NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial.

OBJECTIVE: To compare NASHA hyaluronic acid gel as single-injection intra-articular (IA) treatment for knee osteoarthritis (OA) against methylprednisolone acetate (MPA). DESIGN: This was a prospective, multi-centre, randomized, active-controlled, double-blind, non-inferiority clinical trial. A unique, open-label extension phase (OLE) was undertaken to answer further important clinical questions. Subjects with painful unilateral knee OA were treated and followed for 26 weeks (blinded phase). All patients attending the clinic at 26 weeks were offered NASHA treatment, with a subsequent 26-week follow-up period (extension phase). The primary objective was to show non-inferiority of NASHA vs MPA in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain responder rate (percentage of patients with ≥40% improvement from baseline in WOMAC pain score and an absolute improvement of ≥5 points) at 12 weeks. RESULTS: In total, 442 participants were enrolled. The primary objective was met, with NASHA producing a non-inferior response rate vs MPA at 12 weeks (NASHA: 44.6%; MPA: 46.2%; difference [95% CI]: 1.6% [-11.2%; +7.9%]). Effect size for WOMAC pain, physical function and stiffness scores favoured NASHA over MPA from 12 to 26 weeks. In response to NASHA treatment at 26 weeks, sustained improvements were seen in WOMAC outcomes irrespective of initial treatment. No serious device-related adverse events (AEs) were reported. CONCLUSIONS: This study shows that single-injection NASHA was well tolerated and non-inferior to MPA at 12 weeks. The benefit of NASHA was maintained to 26 weeks while that of MPA declined. An injection of NASHA at 26 weeks conferred long-term improvements without increased sensitivity or risk of complications. STUDY IDENTIFIER: NCT01209364 (www.clinicaltrials.gov).

[Monitoring of vancomycin in pediatrics]. / Suivi des concentrations sériques de la vancomycine en pédiatrie.

OBJECTIVES: The authors wanted to determine if the current local practice (initial prescription and monitoring) in pediatrics allowed reaching vancomycin therapeutic concentrations. PATIENTS AND METHODS: Thirty patients that had received vancomycin for at least five days with at least one evaluation of serum concentration, at the Sainte-Justine university hospital center, were retrospectively studied. Vancomycin trough and peak levels were analyzed. RESULTS: The values of vancomycin serum concentration were within therapeutic ranges (local standards of 5 to 10mg/L for trough level and 20 to 40 mg/L for peak level) in 60% and 33% of cases at the fifth day of treatment for trough and peak levels, respectively. CONCLUSION: The current practice does not allow reaching vancomycin serum concentrations in the target range. Using a wider range for the trough values could be considered.

Gas production and migration in landfills and geological materials.

Landfill gas, originating from the anaerobic biodegradation of the organic content of waste, consists mainly of methane and carbon dioxide, with traces of volatile organic compounds. Pressure, concentration and temperature gradients that develop within the landfill result in gas emissions to the atmosphere and in lateral migration through the surrounding soils. Environmental and safety issues associated with the landfill gas require control of off-site gas migration. The numerical model TOUGH2-LGM (Transport of Unsaturated Groundwater and Heat-Landfill Gas Migration) has been developed to simulate landfill gas production and migration processes within and beyond landfill boundaries. The model is derived from the general non-isothermal multiphase flow simulator TOUGH2, to which a new equation of state module is added. It simulates the migration of five components in partially saturated media: four fluid components (water, atmospheric air, methane and carbon dioxide) and one energy component (heat). The four fluid components are present in both the gas and liquid phases. The model incorporates gas-liquid partitioning of all fluid components by means of dissolution and volatilization. In addition to advection in the gas and liquid phase, multi-component diffusion is simulated in the gas phase. The landfill gas production rate is proportional to the organic substrate and is modeled as an exponentially decreasing function of time. The model is applied to the Montreal's CESM landfill site, which is located in a former limestone rock quarry. Existing data were used to characterize hydraulic properties of the waste and the limestone. Gas recovery data at the site were used to define the gas production model. Simulations in one and two dimensions are presented to investigate gas production and migration in the landfill, and in the surrounding limestone. The effects of a gas recovery well and landfill cover on gas migration are also discussed.

Effects of dissipation on a superconducting single electron transistor.

We measure the effect of dissipation on the minimum zero-bias conductance, G(min)0, of a superconducting single electron transistor (sSET) capacitively coupled to a two-dimensional electron gas (2DEG) in a GaAs/AlGaAs heterostructure. Depleting the 2DEG with a back gate voltage decreases the dissipation experienced by the sSET in situ. We find that G(min)0 increases as the dissipation is increased or the temperature is reduced; the functional forms of these dependences are compared with the model of Wilhelm et al. in which the leads coupled to the sSET are represented by lossy transmission lines.

Clindamycin with primaquine vs. Trimethoprim-sulfamethoxazole therapy for mild and moderately severe Pneumocystis carinii pneumonia in patients with AIDS: a multicenter, double-blind, randomized trial (CTN 004). CTN-PCP Study Group.

This double-blind, randomized, multicenter trial compared clindamycin/primaquine (Cm/Prq) with trimethoprim-sulfamethoxazole (TMP-SMZ) as therapy for AIDS-related Pneumocystis carinii pneumonia (PCP). Forty-five patients received clindamycin (450 mg four times daily [q.i.d.]) and primaquine (15 mg of base/d); 42 received TMP-SMZ (320 mg/1,600 mg q.i.d. if weight of > or = 60 kg or 240 mg/1,200 mg q.i.d. if weight of < 60 kg) plus placebo primaquine. Overall, the efficacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 76% vs. 79%, respectively); Cm/Prq was associated with fewer adverse events (P = .04), less steroid use (P = .18), and more rashes (P = .07). These differences were even greater for patients with PaO2 of > 70 mm Hg (P = .02, P = .04, and P = .02, respectively). For patients with PaO2 of < or = 70 mm Hg (23 Cm/Prq recipients and 21 TMP-SMZ recipients), the efficacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 74% vs. 76%, respectively); Cm/Prq was associated with similar adverse events (P = .57), steroid use (P = .74), and rashes (P = .78). This trial confirms that Cm/Prq is a reasonable alternative therapy for mild and moderately severe PCP.

Managed care.

Many say 1994 will be the year for health-care reform, but those in the thick of the current health delivery system know that 1993 has already brought many sweeping reforms. These reforms will be studied, refined, and tailored for the national plan. What types of reforms are laboratorians seeing now? What kinds of changes can we expect in the upcoming months and years? We asked laboratory managers those very questions. The result has been a two-part As We See It. In the last CLMR, we covered physician partnerships and the system laboratory. In this issue, we will cover alliances with hospitals and laboratory cost reductions as we ask: What can the laboratory community expect from a managed-care environment.

Managed care.

Health-care reform has become a national mandate. Managed care and managed competition have been reinforced by the Clinton health-care reform plan. What type of health-care delivery system can laboratory managers expect to be part of in the near future? We asked laboratory managers who are currently involved in those types of systems. The result is a two-part As We See It. In part one, we will cover physician partnerships and the system laboratory as we ask: What can the laboratory community expect from a managed-care environment?

Recruiting and retaining medical technologists.

Personnel recruitment and retention is one of the most challenging facets of management. Despite turnover rates, identifying and retaining good employees should be foremost on any managerial agenda. An effective employee recruiting/relations program enhances the overall productivity of an operation by addressing concerns at staff level, often considered the core of activity. In this issue, we asked our respondents: What methods do you use to recruit and retain medical technologists?

Running gait impulse asymmetries in below-knee amputees.

In running, large gait asymmetry is expected due to the inability of the foot prosthesis to comply with the kinematic demands and produce a powerful plantarflexion moment. In this work, interlimb asymmetry in below-knee (BK) amputee running gait was assessed for one rigid and three flexible keel prostheses, using vertical and anteroposterior ground reaction forces and respective impulses. Nine BK amputees and 6 controls participated in this study. The running speed was monitored by two light sensitive detectors while the ground reaction forces were measured with a Kistler force plate. Between the prosthetic side and the sound limb the impulse indicator showed greater asymmetry than the force. Interlimb asymmetry was very much present in all types of prosthesis tested but is less pronounced in the flexible keel prostheses. In the latter, the asymmetry may be associated with the force-time history modulation rather than its magnitude alone. Generally, the impulses better describe interlimb asymmetry and the forces allow a greater discrimination between prosthetic foot types.

[Determinants of satisfaction with medical prenatal care in Quebec women]. / Déterminants de la satisfaction à l'égard du suivi médical pré-natal chez des femmes québécoises.

This study aims at identifying determinants of satisfaction with medical care during pregnancy, a topic little explored until now. 937 women from the Montreal area answered a mailed questionnaire 4 to 7 months after giving birth. Results show a high level of satisfaction with prenatal care among respondents. Multiple regression analysis reveals that information variables emerge as the main determinants of satisfaction. In fact, not having received desired information appears as the strongest predictor; information pertaining to the delivery process is most often cited by women. The other predictors are events happening during the delivery process. Contrary to findings from other studies, sociodemographic data and characteristics of the physicians do not predict satisfaction. The discussion suggests some guidelines for the measurement of satisfaction with prenatal care as well as implications for practice.

[Deinstitutionalization, the patients, the families and women: interests to reconcile]. / La désinstitutionnalisation, les malades, les familles et les femmes: des intérêts à concilier.

Deinstitutionalization is very demanding for families. Forced to fill in the gaps of the system, their role is one of creating a therapeutic environment while receiving little support from government service organizations. Cohabitation often leads to difficult relations between a patient and his or her family. In such a context, a large proportion of families experience problems in their attempt to fill their parental role. Women are more affected by this situation seeing they provide a large part of the emotional support to chronically ill mental patients and maintain the contact with service organizations. Also, they must confront professionals who often judge them as overprotective or responsible if the patient is their own child. The authors definitely agree that collective responsibility must complement family responsibility to ensure the respect of patients', families', and women's rights.

The components of women's satisfaction with maternity care.

For a better understanding of how women's satisfaction with maternity care is affected, a representative sample of 1790 women from the Montreal area who had delivered four to seven months earlier were mailed a postal questionnaire; 938 (52.4%) completed and returned it. With factor analysis, we determined five dimensions to women's satisfaction: (a) the delivery itself, (b) medical care, (c) nursing care, (d) information received and participation in the decision-making process, and (e) physical aspects of the labor and delivery rooms. Multiple regression analysis was used to determine explicative factors for each of these dimensions of satisfaction. Items relative to the delivery process such as pain intensity, complications, and length of labor were the most important for the delivery experience itself. Participation in the decision-making process was the first component of satisfaction with medical care. Information received appeared to be the major component of their satisfaction with nursing care. The physical environment did not affect women's satisfaction with obstetric care.

[Responsibility of families and women in home-care of the elderly : a policy of non-committment or support from the State ?]. / La responsabilité des familles et des femmes dans le maintien à domicile des personnes âgées : une politique de désengagement ou de soutien de l'État.

SUMMARY After having shown the importance given to the theme of disengagement of families towards the elderly in the home care policy, the author proceeds to demonstrate that it is a myth. In fact, several studies shed light on the extent of family networks assisting the elderly as well as the central role played by women. This form of assistance has several repercussions on the life of those offering help and women are particularly vulnerable in this respect. The article then underscores the impact of Quebec's home care policy on family members offering assistance. Finally, the author questions the future of this policy by emphasizing certain demographic and social trends.

Differences in the severity of disturbance of behaviors in children receiving inpatient and outpatient psychiatric treatment.

This study was conducted to determine if there are differences in the severity of disturbance of behaviors exhibited by children receiving inpatient psychiatric treatment and those receiving outpatient psychiatric treatment based on their parents' judgments of the frequency of occurrence of those behaviors. The same behaviors were found to exist in both treatment groups, but the severity of disturbance of those behaviors in the inpatient sample was significantly greater than in the outpatient sample. The scale used in this study was found to be a valid and useful instrument for predicting inpatient and outpatient status of children. Pratice and research implications of this study are also discussed.