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PubMed1988

Subclinical penile human papillomavirus infection and dysplasia in consorts of women with cervical neoplasia.

Fifty men whose sexual partners were 50 women with histologically proved cervical intraepithelial neoplasia (CIN) grade III (severe dysplasia or carcinoma in situ) were studied. A further 25 men whose current regular sexual partners were 25 women with chlamydial cervicitis were recruited as controls. If either of the partners in either group had genital condylomata acuminata or a known history of similar lesions, the couple was excluded from the study. Abnormal penile epithelium, which was detected by colposcopy after application of 5% acetic acid to the penile skin, was reported in 25 men in the study group compared with three in the control group. Histologically proved subclinical penile infection with human papillomavirus (HPV) was present in 23 men in the study group compared with three in the control group (p less than 0.01). Of the 50 men in the study group, four had histologically proved severe penile dysplasia or carcinoma in situ with evidence of HPV infection, the disease being subclinical in each case and diagnosed on histology of a specimen obtained by colposcopically directed biopsy. HPV DNA was detected on filter hybridisation of penile scrapes from 15 of the 23 men in the study group with histologically proved penile HPV infection, HPV16 DNA being detected in 10 of them. HPV DNA was detected on DNA-DNA hybridisation of biopsy material in seven of 18 men with histologically proved penile HPV infection. Five of these biopsy specimens were positive for HPV16 DNA. Only one man in the control group had HPV DNA detected in a penile scrape. This patient had histologically proved subclinical penile HPV infection. Such lesions may represent an important male reservoir of HPV types implicated in genital squamous carcinogenesis in both sexes.

Adult↗
PubMed2001

Specificity versus variability: effects of practice conditions on the use of afferent information for manual aiming.

Although proponents of the motor schema theory hold that a decrease in the reliance on afferent information will occur with practice in consort with the development of motor programs, supporters of the specificity of practice by hypothesis suggest that a performer's reliance on the available sources of afferent information during acquisition increases with the amount of practice. To reconcile these competing positions, four groups of 9 participants aimed to targets under either a constant or a variable practice schedule, with or without vision of the effector. After modest (15 trials) and moderate (150 trials) practice, participants were tested in both their own and in the alternate vision condition. Results indicate that the utilization of online kinesthetic information was enhanced through practice regardless of the availability of vision during acquisition. This was especially true for the groups practicing under a variable practice schedule

Adolescent↗
PubMed2002

Interventions for replacing missing teeth: different types of dental implants.

BACKGROUND: Dental implants are available in different materials, shapes and with different surface characteristics. In particular, numerous implant surface modifications have been developed for enhancing clinical performances. OBJECTIVES: To test the null hypothesis of no difference in clinical performance between various root-formed osseointegrated implant types. SEARCH STRATEGY: The Cochrane Oral Health Group Specialised Trials Register, The Cochrane Controlled Trials Register, MEDLINE and EMBASE were searched. Hand searching included several dental journals. Bibliographies of relevant clinical trials and review articles were checked for studies outside the handsearched journals. In addition, authors of all identified trials and fifty-five oral implant manufacturers were contacted to find unpublished or ongoing RCTs. Two extensive personal libraries (ME and AJ) were consulted. The last electronic search was conducted 8th May 2002. SELECTION CRITERIA: All randomised controlled trials of oral implants comparing implants with different materials, shapes and surface properties having a follow-up of at least one year. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two reviewers (ME & HW). Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed. MAIN RESULTS: Thirty publications, representing 13 different RCTs, were identified. Five of these RCTs (seven publications), which reported results from a total of 326 patients, were suitable for inclusion in the review. Six implant systems were compared: Astra, Branemark, IMZ, ITI, Steri-Oss and Southern with a follow-up ranging from one to three years. All implants were made in commercially pure titanium and had different shapes and surface preparations. On a patient rather than per implant basis there were no statistically significant differences for failures and marginal bone level changes on intra-oral radiographs between various implant systems. REVIEWER'S CONCLUSIONS: There was no evidence that any of the implant systems evaluated was superior to the other. However, these findings are based on a few RCTs all having short follow-up periods and few participants. More RCTs should be conducted, with follow-up of at least five years and including a sufficient number of patients, to detect a true difference if any exists. Such trials should be reported according to the CONSORT guidelines (http://www.consort-statement.org/).

Dental Implantation, Endosseous↗
PubMed2006

Massage for mechanical neck disorders.

BACKGROUND: Mechanical neck disorders (MND) are common, disabling and costly. Massage is a commonly used modality for the treatment of neck pain. OBJECTIVES: To assess the effects of massage on pain, function, patient satisfaction and cost of care in adults with neck pain. To document adverse effects of treatment. SEARCH STRATEGY: Cochrane CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL databases were electronically searched, without language restriction, from their inception to September 2004 SELECTION CRITERIA: Studies using random or quasi-random assignment were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently conducted citation identification, study selection, data abstraction and methodological quality assessment. Using a random-effects model, we calculated the relative risk and standardized mean difference. MAIN RESULTS: Nineteen trials met the inclusion criteria. Overall, the methodological quality was low, with 12/19 assessed as low-quality studies. Trials could not be statistically pooled because of heterogeneity in treatment and control groups. Therefore, a levels-of-evidence approach was used to synthesize results. Assessment of the clinical applicability of the trials showed that the participant characteristics were well reported, but neither the descriptions of the massage intervention nor the credentials or experience of the massage professionals were well reported. Six trials examined massage as a stand-alone treatment. The results were inconsistent. Of the 14 trials that used massage as part of a multimodal intervention, none were designed such that the relative contribution of massage could be ascertained. Therefore, the role of massage in multimodal treatments remains unclear. AUTHORS' CONCLUSIONS: No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain. Pilot studies are needed to characterize massage treatment (frequency, duration, number of sessions, and massage technique) and establish the optimal treatment to be used in subsequent larger trials that examine the effect of massage as either a stand-alone treatment or part of a multimodal intervention. For multimodal interventions, factorial designs are needed to determine the relative contribution of massage. Future reports of trials should improve reporting of the concealment of allocation, blinding of outcome assessor, adverse events and massage characteristics. Standards of reporting for massage interventions, similar to CONSORT, are needed. Both short- and long-term follow-up are needed.

Humans↗
PubMed2004

Antibiotic prophylaxis for operative vaginal delivery.

BACKGROUND: Vacuum and forceps assisted vaginal deliveries are reported to increase the incidence of postpartum infections and maternal readmission to hospital compared to spontaneous vaginal delivery. Prophylactic antibiotics are prescribed to prevent these infections. However, the benefit of antibiotic prophylaxis for operative vaginal deliveries is still unclear. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis in reducing infectious puerperal morbidities in women undergoing operative vaginal deliveries including vacuum and/or forceps deliveries. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (November 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003) and MEDLINE (1966 to November 2003). SELECTION CRITERIA: All randomised trials comparing any prophylactic antibiotic regimens with placebo or no treatment in women undergoing vacuum or forceps deliveries were eligible. Participants were all pregnant women without evidence of infections or other indications for antibiotics of any gestational age undergoing vacuum or forceps delivery for any indications. Interventions were any antibiotic prophylaxis (any dosage regimen, any route of administration or at any time during delivery or the puerperium) compared with either placebo or no treatment. DATA COLLECTION AND ANALYSIS: Four reviewers assessed trial eligibility and methodological quality. Two reviewers extracted the data independently using prepared data extraction forms. Any discrepancies were resolved by discussion and a consensus reached through discussion with all reviewers. We assessed methodological quality of the included trial using the standard Cochrane criteria and the CONSORT statement of randomised controlled trials. We calculated the relative risks using a fixed effect model and all the reviewers interpreted and discussed the results. MAIN RESULTS: One trial, involving 393 women undergoing either vacuum or forceps deliveries, was included. This trial identified only two out of the nine outcomes specified in this review. It reported seven women with endomyometritis in the group given no antibiotic and none in prophylactic antibiotic group. This difference did not reach statistical significance, but the relative risk reduction was 93% (relative risks 0.07; 95% confidence interval (CI) 0.00 to 1.21). There was no difference in the length of hospital stay between the two groups (weighted mean difference 0.09 days; 95% CI -0.23 to 0.41). REVIEWERS' CONCLUSIONS: The data were too few and of insufficient quality to make any recommendations for practice. Future research on antibiotic prophylaxis for operative vaginal delivery is needed to conclude whether it is useful for reducing postpartum morbidity.

Antibiotic Prophylaxis↗
PubMed1989

Characterization of selected gram-negative oral microorganisms by SDS-PAGE.

SDS-PAGE analysis of bacterial cell proteins was used to examine a diverse group of oral microorganisms. Most of the species examined, including physiologically similar microorganisms, produced distinct protein patterns which are characterized by the distribution of their major protein bands. The SDS-PAGE system described provides a rapid, simple and standardized identification technique to be used in consort with routine taxonomic procedures.

Bacterial Proteins↗
PubMed2005

[Diagnostic (STARD) and prognostic (REMARK) studies].

Deficiencies in how research studies are reported are both well-documented and widespread across all medical specialties and study designs. Although randomised trials have received the most attention in this regard, similar concerns have been expressed about reporting of other types of research including diagnostic and epidemiological studies. If a journal article describes in enough detail what was done at each stage of a study, readers will have enough information to allow them to decide on the merits of the results for themselves. From this simple idea comes the scientific rationale of developing guidelines on how to report research. Recommended processes to produce reporting guidelines have evolved over several years during the preparation of a sequence of reporting guidelines starting with CONSORT and QUOROM in the 1990s. We describe initiatives to develop reporting guidelines for diagnostic accuracy studies (STARD) and tumour marker prognostic studies (REMARK).

Biomarkers, Tumor↗
PubMed2001

Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations.

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗
PubMed2002

Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture.

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journal editors are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗
PubMed2006

Evidence of improving quality of reporting of randomized controlled trials in subfertility.

BACKGROUND: The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews. METHODS: A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included. RESULTS: One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome 'live birth'. CONCLUSIONS: Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library.

Female↗
PubMed1989

Treatment of sexual contacts of syphilitic pregnant women.

Between August 1984 and May 1985, 197 syphilitic pregnant women were diagnosed at the antenatal clinic, Department of Obstetrics & Gynaecology, Faculty of Medicine, Chulalongkorn University. One hundred and sixty-nine male sexual contacts were serologically tested for syphilis and seventy-eight cases were found positive. Twenty-eight cases refused to be tested. Thirty-two syphilitic male contacts had cerebrospinal fluid tests and four were found to be abnormal. Fifty-three cases or 67.9 per cent of 78 syphilitic male consorts did not complete a full diagnostic and treatment protocol. They preferred to be treated with benzathine penicillin G 2.4 million units intramuscularly for 3 consecutive weeks. After this treatment no patient agreed to a repeat spinal tap. This behavioral attitude concurred with their socioeconomic background. All were from a low socioeconomic group and lacked health knowledge. This made it difficult to work with them and contributed to inadequate management of their disease.

Adult↗
PubMed2006

Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance.

BACKGROUND: The interpretation of the results of active-control trials regarding the efficacy and safety of a new drug is important for drug registration and following clinical use. It has been suggested that non-inferiority and equivalence studies are not reported with the same quantitative rigor as superiority studies. METHODS: Standard methodological criteria for non-inferiority and equivalence trials including design, analysis and interpretation issues were applied to 18 recently conducted large non-inferiority (15) and equivalence (3) randomized trials in the field of AIDS antiretroviral therapy. We used the continuity-corrected non-inferiority chi-square to test 95% confidence interval treatment difference against the predefined non-inferiority margin. RESULTS: The pre-specified non-inferiority margin ranged from 10% to 15%. Only 4 studies provided justification for their choice. 39% of the studies (7/18) reported only intent-to-treat (ITT) analysis for the primary endpoint. When on-treatment (OT) and ITT statistical analyses were provided, ITT was favoured over OT for results interpretation for all but one study, inappropriately in this statistical context. All but two of the studies concluded there was "similar" efficacy of the experimental group. However, 9/18 had inconclusive results for non-inferiority. CONCLUSION: Conclusions about non-inferiority should be drawn on the basis of the confidence interval analysis of an appropriate primary endpoint, using the predefined criteria for non-inferiority, in both OT and ITT, in compliance with the non-inferiority and equivalence CONSORT statement. We suggest that the use of the non-inferiority chi-square test may provide additional useful information.

Acquired Immunodeficiency Syndrome↗
PubMed2001

Complex social structure, alliance stability and mating access in a bottlenose dolphin 'super-alliance'.

Large brain size in mammals has been related to the number and complexity of social relationships, particularly social alliances within groups. The largest within-group male alliance known outside of humans is found in a social network (> 400) of Indian Ocean bottlenose dolphins (Tursiops aduncus) in Shark Bay Western Australia. Members of this dolphin 'super-alliance' cooperate against other alliances over access to females. Males within the super-alliance form temporary trios and occasionally pairs in order to consort with individual females. The frequent switching of alliance partners suggests that social relationships among males within the super-alliance might be relatively simple and based on an equivalence rule', thereby allowing dolphins to form large alliances without taxing their 'social intelligence'. The equivalence model predicts that the 14 males in the super-alliance should not exhibit differences in alliance stability or partner preferences. However, data from 100 consortships do not support the equivalence hypothesis. The 14 males exhibited striking differences in alliance stability and partner preferences suggesting that the super-alliance has a complex internal structure. Further, within the super-alliance, alliance stability correlates with consortship rate, suggesting that differentiated relationships within the super-alliance are based on competition for access to females.

Animals↗
PubMed1983

Influences of ovarian hormones on the food intake and feeding of captive and wild female chacma baboons (Papio ursinus).

The relationship between ovarian hormone changes and food intake was examined in three separate studies using captive intact, captive ovariectomized and wild intact chacma baboons (Papio ursinus). Measures of body weight, perineal turgescence and food intake all varied across the menstrual cycle for a group of seventeen intact laboratory housed females. Body weights showed steady increases up until the day of sex skin detumescence or breakdown. Perineal swell ratings also showed a constant rise ending with breakdown. Food intake, however, showed a pattern of decrease until three days preceding breakdown. Statistical analysis revealed a significant difference between food intake during the preovulatory and luteal period phases. Exogenous estradiol benzoate (EB) and progesterone treatments to a group of ten ovariectomized females demonstrated an inhibitory effect of EB upon food intake. No effects for progesterone were demonstrated. A field study of two wild troops confirmed a difference in percentage of time spent feeding for females in the fully swollen condition as contrasted to those whose perineums were flat. Data collected on fully swollen females suggested that consort relations had little effect upon the females' feeding time percentages.

Animals↗
PubMed2002

Variation in reproductive outcomes for captive male rhesus macaques (macaca mulatta) differing in CSF 5-hydroxyindoleacetic acid concentrations.

In rhesus macaque males, lower than average cerebrospinal fluid (CSF) concentrations of the principle metabolite of serotonin, 5-hydroxyindoleacetic acid (5-HIAA), have been linked to impulsivity, involvement in escalated aggression, failure to elicit consort relationships, production of fewer sperm plugs, and a relatively early age of mortality. Given these potential fitness costs, we performed two studies aimed at elucidating the effects of CSF 5-HIAA on reproduction. Study 1 retrospectively evaluated over a four-year period, the relative reproductive outcome for pairs of adult male rhesus macaques (n = 15) who lived in social groups and who differed in concentrations of CSF 5-HIAA. Study 2 examined the relationship between CSF 5-HIAA and sperm motility and density (n = 12), as a potential mechanism for maintaining variability in CSF 5-HIAA. For Study 1, an average measure from two CSF 5-HIAA samples was calculated for the two males who were present during the time when conception most likely took place (offspring birth date -165 +/- 14 days). Within-pair comparisons of CSF 5-HIAA concentrations between the sire and the non-successful male were drawn for each of the 72 offspring in the study. We found that while sires were typically the male with relatively higher CSF 5-HIAA within the pair, there were no absolute differences in CSF 5-HIAA between males who sired at least one offspring (sires) and those who failed to reproduce (non-sires). Furthermore, while absolute age was not predictive of reproductive outcome, sires with relatively high CSF 5-HIAA also tended to be also relatively older than their competitors. By contrast, for the males with relatively low CSF 5-HIAA who reproduced, sires were relatively younger than the non-sires. These differences in reproductive outcome for males differing in CSF 5-HIAA could not be explained by variability in sperm quantity or quality as we did not find evidence of a relationship between CSF 5-HIAA and either sperm measure. The results of this study suggest that as serotonergic function affects many aspects of behavior and survivorship, it might also be associated with reproductive outcome and different life-history strategies for males differing in concentrations of CSF 5-HIAA.

Animals↗
PubMed1985

Increased risk of cervical neoplasia in consorts of men with penile condylomata acuminata.

19 (76%) of 25 women who had been the sole sexual consorts, for at least 1 year, of men with pre-existing penile condylomata acuminata had similar lesions of the lower genital tract. 9 (36%) of the women had an abnormal cervix as judged by cytology, colposcopy, and histology, and 7 (77%) of these 9 had associated human papillomavirus (HPV) infection detected by DNA/DNA hybridisation. None of 20 women in an age-matched control group had cytological or colposcopic evidence of cervical epithelial atypia. It is suggested that penile HPV infection in a male partner places a woman at risk of cervical neoplasia.

Adult↗
PubMed1993

Chlamydia trachomatis in patients who used oral contraceptives and had intermenstrual spotting.

OBJECTIVE: To identify the incidence of positive assays for direct antigen detection of Chlamydia trachomatis in oral contraceptive (OC) users with and without intermenstrual spotting and in women seeking contraception. METHODS: We studied 65 women who had used OCs for more than 3 months and who presented with intermenstrual spotting for which no readily demonstrable cause could be identified. They were compared with 65 matched controls who were taking OCs without intermenstrual spotting and who had chlamydia testing because of one or more risk factors, and 65 matched controls seeking contraception. The incidence of positive tests for each group was compared by chi 2 test for independence using the Yates formula. The strength of the relationship was analyzed by determining the Craemer phi coefficient. RESULTS: Nineteen of the 65 women (29.2%) taking OCs for more than 3 months and experiencing bleeding had positive tests, in contrast to seven of 65 matched controls (10.7%) who were also on OCs and who had had chlamydia testing because of vaginitis or new or multiple sexual consorts, and four of 65 women (6.1%) who were screened for C trachomatis before initiation of contraception. The significance level for the chi 2 statistic was P < .01. CONCLUSION: Intermenstrual bleeding in women previously well regulated on OCs appears to be an added marker for chlamydial infection.

Adult↗
PubMed2005

Quality of controlled clinical trials on glaucoma and intraocular high pressure.

AIM: To study the quality of controlled clinical trials on glaucoma. METHODS: Two hundred and twenty-six clinical trials published between 1980 and 1999 were selected from seven international ophthalmological journals. Their quality was assessed by four researchers with epidemiological skills using a structured questionnaire. RESULTS: Sample size was pre-estimated in 34 (15.0%) papers, which were of greater size (P = 0.05). Randomization was performed in 98.2% of the trials, although the procedure of randomization was scarcely reported. Masking was reported in 56.6% of the papers, and was more frequent in medical treatments (P < 0.001). The basal characteristics of the groups were compared in 139 papers (61.5%). Patient losses during the follow-up period were fully described in only 27 trials. Intention-to-treat analysis was used in 17 (7.7%) papers. Most trials reported P values, but a measure of effect (mean, proportion, or relative risk) appeared in only 16 trials (7.7%). Trials performed in the US more frequently compared baseline characteristics of the groups (P = 0.03), described the patient flow (P = 0.04), and used adequate statistical procedures (P = 0.03). Those trials that included a statistician or an epidemiologist among the authors were more commonly blinded (P = 0.06) and they always avoided the analyses of subgroups (P = 0.006). Several methodological issues have improved throughout the studied period. CONCLUSIONS: Several methodological characteristics should be improved when reporting a clinical trial on glaucoma. Using a checklist like that suggested by the CONSORT can help to achieve this.

Controlled Clinical Trials as Topic↗