The added value of frequent physical activity group sessions in a combined lifestyle intervention: A cluster randomised trial in primary care.

Combined lifestyle interventions (CLIs) that target both physical activity (PA) and diet have been shown to improve PA and health of adults who are overweight; however, optimal amount of guidance remains unclear. This study evaluated the effects of adding PA group sessions to a standard CLI in primary care in the Netherlands. 411 participants (BMI 34.5 ± 4.4 kg/m2) in thirty locations were randomised into a one year CLI or CLI+. CLI comprised individual meetings with lifestyle coach (LSC) and physiotherapist, and group meetings with dietician. PA group sessions were added in CLI+. Primary outcome was minutes of moderate to vigorous PA per week. Secondary outcomes of PA, diet and cardiovascular risk factors (i.e. waist circumference, HbA1c and blood pressure) were evaluated after 12 and 24 months with multilevel analyses. Data were collected from 2010 to 2015. Significant between-group effects were only found for waist circumference, which was significantly lower at twelve months in the CLI+ group (p = 0.011), no other between-group differences were found. Several within-group changes were significant. After participating in the intervention, walking time increased with 83 ± 35 min/week and 100 ± 38 min/week, and BMI decreased with 0.7 ± 0.3 kg/m2 and 1.5 ± 0.3 kg/m2 in CLI and CLI+ respectively (p < 0.001). Diet, HbA1c and systolic blood pressure changed favourably in both groups. Adding PA group sessions did not elicit added, sustained benefits. A programme with individual meetings with LSC and physiotherapist, and group meetings with dietician can be sufficient to facilitate a healthy lifestyle and reduce cardiovascular risk factors in a population with overweight.

Physical health status of older adults with severe mental illness: The PHiSMI-E cohort study.

The objective was to use various somatic parameters as basis for investigating the physical health of older adults with severe mental illnesses (SMI). A cross-sectional study design is performed by using baseline data from the Physical Health in SMI-elderly (PHiSMI-E) study. Data were collected using the Nursing Monitoring of Somatic Status and Lifestyle - Mental Health instrument in adults aged over 60 with SMI in a large Dutch mental health institute. Ninety-nine elderly SMI patients were included. Somatic comorbidity (84.8%), use of somatic medication (77.7%) and polypharmacy (67.7%) were prevalent. Extrapyramidal symptoms were experienced by 51% of patients, mainly in the subgroup with psychotic disorders (75.6%). Unhealthy diet was reported in 16.2%, obesity in 27.3%, and physical inactivity in 57.6%. Fatigue (67.7%) and dry mouth (66.6%) were the commonest reported physical symptoms. Mean VAS score (scale 0-10) indicating participants' self-perceived physical health was 6.7 (SD ± 1.6). After division of the total patient group into tertiles based on the VAS scores, the lowest tertile was characterized by less physical activity, unhealthier diet, more use of medication, more fatigue, somnolence, and inner agitation. In conclusion, impaired physical health status was common in these older patients with SMI. Although they had more psychiatric and somatic comorbidity than adult SMI patients described in the literature, they had a healthier lifestyle. To reduce morbidity and premature mortality in these frail patients, it is essential that healthcare providers are aware of the high prevalence of somatic comorbidity and symptoms, and of their interactions with the psychiatric disorders. This study improves our understanding of differences in vulnerability factors of older patients with SMI. The (early) detection of somatic comorbidities may improve long-term health outcomes of these patients.

Evaluation of a combined lifestyle intervention for overweight and obese patients in primary health care: a quasi-experimental design.

BACKGROUND: Combined lifestyle interventions (CLIs) are designed to reduce risk factors for lifestyle-related diseases through increasing physical activity and improvement of dietary behaviour. OBJECTIVE: To evaluate the effects of a CLI for overweight and obese patients on lifestyle-related risk factors and health care consumption, in comparison to usual care. METHODS: Data on anthropometric and metabolic measurements, morbidity, drugs prescriptions and general practitioner (GP) consultations were extracted from electronic health records (timeframe: July 2009-August 2013). Using a quasi-experimental design, health outcomes of 127 patients who participated in a 1-year CLI were compared to a group of 254 matched patients that received usual care. Baseline to post-intervention changes in health outcomes between intervention and comparison group were evaluated using mixed model analyses. RESULTS: Compared to baseline, both groups showed reductions in body mass index (BMI), blood pressure, total cholesterol and low density lipoprotein cholesterol in year post-intervention. For these outcome measures, no significant differences in changes were observed between intervention and comparison group. A significant improvement of 0.08 mmol/l in high density lipoprotein (HDL) cholesterol was observed for the intervention group above the comparison group (P < 0.01). No significant intergroup differences were shown in drugs prescriptions and number of GP consultations. CONCLUSION: A CLI for overweight and obese patients in primary health care resulted in similar effects on health outcomes compared to usual care. Only an improvement on HDL cholesterol was shown. This study indicates that implementation and evaluation of a lifestyle intervention in primary health care is challenging due to political and financial barriers.

The implementation and sustainability of a combined lifestyle intervention in primary care: mixed method process evaluation.

BACKGROUND: The impact of physical inactivity and unhealthy diet on health is increasingly profound. Lifestyle interventions targeting both behaviors simultaneously might decrease the prevalence of overweight and comorbidities. The Dutch 'BeweegKuur' is a combined lifestyle intervention (CLI) in primary care, to improve physical activity and dietary behavior in overweight people. In a cluster randomized controlled trial, the (cost-) effectiveness of an intensively guided program has been compared to a less intensively guided program. This process evaluation aimed to assess protocol adherence and potential differences between clusters. In addition, sustainability (i.e. continuation of the CLI in practice after study termination) was evaluated. METHODS: Existing frameworks were combined to design the process evaluation for our intervention and setting specifically. We assessed reach, fidelity, dose delivered and received, context and implementation strategy. Both qualitative and quantitative data were used for a comprehensive evaluation. Data were collected in semi-structured interviews with health care providers (HCPs, n = 25), drop-out registration by HCPs, regular questionnaires among participants (n = 411) and logbooks kept by researchers during the trial. RESULTS: Protocol adherence by professionals and participants varied between the programs and clusters. In both programs the number of meetings with all HCPs was lower than planned in the protocol. Participants of the supervised program attended, compared to participants of the start-up program, more meetings with physiotherapists, but fewer with lifestyle advisors and dieticians. The 'BeweegKuur' was not sustained, but intervention aspects, networks and experiences were still utilized after finalization of the project. Whether clusters continued to offer a CLI seemed dependent on funding opportunities and collaborations. CONCLUSIONS: Protocol adherence in a CLI was problematic in both HCPs and participants. Mainly the amount of dietary guidance was lower than planned, and decreased with increasing guidance by PT. Thus, feasibility of changing physical activity and dietary habits simultaneously by one intervention in one year was not as high as expected. Also the sustainability of CLI was poor. When a CLI program is started, re-invention should be allowed and maximum effort should be taken to guarantee long term continuation, by planning both implementation and sustainability carefully. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46574304 . Registered 23 December 2010.

Reducing disability in community-dwelling frail older people: cost-effectiveness study alongside a cluster randomised controlled trial.

BACKGROUND: although proactive primary care, including early detection and treatment of community-dwelling frail older people, is a part of the national healthcare policy in several countries, little is known about its cost-effectiveness. OBJECTIVE: to evaluate the cost-effectiveness of a proactive primary care approach in community-dwelling frail older people. DESIGN AND SETTING: embedded in a cluster randomised trial among 12 Dutch general practitioner practices, an economic evaluation was performed from a societal perspective with a time horizon of 24 months. METHOD: frail older people in the intervention group received an in-home assessment and interdisciplinary care based on a tailor-made treatment plan and regular evaluation and follow-up. Practices in the control group delivered usual care. The primary outcome for the cost-effectiveness and cost-utility analysis was disability and health-related quality of life, respectively. RESULTS: multilevel analyses among 346 frail older people showed no significant differences between the groups regarding disability and health-related quality of life at 24 months. People in the intervention group used, as expected, more primary care services, but there was no decline in more expensive hospital and long-term care. Total costs over 24 months tended to be higher in the intervention group than in the control group (€26,503 versus €20,550, P = 0.08). CONCLUSIONS: the intervention under study led to an increase in healthcare utilisation and related costs without providing any beneficial effects. This study adds to the scarce amount of evidence of the cost-effectiveness of proactive primary care in community-dwelling frail older people. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN 31954692.

A 20 min window is optimal in a non-wear algorithm for tri-axial thigh-worn accelerometry in overweight people.

A valid non-wear algorithm for activity monitors is crucial to avoid the misclassification of sedentary time as non-wear time, and vice versa. Characteristics of the algorithm, such as time windows, should be well defined and tested. Furthermore, using tri-axial data might influence the algorithm's performance. This study assessed the optimal time window length in a non-wear algorithm for overweight adults, applied to tri-axial data from sixteen participants. Ten time windows, from 10 up to 120 min, were tested with a diary as a criterion measure. We assessed the bias in non-wear time, sensitivity and specificity. The optimal time window length was based on ten participants; the validation of this time window was carried out with six other participants. The time window of 20 min showed the highest and 120 min showed the lowest mean amount of correctly classified non-wear time, at 94% and 70% respectively. Sensitivity and specificity were considered optimal in the 20 min time window. Validation of this time window demonstrated a sensitivity and specificity of 86% and 83% respectively. A 20 min time window showed the best non-wear estimations. The current study utilized tri-axial raw data and 1 s epoch data which might have facilitated the application of a short time window and thereby decreased the risk of misclassifying non-wear.

The contribution of lifestyle coaching of overweight patients in primary care to more autonomous motivation for physical activity and healthy dietary behaviour: results of a longitudinal study.

BACKGROUND: Combined lifestyle interventions (CLIs) have been advocated as an effective instrument in efforts to reduce overweight and obesity. The odds of maintaining higher levels of physical activity (PA) and healthier dietary behaviour improve when people are more intrinsically motivated to change their behaviour. To promote the shift towards more autonomous types of motivation, facilitator led CLIs have been developed including lifestyle coaching as key element. The present study examined the shift in types of motivation to increase PA and healthy dieting among participants of a primary care CLI, and the contribution of lifestyle coaching to potential changes in motivational quality. METHODS: This prospective cohort study included participants of 29 general practices in the Netherlands that implemented a CLI named 'BeweegKuur'. Questionnaires including items on demographics, lifestyle coaching and motivation were sent at baseline and after 4 months. Aspects of motivation were assessed with the Behavioural Regulation and Exercise Questionnaire (BREQ-2) and the Regulation of Eating Behaviour Questionnaire (REBS). We performed a drop out analysis to identify selective drop-out. Changes in motivation were analysed with t-tests and effect size interpretations (Cohen's d), and multivariate regression analysis was used to identify predictors of motivational change. RESULTS: For physical activity, changes in motivational regulation were fully in line with the tenets of Self Determination Theory and Motivational Interviewing: participants made a shift towards a more autonomous type of motivation (i.e. controlled types of motivation decreased and autonomous types increased). Moreover, an autonomy supportive coaching style was generally found to predict a larger shift in autonomous types of motivation. For healthy dietary behaviour, however, except for a small decrease in external motivation, no favourable changes in different types of motivation were observed. The relation between coaching and motivation appeared to be influenced by the presence of physical activity guidance in the programme. CONCLUSIONS: Motivation of participants of a real life primary care CLI had changed towards a more autonomous motivation after 4 months of intervention. Autonomy-supportive lifestyle coaching contributed to this change with respect to physical activity. Lifestyle coaching for healthy diet requires thorough knowledge about the problem of unhealthy dieting and solid coaching skills.

Which activity monitor to use? Validity, reproducibility and user friendliness of three activity monitors.

BACKGROUND: Health is associated with amount of daily physical activity. Recently, the identification of sedentary time as an independent factor, has gained interest. A valid and easy to use activity monitor is needed to objectively investigate the relationship between physical activity, sedentary time and health. We compared validity and reproducibility of physical activity measurement and posture identification of three activity monitors, as well as user friendliness. METHODS: Healthy volunteers wore three activity monitors simultaneously: ActivPAL3, ActiGraphGT3X and CAM. Data were acquired under both controlled (n = 5) and free-living conditions (n = 9). The controlled laboratory measurement, that included standardized walking intensity and posture allocation, was performed twice. User friendliness was evaluated with a questionnaire. Posture classification was compared with direct observation (controlled measurement) and with diaries (free living). Accelerometer intensity accuracy was tested by correlations with walking speed. User friendliness was compared between activity monitors. RESULTS: Reproducibility was at least substantial in all monitors. The difference between the two CAM measurements increased with walking intensity. Amount of correct posture classification by ActivPAL3 was 100.0% (kappa 0.98), 33.9% by ActiGraphGT3X (kappa 0.29) and 100.0% by CAM (kappa 0.99). Correlations between accelerometer intensity and walking speed were 0.98 for ActivPAL3, 1.00 for ActiGraphGT3X and 0.98 for CAM. ICCs between activity monitors and diary were 0.98 in ActivPAL3, 0.59 and 0.96 in ActiGraphGT3X and 0.98 in CAM. ActivPAL3 and ActiGraphGT3X had higher user friendliness scores than the CAM. CONCLUSIONS: The ActivPAL3 is valid, reproducible and user friendly. The posture classification by the ActiGraphGT3X is not valid, but reflection of walking intensity and user friendliness are good. The CAM is valid; however, reproducibility at higher walking intensity and user friendliness might cause problems. Further validity studies in free living are recommended.

2014 consensus statement from the first Economics of Physical Inactivity Consensus (EPIC) conference (Vancouver).

This article describes major topics discussed from the 'Economics of Physical Inactivity Consensus Workshop' (EPIC), held in Vancouver, Canada, in April 2011. Specifically, we (1) detail existing evidence on effective physical inactivity prevention strategies; (2) introduce economic evaluation and its role in health policy decisions; (3) discuss key challenges in establishing and building health economic evaluation evidence (including accurate and reliable costs and clinical outcome measurement) and (4) provide insight into interpretation of economic evaluations in this critically important field. We found that most methodological challenges are related to (1) accurately and objectively valuing outcomes; (2) determining meaningful clinically important differences in objective measures of physical inactivity; (3) estimating investment and disinvestment costs and (4) addressing barriers to implementation. We propose that guidelines specific for economic evaluations of physical inactivity intervention studies are developed to ensure that related costs and effects are robustly, consistently and accurately measured. This will also facilitate comparisons among future economic evidence.

The Cost-Effectiveness of Measures to Prevent Recurrent Ankle Sprains: Results of a 3-Arm Randomized Controlled Trial.

BACKGROUND: Ankle sprains are the most common sports-related injury, associated with a high rate of recurrence and societal costs. Recent studies have emphasized the effectiveness of both neuromuscular training and bracing for the secondary prevention of ankle sprains. PURPOSE: To evaluate the cost-effectiveness of the separate and combined use of bracing and neuromuscular training for the prevention of the recurrence of ankle sprains. STUDY DESIGN: Economic and decision analysis; Level of evidence, 2. METHODS: A total of 340 athletes (157 male and 183 female; aged 12-70 years) who had sustained a lateral ankle sprain up to 2 months before inclusion were randomized to a neuromuscular training group (n = 107), brace group (n = 113), and combined intervention group (n = 120). Randomization was stratified by medical treatment of the inclusion sprain. Participants in the neuromuscular training group underwent an 8-week home-based exercise program. Participants in the brace group received a semirigid ankle brace to be worn during all sports activities for a period of 12 months. Participants allocated to the combined group underwent both interventions, with the ankle brace to be worn during all sports activities for a period of 8 weeks. The recurrence of ankle sprains and associated costs were registered during the 1-year follow-up. RESULTS: There were no differences between groups at baseline with regard to age, sex, sports participation, previous injury, or knowledge of preventive measures. The incremental cost-effectiveness ratio (ICER) of the brace group in comparison with the combined group was -€2828.30 (approximately--US$3865.00), based on a difference in the mean cost of -€76.16 (approximately--US$104.00) and a difference in the mean effects of 2.68%. The ICER of the neuromuscular training group in comparison with the combined group was €310.08 (approximately US$424.00), based on a difference in the mean cost of -€28.37 (approximately--US$39.00) and a difference in the mean effects of 9.15%. CONCLUSION: Bracing was found to be the dominant secondary preventive intervention over both neuromuscular training and the combination of both measures.

Cost-effectiveness of an intervention to reduce fear of falling.

OBJECTIVES: The aim of this study was to assess whether a multicomponent cognitive behavioral group intervention is preferable to usual care in terms of (healthcare) costs and effects on fear of falling and activity avoidance. METHODS: This economic evaluation was embedded in a randomized controlled trial among 540 community-living adults in the Netherlands, aged 70 years and older who reported fear of falling and fear-induced activity avoidance. The participants allocated to the intervention group received a multicomponent cognitive behavioral group intervention consisting of eight weekly sessions and a booster session. The sessions were aimed at instilling realistic views of falls, reducing fall risk, and increasing activity and safe behavior. Participants in the control group received usual care. Cost outcome measures were healthcare costs, and patient and family costs. Clinical outcomes were fear of falling and activity avoidance. All outcomes were assessed at baseline and at 2, 8, and 14 months by means of registration forms, self-administered questionnaires, and interviews by telephone. RESULTS: Participants were randomly allocated to intervention (n = 280) and control groups (n = 260). Costs for the intervention program were on average €276 per person. Total costs per person were comparable (€4,925 in intervention group and €4,828 in control group). Furthermore, favorable effects of the program were observed for fear of falling and activity avoidance. CONCLUSIONS: This study showed that the intervention program is preferable to usual care in terms of costs and effects. The program had comparable costs and significantly reduced fear of falling and associated activity avoidance among older community-living persons.

Continuous versus intermittent data collection of health care utilization.

BACKGROUND: In economic evaluations, participants have to report their health care utilization continuously during follow-up. To unburden participants, researchers often collect data intermittently (i.e., in at least 3 months a year). However, comparability of intermittent v. continuous data collection is unknown. Therefore, this study aimed to compare costs estimated with intermittent data collection of health care utilization with those based on continuous data collection. METHODS: We used continuous health care utilization data from a trial with 12 months of follow-up and simulated several intermittent data collection patterns. Then 3 imputation techniques--individual mean (IM), last observation carried forward (LOCF) and next observation carried backward (NOCB)--were used to estimate total annual costs. Estimated annual costs were compared with observed annual costs from continuous data collection both in the original sample and in 1000 bootstrap samples. RESULTS: Analyses showed that intermittent data collection using cost diaries may offer good estimates of the actual total annual health expenditures. However, estimations of groups of costs differ between data collection patterns and imputation methods. The best estimations of annual total costs and groups of costs were obtained by random cohort data collection, using 3 random cohorts, ensuring that at least a third of the participants were measuring costs each month, combined with IM imputation. Intermittent data collection of health expenditures carries a small risk of missing infrequent expensive events. CONCLUSIONS: Continuous cost data collection remains the first choice. However, if intermittent measurement is chosen, we recommend calculating annual costs from intermittent data collection in random cohorts, combined with IM imputation.

The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial.

BACKGROUND: Frailty among older people is related to an increased risk of adverse health outcomes such as acute and chronic diseases, disability and mortality. Although many intervention studies for frail older people have been reported, only a few have shown positive effects regarding disability prevention. This article presents the design of a two-arm cluster randomized controlled trial on the effectiveness, cost-effectiveness and feasibility of a primary care intervention that combines the most promising elements of disability prevention in community-dwelling frail older people. METHODS/DESIGN: In this study twelve general practitioner practices were randomly allocated to the intervention group (6 practices) or to the control group (6 practices). Three thousand four hundred ninety-eight screening questionnaires including the Groningen Frailty Indicator (GFI) were sent out to identify frail older people. Based on their GFI score (≥5), 360 participants will be included in the study. The intervention will receive an interdisciplinary primary care intervention. After a comprehensive assessment by a practice nurse and additional assessments by other professionals, if needed, an individual action plan will be defined. The action plan is related to a flexible toolbox of interventions, which will be conducted by an interdisciplinary team. Effects of the intervention, both for the frail older people and their informal caregivers, will be measured after 6, 12 and 24 months using postal questionnaires and telephone interviews. Data for the process evaluation and economic evaluation will be gathered continuously over a 24-month period. DISCUSSION: The proposed study will provide information about the usefulness of an interdisciplinary primary care intervention. The postal screening procedure was conducted in two cycles between December 2009 and April 2010 and turned out to be a feasible method. The response rate was 79.7%. According to GFI scores 29.3% of the respondents can be considered as frail (GFI ≥ 5). Nearly half of them (48.1%) were willing to participate. The baseline measurements started in January 2010. In February 2010 the first older people were approached by the practice nurse for a comprehensive assessment. Data on the effect, process, and economic evaluation will be available in 2012. TRIAL REGISTRATION: ISRCTN31954692.

Relationship between location and activity in injurious falls: an exploratory study.

BACKGROUND: Knowledge about the circumstances under which injurious falls occur could provide healthcare workers with better tools to prevent falls and fall-related injuries. Therefore, we assessed whether older persons who sustain an injurious fall can be classified into specific fall types, based on a combination of fall location and activity up to the moment of the fall. In addition, we assessed whether specific injurious fall types are related to causes of the fall, consequences of the fall, socio-demographic characteristics, and health-related characteristics. METHODS: An exploratory, cross-sectional study design was used to identify injurious fall types. The study population comprised 333 community-dwelling Dutch elderly people aged 65 years or over who attended an accident and emergency department after a fall. All participants received a self-administered questionnaire after being discharged home. The questionnaire comprised items concerning circumstances of the injurious fall, causes of the fall, consequences of the fall, socio-demographic characteristics and health-related characteristics. Injurious fall types were distinguished by analyzing data by means of HOMALS (homogeneity analysis by means of alternating least squares). RESULTS: We identified 4 injurious fall types: 1) Indoor falls related to lavatory visits (hall and bathroom); 2) Indoor falls during other activities of daily living; 3) Outdoor falls near the home during instrumental activities of daily living; 4) Outdoor falls away from home, occurring during walking, cycling, and shopping for groceries. These injurious fall types were significantly related to age, cause of the fall, activity avoidance and daily functioning. CONCLUSION: The face validity of the injurious fall typology is obvious. However, we found no relationship between the injurious fall types and severity of the consequences of the fall. Nevertheless, there appears to be a difference between the prevalence of fractures and the cause of the fall between the injurious fall types. Our data suggests that with regard to prevention of serious injuries, we should pay special attention to outdoor fallers and indoor fallers during lavatory visits. In addition, we should have special attention for causes of the fall. However, the conclusions reached in this exploratory analysis are tentative and need to be validated in a separate dataset.

Lessons learned from a multidisciplinary fall-prevention programme: the occupational-therapy element.

OBJECTIVE: To gain insight into the contribution of the occupational-therapy part of a multidisciplinary fall prevention programme towards the reduction of falls and functional decline. DESIGN: A descriptive and exploratory study. METHODS: Data were collected in the context of a randomized controlled trial that found no effect of a multidisciplinary fall prevention programme. The study population comprised 166 participants, two occupational therapists (OTs), and one official from each of the five participating municipalities. Data were collected on the recommendations arising from the OT part of the programme, the extent to which those recommendations were implemented and what OTs did to stimulate implementation of behaviour change. RESULTS: The occupational-therapy programme resulted in 457 recommendations; 65% of the recommendations regarding services and assistive devices were implemented. It took on average six months to implement recommended home modifications. Advice on behaviour change predominantly comprised recommendations to reduce risky behaviour. CONCLUSION: To improve the occupational-therapy programme more rapid implementation of recommendations is suggested. Second, participants should be supported to achieve recommended changes. Furthermore, occupational therapists should use theory-based techniques to stimulate behaviour change and use follow-up visits to promote maintenance of the desired behaviour.

Process factors explaining the ineffectiveness of a multidisciplinary fall prevention programme: a process evaluation.

BACKGROUND: Falls are a major health threat to older community-living people, and initiatives to prevent falls should be a public health priority. We evaluated a Dutch version of a successful British fall prevention programme. Results of this Dutch study showed no effects on falls or daily functioning. In parallel to the effect evaluation, we carried out a detailed process evaluation to assess the feasibility of our multidisciplinary fall prevention programme. The present study reports on the results of this process evaluation. METHODS: Our fall prevention programme comprised a medical and occupational-therapy assessment, resulting in recommendations and/or referrals to other services if indicated. We used self-administered questionnaires, structured telephone interviews, structured recording forms, structured face-to-face interviews and a plenary group discussion to collect data from participants allocated to the intervention group (n = 166) and from all practitioners who performed the assessments (n = 8). The following outcomes were assessed: the extent to which the multidisciplinary fall prevention programme was performed according to protocol, the nature of the recommendations and referrals provided to the participants, participants' self-reported compliance and participants' and practitioners' opinions about the programme. RESULTS: Both participants and practitioners judged the programme to be feasible. The programme was largely performed according to protocol. The number of referrals and recommendations ensuing from the medical assessment was relatively small. Participants' self-reported compliance as regards contacting their GP to be informed of the recommendations and/or referrals was low to moderate. However, self-reported compliance with such referrals and recommendations was reasonable to good. A large majority of participants reported they had benefited from the programme. CONCLUSION: The results of the present study show that the programme was feasible for both practitioners and participants. Main factors that seem to be responsible for the lack of effectiveness are the relatively low number of referrals and recommendations ensuing from the medical assessments and participants' low compliance as regards contacting their GP about the results of the medical assessment. We do not recommend implementing the programme in its present form in regular care. TRIAL REGISTRATION: ISRCTN64716113.

Lack of effectiveness of a multidisciplinary fall-prevention program in elderly people at risk: a randomized, controlled trial.

OBJECTIVES: To assess whether a pragmatic multidisciplinary fall-prevention program was more effective than usual care in preventing new falls and functional decline in elderly people. DESIGN: A two-group, randomized, controlled trial with 12 months of follow-up. SETTING: University hospital and home-based intervention, the Netherlands. PARTICIPANTS: Three hundred thirty-three community-dwelling Dutch people aged 65 and over who were seen in an emergency department after a fall. INTERVENTION: Participants in the intervention group underwent a detailed medical and occupational-therapy assessment to evaluate and address risk factors for recurrent falls, followed by recommendations and referral if indicated. People in the control group received usual care. MEASUREMENTS: Number of people sustaining a fall (fall calendar) and daily functioning (Frenchay Activity Index). RESULTS: Results showed no statistically significantly favorable effects on falls (odds ratio=0.86, 95% confidence interval (CI)=0.50-1.49) or daily functioning (regression coefficient=0.37, CI=-0.90 to 1.63) after 12 months of follow-up. CONCLUSION: The multidisciplinary fall-prevention program was not effective in preventing falls and functional decline in this Dutch healthcare setting. Implementing the program in its present form in the Netherlands is not recommended. This trial shows that there can be considerable discrepancy between the "ideal" (experimental) version of a program and the implemented version of the same program. The importance of implementation research in assessing feasibility and effectiveness of such a program in a specific healthcare setting is therefore stressed.

A multidisciplinary fall prevention program for elderly persons: a feasibility study.

Falling is a common problem among elderly people and has many negative consequences. In the Netherlands, there is a need for effective fall prevention interventions aimed at elderly persons with an increased risk of falling. For this reason, we adapted a successful British fall prevention program comprising a medical occupational therapy assessment to the Dutch health care setting. This article describes the adaptation of this program and a pilot study to assess its feasibility in Dutch health care according to the implementers of the intervention as well as the participants (n = 21). This study showed that the Dutch intervention protocol is feasible in Dutch health care for both participants and implementers of the program. However, minor refinement of the intervention is warranted to improve its feasibility. The structured approach to adapt and pretest an intervention protocol appeared to be essential when aiming to implement a complex intervention program in a different health care setting.

Cost-effectiveness of a multidisciplinary fall prevention program in community-dwelling elderly people: a randomized controlled trial (ISRCTN 64716113).

OBJECTIVES: Multidisciplinary and multifactorial interventions seem to be effective in preventing falls. We aimed to assess the cost-effectiveness of a multidisciplinary fall prevention program compared with usual Dutch healthcare in community-dwelling people 65 years of age or older who experienced a fall. METHODS: Cost-effectiveness and cost-utility analysis were performed from a societal perspective. Falls and healthcare utilization were continuously measured for 12 months. Daily functioning and quality of life were measured at baseline, after 4 and 12 months. Bootstrap analyses were performed to estimate uncertainty of the findings and sensitivity analysis to assess the generalizability of assumptions made. RESULTS: One hundred sixty-six participants were randomly allocated to the experimental group and 167 to the control group. The overall response rate was 74 percent. Healthcare and patient and family costs of both groups were comparable. Our analyses showed no effect of the intervention program on falls, daily functioning, or quality of life measures. CONCLUSIONS: The multidisciplinary intervention program to prevent falls was not cost-effective compared with usual care in the Netherlands. Notwithstanding our findings, however, falls still have an important impact on society and individuals in terms of costs and effects. Economic evaluations studying promising interventions to prevent falls, therefore, remain necessary.

Effectiveness and cost-effectiveness of a multidisciplinary intervention programme to prevent new falls and functional decline among elderly persons at risk: design of a replicated randomised controlled trial [ISRCTN64716113].

BACKGROUND: Falls are common among community-dwelling elderly people and can have a considerable impact on quality of life and healthcare costs. People who have sustained a fall are at greater risk of falling again.We replicated a British randomised controlled trial which demonstrated the effectiveness of a multidisciplinary intervention programme to prevent falls. The objective is to describe the design of a replication study evaluating a multidisciplinary intervention programme on recurrent falls and functional decline among elderly persons at risk. The study consists of an effect evaluation, an economic evaluation and a process evaluation. METHODS/DESIGN: The programme is aimed at community-dwelling elderly people aged 65 years or over who have visited an accident and emergency department (A&E department) or a general practitioners' cooperative (GP cooperative) because of a fall. The design involves a two-group randomised controlled trial. Participants are followed for twelve months after baseline. The intervention programme consists of a detailed medical and occupational therapy assessment with referral to relevant services if indicated. People in the control group receive usual care. The main outcome measures of the effect evaluation are number of falls and daily functioning. The economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention programme.