Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17160

Barriers and facilitators to smoking cessation in pregnancy and postpartum : the healthcare professionals

Objectives: Healthcare professionals and the healthcare environment play a central role in protecting pregnant and postpartum women and their infants from smoking-related harms. This study aimed to better understand the health professional’s perspective on how interactions between women, healthcare professionals and the environment influence how smoking is managed. Design: Semi-structured interviews and focus groups. Methods: Data were from 48 healthcare staff involved in antenatal or postpartum care at two UK sites, including midwives, obstetricians, health visitors, GPs, pharmacists, service commissioners and Stop Smoking Service (SSS) advisors and managers. Thematic analysis was guided by a Social-Ecological Framework (SEF). Results: Themes were divided across three SEF levels and represented factors connected to the management of smoking in the healthcare context and the beliefs and behaviour of pregnant or postpartum smokers. Organisational level: service reconfigurations, 'last resort' nicotine replacement therapy prescribing policies, and non-mandatory training were largely negative factors. There were mixed views on opt-out referral pathways and positive views on carbon monoxide monitoring. Inter-personal level: protection of client-professional relationships often inhibited frank discussions about smoking, and weak inter-service relationships affected SSS referral motivation and quality. Individual level: professionals felt community midwives had primary responsibility for managing smoking, though midwives felt under-skilled doing this. Midwives’ perceived priority for addressing smoking was influenced by the demands from unrelated organisational initiatives. Conclusions: Opportunities to improve clinical support for pregnant smokers exist at organisational, inter-service and healthcare professional levels. Interactions between levels reflect the importance of simultaneously addressing different level-specific barriers to smoking cessation in pregnancy

Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the ‘Getting it Right:Addressing Shoulder Pain’ (GRASP) trial

The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, randomised controlled trial investigating the clinical and cost-effectiveness of a progressive exercise intervention versus a best-practice advice intervention, with or without corticosteroid injection, for treating people with a rotator cuff disorder. Interventions were developed using the Medical Research Council guidance on complex interventions, and included a stakeholder meeting of 26 clinicians, researchers, and patient representatives. The best-practice advice (1 session) and progressive exercise (≤6 sessions over 16 weeks) interventions both involve face-to-face, one-to-one physiotherapist appointments and include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. The results of the GRASP trial are anticipated in 2020. This large scale evaluation on 704 participants will provide high quality evidence to best inform clinical practice for the management of people with shoulder pain due to a rotator cuff disorder. A critical stage of evaluating the complex interventions in the GRASP trial is ensuring details of the development and content of the interventions are available to clinicians and researchers to facilitate their implementation

A Context-Sensing Mobile Phone App (Q Sense) for Smoking Cessation: A Mixed-Methods Study.

BACKGROUND: A major cause of lapse and relapse to smoking during a quit attempt is craving triggered by cues from a smoker's immediate environment. To help smokers address these cue-induced cravings when attempting to quit, we have developed a context-aware smoking cessation app, Q Sense, which uses a smoking episode-reporting system combined with location sensing and geofencing to tailor support content and trigger support delivery in real time. OBJECTIVE: We sought to (1) assess smokers' compliance with reporting their smoking in real time and identify reasons for noncompliance, (2) assess the app's accuracy in identifying user-specific high-risk locations for smoking, (3) explore the feasibility and user perspective of geofence-triggered support, and (4) identify any technological issues or privacy concerns. METHODS: An explanatory sequential mixed-methods design was used, where data collected by the app informed semistructured interviews. Participants were smokers who owned an Android mobile phone and were willing to set a quit date within one month (N=15). App data included smoking reports with context information and geolocation, end-of-day (EoD) surveys of smoking beliefs and behavior, support message ratings, and app interaction data. Interviews were undertaken and analyzed thematically (N=13). Quantitative and qualitative data were analyzed separately and findings presented sequentially. RESULTS: Out of 15 participants, 3 (20%) discontinued use of the app prematurely. Pre-quit date, the mean number of smoking reports received was 37.8 (SD 21.2) per participant, or 2.0 (SD 2.2) per day per participant. EoD surveys indicated that participants underreported smoking on at least 56.2% of days. Geolocation was collected in 97.0% of smoking reports with a mean accuracy of 31.6 (SD 16.8) meters. A total of 5 out of 9 (56%) eligible participants received geofence-triggered support. Interaction data indicated that 50.0% (137/274) of geofence-triggered message notifications were tapped within 30 minutes of being generated, resulting in delivery of a support message, and 78.2% (158/202) of delivered messages were rated by participants. Qualitative findings identified multiple reasons for noncompliance in reporting smoking, most notably due to environmental constraints and forgetting. Participants verified the app's identification of their smoking locations, were largely positive about the value of geofence-triggered support, and had no privacy concerns about the data collected by the app. CONCLUSIONS: User-initiated self-report is feasible for training a cessation app about an individual's smoking behavior, although underreporting is likely. Geofencing was a reliable and accurate method of identifying smoking locations, and geofence-triggered support was regarded positively by participants

Embedding clinical research in pre-registration nursing and midwifery programmes

Background: Within the UK, there is a goal that research is embedded into everyday healthcare practice. Currently education provided to students at pre-registration level is theoretical, with little focus on clinical research delivery. Aims: The paper’s aim is to report on the development and evaluation of a pre-registration clinical research resource for nursing and midwifery students with direct application to clinical settings and patient care outcomes. Methods: An initial survey assessed whether the learning resource was useful for nursing pre-registration students. Based on the findings, alongside expert stakeholder input, adaptations were made to the learning resources and a second survey re-evaluated the learning resources. Survey findings were analysed using descriptive statistics. Free text responses were thematically grouped. Results: Ninety-seven pre-registration nursing students responded. Most students agreed that they had enjoyed using the resources, had improved understanding of clinical research, anticipated being actively involved in research and would consider a future clinical research role. Conclusions: The learning resources can help overcome barriers to research engagement by nurses and midwives. The results demonstrate that research can be incorporated into clinical, educational and academic roles, highlighting their worth in supporting the clinical research workforce

Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial [version 1; peer review: 2 approved]

Objectives: The Anti-Freaze-F trial will assess the feasibility of conducting a large randomised controlled trial to assess whether intra-articular injection of anti-TNF (adalimumab) can reduce pain and improve function in people with pain predominant early stage frozen shoulder. Methods and analysis: We are conducting a multi-centre, randomised feasibility study, with an embedded qualitative sub-study. We will recruit adults ≥18 years with a new episode of shoulder pain attributable to early stage frozen shoulder, recruited from at least five UK NHS musculoskeletal and related physiotherapy services. Participants (n=84) will be randomised (centralised computer generated 1:1 allocation) to receive either: 1) intra-articular injection of anti-TNF (adalimumab 160mg) or 2) placebo injection (saline [0.9% sodium chloride]), both under ultrasound guidance. A second injection of the allocated treatment (adalimumab 80mg) or equivalent volume of placebo will be administered 2-3 weeks later. All participants will receive a physiotherapy advice leaflet providing education and advice about frozen shoulder and pain management. The primary feasibility objectives are: 1) the ability to screen and identify potential participants with pain predominant early stage frozen shoulder; 2) willingness of eligible participants to consent and be randomised to intervention; 3) practicalities of delivering the intervention, including time to first injection and number of participants receiving second injection; 4) standard deviation of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months from baseline in order to estimate the sample size for a definitive trial. We will also assess follow up rates and viability of patient-reported outcome measures and range of shoulder motion for a definitive trial.  Research Ethics Committee approval (REC 21/NE/0214). Trial registration number: ISRCTN 27075727; EudraCT number: 2021-003509-23; ClinicalTrials.gov NCT05299242

A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery

AIMS: This study aims to assess the feasibility of conducting a pragmatic, multi-centre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. METHODS: A mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomised to usual NHS care versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; and pacing and stress management techniques and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomisation will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data and clinical outcomes assessing quality of life, physical, emotional, adverse event and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals. DISCUSSION: A multi-centre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery

Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis:Protocol for 2 Independent Meta-Research Studies

Background: Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies’ risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. Objective: We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. Methods: Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. Results: The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. Conclusions: Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field