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Blue-green neutrophilic inclusions (BGNI), also known as "death bodies," are bright green structures observed in the cytoplasm of neutrophils or monocytes and are closely associated with acute liver failure, lactic acidosis, and other serious diseases. Some studies suggested a potential association with phagocytic lipofuscin released by damaged liver cells. The presence of BGNI typically indicated a poor prognosis. We presented two cases. Case 1 was diagnosed with novel bunyavirus infection and exhibited severe hepatic impairment and coagulation dysfunction along with the presence of BGNI in neutrophils. Despite receiving comprehensive symptomatic treatment, the patient's condition rapidly deteriorated leading to eventual demise. Case 2 had severe liver injury caused by wasp stings, and BGNI was observed. Following active treatment measures, the patient eventually achieved recovery. Throughout the disease course of case 1, there was a progressive deepening in color and increase in quantity of BGNI. Conversely, case 2 demonstrated an opposite trend. Based on the comparison of clinical outcomes and variations in color and quantity of BGNI between these two patients, it was found that an increase in the number and deepening of BGNI color corresponded to worsening condition. Conversely, a decrease in quantity and lightening of color indicated improvement. Hence, these findings suggest a possible association between changes in BGNI characteristics and prognosis. [ABSTRACT FROM AUTHOR]

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To determine how life satisfaction changes across the first 10 years following traumatic brain injury (TBI). Participants included 1,941 individuals from the TBI Model Systems database with life satisfaction data at 1-, 5-, and 10-years post-TBI. Based on Satisfaction With Life Scale scores, individuals were characterized as having one of the five 10-year life satisfaction trajectories: 'Stable High,' 'Stable Low,' 'Increased to High,' 'Decreased to Low,' and 'Unstable.' These were analyzed for group differences in demographics and psychosocial and functional outcomes. Sixty percent participants had 'Stable High' or 'Increasing to High' trajectories. Approximately 25% had "Stable Low' or 'Decreasing to Low' trajectories, and approximately 15% had unstable trajectories. Higher life satisfaction trajectories were associated with the best psychosocial and functional outcomes whereas lower trajectories were associated with the worst psychosocial and functional outcomes. Trajectories were indistinguishable based on demographics. Life satisfaction over the first 10 years following TBI is dynamic, with most individuals reporting high life satisfaction by 10 years post-TBI. Examination of psychosocial and functional factors related to life satisfaction trajectories may inform community-based intervention recommendations, resources, and supports to maximize long-term satisfaction with life. [ABSTRACT FROM AUTHOR]

Treatment success is the desired outcome in aphasia rehabilitation. However, to date, there is a lack of consensus on what defines a 'successful' result on a given aphasia outcome measurement instrument (OMI). In this methodological paper, we present strategies for how to define and measure treatment success on a given OMI at the group-level, as well as for an individual person with aphasia. The latter is particularly important when research findings from group studies are clinically implemented for individuals in rehabilitation. We start by presenting methods to calculate the average statistically significant change across several (group) studies (e.g., standardised mean difference, raw unstandardised mean difference) for a given OMI. Such metrics are useful to summarise the overall effect of the intervention of interest, particularly in meta-analyses. However, benchmarks based on group effects are not feasible for assessing an individual participant's treatment success and thus for determining the proportion of patients who had a beneficial response to therapy (overall response rate of an intervention). We therefore recommend a distribution-based approach to determine benchmarks of a statistically significant treatment response at the individual level, i.e., the 'smallest detectable change' for a given OMI, which refers to the smallest change that can be detected by the OMI beyond measurement error. However, the statistical significance of an individual treatment effect does not necessarily correspond to its clinical impact. This requires an additional indicator. The benchmark to determine a clinically relevant improvement on a given OMI is the 'minimal important change'. The minimally important change is defined as the smallest OMI change score perceived as important by the relevant stakeholder group (i.e., people with aphasia, their relatives/caregivers, clinicians). It therefore requires relating the individual OMI change scores to 'anchors', i.e., meaningful external criteria, preferably based on patient-perceived therapy success. Currently, there is no consensus regarding the optimal 'anchors' and their respective definition of clinically important change in aphasia outcome research. Operationalising individual treatment success based on both statistically significant and (patient-reported) clinically meaningful benchmarks is a key priority in aphasia rehabilitation. Availability of such measures will (a) facilitate estimates of therapy response rate in intervention studies and thus optimise therapeutic decisions and (b) provide stakeholder groups (e.g., the society, the stroke team, people with aphasia, family, clinicians, healthcare professionals) with objective, statistically reliable and meaningful feedback on individual treatment response in the clinical setting. [ABSTRACT FROM AUTHOR]

Objective: To identify demographic, injury-related, and 1-year postinjury clinical and functional predictors of high and low life satisfaction at 10 years after moderate to severe traumatic brain injury (TBI) using an extreme phenotyping approach. Setting: Multicenter longitudinal database study. Participants: A total of 3040 people from the National Institute on Disability, Independent Living, and Rehabilitation Research TBI Model Systems database with life satisfaction data at 10 years post-TBI. Design: Multicenter, cross-sectional, observational design. Main Measures: Satisfaction With Life Scale (outcome), Glasgow Coma Scale, Disability Rating Scale, Functional Independence Measure, Participation Assessment with Recombined Tools-Objective, Patient Health Questionnaire-9, and General Anxiety Disorder-7 (standardized predictors). Results: Greater cognitive and motor independence, more frequent community participation, and less depressive symptoms 1 year post-moderate to severe TBI predicted extreme high life satisfaction 10 years later. Non-Hispanic White and Hispanic individuals were significantly more likely than Black individuals to have extreme high life satisfaction 10 years post-TBI. Conclusions: Extreme phenotyping analysis complements existing knowledge regarding life satisfaction post-moderate to severe TBI. From a chronic disease management perspective, future studies are needed to examine the feasibility and impact of early postinjury medical and rehabilitative interventions targeting cognitive and motor function, community participation, and mood on the maintenance/enhancement of long-term life satisfaction post-TBI. [ABSTRACT FROM AUTHOR]

Assessments of treatments for 'subjective symptoms' are problematic and potentially contentious. These are symptoms without ascertainable pathophysiology, also referred to as 'medically unexplained.' Treatments of them may be assessed from different perspectives, and an assessment as seen from one perspective may be discrepant with an assessment as seen from another perspective. The observational study described in the paper represents one perspective. Patients in the study were treated with acupuncture for the subjective symptom of low back pain in a Traditional Chinese Medicine Clinic in China; acupuncture is a form of TCM, which is indigenous to China. Shortly after treatment began and six months afterward, patients reported 'clinically important improvements' on a variety of standard, cross‐culturally validated outcome measures, including pain intensity, physical functioning, and emotional functioning; this assessment is consistent with numerous assessments of acupuncture in China and other Southeastern Asian countries. On the other hand, clinical trials represent another perspective from which to assess acupuncture. Although assessments based on trials are not uniform, several assessments based on them, including those published in journals such as Lancet and New England Journal of Medicine, conclude that acupuncture is not effective. These trials, however, were mainly situated in the U.S., western European countries, and other WEIRD (Western, Educated, Industrialized, Rich, Democratic) countries. This is notable, because the population of China, the indigenous context of acupuncture, is greater than populations of WEIRD countries combined. Patients' expectations of a treatment such as acupuncture and their prior familiarity with it vary among contexts, and patients' experiences of treatment outcomes may vary accordingly. In short, although clinical trials constitute a test of truth in biomedicine and inform authoritative assessments in WEIRD countries, they do not necessarily represent the truth from the perspective of those experiencing outcomes of especially indigenous treatments for subjective symptoms in non‐WEIRD contexts. [ABSTRACT FROM AUTHOR]

Objective: To analyze whether other outcome measures used in health technology assessment (HTA) address the criticisms of quality‐adjusted life years (QALYs). Data Sources and Study Setting: HTA methods guidance from 11 US comparator countries (the G10 and Australia) and six value frameworks from US organizations were reviewed to identify health outcome measures currently used to evaluate the benefits of a drug. Study Design: The study involved a documentary analysis of guidelines to identify outcome measures used by the sampled HTA organizations. Similar outcomes were grouped together into outcome types. Each type was analyzed to determine the extent to which it replicates key advantages and responds to criticisms of QALYs extracted from the literature. Extraction Methods: Outcomes were included if guidance from at least one HTA organization identified the outcome as acceptable for HTA. Outcomes measuring or evaluating the benefit, clinical effect, or impact of a drug or health technology was included; methods of calculating costs were excluded. Principal Findings: Seven types of outcome measures were identified falling into three groups: preference‐based, single‐dimension outcomes, and outcomes using non‐health perspectives. Among the seven QALY alternative outcome measures currently used for HTA by the sampled countries, no one outcome measure addresses all the QALY criticisms while retaining the advantageous features of the QALY. Conclusions: Proposals to adopt health technology assessment (HTA) to support value‐based pricing of prescription drugs in the US have faced pushback over the use of the QALY. There is no single "right" outcome measure, and the criticisms of QALYs apply to other outcome measures used to evaluate health. The measures identified have different features and strengths, which may be appropriate for specific decision making goals, but the QALY remains the best option for decision making that requires comparisons of the overall societal value of health gains. [ABSTRACT FROM AUTHOR]

Abstract Background To be able to make informed choices based on their individual preferences, patients need to be adequately informed about treatment options and their potential outcomes. This implies that studies measure the effects of care based on parameters that are relevant to patients. In a previous scoping review, we found a wide variety of supposedly patient-relevant parameters that equally addressed processes and outcomes of care. We were unable to identify a consistent understanding of patient relevance and therefore aimed to develop an empirically based concept including a generic set of patient-relevant parameters. As a first step we evaluated the process and outcome parameters identified in the scoping review from the patients’ perspective. Methods We conducted a cross-sectional survey among German general practice patients. Ten research practices of Witten/Herdecke University supported the study. During a two-week period in the fall of 2020, patients willing to participate self-administered a short questionnaire. It evaluated the relevance of the 32 parameters identified in the scoping review on a 5-point Likert scale and offered a free-text field for additional parameters. These free-text answers were inductively categorized by two researchers. Quantitative data were analyzed using descriptive statistics. Bivariate analyses were performed to determine whether there are any correlations between rating a parameter as highly relevant and patients’ characteristics. Results Data from 299 patients were eligible for analysis. All outcomes except ‘sexuality’ and ‘frequency of healthcare service utilization’ were rated important. ‘Confidence in therapy’ was rated most important, followed by ‘prevention of comorbidity’ and ‘mobility’. Relevance ratings of five parameters were associated with patients’ age and gender, but not with their chronic status. The free-text analysis revealed 15 additional parameters, 12 of which addressed processes of care, i.e., ‘enough time in physician consultation’. Conclusion Patients attach great value to parameters addressing processes of care. It appears as though the way in which patients experience the care process is not less relevant than what comes of it. Relevance ratings were not associated with chronic status, but few parameters were gender- and age-related. Trial registration Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1685.

The aim of this research was to develop a quantitative method for clinicians to predict the probability of improved prognosis in patients with coronavirus disease 2019 (COVID-19). Data on 104 patients admitted to hospital with laboratory-confirmed COVID-19 infection from 10 January 2020 to 26 February 2020 were collected. Clinical information and laboratory findings were collected and compared between the outcomes of improved patients and non-improved patients. The least absolute shrinkage and selection operator (LASSO) logistics regression model and two-way stepwise strategy in the multivariate logistics regression model were used to select prognostic factors for predicting clinical outcomes in COVID-19 patients. The concordance index (C-index) was used to assess the discrimination of the model, and internal validation was performed through bootstrap resampling. A novel predictive nomogram was constructed by incorporating these features. Of the 104 patients included in the study (median age 55 years), 75 (72.1%) had improved short-term outcomes, while 29 (27.9%) showed no signs of improvement. There were numerous differences in clinical characteristics and laboratory findings between patients with improved outcomes and patients without improved outcomes. After a multi-step screening process, prognostic factors were selected and incorporated into the nomogram construction, including immunoglobulin A (IgA), C-reactive protein (CRP), creatine kinase (CK), acute physiology and chronic health evaluation II (APACHE II), and interaction between CK and APACHE II. The C-index of our model was 0.962 (95% confidence interval (CI), 0.931–0.993) and still reached a high value of 0.948 through bootstrapping validation. A predictive nomogram we further established showed close performance compared with the ideal model on the calibration plot and was clinically practical according to the decision curve and clinical impact curve. The nomogram we constructed is useful for clinicians to predict improved clinical outcome probability for each COVID-19 patient, which may facilitate personalized counselling and treatment.

To identify correlates of life satisfaction at 10 years after moderate to severe traumatic brain injury (TBI) using an extreme phenotyping approach. Effect sizes were calculated in this observational cohort study to estimate relationships of 10-year postinjury extremely high, extremely low, and moderate life satisfaction with (1) pre-injury demographics, injury-related factors, and functional characteristics at inpatient rehabilitation admission and discharge; and (2) postinjury demographics and clinical and functional measures at 10 years postinjury. Multicenter longitudinal database study. People identified from the National Institute on Disability, Independent Living, and Rehabilitation Research TBI Database with life satisfaction data at 10 years post TBI (N=4800). Not applicable. Satisfaction With Life Scale. Although few pre-injury factors or clinical and functional factors shortly after injury were associated with 10-year life satisfaction groups, the following 10-year postinjury factors were associated with extremely high vs extremely low life satisfaction group membership: greater independent functioning, less disability, more frequent community participation, being employed, and having fewer depressive and anxiety symptoms. Those with extremely high life satisfaction were distinctly different from those with moderate and extremely low satisfaction. Extremely high life satisfaction was underrepresented among non-Hispanic Black persons relative to non-Hispanic White persons. Relationships between life satisfaction and independent functioning, disability, and participation were attenuated among non-Hispanic Black persons. Extreme phenotyping analysis complements existing knowledge regarding life satisfaction after moderate to severe TBI and may inform acute and postacute clinical service delivery by comparing extremely high and extremely low life satisfaction subgroups. Findings suggest little association among personal, clinical, and functional characteristics early post TBI and life satisfaction 10 years later. Contemporaneous correlates of extremely high life satisfaction exist at 10 years post TBI, although the positive relationship of these variables to life satisfaction may be attenuated for non-Hispanic Black persons. [ABSTRACT FROM AUTHOR]

Blue-green neutrophilic inclusions (BGNI), also known as "death bodies," are bright green structures observed in the cytoplasm of neutrophils or monocytes and are closely associated with acute liver failure, lactic acidosis, and other serious diseases. Some studies suggested a potential association with phagocytic lipofuscin released by damaged liver cells. The presence of BGNI typically indicated a poor prognosis. We presented two cases. Case 1 was diagnosed with novel bunyavirus infection and exhibited severe hepatic impairment and coagulation dysfunction along with the presence of BGNI in neutrophils. Despite receiving comprehensive symptomatic treatment, the patient's condition rapidly deteriorated leading to eventual demise. Case 2 had severe liver injury caused by wasp stings, and BGNI was observed. Following active treatment measures, the patient eventually achieved recovery. Throughout the disease course of case 1, there was a progressive deepening in color and increase in quantity of BGNI. Conversely, case 2 demonstrated an opposite trend. Based on the comparison of clinical outcomes and variations in color and quantity of BGNI between these two patients, it was found that an increase in the number and deepening of BGNI color corresponded to worsening condition. Conversely, a decrease in quantity and lightening of color indicated improvement. Hence, these findings suggest a possible association between changes in BGNI characteristics and prognosis., Competing Interests: Potential conflict of interest None declared., (Croatian Society of Medical Biochemistry and Laboratory Medicine.)

Objectives: To evaluate whether there is evidence of efficacy of the most commonly used medications in their primary indications., Study Design and Setting: This scoping review was executed using the Cochrane Library and MEDLINE databases up to May 2023. The 10 most prescribed medications in England, France, and the United States were identified using country-specific public databases. Up to 3 common indications in primary care were defined for each medication, based on a survey of general practitioners. The outcomes were determined by the authors to be patient-important outcomes, with placebo as the comparator. Two investigators independently conducted searches, following a predefined algorithm, to identify randomized controlled trials or meta-analyses of randomized controlled trials assessing the efficacy of these medications for each indication. The risk of bias was assessed using the ROBIS or ROB 2.0 tools., Results: We identified 21 drugs, covering 56 indications and 114 outcomes. Sixty-seven percent of the evaluated medications demonstrated efficacy for at least one outcome in at least one of the sought indications. Overall, evidence of efficacy was found for 48% of the indications. There was no study evaluating the efficacy of amoxicillin and salbutamol. For other drugs such as phloroglucinol or cholecalciferol, available studies suggested an absence of efficacy in the most common indications., Conclusion: This study underscores the lack of data regarding the level of evidence for the most prescribed medications. Limitations include the choice of outcomes, and the understanding that the absence of evidence is not synonymous with the absence of efficacy., Competing Interests: Declaration of competing interest All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/and declare: no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: In recent years intraocular lenses (IOLs) for correcting presbyopia have been significantly improved and diversified. There are currently many different IOL models based on a wide variety of optical designs., Objective: The wide variety of available IOL solutions to correct presbyopia can be challenging for surgeons and patients. In everyday practice, the question is which IOL is best for which patient., Material and Methods: This overview describes and categorizes the currently available implants. The respective optical properties are analyzed and clinical study results are discussed, in particular those evaluating visual performance and the occurrence of photic phenomena., Results: Monofocal-plus IOLs provide improved intermediate visual acuity with optimal distant visual acuity and minimal photic phenomena. Extended depth of field (EDoF) IOLs extend the depth of field through different optical principles and provide good distant and intermediate visual acuity. Trifocal lenses enable the greatest independence from spectacles at the price of a higher probability of dysphotopsia., Conclusion: The selection of the most suitable IOL for correction of presbyopia requires a balance between the patient's visual needs and possible side effects. An adequate knowledge of the currently available implants allows a patient-oriented selection of IOLs., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: The NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE) prospective observational study reported critical events requiring intervention during 35.2% of 6542 anesthetic episodes in 5609 infants up to 60 weeks postmenstrual age. The United Kingdom (UK) was one of 31 participating countries. Methods: Subgroup analysis of UK NECTARINE cases (12.8% of cohort) to identify perioperative critical events that triggered medical interventions. Secondary aims were to describe UK practice, identify factors more commonly associated with critical events, and compare 30‐day morbidity and mortality between participating UK and nonUK centers. Results: Seventeen UK centers recruited 722 patients (68.7% male, 36.1% born preterm, and 48.1% congenital anomalies) undergoing anesthesia for 876 surgical or diagnostic procedures at 25–60 weeks postmenstrual age. Repeat anesthesia/surgery was common: 17.6% patients prior to and 14.4% during the recruitment period. Perioperative critical events triggered interventions in 300/876 (34.3%) cases. Cardiovascular instability (16.9% of cases) and/or reduced oxygenation (11.4%) were more common in younger patients and those with co‐morbidities or requiring preoperative intensive support. A higher proportion of UK than nonUK cases were graded as ASA‐Physical Status scores >2 or requiring urgent or emergency procedures, and 39% required postoperative intensive care. Thirty‐day morbidity (complications in 17.2%) and mortality (8/715, 1.1%) did not differ from nonUK participants. Conclusions: Perioperative critical events and co‐morbidities are common in neonates and young infants. Thirty‐day morbidity and mortality data did not demonstrate national differences in outcome. Identifying factors associated with increased risk informs preoperative assessment, resource allocation, and discussions between clinicians and families. [ABSTRACT FROM AUTHOR]

Abstract Background Diagnostic accuracy studies aim to examine the diagnostic accuracy of a new experimental test, but do not address the actual merit of the resulting diagnostic information to a patient in clinical practice. In order to assess the impact of diagnostic information on subsequent treatment strategies regarding patient-relevant outcomes, randomized test-treatment studies were introduced. Various designs for randomized test-treatment studies, including an evaluation of biomarkers as part of randomized biomarker-guided treatment studies, are suggested in the literature, but the nomenclature is not consistent. Methods The aim was to provide a clear description of the different study designs within a pre-specified framework, considering their underlying assumptions, advantages as well as limitations and derivation of effect sizes required for sample size calculations. Furthermore, an outlook on adaptive designs within randomized test-treatment studies is given. Results The need to integrate adaptive design procedures in randomized test-treatment studies is apparent. The derivation of effect sizes induces that sample size calculation will always be based on rather vague assumptions resulting in over- or underpowered study results. Therefore, it might be advantageous to conduct a sample size re-estimation based on a nuisance parameter during the ongoing trial. Conclusions Due to their increased complexity, compared to common treatment trials, the implementation of randomized test-treatment studies poses practical challenges including a huge uncertainty regarding study parameters like the expected outcome in specific subgroups or disease prevalence which might affect the sample size calculation. Since research on adaptive designs within randomized test-treatment studies is limited so far, further research is recommended.

Background: Clinical characteristics, outpatient situation, and outcome in patients with psychogenic nonepileptic seizures (PNES) remain to be elucidated. Methods: Patients diagnosed with PNES after video‐electroencephalography (EEG) monitoring (VEM) 03/2000–01/2016 at the Erlangen Epilepsy Center were surveyed between June 2016 and February 2017. Primary outcome was PNES cessation defined as no PNES episodes within > = 12 months prior to the interview. Secondary outcome variables included quality of life (QoL) and dependency. Sensitivity analysis included patients with proven PNES during VEM without comorbid epilepsy. Results: Ninety‐nine patients were included (median age 38 (interquartile range (IQR 29–52)) years; 68 (69%) females, follow‐up 4 (IQR 2.1–7.7) years). Twenty‐eight (28%) patients suffered from comorbid epilepsy. Twenty‐five (25%) patients reported PNES cessation. Older age at symptom onset (odds ratio (OR) related to PNES cessation: 0.95 (95% CI 0.90–0.99)), comorbid epilepsy (OR 0.16 (95% CI 0.03–0.83)), anxiety disorder (OR 0.15 (95% CI 0.04–0.61)), and tongue biting (OR 0.22 (95% CI 0.03–0.91)) remained independently associated with ongoing PNES activity after adjustment. Sensitivity analysis (n = 63) revealed depressive disorder (OR 0.03 (95% CI 0.003–0.34)) instead of anxiety as independent predictor, while this seemed relevant only in patients older than 26 years at onset (OR 0.04 (95% CI 0.002–0.78) versus OR 0.21 (95% CI 0.02–1.84) in patients younger than 26 years). PNES cessation was associated with increased median QoL (8 (IQR 7–9) versus 5.5 (IQR 4–7); p <.001) and an increased frequency of financial independency (14 (56%) versus 21 (28%); p =.01). Conclusions: We found poor outcomes in PNES especially in older patients at onset with comorbid depressive disorder. Comorbid epilepsy also seems to be a major risk factor of ongoing PNES activity, which in turn affects patients' daily living. [ABSTRACT FROM AUTHOR]

Abstract Background Clinical characteristics, outpatient situation, and outcome in patients with psychogenic nonepileptic seizures (PNES) remain to be elucidated. Methods Patients diagnosed with PNES after video‐electroencephalography (EEG) monitoring (VEM) 03/2000–01/2016 at the Erlangen Epilepsy Center were surveyed between June 2016 and February 2017. Primary outcome was PNES cessation defined as no PNES episodes within > = 12 months prior to the interview. Secondary outcome variables included quality of life (QoL) and dependency. Sensitivity analysis included patients with proven PNES during VEM without comorbid epilepsy. Results Ninety‐nine patients were included (median age 38 (interquartile range (IQR 29–52)) years; 68 (69%) females, follow‐up 4 (IQR 2.1–7.7) years). Twenty‐eight (28%) patients suffered from comorbid epilepsy. Twenty‐five (25%) patients reported PNES cessation. Older age at symptom onset (odds ratio (OR) related to PNES cessation: 0.95 (95% CI 0.90–0.99)), comorbid epilepsy (OR 0.16 (95% CI 0.03–0.83)), anxiety disorder (OR 0.15 (95% CI 0.04–0.61)), and tongue biting (OR 0.22 (95% CI 0.03–0.91)) remained independently associated with ongoing PNES activity after adjustment. Sensitivity analysis (n = 63) revealed depressive disorder (OR 0.03 (95% CI 0.003–0.34)) instead of anxiety as independent predictor, while this seemed relevant only in patients older than 26 years at onset (OR 0.04 (95% CI 0.002–0.78) versus OR 0.21 (95% CI 0.02–1.84) in patients younger than 26 years). PNES cessation was associated with increased median QoL (8 (IQR 7–9) versus 5.5 (IQR 4–7); p

Background: To be able to make informed choices based on their individual preferences, patients need to be adequately informed about treatment options and their potential outcomes. This implies that studies measure the effects of care based on parameters that are relevant to patients. In a previous scoping review, we found a wide variety of supposedly patient-relevant parameters that equally addressed processes and outcomes of care. We were unable to identify a consistent understanding of patient relevance and therefore aimed to develop an empirically based concept including a generic set of patient-relevant parameters. As a first step we evaluated the process and outcome parameters identified in the scoping review from the patients' perspective.Methods: We conducted a cross-sectional survey among German general practice patients. Ten research practices of Witten/Herdecke University supported the study. During a two-week period in the fall of 2020, patients willing to participate self-administered a short questionnaire. It evaluated the relevance of the 32 parameters identified in the scoping review on a 5-point Likert scale and offered a free-text field for additional parameters. These free-text answers were inductively categorized by two researchers. Quantitative data were analyzed using descriptive statistics. Bivariate analyses were performed to determine whether there are any correlations between rating a parameter as highly relevant and patients' characteristics.Results: Data from 299 patients were eligible for analysis. All outcomes except 'sexuality' and 'frequency of healthcare service utilization' were rated important. 'Confidence in therapy' was rated most important, followed by 'prevention of comorbidity' and 'mobility'. Relevance ratings of five parameters were associated with patients' age and gender, but not with their chronic status. The free-text analysis revealed 15 additional parameters, 12 of which addressed processes of care, i.e., 'enough time in physician consultation'.Conclusion: Patients attach great value to parameters addressing processes of care. It appears as though the way in which patients experience the care process is not less relevant than what comes of it. Relevance ratings were not associated with chronic status, but few parameters were gender- and age-related.Trial Registration: Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1685. [ABSTRACT FROM AUTHOR]

Abstract Background With respect to patient-centered care, measuring care effects based on patient-relevant outcomes is becoming increasingly important. There is some uncertainty about what outcomes are particularly relevant to patients and who determines their relevance. To determine this, we conducted a scoping review of the international literature with the aim to improve the conceptual clarity regarding (1) the terminology used for supposedly patient-relevant outcomes, (2) the variety of outcomes considered patient-relevant, and (3) justifications for the choice of these specific outcomes. Methods We conducted a systematic search in Embase, PubMed (including Medline), Cochrane Central, Scopus, and Google Scholar with a special focus on article titles. Search terms included patient-relevant, patient-important, patient-preferred, and outcome(s), endpoint(s), parameter(s), indicator(s). We limited the search period from January 2000 to July 2019. Full-text articles reporting outcomes that were described as patient-relevant met the inclusion criteria. Two researchers independently analyzed all eligible articles applying quantitative and structuring content analysis. Results We identified 155 articles, 44 of which met the inclusion criteria. A content analysis revealed 35 different terms used with regard to patient-relevant outcomes. However, authors predominantly referred to patient-important outcomes (23 articles, 52.3%) and patient-relevant outcomes (17 articles, 38.6%). A structuring content analysis of all extracted outcomes revealed a total of 281 codes, pooled in 32 inductive categories. Among these, the following categories dominated: symptoms, adverse events/complications, survival/mortality, pain. In just 16 of the articles (36.4%), authors provided justifications for the choice of the outcome being based either on patient and/or expert opinions. In another 13 articles (29.5%), no justification was provided. Conclusion This scoping review on patient-relevant outcomes was driven by the questions (1) what outcomes are particularly relevant to patients, and (2) who determines their relevance. We found a wide range of supposedly patient-relevant outcomes, with only one third of articles involving patients in the justification of the outcome selection. In view of this conceptual uncertainty it appears difficult to determine or even to compare a particular patient benefit of interventions. A set of generic outcomes relevant to patients would be helpful to contribute to a consistent understanding of patient relevance.

Abstract Background The Hip disability and Osteoarthritis Outcome Score (HOOS) is a frequently used patient-reported outcome measure (PROM) for assessment of hip disorders and treatment effects following hip surgery. The objective of the study was to translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into Polish and to investigate the psychometric properties of the HOOS in patients with osteoarthritis undergoing total hip replacement (THR). Materials and methods The Polish version of the HOOS was developed according to current guidelines. Patients completed the HOOS, Short Form 36 Health Survey (SF-36), the visual analogue scale (VAS) for pain and the global perceived effect (GPE) scale. Psychometric properties including interpretability (floor/ceiling effects), internal consistency (Cronbach’s alpha), test-retest reliability (intra-class correlation coefficient, ICC), convergent construct validity (a priori hypothesized Spearman’s correlations between the HOOS subscales, the generic SF-36 measure and the VAS for pain) and responsiveness (effect size, association between the HOOS and GPE scores) were analyzed. Results The study included 157 patients (mean age 66.8 years, 54% women). Floor effects were found prior to THR for the HOOS subscales Sports and Recreation and Quality of Life. The Cronbach’s alpha was over 0.7 for all subscales indicating satisfactory internal consistency. The test–retest reliability was good for the HOOS subscale Pain (0.82) and excellent for all other subscales with ICCs ranging from 0.91 to 0.96. The minimal detectable change ranged from 12.0 to 26.2 on an individual level and from 1.4 to 3.0 on a group level. Seven out of eight a priori hypotheses were confirmed indicating good construct validity. Responsiveness was high since the expected pattern of effect sizes in all subscales was found. Conclusions The Polish version of the HOOS demonstrated good reliability, validity and responsiveness for use in patient groups having THR.

Background: Diagnostic accuracy studies aim to examine the diagnostic accuracy of a new experimental test, but do not address the actual merit of the resulting diagnostic information to a patient in clinical practice. In order to assess the impact of diagnostic information on subsequent treatment strategies regarding patient-relevant outcomes, randomized test-treatment studies were introduced. Various designs for randomized test-treatment studies, including an evaluation of biomarkers as part of randomized biomarker-guided treatment studies, are suggested in the literature, but the nomenclature is not consistent.Methods: The aim was to provide a clear description of the different study designs within a pre-specified framework, considering their underlying assumptions, advantages as well as limitations and derivation of effect sizes required for sample size calculations. Furthermore, an outlook on adaptive designs within randomized test-treatment studies is given.Results: The need to integrate adaptive design procedures in randomized test-treatment studies is apparent. The derivation of effect sizes induces that sample size calculation will always be based on rather vague assumptions resulting in over- or underpowered study results. Therefore, it might be advantageous to conduct a sample size re-estimation based on a nuisance parameter during the ongoing trial.Conclusions: Due to their increased complexity, compared to common treatment trials, the implementation of randomized test-treatment studies poses practical challenges including a huge uncertainty regarding study parameters like the expected outcome in specific subgroups or disease prevalence which might affect the sample size calculation. Since research on adaptive designs within randomized test-treatment studies is limited so far, further research is recommended. [ABSTRACT FROM AUTHOR]

Health technology assessment (HTA) of clinical and economic value of a new intervention is an integral step in providing the access of patients to innovative cancer care and treatment. Overall survival (OS) is the preferred criterion for demonstrating the therapeutic efficacy in HTA given its direct clinical and patient relevance. However, with often long life expectancy of patients with early cancer, analysis of OS becomes less practical. Partially due to this reason, pathological complete response (pCR) and time-to-event end-points like disease-free survival are frequently incorporated into the pivotal clinical trials in the neoadjuvant and adjuvant settings. However, there exists a discrepancy between different national HTA bodies regarding the acknowledgement of patient relevance of these end-points. In this article, we analysed the perspectives of patients on different aspects of end-points used in clinical trials in early cancer. Gathered evidence strongly suggests that complete tumour eradication and reduced risk of recurrence provide important psychological benefits thus signifying that pCR and time-to-event end-points are directly relevant to patients. Additionally, we reviewed opinions on patient relevance of neoadjuvant and adjuvant therapy end-points adopted by HTA bodies during the recent evaluations. We found that improvements in end-points used in the adjuvant setting were commonly considered as valuable to patients. In contrast, opinions on patient relevance of neoadjuvant therapy end-points varied between the national HTA bodies. Universal acknowledgement of patient relevance of therapeutic end-points for early cancer by HTA bodies is necessary to balance the inequality in uptake of innovative therapies into national healthcare systems. • Tumour eradication and reduced risk of recurrence are important to patients. • Time-to-event end-points are commonly accepted in health technology assessment (HTA). • Pathological complete response is often not considered as patient-relevant in HTA. • Adoption of (neo)adjuvant end-points in HTA improves access to innovative therapies. [ABSTRACT FROM AUTHOR]

Purpose: Pulmonary imaging finding of Coronavirus disease 2019 (COVID-19) has been widely described, but until now few studies have been published about abdominal radiological presentation. The aim of this study was to provide an overview of abdominal imaging findings in patients with COVID-19 in a multicenter study and correlate them with worse clinical outcomes. Materials and methods: This retrospective study included adult COVID-positive patients with abdominal CT performed from 4/1/2020 to 5/1/2020 from two institutions. Demographic, laboratory and clinical data were recorded, including clinical outcomes. Results: Of 81 COVID-positive patients, the average age was 61 years, 42 (52%) women and 45 (55%) had positive abdominopelvic findings. The most common abdominal imaging features were intestinal imaging findings (20/81, 24%), including colorectal (4/81, 5%) and small bowel thickening (10/81, 12%), intestinal distension (15/81, 18%), pneumatosis (1/81, 1%) and intestinal perforation (1/81, 1%). On multivariate analysis, intestinal imaging findings were associated with higher risk of worse outcome (death or invasive mechanical ventilation) (RR = 2.6, p = 0.04) and higher risk of invasive mechanical ventilation alone (RR = 6.2, p = 0.05). Conclusion: Intestinal abnormalities were common findings in COVID-19 patients who underwent abdominal CT and were significantly correlated to worse outcomes in the clinical follow-up.

Background: Along with conventional therapy, novel tools are being developed in balance training for the rehabilitation of persons with stroke sequelae. The efficacy of Computerized Balance Training thus far been the object of studies only in persons with chronic stroke. Objective: To investigate the effects of an early Computerized Balance Training on balance, walking endurance and independence in activities of daily living, in persons with mild hemiparesis in subacute phase. Methods: Thirty-two persons with a recent hemiparesis (within 4 weeks from stroke onset), able to maintain a standing position for at least 30 seconds, were randomly assigned to an experimental or control group. The control group (CG) were administered conventional physiotherapy of 40 minutes twice a day, 5 times a week for 4 weeks, while the experimental group (EG) underwent conventional physiotherapy 40 minutes once a day and Computerized Balance Training once a day, 5 times a week for 4 weeks. Outcomes were evaluated by means of Berg Balance Scale (BBS), Tinetti Balance Scale (TBS), Two Minutes Walk Test (2MWT), Barthel Index (BI) and stabilometric tests. Results: Twelve participants for each group completed the training. Each group experienced 8 dropouts. The mean age (years) was 58.1±20.4 for EG and 59.7±14,7 for CG; the days from stroke were respectively 27.9±15.5 and 20±11.7. The difference between the two groups was statistically significant in experimental group for BBS (p = 0.003), for TBS (p = 0.028), for Sensory Integration and Balance tests performed with closed eyes on steady (p = 0.009) or instable surface (p = 0.023). and for 2MWT (p = 0.008). Conclusions: Computerized Balance Training is an effective therapeutic tool for balance and gait endurance improvement in persons with stroke in subacute phase. [ABSTRACT FROM AUTHOR]

Objective: Population-wide mammographic screening programs aim to reduce breast cancer mortality. However, a broad view of the harms and benefits of these programs is necessary to favor informed decisions, especially in the earliest stages of the disease. Here, we compare the outcomes of patients diagnosed with breast ductal carcinoma in situ in participants and non-participants of a population-based mammographic screening program. Methods: A retrospective cohort study of all patients diagnosed with breast ductal carcinoma in situ between 2000 and 2010 within a single hospital. A total of 211 patients were included, and the median follow-up was 8.4 years. The effect of detection mode (screen-detected and non-screen-detected) on breast cancer recurrences, readmissions, and complications was evaluated through multivariate logistic regression analysis. Results: In the majority of women, breast ductal carcinoma in situ was screen-detected (63.5%). Screen-detected breast ductal carcinoma in situ was smaller in size compared to those non-screen-detected (57.53% < 20 mm versus 78.03%, p = 0.002). Overall, breast-conserving surgery was the most frequent surgery (86.26%); however, mastectomy was higher in non-screen-detected breast ductal carcinoma in situ (20.78% versus 9.7%, p = 0.024). Readmissions for mastectomy were more frequent in non-screen-detected breast ductal carcinoma in situ. Psychological complications, such as fatigue, anxiety, and depression, had a prevalence of 15% within our cohort. Risk of readmissions and complications was higher within the non-screen-detected group, as evidenced by an odds ratio = 6.25 (95% confidence interval = 1.95–19.99) for readmissions and an odds ratio = 2.41 (95% confidence interval = 1.95–4.86) for complications. Conclusions: Our findings indicate that women with breast ductal carcinoma in situ breast cancer diagnosed through population-based breast cancer screening program experience a lower risk of readmissions and complications than those diagnosed outside these programs. These findings can help aid women and health professionals make informed decisions regarding screening. [ABSTRACT FROM AUTHOR]

Background: With respect to patient-centered care, measuring care effects based on patient-relevant outcomes is becoming increasingly important. There is some uncertainty about what outcomes are particularly relevant to patients and who determines their relevance. To determine this, we conducted a scoping review of the international literature with the aim to improve the conceptual clarity regarding (1) the terminology used for supposedly patient-relevant outcomes, (2) the variety of outcomes considered patient-relevant, and (3) justifications for the choice of these specific outcomes.Methods: We conducted a systematic search in Embase, PubMed (including Medline), Cochrane Central, Scopus, and Google Scholar with a special focus on article titles. Search terms included patient-relevant, patient-important, patient-preferred, and outcome(s), endpoint(s), parameter(s), indicator(s). We limited the search period from January 2000 to July 2019. Full-text articles reporting outcomes that were described as patient-relevant met the inclusion criteria. Two researchers independently analyzed all eligible articles applying quantitative and structuring content analysis.Results: We identified 155 articles, 44 of which met the inclusion criteria. A content analysis revealed 35 different terms used with regard to patient-relevant outcomes. However, authors predominantly referred to patient-important outcomes (23 articles, 52.3%) and patient-relevant outcomes (17 articles, 38.6%). A structuring content analysis of all extracted outcomes revealed a total of 281 codes, pooled in 32 inductive categories. Among these, the following categories dominated: symptoms, adverse events/complications, survival/mortality, pain. In just 16 of the articles (36.4%), authors provided justifications for the choice of the outcome being based either on patient and/or expert opinions. In another 13 articles (29.5%), no justification was provided.Conclusion: This scoping review on patient-relevant outcomes was driven by the questions (1) what outcomes are particularly relevant to patients, and (2) who determines their relevance. We found a wide range of supposedly patient-relevant outcomes, with only one third of articles involving patients in the justification of the outcome selection. In view of this conceptual uncertainty it appears difficult to determine or even to compare a particular patient benefit of interventions. A set of generic outcomes relevant to patients would be helpful to contribute to a consistent understanding of patient relevance. [ABSTRACT FROM AUTHOR]

Background: The Hip disability and Osteoarthritis Outcome Score (HOOS) is a frequently used patient-reported outcome measure (PROM) for assessment of hip disorders and treatment effects following hip surgery. The objective of the study was to translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into Polish and to investigate the psychometric properties of the HOOS in patients with osteoarthritis undergoing total hip replacement (THR).Materials and Methods: The Polish version of the HOOS was developed according to current guidelines. Patients completed the HOOS, Short Form 36 Health Survey (SF-36), the visual analogue scale (VAS) for pain and the global perceived effect (GPE) scale. Psychometric properties including interpretability (floor/ceiling effects), internal consistency (Cronbach's alpha), test-retest reliability (intra-class correlation coefficient, ICC), convergent construct validity (a priori hypothesized Spearman's correlations between the HOOS subscales, the generic SF-36 measure and the VAS for pain) and responsiveness (effect size, association between the HOOS and GPE scores) were analyzed.Results: The study included 157 patients (mean age 66.8 years, 54% women). Floor effects were found prior to THR for the HOOS subscales Sports and Recreation and Quality of Life. The Cronbach's alpha was over 0.7 for all subscales indicating satisfactory internal consistency. The test-retest reliability was good for the HOOS subscale Pain (0.82) and excellent for all other subscales with ICCs ranging from 0.91 to 0.96. The minimal detectable change ranged from 12.0 to 26.2 on an individual level and from 1.4 to 3.0 on a group level. Seven out of eight a priori hypotheses were confirmed indicating good construct validity. Responsiveness was high since the expected pattern of effect sizes in all subscales was found.Conclusions: The Polish version of the HOOS demonstrated good reliability, validity and responsiveness for use in patient groups having THR. [ABSTRACT FROM AUTHOR]

Objectives: Variables collected early after severe traumatic brain injury (sTBI) could predict health-related quality of life (HRQoL). Our aim was to determine the prevalence of patients with a low HRQoL 4 years after sTBI and to develop a prediction model including early variables. Methods: Adult patients with both sTBI [abbreviated injury score of the head region (HAIS) >3] and disease-specific HRQoL assessments using the 'Quality of Life after Brain Injury' (QOLIBRI) were included. The outcome was the total score (TS) of QOLIBRI; cutoff for low HRQoL: <60 points. A multivariate logistic regression model and prediction model were performed. Results: One hundred-sixteen patients [median age 50.8 years (IQR 25.9–62.8; 21.6% >65 years)] were included; 68 (58.6%) with HAIS = 4, 48 (41.4%) with HAIS = 5. Median Glasgow Coma Scale (GCS) was 13 (IQR 3–15). Median TS was 77 (IQR 60–88). Low HRQoL was observed in 28 patients (24.1%). Two variables were associated with low HRQoL: GCS <13, working situation other than employed or retired. The prediction model had an AUROC of 0.765; calibration was moderate (Hosmer Lemeshow Chi2 6.82, p =.556). Conclusion: One in four patients had a low HRQoL after 4 years. A lower GCS and working situations were associated with low HRQoL. [ABSTRACT FROM AUTHOR]

Background: Researchers are currently discussing the need for consensus on a core set of outcome measures to assess interventions in aphasia. For indirect, environmental approaches to aphasia intervention, such as communication partner training (CPT), the roadmap to obtaining consensus on core outcome measures seems especially complex. While the purpose of CPT is to improve communication for people with communication disorders, the intervention is aimed at the communication partner. There is also a variety of goals, activities, and possible settings for CPT. This complexity increases the risk of a mismatch between the goals and content of the intervention and measures used to evaluate the outcome. Aims: The purpose of this paper is to describe the complexity of measuring outcomes from CPT. The aim is to enable clinicians and researchers to reflect on the outcomes to be measured and also on how different types of measures may or may not be aligned with the goals and content of a specific CPT intervention. Main contribution: The current proliferation of outcome measures used in CPT is considered in the light of a survey of general factors to be considered in evaluating intervention outcomes. The complexity of measuring outcomes in CPT is illustrated and the importance of alignment of main objectives, intervention tasks, and projected outcomes is exemplified by referencing two common types of CPT approaches. Objectives relating to knowledge of aphasia, interactional behaviour, and feelings and attitudes are considered in relation to specific outcome measurements. It is suggested that both study-specific and more general measures are needed for capturing and comparing outcomes. The measurement of relevant outcome in CPT is discussed along with implications for future research and clinical practice. Conclusions: Different CPT approaches share the same purpose of facilitating communication in aphasia, but their application in research studies or in the clinic, is specific to the particular context. Special care must thus be taken in both clinical practice and research to safeguard the alignment between objectives, tasks, and projected intervention outcomes and the actual measures used. Further, it is concluded that there is a need for the development of new measures based on a consensus on key outcomes to be measured in CPT. [ABSTRACT FROM AUTHOR]

Purpose:To identify important treatment outcomes from the perspective of people with aphasia and their families using the ICF as a frame of reference. Methods:The nominal group technique was used with people with aphasia and their family members in seven countries to identify and rank important treatment outcomes from aphasia rehabilitation. People with aphasia identified outcomes for themselves; and family members identified outcomes for themselves and for the person with aphasia. Outcomes were analysed using qualitative content analysis and ICF linking. Results:A total of 39 people with aphasia and 29 family members participated in one of 16 nominal groups. Inductive qualitative content analysis revealed the following six themes: (1) Improved communication; (2) Increased life participation; (3) Changed attitudes through increased awareness and education about aphasia; (4) Recovered normality; (5) Improved physical and emotional well-being; and (6) Improved health (and support) services. Prioritized outcomes for both participant groups linked to all ICF components; primary activity/participation (39%) and body functions (36%) for people with aphasia, and activity/participation (49%) and environmental factors (28%) for family members. Outcomes prioritized by family members relating to the person with aphasia, primarily linked to body functions (60%). Conclusions:People with aphasia and their families identified treatment outcomes which span all components of the ICF. This has implications for research outcome measurement and clinical service provision which currently focuses on the measurement of body function outcomes. The wide range of desired outcomes generated by both people with aphasia and their family members, highlights the importance of collaborative goal setting within a family-centred approach to rehabilitation. These results will be combined with other stakeholder perspectives to establish a core outcome set for aphasia treatment research.Implications for RehabilitationImportant outcomes for people with aphasia and their families span all components of the ICF.The relevancy and translation of research findings may be increased by measuring and reporting research outcomes which are important to people living with aphasia.The results of this study indicate that important treatment outcomes for people living with aphasia most frequently link to the activity/participation and body function components of the ICF.The outcomes identified in this study suggest a broad role for clinicians working in aphasia rehabilitation. The categories of identified outcomes may be used clinically as a starting point in goal-setting discussions with clients and their families. [ABSTRACT FROM PUBLISHER]

Hintergrund: Optimale Ergebnisse wie geringere Morbidität, höhere Patienten- und Mitarbeiterzufriedenheit sowie niedrigere Versorgungskosten im heutigen diagnosefokussierten Gesundheitssystem können durch eine effektive interprofessionelle Zusammenarbeit erreicht werden. Ziel: Basierend auf der Literatur und eigenen klinischen Erfahrungen wird erfolgreiche beziehungsweise verbesserungswürdige interprofessionelle Zusammenarbeit reflektiert. Ergebnisse: Einige Faktoren unterstützen den interprofessionellen Ansatz: das Ausräumen von Vorurteilen gegenüber anderen Berufsgruppen schon in der Grundausbildung - kollektives Lernen, um späteres gemeinsames Arbeiten zu fördern; frühzeitige Förderung der Wertschätzung der Kompetenzen der jeweils anderen Berufsgruppe durch Kommunikation; Organisationsstrukturen nach erforderlicher Fachkompetenz, ohne dass eine Berufsgruppe der anderen vorgesetzt ist; konstruktives Hinterfragen der Handlungsweisen oder Therapieentscheide; Schaffen von Anreizen im Gesundheitssystem zur Stimulation von gemeinsamem Lernen und Arbeiten. Schlussfolgerungen: Von Bereichen wie Intensiv- und Notfallmedizin aber auch der palliativen Versorgung, in denen die Interprofessionalität schon heute gelebt wird, kann gelernt werden, wie eine positive Beeinflussung alltäglicher Prozesse im Sinn der Interprofessionalität möglich wird. Dies stellt einen Paradigmenwechsel im beruflichen Selbstverständnis dar, der in einzelnen Bereichen bereits teilweise vollzogen wird. Neben dem Fachpersonal sollte zukünftig auch der Patient - u nd möglicherweise seine Angehörigen - als weiteres Teammitglied gesehen werden, wodurch eine personenzentrierte Versorgung gewährleistet wird. Effekte einer solchen Teamarbeit müssen bezogen auf gemeinsam definierte Ergebnisse evaluiert werden, um zukunftsweisende Modelle der interprofessionellen Zusammenarbeit zu entwickeln und fördern. Background: Optimal outcomes such as lower mortality, greater satisfaction of patients and health care professionals, and lower health care costs within the current diagnosis oriented health care system, can be achieved by effective interprofessional collaboration. Aim: The aim of this review article is to describe the structure as well as the characteristics of the psychometric qualities of the DOS scale. Aim: Based on the literature and our own clinical experiences, we reflect on successful or improvable interprofessional collaboration. Results: Some factors supporting this development are: to dispel preconceptions towards other professions as early as basic education and to support collective learning so as to enhance later collaborative work; early assistanc e to appreciate the competences of other professions by communication; organizing structures according to the necessary professional competenceswithout having the superior authority of one profession over the other; constructive challenging of procedures or therapeutic decisions; promotion of incentives within the health care system for the stimulation of collective learning and working. Conclusion: We can learn how it is possible to have a positive influence on everyday pr ocesses from areas such as intensive care, emergency care, but also palliative care, where interprofessionalism is already a reality. This will mean a change in paradigm of the professional self-concept, which has already been partially implemented in some areas. In the future, patients and possibly family members could also be seen as team members, alongside the professionals, to ensure person-centered care. The effects of such teamwork have to be evaluated with regard to mutually defined outcomes to develop and facilitate forward-looking models of interprofessional collaboration. [ABSTRACT FROM AUTHOR]

Introduction: All national orthopaedic societies advocate the use of patient reported outcome measures (PROMs), but clear guidance on their use is limited. We utilised a collaborative methodology to perform a national audit aiming to assess the perceived variability in PROMs practice in orthopaedic surgery in the United Kingdom., Methods: A multicentre collaborative audit of practice was performed extracting PROMs data on 21 commonly performed orthopaedic procedures. For each procedure, data were collected for frequency of PROM collection, type of PROM chosen, administration intervals, method and reason for collection. Compliance with national society recommendations was undertaken., Results: Sixty-three trusts enrolled to participate in the study with a completion rate of 60% (38 trusts). The most frequently reported PROMs were those associated with best practice tariffs (83.3% and 80.6% for hip and knee replacements, respectively). Outside incentivised programmes we observed a higher rate of variation in PROMs practice which failed to meet our audit standard. Across all procedures evaluated, 69% (221/318) of respondents to the study used paper as the primary method of PROM collection., Conclusions: This is the first national audit of PROMs collection in orthopaedics. The integration of PROMs within best practice tariff platforms positively influences the frequency and standardisation of collection. Outside this initiative, PROMS collection is infrequent and highly varied despite the presence of several registries. Because PROMs collection is a recommendation across all procedures using implantable devices, the success of this will depend on the adequacy of funding, resource delivery and the presence of clearer recommendations.

Patient centeredness as the focus of healthcare delivery requires the incorporation of patient-reported outcomes into clinical trials. Clearly defining measurable outcomes as well as selecting the most appropriate validated collection tool to use is imperative for success. Creating and validating one’s own instrument is also possible, albeit more cumbersome. Meticulous data collection to avoid missing data is key, as is limiting the number of data collection points to prevent survey fatigue and using electronic systems to facilitate data gathering and analysis. Working in a multidisciplinary team that includes statisticians with expertise in patient reported outcomes is essential to navigate the complexities of statistical analysis of these variables. Use of available and emerging technologies for data collection and analysis as well as data sharing will greatly facilitate the process of incorporating patient-reported outcomes into trials and routine clinical practice. [ABSTRACT FROM AUTHOR]

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Electronic health record content is created by clinicians and is driven largely by intermittent and brief encounters with patients. Collecting data directly from patients in the form of patient-generated data (PGD) provides an unprecedented opportunity to capture personal, contextual patient information that can supplement clinical data and enhance patients' self-care. The US Department of Veterans Affairs (VA) is striving to implement the enterprise-wide capability to collect and use PGD in order to partner with patients in their care, improve the patient healthcare experience, and promote shared decision making. Through knowledge gained from Veterans' and healthcare teams' perspectives, VA created a taxonomy and an evolving framework on which to design and develop applications that capture and help physicians utilize PGD. Ten recommendations for effectively collecting and integrating PGD into patient care are discussed, addressing health system culture, data value, architecture, policy, data standards, clinical workflow, data visualization, and analytics and population reach. [ABSTRACT FROM AUTHOR]

When the efficacy of a new medical drug is compared against that of an established competitor in a randomized controlled trial, the difference in patient-relevant outcomes, such as mortality, is usually measured directly. In diagnostic research, however, the impact of diagnostic procedures is of an indirect nature as test results do influence downstream clinical decisions, but test performance (as characterized by sensitivity, specificity, and the predictive values of a procedure) is, at best, only a surrogate endpoint for patient outcome and does not necessarily translate into it. Not many randomized controlled trials have been conducted so far in diagnostic research, and, hence, we need alternative approaches to close the gap between test characteristics and patient outcomes. Several informal approaches have been suggested in order to close this gap, and decision modeling has been advocated as a means of obtaining formal approaches. Recently, the expected benefit has been proposed as a quantity that allows a simple formal approach, and we take up this suggestion in this paper. We regard the expected benefit as an estimation problem and consider two approaches to statistical inference. Moreover, using data from a previously published study, we illustrate the possible insights to be gained from the application of formal inference techniques to determine the expected benefit. [ABSTRACT FROM AUTHOR]

The aim of this research was to develop a quantitative method for clinicians to predict the probability of improved prognosis in patients with coronavirus disease 2019 (COVID-19). Data on 104 patients admitted to hospital with laboratory-confirmed COVID-19 infection from 10 January 2020 to 26 February 2020 were collected. Clinical information and laboratory findings were collected and compared between the outcomes of improved patients and non-improved patients. The least absolute shrinkage and selection operator (LASSO) logistics regression model and two-way stepwise strategy in the multivariate logistics regression model were used to select prognostic factors for predicting clinical outcomes in COVID-19 patients. The concordance index (C-index) was used to assess the discrimination of the model, and internal validation was performed through bootstrap resampling. A novel predictive nomogram was constructed by incorporating these features. Of the 104 patients included in the study (median age 55 years), 75 (72.1%) had improved short-term outcomes, while 29 (27.9%) showed no signs of improvement. There were numerous differences in clinical characteristics and laboratory findings between patients with improved outcomes and patients without improved outcomes. After a multi-step screening process, prognostic factors were selected and incorporated into the nomogram construction, including immunoglobulin A (IgA), C-reactive protein (CRP), creatine kinase (CK), acute physiology and chronic health evaluation II (APACHE II), and interaction between CK and APACHE II. The C-index of our model was 0.962 (95% confidence interval (CI), 0.931-0.993) and still reached a high value of 0.948 through bootstrapping validation. A predictive nomogram we further established showed close performance compared with the ideal model on the calibration plot and was clinically practical according to the decision curve and clinical impact curve. The nomogram we constructed is useful for clinicians to predict improved clinical outcome probability for each COVID-19 patient, which may facilitate personalized counselling and treatment., (© 2020 THE AUTHORS.)

Abstract Background Epidemiological studies have, so far, identified factors associated with increased risk for incident or progressive OA, such as age, sex, heredity, obesity, and joint injury. There is, however, a paucity of long-term data that provide information on the nature of disease progression on either group or individual levels. Such information is needed for identification of study cohorts and planning of clinical trials. The aim of the study was, thus, to assess the variation in pain and function on group and individual level over 2 years in previously meniscectomized individuals with and without radiographic knee osteoarthritis (OA). Methods 143 individuals (16% women, mean age at first assessment 50 years [range 27–83]) were assessed twice; approximately 14 and 16 years after isolated meniscectomy, with a median interval of 2.3 years (range 2.3–3.0). Radiographic OA (as assessed at the time of second evaluation) was present in the operated knee in 40%, and an additional 19% had a single osteophyte grade 1 in one or both of the tibiofemoral compartments. Subjects completed the self-administered and disease-specific Knee injury and Osteoarthritis Outcome Score (KOOS). Results There were no significant changes in the group mean KOOS subscale scores over the 2-year period. However, a great variability over time was seen within individual subjects. Out of 143 subjects, 16% improved and 12% deteriorated in the subscale Pain, and 13% improved and 14% deteriorated in the subscale ADL ≥ 10 points (the suggested threshold for minimal perceptible clinical change). Similar results were seen for remaining subscales. Conclusion Group mean scores for this study cohort enriched in incipient and early-stage knee OA were similar over 2 years, but pain, function and quality of life changed considerably in individuals. These results may be valid also for other at risk groups with knee OA, and motivate further careful examination of the natural history of OA, as well as properties of the OA outcome instruments used. Longitudinal outcome data in OA studies need to be analyzed both on an individual and a group level.

Computer-assisted surgery represents a relatively novel treatment option in total hip arthroplasty, which has been supported by the technological progress over the latest decades. Navigation and robotics enable increasing the precision of cup positioning, as well as successful biomechanical restoration of leg length and offset. However, the intended target area is still one of debate in literature. Besides the learning curve, the use of navigation and robotics requires additional time and financial expense, which has not yet been addressed in the German healthcare system. This is one reason why computer-assisted surgery has not fully attained everyday routine. The number of comparative studies is limited, but the results are promising. However, if these surrogate measures will end in reduced revision rates or better outcome is unclear. Further prospective studies and register analysis might illuminate the potential benefit of navigation and robotics.

Purpose: Pulmonary imaging finding of Coronavirus disease 2019 (COVID-19) has been widely described, but until now few studies have been published about abdominal radiological presentation. The aim of this study was to provide an overview of abdominal imaging findings in patients with COVID-19 in a multicenter study and correlate them with worse clinical outcomes., Materials and Methods: This retrospective study included adult COVID-positive patients with abdominal CT performed from 4/1/2020 to 5/1/2020 from two institutions. Demographic, laboratory and clinical data were recorded, including clinical outcomes., Results: Of 81 COVID-positive patients, the average age was 61 years, 42 (52%) women and 45 (55%) had positive abdominopelvic findings. The most common abdominal imaging features were intestinal imaging findings (20/81, 24%), including colorectal (4/81, 5%) and small bowel thickening (10/81, 12%), intestinal distension (15/81, 18%), pneumatosis (1/81, 1%) and intestinal perforation (1/81, 1%). On multivariate analysis, intestinal imaging findings were associated with higher risk of worse outcome (death or invasive mechanical ventilation) (RR = 2.6, p = 0.04) and higher risk of invasive mechanical ventilation alone (RR = 6.2, p = 0.05)., Conclusion: Intestinal abnormalities were common findings in COVID-19 patients who underwent abdominal CT and were significantly correlated to worse outcomes in the clinical follow-up., Competing Interests: The authors declare that they have no conflict of interest., (© 2021 The Authors.)