Development and validation of an automated thawing and mixing workcell

Journal ArticleWorking toward a goal of total laboratory automation, we are automating manual activities in our highest volume laboratory section. Because half of all specimens arriving in this laboratory section are frozen, we began by developing an automated workcell for thawing frozen specimens and mixing the thawed specimens to remove concentration gradients resulting from freezing and thawing

Unstated factors in orthopaedic decision-making: a qualitative study

<p>Abstract</p> <p>Background</p> <p>Total joint replacement (TJR) of the hip or knee for osteoarthritis is among the most common elective surgical procedures. There is some inequity in provision of TJR. How decisions are made about who will have surgery may contribute to disparities in provision. The model of shared decision-making between patients and clinicians is advocated as an ideal by national bodies and guidelines. However, we do not know what happens within orthopaedic practice and whether this reflects the shared model. Our study examined how decisions are made about TJR in orthopaedic consultations.</p> <p>Methods</p> <p>The study used a qualitative research design comprising semi-structured interviews and observations. Participants were recruited from three hospital sites and provided their time free of charge. Seven clinicians involved in decision-making about TJR were approached to take part in the study, and six agreed to do so. Seventy-seven patients due to see these clinicians about TJR were approached to take part and 26 agreed to do so. The patients' outpatient appointments ('consultations') were observed and audio-recorded. Subsequent interviews with patients and clinicians examined decisions that were made at the appointments. Data were analysed using thematic analysis.</p> <p>Results</p> <p>Clinical and lifestyle factors were central components of the decision-making process. In addition, the roles that patients assigned to clinicians were key, as were communication styles. Patients saw clinicians as occupying expert roles and they deferred to clinicians' expertise. There was evidence that patients modified their behaviour within consultations to complement that of clinicians. Clinicians acknowledged the complexity of decision-making and provided descriptions of their own decision-making and communication styles. Patients and clinicians were aware of the use of clinical and lifestyle factors in decision-making and agreed in their description of clinicians' styles. Decisions were usually reached during consultations, but patients and clinicians sometimes said that treatment decisions had been made beforehand. Some patients expressed surprise about the decisions made in their consultations, but this did not necessarily imply dissatisfaction.</p> <p>Conclusions</p> <p>The way in which roles and communication are played out in decision-making for TJR may affect the opportunity for shared decisions. This may contribute to variation in the provision of TJR. Making the importance of these factors explicit and highlighting the existence of patients' 'surprise' about consultation outcomes could empower patients within the decision-making process and enhance communication in orthopaedic consultations.</p

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Challenges and Opportunities in Implementing Total Laboratory Automation

In total laboratory automation (TLA), preanalytic, analytic, and postanalytic phases of laboratory testing may be combined into an integrated system such that specimens are processed, tested, and even stored with minimal user intervention. Given the pressures of an ongoing workforce shortage of laboratory professionals, laboratory automation offers an attractive, albeit expensive, solution that laboratories are increasingly considering in planning for future growth and work flow requirements. In an ideal system, TLA handles routine, repetitive steps\u2014leveraging the quality and efficiency obtainable in the manufacturing industry and freeing operators to focus on specialized testing that benefits from their unique training and expertise. A variety of laboratory automation solutions have been available globally for decades, with technologies that have advanced based on engineering innovation and practical trial and error. To address the difficulties and benefits involved in implementing and sustaining TLA in a clinical laboratory setting, we invited a group of 5 experts to share their perspectives on laboratory automation and provide real-world advice based on their experiences with TLA at their respective facilities

Symptom Assessment in Knee Osteoarthritis Needs to Account for Physical Activity Level

ObjectivePain is not always correlated with severity of radiographic osteoarthritis (OA), possibly because people modify activities to manage symptoms. Measures of symptoms that consider pain in the context of activity level may therefore provide greater discrimination than a measure of pain alone. We undertook this study to compare discrimination provided by a measure of pain alone with that provided by combined measures of pain in the context of physical activity across radiographic OA severity levels.MethodsThis was a cross-sectional study nested within the Osteoarthritis Initiative (OAI). The population was drawn from 2,127 persons enrolled in an OAI accelerometer monitoring substudy, including those with and those without knee OA. Two composite pain and activity knee symptom (PAKS) scores were calculated as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score (plus 1) divided by a physical activity measure (step count for the first PAKS score [PAKS1 score] and activity count for the second PAKS score [PAKS2 score]). Symptom score discrimination across Kellgren/Lawrence (K/L) grades was evaluated using histograms and quantile regression.ResultsA total of 1,806 participants (55.5% of whom were women) were included (mean ± SD age 65.1 ± 9.1 years, mean ± SD body mass index 28.4 ± 4.8 kg/m(2) ). The WOMAC pain score, but not the PAKS scores, exhibited a floor effect. The adjusted median WOMAC pain scores by K/L grades 0-4 were 0, 0, 0, 1, and 3, respectively. The adjusted median PAKS1 scores were 24.9, 26.0, 32.4, 46.1, and 97.9, respectively, and the adjusted median PAKS2 scores were 7.2, 7.2, 9.2, 12.9, and 23.8, respectively. The PAKS scores had more statistically significant comparisons between K/L grades than did the WOMAC pain score.ConclusionSymptom assessments incorporating pain and physical activity did not exhibit a floor effect and were better able to discriminate radiographic severity than an assessment of pain alone, particularly in milder disease. Pain in the context of physical activity level should be used to assess knee OA symptoms

Validation of a new symptom outcome for knee osteoarthritis: the Ambulation Adjusted Score for Knee pain

ObjectiveValidation of a symptom measure for early knee OA may help identify new treatments and modifiable risk factors. Symptom measures that consider pain in the context of activity level may provide better discrimination than pain alone. Therefore, we aimed to compare sensitivity to change for radiographic progression between Ambulation Adjusted Score for Knee pain (AASK), which accounts for self-reported ambulation, and Western Ontario McMaster Osteoarthritis (WOMAC) knee pain score.DesignParticipants were assessed annually up to 48&nbsp;months using WOMAC, Physical Activity Scale for the Elderly (PASE) ambulation, and knee radiographs. AASK was defined as ((WOMAC pain) + 1)/((average daily hours of walking) + 1). Radiographs were scored for Kellgren-Lawrence (KL) grade. Linear regression, stratified by OA status, evaluated relationships between changes in AASK and WOMAC pain and KL grade over time.ResultsFor 4191 people (8030 knees), the mean age was 61.2 (+ 9.2) years old and BMI was 28.6 (+ 4.8) kg/m2; 58% female. Over 40% of knees had WOMAC pain scores of 0; by design, no knees had AASK scores of 0. Annual changes in AASK were more sensitive to changes in KL than changes in WOMAC in those without baseline OA (0.20 and 0.16 change per unit KL change, p = 0.005 and 0.070 respectively), but performed similarly in knees with OA.ConclusionAASK is simple to assess using existing validated questionnaires. AASK performs well in individuals with and without OA and should be considered in clinical trials and observational studies of early knee OA