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Psychotherapy of childhood anxiety disorders: A meta-analysis.

BACKGROUND: The present study compared the efficacy of psychotherapy for childhood anxiety disorders (excluding trials solely treating post-traumatic stress disorder or obsessive-compulsive disorder). METHODS: The meta-analysis included studies that met the basic CONSORT (consolidated standards of reporting trials) criteria. Several outcome variables (e.g. effect sizes, percentage of recovery) were analyzed using completer and intent-to-treat analyses during post-treatment and follow-up assessment. Twenty-four studies published by March 2005 were included in this meta-analysis. RESULTS: In all the included studies, the active treatment condition was cognitive-behavioral. The overall mean effect of treatment was 0.86. No differences in outcome were found between individual and group treatments or child- and family-focused treatments. Follow-up data demonstrated that treatment gains were maintained up to several years after treatment. CONCLUSIONS: These findings provide evidence that anxiety disorders in children can be treated efficaciously. The gathered data support the clinical utility of cognitive-behavioral therapy in this regard. Randomized controlled trial studies investigating treatments other than cognitive-behavioral therapy are missing.

Anxiety Disorders↗

Effect of integrated traditional Chinese and Western medicine on SARS: a review of clinical evidence.

AIM: To assess the possible effect of integrated traditional Chinese and Western medicine on severe acute respiratory syndromes. METHODS: The current available randomized controlled trials of integrated traditional Chinese and Western medicine on SARS were identified through systematically searching literature in any languages or any types of publications. Additional studies of gray literature were also collected. The quality of studies was evaluated by two investigators independently based largely on the quality criteria specified CONSORT. Statistical analysis of the results was performed using RevMan 4.2.0 software developed by the Cochrane Collaboration. RESULTS: Six studies (n = 366) fulfilling the inclusion criteria were found, of which the quality of one study was graded as B, the remaining five were graded as C. Two studies were performed with meta-analysis, the other four studies existed some heterogeneity for which meta-analysis could not be performed, a significant effect on lung infiltrate absorption was found in the treatment groups of these two studies (RR 6.68, 95% CI (2.93, 15.24), P<0.01), there was no significant differences between the mortality (RR 0.86, 95% CI (0.22, 3.29), P = 0.82) and the average dosage of corticosteroid (WMD -39.65, 95% CI (-116.84, 37.54), P = 0.31). The other three studies also showed significant differences in infiltrate absorption, including national drug No. 2. 3. 4 in combination with Western medicine (RR 5.45, 95% CI (1.54, 19.26)), compound formulas NO. 1 combined with Western medicine (WMD 0.24, 95% CI (0.02, 0.46)), compound formulas combined with Western medicine (RR 8.06, 95% CI (0.40, 163.21)). Kangfeidian No.4 in combination with Western medicine had no significant effect on symptom improvement such as loss of dyspnea and cough (RR 1.50, 95%CI (0.41, 5.43)) and (RR 1.29, 95%CI (0.30, 5.43)). CONCLUSION: Integrated traditional Chinese and Western medicines has some positive effects on lung infiltrate absorption in SARS patients, and is recommended as an adjunct treatment for SARS. However, its effect on SARS requires further careful study due to limited available randomized control trials.

Antiviral Agents↗

How well are randomized controlled trials reported in the dermatology literature?

OBJECTIVE: To assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal. DESIGN AND DATA SOURCES: In a survey of all published parallel group randomized controlled trials, we found 73 reports with allocation described as randomized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997. MAIN OUTCOME MEASURES: Direct and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis. RESULTS: Hand searching identified 73 randomized controlled trials, but only 31 of these were found by searching MEDLINE for the publication type clinical trials. Of the 73 randomized controlled trials, 68 contained sufficient information to include in the analysis. Only 1 study (1%) reported the method of random sequence generation, and only 5 studies (7%) reported adequate concealment of allocation. Among 38 trials that used simple randomization, the sample sizes in the comparison groups were identical in 22 occasions, raising the possibility that simple randomization might not have been adequately generated or concealed. Most trials (88%) excluded some randomized participants from their analysis. The median sample size was 23 per trial. Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis. CONCLUSIONS: Hand searching is important for locating all relevant trials. There is the need for higher methodological quality in clinical trial reporting in dermatology journals. The adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.

Data Collection↗

Post-conception mating in wild long-tailed macaques (Macaca fascicularis): characterization, endocrine correlates and functional significance.

In many anthropoid primates, mating activity is not restricted to the ovarian cycle but also occurs during pregnancy. Although it has been suggested that the main function of this post-conception mating is to confuse paternity, studies showing whether or not male primates can distinguish between the fertile phase of the conception cycle (FPCC) and the period of peak post-conception mating (peak PCM) are almost non-existent. Here, we examine whether the pattern of female sexual traits (specific sexual behaviors, sexual swelling) and female attractiveness to males differ between FPCC and peak PCM in 6 wild female long-tailed macaques. We also use fecal hormone analysis to investigate whether female traits during peak PCM are related to changes in female sex hormones. All females exhibited a distinct period of heightened mating activity around days 45-60 of gestation. During peak PCM, swelling size and frequency of female solicitations (but not reaching back) were significantly correlated with changes in the estrogen to progestogen ratio. Swelling size, frequency of female sexual behaviors and copulations and proportion of male-initiated copulations and ejaculations were not significantly different between FPCC and peak PCM. Although males spent significantly less time consorting females during peak PCM, all (particularly low-ranking and non-resident males) invested heavily in terms of reproductive costs associated with mate-guarding and mating during pregnancy. We conclude that post-conception mating in wild long-tailed macaques is not merely a by-product of endocrine changes and devoid of adaptive function. Our results more strongly support the hypothesis that it may form part of a female reproductive strategy to confuse paternity, which appears to apply particularly to low-ranking and extra-group males.

Animals↗

Human lymphocyte subpopulations identified by using three-color immunofluorescence and flow cytometry analysis: correlation of Leu-2, Leu-3, Leu-7, Leu-8, and Leu-11 cell surface antigen expression.

Three-color immunofluorescence has been used to determine the co-expression of cell surface antigens on human peripheral blood lymphocytes. Monoclonal antibodies or avidin were coupled to either FITC (green), phycoerythrin (orange), or Texas Red (red) fluorochromes. These three fluorochromes could be independently measured by using a dual laser FACS IV system equipped with an argon ion laser (488 nm) and a dye laser (600 nm). Human peripheral blood lymphocytes were stained with the following combinations of reagents: (1) FITC anti-Leu-11a + PE anti-Leu-2a + TR avidin/biotin anti-Leu-7; (2) FITC anti-Leu-11a + PE anti-Leu-3a + TR avidin/biotin anti-Leu-7; (3) FITC anti-Leu-8 + PE anti-Leu-2a + TR avidin/biotin anti-Leu-7; and (4) FITC anti-Leu-11a + PE anti-Leu-2 + TR avidin/biotin anti-Leu-8. The light scatter, green fluorescence, orange fluorescence, and red fluorescence signals for each sample were stored by a Consort 40 PDP/11 computer in list mode files. Sequential reanalysis of the data directly demonstrated the existence of several unrecognized subpopulations of lymphocytes. Previously, we reported that the anti-Leu-7 and anti-Leu-11 antibodies can be used to identify discrete subsets of human NK cells with distinct functional capacities. In this report, we show that these subsets can be further subdivided on the basis of Leu-8 and Leu-2 expression. Thus, these studies illustrate how multicolor and multiparameter flow cytometry can further our understanding of cellular heterogeneity within this group of lymphocytes.

Adult↗

Infection of a nonspecific urethritis patient and his consort with a pathogenic species of nonspecific urethritis Corynebacteria, Corynebacterium genitalium, N. SP.

A patient with nonspecific urethritis (NSU) and his consort were examined for infection with NSU corynebacteria, mycoplasmas, and gonococci. No classic and T-mycoplasmas or gonococci were cultured, but one species of NSU corynebacteria was isolated not only from the patient's urethral discharge during three episodes of NSU but also from his consort. It was not isolated after successful treatment of the patient with tetracycline and the use of condoms prevented reoccurrence of urethritis. This NSU corynebacterium was isolated previously from one epididymitis patient and two NSU patients but not from any of the normal male and female subjects examined. Therefore, this strain is considered to be one of the etiologic agents of NSU and female subjects are asymptomatic carriers. In consequence, it is suggested that NSU corynebacteria which are commensals and pathogens of the male and female urogenital tracts should be incorporated in a new species, of the Coryneform group, and that this strain should be the type species, Corynebacterium genitalium n. sp.

Adult↗

Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement.

Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials. We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs.

Behavioral Research↗

Proximate mechanisms of reproductive monopolization in male moustached tamarins (Saguinus mystax).

In moustached tamarin (Saguinus mystax) groups, the single breeding female mates polyandrously with most or all nonrelated adult males. Nonetheless, paternity is monopolized in many groups by a single male. No evidence for male endocrine suppression has been found in this species. The proximate mechanisms of monopolization thus remain poorly understood. The aim of this study was to investigate the possible impact of agonistic interactions and mate-guarding on the monopolization of paternity in male moustached tamarins. Furthermore, we evaluated the likely costs of these behaviors, and whether olfactory cues might be used for its timing. We used behavioral data on proximity, agonistic interactions, time budgets, and scent-marking behavior to answer these questions. While direct agonistic competition does not play a prominent role, fertile females were consorted in some periods by one male, the sire of the previous and next litter. Consorting was instigated nearly exclusively by the male. It probably occurred during the female's periods of highest fertility, and thus likely functions as mate-guarding. The timing of the consortship was probably guided by olfactory cues in the female's scent marks. While we did not obtain direct evidence for energy costs in terms of increased energy expenditure or decreased food intake, we found that consorting males are more conspicuous and therefore may be more vulnerable to predators.

Agonistic Behavior↗

Population-based assessment of surgical treatment trends for patients with melanoma in the era of sentinel lymph node biopsy.

PURPOSE: The surgical staging of melanoma dramatically changed with the introduction of sentinel lymph node (SLN) biopsy. In this study, Surveillance, Epidemiology, and End Results (SEER) data were examined to determine how surgical treatment is being carried out and whether SLN biopsy is being performed in melanoma patients in conformance with National Comprehensive Cancer Network (NCCN) guidelines. PATIENTS AND METHODS: The SEER database (1998 to 2001) was searched for all patients with invasive melanoma. NCCN guidelines were used to define optimal stage-specific surgical treatment. Treatment trends in patients with stages I to III disease were summarized, and multivariate analyses were performed to identify factors associated with nonadherence with treatment guidelines. RESULTS: A total of 21,867 melanoma patients were identified; 18,499 of these patients met the inclusion criteria. The number of patients diagnosed with stage III melanoma increased by 55.7% over the study period, and this corresponded to a 53% increase in the number of SLN biopsies performed annually. The odds ratios for nonadherence were 2.32, 2.27, and 1.54 for stages IB, II, and III disease, respectively, compared with stage IA melanoma. Multivariate analyses revealed that age more than 65 years, marital status, minority populations, and primary tumor location were associated with nonadherence with guidelines. Treatment patterns among tumor registries also varied significantly. CONCLUSION: Stage migration is evident in the SEER registries in consort with increasing use of SLN biopsy. Although treatment trends are improving, SLN biopsy continues to be underused, particularly in the elderly and minority populations, in patients with truncal and head/neck melanomas, and also in some geographic regions of the United States.

Adult↗

[The evaluation of the quality of clinical trials: the rationale, usefulness and drawbacks].

The quality of a randomised controlled trial should be understood as its internal validity, that is, the extent in which the study conclusions show correctly what actually happened in the design and conduct phases. This validity may be compromised by multiple biases coming from the allocation of subjects to study groups, treatment administration, observation of outcome variables, patient follow-up and statistical analysis. The presence of bias is assessed through three kinds of measurements: individual components, checklists and numerical scales. In systematic reviews some kind of quality assessment is necessary, which evaluates the quality of individual trials by means of several methods: a) a threshold that sets the minimal level of quality required; b) the relationship between quality and variability in trial results; c) sensitivity analysis, and d) quality scores as weights of trials. However, there exists considerable discrepancy among the published scales whereas their usefulness to assess the quality of trials to be included in the systematic review is a matter of controversy. We hope that the Consolidated Standards of Reporting Trials (CONSORT) initiative to standardize the report of randomized controlled trials and other proposals will contribute to obtain a more realistic view for each trial and to improve their internal validity.

Humans↗

CSF 5-HIAA, testosterone, and sociosexual behaviors in free-ranging male rhesus macaques in the mating season.

This study examines sexual behavior, serotonin turnover in the central nervous system, and testosterone in free-ranging non-human primates. Study subjects were 33 young adult male rhesus macaques (Macaca mulatta) living in naturalistic social groups on a 475-acre South Carolina barrier island. Blood and cerebrospinal fluid (CSF) samples were obtained during random trappings, and the subjects were located for observation by radio telemetry. Quantitative behavioral samples totaling 203 observation hours were taken during two mating seasons (September through January) in 1994 and 1995. Control observations (65 h) on 13 subjects were also taken during the non-mating seasons in 1994 and 1995. The results indicate that CSF 5-hydroxyindoleacetic acid (5-HIAA), CSF testosterone, and plasma testosterone concentrations increase significantly during the mating season. During the mating season, there were significant increases in high intensity aggression, low intensity aggression, grooming behavior, and heterosexual mounting. In the mating season, CSF 5-HIAA was significantly correlated with several sociosexual behaviors: consorts per hour, heterosexual mounts per hour, and inseminations per hour. In contrast to previous findings from the non-mating season, CSF 5-HIAA was not correlated with any measures of aggression or sociality, although during consorting, CSF 5-HIAA was positively correlated with grooming. From these findings, we conclude that the lack of correlation between intense and severe aggression and CSF 5-HIAA in the mating season may reflect the use of high intensity aggression in 'normative' male-male competition over access to reproductively active females. We also conclude that CNS serotonin turnover is positively correlated with sexual competence, i.e. males with low CSF 5-HIAA concentrations are less sexually competent than males with higher concentrations.

Aggression↗

Interventions for replacing missing teeth: preprosthetic surgery versus dental implants.

BACKGROUND: Preprosthetic surgery refers to the surgical procedures that can modify the oral anatomy to facilitate the retention of conventional dentures. Osseointegrated implants offer an alternative treatment to improve denture retention. A denture may be connected by special attachments to implants placed into the jaw. OBJECTIVES: To test the null hypothesis of no difference in the success (patient satisfaction and morbidity) and cost effectiveness between conventional prostheses that require preprosthetic surgery (PPS) and implant retained prostheses (IRO) that do not require preprosthetic surgery, against the alternative hypothesis of a difference. SEARCH STRATEGY: The Cochrane Oral Health Group (OHG) Specialised Register (May 2002), the Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE and EMBASE (May 2002) were searched. In addition, 55 implant companies were contacted and the bibliographies of review articles were checked for studies outside the hand searched journals and personal references were searched. SELECTION CRITERIA: Randomised controlled trials comparing preprosthetic surgery and implant retained dentures for improving denture retention. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two reviewers (HW, PC). Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out (ME, PC). The Cochrane OHG's statistical guidelines were followed. MAIN RESULTS: One study, containing 60 participants, reported in four articles was identified for inclusion in this review. No studies were excluded. There was a statistically significant difference between mean patient satisfaction scores with patients in the IRO group being more satisfied in general at both year one (WMD = -0.66(95% CI; -1.28 to -0.04)) and five years (WMD = -0.90(95%CI; -1.74 to -0.06). Altered sensation of the lower lip and chin was measured at one year and five years. There was no statistically significant difference at either time point and no patients had altered sensation at five years. REVIEWER'S CONCLUSIONS: There is weak evidence from the results of one randomised controlled trial including 60 subjects that patients are generally less satisfied with preprosthetic surgery and a conventional denture than with an implant retained denture. There is a need for more well designed trials comparing the success and cost-effectiveness of preprosthetic surgery and implant supported dentures. Such trials should be reported according to the CONSORT guidelines (http://www.consort-statement.org/). However, since preprosthetic surgery is considered to be an obsolete treatment nowadays, almost completely replaced by dental implants, it may be that new RCTs on this topic will not be designed.

Dental Implantation↗

Research strategies for design and development of NSAIDs: clue to balance potency and toxicity of acetanilide compounds.

Despite the fact that many modern drug therapies are based on the concept of enzyme inhibition, inhibition of several enzymes leads to pathological disorders. Clinically used nonsteroidal anti-inflammatory drugs (NSAIDs) bind to the active site of the membrane protein, cyclooxygenase (COX) and inhibit the synthesis of prostaglandins, the mediators for causing inflammation. At the same time, inhibition of hepatic cysteine proteases by some NSAID metabolites like NAPQI is implicated in the pathogenesis of hepatotoxicity. As a part of our efforts to develop new effective NSAIDs, a comprehensive investigation starting from synthesis to the study of the final metabolism of acetanilide group of compound has been envisaged with appropriate feedback from kinetic studies to enhance our knowledge and technical competency to feed the know-how to the medicinal chemist to screen out and design new acetanilide derivatives of high potency and low toxicity. Structure-function relationship based on the interaction of acetanilide with its cognate enzyme, cyclooxygenase has been studied critically with adequate comparison with several other available crystal structures of COX-NSAID complexes. Furthermore, to make the receptor based drug design strategy a novel and comprehensive one, both the mechanism of metabolism of acetanilide and structural basis of inhibition of cysteine proteases by the reactive metabolite (NAPQI) formed by cytochrome P450 oxidation of acetanilide have been incorporated in the study. It is hoped that this synergistic approach and the results obtained from such consorted structural investigation at atomic level may guide to dictate synthetic modification with judicious balance between cyclooxygenase inhibition and hepatic cysteine protease inhibition to enhance the potential of such molecular medicine to relieve inflammation on one hand and low hepatic toxicity on the other.

Acetanilides↗

Interventions for replacing missing teeth: hyperbaric oxygen therapy for irradiated patients who require dental implants.

BACKGROUND: Dental implants offer one way to replace missing teeth and associated tissues. Patients who have undergone radiotherapy and those that have also undergone surgery for cancer may benefit particularly from reconstruction with implants. Hyperbaric oxygen therapy (HBO) has been advocated to improve the success of implant treatment in patients who have undergone radiotherapy but this remains a controversial issue. OBJECTIVES: This review aims to compare success, morbidity, patient satisfaction and cost effectiveness of dental implant treatment carried out with and without HBO in irradiated patients. SEARCH STRATEGY: The Cochrane Oral Health Group Specialised Register, the Cochrane Controlled Trials Register, MEDLINE and EMBASE were searched. In addition, the bibliographies of review articles were checked for studies outside the handsearched journals and personal references were searched. We also wrote to implant manufacturers and experts in the field. SELECTION CRITERIA: Randomised controlled trials of HBO therapy for irradiated patients requiring dental implants. DATA COLLECTION AND ANALYSIS: No randomised trials were identified. MAIN RESULTS: No data were available. REVIEWER'S CONCLUSIONS: Clinicians ought to make patients aware of the lack of reliable clinical evidence for or against the clinical effectiveness of HBO in irradiated patients requiring dental implants. There is a definite need for RCTs to ascertain the effectiveness of HBO in irradiated patients requiring dental implants. These trials ought to be of a high quality and reported as recommended by the CONSORT statement (http://www.consort-statement.org/). Each clinical centre may have limited numbers of patients and it is likely that trials will need to be multi-centred.

Dental Implants↗

Interventions for replacing missing teeth: different times for loading dental implants.

BACKGROUND: To minimize the risk of implant failure, osseointegrated oral implants are conventionally kept load-free during the healing period. During healing removable prostheses are used, however many patients find these temporary prostheses rather uncomfortable and it would be beneficial if the healing period could be shortened without jeopardizing implant success. Nowadays immediate and early loaded implants are commonly used in mandibles of good bone quality. It would be useful to know whether there is a difference in success rates between immediately or early loaded implants compared with conventionally loaded implants. OBJECTIVES: To test the null hypothesis of no difference in the clinical performance between osseointegrated implants loaded at different times 1 year after loading. SEARCH STRATEGY: The Cochrane Oral Health Group's Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE were searched. Handsearching included several dental journals. Authors of all identified trials, an internet discussion group and 55 oral implant manufacturers were contacted to find unpublished randomized controlled trials (RCTs). The last electronic search was conducted on 2 February 2004. SELECTION CRITERIA: All RCTs of root-form osseointegrated oral implants having a follow up of at least 1 year comparing the same osseointegrated root-form oral implants loaded at different times. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two reviewers. Authors were contacted for details of randomization and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed. MAIN RESULTS: Seven RCTs were identified and five trials including 124 patients in total were suitable for inclusion. Implants have been either immediately loaded after insertion (2 to 3 days), early loaded (6 weeks) or conventionally loaded (3 to 8 months) in edentulous mandibles of adequate bone quality and shape. On a patient, rather than per implant basis, there were no statistically significant differences for prosthesis failures, implant failures and marginal bone loss on intra-oral radiographs. REVIEWERS' CONCLUSIONS: While it is possible to successfully load oral implants immediately after their placement in mandibles of adequate bone density and height of carefully selected patients, it is yet unknown how predictable this approach is. More well designed RCTs are needed to understand how predictable immediate and early loading are. Such trials should be simply designed and should be reported according to the CONSORT guidelines (http://www.consort-statement.org/). It is suggested that priority should be given to trials assessing the effectiveness of immediately loaded implants rather than early loaded ones.

Bone Density↗

Interventions for replacing missing teeth: different times for loading dental implants.

BACKGROUND: To minimize the risk of implant failure, osseointegrated oral implants are conventionally kept load-free during the healing period. During healing removable prostheses are used, however many patients find these temporary prostheses rather uncomfortable and it would be beneficial if the healing period could be shortened without jeopardizing implant success. Nowadays immediate and early loaded implants are commonly used in mandibles of good bone quality. It would be useful to know whether there is a difference in success rates between immediately or early loaded implants compared with conventionally loaded implants. OBJECTIVES: To test the null hypothesis of no difference in the clinical performance between osseointegrated implants loaded at different times one year after loading. SEARCH STRATEGY: The Cochrane Oral Health Group Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE were searched. Handsearching included several dental journals. Authors of all identified trials and 55 oral implant manufacturers were contacted to find unpublished RCTs. The last electronic search was conducted on 8 May 2002. SELECTION CRITERIA: All RCTs of root-form osseointegrated oral implants having a follow-up of one year comparing the same osseointegrated root-form oral implants loaded at different times. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two reviewers. Authors were contacted for details of randomization and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed. MAIN RESULTS: Only three RCTs were identified and two trials including 68 patients in total were suitable for inclusion in this review. Implants have been either immediately loaded after insertion (two to three days), early loaded (six weeks) or conventionally loaded (three to eight months) in edentulous mandibles of adequate bone quality and shape. On a patient, rather than per implant basis, there were no statistically significant differences for prosthesis failures, implant failures and marginal bone loss on intra-oral radiographs. REVIEWER'S CONCLUSIONS: While it is possible to successfully load oral implants immediately after their placement in mandibles of adequate bone density and height of carefully selected patients, it is yet unknown how predictable this approach is. More well designed RCTs are needed to understand how predictable immediate and early loading are. Such trials should be simply designed and should be reported according to the CONSORT guidelines (http://www.consort-statement.org/). It is suggested that priority should be given to trials assessing the effectiveness of immediately loaded implants rather than early loaded ones.

Bone Density↗

Intravascular and extravascular pulmonary fluid volumes during chronic experimental left ventricular dysfunction.

To assess the effects of chronic left ventricular (LV) dysfunction on intravascular pulmonary blood volume (PBV) and extravascular lung water (EVLW) lung fluid volumes, 56 dogs were evaluated by means of double-indicator dilution techniques. PBV and EVLW were measured in seven control dogs, in eight dogs 4 hours after the production of left heart dysfunction, and then in three additional groups of dogs (n = seven in each group) 7, 14, and 30 days after the production of LV dysfunction. Twenty dogs were excluded because we were unable to produce elevations in LV end-diastolic volume greater than 25 mm Hg. EVLW was measured using heat as the diffusible indicator, and electric shock was used to create heart block and myocardial scarring in order to produce LV dysfunction. Plasma volume was calculated prior to death by means of radioiodinated albumin. In the remaining animals, electric shock acutely and chronically elevated LV end-diastolic pressure (control 2.3 +/- 1.0 mm Hg; postshock pressures greater than 25 mm Hg). PBV increased initially after cardiac failure and remained so as time progressed, although it represented a smaller fraction of the plasma volume as time passed (11.2 +/- 2.1% control, 15.9 +/- 3.4% at 4 hours after failure, and 12.6 +/- 2.0% at 7 days; the former p less than 0.005 vs control, the latter p less than 0.01 vs control). EVLW increased as time progressed, in consort with small but progressive increases in left atrial pressure. Thus, we conclude that the effects of acute and chronic LV dysfunction on pulmonary circulation are significantly different.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

REporting recommendations for tumour MARKer prognostic studies (REMARK).

Despite years of research and hundreds of reports on tumour markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many tumour marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalisability of the study results. The development of guidelines for the reporting of tumour marker studies was a major recommendation of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. Similar to the successful CONSORT initiative for randomised trials and the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

Biomarkers, Tumor↗