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PubMed2003

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

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study and to evaluate its generalisability. 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 two-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 regarding 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 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, 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↗
PubMed1998

Hunger in children in the United States: potential behavioral and emotional correlates.

OBJECTIVE: Results from a recent series of surveys from 9 states and the District of Columbia by the Community Childhood Hunger Identification Project (CCHIP) provide an estimate that 4 million American children experience prolonged periodic food insufficiency and hunger each year, 8% of the children under the age of 12 in this country. The same studies show that an additional 10 million children are at risk for hunger. The current study examined the relationship between hunger as defined by the CCHIP measure (food insufficiency attributable to constrained resources) and variables reflecting the psychosocial functioning of low-income, school-aged children. METHODS: The study group included 328 parents and children from a CCHIP study of families with at least 1 child under the age of 12 years living in the city of Pittsburgh and the surrounding Allegheny County. A two-stage area probability sampling design with standard cluster techniques was used. All parents whose child was between the ages of 6 and 12 years at the time of interview were asked to complete a Pediatric Symptom Checklist, a brief parent-report questionnaire that assesses children's emotional and behavioral symptoms. Hunger status was defined by parent responses to the standard 8 food-insufficiency questions from the CCHIP survey that are used to classify households and children as "hungry," "at-risk for hunger," or "not hungry." RESULTS: In an area probability sample of low-income families, those defined as hungry on the CCHIP measure were significantly more likely to have clinical levels of psychosocial dysfunction on the Pediatric Symptom Checklist than children defined as at-risk for hunger or not hungry. Analysis of individual items and factor scores on the Pediatric Symptom Checklist showed that virtually all behavioral, emotional, and academic problems were more prevalent in hungry children, but that aggression and anxiety had the strongest degree of association with experiences of hunger. CONCLUSION: Children from families that report multiple experiences of food insufficiency and hunger are more likely to show behavioral, emotional, and academic problems on a standardized measure of psychosocial dysfunction than children from the same low-income communities whose families do not report experiences of hunger. Although causality cannot be determined from a cross-sectional design, the strength of these findings suggests the importance of greater awareness on the part of health care providers and public health officials of the role of food insufficiency and hunger in the lives of poor children.

Affective Symptoms↗
PubMed2004

Health-related quality of life in children and adolescents who have a diagnosis of attention-deficit/hyperactivity disorder.

OBJECTIVE: The aim of treatment for attention-deficit/hyperactivity disorder (ADHD) is to decrease symptoms, enhance functionality, and improve well-being for the child and his or her close contacts. However, the measurement of treatment response is often limited to measuring symptoms using behavior rating scales and checklists completed by teachers and parents. Because so much of the focus has been on symptom reduction, less is known about other possible health problems, which can be measured easily using health-related quality-of-life (HRQL) questionnaires, which are designed to gather information across a range of health domains. The aim of our study was to measure HRQL in a clinic-based sample of children who had a diagnosis of ADHD and consider the impact of 2 clinical factors, symptom severity and comorbidity, on HRQL. Our specific hypotheses were that parent-reported HRQL would be poorer in children with ADHD than in normative US and Australian pediatric samples, in children with increasing severity of ADHD symptoms, and in children who had diagnoses of comorbid psychiatric disorders. METHODS: Cross-sectional survey was conducted in British Columbia, Canada. The sample included 165 respondents of 259 eligible children (63.7% response rate) who were referred to the ADHD Clinic in British Columbia between November 2001 and October 2002. Children who are seen in this clinic come from all parts of the province and are diverse in terms of socioeconomic status and case mix. ADHD was diagnosed in 131 children, 68.7% of whom had a comorbid psychiatric disorder. Some children had >1 comorbidity: 23 had 2, 5 had 3, and 1 had 4. Fifty-one children had a comorbid learning disorder (LD), 45 had oppositional defiant disorder or conduct disorder (ODD/CD), and 27 had some other comorbid diagnosis. The mean age of children was 10 years (standard deviation: 2.8). Boys composed 80.9% (N = 106) of the sample. We used the 50-item parent version of the Child Health Questionnaire to measure physical and psychosocial health. Physical domains include the following: physical functioning (PF), role/social limitations as a result of physical health (RP), bodily pain/discomfort (BP), and general health perception (GH). Psychosocial domains include the following: role/social limitations as a result of emotional-behavioral problems (REB), self-esteem (SE), mental health (MH), general behavior (BE), emotional impact on parent (PTE), and time impact on parents (PTT). A separate domain measures limitations in family activities (FA). There is also a single-item measure of family cohesion (FC). Individual scale scores and summary scores for physical (PhS) and psychosocial health (PsS) can be computed. Symptom severity data (parent and teacher) came from the Child/Adolescent Symptom Inventory 4. These checklists provide information on symptoms for the 3 ADHD subtypes (inattentive, hyperactive, and combined). Each child underwent a comprehensive psychiatric assessment by 1 of 4 child psychiatrists. Documentation included a full 5-axis Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis on the basis of a comprehensive assessment. Clinical information for each child was extracted from hospital notes. RESULTS: Compared with both population samples, children with ADHD had comparable physical health but clinically important deficits in HRQL in all psychosocial domains, FA, FC, and PsS, with effect sizes as follows: FC = -0.66, SE = -0.90, MH = -0.97, PTT = -1.07, REB = -1.60, BE = -1.73, PTE = -1.87, FA = -1.95, and PsS = -1.98. Poorer HRQL for all domains of psychosocial health, FA, and PsS correlated significantly with more parent-reported inattentive, hyperactive, and combined symptoms of ADHD. Children with > or =2 comorbid disorders differed significantly from those with no comorbidity in most areas, including RP, GH, REB, BE, MH, SE, PTT, FA, and PsS, and from those with 1 comorbid disorder in 3 domains, including BE, MH, and FA and the PsS. The mean PsS score for children in the ODD/CD group (mean difference: -12.9; effect size = -1.11) and children in the other comorbidity group (-9.0; effect size = -.77) but not children in the LD group were significantly lower than children with no comorbid disorder. Predictors of physical health in a multiple regression model included child's gender (beta = .177) and number of comorbid conditions (beta = -.197). These 2 variables explained very little variation in the PhS. Predictors of psychosocial health included the number of comorbid conditions (beta = -.374) and parent-rated combined ADHD symptoms (beta = -.362). These 2 variables explained 31% of the variation in the PsS. CONCLUSIONS: Our study shows that ADHD has a significant impact on multiple domains of HRQL in children and adolescents. In support of our hypotheses, compared with normative data, children with ADHD had more parent-reported problems in terms of emotional-behavioral role function, behavior, mental health, and self-esteem. In addition, the problems of children with ADHD had a significant impact on the parents' emotional health and parents' time to meet their own needs, and they interfered with family activities and family cohesion. The differences that we found represent clinically important differences in HRQL. Our study adds new information about the HRQL of children with ADHD in relation to symptom severity and comorbidity. Children with more symptoms of ADHD had worse psychosocial HRQL. Children with multiple comorbid disorders had poorer psychosocial HRQL across a range of domains compared with children with none and 1 comorbid disorder. In addition, compared with children with no comorbidity, psychosocial HRQL was significantly lower in children with ODD/CD and children in the other comorbidity group but not in children with an LD. The demonstration of a differential impact of ADHD on health and well-being in relation to symptom severity and comorbidity has important implications for policies around eligibility for special educational and other supportive services. Because the impact of ADHD is not uniform, decisions about needed supports should incorporate a broader range of relevant indicators of outcome, including HRQL. Although many studies focus on measuring symptoms using rating scales and checklists, in our study, using a multidimensional questionnaire, we were able to show that many areas of health are affected in children with ADHD. We therefore argue that research studies of children with ADHD should include measurement of these broader domains of family impact and child health.

Adolescent↗
PubMed2006

Mirrored symptoms in mother and child with chronic fatigue syndrome.

OBJECTIVE: Our aim with this study was to assess the relation between chronic fatigue syndrome in adolescents and fatigue and associated symptoms in their fathers and mothers, more specifically the presence of chronic fatigue syndrome-like symptoms and psychologic distress. METHOD: In this cross-sectional study, 40 adolescents with chronic fatigue syndrome according to the Centers for Disease Control and Prevention criteria were compared with 36 healthy control subjects and their respective parents. Questionnaires regarding fatigue (Checklist Individual Strength), fatigue-associated symptoms, and psychopathology (Symptom Checklist-90) were applied to the children and their parents. RESULTS: Psychologic distress in the mother corresponds with an adjusted odds ratio of 5.6 for the presence of CFS in the child. The presence of fatigue in the mother and dimensional assessment of fatigue with the Checklist Individual Strength revealed odds ratios of, respectively, 5.29 and 2.86 for the presence of chronic fatigue syndrome in the child. An increase of 1 SD of the hours spent by the working mother outside the home reduced the risk for chronic fatigue syndrome in their child with 61%. The fathers did not show any risk indicator for chronic fatigue syndrome in their child. CONCLUSIONS: Mothers of adolescents with chronic fatigue syndrome exhibit fatigue and psychologic symptoms similar to their child in contrast with the fathers. The striking difference between the absent association in fathers and the evident association in mothers suggests that the shared symptom complex of mother and child is the result of an interplay between genetic vulnerability and environmental factors.

Adolescent↗
PubMed2006

Severe fatigue in adolescents: a common phenomenon?

OBJECTIVE: The purpose of this study was to determine the prevalence of severe fatigue in adolescent boys and girls, to explore the role of lifestyle factors in fatigue, and to investigate whether severe fatigue in a healthy population is associated with depression, anxiety, and comorbid factors also observed in chronic fatigue syndrome patients. METHODS: In a sample of 1718 boys and 1749 girls, fatigue severity and duration were measured using a multidimensional questionnaire (Checklist Individual Strength). In addition, self-reports of depressive symptoms, anxiety, chronic fatigue syndrome-related symptoms, and lifestyle characteristics were assessed by means of questionnaires. Prevalence rates of severe fatigue and severe fatigue for > or =1 month, based on a clinical cutoff score of the Checklist Individual Strength, were determined for boys and girls separately, and gender-specific predictors of fatigue were identified by multiple regression analysis. RESULTS: The data showed high prevalence rates of severe fatigue in adolescents. Remarkable differences between boys and girls were observed: 20.5% of girls and 6.5% of the boys scored above the clinical cutoff score on the Checklist Individual Strength. Of these subjects 80.0% of the girls and 61.5% of the boys reported severe fatigue for > or =1 month. Of the examined lifestyle characteristics, only sleep characteristics and the participation in sports played a role in predicting fatigue in both genders. Moreover, in girls, fatigue was associated with higher age, an early menarche, medication use, and the absence of an additional job. Overall, girls scored higher on depression, anxiety, and chronic fatigue syndrome-related symptoms. However, the relation between fatigue and these comorbid symptoms did not differ between genders. In both girls and boys, the duration of fatigue was positively related to fatigue severity, severity of depression and anxiety, and the number of chronic fatigue syndrome-related symptoms. CONCLUSIONS: Fatigue prevalence among adolescents is high, especially in girls. Adolescent girls seem to be more vulnerable to symptoms of fatigue and comorbidity than boys. Interestingly, despite a female predominance in complaints, the relation between fatigue and depression, anxiety, and chronic fatigue syndrome-related symptoms was not gender specific and emerged as a cluster. In both genders, fatigue duration was associated with the severity of fatigue and the level of psychological comorbidity and chronic fatigue syndrome-related symptoms, and we, therefore, hypothesize that enduring severe fatigue may form a risk factor for the development of chronic fatigue syndrome.

Adolescent↗
PubMed2004

Linking better shiftwork arrangements with safety and health management systems.

OBJECTIVE: Various support measures useful for promoting joint change approaches to the improvement of both shiftworking arrangements and safety and health management systems were reviewed. A particular focus was placed on enterprise-level risk reduction measures linking working hours and management systems. METHODS: Voluntary industry-based guidelines on night and shift work for department stores and the chemical, automobile and electrical equipment industries were examined. Survey results that had led to the compilation of practicable measures to be included in these guidelines were also examined. The common support measures were then compared with ergonomic checkpoints for plant maintenance work involving irregular nightshifts. On the basis of this analysis, a new night and shift work checklist was designed. RESULTS: Both the guidelines and the plant maintenance work checkpoints were found to commonly cover multiple issues including work schedules and various job-related risks. This close link between shiftwork arrangements and risk management was important as shiftworkers in these industries considered teamwork and welfare services to be essential for managing risks associated with night and shift work. Four areas found suitable for participatory improvement by managers and workers were work schedules, ergonomic work tasks, work environment and training. The checklist designed to facilitate participatory change processes covered all these areas. CONCLUSIONS: The checklist developed to describe feasible workplace actions was suitable for integration with comprehensive safety and health management systems and offered valuable opportunities for improving working time arrangements and job content together.

Circadian Rhythm↗
PubMed1998

The effect of lead exposure on behavior problems in preschool children.

OBJECTIVES: Interpreting associations between lead exposure and child behavior problems is difficult because studies have not controlled for sociodemographic confounders or have used shed teeth to mark exposure. This study explored associations between blood lead and preschool behavior. METHODS: Children from a smelter town and a non-lead-exposed town in Yugoslavia were followed up prospectively from pregnancy through age 3. The Child Behavior Checklist was used to assess behavior problems in 379 3-year-olds, controlling for sociodemographic factors and difficult infant temperament. RESULTS: Multiple regression revealed the expected significant associations between checklist subscales and sociodemographic factors, which explained 7% to 18% of the variance on the subscales. Concurrent blood lead explained a significant 1% to 4% of the variance on the Destructive and Withdrawn subscales. Earlier difficult temperament explained an additional 2% to 5% of the checklist variance. Scores on the Destructive subscale were consistently associated with blood lead. As blood lead increased from 10 to 20 micrograms/dL, subscale scores increased by approximately 0.5 points. CONCLUSIONS: Lead/behavior associations are significant but small compared with the effects of social factors.

Air Pollutants, Occupational↗
PubMed1999

Structure of personality disorders from the perspective of the Revised Neo Personality Inventory domain scales and the Psychopathology-5 Scales.

This study tested the generality and comprehensiveness of the five-factor model of personality as applied to the Personality Adjective Checklist's (Strack, 1987) personality disorder scales. A sample of 258 undergraduates (113 men and 145 women) completed the Personality Adjective Checklist, the Revised NEO Personality Inventory, and the Psychopathology-5 Scales for partial course credit. A combined principal axis analysis with varimax rotation was performed for nonoverlapping scales of the Personality Adjective Checklist, the Revised NEO Personality Inventory domain scales and the Psychopathology-5 scales. The results indicated four factors which were identified as Neuroticism, Extraversion, Disagreebleness, and Conscientiousness. Openness did not emerge as a separate factor. These results supported the comprehensiveness but not the generality of the five-factor model as applied to personality disorders.

Adult↗
PubMed2003

Depression in inpatients: bipolar vs unipolar.

162 depressed inpatients were divided into three diagnostic groups to compare patterns of sociodemographic characteristics, psychopathology, and psychosocial: 35 had a single episode of major depression, 96 had recurrent major depression, and 31 had a bipolar disorder. Psychopathology and psychosocial functioning were measured by clinician-rated scales, Montgomery-Asberg Depression Rating Scale, Hamilton Rating Scale for Depression, Clinical Global Impression, and self-rating scales, Symptom Checklist-90, Social Support Questionnaire, Social Adjustment Scale. The three groups were comparable on sociodemographic variables, with the exception of education. Univariate analyses showed a similar social impairment as measured by Social Support Questionnaire, Social Adjustment Scale, and no significant differences were recorded for the psychopathology when the total test scores (Montgomery-Asberg Depression Rating Scale, Hamilton Rating Scale for Depression, Clinical Global Index, Symptom Checklist-90) were evaluated. Some differences emerged for single items in the Montgomery-Asberg Depression Rating Scale and Symptom Checklist-90. These findings suggest a substantial similarity among the three groups. Results are discussed in terms of the clinical similarities between unipolar and bipolar patients during a depressive episode as well as the limitations of cross-sectional study implies.

Adult↗
PubMedDate not supplied

The results of major clinical trials: critical assessment, the circulation of information and media coverage.

The round table elected to focus its discussion on trials that, in terms of their importance, are likely to modify medical practices and behaviour. Such trials may be pre- or postmarketing studies. For the findings of a trial to result in a change in practice, they must be credible and fulfil the basic methodological criteria. It is nonetheless appropriate to complete that binary assessment by the use of an assessment checklist appropriate to each category of users, i.e. the Regulatory Agency, prescribing physicians and patients, who are sometimes informed directly by the media. The members of the round table proposed the 'Giens 2003 checklist'. It consists of an interpretative semi-quantitative assessment checklist based on simple messages relevant to practice. Critical assessment is a necessary prelude to the circulation of the results to the various parties involved (healthcare professionals, patients, patient associations, the media and the general public) and the process of informing those parties in readily understandable but accurate terms. The practical implementation of the results, with a change in behaviour and/or the issuing of guidelines, are subsequent stages for which a certain lag time is inevitable. The assessment of implementation programmes, together with an accurate analysis of the obstacles to changing medical practice, should, in the future, improve and accelerate the implementation of important results in order to optimise patient management.

Clinical Trials as Topic↗
PubMed1987

Age and education effects in the diagnosis of attention deficit disorder, residual type in an alcoholic population.

Two self-report measures that have been used to screen an alcoholic population for Attention Deficit Disorder, Residual Type (ADD-RT) are the Childhood Symptom Checklist and a listing of the DSM-III criteria. Both measures have evidence supporting their validity as screening instruments for ADD-RT in alcoholics. This study further explores the properties of these instruments by determining whether the age or educational level of alcoholic patients relates to their performance on these measures. No differences were found between the scores of younger and older patients. However, alcoholic patients with more education had fewer DSM-III symptoms of ADD-RT, but did not have fewer symptoms on the Childhood Symptom Checklist. The difference in performance on these two previously consistent measures is noted. Future research might explore the possibility that the DSM-III symptoms of ADD-RT are more sensitive to functional deficits in adults than the Childhood Symptoms Checklist, which asks for symptoms of Attention Deficit Disorder as a child.

Adult↗
PubMed2004

What type of information do parents need after being discharged directly from the delivery ward?

Early discharge normally means that mother and infant are discharged from the hospital between six hours and three days after delivery. Early discharge with home-visits after normal delivery was introduced at Uppsala University Hospital in 1990. Seventeen percent of the women who gave birth in 2003 in Uppsala used the home-care option as an alternative to postnatal care at the hospital. The home-visiting midwives use a checklist to give and gain information about the health of the child and mother and about how breast-feeding is going. The purpose of this study was to examine the parents' need of information after early discharge after delivery and to compare their needs with the information given according to the checklist for home-visits. Forty-two couples completed the study. They were asked to formulate five questions to the midwife at the home-visit. After the questions were gathered, a content-analysis was done. Three different main groups were identified: questions concerning 1) the child (68%) such as hygiene, bowel movements, burping, vomiting, eating, sleeping and sneezing 2) breast-feeding (21%) questions were asked about position while breast-feeding, nipples and amount of milk 3) the mother (11%) questions concerned afterpains, stitches, eating and drinking. The results show that the checklist worked sufficiently well as a work tool, but can be adjusted further according to the parents' need. This study shows that they needed more information about the care of the infant, primarily concerning hygiene.

Breast Feeding↗
PubMed2006

Assessing explanatory models for common mental disorders.

OBJECTIVES: This article addresses the clinical implications of 3 questions: (1) Can a simple checklist, suitable for use by practitioners, assess all components of explanatory models (EMs) for mental distress? (2) Are perceived causes of mental distress actually related to treatment preferences? (3) Are EMs influenced uniquely by ethnic group, or are they more closely associated with the presence of common mental disorders? METHOD: From February 2003 to January 2004, we investigated EMs for mental distress among 79 Bangladeshi, 85 black Caribbean, and 97 white British people who reported difficulties in the preceding month. EMs were assessed by a self-report checklist that inquired about the identity, causes, timeline, consequences, controllability, and preferred treatments for mental distress. Common mental disorders were assessed using the Clinical Interview Schedule (revised). RESULTS: Independent of ethnic group, people with common mental disorders were more likely to give spiritual causal explanations (odds ratio [OR] = 3.1, 95% CI = 1.9 to 4.9), to report behavioral (OR = 2.2, 95% CI = 1.3 to 3.8) and financial consequences (OR = 3.3, 95% CI = 1.8 to 6), and to prefer complementary treatments (OR = 4.6, 95% CI = 2.3 to 9.1). Compared with black Caribbean and white British subjects, Bangladeshi subjects more often gave spiritual or physical causal explanations. Compared with white British subjects, Bangladeshi and black Caribbean subjects preferred medical and spiritual treatments, whereas white British subjects, as compared with the other 2 ethnic groups, preferred self-management and social treatments. Causal explanations did not always relate to the corresponding treatment preferences. CONCLUSIONS: EMs can be assessed by a simple checklist, show variations by ethnic group, and are associated with common mental disorders. Identifying EMs may strengthen the assessment of common mental disorders.

Adult↗
PubMedDate not supplied

Measuring cues for healthy choices on restaurant menus: development and testing of a measurement instrument.

PURPOSE: To develop and test the Menu Checklist, an instrument to be used by community members to assess cues for healthy choices in restaurants. DESIGN: Menus from 14 restaurants were coded independently by two trained community reviewers to test the interrater reliability of the instrument. SETTING: A low-income, urban, African-American community in Los Angeles, California. SUBJECTS: Restaurants were selected based on community perceptions of their potential to be included in a nutrition education and advocacy program to improve the availability of healthy foods. MEASURES: The Menu Checklist was adapted from previously tested measurement tools developed by the Prevention Research Center at Saint Louis University. Intraclass correlation coefficients (ICCs), kappa statistics, and percent agreements were calculated to assess interrater reliability. Descriptive statistics were calculated to show the availability of cues for healthy foods. RESULTS: The interrater reliability coefficients for the majority of items were high (.93-1.0). Labeling on restaurant menus was rare, as were low-fat choices. Fruits and vegetables were readily available: 31% of all entrees included one serving and 39% of all appetizers were primarily fruits and vegetables. CONCLUSIONS: The Menu Checklist is a reliable, low-cost means for community members to collect data on influences on food choices in restaurants.

Black or African American↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Con solidated S tandards o f R eporting T rials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Algorithms↗
PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.

BACKGROUND: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors. OBJECTIVE: 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 the study and to evaluate its generalizability. 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, methodologists and statisticians, and members of professional organizations 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 on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, 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 the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗
PubMed2004

Better reporting of harms in randomized trials: an extension of the CONSORT statement.

In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.

Evidence-Based Medicine↗
PubMed2006

Brief communication: Better ways to question patients about adverse medical events: a randomized, controlled trial.

BACKGROUND: There is no standard method of identifying adverse events in clinical trials. OBJECTIVE: To determine whether 3 different methods of questioning patients about adverse events in a clinical trial affect the frequency of reported events. DESIGN: Randomized, single-blind, controlled trial. SETTING: A Veterans Administration medical center, San Francisco, California. PARTICIPANTS: Men 50 years of age or older who had benign prostatic hyperplasia. MEASUREMENT: Frequency of self-reported medical problems. INTERVENTION: The authors randomly assigned 214 men who were undergoing a 1-month, single-blind, placebo run-in period during an existing clinical trial to 3 groups to test different self-administered methods of assessing medical problems at the end of the run-in period. The first group was asked an open-ended question; the second group was asked an open-ended, defined question; and the third group was given a checklist of 53 common side effects. RESULTS: All 214 patients completed the study. Patients assigned to the checklist group reported a total of 238 adverse events; in comparison, patients who were asked an open-ended question or an open-ended, defined question reported 11 and 14 adverse events, respectively (P < 0.001). The percentage of patients reporting any adverse event was also much higher in the group assigned to the checklist (77%) than in the first group (14%) or second group (13%) (P < 0.001). LIMITATIONS: The study included only relatively healthy, well-educated, middle-aged men and assessed only self-reported medical problems after the participants had taken placebo for 1 month. All personnel overseeing the study were aware of the group assignments. CONCLUSIONS: Different methods of collecting patient data regarding adverse events lead to large differences in the reported rates of adverse events in clinical trials, potentially reducing the validity of comparisons between the side effect profiles of drugs and other interventions.

Aged↗