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The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers' regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem.

Objective: To assess differences between traditional paper bag ordering and online ordering from primary school canteens in terms of menu, usage and lunch order characteristics.Design: A cross-sectional study.Setting: New South Wales (NSW) primary schools that offered both paper bag and online canteen ordering.Participants: Students (aged 5-12 years) with a lunch order on the day of the observation.Results: Across the six school canteens, 59-90 % of all available items were listed on both the online and paper menus, with no significant differences in the nutritional quality ('Everyday'/'Occasional') or nutritional content (kJ/saturated fat/sugar/sodium) of menu items. In total, 387 student lunch orders were placed, containing 776 menu items. Most orders (68 %) were placed online. There were no significant differences between order modality in the quantity of items ordered or the cost of orders, or the nutritional quality of orders based on the classification system of the NSW Healthy School Canteen Strategy ('Everyday'/'Occasional'). However, nutritional analysis revealed that paper bag orders contained 222 fewer kJ than online orders (P = 0·001), 0·65 g less saturated fat (P = 0·04) and 4·7 g less sugar (P < 0·001).Conclusions: Online canteens are commonly used to order canteen lunches for primary school children. This is the first study to investigate differences between traditional paper bag ordering and online ordering in this setting. Given the rapid increase in the use of online ordering systems in schools and other food settings and their potential to deliver public health nutrition interventions, additional research is warranted to further investigate differences in ordering modalities. [ABSTRACT FROM AUTHOR]

With the push for evidence-informed policy and practice, schools and policy makers are now increasingly encouraged and supported to use and enagage with research evidence. This means that consumers of research will now need to be discerning in judging the quality of research evidence that will inform their decisions. This paper evaluates the quality of evidence behind some well-known education programmes using examples from previous reviews of over 5,000 studies on a range of topics. It shows that much of the evidence is weak, and fundamental flaws in research are not uncommon. This is a serious problem if teaching practices and important policy decisions are made based on such flawed evidence. Lives may be damaged and opportunities missed. The aim of this paper is to show how widespread this problem is and to suggest ways by which the quality of education research may be improved. For example, funders of research and research bodies need to insist on quality research and fund only those that meet the minimum quality criteria. Journal editors and reviewers need to be cognizant of fundamental flaws in research and reject such submissions. One way to do this is to encourage submission of the research design and research protocol prior to acceptance, so acceptance or rejection is based on the design and not on the outcomes. This helps prevent publication bias and biased reporting. Individual researchers can improve quality by making it their moral responsibility to be truthful and transparent.

Many practitioner researchers strive to understand which assessment practices have the best impact on learning, but in authentic educational settings, it can be difficult to determine whether one intervention, for example the introduction of an online quiz to a course studied by diverse students, is responsible for the observed effect. This paper uses examples to highlight some of the difficulties inherent in assessment research and suggests some ways to overcome them. Problems observed in the literature include: assuming that if two effects are correlated then one must have caused the other; confounding variables obscuring the true relationships; experimental approaches that are too far removed from reality; and the danger that self-reported behaviour and opinion is sometimes different from student's actual behaviour. Practical solutions include: the use of an experimental or pseudo-experimental approach; the use of mixed methods; and the use of meta-analysis.

Background: Previous research has found that a "web-push" approach to data collection, which involves contacting people by mail to request an Internet survey response while withholding a paper response option until later in the contact process, consistently achieves lower response rates than a "paper-only" approach, whereby all respondents are contacted and requested to respond by mail.Method: An experiment was designed, as part of the Millennium Cohort Family Study, to compare response rates, sample representativeness, and cost between a web-push and a paper-only approach; each approach comprised 3 stages of mail contacts. The invited sample (n = 4,935) consisted of spouses married to U.S. Service members, who had been serving in the military between 2 and 5 years as of October, 2011.Results: The web-push methodology produced a significantly higher response rate, 32.8% compared to 27.8%. Each of the 3 stages of postal contact significantly contributed to response for both treatments with 87.1% of the web-push responses received over the Internet. The per-respondent cost of the paper-only treatment was almost 40% higher than the web-push treatment group. Analyses revealed no meaningfully significant differences between treatment groups in representation.Conclusion: These results provide evidence that a web-push methodology is more effective and less expensive than a paper-only approach among young military spouses, perhaps due to their heavy reliance on the internet, and we suggest that this approach may be more effective with the general population as they become more uniformly internet savvy. [ABSTRACT FROM AUTHOR]

Background: When a journal receives a duplicate publication, the ability to identify the submitted work as previously published, and reject it, is an assay to publication ethics best practices. The aim of this study was to evaluate how three different types of journals, namely open access (OA) journals, subscription-based journals, and presumed predatory journals, responded to receiving a previously published manuscript for review.Methods: We performed a quasi-experimental study in which we submitted a previously published article to a random sample of 602 biomedical journals, roughly 200 journals from each journal type sampled: OA journals, subscription-based journals, and presumed predatory journals. Three hundred and three journals received a Word version in manuscript format, while 299 journals received the formatted publisher's PDF version of the published article. We then recorded responses to the submission received after approximately 1 month. Responses were reviewed, extracted, and coded in duplicate. Our primary outcome was the rate of rejection of the two types of submitted articles (PDF vs Word) within our three journal types.Results: We received correspondence back from 308 (51.1%) journals within our study timeline (32 days); (N = 46 predatory journals, N = 127 OA journals, N = 135 subscription-based journals). Of the journals that responded, 153 received the Word version of the paper, while 155 received the PDF version. Four journals (1.3%) accepted our paper, 291 (94.5%) journals rejected the paper, and 13 (4.2%) requested a revision. A chi-square test looking at journal type, and submission type, was significant (χ2 (4) = 23.50, p < 0.001). All four responses to accept our article came from presumed predatory journals, 3 of which received the Word format and 1 that received the PDF format. Less than half of journals that rejected our submissions did so because they identified ethical issues such as plagiarism with the manuscript (133 (45.7%)).Conclusion: Few journals accepted our submitted paper. However, our findings suggest that all three types of journals may not have adequate safeguards in place to recognize and act on plagiarism or duplicate submissions. [ABSTRACT FROM AUTHOR]

Purpose: This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use.Methods: Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated.Results: The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys.Conclusions: A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy. [ABSTRACT FROM AUTHOR]

Background: The essence of humanism in medicine and health care is relationships-caring relationships between clinicians and patients. While raising concerns regarding professional-patient boundaries has positively contributed to our understanding and prevention of potentially harmful boundary violations, there is controversy about which types of relationships, caring acts, and practices are acceptable versus cross boundary lines.Objective: To examine primary care physicians' practices and attitudes regarding acts that have been questioned as potentially "inappropriate" or "unethical" crossing of professional-patient boundaries.Design: Surveys conducted via in-person polling or electronic and mailed paper submissions from April 2016 to July 2017. We calculated descriptive statistics and examined associations with practices and attitudes using logistic regression.Participants: Random sample of all US primary care physicians who treat adult patients; convenience sample of attendees at medicine grand rounds presentations.Main Measures: Outcomes were self-reported practices and attitudes related to giving patients rides home, paying for patients' medication, helping patients find jobs, employing patients, going to dinner with patients, and providing care to personal friends.Key Results: Among 1563 total respondents, 34% had given a ride home, 34% had paid for medications, 15% helped patients find a job, 7% had employed a patient, 10% had dinner with patients, and 59% provided care to personal friends. A majority disapproved of dinner with a patient (75%) but approved of or were neutral on all other scenarios (61-90%).Conclusions: The medical profession is quite divided on questions related to drawing lines about appropriate boundaries. Contrary to official and widespread proscriptions against such practices (with exception of dinner dates), many have actually engaged in such practices and the majority found them acceptable. [ABSTRACT FROM AUTHOR]

Purpose: In the higher education sector, the evaluation of learning and teaching projects is assuming a role as a quality and accountability indicator. The purpose of this paper is to investigate how learning and teaching project evaluation is approached and critiques alignment between evaluation theory and practice. Design/Methodology/Approach: The emergent realism paradigm provides the theoretical framework with a pragmatic approach to mixed-methods data collection. Thematic analysis was used to analyze the transcripts of interviews with 15 project leaders. Findings: Four key themes on project evaluation emerged: how evaluation is conceptualized, particularly the overlap, even conflation, between evaluation and research; capability building within the sector; resourcing in terms of time and money; and the role of an action-oriented approach to evaluation. The authors conclude that misalignment exists between evaluation theory and the practice of project evaluation and that this relationship can be further inhibited by a project leader's perception of evaluation. Practical Implications: A series of strategies for developing capacity across the higher education sector for project evaluation are presented. These include the development and provision of: a time allocation for evaluation in future and ongoing project plans with procedures to revisit the project and assess impact; models of how to incorporate evaluation into the research cycle; constructive feedback on evaluation reports from the university funding body; and networking opportunities to disseminate learnings from project evaluations. Originality/Value: This study focusses on the under-researched area of evaluation of learning and teaching projects in higher education, providing research-based evidence for strategies to develop sector capacity.

Evaluation research conducted in agencies that sanction law violators is often challenging and due process may preclude evaluators from using experimental methods in traditional criminal justice agencies such as police, courts, and corrections. However, administrative agencies often deal with the same population but are not bound by due process rules. This paper examines three randomized controlled trials conducted in an administrative agency and outlines the benefits of working in a nontraditional criminal justice agency over traditional criminal justice settings. Also addressed are barriers encountered and methods for overcoming set-backs. The findings demonstrate that the challenges of conducting randomized controlled trials in administrative agencies are similar to those experienced in police agencies, courts, and corrections. However, administrative contexts also have advantages over traditional criminal justice agencies and criminal justice researchers and scholars should broaden their focus and examine administrative agencies as feasible environments for conducting rigorous research on offending populations.

Background/objectives: The growing interest of medical community about sarcopenia resulted in the production of several clinical practice guidelines (CPGs), with an unavoidable variability in terms of the overall quality of those publications. Our aim is to evaluate the quality of CPGs on sarcopenia using the AGREE II instrument.Subjects/methods: We performed an online literature search for sarcopenia CPGs using different databases. Four independent reviewers evaluated the quality of CPGs using the AGREE II instrument. To classify the quality of each guideline, we defined specific thresholds of final score: high-quality if five or more domains scored >60%; average-quality if three or four domains scored >60%; low-quality if ≤2 domains scored >60%.Results: Our literature search yielded 315 articles, and after applying exclusion criteria our final analysis included 19 CPGs. The overall quality of CPGs was remarkable, as 13/19 (68.4%) were considered of "high-quality" CPGs, with more than four domains reached a score higher than 60%. "Scope and Purpose" and "Clarity of Presentations" had the best domain results (78.4% and 73.8%, respectively), while the two domains with the lowest scores were "Rigor of Development" and "Applicability" (61.5% and 58.7%, respectively). Interobserver variability ranged between moderate (0.624) and fair (0.275).Conclusions: Our study showed that the overall quality of CPGs about sarcopenia was noteworthy, as more than two-third of paper obtained a "high-quality" score. The domain "applicability" had the lowest score, suggesting that emphasis should be put on possible strategies for helping other doctors to implement guideline recommendations in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study is to comparatively evaluate the anti-inflammatory and antiapoptotic effects of bone marrow and adipose-derived mesenchymal stem cells (MSCs) applied subconjunctivally after alkaline corneal burn. Methods: Thirty-two rats were divided into 4 groups and included in the study (n = 8). While no intervention was made in the control group, a chemical burn was created by applying 4 μL of NaOH soaked in 6 mm filter paper to the right eye of each subject in the other groups under general anesthesia. While only subconjunctival 0.1 mL phosphate-buffered saline (PBS) was injected to in the group 1, 2 × 106 adipose or bone marrow-derived MSC in 0.1 mL PBS was applied subconjunctivally to the subjects in the remaining groups (Group 2 and 3, respectively). Tissue samples were collected for histological analysis on the third day after the burn. Tissue samples were evaluated light microscopically and immunohistochemically stained for interleukin-1 beta (IL-1β), tumor necrosis factor alpha (TNF-α), caspase-3 (Cas-3), and CD68. Results: The IL-1β and TNF-α staining scores and the number of CD68- and Cas-3-positive stained cells were significantly lower in the groups given bone marrow and adipose-derived MSC compared to the alkaline burn group (P < 0.0001, for all parameters). Epithelial IL-1β and TNF-α staining scores were significantly lower in the bone marrow-derived MSC group compared to the adipose-derived MSC group (P < 0.0001, for all parameters). Conclusions: The presented study shows that both bone-marrow and adipose-derived MSCs support wound healing in the corneal tissue and strongly suppress the inflammation occured in the tissue. [ABSTRACT FROM AUTHOR]

Background: Patients with disabilities often require healthcare accommodations in order to access high-quality, equitable healthcare services. While attention has been paid to accommodation needs in specific disability populations, limited research to date has explored healthcare accommodations that cross-cut diverse disability populations.Objective: To identify a deeper understanding regarding accommodations in healthcare settings that could apply across disability populations and promote equitable healthcare.Design: We conducted qualitative focus groups with patients with disabilities and caregivers to understand their experiences and preferences for healthcare accommodations.Participants: We recruited patients and caregivers across all major disability categories to participate in focus groups. Participants were recruited through advocacy organizations and healthcare settings in Southeastern Minnesota.Approach: A total of eight focus groups were conducted with 56 participants. Participants described their healthcare experiences and desires for healthcare accommodations. The multidisciplinary research team recorded, transcribed verbatim, and coded all focus groups. The team thematically coded transcripts using content analysis within and across focus groups to identify major themes.Key Results: Patients identified four challenges and corresponding steps healthcare team could take to promote equitable care: (1) consistent documentation of disabilities and needed accommodations in the medical record; (2) allowance for accommodations to the environment, including adapting physical space, physical structures, and scheduling and rooming processes; (3) provide accommodations for administrative tasks, such as completing paper or electronic forms; and (4) adapt communication during interactions, such as speaking slower or using terms that patients can easily understand.Conclusion: These identified themes represent specific opportunities for healthcare teams to effectively provide accessible care to patients with disabilities. Many of the accommodations require minimal financial investment, but did require behavioral changes by the healthcare team to ensure equitable healthcare. [ABSTRACT FROM AUTHOR]

Background Context: Smartphone-based applications enable new prospects to monitor symptoms and assess functional outcome in patients with lumbar degenerative spinal disorders. However, little is known regarding patient acceptance and preference towards new modes of digital objective outcome assessment.Purpose: To assess patient preference of an objective smartphone-based outcome measure compared to conventional paper-based subjective methods of outcome assessment.Study Design: Prospective observational cohort study.Patient Sample: Fourty-nine consecutive patients undergoing surgery for lumbar degenerative spinal disorder.Outcome Measures: Patients completed a preference survey to assess different methods of outcome assessment. A 5-level Likert scale ranged from strong disagreement (2 points) over neutral (6 points) to strong agreement (10 points) was used.Methods: Patients self-determined their objective functional impairment using the 6-minute Walking Test application (6WT-app) and completed a set of paper-based patient-reported outcome measures (PROMs) before and 6 weeks after surgery. Patients were then asked to rate the methods of outcome assessment in terms of suitability, convenience, and responsiveness to their symptoms.Results: The majority of patients considered the 6WT-app a suitable instrument (median 8.0, interquartile range [IQR] 4.0). Patients found the 6WT more convenient (median 10.0, IQR 2.0) than the Zurich Claudication Questionnaire (ZCQ; median 8.0, IQR 4.0, p=.019) and Core Outcome Measure Index (COMI; median 8.0, IQR 4.0, p=.007). There was good agreement that the 6WT-app detects change in physical performance (8.0, IQR 4.0). 78 % of patients considered the 6WT superior in detecting differences in symptoms (vs. 22% for PROMs). Seventy-six percent of patients would select the 6WT over the other, 18% the ZCQ and 6% the COMI. Eighty-two percent of patients indicated their preference to use a smartphone app for the assessment and monitoring of their spine-related symptoms in the future.Conclusions: Patients included in this study favored the smartphone-based evaluation of objective functional impairment over paper-based PROMs. Involving patients more actively by means of digital technology may increase patient compliance and satisfaction as well as diagnostic accuracy. [ABSTRACT FROM AUTHOR]

Introduction: We developed low-cost, portable paper-based diagnostic devices for detection of human immunoglobulin M (IgM) and immunoglobulin G (IgG) in serum without any sample preparation. These devices can be used to help identify presence of diseases, used to provide rapid results (<5 minutes), readily used by untrained personnel, employed in austere environments, configured to obtain multiplexed assays, and easily disposed of.Materials and Methods: We successfully accomplished colorimetric detection of human IgG and human IgM using a sandwich-style assay within the microfluidic paper device via vertical flow immunoassay configuration. The reaction zone in the wax printed paper layer is a small circular pattern. Gold nanoparticles conjugated with anti-human IgG and IgM antibodies have been used for colorimetric detection of IgG or IgM by naked eye. Colorimetric signal can be precisely quantified through implementation of image analysis software which can be developed as an app for a smartphone. The size of the device is 2 cm × 2 cm × 1 mm.Results: Colorimetric detection of human IgG was accomplished at 100 fg/mL concentration using a gold nanoparticle-conjugated anti-human IgG antibody. The developed platform has a dynamic range of IgM and IgG concentrations between 0.1 pg/mL and 100 μg/mL. These devices provided a color readout in <5 minutes using 20 µL of serum. We also demonstrated that the devices show a significant degree of ruggedness and temperature stability as they were able to provide satisfactory results (detection of 0.1 pg/mL IgG) after 14 days of long stability and shelf-life experiment at an elevated temperature of at least 50 ˚C-the shelf life can be as long as 180 days under ambient conditions for detection of 100 µg/mL IgG.Conclusions: Because of the inherent simplicity of the device operation and their ease of use, there is no variation between samples and users of the device. This low-cost approach enables multiplexing with >1 measurement performed in parallel at the same time. We anticipate that because of the sensitivity, specificity, ease of use, and overall reliability, this approach will become a standard for diagnosis of diseases and health conditions. [ABSTRACT FROM AUTHOR]

Background: A robust medical claims review system is crucial for addressing fraud and abuse and ensuring financial viability of health insurance organisations. This paper assesses claims adjustment rate of the paper- and electronic-based claims reviews of the National Health Insurance Scheme (NHIS) in Ghana.Methods: The study was a cross-sectional comparative assessment of paper- and electronic-based claims reviews of the NHIS. Medical claims of subscribers for the year, 2014 were requested from the claims directorate and analysed. Proportions of claims adjusted by the paper- and electronic-based claims reviews were determined for each type of healthcare facility. Bivariate analyses were also conducted to test for differences in claims adjustments between healthcare facility types, and between the two claims reviews.Results: The electronic-based review made overall adjustment of 17.0% from GHS10.09 million (USD2.64 m) claims cost whilst the paper-based review adjusted 4.9% from a total of GHS57.50 million (USD15.09 m) claims cost received, and the difference was significant (p < 0.001). However, there were no significant differences in claims cost adjustment rate between healthcare facility types by the electronic-based (p = 0.0656) and by the paper-based reviews (p = 0.6484).Conclusions: The electronic-based review adjusted significantly higher claims cost than the paper-based claims review. Scaling up the electronic-based review to cover claims from all accredited care providers could reduce spurious claims cost to the scheme and ensure long term financial sustainability. [ABSTRACT FROM AUTHOR]

Objectives: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants. [ABSTRACT FROM AUTHOR]

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Background: In 2019, a randomized controlled trial (RCT) authored by Dr. Ismail was retracted due to concerns about data integrity. Since there are no policies in place to investigate other publications of authors of retracted studies, we investigated Dr. Ismail's other trials.Methods: We searched for RCTs authored by Dr. Ismail. We made pairwise comparisons of values in baseline and outcome tables between trials. We assessed whether the distributions of baseline characteristics were compatible with properly conducted randomization, using Monte Carlo simulations and the Kolmogorov-Smirnov test. We read the publications carefully for unusual features.Results: Dr. Ismail was author in eight published and one unpublished trial. In three of his first author studies we found multiple identical values in the baseline and/or outcome tables from different trials. At least some of the trials were unlikely to have followed a proper randomization process. There were a number of other unusual features in the papers we reviewed.Conclusions: It is probable that other trials published by Dr. Ismail contain questionable data. We call for a thorough investigation of the original trial data and related official documents. Our exercise suggests that the practice to assess research integrity should include all publications of authors with retracted fabricated articles. [ABSTRACT FROM AUTHOR]

This paper honours a paediatrician whose career has been patchwork but distinguished, with many facets. It is a light-hearted look at the printed (infinitely preferable to the electronic) word. Although the obvious response is "read everything I have written", this would only drive down the stores of Prozac. Read the scientific literature of course. The oldie reads to stay one jump ahead on the ward round. Meta-analyses and systematic reviews rely on the judgement of others, so should be regarded with suspicion. Do your own research, and do not rely on the thoughts of other people. Read beyond PubMed. "There is more in Heaven and Earth, Horatio, than is dreamed of in your PubMed" (Shakespeare). Read the giants of the past. Richard Asher has so much to teach. What are the seven sins of medicine, and how many have you committed? Asher is top read of the talk. Learn from the mistakes of the past. Your patient comes first. Read how the medical profession covered up the death of Steve Biko and never compromise with patient safety and your integrity. Finally, remember thou art mortal - read a real book for pleasure. Kindle reading must be like making love to an inflatable doll (not that I have done either). Choose what you relax with; for me, PG Wodehouse, Jane Austen, Billy Bunter and Wisden. Who said and why: 'Madam, under similar circumstances I would have kicked the Archangel Gabriel!'. [ABSTRACT FROM AUTHOR]

Background: High-frequency patient-reported outcome (PRO) assessments are used to measure patients' symptoms after surgery for surgical research; however, the quality of those longitudinal PRO data has seldom been discussed.Objective: The aim of this study was to determine data quality-influencing factors and to profile error trajectories of data longitudinally collected via paper-and-pencil (P&P) or web-based assessment (electronic PRO [ePRO]) after thoracic surgery.Methods: We extracted longitudinal PRO data with 678 patients scheduled for lung surgery from an observational study (n=512) and a randomized clinical trial (n=166) on the evaluation of different perioperative care strategies. PROs were assessed by the MD Anderson Symptom Inventory Lung Cancer Module and single-item Quality of Life Scale before surgery and then daily after surgery until discharge or up to 14 days of hospitalization. Patient compliance and data error were identified and compared between P&P and ePRO. Generalized estimating equations model and 2-piecewise model were used to describe trajectories of error incidence over time and to identify the risk factors.Results: Among 678 patients, 629 with at least 2 PRO assessments, 440 completed 3347 P&P assessments and 189 completed 1291 ePRO assessments. In total, 49.4% of patients had at least one error, including (1) missing items (64.69%, 1070/1654), (2) modifications without signatures (27.99%, 463/1654), (3) selection of multiple options (3.02%, 50/1654), (4) missing patient signatures (2.54%, 42/1654), (5) missing researcher signatures (1.45%, 24/1654), and (6) missing completion dates (0.30%, 5/1654). Patients who completed ePRO had fewer errors than those who completed P&P assessments (ePRO: 30.2% [57/189] vs. P&P: 57.7% [254/440]; P<.001). Compared with ePRO patients, those using P&P were older, less educated, and sicker. Common risk factors of having errors were a lower education level (P&P: odds ratio [OR] 1.39, 95% CI 1.20-1.62; P<.001; ePRO: OR 1.82, 95% CI 1.22-2.72; P=.003), treated in a provincial hospital (P&P: OR 3.34, 95% CI 2.10-5.33; P<.001; ePRO: OR 4.73, 95% CI 2.18-10.25; P<.001), and with severe disease (P&P: OR 1.63, 95% CI 1.33-1.99; P<.001; ePRO: OR 2.70, 95% CI 1.53-4.75; P<.001). Errors peaked on postoperative day (POD) 1 for P&P, and on POD 2 for ePRO.Conclusions: It is possible to improve data quality of longitudinally collected PRO through ePRO, compared with P&P. However, ePRO-related sampling bias needs to be considered when designing clinical research using longitudinal PROs as major outcomes. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this position paper is two-fold: first, to describe the state of extracorporeal membrane oxygenation education worldwide, noting current limitations and challenges; and second, to put forth an educational agenda regarding opportunities for an international collaborative approach toward standardization.Design: Relevant medical literature was reviewed through literature search, and materials from national organizations were accessed through the Internet. Taskforce members generated a consensus statement using an iterative consensus process through teleconferences and electronic communication.Setting: In 2018, the Extracorporeal Life Support Organization convened the ECMOed Taskforce at two structured, face-to-face meetings of 40 healthcare practitioners and educators with expertise in caring for the extracorporeal membrane oxygenation patient and in extracorporeal membrane oxygenation education.Patients: None.Interventions: None.Measurements and Main Results: The ECMOed Taskforce identified seven educational domains that would benefit from international collaborative efforts. Of primary importance, the Taskforce outlined actionable items regarding 1) the creation of a standardized extracorporeal membrane oxygenation curriculum; 2) defining criteria for an extracorporeal membrane oxygenation course as a vehicle for delivering the curriculum; 3) outlining a mechanism for evaluating the quality of educational offerings; 4) utilizing validated assessment tools in the development of extracorporeal membrane oxygenation practitioner certification; and 5) promoting high-quality educational research to guide ongoing educational and competency assessment development.Conclusions: Significant variability and limitations in global extracorporeal membrane oxygenation education exist. In this position paper, we outline a road map for standardizing international extracorporeal membrane oxygenation education and practitioner certification. Ongoing high-quality educational research is needed to evaluate the impact of these initiatives. [ABSTRACT FROM AUTHOR]

Thin layer chromatography (TLC) is a simple and inexpensive type of chromatography that is extensively used in forensic laboratories for drugs of abuse analysis. In this work, TLC is optimized to analyze cocaine and its adulterants (caffeine, benzocaine, lidocaine and phenacetin) in which the sensitivity (visual determination of LOD from 0.5 to 14mgmL(-1)) and the selectivity (from the study of three different eluents: CHCl3:CH3OH:HCOOHglacial (75:20:5v%), (C2H5)2O:CHCl3 (50:50v%) and CH3OH:NH4OH (100:1.5v%)) were evaluated. Aiming to improve these figures of merit, the TLC spots were identified and quantified (linearity with R(2)>0.98) by the paper spray ionization mass spectrometry (PS-MS), reaching now lower LOD values (>1.0μgmL(-1)). The method developed in this work open up perspective of enhancing the reliability of traditional and routine TLC analysis employed in the criminal expertise units. Higher sensitivity, selectivity and rapidity can be provided in forensic reports, besides the possibility of quantitative analysis. Due to the great simplicity, the PS(+)-MS technique can also be coupled directly to other separation techniques such as the paper chromatography and can still be used in analyses of LSD blotter, documents and synthetic drugs. [ABSTRACT FROM AUTHOR]

Objective: To assess how priority setting exercises for nutrition research are considered in publication.Design: Cross-sectional design.Settings: First, a citation analysis of priority setting exercises found in nutrition research until 2019 was conducted. The reasons for citation were extracted from the text of citing papers and the reasons were defined as: (i) acting on the research questions identified as priorities, (ii) acknowledging the priority setting exercise, (iii) using the same method, or (iv) previous knowledge to support evidence. Second, a survey with authors of the priority setting exercises was done to understand priority setters' perspectives on the impact and satisfaction of their work.Participants: Twenty-one priority setting exercise papers were included. In all, 434 citing papers were found, of which 338 were considered in the citation analysis. A sample of 17 authors representing 13 priority setting exercise papers completed the impact and satisfaction survey.Results: Half of the priority setting exercise papers were published by 2013. After excluding self-citations (n = 60), the priority setting papers had on average 18 citations. Priority setting exercises had a median of 1 (IQR = 0-1) citing manuscript that acted on the recommendations produced from priority setting exercises. Authors of the priority setting exercises expressed a desire for increased uptake of the results of the priority setting exercises by funding agencies. Key barriers for uptake were identified as challenges in involving stakeholders and the general public for participation in the priority setting exercise.Conclusions: Priority settings exercises are important efforts to guide nutrition research toward effective allocation of resources. However, there seems to be a limited consideration of these priority setting exercises in research papers. [ABSTRACT FROM AUTHOR]

The Phadebas® Forensic Press Test is routinely used for the detection of saliva. However, assessment of the use of Phadebas® paper for this purpose has not been studied extensively. The suitability of Phadebas® paper as a presumptive screening tool for saliva on forensic exhibits, was investigated by analysing the following: (1) sensitivity, (2) specificity, (3) effects of temperature on sensitivity and specificity, (4) detection of saliva in mixed body fluid samples, and (5) influence of substrate porosity. The results of this study demonstrated that Phadebas® paper is more sensitive to α-amylase activity and less specific for saliva than previously reported. The use of an examination temperature of 37°C had no effect on sensitivity, but increased the incidence of cross-reactivity with other forensically relevant body fluid stains. Blood, urine and vaginal secretions can inhibit the detection of α-amylase activity with Phadebas® paper in mixed stains of saliva and body fluid. Substrate porosity is a weak predictor for the time taken for a saliva stain to achieve a strong positive result on Phadebas® paper. Overall, this study demonstrated that the Phadebas® Forensic Press Test has limitations as a presumptive test for the accurate identification of saliva. [ABSTRACT FROM AUTHOR]

Objective: To determine the level of agreement of disease flare severity (distinguishing severe, moderate, and mild flare and persistent disease activity) in a large paper-patient exercise involving 988 individual cases of systemic lupus erythematosus.Methods: A total of 988 individual lupus case histories were assessed by 3 individual physicians. Complete agreement about the degree of flare (or persistent disease activity) was obtained in 451 cases (46%), and these provided the reference standard for the second part of the study. This component used 3 flare activity instruments (the British Isles Lupus Assessment Group [BILAG] 2004, Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA] flare index [SFI] and the revised SELENA flare index [rSFI]). The 451 patient case histories were distributed to 18 pairs of physicians, carefully randomized in a manner designed to ensure a fair case mix and equal distribution of flare according to severity.Results: The 3-physician assessment of flare matched the level of flare using the 3 indices, with 67% for BILAG 2004, 72% for SFI, and 70% for rSFI. The corresponding weighted kappa coefficients for each instrument were 0.82, 0.59, and 0.74, respectively. We undertook a detailed analysis of the discrepant cases and several factors emerged, including a tendency to score moderate flares as severe and persistent activity as flare, especially when the SFI and rSFI instruments were used. Overscoring was also driven by scoring treatment change as flare, even if there were no new or worsening clinical features.Conclusion: Given the complexity of assessing lupus flare, we were encouraged by the overall results reported. However, the problem of capturing lupus flare accurately is not completely solved. [ABSTRACT FROM AUTHOR]

Although the use of theories and evidence is often stressed in the development of health promotion interventions, this does not guarantee the success of an intervention. Thus, we need to reflect on intervention development processes that use different types of theories and evidence. In this paper, we provide a reflective discussion on how we identified evidence-based behavior change techniques and counseling themes for a health promotion intervention. In addition, we discuss the challenges that we encountered and what we learned during the process: a) a lack of previous research and meta-analyses, b) inconsistencies in evidence, c) integrating evidence and theories that have different starting points, and d) collaborating with researchers who represent different evidence and theories. During the process, we benefitted from having the clear goal of conducting evidence- and theory-based work. We solved the challenges by, for example, utilizing different types of evidence and being reflective about the reasons behind any inconsistencies in the evidence. In retrospect, we would have benefitted from closer collaboration between the teams that worked separately with different evidence. These kinds of reflective descriptions of development processes and the challenges encountered during them may help other researchers and professionals avoid encountering the same challenges. [ABSTRACT FROM AUTHOR]

Background: Accurate quantification of pain in a clinical setting is vital. The use of an electronic pain scale enables data to be collected, analyzed, and utilized much faster compared with traditional paper-based scales. The advancement of smart technology in pediatric and adult pain evaluation may offer opportunities to introduce easy-to-use and reliable pain assessment methods within different clinical settings. If promptly introduced within different pediatric and adult pain clinic services, validated and easily accessible mobile health pain apps may lead to early pain detection, promoting improvement in patient's quality of life and leading to potentially less time off from school or work.Objective: This cross-sectional observational study aimed to investigate the interchangeability of an electronic visual analog scale (eVAS) app with a traditional paper visual analog scale (pVAS) among Australian children, adolescents, and adults for pain evaluation.Methods: Healthy participants (age range 10-75 years) were recruited from a sporting club and a secondary school in Melbourne (Australia). The data collection process involved application of pressure (8.5 kg/cm2) from a Wagner Force Dial FDK 20 to the midpoint of the thumb. The pressure was applied twice with a 5-minute interval. At each pressure application, participants were asked to randomly record their pain perception using the "eVAS" accessible via the "Interactive Clinics" app and the traditional pVAS. Statistical analysis was conducted to determine intermethod and intramethod reliabilities.Results: Overall, 109 healthy participants were recruited. Adults (mean age 42.43 years, SD 14.50 years) had excellent reliability, with an intraclass correlation coefficient (ICC) of 0.94 (95% CI 0.91-0.96). Children and adolescents (mean age 13.91 years, SD 2.89 years) had moderate-to-good intermethod and intramethod reliabilities, with an ICC of 0.80 (95% CI 0.70-0.87) and average ICC of 0.80 (95% CI 0.69-0.87), respectively.Conclusions: The eVAS app appears to be interchangeable compared with the traditional pVAS among children, adolescents, and adults. This pain evaluation method may offer new opportunities to introduce user-friendly and validated pain assessment apps for patients, clinicians, and allied health professionals. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer screening by fecal occult blood testing has been an important public health test and shown to reduce colorectal cancer-related mortality. However, the low participation rate in colorectal cancer screening by the general public remains a problematic public health issue. This fact could be attributed to the complex and unpleasant operation of the screening tool.Objective: This study aimed to validate a novel toilet paper-based point-of-care test (ie, JustWipe) as a public health instrument to detect fecal occult blood and provide detailed results from the evaluation of the analytic characteristics in the clinical validation.Methods: The mechanism of fecal specimen collection by the toilet-paper device was verified with repeatability and reproducibility tests. We also evaluated the analytical characteristics of the test reagents. For clinical validation, we conducted comparisons between JustWipe and other fecal occult blood tests. The first comparison was between JustWipe and typical fecal occult blood testing in a central laboratory setting with 70 fecal specimens from the hospital. For the second comparison, a total of 58 volunteers were recruited, and JustWipe was compared with the commercially available Hemoccult SENSA in a point-of-care setting.Results: Adequate amounts of fecal specimens were collected using the toilet-paper device with small day-to-day and person-to-person variations. The limit of detection of the test reagent was evaluated to be 3.75 µg of hemoglobin per milliliter of reagent. Moreover, the test reagent also showed high repeatability (100%) on different days and high reproducibility (>96%) among different users. The overall agreement between JustWipe and a typical fecal occult blood test in a central laboratory setting was 82.9%. In the setting of point-of-care tests, the overall agreement between JustWipe and Hemoccult SENSA was 89.7%. Moreover, the usability questionnaire showed that the novel test tool had high scores in operation friendliness (87.3/100), ease of reading results (97.4/100), and information usefulness (96.1/100).Conclusions: We developed and validated a toilet paper-based fecal occult blood test for use as a point-of-care test for the rapid (in 60 seconds) and easy testing of fecal occult blood. These favorable characteristics render it a promising tool for colorectal cancer screening as a public health instrument. [ABSTRACT FROM AUTHOR]

Background: Electronic data collection is increasingly being used for discrete choice experiments (DCEs).Objectives: To study whether paper or electronic administration results in measurement effects.Methods: Respondents were drawn from the same sample frame (an Internet panel) and completed a nearly identical DCE survey either online or on paper during the same period. A DCE on preferences for basic health insurance served as a case study. We used panel mixed logit models for the analysis.Results: In total, 898 respondents completed the survey: 533 respondents completed the survey online, whereas 365 respondents returned the paper survey. There were no significant differences with respect to sociodemographic characteristics between the respondents in both samples. The median response time was shorter for the online sample than for the paper sample, and a smaller proportion of respondents from the online sample were satisfied with the number of choice sets. Although some willingness- to-pay estimates were higher for the online sample, the elicited preferences for basic health insurance characteristics were similar between both modes of administration.Conclusions: We find no indication that online surveys yield inferior results compared with paper-based surveys, whereas the price per respondent is lower for online surveys. Researchers might want to include fewer choice sets per respondent when collecting DCE data online. Because our findings are based on a nonrandomized DCE that covers one health domain only, research in other domains is needed to support our findings. [ABSTRACT FROM AUTHOR]

Background: The collection of subgingival plaque samples with paper points is time-consuming and accident-sensitive. However, the collection of saliva is simple and contains pathogens of all intraoral surfaces. The aim of this study is to investigate whether a sampling strategy with mouthrinse (mouthrinse sample [MSP]; test) leads to results comparable with standard sampling method (multiple site test from the deepest pocket of each quadrant [MT4]; control).Methods: In 50 patients with periodontitis, subgingival plaque was sampled from the deepest pocket of each quadrant by using paper points and by gaining saliva with saline mouthrinse. Analysis was performed using a commercially available polymerase chain reaction test for 11 periodontal pathogens.Results: Detection frequency of Aggregatibacter actinomycetemcomitans (MT4/MSP: 42%/36%), Porphyromonas gingivalis (78%/66%), Tannerella forsythia (98%/84%), Treponema denticola (94%/74%), Parvimonas micra (86%/62%), Campylobacter rectus (90%/76%), Eubacterium nodatum (64%/30%), Prevotella intermedia (58%/54%), and Eikenella corrodens (90%/82%) was higher with MT4 than MSP. For Fusobacterium nucleatum (100%/100%), there was no difference between test and control. Only detection frequency of Capnocytophaga species (68%/74%) was higher with MSP than MT4. Differences were significant for P. gingivalis, T. forsythia, T. denticola, P. micra, C. rectus, and E. nodatum.Conclusions: There is no significant difference between MT4 and MSP for detection frequency of key pathogen A. actinomycetemcomitans. Key pathogens P. gingivalis, T. forsythia, T. denticola, P. micra, C. rectus, and E. nodatum show statistically higher detection frequencies with MT4. [ABSTRACT FROM AUTHOR]

Background: Clinical free-text data (eg, outpatient letters or nursing notes) represent a vast, untapped source of rich information that, if more accessible for research, would clarify and supplement information coded in structured data fields. Data usually need to be deidentified or anonymized before they can be reused for research, but there is a lack of established guidelines to govern effective deidentification and use of free-text information and avoid damaging data utility as a by-product.Objective: This study aimed to develop recommendations for the creation of data governance standards to integrate with existing frameworks for personal data use, to enable free-text data to be used safely for research for patient and public benefit.Methods: We outlined data protection legislation and regulations relating to the United Kingdom for context and conducted a rapid literature review and UK-based case studies to explore data governance models used in working with free-text data. We also engaged with stakeholders, including text-mining researchers and the general public, to explore perceived barriers and solutions in working with clinical free-text.Results: We proposed a set of recommendations, including the need for authoritative guidance on data governance for the reuse of free-text data, to ensure public transparency in data flows and uses, to treat deidentified free-text data as potentially identifiable with use limited to accredited data safe havens, and to commit to a culture of continuous improvement to understand the relationships between the efficacy of deidentification and reidentification risks, so this can be communicated to all stakeholders.Conclusions: By drawing together the findings of a combination of activities, we present a position paper to contribute to the development of data governance standards for the reuse of clinical free-text data for secondary purposes. While working in accordance with existing data governance frameworks, there is a need for further work to take forward the recommendations we have proposed, with commitment and investment, to assure and expand the safe reuse of clinical free-text data for public benefit. [ABSTRACT FROM AUTHOR]

Keywords: electronic health record; health information technology; implementation; lung cancer screening; lung cancer screening software; tracking EN electronic health record health information technology implementation lung cancer screening lung cancer screening software tracking 1674 1679 6 05/23/20 20200601 NES 200601 Problem Statement The development of a high-quality lung cancer screening (LCS) program poses many operational challenges. Sophisticated EHRs and integrated LCS software systems should universally support established practice standards in the most basic LCS services and more comprehensive LCS programs. Most proprietary LCS software systems are designed to capture and transfer digital imaging and radiology report information from local or independent diagnostic testing facilities, and autopopulate and autointegrate LCS patient and imaging data into the LCS software system. Thus, information regarding the patient's navigation through the LCS program may not be accessible to providers who have access to the EHR but who do not have access to the LCS software system. [Extracted from the article]

Objectives: DETERMIND (DETERMinants of quality of life, care and costs, and consequences of INequalities in people with Dementia and their carers) is designed to address fundamental, and, as yet unanswered questions about inequalities, outcomes and costs following diagnosis with dementia. These answers are needed to improve the quality of care and equity of access to care, and therefore the quality of life, of people with dementia and their carers.Method: DETERMIND is a programme of research consisting of seven complementary workstreams (WS) exploring various components that may result in unequal dementia care: WS1: Recruitment and follow-up of the DETERMIND cohort-900 people with dementia and their carers from three geographically and socially diverse sites within six months following diagnosis, and follow them up for three years. WS2: Investigation of the extent of inequalities in access to dementia care. WS3: Relationship between use and costs of services and outcomes. WS4: Experiences of self-funders of care. WS5: Decision-making processes for people with dementia and carers. WS6: Effect of diagnostic stage and services on outcomes. WS7: Theory of Change informed strategy and actions for applying the research findings.Outcomes: During the life of the programme, analysing baseline results and then follow-up of the DETERMIND cohort over 3 years, we will establish evidence on current services and practice. DETERMIND will deliver novel, detailed data on inequalities in dementia care and what drives positive and negative outcomes and costs for people with dementia and carers, and identify factors that help or hinder living well with dementia. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device).Methods: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire.Results: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference).Conclusions: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach. [ABSTRACT FROM AUTHOR]

Background: Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults.Methods: This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12.Discussion: The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during dietary energy-restricted weight loss in overweight and obese older adults.Trial Registration: The trial was registered on the Australia New Zealand Clinical Trials Register ( ACTRN12616001400459 ); Trial registration date: 10th October, 2016. [ABSTRACT FROM AUTHOR]

Purpose: Knee-specific patient reported outcome measures (PROMs) are important tools in evaluating the effectiveness of sports medicine interventions. The PROMs were originally developed for paper administration, but electronic data capture technologies offer potential benefits such as increased efficiency and accuracy. The aim of this study was to assess the validity of touch screen versus paper administration using several common knee-specific and general health surveys.Methods: Agreement between scores was compared for knee-specific PROMs administered on paper versus computer; paper versus tablet; computer versus tablet in 60 patients per group undergoing ACL reconstruction. Surveys were given at pre-operative assessment and between 1 and 7 days later. Weighted kappa statistic (κ) and intraclass correlation coefficients (ICC) were calculated to test agreement between the two modalities in: IKDC Subjective Knee Form, Marx Activity Scale, Tegner Activity Level Scale, and Lysholm Knee Scale. SF-12 Physical and Mental Component Summary scores were also assessed.Results: Response rate was over 90 %. Mean age was 29.6 ± 10.9 years, with patients in the paper-computer cohort being 4 years older than in the other groups. Agreement was substantial or better for all PROMs collected: IKDC Subjective (ICC: 0.79); Marx (ICC: 0.70); Lysholm (ICC: 0.65); and Tegner (κ = 0.67). Agreement for the SF-12 PCS (ICC: 0.77) and MCS (ICC: 0.73) was also found to have substantial agreement.Conclusion: In conclusion, touch screen-based PROMs are a valid capture method, providing reliable results relative to traditional paper survey administration. Digital methods of direct data capture may also foster multi-centre collaborations and allow for more accurate comparisons of outcomes between patient groups in clinical practice and orthopaedic research.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of magnesium sulfate for prevention of eclampsia on blood loss at time of cesarean delivery (CD). Methods: We conducted an electronic based search using the following databases: MEDLINE, PUBMED and the Cochrane Library. The search terms were “magnesium sulfate”, “preeclampsia” and “randomized”. Inclusion criteria were randomized controlled trials of women with preeclampsia who delivered with or without magnesium sulfate therapy for seizure prophylaxis. Only trials with placebo or no treatment comparison groups were included. Primary outcome was postpartum hemorrhage. Secondary outcomes were estimated blood loss, change in hemoglobin, blood transfusion and eclampsia. Results: Five trials met inclusion criteria. The incidence of postpartum hemorrhage was similar between the two groups [magnesium sulfate: 754/4482 (17%); no magnesium sulfate: 775/4427 (18%); RR 0.97, 95% CI 0.88–1.06]. There was no statistical difference between any of the other blood loss outcomes reported in the included studies. The rate of eclampsia with magnesium sulfate was significantly lower than with placebo (42/5604, 0.7%, versus 107/5600, 1.9%; RR 0.40, 95% CI 0.28–0.57). Conclusions: Magnesium sulfate does not appear to affect blood loss intrapartum and postpartum in women with preeclampsia. Magnesium sulfate, therefore, should be continued during CD, given the benefit of seizure prophylaxis without any increased risk of hemorrhage. [ABSTRACT FROM PUBLISHER]

Context: Researchers administering surveys seek to balance data quality, sources of error, and practical concerns when selecting an administration mode. Rarely are decisions about survey administration based on the background of study participants, although socio-demographic characteristics like age, education, and race may contribute to participants' (non)responses.Objectives: In this study, we describe differences in paper- and web-based surveys administered in a national cancer survivor study of women with a history of cancer to compare the ability of each survey administrative mode to provide quality, generalizable data.Methods: We compared paper- and web-based survey data by socio-demographic characteristics of respondents, missing data rates, scores on primary outcome measure, and administrative costs and time using descriptive statistics, tests of mean group differences, and linear regression.Results: Our findings indicate that more potentially vulnerable patients preferred paper questionnaires and that data quality, responses, and costs significantly varied by mode and participants' demographic information. We provide targeted suggestions for researchers conducting survey research to reduce survey error and increase generalizability of study results to the patient population of interest.Conclusion: Researchers must carefully weigh the pros and cons of survey administration modes to ensure a representative sample and high-quality data. [ABSTRACT FROM AUTHOR]

Background: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.Methods: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.Results: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.Conclusion: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. [ABSTRACT FROM AUTHOR]

Objective: Most preventable adverse drug events and medication errors occur during medication ordering. Medication order entry and clinical decision support are available on paper or as computerized systems. In this post-hoc analysis we investigated frequency and clinical impact of blood glucose (BG) documentation- and user-related calculation errors as well as workflow deviations in diabetes management. We aimed to compare a paper-based protocol to a computerized medication management system combined with clinical workflow and decision support.Methods: Seventy-nine hospitalized patients with type 2 diabetes mellitus were treated with an algorithm driven basal-bolus insulin regimen. BG measurements, which were the basis for insulin dose calculations, were manually entered either into the paper-based workflow protocol (PaperG: 37 patients) or into GlucoTab(®)-a mobile tablet PC based system (CompG: 42 patients). We used BG values from the laboratory information system as a reference. A workflow simulator was used to determine user calculation errors as well as workflow deviations and to estimate the effect of errors on insulin doses. The clinical impact of insulin dosing errors and workflow deviations on hypo- and hyperglycemia was investigated.Results: The BG documentation error rate was similar for PaperG (4.9%) and CompG group (4.0%). In PaperG group, 11.1% of manual insulin dose calculations were erroneous and the odds ratio (OR) of a hypoglycemic event following an insulin dosing error was 3.1 (95% CI: 1.4-6.8). The number of BG values influenced by insulin dosing errors was eightfold higher than in the CompG group. In the CompG group, workflow deviations occurred in 5.0% of the tasks which led to an increased likelihood of hyperglycemia, OR 2.2 (95% CI: 1.1-4.6).Discussion: Manual insulin dose calculations were the major source of error and had a particularly strong influence on hypoglycemia. By using GlucoTab(®), user calculation errors were entirely excluded. The immediate availability and automated handling of BG values from medical devices directly at the point of care has a high potential to reduce errors. Computerized systems facilitate the safe use of more complex insulin dosing algorithms without compromising usability. In CompG group, missed or delayed tasks had a significant effect on hyperglycemia, while in PaperG group insufficient precision of documentation times limited analysis. The use of old BG measurements was clinically less relevant.Conclusion: Insulin dosing errors and workflow deviations led to measurable changes in clinical outcome. Diabetes management systems including decision support should address nurses as well as physicians in a computerized way. Our analysis shows that such systems reduce the frequency of errors and therefore decrease the probability of hypo- and hyperglycemia. [ABSTRACT FROM AUTHOR]

Integration of e-Health technologies for purposes of both assessment and intervention has recently become an interest area in pediatric psychology. The purpose of this study is to present psychometric characteristics of a technology-based (i.e., tablet administration) approach for measuring quality of life (QOL) in children. Eighty children (8-12 years) completed the Quality of Life Systemic Inventory for Children (QLSI-C) twice over a 2-week delay, in a crossover design that used paper and tablet-based modes of administration. Equivalence of scores across methods was examined using intraclass correlation coefficients (ICC), augmented by paired t test and Pearson's correlations. Test-retest reliability was assessed using paired t test and Pearson's correlations while internal consistency was assessed using Cronbach's coefficient. Results showed a good concordance across methods of administration (ICCs = .72 to .91; r = .56 to .83). Paired t test showed no significant differences between the tablet and paper version of the QLSI-C. Internal consistency reliability yielded acceptable Cronbach's alphas for all QLSI-C scores, with all α > .70. Test-retest reliability for the tablet-administered QLSI-C was good (r = .66 to .90). Paired t test showed no significant difference between Time 1 and 2 for the QLSI-C scores, except for the state score. Findings established the reliability of the tablet-administered QLSI-C scores. This technology approach to assessment is more attractive for children, decreases time for administration, and enhances the ease of scoring. These advantages might encourage both clinicians and researchers to consider using e-Health developments in assessment in pediatric psychology. (PsycINFO Database Record [ABSTRACT FROM AUTHOR]

Aim: The aim of this article was to develop and apply an Internet-based headache diary (i-diary) for adolescents and compare it with a paper-diary (p-diary) regarding adherence, user acceptability and recorded headache activity.Methods: In a cross-sectional school-based study, a representative sample of 488 adolescents aged 12-18 years were randomly allocated by cluster sampling to record for three weeks in i-diaries or p-diaries their headache intensity, disability, and use of acute medication.Results: A significantly (p = 0.008) higher proportion of adolescents in the i-diary group used the diary at least once during the 21-day period (86% vs 76% for the p-diary). However, the p-diary group completed a significantly (p < 0.001) higher number of diary days (20.8 vs 15.0 days for the i-diary). The response rate for the i-diary-group was largely evenly distributed over the study period; conversely, approximately two-thirds of the adolescents using the p-diary responded on all 21 days, whereas one-fourth did not respond at all. The two diary types were rated as equal in easiness to remember (p = 0.25), but the i-diaries were more bothersome to use (p = 0.029).Conclusion: Although p-diary users completed a higher proportion of diary days, i-diaries provided more reliable and credible estimates of headache parameters because of better real-time assessment. [ABSTRACT FROM AUTHOR]

Purpose: To validate electronic versions of the Mini Pediatric and Pediatric Asthma Caregiver's Quality of Life Questionnaires (MiniPAQLQ and PACQLQ, respectively), determine completion times and correlate QOL of children and caregivers.Methods: A total of 63 children and 64 caregivers completed the paper and electronic MiniPAQLQ or PACQLQ. Agreement between versions of each questionnaire was summarized by intraclass correlation coefficients (ICC). The correlation between MiniPAQLQ and PACQLQ scores from child-caregiver pairs was assessed using Pearson's correlation coefficient.Results: There was no significant difference (mean difference = 0.1, 95% CI -0.1, 0.2) in MiniPAQLQ Overall Scores between paper (5.9 ± 1.0, mean ± SD) and electronic (5.8 ± 1.0) versions, or any of the domains. ICCs ranged from 0.89 (Overall) to 0.86 (Emotional Function). Overall PACQLQ scores for both versions were comparable (5.9 ± 0.9 and 5.8 ± 1.0; mean difference = 0.0; 95% CI -0.1, 0.2). ICCs ranged from 0.81 (Activity Limitation) to 0.88 (Emotional Function). The electronic PACQLQ took 26 s longer (95% CI 11, 41; p < 0.001). Few participants (3-11%) preferred the paper format. MiniPAQLQ and PACQLQ scores were significantly correlated (all p < 0.05) for Overall (r paper = 0.33, r electronic = 0.27) and Emotional Function domains (r paper = 0.34, r electronic = 0.29).Conclusions: These electronic QOL questionnaires are valid, and asthma-related QOL of children and caregivers is related. [ABSTRACT FROM AUTHOR]

Objective: Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection.Study Design: This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians.Results: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01).Conclusions: Participants reporting bleeding via text messages provided more complete data than women using paper diaries.Implications: Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Background: The adoption and use of health information technology (IT) continues to grow around the globe. In Switzerland, the government nor professional associations have to this day provided incentives for health IT adoption.Objective: We aim to assess the proportion of physicians who are routinely working with electronic health data and describe to what extent physicians exchange electronic health data with peers and other health care providers. Additionally, we aim to estimate the effect of physicians' attitude towards health IT on the adoption of electronic workflows.Methods: Between May and July 2013, we conducted a cross-sectional survey of 1200 practice based physicians in Switzerland. Respondents were asked to report on their technical means and where applicable their paper-based workarounds to process laboratory data, examination results, referral letters and physician's letters. Physicians' view of barriers and facilitators towards health IT use was determined by a composite score.Results: A response rate of 57.1% (n=685) was reached. The sample was considered to be representative for physicians in Swiss ambulatory care. 35.2% of the respondents documented patients' health status with the help of a longitudinal semi-structured electronic text record generated by one or more encounters in the practice. Depending on the task within a workflow, around 11-46% of the respondents stated to rely on electronic workflow practices to process laboratory and examination data and dispatch referral notes and physician's letters. The permanent use of electronic workflow processes was infrequent. Instead, respondents reported paper-based workarounds affecting specific tasks within a workflow. Physicians' attitude towards health IT was significantly associated with the adoption of electronic workflows (OR 1.04-1.31, p<0.05), but the effect sizes of factors related to the working environment (e.g., regional factors, medical specialty, type of practice) were larger.Conclusion: At present, only a few physicians in Swiss ambulatory care routinely work with electronic health data. Until more of their peers participate in electronic exchange of structured clinical information, most physicians will continue to stay in paper-based systems and workarounds. The survey found that physicians with a positive attitude towards health IT were more likely to adopt electronic workflows, but the impact is minor. It will likely be necessary to introduce financial incentives and develop national standards in order to promote the adoption by a critical mass of practicing clinicians. [ABSTRACT FROM AUTHOR]

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges.Objective: The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns.Methods: Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs.Results: Of the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure.Conclusions: The findings suggest that mental health e-screening is feasible and acceptable to pregnant women.Trial Registration: Clinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb). [ABSTRACT FROM AUTHOR]

The study was conducted to assess whether the introduction of an electronic patient records-based system affected hepatitis B vaccination completion rates and post-vaccination return rates, when compared to a paper-based system. Data were gathered for three groups of patients: those commencing vaccination (a) when paper records were in use (paper records group), (b) after electronic patient records were introduced (basic electronic patient records group) and (c) after electronic patient records were enhanced with recall (enhanced electronic patient records group). Compared to the paper records group, the third dose completion rates for patients managed using electronic patient records did not differ significantly: 74/119 (62.2%) paper vs. 58/98 (59.2%) basic electronic patient records, p = 0.652 and 89/130 (68.5%) enhanced electronic patient records, p = 0.298. On sub-group analysis, completion rates in patients of black ethnicity in the enhanced electronic patient records group were significantly higher than those in the paper records group: 16/19 (84.2%) enhanced electronic patient records vs. 11/23 (47.8%) paper, p = 0.014. Patients in the enhanced electronic patient records group were more likely than those in the paper records group to attend for measurement of hepatitis B surface antibody levels: 61/130 (46.9%) vs. 39/119 (32.8%), p = 0.023. [ABSTRACT FROM AUTHOR]