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Association of a Healthy Lifestyle With All-Cause and Cause-Specific Mortality Among Individuals With Probable Sarcopenia: Population-Based Cohort Study.
BACKGROUND: Individuals with probable sarcopenia have shown excess mortality, yet no specific treatment regimen has been established. While lifestyle factors improve health and longevity in general populations, their role in probable patients with sarcopenia remains unclear due to differing lifestyle patterns. Clarifying this could inform strategies to address this unmet need. OBJECTIVE: We aim to quantify the impact of a healthy lifestyle on all-cause and cause-specific mortality in probable sarcopenic populations using a large-scale prospective cohort study. METHODS: Participants were selected from the UK Biobank, aged 40-69 years, during 2006-2010. Probable sarcopenia was identified according to EWGSOP2 (European Working Group on Sarcopenia in Older People 2) criteria, resulting in 20,654 participants being included in this study. Death dates and underlying causes were obtained from the National Health Service Information Center. Cox proportional hazard models and population-attributable risk were used to assess the associations between healthy lifestyle factors and premature mortality risk. RESULTS: A total of 20,654 individuals with probable sarcopenia were included in this study. The median age of the population was 62.0 (IQR 56.0-66.0) years, and 60.6% (n=12,528) were women. During a median follow-up duration of 11.5 (IQR 10.8-12.3) years, 2447 participants died. All healthy lifestyle factors, including nonsmoking (P
Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.
OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after total hip replacement (THR) or total knee replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial. SETTING: National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged ≥18 years, undergoing a primary THR or TKR deemed 'moderately inactive' or 'inactive'. INTERVENTION: Participants received either six, 30 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION AND BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 and 12-month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental: 85 usual care). Mean age was 68.4 years (SD: 8.7), 63% were women, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at 6 or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution. TRIAL REGISTRATION NUMBER: ISRCTN29770908.
Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial.
OBJECTIVE: To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. DESIGN: Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. SETTING: Secondary care trauma units across 19 hospitals in the United Kingdom's health service. PARTICIPANTS: Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. INTERVENTIONS: Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). MAIN OUTCOMES AND MEASURES: Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. RESULTS: Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. CONCLUSIONS: There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit. TRIAL REGISTRATION: ISRCTN54992179.
O-substituted alkyl aldehydes for rhodium-catalyzed intermolecular alkyne hydroacylation: the utility of methylthiomethyl ethers.
Combining α-methylthiomethyl (MTM) ether substituted aldehydes and 1-alkynes in the presence of [Rh(dppe)]ClO(4) results in efficient intermolecular alkyne hydroacylation to deliver α-O-MTM-substituted enone products. The product MTM ethers can be converted to the free hydroxyl group either in situ, by the addition of water to the completed reaction, or in a separate operation, by the action of silver nitrate.
Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial.
BACKGROUND: There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) trial. METHODS: PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function. Patients are identified in the orthopaedic/trauma outpatient clinic. The primary outcome is muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules), at 24 weeks post randomisation. Multivariate linear regression adjusting for the stratification factors (centre and age) and additional prognostic factors will be used to investigate the adjusted effect of the intervention. The analysis will be by modified intention-to-treat. Sensitivity analysis will assess the internal validity of the trial results by performing a per-protocol analysis. Safety will be summarised by treatment arm for all patients who started treatment. Secondary patient-reported outcome measures will be analysed using linear mixed effects models to allow all data collected at all follow-up points to be considered. Missing data will be summarised and reported by treatment arm. Missing data imputation will be performed, if appropriate. DISCUSSION: The PATH-2 trial will be reported in accordance with the CONSORT statement. This SAP publication will avoid bias arising from prior knowledge of the study results. Any changes or deviations from the current SAP will be described and justified in the final report. TRIAL REGISTRATION: ISRCTN registry: ISRCTN54992179 , assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.
SWAT 110: Printing the primary outcomE on Pink PapER versus standard paper to increase participant engagement to postal questionnaires (PEPPER)
Background: Missing data is a common issue in randomised controlled trials. There is a need to rigorously test means of participant retention. This embedded trial aims to examine the effect on postal response rates of printing a randomised controlled trial’s primary outcome on pink versus white paper. Methods: Our randomised Study Within A Trial (SWAT) was run within a behaviour-change intervention host trial for patients following hip or knee replacements. Participants were randomised to receive the host trial’s primary outcome measure printed on either a sheet of pink or white paper within the 11 sheet (21 page) six-month follow-up questionnaire. The SWAT’s primary outcome was host trial primary outcome measure completion. Number of reminders sent, proportion of remaining questions completed and overall questionnaire returns were secondary outcomes. Results: 176 participants were randomised: 88 received pink paper, 88 white paper. Host trial primary outcome measures were returned by 84.1% (74/88 participants) in the pink paper group and in 90.9% (80/88 participants) in the white paper group (risk ratio, 0.92 [95% CI 0.80, 1.06]; p=0.24). Reminders were sent to 48.9% (43/88 participants) in the pink paper group and in 30.7% (27/88 participants) in the white paper group (risk ratio 1.59 [95% CI 1.09, 2.33]; p=0.01). No other results were statistically significant. Conclusion: Printing the primary outcome on pink paper does not increase data return. From this small randomised study, there is some evidence that it potentially decreases response and is more burdensome to collect postal data by increasing the necessity for reminders.
Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.
Platelet-rich plasma (PRP) is an autologous preparation that has been claimed to improve healing and mechanobiological properties of tendons both in vitro and in vivo. In this sub-study from the PATH-2 (PRP in Achilles Tendon Healing-2) trial, we report the cellular and growth factor content and quality of the Leukocyte-rich PRP (L-PRP) (N = 103) prepared using a standardized commercial preparation method across 19 different UK centers. Baseline whole blood cell counts (red cells, leukocyte and platelets) demonstrated that the two groups were well-matched. L-PRP analysis gave a mean platelet count of 852.6 x 109/L (SD 438.96), a mean leukocyte cell count of 15.13 x 109/L (SD 10.28) and a mean red blood cell count of 0.91 x 1012/L (SD 1.49). The activation status of the L-PRP gave either low or high expression levels of the degranulation marker CD62p before and after ex-vivo platelet activation respectively. TGF-β, VEGF, PDGF, IGF and FGFb mean concentrations were 131.92 ng/ml, 0.98 ng/ml, 55.34 ng/ml, 78.2 ng/ml and 111.0 pg/ml respectively with expected correlations with both platelet and leukocyte counts. While PATH-2 results demonstrated that there was no evidence L-PRP is effective for improving clinical outcomes at 24 weeks after Achilles tendon rupture, our findings support that the majority of L-PRP properties were within the method specification and performance.
Platelet-rich plasma injection for adults with acute Achilles tendon rupture: the PATH-2 RCT
Background Achilles tendon rupture (ATR) has a long healing period, which is challenging for patients and clinicians. Platelet-rich plasma (PRP) is an autologous concentration of platelets thought to improve tendon function recovery. Although preliminary research has indicated positive effects, there is, as yet, no evidence of clinical efficacy from adequately powered robust clinical trials. Objectives The objectives were to determine the clinical efficacy of PRP in patients with acute ATR using an objective mechanical muscle–tendon function measure and patient-reported outcome measures (PROMs), and to determine which PRP components contribute to its mechanism. Design This was a multicentre, parallel-group, participant- and outcome assessor-blinded randomised controlled trial (RCT) comparing PRP with placebo. Two embedded substudies investigated the PRP’s quality and composition and its effects on healing tendon tissues. Setting This trial was set in trauma and orthopaedic surgery departments in 19 NHS hospitals in England and Wales. Participants Adults with acute ATR presenting within 12 days of injury to be treated non-surgically were eligible. Patients with platelet dysfunction or leg functional deficiency were excluded. Interventions Participants were randomised 1 : 1 to the PRP injection group or the placebo group (dry needle in the rupture gap) by central computer-based randomisation using minimisation, stratified by centre and age. Main outcome measures The primary outcome measure was the Limb Symmetry Index (LSI) of work during the heel-rise endurance test at 24 weeks. Secondary outcomes measures, collected at 4, 7, 13 and 24 weeks, were repetitions, maximum heel-rise height, Achilles tendon Total Rupture Score (ATRS), quality of life (as measured using the Short Form questionnaire-12 items version 2), pain and participant goal attainment. Needle biopsies of the affected tendon zone were taken under ultrasound guidance at 6 weeks from 16 participants from one centre. Whole blood was analysed for cell count. PRP was analysed for cell count, platelet activation and growth factor concentration. The primary analysis was intention to treat. Results A total of 230 participants were randomised: 114 to the PRP group (103 treated) and 116 to the placebo group (all treated). One participant withdrew after randomisation but before the intervention. At 24 weeks, 201 out of 230 participants (87.4%) completed the primary outcome and 216 out of 230 participants (93.9%) completed the PROMs. The treatment groups had similar participant characteristics. At 24 weeks, there was no difference in work LSI (mean difference –3.872; 95% confidence interval –10.454 to 2.710; p = 0.231), ATRS, pain or goal attainment between PRP- and placebo-injected participants. There were no differences between the groups in any PROM at any time point or in complication rates, including re-rupture and deep-vein thrombosis. There was no correlation between work LSI and platelet activation in PRP, or erythrocyte, leucocyte or platelet counts in whole blood or PRP. Biopsies showed similar cellularity and vascularity between groups. Conclusions This trial design and standardised PRP preparation gives the first robust RCT evidence about PRP’s role in managing ATR, which suggests that PRP offers no patient benefit. Equally robust evidence to investigate PRP application in tendon and soft tissue injuries is required. The 24-month follow-up will be completed in April 2020.
A systematic review of evidence regarding the association between time to mobilization following hip fracture surgery and patient outcomes.
AIMS: Performance indicators are increasingly used to evaluate the quality of healthcare provided to patients following a hip fracture. In this systematic review, we investigated the association between 'early mobilization' after surgery and patient outcomes. METHODS: Evidence was searched through 12 electronic databases and other sources. The methodological quality of studies meeting the inclusion criteria was assessed. The protocol for this suite of related systematic reviews was registered at PROSPERO: ID = CRD42023417515. RESULTS: A total of 24,507 articles were reviewed, and 20 studies met the inclusion criteria for the review, involving a total of 317,173 patients aged over 60 years with a hip fracture. There were two randomized clinical trials, five prospective studies, and 13 retrospective cohort studies, conducted between January 1981 and June 2022. All but two studies came from high-income healthcare systems. The definition of early mobilization varied across studies and health systems; and weightbearing status was often not reported or ambiguously defined, making formal meta-analysis of the data impossible. Early mobilization (within 48 hours of surgery) was associated with improved outcomes in 29 of the 33 patient-reported outcomes, including improved mobility scores and improved assessments of daily activities of living. A total of 45 out of 51 clinical outcomes derived from hospital records showed a positive association with early mobilization, including reduced rates of postoperative complications, reduced length of acute hospital stay, and lower mortality. CONCLUSION: Early mobilization after surgery for hip fracture in older people is associated with improved patient-reported outcomes and reduced length of hospital stay. Standardization of the definition of early mobilization and consistent reporting of weightbearing status would improve future evidence synthesis.
Longitudinal modelling of growth in neonates exposed to antenatal steroids to quantify associations with final height: a cohort study.
OBJECTIVE: To assess the associations of antenatal steroids with child growth. DESIGN: Longitudinal observational cohort study started in 1994. SETTING: A single tertiary neonatal centre in Sheffield, UK. PARTICIPANTS: Of 254 individuals recruited, two were excluded, 48 born at term; 202 (57% boys, 87% white ethnicity) modelled had a median of 19 height measurements each (Q1:12 to Q3:21) up to median age 15.8 years (Q1:9.9 to Q3:16.9). INTERVENTIONS: Data on administration of antenatal steroids were collected alongside gestational age and parental height. MAIN OUTCOME MEASURES: Height was modelled with SuperImposition by Translation and Rotation (SITAR) to extract each person's peak velocity and age at peak velocity via the SITAR random effects of 'size', 'timing' and 'intensity' and to predict height at 18 years. The association of each random effect and final height with exposure to antenatal steroids was assessed by multiple regression to adjust for covariates. RESULTS: In girls with covariates available (n=59/87), exposure to antenatal steroids was positively associated with SITAR 'size' and 'intensity' of growth when adjusted for gestational age, maternal and paternal height, equating to a final height 2.8 cm (95% CI 0.3 to 5.3 cm) greater than for those not exposed to antenatal steroids. In boys (n=66/115), exposure to antenatal steroids had no association with final height. CONCLUSIONS: This observational cohort study showed greater height of girls exposed to antenatal steroids not seen in boys. Analysis of existing long-term follow-up data from neonates is indicated to increase understanding of the associations of neonatal interventions on growth.
A 3-week pause versus continued Bruton tyrosine kinase inhibitor use during COVID-19 vaccination in individuals with chronic lymphocytic leukaemia (IMPROVE trial): a randomised, open-label, superiority trial.
BACKGROUND: Chronic lymphocytic leukaemia is the commonest leukaemia and is associated with profound immunosuppression. Bruton tyrosine kinase inhibitors (BTKi) have revolutionised chronic lymphocytic leukaemia management; however, therapy impairs vaccine-induced immunity. We evaluated whether a 3-week pause of BTKi treatment improved spike protein receptor binding domain (RBD) immunity to SARS-CoV-2 booster vaccination while maintaining disease control. METHODS: We performed an open-label, two-arm, parallel-group, randomised trial in secondary-care haematology clinics in 11 UK hospitals. Participants aged 18 years or older, diagnosed with chronic lymphocytic leukaemia, and currently taking BTKi therapy (frontline or relapsed setting) for at least 12 months were eligible. Participants were randomly allocated (1:1, by a centralised computer randomisation program, stratified by BTKi therapy line) to pause BTKi for 3 weeks, starting 6 days before their SARS-CoV-2 vaccination booster date, or to continue therapy as usual. Neither participants nor clinical staff were blinded but laboratory staff were. Intramuscular injection of either original BA.1 or original BA.4/5 bivalent mRNA vaccine (50 μg mRNA-1273 or 30 μg BNT162b2), or 5 μg protein-based Vidprevtyn Beta (Sanofi Pasteur, Lyon, France) were received according to the national vaccination programme schedule. The primary outcome measure was anti-spike-RBD-specific antibody titre 3 weeks after vaccination and analysis performed by intention to treat (as randomly allocated, irrespective of compliance) following trial completion. This trial is registered with ISRCTN, 14197181, and has been completed. FINDINGS: Between Oct 10, 2022, and June 8, 2023, 99 individuals (71 [72%] male and 28 [28%] female, with 89 [90%] of White ethnicity) were randomly allocated to groups pausing (n=50 [51%]) or continuing (n=49 [49%]) their BTKi therapy, and followed up for 12 weeks. At 3 weeks after vaccination, the geometric mean anti-spike-RBD-specific antibody titre was 218·8 U/mL (SD 122·9) in the continue group and 153·4 U/mL (103·2) in the pause group, with geometric mean ratio 1·104 (95% CI 0·565-2·158, p=0·77) using a mixed-effects model. The only serious adverse event during the 12-week follow-up was the death of one participant in the pause group due to COVID-19 infection 2 months after randomisation. INTERPRETATION: Although the study was slightly underpowered, the results suggest that pausing BTKi around the time of vaccination is not beneficial for immunity and should not be recommended in clinical practice. FUNDING: National Institute for Health and Care Research.
Impact of Climate Change and Extreme Temperature on the Incidence of Infectious Disease Among Children and Adolescents in China: A Nationwide Case-crossover Study with over 8.7 million cases between 2008 and 2019.
BACKGROUND: The relationship between ambient temperature and infectious disease incidence lacks comprehensive documentation. Our study, therefore, sought to systematically determine the national association between temperature and the incidence of infectious diseases, categorized into respiratory, gastrointestinal and enterovirus, and vector-borne categories. We aimed to study the association between extreme cold and heat extreme temperature on infectious disease occurrence among children and teenagers, and to evaluate the secular trends in these diseases in relation to temperature extremes. METHODS: We accessed the dataset encompassing 8,731,930 cases of 27 distinct infectious diseases, spanning respiratory, gastrointestinal and enterovirus infections, and vector-borne categories, across 507 Chinese cities from 2008 to 2019. Employing a time-stratified case-crossover design, we quantified the association between temperature exposure and the risk of infectious diseases specific to each city. The attributable fractions for temperature-related risks were determined by identifying extreme temperatures exceeding the 90th percentile and falling below the 10th percentile of the respective city-specific temperature distributions, indicative of heat and cold effects. A comparative analysis of these attributable fractions between the periods 2008-2010 and 2017-2019 was conducted to evaluate the secular changes of infectious diseases associated with cold and heat. FINDINGS: Our analysis revealed significant non-linear associations between temperature and the incidence of specific infectious diseases. Cold temperatures were found to be responsible for 1.35% (95% CI: 1.18 to 1.51%) of respiratory infectious disease cases. In contrast, heat was attributed to a lower proportion, with 0.29% (95% CI: 0.25 to 0.33%) of such cases. Among gastrointestinal and enterovirus diseases, a more substantial 4.93% (95% CI: 4.82 to 5.04%) of cases were linked to heat exposure. Notably, vector-borne diseases demonstrated the highest attributable fraction to heat, with 22.12% (95% CI: 21.82 to 22.41%) of cases affected. Specifically, five diseases-scarlet fever, tuberculosis, mumps, leprosy, and typhus-exhibited an increased incidence associated with cold temperatures. Notably, for scarlet fever, leprosy, and typhus, the attributable fraction escalated from the period 2008-2010 to 2017-2019. However, findings for leprosy should be interpreted with caution due to its low incidence. As for heat-related diseases, thirteen were identified, with the attributable fraction for nine diseases-tuberculosis, pertussis, hand, foot, and mouth disease, infectious diarrhea, dysentery, hepatitis A, typhoid and paratyphoid, dengue, and Japanese encephalitis-showing a marked increase over the same comparative timeframes. INTERPRETATION: The temperature increase observed from 2008-2010 to 2017-2019 has been accompanied by a rising trend in heat-related infections. Among all infectious diseases in Chinese children and adolescents, more than half (13 out of 24) are heat-related, compared to five infections linked to extreme cold. The risk of gastrointestinal and enterovirus infections was associated with extreme hot temperatures, with vector-borne diseases particularly responsive to extreme heat. These findings highlight an urgent requirement for proactive public health measures to address the potential impact of temperature variability on infectious disease outbreaks, safeguarding vulnerable demographics in the context of climate change.
Association between the serotonin transporter gene and alcohol consumption in social drinkers
Relatively few studies have investigated the role of the 5HTT gene in intermediate phenotypes such as alcohol consumption in non-alcohol dependent populations. A recent study reported an association with alcohol consumption in a student population. We attempted to replicate these findings and extend on this work in a representative, ethnically homogenous, non-alcohol dependent sample of social drinkers in the United Kingdom. The short allele of the 5HTT gene was significantly associated with, increased alcohol consumption (P = 0.03). There was suggestive evidence of a genotype-sex interaction (P = 0.04). Post-hoc tests indicated higher alcohol consumption in men with one or more copies of the short allele, while in women consumption was highest among heterozygotes compared to both homozygote groups. Age at time of data collection and cigarette consumption were entered as covariates. These results replicate recent previous findings and suggest a possibility that this association may differ in men and women. © 2005 Wiley-Liss, Inc.
Zyban for smoking cessation in a general practice setting: the response to an invitation to make a quit attempt.
The objective of this study was to assess the feasibility and success of Zyban as part of a moderately supported smoking cessation programme within UK general practice. Treatment was offered to 479 moderately dependent smokers (smoking 15 or more cigarettes per day) who had never used Zyban, and who had taken part in a previous NRT trial (the PATCH study). Main outcome measures were point prevalence and continuous abstinence from smoking at 6 and at 12 months. Two hundred and forty were excluded because of medical reasons or prescribing contraindication. Of the remainder (n=239) only 54 (23%) made an active quit attempt. Thirty percent (16/54) were abstinent at six months, and 22% (12/54) at 12 months (biochemically validated point prevalence rates). Age, socio-economic status, nicotine dependence, and genetic profile appeared to have little impact on success rates, but male quit-attempters were significantly more successful than female (40% vs. 10% at 12 months, p<0.05). In conclusion, a real-world smoking cessation programme using Zyban with moderate support within a general practice setting may achieve satisfactory quit rates without widening existing disparities in cessation.