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Biomedical subjects

P D Blumenthal

Publications and source records attributed to P D Blumenthal.

At least 19 recordsLinked to original sources

Training for Norplant implant removal: assessment of learning curves and competency.

OBJECTIVE: To determine the learning curves and rapidity with which clinicians become competent in implant removal using two Norplant removal techniques. METHODS: Twenty-four physicians, none of whom were experienced in the use of Norplant implants, were randomly assigned to learn either the "U" removal technique or the standard technique. The physicians in the two groups received identical training in all other respects. Each physician then performed ten supervised removals. Removal times, procedure problem rates, and the number of procedures performed by the clinicians before they were judged "competent" were assessed for both groups. RESULTS: Data from 240 removals were analyzed. Mean removal times were 38% faster in the "U" group than in the standard group. None of the "U" group procedures took longer than 20 minutes, compared with 11% of removals in the standard group (P < .001). The mean number of cases required before the provider consistently performed all steps adequately was significantly (P < .02) higher in the standard group (5.8 cases) than in the "U" group (3.9 cases). CONCLUSIONS: Using competency-based training methods, the "U" removal technique was learned easily by inexperienced clinicians. It appears to offer significant improvements in speed and achievement of proficiency over the standard technique recommended by the manufacturer. Large-scale programs should consider using competency-based training and the "U" technique as the removal method of choice when providing training in implant removal.

Clinical Competence

Usefulness of a clinical scoring system to anticipate difficulty of Norplant removal.

OBJECTIVES: Removal of contraceptive implants (e.g. Norplant) is an issue affecting its worldwide acceptability. Reports of difficult, painful removals have resulted in lawsuits and reduced demand. To improve quality of care, we developed a scoring system to anticipate difficult removals. We report on the usefulness of such a system and present client perspectives about the removal experience. METHODS: A 9-point scoring system based on the visibility, arrangement, and position (VAP) of Norplant capsules was used to assess the anticipated difficulty of removal in 53 consecutive patients. The VAP score was then correlated with removal time and related parameters. RESULTS: Mean removal time was 14.74 min (range 4.75-47). In 20% of patients, the VAP score indicated a potentially difficult removal and the VAP score correlated significantly with removal time (r = 0.3, p = 0.05). Patients expected removal to be moderately difficult (mean visual analog score 4.7 out of a possible 10), but after removal they rated the actual removal experience as relatively easy (mean score 2.6/10). Before the removal, only 48% of patients said they would recommend Norplant to a friend but after removal, 70% said they would do so. CONCLUSIONS: A scoring system such as the VAP score can help identify potentially difficult removals so that an experienced remover can be present at the time of removal or an appropriate referral made. However, the VAP score cannot predict variables such as the density of the subcutaneous fibrous tissue "envelope". Although patient anxiety concerning removal may be high, the presence of a competent remover and an easy removal experience reduces this anxiety and encourages patients to be more positive about this method. The value of having properly trained, competent personnel available to perform removals cannot be over-emphasized.

Anesthetics, Local

Laparoscopic sterilization in the supine position using the Ramathibodi uterine manipulator.

OBJECTIVES: To investigate the usefulness of the Ramathibodi uterine manipulator (AMZURA Enterprises, Freeport, NY) in performing laparoscopic sterilization procedures in the supine position under local anesthesia. DESIGN: Descriptive prospective study. SETTING: Ambulatory surgical unit of university-affiliated hospital. PATIENTS: Women presenting for elective sterilization and weighing < 110 kg. INTERVENTION: The Ramathibodi uterine manipulator was used to provide uterine manipulation in 85 cases of laparoscopic sterilization, all performed in the supine position as local anesthesia-sedation sterilization operations. Because such procedures are becoming more common worldwide, we propose the acronym "LASSO" (Local Anesthesia-Sedation Sterilization Operation) for this class of operations. Although commonly used in minilaparotomy procedures, use of this uterine manipulation device in laparoscopic procedures has not been published previously. MAIN OUTCOME MEASURE: Successful tubal occlusion. RESULTS: Among the 85 cases reported here there were no failures to manipulate the uterus successfully, to identify the tubes, and to occlude them. CONCLUSIONS: The simplicity of the Ramathibodi uterine manipulator provided several advantages over other means of uterine manipulation, notably [1] constant easy-to-learn maneuvers, [2] no tenaculum or balloon requirement, [3] the procedure could be performed in the supine position, and [4] there are no working parts, screws, or springs that could be lost or broken by operating room staff. Our experience with this device leads us to recommend it to colleagues as an inexpensive, safe, and effective alternative to currently available instruments for providing uterine elevation during laparoscopic sterilization procedures.

Anesthesia, Local

Contraceptive outcomes among post-partum and post-abortal adolescents.

Between January 1992 and January 1993, there were 280 teens (ages 13-18) who either delivered a baby or terminated a pregnancy at Johns Hopkins Bayview Medical Center. Of these, 92 chose to contracept with Norplant implants, and 188 chose another method including "no" method. In July 1993, telephone interviews were conducted with 37 of those who chose Norplant implants and 41 of the non-Norplant implants users. After 1 year, 47% of oral contraceptive (COC) users had discontinued the method compared to only 16% of Norplant implants users (P < 0.03). Reasons for discontinuation centered on side effects for both groups but with some COC and condom users, discontinuing use due to "forgetfulness" or failure (pregnancy). Among the COC group (which was the most common choice after Norplant implant), 25% of the adolescents had experienced a subsequent unplanned pregnancy compared to 0% of the Norplant implant group (P < 0.01). Norplant implants were clearly an acceptable and effective contraceptive for these post-partum and post-abortal teens, who articulated a high motivation to avoid a subsequent unplanned pregnancy. However, it is clearly not the only method teens will choose to use, and more attention must be paid to adequate counseling of those choosing another method.

Abortion, Induced

A time and cost analysis of the management of incomplete abortion with manual vacuum aspiration.

OBJECTIVES: Traditionally, management of incomplete abortion involves use of D&C or suction curettage in the operating room. Such management is costly and time-consuming. In order to potentially save time and money, we studied the use of manual vacuum aspiration curettage (MVAC) for the management of this problem. METHODS: Data on hospital charges and times (e.g. waiting time, procedure time) were obtained for all cases of incomplete abortion presenting to hospital between January 1990 and July 1992. Between January 1990 and July 1991, all cases were managed traditionally. After July 1991, all cases were managed using MVAC in either the emergency room or the labor ward. RESULTS: Compared to the use of electrical suction equipment in the operating theatre, MVAC procedures resulted in significant savings in terms of both waiting times and costs. Waiting time was reduced by 52% and procedure time was reduced from a mean of 33 min to 19 min (P < 0.01). Total hospital costs were reduced by 41% (P < 0.01). CONCLUSIONS: Use of manual vacuum aspiration curettage in the management of incomplete abortion can reduce hospital costs and save time for both patients and clinicians.

Abortion, Incomplete

Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants.

OBJECTIVE: To compare acceptability, tolerance of side effects, and continuation rates among adolescent and adult Norplant accepters. METHODS: An 18-month observational study was conducted of 136 adolescents and 542 adults who received Norplant at the Francis Scott Key Medical Center in Baltimore, Maryland. Data were collected from the following: a self-administered history form completed at the preinsertion visit, a self-administered follow-up form completed at routine follow-up visits, problem-visit chart review, and telephone contact for patients noncompliant with follow-up appointments. RESULTS: The adolescents ranged in age from 13-18 years (mean 16.4), and adults ranged in age from 19-46 (mean 24.7). The mean parity among teenagers was 1.4; among adults, 3.2. Thirty-nine percent of teenagers and 64% of adults had had one or more therapeutic abortions. Forty percent of adolescents and 47% of adults reported at least one contraceptive failure in the past. Both adolescent and adult Norplant accepters made few telephone calls or problem visits because of complaints or side effects. Compliance with routine annual follow-up was poor for adolescents (24 of 136, 18%) and adults (72 of 542, 13%). Follow-up of noncompliant patients revealed low rates of implant removal. Fifteen adolescents (11%) and 60 adults (11%) had Norplant removed. The most common reasons for removal included irregular bleeding, weight gain, headaches, and desire for pregnancy. CONCLUSIONS: Implant acceptability, continuation, and tolerance of side effects were high and comparable among adolescent and adult accepters. Initial implant users were primarily adolescents or adults who had experienced problems with other forms of reversible contraception. Adherence to scheduled follow-up appointments was poor, regardless of age.

Adolescent

Recovery from outpatient laparoscopic tubal ligation is not improved by preoperative administration of ketorolac or ibuprofen.

The analgesic efficacy of a single dose of ketorolac or ibuprofen given preoperatively was assessed in healthy outpatients undergoing general anesthesia for laparoscopic tubal ligation. Fifty patients were randomized to receive either ketorolac 60 mg intravenously (i.v.), ibuprofen 800 mg orally, or placebo in a double-blind manner. Anesthesia was induced with fentanyl 2 micrograms/kg, thiopental 5 mg/kg, and either vecuronium 0.1 mg/kg or succinylcholine 1.5 mg/kg i.v. and was maintained with nitrous oxide 67% in oxygen and isoflurane. Patients were assessed at 15-min intervals in the postanesthesia care unit (PACU) and treated for pain with i.v. morphine by protocol. Patients were evaluated for pain, analgesic requirements, side effects, and recovery times. After discharge, patients completed questionnaires to assess pain, analgesic use, and side effects 6 and 24 h postoperatively. Parenteral morphine was required in 80% of patients in the control group, and 73% of patients in both treatment groups, and the difference was not statistically significant. The dose of parenteral morphine required in the PACU was not different between the control (7 +/- 1.2 mg), ibuprofen (5.7 +/- 1.4 mg), and ketorolac (6.1 +/- 1.4 mg) groups. There was no difference between groups in terms of pain visual analog scale (VAS) scores, fatigue VAS scores, recovery times, or the incidence of postoperative nausea and vomiting. The preoperative administration of either parenteral ketorolac or oral ibuprofen did not decrease postoperative pain or side effects when compared to placebo in this outpatient population.

Adult

Preliminary experience with Norplant in an inner city population.

Norplant, the five-year subdermal contraceptive system, is the first implantable contraceptive method approved for general use in the United States. We describe the preliminary experiences of 246 U.S. women who accepted Norplant between April, 1991 and September, 1991. Norplant was well accepted among this diverse general population. Intensive counselling about side effects, especially menstrual changes, is crucial for patient satisfaction. Although 48% of acceptors experienced menstrual cycle changes and 70% experienced at least one side effect, phone calls and unscheduled visits for problems were infrequent. Adequate counselling about side effects obviates the need for a routine follow-up visit one month after insertion.

Adolescent

Abortion: epidemiology, safety, and technique.

In 1991, the abortion literature was characterized by articles relating to 1) epidemiologic issues in abortion care, 2) advances in knowledge and experience with medical abortifacients such as mifepristone (RU 486), and 3) cervical ripening prior to abortion with the use of both mifepristone and prostaglandins. Technical methods of achieving termination of pregnancy continue to be similar in the United States, the United Kingdom, and Europe, although induction-abortion times are generally slower in Europe than in the United States. Surgically, dilatation and evacuation procedures continue to be more common in the United States than in other countries. The effectiveness of mifepristone is undisputed, and the recommended dose for early first-trimester termination is being compared with lower dose alternative regimens. There is additional evidence that at least in the short term, the negative psychological sequelae of abortion are infrequent and are inconsequential as a public health issue.

Abortion, Incomplete

Abortion.

In 1990 abortion literature was characterized by articles relating to 1) the safety of surgical abortion procedures, 2) advances in knowledge and experience with medical abortifacients such as mifepristone (RU 486), and 3) reviews of psychologic and ethical considerations. Although technical methods differ greatly between countries and continents, there is increasing similarity between termination protocols in the United States, the United Kingdom, and Europe. The advent of mifepristone will make this even more so. Surgically, although dilatation and evacuation procedures are far more common in the United States than in other countries, the literature reflects a fine-tuning of analysis and technique, with safety the major consideration. Knowledge about the effectiveness of mifepristone continues to grow, and the effective dose for early first-trimester termination appears established. There is increasing evidence that at least in the short term, the negative psychologic sequelae of abortion are infrequent and are inconsequential as a public health issue.

Abortion, Induced

Letter from Africa.

A day in obstetric-gynecologic practice in Kenya involves uterine rupture and other conditions resulting from inadequate care and facilities for labor, as well as infected abortions. Technology and equipment taken for granted in America either don't exist or don't work. Although practice is primitive in many ways, some of the concerns of doctors are the same as in developed countries.

Gynecology

Randomized trial of Dilapan and Laminaria as cervical ripening agents before induction of labor.

A randomized trial was conducted to evaluate the comparative effectiveness of Dilapan cervical dilators and Laminaria japonicum as cervical ripening agents before induction of labor at term. Patients with Bishop scores of 4 or less and a fetal or maternal indication for induction at 34 or more weeks' gestation were eligible for the study. The outcome variables of interest were Bishop score upon removal of the devices, number of devices used, induction-to-delivery time, and induction-to-complete dilatation time. In the Dilapan group, an average of 4.3 devices per patient was used, compared with 9.7 devices in the laminaria group (P less than .01). Among patients who eventually achieved complete dilatation, the mean (+/- SD) time for the Dilapan group was 10.8 +/- 6.1 hours, compared with 14.7 +/- 9.2 hours with laminaria. For women undergoing induction of labor at term with an unripe cervix, Dilapan appeared to be a preferable alternative to Laminaria japonicum because its use may result in a shorter induction-to-delivery interval with fewer devices required to obtain significant cervical ripening.

Adult

Comparison of the nipple stimulation and exogenous oxytocin contraction stress tests. A randomized, prospective study.

In a prospective, randomized trial, 103 women underwent a total of 203 antenatal stress tests. One hundred four nipple stimulation contraction stress tests (BSTs) and 99 oxytocin challenge tests (OCTs) were performed. The patient populations were similar for the two groups. Uterine hyperstimulation with abnormal fetal heart rate patterns occurred with 2.9% and 1% of the BSTs and OCTs, respectively. The failure rate for the BST group was 22%. Maternal age and weight, parity and gestational age were not associated with test failure. Only one patient failed more than one BST, but she did not fail every such test. When test time (time from initiation to completion of the test) was compared between the two groups, a significant difference was found when the BST was successful. However, when test time in the total BST group (successful and unsuccessful BSTs followed by an OCT was compared to that in the OCT group, no difference could be found. Though an OCT following an unsuccessful BST took longer to perform than did a primary OCT, the difference was not statistically significant. It appears that BST test failure may relate more to the technique of nipple stimulation used than to intrinsic patient factors.

Breast

Prospective comparison of Dilapan and laminaria for pretreatment of the cervix in second-trimester induction abortion.

Fifty-four women presenting for second-trimester induction abortion received either Dilapan synthetic dilators or laminaria for pretreatment of the cervix before induction abortion using intra-amniotic prostaglandin (PG) F2 alpha. The two groups were similar with respect to age, parity, previous abortion, and gestational age. Neither group experienced any unusual complications. The same protocol for intraamniotic PGF2 alpha (40 mg) was used in all patients except for three with histories of asthma, in whom PGE2 vaginal suppositories (20 mg) were used as the induction agent. For the Dilapan group, an average of three devices was used, compared with an average of six in the laminaria group. The mean (+/- SEM) induction-abortion time for Dilapan patients was 10.9 +/- 1.3 hours, compared with 16.1 +/- 1.4 hours in the laminaria group, a statistically significant difference (P less than .05). When nulliparous women were examined separately, the mean times were 11.0 +/- 1.7 for Dilapan and 16.5 +/- 1.6 for laminaria, a medically relevant and statistically significant difference (P less than .05). Dilapan appears to be an effective alternative to laminaria that results in shorter induction-abortion intervals.

Abortion, Induced

Problem visits to a family planning clinic.

In order to obtain information necessary for optimum delivery of services, data were collected on the nature of the services provided at a family planing clinic. Clinic visits were divided into initial, annual, routine, problem, supply, educational and unknown. An analysis of the "problem" visits was undertaken to assess various epidemiologic aspects of such visits and to identify areas of clinic efficiency that could be improved. Problem visits were defined as any visits for which the patient had a presenting complaint. Age, level of education, method of contraception and parity were statistically associated with problem visits. When compared to Pill users, diaphragm users, intrauterine device users and non-users had a higher-than-expected number of problem visits. Less educated women and teenagers had a lower-than-expected number of problem visits when compared to more educated and older women. Socioeconomic status and problem visits were not statistically associated. Problem visits required more time, utilized more medical services and resulted in more referrals to the gynecology clinic than did other visit types. As a result of this analysis, we have increased our educational efforts for patients at high risk of problem visits and have instituted a special problem-oriented family planning clinic in which a full complement of house staff and ancillary personnel are available. This arrangement makes the uncomplicated family planning clinic run more smoothly and efficiently and obviates the need for time-consuming and cost-ineffective referrals.

Adolescent