The association between habitual physical activity and cigarette cravings, and influence of smokers' characteristics in disadvantaged smokers not ready to quit.

RATIONALE: Habitual physical activity (PA) may have an important role in suppressing cigarette cravings. Systematic reviews show a strong acute effect of bouts of PA on reducing cigarette cravings, and it may be that these effects accumulate. OBJECTIVES: The aim was to investigate the relationship between habitual levels of PA and cigarette cravings in disadvantaged smokers not ready to quit by examining baseline cross-sectional data from the Exercise Assisted Reduction then Stop smoking study (EARS). METHODS: A series of linear regression models were applied to investigate the relationship between habitual PA and cigarette cravings and to identify additional predictors of cigarette cravings. The analyses were extended by including interaction terms with PA to identify potential moderators of the relationship between PA and cravings. RESULTS: A higher level of moderate intensity PA was associated with lower cravings (p = 0.033). Additional predictors were the mood and physical symptoms scale (p = 0.007; higher scores were associated with higher cravings) and alcohol consumption (p = 0.002; higher consumption was associated with lower cravings). In addition, a moderation effect of alcohol consumption was found; at higher levels of alcohol consumption, higher PA was significantly associated with higher cravings (p = 0.023). CONCLUSIONS: Overall, participation in regular PA is associated with reduced cigarette cravings; among those with heavy alcohol consumption, this participation is associated with higher cravings. These exploratory analyses suggest that further research into the relationship between PA, alcohol consumption and cigarette cravings is needed

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation.

This is the final version of the article. Available from the publisher via the DOI in this record.BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation followed by induction and maintenance immunosuppressive therapy to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To systematically review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect,(®) Novartis Pharmaceuticals) and rabbit antihuman thymocyte immunoglobulin (Thymoglobuline,(®) Sanofi) as induction therapy and immediate-release tacrolimus [Adoport(®) (Sandoz); Capexion(®) (Mylan); Modigraf(®) (Astellas Pharma); Perixis(®) (Accord Healthcare); Prograf(®) (Astellas Pharma); Tacni(®) (Teva); Vivadex(®) (Dexcel Pharma)], prolonged-release tacrolimus (Advagraf,(®) Astellas Pharma); belatacept (BEL) (Nulojix,(®) Bristol-Myers Squibb), mycophenolate mofetil (MMF) [Arzip(®) (Zentiva), CellCept(®) (Roche Products), Myfenax(®) (Teva), generic MMF is manufactured by Accord Healthcare, Actavis, Arrow Pharmaceuticals, Dr Reddy's Laboratories, Mylan, Sandoz and Wockhardt], mycophenolate sodium, sirolimus (Rapamune,(®) Pfizer) and everolimus (Certican,(®) Novartis Pharmaceuticals) as maintenance therapy in children and adolescents undergoing renal transplantation. DATA SOURCES: Clinical effectiveness searches were conducted to 7 January 2015 in MEDLINE (via Ovid), EMBASE (via Ovid), Cochrane Central Register of Controlled Trials (via Wiley Online Library) and Web of Science [via Institute for Scientific Information (ISI)], Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment (HTA) (The Cochrane Library via Wiley Online Library) and Health Management Information Consortium (via Ovid). Cost-effectiveness searches were conducted to 15 January 2015 using a costs or economic literature search filter in MEDLINE (via Ovid), EMBASE (via Ovid), NHS Economic Evaluation Databases (via Wiley Online Library), Web of Science (via ISI), Health Economic Evaluations Database (via Wiley Online Library) and EconLit (via EBSCOhost). REVIEW METHODS: Titles and abstracts were screened according to predefined inclusion criteria, as were full texts of identified studies. Included studies were extracted and quality appraised. Data were meta-analysed when appropriate. A new discrete time state transition economic model (semi-Markov) was developed; graft function, and incidences of acute rejection and new-onset diabetes mellitus were used to extrapolate graft survival. Recipients were assumed to be in one of three health states: functioning graft, graft loss or death. RESULTS: Three randomised controlled trials (RCTs) and four non-RCTs were included. The RCTs only evaluated BAS and tacrolimus (TAC). No statistically significant differences in key outcomes were found between BAS and placebo/no induction. Statistically significantly higher graft function (p < 0.01) and less biopsy-proven acute rejection (odds ratio 0.29, 95% confidence interval 0.15 to 0.57) was found between TAC and ciclosporin (CSA). Only one cost-effectiveness study was identified, which informed NICE guidance TA99. BAS [with TAC and azathioprine (AZA)] was predicted to be cost-effective at £20,000-30,000 per quality-adjusted life year (QALY) versus no induction (BAS was dominant). BAS (with CSA and MMF) was not predicted to be cost-effective at £20,000-30,000 per QALY versus no induction (BAS was dominated). TAC (with AZA) was predicted to be cost-effective at £20,000-30,000 per QALY versus CSA (TAC was dominant). A model based on adult evidence suggests that at a cost-effectiveness threshold of £20,000-30,000 per QALY, BAS and TAC are cost-effective in all considered combinations; MMF was also cost-effective with CSA but not TAC. LIMITATIONS: The RCT evidence is very limited; analyses comparing all interventions need to rely on adult evidence. CONCLUSIONS: TAC is likely to be cost-effective (vs. CSA, in combination with AZA) at £20,000-30,000 per QALY. Analysis based on one RCT found BAS to be dominant, but analysis based on another RCT found BAS to be dominated. BAS plus TAC and AZA was predicted to be cost-effective at £20,000-30,000 per QALY when all regimens were compared using extrapolated adult evidence. High-quality primary effectiveness research is needed. The UK Renal Registry could form the basis for a prospective primary study. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014013544. FUNDING: The National Institute for Health Research HTA programme.The research reported in this issue of the journal was commissioned and funded by the HTA programme on behalf of NICE as project number 09/119/01. The protocol was agreed in July 2014. The assessment report began editorial review in May 2015 and was accepted for publication in October 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health

The effectiveness and cost-effectiveness of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating cancer-treatment induced anaemia (including review of TA142): a systematic review and economic model

Background: Anaemia is a common side-effect of cancer treatments and can lead to a reduction in quality of life. Erythropoiesis-stimulating agents (ESAs) are licensed for use in conjunction with red blood cell transfusions (RBCTs) to improve cancer treatment-induced anaemia (CIA). Methods: The clinical effectiveness review followed principles published by NHS CRD. Randomised controlled trials (RCTs), or systematic reviews of RCTs, of ESAs (epoetin or darbepoetin) for treating people with CIA were eligible for inclusion in the review. Comparators were best supportive care (BSC), placebo, or other ESA. Anaemia- and malignancy-related outcomes, health-related quality of life (HRQoL), and adverse events (AEs) were evaluated. Where appropriate, data were pooled using meta-analysis. An empirical health economic model was developed comparing ESA treatment to no ESA treatment. The model has two components: one evaluating short-term costs and QALYs (while patients are anaemic); and one evaluating long-term QALYs. Costs and benefits were discounted at 3.5% pa. Probabilistic and univariate deterministic sensitivity analyses were performed. Results: Twenty-three studies assessing ESAs within their licensed indication (based on start dose administered) were included. None of the RCTs were completely aligned with current EU licenses. Results suggest that there is clinical benefit from ESAs for anaemia-related outcomes. Data suggest improvement in HRQoL scores. The impact of ESAs on AEs and survival remains highly uncertain; although point estimates are lower confidence intervals are wide and not statistically significant. Base case incremental cost-effectiveness ratios (ICERs) for ESA treatment versus no ESA treatment ranged from £19,429–£35,018 per quality-adjusted life year (QALY) gained, but sensitivity and scenario analyses demonstrate considerable uncertainty in these ICERs, including the possibility of overall health disbenefit. All ICERs were sensitive to survival and cost. Conclusions: ESAs could be cost-effective when used closer to licence but there is considerable uncertainty mainly due to unknown impacts on overall survival

Physical activity for antenatal and postnatal depression in women attempting to quit smoking: randomised controlled trial

Background: Antenatal depression is associated with harmful consequences for both the mother and child. One intervention that might be effective is participation in regular physical activity although data on this question in pregnant smokers is currently lacking. Methods: Women were randomised to six-weekly sessions of smoking cessation behavioural-support, or to the same support plus 14 sessions combining treadmill exercise and physical activity consultations. Results: Among 784 participants (mean gestation 16-weeks), EPDS was significantly higher in the physical activity group versus usual care at end-of-pregnancy (mean group difference (95% confidence intervals (CIs)): 0.95 (0.08 to 1.83). There was no significant difference at six-months postpartum. Conclusion: A pragmatic intervention to increase physical activity in pregnant smokers did not prevent depression at end-of-pregnancy or at six-months postpartum. More effective physical activity interventions are needed in this population. Trial registration: Current Controlled Trials ISRCTN48600346. The trial was prospectively registered on 21/07/2008

Exercise counseling to enhance smoking cessation outcomes: the Fit2Quit randomized controlled trial

BACKGROUND: Regular exercise has been proposed as a potential smoking cessation aid. PURPOSE: This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks. METHODS: A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone. RESULTS: There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01). CONCLUSIONS: Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.).This was an investigator-initiated study funded by a grant from the Health Research Council of New Zealand (09/338R) and a small project grant from the Heart Foundation of New Zealand (1405). RM was supported by a Heart Foundation of New Zealand Fellowship. VR was supported by a University of Auckland Doctoral Scholarshi

The acute effects of physical activity on cigarette cravings: exploration of potential moderators, mediators and physical activity attributes using individual participant data (IPD) meta-analyses

This is the author accepted manuscript. The final version is available from Springer Verlag via the DOI in this record.RATIONALE: The effects of acute bouts of physical activity (PA) on Strength of Desire (SoD) and Desire to Smoke (DtS) using individual participant data (IPD) from 19 acute randomised controlled studies were quantified. However, there is a need to identify factors influencing this relationship. OBJECTIVES: To understand who most benefits from PA, whether changes in affect mediate these effects and whether any specific attributes of PA are associated with cigarette cravings. METHODS: IPD (n = 930) contributed to one-stage IPD meta-analyses. Participants engaging in PA were compared against controls, using post-intervention DtS and SoD (when DtS is not available) with baseline adjustments. The craving scales were linearly rescaled to 0-100 % (a mean difference between groups of -10 would indicate that post-intervention cravings were 10 % lower in the PA compared with the control group). Demographic, smoking and other characteristics were examined as predictors and potential moderators, whereas change in affect was considered as a mediator. PA was categorised according to type, duration and intensity, to determine PA attributes associated with cravings reduction. RESULTS: None of the included covariates were shown to moderate or mediate the effects of PA. Intensity of PA was significantly associated with a reduction in cravings; moderate and vigorous intensity PA offered the most benefits. A one-stage IPD meta-analysis yielded effect sizes of -9.22 (-15.24; -3.20) for light, -34.57 (-42.64; -26.50) for moderate and -31.29 (-38.00; -24.57) for vigorous intensity in comparison with controls. CONCLUSIONS: Moderate intensity PA could be recommended to all smokers regardless of demographic, smoking and other characteristics.This research was conducted with the support of internal institutional funds. The authors have received no other direct or indirect support, and none of the researchers have any connection with the tobacco or pharmaceutical industries. Some authors (M.H.; M.U.; K.J.V.R; G.F.; M.C.; J.B.D.; E.E.H.; H.O.; A.H.T) are also authors of some of the included primary studies

The acute effects of physical activity on cigarette cravings: exploration of potential moderators, mediators and physical activity attributes using individual participant data (IPD) meta-analyses

This is the author accepted manuscript. The final version is available from Springer Verlag via the DOI in this record.RATIONALE: The effects of acute bouts of physical activity (PA) on Strength of Desire (SoD) and Desire to Smoke (DtS) using individual participant data (IPD) from 19 acute randomised controlled studies were quantified. However, there is a need to identify factors influencing this relationship. OBJECTIVES: To understand who most benefits from PA, whether changes in affect mediate these effects and whether any specific attributes of PA are associated with cigarette cravings. METHODS: IPD (n = 930) contributed to one-stage IPD meta-analyses. Participants engaging in PA were compared against controls, using post-intervention DtS and SoD (when DtS is not available) with baseline adjustments. The craving scales were linearly rescaled to 0-100 % (a mean difference between groups of -10 would indicate that post-intervention cravings were 10 % lower in the PA compared with the control group). Demographic, smoking and other characteristics were examined as predictors and potential moderators, whereas change in affect was considered as a mediator. PA was categorised according to type, duration and intensity, to determine PA attributes associated with cravings reduction. RESULTS: None of the included covariates were shown to moderate or mediate the effects of PA. Intensity of PA was significantly associated with a reduction in cravings; moderate and vigorous intensity PA offered the most benefits. A one-stage IPD meta-analysis yielded effect sizes of -9.22 (-15.24; -3.20) for light, -34.57 (-42.64; -26.50) for moderate and -31.29 (-38.00; -24.57) for vigorous intensity in comparison with controls. CONCLUSIONS: Moderate intensity PA could be recommended to all smokers regardless of demographic, smoking and other characteristics.This research was conducted with the support of internal institutional funds. The authors have received no other direct or indirect support, and none of the researchers have any connection with the tobacco or pharmaceutical industries. Some authors (M.H.; M.U.; K.J.V.R; G.F.; M.C.; J.B.D.; E.E.H.; H.O.; A.H.T) are also authors of some of the included primary studies