Cost-effectiveness of a chemoprophylactic intervention with single dose rifampicin in contacts of new leprosy patients

Background

With 249,007 new leprosy patients detected globally in 2008, it remains necessary to develop new and effective interventions to interrupt the transmission of M. leprae. We assessed the economic benefits of single dose rifampicin (SDR) for contacts as chemoprophylactic intervention in the control of leprosy.

Methods

We conducted a single centre, double blind, cluster randomised, placebo controlled trial in northwest Bangladesh between 2002 and 2007, including 21,711 close contacts of 1,037 patients with newly diagnosed leprosy. We gave a single dose of rifampicin or placebo to close contacts, with follow-up for four years. The main outcome measure was the development of clinical leprosy. We assessed the cost effectiveness by calculating the incremental cost effectiveness ratio (ICER) between the standard multidrug therapy (MDT) program with the additional chemoprophylaxis intervention versus the standard MDT program only. The ICER was expressed in US dollars per prevented leprosy case.

Findings

Chemoprophylaxis with SDR for preventing leprosy among contacts of leprosy patients is cost-effective at all contact levels and thereby a cost-effective prevention strategy. In total, $6,009 incremental cost was invested and 38 incremental leprosy cases were prevented, resulting in an ICER of $158 per one additional prevented leprosy case. It was the most cost-effective in neighbours of neighbours and social contacts (ICER $214), slightly less cost-effective in next door neighbours (ICER $497) and least cost-effective among household contacts (ICER $856).

Conclusion

Chemoprophylaxis with single dose rifampicin given to contacts of newly diagnosed leprosy patients is a cost-effective intervention strategy. Implementation studies are necessary to establish whether this intervention is acceptable and feasible in other leprosy endemic areas of the world.     

Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial

Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes.Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level.Setting 207 general practices in 13 primary care sites in the United Kingdom.Participants 824 adults (55% men, mean age 59.5 years).Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care.Main outcome measures Haemoglobin A_1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months.Main results Haemoglobin A_1c levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval −0.10% to 0.20%). The intervention group showed a greater weight loss: −2.98 kg (95% confidence interval −3.54 to −2.41) compared with 1.86 kg (−2.44 to −1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was −0.50 (95% confidence interval −0.96 to −0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=0.12; P=0.008).Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A_1c levels up to 12 months after diagnosis.Trial registration Current Controlled Trials ISRCTN17844016.     

Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial

Objectives To assess the effect of self monitoring of blood glucose concentrations on glycaemic control and psychological indices in patients with newly diagnosed type 2 diabetes mellitus.Design Prospective randomised controlled trial of self monitoring versus no monitoring (control).Setting Hospital diabetes clinics.Participants 184 (111 men) people aged <70 with newly diagnosed type 2 diabetes referred to the participating diabetes clinics. Major exclusion criteria were secondary diabetes, insulin treatment, previous self monitoring of blood glucose.Interventions Participants were randomised to self monitoring or no monitoring (control) groups for one year with follow-up at three monthly intervals. Both groups underwent an identical structured core education programme. The self monitoring group received additional education on monitoring.Main outcome measures Between group differences in HbA_1c, psychological indices, use of oral hypoglycaemic drugs, body mass index (BMI), and reported hypoglycaemia rates.Results 96 patients (55 men) were randomised to monitoring and 88 (56 men) to control. There were no baseline differences in mean (SD) age (57.7 (11.0) in monitoring group v 60.9 (11.5) in control group) or HbA_1c (8.8 (2.1)% v 8.6 (2.3)%, respectively). Those in the monitoring group had a higher baseline BMI (34 (7) v 32 (6.2)). There were no significant differences between groups at any time point (12 months values given) in HbA_1c (6.9 (0.8)% v 6.9 (1.2)%, P=0.69; 95% confidence interval for difference −0.25% to 0.38%), BMI (33.1 (6.4) v 31.8 (6.0); adjusted for baseline BMI, P=0.32), use of oral hypoglycaemic drugs, or reported incidence of hypoglycaemia. Monitoring was associated with a 6% higher score on the depression subscale of the well-being questionnaire (P=0.01).Conclusions In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale.Trial registration ISRCTN 49814766.     

Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial

Objective To evaluate the benefits of paramedic practitioners assessing and, when possible, treating older people in the community after minor injury or illness. Paramedic practitioners have been trained with extended skills to assess, treat, and discharge older patients with minor acute conditions in the community.Design Cluster randomised controlled trial involving 56 clusters. Weeks were randomised to the paramedic practitioner service being active (intervention) or inactive (control) when the standard 999 service was available.Setting A large urban area in England.Participants 3018 patients aged over 60 who called the emergency services (n=1549 intervention, n=1469 control).Main outcome measures Emergency department attendance or hospital admission between 0 and 28 days; interval from time of call to time of discharge; patients'' satisfaction with the service received.Results Overall, patients in the intervention group were less likely to attend an emergency department (relative risk 0.72, 95% confidence interval 0.68 to 0.75) or require hospital admission within 28 days (0.87, 0.81 to 0.94) and experienced a shorter total episode time (235 v 278 minutes, 95% confidence interval for difference −60 minutes to −25 minutes). Patients in the intervention group were more likely to report being highly satisfied with their healthcare episode (relative risk 1.16, 1.09 to 1.23). There was no significant difference in 28 day mortality (0.87, 0.63 to 1.21).Conclusions Paramedics with extended skills can provide a clinically effective alternative to standard ambulance transfer and treatment in an emergency department for elderly patients with acute minor conditions.Trial registration ISRCTN27796329.     

Preventing injuries in children: cluster randomised controlled trial in primary care

ObjectiveTo assess the effectiveness of safety advice at child health surveillance consultations, provision of low cost safety equipment to families receiving means tested state benefits, home safety checks, and first aid training on frequency and severity of unintentional injuries in children at home.DesignCluster randomised controlled trial.Setting36 general practices in Nottingham.SubjectsAll children aged 3-12 months registered with participating practices.InterventionsA package of safety advice at child health surveillance consultations at 6-9, 12-15, and 18-24 months; provision of low cost safety equipment to families on means tested state benefits; and home safety checks and first aid training by health visitors.ResultsAt baseline, both groups had similar risk factors for injury, sociodemographic characteristics, safety practices, possession and use of safety equipment, knowledge and confidence in dealing with first aid, and perceptions of risk. No significant difference was found in frequency of at least one medically attended injury (odds ratio 0.97, 95% confidence interval 0.72 to 1.30), at least one attendance at an accident and emergency department for injury (1.02, 0.76 to 1.37), at least one primary care attendance for injury (0.75, 0.48 to 1.17), or at least one hospital admission for injury (0.69, 0.42 to 1.12). No significant difference in the secondary outcome measures was found between the intervention and control groups. ConclusionsThe intervention package was not effective in reducing the frequency of minor unintentional injuries in children at home, and larger trials are required to assess the effect on more severe injuries.

Key messages

• A package of activities for preventing injuries, as suggested by the Health of the Nation, delivered to families with children aged under 3 in primary care did not reduce the frequency of minor injuries
• The findings were consistent with a reduction in the frequency of more severe injuries, and larger primary care based studies are required to test this hypothesis
• The effectiveness of each of the interventions, delivered singly, is not known

     

Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial

Introduction  

No randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients.     

Effectiveness of out-of-home day care for disadvantaged families: randomised controlled trial

Objective To assess the effects of providing daycare facilities for young children on the health and welfare of disadvantaged families.Design Randomised controlled trial. Eligible children from the application list to a daycare facility were randomly allocated to receive a daycare place or not.Setting Early Years daycare centre in Borough of Hackney, London.Participants 120 mothers and 143 eligible children (aged between 6 months and 3.5 years).Intervention A place at the centre, which provided high quality day care. Control families used other child care that they secured for themselves.Main outcome measures Maternal paid employment, household income, child health and development.Results At 18 months'' follow up, 67% of intervention group mothers and 60% of control group mothers were in paid employment (adjusted risk ratio 1.23 (95% confidence interval 0.99 to 1.52)), but were no more likely to have a weekly household income of above £200 (risk ratio 0.88 (0.70 to 1.09)). Intervention group children had more otitis media with effusion (risk ratio 1.74 (1.02 to 2.96)) and used more health services (1.58 (1.05 to 2.38)), but both estimates were imprecise.Conclusion The provision of child day care may have increased maternal employment, but it did not seem to increase household income. The results suggest that providing day care may be insufficient as a strategy to reduce poverty. The study shows how random allocation can be used to ration and evaluate interventions where demand exceeds supply.     

Screening for abdominal aortic aneurysms: single centre randomised controlled trial

Objective To determine whether screening Danish men aged 65 or more for abdominal aortic aneurysms reduces mortality.Design Single centre randomised controlled trial.Setting All five hospitals in Viborg County, Denmark.Participants All 12 639 men born during 1921-33 and living in Viborg County. In 1994 we included men born 1921-9 (64-73 years). We also included men who became 65 during 1995-8.Interventions Men were randomised to the intervention group (screening by abdominal ultrasonography) or control group. Participants with an abdominal aortic aneurysm > 5 cm were referred for surgical evaluation, and those with smaller aneurysms were offered annual scans.Outcome measures Specific mortality due to abdominal aortic aneurysm, overall mortality, and number of planned and emergency operations for abdominal aortic aneurysms.Results 4860 of 6333 men were screened (attendance rate 76.6%). 191 (4.0% of those screened) had abdominal aortic aneurysms. The mean follow-up time was 52 months. The screened group underwent 75% (95% confidence interval 51% to 91%) fewer emergency operations than the control group. Deaths due to abdominal aortic aneurysms occurred in nine patients in the screened group and 27 in the control group. The number needed to screen to save one life was 352. Specific mortality was significantly reduced by 67% (29% to 84%). Mortality due to non-abdominal aortic aneurysms was non-significantly reduced by 8%. The benefits of screening may increase with time.Conclusion Mass screening for abdominal aortic aneurysms in Danish men aged 65 or more reduces mortality.     

BCG revaccination does not protect against leprosy in the Brazilian Amazon: a cluster randomised trial

Background

Although BCG has been found to impart protection against leprosy in many populations, the utility of repeat or booster BCG vaccinations is still unclear. When a policy of giving a second BCG dose to school children in Brazil was introduced, a trial was conducted to assess its impact against tuberculosis, and a leprosy component was then undertaken in parallel. Objective: to estimate the protection against leprosy imparted by a second dose of BCG given to schoolchildren.

Methods and Findings

This is a cluster randomised community trial, with 6 years and 8 months of follow-up. Study site: City of Manaus, Amazon region, a leprosy-endemic area in Brazil. Participants: 99,770 school children with neonatal BCG (aged 7–14 years at baseline), of whom 42,662 were in the intervention arm (revaccination). Intervention: BCG given by intradermal injection. Main outcome: Leprosy (all clinical forms). Results: The incidence rate ratio of leprosy in the intervention over the control arm within the follow-up, in schoolchildren with neonatal BCG, controlled for potential confounders and adjusted for clustering, was 0.99 (95% confidence interval: 0.68 to 1.45).

Conclusions/Significance

There was no evidence of protection conferred by the second dose of BCG vaccination in school children against leprosy during the trial follow-up. These results point to a need to consider the effectiveness of the current policy of BCG vaccination of contacts of leprosy cases in Brazilian Amazon region.     

Effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy to treat patients with depression: randomised controlled trial

ObjectiveTo assess the effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy.DesignParallel group, cluster randomised, controlled trial of an educational package on cognitive behaviour therapy.SettingGeneral practices in north London.Participants84 general practitioner principals and 272 patients attending their practices who scored above the threshold for psychological distress on the hospital anxiety and depression scale.InterventionA training package of four half days on brief cognitive behaviour therapy.ResultsDoctors'' knowledge of depression and attitudes towards its treatment showed no major difference between intervention and control groups after 6 months. The training had no discernible impact on patients'' outcomes.ConclusionGeneral practitioners may require more training and support than a basic educational package on brief cognitive behaviour therapy to acquire skills to help patients with depression.

What is already known on this topic

Trained professionals can deliver effective cognitive behaviour therapy to depressed patients presenting to general practitionersLimited evidence shows that cognitive behaviour therapy is effective when delivered by general practitioners who have received extensive instructionMost doctors do not have the time or inclination to carry out such comprehensive training

What this study adds

Basic training in brief cognitive behaviour therapy has little effect on general practitioners'' attitudes to the identification and treatment of depression or the outcome of their patients with emotional problemsGeneral practitioners may require more extensive training and support if they are to acquire skills in brief cognitive behaviour therapy that will have a positive impact on their patients     

Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial

Objective To investigate the effect of a structured warm-up programme designed to reduce the incidence of knee and ankle injuries in young people participating in sports.Design Cluster randomised controlled trial with clubs as the unit of randomisation.Setting 120 team handball clubs from central and eastern Norway (61 clubs in the intervention group, 59 in the control group) followed for one league season (eight months).Participants 1837 players aged 15-17 years; 958 players (808 female and 150 male) in the intervention group; 879 players (778 female and 101 male) in the control group.Intervention A structured warm-up programme to improve running, cutting, and landing technique as well as neuromuscular control, balance, and strength.Main outcome measure The rate of acute injuries to the knee or ankle.Results During the season, 129 acute knee or ankle injuries occurred, 81 injuries in the control group (0.9 (SE 0.09) injuries per 1000 player hours; 0.3 (SE 0.17) in training v 5.3 (SE 0.06) during matches) and 48 injuries in the intervention group (0.5 (SE 0.11) injuries per 1000 player hours; 0.2 (SE 0.18) in training v 2.5 (SE 0.06) during matches). Fewer injured players were in the intervention group than in the control group (46 (4.8%) v (76 (8.6%); relative risk intervention group v control group 0.53, 95% confidence interval 0.35 to 0.81).Conclusion A structured programme of warm-up exercises can prevent knee and ankle injuries in young people playing sports. Preventive training should therefore be introduced as an integral part of youth sports programmes.     

Effectiveness of peer-led self-management coaching for patients recently diagnosed with Type 2 diabetes mellitus in primary care: a randomized controlled trial

Diabet. Med. 29, e390-e397 (2012) SUMMARY: Aims To study the effectiveness of a peer-led self-management coaching intervention in recently diagnosed patients with Type 2 diabetes. Methods Randomized controlled trial of recently diagnosed patients with Type 2 diabetes from 54 participating general practices. The intervention group received three home visits by an experienced peer (expert patient) who adhered to the recommended treatment and lifestyle guidelines. Together with their expert patient, participants set feasible goals and these were evaluated in the next visit. Participants in the control group received care as usual. At baseline, 3?months and 6?months post-intervention, participants completed a questionnaire measuring changes in self-efficacy, coping, physical activity, dietary habits, psychological well-being, depressive symptoms and diabetes related distress. Results In total, 327 patients were eligible for inclusion in the study of which 133 consented to participate. In participating patients, self-efficacy, coping and saturated fat intake improved significantly over time. Analyses of participants with low self-efficacy at baseline (25th percentile: 44) revealed a significant time?×?group difference, F?=?3.71; P?=?0.03. Participants who reported low psychological well-being at baseline increased substantially throughout the study (F?=?23.84; P?相似文献   

Evaluation of adjuvant psychological therapy in patients with testicular cancer: randomised controlled trial.

OBJECTIVE: To determine the efficacy of adjuvant psychological therapy in patients with testicular cancer and to compare the characteristics and psychosocial outcomes of men who agreed to participate with those who declined to participate in a randomised trial of psychological intervention. DESIGN: Newly diagnosed patients were asked to participate in a randomised trial of psychological support compared with standard medical care. Participants and non-participants completed self assessment questionnaires at baseline and at 2, 4 and 12 months. SETTING: Testicular Tumour Unit of the Royal Marsden Hospital. SUBJECTS: 73 of 184 (40%) eligible patients agreed to enter the randomised trial (participants) and 81 (44%) declined to participate but agreed to complete further assessments (non-participants). 30 patients wanted no further contact with the researchers. OUTCOME MEASURES: Hospital anxiety and depression scale, psychosocial adjustment to illness scale, Rotterdam symptom checklist, mental adjustment to cancer scale. Only scores on the hospital anxiety and depression scale are reported for evaluating treatment efficacy. RESULTS: 111 of 184 (60%) eligible men declined to participate in the trial. Patients with stage I disease were most likely to refuse to participate. A patient was less likely to participate if he had low volume disease and was receiving no further treatment. Likelihood of participation was associated with stage of disease and with type of primary treatment (P < 0.001 for heterogeneity). Patients with early stage disease (P < 0.001) and fewer physical symptoms (P < 0.001) were less likely to participate. Psychosocial factors associated with participation included anxious preoccupation regarding disease (P = 0.01). There were no differences in outcome between participants and non-participants during follow up. Patients seemed to gain little benefit from adjuvant psychological therapy. At 2 months change from baseline favoured the treated group in the anxiety subscale (mean difference between groups -1.41 (95% confidence interval -2.86 to 0.03)). This was not sustained when adjusted for factors related to the disease. By 12 months change from baseline seemed to favour the control group (mean difference between groups 1.66 (-0.18 to 3.50)). CONCLUSIONS: Patients with testicular cancer seem to have considerable coping abilities. Those who declined to participate in the trial differed from those who participated. Those who agreed to participate may comprise the clinical group who perceive a need for psychological support. No evidence was found to indicate a need for routinely offering adjuvant psychological therapy.     

Befriending carers of people with dementia: randomised controlled trial

Objective To evaluate the effectiveness of a voluntary sector based befriending scheme in improving psychological wellbeing and quality of life for family carers of people with dementia.Design Single blind randomised controlled trial.Setting Community settings in East Anglia and London.Participants 236 family carers of people with primary progressive dementia.Intervention Contact with a befriender facilitator and offer of match with a trained lay volunteer befriender compared with no befriender facilitator contact; all participants continued to receive “usual care.”Main outcome measures Carers’ mood (hospital anxiety and depression scale—depression) and health related quality of life (EuroQoL) at 15 months post-randomisation.Results The intention to treat analysis showed no benefit for the intervention “access to a befriender facilitator” on the primary outcome measure or on any of the secondary outcome measures.Conclusions In common with many carers’ services, befriending schemes are not taken up by all carers, and providing access to a befriending scheme is not effective in improving wellbeing.Trial registration Current Controlled Trials ISRCTN08130075.     

Steroid prophylaxis for prevention of nerve function impairment in leprosy: randomised placebo controlled trial (TRIPOD 1)

Objective To determine whether addition of low dose prednisolone to multidrug treatment can prevent reaction and nerve function impairment in leprosy.Design Multicentre, double blind, randomised, placebo controlled, parallel group trial.Setting Six centres in Bangladesh and Nepal.Participants 636 people with newly diagnosed multibacillary leprosy.Intervention Prednisolone 20 mg/day for three months, with tapering dose in month 4, plus multidrug treatment, compared with multidrug treatment alone.Main outcome measures Signs of reaction, impairment of sensory and motor nerve function, and nerve tenderness needing full dose prednisolone at four months and one year.Results Prednisolone had a significant effect in the prevention of reaction and nerve function impairment at four months (relative risk 3.9, 95% confidence interval 2.1 to 7.3), but this was not maintained at one year (relative risk 1.3, 0.9 to 1.8). Fewer events occurred in the prednisolone group at all time points up to 12 months, but the difference at 12 months was small. Subgroup analysis showed a difference in response between people with and without impairment of nerve function at diagnosis.Conclusions The use of low dose prophylactic prednisolone during the first four months of multidrug treatment for leprosy reduces the incidence of new reactions and nerve function impairment in the short term, but the effect is not sustained at one year. The presence of nerve function impairment at diagnosis may influence the response to low dose prednisolone.     

Involving patients in cardiovascular risk management with nurse-led clinics: a cluster randomized controlled trial

Background

Preventive guidelines on cardiovascular risk management recommend lifestyle changes. Support for lifestyle changes may be a useful task for practice nurses, but the effect of such interventions in primary prevention is not clear. We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk.

Methods

We performed a cluster randomized controlled trial in 25 practices that included 615 patients. The intervention consisted of nurse-led cardiovascular risk management, including risk assessment, risk communication, a decision aid and adapted motivational interviewing. The control group received a minimal nurse-led intervention. The self-reported outcome measures at one year were smoking, alcohol use, diet and physical activity. Nurses assessed 10-year cardiovascular mortality risk after one year.

Results

There were no significant differences between the intervention groups. The effect of the intervention on the consumption of vegetables and physical activity was small, and some differences were only significant for subgroups. The effects of the intervention on the intake of fat, fruit and alcohol and smoking were not significant. We found no effect between the groups for cardiovascular 10-year risk.

Interpretation

Nurse-led risk communication, use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk, despite significant within-group differences.It is not clear if programs for lifestyle change are effective in the primary prevention of cardiovascular diseases. Some studies have shown lifestyle improvements with cardiovascular rehabilitation programs,^1–3 and studies in primary prevention have suggested small, but potentially important, reductions in the risk of cardiovascular disease. However, these studies have had limitations and have recommended further research.^4,5 According to national and international guidelines for cardiovascular risk management, measures to prevent cardiovascular disease, such as patient education and support for lifestyle change, can be delegated to practice nurses in primary care.^6–8 However, we do not know whether the delivery of primary prevention programs by practice nurses is effective. We also do no know the effect of nurse-led prevention, including shared decision-making and risk communication, on cardiovascular risk.Because an unhealthy lifestyle plays an important role in the development of cardiovascular disease,^9,10 preventive guidelines on cardiovascular disease and diabetes recommend education and counselling about smoking, diet, physical exercise and alcohol consumption for patients with moderately and highly increased risk.^6,11 These patients are usually monitored in primary care practices. The adherence to lifestyle advice ranges from 20% to 90%,^12–15 and improving adherence requires effective interventions, comprising cognitive, behavioural and affective components (strategies to influence adherence to lifestyle advice via feelings and emotions or social relationships and social supports).¹⁶ Shared treatment decisions are highly preferred. Informed and shared decision-making requires that all information about the cardiovascular risk and the pros and cons of the risk-reduction options be shared with the patient, and that the patients’ individual values, personal resources and capacity for self-determination be respected.^17–19 In our cardiovascular risk reduction study,²⁰ we developed an innovative implementation strategy that included a central role for practice nurses. Key elements of our intervention included risk assessment, risk communication, use of a decision aid and adapted motivational interviewing (Box 1).^19,21,22

Box 1.?Key features of the nurse-led intervention

• Risk assessment (intervention and control): The absolute 10-year mortality risk from cardiovascular diseases was assessed with use of a risk table from the Dutch guidelines (for patients without diabetes) or the UK Prospective Diabetes Study risk engine (for patients with diabetes).^6,23 Nurses in the control group continued to provide usual care after this step.
• Risk communication (intervention only): Nurses informed the patients of their absolute 10-year cardiovascular mortality risk using a risk communication tool developed for this study.^24–37
• Decision support (intervention only): Nurses provied support to the patients using an updated decision aid.²⁸ This tool facilitated the nurses’ interaction with the patients to arrive at informed, value-based choices for risk reduction. The tool provided information about the options and their associated relevant outcomes.
• Adapted motivational interviewing (intervention only): Nurses discussed the options for risk reduction. The patient’s personal values were elicited using adapted motivational interviewing.

In the present study, we investigated whether a nurse-led intervention in primary care had a positive effect on lifestyle and 10-year cardiovascular risk. We hypothesized that involving patients in decision-making would increase adherence to lifestyle changes and decrease the absolute risk of 10-year cardiovascular mortality.