OBJECTIVE: We conducted this systematic review to support the U.S. Preventive Services Task Force (USPSTF) in updating its 2012 recommendation on screening for and treatment of adult obesity. Our review addressed three key questions: 1) Do primary care–relevant behavioral and/or pharmacotherapy weight loss and weight loss maintenance interventions lead to improved health outcomes among adults who are overweight or have obesity and are a candidate for weight loss interventions? 2) Do primary care–relevant behavioral and/or pharmacotherapy weight loss and weight loss maintenance interventions lead to weight loss, weight loss maintenance, or a reduction in the incidence or prevalence of obesity-related conditions among adults who are overweight or have obesity and are a candidate for weight loss interventions? 3) What are the adverse effects of primary care–relevant behavioral and/or pharmacotherapy weight loss and weight loss maintenance interventions in adults who are overweight or have obesity and are a candidate for weight loss interventions?
DATA SOURCES: We performed a search of MEDLINE, PubMed Publisher-Supplied, PsycINFO, and the Cochrane Central Registry of Controlled Trials for studies published through June 6, 2017. Studies included in the 2011 USPSTF review were re-evaluated for potential inclusion. We supplemented searches by examining reference lists from related articles and expert recommendations and searched federal and international trial registries for ongoing trials. We conducted ongoing surveillance through March 23, 2018 to identify any major studies published in the interim.
STUDY SELECTION: Two researchers reviewed 15,483 titles and abstracts and 572 full-text articles against prespecified inclusion criteria. Eligible studies were those that focused on weight loss in adults who are overweight or have obesity, or maintenance of previous weight loss. Trials among populations selected based on the presence of a chronic disease in which weight loss or maintenance is part of disease management (e.g., known cardiovascular disease, type 2 diabetes) were excluded. Studies included for health and intermediate outcomes (including weight loss) were randomized or clinically controlled trials that report data at least 12 months following the start of the intervention. In addition, for studies of potential harms of interventions we included large cohort, case-control, or event monitoring studies in addition to trials with fewer than 12 months of followup. Included interventions were those conducted in or recruited from primary care or a health care system or were judged to be feasible for implementation or referral from primary care and included behavior-based interventions as well as five U.S. Food and Drug Administration–approved medications for long-term chronic weight management (liraglutide, lorcaserin, naltrexone and bupropion, orlistat, and phentermine-topiramate). Studies of surgical and nonsurgical weight loss devices and procedures were excluded. We conducted dual, independent critical appraisal of all provisionally included studies and abstracted all important study details and results from all studies rated fair or good quality. Data were abstracted by one reviewer and confirmed by another.
DATA ANALYSIS: We synthesized data for behavior- and medication-based weight loss and weight loss maintenance interventions separately. Health outcomes and harms were sparsely reported and the specific outcomes measured differed across trials, precluding meta-analysis, so we summarized those data in tables and narratively. For weight loss outcomes related to behavior-based weight loss interventions, we ran random-effects meta-analyses using the DerSimonian and Laird method to calculate the pooled differences in mean changes (for continuous data) and pooled risk ratio (for binary data). We examined statistical heterogeneity among the pooled studies using standard χ2 tests and estimated the proportion of total variability in point estimates using the I2 statistic. Meta-regression was used to explore potential effect modification by various study, population, and intervention characteristics. We generated funnel plots and conducted tests for small-study effects for all pooled analyses. Meta-analysis of the medication trials was not performed due to the small number of included trials and inconsistency in outcome reporting; therefore, results from these trials were summarized narratively and in illustrative forest plots. Using established methods, we assessed the strength of evidence for each question.
RESULTS: We included 124 studies that were reported in 238 publications. We carried forward 41 studies from our previous review and 83 new studies were added. Of the 124 included studies, 89 trials focused on behavior-based weight loss (80 trials) or weight loss maintenance (nine trials) interventions. Thirty-five studies addressed medications for weight loss (32 studies) or weight loss maintenance (three trials). The majority of trials took place in the United States. Over half (73 trials) represented a general, unselected population of adults who were eligible for participation based on being overweight or having obesity; the remaining trials specifically enrolled participants who were also at elevated clinical or subclinical risk of cardiovascular disease or cancer. The mean baseline body mass index ranged from 25 to 42 kg/m2 and mean age ranged from 22 to 66 years. Eleven trials focused on specific racial/ethnic groups (African American, Asians and South Asians, American Indian, or those of Hispanic ethnicity). In the remaining trials, race/ethnicity and socioeconomic status were not well reported and when described, the majority of participants were white, with medium to high socioeconomic status. The behavior-based interventions were highly variable across the included trials in terms of the modes of delivery, number of sessions and contacts, and interventionists. Across the 120 intervention arms, the primary mode of intervention delivery was: group based (41 arms), individual-based (37 arms), technology-based (22 arms), “mixed” (18 arms), or print only (two arms). Twenty-three interventions included interaction with a primary care provider. The 41 medication-based studies addressed: liraglutide (four trials), lorcaserin (four trials), naltrexone and bupropion (three trials), orlistat (19 trials, two observational studies), and phentermine-topiramate (three trials).HEALTH OUTCOMES: Health outcomes were minimally reported in the behavior-based weight loss and maintenance trials (k=20; n=9910). In four weight loss trials (n=4442) reporting mortality, there were no significant differences between groups over 2 to 16 years. Two weight loss trials (n=2666) reported on cardiovascular events, with neither finding differences between groups over 3 and 10 years, respectively. Health-related quality of life (QOL) was evaluated in 17 weight loss and maintenance trials (n=7120), with almost all showing no differences between groups. Trials of medication-based weight loss interventions examined few health outcomes beyond QOL (k=10; n=13,145). Although most studies showed evidence of a greater improvement in obesity-specific QOL among those on medication compared with placebo, the differences were small and of unclear clinical significance. In addition, interpretation of these finding was limited given high study dropout rates (≥35% in half the included trials). Two medication-based trials (n=6210) examined cardiovascular events, finding few events in any group. None of the medication-based maintenance trials reported the effects of the interventions on health outcomes. WEIGHT OUTCOMES: Pooled results of 67 behavior-based weight loss trials indicated greater weight loss from interventions compared to control conditions at 12 to 18 months (mean difference in weight change [MD], −2.39 kg [−5.3 lb] [95% CI, −2.86 to −1.93]; k=67; n=22,065; I2=90.0%). Mean absolute changes in weight ranged from −0.5 kg (−1.1 lb) to −9.3 kg (−20.5 lb) among intervention participants and from 1.4 kg (3.0 lb) to −5.6 (−12.3 lb) among control participants. Weight change at followup beyond 12 to 18 months was not as well reported but effects were consistent with short-term weight loss, although generally attenuated, over time. A meta-analysis of 38 trials found that intervention participants had a 1.94 times greater probability of losing 5 percent of their initial weight compared with control groups over 12 to 18 months (risk ratio [RR], 1.94 [95% CI, 1.70 to 2.22]; k=38; n=12,231; I2=67.2%), which translated into a number needed to treat of 8. Among the majority of trials of behavior-based weight loss maintenance interventions, both intervention and control participants regained weight over 12 to 18 months of maintenance; however, the intervention participants experienced less weight regain (pooled MD, −1.59 kg [−3.5 lb] [95% CI, −2.38 to −0.79]; k=8; n=1408; I2=26.8%). Among 32 medication-based weight loss trials, those randomized to medications experienced greater weight loss compared to those on placebo at 12 to 18 months (mean/least squares mean [LSM] MD ranged from −1.0 kg [−2.2 lb] to −5.8 kg [−12.8 lb]; no meta-analysis conducted). Absolute changes in weight ranged from mean/LSM of −3.3 kg (−7.3 lb) to −10.5 kg (−23.4 lb) among medication participants compared to −0.9 kg (−2.0 lb) to −7.6 kg (−16.8 lb) among placebo participants over 12 to 18 months. Medication participants had a 1.2 to 3.9 times greater probability of losing 5 percent of their initial weight compared with placebo participants over 12 to 18 months. Three medication-based trials indicate greater weight maintenance in medication than placebo participants over 12 to 36 months (MD ranged from −0.6 to −3.5; no meta-analysis conducted). INTERMEDIATE OUTCOMES: Thirteen trials (n=4095) examined incident diabetes among those in behavior-based interventions compared to control conditions. Absolute cumulative incidence of diabetes at up to 3 years of followup ranged from 0 to 15 percent in the intervention group and 0 to 29 percent in controls. The DPP and Finnish DPS trials found statistically significant lower incidences of developing diabetes at 3 to 9 years; no other trial found differences between groups. However, these trials generally had smaller sample sizes and shorter followup. The pooled relative risk of developing incident diabetes was 0.67 (95% CI, 0.51 to 0.89; k=9; n=3140; I2=49.2%). Four trials of weight loss medications (three weight loss and one maintenance trial) examined incident diabetes. Absolute cumulative incidence of diabetes at up to 4 years of followup ranged from 0 to 6 percent in medication arms and 1 to 11 percent in placebo arms; between-group differences were statistically different in most medication trials. Prevalence of hypertension, metabolic syndrome, use of CVD medications, and estimated 10-year risk of CVD were sparsely reported. There was limited evidence from larger trials that those in behavior-based weight loss arms had reduced prevalence of hypertension and use of CVD medications compared to control conditions; data were limited and mixed for metabolic syndrome and 10-year CVD risk. Four medication trials reported on use of lipid-lowering and antihypertensive medications, prevalence of metabolic syndrome, and 10-year CVD risk score with mixed results. ADVERSE EVENTS: There were no serious harms related to the behavior-based interventions and most trials noted no differences between groups in the rates of adverse events, including cardiovascular events. In the three behavior-based trials large enough to examine musculoskeletal issues between groups, results were mixed. Although serious adverse events were relatively uncommon in medication trials and generally similar between groups, adverse event rates were high in both groups by 12 months, with 80 to 96 percent experiencing an adverse event in the medication arms compared with 63 to 94 percent in the placebo arms. The higher rates of adverse events in the medication arms resulted in higher dropout rates than in the placebo arms.
CONCLUSION: We found that behavior-based weight-loss interventions with or without weight loss medications resulted in more weight loss than usual care conditions. The degree of weight loss we observed with the behavior-based weight loss interventions in the current review is slightly smaller but consistent in magnitude with our 2011 review on this topic. As in the previous review, we noted that weight loss interventions resulted in a decreased risk of developing diabetes, particularly among those with prediabetes, although the prevalence of other intermediate health outcomes was less well reported. Limited evidence exists regarding health outcomes associated with weight loss interventions. Weight loss medications, but not behavior-based interventions, were associated with higher rates of harms compared with control arms. Heterogeneity within each individual intervention arm confounded with differences in the populations, settings, and trial quality, making it difficult to disentangle which variables may be driving larger effects. Long-term weight and health outcomes data, as well as data on important subgroups (e.g. those who are older, nonwhite, or overweight) were lacking and should be a high priority for future study.
Motivation is an integral factor in substance use treatment and long-term recovery. However, it is unclear what role intrinsic and extrinsic motivation play across different treatment modalities. A meta-analysis (N = 84) was performed to estimate the pooled effect size of Motivational Interviewing (MI; primarily targeting intrinsic motivation) and contingency management (CM; primarily targeting extrinsic motivation) at different follow-up periods. Collapsed across all substance types, CM had a significant effect at 3-month follow-up, only. In contrast, MI had a significant effect at 6-month follow-up, only. CM had small and medium effects on multiple substances at 3-month follow-up (i.e., tobacco, marijuana, stimulants, polysubstances), but not at 6-month follow-up. MI had 1 significant medium effect at 3-month follow-up (i.e., marijuana), but several significant small effects at 6-month follow-up (i.e., alcohol, tobacco, polysubstances). This meta-analysis suggests that both CM and MI promote reductions in a range of substances, even several months after the intervention concludes. Further, these results provide some evidence that extrinsically focused CM may produce medium follow-up effects in the short run, but intrinsically focused MI may produce small but durable follow-up effects. However, this interpretation is complicated by the differences between the MI and CM studies that preclude statistical tests comparing effect sizes, and few studies assessed motivation itself. Future researchers should investigate how motivational dynamics impact lasting outcomes in substance use treatment. (PsycINFO Database Record (c) 2017 APA, all rights reserved)
CONTEXT: Population-level coverage for immunization against many vaccine-preventable diseases remains below optimal rates in the U.S. The Community Preventive Services Task Force recently recommended several interventions to increase vaccination coverage based on systematic reviews of the evaluation literature. The present study provides the economic results from those reviews.
EVIDENCE ACQUISITION: A systematic review was conducted (search period, January 1980 through February 2012) to identify economic evaluations of 12 interventions recommended by the Task Force. Evidence was drawn from included studies; estimates were constructed for the population reach of each strategy, cost of implementation, and cost per additional vaccinated person because of the intervention. Analyses were conducted in 2014.
EVIDENCE SYNTHESIS: Reminder systems, whether for clients or providers, were among the lowest-cost strategies to implement and the most cost effective in terms of additional people vaccinated. Strategies involving home visits and combination strategies in community settings were both costly and less cost effective. Strategies based in settings such as schools and MCOs that reached the target population achieved additional vaccinations in the middle range of cost effectiveness.
CONCLUSIONS: The interventions recommended by the Task Force differed in reach, cost, and cost effectiveness. This systematic review presents the economic information for 12 effective strategies to increase vaccination coverage that can guide implementers in their choice of interventions to fit their local needs, available resources, and budget.
Vaccination is one of the most effective ways of reducing childhood mortality. Despite global uptake of childhood vaccinations increasing, rates remain sub-optimal, meaning that vaccine-preventable diseases still pose a public health risk. A range of interventions to promote vaccine uptake have been developed, although this range has not specifically been reviewed in early childhood. We conducted a systematic review and meta-analysis of parental interventions to improve early childhood (0-5 years) vaccine uptake. Twenty-eight controlled studies contributed to six separate meta-analyses evaluating aspects of parental reminders and education. All interventions were to some extent effective, although findings were generally heterogeneous and random effects models were estimated. Receiving both postal and telephone reminders was the most effective reminder-based intervention (RD=0.1132; 95% CI=0.033-0.193). Sub-group analyses suggested that educational interventions were more effective in low- and middle-income countries (RD=0.13; 95% CI=0.05-0.22) and when conducted through discussion (RD=0.12; 95% CI=0.02-0.21). Current evidence most supports the use of postal reminders as part of the standard management of childhood immunisations. Parents at high risk of non-compliance may benefit from recall strategies and/or discussion-based forums, however further research is needed to assess the appropriateness of these strategies.
BACKGROUND: Patient adherence to medications, particularly for conditions requiring prolonged treatment such as tuberculosis (TB), is frequently less than ideal and can result in poor treatment outcomes. Material incentives to reward good behaviour and enablers to remove economic barriers to accessing care are sometimes given in the form of cash, vouchers, or food to improve adherence.
OBJECTIVES: To evaluate the effects of material incentives and enablers in patients undergoing diagnostic testing, or receiving prophylactic or curative therapy, for TB.
SEARCH METHODS: We undertook a comprehensive search of the Cochrane Infectious Diseases Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; LILACS; Science Citation Index; and reference lists of relevant publications up to 5 June 2015.
SELECTION CRITERIA: Randomized controlled trials of material incentives in patients being investigated for TB, or on treatment for latent or active TB.
DATA COLLECTION AND ANALYSIS: At least two review authors independently screened and selected studies, extracted data, and assessed the risk of bias in the included trials. We compared the effects of interventions using risk ratios (RR), and presented RRs with 95% confidence intervals (CI). The quality of the evidence was assessed using GRADE.
MAIN RESULTS: We identified 12 eligible trials. Ten were conducted in the USA.: in adolescents (one trial), in injection drug or cocaine users (four trials), in homeless adults (three trials), and in prisoners (two trials). The remaining two trials, in general adult populations, were conducted in Timor-Leste and South Africa. Sustained incentive programmesOnly two trials have assessed whether material incentives and enablers can improve long-term adherence and completion of treatment for active TB, and neither demonstrated a clear benefit (RR 1.04, 95% CI 0.97 to 1.14; two trials, 4356 participants; low quality evidence). In one trial, the incentive, given as a daily hot meal, was not well received by the population due to the inconvenience of attending the clinic at midday, whilst in the other trial, nurses distributing the vouchers chose to "ration" their distribution among eligible patients, giving only to those whom they felt were most deprived.Three trials assessed the effects of material incentives and enablers on completion of TB prophylaxis with mixed results (low quality evidence). A large effect was seen with regular cash incentives given to drug users at each clinic visit in a setting with extremely low treatment completion in the control group (treatment completion 52.8% intervention versus 3.6% control; RR 14.53, 95% CI 3.64 to 57.98; one trial, 108 participants), but no effects were seen in one trial assessing a one-off cash incentive for recently released prisoners (373 participants), or another trial assessing material incentives offered by parents to teenagers (388 participants). Single once-only incentivesHowever in specific populations, such as recently released prisoners, drug users, and the homeless, trials show that material incentives probably do improve one-off clinic re-attendance for initiation or continuation of anti-TB prophylaxis (RR 1.58, 95% CI 1.27 to 1.96; three trials, 595 participants; moderate quality evidence), and may increase the return rate for reading of tuberculin skin test results (RR 2.16, 95% CI 1.41 to 3.29; two trials, 1371 participants; low quality evidence). Comparison of different types of incentivesSingle trials in specific sub-populations suggest that an immediate cash incentive may be more effective than delaying the incentive until completion of treatment (RR 1.11, 95% CI 0.98 to 1.24; one trial, 300 participants; low quality evidence), cash incentives may be more effective than non-cash incentives (completion of TB prophylaxis: RR 1.26, 95% CI 1.02 to 1.56; one trial, 141 participants; low quality evidence; return for skin test reading: RR 1.13, 95% CI 1.07 to 1.19; one trial, 652 participants; low quality evidence); and higher cash incentives may be more effective than lower cash incentives (RR 1.08, 95% CI 1.01 to 1.16; one trial, 404 participants; low quality evidence).
AUTHORS' CONCLUSIONS: Material incentives and enablers may have some positive short term effects on clinic attendance, particularly for marginal populations such as drug users, recently released prisoners, and the homeless, but there is currently insufficient evidence to know if they can improve long term adherence to TB treatment.
BACKGROUND: Prenatal care is recommended during pregnancy as a method to improve neonatal and maternal outcomes. Improving the use of prenatal care is important, particularly for women at moderate to high risk of adverse outcomes. Incentives are sometimes utilized to encourage women to attend prenatal care visits.
OBJECTIVES: To determine whether incentives are an effective tool to increase utilization of timely prenatal care among women.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 January 2015) and the reference lists of all retrieved studies.
SELECTION CRITERIA: Randomized controlled trials (RCTs), quasi-RCTs, and cluster-RCTs that utilized direct incentives to pregnant women explicitly linked to initiation and frequency of prenatal care were included. Incentives could include cash, vouchers, coupons or products not generally offered to women as a standard of prenatal care. Comparisons were to no incentives and to incentives not linked directly to utilization of care. We also planned to compare different types of interventions, i.e. monetary versus products or services.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and methodological quality. Two review authors independently extracted data. Data were checked for accuracy.
MAIN RESULTS: We identified 11 studies (19 reports), six of which we excluded. Five studies, involving 11,935 pregnancies were included, but only 1893 pregnancies contributed data regarding our specified outcomes. Incentives in the studies included cash, gift card, baby carrier, baby blanket or taxicab voucher and were compared with no incentives. Meta-analysis was performed for only one outcome 'Return for postpartum care' and this outcome was not pre-specified in our protocol. Other analyses were restricted to data from single studies.Trials were at a moderate risk of bias overall. Randomization and allocation were adequate and risk of selection bias was low in three studies and unclear in two studies. None of the studies were blinded to the participants. Blinding of outcome assessors was adequate in one study, but was limited or not described in the remaining four studies. Risk of attrition was deemed to be low in all studies that contributed data to the review. Two of the studies reported or analyzed data in a manner that was not consistent with the predetermined protocol and thus were deemed to be at high risk. The other three studies were low risk for reporting bias. The largest two of the five studies comprising the majority of participants took place in rural, low-income, homogenously Hispanic communities in Central America. This setting introduces a number of confounding factors that may affect generalizability of these findings to ethnically and economically diverse urban communities in developed countries.The five included studies of incentive programs did not report any of this review's primary outcomes: preterm birth, small-for-gestational age, or perinatal death.In terms of this review's secondary outcomes, pregnant women receiving incentives were no more likely to initiate prenatal care (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.78 to 1.38, one study, 104 pregnancies). Pregnant women receiving incentives were more likely to attend prenatal visits on a frequent basis (RR 1.18, 95% CI 1.01 to 1.38, one study, 606 pregnancies) and obtain adequate prenatal care defined by number of “procedures” such as testing blood sugar or blood pressure, vaccinations and counseling about breastfeeding and birth control (mean difference (MD) 5.84, 95% CI 1.88 to 9.80, one study, 892 pregnancies). In contrast, women who received incentives were more likely to deliver by cesarean section (RR 1.97, 95% CI 1.18 to 3.30, one study, 979 pregnancies) compared to those women who did not receive incentives.Women who received incentives were no more likely to return for postpartum care based on results of meta-analysis (average RR 0.75, 95% CI 0.21 to 2.64, two studies, 833 pregnancies, Tau² = 0.81, I² = 98%). However, there was substantial heterogeneity in this analysis so a subgroup analysis was performed and this identified a clear difference between subgroups based on the type of incentive being offered. In one study, women receiving non-cash incentives were more likely to return for postpartum care (RR 1.26, 95% CI 1.09 to 1.47, 240 pregnancies) than women who did not receive non-cash incentives. In another study, women receiving cash incentives were less likely to return for postpartum care (RR 0.43, 95% CI 0.30 to 0.62, 593 pregnancies) than women who did not receive cash incentives.No data were identified for the following secondary outcomes: frequency of prenatal care; pre-eclampsia; satisfaction with birth experience; maternal mortality; low birthweight (less than 2500 g); infant macrosomia (birthweight greater than 4000 g); or five-minute Apgar less than seven.
AUTHORS' CONCLUSIONS: The included studies did not report on this review's main outcomes: preterm birth, small-for-gestational age, or perinatal death. There is limited evidence that incentives may increase utilization and quality of prenatal care, but may also increase cesarean rate. Overall, there is insufficient evidence to fully evaluate the impact of incentives on prenatal care initiation. There are conflicting data as to the impact of incentives on return for postpartum care. Two of the five studies which accounted for the majority of women in this review were conducted in rural, low-income, overwhelmingly Hispanic communities in Central America, thus limiting the external validity of these results.There is a need for high-quality RCTs to determine whether incentive program increase prenatal care use and improve maternal and neonatal outcomes. Incentive programs, in particular cash-based programs, as suggested in this review and in several observational studies may improve the frequency and ensure adequate quality of prenatal care. No peer-reviewed data have been made publicly available for one of the largest incentive-based prenatal programs – the statewide Medicaid-based programs within the United States. These observational data represent an important starting point for future research with significant implications for policy development and allocation of healthcare resources. The disparate findings related to attending postpartum care should also be further explored as the findings were limited by the number of studies. Future large RCTs are needed to focus on the outcomes of preterm birth, small-for-gestational age and perinatal outcomes.
OBJECTIVES: Uncertainty remains about whether personal financial incentives could achieve sustained changes in health-related behaviors that would reduce the fast-growing global non-communicable disease burden. This review aims to estimate whether: i. financial incentives achieve sustained changes in smoking, eating, alcohol consumption and physical activity; ii. effectiveness is modified by (a) the target behavior, (b) incentive value and attainment certainty, (c) recipients' deprivation level.
METHODS: Multiple sources were searched for trials offering adults financial incentives and assessing outcomes relating to pre-specified behaviors at a minimum of six months from baseline. Analyses included random-effects meta-analyses and meta-regressions grouped by timed endpoints.
RESULTS: Of 24,265 unique identified articles, 34 were included in the analysis. Financial incentives increased behavior-change, with effects sustained until 18months from baseline (OR: 1.53, 95% CI 1.05-2.23) and three months post-incentive removal (OR: 2.11, 95% CI 1.21-3.67). High deprivation increased incentive effects (OR: 2.17; 95% CI 1.22-3.85), but only at >6-12months from baseline. Other assessed variables did not independently modify effects at any time-point.
CONCLUSIONS: Personal financial incentives can change habitual health-related behaviors and help reduce health inequalities. However, their role in reducing disease burden is potentially limited given current evidence that effects dissipate beyond three months post-incentive removal.
BACKGROUND AND OBJECTIVE: Financial incentives have been used to promote vaccination uptake but are not always viewed as acceptable. Quasimandatory policies, such as requiring vaccinations for school enrollment, are widely implemented in some countries. A systematic review was conducted to determine the effectiveness, acceptability, and economic costs and consequences of parental financial incentives and quasimandatory schemes for increasing the uptake of preschool vaccinations in high-income countries.
METHODS: Electronic databases and gray literature were searched for randomized controlled trials, controlled before-and-after studies, and time series analyses examining the effectiveness of parental financial incentives and quasimandatory schemes, as well as any empirical studies exploring acceptability. All included studies were screened for information on economic costs and consequences. Two reviewers independently assessed studies for inclusion, extracted data, and assessed the quality of selected articles by using established instruments. Studies were synthesized in narrative reviews.
RESULTS: Four studies on the effectiveness and 6 on the acceptability of parental financial incentives and quasimandatory interventions met the inclusion criteria. Only 1 study reported on costs and consequences. Studies of effectiveness had low risk of bias but displayed substantial heterogeneity in terms of interventions and methods.
CONCLUSIONS: There was insufficient evidence to conclude whether these interventions were effective. Studies of acceptability suggested a preference, in settings where this already occurs, for incentives linking vaccinations to access to education. There was insufficient evidence to draw conclusions on economic costs and consequences.
OBJECTIVES: To conduct a systematic review of strategies to optimize immunisation uptake within preschool children in developed countries.
DESIGN: Systematic review.
SETTING: Developed countries
PARTICIPANTS: Preschool children who were due, or overdue, one or more of their routine primary immunisations.
MAIN OUTCOME MEASURES: Increase in the proportion of the target population up to date with standard recommended universal vaccinations.
RESULTS: Forty-six studies were included for analysis, published between 1980 and 2009. Twenty-six studies were randomized controlled trials, 11 were before and after trials, and nine were controlled intervention trials. Parental reminders showed a statistically significant increase in immunisation rates in 34% of included intervention arms. These effects were reported with both generic and specific reminders and with all methods of reminders and recall. Strategies aimed at immunisation providers were also shown to improve immunisation rates with a median change in immunisation rates of 7% when reminders were used, 8% when educational programmes were used and 19% when feedback programmes were used.
CONCLUSION: General practitioners are uniquely positioned to influence parental decisions on childhood immunisation. A variety of strategies studied in primary care settings have been shown to improve immunisation rates, including parental and healthcare provider reminders.
OBJECTIVES:: We conducted a systematic review on outcomes and costs of community health worker (CHW) interventions. CHWs are increasingly expected to improve health outcomes cost-effectively for the underserved. RESEARCH DESIGN:: We searched Medline, Cochrane Collaboration resources, and the Cumulative Index to Nursing and Allied Health Literature for studies conducted in the United States and published in English from 1980 through November 2008. We dually reviewed abstracts, full-text articles, data abstractions, quality ratings, and strength of evidence grades and resolved disagreements by consensus. RESULTS:: We included 53 studies on outcomes of CHW interventions and 6 on cost or cost-effectiveness. For outcomes, limited evidence (5 studies) suggests that CHW interventions can improve participant knowledge compared with alternative approaches or no intervention. We found mixed evidence for participant behavior change (22 studies) and health outcomes (27 studies). Some studies suggested that CHW interventions can result in greater improvements in participant behavior and health outcomes compared with various alternatives, but other studies suggested that CHW interventions provide no statistically different benefits than alternatives. We found low or moderate strength of evidence suggesting that CHWs can increase appropriate health care utilization for some interventions (30 studies). Six studies with economic information yielded insufficient data to evaluate the cost-effectiveness of CHW interventions relative to other interventions. CONCLUSIONS:: CHWs can improve outcomes for underserved populations for some health conditions. The effectiveness of CHWs in many health care areas requires further research that addresses the methodologic limitations of prior studies and that contributes to translating research into practice.
We conducted this systematic review to support the U.S. Preventive Services Task Force (USPSTF) in updating its 2012 recommendation on screening for and treatment of adult obesity. Our review addressed three key questions: 1) Do primary care–relevant behavioral and/or pharmacotherapy weight loss and weight loss maintenance interventions lead to improved health outcomes among adults who are overweight or have obesity and are a candidate for weight loss interventions? 2) Do primary care–relevant behavioral and/or pharmacotherapy weight loss and weight loss maintenance interventions lead to weight loss, weight loss maintenance, or a reduction in the incidence or prevalence of obesity-related conditions among adults who are overweight or have obesity and are a candidate for weight loss interventions? 3) What are the adverse effects of primary care–relevant behavioral and/or pharmacotherapy weight loss and weight loss maintenance interventions in adults who are overweight or have obesity and are a candidate for weight loss interventions?
DATA SOURCES:
We performed a search of MEDLINE, PubMed Publisher-Supplied, PsycINFO, and the Cochrane Central Registry of Controlled Trials for studies published through June 6, 2017. Studies included in the 2011 USPSTF review were re-evaluated for potential inclusion. We supplemented searches by examining reference lists from related articles and expert recommendations and searched federal and international trial registries for ongoing trials. We conducted ongoing surveillance through March 23, 2018 to identify any major studies published in the interim.
STUDY SELECTION:
Two researchers reviewed 15,483 titles and abstracts and 572 full-text articles against prespecified inclusion criteria. Eligible studies were those that focused on weight loss in adults who are overweight or have obesity, or maintenance of previous weight loss. Trials among populations selected based on the presence of a chronic disease in which weight loss or maintenance is part of disease management (e.g., known cardiovascular disease, type 2 diabetes) were excluded. Studies included for health and intermediate outcomes (including weight loss) were randomized or clinically controlled trials that report data at least 12 months following the start of the intervention. In addition, for studies of potential harms of interventions we included large cohort, case-control, or event monitoring studies in addition to trials with fewer than 12 months of followup. Included interventions were those conducted in or recruited from primary care or a health care system or were judged to be feasible for implementation or referral from primary care and included behavior-based interventions as well as five U.S. Food and Drug Administration–approved medications for long-term chronic weight management (liraglutide, lorcaserin, naltrexone and bupropion, orlistat, and phentermine-topiramate). Studies of surgical and nonsurgical weight loss devices and procedures were excluded. We conducted dual, independent critical appraisal of all provisionally included studies and abstracted all important study details and results from all studies rated fair or good quality. Data were abstracted by one reviewer and confirmed by another.
DATA ANALYSIS:
We synthesized data for behavior- and medication-based weight loss and weight loss maintenance interventions separately. Health outcomes and harms were sparsely reported and the specific outcomes measured differed across trials, precluding meta-analysis, so we summarized those data in tables and narratively. For weight loss outcomes related to behavior-based weight loss interventions, we ran random-effects meta-analyses using the DerSimonian and Laird method to calculate the pooled differences in mean changes (for continuous data) and pooled risk ratio (for binary data). We examined statistical heterogeneity among the pooled studies using standard χ2 tests and estimated the proportion of total variability in point estimates using the I2 statistic. Meta-regression was used to explore potential effect modification by various study, population, and intervention characteristics. We generated funnel plots and conducted tests for small-study effects for all pooled analyses. Meta-analysis of the medication trials was not performed due to the small number of included trials and inconsistency in outcome reporting; therefore, results from these trials were summarized narratively and in illustrative forest plots. Using established methods, we assessed the strength of evidence for each question.
RESULTS:
We included 124 studies that were reported in 238 publications. We carried forward 41 studies from our previous review and 83 new studies were added. Of the 124 included studies, 89 trials focused on behavior-based weight loss (80 trials) or weight loss maintenance (nine trials) interventions. Thirty-five studies addressed medications for weight loss (32 studies) or weight loss maintenance (three trials). The majority of trials took place in the United States. Over half (73 trials) represented a general, unselected population of adults who were eligible for participation based on being overweight or having obesity; the remaining trials specifically enrolled participants who were also at elevated clinical or subclinical risk of cardiovascular disease or cancer. The mean baseline body mass index ranged from 25 to 42 kg/m2 and mean age ranged from 22 to 66 years. Eleven trials focused on specific racial/ethnic groups (African American, Asians and South Asians, American Indian, or those of Hispanic ethnicity). In the remaining trials, race/ethnicity and socioeconomic status were not well reported and when described, the majority of participants were white, with medium to high socioeconomic status. The behavior-based interventions were highly variable across the included trials in terms of the modes of delivery, number of sessions and contacts, and interventionists. Across the 120 intervention arms, the primary mode of intervention delivery was: group based (41 arms), individual-based (37 arms), technology-based (22 arms), “mixed” (18 arms), or print only (two arms). Twenty-three interventions included interaction with a primary care provider. The 41 medication-based studies addressed: liraglutide (four trials), lorcaserin (four trials), naltrexone and bupropion (three trials), orlistat (19 trials, two observational studies), and phentermine-topiramate (three trials).
HEALTH OUTCOMES:
Health outcomes were minimally reported in the behavior-based weight loss and maintenance trials (k=20; n=9910). In four weight loss trials (n=4442) reporting mortality, there were no significant differences between groups over 2 to 16 years. Two weight loss trials (n=2666) reported on cardiovascular events, with neither finding differences between groups over 3 and 10 years, respectively. Health-related quality of life (QOL) was evaluated in 17 weight loss and maintenance trials (n=7120), with almost all showing no differences between groups. Trials of medication-based weight loss interventions examined few health outcomes beyond QOL (k=10; n=13,145). Although most studies showed evidence of a greater improvement in obesity-specific QOL among those on medication compared with placebo, the differences were small and of unclear clinical significance. In addition, interpretation of these finding was limited given high study dropout rates (≥35% in half the included trials). Two medication-based trials (n=6210) examined cardiovascular events, finding few events in any group. None of the medication-based maintenance trials reported the effects of the interventions on health outcomes.
WEIGHT OUTCOMES:
Pooled results of 67 behavior-based weight loss trials indicated greater weight loss from interventions compared to control conditions at 12 to 18 months (mean difference in weight change [MD], −2.39 kg [−5.3 lb] [95% CI, −2.86 to −1.93]; k=67; n=22,065; I2=90.0%). Mean absolute changes in weight ranged from −0.5 kg (−1.1 lb) to −9.3 kg (−20.5 lb) among intervention participants and from 1.4 kg (3.0 lb) to −5.6 (−12.3 lb) among control participants. Weight change at followup beyond 12 to 18 months was not as well reported but effects were consistent with short-term weight loss, although generally attenuated, over time. A meta-analysis of 38 trials found that intervention participants had a 1.94 times greater probability of losing 5 percent of their initial weight compared with control groups over 12 to 18 months (risk ratio [RR], 1.94 [95% CI, 1.70 to 2.22]; k=38; n=12,231; I2=67.2%), which translated into a number needed to treat of 8. Among the majority of trials of behavior-based weight loss maintenance interventions, both intervention and control participants regained weight over 12 to 18 months of maintenance; however, the intervention participants experienced less weight regain (pooled MD, −1.59 kg [−3.5 lb] [95% CI, −2.38 to −0.79]; k=8; n=1408; I2=26.8%). Among 32 medication-based weight loss trials, those randomized to medications experienced greater weight loss compared to those on placebo at 12 to 18 months (mean/least squares mean [LSM] MD ranged from −1.0 kg [−2.2 lb] to −5.8 kg [−12.8 lb]; no meta-analysis conducted). Absolute changes in weight ranged from mean/LSM of −3.3 kg (−7.3 lb) to −10.5 kg (−23.4 lb) among medication participants compared to −0.9 kg (−2.0 lb) to −7.6 kg (−16.8 lb) among placebo participants over 12 to 18 months. Medication participants had a 1.2 to 3.9 times greater probability of losing 5 percent of their initial weight compared with placebo participants over 12 to 18 months. Three medication-based trials indicate greater weight maintenance in medication than placebo participants over 12 to 36 months (MD ranged from −0.6 to −3.5; no meta-analysis conducted).
INTERMEDIATE OUTCOMES:
Thirteen trials (n=4095) examined incident diabetes among those in behavior-based interventions compared to control conditions. Absolute cumulative incidence of diabetes at up to 3 years of followup ranged from 0 to 15 percent in the intervention group and 0 to 29 percent in controls. The DPP and Finnish DPS trials found statistically significant lower incidences of developing diabetes at 3 to 9 years; no other trial found differences between groups. However, these trials generally had smaller sample sizes and shorter followup. The pooled relative risk of developing incident diabetes was 0.67 (95% CI, 0.51 to 0.89; k=9; n=3140; I2=49.2%). Four trials of weight loss medications (three weight loss and one maintenance trial) examined incident diabetes. Absolute cumulative incidence of diabetes at up to 4 years of followup ranged from 0 to 6 percent in medication arms and 1 to 11 percent in placebo arms; between-group differences were statistically different in most medication trials. Prevalence of hypertension, metabolic syndrome, use of CVD medications, and estimated 10-year risk of CVD were sparsely reported. There was limited evidence from larger trials that those in behavior-based weight loss arms had reduced prevalence of hypertension and use of CVD medications compared to control conditions; data were limited and mixed for metabolic syndrome and 10-year CVD risk. Four medication trials reported on use of lipid-lowering and antihypertensive medications, prevalence of metabolic syndrome, and 10-year CVD risk score with mixed results.
ADVERSE EVENTS:
There were no serious harms related to the behavior-based interventions and most trials noted no differences between groups in the rates of adverse events, including cardiovascular events. In the three behavior-based trials large enough to examine musculoskeletal issues between groups, results were mixed. Although serious adverse events were relatively uncommon in medication trials and generally similar between groups, adverse event rates were high in both groups by 12 months, with 80 to 96 percent experiencing an adverse event in the medication arms compared with 63 to 94 percent in the placebo arms. The higher rates of adverse events in the medication arms resulted in higher dropout rates than in the placebo arms.
CONCLUSION:
We found that behavior-based weight-loss interventions with or without weight loss medications resulted in more weight loss than usual care conditions. The degree of weight loss we observed with the behavior-based weight loss interventions in the current review is slightly smaller but consistent in magnitude with our 2011 review on this topic. As in the previous review, we noted that weight loss interventions resulted in a decreased risk of developing diabetes, particularly among those with prediabetes, although the prevalence of other intermediate health outcomes was less well reported. Limited evidence exists regarding health outcomes associated with weight loss interventions. Weight loss medications, but not behavior-based interventions, were associated with higher rates of harms compared with control arms. Heterogeneity within each individual intervention arm confounded with differences in the populations, settings, and trial quality, making it difficult to disentangle which variables may be driving larger effects. Long-term weight and health outcomes data, as well as data on important subgroups (e.g. those who are older, nonwhite, or overweight) were lacking and should be a high priority for future study.
