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A valid and reliable nursing assessment is essential for identifying required care and ensuring patient safety. The convenience of conducting a comprehensive assessment of the patient has led to a significant increase in assessment tools that may slow down the process. Nevertheless, the possibility of consolidating various instruments that measure common or similar constructs into a meta-instrument is considered an alternative that could enhance assessment efficiency. A meta-instrument can be defined as a measurement tool that consolidates other instruments based on measuring related constructs and sharing dimensions or items, aiming to achieve a more parsimonious measurement. Literature on such assessment tools is scarce, and there are numerous options for their construction and initial validation. Additionally, it is advisable to confirm their psychometric properties and ensure that they maintain, at the very least, the same diagnostic capacity as the original instruments. This article presents a proposal for the phases to follow in constructing meta-instruments, along with various methodological alternatives that can be employed based on the characteristics of the original instruments and the purpose of creating the meta-instrument. Furthermore, special attention is given to the checklists that should be used to study the psychometric properties and diagnostic capacity of the meta-instruments. Finally, future lines of research and challenges in the development of nursing assessment meta-instruments are discussed.

Objective: The Temperament Evaluation of Memphis, Pisa, Paris, and San Diego - Auto-questionnaire (TEMPS-A) assesses five affective temperaments and has been translated into 32 languages. A 35-item short version is available in Persian, but the complete version is not yet translated. This study aimed to assess the validity and reliability of the complete Persian version of the TEMPS-A in an Iranian population. Method : This descriptive study translated the TEMPS-A questionnaire from English to Persian using a standard forward-backward method. The translation was evaluated for face and content validity by 10 psychiatry specialists, with quantitative content validity assessed through content validity ratio (CVR) and content validity index (CVI) calculations. The Persian TEMPS-A was completed twice, with a two-week interval, by 30 individuals out of the 319 medical staff of Imam Hossein Hospital in Tehran, Iran, who participated in the study, and its reliability was evaluated using Cronbach\'s alpha. The questionnaire was then distributed to the entire sample (n = 319) for the analysis of temperament frequencies and statistical indices by a statistician. Results: The Persian version of the TEMPS-A, consisting of 110 items across five factors (depressive, cyclothymic, hyperthymic, irritable, and anxious), demonstrated excellent reliability with Cronbach\'s alpha values of 0.910, 0.909, 0.911, 0.910, and 0.909, respectively. The questions related to cyclothymic and hyperthymic temperaments exhibited the highest and lowest correlation coefficients with the general scale, respectively. Most subscales in the Persian TEMPS-A version showed correlation coefficients ranging from 0.28 to 0.68. An ANOVA with Cochrane\'s test revealed a significant difference in the mean scores of the questionnaire items (P < 0.001), with a grand mean score of 1.73 across all questions. Conclusion: The Persian version of the TEMPS-A, consisting of 110 items, showed good internal consistency and a strong correlation with the original version. This suggests that it is suitable for use in temperament studies among the Iranian population.

OBJECTIVE: To establish the construct validity of the Spanish version of the BARRIERS scale.
METHODS: Methodological study of validation of a measurement instrument based on data from previously published studies. The study population consisted of nurses from the Basque Health Service and the Canary Health Service. The following variables were extracted and unified: Years of professional experience, possession of a specialist nursing degree, possession of a doctorate, type of activity performed by the professional and field of work. For construct validation, a confirmatory factor analysis (CFA) was performed based on the initial model proposed for the scale and RASCH analysis. A polychoric correlation matrix, factor extraction by unweighted least squares and PROMIN oblique rotation were used. For the RASCH analysis, the Joint Maximun Likelihood estimation (JMLE) method was used; the fit of the items and persons were estimated by means of outfit - Unweighted Mean Square fit statistic (UMS) and infit -Weighted Mean Square Fit Statistic (WMS), as well as the reliability and separation of items and persons.
RESULTS: A total of 1200 nurses and midwives made up the final validation sample (n = 1200), with a mean professional experience of 21.22 ± 9.26 years. The CFA presented a good fit to the data (KMO = 0.935 [95% CI: 0.921-0.945]), changing the factorial assignment in 6 items, while 5 items received factorial scores in more than one factor. The fit values for the 4-factor solution were RMSEA = 0.026 [95% CI: 0.026-0.027] and GFI = 0.991 [95% CI: 0.986-0.991]. In the RASCH analysis most items presented infit-WMS and outfit-UMS values with a good fit.
CONCLUSIONS: The Spanish version of the BARRIERS scale has adequate construct validity although there are changes in the assignment of items to the dimensions compared to the original model. The RASCH analysis indicates adequate fit for both persons and items.

BACKGROUND: Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission\'s In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures.
OBJECTIVE: This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory.
METHODS: It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory.
BACKGROUND: The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given.
CONCLUSIONS: With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.

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UNASSIGNED: Implantation of a left ventricular assist device (LVAD) is a crucial therapeutic option for selected end-stage heart failure patients. However, major bleeding (MB) complications postimplantation are a significant concern.
UNASSIGNED: We evaluated current risk scores\' predictive accuracy for MB in LVAD recipients.
UNASSIGNED: We conducted an observational, single-center study of LVAD recipients (HeartWare or HeartMate-3, November 2010-December 2022) in the Netherlands. The primary outcome was the first post-LVAD MB (according to the International Society on Thrombosis and Haemostasis [ISTH] and Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and INTERMACS combined with intracranial bleeding [INTERMACS+] criteria). Mortality prior to MB was considered a competing event. Discrimination (C-statistic) and calibration were evaluated for the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly score, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke score, Anticoagulation and Risk Factors in Atrial Fibrillation score, Outpatient Bleeding Risk Index, venous thromboembolism score, atrial fibrillation score, and Utah Bleeding Risk Score (UBRS).
UNASSIGNED: One hundred four patients were included (median age, 64 years; female, 20.2%; HeartWare, 90.4%; HeartMate-3, 9.6%). The cumulative MB incidence was 75.7% (95% CI 65.5%-85.9%) by ISTH and INTERMACS+ criteria and 67.0% (95% CI 56.0%-78.0%) per INTERMACS criteria over a median event-free follow-up time of 1916 days (range, 59-4521). All scores had poor discriminative ability on their intended prediction timeframe. Cumulative area under the receiving operator characteristic curve ranged from 0.49 (95% CI 0.35-0.63, venous thromboembolism-BLEED) to 0.56 (95% CI 0.47-0.65, UBRS) according to ISTH and INTERMACS+ criteria and from 0.48 (95% CI 0.40-0.56, Anticoagulation and Risk Factors in Atrial Fibrillation) to 0.56 (95% CI 0.47-0.65, UBRS) per INTERMACS criteria. All models showed poor calibration, largely underestimating MB risk.
UNASSIGNED: Current bleeding risk scores exhibit inadequate predictive accuracy for LVAD recipients. There is a need for an accurate risk score to identify LVAD patients at high risk of MB who may benefit from patient-tailored antithrombotic therapy.

OBJECTIVE: This article summarizes the current level of validation for several nociception monitors using a categorized validation process to facilitate the comparison of performance.
RESULTS: Nociception monitors improve the detection of a shift in the nociception and antinociception balance during anesthesia, guiding perioperative analgesic therapy. A clear overview and comparison of the validation process for these monitors is missing.
RESULTS: Within a 2-year time-frame, we identified validation studies for four monitors [analgesia nociception index (ANI), nociception level monitor (NOL), surgical pleth index (SPI), and pupillometry]. We categorized these studies in one out of six mandatory validation steps: developmental studies, clinical validation studies, pharmacological validation studies, clinical utility studies, outcome improvement studies and economical evaluation studies. The current level of validation for most monitors is mainly focused on the first three categories, whereas ANI, NOL, and SPI advanced most in the availability of clinical utility studies and provide confirmation of a clinical outcome improvement. Analysis of economical value for public health effects is not yet publicly available for the studied monitors.
CONCLUSIONS: This review proposes a stepwise structure for validation of new monitoring technology, which facilitates comparison between the level of validation of different devices and identifies the need for future research questions.

BACKGROUND: Acupuncture is widely used worldwide; however, studies on its effectiveness have been impeded by limitations regarding the design of appropriate control groups. In clinical research, noninvasive sham acupuncture techniques can only be applied through validation studies. Therefore, this systematic review aimed to evaluate the scope of existing literature on this topic to identify trends.
METHODS: We queried Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials databases from inception to July 2022 for relevant articles. Author names were used to identify additional relevant articles. Two independent reviewers assessed the identified articles based on the inclusion and exclusion criteria. The following data were extracted: study design, information regarding acupuncturists and participants, general and treatment-related characteristics of the intervention and control groups, participants\' experience of acupuncture, and research findings.
RESULTS: The database query yielded 673 articles, of which 29 articles were included in the final review. Among these, 18 involved the use of one of three devices: Streitberger (n = 5), Park (n = 7), and Takakura (n = 6) devices. The remaining 11 studies used other devices, including self-developed needles. All the included studies were randomized controlled trials. The methodological details of the included studies were heterogeneous with respect to outcomes assessed, blinding, and results.
CONCLUSIONS: Sham acupuncture validation studies have been conducted using healthy volunteers, with a focus on blind review and technological developments in sham acupuncture devices. However, theren may be language bias in our findings since we could not query Chinese and Japanese databases due to language barriers. There is a need for more efforts toward establishing control groups suitable for various acupuncture therapy interventions. Moreover, there is a need for more rigorous sham acupuncture validation studies, which could lead to higher-quality clinical studies.

BACKGROUND: Federal legislation still prohibits the cultivation, sale, and consumption of cultivars of delta 9-tetrahydrocannabinol cannabis (>0.3%); however, as of November 2022, 39 states have legalized cannabis and cannabis derived products for medicinal consumption and 21 states have legalized for adult-use consumption. This state-by-state approach has produced a patch work of regulations that multi-state operators (MSOs) must learn to navigate. Furthermore, cannabis laboratories often lack the space and skill needed to perform method validations, adding another layer of complexity. While these barriers exist, it is paramount for MSOs to demonstrate the fitness of purpose of their methods.
OBJECTIVE: This review presents the complexity that an MSO navigated in developing microbiology method validation study designs for two proprietary real-time PCR (RT-PCR) assays to meet four state (California, Florida, Michigan, and Oklahoma) testing requirements. The testing in each state was conducted in addition to certification of the assays through the AOAC Performance Tested MethodSM (PTM) program.
METHODS: Matrix studies were conducted targeting three analytes (Aspergillus spp., Salmonella spp., and Shiga toxin-producing Escherichia coli) as directed by the state regulatory authorities. For California, inclusivity and exclusivity studies were performed. The number of contamination levels, test portion replicates, and total target organisms evaluated varied by state. Culture confirmation was not performed outside of the AOAC PTM studies.
RESULTS: Data from each study was collected, summarized, and provided to the state regulatory agencies. Review of the data consisted of identifying discrepant results and verification of controls. After review, each assay was certified for use in the respective state.
CONCLUSIONS: Requirements from each of the states demonstrate the complexities MSOs face and emphasize the need for a more standardized approach to streamline acceptance of alternative methods.
CONCLUSIONS: While varying state regulations can be complex, validation studies performed for the candidate methods have led to adoption across 31 states.