Promptness of oxytocin administration for first-line treatment of postpartum hemorrhage: a national vignette-based study among midwives.

BACKGROUND: Postpartum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality worldwide. Midwives play a key role in the initial management of PPH. Uterotonic agents are widely used in its prevention and treatment, with oxytocin the first-line agent. Nonetheless, a standardized guideline for optimal dose and rate of administration has not been clearly defined. The aim of this study was to investigate French midwives' practices regarding first-line oxytocin treatment and the factors influencing its delayed administration. METHODS: This multicenter study was based on clinical vignettes of PPH management collected using an anonymous online questionnaire. A random sample of midwives from 145 maternity units in France from 15 randomly selected perinatal networks were invited to participate by email. The Previously validated case vignettes described two different scenarios of severe PPH. Vignette 1 described a typical immediate, severe PPH, and vignette 2 a less typical case of severe but gradual PPH They were constructed in three successive steps and included multiple-choice questions proposing several types of clinical practice options at each stage. For each vignette separately, we analyzed the lack of prompt oxytocin administration and the factors contributing to them, that is, characteristics of the midwives and organizational features of maternity units. Bivariate analysis and multivariable logistic regression analysis were applied. RESULTS: In all, 450 midwives from 87 maternity units provided complete responses. Lack of promptness was observed in 21.6% of responses (N = 97) in Vignette 1 and in 13.8% (N = 62) in Vignette 2 (p < .05). After multivariate analysis, the risk of delay was lower among with midwives working in university maternity hospitals (ORa 0.47, 95% 0.21, 0.97) and in units with 1500 to 2500 births per year (ORa 0.49, 95% CI 0.26, 0.90) for Vignette 1. We also noticed that delay increased with the midwives' years of experience (per 10-year period) (ORa 1.30, 95% CI 1.01, 1.69). CONCLUSIONS: This study using clinical vignettes showed delays in oxytocin administration for first-line treatment of PPH. Because delay in treatment is a major cause of preventable maternal morbidity in PPH, these findings suggest that continuing training of midwives should be considered, especially in small maternity units.

Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.

BACKGROUND: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment. AIM: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies). PATIENTS AND METHODS: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire. RESULTS: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69-97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease. CONCLUSION: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.

Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis.

OBJECTIVE: To evaluate long term efficacy of three iterative courses of three weekly intra-articular (IA) injections of NRD101 in the treatment of symptomatic knee osteoarthritis (OA). PATIENTS AND METHODS: A 1 year prospective, multicentre, randomised, double blind, placebo controlled study of 301 patients aged >50 years with painful and radiological medial knee OA. Patients were randomly assigned into three groups receiving: (1) three courses of three IA injections of hyaluronic acid (HA) + oral placebo; (2) IA injections of saline solution + diacerein 100 mg/day; (3) IA injections of saline solution + oral placebo. Demographic data and symptomatic criteria-pain, Lequesne's index, patient's global assessment of disease activity, percentage of painful days-were obtained during the study; primary structural criterion was JSW. Efficacy criteria were changes in pain VAS, joint space narrowing (JSN), and percentage of progressors (JSN >0.5 mm). An intention to treat analysis was used for symptomatic variables, and completer analysis for structural variables. RESULTS: Baseline characteristics were similar between the three groups. Mean (SD) improvement in pain VAS was clinically relevant (-33.9 (27.3), n = 301), but with no difference between the groups (p = 0.96). JSW deteriorated (-0.09 (0.55) mm, n = 277, p = 0.01), but with no difference between the groups (p = 0.82). Percentages of progressors were 17.7, 18.9, and 20.3% (p = 0.90), in groups 1, 2, and 3, respectively. CONCLUSION: A weak but statistically significant structural deterioration occurred over 1 year, together with clinically relevant symptomatic improvement in patients receiving oral drug and iterative IA injections. Symptomatic and/or structural effects for both this new HA compound and diacerein were not demonstrated.

Disability in adults with hip and knee arthroplasty: a French national community based survey.

OBJECTIVES: To compare levels of disability of people with and without hip and knee arthroplasty in a random national sample. METHODS: In 1999 a screening questionnaire to classify people into groups of increasing probabilities of disability was sent to 417 500 people; response rate 86%. The study population was obtained by a stratified randomisation, with a high sampling rate for the most severely disabled group and a minimum sampling rate for people without daily living restrictions. A computer assisted interview to assess levels of disability, dependence, and handicap was given to 21 760 people; response rate 78%. A weighting factor was applied to obtain estimates representative of the French population. The presence of chronic conditions, impairments, and disability was ascertained from the subjects' reports. RESULTS: The hip and knee arthroplasty group comprised 815 subjects in the sample, indicating an estimated 691 000 subjects (95% confidence interval (CI) 597 000 to 785 000) in the French non-institutionalised population. The prevalence of arthroplasty is estimated at 1.2%. After adjustments for confounding factors, activity limitations were greater among subjects with arthroplasty for the following activities: climbing stairs (odds ratio (OR)=4.0, 95% CI 2.8 to 5.8); walking distance (OR=3.4, 95% CI 2.5 to 4.6 for a walking distance less than 500 m); bending forward (OR=3.2, 95% CI 2.2 to 4.7); cutting toenails (OR=2.8, 95% CI 1.9 to 3.9); carrying (OR=2.6, 95% CI= 1.8 to 3.8); shopping (OR=2.1, 95% CI 1.5 to 2.9). CONCLUSIONS: This study would be useful to policy-makers considering population strategies for managing disabling arthritis.

Evaluating high dose therapy in Multiple Myeloma: use of quality-adjusted survival analysis.

PURPOSE: To incorporate quality-of-life considerations in assessing high dose therapy (HDT) for patients with Multiple Myeloma (MM). PATIENTS AND METHODS: A quality-adjusted survival analysis. using the quality-adjusted time without symptoms or toxicity (Q-TWiST) method, was applied to two randomized clinical trials conducted in patients with MM which compared randomized assignment to HDT vs. conventional chemotherapy (CCT) alone (MAG91) or followed by HDT (MAG90). Treatment benefit in terms of mean Q-TWiST was assessed through threshold utility analyses, i.e., sensitivity analyses of the choice of the utility coefficients over all possible values of utility weights. RESULTS: In both trials, results slightly favored the first-line HDT group over the first-line CCT group, with an average gain in TWiST of about 5.5 months over the 58 month-median follow-up period (27.8 vs. 22.3 months, respectively) in the MAG90 trial and 5.8 months over the 56 month-median follow-up period (19.1 vs. 13.3 months, respectively) in the MAG91 trial. The utility threshold analyses revealed that the first-line HDT group had a statistically increased mean quality-of-life adjusted time compared to the other group for a broad range of utility coefficient values. CONCLUSION: The development of such understandable and intuitive measures of expressing the relative benefit of complex treatment strategies is expected to be used in clinical decision making in the near future.

[Non-drug treatments for osteoarthritis]. / Traitements non pharmacologiques de l'arthrose.

PHYSICAL EXERCISE: Several epidemiological studies and therapeutic trials have provided concordant evidence on the beneficial effect of physical exercise in degenerative joint disease despite methodological limitations and the higher level of proof for knee disease than hip disease. In addition, programs which led to beneficial effects were intensive programs, initiated in a hospital setting and continued in the patient's home. WEIGHT LOSS: Body weight has a determining effect on degenerative bone and joint disease, particularly when the knee is involved. It has been demonstrated that the amount of weight loss depends on the quality of the physical exercises performed. WALKING AIDS: Different walking aids, crutches, special soles and shoes, splints and braces can be proposed for patients with degenerative joint disease. These aids constitute an integral part of the non-drug therapeutic approach to patient treatment.