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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 (Consolidated Standards of Reporting Trials) 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 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.

Humans↗

Competency assessment for radiology.

Two important changes in the past year have addressed the need for ongoing assessment and training of radiologic technologists. Those changes are mandatory continuing education for ARRT-registered technologists and the JCAHO's requirement to assure staff competency. To prepare for a JCAHO inspection, supervisors at Pennsylvania Hospital developed competency checklists for orientation and annual performance appraisals. The checklists included job-specific skills in two areas: equipment and protocols. Sample checklists are reprinted in this article. They cover representative jobs in different areas of radiology: support staff, diagnostic radiology, radiation oncology, computed tomography and nuclear medicine.

Clinical Protocols↗

PPO fiduciary responsibility.

This article will be frustrating for you. It warns you of comprehensive legal liability--but does not give you step-by-step guidance or checklists. Why? Because there are practically no examples or specifics or checklists in the Employee Retirement Income Security Act of 1974 (ERISA), especially for fiduciary duty and the new "knowing participant" fiduciary duty which applies to PPOs. Other than a relative handful of official Prohibited Transaction Exemptions (PTEs), everything is judged on a case-by-case basis. Even Department of Labor Opinion articles are merely that--opinions written with lots of caveats and not considered legal precedents. In defense of the Department of Labor, the slightest difference in circumstance can trigger a totally opposite ruling, so their hesitancy to give simple checklists is understandable. This article also takes a conservative approach. Enforcement of ERISA fiduciary duty has been sporadic. However, this article is important to you and timely. In recent years, the Department of Labor has devoted at least 50 percent of its employee review with criminal penalties of benefits cases deemed to be fraud, waste, or abuse. It is important to remember that the Department of Labor will judge your actions with 20/20 hindsight. Thus, it is important not only to have good intentions, but also to be sure that it looks like you have taken the most prudent action when all is said and done--even if the action defies common sense or normal business practices.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗

Examining the symptom experience of hospitalized patients using a pen-based computer.

The purposes of this study were to test the feasibility of using a pen-based computer to capture self-reported symptom data, to evaluate the system, and to evaluate the importance of obtaining symptom data. The sample included 72 patients who were hospitalized for a variety of medical conditions. Self-reported symptom data was obtained with the automated Sign and Symptom Checklist. The feasibility of using an automated symptom checklist to capture self-reported symptom data was demonstrated. Patients' evaluations of the ease of use and the format of the system were primarily positive; mean ratings ranged from 4.58 to 4.70 on a 5-point scale. Patients indicated the importance of documenting symptoms, with a few suggesting that the use of an automated symptom checklist may increase communication between providers and patients. Study findings support the inclusion of self-reported symptom data in electronic health records and national health care databases.

Attitude to Computers↗

[Psychological health at school entrance].

INTRODUCTION: The rate of psychiatric disorders in childhood and adolescence was investigated in numerous studies and was found to be between 10% and 18%, boys having more problems to tackle than girls. These studies often concern school-age children, but it is sure that psychiatric disorders already occur in early childhood. In the present study, mental health was assessed in children of Jena, who were starting with school. A comparison with methodologically similar studies in Heidelberg and Cologne was possible. METHODS: The study was conducted in cooperation with the health department of Jena. Parents had to fill in the CBCL (Child Behaviour Checklist), which assesses behavioural disturbances and social competence. Participation was voluntary and anonymous. RESULTS AND DISCUSSION: From the total population of 1039 children 749 (72.0%) checklists were filled in by the parents. 674 (64.9%) checklists were completely filled in and included in the study. 86 out of 674 (64.9%) of the children had a psychiatric disorder, boys (13.4%) more often than girls (12.2%), especially in the scales "Externalizing disorders", "delinquent behaviour", "aggressive behaviour" and "attention deficit disorders". Children coming from certain areas (Lobeda, Winzerla) had not have more disturbances than children from the central part of the city. Only 8.1% of the parents of children with psychiatric disorders recognise such problems, and only 16.3% of these children had a visit with a physician or psychologist within the last year. This leads to the conclusion, that the sensitivity for psychiatric disorders of children must be improved.

Child↗

[The use of brief questionnaire in the diagnosis of attention deficit. Study group of the Manizales University Foundation].

INTRODUCTION: American Psychiatric Association has defined the DSM-IV ADD diagnostic criteria and symptoms, however, there is not a quantitative instrument to evaluate them in Spanish speaker population. OBJECTIVE: To evaluate the utility of a ADD checklist in a Colombian schooling population. PATIENTS AND METHODS: A randomized and stratified by sex, age and socioeconomic level, 4 to 17-year old, sample of 540 schooling subjects was selected from Manizales City, Colombia. An ADD checklist was applied to the parents of these subjects. RESULTS: The reliability of the different dimensions of the questionnaire (18 total items, 9 items for inattention, 9 for hyperactivity-impulsivity, and 6 for hyperactivity) were strong in both sex and in all age groups (Cronbach's alpha coefficient 0.71-0.92). Only the impulsivity dimension formed by three variables showed fairly weak reliability (0.42-0.79 Cronbach's alpha). Some factorial analysis found two dimensions. In the male sample first dimension (inattention) explain around the 45% of the variance, and the second dimension (hyperactivity-impulsivity) explain around the 12 to 15% of the variance in the different age groups. In the female sample the first dimension was hyperactivity-impulsivity and the second dimension was inattention. A categorical (yes or not) scored questionnaire found a ADD estimated prevalence of 16.1, distributed in type I (combined) 3.3%, in type II (inattentive) 4.3%, and type III (hyperactive-impulsive) 8.5%. Male prevalence was 19.8% and female 12.4%. CONCLUSIONS: ADD checklist Spanish version showed a strong reliability. A bidimensional stable structured was found. A clinical related ADD prevalence was presented, it was much higher than the prevalence of the developed countries.

Adolescent↗

Utility assessment for different clinical phases of breast cancer in Taiwan.

BACKGROUND AND PURPOSE: Utility is an important index of health-related quality of life (HRQoL). The purpose of this study was to assess utility in different clinical phases of breast cancer in patients in Taiwan. METHODS: Based on a review of HRQoL literature pertaining to breast cancer and medical records of 979 breast cancer patients admitted to National Taiwan University Hospital from 1991 to 1995, a semi-open checklist describing the diagnosis and treatment activities and impacts of different clinical phases of breast cancer was constructed. The checklist was then reviewed and revised in consultation with surgeons, medical oncologists, radiation oncologists, nurses, and breast cancer patients. Thirty-one clinical and public health experts were invited to assess the utility of each phase with the visual analog scale (VAS), standard gamble (SG), and time trade-off (TTO) methods, according to the description of the average patient's life in the checklist. The Delphi technique was used to reach expert consensus. RESULTS: The VAS utility scores were highest during screening phases (100 or 90), lower in phases of incidental finding of a tumor (75) and diagnosis (70), and lower still in the initial treatment phases, especially during adjuvant chemotherapy (50). The scores improved during the follow-up phases. There was a higher score for breast-conserving surgery (65) than modified radical mastectomy (60) only in the early follow-up phase. The scores for recurrence or metastasis (30) and terminal stage were considerably lower and reached the lowest level (10 in a general ward and 12.5 at home or in a hospice) among all phases. The utility scores assessed by SG and TTO were higher than those assessed by VAS. CONCLUSIONS: In this study, we established a consensus among clinical and public health experts on the impact of different clinical phases of breast cancer on utility. The results of this study may be useful in cross-cultural comparisons and cost-utility analyses for breast cancer.

Adult↗

Business Associate Agreements Inventory.

This Business Associate Agreement Inventory is a checklist for use by covered entities who use or disclose individually identifiable health information with or to their Business Associates. The checklist is designed to assist the covered entities to review their contracts with each respective Business Associate and determine whether the contracts contain all of the provisions required by the Health Insurance Portability and Accountability Act regulations. The regulations addressed in the checklist include the Transactions and Code Sets Standards (effective October 16, 2000), the proposed Security Standards, and the final Privacy Regulations (published December 28, 2000).

Commerce↗

An application of the situational interview to selection of nursing personnel.

The study was designed to develop a situational interview technique to replace the unstructured interview commonly used in the selection process of nursing personnel and explore the applicability of incorporating the situational interview and psychological tests into the development of a regression model of nursing personnel selection. The authors collected from several teaching hospitals in Kaohsiung job-related critical incidents which were used to construct the questionnaire for the situational interview and the performance appraisal checklist. A sample of subjects, 198 in the first year but only 116 the second year, were interviewed and evaluated with the situational interview, the Nursing Image Scale, the Work Values Inventory, and part of the Gordon Personal Profile-Inventory as predictor measures and the performance appraisal checklist as the criterion measure. The results showed that the reliability and validity coefficients of the situational interview were close to or even better than those obtained by the previous researchers in the same field. The reliability and validity coefficients of the performance appraisal checklist indicated its applicability and suitability. Multiple regression analysis indicated that the situational interview as well as some traits measured by the personality and values tests could predict the performance appraisal scores of nursing personnel.

Adult↗

[Effectiveness of a clinical test in the preselection of children with suspected fragile X syndrome].

BACKGROUND: Fragile X syndrome (FXS) is the most frequent hereditary cause of mental retardation. It can be diagnosed by molecular genetic techniques, but clinical suspicion is made less likely by it variable expression. OBJECTIVE: To assess the effectiveness of a six-item checklist in the preselection of children who are candidates for FXS genetic study. MATERIAL AND METHODS: We studied 70 male patients aged between 2 and 10 years with mental retardation of unknown cause. In all patients a checklist with six clinical criteria (mental retardation, history of familial mental retardation, long face, large ears, autistic-like behaviour, and attention deficit disorder with hyperactivity) measured from 0-2 points was applied and molecular genetic studies using polymerase chain reaction and Southern-blot were performed. RESULTS: In 14 of the 70 children (20%) molecular study confirmed full mutation (200 CGG repeats). A score of six points in the test had the greatest discriminatory power and was reached by 14 patients (100%) with mutation, but only by 2of 56patients (3.5%) without mutation. The most accurate diagnostic model was the association of mental retardation, attention deficit disorder with hyperactivity, large ears and a history of familial mental retardation followed by long face and autistic-like behaviour. CONCLUSIONS: The six-item checklist improved the preselection of children with suspicion of FXS, which was later confirmed by molecular genetic techniques.

Child↗

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

To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here 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 this 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 shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done 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.

Humans↗

Follow-up of children attending infant language units: outcomes at 11 years of age.

A large cohort of 242 children who had been attending infants language units at 7 years of age was followed up when the children were in their final year of primary school. Two hundred (83%) of the children were reassessed at 11 years of age on a wide battery of language and literacy measures, on a test of non-verbal ability, an autism checklist and a communication checklist. In total, 89% of children still scored < 1 SD from the mean on at least one test of language and the majority (63%) scored poorly on three or more assessments demonstrating widespread difficulties. Compared with non-verbal abilities at 7 years of age, a large proportion of the cohort also performed poorly on performance IQ subtests (28%). A further 10 children scored highly on a checklist for autistic spectrum disorder. Thus, only 115 (58%) children could be said to meet criteria for specific language impairment. A small group of 16 children appeared to have entirely resolved their difficulties. These outcomes and their implications for education and long-term impact of the disorder are discussed.

Autistic Disorder↗

Family medicine clerkship web sites: the state of the art.

BACKGROUND AND OBJECTIVES: The use of on-line syllabi to acquire information about a course, clerkship, or rotation is growing. This study investigated the number of existing family medicine clerkship Web sites with syllabi and determined their completeness and usability. METHODS: In sping 1999, all schools with third-year family medicine clerkship Web sites were identified (n = 71) using Association of American Medical Colleges and American Academy of Family Physicians clerkship directories to identify required family medicine clerkships, followed by a Web search to identify any associated Web sites. A checklist with 11 content and 5 technical categories was developed and pilot tested. All sites were evaluated by at least two investigators. Two identifiable checklist characteristics were required to be present for a site to be identified as an on-line syllabus and included in the study. RESULTS: Of the 71 sites initially identified, 40 were included in the study, 22 were excluded, and 9 required further review by an additional evaluator. A total of 44 sites were included in the study. The most common content features identified were instructor information, goals, overview, and requirements. Less-common features included objectives, learning resources, schedule, and grading policy. CONCLUSIONS: A minority of family medicine clerkships have on-line syllabi. Most sites have basic information, but other relevant clerkship information is absent. New and revised family medicine clerkship on-line syllabus development would benefit from using the checklist to guide the creation of instructionally sound educational resources.

Clinical Clerkship↗

Base rate and simulated symptoms of mild head injury among normals.

This study examined the vulnerability of several self-report instruments commonly used in neuropsychological evaluation - the Iowa Interview for Partial Seiwre-Like Symptoms, Postconcussion Checklist (PCL). Postconcussion Syndrome Checklist (PCSC), and Beck Depression Inventory (BDI) - to exaggerated or feigned complaints. Two hundred twenty-nine college student volunteers completed the instruments under one of three conditions: I) Base Rate/Control; simulated Head Injured, but 2) without or 3) with prospect of financial gain for the injury. Although the simulated Head Injured groups did not differ significantly from one another, both groups endorsed more symptoms than the Base Rate group, suggesting that the instruments are vulnerable, to simulation. Base rates of head injury symptoms in the normal population, laypersons' knowledge about the sequelae of mild head injury, and implications of using symptom checklists in medicolegal evaluations were discussed, as was the desirability of replicating this study with noncollege student populations.

Journal Article↗

The structure of medical competence and results of an OSCE.

BACKGROUND: Medical competence is a central concept in medical education. Educational efforts in medical training are directed at the achievement of a maximal medical competence. The concept of the structure of medical competence (multidimensional or one-dimensional with strongly interrelated competences) therefore affects the educational developments and assessment procedures. PURPOSE: To examine the applicability of a one or more dimensional character of medical competence in student assessments, by analysing the results of 356 students in the history taking station of an objective structured clinical examination (OSCE), in relation to other assessment procedures. METHODS: The performances of 356 students in a history taking station of an OSCE were analysed. Analyses of the checklist scores were aimed at the dimensionality of history taking skills. External criteria were used to test the validity of the scores on the checklist. RESULTS: The analyses of the scores on the history taking checklist indicated at least five dimensions of history taking skills: the frequency of patient-centred skills, the quality of performance of patient-centred skills, complaint-oriented skills, general social skills, and the provision of procedural information. CONCLUSION: Medical competence, as a subject of assessment, can be seen as a multifaceted construct. This study shows that history taking alone might be composed of five different dimensions, suggesting that medical competence in respect of assessment might be viewed as a multifaceted construct which in that sense has implications for the assessment of medical competence.

Competency-Based Education↗

[Indicators as the basis for quality-control in the midwifery practice].

A study on the quality of primary obstetric care in uncomplicated pregnancies carried out by means of a checklist revealed substandard factors in perinatal care in 71 out of 72 pregnancies. However there are many objections to the quality-control procedure. Some items on the original checklist had to be abandoned due to lack of evidence. In other items definitions and circumstances had not been properly considered and in some cases the patient's own wishes were responsible for a change in policy. The quality of the care delivered cannot be judged only by counting items on a checklist, but requires careful consideration of the situation and of the circumstances that led to the choices in perinatal care.

Female↗

Identification of the most common problems by patients with ankylosing spondylitis using the international classification of functioning, disability and health.

OBJECTIVE: The International Classification of Functioning, Disability and Health (ICF) aims to classify functioning and health by a number of categories divided over 3 components: body functions and body structures, participation and activities, and environmental factors. We identified the common health problems of patients with ankylosing spondylitis (AS) based on the ICF from the perspective of the patient. METHODS: During structured interviews with the extended ICF checklist, trained assessors collected data from 111 patients with AS. ICF categories identified by more than 5% of the patients as at least mildly impaired or restricted were selected. Categories identified by less than 5% were removed. Additional impairments/restrictions reported by more than 5% of the patients, after the structured interviews and not yet included in the checklist, were added. RESULTS: One hundred nineteen (72%) out of 165 categories of the extended ICF checklist were identified to be at least mildly impaired or restricted. Within each of the 4 components of the ICF, at least one-third of the categories were impaired or restricted for more than 50% of the patients. Thirty-nine (33%) categories were related to movement and mobility. Within the component "environmental factors" the categories "support of immediate family" and "health professionals" were the most important facilitators, "climate" was the most important barrier. Eight impairments were additionally mentioned as relevant. These were hierarchically lower levels of ICF categories previously included and they were added. CONCLUSION: One hundred twenty-seven ICF categories represent the comprehensive classification of functioning in AS from the patients' perspective. The results underscore the need to address the 4 ICF components when classifying functioning and to emphasize that functioning implies more than physical functioning.

Activities of Daily Living↗

An approach to nutrition screening for older Americans.

The Nutrition Screening Initiative suggests an adaptable, tiered approach to screening for poor nutritional status in older Americans. The first level of screening is a checklist to be completed by elderly individuals or their caregivers. This checklist, which will be widely disseminated, describes the warning signs of poor nutritional status. It is anticipated that individuals will approach their physicians on the basis of scores on this checklist. Also included are two screening tests designed to help clinicians more easily detect poor nutritional status, or risk factors for poor nutrition, in their patients. The level I screen is to be completed by a social service or health care professional, or by other trained personnel. The level II screen focuses on additional information to be obtained following referral to a physician or other qualified health care professional.

Aged↗