Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial.

BACKGROUND: The quality of care provided to patients with cancer who are dying in hospital and their families is suboptimum. The UK Liverpool Care Pathway (LCP) for patients who are dying was developed with the aim of transferring the best practice of hospices to hospitals. We therefore assessed the effectiveness of LCP in the Italian context (LCP-I) in improving the quality of end-of-life care for patients with cancer in hospitals and for their family. METHODS: In this pragmatic cluster randomised trial, 16 Italian general medicine hospital wards were randomly assigned to implement the LCP-I programme or standard health-care practice. For each ward, we identified all patients who died from cancer in the 3 months before randomisation (preintervention) and in the 6 months after the completion of the LCP-I training programme. The primary endpoint was the overall quality of care toolkit scale. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01081899. FINDINGS: During the postintervention assessment, data were gathered for 308 patients who died from cancer (147 in LCP-I programme wards and 161 in control wards). 232 (75%) of 308 family members were interviewed, 119 (81%) of 147 with relatives cared for in the LCP-I wards (mean cluster size 14·9 [range eight to 22]) and 113 (70%) of 161 in the control wards (14·1 [eight to 22]). After implementation of the LCP-I programme, no significant difference was noted in the distribution of the overall quality of care toolkit scores between the wards in which the LCP-I programme was implemented and the control wards (score 70·5 of 100 vs 63·0 of 100; cluster-adjusted mean difference 7·6 [95% CI -3·6 to 18·7]; p=0·186). INTERPRETATION: The effect of the LCP-I programme in our study is less than the effects noted in earlier phase 2 trials. However, if the programme is implemented well it has the potential to reduce the gap in quality of care between hospices and hospitals. Further research is needed to ascertain what components of the LCP-I programme might be effective and to develop and assess a wider range of approaches to quality improvement in hospital care for people at the end of their lives and for their families. FUNDING: Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus.

Palliative sedation at the end of life at a tertiary cancer center.

PURPOSE: The aim of this study was to describe the use of palliative sedation (PS) its indications and outcomes in patients followed up till death by an inpatient palliative care consult team (PCCT) at a tertiary cancer center. METHODS: All patients referred for 5 years to the PCCT and followed up till death were eligible for the study. Both PCCT recordings and hospital charts were reviewed and a codified assessment was performed. RESULTS: Over a total of 2,033 consecutive consults, 129 patients died during admission and were eligible. Eighty-three had the indication to PS, 4% of all consults (95% confidence interval [95%CI], 3% to 5%) and 64% of eligible patients (95%CI, 56% to 73%). PS was more frequently indicated in males and in patients with recurrent dyspnea and recurrent agitation, while it was less frequently indicated in older people and in patients with cerebral metastases and recurrent drowsiness. The most frequent indications to PS were dyspnea (37%) and delirium (31%) alone or combined with other symptoms. PS was successfully achieved in 69 patients; the drugs most frequently used for PS were midazolam (46%), haloperidol (35%), and chlorpromazine (32%) and opioid dose escalation was higher in sedated patients (P < 0.01). CONCLUSIONS: PS is an important intervention in the management of terminal disease by a consulting palliative care team. Improved collaboration and communication between the hospital staff and the PCCT should be offered to meet patients' needs when PS is required.

Comparison of numerical and verbal rating scales to measure pain exacerbations in patients with chronic cancer pain.

BACKGROUND: Numerical rating scales (NRS), and verbal rating scales (VRS) showed to be reliable and valid tools for subjective cancer pain measurement, but no one of them consistently proved to be superior to the other. Aim of the present study is to compare NRS and VRS performance in assessing breakthrough or episodic pain (BP-EP) exacerbations. METHODS: In a cross sectional multicentre study carried out on a sample of 240 advanced cancer patients with pain, background pain and BP-EP intensity in the last 24 hours were measured using both a 6-point VRS and a 0-10 NRS. In order to evaluate the reproducibility of the two scales, a subsample of 60 patients was randomly selected and the questionnaire was administered for a second time three to four hours later. The proportion of "inconsistent" (background pain intensity higher than or equal to peak pain intensity) evaluations was calculated to compare the two scales capability in discriminating between background and peak pain intensity and Cohen's K was calculated to compare their reproducibility. RESULTS: NRS revealed higher discriminatory capability than VRS in distinguishing between background and peak pain intensity with a lower proportion of patients giving inconsistent evaluations (14% vs. 25%). NRS also showed higher reproducibility when measuring pain exacerbations (Cohen's K of 0.86 for NRS vs. 0.53 for VRS) while the reproducibility of the two scales in evaluating background pain was similar (Cohen's K of 0.80 vs. 0.77). CONCLUSIONS: Our results suggest that, in the measurement of cancer pain exacerbations, patients use NRS more appropriately than VRS and as such NRS should be preferred to VRS in this patient's population.

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.

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.

Hyperalgesia and myoclonus with intrathecal infusion of high-dose morphine.

We report the case of a patient who developed myoclonus and hyperalgesia following administration of high-dose subarachnoid morphine. This complication occurred with 40-80 mg/day continuous infusion. The pathophysiology of these side effects is discussed.

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.

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.

The validity of average 8-h pain intensity assessment in cancer patients.

Aim of this study was to validate the use of subjective average pain assessment over an 8-h time period to evaluate cancer pain intensity. A sample of 95 consecutive cancer inpatients were asked to score on 0-10 numerical scales the intensity of their pain at hourly intervals, and then, at the 8th hour, to rate their average pain intensity over the last 8h. Agreement between the average of the 8 hourly measures (8hA) and the single patient-rated average (PA8h) was examined with the intraclass correlation coefficient (ICC) and the absolute difference (AD) between the two measurements. Associations between AD, gender, age older than 70, somatic pain, visceral pain, neuropathic pain, pain on movement and the presence of pain exacerbations during the 8-h period, were also examined. Average pain intensity scores were very similar with the two measurement schedules: 3.4 for 8hA and 3.7 for PA8h, with a median AD of 0.44 points. Only six patients (6.3%) showed ADs higher than 2 points. Also the ICC (0.85) showed a substantial agreement between the two schedules. Among the examined variables, gender, age over 70years and presence of pain exacerbations showed a significant association with the agreement level. Overall, our results support the validity of a subjective average pain measurement over 8-h period in cancer patients.

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.