Pain relief and tolerability balance of immediate release tapentadol or oxycodone treatment for patients with moderate to severe osteoarthritis or low back pain.

PURPOSE: Opioid treatment effectiveness may be best compared using definitions of treatment response, which combine measures assessing pain reduction and the occurrence of adverse events (AEs). This analysis of data from two phase III clinical trials was conducted to examine the pain relief and tolerability (PRT) balance of immediate release (IR) tapentadol and oxycodone in patients with moderate to severe osteoarthritis (OA) or low back pain. METHODS: This was a post hoc analysis of two multicenter, randomized, double-blind studies (10-day and 90-day) that evaluated the efficacy and safety of tapentadol IR in patients with moderate-severe OA pain. PRT was defined as adequate pain reduction (30% or 50% pain intensity improvement from baseline) and no gastrointestinal AE or other type of treatment-emergent AE. The percentage of patients and mean number of days per patient meeting the PRT criteria were summarized. RESULTS: In the 10-day trial, the percentages of patients meeting PRT criteria (30% reduction) for both tapentadol groups were consistently above that for oxycodone 10 mg, although only significantly different for the 50 mg formulation. The mean number of days per patient meeting the PRT criteria was 3.7, 3.2, and 2.3 days for tapentadol 50 mg, 75 mg and oxycodone 10 mg, respectively. No significant difference between the groups was observed using the 50% pain reduction criterion. For the 90-day trial, using multiple definitions, tapentadol IR showed a significantly higher proportion of days meeting PRT criteria. CONCLUSION: Pain reduction and tolerability are both important attributes of an effective analgesic treatment. Based on data from two trials, tapentadol IR produced an improved PRT balance compared with oxycodone IR.

Association of gestational age and growth measures at birth with infection-related admissions to hospital throughout childhood: a population-based, data-linkage study from Western Australia.

BACKGROUND: Reduced gestational age and low birthweight are associated with an increased risk of neonatal infections. However, the long-term risk of infection, especially in late preterm infants or those at near-normal birthweight, is unknown. We estimated whether rates of infection-related admissions to hospital for children in Western Australia were associated with age, gestational age, birthweight, and birth length. METHODS: We did a population-based, data-linkage study using total-linked, registry data from the Western Australia Birth Register of all liveborn, non-Indigenous Australian singleton births recorded from Jan 1, 1980, to Dec 31, 2010. We followed up individuals from birth-related hospital discharge to age 18 years, death, or end of 2010, and linked to data about subsequent admissions to hospital or death registrations. Gestational age was assessed from both the last menstrual period and from estimates based on ultrasonography. We categorised birthweight by 500 g bands and birth length by 5 cm bands, and approximated the reference ranges for both to the 50th percentile. Because size at birth and gestational age are strongly associated, we calculated Z scores for gestational-specific and sex-specific birthweight, birth length, and ponderal index. Our primary outcomes were the number and type of infection-related admissions to hospital. We used multilevel negative binomial regression to generate rate ratios (RR) for such admissions, identified by codes from the International Classification of Diseases, versions 9 and 10-AM. We adjusted the RRs for maternal age at delivery, birth year, birth season, parity, sex, 5-min Apgar score, delivery method, socioeconomic status, and bronchopulmonary dysplasia. FINDINGS: Of 719 311 liveborn singletons included in the analysis and followed up for 8 824 093 person-years, 365 867 infection-related admissions to hospital occurred for 213 683 (30%) children. Of the 719 311 children included in the analysis, 137 124 (19%) had one infection-related admission to hospital, 43 796 (6%) had two, 16 679 (2%) had three, and 16 084 (2%) had four or more. The 365 867 admissions to hospital included a diagnosis of infection of the upper respiratory tract for 174 653 (48%), the lower respiratory tract for 74 297 (20%), the gastrointestinal tract for 44 755 (12%), and a viral infection for 37 213 (10%). Infection-related rates of admissions to hospital increased by 12% for each week reduction in gestational age less than 39-40 weeks (RR 1·12, 95% CI 1·12-1·13), by 19% for each 500 g reduction in birthweight less than 3000-3500 g (1·19, 1·18-1·21), and by 41% for each 5 cm reduction in birth length less than 45-50 cm (1·41, 1·38-1·45). Gestational age-specific and sex-specific birthweight Z scores lower than the 25th to 50th percentile and birth length Z scores lower than the 10th to 25th percentile were associated with increased rates of infection-related admissions to hospital (eg, 1st-5th percentile RR 1·15, 95% CI 1·12-1·19, and 1·11, 1·07-1·14, respectively). Ponderal index Z scores lower than the 25th to 50th percentile were also associated with increased rates of infection-related admissions (eg, 1st-5th percentile RR 1·08, 95% CI 1·04-1·12). A gestational age of 41 weeks or later, a birthweight or birth length Z score above the 50th percentile, or a ponderal index Z score between the 75th and 95th percentile, were associated with modestly reduced rates of infection-related admissions to hospital. INTERPRETATION: Children who were born with reduced gestational age, birthweight, and birth length have persistently increased rates of infection-related admissions to hospital until age 18 years. Pregnancy outcomes should be optimised to prevent infection occurring in this population, especially in resource-limited settings where suboptimum intrauterine growth and moderate prematurity are common. FUNDING: Australian National Health and Medical Research Council.

Community participation for girls and women living with Rett syndrome.

OBJECTIVE: To describe the relationships between impairment and contextual factors and community participation for girls and women with Rett syndrome. METHODS: Data was collected from a questionnaire completed in 2009 by families participating in the Australian Rett Syndrome Database (n = 214). Univariate and multivariate logistic regression were used to analyse relationships between impairment, personal and environmental factors and community participation. RESULTS: The mean age of the girls and women was 17.6 years (SD = 7.95, range 3 to 34 years) with 114 (53.3%) girls still at school and 100 (46.7%) women post school. Frequency of activities was influenced by level of walking, community support and maternal education. For girls living at home, participation in activities was associated with greater functional independence and higher levels of maternal education. Participation in recreational (90.1%), physical/skill-based (67.6%) and/or social (70.3%) activities was commonly reported by families, while self-improvement (17.6%) activities were less reported. Younger girls participated in activities mainly with family members and older girls more frequently participated with carers. CONCLUSION: Participation for girls and women with Rett syndrome could be enhanced by stronger local community supports. There are also needs for the implementation of policies that ensure resources are available and accessible by those communities most in need.

Improving access to psychological therapies and older people: findings from the Eastern Region.

BACKGROUND: Evaluations of the Improving Access to Psychological Therapies (IAPT) scheme have not yet focused on minority subgroups. This paper aims to evaluate accessibility, waiting times and clinical outcomes of IAPT for older adults. METHODS: All referrals from six Primary Care Trusts (PCT) in the East of England were used in this analysis. During each session, the therapist recorded information on anxiety symptoms using the Generalised Anxiety Disorder Questionnaire (GAD-7) and depressive symptoms with the Patient Health Questionnaire (PHQ-9). Waiting times, type of referrals and reliable recovery rates were investigated. RESULTS: Older adults accounted for only 4% of all the IAPT referrals made between September 2008 and July 2010 in the Eastern Region. Waiting times for both IAPT assessment and treatment were slightly lower for older adult. In all centres, reliable recovery rates were higher in older adults compared to younger adults post-treatment, however these differences were not significant, with the exception of a difference in anxiety scores (χ(2)(1) = 18.6, p < 0.001). In multivariate analyses, being an older adult was associated with recovery for depression (OR = 1.30, 95% CI 1.10-1.53), anxiety (OR = 1.42, 95% CI 1.21-1.66), and overall recovery (OR = 1.31, 95% CI 1.10-1.54) after adjustment for gender, PCT region, baseline score, maximum treatment step during treatment, dropping out, and number of sessions. CONCLUSIONS: The IAPT services were shown to be beneficial to older patients, however, access to these services in later life has been lower than expected. The service pathway for older populations needs to be better researched in order to eliminate possible obstacles in accessing services.

Comparative effectiveness of cognitive therapies delivered face-to-face or over the telephone: an observational study using propensity methods.

OBJECTIVES: To compare the clinical and cost-effectiveness of face-to-face (FTF) with over-the-telephone (OTT) delivery of low intensity cognitive behavioural therapy. DESIGN: Observational study following SROBE guidelines. Selection effects were controlled using propensity scores. Non-inferiority comparisons assessed effectiveness. SETTING: IAPT (improving access to psychological therapies) services in the East of England. PARTICIPANTS: 39,227 adults referred to IAPT services. Propensity score strata included 4,106 individuals; 147 pairs participated in 1:1 matching. INTERVENTION: Two or more sessions of computerised cognitive behavioural therapy (CBT). MAIN OUTCOME MEASURES: Patient-reported outcomes: Patient Health Questionnaire (PHQ-9) for depression; Generalised Anxiety Disorder questionnaire (GAD-7); Work and Social Adjustment Scale (WSAS). Differences between groups were summarised as standardised effect sizes (ES), adjusted mean differences and minimally important difference for PHQ-9. Cost per session for OTT was compared with FTF. RESULTS: Analysis of covariance controlling for number of assessments, provider site, and baseline PHQ-9, GAD-7 and WSAS indicated statistically significantly greater reductions in scores for OTT treatment with moderate (PHQ-9: ES: 0.14; GAD-7: ES: 0.10) or small (WSAS: ES: 0.03) effect sizes. Non-inferiority in favour of OTT treatment for symptom severity persisted as small to moderate effects for all but individuals with the highest symptom severity. In the most stringent comparison, the one-to-one propensity matching, adjusted mean differences in treatment outcomes indicated non-inferiority between OTT versus FTF treatments for PHQ-9 and GAD-7, whereas the evidence was moderate for WSAS. The per-session cost for OTT was 36.2% lower than FTF. CONCLUSIONS: The clinical effectiveness of low intensity CBT-based interventions delivered OTT was not inferior to those delivered FTF except for people with more severe illness where FTF was superior. This provides evidence for better targeting of therapy, efficiencies for patients, cost savings for services and greater access to psychological therapies for people with common mental disorders.