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Development and usability test of an electronic documentation system for pain therapy

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1 Ulm University Hospital Clinic for Anaesthesiology Medical Director: Prof. Dr. med. Dr. med. H. c. Michael Georgieff Development and usability test of an electronic documentation system for pain therapy Dissertation for obtaining the doctoral degree in human biology at the Medical Faculty of the University of Ulm, presented by Heiner Ulrich Molzen from Würzburg 2007

2 Acting Dean: Prof. Dr. Klaus-Michael Debatin 1st Rapporteur: PD Dr. Peter Steffen 2nd reporter: Prof. Dr. Walter Bongartz PhD Day: January 25, 2008

3 dedicated with gratitude to my wife Birgit and our daughter Franka Joy

4 Table of Contents 1.

5 3.3. Summary of the results Discussion Discussion of content Methodological discussion Development perspective and outlook Summary Bibliography Appendix User survey Key table Treatment types Reports Master data sheet Progress report Annual statistics Operator statistics Automated documents Doctor's letter Patient letter ErgoNorm questionnaire Evaluation of the ErgoNorm questionnaire Image material used CD-ROM Acknowledgment 157 II

6 List of Abbreviations ADS General Depression Scale ANSI American National Standards Institute ASCII American Standard Code for Information Interchange AU Incapacity for work BAuA Federal Institute for Occupational Safety and Health BMI Body Mass Index BPI Brief Pain Inventory CD-ROM Compact Disk Read-Only Memory CRPS Complex Regional Pain Syndrome CRSS Coping reactions in painful situations (part of the KSI) DGS German Society for Pain Therapy e. V. DGSS German Society for the Study of Pain e. V. DIN German Institute for Standardization DRG Diagnosis Related Groups DSF German Pain Questionnaire DSM Diagnostic and Statistical Manual of Mental Disorders EDV Electronic Data Processing EN European Standard ERSS Emotional Reactions in Pain Situations (Part of the KSI) FW7 Questionnaire on habitual well-being GCPS Graded Chronic Pain Status GdB degree the handicap HADS Hospital Anxiety and Depression Scale HADS-A Anxiety Score of the HADS HADS-D Hospital Anxiety and Depression Scale, German version; Here also the depression score of the HADS IASP International Association for the Study of Pain ICD International Classification of Diseases ID identification number IEEE Institute of Electrical and Electronic Engineers IHS International Headache Society ISH med Hospital Information System III

7V. TENS Transcutaneous electrical nerve stimulation UDO Ulm documentation system for pain patients VAS Visual Analog Scale VBA Visual Basic for Applications VRS Verbal Rating Scale WHO World Health Organization IV

8 1. Introduction 1.1. Preliminary remark One of the most important foundations of scientific work is to describe one's own approach precisely and comprehensibly and to record the observed effects on the examined object in detail. This also applies to the areas of medical research and therapy, some of which are empirically based. The maxim of documenting therapeutic action as well as resulting changes as precisely as possible becomes more important, the less the object of investigation can be described with precisely determinable parameters. Pain as a subjective and interindividually extremely heterogeneously perceived, experienced and mentally and emotionally processed phenomenon represents such a research content that is difficult to grasp precisely. Therefore, in pain therapy and pain research in particular, it is of the greatest importance to combine findings, therapeutic measures and treatment results over time to be able to record and display a high degree of resolution. The claim to conduct well-founded and scientifically exact research work and to establish a high-quality standard of therapy, however, is increasingly opposed to unfavorable framework conditions. As a result of the health policy regulatory measures of the last decades and the subsequent counter-reactions in the health care system, doctors and other therapeutic professional groups are not only exposed to increasing time and performance pressure, but are also increasingly concerned with non-medical, billing-related tasks. In this area of ​​tension between scientific-therapeutic demands and economic demands, electronic data processing systems play a central but not unproblematic role. On the one hand, they often make work easier by systematically recording, evaluating and distributing patient-related information. On the other hand, the commercial database systems are always used to record the services and to prepare the treatment data for accounting purposes, whereby additional, originally commercial tasks are passed on to the doctor or psychologist providing the service. Primarily non-commercial, scientifically oriented medical data processing systems such as those used in pain therapy, on the other hand, harbor the risk that research interests 1

9 or following high quality standards, to query too detailed data and in this way to further increase the burden of documentation on the therapeutic workers. On the basis of these considerations, a database application was developed in the pain therapy section of the Clinic for Anaesthesiology at the University Hospital Ulm, which is designed according to ergonomic aspects and with the help of which a patient-related data set reduced to the core data relevant to pain therapy can be recorded and further processed today viewed as a complex bio-psycho-social overall event (Figure 1). The neurophysiological processes of nociception at the receptor level, the transmission of pain signals from the periphery, their switching and filtering in the dorsal horn of the spinal cord, the further processing and emotional-affective coloring of the impulses at the subcortical level and finally the awareness of the pain in the cortex, the activation of associated ones Memory content and the cognitive interpretation and evaluation of the pain stimulus experienced are considered to be dependent on genetic, immunological and metabolic factors on the one hand and cognitive, affective and behavioral factors as well as the interactions of the individual with the social environment on the other. BIOLOGICAL FACTORS PSYCHOLOGICAL FACTORS SOCIAL FACTORS PAIN Figure 1: Bio-psycho-social pain model according to BIRBAUMER (Birbaumer 1986) 2

10 Every diagnostic or therapeutic approach to the pain process must therefore take into account the complexity of these processes and include the widest possible range of pain recording. In the past decades numerous efforts have been made to measure and describe pain in ever more differentiated ways or is described in terms of such damage (Donner et al. 2001, p. 109). For pain measurement, this results in the difficulty of having to capture and quantify a subjective quality of feeling and experience. In the experimental pain measurement, dosed pain stimuli are applied under laboratory conditions and certain threshold values ​​are determined (pain threshold, pain tolerance). Thermal (heat, cold), electrical (current), mechanical (e.g. pressure) or chemical stimuli (e.g. hypoxia) are used. If the test person is included in the assessment of the pain stimuli or the determination of the threshold values, one speaks of subjective algesimetry. The objective algesimetric methods include micro-neurography (derivation of the activity of nociceptive fibers), reflex measurement (e.g. withdrawal reflex) and the derivation of somatic evoked potentials (SEP) for pain stimuli of different intensity. It is not necessary for the test person to assess the stimulus intensity. The experimental approaches to pain measurement have the disadvantage that both the reasonable pain intensity and the pain duration are limited for ethical reasons. In contrast to the pain patient, the test person can be sure that the pain stimulus is only temporary and will not last. Therefore, the experimental pain measurement is only an inadequate model of clinical, acute or chronic pain. The clinical pain measurement is defined as the subjective pain assessment by the patient, in which pain perception and pain experience are described (Donner et al. 2001, p. 112). In the meantime, numerous instruments are available for self-assessment of clinical pain, which enable a differentiated description of the pain process, for example with regard to localization, intensity, sensory and affective quality or the disability experienced by pain. This is 3

11 rating scales and questionnaire procedures, some of which are repeatedly presented to the patient over the course of the year, in order to assess the effect of the therapy on the pain symptom. An apparatus-based pain measurement is not common in everyday clinical practice. The standardized measurement of pain sensitivity in patients with a generalized, somatoform pain disorder (ICD-10 F45.4) or fibromyalgia (ICD-10 M79.70) is an exception ), a defined pressure is applied selectively and the patient's pain reaction is observed or the pain and tolerance thresholds are measured. If the patient shows a clear pain reaction (e.g. pulling away, uttering a voice) at at least 11 of these measuring points, the criterion is fulfilled and if other positive indicators are present (e.g. accompanying vegetative symptoms) the diagnosis of fibromyalgia is made (Wolfe et al. 1990). Pressure is applied to the tender points either with the index finger, with a mechanical pressure algesimeter or PC-controlled (Nebel et al. 2004) Rating scales Rating scales are used in both experimental and clinical pain measurement, on the basis of which patients can measure To assess the intensity of the pain felt. These are economical, easily understandable, valid and change-sensitive measuring instruments. With the visual analog scale (VAS), only the endpoints are conceptually designated with no pain at the beginning and the strongest imaginable pain at the end of the scale. The patient is asked to mark the pain level currently experienced on the scale between the two extremes with a pen. The distance between the starting point no pain and the patient's marking in millimeters gives the measure of the current pain intensity. In addition to the paper form, the visual analogue scale is also available as a slider (pain ruler) that the patient can set to his current pain level. The examiner then reads the pain intensity (in millimeters) on the back of the controller. With the Verbal Rating Scale (VRS), the pain intensity is indicated on a multi-level, so-called Likert scale (equally spaced scale), in which the number of levels and the level designations (e.g. not moderate very strong) can vary depending on the author . In the Numerical Rating Scale (NRS), an 11-point Likert scale has established itself, on which 0 = no pain 4 between the endpoints

12 and 10 = strongest imaginable pain the current pain intensity is indicated. Both the VRS and the NRS are presented either as a paper-and-pencil procedure or the patient is asked to verbally read off his or her pain intensity from the scale presented. The latter is used, for example, for perioperative pain measurement, whereby a combination of VRS and NRS is also used (Steffen 2005, p. 13) Pain diaries Pain diaries offer the possibility of observing pain over time. The patients are asked to indicate their current pain intensity on a rating scale (VAS, VRS or NRS) at fixed time intervals or whenever pain occurs. This results in daily, weekly and monthly profiles that are helpful for pain diagnosis and the assessment of therapeutic effects. In addition to the frequency and intensity of pain, accompanying symptoms such as B. nausea or morning stiffness of the joints is queried or the activities of the day, the sleep quality of the previous night, the current mood, the pain-related impairment experienced or the type and amount of medication taken are recorded. The Heidelberg pain diary (Seemann et al. 1987), the Ulm pain diary (Hrabal et al. 1991, S) and the Kiel headache calendar (Göbel 2004, p. 31) have established themselves particularly well in Germany the measurement of pain: Pain cannot yet be measured with any single scale. Electrophysiological, biochemical, neurophysiological as well as psychophysiological measurement methods have so far not been able to record pain satisfactorily. (Pioch 2005, p. 49) This results in the need, on the one hand, to develop differentiated individual instruments for recording different aspects of pain and, on the other hand, to combine these individual instruments into larger diagnostic units in order to obtain the most differentiated picture of the whole when viewed as a whole To receive painful events of a patient. In recent years, numerous diagnostic instruments and inventories have been developed to record various aspects of pain experience, pain processing and pain behavior. The McGill Pain Questionnaire (MPQ), the Kiel Pain Inventory (KSI) and the German Pain Questionnaire (DSF) are presented here as examples. 5

13 McGill Pain Questionnaire The McGill Pain Questionnaire by MELZACK (Melzack 1975) represents pioneering work in the field of standardized pain recording. It was created in the 1970s and aimed at not only analyzing intensity but also other aspects of the patient's subjective experience of pain to record, quantify them and make them statistically usable. MELZACK recommends reading the questionnaire instructions to the patient and being present during further processing in order to be able to answer any questions that may arise and to ensure that the questions are processed correctly. The first part of the questionnaire (Where is your pain?) Asks about the location of the pain. The patient should mark in an anatomical drawing of the human body where he feels pain everywhere (Figure 2). Figure 2: Pain drawing from the McGill Pain Questionnaire by MELZACK (1975) In the second section (What does your pain feel like?), Adjectives are given to describe pain, which are grouped into groups of two to six words each. The adjectives and the groups formed come from a preliminary study in which they were also assigned scores that indicate the severity of pain associated with the respective adjective (Melzack and Torgerson 1971). According to the author, the patient is able to use the adjectives to relate his pain to 6

14 to describe sensory (e.g. jumping, flashing, shooting), affective (e.g. punishing, grueling, cruel, vicious, killing) and evaluative aspects (e.g. annoying, troublesome, miserable, intense, unbearable) . The patient should circle the word that applies most to the group of words that correspond to his or her pain. Several characteristic values ​​can be calculated from the selected attribute words (e.g. number of selected words, sum of the intensity scores of the selected words). The third section (How does your pain change with time?) Deals with the change in pain over time. The patient should state the temporal pattern with which his pain occurs and what alleviates or intensifies it. The last subscale of the McGill Pain Questionnaire uses a five-point verbal rating scale (Mild Discomforting Distressing Horrible Excruciating) differentiated according to the current, maximum, minimum and relative pain intensity (e.g. Which word describes your pain right now? Or Which word describes the worst toothache you ever had?). MELZACK certifies that its instrument has good sensitivity in differentiating the effectiveness of different therapy methods (biofeedback, hypnosis, biofeedback and hypnosis combined) for different types of pain (menstrual cramps, arthritis, tumor-related pain, toothache, back pain, phantom pain, post-herpetic pain). In addition, the MPQ is able to determine the relative effects of different intervention methods on the sensory, affective and evaluative aspects of pain (Melzack 1975, p. 294) Kieler pain inventory (KSI) The Kieler pain inventory (KSI) by HASENBRING is a psychometric method for the comprehensive description of the emotional, cognitive and behavioral aspects of pain. The theoretical basis of the instruments is, on the one hand, the coping research by LAZARUS (Lazarus and Launier 1981) and, on the other hand, learning-theoretical concepts of classical and operant conditioning This includes reactions that follow the perception of pain and that can be described on an emotional, cognitive and behavioral level (Hasenbring 1994, p. 2).The KSI enables a patient's pain coping and processing processes to be described on the three levels mentioned and therefore consists of three largely independent parts: Emotional 7

15 Reactions in Painful Situations (ERSS), Cognitive Reactions in Painful Situations (KRSS) and Coping Reactions in Painful Situations (CRSS). The period of time that patients should refer to when answering the questions is the last 14 days. Each individual question must be assessed using a seven-point Likert scale. The ERSS questionnaire consists of 15 items, which are assigned to the subscales anxiety / depression (8 items), irritable mood (3 items) and elated mood (4 items). Example item ERSS: If I felt my pain in the past 14 days, I never felt 1. downcast every time The questionnaire cognitive reactions in painful situations (KRSS) comprises 34 items, divided into the scales helplessness / hopelessness (9 items), Disability (6 items), catastrophizing (5 items), perseverance appeals (4 items), coping signal (4 items), trivializing (4 items) and psychological causal attribution (2 items). Example item KRSS: When I register my pain, this thought occurs to me 1. What can be behind it? never every time The questionnaire Coping Reactions in Painful Situations (CRSS) consists of 63 items that factor-analyze the eight subscales avoidance of social activities (9 items), requests for social support (12 items), avoidance of physical activities (10 items), non-verbal / motor Expression (7 items), relaxation-promoting distraction (6 items), perseverance strategies (11 items), passive measures (5 items) and active measures (3 items) could be assigned. The frequency of occurrence of the individual coping strategies should be assessed twice, once for mild and once for severe pain. Example item CRSS: When I am in pain This is how I act / think in the case of mild / severe pain 1. I never interrupt strenuous activities every time 8

16 The Kiel Pain Inventory is designed for adults. It can be carried out both in an individual test and in a group. In addition to the paper-and-pencil version, there is also a computer version. The evaluation is carried out by calculating the arithmetic mean of the subscale values ​​for each of the three questionnaires separately. The results are recorded in an evaluation sheet, which allows the creation of profiles. The particular value of the KSI for pain psychotherapeutic practice lies, in addition to the comprehensive presentation of the patient's pain coping behavior, above all in the fact that the individual answers give rise to concrete points of contact for the therapy psychological pain aspects has a long history. The first concepts based on the American model were developed as early as the 1970s. The first complete version of the DSF was created between 1993 and 1997 and evaluated on a large group of patients (Nagel et al. 2002). An outline of the development history of the questionnaire can be found in PFINGSTEN (Pfingsten et al. 2006, p. 3). In 2005, the two large German professional associations, DGSS (German Society for the Study of Pain) and DGS (German Society for Pain Therapy, formerly Schmerztherapeutisches Kolloquium e.v.), decided to standardize their pain documentation instruments and commissioned a joint commission with this. A multi-center evaluation study examined the preliminary version of the new, joint pain questionnaire with regard to test quality criteria and practicability. This resulted in various recommendations for changes (Pfingsten et al. 2006, S), on the basis of which the final version of the new German pain questionnaire of both professional societies (DGSS and DGS 2007; Pfingsten et al. 2007) was created. The DSF is a 15-page self-assessment tool made up of 25 questions (individual questions or subscales with additional items) and five modules (one page each with additional questions). The contents of the questions and modules are shown in the table below. 9

17 Table 1: Structure and content of the German Pain Questionnaire (DSF) Version 2007 Question Content Description Date of birth, age; Gender; Height; Body weight 5. Pain location and description of pain Pain drawing; Description of the pain in your own words 6. Main pain (reason for treatment) 7. Duration of pain Duration of pain; if applicable, date of onset of pain 8. Temporal aspects of pain occurrence pattern; If necessary, frequency and duration of the attacks 9. Circadian rhythm Pain intensity over the course of the day 10. Pain description list affective and sensory pain description (SBL) 11. Pain intensity Pain intensity current and in the past 4 weeks 12. Pain-related impairment Number of impaired days and severity of functional impairment in different areas in the past 3 months 13. Cause of pain Causal attribution of the patient Question about insurance status 14. Pain control strategies Activities of the patient to influence pain or external control belief 15. Pain modulation Subjective pain triggers and pain intensifiers 16. General well-being Subjective feeling of the past 14 days (FW7) 17. Hospital Anxiety and Depressivity and Anxiety Depression Scale (HADS-D) 18. Suicidality Suicidal thoughts 19. Pre-treatment practitioner Pre-treatment disciplines and, if necessary, pain diagnoses 20. Pre-treatments Ar t and success of previous therapeutic measures 21. Operations pain-related and non-pain-related surgical interventions 22. Current type of medication and dosage of current medication Use 23. Medication use earlier Previous medication, effectiveness and side effects 24. Medication allergies, known intolerances 25. Comorbidity Further illnesses and consequences of illness; Risk factors; Incompatibilities Module D Demography, Insurance Personal data; referring doctor, other doctors and psychotherapists; Health and other insurance; Housing situation; School education Module L Health-related questionnaire SF-12 (4 weeks) Quality of life Module S Social law situation Occupation, ability to work, pension receipt or pension application, recognized disability Module V Pretreatments Pain-related outpatient and inpatient pretreatments and rehabilitation stays; Release from the duty of confidentiality for pretreatment practitioners Module A General well-being (QLIP) General well-being; Sleep duration; Pain and pain-related impairment; Success of personal alleviation efforts; other complaints 10

18 A large number of the questions are used to collect pain-related data. In addition to indicating the localization of their pain by means of a pain drawing and a description of the pain in their own words, the patients are asked to weight and indicate what their main pain is. Temporal aspects of the occurrence of pain (pain pattern, pain duration, circadian rhythm) are also queried in detail. With regard to pain intensity, an 11-point, numerical rating scale (section) is used to ask about the current pain intensity when completing the questionnaire and secondly about the average and the greatest pain intensity in the past four weeks. In addition, the patient should assess which pain intensity would be bearable for him if the therapy was successful (expectation of success). Further questions deal with the pain-related impairment of the patient. For the areas of everyday life, leisure and work, the impairment experienced by pain is also to be assessed using 11-point, numerical rating scales. In addition, the number of days on which the pain prevented the patient from normal activity in the last three months must be stated. The reference framework for the impairment assessments is the past three months. Both the information on pain intensity and the data on pain-related impairment are included in the formation of the severity index according to VON KORFF (section). The answers to questions about the presumed causes of pain, the strategies used to influence pain and individual pain triggers and intensifiers provide important information on the patient's individual pathogenesis and healing ideas (health belief model), as well as his control beliefs. Another set of questions and a separate module (Module V) deal with medical-somatic anamnesis data, such as previous illnesses and risk factors, previous treatments, operations, hospital or rehab stays and the medication history (SES) is a list of 24 adjectives that is used to measure subjective pain perception (Geissner et al. 1992; Geissner 1995). Based on the patient's consent to the individual items (4-point scales), the affective and sensory pain perception score can be calculated. Investigations on the SES had shown, however, that the list was clearly 11 without any significant loss of information

19 can be shortened (Korb and Pfingsten 2003). The new German pain questionnaire therefore contains a so-called pain description list (SBL) that has been shortened to 12 items instead of the SES. The SBL contains four items (adjectives) to describe the affective and eight items for the sensory pain perception. The patient agrees to the items on a four-point scale from 1 = does not apply to 4 = applies exactly. According to the author, the evaluation is only carried out for the affective pain descriptions by adding the individual scores (value range 0-12). Eight points are given as the cutoff value from which a conspicuous affective description of pain can be attested. The sensory pain information is used for differential clinical pain diagnostics (Korb 2007) Psychological well-being (FW7) With the seven-item questionnaire on habitual well-being (FW7) (Herda et al. 1998), the German pain questionnaire contains a new instrument that was previously not included. The so-called habitual well-being, which the scale measures, is defined as a trait, i.e. as a relatively persistent personality trait that can be seen in contrast to the rapidly fluctuating, momentary state of mind. According to the authors, well-being is an important component of therapeutic success. Example item FW7: Despite the pain, I would say 4. I was able to enjoy my life fully disagree fully agree The agreement with the items formulated as statements on the positive well-being area is expressed on a six-point Likert scale. The evaluation takes place by forming a simple total score (max. 42 points) or average value (max. 6 points) of the given answers. A cut-off value is not given. However, there are numerous comparative values ​​from different clinical and non-clinical samples. The authors certify that the method has excellent test quality, especially high reliability and good sensitivity to change. Hospital Anxiety and Depression Scale (HADS-D) The previous version of the pain questionnaire still contained the General Depression Scale (ADS) (Hautzinger and Bailer 1993) Questionnaire comprising 20 items 12

20 to record depressive symptoms. In addition to the scope, the confusion of depression-related symptoms with pain-related symptoms (e.g. sleep disorders) that occurred in pain patients was a problem that ultimately led to ADD no longer being included in the new version of the German pain questionnaire (Korb and Pfingsten 2003 ). An instrument for recording anxiety symptoms was not previously included in the German pain questionnaire. However, fear or anxiety is a variable in pain patients that plays an important role, for example, in the chronicity of pain. After Pentecost, fear of pain gives rise to a high level of motivation to generally avoid potentially painful activities, which has a guiding effect on (back) pain-specific assumptions (fear-avoidance beliefs) (Pfingsten et al. 1997). The Hospital Anxiety and Depression Scale (HADS) was developed to record depressive and anxiety-related symptoms, especially in patients with somatic diseases, the German version of which is replacing ADS in the new pain questionnaire. The German version of the HADS, the HADS-D (Herrmann et al. 1995) has been included in the DSF completely and only slightly modified compared to the original publication. The 14 items are to be answered in four different levels (values ​​0 to 3), whereby the answer levels are designated differently depending on the question context. Some items are weighted the other way around in the sense of the question: If, for example, the question about depression, I can still be as happy today as it used to be, is just as strongly supported, this results in the lowest score with regard to depression (0). Figure 3: Hospital Anxiety and Depression Scale (HADS-D) in the German Pain Questionnaire: Example items for anxiety (A) and depression (D) with corresponding point values ​​for evaluation 13

21 The HADS-D is evaluated by forming two simple total scores for the seven anxiety (A) and the seven depression (D) items (value range from 0 to 21). A maximum of one missing value per subscale can be estimated by taking the mean of the other items on the same scale. Total scores between eight and ten are seen as borderline and indicate the presence of symptoms of anxiety or depression (suspected diagnosis). From a total score greater than or equal to 11, according to the authors, clinically relevant anxiety or depression symptoms can be assumed. Health-related quality of life (SF-12) A quality of life scale was already included in the first version of the pain questionnaire (DGSS 1997). The SF-36 questionnaire on health status (Bullinger and Kirchberger 1998), the German version of the Medical Outcome Study 36-item Short-Form Health Survey (Ware and Sherbourne 1992), is an internationally recognized and widely used (40 languages), Well-validated and comprehensively standardized measuring instrument for recording health-related quality of life, which can be used both on healthy people and on patient populations regardless of somatic or psychiatric diagnoses. The subjective health is measured, regardless of the actual state of health. For economic reasons, the SF-36 in the new German pain questionnaire was replaced by a corresponding short form, the SF-12 (Korb and Pfingsten 2003). The SF-12 comprises only 12 items and forms the L module of the new DSF. As with the SF-36, the evaluation is comparatively complicated and requires the use of coefficients from the North American norm sample. The result is expressed in a physical and a psychological total score, with higher values ​​indicating a better subjective state of health (without cut-off information) Chronification stage and severity assessment For a systematic pain diagnosis and treatment indication, in addition to a differentiated description of the various aspects of the pain process, a graduation is also required and severity assessment necessary. For this purpose, GERBERSHAGEN developed the concept of the chronification stages of pain (Gerbershagen 1986). He assumes that pain diseases continuously become chronic and go through various stages of development one after the other until they finally reach a maximum degree of chronicity. Chronic pain patients should then be examined, 14

22 what stage of chronification they are in. VON KORFF, on the other hand, conceives its severity assessment more as a damage assessment without postulating a chronological sequence or an end stage (Klasen et al. 2004; von Korff et al. 1992). Both the severity assessment according to VON KORFF (Graded Chronic Pain Status, GCPS) and the chronification stage according to GERBERSHAGEN (Mainz Pain Staging System, MPSS) can be determined from the patient information in the new German pain questionnaire. For the MPSS score, however, a detailed medical history is also required (Pfingsten et al. 2006, p. 8). PIOCH impressively demonstrates that both systematizations are justified by several case studies, which show that patients can achieve a low grading in one system and a high grading in the other (Pioch 2005, p. 31) Graded Chronic Pain Status (GCPS ) The graduation instrument according to VON KORFF can be carried out in interview form as well as in questionnaire form. Using six 11-point Likert scales, the patient should assess their pain (current pain severity; maximum and average pain severity) and pain-related impairment (everyday activities, leisure activities, ability to work) (each from 0 = no pain / no impairment to 10 = most severe imaginable pain / no more activity possible). Another question relates to the number of days on which the patient was unable to pursue his usual activities due to pain in the last three (in the DSF) or six months (in the original publication). The evaluation is carried out by calculating and evaluating three parameters (Pioch 2005, S; von Korff et al. 1992): The characteristic pain intensity is calculated by adding up and averaging the information on the current, maximum and average pain intensity. By multiplying it by 10, the result is transformed in such a way that a value range from 0 to 100 results. The second parameter is the impairment score. It is calculated analogously from the specified impairment in the areas of everyday life, leisure and work and also transformed.Using a special algorithm, the sum of the impairment value and the number of impairment days results in the third value, the impairment points (Table 2). 15th

23 Table 2: Impairment points according to VON KORFF for the assessment period 3 months Impairment days Impairment value (0-100) 0-3 days 0 points Points 4-8 days 1 point Point 9-15 days 2 points Points 16 days 3 points 70 3 points From the three parameters obtained in this way, characteristic pain intensity (between 0 and 100), impairment value (between 0 and 100) and impairment points (between 0 and 6), the severity of the chronic pain disorder is determined according to a fixed scheme (Table 3). Table 3: Evaluation of the severity of chronic pain disorders according to VON KORFF Result of the parameter calculation Severity Interpretation Pain intensity = 0 no pain problem grade 0 no pain problem in the observation period Pain intensity <50 and impairment points <3 Grade I low impairment and low pain intensity Pain intensity> 50 and impairment points <3 Grade II low impairment and high pain intensity 3-4 impairment points, regardless of the pain intensity grade III medium impairment, which has a moderate effect 5-6 impairment points, regardless of the pain intensity grade IV high impairment, which has massive effects In several studies, the GCPS proved to be valid and reliable instrument for determining the severity of chronic pain conditions (Klasen et al. 2004) Mainz Pain Staging System (MPSS) The Mainz stage model of pain chronification (Gerbershagen 1986) is located both as a third-party assessment tool and in a self-assessment version. The overall score includes pain and anamnesis data, which are assigned to the four axes of time aspects (3 items), spatial aspects (1 item), drug intake behavior (2 items) and patient careers (4 items). Both pain-related (e.g. frequency of occurrence) and behavior-related factors (e.g. change of personal doctor) are taken into account. The evaluation is carried out by forming axis sums from the values ​​of the individual items. The so-called axis stages are calculated from the axis sums using a coding key that is noted on the evaluation sheet. The total chronification stage results from the sum of the axis stages according to a further coding scheme (Figure 4). 16

24 Figure 4: Evaluation sheet of the Mainz Pain Staging System (MPSS) The MPSS is widespread in Germany and has proven itself in numerous studies as a useful and reliable instrument (Pfingsten et al. 2000), with which it is also possible to predict the success of the therapy. The MPSS is criticized, among other things, because it neglects the psychosocial dimension of pain chronification and because individual items in follow-up examinations cannot depict any improvements (concerns the number of withdrawal treatments and all items in axis 4: patient careers) (Pioch 2005, p. 42). 17th

25 Pain classification As a result of the diagnostic process, at the beginning of a pain therapy, the physical and psychological examination of the patient, the anamnesis and the differentiated and comprehensive recording of the bio-psycho-social aspects of the individual pain occurrence with the help of suitable questionnaire procedures and the resulting severity and determination of chronicity provide a wealth of information. It is now necessary to integrate this wealth of data into a hypothetical conditional model of the pain disorder and to derive a diagnostic categorization from this, which enables a differentiated treatment indication as possible. The conventional classification systems for diagnosing somatic diseases (ICD-10) and psychiatric disorders (DSM-IV; ICD-10 Chapter F) are, however, not very suitable for diagnosing pain. On the one hand, a dichotomous somatic-psychological understanding of illness is assumed, which does not permit multi-dimensional descriptions of the syndrome; on the other hand, the diagnoses relevant to pain are distributed over the entire classification system and are not assigned to a separate chapter (Klinger et al. 1997). Therefore, own pain diagnostic taxonomies were developed, which take into account the desired multidimensionality and differentiation. The classification of the International Association for the Study of Pain (IASP) (Merskey and Bogduk 1994) consists of two parts. In the first part, 320 pain syndromes are described in detail. The second part represents a coding system with the help of which pain disorders in the five dimensions (1) body region / pain topic, (2) system primarily affected by pain, (3) time characteristic of pain, (4) pain intensity and duration and (5) Etiology of pain can be categorized. The IASP classification has so far not been able to establish itself in the German-speaking area, mainly due to the lack of a simultaneous coding option for pain-related psychosocial factors (Pioch 2005, p. 17). A very differentiated and comprehensive diagnosis and classification system of the International Headache Society (IHS) is available for the classification of headaches (Headache classification committee of the International Headache Society 1988). The IHS taxonomy consists of 13 categories and allows the parallel coding of duration, chronification and the psychosocial factors involved. There is a comprehensive pain classification system for the German-speaking area that does not have the above-mentioned deficiencies and applies to all types of pain

The following can be detected: The multiaxial pain classification MASK is divided into the two dimensions MASK-S (somatic dimension (Maier and Hildebrandt 1990)) and MASK-P (psychosocial dimension (Klinger et al. 1997)). The somatic dimension of the MASK is divided into two parts. On the one hand, it consists of a catalog of phenomenological-descriptive diagnoses that are organized according to pragmatic aspects and assigned to nine pain groups. A further differentiation on up to five additional levels is possible below the respective group. Up to six-digit codes can be used as diagnoses (Table 4). Table 4: Hierarchical structure of the MASK-S with coding example back pain MASK pain groups 1 Headache 2 Facial pain 3 Pain in vascular diseases 4 Neuropathic pain 5 Back pain 53 Local lumbo-sacral back pain 535 after surgery 5351 after open disc surgery and instability postoperatively changed qualitatively or quantitatively 6 Pain of the musculoskeletal system 7 Visceral pain 8 Acute perioperative and post-traumatic pain 9 Pain without clinical or anamnestic evidence of a somatic etiology or organ-related localization The second part of the somatic dimension is an axis system that enables further medical-somatic information to be encoded. It comprises the six axes of pain localization, topography (spread pattern), temporal characteristics, general genesis, pain quality and additional neurological findings. Manual instructions are not yet available for the MASK-S developed in the early 1990s. For the psychosocial dimension MASK-P there is a detailed description by KLINGER et al. (Klinger et al. 2000). The psychosocial dimension of the MASK enables a behavior-related description of pain-related psychological and social variables on 10 axes. An 11th axis of diagnosis MASK-P diagnoses: Functional relationships serve to integrate the psychosocial abnormalities already differentiated under the preceding axes and represent the actual MASK-P diagnosis. The manual contains a clear rating sheet that facilitates the diagnosis and also serves as a guide for the psychodiagnostic examination 19

27 can be used. The following table gives an overview of the axes and the coding options of the MASK-P: Table 5: Axes and coding of the MASK-P according to KLINGER et al. The MASK-P diagnosis (axis 11) is preceded by the corresponding MASK-S diagnosis in text form: 20

28 Example diagnosis MASK: Local lumbo-sacral back pain after open disc surgery and instability (MASK-S 53517) with depressive-suppressive pain management (MASK-P) The MASK-P allows the experienced user to systematically record and document psychosocial anamnesis data . From the multidimensional description of the pain process obtained in this way, concrete starting points for pain psychotherapeutic interventions can be easily derived and therapy indications can be established. The particular value of the multiaxial pain classification MASK as a whole lies in the systematization of pain syndromes on the basis of a bio-psycho-social understanding of illness and in the standardization and comparability of pain diagnoses. This creates the basic prerequisites for empirical pain research in the German-speaking area and, in the sense of the authors, creates an important contribution to quality assurance in pain therapy.Electronic pain documentation systems In clinical pain measurement and pain (self) observation, computer-aided software applications are increasingly being used. Numerous studies already use electronic pain rating scales (Jespersen et al. 2007; Nebel et al. 2004; Schmidt-Hansen et al. 2007) or pain diaries installed on pocket computers (PDAs) (Giffin et al. 2003; Goldberg et al. 2007; Ott and Scholz 1999; Roelofs et al. 2004; Stinson et al. 2006). In comparative and validation studies, the electronic recording systems even have a better acceptance by patients (compliance) and a higher accuracy (Jamison et al. 2001; Palermo et al. 2004; Stone et al. 2003). Pain-related questionnaire procedures are also often available in both a paper-and-pencil and a software version (Geissner 2001; Heuser and Geissner 1998; Maurischat et al. 2006). The software versions offer the advantage that data entry is not required or is done by the patient and the evaluation can be carried out at the push of a button. Several computer-aided pain documentation systems are now available for the German-speaking area

29 Pain measurement values ​​and questionnaire information also contain functions for the entire patient management (e.g. diagnosis and performance data management) PAIN The first computer-aided, network-compatible pain documentation system in Germany, the PC application PAIN, which is based on the MS-DOS or Novell operating system and the database software dbase , was developed by HILDEBRANDT's working group in Göttingen and used in a multicentre manner (Bautz et al. 1989; Bautz et al. 1990; Hildebrandt et al. 1987; Hildebrandt et al. 1996; Klar et al. 1984; Weyland et al. 1987 ; Wieding et al. 1987). Figure 5: PAIN software - main menu The PAIN software enables the acquisition and evaluation of patient and treatment-related data in a multi-user environment and in the 1980s it met a high technical standard in medical IT. The program saves the data in three main tables: master data, basic data and progress data, which are linked via the patient number. The master data includes the identifying personal data of the patient and other, comparatively stable, case-related data (e.g. name, gender, date of birth, address, telephone numbers, name and address of the insurer, the family doctor and the referring doctor). 22nd

30 Extensive anamnestic and diagnostic information can be stored in the table of basic data. The data set is based on an earlier version of the German pain questionnaire (section) and contains, in addition to detailed pain information, psychological and socio-demographic data. The coding of the diagnosis is based on ICD-9 (500 pain-relevant diagnoses included in the program), DSM-III-R (American Psychiatric Association 1987) and according to the IASP classification scheme (Merskey 1986) or in later program versions according to MASK-S and MASK-P (Section 1.2.4). A tumor pain module enabled the documentation of oncological diagnosis and treatment data. The individual patient contacts with the associated treatment services and medication data are stored in a third table of the PAIN program (progress data). The underlying lists of encryptable services and medications are tailored to a university pain clinic. A progress report in free text form can be created for each contact. Figure 6: PAIN software - basic data for main pain The PAIN input masks are designed in form. The data is only entered using the keyboard. Numerous numerical and letter codes are used here (Figure 6). The program contains numerous routines and work aids for everyday pain therapy work (e.g. plausibility check of the data entered, automated brief doctor's letters, routine for re-appointment 23

31 of patients e.g. B. for follow-up examinations, automated dunning letters in the case of missing transfer slips, printout of all data, etc.). In addition to pain therapy documentation, PAIN is also intended to answer scientific questions and to provide standardized therapy control (Bautz et al. 1989). The program contains its own functions for this (e.g. evaluation of a change questionnaire based on the German pain questionnaire as a pre-post comparison) and provides the collected data in various export formats for further questions and statistical calculations. The PAIN program was used in numerous pain therapy facilities until the QUAST software was released (see next section). The multicenter data obtained was partially evaluated for scientific purposes. PAIN is now considered obsolete in terms of content (use of the ICD-9 and an outdated version of the German pain questionnaire) and software (MS-DOS-based; only partially compatible with Microsoft Windows; no mouse operation) QUAST The name of the pain documentation software QUAST is available for quality assurance in pain therapy. The core idea of ​​this system is the comparability of the data of pain therapy facilities with each other. The German Society for the Study of Pain (DGSS) initiated the development of QUAST in 1994 to enable an external control body to compare the pain therapy process and outcome quality of various pain therapy institutions (Gockel and Maier 2000). The development work was largely carried out by the DGSS quality assurance, documentation and IT working group in pain therapy. From 1998 to 2000 QUAST was tested in 23 pain therapy facilities and evaluated on over patients. The program, which is distributed by DGSS, is now in use at over 100 institutions. QUAST is in constant revision and further development. The following description of the program refers to the version 1.0 dated (Gockel and Maier 2003) available to the author and to the version dated (Gockel and Maier 2004) of the program manual. QUAST requires the database software FileMaker Pro in version 5 or 6 (FileMaker GmbH, Unterschleißheim), which can run in both Windows and MAC-OS environments. If QUAST is operated in the network, the 24th

32 server program FileMaker Server (version 5) must be installed on a computer in the network. The QUAST software is provided by DGSS for a fee. In addition, the named database (a separate license for each input computer) and the server software must be purchased. The QUAST pain documentation software is essentially based on the German pain questionnaire in the version valid until 2007 (DGSS 1997) (Figure 7). An adaptation to the new version of the DSF is in preparation (status: August 2007). Figure 7: QUAST software - pain information from the QUAST initial questionnaire has a modular structure and is evaluation-oriented. In terms of content, it covers all relevant aspects of diagnosis and therapy for patients with chronic pain disorders. With the help of differentiated evaluation routines and a universal data export function, both internal and external quality assurance should be possible. Table 6 on page 26 gives an overview of the QUAST program functions: 25

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