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Background: The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study.Methods/design: The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses.Trial Registration: The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 . [ABSTRACT FROM AUTHOR]

Purpose: Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.Methods and Materials: Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).Results: A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.Conclusions: Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT. [ABSTRACT FROM AUTHOR]

Background: Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. Methods: 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. Results: Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Changes in self-regulatory skills and automaticity over 3 months mediated the effect of the intervention on weight loss (β = .52, 95% Bias Corrected CI .17; .91). Conclusions: As hypothesised, 10TT enhanced self-regulatory skills and changes in self-regulatory skills and automaticity mediated the effect of the intervention on weight loss. This supports the proposition that self-regulatory training and habit formation are important features of weight loss interventions. Trial registration: This study was prospectively registered with the International Standard Randomised Controlled Trials () on 26 September 2011. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to determine whether combining potential biomarkers of fruit and vegetables is better at predicting FV intake within FV intervention studies than single biomarkers. Design: Data from a tightly controlled randomised FV intervention study (BIOFAV; all food provided and two meals/day on weekdays consumed under supervision) were used. A total of 30 participants were randomised to either 2, 5 or 8 portions FV/day for 4 weeks, and blood samples were collected at baseline and 4 weeks for plasma vitamin C and serum carotenoid analysis. The combined biomarker approach was also tested in three further FV intervention studies conducted by the same research team, with less strict dietary control (FV provided and no supervised meals). Results: The combined model containing all carotenoids and vitamin C was a better fit than either the vitamin C only ( P < 0.001) model or the lutein only ( P = 0.006) model in the BIOFAV study. The C-statistic was slightly lower in the lutein only model (0.85) and in the model based upon factor analysis (0.88), and much lower in the vitamin C model (0.68) compared with the full model (0.95). Results for the other studies were similar, although the differences between the models were less marked. Conclusions: Although there was some variation between studies, which may relate to the level of dietary control or participant characteristics, a combined biomarker approach to assess overall FV consumption may more accurately predict FV intake within intervention studies than the use of a single biomarker. The generalisability of these findings to other populations and study designs remains to be tested. Clinical trial Registration Number NCT01591057 (). [ABSTRACT FROM AUTHOR]

Purpose: To assess the effect of consuming a mid-morning almond snack (28 and 42 g) tested against a negative control of no almonds on acute satiety responses. Method: On three test days, 32 healthy females consumed a standard breakfast followed by 0, 28 or 42 g of almonds as a mid-morning snack and then ad libitum meals at lunch and dinner. The effect of the almond snacks on satiety was assessed by measuring energy intake (kcal) at the two ad libitum meals and subjective appetite ratings (visual analogue scales) throughout the test days. Results: Intake at lunch and dinner significantly decreased in a dose-dependent manner in response to the almond snacks. Overall, a similar amount of energy was consumed on all three test days indicating that participants compensated for the 173 and 259 kcals consumed as almonds on the 28 and 42 g test days, respectively. Subjective appetite ratings in the interval between the mid-morning snack and lunch were consistent with dose-dependent enhanced satiety following the almond snacks. However, in the interval between lunch and dinner, appetite ratings were not dependent on the mid-morning snack. Conclusion: Almonds might be a healthy snack option since their acute satiating effects are likely to result in no net increase in energy consumed over a day. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder.Methods: This study is a 2 × 2 partial factorial design RCT nested within an RCT of medical expulsive therapy for ureteric stone disease. Participants who supplied a mobile telephone number were randomly assigned to receive an SMS text pre-notification of questionnaire delivery or no pre-notification. Those who supplied an e-mail address were randomly assigned to receive a questionnaire reminder by e-mail or post. Participants could be randomly assigned to the pre-notification comparison or the reminder comparison or both. The primary outcome measure was response rate at each questionnaire time point.Results: Four hundred eighteen participants were randomly assigned to the SMS pre-notification comparison (80% were male, and the mean age was 41 years with a standard deviation (SD) of 11.1). The intervention had no effect on response rate at either questionnaire time point. In subgroup analyses, SMS pre-notification increased response rates in women but only at the first questionnaire time point. One hundred nineteen participants were randomly assigned to the reminder comparison (80% were male, and the mean age was 42 years with an SD of 12.1). There was no difference in response rate in those who received an e-mail reminder compared with those who received a postal reminder.Conclusions: SMS text pre-notification of questionnaire delivery and email delivery of questionnaire reminders did not improve response rates. There was some evidence to suggest that SMS text pre-notification may be effective in women, and further studies to investigate this may be warranted. E-mail reminders for participants to return their postal questionnaire could be advantageous given that response rates were similar following either type of reminder and the low cost of delivering an e-mail compared with a postal reminder. This is a substudy of the SUSPEND trial (ISCTRN69423238) (18 Nov. 2010). [ABSTRACT FROM AUTHOR]

Background Weight management interventions can be extended using mobile telephone technology to deliver support in real-time, real-world settings. The present study aimed to determine whether text messaging helped patients maintain or lose weight following a weight-loss programme. Methods In this controlled study, overweight and obese [ body mass index ( BMI) >30 kg m-2 or >28 kg m-2 with co-morbidities] adults who completed a weight-loss programme participated in an additional 12-week text message intervention [ Lifestyle, Eating and Activity Programme ( LEAP) Beep]. Patients were allocated goals for steps, fruit, vegetable and breakfast consumption. Patients regularly 'texted' their progress and received tailored practitioner feedback. Pre/post-intervention body weight, waist circumference ( WC), BMI, quality of life ( QOL), anxiety and depression measurements were compared retrospectively with a control group offered weight checks only. Results Compared to control ( n = 17), the intervention group's ( n = 17) body weight, WC and BMI reduced significantly (−1.6 versus 0.7 kg, P = 0.006; −2.2 versus 1.5 cm, P = 0.0005; −0.6 versus 0.7 kg m-2, P = 0.03, respectively). QOL and depression scores also improved (−6.8 versus 1 point, P = 0.134; −0.2 versus 0.2 points, P = 0.228). No difference was observed in anxiety scores between the groups. Intervention versus control group follow-up attendance improved significantly (4.4 versus 1.7 attendances, P = 0.0005). Conclusions LEAP Beep promoted losses in weight, WC and BMI, and improved QOL parameters and follow-up attendance. Text messaging is a cheap, portable, convenient and innovative medium facilitating goal setting, self-monitoring and information exchange. Further improvements to automation at the same time as maintaining individual support are necessary to ease practitioner burden. Text messaging offers cost-efficient dietetic input, opening up possibilities for practitioner-to-patient support and yields positive weight outcomes following initial weight loss. [ABSTRACT FROM AUTHOR]

Background: Foods with low glycaemic index (LGI) are reported to suppress appetite mainly in overweight population but have not been investigated in athletic adults. Objective: The aim of this study was to compare the short-term effects of LGI and high GI (HGI) meals over a day on subsequent subjective appetite sensation, energy intake, energy expenditure, energy balance and resting metabolic rate in physically active males. Methods: This cross-sectional randomized crossover study included 14 active males (mean ± SD; age 34.5 ± 8.9 years, body mass index 22.8 ± 2.1 kg m) to consume LGI and HGI meals on two separate days. On each trial day, participants consumed a breakfast in the laboratory and then left with a packed lunch, dinner and snacks. Appetite scores, energy intake and expenditure were assessed. Results: The area under the curve for appetite scores of the HGI trial was significantly smaller than that of the LGI trial during the laboratory period ( p = 0.027) and throughout the day ( p = 0.009). No significant differences in energy intake, energy expenditure, energy balance and resting metabolic rate were found between groups, between the trial days and between the corresponding post-trial days. Conclusions: These results show that frequent ingestion of the HGI meals, contrary to the previous reports, suppresses appetite more than that of LGI meals, but did not affect energy balance in physically active normal-weight males. [ABSTRACT FROM AUTHOR]

Background: It is important that response rates to postal surveys are as high as possible to ensure that the results are representative and to maximise statistical power. Previous research has suggested that any personalisation of approach helps to improve the response rate. This experiment tested whether personalising questionnaires by hand signing the covering letter improved the response rate compared with a non-personalised group where the investigator's signature on the covering letter was scanned into the document and printed. Methods: Randomised controlled trial. Questionnaires about surgical techniques of caesarean section were mailed to 3,799 Members and Fellows of the Royal College of Obstetricians and Gynaecologists resident in the UK. Individuals were randomly allocated to receive a covering letter with either a computer printed signature or a hand written signature. Two reminders were sent to non-respondents. The outcome measures were the proportion of questionnaires returned and their time to return. Results: The response rate was 79.1% (1506/1905) in the hand-signed group and 78.4% (1484/ 1894) in the scanned and printed signature group. There was no detectable difference between the groups in response rate or time taken to respond. Conclusion: No advantage was detected to hand signing the covering letter accompanying a postal questionnaire to health professionals. [ABSTRACT FROM AUTHOR]

Aim Peer-assisted learning ( PAL) has been positively evaluated during practice placements for medical, nursing and some allied health professional students. The aim of this study was to evaluate a PAL and small-group teaching model of dietetic practice placement education implemented in the UK setting as part of a quality improvement process. Methods A PAL placement model was adapted from a previously published Australian model, implemented and evaluated among dietetic students at King's College London and with their practice educators. Process evaluation with students and practice educators from PAL practice placements at two sites and traditional 1:1 practice placements at six sites consisted of weekly questionnaires and end-of-placement focus groups with 16 students and 35 practice educators. Perceptions of the barriers, concerns and strengths of the novel model were identified. Results Implementing the PAL placement model at just two sites increased placement capacity by 12 students, a 1.3-fold increase across London. Students on PAL placements reported a good learning experience (89.3 vs 67.7%; P < 0.001) and a satisfactory workload (83.1 vs 61.3%, P = 0.005) more frequently than those on a traditional 1:1 placement. Practice educators reported significantly less time undertaking direct student supervision on PAL practice placements compared to 1:1 placements (153 minutes/week 95% confidence interval ( CI) 124-183 vs 264 minutes/week 95% CI 204-324; P = 0.001). Conclusions PAL practice placements offer potential benefits to placement capacity and possibly quality. The detailed evaluation will enable others to implement similar novel models of dietetics placements. [ABSTRACT FROM AUTHOR]