Tailoring CONSORT-SPI to improve the reporting of smoking cessation intervention trials: An expert consensus study.

BACKGROUND AND AIMS: Inadequate reporting of smoking cessation intervention trials is common and leads to significant challenges for researchers. The aim of this study was to tailor CONSORT (Consolidated Standards of Reporting Trials)-SPI (Social and Psychological Interventions) guidelines to improve reporting of trials of behavioural interventions to promote smoking cessation. METHOD: Informed by missing data from the IC-SMOKE (Intervention and Comparison group support provided in SMOKing cEssation) systematic review project, this study used a multi-stage Delphi process to examine which items could be added or modified to improve the reporting of smoking cessation trials. The first stage involved an on-line survey of 17 international experts in smoking cessation and trial methodology voting on the importance of items for inclusion in the updated guidelines. This was followed by a face-to-face expert consensus meeting attended by 15 of these experts, where the final inclusion and exclusion of new items and modifications were agreed upon. A nine-point Likert scale was used to establish consensus, with suggested modifications requiring agreement of 75% or more. Disagreements in the first stage were presented again at the second stage for discussion and a second round of voting. Only items which reached the threshold for agreement were included. RESULTS: The experts agreed on the inclusion of 10 new items and the specification of 12 existing items. This included modifications that could apply to trials more widely (e.g. the rationale for the comparator), but also modifications that were very specific to smoking cessation trials (e.g. the reporting of smoking cessation outcomes). CONCLUSIONS: A Delphi study has developed a modified CONSORT-SPI guideline (CONSORT-SPI-SMOKE) to improve the reporting of trials of behavioural interventions to promote smoking cessation.

Estimating the true effectiveness of smoking cessation interventions under variable comparator conditions: A systematic review and meta-regression.

BACKGROUND AND AIMS: Behavioural smoking cessation trials have used comparators that vary considerably between trials. Although some previous meta-analyses made attempts to account for variability in comparators, these relied on subsets of trials and incomplete data on comparators. This study aimed to estimate the relative effectiveness of (individual) smoking cessation interventions while accounting for variability in comparators using comprehensive data on experimental and comparator interventions. METHODS: A systematic review and meta-regression was conducted including 172 randomised controlled trials with at least 6 months follow-up and biochemically verified smoking cessation. Authors were contacted to obtain unpublished information. This information was coded in terms of active content and attributes of the study population and methods. Meta-regression was used to create a model predicting smoking cessation outcomes. This model was used to re-estimate intervention effects, as if all interventions have been evaluated against the same comparators. Outcome measures included log odds of smoking cessation for the meta-regression models and smoking cessation differences and ratios to compare relative effectiveness. RESULTS: The meta-regression model predicted smoking cessation rates well (pseudo R2 = 0.44). Standardising the comparator had substantial impact on conclusions regarding the (relative) effectiveness of trials and types of intervention. Compared with a 'no support comparator', self-help was 1.33 times (95% CI = 1.16-1.49), brief physician advice 1.61 times (95% CI = 1.31-1.90), nurse individual counselling 1.76 times (95% CI = 1.62-1.90), psychologist individual counselling 2.04 times (95% CI = 1.95-2.15) and group psychologist interventions 2.06 times (95% CI = 1.92-2.20) more effective. Notably, more elaborate experimental interventions (e.g. psychologist counselling) were typically compared with more elaborate comparators, masking their effectiveness. CONCLUSIONS: Comparator variability and underreporting of comparators obscures the interpretation, comparison and generalisability of behavioural smoking cessation trials. Comparator variability should, therefore, be taken into account when interpreting and synthesising evidence from trials. Otherwise, policymakers, practitioners and researchers may draw incorrect conclusions about the (cost) effectiveness of smoking cessation interventions and their constituent components.

Using machine learning to extract information and predict outcomes from reports of randomised trials of smoking cessation interventions in the Human Behaviour-Change Project.

Background  Using reports of randomised trials of smoking cessation interventions as a test case, this study aimed to develop and evaluate machine learning (ML) algorithms for extracting information from study reports and predicting outcomes as part of the Human Behaviour-Change Project. It is the first of two linked papers, with the second paper reporting on further development of a prediction system. Methods  Researchers manually annotated 70 items of information ('entities') in 512 reports of randomised trials of smoking cessation interventions covering intervention content and delivery, population, setting, outcome and study methodology using the Behaviour Change Intervention Ontology. These entities were used to train ML algorithms to extract the information automatically. The information extraction ML algorithm involved a named-entity recognition system using the 'FLAIR' framework. The manually annotated intervention, population, setting and study entities were used to develop a deep-learning algorithm using multiple layers of long-short-term-memory (LSTM) components to predict smoking cessation outcomes. Results  The F1 evaluation score, derived from the false positive and false negative rates (range 0-1), for the information extraction algorithm averaged 0.42 across different types of entity (SD=0.22, range 0.05-0.88) compared with an average human annotator's score of 0.75 (SD=0.15, range 0.38-1.00). The algorithm for assigning entities to study arms ( e.g., intervention or control) was not successful. This initial ML outcome prediction algorithm did not outperform prediction based just on the mean outcome value or a linear regression model. Conclusions  While some success was achieved in using ML to extract information from reports of randomised trials of smoking cessation interventions, we identified major challenges that could be addressed by greater standardisation in the way that studies are reported. Outcome prediction from smoking cessation studies may benefit from development of novel algorithms, e.g., using ontological information to inform ML (as reported in the linked paper 3).

The Achieving Self-directed Integrated Cancer Aftercare Intervention for Detection of Recurrent and Second Primary Melanoma in Survivors of Melanoma: Pilot Randomized Controlled Trial.

BACKGROUND: Melanoma is common with increasing incidence. Guidelines recommend monthly total skin self-examinations (TSSEs) by survivors to detect recurrent and new primary melanomas. TSSE is underperformed despite evidence of benefit. OBJECTIVE: This study compares the effect on psychological well-being and TSSE practice of a self-directed digital intervention with treatment as usual in patients treated for a first stage 0 to IIC primary cutaneous melanoma within the preceding 60 months. METHODS: This randomized clinical trial was conducted at 2 UK National Health Service hospitals (Aberdeen Royal Infirmary, Grampian, and Addenbrooke's, Cambridge). Adults (≥18 years) diagnosed with a first 0 to IIC primary cutaneous melanoma were randomized to receive Achieving Self-directed Integrated Cancer Aftercare (ASICA), a tablet-based intervention prompting and supporting TSSE in survivors of melanoma, or to usual care. The hypothesis was that ASICA would increase TSSE practice in users affected by melanoma and compared with controls without affecting psychological well-being. The main primary outcomes were melanoma worry (Melanoma Worry Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (EQ-5D-5L) as well as secondary outcomes collected using postal questionnaires 3, 6, and 12 months following randomization. RESULTS: A total of 240 recruits were randomized (1:1) into the ASICA (n=121, 50.4%) or control (n=119, 49.6%) groups. There were no significant differences between groups for melanoma worry at 12 months (mean difference: 0.12, 95% CI -0.6 to 0.84; P=.74), 3 months (0.23, 95% CI -0.31 to 0.78; P=.40), or 6 months (-0.1, 95% CI -0.7 to 0.51; P=.76). The ASICA group had lower anxiety scores at 12 months (-0.54, 95% CI -1.31 to 0.230; P=.17), 3 months (-0.13, 95% CI -0.79 to 0.54; P=.71), and significantly at 6 months (-1.00, 95% CI -1.74 to -0.26; P=.009). Depression scores were similar, being lower at 12 months (-0.44, 95% CI -1.11 to 0.23; P=.20) and 3 months (-0.24, 95% CI -0.84 to 0.35; P=.42) but only significantly lower at 6 months (-0.77, 95% CI -1.41 to -0.12; P=.02). The ASICA group had significantly higher quality of life scores at 12 months (0.044, 95% CI 0.003-0.085; P=.04) and 6 months (0.070, 95% CI 0.032-0.107; P<.001) and nonsignificantly at 3 months (0.024, 95% CI -0.006 to 0.054; P=.11). ASICA users reported significantly more regular (>5) TSSEs during the study year and significantly higher levels of self-efficacy in conducting TSSE. They also reported significantly higher levels of planning and intention to perform TSSE in the future. CONCLUSIONS: Using ASICA for 12 months does not increase melanoma worry, can reduce anxiety and depression, and may improve quality of life. ASICA has the potential to improve the well-being and vigilance of survivors of melanoma and enable the benefits of regular TSSE. TRIAL REGISTRATION: ClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3453-x.

Describing, predicting and explaining adherence to total skin self-examination (TSSE) in people with melanoma: a 12-month longitudinal study.

OBJECTIVES: To describe trajectories in melanoma survivors' adherence to monthly total skin self-examination (TSSE) over 12 months, and to investigate whether adherence trajectories can be predicted from demographic, cognitive or emotional factors at baseline. DESIGN: A longitudinal observational study nested within the intervention arm of the ASICA (Achieving Self-Directed Integrated Cancer Aftercare) randomised controlled trial. SETTING: Follow-up secondary care in Aberdeen and Cambridge UK. PARTICIPANTS: n=104 adults (48 men/56 women; mean age 58.83 years, SD 13.47, range 28-85 years; mean Scottish Index of Multiple Deprivation score 8.03, SD 1.73, range 2-10) who had been treated for stage 0-IIC primary cutaneous melanoma in the preceding 60 months and were actively participating in the intervention arm of the ASICA trial. INTERVENTIONS: All participants were using the ASICA intervention-a tablet-based intervention designed to support monthly TSSE. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was adherence to guideline recommended (monthly) TSSE over 12 months. This was determined from time-stamped TSSE data recorded by the ASICA intervention app. RESULTS: Latent growth mixture models identified three TSSE adherence trajectories (adherent -41%; drop-off -35%; non-adherent -24%). People who were non-adherent were less likely to intend to perform TSSE as recommended, intending to do it more frequently (OR=0.21, 95% CI 0.06 to 0.81, p=0.023) and were more depressed (OR=1.31, 95% CI 1.06 to 1.61, p=0.011) than people who were adherent. People whose adherence dropped off over time had less well-developed action plans (OR=0.78, 95% CI 0.63 to 0.96, p=0.016) and lower self-efficacy about TSSE (OR=0.92, 95% CI 0.86 to 0.99, p=0.028) than people who were adherent. CONCLUSIONS: Adherence to monthly TSSE in people treated for melanoma can be differentiated into adherent, drop-off and non-adherent trajectories. Collecting information about intentions to engage in TSSE, depression, self-efficacy and/or action planning at outset may help to identify those who would benefit from additional intervention. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03328247).

Pragmatic evaluation of methods for retrieving unpublished information on comparator interventions in a systematic review of smoking cessation trials.

OBJECTIVE: Reporting of the content and delivery characteristics of comparator interventions in published articles is often incomplete. This study examines the feasibility and validity of two methods for collecting additional information on comparator interventions from trial authors. METHODS & MEASURES: In a systematic review of smoking cessation trials (IC-Smoke), all trial authors were asked to send unpublished comparator intervention materials and complete a specially-developed comparator intervention checklist. All published and additionally obtained information from authors were coded for behaviour change techniques (BCTs) and other characteristics (type of comparator, provider, provider training, delivery mode and treatment duration). To assess representativeness, we assessed the amount of additional information obtained from trial authors compared with the amount that was published. We examined known-group and convergent validity of comparator intervention data when using only published or also unpublished information. RESULTS: Additional information were obtained from 91/136 (67%) of trial authors. Representativeness, known-group and convergent validity improved substantially based on the data collected by means of the comparator intervention checklist, but not by requesting authors to send any existing comparator materials. CONCLUSIONS: Requesting authors for unpublished comparator intervention data, using specially-developed checklists and unpublished materials, substantially improves the quality of data available for systematic reviews.

Predictors of recruitment and retention in randomized controlled trials of behavioural smoking cessation interventions: a systematic review and meta-regression analysis.

AIM: To investigate predictors of participant eligibility, recruitment and retention in behavioural randomized controlled trials (RCTs) for smoking cessation. METHOD: Systematic review and pre-specified meta-regression analysis of behavioural RCTs for smoking cessation including adult (≥ 18-year-old) smokers. The pre-specified predictors were identified through a literature review and experts' consultation and included participant, trial and intervention characteristics and recruitment and retention strategies. Outcome measures included eligibility rates (proportion of people eligible for the trials), recruitment rates, retention rates and differential retention rates. RESULTS: A total of 172 RCTs with 89 639 participants. Eligibility [median 57.6%; interquartile range (IQR) = 34.7-83.7], recruitment (median 66.4%; IQR = 42.7-85.2) and retention rates (median 80.5%; IQR = 68.5-89.5) varied considerably across studies. For eligibility rates, the recruitment strategy appeared not to be associated with eligibility rates. For recruitment rates, use of indirect recruitment strategies (e.g. public announcements) [odds ratio (OR) = 0.30, 95% confidence interval (CI) = 0.11-0.82] and self-help interventions (OR = 0.14, 95% CI = 0.03-0.67) were associated with lower recruitment rates. For retention rates, higher retention was seen if the sample had ongoing physical health condition/s (OR = 1.66, 95% CI = 1.04-2.63), whereas lower retention was seen amongst primarily female samples (OR = 0.83, 95% CI = 0.71-0.98) and those motivated to quit smoking (OR = 0.74, 95% CI = 0.55-0.99) when indirect recruitment methods were used (OR = 0.60, 95% CI = 0.38-0.97) and at longer follow-up assessments (OR = 0.83, 95% CI = 0.79-0.87). For differential retention, higher retention in the intervention group occurred when the intervention but not comparator group received financial incentives for smoking cessation (OR = 1.35, 95% CI = 1.02-1.77). CONCLUSIONS: In randomized controlled trials of behavioural smoking cessation interventions, recruitment and retention rates appear to be higher for smoking cessation interventions that include a person-to-person rather than at-a-distance contact; male participants, smokers with chronic conditions, smokers not initially motivated to quit and shorter follow-up assessments seems to be associated with improved retention; financial incentive interventions improve retention in groups receiving them relative to comparison groups.

Achieving integrated self-directed Cancer aftercare (ASICA) for melanoma: how a digital intervention to support total skin self-examination was used by people treated for cutaneous melanoma.

BACKGROUND: Melanoma incidence has quadrupled since 1970 and melanoma is now the second most common cancer in individuals under 50. Targeted immunotherapies for melanoma now potentially enable long-term remission even in advanced melanoma, but these melanoma survivors require ongoing surveillance, with implications for NHS resources and significant social and psychological consequences for patients. Total skin self-examination (TSSE) can detect recurrence earlier and improve clinical outcomes but is underperformed in the UK. To support survivors, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) intervention was developed to prompt and improve TSSE performance, with subsequent reporting of concerns and submission of skin photos to a Dermatology Nurse Practitioner (DNP). ASICA was delivered as a randomized pilot trial. METHODS: This paper reports on process evaluation. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using Microsoft Excel and SPSS. We explored which participants used ASICA, and how frequently, to report any skin concerns. We also determined how the interactions had worked in terms of quality of skin photographs submitted, clinical assessments made by the DNP, and the assessments and decisions made for each concern. Finally, we explored significant events occurring during the trial. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using SPSS. A semi-structured interview was undertaken with the DNP to gain perspective on the range of concerns presented and how they were resolved. RESULTS: Of 121 recruited melanoma patients receiving ASICA for 12 months, 69 participants submitted a total of 123 reports detailing 189 separate skin-related concerns and including 188 skin photographs. Where participants fully complied with follow-up by the DNP, concerns were usually resolved remotely, but 19 (10.1%) were seen at a secondary care clinic and 14 (7.4%) referred to their GP. 49 (25.9%) of concerns were not completely resolved due to partial non-compliance with DNP follow-up. CONCLUSION: Melanoma patients randomized to the ASICA intervention were able to report skin-related concerns that could be resolved remotely through interaction with a DNP. Feasibility issues highlighted by ASICA will support further development and optimization of this digital tool. TRIAL REGISTRATION: Clinical Trials.gov , NCT03328247 . Registered on 1 November 2017.

What Competences Are Required to Deliver Person-Person Behaviour Change Interventions: Development of a Health Behaviour Change Competency Framework.

BACKGROUND: The competence of the person delivering person-to-person behaviour change interventions may influence the effectiveness of the intervention. However, we lack a framework for describing the range of competences involved. The objective of the current work was to develop a competency framework for health behaviour change interventions. METHOD: A preliminary framework was developed by two judges rating the relevance of items in the competency framework for cognitive behaviour therapies; adding relevant items from reviews and other competency frameworks; and obtaining feedback from potential users on a draft framework. The Health Behaviour Change Competency Framework (HBCCF) was used to analyse the competency content of smoking cessation manuals. RESULTS: Judges identified 194 competency items as relevant, which were organised into two domains: foundation (12 competency topics comprising 56 competencies) and behaviour change (12 topics, 54 competencies); several of the 54 and 56 competencies were composed of sub-competencies (84 subcompetencies in total). Smoking cessation manuals included 14 competency topics from the foundation and behaviour change competency domains. CONCLUSION: The HBCCF provides a structured method for assessing and reporting competency to deliver behaviour change interventions. It can be applied to assess a practitioner's competency and training needs and to identify the competencies needed for a particular intervention. To date, it has been used in self-assessments and in developing training programmes. We propose the HBCCF as a practical tool for researchers, employers, and those who design and provide training. We envisage the HBCFF maturing and adapting as evidence that identifies the essential elements required for the effective delivery of behaviour change interventions emerges.

Underreporting of the active content of behavioural interventions: a systematic review and meta-analysis of randomised trials of smoking cessation interventions.

Despite its importance, underreporting of the active content of experimental and comparator interventions in published literature has not been previously examined for behavioural trials. We assessed completeness and variability in reporting in 142 randomised controlled trials of behavioural interventions for smoking cessation published between 1/1996 and 11/2015. Two coders reliably identified the potential active components of experimental and comparator interventions (activities targeting behaviours key to smoking cessation and qualifying as behaviour change techniques, BCTs) in published, and in unpublished materials obtained from study authors directly. Unpublished materials were obtained for 129/204 (63%) experimental and 93/142 (65%) comparator groups. For those, only 35% (1200/3403) of experimental and 26% (491/1891) of comparator BCTs could be identified in published materials. Reporting quality (#published BCTs/#total BCTs) varied considerably between trials and between groups within trials. Experimental (vs. comparator) interventions were better reported (B(SE) = 0.34 (0.11), p < .001). Unpublished materials were more often obtained for recent studies (B(SE) = 0.093 (0.03), p = .003) published in behavioural (vs. medical) journals (B(SE) = 1.03 (0.41), p = .012). This high variability in underreporting of active content compromises reader's ability to interpret the effects of individual trials, compare and explain intervention effects in evidence syntheses, and estimate the additional benefit of an experimental intervention in other settings.

Roles for Pharmacists in the "Ending the HIV Epidemic: A Plan for America" Initiative.

In 2019, President Trump announced a new initiative, Ending the HIV Epidemic: A Plan for America (EHE). EHE will use 3 key strategies-diagnose, treat, and prevent-to reduce new HIV infections at least 90% by 2030, as well as new laboratory methods and epidemiological techniques to respond quickly to potential outbreaks. Partnerships are an important component in the initiative's success. Pharmacists and pharmacies can play important roles in EHE, including dispensing antiretroviral therapy and providing HIV screening, adherence counseling, medication therapy management, preexposure prophylaxis, and nonprescription syringe sales. The objective of this report is to discuss potential roles that pharmacists and pharmacies can play under the key strategies of EHE.

Behaviour change techniques associated with smoking cessation in intervention and comparator groups of randomized controlled trials: a systematic review and meta-regression.

AIMS: To estimate the strengths of associations between use of behaviour change techniques (BCTs) and clusters of BCTs in behavioural smoking cessation interventions and comparators with smoking cessation rates. METHOD: Systematic review and meta-regression of biochemically verified smoking cessation rates on BCTs in interventions and comparators in randomized controlled trials, adjusting for a priori-defined potential confounding variables, together with moderation analyses. Studies were drawn from the Cochrane Tobacco Addiction Group Specialised Register. Data were extracted from published and unpublished (i.e. obtained from study authors) study materials by two independent coders. Adequately described intervention (k = 143) and comparator (k = 92) groups were included in the analyses (n = 43 992 participants). Using bivariate mixed-effects meta-regressions, while controlling for key a priori confounders, we regressed smoking cessation on (a) three BCT groupings consistent with dual-process theory (i.e. associative, reflective motivational and self-regulatory), (b) 17 expert-derived BCT groupings (i.e. BCT taxonomy version 1 clusters) and (c) individual BCTs from the BCT taxonomy version 1. RESULTS: Among person-delivered interventions, higher smoking cessation rates were predicted by BCTs targeting associative and self-regulatory processes (B = 0.034, 0.041, P < 0.05), and by three individual BCTs (prompting commitment, social reward, identity associated with changed behaviour). Among written interventions, BCTs targeting taxonomy cluster 10a (rewards) predicted higher smoking cessation (B = 0.394, P < 0.05). Moderation effects were observed for nicotine dependence, mental health status and mode of delivery. CONCLUSIONS: Among person-delivered behavioural smoking cessation interventions, specific behaviour change techniques and clusters of techniques are associated with higher success rates.

Variability and effectiveness of comparator group interventions in smoking cessation trials: a systematic review and meta-analysis.

AIMS: To examine variability and effectiveness of interventions provided to comparator (control) groups in smoking cessation trials. METHODS: Systematic review with meta-analysis of randomized controlled trials (RCTs) of behavioral interventions for smoking cessation, with or without stop-smoking medication. We searched the Cochrane Tobacco Addiction Group Specialized Register for RCTs with objective outcomes measured at ≥ 6 months. Study authors were contacted to obtain comprehensive descriptions of their comparator interventions. Meta-regression analyses examined the relationships of smoking cessation rates with stop-smoking medication and behavior change techniques. RESULTS: One hundred and four of 142 eligible comparator groups (n = 23 706) had complete data and were included in analyses. There was considerable variability in the number of behavior change techniques delivered [mean = 15.97, standard deviation (SD) = 13.54, range = 0-45] and the provision of smoking cessation medication (43% of groups received medication) throughout and within categories of comparator groups (e.g. usual care, brief advice). Higher smoking cessation rates were predicted by provision of medication [B = 0.334, 95% confidence interval (CI) = 0.030-0.638, P = 0.031] and number of behavior change techniques included (B = 0.020, 95% CI = 0.008-0.032, P < 0.001). Modelled cessation rates in comparator groups that received the most intensive support were 15 percentage points higher than those that received the least (23 versus 8%). CONCLUSIONS: Interventions delivered to comparator groups in smoking cessation randomized controlled trials vary considerably in content, and cessation rates are strongly predicted by stop-smoking medication and number of behavior change techniques delivered.

Enhancing Behavior Change Technique Coding Methods: Identifying Behavioral Targets and Delivery Styles in Smoking Cessation Trials.

BACKGROUND: The behavior change technique (BCT) taxonomy v1 is often used in systematic reviews for identifying active components of interventions. Its utility could be enhanced by linking BCTs to specific target behaviors and qualifying BCT delivery style. PURPOSE: To determine whether behavioral targets and delivery styles of BCTs can be coded reliably and to determine the utility of coding these characteristics. METHODS: As part of a large systematic review of 142 smoking cessation trials, two researchers independently coded publicly and privately held intervention and comparator group materials, specifying the behavioral target (quitting, abstinence, medication adherence, or treatment engagement) and delivery style (tailored vs. not tailored; active participation vs. passive receipt) of each BCT. RESULTS: Researchers coded 3,843 BCTs, which were reliably attributed to behavioral targets (AC1 = 0.92, PABAK = 0.91). Tailoring (AC1 = 0.80, PABAK = 0.74) and participation (AC1 = 0.71, PABAK = 0.64) were also coded reliably. There was considerable variability between groups in quitting and abstinence BCTs (ranges: 0-41; 0-18) and in tailoring and participation (ranges: 0-20; 0-32), but less variability for medication adherence and treatment engagement (ranges: 0-6; 0-7). CONCLUSIONS: Behavioral targets and delivery styles of BCTs can be reliably identified and occur with sufficient frequency in smoking cessation trials for inclusion in quantitative syntheses (e.g., meta-regression analyses). Systematic reviewers could consider adopting these methods to evaluate the impact of intervention components targeting different behaviors, as well as the benefits of different BCT delivery styles.

Interventions to Promote Healthy Eating, Physical Activity and Smoking in Low-Income Groups: a Systematic Review with Meta-Analysis of Behavior Change Techniques and Delivery/Context.

PURPOSE: Healthy eating, physical activity and smoking interventions for low-income groups may have small, positive effects. Identifying effective intervention components could guide intervention development. This study investigated which content and delivery components of interventions were associated with increased healthy behavior in randomised controlled trials (RCTs) for low-income adults. METHOD: Data from a review showing intervention effects in 35 RCTs containing 45 interventions with 17,000 participants were analysed to assess associations with behavior change techniques (BCTs) and delivery/context components from the template for intervention description and replication (TIDieR) checklist. The associations of 46 BCTs and 14 delivery/context components with behavior change (measures of healthy eating, physical activity and smoking cessation) were examined using random effects subgroup meta-analyses. Synergistic effects of components were examined using classification and regression trees (meta-CART) analyses based on both fixed and random effects assumptions. RESULTS: For healthy eating, self-monitoring, delivery through personal contact, and targeting multiple behaviors were associated with increased effectiveness. Providing feedback, information about emotional consequences, or using prompts and cues were associated with reduced effectiveness. In synergistic analyses, interventions were most effective without feedback, or with self-monitoring excluding feedback. More effective physical activity interventions included behavioral practice/rehearsal or instruction, focussed solely on physical activity or took place in home/community settings. Information about antecedents was associated with reduced effectiveness. In synergistic analyses, interventions were most effective in home/community settings with instruction. No associations were identified for smoking. CONCLUSION: This study identified BCTs and delivery/context components, individually and synergistically, linked to increased and reduced effectiveness of healthy eating and physical activity interventions. The identified components should be subject to further experimental study to help inform the development effective behavior change interventions for low-income groups to reduce health inequalities.

Component network meta-analysis identifies the most effective components of psychological preparation for adults undergoing surgery under general anesthesia.

OBJECTIVES: To apply component network meta-analysis (CNMA) models to an existing Cochrane review of psychological preparation interventions for adults undergoing surgery and to extend the models to account for covariates to identify the most effective components for improving postoperative outcomes. STUDY DESIGN AND SETTING: Interventions consisted of between one and four components of psychological preparation: procedural information (P), sensory information (S), behavioral instruction (B), cognitive interventions (C), relaxation (R), and emotion-focused techniques (E). We used CNMA models to assess the effect of each component for three outcomes: length of stay, pain, and negative affect. RESULTS: We found evidence that the most effective component for reducing length of stay depends on the type of surgery and that R may improve pain. There was insufficient evidence that individual components contributed to the overall reduction in negative affect, but P and S emerged as the most likely beneficial components. Overall, we were unable to identify any one component as the most effective across all three outcomes. CONCLUSION: The CNMA method allowed us to address questions about the effects of specific components that could not be answered using standard Cochrane methodology.

Do patients' faces influence General Practitioners' cancer suspicions? A test of automatic processing of sociodemographic information.

BACKGROUND: Delayed cancer diagnosis leads to poorer patient outcomes. During short consultations, General Practitioners (GPs) make quick decisions about likelihood of cancer. Patients' facial cues are processed rapidly and may influence diagnosis. AIM: To investigate whether patients' facial characteristics influence immediate perception of cancer risk by GPs. DESIGN AND SETTING: Web-based binary forced choice experiment with GPs from Northeast Scotland. METHOD: GPs were presented with a series of pairs of face prototypes and asked to quickly select the patient more likely to have cancer. Faces were modified with respect to age, gender, and ethnicity. Choices were analysed using Chi-squared goodness-of-fit statistics with Bonferroni corrections. RESULTS: Eighty-two GPs participated. GPs were significantly more likely to suspect cancer in older patients. Gender influenced GP cancer suspicion, but this was modified by age: the male face was chosen as more likely to have cancer than the female face for young (72% of GPs;95% CI 61.0-87.0) and middle-aged faces (65.9%; 95% CI 54.7-75.5); but 63.4% (95% CI 52.2-73.3) decided the older female was more likely to have cancer than the older male (p = 0.015). GPs were significantly more likely to suspect cancer in the young Caucasian male (65.9% (95% CI 54.7, 75.5)) compared to the young Asian male (p = 0.004). CONCLUSION: GPs' first impressions about cancer risk are influenced by patient age, gender, and ethnicity. Tackling GP cognitive biases could be a promising way of reducing cancer diagnostic delays, particularly for younger patients.

Reporting behaviour change interventions: do the behaviour change technique taxonomy v1, and training in its use, improve the quality of intervention descriptions?

BACKGROUND: Behaviour change interventions are likely to be reproducible only if reported clearly. We assessed whether the behaviour change technique taxonomy version 1 (BCTTv1), with and without training in identifying BCTs, improves the clarity and replicability of written reports of observed behaviour change interventions. METHODS: Three studies assessed effects of using and training in the use of BCTTv1 on the clarity and replicability of intervention descriptions written after observing videos of smoking cessation interventions. Study 1 examined the effects of using and not using BCTTv1. Study 2 examined the effects of using BCTTv1 and training in use of BCTTv1 compared no use and no training. Study 3 employed a within-group design to assess change in descriptions written before and after training. One-hundred and 66 'writers' watched videos of behaviour change interventions and wrote descriptions of the active components delivered. In all studies, the participants' written descriptions were evaluated by (i) 12 'raters' (untrained in BCTTv1) for clarity and replicability and (ii) 12 'coders' (trained in BCTTv1) for reliability of BCT coding. Writers rated the usability and accessibility of using BCTTv1 to write descriptions. RESULTS: Ratings of clarity and replicability did not differ between groups in study 1 (all ps > 0.05), were poorer for trained users in study 2 (all ps < 0.01) and improved following training in study 3 (all ps < 0.05). BCT identification was more reliable from descriptions written by trained BCTTv1 users (p < 0.05; study 2) but not simple use of BCTTv1 (p = 0.93; study 1) or by writers who had written a description without BCTTv1, before training (p = 0.50; study 3). Writers reported that using BCTTv1 was difficult but 'useful', 'good' and 'desirable' and that their descriptions would be clear and replicable (all means above mid-point of the scale). CONCLUSIONS: Effects of training to use BCTTv1 on the quality of written reports of observed interventions were mixed, with some suggestion of improved clarity and replicability of reporting in the within- (study 3) but not the between-group studies (studies 1 and 2). Potential benefits of using BCTTv1 may have been limited by the artificial nature and time constraints of the task.

Psychological preparation and postoperative outcomes for adults undergoing surgery under general anaesthesia.

BACKGROUND: In a review and meta-analysis conducted in 1993, psychological preparation was found to be beneficial for a range of outcome variables including pain, behavioural recovery, length of stay and negative affect. Since this review, more detailed bibliographic searching has become possible, additional studies testing psychological preparation for surgery have been completed and hospital procedures have changed. The present review examines whether psychological preparation (procedural information, sensory information, cognitive intervention, relaxation, hypnosis and emotion-focused intervention) has impact on the outcomes of postoperative pain, behavioural recovery, length of stay and negative affect. OBJECTIVES: To review the effects of psychological preparation on postoperative outcomes in adults undergoing elective surgery under general anaesthetic. SEARCH METHODS: We searched the Cochrane Register of Controlled Trials (CENTRAL 2014, Issue 5), MEDLINE (OVID SP) (1950 to May 2014), EMBASE (OVID SP) (1982 to May 2014), PsycINFO (OVID SP) (1982 to May 2014), CINAHL (EBESCOhost) (1980 to May 2014), Dissertation Abstracts (to May 2014) and Web of Science (1946 to May 2014). We searched reference lists of relevant studies and contacted authors to identify unpublished studies. We reran the searches in July 2015 and placed the 38 studies of interest in the `awaiting classification' section of this review. SELECTION CRITERIA: We included randomized controlled trials of adult participants (aged 16 or older) undergoing elective surgery under general anaesthesia. We excluded studies focusing on patient groups with clinically diagnosed psychological morbidity. We did not limit the search by language or publication status. We included studies testing a preoperative psychological intervention that included at least one of these seven techniques: procedural information; sensory information; behavioural instruction; cognitive intervention; relaxation techniques; hypnosis; emotion-focused intervention. We included studies that examined any one of our postoperative outcome measures (pain, behavioural recovery, length of stay, negative affect) within one month post-surgery. DATA COLLECTION AND ANALYSIS: One author checked titles and abstracts to exclude obviously irrelevant studies. We obtained full reports of apparently relevant studies; two authors fully screened these. Two authors independently extracted data and resolved discrepancies by discussion.Where possible we used random-effects meta-analyses to combine the results from individual studies. For length of stay we pooled mean differences. For pain and negative affect we used a standardized effect size (the standardized mean difference (SMD), or Hedges' g) to combine data from different outcome measures. If data were not available in a form suitable for meta-analysis we performed a narrative review. MAIN RESULTS: Searches identified 5116 unique papers; we retrieved 827 for full screening. In this review, we included 105 studies from 115 papers, in which 10,302 participants were randomized. Mainly as a result of updating the search in July 2015, 38 papers are awaiting classification. Sixty-one of the 105 studies measured the outcome pain, 14 behavioural recovery, 58 length of stay and 49 negative affect. Participants underwent a wide range of surgical procedures, and a range of psychological components were used in interventions, frequently in combination. In the 105 studies, appropriate data were provided for the meta-analysis of 38 studies measuring the outcome postoperative pain (2713 participants), 36 for length of stay (3313 participants) and 31 for negative affect (2496 participants). We narratively reviewed the remaining studies (including the 14 studies with 1441 participants addressing behavioural recovery). When pooling the results for all types of intervention there was low quality evidence that psychological preparation techniques were associated with lower postoperative pain (SMD -0.20, 95% confidence interval (CI) -0.35 to -0.06), length of stay (mean difference -0.52 days, 95% CI -0.82 to -0.22) and negative affect (SMD -0.35, 95% CI -0.54 to -0.16) compared with controls. Results tended to be similar for all categories of intervention, although there was no evidence that behavioural instruction reduced the outcome pain. However, caution must be exercised when interpreting the results because of heterogeneity in the types of surgery, interventions and outcomes. Narratively reviewed evidence for the outcome behavioural recovery provided very low quality evidence that psychological preparation, in particular behavioural instruction, may have potential to improve behavioural recovery outcomes, but no clear conclusions could be reached.Generally, the evidence suffered from poor reporting, meaning that few studies could be classified as having low risk of bias. Overall,we rated the quality of evidence for each outcome as 'low' because of the high level of heterogeneity in meta-analysed studies and the unclear risk of bias. In addition, for the outcome behavioural recovery, too few studies used robust measures and reported suitable data for meta-analysis, so we rated the quality of evidence as `very low'. AUTHORS' CONCLUSIONS: The evidence suggested that psychological preparation may be beneficial for the outcomes postoperative pain, behavioural recovery, negative affect and length of stay, and is unlikely to be harmful. However, at present, the strength of evidence is insufficient to reach firm conclusions on the role of psychological preparation for surgery. Further analyses are needed to explore the heterogeneity in the data, to identify more specifically when intervention techniques are of benefit. As the current evidence quality is low or very low, there is a need for well-conducted and clearly reported research.

Identifying effective behavioural components of Intervention and Comparison group support provided in SMOKing cEssation (IC-SMOKE) interventions: a systematic review protocol.

BACKGROUND: Systematic reviews of behaviour change interventions for smoking cessation vary in scope, quality, and applicability. The current review aims to generate more accurate and useful findings by (1) a detailed analysis of intervention elements that change behaviour (i.e. behaviour change techniques (BCTs)) and potential moderators of behaviour change (i.e. other intervention and sample characteristics) and (2) assessing and controlling for variability in support provided to comparison groups in smoking cessation trials. METHODS: A systematic review will be conducted of randomized controlled trials of behaviour change interventions for smoking cessation in adults (with or without pharmacological support), with a minimum follow-up of 6 months, published after 1995. Eligible articles will be identified through the Cochrane Tobacco Addiction Group Specialized Register. Study authors will be asked for detailed descriptions of smoking cessation support provided to intervention and comparison groups. All data will be independently coded by two researchers. The BCT taxonomy v1 (tailored to smoking cessation interventions) and template for intervention description and replication criteria will be used to code intervention characteristics. Data collection will further include sample and trial characteristics and outcome data (smoking cessation rates). Multilevel mixed-effects meta-regression models will be used to examine which BCTs and/or BCT clusters delivered to intervention and comparison groups explain smoking cessation rates in treatment arms (and effect sizes) and what key moderators of behaviour change are. Predicted effect sizes of each intervention will be computed assuming all interventions are compared against comparison groups receiving the same levels of behavioural support (i.e. low, medium, and high levels). Multi-disciplinary advisory board members (policymakers, health care providers, and (ex-)smokers) will provide strategic input throughout the project to ensure the review's applicability to policy and practice. DISCUSSION: By capturing BCTs in intervention and comparison groups, this systematic review will provide more accurate estimates of the effectiveness of smoking cessation interventions, the most promising BCTs and/or BCT clusters associated with smoking cessation rates in intervention and comparison arms, and important moderators of behaviour change. The results could set new standards for conducting meta-analyses of behaviour change interventions and improve research, service delivery, and training in the area of smoking cessation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015025251.