCOME MEASURES: Successful (informative) completion of the investigation, acceptability of the investigation method to women, women's satisfaction with clinic care in the short term and at 10 months and 2 years of follow-up, and cost-effectiveness to the end of investigation. RESULTS: Minor adverse events (e.g. shock, patient distress) did not occur for ultrasound, but occurred in 16% and 10% of women for hysteroscopy and biopsy procedures respectively. Pipelle biopsy provided an acceptable endometrial sample for 79% of moderate-risk women, but only 43% of high-risk women. The Tao brush gave similar performance in moderate-risk women (77%), but was more successful than the Pipelle sampler in postmenopausal (high-risk) women (72%). There were significantly more successful visualizations for ultrasound than for hysteroscopy in both the low-risk and the moderate-risk group, and a similar but non-significant trend in the high-risk group. Ultrasound was significantly better than hysteroscopy at detecting fibroids, but hysteroscopy significantly better for polyps. At the 10-month follow-up, high-risk women who had been investigated by hysteroscopy (with biopsy) had the most positive views of their clinic experience, but this effect had largely disappeared by 24 months. In the moderate-risk group, the subgroup randomised to biopsy alone gave the most negative responses about their clinic experience and health now. Women wishing they had more investigation comprised 22% of moderate-risk women and 38% of low-risk women, but only 14% of postmenopausal women. At follow-up the moderate-risk women (with menstrual bleeding problems), compared with postmenopausal women, had much worse ratings for clinic experience and health now. Resource use tended to be higher in the moderate- and low-risk women. There was minimal difference in cost-effectiveness between investigation options in the high-risk group, with the option involving hysteroscopy being marginally better than ultrasound. The most cost-effective investigation in the moderate-risk group was biopsy alone and in the low-risk group ultrasound. CONCLUSIONS: Decision-making about investigation would be clarified if postmenopausal women were studied separately from premenopausal women with menstrual bleeding problems. For postmenopausal women exclusion of cancer is a main objective, so once investigation has been completed discharge follows, but in the woman with abnormal menstrual bleeding, even if serious pathology is excluded, the original presenting symptoms require management. About 60% of premenopausal women with abnormal bleeding reported that their symptoms were not 'much improved' at 10 months. Research is needed to understand this phenomenon, and to explore ways to integrate patient factors into optimising evaluation and treatment. The significance of benign pathologies in this group also requires clarification. Given the relatively small differences observed in cost-effectiveness, there is justification for allowing other issues (such as clinician preferences and women's perspectives) to influence decisions as to the investigation method. There is scope to make better use of patient factors to inform decisions as to the most efficient and acceptable method of investigation for an individual woman. Additional analyses, using data available as a result of this study, will contribute to this agenda. (+info)
How ultrasound first came to new England.
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Diagnostic ultrasound came to Yale in the 1960s and was first developed in Glasgow and London. This story tells us that ultrasound was well-established in the Department of Obstetrics and Gynecology at Yale University School of Medicine in the Yale-New Haven Hospital by 1970. By then it had caught up with the pioneers in New York, Denver, and even Glasgow. (+info)