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Background\ud \ud Gastrostomy feeding is commonly used to support patients with amyotrophic lateral sclerosis who develop severe dysphagia. Although recommended by both the American Academy of Neurology and the European Federation of Neurological Societies, currently little evidence indicates the optimum method and timing for gastrostomy insertion. We aimed to compare gastrostomy insertion approaches in terms of safety and clinical outcomes.\ud \ud Methods\ud \ud In this large, longitudinal, prospective cohort study (ProGas), we enrolled patients with a diagnosis of definite, probable, laboratory supported, or possible amyotrophic lateral sclerosis who had agreed with their treating clinicians to undergo gastrostomy at 24 motor neuron disease care centres or clinics in the UK. The primary outcome was 30-day mortality after gastrostomy. This study was registered on the UK Clinical Research Network database, identification number 9923.\ud \ud Findings\ud \ud Between Nov 2, 2010, and Jan 31, 2014, 345 patients were recruited of whom 330 had gastrostomy. 163 (49%) patients underwent percutaneous endoscopic gastrostomy, 121 (37%) underwent radiologically inserted gastrostomy, 43 (13%) underwent per-oral image-guided gastrostomy, and three (1%) underwent surgical gastrostomy. 12 patients (4%, 95% CI 2·1–6·2) died within the first 30 days after gastrostomy: five (3%) of 163 after percutaneous endoscopic gastrostomy, four (3%) of 121 after radiologically inserted gastrostomy, and three (7%) of 43 after per-oral image-guided gastrostomy (p=0·46). Including repeat attempts in 14 patients, 21 (6%) of 344 gastrostomy procedures could not be completed: 11 (6%) of 171 percutaneous endoscopic gastrostomies, seven (6%) of 121 radiologically inserted gastrostomies, and three (6%) of 45 per-oral image-guided gastrostomies (p=0·947).\ud \ud Interpretation\ud \ud The three methods of gastrostomy seemed to be as safe as each other in relation to survival and procedural complications. In the absence of data from randomised trials, our findings could inform clinicians and patients in reaching decisions about gastrostomy and will stimulate further research into the nutritional management in patients with amyotrophic lateral sclerosis.\ud \ud

Background\ud Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months.\ud \ud Methods\ud Participants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mailout. Interventions: Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mailout of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected.\ud \ud Results\ud Forty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups.\ud \ud Conclusions\ud The main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.

This cross-sectional study aimed to investigate the relationship between quality of life (QoL), physical activity (PA), diet and overweight status in children 11 to 15 years old.\ud \ud Participants (N = 1,771) children with self-reported physical activity and QoL outcome data.\ud \ud Cross-sectional survey of four secondary schools, using the PedsQL and EQ-5D QoL instruments; the CAPANS physical activity instrument and a food intake screener questionnaire.\ud \ud The correlational analysis indicates little or no relationship between self-reported QoL, BMI and moderate to vigorous PA. We found no statistically significant differences between the two groups of children, who achieved the recommended PA guidelines and those who did not, on any of the dimensions of the PedsQL and the EQ-5D utility score. Only on the EQ-5D VAS dimensions score was there a statistically significant difference. Children who self-reported a BMI of overweight to obese had significantly lower QoL on both dimensions of the EQ-5D and every dimension of the PedsQL apart from School functioning.\ud \ud Overall this study showed mixed results for pupils achieving the recommended targets for physical activity and diet and their relationship with QoL. Hence, further study into PA and diet and their effects on QoL is needed.\ud

Objectives: To determine which of two methods of case note review – holistic (implicit) and criterion-based (explicit) – provides the most useful and reliable information for quality and safety of care, and the level of agreement within and between groups of health-care professionals when they use the two methods to review the same record. To explore the process–outcome relationship between holistic and criterion-based quality-of-care measures and hospital-level outcome indicators. © 2010 Crown Copyright\ud \ud \ud

Health-Related Quality of Life (HRQoL) measures are becoming increasingly used in clinical trials as primary outcome measures. Investigators are now asking statisticians for advice on how to analyse studies that have used HRQoL outcomes.\ud \ud HRQoL outcomes, like the SF-36, are usually measured on an ordinal scale. However, most investigators assume that there exists an underlying continuous latent variable that measures HRQoL, and that the actual measured outcomes (the ordered categories), reflect contiguous intervals along this continuum.\ud \ud The ordinal scaling of HRQoL measures means they tend to generate data that have discrete, bounded and skewed distributions. Thus, standard methods of analysis such as the t-test and linear regression that assume Normality and constant variance may not be appropriate. For this reason, conventional statistical advice would suggest that non-parametric methods be used to analyse HRQoL data. The bootstrap is one such computer intensive non-parametric method for analysing data.\ud \ud We used the bootstrap for hypothesis testing and the estimation of standard errors and confidence intervals for parameters, in four datasets (which illustrate the different aspects of study design). We then compared and contrasted the bootstrap with standard methods of analysing HRQoL outcomes. The standard methods included t-tests, linear regression, summary measures and General Linear Models.\ud \ud Overall, in the datasets we studied, using the SF-36 outcome, bootstrap methods produce results similar to conventional statistical methods. This is likely because the t-test and linear regression are robust to the violations of assumptions that HRQoL data are likely to cause (i.e. non-Normality). While particular to our datasets, these findings are likely to generalise to other HRQoL outcomes, which have discrete, bounded and skewed distributions. Future research with other HRQoL outcome measures, interventions and populations, is required to confirm this conclusion.\ud

BACKGROUND: \ud \ud The SF-6D is a new single summary preference-based measure of health derived from the SF-36. Empirical work is required to determine what is the smallest change in SF-6D scores that can be regarded as important and meaningful for health professionals, patients and other stakeholders.\ud \ud OBJECTIVES: \ud \ud To use anchor-based methods to determine the minimally important difference (MID) for the SF-6D for various datasets.\ud \ud METHODS: \ud \ud All responders to the original SF-36 questionnaire can be assigned an SF-6D score provided the 11 items used in the SF-6D have been completed. The SF-6D can be regarded as a continuous outcome scored on a 0.29 to 1.00 scale, with 1.00 indicating "full health".\ud \ud Anchor-based methods examine the relationship between an health-related quality of life (HRQoL) measure and an independent measure (or anchor) to elucidate the meaning of a particular degree of change. One anchor-based approach uses an estimate of the MID, the difference in the QoL scale corresponding to a self-reported small but important change on a global scale. Patients were followed for a period of time, then asked, using question 2 of the SF-36 as our global rating scale, (which is not part of the SF-6D), if there general health is much better (5), somewhat better (4), stayed the same (3), somewhat worse (2) or much worse (1) compared to the last time they were assessed. We considered patients whose global rating score was 4 or 2 as having experienced some change equivalent to the MID. In patients who reported a worsening of health (global change of 1 or 2) the sign of the change in the SF-6D score was reversed (i.e. multiplied by minus one). The MID was then taken as the mean change on the SF-6D scale of the patients who scored (2 or 4).\ud \ud RESULTS: \ud \ud This paper describes the MID for the SF-6D from seven longitudinal studies that had previously used the SF-36.\ud \ud CONCLUSIONS: \ud \ud From the seven reviewed studies (with nine patient groups) the MID for the SF-6D ranged from 0.010 to 0.048, with a weighted mean estimate of 0.033 (95% CI: 0.029 to 0.037). The corresponding Standardised Response Means (SRMs) ranged from 0.11 to 0.48, with a mean of 0.30 and were mainly in the "small to moderate" range using Cohen's criteria, supporting the MID results. Using the half-standard deviation (of change) approach the mean effect size was 0.051 (range 0.033 to 0.066). Further empirical work is required to see whether or not this holds true for other patient groups and populations.\ud

OBJECTIVES: To assess the practicality and validity of using the SF-36 in a community-dwelling population over 65 years old, and obtain population scores in this age group.\ud \ud DESIGN: \ud Postal survey, using a questionnaire booklet containing the SF-36 and other health related items, of all those aged 65 or over registered with twelve general practices. Non-respondents received up to two reminders at three-weekly intervals.\ud \ud SETTING: \ud Twelve randomly selected general practices in Sheffield.\ud \ud SAMPLE: \ud 9897 subjects aged 65 to 104.\ud \ud MAIN OUTCOME MEASURES: \ud Scores for the eight dimensions of the SF-36 and a modified version of the physical functioning dimension.\ud \ud RESULTS: \ud The SF-36 achieved a response rate of 82% (n=8117) and dimension completion rates of 86.4% to 97.7%. Internal consistency measured by Cronbach’s a exceeded 0.80 for all dimensions except social functioning. These results compare favourably with postal surveys of younger adults. Scores for older adults were calculated by age and sex. Comparison with data from younger people showed how physical health declines steeply with age, in marked contrast with mental health.\ud \ud CONCLUSIONS: \ud The SF-36 is a practical and valid instrument to use in postal surveys of older people living in the community. The population scores provided here may facilitate its use in future surveys of older adults.\ud

BACKGROUND: To assist clinicians and researchers in choosing outcome measures for patients with chronic obstructive pulmonary disease attending routine outpatient clinics, a comparative assessment was undertaken of four questionnaires designed to reflect the patients' perception of their physical and emotional health in terms of their feasibility, validity, reliability, and responsiveness to health change. METHODS: Two condition specific questionnaires, the St George's Respiratory Questionnaire (SGRQ) and Guyatt's Chronic Respiratory Questionnaire (CRQ), and two generic questionnaires, the Short Form-36 Health Survey (SF-36) and Euroqol (EQ), were compared for their discriminative and evaluative properties. Spirometric tests and a walking test were also performed. One hundred and fifty six adults who were clinically judged to have COPD and who attended an outpatient chest clinic were assessed at recruitment and six and 12 months later. Patients were also asked whether their health had changed since their last assessment. RESULTS: Completion rates and consistency between items for dimensions of the SGRQ were lower than for dimensions of the other questionnaires. The distributions of responses were skewed for certain dimensions in all questionnaires except the CRQ. Validity was supported for all instruments insofar as patients' scores were associated with differences in disease severity. The generic questionnaires better reflected other health problems. All instruments were reliable over time. The condition specific questionnaires were more responsive between baseline and first follow up visit but this difference did not persist. While certain dimensions of the SF-36 were responsive to patient perceived changes, this did not apply to the derived single index of the EQ. The rating scale of the EQ, however, provided a quick and easy indicator of change. CONCLUSIONS: Evidence from this study supports the CRQ and the SF-36 as comprehensive outcome measures for patients with longstanding COPD. \ud

Background\ud Health Related Quality of Life (HRQoL) measures are becoming more frequently used in clinical trials and health services research, both as primary and secondary endpoints. Investigators are now asking statisticians for advice on how to plan and analyse studies using HRQoL measures, which includes questions on sample size. Sample size requirements are critically dependent on the aims of the study, the outcome measure and its summary measure, the effect size and the method of calculating the test statistic. The SF-6D is a new single summary preference-based measure of health derived from the SF-36 suitable for use clinical trials and in the economic evaluation of health technologies.\ud \ud Objectives\ud To describe and compare two methods of calculating sample sizes when using the SF-6D in comparative clinical trials and to give pragmatic guidance to researchers on what method to use.\ud \ud Methods\ud We describe two main methods of sample size estimation. The parametric (t-test) method assumes the SF-6D data is continuous and normally distributed and that the effect size is the difference between two means. The non-parametric (Mann-Whitney MW) method assumes the data are continuous and not normally distributed and the effect size is defined in terms of the probability that an observation drawn at random from population Y would exceed an observation drawn at random from population X. We used bootstrap computer simulation to compare the power of the two methods for detecting a shift in location.\ud \ud Results\ud This paper describes the SF-6D and retrospectively calculated parametric and nonparametric effect sizes for the SF-6D from a variety of studies that had previously used the SF-36. Computer simulation suggested that if the distribution of the SF-6D is reasonably symmetric then the t-test appears to be more powerful than the MW test at detecting differences in means. Therefore if the distribution of the SF-6D is symmetric or expected to be reasonably symmetric then parametric methods should be used for sample size calculations and analysis. If the distribution of the SF-6D is skewed then the MW test appears to be more powerful at detecting a location shift (difference in means) than the t-test. However the differences in power (between the t and MW tests) are small and decrease as the sample size increases.\ud \ud Conclusions\ud We have provided a clear description of the distribution of the SF-6D and believe that the mean is an appropriate summary measure for the SF-6D when it is to be used in clinical trials and the economic evaluation of new health technologies. Therefore pragmatically we would recommend that parametric methods be used for sample size calculation and analysis when using the SF-6D.