Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study.

BACKGROUND: Digital interventions are increasingly used to support smoking cessation. Ex-smokers iCoach was a widely available app for smoking cessation used by 404,551 European smokers between June 15, 2011, and June 21, 2013. This provides a unique opportunity to investigate the uptake of a freely available digital smoking cessation intervention and its effects on smoking-related outcomes. OBJECTIVE: We aimed to investigate whether there were distinct trajectories of iCoach use, examine which baseline characteristics were associated with user groups (based on the intensity of use), and assess if and how these groups were associated with smoking-related outcomes. METHODS: Analyses were performed using data from iCoach users registered between June 15, 2011, and June 21, 2013. Smoking-related data were collected at baseline and every 3 months thereafter, with a maximum of 8 follow-ups. First, group-based modeling was applied to detect distinct trajectories of app use. This was performed in a subset of steady users who had completed at least 1 follow-up measurement. Second, ordinal logistic regression was used to assess the baseline characteristics that were associated with user group membership. Finally, generalized estimating equations were used to examine the association between the user groups and smoking status, quitting stage, and self-efficacy over time. RESULTS: Of the 311,567 iCoach users, a subset of 26,785 (8.6%) steady iCoach users were identified and categorized into 4 distinct user groups: low (n=17,422, 65.04%), mild (n=4088, 15.26%), moderate (n=4415, 16.48%), and intensive (n=860, 3.21%) users. Older users and users who found it important to quit smoking had higher odds of more intensive app use, whereas men, employed users, heavy smokers, and users with higher self-efficacy scores had lower odds of more intensive app use. User groups were significantly associated with subsequent smoking status, quitting stage, and self-efficacy over time. For all groups, over time, the probability of being a smoker decreased, whereas the probability of being in an improved quitting stage increased, as did the self-efficacy to quit smoking. For all outcomes, the greatest change was observed between baseline and the first follow-up at 3 months. In the intensive user group, the greatest change was seen between baseline and the 9-month follow-up, with the observed change declining gradually in moderate, mild, and low users. CONCLUSIONS: In the subset of steady iCoach users, more intensive app use was associated with higher smoking cessation rates, increased quitting stage, and higher self-efficacy to quit smoking over time. These users seemed to benefit most from the app in the first 3 months of use. Women and older users were more likely to use the app more intensively. Additionally, users who found quitting difficult used the iCoach app more intensively and grew more confident in their ability to quit over time.

Detection of colon cancer recurrences during follow-up care by general practitioners vs surgeons.

BACKGROUND: In the I CARE study, colon cancer patients were randomly assigned to receive follow-up care from either a general practitioner (GP) or a surgeon. Here, we address a secondary outcome, namely, detection of recurrences and effect on time to detection of transferring care from surgeon to GP. METHODS: Pattern, stage, and treatment of recurrences were described after 3 years. Time to event was defined as date of surgery, until date of recurrence or last follow-up, with death as competing event. Effects on time to recurrence and death were estimated as hazard ratios (HRs) using Cox regression. Restricted mean survival times were estimated. RESULTS: Of 303 patients, 141 were randomly assigned to the GP and 162 to the surgeon. Patients were male (67%) with a mean age of 68.0 (8.4) years. During follow-up, 46 recurrences were detected; 18 (13%) in the GP vs 28 (17%) in the surgeon group. Most recurrences were detected via abnormal follow-up tests (74%) and treated with curative intent (59%). Hazard ratio for recurrence was 0.75 (95% confidence interval [CI] = 0.41 to 1.36) in GP vs surgeon group. Patients in the GP group remained in the disease-free state slightly longer (2.76 vs 2.71 years). Of the patients, 38 died during follow-up; 15 (11%) in the GP vs 23 (14%) in the surgeon group. Of these, 21 (55%) deaths were related to colon cancer. There were no differences in overall deaths between the groups (HR = 0.76, 95% CI = 0.39 to 1.46). CONCLUSION: Follow-up provided by GPs vs surgeons leads to similar detection of recurrences. Also, no differences in mortality were found.

Symptoms and seeking supportive care and associations with quality of life after treatment for colon cancer: Results from the I CARE cohort study.

OBJECTIVE: Patients treated for colon cancer report many symptoms that affect quality of life (QoL). Survivorship care aims at QoL improvement. In this study, we assess associations between symptoms and seeking supportive care and lower QoL and QoL changes overtime during survivorship care. METHODS: A prospective cohort of colon cancer survivors. Questionnaires are administered at inclusion and 6 months later to evaluate symptoms, functioning and seeking supportive care including associations with QoL, using the EORTC QLQ-C30. RESULTS: The mean QoL score at the first questionnaire was 82 (scale 1-100), which improved over time. Pain, bowel symptoms and problems in physical, role, cognitive or social functioning are associated with lower QoL at inclusion but are not associated with QoL changes over time. Seeking support for lower bowel symptoms, physical functioning or fatigue is associated with lower QoL. After 6 months, seeking support for upper bowel symptoms or physical functioning is associated with a tendency towards less QoL improvement. CONCLUSION: QoL of colon cancer survivors improves over 6 months, but seeking support for specific symptoms barely contribute to this improvement. IMPLICATIONS: This study confirms the importance of addressing symptoms, problems related to functioning and seeking supportive care during survivorship care.

Effect of general practitioner-led versus surgeon-led colon cancer survivorship care, with or without eHealth support, on quality of life (I CARE): an interim analysis of 1-year results of a randomised, controlled trial.

BACKGROUND: Colon cancer is associated with an increased risk of physical and psychosocial morbidity, even after treatment. General practitioner (GP) care could be beneficial to help to reduce this morbidity. We aimed to assess quality of life (QOL) in patients who received GP-led survivorship care after treatment for colon cancer compared with those who received surgeon-led care. Furthermore, the effect of an eHealth app (Oncokompas) on QOL was assessed in both patient groups. METHODS: We did a pragmatic two-by-two factorial, open-label, randomised, controlled trial at eight hospitals in the Netherlands. Eligible patients were receiving primary surgical treatment for stage I-III colon cancer or rectosigmoid carcinoma and qualified for routine follow-up according to Dutch national guidelines. Patients were randomly assigned (1:1:1:1)-via computer-generated variable block randomisation stratified by age and tumour stage-to survivorship care overseen by a surgeon, survivorship care overseen by a surgeon with access to Oncokompas, survivorship care overseen by a GP, or survivorship care overseen by a GP with access to Oncokompas. Blinding of the trial was not possible. The primary endpoint of the trial was QOL at 5 years, as measured by the change from baseline in the European Organistion for Research and Treatment of Cancer QLQ-C30 summary score. Here, we report an unplanned interim analysis of QOL at the 12-month follow-up. Grouped comparisons were done (ie, both GP-led care groups were compared with both surgeon-led groups, and both Oncokompas groups were compared with both no Oncokompas groups). Differences in change of QOL between trial groups were estimated with linear mixed-effects models. A change of ten units was considered clinically meaningful. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR4860. FINDINGS: Between March 26, 2015, and Nov 21, 2018, 353 patients were enrolled and randomly assigned. There were 50 early withdrawals (27 patient decisions and 23 GP withdrawals). Of the remaining 303 participants, 79 were assigned to surgeon-led care, 83 to surgeon-led care with Oncokompas, 73 to GP-led care, and 68 to GP-led care with Oncokompas. Median follow-up was 12·2 months (IQR 12·0-13·0) in all groups. At baseline, QOL was high in all trial groups. At 12 months, there was no clinically meaningful difference in change from baseline in QOL between the GP-led care groups and the surgeon-led care groups (difference in summary score -2·3 [95% CI -5·0 to 0·4]) or between the Oncokompas and no Oncokompas groups (-0·1 [-2·8 to 2·6]). INTERPRETATION: In terms of QOL, GP-led survivorship care can be considered as an alternative to surgeon-led care within the first year after colon cancer treatment. Other outcomes, including patient and physician preferences, will be important for decisions about the type of survivorship care. FUNDING: Dutch Cancer Society (KWF).

A cardiovascular risk prediction model for older people: Development and validation in a primary care population.

Cardiovascular risk prediction is mainly based on traditional risk factors that have been validated in middle-aged populations. However, associations between these risk factors and cardiovascular disease (CVD) attenuate with increasing age. Therefore, for older people the authors developed and internally validated risk prediction models for fatal and non-fatal CVD, (re)evaluated the predictive value of traditional and new factors, and assessed the impact of competing risks of non-cardiovascular death. Post hoc analyses of 1811 persons aged 70-78 year and free from CVD at baseline from the preDIVA study (Prevention of Dementia by Intensive Vascular care, 2006-2015), a primary care-based trial that included persons free from dementia and conditions likely to hinder successful long-term follow-up, were performed. In 2017-2018, Cox-regression analyses were performed for a model including seven traditional risk factors only, and a model to assess incremental predictive ability of the traditional and eleven new factors. Analyses were repeated accounting for competing risk of death, using Fine-Gray models. During an average of 6.2 years of follow-up, 277 CVD events occurred. Age, sex, smoking, and type 2 diabetes mellitus were traditional predictors for CVD, whereas total cholesterol, HDL-cholesterol, and systolic blood pressure (SBP) were not. Of the eleven new factors, polypharmacy and apathy symptoms were predictors. Discrimination was moderate (concordance statistic 0.65). Accounting for competing risks resulted in slightly smaller predicted absolute risks. In conclusion, we found, SBP, HDL, and total cholesterol no longer predict CVD in older adults, whereas polypharmacy and apathy symptoms are two new relevant predictors. Building on the selected risk factors in this study may improve CVD prediction in older adults and facilitate targeting preventive interventions to those at high risk.

General practitioners' involvement during survivorship care of colon cancer in the Netherlands: primary health care utilization during survivorship care of colon cancer, a prospective multicentre cohort study.

BACKGROUND: Primary health care use increases when cancer is diagnosed. This increase continues after cancer treatment. More generalist care is suggested to improve survivorship care. It is unknown to what extent cancer-related symptoms are currently presented in primary care in this survivorship phase. OBJECTIVE: To analyse primary health care utilization of colon cancer patients during and after treatment with curative intent. METHODS: In a prospective multicentre cohort study among patients with curatively treated colon cancer, we describe the primary health care utilization during the first 5 years of follow-up. Data were collected at general practitioner (GP) practices during 6 months. RESULTS: Of 183 included participants, 153 (84%) consulted their GP resulting in 606 contacts (mean 3.3, standard deviation 3.01) with on average 0.9 contact for colon-cancer-related (CCR) problems in the 6-month study period. Median time after surgery at inclusion was 7.6 months (range 0-58). Abdominal pain and chemotherapy-related problems were the most frequently reported CCR reasons. Of the CCR contacts, 83% was managed in primary care. As time after surgery passed, the number of CCR contacts declined in patients without chemotherapy and remained constant in patients who received chemotherapy. CONCLUSION: Colon cancer survivors contact their GP frequently also for reasons related to cancer. Currently, a formal role for GPs in survivorship care is lacking, but nevertheless GPs provide a substantial amount of care. Working agreements between primary and secondary care are necessary to formalize the GP's role in order to improve the quality of survivorship care.

Effects of Primary Cardiovascular Prevention on Vascular Risk in Older Adults.

INTRODUCTION: Primary cardiovascular prevention through simultaneously targeting multiple risk factors may be even more effective than single risk factor modification in older adults. The effects of multicomponent cardiovascular prevention on cardiovascular risk are explored. STUDY DESIGN: Post hoc analysis of the cluster randomized Prevention of Dementia by Intensive Vascular care trial. SETTING/PARTICIPANTS: Community-dwelling older adults aged 70-78 years, free from cardiovascular disease at baseline (n=2,254, 63.9% of the Prevention of Dementia by Intensive Vascular care trial population). INTERVENTION: Between 2006 and 2015, the intervention group received nurse-led vascular care every 4 months at the general practitioner practice, the control group received care as usual. MAIN OUTCOME MEASURES: Cardiovascular disease events and Systematic COronary Risk Evaluation in Older People (SCORE-OP), an index based on six risk factors for cardiovascular mortality. Effects were adjusted for clustering and assessed using mixed effects Cox proportional-hazard models and linear mixed models respectively. RESULTS: There was no effect of the intervention on cardiovascular disease events (hazard ratio=0.99, 95% CI=0.71, 1.38). During a median follow-up of 6.1 years, SCORE-OP increased from 14.0% and 13.9% to 23.9% and 25.0% in the intervention and control group, respectively (adjusted mean difference in increment in SCORE-OP between the study groups 0.60%, 95% CI= -0.01, 1.20). Exploratory analyses showed a larger reduction of 2.4 mmHg (95% CI=0.9, 3.9) in systolic blood pressure and 1.9% (95% CI=0.4, 3.4) in current cigarette smoking in the intervention group compared with the control group. CONCLUSIONS: Multicomponent cardiovascular prevention did not improve the overall risk profile in older adults in a primary prevention setting, relative to usual care. However, exploratory analyses showed an effect on blood pressure and smoking cessation. Possibly, contrast between study groups was too small because of the Hawthorne (being part of a study) effect and increasing quality of (preventive) health care for older adults, to yield an effect on the risk profile.

Effectiveness of a targeted lifestyle intervention in primary care on diet and physical activity among South Asians at risk for diabetes: 2-year results of a randomised controlled trial in the Netherlands.

OBJECTIVES: In South Asian populations, little is known about the effects of intensive interventions to reduce the risk of type 2 diabetes on health behaviour. We examined the effectiveness at 2 years of a culturally targeted lifestyle intervention on diet, physical activity and determinants of behaviour change among South Asians at risk for diabetes. DESIGN: Randomised controlled trial with de facto masking. SETTING: Primary care. PARTICIPANTS: A total of 536 18- to 60-year-old South Asians at risk for diabetes (ie, with impaired glucose tolerance, impaired fasting glucose or relatively high insulin resistance) were randomised to the intervention (n=283) or a control (n=253) group. Data of 314 participants (n=165 intervention, n=149 control) were analysed. INTERVENTIONS: The culturally targeted intervention consisted of individual counselling using motivational interviewing (six to eight sessions in the first 6 months plus three to four booster sessions), a family session, cooking classes and a supervised physical activity programme. The control group received generic lifestyle advice. OUTCOME MEASURES: We compared changes in physical activity, diet and social-cognitive underlying determinants between the two groups at 2-year follow-up with independent-sample t-tests, chi-square tests and Fisher's exact tests. RESULTS: At the 2-year follow-up, participants in the intervention group were more moderately to vigorously active than at baseline, but compared with changes in the control group, the difference was not significant (change min/week 142.9 vs 0.5, p=0.672). Also, no significant difference was found between the two groups in changes on any of the components of the diet or the social-cognitive determinants of diet and physical activity. CONCLUSIONS: The culturally targeted lifestyle intervention led to high drop-out and was not effective in promoting healthy behaviour among South Asians at risk for diabetes. Given the high a priori risk, we recommend to develop new strategies, preferably more acceptable, to promote healthy behaviour. TRIAL REGISTRATION: NTR1499; Results. www.trialregister.nl/trialreg/admin/rctview.asp?TC=1499.

Web-Based Interventions Targeting Cardiovascular Risk Factors in Middle-Aged and Older People: A Systematic Review and Meta-Analysis.

BACKGROUND: Web-based interventions can improve single cardiovascular risk factors in adult populations. In view of global aging and the associated increasing burden of cardiovascular disease, older people form an important target population as well. OBJECTIVE: In this systematic review and meta-analysis, we evaluated whether Web-based interventions for cardiovascular risk factor management reduce the risk of cardiovascular disease in older people. METHODS: Embase, Medline, Cochrane and CINAHL were systematically searched from January 1995 to November 2014. Search terms included cardiovascular risk factors and diseases (specified), Web-based interventions (and synonyms) and randomized controlled trial. Two authors independently performed study selection, data-extraction and risk of bias assessment. In a meta-analysis, outcomes regarding treatment effects on cardiovascular risk factors (blood pressure, glycated hemoglobin A1c (HbA1C), low-density lipoprotein (LDL) cholesterol, smoking status, weight and physical inactivity) and incident cardiovascular disease were pooled with random effects models. RESULTS: A total of 57 studies (N=19,862) fulfilled eligibility criteria and 47 studies contributed to the meta-analysis. A significant reduction in systolic blood pressure (mean difference -2.66 mmHg, 95% CI -3.81 to -1.52), diastolic blood pressure (mean difference -1.26 mmHg, 95% CI -1.92 to -0.60), HbA1c level (mean difference -0.13%, 95% CI -0.22 to -0.05), LDL cholesterol level (mean difference -2.18 mg/dL, 95% CI -3.96 to -0.41), weight (mean difference -1.34 kg, 95% CI -1.91 to -0.77), and an increase of physical activity (standardized mean difference 0.25, 95% CI 0.10-0.39) in the Web-based intervention group was found. The observed effects were more pronounced in studies with short (<12 months) follow-up and studies that combined the Internet application with human support (blended care). No difference in incident cardiovascular disease was found between groups (6 studies). CONCLUSIONS: Web-based interventions have the potential to improve the cardiovascular risk profile of older people, but the effects are modest and decline with time. Currently, there is insufficient evidence for an effect on incident cardiovascular disease. A focus on long-term effects, clinical endpoints, and strategies to increase sustainability of treatment effects is recommended for future studies.

Smoking prevalence among migrants in the US compared to the US-born and the population in countries of origin.

OBJECTIVES: Smoking among migrants is known to differ from the host population, but migrants' smoking is rarely ever compared to the prevalence of smoking in their country of origin. The goal of this study is to compare the smoking prevalence among migrants to that of both the US-born population and the countries of origin. Further analyses assess the influence of sex, age at time of entry to the US and education level. METHODS: Data of 248,726 US-born and migrants from 14 countries were obtained from the Tobacco Use Supplement to the Current Population Survey (TUS-CPS) from 2006-2007. Data on 108,653 respondents from the corresponding countries of origin were taken from the World Health Survey (WHS) from 2002-2005. RESULTS: The prevalence of smoking among migrants (men: 14.2%, women: 4.1%) was lower than both the US-born group (men: 21.4%, women: 18.1%) and countries of origin (men: 39.4%, women: 11.0%). The gender gap among migrants was smaller than in the countries of origin. Age at time of entry to the US was not related to smoking prevalence for migrants. The risk of smoking for high-educated migrants was closer to their US counterparts. CONCLUSIONS: The smoking prevalence among migrants is consistently lower than both the country of origin levels and the US level. The theory of segmented assimilation is supported by some results of this study, but not all. Other mechanisms that might influence the smoking prevalence among migrants are the 'healthy migrant effect' or the stage of the smoking epidemic at the time of migration.

Effectiveness of a web-based health risk assessment with individually-tailored feedback on lifestyle behaviour: study protocol.

BACKGROUND: Physical inactivity, unhealthy dietary habits, smoking and high alcohol consumption are recognized risk factors for cardiovascular disease and cancer. Web-based health risk assessments with tailored feedback seem promising in promoting a healthy lifestyle. This study evaluates the effectiveness of a web-based health risk assessment with individually-tailored feedback on lifestyle behaviour, conducted in a worksite setting. METHODS/DESIGN: The web-based health risk assessment starts with a questionnaire covering socio-demographic variables, family and personal medical history, lifestyle behaviour and psychological variables. Prognostic models are used to estimate individual cardiovascular risks. In case of high risk further biometric and laboratory evaluation is advised. All participants receive individually-tailored feedback on their responses to the health risk assessment questionnaire. The study uses a quasi-experimental design with a waiting list control group. Data are collected at baseline (T0) and after six months (T1). Within each company, clusters of employees are allocated to either the intervention or the control group. Primary outcome is lifestyle behaviour, expressed as the sum of five indicators namely physical activity, nutrition, smoking behaviour, alcohol consumption, and symptoms of burnout. Multilevel regression analysis will be used to answer the main research question and to correct for clustering effects. Baseline differences between the intervention and control group in the distribution of characteristics with a potential effect on lifestyle change will be taken into account in further analyses using propensity scores. DISCUSSION: This study will increase insight into the effectiveness of health risk assessments with tailored feedback and into conditions that may modify the effectiveness. This information can be used to design effective interventions for lifestyle behaviour change among employees. TRIAL REGISTRATION: Dutch Trial Register NTR8148.

Quality of life and salivary output in patients with head-and-neck cancer five years after radiotherapy.

BACKGROUND: To describe long-term changes in time of quality of life (QOL) and the relation with parotid salivary output in patients with head-and-neck cancer treated with radiotherapy. METHODS: Forty-four patients completed the EORTC-QLQ-C30(+3) and the EORTC-QLQ-H&N35 questionnaires before treatment, 6 weeks, 6 months, 12 months, and at least 3.5 years after treatment. At the same time points, stimulated bilateral parotid flow rates were measured. RESULTS: There was a deterioration of most QOL items after radiotherapy compared with baseline, with gradual improvement during 5 years follow-up. The specific xerostomia-related items showed improvement in time, but did not return to baseline. Global QOL did not alter significantly in time, although 41% of patients complained of moderate or severe xerostomia at 5 years follow-up. Five years after radiotherapy the mean cumulated parotid flow ratio returned to baseline but 20% of patients had a flow ratio <25%. The change in time of xerostomia was significantly related with the change in flow ratio (p = 0.01). CONCLUSION: Most of the xerostomia-related QOL scores improved in time after radiotherapy without altering the global QOL, which remained high. The recovery of the dry mouth feeling was significantly correlated with the recovery in parotid flow ratio.