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Biomedical subjects

Mark Davies

Publications and source records attributed to Mark Davies.

At least 19 recordsLinked to original sources
PubMed2026

Challenges in identifying paediatric cancer predisposition syndromes: international SCOPE survey and SIOPE expert consensus recommendations.

Cancer Predisposition Syndromes (CPS) are heritable genetic conditions associated with an increased risk of developing various cancers throughout life. While early identification and tumour surveillance can improve outcomes, CPS are often underdiagnosed in clinical practice. To evaluate clinicians' perspectives and identify barriers to CPS identification and care across Europe, we conducted the SCOPE study: a three-part cross-sectional survey of paediatric haematology/oncology professionals, followed by a modified Delphi consensus process with members of the SIOP Europe Host Genome Working Group. A total of 185 paediatric oncologists from 22 countries participated in the survey. More than 40% of participants reported low or uncertain confidence across different CPS-related tasks, particularly in counselling families (64.3%) and interpreting germline genetic findings (57.3%). Access to clinical geneticists and dedicated CPS clinics were predictors of higher confidence for some domains, while individual experience and institutional patient volume had limited influence. Regular use of universal CPS screening tools was low (42.3%), with most clinicians relying on personal judgement rather than structured criteria. The most cited barriers were lack of screening guidelines (57%) and difficulties in interpreting results (35.1%). Regular training and workshops, availability of genetic counsellors or educators for patient support, and patient-friendly education material were most cited as areas of improvement. The Delphi process led to three recommendations: (1) improve clinician training and communication strategies, (2) integrate CPS screening into standard treatment plans, and (3) develop accessible, patient-centred educational materials. These recommendations highlight opportunities to enhance CPS care through structured support, interdisciplinary collaboration, and systematic screening approaches.

Humans↗
PubMed2005

Evaluating iatrogenic risk of youth suicide screening programs: a randomized controlled trial.

CONTEXT: Universal screening for mental health problems and suicide risk is at the forefront of the national agenda for youth suicide prevention, yet no study has directly addressed the potential harm of suicide screening. OBJECTIVE: To examine whether asking about suicidal ideation or behavior during a screening program creates distress or increases suicidal ideation among high school students generally or among high-risk students reporting depressive symptoms, substance use problems, or suicide attempts. DESIGN, SETTING, AND PARTICIPANTS: A randomized controlled study conducted within the context of a 2-day screening strategy. Participants were 2342 students in 6 high schools in New York State in 2002-2004. Classes were randomized to an experimental group (n = 1172), which received the first survey with suicide questions, or to a control group (n = 1170), which did not receive suicide questions. MAIN OUTCOME MEASURES: Distress measured at the end of the first survey and at the beginning of the second survey 2 days after the first measured on the Profile of Mood States adolescent version (POMS-A) instrument. Suicidal ideation assessed in the second survey. RESULTS: Experimental and control groups did not differ on distress levels immediately after the first survey (mean [SD] POMS-A score, 5.5 [9.7] in the experimental group and 5.1 [10.0] in the control group; P = .66) or 2 days later (mean [SD] POMS-A score, 4.3 [9.0] in the experimental group and 3.9 [9.4] in the control group; P = .41), nor did rates of depressive feelings differ (13.3% and 11.0%, respectively; P = .19). Students exposed to suicide questions were no more likely to report suicidal ideation after the survey than unexposed students (4.7% and 3.9%, respectively; P = .49). High-risk students (defined as those with depression symptoms, substance use problems, or any previous suicide attempt) in the experimental group were neither more suicidal nor distressed than high-risk youth in the control group; on the contrary, depressed students and previous suicide attempters in the experimental group appeared less distressed (P = .01) and suicidal (P = .02), respectively, than high-risk control students. CONCLUSIONS: No evidence of iatrogenic effects of suicide screening emerged. Screening in high schools is a safe component of youth suicide prevention efforts.

Adolescent↗
PubMed2005

On the measurement of nicotine dependence in adolescence: comparisons of the mFTQ and a DSM-IV-based scale.

OBJECTIVE: To compare nicotine-dependent smokers identified by the modified Fagerström Tolerance Questionnaire (mFTQ) and a scale based on the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), in a multiethnic adolescent sample. METHODS: A school survey was conducted on 6th- to 10th-grade students (N=15,007) in a large urban public school system. RESULTS: The two scales formed two distinct factors. The concordance between the two classifications of nicotine dependence was low. The DSM identified a much larger number of nicotine-dependent smokers than the mFTQ, mostly because smokers met dependence criteria at much lower levels of cigarettes consumed, especially when they were depressed. Rates of dependence were higher among whites than minority-group members, especially African Americans. Control for level of cigarette consumption attenuated or eliminated ethnic differences. CONCLUSIONS: This investigation provides some understanding of youths defined as dependent by each scale but cannot by itself indicate which scale better measures dependence. Differences in dependence rates among ethnic groups are accounted for mostly by quantity of cigarettes smoked.

Adolescent↗
PubMed2005

Research knowledge among parents of children participating in a randomized clinical trial.

OBJECTIVE: Parental permission is required for child research, but parents' understanding of research aims and procedures has not been well documented. Parental research knowledge was assessed during a clinical trial in autism. METHOD: Parents of 101 children (age 5-17 years) with autism participating in a placebo-controlled trial of risperidone were given a questionnaire at the end of the study. RESULTS: Of the 95 parents completing the questionnaire, 99% knew of possible placebo assignment and that testing the medication efficacy was the main purpose of the investigators; 96% to 98% knew that research involved both risks and potential benefits, identified the study medication, and knew of their right to withdraw at any time; 90% to 95% knew of the medication's main side effects; 87% reported having been informed of possible alternatives to research participation; and 72% were aware that treatment was randomly assigned (whereas 27% reported that treatment was chosen based on individual needs to ensure best care). Parents with a college degree were more likely to recognize the random nature of treatment assignment. CONCLUSIONS: Overall, parents were highly knowledgeable of the main research components. About one fourth, however, seemed unaware that treatment was randomly determined and not personalized, suggesting that therapeutic misconception may affect some otherwise well-informed parents.

Adolescent↗
PubMed2005

Sequential pharmacotherapy for children with comorbid attention-deficit/hyperactivity and anxiety disorders.

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is often accompanied by clinically significant anxiety, but few empirical data guide treatment of children meeting full DSM-IV criteria for ADHD and anxiety disorders (ADHD/ANX). This study examined the efficacy of sequential pharmacotherapy for ADHD/ANX children. METHOD: Children, age 6 to 17 years, with ADHD/ANX were titrated to optimal methylphenidate dose and assessed along with children who entered the study on a previously optimized stimulant. Children with improved ADHD who remained anxious were randomly assigned to 8 weeks of double-blind stimulant + fluvoxamine (STIM/FLV) or stimulant + placebo (STIM/PL). Primary efficacy measures were the Swanson, Nolan, Atkins, and Pelham IV Parent and Teacher Rating Scale ADHD score and the Pediatric Anxiety Rating Scale total score. ADHD, ANX, and overall Clinical Global Impressions-Improvement scores were also obtained. RESULTS: Of the 32 medication-naive children openly treated with methylphenidate, 26 (81%) improved as to ADHD. Twenty-five children entered the randomized trial. Intent-to-treat analysis indicated no differences between the STIM/FLV (n = 15) and STIM/PL groups on the Pediatric Anxiety Rating Scale or Clinical Global Impressions-Improvement-defined responder rate. Medications in both arms were well tolerated. CONCLUSIONS: Children with ADHD/ANX have a response rate to stimulants for ADHD that is comparable with that of children with general ADHD. The benefit of adding FLV to stimulants for ANX remains unproven.

Adolescent↗
PubMed2005

The Brief Impairment Scale (BIS): a multidimensional scale of functional impairment for children and adolescents.

OBJECTIVE: This article provides the results of the psychometric testing of the Brief Impairment Scale (BIS). The BIS is a 23-item instrument that evaluates three domains of functioning: interpersonal relations, school/work functioning, and self-care/self-fulfillment. It capitalizes on the strengths of existing global measures while addressing some of their limitations. METHOD: Cross-sectional parent respondent data from one clinical (N = 757) and two community samples (N = 1,888 and 1,132) of children ranging in age from 4 to 17 years is employed to test the reliability and validity of the BIS. Receiver operating characteristic analyses are employed to assess useful cutoff scores on the scale. RESULTS: The total scale's internal consistency ranged from 0.81 to 0.88 and from 0.56 to 0.81 on the three subscales. Test-retest reliability for individual items ranged from fair to substantial in all but six items. The BIS has high convergent and concurrent validity. Receiver operator characteristic analyses suggest possible thresholds for different uses. CONCLUSIONS: The BIS is psychometrically sound, useful in assessments and as an outcome measure in clinical practice and research. Its advantages over other global impairment instruments are that it is respondent based, short in administration time, and multidimensional.

Adolescent↗
PubMed2005

Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology.

OBJECTIVE: Risperidone has been found efficacious for decreasing severe tantrums, aggression, and self-injurious behavior in children and adolescents with autistic disorder (autism). The authors report on whether risperidone improves the core symptoms of autism, social and communication impairment and repetitive and stereotyped behavior. METHOD: The database from an 8-week double-blind, placebo-controlled trial (N=101) and 16-week open-label continuation study (N=63) of risperidone for children and adolescents with autism was used to test for drug effects on secondary outcome measures: scores on the Ritvo-Freeman Real Life Rating Scale, the Children's Yale-Brown Obsessive Compulsive Scale, and the maladaptive behavior domain of the Vineland Adaptive Behavior Scales. RESULTS: Compared to placebo, risperidone led to a significantly greater reduction in the overall score on the Ritvo-Freeman Real Life Rating Scale, as well as the scores on the subscales for sensory motor behaviors (subscale I), affectual reactions (subscale III), and sensory responses (subscale IV). No statistically significant difference was observed, however, on the subscale for social relatedness (subscale II) or language (subscale V). Risperidone also resulted in significantly greater reductions in scores on the Children's Yale-Brown Obsessive Compulsive Scale and Vineland maladaptive behavior domain. This pattern of treatment response was maintained for 6 months. CONCLUSIONS: Risperidone led to significant improvements in the restricted, repetitive, and stereotyped patterns of behavior, interests, and activities of autistic children but did not significantly change their deficit in social interaction and communication. Further research is necessary to develop effective treatments for the core social and communicative impairments of autism.

Adolescent↗
PubMed2004

Nine months of multicomponent behavioral treatment for ADHD and effectiveness of MTA fading procedures.

We examined 9-month data from the 14-month NIMH Multimodal Treatment Study of Children with ADHD (the MTA) as a further check on the relative effect of medication (MedMgt) and behavioral treatment (Beh) for attention-deficit/hyperactivity disorder (ADHD) while Beh was still being delivered at greater intensity than at 14-month endpoint, and conversely as a check on the efficacy of the MTA behavioral generalization/maintenance procedures. Intention-to-treat analysis at 9 months showed essentially the same results as at 14 months, after Beh had been completely faded; MedMgt and the combination (Comb) of medication and Beh were significantly superior to Beh and community care (CC) for ADHD and oppositional-defiant (ODD) symptoms, with mixed results for social skills and internalizing symptoms. All treatment-group differences examined as changes in slopes from 9 to 14 months were nonsignificant (we found general improvement for all groups). Slopes from baseline to 9 months correlated highly (r > .74, p < .0001) with slopes from baseline to 14 months for all groups. The time function from baseline to 14 months showed a significant linear, but not quadratic, trend for the main outcome measure (a composite of parent- and teacher-rated ADHD and ODD symptoms) for all groups. Findings suggest that in contrast to the hypothesized deterioration in the relative benefit of Beh between 9 and 14 months (after completion of fading), the MTA Beh generalization and maintenance procedures implemented through 9 months apparently yielded continuing improvement through 14 months, with preservation of the relative position of Beh compared to other treatment strategies.

Analysis of Variance↗
PubMed2004

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology.

OBJECTIVE: To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods. METHOD: Trained clinicians administered the Safety Monitoring Uniform Report Form (SMURF) to 59 parents and outpatients (mean age +/- SD = 11.9 +/- 3.2 years) in treatment, with 36% on stimulants, 29% on selective serotonin reuptake inhibitor drugs, 10% on both, and 25% on other drug combinations. The SMURF included a brief general inquiry, a drug-specific inquiry, and a comprehensive body system review (BSR). RESULTS: SMURF administration took 24.6 +/- 13.9 minutes (median, 21). The BSR took 15.5 +/- 8.1 minutes (median, 14) longer (p < .0001) than the general inquiry (4.3 +/- 5.4 minutes) and the drug-specific inquiry (4.2 +/- 2.9 minutes). The general inquiry elicited 48 AEs, the drug-specific inquiry elicited 16 additional AEs, and the BSR 129 additional AEs. Of all the clinically relevant AEs elicited by the SMURF (n = 36), 19 (53%) were elicited by the BSR. The BSR length and detail were acceptable to parents but not to clinicians. CONCLUSIONS: The BSR elicited additional clinically significant AEs that had been missed with less detailed methods. Parents, but not clinicians, rated satisfaction and acceptability of the BSR as good.

Adolescent↗
PubMed2004

Preclinical evaluation of a vaccine based on conserved region of M protein that prevents group A streptococcal infection.

BACKGROUND & OBJECTIVES: Infection with group A Streptococcus (GAS) may result in a number of human diseases ranging from the relatively benign pharyngitis to the potentially life-threatening invasive diseases and post-infectious sequelae. We have previously defined a minimal B-cell epitope from the conserved region of the M-protein. Here we report on the immunogenicity, opsonic potential of the resulting sera and the level of protection induced by this peptide in comparison to a pepsin extract of the M protein. METHODS: Inbred mice were immunized with peptides derived from the M protein. Sera were collected from the immunized mice and its opsonic potential determined for M1 and M6 GAS strains. Mice were then intranasally challenged with a virulent M1 GAS strain to determine the protective efficacy of the peptides. RESULTS: The peptides induced significant antibody responses when delivered subcutaneously and immunized mice demonstrated significantly enhanced survival compared to control groups following challenge. INTERPRETATION & CONCLUSION: The data obtained in the present study indicated that the chimeric peptide J8 from the conserved region of the M protein could form the basis for an anti-streptococcal vaccine in future.

Amino Acid Sequence↗
PubMed2003

Response to methylphenidate in children with attention deficit hyperactivity disorder and manic symptoms in the multimodal treatment study of children with attention deficit hyperactivity disorder titration trial.

OBJECTIVE: Recent reports raise concern that children with attention deficit hyperactivity disorder (ADHD) and some manic symptoms may worsen with stimulant treatment. This study examines the response to methylphenidate in such children. METHODS: Data from children participating in the 1-month methylphenidate titration trial of the Multimodal Treatment Study of Children with ADHD were reanalyzed by dividing the sample into children with and without some manic symptoms. Two "mania proxies" were constructed using items from the Diagnostic Interview Schedule for Children (DISC) or the Child Behavior Checklist (CBCL). Treatment response and side effects are compared between participants with and without proxies. RESULTS: Thirty-two (11%) and 29 (10%) participants fulfilled criteria for the CBCL mania proxy and DISC mania proxy, respectively. Presence or absence of either proxy did not predict a greater or lesser response or side effects. CONCLUSION: Findings suggest that children with ADHD and manic symptoms respond robustly to methylphenidate during the first month of treatment and that these children are not more likely to have an adverse response to methylphenidate. Further research is needed to explore how such children will respond during long-term treatment. Clinicians should not a priori avoid stimulants in children with ADHD and some manic symptoms.

Attention Deficit Disorder with Hyperactivity↗
PubMed2003

An open trial of fluoxetine for adolescents with bulimia nervosa.

OBJECTIVE: This open clinical trial examined the feasibility, tolerability, and efficacy of treating adolescents who suffer from bulimia nervosa with fluoxetine. METHODS: Ten adolescents, ages 12-18 years received 8 weeks of fluoxetine 60 mg/day with supportive psychotherapy. Primary outcome measures included frequencies of binge eating and purging and ratings on the Clinical Global Impressions-Improvement scale (CGI-I). Secondary outcome measures included self-report measures of eating disorder, depression, and anxiety symptoms. Safety and tolerability of this dose of fluoxetine were also assessed. RESULTS: Average weekly binges decreased significantly from 4.1 +/- 3.8 to 0 (p < 0.01). Average weekly purges decreased significantly from 6.4 +/- 5.2 to 0.4 +/- 0.9 (p < 0.005). All patients improved on the CGI-I scale, with 20% rated as much improved, 50% improved, and 30% slightly improved. All subjects tolerated the 60-mg dose of fluoxetine, and there were no dropouts due to adverse effects from the medication. DISCUSSION: Fluoxetine is generally well tolerated and may be an effective treatment option for adolescents with bulimia nervosa.

Adolescent↗
PubMed2003

Recall of childhood psychopathology more than 10 years later.

OBJECTIVE: This study investigated recall in a sample of depressed, anxious, and normal children followed up as adults. Strengths of this study were that the length of the retest interval was substantial, follow-up information was collected by blind interviewers, and childhood diagnoses were clearly documented. METHOD: The sample consisted of 144 subjects with a childhood diagnosis of depression, 48 with a childhood diagnosis of anxiety, and 128 normal controls. Best-estimate diagnoses assigned at follow-up were compared with childhood primary diagnoses. RESULTS: Reliability and sensitivity were fair for major depressive disorder (mean = 0.46 and 50%, respectively) and any depression (mean = 0.57 and 65%, respectively). Reliability and sensitivity were relatively lower for anxiety (mean = 0.32 and 43%, respectively). Sensitivity for any diagnosis was good (mean = 71%). Specificity was good among all diagnostic categories (range = 73%-100%). Results suggest better diagnostic recall for females than for males. Recall was slightly better for subjects who were older than age 12 during their original episode. Age-of-onset reliability was poor (major depressive disorder = 0.22, any depression = 0.22, and any anxiety = -0.13). CONCLUSIONS: Recall of any childhood disorder is moderately reliable and accurate. Recall of a specific disorder is less accurate. Depression was more likely to be recalled than anxiety. High specificity suggests that participants were not biased to report disorders not present in childhood.

Adolescent↗
PubMed2003

Searching for moderators and mediators of pharmacological treatment effects in children and adolescents with anxiety disorders.

OBJECTIVE: To examine whether age, gender, ethnicity, type of anxiety disorder, severity of illness, comorbidity, intellectual level, family income, or parental education may function as moderators and whether treatment adherence, medication dose, adverse events, or blinded rater's guess of treatment assignment may function as mediators of pharmacological treatment effect in children and adolescents with anxiety disorders. METHOD: The database of a recently reported double-blind placebo-controlled trial of fluvoxamine in 128 youths was analyzed. With a mixed-model random-effects regression analysis of the Pediatric Anxiety Rating Scale total score, moderators and mediators were searched by testing for a three-way interaction (strata by treatment by time). A two-way interaction (strata by time) identified predictors of treatment outcome. RESULTS: No significant moderators of efficacy were identified, except for lower baseline depression scores, based on parent's (but not child's) report, being associated with greater improvement (p < .001). Patients with social phobia (p < .05) and greater severity of illness (p < .001) were less likely to improve, independently of treatment assignment. Blinded rater's guess of treatment assignment acted as a possible mediator (p < .001), but improvement was attributed to fluvoxamine, regardless of actual treatment assignment. Treatment adherence tended to be associated (p = .05) with improvement. CONCLUSIONS: In this exploratory study, patient demographics, illness characteristics, family income, and parental education did not function as moderators of treatment effect. Social phobia and severity of illness predicted less favorable outcome. Attribution analyses indicated that study blindness remained intact. The presence of concomitant depressive symptoms deserves attention in future treatment studies of anxious children.

Adolescent↗
PubMed2003

Parent-defined target symptoms respond to risperidone in RUPP autism study: customer approach to clinical trials.

OBJECTIVE: A consumer-oriented efficacy assessment in clinical trials should measure changes in chief complaint and consumer request (symptoms of most concern to patient/caregiver), which may be diluted in change scores of multisymptom scales. METHOD: In the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network 8-week double-blind trial of risperidone versus placebo, the chief concerns of parents were collected at 0, 4, and 8 weeks (endpoint), in addition to standardized primary measures. Blinded clinical judges rated change from baseline to 4 and 8 weeks on a 9-point scale (1 = normalized, 5 = unchanged, 9 = disastrous); 94 participants had usable data. RESULTS: The most common symptoms identified by parents were tantrums, aggression, and hyperactivity. Interrater reliability was excellent. Mean ratings at endpoint were 2.8 +/- 1.2 on risperidone and 4.5 +/- 1.3 on placebo (p <.001). Ratings were collinear with Clinical Global Impression-Improvement and Aberrant Behavior Checklist Irritability subscale (primary dimensional measure). Effect size d was 1.4, compared to 1.2 on the Aberrant Behavior Checklist Irritability subscale. Effect sizes varied twofold by symptom category, largest for self-injury (2.11) and tantrums (1.95). CONCLUSIONS: Risperidone was superior to placebo in reducing symptoms of most concern to parents of autistic children with irritable behavior. Rating individualized participant-chosen target symptoms seems a reliable, sensitive, efficient, and consumer-friendly way to assess treatment effect and might have clinical application.

Adolescent↗