Clinical trials in the Journal of Pediatric Psychology: applying the CONSORT statement

OBJECTIVE: To determine how well therapeutic randomized controlled trials (RCTs) in the Journal of Pediatric Psychology (JPP) met the CONSORT criteria as compared to pediatric trials in the Journal of Clinical and Consulting Psychology (JCCP), which served as a control. METHODS: Nine trials were found in JPP and 19 clinical trials were retrieved from JCCP. The modified Consort Checklist and Flow Chart was applied to each trial by two unblinded independent raters. RESULTS: The number of CONSORT items not reported between the two journals was strikingly similar. One half (11/22) of the CONSORT items were reported less than 25% of the time. Information provided on the flow of participants in the trials was similar across the two journals; however, JCCP more often reported on those assessed to be eligible overall, chi(2) = 5.241, p <.05. JPP reported on recruitment 33.3% of the time, while it was not reported at all in JCCP, chi(2) = 7.093, p <.05. CONCLUSIONS: Although many of the items in the CONSORT statement were not adhered to by the two psychological journals, most of the CONSORT items can clearly be applied to psychosocial trials.     

The treatment of postnatal depression by health visitors: impact of brief training on skills and clinical practice

BACKGROUND: Postnatal depression can be effectively treated by cognitive behavioural counselling (CBC), a simple intervention designed to be delivered by non-specialists in mental health. METHODS: Health visitors were trained in CBC and post-training changes in counselling skills, clinical practice and costs were assessed. RESULTS: Following training health visitors showed improved counselling skills, and they carried out more mental health assessments, recorded mental symptoms more often and treated more women themselves. However, their mean number of contacts with depressed women did not change; and the number of urgent contacts diminished. Referrals to general practitioners did not increase but there was an increase in referrals to mental health services. Costs to health visitor practice did not increase. LIMITATIONS: Assessment of clinical practice was based on health visitor records. The study uses a 'before and after' design rather than randomisation of subjects. CONCLUSIONS: Training health visitors in CBC leads to improved counselling skills and corresponding changes in clinical practice, without increasing the costs of health visitor practice.     

Central abdominal fat and endogenous hormones during the menopausal transition

OBJECTIVE: To investigate the effect of endogenous hormone levels on central abdominal fat during the menopausal transition in a population-based cohort of Australian-born women. DESIGN: Prospective observational study. SETTING: Population-based sample. Body composition was assessed in the Royal Melbourne Hospital, and interviews were conducted at the patient's home. SUBJECT(S): One hundred two women from the Melbourne Women's Midlife Health Project. Data, physical measures, and blood were obtained by interview when the longitudinal study commenced (baseline) and at the time of the total body scan approximately 5 years later. Body composition was measured using dual-energy X-ray absorptiometry. INTERVENTION(S): None. MAIN OUTCOME MEASURES: Total body fat and central abdominal fat. RESULT(S): The 102 women were either premenopausal or in the early menopausal transition at baseline. At the time of their dual-energy X-ray absorptiometry scan, 31 were in the early menopausal transition, 22 were in the late menopausal transition, and 49 were postmenopausal. Multiple regression analysis found that total percentage of body fat was associated with weight measures, whereas central abdominal fat was also positively associated with baseline free T index (FTI) and with the increase in FTI since baseline. CONCLUSION(S): The major hormonal change associated with central adiposity during the menopausal transition is the increase in the FTI. This effect is significant even after allowing for baseline and final weight.     

Aging women with polycystic ovary syndrome who achieve regular menstrual cycles have a smaller follicle cohort than those who continue to have irregular cycles

OBJECTIVE: To examine whether follicle loss due to ovarian aging is responsible for the occurrence of regular menstrual cycles in aging women with polycystic ovary syndrome (PCOS), the size of the FSH-sensitive follicle cohort was estimated by the exogenous follicle-stimulating hormone ovarian reserve test (EFORT) and related to the follicle count as measured by ultrasound. DESIGN: Prospective study. SETTING: Reproductive endocrinology unit of an academic medical center. PATIENT(S): Twenty-seven aging women with PCOS (35.8-49.4 years): 20 with regular menstrual cycles and 7 with oligomenorrhea or amenorrhea. INTERVENTION(S): EFORT and transvaginal ultrasound. MAIN OUTCOME MEASURE(S): Baseline (cycle day 2, 3, or 4) FSH, androstenedione (A), T, E(2), and inhibin B levels, the E(2) and inhibin B increment after the EFORT, and the follicle count. RESULT(S): After correction for the body mass index (BMI), the inhibin B increment was higher in the irregular menstrual group, but the E(2) increment did not differ significantly between the two groups. Ultrasound showed a median follicle count of 8.5 (4.0-18.0) in women with regular menstrual cycles (n = 16), compared with 18.0 (8.0-35.0) in irregularly menstruating women (n = 7). The follicle count was significantly correlated to the FSH-induced E(2) increment (r = 0.656) as well as to the inhibin B increment (r = 0.654). The regularly menstruating group was significantly older, had a higher basal FSH concentration, and had lower androgens than the irregularly menstruating group. CONCLUSION(S): The smaller follicle count, the older age, the higher FSH concentration, and the lower FSH-induced inhibin B increment found in women with PCOS and a regular menstrual cycle confirm that a decrease in the size of the follicle cohort due to ovarian aging is largely responsible for the regular menstrual cycles in aging PCOS women.     

Infertility drugs and the risk of breast cancer: findings from the National Institute of Child Health and Human Development Women's Contraceptive and Reproductive Experiences Study

OBJECTIVE: To determine the association between infertility drug use and invasive breast cancer in a population-based case-control study. DESIGN: Multicenter case-control study. SETTING: Women aged 35 to 64 years in metropolitan Atlanta, Detroit, Los Angeles, Philadelphia, and Seattle. PATIENT(S): The 4,575 case patients had histologically confirmed primary invasive breast cancer. The 4,682 control subjects were women without breast cancer identified in the same geographic locations using randomized-digit dialing. INTERVENTION(S): A standardized questionnaire focusing on reproductive health and family history as well as use of oral contraceptives and other hormones and infertility drugs was administered to all subjects. Data on the type of breast cancer were also obtained. MAIN OUTCOME MEASURE(S): Odds ratios examining the association between use of various infertility drugs and invasive breast cancer. RESULT(S): Overall, a history of infertility drug use was not associated with the risk of developing breast cancer. Compared with women who never used any fertility medication, however, women using human menopausal gonadotropin (hMG) for > or = 6 months or for at least six cycles had a relative risk of breast cancer ranging between 2.7 to 3.8. CONCLUSION(S): Long-term use of certain infertility drugs could adversely affect risk of breast cancer. Additional confirmatory studies are needed.     

Oral contraceptives,tubal sterilization,and functional ovarian cyst risk

OBJECTIVE: To determine whether current contraceptive method affects functional ovarian cyst risk, with emphasis on oral contraceptives (OCs) and tubal sterilization. METHODS: We conducted a case-control study of 18-39-year-old health maintenance organization enrollees with a functional ovarian cyst diagnosed between January 1, and June 30, 1994, and age-matched female controls randomly selected from enrollment files. In-person interviews as well as medical and pharmacy records were obtained for 78% of cases and 82% of controls; these analyses were based on 392 cases and 623 controls. Odds ratios (ORs) calculated with unconditional logistic regression were used to estimate the risk of a functional ovarian cyst diagnosis associated with current contraceptive method. RESULTS: In multivariable analyses adjusting for age, education, number of live births, and reference year, the overall OR was 0.72 (95% confidence interval [CI] 0.53, 0.99) for current OC use, compared with use of nonsurgical nonhormonal contraception or no contraception. The risk associated with use of 35 microg ethinyl estradiol monophasic OCs (OR 0.69; 95% CI 0.44, 1.10) was slightly lower than that associated with less than 35 microg ethinyl estradiol monophasic (OR 0.79; 95% CI 0.43, 1.47) or multiphasic OCs (OR 0.76; 95% CI 0.49, 1.19). Women with tubal sterilization had a substantially increased risk of a functional ovarian cyst diagnosis (OR 1.70; 95% CI 1.05, 2.75) compared with women using nonhormonal or no contraception. CONCLUSION: Our findings suggest that low-dose OC use has little or no effect on functional ovarian cyst likelihood. The increased risks we found associated with tubal sterilization merit further investigation.     

Ureaplasma parvum and Ureaplasma urealyticum are detected in semen after washing before assisted reproductive technology procedures

OBJECTIVE: To investigate the prevalence of ureaplasmas in semen and washed semen and to explore their effect on semen andrology variables. DESIGN: Prospective study. SETTING: In vitro fertilization (IVF) unit of a private hospital. PATIENT(S): Three hundred forty-three men participating in an assisted reproductive technology (ART) treatment cycle. MAIN OUTCOME MEASURE(S): The prevalence of ureaplasmas in semen and washed semen tested by culture, polymerase chain reaction assays, and indirect immunofluorescent antibody assays. RESULT(S): Ureaplasmas were detected in 73 of 343 (22%) semen samples and 29 of 343 (8.5%) washed semen samples. Ureaplasmas adherent to the surface of spermatozoa were demonstrated by indirect immunofluorescent antibody testing. Ureplasma parvum serovar 6 (36.6%) and U. urealyticum (30%) were the most prevalent isolates in washed semen. A comparison of the semen andrology variables of washed semen ureaplasma positive and negative groups demonstrated a lower proportion of nonmotile sperm in men ureaplasma positive for washed semen. CONCLUSION(S): Ureaplasmas are not always removed from semen by a standard ART washing procedure and can remain adherent to the surface of spermatozoa.