The fallacy of enrolling only high-risk subjects in cancer prevention trials: Is there a "free lunch"?

BACKGROUND: There is a common belief that most cancer prevention trials should be restricted to high-risk subjects in order to increase statistical power. This strategy is appropriate if the ultimate target population is subjects at the same high-risk. However if the target population is the general population, three assumptions may underlie the decision to enroll high-risk subject instead of average-risk subjects from the general population: higher statistical power for the same sample size, lower costs for the same power and type I error, and a correct ratio of benefits to harms. We critically investigate the plausibility of these assumptions. METHODS: We considered each assumption in the context of a simple example. We investigated statistical power for fixed sample size when the investigators assume that relative risk is invariant over risk group, but when, in reality, risk difference is invariant over risk groups. We investigated possible costs when a trial of high-risk subjects has the same power and type I error as a larger trial of average-risk subjects from the general population. We investigated the ratios of benefit to harms when extrapolating from high-risk to average-risk subjects. RESULTS: Appearances here are misleading. First, the increase in statistical power with a trial of high-risk subjects rather than the same number of average-risk subjects from the general population assumes that the relative risk is the same for high-risk and average-risk subjects. However, if the absolute risk difference rather than the relative risk were the same, the power can be less with the high-risk subjects. In the analysis of data from a cancer prevention trial, we found that invariance of absolute risk difference over risk groups was nearly as plausible as invariance of relative risk over risk groups. Therefore a priori assumptions of constant relative risk across risk groups are not robust, limiting extrapolation of estimates of benefit to the general population. Second, a trial of high-risk subjects may cost more than a larger trial of average risk subjects with the same power and type I error because of additional recruitment and diagnostic testing to identify high-risk subjects. Third, the ratio of benefits to harms may be more favorable in high-risk persons than in average-risk persons in the general population, which means that extrapolating this ratio to the general population would be misleading. Thus there is no free lunch when using a trial of high-risk subjects to extrapolate results to the general population. CONCLUSION: Unless the intervention is targeted to only high-risk subjects, cancer prevention trials should be implemented in the general population

Suspected Motor Problems and Low Preference for Active Play in Childhood Are Associated with Physical Inactivity and Low Fitness in Adolescence

Background - This prospective longitudinal study investigates whether suspected motor problems and low preference for active play in childhood are associated with physical inactivity and low cardiorespiratory fitness in adolescence. Methodology/Principal Findings - The study sample consisted of the Northern Finland Birth Cohort 1986 (NFBC 1986) composed of 5,767 children whose parents responded to a postal inquiry concerning their children's motor skills at age 8 years and who themselves reported their physical activity at age 16 years. Cardiorespiratory fitness was measured with a cycle ergometer test at age 16 years. Odds ratios (OR) and their 95% confidence intervals (95% CI) for the level of physical activity and fitness were obtained from multinomial logistic regression and adjusted for socio-economic position and body mass index. Low preference for active play in childhood was associated with physical inactivity (boys: OR 3.31, 95% CI 2.42–4.53; girls: OR 1.79, 95% CI 1.36–2.36) and low cardiorespiratory fitness (boys: OR 1.87, 95% CI 1.27–2.74; girls: OR 1.52, 95% CI 1.09–2.11) in adolescence. Suspected gross (OR 2.16, 95% CI 1.33–3.49) and fine (OR 1.88, 95% CI 1.35–2.60) motor problems were associated with physical inactivity among boys. Children with suspected motor problems and low preference for active play tended to have an even higher risk of physical inactivity in adolescence. Conclusions/Significance - Low preference for active play in childhood was associated with physical inactivity and low cardiorespiratory fitness in adolescence. Furthermore, children with suspected motor problems and low preference for active play tended to have an even higher risk of physical inactivity in adolescence. Identification of children who do not prefer active play and who have motor problems may allow targeted interventions to support their motor learning and participation in active play and thereby promote their physical activity and fitness in later life.peerReviewe

Effectiveness of a 16 week gymnastics curriculum at developing movement competence in children.

OBJECTIVES: Internationally, children's movement competence levels are low. This study's aim was to evaluate the effectiveness of a 16 week gymnastics curriculum on stability, locomotive and object control skills and general body coordination. It was hypothesised that the gymnastics intervention group would demonstrate significant improvements beyond a PE comparison group. DESIGN: This study used a non-randomised control design. The intervention and comparison groups were drawn from three primary schools. The study followed the transparent reporting of evaluations with nonrandomized designs (TREND) statement for reporting. METHODS: A total of 333 children (51% girls, 41% intervention) with a mean age of 8.1 years (SD=1.1) participated. Intervention children (16 weeks×2h of gymnastics) were compared to children who received (16×2h) standard PE curriculum. Children's movement competence was assessed using the Test of Gross Motor Development-2, Stability Skills Assessment and the Körper-Koordinationstest für Kinder. Multilevel linear mixed models, accounting for variation at the class level and adjusted for age and sex, were used to assess intervention relative to comparison differences in all aspects of movement competence. RESULTS: Stability and object control skills showed a significant (p<0.05) intervention×time interaction effect. No difference was found in locomotor skills or general coordination. CONCLUSIONS: Gymnastics is effective at developing stability skills and object control skills without hindering the development of locomotor skills or general coordination. Accelerated learning of stability skills may support the development of more complex movement skills

“Children are precious cargo; we don’t let them take any risks!”: Hearing from adults on safety and risk in children’s active play in schools: a systematic review

Background: Understanding determinants of children’s outdoor play is important for improving low physical activity levels, and schools are a key setting for both. Safety concerns shape children’s opportunity to play actively outdoors, therefore, this qualitative evidence synthesis aimed to i) examine adult (e.g., parent, teacher, yard supervisor, principal) perspectives on safety and risk in children’s active play during recess in elementary and/or middle schools, and ii) identify how safety and risk influence playground supervision and decision making in this setting. Methods: Six electronic databases were systematically searched in March 2021, with an updated search in June 2022. Records were screened against eligibility criteria using Covidence software, and data extraction and synthesis were performed using predesigned coding forms in Microsoft Excel and NVivo. Framework synthesis methodology was employed, guided by a conceptual framework structured on the socio-ecological model (SEM) and affordance theory. Results: From 10,370 records, 25 studies were included that represented 608 adults across 89 schools from nine countries. The synthesis identified 10 constraining and four affording factors that influenced whether school staff were risk-averse or risk tolerant during recess, and, in turn, the degree to which children’s play was managed. Constraining factors stemmed from fears for children’s physical safety, and fear of blame and liability in the event of playground injury, which shaped parent, school staff and institutional responses to risk. Interrelated factors across SEM levels combined to drive risk-averse decision making and constraining supervision. Emerging evidence suggests children’s active play in schools can be promoted by fostering a risk tolerant and play friendly culture in schools through play facilitation training (e.g., risk-reframing, conflict resolution) and engaging stakeholders in the development of school policies and rules that balance benefits of play against potential risks. Conclusions: Findings show several socio-cultural factors limited the ability of school staff to genuinely promote active play. Future work should seek to foster risk tolerance in schools, challenge the cultural norms that shape parent attitudes and institutional responses to risk in children’s play, and explore novel methods for overcoming policy barriers and fear of liability in schools

Exploring Australian teachers’ perceptions of physical literacy: a mixed-methods study

Background: Physical literacy (PL) has generated substantial international interest across sport, health and education sectors. Teachers play a crucial role in supporting children’s PL growth. Despite PL featuring in several physical education curricular texts, research into teacher understanding and perception of the concept is scarce. This study aimed to explore the understanding and perception of PL among Australian teachers of health and physical education (including generalists and specialists). Methods: Utilizing an explanatory sequential mixed-methods study design, the first phase involved an online survey of 174 Australian teachers. The survey, developed from relevant literature, aimed to elicit an understanding of teachers’ awareness, understanding, and perceptions of PL, and comprised a combination of open-ended, yes/no, Likert, and multiple-choice response options. The second phase involved semi-structured telephone interviews with nine survey participants, to build on survey responses. Interviews lasting on average 37 (range 28–58) minutes were digitally recorded and transcribed verbatim. For quantitative data, bivariate comparisons were made using chi-square tests to examine the relationships between teacher training (generalist versus specialist), age group, years of teaching experience, and teacher PL understanding. Interview data were analyzed using an inductive thematic approach to identify emergent theme clusters. Results: Respondents (n = 122, male 48.4%) were mostly specialist trained teachers, with 10–14 years of teaching experience. Quantitative findings revealed that while most teachers were aware of PL, many only partially understood the concept, often interpreting it as an understanding of bodily movements and/or the benefits of physical activity participation. There were no differences in PL understanding by teacher training, age group, or years of teaching experience. Two main themes, identified from qualitative interviews, which provided further explanation of teachers’ understanding and perception of PL were: (a) ‘physical literacy has been a bit of a buzzword’: perceptions of the PL concept and (b) ‘It's a concept that needs to be ingrained’: implementing PL in schools. Teachers acknowledged the potential importance and applicability of PL, however, expressed scepticism (e.g. buzzword) about the concept. Narrow understanding of the concept persisted during interviews. In terms of its implementation within schools, teachers highlighted the need for curriculum alignment, provision of resources and professional development opportunities, and policy changes. In recognizing these implementation strategies, teachers further noted potential barriers that could hinder PL implementation including time constraints, workload and busyness, and the lack of prioritization of physical education (PE) within schools. Conclusion: Study findings revealed the urgent need to clarify the concept of PL for teachers given their critical role in ensuring effective and successful translation of research into educational practice. Resources, professional dialogue, and continuing professional development opportunities can support teachers’ overall understanding and implementation of PL. This is important for potentially maximizing children’s PL development across the lifespan

Multimorbidity in bipolar disorder and under-treatment of cardiovascular disease: a cross sectional study

Background: Individuals with serious mental disorders experience poor physical health, especially increased rates of cardiometabolic morbidity and premature morbidity. Recent evidence suggests that individuals with schizophrenia have numerous comorbid physical conditions which may be under-recorded and under-treated but to date very few studies have explored this issue for bipolar disorder. Methods:We conducted a cross-sectional analysis of a dataset of 1,751,841 registered patients within 314 primary-care practices in Scotland, U.K. Bipolar disorder was identified using Read Codes recorded within electronic medical records. Data on 32 common chronic physical conditions were also assessed. Potential prescribing inequalities were evaluated by analyzing prescribing data for coronary heart disease (CHD) and hypertension. Results: Compared to controls, individuals with bipolar disorder were significantly less likely to have no recorded physical conditions (OR 0.59, 95% CI 0.54-0.63) and significantly more likely to have one physical condition (OR 1.27, 95% CI 1.16-1.39), two physical conditions (OR 1.45, 95% CI 1.30-1.62) and three or more physical conditions (OR 1.44, 95% CI 1.30-1.64). People with bipolar disorder also had higher rates of thyroid disorders, chronic kidney disease, chronic pain, chronic obstructive airways disease and diabetes but, surprisingly, lower recorded rates of hypertension and atrial fibrillation. People with bipolar disorder and comorbid CHD or hypertension were significantly more likely to be prescribed no antihypertensive or cholesterol-lowering medications compared to controls, and bipolar individuals with CHD or hypertension were significantly less likely to be on 2 or more antihypertensive agents. Conclusions: Individuals with bipolar disorder are similar to individuals with schizophrenia in having a wide range of comorbid and multiple physical health conditions. They are also less likely than controls to have a primary-care record of cardiovascular conditions such as hypertension and atrial fibrillation. Those with a recorded diagnosis of CHD or hypertension were less likely to be treated with cardiovascular medications and were treated less intensively. This study highlights the high physical healthcare needs of people with bipolar disorder, and provides evidence for a systematic under-recognition and under-treatment of cardiovascular disease in this group

A systematic review of tools designed for teacher proxy-report of children’s physical literacy or constituting elements

Background: Physical literacy (PL) in childhood is essential for a healthy active lifestyle, with teachers playing a critical role in guiding its development. Teachers can assist children to acquire the skills, confidence, and creativity required to perform diverse movements and physical activities. However, to detect and directly intervene on the aspects of children’s PL that are suboptimal, teachers require valid and reliable measures. This systematic review critically evaluates the psychometric properties of teacher proxy-report instruments for assessing one or more of the 30 elements within the four domains (physical, psychological, cognitive, social) of the Australian Physical Literacy Framework (APLF), in children aged 5–12 years. Secondary aims were to: examine alignment of each measure (and relevant items) with the APLF and provide recommendations for teachers in assessing PL. Methods: Seven electronic databases (Academic Search Complete, CINAHL Complete, Education Source, Global Health, MEDLINE Complete, PsycINFO, and SPORTDiscus) were systematically searched originally in October 2019, with an updated search in April 2021. Eligible studies were peer-reviewed English language publications that sampled a population of children with mean age between 5 and 12 years and focused on developing and evaluating at least one psychometric property of a teacher proxy-report instrument for assessing one or more of the 30 APLF elements. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance was followed for the conduct and reporting of this review. The methodological quality of included studies and quality of psychometric properties of identified tools were evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidance. Alignment of each measure (and relevant items) with the APLF domains and 30 elements was appraised. Results: Database searches generated 61,412 citations; reduced to 41 studies that evaluated the psychometric properties of 24 teacher proxy-report tools. Six tools were classified as single domain measures (i.e. assessing a single domain of the APLF), eleven as dual-domain measures, and seven as tri-domain measures. No single tool captured all four domains and 30 elements of the APLF. Tools contained items that aligned with all physical, psychological, and social elements; however, four cognitive elements were not addressed by any measure. No tool was assessed for all nine psychometric properties outlined by COSMIN. Included studies reported a median of 3 out of nine psychometric properties. Most reported psychometric properties were construct validity (n = 32; 78% of studies), structural validity (n = 26; 63% of studies), and internal consistency (n = 25; 61% of studies). There was underreporting of content validity, cross-cultural validity, measurement error, and responsiveness. Psychometric data across tools were mostly indeterminate for construct validity, structural validity, and internal consistency. Conclusions: There is limited evidence to fully support the use of a specific teacher proxy-report tool in practice. Further psychometric testing and detailed reporting of methodological aspects in future validity and reliability studies is needed. Tools have been designed to assess some elements of the framework. However, no comprehensive teacher proxy-report tool exists to assess all 30 elements of the APLF, demonstrating the need for a new tool. It is our recommendation that such tools be developed and psychometrically tested. Trial registration: This systematic review was registered in the PROSPERO international prospective register of systematic reviews, with registration number CRD42019130936

“Am I also going to die, doctor?” A systematic review of the impact of in-hospital patients witnessing a resuscitation of another patient

Background: There is a growing interest in the impact of family-witnessed resuscitation. However, evidence about the effect of hospitalised patients witnessing other patients' resuscitations is limited. Aim: The aim of this systematic review is to explore the existing evidence related to the impact on patients who witness resuscitation attempts on other patients in hospital settings. Methods: The databases BNI, CINAHL, EMBASE, MEDLINE and PsycINFO were searched with the terms 'patient', 'inpatient', 'resuscitation', 'CPR', 'cardiopulmonary resuscitation' and 'witness'. The search strategy excluded the terms 'out-of-hospital', 'family' and 'relative'. The inclusion criteria were: studies related to patients exposed to a resuscitation attempt performed on another patient; quantitative and qualitative design; and physiological or psychological outcome measures. No limitations of date, language or settings were applied. Results: Five of the 540 identified studies were included: two observational studies with control groups and three qualitative studies with interviews and focus groups. Articles were published between 1968 and 2006 and were mostly rated to have a low quality of evidence. Quantitative results of the observational studies showed an increased heart rate in the study group witnessing a resuscitation (p = 0.05), increased systolic blood pressure (p &lt; 0.01) and increased anxiety (p &lt; 0.01). The qualitative studies highlighted the coping strategies adopted by exposed patients in response to witnessing resuscitation, including denial and dissociation. Conclusions: Our findings suggest that patients may find witnessing resuscitation to be a stressful experience. However, the evidence is sparse and mainly of poor quality. Further research is needed in order to better understand the impacts of patients witnessing a resuscitation of another patient and to identify effective support systems. © European Society of Cardiology 2017