Strength exercises during physical education classes in secondary schools improve body composition: a cluster randomized controlled trial.

BACKGROUND: Metabolic health in people with obesity is determined by body composition. In this study, we examined the influence of a combined strength exercise and motivational programme -embedded in the school curriculum- on adolescents body composition and daily physical activity. METHODS: A total of 695 adolescents (11-15y) from nine Dutch secondary schools participated in a one year cluster randomised controlled trial (RCT). In the intervention schools, physical education teachers were instructed to spend 15-30 min of all physical education lessons (2× per week) on strength exercises. Monthly motivational lessons were given to stimulate students to be more physically active. Control schools followed their usual curriculum. The primary outcome measure was body composition assessed by the deuterium dilution technique. Daily physical activity and sedentary behaviour measured by accelerometry served as a secondary outcome. RESULTS: After 1 year, a 1.6% fat mass difference was found in favour of the intervention group (p = .007). This reflected a 0.9 kg difference in fat free mass (intervention>control; p = .041) and 0.7 kg difference in fat mass (intervention

Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study).

BACKGROUND: Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. METHODS: In this multicentre double-blind RCT, patients (aged 18-80 years with a BMI of 18-35 kg/m2 and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery. RESULTS: Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3-5) days for OLLS versus 3 (3-3) days for LLLS; and 3 (3-3) days for ONR versus 3 (3-4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates. CONCLUSION: This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 ( https://www.clinicaltrials.gov).

Individual support plans of people with intellectual disabilities in residential services: content analysis of goals and resources in relation to client characteristics.

BACKGROUND: Goals and objectives as mentioned in Individual Support Plans (ISPs) were analysed to explore what domains of quality of life they are associated with, what support resources are referenced for achieving the goals, and how domains and resources are related to clients age, gender and intellectual disability (ID) level. METHOD: A total of 209 ISPs for persons with ID from eight residential Dutch service provider organisations were analysed. Mixed linear regression analyses were conducted to examine the relations between client characteristics and the content of goals and support resources. RESULTS: Results showed that ISPs of people with mild and moderate ID had significantly more goals related to independence and social participation as compared to the ISPs of people with severe and profound ID. ISPs of clients with profound ID addressed quality of life factors related to 'well-being' more than ISPs of all other clients. ISPs of people aged 20-34 years had significantly more goals on independence than the two other age groups. ISPs of people under the age of 50 had significantly fewer goals with respect to well-being than found in ISPs of older people. Regarding the use of resources, 42.6% of the ISP goals were associated with resources from specialised services, 31.5% associated with natural resources and 25.9% associated with a combination of both natural and specialised services. In ISPs of people with mild ID, natural resources are more often mentioned, and specialised service-based resources are less often mentioned than for other people. CONCLUSIONS: This study offers empirical feedback on ISP practices in the field of ID in the Netherlands. In light of current ISP practices, results suggest that attention should be paid to: (1) distinguishing between a 'service contract' and an ISP; (2) keeping a focus on the whole person in all age groups and levels of functioning and (3) involving the service recipient in ISP development and implementation.

Development of a composite endpoint for randomized controlled trials in liver surgery.

BACKGROUND: The feasibility of randomized controlled trials (RCTs) in liver surgery using a single-component clinical endpoint is low as such endpoints require large sample sizes owing to their low incidence. A liver surgery-specific composite endpoint (CEP) could solve this problem. The aim of this study was to develop a liver surgery-specific CEP with well-defined components. METHODS: Components of a liver surgery-specific CEP were selected based on a systematic literature search and consensus among 28 international hepatopancreatobiliary (HPB) surgeons. As an example, two prospective cohorts of patients who had undergone liver surgery in high-volume HPB centres were used to assess the event rate and effect of implementing a liver surgery-specific CEP. RESULTS: Components selected for the liver surgery-specific CEP were ascites, postresectional liver failure, bile leakage, intra-abdominal haemorrhage, intra-abdominal abscess and operative mortality, all with a Clavien-Dindo grade of at least 3 and occurring within 90 days after initial surgery. The incidence of this liver surgery-specific CEP was 19.2 per cent in one cohort and 10.7 per cent in the other. These rates led to an approximately twofold reduction in the theoretical sample size required for an adequately powered RCT in liver surgery using the CEP as primary endpoint. CONCLUSION: The proposed liver surgery-specific CEP consists of ascites, postresectional liver failure, bile leakage, intra-abdominal haemorrhage, intra-abdominal abscess and operative mortality. It has a considerably higher event rate than any of its components. Its use as the primary endpoint will increase the feasibility and comparability of RCTs in liver surgery.

Feasibility of randomized controlled trials in liver surgery using surgery-related mortality or morbidity as endpoint.

BACKGROUND: There is a shortage of randomized controlled trials (RCTs) on which to base guidelines in liver surgery. The feasibility of conducting an adequately powered RCT in liver surgery using the dichotomous endpoints surgery-related mortality or morbidity was examined. METHODS: Articles published between January 2002 and November 2007 with mortality or morbidity after liver surgery as primary endpoint were retrieved. Sample size calculations for a RCT aiming to show a relative reduction of these endpoints by 33, 50 or 66 per cent were performed. RESULTS: The mean operative mortality rate was 1.0 per cent and the total morbidity rate 28.9 per cent; mean rates of bile leakage and postresectional liver failure were 4.4 and 2.6 per cent respectively. The smallest numbers of patients needed in each arm of a RCT aiming to show a 33 per cent relative reduction were 15 614 for operative mortality, 412 for total morbidity, 3446 for bile leakage and 5924 for postresectional liver failure. CONCLUSION: The feasibility of conducting an adequately powered RCT in liver surgery using outcomes such as mortality or specific complications seems low. Conclusions of underpowered RCTs should be interpreted with caution. A liver surgery-specific composite endpoint may be a useful and clinically relevant solution to pursue.

The environment influences whether high-fat foods are associated with palatable or with unhealthy.

This study investigated whether relatively automatic evaluations of food differ between situations and between obese people and lean controls. These evaluations were assessed in the affective priming paradigm (APP) -- a response latency based measure for associations. In Experiment 1, we either focused participants (33 obese and 26 lean controls) on the palatability (restaurant condition) or on the healthiness (health condition) of food, prior to the APP. Independent of weight-status, relatively automatic evaluations of food were based on palatability in the restaurant condition, and on health in the health condition. So, the current focus of attention can shape the way foods are evaluated relatively automatically. In Experiment 2, craving was induced in participants (27 obese and 29 lean controls). Unexpectedly, the craving induction did not achieve its goal of focusing on the palatability of food in general, but just for low-fat foods, possibly because of the health-emphasizing environment -- a hospital. Interestingly, obese people showed a stronger palatability priming effect with increasing levels of initial craving. For normal weight controls the effect was in the same direction, but missed significance. In our environment, palatability of food may be too salient, and health may not be salient enough, influencing automatic food-evaluations.

[Effectiveness of the Assessment of Burden of COPD tool: a cluster-randomised controlled trial]. / Effectiviteit van de 'Ziektelastmeter COPD'.

OBJECTIVE: Assessment of the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD). DESIGN: Cluster-randomised controlled trial. METHOD: This concerned a trial in 39 Dutch primary care practices and 17 hospitals, involving 357 patients with COPD (postbronchodilator FEV1/FVC ratio < 0.7) aged ≥ 40 years. Healthcare providers were randomized to an intervention or control group. Patients in the intervention group were treated with the ABC tool. This innovative tool consists of a short validated questionnaire and a number of objective parameters, which collectively give a visual overview of the combined integral health; the tool subsequently produces an individualized treatment plan by means of a treatment algorithm. Patients in the control group received usual care. The primary outcome measure was the proportion of patients with a clinically relevant improvement in disease-specific quality of life measured, as measured by means of the St. George's Respiratory Questionnaire (SGRQ) score, between baseline and 18 months follow-up. Secondary outcomes included the SGRQ total score and the Patient Assessment of Chronic Illness Care (PACIC) score. RESULTS: At 18-month follow-up, a significant and clinically relevant improvement in the SGRQ score was seen in 34% of the patients (N=49) in the intervention group, and in the control group this figure was 22% (N=33). This difference between the two groups was significant (OR 1.85, 95% CI 1.08 to 3.16). Patients in the intervention group experienced a higher quality of care than patients in the control group (0.32 points difference in PACIC, 95% CI 0.14 to 0.50). CONCLUSION: Use of the ABC tool increases the disease-specific quality of life and the quality of care for COPD patients; it may therefore offer a valuable contribution to improvements in the daily care of COPD. Replication of this study in other (non-Dutch) health-care settings is recommended.

Tailoring information to enhance quitting in smokers with low motivation to quit: three basic efficacy questions.

Tailoring information to a target individual's features is a promising line of development in self-help interventions. In this article, 752 smokers with explicit low intention to quit were randomly assigned to 1 of 5 conditions: (a) multiple tailored letters with self-help guide, (b) multiple tailored letters only, (c) a single tailored letter with a self-help guide, (d) a single tailored letter only, or (e) a nontailored intervention. Follow-up assessment took place 4 months after the intervention. Results indicated that the single tailored intervention only had no surplus value compared with a nontailored look-alike intervention. The addition of a self-help guide to a tailored intervention was only useful in highly dependent smokers, and multiple tailoring was more effective than single tailoring. It remains important to elucidate why and for whom certain tailored interventions are more effective.

Tailored interventions to communicate stage-matched information to smokers in different motivational stages.

Smokers in stages of low readiness to quit (immotives and precontemplators) and smokers in stages of high readiness to quit (contemplators and preparers) were randomly allocated to 1 of 4 tailored intervention conditions offering outcome information, self-efficacy-enhancing information, both sorts of information, or no information. Data on 1,540 smokers, stratified by stage, were analyzed. The primary outcome measure was stage transition. The hypotheses with regard to stage-matched information for immotives and precontemplators were not verified. With regard to contemplators and preparers, the following was found: Compared with the control group, contemplators benefited the most from both sorts of information, whereas preparers benefited the most from self-efficacy-enhancing information only. Comparisons between contemplators and preparers who were assigned to the matched treatment and contemplators and preparers who were assigned to the mismatched treatment supported these findings.

Chronic low-back pain: what does cognitive coping skills training add to operant behavioral treatment? Results of a randomized clinical trial.

This study examined the supplemental value of a cognitive coping skills training when added to an operant-behavioral treatment for chronic low-back pain patients. The complete treatment package (OPCO) was compared with an operant program + group discussion (OPDI) and a waiting-list control (WLC). After the WL period, the WLC patients received a less protocolized operant program usually provided in Dutch rehabilitation centers (OPUS). Regression analyses showed that, compared with WLC, both OPCO and OPDI led to less negative affect, higher activity tolerance, less pain behavior, and higher pain coping and pain control. At posttreatment, OPCO led to better pain coping and pain control than OPDI. Calculation of improvement rates revealed that OPCO and OPDI had significantly more improved patients than OPUS on all the dependent variables. The discussion includes findings regarding treatment credibility, compliance, and contamination bias.

Behavioral risk factors of sudden cardiac arrest.

OBJECTIVE: The purpose of this study was to investigate the association between sudden cardiac arrest (SCA) and the behavioral factors exhaustion and nonexpression of emotions. METHODS: Case-control study of 99 victims of SCA and 119 coronary controls, matched for gender and age. RESULTS: Victims of SCA were more often assessed as exhausted and as closed by their family members than controls. A significant interaction between exhaustion and closeness on the risk of SCA was observed. Those who were exhausted and did not express their emotions had a sevenfold greater risk of SCA. CONCLUSION: The behavioral factor of exhaustion and nonexpression of emotions may contribute to the identification of persons at elevated risk for SCA.

Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain.

The aim of this investigation was to examine the effectiveness of a graded exposure in vivo treatment with behavioural experiments as compared to usual graded activity in reducing pain-related fears, catastrophising and pain disability in chronic low back pain patients reporting substantial fear of movement/(re)injury. Included in the study were four consecutive CLBP patients who were referred for outpatient behavioural rehabilitation, and who reported substantial fear of movement/(re)injury (Tampa Scale for Kinesiophobia score>40). A replicated single-case cross-over design was used. After a no-treatment baseline measurement period, the patients were randomly assigned to one of two interventions. In intervention A, patients received the exposure first, followed by graded activity. In intervention B, the sequence of treatment modules was reversed. Sixty-three daily measures of pain-related cognitions and fears were recorded with visual analogue scales. Before and after the treatment, the following measures were taken: pain-related fear, pain catastrophising, pain control and pain disability. Using time series analysis on the daily measures of pain-related cognitions and fears, we found that improvements only occurred during the graded exposure in vivo, and not during the graded activity, irrespective of the treatment order. Analysis of the pre-post treatment differences also revealed that decreases in pain-related fear concurred with decreases in pain catastrophising and pain disability, and in half of the cases an increase in pain control. This study shows that the external validity of exposure in vivo also extends to the subgroup of chronic low back pain patients who report substantial fear of movement/(re)injury.

Psychometric properties of the Multidimensional Pain Inventory, Dutch language version (MPI-DLV).

The purpose of this study was to investigate the psychometric properties of a Dutch translation of the Multidimensional Pain Inventory, MPI-DLV. Data was available on 733 chronic pain patients. There were three issues of special interest. The first one related to the comparability between the MPI-DLV and the American and German MPI versions with regard to the psychometric aspects. The second dealt with the construct validity of the MPI-DLV scale 'general activity'. It was predicted that patients with high scores on this scale would be in better physical condition, as measured on a working-to-tolerance bicycle ergometer test. In relation to the third issue, attention was given to the factor-invariance between fibromyalgia patients and back pain patients. From the results obtained it was concluded that (1) the factorial structure of the three MPI parts is replicated and the reliability estimates and validity indicators are similar to those from the American and German versions; (2) patients with high scores on the 'general activity' scale are in better physical condition and (3) MPI-DLVs of fibromyalgia and back pain patients do have similar factorial structures. Evidence was also obtained that the MPI-DLV is sensitive to treatment changes. Applications of the MPI-DLV are discussed.

Long-term effectiveness of two Dutch work site smoking cessation programs.

This article reports on one of the few experimental studies in Europe to examine work site smoking cessation. The study examined whether a comprehensive intervention (self-help manuals, group courses, a mass media campaign, smoking policies, and a second-year program) is more effective than a minimal intervention (self-help manuals only). Eight work sites participated in the study. The effect of treatment on smoking cessation depended on nicotine dependency levels: Heavy smokers had more success with the comprehensive smoking cessation intervention than with the minimal intervention (with respect to both 14-month quit rate and 6-month prolonged abstinence). For heavy smokers, exposure to mass media exhibitions or to group courses had a beneficial effect on prolonged abstinence. Comprehensive programs may be most appropriate in Dutch work sites with large proportions of heavily addicted smokers.

The impact of computer-tailored feedback and iterative feedback on fat, fruit, and vegetable intake.

A randomized trial was conducted to study the impact of individualized computer-generated nutrition information and additional effects of iterative feedback on changes in intake of fat, fruits, and vegetables. Respondents in the experimental group received computer-generated feedback letters tailored to their dietary intake, intentions, attitudes, self-efficacy expectations, and self-rated behavior. After the first feedback letter, half of the experimental group received additional iterative feedback tailored to changes in behavior and intentions. The control group received a single general nutrition information letter in a format similar to the tailored letters. Computer-tailored feedback had a significantly greater impact on fat reduction and fruit and vegetable intake than did general information. Iterative computer-tailored feedback had an additional impact on fat intake. The results confirm that computer-generated individualized feedback can be effective in inducing recommended dietary changes and that iterative feedback can increase the longer term impact of computer-tailored nutrition education on fat reduction.

[Roaming through methodology. XXI. How to arrive at a weighed total score of separate items of a questionnaire]. / Dwalingen in de methodologie. XXI. Hoe te komen tot een gewogen totaalscore van afzonderlijke scores op een vragenlijst.

In medical research the responses of patients to a number of items are often combined into a summary measure or total score for a more general patient characteristic, such as mobility. Clinical and statistical criteria exist for determining the weight of each question in the total score. The choice of weights may affect the differences between patients. The total score is often analysed statistically as if it had interval level of measurement, thereby allowing conclusions about the size of differences between patients, but it has merely an ordinal level. The incorrectness of the interval assumption may also affect differences between patients or patient groups. Finally, differences between patients are less dependent on the weighting of the items and on the assumption of an interval scale as the total score is based on more homogeneous items. Standard statistical software contains statistical methods for determining the homogeneity as well as the weights.

Smoking among Dutch elementary schoolchildren: gender-specific predictors.

Higher rates of smoking initiation and continuation by female compared with male adolescents, as found in many developed countries, may call for gender-specific prevention programs. Risk factors of smoking initiation and continuation were examined prospectively (1997-2002) among 3205 Dutch elementary schoolchildren (mean age 11.64) in an intervention trial using written questionnaires and multilevel logistic regression. At baseline, smoking prevalence was lower among girls than among boys; at follow-up, smoking initiation was lower among girls than among boys. Concerning smoking initiation, girls and boys shared the following risk factors: age, modeling from parents and siblings ('modeling nuclear'), modeling from other members in the social circle ('modeling diffuse') and perceived pro-tobacco pressure to smoke. The only gender-specific predictor of smoking initiation was parent origin; girls with non-Dutch parents could be targeted for prevention programs. Concerning continuation, girls and boys shared the following risk factors: older age, more modeling nuclear and diffuse, fewer smoking disadvantages and lower self-efficacy to refrain from smoking. This study confirms that social modeling, smoking attitude and self-efficacy information to refrain from smoking deserve a prominent place in smoking prevention programs for schoolchildren. Besides booster sessions, family-directed programs are suggested. No gender-specific predictors of later smoking initiation were found, apart from parent origin, which is not amenable to intervention.

Determinants of intention to quit smoking among Dutch employees: the influence of the social environment.

BACKGROUND: This study examines the influence of the social environment in worksites on employees' intention to quit smoking by applying the attitude-social influence-efficacy model. METHODS: Regression analyses were conducted with 509 smoking employees from eight Dutch worksites. Variables of interest were attitudes toward smoking, perceived social pressure to quit, perceived smoking behavior of others, self-efficacy, demographics, smoking history variables, company type, and smoking tolerance. RESULTS: Attitude, social pressure from people out-side the worksetting (partner, children), and self-efficacy explained 23% of the variance for intention. Past behavior increased the adjusted R2 from 0.23 to 0.29. Social influences in the worksite were unrelated to employees' intention to quit smoking. CONCLUSIONS: It was concluded that, in Dutch work-sites, social influences stemming from people at work have less influence on employees' intention to quit smoking than other important people outside the work situation. Implications for smoking control strategies in worksites are briefly discussed.

Remembering the street names of one's childhood neighbourhood: a study of very long-term retention.

Life-span retention of street names was studied in a sample of former students of a Dutch elementary school. Participants were requested to recall the street names of their childhood neighbourhood and indicate their position on a map. In addition, information was gathered concerning (a) the extensiveness of the original learning experience, (b) its elaborateness, and (c) the amount of interference from similar materials occurring between original learning experience and time of recall. Retention intervals varied from 0 to 71 years. Amount of exposure, elaborateness of learning, and retroactive interference all contributed to the memorability of names. In addition, the forgetting curve showed a permastore effect (Bahrick, 1984), suggesting that memory for non-schematic, incidentally learned material is subject to processes of forgetting similar to those that affect intentionally learned material, such as subject-matter acquired in school.

Effectiveness of a social influence approach and boosters to smoking prevention.

This paper presents the short-term and long-term results of a randomized smoking prevention trial. The purpose was to evaluate two smoking prevention programs, a social influence (SI) program and a SI program with an additional decision-making component (SI(DM)). Moreover, the contribution of boosters was assessed as well. Fifty-two schools were randomly assigned to the SI program, the SI(DM) program or a control group. Half of the treatment schools were randomly assigned to the booster condition; the other half did not receive boosters. Both programs consisted of five lessons, each lasting 45 min, and were given in weekly sessions in grades 8 and 9 of high schools in the Netherlands. The most successful program was the SI program with boosters which resulted in a significantly lower increase in smoking rates (5.6 and 9.7%, respectively) compared to the control group (12.6 and 14.9%, respectively) at both 12 and 18 months follow-up. The results suggest that boosters can be an effective tool for maintaining or increasing the effectiveness of smoking prevention programs. It is recommended that the SI program with the booster be implemented at the national level, since this intervention showed the greatest behavioral effects.