scholarly journals Cigarette pack size and consumption: an adaptive randomised controlled trial

2021 ◽  
Author(s):  
Ilse Lee ◽  
Anna Katherine Mary Blackwell ◽  
Michelle Scollo ◽  
Katie De-loyde ◽  
Richard Morris ◽  
...  
Keyword(s):  
Experimental Evidence ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Pack Size ◽  
Sufficient Power ◽  
Cigarette Pack ◽  
Parallel Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Cigarette Packs

BackgroundObservational evidence suggests that cigarette pack size – the number of cigarettes in a single pack – is associated with consumption but experimental evidence of a causal relationship is lacking. The tobacco industry is introducing increasingly large packs, in the absence of maximum cigarette pack size regulation. In Australia, the minimum pack size is 20 but packs of up to 50 cigarettes are available. We aimed to estimate the impact on smoking of reducing cigarette pack sizes from ≥25 to 20 cigarettes per pack.Method A two-stage adaptive parallel group RCT in which Australian smokers who usually purchase packs containing ≥25 cigarettes were randomised to use only packs containing either 20 (intervention) or their usual packs (control) for four weeks. The primary outcome, the average number of cigarettes smoked per day, was measured through collecting all finished cigarette packs, labelled with the number of cigarettes participants smoked. An interim sample size re-estimation was used to evaluate the possibility of detecting a meaningful difference in the primary outcome. ResultsThe interim analysis, conducted when 124 participants had been randomised, suggested 1122 additional participants needed to be randomised for sufficient power to detect a meaningful effect. This exceeded pre-specified criteria for feasible recruitment, and data collection was terminated accordingly. Analysis of complete data (n=79) indicated that the mean cigarettes smoked per day was 15.9 (SD=8.5) in the intervention arm and 16.8 (SD=6.7) among controls (difference -0.9: 95%CI = -4.3, 2.6). ConclusionIt remains unclear whether reducing cigarette pack sizes from ≥25 to 20 cigarettes reduces cigarette consumption. The limitations identified in this study can inform a more efficient RCT, which is urgently required to address the dearth of experimental evidence on the impact of large cigarette pack sizes on smoking.

scholarly journals Cigarette pack size and consumption: an adaptive randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ilse Lee ◽  
Anna K. M. Blackwell ◽  
Michelle Scollo ◽  
Katie De-loyde ◽  
Richard W. Morris ◽  
...  
Keyword(s):  
Experimental Evidence ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Pack Size ◽  
Sufficient Power ◽  
Cigarette Pack ◽  
Parallel Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Cigarette Packs

Abstract Background Observational evidence suggests that cigarette pack size – the number of cigarettes in a single pack – is associated with consumption but experimental evidence of a causal relationship is lacking. The tobacco industry is introducing increasingly large packs, in the absence of maximum cigarette pack size regulation. In Australia, the minimum pack size is 20 but packs of up to 50 cigarettes are available. We aimed to estimate the impact on smoking of reducing cigarette pack sizes from ≥25 to 20 cigarettes per pack. Method A two-stage adaptive parallel group RCT in which Australian smokers who usually purchase packs containing ≥25 cigarettes were randomised to use only packs containing either 20 (intervention) or their usual packs (control) for four weeks. The primary outcome, the average number of cigarettes smoked per day, was measured through collecting all finished cigarette packs, labelled with the number of cigarettes participants smoked. An interim sample size re-estimation was used to evaluate the possibility of detecting a meaningful difference in the primary outcome. Results The interim analysis, conducted when 124 participants had been randomised, suggested 1122 additional participants needed to be randomised for sufficient power to detect a meaningful effect. This exceeded pre-specified criteria for feasible recruitment, and data collection was terminated accordingly. Analysis of complete data (n = 79) indicated that the mean cigarettes smoked per day was 15.9 (SD = 8.5) in the intervention arm and 16.8 (SD = 6.7) among controls (difference − 0.9: 95%CI = − 4.3, 2.6). Conclusion It remains unclear whether reducing cigarette pack sizes from ≥25 to 20 cigarettes reduces cigarette consumption. Importantly, the results of this study provide no evidence that capping cigarette pack sizes would be ineffective at reducing smoking. The limitations identified in this study can inform a more efficient RCT, which is urgently required to address the dearth of experimental evidence on the impact of large cigarette pack sizes on smoking. Trial registration 10.1186/ISRCTN34202533

scholarly journals A Randomised Controlled Trial of Pharmacist Medication Histories and Supplementary Prescribing on Medication Errors in Postoperative Medications

2011 ◽  
Vol 39 (6) ◽  
pp. 1064-1070 ◽  
Author(s):  
S. B. Marotti ◽  
R. K. Kerridge ◽  
M. D. Grimer
Keyword(s):  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
History Taking ◽  
Medication History ◽  
Parallel Group ◽  
Supplementary Prescribing ◽  
Randomised Controlled ◽  
The Impact ◽  
Parallel Group Trial

Errors in the management of regular medications at the time of hospital admission are common. This randomised controlled three-arm parallel-group trial examined the impact of pharmacist medication history taking and pharmacist supplementary prescribing on unintentional omissions of postoperative medications in a large perioperative service. Participants included elective surgical patients taking regular medications with a postoperative hospital stay of one night or more. Patients were randomly assigned, on admission, to usual care (n=120), a pharmacist medication history only (n=120) or pharmacist medication history and supplementary prescribing (n=120). A medication history involved the pharmacist interviewing the patient preoperatively and documenting a medication history in the medical record. In the supplementary prescribing group the patients’ regular medicines were also prescribed on the inpatient medication chart by the pharmacist, so that dosing could proceed as soon as possible after surgery without the need to wait for medical review. The estimate marginal mean number of missed doses during a patients hospital stay was 1.07 in the pharmacist supplementary prescribing group, which was significantly less than both the pharmacist history group (3.30) and the control group (3.21) (P <0.001). The number of medications charted at an incorrect dose or frequency was significantly reduced in the pharmacist history group and further reduced in the prescribing group (P <0.001). We conclude that many patients miss doses of regular medication during their hospital stay and preoperative medication history taking and supplementary prescribing by a pharmacist can reduce this.

Economic evaluation of a crisis resolution service: A randomised controlled trial

2009 ◽  
Vol 18 (1) ◽  
pp. 54-58 ◽  
Author(s):  
Paul McCrone ◽  
Sonia Johnson ◽  
Fiona Nolan ◽  
Stephen Pilling ◽  
Andrew Sandor ◽  
...  
Keyword(s):  
Mental Health ◽  
Service Use ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cost Effective ◽  
Primary Outcome Measure ◽  
Crisis Resolution ◽  
Randomised Controlled ◽  
The Impact

SummaryAims – The use of specialised services to avoid admission to hospital for people experiencing mental health crises is seen as an integral part of psychiatric services in some countries. The aim of this paper is to assess the impact on costs and costeffectiveness of a crisis resolution team (CRT). Methods – Patients who were experiencing mental health crises sufficient for admission to be considered were randomised to either care provided by a CRT or standard services. The primary outcome measure was inpatient days over a six-month follow-up period. Service use was measured, costs calculated and cost-effectiveness assessed. Results – Patients receiving care from the CRT had non-inpatient costs £768 higher than patients receiving standard care (90% CI, £153 to £1375). With the inclusion of inpatient costs the costs for the CRT group were £2438 lower for the CRT group (90% CI, £937 to £3922). If one less day spent as an inpatient was valued at £100, there would be a 99.5% likelihood of the CRT being costeffective. Conclusion – This CRT was shown to be cost-effective for modest values placed on reductions in inpatient stays.

scholarly journals Design and rationale of the MyHeartMate study: a randomised controlled trial of a game-based app to promote behaviour change in patients with cardiovascular disease

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024269 ◽  
Author(s):  
Robyn Gallagher ◽  
Clara Chow ◽  
Helen Parker ◽  
Lis Neubeck ◽  
David Celermajer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Prevention ◽  
Behaviour Change ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Mobile App ◽  
Lifestyle Changes ◽  
Local Health ◽  
Randomised Controlled ◽  
The Impact

IntroductionRecurrence of cardiac events is common after a first event, leading to hospitalisations and increased health burden. Patients have difficulties achieving the lifestyle changes required for secondary prevention and access to secondary prevention programs is limited. This study aims to evaluate the impact of a game-based mobile app, MyHeartMate, which is designed to motivate engagement in secondary prevention behaviours for cardiovascular risk factors.Methods and analysisThe MyHeartMate study is a randomised controlled trial with 6-month follow-up and blinded assessment of the primary outcome. Participants (n=394) with coronary heart disease will be recruited from hospitals in metropolitan Sydney and randomly allocated to standard care or the MyHeartMate app intervention. The intervention group will receive the app, which uses game techniques to promote engagement and lifestyle behaviour change for secondary prevention. The primary outcome is difference between the groups in physical activity (metabolic equivalent of task minutes/week) at 6 months. Secondary outcomes include change in low-density lipoprotein cholesterol, systolic blood pressure, medication adherence, body mass index, waist circumference, mood and dietary changes at 6 months. Data on app engagement, and patient perspectives of usability and acceptability, will also be analysed.Ethics and disseminationThe study has received ethics approval from Northern Sydney Local Health District Human Research Ethics Committee. The study findings will be disseminated via peer-reviewed publications and presentation at international scientific meetings/conferences.Trial registration numberACTRN12617000869370; Pre-results.

scholarly journals Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024256 ◽  
Author(s):  
Elizabeth G Ryan ◽  
Ewen M Harrison ◽  
Rupert M Pearse ◽  
Simon Gates
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gastrointestinal Surgery ◽  
Evidence Based ◽  
Bayesian Analyses ◽  
Therapy Algorithm ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

ObjectiveThe traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.Design, setting, participants and interventionsThe OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.MethodsWe repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.ResultsAlthough OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.ConclusionsThe use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.Trial registration numberISRCTN04386758; Post-results.

Promoting physical activity through group self-management support for those with multimorbidity: a randomised controlled trial

2021 ◽  
pp. BJGP.2021.0172
Author(s):  
Kamlesh Khunti ◽  
Patrick James Highton ◽  
Ghazala Waheed ◽  
Helen Dallosso ◽  
Emma Redman ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Management ◽  
Activity Levels ◽  
Activity Promotion ◽  
Physical Activity Levels ◽  
Randomised Controlled ◽  
The Impact

Background: Targeted self-management programmes may improve health and increase physical activity in people with multimorbidity. Aim: Investigate the impact of a structured, theoretically-driven self-management group education programme on habitual physical activity levels in people with multimorbidity. Design: Individually randomised controlled trial with 12-month follow-up. Setting: Nine primary care practices within Leicestershire, UK. Methods: N=353 adults with multimorbidity (age 67.8±9 years, 161 male) were randomly assigned (1:1) to intervention (n=180) or control (n=173) groups. Intervention participants were invited to attend four group-based self-management sessions, centred primarily on increasing physical activity. They also received motivational text message support. The primary outcome measure was change from baseline in device-measured (GENEActiv wrist-worn accelerometer) overall volume of daily physical activity at 12 months. Results: At baseline, the total sample was achieving 22mins/day of moderate-to-vigorous intensity physical activity. At 12 months a reduction in daily average physical activity was seen in the intervention group relative to control participants in the complete-case analysis (-0.80 mg; 95% CI: -1.57, -0.03; p=0.04) (primary outcome data available for 71.1% and 79.2% of intervention and control groups respectively). Similar reductions were seen in time spent in moderate-to-vigorous physical activity (-3.86 mins/day; 95% CI:-6.70, -1.03; p=0.01) and time spent at an intensity equivalent to a slow walk (-4.66 mins/day; 95% CI: -8.82, -0.51; p=0.028). Conclusions: The self-management programme elicited a slight reduction in physical activity levels in people with multimorbidity. Future studies should identify and target subgroups of those with multimorbidity at greatest need for physical activity promotion.

scholarly journals The HELPER programme: HEalthy Living and Prevention of Early Relapse – three exploratory randomised controlled trials of phase-specific interventions in first-episode psychosis

2015 ◽  
Vol 3 (2) ◽  
pp. 1-238 ◽  
Author(s):  
Max Marshall ◽  
Christine Barrowclough ◽  
Richard Drake ◽  
Nusrat Husain ◽  
Fiona Lobban ◽  
...  
Keyword(s):  
Early Intervention ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Psychotic Symptoms ◽  
First Episode ◽  
Controlled Trials ◽  
Early Intervention Services ◽  
Sufficient Power ◽  
Randomised Controlled ◽  
The Impact

BackgroundSchizophrenia represents a substantial cost to the NHS and society because it is common (lifetime prevalence around 0.5–1%); it begins in adolescence or early adulthood and often causes lifelong impairment. The first 3 years are a ‘critical period’ in which the course of the illness is determined. Hence under the NHS Plan, specialist early intervention in psychosis services were established to care for people who develop psychosis between the ages of 14 and 35 years for the first 3 years of their illness. However, there has been a lack of evidence-based treatments specifically designed for the early years. This is important because emerging evidence has shown that in the critical period it is vital to avoid relapse and prevent deterioration in physical health, as both can drastically reduce the chances of a full recovery.ObjectivesTo develop and evaluate three phase-specific interventions to prevent relapse and/or deterioration in physical health in people with first-episode psychosis. The interventions were (1) cognitive remediation (CR) to improve meta-cognition and insight and enhance engagement in cognitive therapy [evaluated in the IMproving PArticipation in Cognitive Therapy (IMPACT) trial]; (2) a healthy-living intervention to control weight in people taking antipsychotic medication after a first episode of psychosis [evaluated in the INTERvention to Encourage ACTivity, Improve Diet, and Reduce Weight Gain (InterACT trial)]; and (3) integrated motivational interviewing and cognitive–behavioural therapy (MiCBT) to reduce cannabis use [evaluated in the Rethinking Choices After Psychosis (ReCAP) trial]. The trials were conducted to explore the case for larger definitive trials with relapse as a primary outcome measure. However, as small trials do not have sufficient power to detect significant reductions in relapse, each was focused on a relevant primary outcome for which there was sufficient power to detect a significant difference. In all three trials relapse was a secondary outcome in the hope of detecting trends towards lower relapse rates in the presence of effective interventions or a general trend across all three studies towards lower relapse rates.DesignThree exploratory randomised controlled trials (RCTs) accompanied by qualitative work employing grounded theory and framework analysis to inform the interventions and determine acceptability (InterACT and ReCAP trials).SettingFive early-intervention services in the north-west of England.ParticipantsEarly-intervention service users aged 16–35 years who had recently experienced a first episode of psychosis. Participants in the IMPACT trial were drawn from a waiting list of people referred for routine CBT; those in the InterACT trial were required to have a body mass index (BMI) of ≥ 25 kg/m2(or ≥ 24 kg/m2for service users from the South Asian community); and those in the ReCAP trial metDiagnostic and Statistical Manual of Mental Disorders– Fourth Edition (DSM-IV) criteria for cannabis abuse or dependence.InterventionsThe IMPACT trial involved 13 sessions of CR over 12 weeks; the InterACT trial involved eight face-to-face sessions plus optional group activities over 12 months; and the ReCAP trial involved MiCBT in brief (12 sessions over 4.5 months) and long (24 sessions over 9 months) forms.Main outcome measuresThe primary outcome in the IMPACT trial was psychotic symptoms assessed by the Psychotic Symptom Rating Scales (PSYRATS). BMI was the primary outcome in the InterACT trial and cannabis use (measured by timeline follow-back) was the primary outcome in the ReCAP trial. Relapse was a secondary outcome across all three trials.ResultsIn the IMPACT trial there was no beneficial effect of CR on psychotic symptoms; however, the amount of CBT required was significantly less after CR. In the InterACT trial a small reduction in BMI in the intervention group was not statistically significant. For participants taking olanzapine or clozapine the effect size was larger although not significant. Outcome data from the ReCAP trial are not yet available. Retention in all three trials was good, indicating that the interventions were acceptable.ConclusionsEarly-intervention services provided a good setting to conduct trials. The IMPACT trial found that CR delivered by relatively unskilled workers improved the efficiency of subsequent CBT. Across the three trials there was little evidence that any intervention reduced relapse.Trial registrationCurrent Controlled Trials ISRCTN17160673 (IMPACT); Current Controlled Trials ISRCTN22581937 (InterACT); Current Controlled Trials ISRCTN88275061 (ReCAP).FundingThis project was funded by the NIHR Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 3, No. 2. See the NIHR Journals Library website for further project information.

scholarly journals Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial

Thorax ◽  
2017 ◽  
Vol 73 (3) ◽  
pp. 213-221 ◽  
Author(s):  
Stephen E Wright ◽  
Kirsty Thomas ◽  
Gillian Watson ◽  
Catherine Baker ◽  
Andrew Bryant ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outcome Data ◽  
Physical Rehabilitation ◽  
Control Group ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Lost To Follow Up

BackgroundEarly physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known.MethodsWe conducted a randomised, parallel-group, allocation-concealed, assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months.ResultsWe recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67–273) min of physical rehabilitation on ICU compared with 86 (31–139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group.ConclusionsIn this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation.Trial registration numberISRCTN 20436833.

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