Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up

Postmenopausal women with hormone receptor-positive early breast cancer have persistent, long-term risk of breast-cancer recurrence and death. Therefore, trials assessing endocrine therapies for this patient population need extended follow-up. We present an update of efficacy outcomes in the Breast International Group (BIG) 1-98 study at 8·1 years median follow-up.

Sonographic Assessment of Fetal Cardiac Function: Indirect Measurements of Fetal Cardiac Function, Newer Techniques and Clinical Applications

Noninvasive blood flow measurements based on Doppler ultrasound studies are the main clinical tool for studying the cardiovascular status of fetuses at risk for circulatory compromise. Usually, qualitative analysis of peripheral arteries and in particular clinical situations such as severe growth restriction or volume overload also of venous vessels close to the heart or of flow patterns in the heart is being used to gauge the level of compensation in a fetus. However, quantitative assessment of the driving force of the fetal circulation, the cardiac output remains an elusive goal in fetal medicine. This article reviews the methods for direct and indirect assessment of cardiac function and explains new clinical applications. Part 1 of this review describes the concept of cardiac function and cardiac output and the techniques that have been used to quantify output. Part 2 summarizes the use of arterial and venous Doppler studies in the fetus and gives a detailed description of indirect measurements of cardiac function (like indices derived from the duration of segments of the cardiac cycle) with current examples of their application.

Assessment of three frequently used blood glucose monitoring devices in clinical routine

Self-monitoring of blood glucose plays an important role in the management of diabetes and has been shown to improve metabolic control. The use of blood glucose meters in clinical practice requires sufficient reliability to allow adequate treatment. Direct comparison of different blood glucose meters in clinical practice, independent of the manufactures is scarce. We, therefore, aimed to evaluate three frequently used blood glucose meters in daily clinical practice.

Relative bone width of the edentulous maxillary ridge. Clinical implications of digital assessment in presurgical implant planning

Healthy, well-structured mucosa may clinically disguise atrophic jawbone in preimplant diagnosis.

Comparative assessment of clinical performance of esthetic bracket materials

To compare the alterations in esthetic appearance and slot morphology/integrity of two main types of esthetic brackets caused after clinical use.

Clinical application and reliability of a post abdominal surgery pain assessment scale (PASPAS) in horses

The aim of this study was to refine a multi-dimensional scale based on physiological and behavioural parameters, known as the post abdominal surgery pain assessment scale (PASPAS), to quantify pain after laparotomy in horses. After a short introduction, eight observers used the scale to assess eight horses at multiple time points after laparotomy. In addition, a single observer was used to test the correlation of each parameter with the total pain index in 34 patients, and the effect of general anaesthesia on PASPAS was investigated in a control group of eight horses. Inter-observer variability was low (coefficient of variation 0.3), which indicated good reliability of PASPAS. The correlation of individual parameters with the total pain index differed between parameters. PASPAS, which was not influenced by general anaesthesia, was a useful tool to evaluate pain in horses after abdominal surgery and may also be useful to investigate analgesic protocols or for teaching purposes.

Laser Doppler flowmetry for assessment of anterior mandibular teeth in conjunction with bone harvesting in the symphysis: a clinical pilot study

PURPOSE: To evaluate the pulp sensitivity and vitality of mandibular incisors and canines before and after bone harvesting in the symphysis. MATERIALS AND METHODS: In 20 patients requiring bone grafts from the symphysis, pulp sensitivity (carbon dioxide [CO2]) and pulpal blood flow (laser Doppler flowmetry [LDF]) of mandibular incisors and canines were evaluated preoperatively, postoperatively, and 6 months after surgery. Teeth were allocated to 1 of 3 groups according to their initial and final reaction to CO2 (group A = teeth with a positive reaction throughout the study, group B = teeth that exhibited a sensitivity change from positive to negative, and group C = teeth with a negative reaction throughout the study). RESULTS: Preoperative flux measurements (LDF) did not differ between groups A, B, and C. Teeth with sensitivity changes (group B) showed the greatest decrease (a statistically significant decrease) of pulpal blood flow over time, whereas teeth in groups A and C demonstrated an insignificant reduction of flux over time. DISCUSSION AND CONCLUSIONS: LDF was purely used as an experimental tool in the present study. Pulpal blood flow measurements using LDF demonstrated a decrease of flux over time in anterior mandibular teeth following bone harvesting in the symphysis. A significant change of flux, however, was only observed for teeth that also demonstrated a loss of pulp sensitivity during the same study period. Loss of pulp sensitivity appeared to be correlated to a significant decrease of blood flow assessed by LDF.

Clinical and radiographic assessment of various predictors for healing outcome 1 year after periapical surgery

This clinical study prospectively evaluated the influence of various predictors on healing outcome 1 year after periapical surgery. The study cohort included 194 teeth in an equal number of patients. Three teeth were lost for the follow-up (1.5% drop-out rate). Clinical and radiographic measures were used to determine the healing outcome. For statistical analysis, results were dichotomized (healed versus nonhealed). The overall success rate was 83.8% (healed cases). The only individual predictors to prove significant for the outcome were pain at initial examination (p=0.030) and other clinical signs or symptoms at initial examination (p=0.042), meaning that such teeth had lower healing rates 1 year after periapical surgery compared with teeth without such signs or symptoms. Logistic regression revealed that pain at initial examination (odds ratio=2.59, confidence interval=1.2-5.6, p=0.04) was the only predictor reaching significance. Several predictors almost reached statistical significance: lesion size (p=0.06), retrofilling material (p=0.06), and postoperative healing course (p=0.06).

Measurement of dental implant stability by resonance frequency analysis and damping capacity assessment: comparison of both techniques in a clinical trial

PURPOSE: Two noninvasive methods to measure dental implant stability are damping capacity assessment (Periotest) and resonance frequency analysis (Osstell). The objective of the present study was to assess the correlation of these 2 techniques in clinical use. MATERIALS AND METHODS: Implant stability of 213 clinically stable loaded and unloaded 1-stage implants in 65 patients was measured in triplicate by means of resonance frequency analysis and Periotest. Descriptive statistics as well as Pearson's, Spearman's, and intraclass correlation coefficients were calculated with SPSS 11.0.2. RESULTS: The mean values were 57.66 +/- 8.19 implant stability quotient for the resonance frequency analysis and -5.08 +/- 2.02 for the Periotest. The correlation of both measuring techniques was -0.64 (Pearson) and -0.65 (Spearman). The single-measure intraclass correlation coefficients for the ISQ and Periotest values were 0.99 and 0.88, respectively (95% CI). No significant correlation of implant length with either resonance frequency analysis or Periotest could be found. However, a significant correlation of implant diameter with both techniques was found (P < .005). The correlation of both measuring systems is moderate to good. It seems that the Periotest is more susceptible to clinical measurement variables than the Osstell device. The intraclass correlation indicated lower measurement precision for the Periotest technique. Additionally, the Periotest values differed more from the normal (Gaussian) curve of distribution than the ISQs. Both measurement techniques show a significant correlation to the implant diameter. CONCLUSION: Resonance frequency analysis appeared to be the more precise technique.

Individual versus standard quality of life assessment in a phase II clinical trial in mesothelioma patients: feasibility and responsiveness to clinical changes

In patients with malignant pleural mesothelioma undergoing a multimodality therapy, treatment toxicity may outweigh the benefit of progression-free survival. The subjective experience across different treatment phases is an important clinical outcome. This study compares a standard with an individual quality of life (QoL) measure used in a multi-center phase II trial.

Further concerns about self-assessment: are medical students aware of their progress in clinical skills during clerkship

Background: Medical students do not accurately self-assess their competence. However, little is known about the awareness of change of competence over time. The aim of this study was to evaluate if students are aware of their progress. Summary of work: Twenty-two fourth year medical students had self- and expert-assessments of their clinical skills in musculoskeletal medicine in an OSCE like station (4 point Likert scale) at the beginning (t0) and end (t1) of their eight weeks clerkship in internal medicine. Thirteen students were assigned to the intervention of a 6x1 hour practical examination course; nine took part in the regular clinical clerkship activities only and served as controls. Summary of results/Conclusions: The intervention students significantly improved their skills (from 2.78 ± 0.36 to 3.30 ± 0.36, p<0.05) in contrast to the control students (from 3.11 ± 0.58 to 2.83 ± 0.49, n.s.). At t0, 19 students, at t1 21 out of 22 students underestimated their competence. Correlations between the change of self- and expert-assessment were r=0.43, p<0.05 (all), r=0.47, n.s. (control) and r=-0.12, n.s. (intervention), respectively. Take-home message: Medical students improving their clinical skills by an interactive course in addition to their regular clerkship activities are not aware of their progress

The SAKK cancer-specific geriatric assessment (C-SGA): a pilot study of a brief tool for clinical decision-making in older cancer patients

BACKGROUND Recommendations from international task forces on geriatric assessment emphasize the need for research including validation of cancer-specific geriatric assessment (C-SGA) tools in oncological settings. The objective of this study was to evaluate the feasibility of the SAKK Cancer-Specific Geriatric Assessment (C-SGA) in clinical practice. METHODS A cross sectional study of cancer patients >=65 years old (N = 51) with pathologically confirmed cancer presenting for initiation of chemotherapy treatment (07/01/2009-03/31/2011) at two oncology departments in Swiss canton hospitals: Kantonsspital Graubunden (KSGR N = 25), Kantonsspital St. Gallen (KSSG N = 26). Data was collected using three instruments, the SAKK C-SGA plus physician and patient evaluation forms. The SAKK C-SGA includes six measures covering five geriatric assessment domains (comorbidity, function, psychosocial, nutrition, cognition) using a mix of medical record abstraction (MRA) and patient interview. Five individual domains and one overall SAKK C-SGA score were calculated and dichotomized as below/above literature-based cut-offs. The SAKK C-SGA was evaluated by: patient and physician estimated time to complete, ease of completing, and difficult or unanswered questions. RESULTS Time to complete the patient questionnaire was considered acceptable by almost all (>=96%) patients and physicians. Patients reported slightly shorter times to complete the questionnaire than physicians (17.33 +/- 7.34 vs. 20.59 +/- 6.53 minutes, p = 0.02). Both groups rated the patient questionnaire as easy/fairly easy to complete (91% vs. 84% respectively, p = 0.14) with few difficult or unanswered questions. The MRA took on average 8.32 +/- 4.72 minutes to complete. Physicians (100%) considered time to complete MRA acceptable, 96% rated it as easy/fairly easy to complete. Individual study site populations differed on health-related characteristics (excellent/good physician-rated general health KSGR 71% vs. KSSG 32%, p = 0.007). The overall mean C-SGA score was 2.4 +/- 1.12. Patients at KSGR had lower C-SGA scores (2.00 +/- 1.19 vs. 2.81 +/- 0.90, p = 0.009) and a smaller proportion (28% vs.65%, p = 0.008) was above the C-SGA cut-off score compared to KSSG. CONCLUSIONS These results suggest the SAKK C-SGA is a feasible practical tool for use in clinical practice. It demonstrated discriminative ability based on objective geriatric assessment measures, but additional investigations on use for clinical decision-making are warranted. The SAKK C-SGA also provides important usable domain information for intervention to optimize outcomes in older cancer patients.

Psychoendocrine validation of a short measure for assessment of perceived stress management skills in different non-clinical populations

BACKGROUND: We investigated the psychometric properties of a short questionnaire for combined assessment of different perceived stress management skills in the general population and tested whether scores relate to physiological stress reactivity. METHODS: For psychometric evaluation, we determined the factor structure of the questionnaire and investigated its measurement invariance in the participant groups and over time in three different independent samples representing the general population (total N=332). Reliability was tested by estimating test-retest reliability, internal consistency, and item reliabilities. We examined convergent and criterion validity using selected criterion variables. For endocrine validation, 35 healthy non-smoking and medication-free men in a laboratory study and 35 male and female employees in a workplace study underwent an acute standardized psychosocial stress task. We assessed stress management skills and measured salivary cortisol before and several times up to 60 min (workplace study) and 120 min (laboratory study) after stress. Potential confounders were controlled. RESULTS: The factor structure of the questionnaire consists of five scales reflecting acceptably distinct stress management skills such as cognitive strategies, use of social support, relaxation strategies, anger regulation, and perception of bodily tension. This factor structure was stable across participant groups and over time. Internal consistencies, item reliabilities, and test-retest reliabilities met established statistical requirements. Convergent and criterion validity were also established. In both endocrine validation studies, higher stress management skills were independently associated with lower cortisol stress reactivity (p's<.029). CONCLUSIONS: Our findings suggest that the questionnaire has good psychometric properties and that it relates to subjective psychological and objective physiological stress indicators. Therefore, the instrument seems a suitable measure for differential assessment of stress management skills in the general population.