To evaluate clinical and cost outcomes of multifactorial comprehensive cardiovascular risk management programmes in worksites.

Electronic searches of MEDLINE, and manual searches of specific journals, were conducted in order to identify relevant articles published in peer-reviewed journals. The reference lists of the retrieved articles were examined and direct enquiries were made to worksite health promotion experts.

Study designs of evaluations included in the review

Randomised controlled trials (RCTs) of 'properly conducted studies with comparison group' of worksite, multifactorial cardiovascular risk management programmes were included if they incorporated an evaluation of the programme. The duration of the follow-up ranged from 3 months to 12 years. The unit of randomisation included employees and work sites. The following intervention groups were compared in the primary studies:

participants and non-participants;

participants and a newly constituted group of non-participants;

high-risk participants and non-participants;

early and delayed intervention sites; and

the change across sites at different levels of intervention.

Anecdotal and purely descriptive studies were excluded. Studies investigating only a single cardiovascular risk factor were briefly noted.

Specific interventions included in the review

Comprehensive worksite-based health promotion and disease prevention programmes. The programmes were defined as 'those programmes that provide an ongoing, integrated, programme of health promotion and disease prevention that integrates particular components into an ongoing coherent programme that is consistent with corporate objectives and includes programme evaluation'. All programmes reviewed included an initial medical screening and health risk assessment as the initial step. Combinations of the following interventions were included:

educational interventions on diet, smoking, and exercise;

personal counselling to high-risk groups;

individual goal setting;

group exercises;

skills-based risk reduction modules;

environmental modifications;

provision of education classes, awareness-enhancing materials and classes, wellness counsellors, self-help materials, workshops, seminars, health news letter, resource centre, self-care book, and fitness facilities on-site;

on-site smoking cessation and weight loss programme combined with incentive system through payroll deduction;

tuition reimbursement for participation in community programmes;

employee steering committees tailoring health promotion activities to the worksite;

choice from a menu of motivational, educational, policy and maintenance interventions;

'menu' of interventions;

strategies to enhance social support;

follow-up and case management of those at risk;

environmental policy changes;

behaviour counselling;

behaviour changing incentives; and

treatment of hypertension.

The counselling was conducted by personnel including physicians and nurses.

Participants included in the review

The participants were employees in factories, manufacturing plants, metropolitan school districts, government organisations, federal agencies, utility companies, and the ambulance service. Both men and women were included. Employees included in the evaluation were at high risk or were randomly selected from the workforce.

Outcomes assessed in the review

The clinical and/or cost impact of the programmes were assessed. Information on the cost-effectiveness, cost-savings, and cost-benefits analysis were sought. The following clinical outcomes were reported in the individual studies:

smoking, including self-reported smoking;

systolic blood-pressure;

plasma cholesterol;

weight;

overall coronary heart disease mortality and morbidity;

physiological measures of fitness;

self-reported measures of health and well-being;

absenteeism, including self-reported absenteeism;

health attitudes;

alcohol use;

self-reported health behaviours;

dietary fat intake; and

aerobic capacity.

How were decisions on the relevance of primary studies made?

The author does not state how the papers were selected for the review, or how many of the reviewers performed the selection.

The author does not state that walidity was formally assessed, although aspects of validity were mentioned.

The author does not state how the data were extracted for the review, or how many of the reviewers performed the data extraction.

How were the studies combined?

The studies were combined in a narrative review.

How were differences between studies investigated?

The individual studies were described along with their methodological flaws.

Twelve RCTs (42,95 employees evaluated) were included. [N estimated using Kornitzer study on basis of: if 84% = 19,409, then 71% = 11,576].

The studies were highly heterogeneous in design methodology and statistical analysis. Eight of the 12 included studies used the worksite both as the unit of assignment and analysis. None of these 8 studies analysed cost-effectiveness outcomes.

The majority of the research to date suggest the following:

clinical and cost outcomes are favourable;

more relevant and more rigorously-designed research tends to support rather than refute earlier and less rigorously-designed studies;

one may consider the methodological flaws and diversity as indicative of a robust phenomenon evident in many types of worksites with diverse employees, differing interventions, and varying degrees of methodological sophistication. The unit costs of mail-based recruitment in the general population to smoking cessation and weight-loss programmes ranged from $11 (weight loss) to $62 (smoking). These studies were not included in the review.

No costs were reported from the studies included in the review.

The costs were reported for a programme focusing on weight reduction and smoking cessation as cardiovascular risks. The costs of each person who stopped smoking were $100 to $200.

Despite the many limitations of the current methodologies of the included studies, the majority of research indicates that favourable clinical and cost outcomes can result from worksite interventions. In addition, providing opportunities for individualised cardiovascular risk reduction, and counselling high-risk employees, may be the critical components of an effective worksite intervention. The results from the studies reviewed provided both cautious optimism about the effectiveness of these worksite programmes, and insights into the essential components and characteristics of successful programmes.

Certain characteristics of the primary studies were tabulated clearly. The description of the individual studies and the discussion included some of the following methodological flaws: most studies used the individual employee as the unit of analysis even when the unit of randomisation was the worksite; the definition of participation was variable; the denominators for effect estimates and cost-effectiveness varied widely; there was a lack of consideration of intraclass correlation due to employees working in the same worksite; there was difficulty in differentiating intervention effects from other variables such as secular trends, state or local health policy changes, and changes in medical benefit plans; there was a potential confounding effect of self-selection for participation in programmes, and differential response rates among social class or ethnic groups; the participation rates of high- and low-risk employees were generally not distinguished; and there was a lack of reporting the differential attrition rates across risk categories. The author pointed out that the interventions used were intensive, hence expensive. In addition, they may be difficult to replicate, and thus have limited generalisability.

Details of the journals searched manually and the keywords used were lacking. By limiting the search to published studies, some relevant studies may have been omitted. No mention was made of the methods used to select the studies for inclusion or to extract the data. Some aspects of study validity were mentioned but no formal assessment was reported. The results of individual studies were not quoted, the comparability of treatment groups within the trials was not assessed, and no costing details were given for those studies included in the review. Details given of the groups compared suggested that some studies did not use comparable groups to evaluate the intervention. However, the comparability of treatment groups within trials was not assessed. A narrative review was the most suitable method of synthesising the data given the heterogeneity among studies.

The results of this review were limited by the heterogeneity of various aspects among the primary studies, the methodological flaws discussed by the author, the lack of a validity assessment, and the absence of an economic analysis from those studies in which the worksite was both the unit of randomisation and analysis.

The author considered that future research should include the following: an evaluation of the various components or combinations of components of multifactorial interventions, including public health approaches, individualised behavioural counselling, and interventions with different intensities; an investigation of effects over time; an evaluation of the potential impact on medical care costs; use of the worksite as the unit of randomisation and analysis; studies with a duration of at least 3 to 5 years; standardisation of what constitutes either costs or benefits and their evaluation; separate analyses for strategies aimed at high- and low-risk groups; explicit objectives and outcomes for each programme; and inclusion of a qualitative evaluation from the perspective of the employee.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.