Fibromyalgia 2016 criteria and assessments: comprehensive validation in a Norwegian population.

Background and aims The ACR1990 criteria of fibromyalgia (FM) have been criticized due to poor reliability of tender points counting (TPC), inconsistent definitions of the widespread pain, and by not considering other symptoms than pain in the FM phenotype. Therefore, several newer self-report measures for FM criteria have emerged. The aim of this study was to translate the fibromyalgia survey questionnaire (FSQ) to Norwegian and validate both the 2011 and the 2016 fibromyalgia survey diagnostic criteria (FSDC) against the ACR1990 criteria. Methods One hundred and twenty chronic pain patients formerly diagnosed with fibromyalgia according to the ACR1990 criteria, and 62 controls not diagnosed or where fibromyalgia was not suspected, were enrolled in this study. All responded to a Norwegian version of the FSQ. Also, they had a clinical examination according to ACR1990 fibromyalgia criteria including a counting of significant tender points with an algometer (TPC). The FSQ with the Widespread Pain Index (WPI) and Symptom Severity scale (SSS) subscales, Fibromyalgia Severity (FS) sum score, was examined for correlations with the fibromyalgia impact questionnaire (FIQ) and TPCs. Face-validity, internal consistence, test-retest reliability and construct validity with convergent and divergent approaches were examined and a Receiver Operating Characteristics (ROC) analysis was performed. Results The internal consistency of FS measured by Cronbach's alfa was good (=0.904). The test-retest reliability measures using intra class correlation were respectable for the FS, including WPI and SSS subscales (0.86, 0.84 and 0.87). FS, WPI and SSS correlated significantly with FIQ (0.74, 0.59 and 0.85) and TPC indicating an adequate construct, convergent validity. The medians of FS, WPI and SSS in the fibromyalgia-group were significantly different from the non-fibromyalgia-group indicating good construct, divergent validity. Using the 2011 and 2016 FSDC vs. ACR 1990 as a reference, sensitivity, specificity, positive likelihood ratio (LR +) and negative likelihood ratio (LR-) were identified. The accuracy rate for both 2011 and 2016 FSDC were respectable (84%). ROC analysis using FS revealed a very good Area Under the Curve (AUC) = 0.860. Conclusion The current study revealed that the Norwegian versions of FSQ is a valid tool for assessment of fibromyalgia according to the 2011 and 2016 (FSDC).

Characteristics and prognosis of primary treatment-naïve oral cavity squamous cell carcinoma in Norway, a descriptive retrospective study.

OBJECTIVES: Incidence of oral cavity squamous cell carcinomas is rising worldwide, and population characterization is important to follow for future trends. The aim of this retrospective study was to present a large cohort of primary oral cavity squamous cell carcinoma from all four health regions of Norway, with descriptive clinicopathological characteristics and five-year survival outcomes. MATERIALS AND METHODS: Patients diagnosed with primary treatment-naïve oral cavity squamous cell carcinomas at all four university hospitals in Norway between 2005-2009 were retrospectively included in this study. Clinicopathological data from the electronic health records were compared to survival data. RESULTS: A total of 535 patients with primary treatment-naïve oral cavity squamous cell carcinomas were identified. The median survival follow-up time was 48 months (range 0-125 months) after treatment. The median five-year overall survival was found to be 47%. Median five-year disease-specific survival was 52%, ranging from 80% for stage I to 33% for stage IV patients. For patients given treatment with curative intent, the overall survival was found to be 56% and disease-specific survival 62%. Median age at diagnosis was 67 years (range 24-101 years), 64 years for men and 72 years for women. The male: female ratio was 1.2. No gender difference was found in neither tumor status (p = 0.180) nor node status (p = 0.266), but both factors influenced significantly on survival (p<0.001 for both). CONCLUSIONS: We present a large cohort of primary treatment-naïve oral cavity squamous cell carcinomas in Norway. Five-year disease-specific survival was 52%, and patients eligible for curative treatment had a five-year disease-specific survival up to 62%.

Users' perceptions on digital visualization of neuropathic cancer-related pain.

Quality pain management implies a thorough pain assessment with structured communication between patients and healthcare providers. Pain distribution is an important dimension of cancer pain. Assessment of pain distribution is commonly performed on a pain body map. This study explores how a computerized pain body map may function as a communication tool and visualize pain in patients with advanced cancer. In previous studies, we have developed a tablet-based computerized pain body map for use in cancer patients. The aim of this study was to adapt the computerized pain body map program to patients with neuropathic cancer-related pain, and to develop a separate interface for healthcare providers. We also wanted to investigate the perceived usefulness of this system among patients and healthcare providers. Both patients and healthcare providers perceived that the visualization of pain in the computerized pain body map system had potential to be a positive contribution to clinical pain management, and to improve collaboration between healthcare providers.

Efficacy and tolerability of intranasal fentanyl spray in cancer patients with breakthrough pain.

PURPOSE: The aims of this study were to explore the efficacy of intranasal fentanyl spray* (INFS) 400 µg to evaluate 12-week tolerability of the nasal mucosa and to explore safety data for all dose strengths of INFS in patients with cancer-related breakthrough pain (BTP). METHODS: Patients received a test dose of INFS 50 µg, followed by a titration phase. Those patients with doses titrated to 200 or 400 µg entered a randomized, double-blind, cross-over efficacy phase, in which 8 episodes of BTP were randomly treated with INFS 400 µg (6 episodes) and placebo (2 episodes), followed by a tolerability phase. Patients with doses titrated to 50 or 100 µg entered the tolerability phase directly. Primary outcome was measured by pain intensity difference at 10 minutes, analyzed using ANCOVA, and presented as least square mean difference. Examination of the nasal cavity was conducted at inclusion and after 12 weeks of treatment by an otorhinolaryngologist. FINDINGS: Forty-six patients were included. Thirty-eight patients' doses were titrated to an effective dose of INFS; 50 µg (n = 8), 100 µg (n = 9), 200 µg (n = 9), and 400 µg (n = 12); 15 patients entered the efficacy phase and 31 entered the tolerability phase. In the efficacy phase, 88 and 29 episodes of BTP were treated with INFS 400 µg and placebo, respectively. Pain intensity difference at 10 minutes least square mean for INFS 400 µg was 2.5 (95% CI, 1.42-3.49) (P < 0.001) and least square mean difference between INFS 400 µg and placebo was 1.1 (95% CI, 0.41-1.79) (P = 0.002). Runny nose (10%) and change in color of the mucosa (9%) were the most frequent findings of nasal examination, and nausea and dizziness were the most frequent treatment-related adverse events. One serious adverse event (ie, respiratory depression) was considered related to INFS. IMPLICATIONS: INFS 400 µg is effective and nasal tolerability and overall safety profile is acceptable during 12 weeks of use. ClinicalTrials.gov identifier: NCT01429051.

Development and testing of a computerized pain body map in patients with advanced cancer.

CONTEXT: Pain localization is an important part of pain assessment. Development of pain tools for self-report should include expert and patient input, and patient testing in large samples. OBJECTIVES: To develop a computerized pain body map (CPBM) for use in patients with advanced cancer. METHODS: Three studies were conducted: 1) an international expert survey and a pilot study guiding the contents and layout of the CPBM, 2) clinical testing in an international symptom assessment study in eight countries and 17 centers (N = 533), and 3) comparing patient pain markings on computer and paper body maps (N = 92). RESULTS: Study 1: 22 pain experts and 28 patients participated. A CPBM with anterior and posterior whole body views was developed for marking pain locations, supplemented by pain intensity ratings for each location. Study 2: 533 patients (286 male, 247 female, mean age 62 years) participated; 80% received pain medication and 81% had metastatic disease. Eighty-five percent completed CPBM as intended. Mean ± SD number of marked pain locations was 1.8 ± 1.2. Aberrant markings (15%) were mostly related to software problems. No differences were found regarding age, gender, cognitive/physical performance, or previous computer experience. Study 3: 70% of the patients had identical markings on the computer and paper maps. Only four patients had completely different markings on the two maps. CONCLUSION: This first version of CPBM was well accepted by patients with advanced cancer. However, several areas for improvement were revealed, providing a basis for the development of the next version, which is subject to further international testing.