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Background: The publication of a wrong conclusion from a randomised trial could have disastrous consequences. Missing data are unavoidable in most studies, but ignoring the problem may introduce bias to the results. Finding an appropriate way to deal with missing data is of paramount importance. We show how the choice of analysis method can impact on the conclusion of the trial with regard to the quality of life outcomes., Methods: Various analysis strategies (analysis of covariance, linear mixed effects model) with and without imputation were carried out to assess treatment difference in four quality of life outcomes in an example clinical trial., Results: Across all four quality of life outcomes, the various analysis approaches provided different estimates of treatment difference, with varying precision, using different numbers of patients. In some cases the decision about statistical significance differed. The results suggested that where possible extra effort should be made to retrieve missing responses. In the presence of data missing at random, simple imputation was inappropriate with multiple imputation or a linear mixed effects model more useful., Conclusion: Different trial conclusions were obtained for a variety of analysis approaches for the same outcome. Collecting as much data as possible is of paramount importance. Careful consideration should be taken when deciding on the most appropriate strategy for analysis when missing data are involved and this strategy should be pre-specified in the trial protocol. Making inappropriate decisions could result in inappropriate conclusions potentially leading to the adoption of a clinical intervention in error., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: To identify vision Patient-Reported Outcomes instruments relevant to glaucoma and assess their content validity., Methods: MEDLINE, MEDLINE in Process, EMBASE and SCOPUS (to January 2009) were systematically searched. Observational studies or randomised controlled trials, published in English, reporting use of vision instruments in glaucoma studies involving adults were included. In addition, reference lists were scanned to identify additional studies describing development and/or validation to ascertain the final version of the instruments. Instruments' content was then mapped onto a theoretical framework, the World Health Organization International Classification of Functioning, Disability and Health. Two reviewers independently evaluated studies for inclusion and quality assessed instrument content., Results: Thirty-three instruments were identified. Instruments were categorised into thirteen vision status, two vision disability, one vision satisfaction, five glaucoma status, one glaucoma medication related to health status, five glaucoma medication side effects and six glaucoma medication satisfaction measures according to each instruments' content. The National Eye Institute Visual Function Questionnaire-25, Impact of Vision Impairment and Treatment Satisfaction Survey-Intraocular Pressure had the highest number of positive ratings in the content validity assessment., Conclusion: This study provides a descriptive catalogue of vision-specific PRO instruments, to inform the choice of an appropriate measure of patient-reported outcomes in a glaucoma context.

Objective: To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD)., Design: Multicentre, pragmatic randomised trial (with parallel preference groups)., Setting: 21 hospitals in the United Kingdom., Participants: 357 randomised participants (178 surgical, 179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months., Intervention: The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care., Main Outcome Measures: The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications., Main Results: Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group., Conclusion: At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD., Trial Registration: ISRCTN15517081.

Objective: To examine whether supplementation with multivitamins and multiminerals influences self reported days of infection, use of health services, and quality of life in people aged 65 or over., Design: Randomised, placebo controlled trial, with blinding of participants, outcome assessors, and investigators., Setting: Communities associated with six general practices in Grampian, Scotland., Participants: 910 men and women aged 65 or over who did not take vitamins or minerals., Interventions: Daily multivitamin and multimineral supplementation or placebo for one year., Main Outcome Measures: Primary outcomes were contacts with primary care for infections, self reported days of infection, and quality of life. Secondary outcomes included antibiotic prescriptions, hospital admissions, adverse events, and compliance., Results: Supplementation did not significantly affect contacts with primary care and days of infection per person (incidence rate ratio 0.96, 95% confidence interval 0.78 to 1.19 and 1.07, 0.90 to 1.27). Quality of life was not affected by supplementation. No statistically significant findings were found for secondary outcomes or subgroups., Conclusion: Routine multivitamin and multimineral supplementation of older people living at home does not affect self reported infection related morbidity., Trial Registration: ISRCTN: 66376460.

Objective: To determine the impact of a national strategy to promote implementation of a guideline on the management of mild, non-proteinuric hypertension in pregnancy., Design: Simple, interrupted time series analysis., Setting: Four maternity units in Scotland., Population: Women delivering a live or stillborn baby., Methods: Dissemination of the guideline under the auspices of a national clinical effectiveness programme, supported by a national launch meeting and feedback from a survey of obstetricians highlighting aspects of care that could be improved., Main Outcome Measures: Appropriateness of initial investigation and subsequent clinical management, and costs of guideline development and implementation activities., Data Collection: Twenty-four months pre-intervention and 12 months post-intervention data were abstracted from a random sample of case notes., Results: Initial investigation was consistent with recommendations for 59.9% out of 1263 women and subsequent clinical management for 67.6% out of 1081 in whom a diagnosis could be made from available data. There were no significant changes in the appropriateness of initial investigation (10.6%; 95% confidence interval [CI] -0.1% to 19.3%; decreasing by 1.2% per month post-implementation, 95% CI -2.5% to 0.1%) or clinical management (-0.3%; 95% CI -8.7% to 11.2%). Guideline development and implementation cost an estimated pound 2784 per maternity unit in Scotland., Conclusions: Clinical care of mild hypertension in pregnancy remains highly inconsistent. The lack of the intervention effect may be related to the complexity of the guideline recommendations and the nature of the implementation strategy.