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

Impact of chronic pain on patients’ quality of life: A comparative mixed-methods study

Background: Chronic pain has become a common problem within primary care and can negatively impact patients’ lives. Objective: To assess and explore the impact of chronic pain on patients’ quality of life (QoL) using quantitative and qualitative data, respectively. Methods: A convergent parallel mixed-methods design was used. Chronic pain patients were recruited from a community-based pain clinic located in the North of England. Quality of life was assessed using Short-Form 36 version 2. Quality of life data were also extracted from the Third Oxford and Lifestyles Survey and Welsh Health Survey to allow comparison of QoL of chronic pain patients with that of the general population and patients with long-term conditions. Qualitative interviews were conducted face-to-face using a semistructured topic guide. Quantitative data were analyzed using SPSS version 24 and qualitative data were analyzed thematically. Results: Seventy-nine patients participated in the quantitative phase. The mean (standard deviation) age was 46.5 (14.5). Lower back (54; 68.3%) followed by lower limb were the most common pain sites. Compared with the general population and patients with long-term conditions, chronic pain patients had significantly lower mean QoL scores across all domains of SF-36 (All P < .05). Six themes emerged from qualitative data: interference with physical functioning, interference with professional life, interference with relationships and family life, interference with social life, interference with sleep, and interference with mood. Conclusion: The multidimensional negative impact of chronic pain leads to poorer QoL among patients with chronic pain compared to the general population and patients with other long-term conditions

Preliminary investigation of the associations between psychological flexibility, symptoms, and daily functioning in people with chronic abdominal pain

Objective: Acceptance and Commitment Therapy, based in the psychological flexibility model, may benefit people with chronic abdominal pain. The current study preliminarily investigates associations between psychological flexibility processes and daily general, social, and emotional functioning in chronic abdominal pain. Methods: An online survey comprising measures of psychological flexibility processes and daily functioning was distributed through social media. Subjects: 89 participants with chronic abdominal pain were included in the analyses. Results: All investigated psychological flexibility processes significantly correlated with pain interference, work and social adjustment, and depression, in the expected directions (|r|=.35-.68). Only pain acceptance significantly correlated with gastrointestinal symptoms, r=-.25. After adjusting for pain in the analyses, pain acceptance remained significantly associated with all outcomes, |β|=.28 to .56, but depression. After adjusting for pain and pain acceptance, only cognitive fusion remained significantly associated with anxiety, β=-.27, and depression, β=.43. When contrasting GI-specific anxiety with psychological flexibility processes, pain acceptance was uniquely associated with pain-related interference and work and social adjustment, and cognitive fusion and committed action were uniquely associated with depression. Conclusions: Psychological flexibility processes were positively associated with daily functioning in people with chronic abdominal pain. Acceptance and Commitment Therapy may provide benefit for these people. Further studies with experimental designs are needed to examine the utility of ACT for people with abdominal pain

The impact of meridian balance method electro-acupuncture treatment on chronic pelvic pain in women: a three-armed randomised controlled feasibility study using a mixed methods approach

Introduction:\ud Chronic pelvic pain (CPP) is estimated to affect 6%–27% of women worldwide. In the United Kingdom, over 1 million women suffer from CPP and it has been highlighted as a key area of unmet need. Standard treatments are associated with unacceptable side effects. The meridian balance method electro-acupuncture (BMEA), and traditional Chinese medicine health consultation (TCM HC) (BMEA + TCM HC = BMEA treatment) may be an effective adjunct to standard treatment.\ud \ud Aim:\ud The aim of our study was to evaluate the feasibility of a future trial, to determine the effectiveness of the BMEA treatment for CPP in women. The primary objectives were to determine recruitment and retention rates. The secondary objectives were to assess the effectiveness of the BMEA treatment and acceptability of the study’s methodology.\ud \ud Methods:\ud Women with CPP were randomised into BMEA treatment (group 1), TCM HC alone (group 2) (each intervention administered twice weekly for 4 weeks) or National Health Service standard care (NHS SC, group 3). Primary outcomes were assessed by the proportion of eligible participants randomised, and the proportion of randomised participants who returned follow-up questionnaires. Interventions were assessed by validated pain/physical/emotional functioning questionnaires at baseline (0), 4, 8 and 12 weeks. Focus groups and semi-structured telephone interviews were embedded in the study.\ud \ud Results:\ud A total of 30 women (51% of those referred) were randomised over 8 months. Retention rates were 80% (95% confidence interval (CI): 74–96), 53% (95% CI: 36–70) and 87% (95% CI: 63–90), in groups 1, 2, and 3, respectively. Qualitative data suggested a favourable trial experience in groups 1 and 3.\ud \ud Discussion:\ud Group 2 retention rate was problematic and has implications for our next trial.\ud \ud Conclusion:\ud Our study suggests that a future trial to determine the effectiveness of BMEA treatment for women with CPP is feasible but with modifications to the study design

Development and Initial Validation of the PEG, a Three-item Scale Assessing Pain Intensity and Interference

Inadequate pain assessment is a barrier to appropriate pain management, but single-item “pain screening” provides limited information about chronic pain. Multidimensional pain measures such as the Brief Pain Inventory (BPI) are widely used in pain specialty and research settings, but are impractical for primary care. A brief and straightforward multidimensional pain measure could potentially improve initial assessment and follow-up of chronic pain in primary care. To develop an ultra-brief pain measure derived from the BPI. Development of a shortened three-item pain measure and initial assessment of its reliability, validity, and responsiveness. We used data from 1) a longitudinal study of 500 primary care patients with chronic pain and 2) a cross-sectional study of 646 veterans recruited from ambulatory care. Selected items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G). Reliability of the three-item scale (PEG) was α = 0.73 and 0.89 in the two study samples. Overall, construct validity of the PEG was good for various pain-specific measures (r = 0.60–0.89 in Study 1 and r = 0.77–0.95 in Study 2), and comparable to that of the BPI. The PEG was sensitive to change and differentiated between patients with and without pain improvement at 6 months. We provide strong initial evidence for reliability, construct validity, and responsiveness of the PEG among primary care and other ambulatory clinic patients. The PEG may be a practical and useful tool to improve assessment and monitoring of chronic pain in primary care

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