Musculoskeletal pain characteristics associated with lower balance confidence in community-dwelling older adults

Objective: To determine whether musculoskeletal pain (pain severity and number of chronic pain sites; single or multisite) is associated with balance confidence over and above previously established risk factors. Design: Cross-sectional study. Setting: Ten community sites (five day centres, two sheltered housing schemes and three community ‘clubs’) in the UK. Participants: Two hundred and eighty-nine community-dwelling older adults [response rate 72%, mean age 78 (standard deviation 8) years, 67% female] completed the study assessment. Eligibility criteria were as follows: living in the community; aged ≥60 years; able to walk ≥10 m; able to communicate in English; and no cognitive (e.g. dementia), neurological or mental health conditions. Interventions: Not applicable. Main outcome measure: Balance confidence as measured by the 16-item Activities Balance Confidence (ABC) scale (lower scores indicate less confidence). Results: One hundred and fifty participants had at least one site of chronic musculoskeletal pain (52%), and the remaining 139 (48%) participants did not report chronic musculoskeletal pain. Older people with chronic musculoskeletal pain had significantly lower scores on the ABC scale compared with those without chronic musculoskeletal pain (mean 48.3 vs 71.3, P < 0.001). After adjustment for established risk factors, two separate hierarchical regression models demonstrated that both pain severity (β=-0.106, P = 0.029) and number of chronic musculoskeletal pain sites (β=-0.98, P = 0.023) were significantly associated with lower balance confidence. Conclusion: Both pain severity and number of chronic pain sites (particularly multisite pain) are associated with lower balance confidence in community-dwelling older adults. Further research is needed to target pain symptoms and balance confidence in relation to fall risk in older adults with chronic musculoskeletal pain

Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients’ health-related quality of life and productivity

Background Although psoriatic arthritis is complex and involves multiple domains, recent advances in treatments have made remission or near-remission of most symptoms a potentially achievable goal for many patients. We sought to evaluate whether achieving minimal disease activity (MDA) criteria represented meaningful improvement from the patient perspective. Methods Data were combined from two randomized, multinational, 24 week clinical studies of ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, in biological drug-naïve or experienced adults. MDA required 5 of 7 of: tender joint count ≤1; swollen joint count ≤1; Psoriasis Area and Severity Index total score ≤ 1 or body surface area ≤ 3%; patient’s assessment of pain visual analogue scale (VAS) ≤15; patient’s global assessment of disease activity VAS ≤20; Health Assessment Questionnaire Disability Index ≤0.5; and tender entheseal points ≤ 1. MDA responders and non-responders were compared for mean change from baseline on the 36-Item Short Form Health Survey (SF-36), European Quality of Life 5 Dimension 5 Level Health Questionnaire (EQ-5D-5 L); EQ-5D-5 L VAS; and Work Productivity and Activity Impairment–Specific Health Problem (WPAI-SHP) questionnaire. Results MDA responders had significantly greater improvements versus non-responders in each SF-36 domain and in the SF-36 physical summary score; improvements were also greater in the EQ-5D-5 L and EQ-5D-5 L VAS, and in 3 of the 4 WPAI-SHP domains. MDA responders were more likely to achieve minimal clinically important differences than non-responders. Conclusion These findings support MDA response as being strongly associated with achieving improved disease status based on measures of patient reported health-related quality of life and productivity. Trial registration SPIRIT-P1, NCT01695239, First Posted: September 27, 2012; and SPIRIT-P2, NCT02349295, First Posted: January 28, 2015

Psychometric Evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, Responsiveness, and Clinical Meaningfulness

This study evaluated the psychometric properties of the FCSI-9 administered to metastatic colorectal cancer patients in a phase III clinical trial. The results provide preliminary evidence to suggest that the FCSI-9, a brief, symptom-specific measure, is reliable, valid, and responsive in this population

Preferences of people with diabetes for diabetic retinopathy screening: a discrete Choice experiment

Aims The ever-increasing prevalence of diabetes places pressure on the provision of diabetic retinopathy screening services. As the first study of its kind, we aimed to determine preferences for diabetic retinopathy screening in people with diabetes and to examine the trade-offs between frequency of screening and other service attributes. Methods A questionnaire including a discrete choice experiment was administered to people (n = 198) attending diabetic retinopathy screening at eight clinics across Wales, United Kingdom. The discrete choice experiment contained eight pairwise choices in which screening provision was described by five attributes: frequency of screening; travel time; results time; ability of screening to detect other changes; and explanation of results. Data were analysed using logistic regression techniques. Results We gained a response rate of 86.4% from the 198 questionnaires administered at clinics; 160 complete responses were analysed. Respondents valued four out of the five attributes [ability of screening to detect other changes (P = 0.000), explanation of results (P = 0.024), frequency of screening (P = 0.000) and travel time (P = 0.007)]. Results time was insignificant (P = 0.122). Respondents were willing to wait an additional 12, 2 and 1 month between screening tests to have a test that was able to detect additional changes, to have their results explained in person rather than by letter and to have a 15-min reduction in travel time, respectively. Conclusions Respondents were willing to accept a longer screening interval, as long as preferences for other attributes of service provision (ability of screening to detect other changes, explanation of results and travel time) were made available

"Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study.

OBJECTIVE: To evaluate the 16- and 52-week effectiveness of add-on omalizumab treatment under real-life heterogeneity in patients, settings, and physicians in an open-label, multicenter, pharmaco-epidemiologic study of patients with severe persistent allergic asthma in Belgium. METHODS: Effectiveness outcomes included improvement in 2005 global initiative for asthma (GINA) classification, physician-rated global evaluation of treatment effectiveness (GETE), quality of life (Juniper asthma-related quality of life (AQLQ) and European quality of life questionnaire 5 dimensions (EQ-5D)), and severe asthma exacerbations. Patients studied included both intent-to-treat and per-protocol populations. RESULTS: The sample (n=158) had a mean age of 48.17+/-17.18 years, and a slight majority were female (53.8%). Despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists, all patients experienced frequent symptoms and had exacerbations in the past year. At 16 weeks, >82% had good/excellent GETE (P values 82% had an improvement in total AQLQ scores of > or =0.5 points (P91% were severe exacerbation-free (P72% had a good/excellent GETE rating (P84% had improvements in total AQLQ score of > or =0.5 points (P56% had minimally important improvements in EQ-5D utility scores (P=0.012), and >65% were severe exacerbation-free (P<0.001). Significant reductions in healthcare utilization compared to the one year prior to treatment were noted. CONCLUSION: The PERSIST study shows better physician-rated effectiveness, greater improvements in quality of life, greater reductions in exacerbation rates, and greater reductions in healthcare utilization than previously reported in efficacy studies. Under real-life conditions, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma

The TTO method and procedural invariance

In a pilot study we investigate whether the inferences we draw about people's preferences towards health care treatments are altered if we vary the procedure that is used to elicit these preferences. In a conventional time trade-off (TTO) question, respondents express their preferences towards treatment by comparing a period of ill-health with a shorter period in a higher quality of life. In our less conventional TTO question, we vary the procedure by asking respondents their preferences towards treatment by comparing a period of ill-health with a longer period in a lower quality of life. The quantitative data are equivocal about whether preferences for treatment differ between the conventional and unconventional questions. The qualitative data support the notion of contrasting issues in the questions that involve prolonging time in a lower quality of life and appear to account for a failure to find quantitative differences in all of the questions. Copyright © 2002 John Wiley & Sons, Ltd.

Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines

Background: Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. Objectives: To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. Design: Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. Setting: Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. Participants: People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. Inclusion criteria: Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. Exclusion criteria: Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing greater distress than GAD, significant dependence on alcohol or illicit drugs, comorbid psychotic disorder, received antidepressants in past 8 weeks or high-intensity psychological therapy in previous 6 months and any contraindications to treatment with sertraline. Randomisation: Consenting eligible participants randomised via an independent, web-based, computerised system. Interventions: (1) The SSRI sertraline prescribed in therapeutic doses by the patient’s general practitioner for 12 months and (2) 14 (± 2) CBT sessions delivered by high-intensity IAPT psychological therapists in accordance with a standardised manual designed for GAD. Main outcome measures: The primary outcome was the Hospital Anxiety and Depression Scale – Anxiety component at 12 months. Secondary outcomes included measures of depression, social functioning, comorbid anxiety disorders, patient satisfaction and economic evaluation, collected by postal self-completion questionnaires. Results: Only seven internal pilot participants were recruited against a target of 40 participants at 7 months. Far fewer potential participants were identified than anticipated from IAPT services, probably because PWPs rarely considered GAD the main treatment priority. Of those identified, three-quarters declined participation; the majority (30/45) were reluctant to consider the possibility of randomisation to medication. Limitations: Poor recruitment was the main limiting factor, and the trial closed prematurely. Conclusions: It is unclear how much of the recruitment difficulty was a result of conducting the trial within a psychological therapy service and how much was possibly a result of difficulty identifying participants with primary GAD. Future work: It may be easier to answer this important question by recruiting people from primary care rather than from those already engaged in a psychological treatment service. Trial registration: Current Controlled Trials ISCRTN14845583. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 45. See the NIHR Journals Library website for further project information