Background:Tobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment.Objective:The primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates.Methods:This study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide–validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation.Results:None of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive.Conclusions:In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions.Trial Registration:Netherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150
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Fully aware of the unusual timing of submitting a commentary 30 years later, we want to reflect on the June edition of the British Journal of Clinical Pharmacology (BJCP) (1993), which featured four research articles on education in clinical pharmacology and therapeutics (CPT) written by our former professor, Theo de Vries, and an editorial highlighting the imperative to improve CPT education, specifically by paying more attention to rational drug prescribing for common diseases.1–5 This plea was illustrated by five cartoons (Figure 1) and formed the basis for the World Health Organization's (WHO) Guide to Good Prescribing and its 6-step. The first four cartoons portrayed the suboptimal state of CPT education as a metaphorical ‘Clinical Pharmacology Continent’ (CPC) and a ‘General Practitioners Island’ (GPI), with a large gap between them. While clinical pharmacologists investigated new drug therapies, general practitioners frequently found themselves unprepared when making rational treatment decisions.1 The final cartoon introduced a solution: problembased learning education, depicted as a bridge connecting the continent and the island. Over the past 30 years, considerable progress has been achieved in bridging the gap. Therefore, we intend to illustrate this transformation with a similar cartoon (Figure 2).
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Objective: To evaluate the delivery, acceptance and experiences regarding a traditional and teletreatment approach to mirror therapy as delivered in a randomized controlled trial. Design: Mixed methods, prospective study. Setting: Rehabilitation centres, hospital and private practices. Subjects: Adult patients with phantom pain following lower limb amputation and their treating physical and occupational therapists. Interventions: All patients received 4 weeks of traditional mirror therapy (n=51), followed by 6 weeks of teletreatment (n=26) or 6 weeks of self-delivered mirror therapy (n=25). Main measures: Patient files, therapist logs, log files teletreatment, acceptance questionnaire and interviews with patients and their therapists. Results: In all, 51 patients and 10 therapists participated in the process evaluation. Only 16 patients (31%) received traditional mirror therapy according to the clinical framework during the first 4 weeks. Between weeks 5 and 10, the teletreatment was used by 14 patients (56%) with sufficient dose. Teletreatment usage decreased from a median number of 31 (weeks 5–10) to 19 sessions (weeks 11–24). Satisfactory teletreatment user acceptance rates were found with patients demonstrating higher scores (e.g. regarding the usefulness to control pain) than therapists. Potential barriers for implementation of the teletreatment perceived by patients and therapists were related to insufficient training and support as well as the frequency of technical problems. Conclusion: Traditional mirror therapy and the teletreatment were not delivered as intended in the majority of patients. Implementation of the teletreatment in daily routines was challenging, and more research is needed to evaluate user characteristics that influence adherence and how technology features can be optimized to develop tailored implementation strategies.
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Background: Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically. Objective: The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting. Methods: The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients’ adherence, acceptability, and credibility will be examined. Results: The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020. Conclusions: The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment.
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OBJECTIVES: To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. DESIGN: Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. SETTING: Primary care setting, 39 general practices in the Netherlands. PARTICIPANTS: Community-dwelling people aged 60 and older (N = 3,092). INTERVENTIONS: A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. MEASUREMENTS: Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0–15)); higher scores indicat greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. RESULTS: The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77–1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80–1.96; control group, 2.03, 95% CI = 1.9 –2.13; P = .03). No differences in quality of life were observed. CONCLUSION: Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more robust results.
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Biotherapeutic medicines such as peptides, recombinant proteins, and monoclonal antibodies have successfully entered the market for treating or providing protection against chronic and life-threatening diseases. The number of relevant commercial products is rapidly increasing. Due to degradation in the gastro-intestinal tract, protein-based drugs cannot be taken orally but need to be administered via alternative routes. The parenteral injection is still the most widely applied administration route but therapy compliance of injection-based pharmacotherapies is a concern. Long-acting injectable (LAI) sustained release dosage forms such as microparticles allow less frequent injection to maintain plasma levels within their therapeutic window. Spider Silk Protein and Poly Lactic-co-Glycolic Acid (PLGA) have been attractive candidates to fabricate devices for drug delivery applications. However, conventional microencapsulation processes to manufacture microparticles encounter drawbacks such as protein activity loss, unacceptable residual organic solvents, complex processing, and difficult scale-up. Supercritical fluids (SCF), such as supercritical carbon dioxide (scCO2), have been used to produce protein-loaded microparticles and is advantageous over conventional methods regarding adjustable fluid properties, mild operating conditions, interfacial tensionless, cheap, non-toxicity, easy downstream processing and environment-friendly. Supercritical microfluidics (SCMF) depict the idea to combine strengths of process scale reduction with unique properties of SCF. Concerning the development of long-acting microparticles for biological therapeutics, SCMF processing offers several benefits over conventionally larger-scale systems such as enhanced control on fluid flow and other critical processing parameters such as pressure and temperature, easy modulation of product properties (such as particle size, morphology, and composition), cheaper equipment build-up, and convenient parallelization for high-throughput production. The objective of this project is to develop a mild microfluidic scCO2 based process for the production of long-acting injectable protein-loaded microparticles with, for example, Spider Silk Protein or PLGA as the encapsulating materials, and to evaluate the techno-economic potential of such SCMF technology for practical & industrial production.
Background: This follow-up study investigated the year-round effects of a four-week randomized controlled trial using different types of feedback on employees’ physical activity, including a need-supportive coach intervention. Methods: Participants (n=227) were randomly assigned to a Minimal Intervention Group (MIG; no feedback), a Pedometer Group (PG; feedback on daily steps only), a Display Group (DG; feedback on daily steps, on daily moderateto-vigorous physical activity [MVPA] and on total energy expenditure [EE]), or a Coaching Group (CoachG; same as DG with need supportive coaching). Daily physical activity level (PAL; Metabolic Equivalent of Task [MET]), number of daily steps, daily minutes of moderate to vigorous physical activity (MVPA), active daily EE (EE>3 METs) and total daily EE were measured at five time points: before the start of the 4-week intervention, one week after the intervention, and 3, 6, and 12 months after the intervention. Results: For minutes of MVPA, MIG showed higher mean change scores compared with the DG. For steps and daily minutes of MVPA, significantly lower mean change scores emerged for MIG compared with the PG. Participants of the CoachG showed significantly higher change scores in PAL, steps, minutes of MVPA, active EE, total EE compared with the MIG. As hypothesized, participants of the CoachG had significantly higher mean change scores in PAL and total EE compared with groups that only received feedback. However, no significant differences were found for steps, minutes of MVPA and active EE between CoachG and PG. Conclusions: Receiving additional need-supportive coaching resulted in a higher PAL and active EE compared with measurement (display) feedback only. These findings suggest to combine feedback on physical activity with personal coaching in order to facilitate long-term behavioral change. When it comes to increasing steps, minutes of MVPA or active EE, a pedometer constitutes a sufficient tool. Trial registration: Clinical Trails.gov NCT01432327. Date registered: 12 September 2011
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Previous research shows that automatic tendency to approach alcohol plays a causal role in problematic alcohol use and can be retrained by Approach Bias Modification (ApBM). ApBM has been shown to be effective for patients diagnosed with alcohol use disorder (AUD) in inpatient treatment. This study aimed to investigate the effectiveness of adding an online ApBM to treatment as usual (TAU) in an outpatient setting compared to receiving TAU with an online placebo training. 139 AUD patients receiving face-to-face or online treatment as usual (TAU) participated in the study. The patients were randomized to an active or placebo version of 8 sessions of online ApBM over a 5-week period. The weekly consumed standard units of alcohol (primary outcome) was measured at pre-and post-training, 3 and 6 months follow-up. Approach tendency was measured pre-and-post ApBM training. No additional effect of ApBM was found on alcohol intake, nor other outcomes such as craving, depression, anxiety, or stress. A significant reduction of the alcohol approach bias was found. This research showed that approach bias retraining in AUD patients in an outpatient treatment setting reduces the tendency to approach alcohol, but this training effect does not translate into a significant difference in alcohol reduction between groups. Explanations for the lack of effects of ApBM on alcohol consumption are treatment goal and severity of AUD. Future ApBM research should target outpatients with an abstinence goal and offer alternative, more user-friendly modes of delivering ApBM training.
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Review in het kader van COST Action IS1106 Working group 3 In the review below, we summarize resent empirical research about practising offender supervision in The Netherlands on six theme’s: 1. The roles, characteristics, recruitment and training of key actors in the delivery of offender supervision. 2. Interactions and relationships between key actors in the delivery of offender supervision and other relevant professionals. 3. The delivery/practice/performance of offender supervision. 4. The role of tools and technologies in the delivery of OS. 5. The management, supervision and/or regulation of practitioners and their practice. 6. Reflections / contextual issues Ongoing research is discussed in the descriptions of the different theme’s. We conclude with a short reflection about research on practising supervision in the Netherlands. The review is limited to studies about adults. Studies on community sentences have not yet been addressed, we will do this in the next version.
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Competent delivery of interventions in child and youth social care is important, due to the direct effect on client outcomes. This is acknowledged in evidence-based interventions (EBI) when, post-training, continued support is available to ensure competent delivery of the intervention. In addition to EBI, practice-based interventions (PBI) are used in the Netherlands. The current paper discusses to what extent competent delivery of PBI can be influenced by introducing supervision for professionals. This study used a mixed-method design: (1) A small-n study consisting of six participants in a non-concurrent multiple baseline design (MBL). Professionals were asked to record conversations with clients during a baseline period (without supervision) and an intervention period (with supervision). Visual inspection, the non-overlap of all pairs (NAP), and the Combinatorial Inference Technique (CIT) scores were calculated. (2) Qualitative interviews with the six participants, two supervisors, and one lead supervisor focused on the feasibility of the supervision. Four of six professionals showed improvement in treatment fidelity or one of its sub-scales. Had all participants shown progress, this could have been interpreted as an indication that targeted support of professionals contributes to increasing treatment integrity. Interviews have shown that supervision increased the professionals’ enthusiasm, self-confidence, and awareness of working with the core components of the intervention. The study has shown that supervision can be created for PBI and that this stimulates professionals to work with the core components of the intervention. The heterogeneous findings on intervention fidelity can be the result of supervision being newly introduced.
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