Patients as Mercenaries?: The Ethics of Using Financial Incentives in the War on Unhealthy Behaviors Design and baseline characteristics of participants in the TRial of Economic Incentives to Promote Physical Activity (TRIPPA): a randomized controlled trial of a six month pedometer program with financial incentives. Coupling Financial Incentives With Direct Mail in Population-Based Practice Financial incentives for smoking cessation in low-income smokers: study protocol for a randomized controlled trial The Use of Physician Financial Incentives and Feedback to Improve Pediatric Preventive Care in Medicaid Managed Care Premium-Based Financial Incentives Did Not Promote Workplace Weight Loss In A 2013-15 Study. Effects of Financial Incentives on Saving Outcomes and Material Well-Being: Evidence From a Randomized Controlled Trial in Uganda. Design and baseline characteristics of participants in the Enhancing Physical Activity and Reducing Obesity through Smartcare and Financial Incentives (EPAROSFI): A pilot randomized controlled trial. Incentives in Diabetic Eye Assessment by Screening (IDEAS): study protocol of a three-arm randomized controlled trial using financial incentives to increase screening uptake in London A Pilot Randomized Trial of Financial Incentives or Coaching to Lower Serum Phosphorus in Dialysis Patients. Effects of financial incentives for the purchase of healthy groceries on dietary intake and weight outcomes among older adults: A randomized pilot study Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol. The effect of physician disclosure of financial incentives on trust. Long-term effects of interventions for weight loss using food provision and monetary incentives. Using behavioral economic theory to increase use of effective contraceptives among opioid-maintained women at risk of unintended pregnancy. From Outcomes Research to Disease Management: A Guide for the Perplexed The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial. Pilot Study to Test the Effectiveness of Different Financial Incentives to Improve Medication Adherence Are financial incentives cost-effective to support smoking cessation during pregnancy? Public views on determinants of health, interventions to improve health, and priorities for government. Strategies for maximizing consent rates for child dental health surveys: a randomised controlled trial Economic Analysis of Health Care Technology: A Report on Principles
Consider the following paradox : few people would balk if research ers offered smokers $ 1,000 to participate in a year-long r and omized trial of a smoking cessation intervention , yet many would find it distasteful for a large employer to pay its smoking employees an extra $ 1,000 if they remained smoke-free for one year . Such discrepant judgments are underst and able from the perspective of classical economics . Research participants merit compensation for the risks and opportunity costs they endure in the service of public health , whereas individuals should need no reward for promoting their own well being . However , contrary to traditional theories of rationality , people frequently fail to make health-promoting choices , particularly when such choices require short-term sacrifices to foster long-term goals .1,2 Thus , corporate and government health plan leaders are increasingly applying extrinsic motivations such as financial incentives and other programs to augment health – particularly cardiovascular health – while hopefully increasing productivity and restraining costs.3 , 4 Early evidence suggests that financial incentives can effectively promote the cardioprotective behaviors of smoking cessation,5 , 6 weight loss,7 , 8 and cholesterol reduction.9  Incentives are also currently being studied as a means of promoting warfarin adherence.10 Although the results of these early studies are promising , further research is needed to determine which incentive structures and amounts are optimal , assess the ability of incentives to produce sustained behavior changes , and evaluate the cost-effectiveness of implementing incentive programs  . Ethical dimensions of the incentives themselves are also in need of further analysis . For example , some have charged that financial incentive programs are coercive , inequitable , and inconsistent with shared social values.11 Others have even suggested that implementing incentive programs serves to punish patients for their illnesses.12 In this essay , we outline the rationale for incentive programs to promote cardiovascular health , identify the ethical arguments that have been used to challenge such programs , and assess the merits of these arguments Non-communicable diseases ( NCDs ) are emerging as the predominant global health challenge of this century . Physical inactivity is one of the primary risk factors for NCDs . Therefore , increasing physical activity levels is a public health imperative . The arrival of affordable wearable technologies , such as wireless pedometers , provides one strategy for encouraging walking . However , the effectiveness of these technologies in promoting sustained behavior change has not been established . Insights from economics suggest that incentives may be a useful strategy for increasing maintenance and effectiveness of behavior change interventions , including physical activity interventions that rely on wearable technologies . The aim of this trial is to test the effectiveness of a common wireless pedometer with or without one of two types of incentives ( cash or donations to charity ) for reaching weekly physical activity goals . We present here the design and baseline characteristics of participants of this four arm r and omized controlled trial . 800 full-time employees ( desk-bound office workers ) belonging to 15 different worksites ( on average , 53 ( sd : 37 ) employees at each worksite ) were successfully r and omized to one of four study arms . If shown to be effective , wearable technologies in concert with financial incentives may provide a scalable and affordable health promotion strategy for governments and employers seeking to increase the physical activity levels of their constituents Financial incentives are being used increasingly to encourage a wide array of health behaviors because of their well-established efficacy . However , little is known about how to translate incentive-based strategies to public health practice geared toward improving population -level health , and a dearth of research exists on how individuals respond to incentives through public health communication strategies such as direct mail . This study reports results of a population -based r and omized controlled trial testing a direct mail , incentive-based intervention for promoting mammography uptake . The study population was composed of a r and om sample of Minnesota women enrolled in Medicare fee-for-service and overdue for breast cancer screening . Participants ( N = 18,939 ) were r and omized into three groups : ( 1 ) Direct Mail only , ( 2 ) Direct Mail plus Incentive , and ( 3 ) Control . Both direct mail groups received two mailers with a message about the importance of mammography ; however , Mail plus Incentive mailers also offered a $ 25 incentive for getting a mammogram . Logistic regression analyses measured intervention effects . Results showed the odds for receiving mammography were significantly higher for the Direct Mail plus Incentive group compared with both Direct Mail only and Control groups . The use of incentives also proved to be cost-effective . Additionally , the Direct Mail only group was more likely to receive mammography than the Control group . Findings offer experimental evidence on how the population -based strategy of direct mail coupled with a financial incentive can encourage healthy behavior , as well as how incentive-based programs can be translated into health promotion practice aim ed at achieving population -level impact Abstract Background Tobacco smoking is the leading avoidable cause of death in high-income countries . The smoking-related disease burden is borne primarily by the least educated and least affluent groups . Thus , there is a need for effective smoking cessation interventions that reach to , and are effective in this group . Research suggests that modest financial incentives are not very effective in helping smokers quit . What is not known is whether large financial incentives can enhance longer-term ( 1 year ) smoking cessation rates , outside clinical and workplace setting s . Trial design A r and omized , parallel groups , controlled trial . Methods Participants : Eight hundred low-income smokers in Switzerl and ( the less affluent third of the population , based on fiscal taxation ) . Intervention : A smoking cessation program including : ( a ) financial incentives given during 6 months ; and ( b ) Internet-based counseling . Financial rewards will be offered for biochemically verified smoking abstinence after 1 , 2 , and 3 weeks and 1 , 3 , and 6 months , for a maximum of 1,500 CHF ( 1,250 EUR , 1,500 USD ) for those abstinent at all time-points . All participants , including controls , will receive Internet-based , individually-tailored , smoking cessation counseling and self-help booklets , but there will be no in-person or telephone counseling , and participants will not receive medications . The control group will not receive financial incentives . Objective : To increase smoking cessation rates . Outcome : Smoking abstinence after 6 and 18 months , not contradicted by biochemical tests . We will assess relapse after the end of the intervention , to test whether 6-month effects translate into sustained abstinence 12 months after the incentives are withdrawn . R and omization : Will be done using sealed envelopes drawn by participants . Blinding : Is not possible in this context . Discussion Smoking prevention policies and interventions have been least effective in the least educated , low-income groups . Combining financial incentives and Internet-based counseling is an innovative approach that , if proven acceptable and effective , could be later implemented on a large scale at a reasonable cost , decrease health disparities , and save many lives . Trial registration Current Controlled Trials IS RCT N04019434 Objective . Immunizations and other cost-effective preventive services remain underused by many children , especially those living in poverty . Given the effectiveness of provider-based tracking systems and the widespread use by managed care organizations of financial incentives to influence physician practice patterns , we design ed and tested an intervention combining these strategies . We studied whether a system of semiannual assessment and feedback , coupled with financial incentives , could improve pediatric preventive care in a Medicaid health maintenance organization ( HMO ) . Methodology . We r and omly assigned primary care sites serving children in a Medicaid HMO to one of three groups : a feedback group ( where physicians received written feedback about compliance scores ) , a feedback and incentive group ( where physicians received feedback and a financial bonus when compliance criteria were met ) , and a control group . We evaluated compliance with pediatric preventive care guidelines  through semiannual chart audits during the years 1993 to 1995 . Results . Compliance with pediatric preventive care improved dramatically in the study period . Repeated measures ANOVA demonstrated a significant increase in all three study groups throughout the time in total compliance scores ( from 56%–73 % ) , as well as scores for immunizations ( from 62%–79 % ) and other preventive care ( from 54%–71 % ) . However , no significant differences were observed between either intervention group and the control group , nor were there any interaction ( group-by-time ) effects . Conclusions . Feedback to physicians , with or without financial incentives , did not improve pediatric preventive care in this Medicaid HMO during a time of rapid , secular improvements in care . Possible explanations include the context and timing of the intervention , the magnitude of the financial incentives , and lack of physician awareness of the intervention Employers commonly use adjustments to health insurance premiums as incentives to encourage healthy behavior , but the effectiveness of those adjustments is controversial . We gave 197 obese participants in a workplace wellness program a weight loss goal equivalent to 5 percent of their baseline weight . They were r and omly assigned to a control arm , with no financial incentive for achieving the goal , or to one of three intervention arms offering an incentive valued at $ 550 . Two intervention arms used health insurance premium adjustments , beginning the following year ( delayed ) or in the first pay period after achieving the goal ( immediate ) . A third arm used a daily lottery incentive separate from premiums . At twelve months there were no statistically significant differences in mean weight change either between the control group ( whose members had a mean gain of 0.1 pound ) and any of the incentive groups ( delayed premium adjustment , -1.2 pound ; immediate premium adjustment , -1.4 pound ; daily lottery incentive , -1.0 pound ) or among the intervention groups . The apparent failure of the incentives to promote weight loss suggests that employers that encourage weight reduction through workplace wellness programs should test alternatives to the conventional premium adjustment approach by using alternative incentive design s , larger incentives , or both The use of savings products to promote financial inclusion has increasingly become a policy priority across sub-Saharan Africa , yet little is known about how families respond to varying levels of savings incentives and whether the promotion of incentivized savings in low-re source setting s may encourage households to restrict expenditures on basic needs . Using data from a r and omized controlled trial in Ug and a , we examine : 1 ) whether low-income households enrolled in an economic-empowerment intervention consisting of matched savings , workshops , and mentorship  reduced spending on basic needs and 2 ) how varied levels of matching contributions affected household savings and consumption behavior . We compared primary school-attending AIDS-affected children ( N = 1,383 ) r and omized to a control condition with two intervention arms with differing savings-match incentives : 1:1 ( Bridges ) and 1:2 ( Bridges PLUS ) . We found that : 1 ) 24 months post-intervention initiation , children in Bridges and Bridges PLUS were more likely to have accumulated savings than children in the control condition ; 2 ) higher match incentives ( Bridges PLUS ) led to higher deposit frequency but not higher savings in the bank ; 3 ) intervention participation did not result in material hardship ; and 4 ) in both intervention arms , participating families were more likely to start a family business and diversify their assets BACKGROUND An activity tracker combined with a smartphone application ( smartcare ) may help people track and receive feedback on their own activities . However , activity trackers themselves generally fail to drive long-term sustained engagement for a majority of users . One potential strategy for increasing the effectiveness of smartcare is through the use of incentives . The purpose of this pilot r and omized trial is to test the feasibility of our intervention and to assess the extent to which smartcare with or without financial incentives can increase physical activity levels and reduce weight over a 12-week period . METHODS / DESIGN This study employs a three-arm , open-label r and omized controlled trial design : control ( st and ard basic education ) , smartcare , and smartcare plus financial incentives .  Male university students with body mass index ≥ 27 are enrolled . Our primary and secondary endpoints are the amount of weight loss and the level of physical activity respectively . The weight loss goal is 3 % of baseline at week 4 , 5 % at week 8 , and 7 % at week 12 . The daily physical activity goal was individualized according to the participants ' weight . Process incentives are accumulated when participants met daily physical activity goals , and outcome incentives are provided when they met weight reduction goals . DISCUSSION Given the global increase in physical inactivity and obesity , there is a growing need for effective , scalable , and affordable health promotion strategies . Our proof-of-concept study will provide the evidence for the combination of rising health promotion technology of activity trackers and smartphone applications with the modern concept of behavioral economics using financial incentives Background Diabetes is an increasing public health problem in the UK and globally . Diabetic retinopathy is a microvascular complication of diabetes , and is one of the leading causes of blindness in the UK working age population . The diabetic eye screening programme in Engl and aims to invite all people with diabetes aged 12 or over for retinal photography to screen for the presence of diabetic retinopathy . However , attendance rates are only 81 % , leaving many people at risk of preventable sight loss . Methods This is a three arm r and omized controlled trial to investigate the impact of different types of financial incentives ( based on principles from behavioral economics ) on increasing attendance at  diabetic eye screening appointments in London . Eligible participants will be aged 16 or over , and are those who have been invited to screening appointments annually , but who have not attended , or telephoned to rearrange an appointment , within the last 24 months . Eligible participants will be r and omized to one of three conditions:1.Control condition ( usual invitation letter)2.Fixed incentive condition ( usual invitation letter , including a voucher for £ 10 if they attend their appointment)3.Probabilistic incentive condition ( invitation letter , including a voucher for a 1 in 100 chance of winning £ 1000 if they attend their appointment ) . Participants will be sent invitation letters , and the primary outcome will be whether or not they attend their appointment . One thous and participants will be included in total , r and omized with a ratio of 1.4:1:1 . In order to test whether the incentive scheme has a differential impact on patients from different demographic or socio-economic groups , information will be recorded on age , gender , distance from screening center , socio-economic status and length of time since they were last screened . A cost-effectiveness analysis will also be performed . Discussion This study will be the first trial of financial incentives for improving uptake of diabetic eye screening . If effective , the intervention may suggest a cost-effective way to increase screening rates , thus reducing unnecessary blindness . Trial registration IS RCT N14896403 , 25 February OBJECTIVE Among chronic hemodialysis patients , hyperphosphatemia is common and associated with mortality . Behavioral economics and complementary behavior-change theories may offer valuable approaches to achieving phosphorus ( PO4 ) control . The aim was to determine feasibility of implementing financial incentives and structured coaching to improve PO4 in the hemodialysis setting . DESIGN AND METHODS This pilot r and omized controlled trial was conducted in 3 urban dialysis units for 10 weeks among 36 adults with elevated serum PO4 ( median > 5.5 mg/dL over 3 months ) . INTERVENTIONS Twelve participants each were r and omized to : ( 1 ) financial incentives for lowering PO4 , ( 2 ) coaching about dietary and medication adherence , or ( 3 ) usual care . PO4 was measured during routine clinic operations . Each incentives arm participant received the equivalent of $ 1.50/day if the PO4 was ≤5.5 mg/dL or > 5.5 mg/dL but decreased ≥0.5 mg/dL since the prior measurement . The coach was instructed to contact coaching arm participants at least 3 times per week . MAIN OUTCOME MEASURES The outcome measures included : ( 1 ) enrollment rate , ( 2 ) dropout rate , and ( 3 ) change in PO4 from beginning to end of 10-week intervention period . RESULTS Of 66 eligible patients , 36 ( 55 % ) enrolled . Median age was 53 years , 83 % were black race , and 78 % were male . Median baseline PO4 was 6.0 ( interquartile range 5.6 , 7.5 ) . Using stratified generalized estimation equation analyses , the monthly decline in PO4 was -0.32 mg/dL ( 95 % CI -0.60 , -0.04 ) in the incentives arm , -0.40 mg/dL ( -0.60 , -0.20 ) in the coaching arm , and -0.24 mg/dL ( -0.60 , 0.08 ) in the usual care arm . No patients dropped out . All intervention arm participants expressed interest in receiving similar support in the future . CONCLUSIONS This pilot trial demonstrated good feasibility in enrollment and implementation of novel behavioral health strategies to reduce PO4 in dialysis patients Providing financial incentives can be a useful behavioral economics strategy for increasing fruit and vegetable intake among consumers . It remains to be determined whether financial incentives can promote intake of other low energy-dense foods and if consumers who are already using promotional tools for their grocery purchases may be especially responsive to receiving incentives . This r and omized controlled trial tested the effects of offering financial incentives for the purchase of healthy groceries on 3-month changes in dietary intake , weight outcomes , and the home food environment among older adults . A secondary aim was to compare frequent coupon users ( FCU ) and non-coupon users ( NCU ) on weight status , home food environment , and grocery shopping behavior .  FCU ( n = 28 ) and NCU ( n = 26 ) were r and omly assigned to either an incentive or a control group . Participants in the incentive group received $ 1 for every healthy food or beverage they purchased . All participants completed 3-day food records and a home food inventory and had their height , weight , and waist circumference measured at baseline and after 3 months . Participants who were responsive to the intervention and received financial incentives significantly increased their daily vegetable intake ( P = 0.04 ) . Participants in both groups showed significant improvements in their home food environment ( P = 0.0003 ) . No significant changes were observed in daily energy intake or weight-related outcomes across groups ( P < 0.12 ) . FCU and NCU did not differ significantly in any anthropometric variables or the level at which their home food environment may be considered ' obesogenic ' ( P > 0.73 ) . Increased consumption of vegetables did not replace intake of more energy-dense foods . Incentivizing consumers to make healthy food choices while simultaneously reducing less healthy food choices may be important Despite the high risk of tobacco-related morbidity and mortality among low-income persons , few studies have connected low-income smokers to evidence -based treatments . We will examine a smoking cessation intervention integrated into primary care . To begin , we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation . Next , we will conduct a r and omized controlled trial combining two interventions : patient navigation and financial incentives . The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital . Our intervention will encourage patients to utilize existing smoking cessation re sources ( e.g. , quit lines , smoking cessation groups , discussing smoking cessation with their primary care providers ) . To test our intervention , we will conduct a r and omized controlled trial , r and omizing 352 patients to the intervention condition ( patient navigation and financial incentives ) or an enhanced traditional care control condition .  We will perform follow-up at 6 , 12 , and 18 months following the start of the intervention . Evaluation of the intervention will target several implementation variables : reach ( participation rate and representativeness ) , effectiveness ( smoking cessation at 12 months [ primary outcome ] ) , unintended consequences ( e.g. , purchase of illicit substances with incentive money ) , adoption ( use of intervention across primary care suites ) , implementation ( delivery of intervention ) , and maintenance ( smoking cessation after conclusion of intervention ) . Improving the implementation of smoking cessation interventions in primary care setting s serving large underserved population s could have substantial public health impact , reducing cancer-related morbidity/mortality and associated health disparities BACKGROUND Many physicians receive financial incentives to limit their ordering of expensive tests and procedures . While Medicare m and ates disclosure of incentives , it is not clear how to inform patients without undermining trust . METHODS Our objective was to determine public opinion about physician  disclosure of financial incentives and how this might be best communicated to patients . The 2002 General Social Survey included 2765 interviews from a probability sample of English-speaking US households . The interview included questions about financial incentives and an audiotaped scenario of a physician discussing the impact of financial incentives on ordering a magnetic resonance image . Respondents heard 1 of 6 r and omly selected disclosure strategies . The measurements included ratings of trust , satisfaction , agreement with the physician 's decision , and likelihood of remaining with the physician/health plan or seeking a second opinion . RESULTS Nearly half ( 48.8 % ) of respondents had previously heard of financial incentives to limit test ordering . Of the respondents , 94.8 % wanted to be told about incentives , at the time of enrollment in a health plan ( 80.5 % ) , by a health plan representative ( 44.8 % ) , their physician ( 17.1 % ) , or both ( 38.1 % ) . Of the 6 different disclosure strategies , " addressing emotions " and " negotiation " were associated with the best outcomes , while " common enemy " and " denying influences " were most negatively perceived . Black and Hispanic subjects were less likely to express satisfaction or trust and more likely to disenroll or seek a second opinion . CONCLUSIONS The public wants information about physician financial incentives . Specific communication styles enhance how this information is conveyed to patients , increasing trust and supporting the physician-patient relationship One hundred seventy-seven men and women who had participated in an 18-month trial of behavioral interventions involving food provision and financial incentives  were examined 12 months later . Food provision , but not financial incentives , led to better weight loss than st and ard behavioral treatment during the 18-month trial , but over 12 additional months of no-treatment follow-up , all treated groups gained weight , maintained only slightly better weight losses than a no-treatment control group , and did not differ from each other . Weight loss success during both active treatment and maintenance was associated with increase in exercise , decrease in percentage of energy from fat , increase in nutrition knowledge , and decrease in perceived barriers to adherence . Obesity treatment research should focus on developing better ways to maintain changes in the diet and exercise behaviors needed for sustained weight loss OBJECTIVE An unsettling aspect of the US opioid epidemic is the high rate of in utero exposure , especially since most of these pregnancies are unintended , due in part to low rates of effective contraceptive use among opioid-using women . This study tested an intervention informed by behavioral economic theory and aim ed at promoting effective contraceptive use among opioid-maintained women at risk of unintended pregnancy in the Burlington , VT , area between 2011 and 2013 . METHODS Thirty-one women were assigned ( initial 5 consecutively , subsequent 26 r and omly ) to either usual care or an experimental intervention . Participants in usual care received condoms , a dose of emergency contraception , and referral to local providers . Participants in the experimental condition received usual care plus the World Health Organization 's contraception initiation protocol , including free prescription contraceptives , and financial incentives for attending 13 follow-up visits over 6months to help manage side effects and other issues . RESULTS Significantly more women in the experimental vs. usual care control conditions initiated prescription contraceptive use ( 100 % vs. 29 % ) and reported prescription contraceptive use at 1-month ( 63 % vs. 13 % ) , 3-month ( 88 % vs. 20 % ) , and 6-month ( 94 % vs. 13 % ) assessment s. None of the experimental condition participants became pregnant during the 6-month protocol vs. three women ( 20 % ) in the control condition . CONCLUSIONS These results provide the first experimental evidence supporting the efficacy of an intervention for increasing prescription contraceptive use among opioid-maintained women at risk of unintended pregnancy The well-being of the soul can be obtained only after that of the body has been secured , said M aim onides in his classical treatise [ 1 ] . This early comment pre date s the current appreciation of the effect of physical health on quality of life . Outcomes research has exp and ed dramatically in recent years [ 2 - 5 ] through multidisciplinary efforts involving health services research ers , epidemiologists , economists , sociologists , statisticians , and ethicists . Driving this interest are concerns about rapidly increasing health care costs , growing consumer involvement in medical decision making , and incorporation of information systems into clinical medicine . The health care industry has also increased its focus on efficiency and productivity , with particular emphasis on outcomes . The latest concept in this field , disease management , refers to the use of an explicit systematic population -based approach to identify persons at risk , intervene with specific programs of care , and measure clinical and other outcomes . Disease management is not new ; for centuries , clinicians have been identifying and treating patients using information gleaned from their training , the medical literature , and personal experience . What is new about the current model of disease management is that it does much more than evaluate known practice s and suggest guidelines . It is a systematic information-driven approach in which clinical encounters are computerized , summarized , and shared ; opportunities for intervention are not always detected solely at the bedside , but sometimes from a central data -base ; practice guidelines may be implemented by computer screens in the practice setting ; and initiatives are measured and compared in terms of health outcomes . At the core of disease management are principles described as outcomes research , an evolving and somewhat embryonic field . Confusion has arisen over terminology and the application of principles to the management of patients . We identify core concepts and highlight some issues that become apparent as outcomes principles are applied to practice . Measurement of Outcomes An important aspect of disease management is the ability to measure and report health outcomes . The movement to collect this information has recently escalated , stimulated by federal initiatives to compare mortality among hospitals [ 6 , 7 ] , by comparative outcomes studies [ 8 ] , and by payers seeking to improve quality and reduce costs [ 9 ] . Donabedian [ 10 - 12 ] described quality health care as an optimal triad of structure , process , and outcomes . And erson and colleagues [ 13 ] extended this model by suggesting that relations among these factors should guide decision making . The outcome measures have evolved from simple dichotomous ones such as survival or occurrence of a clinical event to patient-oriented measures such as satisfaction , quality of life , and functional status . The term outcomes has been linked to different measures , ranging from physiologic values to quality of life assessment s. One approach to taxonomy is shown in Table 1 . The reporting of outcomes may need to differ , depending on the priorities of those examining the data . A clinician is likely to be primarily interested in clinical or humanistic outcomes , whereas a health plan administrator may be interested in economic ones . Patients are interested in humanistic outcomes and have trouble interpreting clinical outcomes . As clinicians ' financial risk increases , they are also developing greater interest in economic outcomes . Current disease management programs include mixtures of all measures . Table 1 . Types of Outcome Measures and Selected Examples Several points should be emphasized as these measures gain broader application . Selection of specific measures is currently a somewhat arbitrary process . For asthma , for example , several disease-specific measures of quality of life are available [ 14 - 17 ] . One way to distinguish among these measures is to examine the evidence behind the development of each measure : Has each one been vali date d ? This is now a st and ardized process of item generation , item reduction , reproducibility , responsiveness , and validation [ 18 , 19 ] ; however , multiple question naires can meet these criteria and still leave the clinician confused . Many outcomes measures were developed for use in population surveys or clinical trials and not for use in monitoring individual patients . The within-person variability can be great , but it is often offset with aggregate data ; thus , in the context of disease management , some measures must be used with care . Even when measures are aggregated , statistical power may be insufficient to detect a significant improvement in outcomes . For example , in a modestly sized health plan with 25 000 members , one might estimate that 150 persons have diabetes and use insulin . Even if all 150 participated in a program that reduced the number of diabetes-related complications by 50 % through improved diet , exercise , and appropriate use of insulin , the statistical power would be too low to document the program value compared with complication rates with a previous program . Thus , not all outcomes can be collected on all population s ; if outcomes are measured , statistical issues need sufficient attention . Finally , the interpretation of the change in outcomes is not yet clear for all measures . For example , what is the meaning of a 4-point change on a 100-point quality -of-life scale ? Is a $ 0.50 increase in the per-member per-month charge enough to warrant a disease management program ? Research ers attempting to define clinical significance are beginning to address these issues by anchoring degree of change to other events [ 20 - 24 ] . For example , Brook and colleagues [ 25 ] noted that a three-point difference on a st and ardized mental health scale was analogous to being laid off from a job . Considerable additional research into the meaning and application of outcomes is needed . Effectiveness Studies The distinction between effectiveness and efficacy is critical to disease management ; treatments with proven efficacy do not always perform as well under conditions of typical clinical practice ( effectiveness ) . In most efficacy studies , highly specialized practitioners treat selected patients on tight protocol s in a setting in which both patients and practitioners have economic incentives to comply . In effectiveness studies , on the other h and , treatments can be viewed as they would be in usual setting s ( Table 2 ) [ 26 - 28 ] . Table 2 . Effectiveness Studies Compared with Efficacy Studies * Most therapies require evaluation of efficacy before being implemented . This evaluation generally requires a priori hypotheses , r and omization ( to eliminate selection bias and confounding ) , homogeneous patients at high risk for the outcome , experienced investigators who follow a protocol , a comparative measure such as placebo ( if ethical ) , and intensive follow-up to ensure compliance . Under these circumstances , if a treatment proves to be better than placebo ( or a comparative measure ) , one can be reassured that the treatment can work . However , questions may remain about the ability of the treatment to work adequately in a broader range of patients and in usual practice setting s in which both patients and providers face natural barriers to care . These issues are of central importance in assessing relative cost-effectiveness in the community . To address these questions , most effectiveness studies have been done as observational studies , wherein observed groups are not r and omly assigned to therapy and neither patients nor providers generally know that they are being studied ( usually retrospective studies ) . This eliminates issues related to inclusion of special patients and providers and allows the treatment to be observed as it is typically used . Selection bias , which occurs when patients are not r and omly assigned to alternative treatments , becomes potentially problematic , and adjustment for case mix and severity of illness becomes important . In response to this problem , prospect i ve effectiveness trials are beginning to emerge [ 29 - 31 ] . As in typical clinical trials , these trials include the development of a protocol with a priori hypotheses , recruitment of participants with informed consent , r and omization to eliminate selection bias , and routine collection of data at prespecified time periods . Prospect i ve effectiveness trials differ from typical clinical trials in that they enroll heterogeneous participants , use providers more similar to those who treat the disease , impose few protocol -driven interventions , and incorporate outcome measures relevant to the disease and delivery system . Such trials attempt to provide unbiased information in relation to selection factors while still addressing outcomes and effectiveness . In disease management , clinical trials are not always possible . When a health plan has developed a new clinical program , members may not feel comfortable having an intervention withheld , and employers may be unwilling to conduct a trial before disseminating the program . However , if the program is implemented without a concurrent comparison group , what remains is a before- and -after comparison ; within a rapidly changing health care environment , the aging of the population and other factors can confound results . This issue is an especially important method ologic challenge of program evaluation . Health Economic Evaluation The types of studies that are considered to be economic evaluations are shown in Table 3 . Of these , cost-effectiveness and costutility analyses overlap with outcomes research because economic measures are frequently related to outcomes such as mortality , quality of life , or value assigned to years of life saved ( or quality -adjusted life-years ) . Table 3 . Health Economic Evaluations Suppose the intervention is design ed for middle-aged persons with a disease that leads to death and only requires treatment for 3 years . If the therapy costs $ 3/d , the total cost of Background Seventy percent of women in Scotl and have at least one baby , making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised . By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight , asthma , attention deficit disorder and adult cardiovascular disease . In the UK , the NICE guidelines : ‘ How to stop smoking in pregnancy and following childbirth ’ ( June 2010 ) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit . Its first research recommendation was to determine : Within a UK context , are incentives an acceptable , effective and cost-effective way to help pregnant women who smoke to quit ? Design and methods This study is a phase II exploratory individually r and omized controlled trial comparing st and ard care for pregnant smokers with st and ard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and /or to quit smoking during pregnancy .  Participants ( n = 600 ) will be pregnant smokers identified at maternity booking who , when contacted by specialist cessation services , agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial . The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy . The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement . An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment . The research questions are : What is the likely therapeutic efficacy ? Are incentives potentially cost-effective ? Is individual r and omization an efficient trial design without introducing outcome bias ? Can incentives be introduced in a way that is feasible and acceptable ? Discussion This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter r and omized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit . Trial registration Current Controlled Trials IS RCT BACKGROUND Poor adherence to long-term antipsychotic injectable ( LAI ) medication in patients with psychotic disorders is associated with a range of negative outcomes . No psychosocial intervention has been found to be consistently effective in improving adherence . OBJECTIVES To test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives . DESIGN A cluster r and omised controlled trial with economic and nested qualitative evaluation . The intervention period lasted for 12 months with 24 months ' follow-up . The unit of r and omisation was mental health teams in the community . SETTING Community teams in secondary mental health care . PARTICIPANTS Patients with a diagnosis of schizophrenia , schizoaffective psychosis or bipolar illness , receiving ≤ 75 % of their prescribed LAI medication . In total , 73 teams with 141 patients ( intervention n = 78 and control n = 63 ) were included . INTERVENTIONS Participants in the intervention group received £ 15 for each LAI medication . Patients in the control group  received treatment as usual . MAIN OUTCOME MEASURES PRIMARY OUTCOME adherence to LAI medication  ( the percentage of received out of those prescribed ) . SECONDARY OUTCOMES percentage of patients with at least 95 % adherence ; clinical global improvement ; subjective quality of life ; satisfaction with medication ; hospitalisation ; adverse events ; and costs . Qualitative evaluation : semistructured interviews with patients in the intervention group and their clinicians . RESULTS PRIMARY OUTCOME outcome data were available for 131 patients .  Baseline adherence was 69 % in the intervention group and 67 % in the control group . During the intervention period , adherence was significantly higher in the intervention group than in the control group ( 85 % vs. 71 % ) [ adjusted mean difference 11.5 % , 95 % confidence interval ( CI ) 3.9 % to 19.0 % ; p = 0.003 ] . Secondary outcome : patients in the intervention group showed statistically significant improvement in adherence of at least 95 % ( adjusted odds ratio 8.21 , 95 % CI 2.00 to 33.67 ; p = 0.003 ) and subjective quality of life ( difference in means 0.71 , 95 % CI 0.26 to 1.15 ; p = 0.002 ) . Follow-ups : after incentives stopped , adherence did not differ significantly between groups , neither during the first 6 months ( adjusted difference in means -7.4 % , 95 % CI -17.0 % to 2.1 % ; p = 0.175 ) nor during the period from month 7 to month 24 ( difference in means -5.7 % , 95 % CI -13.1 % to 1.7 % ; p = 0.130 ) . Cost-effectiveness : the average costs of the financial incentives was £ 303 . Overall costs per patient were somewhat higher in the intervention group , but the difference was not significant . Semistructured interviews : the majority of patients and clinicians reported positive experiences with the incentives beyond their monetary value . These included improvement in the therapeutic relationship . The majority of both patients and clinicians perceived no negative impact after the intervention was stopped after 1 year . CONCLUSIONS Financial incentives are effective in improving adherence to LAI medication . Health-care costs ( including costs of the financial incentive ) are unlikely to be increased substantially by this intervention . Once the incentives stop , the advantage is not maintained . The experiences of both patients and clinicians are largely , but not exclusively , positive . Whether or not financial incentives are effective for patients with more favourable background , those on oral mediation or for shorter or longer time periods remains unknown . TRIAL REGISTRATION Current Controlled Trials IS RCT N77769281 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 70 . See the NIHR Journals Library website for further project information Background : Medication nonadherence affects health care costs , morbidity , and mortality . Concepts from behavioral economics can guide the development of interventions to improve medication adherence . Objective : To measure the relative effectiveness of 2 behavioral economic-based incentive structures to improve medication adherence . Methods : This r and omized controlled trial compared adherence among participants taking antihypertensive or antihyperlipidemic medications r and omized to usual care ( UC ) , guaranteed pay-out ( GPO ) incentives , or lottery incentives .  Daily adherence was measured over a 90-day period using electronic caps ( Medication Event Monitoring System [ MEMS ] ) . The GPO group received $ 30 up-front in a virtual account , with $ 0.50 deducted for each missed dose .  Lottery group participants were eligible for a weekly $ 50 drawing , but only if they had taken their medication as prescribed all week . An electronic survey assessed self-reported adherence . Statistical analysis included descriptive statistics , paired t tests , ANOVA , and Pearson ’s correlations . Results : In all , 36 participants were r and omized ( UC , n = 11 ; GPO , n = 14 ; lottery , n = 11 ) .  Mean percentage ( ±SD ) of days adherent during the incentive period was highest in the lottery group ( 96 % ± 5 % ) , followed by the GPO group ( 94 % ± 9 % ) and the UC group ( 94 % ± 9 % ) . There were no statistically significant differences among groups ( P > 0.05 ) . MEMS-measured adherence was not significantly correlated with a patient ’s self-reported adherence ( P > 0.05 ) at baseline but was correlated at 90-day follow-up ( P < 0.001 ) . Conclusions : Although no statistically significant differences in adherence were demonstrated in this small sample of highly adherent participants , larger studies in a more diverse population or with other medications might show otherwise AIMS To investigate the cost-effectiveness of up to £ 400 worth of financial incentives for smoking cessation in pregnancy as an adjunct to routine health care . DESIGN Cost-effectiveness analysis based on a Phase II r and omized controlled trial ( RCT ) and a cost-utility analysis using a life-time Markov model . SETTING The RCT was undertaken in Glasgow , Scotl and . The economic analysis was undertaken from the UK National Health Service ( NHS ) perspective . PARTICIPANTS A total of 612 pregnant women r and omized to receive usual cessation support plus or minus financial incentives of up to £ 400 vouchers ( US $ 609 ) , contingent upon smoking cessation . MEASUREMENTS Comparison of usual support and incentive interventions in terms of cotinine-vali date d quitters , quality -adjusted life years ( QALYs ) and direct costs to the NHS . FINDINGS The incremental cost per quitter at 34 - 38 weeks pregnant was £ 1127 ($1716).This is similar to the st and ard look-up value derived from Stapleton & West 's published ICER tables , £ 1390 per quitter , by looking up the Cessation in Pregnancy Incentives Trial ( CIPT ) incremental cost ( £ 157 ) and incremental 6-month quit outcome ( 0.14 ) . The life-time model result ed in an incremental cost of £ 17 [ 95 % confidence interval ( CI ) = -£93 , £ 107 ] and a gain of 0.04 QALYs ( 95 % CI = -0.058 , 0.145 ) , giving an ICER of £ 482/QALY ( $ 734/QALY ) . Probabilistic sensitivity analysis indicates uncertainty in these results , particularly regarding relapse after birth . The expected value of perfect information was £ 30 million ( at a willingness to pay of £ 30 000/QALY ) , so given current uncertainty , additional research is potentially worthwhile . CONCLUSION Financial incentives for smoking cessation in pregnancy are highly cost-effective , with an incremental cost per quality -adjusted life years of £ 482 , which is well below recommended decision thresholds OBJECTIVE There is increasing evidence about the importance of factors that impact health beyond health care and individual behavior , yet there is little public and policy discourse about these things in the United States . We surveyed Wisconsin adults to see what they think are the most important factors that affect health . We also examined which interventions they believe would improve health , and whether government should prioritize such interventions . METHODS A phone survey of a r and om sample of 1459 Wisconsin adults was conducted between September 2006 and February 2007 . RESULTS The Wisconsin public believes that health practice s , access to health care , and health insurance are the most important factors affecting health , and that health insurance is a high government priority . Other broader social and economic determinants of health , such as employment , social support , income , housing , and neighborhood factors are seen as less important to health . Although respondents believe that health practice s are important to health , they are less likely to suggest that government prioritize improving individual health practice s. Although the public believes the government should prioritize access to health care and health insurance , they are not as likely to support government implementing social or economic policies in order to improve health . CONCLUSION In light of research demonstrating the importance of social and economic determinants of health , and of ongoing public forums meant to raise awareness of these determinants of health , it will be important to track whether public opinion of Wisconsin adults changes over time to increase attention to the social and economic determinants of health and related policy initiatives Background Poor response rates can jeopardise the validity of the findings of epidemiological surveys . The aim of this study was to undertake a r and omised controlled trial to determine the effectiveness of different strategies for maximizing parental consent rates for dental health surveys of young children . Methods The trial took place within the 2007/2008 NHS Epidemiological Dental Health Survey of 5-year-old children in the North West of Engl and . Schools were r and omised to one of five interventions : multiple letters to parents ; promoting the research by providing additional information to parents and children ; a financial incentive to the school ; a financial incentive to the school administrator plus direct mailing to parents ; and a control intervention comprising of usual practice , that is a single letter home to parents via the children . Results A total of 335 schools ( 11,088 children ) were recruited . The mean percentage consent rates ranged from 47 % ( financial incentive to school administrator plus direct mailing ) to 63 % ( multiple letters ) . Pair-wise comparisons indicated that the multiple letter group had a statistically significantly greater consent rate than the financial incentive to the school administrator plus direct mailing group and promoting the research by providing additional information group , but was not statistically significantly different from the financial incentive to the school group and the control group . Conclusions There was little evidence to show that any of the five interventions made a significant difference to consent rates when compared to the control group . Financial incentives to schools were less effective than multiple reminder letters to parents . Trials should be built into surveys to test different interventions , in different context s to exp and the evidence base for improving consent rates in health surveillance programmes Preamble Although economic outcomes research is an evolving field in health services research , there are correct and incorrect ways to conduct and report on economic outcomes studies . Research practice s that help to minimize real or perceived bias will increase the quality and usefulness of such studies for those who sponsor , publish , and use them . Because of public concerns about the potential for bias in the design , analysis , and reporting of economic analyses of health care technology , we formed a task force to develop principles to enhance the credibility of these studies . The Task Force on Principles for Economic Analysis of Health Care Technology included participants from academia , the pharmaceutical industry , the public sector , and private research organizations . As health care re sources become increasingly constrained , the information used to make re source allocation decisions must be as reliable , valid , and free of bias as possible . Getting it right at the level at which economic results are produced will help to protect consumers and will advance the health of the public . Bias stems from two broad categories : lack of appropriate independence for research ers and lack of consensus about methods . We focused heavily on the first of these categories for two major reasons . First , few have yet considered the unique issues of research er independence in economic outcomes research [ 1 , 2 ] . Second , other investigators have begun to consider and define proper methods for economic outcomes work ( an area of considerable controversy ) [ 3 - 5 ] . We also looked closely at the requirements for the reporting of economic analyses , which are intended to ensure method ologic transparency and accountability . The Need for Voluntary Guidelines Widespread use of economic analysis as part of the development of pharmaceutical , biotechnologic , and medical devices is relatively new . To date , many economic analyses of health care have focused on pharmaceutical agents , and many such studies have been funded by pharmaceutical companies . Results of these economic outcomes studies are used by medical technology firms to support the pricing and marketing of new interventions and to influence national health care systems and third-party payers in their development of coverage and payment decisions . Managed care organizations , hospitals , and government-subsidized health care programs rely on economic analysis of medical technology to help make formulary purchasing and utilization decisions . Physicians may use the results of these analyses to help guide treatment and prescription decisions . Health care economic outcomes projects are sponsored and conducted by pharmaceutical , biotechnologic , and medical device companies ; government agencies ; nonprofit foundations ; academic investigators ; and private research and consulting firms . The st and ards and methods used to evaluate the safety and efficacy of pharmaceutical products in r and omized , controlled trials have evolved over 50 years of collaboration among research ers in private , public , and academic setting s. Compared with those established to ensure the safety and efficacy of clinical trials , the principles and methods for the conduct of economic studies of health care technology are far less developed . Problems of conduct , reporting , and bias exist in all types of research [ 6 - 14 ] . In response , codes of conduct , such as those developed by the American Federation for Clinical Research and the Institute of Medicine , have been developed for many scientific disciplines [ 15 - 24 ] . These are good models on which to base principles of conduct for economic outcomes analysis . Although many published principles apply to economic studies , others should be modified and new ones should be developed to guide the conduct and reporting of economic outcomes analyses . Economic outcomes research requires unique guidelines for the following reasons : 1 ) As a field , it continues to evolve and is often misunderstood by end users ; 2 ) peer review of it requires special expertise that often exceeds the capabilities of review ers and scientific journals ; 3 ) it often uses secondary data and requires that many assumptions be made [ for example , attribution of a dollar cost to a unit of re source use ] ; 4 ) it offers unique method ologic choices , such as which types of costs to include ( direct , indirect , intangible , induced ) , which perspective to apply ( that of society , payer , provider , patient ) , which design to adopt ( cost- identification , costbenefit , cost-effectiveness , costutility ) , from where to obtain costs [ indemnity data base , managed care or capitated data base , hospital cost systems , Medicare , Medicaid ] , and whether to collect re source consumption data prospect ively or retrospectively through various modeling techniques ; and 5 ) economic studies play an increasingly important role in health care decision making because of increasing financial constraints throughout the health care industry . The financial and medical implication s of decision making done on the basis of these studies , coupled with the lack of widely accepted guidelines about the conduct and reporting of economic analyses , undermine the credibility of this research . A major issue is that the primary source of funding for this research is often the primary financial beneficiary of positive study results . Unfortunately , even valid studies done under the best of circumstances may be suspect [ 25 - 29 ] . This has led at least one major journal to conclude that these analyses should be viewed much like editorials or review articles are viewed in terms of potential for conflicts of interest [ 30 ] . We developed the guidelines reported here after extensive consultation with experts from the public , private , and academic sectors . We recommend that research ers and sponsors adhere to these guidelines , and we suggest they state publicly within their manuscripts that they have done so . End users , including journal editors and readers , consumers , and social decision makers , may then feel more secure in accepting the results of the research , while recognizing that intensive critique of the research will always be necessary . Operations of the Task Force The Task Force on Principles for Economic Analysis of Health Care Technology was initiated and organized by faculty from the Leonard Davis Institute ( LDI ) Center for Health Policy of the University of Pennsylvania . However , because not all LDI faculty were involved , this paper does not represent an official LDI position statement . The Task Force was funded by a coalition of pharmaceutical companies ( Appendix A ) . Funding was also requested ( but not obtained ) from various government and private foundations . All funding was provided in the form of unrestricted research grants or gifts to the University of Pennsylvania . Guidelines derive their credibility in part from the composition of the panel that creates them and the process by which they are developed . C and i date s for participation in the Task Force from the private sector and the academic research community were identified by the frequency with which they were cited in the health economics literature , which was obtained using a MEDLINE search of literature related to economic analyses of medical technology published between 1983 and 1992 . Approximately 15 members attended each meeting . Minutes were distributed after each meeting and approved by all members present . Members from the sponsoring pharmaceutical companies and the academic organizers rotated so that they numbered three and one , respectively , at the table for each formal Task Force meeting . Several professional and governmental organizations , including the Institute of Medicine , the Agency for Health Care Policy and Research , the Food and Drug Administration ( FDA ) , the Health Care Financing Administration , the Centers for Disease Control and Prevention , and a managed care organization , were asked to suggest persons who might participate . In addition , other organizations with a stake in economic analyses were each asked to suggest a person who , because of his or her professional background , had extensive knowledge of or experience with economic analyses . An academic pharmacist , an academic research er , a private research er , an ethicist and patient advocate , and an attorney specializing in medical ethics rounded out the Task Force ( Appendix B ) . Two members withdrew from participation . A small audience consisting of industry sponsors , academic organizers , staff , and a few other interested parties were invited to each meeting and allowed to comment . Four formal meetings of the Task Force were held in Philadelphia during 1993 and 1994 , and the most substantial work was done by various subcommittees between these meetings . The three main subcommittees were titled Ethical Conduct , Responsibility and Control ( the findings of these two subcommittees were later merged into one report ) , and Reporting Requirements for Economic Evaluations ( Appendix C ) . The Task Force was assisted by a professional facilitator . Although Task Force members sought consensus wherever possible on the key issues , consensus was not forced and recommendations were issued only when substantial agreement existed among the members . Task Force members were not asked to formally represent any organization . Formal endorsement of the final document was not sought . Copies of this report will be distributed to all organizations that were asked to suggest a participant and to other parties who responded to announcements placed in The New Engl and Journal of Medicine , Scrip , and the Pink Sheet . The Task Force findings will also be reported at academic conferences , medical profession meetings , and appropriate trade conventions . Findings and Recommendations Valid approaches to economic analyses can be defined ; acceptable methods can be differentiated from unacceptable ones . Bias in economic research stems from two major sources : lack of appropriate independence for
Assured , or " sure thing , " incentives and objective behavioral assessment in particular appear to moderate incentive effectiveness .
The effect estimate from the meta- analysis suggests that financial incentives increase exercise session attendance for interventions up to 6 months in duration .
CONTEXT Less than 5 % of U.S. adults accumulate the required dose of exercise to maintain health .
Behavioral economics has stimulated renewed interest in economic-based , population -level health interventions to address this issue .
Despite widespread implementation of financial incentive-based public health and workplace wellness policies , the effects of financial incentives on exercise initiation and maintenance in adults remain unclear .