Quality specifications: self pleasure for clinical laboratories or added value for patient management?

Author(s):  
Mario Plebani

AbstractAnalytical quality specifications play a key role in assuring and continuously improving high-quality laboratory services. However, I believe, that there are two “missing links” in the effective management of quality specifications in the delivery of laboratory services. The first is the evidence that pre-analytical variation and related problems are not taken into great consideration by laboratory professionals. The second missing link is the communication of quality specifications to clinicians and other possible stakeholders. If quality specifications represent “the level of performance required to facilitate clinical decision-making”, they cannot be used only for internal quality management procedures but must be communicated to facilitate clinical reasoning, decision-making and patient management. A consensus should be achieved in the scientific community on these issues to assure better utilization of laboratory data and, ultimately, improved clinical outcomes.Clin Chem Lab Med 2007;45:462–6.


2018 ◽  
Vol 43 (2) ◽  
pp. 559-566 ◽  
Author(s):  
T. A. K. Gandamihardja ◽  
T. Soukup ◽  
S. McInerney ◽  
J. S. A. Green ◽  
N. Sevdalis


2021 ◽  
Vol 108 (Supplement_4) ◽  
Author(s):  
M Ramser ◽  
D Cadosch ◽  
W Vach ◽  
F Saxer ◽  
H Eckardt

Abstract Objective Pelvic ring fractures in the elderly with osteoporotic bone are often caused by a minor trauma. A separate classification for these fragility fractures of the pelvis (FFP) has been proposed by Rommens. However, at our institution the management algorithm is rather based on patient profile, clinical course and the ability to mobilize than on the fracture category. We aimed to identify fracture characteristics that might better reflect clinical decision making and show an association with outcome. Methods Four fracture characteristics were investigated as potential variables: 1. Extent of the dorsal pelvic ring fracture (absent, unilateral, bilateral); 2. Extent of the ventral pelvic ring fracture (absent, unilateral, bilateral); 3. Ventral comminution/dislocation; 4. Presence of a horizontal sacral fracture. These four characteristics were assessed retrospectively in a series of 548 patients with a CT scan proven FFP. The association of the fracture morphology with the decision to perform surgery, failure of conservative treatment and the length of hospital stay (LOS) was determined. Results Three of the four evaluated characteristics showed an independent and significant association with clinical decision making and patient management. In particular the extent of the dorsal fractures was identified as an independent risk factor for the decision to perform surgery with a 7.3-fold increase per category (p < 0.001). The same was observed for the presence of ventral comminution/dislocation (OR = 2.4; p = 0.002). The extent of ventral fractures (OR = 1.5; p = 0.047) was an independent risk factor for a longer LOS in conservatively treated patients. Conclusion Three evaluated morphologic aspects of FFPs showed a clear and independent relation to current clinical decision making and patient management at our institution. Importantly, the ventral fracture component has been shown to have major impact on treatment decision and outcome, which has been underestimated in the current FFP classification system. These four easily distinguishable fracture characteristics have the potential to form the basis of an alternative classification system that matches clinical reality and captures prognostic aspects.



2014 ◽  
Vol 94 (1) ◽  
pp. 1-24 ◽  
Author(s):  
Bernd J. Schmitz-Dräger ◽  
Michael Droller ◽  
Vinata B. Lokeshwar ◽  
Yair Lotan ◽  
M''Liss A. Hudson ◽  
...  

Due to the lack of disease-specific symptoms, diagnosis and follow-up of bladder cancer has remained a challenge to the urologic community. Cystoscopy, commonly accepted as a gold standard for the detection of bladder cancer, is invasive and relatively expensive, while urine cytology is of limited value specifically in low-grade disease. Over the last decades, numerous molecular assays for the diagnosis of urothelial cancer have been developed and investigated with regard to their clinical use. However, although all of these assays have been shown to have superior sensitivity as compared to urine cytology, none of them has been included in clinical guidelines. The key reason for this situation is that none of the assays has been included into clinical decision-making so far. We reviewed the current status and performance of modern molecular urine tests following systematic analysis of the value and limitations of commercially available assays. Despite considerable advances in recent years, the authors feel that at this stage the added value of molecular markers for the diagnosis of urothelial tumors has not yet been identified. Current data suggest that some of these markers may have the potential to play a role in screening and surveillance of bladder cancer. Well-designed protocols and prospective, controlled trials will be needed to provide the basis to determine whether integration of molecular markers into clinical decision-making will be of value in the future.



2018 ◽  
Vol 27 (4) ◽  
pp. 391-397 ◽  
Author(s):  
Akos Ilias ◽  
Barbara D Lovasz ◽  
Lorant Gonczi ◽  
Zsuzsanna Kurti ◽  
Zsuzsanna Vegh ◽  
...  

Background & Aims: Rapid optimization of treatment algorithms and disease outcomes requires an objective measurement of disease activity in patients with Crohn’s disease (CD). Our aim was to evaluate the impact of rapid-access to magnetic resonance imaging (MRI) on treatment optimization, clinical decision-making and outcomes for CD patients in a specialized tertiary care for inflammatory bowel disease (IBD) patients.Methods: A cohort of 75 referral CD patients (median age: 34, IQR: 25-43 years) who had underwent 90 fasttrack MR enterography (MRE) scans between January 2014 and June 2016 were retrospectively enrolled. The MRI results were compared to clinical activity scores and biomarkers (C-reactive protein). The immediate impact of fast-track MRI on clinical decision-making, including changes in medical therapy, the need of hospitalization and surgery were evaluated.Results: The location of CD was ileo-colonic in 61% of the patients with perianal fistulas in 56% and previous surgeries in 55%. The indication for fast-track MRI scans was active disease (clinical or biomarker activity) in 55.6%. The radiological activity (including mild radiological signs to severe lesions) was detected in 94% of cases. Significant/severe MRI activity was depicted in 68% of these patients. Correlation between MRI radiological activity and clinical disease activity or colonoscopy was moderate (kappa: 0.609 and 0.652). A change in therapeutic strategy was made in 94.1% of cases with severe MRI radiological activity vs. 50% of patients without severe MRI radiological activity (p=0.001). Significant/severe MRI activity was followed by higher surgery rates among patients with clinical disease activity (50% vs. 12.5%; p=0.013). MRI performed on patients with clinical and biomarker remission identified disease activity in a significantly smaller proportion.Conclusions: Fast-track MRI had a great impact on patient management in CD patients with clinical or biomarker activity, leading to better patient stratification and faster optimization of the therapy (medical or surgical), while MRI revealed previously undiagnosed disease activity only in a small proportion of patients in clinical remission.



2021 ◽  
pp. 115-140
Author(s):  
D. A. Janeera ◽  
G. Jims John Wesley ◽  
P. Rajalakshmy ◽  
S. Shalini Packiam Kamala ◽  
P. Subha Hency Jose ◽  
...  


2010 ◽  
Vol 15 (Suppl 3) ◽  
pp. 45-51 ◽  
Author(s):  
Robert Perrillo ◽  
Jinlin Hou ◽  
George Papatheodoridis ◽  
Michael Manns


1975 ◽  
Vol 14 (03) ◽  
pp. 113-117 ◽  
Author(s):  
J. Sebag ◽  
P. Hall

A method designed to aid clinical decision-making is described. Predictors and Indicators are criteria that reflect the likelihood of disease and health, based on a retrospective analysis of the frequencies of diseases or diagnoses associated with symptoms, signs, and tests (SST’s). The approach is primarily based upon the SST’s of an individual and how these vary over time. This differs from traditional approaches which operate primarily from a disease-or diagnostic-oriented perspective. Such approaches are, therefore, useful in areas of medical research, education, and paraclinical service units, but have a limited value for patient-care. Static and dynamic health indices aid clinical decision-making by summarizing the SST-oriented Predictor and Indicator evaluations into individualized indices that can be monitored over time.The methodology of employing this approach for the evaluation of laboratory data is presented. The application of these techniques to a battery of laboratory tests will be presented in the near future.





2019 ◽  
Vol 27 (1) ◽  
Author(s):  
Michael Hobbs ◽  
Dirk Crafford ◽  
Katherine MacRae ◽  
Anneliese Hulme ◽  
Stephney Whillier ◽  
...  

Abstract Background The process of developing patient management plans requires a series of clinical decision-making skills that can take years in practice to develop. For the inexperienced practitioner, providing a logical, systematic patient management framework may assist in clinical scenarios and accelerate their decision-making skill development. The purpose of this study was to assess whether a novel clinical management decision aid would improve the management decision-making of chiropractic students. Methods A prospective before and after study tracked chiropractic master degree students in their final year of study across a 10-week period from February–May, 2017. Case-based assessments were performed at baseline, after initial exposure to the decision aid, and after repeated exposure over the course of the semester. Outcome measures included the results from the 3 assessments, scored out of 20 by two markers using a standardised marking rubric, then averaged and converted to percentages; and 2 feedback questionnaires, given after initial exposure and at 10 weeks. Results A total of 75 students (44 males; 31 females) participated in the study. The mean score at baseline was 8.34/20 (41.7%) (95% CI: 7.98, 8.70; SD: 1.56) and after initial exposure was 9.52/20 (47.6%) (95% CI: 9.06, 9.98; SD: 2.02). The mean score after repeated exposure was 15.04/20 (75.2%) (95% CI: 14.46, 15.62; SD: 2.54). From baseline to initial exposure, there was a statistically significant absolute increase in mean score of 1.18/20 (5.9%) (95% CI: 0.6, 1.76; p < 0.0001), or a 2.82/20 (14.1%) relative improvement. From baseline to repeated exposure, there was a statistically significant absolute increase in mean score of 6.7/20 (33.5%) (95% CI: 6.02, 7.38; p < 0.0001), or a 16.06/20 (80.3%) relative improvement. The questionnaire results were also favourable. 56/75 (75%) participants agreed that the decision aid was easy to use and 46/75 (61%) of participants agreed that the decision aid improved their ability to integrate various management techniques. Conclusion Implementing a clinical management decision aid into the teaching curriculum helped to facilitate the ability of chiropractic students to develop patient management plans.



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