Views on and experiences of electronic cigarettes: a qualitative study of women who are pregnant or have recently given birth.

BACKGROUND: Electronic cigarettes (ECs) are increasingly used for reducing or stopping smoking, with some studies showing positive outcomes. However, little is known about views on ECs during pregnancy or postpartum and previous studies have nearly all been conducted in the US and have methodological limitations, such as not distinguishing between smokers and ex/non-smokers. A greater understanding of this topic will help to inform both clinicians and EC interventions. We elicited views and experiences of ECs among UK pregnant or recently pregnant women. METHODS: We conducted semi-structured telephone interviews, using topic guides, with pregnant or recently pregnant women, who were current or recent ex-smokers. To ensure broad views of ECs were obtained, recruitment was from several geographical locations and via various avenues of recruitment. This included stop smoking services, antenatal and health visitor clinics, a pregnancy website and an informal network. Participants were 15 pregnant and 15 postpartum women, including nine current EC users, 11 ex-users, and 10 never-users. Five women who were interviewed in pregnancy were later interviewed in postpartum to explore if their views had changed. Audio data was transcribed verbatim and framework analysis was applied. RESULTS: Five main themes emerged: motivations for use (e.g., for stopping or reducing smoking), social stigma (e.g., avoiding use in public, preferring 'discrete' NRT), using the EC (e.g., mostly used at home); consumer aspects (e.g., limited advice available), and harm perceptions (e.g., viewed as less harmful than smoking; concerns about safety and addiction). CONCLUSIONS: ECs were viewed positively by some pregnant and postpartum women and seen as less harmful than smoking and useful as aids for reducing and stopping smoking. However, due to perceived social stigma, some women feel uncomfortable using ECs in public, especially during pregnancy, and had concerns about safety and nicotine dependence. Health professionals and designers of EC interventions need to provide women with up-to-date and consistent information and advice about safety and dependence, as well as considering the influence of social stigma.

How Tobacco Companies are Perceived Within the United Kingdom: An Online Panel.

INTRODUCTION: Little is known about how consumers perceive tobacco companies in the United Kingdom. METHODS: An online cross-sectional survey with those aged 16 years and over (N = 2253) explored perceptions of, and attitudes towards, tobacco companies. This included awareness of tobacco companies, views on tobacco companies' practices (targeting the most vulnerable, encouraging smoking to replace those who quit or die, making cigarettes more addictive) and values (honesty, ethics, interest in harm reduction), perceptions of regulation of tobacco companies (whether tobacco companies have the same marketing rights as other companies, should be allowed to promote cigarettes, be required to sell cigarettes in plain packs, and pay for associated health costs), and locus of responsibility for health problems caused by tobacco use. RESULTS: Prompted awareness of tobacco companies was high (68%). Almost a third of the sample had a negative perception of tobacco companies' practices, for example, they thought they made cigarettes more addictive. In terms of tobacco companies' values, less than a fifth considered tobacco companies honest, ethical, and interested in reducing the harm caused by cigarettes. Indeed, tobacco company executives were rated lower than the seven other professions asked about, except car salesman, in terms of ethics and honesty. More than half the sample supported greater regulation, for example, requiring tobacco companies to pay for health costs due to tobacco use. Most attributed responsibility for smoking-related health problems to smokers (88%) and tobacco companies (55%). CONCLUSIONS: The findings suggest that consumers are not fully informed about tobacco company practices. IMPLICATIONS: Few studies outside of North America have explored perceptions of tobacco companies' practices, values and regulation and responsibility for smoking-related illness. Adults surveyed within the United Kingdom considered tobacco companies dishonest, unethical and untrustworthy, but only a third of the sample thought that they encourage new smokers or have made cigarettes more addictive, and just over a half attributed most of the responsibility for smoking-related health problems to tobacco companies. As consumers do not appear fully informed about the role of tobacco companies in initiating and perpetuating the tobacco epidemic, tobacco industry denormalization campaigns may be of potential value.

Health professionals' perceptions of the barriers and facilitators to providing smoking cessation advice to women in pregnancy and during the post-partum period: a systematic review of qualitative research.

BACKGROUND: Reducing smoking in pregnancy is a policy priority in many countries and as a result there has been a rise in the development of services to help pregnant women to quit. A wide range of professionals are involved in providing these services, with midwives playing a particularly pivotal role. Understanding professionals' experiences of providing smoking cessation support in pregnancy can help to inform the design of interventions as well as to improve routine care. METHODS: A synthesis of qualitative research of health professionals' perceptions of the barriers and facilitators to providing smoking cessation advice to women in pregnancy and the post-partum period was conducted using meta-ethnography. Searches were undertaken from 1990 to January 2015 using terms for maternity health professionals and smoking cessation advisors, pregnancy, post-partum, smoking, and qualitative in seven electronic databases. The review was reported in accordance with the 'Enhancing transparency in reporting the synthesis of qualitative research' (ENTREQ) statement. RESULTS: Eight studies reported in nine papers were included, reporting on the views of 190 health professionals/key informants, including 85 midwives and health visitors. The synthesis identified that both the professional role of participants and the organisational context in which they worked could act as either barriers or facilitators to an individual's ability to provide smoking cessation support to pregnant or post-partum women. Underpinning these factors was an acknowledgment that the association between maternal smoking and social disadvantage was a considerable barrier to addressing and supporting smoking cessation CONCLUSIONS: The review identifies a role for professional education, both pre-qualification and in continuing professional development that will enable individuals to provide smoking cessation support to pregnant women. Key to the success of this education is recognising the centrality of the professional-client/patient relationship in any interaction. The review also highlights a widespread professional perception of the barriers associated with helping women give up smoking in pregnancy, particularly for those in disadvantaged circumstances. Improving the quality and accessibility of evidence on effective healthcare interventions, including evidence on 'what works' to support smoking cessation in disadvantaged groups, should therefore be a priority. PROSPERO 2013: CRD42013004170.

Safety of e-cigarettes and nicotine patches as stop-smoking aids in pregnancy: Secondary analysis of the Pregnancy Trial of E-cigarettes and Patches (PREP) randomized controlled trial.

AIMS: The aim of this study was to examine the safety of e-cigarettes (EC) and nicotine patches (NRT) when used to help pregnant smokers quit. DESIGN: A recent trial of EC versus NRT reported safety outcomes in the randomized arms. We conducted a further analysis based on product use. SETTING: Twenty-three hospitals in England and a stop-smoking service in Scotland took part. PARTICIPANTS: The participants comprised 1140 pregnant smokers. INTERVENTIONS: We compared women using and not using EC and NRT regularly during pregnancy. MEASUREMENTS: Measurements included nicotine intake compared with baseline, birth weight, other pregnancy outcomes, adverse events, maternal respiratory symptoms and relapse in early abstainers. FINDINGS: Use of EC was more common than use of NRT (47.3% vs 21.6%, P < 0.001). Women who stopped smoking (abstainers) and used EC at the end-of-pregnancy (EOP) reduced their salivary cotinine by 45% [49.3 ng/ml, 95% confidence interval (CI) = -79.8 to -10]. Only one abstainer used NRT at EOP. In dual users, cotinine increased by 19% (24 ng/ml, 95% CI = 3.5-68). In women reporting a reduction of at least 50% in cigarette consumption, cotinine levels increased by 10% in those using nicotine products and by 9% in those who did not. Birth weights in dual users and exclusive smokers were the same (3.1 kg). Birth weight in abstainers using either nicotine product was higher than in smokers [3.3 kg, standard deviation (SD) = 0.7] versus 3.1 kg, SD = 0.6; difference = 0.15 kg, 95% CI = 0.05-0.25) and not different from abstainers not using nicotine products (3.1 kg, SD = 0.8). Abstainers and smokers using nicotine products had no worse pregnancy outcomes or more adverse events than abstainers and smokers not using them. EC users reported more improvements than non-users in cough [adjusted relative risk (aRR) = 0.59, 95% CI = 0.37-0.93] and phlegm (aRR = 0.53, 95% CI = 0.31-0.92), controlling for smoking status. EC or NRT use had no association with relapse. CONCLUSIONS: Regular use of e-cigarettes or nicotine patches by pregnant smokers does not appear to be associated with any adverse outcomes.

Financial incentives for quitting smoking in pregnancy: Are they cost-effective?

AIMS: To evaluate whether adding financial incentives to usual care is cost-effective in encouraging pregnant women to quit tobacco smoking, compared with usual care alone. DESIGN: Cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a health-care provider's perspective, embedded in the Smoking Cessation in Pregnancy Incentives Trial (CPIT III). Long-term analyses were conducted from the same perspective, using an existing Markov model over a life-time horizon. SETTING: Seven maternity smoking cessation sites in Scotland, England and Northern Ireland in the United Kingdom. PARTICIPANTS: In the short-term analysis, CPIT III participants were assessed: women 16 years or older, self-reporting as smokers, fewer than 24 weeks pregnant and English-speaking (n = 944). The same population was used for the life-time analysis, plus their infants. MEASUREMENTS: Costs included financial incentive vouchers and postage, cessation support and nicotine replacement therapy and neonatal stays. The outcome measure was a biochemically verified quit rate for the CEA and quality-adjusted life-years (QALYs) for CUA. Costs are presented in 2020 GBP sterling (£). Data for the life-time analysis came from the trial and were combined with data from published literature embedded in the model, reporting incremental cost per quitter and QALY. A 3.5% discount rate was applied. FINDINGS: The short-term incremental cost per quitter was £4400 and cost per QALY was £150 000. Results of sensitivity analyses confirmed these results. The long-term analysis combined costs and outcomes for mother and infants; results showed a cost saving of £37 [95% confidence interval (CI]) = £35-106] and increase in QALYs of 0.171 (95% CI = 0.124-0.229). These findings indicate that, over a life-time, financial incentives are cost-saving and improve health outcomes. CONCLUSIONS: In the United Kingdom, offering up to £400 financial incentives, in addition to usual care, to support pregnant women to stop smoking appears to be highly cost-effective over a life-time for mother and infants.

Students' and staffs' views and experiences of asymptomatic testing on a university campus during the COVID-19 pandemic in Scotland: a mixed methods study.

OBJECTIVES: To explore the acceptability of regular asymptomatic testing for SARS-CoV-2 on a university campus using saliva sampling for PCR analysis and the barriers and facilitators to participation. DESIGN: Cross-sectional surveys and qualitative semistructured interviews. SETTING: Edinburgh, Scotland. PARTICIPANTS: University staff and students who had registered for the testing programme (TestEd) and provided at least one sample. RESULTS: 522 participants completed a pilot survey in April 2021 and 1750 completed the main survey (November 2021). 48 staff and students who consented to be contacted for interview took part in the qualitative research. Participants were positive about their experience with TestEd with 94% describing it as 'excellent' or 'good'. Facilitators to participation included multiple testing sites on campus, ease of providing saliva samples compared with nasopharyngeal swabs, perceived accuracy compared with lateral flow devices (LFDs) and reassurance of test availability while working or studying on campus. Barriers included concerns about privacy while testing, time to and methods of receiving results compared with LFDs and concerns about insufficient uptake in the university community. There was little evidence that the availability of testing on campus changed the behaviour of participants during a period when COVID-19 restrictions were in place. CONCLUSIONS: The provision of free asymptomatic testing for COVID-19 on a university campus was welcomed by participants and the use of saliva-based PCR testing was regarded as more comfortable and accurate than LFDs. Convenience is a key facilitator of participation in regular asymptomatic testing programmes. Availability of testing did not appear to undermine engagement with public health guidelines.

Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy.

Background: Some pregnant smokers try e-cigarettes, but effectiveness and safety of such use are unknown. Objectives: To compare effectiveness and safety of nicotine patches and e-cigarettes in pregnancy. Design: A pragmatic multi-centre randomised controlled trial. Setting: Twenty-three hospitals across England, and a Stop Smoking Service in Scotland. Participants: One thousand one hundred and forty pregnant daily smokers (12-24 weeks' gestation) motivated to stop smoking, with no strong preference for using nicotine patches or e-cigarettes. Interventions: Participants in the e-cigarette arm were posted a refillable e-cigarette device with two 10 ml bottles of tobacco-flavoured e-liquid (18 mg nicotine). Participants in the nicotine patches arm were posted a 2-week supply of 15 mg/16-hour nicotine patches. Supplies were provided for up to 8 weeks. Participants sourced further supplies themselves as needed. Participants in both arms received support calls prior to their target quit date, on the quit date, and weekly for the next 4 weeks. Outcome measures: The primary outcome was validated prolonged abstinence at the end of pregnancy. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included self-reported abstinence at different time points, treatment adherence and safety outcomes. Results: Only 55% of self-reported abstainers mailed back useable saliva samples. Due to this, validated sustained abstinence rates were low (6.8% vs. 4.4% in the e-cigarettes and nicotine patches arms, respectively, risk ratio = 1.55, 95% confidence interval 0.95 to 2.53; Bayes factor = 2.7). In a pre-specified sensitivity analysis that excluded abstainers using non-allocated products, the difference became significant (6.8% vs. 3.6%, risk ratio = 1.93, 95% confidence interval 1.14 to 3.26; Bayes factor = 10). Almost a third of the sample did not set a target quit date and the uptake of support calls was low, as was the initial product use. At end of pregnancy, 33.8% versus 5.6% of participants were using their allocated product in the e-cigarettes versus nicotine patches arm (risk ratio = 6.01, 95% confidence interval 4.21 to 8.58). Regular use of e-cigarettes in the nicotine patches arm was more common than use of nicotine replacement products in the e-cigarette arm (17.8% vs. 2.8%). Rates of adverse events and adverse birth outcomes were similar in the two study arms, apart from participants in the e-cigarette arm having fewer infants with low birthweight (<2500 g) (9.6% vs. 14.8%, risk ratio = 0.65, 95% confidence interval 0.47 to 0.90; Bayes factor = 10.3). Limitations: Low rates of validation reduced the study power. A substantial proportion of participants did not use the support on offer sufficiently to test its benefits. Sample size may have been too small to detect differences in less frequent adverse effects. Conclusions: E-cigarettes were not significantly more effective than nicotine patches in the primary analysis, but when e-cigarettes use in the nicotine patches arm was accounted for, e-cigarettes were almost twice as effective as patches in all abstinence outcomes. In pregnant smokers seeking help, compared to nicotine patches, e-cigarettes are probably more effective, do not pose more risks to birth outcomes assessed in this study and may reduce the incidence of low birthweight. Future work: Routine monitoring of smoking cessation and birth outcomes in pregnant women using nicotine patches and e-cigarettes and further studies are needed to confirm these results. Trial registration: This trial is registered as ISRCTN62025374 and Eudract 2017-001237-65. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 13. See the NIHR Journals Library website for further project information.

Like many other smokers in the UK, some pregnant smokers try to limit or stop smoking with the help of e-cigarettes. It is not known whether this helps with stopping smoking and whether using e-cigarettes has any bad effects on the baby. We recruited 1140 pregnant smokers who wanted to quit. A random half were given nicotine patches, which are commonly used to help smokers quit. The other half were given an e-cigarette. They also received six weekly phone calls to support them in stopping smoking. We then looked at how many in each group stopped smoking by the end of pregnancy. More women stopped smoking in the group that was given an e-cigarette, but the difference was small and could be due to chance. However, some of the women in the nicotine patch group who had successfully stopped smoking were using e-cigarettes rather than patches. When these (and women in the e-cigarette group who used patches) were not counted, e-cigarettes helped almost twice as many women stop smoking than patches. E-cigarettes were better than patches in preventing low birthweight (having babies who weigh less than 2.5 kg). Otherwise, women given patches and those given e-cigarettes (and their babies) had similar numbers of medical complications. For pregnant women who smoke and need help to quit, e-cigarettes are probably more helpful than nicotine patches, and do not pose any additional risks to women or their babies.

Usual care in a multicentre randomised controlled trial of financial incentives for smoking cessation in pregnancy: qualitative findings from a mixed-methods process evaluation.

OBJECTIVES: Financial incentives are recommended by the UK's National Institute for Health and Care Excellence to aid smoking cessation in pregnancy. However, little is known about how implementation contexts might impact on their effectiveness. Variations in smoking cessation support (usual care) for pregnant women who smoke were examined qualitatively as part of a prospective process evaluation of the Cessation in Pregnancy Incentives Trial (CPIT III). DESIGN: Longitudinal case studies of five CPIT III trial sites informed by realist evaluation. SETTING: A stop smoking service (SSS) serving a maternity hospital constituted each case study, located in three UK countries. PARTICIPANTS: Data collection included semistructured interviews with trial participants (n=22), maternity (n=12) and SSS staff (n=17); and site observations and perspectives recorded in fieldnotes (n=85). RESULTS: Cessation support (usual care) for pregnant women varied in amount, location, staff capacity, flexibility and content across sites. SSS staff capacity was important to avoid gaps in support. Colocation and good working relationships between maternity and SSS professionals enabled prioritisation and reinforced the importance of smoking cessation. Sites with limited use of carbon monoxide (CO) monitoring reduced opportunities to identify smokers while inconsistency around automatic referral processes prevented the offer of cessation support. SSS professionals colocated within antenatal clinics were available to women they could not otherwise reach. Flexibility around location, timing and tailoring of approaches for support, facilitated initial and sustained engagement and reduced the burden on women. CONCLUSIONS: Trial sites faced varied barriers and facilitators to delivering cessation support, reflecting heterogeneity in usual care. If financial incentives are more effective with concurrent smoking cessation support, sites with fewer barriers and more facilitators regarding this support would be expected to have more promising trial outcomes. Future reporting of trial outcomes will assist in understanding incentives' generalisability across a wide range of usual care settings. TRIAL REGISTRATION NUMBER: ISRCTN15236311.

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

OBJECTIVE: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. DESIGN: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)). SETTING: Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England. PARTICIPANTS: 944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks' gestation, and notified to the trial team by routine stop smoking services. INTERVENTIONS: Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy. MAIN OUTCOME MEASURES: Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks' gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers. RESULTS: From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born. CONCLUSIONS: The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15236311.

Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial.

Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95-2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14-3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47-0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.

Washout policies in long-term indwelling urinary catheterization in adults: a short version cochrane review.

BACKGROUND: People requiring long-term bladder draining with an indwelling catheter can experience catheter blockage. Regimens involving different solutions can be used to wash out catheters with the aim of preventing blockage. OBJECTIVES: To determine if certain washout regimens (including no washout) are better than others in terms of effectiveness, acceptability, complications, quality of life, and economics for the management of long-term indwelling urinary catheters in adults. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialized Trials Register (searched April 30, 2009), MEDLINE (January 1966 to April 2009), MEDLINE In-Process (April 30, 2009), EMBASE (January 1980 to April 2009), and CINAHL (December 1981 to April 2009). Additionally, we examined all reference lists of identified trials and contacted manufacturers and researchers in the field. SELECTION CRITERIA: All randomized and quasi-randomized trials comparing catheter washout policies (e.g., washout vs. no washout, different washout solutions, frequency, duration, volume, concentration, method of administration) in adults (16 years and above) in any setting (i.e., hospital, nursing/residential home, community) with an indwelling urethral or suprapubic catheter in place for more than 28 days. DATA COLLECTION AND ANALYSIS: Data were extracted by three reviewers independently and compared. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. If the trial data were not fully reported, clarification was sought from the authors. For categorical outcomes, the numbers reporting an outcome were related to the numbers at risk in each group to derive a risk ratio (RR). For continuous outcomes, means, and standard deviations were used to derive weighted mean differences (WMD). No meta-analysis of study results was possible. RESULTS: Five trials met the inclusion criteria involving 242 patients (132 completed) in two cross-over and three parallel-group randomized controlled trials. Only three of the eight comparisons pre-stated in the review protocol were addressed in these trials. Some trials addressed more than one comparison (e.g., washout vs. no washout and one type of washout solution vs. another). The analyses reported for the two cross-over trials were inappropriate as they were based on differences between groups rather than differences within individuals receiving sequential interventions. Two parallel-group trials had limited value: one combined results for suprapubic and urethral catheters and one had data on only four participants. Only one trial was free of significant methodological limitations, but its sample size was small. Three trials compared no washout with one or more washout solution (saline or acidic solutions) and authors tended to conclude no difference in clinical outcomes between washout and no washout. In the one trial which had data of sufficient quality to allow interpretation, no difference was detected between washout and no washout groups in the rate of symptomatic urinary tract infection or time to first catheter change. Three trials compared different types of solution: saline versus acidic solutions (two trials); saline versus acidic solution versus antibiotic solution (one trial). Authors tended to report no difference between different washout solutions but the data were too few to support their conclusions. The one trial which warranted consideration concluded no difference between saline and an acidic solution in terms of symptomatic urinary tract infections or time to first catheter change. CONCLUSIONS: The data from five trials comparing differing washout policies were sparse and trials were generally of poor quality or poorly reported. The evidence was too scant to conclude whether or not washouts were beneficial. Further rigorous, high quality trials with adequate power to detect any benefit from washout rather than no washout being performed are required in the first instance. After that, trials comparing different washout solutions, washout volumes, frequencies/timings, and routes of administration are needed.

A Qualitative Study of Factors Influencing Adherence among Pregnant Women Taking Part in a Trial of E-Cigarettes for Smoking Cessation.

Use of e-cigarettes (vaping) has potential to help pregnant women stop smoking. This study explored factors influencing adherence among participants in the vaping arm of the first trial of vaping for smoking cessation in pregnancy. We conducted semi-structured telephone interviews (n = 28) with women at three-months postpartum. Interviews were analysed using thematic analysis, informed by the Theoretical-Domains Framework, Necessity-Concerns Framework and Perceptions and Practicalities Approach. Interviewees generally reported high levels of vaping. We found that: (1) intervention adherence was driven by four necessity beliefs-stopping smoking for the baby, and vaping for harm reduction, smoking cessation or as a last resort; (2) necessity beliefs outweighed vaping concerns, such as dependence and safety; (3) adherence was linked to four practicalities themes, acting as barriers and facilitators to vaping-device and e-liquid perceptions, resources and support, whether vaping became habitual, and social and environmental factors; and (4) intentional non-adherence was rare; unintentional non-adherence was due to device failures, forgetting to vape, and personal circumstances and stress. Pregnant smokers provided with e-cigarettes, and with generally high levels of vaping, had positive beliefs about the necessity of vaping for smoking cessation which outweighed concerns about vaping. Non-adherence was mainly due to unintentional factors.

Washout policies in long-term indwelling urinary catheterisation in adults.

BACKGROUND: People requiring long-term bladder draining with an indwelling catheter can experience catheter blockage. Regimens involving different solutions can be used to washout catheters with the aim of preventing blockage. OBJECTIVES: To determine if certain washout regimens are better than others in terms of effectiveness, acceptability, complications, quality of life and economics for the management of long-term indwelling urinary catheterisation in adults. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, CINAHL and EMBASE (searches last updated April 2009). Additionally, we examined all reference lists of identified trials. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing catheter washout policies (e.g. washout versus no washout, different washout solutions, frequency, duration, volume, concentration, method of administration) in adults (16 years and above) in any setting (i.e. hospital, nursing/residential home, community) with an indwelling urethral or suprapubic catheter for more than 28 days. DATA COLLECTION AND ANALYSIS: Data were extracted by three reviewers independently and compared. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. If the data in trials were not fully reported, clarification was sought from the authors. For categorical outcomes, the numbers reporting an outcome were related to the numbers at risk in each group to derive an risk ratio (RR). For continuous outcomes, means and standard deviations were used to derive weighted mean differences (WMD). No meta-analysis of study results was possible. MAIN RESULTS: Five trials met the inclusion criteria involving 242 patients (132 completed) in two cross-over and three parallel-group randomised controlled trials. Only three of the eight pre-stated comparisons were addressed in these trials. Some trials addressed more than one comparison (e.g. washout versus no washout and one type of washout solution versus another). The analyses reported for the two cross-over trials were inappropriate as they were based on differences between groups rather than differences within individuals receiving sequential interventions. Two parallel-group trials had limited value: one combined results for suprapubic and urethral catheters and one had data on only four participants. Only one trial was free of significant methodological limitations, but its sample size was small.Three trials compared no washout with one or more washout solution (saline or acidic solutions) and authors tended to conclude no difference in clinical outcomes between washout and no washout. In the one trial which had data of sufficient quality to allow interpretation, no difference was detected between washout and no washout groups in the rate of symptomatic urinary tract infection or time to first catheter change. Three trials compared different types of solution: saline versus acidic solutions (two trials); saline versus acidic solution versus antibiotic solution (one trial). Authors tended to report no difference between different washout solutions but the data were too few to support their conclusions. The one trial which warranted consideration concluded no difference between saline and an acidic solution in terms of symptomatic urinary tract infections or time to first catheter change. AUTHORS' CONCLUSIONS: The data from five trials comparing differing washout policies were sparse and trials were generally of poor quality or poorly reported. The evidence was too scanty to conclude whether or not washouts were beneficial. In the first instance we require further rigorous, high quality trials with adequate power to detect any benefit from washout being performed as opposed to none. Then trials comparing different washout solutions, washout volumes, frequencies/timings and routes of administration are needed.

A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

INTRODUCTION: Smoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%-23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to sudden infant death syndrome, respiratory diseases and increased likelihood of taking up smoking. These risks impact the long-term health of the child with associated increase in health costs. Emerging evidence suggests that offering financial incentives to pregnant women to quit is highly cost effective.This protocol describes the economic evaluation of a multi-centre randomised controlled trial (Cessation in Pregnancy Incentives Trial III, CPIT III) designed to establish whether offering financial incentives, in addition to usual care, is effective and cost effective in helping pregnant women to quit. METHODS AND ANALYSIS: The economic evaluation will identify, measure and value resource use and outcomes from CPIT III, comparing participants randomised to either usual care or usual care plus up to £400 financial incentives. Within-trial and long-term analyses will be conducted from a National Health Service and Personal Social Services perspective; the outcome for both analyses will be quality adjusted life-years measured using EQ-5D-5L. Patient level data collected during the trial will be used for the within-trial analysis, with an additional outcome of cotinine validated quit rates at 34-38 weeks gestation and 6 months postpartum. The long-term model will be informed by data from the trial and published literature. ETHICS AND DISSEMINATION: TRIAL REGISTRATION NUMBER: ISRCTN15236311; Pre-results (https://doi.org/10.1186/ISRCTN15236311).

Electronic cigarettes as a smoking cessation aid for patients with cancer: beliefs and behaviours of clinicians in the UK.

OBJECTIVES: To explore UK clinicians' beliefs and behaviours around recommending e-cigarettes as a smoking cessation aid for patients with cancer. DESIGN: Cross-sectional online survey. SETTING: England, Wales, Scotland and Northern Ireland. PARTICIPANTS: Clinicians involved in the care of patients with cancer. PRIMARY AND SECONDARY OUTCOMES: Behavioural Change Wheel capability, opportunity and motivation to perform a behaviour, knowledge, beliefs, current practice around e-cigarettes and other smoking cessation practices. METHOD: Clinicians (n=506) completed an online survey to assess beliefs and behaviours around e-cigarettes and other smoking cessation practices for patients with cancer. Behavioural factors associated with recommending e-cigarettes in practice were assessed. RESULTS: 29% of clinicians would not recommend e-cigarettes to patients with cancer who continue to smoke. Factors associated with recommendation include smoking cessation knowledge (OR 1.56, 95% CI 1.01 to 2.44) and e-cigarette knowledge (OR 1.64, 95% CI 1.06 to 2.55), engagement with patients regarding smoking cessation (OR 2.12, 95% CI 1.12 to 4.03), belief in the effectiveness of e-cigarettes (OR 2.36 95% CI 1.61 to 3.47) and belief in sufficient evidence on e-cigarettes (OR 2.08 95% CI 1.10 to 4.00) and how comfortable they felt discussing e-cigarettes with patients (OR 1.57 95% CI 1.04 to 2.36). CONCLUSION: Many clinicians providing cancer care to patients who smoke do not recommend e-cigarettes as a smoking cessation aid and were unaware of national guidance supporting recommendation of e-cigarettes as a smoking cessation aid.

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial.

BACKGROUND: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? METHODS: The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, < 24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK? DISCUSSION: This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

Attitudes to E-Cigarettes and Cessation Support for Pregnant Women from English Stop Smoking Services: A Mixed Methods Study.

Smoking in pregnancy remains a public health problem. In the UK e-cigarettes are the most popular aid to quitting smoking outside of pregnancy, but we don't know the extent of e-cigarette use in pregnancy or how English Stop Smoking Services (SSS) respond to pregnant women who vape. In 2015 we surveyed SSS managers about cessation support for pregnant women and responses to clients who vaped. Subsequently we interviewed a sub-sample of managers to seek explanations for the SSS' position on e-cigarettes; interviews were thematically analysed. Survey response rate was 67.8% (72/106); overall managers reported 2.2% (range 1.4⁻4.3%) of pregnant clients were using e-cigarettes. Most SSS reported supporting pregnant women who already vaped, but would not recommend e-cigarette use; for women that were still smoking and not using e-cigarettes, 8.3% of SSS were likely/very likely to advise using e-cigarettes, with 56.9% of SSS unlikely/very unlikely to advise using them. Fifteen respondents were interviewed; interviewees were generally positive about the potential of e-cigarettes for cessation in pregnancy although concerns about perceived lack of evidence for safety were expressed and most wanted research on this. Clear guidance on e-cigarette use informed by pregnancy specific research will assist SSS to provide consistent evidence-based support.

WISECARE+: Results of a European study of a nursing intervention for the management of chemotherapy-related symptoms.

While the use of chemotherapy has significantly improved survival rates, the symptoms associated with chemotherapy remain a major burden for patients. Preventing or appropriately managing side effects significantly improves patients' functional status and quality of life, ultimately leading to greater patient acceptance of chemotherapy. However, symptom assessment and management are fraught with difficulties such as poor patient recall, retrospective assessment conducted by clinicians and lack of appropriate, clinically relevant and patient friendly symptom assessment and management tools. Furthermore the differences between clinician and patient perceptions of stresses and distress during chemotherapy are well recognised. This study aimed to evaluate the impact of a nursing intervention incorporating structured symptom assessment and management, facilitated by information technology, on chemotherapy-related symptoms, nausea, vomiting, fatigue and mucositis. This pan-European study, involved 8 clinical sites from Belgium, Denmark, England, Ireland and Scotland. Adults (n=249) receiving first line chemotherapy for breast, lung, ovarian or colorectal cancer, osteosarcoma, acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) or lymphoma were recruited to the study. Patients completed daily symptom assessment questionnaires for 14 days following consecutive cycles of chemotherapy. Symptom outcomes were compared before and after the introduction of the intervention with positive impact on patients' experiences of nausea, vomiting and oral problems. Fatigue was not significantly improved.

Sitting vs standing during screening mammography.

OBJECTIVE: The aim of this randomized controlled trial was to compare outcomes of standing vs seated mammography. METHODS: Five hundred forty women were assessed for ease of getting into position, comfort and pain using visual analog scales. Blinded, independent assessment of film quality and length of time for the mammography procedure were additional outcomes. RESULTS: Among women with previous experience of screening mammography, those who were seated had significantly less difficulty getting into position than those who stood, and they also reported less discomfort. There were no significant differences in these outcomes for the group of women having their first screening mammogram. There was no difference in reported pain between the seated and standing groups, either for first-time or experienced patients. For first-time patients there was a significantly higher percentage of inadequate films in the seated group compared with the standing group. There was no significant difference between groups in the duration of the procedure, either for first-time or experienced patients. CONCLUSION: In summary, there were benefits of sitting during mammography for women with previous experience of mammography in terms of improved ease of positioning and comfort. In terms of film quality, there were disadvantages associated with seated mammography for first-time patients, although these might not be clinically significant.

Barriers and facilitators to smoking cessation in pregnancy and in the post-partum period: The health care professionals' perspective.

OBJECTIVES: Health care professionals and the health care environment play a central role in protecting pregnant and post-partum women and their infants from smoking-related harms. This study aimed to better understand the health professional's perspective on how interactions between women, health care professionals, and the environment influence how smoking is managed. DESIGN: Semi-structured interviews and focus groups. METHODS: Data were from 48 health care staff involved in antenatal or post-partum 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 health care context and the beliefs and behaviour of pregnant or post-partum smokers. Organizational 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. Interpersonal level: Protection of client-professional relationships often inhibited frank discussions about smoking, and weak interservice relationships affected SSS referral motivation and quality. Individual level: Professionals felt community midwives had primary responsibility for managing smoking, although midwives felt underskilled doing this. Midwives' perceived priority for addressing smoking was influenced by the demands from unrelated organizational initiatives. CONCLUSIONS: Opportunities to improve clinical support for pregnant smokers exist at organizational, interservice, and health care professional levels. Interactions between levels reflect the importance of simultaneously addressing different level-specific barriers to smoking cessation in pregnancy. Statement of contribution What is already known on this subject? Few health care professionals discuss smoking cessation support with pregnant or post-partum women. Identified health care professional-related barriers to supporting pregnant and post-partum women to stop smoking include deficits in knowledge and confidence, perceived lack of time, and concerns about damaging client relationships. There is currently a gap in understanding regarding the barriers and facilitators to supporting this group and how interactions between the health care environment and health care professionals influence the way smoking is addressed. What does this study add? This study identifies modifiable factors that can influence cessation support delivery to pregnant and post-partum women. These factors are mapped across organizational, interpersonal, and individual health care professional levels. Service structure, communication pathways, and policies appear to influence what cessation support is offered. Interpersonal and individual factors influence how this support is delivered.