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Predictors of child psychological changes during family-based treatment for obesity.

OBJECTIVE: To explore the influence of 1-year changes in child obesity and maternal psychopathology on changes in child psychological problems. DESIGN: Hierarchical regression models were used to predict child psychological change, with demographic variables, maternal psychological change, and child percentage overweight change as predictors. SETTING: Pediatric obesity research clinic. PARTICIPANTS: Clinic sample of 116 obese 8- to 12-year-old children and their mothers. INTERVENTIONS: Family-based behavioral weight-control program. MAIN OUTCOME MEASURES: Child psychopathology was assessed via mother-reported Child Behavior Checklists and maternal psychopathology was determined by standardizing scores on the Cornell Medical Index and the Symptoms Checklist-90-Revised. RESULTS: Significant improvements were observed in child percentage overweight (-20.1% overweight), and child and maternal psychopathology. Improved maternal psychopathology accounted for a significant amount of variance in improvements in the Child Behavior Checklist total Problems Scale and internalizing and externalizing problems subscales. Decreased obesity accounted for a significant amount of variance in improvements in the Total Competence scale and, somatic complaints, social problems and social competence subscales of the Child Behavior Checklist. Significant interactions of child obesity change by sex were found for Total Problems and externalizing scores. The interactions were due to girls with greater obesity reduction showing greater improvement in Total Problems, whereas boys with greater obesity reduction showed less improvement in externalizing problems. CONCLUSIONS: These results highlight the multidimensional nature of psychosocial functioning in obese children and call attention to multiple avenues for intervention to improve their psychosocial functioning.

Adult↗

The psychological effects of parental human immunodeficiency virus infection on uninfected children.

OBJECTIVES: To assess the mental health of children of mothers infected with the human immunodeficiency virus. DESIGNS: Matched comparison of 26 children of mothers infected with the human immunodeficiency virus and 26 children with no experience of human immunodeficiency virus infection within their families. SETTINGS: Subject children were identified through hospital acquired immunodeficiency syndrome clinics and comparison children were identified through the primary care center of the same hospital. PARTICIPANTS: Subjects and controls were aged 6 to 16 years and matched by age, sex, race, and maternal marital and employment status. MAIN OUTCOME MEASURES: Parents completed the Child Behavior Checklist and the children completed the Revised Children's Manifest Anxiety Scale and the Children's Depression Inventory. RESULTS: Controlling for confounding variables, subjects were found by the Child Behavior Checklist to be significantly more withdrawn (P < .05) and to have more problems with attention (P < .005) than controls, although total Child Behavior Checklist scores were not significantly different. Compared with control children, the subject children reported more depression on the Children's Depression Inventory (P < .05) but were not more anxious. However, compared with children of asymptomatic mothers, the children of symptomatic mothers were reported to be significantly more anxious and/or depressed on the Child Behavior Checklist (P < .01) and the children reported more anxiety on the Revised Children's Manifest Anxiety Scale (P < .05). CONCLUSIONS: This study focusing specifically on uninfected children in families affected by the human immunodeficiency virus demonstrates some of the psychological ramifications of this disease. Larger studies are required to identify factors that contribute to the vulnerabilities and resilience of such children. Attention needs to focus on ameliorating these adverse effects on the children of the acquired immunodeficiency syndrome epidemic.

Acquired Immunodeficiency Syndrome↗

Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.

OBJECTIVE: Because of the pressure for timely, informed decisions in public health and clinical practice and the explosion of information in the scientific literature, research results must be synthesized. Meta-analyses are increasingly used to address this problem, and they often evaluate observational studies. A workshop was held in Atlanta, Ga, in April 1997, to examine the reporting of meta-analyses of observational studies and to make recommendations to aid authors, reviewers, editors, and readers. PARTICIPANTS: Twenty-seven participants were selected by a steering committee, based on expertise in clinical practice, trials, statistics, epidemiology, social sciences, and biomedical editing. Deliberations of the workshop were open to other interested scientists. Funding for this activity was provided by the Centers for Disease Control and Prevention. EVIDENCE: We conducted a systematic review of the published literature on the conduct and reporting of meta-analyses in observational studies using MEDLINE, Educational Research Information Center (ERIC), PsycLIT, and the Current Index to Statistics. We also examined reference lists of the 32 studies retrieved and contacted experts in the field. Participants were assigned to small-group discussions on the subjects of bias, searching and abstracting, heterogeneity, study categorization, and statistical methods. CONSENSUS PROCESS: From the material presented at the workshop, the authors developed a checklist summarizing recommendations for reporting meta-analyses of observational studies. The checklist and supporting evidence were circulated to all conference attendees and additional experts. All suggestions for revisions were addressed. CONCLUSIONS: The proposed checklist contains specifications for reporting of meta-analyses of observational studies in epidemiology, including background, search strategy, methods, results, discussion, and conclusion. Use of the checklist should improve the usefulness of meta-analyses for authors, reviewers, editors, readers, and decision makers. An evaluation plan is suggested and research areas are explored.

Epidemiology↗

Specific symptomatic changes following donepezil treatment of Alzheimer's disease: a multi-centre, primary care, open-label study.

BACKGROUND: Standard measurement scales used in anti-dementia trials may not capture symptomatic changes recognized by clinicians and caregivers. We studied a symptom checklist, completed separately by caregivers and by clinicians, to identify patterns of change associated with donepezil treatment. METHODS: In a multi-centre, 6-month, open-label study of 101 primary care patients, changes in a 19-symptom checklist were assessed in relation to changes in standardized scales of cognition, activities of daily living, behavior, and caregiver burden. RESULTS: Three symptoms were reported in more than 80% of patients by both clinicians and caregivers: problems in remembering, (97%), temporal orientation (89%), and repetitiveness (85%). Five others overlapped on each of the clinician and caregiver 'top ten', including cognitive activation, spatial orientation, leisure, attention, and apathy. Clinicians reported that symptoms did not improve in 38 patients, whereas there was some improvement in 43, and improvement in most symptoms in 20. Caregivers reported that symptoms did not improve in 55 patients, whereas 27 and 19 patients showed some and most symptoms improving respectively. Patients with the greatest symptomatic improvement also improved most on the ADAS-Cog and the other standardized measures, whereas no improvement (or decline) in each standardized measure was observed in people whose symptoms worsened or did not improve. CONCLUSION: A symptom checklist allowed clinically meaningful profiles to be identified, but revealed different estimates of response between clinicians and caregivers. Both agreed that improved executive function was the most common response. A symptom checklist can help translate between standard measures and everyday practice.

Activities of Daily Living↗

Validity and reliability of undergraduate performance assessments in an anesthesia simulator.

PURPOSE: To examine the validity and reliability of performance assessment of undergraduate students using the anesthesia simulator as an evaluation tool. METHODS: After ethics approval and informed consent, 135 final year medical students and 5 elective students participated in a videotaped simulator scenario with a Link-Med Patient Simulator (CAE-Link Corporation). Scenarios were based on published educational objectives of the undergraduate curriculum in anesthesia at the University of Toronto. During the simulator sessions, faculty followed a script guiding student interaction with the mannequin. Two faculty independently viewed and evaluated each videotaped performance with a 25-point criterion-based checklist. Means and standard deviations of simulator-based marks were determined and compared with clinical and written evaluations received during the rotation. Internal consistency of the evaluation protocol was determined using inter-item and item-total correlations and correlations of specific simulator items to existing methods of evaluation. RESULTS: Mean reliability estimates for single and average paired assessments were 0.77 and 0.86 respectively. Means of simulator scores were low and there was minimal correlation between the checklist and clinical marks (r = 0.13), checklist and written marks (r = 0.19) and clinical and written marks (r = 0.23). Inter-item and item-total correlations varied widely and correlation between simulator items and existing evaluation tools was low. CONCLUSIONS: Simulator checklist scoring demonstrated acceptable reliability. Low correlation between different methods of evaluation may reflect reliability problems with the written and clinical marks, or that different aspects are being tested. The performance assessment demonstrated low internal consistency and further work is required.

Anesthesiology↗

Bimodal assessment of laparoscopic suturing skills: construct and concurrent validity.

BACKGROUND: The assessment of technical skills should provide objective feedback and judge suitability of progress during training. The aim of this study was to validate two objective assessment techniques for laparoscopic suturing and demonstrate a correlation between them. METHODS: Six experts, seven surgeons skilled in laparoscopic suturing, and 13 with no laparoscopic suturing skills were asked to place two or three intracorporeal sutures on a synthetic suture pad. The latter group was given video-based instructions prior to the execution of the sutures. Ergonomic conditions were standardized for all subjects. The procedures were recorded on videotape and two blinded observers rated the first suture of each subject on a 29-point checklist. A motion analysis system, Imperial College Surgical Assessment Device, was used to assess psychomotor skills. RESULTS: There was a significant difference in the time taken (p = 0.000) and total path length (p = 0.000) per suture across the groups. There were also a significant difference in the total checklist score (p = 0.000) and its individual categories. The was a strong correlation between the total path length and the total checklist score (coefficient, 0.78; p < 0.001). CONCLUSIONS: A combination of the motion analysis system and the checklist would make the process of formative feedback during the learning of intracorporeal suturing objective and comprehensive.

Clinical Competence↗

Milwaukee Prehospital Chest Pain Project--phase I: feasibility and accuracy of prehospital thrombolytic candidate selection.

This study prospectively determined the feasibility and accuracy of prehospital thrombolytic therapy candidate selection by base station emergency physicians. During a 6-month period, paramedics acquired and transmitted prehospital 12-lead electrocardiograms (ECGs) and then applied a thrombolytic therapy contraindication checklist. Emergency physicians interpreted prehospital ECGs and prospectively selected candidates for thrombolytic therapy. A safety committee of cardiologists reviewed prehospital ECGs, checklists and hospital records to determine accuracy independently. Six hundred-eighty stable adult prehospital patients with a chief complaint of nontraumatic chest pain were initially evaluated. Two hundred forty-one patients were excluded because of (1) unsuccessful electrocardiographic transmission (149), (2) transport to nonparticipating facilities (72), and (3) unavailable medical records (20). No prehospital thrombolytic therapy was administered in this study. Of 439 cases, 91 (21%) had the final diagnosis of acute myocardial infarction, 38 (8.7%) had diagnostic prehospital ECGs, and 12 (2.7%) were selected by emergency physicians as candidates for thrombolytic therapy. Seventy percent of patients with myocardial infarction had checklist exclusions for thrombolytic therapy. Prehospital evaluation increased mean scene time (paramedic arrival on scene to scene departure) by 4 minutes. The median time from chest pain onset to paramedic arrival in patients with myocardial infarction was 60 minutes. The estimated average time saved if prehospital thrombolytic therapy had been available was 101 +/- 81 minutes. The safety committee concluded that acceptable accuracy of emergency physician prehospital electrocardiographic interpretation, checklist and case selection was achieved. It is concluded that emergency physicians can accurately identify candidates for prehospital thrombolytic therapy.

Adult↗

Assessing the enduring residual neuropsychological effects of head trauma in college athletes who participate in contact sports.

The present study examined the enduring residual neuropsychological effects of head trauma in college athletes using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Postconcussion Syndrome Checklist, and the Stroop task. Based on a brief self-report concussion history survey, male and female athletes who participated in ice hockey, field hockey, lacrosse, and/or soccer were assigned to one of three concussion-history conditions: Non-concussed, Non-recent concussed (i.e., more than 2 years since last concussion), or Recent concussed (i.e., 2 years or less since last concussion). A fourth group of subjects consisting of non-concussed/non-athletes served in the control condition. Group differences emerged on the RBANS when immediate memory, delayed memory, and total scores were analyzed. Specifically, recent concussed athletes and, surprisingly, non-concussed athletes scored lower than control subjects in the two memory domains, whereas all three athlete groups had lower total RBANS scores than those of control subjects. Moreover, recent concussed athletes not only had lower immediate memory scores than control subjects, but also were impaired relative to non-recent concussed athlete subjects in this memory domain. No group differences were detected on the Stroop task or on the Postconcussion Syndrome Checklist. Interestingly, however, the severity of the Postconcussion Syndrome Checklist scores for the two athlete-concussed groups, taken in aggregate, correlated negatively with RBANS scores for attention (r = -.65) and delayed memory (r = -.61), and with the total RBANS score (r = -.59). In recent concussed athletes, lower delayed memory scores correlated with more severe Postconcussion Symptom Checklist scores (r = -.90), while more severe/higher number of concussions correlated with increased processing speed on the Stroop interference task (r = .90). These findings indicate that recent head injury produces alterations in neuropsychological function, especially that of memory, that resolve with time. More provocatively, the data also suggest that participation in contact sports may produce sub-clinical cognitive impairments in the absence of a diagnosable concussion presumably resulting from the cumulative consequences produced by multiple mild head trauma.

Adult↗

A global assessment tool for evaluation of intraoperative laparoscopic skills.

BACKGROUND: There is a pressing need for an intraoperative assessment tool that meets high standards of reliability and validity to use as an outcome measure for different training strategies. The aim of this study was to develop a tool specific for laparoscopic skills and to evaluate its reliability and validity. METHODS: The Global Operative Assessment of Laparoscopic Skills (GOALS) consists of a 5-item global rating scale. A 10-item checklist and 2 visual analogue scales (VAS) for competence and case difficulty were also used. During laparoscopic cholecystectomy, 21 participants were evaluated by the attending surgeon, by 2 trained observers and by self-assessment while dissecting the gallbladder from the liver bed. RESULTS: The intraclass correlation coefficient (ICC) for the total GOALS score was .89 (95% confidence interval [CI] .74 to .95) between observers, .82 (95% CI .67 to .92) between observers and attending surgeons, and .70 (95% CI .37 to .87) between participants and attending surgeons. The ICCs (observers) for the VAS (competence) and the checklist were .69 and .70, respectively. The mean total GOALS score (observers) for novices (postgraduate years [PGYs] 1 through 3) was 13 (95% CI 10.3 to 15.7) compared with 19.4 (95% CI 17.2 to 21.5) for experienced (PGY 4 through attending surgeons, P = .0006). The VAS demonstrated a difference in scores between novice and experienced participants (P = .001); however, the task checklist did not (P = .09). CONCLUSIONS: These data indicate that GOALS is feasible, reliable, and valid. They also suggest that it is superior to the task checklist and VAS for evaluation of technical skill by experienced raters. The findings support the use of GOALS in the training and evaluation of laparoscopic skills.

Clinical Competence↗

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

AIM: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the general isability of its results. METHODS: The standards for reporting of diagnostic accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a 2 day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

A novel approach to endourological training: training at the Surgical Skills Center.

PURPOSE: We investigated the effects of didactic teaching and supervised hands-on practice on endourological skills using high fidelity genitourinary bench models at a surgical skills laboratory. We also validated a global rating scale and checklist designed specifically for endourological tasks. MATERIALS AND METHODS: We assessed 17 urology residents for the ability to remove a mid ureteral stone using a high fidelity genitourinary model on 3 occasions, including a pre-test at the beginning of the study to assess baseline skills, after a didactic teaching session and after a supervised practice session on high fidelity models. Performance was graded according to a global rating scale, checklist, pass rating and time needed to complete task. RESULTS: Senior residents achieved significantly higher pre-test global rating scores than junior residents (p <0.01). One-way repeated measures analysis of variance revealed a significant effect of training on the endoscopic global rating score (p <0.001). Post-hoc tests demonstrated significant improvement in the global rating scores from the pre-test to the post-didactic session (p <0.05) and from the post-didactic to the post-practice session (p <0.01). Interrater reliability using the global rating scale was high (Pearson's r = 0.82, p <0.01). Significant but less powerful results were observed in the checklist score, pass rating and time. CONCLUSIONS: There was a positive effect of training at the surgical skills laboratory on endourological skills. The global rating scale showed good construct validity and reliability for assessing endourological tasks, more so than the checklist, pass rating or time.

Adult↗

Development of an objective structured assessment of technical skills for obstetric and gynecology residents.

OBJECTIVE: To develop an objective structured assessment for evaluating surgical skills of obstetrics and gynecology residents and to evaluate the reliability and validity of the assessment. METHODS: A seven-station, objective, structured assessment of technical skills was administered to 24 residents. The test included laparoscopic procedures (port placement, salpingostomy, suturing, vessel ligation) and open abdominal procedures (hypogastric ligation, repair of enterotomy, salpingo-oophorectomy.) All surgical tasks were done on pigs. Residents were timed and assessed at each station using three methods of scoring, a task-specific checklist, global rating scale, and pass-fail grade. RESULTS: Assessment of construct validity (the ability of the test to discriminate among residency levels) found significant differences on the checklist and the global rating scale by residency level. Reliability indices calculated with Cronbach's alpha were 0.89 for the global rating scale and 0.89-0.95 for the individual skills checklists. Interrater reliability was 0.87 for the global rating scale and 0.78-0.98 for the checklists. CONCLUSION: Objective, structured assessment of technical skills can assess residents' surgical skills with high reliability and validity. These assessments have possible application for identifying residents who need additional training and might provide a mechanism to ensure competence of surgical skills.

Adult↗

Development of a bench station objective structured assessment of technical skills.

OBJECTIVE: We have previously shown that objective structured assessment of technical skills performed in an animal model was an innovative, reliable, and valid method of assessing surgical skills. Our goal was to develop a less costly bench station objective structured assessment of technical skills and to evaluate the feasibility, reliability, and validity of this exam. METHODS: A seven-station examination was administered to 24 residents. The tests included laparoscopic procedures (salpingostomy, intracorporeal knot tying, closure of port sites) and open abdominal procedures (subcuticular closure, bladder neck suspension, repair of enterotomy, abdominal wall closure). All tasks were performed using life-like surgical models. Residents were timed and assessed at each station using three methods of scoring: a task-specific checklist, a global rating scale, and a pass/fail grade. RESULTS: Assessment of construct validity, the ability of the test to discriminate among residency levels, found significant differences on the checklist, global rating scale, time for procedures, and pass/fail grade by level of training. Reliability indices calculated with Cronbach's alpha were 0.77 for the checklists and 0.94 for the global rating scale. Overall interrater reliability indices were 0.91 for the global rating scale and 0.92 for the checklists. Total cost for replaceable parts and facilities was $1900. CONCLUSION: The less costly and more portable bench station objective structured assessment of technical skills can reliably and validly assess the surgical skills of gynecology residents. This type of examination can be a useful tool to identify residents who need additional surgical instruction, provide remediation, and may become a mechanism to certify surgical skill competence.

Adult↗

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. FINDINGS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

Authorship↗

Adolescents at risk for mistreating their children. Part I: Prenatal identification.

OBJECTIVE: To determine if the Family Stress Checklist helps prenatal care providers identify adolescents who are at risk for mistreating their children. METHODS: We studied 262 participants in a comprehensive, adolescent-oriented maternity program. During the prenatal period, the Family Stress Checklist was used to quantify abuse potential, with scores >25 defining high risk. Information about the social context of the pregnancy and the pattern of health care utilization was obtained with a self-administered questionnaire, and by reviewing the medical records. Major disruption of primary care giving by the adolescent mother was classified hierarchically as abuse, neglect, and abandonment. RESULTS: Family Stress Checklist scores ranged from 0 to 65 (mean + SD = 20.1 + 1.4); 113 (43%) of the 262 teenagers were classified as high risk. High and low risk adolescent mothers made an equivalent number of health maintenance and Emergency Department visits, but the high risk group initiated significantly more acute care visits (6.0 + 4.1 compared to 3.9 + 3.3; p < .0001). After controlling for pre-existing sociodemographic differences, high risk 1-year-olds were 8.41 (95% CI: 1.77-40.01) times and high risk 2-year-olds 5.19 (95% CI: 1.99-13.60) times more likely to have been mistreated than their low risk counterparts. CONCLUSIONS: Prenatal care providers can use the Family Stress Checklist to systematically identify a subgroup of adolescent mother whose excessive use of the acute medical care services and propensity for mistreating their children suggests the need for additional support services.

Adolescent↗

Child report of treatment issue resolution: pilot of a rapid assessment instrument.

The goals of this project concerned the construction and pilot of a rapid assessment self-report measurement tool to be used with child and adolescent sexual abuse victims to ascertain the effectiveness of psychotherapeutic intervention. One hundred and three 10 to 17-year-old girls who had been the targets of intrafamilial child sexual abuse (incest) participated in the research. Child and adolescent participants completed the draft instrument, the Child Report of Treatment Issue Resolution, as well as the Trauma Symptom Checklist for Children and the Children's Social Desirability Questionnaire. The research participants caretakers completed the Achenbach Child Behavior Checklist and a background questionnaire. Reliability of the study instrument was found to be 94. Content validity was quantified through a process of expert ratings of individual item relevance. Criterion and construct validity are supported by a substantial correlation between the study instrument and the Trauma Symptom Checklist for Children (-.74) and a moderate correlation between the study instrument and the Child Behavior Checklist for Children (-.40). The correlation between the study instrument and the Children's Social Desirability Questionnaire (.45) did not provide evidence of discriminate validity.

Adolescent↗

Examining the validity and reliability of childhood abuse scales: putting The Courage To Heal to the test.

OBJECTIVE: The main purpose of the current study was to examine the validity and reliability of The Courage To Heal Workbook checklist (Davis, 1990) in part, through examining the internal consistency and studying whether the CTHC distinguished between the participants reporting sexual abuse histories and those who did not. METHOD: Two hundred and seventy-nine college students were surveyed utilizing the symptom checklist from the Courage to Heal Workbook, Trauma Symptom Checklist-40 (TSC-40), Abusive Behavior Inventory (ABI), and questions related to participants' beliefs that they had been abused as a child. RESULTS: Results indicated that the Courage to Heal Checklist (CTHC) has robust reliability (alpha = .97) and can significantly discriminate between reported abuse survivors and nonsurvivors. Fifty-five percent of those participants reporting sexual abuse, 47% of those reporting physical abuse, and 34% of those reporting emotional abuse indicated a period of time during which they did not remember the abuse. CONCLUSION: Results indicate that the CTHC reliably differentiated between participants reporting past sexual abuse and those who did not. Mounting evidence continues to support that adult symptom profiles are able to indicate that some form of trauma is likely to have occurred in the past; however, differentiating between types of abuse based on symptom profiles may be impossible.

Adolescent↗

The standard of reporting of health-related quality of life in clinical cancer trials.

UNLABELLED: The standard of reporting of randomized controlled trials (RCTs) is important to the interpretation of outcomes such as health-related quality of life (HRQL). HRQL is used increasingly as an outcome in clinical cancer trials. DESIGN: All 1997 issues of 36 selected journals were hand searched to identify original articles that included the term "quality of life" in the title, abstract, keywords or methods. Studies were included if they were RCTs and addressed cancer-related topics. A checklist to assess the adequacy of reporting of HRQL was developed based on a guideline previously published by an expert panel. Two unblinded reviewers applied the quality of life reporting (QLR) and CONSORT checklists, along with an instrument to assess the likelihood of bias to each selected RCT. RESULTS: 72 articles were identified of which 20 were RCTs and cancer-related. For these 20 reports the median number of items in the QLR checklist that were adequately reported is 42% (range 15% to 85%). The median number of items in the CONSORT checklist that were adequately reported is 70% (range 47% to 95%). The mean score for the instrument to assess the likelihood for bias is 2.6 (95% CI 2. 08-3.12). CONCLUSIONS: The current standard of reporting of HRQL needs to be improved. Major deficiencies that should be addressed are failure to provide a rationale for HRQL assessment and inadequate description of methodology. Development and application of structured formats for presentation of HRQL may help to improve the standard of reporting of HRQL in the literature.

Guidelines as Topic↗