BACKGROUND: Pharmacy interventions are a subset of public health interventions and its research is usually performed within the scope of a trial. The economic evaluation of pharmacy interventions requires certain considerations which have some similarities to those of public health interventions and to economic evaluations alongside trials. The objective of this research is to perform an overview of systematic reviews of economic evaluations of pharmacy services and triangulate results with recommendations for economic evaluations of both public health interventions and alongside trials.
METHODS: (1) Exploratory review of recommendations on the economic evaluation of public health interventions, (2) exploratory review of recommendations for conducting economic evaluations alongside trials, (3) overview of systematic reviews of economic evaluations of pharmacy interventions (protocol registered with PROSPERO 2016 outlining information sources, inclusion criteria, appraisal of reviews and synthesis methods).
RESULTS: Fourteen systematic reviews containing 75 index publications were included. Reviews reported favorable economic findings for 71% of studies with full economic evaluations. The types of economic analysis are diverse. Two critical quality domains are absent from most reviews. Key findings include the following: certain types of risk of bias, wider scope of study designs, and most economic quality criteria met but some issues unresolved or unclear. Triangulation revealed additional gaps. Limitations include choice of critical quality domains and potential biases in the overview process.
CONCLUSIONS: Economic evaluations of pharmacy-based public health interventions seem to follow most economic quality criteria, but there are still some issues in certain key areas to improve. These findings may assist in improving the design of pilot trials of economic evaluations in pharmacy, leading to robust evidence for payers. Based on the findings, we propose a methodological approach for the economic evaluation of pharmacy-based public health interventions.
SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016032768.
BACKGROUND: Current interventions to support medication adherence in people with type 2 diabetes are generally resource-intensive and ineffective. Brief messages, such as those delivered via short message service (SMS) systems, are increasingly used in digital health interventions to support adherence because they can be delivered on a wide scale and at low cost. The content of SMS text messages is a crucial intervention feature for promoting behavior change, but it is often unclear what the rationale is for chosen wording or any underlying mechanisms targeted for behavioral change. There is little guidance for developing and optimizing brief message content for use in mobile device-delivered interventions.
OBJECTIVE: This review aimed to (1) identify theoretical constructs (ie, the targets that interventions aim to change) and behavioral strategies (ie, features of intervention content) found to be associated with medication adherence in patients with type 2 diabetes and (2) map these onto a standard taxonomy for behavior change techniques (BCTs, that is, active ingredients of interventions used to promote behavioral change, to produce an evidence-based set of approaches that have shown promise of improving adherence in previous studies and which could be further tested in digital health interventions.
METHODS: A rapid systematic review of existing relevant systematic reviews was conducted. MEDLINE and PsycINFO databases were searched from inception to April 10, 2017. Inclusion criteria were (1) systematic reviews of quantitative data if the studies reviewed identified predictors of or correlates with medication adherence or evaluated medication adherence-enhancing interventions and included adult participants taking medication to manage a chronic physical health condition, and (2) systematic reviews of qualitative studies of experiences of medication adherence for adult participants with type 2 diabetes. Data were extracted on review characteristics and BCTs, theoretical constructs, or behavioral strategies associated with improved adherence. Constructs and strategies were mapped onto the BCT version 1 taxonomy.
RESULTS: A total of 1701 references were identified; 25 systematic reviews (19 quantitative reviews, 3 qualitative reviews, and 3 mixed-method reviews) were included. Moreover, 20 theoretical constructs (eg, self-efficacy) and 19 behavioral strategies (eg, habit analysis) were identified in the included reviews. In total, 46 BCTs were identified as being related to medication adherence in type 2 diabetes (eg, habit formation, prompts or cues, and information about health consequences).
CONCLUSIONS: We identified 46 promising BCTs related to medication adherence in type 2 diabetes on which the content of brief messages delivered through mobile devices to improve adherence could be based. By using explicit systematic review methods and linking our findings to a standardized taxonomy of BCTs, we have described a novel approach for the development of digital message content. Future brief message interventions that aim to support medication adherence could incorporate the identified BCTs.
BACKGROUND: Tobacco use is the leading cause of preventable death in the United States.
PURPOSE: To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation.
DATA SOURCES: 5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic reviews, and PubMed was searched through 1 March 2015 for trials on electronic nicotine delivery systems.
STUDY SELECTION: Two reviewers examined 114 articles to identify English-language reviews that reported health, cessation, or adverse outcomes.
DATA EXTRACTION: One reviewer abstracted data from good- and fair-quality reviews, and a second checked for accuracy.
DATA SYNTHESIS: Fifty-four reviews were included. Behavioral interventions increased smoking cessation at 6 months or more (physician advice had a pooled risk ratio [RR] of 1.76 [95% CI, 1.58 to 1.96]). Nicotine replacement therapy (RR, 1.60 [CI, 1.53 to 1.68]), bupropion (RR, 1.62 [CI, 1.49 to 1.76]), and varenicline (RR, 2.27 [CI, 2.02 to 2.55]) were also effective for smoking cessation. Combined behavioral and pharmacotherapy interventions increased cessation by 82% compared with minimal intervention or usual care (RR, 1.82 [CI, 1.66 to 2.00]). None of the drugs were associated with major cardiovascular adverse events. Only 2 trials addressed efficacy of electronic cigarettes for smoking cessation and found no benefit. Among pregnant women, behavioral interventions benefited cessation and perinatal health; effects of nicotine replacement therapy were not significant.
LIMITATION: Evidence published after each review's last search date was not included.
CONCLUSION: Behavioral and pharmacotherapy interventions improve rates of smoking cessation among the general adult population, alone or in combination. Data on the effectiveness and safety of electronic nicotine delivery systems are limited.
PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
BACKGROUND: Smoking is the leading preventable cause of illness and premature death worldwide. Some medications have been proven to help people to quit, with three licensed for this purpose in Europe and the USA.: nicotine replacement therapy (NRT), bupropion, and varenicline. Cytisine (a treatment pharmacologically similar to varenicline) is also licensed for use in Russia and some of the former socialist economy countries. Other therapies, including nortriptyline, have also been tested for effectiveness.
OBJECTIVES: How do NRT, bupropion and varenicline compare with placebo and with each other in achieving long-term abstinence (six months or longer)?
How do the remaining treatments compare with placebo in achieving long-term abstinence?
How do the risks of adverse and serious adverse events (SAEs) compare between the treatments, and are there instances where the harms may outweigh the benefits?
METHODS: The overview is restricted to Cochrane reviews, all of which include randomised trials. Participants are usually adult smokers, but we exclude reviews of smoking cessation for pregnant women and in particular disease groups or specific settings. We cover nicotine replacement therapy (NRT), antidepressants (bupropion and nortriptyline), nicotine receptor partial agonists (varenicline and cytisine), anxiolytics, selective type 1 cannabinoid receptor antagonists (rimonabant), clonidine, lobeline, dianicline, mecamylamine, Nicobrevin, opioid antagonists, nicotine vaccines, and silver acetate. Our outcome for benefit is continuous or prolonged abstinence at least six months from the start of treatment. Our outcome for harms is the incidence of serious adverse events associated with each of the treatments.
We searched the Cochrane Database of Systematic Reviews (CDSR) in The Cochrane Library, for any reviews with 'smoking' in the title, abstract or keyword fields. The last search was conducted in November 2012. We assessed methodological quality using a revised version of the AMSTAR scale. For NRT, bupropion and varenicline we conducted network meta-analyses, comparing each with the others and with placebo for benefit, and varenicline and bupropion for risks of serious adverse events.
MAIN RESULTS: We identified 12 treatment-specific reviews. The analyses covered 267 studies, involving 101,804 participants. Both NRT and bupropion were superior to placebo (odds ratios (OR) 1.84; 95% credible interval (CredI) 1.71 to 1.99, and 1.82; 95% CredI 1.60 to 2.06 respectively). Varenicline increased the odds of quitting compared with placebo (OR 2.88; 95% CredI 2.40 to 3.47). Head-to-head comparisons between bupropion and NRT showed equal efficacy (OR 0.99; 95% CredI 0.86 to 1.13). Varenicline was superior to single forms of NRT (OR 1.57; 95% CredI 1.29 to 1.91), and to bupropion (OR 1.59; 95% CredI 1.29 to 1.96).
Varenicline was more effective than nicotine patch (OR 1.51; 95% CredI 1.22 to 1.87), than nicotine gum (OR 1.72; 95% CredI 1.38 to 2.13), and than 'other' NRT (inhaler, spray, tablets, lozenges; OR 1.42; 95% CredI 1.12 to 1.79), but was not more effective than combination NRT (OR 1.06; 95% CredI 0.75 to 1.48). Combination NRT also outperformed single formulations. The four categories of NRT performed similarly against each other, apart from 'other' NRT, which was marginally more effective than NRT gum (OR 1.21; 95% CredI 1.01 to 1.46).
Cytisine (a nicotine receptor partial agonist) returned positive findings (risk ratio (RR) 3.98; 95% CI 2.01 to 7.87), without significant adverse events or SAEs.
Across the 82 included and excluded bupropion trials, our estimate of six seizures in the bupropion arms versus none in the placebo arms was lower than the expected rate (1:1000), at about 1:1500. SAE meta-analysis of the bupropion studies demonstrated no excess of neuropsychiatric (RR 0.88; 95% CI 0.31 to 2.50) or cardiovascular events (RR 0.77; 95% CI 0.37 to 1.59). SAE meta-analysis of 14 varenicline trials found no difference between the varenicline and placebo arms (RR 1.06; 95% CI 0.72 to 1.55), and subgroup analyses detected no significant excess of neuropsychiatric events (RR 0.53; 95% CI 0.17 to 1.67), or of cardiac events (RR 1.26; 95% CI 0.62 to 2.56).
Nortriptyline increased the chances of quitting (RR 2.03; 95% CI 1.48 to 2.78). Neither nortriptyline nor bupropion were shown to enhance the effect of NRT compared with NRT alone. Clonidine increased the chances of quitting (RR 1.63; 95% CI 1.22 to 2.18), but this was offset by a dose-dependent rise in adverse events. Mecamylamine in combination with NRT may increase the chances of quitting, but the current evidence is inconclusive. Other treatments failed to demonstrate a benefit compared with placebo. Nicotine vaccines are not yet licensed for use as an aid to smoking cessation or relapse prevention. Nicobrevin's UK license is now revoked, and the manufacturers of rimonabant, taranabant and dianicline are no longer supporting the development or testing of these treatments.
AUTHORS' CONCLUSIONS: NRT, bupropion, varenicline and cytisine have been shown to improve the chances of quitting. Combination NRT and varenicline are equally effective as quitting aids. Nortriptyline also improves the chances of quitting. On current evidence, none of the treatments appear to have an incidence of adverse events that would mitigate their use.
Further research is warranted into the safety of varenicline and into cytisine's potential as an effective and affordable treatment, but not into the efficacy and safety of NRT.
Background: The economic impact and ease of measurement of all-cause hospital readmission rates (HRR) have led to the current debate as to whether they are reducible, and whether they should be used as a publicly reported quality indicators of medical care. Objective: To assess the efficacy of broad clinical interventions in preventing HRR of patients with chronic diseases. Method: A meta-review of published systematic reviews of randomized controlled trials (RCTs) of clinical interventions that have included HRR among the patients' outcomes of interest. Main findings: Meta-analyses of RCTs have consistently found that, in the community, disease management programs significantly reduced HRR in patients with heart failure, coronary heart disease and bronchial asthma, but not in patients with stroke and in unselected patients with chronic disorders. Inhospital interventions, such as discharge planning, pharmacological consultations and multidisciplinary care, and community interventions in patients with chronic obstructive pulmonary diseases had an inconsistent effect on HRR. Main study limitation: Despite their economic impact and ease of measurement, HRR are not the most important outcome of patient care, and efforts aimed at their reduction may compromise patients' health by reducing also justified re-admissions. Conclusions: The efficacy of inhospital interventions in reducing HRR is in need of further study. In patients with heart diseases and bronchial asthma, HRR may be considered as a publicly reported quality indicator of community care, provided that future research confirms that efforts to reduce HRR do not adversely affect other patients' outcomes, such as mortality, functional capacity and quality of life. Future research should also focus on the reasons for the higher efficacy of community interventions in patients with heart diseases and bronchial asthma than in those with other chronic diseases.
To identify the evidence for the effectiveness of behaviour change techniques, when used by health-care professionals, in accomplishing health-promoting behaviours in patients. Reviews were used to extract data at a study level. A taxonomy was used to classify behaviour change techniques. We included 23 systematic reviews: 14 on smoking cessation, 6 on physical exercise, and 2 on healthy diets and 1 on both exercise and diets. None of the behaviour change techniques demonstrated clear effects in a convincing majority of the studies in which they were evaluated. Techniques targeting knowledge (n = 210 studies) and facilitation of behaviour (n = 172) were evaluated most frequently. However, self-monitoring of behaviour (positive effects in 56% of the studies), risk communication (52%) and use of social support (50%) were most often identified as effective. Insufficient insight into appropriateness of technique choice and quality of technique delivery hinder precise conclusions. Relatively, however, self-monitoring of behaviour, risk communication and use of social support are most effective. Health professionals should avoid thinking that providing knowledge, materials and professional support will be sufficient for patients to accomplish change and consider alternative strategies which may be more effective.
BACKGROUND: Several World Health Organisation reports over recent years have highlighted the high incidence of chronic diseases such as diabetes, coronary heart disease and cancer. Contributory factors include unhealthy diets, alcohol and tobacco use and sedentary lifestyles. This paper reports the findings of a review of reviews of behavioural change interventions to reduce unhealthy behaviours or promote healthy behaviours. We included six different health-related behaviours in the review: healthy eating, physical exercise, smoking, alcohol misuse, sexual risk taking (in young people) and illicit drug use. We excluded reviews which focussed on pharmacological treatments or those which required intensive treatments (e.g. for drug or alcohol dependency).
METHODS: The Cochrane Library, Database of Abstracts of Reviews of Effectiveness (DARE) and several Ovid databases were searched for systematic reviews of interventions for the six behaviours (updated search 2008). Two reviewers applied the inclusion criteria, extracted data and assessed the quality of the reviews. The results were discussed in a narrative synthesis.
RESULTS: We included 103 reviews published between 1995 and 2008. The focus of interventions varied, but those targeting specific individuals were generally designed to change an existing behaviour (e.g. cigarette smoking, alcohol misuse), whilst those aimed at the general population or groups such as school children were designed to promote positive behaviours (e.g. healthy eating). Almost 50% (n = 48) of the reviews focussed on smoking (either prevention or cessation). Interventions that were most effective across a range of health behaviours included physician advice or individual counselling, and workplace- and school-based activities. Mass media campaigns and legislative interventions also showed small to moderate effects in changing health behaviours.Generally, the evidence related to short-term effects rather than sustained/longer-term impact and there was a relative lack of evidence on how best to address inequalities.
CONCLUSIONS: Despite limitations of the review of reviews approach, it is encouraging that there are interventions that are effective in achieving behavioural change. Further emphasis in both primary studies and secondary analysis (e.g. systematic reviews) should be placed on assessing the differential effectiveness of interventions across different population subgroups to ensure that health inequalities are addressed.
Pharmacy interventions are a subset of public health interventions and its research is usually performed within the scope of a trial. The economic evaluation of pharmacy interventions requires certain considerations which have some similarities to those of public health interventions and to economic evaluations alongside trials. The objective of this research is to perform an overview of systematic reviews of economic evaluations of pharmacy services and triangulate results with recommendations for economic evaluations of both public health interventions and alongside trials.
METHODS:
(1) Exploratory review of recommendations on the economic evaluation of public health interventions, (2) exploratory review of recommendations for conducting economic evaluations alongside trials, (3) overview of systematic reviews of economic evaluations of pharmacy interventions (protocol registered with PROSPERO 2016 outlining information sources, inclusion criteria, appraisal of reviews and synthesis methods).
RESULTS:
Fourteen systematic reviews containing 75 index publications were included. Reviews reported favorable economic findings for 71% of studies with full economic evaluations. The types of economic analysis are diverse. Two critical quality domains are absent from most reviews. Key findings include the following: certain types of risk of bias, wider scope of study designs, and most economic quality criteria met but some issues unresolved or unclear. Triangulation revealed additional gaps. Limitations include choice of critical quality domains and potential biases in the overview process.
CONCLUSIONS:
Economic evaluations of pharmacy-based public health interventions seem to follow most economic quality criteria, but there are still some issues in certain key areas to improve. These findings may assist in improving the design of pilot trials of economic evaluations in pharmacy, leading to robust evidence for payers. Based on the findings, we propose a methodological approach for the economic evaluation of pharmacy-based public health interventions.
