PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany.

BACKGROUND: Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients with recurrent pain and at risk of developing chronic pain. This project was initiated by the German Pain Society (Deutsche Schmerzgesellschaft e.V.) and the public health insurance provider BARMER. It is currently funded by the German Innovation Fund (01NVF20023). The study PAIN2.0 focuses on reducing pain intensity and pain-related disability and investigates whether this intervention can improve physical activity, psychological well-being, and health literacy. METHODS: PAIN2.0 is designed as a multicentre 1:1 randomised controlled trial with two parallel groups (randomisation at the patient level, planned N = 1094, duration of study participation 12 months, implemented by 22 health care facilities nationwide). After 6 months, patients within the control group also receive the intervention. The primary outcomes are pain intensity and pain-related impairment, measured as Characteristic Pain Intensity (PI) and Disability Score (DS) (Von Korff), as well as patient-related satisfaction with the intervention. Secondary outcomes are the number of sick leave days, sickness allowance, treatment costs, psychological distress, health-related quality of life, and catastrophizing. The effects of the intervention will be analysed by a parallel-group comparison between the intervention and control groups. In addition, the long-term effects within the intervention group will be observed and a pre-post comparison of the control group before and after the intervention will be performed. DISCUSSION: Recurrent or persistent pain is common in the German population and causes high costs for patients and society. The A-IMPT aims to improve pain and pain-related impairments in pain patients at risk of chronification, thereby reducing the risk of developing chronic pain with its high socioeconomic burden. This new therapy could easily be integrated into existing therapy programs if positively evaluated. TRIAL REGISTRATION: The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773 .

[Development of two outpatient interdisciplinary group modules in the treatment of patients with pain and risk of chronification]. / Entwicklung zweier ambulanter gruppentherapeutischer interdisziplinärer Therapiemodule in der Behandlung von Patienten mit Schmerzen und Chronifizierungsrisiko.

BACKGROUND AND OBJECTIVE: An early treatment of patients who suffer from pain and show risk factors for chronification is meaningful as these patients can benefit from an early interdisciplinary multimodal pain treatment (IMST). In view of the insufficient treatment, two outpatient treatment modules for the secondary prevention of pain chronification are developed within the framework of PAIN2020: the educative and accompanying IMST (E­IMST and B­IMST). MATERIAL AND METHODS: The developmental process of both IMSTs is presented. In this context two target groups of patients were defined for which 1 session (E­IMST) or 10 intervention appointments (B­IMST) were planned, depending on the chronification, impairment and complexity of the disorder. The conception was carried out in five steps: development of the objectives, development of the main contents, workshop on the content and conceptional design (contents, mediation, exercises), preparation of a time schedule and processing of the results (manual, presentations, worksheets, handbook). The B­IMST was initially developed from which the contents for the E­IMST were subsequently extracted. Additionally, a concept for testing the feasibility and a working model for a pilot study were developed. RESULTS: The objectives for both forms of IMST are improvement of the understanding of pain and contributing factors, the increase of the experience of control and self-efficacy and the increase in self-responsibility with respect to strategies to reduce pain. Differences between the two treatment modules arise from the needs and framework conditions. Medical, physiotherapeutic and psychotherapeutic contents and schedules were organized for both IMST modules. The B­IMST consists of five modules each with two sessions as group interventions (biopsychosocial model, activation planning, regulation of needs, sleep and medication, routine transfer). The 3­h E­IMST group intervention mainly intends to mediate knowledge on pain and the biopsychosocial pain model. Theoretical and practical interventions, empirical knowledge and experience-oriented methods are employed. CONCLUSION: There are now two interdisciplinary structured manuals for the secondary preventive treatment of patients with recurrent pain and a risk profile for chronification. These approaches must now prove themselves with respect to feasibility and effectiveness.

[Second opinion on spine surgery : Indication rarely confirmed and conservative treatment options are worthwhile]. / Zweitmeinung vor Operationen an der Wirbelsäule : Selten bestätigt, aber alternative Therapieangebote sind sinnvoll.

BACKGROUND: Second opinion (SO) on spine surgery was recently implemented as a statutory right in Germany. Prior to this, one health insurer did offer SO to its policy holders including advice on additional conservative treatment options. OBJECTIVES: Which treatment recommendations did 522 patients receive in an interdisciplinary multimodal assessment (IMA) as part of a SO by 4 teams comprising physician, physio- and psychotherapist and what were the long-term consequences? METHODS: Second opinions under a selective contract between insurer and back pain centers were evaluated based on patient-related anamnesis and interdisciplinary multimodal clinical findings including treatment recommendations and patient reports after about 2 years. RESULTS: Initially, spine surgery recommendation was confirmed in 15/522 (2.9%) patients (C-SS) versus 507 recommendations against. C­SS patients were older, male, and had current high pain intensity more frequently, their well-being and quality of life were more often considerably impaired and from the perspective of the team morphological findings were stronger. Younger and female patients with higher pain grade and less previous surgery, but more visits to medical specialties received more often a recommendation of an interdisciplinary treatment option (ITO) versus standard care (SC). After 2 years, all 15 C-SS patients and 146 randomly selected patients were contacted. Of these 161 patients, 29 (18%) had undergone spine surgery. The long-term outcome was best in ITO patients without surgery, followed by the C­SS after surgery and SC patients without surgery. DISCUSSION: Most patients undergoing spine surgery make their decision based on the information that they are provided without requesting a SO. As in comparative studies, most patients with a confirmed surgical indication underwent surgery, while some did not. Some patients underwent surgery inspite of recommendations against-after considering conservative therapy recommendations by the IMA. In retrospect, sound advice and an intensive conservative therapy offer seem necessary and reasonable.

[Less surgery and lower cost due to back pain in a care program with an interdisciplinary second opinion procedure : A controlled non-randomized intervention study based on claims data]. / Weniger Operationen und Kosten wegen Rückenschmerzen in einem Versorgungsprogramm mit interdisziplinärem Zweitmeinungsverfahren : Eine kontrollierte, nichtrandomisierte Interventionsstudie mit GKV-Daten.

BACKGROUND: There is no evidence of effectiveness for interdisciplinary second opinion procedures (ISOP) for recommended back surgery (BS). Since 2015, AOK Nordost has been offering the care program RückenSPEZIAL comprising a preliminary examination, ISOP, and optional interdisciplinary multimodal pain therapy (IMPT). The objective of this study is to determine the effectiveness of RückenSPEZIAL to reduce BS and back pain-related costs (BPRC) compared to patients who likewise received a recommendation for back surgery but not RückenSPEZIAL. METHODS: Insured persons in the AOK Nordost consulted the AOK service center, presented a BS hospital admission slip and received advice to participate in RückenSPEZIAL. Following a 1:1 "matched pairs" selection, patients who participated in RückenSPEZIAL (intervention group [IG]) after this consultation (reference date) where compared with patients who did not participate after this consultation (comparison group [CG]). Patient characteristics, BS and BPRC were operationalised from AOK Nordost claims data. RESULTS: Of 108 IG patients and 108 CG patients, 34 (42%) fewer IG patients had one or more BS in 365 following days (relative risk [RR] 0.58; p < 0.001). The subgroup analysis showed for 21 IG patients with ISOP and IMPT an RR of 0.13 (p < 0.001), and for 67 IG patients with solely ISOP without IMPT an RR of 0.59 (p < 0.001). The increase in RBC from the previous year to the following year was 50.2 percentage points lower for IG patients compared to CG patients (p = 0.088). DISCUSSION: The differences in BS were significant (p < 0.05) and in favor of RückenSPEZIAL. For the specific population it can be expected that mainly savings on BS can cover the intervention costs of RückenSPEZIAL (approximately significant, small case number). Bias due to self-selection needs to be assumed.

[Prevention of chronic pain in the German healthcare system : Current state and perspective]. / Vermeidung chronischer Schmerzen in der deutschen Gesundheitsversorgung : Derzeitiger Stand und Ausblick.

The current healthcare provision in Germany is established, in particular, for the diagnostics and treatment of chronic pain conditions; however, the current aim is to initiate the diagnostic and therapeutic approaches oriented towards the biopsychosocial pain model in the early stages of pain, i.e. before the onset of chronification, for patients with pain and a risk of chronification in order to actively avoid chronification processes. In this context, multiple risk factors play an important role for the diagnostic and therapeutic approaches as well as for the interdisciplinary multimodal pain therapy developed for this purpose. The Global Year of the International Association for the Study of Pain (IASP) 2020 addressed the prevention of (chronic) pain, a welcome opportunity to provide a short review of the evidence for and clinical experiences with timely diagnostic and therapeutic options and to summarize the current framework conditions and scientific recommendations for Germany. At the end of this article the implications for future research are summarized, particularly for the treatment of patients with pain and risk of chronification.

[Evaluation of an early interdisciplinary multimodal assessment for patients with pain : Protocol of a randomized controlled study (PAIN2020)]. / Evaluation eines frühen interdisziplinären multimodalen Assessments für Patienten mit Schmerzen : Protokoll einer randomisierten kontrollierten Studie (PAIN2020).

Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches. The PAIN2020 project is funded by the German Federal Ministry of Health Care (Innovationsfonds 01NVF17049) and aims to improve health care delivery for this group of patients by implementing an early ambulatory diagnostic approach by a pain specialist, resulting in an improvement in pain and restored or maintained function. A randomized clinical trial in 31 facilities Germany-wide will identify eligible patients and guide them into early specialized pain diagnostics. The interventional arm provides an interdisciplinary multimodal assessment, delivered by pain medicine specialists, physiotherapists and clinical psychologists. The control arm contains a single assessment by a pain specialist. Patients and caregivers receive detailed recommendations for evidence-based interventions tailored to the needs of the individual patient. Two evaluation approaches will be merged. The first requires a net sample size of 3840 patients, assessed (admission) and followed-up (3 and 6 months) by clinical data (German Pain Questionnaire, additional scales) and analyzed by a multi-level approach. In a second evaluation arm the clinical data of the included patients will be supplemented by secondary data from a statutory health insurance (BARMER) and compared to a sample of policyholders not addressed by the study. Data analyses will be performed by an external evaluation institute. The project started in April 2018.

[Early Interdisciplinary Assessment for Secondary Prevention of Chronic Pain - Scientific Background, Concept of Delivery, Target Population and Status of Health Care Provision]. / Frühes interdisziplinäres Assessment zur Sekundärprävention chronischer Schmerzen.

Pain is agreed to be understood as a multi-causal, biopsychosocial phenomenon. A sufficient health care delivery shall therefore contain a corresponding interdisciplinary approach in diagnostic and therapy, respectively. Factors contributing to the process of chronification should be considered early in treating patients suffering from recurrent or persistent pain. Close collaboration of multidisciplinary protagonists in health care as well as interdisciplinary comprehensive medical treatment offer are two of the prerequisites for good practice in health care treating patients with pain.The article introduces into existing knowlegde about pain and risk factors for chronicity. The background (evidence and theoretical) of corresponding health care approaches and a detailed concept of interdisciplinary pain diagnostic by a multiprofessional team consisting of pain physician, physiotherapist and clinical psychologist are described and discussed.

[Effectiveness of a risk-tailored short intervention to prevent chronic low back pain : A cluster-randomized study in general practice]. / Effekte einer risikoadaptierten Kurzintervention zur Prävention der Chronifizierung bei akuten Rückenschmerzen : Eine clusterrandomisierte Studie in Hausarztpraxen.

BACKGROUND: A subgroup of patients with acute low back pain (LBP) will develop chronic LBP. Risk factors summarized as yellow flags are fear-avoidance beliefs, depression, catastrophizing, and work-related problems. OBJECTIVE: The aim was to evaluate the effectiveness of screening for yellow flags in general practice followed by a risk-tailored group intervention compared to care as usual. METHODS: This is a cluster-randomized controlled trial in 35 general practices with 354 patients with acute LBP. Information or a standardized group intervention was offered to patients in the intervention group according to the screening algorithm with a short questionnaire for physical and psychosocial risk factors for chronic LBP. Standardized group information contained education concerning back pain and strategies for physical activities and planning of actions. Primary outcome was functional capacity assessed after 6 and 12 months with a questionnaire. Secondary outcomes were pain severity, fear avoidance beliefs, depression score, self-rated health and health service utilization. RESULTS: The intervention had no clinically relevant effect on the primary outcome functional capacity and secondary outcomes, although the course was consistently slightly better. Adherence to the offered intervention was low. Health service utilization was not altered to a relevant extent. A subgroup analysis comparing adherent and non-adherent patients showed a consistently better course of adherent patients. CONCLUSIONS: A risk-tailored short intervention to prevent chronic LBP in general practice had no significant impact on the clinical course compared to care as usual. A subgroup analysis comparing adherent and non-adherent patients suggests that it is possible to have a positive impact on patient-relevant outcomes.

Mobile Palliative Care Consultation Service (PCCS): Overview of Hospice and Palliative Care Evaluation (HOPE) Data on In-Patients With End-Stage Cancer, Multiple Sclerosis, and Noncancer, Nonneurological Disease From 4 PCCS Centers in Germany in 2013.

CONTEXT: During the last decade, numerous in-patient Palliative Care Consultation Service (PCCS) units were established throughout Germany. OBJECTIVE: To provide an epidemiological overview on a whole year cohort of palliative patients in terms of demography, complaints, and therapy on admission to PCCS and the impact of PCCS treatment, and identify differences and similarities in different palliative patient subgroups. METHODS: Chi-square, analysis of variance (ANOVA), Kruskal-Wallis followed by Games-Howell analysis of HOspice and Palliative care Evaluation (HOPE 2013) data on 4 PCCS centers and in total 919 patients, with solid tumors (237), metastatic cancer (397), leukemia and lymphoma (99), neurological (109, mostly multiple sclerosis [MS]), and noncancer, nonneurological disease (NCNND, 77). RESULTS: A mostly uniform block of 3 cancer subgroups in terms of demographics, admission complaints, and initial pharmacological treatment diverged from the neurologic/MS disease subgroup. The "intermediate," NCNND subgroup coalesced with the cancer or the neurologic/MS subgroups in part of the demographics, complaint, and drug parameters. Tetraparesis, requirement for nursing, and help with daily living were more, and pain, dyspnea, weakness, appetite loss, and fatigue were less frequent in neurologic patients compared with the cancer subgroups. Neurologic patients also showed more common use of coanalgetics and antidepressives, less opiates and nonopiate analgetics, corticosteroids, and antiemetics and antacids. NCNND patients had a particularly high rate of disorientation (48%) and death during PCCS (39%). In the 3 cancer subgroups, dyspnea, weakness, appetite loss, and anxiolytic use were less frequent in solid tumor patients. Palliative Care Consultation Service treatment was associated with reduction in symptom severity independent of subgroup entity. All listed differences were significant at P < .05 level. CONCLUSION: Despite divergence in demographics, symptoms, and medication, the data underline general usefulness of PCCS care in all end-stage patients and not only the cancer subgroups. Nevertheless, the strong differences revealed in the current study also underscore the need for a carefully tuned, disease-specific therapeutic approach to these subgroups of palliative patients.

Patients in palliative care-Development of a predictive model for anxiety using routine data.

INTRODUCTION: Anxiety is one of the most common psychological symptoms in patients in a palliative care situation. This study aims to develop a predictive model for anxiety using data from the standard documentation routine. METHODS: Data sets of palliative care patients collected by the German quality management benchmarking system called Hospice and Palliative Care Evaluation (HOPE) from 2007 to 2011 were randomly divided into a training set containing two-thirds of the data and a test set with the remaining one-third. We dichotomized anxiety levels, proxy rated by medical staff using the validated HOPE Symptom and Problem Checklist, into two groups with no or mild anxiety versus moderate or severe anxiety. Using the training set, a multivariable logistic regression model was developed by backward stepwise selection. Predictive accuracy was evaluated by the area under the receiver operating characteristic curve (AUC) based on the test set. RESULTS: An analysis of 9924 data sets suggests a predictive model for anxiety in patients receiving palliative care which contains gender, age, ECOG, living situation, pain, nausea, dyspnea, loss of appetite, tiredness, need for assistance with activities of daily living, problems with organization of care, medication with sedatives/anxiolytics, antidepressants, antihypertensive drugs, laxatives, and antibiotics. It results in a fair predictive value (AUC = 0.72). CONCLUSIONS: Routinely collected data providing individual-, disease- and therapy-related information contain valuable information that is useful for the prediction of anxiety risks in patients receiving palliative care. These findings could thus be advantageous for providing appropriate support for patients in palliative care settings and should receive special attention in future research.

Is breathlessness what the professional says it is? Analysis of patient and professionals' assessments from a German nationwide register.

PURPOSE: Breathlessness is a common and distressing symptom in patients with advanced disease. Patients' self-report is deemed to be the most valid method of symptom assessment. When patients are not capable of self-assessment, professionals' assessment is often used as alternative but evidence on the validity is conflicting. The aim of this study was to compare self- and professionals' assessment of breathlessness regarding presence and severity in patients with advanced disease. METHODS: Secondary analysis of a cross-sectional, multi-centre and nationwide register (HOspice and Palliative Care Evaluation (HOPE)). Documented inpatients from hospices and palliative care units from 2006 to 2008 who completed the self-assessed MInimal DOcumentation System (MIDOS) were included. Professionals' assessment were based on the integrated symptom and problem checklist (symptom scores, 0-3). Cohen's kappa (κ) was used to estimate the 'level of agreement' (LoA). RESULTS: Two thousand six hundred twenty-three patients (mean age, 66.9 (SD, 12.8); 54.4% female; median Eastern Cooperative Oncology Group score, 3; 95.9% with malignant disease) were analysed. Prevalence of breathlessness was 53.4% (1,398 patients) by professionals' and 53.1% (1,410 patients) by self-assessment. Presence was correctly evaluated by professionals in 80.9% of cases (sensitivity, 81.8%; specificity, 79.8%). Severity of breathlessness was correctly estimated in 65.7% of cases. LoA was good (κ=0.62) for the evaluation of presence of breathlessness and moderate (κ=0.5) for the estimation of severity. The proportion of over- or underestimated scores was similar. CONCLUSIONS: If patient's self-rating, the gold standard of symptom assessment, is not possible, professionals' assessment might be a valid alternative, at least for assessing the presence of breathlessness.

Symptoms and problem clusters in cancer and non-cancer patients in specialized palliative care-is there a difference?

CONTEXT: In clinical practice, some symptoms and problems frequently occur in combination, which may have consequences for symptom management. OBJECTIVES: Facing a growing number of non-cancer patients in palliative care, this study aimed to differentiate symptom clusters in the non-cancer population from those in cancer patients. METHODS: Inpatient data from the German Hospice and Palliative Care Evaluation between 2007 and 2011 were used for a cluster analysis of a 16-item symptom and problem checklist. An agglomerative hierarchical method was chosen. Coefficients from distance matrix ranging between 0 and 1 were calculated to indicate the interrelationship of clustered symptoms. RESULTS: The analysis identified five clusters in cancer patients: 1) nausea and vomiting (d = 0.000); 2) anxiety, tension, and feeling depressed (d = 0.125); 3) wound care and disorientation/confusion (d = 0.229); 4) organization of care and overburdening of family (d = 0.202); and 5) weakness, tiredness, need for assistance with activities of daily living, and loss of appetite (d = 0.207). Five comparable clusters were identified in non-cancer patients: 1) nausea and vomiting (d = 0.000); 2) anxiety, tension, and feeling depressed (d = 0.166); 3) organization of care and overburdening of family (d = 0.187); 4) weakness and need for assistance with activities of daily living (d = 0.139); and 5) tiredness and loss of appetite (d = 0.182). CONCLUSION: As symptom clusters do not significantly differ between cancer and non-cancer patients, specific frequent symptoms in non-cancer patients should be assessed. Identification of symptom clusters may help to target therapies and focus the use of medications to improve patients' quality of life.

Trends in specialized palliative care for non-cancer patients in Germany--data from the national hospice and palliative care evaluation (HOPE).

INTRODUCTION: The proportion of non-cancer patients (NCs) admitted to palliative care (PC) services increases steadily. Nevertheless, little is known not only about their specific problems, needs that have to be met, but also about improvements that have taken place already. This analysis focuses on developments seen in NC management concerning end-of-life care. METHODS: The German Hospice and Palliative Care Evaluation (HOPE) is a national long-term quality assurance project providing information on PC patients. Data from yearly evaluation periods between 2007 and 2011 are used to investigate differences between NC patients documented from 2002 to 2005 in symptoms, treatment and general condition. RESULTS: The proportion of NC patients increased from 3.5% (147/4182) to 8.1% (558/6854). NC patients, which are now referred to PC services, are younger, show less need for nursing support, die less often during inpatient stay. Overall a greater variety of diagnoses were found and patients suffer from less complex symptoms and problems at admission. CONCLUSIONS: Despite the continuously growing number of patients with non-malignant diseases, their number in PC services is still low. As small steps in the right direction have been taken, integrating PC ideas earlier into treatment of chronic diseases to improve quality of life of NCs during the final stages of their diseases will continue to challenge the health care system in terms of workload, need of more staff and further training of medical professionals dealing with NCs in the future.

What is special about patients with lung cancer and pulmonary metastases in palliative care? Results from a nationwide survey.

BACKGROUND: Patients with advanced lung cancer constitute a special focus in palliative care not only for epidemiological or prognostic reasons, but also because their symptom burden is felt to be widespread and difficult to treat. This study describes disease-specific characteristics and the symptom burden of patients with advanced incurable lung cancer, comparing them with patients suffering from other diseaseentities. METHODS: A secondary analysis of the nationwide Hospice and Palliative Care Evaluation (HOPE) was performed, by focussing on inpatient hospice and palliative care unit patients and by using descriptive methods. RESULTS: From 2006 to 2008, 5487 inpatients were registered, 874 of which were diagnosed with lung cancer and 1884 with pulmonary metastases. Symptoms such as weakness, tiredness, or pain were most prevalent in all subgroups. Dyspnea was significantly more prevalent in all patients with different kinds of pulmonary tumor manifestations; confusion was significantly more prevalent in patients with lung cancer. Dyspnea could not be treated as effectively as pain or nausea. Confusion and nursing problems worsened during the observation period. Dyspnea and confusion were associated with increased risk of death during the observational period. CONCLUSION: The symptom pattern of patients with lung cancer is characterized by dyspnea and confusion--symptoms that are difficult to treat until discharge and that imply a worse prognosis. Therefore, increased research on the pathophysiology and treatment of dyspnea and confusion is required, and efforts in advance care planning and anticipation of dyspnea and confusion as a critical symptom in patients with lung cancer should be reinforced.

Palliative sedation in Germany: how much do we know? A prospective survey.

BACKGROUND: Little is known about the practice of palliative sedation (PS) in Germany. This paper presents an analysis of sedation-related data obtained from the German standardized core documentation system (HOPE) for palliative care patients. METHODS: HOPE was complemented by an optional module on ethical decision making (EDM) which was pretested in 2004, data was collected in 2005-6 during the annual 3-month census. Data was analyzed descriptively from palliative care units (PCU - representative) and inpatient hospice (H - non-representative control group). Chi(2) test was used to test for differences between the reported data per item and year within one kind of setting (significance level p ≤ 0.05). Free-text entries were categorized inductively. RESULTS: Datasets were obtained for 1,944 patients (P) with EDM. PS was performed in 13.0/11.8% (2005/2006) P in palliative care units (PCU) and 25.5/22.9% in hospices (H). Main reasons for PS in PCU were dyspnea, pain, fear or anxiety, in H reasons were inconsistent, high prevalence of psychosocial reasons. Most PS in PCU and about half of the PS in H were intermittent. Sedated P were younger than non-sedated. Only 7 P received PS after asking for euthanasia. The most used medication was midazolam. CONCLUSIONS: This study reveals a first insight into the use and practice of PS in German PCU and H. For a more detailed systematic survey into the course of decision-making and procedures, a new complementary optional module on PS is being developed by the HOPE group.

Antibiotics in palliative medicine--results from a prospective epidemiological investigation from the HOPE survey.

BACKGROUND: Patients with advanced cancer are highly susceptible to infections. The decision whether to treat an active or suspected infection or to withhold or withdraw an antibiotic treatment in end-of-life care may be difficult. In order to quantify the antimicrobial prescribing practices and decision-making processes in palliative care units in Germany, a survey was performed as part of the Hospice and Palliative Evaluation in 2006. METHOD: With a specifically designed questionnaire, 448 patients for whom an active or suspected infection and antibiotic treatment was discussed were documented. Data on the use of and indication for antibiotic treatment and the decision-making on withdrawal or withholding of antibiotic therapy were collected. RESULTS: 286 (63.8%) received an antibiotic therapy. In 88 cases, withdrawal of an ongoing treatment was documented. The most frequent reasons for withdrawal were: deterioration of general status (41.4%), inefficiency of therapy (25.7%), and explicit wish of patient (14.3%; multiple answers possible). Outcome of antimicrobial therapy was rated poor or very poor for a fifth of the cases and accordingly, antibiotics were more likely to be withdrawn if the clinical success was considered to be poor. The initiation of therapy was often decided by physicians solely, whereas withdrawing and withholding therapy demanded more often involvement of other team members in the decision-making process. CONCLUSION: The initiation of therapy seems to be easier than withdrawing and withholding, as involvement of other team members in the decision-making process was then sought more often. When antibiotics were given until death, the indication should be reconsidered because of a possibly undesirable prolongation of the dying process. Clinical practice may benefit from clear definitions of treatment goals and outcome criteria to better evaluate the necessity for and success of antimicrobial treatment.

Validation of the Symptom and Problem Checklist of the German Hospice and Palliative Care Evaluation (HOPE).

CONTEXT: The German Hospice and Palliative Care Evaluation (HOPE) is a national, long-term quality assurance project. Every year, German hospice and palliative care institutions document a core data set for their patients for a period of three months. OBJECTIVES: To validate the multidimensional symptom and problem checklist (HOPE-SP-CL) of the core data set and report details on reliability and validity. METHODS: Data from yearly evaluation periods between 2002 and 2009 were used to calculate construct and convergent validity, internal consistency, test-retest reliability, and documentation discipline and acceptance of the core documentation system. RESULTS: The HOPE-SP-CL includes items on physical, nursing, psychological, and social symptoms and problems. Factor analysis extracted four low to moderately intercorrelating factors with eigenvalues greater than 1.0 explaining 56% of the total variance. Discriminant validity of the HOPE-SP-CL showed good properties in detecting patient groups with different symptom intensities and overall symptom burden using the Eastern Cooperative Oncology Group performance status and primary cancer diagnosis as external validation criteria. The global sum score of the HOPE-SP-CL correlated most closely with the Palliative Outcome Scale staff version (r=0.750). Internal consistencies ranged between α=0.768-0.801 at three different times of assessment. Test-retest coefficients showed moderate to high correlations at one-week intervals. CONCLUSION: Analyses of reliability and validity of the HOPE-SP-CL showed satisfactory to good psychometric properties; therefore, the HOPE-SP-CL can be recommended for standard implementation in German hospice and palliative care institutions.

Assessment of distress with physical and psychological symptoms of patients in german palliative care services.

BACKGROUND: Within the framework of the nationwide Hospice and Palliative Care Evaluation (HOPE), the German Basic Documentation for Psycho-oncology (PO-Bado) was used from 2004 to 2006 as an optional module in most participating palliative care services to investigate how patient distress due to symptom burdens in different palliative care settings should be assessed and how professional interventions could be derived. PATIENTS AND METHODS: The distress scores of 3,317 PO-Bado records out of a total of 6,958 consecutive participants from 3 yearly samples of HOPE were evaluated descriptively and compared with a reference sample of cancer patients from both general and university hospitals. RESULTS: The relative values of distress from physical and psychological symptoms were 0.57 and 0.37 (maximum of 1.0), respectively. In 38.2% of the patients, professional psychosocial interventions were indicated. Compared to the reference sample of cancer patients, palliative care patients clearly showed more specific physical distress, but psychological symptoms were varied; in particular, distress from cognitive impairment, helplessness and grief showed higher intensities in palliative care patients than in the reference group. CONCLUSIONS: The PO-Bado rating scales assessed high levels of distress, particularly from physical symptoms, in palliative care patients. A large percentage of palliative care patients required professional psychosocial support.

Non-cancer patients in specialized palliative care in Germany: what are the problems?

To determine the role of non-cancer palliative care in inpatient services in Germany, data from the Hospice and Palliative Care Evaluation (HOPE) were analysed. Since 1999, a three-month census has been conducted annually in German palliative care units. Pooled data from 2002-2005 were tested for differences between non-cancer patients (NCs) and cancer patients (Cs). A total of 4182 patients (NC: 3.5%; C: 96.5%) were documented; functional status (using Eastern Cooperative Oncology Group (ECOG) measures) in NCs was lower compared to Cs (p = 0.009). NCs suffered more often from dyspnoea (40%; C: 29%; p = 0.004), weakness (92,3%; C: 84,5%; p = 0.011) and tiredness (75.4%; C: 66.7%; p = 0.03) and less from nausea (17.1%; C: 28.9%; p = 0.002), vomiting (8.2%; C: 19.4%; p = 0.001) or loss of appetite (55.5%; C: 67.9%; p = 0.002). There were no differences in pain and constipation. Other problems (nursing, psychological) were more frequent for NCs, in particular the need for support in the activities of daily life (90.3%; C: 72.8%; p < 0.001) and disorientation/confusion (32.1%; C: 17.2%; p < 0.001). There were no differences in social problems. NCs are still rare in specialized inpatient palliative care institutions in Germany. The palliative care needs in patients with non-malignant disease will challenge the health care system as the workload for these services will grow over proportionally.

Assessing a risk tailored intervention to prevent disabling low back pain--protocol of a cluster randomized controlled trial.

BACKGROUND: Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. METHODS/DESIGN: This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. DISCUSSION: This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. TRIAL REGISTRATION: ISRCTN 68205910.