Translation, Cultural Adaption, and Linguistic Validation of the Norwegian Wound-QoL Questionnaire.

Background and Purpose: A sound translation is complex but necessary to provide a valid patient-reported questionnaire. The aim of this study was therefore to translate, culturally adapt, and linguistically validate the 17-item Wound-Quality of Life (Wound-QoL) questionnaire from English to Norwegian. Methods: For translation and cultural adaption of the Wound-QoL, we followed the methods described by the ISPOR-The Professional Society for Health Economics and Outcomes Research (formerly, the International Society for Pharmacoeconomics and Outcome Research), Messaging Application Programming Interface Research Institute, and recommendations from literature reviews. Results: Differences in the language semantics and syntax caused challenges in the translation. The cognitive debriefing interviews revealed some irrelevant items related to personal preferences. Conclusions: This study provides a questionnaire that can improve the quality of clinical care and promote research and valuable knowledge to other researchers translating the Wound-QoL and similar questionnaires.

Nurse-Led Telephone Follow-Up Intervention for Titrating and Tapering Opioids in Chronic Pain Patients - A Feasibility Study.

Background and Purpose: Opioids in chronic non-cancer pain are debated, but remain a part of the pain treatment for selected patients. Research is scarce on the relieving and adverse effects of opioids, and how to deliver opioid treatment in this patient group. This study's purpose was to assess the feasibility of a nurse-led telephone follow-up intervention for titrating or tapering opioids, including a pilot study of the intervention outcomes. Patients and Methods: The feasibility assessment and process evaluation were performed according to the UK Medical Research Council (MRC) framework for evaluating complex interventions. A pilot study of the intervention outcomes was also performed. With a retrospective, descriptive, and longitudinal approach, we analyzed reports from 32 patients who titrated or tapered opioids. Information on demography, sleep satisfaction, health status, pain intensity/bothersomeness, opioid doses, and side effects was derived from the Oslo Pain Registry. Descriptive statistics, t-tests, and chi-square tests were used to analyze registry data. Results: The study findings indicate that the intervention is feasible. Areas of impact were lack of a sound theory basis, unclear allocation criteria, and inconsistent and non-validated measurement tools. Mechanisms of change were interprofessional collaboration, nurses' knowledge and competencies, predictability, and availability. Statistical analyses showed no between-groups differences in demographical-, clinical-, and pain characteristics, except those who titrated opioids were significantly older than patients tapering opioids (P=0.010). All patients reported poor health and side effects at baseline. Those who tapered opioids had a significant reduction in opioid use (P=0.004). Titrating opioids was associated with a significant increase in side effects (P=0.038). Conclusion: Considering the limitations and the strengths of the intervention, the present study indicates that the nurse-led telephone follow-up program is a feasible intervention. With the right adjustments and improvements, the intervention is eligible for a larger efficacy study.

The Individual Placement and Support (IPS) in Pain Trial: A Randomized Controlled Trial of IPS for Patients with Chronic Pain Conditions.

OBJECTIVES: Although complex pain conditions require an interdisciplinary approach, employment services are rarely provided in pain centers. Individual Placement and Support (IPS) is an effective approach to increase work participation among patients with severe mental illness, and recent evidence suggests that this method can be successfully repurposed for new target groups. We aimed to investigate the effectiveness of IPS integrated with interdisciplinary treatment as usual (TAU) for patients with chronic pain in a tertiary pain center. METHODS: A randomized controlled trial comparing IPS integrated with TAU (n = 38) with TAU alone (n = 20) was conducted. Participants were patients with chronic pain who were 18-65 years of age and currently on long-term sick leave or disability benefits or unemployed. The primary outcome was employment within 12 months after enrollment, with additional long-term follow-up after 24 months. Secondary outcomes included health and quality of life, measured at baseline, 6 months, and 12 months. RESULTS: During 12-month follow-up, 52.8% in the IPS group and 38.9% in the TAU group had attained employment. The difference increased during 24-month follow-up but did not reach statistical significance. Findings on secondary outcomes were generally nonsignificant. CONCLUSIONS: The IPS in Pain trial is the first study to evaluate the effect of IPS for patients with chronic pain conditions. It shows that IPS can be integrated into the daily practice of interdisciplinary pain treatment, with employment rates exceeding 50% in 1 year and a clear trend in favor of the IPS group. Results did not, however, reach significance. Larger randomized controlled trials are needed to draw clear conclusions about effectiveness.

Perceived Injustice in Patients With Chronic Pain: Prevalence, Relevance, and Associations With Long-Term Recovery and Deterioration.

The Injustice Experience Questionnaire (IEQ) assesses the degree to which chronic pain sufferers perceive injustice in relation to their pain. The aim of the current study was to assess the prevalence and relevance of the IEQ and its association to perceived recovery and deterioration in a naturalistic pain clinic population. Data was obtained from the Oslo University Hospital's Pain Registry. Among 2,950 patients, the prevalence of low (<19), medium (19-29) and high (30+) IEQ was 39%, 32% and 29% respectively. High levels of injustice were positively associated with a wide range of adverse health outcomes. Differences between those with high vs low levels of IEQ were clinically significant for most health outcomes. A Venn diagram analysis showed considerable, but not complete, overlap between IEQ, pain catastrophizing, psychological distress and severe pain intensity. High IEQ was associated with reduced clinical recovery (OR 0.6, 95% CI 0.4-0.9) and deterioration (OR 3.6, 95% CI 2.1-6.2) at 12-months follow-up, however, not when controlling for pain-related disability and pain intensity. We conclude that perceived injustice is a prevalent and clinically relevant phenomenon in a chronic pain clinic population, and that more knowledge is needed regarding its role as indicator of poor prognosis and target for tailored treatment. PERSPECTIVE: This article shows that pain-related injustice is both prevalent and relevant in a large naturalistic pain clinic population. Higher levels of injustice were consistently associated with adverse pain outcomes. Injustice could as such be a viable target for treatment of chronic pain, with potential indirect effects on pain and disability.

Translation and validation of the Norwegian version of the Injustice Experience Questionnaire.

OBJECTIVES: Perceived injustice is a theoretical construct comprising elements of loss, attribution of blame, and sense of unfairness. Patients with chronic pain often report high levels of perceived injustice, which can have negative impact on physiological and psychosocial aspects and treatment outcome. The Injustice Experience Questionnaire (IEQ) is a self-report 12-item questionnaire that shows good reliability and validity in patients with chronic pain. This study aimed to translate, validate, and expand the use of the Norwegian Injustice Experience Questionnaire (IEQ-N) to a chronic pain population. METHODS: A mixed-method approach was used to translate and validate the IEQ-N. It was forward-back translated, linguistically validated, and culturally adapted. Individual cognitive debriefing interviews (n=7) and a focus group interview (n=9) was used to explore the patients' experience with- and understanding of the questionnaire. Statistical descriptive, correlational, factor- and regression analyses were used to investigate the IEQ-N validity, reliability, and factorial structure in a large registry sample (n=3,068) of patients with chronic pain. RESULTS: Patients with chronic pain found the IEQ-N relevant. Registry analyses supported that the IEQ-N had a one-factor structure. The internal consistency was high (Chronbach's alpha=0.92). The construct validity was good, with moderate to strong significant univariate correlation (r=0.29-0.71) (p<0.05) between perceived injustice and related constructs of pain catastrophizing, pain severity, disability, psychological distress, and quality of life. Perceived injustice contributed with significant but small unique variance to pain-related factors (i.e., pain intensity, pain-related disability, psychological distress), but the additional contribution beyond pain catastrophizing was small (0.2-6.7%) (p<0.05). CONCLUSIONS: Patients in the study found the questionnaire relevant for their situation, and easy to understand. This study provides a reliable and valid Norwegian tool to assess perceived injustice in patients with chronic pain. ETHICAL COMMITTEE NUMBER: REK sør-øst, 2016/1942.

The complex experience of psoriasis related skin pain: a qualitative study.

Background and aims Psoriasis is a common chronic skin condition, causing skin lesions with thickened and scaling skin, as well as erythema and inflammation that may involve painful sores, cracks, and pustules. Previously psoriasis was regarded as a painless skin condition. However, over the past decade studies show that skin pain is a frequently reported and bothersome symptom in patients with psoriasis. There is however a lack of rich narratives describing the experience of skin pain in these patients. The aims of this qualitative study were therefore to explore in depth how patients experience psoriasis-related skin pain, and how they deal with it. Methods Thirteen patients with psoriasis were recruited from a dermatology ward and outpatient clinic. One of the investigators (TML) performed individual, semi-structured interviews at an undisturbed room in the hospital. Interviews were thematically analyzed using the method of Systematic Text Condensation as described by Malterud (2012). Results Three main themes were identified from the interviews. First, the skin pain experience was complex. Patients used a variety of adjectives and metaphors to describe their pain, and their skin was sensitive to stimuli of every-day activities. Itch was a common cosymptom, and could both mask pain but also cause severe pain due to excessive scratching and damage to the skin. Second, skin pain had a negative impact on patients' life. Skin pain reduced their physical activity level, impaired their sleep, and made them irritable, depressed, unconcentrated on tasks, as well as withdrawn from other people and social activities. Third, patients dealt with their skin pain in various ways. Although some took action to relieve the pain and distract themselves from pain, most of the patients applied maladaptive and passive coping strategies such as put up with it, avoid painful activities, become fearful or trivialize their pain. Conclusions The experience of psoriasis related skin pain is complex. The pain has a major negative impact on patients' life in terms of physical, emotional, cognitive, and social functions. Patients use a variety of adaptive but most frequently maladaptive coping strategies in order to deal with their skin pain. Implications This study provides new and in-depth knowledge on psoriasis related skin pain. This information is valuable for further work on pain assessment tools and pain management recommendations customized for skin pain experienced by patients with psoriasis.

Improvement in Psoriasis Area and Severity Index score predicts improvement in skin pain over time in patients with psoriasis.

Pain and discomfort are common and often severe skin symptoms in patients with psoriasis. However, no studies have investigated skin pain and discomfort over time, or factors that explain changes in these symptoms. The aims of the present study were to describe the changes in skin pain, skin discomfort and Psoriasis Area and Severity Index (PASI) over time, and to investigate whether change in PASI predicted change in skin pain intensity. A total of 129 patients participated in this exploratory, longitudinal study. Data were obtained through interviews and questionnaires. The results indicated reduction in skin symptoms and psoriasis severity over a period of 3 months. However, a majority of patients with skin pain at baseline reported also skin pain at follow-up. Furthermore, changes in PASI predicted changes in skin pain intensity. In conclusion, improvement in psoriasis severity predicts improvement in skin pain.

Skin pain and discomfort in psoriasis: an exploratory study of symptom prevalence and characteristics.

Few studies have investigated subjective sensory skin symptoms in patients with psoriasis. The aim of this study was to investigate prevalence and characteristics of psoriasis-related skin pain and discomfort, and evaluate differences in demographic/clinical characteristics among patients with or without skin symptoms. A total of 139 patients was recruited for this exploratory, descriptive, cross-sectional study. Data were obtained through interviews and questionnaires. While 42.6% reported skin pain, 36.7% reported skin discomfort. Mean average symptom intensity score (0-10 numeric rating scale) was 4.4 for pain and 3.5 for discomfort. Unpleasant, surface, sensitive, itchy, and hot/burning were the most common symptom qualities. Sleep was the most severely affected function. No differences were found in demographic characteristics. However, larger proportions of patients with skin symptoms had more severe psoriasis (p < 0.05). In conclusion, pain and discomfort are more common and more severe in patients with psoriasis than previously estimated.

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids.

Objective Patients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain. Methods A 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 µg/h. This was titrated to 10 or 20 µg/h, as needed. Rescue analgesic was paracetamol 0.5-4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates. Results Most patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 µg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0-10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients' Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 110 [corrected] days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups. Conclusions Although the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients' global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period. Implications A low dose 7-days buprenorphine patch at 5-20 µg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.