Cancer of Oesophagus or Gastricus - New Assessment of Technology of Endosonography (COGNATE): report of pragmatic randomised trial.

BACKGROUND: Endoscopic ultrasonography is recommended for staging gastro-oesophageal cancers, but has never been evaluated. OBJECTIVE: COGNATE (Cancer of Oesophagus or Gastricus - New Assessment of Technology of Endosonography) therefore aimed to evaluate whether adding 'endoscopic ultrasound' (EUS) to the usual staging algorithm changes treatment, improves (quality-adjusted) survival, and uses resources cost-effectively. DESIGN: Pragmatic parallel-group trial. Patients with gastro-oesophageal cancer received standard staging algorithms. Multidisciplinary teams chose provisional management plans from endoscopic mucosal resection, immediate surgery, surgery after chemotherapy, or chemotherapy and radiotherapy. We used dynamic randomisation to allocate consenting patients remotely by telephone in equal proportions between EUS and not. Thereafter we recorded changes in management plan, use of health-care resources, and three aspects of participant-reported quality of life: generic [measured by European Quality of Life - 5 Dimensions (EQ-5D)], cancer related [Functional Assessment of Cancer Therapy - General scale (FACT-G)] and condition-specific [FACT - Additional Concerns scale (FACT-AC)]. We followed participants regularly until death or the end of the trial - for between 1 and 4.5 years. We devised a quality assurance programme to maintain standards of endosonographic reporting. SETTING: Eight British hospitals, of which two - one Scottish teaching hospital and one English district general hospital - contributed 80% of participants; we combined the other six for analysis. PARTICIPANTS: Patients were eligible if they had a diagnosis of gastro-oesophageal cancer, had not started treatment, were free of metastatic disease, were fit for surgery (even if not planned) and had American Society of Anesthesiologists and World Health Organization grades of less than 3. INTERVENTIONS: Intervention group: standard staging algorithm plus EUS; control group: standard staging algorithm. MAIN OUTCOME MEASURES: Primary: quality-adjusted survival. Secondary: survival; health-related quality of life (EQ-5D, FACT-G and FACT-AC scales); changes in management plan; and complete resection rate. Although blinding participants was neither possible nor desirable, those responsible for analysis remained blind until the Trial Steering Committee had reviewed the definitive analysis. RESULTS: We randomised 223 patients, of whom 213 yielded enough data for primary analysis. EUS improved survival adjusted for generic quality of life with a hazard ratio of 0.705 [95% confidence interval (CI) 0.499 to 0.995], and crude survival with a hazard ratio of 0.706 (95% CI 0.501 to 0.996). The benefits of EUS were significantly greater for those with poor initial quality of life, but did not differ between centres. EUS reduced net use of health-care resources by £2860 (95% 'bootstrapped' CI from -£2200 to £8000). Combining benefits and savings shows that EUS is likely to be cost-effective, with 96% probability of achieving the National Institute for Health and Care Excellence criterion of costing of < £20,000 to gain a QALY. There were no serious adverse reactions attributable to EUS. EUS enhanced the management plan for many participants, increased the proportion of tumours completely resected from 80% (44 out of 55) to 91% (48 out of 53), and improved the survival of those who changed plan; although underpinning the significant differences in outcome, none of these process differences was itself significant. CONCLUSION: Endoscopic ultrasound significantly improves (quality-adjusted) survival, has the potential to reduce health-care resource use (not statistically significant) and is probably cost-effective (with 96% probability). We recommend research into the best time to evaluate new technologies. TRIAL REGISTRATION: ISRCTN1444215. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 39. See the HTA programme website for further project information.

Mode of data elicitation, acquisition and response to surveys: a systematic review.

BACKGROUND: Many studies in health sciences research rely on collecting participant-reported outcomes and attention is increasingly being paid to the mode of data collection. Consideration needs to be given to the validity of response via different modes and the impact that choice of mode might have on study conclusions. OBJECTIVES: (1) To provide an overview of the theoretical models of survey response and how they relate to health research; (2) to review all studies comparing two modes of administration for subjective outcomes and assess the impact of mode of administration on response quality; (3) to explore the impact of findings for key identified health-related measures; and (4) to inform the analysis of multimode studies. DATA SOURCES: A broad range of databases (for example EMBASE, PsychINFO, MEDLINE, EconLit, SPORTDiscus, etc.) were chosen to allow as comprehensive a selection as possible, and they were searched up until the end of 2004. REVIEW METHODS: The abstracts were reviewed against inclusion/exclusion criteria. Full papers were retrieved for all selected abstracts and then screened again using more detailed inclusion criteria related to the measures used. Papers that were still included were reviewed in full and detailed data extracted. At each stage, abstracts or papers were reviewed by a single reviewer. RESULTS: The search strategy identified 39,253 unique references, of which 2156 were considered as full papers, with 381 finally included in the review. Two features of mode were clearly associated with bias in response; however, none of the features of mode was associated with changes in precision. How the measure was administered, by an interviewer or by the person themselves, was highly significantly associated with bias (p < 0.001). A difference in sensory stimuli was also significant (p = 0.03). When both of these were present the average overall bias was < 1 point on a percentage scale. In terms of mediating factors, there was some suggestion that there was an interaction between both telephone and computer for data collection and date of publication, supporting the theory that differences disappear as new technologies become commonplace. Single-item measures were also related to greater degrees of bias than multi-item scales (p = 0.01). Individual analysis of the Short Form questionnaire-36 items and Minnesota Multiphasic Personality Inventory (MMPI) showed a varied pattern across the different subscales, with conflicting results between the two types of study. None of the MMPI measures used to detect deviant responding showed a relationship with the mode features tested. The limits of agreement analysis showed how variable measures were between modes at an individual rather than a group mean level. LIMITATIONS: The search strategy covered the period up to 2004, so any new and emerging technologies were not included. Not all potential mode features were tested and there was limited information on potential mediating factors. CONCLUSIONS: Researchers need to be aware of the different mode features that could have an impact on their results when selecting a mode of data collection for subjective outcomes. Further mode comparison studies, which manipulate mode features and directly assess impact over time, would be beneficial.

Social comparison and body image in adolescence: a grounded theory approach.

This study explored the use of social comparison appraisals in adolescents' lives with particular reference to enhancement appraisals which can be used to counter threats to the self. Social comparison theory has been increasingly used in quantitative research to understand the processes through which societal messages about appearance influence adolescents' body image. Little is known about the comparison processes used in their daily lives-to whom individuals compare (the target), on what individuals compare (the attribute) and how they compare (comparison appraisal). Based on the analysis of 20 in-depth grounded theory interviews with 12- to 14-year old boys and girls, we suggest that comparison processes are used for the purpose of identity development (core category). Given the opportunity, adolescents spontaneously describe a variety of targets, comparison attributes and comparison appraisals. Peers play an important part in making sense of media images and messages and provide comparison targets themselves. Adolescents are aware of societal standards and pressures and use a range of enhancement appraisals. The positive impact of these might depend on individual characteristics. Findings suggest that enhancement appraisals might have a protective function and should be considered in designing health promotion and prevention programmes.

Parents of Children with Autism using an Email Group: A Grounded Theory Study.

Parents of children with autism have difficulties obtaining adequate information and support to guide them in the care of their children. However, the growth of communication technologies such as email has created greater opportunities for accessing such resources. This article presents a grounded theory analysis of the messages sent to an email group by parents of children with autism. The core category emerging from the analysis indicates that the group functioned in making sense of autism. The core category comprises four categories: searching for meaning; adjusting to changes; providing support and encouragement; and narrative sharing of experiences. Although email groups function as a social support mechanism, we suggest that this is not the only legitimate function: such groups may contribute towards the development of parental representations of autism.

Examination of the validity of the Social Support Survey using confirmatory factor analysis.

The Social Support Survey (SSS), validated by Richman, Rosenfeld, and Hardy (1993), is a multidimensional self-report measure of social support tested with student athletes. The SSS contains eight dimensions of support. For each dimension of support the same four questions are posed. The SSS could, therefore, be scored in two ways: (a) to derive a score for the support dimensions; (b) to derive a score for the questions posed across all eight support dimensions. Confirmatory factor analyses of the SSS on 416 university athletes revealed poor fits to models for both the eight support dimensions and the four questions across all eight dimensions. This problem was clarified by using a multitrait-multimethod model, which led to improved model fit but revealed that most of the SSS items were two-dimensional. Caution should, therefore, be exercised in using the SSS as a measure of multidimensional social support.

The effect of type of physical activity measure on the relationship between body fatness and habitual physical activity in children: a meta-analysis.

BACKGROUND: The relationship between activity levels and body fat in children is unclear, despite a large number of studies. The issue is clouded by the wide variety of methods used to assess children's activity levels. It is important to assess whether the type of activity measure influences the fatness-activity relationship. This is a first step to uncovering the role of modifying variables such as gender, age, maturity, etc. PRIMARY OBJECTIVE: This study uses meta-analytic procedures to synthesize the results of such studies and to assess whether the type of activity measure used has an effect on the strength of the relationship observed. METHODS AND PROCEDURES: Fifty studies were located that satisfied the inclusion criteria. Seventy-eight per cent of the studies showed a negative relationship, 18% no relationship and 4% a positive relationship between physical activity and body fatness. Data were analysed using the meta-analytic procedures described by Rosenthal (Meta-analytic Procedures for Social Research, Sage, 1991). MAIN OUTCOMES AND RESULTS: The mean effect size indicated a small to moderate, inverse relationship (r = -0.16). Mean effect sizes differed significantly (F(3,52) = 8.04, p < 0.001) according to the activity measure used: questionnaire, r = -0.14; motion counters, r = -0.18; observation, r = -0.39; heart rate (HR), r = 0.00. Observation measures elicited a significantly stronger relationship with body fat than did questionnaire or heart rate measures (p < 0.05). However, there was no significant difference between the effect sizes elicited by observation and motion counters. Correlational analyses revealed no effect of age group or gender on the strength of the relationship between fatness and activity. CONCLUSIONS: This meta-analysis suggests there is a small to moderate relationship between body fat and activity in children. It is important to note, however, that the size of the relationship depends on the activity measure used. It is therefore recommended that direct measures of movement, such as observation or motion counter methods, are used to assess the relationship of activity levels with health.

Social support dimensions and components of performance in tennis.

The aim of this study was to explore the relationships between dimensions of social support and components of performance in tennis. A post-match performance measure was completed by 144 British tournament tennis players. Principal components analysis yielded eight components, labelled Execution of (Flexible) Plan, Loss of Composure, Feeling Flat, Positive Tension, Worry, Flow, Effective Tactics and Double Faults. Before the match, 46 players had also completed the Interpersonal Support Evaluation List. Stepwise regression analyses revealed significant effects of the Belonging and Appraisal dimensions of the Interpersonal Support Evaluation List on five of the performance components. The correlations between total support and four of these performance components were also significant. Logistic regression analyses revealed no significant effects of the dimensions of the Interpersonal Support Evaluation List or Total Support upon winning versus losing. Effects of social support upon performance were therefore only apparent when attention was focused on the components of performance.

Relationship between activity levels, aerobic fitness, and body fat in 8- to 10-yr-old children.

The relationships between children's activity, aerobic fitness, and fatness are unclear. Indirect estimates of activity, e.g., heart rate (HR) and recall, may mask any associations. The purpose of this study was to assess these relationships by using the Tritrac-R3D, a pedometer, and heart rate. Thirty-four children, ages 8-10 yr, participated in the study. The Tritrac and pedometer were worn for up to 6 days. HR was measured for 1 day. Activity measured by Tritrac or pedometer correlated positively to fitness in the whole group (Tritrac, r = 0.66; pedometer, r = 0.59; P < 0.01) and in boys and girls separately (P < 0.05) and correlated negatively to fatness in the whole group (r = -0.42, P < 0.05). In contrast, HR did not correlate significantly to fitness, and HR of >139 beats/min correlated positively to fatness in girls (r = 0.64, P < 0.05). This suggests that HR is misleading as a measure of activity. This study supports a positive relationship between activity and fitness and suggests a negative relationship between fatness and activity.

Personality, Preventive Health Behaviour and Comparative Optimism about Health Problems.

The aim was to test a model whereby personality influences preventive health behaviour which in turn influences comparative optimism about possible future health problems. Students (N 5 150) completed measures of personality (five-factor), preventive health behaviour and comparative optimism. The model was tested using structural equation modelling with observed variables. In the final model, agreeableness and conscientiousness had positive main effects and an interactive effect upon preventive health behaviour. Preventive health behaviour had a positive effect upon comparative optimism. In addition, extraversion had a direct positive effect (not mediated by preventive health behaviour) upon comparative optimism. It is speculated that agreeableness and conscientiousness combine to produce a general regard for social convention that is conducive to healthier behaviour. The effect of extraversion is explicable in terms of positive affectivity.

Validity of heart rate, pedometry, and accelerometry for predicting the energy cost of children's activities.

Heart rate telemetry is frequently used to estimate daily activity in children and to validate other methods. This study compared the accuracy of heart rate monitoring, pedometry, triaxial accelerometry, and uniaxial accelerometry for estimating oxygen consumption during typical children's activities. Thirty Welsh children (mean age 9.2 +/- 0.8 yr) walked (4 and 6 km/h) and ran (8 and 10 km/h) on a treadmill, played catch, played hopscotch, and sat and crayoned. Heart rate, body accelerations in three axes, pedometry counts, and oxygen uptake were measured continuously during each 4-min activity. Oxygen uptake was expressed as a ratio of body mass raised to the power of 0.75 [scaled oxygen uptake (sVO2)]. All measures correlated significantly (P < 0.001) with sVO2. A multiple-regression equation that included triaxial accelerometry counts and heart rate predicted sVO2 better than any measure alone (R2 = 0.85, standard error of the estimate = 9.7 ml.kg-0.75.min-1). The best of the single measures was triaxial accelerometry (R2 = 0.83, standard error of the estimate = 10.3 ml.kg-0.75.min-1). It is concluded that a triaxial accelerometer provides the best assessment of activity. Pedometry offers potential for large population studies.

What Coping Functions are Served when Health Behaviours are Used as Coping Strategies?

The aim was to clarify what coping functions are served by certain health behaviours when used as coping strategies. A preliminary questionnaire was used to identify individuals scoring high on eating (unhealthily), exercise or self- care as a coping strategy. These individuals completed a further questionnaire to elucidate the specific coping functions being served by their eating, exercise or self-care. Principal components analysis produced five coping function variables: Problem Solving, Feeling Better, Avoidance, Time Out and Prevention. Discriminant analysis (coping functions predicting coping strategy group) produced a Prevention with Problem Solving function, on which the exercise and self- care groups were high compared with the eating group; and a Time Out without Problem Solving function, on which the exercise group was high compared with the self- care group, the eating group being intermediate. Thus health behaviours used as coping strategies can serve not only problem-focused, emotion- focused and avoidance functions, but also time out and prevention functions.

Exercise motives and stages of change.

The aim was to examine how exercise motives differ across stages of change. British government employees completed questionnaires measuring exercise motives and exercise stage of change at baseline (N = 425) and at 3-month follow-up (247 of the original sample). Discriminant analysis was used to determine whether exercise motives (and age and gender) could collectively discriminate between baseline stages of change; and whether exercise motives could discriminate between those who stayed inactive, stayed active, became active or became inactive over the 3 months. Taken as a whole, and with some qualifications, the results suggest that extrinsic (specifically bodily) motives dominate during the early stages of exercise adoption, but that intrinsic (specifically enjoyment) motives are important for progression to and maintenance of actual activity. This is consistent with Deci and Ryan's (1985) self- determination theory. The implications for exercise promotion are discussed.

Measurement of physical activity in children with particular reference to the use of heart rate and pedometry.

Understanding the progression of physical activity behaviour from childhood to adulthood requires a valid, reliable and practical method of assessing activity levels which is appropriate for use in large groups. The measurement of physical activity in large scale research projects requires a method which is low in cost, agreeable to the study volunteer and accurate. Self-report can be used to determine adult activity patterns, but children lack the cognitive ability to recall details about their activity patterns. Heart rate telemetry has been used to estimate daily activity in children as a sole criterion and to validate commercial accelerometers. However, heart rate is an indirect estimate of physical activity which makes assumptions based on the linear relationship between heart rate and oxygen uptake. It is sensitive to emotional stress and body position, and takes longer to reach resting levels after physical exertion compared with oxygen uptake. It also lags behind movement, particularly as children's physical activity is spasmodic or intermittent in nature. One alternative is the pedometer. Many early studies reported that the pedometer is inaccurate and unreliable in measuring distance or counting steps. While reasonably accurate at mid range speeds, the accuracy of the pedometer decreases in very slow walking or very fast walking or running. However, more recent studies have examined the efficacy of using pedometers to assess daily or weekly activity patterns as a whole, and these have produced more promising results. In this regard, the pedometer has a number of advantages. It is very cheap, objective and does not interfere with daily activities and is therefore appropriate for use in population studies. Commercial accelerometers with a time-sampling mechanism offer further potential and could be used to provide a picture of the pattern of children's activity. As it has been observed that prolonged activity periods are not typically associated with childhood behaviour patterns, the use of a threshold value for 'aerobic' training stimulus is not appropriate as a cut-off value for physical activity. Instead, there is evidence to suggest that the total activity data measured by pedometers over limited periods of time may be more appropriate to assess how active children are.

Do resources bolster coping and does coping buffer stress? An organizational study with longitudinal aspect and control for negative affectivity.

Psychiatric workers facing redeployment completed questionnaire measures of stressors, resources (locus of control and perceived social support), coping, well-being, and negative affectivity, at baseline (N = 109) and 1 year later (loss of 7 participants). Regression analyses of the baseline data suggested that as stressors increased, so did avoidance coping, but less so for those high in internality or perceived social support. Problem-focused coping was bolstered by internality and emotion-focused coping by perceived social support. Other regression analyses, with a longitudinal aspect, suggested that stressors had a deleterious effect on well-being. Problem- and emotion-focused coping had beneficial effects, whereas avoidance coping had a (delayed) deleterious effect. These effects of coping were predominantly main and not buffering effects.