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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 only be achieved 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 biasedestimates of treatment effect or 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, 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↗
PubMed2006

The CAP cancer protocols--a case study of caCORE based data standards implementation to integrate with the Cancer Biomedical Informatics Grid.

BACKGROUND: The Cancer Biomedical Informatics Grid (caBIG) is a network of individuals and institutions, creating a world wide web of cancer research. An important aspect of this informatics effort is the development of consistent practices for data standards development, using a multi-tier approach that facilitates semantic interoperability of systems. The semantic tiers include (1) information models, (2) common data elements, and (3) controlled terminologies and ontologies. The College of American Pathologists (CAP) cancer protocols and checklists are an important reporting standard in pathology, for which no complete electronic data standard is currently available. METHODS: In this manuscript, we provide a case study of Cancer Common Ontologic Representation Environment (caCORE) data standard implementation of the CAP cancer protocols and checklists model--an existing and complex paper based standard. We illustrate the basic principles, goals and methodology for developing caBIG models. RESULTS: Using this example, we describe the process required to develop the model, the technologies and data standards on which the process and models are based, and the results of the modeling effort. We address difficulties we encountered and modifications to caCORE that will address these problems. In addition, we describe four ongoing development projects that will use the emerging CAP data standards to achieve integration of tissue banking and laboratory information systems. CONCLUSION: The CAP cancer checklists can be used as the basis for an electronic data standard in pathology using the caBIG semantic modeling methodology.

Clinical Protocols↗
PubMed2002

Inter-rater agreement in the scoring of abstracts submitted to a primary care research conference.

BACKGROUND: Checklists for peer review aim to guide referees when assessing the quality of papers, but little evidence exists on the extent to which referees agree when evaluating the same paper. The aim of this study was to investigate agreement on dimensions of a checklist between two referees when evaluating abstracts submitted for a primary care conference. METHODS: Anonymised abstracts were scored using a structured assessment comprising seven categories. Between one (poor) and four (excellent) marks were awarded for each category, giving a maximum possible score of 28 marks. Every abstract was assessed independently by two referees and agreement measured using intraclass correlation coefficients. Mean total scores of abstracts accepted and rejected for the meeting were compared using an unpaired t test. RESULTS: Of 52 abstracts, agreement between reviewers was greater for three components relating to study design (adjusted intraclass correlation coefficients 0.40 to 0.45) compared to four components relating to more subjective elements such as the importance of the study and likelihood of provoking discussion (0.01 to 0.25). Mean score for accepted abstracts was significantly greater than those that were rejected (17.4 versus 14.6, 95% CI for difference 1.3 to 4.1, p = 0.0003). CONCLUSIONS: The findings suggest that inclusion of subjective components in a review checklist may result in greater disagreement between reviewers. However in terms of overall quality scores, abstracts accepted for the meeting were rated significantly higher than those that were rejected.

Abstracting and Indexing↗
PubMed2005

Standards update on perfusion equipment and practice.

Standards applying to the manufacture, testing and labeling of perfusion components and equipment, as well as those dealing with clinical use of extracorporeal circulation, have been promulgated by both standards-setting organizations and professional organizations. The rationale and purpose for device standards are discussed, and many organizations and the processes involved in developing standards are described. Perfusion checklists used during equipment set-up, use and at termination have a long track record of acceptance by clinicians. Evolving techniques have prompted revisions to the basic perfusion checklist, which should be considered a guide for development of institution-specific checklists. Current and future work by international standards-setting organizations is described.

Cardiopulmonary Bypass↗
PubMed2003

Symptoms and concerns amongst cancer outpatients: identifying the need for specialist palliative care.

This study aimed to define and prioritize the need for specialist palliative care (SPC) in cancer outpatient clinics. A validated assessment tool, the Symptoms and Concerns Checklist, was used to determine the prevalence and severity of symptoms and concerns. The checklist was completed by 480 outpatients with a cancer diagnosis. Sixty patients from each of eight primary tumour groups (lung, breast, gastrointestinal, gynaecological, urological, head and neck, brain and lymphoma) were recruited. The majority of patients (over 90%) rated 27 of the 29 checklist items, reporting a mean of 10 items as current problems. The influences of disease site and status, demographic factors and treatment on the number and type of symptoms and concerns reported were investigated. The highest number of symptoms and concerns and most severe problems were reported by patients with lung cancer, followed by those with brain tumours; the lowest by those with lymphoma and urological tumours. A high proportion of patients (83%) reported one or more items likely to benefit from SPC intervention. The results of this study suggest an extensive need for better symptom control in all cancer outpatients and in centres where SPC resources are limited, priority could be given to patients attending lung and brain tumour clinics.

Adult↗
PubMed2026

Persistent trauma three decades after the Halabja massacre: psychological symptom profiles and hair cortisol levels in gas attack survivors.

BACKGROUND: Survivors of the 1988 Halabja chemical attack have experienced severe, chronic trauma, yet limited research has examined the long-term psychological and biological consequences of chemical warfare exposure more than three decades later. AIMS: To examine long-term post-traumatic stress disorder (PTSD) symptoms, depression/anxiety symptoms, somatic symptoms and perceived stress among survivors of the Halabja chemical attack, and to investigate the associations of trauma exposure, sociodemographic factors and hair cortisol concentrations (HCCs) with psychological symptom severity and symptom profiles. METHOD: A total of 209 survivors of the Halabja chemical attack participated in structured interviews using culturally adapted and field-tested instruments, including the Post-Traumatic Stress Disorder Checklist for DSM-5, Hopkins Symptom Checklist-25, the Patient Health Questionnaire-13, the Perceived Stress Scale-14 and an adapted War and Adversity Exposure Checklist-26. Hair cortisol and cortisone concentrations were assessed as biomarkers of chronic stress. Data were analysed using correlations, independent-samples t-tests, multiple linear regression analyses, multinomial logistic regression and latent profile analysis (LPA). RESULTS: Survivors demonstrated a substantial long-term psychological symptom burden. Overall, 87.6% of participants exceeded the cut-off for probable PTSD symptoms, and 75.1% exceeded the cut-off for elevated depression/anxiety symptoms. Most participants (81.8%) reported exposure to 11 or more lifetime traumatic events. Men reported significantly greater cumulative trauma exposure, whereas women reported significantly greater somatic symptom severity. Higher educational attainment and employment were consistently associated with lower psychological symptom severity across multiple outcomes. HCCs were not significantly associated with PTSD symptoms or latent symptom-profile membership after adjustment for trauma exposure and psychosocial variables. The LPA identified four symptom-severity classes characterised by differing levels of PTSD and depression/anxiety symptoms. Greater cumulative trauma exposure and lower social support were associated with membership in more severe symptom classes. CONCLUSIONS: Survivors of the Halabja chemical attack continue to experience substantial psychological distress more than three decades after exposure. Long-term symptom severity appears to be more strongly associated with cumulative trauma exposure and psychosocial adversity than with HCCs. The findings highlight substantial heterogeneity in symptom presentation and support the need for long-term, culturally sensitive and trauma-informed mental health interventions for survivors of chemical warfare and mass violence.

Halabja chemical attack↗
PubMed2004

Assessment of resident professionalism using high-fidelity simulation of ethical dilemmas.

OBJECTIVES: To examine the responses of emergency medicine residents (EMRs) to ethical dilemmas in high-fidelity patient simulations as a means of assessing resident professionalism. METHODS: This cross-sectional observational study included all EMRs at a three-year training program. Subjects were excluded if they were unable or unwilling to participate. Each resident subject participated in a simulated critical patient encounter during an Emergency Medicine Crisis Resource Management course. An ethical dilemma was introduced before the end of each simulated encounter. Resident responses to that dilemma were compared with a professional performance checklist evaluation. Multi-response permutation procedure analysis was used to compare performance measures between resident classes, with the a priori hypothesis that mean performance should increase as experience increases. RESULTS: Of the 30 potential subjects, 90% (27) participated. The remaining three residents were unavailable due to scheduling conflicts. It was observed that senior residents (second and third year) performed more checklist items than did first-year residents (p < 0.028 for each senior class). Omnibus comparison of mean critical actions completed across all three years was not statistically significant (p < 0.13). Residents performed a critical action with 100% uniformity across training years in only one ethical scenario ("Practicing Procedures on the Recently Dead"). Residents performed the fewest critical actions and overall checklist items for the "Patient Confidentiality" case. CONCLUSIONS: Senior residents had better overall performance than incoming interns, suggesting that professional behaviors are learned through some facet of residency training. Although limited by small sample size, the application of this performance-assessment tool showed the ability to discriminate between experienced and inexperienced EMRs with respect to a variety of aspects of professional competency. These findings suggest a need for improved resident education in areas of professionalism and ethics.

Accreditation↗
PubMed2006

Web-based learning versus standardized patients for teaching clinical diagnosis: a randomized, controlled, crossover trial.

BACKGROUND: Little evidence exists to guide the selection of methods for teaching clinical diagnosis. PURPOSE: To compare the efficacy, student preference, and cost of a Web-based (WB) program versus a standardized patient (SP) encounter for teaching clinical diagnosis skills to 2nd-year medical students. METHODS: Randomized, controlled, crossover study comparing WB versus SP-based teaching for the clinical diagnosis of abdominal pain and headache. Outcome measures were performance on a 2-case SP examination (scored on the basis of a checklist completed by a faculty observer and an objective score on a postencounter subjective-objective assessment plan [SOAP] note), format preferences as assessed by end-of-course evaluations, and cost. RESULTS: Thirty students consented to participate. WB and SP training produced similar scores on both the Abdominal Pain checklist (66% vs. 62%; p = .17) and Headache checklist (56% vs. 63%; p = .07). WB training produced a higher score on the Abdominal Pain SOAP note (69% vs. 47%; p = .006), but not the Headache SOAP note (69% vs. 67%; p = .85). Students rated the SP format higher than the WB format on all 7 preference measures. Start-up costs were estimated at 2,190 dollars for the SP format and 2,250 dollars for the WB format. Ongoing costs per case per student were estimated to be 45 dollars for the SP format and 30 dollars for the WB format. CONCLUSIONS: WB and SP learning outcomes were comparable, but students preferred the SP format. Start-up costs were comparable, but the ongoing costs of the WB format were less expensive, suggesting that WB teaching may be a viable strategy.

Algorithms↗
PubMed2003

Identification of gaps in the achievement of undergraduate anesthesia educational objectives using high-fidelity patient simulation.

UNLABELLED: In this study we sought to identify educational gaps in medical students' knowledge using human patient simulation. The Undergraduate Committee developed 10 scenarios based on anesthesia curriculum objectives. Checklists were designed by asking 15 faculty members involved in undergraduate education to propose expected performance items at a level appropriate for medical students. These items consisted of essential performance items as well as critical management omissions. Checklists were used to score students' videotaped performances. Checklist items common to more than one scenario were grouped for data analysis and identification of gaps in achievement of educational objectives. Eighteen groupings of expected performance criteria and 8 groupings of critical management omissions were established. Performance data of 165 students were analyzed. Common management omissions were lack of adequate airway management, failure to check blood pressure, and failure to stop the anesthetic. Students reliably performed defibrillation, notation of vital signs, auscultation of lung fields, and administration of IV fluids. The most common critical omissions were failing to a). call for help, b). take a history/do physical examination, and c). prepare airway equipment. Management and critical omissions noted during performance assessments provide information regarding students' educational needs, enabling faculty to focus attention on demonstrated areas of weakness. IMPLICATIONS: This study involved the use of high-fidelity patient simulation that offers standardized clinical experiences that can detect gaps in medical students' knowledge base and clinical performance. This information can be used by faculty to focus their teaching efforts to ensure competency in important educational areas.

Anesthesiology↗
PubMed2004

The development and application of an instrument for assessing resident competence during preanesthesia consultation.

In this study, we aimed to construct, validate, and apply an instrument for assessing resident performance at outpatient preanesthesia consultation (PAC). A focus group and a Delphi panel of experts defined component items of a typical outpatient PAC, which could be used as indicators of competence. Items were incorporated in a checklist, which was further validated in a sample of consultations performed by board-certified anesthesiologists. The resulting instrument contained 37 items, grouped into five domains (physician-patient relationship, medical history, physical examination, patient education, and preanesthesia records), with high construct validity, high discriminant validity, moderate internal consistency, and high probability of inter-raters agreement. The instrument was applied to evaluate the performance of seven first-year residents at 317 consecutive PAC. Data were analyzed by constructing exponentially weighted moving average charts for domain and total scores. Statistically significant differing levels of performance could be consistently detected. Applying exponentially weighted moving average charts to the sequential analysis of the developed checklist scores can reliably assess resident performance at the devised criteria. The Preanesthesia Consultation Scoring Checklist is a potentially useful instrument for both formative and summative assessment of residents during their training in processes involved in outpatient preanesthesia evaluation.

Anesthesia↗
PubMed2006

Incorporating simulation-based objective structured clinical examination into the Israeli National Board Examination in Anesthesiology.

We describe the unique process whereby simulation-based, objective structured clinical evaluation (OSCE) has been incorporated into the Israeli board examination in anesthesiology. Development of the examination included three steps: a) definition of clinical conditions that residents are required to handle competently, b) definition of tasks pertaining to each of the conditions, and c) incorporation of the tasks into hands-on simulation-based examination stations in the OSCE format, including 1) trauma management, 2) resuscitation, 3) crisis management in the operating room, 4) regional anesthesia, and 5) mechanical ventilation. Members of the Israeli Board of Anesthesiology Examination Committee assisted by experts from the Israel Center for Medical Simulation and from Israel's National Institute for Testing and Evaluation were involved in this process and in the development of the assessment tools, orientation of examinees, and preparation of examiners. The examination has been administered 4 times in the past 2 yr to 104 examinees and has gradually progressed from being a minor part of the oral board examination to a prerequisite component of this test. The pass rate ranged from 70% in resuscitation to 91% in regional anesthesia. The mean inter-rater correlations for all the checklist items, for the score based on the critical checklist items only, and for the general rating were 0.89, 0.86, and 0.76, respectively. The overall Kappa coefficients (the inter-rater agreement coefficient) for the total score and the critical checklist items were 0.71 and 0.76, respectively. The correlation between the total score and the general score was 0.76. According to a subjective feedback questionnaire, most (70%-90%) participants found the difficulty level of the examination stations reasonable to very easy and prefer this method of examination to a conventional oral examination. The incorporation of OSCE-driven modalities in the certification of anesthesiologists in Israel is a continuing process of evaluation and assessment.

Anesthesiology↗
PubMed2003

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

BACKGROUND: 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 generalizability 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 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 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 the clinicians, researchers, reviewers, journals and the public.

Diagnostic Errors↗
PubMed2001

Improving referrals for glue ear from primary care: are multiple interventions better than one alone?

OBJECTIVES: To evaluate the effect of a risk factor checklist and training video for general practitioners in reducing inter-practice variation and improving the appropriateness of referrals (assessed by their positive predictive value or PPV) of patients with suspected otitis media with effusion (OME or 'glue ear') to secondary care. METHODS: Fifty general practices (177 practitioners) from the NHS Trent region and the West of Scotland were cluster-randomised either to a control group (n = 12) or to one of three intervention groups (training video (n = 16), checklist (n = 11), or both (n = 11)). Data on all paediatric ear, nose and throat (ENT) referrals and diagnostic results at ENT clinics were collected for a one-year period pre- and post-intervention. Referral rates for OME and for closely related conditions were calculated for children aged 0-15 years, based on each practice's list size. PPV was defined as the proportion of referrals resulting in bilateral hearing loss > or = 20 dB at the ENT outpatient department. RESULTS: There was a significant improvement in the PPV, adjusted for patients' waiting time between general practitioner (GP) referral and being seen at the ENT department. The improvement in PPV pre- and post-intervention was 15% (95% confidence interval, CI: -12.1% to 41.7%) for the practices receiving both interventions, compared with a degradation of 20% pre- and post-intervention (95% CI: -32.9% to -6.4%) for practices receiving only one intervention and a degradation of 34% for those receiving no intervention. CONCLUSIONS: Disseminating a risk factor checklist and training video on glue ear to GPs using a multi-channel approach can improve the quality of referrals to ENT.

Adolescent↗
PubMed2006

Human factors in action: getting "pumped" at a nursing usability laboratory.

We describe our experience with a Nursing Usability Laboratory, where human factors design principles were applied to common nursing procedures. Our first step was to develop a human factors usability checklist. We then used this checklist while observing 11 nurses completing two standardized tasks on a simulated patient: (1) programming an insulin infusion and (2) programming a heparin infusion. We found that a usability checklist can help to uncover systematic error-provoking conditions in nursing tasks, that immediate improvements can be made in nursing training and practice and that participant nurses found the process useful. This paper will be of interest to any hospital seeking to enhance safety by applying human factors design principles.

Ergonomics↗
PubMed1997

Development of the menopause symptom list: a factor analytic study of menopause associated symptoms.

This paper outlines the development of a menopausal symptom checklist amongst a community sample of 40 women aged between 45-55 years. Participants completed an atheoretical symptom checklist of 56 symptoms that have previously been associated with menopause. Following two principal components factor solutions, three factors containing 25 symptoms emerged as significant. Interpretation of the three factor solution was straightforward with the factors labelled psychological, vaso-somatic, and general somatic. These symptoms formed the item pool for the Menopause Symptom List (MSL). Unique psychometric properties of the MSL make this instrument a useful clinical and research tool. Symptoms are operationally defined, scored separately for both frequency of occurrence and severity upon 6-point rating scales which provide sensitivity in detecting changes in symptomatology. Advantages of the MSL over existing climacteric symptom checklists is discussed.

Factor Analysis, Statistical↗
PubMed2006

Measurement of food availability in the home.

The importance of environment on food choices has recently received increased attention. One environment likely to be influential is the home food environment. This review examines 23 studies that used either researcher-conducted open inventories or self-report checklists to assess food availability in the home. Only three were open inventories (this technique is rarely used, most likely because of low feasibility). Self-report checklists varied in length and the items included. Two checklists, validated using observation, showed high sensitivity and specificity (87% or above). We provide recommendations to develop and validate population-specific tools that measure home food availability.

Food Supply↗
PubMed1998

Problem behaviors associated with deletion Prader-Willi, Smith-Magenis, and cri du chat syndromes.

Problem behaviors of individuals who had one of three chromosome deletion disorders (5p- cri-du-chat, 15q- Prader-Willi, or 17p- Smith-Magenis) were investigated. The Aberrant Behavior Checklist was used. Results were contrasted with those of two groups of people with mental retardation who were described in other studies. The checklist rates many, but not all, potentially relevant behaviors. Eating abnormalities, known to be problematic in Prader-Willi syndrome, and sleep abnormalities, believed to be problematic in Smith-Magenis syndrome, were not included in the survey. All three disorders were associated with greater ratings of problem behaviors than the comparison groups on at least one subscale of the checklist. The results lend support to the partial specificity model of behaviors associated with genetically determined syndromes.

Adolescent↗
PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy.

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 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 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 clinicians, researchers, reviewers, journals, and the public.

Algorithms↗