Identifying effective behavioural components of Intervention and Comparison group support provided in SMOKing cEssation (IC-SMOKE) interventions: a systematic review protocol Pharmacologic-based strategies for smoking cessation: clinical and cost-effectiveness analyses. Behavioural interventions for type 2 diabetes: an evidence-based analysis. All in the Family: systematic reviews, rapid reviews, scoping reviews, realist reviews, and more Cost-Effectiveness and Cost-Utility of Internet-Based Computer Tailoring for Smoking Cessation Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review Projected cost-effectiveness of smoking cessation interventions in patients hospitalized with myocardial infarction. Protocol for a systematic review and economic evaluation of the clinical and cost-effectiveness of non-hospital-based non-invasive ventilation (NIV) in patients with stable end-stage COPD with hypercapnic respiratory failure Community pharmacy interventions for public health priorities: protocol for a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions From the Editors’ Desk: Bias in Systematic Reviews—Let the Reader Beware
Background Systematic review s of behaviour change interventions for  smoking cessation  vary in scope , quality , and applicability . The current review aims to generate more accurate and useful findings by ( 1 ) a detailed analysis of intervention elements that change behaviour ( i.e. behaviour change techniques ( BCTs ) ) and potential moderators of behaviour change ( i.e. other intervention and sample characteristics ) and ( 2 ) assessing and controlling for variability in support provided to comparison groups in smoking cessation trials . Methods A systematic review will be conducted of r and omized controlled trials of behaviour change interventions for smoking cessation in adults ( with or without pharmacological support ) , with a minimum follow-up of 6 months , published after 1995 . Eligible articles will be identified through the Cochrane Tobacco Addiction Group Specialized Register . Study authors will be asked for detailed descriptions of smoking cessation support provided to intervention and comparison groups . All data will be independently coded by two research ers . The BCT taxonomy v1 ( tailored to smoking cessation interventions ) and template for intervention description and replication criteria will be used to code intervention characteristics . Data collection will further include sample and trial characteristics and outcome data ( smoking cessation rates ) . Multilevel mixed-effects meta-regression models will be used to examine which BCTs and /or BCT clusters delivered to intervention and comparison groups explain smoking cessation rates in treatment arms ( and effect sizes ) and what key moderators of behaviour change are . Predicted effect sizes of each intervention will be computed assuming all interventions are compared against comparison groups receiving the same levels of behavioural support ( i.e. low , medium , and high levels ) . Multi-disciplinary advisory board members ( policymakers , health care providers , and (ex-)smokers ) will provide strategic input throughout the project to ensure the review ’s applicability to policy and practice . Discussion By capturing BCTs in intervention and comparison groups , this systematic review will provide more accurate estimates of the effectiveness of smoking cessation interventions , the most promising BCTs and /or BCT clusters associated with smoking cessation rates in intervention and comparison arms , and important moderators of behaviour change . The results could set new st and ards for conducting meta-analyses of behaviour change interventions and improve research , service delivery , and training in the area of smoking cessation . Systematic review registration PROSPERO Tobacco smoking is a risk factor for cancer , respiratory disease , and cardiovascular disease . It is estimated that 19 % of Canadians ( approximately 5.2 million ) aged 15 years and older were smokers in 2007.1 Each year , approximately 45,000 Canadians die from smoking.2 Significantly , one-third of Canadian smokers aged 15 years or older express an intention to quit in the next 30 days.3 Nicotine , the addictive chemical component of tobacco products that attracts smokers , has consequences for personal and community health . Smoking is an addiction . Although many smokers report that they quit unaided , most smokers who try to quit without smoking cessation aids are unsuccessful in the long term . In the US and UK , 70 % of smokers intend to quit every year , 45 % try to quit , and less than 5 % are successful.4,5 The rate of relapse is high among smokers who quit without treatment . The proportion of smokers who can achieve abstinence for at least one week is 25 % to 51 % , 10 % to 20 % for those able to do it for at least three months , and only 3 % to 5 % for those able to abstain for six months.6 There are many prescribed pharmacotherapies for smoking cessation , including nicotine replacement products , bupropion , and varenicline . Smoking cessation programs often combine drug treatment and behavioural support ( such as psychological interventions , telephone support , and self-help ) . Objective The objective of the report was to : Compare the pharmacological agents ( drug-based smoking cessation aids ) to determine which of these works best ( clinical effectiveness ) at six months and 12 months after patients attempt to quit smoking . Perform an economic analysis to determine which smoking cessation therapy was the most cost-effective for patients , drug plans , and the Canadian health care system . Methods To compare pharmacological agents with or without behavioural support programs for  smoking cessation  in adults , a systematic review with meta-analyses and an economic evaluation were carried out . A budget impact analysis and an examination of current public funding and planning issues were also performed . For the clinical review , a total of 155 articles ( from August 1982 to June 2009 ) describing 143 trials were selected for inclusion in the clinical analyses . To meet the inclusion criteria , r and omized controlled trials ( RCTs ) must have reported biochemically vali date d measures of smoking abstinence from the study start date or from the target quit date of at least six months . Analyses were conducted using a Bayesian r and om effects model for mixed treatment comparisons meta- analysis . Continuous abstinence rates ( patients have not smoked at all since quitting ) and point prevalence abstinence rates ( patients have not smoked in the past seven days ) were analyzed separately . For the economic analysis , a decision-analytic model was constructed to assess the cost-effectiveness ( cost per additional quitter and cost per life-year gained ; cost per quality -adjusted life-year [ QALY ] gained ) of nicotine replacement therapy ( NRT ) , bupropion , and varenicline compared with no pharmacologic treatment , from the perspective of a publicly funded health care system . For the base case , the general population ( stratified by age and gender ) motivated to quit smoking was considered . Treatment strategies included one-time cessation interventions of NRT , bupropion , varenicline , and no pharmacologic treatment ; it was assumed that all patients received the same level of behavioural support . Budget impact analyses were conducted by comparing current utilization patterns of NRT , bupropion , and varenicline  , with alternative scenarios reflecting the prescription patterns of these therapies UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT Three years ago , we founded this journal focusing on publishing systematic review s , systematic review protocol s , and associated method ological development papers . Systematic review s , which developed in the social sciences in the 1970s , began to gain rapid momentum during the 1990s in response to concerns by policymakers and clinicians about the scientific validity of the prevailing paradigm of traditional narrative review s written by authoritative experts . What distinguished systematic review s was the use of formal explicit methods , in other words pre-specification , of what exactly was the question to be answered , how evidence was search ed for and assessed , and how it was synthesized in order to reach the conclusion . Importantly , these formal methods were described as part of the review itself in a Methods section . In turn , these methods themselves became the subject of hypothesis-testing studies , as investigators sought how best to search for evidence , assess studies for quality or risk of bias , determine under what conditions meta- analysis was justified , and how to best determine and characterize our confidence in the conclusions . The results of these hypothesis-testing studies led over time to improvements in the methods we use for systematic review s. Thus , systematic review s and this journal are part of an ever-evolving process whose foundations are rooted in the scientific method . Today , new forms of review s are appearing . These have emerged in response to policymakers and other stakeholders ’ needs for information , sometimes emergently or urgently , for which the existing systematic review model does not quite fit . Hence , the rapid review , when time is of the essence ; the scoping review , when what is needed is not detailed answers to specific questions but rather an overview of a broad field ; the evidence map , a cousin of scoping review s that commonly has a specific visual presentation of the evidence across a broad field ; and the realist review , where the question of interest includes how and why complex social interventions work in certain situations , rather than assume they either do or do not work at all . As Editors , we regularly get contacted by prospect i ve authors asking whether realist review s , or scoping review s , etc . , are “ within the scope ” for Systematic Review s , and therefore we judge it an opportune time to state our position on this matter . It is our view that all of these new forms of review s are related to systematic review s , similar to the way that different biological Species within the same Family are related to each other . We consider “ systematic review s ” to be the Family and the different forms of review s to be the different species . Just as in the biological classification , where the related organisms must share certain characteristics , so too must the different types of review s share a common characteristic . In this case , what is shared is their foundation in the scientific method , with their methods articulated in advance in sufficient detail that the review can be reproduced by others . A further defining feature is that there are scholars devoted to improving the methods over time via hypothesis-testing studies . Systematic Review s has responded to these emerging techniques and already publishes papers reporting methods and findings from the systematic review family and has for example published an extremely popular series on rapid review s. We would like to consoli date this position and invite su bmi ssion of these new species of review s , as long as they meet the qualifications just listed . We expect this process of evolution to continue and to refine the methods such that in 10 years ’ time , there will appear new , as yet unimagined species of review s— and perhaps some current species of review will become extinct . Thus , it is with the scientific method , which we believe is the foundation that unites the Family of systematic review Background Although effective smoking cessation interventions exist , information is limited about their cost-effectiveness and cost-utility . Objective To assess the cost-effectiveness and cost-utility of an Internet-based multiple computer-tailored smoking cessation program and tailored counseling by practice nurses working in Dutch general practice s compared with an Internet-based multiple computer-tailored program only and care as usual . Methods The economic evaluation was embedded in a r and omized controlled trial , for which 91 practice nurses recruited 414 eligible smokers . Smokers were r and omized to receive multiple tailoring and counseling ( n=163 ) , multiple tailoring only ( n=132 ) , or usual care ( n=119 ) . Self-reported cost and quality of life were assessed during a 12-month follow-up period . Prolonged abstinence and 24-hour and 7-day point prevalence abstinence were assessed at 12-month follow-up . The trial-based economic evaluation was conducted from a societal perspective . Uncertainty was accounted for by bootstrapping ( 1000 times ) and sensitivity analyses . Results No significant differences were found between the intervention arms with regard to baseline characteristics or effects on abstinence , quality of life , and addiction level . However , participants in the multiple tailoring and counseling group reported significantly more annual health care – related costs than participants in the usual care group . Cost-effectiveness analysis , using prolonged abstinence as the outcome measure , showed that the mere multiple computer-tailored program had the highest probability of being cost-effective . Compared with usual care , in this group € 5100 had to be paid for each additional abstinent participant . With regard to cost-utility analyses , using quality of life as the outcome measure , usual care was probably most efficient . Conclusions To our knowledge , this was the first study to determine the cost-effectiveness and cost-utility of an Internet-based smoking cessation program with and without counseling by a practice nurse . Although the Internet-based multiple computer-tailored program seemed to be the most cost-effective treatment , the cost-utility was probably highest for care as usual . However , to ease the interpretation of cost-effectiveness results , future research should aim at identifying an acceptable cutoff point for the willingness to pay per abstinent participant BACKGROUND Systematic review s may be compromised by selective inclusion and reporting of outcomes and analyses . Selective inclusion occurs when there are multiple effect estimates in a trial report that could be included in a particular meta- analysis ( e.g. from multiple measurement scales and time points ) and the choice of effect estimate to include in the meta- analysis is based on the results ( e.g. statistical significance , magnitude or direction of effect ) . Selective reporting occurs when the reporting of a subset of outcomes and analyses in the systematic review is based on the results ( e.g. a protocol -defined outcome is omitted from the published systematic review ) . OBJECTIVES To summarise the characteristics and synthesis e the results of empirical studies that have investigated the prevalence of selective inclusion or reporting in systematic review s of r and omised controlled trials ( RCTs ) , investigated the factors ( e.g. statistical significance or direction of effect ) associated with the prevalence and quantified the bias . SEARCH METHODS We search ed the Cochrane Methodology Register ( to July 2012 ) , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO and ISI Web of Science ( each up to May 2013 ) , and the US Agency for Healthcare Research and Quality ( AHRQ ) Effective Healthcare Program 's Scientific Re source Center ( SRC ) Methods Library ( to June 2013 ) . We also search ed the abstract books of the 2011 and 2012 Cochrane Colloquia and the article alerts for method ological work in research synthesis published from 2009 to 2011 and compiled in Research Synthesis Methods . SELECTION CRITERIA We included both published and unpublished empirical studies that investigated the prevalence and factors associated with selective inclusion or reporting , or both , in systematic review s of RCTs of healthcare interventions . We included empirical studies assessing any type of selective inclusion or reporting , such as investigations of how frequently RCT outcome data is selectively included in systematic review s based on the results , outcomes and analyses are discrepant between protocol and published review or non-significant outcomes are partially reported in the full text or summary within systematic review s. DATA COLLECTION AND ANALYSIS Two review authors independently selected empirical studies for inclusion , extracted the data and performed a risk of bias assessment . A third review author resolved any disagreements about inclusion or exclusion of empirical studies , data extraction and risk of bias . We contacted authors of included studies for additional unpublished data . Primary outcomes included overall prevalence of selective inclusion or reporting , association between selective inclusion or reporting and the statistical significance of the effect estimate , and association between selective inclusion or reporting and the direction of the effect estimate . We combined prevalence estimates and risk ratios ( RRs ) using a r and om-effects meta- analysis model . MAIN RESULTS Seven studies met the inclusion criteria . No studies had investigated selective inclusion of results in systematic review s , or discrepancies in outcomes and analyses between systematic review registry entries and published systematic review s. Based on a meta- analysis of four studies ( including 485 Cochrane Review s ) , 38 % ( 95 % confidence interval ( CI ) 23 % to 54 % ) of systematic review s added , omitted , up grade d or down grade d at least one outcome between the protocol and published systematic review . The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain . The meta-analytic estimate suggested an increased risk of adding or upgrading ( i.e. changing a secondary outcome to primary ) when the outcome was statistically significant , although the 95 % CI included no association and a decreased risk as plausible estimates ( RR 1.43 , 95 % CI 0.71 to 2.85 ; two studies , n = 552 meta-analyses ) . Also , the meta-analytic estimate suggested an increased risk of downgrading ( i.e. changing a primary outcome to secondary ) when the outcome was statistically significant , although the 95 % CI included no association and a decreased risk as plausible estimates ( RR 1.26 , 95 % CI 0.60 to 2.62 ; two studies , n = 484 meta-analyses ) . None of the included studies had investigated whether the association between statistical significance and adding , upgrading or downgrading of outcomes was modified by the type of comparison , direction of effect or type of outcome ; or whether there is an association between direction of the effect estimate and discrepant outcome reporting . Several secondary outcomes were reported in the included studies . Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic review s ( 6 % in one study and 22 % in the other ) . One study ( including 62 Cochrane Review s ) found that 32 % ( 95 % CI 21 % to 45 % ) of systematic review s did not report all primary outcomes in the abstract . Another study ( including 64 Cochrane and 118 non-Cochrane review s ) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes ( RR 2.66 , 95 % CI 1.81 to 3.90 ) . None of the studies included systematic review s published after 2009 when reporting st and ards for systematic review s ( Preferred Reporting Items for Systematic review s and Meta-Analyses ( PRISMA ) Statement , and Method ological Expectations of Cochrane Intervention Review s ( MECIR ) ) were disseminated , so the results might not be generalisable to more recent systematic review s. AUTHORS ' CONCLUSIONS Discrepant outcome reporting between the protocol and published systematic review is fairly common , although the association between statistical significance and discrepant outcome reporting is uncertain . Complete reporting of outcomes in systematic review abstract s is associated with statistical significance of the results for those outcomes . Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results . Modifications that occur once the review has commenced , along with their justification , should be clearly reported . Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results . The lack of research on selective inclusion of results in systematic review s needs to be addressed and studies that avoid the method ological weaknesses of existing research are also needed Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 BACKGROUND As many as 70 % of smokers with acute myocardial infa rct ion ( AMI ) continue to smoke after hospital discharge despite high rates of inpatient smoking cessation counseling . Supportive contact after discharge improves quit rates but is rarely used . METHODS Using data from a meta- analysis of r and omized trials of smoking cessation interventions and other published sources , we developed a Monte Carlo model to project health and economic outcomes for a hypothetical US cohort of 327,600 smokers hospitalized with AMI . We compared routine care , consisting of advice to quit smoking , with counseling with supportive follow-up , consisting of routine care and follow-up telephone calls from a nurse after discharge . Primary outcomes were number of smokers , AMIs , and deaths averted ; health care and productivity costs ; cost per quitter ; and cost per quality -adjusted life-year . RESULTS Implementation of smoking cessation counseling with follow-up contact for the 2010 cohort of hospitalized smokers would create 50,230 new quitters , cost $ 27.3 million in nurse wages and material s , and prevent 1380 nonfatal AMIs and 7860 deaths . During a 10-year period , it would save $ 22.1 million in reduced hospitalizations but increase health care costs by $ 166.4 million , primarily through increased longevity . Productivity costs from premature death would fall by $ 1.99 billion and nonmedical expenditures would increase by $ 928 million , for a net positive value to society of $ 894 million . The program would cost $ 540 per quitter considering only intervention costs . Cost-effectiveness would be $ 5050 per quality -adjusted life-year . Results were sensitive to the utility and incidence of nonfatal AMI and the potential effect of pharmacotherapies . CONCLUSION Smoking cessation counseling with supportive contact after discharge is potentially cost-effective and may reduce the incidence of smoking and its associated adverse health events and social costs Background Chronic obstructive pulmonary disease ( COPD ) remains a significant public health burden . Non-invasive ventilation ( NIV ) is a method of supported breathing used as st and ard care for acutely unwell patients in hospital with COPD , but there is uncertainty around the potential benefits of using NIV in the treatment of stable patients in a non-hospital setting . This is a protocol for systematic review s of the clinical and cost-effectiveness of NIV in this context , being undertaken in support of a model based economic evaluation . Methods / Design St and ard systematic review methods aim ed at minimising bias will be employed for study identification , selection and data extraction for both the clinical and economic systematic review s. Bibliographic data bases ( for example MEDLINE , EMBASE ) and ongoing trials registers will be search ed from 1980 onwards . The search strategy will combine terms for the population with those for the intervention . Studies will be selected for review if the population includes adult patients with COPD and hypercapnic respiratory failure , however defined . Systematic review s , r and omised controlled trials and observational studies ( with n > 1 ) will be included , and quality assessment will be tailored to the different study design s. The primary outcome measures of interest are survival , quality of life , and healthcare utilisations ( hospitalisation and Accident and Emergency attendances ) . Meta-analyses will be undertaken where clinical and method ological homogeneity exists , supported by predefined subgroup analyses where appropriate . A systematic review of the evidence on the cost-effectiveness of non-hospital NIV will be completed , and a model-based cost-utility analysis undertaken to determine the cost-effectiveness of non-hospital-based NIV compared with st and ard care . Discussion These review s will attempt to clarify the clinical effectiveness of non-hospital NIV in COPD patients as well as the cost-effectiveness . The findings may indicate whether NIV in a non-hospital setting should be considered more routinely in this patient group , and what the likely cost implication s will be . PROSPERO registration 2012:CRD42012003286 Background Community pharmacists can deliver health care advice at an opportunistic level , related to prescription or non-prescription medicines and as part of focused services design ed to reduce specific risks to health . Obesity , smoking and excessive alcohol intake are three of the most significant modifiable risk factors for morbidity and mortality in the UK , and interventions led by community pharmacists , aim ed at these three risk factors , have been identified by the government as public health priorities . In 2008 , the Department of Health for Engl and stated that ‘ a sound evidence base that demonstrates how pharmacy delivers effective , high quality and value for money services is needed ’ ; this systematic review aims to respond to this requirement . Methods / design We will search the data bases MEDLINE , Embase , CINAHL , PsycINFO , Social Sciences Citation Index , ASSIA , IBSS , Sociological Abstract s , Scopus and NHS Economic Evaluation Data base for studies that have evaluated interventions based on community pharmacies that aim to target weight management , smoking cessation and alcohol misuse . We will include all r and omised controlled trials ( RCTs ) , non-r and omised controlled trials ( N RCTs ) , controlled before-after studies ( CBAs ) and interrupted time series ( ITS ) and repeated measures studies . Data from included studies will be extracted by two independent review ers and will include study details methods , results , intervention implementation/costs and method ological quality . Meta- analysis will be conducted if appropriate ; if not , the synthesis will be restricted to a narrative overview of individual studies looking at the same question . Discussion The review aims to summarise the evidence base on the effectiveness of community pharmacy interventions on health and health behaviours in relation to weight management , smoking cessation and alcohol misuse . It will also explore if , and how , socio-economic status , gender , ethnicity and age moderate the effect of the interventions and will describe how the interventions included in the review have been organised , implemented and delivered , since context is an important factor governing the success of public health interventions . The findings from this review will have an impact on the commissioning of public health services aim ing to promote healthy weight , smoking cessation and prevent excessive alcohol consumption . Systematic review registration The review has been registered with PROSPERO ( registration no. CRD42013005943 ) . Available at : http://www.crd.york.ac.uk/ prospero /display_record.asp?ID = CRD42013005943 S ystematic review s are relied upon by clinicians and policymakers as high- quality evidence for decision-making . In some hierarchies of evidence quality , systematic review s are ranked at the top , higher than r and omized controlled trials . A properly conducted systematic review that is based on high- quality articles provides very strong evidence ; policymakers recognize this value and solicit many such review s. Busy clinicians rely on well-executed systematic review s to quickly synthesize the literature and guide them in managing patients . However , there are important inherent weaknesses that can limit the quality of systematic review s and can lead to erroneous conclusions . Consumers of systematic review s should approach them with a healthy sense of skepticism . Unfortunately , many of these weaknesses may not be obvious to the various stakeholders who routinely invest their trust in such review s. The first bias one encounters is inherent in the research enterprise . Generally , research ers design studies to demonstrate maximum effect ; hence they are careful about the population selected , the interventions tested , and the outcomes assessed . For example , interventions are often tested in population s that are at high risk for experiencing the outcome in question and are likely to respond to the intervention . Not only can this make results difficult to generalize , but it often results in studies that overstate the benefit ; subsequent studies frequently find less benefit . This is particularly common when the pool of available studies consists of small , single-center investigations , trials that are particularly likely to show large effects . While usually not intentional , the combination of careful selection of population and outcomes can distort clinical research and obscure truth . This inherent bias in the research enterprise can not be fixed ; however , if there are a sufficient number of studies , conducted across different setting s and population s , this problem can be partially ameliorated with systematic review s. Systematic review s are vulnerable to a number of biases . First , the question may not be well-defined . A marker of a high- quality systematic review is the inclusion of a purpose statement in which the specific research question is clearly articulated . Specificity is key : what are they willing to accept as evidence , what population , what intervention , what duration , what doses , what outcomes and when ? Second , the search strategy should be broad enough to reassure readers that no studies were left out . Research ers commonly limit their search to English- language articles . However , there is no difference between the quality of articles in English and those in other language s , and limiting the search to English-only should be a red flag to readers . The bibliographies of retrieved articles should also be review ed . All search strategies should include input from an experienced medical librarian . Third , the quality of included articles must be carefully assessed . The higher the quality of articles that provide the bulk of the systematic review ’s conclusions , the more confident readers can be in those conclusions . Readers should be wary of review s that are based on observational data or uncontrolled clinical trials . A statistical package will analyze whatever data the analyst feeds it , and will provide an estimate of an overall effect and a 95 % confidence interval . This can mislead readers into believing that our underst and ing of the effect is more concrete than it is . Pooling of observational data can lead to answers that differ material ly from the results of r and omized controlled trials . Readers should also be wary of systematic review s built on low sample numbers , either few studies or small sample s within each study . The number of studies necessary to produce believable results is an area of ongoing debate . A recent article discussed the benefits of  Trial Sequential Analysis ( TSA )  , a method that allows metaanalysts to determine the likelihood that the review contains either a type I error ( finding a difference that does not exist ) or a type II error ( reporting no difference when in fact one exists ) . TSA theory is similar to the principles governing stopping rules for interventional trials . It takes the total sample size and the size of the effect , and establishes boundaries . These boundaries provide confidence that the sample size is large enough to avoid type I or II errors . We strongly recommend routinely including them in meta-analyses . Fourth , very careful attention must be paid to the issue of publication bias . Most readers recognize that studies with nonsignificant results face greater publication hurdles . This is a wellrecognized phenomenon ; protocol s with non-significant results are both less likely to be published and , when published , more likely to encounter significant delays than studies with significant Published online December 12 ,
This study provides robust evidence supporting the cost-effectiveness of smoking cessation programs for hospitalized patients .
In addition , the results indicated that the degree of cost-effectiveness of the inpatient smoking cessation program might not be related to either the components of the program or method ological variations in the cost-effectiveness analysis .
This systematic review examined the characteristics of published cost-effectiveness analyses of  inpatient smoking cessation programs  and assessed the method ological quality of the selected studies , to provide policymakers with economic evidence for this type of program .