| Literature DB >> 35127352 |
Anke Bruninx1, Bart Scheenstra2,3, Andre Dekker1, Jos Maessen2,3, Arnoud van 't Hof3,4,5, Bas Kietselaer3,4,5, Iñigo Bermejo1.
Abstract
This study aimed to systematically review the use of clinical prediction models (CPMs) in personalised lifestyle interventions for the prevention of cardiovascular disease. We searched PubMed and PsycInfo for articles describing relevant studies published up to August 1, 2021. These were supplemented with items retrieved via screening references of citations and cited by references. In total, 32 studies were included. Nineteen different CPMs were used to guide the intervention. Most frequently, a version of the Framingham risk score was used. The CPM was used to inform the intensity of the intervention in five studies (16 %), and the intervention's type in 31 studies (97 %). The CPM was supplemented with relative risk estimates for additional risk factors in three studies (9 %), and relative risk estimates for intervention effects in four (13 %). In addition to the estimated risk, the personalisation was determined using criteria based on univariable risk factors in 18 studies (56 %), a lifestyle score in three (9 %), and a physical examination index in one (3 %). We noted insufficient detail in reporting regarding the CPM's use in 20 studies (63 %). In 15 studies (47 %), the primary outcome was a CPM estimate. A statistically significant effect favouring the intervention to the comparator arm was reported in four out of eight analyses (50 %), and a statistically significant improvement compared to baseline in five out of seven analyses (71 %). Due to the design of the included studies, the effect of the use of CPMs is still unclear. Therefore, we see a need for future research.Entities:
Keywords: Behavioral medicine; Cardiovascular diseases/prevention and control; Decision support techniques; Models, cardiovascular; Patient-specific modeling
Year: 2021 PMID: 35127352 PMCID: PMC8800044 DOI: 10.1016/j.pmedr.2021.101672
Source DB: PubMed Journal: Prev Med Rep ISSN: 2211-3355
Fig. 1PRISMA flow-diagram.
Synthesis: study name (if any), citation, region, study design, participants, intervention and comparator (if RCT), CPM, supplement, and use of CPM, primary outcome(s).
| British FHS | ( | UK | RCT | n = 12 472 Primary care Males 40 – 59 years and their spouses | Risk assessment and communication, lifestyle counselling concerning smoking, physical activity, nutrition, and / or alcohol intake, diary, brochures, frequency of follow-up according to degree of risk, referrals, medications possible via referral TAU, same practice and matched practice | British FHS risk score ( Supplemented with univariable risk factors Suggested action: determine intervention intensity | Length of follow-up: 1 year CPM estimate, biomarkers (blood pressure, lipids, other: glucose), anthropometrics, lifestyle (smoking) All outcomes, except glucose and lipids in female group, statistically significant differences in favour of the intervention; concerning glucose and lipids in female group, no statistically significant differences | |
| – | ( | FI | RCT | n = 150 Primary care 18 – 65 years Inclusion based on CVD risk | Personal health plan according to risk, lifestyle changes concerning physical activity, and / or nutrition, medications, two scheduled follow-up moments between baseline and end-point with doctor and nurse TAU, brochure | North Karelia risk score (modified) ( Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 2 years CPM estimate No statistically significant difference | |
| – | ( | USA | RCT | n = 154 Primary care ≥ 45 years Inclusion based on CVD risk Exclusion based on CVD | Risk assessment and communication, personal health plan: education, individual and group counselling concerning smoking, physical activity, nutrition, psychological well-being, and / or other (e.g., communication skills) TAU, risk assessment and communication | Know your number ( Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 10 months CPM estimate Statistically significant steeper improvement in favour of the intervention | |
| Hartslag Limburg | ( | NL | RCT | n = 1 300 Primary care Inclusion based on CVD risk | Optimisation of medical treatment and health counselling concerning smoking, physical activity, nutrition, and / or medication adherence, referrals TAU | Coronary risk charts ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1.5 years Not specified | |
| Simon Fraser heart health report card system | ( | CA | RCT | n = 611 General population 45 – 64 years Inclusion based on CVD risk | Report card sent to participant and participant’s GP, telehealth counselling concerning smoking, physical activity, nutrition, and / or psychological well-being, educational materials TAU | FRS Wilson ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year CPM estimate Statistically significant difference in favour of the intervention in the primary prevention group, not in the secondary prevention group | |
| ARRIBA-Herz | ( | DE | RCT | n = 1 132 Primary care | Decision-aid, personal health plan concerning smoking, physical activity, nutrition, and / or medications, training sessions for physicians TAU, unrelated training sessions for physicians | ARRIBA-Herz ( Supplemented with relative risk estimates concerning additional risk factors and intervention effects Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 6 months CPM estimate, other (patient activation, decisional regret) No statistically significant difference CPM estimates, statistically significant improved patient activation (patient’s participation / satisfaction) and less decisional regret in favour of the intervention | |
| Inter99 study | ( | DK | RCT | n = 59 616 General population Near age 30, 35, 40, 45, 50, 55, 60 years Inclusion based on CVD risk | High intensity condition: risk assessment and communication, individual counselling concerning smoking, physical activity, nutrition, and / or alcohol intake, brochures, group-based counselling for high risk participants concerning smoking, physical activity, and / or nutrition; low intensity condition: risk assessment and communication, individual counselling concerning smoking, physical activity, nutrition, and / or alcohol intake, brochures, referrals, medications possible via referral ( TAU | Copenhagen risk score ( Supplemented with univariable risk factors Suggested action: determine intervention type | Length of follow-up: 10 years Mortality / morbidity (composite fatal / non-fatal IHD) No statistically significant differences comparing intervention and comparator condition | |
| Healthy hearts | ( | UK | Single-arm study | n = 596 Primary care 45 – 64 years Exclusion based on CVD | Risk assessment and communication, advice, personal risk mitigation via referrals concerning primary care, smoking, physical activity, and / or nutrition, medications possible via referral | FRS Anderson ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year CPM estimate Statistically significant improvement from baseline | |
| REACH OUT | ( | EU | RCT | n = 1 103 Primary care 45 – 64 years Inclusion based on CVD risk Exclusion based on CVD | Risk assessment and communication, personal health plan concerning smoking, physical activity, nutrition, and / or medication adherence, medications, three follow-ups by phone, training for physicians ( TAU | FRS ATP III ( Supplemented with univariable risk factors Suggested action: determine intervention type | Length of follow-up: 6 months CPM estimate Statistically significant difference in favour of the intervention | |
| IMPALA | ( | NL | RCT | n = 615 Primary care Smoking and age ≥ 50 years for males, smoking and age ≥ 55 years for females (non-smokers at high risk without any age restriction were included as well) Inclusion based on CVD risk Exclusion based on CVD | Risk assessment and communication, decision-aid, adapted motivational interviewing by nurses concerning smoking, physical activity, nutrition, alcohol intake, and / or medication adherence, medications, training for nurses, referrals ( TAU, training for nurses (less extensive) | SCORE ( Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year Not specified | |
| COHRT | ( | CA | RCT | n = 680 General population 35 – 74 years Inclusion based on CVD risk | Risk assessment and communication to participant and participant’s GP, advice concerning smoking, physical activity, and / or nutrition, brochures, referrals to community programs Same as above plus one hour telehealth counselling concerning smoking, physical activity, and / or nutrition for 6 weeks | FRS Wilson ( Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 6 months Lifestyle (physical activity, nutrition) Statistically significant differences in favour of the intervention concerning physical activity and nutrition | |
| HAPPY / MyCLIC: NL | ( | NL | Single-arm study | n = 595 General population | Risk assessment and communication, lifestyle counselling via e-mail concerning smoking, physical activity, and nutrition, referrals, medications possible via referral | PROCAM ( Supplemented with lifestyle score Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 3 months Not specified | |
| Heart to heart | ( | USA | RCT | n = 160 40 – 79 years Internal medicine practice patients Inclusion based on CVD risk Exclusion based on CVD | Risk assessment and communication, decision-aid including selecting smoking cessation and / or medications to mitigate risk, three e-mails to enhance adherence, education session for physicians TAU | FRS Wilson ( Supplemented with relative risk estimates concerning intervention effects Suggested action: determine intervention type | Length of follow-up: 3 months Not specified | |
| Fremantle primary prevention study | ( | AU | RCT | n = 1 200 Primary care 40 – 80 years Exclusion based on CVD | Risk assessment and communication, five GP visits, including at baseline and at end of study, counselling concerning smoking, physical activity, and / or nutrition, medications, referrals TAU, GP visit at baseline and at end of study | New Zealand cardiovascular risk calculator ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year CPM estimate No statistically significant difference | |
| PreCardio | ( | BE | RCT | n = 314 Self-employed lawyers 25 – 75 years | Medical programme: risk assessment and communication concerning smoking, physical activity, nutrition, and / or medications, referrals Medical and lifestyle programme: same as above plus individual coaching concerning smoking, physical activity, and / or nutrition, website tailored to the participant’s profile | SCORE ( Supplemented with univariable risk factors Suggested action: determine intervention intensity, determine intervention type | Length of follow-up: 3 years Biomarkers (blood pressure, lipids), anthropometrics No statistically significant differences | |
| ANCHOR | ( | CA | Single-arm study | n = 1 509 Primary care ≥ 30 years Inclusion based on CVD risk (analysis) Exclusion based on CVD (analysis) | Risk assessment and communication, lifestyle counselling concerning smoking, physical activity, nutrition, psychological well-being, medication adherence, and / or other (focus on acquiring behavioural change skills), training for counsellors, referrals, medications possible via referral ( | FRS ATP III ( Suggested action: determine intervention intensity, determine intervention type Supplemented with univariable risk factors | Length of follow-up: 1 year CPM estimate Statistically significant improvement from baseline | |
| Heart to health | ( | USA | RCT | n = 385 Primary care 35 – 79 years Inclusion based on CVD risk Exclusion based on CVD | Decision-aid, selecting treatment options guided by risk estimates concerning smoking, physical activity, nutrition, and / or medications, medication adherence, seven counselling sessions via web, referrals Same as above but seven counselling sessions by health counsellor instead of via web | FRS Anderson ( Supplemented with relative risk estimates concerning intervention effects Suggested action: determine intervention type | Length of follow-up: 1 year CPM estimate Specification of within condition analyses at 4 months as primary outcomes, statistically significant improvement from baseline in both conditions | |
| My family medical history and me (pilot) | ( | USA | Single arm study (pilot) | n = 15 University students 18 – 25 years Inclusion based on CVD risk Exclusion based on CVD | Risk assessment and communication focused on family history of CVD, lifestyle advice concerning smoking, physical activity, and nutrition, brochures | FRS ATP III ( Supplemented with univariable risk factors Suggested action: determine intervention type | Length of follow-up: 2 weeks Not specified | |
| Protecting healthy hearts program / GARDIAN | ( | AU | Single-arm study | n = 530 Population living remotely from health services ≥ 18 years | Risk assessment and communication, depending on risk category one follow-up moment by phone and one or two follow-up moments in person, personal health plan concerning smoking, physical activity, nutrition, alcohol intake, psychological well-being, and / or medication adherence, brochures, referrals, medications possible via referral, training for diabetes educators / nurses ( | Absolute CVD risk score ( Supplemented with univariable risk factors Suggested action: determine intervention intensity, determine intervention type | Length of follow-up: 6 months Not specified | |
| – | ( | UK | Single-arm study | n = 635 Local governmental employees in deprived areas ≥ 40 years Exclusion based on CVD | Risk assessment and communication, possible referrals concerning smoking, physical activity, nutrition, alcohol intake, psychological well-being, and / or medications | National health services health check’s cardiovascular risk assessor ( Supplemented with univariable risk factors Suggested action: determine intervention type | Length of follow-up: 9 months Not specified | |
| IEHPS (pilot) | ( | CN | RCT (pilot) | n = 589 Healthcare employees 45 – 75 years Exclusion based on CVD | Risk assessment (including physical examination) and communication, counselling concerning smoking, physical activity, nutrition, alcohol intake, and / or psychological well-being, medications, educational handbook, follow-up phone calls and text messages TAU, physical examination | CPM for ICVD ( Supplemented with univariable risk factors, physical examination index Suggested action: determine intervention intensity, determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year CPM estimate Statistically significant difference between intervention and comparator in favour of intervention | |
| INTEGRATE (pilot) | ( | NL | Single-arm study (pilot) | n = 230 Primary care 45 – 70 years Exclusion based on CVD | Stepped risk assessment, risk communication, decision-aid, lifestyle advice via online tool concerning smoking, physical activity, nutrition, alcohol intake, and / or psychological well-being, medications, referrals | SCORE (modified) ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 6 months Not specified | |
| – | ( | FI | Single-arm study | n = 185 Males aged 40 years living in Helsinki Inclusion based on CVD risk (analysis) | Risk assessment and communication, lifestyle counselling, brochures concerning smoking, physical activity, and nutrition, referrals, medication possible via referral | North Karelia risk score (modified) ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 5 years CPM estimate, lifestyle (smoking, physical activity, nutrition) (stratification by follow-up care: none, primary care, occupational health care) Statistically significant improvements concerning one of two CPM estimates (non-significant: p = 0.060) (some statistically significant differences between follow-up care groups), statistically significant improvements concerning smoking, physical activity, and nutrition (no statistically significant differences between follow-up care groups) | |
| CHARLAR | ( | USA | Single-arm study | n = 1 099 Latin-Americans ≥ 45 years | Risk assessment and communication, 3 months prevention program concerning smoking, physical activity, nutrition, and other (e.g., goal setting), education, referrals, medications possible via referral | FRS PCE ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 3 months CPM estimate Statistically significant improvement from baseline | |
| DECADE | ( | DE | RCT (pilot) | n = 87 Primary care Inclusion based on CVD risk | Decision-aid, personal health plan concerning smoking, physical activity, and / or nutrition, medications, four follow-up sessions, brochures Same as above minus brochures | ARRIBA-Herz ( Supplemented with relative risk estimates concerning risk factors and intervention effects Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 4 months Other (patient activation) Statistically significant improvement in favour of the intervention | |
| ACTIVATE | ( | USA | RCT | n = 417 USA veterans Inclusion based on CVD risk | Online risk assessment and communication, two phone calls by health coach, referrals concerning smoking, physical activity, and / or nutrition Online risk assessment and communication | MyHealtheVet’s health age ( Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 6 months Other (patient activation) Statistically significant improvement in patient activation (enrolment in prevention program) in favour of the intervention | |
| HAPPY / MyCLIC: AZM | ( | NL | Single-arm study | n = 1 062 Healthcare employees Exclusion based on CVD | Risk assessment and communication, lifestyle counselling concerning smoking, physical activity, nutrition, alcohol intake, psychological well-being, and / or other (e.g., sleep) via online tool and e-mail | PROCAM ( Supplemented with a lifestyle score Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year Not specified | |
| HAPPY / MyCLIC: London | ( | UK | RCT | n = 402 Primary care 40 – 74 years Inclusion based on CVD risk Exclusion based on CVD | Risk / lifestyle assessment and communication, counselling by physician, lifestyle counselling concerning smoking, physical activity, nutrition, alcohol intake, psychological well-being, and / or other (e.g., sleep) via online tool, e-mail reminders TAU, counselling by physician | QRISK2 ( Supplemented with a lifestyle score Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 6 months Biomarkers (other: carotid-femoral pulse wave velocity) No statistically significant difference intervention and comparator | |
| – | ( | IN | Single-arm study | n = 402 Tertiary care ≥ 40 years Inclusion based on CVD risk Exclusion based on CVD | Risk assessment and communication, education and counselling concerning smoking, physical activity, nutrition, alcohol intake, and / or medication adherence by trained nurses, three follow-up phone calls ( | WHO / ISH ( Supplemented with univariable risk factors Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year CPM estimate Statistically significant improvements from baseline | |
| INTEGRATE | ( | NL | RCT | n = 1 934 Primary care 45 – 70 years Exclusion based on CVD | Stepped risk assessment, risk communication, lifestyle advice online or treatment by GP based on risk including addressing smoking, physical activity, and / or nutrition, medications, referrals ( TAU | CPM for CMD ( Supplemented with univariable risk factors Suggested action: determine intervention type | Length of follow-up: 1 year CPM estimate, biomarkers (blood pressure, lipids, other: glucose), anthropometrics, lifestyle (smoking), medications, other (CMD detection) Within intervention condition analyses: statistically significant improvement from baseline CPM estimate, only after adjustment for aging, statistically significant improvements concerning blood pressure and lipids, no statistically significant improvement concerning glucose, mixed results concerning anthropometrics (statistically significant improvement concerning waist circumference, not BMI), no statistically significant reduction in percentage of smokers from baseline; between conditions analyses: statistically significant increased detection CMD and more prescriptions of CMD medications in intervention condition | |
| CONNECT | ( | AU | RCT | n = 934 Primary care ≥ 18 years Inclusion based on CVD risk | Access to application with electronic health record connection displaying current diagnoses and medications, educational materials, risk calculator, lifestyle change support concerning smoking, physical activity, nutrition, psychological well-being, and / or medication adherence, medications possible via encouragement discussion with GP, social media, possibility to receive additional advice via e-mail and / or SMS, support service TAU | FRS Anderson ( Suggested action: determine intervention type Insufficient detail in reporting | Length of follow-up: 1 year Lifestyle (other: medication adherence) No statistically significant difference | |
| – | ( | USA | Single-arm study | n = 38 Weight management clinic patients ≥ 18 years Inclusion based on CVD risk | Access to application to track and improve nutrition | Healthy heart score ( Suggested action: determine intervention type | Length of follow-up: 5 weeks Not specified |
ACTIVATE = a coaching by telephone intervention for veterans and care team engagement; ANCHOR = a novel approach to cardiovascular health by optimizing risk management; ARRIBA-Herz = Aufgabe gemeinsam definieren, Risiko subjektiv, Risiko objektiv, Information über Präventionsmöglichkeiten, Bewertung der Präventionsmöglichkeiten und Absprache über weiteres Vorgehen – Herz (define task together, subjective risk, objective risk, information about prevention options and agreement on further action - heart); ATP = adult treatment panel; AU = Australia; AZM = Academisch Ziekenhuis Maastricht (Maastricht University Medical Centre +); BE = Belgium; BMI = body mass index; CA = Canada; CHARLAR = community heart health actions for Latinos at risk; CMD = cardiometabolic disease; CN = China; COHRT = community outreach heart health and risk reduction trial; CONNECT = consumer navigation of electronic cardiovascular tools; CPM = clinical prediction model; CVD = cardiovascular disease; DE = Deutschland (Germany); DECADE = decision-aid, action planning, and follow-up support for patients to reduce the 10-year risk of CVD; DK = Denmark; EU = European Union; FHS = family heart study; FI = Finland; FRS = Framingham risk score; GARDIAN = green, amber, red delineation of risk and need; GP = general practitioner; HAPPY = heart attack prevention program for you; ICVD = ischemic cardiovascular disease; IEHPS = individualised electronic healthcare prescription software; IHD = ischemic heart disease; IMPALA = improving patient adherence to lifestyle advice; IN = India; MyCLIC = my cardiac lifestyle intervention coach; NL = Netherlands; PCE = pooled cohort equations; PROCAM = prospective cardiovascular Münster study; RCT = randomised controlled trial; REACH OUT = risk evaluation and communication health outcomes and utilization trial; SCORE = systematic coronary risk evaluation; SMS = short message service; TAU = Treatment as usual; UK = United Kingdom; UKPDS = United Kingdom prospective diabetes study; USA = United States of America; WHO / ISH = World Health Organization / International Society of Hypertension.
* This publication described two studies, the second did not satisfy our eligibility criteria, and was consequently not included.
Summary of study participants, intervention domains, and decision-aids.
| 16 (50 %) | |||
| 4 (13 %) | |||
| 4 (13 %) | |||
| 8 (25 %) | |||
| 23 (72 %) | |||
| 19 (59 %) | |||
| 16 (50 %) | |||
| 30 (94 %) | |||
| 30 (94 %) | |||
| 31 (97 %) | |||
| 10 (31 %) | |||
| 10 (31 %) | |||
| 9 (28 %) | |||
| 5 (16 %) | |||
| 23 (72 %) | |||
| 6 (19 %) | |||
| 32 (100 %) |
CVD = cardiovascular disease.
Breakdown of the CPMs used in each study, how they were supplemented and used, and whether reporting was lacking detail.
| 1 (3 %) | ||
| 1 (3%) | ||
| 1 (3 %) | ||
| 1 (3%) | ||
| 5 (16 %) | ||
| 1 (3 %) | ||
| 5 (16 %) | ||
| 3 (9 %) | ||
| 1 (3 %) | ||
| 1 (3 %) | ||
| 1 (3 %) | ||
| 1 (3 %) | ||
| 2 (6 %) | ||
| 4 (13 %) | ||
| 1 (3 %) | ||
| 2 (6 %) | ||
| 2 (6 %) | ||
| 1 (3 %) | ||
| 1 (3 %) | ||
| 18 (56 %) | ||
| 3 (9 %) | ||
| 4 (13 %) | ||
| 3 (9 %) | ||
| 1 (3 %) | ||
| 5 (16 %) | ||
| 31 (97 %) | ||
| 20 (63 %) | ||
| 32 (100 %) |
ATP = adult treatment panel; CMD = cardiometabolic disease; CPM = clinical prediction model; FHS = family heart study; FRS = Framingham risk score; ICVD = ischemic cardiovascular disease; PCE = pooled cohort equations; PROCAM = prospective cardiovascular Münster study; SCORE = systematic coronary risk evaluation; UKPDS = United Kingdom prospective diabetes study; WHO / ISH = World Health Organization / International Society of Hypertension.
Summary of reported statistically significant effects in favour of the intervention concerning the primary outcomes.
| 0 / 1 (0 %) | – | |||
| 4 / 8 (50 %) | 5 / 7 (71 %) | |||
| 1 / 2 (50 %) | 1 / 1 (100 %) | |||
| 0 / 2 (0 %) | 1 / 1 (100 %) | |||
| 0 / 1 (0 %) | 0 / 1 (0 %) | |||
| 0 / 1 (0 %) | – | |||
| 1 / 2 (50 %) | 0 / 1 (0 %) | |||
| 1 / 1 (100 %) | 1 / 2 (50 %) | |||
| 1 / 1 (100 %) | 1 / 1 (100 %) | |||
| 1 / 1 (100 %) | 1 / 1 (100 %) | |||
| 0 / 1 (0 %) | – | |||
| 3 / 3 (100 %) | – | |||
| 1 / 1 (100 %) | – | |||
| 1 / 1 (100 %) | – | |||
| 1 / 1 (100 %) | – |
CMD = cardiometabolic disease; CPM = clinical prediction model.