Immediate smoking cessation support during lung cancer screening: long-term outcomes from two randomised controlled trials.

BACKGROUND: Immediate smoking cessation interventions delivered alongside targeted lung health checks (TLHCs) to screen for lung cancer increase self-reported abstinence at 3 months. The impact on longer term, objectively confirmed quit rates remains to be established. METHODS: We followed up participants from two clinical trials in people aged 55-75 years who smoked and took part in a TLHC. These randomised participants in the TLHC by day of attendance to either usual care (UC) (signposting to smoking cessation services) or an offer of immediate smoking cessation support including pharmacotherapy. In the QuLIT1 trial, this was delivered face to face and in QuLIT2, it was delivered remotely. Follow-up was conducted 12 months after the TLHC by telephone interview with subsequent biochemical verification of smoking cessation using exhaled CO. RESULTS: 430 people were enrolled initially (115 in QuLIT1 and 315 in QuLIT2), with 4 deaths before 12 months leaving 426 (62.1±5.27 years old and 48% women) participants for analysis. At 12 months, those randomised to attend on smoking cessation support intervention days had higher quit rates compared with UC adjusted for age, gender, deprivation, and which trial they had been in; self-reported 7-day point prevalence (20.0% vs 12.8%; adjusted OR (AOR)=1.78; 95% CI 1.04 to 2.89) and CO-verified quits (12.1% vs 4.7%; AOR=2.97; 95% CI 1.38 to 6.90). Those in the intervention arm were also more likely to report having made a quit attempt (30.2% vs UC 18.5%; AOR 1.90; 95% CI 1.15 to 3.15). CONCLUSION: Providing immediate smoking cessation support alongside TLHC increases long term, biochemically confirmed smoking abstinence. TRIAL REGISTRATION NUMBER: ISRCTN12455871.

Strategies to deliver smoking cessation interventions during targeted lung health screening - a systematic review and meta-analysis.

INTRODUCTION: Lung cancer screening presents an important teachable moment to promote smoking cessation, but the most effective strategy to deliver support in this context remains to be established. METHODS: We undertook a systematic review and meta-analysis of smoking cessation interventions delivered during lung health screening, published prior to 20/07/2022 MEDLINE, PsychINFO, CENTRAL, EMBASE, CINAHL and Scopus databases. Two reviewers screened titles, and abstracts, four reviewed each full text using prespecified criteria, extracted relevant data, assessed risk of bias and confidence in findings using the GRADE criteria. The review was registered prospectively on PROSPERO (CRD42021242431). RESULTS: 10 randomised controlled trials and three observational studies with a control group were identified. Meta-analysis of nine RCTs demonstrated that smoking cessation interventions delivered during lung screening programmes increased quit rates compared to usual care (odds ratios: 2.01, 95%: 1.49-2.72 p < 0.001). Six RCTs using intensive (≥3 behavioural counselling sessions) interventions demonstrated greater quit rates compared to usual care (OR: 2.11, 95% CI 1.53-2.90, p < 0.001). A meta-analysis of two RCTs found intensive interventions were more effective than non-intensive (OR: 2.07, 95%CI 1.26-3.40 p = 0.004), Meta-analysis of two RCTs of non-intensive interventions (≤2 behavioural counselling sessions or limited to online information audio take home materials such as pamphlets) did not show a higher quit rate than usual care (OR: 0.90, 95% CI 0.39-2.08 p = 0.80). DISCUSSION: Moderate quality evidence supports smoking cessation interventions delivered within a lung screening setting compared to usual care, with high-quality evidence that more intensive interventions are likely to be most effective.

What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials.

BACKGROUND: Clinical trials are fundamental to healthcare, however, they also contribute to anthropogenic climate change. Following previous work to develop and test a method and guidance to calculate the carbon footprint of clinical trials, we have now applied the guidance to 10 further UK and international, academically sponsored clinical trials to continue the identification of hotspots and opportunities for lower carbon trial design. METHODS: 10 collaborating clinical trial units (CTUs) self-identified and a trial was selected from their portfolio to represent a variety of designs, health areas and interventions. Trial activity data was collated by trial teams across 10 modules spanning trial setup through to closure, then multiplied by emission factors provided in the guidance to calculate the carbon footprint. Feedback was collected from trial teams on the process, experience and ease of use of the guidance. RESULTS: We footprinted 10 trials: 6 investigational medicinal product trials, 1 nutritional, 1 surgical, 1 health surveillance and one complex intervention trial. Six of these were completed and four ongoing (two in follow-up and two recruiting). The carbon footprint of the 10 trials ranged from 16 to 765 tonnes CO2e. Common hotspots were identified as CTU emissions, trial-specific patient assessments and trial team meetings and travel. Hotspots for specific trial designs were also identified. The time taken to collate activity data and complete carbon calculations ranged from 5 to 60 hours. The draft guidance was updated to include new activities identified from the 10 trials and in response to user feedback. DISCUSSION: There are opportunities to reduce the impact of trials across all modules, particularly trial-specific meetings and travel, patient assessments and laboratory practice. A trial's carbon footprint should be considered at the design stage, but work is required to make this common place.

Singing for lung health in COPD: a multicentre randomised controlled trial of online delivery.

BACKGROUND: Singing for lung health (SLH) is an arts-based breathing control and movement intervention for people with long-term respiratory conditions, intended to improve symptoms and quality of life. Online, remotely delivered programmes might improve accessibility; however, no previous studies have assessed the effectiveness of this approach. METHODS: We conducted an assessor-blind randomised controlled trial comparing the impact of 12 weeks of once-weekly online SLH sessions against usual care on health-related quality of life, assessed using the RAND 36-Item Short Form Health Survey (SF-36) Mental Health Composite (MHC) and Physical Health Composite (PHC) scores. RESULTS: We enrolled 115 people with stable chronic obstructive pulmonary disease (COPD), median (IQR) age 69 (62-74), 56.5% females, 80% prior pulmonary rehabilitation, Medical Research Council dyspnoea scale 4 (3-4), forced expiratory volume in 1 s % predicted 49 (35-63). 50 participants in each arm completed the study. The intervention arm experienced improvements in physical but not mental health components of RAND SF-36; PHC (regression coefficient (95% CI): 1.77 (95% CI 0.11 to 3.44); p=0.037), but not MHC (0.86 (95% CI -1.68 to 3.40); p=0.504). A prespecified responder analysis based on achieving a 10% improvement from baseline demonstrated a response rate for PHC of 32% in the SLH arm and 12.7% for usual care (p=0.024). A between-group difference in responder rate was not found in relation to the MHC (19.3% vs 25.9%; p=0.403). DISCUSSION AND CONCLUSION: A 12-week online SLH programme can improve the physical component of quality of life for people with COPD, but the overall effect is relatively modest compared with the impact seen in research using face-to-face group sessions. Further work on the content, duration and dose of online interventions may be useful. TRIAL REGISTRATION NUMBER: NCT04034212.

Investigating the prognostic value of digital mobility outcomes in patients with chronic obstructive pulmonary disease: a systematic literature review and meta-analysis.

BACKGROUND: Reduced mobility is a central feature of COPD. Assessment of mobility outcomes that can be measured digitally (digital mobility outcomes (DMOs)) in daily life such as gait speed and steps per day is increasingly possible using devices such as pedometers and accelerometers, but the predictive value of these measures remains unclear in relation to key outcomes such as hospital admission and survival. METHODS: We conducted a systematic review, nested within a larger scoping review by the MOBILISE-D consortium, addressing DMOs in a range of chronic conditions. Qualitative and quantitative analysis considering steps per day and gait speed and their association with clinical outcomes in COPD patients was performed. RESULTS: 21 studies (6076 participants) were included. Nine studies evaluated steps per day and 11 evaluated a measure reflecting gait speed in daily life. Negative associations were demonstrated between mortality risk and steps per day (per 1000 steps) (hazard ratio (HR) 0.81, 95% CI 0.75-0.88, p<0.001), gait speed (<0.80 m·s-1) (HR 3.55, 95% CI 1.72-7.36, p<0.001) and gait speed (per 1.0 m·s-1) (HR 7.55, 95% CI 1.11-51.3, p=0.04). Fewer steps per day (per 1000) and slow gait speed (<0.80 m·s-1) were also associated with increased healthcare utilisation (HR 0.80, 95% CI 0.72-0.88, p<0.001; OR 3.36, 95% CI 1.42-7.94, p=0.01, respectively). Available evidence was of low-moderate quality with few studies eligible for meta-analysis. CONCLUSION: Daily step count and gait speed are negatively associated with mortality risk and other important outcomes in people with COPD and therefore may have value as prognostic indicators in clinical trials, but the quantity and quality of evidence is limited. Larger studies with consistent methodologies are called for.

Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream.

BACKGROUND: Topical coal tar is a well known and effective treatment for psoriasis, but the messiness, staining, odor, and inconvenience associated with its use make patient satisfaction and compliance a challenge. OBJECTIVE: To determine the efficacy, patient tolerability, and cosmetic acceptability of a new topical liquor carbonis distillate (LCD) 15% solution compared with calcipotriene (calcipotriol) cream in patients with moderate, chronic plaque psoriasis. STUDY DESIGN: A randomized, single-blind, active-controlled, parallel-group, clinical trial consisting of a 12-week treatment phase and a 6-week post-treatment follow-up phase. SETTING: Outpatient dermatology research unit in an academic hospital. PATIENTS: Sixty adults with moderate, chronic plaque psoriasis (3-15% body surface area affected) not receiving other psoriasis therapies. INTERVENTION: Patients were randomized to apply either an LCD 15% solution (Psorent) or a commercially available calcipotriene 0.005% cream (Dovonex) to their psoriasis areas (excluding the head) twice daily at home for 12 weeks. ASSESSMENTS: A blinded investigator evaluated the patients' psoriasis using a modified Psoriasis Area and Severity Index (PASI) that excluded the head, and a Physician's Global Assessment (PGA) scale at weeks 0 (baseline), 2, 4, 8, and 12 (end of treatment), and 18 (6 weeks after treatment was withdrawn). Patients assessed their psoriasis symptoms and quality of life and completed a cosmetic acceptability survey about their medication. OUTCOME MEASURES: The changes in the baseline PASI scores after 12 weeks of treatment were compared between LCD and calcipotriene groups. Additional comparisons were performed for success rates during treatment (PASI 75 and PASI 50), changes in PGA scores, patient-reported psoriasis symptom scores, patients' quality-of-life scores, and recurrence rates during post-treatment follow-up. RESULTS: Both treatment groups showed improvement in psoriasis severity and quality of life. However, the LCD group had greater mean reductions in PASI scores: 58% vs 37% in the calcipotriene group (p < 0.05) at week 12. Additionally, the LCD group had more patients (14/27) with absent or minimal psoriasis on the PGA scale than the calcipotriene group (6/28) by the end of treatment (p < 0.05). LCD-treated patients also maintained their improvement better than calcipotriene-treated patients through week 18 after treatment was withdrawn for 6 weeks. Both treatments were well tolerated and cosmetically acceptable to patients. CONCLUSION: The newly formulated LCD solution, applied twice daily at home for 12 weeks, was more effective and as well tolerated and cosmetically acceptable as the calcipotriene cream over 12 weeks of treatment and 6 weeks of follow-up. The LCD solution is a patient-accepted and effective corticosteroid-sparing treatment alternative for psoriasis patients.

Reporting of ethical review of clinical research submitted to the Journal of the American Academy of Dermatology.

BACKGROUND: In recent years there has been an increasing focus on human subject protection and on documentation of ethical review in published clinical research. The JAAD clearly states in its instructions to authors, which adhere to the guidelines set forth by the International Committee of Medical Journal Editors, "studies involving live human subjects must have been approved by the author's Institutional Review Board or its equivalent." OBJECTIVE: To determine what proportion of prospective studies on human subjects submitted to the clinical trials and therapeutics section lacked mention of review by an ethics board and to determine the outcome of these manuscripts. METHODS: We reviewed 150 prospective studies submitted from July 1, 2004 to January 16, 2006 to a single associate editor, who receives the majority of reports requiring ethics board review. RESULTS: Of 150 prospective studies, 36% (n = 54) had no mention of ethics review or consent, whereas 15% (n = 22) mentioned consent but not ethics review. Forty-two papers were returned asking for ethics information, and of these, 48% were resubmitted with confirmation of ethics review, 22% were withdrawn, 12% were never resubmitted, 12% responded that ethical review was not obtained, and 7% were clarified as exempt from review. Of the 150 papers, 45% were from US authors and 55% were from international authors. Sixty-seven percent of US papers and 35% of international papers included ethics board information (P

Age-related differences in brain activation during emotional face processing.

Advancing age is associated with significant declines on neurobehavioral tasks that demand substantial mental effort. Functional imaging studies of mental abilities indicate that older adults faced with cognitive challenges tend to activate more regions, particularly frontal, than their younger counterparts, and that this recruitment of additional regions may reflect an attempt to compensate for inefficiency in cortical networks. The neural basis of emotion processing in aging has received little attention, and the goal of the present study was to use functional magnetic resonance imaging (fMRI) to examine the influence of age on facial emotion processing and activation in cortical and limbic regions. Participants (eight old and eight young adults) viewed facial displays of happiness, sadness, anger, fear, disgust, and neutrality in alternating blocks of emotion and age discrimination. We predicted that in response to an emotion discrimination task, older adults would demonstrate increased use of frontal regions relative to younger adults, perhaps combined with diminished use of regions recruited by younger adults, such as temporo-limbic regions. During the emotion discrimination task, young participants activated, visual, frontal and limbic regions, whereas older participants activated parietal, temporal and frontal regions. A direct comparison between emotion and age discrimination revealed that while younger adults activated the amygdala and surrounding temporo-limbic regions, older adults activated left frontal regions. The results of this study suggest that older adults may rely on different cortical networks to perceive emotional facial expressions than do their younger counterparts.

Race, rather than skin pigmentation, predicts facial hair growth in women.

BACKGROUND: The Ferriman-Gallwey hirsutism score is the currently accepted standard for assessing excess hair growth that may indicate hyperandrogenicity. The score was originally based on 60 Caucasian women, and recent studies suggest that it may need modification to be used in other populations. OBJECTIVES: To investigate ethnic, racial, and pigmentary variations in hair growth of the upper lip in diverse multinational populations. RESULTS: Variations in hair growth of the upper lip were significantly related to self-reported ethnicity and race. In a logistic regression with racial groups and skin lightness, all racial groupings (African American, Hispanic, Asian Indian, and East Asian) were predictive of hair growth (all p<0.0001), but skin lightness was not (all p>0.05). CONCLUSION: The observed differences in constitutive hair growth illustrate the need to develop an ethnically stratified visual scoring method to more accurately characterize the severity of excess hair growth.

Acne vulgaris in women: prevalence across the life span.

BACKGROUND: Acne vulgaris is a common skin disease with a large quality of life impact, characterized by comedones, inflammatory lesions, secondary dyspigmentation, and scarring. Although traditionally considered a disease of adolescence, reports suggest it is also a disease of adults, especially adult women. Our objectives were to determine acne prevalence in a large, diverse group of women and to examine acne by subtype and in relation to other skin findings, measurements, and lifestyle factors. METHODS: We recruited 2895 women aged 10-70 from the general population. Photographs were graded for acne lesions, scars, and dyspigmentation. Measurements were taken of sebum excretion and pore size, and survey data were collected. RESULTS: Of the women studied, 55% had some form of acne: 28% had mild acne, and 27% had clinical acne, 14% of which was primarily inflammatory and 13% of which was primarily comedonal. Acne peaked in the teenage years, but 45% of women aged 21-30, 26% aged 31-40, and 12% aged 41-50 had clinical acne. Women with inflammatory acne were younger than those with comedonal acne (p≤0.001), and postmenopausal women had less acne than age-matched peers (p<0.0001). Acne was associated with facial hirsutism (p=0.001), large pores (p=0.001), and sebum excretion (p=0.002). Smokers had more, primarily comedonal, acne than nonsmokers. CONCLUSIONS: The cross-sectional design precludes conclusions about progression of acne with age. Participation was restricted to women. The photographic nature of the study imposes general limitations. Techniques used in this study were not sufficiently sensitive to identify cases of subclinical acne. More than a quarter of women studied had acne, which peaked in the teens but continued to be prevalent through the fifth decade.

Theory of mind may be contagious, but you don't catch it from your twin.

The theory-of-mind abilities of twins, children with nontwin siblings, and only children were compared to investigate further the link between number and type of siblings and theory-of-mind abilities. Three- to 5-year-old children with nontwin siblings outperformed both only children and twins with no other siblings, twins who also had other siblings outperformed twins who did not, and children with at least 1 opposite-sex sibling outperformed children with only same-sex siblings. Twins performed significantly better when asked about the false beliefs of their twins than they did when asked about the false beliefs of their friends. Results are discussed in terms of potential mechanisms that may account for the twin and sibling effects.