Jane M. Ingham

Care for the caregivers: a review of self-report instruments developed to measure the burden, needs, and quality of life of informal caregivers

Significant demands are being placed on the informal caregivers of chronically ill patients, including those suffering from cancer. Health care professionals need to be aware of these demands, and they need effective tools to assess the impact these demands place on the caregivers. Over the past 25 years, researchers have developed self-report instruments to assess informal caregivers. These instruments assess various aspects of the caregiving experience, including caregiver burden, needs, and quality of life. The purpose of this review was to identify and critically evaluate these instruments. MEDLINE and PUBMED were searched from 1966 to 2002. After an extensive literature search and review, and utilizing specific inclusion criteria, 28 instruments were identified and evaluated in terms of their development, content, and psychometric properties. In addition, a history of the construct and measurement development in the areas of caregiver burden, needs, and quality of life are discussed. Although some further development and refinement of instruments could benefit the field, depending on the questions researchers or clinicians seek to pursue, there are many proven tools available for their use. Future research needs to use these instruments to assess the effectiveness of interventions aimed at improving the care of the caregivers.

Oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in cancer patients: a controlled dose titration study

Oral transmucosal fentanyl citrate (OTFC) is a novel opioid formulation in which the potent synthetic mu-agonist fentanyl is embedded in a sweetened matrix that is dissolved in the mouth. It is undergoing investigation as a treatment for cancer-related breakthrough pain, a prevalent phenomenon defined as a transitory flare of moderate to severe pain that interrupts otherwise controlled persistent pain. There have been no controlled trials of other treatments for this condition. To evaluate the safety and efficacy of ascending doses of OTFC, a novel controlled dose titration methodology was developed that applied blinding and randomization procedures to the evaluation of recurrent pains in the home environment. The study was a multicenter, randomized, double-blind dose titration study in ambulatory cancer patients. The sample comprised adult patients receiving a scheduled oral opioid regimen equivalent to 60-1000 mg oral morphine per day, who were experiencing at least one episode per day of breakthrough pain and had achieved at least partial relief of this pain by use of an oral opioid rescue dose. After collection of 2 days of baseline data concerning the efficacy of the usual rescue drug, patients were randomly treated with either 200 or 400 microg OTFC unit doses in double-blind fashion. Up to two breakthrough pains each day could be treated with up to four OTFC unit doses per pain. OTFC in unit doses containing 200, 400, 600, 800, 1200 or 1600 microg of fentanyl citrate were available for the study. The unit dose was titrated upward in steps until the patient had 2 consecutive days on which breakthrough pain could be treated with the single unit dose, titration was ineffective at a 1600 microg unit dose, or 20 days elapsed. To maintain the double-blind, orders to titrate up were ignored one-third of the time according to a pre-defined randomization schedule accessible only to an unblinded study pharmacist. Main outcome measures included, numeric or categorical measures of pain intensity, pain relief, and global assessment of drug performance. Dose response relationships were found suggesting that the methodology was sensitive to opioid effects. Seventy-four percent of patients were successfully titrated. There was no relationship between the total daily dose of the fixed schedule opioid regimen and the dose of OTFC required to manage the breakthrough pain. Although the study was not designed to provide a definitive comparison between OTFC and the usual rescue drug, exploratory analyses found that OTFC provided significantly greater analgesic effect at 15, 30 and 60 min, and a more rapid onset of effect, than the usual rescue drug. Adverse effects of the OTFC were typically opioid-related, specifically somnolence, nausea and dizziness. Very few adverse events were severe or serious. This study demonstrated the feasibility of controlled trial methodology in studies of breakthrough pain. OTFC appears to be a safe and effective therapy for breakthrough pain, and dose titration can usually identify a unit dose capable of providing adequate analgesia. If the lack of a relationship between the effective OTFC dose and fixed schedule opioid regimen is confirmed, dose titration may be needed in the clinical use of this formulation. Further investigation of OTFC as a specific treatment for breakthrough pain is warranted.

Opioid pharmacotherapy in the management of cancer pain. A survey of strategies used by pain physicians for the selection of analgesic drugs and routes of administration

Background. This survey documents the strategies used by pain control physicians in the selection of opioid drugs and routes of administration in the management of inpatients referred to a cancer pain service.

The quality of medical care at the end-of-life in the USA: existing barriers and examples of process and outcome measures

Context: Cancer is a leading cause of morbidity and mortality in the USA and despite many recent advances in detection and treatment, over half a million cancer patients in this country will die from their disease each year. Objective: Using cancer as a prototype, we provide a conceptual framework to identify and review barriers to optimal end-of-life care and propose examples of linked process and outcome measures that could be used to evaluate whether standards of optimal end-of-life care are being achieved. Methods: We propose a conceptual model of end-of-life care and use this model to review the published literature to identify the key goals of optimal end-of-life care and summarize existing barriers to optimal end-of-life care. We then provide examples of process and outcome measures linked to the goals of optimal end-of-life care and domains within the conceptual framework. Results: Within all components of care at the end-of-life-societal attitudes, health care system(s), providers, and patients and their families — there are significant barriers to the quality of care. Some of the most critical barriers to optimal care at the endof-life in the USA are limited availability, and coverage of, co-ordinated service delivery; poor provider communication and diagnostic skills; limited opportunities for training in palliative care; patient fears and attitudes towards the sick role, and a lack of, or inadequate health insurance. Proposed patient, provider, and system level measures of the quality of care were guided by goals of optimal end-of-life care, and focus on communication about prognosis and risks and benefits of treatment, development of clear and informed treatment goals, delivery of services consistent with treatment goals, and promotion of quality of life. Conclusions: At present, there are substantial societal, health care system, provider, and patient barriers to obtaining optimal cancer care at the end-of-life. Ongoing discussions about appropriate measures of the quality of end-of-life care are gaining momentum, however. The proposed process and outcome measures for assessing optimal end-of-life care use cancer as a prototype, but are broadly applicable to other patient populations with life-threatening disease.

Retrospective studies of end-of-life resource utilization and costs in cancer care using health administrative data: a systematic review.

Background: There has been an increase in observational studies using health administrative data to examine the nature, quality, and costs of care at life’s end, particularly in cancer care. Aim: To synthesize retrospective observational studies on resource utilization and/or costs at the end of life in cancer patients. We also examine the methods and outcomes of studies assessing the quality of end-of-life care. Design: A systematic review according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (A Measurement Tool to Assess Systematic Reviews) methodology. Data sources: We searched MEDLINE, Embase, CINAHL, and York Centre for Research and Dissemination (1990–2011). Independent reviewers screened abstracts of 14,424 articles, and 835 full-text manuscripts were further reviewed. Inclusion criteria were English-language; at least one resource utilization or cost outcome in adult cancer decedents with solid tumors; outcomes derived from health administrative data; and an exclusive end-of-life focus. Results: We reviewed 78 studies examining end-of-life care in over 3.7 million cancer decedents; 33 were published since 2008. We observed exponential increases in service use and costs as death approached; hospital services being the main cost driver. Palliative services were relatively underutilized and associated with lower expenditures than hospital-based care. The 15 studies using quality indicators demonstrated that up to 38% of patients receive chemotherapy or life-sustaining treatments in the last month of life and up to 66% do not receive hospice/palliative services. Conclusion: Observational studies using health administrative data have the potential to drive evidence-based palliative care practice and policy. Further development of quality care markers will enhance benchmarking activities across health care jurisdictions, providers, and patient populations.

Pain and the Barriers to Its Relief at the End of Life: A Lesson for Improving End of Life Health Care

Pain among cancer patients is a common distressing symptom that frequently affects physical functioning, social interaction, psychological status, and quality of life. Despite the extensive body of knowledge available regarding cancer pain assessment and management, it often remains untreated, thereby diminishing the quality of patient care at the end of life. Recommendations on how to remove these barriers, as well as to improve care of the dying in general, need to be implemented by the U.S. government.

The management of spinal cord compression in patients with advanced malignancy

We retrospectively evaluated the medical records of 17 hospice patients who developed spinal cord or cauda equina compression due to metastatic epidural tumor to ascertain the nature and outcome of the disorder in this setting. Epidural compression occurred following admission to the hospice in five cases and prior to admission in 12 cases. Six patients were ambulatory following treatment, and this favorable outcome occurred only in those who were ambulatory at diagnosis. In the group of patients who were paraplegic after treatment, problems related to pain, decubitus ulcers, and constipation were most challenging. This experience highlights the need for a more vigilant approach to back pain in patients at risk of epidural compression in the hospice setting. Further studies are necessary to establish the appropriate management of these patients.

An exploratory study of frequent pain measurement in a cancer clinical trial

The ideal methodology for quality of life (QOL) measurement in cancer clinical trials matches the evaluation to the anticipated outcomes, thereby increasing the likelihood that clinically relevant changes are captured. The present study explored the importance of such methodological ‘tailoring’ in a phase II trial of paclitaxel and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for metastatic breast cancer. Prior to the trial, clinical observation suggested that frequent short-lived episodes of pain might occur during this treatment regimen. Twenty-one patients provided longitudinal data for at least three cycles of chemotherapy. To assess transient pain, aroutine QOL assessment at baseline and every third cycle was supplemented with pain measurements twice weekly. The interval assessment included a multidimensional QOL instrument (Functional Living Index-Cancer) and measures of psychological state (Rand Mental Health Inventory), symptom distress (Memorial Symptom Assessment Scale), and performance status (Karnofsky Performance Status Score). The frequent pain measurements were acquired using visual analogue and categorical scales for pain intensity (Memorial Pain Assessment Card). From baseline to the end of cycle three, global pain scores declined and the results on other QOL measures were variable. The data obtained using these measures did not reveal the existence of episodic pains. In contrast, the twice weekly pain measurements clearly demonstrated transient severe pains in approximately half the patients. These data highlight the importance of specific measurement of troubling symptoms or other relevant QOL concerns at clinically appropriate intervals during the routine QOL assessment of clinical trials. The additional burden involved in these assessments is warranted if the information derived is highly relevant, would not be adequately captured otherwise and could improve therapy.

The use of non-invasive ventilation for the relief of dyspnoea in exacerbations of chronic obstructive pulmonary disease; a systematic review

Background and objective:  Non‐invasive ventilation (NIV) improves outcomes in patients with acute exacerbations of COPD (AECOPD); however, the efficacy in relieving dyspnoea is uncertain. The objective of this systematic review was to identify, synthesize and interpret the data regarding the relief of dyspnoea afforded by NIV in patients admitted with acute respiratory failure occurring during AECOPD.

Drugs in the treatment of pain: NSAIDS and opioids

Non-steroidal anti-inflammatory drugs and opioids are mainstay drugs for the treatment of both acute and chronic pain. Clinical guidelines for the administration of both classes have evolved from a large practical experience in diverse patient populations, and a growing literature describing basic and clinical pharmacology. Recent studies have illuminated their mechanisms of action and have demonstrated that the widely recognized peripheral analgesic effects produced by these compounds are probably complemented by direct actions in the central nervous system. Other work has clarified the relative toxicities of the various compounds in this class and highlighted strategies for the prevention of serious adverse effects. Recent studies of opioid drugs have focused on the role of morphine metabolites, the implications of relative opioid responsiveness, and the continuing controversy surrounding the use of these drugs in the management of chronic non-malignant pain.