What to Do, and What Not to Do, When Diagnosing and Treating Breakthrough Cancer Pain (BTcP): Expert Opinion.

Clinical management of breakthrough cancer pain (BTcP) is still not satisfactory despite the availability of effective pharmacological agents. This is in part linked to the lack of clarity regarding certain essential aspects of BTcP, including terminology, definition, epidemiology and assessment. Other barriers to effective management include a widespread prejudice among doctors and patients concerning the use of opioids, and inadequate assessment of pain severity, resulting in the prescription of ineffective drugs or doses. This review presents an overview of the appropriate and inappropriate actions to take in the diagnosis and treatment of BTcP, as determined by a panel of experts in the field. The ultimate aim is to provide a practical contribution to the unresolved issues in the management of BTcP. Five 'things to do' and five 'things not to do' in the diagnosis and treatment of BTcP are proposed, and evidence supporting said recommendations are described. It is the duty of all healthcare workers involved in managing cancer patients to be mindful of the possibility of BTcP occurrence and not to underestimate its severity. It is vital that all the necessary steps are carried out to establish an accurate and timely diagnosis, principally by establishing effective communication with the patient, the main information source. It is crucial that BTcP is treated with an effective pharmacological regimen and drug(s), dose and administration route prescribed are designed to suit the particular type of pain and importantly the individual needs of the patient.

Quality of life assessment and outcome of palliative care.

Quality of life (QoL) assessment is crucial for the evaluation of palliative care outcome. In this paper, our methodological approach was based on the creation of summary measures. Fifty-eight Palliative Care Units (PCUs) in Italy participated in the study. Each PCU randomly selected patients to be 'evaluated' among the consecutively 'registered' patients. At baseline (first visit) and each week the patient was asked to fill in a QoL questionnaire, the Therapy Impact Questionnaire (TIQ). Short-survivors (<7 days) were not included in the QoL study. The random sample of patients (n = 601) was highly representative of the general patient population cared for by the PCUs in Italy. The median survival was 37.9 days. We collected 3546 TIQ, 71.4 % completed by the patients. A Summary Measure Outcome score was calculated for 409 patients (81% of the patients included in the QoL study). The results of this national study showed that cooperative clinical research in palliative care is possible and QoL measures can be used to assess the outcome.

Terminal cancer patients and timing of referral to palliative care: a multicenter prospective cohort study. Italian Cooperative Research Group on Palliative Medicine.

This study describes the characteristics of a representative sample of terminally ill cancer patients at admission to Italian palliative care programs, the rate and reasons for discontinuation of care, and survival after enrollment. All Italian palliative care units (PCUs) specifically committed to palliative care were asked to consecutively register all new patients (n = 3901) between January and June, 1995. Fifty-eight of the 62 PCUs contacted by the Steering Committee completed the study. A random sample of 589 evaluable patients was prospectively selected from the 2667 eligible patients. Patients were mostly referred by a general practitioner (31.2%) or a specialist (42.1%). Most patients (84.7%) were followed until death. Seventy-seven discontinued care because of hospital admission (6.6%), change of residence (3.9%), refusal (1.7%), or improvement (0.8%). Median survival was 37.9 days; 14.3% of the patients died within 7 days, and 15.3% lived longer than 180 days. A statistically significant association between survival and gender, cancer type, setting of the first visit, and type of unit was observed. In Italy, as in other countries with different health systems, referral of cancer patients to palliative care tends to occur late in the course of the disease. This study suggests that the process of enrollment and the duration of patients' survival in palliative care, when studied in large unselected populations, can provide important information relevant to the care of terminally ill patients.

Home palliative care for terminal cancer patients: a survey on the final week of life.

As part of a large multicentre study on palliative care units in Italy, carried out between 1 January and 30 June 1995, we describe the place, circumstances and 'quality of death' of patients admitted to home palliative care. Data presented refer to 401 patients (67% of the 601 patients randomly selected for evaluation). Of these 401 patients 303 (76%) died at home. According to the Support Team Assessment Schedule (STAS) pain was fairly well controlled during the final week of life, while the control of other symptoms appeared to be less satisfactory. Invasive procedures were undertaken on 56% of patients, while in hospital the percentage increased to 75%. Twenty-five per cent of patients were totally pharmacologically sedated during the final 12 h of life. Neither the number of symptoms nor other factors were apparently associated with the decision to sedate the patient. The wide variations in the frequency of sedation among centres suggest that the choice to sedate the patient may reflect the provider's behaviour or services' policy rather than the patients' preference or needs. The definition of common criteria and guidelines for sedation of patients should be one of the topics for discussion among palliative care teams.

[Quality of life at the end of life. Analysis of the quality of life of oncologic patients treated with palliative care. Results of a multicenter observational study (staging)]. / La qualità di vita alla fine della vita. Analisi della qualità di vita di pazienti oncologici presi in carico per cure palliative. Risultati di uno studio osservazionale multicentrico ('staging').

Outcome in palliative care can be defined as patients' quality of life, quality of death and satisfaction with care. In an Italian multicentre prospectic study ('Staging') the quality of life of 571 palliative care patients with advanced cancer disease was assessed since the beginning of palliative care till the end of the study. We analyzed the tissue of quality of life missing data and the possibility to input the missing quality of life evaluation through the quality of life evaluation made by a proxy (doctor, nurse). The greatest functional impairment and an increasing level of some symptoms (fatigue, general malaise, emotional status) were observed during the last two weeks of life, whereas for other symptoms (gastro-intestinal, pain) some degree of control was possible. The quality of life analysis for palliative care patients should consider the different response of different quality of life components to the palliative care intervention.

Quality-of-life evaluation: when do terminal cancer patients and health-care providers agree?

A multicenter study involving six palliative care units in Italy was carried out on 159 terminal cancer patients seen at home or in hospital. The physician or the nurse completed independently from the patient the Therapy Impact Questionnaire (TIQ), a questionnaire devised for quality-of-life evaluation in terminal cancer patients. The patient's assessment was used as the valid reference measurement to compare with the health-care workers' evaluation to assess the validity of the latter. The results showed that percentages of agreement were higher for physical than for psychological and cognitive symptoms, and that there was a greater agreement on the absence rather than on the presence of a problem. None of the characteristics of the patient nor of the proxy showed any statistically significant relationship with the two disagreement indexes. The results suggest that caution is needed in the use of health-care workers as alternative sources of information regarding patients' quality of life.

Outcome evaluation in a home palliative care service.

The complexity of assessing the impact of palliative care is much greater than in other fields of medicine, due to the shortcomings of traditional outcome indicators. We conducted a prospective study to describe the patient's quality of life at the outset and during palliative care at home and to define some potential indicators of palliative care outcomes with the aim of assessing the quality of home care as provided by a palliative care unit. Seventy-three patients who received care at home were assessed. The median survival in palliative home care was 29 days. To evaluate the degree of symptom distress, we used an Italian version of the Symptom Distress Scale. Assessing the quality-of-life pattern over time, we observed that palliative care was effective in mitigating pain and, at least in part, in stimulating appetite, curbing nausea, and controlling psychological aspects. The subscales referring to social and functional aspects steadily worsened. The difficulties encountered (the high percentage of missing data, the considerable number of patients treated for less than 10 days, etc.) should be a warning against using only one assessment instrument. It is worthwhile defining the various potential outcomes of palliative care even though all results will not always be measurable in every patients. Only a global assessment, a "multiple outcomes approach," based on different indicators, would allow for evaluation of the outcome of the care process.

Quality-of-life assessment in a home care program for advanced cancer patients: a study using the Symptom Distress Scale.

Quality-of-life assessment in advanced cancer patients should include the study of physical function, psychological status, social interactions, and symptoms. "Symptom distress" relates to the degree of discomfort caused by specific symptoms. A Symptom Distress Scale, which has been developed by McCorkle and Young, is a self-rating instrument that evaluates 13 symptoms. In the present study, the Italian version of the Symptom Distress Scale (SDS) was used to assess the quality of life in advanced cancer patients. The internal consistency of this version was found to be good (Cronbach's coefficient alpha = 0.78). A sample group of 43 patients treated in a home care program was asked to fill out the SDS on a weekly basis. The scores showed a reduction in symptom distress, which was primarily due to improvement in pain, nausea, and bowel pattern. Home care was less effective in improving concentration and, more generally, psychological aspects. This study confirms the validity of a quality-of-life monitoring system that uses a patient self-rating symptom assessment instrument.

Nursing care planning for terminally ill cancer patients receiving home care.

Nursing home care for terminally ill cancer patients was organized according to nursing care plans that were based on diagnoses as recommended by the North American Nursing Diagnosis Association (NANDA). This study was carried out among a sample of 40 patients receiving home health care for a period of 1 to 19 weeks. More than 697 nursing diagnoses were identified in the study. The most frequently recorded nursing diagnoses were anxiety, constipation, and diminished food intake. Fifteen of the 40 patients in the study were able to complete a weekly self-report of their symptoms. The patients' own descriptions of their symptoms were then compared with their symptoms as identified by nursing staff. There was a congruence in 63% of reported instances. Although nurses' assessments were not always in agreement with the symptoms reported by the patients, agreement was more frequently found with somatic symptoms than with psychological ones. One conclusion is that nursing plans should incorporate multidimensional methods for assessing patients' real needs.