Sequential multiple assignment randomized trial studies should report all key components: a systematic review.

OBJECTIVE: Sequential Multiple Assignment Randomized Trial (SMART) designs allow multiple randomizations of participants; this allows assessment of stage-specific questions (individual randomizations) and adaptive interventions (i.e. treatment strategies). We assessed the quality of reporting of the information required to design SMART studies. STUDY DESIGN AND SETTING: We systematically searched four databases (PubMed, Ovid, Web of Science and Scopus) for all trial reports, protocols, reviews, and methodological papers which mentioned SMART designs up to June 15, 2020. RESULTS: Of the 157 selected records, 12 (7.64%) were trial reports, 24 (15.29%) were study protocols, 91 (58%) were methodological papers, and 30 (19.1%) were review papers. All these trials were powered using stage-specific aims. Only four (33.33%) of these trials reported parameters required for sample size calculations. A small number of the trials (16.67 %) were interested in determining the best embedded adaptive interventions. Most of the trials did not report information about multiple testing adjustment. Furthermore, most of records reported designs that were mainly focused on stage-specific aims. CONCLUSIONS: Some features of SMART designs are seldomly reported and/or used. Furthermore, studies using this design tend to not adequately report information about all the design parameters, limiting their transparency and interpretability.

Prevalence and factors associated with poor performance in the 5-chair stand test: findings from the Cognitive Function and Ageing Study II and proposed Newcastle protocol for use in the assessment of sarcopenia.

BACKGROUND: Poor performance in the 5-chair stand test (5-CST) indicates reduced lower limb muscle strength. The 5-CST has been recommended for use in the initial assessment of sarcopenia, the accelerated loss of muscle strength and mass. In order to facilitate the use of the 5-CST in sarcopenia assessment, our aims were to (i) describe the prevalence and factors associated with poor performance in the 5-CST, (ii) examine the relationship between the 5-CST and gait speed, and (iii) propose a protocol for using the 5-CST. METHODS: The population-based study Cognitive Function and Ageing Study II recruited people aged 65 years and over from defined geographical localities in Cambridgeshire, Newcastle, and Nottingham. The study collected data for assessment of functional ability during home visits, including the 5-CST and gait speed. We used multinomial logistic regression to assess the associations between factors including the SARC-F questionnaire and the category of 5-CST performance: fast (<12 s), intermediate (12-15 s), slow (>15 s), or unable, with slow/unable classed as poor performance. We reviewed previous studies on the protocol used to carry out the 5-CST. RESULTS: A total of 7190 participants aged 65+ from the three diverse localities of Cognitive Function and Ageing Study II were included (54.1% female). The proportion of those with poor performance in the 5-CST increased with age, from 34.3% at age 65-69 to 89.7% at age 90+. Factors independently associated with poor performance included positive responses to the SARC-F questionnaire, physical inactivity, depression, impaired cognition, and multimorbidity (all P < 0.005). Most people with poor performance also had slow gait speed (57.8%) or were unable to complete the gait speed test (18.4%). We found variation in the 5-CST protocol used, for example, timing until a participant stood up for the fifth time or until they sat down afterwards. CONCLUSIONS: Poor performance in the 5-CST is increasingly common with age and is associated with a cluster of other factors that characterize risk for poor ageing such as physical inactivity, impaired cognition, and multimorbidity. We recommend a low threshold for performing the 5-CST in clinical settings and provide a protocol for its use.

Neuromuscular-blocking agents for tracheal intubation in pediatric patients (0-12 years): A systematic review and meta-analysis.

BACKGROUND: The benefit of using neuromuscular-blocking agents to facilitate tracheal intubation in pediatric patients remains unclear due to variations in design, treatments, and results among trials. By combining the available evidence, we aimed to establish whether scientific findings are consistent and can be generalized across various populations, settings, and treatments. METHODS: A systematic search for randomized controlled trials, related to the use of neuromuscular-blocking agents for tracheal intubation in American Society of Anesthesiologists class I-II participants (0-12 years), was performed. We considered all randomized controlled trials that studied whether intubation conditions and hemodynamics obtained by using neuromuscular-blocking agents were equivalent to those that were achieved without neuromuscular-blocking agents. We combined the outcomes in Review Manager 5.3 (RevMan, The Cochrane Collaboration) by pairwise random-effects meta-analysis using a risk ratio (RR) for intubation conditions and mean difference for hemodynamic values (mean [95% Confidence Intervals]). Heterogeneity among trials was explored using sensitivity analyses. RESULTS: We identified 22 eligible randomized controlled trials with 1651 participants. Overall, the use of a neuromuscular-blocking agent was associated with a clinically important increase in the likelihood of both excellent (RR = 1.41 [1.19-1.68], I2  = 76%) and acceptable (RR = 1.13 [1.07-1.19], I2  = 68%) intubating conditions. There is strong evidence that both unacceptable intubation conditions (RR = 0.35 [0.22-0.46], I2  = 23%) and failed first intubation attempts (RR = 0.25 [0.14-0.42], I2  = 0%) were less likely to occur when a neuromuscular-blocking agent was used compared with when it was not. Higher systolic or mean arterial pressures (mean difference = 13.3 [9.1-17.5] mm Hg, I2  = 69%) and heart rates (mean difference = 15.9 [11.0-20.8] beats/min, I2  = 75%) as well as a lower incidence of arrhythmias were observed when tracheal intubation was facilitated by neuromuscular-blocking agents. CONCLUSION: The use of a neuromuscular-blocking agent during light-to-moderate depth of anesthesia can improve the quality as well as the success rate of tracheal intubation and is associated with better hemodynamic stability during induction of anesthesia.

Factors associated with change in self-reported physical activity in the very old: The Newcastle 85+ study.

BACKGROUND: Higher physical activity (PA) has been linked to better health and functioning. Trajectories of PA and associated factors have been studied in older adults aged ≥65, but less is known about influences on PA change in the very old (aged ≥85). OBJECTIVE: To investigate factors associated with self-reported PA and PA change over time in very old adults. METHODS: 845 participants in the Newcastle 85+ Study were followed for health and functioning at 1.5-, 3-, and 5-year follow-up (wave 2 to 4). PA scores (range 0-18) and PA levels (low (PA scores 0-1), medium (2-6) and high (7-18)) were determined using a purpose-designed PA questionnaire. We used linear mixed models (LMM) to investigate factors associated with 5-year change in PA scores. RESULTS: Overall, men had higher mean PA scores than women (up to 2.27 points). The highest proportion of participants (42-48%) had medium levels of PA across the waves. Although most experienced decline-stability in moderate and increases in high PA levels were also observed. The fully adjusted LMM revealed a curvilinear annual decline in PA scores of 0.52 (0.13) (ß (SE), p<0.001), which decelerated by 0.07 (0.02) points (p<0.01) over time. The factors associated with low PA scores at baseline were female gender, higher waist-hip ratio, and no alcohol intake. Better self-rated and cognitive health and having fewer diseases were associated with higher PA scores. None were associated with the rate of change in PA over time. CONCLUSION: We observed a curvilinear trend and deceleration in PA scores decline in the very old. Men and those in better health and who drank alcohol were more physically active at baseline. None of the factors were associated with the rate of PA decline. Investigating those who maintain or increase levels of PA may inform interventions for at risk groups with PA decline.