Varsha Parag

Electronic cigarettes for smoking cessation: a randomised controlled trial

BACKGROUND Electronic cigarettes (e-cigarettes) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts. We investigated whether e-cigarettes are more effective than nicotine patches at helping smokers to quit. METHODS We did this pragmatic randomised-controlled superiority trial in Auckland, New Zealand, between Sept 6, 2011, and July 5, 2013. Adult (≥18 years) smokers wanting to quit were randomised (with computerised block randomisation, block size nine, stratified by ethnicity [Māori; Pacific; or non-Māori, non-Pacific], sex [men or women], and level of nicotine dependence [>5 or ≤5 Fagerström test for nicotine dependence]) in a 4:4:1 ratio to 16 mg nicotine e-cigarettes, nicotine patches (21 mg patch, one daily), or placebo e-cigarettes (no nicotine), from 1 week before until 12 weeks after quit day, with low intensity behavioural support via voluntary telephone counselling. The primary outcome was biochemically verified continuous abstinence at 6 months (exhaled breath carbon monoxide measurement <10 ppm). Primary analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000866000. FINDINGS 657 people were randomised (289 to nicotine e-cigarettes, 295 to patches, and 73 to placebo e-cigarettes) and were included in the intention-to-treat analysis. At 6 months, verified abstinence was 7·3% (21 of 289) with nicotine e-cigarettes, 5·8% (17 of 295) with patches, and 4·1% (three of 73) with placebo e-cigarettes (risk difference for nicotine e-cigarette vs patches 1·51 [95% CI -2·49 to 5·51]; for nicotine e-cigarettes vs placebo e-cigarettes 3·16 [95% CI -2·29 to 8·61]). Achievement of abstinence was substantially lower than we anticipated for the power calculation, thus we had insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes. We identified no significant differences in adverse events, with 137 events in the nicotine e-cigarettes group, 119 events in the patches group, and 36 events in the placebo e-cigarettes group. We noted no evidence of an association between adverse events and study product. INTERPRETATION E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events. Uncertainty exists about the place of e-cigarettes in tobacco control, and more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels. FUNDING Health Research Council of New Zealand.

Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review

This systematic review of population-based studies of the incidence and early (21 days to 1 month) case fatality of stroke is based on studies published from 1970 to 2008. Stroke incidence (incident strokes only) and case fatality from 21 days to 1 month post-stroke were analysed by four decades of study, two country income groups (high-income countries and low to middle income countries, in accordance with the World Banks country classification) and, when possible, by stroke pathological type: ischaemic stroke, primary intracerebral haemorrhage, and subarachnoid haemorrhage. This Review shows a divergent, statistically significant trend in stroke incidence rates over the past four decades, with a 42% decrease in stroke incidence in high-income countries and a greater than 100% increase in stroke incidence in low to middle income countries. In 2000-08, the overall stroke incidence rates in low to middle income countries have, for the first time, exceeded the level of stroke incidence seen in high-income countries, by 20%. The time to decide whether or not stroke is an issue that should be on the governmental agenda in low to middle income countries has now passed. Now is the time for action.

Predictors of Depression after Stroke A Systematic Review of Observational Studies

Background and Purpose— Although depression is an important sequelae of stroke, there is uncertainty regarding its frequency and outcome. Methods— We undertook a systematic review of all published nonexperimental studies (to June 2004) with prospective consecutive patient recruitment and quantification of depressive symptoms/illness after stroke. Results— Data were available from 51 studies (reported in 96 publications) conducted between 1977 and 2002. Although frequencies varied considerably across studies, the pooled estimate was 33% (95% confidence interval, 29% to 36%) of all stroke survivors experiencing depression. Differences in case mix and method of mood assessment could explain some of the variation in estimates across studies. The data also suggest that depression resolves spontaneously within several months of onset in the majority of stroke survivors, with few receiving any specific antidepressant therapy or active management. Conclusions— Depression is common among stroke patients, with the risks of occurrence being similar for the early, medium, and late stages of stroke recovery. There is a pressing need for further research to improve clinical practice in this area of stroke care.

Cardiovascular risk factors after antenatal exposure to betamethasone : 30-year follow-up of a randomised controlled trial

BACKGROUND Antenatal betamethasone treatment is widely used for the prevention of neonatal respiratory distress syndrome in preterm infants and substantially reduces neonatal mortality and morbidity. Fetal exposure to excess glucocorticoids has been proposed as one of the core mechanisms of the fetal origins of adult disease hypothesis. We assessed whether antenatal exposure to betamethasone for the prevention of neonatal respiratory distress syndrome affects cardiovascular risk factors at 30 years of age. METHODS We followed up at age 30 years 534 individuals whose mothers participated in a double-blind, placebo-controlled, randomised trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome. Mothers received two doses of betamethasone or placebo given by intramuscular injection 24 h apart. Follow-up assessments included anthropometry; measurement of blood pressure, blood lipids (after overnight fasting), and early morning cortisol levels; and a 75 g oral glucose tolerance test. FINDINGS There were no differences between those exposed to betamethasone and to placebo in body size, blood lipids, blood pressure, plasma cortisol, prevalence of diabetes, or history of cardiovascular disease. After a 75 g oral glucose tolerance test, participants exposed to betamethasone had higher plasma insulin concentrations at 30 min (60.5 vs 52.0 mIU/L; ratio of geometric means 1.16 [95% CI 1.03 to 1.31], p=0.02) and lower glucose concentrations at 120 min (4.8 vs 5.1 mmol/L; difference -0.26 mmol/L [-0.53 to 0.00], p=0.05) than did those exposed to placebo. INTERPRETATION Antenatal exposure to betamethasone might result in insulin resistance in adult offspring, but has no clinical effect on cardiovascular risk factors at 30 years of age. Thus, obstetricians should continue to use a single course of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome.

Incidence of traumatic brain injury in New Zealand: a population-based study

BACKGROUND Traumatic brain injury (TBI) is the leading cause of long-term disability in children and young adults worldwide. However, accurate information about its incidence does not exist. We aimed to estimate the burden of TBI in rural and urban populations in New Zealand across all ages and TBI severities. METHODS We did a population-based incidence study in an urban (Hamilton) and rural (Waikato District) population in New Zealand. We registered all cases of TBI (admitted to hospital or not, fatal or non-fatal) that occurred in the population between March 1, 2010, and Feb 28, 2011, using multiple overlapping sources of information. We calculated incidence per 100,000 person-years with 95% CIs using a Poisson distribution. We calculated rate ratios [RRs] to compare the age-standardised rates between sex, ethnicity, and residency (urban, rural) groups. We used direct standardisation to age-standardise the rates to the world population. RESULTS The total incidence of TBI per 100,000 person-years was 790 cases (95% CI 749-832); incidence per 100,000 person-years of mild TBI was 749 cases (709-790) and of moderate to severe TBI was 41 cases (31-51). Children (aged 0-14 years) and adolescents and young adults (aged 15-34 years) constituted almost 70% of all TBI cases. TBI affected boys and men more than women and girls (RR 1·77, 95% CI 1·58-1·97). Most TBI cases were due to falls (38% [516 of 1369]), mechanical forces (21% [288 of 1369]), transport accidents (20% [277 of 1369]), and assaults (17% [228 of 1369]). Compared with people of European origin, Maori people had a greater risk of mild TBI (RR 1·23, 95% CI 1·08-1·39). Incidence of moderate to severe TBI in the rural population (73 per 100,000 person-years [95% CI 50-107) was almost 2·5 times greater than in the urban population (31 per 100 000 person-years [23-42]). INTERPRETATION Our findings suggest that the incidence of TBI, especially mild TBI, in New Zealand is far greater than would be estimated from the findings of previous studies done in other high-income countries. Our age-specific and residency-specific data for TBI incidence overall and by mechanism of injury should be considered when planning prevention and TBI care services. FUNDING Health Research Council of New Zealand.

A Theory-Based Video Messaging Mobile Phone Intervention for Smoking Cessation: Randomized Controlled Trial

Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called “STUB IT”) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. Methods A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. Results The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation. Trial registration Australian New Zealand Clinical Trials Registry Number: ACTRN12606000476538; http://www.anzctr.org.au/trial_view.aspx?ID=81688 (Archived by WebCite at http://www.webcitation.org/5umMU4sZi)

Blood pressure indices and cardiovascular disease in the Asia-Pacific region: a pooled analysis

Abstract—This article aims to compare the importance of systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and pulse pressure (PP) as risk factors for stroke and ischemic heart disease and to assess whether the patterns are consistent by age and gender. Cox proportional-hazards regression, adjusted for cholesterol and smoking, was used to assess the associations of the 4 BP indices with stroke and ischemic heart disease by age and gender. The relative importance of individual indices was assessed with a hazard ratios for a 1-SD change in BP and by likelihood-ratio &khgr;2 tests. The influence of >1 BP index in the Cox model was also estimated. The analyses demonstrated similar associations of SBP, DBP, and MAP with both fatal stroke and ischemic heart diseases, which were stronger than those of PP. Both SBP and MAP tended to be more important in the regression model than DBP or PP. In Cox models including DBP, addition of SBP improved the goodness of fit at all ages and for both genders. However, in Cox models including SBP, addition of DBP typically resulted in little incremental benefit over and above that of SBP alone. These data suggest that if time or resources are highly constrained, such as in much-needed epidemiologic surveys in developing countries, very little is lost from only measuring SBP.

Antenatal exposure to betamethasone: psychological functioning and health related quality of life 31 years after inclusion in randomised controlled trial

Abstract Objectives To determine if antenatal exposure to betamethasone for the prevention of neonatal respiratory distress syndrome alters psychological functioning and health related quality of life in adulthood. Design Follow-up of the first and largest double blind, placebo controlled, randomised trial of a single course of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome. Setting Tertiary obstetric hospital in Auckland, New Zealand. Participants 192 adult offspring, mean age 31 years, of mothers who took part in a randomised controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome (87 exposed to betamethasone and 105 exposed to placebo). Interventions Mothers received two doses of betamethasone or placebo 24 hours apart. Main outcome measures Cognitive functioning assessed with Wechsler abbreviated scale of intelligence; working memory and attention assessed with Benton visual retention test, paced auditory serial addition test, and Brown attention deficit disorder scale; psychiatric morbidity assessed with Beck depression inventory II, state-trait anxiety inventory, and schizotypy traits questionnaire; handedness assessed with Edinburgh handedness inventory; health related quality of life assessed with short form 36 health survey. Results No differences were found between groups exposed to betamethasone and placebo in cognitive functioning, working memory and attention, psychiatric morbidity, handedness, or health related quality of life. Conclusions Prenatal exposure to a single course of betamethasone does not alter cognitive functioning, working memory and attention, psychiatric morbidity, handedness, or health related quality of life in adulthood. Obstetricians should continue to use a single course of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome.

MEMO--a mobile phone depression prevention intervention for adolescents: development process and postprogram findings on acceptability from a randomized controlled trial.

Background Prevention of the onset of depression in adolescence may prevent social dysfunction, teenage pregnancy, substance abuse, suicide, and mental health conditions in adulthood. New technologies allow delivery of prevention programs scalable to large and disparate populations. Objective To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents. We describe the development of the intervention and the results of participants’ self-reported satisfaction with the intervention. Methods The intervention was developed from 15 key messages derived from cognitive behavioral therapy (CBT). The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks, with a mixture of text, video, and cartoon messages and a mobile website. Delivery modalities were guided by social cognitive theory and marketing principles. The intervention was compared with an attention control program of the same number and types of messages on different topics. A double-blind randomized controlled trial was undertaken in high schools in Auckland, New Zealand, from June 2009 to April 2011. Results A total of 1348 students (13–17 years of age) volunteered to participate at group sessions in schools, and 855 were eventually randomly assigned to groups. Of these, 835 (97.7%) self-completed follow-up questionnaires at postprogram interviews on satisfaction, perceived usefulness, and adherence to the intervention. Over three-quarters of participants viewed at least half of the messages and 90.7% (379/418) in the intervention group reported they would refer the program to a friend. Intervention group participants said the intervention helped them to be more positive (279/418, 66.7%) and to get rid of negative thoughts (210/418, 50.2%)—significantly higher than proportions in the control group. Conclusions Key messages from CBT can be delivered by mobile phone, and young people report that these are helpful. Change in clinician-rated depression symptom scores from baseline to 12 months, yet to be completed, will provide evidence on the effectiveness of the intervention. If proven effective, this form of delivery may be useful in many countries lacking widespread mental health services but with extensive mobile phone coverage. ClinicalTrial Australia New Zealand Clinical Trials Registry (ACTRN): 12609000405213; http://www.anzctr.org.au/trial_view.aspx?ID=83667 (Archived by WebCite at http://www.webcitation.org/64aueRqOb)

Randomized clinical trial of honey-impregnated dressings for venous leg ulcers.

The efficacy of honey as a treatment for venous ulcers has not been evaluated, despite widespread interest. This trial aimed to evaluate the safety and effectiveness of honey as a dressing for venous ulcers.