• Effect of Routine Low-Dose Oxygen Supplementation on Death and Disability in Adults With Acute Stroke: The Stroke Oxygen Study Randomized Clinical Trial.

    25 December 2017

    Importance: Hypoxia is common in the first few days after acute stroke, is frequently intermittent, and is often undetected. Oxygen supplementation could prevent hypoxia and secondary neurological deterioration and thus has the potential to improve recovery. Objective: To assess whether routine prophylactic low-dose oxygen therapy was more effective than control oxygen administration in reducing death and disability at 90 days, and if so, whether oxygen given at night only, when hypoxia is most frequent, and oxygen administration is least likely to interfere with rehabilitation, was more effective than continuous supplementation. Design, Setting, and Participants: In this single-blind randomized clinical trial, 8003 adults with acute stroke were enrolled from 136 participating centers in the United Kingdom within 24 hours of hospital admission if they had no clear indications for or contraindications to oxygen treatment (first patient enrolled April 24, 2008; last follow-up January 27, 2015). Interventions: Participants were randomized 1:1:1 to continuous oxygen for 72 hours (n = 2668), nocturnal oxygen (21:00 to 07:00 hours) for 3 nights (n = 2667), or control (oxygen only if clinically indicated; n = 2668). Oxygen was given via nasal tubes at 3 L/min if baseline oxygen saturation was 93% or less and at 2 L/min if oxygen saturation was greater than 93%. Main Outcomes and Measures: The primary outcome was reported using the modified Rankin Scale score (disability range, 0 [no symptoms] to 6 [death]; minimum clinically important difference, 1 point), assessed at 90 days by postal questionnaire (participant aware, assessor blinded). The modified Rankin Scale score was analyzed by ordinal logistic regression, which yields a common odds ratio (OR) for a change from one disability level to the next better (lower) level; OR greater than 1.00 indicates improvement. Results: A total of 8003 patients (4398 (55%) men; mean [SD] age, 72 [13] years; median National Institutes of Health Stroke Scale score, 5; mean baseline oxygen saturation, 96.6%) were enrolled. The primary outcome was available for 7677 (96%) participants. The unadjusted OR for a better outcome (calculated via ordinal logistic regression) was 0.97 (95% CI, 0.89 to 1.05; P = .47) for oxygen vs control, and the OR was 1.03 (95% CI, 0.93 to 1.13; P = .61) for continuous vs nocturnal oxygen. No subgroup could be identified that benefited from oxygen. At least 1 serious adverse event occurred in 348 (13.0%) participants in the continuous oxygen group, 294 (11.0%) in the nocturnal group, and 322 (12.1%) in the control group. No significant harms were identified. Conclusions and Relevance: Among nonhypoxic patients with acute stroke, the prophylactic use of low-dose oxygen supplementation did not reduce death or disability at 3 months. These findings do not support low-dose oxygen in this setting. Trial Registration: ISRCTN Identifier: ISRCTN52416964.

  • How to connect the gap between clinical trials and clinical practice.

    7 December 2017

    Clinical research methods have been rapidly developing, and the design of clinical trials including traditional Chinese medicine is advancing. To a certain extent, all of these ensure that the results of clinical research are objective and scientific, but whether these results and the resulting guidelines or consensus have much practical significance on clinical practice is still controversial. The authors engage in both clinical practice and clinical research; they strongly feel that it is necessary to discuss the relationship between clinical trials and clinical practice. This essay discusses this relationship in four parts.

  • The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.

    12 January 2018

    Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement--a reporting guideline published in 1999--there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

  • A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial.

    8 December 2017

    BACKGROUND: There are few evidence-based mobile health solutions for treating adolescent obesity. The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months, compared to the Temple Street W82GO Healthy Lifestyles intervention. METHODS/DESIGN: The primary outcome measure is change in body mass index standardised deviation score at 12 months. The secondary aim is to compare the effect of treatment on secondary outcomes, including waist circumference, insulin sensitivity, quality of life, physical activity and psychosocial health. Adolescents with a body mass index at or above the 98th percentile (12 to 17 years) will be recruited from the Obesity clinic at Temple Street Children's University Hospital in Dublin, Ireland. W82GO is a family-based lifestyle change intervention delivered in two phases over 12 months. In the current study, participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application. One hundred and thirty-four participants will be randomised between the two study arms. An intention-to-treat analysis will be used to compare treatment differences between the groups at 12 months. DISCUSSION: The results of this study will be disseminated via open access publication and will provide important information for clinicians, patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity. TRIAL REGISTRATION: Clinicaltrials.gov NCT01804855.

  • Gestational Age Specific Postnatal Growth Curves for Singleton Babies in A Tertiary Hospital of Western Nepal.

    9 January 2018

    INTRODUCTION: Measurement of birth weight, crown-heel length, head circumference and chest circumference used to assess the intrauterine growth of a baby vary with altitude, race, gender, socioeconomic status, maternal size, and maternal diseases. The study aimed to construct centile charts for birth weight, crown-heel length and head circumference for new born at different gestational ages in Western Nepal. METHODS: This was a descriptive cross-sectional study done over a period of 15 months in a tertiary care hospital of Western Nepal. Birth weight, length, head circumference and chest circumference were measured within 12-24 hours of birth. Gestational age was estimated from the first day of last menstrual period and New Ballard's scoring system. Microsoft 2007 Excel and SPSS-16 was used for data analysis. Cole's Lambda Mu Sigma method was used for constructing centile curves. RESULTS: Out of 2000 babies analysed, 1910 samples were used to construct smoothed intrauterine growth curve of birth weight, crown-heel length, and head circumference from 33-42 weeks of gestation. Among all, 1147 (57.35%) were male and 853 (42.65%) were female, mean gestational age was 38.13±2.44 weeks. The means of birth weight, crown-heel length, head and chest circumference were 2744.78 gm, 47.80 cm, 33.18 cm, and 30.20 cm with standard deviations of 528.29, 3.124, 1.78, and 2.35 respectively. CONCLUSIONS: This necessitates the update in the existing growth charts and development in different geographical regions of a country.