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PubMed2004

Genetic counseling in carriers of reciprocal chromosomal translocations involving long arm of chromosome 16.

Families with balanced chromosomal changes ascertained by unbalanced progeny, miscarriages, or by chance are interested in their probability for unbalanced offspring and other unfavorable pregnancy outcomes. This is usually done based on the original data published by Stengel-Rutkowski et al. several decades ago. That data set has never been updated. It is particularly true for the subgroup with low number of observations, to which belong reciprocal chromosomal translocations (RCTs) with breakpoint in an interstitial segment of 16q. The 11 pedigrees from original data together with the new 18 pedigrees of RCT carriers at risk of single-segment imbalance detected among 100 pedigrees of RCT carriers with breakpoint position at 16q were used for re-evaluation of the probability estimation for unbalanced offspring at birth and at second trimester of prenatal diagnosis, published in 1988. The new probability rate for unbalanced offspring after 2 : 2 disjunction and adjacent-1 segregation for the total group of pedigrees was 4 +/- 3.9% (1/25). In addition, the probability estimate for unbalanced fetuses at second trimester of prenatal diagnosis was calculated as 2/11, i.e. 18.2 +/- 11.6%. The probability rates for miscarriages and stillbirths/early deaths were about 16 +/- 7.3% (4/25) and <2% (0/25), respectively. Considering different segment lengths of 16q, higher probability rate (0/8, i.e. <6.1%) for maternal RCT carriers at risk of distal 16q segment imbalance (shorter segment) was obtained in comparison with the rate (0/10, i.e. <4.8%) for RCT at risk of proximal segment imbalance (longer segment). It supports findings obtained from the original data for RCT with other chromosomes, where the probability for unbalanced offspring generally increased with decreasing length of the segments involved in RCT. Our results were applied for five new families with RCT involving 16q, namely three at risk of single-segment imbalance [t(8;16)(q24.3;q22)GTG, ish(wcp8+,wcp16+;wcp8-,wcp16+), t(11;16)(q25;q22)GTG, and t(11;16)(q25;q13)GTG] and two with RCT at risk of double-segment imbalance [t(16;19)(q13;q13.3)GTG, isht(16;19)(q13;q13.3) (D16Z3+,16QTEL013-D19S238E+,TEL19pR-; D16Z3-, D19S238E-,TEL19pR+), and t(16;20)(q11.1;q12)GTG, m ish,t(16;20)(wcp16+,wcp20+;wcp16+,wcp20+)]. They have been presented in details to illustrate how the available empiric data could be used in practice for genetic counseling.

Chromosomes, Human, Pair 16↗
PubMed2000

Returning to the bedside: using the history and physical examination to identify rotator cuff tears.

OBJECTIVES: To determine the value of elements of the bedside history and physical examination in predicting arthrography results in older patients with suspected rotator cuff tear (RCT). DESIGN: Retrospective chart review SETTING: Orthopedic practice limited to disorders of the shoulder PARTICIPANTS: 448 consecutive patients with suspected RCT referred for arthrography over a 4-year period MAIN OUTCOME MEASURE: Presence of partial or complete RCT on arthrogram RESULTS: 301 patients (67.2%) had evidence of complete or partial RCT. Clinical findings in the univariate analysis most closely associated with rotator cuff tear included infra- and supraspinatus atrophy (P < .001), weakness with either elevation (P < .001) or external rotation (P < .001), arc of pain (P = .004), and impingement sign (P = .01). Stepwise logistic regression based on a derivation dataset (n = 191) showed that weakness with external rotation (Adjusted Odds Ratio (AOR) 6.96 (3.09, 13.03)), age > or = 65 (AOR 4.05(2.47, 16.07)), and night pain (AOR 2.61 (1.004, 7.39)) best predicted the presence of RCT. A five-point scoring system developed from this model was applied in the remaining patient sample (n = 216) to test validity. No significant differences in performance were noted using ROC curve comparison. Using likelihood ratios, a clinical score = 4 was superior in predicting RCT to the diagnostic prediction of an expert clinician. This score had specificity equivalent to magnetic resonance imaging or ultrasonography in diagnosis of RCT. CONCLUSIONS: The presence of three simple features in the history and physical examination of the shoulder can identify RCT efficiently. This approach offers a valuable strategy to diagnosis at the bedside without compromising sensitivity or specificity.

Aged↗
PubMed1997

Community mothers' programme: extension to the travelling community in Ireland.

STUDY OBJECTIVE: To see whether the community mothers' programme, using lay volunteer mothers to deliver a childhood development programme, could be extended successfully to the travelling community in Ireland. DESIGN: This was a prospective study of the travelling community; comparisons were made with results of a previous randomised trial of settled mothers. SETTING: A regional health authority in Ireland. PARTICIPANTS: These comprised 39 traveller and 127 settled intervention mother/ infant pairs (randomised controlled trial (RCT) intervention); settled community mothers; 105 settled control pairs (RCT control). All mothers received standard support; traveller and RCT intervention groups also received the services of a community mother. MAIN RESULTS: The travellers' sociodemographic profile differed significantly from the other groups. At the end of the study, traveller and intervention children were exposed to more cognitive games and nursery rhymes. There were significant differences in the proportions who received all three shots of their primary immunisation schedule before 12 months of age and who received "three in one" vaccination, with traveller children doing least well. The diet of traveller children surpassed that of RCT controls in all food groups except fruit; they were less likely to begin cows' milk before 26 weeks of age. Traveller mothers' diet was superior to that of RCT control and similar to RCT intervention mothers. Traveller and RCT intervention mothers were less likely to feel tired, feel miserable, and want to stay indoors than RCT control mothers. CONCLUSIONS: The results of the community mothers' programme in the travelling community are encouraging; poor immunisation uptake remains a challenge.

Accidents↗
PubMed1999

Assessing the laryngeal cough reflex and the risk of developing pneumonia after stroke: an interhospital comparison.

BACKGROUND AND PURPOSE: We sought to evaluate the efficacy of testing the laryngeal cough reflex in identifying pneumonia risk in acute stroke patients. METHODS: We performed a prospective study of 400 consecutive acute stroke patients examined using the reflex cough test (RCT) compared with 204 consecutive acute stroke patients from a sister facility examined without using the RCT. The binary end point for the study outcome was the development of pneumonia. RESULTS: Of the 400 patients examined with the RCT, 5 developed pneumonia. Of the 204 patients examined without the RCT, 27 developed pneumonia (P<0.001). Three of the 27 patients died in the rehabilitation hospital of respiratory failure secondary to pneumonia. Seven others were transferred to the emergency department with acute respiratory distress. Power analysis for this comparison was 0.99. There were no other significant differences between the 2 groups. CONCLUSIONS: A normal RCT after an acute stroke indicates a neurologically intact laryngeal cough reflex, a protected airway, and a low risk for developing aspiration pneumonia with oral feeding. An abnormal RCT indicates risk of an unprotected airway and an increased incidence of aspiration pneumonia. Alternate feeding strategies and preventive measures are necessary with an abnormal RCT. Clinical treatment algorithm and prescription of food, fluids, and medications are discussed on the basis of RCT results.

Algorithms↗
PubMed2000

Comparison of outcomes for clients in randomized versus open trials of treatment for alcohol use disorders.

OBJECTIVE: There has been continuing concern that clients who accept randomization into a controlled trial may not be representative of those in noncontrolled trials or ordinary treatment situations. However, it is not possible to test the impact of randomization through a randomized trial. Two parallel studies conducted at the same treatment facility provided an opportunity for a quasi-experimental study to evaluate whether participation in a controlled trial itself affects treatment outcome. METHOD: Two concomitant samples of clients were enrolled during overlapping recruitment periods: one (n = 226) into a randomized clinical trial (RCT) and the other (n = 122) offered treatment as usual (non-RCT). Both samples were given extensive baseline and follow-up assessment. RESULTS: Baseline assessment indicated demographic similarity of the two samples, with somewhat higher problem severity in the non-RCT sample, consistent with the RCT selection criteria. Client retention in treatment was somewhat comparable, and follow-up rates exceeded 90% in both studies. Overall outcomes did not differ for the RCT and non-RCT samples. CONCLUSIONS: It appeared that clients enrolled into an RCT did not differ from those receiving ordinary treatment. Retention was similarly high in both studies, clients completed a comparable number of outpatient sessions, and the number of informal treatment sessions attended during the 6 months of follow-up was comparable. There are some aspects of this study that limit the ability to draw firmer conclusions but despite some pretreatment differences, participation in the RCT did not itself exert an apparent effect on aggregate treatment outcomes.

Adult↗
PubMed2004

Outcomes of vital primary incisor ferric sulfate pulpotomy and root canal therapy.

PURPOSE: To compare ferric sulfate (FS) pulpotomy and primary tooth root canal therapy (RCT) in cariously exposed vital pulps of primary incisors. METHODS: A total of 133 incisors in 50 children were randomly selected to be treated by FS pulpotomy (64) or RCT (69). RESULTS: Two years after treatment, 77 incisors (41 FS pulpotomy, 36 RCT) were available for clinical and radiographic examination. There was no clinical evidence of pathosis in 78% of FS pulpotomy-treated and 100% of RCT-treated incisors. Two independent pediatric dentists evaluated periapical radiographs of the treated incisors. Incisors were classified into 1 of 4 treatment outcomes: N, normal treated incisor; H, nonpathologic radiographic change present; PO, pathologic change present, but not requiring immediate extraction; PX, pathologic change present, extract immediately. Survival analysis was applied. A moderate level of agreement between raters was found for incisors with outcome PX (K = 0.54). Intra-rater reliability was substantial for incisors with outcome PX (K = 0.61). No difference was demonstrated in the proportion of FS pulpotomy- and RCT-treated incisors rated PX at the 2-year recall (x2 = 0.6). RCT incisors demonstrated a significantly higher survival rate than FS pulpotomy incisors at 2 years (p = 0.04). CONCLUSIONS: Treatment outcomes for RCT incisors were not significantly different from FS pulpotomy-treated incisors at 2 years; however, at 2 years the survival rate of RCT incisors was statistically greater than that of FS pulpotomy-treated incisors.

Child, Preschool↗
PubMed2006

The handsearching of 2 medical journals of Bahrain for reports of randomized controlled trials.

OBJECTIVE: To identify reports of randomized trials by handsearching 2 Bahrain medical journals, which are indexed in the biomedical database EMBASE and to determine any added value of the handsearching by comparing the reports found by handsearching with what would have been found by searching EMBASE to examine (i) the precision and sensitivity of the EMBASE index term Randomized Controlled Trial (RCT) and (ii) The Cochrane Collaboration's systematic electronic search of EMBASE (which uses 4 index terms and 9 free-text terms). METHODS: All issues of the Bahrain Medical Bulletin (BMB) (1979-2004) and the Journal of the Bahrain Medical Society (JBMS) (1989-2004) were handsearched in February 2005 for reports of RCTs or Controlled Clinical Trials (CCTs), according to Cochrane eligibility criteria. RESULTS: Out of 395 articles in BMB we found reports of 12 RCTs and 4 CCTs. Distribution by country of corresponding author: Jordan (4 RCTs, one CCT), Bahrain (one RCT, one CCT), India (3 RCTs, one CCT), Kuwait (one CCT), Saudi Arabia (2 RCTs), USA/Bahrain (one RCT), and Oman (one RCT); and by specialty: Anesthesia (8), Surgery (1) Pediatrics (1), Radiotherapy (1), Community Medicine (1), Sports Medicine (1), Obstetrics/Gynecology (3). The Journal of the Bahrain Medical Society included reports of 14 RCTs and 3 CCTs, out of 97 articles. Distribution by country of corresponding author: Jordan (9 RCTs, 2 CCTs), Bahrain (3 RCTs), Egypt (one RCT), Kuwait (one RCT), and Saudi Arabia (one RCT); and by specialty: Anesthesia (7), General Surgery (3), Obstetrics/Gynecology (1), Radiotherapy (1), Pediatrics (1), Orthopaedic Surgery (1), Education (1) Ear Nose and Throat (1) Ophthalmology (1). Overall, of the 33 reports of trials found by handsearching both journals, only 23 were included in EMBASE of which only 6 had been indexed with the term RCT. Of the 23 reports of trials included in EMBASE, 16 had been identified in the Collaboration s systematic search of EMBASE. Two reports of trials could have been retrieved by this search but there was insufficient information in the title and abstract to code these as trials. The EMBASE records for the remaining 5 reports of trials did not contain terms currently used by The Cochrane Collaboration to identify reports of randomized trials in this database. CONCLUSION: The handsearching of these journals will help minimize publication bias by locating randomized trials not previously identified and, through their inclusion in the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, will ensure reports of randomized trials will not remain buried through indexing bias.

Bahrain↗
PubMed1989

Significance of incisional biopsy in breast carcinoma: results from a clinical trial with intended excisional biopsy.

The recurrence-free survival rates (RFS) after one-stage mastectomy and partial axillary dissection in 1242 low risk breast cancer patients with invasive ductal carcinoma with or without residual cancer tissue (RCT) in the wall of the biopsy cavity were compared. RFS was significantly lower in patients with RCT (RCT-positive) whether premenopausal (n = 416) or postmenopausal (n = 826). By applying the Cox multivariate analysis on RCT and various known prognostic criteria, the incidence rates for RCT-positive patients relative to RCT-negative patients were estimated. The relative risk by RCT-positivity was in the order of 1.45, indicating that RCT is an independent risk factor contributing an increased risk of recurrence of about 45%.

Axilla↗
PubMed2002

Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study.

BACKGROUND: Accelerated bone loss after stopping hormone therapy (HRT) is postulated to explain the lack of hip-fracture protection conferred by former HRT use. The abbreviation HRT (traditionally standing for "hormone replacement therapy") is used herein because of its wide recognition in the field. However, the pharmacological doses of estrogens and progestins used are not truly "replacement" in nature. OBJECTIVES: To determine whether women lose bone mineral density (BMD) after stopping HRT; to assess whether their rate of loss is significantly greater than that of women not undergoing HRT; and to determine whether long-term HRT is associated with continued gains in BMD. METHODS: A total of 495 women who were adherent to assigned treatment in the 3-year Postmenopausal Estrogen/Progestin Interventions randomized controlled trial (PEPI-RCT) and who had an additional BMD measurement during the PEPI Safety Follow-up Study were observed for an average of 3 years during and 4 years after the PEPI-RCT. RESULTS: Women who stopped HRT after 1 year during the PEPI-RCT had annual rates of BMD change of -0.54% (hip) and -0.81% (spine) during the following 2 years. Those who underwent HRT for 3 years during the PEPI-RCT and then discontinued it had annual changes of -1.01% (hip) and -1.04% (spine). Rates of BMD loss among women who stopped HRT during or after the PEPI-RCT did not differ significantly from those of women who did not undergo HRT, who lost bone at a rate of approximately 1% yearly during the first year of the PEPI-RCT and about half that rate afterward. Women who continued HRT after the PEPI-RCT did not show additional BMD gains. CONCLUSIONS: Our results do not support the hypothesis that bone is lost at an unusually fast rate after discontinuation of HRT, nor do they suggest that longer-term HRT leads to additional BMD gain beyond that evident after 3 years.

Bone Density↗
PubMed1993

Planned segmentectomy. A necessity for breast carcinoma.

OBJECTIVE AND DESIGN: Some surgeons consider excisional biopsy with gross negative margins to be adequate surgical therapy for breast carcinomas, if followed by axillary dissection and radiation. To test our hypothesis that breast carcinoma necessitates planned operation, we reviewed the incidence of residual cancer tissue (RCT) and the significance of positive margins following excisional breast biopsy and segmentectomy. SETTING, PATIENTS, AND INTERVENTION/OUTCOME MEASURES: Using the clinical database of our multidisciplinary cancer center, we examined the tumor status of segmentectomy specimens from 375 patients treated for breast carcinoma during the past 10 years. All patients underwent excisional biopsy of the tumor mass before definitive treatment with segmentectomy and axillary dissection. Median follow-up was 32 months. RESULTS: The 284 patients (76%) whose segmentectomy specimens contained residual tumor (RCT-positive patients) had a larger median tumor diameter than RCT-negative patients (2 vs 1 cm, P < .01). Patients with tumor-positive axillary lymph nodes were more likely to be RCT positive (P < .001). Tumors of RCT-positive patients were more frequently identified by physical examination, whereas those of RCT-negative patients were more frequently identified by mammography (P < .001). Overall recurrence rate was 7% (26/384). Recurrence-free survival rates were statistically related to tumor status of the segmentectomy margins (P < .025) but not to RCT in the segmentectomy specimen. CONCLUSION: Diagnostic breast biopsy is not a substitute for planned excision to remove all malignant tissue. Anything less than a preconceived surgical procedure may leave a significant amount of malignant tissue.

Adult↗
PubMed2006

Polyunsaturated fatty acid supplementation for schizophrenia.

BACKGROUND: Limited evidence supports a hypothesis suggesting that schizophrenic symptoms may be the result of altered neuronal membrane structure and metabolism. The structure and metabolism is dependent on blood plasma levels of certain essential fatty acids and their metabolites. OBJECTIVES: To review the effects of polyunsaturated fatty acids for people with schizophrenia. SEARCH STRATEGY: We have updated the initial searches of 1998 and 2002 (Cochrane Schizophrenia Group's Register, July 2005), and where necessary, we contacted authors and relevant pharmaceutical companies. SELECTION CRITERIA: We included all randomised clinical trials of polyunsaturated fatty acid treatment for schizophrenia. DATA COLLECTION AND ANALYSIS: Working independently, we selected studies for quality assessment and extracted relevant data. We analysed on an intention-to-treat basis. Where possible and appropriate we calculated the Relative Risk (RR) and their 95% confidence intervals (CI) and estimated the number needed to treat (NNT). For continuous data we calculated weighted mean differences (WMD) and their 95% confidence intervals. We also inspected the data for heterogeneity. MAIN RESULTS: When any dose omega-3 (E-EPA or EPA) is compared with placebo, small short trials suggest that the need for neuroleptics appears to be reduced for people allocated omega-3 supplementation (n=30, 1 RCT, RR 0.73 CI 0.54 to 1.00) and mental state may improve (n=30, 1 RCT, RR not gaining 25% change in PANSS scores 0.54 CI 0.30 to 0.96, NNT3 CI 2-29). There are no differences in the number of people leaving the study early (n=271, 4 RCTs, RR 0.91 CI 0.36 to 2.33). There are few data on the comparison of any dose omega-6 (GLA) with placebo. For movement disorder outcomes, the only small study we found does not show any difference for average short-term endpoint AIMS score (n=16, 1 RCT, MD 1.30 CI -1.96 to 4.56). When any dose omega 3 (E-EPA or EPA) is compared with any dose omega-3 (DHA) there is no clear difference for mental state outcome of not gaining 25% change in PANSS scores (n=31, 1 RCT, RR 0.66 CI 0.39 to 1.11). When different doses of omega-3 (E-EPA) are compared with placebo there are no differences in measures of global and mental state between the studies. For the outcome of 'experiencing at least one adverse effect' no differences between groups are found for any dose (1g/day E-EPA vs placebo n=63 1 RCT, RR 0.97 CI 0.60 to 1.56; 2g/day E-EPA vs placebo n=63 1 RCT, RR 0.67 CI 0.37 to 1.20; 4g/day E-EPA vs placebo n=58, 1 RCT, RR 1.15 CI 0.72 to 1.82). AUTHORS' CONCLUSIONS: Two updates of this review have resulted in more included studies but relatively little useful additional data. The results remain inconclusive. The new trials all compare the omega-3 polyunsaturated fatty acids, in particular eicosapentaenoic acid and its ester, ethyl-eicosapentaenoic acid. The use of omega-3 polyunsaturated fatty acids for schizophrenia still remains experimental and this review highlights the need for large well designed, conducted and reported studies.

Antipsychotic Agents↗
PubMed1993

Attachment to extracellular matrix molecules by cells differing in the expression of osteoblastic traits.

Two sets of clonal cell populations differing in the expression of osteoblastic traits, the rat osteosarcoma cell lines ROS 17/2.8 and ROS 25/1 and the immortalized fetal rat calvarial cell lines RCT-1 and RCT-3, were compared for their ability to attach to a series of extracellular matrix (ECM) constituents in vitro. Both osteoblastic (ROS 17/2.8, RCT-3) and nonosteoblastic (ROS 25/1, RCT-1) cell lines attached in a time- and concentration-dependent manner to plates coated with fibronectin (FN), osteopontin (OP), type I collagen (Col I), type IV collagen (Col IV), and laminin (LN) but only weakly to osteocalcin (OC) and thrombospondin (TSP). In both systems, the osteoblastic and nonosteoblastic clones attached identically to FN. Both ROS 17/2.8 and ROS 25/1 attached to similar molar amounts of substrate with the same preference order: FN > LN > Col I > or = Col IV. Maximal ROS 17/2.8 attachment to OP was > or = Col I but required approximately 2.5 times more substrate. ROS 25/1 attached less effectively than ROS 17/2.8 to most non-FN substrates. RCT-3 cells attached similarly to ROS 17/2.8 except that the preference order for Col I and LN was reversed and attachment to OP was lower than for ROS 17/2.8 RCT-1 cells attached best to Col I rather than FN, and equaled or surpassed RCT-3 in attachment to other non-FN substrates. Thus in these experimental systems, cells expressing an osteoblast-like phenotype exhibited generally similar ECM attachment properties. Their nonosteoblastic counterparts recognized the same spectrum of ECM constituents but differed from the osteoblastic cells and from each other in the effectiveness of their attachment to substrates other than FN.

Animals↗
PubMed2005

Sudden cardiac death unresponsive to implantable defibrillator therapy: an urgent target for clinicians, industry and government.

A major expansion in utilization of implantable cardioverter-defibrillators (ICDs) is anticipated based on the results of randomized clinical trials (RCT) that demonstrate increased survival in a sizable population of patients with reduced left ventricular function. However, if RCT accurately reflect clinical practice, then a substantial proportion of patients will die suddenly despite ICD implantation. ICD-unresponsive sudden cardiac death (SCD) has been recognized since the initial ICD experience. Yet, despite 25 years of technical advances, the frequency of ICD-unresponsive SCD has not declined. Pooled analysis of RCT indicates a crude rate of ICD-unresponsive SCD of 5%. This may not cause alarm in an average practice, but it comprises about 30% of cardiac deaths. Meta-analyses of RCT show that ICD therapy is associated with a relative risk reduction of SCD of approximately 60%, far less than the greater than 90% efficacy that many expect. The suboptimal performance of ICD therapy accounts for the failure of some RCT to achieve statistically significant effects on survival. The number of patients with ICD-unresponsive SCD is highly correlated with the number of cardiac deaths among control patients as well as ICD recipients. Otherwise, no definite patterns have emerged that clearly distinguish this mode of demise from other modes of cardiac death. Retrospective post-hoc analyses have not revealed distinguishing characteristics of patients with ICD-unresponsive SCD with respect to clinical variables, pre-terminal symptoms or to the setting of the terminal event. Despite advanced storage capabilities of implanted devices, almost no information has become available from RCT regarding the terminal rhythm or the response of the ICD. These observations have implications for clinical management and research. Candidates for ICD implantation based on RCT should be accurately informed about the residual risk of SCD. Investigators seeking to identify populations likely to benefit from ICD therapy based on SCD incidence should recognize that a significant fraction may not respond to ICD therapy. Reducing the incidence of ICD-unresponsive SCD would substantially improve survival and cost-effectiveness related to ICD therapy. Close cooperation between clinicians, investigators and representatives of industry and government is urgently needed to develop strategies to identify patients prone to ICD-unresponsive SCD, to determine its mechanisms and to develop methods of prevention and treatment.

Death, Sudden, Cardiac↗
PubMed2004

Stage-III NSClC: multimodality therapy for inoperable tumours.

The combination of radiotherapy and chemotherapy (RCT) has improved the treatment results of patients with inoperable stage-III NSCLC in comparison to irradiation alone and is seen as the standard treatment at present. Concomitant RCT was significantly superior to sequential RCT in three of four studies, so that the simultaneous therapy sequence is seen today as the best modality. Nevertheless, the results, with median survival times of 15-18 months and a 5-year survival rate between 10 and 20%, are still not satisfactory so that further possibilities of optimisation are being looked for: --Can the results of concomitant RCT be improved by an induction chemotherapy or subsequent chemotherapy? --Is there an additional benefit of operative measures for tumours which through the application of RCT get operable? --What is the additional benefit of biological response modifiers applied together with RCT? --Is there a place for RCT of elderly patients or patients in poor general condition? The rationale as well as the initial results shall be discussed in this overview.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Cerebral oxygenation declines at exercise intensities above the respiratory compensation threshold.

During incremental exercise PaCO2 and PETCO2 begin to decline at the respiratory compensation threshold (RCT-GEX). Since PaCO2 alters cerebral blood flow it was hypothesized that there would be a systematic decline in cerebral oxygenation (Cox) measured by near infrared spectroscopy above the RCT (RCT-NIRS). Cardiorespiratory and NIRS responses were simultaneously monitored from the left frontal lobe during incremental exercise in 17 men. All subjects showed a decline in Cox above the RCT-GEX with a 20-40 s delay. Significant differences (P<0.01) were observed between the RCT-GEX and RCT-NIRS for time (9.83 versus 10.39 min), power (198 versus 212 W) and oxygen uptake (2.31 versus 2.43 L min-1). Intra-class correlations for power and absolute VO2 were 0.97 and 0.98, respectively. Bland-Altman analysis revealed no outliers for any of the variables. The results suggested that the decrease in Cox observed above the RCT was most likely due to a reduction in cerebral blood flow mediated by a decline in PaCO2. This decline in Cox could reduce neuronal activation thereby limiting maximal exercise capacity in healthy subjects.

Adaptation, Physiological↗
PubMed2002

Value of increase in bladder capacity in treatment of refractory monosymptomatic nocturnal enuresis in children.

OBJECTIVES: To evaluate children with refractory monosymptomatic nocturnal enuresis to determine whether detrusor overactivity (DOA) plays a role in 4 weeks of unsuccessful treatment with retention control training (RCT); whether an increase in bladder capacity can eventually be obtained by RCT plus oxybutynin; and whether the increase in capacity is the primary key to success. METHODS: Sixty-eight children with refractory monosymptomatic nocturnal enuresis were included. They all had a maximal cystometric capacity less than the age-expected value. RCT was done by water loading and retention to the point of urgency once daily. During training, changes in bladder capacity were evaluated by voiding charts. If after 4 weeks of RCT, less than a 10% increase in bladder capacity was noted, oral oxybutynin was added. RESULTS: The incidence of DOA was 66%. After 4 weeks of RCT, the bladder capacity increased in 20.6%. Combining RCT with oxybutynin led in the end to normalization of the bladder capacity in 79.4%. Older age and high-pressure DOA negatively influenced the ability to increase the bladder capacity. Fifteen children became completely dry, mainly by converting enuresis to nocturia. CONCLUSIONS: Unsuccessful RCT is often caused by DOA, especially if a bladder capacity rise of at least 10% cannot be achieved within 4 weeks. If oxybutynin is added to the treatment, normalization of bladder capacity can be obtained in most. This increased bladder capacity cures enuresis only in a minority by sharpening their arousal and provoking nocturia.

Administration, Oral↗
PubMed2005

[Selective cyclooxygenase-2 inhibitors. A population-based analysis of use in France over a three-year period and comparison with randomised clinical trials].

OBJECTIVES: The use of selective cyclooxygenase-2 (COX-2) inhibitors is highly controversial today, mainly because of doubts about cardiovascular tolerance. Few studies have assessed the use of these drugs in daily clinical practice. This study aims to assess the changes in their use in daily practice in France and to compare it with their use in randomized clinical trials. METHODS: The French National Health Insurance Fund AMPI database of self-employed workers in non-agricultural occupations was used to obtain the following information: patients requesting reimbursement for celecoxib and rofecoxib between November 2000 and October 2003, morbidity assessed by enrollment on the lists of chronic diseases for which care is fully (100%) reimbursed, pregnancy (assessed by the payment of physicians' or hospital fees for delivery or by maternity benefits), and concomitant drugs (by claims for reimbursement). We compared these patients with those in randomized clinical trials (RCT) of celecoxib or rofecoxib published in either English or French before November 2003; we focused on their demographic characteristics, morbidity, pregnancy and concomitant drug use. RESULTS: Use of COX-2 inhibitors in France did not vary over the study period, except for patients' mean age (range: 64.2-62.9 years), proportion of women (56.7%-54.7%) and use of gastroprotective drugs (18.2%-28.4%). The mean age of patients in our study was 10 years older than that of RCT patients, and the proportion of women in our study was 15% lower. The percentage of women who took these drugs while pregnant was 0.02% in our study and 0.09% in the RCT. The percentage of patients with long-term chronic disorders overall was higher in our study than in the RCT, and the percentage for all specific long-term diseases except rheumatoid arthritis was also higher (for example, more patients had cardiovascular diseases or diabetes in our study [15%] than in the RCT [6%]). Patients in our study also used concomitant drugs from 9 of the 14 principal Anatomical Therapeutic Chemical classification groups more frequently than RCT patients: for cardiovascular drugs, for example, the figures were 55% and 5%, respectively. CONCLUSION: The demographic characteristics, prevalence of chronic morbidity and use of concomitant drugs among COX-2 inhibitor users in France varied little over the three years after marketing approval. Compared with RCT patients, these users were less often female, were older and more often had cardiovascular diseases. Cardiovascular events occurring among COX-2 inhibitor users in France should be evaluated.

Adolescent↗
PubMed2001

The double-blind, randomized, placebo-controlled trial: gold standard or golden calf?

The double-blind randomized controlled trial (RCT) is accepted by medicine as objective scientific methodology that, when ideally performed, produces knowledge untainted by bias. The validity of the RCT rests not just on theoretical arguments, but also on the discrepancy between the RCT and less rigorous evidence (the difference is sometimes considered an objective measure of bias). A brief overview of historical and recent developments in "the discrepancy argument" is presented. The article then examines the possibility that some of this "deviation from truth" may be the result of artifacts introduced by the masked RCT itself. Can an "unbiased" method produce bias? Among the experiments examined are those that augment the methodological stringency of a normal RCT in order to render the experiment less susceptible to subversion by the mind. This methodology, a hypothetical "platinum" standard, can be used to judge the "gold" standard. The concealment in a placebo-controlled RCT seems capable of generating a "masking bias." Other potential biases, such as "investigator self-selection," "preference," and "consent" are also briefly discussed. Such potential distortions indicate that the double-blind RCT may not be objective in the realist sense, but rather is objective in a "softer" disciplinary sense. Some "facts" may not exist independent of the apparatus of their production.

Bias↗