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PubMed2005

The development of acute respiratory distress syndrome after gut ischemia/reperfusion injury followed by fecal peritonitis in pigs: a clinically relevant model.

Numerous clinical trials using anti-inflammatory agents for patients with acute respiratory distress syndrome (ARDS) have failed despite efficacy in acute animal models. This underscores the necessity of developing a clinically relevant model of ARDS. Initially, we attempted to induce lung injury in pigs by fecal peritonitis only. When this was unsuccessful, we designed a two-hit model of ischemia/reperfusion (I/R) injury followed by fecal peritonitis to create a clinically applicable model of ARDS. The initial study consisted of Yorkshire swine [group 1, fecal clot (FC), n = 4] that were followed clinically after intraperitoneal placement of a fecal (0.5 mL/kg) blood (2 mL/kg) clot. Blood was sampled daily for cultures, a complete blood count, a lactate level, and various cytokine expression determined by enzyme-linked immunosorbent assay (ELISA). Pigs were treated with antibiotics and fluids, placed on a ventilator before sacrifice to obtain hemodynamic and pulmonary parameters, and underwent histologic lung assessment. Additionally, bronchoalveolar lavage fluid was obtained for protein concentration and cytokine levels. Once it was evident that no lung injury had occurred, we designed a more severe model. A second group of Yorkshire swine [group 2, superior mesenteric artery (SMA) + FC, n = 4] underwent SMA occlusion for 30 min (I/R) followed by intraperitoneal placement of a FC as in the initial group. These pigs were monitored more invasively and continuously in an intensive care setting for 48 h and followed, treated, and assessed in a similar fashion to group 1. Group 1 (FC) pigs survived 9 days and showed signs of sepsis (bacteremia with polymicrobial organisms), an inflammatory response in the form of elevated cytokines, yet no physiologic or histologic evidence of lung injury. Group 2 (SMA + FC) pigs demonstrated more severe sepsis, a significantly increased cytokine response compared with animals in the FC group, and physiologic signs of progressive pulmonary injury. Pigs in the SMA + FC group were sacrificed at 48 h after clinical deterioration (significant decline in oxygenation) and demonstrated pathologic evidence of lung injury indicated by increased bronchoalveolar lavage fluid protein, diffuse and thickened alveolar septae, hyaline membrane formation, and pulmonary edema. The addition of a second "hit" (SMA occlusion, I/R) to a FC sepsis model resulted in severe lung injury that developed within a 3-day period. To our knowledge, this is the first large animal experiment that definitively and consistently causes insidious onset ARDS in pigs. By closely paralleling the clinical development of pulmonary injury, this model should prove invaluable in the study of human ARDS.

Animals↗
PubMedDate not supplied

Effect of reference point on visual evoked potentials: clinical relevance.

For clinical purposes the VEP is generally recorded from the mid-occipital region referenced to the vertex or mid-frontal region. This may lead to interpretive errors that can be avoided if a relatively inactive reference point, such as linked mastoids, is used simultaneously. The additional recording derivation may also be helpful in clarifying aberrant or ambiguous wave forms. The diagnostic yield from the two montages is similar, although the linked-mastoid reference provides a greater number of technically inadequate recordings due to smaller size of P100 and increased contamination by muscle artifact.

Adolescent↗
PubMed1995

Ischaemic preconditioning: is it clinically relevant?

Direct clinical evidence for the classical preconditioning phenomenon, with infarct size limitation as an endpoint, cannot be obtained. However, a number of patient groups have been identified in which adaptation to ischaemia has been demonstrated by enhanced recovery of function or preservation of high energy phosphates in models of repeated ischaemia, such as atrial pacing stress tests, percutaneous transluminal coronary angioplasty and aortic cross-clamping during cardiac surgery. Evidence is accumulating that mechanisms which are operative in experimental ischaemic preconditioning (infarct size limitation) are also operative in these clinical models of repeated reversible ischaemia. Insight into the mechanisms responsible for ischaemic preconditioning could potentially help to develop pharmacological agents which mimic preconditioning. This is especially attractive as several of the ischaemic episodes maybe too short or insufficiently severe to trigger preconditioning. By a synergistic or additive action, the combination of such a stimulus with a low dose of pharmacological agent might result in protective action. If these agents were also to be used for treating cardiovascular conditions, such as the K+ATP channel activator nicorandil for the treatment of angina pectoris, the cardioprotective effect could be a beneficial side effect. The currently available protein kinase C activators are oncogenic, but with the recognition and better understanding of the different subtypes possibly involved in preconditioning, new protein kinase C activators may become available without these side-effects. On the other hand, hearts of patients who regularly experience episodes of ischaemia may be in a more or less permanent state of preconditioning afforded by one of these stimuli or have developed tolerance. In this situation it is likely that (additional) protection by a pharmacological agent cannot be accomplished at that time. It is reassuring, however, that in the animal, preconditioning can be reinstated immediately after the cardioprotection is lost and that it can also be demonstrated in hearts with pathological conditions such as hypertrophy. Finally, in view of the observations that cardioprotection may also be produced by transient ischaemia in other organs, and even by some forms of stress which do not lead to myocardial ischaemia, it could be envisioned that ischaemic preconditioning is only one component of a general form of adaptation.

Aged↗
PubMed1997

Uterine pinopodes in peri-implantation human endometrium. Clinical relevance.

Current clinical studies indicate the existence in the human of an "implantation/nidation window," similar to that observed in animal models. During this short period of uterine receptivity, the formation of pinopodes on the apical cell membrane of the endometrial epithelium is a consistent morphological event, observed in a number of species studies including the human. In order to develop a specific marker of the implantation window in clinical practice, we have investigated the kinetics of pinopode formation through sequential endometrial sampling under various hormonal conditions. Our results show that the implantation window in humans, according to this marker, lasts less than 48 hours, and the timing of its opening is dependent on the hormonal treatment applied, occurring earlier in cycles following ovarian stimulation and later in cycles induced by hormone replacement treatment. Furthermore, the timing varies among different individuals under the same treatment. These findings suggest that examination for pinopodes in endometrial samples can be highly useful in infertility treatment and research for the assessment of the nidation window on an individual basis. Our preliminary data strongly support the value of this assessment for better timing of ovum transfer, leading to an increase in implantation rates. Studies are now in progress on the expression of other endometrial signals present in relation to the pinopodes.

Embryo Implantation↗
PubMed2004

The human lateral pterygoid muscle: a review of some experimental aspects and possible clinical relevance.

The clinical notion that some disturbance to the activity of the lateral pterygoid muscle plays a role in the aetiology of temporomandibular disorders (TMD) is still widely accepted and influences management strategies. However, there is no rigorous scientific evidence to support this clinical notion and the role of the lateral pterygoid muscle in normal function is still controversial. The classically defined functions of each head of the muscle are that the superior head is active on closing, retrusion, and ipsilateral jaw movements, while the inferior head is active on opening, protrusion and contralateral jaw movements. However, recent data indicate that these concepts are too simplistic. For example, recent evidence suggests that parts of the superior head may also be active on opening, protrusion and contralateral jaw movements, and that the superior head may consist of three mediolaterally arranged functional zones. Given these complexities, the proposal that clicking and/or locking conditions arise in the temporomandibular joint through some form of lack of co-ordination between the two heads of the muscle needs re-evaluation. Despite earlier reports to the contrary, both heads of the lateral pterygoid muscle appear to be electrically silent at the postural or resting jaw position, and therefore appear to play no role in the anteroposterior positioning of the jaw at the postural position. An important role has also been demonstrated electromyographically for progressive changes in activity in the inferior head as the direction of horizontal jaw force shifts from one side to the other. This suggests an important role for the lateral pterygoid muscle in the generation of side-to-side and protrusive jaw forces. The lateral pterygoid muscle is likely therefore to play an important role in parafunctional excursive jaw movements and also possibly a role in influencing jaw position in patients where the maxillomandibular relationship records change from session to session. The above data provide new insights into the normal function of the lateral pterygoid muscle. The proposal that the lateral pterygoid muscle plays some role in the aetiology of TMD needs now to be rigorously tested.

Bite Force↗
PubMed1993

Mesangial IgG in childhood minimal change disease: clinical relevance.

The clinical courses of five children with the nephrotic syndrome and renal biopsies diagnosed as minimal change disease (MCD) by light microscopy but with mesangial immune deposits of IgG (> or = 2+) and no dominant or codominant IgA were reviewed retrospectively to determine if the presence of significant mesangial deposits of IgG has prognostic implications and to evaluate the treatment these patients received. All five of the children were steroid dependent or resistant initially, and four received cyclosporine or cytotoxic agents later. After a mean follow-up period of 2.9 years for four and 20 years for one, all are in remission. All have normal renal function with no hypertension. These results suggest that the deposition of IgG in the mesangium of biopsies from patients with MCD by light microscopy may predict a more difficult course initially and may require more aggressive treatment to achieve permanent remission.

Biopsy↗
PubMed1989

The clinical relevance of sex selection techniques.

Clinical and laboratory attempts to alter the sex ratio require more complete and thorough study. Improved identification of Y-bearing sperm through chromosome evaluation rather than by F-body identification is critical to provide a more precise definition. The tentative conclusions stated below are based on an assessment of literature from which it is generally difficult to draw conclusions: 1. The timing of intercourse in relation to ovulation and subsequent fertilization appears to influence the sex ratio. More females are conceived when coitus occurs relatively close to ovulation, and more males are conceived when the sperm or egg is in the reproductive tract for a relatively longer time before conception. The influence of coital timing on the sex ratio is overall quite subtle and is not a practical method to alter the sex ratio for individual couples. 2. The use of ovulation-inducing medications slightly favors female offspring. A decrease in sex ratio of 5% to 10% has been shown in multiple studies. 3. Artificial insemination with fresh donor or homologous spermatozoa results in more male births with a reported 7% to 10% increase in the sex ratio. It appears that ovulation induction combined with artificial insemination cancels the respective influences of each on the sex ratio. 4. Sperm separation techniques using albumin (for selection of Y-bearing sperm) or Sephadex column filtration (for selection of X-bearing sperm) are the only techniques that have been reported to alter the sex ratio to a degree that is clinically relevant. Although clinical birth data are just beginning to accumulate, these methods appear to have a 70% to 80% success for selection of assumed Y-bearing sperm and a 75% to 80% success for selection of assumed X-bearing sperm. The validity of these results will remain questionable until fully detailed accounts are published and successfully repeated. Free-flow electrophoresis appears to achieve significant separation; however, the depressed postprocedure spermatozoa motility presently limits the usefulness of this procedure. 5. There is a potential to combine clinical and laboratory methods to maximize the efficiency of sex selection for interested couples. Modern methods to identify ovulation (e.g., urinary LH kits, ultrasonography) may help the timing of coitus for sex selection. Clomiphene citrate may enhance female sex preselection when Sephadex column filtration is also employed. 6. The priority of sex preselection in terms of medical, social, and demographic consideration remains to be determined. The avoidance of sex-linked genetic disorders is a reasonable and desirable goal.(ABSTRACT TRUNCATED AT 400 WORDS)

Cell Separation↗
PubMed2004

Publications in anesthesia journals: quality and clinical relevance.

Clinicians performing evidence-based anesthesia rely on anesthesia journals for clinically relevant information. The objective of this study was to analyze the proportion of clinically relevant articles in five high impact anesthesia journals. We evaluated all articles published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anesthesia, Anesthesia, and Acta Anaesthesiologica Scandinavica from January to June, 2000. Articles were assessed and classified according to type, outcome, and design; 1379 articles consisting of 5468 pages were evaluated and categorized. The most common types of article were animal and laboratory research (31.2%) and randomized clinical trial (20.4%). A clinically relevant article was defined as an article that used a statistically valid method and had a clinically relevant end-point. Altogether 18.6% of the pages had as their subject matter clinically relevant trials. We compared the Journal Impact Factor (a measure of the number of citations per article in a journal) and the proportion of clinically relevant pages and found that they were inversely proportional to each other.

Anesthesiology↗
PubMed1996

Meaning in life: clinical relevance and predictive power.

The clinical relevance of the meaning in life construct is examined by evaluating its ability to predict patients' general and psychological well-being and their post-treatment functioning. Evidence is obtained for the notion that meaning in life (a) would affect both positive and negative aspects of well-being, (b) that it would be related to improvement during psychotherapy, and (c) that it would predict the outcome of psychotherapy, independently of patients' pre-treatment levels of well-being. The findings not only support the clinical relevance of the meaning in life concept, but they also favour the construct validity of the Life Regard Index, an instrument that was designed to measure the relevant construct. It is concluded that the neglected meaning in life issue deserves greater therapeutic and scientific consideration. Clinical implications and suggestions for future research are discussed.

Adaptation, Psychological↗
PubMed2003

The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivity.

Given the fact that infection with high-risk human papillomavirus (HPV) is causally involved in cervical cancer, addition of high-risk HPV testing to a cervical smear may improve the efficacy of cervical cancer screening programmes, the triage of women with equivocal or borderline Pap smears, and the monitoring of women who have been treated for cervical intraepithelial neoplasia grade 3 (CIN 3). Compared to a cervical smear HPV tests revealed a superior sensitivity (ie clinical sensitivity) for lesions >/= CIN 3, and a negative predictive value approaching 100%. However, a potential complication is the availability of several HPV testing methods, all displaying a different sensitivity and specificity to detect HPV-positive women (ie analytical sensitivity and specificity). There is now compelling evidence that the clinical sensitivity and specificity of HPV tests are not simply synonymous to their analytical sensitivity and specificity, respectively. In fact, a distinction between so-called clinically relevant and irrelevant high-risk HPV infections should be made when considering HPV tests for primary screening, triage policies, or post-treatment monitoring. Here, we discuss the potential importance of HPV load in the context of currently widely applied HPV detection methods, to distinguish clinically relevant from irrelevant HPV infections. From this it can be concluded that it is of utmost importance to define criteria, involving viral load threshold and the type of HPV detection method that should be fulfilled by an HPV test before implementation of such a test in clinical practice and population-based cervical cancer screening programmes.

Female↗
PubMed2004

Mobile phone interference with medical equipment and its clinical relevance: a systematic review.

OBJECTIVE: To conduct a systematic review of studies on clinically relevant digital mobile phone electromagnetic interference with medical equipment. DATA SOURCES: MEDLINE and SUMSEARCH were searched for the period 1966-2004. The Cochrane Library and Database of Abstracts of Reviews of Effects were also searched for systematic reviews. STUDY SELECTION: Studies were eligible if published in a peer-reviewed journal in English, and if they included testing of digital mobile phones for clinically relevant interference with medical equipment used to monitor or treat patients, but not implantable medical devices. DATA SYNTHESIS: As there was considerable heterogeneity in medical equipment studied and the conduct of testing, results were summarised rather than subjected to meta-analysis. RESULTS: Clinically relevant electromagnetic interference (EMI) secondary to mobile phones potentially endangering patients occurred in 45 of 479 devices tested at 900 MHz and 14 of 457 devices tested at 1800 MHz. However, in the largest studies, the prevalence of clinically relevant EMI was low. Most clinically relevant EMI occurred when mobile phones were used within 1 m of medical equipment. CONCLUSIONS: Although testing was not standardised between studies and equipment tested was not identical, it is of concern that at least 4% of devices tested in any study were susceptible to clinically relevant EMI. All studies recommend some type of restriction of mobile phone use in hospitals, with use greater than 1 m from equipment and restrictions in clinical areas being the most common.

Australia↗
PubMed2005

User-related pharmaceutical care problems and factors affecting them: the importance of clinical relevance.

BACKGROUND AND OBJECTIVES: Many studies determined the number and nature of user-related Pharmaceutical Care Problems (PCP) and factors affecting them, but none considered the inclusion of clinical relevance. The aims of this study are (i) to investigate the type, number and clinical relevance of user-related PCP self-reported by home dwelling elderly on polypharmacy and (ii) to develop a risk-model for detecting elderly drug-users at risk of user-related PCP. METHODS: The study was a cross-sectional study conducted among 286 home dwelling elderly on polypharmacy (> or =75 years, > or =4 medicines) in the Netherlands. The user-related PCP found were divided into problem categories and subsequently a pharmacist and a general practitioner classified the problems into those with low and those with (potential) clinical relevance. Factors possibly associated with PCP (both for all and relevant problems) were identified, and subsequently tested in multivariate models using logistic regression. RESULTS: Three hundred and ninety-eight user-related PCP were observed in 189 patients (66% of all participants). After classification of user-related PCP only 26% appeared to be of clinical relevance (26% of all participants). When including clinical relevance a shift in predominantly present problem categories is observed. Furthermore, the risk model for problems with clinical relevance contains more factors than the model which considered all problems. Factors associated with clinically relevant PCP are emotional or physical problems interfering with social life, communication skills (vision and hearing), using tablets that have to be divided, using inhaled medicines, and the number of medicines used. This risk-model has a specificity of 92% and a sensitivity of 32%. CONCLUSIONS: Although user-related PCP were seen in about two-thirds of the participants, in only one out of four participants was the PCP considered to be of clinical relevance. With inclusion of clinical relevance, other problem categories become more dominant. A specific risk model is designed to select elderly patients that are most likely to have PCP in need of more urgent intervention. Unfortunately higher specificity is accompanied by low sensitivity in the present model.

Aged↗
PubMed1984

Serial evoked potential studies in patients with definite multiple sclerosis. Clinical relevance.

Twelve patients with clinically definite multiple sclerosis were examined both clinically and electrophysiologically at repeated intervals over one year to determine the clinical relevance of data obtained by serial multimodality evoked potential studies. We frequently found a disparity between the clinical and electrophysiologic changes, and also an excessive variability between test sessions of the responses to stimulation of a clinically involved afferent pathway even when the clinical deficit was stable. Our findings indicate that though evoked potential studies may provide information of diagnostic relevance, their role in monitoring disease progression has not been established.

Adult↗
PubMed1996

Clinical relevance of ambulatory versus clinic blood pressure when evaluating antihypertensive therapy.

REVIEW IN DEPTH: The evaluation of the effect of antihypertensive drugs over time has led to the increasing popularity of noninvasive ambulatory monitoring of blood pressure in the drug development process. Although not mandated by the Food and Drug Administration of the USA, from a practical standpoint new drug applications for antihypertensive agents typically include one or more studies that have used ambulatory blood pressure recordings. Ambulatory blood pressure monitoring is now used in several phases of drug development, including phase II dose-ranging studies, phase III efficacy studies, and phase IV comparative trials. The perceived benefit of the ambulatory blood pressure methodology during drug development is that it avoids observer bias, markedly reduces the effect of placebo, and may economize on sample size, especially in cross-over-designed trials. Furthermore, there is a clinical benefit of ambulatory blood pressure monitoring in the assessment of antihypertensive drugs because it allows evaluation of the effect and duration of effect of a drug during activities of daily living, including sleep.

Journal Article↗
PubMed2001

Clinical relevance of the babA2 genotype of Helicobacter pylori in Japanese clinical isolates.

Genotypic variation of Helicobacter pylori is speculated to associate with different clinical outcomes. In Western countries, the gene encoding blood group antigen-binding adhesin (BabA), babA2, is of high clinical relevance and is a useful marker to identify patients who are at higher risk for peptic ulceration and gastric adenocarcinoma, as are vacA and cagA. We investigated the presence of babA2 and cagA in 179 Japanese clinical isolates by PCR and Southern blot analysis and looked for correlations with various clinical outcomes (nonulcer dyspepsia, duodenal ulcers, gastric ulcers gastric adenocarcinoma, and mucosa-associated lymphoid tissue lymphoma). The prevalence of the babA2 genotype was 84.9% and that of the cagA genotype was 96.1%. There was no correlation between the babA2 and cagA genotypes, and there was no association between the babA2 or cagA status and clinical outcome. These results indicate that babA2 status is not of high clinical relevance in Japan and that Japanese strains are different from those infecting Western populations.

Adhesins, Bacterial↗
PubMed2004

Assessing the validity of the USMLE step 2 clinical knowledge examination through an evaluation of its clinical relevance.

PURPOSE: To assess the validity of the USMLE Step 2 Clinical Knowledge (CK) examination by addressing the degree to which experts view item content as clinically relevant and appropriate for Step 2 CK. METHOD: Twenty-seven experts were asked to complete three survey questions related to the clinical relevance and appropriateness of 150 Step 2 CK multiple-choice questions. Percentages, reliability estimates, and correlation coefficients were calculated and ordinary least squares regression was used. RESULTS: Results showed that 92% of expert judgments indicated the item content was clinically relevant, 90% indicated the content was appropriate for Step 2 CK, and 85% indicated the content was used in clinical practice. The regression indicated that more difficult items and more frequently used items are considered more appropriate for Step 2 CK. CONCLUSIONS: Results suggest that the majority of item content is clinically relevant and appropriate, thus providing validation support for Step 2 CK.

Clinical Competence↗
PubMed2003

Comparison of the cytotoxicity of clinically relevant cobalt-chromium and alumina ceramic wear particles in vitro.

Concern over polyethylene wear particle induced aseptic loosening of metal-on-polyethylene hip prostheses has led to renewed interest in alternative materials such as metal-on-metal and alumina ceramic-on-alumina ceramic for total hip replacement. This study compared the effects of clinically relevant cobalt-chromium and alumina ceramic wear particles on the viability of U937 histiocytes and L929 fibroblasts in vitro. Clinically relevant cobalt-chromium wear particles were generated using a flat pin-on-plate tribometer. The mean size of the clinically relevant metal particles was 29.5+/-6.3 nm (range 5-200 nm). Clinically relevant alumina ceramic particles were generated in the Leeds MkII anatomical hip simulator from a Mittelmieier prosthesis using micro-separation motion. This produced particles with a bimodal size distribution. The majority (98%) of the clinically relevant alumina ceramic wear debris was 5-20 nm in size. The cytotoxicity of the clinically relevant wear particles was compared to commercially available cobalt-chromium (9.87 microm+/-5.67) and alumina ceramic (0.503+/-0.19 microm) particles. The effects of the particles on the cells over a 5 day period at different particle volume (microm(3)) to cell number ratios were tested and viability determined using ATP-Lite(TM). Clinically relevant cobalt-chromium particles 50 and 5 microm(3) per cell reduced the viability of U937 cells by 97% and 42% and reduced the viability of L929 cells by 95% and 73%, respectively. At 50 microm(3) per cell, the clinically relevant ceramic particles reduced U937 cell viability by 18%. None of the other concentrations of the clinically relevant particles were toxic. The commercial cobalt-chromium and alumina particles did not affect the viability of either the U937 histiocytes or the L929 fibroblasts.Thus at equivalent particle volumes the clinically relevant cobalt-chromium particles were more toxic then the alumina ceramic particles. This study has emphasised the fact that the nature, size and volume of particles are important in assessing biological effects of wear debris on cells in vitro.

Aluminum↗