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Results for “Clinical Relevance”

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PubMed2002

Breast cancer cell contamination of blood stem cell products in patients with metastatic breast cancer: predictors and clinical relevance.

The incidence and clinical relevance of tumor cells contaminating the stem cell products of patients with advanced breast cancer treated with high-dose chemotherapy is uncertain because prior studies used small sample sizes and lacked standardization of the immunocytochemistry (ICC) detection method used. We evaluated blood stem cell and bone marrow samples obtained from 535 women with metastatic breast cancer who received high-dose chemotherapy and unmanipulated mobilized blood stem cell support. Of the patients tested, 20.6% and 26.3% had blood stem cell and bone marrow contamination, respectively. Blood stem cell contamination was significantly more frequent in patients with marrow involvement than in patients without marrow involvement (35% versus 18.4%, respectively; P = .009). In fact, according to multivariate analysis results, marrow involvement was the only significant predictor for blood stem cell product contamination. Patients without marrow involvement who had fewer apheresis procedures were also observed to have a significantly lower incidence rate of blood stem cell contamination than patients who had more procedures (P < or = .008), and patients who received combined chemotherapy and cytokine mobilization therapy had less contamination than patients who received cytokine alone (P = .0001). Combined mobilization therapy appears to be associated with a lower incidence of contamination as a result of fewer apheresis procedures rather than through an antitumor effect of chemotherapy (P < or = .001). Patients with ICC-negative blood stem cell products had significantly longer progression-free survival (PFS) and overall survival (OS) than did patients with ICC-positive blood stem cell products (median PFS, 401 versus 291 days, respectively, P = .007; median OS, 1060 versus 697 days, P = .009) . However, multivariate analysis did not reveal any significant independent predictors of survival outcomes. Thus, further study is needed to determine if contaminating tumor cells in the stem cell products of breast cancer patients ever directly impact survival outcomes or are only indicative of residual in vivo disease in high-dose chemotherapy recipients.

Adult↗

PubMed2000

Cerebrospinal fluid protein concentration in pediatric patients: defining clinically relevant reference values.

OBJECTIVES: To define clinically relevant reference ("normal") values for cerebrospinal fluid (CSF) protein concentrations in pediatric patients who were evaluated for meningitis by traditional criteria and by enterovirus-polymerase chain reaction (EV-PCR). DESIGN AND PATIENTS: A cohort of 906 consecutive pediatric patients to receive CSF analysis at St Louis Children's Hospital, St Louis, Mo, from June 1, 1998, to December 31,1998, was studied for clinical and laboratory data. Age-dependent CSF protein concentrations were then derived from a reference group of 225 patients in whom meningitis and other neurologic diseases were excluded by traditional clinical or laboratory criteria (excluding EV-PCR). Available CSF samples from 132 patients of the reference group were subsequently tested for EV-PCR. RESULTS: In the reference group, the CSF protein concentration was highest and most variable in neonates, with a maximum of approximately 1.0 g/L. Cerebrospinal fluid protein concentration decreased rapidly to a nadir by 6 months and remained low throughout childhood, rarely exceeding 0.3 g/L and, finally, increasing in adolescence toward adult values. Enterovirus- polymerase chain reaction was positive in CSF of 11% of the reference group, with EV-PCR-positive patients having significantly higher CSF protein concentrations than EV-PCR-negative patients aged between 4 months and 14 years. CONCLUSIONS: Reference values for CSF protein exhibit a characteristic age dependence in pediatric patients. Continued standard use of adult reference values in the pediatric population is inappropriate. The unexpected finding of a positive EV-PCR in patients not diagnosed with meningitis by traditional criteria further emphasizes the importance of selecting the most clinically relevant reference group for age and other variables when defining normal laboratory values. Arch Pediatr Adolesc Med. 2000;154:827-831

Adolescent↗

PubMed2006

Clinical relevance in anesthesia journals.

PURPOSE OF REVIEW: The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles. RECENT FINDINGS: In the last few years, more attention has been paid to evidence-based medicine in anesthesia. Several articles on the subject have focused on the need to base clinical decisions on sound research employing both methodological rigor and clinically relevant outcomes. The number of systematic reviews in anesthesia literature is increasing as well as the focus on diminishing the number of surrogate outcomes. It has been shown that the impact factor is not a valid measure of establishing the level of clinical relevance to a journal. SUMMARY: This review presents definitions of clinically relevant anesthesia articles. A clinically relevant article employs both methodological rigor and a clinically relevant outcome. The terms methodological rigor and clinical outcomes are fully discussed in the review as well as problems with journal impact factors.

Anesthesiology↗

PubMed2000

Oral paclitaxel and concurrent cyclosporin A: targeting clinically relevant systemic exposure to paclitaxel.

Oral paclitaxel is not inherently bioavailable because of the overexpression of P-glycoprotein by intestinal cells and the significant first-pass extraction by cytochrome P450-dependent processes. This study sought to simulate the toxicological and pharmacological profile of a clinically relevant schedule of paclitaxel administered on clinically relevant i.v. dosing schedules in patients with advanced solid malignancies using oral paclitaxel administered with cyclosporin A, an inhibitor of both P-glycoprotein and P450 CYP3A. Nine patients were treated with a single course of oral paclitaxel in its parenteral formulation at a paclitaxel dose level of 180, 360, or 540 mg. Cyclosporin A was administered at a dose of 5 mg/kg p.o. 1 h before and concurrently with oral paclitaxel. Blood sampling was performed to evaluate the pharmacokinetics of paclitaxel, 6-alpha-hydroxypaclitaxel, 3-p-hydroxypaclitaxel, and cyclosporin A. The pharmacokinetic behavior of paclitaxel was characterized using both compartmental and noncompartmental methods. Model-estimated parameters were used to simulate paclitaxel concentrations after once daily and twice daily oral administration of paclitaxel and cyclosporin A. Aside from an unpleasant taste, the oral regimen was well tolerated, and there were no grade 3 or 4 drug-related toxicities. The systemic exposure to paclitaxel, as assessed by maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) values, did not increase as the dose of paclitaxel was increased from 180 to 540 mg, and there was substantial interindividual variability (4-6-fold) at each dose level. Mean paclitaxel Cmax values approached plasma concentrations achieved with clinically relevant parenteral dose schedules, averaging 268+/-164 ng/ml. AUC values averaged 3306+/-1977 ng x h/ ml, which was significantly lower than AUC values achieved with clinically relevant i.v. paclitaxel dose schedules. However, computer simulations using pharmacokinetic parameters derived from the present study demonstrated that pharmacodynamically relevant steady-state plasma paclitaxel concentrations of at least 0.06 microM would be achieved after protracted once daily and twice daily dosing with oral paclitaxel and cyclosporin A. Paclitaxel metabolites were detectable in three patients, and the 6-alpha-hydroxypaclitaxel: paclitaxel and 3-p-hydroxypaclitaxel:paclitaxel AUC ratios averaged 0.63 and 0.86, respectively; these values were substantially higher than values reported in patients treated with i.v. paclitaxel. Oral paclitaxel was bioavailable in humans when administered in combination with oral cyclosporin A 5 mg/kg 1 h before and concurrently with paclitaxel treatment, and plasma paclitaxel concentrations achieved with this schedule were biologically relevant and approached concentrations attained with clinically relevant parenteral dose schedules. However, treatment of patients with oral paclitaxel using a single oral dose administration schedule failed to achieve sufficiently high systemic drug exposure and pharmacodynamic effects. In contrast, computer simulations demonstrated that clinically relevant pharmacodynamic effects are likely to be achieved with multiple once daily and twice daily oral paclitaxel-cyclosporin A dosing schedules.

Administration, Oral↗

PubMed2006

Applicability and clinical relevance of results in randomized controlled trials: the Cochrane review on exercise therapy for low back pain as an example.

STUDY DESIGN: A critical appraisal of the literature. OBJECTIVES: To increase awareness of the importance of applicability and clinical relevance of the results of randomized controlled trials (RCTs) in the field of spinal disorders by formulating a list of items for assessment of applicability and clinical relevance of results of RCTs. SUMMARY OF BACKGROUND DATA: In systematic reviews of randomized controlled trials (RCTs), critical appraisal of methodologic quality is considered important. Less attention has been paid to the assessment of the applicability and the clinical relevance of the results. METHODS: RCTs in an update of the Cochrane review on exercise therapy for low back pain were used. Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients: intervention and setting, outcome, effect size, and benefits related to adverse effects. Item 1 was met by 88% of the trials, but item 2 only by 51%, item 3 by 67%, item 4 by 35%, and item 5 by 0%. Subsequently, a more comprehensive list of items for the assessment of applicability and clinical relevance of results of RCTs was developed. These criteria were pilot tested on the RCTs. After pilot testing and a subsequent consensus meeting, the list of items was drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group. Changes were made in response to comments. RESULTS: The final list consists of 40 items. The items are ordered on two headings: Does the report enable the assessment of applicability? Are the study results clinically relevant? We present examples of informative and noninformative reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed. CONCLUSIONS: Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. The presented list of items may help clinicians reading RCTs and authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance of results.

Humans↗

PubMed1995

Clinical relevance of response and improvement in psychopharmacology: European College of Neuropsychopharmacology.

The use of responder categories may provide more clinically relevant information than mean differences on a severity scale but is not a definitive solution. Responder analysis is more useful in moderate illness than in mild or severe illness, depends on the timing of the analysis, and on the variance in the sample. Nevertheless, a statistically significant difference between drug and placebo treatment with respect to the percentage responders defined as a pre-established degree of reduction on a pivotal severity scale may provide the most objective information about clinical relevance yet available. Using distributions of categories of response may be less restrictive and provide a better description of results but more data are needed before conclusions can be reached. Effect size is an attractive, apparently simple method of establishing clinical relevance but criteria are lacking on cutoffs for accepting an effect size as relevant. There is a need for more information on patient samples, a better exploration of the conditions affecting response, and a better description of outcome than a single point. There are no accepted firm criteria for the clinical relevance of differences observed. There is insufficient precision in outcome measures as they currently used to set up rules. It is proposed that the criteria under discussion are interesting and need to be further investigated. More data are needed on the expected range of response, the range of size of effect of drugs, the range of response categories to drugs, and the conditions affecting response. This information is available in the large databases from clinical trial programmes of the pharmaceutical industry and a coordinated examination of available databases would provide a fruitful basis for arriving at a worthwhile estimate of the clinical relevance of psychotropic drug effects.

Europe↗

PubMedDate not supplied

Retrospective drug utilization review: incidence of clinically relevant potential drug-drug interactions in a large ambulatory population.

OBJECTIVE: To determine the incidence of clinically relevant potential drug-drug interactions (DDIs) in a large population of ambulatory patients utilizing a computerized, retrospective drug utilization review (DUR) program followed by clinical pharmacist audit. METHODS: The drug claims database included approximately 2.9 million patients with more than 30 million prescriptions dispensed in the 12-month period from September 2001 through August 2002. Cases were identified by a computerized, retrospective DUR program with embedded triggers to detect 69 prespecified potentially serious DDIs, with "serious" defined as an interaction that would likely require a change in therapy or use of additional clinical or laboratory monitoring. Two types of automated, computerized assessments were conducted: the first simply detected coprescribed drug pairs, and the second assessment used more sophisticated filters to reduce false positive alerts for coprescribed drug pairs. Clinical pharmacist audit then determined the final incidence of clinically relevant warnings; in this audit, coprescribed drug pairs were defined as clinically relevant if they could cause potentially serious DDIs. RESULTS: Eighteen drug pairs had insufficient cases for inclusion, leaving 51 drug pairs for evaluation. A total of 244,703 cases of potential DDIs were identified (0.8% of total prescription claims) by simple automated screens. More sophisticated DDI filters reduced the 244,703 potential DDIs by 70.8%, to a total of 65,544 pairs (0.2% of total prescription claims). Clinical pharmacist review reduced the number of potential DDIs by an additional 80.6%, to 12,722 drug pairs (0.04% of total prescription claims) deemed clinically relevant. The combination of sophisticated DDI filters and clinical pharmacist review reduced the incidence of potentially serious DDIs by 94.3%. CONCLUSION: The incidence of potentially serious DDIs is relatively low (less than 1%) among ambulatory patients; however, the incidence depends on the method of case finding. Retrospective DUR programs, especially those with additional automated filters or that utilize additional pharmacist review, appear to be important screening tools in determining true rates of coprescribed drug pairs that can lead to potentially serious DDIs.

Ambulatory Care↗

PubMed1980

The assessment of clinical competence on the emergency medicine specialty certification examination: the validity of clinically relevant multiple-choice items.

This study investigated the effect of clinically relevant multiple-choice item content on the valid discrimination or statistical separation of groups with known and different levels of experience and training in emergency medicine. Items for a high-clinical-relevance (HCR) subscale were chosen for their highest correlation with independent ratings of clinical performance on 12 simulated patient encounters relevant to emergency medicine. Low-clinical-relevance (LCR) subscale items were selected for their lowest correlation with the same criterion ratings. HCR was significantly more statistically discriminating of candidate groups which differed with respect to years of training and experience in emergency medicine. Additionally, the HCR subscale was more reliable and less difficult than the LCR subscale.

Adult↗

PubMed1992

[The clinical relevance of sonography in intensive care units].

336 sonographic examinations were performed with a portable ultrasound scanner on 217 patients in intensive-care units. In 302/336 (90%) cases, the region of clinical interest could be demonstrated completely or mostly by ultrasound. The clinical question could be answered by ultrasound in 270/310 (87%) cases partially. In 17/210 (5%) cases the clinical question could not be answered by ultrasound, in 26/336 (8%) cases there was no clinical question at all. 211/336 (63%) sonographic examinations were retrospectively classified as clinically relevant. A large part of clinically relevant examinations was found at the sonographic evaluation of the liver (100%), of the pericardium (96%), of the kidneys (89%), of the blood vessels (80%), of the gallbladder (78%), of the pleural space (76%) and on sonographic evaluation of patients with blunt abdominal trauma (91%). A relatively small part of clinically relevant examinations was found at sonographic evaluation of circumscribed or free intraabdominal fluid (59% resp. 57%), of cholestasis (53%) and of suspected neoplasm (11%). Sonographic examinations of the pancreas (40%) or the spleen (33%) and examinations without any clinical question (50%) also showed little clinical relevance.

Critical Care↗

PubMed2004

Clinically relevant levels of depressive symptoms in community-dwelling middle-aged African Americans.

OBJECTIVES: To identify the prevalence of and potentially modifiable risk factors for clinically relevant levels of depressive symptoms in a population-based sample of community-dwelling African Americans and the prevalence of treatment by prescription and alternative medications. DESIGN: Cross-sectional survey, 2000-01. SETTING: Community-based. PARTICIPANTS: Nine hundred ninety-eight noninstitutionalized African Americans in St. Louis, Missouri, born between 1936 and 1950. MEASUREMENTS: Depressive symptoms were measured using the 11-item Center for Epidemiologic Studies Depression scale (CES-D). Clinically relevant levels of depressive symptoms were defined as nine or more (equivalent to >/=16 on the 20-item CES-D). A comprehensive set of risk factors was considered that included three demographic variables, eight socioeconomic-access measures, four environmental factors, seven measures of functional status, 15 biomedical markers, one service utilization indicator, and three psychosocial measures. All analyses were weighted to the represented population. Treatment with an antidepressant was determined by examining subjects' medications compiled in their homes. RESULTS: Two hundred ten subjects (21.1%) had clinically relevant levels of depressive symptoms. Several multivariate logistic regression approaches were used for model building, which identified a consistent set of nine predictive factors: female sex (odds ratio adjusted (AOR) for all factors in the final model=1.52; 95% confidence interval (CI)=1.01-2.27), lower objective income (AOR=1.62, 95% CI=1.08-2.43), perceived income inadequacy (AOR=2.33, 95% CI=1.49-3.65), lower assessment of home environment (AOR=1.07 per scale point, 95% CI=1.01-1.12), limitations in visual acuity (AOR=1.12 per scale point, 95% CI=1.04-1.21), being severely underweight (AOR=2.52, 95% CI=1.02-6.20), being obese (AOR=1.72, 95% CI=1.16-2.54), being hospitalized in the previous year (AOR=2.25, 95% CI=1.45-3.49), and lower social support (AOR=1.20 per scale point, 95% CI=1.16-1.26). Of these, social support was the most important (adjusted standardized odds ratio =2.41). Forty-one (19.5%) of the subjects with clinically relevant levels of depressive symptoms were taking prescription antidepressants. CONCLUSION: The prevalence of clinically relevant levels of depressive symptoms in middle-aged African Americans was greater than that for the general U.S. population. Community-based health programs that screen for depression and refer individuals to clinical care sites with appropriately designed systems of care for depression management should be developed. For optimal effect, these programs should concentrate their efforts in socioeconomically disadvantaged areas and address socioeconomic factors such as income inadequacy and social support in addition to the biomedical risk factors. Given the pervasive adverse effects of depression, such interventions have the potential for significantly enhancing the health of African Americans in their later years and reducing current health disparities.

Black or African American↗

PubMed2005

Enzyme kinetics for clinically relevant CYP inhibition.

In vitro cytochrome P450 (CYP)-associated metabolic studies have been considered cost-effective for predicting the potential clinical drug-drug interactions (DDIs), one of the major attritions in drug development. The breakthroughs during the past decade in understanding the biochemistry of CYP-mediated biotransformation and molecular biology of CYP gene regulation in humans have provided the scientific bases for such endeavors in early drug development. In this review, the enzyme kinetics of CYP inhibitions is described, with the primary focus on the ones proven with clinical relevance, namely the competitive inhibition and mechanism-based inactivation (MBI). Competitive CYP inhibition, the most often detected reversible inhibition, is well understood and has been studied extensively both in vitro and in clinical setting. Recently, MBI has received increasing attention. It has been recognized that MBI could occur more often than anticipated, due in part to the redox cycling-allied enzymatic action of CYPs. As commonly as an irreversible inhibition, MBI would inactivate the target proteins, and thus would be generally considered of high potential for causing clinical DDI. Moreover, the reversible inhibitions other than the competitive, namely noncompetitive, uncompetitive and mixed, were also documented for the important drug-metabolizing CYP members, particularly CYP1A2 and CYP2C9. Finally, the unusual kinetic interactions, which did not follow the Michaelis-Menten (M-M) kinetics, were detected in vitro for the majority of drug-metabolizing CYP members, and manifested for CYP3A4. However, the clinical relevance of the interactions involving the unusual CYP kinetics has not yet been fully understood. Nonetheless, the reversibility and inhibitory potency should be considered as the major determinants of the clinical relevance, particularly in combination with the therapeutic exposure levels. With rapid expansion of knowledge and technology, the evaluation of the clinically relevant CYP-associated DDIs in vitro is not only desirable but also achievable.

Animals↗

PubMed1989

Pelvic manifestations of diffuse idiopathic skeletal hyperostosis (DISH): are they clinically relevant?

This is a cross-sectional, case-controlled study on the clinical relevance of diffuse idiopathic skeletal hyperostosis (DISH) in relation to the pelvic girdle. Thirty-two rheumatology patients with DISH were compared with 35 dermatology control subjects in respect to the clinical parameters pain and passive hip joint motion in a standardized manner. There were no significant differences between the two groups, indicating no major clinical relevance of DISH in the pelvic region. In a second study, the radiographs of 23 DISH probands were compared blindly with 23 matched controls. The only significant difference was a much higher degree of severe juxtaarticular bone formation in DISH probands. The majority of these spurs proved to be asymptomatic and did not affect the range of passive hip joint mobility. DISH is a frequently seen, often radiologically very impressive phenomenon of little clinical relevance, at least in the pelvic area.

Aged↗

PubMed1997

Clinical relevance of culture: why, how, and when.

BACKGROUND: Culture for Helicobacter pylori is undertaken for research and industrial and diagnostic purposes, including antibiotic sensitivity testing of the isolate. The objective of this review is to evaluate the clinical relevance of culture for H. pylori. METHODS: The clinical relevance of culture for H. pylori is explored by a critical review of the literature. RESULTS: Primary isolation of the organism from specimens has direct clinical relevance in terms both of detecting colonization and of determining the antibiotic sensitivity of the isolate, which information is used for patient management and for local, national, or international prevalence rates and trends. It is suggested that when endoscopy is undertaken as part of a management algorithm, a biopsy should always be obtained for culture and sensitivity testing. H. pylori can be cultured from specimens on a variety of selective media, which are selected on the basis of the growth requirement of the organism. Standardization of culture media, culturing methods, and interpretive values for sensitivity testing of isolated strains is lacking. Culture of H. pylori on an industrial scale requires fermenter technology and media that maximize the production of bacterial products that can be easily purified and used as diagnostic or therapeutic agents. CONCLUSIONS: Culture of laboratory strains of H. pylori for investigation of the organism's metabolism and virulence factors has only indirect clinical relevance but has led to the identification of targets for therapeutic intervention.

Bacteriological Techniques↗

PubMed2001

Positive patch-test reactions to para-phenylenediamine, their clinical relevance and the concept of clinical tolerance.

406 patients were patch tested over an 18-month period (January 1998 to June 1999) at a dermatology referral centre. 33 patients (8.1%) had a positive reaction to para-phenylenediamine (PPD). 20 patients were experiencing PPD hair dye dermatitis (present relevance, 61%), 2 were using PPD hair dyes without developing dermatitis (clinical tolerance, 6%), 4 had previously used PPD hair dyes with dermatitis in the past (past relevance, 12%), 3 had previously used PPD hair dyes without dermatitis (past exposure, 9%) and 4 had no known exposure to PPD (unknown relevance, 12%). Of the 20 patients whose test results were of present relevance, 17 avoided PPD hair dyes, resulting in total clearance of the dermatitis in all except 3, who had concurrent endogenous eczema. 3 continued using PPD hair dyes: 2 had recurrent contact dermatitis and 1 avoided dermatitis with meticulous technique. The 2 patients with clinical tolerance continued using PPD hair dyes with no dermatitis.

Adult↗

PubMed2006

Magnetic resonance urethrography in comparison to retrograde urethrography in diagnosis of male urethral strictures: is it clinically relevant?

OBJECTIVE: To compare the clinical relevance of retrograde urethrography (RUG) and magnetic resonance (MR) urethrography in evaluating male urethral strictures. METHODS: Between January and April 2004, 20 men were referred to our institute for management of urethral strictures. The patients were investigated by conventional RUG and multiformat MR urethrography. The patients were examined by urethroscopy under anesthesia to be followed by definitive endoscopic or open operative intervention. The radiologic data were compared by endoscopic as well as operative findings in all the patients. RESULTS: Ten patients were managed by visual internal urethrotomy (VIU) and two by dilatation under anesthesia; two showed normal urethral caliber. Four patients required open urethral reconstructive procedures. Two patients underwent radical cystectomy and cutaneous diversion because of associated bladder or urethral malignancy. Although overall accuracy for diagnosis of urethral strictures was equal between both modalities (85%), MR urethrography provided extra clinical data in seven patients (35%). It was superior to RUG in judging the urethral stricture length in three patients, diagnosing a urethral tumor in one, detecting associated bladder mass in one, characterizing the site of urethra-rectal fistula in one, and accurately delineating the proximal urethra in the last patient. Unlike RUG, MR urethrography provided adequate information about the degree of spongiofibrosis in all patients. CONCLUSION: MR urethrography is a promising tool for defining male urethral strictures and can provide extra guidance for treatment planning that cannot be obtained with RUG.

Adolescent↗

PubMedDate not supplied

Validation of the nighttime symptoms score as a clinically relevant measure of allergic rhinitis.

The aim of this study was to validate the nighttime symptoms score (NSS), which incorporates individual scores for difficulty going to sleep and nighttime awakening caused by nasal symptoms and nasal congestion on awakening, as a clinically relevant measure of allergic rhinitis (AR). Fifty-five general season AR (SAR) symptom items were generated by interviews with 14 patients with symptomatic SAR without concomitant asthma for use in an Importance Rating Questionnaire (IRQ). A second group of patients (n = 83) with symptomatic AR without asthma rated the importance of each item on the IRQ. Correlation coefficients were calculated to examine the relationships between the six sleep quality questions on the IRQ and the other AR symptoms and between the symptom questions of the NSS, the Daytime Nasal Symptoms Score (DNSS), and the individual domains of the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). The majority (94%) of patients with active AR reported some degree of symptoms relating to sleep quality. The six sleep quality items on the IRQ were selected by 71-84% of patients. The sleep quality items were more highly correlated with each other (r = 0.48-0.85) than with the four items of the DNSS (r = 0.01-0.42). There was a moderate-to-strong correlation of the RQLQ sleep domain with the two sleep questions of the NSS (r = 0.44-0.57). The individual symptom questions of the NSS and the DNSS were only moderately correlated with each other. Sleep quality questions measure aspects of SAR that are not captured by daytime SAR symptoms. The results show that the NSS is a valid and relevant clinical measure of the impact of nighttime sleep disturbance on AR patients.

Adolescent↗

PubMed2006

Detrimental antidepressant drug-drug interactions: are they clinically relevant?

This paper takes the position that detrimental drug-drug interactions (DDIs) involving antidepressants are clinically relevant. In doing so, it begins with a definition of the terms: drug-drug interaction, detrimental, and clinical relevance. It then discusses the issues of proof and provides an overview of the clinically relevant DDIs involving antidepressants. It also gives examples involving drugs besides antidepressants based on the premise that the underlying principles are applicable regardless of the therapeutic classes of the drugs involved.

Animals↗

PubMed2006

Clinical relevance of rehabilitation programs for patients with idiopathic Parkinson syndrome. II: Symptom-specific therapeutic approaches.

Clinical symptoms of the idiopathic Parkinson's syndrome (IPS) are numerous. Clinical experience as well as pharmacological research identified symptoms not responsive to dopaminergic stimulation. These symptoms in particular were the target of rehabilitative therapy approaches. Several of these approaches have been evaluated in prospective studies. In the present paper, these studies and the respective therapeutic interventions were categorized and rated concerning their clinical relevance and their study design supporting a differential therapeutic approach. Symptoms were arranged relating to their clinical relevance and specific therapeutic approaches were described and rated. The rating was based on a novel developed approach to check for clinical relevance. In addition, areas in need of further and more intensive scientific research, as depression, cognitive deficits, and tremor, were identified. On the contrary, conclusive therapeutic approaches were available for the treatment of symptoms like gait and postural disturbances and dysarthria. Some advice for the therapy of muscular weakness, dexterity problems and dysphagia was given, but further studies are warranted in these fields.

Clinical Trials as Topic↗