Gabriele Lindena

Validation of the German version of the Brief Pain Inventory.

The Brief Pain Inventory is a comprehensive instrument for pain assessment and has been validated in several languages. A validated German version was not available until now. From March to May 1995 all outpatients of the pain clinic of the Department of Anesthesiology completed a questionnaire with the German versions of the Brief Pain Inventory (BPI) and the SF-36 quality-of-life questionnaire. The BPI was repeated after the consultation. The physician assessed the performance status score of the Eastern Cooperative Oncology Group (ECOG). The questionnaire was completed by 151 patients. Forty-two patients were excluded from evaluation for methodological reasons, so 109 patients were evaluated. As in the original version of the BPI, factor analysis showed a common factor for pain intensity and a second factor for pain-related interference with function. The comparative fit index of 0.86 confirmed this model. Responses before and after consultation correlated closely for the sum scores of the pain intensity items (Perarson correlation r = 0.976) as well as for the interference with function items (r = 0.974). Pain intensity in the BPI correlated with bodily pain in the SF-36 (r = 0.585). Sum scores of the pain interference items were higher in patients with deteriorated ECOG performance status, whereas sum scores of the intensity items were not changed. Validity and reliability of the German BPI were comparable to the original version. The BPI may be advantageous for palliative care patients, as it places only a small burden on the patient and offers easy criteria for evaluation. However, further research is needed to differentiate the impact of pain-related and disease-related interference with function on the BPI, and to find an algorithm for the evaluation of the BPI when values are missing.

Drugs in palliative care: results from a representative survey in Germany

The development of palliative medicine in inpatient units in Germany has been impressive in the last years. As a first step of quality assurance, a core documentation form was developed in 1996. In 2001, 55 of the 83 palliative inpatient units in Germany and one unit each in Switzerland and Austria participated in the third phase of the evaluation of the core documentation. A total of 1304 patients were documented consecutively in the 57 units for a period of up to three months. This study investigates the frequency of drugs used in palliative care units in Germany. During inpatient treatment, the most common drug classes were strong opioids (68% of the patients), nonopioids (59%), corticosteroids (32%), laxatives (31%), antiemetics (27%), gastric protection agents (24%), neuroleptics (19%), sedatives/anxiolytics (18%), antidepressants (16%) and diuretics (15%). These ten drug classes made up for 72% of all prescriptions in the palliative care units. The substances used most frequently were dipyrone (47% of the patients), morphine (42%), fentanyl (28%), dexamethasone (27%), metoclopramide (21%), sodium picosulfate (15%), haloperidol (13%), pantoprazole (11%), macrogol (11%), amtriptyline (11%), furosemide (10%), omeprazole (9%), lactulose (8%), rofecoxib (8%) and lorazepam (7%). The 15 most commonly used drugs accounted for 54% of the prescriptions in the palliative care units in Germany. Drug treatment was related to sex, age and functional status of the patients. Patients who died in a palliative care unit had received significantly more frequent doses of neuroleptics (PB / 0.001), corticosteroids (PB / 0.001), sedatives/anxiolytics (PB / 0.001) and strong opioids (PB / 0.001). This study is the first representative and systematic evaluation of drug treatment in palliative care units in a European country. Many of the ’top 15‘ drugs were drugs included in the list of essential drugs of the World Health Organisation though availability and cultural differences have an effect on the use of drugs, e.g., the high usage of dipyrone in Germany. Age and sex-related differences in drug therapy were seen, and more research is needed to recognize possible undertreatment of symptoms in subgroups of patients, e.g., treatment of depression in older or male patients.

What are the problems in palliative care? Results from a representative survey.

The development of a standardised core documentation for palliative care was initiated in Germany in 1996. Results from previous evaluations have shown the wide variability of the documentation in participating units. A different documentation form was used in 2001 using free text entries to find out what problems palliative care specialists perceive in their patients. Fifty-five of the 83 palliative inpatient units in Germany (66% of the units) as well as one unit each from Austria and Switzerland, documented 1,304 patients in the core documentation in 2001. Inpatient care was continued until death for 531 patients, 604 patients were discharged home and 169 patients were transferred to other places of care. Palliative care treatment effectively reduced mean physical symptom intensity. Mean intensities of psychological and social problems also were reduced although not as much as physical symptom load. Nursing problems were reduced for those patients discharged but not for those who died in the unit. Anxiety and depression were the most frequent psychological problems. Nursing problems were focussed on impairment of mobility and other activities of daily living such as washing, nutrition and drinking. Excessive distress on caregivers and the organisation of home care were the predominant social problems. In conclusion, this representative prospective survey with the majority of palliative care units in Germany showed the high effectiveness of symptom relief. Using the categories identified in this study, checklists were constructed and included in the documentation forms that are currently used for the core documentation project.

What Is Palliative Care in Germany? Results from a Representative Survey

The recent development of palliative care inpatient units in Germany has been impressive. As a first step for quality assurance, a core documentation form was developed in 1996. The core documentation form consisted of 4 pages with 35 items documenting physical and psychosocial symptoms at the time of admission, diagnostic and therapeutic procedures before and during inpatient treatment, and outcome of physical and psychosocial dimensions. Checklists were used for most items and free text entries could be added. Of the 65 palliative inpatient units in Germany, 44 participated in the second phase of the evaluation of the core documentation in 2000. Eight units were affiliated with anesthesiology departments, 31 with internal medicine, two with radiotherapy, 1 with a surgical department, and 2 units were not affiliated with a department of the hospital. A total of 1087 patients were assessed in the 44 units during a period of up to 3 months. There was a high variability between units in all checklist items of the core documentation. Compared to units affiliated with internal medicine departments, units affiliated with anesthesiology departments performed less chemotherapy, but more immunotherapy; gave fewer infusions and blood transfusions but more skin and wound care, and more lymphatic drainage and massage; and documented psychosocial interventions more frequently for patients as well as for relatives. In one-third of the patients, a consent for omission of therapeutic options was documented. Inpatient treatment ended with the death of the patient in 45.3% of patients and with discharge in 51.6% (not documented 3.1%). The efficacy of inpatient treatment was rated very high by the staff. In conclusion, we found large variation in the documentation pertaining to palliative care patients at the time of admission, as well as for inpatient treatment, among palliative care units in Germany. This was related to the affiliation of the units at least to some degree, but also to differences in interests and documentation discipline. We suggest that training procedures for documentation should be included in crossectional surveys, as the results may not be comparable otherwise. However, common documentation instruments may be the first step towards an interdisciplinary discussion on aims and methods in palliative care.

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.

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.

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

BackgroundPatients 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.MethodWith 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.Results286 (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.ConclusionThe 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.

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.

Intravenous titration with morphine for severe cancer pain: report of 28 cases.

BACKGROUND In a multicenter study, 28 patients with cancer pain and insufficient pain relief with analgesic treatment according to step II of the guidelines of the World Health Organization (WHO) were switched to oral slow-release morphine. METHODS Patients received intravenous morphine through a patient-controlled pump (PCA) for the first 24 hours (bolus = 1 mg, lockout interval = 5 minutes, maximum dose = 12 mg/hour). From day 2 patients were treated with oral slow-release morphine. Daily doses were calculated from the requirements of the day before. Breakthrough pain was treated with PCA until stable doses were reached (<2 boluses/day) and then with oral immediate-release morphine solution. Pain intensity was reported in a diary four times a day, in addition to mood, activity, and quality of sleep once daily. RESULTS Mean duration until adequate pain relief reported (<30 on a 101-step numerical scale; NRS) was 5 hours (range = 80-620 minutes). Mean pain intensity was reduced from 67 NRS to 22 NRS. Mean doses of oral morphine were 133 mg/day initially and then 154 mg/day on day 14. Serious adverse events such as respiratory depression were not observed. Two patients terminated the study due to progressive symptoms of gastrointestinal obstruction. Seventy-five percent of the patients evaluated the effectiveness of the analgesic regime as good. CONCLUSIONS Dose finding with intravenous PCA may be appropriate for a small minority of patients with severe pain. Higher treatment costs and the risk of complications are drawbacks of this method compared with conventional oral titration.

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.