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Optimising the reproducibility of a performance-based assessment test in midwifery education.

Despite problems concerning generalisability of test results - largely due to limited sampling of the task domain - and questions about test efficiency, the popularity of OSCEs in medical education has motivated the use of similar assessment methods in other health care domains. Purpose of this study was to investigate reproducibility of scores on an OSCE-based test in the relatively narrow domain of midwifery, as compared to the broad medical domain. The influence of global rating scales and adoption of a mastery-oriented test perspective on reproducibility of test scores was investigated in order to explore possibilities to increase test efficiency.A 3-hr, 6-station performance based test was administered to third and fourth year students at Kerkrade Midwifery School (the Netherlands). Students' performance was recorded using a station specific checklist and a global rating scale. For the 3-hr OSCE the generalisability coefficient based on checklist scores is 0.48. Based on global ratings alone, the generalisability coefficient is 0.61. Adjusted dependability indices are 0.85 based on checklist scores and 0.95 for global ratings respectively. Results suggest that even for small domains the problem of case-specificity remains a major impediment to high stakes performance testing. Findings furthermore suggest that use of global rating scales and professional expert judgements in professional competence evaluation is to be preferred to task specific checklists for reasons of reproducibility and efficiency in test development and administration. Adoption of a mastery oriented test perspective may reduce testing time requirements even further.

Certification↗

Clinical correlates of Breslow thickness of malignant melanoma.

BACKGROUND: Breslow thickness is a major predictor of prognosis in cutaneous malignant melanoma (MM) and patients continue to present with thick lesions, which have a poorer prognosis. OBJECTIVES: To investigate correlations of Breslow thickness with demographic variables, tumour site, clinical features, false negative diagnostic rate and clinic of primary referral. METHODS: Data were obtained from the records of 738 patients with histologically diagnosed cutaneous MM. Tumours included were in situ and invasive MM and lentigo maligna melanoma. In view of the skewed distribution of MM thickness, categories of MM thickness were used for analysis, using the commonly applied cut-offs of 0.75, 1.5 and 3.5 mm. The variables investigated were particularly associated with changes in the proportion of the thickest group, 'thick' MMs. The proportion of this thickness category is proposed as an appropriate and sensitive variable for the investigation of correlations with MM thickness. Thickness >/= 1.5 mm has also been considered in view of its prognostic significance. RESULTS: Results were similar for the two thickness groups, but more significant for the thick group. The previously described correlations of tumour thickness and increasing age (P < 0.00001) and location on head and neck (P = 0.0002), together with the independence of these variables, have been confirmed. The correlation with male gender was also confirmed but this was weak (P = 0.05). Novel findings were correlations of Breslow thickness with all features of the seven-point checklist (P varying from P = 0.01 to P < 0.00001) and tumour elevation (P < 0.00001). In general in the seven-point checklist, the absence of the major features (except variation in size) (P < 0.00001) and presence of minor features (except altered sensation) (P varying from P = 0.004 to P < 0.00001) were strongly associated with thick MMs. These results for tumour thickness are a further argument for retention of the minor features of the seven-point checklist. False negative diagnosis was found to be correlated with tumour thickness (P < 0.02) but this relationship was lost on multivariate analysis with inclusion of the clinical features. MM thickness was highly correlated with primary referral clinic (P < 0.00001). Only approximately 8% of MMs presenting to the Pigmented Lesion Clinic (PLC) were thick, while the proportion presenting to general dermatology was about three times greater and to plastic surgery about five times greater. This was maintained on multivariate analysis, including all other variables and, therefore, there must be other determining factors of referral not examined in the study. Conclusion MM thickness is associated with increasing age, male gender, location on the head and neck, all features of the seven-point checklist, tumour elevation and referral to the PLC. It is important to investigate further the reasons for general practitioner referral of different thickness MM to different types of clinic, as referral to clinics other than the PLC results in delay in the first hospital appointment, and it is now apparent that thicker lesions are disproportionately affected.

Age Factors↗

Objective structured assessment of technical skill (OSATS) for surgical residents.

BACKGROUND: The technical skill of surgical trainees is not well assessed. This study aimed (1) to compare the reliability of three scoring systems, (2) to compare live and bench formats and (3) to assess construct validity of a test of operative skill. METHODS: Parallel examinations of operative skill, one using live animals and one using simulations, were developed. Performance was graded using operation-specific checklists, detailed global rating forms and pass/fail judgements. Twenty surgical residents each took both formats. RESULTS: Disattenuated correlations between live and bench scores were high (0.69-0.72). Mean interrater reliability across stations ranged from 0.64 to 0.72. Internal consistency was moderate to high (alpha: 0.61-0.74) for the live format using the checklist and for live and bench formats using global ratings. Global ratings discriminated between resident levels for both formats (bench: F(2,17) = 4.45, P < 0.05; live: F(2,17) = 3.55, P < 0.05), checklists did not. CONCLUSION: This preliminary study suggests that the Objective Structured Assessment of Technical Skill can reliably and validly assess surgical skills. Global ratings are a better method of assessment than task-specific checklists. Bench model simulation gives equivalent results to use of live animals for this test format.

Clinical Competence↗

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. QUOROM Group.

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

Data Collection↗

Improvement of patient education and information: development of a patient's information dossier.

The demand for patient information in modern medical care is increasing and sound information for patients is becoming a necessity. For haemophilia patients, information about their disease and its complications is already widely available. In order to increase the organization of this information, a 'Patient Information Dossier' (PID) and communication check lists were developed at the Dutch National Hemophilia Center, the Van Creveldkliniek, in cooperation with the Department of Patient Education of the University Medical Center Utrecht. The PID has an unique double function: (1) it contains patient tailored information about the practical facts of hospital care; and (2) it provides a communication checklist used by various members of the comprehensive care team, in order to supply patients with more uniform information. In order to gain a better insight of the gaps in information supply, according to patients and healthcare workers, the Department of Patient Education formulated a questionnaire. The PID itself was written by a study group consisting of members of the comprehensive care team. The entire process was developed, edited and coordinated by an advisor of the Department of Patient Education. The above-mentioned study group developed a specific PID on haemophilia care. Its 10 chapters provide information and guidelines, and advise patients where to find more information about this subject. Each chapter includes a checklist for patients, enabling them to prepare subjects for discussion during clinical visits. The team also developed a communication checklist to be used by various team members during a patient's visit to the clinic, as well as specific checklists covering the possible problem subjects of the PID. The PID is the lifelong property of the patient, and can be used during each visit to the clinic. The PID was implemented in February 2000, and within 4 months, was distributed among 200 patients visiting the Van Creveldkliniek. Evaluation by use of a questionnaire showed that most patients found the information in the PID sufficient and in accordance with that which they had received previously.

Hemophilia A↗

Measuring compliance with preventive care guidelines: standardized patients, clinical vignettes, and the medical record.

OBJECTIVE: To determine how accurately preventive care reported in the medical record reflects actual physician practice or competence. DESIGN: Scoring criteria based on national guidelines were developed for 7 separate items of preventive care. The preventive care provided by randomly selected physicians was measured prospectively for each of the 7 items. Three measurement methods were used for comparison: (1) the abstracted medical record from a standardized patient (SP) visit; (2) explicit reports of physician practice during those visits from the SPs, who were actors trained to present undetected as patients; and (3) physician responses to written case scenarios (vignettes) identical to the SP presentations. SETTING: The general medicine primary care clinics of two university-afflliated VA medical centers. PARTICIPANTS: Twenty randomly selected physicians (10 at each site) from among eligible second- and third-year general internal medicine residents and attending physicians. MEASUREMENTS AND MAIN RESULTS: Physicians saw 160 SPs (8 cases x 20 physicians). We calculated the percentage of visits in which each prevention item was recorded in the chart, determined the marginal percentage improvement of SP checklists and vignettes over chart abstraction alone, and compared the three methods using an analysis-of-variance model. We found that chart abstraction underestimated overall prevention compliance by 16% (P < .01) compared with SP checklists. Chart abstraction scores were lower than SP checklists for all seven items and lower than vignettes for four items. The marginal percentage improvement of SP checklists and vignettes to performance as measured by chart abstraction was significant for all seven prevention items and raised the overall prevention scores from 46% to 72% (P < .0001). CONCLUSIONS: These data indicate that physicians perform more preventive care than they report in the medical record. Thus, benchmarks of preventive care by individual physicians and institutions that rely solely on the medical record may be misleading, at best.

Adult↗

Posttraumatic headache: biopsychosocial comparisons with multiple control groups.

OBJECTIVE: This study examined somatic, psychological, and cognitive functioning of subjects with posttraumatic headache in comparison with multiple control groups. BACKGROUND: Posttraumatic headache is not as widely studied as other forms of headache (eg, tension-type, migraine). Previous research has suggested poor psychological functioning in patients with posttraumatic headache in comparison with other groups of patients with pain; however, this group has yet to be compared with a group of persons who have experienced trauma but are headache-free. DESIGN AND METHODS: Nineteen subjects with posttraumatic headache were studied, with full assessments available for 14 participants. Comparison groups, containing 16 participants each, included another headache group, a nonheadache group, and a trauma (motor vehicle accident) survivor nonheadache group. Participants completed several measures assessing somatic, psychological, and cognitive functioning. RESULTS: Findings revealed that the posttraumatic headache group exhibited significantly poorer functioning than the comparison groups on several measures including the Psychosomatic Symptom Checklist, Postconcussion Syndrome Checklist, axis II psychiatric diagnoses, Minnesota Multiphasic Personality Inventory, and the Daily Hassles Scale (frequency and total). Additionally, they scored higher on the following: number of axis I psychiatric diagnoses, the Daily Hassles Scale (intensity), Beck Depression Inventory, State-Trait Anxiety Inventory, and State-Trait Anger Expression Inventory. The posttraumatic headache group was similar to the other trauma group on the Posttraumatic Stress Disorder Symptom Checklist and the Life-Trauma Checklist. CONCLUSIONS: This study confirmed the distress seen in this understudied population of persons with headache and highlights areas of focus for proper assessment and treatment of those with headache and who have had an accident.

Accidents, Traffic↗

Identifying hazards in complex ecological systems. Part 3: Hierarchical Holographic Model for herbicide tolerant oilseed rape.

This paper is the third in a series designed to demonstrate the application of rigorous, systematic hazard identification techniques to ecological systems. Here we use Hierarchical Holographic Modelling to identify the potential ecological hazards associated with the commercial release of herbicide tolerant oilseed rape. Hierarchical Holographic Models decompose complex systems into a series of sub-systems and consider interactions between the components and processes of these sub-systems in order to identify hazards. In this example we considered 1356 potential interactions between the biological, chemical and physical components and processes of the herbicide tolerant oilseed rape environment, and identified 152 potential hazards, grouped into 14 categories. The hazards were subsequently scored for degree of concern and plausibility, and then compared with an equivalent list of hazards generated independently by a checklist approach. The incidence of herbicide tolerant volunteers (and weeds) both on and off the farm had the highest average score of all the ecological hazard categories. The checklist based approach identified or implied 44% of the hazards identified in the Hierarchical Holographic Model, including nine of the ten hazards ranked most important. The checklist approach focussed almost exclusively on the phenotypic and genotypic hazards associated with herbicide tolerant oilseed rape and largely ignored the hazards associated with the circumstances surrounding its use. As a result the checklist identified only 6 out of the 79 potential hazards associated with changes to farming practice. The commercial release of herbicide tolerant oilseed rape will be associated with changes in tillage and the application of post-emergent herbicides. It may also lead to changes in spray schedules of insecticide and fungicide. Many of the environmental hazards identified with these changes are plausible and may warrant further investigation or targeted monitoring.

Brassica napus↗

Surgical skills assessment: a blinded examination of obstetrics and gynecology residents.

OBJECTIVE: We have previously shown that objective structured assessment of technical skills (OSATS) is an innovative, reliable, and valid method of assessing surgical skills. Our goal was to establish the feasibility, reliability, and validity of our surgical skills assessment instrument when administered in a blinded fashion. STUDY DESIGN: A 7-station OSATS was administered to 16 obstetric and gynecology residents from Madigan Army Medical Center. The test included laparoscopic (salpingostomy, intracorporeal knot, and ligation of vessels with clips) and open abdominal procedures (subcuticular closure, bladder neck suspension, enterotomy repair, and abdominal wall closure). All tasks were performed with lifelike surgical models. Residents were timed and assessed at each station with 3 methods of scoring: task-specific checklist, global rating scale, and pass/fail grade. Each resident was evaluated by one examiner blinded as to the postgraduate year level and one examiner who had previously worked with the resident. RESULTS: Assessment of construct validity (the ability to distinguish between resident levels) found significant differences on the checklist, global rating scale, and pass/fail grade by residency level for both blinded and unblinded examiners. Reliability indices calculated with Cronbach's alpha were.82 for the checklists and.93 for the global rating scale. Overall interrater reliability between blinded and unblinded examiners was 0.95 for global rating scale and ranged from 0.74 to 0.97 for the checklists. The cost to administer the exam for the 16 residents was approximately $1000. CONCLUSIONS: OSATS administered in either a blinded or unblinded fashion can assess residents' surgical skills with a high degree of reliability and validity. This study provides further evidence that OSATS can be used to establish surgical competence.

Clinical Competence↗

Assessing the head-to-toe physical examination skills of medical students.

Second-year medical students performed a head-to-toe screening physical examination on trained patient instructors (PIs) as a high-stakes examination before beginning clinical clerkships. PIs completed a 138-item checklist and instructed the students in the proper performance of any incorrectly executed or omitted items. To assess the accuracy of the PI ratings, 'monitor' PIs watching the encounter by video completed checklists for 11 retests of failed students in 2001 and for 28 randomly selected encounters in 2002. Checklist-level discrepancies measured by mean absolute checklist difference were 8% in 2001 and 9% in 2002. Case-level mean difference between raters in 2002 was -2.9%. The inter-rater reliability for a single rater, estimated by the intra-class correlation coefficient for total encounter scores, was 0.95. The assessment and feedback were well received by the students. The Head-to-Toe examination provides a reliable assessment of a student's ability to carry out a complete screening physical examination. Patient instructors can be trained to acceptable accuracy and reliability despite the length and complexity of the exercise, and can provide effective feedback and teaching targeted to individual student deficiencies.

Clinical Competence↗

Quality of reporting of observational longitudinal research.

Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making. However, there are no structured reporting requirements for studies of this design to assist authors, editors, and readers. The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies. The checklist criteria concerned recruitment, data collection, biases, and data analysis and descriptive issues relevant to study rationale, study population, and generalizability. Two raters independently assessed 49 randomly selected articles describing stroke research published from 1999 to 2003 in six journals: American Journal of Epidemiology, Journal of Epidemiology and Community Health, Stroke, Annals of Neurology, Archives of Physical Medicine and Rehabilitation, and American Journal of Physical Medicine and Rehabilitation. On average, 17 of the 33 checklist criteria were reported. Criteria describing the study design were better reported than those related to internal validity. No relation was found between study type (etiologic or prognostic) or word count and quality of reporting. A flow diagram for summarizing participant flow through a study was developed. Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research.

Epidemiology↗

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

OBJECTIVE: Our aim was 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 about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation and/or the reference standard. 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.

Bias↗

Improving primary health care through systematic supervision: a controlled field trial.

Most primary health care services in developing countries are delivered by staff working in peripheral facilities where supervision is problematic. This study examined whether systematic supervision using an objective set of indicators could improve health worker performance. A checklist was developed by the Philippine Department of Health which assigned a score from 0 to 3 on each of 20 indicators which were clearly defined. The checklist was implemented in 4 remote provinces with 6 provinces from the same regions serving as a control area. In all 10 provinces, health facilities were randomly selected and surveyed before implementation of the checklist and again 6 months later. Performance, as measured by the combined scores on the 20 indicators, improved 42% (95% Cl = 29% to 55%) in the experimental group compared to 18% (95% Cl = 9% to 27%) in the control group. In the experimental, but not in the control facilities, there was a correlation between frequency of supervision and improvements in scores. The initial cost of implementing the checklist was US $ 19.92 per health facility and the annual recurrent costs were estimated at $ 1.85. Systematic supervision using clearly defined and quantifiable indicators can improve service delivery considerably, at modest cost.

Developing Countries↗

Validation of an objective structured clinical examination in psychiatry.

PURPOSE: To examine the validity of a psychiatry clerkship's objective structured clinical examination (OSCE). METHOD: In 1996, 33 clinical clerks and 17 psychiatry residents at the University of Toronto participated in an eight-station OSCE evaluated by psychiatrist-examiners using binary checklists and global ratings. Prior to the OSCE, communication course instructors were asked to rank the clerks on interviewing ability, and faculty supervisors were asked to identify the OSCE stations on which the clerks were likely to do well or poorly. RESULTS: Mean OSCE scores were significantly higher for the residents than for the clerks on global ratings but not on checklists. The communication instructors accurately predicted the clerks' rankings on the global scores but not their scores on the checklists. The faculty supervisors predicted with moderate accuracy the clerks' success on the OSCE stations as measured by the checklists but not by the global ratings. The residents rated the OSCE scenarios as highly realistic. CONCLUSIONS: The evidence of construct and concurrent validity together with high ratings of realism suggest that a psychiatry OSCE can be a valid assessment of clerks' clinical competence.

Clinical Clerkship↗

The Patient Findings Questionnaire: one solution to an important standardized patient examination problem.

PURPOSE: To describe the Patient Findings Questionnaire (PFQ) and compare its scores and pass/fail decisions with those obtained from standardized patient (SP) examination checklists. METHOD: Checklists and PFQs were used to assess data acquisition by 790 second-year medical students. PFQs were composed of multiple-choice items designed to determine whether examines had acquired key historical patient information. RESULTS: At the item level, the two measurement methods yielded the same decisions about data acquisition on 88% of observed occasions. Most discrepancies (74%) involved SPs rating examinees as having elicited information when the examinee was unable to answer the associated PFQ item. At the test level, the two instruments yielded the same pass/fail decision on a large majority of occasions. CONCLUSIONS: The PFQ and checklist yielded similar data acquisition scores and decisions at the item and test levels. Replacement of the checklist with the PFQ should result in examinees' behaving in a way more consistent with recommended interviewing practices.

Chicago↗

Early assessment of medical students' clinical skills.

OBJECTIVE: To provide first-year medical students with a non-threatening, standardized, clinical-skills assessment at the end of the first year (M1CSA), and provide resources to help them build on their strengths and address any weaknesses before starting the second year. DESCRIPTION: Implemented for the first time in April 2001, the M1CSA was designed to help first-year students identify strengths and weaknesses in their developing repertoire of clinical skills. It was composed of five stations (abdominal exam, cardiovascular exam, lung exam, informed consent, social history) and a self-assessment. Each station involved working with a standardized patient (SP), and all SP encounters were videotaped so students could review their work during the self-assessment. The M1CSA was truly formative in nature; there was no passing or failing mark. To help students prepare for the abdominal, cardiovascular, and lung examinations, we distributed via Blackboard(R) an electronic copy of the same exam-skills checklists that the SPs would be using in the exam stations. To facilitate preparation for the social history and informed consent stations, we used Blackboard to provide the scenarios in advance. While students were not allowed to bring these checklists or scenario descriptions into the stations, they did know exactly what was expected. Immediately after each student encounter, SPs completed skills checklists and entered evaluative comments via computer workstations. Upon completing all five stations, students were provided with printouts of the checklists and comments, and proceeded to review their videotapes and write self-assessments indicating specific areas for improvement. Faculty members were available on-site to review portions of the videotapes, answer questions, and offer suggestions. Students also received a resource sheet, which listed faculty members and clinics where they could obtain help developing their clinical skills over the summer months. The M1CSA was designed by a clinical-skills assessment committee and refined through discussion with students. The committee was composed of all four of the first-and second-year clinical skills unit directors, as well as the Patient, Physician & Society course coordinator, the associate dean for medical informatics and computer-assisted learning, the two staff members of Northwestern's Clinical Education and Evaluation Center, the office of medical education's director of evaluation, and the associate dean for education (ex-officio). Students evaluated this first iteration of the M1CSA very positively, and provided useful feedback for making specific improvements. DISCUSSION: The primary motivation for implementing the M1CSA was the fact that, over the past several years, many students reported starting the second year with considerable uncertainty about their clinical skills. The M1CSA was designed to offer a standardized inventory of students' proficiencies, and to encourage continued development in anticipation of working with real patients in the second year. The content reflects a broad view of clinical skills, encompassing communication and ethics, as well as the physical examination. The formative nature of the M1CSA complements the long-standing M2CSA, which is summative (i.e., students must demonstrate proficiency before beginning clerkships).

Clinical Competence↗

Cancer treatment, symptom monitoring, and self-care in adults: pilot study.

A descriptive study was conducted on self-reported symptoms and self-care by 37 adults receiving chemotherapy primarily for leukemia, lymphomas, or breast cancer or radiation therapy for head and neck or lung cancers. The Therapy-Related Symptom Checklist and demographic and interview forms on self-care for identified symptoms were used. Severe symptoms on the Therapy-Related Symptom Checklist subscales fatigue, eating, nausea, pain, numbness in fingers/toes, hair loss, and constipation were reported by patients on chemotherapy. Those on radiation therapy reported severe symptoms on the eating, fatigue, skin changes, oropharynx, and constipation subscales.Self-care strategies were in the following categories, using complementary medicine as framework: diet/nutrition/lifestyle change (eg, use of nutritional supplements; modifications of food and of eating habits; naps, sleep, and rest); mind/body control (eg, relaxation methods, prayer, music, attending granddaughter's sports events); biologic treatments (vitamins); herbal treatments (green mint tea); and ethnomedicine (lime juice and garlic). The first category was predominantly used by patients in both treatment types. Medications were prescribed also to help control symptoms (eg, pain and nausea). Symptom monitoring and self-care for symptoms identified may be facilitated by the Therapy-Related Symptom Checklist; based on reported symptom severity, care providers may prioritize interventions. A larger study needs to be done on (a) the use of the Therapy-Related Symptom Checklist as a clinical tool to assess symptoms that oncology patients experience during therapy; (b) whether care providers, based on patient-reported symptom severity, can prioritize interventions--and how this influences the efficiency of care; (c) the self-care strategies used by patients on chemotherapy or radiation therapy or both; and (d) how useful these strategies are in alleviating symptoms.

Adult↗

Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial.

A single-item linear analogue self-assessment scale for mood was compared with a 28-item adjective checklist for emotional well-being. To confirm its concurrent validity and responsiveness to treatment and recurrence in patients with breast cancer, emotional well-being was assessed every 3 months for 2 years and at 1 and 6 months after recurrence in 1,169 patients who were premenopausal and 960 patients who were postmenopausal. These patients were enrolled in two International Breast Cancer Study Group randomized clinical trials in operable breast cancer conducted from 1986 to 1993. To assess concurrent validity, Pearson's correlation between the linear analogue self-assessment scale and the adjective checklist were calculated for each time-point within each treatment group and for the two assessments after recurrence. Responsiveness to treatment and recurrence were analyzed using paired t tests and the squared ratio of these t tests, an estimate of relative efficiency. Concurrent validity of the mood linear analogue self-assessment was consistently confirmed across four language groups. Both measures were responsive; out of 24 changes over time, 19 were in the expected direction for the linear analogue self-assessment scale (p < or = 0.05 for 9 of 19) and 17 for the adjective checklist (p < or = 0.05 for 10 of 17). The linear analogue self-assessment scale was less but significantly efficient for detection of treatment effects, with relative efficiency estimates ranging from 0.16 to 2.45 and a median of 0.66 among the comparisons with relatively stable estimates (/t/ > or = 1.0) and more efficient for recurrence than the adjective checklist. The mood linear analogue self-assessment scale is a valid indicator of emotional well-being in patients with breast cancer in large multicenter, multicultural trials in which comprehensive scales are less feasible. This investigation supports the clinical relevance of linear analogue self-assessment scales as indicators of components of quality of life in cancer clinical trials.

Adult↗