Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures : a randomised double-blind placebo-controlled trial

Background: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures despite limited evidence to support its use. The primary aim of this study was to determine its short-term efficacy and safety in this patient population.

Methods: In a multicentre randomized placebo-controlled trial, participants with one or two painful osteoporotic vertebral fractures < 12 months duration confirmed active by MRI were randomly assigned, stratified by center, gender and duration of symptoms (< or ≥ 6 weeks), to receive vertebroplasty or sham treatment. Primary outcome was overall pain (0–10 scale) at 3 months. Participants, investigators (other than the interventional radiologist) and outcome assessors were blinded to treatment assignment.

Results: 78 participants were enrolled and 73 (36/38 active, 37/40 placebo, 94%) completed 3-month follow up. Vertebroplasty did not show any statistically significant advantage in any measured outcome with 95% confidence intervals indicating no plausible practically important benefits of vertebroplasty over placebo. At 1 week, 1 and 3 months, there were significant improvements in overall pain in both treatment groups (mean improvement (SD): 1.5 (2.5), 2.1 (2.8), 2.3 (2.6), and 1.7 (3.3), 2.5 (2.9), 1.9 (3.4) in the active and placebo groups respectively). Similar improvements in both groups were observed for night and rest pain, function, quality of life and perceived improvement. Eight incident clinical vertebral fractures (3 active, 5 placebo) occurred during 3-month follow up.

Conclusion: We found no evidence of a beneficial effect of vertebroplasty over sham treatment for painful osteoporotic vertebral fractures, 1 week, 1 and 3 months following treatment. [Australian Clinical Trial Register number, ACTRN012605000079640]

Assessing the efficacy and standardization potential of five competing venture capital investment evaluation approaches

The research objective behind this article was to perform a critical evaluation and comparison of five representative business plan evaluation aids (BPEAs) to facilitate constructive discussion of the proposition that greater standardization of venture capital decision-making might be both desirable and possible. The five BPEAs were systematically compared using a structured, taxonomic process. The evidence of this investigation suggests a clear superiority of BPEAs that are based on the researched attributes of successful ventures and use actuarial modeling. Discussion centered on the importance of using BPEAs in a quest for greater consistency during venture capital investment decision-making.

Violent offending : the efficacy of a unitary and transtheoretical intervention

Examines "best practice" in reducing recidivism. Compares two interventions for violent offenders, and examines whether their different theoretical orientations (unitary or transtheoretical) affected program efficiency. Although the transtheoretical intervention was more efficacious, insufficient adherence to best practice principles within implementation of both programs significantly impinged upon program success.

The efficacy of using e-mail when researching inclusive teaching practices used by male academics

The paper describes work-in-progress and reflects upon a small research project, ‘A Small Study of Male Academics and Their Inclusive Teaching Strategies’, in which the author trialed the use of e-mail communication as a medium for having repeated conversations with a number of male academics about their inclusive teaching practices. This forms a small part of a larger study concentrating on the non-mainstream leadership practices of male academics.

The study met with mixed results: on one hand, it provided an opportunity for the respondents to express how they teach inclusively; on the other, the study made it apparent that the use of e-mails alone did not facilitate communication with the respondents. The implication for research of a sensitive nature is to ensure that the communication is primarily of a personal, face-to-face nature with the use of e-mails providing a complementary, rather than a primary, means of data gathering.

HIV-1 vaccine development : tackling virus diversity with a multi-envelope cocktail

A major obstacle to the design of a global HIV-1 vaccine is viral diversity. At present, data suggest that a vaccine comprising a single antigen will fail to generate broadly reactive B-cell and T-cell responses able to confer protection against the diverse isolates of HIV-1. While some B-cell and T-cell epitopes lie within the more conserved regions of HIV-1 proteins, many are localized to variable regions and differ from one virus to the next. Neutralizing B-cell responses may vary toward viruses with different i) antibody contact residues and/or ii) protein conformations while T-cell responses may vary toward viruses with different (i) T-cell receptor contact residues and/or (ii) amino acid sequences pertinent to antigen processing. Here we review previous and current strategies for HIV-1 vaccine development. We focus on studies at St. Jude Children's Research Hospital (SJCRH) dedicated to the development of an HIV-1 vaccine cocktail strategy. The SJCRH multi-vectored, multi-envelope vaccine has now been shown to elicit HIV-1-specific B- and T-cell functions with a diversity and durability that may be required to prevent HIV-1 infections in humans.

HIV vaccine rationale, design and testing

A central obstacle to the design of a global HIV vaccine is viral diversity. Antigenic differences in envelope proteins result in distinct HIV serotypes, operationally defined such that antibodies raised against envelope molecules from one serotype will not bind envelope molecules from a different serotype. The existence of serotypes has presented a similar challenge to vaccine development against other pathogens. In such cases, antigenic diversity has been addressed by vaccine design. For example, the poliovirus vaccine includes three serotypes of poliovirus, and Pneumovax® presents a cocktail of 23 pneumococcal variants to the immune system. It is likely that a successful vaccine for HIV must also comprise a cocktail of antigens. Here, data relevant to the development of cocktail vaccines, designed to harness diverse, envelope-specific Bcell and T-cell responses, are reviewed.

Multi-envelope HIV-1 vaccine devoid of SIV components controls disease in macaques challenged with heterologous pathogenic SHIV

A central obstacle to the design of a global HIV-1 vaccine is virus diversity. Pathogen diversity is not unique to HIV-1, and has been successfully conquered in other fields by the creation of vaccine cocktails. Here we describe the testing of an HIV-1 envelope cocktail vaccine. Six macaques received the vaccine, delivered by successive immunizations with recombinant DNA, recombinant vaccinia virus and recombinant envelope proteins. Following vaccination, animals developed a diversity of anti-envelope antibody binding and neutralizing activities toward proteins and viruses that were not represented by sequence in the vaccine. T-cells were also elicited, as measured by gamma-interferon production assays with envelope-derived peptide pools. Vaccinated and control animals were then challenged with the heterologous pathogenic SHIV, 89.6P. Vaccinated monkeys experienced significantly lower virus titers and better maintenance of CD4+ T-cells than unvaccinated controls. The B- and T-cell immune responses were far superior post-challenge in the vaccinated group. Four of six vaccinated animals and only one of six control animals survived a 44-week observation period post-challenge. The present report is the first to describe pathogenic SHIV disease control mediated by a heterologous HIV-1 vaccine, devoid of 89.6 or SIV derivatives.

MUSTe method for quantifying virtual environment training system efficacy

In the current era increased attention and interest of utilizing advanced computer technologies for training and education at all managerial levels and functional areas is apparent. One of such technologies, virtual environment (VE), is perceived to be effective in enhancing human abilities to learn abstract concept and complex procedural tasks. Despite its adaptation for training and fast-paced technological advancements, ways in which to evaluate efficacy of such technology are unclear. We have approached this problem by developed a new evaluation method focus on cognitive, affective and skillbased learning dimensions, based on traditional usability evaluation methods but tailored to specifically suit for the quantification of 3D VE system. We first describe the construct of the new method and then report a study utilizing the method in the context of quantifying a VE efficacy in an object assembly task. At last, we discuss the implications of such a method.

Identification of depression in diabetes the efficacy of PHQ-9 and HADS-D

Background
Clinical guidelines advise screening for depression in patients with diabetes. The Patient Health Questionnaire (PHQ-9) and the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) are commonly used in primary care.

Aim
To compare the efficacy of HADS-D and PHQ-9 in identifying moderate to severe depression among primary care patients with type 2 diabetes.

Design of study
Self-report postal survey, clinical records assessed by GPs.

Setting
Seven metropolitan and rural general practices in Victoria, Australia.

Method
Postal questionnaires were sent to all patients with diabetes on the registers of seven practices in Victoria. A total of 561 completed postal questionnaires were returned, giving a response rate 47%. Surveys included demographic information, and history of diabetes and depression. Participants completed both the PHQ-9 and HADS-D. Clinical data from patient records included glycosylated hemoglobin (HbA1c) levels and medications.

Results
The proportion of the total sample completing HADS-D was 96.8% compared with 82.4% for PHQ-9. Level of education was unrelated to responses on the HADS-D but was related to completion of the PHQ-9. Using complete data (n = 456) from both measures, 40 responders showed HADS-D scores in the moderate to severe range, compared with 103 cases identified by PHQ-9. Only 35 cases were classified in the moderate to severe category by both the PHQ-9 and HADS-D. Items with the highest proportions of positive responses on the PHQ-9 were related to tiredness and sleeping problems and, on the HADS-D, feeling slowed down.

Conclusion
It may be that the items contributing to the higher prevalence of moderate to severe depression using the PHQ-9 are due to diabetes-related symptoms or sleep disorders.

Alcohol expectancies and drinking refusal self-efficacy mediate the association of impulsivity with alcohol misuse

Background: Recent work suggests that 2 biologically based traits convey risk for alcohol misuse: reward sensitivity ⁄ drive and (rash) impulsiveness. However, the cognitive mechanisms through which these traits convey risk are unclear. This study tested a model predicting that the risk conveyed by reward sensitivity is mediated by a learning bias for the reinforcing outcomes of alcohol consumption (i.e., positive alcohol expectancy). The model also proposed that the risk conveyed by rash impulsiveness (RI) is mediated by drinkers’ perceived ability to resist alcohol (i.e., drinking refusal self-efficacy).
Methods: Study 1 tested the model in a sample of young adults (n = 342). Study 2 tested the model in a sample of treatment-seeking substance abusers (n = 121). All participants completed a battery of personality, cognitive, and alcohol use questionnaires and models were tested using structural equation modeling.
Results: In both studies, the hypothesized model was found to provide a good fit to the data, and a better fit than alternative models. In both young adults and treatment-seeking individuals, positive alcohol expectancy fully mediated the association between reward sensitivity and hazardous alcohol use. For treatment seekers, drinking refusal self-efficacy fully mediated the association between RI and hazardous drinking. However, there was partial mediation in the young adult sample. Furthermore, neither trait was directly associated with the other cognitive mediator.
Conclusions: The hypothesized model was confirmed on a large sample of young adults and replicated on a sample of treatment-seeking substance abusers. Taken together, these findings shed further light on the mechanisms through which an impulsive temperament may convey risk for alcohol misuse.

Overcoming diversity with a multi-envelope HIV vaccine

A central obstacle to the design of a global HIV vaccine is viral diversity. Antigenic differences in envelope proteins result in distinct HIV serotypes, operationally defined such that antibodies raised against envelope from one serotype will not bind envelope molecules from a different serotype. The existence of serotypes has presented a similar challenge to vaccine development against other pathogens. In such cases, antigenic diversity has been addressed by vaccine design: for example, the poliovirus vaccine includes 3 serotypes of poliovirus, and Pneumovax® presents a cocktail of 23 pneumococcal variants to the immune system. It is likely that a successful vaccine for HIV must also comprise a cocktail of antigens. Here, data relevant to the development of cocktail vaccines, designed to harness diverse, envelope-specific B-cell and T-cell responses, are reviewed.