Relationship between onset of pain relief and patient satisfaction with fentanyl pectin nasal spray for breakthrough pain in cancer.

BACKGROUND: Satisfaction with pain relief in patients with breakthrough pain in cancer (BTPc) has typically been assessed by overall efficacy without consideration of the rapidity of that response. OBJECTIVE: To determine the relationship between speed of onset of pain relief and patient satisfaction for treated BTPc episodes overall and for individual treatments. DESIGN: Pooled data from two randomized, double-blinded crossover studies. SETTING/SUBJECTS: Patients having 1-4 BTPc episodes per day on ≥60 mg/day oral morphine or equivalent. Episodes treated with fentanyl pectin nasal spray (FPNS; 100-800 µg), immediate-release morphine sulfate (IRMS), or placebo. MEASUREMENTS: Pain intensity was measured on an 11-point scale (5-60 minutes posttreatment); satisfaction was measured on a 4-point scale (30 and 60 minutes). The primary analysis assessed the overall relationship of time to onset of pain relief (pain intensity difference [PID]≥1) or time to clinically meaningfully reduction in pain (PID≥2) versus patient satisfaction and overall pain intensity (summed pain intensity difference at 30 [SPID30] and 60 minutes [SPID60]) assessed by analysis of variance (ANOVA). A secondary analysis assessed whether satisfaction was different between treatments using a within-patient comparison. RESULTS: Eight hundred thirty-one FPNS-treated, 368 IRMS-treated, and 200 placebo-treated episodes were analyzed. Overall, within the pool there was a statistically significant relationship between time to onset of pain relief (PID≥1 and PID≥2) and patient satisfaction (both speed of relief and overall) at 30 and 60 minutes (p<0.001); this relationship was also true within individual treatment groups (p<0.01). Similar results were found for overall pain intensity reduction. When treatment groups were compared using within-patient data, FPNS provided earlier onset of pain relief than IRMS or placebo (p<0.05), which translated into better satisfaction at 60 minutes (p<0.01). CONCLUSIONS: Earlier onset of pain relief resulted in greater patient satisfaction and overall relief of pain; between-treatment comparisons showed that FPNS provided earlier pain relief and greater satisfaction than IRMS or placebo.

An analysis of the variability of breakthrough pain intensity in patients with cancer.

BACKGROUND: The management of breakthrough pain in patients with cancer (BTPc) generally includes an initial titration of breakthrough pain medication to an effective dose, followed by the use of that dose in all subsequent episodes. This strategy presumes that an individual patient has a degree of consistency of pain during repeat episodes; however, that presumption has not been formally assessed. OBJECTIVE: To examine the variation in pain intensity of BTPc episodes within individual patients and across patients. METHODS: Data were pooled from 2 randomized, double-blind, crossover studies that used fentanyl pectin nasal spray (FPNS) vs comparator to relieve BTPc. Eligible patients were adults with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and adequately controlled background pain. The FPNS dose was titrated prior to a double-blind treatment consisting of 10 episodes. Pain intensity was reported on an 11-point numeric scale in which 0 = no pain and 10 = worst possible pain. Inter- and intrapatient variabilities of baseline pain intensity scores per episode were analyzed by analysis of covariance via a mixed-effect model. The influences of demographics and ECOG grade at study entry were assessed. RESULTS: Mean baseline pain intensity score was 7.3 (standard deviation, 1.76; range, 2-10) across 1,399 BTPc episodes in 152 patients. The interpatient variability of baseline pain intensity scores was 75.96%; intrapatient variability was 20.64%. Fixed terms for demographics and ECOG grade did not significantly influence baseline pain intensity score (≤ 5% level). LIMITATIONS: This was a post hoc analysis. CONCLUSIONS: Baseline pain intensity scores during episodes of BTPc vary widely between patients, but vary little within individual patients; this supports the use of a consistent maintenance dosage of analgesia for BTPc, once it has been titrated to an effective dose. FUNDING/SUPPORT: The study was funded by Archimedes Development Ltd.

Nationwide linkage analysis in Scotland-Has mortality following hospital admission for Crohn's disease changed in the early 21st century?

BACKGROUND: National Scottish data were used to compare 3-year mortality in patients hospitalized for Crohn's disease (CD) between 1998-2000 and 2007-2009. METHODS: The linked Scottish Morbidity Records database was used to identify patients admitted with CD during two periods: Period 1 (1998-2000) and Period 2 (2007-2009). 3-year mortality and standardized mortality ratio (SMR) were determined and multivariable logistic regression analysis of associated factors was performed. Mortality was determined following four admission types: surgery-elective, surgery-emergency, medical-elective and medical-emergency. 3-year mortality was compared between study periods using age-standardized rates. RESULTS: The number of patients per 100,000 population hospitalized with CD per year was unchanged (15.7 [Period 1]; 14.4 [Period 2]). Overall crude and adjusted 3-year mortality rates were also unchanged (crude mortality 9.0%-9.1%, adjusted mortality odds ratio [OR]=0.87, 95% confidence interval [CI] 0.65-1.17; p=0.36). The adjusted 3-year mortality increased following elective surgery (Period 1: 1/303 [0.3%]; Period 2: 9/261 [3.4%]); OR=13.5 [CI 1.66-109.99]) and decreased following emergency medical admission (Period 1: 99/779 [12.7%]; Period 2:86/802 [10.7%]; OR=0.68 [CI 0.47-0.97]). Directly age-standardized mortality rates were similar (Period 1:338/10,000 person years [CI 282-394]; Period 2:333/10,000 person years [CI 276-390], p=0.2). On multivariable regression, age, deprivation status, comorbidity and the length of hospital stay were associated with mortality in both periods. High 3-year mortality was observed during both periods in patients between 50 and 64years (Period 1: 33/298 [11.1%, SMR=4.8 [CI 3.44-6.63], Period 2: 33/296 [11.1%, SMR=5.9 [4.14-8.22]) and over 65years(Period 1: 94/275 [34.2%, SMR=2.78 [CI 2.42-3.62], Period 2: 78/251 [31.1%, SMR=3.31 [2.64-4.11]). CONCLUSION: Nationwide linkage data demonstrate that overall 3-year mortality after hospitalization for CD is high, especially in patients over 50years, and has not altered between the time periods 1998-2000 and 2007-2009.

Adhesions after abdominal surgery in children.

PURPOSE: The objective of this study is to quantify the overall burden (operative and nonoperative) of small bowel obstruction caused by adhesions after laparotomy in children. METHODS: Data from the Scottish National Health Service Medical Record Linkage database were used to assess risk of an adhesion-related readmission in the 5 years after open abdominal surgery in children and adolescents younger than 16 years from April 1996 to March 1997. RESULTS: A total of 1581 children underwent abdominal surgery (ie, from duodenum downward). Patients undergoing surgery on the ileum had the highest risk of readmission because of adhesions in the subsequent 5 years after surgery (9.2%)--formation/closure of ileostomy had the greatest risk (25%); 6.5% of children were readmitted after general laparotomy, 4.7% after duodenal surgery, and 2.1% after colonic surgery. The incidence of readmissions was 0.3% after appendicectomy. The overall readmission rate was 5.3% (if appendicectomy was excluded) and 1.1% (if appendicectomy was included). CONCLUSION: This population-based study has demonstrated that children have a high incidence of readmissions owing to adhesions after lower abdominal surgery. The risks are related to the site and the type of the original surgery. The risk of further readmissions was highest in the first year but continued with time. The data enable surgeons to target antiadhesion strategies at procedures that lead to a high risk of adhesions.

Population-based analysis of the risk of adhesion-related readmissions after abdominal surgery in children.

PURPOSE: The aim of this study was to quantify the risk of adhesion-related readmissions after abdominal surgery in children. METHODS: This was a population-based study. One thousand five hundred eighty-one children younger than 16 years underwent laparotomy in 1996. Patients were identified from the Scottish Morbidity Records database and followed up for 4 years. RESULTS: In children younger than 5 years, 4.2% had a readmission "directly" owing to adhesions. In children younger than 16 years, 1.1% had a readmission directly owing to adhesions. The highest risk of readmission followed surgery on the small intestine (9.3%), followed by abdominal wall surgery (5.8%), duodenal surgery (2.6%), colonic surgery (2.1%), and appendicectomy (0.3%). 55% of all readmissions occurred in the first year. CONCLUSION: There was no difference in readmission rates between younger and older children when comparing the organ on which surgery was initially performed. The highest readmission rate followed small intestinal surgery and the lowest followed appendicectomy. The risk of readmission was highest in the first year.