Community pharmacy interventions for public health priorities: a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions

Article history

The research reported in this issue of the journal was funded by the PHR programme as project number 12/153/52. The contractual start date was in March 2014. The final report began editorial review in March 2015 and was accepted for publication in July 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

none

Copyright statement

© Queen’s Printer and Controller of HMSO 2016. This work was produced by Brown et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Policy context

A number of agencies and countries, including the World Health Organization (WHO) and the Department of Health (DH) for England, have set a clear agenda for the future of public health. This agenda is focused on improving the healthy life expectancy of the population and, where possible, reducing or removing threats to this aim. 1,2 One strand within this agenda is to create accessible, multidisciplinary networks of public health professionals who work within communities and provide services to address key public health issues, health inequalities, and ultimately improve health and well-being. Worldwide, community pharmacies may be an important component of this agenda; WHO acknowledges that community pharmacies and their staff are easily accessible and, as such, could play a key role in public health initiatives. Interventions that aim to reduce obesity, smoking rates and alcohol misuse, led by community pharmacists and other service providers, have been identified by the DH as public health priorities. 3,4 Indeed, it is thought that the key characteristic through which community pharmacy-based public health interventions may have a positive impact on health equity relates to their access and acceptability.

Excessive alcohol intake, smoking and obesity are three of the most significant modifiable risk factors for morbidity and mortality in middle- and high-income countries. 5,6 Conditions that are caused or exacerbated by these risk factors include cardiovascular disease, type 2 diabetes mellitus, liver disease and lung cancer. Socioeconomic inequalities in the prevalence and treatment of these conditions are major contributors to overall inequalities in health and well-being.

The number of alcohol-related deaths in the UK is increasing and has almost doubled since 1991; higher rates of excessive alcohol intake and alcohol-related deaths are reported in those living in areas of social deprivation. 7 In addition, for men in unskilled low-paid occupations, the rate of alcohol-related mortality is around 3.5 times greater than in those in managerial and professional occupations. For women, this figure is even higher, with those in unskilled low-paid occupations at around 5.7 times greater risk of alcohol-related mortality than those in managerial and professional occupations. 8 In the UK, the highest number of preventable deaths are attributable to smoking,9 with approximately half of all life-long smokers dying prematurely, losing on average about 10 years of life. 10 It is estimated that up to 86,500 preventable deaths each year can be attributed to smoking in the UK. 11 In the UK, smoking rates declined to around 21% in 2007 and have since plateaued;12 smoking rates are greatest in low socioeconomic groups. 13 The prevalence of obesity in both children and adults remains relatively high in the UK compared with most other European countries,14,15 particularly in areas of social deprivation. The prevalence of obesity in women living in the UK is highest among those living in areas of social deprivation, but the association in men is less clear. 16

Existing relevant reviews were unable to assess the effectiveness of community pharmacy-delivered alcohol, smoking and weight management interventions because of a limited evidence base. 17–19 However, more interventions have been carried out since these reviews were conducted and the evidence base requires updating. In 2008, the DH2 stated it was crucial to develop ‘a sound evidence base that demonstrates how pharmacy delivers effective, high quality and value for money services’, and this systematic review aims to respond to this requirement.

Community pharmacies

Community pharmacies in the UK are often the most accessible and available health-care provider to the community, and higher numbers of community pharmacies are found in areas of high social deprivation. In England, there are over 10,500 community pharmacies, distributed across urban and rural areas,11 allowing the public to access health care without an appointment. These community pharmacies are open at convenient times, including evenings and weekends, allowing access for people who work a wide range of hours. This situation has consistently improved in recent years in England, with policy drives to improve access to medicines, including the promotion of ‘100-hour pharmacies’, which must open 100 hours per week for every week of the year. 2 Eighty-nine per cent of the population in England can access a pharmacy from home within a 20-minute walk. Importantly, in areas of highest deprivation, this value increases to almost 100%. 20 Estimates vary with regard to the reach of the community pharmacy network, but it is thought to be relatively high: a survey published in 2008 found that 95% of the population of Scotland make at least one visit during any 1 year. 21

Many community pharmacies now offer smoking cessation services and a few offer alcohol reduction and weight management services. 22 Currently, six local pharmaceutical committees (LPCs) have weight management services, 14 LPCs have alcohol services and there are 81 stop smoking services (some LPCs have more than one service covering different areas). These services are delivered by pharmacists, pharmacy technicians and counter assistants. The specific types of interventions are wide-ranging and include two main approaches: pharmaceutical related [e.g. supplying nicotine replacement therapy (NRT) for smoking cessation] and non-pharmaceutical related (e.g. providing advice on behaviour change strategies), or a combination of both approaches. At present, many of these services are commissioned by the local authority according to local need: all services are delivered to an agreed framework specification that allows for variations in the delivery of the service at a local level.

Summary

Excessive alcohol intake, smoking and obesity are three of the most significant modifiable risk factors for morbidity and mortality in the UK. The rates of excessive alcohol intake, smoking and obesity are all greater in lower socioeconomic groups, significantly contributing to overall inequalities in health. Within the UK, community pharmacies are potentially the ideal setting in which to deliver health-care interventions to reduce risk factors for disease. Community pharmacies are easily accessible; they are widely distributed, often in areas of highest deprivation, and many are open long hours. The unique access characteristics of community pharmacies may be more attractive to individuals who cannot, or choose not to, access conventional health-care providers. In addition to conventional health-care provision, community pharmacists can provide opportunistic health care. Community pharmacists can play a significant role in improving risk factors for disease through modifying health behaviours, such as through the management of alcohol consumption, smoking cessation and weight loss. All these factors taken together indicate that community pharmacists and the wider pharmacy team have the potential to deliver health-care interventions to those hardest to reach and arguably those most in need, and in so doing may reduce the socioeconomic inequalities in the prevalence and treatment of modifiable risk factors for disease.

The DH has identified interventions aimed at managing alcohol, smoking and weight, delivered by community pharmacists as public health priorities. We currently do not know how effective such community pharmacy-delivered interventions are. This systematic review assesses the effectiveness of such interventions and is of relevance to those responsible for policy and practice in many countries that are trying to tackle obesity, smoking and alcohol misuse, where one option is to deliver interventions through community pharmacies. Specifically, this review aims to help those commissioning public health services in the UK to determine which pharmacy-delivered interventions are effective, good quality and value for money.

Objectives

1. To assess the effects of community pharmacy interventions on health and health behaviours in relation to alcohol misuse, smoking cessation and weight management.

2. To explore if and how socioeconomic status (SES), sex, ethnicity and age moderate the effect of the interventions.

3. To describe how the interventions included in the review have been organised, implemented and delivered.

Interventions

The review included any type of intervention based in any country and in people of any age. The review included interventions that focused on alcohol misuse, smoking cessation and weight management. As there was no restriction on the type of intervention, interventions could include multiple lifestyle interventions that encompassed more than one component (e.g. smoking cessation and weight management). There was no restriction on the type of participant and so interventions could include participants with comorbidities such as cardiovascular disease or type 2 diabetes mellitus. There was no restriction on the type of comparator and could include a non-active control/usual care, or another type of active intervention set inside or outside the community pharmacy; the comparator could be an identical intervention carried out in a setting other than the community pharmacy. There was no restriction on study duration.

The setting of interest was the community pharmacy, which was defined as a pharmacy set in the community that is accessible to all and not based in a hospital, clinic or online. The participants could be recruited from outside the community pharmacy setting as long as the intervention was carried out from the community pharmacy. The intervention had to be led by the community pharmacist or the wider pharmacy team comprising the pharmacist, pharmacy assistant and/or pharmacy technician; however, the intervention could also include other deliverers as part of a multidisciplinary team. Interventions led by the pharmacist or the wider pharmacy team that took place outside the community pharmacy were excluded. Table 1 details the study eligibility criteria.

Study design

From the results of our initial scoping search it was anticipated that there would be insufficient evidence from randomised controlled trials (RCTs) alone and so all studies with a control group were included. Using the Cochrane Effective Practice and Organisation of Care study design criteria,28 the types of study design included in the review were as follows: RCTs, non-randomised controlled trials (nRCTs), controlled before-and-after studies (CBAs), interrupted time series and repeated measures studies. Before-and-after studies without a control group and all cross-sectional studies were excluded because it is impossible to attribute causation from such study designs.

Evidence from uncontrolled studies was excluded from this review, but has been identified for possible future research. Throughout the screening process, any reference that appeared to be an uncontrolled before-and-after study that otherwise seemed to fit the inclusion criteria were identified. It was considered important to identify these types of studies, which cannot inform issues of effectiveness but may inform future areas of research around issues such as the recruitment and retention of participants and the demographic and SES of participants accessing community pharmacy-based settings.

Search strategy

Ten electronic databases were searched (host sites given in parenthesis): MEDLINE (via Ovid), EMBASE (via Ovid), Cumulative Index to Nursing and Allied Health Literature (NHS Evidence Health Information Resources), PsycINFO (NHS Evidence Health Information Resources), Social Science Citation Index (Thomas Reuters’ Web of Science), Applied Social Sciences Index and Abstracts (via Cambridge Scientific Abstracts), International Bibliography of the Social Sciences (via EBSCOhost), Sociological Abstracts (via Cambridge Scientific Abstracts), Scopus (Elsevier) and the NHS Economic Evaluation Database (via the NHS Centre for Reviews and Dissemination).

Two reviewers developed the electronic searches (HJM and LS) using medical subject headings and text words using terms for pharmacy, alcohol, smoking cessation and weight. During development of the search we used the studies that were identified as relevant in our previous scoping search as a cross-check to see if the search strategy identified the same studies, this acted as a method of checking the sensitivity of the search strategy. All databases were searched from inception (e.g. MEDLINE starts in 1946) to May 2014. The MEDLINE search is detailed in Appendix 1. There was no restriction on publication date or language.

In order to capture all relevant evidence, various supplementary approaches were used to identify additional published, unpublished and ongoing studies. The electronic database searches were supplemented with website (Google) and grey literature searches (OpenGrey, Social Care Online, Prevention Information & Evidence eLibrary and Nexus UK). The International Standard Registered Clinical/Social Study Number registry and the National Research Register were also searched. The bibliographies of all included studies were hand searched; experts in the field were contacted as well as authors of ongoing studies.

Outcomes

The primary outcomes of this review were behavioural outcomes; a causal modelling framework29 was used to conceptualise behavioural outcomes. The framework contains four categories: (1) determinants of behaviour; (2) behavioural outcomes; (3) physiological and biochemical outcomes; and (4) health outcomes. Interventions for smoking cessation and alcohol consumption had to report a relevant behavioural outcome in order to be included (e.g. quit rates and change in alcohol intake, respectively). For weight loss interventions, studies had to report an anthropometric outcome (physiological) to be included [e.g. weight, body mass index (BMI), waist-to-hip ratio]. There were no other restrictions on study inclusion by type of outcome. Outcomes that were measured, observed or self-reported were included.

The secondary outcomes of this review were any differential effects of the interventions by sociodemographic status (age, ethnicity, sex) or SES (as measured by education, income, occupation, social class, deprivation or poverty), or interventions that were targeted at disadvantaged groups.

Contextual data on the organisation, implementation and delivery of interventions were extracted using the methodological tool for the assessment of the implementation of complex public health interventions in systematic reviews developed by Egan et al. 30 for the workplace and adapted by Bambra et al. 31 for obesity interventions. Examples of components of the organisation, implementation and delivery of interventions include theoretical underpinning and strategies used to change behaviour; implementation context; consultation and/or collaboration process; sustainability; stakeholder support; staff training and quality assurance; experience of the intervention team; and resources and other intervention-related costs. The Behaviour Change Wheel32 and the Nuffield Intervention Ladder33 were chosen to broadly describe the interventions by grouping and classifying the policy categories and intervention functions. We also provide a brief description of the theoretical models which underpinned the interventions and the behaviour change strategies used within each intervention, mostly paraphrasing the original papers.

Data extraction and quality appraisal

The initial screening of titles and abstracts was conducted by three reviewers (CM, HM and SS). The screening of full-text papers was conducted by two reviewers (CM and TB) with any disagreement or uncertainty about inclusion resolved through discussion with two other reviewers (AT and CS). Data extraction and quality assessment was conducted independently for each study by two reviewers (from AT, CM, CS, HM, LN, LS, SS and TB). The data extraction form is detailed in Appendix 2. Data were extracted on the study characteristics, service provider characteristics, outcomes, demographic and socioeconomic variables, and costs.

The quality of the included studies was appraised using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies34 (see Appendix 3), which is recommended by the Cochrane Public Health Review Group. 35 Any discrepancies in the data extraction or quality assessment were either resolved through discussion or ultimately referred to a third reviewer for final assessment (TB). The quality assessment was used within the narrative synthesis to highlight variations between studies.

Analysis and synthesis

Owing to the heterogeneity of the studies, it was possible to conduct meta-analyses for the smoking cessation studies only. The analyses were performed using the R package meta (The R Foundation for Statistical Computing, Vienna, Austria). The smoking data were analysed using a binomial–normal random-effects model. In order to explain the observed heterogeneity between studies, four different meta-regression models were fitted, accounting for whether an active control group or usual care was used, duration of the intervention and the global quality assessment ratings. Q-statistics and the percentage of heterogeneity between studies were reported for each metaregression model. The optimum metaregression model was chosen using a minimum Akaike information criterion. Where meta-analysis could not be performed, as was the case with the weight data, the change data were described using a bar chart. Owing to the limited available data and lack of informative priors, the planned analysis as described in the protocol24 was not performed in R instead of Stata (StataCorp LP, College Station, TX, USA) or WinBUGS (MRC Biostatistics Unit, Cambridge, UK) for the same reason. A funnel plot for the smoking cessation RCTs was carried out to indicate (but not diagnose) the possible presence of publication bias: intervention effect estimates from individual studies were plotted on the horizontal axis and the standard error of the intervention effect estimate was plotted on the vertical axis. A triangular region was plotted, within which 95% of studies would be expected to lie in the absence of both biases and heterogeneity. 23 Narrative synthesis was conducted for all the included interventions.

Studies eligibility

The titles and abstracts of 14,011 records were screened for inclusion; 13,939 were excluded because inclusion criteria were not met. Inclusion criteria were all types of controlled trials set in a community pharmacy and delivered by the pharmacist or the wider pharmacy team with a focus on alcohol misuse, smoking cessation and weight management. Any type of intervention of any duration based in any country and in people of any age was included. Seventy-two records were obtained as full-text articles because on initial screening it appeared these records might fit the inclusion criteria. Twenty-four studies were finally included and full references are listed in Appendix 4. An additional three studies are ongoing and are listed in Appendix 5.

The process of inclusion and exclusion of studies is detailed in Figure 1. Of the 72 full-text articles that were screened, eligibility was unclear in 10 articles,36–45 and this was resolved through discussion among reviewers (AT, CO, CS, TB). Uncertainty mainly arose regarding whether the intervention was set in a community pharmacy or led by pharmacy staff, or the outcomes (e.g. where studies reported composite measures or where outcomes specific to the pharmacy-based element could not be picked out). The reasons for the exclusion of papers at the full-text stage (n = 40) are detailed in Appendix 6. Fifty-four studies that otherwise appear to fit the inclusion criteria were identified as uncontrolled before-and-after studies; these references are listed in Appendix 7.

FIGURE 1.

The PRISMA flow diagram for studies.

UK alcohol service evaluations

Our initial scoping search of the literature revealed a dearth of information from controlled studies of community pharmacy alcohol screening and brief intervention services. Therefore, a search was undertaken to identify any uncontrolled evaluations undertaken in the UK of community pharmacy alcohol screening and brief advice interventions.

Additional searches for these types of evaluations were carried out between March 2014 and July 2014 and included contacting (1) commissioners of such services; (2) providers of such services; and (3) experts in the academic community who have published in this field. Commissioners included all local authorities in England and all health boards in Scotland and Wales were contacted. The head of the Pharmaceutical Services Negotiating Committee (PSNC) was contacted. Key individuals responsible for commissioning alcohol services were contacted in NHS Scotland and NHS Wales. Providers including LPCs in England were contacted through the PSNC. An advert was taken out in the PSNC newsletter, which was then e-mailed to all LPCs. Similarly, Community Pharmacy Wales and Community Pharmacy Scotland were also contacted by e-mail. An advert was also taken out in The Pharmaceutical Journal asking for any evaluations in relation to community pharmacy and alcohol interventions to be sent to the research team. The Pharmaceutical Journal is sent to all pharmacists who are affiliated with the Royal Pharmaceutical Society (≈30,000 pharmacists) in the UK. Experts in the field including academics who have previously published in this area were contacted; information was also requested through Twitter (Twitter, Inc., San Francisco, CA, USA) and LinkedIn (LinkedIn, Mountain View, CA, USA). Authors were contacted of relevant conference abstracts from the Royal Pharmaceutical Society Conference (2010–14 inclusive), the Academic Health Services Research and Pharmacy Practice Conference (2010–14 inclusive) and the International Network on Brief Interventions for Alcohol and Other Drugs (2010–13 inclusive).

The results from these types of evaluations are reported separately and alongside the synthesis of effectiveness results from the included controlled interventions. Because these reports are not published in peer-reviewed journals and are uncontrolled service evaluations, they were not formally quality assessed (unlike the effectiveness interventions).

Study characteristics

Tables 2–5 provide study characteristics for each type of intervention focus (alcohol, smoking, weight and multicomponent, respectively). Twenty-four studies were included in this review (29 papers). There were two alcohol interventions,46,48 12 smoking cessation interventions,44,45,49–53,55–60,63 five weight-loss interventions39,64–67 and five multicomponent interventions that included pharmacotherapy and lifestyle changes in participants with comorbidities including dyslipidaemia (n = 1 study),71 hypertension72 and type 2 diabetes mellitus (n = 3 studies). 68–70 Four studies had multiple publications, one smoking cessation study had an English63 and a Danish73 publication; another smoking cessation study49 had two additional publications including a paper on cost-effectiveness51 and a paper on shorter-term follow-up. 50 Another smoking cessation study60 had an additional publication on cost-effectiveness. 61 One multicomponent intervention had an English72 and a Spanish publication. 74 We extracted data from all these additional publications with the exception of the Danish73 and the Spanish publication. 74 Three smoking cessation interventions52,55,60 appeared to be targeted at pharmacy staff as well as clients; the remaining 21 studies were targeted at pharmacy clients alone. There were 19 RCTs,44–46,48,52,53,55,57–60,63,64,66–68,70–72 three nRCTs39,56,69 and two CBAs. 49–51,65 There were 22 published journal articles39,44–46,49–53,55–60,63,64 and two reports. 48,65 Nine studies were conducted in the UK,46,48–51,56,65,66,68 four in the USA,39,44,52,64 two each in Australia,45,53 South America69,71 and Spain,69,70 and one each in Canada,55 Denmark,63 Japan,59 Thailand67 and the Netherlands. 57

Seventeen studies recruited participants within the community pharmacy; other recruitment settings included hospital/primary care units, via telephone and a community health centre. The intervention setting was always a community pharmacy (for at least one intervention group); the types of pharmacies included single outlets, small chains and large chains. Pharmacies were set in rural, urban and a combination of both geographical settings. The number of pharmacies included within each study ranged from 1 to over 200. Participant sample size ranged from 28 to around 7000, resulting in approximately 14,000 service users in total.

All studies reported participant demographic characteristics and some reported socioeconomic details at baseline. Twenty-three studies reported age and sex, 13 studies reported education levels; seven studies reported ethnicity, two studies reported income, four studies reported employment/occupation and three studies reported marital status. Five studies (one alcohol management, two smoking cessation and two weight loss) reported the SES of participants using versions of deprivation scores. One smoking cessation study reported a ‘socioeconomic group score’ which was a composite measure of education levels, single parent status, housing status, employment status, sickness, free prescription eligibility and deprivation.

All studies were of adults and the mean age ranged from 24.2 to 67.4 years. Participants in a study of a photoageing intervention were much younger (mean age 24.2 years) than the majority of the participants because this intervention was specifically targeted at smokers aged between 18 and 30 years. In terms of sex, across all the studies there was a majority of female participants. Across all the studies the percentage of females ranged from 36% to 93%; however, when the weight loss trials were excluded, the percentage of females ranged from 36% to 69%. In the weight loss studies the majority of participants (> 70%) were female. There were two exceptions, both smoking cessation studies: one Japanese study59 reported 18.5% females (5/27) and in one US study44 99% were male; this reflected the target population, which comprised tobacco-chewing participants, who tend to be predominantly male.

The majority of participants in five44,48,52,66,68 out of the seven studies44,46,48,52,65–67 that reported ethnicity were white. In one weight loss intervention, four-fifths of participants were from black and ethnic minority groups. In one alcohol intervention46 based in the inner London Borough of Hammersmith and Fulham, 20% of participants were Asian, black, mixed, Chinese or other.

Three studies49–51,65,66 appeared to adopt a targeted approach to addressing inequality, recruiting a majority of participants from areas of high deprivation. All three studies compared a pharmacy-based setting with other settings. Bauld et al. 49–51 compared smoking cessation services that were group-based in the community with one-to-one pharmacy-based services; both services were attended by a larger proportion of women than men. The smaller number of clients who attended the group service were older, slightly more affluent (although still a relatively deprived group) and more likely to be women. Bush et al. 65 compared a weight management programme set in pharmacies versus the same programme set in general practitioner (GP) surgeries. GP surgery participants tended to be older than pharmacy participants and ethnic composition of the two groups differed significantly. The mean Index of Multiple Deprivation (IMD) score of participants at GP surgeries and pharmacies was 43.8 and 43.3, respectively. Jolly et al. 66 compared a range of NHS and commercial weight loss programmes including a pharmacy-based intervention; 73.4% of participants were from the two most socioeconomically disadvantaged quintiles of the population. The mean IMD score of participants in the GP surgery and pharmacy arms were 32.2 and 35.1, respectively; higher IMD scores indicate greater deprivation.

Eligibility criteria for participants in the two alcohol interventions46,48 included a minimum score that indicated possible harmful or hazardous alcohol consumption but not alcohol dependence. Eligibility criteria for participants in the smoking cessation interventions consisted of measures of nicotine dependence, which varied across the interventions. Four studies52,57–59 reported the baseline number of cigarettes smoked per day, and this ranged between 20 and 23 cigarettes per day for three studies;52,58,59 and one study reported a baseline of 42 cigarettes per day. 58 Another four studies reported only Fagerström scores (scored 0–10, with higher scores reflecting a greater dependence on nicotine), which ranged from 3 in a group of young adults with a mean age of 24 years53 to around 6 for three studies. 45,60,63

The degree of overweight or obesity varied across the five weight loss interventions; all interventions specified a minimum BMI at baseline and the mean BMI ranged from 27.7 kg/m2 to 44.9 kg/m2. 39,67

Intervention components varied considerably across all 24 studies and specific study intervention details are reported alongside the individual study results. Duration of follow-up (from baseline to end) ranged from 5 to 56 weeks. Where the duration of a study is referred to, this is defined as from baseline to final follow-up.

In terms of outcomes, both the alcohol interventions used self-reported questionnaires to evaluate change in alcohol behaviours. Half (6/12) of the smoking cessation interventions relied on self-reported change in smoking behaviours45,55,57,59,60,63 and half used biochemical measures44,49–53,56,58 [carbon monoxide (CO) or cotinine levels] to validate change in smoking behaviours. All five of the weight loss interventions39,64–67 and all five multicomponent interventions67–72 (pharmacotherapy plus lifestyle changes) measured weight. Five studies assessed health status or quality of life. 39,46,65,68,70 Eight studies reported cost outcomes. 48,49–51,56,60,65,66,69

Only four studies assessed whether or not certain demographic variables moderated the effect of interventions; all four studies48,60,65,66 assessed the differential effects of sex and one of these studies also assessed age. 65 No study assessed the differential effects of any measure of SES. Few studies used regression analysis to assess the influence of demographic or socioeconomic variables on change from baseline, in other words as potential predictors of outcomes within intervention groups or to explain retention.

Funding sources were stated in 16 studies;44–46,48–52,55,58,60,63–68,70 the types of funding sources included academic research bodies, health-related institutions, commercial organisations and pharmaceutical companies, with some studies receiving funding from a combination of different types of sources.

Study quality

Twenty-four studies39,44–46,48–53,55–60,63–72 were assessed for quality [three ongoing studies (see Appendix 5) were not quality assessed] using six criteria: (1) selection bias; (2) study design; (3) confounders; (4) blinding; (5) data collection methods; and (6) withdrawals/dropouts. Each study was given an overall (global) rating based on the ratings for the six criteria (Table 6).

Implementation of interventions

Implementation was evaluated using the tool30,31 for the assessment of the implementation of complex public health interventions in systematic reviews; this tool covered three key domains: organisation, implementation and delivery of interventions. In addition, the Behaviour Change Wheel32 and the Nuffield Intervention Ladder33 were used to broadly describe the interventions by grouping and classifying the policy categories and intervention functions.

Effects of interventions

Study outcomes are summarised in Tables 8–11 for each type of intervention focus (alcohol, smoking, weight and multicomponent). Costs are summarised in Table 12. Demographic and socioeconomic variables are summarised in Table 13. See Appendix 11 for detailed outcomes for all studies.

Smoking cessation interventions

There were 10 RCTs,44,45,52,53,55,57–60,63 one nRCT56 and one CBA49–51 of smoking cessation interventions in adults. Table 9 summarises the results. Follow-up ranged from 5 weeks to 12 months. Quit rates within the pharmacies ranged from < 1% to 56%. Global ratings for studies varied: four studies57,59,60,63 were rated strong, three moderate44,52,53 and five weak. 45,49–51,56,58

Eleven smoking cessation studies44,45,49–53,55,57–60,63 carried out analyses with the assumption that those lost to follow-up had not stopped smoking. Details of the type of analysis used to measure effectiveness were not reported in one study. 56 Some studies also included completer analyses; however, we focus on results from the largest data set within each study and on the longest follow-up. Numbers of participants ranged from 2859 to approximately 7000,55 with the majority of studies including between 300 and 600 participants. Half (6/12) of the smoking cessation interventions relied on self-reported change in smoking behaviours45,55,57,59,60,63 and half used biochemical measures (CO or cotinine) to validate change in smoking behaviours. 44,49–53,56,58

Of the 12 smoking cessation studies, 10 included NRT (in either the intervention or control group or both). 44,45,49–51,55,56,58–60,63 Eleven of the studies44,45,49–53,55–60 included some form of behavioural support/advice/counselling. There was only one study63 which specifically reported that no psychological or behavioural support was added to the pharmacological treatment.

In terms of the component which is evaluated, seven studies52,55–60 evaluated some form of behavioural support, four of which compared behavioural support with a non-active control that received usual care. 52,57,58,60 In two studies,56,59 the behavioural support component was evaluated as an ‘additional’ element; the participants also received NRT in both the intervention and control arms. Another study55 compared 1 week of NRT then fortnightly pharmacy visits for NRT plus three sessions of brief behavioural counselling with 5 weeks NRT at the initial pharmacy visit plus one session of brief behavioural counselling at the initial visit.

Four studies44,52,56,63 evaluated a NRT component: one study compared NRT with placebo NRT,63 another study compared NRT with non-active control56 and two studies assessed NRT as an additional element (i.e. the participants also received behavioural support in both the intervention and control arms). 44,52 Three studies evaluated behavioural support plus NRT compared with non-active usual care. 45,52,56 Two studies evaluated the effect of the setting of the intervention; one study assessed behavioural support plus NRT provided in a hospital outpatient setting compared with pharmacy setting. 45 One study compared individual pharmacy-based behavioural support plus NRT with group support provided in a community setting. 49–51 One study53 evaluated the effect of a photoageing intervention in which both the intervention and control groups received pharmacist advice.

Behavioural outcomes

Eight studies45,52,53,56–58,60,63 evaluated an active pharmacy-based intervention in comparison with a non-active or usual-care control condition; five52,53,56,58,63 showed significant improvements compared with control. Five studies evaluated an additional element to an intervention:44,52,55,56,59 the additional elements included NRT in two studies44,52 and behavioural counselling/advice in another three studies. 55,56,59 One study52 showed significant improvements with the addition of NRT to tailored counselling and one study showed significant improvements with the addition of behavioural support to NRT. 56

Only two studies compared pharmacy-based setting with another setting. Bauld et al. 49–51 compared one-to-one pharmacist support with group-based smoking cessation clinics based in the community. All pharmacy clients had NRT, 84% of the group clients had NRT and the remaining 16% of the group clients received oral medication. The participants chose the service, rather than being assigned by study investigators. The group-based service attracted fewer clients but was significantly more effective than the pharmacy-based service in terms of the proportion of participants who were not smoking at 12 months (6.3% vs. 2.8%), determined using validated measures. However this study was observational only and the effectiveness results should not be directly compared in any formal manner. Vial et al. 45 compared pharmacy counselling with outpatient counselling and there was no significant difference in smoking cessation between the groups.

A RCT52 of training pharmacists to provide a tailored counselling service with and without NRT compared with a non-randomised control group that received observation only showed a significant increase in validated 7-day point prevalence at 6 months (28% for counselling and NRT, 15% for counselling only, 8% for control).

One RCT53 compared the addition of a computer-generated photoageing service (demonstrating the detrimental effects on facial physical appearance of smoking) with standard smoking cessation advice in a pharmacy. The photoageing intervention was more effective than the control based on the proportion of participants (young people with a mean age of 24 years) who were not smoking at 6 months [13.8% (n = 11/80) vs. 1.3% (n = 1/80)], determined using CO-validated measures. This difference between groups remained statistically significant after adjustment for small differences between groups in sex and nicotine dependence.

Another RCT55 evaluated three sessions of pharmacist counselling to one session based on the 5-A model for brief behavioural counselling in addition to both groups receiving 5 weeks of free NRT. There was no significant difference between intervention groups for self-reported 7-day point prevalence at 5 weeks, controlling for covariates [odds ratio (OR) 0.96, 95% CI 0.86 to 1.08]. At 5 weeks, the self-reported 7-day point prevalence was 17.5% for participants receiving three sessions of counselling and 18% for those receiving just one session. Approximately 50% of ‘three-session’ participants completed all three sessions, and among these participants quit rates were significantly higher than among the group of ‘one-session’ participants (27.7% vs. 18%).

Computer-generated tailored advice, compared with a thank-you letter,57 did not increase self-reported 6-month abstinence in participants recruited from Dutch pharmacies (quit rates < 1% in either group). The pharmacists were involved only in making the questionnaires available to customers.

One study44 evaluated the addition of 6 weeks of free NRT (compared with placebo NRT) to pharmacist advice and support in participants who were tobacco chewers. Validated abstinence rates were relatively high at the 6-month follow-up but not significantly different between groups (38% for NRT group vs. 34% for placebo group).

A RCT58 evaluated the Pharmacist Action on Smoking (PAS) model compared with ad hoc smoking cessation advice in UK pharmacies; over 80% in each group also received NRT. The PAS intervention significantly increased validated smoking cessation compared with control at 12 months (14.3% vs. 2.7%).

A small Japanese study59 evaluated the additional effect of initial and follow-up cessation advice to nicotine gum (plus advice on usage). Both interventions appeared to increase cessation but it was not reported if there was a significant improvement from baseline to follow-up. There was no significant difference between groups in self-reported cessation at 3 months (45.5% vs. 31.2%).

A UK RCT60 compared training pharmacists and pharmacy assistants in the stages-of-change model of smoking cessation with standard professional pharmacist care. Intervention participants were significantly more likely than control participants to purchase an ‘anti-smoking’ product. The intervention was associated with a favourable non-significant trend at 9 months, but this was based on self-reported abstinence, and pharmacists were willing to participate before randomisation. Self-reported continued abstinence at 9 months was 12% in the intervention group versus 7.4% in the control group.

A Danish study63 evaluated the effect of two different strengths of over-the-counter nicotine patches compared with placebo. No psychological or behavioural support was added to the pharmacological treatment. Self-reported point prevalence included participants who had one episode of smoking (< 6 days). Those smoking ≥ 20 per day at baseline were randomised to 21-mg patches or placebo; those smoking < 20 per day at baseline were randomised to 14-mg patches or placebo. At 26 weeks the intervention was effective compared with placebo for those smoking ≥ 20 per day at baseline (11% vs. 4.2%) but not for lighter smokers (22.7% vs. 18.4%).

One RCT45 compared 16 weeks of nicotine patches plus weekly counselling delivered by pharmacies with the same treatment delivered in a hospital outpatient clinic; a minimal intervention control group received written and verbal information at baseline only. Participants were all former inpatients of a respiratory unit and the intervention commenced while participants were inpatients then continued after discharge (as either outpatient- or pharmacy-based treatment). Seven-day point prevalence, but not continuous abstinence, was significantly different in favour of the pharmacy- and outpatient-based intervention compared with control intervention at the 12-month follow-up. Self-reported continuous abstinence at 12 months was 19% in the pharmacy-based group versus 24% in the outpatient group and 4.6% in the control group.

A cost-effectiveness study56 carried out in two pharmacies in Northern Ireland compared a behavioural intervention based on the PAS model with a nicotine gum-only control. Another control group comprised participants who expressed a wish to stop smoking and who were chosen on the basis that they matched, in terms of age, sex, social status and disease status, those in the behavioural intervention group. The study was a cost-effectiveness analysis and did not report many participant details. At 6 months there was a statistically significant difference in cessation rates between intervention and control patients. The 6-month CO-verified abstinence was 46% in the intervention group versus 6% in the control group receiving only nicotine gum and 0% in the control group that expressed a wish to stop smoking.

Metaregression and meta-analysis

Table 14 shows the results of metaregression for the smoking interventions. In model 1, we fitted a random-effects model including all 10 RCTs. The pooled OR for the intervention effects was 1.85 (95% CI 1.25 to 2.75), an indication of positive effect of the interventions on participants smoking cessation. However, there was 72% unexplained differences between the studies. In model 2, we fitted a metaregression model accounting for whether a study had active control or usual care. The pooled ORs were 1.21 (95% CI 0.86 to 1.71) and 2.56 (95% CI 1.45 to 4.53) for the active control and usual care, respectively. As expected, there was a bigger effect for usual care than for the active control. The proportion of unexplained heterogeneity reduced to 52%. In model 3, we accounted for whether a study had active control or usual care and also the duration of the interventions; the unexplained heterogeneity reduced to 27.2% with a non-significant Q-statistic test (10.99; p < 0.2026). In model 4, we accounted for quality rating. The quality rating does not appear to contribute much to the model after accounting for intervention duration and whether a study had active control or care as usual.

TABLE 14 - Metaregression

AIC, Akaike information criterion.

Smallest AIC value indicates the most optimum model for the data.

Q-statistic test for the significance of heterogeneity between studies.

I² quantifies the percentage of unexplained heterogeneity between the studies.

Model	Variables	AICa	Q-statisticb (quantile; p-value)	c I 2
1	–	27.63	35.78; p < 0.0001	72.0%
2	Active control (or usual care)	26.21	18.73; p < 0.0276	52.0%
3	Active control + intervention duration	23.69	10.99; p < 0.2026	27.2%
4	Active control + intervention duration + global rating	26.07	8.14; p < 0.2277	26.3%

The meta-analysis results by study groups (active control or usual care) and the overall pooled ORs, are presented in Figures 2 and 3, presents the same meta-analysis results by quality ratings. There is asymmetry in the funnel plot in Figure 4, which may be a reflection of publication bias. In the absence of bias, the plot should approximately resemble a symmetrical (inverted) funnel; however, Figure 4 shows a gap in one corner of the graph, which could indicate the presence of bias, including publication bias, with smaller studies without significant effects not being published. Such a pattern is compatible with publication bias, on the assumption that smaller studies with uninteresting effects are withheld from publication. However, the funnel plot must be interpreted with caution, taking into account that it contains only 11 studies which just exceeds the recommended study size threshold (n = 10) for creating such plots. 23

FIGURE 2.

Meta-analysis of smoking data accounting for whether active control or usual care. a, 21-mg nicotine patches/placebo; b, 14-mg nicotine patches/placebo.

FIGURE 3.

Meta-analysis of smoking data accounting for global quality assessment ratings. a, 21-mg nicotine patches/placebo; b, 14-mg nicotine patches/placebo.

FIGURE 4.

Funnel plot.

Costs

The CBA49–51 included a cost-effectiveness analysis, using validated quit rates for an economic evaluation of both the annual and the lifetime cost-effectiveness of the pharmacy- and group-based interventions in comparison with a baseline ‘self-quit’ scenario. At 52 weeks, the group service achieved a higher quit rate (6.3%) than the pharmacy service (2.8%) but was more intensive and required greater overhead costs. The Markov model estimated the potential lifetime outcomes in terms of cost per quality-adjusted life-year gained. The lifetime analysis resulted in an incremental cost per quality-adjusted life-year of £4800 for the group support and £2600 for pharmacy one-to-one counselling. Cost per pharmacy-based client was £79 based on a 0.025 probability of a 52-week quit. The paper reports that both services were considered to be highly cost-effective despite relatively low quit rates.

One RCT61 included a cost-effectiveness analysis using self-reported continued abstinence at 9 months (12% in the intervention group vs. 7.4% in the control group). Costs included those borne by the health service and pharmacies, but also by clients (societal perspective). Training costs included organising and operating costs of the training sessions and trainees’ out-of-pocket expenses, including staff costs and travel plus lost leisure time. Cost to the client included NRT and counselling time. Cost to the pharmacy covered training and counselling time. Any NRT purchased was a cost of the intervention to the client (total cost per user for NRT was £47.53). Cost to the NHS comprised organising and operating costs, pharmacy travel expenses and promotional materials and client documentation. The cost of producing one additional successful attempt to quit smoking by using intensive rather than standard pharmaceutical support was £300 or £83 per life-year.

A RCT53 of a photoageing intervention assessed the cost-effectiveness from a health sector perspective, in terms of the incremental cost per additional quitter and per additional lifetime quitter. Direct costs over and above providing standard cessation advice were calculated based on the time taken to provide the service and the cost to a pharmacy of purchasing tokens to use the online software to photoage participants. Potential cost offsets were based on the quit benefits model, which is a tool developed in Australia to predict the difference in health-care costs of smokers and non-smokers for males and females by age group after 10 years’ follow-up.

In the intervention group, 22 of 80 participants (27.5%) reported quitting, with 11 of 80 participants (13.8%) confirmed by CO testing. The difference between groups was significant even after adjustment for baseline differences. The incremental cost-effectiveness ratio (ICER) was AU$46 per additional quitter, or the equivalent of AU$74 per additional lifetime quitter. Cost offsets of AU$2144 from a reduction in the health-care costs of quitters resulted in the intervention potentially generating net total cost savings of AU$1778. The mean cost of implementing the intervention was estimated at AU$5.79 per participant. The mean cost that participants indicated they were willing to pay for the digital ageing service was AU$20.25 [standard deviation (SD) AU$15.32], which was more than the actual costs.

A cost-effectiveness study56 conducted in two pharmacies in Northern Ireland compared a behavioural intervention group based on the PAS model with a nicotine gum-only control group. The 46% quit rate of the intervention study was not used for cost-effectiveness analysis: a 10% quit rate was used to reflect the participants who entered stage 3 of the PAS programme (i.e. those who set a quit date) and who remained abstinent at 12 months. Various assumptions were also made, including uptake by pharmacies, recruitment of participants, natural cessation rate and relapse rates. The cost-effectiveness of the PAS model was therefore measured in terms of cost per life-year gained for all patients who entered stage 3 of the PAS programme. The main cost-effectiveness analysis indicated that costs ranged from £196.76 to £351.45 per life-year saved for men, and from £181.35 to £772.12 per life-year saved for women, depending on age at intervention. Given the baseline assumptions and on the basis of a 45-year-old smoker, the cost per successful intervention was £509.60. The PAS model appears effective and, if the PAS smoking cessation programme were to be offered routinely by community pharmacists throughout Northern Ireland, it would be cost-effective.

Differential effects by demographic or socioeconomic factors

Five smoking cessation studies44,49–51,53,55,60 reported examining demographic and/or socioeconomic characteristics as potential predictors of outcomes within intervention groups. One study was rated strong for global quality,60 one was rated moderate44,53 and three were rated weak. 49–51,55

Bauld et al. 49–51 compared smoking cessation services that were group based in the community with one-to-one pharmacy-based services; at 52 weeks, group-based clients were more likely to quit than pharmacy clients. Older people were more likely to quit in either the pharmacy-based or the group-based service, higher SES was associated with long-term abstinence for pharmacy clients. Sex did not predict quitting in either the pharmacy-based or the group-based service.

In another smoking cessation study of a photoageing intervention,53 there were no associations between change in Fagerström score (measures nicotine dependence) and age or sex in the control group. However, for the intervention group, age (but not sex) was significantly associated with a change in score. Older participants were significantly less likely to reduce their score than younger participants, suggesting that the intervention may have a greater effect on the younger participants. However, it should be noted that participants in this trial only included an age range of 18–30 years.

Another RCT55 evaluated three sessions of pharmacist counselling to one session based on the ‘5-A’ model for brief behavioural counselling in addition to both groups receiving 5 weeks of free NRT. Bivariate analyses showed that, among three-session completers, both younger and employed individuals were more likely to be abstinent than older and unemployed participants. A study that evaluated the addition of free NRT (vs. placebo NRT) to pharmacist support for tobacco chewers44 examined the active patch group for predictors of relapse: older chewers were less likely to relapse. A UK RCT,60 comparing trainee pharmacists and pharmacy assistants in the stages-of-change model of smoking cessation with standard professional pharmacist care, reported that trends in outcome (in favour of the intervention) were not affected by age, sex or IMD of the participants.

One smoking cessation study reported on demographic or socioeconomic characteristics as potential predictors of outcomes between intervention groups. A Danish study63 compared the effect of two different strengths of over-the-counter nicotine patches and placebo. There were no differences in smoking cessation rates between men and women according to starting dose and treatment.

A summary of the evidence for smoking cessation interventions is provided in Box 2.

BOX 2 - Summary of evidence for smoking cessation interventions

• Twelve studies of varied quality evaluated the effectiveness of community pharmacy-based smoking cessation interventions.

• Pharmacy-based smoking cessation interventions including behavioural support and/or NRT are effective and cost-effective in helping adults to stop smoking, particularly when compared with usual care. A total of 10 RCTs were included in a meta-analysis; the pooled OR of the intervention effects for smoking cessation was 1.85 (95% CI 1.25 to 2.75). The pooled OR was 1.21 (95% CI 0.86 to 1.71) for intervention vs. active control and 2.56 (95% CI 1.45 to 4.53) for intervention vs. usual care.

• Accounting for the type of comparator and the duration of the interventions reduced the unexplained heterogeneity to 27.2%, with a non-significant Q-statistic test (10.99; p < 0.2026).

• Four smoking cessation studies included cost outcomes, but the methods of cost-effectiveness analyses differed, making comparisons difficult. However, three UK pharmacy-based interventions appeared cost-effective, despite relatively low quit rates in one case and a non-significant trend for cessation rates in another case. An Australian study appeared cost-effective (and effective) in increasing quit rates among young adults who were exposed to the detrimental effects on facial physical appearance of smoking using a computer-generated simulation.

• The evidence was too heterogeneous to evaluate which specific types of smoking cessation interventions are the most effective or cost-effective.

Weight loss interventions

Five interventions were designed to evaluate weight loss (three RCTs,64,66,67 one nRCT39 and one CBA65) interventions in adults. Table 10 summarises the results. All but one study included advice regarding diet and physical activity; the other study39 included low-fat dietary advice within an intervention designed to improve adherence to orlistat therapy.

Three studies65–67 compared a pharmacy-based intervention with interventions in various other settings, including commercial weight loss programmes set in community venues, primary care settings such as GP practices, primary care units and outpatient clinics. One study64 compared a meal replacement diet with a conventional low-calorie diet (identical recommended total daily calorie intake); both interventions were set in a pharmacy. One small study39 assessed the added value of community pharmacy support for obesity management in addition to orlistat and an outpatient nutrition programme.

Meta-analysis

There were insufficient data to conduct meta-analyses and so the weight data are described in Figure 5.

FIGURE 5.

Bar chart of weight change from baseline to follow-up by treatment group. P, pharmacist; PA, physical activity.

Behavioural outcomes

Three studies65–67 reported BMI, three studies64,65,67 reported waist circumference (WC) and all five studies39,64–67 reported weight. The largest improvement in BMI59 was –1.3 kg/m2; for WC it was –8.1 cm64 and for weight it was –5.6 kg. 64 None of the studies demonstrated a significant difference in favour of the pharmacy-based intervention compared with the control for any anthropometric outcome.

One UK RCT66 compared eight groups [Weight Watchers™ (WeightWatchers.co.uk Ltd, Maidenhead, UK), Slimming World™ (Miles-Bramwell Executive Services Ltd, Alfreton, UK), Rosemary Conley™ (Rosemary Conley Online Ltd, Steyning, UK), Size Down (a NHS community-based group), GP, pharmacy, participants’ own choice and an exercise-only control group]. All except the GP and pharmacy groups exhibited significant weight loss between baseline and 1-year follow-up. At 1 year, only the Weight Watchers group had significantly greater weight loss than the control group (mean 2.5 kg, 95% CI 0.8 kg to 4.2 kg). The commercial programmes (Weight Watchers, Slimming World and Rosemary Conley) achieved significantly greater weight loss than the primary care programmes (general practice and pharmacy-based interventions). At 1 year, the difference was 1.6 kg (0.3 kg to 2.9 kg; p = 0.06) in the adjusted model. Mean weight loss at 1 year, with baseline value used for imputation, was 0.8 kg (SD 4.7 kg) for primary care and 2.5 kg (SD 6.2 kg) for commercial programmes.

In one CBA study65 comparing diet and physical activity in a pharmacy with a GP-based intervention, in both groups BMI, WC and weight appeared to be reduced at follow-up. Statistical significance, either from baseline to follow-up or between groups, was not reported; there was very high attrition in this study (93%). In this CBA, the participants chose the service rather than being assigned by study investigators and, consequently, may have been a relatively more motivated sample.

In two studies,39,64 both the intervention and ‘control’ groups lost a significant but similar amount of weight between baseline and follow-up; participants in both the meal replacement and low-calorie diet groups64 lost a similar amount of weight (both based in the pharmacy) as those treated with orlistat on an outpatient basis,39 with or without additional pharmacy-based support. In one study,67 there was no significant loss of weight between baseline and follow-up in either the intervention or control group.

Costs

Two studies reported costs. 65,66 The CBA65 study reported that it was unclear which provider type (pharmacy or GP) delivered the programme more cost-effectively because of different cost-effectiveness results at different time points. Attendance rates on the programme were consistently better among pharmacy participants than among GP surgery participants. Direct costs included training, initial test and appointments. Providers were reimbursed £300 for undergoing 2 days of training once they had recruited six participants and then £30 for the initial assessment of each participant and £10 for each consultation after the initial assessment.

The total cost of delivering the My Choice Weight Management Programme was £50,200. Total costs were higher among GP providers (£26,970) than among pharmacy providers (£23,230). This difference can be explained by the remuneration structure for the intervention, as payments were based on the number of sessions hosted (number of sessions hosted by GPs = 1735; pharmacy = 1447).

Costs per participant were higher through pharmacies (£126.90) than through GPs (£100.60). This was true throughout the course of the intervention, but the gap in costs between pharmacy and GP providers narrowed and there was no statistically significant difference in costs between providers among participants attending the final session. Again, the difference in costs is a result of the larger number of participants recruited by GPs. It is important to note that the demographic and socioeconomic characteristics of the pharmacy and GP groups differed significantly: GP participants tended to be older than pharmacy participants and the ethnic composition of the two groups differed significantly.

The cost-effectiveness of the intervention is measured in terms of costs per kilogram weight loss and costs per 1% weight loss and ICER at session 12 and session 15. The differences between providers were statistically significant; among participants attending session 12, the cost per kilogram weight loss was £57.00, with costs being higher among pharmacy providers (£74.80) than among GP providers (£43.40). Among participants attending session 15 (final session), the opposite pattern was observed, with the costs of both measures being lower among pharmacy providers than among GP providers (although these differences were not statistically significant). At session 12 each extra kilogram weight loss per participant would cost £8.29 through pharmacy providers. Conversely, at session 15, each extra kilogram of weight loss per participant would cost £2.91 through GP providers. At the end of the intervention the ICER favoured the pharmacy.

Jolly et al. 66 evaluated the direct costs to the primary care trust of each programme and of sending out invitation letters from practices. These included the costs of the provider’s service and the cost of the searches in general practice, invitation letters and provision of call centre support. The cost of the call centre that co-ordinated the service as an average per person, based on the cost of staff employed over a 12-month period and the number of clients who used the service over this time period. Costs to the participants were not included, nor were any training costs for providers.

Assuming that participants randomised to the most successful intervention continued to have a BMI 1.3 kg/m² less throughout life, then the cost per life-year saved was approximately £77. These benefits are not discounted and are based on many assumptions. The authors conclude that commercial organisations provide a more effective service at lower cost than primary care providers (GPs and pharmacists). One-to-one primary care-based programmes, including pharmacy-based programmes, were ineffective and most costly to provide (both £112.73 per participant based on a pool of 70 participants each).

Differential effects by demographic or socioeconomic factors

Two studies recruited participants from areas with high levels of socioeconomic deprivation. 65,66 The mean IMD score of participants in the GP surgery and pharmacy arms of the Lighten Up trial66 was 32.2 and 35.1, respectively. The study authors report that the characteristics of the participants reflected the population of the primary care trust well, with 23.5% of the participants being in the bottom 10% of socioeconomic deprivation, which is similar to that for the primary care trust, and 13% of participants being from a minority ethnic group, which is slightly lower than the local prevalence of 18%. The mean IMD score of participants attending the My Choice Weight Management Programme65 at GP surgeries and pharmacies was 43.8 and 43.3, respectively. Higher IMD scores indicate higher deprivation.

The Lighten Up trial66 evaluated a range of weight loss programmes in community and primary care settings; participants who were lost to follow-up tended to be younger than those who were followed up, but they were similar in terms of BMI, sex, ethnicity and IMD score.

The same two weight loss studies reported examining demographic and/or socioeconomic characteristics as potential predictors of outcomes within intervention groups. 65,66 Bush65 compared a weight management programme set in pharmacies versus the same programme set in GP surgeries and reported there were no statistically significant relationships between age, sex, IMD quintile or ethnicity and percentage weight loss at session 12 within pharmacy or GP surgery participants. In a study of weight loss programmes in various community and primary care settings, sex had no effect on weight loss. 66

These two weight loss studies reported examining demographic and/or socioeconomic characteristics as potential predictors of outcomes between intervention groups. 65,66 In a study of weight loss programmes in various community and primary care settings there was no statistically significant interaction between sex and the type of weight loss programme. 66

Bush et al. 65 compared a weight management programme set in pharmacies versus the same programme set in GP practices. Female participants who followed a programme based in a GP practice lost a significantly larger proportion of their initial weight than those following a pharmacy-based programme, and participants aged 40–49 years lost a greater proportion of their initial weight at GP providers than at pharmacy providers.

A summary of the evidence for weight loss interventions is provided in Box 3.

BOX 3 - Summary of evidence for weight loss interventions

• Five studies evaluated the effectiveness of community pharmacy-based weight loss interventions. The types of interventions were heterogeneous and the evidence limited; therefore, meta-analysis was not carried out.

• None of the studies demonstrated a significant difference in favour of the pharmacy-based intervention compared with control for any anthropometric outcome.

• Two studies reported cost-effectiveness; the costs associated with primary care interventions were broadly similar in the two studies. Cost-effectiveness varied at different time points and was influenced by the number of participants recruited (which differed by primary care setting). Commercial organisations provided a more effective service at lower cost than primary care providers.

• Two studies recruited participants from areas with high levels of socioeconomic deprivation. In one study there was no difference in effectiveness by sex. In another study, where participants chose the intervention which varied by setting, there was variation in effectiveness by setting according to demographic characteristics (age and sex).

Objective 1: to assess the effectiveness of community pharmacy interventions on health and health behaviours in relation to alcohol misuse, smoking cessation and weight management

There was insufficient evidence for the effectiveness and cost-effectiveness of community pharmacy-based brief alcohol interventions. Evidence from two trials suggests lack of effectiveness. It is not clear whether or not the UK alcohol screening services or brief advice provided in the pharmacy setting reduces a patient’s consumption of alcohol over time. UK alcohol screening services demonstrate that the community pharmacy is an appropriate place to screen patients for alcohol misuse.

Twelve studies evaluated the effectiveness of community pharmacy-based smoking cessation interventions. Pharmacy-based smoking cessation interventions, including behavioural support and/or NRT, are effective and cost-effective in helping adults to stop smoking, particularly when compared with usual care; however, there was heterogeneity between the studies. Four smoking cessation studies reported cost-effectiveness analyses, but the methods differed and this made comparisons difficult. However, three UK pharmacy-based interventions appeared cost-effective, despite relatively low quit rates.

Five studies evaluated the effectiveness of community pharmacy-based weight-loss interventions and did not demonstrate significant between-group differences in weight. However, the majority of these studies were comparing a pharmacy-based intervention with another active intervention either within the pharmacy or in another setting. One UK RCT, Lighten Up, compared eight groups (Weight Watchers, Slimming World, Rosemary Conley, a NHS community-based group called Size Down, GP, pharmacy, participants’ own choice and an exercise-only control group). At 1 year, participants in only the Weight Watchers programme had significant weight loss compared with the control group and this intervention was associated with the highest attendance rate. Mean weight loss at 1 year was 0.8 kg (SD 4.7 kg) for primary care (GP and pharmacy) and 2.5 kg (SD 6.2 kg) for commercial programmes (Weight Watchers, Slimming World, Rosemary Conley). Two weight-loss trials reported on cost-effectiveness. The pharmacy-based arm of Lighten Up was not cost-effective compared with commercial programmes. Another study reported costs for two primary care-based weight-loss services (GP and pharmacy) and the costs were broadly similar to that of the pharmacy-based programme in the ‘Lighten Up’ trial.

Five studies evaluated multicomponent interventions (pharmacotherapy and lifestyle changes) compared with usual care in participants with comorbidities (diabetes mellitus, dyslipidaemia, hypertension). None of the studies demonstrated a significant improvement compared with control for anthropometric outcomes, but they did show significant improvement in the relevant primary outcomes of blood pressure, glycaemic control and lipids.

Objective 2: to explore if and how socioeconomic status, sex, ethnicity and age moderate the effect of these interventions

None of the studies examined the differential effects of any measure of SES. Three studies (one smoking cessation63 and two weight loss studies65,66) examined the differential effects of demographic variables. The smoking cessation study reported no differential effect by sex. One weight loss study reported no differential effect by sex. 66 The other weight loss study reported isolated statistically significant differences in weight loss between participants attending the intervention in pharmacies and GPs; for example, female participants attending a GP lost a larger proportion of their initial weight than females attending a pharmacy. 65 Similarly, participants aged 40–49 years lost a greater proportion of their initial weight at GP providers than at pharmacy providers.

The significance of these differences in terms of inequalities is unclear; participants chose the service they wanted to attend and the demographics of participants differed significantly between the two settings. Another smoking cessation study shows demographic and socioeconomic differences between participants who self-select treatment by setting. This evidence suggests that the people accessing pharmacies are different from those attending other settings for alcohol management, smoking cessation and weight loss.

Some studies examined demographic and/or socioeconomic factors at recruitment stage, as potential predictors of outcomes within group, and/or to explain differences in retention. Although these studies cannot inform if and how these interventions might impact on inequalities, they can help to inform how interventions can be targeted to improve access, success and retention. The UK alcohol service evaluations suggest that these types of services have the potential to reach those most in need.

Objective 3: to describe how the interventions included in this review have been organised, implemented and delivered

Few studies reported detailed information about the behaviour change strategies employed to deliver the interventions in order to enable more specific coding of the interventions. The most common behaviour change strategy used in the included interventions was the transtheoretical model (stages of change). The majority of included interventions were implemented within the political context of extending the pharmacists’ public health role. The overall poor descriptions of intervention content, mechanisms and procedures in most of the included papers limit the potential for knowledge implementation and replication of the interventions under review.

There was insufficient detailed information to examine any potential relationships between intervention effectiveness and behaviour change strategies, and whether or not any patterns existed between effective interventions and implementation components such as pharmacist training or resource intensity. The reporting of stakeholder involvement (consultation and collaboration) in the planning or during the delivery of the intervention was particularly poor (only reported in two studies). In terms of sustainability, a number of studies highlight that reimbursement is needed to the pharmacist for providing the intervention in order for it to be sustainable.

Strengths and limitations

In terms of the strengths and limitations of the included studies, a thorough and robust search of the literature was carried out to ensure that all types of community pharmacy-delivered alcohol, smoking and weight management interventions were captured. However, only 24 controlled studies were identified, of which 19 were RCTs. Most of the studies focused on smoking cessation interventions and there were only two interventions for alcohol misuse. No restriction was placed on the types of interventions included within the review; this meant that five included studies focused on disease states rather than health behaviours. These multicomponent interventions addressed a variety of lifestyle factors in adults receiving pharmacotherapy for comorbidities including type 2 diabetes mellitus, dyslipidaemia and hypertension. Evidence from these studies is specific to these subgroups of participants.

The purpose of this review was to evaluate the effectiveness of pharmacy-delivered interventions in three behaviour-related areas (alcohol, smoking and weight), which are each relevant for public health and have a clear evidence base for interventions outside pharmacy settings. Alcohol consumption and smoking cessation are both health behaviours (as well as outcomes), whereas obesity is an outcome, and intervention can target dietary or physical activity behaviours, or both. Therefore, the effectiveness of weight interventions cannot be directly compared with interventions to reduce alcohol consumption or for smoking cessation.

This review was primarily a review of effectiveness and not a review of economic evaluations. Any cost outcomes that were reported within the included studies were assessed; however, the methods of cost-effectiveness analyses differed between the included studies, making comparisons difficult. Some of the economic analyses modelled predicted costs of health care as well as observed costs. In addition, assumptions are made on modelling (such as weighing a certain amount less throughout life or how many people will relapse and start smoking again over the life course), which should be borne in mind when assessing the evidence.

Within the protocol it is reported that different types of interventions would not be combined within a meta-analysis. However, owing to the relatively small number of included RCTs and the mix of intervention types we felt that it was appropriate as a ‘first step’ to group together the smoking cessation studies that included behaviour support and/or NRT. The primary research objective was to assess the effectiveness of any type of intervention which is delivered and based within a community pharmacy setting. Therefore, by grouping all intervention types together in a meta-analysis, we can begin to assess the effectiveness of interventions based within the community pharmacy. There was, however, insufficient evidence to say which specific type of smoking cessation intervention is most effective.

In terms of the strengths and limitations of the included studies, two were pilot studies and, although they met the eligibility criteria, these types of studies are inherently different from full trials. Pilot studies do not aim to be sufficiently powered or to have the procedures fully developed, unlike full trials. Quality assessment might not reflect the inherent difference in aims between these types of study designs, and this should be borne in mind when comparing the evidence.

An area of ongoing debate among triallists is about the unit of randomisation in RCTs, that is whether or not it is more appropriate to randomise a cluster, in this case pharmacies, as opposed to randomising the individual pharmacy client. This is particularly relevant to behaviour change interventions within the pharmacy practice setting. Of the 19 included RCTs, 17 randomised individual pharmacy clients and only two randomised pharmacies. It could be argued that cluster RCT design more accurately reflects the real world and strengthens the external validity of a study, making the evidence more relevant.

In terms of intervention fidelity, we assessed whether or not the consistency of interventions was measured, whether or not the interventions were delivered as intended and if it was likely that contamination occurred. In the vast majority of included studies it was not possible to assess fidelity, as these measures were not reported. In studies in which participants using the same pharmacy were randomised to intervention or control groups, there is an increased risk of contamination. This was the case for many of the studies included in this review, yet, despite this, only two of the trials reported on the possibility of cross-contamination between intervention and control groups. Lack of reported information of intervention fidelity limited the review, in terms of assessing the strength of any causal relationships between intervention components and outcomes.

The review is strengthened by the attention paid to contextual factors including the organisation, implementation and delivery of interventions. Attention was paid to extracting information about pharmacist training, which will be particularly useful to policy-makers. Few studies reported detailed information about the behaviour change strategies employed to deliver the interventions, in order to enable more specific coding of the interventions; the Behaviour Change Wheel and intervention ladder approaches were therefore chosen to broadly describe the interventions. The overall poor descriptions in most of the included studies, of intervention content, mechanisms and procedures, limits the potential for knowledge implementation and replication of the interventions under review.

This review included only process evaluations that were included within the trial papers; we did not search for papers from the included studies that separately reported process evaluations. Many studies have also been done on processes outwith evaluations. A new search would be required to systematically capture all the evidence from trials that have published work on contextual findings around the organisation, implementation and delivery of pharmaceutical care service by community pharmacies. Therefore, we refer to process evaluations only to describe how the included interventions have been organised, implemented and delivered. Given the paucity of reported process data from the included interventions, it is important that future interventions clearly report contextual factors.

Conclusions

There is insufficient evidence to assess the effectiveness of pharmacy-based interventions for alcohol management; however, the evidence does show that community pharmacies can be appropriate places to screen patients for alcohol misuse. Pharmacy-based smoking cessation interventions, including behavioural support and/or NRT, are effective and cost-effective in stopping adults smoking, particularly when compared with usual care. Evidence suggests that pharmacy-based weight loss interventions are as effective as similar interventions in other primary care settings but not as effective or cost-effective as commercially provided weight management services in community settings. Very few studies explored if and how sociodemographic or socioeconomic variables moderated interventions effects. The information reported in the studies shed very little light on how best to organise, implement and deliver interventions in the pharmacy setting.

Implications for public health

Our review has found a relatively small international evidence base; more evidence is needed to assess the effectiveness of pharmacy-based interventions for alcohol and weight management. Nine studies were conducted in the UK,46,48–51,56,58,60,65,66,68 and so the study findings should be generalisable to the UK pharmacy context. Our review has demonstrated that pharmacy-based interventions are effective and cost-effective in helping adults to stop smoking. The review supports the commissioning of smoking cessation services in a community pharmacy setting.

The evidence shows a range of types of smoking cessation interventions that are feasible within community pharmacies, including behavioural support and/or NRT, but not which specific types of interventions and components are the most effective. A range of type of interventions in various different settings is required to suit different adults who want to manage their alcohol intake, stop smoking or lose weight. Evidence from this review suggests that pharmacy-based interventions for smoking cessation are suitable as part of a suite of interventions.

The review has shown that is feasible to recruit patients to an alcohol screening intervention within a community pharmacy setting, but there is insufficient evidence of the effectiveness of such screening and brief intervention and whether or not this reduces a patient’s alcohol consumption over time. What is not known, however, is the outcome for patients who are identified as hazardous/harmful drinkers within a community pharmacy and referred to other branches of health care (e.g. a GP or rehabilitation centre). Given the reach of the community pharmacy network, and that our review has shown it is feasible to recruit patients in this setting, it would be prudent to explore referral options for adults who screen positive for hazardous/harmful drinking.

There is a lack of evidence regarding the effect of pharmacy-based interventions on health inequalities. Very few studies targeted disadvantaged population groups; these types of studies can provide useful information about recruitment and retention of these high-risk groups. Given the potential reach of the community pharmacy network, more work is needed to ascertain how commissioning smoking cessation services may impact on inequalities in health. Inequalities in relation to interventions can result from both differential uptake of pharmaceutical services and differential effectiveness by demographic and SES.

This review concentrates on differential effectiveness by demographic and SES (and found little evidence reported) but acknowledges that inequalities in uptake are an equally important contribution to health inequalities. Pharmaceutical needs assessments80 include evaluation of the level of access to community pharmacies, the specific needs of individual localities and uptake of services compared with other regions, but not differential uptake. Evidence from weight management programmes based in community pharmacies shows that middle-aged women are more likely to join. A 2000 postal survey81 in a stratified random sample of 10,000 adults aged ≥ 35 years in North Staffordshire, UK, showed that female sex and older age were independently associated with collection of a prescription medicine. Female sex, younger age and higher social class were independently associated with over-the-counter purchase, while female sex and smoking were independently associated with seeking advice from the pharmacist.

Recruitment to pharmacy-based interventions may indicate possible differences in uptake of pharmaceutical services. There is some evidence of differences in recruitment to community pharmacy interventions according to sex. Across all the studies there was a majority of female participants recruited and this was the more pronounced within the weight loss studies. It is unclear how this might impact on the willingness of men to use weight loss services in pharmacies. More research is needed about whether or not access to community pharmacies, and uptake of their services, differs by sociodemographic and socioeconomic characteristics.

The authors are not aware of any other reviews which directly compare public health interventions across different primary or community health-care settings. This review attempts to do just that by including studies that compared a pharmacy-based intervention group with interventions based in other settings. However, only five of the included studies compared a pharmacy setting with another setting (two smoking cessation and three weight loss interventions). One smoking cessation study compared pharmacy with an outpatient setting and found no significant difference between groups for smoking cessation. Another smoking cessation study found that the NHS group-based service set in the community attracted fewer clients but was significantly more effective in stopping smoking at 12 months than the pharmacy-based service. Three weight loss studies compared different settings, GP, primary care units and pharmacy settings appeared to be of equal effectiveness, which was less than that of commercial services based in the community.

A direct comparison between public health interventions in different settings is difficult because of differences in the characteristics of the participants and the context in which the interventions are delivered. There are many other factors in addition to effectiveness that need to be considered, such as recruitment and attendance, which appear to be comparable between GP surgeries and pharmacies but better in community and commercial programmes. Current evidence shows that referral to commercial weight loss providers is more effective than GP surgery- and pharmacy-delivered interventions. In the choice arm of the Lighten Up trial,66 71 (71%) participants chose one of the commercial providers, 16 (16%) chose the Size Down programme, three (3%) chose general practice and 10 (10%) chose pharmacy provision. Women were more likely than men to choose one of the commercial providers [57 (81%) women, compared with 14 (47%) men]. Among those randomised, the rate of participants not taking up the invitation to attend was twice as high for pharmacy as for commercial providers and only the minimal contact control arm had lower uptake rate. In terms of programme attendance, pharmacy had the worst attendance records of all arms.

As well as possible differential uptake of pharmaceutical services by demographic and socioeconomic characteristics, there may be differential uptake relative to other community health-care settings such as primary care. If a distinct group of people is accessing pharmaceutical services who would not access services in other health-care settings even if effect sizes are smaller than in other settings, then public health interventions within community pharmacies need to be considered as an option within a suite of choices available for the general population that could positively impact on health inequalities at a population level. However, we found an absence of evidence in this regard.

There is insufficient evidence to examine the relationship between behaviour change strategies and effectiveness or evidence of consistent implementation factors or training components that underpin effective interventions. More information is needed about pharmacist training and the experience of those delivering the training, resources required and sustainability of pharmacy-based interventions.

Contextual factors are important when developing public health services in a community pharmacy environment. One such important consideration is the changing landscape of health-care services and the emphasis placed on expanding the role of community pharmacies. This has been acknowledged internationally: the WHO has described qualities of a future pharmacist82 – one of whom is a care-giver. Rather than using community pharmacies in their traditional role in dispensing and compounding medication, there are drivers in policy to extend the role of community pharmacists. This is also evident in the NHS, where the changing contract of community pharmacies is allowing pharmacists to become more involved in patient-focused health-care service delivery. Recently there have been campaigns to use community pharmacies to obtain certain health-care advice rather than other, perhaps more costly, primary care services. Clearly, how the contract for these services is structured is an important factor in how these services are implemented.

Another important factor in terms of service delivery is how patients perceive community pharmacies. Recent evidence from a qualitative study83 suggests that patients will not ‘trust’ pharmacies to deliver unfamiliar health-care services. Similarly, a systematic review undertaken by Eades et al. 84 showed that, despite the changing role of community pharmacies, most consumers did not expect a public health service by a pharmacist; they also had mixed views on a pharmacist’s ability to provide such services. The public’s perception of community pharmacies and the ability to provide public health services could be a significant barrier towards implementation unless strategies are put in place to promote this.

The role of community pharmacies differs across the world, with many pharmacies still solely used as a means of supplying medication. Although nine studies included in this review were UK based, there were studies set in a further 10 countries, inside and outside Europe. It is probable that the uptake of pharmacy services will be variable, based on consumers’ perceptions and experiences. The influences on people’s choice of community pharmacy versus GP surgery, self-management or commercial provider are likely to vary between countries where health care is delivered using different models. However, in view of the changing role of pharmacy, the concept of ‘pharmaceutical care’ has been introduced. Although this relates to the provision of drug therapy, it is associated with the outcomes of treating or preventing disease. This term is recognised internationally and used throughout the world by policy-makers relevant to health care.

Research recommendations

This review has prompted various suggestions for improvement, to contribute to a more useful and rigorous evidence base, which will enable the translation of research findings into effective public health approaches for managing alcohol, smoking and weight within the pharmacy setting.

• Surprisingly, a relatively large proportion of the research so far has been carried out in the UK, which contributes to its generalisability to the UK pharmacy setting. However, the overall quality of the 24 included studies suggests that more research is required to improve recruitment and retention of participants to pharmacy-based interventions.

• Only two studies evaluated the efficacy of pharmacy-based interventions in improving alcohol management. Evaluations of interventions are required in order to assess the effectiveness of pharmacy-based interventions for alcohol management.

• More research is needed about how an intervention may impact on inequalities in alcohol misuse, smoking and obesity; and how this impact will be measured, in terms of socioeconomic variables and ethnicity. None of the studies examined the effect of interventions across the SES gradient. In a few cases where studies examined the differential effects of demographic variables, the significance of these differences on health inequalities is unclear. Future studies will need to be sufficiently powered to detect small changes and to measure equity effects of these small changes at a population level.

• The implementation tool was useful in extracting descriptive data across a wide range of factors. However, it will need to be refined in the future, or a new tool developed, if it is to help gather more insight into why an intervention might or might not work. Other methods of review, such as a realist review, offer an alternative approach to synthesising information about implementation, and so any refinement or new tool might benefit from taking this approach into account. However, as one of the problems in our review, and in others that have assessed implementation, was the paucity of information in the primary studies about implementation factors. Therefore, we recommend that ‘implementation reporting’ guidelines be developed within public health so that this important information is included by researchers undertaking primary studies, in a more systematic way.

• This review identified little evidence about the reach of pharmacy-based interventions. Targeted intervention studies provide some evidence that adults accessing pharmacies are a distinct subgroup that may not access other primary care or commercial services. This evidence is derived from participants who self-selected the intervention and setting. More research is required on the reach of the pharmacy setting.

Contributions of authors

Tamara J Brown (post-doctoral research associate, public health nutrition) provided methodological input and was responsible for management of the data collection, analysis and interpretation and, together with Carolyn D Summerbell, led the drafting of the report.

Adam Todd (programme director and senior lecturer in pharmacy practice) provided methodological and conceptual input, data collection, analysis and interpretation, and contributed to the drafting of the report.

Claire L O’Malley (research assistant, public health nutrition) contributed to data collection and the drafting of the report.

Helen J Moore (post-doctoral research associate, public health nutrition) designed and conducted the searches, contributed to the data collection and contributed to the drafting of the report.

Andrew K Husband (dean of pharmacy) provided methodological and conceptual input and contributed to the drafting of the report.

Clare Bambra (professor, public health geography) provided methodological input and contributed to analysis and interpretation in regards to health inequalities, and contributed to the drafting of the report.

Adetayo Kasim (statistician) conducted the meta-analysis and contributed to the drafting of the report.

Falko F Sniehotta (professor of behaviour medicine and health psychology) provided methodological input and contributed to the interpretation in regard to behaviour change interventions and to the drafting of the report.

Liz Steed (lecturer in health psychology) contributed to developing the search strategy, data collection and the drafting of the report.

Carolyn D Summerbell (professor, public health nutrition) was responsible for overall co-ordination and project management. She provided methodological and conceptual input, data collection, analysis and interpretation and, together with Tamara J Brown, led the drafting of the report.

Publications

Brown T, Todd A, O’Malley C, Moore H, Husband A, Bambra C, et al. Community pharmacy interventions for public health priorities: a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions. The Wolfson Research Institute for Health and Wellbeing 2015 Research Colloquium, Durham 15 April 2015.

Brown T, Todd A, O’Malley C, Moore H, Husband A, Bambra C, et al. Community pharmacy interventions for public health priorities: a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions. 22nd European Congress on Obesity 2015, Prague, 6–9 May 2015.

Brown T, Todd A, O’Malley C, Moore H, Husband A, Bambra C, et al. Community pharmacy interventions for public health priorities: a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions. International Society of Behavioral Nutrition and Physical Activity 2015 Annual Meeting, Edinburgh, 3–6 June 2015, poster number 1227.

Brown TJ, Todd A, O’Malley C, Moore HJ, Husband AK, Bambra C, et al. Community pharmacy-delivered interventions for public health priorities: a systematic review of interventions for alcohol reduction, smoking cessation and weight management, including meta-analysis for smoking cessation. BMJ Open 2016;6:e009828.

Data sharing statement

All data from this project can be acquired from the corresponding author.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health.

MEDLINE (via Ovid)

Searched: May 2014.

Date of search: from inception to May 2014.

Project details

Author.

Year.

Project name.

Publication type.

Journal Volume (Issue) Pages.

Aims (rationale, theory or goal of the elements essential to the intervention).

Target population(s).

Country.

Intervention description (materials used and procedures).

Start date of project.

End date of project.

Date.

Reviewers initials of data extraction.

Cost to participant, pharmacy, local authority, or other organisation(s).

Throughput – number of participants per time period.

Resources (time, money, staff and equipment).

Theoretical basis/behaviour change techniques used.

Contact details.

Language.

Behaviour-change wheel.

Intervention function.

Behaviour-change wheel.

Policy category.

Nuffield Intervention Ladder code.

Staff training and quality assurance.

Was consistency of intervention measured?

Was the intervention delivered as intended?

Is it likely contamination occurred?

Delivery fidelity

Experience of intervention team.

Project details notes (if required).

Implementation context notes.

Study information

Study Focus.

Smoking/Alcohol Study: Measure of behaviour?

Weight Study: Measure of weight? If no, stop extraction. If yes, add details on measures taken and instruments used (including if validated). If no, stop extraction. If yes, add details on measures taken and instruments used (including if validated).

Setting (should be community pharmacy).

Study Design Type RCT: allocated to different groups using methods that are random.

nRCT: allocated to different groups using methods that are not random.

CBA: observations are made before and after an intervention, both in a group that receives the intervention and in a control group that does not.

Interrupted time series (ITS): observations are made at multiple time points before and after an intervention.

RMS: a ITS study where measurements are made in the same individuals at each time point.

Before–After: must have at least 1 measure before and after (stop extraction, and keep in a pile).

Level of intervention (individual, community, societal).

Approach to targeting inequality (targeted or universal?).

Unit of randomisation/allocation.

Unit of analysis.

Did the intervention deliverers receive any training related to the intervention, and if so, what?

Measure of inequality.

Sex, age, and individual or area-level measures of socioeconomic status (education, income, occupation, social class, deprivation, poverty).

Population details

Population targeted.

Method of sampling (volunteer, random, stratified, etc.).

Ethnicity.

Study design.

Total population (number who could take part/approached).

Time between baseline and follow-ups.

Confounding from attrition/non response explored?

Adjustments?

Intention-to-treat?

Imputation of missing data?

Population details notes (if required).

% female (baseline sample).

Mean age (years) SD Median age (years) range.

Baseline recruitment rate (%).

Baseline sample size.

Final sample size.

Follow-up response rate (%) Sample size of final analysis.

If data are reported in two groups:

If data are reported together:

% female (baseline sample).

Mean age (years) SD Median age (years) range.

Baseline recruitment rate (%).

Baseline sample size.

Final sample size.

Follow-up response rate (%) Sample size of final analysis.

Intervention/Group 1:

% female (baseline sample).

Mean age (years) SD Median age (years) range.

Baseline recruitment rate (%).

Baseline sample size.

Final sample size.

Follow-up response rate (%) Sample size of final analysis.

Control/Group 2:

Outcomes and results

Data collection methods.

Outcomes.

Outcome assessor(s) aware of intervention status?

Participants aware of research question?

Data collection tools valid?

Data collection tools reliable?

Results (evidence of effectiveness).

Acceptability to staff and customers.

Evidence of cost-effectiveness (where applicable).

Set up and running costs.

Funding source and length/security of funding.

Outcomes and results notes (if required).

Stakeholder support.

Sustainability.

Implementation

A) Motivation (Why was the intervention implemented?).

B) Theoretical basis/behaviour change techniques used and staff training and quality assurance.

C) Implementation context Notes.

D) Experience of intervention team (planners/implementers).

E) Consultation and/or collaboration processes.

F) Was the intervention delivered as intended?

G) Sustainability.

H) Stakeholder support.

I) Resources (time, money, staff and equipment).

J) Differential effects.

Implementation score.

Component ratings

Global rating