Episodic disability questionnaire (EDQ) measurement properties among adults living with HIV in Canada, Ireland, United Kingdom, and United States.

BACKGROUND: The Episodic Disability Questionnaire (EDQ) is a generic 35-item patient-reported outcome measure of presence, severity and episodic nature of disability. We assessed the measurement properties of the Episodic Disability Questionnaire (EDQ) with adults living with HIV. METHODS: We conducted a measurement study with adults living with HIV in eight clinical settings in Canada, Ireland, United Kingdom, and United States. We electronically administered the EDQ followed by three reference measures (World Health Organization Disability Assessment Schedule; Patient Health Questionnaire; Social Support Scale) and a demographic questionnaire. We administered the EDQ only 1 week later. We assessed the internal consistency reliability (Cronbach's alpha; > 0.7 acceptable), and test-retest reliability (Intra Class Correlation Coefficient; > 0.7 acceptable). We estimated required change in EDQ domain scores to be 95% certain that a change was not due to measurement error (Minimum Detectable Change (MDC95%)). We evaluated construct validity by assessing 36 primary hypotheses of relationships between EDQ scores and scores on the reference measures (> 75% hypotheses confirmed indicated validity). RESULTS: Three hundred fifty nine participants completed the questionnaires at time point 1, of which 321 (89%) completed the EDQ approximately 1 week later. Cronbach's alpha for internal consistency ranged from 0.84 (social domain) to 0.91 (day domain) for the EDQ severity scale, and 0.72 (uncertainty domain) to 0.88 (day domain) for the EDQ presence scale, and 0.87 (physical, cognitive, mental-emotional domains) to 0.89 (uncertainty domain) for the EDQ episodic scale. ICCs for test-retest reliability ranged from 0.79 (physical domain) to 0.88 (day domain) for the EDQ severity scale and from 0.71 (uncertainty domain) to 0.85 (day domain) for the EDQ presence scale. Highest precision was demonstrated in the severity scale for each domain (MDC95% range: 19-25 out of 100), followed by the presence (MDC95% range: 37-54) and episodic scales (MDC95% range:44-76). Twenty-nine of 36 (81%) construct validity hypotheses were confirmed. CONCLUSIONS: The EDQ possesses internal consistency reliability, construct validity, and test-retest reliability, with limited precision when administered electronically with adults living with HIV across in clinical settings in four countries. Given the measurement properties, the EDQ can be used for group level comparisons for research and program evaluation in adults living with HIV.

Disability and self-care living strategies among adults living with HIV during the COVID-19 pandemic.

BACKGROUND: Events associated with the COVID-19 pandemic, such as physical distancing, closure of community services, postponement of health appointments, and loss of employment can lead to social isolation, financial uncertainty, and interruption of antiretroviral adherence, resulting in additional health-related challenges (disability) experienced among adults living with chronic illness such as HIV. 'Living strategies' is a concept derived from the perspectives of people living with HIV, defined as behaviors, attitudes and beliefs adopted by people living with HIV to help deal with disability associated with HIV and multi-morbidity. Our aim was to describe disability among adults living with HIV and self-care living strategies used during the COVID-19 pandemic. METHODS: Adults living with HIV in Toronto, Ontario, Canada, including some with pre-pandemic HIV Disability Questionnaire (HDQ) data, completed a cross-sectional web-based survey between June-August 2020. The survey included the HDQ and questions about self-care living strategy use during the pandemic. We compared disability (HDQ) scores prior to versus during the pandemic using paired t-tests. We reported the proportion of participants who engaged in various living strategies at least 'a few times a week' or 'everyday' during the pandemic. RESULTS: Of the 63 respondents, 84% were men, median age 57 years, and 62% lived alone. During the pandemic the greatest disability severity was in the uncertainty [median 30; Interquartile range (IQR): 16, 43] and mental-emotional (25; IQR: 14, 41) domains. Among the 51 participants with pre-pandemic data, HDQ severity scores were significantly greater (worse) during the pandemic (vs prior) in all domains. Greatest change from prior to during the pandemic was in the mental-emotional domain for presence (17.7; p < 0.001), severity (11.4; p < 0.001), and episodic nature (9.3; p < 0.05) of disability. Most participants (> 60%) reported engaging a 'few times a week' or 'everyday' in self-care strategies associated with maintaining sense of control and adopting positive attitudes and beliefs. CONCLUSIONS: People living with HIV reported high levels of uncertainty and mental-emotional health challenges during the pandemic. Disability increased across all HDQ dimensions, with the greatest worsening in the mental-emotional health domain. Results provide an understanding of disability and self-care strategy use during the COVID-19 pandemic.

Red and Processed Meat Consumption and Risk for All-Cause Mortality and Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Cohort Studies.

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: Dietary guidelines generally recommend limiting intake of red and processed meat. However, the quality of evidence implicating red and processed meat in adverse health outcomes remains unclear. Purpose: To evaluate the association between red and processed meat consumption and all-cause mortality, cardiometabolic outcomes, quality of life, and satisfaction with diet among adults. Data Sources: EMBASE (Elsevier), Cochrane Central Register of Controlled Trials (Wiley), Web of Science (Clarivate Analytics), CINAHL (EBSCO), and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019, without language restrictions, as well as bibliographies of relevant articles. Study Selection: Cohort studies with at least 1000 participants that reported an association between unprocessed red or processed meat intake and outcomes of interest. Data Extraction: Teams of 2 reviewers independently extracted data and assessed risk of bias. One investigator assessed certainty of evidence, and the senior investigator confirmed the assessments. Data Synthesis: Of 61 articles reporting on 55 cohorts with more than 4 million participants, none addressed quality of life or satisfaction with diet. Low-certainty evidence was found that a reduction in unprocessed red meat intake of 3 servings per week is associated with a very small reduction in risk for cardiovascular mortality, stroke, myocardial infarction (MI), and type 2 diabetes. Likewise, low-certainty evidence was found that a reduction in processed meat intake of 3 servings per week is associated with a very small decrease in risk for all-cause mortality, cardiovascular mortality, stroke, MI, and type 2 diabetes. Limitation: Inadequate adjustment for known confounders, residual confounding due to observational design, and recall bias associated with dietary measurement. Conclusion: The magnitude of association between red and processed meat consumption and all-cause mortality and adverse cardiometabolic outcomes is very small, and the evidence is of low certainty. Primary Funding Source: None. (PROSPERO: CRD42017074074).

Patterns of Red and Processed Meat Consumption and Risk for Cardiometabolic and Cancer Outcomes: A Systematic Review and Meta-analysis of Cohort Studies.

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: Studying dietary patterns may provide insights into the potential effects of red and processed meat on health outcomes. Purpose: To evaluate the effect of dietary patterns, including different amounts of red or processed meat, on all-cause mortality, cardiometabolic outcomes, and cancer incidence and mortality. Data Sources: Systematic search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, CINAHL, Web of Science, and ProQuest Dissertations & Theses Global from inception to April 2019 with no restrictions on year or language. Study Selection: Teams of 2 reviewers independently screened search results and included prospective cohort studies with 1000 or more participants that reported on the association between dietary patterns and health outcomes. Data Extraction: Two reviewers independently extracted data, assessed risk of bias, and evaluated the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. Data Synthesis: Eligible studies that followed patients for 2 to 34 years revealed low- to very-low-certainty evidence that dietary patterns lower in red and processed meat intake result in very small or possibly small decreases in all-cause mortality, cancer mortality and incidence, cardiovascular mortality, nonfatal coronary heart disease, fatal and nonfatal myocardial infarction, and type 2 diabetes. For all-cause, cancer, and cardiovascular mortality and incidence of some types of cancer, the total sample included more than 400 000 patients; for other outcomes, total samples included 4000 to more than 300 000 patients. Limitation: Observational studies are prone to residual confounding, and these studies provide low- or very-low-certainty evidence according to the GRADE criteria. Conclusion: Low- or very-low-certainty evidence suggests that dietary patterns with less red and processed meat intake may result in very small reductions in adverse cardiometabolic and cancer outcomes. Primary Funding Source: None. (PROSPERO: CRD42017074074).

Longitudinal trajectories and reference centiles for the impact of health conditions on daily activities of children with cerebral palsy.

AIM: First, to describe the impact of health conditions on daily activities over time in children with cerebral palsy (CP) and to create age-specific reference centiles. Second, to determine the amount of change typical over a 1-year period, across Gross Motor Function Classification System (GMFCS) levels. METHOD: A prospective, cohort design, with five assessments over 2 years, involved 708 children with a confirmed diagnosis of CP participating in the On Track Study (396 males, 312 females; mean age 6y [SD 2y 7mo]; range 18mo-12y at first assessment; 32.1% in GMFCS level I, 22.7% in GMFCS level II, 11.2% in GMFCS level III, 18.2% in GMFCS level IV, 15.7% in GMFCS level V). The impact of health conditions on daily activities was assessed using the Child Health Conditions Questionnaire. Data were analyzed using mixed-effects models and quantile regression. RESULTS: Linear longitudinal trajectories describe the relatively stable impact of health conditions over time for each functional level for children aged 2 years to 12 years, with the lowest scores (least impact) in GMFCS level I and the highest scores (highest impact) in GMFCS level V. Centiles were created for children in each GMFCS level. A system to interpret the magnitude of change over time in centiles was developed. INTERPRETATION: Longitudinal trajectories of co-occurring health conditions assist with understanding children's prognoses. Centiles assist in understanding a child's experience relative to children in similar GMFCS levels. Guidelines are provided to determine if children are progressing 'as expected', 'better than expected' or 'more poorly than expected' in regard to the impact of health conditions on daily activities. WHAT THIS PAPER ADDS: For children with cerebral palsy, the mean impact of health conditions on daily activities is relatively stable. Significant intraindividual and interindividual variability for the impact of health conditions exists, which complicates prognosis. Centiles enable interpretation of the impact of health conditions relative to Gross Motor Function Classification System level.

TRAYECTORIAS LONGITUDINALES Y CENTILES DE REFERENCIA PARA EL IMPACTO DE LAS CONDICIONES DE SALUD EN LAS ACTIVIDADES DIARIAS DE LOS NIÑOS CON PARÁLISIS CEREBRAL: OBJETIVO: Primero, describir el impacto de las condiciones de salud en las actividades diarias a lo largo del tiempo en niños con parálisis cerebral (PC) y crear centiles de referencia específicos de la edad. Segundo, para determinar la cantidad de cambio típica en un período de 1 año, a través de los niveles del Sistema de Clasificación de la Función Motora Bruta (GMFCS). MÉTODO: Un diseño de cohorte prospectivo, con cinco evaluaciones durante 2 años, involucró a 708 niños con un diagnóstico confirmado de PC que participó en el estudio On Track (396 varones, 312 mujeres; edad media 6 años de edad [SD 2 años 7 meses]; rango 18 meses-12 años a primera evaluación: 32,1% en GMFCS nivel I, 22,7% en GMFCS nivel II, 11,2% en GMFCS nivel III, 18,2% en GMFCS nivel IV, 15,7% en GMFCS nivel V). El impacto de las condiciones de salud en las actividades diarias se evaluó utilizando el Cuestionario de Condiciones de Salud Infantil. Los datos se analizaron utilizando modelos de efectos mixtos y regresión por cuantiles. RESULTADOS: Las trayectorias longitudinales lineales describen el impacto relativamente estable de las condiciones de salud a lo largo del tiempo para cada nivel funcional para niños de 2 años a 12 años, con las puntuaciones más bajas (menor impacto) en el nivel I de GMFCS y las puntuaciones más altas (mayor impacto) en el nivel de GMFCS V. Centiles fueron creados para los niños en cada nivel de GMFCS. Se desarrolló un sistema para interpretar la magnitud del cambio en el tiempo en centiles. INTERPRETACIÓN: Las trayectorias longitudinales de las condiciones de salud concurrentes ayudan a comprender los pronósticos de los niños. Los centiles ayudan a comprender la experiencia de un niño en relación con los niños en niveles similares de GMFCS. Se proporcionan pautas para determinar si los niños progresan "como se espera", "mejor de lo esperado" o "peor de lo esperado" en relación con el impacto de las condiciones de salud en las actividades diarias.

TRAJETÓRIAS LONGITUDINAIS E CENTIS DE REFERÊNCIA PARA O IMPACTO DAS CONDIÇÕES DE SAÚDE NAS ATIVIDADES DIÁRIAS DE CRIANÇAS COM PARALISIA CEREBRAL: OBJETIVO: Primeiro, descrever o impacto das condições de saúde nas atividades diárias ao longo do tempo em crianças com paralisia cerebral (PC) e criar centis de referência idade-específicos. Segundo, determinar a quantidade de mudança típica em um ano, nos diversos níveis do Sistema de Classificação da Função Motora Grossa (GMFCS). MÉTODO: Um desenho prospectivo de coorte, com cinco avaliações em 2 anos, envolveu 708 crianças com diagnóstico confirmado de PC que participavam do Estudo On Track (396 do sexo masculino, 312 do sexo feminino; méida de idade 6a [DP 2a 7m]; variação 18m-12a na primeira avaliação; 32,1% no nível GMFCS I, 22,7% no nível GMFCS II, 11,2% no nível GMFCS III, 18,2% no nível GMFCS IV, 15,7% no nível GMFCS V). O impacto das condições de saúde nas atividades diárias foi avaliado usando o Questionário das condições de saúde da criança. Os dados foram analisados usando modelos de efeitos mistos e regressão quantil. RESULTADOS: Trajetórias lineares longitudinais descrevem o impacto relativamente estável das condições de saúde ao longo do tempo para cada nível funcional para crianças com idades de 2 a 12 anos, com os menores escores (menor impacto) no nível GMFCS I e maiores escores (maior impacto) no nível GMFCS V. Centis foram criados para crianças em cada nível GMFCS. Um sistema para interpretar a magnitude da mudança ao longo do tempo em centis foi criado. INTERPRETAÇÃO: Trajetórias longitudinais de condições de saúde co-ocorrentes ajudam a entender o prognóstico da criança. Os centis ajudam a compreender a experiência da criança com relação a crianças em níveis GMFCS similares. Diretrizes são oferecidas para determinar se crianças estão progredindo "como esperado", "melhor do que o esperado"ou "pior do que o esperado" com relação ao impacto das condições de saúde nas atividades diárias.

A population-based study of communicative participation in preschool children with speech-language impairments.

AIM: To develop statistical models of communicative participation development of preschool children and explore variations by level of function. METHOD: This was a secondary analysis of data from a longitudinal study of preschool children with speech and language impairments (n=46 872; age range 18-67mo, mean age [SD] 41.76mo [11.92]; 67% male) accessing publicly funded services in Ontario, Canada. Two measures were used: Focus on the Outcomes of Communication Under Six (FOCUS), measuring changes in communicative participation skills, and the Communication Function Classification System (CFCS), classifying communicative function into one of five levels. We used mixed effects modeling to fit growth curves for children in each CFCS level. Models allowed for variation in initial FOCUS score at 18 months, rate of growth with age, and rate of acceleration/deceleration with age. RESULTS: Starting FOCUS score (18mo) varied inversely with CFCS level at entry to the program. Growth was initially rapid and then leveled off for children in Levels I to III. Growth was less rapid for children in Level IV, but leveled off, and was slow but continual for children in Level V. INTERPRETATION: This work can help us to move beyond traditional impairment-based thinking and shows that children can make meaningful communicative changes regardless of their function.

A process evaluation accompanying an attempted randomized controlled trial of an evidence service for health system policymakers.

BACKGROUND: We developed an evidence service that draws inputs from Health Systems Evidence (HSE), which is a comprehensive database of research evidence about governance, financial and delivery arrangements within health systems and about implementation strategies relevant to health systems. Our goal was to evaluate whether, how and why a 'full-serve' evidence service increases the use of synthesized research evidence by policy analysts and advisors in the Ontario Ministry of Health and Long-Term Care as compared to a 'self-serve' evidence service. METHODS: We attempted to conduct a two-arm, 10-month randomized controlled trial (RCT), along with a follow-up qualitative process evaluation, but we terminated the RCT when we failed to reach our recruitment target. For the qualitative process evaluation we modified the original interview guide to allow us to explore the (1) factors influencing participation in the trial; (2) usage of HSE, factors explaining usage patterns, and strategies to increase usage; (3) participation in training workshops and use of other supports; and (4) views about and experiences with key HSE features. RESULTS: We terminated the RCT given our 15% recruitment rate. Six factors were identified by those who had agreed to participate in the trial as encouraging their participation: relevance of the study to participants' own work; familiarity with the researchers; personal view of the importance of using research evidence in policymaking; academic background; support from supervisors; and participation of colleagues. Most reported that they never, infrequently or inconsistently used HSE and suggested strategies to increase its use, including regular email reminders and employee training. However, only two participants indicated that employee training, in the form of a workshop about finding and using research evidence, had influenced their use of HSE. Most participants found HSE features to be intuitive and helpful, although registration/sign-in and some page formats (particularly the advanced search page and detailed search results page) discouraged their use or did not optimize the user experience. CONCLUSIONS: The qualitative findings informed a re-design of HSE, which allows users to more efficiently find and use research evidence about how to strengthen or reform health systems or in how to get cost-effective programs, services and drugs to those who need them. Our experience with RCT recruitment suggests the need to consider changing the unit of allocation to divisions instead of individuals within divisions, among other lessons. TRIAL REGISTRATION: This protocol for this study is published in Implementation Science and registered with ClinicalTrials.gov ( HHS/FHS REB 10-267 ).

Quality-of-life after brain injury in childhood: time, not severity, is the significant factor.

OBJECTIVE: Little is known about the impact of acquired brain injury (ABI) on the long-term quality-of-life (QoL) in children and youth. The objectives of this study were to illustrate the long-term QoL trajectories at 5 years post-ABI. METHODS: The QoL of children between 5-18 years (n = 94) admitted to McMaster Children's Hospital with ABI were assessed longitudinally for a minimum of 5 years post-injury using the Child Health Questionnaire. Independent t-tests were used to examine differences in QoL between the study cohort and a normative sample at different time points. Mixed-effects models were used to identify predictors for QoL. RESULTS: The QoL of children with ABI was significantly poorer (p < 0.05) than the normative data on all domains and at all-time points except at baseline. The CHQ physical summary score (PHSS) showed a significant decline immediately after injury and a significant recovery at 8 months post-injury; while the CHQ psychosocial summary score (PSSS) showed a significant immediate decline, which remained over the course of the study. Pre-morbid school record, time post-injury and mechanism of injury significantly predicted the CHQ PSSS. CONCLUSIONS: QoL is impacted by ABI regardless of severity. This impact is further affected by time post-injury.

Longitudinal development of gross motor function among Dutch children and young adults with cerebral palsy: an investigation of motor growth curves.

AIM: The aim of this study was to describe patterns for gross motor development by level of severity in a Dutch population of individuals with cerebral palsy (CP). METHOD: This longitudinal study included 423 individuals (260 males, 163 females) with CP. The mean age at baseline was 9 years 6 months (SD 6y 2mo, range 1-22y). The level of severity of CP among participants, according to the Gross Motor Function Classification System (GMFCS), was 50% level I, 13% level II, 14% level III, 13% level IV, and 10% level V. Participants had been assessed up to four times with the Gross Motor Function Measure (GMFM-66) at 1- or 2-year intervals between 2002 and 2009. Data were analysed using non-linear mixed effects modelling. For each GMFCS level, patterns were created by contrasting a stable limit model (SLM) with a peak and decline model (PDM), followed by estimating limits and rates of gross motor development. RESULTS: The SLM showed a better fit for all GMFCS levels than the PDM. Within the SLM, significant differences between GMFCS levels were found for both the limits (higher values for lower GMFCS levels) and the rates (higher values for GMFCS levels I-II vs level IV and for GMFCS levels I-IV vs level V) of gross motor development. INTERPRETATION: The results validate the existence of five distinct patterns for gross motor development by level of severity of CP.

Episodic Disability Questionnaire (EDQ) measurement properties among adults living with HIV in Canada, Ireland, United Kingdom, and United States.

Background: The Episodic Disability Questionnaire (EDQ) is a generic 35-item patient-reported outcome measure of presence, severity and episodic nature of disability. We assessed the measurement properties of the Episodic Disability Questionnaire (EDQ) with adults living with HIV. Methods: We conducted a measurement study with adults living with HIV in eight clinical settings in Canada, Ireland, United Kingdom, and United States. We electronically administered the EDQ followed by three reference measures (World Health Organization Disability Assessment Schedule; Patient Health Questionnaire; Social Support Scale) and a demographic questionnaire. We administered the EDQ only 1 week later. We assessed the internal consistency reliability (Cronbach's alpha; >0.7 acceptable), and test-retest reliability (Intra Class Correlation Coefficient; >0.7 acceptable). We estimated required change in EDQ domain scores to be 95% certain that a change was not due to measurement error (Minimum Detectable Change (MDC95%)). We evaluated construct validity by assessing 36 primary hypotheses of relationships between EDQ scores and scores on the reference measures (> 75% hypotheses confirmed indicated validity). Results: 359 participants completed the questionnaires at time point 1, of which 321 (89%) completed the EDQ approximately 1 week later. Cronbach's alpha for internal consistency ranged from 0.84 (social domain) to 0.91 (day domain) for the EDQ severity scale, and 0.72 (uncertainty domain) to 0.88 (day domain) for the EDQ presence scale, and 0.87 (physical, cognitive, mental-emotional domains) to 0.89 (uncertainty domain) for the EDQ episodic scale. ICCs for test-retest reliability ranged from 0.79 (physical domain) to 0.88 (day domain) for the EDQ severity scale and from 0.71 (uncertainty domain) to 0.85 (day domain) for the EDQ presence scale. Highest precision was demonstrated in the severity scale for each domain (MDC95% range: 19-25 out of 100), followed by the presence (MDC95% range: 37-54) and episodic scales (MDC95% range:44-76). Twenty-nine of 36 (81%) construct validity hypotheses were confirmed. Conclusions: The EDQ possesses internal consistency reliability, construct validity, and test-retest reliability, with limited precision when administered electronically with adults living with HIV across in clinical settings in four countries. Given the measurement properties, the EDQ can be used for group level comparisons for research and program evaluation in adults living with HIV.

Assessing the sensibility and utility of a short-form version of the HIV Disability Questionnaire in clinical practice settings in Canada, Ireland and the USA: a mixed methods study.

OBJECTIVES: The Short-Form HIV Disability Questionnaire (SF-HDQ) was developed to measure the presence, severity and episodic nature of health challenges across six domains. Our aim was to assess the sensibility, utility and implementation of the SF-HDQ in clinical practice. DESIGN: Mixed methods study design involving semistructured interviews and questionnaire administration. PARTICIPANTS: We recruited adults living with HIV and HIV clinicians in Canada, Ireland and the USA. METHODS: We electronically administered the SF-HDQ followed by a Sensibility Questionnaire (face and content validity, ease of usage, format) and conducted semistructured interviews to explore the utility and implementation of the SF-HDQ in clinical practice. The threshold for sensibility was a median score of >5/7 (adults living with HIV) and>4/7 (HIV clinicians) for ≥80% of items. Qualitative interview data were analysed using directed content analysis. RESULTS: Median sensibility scores were >5 (adults living with HIV; n=29) and >4 (HIV clinicians; n=16) for 18/19 (95%) items. Interview data indicated that the SF-HDQ represents the health-related challenges of living with HIV and other concurrent health conditions; captures the daily episodic nature of HIV; and is easy to use. Clinical utility included measuring health challenges and change over time, guiding referral to specialists and services, setting goals, facilitating communication and fostering a multidisciplinary approach to care. Considerations for implementation included flexible, person-centred approaches to administration, and communicating scores based on personal preferences. CONCLUSIONS: The SF-HDQ possesses sensibility and utility for use in clinical settings with adults living with HIV and HIV clinicians in three countries.

Determinants of physical activity among people with spinal cord injury: a test of social cognitive theory.

BACKGROUND: Little theory-based research has focused on understanding and increasing physical activity among people with physical disabilities. Testing a social cognitive theory-based model of determinants is important for identifying variables to target in physical activity-enhancing interventions. PURPOSE: The aim of this study is to examine Social Cognitive Theory variables as predictors of physical activity among people living with spinal cord injury. METHODS: Structural equation modeling was used to test a model of Social Cognitive Theory predictors of physical activity (n=160). RESULTS: The model explained 39% of the variance in physical activity. Self-regulation was the only significant, direct predictor. Self-regulatory efficacy and outcome expectations had indirect effects, mediated by self-regulation. CONCLUSION: Social Cognitive Theory is useful for predicting physical activity in people with spinal cord injury. Self-regulation is the most potent Social Cognitive Theory predictor of physical activity in people with spinal cord injury. Self-regulation and its determinants should be targeted in physical activity-enhancing interventions.

Characteristics and quality of systematic reviews and meta-analyses of observational nutritional epidemiology: a cross-sectional study.

BACKGROUND: Dietary recommendations and policies should be guided by rigorous systematic reviews. Reviews that are of poor methodological quality may be ineffective or misleading. Most of the evidence in nutrition comes from nonrandomized studies of nutritional exposures (usually referred to as nutritional epidemiology studies), but to date methodological evaluations of the quality of systematic reviews of such studies have been sparse and inconsistent. OBJECTIVES: We aimed to investigate the quality of recently published systematic reviews and meta-analyses of nutritional epidemiology studies and to propose guidance addressing major limitations. METHODS: We searched MEDLINE (January 2018-August 2019), EMBASE (January 2018-August 2019), and the Cochrane Database of Systematic Reviews (January 2018-February 2019) for systematic reviews of nutritional epidemiology studies. We included a random sample of 150 reviews. RESULTS: Most reviews were published by authors from Asia (n = 49; 32.7%) or Europe (n = 43; 28.7%) and investigated foods or beverages (n = 60; 40.0%) and cancer morbidity and mortality (n = 54; 36%). Reviews often had important limitations: less than one-quarter (n = 30; 20.0%) reported preregistration of a protocol and almost one-third (n = 42; 28.0%) did not report a replicable search strategy. Suboptimal practices and errors in the synthesis of results were common: one-quarter of meta-analyses (n = 30; 26.1%) selected the meta-analytic model based on statistical indicators of heterogeneity and almost half of meta-analyses (n = 50; 43.5%) did not consider dose-response associations even when it was appropriate to do so. Only 16 (10.7%) reviews used an established system to evaluate the certainty of evidence. CONCLUSIONS: Systematic reviews of nutritional epidemiology studies often have serious limitations. Authors can improve future reviews by involving statisticians, methodologists, and researchers with substantive knowledge in the specific area of nutrition being studied and using a rigorous and transparent system to evaluate the certainty of evidence.

Development of the AGREE II, part 2: assessment of validity of items and tools to support application.

BACKGROUND: We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user's manual in the beta version of the AGREE II. METHODS: We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user's manual and completed a survey assessing the manual. RESULTS: In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the beta-AGREE II could be improved. INTERPRETATION: The validity of the items was established and the user's manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user's manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation.

Development of the AGREE II, part 1: performance, usefulness and areas for improvement.

BACKGROUND: We undertook research to improve the AGREE instrument, a tool used to evaluate guidelines. We tested a new seven-point scale, evaluated the usefulness of the original items in the instrument, investigated evidence to support shorter, tailored versions of the tool, and identified areas for improvement. METHOD: We report on one component of a larger study that used a mixed design with four factors (user type, clinical topic, guideline and condition). For the analysis reported in this article, we asked participants to read a guideline and use the AGREE items to evaluate it based on a seven-point scale, to complete three outcome measures related to adoption of the guideline, and to provide feedback on the instrument's usefulness and how to improve it. RESULTS: Guideline developers gave lower-quality ratings than did clinicians or policy-makers. Five of six domains were significant predictors of participants' outcome measures (p < 0.05). All domains and items were rated as useful by stakeholders (mean scores > 4.0) with no significant differences by user type (p > 0.05). Internal consistency ranged between 0.64 and 0.89. Inter-rater reliability was satisfactory. We received feedback on how to improve the instrument. INTERPRETATION: Quality ratings of the AGREE domains were significant predictors of outcome measures associated with guideline adoption: guideline endorsements, overall intentions to use guidelines, and overall quality of guidelines. All AGREE items were assessed as useful in determining whether a participant would use a guideline. No clusters of items were found more useful by some users than others. The measurement properties of the seven-point scale were promising. These data contributed to the refinements and release of the AGREE II.

Probability of walking, wheeled mobility, and assisted mobility in children and adolescents with cerebral palsy.

AIM: Our aim was to describe how the probability of walking, wheeled mobility, and assisted mobility changes with environmental setting and age in children and adolescents with cerebral palsy (CP). METHOD: The parents of a population-based sample of 642 children and adolescents (360 males, 282 females; age range 16mo-21y) reported their children's mobility at home, school, and outdoors at 6- or 12-month intervals a mean of 5.2 times. Generalized mixed-effects analyses were used to model the probabilities. RESULTS: By age 3 years, children with motor function classified as level I according to the Gross Motor Function Classification System (GMFCS) walked in all three settings. Children/adolescents classified as level V used assisted mobility, with a small number using wheeled mobility. In the case of children classified as GMFCS level II, the probability of walking varied with the environmental setting, which, at age 18, is outdoors 90% of the time. Among children classified as GMFCS level III, the probability of walking was highest at age 9 at school (68%), and at age 18 was approximately 50% in all three settings. Among children/adolescents rated as GMFCS level IV, the probability of wheeled mobility increased with age and, at age 18, 57% of mobility took place outdoors. INTERPRETATION: The results provide evidence that age and environmental setting influence method of mobility of children/adolescents with CP. The method that is preferred in one setting may not be preferred in another setting or at another age.

Correlates of decline in gross motor capacity in adolescents with cerebral palsy in Gross Motor Function Classification System levels III to V: an exploratory study.

AIM: To explore associations between clinical variables and decline in motor capacity in adolescents with cerebral palsy (CP). METHOD: Participants included 76 males and 59 females, whose mean age at the beginning of the study was 14 years 6 months (SD 2.4, range 11.6-17.9); 51 at Gross Motor Function Classification System (GMFCS) level III, 47 at level IV, and 37 at level V. Ninety-six participants had tetraplegia, 32 had diplegia, and one had hemiplegia. Types of motor disorder were spastic n=98; mixed, n=11; dystonic, n=9; hypotonic, n=7; and ataxic n=3 (seven participants were not classified). Reliable raters collected data annually for 4 years on anthropometric characteristics, the Spinal Alignment and Range of Motion Measure, as well as the Gross Motor Function Measure, 66 items (GMFM-66); participants or their parents reported on health status (using the Health Utilities Questionnaire), pain, and exercise participation (using measures developed for this study). The predicted drop in GMFM-66 scores after childhood was calculated using data on the same children from an earlier study. Correlations were calculated between the drop in GMFM-66 scores and the average and change scores of the clinical variables (the alpha level for statistical significance of this exploratory study was 0.10). RESULTS: The drop in GMFM-66 score was significantly correlated with limitations in range of motion (r=0.42) and spinal alignment (r=0.28), and pain (r=0.16). Increases in triceps skinfold (r=-0.19), mid-arm circumference (r=-0.23), and the ratio of mid-arm circumference to knee height (r=-0.23) were associated with less decline. INTERPRETATION: Preventing range-of-motion limitations and pain experiences and optimizing nutrition might contribute to less decline in the gross motor capacity of adolescents with CP. Further investigation is required to clarify the role other factors that contribute to maintained function over time.

Development and validation of item sets to improve efficiency of administration of the 66-item Gross Motor Function Measure in children with cerebral palsy.

AIM: To develop an algorithmic approach to identify item sets of the 66-item version of the Gross Motor Function Measure (GMFM-66) to be administered to individual children, and to examine the validity of the algorithm for obtaining a GMFM-66 score. METHOD: An algorithmic approach was used to identify item sets of the GMFM-66 (GMFM-66-IS) using data from 95 males and 79 females with cerebral palsy (CP; mean age 14y 7mo, SD 1y 8mo, range 12y 7mo to 17y 8mo). The GMFM-66-IS scores were then validated using combined data from three Dutch studies involving 134 males and 92 females with CP (mean age 7y, SD 4y 6mo, range 1y 4mo to 13y 8mo), representing all levels of the Gross Motor Function Classification System. RESULTS: The final algorithm contains three decision items from the GMFM-66 that determine which one of four item sets to administer. The GMFM-66-IS has excellent agreement with the full GMFM-66 both at a single assessment (intraclass correlation coefficient [ICC]=0.994, 95% confidence intervals [CI] 0.993-0.996) and across repeat assessments (ICC=0.92, 95% CI 0.89-0.95). INTERPRETATION: The GMFM-66-IS is a promising alternative to the full GMFM-66. Users should be consistent in their choice of measure (GMFM-66 or GMFM-66-IS) on repeat testing and clearly identify which method was used.

Longitudinal trajectories of physical activity and walking performance by gross motor function classification system level for children with cerebral palsy.

Purpose: This study aims to present developmental trajectories for physical activity (PA) and walking performance for children with cerebral palsy (CP).Materials and methods: Seventy-nine children with CP, 39 (49%) female, Gross Motor Functional Classification System levels I-V, and mean age 91.3 months (+/-27.7 SD) participated. Participants in levels I-V wore the Actigraph to capture PA and children in levels I-II also wore a StepWatch (SW) (n = 43) to measure walking performance. Trajectories for average PA counts/minute and number of minutes of moderate to vigorous PA were generated for levels I, II, and III/IV/V (aggregate). Single leg strides/day and average strides faster than 30 strides/min trajectories were generated for levels I-II.Results: Participants did not display plateaus in PA or walking performance based on functional level. Children in all levels showed a decrease in amount and intensity of PA from 3.0 to 12 years old, with participants in level I demonstrating the steepest decline. Children in level I decreased slightly, and level II increased slightly in both walking performance measures from 3.0 to 12 years old.Conclusions: Longitudinal curves demonstrate variations in PA and walking performance by functional level and provide prognostic information as to what changes may be anticipated for children with CP.Implications for rehabilitationLongitudinal developmental trajectories for physical activity and walking performance for children with cerebral palsy across functional levels are documented.Trajectories have potential to support collaborative intervention planning between therapists and families relative to physical activity and walking performance.