How to use the International Classification of Functioning, Disability and Health as a reference system for comparative evaluation and standardized reporting of rehabilitation interventions

Rehabilitation aims to optimize functioning of persons experiencing functioning limitations. As such the comparative evaluation of rehabilitation interventions relies on the analysis of the differences between the change in patient functioning after a specific rehabilitation intervention versus the change following another intervention. A robust health information reference system that can facilitate the comparative evaluation of changes in functioning in rehabilitation studies and the standardized reporting of rehabilitation interventions is the International Classification of Functioning, Disability and Health (ICF). The objective of this paper is to present recommendations that Cochrane Rehabilitation could adopt for using the ICF in rehabilitation studies by: 1) defining the functioning categories to be included in a rehabilitation study; 2) specifying selected functioning categories and selecting suitable data collection instruments; 3) examining aspects of functioning that have been documented in a study; 4) reporting functioning data collected with various data collection instruments; and 5) communicating results in an accessible, meaningful and easily understandable way. The authors provide examples of concrete studies that underscore these recommendations, whereby also em-phasizing the need for future research on the implementation of specific recommendations, e.g. in meta-analysis in systematic literature reviews. Furthermore, the paper outlines how the ICF can complement or be integrated in established Cochrane and rehabilitation research structures and methods, e.g. use of standard mean difference to compare cross-study data collected using different measures, in developing core outcome sets for rehabilitation, and the use of the PICO model. © 2019 EDIZIONI MINERVA MEDICA

Pain and analgesic use associated with skeletal-related events in patients with advanced cancer and bone metastases

PURPOSE: Bone metastases secondary to solid tumors increase the risk of skeletal-related events (SREs), including the occurrence of pathological fracture (PF), radiation to bone (RB), surgery to bone (SB), and spinal cord compression (SCC). The aim of this study was to evaluate the impact of SREs on patients' pain, analgesic use, and pain interference with daily functioning. METHODS: Data were combined from patients with solid tumors and bone metastases who received denosumab or zoledronic acid across three identically designed phase 3 trials (N = 5543). Pain severity (worst pain) and pain interference were assessed using the Brief Pain Inventory at baseline and each monthly visit. Analgesic use was quantified using the Analgesic Quantification Algorithm. RESULTS: The proportion of patients with moderate/severe pain and strong opioid use generally increased in the 6 months preceding an SRE and remained elevated, while they remained relatively consistent over time in patients without an SRE. Regression analysis indicated that all SRE types were significantly associated with an increased risk of progression to moderate/severe pain and strong opioid use. PF, RB, and SCC were associated with significantly greater risk of pain interference overall. Results were similar for pain interference with emotional well-being. All SRE types were associated with significantly greater risk of pain interference with physical function. CONCLUSIONS: SREs are associated with increased pain and analgesic use in patients with bone metastases. Treatments that prevent SREs may decrease pain and the need for opioid analgesics and reduce the impact of pain on daily functioning

Pain and analgesic use associated with skeletal-related events in patients with advanced cancer and bone metastases

PURPOSE: Bone metastases secondary to solid tumors increase the risk of skeletal-related events (SREs), including the occurrence of pathological fracture (PF), radiation to bone (RB), surgery to bone (SB), and spinal cord compression (SCC). The aim of this study was to evaluate the impact of SREs on patients' pain, analgesic use, and pain interference with daily functioning. METHODS: Data were combined from patients with solid tumors and bone metastases who received denosumab or zoledronic acid across three identically designed phase 3 trials (N = 5543). Pain severity (worst pain) and pain interference were assessed using the Brief Pain Inventory at baseline and each monthly visit. Analgesic use was quantified using the Analgesic Quantification Algorithm. RESULTS: The proportion of patients with moderate/severe pain and strong opioid use generally increased in the 6 months preceding an SRE and remained elevated, while they remained relatively consistent over time in patients without an SRE. Regression analysis indicated that all SRE types were significantly associated with an increased risk of progression to moderate/severe pain and strong opioid use. PF, RB, and SCC were associated with significantly greater risk of pain interference overall. Results were similar for pain interference with emotional well-being. All SRE types were associated with significantly greater risk of pain interference with physical function. CONCLUSIONS: SREs are associated with increased pain and analgesic use in patients with bone metastases. Treatments that prevent SREs may decrease pain and the need for opioid analgesics and reduce the impact of pain on daily functioning

Pain outcomes in patients with bone metastases from advanced cancer: assessment and management with bone-targeting agents

Bone metastases in advanced cancer frequently cause painful complications that impair patient physical activity and negatively affect quality of life. Pain is often underreported and poorly managed in these patients. The most commonly used pain assessment instruments are visual analogue scales, a single-item measure, and the Brief Pain Inventory Questionnaire-Short Form. The World Health Organization analgesic ladder and the Analgesic Quantification Algorithm are used to evaluate analgesic use. Bone-targeting agents, such as denosumab or bisphosphonates, prevent skeletal complications (i.e., radiation to bone, pathologic fractures, surgery to bone, and spinal cord compression) and can also improve pain outcomes in patients with metastatic bone disease. We have reviewed pain outcomes and analgesic use and reported pain data from an integrated analysis of randomized controlled studies of denosumab versus the bisphosphonate zoledronic acid (ZA) in patients with bone metastases from advanced solid tumors. Intravenous bisphosphonates improved pain outcomes in patients with bone metastases from solid tumors. Compared with ZA, denosumab further prevented pain worsening and delayed the need for treatment with strong opioids. In patients with no or mild pain at baseline, denosumab reduced the risk of increasing pain severity and delayed pain worsening along with the time to increased pain interference compared with ZA, suggesting that use of denosumab (with appropriate calcium and vitamin D supplementation) before patients develop bone pain may improve outcomes. These data also support the use of validated pain assessments to optimize treatment and reduce the burden of pain associated with metastatic bone disease

Experiences of living with chronic back pain: The physical disabilities

Purpose. Back-related functional limitations are largely assessed using lists of activities, each scored on a yes/no basis and the scores then summed. This provides little information about how chronic back pain (CBP) patients live with their condition. This study describes the consequences of living day-to-day with CBP and documents the 'insider' accounts of its impact on daily life. Method. Unstructured interviews, using the 'Framework' approach with topic guide, were recorded and transcribed verbatim. Subjects were sampled for age, sex, ethnicity and occupation from new referrals with back pain to a rheumatology outpatient clinic. Eleven subjects (5 male, 6 female) were interviewed either in English (n = 9) or their preferred language (n = 2). Interviews were read in-depth twice to identify the topics. Data were extracted in phrases and sentences using thematic content analysis. Results. Four themes emerged: sleep/rest, mobility, independence and leisure. All subjects reported issues about sleep and rest, nine about mobility, seven about independence and six on leisure. Most descriptions concerned loss and limitation in daily life. Strategies for coping with sleep disruption and physical limitations were described. Conclusions. Subjects provided graphic 'in-depth' descriptions of experiences living with CBP every day; expressed regret at the loss of capabilities and distress at the functional consequences of those losses. Facilitating 'adjustment' to 'loss' may be more helpful than inferring the potential for a life free of pain as a result of therapeutic endeavours