5-point Categorical Scale Research Articles

Effectiveness of hypofractionated radiotherapy in painful bone metastases. Two prospective studies with 1 x 4 Gy and 4 x 4 Gy.

Although effectiveness of fractionated radiotherapy for painful bone metastases is well documented, there are unanswered questions regarding the adequacy of low-dose short radiation schedules for long-term pain control which give maximum benefit in patients with a short life expectancy. Two consecutive non-randomized prospective follow-up studies were performed at a single institution to analyze pain response and duration of response in patients with a variety of primary tumors. Included were only patients with symptomatic nonvertebral bone metastases and without impending pathologic fracture. Forty-five patients received 1 x 4 Gy to 50 different sites (group I) while 86 patients received 4 x 4 Gy to 96 sites (group II). Pain relief to irradiation was evaluated according to patient interviews using a 4-point categorical scale. Follow-up was performed 7 and 90 days after radiotherapy. Pain relief after 4 x 4 Gy was significantly superior to 1 x 4 Gy with pain control rates being 86.5% vs 48% at day 7 (after end of treatment) and 80% vs 55% at day 90, respectively. A subgroup analysis of patients treated with 4 x 4 Gy demonstrated a more favorable outcome for breast cancer patients in comparison to patients with other primaries concerning pain relief (96% vs 81%), pain control after 90 days (93% vs 72%), median time to pain progression (9 vs 3 months), and median overall survival (14 vs 5.5 months). In this study 4 x 4 Gy proved to be clearly superior to 1 x 4 Gy in relieving pain from symptomatic nonvertebral bone metastases without impending pathologic fracture. Even if radiotherapy with 1 single fraction seems to be applicable in specific cases doses higher than 4 Gy should be chosen. In breast cancer patients pain control seems to be better compared to other primaries.

The visual analogue pain intensity scale: what is moderate pain in millimetres?

One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity. The usual criterion is at least moderate pain on a categorical pain intensity scale. When visual analogue scales (VAS) are the only pain measure in trials we need to know what point on a VAS represents moderate pain, so that these trials can be included in meta-analysis when baseline pain of at least moderate intensity is an inclusion criterion. To investigate this we used individual patient data from 1080 patients from randomised controlled trials of various analgesics. Baseline pain was measured using a 4-point categorical pain intensity scale and a pain intensity VAS under identical conditions. The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain. The VAS scores corresponding to moderate or severe pain were also examined by gender. Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain. Of the patients reporting moderate pain 85% scored over 30 mm on the corresponding VAS, with a mean score of 49 mm. For those reporting severe pain 85% scored over 54 mm with a mean score of 75 mm. There was no difference between the corresponding VAS scores of men and women. Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4-point categorical scale.

Efficacy of controlled-release codeine in chronic non-malignant pain: a randomized, placebo-controlled clinical trial

Treatment decisions for the use of opioid analgesics in chronic non-malignant pain are based primarily on survey data, as evidence from well-controlled clinical trials has been lacking. Forty-six patients with chronic non-malignant pain were enrolled in a randomized, double-blind, placebo-controlled evaluation of controlled-release (CR) codeine. Following a 3–7-day diary familiarization period, patients were randomly assigned to 7 days of treatment each with CR codeine q12h or placebo. The CR codeine dose was determined from the consumption of acetaminophen + codeine in the 7 days preceding the study. During both phases, breakthrough pain was treated with acetaminophen + codeine every 4 h as required. Pain intensity was assessed at 08:00 h and 20:00 h using a visual analogue scale (VAS) and a 5-point categorical scale, and rescue analgesic consumption was recorded at the time of use. Thirty patients (17 female, 13 male; mean age: 55.1 ± 13.4 years) completed the study and were treated with a mean daily CR codeine dose of 273 ± 78 mg (range: 200–400 mg). CR codeine treatment resulted in significantly lower overall VAS pain intensity scores (35 ± 18 vs. 49 ± 16, P = 0.0001), categorical pain intensity scores (1.7 ± 0.6 vs. 2.2 ± 0.6, P = 0.0001), and in pain scores by day of treatment and by time of day. Daily rescue analgesic consumption was significantly lower on CR codeine, relative to placebo treatment (3.6 ± 3.5 vs. 6.1 ± 3.2 tablets/ day, P = 0.0001). There was also a significant reduction in the Pain Disability Index (PDI) on CR codeine, compared to placebo (25.0 ± 7.7 vs. 35.1 ± 8.2, P = 0.0001). Patients' and investigators' blinded treatment preference was significantly in favor of CR codeine, relative to placebo (73% vs. 10%, P = 0.0160 and 80% vs. 7%, P = 0.0014, respectively). The incidence of nausea was significantly higher on CR codeine than on placebo (32.6% vs. 11.9%, P = 0.013). Ninety-three percent of patients completing the study requested long-term, open-label treatment with CR codeine. Pain intensity scores at the completion of 19 weeks of long-term evaluation were comparable to those during the double-blind CR codeine treatment. We conclude that treatment with CR codeine results in reduced pain and pain-related disability in patients with chronic non-malignant pain.

Diagnostic Performance of Two‐Dimensional Versus Three‐Dimensional Transesophageal Echocardiography Images of Selected Pathologies Evaluated by Receiver Operating Characteristic Analysis

The sensitivity and specificity of 2-D and 3-D echocardiographic images for the detection of selected morphological abnormalities were compared using receiver operating characteristic (ROC) analysis. Five experienced clinical echocardiographers blinded to the patients' diagnoses evaluated the 20 original static 2-D image sets and 20 corresponding 3-D reconstructions using a five point categorical scale that ranged from definitely abnormal to definitely normal. The ROC curve for the 3-D images was significantly (P < 0.05) closer to the ideal discrimination function than was the ROC curve for the 2-D transesophageal images (i.e., the sensitivity of the 3-D images was higher than that of the 2-D sequential images at the same specificity). 3-D transesophageal images provided better visual clues for the identification of morphological abnormalities than did serial 2-D echocardiographic images despite the same input information in both image formats. The use of ROC analysis assisted in the comparison of these two imaging techniques.

The severity of late skin damage related to fraction size in women treated by radiotherapy after mastectomy

A retrospective study has been undertaken to test the NSD formula as a predictor of isoeffective schedules in women treated after mastectomy by parasternal radiotherapy using fraction sizes of 2-3 Gy. Forty three women were identified who have been treated on the same orthovoltage unit 8-18 years previously and the severity of overall skin changes and telangiectasia were assessed by three observers using a 4-point categorical scale. At each level of skin damage, radiotherapy schedules delivered using fraction sizes of 250 R or 300 R were associated with lower TDF values than schedules using 225 R fraction. The difference between TDF factors for isoeffective regimes using small (225 R) and large (250 R and 300 R) fraction sizes is highly significant for both overall skin damage and telangiectasia (p = 0.004 by rank sum test). Care should be exercised when using current empirical formulae to calculate regimes isoeffective for late skin damage, even when modest changes in fraction size from 2 to 3 Gy are contemplated.