Pulsed field versus cryoballoon ablation for atrial fibrillation: a real-world observational study on procedural outcomes and efficacy.

INTRODUCTION: Atrial fibrillation often necessitates catheter ablation when antiarrhythmic drug therapy fails. Single-shot technologies using thermal energy, such as cryoballoon ablation, are commonly used, but pulsed field ablation (PFA), an innovative non-thermal ablation technique, is a potential alternative. This retrospective observational study aimed to compare the safety and efficacy of cryoballoon ablation and PFA in patients undergoing their first pulmonary vein isolation (PVI) procedure for atrial fibrillation treatment. METHODS: We utilised real-world data from patients who underwent PVI using cryoballoon ablation or PFA. The primary outcome encompassed procedural complications, including phrenic nerve palsy, cardiac tamponade, thromboembolic complications, bleeding complications and mortality. Secondary outcomes were procedural characteristics including procedure duration, length of hospital admission, and re-do ablation rates within 6 months. RESULTS: A total of 1714 procedures were analysed: 1241 in the cryoballoon group and 473 in the PFA group. Gender distribution (p = 0.03) and estimated glomerular filtration rate (p = 0.01) differed significantly. With regard to the primary outcome, the cryoballoon group demonstrated a higher incidence of phrenic nerve palsy compared with the PFA group (15 vs 0; p = 0.02). The procedure duration was shorter in the PFA group, even after adjusting for baseline characteristics (95.0 vs 74.0 min; p < 0.001). After adjustment for baseline characteristics, admission duration differed between the groups as well (p = 0.04). CONCLUSION: The study results supported the safety and efficacy of PFA over cryoballoon ablation for PVI, highlighting advantages such as shorter procedure duration and absence of phrenic nerve palsy.

Results of systematic patient outcome monitoring: Does post-dilatation during angiography-guided percutaneous coronary intervention improve clinical outcomes?

OBJECTIVES: This study evaluates clinical outcomes after implementing a liberal post-dilatation strategy during PCI. BACKGROUND: Post-dilatation after percutaneous coronary intervention (PCI) is performed to achieve optimal stent expansion and reduce complications. However, its prognostic effects are unclear and conflicting. METHODS: This study is a pre-post-intervention analysis of two cohorts, before (2015-2017) and after (2018-2020) implementation of a liberal post-dilatation strategy. The primary end point consisted of major adverse cardiovascular events (MACE) at 30 days. Secondary end points consisted of the individual components of the primary end point as well as 1 year mortality and target vessel revascularization. RESULTS: A total of 10,153 patients were included: 5,383 in the pre-cohort and 4,770 in the post-cohort. The 30-day MACE was 5.00% in the pre-cohort and 4.09% in the post-cohort (p = 0.008; OR 0.75 (CI 0.61-0.93)). There was a significant difference between the pre- and post-cohort in 30-day mortality, respectively, 2.91% and 2.25% (p = .01; OR 0.70 (CI 0.53-0.93)), and MI at 30 days, 1.17% versus 0.59% (p = .003; OR 0.49 (CI 0.31-0.78)). At 1 year, there was a significant difference in mortality between the pre-cohort, 5.84%, and post-cohort, 5.19% (p = .02; OR 0.79 (CI 0.66-0.96)). CONCLUSIONS: A liberal post-dilatation strategy after PCI was associated with a significant decrease in 30-day MACE, 30-day MI, 30-day mortality, and 1-year mortality. Future studies are warranted to validate the causality between post-dilatation and improvement of clinical outcomes.

Direct admission versus interhospital transfer for revascularisation in non-ST-segment elevation myocardial infarction.

BACKGROUND: The differences in outcomes and process parameters for NSTEMI patients who are directly admitted to an intervention centre and patients who are first admitted to a general centre are largely unknown. HYPOTHESIS: There are differences in process indicators, but not for clinical outcomes, for NSTEMI who are directly admitted to an intervention centre and patients who are first admitted to a general centre. METHODS: We aim to compare process indicators, costs and clinical outcomes of non-ST-segment elevation myocardial infarction (NSTEMI) patients stratified by center of first presentation and revascularisation strategy. Hospital claim data from patients admitted with a NSTEMI between 2017 and 2019 were used for this study. Included patients were stratified by center of admission (intervention vs. general center) and subdivided by revascularisation strategy (PCI, CABG, or no revascularisation [noRevasc]). The primary outcome was length of hospital stay. Secondary outcomes included: duration between admission and diagnostic angiography and revascularisation, number of intracoronary procedures, clinical outcomes at 30 days (MACE: all-cause mortality, recurrent myocardial infarction and cardiac readmission) and total costs (accumulation of costs for hospital claims and interhospital ambulance rides). RESULTS: A total of 9641 NSTEMI events (9167 unique patients) were analyzed of which 5399 patients (56%) were admitted at an intervention center and 4242 patients to a general center. Duration of hospitalization was significantly shorter at direct presentation at an intervention centre for all study groups (5 days [2-11] vs. 7 days [4-12], p < 0.001). For PCI, direct presentation at an intervention center yielded shorter time to diagnostic angiography (1 day [0-2] vs. 1 day [1-2], p < 0.01) and revascularisation (1 day [0-3] vs. 4 days [1-7], p < 0.001) and less intracoronary procedures per patient (2 [1-2] vs. 2 [2-2], p < 0.001). For CABG, time to revascularisation was shorter (8 days [5-12] vs. 10 days [7-14], p < 0.001). Total costs were significantly lower in case of direct presentation in an intervention center for all treatment groups €10.211 (8750-18.192) versus €13.741 (11.588-19.381), p < 0.001) while MACE was similar 11.8% versus 12.4%, p = 0.344). CONCLUSION: NSTEMI patients who were directly presented to an intervention center account for shorter duration of hospitalization, less time to revascularisation, less interhospital transfers, less intracoronary procedures and lower costs compared to patients who present at a general center.

Introduction of a New Method to Monitor Patient-Relevant Outcomes and Costs: Using a Quality Improvement Project in Transcatheter Aortic Valve Implantation Care as an Example.

BACKGROUND AND OBJECTIVE: Routine outcome monitoring is becoming standard in care evaluations, but costs are still underrepresented in these efforts. The primary aim of this study was therefore to assess if patient-relevant cost drivers can be used alongside clinical outcomes to evaluate an improvement project and to provide insight into (remaining) areas for improvement. METHODS: Data from patients who underwent transcatheter aortic valve implantation (TAVI) between 2013 and 2018 at a single center in the Netherlands were used. A quality improvement strategy was implemented in October 2015, and pre- (A) and post-quality improvement cohorts (B) were distinguished. For each cohort, clinical outcomes, quality of life (QoL), and cost drivers were collected from the national cardiac registry and hospital registration data. The most appropriate cost drivers in TAVI care were selected from hospital registration data using a novel stepwise approach with an expert panel of physicians, managers, and patient representatives. A radar chart was used to visualize the clinical outcomes, QoL and the selected costs drivers. RESULTS: We included 81 patients in cohort A and 136 patients in cohort B. All-cause mortality at 30 days was borderline significantly lower in cohort B than in cohort A (1.5% vs 7.4%, P = .055). QoL improved after TAVI for both cohorts. The stepwise approach resulted in 21 patient-relevant cost drivers. Costs for pre-procedural outpatient clinic visits (€535, interquartile range [IQR] = 321-675, vs €650, IQR = 512-890, P < .001), costs for the procedure (€1354, IQR = 1236-1686, vs €1474, IQR = 1372-1620, P < .001), and imaging during admission (€318, IQR = 174-441, vs €329, IQR = 267-682, P = .002) were significantly lower in cohort B than in cohort A. Possible improvement potential was seen in 30-day pacemaker implantation and 120-day readmission. CONCLUSION: A selection of patient-relevant cost drivers is a valuable addition to clinical outcomes for use in evaluation of improvement projects and identification of room for further improvement.

Improving clinical outcomes and patient satisfaction among patients with coronary artery disease: an example of enhancing regional integration between a cardiac centre and a referring hospital.

BACKGROUND: Value-based healthcare (VBHC) is a promising strategy to increase patient value. For a successful implementation of VBHC, intensive collaborations between organizations and integrated care delivery systems are key conditions. Our aim was to evaluate the effects of a pilot study regarding enhancing regional integration between a cardiac centre and a referring hospital on patient-relevant clinical outcomes and patient satisfaction. METHODS: The study population consisted of a sample of patients treated for coronary artery disease by use of a coronary artery bypass graft (CABG) or a percutaneous coronary intervention between 2011 and 2016. Since 2013, the two hospitals have implemented different interventions to improve clinical outcomes and the degree of patient satisfaction, e.g. improvement of communication, increased consultant capacity, introduction of outpatient clinic for complex patients, and improved guideline adherence. To identify intervention effects, logistic regression analyses were conducted. Patients' initial conditions, like demographics and health status, were included in the model as predictors. Clinical data extracted from the electronic health records and the hospitals' cardiac databases as well as survey-based data were used. RESULTS: Our findings indicate a non-significant increase of event-free survival of patients treated for coronary artery disease between 2014 and 2016 compared to patients treated between 2011 and 2013 (97.4% vs. 96.7% respectively). This non-significant improvement over time has led to significant better outcomes for patients referred from the study referring hospital compared to patients referred from other hospitals. The level of patient satisfaction (response rate 32.2%; 216 out of 669) was improved and reached statistically significant higher scores regarding patient information and education (p = .013), quality of care (p = .007), hospital admission and stay (p = .032), personal contact with the physician (p = .024), and total impression (p = .007). CONCLUSIONS: This study shows a promising effect of regional integration. An intensified collaboration in the care chain, organized in a structured manner between a cardiac centre and a referring hospital and aiming at high quality, resulted in successful improvement of clinical outcomes and degree of patient satisfaction. The applied method may be used as a starting point of regional integration with other referring hospitals. We encourage others to organize the whole care chain to continuously improve patient-relevant outcomes and patient satisfaction. TRIAL REGISTRATION: ISRCTN11311830. Registered 01 October 2018 (retrospectively registered).

Use of an intraoperative checklist to decrease the incidence of re-exploration for postoperative bleeding after cardiac surgery.

OBJECTIVES: We have implemented an intraoperative checklist aiming to reduce the incidence of re-exploration for bleeding after cardiac surgery. The present report addresses the results of adopting such a checklist regarding the incidence of postoperative bleeding. METHODS: The checklist was implemented by presenting it in several staff meetings of the Catharina Heart Center. Copies of the checklist were presented in every operating room. Data were collected by the Catharina Heart Center, aligned with the 'Meetbaar Beter' data manual and validated by 'Meetbaar Beter' through their data quality system. The incidence of re-exploration for bleeding was analysed in a variable life-adjusted display curve. The patient population operated after the implementation of the checklist was compared with a recent historical population before its implementation. RESULTS: From January 2013 through April 2016, 4817 cardiac surgical procedures were performed in our institution. Before May 2015, 3210 procedures were performed (Group 1), complicated by 112 re-exploration for bleeding (3.5%). The 'reoperation for bleeding checklist' was implemented on 1 May 2015. After this date, the number of re-explorations for bleeding decreased to 29 (1.8%) of the 1607 cardiac surgical procedures (Group 2) (P < 0.05). CONCLUSIONS: An intraoperative checklist is feasible to implement, low cost, quick and simple to measure with a significant reduction in the incidence of re-exploration for bleeding. This report shows an example of the positive effects of transparency in publishing outcomes' data in cardiac surgery.

Who Follows eHealth Interventions as Recommended? A Study of Participants' Personal Characteristics From the Experimental Arm of a Randomized Controlled Trial.

BACKGROUND: Computer-tailored eHealth interventions to improve health behavior have been demonstrated to be effective and cost-effective if they are used as recommended. However, different subgroups may use the Internet differently, which might also affect intervention use and effectiveness. To date, there is little research available depicting whether adherence to intervention recommendations differs according to personal characteristics. OBJECTIVE: The aim was to assess which personal characteristics are associated with using an eHealth intervention as recommended. METHODS: A randomized controlled trial was conducted among a sample of the adult Dutch population (N=1638) testing an intervention aimed at improving 5 healthy lifestyle behaviors: increasing fruit and vegetable consumption, increasing physical activity, reducing alcohol intake, and promoting smoking cessation. Participants were asked to participate in those specific online modules for which they did not meet the national guideline(s) for the respective behavior(s). Participants who started with fewer than the recommended number of modules of the intervention were defined as users who did not follow the intervention recommendation. RESULTS: The fewer modules recommended to participants, the better participants adhered to the intervention modules. Following the intervention recommendation increased when participants were older (χ(2)1=39.8, P<.001), female (χ(2)1=15.8, P<.001), unemployed (χ(2)1=7.9, P=.003), ill (χ(2)1=4.5, P=.02), or in a relationship (χ(2)1=7.8, P=.003). No significant relevant differences were found between groups with different levels of education, incomes, or quality of life. CONCLUSION: Our findings indicate that eHealth interventions were used differently by subgroups. The more frequent as-recommended intervention use by unemployed, older, and ill participants may be an indication that these eHealth interventions are attractive to people with a greater need for health care information. Further research is necessary to make intervention use more attractive for people with unhealthy lifestyle patterns.

Tailored eHealth Lifestyle Promotion: Which Behavioral Modules Do Users Prefer?

Health risk behaviors are widespread among adults and often co-occur. eHealth computer-tailored technology provides individuals with personalized feedback regarding multiple lifestyle behaviors. First, the authors investigated individuals' preferences for particular lifestyle modules and hypothesised that health preventive behavior modules would be preferred over addictive behavior modules. Second, characteristics associated with these choices were examined. A web-based questionnaire assessed demographics, health status, and five lifestyle behaviors (i.e., physical activity, fruit consumption, vegetable consumption, alcohol intake and tobacco use) among adults (N = 1,828). Responses were translated into a health risk appraisal outlining whether respondents adhered to the national guidelines for these behaviors. Next, respondents could select one of the lifestyle modules providing personalized advice. More than 60% of the participants failed to meet the guidelines for more than one lifestyle behavior. The physical activity module was the most popular, followed by the smoking and fruit modules. Young adults tended to prefer the physical activity and fruit modules, whereas the vegetable module was more popular among older adults. No consistent pattern was identified for the alcohol and smoking modules. The results support the authors' hypothesis that health preventive behaviors-in particular, physical activity-would be preferred. Although this could imply that physical activity could serve as a gateway behavior when aiming at multiple behavior changes, it is also conceivable that other mechanisms, such as the actual success of behavior change, or the fact that people can choose, may increase chances of multiple behavior change. Hence, mechanisms leading to multiple behavior change need to be further explored.

An economic evaluation of a video- and text-based computer-tailored intervention for smoking cessation: a cost-effectiveness and cost-utility analysis of a randomized controlled trial.

BACKGROUND: Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. OBJECTIVE: The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. METHODS: In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. RESULTS: No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. CONCLUSION: The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run. TRIAL REGISTRATION: Nederlands Trial Register NTR3102.

Economic evaluation of a web-based tailored lifestyle intervention for adults: findings regarding cost-effectiveness and cost-utility from a randomized controlled trial.

BACKGROUND: Different studies have reported the effectiveness of Web-based computer-tailored lifestyle interventions, but economic evaluations of these interventions are scarce. OBJECTIVE: The objective was to assess the cost-effectiveness and cost-utility of a sequential and a simultaneous Web-based computer-tailored lifestyle intervention for adults compared to a control group. METHODS: The economic evaluation, conducted from a societal perspective, was part of a 2-year randomized controlled trial including 3 study groups. All groups received personalized health risk appraisals based on the guidelines for physical activity, fruit intake, vegetable intake, alcohol consumption, and smoking. Additionally, respondents in the sequential condition received personal advice about one lifestyle behavior in the first year and a second behavior in the second year; respondents in the simultaneous condition received personal advice about all unhealthy behaviors in both years. During a period of 24 months, health care use, medication use, absenteeism from work, and quality of life (EQ-5D-3L) were assessed every 3 months using Web-based questionnaires. Demographics were assessed at baseline, and lifestyle behaviors were assessed at both baseline and after 24 months. Cost-effectiveness and cost-utility analyses were performed based on the outcome measures lifestyle factor (the number of guidelines respondents adhered to) and quality of life, respectively. We accounted for uncertainty by using bootstrapping techniques and sensitivity analyses. RESULTS: A total of 1733 respondents were included in the analyses. From a willingness to pay of €4594 per additional guideline met, the sequential intervention (n=552) was likely to be the most cost-effective, whereas from a willingness to pay of €10,850, the simultaneous intervention (n=517) was likely to be most cost-effective. The control condition (n=664) appeared to be preferred with regard to quality of life. CONCLUSIONS: Both the sequential and the simultaneous lifestyle interventions were likely to be cost-effective when it concerned the lifestyle factor, whereas the control condition was when it concerned quality of life. However, there is no accepted cutoff point for the willingness to pay per gain in lifestyle behaviors, making it impossible to draw firm conclusions. Further economic evaluations of lifestyle interventions are needed. TRIAL REGISTRATION: Dutch Trial Register NTR2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB).

Effects of a web-based tailored multiple-lifestyle intervention for adults: a two-year randomized controlled trial comparing sequential and simultaneous delivery modes.

BACKGROUND: Web-based computer-tailored interventions for multiple health behaviors can have a significant public health impact. Yet, few randomized controlled trials have tested this assumption. OBJECTIVE: The objective of this paper was to test the effects of a sequential and simultaneous Web-based tailored intervention on multiple lifestyle behaviors. METHODS: A randomized controlled trial was conducted with 3 tailoring conditions (ie, sequential, simultaneous, and control conditions) in the Netherlands in 2009-2012. Follow-up measurements took place after 12 and 24 months. The intervention content was based on the I-Change model. In a health risk appraisal, all respondents (N=5055) received feedback on their lifestyle behaviors that indicated whether they complied with the Dutch guidelines for physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking. Participants in the sequential (n=1736) and simultaneous (n=1638) conditions received tailored motivational feedback to change unhealthy behaviors one at a time (sequential) or all at the same time (simultaneous). Mixed model analyses were performed as primary analyses; regression analyses were done as sensitivity analyses. An overall risk score was used as outcome measure, then effects on the 5 individual lifestyle behaviors were assessed and a process evaluation was performed regarding exposure to and appreciation of the intervention. RESULTS: Both tailoring strategies were associated with small self-reported behavioral changes. The sequential condition had the most significant effects compared to the control condition after 12 months (T1, effect size=0.28). After 24 months (T2), the simultaneous condition was most effective (effect size=0.18). All 5 individual lifestyle behaviors changed over time, but few effects differed significantly between the conditions. At both follow-ups, the sequential condition had significant changes in smoking abstinence compared to the simultaneous condition (T1 effect size=0.31; T2 effect size=0.41). The sequential condition was more effective in decreasing alcohol consumption than the control condition at 24 months (effect size=0.27). Change was predicted by the amount of exposure to the intervention (total visiting time: beta=-.06; P=.01; total number of visits: beta=-.11; P<.001). Both interventions were appreciated well by respondents without significant differences between conditions. CONCLUSIONS: Although evidence was found for the effectiveness of both programs, no simple conclusive finding could be drawn about which intervention mode was more effective. The best kind of intervention may depend on the behavior that is targeted or on personal preferences and motivation. Further research is needed to identify moderators of intervention effectiveness. The results need to be interpreted in view of the high and selective dropout rates, multiple comparisons, and modest effect sizes. However, a large number of people were reached at low cost and behavioral change was achieved after 2 years. TRIAL REGISTRATION: Nederlands Trial Register: NTR 2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB).

Effects of a Web-based tailored intervention to reduce alcohol consumption in adults: randomized controlled trial.

BACKGROUND: Web-based tailored interventions provide users with information that is adapted to their individual characteristics and needs. Randomized controlled trials assessing the effects of tailored alcohol self-help programs among adults are scarce. Furthermore, it is a challenge to develop programs that can hold respondents' attention in online interventions. OBJECTIVE: To assess whether a 3-session, Web-based tailored intervention is effective in reducing alcohol intake in high-risk adult drinkers and to compare 2 computer-tailoring feedback strategies (alternating vs summative) on behavioral change, dropout, and appreciation of the program. METHODS: A single-blind randomized controlled trial was conducted with an experimental group and a control group (N=448) in Germany in 2010-2011. Follow-up took place after 6 months. Drinking behavior, health status, motivational determinants, and demographics were assessed among participants recruited via an online access panel. The experimental group was divided into 2 subgroups. In the alternating condition (n=132), the tailored feedback was split into a series of messages discussing individual topics offered while the respondent was filling out the program. Participants in the summative condition (n=181) received all advice at once after having answered all questions. The actual texts were identical for both conditions. The control group (n=135) only filled in 3 questionnaires. To identify intervention effects, logistic and linear regression analyses were conducted among complete cases (n=197) and after using multiple imputation. RESULTS: Among the complete cases (response rate: 197/448, 44.0%) who did not comply with the German national guideline for low-risk drinking at baseline, 21.1% of respondents in the experimental group complied after 6 months compared with 5.8% in the control group (effect size=0.42; OR 2.65, 95% CI 1.14-6.16, P=.02). The experimental group decreased by 3.9 drinks per week compared to 0.4 drinks per week in the control group, but this did not reach statistical significance (effect size=0.26; beta=-0.12, 95% CI -7.96 to 0.03, P=.05). Intention-to-treat analyses also indicated no statistically significant effect. Separate analyses of the 2 experimental subgroups showed no differences in intervention effects. The dropout rate during the first visit to the intervention website was significantly lower in the alternating condition than in the summative condition (OR 0.23, 95% CI 0.08-0.60, P=.003). Program appreciation was comparable for the 2 experimental groups. CONCLUSIONS: Complete case analyses revealed that Web-based tailored feedback can be an effective way to reduce alcohol intake among adults. However, this effect was not confirmed when applying multiple imputations. There was no indication that one of the tailoring strategies was more effective in lowering alcohol intake. Nevertheless, the lower attrition rates we found during the first visit suggest that the version of the intervention with alternating questions and advice may be preferred. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 91623132; http://www.controlled-trials.com/ISRCTN91623132 (Archived by WebCite at http://www.webcitation.org/6J4QdhXeG).

The use of a proactive dissemination strategy to optimize reach of an internet-delivered computer tailored lifestyle intervention.

BACKGROUND: The use of reactive strategies to disseminate effective Internet-delivered lifestyle interventions restricts their level of reach within the target population. This stresses the need to invest in proactive strategies to offer these interventions to the target population. The present study used a proactive strategy to increase reach of an Internet-delivered multi component computer tailored intervention, by embedding the intervention in an existing online health monitoring system of the Regional Public Health Services in the Netherlands. METHODS: The research population consisted of Dutch adults who were invited to participate in the Adult Health Monitor (N = 96,388) offered by the Regional Public Health Services. This Monitor consisted of an online or a written questionnaire. A prospective design was used to determine levels of reach, by focusing on actual participation in the lifestyle intervention. Furthermore, adequacy of reach among the target group was assessed by composing detailed profiles of intervention users. Participants' characteristics, like demographics, behavioral and mental health status and quality of life, were included in the model as predictors. RESULTS: A total of 41,155 (43%) people participated in the Adult Health Monitor, of which 41% (n = 16,940) filled out the online version. More than half of the online participants indicated their interest (n = 9169; 54%) in the computer tailored intervention and 5168 participants (31%) actually participated in the Internet-delivered computer tailored intervention. Males, older respondents and individuals with a higher educational degree were significantly more likely to participate in the intervention. Furthermore, results indicated that especially participants with a relatively healthier lifestyle and a healthy BMI were likely to participate. CONCLUSIONS: With one out of three online Adult Health Monitor participants actually participating in the computer tailored lifestyle intervention, the employed proactive dissemination strategy succeeded in ensuring relatively high levels of reach. Reach among at-risk individuals (e.g. low socioeconomic status and unhealthy lifestyle) was modest. It is therefore essential to further optimize reach by putting additional effort into increasing interest in the lifestyle intervention among at-risk individuals and to encourage them to actually use the intervention. TRIAL REGISTRATION: Dutch Trial Register (NTR1786) and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016).

Are the stages of change relevant for the development and implementation of a web-based tailored alcohol intervention? A cross-sectional study.

BACKGROUND: Computer-tailored programs are a promising tool to stimulate health behavior change, such as reducing alcohol intake. Yet more research is needed to assess whether groups differing in their motivational level to change may need different types of feedback. Furthermore, it is unknown whether motivational level may also determine reactions to computer-tailored interventions. Our aim is to identify the potential relevance of the application of the stages of change concept in the development and implementation of alcohol interventions. METHODS: A web-based instrument was used to disseminate a questionnaire and to provide tailored feedback messages among adults in the Netherlands (N = 170; 96 females). Motivational level was assessed by the stage of change construct. The survey furthermore assessed alcohol consumption, attitude, social influence, self-efficacy, and program evaluation (i.e., survey items, tailored advice, layout and functionality of the program). The Least Significant Difference method was used to compare people in different stages of change with regard to psychosocial determinants of drinking behavior and program evaluation. RESULTS: Of the respondents, 34.1% (n = 58) reported no intention to change to healthier drinking habits in the foreseeable future (precontemplation), 22.9% (n = 39) intended to improve their drinking behavior in the near future (contemplation/preparation) and 42.9% (n = 73) reported to currently adhere to the Dutch alcohol consumption guidelines (action/maintenance). When comparing the three groups, people in the action or maintenance stage reported the lowest number of pros of drinking alcohol, having most healthy drinking role models and the highest levels of self-efficacy regarding healthy drinking in difficult situations, whereas precontemplators reported to receive the least social support regarding healthy drinking. In general, the intervention was positively evaluated, but it seemed to be most appreciated by contemplators and preparers. CONCLUSIONS: Stage-matched interventions may be useful to encourage people to reduce their alcohol intake. Different factors seem to be important for people in different motivational stages. Longitudinal studies are needed to determine whether these factors also predict stage transition. The intervention could be optimized by tailoring the feedback messages more precisely to the needs of people in different motivational stages, for example by applying the different processes of change.

The influence of user characteristics and a periodic email prompt on exposure to an internet-delivered computer-tailored lifestyle program.

BACKGROUND: The Internet is a promising medium in the field of health promotion for offering tailored and targeted lifestyle interventions applying computer-tailored (CT) techniques to the general public. Actual exposure to CT interventions is not living up to its high expectations, as only a (limited) proportion of the target group is actually using these programs. OBJECTIVE: To investigate exposure to an Internet-delivered, CT lifestyle intervention, targeting physical activity, fruit and vegetable intake, smoking behavior, and alcohol intake, we focused on three processes: first use, prolonged use, and sustained use. The first objectives were to identify user characteristics that predict initiation of an online CT lifestyle program (first use) and completion of this program (prolonged use). Furthermore, we studied the effect of using a proactive strategy, consisting of periodic email prompts, on program revisits (sustained use). METHODS: The research population for this study consisted of Dutch adults participating in the Adult Health Monitor, offered by the regional public health services. We used a randomized controlled trial design to assess predictors of first use, prolonged use, and sustained use. Demographics and behavioral characteristics, as well as the strategy used for revisiting, were included as predictors in the model. RESULTS: A total of 9169 participants indicated their interest in the new program and 5168 actually logged in to the program. Participants significantly more likely to initiate one of the CT modules were male, older, and employed, and had a lower income, higher body mass index, and relatively unhealthy lifestyle. Participants significantly more likely to complete one of the CT modules were older and had a higher income and a relatively healthier lifestyle. Finally, using a proactive strategy influenced sustained use, with people from the prompting condition being more likely to revisit the program (odds ratio 28.92, 95% confidence interval 10.65-78.52; P < .001). CONCLUSIONS: Older, male, and employed participants, and those with a lower income, higher body mass index, and a relatively unhealthy lifestyle were more likely to initiate a CT module. Module completers predominantly had a higher income and age. The current program therefore succeeded in reaching those people who benefit most from online lifestyle interventions. However, these people tended to disengage from the program. This underlines the importance of additional research into program adjustments and strategies that can be used to stimulate prolonged program use. Furthermore, sending periodic email prompts significantly increased revisits to the program. Though promising, this effect was modest and needs to be further examined, in order to maximize the potential of periodic email prompting. TRIAL REGISTRATION: Nederlands Trial Register (NTR: 1786) and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1786 (Archived by WebCite at http://www.webcitation.org/65hBXA6V7).

Program completion of a web-based tailored lifestyle intervention for adults: differences between a sequential and a simultaneous approach.

BACKGROUND: Unhealthy lifestyle behaviors often co-occur and are related to chronic diseases. One effective method to change multiple lifestyle behaviors is web-based computer tailoring. Dropout from Internet interventions, however, is rather high, and it is challenging to retain participants in web-based tailored programs, especially programs targeting multiple behaviors. To date, it is unknown how much information people can handle in one session while taking part in a multiple behavior change intervention, which could be presented either sequentially (one behavior at a time) or simultaneously (all behaviors at once). OBJECTIVES: The first objective was to compare dropout rates of 2 computer-tailored interventions: a sequential and a simultaneous strategy. The second objective was to assess which personal characteristics are associated with completion rates of the 2 interventions. METHODS: Using an RCT design, demographics, health status, physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking were self-assessed through web-based questionnaires among 3473 adults, recruited through Regional Health Authorities in the Netherlands in the autumn of 2009. First, a health risk appraisal was offered, indicating whether respondents were meeting the 5 national health guidelines. Second, psychosocial determinants of the lifestyle behaviors were assessed and personal advice was provided, about one or more lifestyle behaviors. RESULTS: Our findings indicate a high non-completion rate for both types of intervention (71.0%; n = 2167), with more incompletes in the simultaneous intervention (77.1%; n = 1169) than in the sequential intervention (65.0%; n = 998). In both conditions, discontinuation was predicted by a lower age (sequential condition: OR = 1.04; P < .001; CI = 1.02-1.05; simultaneous condition: OR = 1.04; P < .001; CI = 1.02-1.05) and an unhealthy lifestyle (sequential condition: OR = 0.86; P = .01; CI = 0.76-0.97; simultaneous condition: OR = 0.49; P < .001; CI = 0.42-0.58). In the sequential intervention, being male (OR = 1.27; P = .04; CI = 1.01-1.59) also predicted dropout. When respondents failed to adhere to at least 2 of the guidelines, those receiving the simultaneous intervention were more inclined to drop out than were those receiving the sequential intervention. CONCLUSION: Possible reasons for the higher dropout rate in our simultaneous intervention may be the amount of time required and information overload. Strategies to optimize program completion as well as continued use of computer-tailored interventions should be studied. TRIAL REGISTRATION: Dutch Trial Register NTR2168.

Optimizing diffusion of an online computer tailored lifestyle program: a study protocol.

BACKGROUND: Although the Internet is a promising medium to offer lifestyle interventions to large amounts of people at relatively low costs and effort, actual exposure rates of these interventions fail to meet the high expectations. Since public health impact of interventions is determined by intervention efficacy and level of exposure to the intervention, it is imperative to put effort in optimal dissemination. The present project attempts to optimize the dissemination process of a new online computer tailored generic lifestyle program by carefully studying the adoption process and developing a strategy to achieve sustained use of the program. METHODS/DESIGN: A prospective study will be conducted to yield relevant information concerning the adoption process by studying the level of adoption of the program, determinants involved in adoption and characteristics of adopters and non-adopters as well as satisfied and unsatisfied users. Furthermore, a randomized control trial will be conducted to the test the effectiveness of a proactive strategy using periodic e-mail prompts in optimizing sustained use of the new program. DISCUSSION: Closely mapping the adoption process will gain insight in characteristics of adopters and non-adopters and satisfied and unsatisfied users. This insight can be used to further optimize the program by making it more suitable for a wider range of users, or to develop adjusted interventions to attract subgroups of users that are not reached or satisfied with the initial intervention. Furthermore, by studying the effect of a proactive strategy using period prompts compared to a reactive strategy to stimulate sustained use of the intervention and, possibly, behaviour change, specific recommendations on the use and the application of prompts in online lifestyle interventions can be developed. TRIAL REGISTRATION: Dutch Trial Register NTR1786 and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016).

Testing a Dutch web-based tailored lifestyle programme among adults: a study protocol.

BACKGROUND: Smoking, high alcohol consumption, unhealthy eating habits and physical inactivity often lead to (chronic) diseases, such as cardiovascular diseases and cancer. Tailored online interventions have been proven to be effective in changing health behaviours. The aim of this study is to test and compare the effectiveness of two different tailoring strategies for changing lifestyle compared to a control group using a multiple health behaviour web-based approach. METHODS: In our Internet-based tailored programme, the five lifestyle behaviours of smoking, alcohol intake, fruit consumption, vegetable consumption, and physical activity are addressed. This randomized controlled trial, conducted among Dutch adults, includes two experimental groups (i.e., a sequential behaviour tailoring condition and a simultaneous behaviour tailoring condition) and a control group. People in the sequential behaviour tailoring condition obtain feedback on whether their lifestyle behaviours meet the Dutch recommendations. Using a step-by-step approach, they are stimulated to continue with a computer tailored module to change only one unhealthy behaviour first. In the course of the study, they can proceed to change a second behaviour. People in the simultaneous behaviour tailoring condition receive computer tailored feedback about all their unhealthy behaviours during their first visit as a stimulation to change all unhealthy behaviours. The experimental groups can re-visit the website and can then receive ipsative feedback (i.e., current scores are compared to previous scores in order to give feedback about potential changes). The (difference in) effectiveness of the different versions of the programme will be tested and compared to a control group, in which respondents only receive a short health risk appraisal. Programme evaluations will assess satisfaction with and appreciation and personal relevance of the intervention among the respondents. Finally, potential subgroup differences pertaining to gender, age and socioeconomic status regarding the behaviour effects and programme evaluation will be assessed. DISCUSSION: Research regarding multiple behaviour change is in its infancy. We study how to offer multiple behaviour change interventions optimally. Using these results could strengthen the effectiveness of web-based computer-tailoring lifestyle programmes. This study will yield new results about the need for differential lifestyle approaches using Internet-based expert systems and potential differences in subgroups concerning the effectiveness and appreciation. TRIAL REGISTRATION: Dutch Trial Register NTR2168.