PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India

Background

A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program.

Objective

To study public knowledge and perceptions of clinical research.

Methods

A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India.

Results

Interviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%).

Conclusions

Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues.     

Computer modeling of nonlinear heart rate dynamics during train extracardial impulsation in the sinoatrial node

A computer model of excitation conduction in the heart has been employed to study the nonlinear heart rate dynamics under stress loads. The modeling was aimed to test the hypothesis explaining changes in the heart rate dynamics during nociceptive stress loads by the occurrence of train extracardial impulsation arriving at the sinoatrial node. The computer simulation shows that, with a particular set of parameters, the model imitates the dynamics of RR intervals observed in experiments. The present model provides a unified theoretical basis for further simulation of various types of ventricular disturbances under external extreme loads.     

Some evolutionary features of bryozoans of the genus <Emphasis Type="Italic">Neotrematopora</Emphasis> Morozova and new <Emphasis Type="Italic">Neotrematopora</Emphasis> species from the Devonian of the Salair Ridge and Rudnyi Altai (Russia)

The evolution of the Neotrematopora species is shown to trend in the direction of developing stronger colonies, implemented in different ways: through changes in the diameter of apertures and thickness of walls of autozooecia, changes in the location and number of diaphragms, number of acanthozooecia and mesozooecia, and the degree to which the latter are filled. An increased development of some structural elements of the colony was compensated for by a decrease in the role of others. Based on the general direction of evolution in the genus Neotrematopora and the succession of its species changing each other in time, several phylogenetic lines in the development of the Early Devonian-Early Givetian Neotrematopora species in the Altai-Sayan folded region are outlined. During the Middle Emsian transgression the species of the Salair paleobasin invaded Gornyi Altai, and those of the Gornyi Altai invaded the Salair. New species from the Emsian (N. spinula sp. nov.) and Eifelian (N. alveolata sp. nov., N. ariadnae sp. nov.) stages of the Salair Ridge and from the Emsian Stage (N. rudnoaltaica sp. nov.) of Rudnyi Altai are described.     

HERITABILITY OF AEROBIC POWER OF INDIVIDUALS IN NORTHEAST BRAZIL

The objective of this study was to evaluate the genetic and environmental contribution to variation in aerobic power in monozygotic (MZ) and dizygotic (DZ) twins. The sample consisted of 20 MZ individuals (12 females and 8 males) and 16 DZ individuals (12 females and 4 males), aged from 8 to 26 years, residents in Natal, Rio Grande do Norte. The twins were assessed by a multistage fitness test. The rate of heritability found for aerobic power was 77%. Based on the results, the estimated heritability was largely responsible for the differences in aerobic power. This implies that such measures are under strong genetic influence.     

Physiologically adequate experimental model of aggression and emotional stress

A simple adequate experimental model of aggression and emotional stress has been elaborated, based on mild fixation of rats tails in the cage wall. It is shown that in a group of rats, in these conditions a continuous aggressive behaviour arises, leading to the development of emotional stress. The elaborated experimental model has no defects, characteristic of other models of aggression and stress. It demands neither a prolonged training of animals nor special expensive equipment; it allows simultaneous use in experiments of a great number of animals, creates conditions for natural aggressive-defensive behaviour of rats without provoking artificial manipulations. The proposed model allows to study the pathogenesis of emotional stress, mechanisms of resistivity and predisposition to it and also search and testing of biologically active substances, enhancing resistance to emotional stress.     

A comparative analysis of the persistence of capillary blood flow oscillations in the left and right rat kidneys

Several parameters of the nonlinear dynamics of blood flow oscillations were studied in the left and right rat kidneys in baseline conditions and a perturbed state. An intramuscular injection of aspirin in 0.9% saline (0.5 mg per 100 g body weight) was used as a perturbation factor. Capillary blood flow was measured at baseline and 50 min after the aspirin injection by laser Doppler flowmetry. The persistence of time series was estimated by the Hurst method. Baseline time series were persistent in the right kidney and nonpersistent in the left kidney. Aspirin-perturbed time series were persistent in both the right and left kidneys, but the Hurst index was significantly higher in the left kidney. The results showed that the microcirculatory bed of the right rat kidney is more stable to perturbation as compared with that of the left kidney.     

Effect of emotional stress on the cardiac rhythm variability in rats

A degree of irregularities of the heart rhythm was studied by two methods: chaos-analysis and the HRV (heart rate variability) analysis. Our study shows an individual response in 3 groups of animals: 1--animals with low initial level of chaos (correlation dimension (PD2 < 2); 2--animals with high level of chaos (PD2 > 4); and animals with middle level of chaos (2 < PD2 < 4). The first two groups proved to be more sensitive to stress than the third group. Moreover we found that the electrical stability of the heart as measured by the fibrillation threshold, was higher for the chaos third group. The animals of the first two groups had low cardiac stability and high risk of stress-induced cardiac disturbances.     

Inhibition of heart formation by lithium is an indirect result of the disruption of tissue organization within the embryo

Lithium is a commonly used drug for the treatment of bipolar disorder. At high doses, lithium becomes teratogenic, which is a property that has allowed this agent to serve as a useful tool for dissecting molecular pathways that regulate embryogenesis. This study was designed to examine the impact of lithium on heart formation in the developing frog for insights into the molecular regulation of cardiac specification. Embryos were exposed to lithium at the beginning of gastrulation, which produced severe malformations of the anterior end of the embryo. Although previous reports characterized this deformity as a posteriorized phenotype, histological analysis revealed that the defects were more comprehensive, with disfigurement and disorganization of all interior tissues along the anterior-posterior axis. Emerging tissues were poorly segregated and cavity formation was decreased within the embryo. Lithium exposure also completely ablated formation of the heart and prevented myocardial cell differentiation. Despite the complete absence of cardiac tissue in lithium treated embryos, exposure to lithium did not prevent myocardial differentiation of precardiac dorsal marginal zone explants. Moreover, precardiac tissue freed from the embryo subsequent to lithium treatment at gastrulation gave rise to cardiac tissue, as demonstrated by upregulation of cardiac gene expression, display of sarcomeric proteins, and formation of a contractile phenotype. Together these data indicate that lithium's effect on the developing heart was not due to direct regulation of cardiac differentiation, but an indirect consequence of disrupted tissue organization within the embryo.     

Nailfold videocapillaroscopy micro-haemorrhage and giant capillary counting as an accurate approach for a steady state definition of disease activity in systemic sclerosis

Introduction

Nailfold videocapillaroscopy (NVC) in systemic sclerosis (SSc) is a procedure commonly used for patient classification and subsetting, but not to define disease activity (DA). This study aimed to evaluate whether the number of micro-haemorrhages (MHE), micro-thrombosis (MT), giant capillaries (GC), and normal/dilated capillaries (Cs) in NVC could predict DA in SSc.

Methods

Eight-finger NVC was performed in 107 patients with SSc, and the total number of MHE/MT, GC, and the mean number of Cs were counted and defined as number of micro-haemorrhages (NEMO), GC and Cs scores, respectively. The European Scleroderma Study Group (ESSG) index constituted the gold standard for DA assessment, and scores ≥3.5 and =3 were considered indicative of high and moderate activity, respectively.

Results

NEMO and GC scores were positively correlated with ESSG index (R = 0.65, P <0.0001, and R = 0.47, P <0.0001, respectively), whilst Cs score showed a negative correlation with that DA index (R = −0.30, P <0.001). The area under the curve (AUC) of receiver operating characteristic plots, obtained by NEMO score sensitivity and specificity values in classifying patients with ESSG index ≥3.5, was significantly higher than the corresponding AUC derived from either GC or Cs scores (P <0.03 and P <0.0006, respectively). A modified score, defined by the presence of a given number of MHE/MT and GC, had a good performance in classifying active patients (ESSG index ≥3, sensitivity 95.1%, specificity 84.8%, accuracy 88.7%).

Conclusions

MHE/MT and GC appear to be good indicators of DA in SSc, and enhances the role of NVC as an easy technique to identify active patients.