The effect of preoperative behaviour change interventions on pre- and post-surgery health behaviours, health outcomes, and health inequalities in adults: A systematic review and meta-analyses.

BACKGROUND: Prehabilitation interventions are being delivered across surgical specialities to improve health risk behaviours leading to better surgical outcomes and potentially reduce length of hospital stay. Most previous research has focused on specific surgery specialities and has not considered the impact of interventions on health inequalities, nor whether prehabilitation improves health behaviour risk profiles beyond surgery. The aim of this review was to examine behavioural Prehabilitation interventions across surgeries to inform policy makers and commissioners of the best available evidence. METHODS AND FINDINGS: A systematic review and meta-analysis of randomised controlled trials (RCTs) was conducted to determine the effect of behavioural prehabilitation interventions targeting at least one of: smoking behaviour, alcohol use, physical activity, dietary intake (including weight loss interventions) on pre- and post-surgery health behaviours, health outcomes, and health inequalities. The comparator was usual care or no treatment. MEDLINE, PubMed, PsychINFO, CINAHL, Web of Science, Google Scholar, Clinical trials and Embase databases were searched from inception to May 2021, and the MEDLINE search was updated twice, most recently in March 2023. Two reviewers independently identified eligible studies, extracted data, and assessed risk of bias using the Cochrane risk of bias tool. Outcomes were length of stay, six-minute walk test, behaviours (smoking, diet, physical activity, weight change, and alcohol), and quality of life. Sixty-seven trials were included; 49 interventions targeted a single behaviour and 18 targeted multiple behaviours. No trials examined effects by equality measures. Length of stay in the intervention group was 1.5 days shorter than the comparator (n = 9 trials, 95% CI -2.6 to -0.4, p = 0.01, I2 83%), although in sensitivity analysis prehabilitation had the most impact in lung cancer patients (-3.5 days). Pre-surgery, there was a mean difference of 31.8 m in the six-minute walk test favouring the prehabilitation group (n = 19 trials, 95% CI 21.2 to 42.4m, I2 55%, P <0.001) and this was sustained to 4-weeks post-surgery (n = 9 trials, mean difference = 34.4m (95%CI 12.8 to 56.0, I2 72%, P = 0.002)). Smoking cessation was greater in the prehabilitation group before surgery (RR 2.9, 95% CI 1.7 to 4.8, I2 84%), and this was sustained at 12 months post-surgery (RR 1.74 (95% CI 1.20 to 2.55, I2 43%, Tau2 0.09, p = 0.004)There was no difference in pre-surgery quality of life (n = 12 trials) or BMI (n = 4 trials). CONCLUSIONS: Behavioural prehabilitation interventions reduced length of stay by 1.5 days, although in sensitivity analysis the difference was only found for Prehabilitation interventions for lung cancer. Prehabilitation can improve functional capacity and smoking outcomes just before surgery. That improvements in smoking outcomes were sustained at 12-months post-surgery suggests that the surgical encounter holds promise as a teachable moment for longer-term behavioural change. Given the paucity of data on the effects on other behavioural risk factors, more research grounded in behavioural science and with longer-term follow-up is needed to further investigate this potential.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial.

BACKGROUND: Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. METHODS/DESIGN: This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. DISCUSSION: This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. TRIAL REGISTRATION: ISRCTN registry, ISRCTN59404712. Registered 28/11/17.