Integrating theories of proactive motivation, team innovation climate, and motivation in teams, we developed and tested a multilevel model of motivators of innovative performance in teams. Analyses ...of multisource data from 428 members of 95 research and development (R&D) teams across 33 Chinese firms indicated that team-level support for innovation climate captured motivational mechanisms that mediated between transformational leadership and team innovative performance, whereas members' motivational states (role-breadth self-efficacy and intrinsic motivation) mediated between proactive personality and individual innovative performance. Furthermore, individual motivational states and team support for innovation climate uniquely promoted individual innovative performance, and, in turn, individual innovative performance linked team support for innovation climate to team innovative performance.
Pathogen detection and identification are key elements in outbreak control of human, animal, and plant diseases. Since many fungal plant pathogens cause similar symptoms, are difficult to distinguish ...morphologically, and grow slowly in culture, culture-independent, sequence-based diagnostic methods are desirable. Whole genome metagenomic sequencing has emerged as a promising technique because it can potentially detect any pathogen without culturing and without the need for pathogen-specific probes. However, efficient DNA extraction protocols, computational tools, and sequence databases are required. Here we applied metagenomic sequencing with the Oxford Nanopore Technologies MinION to the detection of the fungus Calonectria pseudonaviculata, the causal agent of boxwood (Buxus spp.) blight disease. Two DNA extraction protocols, several DNA purification kits, and various computational tools were tested. All DNA extraction methods and purification kits provided sufficient quantity and quality of DNA. Several bioinformatics tools for taxonomic identification were found suitable to assign sequencing reads to the pathogen with an extremely low false positive rate. Over 9% of total reads were identified as C. pseudonaviculata in a severely diseased sample and identification at strain-level resolution was approached as the number of sequencing reads was increased. We discuss how metagenomic sequencing could be implemented in routine plant disease diagnostics.
In evaluating the clinical benefit of new therapeutic interventions, it is critical that the treatment outcomes assessed reflect aspects of health that are clinically important and meaningful to ...patients. Performance outcome (PerfO) assessments are measurements based on standardized tasks actively undertaken by a patient that reflect physical, cognitive, sensory, and other functional skills that bring meaning to people’s lives. PerfO assessments can have substantial value as drug development tools when the concepts of interest being measured best suit task performance and in cases where patients may be limited in their capacity for self-report. In their development, selection, and modification, including the evaluation and documentation of validity, reliability, usability, and interpretability, the good practice recommendations established for other clinical outcome assessment types should continue to be followed, with concept elicitation as a critical foundation. In addition, the importance of standardization, and the need to ensure feasibility and safety, as well as their utility in patient groups, such as pediatric populations, or those with cognitive and psychiatric challenges, may enhance the need for structured pilot evaluations, additional cognitive interviewing, and evaluation of quantitative data, such as that which would support concept confirmation or provide ecological evidence and other forms of construct evidence within a unitary approach to validity. The opportunity for PerfO assessments to inform key areas of clinical benefit is substantial and establishing good practices in their selection or development, validation, and implementation, as well as how they reflect meaningful aspects of health is critical to ensuring high standards and in furthering patient-focused drug development.
•Performance outcome (PerfO) assessments are most useful when the concept of interest for measurement is best measured via ability to perform standardized tasks. For instance, PerfO assessments may be important when patients are limited in their capacity for self-report and when heterogeneity could affect the utility of self-report of activities in day-to-day life. Although there are PerfO assessment-specific considerations, most of the good practice recommendations established for other Clinical Outcome Assessments types remain directly applicable.•In contrast to patient-reported outcome measures that are direct assessments of the identified meaningful aspects of health, PerfO assessments incorporate the performance of representative standardized tasks that indirectly assess the meaningful aspect of health. Thus, evidence supporting the relationship between the tasks selected to assess the concept of interest and the meaningful aspect of health it is intended to represent/reflect must be generated or assembled.•With PerfO assessments, a significant amount of attention must be placed on the feasibility of the selected task performance in the specific context of use (eg, target patient population) along with the physical environment in which it will be conducted. Because of the relatively greater complexity around standardization of instructions, materials, setting, patient safety, and administrator and patient training, recommendations are provided regarding the critical role of a pilot evaluation.
We developed a NitroPure Nitrocellulose (NPN) membrane-based method for sampling and storing grapevine sap for grapevine virus detection. We devised an efficient nucleic acid extraction method for ...the NPN membrane, resulting in 100% amplification success for grapevine leafroll-associated virus 2 (GLRaV2) and 3 (GLRaV3), grapevine rupestris stem pitting-associated virus (GRSPaV), grapevine virus A, grapevine virus B, and grapevine red blotch virus (GRBV). This method also allowed the storage of recoverable nucleic acid for 18 months at room temperature. We created a sampling kit to survey GLRaV2, GLRaV3, and GRBV in Japanese vineyards. We tested the kits in the field in 2018 and then conducted mail-in surveys in 2020–2021. The results showed a substantial prevalence of GLRaV3, with 48.5% of 132 sampled vines being positive. On the other hand, only 3% of samples tested positive for GLRaV2 and none for GRBV.
Objectives
To assess the measurement properties of the Migraine‐Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) electronic patient‐reported outcome (ePRO) Role Function‐Restrictive (RFR) ...domain to evaluate the functional impact of migraine in patients with episodic (EM) or chronic migraine (CM) enrolled in clinical trials.
Methods
The 7‐item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG n = 851 and CGAH n = 909) and 1 CM (CGAI n = 1090) Phase 3 galcanezumab clinical trials. Anchor‐ and distribution‐based analyses were utilized to derive a responder threshold for clinical interpretation of change over time. The Migraine Disability Assessment (MIDAS), Patient Global Impression of Severity (PGI‐S), Patient Global Impression of Improvement (PGI‐I), and migraine headache days (MHD) served as anchors. Responsiveness and responder threshold analyses were completed from baseline to the average of months 4‐6 for EM studies, and from baseline to month 3 for the CM study; timeframes selected were based on the primary endpoints in these studies.
Results
Cronbach’s alpha values for internal consistency reliability were 0.93, 0.92, and 0.92, for CGAG, CGAH, and CGAI, respectively. Test–retest reliability intra‐class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients. Convergent validity was supported by moderate to strong correlations (≥0.30) between the RFR and both MIDAS and PGI‐S. Known‐groups validity was established between subgroups stratified by baseline PGI‐S and MHD (P < .05; δ = 0.35‐1.96). For the EM studies, anchor variables suggested a change of ≥25 points (equivalent to 9 points/state changes on raw scale) in the RFR was an appropriate threshold to interpret a treatment benefit. For the CM study a change of ≥17.14 points (6 points/state changes on raw scale) was an appropriate threshold. In all 3 studies, significantly (P < .01) more galcanezumab patients achieved the responder definition thresholds, as compared to placebo (odds ratios of 1.98, 2.45, 2.27, 2.44, 1.64, and 1.66 for the 120 and 240 mg arms in the CGAG, CGAH, and CGAI trials, respectively).
Conclusion
The MSQv2.1 ePRO RFR has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in EM and CM clinical trials to assess the functional impact of migraine.
Contemporary studies of chemical contamination in Antarctica commonly focus on remnants of historical local releases or long-range transport of legacy pollutants. To protect the continent’s pristine ...status, the Antarctic Treaty’s Protocol on Environmental Protection prohibits importation of persistent organic pollutants. However, some polybrominated diphenyl ether (PBDE) congeners exhibit similar properties. Many modern polymer-containing products, e.g., home/office furnishings and electronics, contain percent levels of flame retardant PBDEs. PBDE concentrations in indoor dust and wastewater sludge from the U.S. McMurdo and New Zealand-operated Scott Antarctic research bases were high. Levels tracked those in sludge and dust from their respective host countries. BDE-209, the major constituent in the commercial deca-PBDE product, was the dominant congener in sludge and dust, as well as aquatic sediments collected near the McMurdo wastewater outfall. The pattern and level of BDE-209 sediment concentrations, in conjunction with its limited environmental mobility, suggest inputs from local sources. PBDE concentrations in fish and invertebrates near the McMurdo outfall rivaled those in urbanized areas of North America and generally decreased with distance. The data indicate that reliance on wastewater maceration alone, as stipulated by the Protocol, may permit entry of substantial amounts of PBDEs and other chemicals to the Antarctic environment.
OBJECTIVE
To explore the risk factors and comorbid conditions associated with subgroups of lower urinary tract symptoms (LUTS) in men and women aged ≥40 years in three countries, using data from the ...EpiLUTS study, as LUTS are common amongst men and women and increase in prevalence with age.
SUBJECTS AND METHODS
This cross‐sectional, population‐representative survey was conducted via the Internet in the USA, the UK and Sweden. Participants were asked to rate how often they experienced individual LUTS during the past 4 weeks on a 5‐point Likert scale. Eight LUTS subgroups were created. Descriptive statistics and logistic regressions within each LUTS subgroup were used to assess the data.
RESULTS
The survey response rate was 59%. The final sample was 30 000 (men and women). The voiding + storage + postmicturition (VSPM) group reported the highest rates of comorbid conditions for both men and women, and the fewest were reported in the no/minimal LUTS and the postmicturition‐only groups. Increasing age was associated with increasing LUTS in men, but not in women. Comorbid conditions significantly associated with the VSPM group were arthritis, asthma, chronic anxiety, depression, diabetes (men only), heart disease, irritable bowel syndrome, neurological conditions, recurrent urinary tract infection, and sleep disorders. Risk factors, such as body mass index, exercise level and smoking, played less of a role, except for childhood nocturnal enuresis, which was significantly associated with most LUTS subgroups.
CONCLUSION
In this large population study, many comorbid conditions and risk factors were significantly associated with LUTS among both men and women. Further longitudinal investigations of the associations noted here would help physicians to understand the pathophysiology of LUTS and comorbid conditions, and provide clinical guidelines for patient management of comorbid conditions sharing common pathophysiological pathways.
Abstract
Objectives
There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge.
...Methods
Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States.
Results
Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop
validity arguments
akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims.
Conclusions
A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The Female Sexual Function Index (FSFI) has consistently been shown to have discriminant validity, test–retest reliability, and internal consistency as a measure of female sexual function. However, ...the content validity (relevance, clarity, comprehensiveness) of the instrument in women with hypoactive sexual desire disorder (HSDD) must also be established.
The aim of this study were to assess the content validity of the FSFI, specifically the FSFI desire domain, in pre‐ and postmenopausal women with HSDD.
Two single‐visit content validation studies were conducted in the United States. Eligible premenopausal (both studies) and postmenopausal (second study only) women with HSDD completed the FSFI followed by one‐on‐one, face‐to‐face cognitive debriefing interviews including open‐ended questions to capture information on their perceptions of the instrument. Information on women's experiences of decreased sexual desire was also captured.
The main outcome measures of this study were the women's ratings of the clarity, ease of understanding, comprehensiveness, and relevance of the 19 items of the FSFI.
Interviews with 15 premenopausal women (first study), and 30 pre‐ and 31 postmenopausal women (second study), were analyzed. Across the whole sample, most women (80–100%) found every item of the FSFI clear and easy to understand. The majority (53–70%) felt that the FSFI captured all their feelings about decreased sexual desire and other sexual problems, and most (84–90%) indicated that additional questions were unnecessary. Most women in both studies (93–100%) reported that the two items comprising the FSFI desire domain were clear, easy to understand, and were relevant to them. The majority of women thought that a recall period of ≥7 days is most relevant for recall of their sexual desire.
These studies establish the content validity of the FSFI in pre‐ and postmenopausal women with HSDD, supporting the use of this instrument as a measure of sexual function in women with this condition. Revicki DA, Margolis MK, Bush EN, DeRogatis LR, and Hanes V. Content validity of the female sexual function index (fsfi) in pre‐ and postmenopausal women with hypoactive sexual desire disorder (HSDD). J Sex Med 2011;8:2237–2245.
Antibacterial woven polyester fabrics are drawing much attention in the medical and textile industries because they can provide many health-promoting properties that prevent infection while providing ...a barrier to the external environment. In this work, we developed and investigated two different polyester fabrics to demonstrate the antibacterial, non-adhesive, and moisture wicking properties of a multicomponent wound dressing. Vertical wicking of a braided layer composed of Poly-l-lactide (PLLA) yarn of 4-deep-grooved (4DG) fibers was tested using porcine blood serum to mimic wound exudate viscosity. Bacterial inhibition of Pseudomonas putida was measured after exposure to gentamicin sulfate (GS)-incorporated PLLA skin-contact layers of two different shaped yarns. Poly-ethylene glycol (PEG) was added to the GS PLLA contact layer to further prevent non-specific cellular attachment. Results indicated vertical wicking of moisture at 0.88 mm/s. While a specific wicking rate for adequate wound moisture regulation has not been indicated in the literature due to wound and patient variability, we assert that rapid removal of excess fluid from the wound bed, as demonstrated by our fabric is an essential component for a comprehensive wound dressing. Antibacterial experiments showed that GS exhibited both bactericidal and bacteriostatic trends by killing bacteria and further inhibiting growth, respectively. The surface treatment of PEG on PLLA contact layers showed less cellular attachment, promoting non-adhesion during dressing changes. Ultimately, using woven polyester medical textiles in wound care allows for optimizing parameters, such as antimicrobial uptake/release and moisture wicking for personalized healing. The construct studied here may serve as a tunable platform for development of wound dressings with specific antibacterial, moisture, and tissue adhesion requirements.
PDF
