Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT
Algemene gegevens / General Information Programma / Programme Agiko-stipendia Subsidieronde / Subsidy round Najaarsronde 2007 Projecttitel / Project title Determinanten van het gebruik van anti-depressiva in de huisartpraktijk Aanvrager / Applicant Prof. dr. K. van der Meer MD PhD Functie / Position: | Opleiding / Education: Studierichting / Subject: T: 050-3632970 | F: | E:
[email protected]
Universitair Medisch Centrum Groningen Disciplinegroep Huisartsgeneeskunde Postbus 196 9700 AD GRONINGEN Projectleden / Project members Prof. dr. K. van der Meer MD PhD (Projectleider en penvoerder) Functie / Position: professor huisartsgeneeskunde | Opleiding / Education: Studierichting / Subject: T: 050-3632970 | F: | E:
[email protected]
Universitair Medisch Centrum Groningen Disciplinegroep Huisartsgeneeskunde Postbus 196 9700 AD GRONINGEN Nederland Prof. dr. K. van der Meer MD PhD (Bestuurlijk verantwoordelijke) Functie / Position: professor Huisartsgeneeskunde | Opleiding / Education: Studierichting / Subject: T: 050-3632970 | F: | E:
[email protected]
Universitair Medisch Centrum Groningen Disciplinegroep Huisartsgeneeskunde Postbus 196 9700 AD GRONINGEN Nederland Dr. G.H. de Bock (Projectcommissielid) Functie / Position: associate professor epidemiology | Opleiding / Education:
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 1
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT Studierichting / Subject: T: 050-3610938 | F: | E:
Universitair Medisch Centrum Groningen Epidemiologie Postbus 30001 9700 RB GRONINGEN Nederland Dr. C.L.H. Bockting (Projectcommissielid) Functie / Position: associate professor Psychology | Opleiding / Education: Studierichting / Subject: T: 050-3636479 | F: | E:
Rijksuniversiteit Groningen Faculteit der Gedrags- en Maatschappijwetenschappen Klinische Psychologie Grote Kruisstraat 2/1 9712 TS GRONINGEN Nederland Dr. H.J. Conradi (Projectcommissielid) Functie / Position: onderzoeker/psycholoog | Opleiding / Education: Studierichting / Subject: T: 050-3612065 | F: | E:
Universitair Medisch Centrum Groningen Psychiatrie Postbus 30001 9700 RB GRONINGEN Nederland Prof. dr. F.M. Haaijer-Ruskamp (Projectcommissielid) Functie / Position: professor Drug Utilization Studies | Opleiding / Education: Studierichting / Subject: T: 050-3633216 | F: | E:
Universitair Medisch Centrum Groningen Disciplinegroep Klinische Farmacologie Antonius Deusinglaan 1 9713 AV GRONINGEN Nederland Prof. dr. W. Nolen MD PhD (Projectcommissielid) Functie / Position: professor psychiatry | Opleiding / Education: Studierichting / Subject:
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 2
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT T: 050-3612079 | F: | E:
Universitair Medisch Centrum Groningen Psychiatrie Postbus 30001 9700 RB GRONINGEN Nederland Drs. E. Piek MD (Uitvoerder) Functie / Position: AGIKO | Opleiding / Education: Studierichting / Subject: T: 0546-538152 | F: | E:
Universitair Medisch Centrum Groningen Disciplinegroep Huisartsgeneeskunde Postbus 196 9700 AD GRONINGEN Nederland Samenwerking / Collaboration
Projectgegevens / Project information Datum indienen (via ProjectNet) / Date of application Aandachtsgebieden / Focus Projecttype / Project type Onderzoeksproject Samenvatting / Summary Major depression is a highly prevalent mental disorder that frequently runs a chronic, intermittent lifelong course, which makes long-term treatment increasingly important. Long-term treatment with antidepressants (AD) is the most used strategy. Meta-analyses show that depression can be treated effectively by AD in the acute treatment phase (till remission) and in the continuation treatment phase (up to 3 months after remission). However, only a few studies addressed the efficacy of AD in the maintenance treatment phase (> 3 months after remission) in general, and in primary care in particular, and the debate regarding optimal indication, duration and dose of AD maintenance therapy is still going on. Therefore, and because of the fact that the majority of depressed patients is treated by the General Practitioner (GP), it is essential to gain more insight in long-term AD usage and associated depression outcomes in primary care. In this study we want to examine the long-term use of AD in daily practice in primary care in order to contribute to the development of more evidence-based clinical guidelines and to reduce costs of under- and overprescription of AD. We will examine four subgroups of patients defined by the logical combination of two criteria: (a) is the patient according to guidelines indicated for maintenance treatment with AD or not?, and (b) is the patients’ AD use consistent with guidelines concerning maintenance treatment or not? The following issues will be examined. (1) The essential preliminary topic: How to assess reliably long-term AD usage? (2) For each of the four subgroup of patients we want to know: (a) What are numbers, sociodemographic characteristics and AD usage patterns in terms of dose and
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 3
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT duration? (b) What are determinants of (dis-)continuation of AD use? (c) How is the depression course in the four groups? (3) What are the costs related to long-term AD use? These issues will be examined in the group of depressed primary care patients of the NESDA (The Netherlands Study of Depression and Anxiety) cohort, the largest naturalistic study on depression and anxiety ever conducted in the Netherlands. This group of patients is aged between 18 to 65 and consists of 1919 primary care patients with a lifetime diagnosis of major depression, of which 1106 have a current depression. The patients will be followed up to 8 years. Trefwoorden / Keywords depressie, anti-depressiva, huisartsgeneeskunde, rationeel geneesmiddelgebruik
Inhoud / Content Probleemstelling / Problem definition Major depression is a highly prevalent mental disorder that frequently runs a chronic, intermittent lifelong course with incomplete remission from episodes, residual symptoms, and a very high and after each episode progressively increasing chance of recurrence (Simon, 2000; ESEMeD/MHEDEA 2000 consortium, 2004a). Therefore, long-term treatment has become increasingly important. One long-term treatment strategy is to continue antidepressants (AD) use during one or more years after remission has been obtained; the first 3 months in order to prevent relapse (continuation treatment), thereafter to prevent recurrence (maintenance treatment). SSRI usage has increased explosively in the Netherlands between 1992-2001 (the prevalence increased from 2.2 to 17.1 persons per 1,000 persons per year). This is due to both an increase in number of patients starting SSRIs (3.7 to 14.5 per 1,000 persons per year) and because of a longer duration (from 119 to 199 days) of usage (Meijer et al., 2004). Meta-analyses, based on systematic reviews of randomized controlled trials concerning the efficacy of AD, have found AD to be effective in both the acute treatment phase (i.e. until remission) and continuation treatment phase (i.e. up to 3 months after remission) (Viguera et al., 1998; Geddes et al., 2003; Kaymaz et al., in press). Especially, in patients with multiple prior episodes longer AD use may be protective (Dawson et al., 1998). However, several important issues remain unresolved. First, the vast majority of studies included in the above mentioned meta-analyses have follow-up periods of no more than one year, whereas from the perspective of the recurrent character of depression, studies covering the maintenance phase beyond one year up to 3 years or longer are urgently needed. Second, the mentioned meta-analyses mostly concern studies on efficacy in secondary care, whereas most depressive patients are treated in primary care (ESEMeD/MHEDEA 2000 consortium, 2004). Although a review considering evidence for the efficacy of pharmacotherapy in primary care suggests that maintenance AD treatment is indicated for a substantial number of patients, empirical evidence for its efficacy is very meager (Simon, 2002). Moreover, comparison of (inter-) national clinical guidelines concerning maintenance treatment by AD, provided by official commitees and recognized experts in the field, make clear there is still a debate going on regarding: (a) indication (risk profiles), (b) duration (varying from 1 to 5 years and even lifelong; national: NHG, 2003; MRD, 2005, and international: Paykel, 2001; Frank et al., 1990, Kupfer et al., 1992), and (c) dose (acute phase dose or lower maintenance dosages; Frank et al., 1993; Prien et al., 1984; Blier et al., 2007). Further, it is unclear whether doctors and patients are compliant to these guidelines. Finally, knowledge regarding costs related to (non) compliance to long-term treatment is
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 4
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT lacking. Because of these reasons, long-term follow-up examination of AD use in primary care is urgently needed in order to lessen under- and overprescription and to contribute to the development of evidence-based treatment guidelines. Therefore, we set out to examine determinants of duration and dose of AD use in a naturalistic follow-up of depressed primary care patients aged 18 to 65 of the NESDA (The Netherlands Study of Depression and Anxiety) cohort. This group consists of 1919 primary care patients with a lifetime diagnosis of major depression, of which 1106 have a current depression. The patients will be followed up to 8 years. Relevantie / Relevance Although knowledge concerning treatment by means of AD in the acute phase (until remission) and continuation phase (up to 3 months after remission) points at effectiveness, knowledge regarding optimal duration and dose of maintenance treatment (beyond 3 months after remission) in primary care is lacking, whereas the majority of depressive disorders is treated in primary care. This lack of knowledge presumably results in both over- and underprescription of AD, which is from the perspective of cost-effective disease management clearly undesirable. Consequences in case of a shorter than optimal duration of maintenance treatment by AD may be: avoidable relapses/ recurrences and health care and societal costs, and in case of longer than optimal duration of treatment, avoidable prolongation of adverse effects of AD and related health care costs. Therefore, gaining knowledge concerning characteristics of patients (not) using AD, AD usage patterns in terms of dose and duration, determinants of medication use, costs related to AD use, and whether AD use consistent with clinical guidelines is cost-effective, is urgently needed. This knowledge may provide a valuable contribution to the development of evidence-based AD prescription guidelines for GPs in order to optimize AD maintenance treatment. Kennisoverdracht, implementatie, bestendiging / Knowledge transfer, implementation, consolidation Doelstelling / Objective The general aim of this study is to examine the long-term use of antidepressants (AD) by primary care patients. The following objectives are central in this study. (1) The essential preliminary topic: How to assess reliably long-term AD usage? (2) Per predefined subgroup of patients (see background objective 2) we want to know: (a) What are numbers, sociodemographic characteristics and AD usage patterns in terms of dose and duration? (b) What are determinants of (dis-)continuation of AD use? (c) How is the depression course in the four groups? (3) What are the costs related to long-term AD use?
Plan van aanpak / Strategy Background objective 1 A crucial issue concerns examination of the way to assess long-term AD usage, and which measurement method or combination of measurement methods is most reliable. There are several sources to examine: (1) registration of data regarding the prescription of AD by the general practitioner
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 5
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT (GP), (2) data regarding the delivery of AD to the patient by pharmacists, and (3) self-report data obtained by questionnaire or interview of the actual AD usage by patients themselves. Data concerning (1) and (2) are obtainable from automized records held by GPs and pharmacists. With these sources one is able to determine whether AD is actually prescribed and delivered. Assessment of adherence to prescription can only be done by self-reports by patients and may be subject to bias. Comparison of these three sources of information may yield more insight in their reliability.
Background objective 2 Since knowledge of long-term AD usage is lacking, in particular in primary care, we want to provide descriptive epidemiological data concerning patterns of long-term AD use during a follow-up of 8 years in a natural setting in primary care. In general, we want to examine whether long-term AD treatment is prescribed to patients who are candidates for maintenance treatment according to the guidelines, whether patients adhere to treatment recommended by the guidelines, and we want to estimate the effectiveness of these treatments. We define four groups of AD users based on criteria derived from clinical guidelines. The NHG standard (2003) states maintenance therapy has to be considered in case of recurrent or chronic (at least 2 years) depression, whereas the Multidisciplinaire Richtlijn Depressie 2005, advises maintenance treatment in case of recurrent depression. The latter guideline recommends a duration of at least 1 year up to 3 or 5 years at the same dose as in the acute treatment phase. When ommitting the chronic depressed patients, this means the combined Dutch guidelines advise long-term AD treatment for at least one year after the acute and continuation phases at the same dose as in the acute treatment phase for patients who are diagnosed with a recurrent depression. Based on the logical combination of: (1) indication and (2) adherence to prescribed treatment, four usage profiles can be discerned and will be examined: (a) Patients who according to the guidelines are indicated for long-term treatment (i.e. patients with a recurrent depression) and who adhere to guideline consistent treatment (i.e. at least one year of AD usage after remission at the same dose of the acute phase treatment). (b) Patients who according to the guidelines are indicated for long-term treatment (i.e. patients with a recurrent depression), but who do not adhere to guideline consistent treatment (i.e. intermittent AD use, or AD use shorter than one year after continuation treatment with a dose lower than during the acute phase treatment). (c) Patients who according to the guidelines are not indicated for long-term treatment (i.e. patients with a minor or single depression), but who nevertheless receive and adhere to long-term treatment (i.e. at least one year after continuation treatment by AD at the same dose of the acute phase). (d) Patients who according to the guidelines are not indicated for long-term treatment (i.e. patients with a minor or single depression) and who do not adhere to guideline consistent maintenance treatment (i.e. intermittent AD usage, or AD use shorter than one year after continuation treatment at a dose lower than during the acute phase treatment). The latter group may seem irrelevant at first sight, but including this subgroup in the analyses may offer evidence that the guidelines rightly excluded these patients from long-term treatment, as judged by the actual depression outcomes. Per subgroup we want to answer three questions. (2.1) Description of the subgroups How many patients are discernable per group, what are their socio-demographic characteristics, and what are the characteristics in terms of dose and duration of their AD use (do patients adhere to the guideline recommended treatment)? Description of the numbers of long-term AD users is very important,
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 6
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT because research suggests that adherence to (acute and continuation phase) AD treatment is low, undertreatment by AD highly prevalent (cf. Wells et al., 1994; Furukawa et al., 2000) and associated with a higher risk of relapse/recurrence (Vergouwen et al., 2003). Finally, which usage profiles are discernable; for example: continuous users and intermittent users? Interestingly, two post hoc analyses of studies with naturalistic follow-ups of 2 and 5 years respectively suggest that effectiveness of continuous AD use does not differ from intermittent usage (Bockting et al., in press; Hasler et al., 2002). (2.2) Determinants of (dis-)continuation of AD use Which determinants influence the decision to continue or discontinue AD use, and the duration and dose of this use? A review of research in the last decades reveals many potential determinants of duration of AD use. Patient-related factors are found in several studies in primary care to be associated with early discontinuation, or less adherence to AD treatment. In general, attitudes towards AD use can be described as the balance between two types of patients’ beliefs: the perceived need of AD treatment and the perceived concerns regarding AD usage. Adherence was found to be highest in patients in which the necessity beliefs regarding AD use exceeded their concerns, and lowest when concerns exceeded necessity (Aikens et al., 2005ab). Examples of (a) perceived need beliefs are: the degree of feeling depressed and the perceived efficacy of AD, and (b) perceived concerns: adverse side effects, fear of drug dependence and feeling uncomfortable with taking antidepressant drugs, and wanting to solve problems without drugs (Demytternaere et al., 2001; Bull et al., 2002). Voils et al. (2005) found (c) social support, moderated by (d) locus of control, to be associated with adherence to AD treatment. High support is associated with better adherence in high internal locus of control patients (patients who belief their health is controllable) but not in low internal locus of control patients, whereas low support was associated with less adherence in low internal locus patients but not in high internal locus of control patients. Finally, an association between early discontinuation of AD use and (e) low socio-economic status was found (Hansen et al., 2004), but no association were found with the patient’s: (f) psychiatric history (Hansen et al., 2004), (g) neuroticism, and (h) depression severity (c.f. Lin et al., 1995; Melfi et al., 1998), whereas with regard to three other factors findings are contradictory, namely: (i) age, (j) gender (Meijer et al., Hansen et al., 2004) and (k) receiving concurrent psychotherapy (Pomerantz et al., 2004). Prescriber-related factors associated with early discontinuation are: (a) the prescribed duration itself, (b) the specialty area of the prescribers (GPs prescribe AD more often for shorter periods than psychiatrists), and (c) number of prescribers (the less the shorter the duration of use; Pomerantz et al., 2004; Meijer et al., 2004). Patient-prescriber interaction factors are also associated to early discontinuation, in particular insufficient communication between physician and patients as reflected by: (a) absence or a low number of contacts (< 3), and (b) unclear instructions about duration of AD usage and related adverse side effects, (Bull et al., 2002; Lin et al., 1995; Peveler et al. (1999). Medication-related determinants of (dis-)continuation of AD usage are: (a) type of antidepressant prescribed (SSRIs are longer used than TCAs), and (b) coprescription or a history of benzodiazepine usage (both associated with longer AD use) (Pomerantz et al., 2004; Meijer et al., 2004). (2.3) Depression course Finally, we want to describe the typical course of depression of the four defined groups of patients, and estimate the effectiveness of the actual (non) guideline conform treatments per group. Two outcome indicators will be used: time to recurrence and depression-free time. Because the NESDA design is observational by nature and not randomized, effectiveness of these (non) guideline conform treatments has to be estimated by means of propensity scores (see under statistical analyses). In these analyses covariates known to be of influence on the course of depression have to be incorporated. Former research has identified many different risk factors for shorter time to recurrence and/or lesser
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 7
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT depression-free time. These risk factors are potential candidates for these analyses: (a) number of previous depressive episodes, (b) duration of earlier episodes, (c) depression severity at initial assessment, (d) residual symptoms, (e) psychiatric comorbidity like dysthymia, anxiety disorders and substance abuse, (f) somatic comorbidity, in particular severity of pain, (g) personality-related risk factors like neuroticism, (h) poor social functioning, interpersonal problems and low social support, (i) stressful life events and long-term difficulties, (j) daily hassles, (k) unemployment, (l) low income, and (m) low level of education (c.f. Solomon et al., 2004 for a general overview, and Conradi et al., 2007 and Barkow et al., 2003 for primary care in particular). Finally, it is of importance to analyze more groups than those defined by the indication-criterion (recurrence) as provided by the Dutch guidelines for maintenance treatment, since for example both US guidelines (US Agency of Health Care Policy and Research) and recommendations done by experts in the field (Paykel, 2001; Keller, 2001; Blier et al., 2007) formulate broader and/or more specific indications for maintenance treatment. Two categories are discernable. (a) Clinical characteristics of the previous course of the depressive disorder itself (namely: multiplicity of prior episodes, recurrence within 1 year after of AD discontinuation, early age of onset or older age of onset, a severe or sudden life threatening episode within the past 3 years, residual symptoms at remission, relapse in the last year, and previous chronicity). (b) Patient-related risk factors for recurrence or a bad prognosis (namely: a family history of uni- or bipolar disorder, stressful life events; ongoing psychosocial stressors affecting daily functioning - like low socio-economic status, acrimonious relationships, or comorbid medical illnesses -, absence of social support, concomitant alcohol abuse, and comorbid anxiety disorders).
Background objective 3 Not only from a mental health perspective, but also from an economic perspective, the consequences of depression are substantial. It has been estimated that 1 to 2 % of national healthcare expenses in Western countries is spent on the treatment of depressive disorders (Polder et al. 2002). Important factors contributing to the considerable costs associated with depression are the high prevalence, early age of onset, the large risk of relapse and recurrence, and chances of depression becoming a chronic condition, leading to an extensive use of healthcare resources in subsequent years. When including costs outside the healthcare sector, like costs of productivity losses, the financial consequences of depression are considerably larger (Berto et al. 2000). Since depression has such a large impact on national healthcare budgets, information on the cost-effectiveness of interventions in depression, aiming to improve the relation between costs and health outcomes is highly relevant for decision-makers. In this study we want to gain more insight in the costs associated with long-term AD use in primary care. Costs we want to examine are medical costs: (a) the costs of AD, (b) health care use cost in: primary care (GP, physiotherapists etc.), outpatient care (psychiatrist, psychologist, social worker, addiction clinics, etc.) and inpatient care (hospitalization, daycare), and non-medical costs: (c) disability and loss of productivity, and (d) work-related loss of productivity.
Research plan Study design The choice for studying AD use in a naturalistic follow-up in primary care and not by means of a
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 8
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT randomized controlled trial (RCT) is not only determined by some of the research questions we want to address (the degree of guideline consistency of clinical practice and related cost-effectiveness), but by methodological considerations as well (Lavori et al., 1994). First, generalizibility of results of RCTs on AD treatment to daily practice may be restricted because of the highly selected and compliant patient samples used in RCTs. Second, it is almost impossible to address in a single RCT the clinically very important question of identification of the optimal duration of AD maintenance treatment in order to avoid potential successive recurrence. RCTs compare the effect of continued maintenance treatment versus discontinuation at one fixed point in time after remission. However, a comprehensive answer to the question ‘when to discontinue maintenance treatment?’ requires estimates of causal effects of the decision to drop treatment at each point in time after remission. Naturalistic follow-up studies do offer that opportunity and may result in a more narrow set of timing options of discontinuation, which may be supportive in designing new RCTs with which duration of maintenance treatment can be tested experimentally. Since naturalistic studies are non-randomized, estimation of efficacy has to be done by means of propensity scores (Lavori et al., 1994); see under ‘statistical analyses’. Sample NESDA is an eight-year longitudinal prospective cohort study that included 2981 respondents aged between 18 to 65 years and conduct assessments at baseline and after 1, 2, 4 and 8 years of follow-up. NESDA is designed to be representative of those with depression and/or anxiety in different health care settings. In this study we will focus on the primary care cohort of the study with a DSM-IV diagnosis of major depression (lifetime n=1919, current n=1106), dysthymia (lifetime n=106, current n=51) or minor depression (n’s = yet unknown). These patients were recruited from both primary and secondary setting at three participating universities (LUMC, VUMC and RUG). See for details of the inclusion procedure www.nesda.nl . Measurement instruments [Moet nog verder uitgewerkt/gecontroleerd worden] First, measurement goals are summarized; between brackets the actual measurement instrument is mentioned. Objective 1 Antidepressant medication Prescribed, delivered and actually used medications (registration by GPs and pharmacists, and self-report by patients respectively). Objective 2 Determinants of AD use Patient-related factors: (a) the patients’ perceived need of AD treatment (Perceived Need for Care Questionnaire; PNCQ an interview), (b) the patients’ perceived concerns regarding AD usage (‘Attitudes towards help measured by questions on trust in mental health care’, a self-report; and Patient evalution of care; QUOTE-depression a self-report), (c) social support (Close Person Inventory, and the Loneliness and Affiliation Scale; both self-reports), (d) locus of control (Mastery Scale a self-report), (e) socio-economic status (CIDI), (f) the patient’s psychiatric history (CIDI), (g) neuroticism (NEO-FFI), (h) depression severity (CIDI, Inventory of Depressive Symptomatology Self-Rated; IDS-SR a self rerport, and the Mood and Anxiety Symptom Questionnaire; MASQ self-report), (i) age (CIDI), (j) gender (CIDI), and (k) receiving concurrent psychotherapy (GP registration). Prescriber-related factors: (a) the prescribed duration of AD usage itself (GP registration), (b) specialty area of the prescribers (registration by pharmacists and GPs), (c) number of prescribers (registration by pharmacists), and (d) prescription in practices characterized by high prescription rates (GP registration). Patient-prescriber interaction factors: (a) absence or a low number of contacts (GP registration), and (b) unclear instructions about duration of AD usage and associated adverse side effects (‘Attitudes towards
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 9
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT help and questions regarding trust in mental health care by patients’; a self-report, and the PNCQ; an interview). Medication-related factors: (a) the type of antidepressant prescribed (GP and pharmacists registration, and self-report by patients), and (b) coprescription or history of benzodiazepines usage (GP and pharmacists registration, self-report by patients, and Benzodiazepine Dependence questionnaire BENDEP; an interview). Course of depression Outcome indicators are: (a) time to recurrence (Composite International Diagnostic Interview; CIDI, and the LIFE-CHART, both interviews), and (b) depression-free time (CIDI and LIFE-CHART). Co-variates Several co-variates (partly overlapping with those mentioned as patient-related factors associated with early discontinuation of AD usage) will be assessed with regard to analyses of the course of depression: (a) number of previous depressive episodes (CIDI and LIFE-CHART), (b) duration of earlier episodes (CIDI), (c) depression severity at initial assessment (CIDI, IDS-SR and MASQ), (d) residual symptoms, (e) co-morbid psychiatric disorders (CIDI), (f) chronic somatic disorders (interview), in particular pain (Chronic Graded Pain Scale; a self-report), (g) personality-related vulnerability: neuroticism (NEO-FFI; questionnaire) and childhood trauma (NEMESIS-interview), (h) social functioning, interpersonal problems, social support and partner status (Close Person Inventory, and the Loneliness and Affiliation Scale; both self-reports, and CIDI), (i) stressful life events (Life events Brugha questionnaire), (j) daily hassles (Daily Hassles; self-report), (k) unemployment (CIDI), (l) income (CIDI), and (m) level of education (CIDI). Objective 3 Cost measurement Direct costs associated with mental health care that are measured are: (a) the costs of AD (pharmacists registration; Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness; TiC-P interview), (b) health care use costs in primary care, outpatient care, inpatient care (all measured by the TiC-P interview and GP registration), and indirect costs: (c) disability and loss of productivity (WHO-DAS-II interview; and disability days by self-report), and (d) work-related loss of productivity (TiC-P interview). Statistical analyses To answer the research questions as formulated under objectives 1 to 3, several statistical methods will be used: descriptive statistics, ANOVAs, non-parametric tests, cross tabulations, Cox proportional hazard models, propensity scores and incremental cost-effectiveness ratios (ICER). (1) Objective 1, comparison of three sources for estimation of long-term AD usage, will require cross tabulations and depending on the distribution of the data, ANOVAs, and/or non-parametric tests. (2) Objective 2.1 patient characteristics and patterns of AD use in terms of duration and dose of treatment, will require regular descriptive statistics. (3) In order to analyze objectives 2.2 and 2.3, determinants of discontinuation of AD and the typical depression course of the different AD user groups, Cox proportional hazard models and propensity score analysis will be used. Herewith the association between patterns of use (duration of treatment and dose of medication), determinants of (dis-)continuation of use (factors related to characteristics of patients, prescribers, patient-prescriber interaction- and medication) and outcomes (relapse/recurrence and depression-free time) can be assessed. Propensity scores will be used because of the non-randomized nature of the observational design of NESDA (c.f. Lavori et al., 1994). This score is developed through a multivariate logistic model and can be used in different ways to adjust for the uncontrolled assignment of treatment to estimate the effectiveness of AD use. (4) Objective 3, cost-effectiveness, can be analyzed by means of incremental cost-effectiveness ratios (ICER). In cost-effectiveness analysis in general, costs and the primary health outcome associated with an intervention are used to calculate the incremental cost-effectiveness ratio relative to one or more alternatives (Drummond et al. 1997). The main focus of the current study is on the comparison of costs
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 10
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT and health outcomes between patients who receive AD treatment as prescribed by clinical guidelines concerning maintenance treatment and patients with one of the non guideline conform user profiles (see objective 2). Primary outcome measures will be time to recurrence and depression-free time. The method applied for calculating incremental cost-effectiveness ratios (ICER) is provided below. ICER = (CAD – CREF)/ (TRAD – TRREF) CAD = mean costs per patient in AD user subgroup CREF = mean costs per patient in reference group (other AD user subgroup or non-users) TRAD = mean time to recurrence in the AD group TRREF = mean time to recurrence in the reference group Expertise, voorgaande activiteiten en producten / Expertise, prior activities and products Expertise (geschreven door kandidaat AGIKO zelf): In de huisartspraktijk waar ik mijn keuzeco-schap heb gelopen kwam veel psychische en psychosociale problematiek voor. Deze patiënten, en dan met name de patiënten met klachten van somberheid en depressiviteit, hebben mij erg geboeid. Ik heb in deze periode veel geleerd over het beloop en de behandeling van depressie in de eerste lijn. Mijn interesse is erg breed, dit komt onder andere tot uiting in de zeer diverse presentaties die ik heb gegeven tijdens mijn co-schappen. Ik duik graag de literatuur in wanneer ik iets niet weet en ik vind het leuk om die kennis vervolgens met anderen te delen. Het geven van presentaties kan ik goed en vind ik leuk om te doen. Mijn medische kennis is boven gemiddeld. Tijdens de studie geneeskunde is het aanbod aan statistiek minimaal. Daarom heb ik via de rijksuniversiteit hierin een drieweekse cursus medische statistiek en een cursus SPSS gevolgd om deze kennis op een hoger niveau te brengen. Van 2002 tot en met 2004 heb ik mede de “Summerschool on pediatrics Groningen” georganiseerd. Ik heb het secretariaat verzorgd waarbij ik de deelnemers selecteerde en de contacten met ze onderhield. Hierbij heb ik veel internationale contacten opgedaan en heb ik met succes, middels overleg met diverse ambassades, visa voor een aantal deelnemers geregeld. Ik kan goed plannen en overleggen. Gedurende de eerste vier jaar van de studie geneeskunde heb ik in de jaarvertegenwoordiging gezeten. Hierin was ik voornamelijk verantwoordelijk voor de kritische beoordeling van de tentamens en in mindere mate voor de beoordeling van de colleges en practica. Hierdoor heb ik een kritische blik ontwikkeld en goed leren onderhandelen.
Voorgaande wetenschappelijke activiteiten en producten: Van september 2006 tot en met januari 2007 heb ik in Almelo onderzoek gedaan naar nierschade bij diabetespatiënten in de tweede lijn. Dit onderzoek heb ik zelfstandig opgezet en uitgevoerd onder supervisie van dr. A.J.J. Woittiez, internist-intensivist-nefroloog te Almelo, dit onderzoek heeft geresulteerd in de scriptie “Nierschade bij patiënten met diabetes mellitus in het Twenteborg ziekenhuis te Almelo.” Gedurende mijn keuzeco-schap heb ik mij verdiept in vitamine D tekort bij allochtonen, vanwege de grote populatie (>90%) allochtonen in de stagepraktijk. Na een korte literatuursearch heb ik een concept geschreven voor een informatiefolder voor patiënten. In mei 2007 heb ik naar aanleiding van een tweetal patiënten uit deze huisartspraktijk de klinische les “Twee patiënten met steeds meer vlekken” geschreven. Tijdens de eerste 4 jaar van de studie geneeskunde in Groningen, word je geacht om als student elke twee weken een korte opdracht mondeling te presenteren, dit beviel mij erg goed, je kunt je op die manier goed verdiepen in een onderwerp en leert al vroeg om kennis over te dragen. Behalve de presentatie moest je er elke keer ook een verslag van maken, ook dit kon ik goed. In de loop der jaren
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 11
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT heb ik hierbij het accent van de bronnen steeds meer van de studieboeken naar de wetenschappelijke literatuur weten te verleggen. Gedurende mijn co-schappen heb ik veelvuldig de wetenschappelijke literatuur geraadpleegd bij vragen en onduidelijkheden over problemen die ik in de praktijk tegenkwam. Aan de hand van korte literatuurstudies heb ik over een aantal zeer diverse onderwerpen presentaties gegeven voor de betreffende vakgroep en belangstellenden in het Twenteborg ziekenhuis te Almelo. Hieronder was onder andere een presentatie voor de vakgroep psychiatrie over “vrouwen en depressie”. Publicaties / Publications Berg MD Van den, Oldehinkel AJ, Haaijer-Ruskamp FM, Ormel J. Medicijngebruik door ouderen met depressieve klachten. Ned Tijdschr Geneesk, 2001; 145: 958-961. Bockting CLH, ten Doesschate MC, Spijker J, Spinhoven Ph, Koeter MWJ, Schene AH. Continuation and maintenance use of antidepressants in recurrent depression. Psycho Psychoth Som, in press. Bockting CLH, Schene AH, Spinhoven Ph Koeter MW, Wouters LF, Huyser J, Kamphuis JH. Preventing relapse/recurrence in recurrent depression using cognitive therapy. J Cons Clin Psychol. 2005;73: 647-657. Bockting CLH, Dijkgraaf MGW, Hakaart-van Roijen L, Koeter MWJ, Schene AH. Cost-effectiveness of relapse-prevention cognitive therapy in recurrent depression: a two year study. Submitted. Bockting CLH, Spinhoven Ph, Koeter MWJ, Wouters LF, Visser I, Schene AH, the DELTA study group. Differential predictors of response to preventive cognitive therapy in recurrent depression: a 2-year prospective study. Psychoth Psychosom. 2006; 75:229-236. Conradi HJ, De Jonge P, Kluiter H, Smit A, Van der Meer K, Jenner JA, Van Os TWDP, Emmelkamp PMG, Ormel J. Enhanced treatment for depression in primary care: long-term outcomes of a psycho-educational prevention program alone and enriched with psychiatric consultation or cognitive behavioral therapy. Psychol. Med. 2007; 37(6): 849-862. Conradi HJ, Jonge de P, Ormel J. Prediction of the three-year course of recurrent depression in primary care patients: Different risk factors for different outcomes. J Affect Disord, doi 10.1016 /j.jad.2007.04.017. Conradi HJ, Jonge de P, Ormel J. Multiple prior depressive episodes as treatment indication in primary care: CBT and psychiatric consultation perform better than the GP, submitted. Dobre D, van Veldhuisen, DJ, DeJongste MJL, Lucas C, Cleuren, G, Sanderman R, Haaijer-Ruskamp FM Prescription of beta-blockers in patients with advanced heart failure and preserved left ventricular ejection fraction. Clinical implications and survival. Eur J Heart Failure 9 2007; 280-286. Greving JP, Denig P, Van der Veen WJ, Beltman FW, Sturkenboom, MCJM, de Zeeuw D, Haaijer-Ruskamp FM. Does comorbidity explain trends in prescribing of newer antihypertensive agents? J Hypertens 2004 Nov; 22(11): 2209-15. Grigoryan L, Haaijer-Rysjamp FM, Burgerhof JG, Mechtler R, Deschepper R, Tambic-Andrasevic A, Andrajati R, Monnet DL, Cunney R, Di Matteo A, Edelsein H, Valinteliene R, Alkerwi A, Scicluna E, Grzesiowski P, Bara AC, Tesar T, Cizman M, Campos J, Lundborg CS, Birkin J. Self-medication with antimicrobial drugs in Europe. Emerg Infect Dis. 2006 Mar;12(3): 452-9. Kaymaz N, Os J van, Loonen AJM, Nolen WA. Long-term treatment of depressive disorder with antidepressants: A further meta-analysis (submitted). Marwijk Van HWJ, Wallace P, De Bock GH, Hermans J, Kaptein AA, Mulder JD. Evaluation of the feasibility, reliability and diagnostic value of shortened versions of the geriatric depression scale. Br J Gen Pract 1995; 45: 195-9. Marwijk Van HWJ, De Bock GH, De Jong JMA, Kaptein AA, Mulder JD. Management of depression in elderly general practice patients. Scand J Prim Health Care 1994; 12: 162-8. Meijer WE, Heerdink ER, Leufkens HG, Herings RM, Egberts AC, Nolen WA. Incidence and determinants of long-term use of antidepressants. European Journal of Clinical Pharmacology, 2004; 60: 57-61. Niessen WJM Stewart RE, Broer J, Haaijer-Ruskamp FM. Vermindering van gebruik van benzodiazepines door een brief van de eigen huisarts aan chronische grbuikers. Ned Tijdsch Geneeskd
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 12
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT 2005;149:356-361. Nolen WA. Gebrek aan bewijs bij de behandeling van belangrijke vormen van depressie. Nederlands Tijdschrift voor Geneeskunde 2005; 149: 1498-1501. Os TWDP Van, Van den Brink RH, Jenner JA, van der Meer K, Tiemens BG, Ormel J. Effects on depression pharmacotherapy of a Dutch general practitioner training program. J Affect Disord. 2002 Sep; 71(1-3): 105-11. Os TWDP Van, Van den Brink RH, Tiemens BG, Jenner JA, van der Meer K, Ormel J. Are effects of depression management training for General Practitioners on patient outcomes mediated by improvements in the process of care? J Affect Disord. 2004 Jun; 80(2-3): 173-9. Os TWDP Van, Van den Brink RH, Tiemens BG, Jenner JA, van der Meer K, Ormel J. Communicative skills of general practitioners augment the effectiveness of guideline-based depression treatment. J Affect Disord. 2005 Jan; 84(1): 43-51. Os TWDP Van, Van den Brink RH, Van der Meer K, Ormel J. The care provided by general practitioners for persistent depression. Eur Psychiatry. 2006 Mar; 21(2):87-92. Smit A, Kluiter H, Conradi HJ, Van Der Meer K, Tiemens BG, Jenner, JA, Van Os TWDP, Ormel J. Short-term effects of enhanced treatment for depression in primary care: Results from a randomised controlled trial. Psychol. Med. 2006; 36: 15-26. Spijker J, de Graaf R, Bijl RV, Beekman AT, Ormel J, Nolen WA. Duration of major depressive episodes in the general population: results from The Netherlands Mental Health Survey and Incidence Study (NEMESIS). British Journal of Psychiatry 2002; 181: 208-123. Spijker J, de Graaf R, Ormel J, Nolen WA, Grobbee DE, Burger H. The persistence of depression score. Acta Psychiatr Scand. 2006; 114: 411-416. Spijker J, de Graaf R, Oldehinkel AJ, Nolen WA, Ormel J. Are the vulnerability effects of personality and psychosocial functioning on depression accounted for by subthreshold symptoms? Depress Anxiety. 2006 Nov 16; Referenties / References Aikens JE, Nease DE, Nau DP, Klinkman MS, Schwenk TL, 2005a. Adherence to maintenance phase antidepressant medication as a function of patient beliefs about medication. An Fam Med.3(1), 23-30. Aikens JE, Kroenke K, Swindle RW, Eckert GJ, 2005b. Nine-month predictors and outcomes of SSRI antidepressant continuation in primary care. Gen Hosp Psychiatry 27(4):229-36. Barkow K, Maier W, Üstün B, Gänsicke M, Wittchen HU, Heun R, 2003. Risk factors for depression at 12-month follow-up in adult primary health care patients with major depression: An international prospective study. J Affect Disord, 157-69. Berto P, D’Ilario D, Ruffo P, Di Virgilio R, Rizzo F, 2000. Depression: Cost-of-illness Studies in the International Literature, a Review. Journal of Mental Health Policy and Economics, 3: 3-10. Blier P, Keller MB, Pollack MH, Thase ME, Zajecka JM, Dunner DL, 2007. Preventing recurrent depression: long-term treatment for major depressive disorder. J Clin Psychiatry, 68(3):e06. Bockting CLH, Doesschate MC, Spijker S, Spinhoven Ph, Koeter MWJ, Schene AH. Continuation and maintenance use of antidepressants in recurrent depression. in press. Bull SA, Hu XH, Hunkeler EM, Lee JY, Ming EE, Markson LE, Fireman B, 2002. Discontinuation of use and switching of antidepressants: influence of patient-physician communication. JAMA, 288:1403-9. Bultman DC, Svarstad BL, 2000. Effects of physician communication style on client medication beliefs and adherence with antidepressant treatment. Patient Educ Couns, 40(2):173-85. Conradi HJ, Jonge de P, Ormel J. Prediction of the three-year course of recurrent depression in primary care patients: Different risk factors for different outcomes. J Affect Disord, doi 10.1016 /j.jad.2007.04.017. Dawson R, Lavori PW, Coryell WH, Endicott J, Keller MB, 1998. Maintenance strategies for unipolar depression: an observational study of levels of treatment and recurrence. J Affect Disord, 49(1):31-44. Demyttenaere K, Enzlin P, Dewe W, Boulanger B, De Bie J, De Troyer W, Mesters P, 2001. Compliance
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 13
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT with antidepressants in a primary care setting, 1: Beyond lack of efficacy and adverse events. J Clin Psychiatry, 62(22):30-3. Drummond MF, O'Brien BJ, Stoddart GL, Torrance GW, 1997. Methods for the economic evaluation of Healthcare Programmes. Oxford University Press: Oxford. ESEMeD/MHEDEA 2000 consortium, 2004. Use of mental health services in Europe: Results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr. Scan. Suppl. 109, 47-54. Frank E, Kupfer DJ, Perel JM, Cornes C, Jarrett DB, Mallinger AG, Thase ME, McEachran AB, Grochocinski VJ, 1990. Three-year outcomes for maintenance therapies in recurrent depression. Arch Gen Psychiatry, 47(12):1093-9. Furukawa TA, Kitamura T, Takahashi K, 2000. Treatment received by depressed patients in Japan and its determinants: Naturalistic observation from a multi-center collaborative follow-up study. J Affect Disord, 173-9. Geddes JR, Carney SM, Davies C, Furukawa TA, Kupfer DJ, Frank E, Goodwin GM, 2003. Relapse prevention with antidepressant drug treatment in depressive disorders: A systematic review. Lancet, 361:653-61. Hansen DG, Vach W, Rosholm JU, Sondergaard J, Gram LF, Kragstrup J, 2004. Early discontinuation of antidepressants in general practice: association with patient and prescriber characteristics. Fam Pract, 21(6):623-9. Hasler G, Schnyder U, Klaghofer R, Angst J, 2002. Treatment of depressive disorders with and without medication - a naturalistic study. Pharmacopsychiatry, 35:235-38. Kaymaz N, Os J van, Loonen AJM, Nolen WA. Long-term treatment of depressive disorder with antidepressants: A further meta-analysis (submitted). Keller MB, 2001. Long-term treatment of recurrent and chronic depression. J Clin Psychiatry, 62:3-5. Kupfer DJ, Frank E, Perel JM, Cornes C, Mallinger AG, Thase ME, McEachran AB, Grochocinski VJ, 1992. Five-year outcome for maintenance therapies in recurrent depression. Arch Gen Psychiatry, 49(10):769-73. Lavori PW, Dawson R, Mueller TB 1994. Causal estimation of time-varying treatment effects in observational studies: application to depressive deisorder. Stat Med, 13: 1089-1100. Lin EH, Von Korff M, Katon W, Bush T, Simon GE, Walker E, Robinson P, 1995. The role of the primary care physician in patients' adherence to antidepressant therapy. Med Care, 33(1):67-74. Meijer WE, Heerdink ER, Leufkens HG, Herings RM, Egberts AC, Nolen WA, 2004. Incidence and determinants of long-term use of antidepressants. Eur J Clin Pharmacol, 60(1):57-61. Paykel ES. (2001). Continuation and maintenance therapy in depression. BMJ, 57:145-59. Polder JJ, Takkern J, Meerding WJ, Kommer GJ, Stokx LJ (2002). Cost of illness in the Netherlands. RIVM: Bilthoven. Pomerantz JM, Finkelstein SN, Berndt ER, Poret AW, Walker LE, Alber RC, Kadiyam V, Das M, Boss DT, Ebert TH, 2004. Prescriber intent, off-label usage and early discontinuation of antidepressants: a retrospective physician survey and data analysis. J Clin Psychiatry, 65(3):395-404. Prien RF, Kupfer DJ, Mansky PA, Small JG, Tuason VB, Voss CB, Johnson WE, 1984. Drug therapy in the prevention of recurrences in unipolar and bipolar affective disorders. Report of the NIMH Collaborative Study Group comparing lithium carbonate, imipramine, and a lithium carbonate-imipramine combination. Arch Gen Psychiatry, 41(11):1096-104. Simon GE, 2000. Long-term prognosis of depression in primary care. Bull World Health Organ, 439-45. Simon GE, 2002. Evidence review: Efficacy and effectiveness of antidepressant treatment in primary care. Gen Hosp Psychiatry, 24: 213-224. Solomon DA, Leon AC, Endicott J, Mueller TI, Corryell W, Shea MT, Keller MB, 2004. Psychosocial impairment and recurrence of major depression. Compr. Psychiatry, 45: 423-430. Vergouwen AC, Bakker A, Katon WJ, Verheij TJ, Koerselman F, 2003. Improving adherence to antidepressants: a systematic review of interventions. J Clin Psychiatry, 64(12):1415-20.
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 14
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT Viguera AC, Baldessarini RJ, Friedberg J, 1998. Discontinuing antidepressant treatment in major depression. Harv Rev Psychiatry, 5(6):293-306. Voils CI, Steffens DC, Flint EP, Bosworth HB, 2005. Social support and locus of control as predictors of adherence to antidepressant medication in an elderly population. Am J Geriatr Psychiatry, 13(2):157-65. Wells KB, Katon W, Rogers B, Camp P, 1994. Use of minor tranquilizers and antidepressant medications by depressed outpatients: Results from the Medical Outcomes Study. Am J Psychiatry, 151: 694-700.
Financiële gegevens / Financial data Geplande duur in maanden / Planned duration in months 48 maanden / months ZonMw budget Jaar / Year Kostenpost / Cost item
1
Personeel
9.300
15.000
15.100
15.800
0
0
0
0
55.200
Materieel
0
0
0
0
0
0
0
0
0
Implementatie
0
0
0
0
0
0
0
0
0
Apparatuur
0
0
0
0
0
0
0
0
0
Overig
0
0
0
0
0
0
0
0
0
9.300
15.000
15.100
15.800
0
0
0
0
55.200
Totaal / Total
2
3
4
5
6
7
8
Totaal / Total
Co-financiering / Cofinancing Naam co-financier / Name of cofinancier
Bedrag / Amount Status
Bijzondere gegevens / Additional information Vergunningen / Permits Vergunning nodig / Permit required? Ja / Yes
Vergunning verkregen / Permit obtained? Nee / No
Ja / Yes
Nee / No
METC/DEC
X
X
WBO
X
X
Biohazards
X
X
Andere vergunningen / Other permits Historie subsidieaanvraag / History grant application Deze aanvraag is eerder ingediend bij het programma /This grant application has previously been
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 15
Subsidieaanvraagformulier / Grant Application Form Dossier nummer / Dossier number:
CONCEPT submitted to the ZonMw programme: Projectnummer / Project number:
Aangemaakt door ProjectNet / Generated by ProjectNet: 25-06-2007 12:21
p. 16
Bijlage subsidieaanvraagformulier AGIKO Stipendia _ najaarsronde 2007 In deze bijlage worden aanvullende gegevens gevraagd die relevant zijn voor de beoordeling van de aanvraag, maar niet kunnen worden ingevuld in de standaard ZonMw-formulieren. U wordt verzocht dit document als bijlage (omgezet naar pdf-formaat) als attachment mee te zenden met uw elektronische aanvraag.
Compleet CV van de agiko U wordt verzocht uw complete CV (persoonsgegevens inclusief geslacht), opleidingsgegevens, werkervaring (zowel klinisch postacademisch als niet-klinisch postacademisch), publicaties en nevenactiviteiten van de kandidaat Agiko met deze bijlage mee te sturen.
ZonMw-begroting (alleen invullen als u in het standaardformulier in ProjectNet begrotingsjaren tekort komt) Sommige projecten hebben een looptijd van meer dan 8 jaren. Bijvoorbeeld wanneer een AGIKO nog het hele traject van een langdurige opleiding en promotieonderzoek moet volgen. In het standaardformulier van ZonMw zijn maar 8 begrotingsjaren opgenomen. Indien dit onvoldoende is, kan deze grotere tabel ZonMw-begroting in deze bijlage worden ingevuld. --Het standaard formulier was voldoende Projectjaar Kostenpost Personeel Materieel Implementatie Apparatuur Overig Totaal
1 n.v.t n.v.t n.v.t n.v.t
2 n.v.t n.v.t n.v.t n.v.t
3 n.v.t n.v.t n.v.t n.v.t
4 n.v.t n.v.t n.v.t n.v.t
5 n.v.t n.v.t n.v.t n.v.t
6 n.v.t n.v.t n.v.t n.v.t
7 n.v.t n.v.t n.v.t n.v.t
8 n.v.t n.v.t n.v.t n.v.t
9 n.v.t n.v.t n.v.t n.v.t
10 Totaal n.v.t n.v.t n.v.t n.v.t
n.v.t n.v.t n.v.t n.v.t
Onderzoekslijn waarop het project aansluit (max 25 regels): Hier beschrijft u de onderzoeksomgeving en onderzoekslijn waarop het project aansluit/waarin het is ingebed. --Bij Huisartsgeneeskunde in Groningen wordt al gedurende meerdere jaren onderzoek gedaan naar psychiatrie in de eerste lijn. Het onderzoek is ingebed in de Evidence Based Medicine in Practice onderzoeksgroep (EBM-P), behorende tot de Graduate School for Health Services Research (SHARE) van het Universitair Medisch Centrum Groningen.
Vooronderzoek (max 35 regels): Hier geeft u aan welk vooronderzoek reeds verricht is. Dit onderzoek sluit aan bij het NESDA_onderzoek. Er is al veel onderzoek gedaan naar het beloop van angst en depressie binnen de onderzoekspopulatie van NESDA. Zie de literatuurlijst.
Precieze rol agiko in het voorgestelde onderzoek (maximaal 10 regels). (Alleen verwijzen naar het in ProjectNet ingevulde projectvoorstel indien het daarin reeds duidelijk vermeld staat.) --De kandidaat AGIKO heeft aangegeven belangstelling te hebben voor wetenschappelijk onderzoek. Haar is gevraagd op welk gebied zij onderzoek zou willen doen, dit bleek de psychiatrie te zijn. Aangezien de Huisartsgeneeskunde in Groningen betrokken is bij de Nederlandse Studie naar Angst en Depressie (NESDA) zijn de mogelijkheden om deze kandidaat een onderzoeksplek te bieden onderzocht. Het voorgestelde onderzoek is ontstaan in overleg met meerdere disciplinegroepen. Waarom is deze subsidie nodig voor het voltooien van dit project (maximaal 10 regels): (Alleen invullen wanneer het onderzoek reeds 1 jaar of langer loopt.NB: de minimale tijd die het onderzoek nog in beslag moet nemen is 12 maanden (uitgaande van voltijds onderzoek)). --N.v.t. het project is nog niet gestart
Tijdschema van onderzoek en opleiding: Hier geeft u de fasering en tijdplanning aan die bij de uitvoering van het project gevolgd zal worden. Het AGIKO Stipendium beoogt fasen van opleiding en onderzoek zo goed mogelijk af te wisselen (‘sandwich-model’), ten einde maximale kruisbestuiving te bewerkstelligen en de AGIKO ervaring te laten opdoen met het combineren van onderzoeken klinische taken. Dit is mogelijk binnen de gestelde opleidingseisen van MSRC, HVRC of SGRC, waardoor bij deze instanties goedkeuring moet worden gevraagd voor het voorgestelde schema. Indien van toepassing vermeldt u ook de planning voor de patiënteninstroom.
Planning Projectjaar 2006 2007 2008 2009 2010 2011 2012 2013 2014
Opleiding (maanden, % werktijd)
Onderzoek (maanden, % werktijd)
4 maanden, 80% 8 maanden, 80% 4 maanden, 70% 12 maanden, 70% 12 maanden, 70% 8 maanden, 70%
4 maanden, 20% 8 maanden, 20% 4 maanden, 30% 12 maanden, 30% 12 maanden, 30% 8 maanden, 30%
Totaal: eerste jaar 0,2 en vervolgens gedurende 3 jr 0,3 fte Goedkeuring van bovenstaande planning door MSRC, HVRC of SGRC is verkregen aangevraagd -Het akkoord van het hoofd van de huisartsopleiding is hierin voldoende. Planning van patiënteninstroom in woorden/schema (indien van toepassing): Niet relevant, want in dit project wordt gebruik gemaakt van gegevens die al verzameld zijn. De kandidaat moet voornamelijk lezen, analyseren en schrijven.
Toekomstplannen kandidaat-AGIKO: (max. 16 regels) Dit dient door de kandidaat-AGIKO zelf te worden ingevuld en betreft zaken die relevant zijn i.v.m. deze aanvraag. O.a. de combinatie van klinisch wetenschappelijk onderzoek en klinische praktijk/ specialisme verdient aandacht. --In de toekomst wil ik de praktijk van de huisartsgeneeskunde blijven combineren met het doen van wetenschappelijk onderzoek. Ik blijf het liefst onderzoek doen in de richting van de psychologie /
psychiatrie in de eerste lijn. Er zijn nog veel vragen en onduidelijkheden op dat gebied en er zullen er naar aanleiding van dit onderzoek wellicht nog een aantal bijkomen. Het lijkt mij een uitdaging om te blijven werken aan de verbetering van de zorg voor mensen met psychische problemen, en dan met name depressie, in de eerste lijn. Door de hoge prevalentie heeft depressie niet alleen grote gevolgen voor de individuele patiënt, maar ook voor de maatschappij. Daarnaast zou ik mijn kennis graag delen. Ik zou het dan ook leuk vinden om onderwijs te gaan geven aan medisch studenten.
Oordeel opleider tot specialist m.b.t. de kandidaat-AGIKO: (max. 16 regels): Dit gedeelte dient door de opleider te worden ingevuld. Waarom is de kandidaat-AGIKO zo geschikt voor dit AGIKO traject? Wat zijn zijn/haarspecifieke vaardigheden? --Mevrouw E. Piek is per 1 september tot de huisartsopleiding toegelaten. Zij heeft de wens te kennen gegeven deze opleiding te combineren met een onderzoeksproject bij de disciplinegroep Huisartsgeneeskunde. Zij is zeer gemotiveerd voor de opleiding en het promotie-onderzoek. Op grond van het besproken onderzoekplan en het opleidingsplan tot huisarts en tot onderzoeker, verwacht ik dat zij deze combinatie succesvol zal doorlopen.
Oordeel onderzoeksleider m.b.t. de kandidaat-AGIKO: (max. 16 regels): Dit gedeelte dient door de onderzoeksleider te worden ingevuld. Waarom is de kandidaat-AGIKO zo geschikt voor dit AGIKO traject? Wat zijn zijn/haarspecifieke vaardigheden? ---Mevrouw E. Piek, geboren op 5 augustus 1983, is zeer gemotiveerd haar opleiding tot huisarts te combineren met promotieonderzoek. Ze heeft tijdens haar opleiding tot basisarts een cursus SPSS en statistiek gevolgd. Ze in de wetenschappelijke stage en in het keuze co-schap gemotiveerd geraakt zelf een (promotie)onderzoek uit te voeren, met name op het gebied van de psychiatrie in de eerste lijn. Hoewel ze nog geen wetenschappelijke output heeft laten zien, ben ik er in de voorbereidende gesprekken van overtuigd geraakt dat mevrouw Piek zich tot een goede onderzoeker zal ontwikkelen en dat zij dit in combinatie met de opleiding tot huisarts kan volbrengen.
Overige bijzondere gegevens In dit veld vermeldt u of er onderzoek met proefdieren, met gezonde proefpersonen of patiënten wordt verricht. U geeft aan wat het aantal benodigde proefpersonen is en wat de aard is van het mensgebonden onderzoek. Verder geeft u aan of, indien een vergunning van de METC of DEC vereist is, deze al is ontvangen.
METC/DEC Wordt onderzoek verricht met proefdieren? Wordt onderzoek verricht met gezonde proefpersonen? Wordt onderzoek verricht met patiënten? Hoeveel proefpersonen zijn nodig? Aard van het mensgebonden onderzoek (bijv. cohortstudie/interventiestudie):
Ja Ja Ja
Onderstaande vragen allen invullen indien genoemde vergunningen vereist zijn Is de vergunning voor de uitvoering van het project van de medisch-etische toetsingscommissie (METC) al verkregen, indien vereist? Is de vergunning voor de uitvoering van het project van de Dierexperimenten commissie (DEC) al verkregen, indien vereist?
Ja
Als de vergunning al verkregen is willen wij hiervan een kopie ontvangen. --N.v.t.
Nee -Nee-Nee--
Nee Ja Nee
CURRICULUM VITAE van mevrouw E. Piek Persoonlijke gegevens Naam : Piek Voornaam : Ellen Adres : Deldensestraat 97 Woonplaats : 7601 RW Almelo Geboortedatum : 5 augustus 1983 Geslacht : vrouw Nationaliteit : Nederlandse Burgerlijke staat : Ongehuwd Telefoon (privé) : 0546 – 538152 (mobiel) : 06 – 4108 4711 Opleidingen 2001 – 2007
1995 – 2001 Cursussen Februari – April 2005
Rijksuniversiteit Groningen Geneeskunde, diploma juni 2007 Dr. Nassaucollege te Assen Gymnasium, diploma 2001
G. J. Van Hoytemastichting ECG-cursus
Januari 2005
Rijksuniversiteit Groningen, Faculteit der Medische Wetenschappen Keuzecursus Medische statistiek
Oktober 2004
Rijksuniversiteit Groningen, Rekencentrum Cursus SPSS
November 2003
Oranje Kruis/Rijksuniversiteit Groningen EHBO-cursus
Werkervaring Februari – Mei 2007
Keuzecoschap Huisartsgeneeskunde Huisartspraktijk Zijp en v.d. Werff te Almelo Fulltime zelfstandig consulten gevoerd in praktijk met 90% allochtonen onder supervisie van een huisarts.
Oktober ‘06 – Januari ‘07
Keuzestage Centrale Huisartsenpost Centrale Huisartsenpost Almelo Gedurende 15 weken één avonddienst per week onder supervisie van een huisarts consulten gevoerd.
September ‘06 – Januari ‘07
Wetenschappelijke stage Twenteborg ziekenhuis Almelo, vakgroep interne geneeskunde, supervisor dr. A.J.J. Woittiez. Onderzoek naar nierfunctiestoornissen bij diabetes-patiënten onder behandeling in de tweede lijn.
2003 – 2005
Oproepkracht verzorgende C, Stichting Thuiszorg Icare Helpen van mensen thuis met ADL-activiteiten zoals wassen, aankleden en eten.
2002 – 2004
Organisatie Summerschool on Pediatrics Groningen
2002 – 2004
Bestuur Jeugdsociëteit in Assen (Vrijwilligerswerk)
Wetenschappelijke activiteiten Mei 2007 Klinische les “Twee patiënten met steeds meer vlekken” Januari 2007
Scriptie “Nierschade bij patiënten met diabetes mellitus in het Twenteborg ziekenhuis te Almelo”
Mei 2006
Presentatie “Chromosoomafwijkingen van de placenta” Presentatie voor vakgroep gynaecologie op basis van literatuuronderzoek.
Maart 2006
Presentatie “Foetale en neonatale hartritmestoornissen” Presentatie voor vakgroep kindergeneeskunde op basis van literatuuronderzoek.
Januari 2006
Presentatie “Re-excisie vs. ablatio bij tumorpositieve randen na lumpectomie in verband met mammacarcinoom” Presentatie voor vakgroep chirurgie op basis van literatuuronderzoek.
November 2005
Mini-scriptie “KNO-uitingen van M. Wegener”
September 2005
Presentatie “Vrouwen en depressie” Presentatie voor vakgroep psychiatrie op basis van literatuuronderzoek.
Mei 2005
Casus pro diagnosi “Acromegalie” Presentatie internoïde specialismen op basis van patiëntencasus en literatuur.
Vaardigheden In bezit van rijbewijs B. Competenties Gedurende mijn keuzeco-schap heb ik gemerkt dat ik veel affiniteit heb met psychiatrie in de 1e lijn. In die huisartspraktijk kwam veel psychische en psychosociale problematiek voor, ik vond het leuk om deze patiënten te begeleiden. Tijdens mijn werk bij de thuiszorg, mijn keuzeco-schap en de organisatie van de summerschool heb ik gemerkt dat ik zowel goed zelfstandig als in een team kan werken. Referenties J.D. Zijp, huisarts Huisartspraktijk Zijp en van der Werff Bellavistastraat 5a Almelo Dr. A.J.J. Woittiez, Internist-intensivist-nefroloog Twenteborg Ziekenhuis te Almelo Zilvermeeuw 1 Almelo
Antonius Deusinglaan 1, Postbus 196, 9700 AD Groningen
Universitair Medisch Centrum Groningen Disciplinegroep Huisartsgeneeskunde
hoofd Prof. dr. K. van der Meer
Onderafdeling Aan:
Hoofd dr. F. Baarveld
E. Piek Deldensestraat 97 7601 RW Almelo
Contactpersoon Joke Hazenberg Telefoon 050-363 8386 Fax 050-363 7445 E-mail
[email protected] Website www.huisartsopleiding.rug.nl Bijlage(n) Kenmerk Cc
JH/07/154
Datum 23 m ei 2007 Onderwerp Uw sollicitatie voor de huisartsopleiding
Geachte mevrouw Piek, Hiermee delen wij u mede dat u bent toegelaten tot de huisartsopleiding, startdatum 1 september 2007.
Met vriendelijke groeten,
Dhr. Peer van Haaren, voorzitter sollicitatiecommissie
Universitair Medisch Centrum Groningen
Disciplinegroep Huisartsgeneeskunde (Sector F) Voorzitter:
Prof.dr. K. van der Meer
Telefoon:
050-3632970
Fax
050-3632964
e-mail
[email protected]
Datum: 21 juni 2007 Onderwerp: aanstelling
Mevrouw E. Piek, geboren op 5 augustus 1983, is per 1 september 2007 aangenomen als huisarts in opleiding/ onderzoeker bij het project “determinanten van het gebruik van anti-depressiva in de huisartspraktijk”. Het onderzoek zal, net als de opleiding, starten per 1 september 2007.
Prof.dr. K. van der Meer