[Validated German PROMs for People with Major Amputation of the Lower Extremity - A Narrative Review Based on the Final Report of the LEAD and COMPASS Initiative of the ISPO]. / Validierte deutschsprachige PROMs für Menschen mit Majoramputation der unteren Extremität ­ Ein narrativer Review anhand des Abschlussreports der LEAD- und COMPASS-Initiative der ISPO.

Patient-reported outcome measures (PROMs) play an important role in the rehabilitation of people with major limb amputations. Patient-completed questionnaires help collect specific constructs on this patient population. The COMPASS and LEAD initiatives, carried out by the International Society for Prosthetics and Orthotics (ISPO), underscore the importance of regularly collecting high-quality PROMs. These are essential for the evaluation of rehabilitation needs, progress, and success. In the final report of ISPO's major international initiative, PROMs recommendations of the expert panel are tabulated. In Table 3.2 of the report, ISPO lists n=12 PROMs that were included in the narrow consensus process were considered to be of acceptable quality, and therefore recommended. The aim of this systematic review was to specifically search for these recommended PROMS regarding their availability in a German and validated version in order to identify potential gaps. All PROMs that were available in a German and validated version were then examined further with regard to the quality of the validation study, using the checklist of COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Through a systematic literature search, six validated German-language versions were found. Only four of these met the quality standards of the COSMIN checklist sufficiently. Overall, this review shows serious gaps in the availability in the German language of validated versions of PROMs used internationally and recommended as standard by the ISPO. This gap needs to be closed by guideline-oriented translation and subsequent validation studies in order to be able to offer and collect the PROMS recommended by the ISPO also for German-speaking patient populations.

Effects on temporomandibular disorder in the treatment of tension-type headache with acupuncture and therapeutic exercises. A secondary analysis from a randomized controlled trial.

OBJECTIVES: To examine the effects of acupuncture and therapeutic exercise alone and in combination on temporomandibular joint symptoms in tension-type headache and to evaluate the potential interaction of existing temporomandibular dysfunction on the success of headache treatment. DESIGN: Pre-planned secondary analysis of a randomized controlled, non-blinded trial. SETTING: Outpatient clinic of a German university hospital. SUBJECTS: Ninety-six Participants with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups. INTERVENTIONS: Six weeks of acupuncture or therapeutic exercise either as monotherapies or in combination, or usual care. Follow-up at 3 and 6 months. MAIN MEASURES: Subjective temporomandibular dysfunction symptoms were measured using the Functional Questionnaire Masticatory Organ, and the influence of this sum score and objective initial dental examination on the efficacy of headache treatment interventions was analyzed. RESULTS: Temporomandibular dysfunction score improved in all intervention groups at 3-month follow-up (usual care: 0.05 [SD 1.435]; acupuncture: -5 [SD 1.436]; therapeutic exercise: -4 [SD 1.798]; combination: -3 [SD 1.504]; P = 0.03). After 6 months, only acupuncture (-6 [SD 1.736]) showed a significant improvement compared to the usual care group (P < 0.01). Subjective temporomandibular dysfunction symptoms had no overall influence on headache treatment. CONCLUSIONS: Only acupuncture had long-lasting positive effects on the symptoms of temporomandibular dysfunction. Significant dental findings seem to inhibit the efficacy of acupuncture for tension-type headache.

Health System's Role in Facilitating Health Service Access among Persons with Spinal Cord Injury across 22 Countries.

(1) Background: Despite efforts to improve access to health services, between- and within-country access inequalities remain, especially for individuals with complex disabling conditions like spinal cord injury (SCI). Persons with SCI require regular multidisciplinary follow-up care yet experience more access barriers than the general population. This study examines health system characteristics associated with access among persons with SCI across 22 countries. (2) Methods: Study data are from the International Spinal Cord Injury Survey with 12,588 participants with SCI across 22 countries. Cluster analysis was used to identify service access clusters based on reported access restrictions. The association between service access and health system characteristics (health workforce, infrastructure density, health expenditure) was determined by means of classification and regression trees. (3) Results: Unmet needs were reported by 17% of participants: lowest (10%) in Japan, Spain, and Switzerland (cluster 1) and highest (62%) in Morocco (cluster 8). The country of residence was the most important factor in facilitating access. Those reporting access restrictions were more likely to live in Morocco, to be in the lowest income decile, with multiple comorbidities (Secondary Conditions Scale (SCI-SCS) score > 29) and low functioning status (Spinal Cord Independence Measure score < 53). Those less likely to report access restriction tended to reside in all other countries except Brazil, China, Malaysia, Morocco, Poland, South Africa, and South Korea and have fewer comorbidities (SCI-SCS < 23). (4) Conclusions: The country of residence was the most important factor in facilitating health service access. Following the country of residence, higher income and better health were the most important facilitators of service access. Health service availability and affordability were reported as the most frequent health access barriers.

Effects of acupuncture and medical training therapy on depression, anxiety, and quality of life in patients with frequent tension-type headache: A randomized controlled study.

OBJECTIVES: To compare the effects of acupuncture and medical training therapy in combination or individually with usual care on quality of life, depression, and anxiety in patients with tension-type headache. METHODS: In this single-center, prospective, randomized, controlled, unblinded trial, 96 adults (38.7(+/-13.3) years of age; 75 females/20 males/one dropout) with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups (n = 24). The treatment groups received six weeks of either acupuncture or medical training therapy as monotherapies or in combination (12 interventions each), or usual care. We assessed depressiveness (PHQ-9), anxiety (GAD-7), and health-related quality of life (SF-12) as secondary outcome parameters at baseline, six weeks, three months, and six months after initiation of treatment. Linear mixed models were calculated. RESULTS: Both, acupuncture (baseline to six-weeks change scores: mean: -2(standard deviation: 2.5 points), three months: -2.4(2.4), six-months -2.7(3.6)) and the combination of acupuncture and medical training therapy (-2.7(4.9), -2.2(4.0), -2.2(4.2)) (each within-group p < .05) significantly reduced depressiveness-scores (PHQ-9) to a greater extent than medical training therapy (-0.3(2.0), -0.5(1.6), -0.9(2.6)) or usual care alone (-0.8(2.9), 0.1(2.8), 0.2(3.6)). We found similar results with anxiety scores and the physical sum scores of the SF-12. No severe adverse events occurred. CONCLUSIONS: Acupuncture and the combination of acupuncture and medical training therapy elicit positive effects on depression, anxiety, quality of life, and symptom intensity in patients with episodic and chronic tension-type headache. Acupuncture appears to play a central role in mediating the therapeutic effects, underscoring the clinical relevance of this treatment. An additive benefit of the combination of both therapies does not appear to be relevant.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.

Test of the Rehabilitation Goal Screening (ReGoS) Tool to Support Decision Making and Goal Setting in Physical and Rehabilitation Medicine Practice.

BACKGROUND: It has already been shown that it is feasible to use International Classification of Functioning, Disability and Health (ICF) Sets as self-assessment instruments. We used this idea to design an ICF-based screening tool to assess patients of a broadly based rehabilitation department. It was developed for the purpose of having a screening tool before taking the anamnesis, as well as for rehabilitation planning and follow-up. METHODS AND MATERIALS: The Rehabilitation Goal Screening (ReGoS) instrument is a self-report questionnaire which was developed based on the most relevant domains from the ICF Core Sets for chronic pain and rehabilitation. The ICF categories were translated into plain language and 0-10 Likert scales were used. A retrospective analysis of routine clinical data using the ReGoS tool, Work Ability Index (WAI) and Hospital Anxiety and Depression Scale (HADS) in paper- or tablet-based form was performed. RESULTS: The average age of the N = 1.008 respondents was 53.9 years (SD = 16.2). Of the respondents, 66% (n = 665) were female. At the time of the survey, 48.3% (n = 487) of the patients were employed. ReGoS results demonstrated that the highest restrictions on a scale from 0 to 10 were found in the areas of energy and drive (M = 5.79, SD = 2.575) and activities of daily living (M = 5.54, SD = 2.778). More than a third of the respondents rated their work ability as critical. CONCLUSION: The use of the ReGoS instrument as an ICF-based screening tool based on a self-report questionnaire provides relevant information for clinical diagnosis, participative goal setting and a detailed functional capacity profile.

Which factors have an association to the Quality of Life (QoL) of people with acquired Spinal Cord Injury (SCI)? A cross-sectional explorative observational study.

STUDY DESIGN: Cross-sectional explorative observational study. OBJECTIVES: To identify factors which have an association to the self-perceived Quality of Life (QoL) for persons with acquired spinal cord injury (SCI). SETTING: Eight specialized SCI-centers in Germany. The GerSCI survey is the German part of the International Spinal Cord Injury Survey (InSCI). METHODS: Self-disclosure questionnaire, created from the InSCI group, translated and adapted for Germany. The questionnaire collects a very broad range of data and, and due to its design as a self-report, is particularly suitable for the analysis on QoL. Because of the content, which is binding for all participating states, it allows a direct comparability of the results. Included in Germany were 1479 persons with acquired SCI aged 18 years and older. RESULTS: Various factors were identified with high associations to QoL, including changeable and unchangeable ones, such as those of particular importance: pain, sleep problems, sexual dysfunction, age, and time since onset of SCI. Some results confirmed reports of previous studies, others were surprising. CONCLUSION: this study provides an important basis for the planned analysis of the InSCI participating countries in the 6 WHO regions. Germany was able to contribute the largest study population. The concrete study design of InSCI allows us to directly compare data and helps us to improve ourselves within the framework of a "learning health system". Medical measures can be orientated towards the found results, in order to ensure the best possible care and support by the therapeutic team, individually adapted to the person, place of residence and impairment.

[Translation, Adaptation, Reliability and Validity of the German Version of the Prosthesis Mobility Questionnaire 2.0 (PMQ) on Patients with Major Lower Limb Amputation]. / Übersetzung und transkulturelle Adaptation des Prosthesis Mobility Questionnaire 2.0 (PMQ) ins Deutsche und dessen Reliabilität und Validität bei Patienten mit Majoramputation der unteren Extremität.

PURPOSE: The aim of this prospective validation study was to translate the Prosthesis Mobility Questionnaire 2.0 (PMQ) into German based on a guideline, following by psychometric testing for its validity and reliability using classical test theory. METHODS: The PMQ was translated into German according to ISPOR guidelines using double forward and double backward translations, finalized by pilot testing (N=10). Subsequently, assessment of the validity and reliability was performed from March 2020 to August 2020 on N=61 patients with unilateral lower limb amputation. Construct validity was determined by using the German version of the Locomotor Capabilities Index-5 (LCI-5-D), the Rivermead Mobility Index (RMI), the Timed up and go Test (TUG), and K-levels. Cronbach's alpha was calculated to check internal consistency and discriminatory power was determined by item correlations. Test-retest reliability was calculated using ICC (2,1). Based on the ICC, the minimum detectable difference (MDC) was calculated. RESULTS: The translation process required small changes after the pilot test. The validation study was performed on N=61 patients (56.59±13.16 years, m/f=38/23). A mean PMQ of 26.23±8.89 points was achieved. Ceilings or floor effects for total score did not appear. Construct validity showed strong positive correlations to LCI-5-D (r=0.74, p<0.001), RMI (r=0.63 p<0.001) as well as k-levels (r=0.61 p<0.001) and moderate negative correlation to TUG (r=- 0.49, p<0.001). Internal consistency was excellent with Cronbach's alpha=0.95). All items showed a value greater than r=0.40 for item-to-total score correlation. Test-retest reliability was excellent with an ICC (2,1)=0.98 with a timespan between T0 and T1 of 3.2±2.83 days. Based on this results, the MDC was 3.40 points. CONCLUSION: The German version of the Prosthesis Mobility Questionnaire 2.0 is a valid, reliable patient reported outcome measure (PROM) for measuring mobility and functional ability of patients with exoprosthesis due to unilateral lower limb amputation. It can be used for a German-speaking population.

"Fit for work and life": an innovative concept to improve health and work ability of employees, integrating prevention, therapy and rehabilitation.

OBJECTIVES: To set up a comprehensive health programme for employees, with needs-based allocation to preventive and rehabilitative measures; and to evaluate the effects of the programme on work ability and sick leave. DESIGN: Prospective single-group observational study. METHODS: Employees of a university hospital were invited to participate in needs-based interventions of preventive or rehabilitative character. Allocation followed screening questionnaires, anamnesis and clinical examination. The selection of a preventive or rehabilitative measure appropriate to the needs of the patient followed screening questionnaires, anamnesis and clinical examination. Preventive offers can include back training courses, water gymnastics or stress management exercises. Rehabilitative measures can include 3-6 weeks in- or outpatient rehabilitation or one week intensive outpatient rehabilitation. The main outcome parameters were work ability and sick leave duration. RESULTS: At this time of the project included 1,547 participants, who applied voluntarily to enter the programme. The mean age of participants was 44.3 years (standard deviation (SD) 10.3 years), and 72.0% were female. Needs-based allocation to a prevention (n=1,218) or a rehabilitation group (n=329) was effective, and enabled formation of 2 groups with different needs. Overall, more than half of the employees participating in the programme reported sick leave within the last 3 months. Participants in the preventive measures group reported significantly lower duration of sick leave than those in the rehabilitation group. Employees in the rehabilitation group had significantly lower work ability (Work Ability Index (WAI) 30.4 vs 36.6), but higher effects at 6-month follow-up (WAI 33.4 (standardized effect size (SES) 0.51) vs 37.9 (SES 0.17)). In the prevention group mean sick leave reduced significantly from 1.9 to 1.3 weeks (p < 0.001) during the previous 3-month period, whereas in the rehabilitation group it reduced from 2.7 to 1.5 (p < 0.001) weeks. CONCLUSION: Implementation of the comprehensive health programme was successful, using the multimodal infrastructure of a university hospital. Allocation to suitable interventions in occupational health programmes following screening, anamnesis and clinical examination is an appropriate way to meet participants' needs. The programme resulted in improved work ability and less sick leave.

Combination of acupuncture and medical training therapy on tension type headache: Results of a randomised controlled pilot study.

OBJECTIVES: The aim of this study was to compare the effects of acupuncture and medical training therapy alone and in combination with those of usual care on the pain sensation of patients with frequent episodic and chronic tension-type headache. DESIGN: This was a prospective single-centre randomised controlled trial with four balanced treatment arms. The allocation was carried out by pre-generated randomisation lists in the ratio 1:1:1:1 with different permutation block sizes. SETTING: The study was undertaken in the outpatient clinic of Rehabilitation Medicine of the Hannover Medical School.Participants and interventions: Ninety-six adult patients with tension-type headache were included and randomised into usual care (n = 24), acupuncture (n = 24), medical training (n = 24), and combination of acupuncture and medical training (n = 24). One patient was excluded from analysis because of withdrawing her/his consent, leaving 95 patients for intention to treat analysis. Each therapy arm consisted of 6 weeks of treatment with 12 interventions. Follow-up was at 3 and 6 months. MAIN OUTCOME MEASURES: Pain intensity (average, maximum and minimum), frequency of headache, responder rate (50% frequency reduction), duration of headache and use of headache medication.Clinical results: The combination of acupuncture and medical training therapy significantly reduced mean pain intensity compared to usual care (mean = -38%, standard deviation = 25%, p = 0.012). Comparable reductions were observed for maximal pain intensity (-25%, standard deviation = 20%, 0.014) and for minimal pain intensity (-35%, standard deviation = 31%, 0.03). In contrast, neither acupuncture nor medical training therapy differed significantly from usual care. No between-group differences were found in headache frequency, mean duration of headache episodes, and pain medication intake. At 3 months, the majority of all patients showed a reduction of at least 50% in headache frequency. At 6 months, significantly higher responder rates were found in all intervention groups compared to usual care. CONCLUSIONS: In contrast to monotherapy, only the combination of acupuncture and medical training therapy was significantly superior in reduction of pain intensity compared to usual care.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.

[Spinal Cord Injury in Germany - a Survey on the Living and Care Situation of People with Spinal Cord Injury]. / Querschnittlähmung in Deutschland ­ eine Befragung zur Lebens- und Versorgungssituation von Menschen mit Querschnittlähmung.

PURPOSE: Multiple organizations like UN and WHO call for the collection of internationally comparable data on living and supply conditions of people with disabilities. Furthermore, reliable national data are necessary for ensuring appropriate care. Regarding patients with Spinal Cord Injury (SCI) in Germany, only data on diagnostics or therapeutic interventions is currently available. The International Spinal Cord Injury Survey aims at collecting reliable data of people with SCI in 21 countries and developing recommendations for actions to be taken by policy-makers and other decision-makers. METHODS: In 2017, eight specialized SCI-centers across Germany sent a standardized questionnaire to their patients who had diagnosis of SCI, and were older than 18 years (n=5,598). The questionnaire could be completed paper-based or online. RESULTS: 1,479 patients participated in the study and were included in data analysis. On average, participants were 55.3 years (SD=14.6) old, ¾ were male. The mean time of onset of paralysis was 13.9 years. Two thirds of the spinal cord injury causes were traumatic. In 51.2% SCI was classified as paraplegia. The most frequently cited health problem was sexual dysfunction. Medical treatment for this problem was rarely used. Serious environmental barriers were the inadequate accessibility of private households and public places. 42.5% of the respondents in working age were employed, which is 10% less than in Switzerland. DISCUSSION: Serious problems in environmental barriers, medical care and labor market participation were identified for people with SCI. The results will be reported to and discussed with political decision makers and further actors to create solutions. This requires extensive efforts, like modification in building law and home support.

[Factors Influencing Access to Follow-Up Rehabilitation]. / Einflussfaktoren auf den Zugang in die Anschlussrehabilitation (AR/AHB).

PURPOSE: Identification of patient-related influencing factors on access to follow-up rehabilitation METHODS: Partially standardized, written survey of patients between the ages of 18 and 65 in 3 acute hospitals in Hanover, who were assigned to one of the following six defined indication groups on the basis of their diagnosis: (1) surgically treated bone fractures, (2) knee and hip endoprosthesis, (3) malignant disease from visceral surgery, (4) heart disease without surgical intervention, (5) heart disease with surgical intervention, and (6) stroke. In addition to personal information (such as age and gender) personal rehabilitation goals, rehabilitation motivation, disease processing, functioning, state of health, the knowledge of right to request and suffrage and the personal desire to start a follow-up rehabilitation were raised. RESULTS: Of the 1,227 patients surveyed, 42.5% received follow-up rehabilitation. The percentages between the groups of diagnoses varied widely and were lowest after conservatively treated heart disease (3.2%) and highest after knee and hip joint replacement (98.1%). Including cases with a follow-up rehabilitation relevant diagnosis (n=1,000), the proportion of persons with rehabilitation increased to 51.7% (p<0.001). Reasons for an untreated follow-up rehabilitation were in rare cases the rejection by the payer (0.7%), the rejection by the patient (1.6%) or the lack of rehabilitation ability (3.3%). However in most cases the application remained without further differentiation (28.5%). The most important factor influencing follow-up rehabilitation access were diagnosis. Compared to knee- and hip endoprosthesis, the patients from other relevant diagnosis groups had a much lower chance to start a follow-up rehabilitation (OR from 0,01 up to 0,07; p<0,001). The desire of the patient showed the second most and significant influence to get follow-up rehabilitation (OR=8.18; p<0.001). CONCLUSIONS: The diagnosis was identified as the most important criterion for follow-up rehabilitation access. No measurable factors of functioning seem to have a big influence. Therefore, the individual doctor's decision to submit an application is of particular importance. Especially because of the low level of medical knowledge on the indication catalog of the German pension insurance, the medical treatment based on professional experience as well as the lack of further education possibilities (Gottschling-Lang, 2016), it can be assumed that the follow-up rehabilitation is less standardized and systematic. In order to ensure a need-based patient care, assessment procedures should be established and the training and continuing education of physicians should be supplemented with the topic of follow-up rehabilitation.

Rehabilitation Services Provision and Payment.

Persons with spinal cord injury (SCI) experience disability and have significant need for rehabilitation. To deliver appropriate rehabilitation, interventions and programs suitable services must exist. A prerequisite for system improvement is a description of rehabilitation services. The aim of this paper was to develop a rehabilitation service framework for SCI. Additionally, principles and models of payment of rehabilitation services will be discussed. Health-related rehabilitation services should be available along the continuum of care and implemented at all levels of health care. The three most important types of services are acute, postacute, and long-term rehabilitation services. Health-related rehabilitation services for patients with SCI must be able to provide high-quality equipment and a well-trained, highly specialized and multiprofessional team of rehabilitation workers. The principles of payment for SCI rehabilitation services vary according to the organization of health care systems, which primarily depends on the sources of money (eg, from national health care systems, other health insurances, or out of pocket). Funding systems and payment criteria may influence service provision and justice in service delivery. It is important to analyze the provision of rehabilitation services and the related funding system using uniform assessment and evaluation tools.

Early Workplace Intervention to Improve the Work Ability of Employees with Musculoskeletal Disorders in a German University Hospital-Results of a Pilot Study.

Health promotion is becoming increasingly important in work life. Healthcare workers seem to be at special risk, experiencing musculoskeletal disorders (MSD); their situation is strongly influenced by demographic changes. The aim of this study is to evaluate the feasibility and outcome of a worksite intervention. In a one-group pretest-posttest design, 118 employees of a hospital were recruited from 2010 to 2011. The raised parameters were satisfaction with the program, work ability (Work Ability Index), and sickness absence (provided by human resource management). Patient-reported questionnaire data was raised at baseline (t1) and after three months (t2). Sickness leave was evaluated in the period six months prior to and six months after the intervention. Means, frequencies, standardized effect sizes (SES), analysis of variance, and regression analysis were carried out. Participants were found to be highly satisfied. Work ability increased with moderate effects (SES = 0.34; p < 0.001) and prognosis of gainful employment (SES = -0.19; p ≤ 0.047) with small effects. Days of MSD-related sickness absence were reduced by 38.5% after six months. The worksite intervention program is transferable to a hospital setting and integration in occupational health management is recommended. The use of a control group is necessary to demonstrate the effectiveness.