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Biomedical subjects

Lukas Radbruch

Publications and source records attributed to Lukas Radbruch.

At least 19 recordsLinked to original sources

Pain assessment tools: is the content appropriate for use in palliative care?

Inadequate pain assessment prevents optimal treatment in palliative care. The content of pain assessment tools might limit their usefulness for proper pain assessment, but data on the content validity of the tools are scarce. The objective of this study was to examine the content of the existing pain assessment tools, and to evaluate the appropriateness of different dimensions and items for pain assessment in palliative care. A systematic search was performed to find pain assessment tools for patients with advanced cancer who were receiving palliative care. An ad hoc search with broader search criteria supplemented the systematic search. The items of the identified tools were allocated to appropriate dimensions. This was reviewed by an international panel of experts, who also evaluated the relevance of the different dimensions for pain assessment in palliative care. The systematic literature search generated 16 assessment tools while the ad hoc search generated 64. Ten pain dimensions containing 1,011 pain items were identified by the experts. The experts ranked intensity, temporal pattern, treatment and exacerbating/relieving factors, location, and interference with health-related quality of life as the most important dimensions. None of the assessment tools covered these dimensions satisfactorily. Most items were related to interference (231) and intensity (138). Temporal pattern (which includes breakthrough pain), ranked as the second most important dimension, was covered by 29 items only. Many tools include dimensions and items of limited relevance for patients with advanced cancer. This might reduce compliance and threaten the validity of the assessment. New tools should reflect the clinical relevance of different dimensions and be user-friendly.

Humans↗

Validation and clinical application of the german version of the palliative care outcome scale.

The Palliative Care Outcome Scale (POS) is a multidimensional instrument covering physical, psychosocial, spiritual, organizational, and practical concerns. This study validated the German version of the POS and used the tool in different palliative care settings in Germany and Austria. Patients and staff were asked to complete the POS three times and evaluate the questionnaire and the translation afterwards. One hundred eighteen patients (44 male, 74 female, mean age 63 years, all suffering from advanced cancer) completed the POS one time, 55 patients two times, and 36 patients three times. Spearman's rho was highly significant for pain, other symptoms, anxiety, and life worthwhile in the first two assessments. The third assessment showed significant correlations for pain, other symptoms, anxiety, and family anxiety. Seventy-seven of 87 patients answered questions regarding the scale and the translation. All questions other than "Over the past 3 days, have you felt good about yourself?" were understandable for patients. Almost half of the staff was undecided whether the tool was reflecting the patients' condition. In contrast, the majority of patients liked it. Thus, the German version of the POS is well accepted by patients and staff and appears to be valid, although there are some areas where the scale would benefit from expansion to more closely capture staff and patient concerns.

Austria↗

Emerging analgesics in cancer pain management.

Cancer pain is one of the most frequent symptoms in malignant disease, severely impairing the patients' quality of life. The recommendations of the World Health Organization will provide adequate pain relief for the vast majority of cancer patients. However, some patients will suffer from inadequate analgesia or intolerable side effects. Cyclooxygenase-2 (COX-2)-selective non-steroidal anti-inflammatory drugs (NSAIDs), new anticonvulsants, cannabinoids and NMDA receptor antagonists are being developed for these patients. NSAIDs with nitric oxide-releasing moieties are an interesting addition, as this new class of analgesics combines improved analgesic efficacy with higher tolerability. Conotoxins and other drugs such as nicotinic acetylcholinergic receptor agonists will be advantageous only for a few patients in the near future, as side-effect profile and risk of complications, as well as the burden on the patient, often are not worth the additional analgesic benefit.

Analgesics↗

[Quality assurance in palliative medicine--results of the core documentation of 1999-2002].

Quality assurance has been started in palliative care units since 1999, using a documentation project based on yearly documentation periods. The project was developed by a working party of palliative care specialists in cooperation with the German Cancer Society and the German Association for Palliative Medicine. The aim was a concise but meaningful standard documentation, able to describe the special therapeutic situation of palliative care patients and the interdisciplinary and multi-professional care they receive. In this paper, data of 4693 in-patient treatment periods relating to structural, procedural and outcome quality of palliative care units are presented from the beginning of the core documentation in 1999 through 2001. In 2002, data from palliative care units were compared with those from oncologic and geriatric wards, as well as hospices. Palliative care units show constant traits since the beginning of the core documentation in 1999, in spite of the rising number of participants. At the same time, there are distinct differences among the groups of participants due to the scope of their therapeutic setting. These relate to structure quality in the functional status of the patients (ECOG), which is worst in hospices (> palliative care units > geriatric wards > oncologic wards); to process quality in intensified pain treatment concerning incidence and intensity of pain, which is most frequent and severe in palliative care units (> hospices > geriatric > oncologic wards); and outcome quality in the rate of discharge home, which is highest in oncologic wards (> geriatric > palliative care units > hospices). Quality assurance in palliative care is difficult due to complex indicators, which should be assessed in a standardised documentation. The core documentation was established as a quality assurance programme for palliative care patients. The results of the previous evaluations have enabled the development of a standard documentation. The continuous application of such a standard documentation will prove the quality improvement and development of the participating units.

Documentation↗

Electronic pain diary: a randomized crossover study.

Electronic pain diaries and palm-top computers have become increasingly important in clinical research and practice. In a randomized crossover trial, 24 patients suffering from chronic cancer and non-cancer pain completed both the electronic and the paper version of a pain diary based on the Minimal Documentation System (MIDOS) for pain and symptom assessment. This includes daily assessment of pain on an 11-point numeric rating scale and weekly documentation of a short quality-of-life questionnaire. Of 52 patients seen during the baseline phase of this study, 28 could be enrolled and only 24 patients completed both diary versions. The other patients were either physically or intellectually unable to use a palm-top computer or unwilling to participate in this study. After a total of four weeks, patient satisfaction was remarkably higher for the electronic palm-top version, even though a high number of patients were lacking experience in the use of computers. Obvious differences were observed between the versions. There were higher numbers of missing values in the electronic data, and patients tended to retrospectively fabricate information in the paper version. No significant difference between the electronic and paper diary could be found assessing the documented pain and symptom intensity. The electronic diary was used more frequently and patients said its use supported a more regular pharmacotherapy. We conclude that the use of electronic pain diaries is a valid and feasible method for documenting patients' pain perception, though some patients may not be able to operate such a diary version. Electronic palm-top pain diaries provide a high degree of patient satisfaction and can ease data collection for clinical research and practice.

Adolescent↗

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 (P < 0.001), corticosteroids (P < 0.001), sedatives/anxiolytics (P < 0.001) and strong opioids (P < 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.

Adult↗

Clinical experience with transdermal fentanyl for the treatment of cancer pain in Germany.

The transdermal therapeutic system with fentanyl was released in Germany in 1995. Before and after the release several clinical trials were performed in our pain management unit and in other German pain centers, showing good efficacy after initial dose titration with intravenous patient-controlled analgesia or switching from pretreatment with oral morphine or other opioids. A sequential trial showed less use of laxatives with transdermal fentanyl compared to pretreatment with oral morphine. Safety and efficacy of the transdermal system in clinical practice were confirmed in a nationwide survey with 1005 patients, nearly all of them with cancer pain. Most patients had been treated with opioids, though 22% had received no opioids or only as required before initiation of transdermal fentanyl. The mean duration of transdermal treatment was 71 +/- 83 days. Pain relief with transdermal therapy was swift and efficient. Adverse events with the possibility of a causal relationship to transdermal therapy were documented for 26% of the patients, most frequently nausea, vomiting, constipation and drowsiness. Severe neurotoxic or respiratory complications were reported only rarely. Problems with transdermal application were reported by 12% of the patients, with patch detachment and dermatologic symptoms on the site of application being most frequent. Most patients showered regularly with the patches and only three patients reported that patches became loose under the shower or in the bathtub. In a recent prospective trial driving ability was tested in patients with continuous non-cancer pain, who had received stable doses of transdermal fentanyl. Data were available from 90 healthy volunteers matched to 30 patients, of whom 9 were excluded from the analysis because they took additional drugs in violation of the protocol. None of the performance measures for the 21 remaining fentanyl patients was significantly inferior to the controls. In conclusion, experience with the transdermal therapeutic system with fentanyl has been gathered in clinical trials, a large nationwide survey and clinical practice since the release in 1995. The conversion table based on a conversion ratio of 100 : 1 was safe and efficient in trials and clinical practice. Transdermal fentanyl has become a wellknown and frequently used opioid in the treatment of chronic cancer and non-cancer pain in Germany.

Administration, Cutaneous↗

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 1304 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.

Austria↗

Encapsulation of an intrathecal catheter.

A 47-year-old patient with cancer pain underwent implantation of an intrathecal drug delivery device. When the patient suffered from an infection with fever, pain on injection into the catheter and an elevated number of granulocytes in the cerebrospinal fluid 7 weeks later, radiologic examination showed an encapsulation of the catheter tip. Concentrations of morphine and morphine-6-glucuronide in the cerebrospinal fluid suggested transport of morphine into the systemic circulation via the vascularisation of the encapsulating membrane. After antibiotic therapy and removal of the catheter, morphine was administered intravenously with a one to one conversion ratio.

Analgesics, Opioid↗

Driving ability under long-term treatment with transdermal fentanyl.

Clinical experience shows that neuropsychological side effects due to opioid therapy usually decrease during the first weeks of therapy. However, the effect of long-term treatment with transdermal fentanyl on complex activities, such as driving, is not yet clear. In a prospective trial, patients with continuous noncancer pain, who had received stable doses of transdermal fentanyl for at least 2 weeks, completed a series of computerized tests to measure attention, reaction, visual orientation, motor coordination and vigilance. Data from 90 healthy volunteers were matched to 30 patients; 9 patients were excluded from the per-protocol analysis because they took additional drugs in violation of the protocol. None of the performance measures for the 21 remaining fentanyl patients was significantly inferior to the controls. We conclude that stable doses of transdermal fentanyl for the treatment of chronic non-cancer pain are not associated with significant impairments in psychomotor and cognitive performance. The threshold for fitness to drive as defined by German law did not differ significantly between the groups.

Adult↗

Validation of the German version of the brief fatigue inventory.

Sedation and tiredness are among the most frequent symptoms among cancer patients. A detailed assessment of these symptoms is necessary to evaluate therapeutic effects, such as the use of methylphenidate or comparison of different opioids. The Brief Fatigue Inventory (BFI) has been validated as a short and comprehensive instrument to assess severity of fatigue and fatigue-related impairment in cancer patients. We validated the German version of the BFI in patients with chronic cancer-related and noncancer-related pain treated in a tertiary pain center. Patients treated in the Pain Clinic of the Department of Anesthesiology completed the BFI, the minimal documentation system (MIDOS) and the short form SF-36 quality-of-life questionnaire (SF-36). Test-retest reliability was assessed with a second BFI immediately after the consultation and in a subgroup of patients after 3 to 7 days. Nineteen percent of the 117 patients were treated for cancer-related pain (C); the other patients suffered from chronic severe pain of nonmalignant origin (NC). Patients reported mean values for average fatigue of 3.9 (C) and 4.9 (NC), and for worst fatigue of 5.5 (C) and 6.2 (NC). The mean score of the 6 impairment items was 4.3 in both groups. Factor analysis led to a solution with one common factor for all nine items. Fatigue on the BFI correlated highly with 'feeling tired' in the SF-36 and with 'sedation' in MIDOS, and less with 'being worn out' in SF-36 and 'weakness' in MIDOS. Internal consistency was high, as was test-retest reliability, with a correlation of the intensity, mean scores of 0.93 and the impairment mean scores of 0.87. In conclusion, we found the German version of the BFI to be reliable and valid for cancer and noncancer patients. Minor differences were seen in the validation compared to the original version.

Adult↗

Buprenorphine TDS: the clinical development rationale and results.

Buprenorphine, a powerful opioid, is newly available for delivery in a transdermal formulation. The transdermal system's matrix patch provides rate-controlled administration of the drug. Three double-blind, placebo-controlled trials were conducted to evaluate efficacy and tolerability of the buprenorphine transdermal system (buprenorphine TDS, Transtec). A total of 445 patients were enrolled in the studies. All suffered from moderate to severe and very severe pain, both cancer- or non-cancer-related. The percentage of responders increased as the rate of buprenorphine delivered by the transdermal system rose, ranging from a 29% (cancer) and 36% (non-cancer) response rate associated with the lowest dose (35 microg/h), to 40% (cancer) and 46% (non-cancer) with the highest dose (70 microg/h). Patients receiving buprenorphine TDS slept longer, uninterrupted by pain, than patients from the placebo group. Systemic adverse effects reported in the drug cohorts included nausea, vomiting and dizziness, and were typical of those reported in other studies of opioids; local adverse events, most commonly erythema and pruritus, were transient and mild to moderate. In an open-label, follow-up trial, in which 239 patients from the original clinical studies participated, 90% of patients reported that their analgesia was satisfactory or even better over a mean duration of 4.7 months; nearly 95% of patients found the patch to be user-friendly. The new buprenorphine TDS appears to be an important new modality for administering analgesia in patients with non-acute pain.

Analgesics, Opioid↗

Buprenorphine TDS: use in daily practice, benefits for patients.

In Germany and many other countries, buprenorphine has been used for a long time for the management of pain in both cancer and non-cancer patients. Although a transdermal delivery system for buprenorphine (Transtec) has recently been introduced, the clinical experience in daily practice with this drug, delivered in a matrix patch, is only now being evaluated. In preliminary data from a survey of 3,255 patients with chronic pain, 26% had cancer pain, while the most common diagnoses of the other respondents included back pain (33%), osteoarthritis (22%), osteoporosis (17%), and neuropathic pain (10%, multiple entries). Before being switched to the buprenorphine patch, most patients had been pretreated with World Health Organization (WHO) Step II opioids (47%) or WHO Step III opioids (18%), including tramadol (in 35% of patients) and a tilidin/naloxone combination (15%); 9% had not been prescribed any opioids in advance of receiving transdermal buprenorphine. Most patients (77%) in the survey had been started on the lowest dose of the buprenorphine patch (35 microg/h), and nearly half (49%) were placed on adjuvant analgesics, including tramadol or tilidin/naloxone. Pain relief was rated as good or very good by 81% of the respondents. Adverse effects were similar to those seen on other opioids, although their intensity was mild in most cases. Local side effects, including erythema (4% of cases) and pruritus (1%), were transitory. Based on the survey results, transdermal buprenorphine is considered an effective opioid treatment for patients with stable cancer and non-cancer pain; it may prove particularly useful in patients who have experienced side effects taking oral analgesic preparations, as well as in those who are taking extensive co-medications.

Administration, Cutaneous↗

[Internet-based conjoint analysis with the example of medical networks].

The present paper will demonstrate the usefulness of conjoint analysis in the area of medicine, a method that is well-known in consumer research. The aim was to investigate the preference structure of network-oriented physicians regarding competitive consulting and information offerings in the context of a hypothetical network between a hospital and office-based physicians. A combination of qualitative ("grounded theory") and quantitative ("conjoint analysis") methods was used. Combined items from the field of information, consultation, advanced training and financing were available. The following combination was preferred: attendance of a medical specialist in the outpatient department (factor "consultation"), the receipt of brief physician info letters (factor "information"), the possibility of discussing one's own patients with other physicians (factor "advanced training") and self-financing such an offer (factor "financing").

Humans↗

Patients' associations with regard to analgesic drugs and their forms for application -- a pilot study.

Patients' and caregivers' fear of addiction to and concern about side effects of morphine have been found to be among the major barriers to adequate pain relief in cancer patients. In contrast, the transdermal administration of opioids by means of fentanyl patches does not seem to evoke such fears. In a qualitative study, 60 patients in our outpatient pain clinic recorded up to five associations with a list of diseases, drugs and administration routes. Cancer and AIDS were associated most often with death, followed by suffering, anxiety and hopelessness. Migraine was associated predominantly with pain and other physical symptoms. Aspirin was associated less with pain in general than with headache and, sometimes, specifically with alcohol or hangover. Morphine was associated predominantly with pain and pain relief, but fears of intoxication, abuse and addiction and concerns about side effects were frequently named. Major differences were evident from the associations with the different routes of administration. The word 'pill' was mostly associated with contraception. Associations with 'tablets' were more pharmacological in nature, and side effects were frequently named. Patches were associated with wounds, cuts, bruises, and blisters and with protection. Some associations with patches were related to comfort. Injections and infusions were associated with physicians or the hospital environment. In conclusion, patients expressed major differences in their perceptions of the different drugs and routes of administration. The results may give a first hint that minor cultural differences even between western European countries may lead to major differences in prescribing habits and treatment regimens.

Acquired Immunodeficiency Syndrome↗