Investigation of bias due to selective inclusion of study effect estimates in meta-analyses of nutrition research.

We aimed to explore, in a sample of systematic reviews (SRs) with meta-analyses of the association between food/diet and health-related outcomes, whether systematic reviewers selectively included study effect estimates in meta-analyses when multiple effect estimates were available. We randomly selected SRs of food/diet and health-related outcomes published between January 2018 and June 2019. We selected the first presented meta-analysis in each review (index meta-analysis), and extracted from study reports all study effect estimates that were eligible for inclusion in the meta-analysis. We calculated the Potential Bias Index (PBI) to quantify and test for evidence of selective inclusion. The PBI ranges from 0 to 1; values above or below 0.5 suggest selective inclusion of effect estimates more or less favourable to the intervention, respectively. We also compared the index meta-analytic estimate to the median of a randomly constructed distribution of meta-analytic estimates (i.e., the estimate expected when there is no selective inclusion). Thirty-nine SRs with 312 studies were included. The estimated PBI was 0.49 (95% CI 0.42-0.55), suggesting that the selection of study effect estimates from those reported was consistent with a process of random selection. In addition, the index meta-analytic effect estimates were similar, on average, to what we would expect to see in meta-analyses generated when there was no selective inclusion. Despite this, we recommend that systematic reviewers report the methods used to select effect estimates to include in meta-analyses, which can help readers understand the risk of selective inclusion bias in the SRs.

Implementing a Family-Centered Rounds Intervention Using Novel Mentor-Trios.

BACKGROUND AND OBJECTIVES: Patient and Family Centered I-PASS (PFC I-PASS) emphasizes family and nurse engagement, health literacy, and structured communication on family-centered rounds organized around the I-PASS framework (Illness severity-Patient summary-Action items-Situational awareness-Synthesis by receiver). We assessed adherence, safety, and experience after implementing PFC I-PASS using a novel "Mentor-Trio" implementation approach with multidisciplinary parent-nurse-physician teams coaching sites. METHODS: Hybrid Type II effectiveness-implementation study from 2/29/19-3/13/22 with ≥3 months of baseline and 12 months of postimplementation data collection/site across 21 US community and tertiary pediatric teaching hospitals. We conducted rounds observations and surveyed nurses, physicians, and Arabic/Chinese/English/Spanish-speaking patients/parents. RESULTS: We conducted 4557 rounds observations and received 2285 patient/family, 1240 resident, 819 nurse, and 378 attending surveys. Adherence to all I-PASS components, bedside rounding, written rounds summaries, family and nurse engagement, and plain language improved post-implementation (13.0%-60.8% absolute increase by item), all P < .05. Except for written summary, improvements sustained 12 months post-implementation. Resident-reported harms/1000-resident-days were unchanged overall but decreased in larger hospitals (116.9 to 86.3 to 72.3 pre versus early- versus late-implementation, P = .006), hospitals with greater nurse engagement on rounds (110.6 to 73.3 to 65.3, P < .001), and greater adherence to I-PASS structure (95.3 to 73.6 to 72.3, P < .05). Twelve of 12 measures of staff safety climate improved (eg, "excellent"/"very good" safety grade improved from 80.4% to 86.3% to 88.0%), all P < .05. Patient/family experience and teaching were unchanged. CONCLUSIONS: Hospitals successfully used Mentor-Trios to implement PFC I-PASS. Family/nurse engagement, safety climate, and harms improved in larger hospitals and hospitals with better nurse engagement and intervention adherence. Patient/family experience and teaching were not affected.

Variation observed in consensus judgments between pairs of reviewers when assessing the risk of bias due to missing evidence in a sample of published meta-analyses of nutrition research.

OBJECTIVES: To evaluate the risk of bias due to missing evidence in a sample of published meta-analyses of nutrition research using the Risk Of Bias due to Missing Evidence (ROB-ME) tool and determine inter-rater agreement in assessments. STUDY DESIGN AND SETTING: We assembled a random sample of 42 meta-analyses of nutrition research. Eight assessors were randomly assigned to one of four pairs. Each pair assessed 21 randomly assigned meta-analyses, and each meta-analysis was assessed by two pairs. We calculated raw percentage agreement and chance corrected agreement using Gwet's Agreement Coefficient (AC) in consensus judgments between pairs. RESULTS: Across the eight signaling questions in the ROB-ME tool, raw percentage agreement ranged from 52% to 100%, and Gwet's AC ranged from 0.39 to 0.76. For the risk-of-bias judgment, the raw percentage agreement was 76% (95% confidence interval 60% to 92%) and Gwet's AC was 0.47 (95% confidence interval 0.14 to 0.80). In seven (17%) meta-analyses, either one or both pairs judged the risk of bias due to missing evidence as "low risk". CONCLUSION: Our findings indicated substantial variation in assessments in consensus judgments between pairs for the signaling questions and overall risk-of-bias judgments. More tutorials and training are needed to help researchers apply the ROB-ME tool more consistently.

Disclosure of funding sources and conflicts of interest in evidence underpinning vitamin D and calcium recommendations in bone health guidelines.

OBJECTIVE: The present study aims to examine the relationship between study funding sources, author conflicts of interest (COI) and conclusions in studies supporting vitamin D and Ca intake cited in bone health guideline recommendations. DESIGN: Cross-sectional. SETTING: Forty-seven global bone health guidelines with vitamin D and/or Ca recommendations for adults aged 40 years and above. PARTICIPANTS: The evidence cited to support the recommendations was extracted by two independent reviewers and classified by type of recommendation, article characteristics, study design, types of funding sources and conflict of interest (COI) disclosure and direction of study conclusions. RESULTS: Of 156 articles cited to support the bone health recommendations, 120 (77 %) disclosed a funding source, and 43 (28 %) declared that at least one author had a COI. Compared with articles with non-commercial or no funding source, those funded by commercial sponsors tended to have a study conclusion favourable towards vitamin D/Ca (relative risk (95 % CI): 1·32 (0·94, 1·87), P = 0·16), but the association was not statistically significant (Fisher's exact test). Compared to those with a COI disclosure statement, articles with missing or unclear COI disclosure were more likely to have favourable conclusions (1·56 (1·05, 2·31), P = 0·017) (Fisher's exact test). CONCLUSION: In the evidence underpinning a sample of global bone health guidelines, COI disclosure was low and studies with missing or unclear COI disclosures were more likely to have favourable study conclusions than those with disclosures, suggesting a need for greater transparency of COI in bone health guidelines.

Methods used to select results to include in meta-analyses of nutrition research: A meta-research study.

OBJECTIVES: To investigate how often review authors encounter multiple results from included studies that are eligible for inclusion in a particular meta-analysis, and how often methods to select results are specified. METHODS: MEDLINE and Epistemonikos were searched (January 2018-June 2019) to identify systematic reviews with meta-analysis of the association between food/diet and health-related outcomes. A random sample of these reviews was selected, and for the first presented (index) meta-analysis, rules used to select effect estimates to include in this meta-analysis were extracted from the reviews and their protocols. All effect estimates from the primary studies that were eligible for inclusion in the index meta-analyses were extracted (e.g., when a study report presented effect estimates for blood pressure at 3 weeks and 6 weeks, both unadjusted and adjusted for covariates, and all were eligible for inclusion in a meta-analysis of the effect of red meat consumption on blood pressure, we extracted all estimates, and classified the study as having "multiplicity of results"). RESULTS: Forty-two systematic reviews with 325 studies (104 randomized, 221 non-randomized) were included; 14 reviews had a protocol. In 29% of review protocols and 69% of reviews, authors specified at least one decision rule to select effect estimates when multiple were available. In 68% of studies included in the index meta-analyses, there was at least one type of multiplicity of results. CONCLUSIONS: Authors of systematic reviews of nutrition studies should anticipate encountering multiplicity of results in the included primary studies. Specification of methods to handle multiplicity when designing reviews is therefore recommended.

Assessment of the Methods Used to Develop Vitamin D and Calcium Recommendations-A Systematic Review of Bone Health Guidelines.

BACKGROUND: There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. METHODS: We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development; and, identified types identified types of evidence underpinning the recommendations. RESULTS: we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9-12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. CONCLUSIONS: There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health.

Cross-sectional study of preprints and final journal publications from COVID-19 studies: discrepancies in results reporting and spin in interpretation.

OBJECTIVE: To compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications. DESIGN: Cross-sectional study. SETTING: International medical literature. PARTICIPANTS: Preprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020. MAIN OUTCOME MEASURES: Study characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably). RESULTS: Of 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study. CONCLUSIONS: The COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.

Association of food industry ties with findings of studies examining the effect of dairy food intake on cardiovascular disease and mortality: systematic review and meta-analysis.

OBJECTIVE: To determine if the association of dairy foods with cardiovascular disease (CVD) outcomes differs between studies with food industry ties versus those without industry ties. To determine whether studies with or without industry ties differ in their risk of bias. ELIGIBILITY CRITERIA: We included cohort and case-control studies that estimated the association of dairy foods with CVD outcomes in healthy adults. INFORMATION SOURCES: We searched eight databases on 1 February 2019 from 2000 to 2019 and hand searched reference lists. RISK OF BIAS: We used the Risk of Bias in Non-Randomised Studies-of Exposure tool. INCLUDED STUDIES: 43 studies (3 case-controls, 40 cohorts). SYNTHESIS OF RESULTS: There was no clear evidence of an association between studies with industry ties (1/14) versus no industry ties (8/29) and the reporting of favourable results, risk ratio (RR)=0.26 (95% CI 0.04 to 1.87; n=43 studies) and studies with industry ties (4/14) versus no industry ties (11/29) and favourable conclusions, RR=0.75 (95% CI 0.29 to 1.95; n=43). Studies with industry sponsorship, (HR=0.78; n=3 studies) showed a decreased magnitude of risk of CVD outcomes compared with studies with no industry sponsorship (HR=0.97; n=18) (ratio of HRs 0.80 (95% CI 0.66 to 0.97); p=0.03). STRENGTHS AND LIMITATIONS OF EVIDENCE: Every study had an overall high risk of bias rating; this was primarily due to confounding. INTERPRETATION: There was no clear evidence of an association between studies with food industry ties and the reporting of favourable results and conclusions compared with studies without industry ties. The statistically significant difference in the magnitude of effects identified in industry-sponsored studies compared with non-industry-sponsored studies, however, is important in quantifying industry influence on studies included in dietary guidelines. PROSPERO REGISTRATION NUMBER: CRD42019129659.

Policies affecting the supply and access of opioid analgesics: a scoping review protocol.

OBJECTIVE: This scoping review aims to describe and map the range of evaluated policies that affect the supply and access of opioids for analgesic therapy. INTRODUCTION: There has been increasing concern regarding the rise in opioid analgesic misuse and related harms, including overdose deaths. In response, policies have been developed and implemented to reduce the burden of opioid-related problems, including strategies that aim to affect the supply and/or access of opioid analgesics. However, little is known about the range and nature of these policies, including whether they have been evaluated for effectiveness and how. INCLUSION CRITERIA: Studies to be included must evaluate the effectiveness of policies directly designed to affect the supply and/or access of opioids for analgesic therapy, and measure clinical and health services outcomes quantitatively. Studies that assessed interventions or factors impacting the use of these policies, measured only utilization of the policy itself, and/or measured outcomes regarding attitudes and behaviors towards these policies will be excluded. Literature on policies for the treatment and management of opioid abuse, overdose, or addiction will be excluded. METHODS: Multiple databases will be searched including MEDLINE, Embase, PsycINFO, Scopus, and Web of Science using keywords, indexed terms, and phrases for the following concepts: opioid, policy, evaluation, and clinical context. Each included study will be rated using a modified version of the JBI Levels of Evidence framework. Details on included policies and their assessment will be extracted, and results presented in diagrams and tables.

Methodological quality of public health guideline recommendations on vitamin D and calcium : a systematic review protocol.

INTRODUCTION: Current recommendations for vitamin D and calcium in dietary guidelines and bone health guidelines vary significantly among countries and professional organisations. It is unknown whether the methods used to develop these recommendations followed a rigourous process and how the differences in methods used may affect the recommended intakes of vitamin D and calcium. The objectives of this study are (1) collate and compare recommendations for vitamin D and calcium across guidelines, (2) appraise methodological quality of the guideline recommendations and (3) identify methodological factors that may affect the recommended intakes for vitamin D and calcium. This study will make a significant contribution to enhancing the methodological rigour in public health guidelines for vitamin D and calcium recommendations. METHODS AND ANALYSES: We will conduct a systematic review to evaluate vitamin D and calcium recommendations for osteoporosis prevention in generally healthy middle-aged and older adults. Methodological assessment will be performed for each guideline against those outlined in the 2014 WHO handbook for guideline development. A systematic search strategy will be applied to locate food-based dietary guidelines and bone health guidelines indexed in various electronic databases, guideline repositories and grey literature from 1 January 2009 to 28 February 2019. Descriptive statistics will be used to summarise the data on intake recommendation and on proportion of guidelines consistent with the WHO criteria. Logistic regression, if feasible, will be used to assess the relationships between the methodological factors and the recommendation intakes. ETHICS AND DISSEMINATION: Ethics approval is not required as we will only extract published data or information from the published guidelines. Results of this review will be disseminated through conference presentations and peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42019126452.

Association of industry ties with outcomes of studies examining the effect of wholegrain foods on cardiovascular disease and mortality: systematic review and meta-analysis.

OBJECTIVE: To determine if observational studies examining the association of wholegrain foods with cardiovascular disease (CVD) with food industry sponsorship and/or authors with conflicts of interest (COI) with the food industry are more likely to have results and/or conclusions that are favourable to industry than those with no industry ties, and to determine whether studies with industry ties differ in their risk of bias compared with studies with no industry ties. DESIGN: Systematic review and meta-analysis of observational studies. DATA SOURCES: We searched eight databases from 1997 to 2017 and hand searched the reference lists of included studies. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Cohort and case-control studies that quantitatively examined the association of wholegrains or wholegrain foods with CVD outcomes in healthy adults or children. RESULTS: 21 of the 22 studies had a serious or critical risk of bias. Studies with industry ties more often had favourable results compared with those with no industry ties, but the Confidence Interval (CI) was wide, Risk Ratio (RR)=1.44 (95% CI 0.88 to 2.35). The same association was found for study conclusions. We did not find a difference in effect size (magnitude of RRs) between studies with industry ties, RR=0.77 (95% CI 0.58 to 1.01) and studies with no industry ties, RR=0.85 (95% CI 0.73 to 1.00) (p=0.50) I2 0%. These results were comparable for studies that measured the magnitude using Hazard Ratios (HR); industry ties HR=0.82 (95% CI 0.76 to 0.88) versus no industry ties HR=0.86 (95% CI 0.81 to 0.91) (p=0.34) I2 0%. CONCLUSIONS: We did not establish that the presence of food industry sponsorship or authors with a COI with the food industry was associated with results or conclusions that favour industry sponsors. The association of food industry sponsorship or authors with a COI with the food industry and favourable results or conclusions is uncertain. However, our analysis was hindered by the low level of COI disclosure in the included studies. Our findings support international reforms to improve the disclosure and management of COI in nutrition research. Without such disclosures, it will not be possible to determine if the results of nutrition research are free of food industry influences and potential biases. PROSPERO REGISTRATION NUMBER: CRD42017055841.

Medical donations are not always free: an assessment of compliance of medicine and medical device donations with World Health Organization guidelines (2009-2017).

Medicine and medical device donations have the potential to improve access to healthcare in some of the poorest parts of the world, but can do more harm than good. World Health Organization guidelines advise donors on how to make effective and useful donations. Our objective was to assess compliance of recent medicine or medical device donations with WHO guidelines from 2009 onwards. We searched media, academic and gray literature, including industry and organizational documents, to identify reports describing specific incidences of the donation of medicines or devices. We collected data on donation characteristics and guideline compliance. We identified 88 reports describing 53 donations. Most did not comply with at least some items in WHO guidelines and no reports provided sufficient information to assess compliance against all items. Donations that fail to comply with guidelines may be excessive, expired and/or burden recipient countries with storage and disposal costs. It was estimated that 40-70% of donated medical devices are not used as they are not functional, appropriate, or staff lack training. More effective donations involved needs assessments, training and the use of existing distribution networks. The donation of medicines and medical devices is frequently inadequately reported and at times inappropriate. Guidelines need to be enforced to ensure effective donations.

A Behavioral Physical Activity Intervention to Manage Moderate and Severe Fatigue Among Head and Neck Cancer Patients-Pre-efficacy Study in the National Institutes of Health ORBIT Model.

BACKGROUND: Cancer-related fatigue (CRF) reduces head and neck cancer (HNC) survival rates and is the most common, severe, and distressing symptom negatively impacting activities of daily living (ADLs) dependence among HNC patients. These patients remain physically inactive after their cancer treatment, although there is consensus that physical activity mitigates CRF in cancer patients. OBJECTIVE: A home-based personalized behavioral physical activity intervention with fitness graded motion exergames (PAfitME) was evaluated for its intervention components, intervention delivery mode, and intervention contact time/duration with initial assessment of the feasibility, acceptability, safety, and outcomes. METHODS: This study (N = 8) was a single-group, pre-post design to evaluate a 6-week PAfitME at the end of HNC treatment. Health outcomes were CRF, ADL dependence, and fitness performance. Behavioral outcomes were exergame adherence. RESULTS: Positive health and behavioral outcomes support the PAfitME protocol including intervention components, intervention delivery mode, and intervention contact times/duration. The PAfitME intervention is feasible and acceptable with promising adherence rates. No adverse events were reported. There was marked improvement in CRF, ADL dependence, cardiorespiratory fitness, balance, muscle strength, and shoulder forward flexion, with large to moderate effect sizes as a result of the PAfitME intervention. CONCLUSION: The PAfitME protocol is ready for additional testing in a randomized clinical trial. IMPLICATIONS FOR PRACTICE: The PAfitME intervention is a nurse-led nonpharmacological intervention. It can be integrated into home care or telehealth care for HNC patients at the end of their cancer treatment once effectiveness is established.

Investigation of Risk Of Bias due to Unreported and SelecTively included results in meta-analyses of nutrition research: the ROBUST study protocol.

Background: Dietary guidelines should be informed by systematic reviews (SRs) of the available scientific evidence. However, if the SRs that underpin dietary guidelines are flawed in their design, conduct or reporting, the recommendations contained therein may be misleading or harmful. To date there has been little empirical investigation of bias due to selective inclusion of results, and bias due to missing results, in SRs of food/diet-outcome relationships. Objectives: To explore in SRs with meta-analyses of the association between food/diet and health-related outcomes: (i) whether systematic reviewers selectively included study effect estimates in meta-analyses when multiple effect estimates were available; (ii) what impact selective inclusion of study effect estimates may have on meta-analytic effects, and; (iii) the risk of bias due to missing results (publication bias and selective non-reporting bias) in meta-analyses. Methods: We will systematically search for SRs with meta-analysis of the association between food/diet and health-related outcomes in a generally healthy population, published between January 2018 and June 2019. We will randomly sort titles and abstracts and screen them until we identify 50 eligible SRs. The first reported meta-analysis of a binary or continuous outcome in each SR (the 'index meta-analysis') will be evaluated. We will extract from study reports all study effect estimates that were eligible for inclusion in the index meta-analyses (e.g. from multiple instruments and time points) and will quantify and test for evidence of selective inclusion of results. We will also assess the risk of bias due to missing results in the index meta-analyses using a new tool (ROB-ME). Ethics and dissemination: Ethics approval is not required because information will only be extracted from published studies. Dissemination of the results will be through peer-reviewed publications and presentations at conferences. We will make all data collected from this study publicly available via the Open Science Framework.

The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures.

BACKGROUND: Systematic reviews, which assess the risk of bias in included studies, are increasingly used to develop environmental hazard assessments and public health guidelines. These research areas typically rely on evidence from human observational studies of exposures, yet there are currently no universally accepted standards for assessing risk of bias in such studies. The risk of bias in non-randomised studies of exposures (ROBINS-E) tool has been developed by building upon tools for risk of bias assessment of randomised trials, diagnostic test accuracy studies and observational studies of interventions. This paper reports our experience with the application of the ROBINS-E tool. METHODS: We applied ROBINS-E to 74 exposure studies (60 cohort studies, 14 case-control studies) in 3 areas: environmental risk, dietary exposure and drug harm. All investigators provided written feedback, and we documented verbal discussion of the tool. We inductively and iteratively classified the feedback into 7 themes based on commonalities and differences until all the feedback was accounted for in the themes. We present a description of each theme. RESULTS: We identified practical concerns with the premise that ROBINS-E is a structured comparison of the observational study being rated to the 'ideal' randomised controlled trial. ROBINS-E assesses 7 domains of bias, but relevant questions related to some critical sources of bias, such as exposure and funding source, are not assessed. ROBINS-E fails to discriminate between studies with a single risk of bias or multiple risks of bias. ROBINS-E is severely limited at determining whether confounders will bias study outcomes. The construct of co-exposures was difficult to distinguish from confounders. Applying ROBINS-E was time-consuming and confusing. CONCLUSIONS: Our experience suggests that the ROBINS-E tool does not meet the need for an international standard for evaluating human observational studies for questions of harm relevant to public and environmental health. We propose that a simpler tool, based on empirical evidence of bias, would provide accurate measures of risk of bias and is more likely to meet the needs of the environmental and public health community.

Exergame Grading Scheme: Concept Development and Preliminary Psychometric Evaluations in Cancer Survivors.

The challenge of using exergames to promote physical activity among cancer survivors lies in the selection of the exergames that match their fitness level. There is a need for a standardized grading scheme by which to judge an exergame's capacity to address specific physical fitness attributes with different levels of physical engagement. The study aimed to develop an Exergame Grading Scheme and preliminarily evaluate its psychometric properties. Fourteen (14) items were created from the human movement and exergame literature. The content validity index (CVI) was rated by content experts with two consecutive rounds (N = 5 and N = 3 independently). The interrater reliability (IRR) was determined by two raters who used the Exergame Grading Scheme to determine the grading score of the five exergames performed by two cancer survivors (N = 10). Each item had a score of 1 for item-level CVI and 1 for k. For IRR, 9 items had rho values of 1, 1 item had 0.93, and 4 items had between 0.80 and 0.89. This valid and reliable Exergame Grading Scheme makes it possible to develop a personalized physical activity program using any type of exergame or fitness mobile application in rehabilitation practice to meet the needs of cancer survivors.

Families as Partners in Hospital Error and Adverse Event Surveillance.

Importance: Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. Objective: To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. Design, Setting, and Participants: We conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; κ, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. Main Outcomes and Measures: Error and AE rates. Results: Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P = .006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates. Conclusions and Relevance: Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety.

The beliefs of nurses who were involved in a whistleblowing event.

BACKGROUND: Nursing codes of ethics bind nurses to the role of patient advocate and compel them to take action when the rights or safety of a patient are jeopardized. Reporting misconduct is known as whistleblowing and studies indicate that there are personal and professional risks involved in blowing the whistle. AIM: The aim of this study was to explore the beliefs of nurses who wrestled with this ethical dilemma. DESIGN: A descriptive survey design was used to examine the beliefs of nurses in Western Australia who reported misconduct (whistleblowers) and of those who did not report misconduct (nonwhistleblowers). METHODS: The instrument listed statements from current ethical codes, statements from traditional views on nursing and statements of beliefs related to the participant's whistleblowing experience. Respondents were asked to rate each item on a five-point Likert format which ranged from strongly agree to strongly disagree. Data were analysed using a Pearson's correlation matrix and one-way ANOVA. To further explore the data, a factor analysis was run with varimax rotation. RESULTS: Results indicated that whistleblowers supported the beliefs inherent in patient advocacy, while nonwhistleblowers retained a belief in the traditional role of nursing. Participants who reported misconduct (whistleblowers) supported the belief that nurses were primarily responsible to the patient and should protect a patient from incompetent or unethical people. Participants who did not report misconduct (nonwhistleblowers) supported the belief that nurses are obligated to follow a physician's order at all times and that nurses are equally responsible to the patient, the physician and the employer. CONCLUSION: These findings indicate that nurses may respond to ethical dilemmas based on different belief systems.

Physical and emotional effects of whistleblowing.

This research examined the stress-induced health effects of whistleblowing and non-whistleblowing on nurses in Western Australia. A descriptive survey design was used to explore the physical and emotional problems experienced by nurses who did and did not blow the whistle on misconduct in the workplace. A questionnaire based on Lazarus and Folkman's Model of Stress and Coping was developed and posted anonymously to general and mental health nurses. Ninety-five nurses responded to the questionnaire, and 70 were identified as whistleblowers and 25 were identified as non-whistleblowers. Results indicated that 70% of whistleblowers and 64% of non-whistleblowers experienced stress-induced physical problems from being involved in a whistleblowing situation. The most common physical problems experienced by nurses were restless sleep, fatigue, headaches, insomnia, and increased smoking. In addition, 94% of whistleblowers and 92% of non-whistleblowers suffered stress-related emotional problems, the most frequent being anger, anxiety, and disillusionment. Whistleblowers and non-whistleblowers suffered a similar percentage of physical health problems, whereas non-whistleblowers suffered a higher percentage of emotional health problems, especially feelings of guilt, shame, and unworthiness. These findings suggest that whistleblowing situations are stressful and may cause physical and emotional health problems whether one blows the whistle or not.