Applicability and effectiveness of the Dutch Multidisciplinary Guideline for the treatment of Anxiety Disorders in everyday clinical practice (SIGMA). Predicting, and coping with, non-response to a treatment guideline.
September 2004
Index 0. 1. 2. 3. 4. 5. 6. 7. 8. 9. 9.1.1 9.1.2 9.1.3 9.1.4 9.2 9.2.1 9.2.2 9.2.3 9.2.4 9.2.5
9.2.6 10. 11.
Summary Applicants Research site Location Composition of the research group Projectleader Problem definition and main research questions Relevance Background Methods and activities Phase 1: Implementing the guideline Implementing the Multidisciplinary guideline for Anxiety Disorders Target group Evaluation of the process of implementation
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p. 9 p. 10 Phase 2: Effectiveness of the guideline and Phase 3: p. 10 Chronic patients
Treatment Evaluation of the effectiveness of the guideline Patient population and screening Design Measures General measures used at Pre-test General measures used at Post-test Disorder specific measures used at Pre- and Posttest Clinical decision points Necessary time invested by the patient Statistical analyses and power considerations Time schedule References Appendix A Patiënten informatie Toestemmingsverklaring
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Summary
Title
Applicability and effectiveness of the Dutch Multidisciplinary Guidelines for the treatment of Anxiety Disorders in everyday clinical practice (SIGMA). Predicting, and coping with, non-response to a treatment guideline.
Objectives
1) To decrease the degree of under- and inadequate treatment of patients with anxiety disorders. 2) To facilitate the implementation of the multidisciplinary guideline for anxiety disorders, indirectly introducing relatively new principles like evidence based medicine, transparency and monitoring of care. 3) To improve the knowledge of the limitations of treatments and characterise treatment resistant patients and their needs.
Design
A naturalistic study with an uncontrolled design, with pre-, post- and follow-up tests.
Research site Institute: Adhesie, GGZ Midden-Overijssel. Unit: ‘Sector gespecialiseerde GGZ Almelo’. Sample
180 patients of 18 years and older who are referred to the RIAGG Almelo and who fulfil the DSM-IV criteria for a panic disorder with/without agoraphobia, social phobia, obsessive compulsive disorder, generalised anxiety disorder, posttraumatic stress disorder, or a specific phobia, as is assessed by using the Mini International Neuropsychiatric Interview, version 5.0 (MINI, Sheehan et al., 1994).
Method
The complete study can be said to comprise 3 phases, which run after one another subsequently and in which different activities can be distinguished: Implementing the guideline: Before the implementation of the guideline, the degree of compliance to the guideline in recent years will be determined. Subsequently, a tailored implementation plan based on a diagnostic analysis of the team will be used to facilitate the implementation on the guideline. Next, the degree of compliance to the guideline will be closely monitored and factors associated with deviation to the guideline will be looked into. The effectiveness of the guideline: The effect of the treatment will be evaluated with the use of disorder specific measures and more general measures, that allow us to determine the overall degree of wellbeing of the patient. Chronic patients: If there is no full remission after 2 years of treatment, the remaining needs of the patient and the treatment options left will be looked into by a special 'outtake team' (Hoogduin et al., 1997).
Interventions The aim of this study is to facilitate the use of the Dutch Multidisciplinary Guideline for Anxiety Disorders, which reflects a multidisciplinary consensus of all available treatments and is based on the principles of evidence based medicine. The interventions for which the use is advocated in this study are all evidence-based, or at least expert based, treatment options. Outcome measures
The outcome measures consist of measures to determine the degree of present general psychopathology, depressive symptoms and of several disorder specific measures to determine the extent and the severity of the anxiety complaints. Besides these, measures to determine the patients quality of life, to appraise the patients degree of social- and occupational- functioning and a measure that expresses the patient’s degree of satisfaction with the treatment will be used.
Timetable
Pre-tests before the beginning of treatment; post tests after the end of treatment, or at least after 2 years of treatment; and a follow-up assessment one year after the post-test has taken place. The inclusion of patient is planned to start in January 2005. Analysis and the report of the complete study will be completed in 2010. 2
1. Applicants Prof. dr. A.J.L.M van Balkom Vrije Universiteit Amsterdam Medisch Centrum Valerius Kliniek Postbus 7057 1007 MB Amsterdam, Netherlands Telephone: +31(0)205736600 Drs. M.K. van Dijk, psychologist Adhesie - GGZ Midden-Overijssel MFE RIAGG Almelo Hanzelaan 1 7600 AJ Almelo, Netherlands Telephone: +31(0)546542424 Fax +31(0)546542421 email:
[email protected] 2. Research site Adhesie, GGZ Midden-Overijssel Deventer Postbus 5003 7400 GC Deventer, Netherlands Telephone: +31(0)570639604 3. Location Adhesie, GGZ Midden-Overijssel Sector Gespecialiseerde GGZ Almelo Location Almelo: RIAGG Almelo Hanzelaan 1, 7600 AJ Almelo 4. Composition of the research group Adhesie: Drs. M.K. van Dijk, psychologist Dr. D.B. Oosterbaan, psychiatrist Dr. M.J.P.M. Verbraak, clinical psychologist / psychotherapist Vakgroep psychiatrie Vrije Universiteit / Instituut voor extramuraal geneeskundig onderzoek (EMGO) Amsterdam: Prof. dr. A.J.L.M van Balkom, psychiatrist Dr. M.W. van Tulder, MTA-expert * Other: Prof. dr. R.P.T.M Grol, Centre for Quality of Care Reseach (WOK) * Prof. dr. F.A.M. Kortmann, Katholieke Universiteit Nijmegen * Drs. H. Verburg, Trimbos Instituut * * member of the study advisory board.
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5. Projectleader Prof. dr. A.J.L.M van Balkom Vrije Universiteit Amsterdam Medisch Centrum Valerius Kliniek Postbus 7057 1007 MB Amsterdam Telephone: +31(0)205736600
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6. Problem definition and main research questions To improve the standard of care in the Netherlands, a guideline for the treatment of anxiety disorders is recently developed in our country recently. It reflects a multidisciplinary consensus of all available treatments for anxiety disorders based on the principles of evidence based medicine. As the current state of care for patients with anxiety disorders is far from optimal, a more widespread recognition and knowledge of effective treatments is likely to result in a reduction in the burden of illness (Cowley, 1997). The implementation of a guideline reflecting evidence based treatment methods, is an end to this need. However, research data are not implemented easily in daily practice. From implementation studies in other fields of psychiatry, it is known that implementation of guidelines is a difficult process, of which the success is dependent on a complex of patient, therapist and context variables (Peters et al, 2003). This project aims to evaluate the process of implementation of the guideline, hoping to gain insight in factors that hamper or help advance the implementation process and to identify useful interventions in promoting compliance to the guideline in a setting that is representative for Dutch non-academic outpatient clinics. We are unaware of published reports showing the impact on treatment outcomes of implementing this or other treatment guidelines for anxiety treatment in mental health settings. Therefore next to the evaluation of the process of implementation, the effect of the guideline on the clinical status of the patient is assessed. We also aim to identify variables of non-response that are important for clinical practice and can lead to adjustment of the guideline to special risk-factors or subgroups. Our project will give special attention to patients who do not seem to benefit from certain and several treatment steps recommended in the guideline. Research in chronic anxiety disorder patients is very scarce. We will evaluate the use of an ‘outtaketeam’ with patients who do not show a full remission after al steps of the treatment protocol have been made. All non-responding patients will be interviewed to determine their needs. A semi-structured interview will be developed to sample characteristics and list the needs for further care as indicated by the patients themselves and their therapists. These data can be a start for the nearly undeveloped care for patients with chronic anxiety disorders. Our project aims to evaluate the implementation, applicability and effectiveness of the Dutch multidisciplinary guideline for anxiety disorders in a setting that is representative for the Dutch nonacademic outpatient clinics. Taken together, the data of this project can help to determine and implement adequate cure and care for anxiety disorder patients in clinical practice. In this study the following research questions will be investigated: 1. (a) What are factors that hamper or facilitate the implementations of the Dutch Multidisciplinary Guideline for the treatment of Anxiety Disorders? (b) What kind of interventions can be used to facilitate the implementation of the Dutch Multidisciplinary Guideline for the treatment of Anxiety Disorders? 2. (a) What is the effectiveness of working according to the Dutch Multidisciplinary Guideline for the treatment of Anxiety Disorders, as is determined by the change in the symptoms, the functional status of the patient and more general measures of quality of life? (b) What are reasons for clinicians to deviate from the Dutch Multidisciplinary Guideline for the treatment of Anxiety Disorders? 3 (a) What characteristics correlate with becoming a chronic anxiety patient? (b) What are the needs of patients with a chronic anxiety disorder?
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7. Relevance In the Netherlands about 1.3 million people suffer from an anxiety disorder. A significant raise in the incidence of these disorders is found over the past decade (RIVM, 2003). Anxiety disorders markedly compromise quality-of-life and psychosocial functioning in several functional domains (Mendlowicz & Stein, 2000). Despite the availability of effective psychotherapeutic and pharmacological treatments, only 27% of individuals with a current anxiety disorder diagnosis receive treatment (Greenberg et al, 1999). Furthermore, a lot of patients that do receive treatment, do not receive adequate pharmacotherapeutic or psychotherapeutic treatment. Though about 90% of anxiety disorder patients treated in the Netherlands are offered psychotherapy, only one third of them receive an evidence based form of psychotherapy in the form of directive therapy (Hutschemakers et al, 2001). In an American study in primary care, only 22% of panic disorder patients had received adequate medication (type and/or dose) (Roy-Birne et al, 1999). A study in various European countries including The Netherlands revealed that anxiolytic drugs, as compared to the scientifically more preferred psychopharmacological treatment with antidepressants for anxiety disorders, are prescribed too often in primary care settings (Weiller et al, 1998). As far as we know, there are no recent data available about the prescription nowadays of drugs in the Netherlands outpatient clinics. Foreign studies suggest that psychopharmaceutical care for patients in outpatients settings is far from optimal (Swinson et al, 1992; Reich et al, 1994). Treatment guidelines based on research evidence are an effort helping physicians and therapists to make decisions in the complexity of clinical practice among the ever-expanding range of therapeutic options. As the current state of care for patients with anxiety disorders is far from optimal, a more widespread recognition and knowledge of effective treatments is likely to result in a reduction in the burden of illness (Cowley, 1997). This could also confer benefits in terms of a reduced extent or severity of psychiatric conditions that often occur secondary to anxiety disorders, such as depression or substance abuse (Greenberg et al, 1999). Finally, the use of a guideline will hopefully result in a more efficient allocation of cure and care, thus preventing long treatments and waiting lists. The undertreatment of anxiety disorders in combination with the availability of effective treatments justifies the research on the applicability and effectiveness of this guideline in the daily practice of mental healthcare. Furthermore, this research project fits the recent scientific developments and the recommendations of the ‘Raad van Gezondheidszorgonderzoek’, in which the need for practically orientated research is stressed (RGO, 1999). Research performed in daily clinical practice, in a nonacademic setting is very valuable. This type of research allows us to pass judgement on the external validity of ‘evidence-based’ treatments (Borkovec et al, 1998; Goldfried et al, 1998).
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8. Background The desire to promote evidence based medicine has lead to the development of treatment guidelines. These guidelines are developed to aid the clinician in making decisions in daily clinical practise, which as a result of an ever-expanding range of therapeutic options is becoming more and more complex. The use of practice guidelines in healthcare is expected to increase the use of effective therapeutic interventions and to reduce the inappropriate variation in clinical practice. In the Netherlands, following two monodisciplinary guidelines (Neomagus, NHG, 1997; Van Balkom et al, Ned. Ver. voor Psychiatrie, 1998), an unique guideline has been developed recently revealing a consensus of various professionals as well as patients (Werkgroep Angststoornissen, 2003). However, it is known that research data are not easily generalised to and implemented in daily practice (Drake et al, 2001). Both patient variables (e.g. comorbidity, treatment preference, psychosocial stressors), therapist variables (e.g. capacities, affinity, experience, knowledge) and system variables (e.g. availability, time, workload) hamper the compliance with and effectiveness of a guideline. From several studies it is clear that passive dissemination of guidelines is generally ineffective (Azocar et al, 2003). The effectiveness in the field of diverse active methods of implementation is inconsistent (Grol & Grimshaw, 2003; Suppes et al, 2003; Gifford et al, 1999). A well-considered implementation plan may resolve some of the problems mentioned above. We aim to design a tailored implementation plan based on a diagnostic analysis of the team. The implementation toolkit will at least include the making of a stepby-step practice manual (‘zorgprogramma’) to ease the use of the guideline in the individual patient, a training and ongoing supervision (Grol et al, 2001). We will explore the degree of compliance to the guideline, look into the actual reasons for deviation to the guideline as well as into patient, therapist and system variables predicting deviation. Future efforts to implement practice guidelines in mental healthcare may profit from the knowledge gained by this study. The desired end result of the project is the determination of several recommendations facilitating the implementation of the multidisciplinary guideline for anxiety disorders in the Netherlands. As mentioned elsewhere, there is a lack of research that focus on the effectiveness of treatments in the field of clinical practice. By applying the guideline to all patients with anxiety disorders that are referred to the RIAGG Almelo, we aim to create a study-population that is representative for the average nonacademic outpatient setting. An interesting extra characteristic of our patient population is that 25% are migrants with a Turkish background, making it possible to perform a subgroup-analysis. We aim to identify predictive variables for non-response that are easy to determine at the start of treatment. Identification of these factors is important for clinical practice and can lead to adjustment of the guideline to special risk-factors or subgroups. Because we are unaware of published reports showing the impact on treatment outcomes of implementing guidelines for the treatment of anxiety disorders in mental health care settings, this study is the first to answer the question if the successful implementation of practice guidelines is indeed beneficial and leads to better care.
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9. Methods and activities As is mentioned in the summary the complete study can be said to comprise 3 phases, which run after one another subsequently and in which different activities can be distinguished: The first phase consists of implementing the Multidisciplinary guideline for the treatment of Anxiety Disorders. Paragraphs 9.1 refers to this phase of the study. Subsequently, in the second phase, the effectiveness of the guideline will be evaluated. This phase is dependent on the successful implementation of the guideline at phase 1. In the third and last phase of the study , the remaining treatment options and needs of patients who don’t show a full remission of their complaints after 2 years of treatment will be looked into by a special 'outtake team' (Hoogduin et al., 1997). Paragraph 9.2 refers to the second and third phase of the study. 9.1
Phase 1: Implementing the guideline
9.1.2
Implementing the multidisciplinary guideline for anxiety disorders
Point of departure is the eclectic implementation-model of Grol & Wensing (2001), that integrates elements of several theories and facts on successful implementation. The model advocates a thorough preparation and planning of the process of implementation, as well as a systematic approach. Five successive stages in the process of change are defined: orientation, insight, acceptance, change and maintenance of change. These stages contain elements of for example Prochaska's transtheoretical model and Rogers' innovation-diffusion theory. To start with, an thorough analysis of the target group (the multidisciplinary anxiety disorders team) and setting (RIAGG Almelo) is made. This analysis reveals information on the position of the target group and setting in the process of change. Subgroups in the target groups are identified depending on their stage in the process of change. For each stage beneficial and interfering factors for implementation on the level of the individual caregiver, social-, logistical-, and economical level are identified. In aid of the diagnostic analysis of the Anxiety Disorder team of the RIAGG Almelo and its organisational setting, : 1) A 'social chart' will be made of all parties involved in the implementation process listing their targets and views. 2) The current way of treating anxiety disorder patients in the team is determined. To identify the most important deviations of the present care compared to the care recommended by the guideline, data on the actual received care will be collected from records of anxiety patients that started their treatment in the team between January 2002 and July 2003 (about 160 patients). As much as possible, information on the indicators mentioned below is gathered. 3) All 15 team members will be interviewed individually to identify their attitude to the use of the guideline (the experience and directives of Peters et al (2003) with this type of analysis will be taken into account). Their 'readiness to change' according to Prochaska's stages is determined (Prochaska & Velicer, 1997). 4) For all team members, deficits in expertise and knowledge to work adequately with the guideline will be listed. 5) Barriers in the structural environment, for example secretarial assistance, team meetings and communication lines are identified. 6) An inventarisation of the identified interfering factors and beneficial factors on the different levels (patient, therapist, organisation). We expect, for example, that the broad experience of the team with cognitive behavioural therapy and the progressiveness of the organisation in the development of specific programs of care (e.g. a study on the stepped care model) will ease the implementation. Several team members participated in treatment studies. These include controlled studies on the treatment of panic disorder, application of brief therapy and the evaluation of a stepped care model in anxiety and depressive disorders. We also expect that special attention is needed to reduce the resistance of some therapists against the influence of the guideline on their clinical decisions. Many studies have demonstrated that the implementation of guidelines is a complex process. It appeared that the clinical routine of professionals is very difficult to change, even if they judge the guideline to be good, current and applicable (e.g. Waldorff et al, 2003; Dewan et al, 2003). Also, there is a considerable variation between the different professional
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groups in clinical decision making and adherence to guidelines (Tiemeier et al, 2002). Many articles have been written on the barriers of (mainly physician's) adherence to guidelines, revealing a wide range of problems on the level of the knowledge, attitude and behaviour (Cabana et al, 1999). Though studies on guideline adherence may not be generalisable, (since barriers in one setting or profession may be less present in another), we realise that our diagnostic analysis will probably reveal that much time and energy has to be invested at the level of the individual team member. Concerning this topic, literature shows that it is important to take into account the perspective of the therapists. They must be convinced that the practice is worth learning. To achieve this, several recommendations are made in literature. In addition to research support, therapists can be influenced by impressions of the interventions seen in action, the idea that the guideline will improve clinical area's where they currently feel they are ineffective and to discussion on the rationale and concerns of the proposed practice (Torrey et al, 2001). 7) Indicators of successful implementation will be deduced from the summary in step 6 above. Depending on the results, strategies and interventions required for the implementation will be determined. Generally speaking, we need a set of different interventions directed at different levels. If necessary, interventions will undergo pilot testing. A set of indicators will also be inferred from the analysis to enable an evaluation of the success of the implementation plan. Goals are to be defined in advance of the implementation project including criteria for achievement. Subsequently, a concrete implementation plan will be developed, including a time-schedule. Members of the target group and organisation will be involved in this process. During the project the application of the innovation is monitored. According to a Demming cyclus (Plan-Do-Check-Act)continued adjustment of the applied strategies is possible. Though the exact implementation plan can only be deduced from the result of the diagnostic analysis, some essential interventions that will be part of the implementation toolkit beforehand are summed below. 1) Development of a practical step-by-step manual fitting the guideline, available on paper and internal computer network (intranet). The likelihood that a busy therapist will refer to guideline material is greatly enhanced by efficient access to information, ideally during the clinical encounter itself (Mellman et al, 2001). The manual will be field-tested by all disciplines of the team in a pilot project including 30 patients. Necessary adjustments to the local situations are made, like the addition of reminders and feedback in the existing recurrent patient evaluation structure. 2) A series of plenary meetings to disseminate the underlying knowledge and gain enthusiasm in the team for the decisions made. 3) Depending on their stage of readiness to change (Prochaska) interventions at the individual level are considered to improve motivation. 4) Educational meetings multidisciplinary as well as mono-disciplinary. 5) Adaptation of existing educational material for patients and their families. 6) Development of a flow chart on which the course of the patient through the guideline can be registered. This chart will be part of the regular evaluation of the patient in the team, to give feedback to the therapist 7) Structural barriers will be resolved as much as possible. 8) The implementation programme is described according to a standardised framework that is used in a large number of implementationstudies (Hulscher et al, 2001) and is for instance based on advice of the Cochrane Effective Practice and Organisation of Care Group (EPOC, Bero et al, 1998). 9.1.2 Target group Target group: All 15 members of the specific anxiety disorders team of Adhesie RIAGG Almelo, consisting of 1 psychiatrist, 1 psychiatrist in training, 4 psychologists, 1 psychologist in training, 3 psychotherapists, 3 psychiatric nurses (2 nurse specialists, 1 social psychiatric nurse), 2 psychiatric nurses in training. The team comprises the complete range from beginning to very experienced professionals.
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9.1.3 Evaluation of the process of implementation As mentioned above, a set of indicators is constructed in the phase of the diagnostic analysis to evaluate the various domains in the process of implementation. The indicators are mainly derived from the guideline itself. Based on its recommendations indicators reflecting the quality and efficiency are selected. Main indicators will be the percentage of patients that are adequately treated with cognitive-behavioural therapy, cognitive therapy and medication. These indicators will be specified in detail according to the criteria of Casparie & Hommes (1997) on usefulness, relevance and validity. For every indicator criteria are established (for example: essential elements of cognitive-behavioural therapy; dose and duration of pharmacotherapy). Finally, a norm is set for the different indicators to define the targets of implementation. These norms will be based on results of controlled studies and the results of the prestudy on the records of patients treated in the team from January 2002 till July 2003. Adherence and knowledge of the guideline will be tested with a series of case-vignettes at pre-test, end of the study and 1 year follow-up. Workload and perceived work stress will also be assessed at pre-test, posttest and follow-up. Therapist will be asked about their satisfaction with and the applicability of the guideline regarding the treatment of the individual patient. At the organisational level the availability of treatment options and length of waiting list will be registered. 9.2 Phase 2: Effectiveness of the guideline and Phase 3: Chronic patients 9.2.1 Treatment As mentioned before the aim of this study is to facilitate the use of the Dutch Multidisciplinary Guideline for Anxiety Disorders, which reflects a multidisciplinary consensus of all available treatments based on the principles of evidence based medicine. The interventions for which the use is advocated in this study are therefore all evidence-based, or at least expert based, treatment options. More information about the Dutch Multidisciplinary Guideline for Anxiety Disorders and the recommended interventions can be found at www.ggzrichtlijnen.nl. 9.2.3 Evaluation of the effect of the guideline As a primary efficacy measure the achievement of remission (defined according to disease-specific criteria including diagnostic criteria, severity and functional status) in every patient is determined by an independent assessor. (post-test will take place at termination of treatment, or after a maximum of 2 years of treatment. A follow-up assessment is planned 1 year after post-test). Next to extensive assessments at pre-test, post-test and 1 year follow-up, a limited assessment (monitoring) is made at essential steps in the guideline (for example change from medication to cognitive therapy). Data collected at pre-test comprise demographic variables, risk factors, general and specific psychiatric symptoms, comorbidity, personality traits, satisfaction, quality of life and functioning. 9.2.4 Patient population and screening: RIAGG Almelo serves the provincial town Almelo (about 78.000 inhabitants) and a rural area (about 60.000 persons). It is the main provider of mental health care in this region. Patients are referred by one of the 81 primary health physicians of the region. RIAGG Almelo is part of a multifunctional unit containing also (semi-)clinical settings in Almelo. In this study, all patients of 18 years and older referred to the RIAGG Almelo, that fulfil the DSM-IV criteria of a main diagnosis of: panic disorder with/without agoraphobia, social phobia, obsessive compulsive disorder, generalised anxiety disorder, posttraumatic stress disorder, specific phobia or hypochondriasis are eligible for inclusion in the study. The Mini International Neuropsychiatric Interview, version 5.0 (MINI, Sheehan et al, 1994) is used to assess DSMIV diagnoses. The use of the MINI is part of the regular diagnostic procedure within the RIAGG. According to the multidisciplinary guidelines, no exclusion criteria are formulated for this study. Patients will be asked for informed consent. As the number of patients with a DSM-IV anxiety disorder diagnosis referred to the team in 2003 was 142, and the number of referred patients is still increasing, it appears
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realistic to include 180 patients in 1.5 year, even if we take into account a 10% of refusers. We expect only 10% refusals because all patients receive an open-labelled evidence-based treatment to their preference (according to the guidelines). The only burden is the filling out of questionnaires at pre-test, post-test and follow-up test. 9.2.5 Design An uncontrolled design with pre-test and post-test during a maximum of two years per patient. One year after the post-test a follow-up test is done, measuring the effectiveness of and the degree of compliance to the anxiety disorders guideline. 9.2.6 Measures General measures used at Pre-test Instruments used at pre-test: Symptom Checklist-90-R (General psychopathology, anxiety and phobia subscales; SCL-90-R, Derogatis, 1994), CES-D (Depressive symptoms; Radloff, 1977), Personality Diagnostic Questionnaire (Personality traits according to DSM-IV; PDQ-4, Hyler, 1994), Sheehan Disability Scale (Functional status; SDS, Sheehan, 1983), WHOQOL-Bref (Quality of Life; Trompenaars, et al., 2004), Social Support Inventory (perceived adequacy of social support; SSI, Timmerman et al, 2000) and the secondary gain questionnaire (Van Egmond & Kummeling, 2002). General measures used at Post-test Instruments used at post-test: SCL-90-R, CES-D, SDS, WHOQOL-Bref, GGZ-Thermometer (Patient satisfaction with treatment; Kertzman et al, 2003). The course of the main disorder will be reported with a retrospective life-chart method (Lykestsos et al, 1994). Type, duration and number of treatment interventions will be derived from the medical records. Disorder specific measures used at Pre-test and Post-test Disorder specific data will be gathered at all measurements, depending on the diagnoses according to the MINI made at screening. The following of the disorder specific instruments mentioned in the Multidisciplinary Guideline for Anxiety Disorders (Werkgroep Angststoornissen, 2003), will be used: -Panic Disorder: Panic Disorder Severity Scale (PDSS; Shear, Brown, Barlow, et al, 1997), Mobility Inventory (MI; Chambless, Caputo, Jansin, Gracely & Williams, 1985), Agoraphobic Cognition Questionnaire (ACQ; Chambless, Caputo, Bright & Callagher 1984), Body Sensation Questionnaire (BSQ; Chambless, Caputo, Bright & Callagher, 1984). -Social Phobia: Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987). -Obsessive Compulsive Disorder: Yale-Brown Obsessive Compulsive Scale (Y-BOCS; Goodman, et al., 1989a, 1989b). -Generalised Anxiety Disorder: State-Trait Anxiety Inventory (Zelf-Beoordelingsvragenlijst; Ploeg, et al., 1980; STAI; Spielberger, et al., 1970) -Post Traumatic Stress Disorder: Impact of Events Scale (Schokverwerkingslijst; van der Ploeg, et al., 2004; IES; Horowitz et al., 1979) -Specific Phobia: Fear Questionnaire (FQ; Marks & Matthews, 1979) -Hypochondriasis: Whiteley Index (Pilovsky, 1967). Clinical decision points In order to determine the need for an next step or the termination of treatment, we also want to monitor the effectiveness of the treatment interventions suggested by the guideline. This means every patient will at least be monitored once in every 6, 8, 10, 12, 15, 20, or 30 weeks depending on the treatment intervention suggested by the guideline in the case of the individual patient (see www.ggzrichtlijnen.nl). This monitoring will be part of the clinical decision making in regular treatment and are designated intermediate tests. The instruments used for this limited assessment at essential steps in the guideline (monitoring), are the SCL-90-R and the disorder specific instruments (see above) that correspond to the diagnose of the individual patient. The clinician will also use the Clinical Global Impression of Severity Scale, The Clinical Global Impression of Change Scale and the Clinical Global Impression of Tolerability Scale, which place no burden on the patient because they are filled in by the clinician himself.
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Table. 1. Overview of the measures taken at various moments of time during the study. Measure type General measures
Specific phobia Panic disorder
Social phobia Obsessive Compulsive Disorder General Anxiety Disorder Posttraumatic stress disorder Hypochondriasis
Instrument used for assessment SCL-90-R CES-D PDQ-4 SDS WHOQOL-Bref SSI Secondary Gains Questionnaire CGIS FQ * PDSS * MI * ACQ * BSQ * LSAS * Y-BOCS *
Pre-test
Post-test
x x x x x x x
x x
Follow-up Critical decision points x x
x x
x x
x
x
x
x x
x x x x x
x x x x x
x x x x x
x x x x x
STAI * IES *
x x
x x
x x
x x
Whiteley Index *
x
x
x
x
* the use of these instruments depends on the main diagnosis determined at the initial screening according the MINI. 9.2.7 Necessary time invested by the patient Participation in this study will require the patient to spend 60 minutes filling in questionnaires at pre-test, 50 minutes at post-test and 45 minutes at follow-up, at most. Variation depends on the main diagnosis that was determined at initial screening. The amount of time mentioned above is the time invested by a patient with a panic disorder , for which participation in this study requires investing the most.
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10. Statistical Analysis and power considerations Statistical analysis will include t-tests, multiple logistic regression models and Cox proportional hazard analysis. Risks profiles for remission or treatment-resistance that are of use in clinical practice will be attempted to be deduced from the data. As satisfaction with treatment is measured with the 'GGZ-Thermometer' for some years by the RIAGG Almelo, the results on this variable can be compared to previous years. The number of patients to be included is based on complex considerations. First, the time for therapist to work with the guideline should not be too short to offer an opportunity to work with it in a variety of patients. An inclusion period of 1,5 year and subsequent treatment period of 2 years per individual patient, amounting to a total of 3,5 years experience working with the guideline, is judged to be sufficient. Second, the variety of patients in the project as a whole must be guaranteed and large enough for analysis on subgroups. Third, the power has to be calculated on basis of facts that can not be known exactly (for example the present percentage of adherence to the guideline in the team, the norm that is ideally to be achieved, the level of intracluster variation). So we made a cautious calculation assuming an estimated 60% of adherence to the guideline (for indicators reflecting adequately performed cognitive-behavioural therapy and pharmacotherapy) in the current status. A worthwhile and probably feasible target would be an adherence of 80%. We take into account an extra 20% of patients, which brings the number of included patients to 180, to compensate for intracluster variation and an alpha of 0.05. In this case it is possible to demonstrate a 20% increase of adherence to the guideline with a power of more than 0.95 (Pocock, 1983).
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11. Time schedule Time-schedule of the project: 2004 July - December 2004: Preparation (implementation: analysis of interfering and benificial factors, development and pilot testing of the manual, a first draft will be ready before july 2004) 2005 January - December 2005: Inclusion of patients during 1½ year; pre-tests 2006 January - July 2006: Inclusion and pre-tests; start outtake team July - December 2006: post-tests for a maximum of 2 years, follow-up, outtake team. Report on implementation 2007 January -December 2007: post-tests, follow-up, outtake team; interviews treatment resistant patients 2008 January - July 2008: post-tests, follow-up, outtake team; interviews treatment resistant patients July - December 2008: Data entry, analyses, follow-up 2009 January - July 2009: Analysis, follow-up, data entry Reports on process and effect evaluation July - December 2009: Final analyses. Reports on prediction of treatment resistance, recommendations for the development of care for patients with chronic anxiety disorders and follow-up. 2010 January 2010: Completion
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References Azocar F, Cuffel B, Goldman W (2003) The impact of evidence-based guideline dessemination for the assessment and treatment of major depression in a managed bahavioral health care organization. J Behav Health Serv Res 31;1;109-18 Balkom AJLM van, Dyck R van, Megen van HJGM, Timmerman L, Vliet van IM et al (1998) Richtlijn farmacotherapie angststoornissen. Nederlandse Vereniging voor Psychiatrie. Amsterdam, Boom. Bero L (1998) Closing the gap between research and practice: an overview of systematic reviews of interventions to promote implementation of research findings by health care professionals. BMJ 317;465-8 Borkovec TD, Castonguay LG (1998) What is the scientific meaning of empirically supported therapy? J of Consulting and Clinical Psychology 66;1:136-142 Cabana MD, Rand CS, Powe NR (1999) Why don t physicians follow clinical practice guidelines? JAMA 282;15;1458-65 Casparie AF, Hommes H (1997) Indicatoren voor integrale kwaliteitszorg in ziekenhuizen. Kluwer, Deventer Chambless DL, Caputo GC, Bright P, & Gallagher R (1984) Assessment of fear of fear in agoraphobics: The Body Sensations Questionnaire and the Agoraphobic Cognitions Questionnaire. Journal of Consulting and Clinical Psychology, 52, 1090-1097 Chambless, Caputo, Jasin, Gracely & Williams, The Mobility Inventory for Agoraphobia, Behaviour Research and Therapy, 23, 35-44, 1985 Cohen S, Kamarck T, Mermelstein R (1983) A global measure of perceived stress. J Health Soc Behav 24;385-96 Cowley DS, Ha EH, Roy-Birne PP (1997) Determinants of pharmacologic treatment failure in panic disorder. Journal of Clinical Psychiatry 58; 555-561 Derogatis LR (1994) SCL-90-R, Brief Symptom Inventory, and matching clinical scales, in psychological testing, treatment planning, and outcome assessment. Maruish M (Ed) New York, Erlbaum Dewan NA, Conley D, Svendsen D et al (2003) A quality improvement process for implementing the Texas Algorithm for schizophrenia in Ohio. Psychiatric Services 54:12;1646-9 Drake RE, Goldman HH, Leff HS (2001) Implementing evidence-based practices in routine mental health service settings. Psychiatric Services 52;2;179-82 Gifford DR, Holloway RG, Frankel MR et al (1999) Improving adherence to dementia guidelines through education and opinion leaders. A randomized controlled trial. Ann Intern Med 131;4;237-46 Goldfried MR, Wolfe BE (1998) Toward a more clinically valid approach to therapy research. J. Consulting and Clinical Psychology 66;1:143-150 Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischman RL, Hill CL, Heninger GR & Charney DS (1989a, b) The Yale-Brown Obsessive Compulsive Scale. Archives of General Psychiatry, 46, 10061016 Egmond J van, Kummeling I (2002). A blind spot for secondary gain affecting therapy outcomes. Eur Psychiatry, Vol 17, 46-54. Euroqol Group (1995). EQ-5D User Guide. Rotterdam: Sanders Instituut, EUR Greenberg PE, Sisitsky T, Kessler RC, Finkelstein SN, Berndt ER (1999) The economic burden of anxiety disorders in the 1990s. J Clin Psychiatry 60:7;427-35 Grol R, Grimshaw J (2003) From best evidence to best practice: effective implementation of change in patients care. Lancet 362 (9391);1225-30 Grol R, Wensing (Eds). Implementatie: Effectieve verandering in de patientenzorg. 2001 Elsevier Gezondheidszorg, Maarssen Hoogduin CAL, Verbraak MJPM, Haan E de (1997) Het 'outtake'-team: strategieën ter voorkoming van langdurige behandelingen. In GJ Methorst, CAL Hoogduin, K van der Velden (red.), Richtlijnen bij kortdurende ambulante behandelingen in de ambulante geestelijke gezondheidszorg. Houten/Diegem: Bohn Stafleu Van Loghum. Horowitz M, Wilner N, Alvarez W (1979) Impact of Event Scale: a measure of subjective stress. Psychosom Med 41 (3):209-18. Hutschemakers G, Camp K van der, Hattum M van (2001) Psychotherapie in getallen. Utrecht: Trimbos Instituut. Hyler SE (1994) Personality Diagnostic Questionnaire-4. New York, New York State Psychiatric Institute
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Kertzman T, Kok I, Wijngaarden B van (2003) De GGZ Thermometer nader onderzocht. De evaluatie van een vragenlijst voor cliëntwaardering in de volwassenenzorg. Utrecht: Trimbos-instituut. Lehrer PM & Woolfolk L (1982) Self-report assessment of anxiety: Somatic, cognitive and behavioral modalities. Behavioral Assessment, 4, 167-177 Liebowitz MR (1987) Social Phobia. Mod Probl Pharmacopsychiatry 22: 141-73 Lyketsos CG, Nestadt G, Cwi J, Heithoff K, Eaton WW (1994) The life chart interview: A standardized method to describe the course of psychopathology. Int J Meth Psychiatr Res, Vol 4: 143-155 Marks IM, Mathews AM (1979) Brief standard self-rating for phobic patients. Behaviour Research and Therapy, 17, 59-68 Mellman TA, Miller AL, Weissman EM et al (2001) Evidence-based pharmacologic treatment for people with severe mental illness: A focus on gudelines and algorithms. Psychiatric Services 52;5;619-25 Mendlowicz MV & Stein MB (2000) Quality of life in individuals with anxiety disorders. Am J Psychiatry 157:5;669-82 Neomagus GJH, Terluin B, Aulbers LPJ, Hekman J, Heest FB van et al (1997) NHG-Standaard Angststoornissen. Huisarts en Wetenschap 40;4;167-75 Peters MAJ, Harmsen M, Laurant MGH, Wensing M (2003) Ruimte voor verandering? Knelpunten en mogelijkheden voor verbetering in de patiëntenzorg. Nijmegen: Afdeling Kwalitiet van zorg (WOK), UMC St Radboud Ploeg HM van der,. Defares PB, Spielberger CD. (1980) Handleiding bij de Zelf-Beoordelingsvragenlijst- Een nederlandstalige bewerking van de Spielberger State-Trait Anxiety Inventory. Swets & Zeitlinger, Lisse, The Netherlands Ploeg E van der, Mooren TT, Kleber RJ, van der Velden PG, Brom D. (2004) Construct validation of the Dutch version of the impact of event scale. Psychol Assess 16(1):16-26 Pocock SJ (1983) Clinical trials. John Wiley & Sons, Chichester Prochaska JO, Velicer WF (1997) The transtheoretical model of health behavioral change. Am J. Health Promot 12;38-48 Raad voor Gezondheidsonderzoek (1999) Advies onderzoek geestelijke gezondheidszorg en geestelijke volksgezondheid. Den Haag: RGO, advies nr. 19 Radloff LS (1977) The CES-D Scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 1;385-401 Reich J, Goldenberg I, Vasile R, Goisman R, Keller M (1994) A prospective follow-along study of the course of social phobia. Psychiatry Research 54;249-58 RIVM (2003) Nationaal Kompas Volksgezondheid. www.rivm.nl Roy-Birne PP, Stein MB, Russo J, Mercier E, Thomas R (1999) Panic disorder in the primary care setting: comorbidity, disability, service utilization, and treatment. J Clin Psychiatry 60;7;492-99 Scholing A, Emmelkamp PM (1992) Self report assessment of anxiety: a cross validation of the Lehrer Woolfolk Anxiety Symptom Questionnaire in three populations. Behav Res Ther 30 (5): 521-31 Shear MK, Brown TA, Barlow DH, et al (1997) Multicenter collaborative Panic Disorder Severity Scale. Am. J. Psychiatry 154:1571-1575 Sheehan DV (1983) The anxiety disease. New York, Scribner Sheehan D, Janavs J, Knapp E et al (1994) Mini International Neuropsychiatric Interview. University of South Florida Institute for Research in Psychiatry, Tampa, Florida Spielberger CD, Gorsuch RL, Lushene RE (1970) STAI Manual for the State-trait Anxiety Inventory. Consulting Psychologists Press, Palo Alto, California, Suppes T, Rush AJ, Dennehy EB et al (2003) Texas Medication Algorithm Project, phase 3 (TMAP-3): clinical results for patients with a history of mania. J. Clin Psychiatry 64;4;370-82 Swinson RP, Cox BJ, Woszczuna CB (1992) Use of medical services and treatment for panic disorder with agoraphobia and for social phobia. Can Med Assoc J 147;6;878-83 Tiemeier H, De Vries WJ, Van Het Loo M et al (2002) Guideline adherence rates and interprofessional variation in a vignette study of depression. Qual Saf Health Care 11;3;214-8 Timmerman IGH, Emanuels-Zuurveen ES, Emmelkemp PMG (2000) The social support inventory (SSI): A brief scale to assess perceived adequacy of social support. Clinical Psychology and Psychotherapy 7;401410 Torrey WC, Drake RE, Dixon L (2001) Implementing evidence-based practices for persons with severe mental illnesses. Psychiatr Serv 52;45-50
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Trompenaars FJ, Masthoff ED, Van Heck, GL, Hodiamont PP, & De Vries J. (2004). Content validity, construct validity, and reliability of the WHOQOL-Bref in a population of Dutch adult psychiatric outpatients. Quality of Life Research, in press. Waldorff FB, Almind G, Makela M (2003) Implementation of a clinical dementia guideline. A controlled study on the effect of a multifaceted strategy. Scand J Prim Health Care 21;3;142-7 Weiller E, Bisserbe J-C, Maier W, Lecrubier Y (1998) Prevalence and recognition of anxiety syndromes in five European primary care settings. British Journal of Psychiatry 173(suppl. 34);18-23 Werkgroep Angststoornissen (2003) Multidisciplinaire richtlijn angststoornissen. Richtlijn voor de diagnostiek, behandeling en begeleiding van volwassen cliënten met een angststoornis. Utrecht: TrimbosInstituut/Kwaliteitsinstituut voor de Gezondheidszorg CBO.
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Appendix A ‘Patiënteninformatie’ & ‘Toestemmingsverklaring’
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SIGMA Onderzoek Informatie voor patiënten Waarom deze informatie? In deze brochure willen we u informatie geven over het ‘SIGMA’ onderzoek dat uitgevoerd wordt door de RIAGG Almelo (een onderdeel van Adhesie, instelling voor geestelijke gezondheidszorg Midden-Overijssel) in samenwerking met de Vrije Universiteit in Amsterdam. Het is de bedoeling dat de informatie in deze brochure u kan helpen bij het maken van een keuze of u aan het onderzoek mee wilt doen of niet Onlangs is door diverse experts in Nederland op het gebied van de behandeling van angststoornissen een richtlijn ontwikkeld die aanbevelingen doet over hoe angststoornissen het beste behandeld kunnen worden. Het onderzoek waaraan wij u vragen mee te doen, heeft als doel om na te gaan of mensen die last hebben van angstklachten ook daadwerkelijk beter en sneller herstellen als de behandeling wordt uitgevoerd volgens deze richtlijn. Daarnaast willen we ook kijken hoe tevreden mensen zijn over de zorg die zij ontvangen. Wat houdt een behandeling volgens de richtlijn in? De richtlijn geeft aanbevelingen voor de diagnostiek, behandeling en begeleiding van alle veel voorkomende angststoornissen. Er worden adviezen gegeven over de beste behandeling voor paniekaanvallen (paniekstoornis), diverse fobieen (bijvoorbeeld agorafobie en sociale fobie), specifieke angsten (bijvoorbeeld ziektevrees of hoogtevrees), dwanggedachten- en handelingen (obsessief-compulsieve stoornis) en psychische klachten door traumatische gebeurtenissen (posttraumatische stress-stoornis). Het unieke van deze richtlijn is dat het een gezamenlijk advies is van experts op alle vakgebieden die zich met de behandeling van angststoornissen bezighouden, zoals psychologen, psychiaters, psychotherapeuten, verpleegkundigen en wetenschappelijk onderzoekers. Hierom wordt de richtlijn ook wel de ‘Multidisciplinaire richtlijn angststoornissen’ genoemd. Ook de patiëntenvereniging heeft meegedacht en adviezen gegeven. De aanbevelingen in de richtlijn zijn tot stand gekomen op basis van wetenschappelijk onderzoek of op basis van overeenstemming tussen genoemde deskundigen. Wanneer deze aanbevelingen opgevolgd zouden worden zou dat betekenen dat u de behandeling krijgt, welke tot dusverre het meest effectief gebleken is bij het behandelen van mensen met angstklachten. Waarom een onderzoek? Binnen Adhesie streven we ernaar om de best mogelijke zorg te bieden. Daarom willen we de behandeling van angststoornissen binnen de RIAGG in overeenstemming brengen met de aanbevelingen uit de Multidisciplinaire richtlijn voor Angststoornissen. In sommige specifieke gevallen kan het echter zinvol zijn van deze aanbevelingen af te wijken. Uw behandelaar kan altijd van een advies van de richtlijn afwijken als hij/zij denkt dat dit beter voor u is. Hij/zij zal dit dan met u bespreken. Ook blijft u natuurlijk net als anders zelf beslissen of u een advies uit de richtlijn wilt opvolgen. We hopen met dit onderzoek erachter te komen of de richtlijn de behandelaren helpt om u de beste behandeling te geven die er op dit moment voor uw klachten is. We willen kijken of mensen daardoor sneller en beter van hun klachten herstellen en ook meer tevreden zijn over hun behandeling. Uw deelname aan dit onderzoek is om die redenen dan ook uitermate belangrijk.
Wat gebeurd er als u meedoet aan het onderzoek? Om te kunnen onderzoeken of de richtlijn in de praktijk goed werkt, is het erg belangrijk dat zo veel mogelijk mensen aan het onderzoek deelnemen. We vragen daarom iedereen die voor behandeling van angststoornissen wordt doorverwezen naar het team ‘Angst en Spanningsklachten’ mee te doen.
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Wanneer u besluit mee te doen zal u gevraagd worden voor de start van de behandeling en bij afsluiting van de behandeling een aantal vragenlijsten in te vullen. Wanneer de behandeling langer dan 2 jaar duurt, zult u dan gevraagd worden om de vragenlijsten in te vullen. Het invullen van deze vragenlijsten neemt elke keer ongeveer een uur in beslag. Graag willen we een jaar na het afsluiten van de behandeling weten hoe het met u gaat om te weten of de behaalde resultaten ook op langere termijn aanwezig blijven. Indien u hiervoor toestemming geeft, willen wij u een jaar na het afsluiten van de behandeling nog eens benaderen met de vraag of u dezelfde vragenlijsten nogmaals wilt invullen. Wij verwachten niet dat deelname aan het onderzoek risico’s voor uw lichamelijke of psychische gezondheid met zich meebrengt. U zult dezelfde hulp krijgen als mensen die besluiten af te zien van deelname aan het onderzoek. Deelname aan het onderzoek betekent alleen dat u 3 keer 1 uur kwijt bent met het invullen van vragenlijsten. Gemiddeld genomen zal dit beteken dat u per jaar 1 uur van uw tijd gevraagd wordt voor deelname aan dit onderzoek.
Voordelen van deelname aan het onderzoek Als u deelneemt aan het onderzoek kunt u daar wellicht andere patiënten in de toekomst mee helpen. Als middels dit onderzoek aantoonbaar kan worden gemaakt dat het werken volgens de Multidisciplinaire richtlijn voor Angststoornissen maakt dat mensen sneller en beter herstellen, dan zal dat het gebruik van de richtlijn bevorderen. Daarnaast hopen we, door beter te weten welke zorg het beste is voor welke mensen, steeds meer ‘maatwerk’ te kunnen bieden en daardoor mensen sneller van hun klachten af te helpen. Tegelijkertijd zal door deelname aan dit onderzoek uw eigen voortgang in de behandeling preciezer gevolgd kunnen worden. Dat zal er toe leiden dat op tijd, en mogelijk ook wel sneller dan normaal, eventueel volgende stappen in uw behandeling genomen zullen worden. Wij verwachten dat door deelname aan dit onderzoek uw behandeling zo kort als mogelijk en zeker niet langer dan nodig zal zijn. Vertrouwelijkheid van de gegevens De gegevens over u en uw klachten die we ten behoeve van uw behandeling en het onderzoek zullen verzamelen, zullen door het onderzoeksteam vertrouwelijk worden behandeld. Behalve leden van het onderzoeksteam en uw behandelaar heeft niemand, zonder uw schriftelijke toestemming, inzage in uw gegevens. De verwerking van uw gegevens gebeurt anoniem. Uw naam zal in geen enkel verslag of rapport worden genoemd of af te leiden zijn. Tien jaar na afronding van het onderzoek zullen de gegevens worden vernietigd. Wat gebeurt er als u niet deelneemt? Als u besluit niet mee te doen aan het onderzoek, heeft dat voor u natuurlijk geen enkel negatief gevolg. U wordt dan gewoon behandeld zoals anders ook zou gebeuren. Vragen Wenst u meer informatie, dan kunt u contact opnemen met de coördinator van deze studie: Maarten van Dijk, psycholoog Stichting Adhesie Sector gespecialiseerde GGZ Almelo RIAGG Almelo Hanzelaan 1 7607 NL Almelo tel:0546542424
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Mocht u voor het maken van een keuze of u mee wilt doen aan het onderzoek behoefte hebben om met een psychiater te overleggen die niet bij het onderzoek betrokken is, dan kunt u contact opnemen met: Dhr. B van Wel, psychiater Stichting Adhesie, locatie Westeres MFE Resocialisatie Boddenstraat 12 7607 BM Almelo Tel: 0546 - 54 75 00
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SIGMA ONDERZOEK
TOESTEMMINGSVERKLARING
Ondergetekende wil deelnemen aan het SIGMA onderzoek. Het doel en de gang van zaken van dit onderzoek zijn mij mondeling uitgelegd, tevens heb ik ook schriftelijk informatie ontvangen en hier kennis van genomen. Het is mij duidelijk dat deelname aan het onderzoek geheel vrijwillig is en zonder verplichtingen. Het staat mij en aller tijde vrij mijn deelname aan dit onderzoek op te zeggen. Ik ga wel / niet * akkoord dat men mij een jaar na het afsluiten van de behandeling benaderd om te kijken te kijken hoe het beloop is van mijn klachten.
Ik ga wel / niet * akkoord dat men informatie bij mijn huisarts opvraagt over de medische zorg die ik ontvangen heb.
Ik ga wel / niet * akkoord dat men informatie bij mijn zorgverzekeraar opvraagt over de medische zorg die ik ontvangen heb.
* omcirkelen wat van toepassing is
In blokletters invullen a.u.b.: Naam:…………………………………………….. Geboortedatum:…………………………………. Handtekening:……………………………………. Datum:……………….., plaats:………………….
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