Dental Implants – Perceiving Patients’ Satisfaction in Relation to Clinical and Electromyography Study on Implant Patients

The aim of this study is to evaluate the satisfaction of patients with posterior implants in relation to the clinical success criteria and surface electromyography (sEMG) findings of the masseter and temporalis muscles. Total 42 subjects were investigated. Twenty one subjects with posterior dental implants were interviewed using a questionnaire and the clinical success criteria were determined based on The International Congress of Oral Implantologists. The myofunction of the masticatory muscles were assessed using sEMG (21 subjects) and compared to the control group of subjects without implants (21 subjects). Out of 21 subjects, all were satisfied with the aesthetics of their implant. Twenty of them (95.2%) were satisfied with its function and stability. As for clinical criteria, 100% (50) of the implants were successful with no pain, mobility or exudates. sEMG findings showed that patients have significantly lower (p<0.01) basal or resting median power frequency but with muscle burst. During chewing, control subjects showed faster chewing action. There was no difference in reaction and recovery time of clenching for both groups. In conclusion, the satisfaction of implant patients was high, and which was in relation to the successful clinical success criteria and sEMG findings.     

BENEFITS TO RESEARCH SUBJECTS IN INTERNATIONAL TRIALS: DO THEY REDUCE EXPLOITATION OR INCREASE UNDUE INDUCEMENT?

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally‐sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. It proceeds from the premise that there are good grounds for thinking that, at least some, international research sponsors exploit trial participants because they do not provide the research population with a fair share of the benefits of research. This provides a prima facie argument for increasing the benefits for research participants. Concern over undue inducement is a legitimate moral concern; however, if this concern is to prevent research populations from receiving their fair share of benefits from research there must be sufficient evidence that these benefits will unduly influence patients’ decision‐making regarding trial participation. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants’ motivations and the influence of payments on research subjects’ behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects’ behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants.     

Sway-dependent modulation of the triceps surae H-reflex during standing.

Previous research has shown that changes in spinal excitability occur during the postural sway of quiet standing. In the present study, it was of interest to examine the independent effects of sway position and sway direction on the efficacy of the triceps surae Ia pathway, as reflected by the Hoffman (H)-reflex amplitude, during standing. Eighteen participants, tested under two different experimental protocols, stood quietly on a force platform. Percutaneous electrical stimulation was applied to the posterior tibial nerve when the position and direction of anteroposterior (A-P) center of pressure (COP) signal satisfied the criteria for the various experimental conditions. It was found that, regardless of sway position, a larger amplitude of the triceps surae H-reflex (difference of 9-14%; P = 0.005) occurred when subjects were swaying in the forward compared with the backward direction. The effects of sway position, independent of the sway direction, on spinal excitability exhibited a trend (P = 0.075), with an 8.9 +/- 3.7% increase in the H-reflex amplitude occurring when subjects were in a more forward position. The observed changes to the efficacy of the Ia pathway cannot be attributed to changes in stimulus intensity, as indicated by a constant M-wave amplitude, or to the small changes in the level of background electromyographic activity. One explanation for the changes in reflex excitability with respect to the postural sway of standing is that the neural modulation may be related to the small lengthening and shortening contractions occurring in the muscles of the triceps surae.     

Insights on the robust variance estimator under recurrent-events model

Recurrent events are common in medical research for subjects who are followed for the duration of a study. For example, cardiovascular patients with an implantable cardioverter defibrillator (ICD) experience recurrent arrhythmic events that are terminated by shocks or antitachycardia pacing delivered by the device. In a published randomized clinical trial, a recurrent-event model was used to study the effect of a drug therapy in subjects with ICDs, who were experiencing recurrent symptomatic arrhythmic events. Under this model, one expects the robust variance for the estimated treatment effect to diminish when the duration of the trial is extended, due to the additional events observed. However, as shown in this article, that is not always the case. We investigate this phenomenon using large datasets from this arrhythmia trial and from a diabetes study, with some analytical results, as well as through simulations. Some insights are also provided on existing sample size formulae using our results.     

Asymmetries in stimulus comparisons by monkey and man

Similarity is a core concept in theories of object recognition, categorization, and reasoning. It is often conceptualized as a geometric distance in a multidimensional stimulus space. However, research in humans has revealed that similarity judgments involve more than a simple distance calculation and tend to be asymmetric when stimuli differ in factors such as prototypicality. For example, most people judge 99 to be more similar to 100 than 100 to 99. Up to now, it was not known whether such asymmetries might also occur in nonhuman subjects. This study reveals asymmetries in the pattern of errors made by four rhesus monkeys in a temporal same/different task. Monkeys usually perceived a smaller difference between two different stimuli when the first stimulus in a trial was less prototypical than the second, just as what was found previously for human subjects. The pattern of asymmetries differed between monkeys, and a control study showed that such variability is also present for human subjects. We propose that known neurophysiological mechanisms can account for asymmetry in the stimulus comparisons of both species. Thus, seemingly complex phenomena that occur when human subjects rate stimulus similarity are also present in macaques' similarity judgments and could be based on relatively simple mechanisms.     

Research, Informed Consent, and the Limits of Disclosure

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers' personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects' autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers' job and (ii) that subjects should be told of researchers' views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.     

Effect of ageing and vision on limb load asymmetry during quiet stance

Although the identification and characterization of limb load asymmetries during quiet standing has not received much research attention, they may greatly extend our understanding of the upright stance stability control. It seems that the limb load asymmetry factor may serve as a veridical measure of postural stability and thus it can be used for early diagnostic of the age-related decline in balance control. The effects of ageing and of vision on limb load asymmetry (LLA) during quiet stance were studied in 43 healthy subjects (22 elderly, mean age 72.3+/-4.0 yr, and 21 young, mean age 23.9+/-4.8 yr). Postural sway and body weight distribution were recorded while the subject was standing on two adjacent force platforms during two 120 s trials: one trial was performed with the eyes open (EO), while the other trial was with the eyes closed (EC). The results indicate that LLA was greater in the old adults when compared with the young control subjects. The LLA values were correlated with the postural sway magnitudes especially in the anteroposterior direction. Eyes closure which destabilized posture resulted in a significant increase of body weight distribution asymmetry in the elderly but not in the young persons. The limb load difference between EO and EC conditions showed a significantly greater effect of vision on LLA in the elderly compared to the young subjects. The observed differences in the LLA may be attributed to the decline of postural stability control in the elderly. Ageing results in the progressive decline of postural control and usually the nervous system requires more time to complete a balance recovery action. To compensate for such a deficiency, different compensatory strategies are developed. One of them, as evidenced in our study, is preparatory limb unload strategy (a stance asymmetry strategy) which could significantly shorten reaction time in balance recovery.     

Informed Consent, Exploitation and Whether it is Possible to Conduct Human Subjects Research Without Either One

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devastating conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions.     

Cerebrospinal fluid markers in differential diagnosis of Alzheimer's disease and vascular dementia

Alzheimer's disease (AD) and vascular dementia (VaD) are the two most common causes of dementia in old people. They remain difficult to differentiate in practice because of lack of sensitivity and specificity of current clinical diagnostic criteria. Recent molecular and cellular advancements indicate that the use of cerebrospinal fluid markers may improve early detection and differential diagnosis of AD. Our objective in this study was to determine diagnostic accuracy of three cerebrospinal (CSF) markers: total tau protein (t-tau), tau protein phosphorylated on threonine 181 (p-tau181) and tau protein phosphorylated on serine 199 (p-tau199). Using commercially available ELISA kits concentrations of t-tau, p-tau181 and p-tau199 were analyzed in 12 patients with probable AD, 9 patients with VaD and 12 NC subjects. The median levels of all three markers were significantly higher in AD group versus VaD and NC groups. However, when the sensitivity levels were set to 85% or higher, only t-tau and p-tau199 satisfied consensus recommendations (specificity more than 75%) when differentiating AD from VaD. In conclusion, our preliminary data on a small group of selected subjects suggest that the CSF t-tau and p-tau199 levels are useful markers for differentiating AD from VaD.     

Ethical Issues in Field Trials of Genetically Modified Disease‐Resistant Mosquitoes

Mosquito‐borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito‐borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease‐resistant, genetically modified mosquitoes. Some of these issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un‐enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito‐borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case‐by‐case basis.     

Evidence for Inhibitory Allelopathic Interactions Involving Phenolic Acids in Field Soils: Concepts vs. an Experimental Model

The accepted criteria for identifying allelopathic interactions in the field that have been proposed in the literature offer heuristic function, but to date have failed as a framework for research and diagnostics. If the present criteria are to be modified to make them useful empirically, their shortcomings must be identified. For this review, data from the literature and from defined model systems consisting of plants, soil, and/or microbes are used to evaluate the applicability of the accepted criteria to defined systems in which plants are responding to known allelochemicals. Based on this evaluation, modified criteria are proposed. In many respects, however, the modified criteria are as difficult to satisfy in the field as those proposed previously. The new criteria have value as a research framework because they clearly suggest that a shift in research focus to the soil environment, specifically the barrier of the rhizosphere through which allelochemicals must pass, is essential if the role of allelopathic interactions in the field is to be established.     

Withholding cardiopulmonary resuscitation: proposals for formal guidelines.

Working with members of the Royal London Trust and its medical council, Len Doyal and Daniel Wilsher have composed a set of guidelines governing the making of decisions to withhold resuscitation from patients. The guidelines describe the procedures that should be followed when giving orders for non-resuscitation and the clinical, legal, and moral criteria that should be satisfied before such orders are issued. The authors hope that these guidelines will be of help to those responsible for the creation of hospitals'' policies for non-resuscitation.     

WHICH BENEFITS OF RESEARCH PARTICIPATION COUNT AS ‘DIRECT’?

It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research.     

GOING FROM PRINCIPLES TO RULES IN RESEARCH ETHICS

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis‐à‐vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in the validity of the rules. I conclude by arguing that this is not likely to be accomplished. The rules I call into question are the rules requiring:

• – that studies be designed in a scientifically valid way
• – that risks to subjects be minimized
• – that subjects be afforded post‐trial access to experimental interventions
• – that inducements paid to subjects not be counted as a benefit to them
• – that inducements paid to subjects not be ‘undue’
• – that subjects must remain free to withdraw from the study at any time for any reason without penalty

Both canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries.     

The rational design of biological complexity: a deceptive metaphor

Biologists often claim that they follow a rational design strategy when their research is based on molecular knowledge of biological systems. This claim implies that their knowledge of the innumerable causal connections present in biological systems is sufficient to allow them to deduce and predict the outcome of their experimental interventions. The design metaphor is shown to originate in human intentionality and in the anthropomorphic fallacy of interpreting objects, events, and the behavior of all living organisms in terms of goals and purposes. Instead of presenting rational design as an effective research strategy, it would be preferable to acknowledge that advances in biomedicine are nearly always derived from empirical observations based on trial and error experimentation. The claim that rational design is an effective research strategy was tested in the case of current attempts to develop synthetic vaccines, in particular against human immunodeficiency virus. It was concluded that in this field of biomedicine, trial and error experimentation is more likely to succeed than a rational design approach. Current developments in systems biology may give us eventually a better understanding of the immune system and this may enable us in the future to develop improved vaccines.     

Health Education through Analogies: Preparation of a Community for Clinical Trials of a Vaccine against Hookworm in an Endemic Area of Brazil

Background

Obtaining informed consent for clinical trials is especially challenging when working in rural, resource-limited areas, where there are often high levels of illiteracy and lack of experience with clinical research. Such an area, a remote field site in the northeastern part of the state of Minas Gerais, Brazil, is currently being prepared for clinical trials of experimental hookworm vaccines. This study was conducted to assess whether special educational tools can be developed to increase the knowledge and comprehension of potential clinical trial participants and thereby enable them to make truly informed decisions to participate in such research.

Methodology/Principal Findings

An informational video was produced to explain the work of the research team and the first planned hookworm vaccine trial, using a pedagogical method based on analogies. Seventy-two adults living in a rural community of Minas Gerais were administered a structured questionnaire that assessed their knowledge of hookworm, of research and of the planned hookworm vaccine trial, as well as their attitudes and perceptions about the researchers and participation in future vaccine trials. The questionnaire was administered before being shown the educational video and two months after and the results compared. After viewing the video, significant improvements in knowledge related to hookworm infection and its health impact were observed: using a composite score combining related questions for which correct answers were assigned a value of 1 and incorrect answers a value of 0, participants had a mean score of 0.76 post-video compared to 0.68 pre-video (p = 0.0001). Similar improvements were seen in understanding the purpose of vaccination and the possible adverse effects of an experimental vaccine. Although 100% of participants expressed a positive opinion of the researchers even before viewing the film and over 90% said that they would participate in a hookworm vaccine trial, an increase in the number who expressed fear of being vaccinated with a novel vaccine was seen after viewing the video (51.4% post-video versus 29.2% pre-video). Increases were also seen in the proportion who thought that participation in a vaccine trial would be inconvenient or disrupt their daily activities.

Conclusions/Significance

Even in rural, resource-limited populations, educational tools can be specially designed that significantly improve understanding and therefore the likelihood of obtaining truly informed consent for participation in clinical research. The observed changes in the knowledge and perceptions of the research participants about hookworm infection and the experimental hookworm vaccine demonstrate that the video intervention was successful in increasing understanding and that the subjects acquired knowledge pertinent to the planned research.     

Reliability of the reactive strength index and time to stabilization during depth jumps

The reliability of the reactive strength index (RSI) and time to stabilization (TTS) during maximal-effort plyometric depth jumps was examined. Twenty-two subjects performed three depth jumps from a height of 30 cm. Measures such as height of jump (JH), ground-contact time (CT), RSI, and TTS were obtained and analyzed for reliability using Cronbach alpha reliability coefficient and intraclass correlations. The JH, CT, and RSI were shown to be highly reliable from trial to trial (evidenced by high Cronbach reliability coefficients (alpha > 0.95) and high single- and average-measures intraclass correlations (>0.9). Time to stabilization was not reliable from trial to trial, as evidenced by a low Cronbach reliability coefficient (alpha < 0.7) and poor single- (<0.5) and average-measures (<0.7) intraclass correlations. The RSI was observed to be consistent for single measures, suggesting that coaches dealing with large numbers of athletes can conduct only a single trial from each depth jump height when attempting to optimize plyometric depth jump heights for their athletes. Time to stabilization could be a useful tool for strength and conditioning investigators to quantify the landing portion of plyometric exercises, but the protocol used in the current study to measure this variable did not prove to be reliable. Investigators wishing to use this measurement in such a context in future research studies may need to allow subjects appropriate habituation periods and control for arm movement during the landing phase of the exercise.     

EXPLOITATION IN PAYMENTS TO RESEARCH SUBJECTS

Offering cash payments to research subjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower limit meets resistance in two places: (1) denial that the payments offered by researchers are wages for participation; and (2) concern about undue inducement. This paper critically examines these arguments for and against a lower limit. It shows that the need for a lower limit cannot be avoided by adopting a non‐wage payment model and that concerns about undue inducement are unjustified in all trials except those that present greater than minimal risk. This analysis suggests the following compromise position: there should be an unconditional lower limit on payment amounts so that researchers cannot offer less than a fair wage, and when researchers cannot satisfy this limit because fairness requires a problematically large payment, then researchers should offer no payment at all.     

Preparing chimpanzees for laboratory research

The chimpanzee is the only representative of the Great Apes that is extensively involved in biomedical research in primate laboratories. These apes are used as animal models in a variety of studies, including research on infectious disease, parasitic disease, pharmacokinetic studies, neuroscience, cognition, and behavior. Chimpanzees used in biomedical research in the United States reside largely in six specialized research and holding facilities, and most of the research with them is conducted at these sites. Given the relatively small population of chimpanzees and its importance to biomedical research, it is imperative that we carefully manage the care, production, and use of these animals in biomedical research studies. Selection criteria and preparation techniques are reviewed in this article in an effort to begin a discussion on best practices for choosing and handling chimpanzees participating in biomedical research. The use of routine health assessment information is described for subject selection, as are behavioral issues to be considered. Due to the relatively small number of chimpanzees available, issues related to experimental design and multiple uses of chimpanzees are discussed. Practices related to the transportation and acclimation of chimpanzees are described. Finally, behavioral conditioning procedures are discussed, including habituation, desensitization, and positive reinforcement training that have been applied to reduce animal distress and improve the quality of the science being conducted with chimpanzee subjects.     

Stability and viability of Neisseria gonorrhoeae in various solutions and buffers.

The stability and viability of Neisseria gonorrhoeae WP (T4) was tested in a variety of buffers and solutions, many of which are commonly used in gonococcal research. Each solution was tested at room temperature for its ability to maintain stability and viability of gonococci in concentrated suspensions and to maintain viability of gonococci in dilute suspensions. The 14 buffers and solutions tested could be divided into four groups based upon these criteria. Only a few solutions satisfied all three criteria. Of those tested, Gey salt solution and bovine serum albumin (0.01%) and proteose peptone (1%) in saline were the only two in which the gonococci retained viability in dilute suspensions for 25 min. Most of the solutions were not able to maintain viability of gonococci in dilute suspensions, even when the same solution was capable of maintaining stability and viability in concentrated suspensions.