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Introduction Exposure to secondhand smoke (SHS) risks children's health. However, biomarkers are rarely used to study SHS exposure among children in low- and middle-income countries. Aims and Methods We analyzed cross-sectional data collected between March and November 2022 for a cluster-randomized controlled trial investigating a Smoke-Free Intervention in 2769 children aged 9–15 in 74 schools (34 in Dhaka, Bangladesh, and 40 in Karachi, Pakistan). Children's saliva was tested for the concentration of cotinine—a highly sensitive and specific biomarker for SHS exposure. Based on their reports, children's homes were categorized as Nonsmoking Homes (NSH) when residents were nonsmokers; Smoke-free Homes (SFH) when residents and visitors smoked outdoors only; and Smoke-permitted Homes (SPH) when either residents or visitors smoked indoors. We compared cotinine concentrations across these home types and the two cities using a proportional odds model. Results Overall, 95.7% of children (92% in Dhaka; and 99.4% in Karachi) had cotinine levels between 0.1 and 12 ng/mL, indicating SHS exposure. Median cotinine levels were higher in Karachi (0.58 ng/mL, IQR 0.37 to 0.93) than in Dhaka (0.27 ng/mL, IQR 0.16 to 0.49). Median cotinine concentration was also higher among children living in SPH than those in either NSH or SFH; with absolute differences of approximately 0.1–0.3 and 0.05 ng/mL, respectively. Conclusions The level of SHS exposure in Dhaka and Karachi indicates widespread and unrestricted smoking. Smoking restrictions in households and enforcement of smoking bans are urgently needed. Implications The high levels of SHS exposure in children living in SFH suggest parental behavior to hide their smoking and/or exposure in private vehicles or public spaces. It is important to advocate for SFH and cars to protect children from SHS exposure. However, these initiatives alone may not be enough. There is a need to enforce smoking bans in enclosed public places and transportation, as well as extend these bans to playgrounds, parks, fairgrounds, and other public spaces that children frequently visit. It is essential to complement smoking restrictions with tobacco cessation advice and support in these settings. [ABSTRACT FROM AUTHOR]

Background: There is increasing interest in the capacity of adaptive designs to improve the efficiency of clinical trials. However, relatively little work has investigated how economic considerations – including the costs of the trial – might inform the design and conduct of adaptive clinical trials. Methods: We apply a recently published Bayesian model of a value-based sequential clinical trial to data from the 'Hydroxychloroquine Effectiveness in Reducing symptoms of hand Osteoarthritis' (HERO) trial. Using parameters estimated from the trial data, including the cost of running the trial, and using multiple imputation to estimate the accumulating cost-effectiveness signal in the presence of missing data, we assess when the trial would have stopped had the value-based model been used. We used re-sampling methods to compare the design's operating characteristics with those of a conventional fixed length design. Results: In contrast to the findings of the only other published retrospective application of this model, the equivocal nature of the cost-effectiveness signal from the HERO trial means that the design would have stopped the trial close to, or at, its maximum planned sample size, with limited additional value delivered via savings in research expenditure. Conclusion: Evidence from the two retrospective applications of this design suggests that, when the cost-effectiveness signal in a clinical trial is unambiguous, the Bayesian value-adaptive design can stop the trial before it reaches its maximum sample size, potentially saving research costs when compared with the alternative fixed sample size design. However, when the cost-effectiveness signal is equivocal, the design is expected to run to, or close to, the maximum sample size and deliver limited savings in research costs. [ABSTRACT FROM AUTHOR]

Aims: To test the efficacy of 'MiQuit', a tailored, self‐help, text message stop smoking programme for pregnancy, as an adjunct to usual care (UC) for smoking cessation in pregnancy. Design Multicentre, open, two‐arm, parallel‐group, superiority randomised controlled trial (RCT) and a trial sequential analysis (TSA) meta‐analysis combining trial findings with two previous ones. Setting: Twenty‐four English hospital antenatal clinics. Participants: A total of 1002 pregnant women who were ≥16 years old, were ≤25 weeks gestation and smoked ≥1 daily cigarette and accepted information on cessation with no requirement to set quit dates. Interventions: UC or UC plus 'MiQuit': 12 weeks of tailored, smoking cessation text messages focussed on inducing and aiding cessation. Measurements Primary outcome: biochemically validated cessation between 4 weeks after randomisation and late pregnancy. Secondary outcomes: shorter and non‐validated abstinence periods, pregnancy outcomes and incremental cost‐effectiveness ratios. Findings RCT: cessation was 5.19% (26/501) and 4.59% (23/501) in MiQuit and UC groups (adjusted odds ratio [adj OR] for quitting with MiQuit versus UC, 95% CI = 1.15 [0.65–2.04]); other abstinence findings were similar, with higher point estimates. Primary outcome ascertainment was 61.7% (309) and 67.3% (337) in MiQuit and UC groups with 71.1% (54/76) and 69.5% (41/59) abstinence validation rates, respectively. Pregnancy outcomes were similar and the incremental cost per quality‐adjusted life year was −£1118 (95% CI = −£4806–£1911). More MiQuit group women reported making at least one quit attempt (adj OR [95% CI]) for making an attempt, 1.50 (1.07–2.09). TSA meta‐analysis: this found no significant difference in prolonged abstinence between MiQuit and UC (pooled OR = 1.49, adjusted 95% CI = 0.62–3.60). Conclusions: Irrespective of whether they want to try quitting, when offered a tailored, self‐help, text message stop smoking programme for pregnancy (MiQuit) as an adjunct to usual care, pregnant women are not more likely to stop smoking until childbirth but they report more attempts at stopping smoking. [ABSTRACT FROM AUTHOR]

Animals of the rainforest canopies are often endangered by deforestation or hunting but are difficult to survey and study because of the inaccessibility of the treetops, combined with the visual camouflage of many species. Drone-based thermal sensors have the potential to overcome these hurdles by rapidly scanning large forested areas from above, detecting and mapping wildlife based on the contrast between their warm body temperatures and the cool tree canopies. We tested this concept by flying a drone-mounted thermal infrared radiometric sensor over the wildlife-rich rainforests of Barro Colorado Island, Panama. Arboreal mammals had body temperatures around 27°C and were conspicuous in the thermal infrared imagery at night and early morning when the forest canopy was cool (23-25°C), but were difficult to detect by mid-morning, by which time the direct sunshine had heated up canopy vegetation to over 30°C. Species were difficult to identify from thermal infrared imagery alone, but could be recognized from synchronized visual images taken during the daytime. Simultaneous drone and ground-based surveys of the same area proved that the aerial thermal camera did detect high-canopy species missed by the terrestrial observer, but that substantially more animals were detected by the human than by the drone. Because animal detection was so much better at night, when species ID was difficult, we suggest that future work could combine automated detection of animals from thermal infrared imagery with flash photography or IR illumination to enable species ID during nocturnal surveys. We conclude by discussing various logistical challenges that limit the utility of drone-based thermal infrared today, but that could be overcome by continued improvement of technology and collaboration with permitting agencies. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Autistic children can experience mental health, social and emotional difficulties. Carol Gray's Social Stories™ are a highly personalised intervention that provide social information in a short individually tailored story.A multi‐site pragmatic cluster randomised controlled trial to evaluate the clinical and cost‐effectiveness of Social Stories™ alongside care as usual in autistic children aged 4–11 years. The primary outcome was the Social Responsiveness Scale‐2 completed by teachers 6 months post‐randomisation, analysed on an intention‐to‐treat basis. Trial Registration: ISRCTN11634810.Eighty‐seven schools, including 249 children, were randomised (intervention 44 schools with 129 children, and usual care 43 schools with 120 children). After 6 months, a reduction of 1.61 points was found on the Social Responsiveness Scale‐2 in the intervention group (95% CI −4.18 to 0.96, p = .220) and for those who attended at least six sessions a reduction of 3.37 points (CACE 95% CI −6.65 to −0.10, p = .043). Children in the intervention group met their individual socio‐emotional goal more frequently than children receiving usual care alone and this was statistically significant. No statistically significant differences were found in other secondary outcomes including anxiety, depression, general health or parental stress.Social Stories™ represent a low‐cost, low‐burden intervention. Benefits are seen in individual socio‐emotional goals but without clinically evident impact on social responsiveness, anxiety, depression, parental stress or general health. [ABSTRACT FROM AUTHOR]

BACKGROUND Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited. METHODS We performed an unblinded, multicenter, pragmatic, two-group, randomized, controlled noninferiority trial comparing collagenase injection with limited fasciectomy in persons with moderate Dupuytren's contracture. The primary outcome was the score on the Patient Evaluation Measure-Hand Health Profile (PEM), questionnaire for assessing hand health as reported by the patient, at 1 year after treatment. Scores on the PEI\4 range from 0 to 100, with higher scores indicating worse outcomes. The prespecified noninferiority margin was 6 points. RESULTS A total of 672 persons (336 per group) were assigned to receive collagenase injection or to undergo limited fasciectomy. The primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. The mean score on the PEM at lyear was 17.8 among the 284 patients with available data the collagenase group and 11.9 among the 250 patients with available data in the limited-fasciectomy group (estimated difference, 5.9 points; 95°/o confidence interval ICI], 3.l to 8.8; one-sided P=0.49 for noninferiority). Among the patients with available data (229 patients in the collagenase group and 197 patients in the limited-fasciectomy group), the estimated difference in the mean score on the PEM at 2 years was 7. 2 points (95% CI, 4.2 to 10.9). Moderate or severe complications of treatment occurred in 1.8% of the patients in the collagenase group and in 5.1° of those in the limited-fasciectomy group; recurrent contracture resulted in reintervention in 14.6% and 3.4%, respectively. CONCLUSIONS Collagenase injection was not noninferior to limited fasciectomy with respect the score on the PEM at 1 year after treatment. [ABSTRACT FROM AUTHOR]

Introduction: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation., Methods and Analysis: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness., Ethics and Dissemination: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants., Trial Registration Number: ISRCTN16830506., Protocol Version: 5.0, 10 Oct 2023., Competing Interests: Competing interests: FN is an unpaid member of the scientific committee for the Smoke Free app, a smoking cessation app unrelated to this project. All other authors have declared that they have no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Secondhand smoke (SHS) exposure is a major cause of premature death and disease, especially among children. Children in economically developing countries are particularly affected as smoke-free laws are typically only partially implemented and private homes and cars remain a key source of SHS exposure. Currently, firm conclusions cannot be drawn from the available evidence on the effectiveness of non-legislative interventions designed to protect children from SHS exposure. Following the success of two feasibility studies and a pilot trial, we plan to evaluate a school-based approach to protect children from SHS exposure in Bangladesh and Pakistan-countries with a strong commitment to smoke-free environments but with high levels of SHS exposure in children. We will conduct a two-arm cluster randomised controlled trial in Bangladesh and Pakistan to assess the effectiveness and cost effectiveness of a school-based smoke-free intervention (SFI) in reducing children's exposure to SHS and the frequency and severity of respiratory symptoms., Methods and Analysis: We plan to recruit 68 randomly selected schools from two cities-Dhaka in Bangladesh and Karachi in Pakistan. From each school, we will recruit approximately 40 students in a year (9-12 years old) with a total of 2720 children. Half of the schools will be randomly allocated to the intervention arm receiving SFI and the other half will receive usual education. Salivary cotinine concentration-a highly sensitive and specific biomarker of SHS exposure-is the primary outcome, which will be measured at month 3 post-randomisation. Secondary outcomes will include frequency and severity of respiratory symptoms, healthcare contacts, school absenteeism, smoking uptake and quality of life. Embedded economic and process evaluations will also be conducted., Ethics and Dissemination: The trial has received ethics approval from the Research Governance Committee at the University of York. Approvals have also been obtained from Bangladesh Medical Research Council and Pakistan Health Research Council. If SFI is found effective, we will use a variety of channels to share our findings with both academic and non-academic audiences. We will work with the education departments in Bangladesh and Pakistan and advocate for including SFI within the curriculum., Trial Registration Number: ISRCTN28878365., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: RCTs often face issues such as slow recruitment, poor intervention adherence and high attrition, however the 2020/2021 COVID-19 pandemic intensified these challenges. Strategies employed by the DISC trial to overcome pandemic-related barriers to recruitment, treatment delivery and retention may be useful to help overcome routine problems., Methods: A structured survey and teleconference with sites was undertaken. Key performance indicators in relation to recruitment, treatment delivery and retention were compared descriptively before and after the pandemic started. This was situated also in relation to qualitative opinions of research staff., Results: Prior to the pandemic, retention was 93.6%. Increased support from the central trial management team and remote data collection methods kept retention rates high at 81.2% in the first 6 months of the pandemic, rising to 89.8% in the subsequent 6 months. Advertising the study to patients resulted in 12.8 patients/month enquiring about participation, however only six were referred to recruiting sites. Sites reported increased support from junior doctors resolved research nurse capacity issues. One site avoided long delays by using theatre space in a private hospital., Conclusions: Recruitment post-pandemic could be improved by identification of barriers, increased support from junior doctors through the NIHR associate PI scheme and advertising. Remote back-up options for data collection can keep retention high while reducing patient and site burden. To future proof studies against similar disruptions and provide more flexibility for participants, we recommend that RCTs have a back-up option of remote recruitment, a back-up location for surgeries and flexible approaches to collecting data., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Aims: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures., Methods: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods., Discussion: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open  2021;2(3):150-163.

Background : Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods : A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results : A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions : Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration : ISRCTN22202133; SWAT 35., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Cochrane A et al.)