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Jech 2021 216581
Jech 2021 216581
Jech 2021 216581
Study design
© Author(s) (or their INTRODUCTION In order to evaluate the effectiveness of preventive
employer(s)) 2022. Re-use
permitted under CC BY-NC. No Early detection and treatment of risk factors for health checks in a real-world setting on health and
commercial re-use. See rights chronic diseases such as cardiovascular diseases social outcomes, a pragmatic randomised controlled
and permissions. Published (CVDs) and diabetes mellitus have been found to trial (the CHPP core trial)9 was conducted in the
by BMJ. lower the risk of disease development and compli- municipality of Randers, Denmark (95 756 inhabi-
To cite: Bjerregaard A-L, cations.1 Preventive health examinations so-called tants on 1 January 2012 (Statistics Denmark, www.
Dalsgaard E-M, Bruun N-H, ‘health checks’ are such an early detection approach. dst.
dk)). All citizens aged 30–49 year, living in
et al. J Epidemiol Community However, the value of health checks is debated.2–7 the municipality on 1 January 2012, were invited
Health 2022;76:24–31. However, evidence from large pragmatic trials to a health check at the local healthcare centre.
24 Bjerregaard A-L, et al. J Epidemiol Community Health 2022;76:24–31. doi:10.1136/jech-2021-216581
Original research
Figure 1 Flow chart of the check your health prevention programme study population. GP, general practitioner. *Terminal illness, n<5.
Subsequently, they were offered tailored health interventions the population invited to attend in year 5 (N=5255) (invitation
based on their risk profile. The study design and setup have been period: from 6 April 2017 to 15 October 2018)9 (figure 1).
described thoroughly in the trial protocol.9
Setting
Randomisation The study was performed as an integrated part of the routine
The randomisation process is described in detail in the trial healthcare service,9 which in Denmark is based on a tax-funded
protocol.9 To avoid contamination from cohabitants, the study system, with the responsibility shared between local and regional
randomised households. Cluster randomisation of invitation health authorities. The primary entry point into the healthcare
sequence (year 1–5) was performed on 1 January 2012 at the system is through general practitioners. Prior to the study health
household level using information on residency obtained from professionals at the healthcare centre received training in the
the Danish Civil Registry. Randomisation was further balanced measurement procedures as well as in health promotion and risk
at the general practice level (N=38 general practices) to ensure communication.9 The general practitioners also received training
an even workload over the 5-year programme. In total, 26 216 including introduction to the CHPP, shared decision-making, PA
citizens (99.8% of the entire age group living in Randers munic- promotion and the risk stratification algorithm. Health checks
ipality) were assigned a randomised invitation sequence for the took place at the municipal-led healthcare centre in Randers.
CHPP (approximately 5200/year).
Intervention
Participants The intervention included four core components: (1) an invi-
A predefined subset of 10 505 citizens was selected for the CHPP tation sent from general practice, (2) a health examination and
trial analyses. The Intervention group (IG) was defined as the a questionnaire, (3) a personalised health profile summary and
population invited to attend the health check in year 2 (invita- (4) a risk-stratified follow-up at the healthcare centre or at the
tion period: from 2 July 2013 to 21 October 2014) and reinvited participant’s own general practitioner, if needed. The interven-
in year 5 (N=5250) (invitation period: from 6 April 2017 to 15 tion, including the preventive health checks, has been described
October 2018), and the comparison group (CG) was defined as in detail previously.9
Bjerregaard A-L, et al. J Epidemiol Community Health 2022;76:24–31. doi:10.1136/jech-2021-216581 25
Original research
Invitation complied with the Helsinki declaration and citizens provided
Invitations were sent out in collaboration with the local health- written informed consent to use their data for research purposes.
care centre in Randers and the citizens’ own general practitioner. The Danish Data Protection Agency approved the storage of the
The mailed invitations included an invitation letter, an informa- data at the Department of Public Health, Aarhus University.9
tion letter regarding access to the web-based questionnaire and
a prebooked date and time for the health examination. People Outcome measures
living together were offered an examination on the same date. Outcome measures at clinical, behavioural and functional level
were chosen to reflect different aspects and risk of chronic
Health examinations disease development.
The health examinations included anthropometric measures
(height, weight, waist circumference, BMI), blood samples
(glycated haemoglobin A1c (HbA1c), total cholesterol, low- CVD risk
density lipoprotein cholesterol), systolic and diastolic blood CVD risk was assessed based on the European HeartSCORE
pressures, lung function measurements and a submaximal bicycle 10-year-risk of a fatal cardiovascular event. The score is based
test. Participants completed a web-based questionnaire including on information on age, sex, smoking status, systolic blood pres-
questions on PA level, smoking habits, alcohol use and alcohol sure and total cholesterol15 and was analysed as a continuous
risk behaviour using the Alcohol Use Disorders Identification measure.
Test (AUDIT) (eg, binge drinking and other preliminary signs of
hazardous drinking and mild dependence), self-reported health Physical activity
and self-reported mental health. Self-reported PA was assessed by questionnaire. Information on
the number of days/week (range 0–7 days/week) with a minimum
Health profile summary of 30 min of moderate intensity PA was obtained. Cardiorespi-
Results from the health examination were explained to partici- ratory fitness (mL O2/kg/min) was estimated using Aastrand’s
pants immediately after the health examinations and they were submaximal cycle test.16
given recommendations for follow-up.9 Results were sent elec-
tronically to participant’s general practitioner. Self-rated health
Self-rated health was measured using the Short-form 12 (SF-
Risk-stratified intervention 12).17 Self-rated health was assessed from the first question (‘In
Referral to tailored healthcare interventions was based on the general, would you say your health is: excellent, very good,
individual participant’s health profile. The stratification algo- good, fair or poor’), dichotomised to 1=excellent, very good
rithm has been published previously.9 It stratifies risk of devel- and good and 0=fair and poor. Mental health was assessed by
oping chronic disease based on total cholesterol, blood pressure, the Mental Component Score from the SF-12, ranging from 0
HeartSCORE, HbA1c, lung function, waist circumference, BMI, to 100.
self-reported health, alcohol consumption, smoking status and
fitness level. Participants with low risk of disease development
Functional capacity
were encouraged to maintain their healthy lifestyle. Partici-
Functional capacity, including sick leave and affiliation to the
pants at moderate risk of developing disease (eg, with low PA
labour market, was assessed based on the national register of
levels, current smokers, high waist circumference or high BMI)
social transfer payments (the Danish Register for Evaluation of
were offered follow-up at the healthcare centre. Interventions
Marginalization, DREAM).18 Work participation was described
consisted of health promotion programmes addressing weight,
as an average monthly fraction of full-time employment during
diet, alcohol, PA, smoking and mental health or disease-specific
the last year before the invitation date and was analysed as a
self-management programmes (online supplemental table S1).
continuous measure. Sick leave was reported as numbers of sick-
Finally, participants at high risk of disease development were
leave periods of at least 3 weeks during the last year before invi-
recommended to make an appointment with their general
tation date.
practitioner.
Table 1 Characteristics of intervention and comparison group in the ‘check your health preventive programme’ at the time of randomisation
(January 2012)
Characteristics Intervention group Comparison group Total P value
Total population, n (%) 5250 (50.0) 5255 (50.0) 10 505 (100.0)
Sex
Women, n (%) 2565 (48.9) 2581 (49.1) 5146 (49.0)
Men, n (%) 2685 (51.1) 2673 (50.9) 5358 (51.0) 0.78
Age at randomisation (years)
Age, mean (SD) 40.6 (5.6) 40.5 (5.6) 40.5 (5.6) 0.25
Age groups, n (%)
30, n (%) 1093 (20.8) 1129 (21.5) 2222 (21.2)
35-, n (%) 1316 (25.1) 1351 (25.7) 2667 (25.4)
40, n (%) 1340 (25.5) 1334 (25.4) 2674 (25.5)
45, n (%) 1501 (28.6) 1440 (27.4) 2941 (28.0) 0.51
Nationality
Danish, n (%) 4872 (92.8) 4849 (92.3) 9721 (92.6)
Immigrants or descendants, n (%) 376 (7.2) 404 (7.7) 780 (7.4) 0.30
Living alone
No, n (%) 4218 (80.3) 4201 (80.0) 8419 (80.2)
Yes, n (%) 1032 (19.7) 1053 (20.0) 2085 (19.8) 0.62
Educational attainment
<10 years, n (%) 1061 (20.6) 1051 (20.4) 2112 (20.5)
10–15 years, n (%) 2549 (49.4) 2603 (50.4) 5152 (49.9)
≥15 years, n (%) 1549 (30.0) 1507 (29.2) 3056 (29.6) 0.55
Income level
Low, n (%) 1738 (33.3) 1750 (33.4) 3488 (33.3)
Middle, n (%) 1712 (32.8) 1773 (33.9) 3485 (33.3)
High, n (%) 1775 (34.0) 1711 (32.7) 3486 (33.3) 0.32
Income (1000 DKK), mean (SD) 233.9 (108.8) 233.2 (100.8) 233.6 (104.9) 0.71
Occupational status
Employed, n (%) 4085 (77.8) 4032 (76.8) 8117 (77.3)
Self-employed, n (%) 225 (4.3) 249 (4.7) 474 (4.5)
Unemployed/benefits, n (%) 232 (4.4) 239 (4.6) 471 (4.5)
Social welfare recipients, n (%) 599 (11.4) 610 (11.6) 1209 (11.5)
Others, n (%) 107 (2.0) 121 (2.3) 228 (2.2) 0.62
challenges. The unique collaboration, taking its point of depar- missing outcomes. Hence, we used MI and propensity score
ture in the existing healthcare system, involved the local health- methods to minimise biased effect estimates. Our extensive
care centre, local and regional authorities, the citizens’ own GP, model control did not give rise to validity concerns as our
the local environment in general and the university. Together the supplementary analyses provided almost identical results.
stakeholders ensured that the implementation of the preventive Still, some limitations exist: first, we cannot rule out the
health check programme was practically and financially feasible impact of effect dilution. Even though citizens living together
and acceptable to the population. This setup ensured that, had were randomised and invited to participate at the same time,
the programme demonstrated added effectiveness, it would be in order to avoid contamination, the CHPP was a real-world
sustainably to implement. Even though the study had null find- study carried out in a local setting. As such, the municipal focus
ings, the efforts and lessons learnt during this implementation (eg, media and political coverage) regarding the CHPP could
provided the local environment with important experience on have raised the awareness of the citizens allocated to the control
how to conduct health promotion interventions in a sustainable group to focus on their health. The tendency that citizens with
way. Furthermore, the unique collaborative approach may have a healthier and socioeconomically advantaged profile were
led to an unmeasured increased political and strategic focus more likely to participate in the programme (as compared with
on promoting a healthy lifestyle—from municipal politicians, disadvantaged citizens), which also might have induced a dilu-
opinion formers and from the local society in general. This tion of the effect. Second, the actual dose of stratified health
dimension is subjected for further research. intervention delivered in CHPP is unknown, since we did not
As seen in other studies evaluating preventive health have data on participation in the health promotion programmes
checks,10 22 23 the CHPP had low participation and large dropout. at the Randers Health Care Centre. Indeed, information from
Consequently, we could not perform the planned intention-to- the national registers showed that there was a small increase in
treat analysis on health outcomes9 in a nonbiased way, due to number of consultations at the general practitioners following
28 Bjerregaard A-L, et al. J Epidemiol Community Health 2022;76:24–31. doi:10.1136/jech-2021-216581
Original research
the health check, as compared with the period before the health Discussion of findings
check. However, the actual content of these extra consulta- Despite the young age group in the CHPP, the behavioural char-
tions is unknown. A recent Danish study evaluating the effect acteristics of the study population pointed towards a popula-
of preventive health checks in high-risk groups found that only tion that could benefit from health promotion initiatives at an
a low proportion of high- risk participants was visiting their early stage. In general, participants did not fulfil the PA guide-
general practitioner following a health check,24 and that general lines from the Danish Health Authorities (minimum of 30 min of
practitioners had several barriers towards referral to municipal
moderate intensity PA everyday), and maximal oxygen consump-
behaviour change programmes.24 Third, although performed in
tion was low to very low. Furthermore, the proportion of over-
a real-world setting, the CHPP was designed as a health promo-
weight (39%) or obese (23%) citizens, and the proportion of
tion intervention with focus on the individual level. Indeed,
the CHPP had local media coverage; however, there were no daily smokers (19%), left considerable room for improvement
formalised efforts to decrease disease risk at the local structural with regards to promoting a healthy lifestyle. The low CVD risk,
level or by explicitly targeting interindividual social connections. as expressed by HeartSCORE, was most likely due to the low age
As such, the impact of providing multifaceted health promotion of participants. However, even when extrapolated to the age of
activities integrated in the socioecological environment remains 60 years, the mean HeartSCORE was rather low (2.0%). When
to be examined. looking at the individual clinical risk factors of the IG at the time