Standard methods based on last menstrual period dates misclassify and overestimate US preterm births.

OBJECTIVE: To compare number of US preterm births based on obstetric versus last menstrual period (LMP) estimates and evaluate their correlations with clinical risk indicators associated with prematurity. STUDY DESIGN: Preterm births were assessed from LMP, per standard practice, and, separately, from obstetric estimates using the 2012 Natality Public Use File. Percentages of infants with neonatal intensive care unit (NICU) admission and low birth weight (LBW) were calculated. RESULT: More births were <37 weeks gestational age (GA) by reported LMP (11.4%) versus obstetric estimates (9.5%). Among infants preterm by LMP, but born at 37-41 weeks by obstetric estimates, there were 5.7% NICU admission and 7.7% LBW rates versus 25.2% and 35.4%, respectively, of those preterm by obstetric estimates but born 37-41 weeks by LMP assessments. CONCLUSION: Obstetric estimates provide the most clinically relevant estimates of US preterm births. Assessments calculated from LMP alone may overestimate prematurity incidence by ~20%.

Activity of fludarabine in previously treated Waldenström's macroglobulinemia: a report of 71 cases. Groupe Coopératif Macroglobulinémie.

PURPOSE: There is no consensus on the treatment of patients with Waldenström's macroglobulinemia (WM) who develop primary or secondary resistance to frontline therapies. We report our experience on the activity and toxicity of fludarabine in 71 patients with WM resistant to prior chemotherapy regimens. PATIENTS AND METHODS: From January 1991 to June 1995, 71 patients were included in this retrospective study. The median age, median time from diagnosis to treatment, median immunoglobulin M (IgM) level, and median number of previous treatments were 68 years (range, 42 to 81), 5.9 years (range, 0.6 to 20), 35 g/L (range, 5 to 126), and two (range, one to four), respectively. RESULTS: Seventy-one patients received a median of six courses of fludarabine. Twenty-one (30%) responded with a partial response and 50 (70%) were considered as treatment failures. Forty-six patients died: 10 in the responder group and 36 in the failure group. Twenty-five patients were alive with a median follow-up time of 34 months. The overall median survival time of all treated patients was 23 months. The time to treatment failure was 32 months. The only factor that favorably influenced the response to fludarabine was a longer interval between the first treatment and the start of fludarabine. Pretreatment factors associated with shorter survival in the entire population were hemoglobin level less than 95 g/L (P = .02) and platelet count less than 75 x 10(9)/L (P = .02). CONCLUSION: The responses rate in this population with a poor prognosis is close to that reported in shorter series. Patients with WM who are resistant to alkylating agents should be identified early, so that salvage therapy with nucleoside analogs can be started without delay.

Efficacy and safety of avocado/soybean unsaponifiables in the treatment of symptomatic osteoarthritis of the knee and hip. A prospective, multicenter, three-month, randomized, double-blind, placebo-controlled trial.

One of the objectives of symptomatic slow-acting drugs for osteoarthritis is to reduce the need for drugs with a less favorable safety profile, mainly analgesics and nonsteroidal antiinflammatory drugs (NSAIDs). We conducted a three-month, prospective, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy of avocado/soybean unsaponifiables in terms of NSAID use reduction. Patients with primary femorotibial or hip osteoarthritis (OA) (ACR criteria and Kellgren-Lawrence radiological stage IB, II, or III) of at least six months' duration with regular pain for more than three months requiring therapy with NSAID (visual analog scale score > or = 25 mm and Lequesne's index on therapy > or = 4) were given one capsule per day of avocado/soybean unsaponifiables or a placebo for three months. During the first 45 days, patients in both groups were also given one of seven predefined NSAIDs. The primary efficacy criteria was the rate of patients taking back a NSAID and the delay before re-intake. Secondary efficacy criteria were the total dose of NSAID, overall ratings by the patient and by the physician, the visual analog scale pain score and the functional index. Of the 164 included patients, 163 were evaluable, 80 in the active drug group and 83 in the placebo group. Mean age was 62.9 +/- 8.8 years. The diagnosis was femorotibial OA in 101 patients and hip OA in 62. Data were collected on day 45 in 153 patients (77 on the active drug and 76 on the placebo). The number of patients who took back NSAID therapy was significantly smaller in the group treated by avocado/soybean unsaponifiables (33; 43.4%) than in the placebo group (53; 69.7%) (P < 0.001). Also, beyond day 54, the time spent off NSAID therapy was shorter in the placebo group. The functional index showed a significantly greater improvement in the active drug group (-2.3 +/- 2.6) than in the placebo group (-1.0 +/- 2.6) (P < 0.01). Pain scores over time were similar in the two groups. Overall patient ratings were significantly better in the active drug group (P < 0.01). Safety was oggd in both groups. After six weeks, avocado/soybean unsaponifiables reduced the need for NSAID in patients with lower limb OA.

Phase II trial of fludarabine monophosphate as first-line treatment in patients with advanced follicular lymphoma: a multicenter study by the Groupe d'Etude des Lymphomes de l'Adulte.

PURPOSE: Fludarabine monophosphate (FAMP) is a major drug in the treatment of chronic lymphocytic leukemia and showed efficacy in selected groups of patients with low-grade lymphomas, most of them pretreated. The aim of this trial was to assess the efficacy and the toxicity of FAMP in untreated patients with follicular lymphoma. PATIENTS AND METHODS: Fifty-four untreated patients with advanced follicular lymphoma were treated with intravenous (i.v.) fludarabine at a dose of 25 mg/m2/d during 5 days every 4 weeks, to a maximum of nine cycles. RESULTS: The toxicity of the drug was mild, mainly granulocytic. Granulocytopenia > or = 3 (World Health Organization [WHO]) was observed during 48 of 328 cycles (14.6%) and in 22 of 53 (41%) patients assessable for toxicity. Fludarabine had to be stopped prematurely because of toxicity in nine patients: marrow toxicity in five, peripheral neuropathy in two, and interstitial pneumonitis and hepatitis in one patient each. Among 49 patients assessable for response, the overall response rate was 65% and the complete response (CR) rate 37%. The median progression-free survival interval for all patients was 13.6 months. CONCLUSION: These results confirm that fludarabine is active when used as first-line treatment in patients with follicular lymphoma and has a low toxicity rate. It may be used as single treatment in elderly patients. Associations of fludarabine with other drugs active against follicular lymphoma need to be determined.

Validation of an algofunctional index for osteoarthritis of the hand.

Although hand osteoarthritis is common, it has been the focus of few therapeutic trials. In addition to the problems raised by clinical trials in osteoarthritis in general and to the difficulties due to the unforeseeable course of osteoarthritis of the trapezometacarpal and finger joints, the lack of a clinical tool for assessing pain and function over time is an additional obstacle. We propose an algofunctional index designed for evaluation and symptomatic follow-up of patients with digital osteoarthritis. The index is based on a physician-administered questionnaire on 10 daily activities involving the hands. The patient is asked to answer each item using a 4-point verbal scale, from "possible without difficulty" (0) to "impossible" (3 points); thus, total scores range from 0 to 30. This index has been used in a few clinical placebo-controlled trials and was found sensitive to change. The aim of this study was to assess the metrological qualities of this index, including consistency (internal and external), sensitivity and specificity (by scoring the index in different groups of subjects), intra-observer reproducibility, and ease of use. Three hundred patients were recruited by 25 rheumatologists: 100 had a painful attack of digital and/or trapezometacarpal osteoarthritis (mean age: 64.9 years) with a score of more than 40 mm on a visual analog scale for overall pain severity (mean: 57.3 +/- 14 mm), 100 had "inactive" hand osteoarthritis (mean age 67.0 years), and 100 had no diseases of the upper limbs. Specificity/sensitivity: the mean index score was 12.41 +/- 5.41 in patients with painful OA, 4.28 +/- 3.87 in "inactive" cases, and 0.59 +/- 1.23 in controls. External consistency: the overall mean score was well correlated with pain severity: r = 0.49 (p < 0.001). Internal consistency: principal component analysis identified a primary axis responsible for 44.2% of the variance and two secondary axes each responsible for slightly more than 9% of the variance. None of the questions seemed redundant. Intra-observer reproducibility: two evaluations done one hour apart in symptomatic patients yielded the following scores: 12.32 +/- 5.41 and 12.5 +/- 5.51 (correlation: 0.95; mean difference: 0.17 +/- 1.64; coefficient of variation: 9.32%). Kappa values for both measurements of each item ranged from 0.68 to 0.87. Ease of use: mean time needed to determine the score 2.5 +/- 2 min. The scoring process was considered simple by 100% of investigators and easy/very easy by 98% of patients.(ABSTRACT TRUNCATED AT 400 WORDS)

[Sexually transmitted diseases in free sexual practice. Epidemiological aspects]. / Les maladies sexuellement transmissibles en pratique libérale. Aspects épidémiologiques.

One of the major public health preoccupations at present is the incidence of sexually transmissible diseases and their consequences for fertility. At present there is a programme of combined research by the National Institute of Health and the Medical Research (INSERM U 292) and the Director-General of Health (DGS) and the French Committee for Education in Health Matters (CFES). The object of the exercise is to produce a programme for preventing sexually transmissible diseases and then to put in into action in order to find out how practical it is. The programme consists of two phases, the first which has already been completed was to assess how practical the exercise is, and the second phase which is the active pursuit of the enquiry in a random attempt to change things, and this started in November 1986. The first phase tried to test the methods and see whether they were useful forms of research, and also to serve as a base for the programme of prevention. This consists in looking twice a year at the incidence of discharges in men and in women and the characteristics of the patients who are affected. The consultants were a representative sample of general practitioners who work in the Hauts-de-Seine Department. They gave the information voluntarily. There were two measures carried out in the same region of France. The first was informing the public and making the professionals aware of the situation.(ABSTRACT TRUNCATED AT 250 WORDS)

[Is the IUD a risk to the future fertility of nulliparas?]. / Le sterilet menace-t-il vraiment la fertilite ulterieure des nullipares.

PIP: Use of IUDs is limited in developed countries because of perceived threats to future fertility, especially among nulliparas. These fears, shared by most practitioners, led to termination of most IUD sales in the US after July 1986. This review summarizes recent epidemiologic studies that confirm the increased risk of salpingitis and infertility in IUD users. The incidence of salpingitis has increased significantly and continuously over the past 20 years as a result of the development of sexually transmitted diseases. These infections may pass through the cervix and ascend to the tubes, where their sequelae include alteration of tubal function. The IUD is a risk factor for tubal infection because it favors ascending propagation of cervical infections. Studies in the US and Sweden indicate that IUD users have a 3 to 9 times higher risk of salpingitis than do nonusers. Studies in Lund, Sweden, and Seattle, USA, have demonstrated a significantly higher risk of salpingitis and infertility among nulliparas. Studies indicating increased risk of salpingitis among nulliparas are often criticized on methodological grounds for poor control of age factors, but it is known that young women (who are often nulliparas) are more exposed to the risk of salpingitis. The 1st studies suggesting a link between salpingitis and IUDs were criticized on 2 grounds: 1) that the risk of salpingitis varies according to the type of IUD and 2) that the risk of salpingitis in IUD users should be measured in terms of women not using any contraception, since hormonal methods are now known to protect against salpingitis. But studies have shown an increased risk of salpingitis even in Sweden, where the Dalkon Shield, associated with particularly high rates of salpingitis, was never marketed. Estimates of the relative risk of salpingitis among IUD users compared to women not using any contraception have already been made and range from 1.5 to 3. The evidence indicated that IUDs are a risk factor for salpingitis and consequently a threat to future fertility. An even higher risk among nulliparas appears reasonable but is controversial on methodological grounds. IUD use may sometimes be appropriate for older married women with stable sex lives for whom the vascular risks of hormonal methods are increasing. IUD use is contraindicated among young nulliparas because of the possibility of infertility.^ieng

Community prevention of STDs and their complications: methodological issues.

PIP: Sexually transmitted diseases (STD) remain significant public health problems due to their increasing incidence and longterm sequelae. Prevention of STD is an important public health goal. However, there are several methodological problems encountered by such programs. Correct determination of the incidence of STD is hampered by difficulties sampling populations and uncertainty in defining the diseases in question. Random population surveys are invalidated by low response rates. Registry of all STD cases is difficult due to the large number of institutions operating independently, and the number of patients who treat themselves without coming in contact with physicians. A solution may be to determine the incidence among patients approaching primary care physicians and extrapolating to the general population. This method has been validated in 3 French studies. Defining what constitutes a sexually transmitted disease is essential for accurate statistics. Physicians participating in surveys should be provided with checklists of diagnoses included and with standards for accurate diagnosis. A program to prevent STD is currently being tested in 6 French regions. Interventions include dissemination of information concerning STD to high risk groups via mass media, and to physicians, free medical tests and consultations and examination of prostitutes. The incidence of STD before and after intervention will be determined by visits to randomly selected physicians. Effects will be compared to control areas without the intervention. Possible sources of bias include other factors that may affect the number of non-STD visits, inability to detect effects on mild cases that do not present to physicians, and insufficient numbers of cases to arrive at statistical significance. A preliminary study was completed, demonstrating the feasibility of this study design.^ieng

[Frequency of vulvovaginal infections in independent practice]. / Fréquence des infections vulvovaginales en médecine libérale.

In the autumn of 1983 a representative sample of 78 gynaecologists practising independently were asked about the incidence and the bacteriological diagnosis of vulvovaginal infections in their practices. From this enquiry one can estimate that between 1 and 1.3% of French women who were over 18 years of age saw their gynaecologists complaining of vulvovaginal infections in the months of September and October 1983. The organisms that were most frequently found on bacteriological examination were candida (49%), non-specific non-pathogenic germs (47%) and trichomonas (20%).