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The Creighton Competency Evaluation Instrument (CCEI) was modified from an existing instrument, the Creighton Simulation Evaluation Instrument, for use in the National Council of States Boards of Nursing National Simulation Study (NCSBN NSS). The CCEI was developed for the NCSBN NSS for use as the evaluation instrument for both simulation and traditional clinical experiences in associate and baccalaureate nursing programs. Five nursing programs assisted with reliability and validity testing of the CCEI. Using a standardized validation questionnaire, faculty rated the CCEI on its ability to accurately measure student performance and clinical competency. Videos scripted at three levels of performance were used to test reliability. Content validity ranged from 3.78 to 3.89 on a four-point Likert-like scale. Cronbach's alpha was > .90 when used to score three different levels of simulation performance. The CCEI is useful for evaluating both the simulation and traditional clinical environments.

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and.

Background Patient and public engagement is growing, but evaluative efforts remain limited. Reviews looking at evaluation tools for patient engagement in individual decision making do exist, but no similar articles in research and health systems have been published. Objective Systematically review and appraise evaluation tools for patient and public engagement in research and health system decision making. Methods We searched literature published between January 1980 and February 2016. Electronic databases (Ovid MEDLINE, Embase, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO) were consulted, as well as grey literature obtained through Google, subject‐matter experts, social media and engagement organization websites. Two independent reviewers appraised the evaluation tools based on 4 assessment criteria: scientific rigour, patient and public perspective, comprehensiveness and usability. Results In total, 10 663 unique references were identified, 27 were included. Most of these tools were developed in the last decade and were designed to support improvement of engagement activities. Only 11% of tools were explicitly based on a literature review, and just 7% were tested for reliability. Patients and members of the public were involved in designing 56% of the tools, mainly in the piloting stage, and 18.5% of tools were designed to report evaluation results to patients and the public. Conclusion A growing number of evaluation tools are available to support patient and public engagement in research and health system decision making. However, the scientific rigour with which such evaluation tools are developed could be improved, as well as the level of patient and public engagement in their design and reporting.

Purpose The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), 14 positively worded statements, is a validated instrument to measure mental wellbeing on a population level. Less is known about the population distribution of the shorter seven-item version (SWEMWBS) or its performance as an instrument to measure wellbeing. Methods Using the Health Survey for England 2010—2013 (n = 27,169 adults aged 16+, nationally representative of the population), age- and sex-specific norms were estimated using means and percentiles. Criterion validity was examined using: (1) Spearman correlations (ρ) for SWEMWBS with General Health Questionnaire (GHQ-12), happiness index, EQ-VAS (2) a multinomial logit model with SWEMWBS (low, medium and high wellbeing) as the outcome and demographic, social and health behaviours as explanatory variables. Relative validity was examined by comparing SWEMWBS with WEMWBS using: (1) Spearman correlations (continuous data), and (2) the weighted kappa statistic (categorical), within population subgroups. Results Mean (median) SWEMWBS was 23.7 (23.2) for men and 23.2 (23.2) for women (p = 0.100). Spearman correlations were moderately sized for the happiness index (ρ = 0.53, P < 0.001), GHQ-12 (ρ = —0.52, p < 0.001) and EQ-VAS (ρ = 0.40, p < 0.001). Participants consuming <1 portion of fruit and vegetables a day versus ≥5 (odds ratio = 1.43 95% Confidence Interval = (1.22—1.66)) and current smokers versus non-smokers (1.28 (1.15—1.41)) were more likely to have low vs medium wellbeing. Participants who binge drank versus non-drinkers were less likely to have high versus medium wellbeing (0.81 (0.71—0.92)). Spearman correlations between SWEMWBS and WEMWBS were above 0.95; weighted kappa statistics showed almost perfect agreement (0.79—0.85). Conclusion SWEMWBS distinguishes mental wellbeing between subgroups, similarly to WEMWBS, but is less sensitive to gender differences.

Objective To shorten the Patient Engagement In Research Scale (PEIRS) to its most essential items and evaluate its measurement properties for assessing the degree of patients’ and family caregivers’ meaningful engagement as partners in research projects. Methods A prospective cross‐sectional web‐based survey in Canada and the USA, and also paper‐based in Canada. Participants were patients or family caregivers who had engaged in research projects within the last 3 years, were ≥17 years old, and communicated in English. Extensive psychometric analyses were conducted. Results 119 participants: 99 from Canada, 74 female, 51 aged 17‐35 years and 50 aged 36‐65 years, 60 had post‐secondary education, and 74 were Caucasian/white. The original 37‐item PEIRS was shortened to 22 items (PEIRS‐22), mainly because of low inter‐item correlations. PEIRS‐22 had a single dominant construct that accounted for 55% of explained variance. Analysis of PEIRS‐22 scores revealed the following: (1) acceptable floor and ceiling effects (<15%), (2) internal consistency (ordinal alpha = 0.96), (3) structural validity by fit to a Rasch measurement model, (4) construct validity by moderate correlations with the Public and Patient Engagement Evaluation Tool, (5) good test‐retest reliability (ICC2,1 = 0.86) and (6) interpretability demonstrated by significant differences among PEIRS‐22 scores across three levels of global meaningful engagement in research. Conclusions The shortened PEIRS is valid and reliable for assessing the degree of meaningful patient and family caregiver engagement in research. It enables standardized assessment of engagement in research across various contexts. Patient or public contribution A researcher‐initiated collaboration, patient partners contributed from study conception to manuscript write‐up.

Background As citizens, patients and family members are participating in numerous and expanding roles in health system organizations, attention has turned to evaluating these efforts. The context‐specific nature of engagement requires evaluation tools to be carefully designed for optimal use. We sought to address this need by assessing the appropriateness and feasibility of a generic tool across a range of health system organizations, engagement activities and patient groups. Methods We used a mixed‐methods implementation research design to study the implementation of an engagement evaluation tool in seven health system organizations in Ontario, Canada focusing on two key implementation outcome variables: appropriateness and feasibility. Data were collected through respondent feedback questions (binary and open‐ended) at the end of the tool's three questionnaires as well as interviews and debriefing discussions with engagement professionals and patient partners from collaborating organizations. Results The three questionnaires comprising the evaluation tool were collectively administered 29 times to 405 respondents yielding a 52% response rate (90% and 53% of respondents respectively assessed the survey's appropriateness and feasibility [quantitatively or qualitatively]). The questionnaires' basic properties were rated highly by all respondents. Concrete suggestions were provided for improving the appropriateness and feasibility of the questionnaires (or components within) for different engagement activity and organization types, and for enhancing the timing of implementation. Discussion and Conclusions Our study findings offer guidance for health system organizations and evaluators to support the optimal use of engagement evaluation tools across a variety of health system settings, engagement activities and respondent groups.

This research identifies six online course evaluation instruments used nationally or in statewide systems. We examined the characteristics (i.e., number of standards and criteria) and coded the criteria that guide the design of online courses. We discussed the focus of the instruments and their unique features.

The Timed-Up and Go (TUG) test is widely utilized by healthcare professionals for assessing fall risk and mobility due to its practicality. Currently, test results are based solely on execution time, but integrating technological devices into the test can provide additional information to enhance result accuracy. This study aimed to assess the reliability of smartphone-based instrumented TUG (iTUG) parameters. We conducted evaluations of intra- and inter-device reliabilities, hypothesizing that iTUG parameters would be replicable across all experiments. A total of 30 individuals participated in Experiment A to assess intra-device reliability, while Experiment B involved 15 individuals to evaluate inter-device reliability. The smartphone was securely attached to participants’ bodies at the lumbar spine level between the L3 and L5 vertebrae. In Experiment A, subjects performed the TUG test three times using the same device, with a 5 min interval between each trial. Experiment B required participants to perform three trials using different devices, with the same time interval between trials. Comparing stopwatch and smartphone measurements in Experiment A, no significant differences in test duration were found between the two devices. A perfect correlation and Bland–Altman analysis indicated good agreement between devices. Intra-device reliability analysis in Experiment A revealed significant reliability in nine out of eleven variables, with four variables showing excellent reliability and five showing moderate to high reliability. In Experiment B, inter-device reliability was observed among different smartphone devices, with nine out of eleven variables demonstrating significant reliability. Notable differences were found in angular velocity peak at the first and second turns between specific devices, emphasizing the importance of considering device variations in inertial measurements. Hence, smartphone inertial sensors present a valid, applicable, and feasible alternative for TUG assessment.

To demonstrate how the 22-item Patient Engagement in Research Scale (PEIRS-22) can be used to develop recommendations for improving the meaningfulness of patient engagement. PEIRS-22 previously captured quantitative evaluation data from 15 patient partners in a self-study of the Strategy for Patient-Oriented Research (SPOR) Evidence Alliance. Guided by deliberative dialogue, the current study involved 3 steps: (1) In-depth analysis and interpretation of the PEIRS-22 data produced a lay evidence summary with identified areas for improvement of meaningful engagement; (2) A 3-hour virtual workshop with patient partners and researchers generated initial recommendations; and (3) In two successive post-workshop surveys, ratings by workshop invitees led to consensus on the recommendations. Twenty-five participants attended the workshops and dialogued on 8 areas for improvement identified from the PEIRS-22 data. Twenty-eight unique initial recommendations led to consensus on 14 key recommendations organized across 4 categories: setting expectations for all team members, building trust and ongoing communication, providing opportunities to enhance learning and to develop skills, and acknowledging contributions of patient partners. Using PEIRS-22 data within a deliberate dialogue elucidated 14 actionable recommendations to support ongoing improvement of patient engagement at SPOR Evidence Alliance, a pan-Canadian health research initiative.

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.