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Background: Reading comprehension is an interactive process. Yet, instructional needs are usually identified with isolated componential tests. This study examined whether a dynamic approach, in which componential abilities are measured within the same text and global text comprehension is facilitated via feedback, can help in understanding variation in children's reading comprehension. Objectives: With a pretest‐posttest control group design, componential abilities before and after feedback were related to growth in global text comprehension within the same text. Methods: At pretest, third to fifth graders read 30 short texts, each followed by one global text comprehension question. This was repeated at posttest, but additional questions were asked with feedback prior to each global text comprehension question. The vocabulary group received two vocabulary questions with feedback (n = 97). The vocabulary plus integration group received two vocabulary questions and one sentence‐integration question with feedback (n = 98). The control group (n = 98) only answered the global text comprehension questions. Results and Conclusion: Participants in the experimental conditions who needed feedback (i.e., lower‐skilled) experienced a decrease in global text comprehension, whereas this was not found for the control group and participants in the experimental groups who did not need feedback (i.e., higher‐skilled). There was also less decrease among those lower‐skilled participants who had profited from the feedback. Implications: It is concluded from explorative analyses that not feedback but the overall design caused the decrease. Conceptually, the dynamic approach is worth further research. Lay Description: What is already known about this topic: Reading comprehension is a complex interaction of several componential abilities at word level, sentence level, and text level (e.g., vocabulary and sentence‐integration).Instruction should adapt to the profile of strengths and weaknesses in componential abilities.Assessing componential abilities with isolated tests does not align with the interactive processes in reading comprehension.Measuring learning ability can help to identify children with low responsiveness to instruction. What this paper adds: Reading comprehension is profiled by asking questions on vocabulary, sentence‐integration, and global text comprehension for the same text in third to fifth graders (8–11 years olds).Feedback is provided after a mistake in a vocabulary and sentence‐integration question, and the feedback effect on global text comprehension is measured with a pretest‐posttest design.Children who receive feedback decrease in global text comprehension but children with higher skills in componential abilities decrease less.Explorative analyses and previous research indicate that the assessment design had a negative impact on performance, for example, via cognitive load, attention, self‐esteem, and motivation. Implications for practice and/or policy: Global text comprehension cannot always be facilitated by providing feedback on vocabulary and sentence‐integration within the same text.The design of the assessment and its influence on performance should be carefully considered by instructional designers, educators, and researchers, especially in case of young learners.It remains unclear from this study if facilitating global text comprehension via feedback with a dynamic approach is useful to understand variation in children's reading comprehension.The dynamic approach with a proper design may potentially still provide a useful insight in individual differences. [ABSTRACT FROM AUTHOR]

Background: Heavy cannabis use is associated with adverse physical and mental health effects. Despite available effective treatments, the majority of heavy cannabis users does not seek professional help. Web-based interventions can provide an alternative for cannabis users who are reluctant to seek professional help. Several web-based cannabis interventions are effective in reducing cannabis use; however, the effect sizes are typically small and attrition rates are typically high. This suggests that web-based programs can be an effective cannabis use intervention for some, while others may need additional substance use treatment after completing a web-based intervention. Therefore, it is important that web-based interventions do not solely focus on reducing cannabis use, but also on improving attitudes towards substance use treatment. The Screening Brief Intervention and Referral to Treatment (SBIRT) approach appears to be well suited for the purpose of reducing cannabis use and improving substance use treatment utilization. Based on the SBIRT approach-and based on cognitive behavioral therapy (CBT) and motivational interviewing (MI)-we developed the Internet-based cannabis reduction intervention ICan.Methods/design: This protocol paper presents the design of a randomized controlled trial (RCT) in which we evaluate the effectiveness of the ICan intervention compared to four online modules of educational information on cannabis in a sample of Dutch frequent cannabis users. The primary outcome measure is frequency of cannabis use. Secondary outcome measures include the quantity of cannabis used (grams), the attitudes towards seeking help and the number of participants who enter specialized treatment services for cannabis use-related problems.Discussion: To the best of our knowledge, ICan is the first Internet-based intervention for cannabis users that combines screening, a brief intervention-based on CBT and MI-and referral to treatment options.Trial Registration: The study is registered in the Netherlands Trial Register; identifier NL7668 . Registered on 17 April 2019. [ABSTRACT FROM AUTHOR]

Background: School absenteeism, including medical absenteeism, is associated with early school dropout and may result in physical, mental, social and work-related problems in later life. Especially at intermediate vocational education schools, high rates of medical absenteeism are found. In 2012 the Dutch intervention 'Medical Advice for Sick-reported Students' (MASS), previously developed for pre-vocational secondary education, was adjusted for intermediate vocational education schools. The aim of the study outlined in this paper is to evaluate the effectiveness of the MASS intervention at intermediate vocational education schools in terms of reducing students' medical absenteeism and early dropping out of school. Additionally, the extent to which biopsychosocial and other factors moderate the effectiveness of the intervention will be assessed.Methods: A controlled before-and-after study will be conducted within Intermediate Vocational Education schools. Schools are allocated to be an intervention or control school based on whether the schools have implemented the MASS intervention (intervention schools) or not (control schools). Intervention schools apply the MASS intervention consisting of active support for students with medical absenteeism provided by the school including a consultation with the Youth Health Care (YHC) professional if needed. Control schools provide care as usual. Data will be collected by questionnaires among students in both groups meeting the criteria for extensive medical absenteeism (i.e. 'reported sick four times in 12 school weeks or for more than six consecutive school days' at baseline and at 6 months follow-up). Additionally, in the intervention group a questionnaire is completed after each consultation with a YHC professional, by both the student and the YHC professional. Primary outcome measures are duration and cumulative incidence of absenteeism and academic performances. Secondary outcome measures are biopsychosocial outcomes of the students.Discussion: It is hypothesized that implementing the MASS intervention including a referral to a YHC professional on indication, will result in a lower level of medical absenteeism and a lower level of school drop outs among intermediate vocational education students compared to students receiving usual care. The study will provide insight in the effectiveness of the intervention as well as in factors moderating the intervention's effectiveness.Trial Registration: Nederlands Trial Register NTR5556. Date of clinical trial registration: 29-Oct-2015. [ABSTRACT FROM AUTHOR]

Background: Overweight youngsters are better in absolute strength exercises than their normal-weight counterparts; a physiological phenomenon with promising psychological impact. In this paper we describe the study protocol of the Dutch, school-based program 'Focus on Strength' that aims to improve body composition of 11-13 year old students, and with that to ultimately improve their quality of life.Methods: The development of this intervention is based on the Intervention Mapping (IM) protocol, which starts from a needs assessment, uses theory and empirical research to develop a detailed intervention plan, and anticipates program implementation and evaluation. This novel intervention targets first year students in preparatory secondary vocational education (11-13 years of age). Teachers are the program implementers. One part of the intervention involves a 30 % increase of strength exercises in the physical education lessons. The other part is based on Motivational Interviewing, promoting autonomous motivation of students to become more physically active outside school. Performance and change objectives are described for both teachers and students. The effectiveness of the intervention will be tested in a Randomized Controlled Trial in 9 Dutch high schools.Discussion: Intervention Mapping is a useful framework for program planning a school-based program to improve body composition and motivation to exercise in 11-13 year old adolescents by a "Focus on Strength".Trial Registration: NTR5676 , registered 8 February 2016 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Nonprofessional caregivers are highly important in the everyday life of patients with depression. Yet, they may experience increased levels of burden, stress, depression, and anxiety. Therefore, there is a need for interventions that relieve symptoms and are accessible and time-efficient. This paper describes the protocol of a pilot study to evaluate (1) the feasibility of an online self-management intervention, E-care 4 caregivers, for the nonprofessional caregiver of patients with depression, and (2) the initial effects of E-care 4 caregivers on psychological distress, subjective burden, symptoms of anxiety and depression, and quality of life.Methods/design: The study is a randomized controlled trial in which we are comparing the E-care 4 caregivers online intervention with a wait list control group. Eighty-four nonprofessional caregivers of patients with depression aged 18 years or older are being recruited from among the general population. Feasibility is determined by semistructured telephone interviews evaluating the subjects' satisfaction with the intervention and by using a questionnaire on the user-friendliness of the system. The primary outcome measure used to examine the initial effects of the intervention is psychological distress. Secondary outcome measures are subjective burden, symptoms of anxiety and depression, level of mastery, and quality of life. Assessments will be done at baseline and 6 weeks later. Statistical analysis of the effects of the intervention will be carried out on the basis of the intention-to-treat principle.Discussion: E-care 4 caregivers could potentially benefit nonprofessional caregivers, as well as patients and professionals indirectly.Trial Registration: Netherlands Trial Register identifier: NTR5268 . Registered on 30 June 2015. [ABSTRACT FROM AUTHOR]

Abstract: Abundant evidence over past decades shows that foods with added plant sterols and plant stanols lower serum LDL cholesterol concentrations. However, despite the overwhelming data, numerous scientific questions still remain. The objective of this paper is to summarize the considerations of 60 academic and industrial experts who participated in the scientific meeting in Maastricht, the Netherlands, on issues related to the health effects of plant sterols and plant stanols. The meeting participants discussed issues including efficacy profiling, heterogeneity in responsiveness, effects beyond LDL-C lowering, and food formulation aspects of plant sterol and stanol consumption. Furthermore, aspects related to the potential atherogenicity of elevated circulatory plant sterol concentrations were discussed. Until the potential atherogenicity of plant sterols is resolved, based on the results >200 clinical trials, the risk to benefit of plant sterol use is favorable. Evidence on these topics in plant sterol and plant stanol research was presented and used to reach consensus where possible. It was concluded that endpoint studies looking at plant sterol and plant stanol efficacy are needed, however, there was no clear opinion on the best marker and best design for such a study. Based on the current scientific evidence, plant sterols and plant stanols are recommended for use as dietary options to lower serum cholesterol. [Copyright &y& Elsevier]

According to Dutch Law, patients committing severe crimes justifying imprisonment of four years or more who cannot be held (fully) accountable for these acts can be sentenced to compulsory hospitalization in a specialized TBS hospital in the Netherlands. In the current paper, the effects of TBS treatment will be addressed in terms of recidivism numbers after termination of TBS treatment, as well as in behavioral changes that are observed during admission to TBS hospitals. Although these results offer some indirect support suggesting that TBS is effective, no randomized controlled trials had been conducted up until now that could confirm this. In the current study, preliminary results are reported from a multicenter randomized clinical trial on the effectiveness of Schema Therapy (ST) for hospitalized TBS patients with Antisocial, Borderline, Narcissistic, or Paranoid Personality Disorders, including those with high levels of psychopathy. Patients at seven TBS clinics were randomly assigned to receive three years of either ST or Treatment As Usual (TAU), and are being assessed on several outcome variables, such as recidivism risk (HCR-20, START), personality disorder symptoms (SIDP-IV, SNAP), and successful re-integration into the community. A three-year follow-up study will examine actual recidivism. One hundred and two patients are participating in the study. The preliminary findings from the first 30 patients to complete the three-year study suggest that ST is yielding better outcomes than TAU with regard to reducing recidivism risk and promoting re-entry into the community. These findings are not yet statistically significant, and thus need to be interpreted with caution until confirmed in our complete sample and follow up. However, they suggest that ST may be a promising treatment for offenders with personality disorders, including some psychopathic ones. [ABSTRACT FROM PUBLISHER]

Background: Previous studies showed that exercise in cancer patients is feasible and may reduce fatigue and improve physical fitness and quality of life. However, many previous studies had methodological weaknesses related to trial design, sample size, comparison group, outcome measures, short follow-up durations and programme content. Purpose: This paper aims to present the rationale and design of the clinical research subprogramme of the Alpe d'HuZes Cancer Rehabilitation (A-CaRe) programme. Method: A-CaRe Clinical Research includes four randomized controlled trials in patients: (a) after chemotherapy, (b) during chemotherapy, (c) after stem cell transplantation and (d) during childhood cancer. These trials compare high-intensity resistance and endurance exercise interventions with usual care or a waiting list control group. In two studies, a second intervention arm consisting of low-to-moderate intensity exercise is included. All four A-CaRe trials use similar methods. Results: Outcome measures are carefully chosen based on the International Classification of Functioning Disability and Health model. Measurements will be performed prior to randomization (T0), after completion of the intervention (T1) and at follow-up (T2). The primary outcome measures are cardiorespiratory fitness, muscle strength and fatigue. Secondary outcome measures include health-related quality of life and psychosocial functioning. Furthermore, cost-effectiveness and cost-utility analyses are performed from a societal perspective. Conclusion: We hypothesize that exercise is more effective at improving physical fitness and thereby reducing fatigue and more cost-effective compared with usual care or a waiting list control group. If so, the programmes will be implemented in the Dutch clinical practice. [ABSTRACT FROM AUTHOR]

Abstract: Background: Patient care guidelines are usually implemented one at a time, yet patients are at risk for multiple, often preventable, adverse events simultaneously. Objective: This study aimed to test the effect of the SAFE or SORRY? programme on the incidence of three adverse events (pressure ulcers, urinary tract infections and falls). This paper describes Part I of the study: the effect on the incidence of adverse events. Design: A cluster randomised trial was conducted between September 2006 and November 2008. After a three-month baseline period the intervention was implemented followed by a nine-month follow-up period. Settings: Ten wards from four hospitals and ten wards from six nursing homes were stratified for institute and ward type and then randomised to intervention or usual care group. Participants: During baseline and follow-up, patients (≥18 years) with an expected length of stay of at least five days, were asked to participate. Methods: The SAFE or SORRY? programme consisted of the essential recommendations of guidelines for the three adverse events. A multifaceted implementation strategy was used for the implementation: education, patient involvement and feedback on process and outcome indicators. The usual care group continued care as usual. Data were collected on the incidence of adverse events and a Poisson regression model was used to estimate the rate ratio of the adverse events between the intervention and the usual care group at follow-up. Results: At follow-up, 2201 hospital patients with 3358 patient weeks and 392 nursing home patients with 5799 patient weeks were observed. Poisson regression analyses showed a rate ratio for the development of an adverse event in favour of the intervention group of 0.57 (95% CI: 0.34–0.95) and 0.67 (95% CI: 0.48–0.99) for hospital patients and nursing home patients respectively. Conclusion: This study showed that implementing multiple guidelines simultaneously is possible, which is promising. Patients in the intervention groups developed 43% and 33% fewer adverse events compared to the usual care groups in hospitals and nursing homes respectively. Even so, more research is necessary to underline these results. Trial registration: clinicaltrials.gov, number NCT00365430. [Copyright &y& Elsevier]

In this paper, the authors compare subgroup analyses as outlined in grant applications and their related publications. Grants awarded by the Netherlands Organization for Health Research and Development (ZonMw) from 2001 onward that were finalized before March 1, 2010, were studied. Of the 79 grant proposals, 50 (63%) were intervention studies, 18 (23%) were diagnostic studies, and 6 (8%) were prognostic studies. Subgroups were mentioned in 49 (62%) grant applications and in 53 (67%) publications. In 20 of the 79 projects (25%), the publications were completely in agreement with the grant proposal; that is, subgroups that were prespecified in the grant proposal were reported and no new subgroup analyses were introduced in the publications. Of the 149 prespecified subgroups, 46 (31%) were reported in the final report or scientific publications, and 143 of the 189 (76%) reported subgroups were based on post-hoc findings. For 77% of the subgroup analyses in the publications, there was no mention of whether these were prespecified or post hoc. Justification for subgroup analysis and methods to study subgroups were rarely reported. The authors conclude that there is a large discrepancy between grant applications and final publications regarding subgroup analyses. Both nonreporting prespecified subgroup analyses and reporting post-hoc subgroup analyses are common. More guidance is clearly needed. [ABSTRACT FROM PUBLISHER]

Background: Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods: The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion: Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration: Netherlands Trial Register (NTR): NTR2212 [ABSTRACT FROM AUTHOR]

Please cite this paper as: Vijgen S, Koopmans C, Opmeer B, Groen H, Bijlenga D, Aarnoudse J, Bekedam D, van den Berg P, de Boer K, Burggraaff J, Bloemenkamp K, Drogtrop A, Franx A, de Groot C, Huisjes A, Kwee A, van Loon A, Lub A, Papatsonis D, van der Post J, Roumen F, Scheepers H, Stigter R, Willekes C, Mol B, Van Pampus M for the HYPITAT study group. An economic analysis of induction of labour and expectant monitoring in women with gestational hypertension or pre-eclampsia at term (HYPITAT trial). BJOG 2010;117:1577-1585. To assess the economic consequences of labour induction compared with expectant monitoring in women with gestational hypertension or pre-eclampsia at term. An economic analysis alongside the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT). Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands. Women diagnosed with gestational hypertension or pre-eclampsia between 36 and 41 weeks of gestation, randomly allocated to either induction of labour or expectant monitoring. A trial-based cost-effectiveness analysis was performed from a societal perspective during a 1-year time horizon. One-year costs were estimated and health outcomes were expressed as the prevalence of poor maternal outcome defined as either maternal complications or progression to severe disease. The average costs of induction of labour ( n = 377) were €7077 versus €7908 for expectant monitoring ( n = 379), with an average difference of −€831 (95% CI −€1561 to −€144). This 11% difference predominantly originated from the antepartum period: per woman costs were €1259 for induction versus €2700 for expectant monitoring. During delivery, more costs were generated following induction (€2190) compared with expectant monitoring (€1210). No substantial differences were found in the postpartum, follow-up and for non-medical costs. In women with gestational hypertension or mild pre-eclampsia at term, induction of labour is less costly than expectant monitoring because of differences in resource use in the antepartum period. As the trial already demonstrated that induction of labour results in less progression to severe disease without resulting in a higher caesarean section rate, both clinical and economic consequences are in favour of induction of labour in these women. The trial has been registered in the clinical trial register as ISRCTN08132825. [ABSTRACT FROM AUTHOR]

Please cite this paper as: Castle P, Bulten J, Confortini M, Klinkhamer P, Pellegrini A, Siebers A, Ronco G, Arbyn M. Age-specific patterns of unsatisfactory results for conventional Pap smears and liquid-based cytology: data from two randomised clinical trials. BJOG 2010;117:1067–1073. Objective To investigate the rate of unsatisfactory cervical cell samples in liquid-based cytology (LBC) versus conventional cytology (CC) by age. Design Randomised clinical trials. Setting Population-based cervical cancer screening in the Netherlands and Italy. Population Asymptomatic women invited for screening enrolled in two randomised trials: Netherlands ThinPrep® versus conventional cytology (NETHCON; 39 010 CC, 46 064 LBC) and New Technologies in Cervical Cancer Screening (NTCC; 22 771 CC, 22 403 LBC). Methods Comparison of categorical variables using Pearson’s chi-square test, logistic regression and trend tests. Main outcome measures Proportion of unsatisfactory samples, ratio of LBC versus CC, and variation by 5-year group. Results In NETHCON, a lower percentage of LBC samples were judged to be unsatisfactory compared with CC samples (0.33 versus 1.11%). There was no significant trend in unsatisfactory results by age group for conventional cytology ( Ptrend = 0.54), but there was a trend towards an increasing percentage of unsatisfactory results with increasing age for LBC ( Ptrend < 0.001). In NTCC, a lower percentage of LBC samples were judged to be unsatisfactory compared with conventional cytology (2.59 versus 4.10%). There was a decrease in the unsatisfactory results by age group with conventional cytology ( Ptrend < 0.001) and with LBC ( Ptrend = 0.01), although the latter trend arose from the 55–60-years age group ( Ptrend = 0.62 when excluding this group). Conclusions The clinical trial in which the results were collected and the cytologic method used were the most important determinants of unsatisfactory cytology. In all situations, the proportion of unsatisfactory samples was lower in LBC compared with CC. The effects of age depended on the criteria used to define unsatisfactory results. [ABSTRACT FROM AUTHOR]

Background: Chronic hepatitis B virus infection (HBV) is an important health problem in the Turkish community in the Netherlands, and promotion of screening for HBV in this risk group is necessary. An individually tailored intervention and a culturally tailored intervention have been developed to promote screening in first generation 16-40 year old Turkish immigrants. This paper describes the design of the randomized controlled trial, which will be used to evaluate the effectiveness of the two tailored internet interventions as compared to generic online information on HBV, and to assess the added value of tailoring on socio-cultural factors.Methods/design: A cluster randomized controlled trial design, in which we invite all Rotterdam registered inhabitants born in Turkey, aged 16-40 (n = 10,000), to visit the intervention website is used. A cluster includes all persons living at one house address. The clusters are randomly assigned to either group A, B or C. On the website, persons eligible for testing will be selected through a series of exclusion questions and will then continue in the randomly assigned intervention group. Group A will receive generic information on HBV. Group B will receive individually tailored information related to social-cognitive determinants of screening. Group C will receive culturally tailored information which, next to social-cognitive factors, addresses cultural factors related to screening. Subsequently, participants may obtain a laboratory form, with which they can be tested free of charge at local health centres. The main outcome of the study is the percentage of eligible persons tested for HBV through to participation in one of the three groups. Measurements of the outcome behaviour and its determinants will be at baseline and five weeks post-intervention.Discussion: This trial will provide information on the effectiveness of a culturally tailored internet intervention promoting HBV-screening in first generation Turkish immigrants in the Netherlands, aged 16-40. The results will contribute to the evidence base for culturally tailored (internet) interventions in ethnic minority populations. An effective intervention will lead to a reduction of the morbidity and mortality due to HBV in this population. This may not only benefit patients, but also help reduce health inequalities in western countries.Trial Registration: The Netherlands National Trial Register NTR 2394. [ABSTRACT FROM AUTHOR]

Background: Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design: This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). Discussion: This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration: ClinicalTrials.gov Identifier: NCT00713843 [ABSTRACT FROM AUTHOR]

This paper's objective is to develop a method to estimate the total mortality among problem drug users. The total mortality is given by a base rate of mortality not related to drugs and the deaths that are directly and indirectly related to drugs. A fatal poisoning by drugs (overdose) is directly related to drugs, whereas a casualty due to a drug-related disease or a drug-related accident is indirectly related to drugs. As an example of a method to estimate the total mortality, the results from a cohort study among methadone patients in Amsterdam were projected on the whole population of problem drug users in The Netherlands. Due to differences between the problem drug users in Amsterdam and the rest of the country, adjustments were required. It was found that an initial estimation did not require adjustment for injection behavior and gender but did require adjustment for age and the percentage of HIV infection. In a first unadjusted estimation, the total number of deaths among problem drug users in The Netherlands in 2001 was estimated at 606 deaths. After adjustment for age, the estimated mortality decreased to 573 deaths, and after adjustment for HIV infection, this estimation again decreased to 479 deaths. From the ultimately estimated mortality, 11% was considered to be not related to drugs, 23% was attributed directly to drugs, and 66% was attributed indirectly to drugs. The number of direct deaths, as estimated by this method, falls in the same order of magnitude as the number extracted from the Causes of Death Statistics, when selecting cases according to the Drug-Related Deaths Standard as established by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Further cross-validation with other measures will be needed to assess the accuracy of the method, the limitations of which are discussed with respect to stipulating directions for future research. [ABSTRACT FROM AUTHOR]

Background: Lack of physical activity is an important risk factor for overweight, diabetes, cardiovascular disease and other chronic conditions. In the Netherlands, ethnic minority groups are generally less physically active and rate their own health poorer compared to ethnic Dutch. This applies in particular to women. For this reason women from ethnic minority groups are an important target group for interventions to promote physical activity. In the Netherlands, an exercise referral program ("Exercise on Prescription") seems successful in reaching women from ethnic minority groups, in particular because of referral by the general practitioner and because the program fits well with the needs of these women. However, the effect of the intervention on the level of physical activity and related health outcomes has not been formally evaluated within this population. This paper describes the study design for the evaluation of the effect of "Exercise on Prescription" on level of physical activity and related health outcomes. Methods: The randomized controlled trial will include 360 inactive women from ethnic minority groups, with the majority having a non-Western background, aged between 18 and 65 years old, with regular visits to their general practitioner. Participants will be recruited at healthcare centres within a deprived neighbourhood in the city of The Hague, the Netherlands. An intervention group of 180 women will participate in an exercise program with weekly exercise sessions during 20 weeks. The control group (n = 180) will be offered care as usual. Measurements will take place at baseline, and after 6 and 12 months. Main outcome measure is minutes of self reported physical activity per week. Secondary outcomes are the mediating motivational factors regarding physical activity, subjective and objective health outcomes (including wellbeing, perceived health, fitness and body size) and use of (primary) health care. Attendance and attrition during the program will be determined. Conclusion: This trial will provide information on the effectiveness of an exercise referral scheme on the short and long term among women from ethnic minority groups, mainly non-Western, in the Netherlands. The results of this study will contribute to the evidence base for interventions in ethnic minority populations. Trial registration: Dutch Trial register: NTR1294 [ABSTRACT FROM AUTHOR]

Background: In the Netherlands, the first adolescents with diabetes mellitus type 2 as a result of obesity have recently been diagnosed. Therefore, it is very important that programs aiming at the prevention of type 2 diabetes of obese adolescents are developed and evaluated. Methods: Go4it is a multidisciplinary group treatment that focuses on: 1) increasing awareness of the current dietary and physical activity behaviour (i.e. energy balance behaviour), 2) improving diet, 3) decreasing sedentary behaviour, 4) increasing levels of physical activity, and 5) coping with difficult situations. Go4it consists of 7 sessions with an interval of 2-3 weeks. The effectiveness of the multidisciplinary group treatment compared with usual care (i.e. referral to a dietician) was evaluated in a randomised controlled trial. We examined effects on BMI(sds), body composition, energy expenditure, glucose tolerance and insulin resistance (primary outcome measure), as well as dietary and physical activity behaviour and quality of life. An economic evaluation from a societal perspective was conducted alongside the randomised trial to evaluate the cost-effectiveness of the multidisciplinary treatment program vs. usual care. Discussion: In this paper we described a multidisciplinary treatment program (Go4it) for obese adolescents and the design of a randomised controlled trial and economic evaluation to evaluate its effectiveness and cost-effectiveness. Trial registration: Netherlands Trial Register (ISRCTN27626398). [ABSTRACT FROM AUTHOR]

Shortening the turnaround time of microbiological procedures was associated with an improved clinical outcome in two studies performed in the USA. To study the clinical impact of a shortened turnaround time in a northwest European setting in which an automated system was used for bacterial identification and susceptibility testing, a single-blind, prospective, randomised controlled trial was conducted in a hospital in the Netherlands. All hospitalised patients with a bacterial infection confirmed by culture were randomly assigned to a control (conventional) group or an intervention (rapid) group. Overnight methods were used for identification and susceptibility testing in the control group, while the Vitek 2 system (bioMérieux, Marcy l’Etoile, France) was used in the rapid group. In each of three consecutive study periods, accelerating factors were added progressively to the laboratory workflow of the rapid group to increase same-day reporting, whereas methods remained identical in the conventional group. The turnaround time of the microbiological cycle using the Vitek 2 system as compared to conventional methods was studied and the clinical impact of a shortened turnaround time assessed in terms of mortality, morbidity, and cost. For the rapid groups, the turnaround time was significantly shorter for oral reporting of final susceptibility results in all three study periods and for reporting on paper in the third study period. There was no significant difference between groups in any of the clinical impact variables. Vitek 2 results were available for reporting significantly earlier as compared to conventional testing. For the overall patient group in our hospital setting, however, this had no clinical impact. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the use of an automated test ordering and feedback system (named GRIF) in daily practice. The system produces recommendations to general practitioners (GPs) to improve the application of accepted practice guidelines for test ordering.Methods: A randomised controlled trial with balanced block design was carried out in general practices in two regions of the Netherlands from August 2000 to July 2001. We implemented the GRIF system on the workstations at the offices of the participating GPs. The GPs (n = 11) were asked to use GRIF during patient consultation instead of filling in the paper request form. The system displayed critical comments about their non-adherence to the guidelines as apparent from the request forms.Results: The median time of producing the comments plus the response time of the GP was 13 s. Of the 2780 presented recommendations, 4.3% were accepted. Advice of the GRIF system that presents a concrete test to request in a particular situation is adhered to most frequently. Finally, there seems to be a decrease of accepted comments over the trial period.Conclusion: Computerised recommendations should contain, if possible, suggestions for alternative tests to improve the application of these recommendations. Furthermore, creative solutions must be developed to avoid that GPs get used to the recommendations of critiquing systems and to stimulate a better adherence to these recommendations. [Copyright &y& Elsevier]

A primary aim in pharmacovigilance is the timely detection of either new adverse drug reactions (ADRs) or a relevant change of the frequency of ADRs that are already known to be associated with the drugs involved, i.e. signal detection. Adequate signal detection solely based on the human intellect (case-by-case analysis or qualitative signal detection) has proven its value. However, it is becoming increasingly time consuming given the growing volume of data, as well as less effective, especially in more complex associations, such as drug-drug interactions, syndromes and when various covariates are involved. In quantitative signal detection, measures that express the extent in which combinations of drug(s) and clinical event(s) are disproportionately present in the database of reported suspected ADRs are used to reveal associations of interest. Although the rationale and the methodology of the various quantitative approaches differ, they all share the characteristic in that they express to what extent the number of observed cases differs from the number of expected cases. Recent years have shown that the use of quantitative measures in addition to qualitative analysis is a step forward in signal detection in pharmacovigilance. This paper uses historical, classic examples and studies to illustrate the principles, pros and cons of especially quantitative methods in signal detection and adds a flavour of future perspective. [ABSTRACT FROM AUTHOR]