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PubMed2000

Serotonergic targets in the treatment of antidepressant induced sexual dysfunction: a pilot study of granisetron and sumatriptan.

Antidepressant induced sexual dysfunction is a common adverse event that is particularly evident with serotonergic antidepressants. There is a paucity of clinical trial evidence on the treatment of this problem. While there is some evidence of involvement of the serotonin (5-HT2) receptor subtype in this phenomenon, other serotonergic receptor systems are not well studied. In this trial, 35 patients on maintenance therapy with a variety of serotonergic antidepressants, who reported antidepressant induced sexual dysfunction, were enrolled. Patients were given both granisetron 1 mg, and sumatriptan 100 mg, in a crossover design, to be used 1 h before intercourse. Sexual dysfunction was measured using the Feiger scale. There was a high dropout rate in the trial, reflecting both embarrassment with the pharmacological treatment of sexual dysfunction and difficulties with planning and timing the medication. Nevertheless, there was a significant effect of granisetron in this study, with scores decreasing from 23.7 (SD 2.52) to 16.0 (SD 6.42) on the Feiger scale (n = 14, P = 0.001, Wilcoxon sign rank test). Sumatriptan failed to show a significant change from baseline at the 0.01 level of significance. While the small sample size, high dropout rates and open label design are limitations to this study, it suggests efficacy of the granisetron in antidepressant induced sexual dysfunction and the role of the 5-HT3 receptor in this phenomenon.

Adult↗
PubMed2000

Initiation of and adherence to treatment for mental disorders: examination of patient advocate group members in 11 countries.

OBJECTIVE: Greater understanding of the help-seeking process is needed to reduce the level of unmet need for mental health treatment. DESIGN: Cross-sectional mail survey. STUDY POPULATION: The study population consisted of 3,516 respondents to a survey of members of 14 patient advocacy groups in 11 countries. Respondents reported whether they initiated and adhered to the treatment most recently recommended to them. OUTCOMES: Crude and adjusted likelihoods of initiating and adhering to recommended treatment were studied. RESULTS: The vast majority of respondents reported initiating the most recent treatment recommended to them (94%), and most of those who initiated treatment also adhered to such treatment (83%). Predictors of initiation by the respondents included higher levels of education, having pharmacotherapy recommended to the respondent, and having received explanations about the diagnosis and treatment. Predictors of adherence to therapy included male gender, receipt of pharmacotherapy, and presence of insurance coverage. Side effects were an important reported reason for treatment dropout, with 44% of respondents reporting lifetime treatment dropout due to side effects. CONCLUSIONS: Successful initiation and adherence to mental health treatments depend critically on patients' knowledge and awareness, clinicians' communication skills, treatment side effects, and barriers such as lack of insurance. Further study and intervention focused on these modifiable factors are needed to improve the adequacy of mental health treatment.

Adolescent↗
PubMedDate not supplied

A public health nursing early intervention program for adolescent mothers: outcomes from pregnancy through 6 weeks postpartum.

BACKGROUND: Adolescent pregnancy and parenting remain a major public concern because of their impact on maternal-child health and on the social and economic well-being of the nation. Federal welfare reform legislation has created an urgent need for community-based nursing intervention programs to improve health and social outcomes for disadvantaged adolescent mothers and to promote their self-sufficiency. OBJECTIVE: To evaluate the effects of an early intervention program (EIP) that uses a public health nursing model on health and social outcomes of adolescent mothers and their children and on the quality of mother-child interaction. METHODS: Pregnant adolescents referred to a county health department were randomly assigned to an experimental (EIP) or control (traditional public health nursing [TPHN]) group. The sample included 121 adolescents from predominantly minority and impoverished backgrounds who were followed from pregnancy through 6 weeks postpartum. Intense and comprehensive home visitation by public health nurses and preparation-for-motherhood classes were provided to adolescents in the EIP. Health outcomes were determined on the basis of medical record data. Other measures included maternal self-report on selected behaviors, nurse interviews, and the Nursing Child Assessment Teaching Scale (NCATS). RESULTS: Early findings indicate reduced premature birth and low-birth-weight (LBW) rates for young mothers receiving both forms of public health nursing care. No significant differences between groups were found for infant birth weight or type of delivery. Infants in the EIP had significantly fewer total days of birth-related hospitalization and rehospitalization than those in the TPHN group during the first 6 weeks of life (chi2(1) = 6.41; p = 0.01). Adolescents in the EIP demonstrated significantly more positive educational outcomes (e.g., lower school dropout rates) than those in the TPHN group (chi2(1) = 6.76; p < 0.009). CONCLUSIONS: The early findings of this study demonstrate that pregnant adolescents benefit from both traditional and more intense public health nursing care in terms of prenatal and perinatal outcomes. The EIP was associated with decreased infant morbidity during the first 6 weeks of life and decreased maternal school dropout. Long-term outcomes for the EIP are being evaluated.

Adolescent↗
PubMed1990

Predicting the academic performance of Asian, black, and Hispanic optometry students.

As optometry schools receive increasing numbers of Asian, Black, and Hispanic applications, it is appropriate for us to ask whether minority students differ in meaningful ways from nonminority students in measures used in admissions, and whether these variables have differential validity in predicting their achievement in optometry school. This study compares Asian, Black, Hispanic, and nonminority students at entry to the University of Houston College of Optometry (UHCO) from 1981 through 1986 and tests the validity of admissions indices to predict optometry grades, academic dropout, and high-level achievement for these ethnic groups. Although preoptometry grade point average (GPA) was the best predictor of optometry grades for all students, measures of verbal ability were additional predictors for Asian students and, for Black and Hispanic students, ability in study/reading and math were predictors. In addition, personality inventory measures and ratings of the competitiveness of the undergraduate institution were important in differentiating minority academic dropouts from retained students. Suggestions are made for optometry college programs which will enhance the probability of success for minority students.

Achievement↗
PubMed2006

Assessment of microsatellite instability in very small microdissected samples and in tumor samples that are contaminated with normal DNA.

Microsatellite instability (MSI) testing is important for the management of young patients with colonic adenocarcinoma. Biopsies can be small and can be contaminated by normal cells. It is not known how sample size or contamination by non-neoplastic cell populations affects the interpretation of MSI assays. Serial microdissection targets (0.75 to 5.5 mm) were obtained from cases with high-level MSI. Polymerase chain reaction was performed for the standard National Cancer Institute recommended markers and products were analyzed by capillary electrophoresis. DNA from a patient with a BAT25 polymorphism was used to determine the sensitivity of detecting an aberrant allele in otherwise normal DNA. In small targets, MSI was seen sporadically in the setting of low DNA concentration. The results for small targets ranged from 1/4 to 5/5 loci with MSI, secondary to allelic dropout. In the sensitivity study, the aberrant allele was detected only when present at a concentration of above 10%. Allelic dropout can lead to under-estimation of the presence of MSI in small tissue samples or samples with low DNA concentration. Contaminating normal cell DNA can mask the presence of MSI. MSI testing on tissue fragments that are <5.5 mm can lead to a false-negative MSI test.

Alleles↗
PubMedDate not supplied

Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study.

OBJECTIVE: This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg). DESIGN: Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years) diagnosed with depression (Montgomery-Asberg Depression Rating Scale [MADRS] scores > or = 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). RESULTS: Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups. CONCLUSIONS: Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.

Antidepressive Agents, Second-Generation↗
PubMed2006

Association between meibomian gland changes and aging, sex, or tear function.

PURPOSE: To study changes in the lid margin and meibomian glands and their association with aging, sex, and tear function. METHODS: We examined 354 eyes in 177 subjects (76 men and 101 women; 21-93 years; mean age, 63.0 +/- 14.3 years) with no ocular symptoms or ocular surface disorders. Anatomic changes in the lid margin were studied using slit-lamp biomicroscopy. Meibomian gland function and morphology were evaluated on the basis of meibum expression and meibography, respectively. Tear function and ocular surface epithelium were assessed with the Schirmer test, by tear film break-up time, and with a fluorescein staining test. RESULTS: Eyes with abnormal lid margin anatomy, hyposecretion of meibum, and meibomian gland dropout were seen in 26 (7.3%), 46 (12.4%), and 68 eyes (18.6%), respectively, with a significant association between each finding and aging (P = <0.0001, 0.0498, and <0.0001, respectively). In patients < or =69 years of age, no significant association was found between meibomian gland-related findings and sex. However, a high incidence of abnormal lid margin and gland dropout was noted in men > or =70 years of age compared with women. No significant association was found between changes in the lid margin and meibomian glands and tear function in patients > or =40 years of age. CONCLUSION: Among symptom-free subjects, we found that changes in the lid margin and meibomian glands were closely related to aging. Among elderly subjects, changes in the anatomic lid margin and meibomian gland morphology were observed more frequently in men than in women. Tear function showed no association with either changes in the lid margin or function of the meibomian glands.

Adult↗
PubMed2005

Tear film and ocular surface abnormalities after eyelid tattooing.

A 45-year-old woman who underwent eyelid tattooing 20 years earlier presented with decreased left vision and eye discomfort. Her ocular history revealed an uneventful LASIK procedure 4 years previously with epithelial problems of the flap followed by S. aureus keratitis. Resultant corneal opacity necessitated a deep lamellar keratoplasty performed 9 months prior to admission followed by frequent epithelial problems. At the time of admission, her left eye had a corneal epithelial defect and both lower eyelid margins revealed subepidermal pigmentation and keratinization. Her initial examination revealed tear instability with increased ocular surface staining scores and advanced tear film lipid layer abnormality in both eyes. Meibography showed bilateral total meibomian gland dropout. Treatment with autologous serum eye drops resulted in full epithelialization. Meibomian gland disease-specific therapy did not result in any change in breakup time, vital staining scores, tear film lipid layer interferometry grades, or glandular dropout state.

Eyelid Diseases↗
PubMed2004

Lamivudine for the treatment of hepatitis B virus-related liver disease after renal transplantation: meta-analysis of clinical trials.

BACKGROUND: Numerous reports have appeared on lamivudine use for the treatment of hepatitis B virus (HBV) infection after renal transplantation (RT). However, the efficacy and safety of lamivudine after RT remain unclear. METHODS: The authors evaluated the efficacy and safety of initial lamivudine monotherapy in RT recipients with hepatitis B by performing a systematic review of the literature with a meta-analysis of clinical trials. The primary outcomes were hepatitis B (HB) e antigen (Ag) and HBV-DNA clearance (as measures of efficacy); the secondary outcomes were biochemical response (as measures of efficacy), dropout rate, and lamivudine resistance (as measures of tolerability). The authors used the random effects model of DerSimonian and Laird, and outcomes were analyzed on an intent-to-treat basis. RESULTS: The authors identified 14 clinical trials (184 patients); all of these were prospective cohort studies. The mean overall estimate for HBV-DNA and HBeAg clearance, alanine aminotransferase normalization, and lamivudine resistance was 91% (95% confidence interval [CI], 86%-96%), 27% (95% CI, 16%-39%), 81% (95% CI, 70%-92%), and 18% (95% CI, 10%-37%), respectively. HBeAg seroconversion rate was assessed in four (28%) trials and ranged between 0% and 46%. The P value was greater than 0.05 for our test of study homogeneity. There was no association between rate of patients who were male patients or had cirrhosis, race, age, lamivudine dose, and HBV-DNA or HBeAg clearance. Increased duration of lamivudine therapy was positively associated with frequency of HBeAg loss (r =0.51, P =0.039) and lamivudine resistance (r =0.620, P =0.019). Only 2 (14%) of 14 studies reported a dropout rate greater than 0%. CONCLUSIONS: Our meta-analysis showed that the majority of RT recipients with hepatitis B had high virologic and biochemical response with lamivudine. Tolerance to lamivudine was good. However, lamivudine resistance was frequent with prolonged therapy, potentially limiting its long-term efficacy after RT.

DNA, Viral↗
PubMed2005

Hepatocellular carcinoma: interventional bridging to liver transplantation.

Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide with surgery being considered the treatment of choice. However, it is limited in view of the hepatic dysfunction and high recurrence rates associated with the disease. Liver transplantation offers the advantage of both, eradicating the tumor and treating the underlying liver disease and is the only chance for cure in patients suffering from HCC. Survival is known to reach 70% after 5 years and recurrent tumor can be found in less than 20% provided transplantation is restricted to patients with single tumors < or =5 cm or three nodules <3 cm (Milan criteria). However, donor organs are limited and the time on the transplant waiting list is up to 6 or 12 months in Europe and the United States with up to 30-40% dropouts per year. It has been demonstrated that patients with untreated HCC while on the waiting list longer than 6-10 months do not have any benefit in survival after liver transplantation. Interventional treatment options such as transarterial chemoembolization and percutaneous ablation techniques documented promising results concerning the reduction of dropouts from the waiting list and the potential risk for recurrent tumor. Mortality and morbidity were considerably low when radiological interventions had been considered as bridging therapies for liver transplantation. Percutaneous therapies come along with tumoral seeding of 0.1% to 0.6%. Adjuvant treatment with TACE, PEI, and/ or RFA in T1- and T2-staged HCC resulted in tumor-free survival after transplantation of 95.2% after 4 years and intention-to-treat survival of 94%, 85%, and 79% at 1, 2, and 3 years, respectively. Aggressive ablation therapy with a short transplant waiting time has the potential to optimize the use of liver transplantation for curative intent in selected cirrhotic HCC patients. Especially combined treatments seemed to play a key role in achieving complete tumor necrosis associated with improved disease-free survival after liver transplantation. In conclusion, no evidence based data exist in the literature supporting the efficacy of adjuvant interventional treatment modalities for HCC in patients awaiting liver transplantation. However, it has been shown that adjuvant (multimodal) interventional treatments seem a promising option for safe and effective bridging.

Carcinoma, Hepatocellular↗
PubMed2006

Pregnant teenager involvement in sexual activity and the social context.

UNLABELLED: Pregnancy during adolescence represents a challenge to society as a whole. Its incidence is increasing and brings about social and medical consequences to both the teen mothers and their children. The purpose of this study was to evaluate pregnant teenager involvement in sexual activity and the social context. The group studied comprised 152 pregnant teenagers attending the Department of Pediatrics, Santa Casa de Sao Paulo (SCSP) General Hospital. All information was analyzed. The age at first intercourse was 14.2 years and the average period between first intercourse and pregnancy was 1.4 years. Most pregnancies (75%) were neither planned nor wanted, however, most teen mothers (64.3%) did not use any contraceptive method. Of the pregnant teenagers, 68.1% came from unstructured families where in 71% of the teen pregnancy cases, there was a role model (mother, sister, or cousin who already experienced teen pregnancy). The average number of school years attended by the analyzed pregnant teenagers was 8.1 years, however, there was a high dropout rate of 40.1%. The age at first intercourse was low and concurs with the high incidence of unstructured families. The average number of school years attended was high, which would theoretically reflect a greater knowledge with regard to human reproduction, pointing to the multicausality of teen pregnancy and the role played by the family. CONCLUSIONS: We confirmed that teen pregnancy presents multicausal etiology; sexual initiation of pregnant teenagers was quite early with high dropout rates, which indicated that prevention methodology should be based on early detection of risk factors for elaboration of appropriate prevention proposals.

Abortion, Induced↗
PubMed2004

Delay-induced resonances in an optical system with feedback.

We study the influence of the delay time in the response of a delayed feedback system to external periodic driving. The nonlinear system we consider is a semiconductor laser with optical feedback operating in the low-frequency fluctuation regime. We numerically examine the consequences of varying the external cavity length of the system when a weak modulation is introduced through the laser's pump current. The harmonic modulation is seen to lead to a partial periodic entrainment of power dropouts, and the distribution of time intervals between the dropouts exhibits resonances with certain delay times. In other words, the response of the system to the external modulation is enhanced for particular values of the external cavity length. The same effect can be observed in the presence of noise, indicating that stochastic resonance can be enhanced or degraded depending on the feedback time.

Journal Article↗
PubMed2006

Observation of chaotic itinerancy in the light and carrier dynamics of a semiconductor laser with optical feedback.

We report a direct experimental observation of chaotic itinerancy in simultaneous measurements of the light intensity and voltage fluctuations of a laser diode exhibiting low-frequency fluctuations. The distribution of trajectories leading up to (following) an intensity dropout is computed from the experiment and reveals the presence of itinerant mechanisms before (after) dropout initiation. A phase space reconstruction of the trajectory for the optimal path of motion illustrates sudden shifts between low-dimensional attractor ruins and is shown to correspond to simulations of the laser intensity and carrier number.

Journal Article↗
PubMed2004

Latent pattern mixture models for informative intermittent missing data in longitudinal studies.

A frequently encountered problem in longitudinal studies is data that are missing due to missed visits or dropouts. In the statistical literature, interest has primarily focused on monotone missing data (dropout) with much less work on intermittent missing data in which a subject may return after one or more missed visits. Intermittent missing data have broader applicability that can include the frequent situation in which subjects do not have common sets of visit times or they visit at nonprescheduled times. In this article, we propose a latent pattern mixture model (LPMM), where the mixture patterns are formed from latent classes that link the longitudinal response and the missingness process. This allows us to handle arbitrary patterns of missing data embodied by subjects' visit process, and avoids the need to specify the mixture patterns a priori. One assumption of our model is that the missingness process is assumed to be conditionally independent of the longitudinal outcomes given the latent classes. We propose a noniterative approach to assess this key assumption. The LPMM is illustrated with a data set from a health service research study in which homeless people with mental illness were randomized to three different service packages and measures of homelessness were recorded at multiple time points. Our model suggests the presence of four latent classes linking subject visit patterns to homeless outcomes.

Biometry↗
PubMed1982

The recurrent coronary prevention project. Some preliminary findings.

The Recurrent Coronary Prevention Project (RCPP) was established as a 5-year clinical trial to examine two basic questions: --1. Can the recurrence rate of post-coronary subjects be substantially reduced over a 5-year period by means of a programme of behavioural change, in comparison with treatment by cardiologists focussing on medication, diet, exercise and cardiovascular issues, and with subjects who only receive regular care from their own physician? 2. Can the Type A behaviour pattern (TABP) be changed and do such changes correspond to reduced recurrences of coronary heart disease (CHD) over a 5 year period? To answer these questions, four major treatment groups are currently being compared: --1. A small group treatment programme (Section I) led by cardiologists emphasizing adherence to medication, diet and exercise, and giving cardiovascular and cardiological information. 2. A behavioural change treatment programme (Section II) based primarily on a cognitive social learning model and attempting to alter TABP. 3. A control group of subjects assessed annually and receiving private medical care from their own physicians. 4. A dropout comparison group composed of subjects voluntarily discontinuing participation in groups led by cardiologists or in behavioural change groups. Results to date show a significantly reduced rate of recurrence for subjects in the behavioural change group, compared to those in the groups led by cardiologists as well as control and dropout groups. These significantly lower recurrence rates are accompanied by data suggesting that subjects in the behavioural change programme are also altering their TABP as measured by both behavioural questionnaires and videotaped Type A structured interviews. Clinical impressions suggest that treatment programmes to alter TABP should consider the primary importance of the personal meaning of the TABP and other behaviours to the individual concerned, particularly how basic underlying beliefs set the stage for the TABP. The central role of hostility as a pervasive orientation towards self and others is emphasized, as are issues of excessive controllability related to extreme competitiveness and hyper-arousal. The multiple roles of group leaders, especially as social models for coping, and the impact of the small groups settings, is also discussed.

Behavior Therapy↗
PubMed1993

Carpal tunnel syndrome and gynaecomastia during growth hormone treatment of elderly men with low circulating IGF-I concentrations.

OBJECTIVE: We studied the relationship between plasma level of insulin-like growth hormone I (IGF-I), changes in lean body mass and in adipose mass, and adverse side-effects during human growth hormone (hGH) treatment of elderly men who had low IGF-I levels. DESIGN: The first six months was a period of baseline observation. The subjects were then randomized into two groups so that during months 7-18, men in group I received hGH, and men in group II served as untreated controls. SUBJECTS: Eighty-three overtly healthy elderly men, who were selected because their plasma IGF-I level was less than 0.35 units/ml. The men were randomly assigned in a ratio of three to one into group I (n = 62) or into group II (n = 21). MEASUREMENTS: Plasma IGF-I level was measured monthly. Lean body mass and adipose mass were measured every six months. RESULTS: Fifteen men left the study during the baseline period because of personal reasons or intercurrent medical events. In those who received drug (group I), there were a number of adverse reactions which could have been related to the hGH therapy: carpal tunnel syndrome 10, gynaecomastia 4, and hyperglycaemia 3. In total there were 27 dropouts from group I and two dropouts from group II after the six-month point, for a variety of medical and non-medical reasons, the majority probably not related to hGH therapy. During the hGH treatment of group I, plasma IGF-I increased from the range 0.10-0.35 units/ml into the range 0.5-2.2 units/ml. Among the 18 men who completed 12 months of hGH treatment without experiencing one of the three above-noted presumed hGH side-effects, mean and peak plasma IGF-I during treatment were significantly lower than among the 13 men who experienced carpal tunnel syndrome or gynaecomastia (one subject had both) while on hGH. With one exception, neither carpal tunnel syndrome nor gynaecomastia occurred in any individual with a mean IGF-I level less than 1.0 units/ml during hGH treatment. Twelve months of hGH treatment (group I) caused an increase in lean body mass to 106% of the initial baseline (month one of the protocol), and a reduction in adipose mass to 84% of the baseline. Meanwhile, the lean body mass of the untreated men in group II declined to 97% of the initial baseline. The body composition responses after 12 months of treatment in group I were larger in the men whose mean intra-treatment IGF-I level was 0.5-1.0 units/ml, than in the men whose mean intra-treatment IGF-I level was 1.0-1.5 units/ml. CONCLUSIONS: These observations show that when elderly men with low circulating IGF-I concentrations are treated continuously with hGH, elevation of plasma IGF-I above 1.0 units/ml is associated with a substantial frequency of carpal tunnel syndrome or gynaecomastia. It may be that the effects of the hormone in expanding lean body mass and reducing adipose mass can be achieved, and the side-effects avoided, by maintaining the mean IGF-I level in the range 0.5-1.0 units/ml.

Adipose Tissue↗
PubMed2004

Efficacy of theophylline compared to methylphenidate for the treatment of attention-deficit hyperactivity disorder in children and adolescents: a pilot double-blind randomized trial.

Attention-deficit hyperactivity disorder (ADHD) is a common disorder of childhood that affects 3-6% of school children. Conventional stimulant medications are recognized as useful symptomatic treatments by both specialists and parents. Nevertheless, approximately 30% of ADHD children treated with them do not respond adequately or cannot tolerate the associated adverse effects. Such difficulties highlight the need for alternative, safe and effective medications in the treatment of this disorder. Theophylline is a psychomotor stimulant most widely used as a broncodilator. Purinergic modulation may be therapeutically beneficial in the treatment of psychiatric disorders. We hypothesized that theophylline would be beneficial for the treatment of ADHD and report results of a trial of theophylline compared with methylphenidate for the treatment of ADHD. A total of 32 children with ADHD as defined by DSM IV were randomized to theophylline and methylphenidate dosed on an age and weight-adjusted basis at 4 mg/kg/day (under 12 years) and 3 mg/kg/day theophylline (over 12 years) (group 1) and 1 mg/kg/day methylphenidate (group 2) for a 6-week double-blind and randomized clinical trial. The principal measure of the outcome was the Teacher and Parent ADHD Rating Scale. Patients were assessed by a child psychiatrist, at baseline and at 14, 28 and 42 days after start of the medication. No significant differences were observed between theophylline and methylphenidate on the Parent and Teacher Rating Scale scores over the trial (t = 0.49, d.f. = 24 P = 0.62 and t = 0.19, d.f. = 24 P = 0.54 respectively). Although the number of dropouts in the methylphenidate group was higher than the theophylline group, there was no significant difference between the two protocols in terms of the dropouts. In addition, headaches were observed more often in the methylphenidate group. The results suggest that theophylline may be a useful for the treatment of ADHD. In addition, a tolerable side-effect profile is one of the advantages of theophylline in the treatment of ADHD. Nevertheless, our study is small and our results would need to be confirmed in a larger study.

Adolescent↗
PubMed2005

Appraising the quality of randomized controlled trials: inter-rater reliability for the OTseeker evidence database.

RATIONALE AND AIMS: 'OTseeker' is an online database of randomized controlled trials (RCTs) and systematic reviews relevant to occupational therapy. RCTs are critically appraised and rated for quality using the 'PEDro' scale. We aimed to investigate the inter-rater reliability of the PEDro scale before and after revising rating guidelines. METHODS: In study 1, five raters scored 100 RCTs using the original PEDro scale guidelines. In study 2, two raters scored 40 different RCTs using revised guidelines. All RCTs were randomly selected from the OTseeker database. Reliability was calculated using Kappa and intraclass correlation coefficients [ICC (model 2,1)]. RESULTS: Inter-rater reliability was 'good to excellent' in the first study (Kappas >or= 0.53; ICCs >or= 0.71). After revising the rating guidelines, the reliability levels were equivalent or higher to those previously obtained (Kappas >or= 0.53; ICCs >or= 0.89), except for the item, 'groups similar at baseline', which still had moderate reliability (Kappa = 0.53). In study 2, two PEDro scale items, which had their definitions revised, 'less than 15% dropout' and 'point measures and variability', showed higher reliability. In both studies, the PEDro items with the lowest reliability were 'groups similar at baseline' (Kappas = 0.53), 'less than 15% dropout' (Kappas <or= 0.68) and 'point measures and variability data' (Kappas <or= 0.68). CONCLUSION: The PEDro scale is a reliable instrument for rating the quality of RCTs. Revised rating guidelines are provided for scale items that are difficult to rate, and helped to improve inter-rater reliability.

Australia↗