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Objective: Fear of Cancer Recurrence (FCR) is highly prevalent among cancer survivors and leads to decreased quality of life and increased healthcare costs. We assessed the effectiveness of a guided online primary care intervention for FCR, compared to waiting list. Methods: In this RCT, participants were recruited online and randomised 1:1. All adults who finished successful curative cancer treatment between 3 months and 10 years ago, wanted support for FCR, and had sufficient Dutch skills were eligible. The intervention consisted of a 10‐week online programme and three to five video calling sessions with a trained mental health worker. After 6 months, the control group received the same intervention. The primary outcome was the difference between the groups in the change in FCR severity from baseline (T0) to 6 months (T2), measured online with the short form of the Fear of Cancer Recurrence Inventory. Results: One hundred and seventy‐three participants were enroled and randomised to the intervention (n = 86) or control group (n = 87). FCR severity dropped 2.1 points more in the intervention group than in the control group (2.7 points (SD = 3.9) versus 0.6 points (SD = 3.6), t(154) = 3.4, p = 0.0007). General mental well‐being also improved significantly in the intervention group and remained stable in the control group. These improvements remained at 10 months follow up. Conclusions: This easily accessible and relatively inexpensive intervention effectively reduces FCR and has potential to replace or precede existing more intensive psychological treatments, improving patients' access to care. Trial registration: The trial was prospectively registered in the Netherlands Trial Register on 25‐02‐2019 with number NL7573. [ABSTRACT FROM AUTHOR]

Objective: Improving shared decision‐making (SDM) enables more tailored cancer treatment decisions. We evaluated a Time Out consultation (TOC) with the general practitioner (GP), between cancer diagnosis and treatment decision, which aims at supporting SDM and improving continuity of primary care. This study aims to evaluate the effects of a TOC on perceived SDM, information provision and self‐efficacy. Methods: This randomised controlled trial included newly diagnosed patients with curable cancer (breast, lung, colorectal, gynaecologic and melanoma) from four Dutch hospitals. Primary outcome is perceived SDM and secondary outcomes are information provision and self‐efficacy. Results: One hundred fifty‐four patients (control n = 77, intervention n = 77) – female: 75%, mean age: 61 (SD ± 11.9). In the intervention group, 80.5% (n = 62) had a TOC, of which 82.3% (n = 51) took place after treatment decision. Perceived SDM was lower in the intervention group (−8.9 [95% CI: 0.6–17.1]). Among those with a TOC before treatment decision (n = 11), perceived SDM was comparable to the control group (66.5 ± 27.2 vs. 67.9 ± 26.1). Conclusion: Even though patients are motivated to have a TOC, implementing a TOC between diagnosis and treatment decision is challenging. Effects of a timely TOC could not be established. Non‐timely TOC decreased perceived SDM. Planning of the TOC should be optimised, and future research should establish if adequately timed TOC results in improved SDM in cancer patients. [ABSTRACT FROM AUTHOR]

Background: Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care.Methods: A randomized controlled trial in a primary care setting in which 1934 participants aged 45-70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (- 2.26 mmHg; 95% CI - 4.01: - 0.51) and total cholesterol (- 0.15 mmol/l; 95% CI - 0.23: - 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective.Results: After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (- 0.0154; 95% CI - 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention.Conclusions: Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended.Trial Registration: Dutch Trial Register NTR4277 , registered on 26 November 2013. [ABSTRACT FROM AUTHOR]

Background: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention.Methods/design: A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction.Discussion: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice.Trial Registration: ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016. [ABSTRACT FROM AUTHOR]

Background: Earlier studies have shown that clinical queries are common among doctors. Data on the information-seeking behaviour of general practice (GP) trainees are scarce though, and numbers studied are small.Objective: The objective of this study was to determine how often and how GP trainees search for answers to clinical queries encountered in daily clinical practice.Methods: Third-year GP trainees kept logs on all patient contacts for eight consecutive practice days. Information was obtained on patient contacts (description), clinical queries (frequency, type), seeking behaviour (frequency, moment, reason not to search, resources used, duration of search) and answers (frequency, impact). Descriptive analyses were performed; frequencies and percentages were computed. We calculated the number of clinical queries per patient, the number of searches per query and the number of answers per search.Results: Seventy-six trainees reported 1533 clinical queries about 7300 patients presenting 7619 complaints [mean of 0.2 queries per patient, standard deviation (SD) 0.1]. For most of the queries trainees pursued an answer (mean of 0.8 per query, SD 0.2), mostly during consultation (61% of searches), and frequently retrieved answers (mean of 0.8 per search, SD 0.17) they reported to improve clinical decision making in 26%. Most common resources were colleagues or supervisors (28%), and national GP guidelines (26%). The median duration of a search was 4 minutes (interquartile range 3).Conclusion: GP trainees have one clinical query per five patients. They often attempted to find answers and reported to succeed in most of the searches, primarily by consulting supervisors or colleagues and national GP guidelines. [ABSTRACT FROM AUTHOR]

Background The increasing prevalence of cardiometabolic disease (CMD) in combination with an ageing population is a major public health problem. Early detection and management of individuals at risk for CMD is required to prevent future health problems with associated costs. General practice is the optimal health care setting to accomplish this goal. Prevention programs for identification and treatment of patients with an increased risk for CMD in primary care have been proven feasible. However, the effectiveness and cost-effectiveness have yet to be demonstrated. The 'Personalized Prevention Approach for CardioMetabolic Risk' (PPA CMR) is such a prevention program. The objective of the INTEGRATE study is to investigate the effectiveness and cost-effectiveness of PPA CMR, as well as to establish determinants for participation and compliance. Methods The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group. In approximately 40 general practices, all enlisted patients without CMD aged 45-70 years, are invited to participate in PPA CMR. After an online risk estimation, patients with a score above risk threshold are invited to the GP for additional measurements, detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling. At baseline and after twelve months of follow-up lifestyle, health and work status of all participants are established with online questionnaires. Additionally after twelve months, we will determine health care utilization, costs of PPA CMR and compliance. Primary endpoints are the number of newly detected patients with CMD and changes in individual risk factors between the intervention and waiting list control group. Medical data will be extracted from the GPs' electronic medical records. In order to assess factors related to participation, we will send questionnaires to non-participants and assess characteristics of participating practices. For all participants, additional demographic characteristics will be available through Statistics Netherlands. Discussion The INTEGRATE study will provide insight into the effectiveness and cost-effectiveness of PPA CMR as well as determinants for participation and compliance, which represents essential information to guide further large-scale implementation of primary prevention programs for CMD. Trial registration number NTR4277, The Netherlands National Trial Register, 26-11-2013. [ABSTRACT FROM AUTHOR]

Purpose. Although in the last decades primary care research has evolved with great success, there is a growing need to prioritize the topics given the limited resources available. Therefore, we constructed a nationwide database of ongoing primary care research projects in the Netherlands, and we assessed if the distribution of research topics matched with primary care practice. Methods. We conducted a survey among the main primary care research centres in the Netherlands and gathered details of all ongoing primary care research projects. We classified the projects according to research topic, relation to professional guidelines and knowledge deficits, collaborative partners and funding source. Subsequently, we compared the frequency distribution of clinical topics of research projects to the prevalence of problems in primary care practice. Results. We identified 296 ongoing primary care research projects from 11 research centres. Most projects were designed as randomized controlled trial (35%) or observational cohort (34%), and government funded mostly (60%). Thematically, most research projects addressed chronic diseases, mainly cardiovascular risk management (8%), depressive disorders (8%) and diabetes mellitus (7%). One-fifth of the projects was related to defined knowledge deficits in primary care guidelines. From a clinical primary care perspective, research projects on dermatological problems were significantly underrepresented (P = 0.01). Conclusions. This survey of ongoing projects demonstrates that primary care research has a firm basis in the Netherlands, with a strong focus on chronic disease. The fit with primary care practice can improve, and future research should address knowledge deficits in professional guidelines more. [ABSTRACT FROM PUBLISHER]

Background: Prevention programs for cardiometabolic diseases (CMD), including cardiovascular disease, diabetes mellitus and chronic kidney disease are feasible, but evidence for the cost-effectiveness of selective CMD prevention programs is lacking. Response rates have an important role in effectiveness, but methods to increase response rates have received insufficient attention. The aim of the current study is to determine the feasibility and the success rate of a variety of response enhancing strategies to increase the participation in a selective prevention program for CMD. Methods: The INTEGRATE study is a Dutch randomised controlled trial to assess the effectiveness and cost-effectiveness of a stepwise program for CMD prevention. During the INTEGRATE study we developed ten different response enhancing strategies targeted at different stages of non-response and different patient populations and evaluated these in 29 general practices. Results: A face-to-face reminder by the GP increased the response significantly. Digital reminders targeted at patients with an increased CMD risk showed a positive trend towards participation. Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination. Translated materials, information gatherings at the practice, self-management toolkits, reminders by telephone, information letters, local media attention and SMS text reminders did not increase the response to our program. Conclusions: Inviting or reminding patients by e-mail or during GPs consultation may enhance response rates in a selective prevention program for CMD. Different response-enhancing strategies have different patient target populations and implementation issues, therefore practice characteristics need to be taken into account when implementing such strategies. Trial registration: Dutch trial Register number NTR4277. Registered 26 November 2013. [ABSTRACT FROM AUTHOR]

Background: Although the recovery of patients suffering from low back pain is highly context dependent, patient preferences about treatment options are seldom incorporated into the therapeutic plan. Shared decision-making (SDM) offers a tool to overcome this deficiency. The reinforcement by the general practitioner (GP) of a 'shared' chosen therapy might increase patients' expectations of favourable outcomes and thus contribute to recovery. Methods: In the Netherlands, a clustered randomised controlled trial was performed to assess the effectiveness of shared decision-making followed by positive reinforcement of the chosen therapy (SDM&PR) on patient-related clinical outcomes. Overall, 68 GPs included 226 patients visiting their GP for a new episode of non-chronic low back pain. GPs in the intervention group were trained in implementing SDM&PR using a structured training programme with a focus on patient preferences in reaching treatment decisions. GPs in the control group provided care as usual. The primary outcome was the change in physical disability measured with the Roland-Morris disability questionnaire (RMD) during the six-month follow-up after the first consultation. Physical disability (RMD), pain, adequate relief, absenteeism and healthcare consumption at 2, 6, 12 and 26 weeks were secondary outcomes. A multivariate analysis with a mixed model was used to estimate the differences in outcomes. Results: Of the patients in the intervention and the control groups, 66 and 62%, respectively, completed the follow-up. Most patients (77%) recovered to no functional restrictions due to back pain within 26 weeks. No significant differences in the mean scores for any outcome were observed between intervention patients and controls during the follow-up, and in multivariate analysis, there was no significant difference in the main outcome during the six-month follow-up. Patients in the intervention group reported more involvement in decision-making. Conclusion: This study did not detect any improvement in clinical outcome or in health care consumption of patients with non-chronic low back pain after the training of GPs in SDM&PR. The implementation of SDM merely introduces task-oriented communication. The training of the GPs may have been more effective if it had focused more on patient-oriented communication techniques and on stressing the expectation of favourable outcomes. Trial registration: The Netherlands National Trial Register (NTR) number: NTR1960. The trial was registered in the NTR on August 20, 2009. [ABSTRACT FROM AUTHOR]

This is a 4 week, randomized, double-blind, placebo-controlled study to examine the effects of methylphenidate as add-on therapy to mirtazapine compared to placebo for treatment of depression in terminally ill cancer patients. It involved 88 terminally ill cancer patients from University of Malaya Medical Centre, Kuala Lumpur, Malaysia. They were randomized and treated with either methylphenidate or placebo as add on to mirtazapine. The change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 3 was analyzed by linear regression. Changes of MADRS and Clinical Global Impression-Severity Scale (CGI-S) over 28 days were analyzed using mixed model repeated measures (MMRM). Secondary analysis of MADRS response rates, defined as 50% or more reduction from baseline score. A significantly larger reduction of Montgomery-Åsberg Depression Rating Scale (MADRS) score in the methylphenidate group was observed from day 3 (B=4.14; 95% CI=1.83–6.45). Response rate (defined as 50% or more reduction from baseline MADRS score) in the methylphenidate treated group was superior from day 14. Improvement in Clinical Global Impression-Severity Scale (CGI-S) was greater in the methylphenidate treated group from day 3 until day 28. The drop-out rates were 52.3% in the methylphenidate group and 59.1% in the placebo group (relative risk=0.86, 95%CI=0.54–1.37) due to cancer progression. Nervous system adverse events were more common in methylphenidate treated subjects (20.5% vs 9.1%, p=0.13). In conclusions, methylphenidate as add on therapy to mirtazapine demonstrated an earlier antidepressant response in terminally ill cancer patients, although at an increased risk of the nervous system side effects. [ABSTRACT FROM AUTHOR]

Effective preventive strategies for cardiometabolic disease (CMD) are needed. We aim to establish the effectiveness of a stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. We conducted a RCT between 2014 and 2017. Individuals (45-70 years) without CMD or CMD risk factors were invited for stepwise CMD risk assessment through a risk score (step1), additional risk assessment at the practice in case of high-risk (step2) and individualized follow-up treatment if indicated (step3). We compared newly detected CMD and newly prescribed drugs during one-year follow-up, and change in CMD risk profile between baseline and one-year follow-up among participants who completed step2 to matched controls. A CMD was diagnosed almost three times more often (OR 2.90, 95% CI 2.25: 3.72) in the intervention compared to the control group, in parallel with newly prescribed antihypertensive and lipid lowering drugs (OR 2.85, 95% CI 1.96: 4.15 and 3.23, 95% CI 2.03: 5.14 respectively). Waist circumference significantly decreased between the intervention compared to the control group (mean -3.08 cm, 95% CI -3.73: -2.43). No differences were observed for changes in BMI and smoking. Systolic blood pressure (mean -2.26 mmHg, 95% CI -4.01: -0.51) and cholesterol ratio (mean -0.11, 95% CI -0.19: -0.02) significantly decreased within intervention participants between baseline and one-year follow-up. In conclusion, implementation of the CMD prevention program resulted in the detection of two- to threefold more patients with CMD. A significant drop in systolic blood pressure and cholesterol levels was found after one year of treatment. Modelling of these results should confirm the effect on long term endpoints. Trial registration: Dutch trial Register number NTR4277. [ABSTRACT FROM AUTHOR]

Background A proactive integrated approach has shown to preserve daily functioning among older people in the community. The aim is to determine the cost-effectiveness of a proactive integrated primary care program. Methods Economic evaluation embedded in a single-blind, 3-armed, cluster-randomized controlled trial with 12 months’ follow-up in 39 general practices in the Netherlands. General practices were randomized to one of 3 trial arms: (1) an electronic frailty screening instrument using routine medical record data followed by standard general practitioner (GP) care; (2) this screening instrument followed by a nurse-led care program; or (3) usual care. Health resource utilization data were collected using electronic medical records and questionnaires. Associated costs were calculated. A cost-effectiveness analysis from a societal perspective was undertaken. The incremental cost per quality-adjusted life-year was calculated comparing proactive screening arm with usual care, and screening plus nurse-led care arm with usual care, as well as the screening arm with screening plus nurse-led care arm. Results Out of 7638 potential participants, 3092 (40.5%) older adults participated. Whereas effect differences were minor, the total costs per patient were lower in both intervention groups compared with usual care. The probability of cost-effectiveness at €20,000 per QALY threshold was 87% and 91% for screening plus GP care versus usual care and for screening plus nurse-led care compared to usual care, respectively. For screening plus nurse-led care vs screening plus standard GP care, the probability was 55%. Conclusion A proactive screening intervention has a high probability of being cost-effective compared to usual care. The combined intervention showed less value for money. [ABSTRACT FROM AUTHOR]