Intensive management from diagnosis improves HbA1c at 12 months post-diagnosis: results from a prospective cohort study in children with newly diagnosed type 1 diabetes.

AIMS: To examine the impact of intensive management of type 1 diabetes (T1D) from diagnosis on HbA1c 12 months from diagnosis. METHODS: HbA1c measured 12 months after diagnosis for 70 consecutively newly diagnosed children with T1D following implementation of an intensive management protocol was compared with 70 children consecutively diagnosed immediately pre-implementation. Intensive management involved carbohydrate counting and flexible insulin dosing from first meal with subcutaneous insulin, targeted blood glucose levels from 4-8mmol/L irrespective of time of day, avoidance of twice daily insulin regimen and promotion of continuous glucose monitoring (CGM). HbA1c, diabetes technology use and insulin regimen at 12 months post-diagnosis were compared. RESULTS: The post-intensive management implementation cohort had an improved mean HbA1c of 58.2±15.3mmol/mol vs 63.7±10.7mmol/mol at 12 months (p=0.014). The proportion of young people with diabetes meeting a target HbA1c of <53mmol/mol at 12 months improved from 11% to 40% (p=<0.001). There was a reduction of twice daily insulin regimen from 66% to 11% (p=<0.001), and increased CGM use from 57% to 76% (p=0.02). CONCLUSION: Intensive management when implemented with consistent messaging from the multi-disciplinary team resulted in clinic-wide improvements in HbA1c and the proportion meeting HbA1c targets.

Psychological and psychosocial determinants of COVID Health Related Behaviours (COHeRe): An evidence and gap map.

Background: The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has resulted in illness, deaths and societal disruption on a global scale. Societies have implemented various control measures to reduce transmission of the virus and mitigate its impact. Individual behavioural changes are crucial to the successful implementation of these measures. Common recommended measures to limit risk of infection include frequent handwashing, reducing the frequency of social interactions and the use of face coverings. It is important to identify those factors that can predict the uptake and maintenance of these protective behaviours. Objectives: We aimed to identify and map the existing evidence (published and unpublished) on psychological and psychosocial factors that determine uptake and adherence to behaviours aimed at reducing the risk of infection or transmission of COVID-19. Search Methods: Our extensive search included electronic databases (n = 12), web searches, conference proceedings, government reports, other repositories including both published peer reviewed, pre-prints and grey literature. The search strategy was built around three concepts of interest including (1) context (terms relating to COVID-19), (2) behaviours of interest and (3) terms related to psychological and psychosocial determinants of COVID Health-Related Behaviours and adherence or compliance with recommended behaviours, to capture both malleable and non-malleable determinants (i.e. determinants that could be changed and those that could not). Selection Criteria: This Evidence and Gap Map (EGM) includes all types of studies examining determinants of common recommended behaviours aimed at mitigating human-to-human spread of COVID-19. All potential malleable and non-malleable determinants of one or more behaviours are included in the map. As part of the mapping process, categories are used to group determinants. The mapping categories were based on a previous rapid review by Hanratty 2021. These include: 'behaviour', 'cognition', 'demographics', 'disease', 'emotions', 'health status', 'information', 'intervention', and 'knowledge'. Those not suitable for categorisation in any of these groups are included in the map as 'other' determinants. Data Collection and Analysis: Results were imported to a bibliographic reference manager where duplications of identical studies gathered from multiple sources were removed. Data extraction procedures were managed in EPPI-Reviewer software. Information on study type, population, behaviours measured and determinants measured were extracted. We appraised the methodological quality of systematic reviews with AMSTAR-2. We did not appraise the quality of primary studies in this map. Main Results: As of 1 June 2022 the EGM includes 1034 records reporting on 860 cross-sectional, 68 longitudinal, 78 qualitative, 25 reviews, 62 interventional, and 39 other studies (e.g., mixed-methods approaches). The map includes studies that measured social distancing (n = 487), masks and face coverings (n = 382), handwashing (n = 308), physical distancing (n = 177), isolation/quarantine (n = 157), respiratory hygiene/etiquette (n = 75), cleaning surfaces (n = 59), and avoiding touching the T-zone (n = 48). There were 333 studies that assessed composite measures of two or more behaviours. The largest cluster of determinants was 'demographics' (n = 730 studies), followed by 'cognition' (n = 496 studies) and determinants categorised as 'other' (n = 447). These included factors such as 'beliefs', 'culture' and 'access to resources'. Less evidence is available for some determinants such as 'interventions' (n = 99 studies), 'information' (n = 101 studies), and 'behaviour' (149 studies). Authors' Conclusions: This EGM provides a valuable resource for researchers, policy-makers and the public to access the available evidence on the determinants of various COVID-19 health-related behaviours. The map can also be used to help guide research commissioning, by evidence synthesis teams and evidence intermediaries to inform policy during the ongoing pandemic and potential future outbreaks of COVID-19 or other respiratory infections. Evidence included in the map will be explored further through a series of systematic reviews examining the strength of the associations between malleable determinants and the uptake and maintenance of individual protective behaviours.

Type 1 diabetes diagnosed before age 15 years in Canterbury, New Zealand: A 50 year record of increasing incidence.

OBJECTIVE: To describe the epidemiology of pediatric type 1 diabetes over 50 years in Canterbury, New Zealand. Further, to explore variation in case presentation according to age, gender, ethnicity, urban/rural character, socio-economic deprivation and immunogenetic features. RESEARCH DESIGN AND METHODS: Prospective ascertainment of cases commenced in 1982, and incident cases presenting 1970-1982 were ascertained retrospectively from clinical records. Eligibility criteria included diagnosis of type 1 diabetes by a physician and commencement of insulin therapy at diagnosis and age less than 15 years. Data collection included name, hospital number, date of birth, date of diagnosis, and date of initiation of insulin treatment. Full address at diagnosis was assigned an urban-rural classification, and a deprivation score. HLA-DQ susceptibility alleles and diabetes associated autoantibodies were determined. RESULTS: The incidence of type 1 diabetes increased more than 5-fold (3.9% per annum) over 50 years for the entire cohort. The mean for 5-year periods, starting from 1970, increased from 5.3 to 29.0 cases per 100,000 person years. Incidence was greatest in the 10-14 year age group. The cohort is predominantly European (89.4%), but there has been an increase in cases identifying as New Zealand Maori in the last three decades. Weak evidence was found for reduced incidence of type 1 diabetes in rural regions (adjusted IRR = 0.70, 95%CI 0.52 to 0.91, p = 0.011). CONCLUSIONS: The incidence of type 1 diabetes in children aged less than 15 years continues to increase with time. Incidence was significantly affected by age, ethnicity, and urban/rural characterization of address at diagnosis.

Psychiatric mental health nursing in the international year of the nurse and COVID-19: One hospital's perspective on resilience and innovation - Past, present and future.

In the International Year of the Nurse, we are in the midst of a global pandemic. Historically, nurses have been at the forefront of crises influencing standards of care and public health policy. Managing psychiatric patients during the current COVID-19 pandemic has challenged the psychiatric nurses' role within the therapeutic milieu fostering innovative practices to meet patient needs. Our behavioral health center met the challenges with resilience, creativity and commitment. The next challenge is to learn from experience. Building on innovative technology opens the window to new models of care. Understanding resilience is critical to preparing for the next crisis.

Vitamin D supplementation for cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is a genetic disorder with multiorgan effects. In a subgroup with pancreatic insufficiency malabsorption of the fat soluble vitamins (A, D, E, K) may occur. Vitamin D is involved in calcium homeostasis and bone mineralisation and may have extraskeletal effects. This review examines the evidence for vitamin D supplementation in cystic fibrosis. OBJECTIVES: To assess the effects of vitamin D supplementation on the frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity in the cystic fibrosis population. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search: 08 July 2013. SELECTION CRITERIA: Randomised and quasi-randomised controlled studies of vitamin D supplementation compared to placebo in the cystic fibrosis population regardless of exocrine pancreatic function. DATA COLLECTION AND ANALYSIS: Both authors independently assessed the risk of bias of each included study and extracted outcome data (from published study information) for assessment of bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events. MAIN RESULTS: Six studies (239 participants) are included, although only three studies provided data from 69 adults and children with cystic fibrosis for analysis. One study compared a single high dose of vitamin D (250,000 IU) to placebo at the time of hospital admission with a respiratory exacerbation in 30 pancreatic insufficient adults with cystic fibrosis. The second study compared supplemental 800 international units (IU) vitamin D and placebo for 12 months in 30 osteopenic pancreatic insufficient adults; both groups continued 900 IU vitamin D daily. The third study compared supplemental 1 g calcium alone, 1600 IU vitamin D alone, 1600 IU vitamin D and 1 g calcium and placebo in a double-blind randomised cross-over study; only nine children who completed both vitamin D and placebo groups after six-months supplementation and a three-month washout period are included; pancreatic sufficiency or disease status of participants are not defined. The studies are not directly comparable due to differences in supplementation, outcome reporting and possibly participant characteristics (e.g. severity of lung disease, growth and nutrition, pancreatic sufficiency).The only outcome for which we could combine data from more than two studies was 25-hydroxyvitamin D levels; patients receiving vitamin D supplementation had significantly higher levels, mean difference 7.24 ng/ml (95% confidence interval 5.01 to 9.46). However, ironically one study reported 1,25(OH)2D with levels significantly favouring the placebo group, mean difference -30.30 pmol/ml (95% confidence interval -59.89 to -0.71). Bone mineral density was measured in two studies; both described no significant change between groups. There were no adverse events in any study.The remaining three studies are published as abstracts only and did not provide data for analysis. These abstracts include: a report of pre-intervention data in a study comparing daily calcitriol (0.25 or 0.5 micrograms) with placebo in pancreatic insufficient children and young adults; an interim report of a double-blind randomised control study comparing 5000 IU vitamin D daily for 12 weeks during winter in 67 adult cystic fibrosis patients; and a comparison of the effect of three months of vitamin D supplementation (dose not specified) with placebo on bone mineral density in 42 children with cystic fibrosis and low bone mineral density.Risk of bias was highly variable between all studies. Only one study had a low risk of bias for the five main criteria (random sequence generation, allocation, blinding, attrition and reporting). The rest of the studies had unclear or high risks of bias. Two studies had a low risk of bias for blinding and another two studies for attrition bias. In the studies published as abstracts, assessment of the risks of bias was uncertain in many aspects. AUTHORS' CONCLUSIONS: In patients receiving vitamin D supplementation, 25-hydroxyvitamin D levels are significantly higher. However, there is no evidence of clinical benefit or harm in the limited number of small-sized published studies. Adherence to relevant cystic fibrosis guidelines on vitamin D supplementation should be considered until further evidence is available.

Developing the evidence base for addressing inequalities and smoking in the United Kingdom.

AIMS: Smoking is an increasing cause of health inequalities in high-income countries. This supplement describes pilot projects set up in England to develop and test pathways to ensure that disadvantaged groups, where smoking is frequently the norm, are reached, encouraged and supported to stop their tobacco use. Target groups were: smokers attending centres set up for highly deprived parents; smokers with serious and enduring mental illness; pregnant smokers; prisoners/other offenders who smoked; South Asian tobacco chewers; and recent quitters from 'routine and manual' occupational groups. METHODS: Commonalities observed across the six projects are summarized, alongside recommendations for implementation. RESULTS: A significant barrier to implementation was the lack of mandatory identification of tobacco users across primary, secondary and community health-care settings and routine use of expired air carbon monoxide monitoring, particularly for high-risk groups. Appropriate use of financial incentives and national guidance is probably necessary to achieve both this and the adoption of 'joined-up' tobacco dependence treatment pathways for these target groups. Further research is needed on the impact of 'opt out' pathways: while resulting in increased referral rates, success rates were lower. In general, smoking cessation service targets were a barrier to implementation. Flexibility and tailoring of interventions were required and most projects trained those already working in relevant settings, given their greater understanding of target groups. Mandatory training of all frontline health-care staff was deemed desirable. CONCLUSIONS: Implementing the findings of these projects will require resources, for training, incentivizing health-care workers and further research. However, continuing with the status quo may result in sustained tobacco use health inequalities for the foreseeable future.

Implementation of routine biochemical validation and an 'opt out' referral pathway for smoking cessation in pregnancy.

AIMS: To introduce an 'opt out' referral pathway for smoking cessation in pregnancy and to compare different methods for identifying pregnant smokers in maternity care. DESIGN: Pilot study that analysed routine data from maternity and smoking cessation services with biochemical validation of smoking status. SETTING: Dudley and South Birmingham, England. PARTICIPANTS: A total of 3712 women who entered the referral pathway-1498 in Dudley and 2214 in South Birmingham. MEASUREMENTS: Routine monitoring data on smoking at maternity booking, referral to smoking cessation services, number of women who set quit dates set and short-term (4-week) self-report smoking status. Comparison of self-report, carbon monoxide (CO)-validated and urinary cotinine-validated smoking status for a subsample (n = 1492) of women at maternity booking. FINDINGS: In Dudley 27% of women who entered the opt out referral pathway were identified as smokers following CO testing. Of those referred to the smoking cessation services, 19% reported stopping smoking at 4-week follow-up. In South Birmingham 17% were smokers at booking, with 5% of those referred recorded as non-smokers at 4 weeks. The number of women quitting did not increase during the study when compared with the previous year, despite higher referral rates in both areas. An optimum cut-off CO measurement of 4 parts per million (p.p.m.) was identified for sensitivity and specificity. CONCLUSION: The introduction of an opt out referral pathway between maternity and stop smoking services resulted in more women being referred for support to quit but not higher numbers of quitters, suggesting that automatic referral may include women who are not motivated to stop and who may not engage with services. Routine carbon monoxide monitoring introduced as part of a referral pathway should involve a cut-off of 4 p.p.m. to identify smoking in pregnancy.

Vitamin D supplementation for cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is a genetic disorder with multiorgan effects. In a subgroup with pancreatic insufficiency malabsorption of the fat soluble vitamins (A, D, E, K) may occur. Vitamin D is involved in calcium homeostasis and bone mineralisation and may have extraskeletal effects. This review examines the evidence for vitamin D supplementation in CF. OBJECTIVES: To assess the effects of vitamin D supplementation on the frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity in the CF population. SEARCH METHODS: We searched the Cochrane CF and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Most recent search: 15 February 2012. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of vitamin D supplementation compared to placebo in the CF population regardless of exocrine pancreatic function. DATA COLLECTION AND ANALYSIS: Both authors independently assessed the 'risk of bias' of each included trial and extracted outcome data (from published trial information) for assessment of bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events. MAIN RESULTS: Three studies are included, although only data from two were available (41 adults and children with CF). One of these studies compared supplemental 800 international units (IU) vitamin D and placebo for 12 months in 30 osteopenic pancreatic insufficient adults; both groups continued 900 IU vitamin D daily. The other (abstract only) compared supplemental 1g calcium alone, 1600 IU vitamin D alone, 1600 IU vitamin D and 1g calcium and placebo in a double-blind randomised cross-over trial; only 11 children (vitamin D and placebo groups) after six-months supplementation are included; inclusion criteria, pancreatic sufficiency or disease status of participants are not defined. There were no significant differences in primary or secondary outcomes in either study. The studies are not directly comparable due to differences in supplementation, outcome reporting and possibly participant characteristics (eg severity of lung disease, growth and nutrition, pancreatic sufficiency). There were no adverse events in either study. The third study (abstract only) compared daily calcitriol (0.25 or 0.5 micrograms) with placebo in pancreatic insufficient children and young adults, only pre-intervention data were available. AUTHORS' CONCLUSIONS: There is no evidence of benefit or harm in the limited number of small-sized published trials. Adherence to relevant CF guidelines on vitamin D should be considered until further evidence is available.

Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial.

OBJECTIVE: To compare the effects of free nicotine replacement therapy or proactive telephone counselling in addition to standard smoking cessation support offered through a telephone quitline. DESIGN: Parallel group, 2 × 2 factorial, randomised controlled trial. SETTING: National quitline, England. PARTICIPANTS: 2591 non-pregnant smokers aged 16 or more residing in England who called the quitline between February 2009 and February 2010 and agreed to set a quit date: 648 were each randomised to standard support, proactive support, or proactive support with nicotine replacement therapy, and 647 were randomised to standard support with nicotine replacement therapy. INTERVENTIONS: Two interventions were offered in addition to standard support: six weeks' nicotine replacement therapy, provided free, and proactive counselling sessions (repeat telephone calls from, and interaction with, cessation advisors). MAIN OUTCOME MEASURES: The primary outcome was self reported smoking cessation for six or more months after the quit date. The secondary outcome was cessation validated by exhaled carbon monoxide measured at six or more months. RESULTS: At six months, 17.7% (n = 229) of those offered nicotine replacement therapy reported smoking cessation compared with 20.1% (n = 261) not offered such therapy (odds ratio 0.85, 95% confidence interval 0.70 to 1.04), and 18.2% (n = 236) offered proactive counselling reported smoking cessation compared with 19.6% (n = 254) offered standard support (0.91, 0.75 to 1.11). Data validated by carbon monoxide readings changed the findings for nicotine replacement therapy only, with smoking cessation validated in 6.6% (85/1295) of those offered nicotine replacement therapy compared with 9.4% (122/1296) not offered such therapy (0.67, 0.50 to 0.90). CONCLUSIONS: Offering free nicotine replacement therapy or additional (proactive) counselling to standard helpline support had no additional effect on smoking cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT00775944.

Evaluation of a drop-in rolling-group model of support to stop smoking.

AIMS: To assess longer-term outcomes of a drop-in rolling-group model of behavioural support for smoking cessation and the factors that influence cessation outcomes. DESIGN: Prospective observational cohort study. SETTING: Fag Ends NHS Stop Smoking Service in Liverpool and Knowsley, UK. PARTICIPANTS: A total of 2585 clients, aged 16 or over, setting a quit date. MEASUREMENTS: Routine monitoring data were collected from Fag Ends service users and were supplemented by survey data on socio-economic circumstances, smoking-related behaviour and self-report and carbon monoxide (CO)-validated smoking status at 52-week follow-up. FINDINGS: The CO-validated prolonged abstinence rate at 52 weeks for smokers attending the groups was 5.6%, compared with 30.7% at 4 weeks (a relapse rate of 78.2%). The sample was particularly disadvantaged: 68% resided in the most deprived decile of the English Index of Multiple Deprivation. Higher socio-economic status within the sample was a predictor of quitting. Other predictors of long-term cessation in multivariate analysis included older age, being female, lower levels of nicotine dependence, having a live-in partner, stronger determination to quit and use of varenicline versus other medication. CONCLUSIONS: A wholly state-reimbursed clinical stop-smoking service providing behavioural support and medication in a region of high economic and social disadvantage has reached a significant proportion of the smoking population. Long-term success rates are lower than are found typically in clinical trials, but higher than would be expected if the smokers were to try and quit unaided. Research is needed into how to improve on the success rates achieved.

One-year outcomes and a cost-effectiveness analysis for smokers accessing group-based and pharmacy-led cessation services.

INTRODUCTION: An observational study examining 1-year follow-up of clients of two National Health Service smoking cessation services in Glasgow was used to inform a cost-effectiveness analysis. One service involved 7 weeks of group-based support (n = 411) and the other consisted of up to 12 weeks of one-to-one counseling with pharmacists (n = 1,374). Pharmacological aids to quitting (e.g., nicotine replacement therapy) were available to all clients. METHODS: Quit rates were calculated for each service at 52 weeks after the quit date, and these were used for an economic evaluation of both the annual and the lifetime cost-effectiveness of the pharmacy- and group-based interventions in comparison with a baseline "self-quit" scenario. The annual cost-effectiveness model established the incremental cost per 52-week quitter, while a Markov model was developed for the lifetime analysis to estimate the potential lifetime outcomes in terms of cost per quality-adjusted life years (QALY) gained, to account for the benefits quitters will receive in terms of extended life years and improvements in quality of life from smoking cessation. RESULTS: The proportion of carbon monoxide-validated quitters from both services combined fell from 22.5% at 4-week follow-up to 3.6% at 52 weeks. The group service achieved a higher quit rate (6.3%) than the pharmacy service (2.8%) but was more intensive and required greater overhead costs. The lifetime analysis resulted in an incremental cost per QALY of £4,800 for the group support and £2,600 for pharmacy one-to-one counseling. CONCLUSIONS: Despite disappointing 1-year quit rates, both services were considered to be highly cost-effective.

Vitamin D supplementation for cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is a genetic disorder with multiorgan effects. In a subgroup with pancreatic insufficiency malabsorption of the fat soluble vitamins (A, D, E, K) may occur. Vitamin D is involved in calcium homeostasis and bone mineralisation and may have extraskeletal effects. This review examines the evidence for vitamin D supplementation in CF. OBJECTIVES: To assess the effects of vitamin D supplementation on the frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity in the CF population. SEARCH STRATEGY: We searched the Cochrane CF and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Most recent search: 09 June 2009. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of vitamin D supplementation compared to placebo in the CF population regardless of exocrine pancreatic function. DATA COLLECTION AND ANALYSIS: Both authors independently assessed the 'risk of bias' of each included trial and extracted outcome data (from published trial information) for assessment of bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events. MAIN RESULTS: Three studies are included, although only data from two were available (41 adults and children with CF). One of these studies compared supplemental 800 international units (IU) vitamin D and placebo for 12 months in 30 osteopenic pancreatic insufficient adults; both groups continued 900 IU vitamin D daily. The other (abstract only) compared supplemental 1g calcium alone, 1600 IU vitamin D alone, 1600 IU vitamin D and 1g calcium and placebo in a double-blind randomised cross-over trial; only 11 children (vitamin D and placebo groups) after six-months supplementation are included; inclusion criteria, pancreatic sufficiency or disease status of participants are not defined. There were no significant differences in primary or secondary outcomes in either study. The studies are not directly comparable due to differences in supplementation, outcome reporting and possibly participant characteristics (eg severity of lung disease, growth and nutrition, pancreatic sufficiency). There were no adverse events in either study. The third study (abstract only) compared daily calcitriol (0.25 or 0.5 micrograms) with placebo in pancreatic insufficient children and young adults, only pre-intervention data were available. AUTHORS' CONCLUSIONS: There is no evidence of benefit or harm in the limited number of small-sized published trials. Adherence to relevant CF guidelines on vitamin D should be considered until further evidence is available.

Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial.

BACKGROUND: Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will investigate whether or not proactive telephone support for smoking cessation, delivered through the National Health Service (NHS) Smoking Helpline is more effective or cost-effective than reactive support. It will also investigate whether or not providing nicotine replacement therapy (NRT), in addition to telephone counselling, has an adjunctive impact on smoking cessation rates and whether or not this is cost effective. METHODS: This will be a parallel group, factorial design RCT, conducted through the English national NHS Smoking Helpline which is run from headquarters in Glasgow. Participants will be smokers who call the helpline from any location in England and who wish to stop smoking. If 644 participants are recruited to four equally-sized trial groups (total sample size = 2576), the trial will have 90% power for detecting a treatment effect (Odds Ratio) of 1.5 for each of the two interventions: i) proactive versus reactive support and ii) the offer of NRT versus no offer. The primary outcome measure for the study is self-reported, prolonged abstinence from smoking for at least six months following an agreed quit date. A concurrent health economic evaluation will investigate the cost effectiveness of the two interventions when delivered via a telephone helpline. DISCUSSION: The PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation.

A comparison of the effectiveness of group-based and pharmacy-led smoking cessation treatment in Glasgow.

AIM: To compare the characteristics and outcomes of users accessing pharmacy and group-based smoking treatment. DESIGN: Observational study of administrative information linked with survey data. SETTING: Glasgow, Scotland. PARTICIPANTS: A total of 1785 service users who set a quit date between March and May 2007. INTERVENTION: Smoking treatment services based in pharmacies providing one-to-one support, and in the community offering group support. MEASUREMENTS: Routine monitoring data included information about basic demographic characteristics, deprivation category of residence, nature of intervention and smoking status at 4-week follow-up determined by carbon monoxide (CO) readings < or = 10. These data were supplemented by information about socio-economic status and smoking-related behaviours obtained from consenting service recipients by treatment advisers. FINDINGS: In the pharmacy-based service 18.6 % of users (n = 1374) were CO-validated as a quitter at 4 weeks, compared with 35.5 % (n = 411) in the group-based service. In a multivariate model, restricted to participants (n = 1366) with data allowing adjustment for socio-demographic and behavioural characteristics and including interaction terms, users who accessed the group-based services were almost twice as likely (odds ratio 1.980; confidence interval 1.50-2.62) as those who used pharmacy-based support to have quit smoking at 4-week follow-up. CONCLUSIONS: Specialist-led group-based services appear to have higher quit rates than one-to-one services provided by pharmacies but the pharmacy services treat many more smokers. More research is needed to determine what can be done to bring the success rates of pharmacy services up to those of specialist-led groups and how to expand access to group-based services.

Implementing a national treatment service for dependent smokers: initial challenges and solutions.

BACKGROUND: Before 1999, few treatment services for nicotine-addicted smokers existed in England. When national treatment services were introduced, those responsible for setting them up liaised closely with primary care health services. Setting up an entirely new national service, treating a new category of patient (smokers motivated to stop) was an ambitious aim and this paper documents the problems encountered in the early stages of this process. OBJECTIVES: To describe the principal challenges encountered and solutions employed by those setting up the services during the initial period of smoking cessation service implementation. METHODS: Qualitative, semistructured interviews with 50 smoking cessation staff in two former English health regions conducted in autumn 2001. FINDINGS: Two principal factors which slowed the initial development of smoking cessation services were: (i) the lack of a work-force with experience in smoking cessation methods and (ii) the fact that services were set up outside existing primary and secondary care health services in England. As few training courses in smoking cessation were available, many services provided their own in-house training for staff appointed as smoking cessation advisers. Consequently, senior service staff devoted a lot of effort to training new staff which meant that they had less time to spend on other important tasks which were necessary for service implementation. Smoking cessation services needed to develop relationships with primary care health services in order to generate referrals and find venues for the delivery of smoking cessation interventions. Liaising with primary care physicians was time-consuming, however, and some primary care physicians were opposed to the ideas that service staff had for the interface between primary care and smoking cessation services. As new smoking cessation services were not set up within existing primary or secondary health care services, service staff had to spend large amounts of time on this process of negotiation and overcoming scepticism from some primary health care physicians. CONCLUSIONS: If smoking cessation services are set up in other countries, rapid implementation would be facilitated by ensuring that adequate numbers of health professionals trained in smoking cessation methods are available to staff services. Additionally, locating new smoking cessation services within existing health providers' services may speed up service implementation, but this option may not suit all health systems.

Delivering the English smoking treatment services.

BACKGROUND: This paper describes how smoking treatment services in England were delivered beyond the initial set-up phase and explores key factors affecting their development. Services were expected to treat smokers in line with the evidence-base and were issued with government guidance regarding the type of interventions that should be offered. One factor complicating this was the issue of service funding. Funding was initially issued for a 3-year period and although this was extended on two occasions, these extensions were both announced close to the end of funding periods. OBJECTIVES: To critically assess key elements in the delivery of the English cessation services, including the nature of treatments offered and the impact of short-term funding on staffing. METHODS: A national postal survey of smoking cessation coordinators in April 2002. Semi-structured interviews with 50 smoking cessation staff in two health regions in autumn 2001, followed by further interviews with 28 staff in the same areas in the autumn of 2002. RESULTS: Treatment was delivered in a wide range of venues, ranging from primary care to local authority-owned premises such as town halls and libraries. Most services offered both one-to-one and group support, although interviewees reported an increase in demand for one-to-one support from clients. Pharmacotherapies were used widely; by 2002, 99% of coordinators reported that their advisers recommended nicotine replacement therapy (NRT) to clients, and 95% bupropion. However, prior to April 2001 bupropion was available on prescription, but NRT was not and this variable access to pharmacotherapies posed problems for services. Coordinators reported that the short-term nature of funding made recruiting and retaining staff difficult and interviews revealed that they believed a longer period of protected funding was required for services to demonstrate their effectiveness. CONCLUSIONS: As English smoking treatment services developed, lessons were learned that could inform the development of services in other health systems. First, early guidance from government can encourage services to adhere to evidence-based treatment. Secondly, treatment needs to be accessible to smokers and thus there must be a flexible approach to implementation at local level. Thirdly, the availability of nicotine addiction and behavioural therapies should be coordinated to minimize barriers and maximize uptake. Finally, fixed-term funding can exacerbate staff recruitment and retention difficulties and countries establishing treatment services need to consider carefully the initial funding period that is required for stable services to become established within their health systems.

The English smoking treatment services: short-term outcomes.

AIMS: To examine the impact of socio-demographic factors, smoking-related behaviour and service characteristics on CO-validated quit rates at 4-week follow-up in English smoking treatment services, and to compare the results with those for self-reported quitters. DESIGN: Observational study of administrative information linked with survey data for 6959 recipients of smoking treatment services who set a quit date between October 2001 and March 2003. SETTING: Two contrasting areas of England, Nottingham and North Cumbria, consisting of nine primary care trust (PCT) localities. MEASUREMENTS: Routine monitoring data specified by the Department of Health included information about basic demographic characteristics, postcode of residence from which a deprivation category was identified, nature of intervention and smoking status at 4-week follow-up. These data were supplemented with additional information about referral pathways, socio-economic status and smoking-related behaviours obtained from consenting service recipients by NHS advisers. FINDINGS: More than one-half of clients (53%) were CO-validated as quitters at 4 weeks, rising to 60.7% when self-reported cases were included. Age (OR 1.026; CI 1.0221.029) and being extremely determined to quit (OR 1.46; CI 1.261.71) were associated positively with CO-validated cessation, whereas women (OR 0.85; CI 0.770.94), users with lower socio-economic status (OR 0.92; CI 0.880.95), those smoking 31 or more cigarettes daily (OR 0.75; CI 0.640.88) and those with relatively poor health status (OR 0.72; CI 0.630.82) were less likely to quit. Although the vast majority of users received one-to-one support, those who had group counselling were more likely to be successful in their quit attempt (OR 1.38; CI 1.091.76). Self-report and CO-validated quitters were similar in terms of their characteristics. CONCLUSIONS: These results obtained from routine services support those obtained from clinical trials and confirm the effectiveness of counselling combined with pharmacotherapies to assist smokers to quit in the short term. However, the relative effectiveness of group interventions raises questions about why one-to-one counselling is used much more commonly. The importance of socio-demographic and nicotine-related dependency factors also suggests that local service targets for smoking cessation need to take account of the social distribution of these characteristics.

Targeting smokers in priority groups: the influence of government targets and policy statements.

BACKGROUND: Cessation services were instructed to make special attempts to attract smokers from three 'priority groups': those who were young, pregnant and economically disadvantaged. Progress with attracting priority groups was not assessed formally, but services were set monitored targets to encourage throughput of smokers. Initial research suggests that services have been successful in attracting smokers who live in disadvantaged areas. This paper investigates how smoking cessation services responded to targets and instructions to attract priority groups and discusses the relative impact these on service development. OBJECTIVES: To describe how monitored throughput targets influenced the development of smoking cessation services, including attracting priority groups. To describe the range of priority groups that smoking cessation services targeted, methods used and reported progress with this. METHODS: Postal surveys of English smoking cessation coordinators conducted in April 2001 and April 2002. Seventy-eight qualitative, semistructured interviews with cessation service staff in two former English health regions conducted in autumn 2001 and 1 year later. FINDINGS: A total of 69.3% of coordinators responded to the first survey (79% to the second survey). In the first survey 91% reported targeting priority groups (100% in the second survey). The proportions (second survey in brackets) who reported targeting the different priority groups were: pregnant women 86% (99%), economically disadvantaged 79% (100%) and young smokers 20% (75%). Interviews showed that coordinators gave the greatest priority to reaching monitored targets as they came under pressure to achieve these. Service staff were generally unclear about how to attract priority groups and developing strategies for this was hindered by the need to meet throughput targets. Locating services in poor areas was thought to attract economically disadvantaged smokers and specialist staff were being appointed to work with pregnant smokers, but otherwise there was little evidence of active strategies for attracting priority groups being applied in practice. CONCLUSIONS: Monitored targets for smoker throughput ensured that services quickly began to treat smokers, but this rapid implementation diverted service staff from devising methods for attracting priority group smokers. Coordinators found reaching priority groups challenging and, particularly in the case of young smokers, would have appreciated clear instructions for this aspect of service implementation. Those implementing services in other countries should consider whether similar targets would be helpful to stimulate service development within their health systems.

How effective are the English smoking treatment services in reaching disadvantaged smokers?

AIMS: To determine the effectiveness of smoking cessation services in enabling smokers living in disadvantaged areas to access treatment services, and to assess the extent of variations between areas. DESIGN: Observational study of administrative information linked with survey data. SETTING: A representative sample of 19 of the 95 English health areas in 2001. MEASUREMENTS: All England smoking data by deprivation category obtained from the Health Survey of England were used to estimate neighbourhood smoking prevalence rates. Area of residence data from smokers setting a quit date were used to calculate the proportion of smokers in receipt of treatment services in different economic deprivation categories. FINDINGS: In general, treatment services were seeing smokers from the most disadvantaged areas where smoking prevalence rates were highest; 32.3% of all smokers in receipt of treatment services lived in the most disadvantaged quintile of areas compared with 9.6% resident in the most advantaged quintile. An indicator of 'positive discrimination' was calculated for each health authority area to quantify the extent to which the proportion of disadvantaged smokers being treated was greater than the proportion in the local population. This figure ranged from just under 0% to 18%. CONCLUSIONS: National Health Service (NHS) smoking cessation services have been successful in reaching smokers from disadvantaged communities. If improved access to support for smokers living in the poorest communities can be extended, sustained and translated into long-term quitting then smoking cessation services have the potential to make a useful contribution to addressing inequalities in health.

The English smoking treatment services: one-year outcomes.

AIMS: To assess the impact of English treatment services on CO-validated quit rates at 52-week follow-up, to explore the relationship between service-related characteristics and socio-demographic and behavioural factors with cessation outcomes, and to compare the characteristics of service users lost to follow-up with CO-validated quitters. DESIGN: Observational study of administrative information linked with survey data for 2069 recipients of smoking treatment services who set a quit date between May and November 2002. SETTING: Two contrasting areas of England, Nottingham and North Cumbria, consisting of nine primary care trust (PCT) localities. MEASUREMENTS: Routine monitoring data specified by the Department of Health included information about basic demographic characteristics, postcode of residence from which a deprivation category was identified, nature of intervention, and smoking status at 4-week follow-up. These data were supplemented with information about smoking status at 52 weeks, referral pathways, relapse experiences, number of follow-up contact attempts, socio-economic status and smoking-related behaviours obtained from consenting service recipients by treatment advisers. FINDINGS: One user in seven (14.6%) reported prolonged abstinence and was CO-validated as a successful quitter at 52 weeks. This rose to 17.7% when self-report cases were included. Relapse rates between 4 and 52 weeks were almost identical between the two study areas--75%. Relapse was most likely to occur in the first 6 months following treatment. Users who self-reported quitting at 4 weeks were less likely (13.7%) than those with biochemical verification of smoking status at 4 weeks (25.2%) to be CO-validated quitters at 52 weeks (P = 0.004). Older users (OR 1.023; CI 1.014-1.032), people who smoke mainly for pleasure rather than to cope (OR 1.38; CI 1.02-1.87), and those who were extremely determined (OR 1.58; CI 1.21-2.05) were more likely to be quitters at 52-week follow-up, whereas those with lower socio-economic status (OR 0.86; CI 0.78-0.96), who smoked their first cigarette of the day within 5 minutes of waking (OR 0.73; CI 0.55-0.96) or had another smoker in their household (OR 0.65; CI 0.49-0.86) were less likely. In contrast, users lost to follow-up tended to be younger and experienced different referral pathways than CO-validated quitters. Gender was not statistically significantly associated with cessation at 52 weeks and nor were any of the key characteristics of intervention, such as group or one-to-one counselling. CONCLUSIONS: These results obtained from routine services are consistent with those obtained from clinical trials in relation to abstinence at one year. Given that a high proportion of smokers relapsed between 4 weeks and 1 year it is important that future assessments of longer-term outcomes are conducted. However, following-up service users many months after an intervention is expensive, and reasonable estimates of quit rates can be estimated from short-term outcomes, provided that they have been CO-validated. Future studies should monitor outcomes from a selection of services treating different groups of smokers, particularly if more is to be learned about the role of smoking treatment services in reducing inequalities in health.