On the care situation for patients with spastic movement disorder in Germany
Spastic movement disorder (short: SB; synonymous use: spasticity, spasticity) is the name given to the increased health-dependent muscle tension resulting from damage to the central sensorimotor system as well as uncontrolled cloni, spasms and spastic dystonias [1]. The most common cause of SB is a stroke, but multiple sclerosis, traumatic brain injury, a spinal cord lesion or cerebral palsy can also cause so-called spastic paralysis [2]. It is assumed that around 250,000 patients in Germany are affected [3]. Depending on the underlying disease, SB can manifest itself at very different times in the course of the disease [4, 5]. Between 20 and 40% of patients develop SB within the first year after the stroke [3, 6-8]. In patients with multiple sclerosis, approximately half of the patients are affected by SB during the course of their disease [9-11]. It is not uncommon for SB to cause nursing restrictions or dependencies in carrying out activities of daily living and pain, which is accompanied by a significant reduction in the patient's quality of life [12, 13]. If adequate therapy is provided too late or insufficiently, complications such as pain, contractures, skin lesions up to pressure ulcers and significant impairment of activities of daily living can result. To avoid this, it is therefore advisable to initiate management of SB as early as possible, when the first relevant symptoms appear [14].
>> A variety of treatment options are available for the treatment of SB, which should ideally be implemented as part of a multi-professional and interdisciplinary care concept. The corresponding diagnostics and the therapy recommendations derived from them are now mostly in the hands of rehabilitation clinics, practicing neurologists and also general practitioners. In accordance with the guidelines, in addition to physiotherapy, physical and redressal measures such as orthoses and plaster casts are also used, depending on the type and severity of the SB. Available drug treatment approaches include oral antispastic medication or injections with botulinum neurotoxin type A (BoNT/A) as well as the use of intrathecal baclofen pumps. Plastic or orthopedic operations can be useful in chronic cases with complications [15, 16]. According to German and international guidelines [16] and the findings from evidence-based reviews [17], local treatment in the form of BoNT/A injections every 3 months is recommended for focal and multifocal forms of SB [6, 15, 17-19 ].
However, in the actual care reality of those affected, these evidence-based treatment methods such as BoNT/A, ITB and physiotherapy and occupational therapy are used little or not regularly and across the board in Germany. The care therefore has characteristics of incorrect or under-supplied care [5, 15, 16, 20-22]. The oral drug treatment used instead for patients with SB usually represents incorrect care [10, 21-23], as this is often associated with severe side effects and accompanying symptoms, such as sedation of the patient [15, 16 ]. A restriction to oral medicines applies to a greater extent if treatment is not carried out by general practitioners alone in accordance with the guidelines. For these reasons, interdisciplinary collaboration with appropriate neurological and rehabilitation specialists appears to be essential as part of guideline-based care.
Chronic SB can also have serious economic consequences if complications arise. In addition to ongoing treatment and care costs, it is also important to take into account the loss of income for the patient and caring relatives, which is accompanied by losses in health and pension insurance [3, 22].
In the following, the reality of care in relation to the treatment of patients with SB by general practitioners, practitioners and internists will be examined in more detail. The presented results of an evaluation of a survey can provide valuable information about care problems or gaps that, if properly addressed, can contribute to the future development of more effective care concepts for patients with SB.
methods
The results of a survey of general practitioners, general practitioners and internists using a two-page questionnaire to evaluate the care situation of patients with SB are presented. This questionnaire was developed specifically for surveying practicing general practitioners. In order to reflect the current reality of care in Germany as realistically as possible, the methodological choice was a non-interventional, retrospective study design. This ensures that treatment decisions were at the discretion of the participating physicians and could not be influenced by the survey or external stimuli.
The questionnaire consists of a total of 26 questions on general information about the patient clientele and the underlying disease, the non-invasive treatment methods, the drug therapies used and the collaboration with other specialist disciplines.
To recruit potential participants, a postal mailing was carried out to 2,000 randomly selected general practitioners in Germany. The data was prepared in an Oracle database and then evaluated using descriptive-statistical methods.
Results
The presentation of the results can be divided into two parts. Firstly, information on the demographic structure and secondly on the clinical picture of the patient population and the reality of care within the framework of general medical treatment. In addition to information on current medical and non-medicinal care, the latter also contains detailed information about the interdisciplinary integration of the general practitioners surveyed in the sense of a cross-sector care concept. First, the results of the sociodemographic and disease-specific information will be presented.
Patient collective and documentation of spastic movement disorder
At the end of the database, there were a total of fully completed questionnaires from 109 general practitioners that could be included in the analysis. This corresponds to a response rate of 5.5%. Taking into account the perception and recognition of the health care problems described, the response rate is not excessively low compared to comparable surveys among general practitioners.
The 103 general practitioners surveyed (6 did not provide information on the number) were caring for a total of 2,418 patients with SB at the time of data collection. This number represents the underlying patient population of the present evaluation and corresponds to an average of more than 24 patients per general practitioner. A single physician reported only one patient with SB. The documented maximum was 125 patients affected by SB.
Slightly more than 73% of these patients visit their general practitioner between 3-12 times per year because of SB. With almost 12% of patients, the number of visits for the treatment of SB is only 1-3 visits per year. 13.8% receive general medical treatment at least once a month.
In order to describe the age structure of the patient population examined, the general practitioners were asked to document which age group, in their experience, is most often affected by SB. In this context, half of the general practitioners emphasized the age group of patients over 65 years (50%). The age group of employed people between 30 and 65 years of age was mentioned only slightly less frequently, by 42% of the general practitioners surveyed. This is a key finding for the health economic evaluation of the effects of SB in connection with social productivity losses (indirect costs).
In addition to the average of 24 patients treated, a total of 390 patients with a new diagnosis of SB were also documented. This corresponds to an annual rate of an average of 4-5 new patients with SB requiring treatment per doctor. In some cases, there were up to 20 new diagnoses of SB per doctor. This clearly shows that the care of patients with SB by general practitioners is not an exception, but can be observed across the board.
As explained in the introduction, the causes for the development of SB can be diverse. The general practitioners were therefore asked to indicate what causes were observed in the patients with SB they treated. As expected based on epidemiological data [24], stroke was listed as the most common cause overall (92.7%). In addition, almost a third of the general practitioners surveyed documented multiple sclerosis as the cause of the development of SB. There were also isolated reports from up to 10% of all doctors about patients who had SB due to a traumatic brain injury, a spinal cord lesion or cerebral palsy. A detailed representation of the frequency distribution of the documented causes can be found in Figure 1.
In addition, the specific form of SB, which according to the general practitioners occurs most frequently, was also asked. More than half of the medical profession (53%) documented hemilateral spasticity as the most common form, in which one arm and one leg of the respective patient are affected. However, just over a fifth of the doctors surveyed reported predominantly regional SB, which only affected individual limbs. Only 3.7% of general practitioners mentioned focal spasticity, and a further 12.8% mentioned multifocal spasticity as the most common manifestation in their own everyday general medical treatment. Slightly fewer than 10% of general practitioners mainly treat patients with a generalized form of spasticity.
When assessing the social and health economic consequences of SB, the level of care required by the corresponding patients can provide important information. Overall, the general practitioners stated that an average of 76.9% of patients with SB also had a level of care. In this context, it was also noted that almost two thirds of the patients were assigned to a higher level of care due to restrictions imposed by the SB.
The most commonly documented level of care for patients with SB is level of care 3 (35%). The 2nd (23%) and 4th level of care (21%) were also documented by a significant number of general practitioners as the most common level of care for patients with SB. Care levels 1 (2.8%) and 5 (7.3%) were listed comparatively rarely.
Many patients also report psychological side effects in the course of developing SB. Depression is a common diagnosis in this context. The proportion of patients who develop depression due to their SB, estimated by general practitioners, is an average of 45% of affected patients. The increased incidence of depression can be linked, at least in part, to the incorrect or under-provided care described. In this context, it becomes clear that SB is not only a symptom of other underlying diseases, but can also potentially promote other health problems in many cases. The importance of caring for patients with SB should be based on this circumstance instead of treating SB as an isolated symptom.
Care by the general practitioner
The primary objective of this publication is to describe the standard care of SB in need of treatment by general practitioners, practitioners and internists and to answer the question of the extent to which this corresponds to guideline-based, interdisciplinary treatment.
The following results therefore shed light on the treatment of these patients by general practitioners. In addition to information on medication consumption and the number of doctor visits, this also includes documentation of referrals to specialists (e.g. neurologists) and therapists (occupational and physiotherapists) as well as the further use of medical devices and aids.
Based on the last question from the section on the patient population, we first asked how general practitioners proceed in the event of depression caused by SB. In 73% cases, the resulting depression is treated by the general practitioner himself. Almost half of the patients affected by depression (48%) are referred (sometimes additionally) to a specialist.
The focus of the following questions is specifically on the treatment of SB by the general practitioner or through referral to other specialists. All 109 general practitioners stated that they frequently prescribe physiotherapeutic measures as non-invasive therapeutic methods for the treatment of SB. Orthoses and redressal bandages as well as acupuncture were used much less frequently in the context of general medical care. Only 17.3% of those surveyed frequently prescribe orthoses or corrections. This value is even lower for acupuncture, as a treatment measure for accompanying pain in SB (4.3%).
Regular occupational and physiotherapeutic measures are essential for guideline-compliant treatment of SB, which is why we also asked how frequently these measures are carried out.
More than half of general practitioners reported that the patients with SB they treat received an average of 12 physiotherapy sessions per quarter. That equates to less than one session per week. 38% of general practitioners documented twice the number of 24 sessions per quarter. Only four doctors (4%) prescribed a higher number of physiotherapy sessions.
The number of physiotherapeutic measures that was often too low compared to the guideline requirements was justified by 39% of the doctors due to the lack of clinical success of these measures. Lack of or only limited cost coverage by health insurance companies was also documented as a possible cause by more than a third (36%) of doctors. The other, somewhat less frequently documented reasons for the lack of occupational and physiotherapeutic measures are also relevant from a healthcare perspective. For example, more than a fifth (21%) of doctors stated that the affected patients refused physiotherapy. A further 10% stated that they did not see a sufficient indication for physiotherapeutic measures or that physiotherapeutic care close to home and therefore reasonable for the patients could not be guaranteed.
In addition to physiotherapeutic measures, the relevant guidelines of the specialist societies also provide for drug treatment of SB if the effect of physiotherapy is not sufficient. Therefore, data on medication care provided by general practitioners was also collected. First, the basic prescription of antispastic medications was asked. Almost half of general practitioners (49%) regularly prescribe antispastic drugs to patients with SB. A detailed list of the oral antispastic drugs mentioned can be found in Figure 2.
More than 80% of general practitioners use oral baclofen to treat SB. Gabapentin (65%), tolperisone (38%) and L-DOPA (35%) are also frequently used. Since only half of all general practitioners stated that they provided their patients with SB with medication, the lack of oral antispastic medication was also questioned. According to the doctors, the main reason for this in almost 40% cases is that the patient refuses to take the medication. Insufficient clinical success through prescription of medication (38.5%) and lack of medical indications (21.1%) were also listed as reasons for non-treatment with medication.
In addition to prescribing oral antispastic drugs, treatment with BoNT/A injections is a guideline-compliant treatment option for patients with focal SB. Using a visual analogue scale, fewer than 10% of general practitioners stated that their patients' SB was treated with BoNT/A. 46% of general practitioners even stated that none of the patients they treated received this treatment alternative. The reasons for not treating with BoNT/A were also recorded. 43% of doctors reported that no BoNT/A therapy user was available in the area. In addition, reference was made to insufficient medical indications (19%), rejection on the part of the patient (18%) and inadequate reimbursement of costs by health insurance companies (17%). Almost a quarter of the medical profession did not provide any information on this question, which also allows conclusions to be drawn about the importance of BoNT/A treatment.
Oral treatment with baclofen is the most common medical treatment among general practitioners, but on average general practitioners only reported that an intrathecal baclofen pump was used for only 2.5% of their patients affected by SB. This treatment alternative is documented even less frequently in general medical care than treatment with BoNT/A, but is only indicated for affected patients with widespread SB (e.g. tetraspasticity).
Instead, the general practitioners state that for more than half of the patients (54%), care at SB consists of the administration of oral painkillers. The most relevant analgesic groups used to treat pain associated with SB are NSAIDs (70%), pyrazolones (68%), co-analgesics (65%) and opioids (54%).
Guideline-based treatment of patients with SB should follow a multi-professional and interdisciplinary treatment approach, which should be complemented by general medical treatment as well as occupational therapists, physiotherapists and neurologists and, if necessary, by other rehabilitative specialist groups. The proportion of patients who are referred to another specialist due to spasticity by the general practitioners surveyed is on average 62%. Around a quarter of general practitioners refer patients with SB in fewer than 35% of all cases. If a referral to a specialist took place, in most cases this happened every six months (39%) or annually (33%). Only a quarter of general practitioners refer their own patients with SB once or several times per quarter.
The reasons for referral to a specialist can be varied. For more than two thirds (69%) of general practitioners, specialized treatment of the underlying disease is the main reason for referral. 56% refer their patients (in addition) for specialized treatment of SB. The patient's specific request for a referral (39%) and the initiation of rehabilitation measures by the general practitioner (26%) are also among the listed reasons for referral.
Not only the referral rates play a role, but also which specialist disciplines are in the foreground. All general practitioners agreed that neurologists should be consulted in SB. Since knowledge about the relevance of the interdisciplinary treatment strategy and the central role of neurologists seems to already exist here, this leaves further questions unanswered about the causes of the rather low referral rates. In addition to referrals to neurological specialists, around a quarter of doctors also consider co-treatment with orthopedists and rehabilitation specialists to be relevant.
discussion
Comparing the actual reality of care for patients with SB documented by general practitioners with the guideline recommendations [16] provides clear evidence of incorrect or under-care for many affected patients. This is particularly true if the treatment is not carried out multi-professionally (without physiotherapists and occupational therapists) and not interdisciplinary, but exclusively by the general practitioner. The reasons for this can be deficiencies in cross-sector care, often insufficient support for patients and difficult access to information and/or specialists. In addition, service providers may also face hurdles regarding reimbursement of services. For example (with the exception of a special regulation in Bavaria1) there are no billing numbers (EBM, GOÄ) for treatment with BoNT/A; In most cases, the statutory health insurance does not provide for the reimbursement of costs for off-label use [25].
In addition, general practitioners generally do not treat SB with BoNT/A due to a lack of specialization. Against this background, referrals to specialists (especially neurologists) do not occur frequently enough. This is particularly surprising because physicians consistently stated that neurology is viewed as a key specialty for SB referrals. This indicates a discrepancy between the knowledge about the importance of an interdisciplinary treatment strategy and one's own practice. Even if there is a referral to a neurological specialist, the comprehensive supply of users of BoNT/A or intrathecal baclofen treatment, especially in rural regions, must first be ensured. Improvements in the quality of treatment for patients go hand in hand with the expansion of an efficient interdisciplinary care structure.
The SB treatment should follow a multiprofessional and interdisciplinary approach, which includes physiotherapeutic treatments (e.g. passive muscle stretching procedures) and, if necessary, antispastic medication. In addition, a holistic care concept should also provide improved treatment options to reduce pain and options to facilitate and avoid care as well as to mitigate secondary illnesses (e.g. depression). The exclusive treatment with oral baclofen, which is practiced in many cases, is not considered sufficient to achieve these objectives. For example, the guideline-based, recommended basic therapy for focal, multifocal and regional SB is instead a combination of physiotherapeutic treatment and BoNT/A [15, 16]. However, the results presented for patients with SB treated by general practitioners make it clear that the reality of care is so far far removed from these recommendations from the guidelines of the specialist societies. It is therefore not possible to speak of establishing comprehensive and long-term care with sufficient capacity for physiotherapy in combination with neurological and drug treatment in Germany [21, 25]. However, it should not be forgotten that general practitioners have cited the lack of suitable users of this therapy option as the main reason for not using BoNT/A therapy. Therefore, improvements must also be made in the neurological sector in order to be able to provide a comprehensive care structure for the use of BoNT/A injections in SB.
A controlled study (evidence level 1a) on the effectiveness of BoNT/A treatment compared to oral antispastic drugs shows that patients treated by general practitioners are significantly longer and more exposed to functional impairments than patients treated with local BoNT/A treatment [26]. This is also evident from the results of a non-interventional study in Germany [27]. The present evaluation is therefore not the first work to address the care problems of patients with SB in the context of general medical treatment practice.
The results also make it clear that the care of SB by general practitioners is not just short-term, but rather chronic. Since in many cases the care is provided exclusively by general practitioners and is not just a transition point for patients on the way to specialist neurological and guideline-compliant treatment, it should also be possible to ensure that patients receive care in accordance with the guidelines.
Egen-Lappe et al. showed in an analysis of data from statutory health insurance that the proportion of patients who received at least oral muscle relaxants due to SB was only 13%. In this analysis, not a single patient received intrathecal baclofen or BoNT/A [5]. The results from the aSPEkt study were not quite as clear, but still far from the treatment recommendations of the guidelines [15, 16]. In this context, Katzenmeyer [3] reports that only a quarter of all patients receive antispastic drug therapy or physiotherapy.
The present evaluation builds on this work in an argumentative manner and attempts to highlight the need for care for patients with SB that is more closely aligned with the guidelines of the specialist societies.
Although physiotherapy is frequently used by all general practitioners surveyed, a closer look shows that not all patients use it in the long term. General practitioners cite a lack of clinical success and limited cost coverage by health insurance companies as the main reasons for the lack of physiotherapeutic measures. In addition to the correct care practices of general practitioners, patient compliance with SB is also extremely relevant. Only 62% of the patients are referred to a specialist. In most cases this happens 1-2 times a year. Despite the high value that general practitioners place on neurological co-treatment, the values of patients treated with BoNT/A or an intrathecal baclofen pump are very low. Together with the low referral rates and failures in physiotherapeutic measures (not even by the general practitioner), clear signs of undercare can be seen here. In this context, the increased general medical use of oral antispastic drugs (which itself is often associated with side effects [15, 16]) can be viewed at least in part as incorrect care. In this context, the health services research study by Rychlik et al. which, in addition to higher responder rates and an increase in quality of life, also documented a better cost-effectiveness ratio for patients who are also treated locally with BoNT/A injections for focal and multifocal SB after stroke [22].
In order to assess the economic impact of such incorrect care, the results of the process analysis should be linked to transition probabilities in a next step, which should also enable an economic evaluation of the care situation in connection with the general medical treatment of patients with SB. In order to be able to improve the care situation in the long term and sustainably, it is important that the (neurological and general medical) professional associations and specialist societies devote more attention to the topic of SB and, in addition, that liabilities are established between both groups of doctors in the context of the care of SB. Interdisciplinary collaboration must not only function as an additional treatment option, but should be a mandatory, integral part of patients with SB.
Educational work on the course of the disease and treatment recommendations can also lead to an improved and more efficient care situation for both the medical profession and the affected patients and relatives.
The effectiveness of local BoNT/A treatment has been proven in numerous controlled studies with a high level of evidence [19, 26, 28, 29] and should therefore be integrated into everyday care. This requires the collaboration of general practitioners and specialists who use BoNT/A. Also the framework conditions (e.g. the
The lack of billing figures for treatment with BoNT/A outside Bavaria) on the part of the service providers should promote care in line with guidelines instead of standing in the way. The ultimate goal is not only to provide patients with more efficient, guideline-compliant care, but also to avoid costly rehabilitation and care cases. In the best case scenario, this would result in an increased quality of life for patients and economic relief for service providers.
The non-interventional study design must be mentioned as a limitation. This was chosen in order to reflect the heterogeneity of the treatment and management of SB and general medical care practice in Germany as realistically as possible. The evaluation of average information from a general practitioner can never be as detailed as dedicated documentation for individual patients. However, this would not correspond to the aim of the present work, which was to uncover fundamental tendencies and problems in the general medical care practice of patients with SB. A general practitioner can often recognize such tendencies better through the summary description of his patient group than through individual documentation of the corresponding patients.
The higher values for the number of physiotherapeutic and drug-antispastic treatments compared to the evaluations of process-produced routine data (e.g. GKV data) could also be due to a selection bias and be an expression of a particularly “careful” documentation of a treatment practice that is perceived as optimal in the survey context. The fact that some of these values still lag significantly behind the guideline requirements underlines the urgency of the issue. <<
