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Biomedical subjects

Augusto Caraceni

Publications and source records attributed to Augusto Caraceni.

At least 19 recordsLinked to original sources
PubMed2006

Pain in cancer. An outcome research project to evaluate the epidemiology, the quality and the effects of pain treatment in cancer patients.

BACKGROUND: Management of pain related to advanced or metastatic cancer, although the availability of several pharmacological and non-pharmacological interventions and the existence of well-known guidelines and protocols, is often difficult and inadequate. Evidence of the relative effectiveness of current options for treating cancer pain from comparative randomized studies is scanty. METHODS: In the context of a wider project, a multicenter, open label, prospective Outcome Research study will be launched in Italy in 2006 to investigate the epidemiology of cancer pain and of its treatments, the quality of analgesic-drug therapy and the effectiveness of alternative analgesic strategies in a large, prospective, unselected cohort of cancer patients using the state-of-the art of patient-reported-outcomes. About 100 Italian centers will recruit 2500 patients with advanced/progressive/metastatic cancer with pain (related to the cancer disease) requiring analgesic treatments. Each center is expected to recruit 25 consecutive and eligible patients during the study inception period. Approximately two months will be allowed for subject recruitment and enrollment. Subject evaluation and follow-up will be for 3 months. The effect on outcomes of various therapeutic analgesic options administered by physicians, given the observational approach where patients are not assigned at random to different treatments, will be compared using the propensity score approach, allowing the adjustment for treatment selection bias. Later, after the launch of the observational study and on the basis of results, in specific subsamples of patients and in select centers of the network, a Randomized Controlled Trial will be carried out to formally compare the efficacy of alternative analgesic strategies, with particular emphasis on oral morphine (as comparator) and buprenorphine patch (as experimental arm). Results from the outcome (cohort) and experimental (Randomized Controlled Trial) studies will ensure both the external and internal validity.

Adult↗
PubMed2006

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↗
PubMed2005

Prognostic factors in advanced cancer patients: evidence-based clinical recommendations--a study by the Steering Committee of the European Association for Palliative Care.

PURPOSE: To offer evidence-based clinical recommendations concerning prognosis in advanced cancer patients. METHODS: A Working Group of the Research Network of the European Association for Palliative Care identified clinically significant topics, reviewed the studies, and assigned the level of evidence. A formal meta-analysis was not feasible because of the heterogeneity of published studies and the lack of minimal standards in reporting results. A systematic electronic literature search within the main available medical literature databases was performed for each of the following four areas identified: clinical prediction of survival (CPS), biologic factors, clinical signs and symptoms and psychosocial variables, and prognostic scores. Only studies on patients with advanced cancer and survival < or = 90 days were included. RESULTS: A total of 38 studies were evaluated. Level A evidence-based recommendations of prognostic correlation could be formulated for CPS (albeit with a series of limitations of which clinicians must be aware) and prognostic scores. Recommendations on the use of other prognostic factors, such as performance status, symptoms associated with cancer anorexia-cachexia syndrome (weight loss, anorexia, dysphagia, and xerostomia), dyspnea, delirium, and some biologic factors (leukocytosis, lymphocytopenia, and C-reactive protein), reached level B. CONCLUSION: Prognostication of life expectancy is a significant clinical commitment for clinicians involved in oncology and palliative care. More accurate prognostication is feasible and can be achieved by combining clinical experience and evidence from the literature. Using and communicating prognostic information should be part of a multidisciplinary palliative care approach.

Biomarkers↗
PubMed2005

Epidural spinal cord compression.

Spinal cord compression from epidural metastases (epidural spinal cord compression, ESCC) is the most common neurological complication of cancer after brain metastases. Extradural compression represents 97% of spinal cord metastatic lesions. ESCC usually occurs in patients with disseminated disease. The most common tumours associated with ESCC are lung and breast cancers, followed by lymphoma, myeloma, prostate cancer and sarcoma. ESCC represents a medical emergency because delayed treatment can be responsible for irreversible deficits, such as paralysis and loss of sphincter control. Patients with ESCC require a multidisciplinary diagnostic and therapeutic approach. Clinical suspect is radiologically detected for confirmation. The median expected survival time from diagnosis usually ranges from 3 to 6 months. The nature of the primary tumour and the degree of the neurological deficit are the most important factors affecting survival. The lack of prospective randomized trials makes the optimal treatment of ESCC controversial and the decision is to be tailored to the individual. Treatment options include: bed rest, administration of corticosteroids, surgery followed by radiation therapy, radiotherapy alone and, to a limited extent, chemotherapy and hormonal therapy.

Epidural Neoplasms↗
PubMed2005

Symptomatic and neurophysiological responses of paclitaxel- or cisplatin-induced neuropathy to oral acetyl-L-carnitine.

Acetyl-L-carnitine (ALC) improves non-oncological neuropathies. We tested oral ALC (1 g tid) for 8 weeks in 25 patients with neuropathy grade 3 (common toxicity criteria--CTC) during paclitaxel or cisplatin therapy, or grade 2 persisting for at least three months after discontinuing the drugs. An independent neurologist assessed patients before and after ALC. All patients except one reported symptomatic relief, and only two described grade 1 nausea. The sensory neuropathy grade improved in 15 of 25 (60%), and motor neuropathy in 11 of 14 patients (79%). Total neuropathy score (TNS) that included neurophysiological measures improved in 23 (92%). Amelioration of sensory amplitude and conduction velocity (sural and peroneal nerves) was measured in 22 and 21 patients, respectively. Symptomatic improvement persisted in 12 of 13 evaluable patients at median 13 months after ALC. In view of its effect in improving established paclitaxel- and cisplatin-neuropathy, we recommend ALC testing in preventing progression or revert symptoms during neurotoxic chemotherapy.

Acetylcarnitine↗
PubMed2005

Cancer pain assessment in clinical trials. A review of the literature (1999-2002).

The aim of this review was to evaluate the methods of pain measurement in controlled clinical trials in oncology published between 1999 and 2002. An electronic literature search strategy was used according to established criteria applied to the Medline database and PubMed search engine. Articles were selected to include only studies that had chronic cancer pain as the primary or secondary objective of a controlled clinical trial. A specific evaluation scheme was used to examine how pain measurement methods were chosen and implemented in the study procedures. The search strategy identified 613 articles, and 68 were selected for evaluation. Most articles (69%) chose unidimensional pain measurement tools, such as visual analogue scales, numerical rating scales and verbal rating scales, whereas others used questionnaires. The implementation of the pain assessment method was problematic in many studies, especially as far as time frame of pain assessment (70%), administration modalities (46%), and use of non-validated measurement methods (10%). Design of study and data analysis were often unclear about the definition of pain outcome measure (40%), patient compliance with pain assessment (98%), and impact of missing data (56%). Statistical techniques were seldom appropriate to the type of data collected and often inadequate to describe the pain variable under study. It is clear from this review that most authors were aware of the need of valid pain measurement tools to be used in clinical trials. However, too often these tools were not appropriately used in the trial, or at least their use was not described with sufficient accuracy in the trial methods.

Chronic Disease↗
PubMed2004

Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group.

PURPOSE: To determine the analgesic effect of the addition of gabapentin to opioids in the management of neuropathic cancer pain. PATIENTS AND METHODS: One hundred twenty-one consecutive patients with neuropathic pain due to cancer, partially controlled with systemic opioids, participated in a multicenter, randomized, double-blind, placebo-controlled, parallel-design, 10-day trial from August 1999 to May 2002. Gabapentin was titrated from 600 mg/d to 1,800 mg/d in addition to stable opioid dose. Extra opioid doses were available as needed. Zero to 10 numerical scale was used to rate average daily pain. The average pain score over the whole follow-up period was used as main outcome measure. Secondary outcome measures were: intensity of burning pain, shooting/lancinating pain, dysesthesias (also scored on 0 to 10 numerical scale), number of daily episodes of lancinating pain, presence of allodynia, and daily extra doses of opioid analgesics. RESULTS: Overall, 79 patients received gabapentin and 58 (73%) completed the study; 41 patients received placebo and 31 (76%) completed the study. Analysis of covariance (ANCOVA) on the intent-to-treat population showed a significant difference of average pain intensity between gabapentin (pain score, 4.6) and placebo group (pain score, 5.4; P =.0250). Among secondary outcome measures, dysesthesia score showed a statistically significant difference (P =.0077; ANCOVA on modified intent-to-treat population = 115 patients with at least 3 days of pain assessments). Reasons for withdrawing patients from the trial were adverse events in six patients (7.6%) receiving gabapentin and in three patients receiving placebo (7.3%). CONCLUSION: Gabapentin is effective in improving analgesia in patients with neuropathic cancer pain already treated with opioids.

Acetates↗
PubMed2004

Cancer patient compliance in the self-administration of a pain assessment tool.

Accurate pain assessment is considered essential for effective management of cancer pain. The aim of this study was to evaluate the compliance of hospitalized patients with chronic cancer pain, referred to an inpatient palliative care consultation service, with self-assessment of pain intensity by means of a daily pain form. The form was distributed daily by the pain consult nurse and required three daily pain intensity measurements on 0 to 10 numerical scales, separately for pain at rest and pain on movement. Of 174 consecutive patients, 106 (61%) participated in the study and were followed up for a median of 10.6 days (range 1-32 days). Compliance was defined as the number of assessment forms completed over the number of evaluation days available for each patient. Mean compliance was 58%. The main reasons for not completing the form were related to subjective psychological variables (44%), physical distress (26%), and absence of pain (16%). Lack of understanding of the method was reported as the main reason for non-compliance by only 1% of patients.

Adult↗
PubMed2004

Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey.

Breakthrough pain (BKP) is a transitory flare of pain that occurs on a background of relatively well controlled baseline pain. Previous surveys have found that BKP is highly prevalent among patients with cancer pain and predicts more severe pain, pain-related distress and functional impairment, and relatively poor quality of life. An international group of investigators assembled by a task force of the International Association for the Study of Pain (IASP) evaluated the prevalence and characteristics of BKP as part of a prospective, cross-sectional survey of cancer pain. Fifty-eight clinicians in 24 countries evaluated a total of 1095 patients with cancer pain using patient-rated items from the Brief Pain Inventory (BPI) and observer-rated measures. The observer-rated information included demographic and tumor-related data, the occurrence of BKP, and responses on checklists of pain syndromes and pathophysiologies. The clinicians reported BKP in 64.8% of patients. Physicians from English-speaking countries were significantly more likely to report BKP than other physicians. BKP was associated with higher pain scores and functional interference on the BPI. Multivariate analysis showed an independent association of BKP with the presence of more than one pain, a vertebral pain syndrome, pain due to plexopathy, and English-speaking country. These data confirm the high prevalence of BKP, its association with more severe pain and functional impairment, and its relationship to specific cancer pain syndromes. Further studies are needed to characterize subtypes of BKP. The uneven distribution of BKP reporting across pain specialists from different countries suggests that more standardized methods for diagnosing BKP are needed.

Analysis of Variance↗
PubMed2002

Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care.

BACKGROUND: Breakthrough pain is transitory exacerbation of pain that occurs in addition to otherwise stable persistent pain. The wide differences in estimation of incidence reported in literature are probably because of different settings and meanings attributed to the definition of breakthrough pain. METHODS: A panel of experts met to establish the actual knowledge on breakthrough pain, according to the evidence in literature and experience. They agreed that episodic or transient pain could be a more simple and adequate term in most languages, including English, French, Italian, and Spanish. RESULTS: A specific assessment and precise pain characterization are essential to plan the most appropriate treatments. Despite the relevance of this temporal pain pattern for the influence on the outcome and quality of life, few controlled studies have been performed to give evidence of a specific approach. Several experiences have reported the possible efficacy of different drugs, route of administration, and modalities of administration in different circumstances. CONCLUSIONS: Prospective studies with previous treatments using similar terminologies are necessary to find the most convenient therapeutic intervention, according to the temporal pattern characteristics and the pain mechanism involved.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2002

Pain measurement tools and methods in clinical research in palliative care: recommendations of an Expert Working Group of the European Association of Palliative Care.

An Expert Working Group was convened under the auspices of the Steering Committee of the Research Network of the European Association of Palliative Care to review the status of the use of pain measurement tools (PMTs) in palliative care research conducted in a multilingual-multicenter setting. Based on a literature review and on the experts' opinion, the present work recommends that standardized methods should be applied for the use of PMTs in research in palliative care. Visual analogue scales, numerical rating scales, and verbal rating scales are considered valid to assess pain intensity in clinical trials and in other types of studies. Among the multidimensional questionnaires designed to assess pain, the McGill Pain Questionnaire and Brief Pain Inventory are valid in many multilingual versions. Specific recommendations for PMT use and administration, depending on the study type and aim, are reviewed. Special population requirements specific of clinical situations encountered in palliative care (elderly, terminal, cognitively impaired patients, pediatric patients) are also considered.

Europe↗
PubMed1999

An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International Association for the Study of Pain.

The optimal assessment of cancer pain includes a detailed description of pain characteristics and classification by both syndrome and likely mechanisms. In the clinical setting, the interpretation of this information is aided by knowledge of the available clinical experiences on these aspects of the pain. Unfortunately, existing data are limited. There have been few large surveys of cancer pain characteristics and syndromes, and comparative data from patients in different parts of the world are entirely lacking. To better define the characteristics of cancer pain syndromes the Task Force on Cancer Pain of the International Association for the Study of Pain (IASP) conducted a prospective, cross-sectional, international, multicenter survey of pain specialists and their patients. From a total of 100 clinicians who described themselves as cancer pain practitioners in the IASP membership directory, 51 agreed to participate in the survey and a total of 58 provided data. These clinicians resided in 24 countries and evaluated a total of 1095 patients with severe cancer pain mostly requiring opioid medication, using a combination of patient-rated and observer-rated measures. The patient-rated scales comprised a pain intensity measure chosen from the brief pain inventory. The observer-rated information included demographic and tumor-related data, and responses on checklists of pain syndromes and pathophysiologies. Patients were heterogeneous in terms of demographics and tumor-related information. More than 76% had a Kamofsky performance status score < or = 70. Almost one-quarter of the patients experienced two or more pains. A large majority of the patients (92.5%) had one or more pains caused directly by the cancer; 20.8% of patients had one or more pains caused by cancer therapies. The average (SD) duration of pain was 5.9 (10.5) months. Approximately two-thirds of patients (66.7%) reported that the worst pain intensity during the day prior to the survey was > or = 7 on a 10-point numeric scale. The factors that were univariately associated with higher pain intensity included the presence of breakthrough pain, somatic pain or neuropathic pain, age younger than 60 years, and lower performance status score. A multivariate model suggested that the presence of breakthrough pain, somatic pain, and lower performance status were the most important predictors of intense pain. Pains that were inferred by the treating clinician to be nociceptive and due to somatic injury occurred in 71.6% of the patients. Pains labeled nociceptive visceral were noted in 34.7% and pains inferred to have neuropathic mechanisms occurred in 39.7%. In a broad classification, the major pain syndromes comprised bone or joint lesions (41.7% of patients), visceral lesions (28.1%), soft tissue infiltration (28.3%), and peripheral nerve injuries (27.8%). Twenty-two types of pain syndromes were most prevalent. Large differences in the diagnosis of breakthrough pain by clinicians of different countries suggest that this phenomenon is either defined or recognized differently across countries. These data confirm, in segment of the cancer population experiencing severe pain, in different parts of the world, that cancer pain characteristics, syndromes and pathophysiologies are very heterogeneous. Predictors of worsening pain can be identified. The data provide a useful context for the interpretation of pain-related information acquired in both clinical and research settings. They suggest the need for future studies and the potential usefulness of a written checklist for cancer pain syndromes and pathophysiologies.

Cross-Sectional Studies↗
PubMed1996

A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore).

Aim of this study was to validate the Italian version of the Brief Pain Inventory (BPI), Breve Questionario per la Valutazione del Dolore (BQVD), which is a multidimensional instrument to assess pain intensity and pain interference with daily functions. A group of 110 patients with cancer pain were enrolled in the study and were administered the BQVD and the Therapy Impact Questionnaire (TIQ) which is a valid instrument for quality of life assessment in cancer patients. Cronbach's alphas were computed for the interference and severity scales in assessing reliability. Confirmatory factor analysis was utilized to ascertain construct validity of the BQVD. Measures of interference and of intensity were calculated a priori from the TIQ result and were used in correlated correlations. Alpha coefficients for the pain severity and the pain interference scale were above 0.75. Confirmatory factor analysis showed that a 2-factor solution for the BQVD structure was interpretable and provided adequate fit for the data. The correlation with the TIQ items showed a stronger association between factor 1 (interference) and the interference with affect and activity measure from the TIQ, while factor 2 (severity) was more strongly associated with the TIQ pain severity measure. In comparison with other non-italian samples our results show a lower reliability estimate. Overall the analysis of these data shows that the BQVD is a useful and valid tool in assessing pain and its impact on patients' quality of life which could also help in developing international and cross-cultural studies in cancer pain.

Adult↗
PubMed1994

Pain measurement in cancer patients: a comparison of six methods.

A consecutive sample of 53 chronic cancer pain patients were administered 5 different pain intensity scales: a visual analogue scale (VAS), a numerical rating scale from 0 to 10 (NRS), a verbal rating scale (VRS), the Italian Pain Questionnaire (Italian version of the McGill Pain Questionnaire) (PRI), and the Integrated Pain Score (IPS) which is an instrument designed at the Pain Therapy and Palliative Care Division of the National Cancer Institute of Milan to integrate pain intensity and duration in a single measure. These scales were administered before and after a definite therapy change. At the time of the second evaluation the patients were also administered a pain relief scale (IRS). A factor analysis of the scoring properties of these instruments revealed a high degree of association between the variables. A single factor clearly emerged explaining most of the different scales variability. A logistic regression analysis showed that VAS, NRS, VRS were more strongly associated with IRS than PRI and IPS.

Adult↗
PubMed1993

Paraplegia following coeliac plexus block.

Coeliac plexus block (CPB) is one of the few neurolytic procedures that is still considered very useful in managing chronic cancer pain. We describe what we believe to be the fifth case in the literature of paraplegia following coeliac plexus block with ethyl alcohol. Clinical and neurophysiological examination confirmed the hypothesis of an acute myelopathy probably caused by ischemia due to involvement of Adamkievicz's artery. The seriousness of this neurological complication led us to review the different pain-relieving strategies in pancreatic cancer. Several medical and surgical procedures are available for advanced pancreatic cancer, yet none of them alone can be considered the therapy of choice for all cases. Hence, only a multidisciplinary approach to pancreatic cancer pain can help in making the most appropriate choice for each patient.

Adenocarcinoma↗