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ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.
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Low Back Pain/physiopathology , Osteoarthritis, Knee/physiopathology , Exercise Therapy/standards , Obesity/complications , Treatment Outcome , Healthy Lifestyle , Knee Joint/physiologyABSTRACT
Aims: Several scoring systems have been developed for diagnosis of appendicitis. This study aims to systematically explore how those scores were derived and validated, and to compare their performance. Study Design: Systematic review. Place and Duration of Study: We searched Medline from 1949 and EMBASE from 1974 to March 2012 to identify relevant articles published in English. Methodology: Information about model development and performance was extracted. The “risk of bias” assessment tool was developed based on a critical appraisal guide for clinical prediction rules. Calibration (O/E ratio) and discrimination (C-statistic) coefficients were estimated. A meta-analysis was applied to pool calibration coefficients and Cstatistics. Results: Forty-four out of 468 studies were eligible. Of these, 14 developed or modified diagnostic scoring systems and 30 validated existing models. Four scores had been most frequently validated, i.e., Alvarado, modified Alvarado, Fenyo, and Eskelinen. Among them, only the Eskelinen model was derived based on a multivariate regression whereas the rest used univariate or non-statistical methodology. All studies reported very good but imprecise calibration. For discrimination, the pooled C-statistics for these corresponding scores were 0.77, 0.86, 0.81, and 0.84 respectively. In the external validation, the discriminative performance decreased about 25.3% and 10.1% for the Alvarado and Fenyo scores respectively. Conclusion: The research methods for scoring systems of appendicitis were inconsistent. More efficient scoring systems which have been internally and externally validated are required.
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The genetic polymorphisms at the 16th (Arg-Gly) and 27th (GlnGlu) amino acid positions of the ß2-adrenergic receptor (ADRB2) may be linked to various asthma-related phenotypes. These include the adverse effects on lung function known to occur following the regular use of albuterol. The study aimed to determine the association between these two ADRB2 SNPs, their haplotypes and the phenotypes in Thai asthmatic patients. One-hundred and thirty asthmatic patients were genotyped at the Arg16Gly and Gln27Glu polymorphisms. Demographic data, disease severities, pulmonary function tests and medication usages were recorded for each patient. The frequencies of the Arg16 and Gln27 alleles were found to be 56.9% and 91.2%, respectively, while the linkage disequilibrium coefficient between the two SNPs was 0.36. Three haplotypes were estimated, i.e. Arg-Gln, Gly-Gln and Gly-Glu with frequencies of 148 (56.9%), 89 (34.2%) and 23 (8.9%), respectively. The mean percentages for predicted FEV1 (%FEV1) for these corresponding haplotypes were 73.5 (SD = 16.3), 72.4 (SD = 17.4)and 80.7 (SD = 13.1), respectively (p = 0.258). Additionally, the number of hospitalizations, emergency visits and inhaled corticosteroid/longacting ß2-agonist (ICS/ LABA) usages were lower in Gln/Glu subjects than for Gln/Gln genotyped patients, with values of 0% versus 11.9% (p = 0.122) for hospitalizations;4.5% versus 18.8% (p = 0.121) for emergency visits; and 50% versus 76.6%, (p = 0.042) for ICS/LABA usages. The presence of the Glu27 allele in Thai asthmatic patients is associated with a decreased asthma severity, higher %FEV1 values, less frequent hospitalizations and emergency visits, and decreased ICS/LABA usage.