Antony Veale

Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St Georges Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD. Lung function/symptomatic benefits of daily tiotropium+olodaterol fixed-dose combination in moderate-very severe COPD http://ow.ly/DIKiY

Printed patient education interventions to facilitate shared management of chronic disease: a literature review

Abstract

Smoking termination opportunity for in patients (STOP): superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 12-month randomised controlled trial for inpatients

Rationale Smoking cessation interventions in outpatient settings have been demonstrated to be cost effective. Given this evidence, we aimed to evaluate the effectiveness of varenicline tartrate plus Quitline-counselling compared with Quitline-counselling alone when initiated in the inpatient setting. Methods Adult patients (18–75 years) admitted with a smoking-related illness to three hospitals, were randomised to receive either 12-weeks of varenicline tartrate plus Quitline-counselling, (n=196) or Quitline-counselling alone, (n=196), with 12-months follow-up. Results For the primary analysis population (intention-to-treat), the proportion of subjects who remained continuously abstinent were significantly greater in the varenicline plus counselling arm (31.1%, n=61) compared with counselling alone (21.4%, n=42; RR 1.45, 95% CI 1.03 to 2.03, p=0.03). Conclusions The combined use of varenicline plus counselling when initiated in the inpatient setting has produced a sustained smoking cessation benefit at 12-months follow-up, indicating a successful opportunistic treatment for smokers admitted with smoking related illnesses. Trial registration http://www.clinicaltrials.gov/ ClinicalTrials.gov identification number: NCT01141855.

Patient education programs - can they improve outcomes in COPD?

It is important to assess the effectiveness of patient education programs for people with COPD (chronic obstructive pulmonary disease) to ensure that limited health resources are being spent effectively. We aimed to assess the effectiveness of programs reported to date, and to look for ways of designing more effective programs. COPD patient education to date has produced little demonstrated success, but studies, education programs and study reports all show limitations. To demonstrate links between outcomes and patient education program components, there is a need for more trials which combine process and outcome evaluation. Programs to date have relied too heavily on the provision of medical information to patients. Programs which also aim to improve disease management self-efficacy hold promise but further determinants of health behavior should be included also, as part of more systematic program design. Program components need to be clearly described and the rationale for their use justified in trial reports. This will produce an evidence base that should show what role education programs can play in improving outcomes, and inform the development of more effective programs.

Providing patients with reviews of evidence about COPD treatments: a controlled trial of outcomes

Studies in many countries have identified gaps between what is known from research evidence and what is done in clinical practice. Merely making research evidence available to practitioners does not cause much change in their behaviour, and researchers are now looking for more effective ways to improve the implementation of evidence. We report outcomes at three months of a parallel group trial of an evidence based patient manual designed to improve implementation of evidence by the patient’s doctors. The patient manual was produced with extensive patient and professional input. It contained summaries of the evidence for treatments used in COPD (chronic obstructive pulmonary disease) and prompted discussion of evidence with doctors. Participants in the intervention arm of the trial (n - 125) were supplied with the manual and participants in the control arm (n - 124) were supplied with a pamphlet about COPD produced by the Australian Lung Foundation. The primary outcome measure (rates of current influenza vaccination and bone density testing) was an indicator of evidence based management of COPD. Secondary outcomes were quality of life (mastery component), satisfaction with information, communication with usual doctor, and anxiety. At three months no pattern of benefit in outcome measures was found for either group. Process measures showed high levels of personal use of the manual but progression to conversations with doctors for fewer than half of participants, and little treatment change. The findings highlight the difficulties of promoting changes in health behaviour and show that even when all stakeholders are consulted success is not guaranteed. Further research is required to identify those patients most likely to use manuals such as the one reported here, and how to make patient mediated interventions more effective for a greater proportion of the target population.

Eformoterol n-of-1 trials in chronic obstructive pulmonary disease poorly reversible to salbutamol.

Aims: Benefits of long acting beta 2 agonists are unclear for severe chronic obstructive pulmonary disease (COPD) patients with poor response to short acting bronchodilators. We aimed to evaluate 1) effects of eformoterol in such patients using a ‘n-of-1’ double crossover study design, and 2) aggregate data as a double-blind, double crossover randomized control trial. Methods: Subjects with forced expiratory volume in one second (FEV1) < 60% predicted, and poor response to short acting bronchodilators were studied six times over 18 weeks. During that time they were prescribed four weeks of either eformoterol or placebo, followed by the alternate, and then a second crossover. Four-weekly measures included six minute walk distance (6MWD), FEV1, previous two weeks of symptoms, and chronic respiratory questionnaire (CRQ) including treatment goal items. Results: Of 27 original subjects (21 male, mean age of 70 years, five smokers, mean prebronchodilator FEV1, 36% predicted), one subject had clinically significant concordant improvement in the CRQ dyspnoea domain and 6MWD (by 51 metres), but not for other outcomes. There were no concordant improvements in any other subjects. Aggregate double crossover data analysis demonstrated no improvement in any outcome measures. Conclusions: The ‘n-of-1’ study design and aggregate data analysis demonstrated lack of benefit from eformoterol in COPD patients with poor response to short acting bronchodilators.

Safety of Varenicline Tartrate and Counseling Versus Counseling Alone for Smoking Cessation: A Randomized Controlled Trial for Inpatients (STOP Study)

INTRODUCTION Inpatient medical settings offer an opportunistic environment for initiating smoking cessation interventions to patients reflecting on their health. Current evidence has shown the superior efficacy of varenicline tartrate (VT) for smoking cessation compared with other tobacco cessation therapies; however, recent evidence also has highlighted concerns about the safety and tolerability of VT. Given these apprehensions, we aimed to evaluate the safety and effectiveness of VT plus quitline-counseling compared to quitline-counseling alone in the inpatient medical setting. METHODS Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to 3 hospitals were randomized to receive either 12 weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice daily) plus quitline-counseling (VT+C), (n = 196) or quitline-counseling alone (n = 196). RESULTS VT was well tolerated in the inpatient setting among subjects admitted with acute smoking-related illnesses (mean age 52.8±2.89 and 53.7±2.77 years in the VT+C and counseling alone groups, respectively). The most common self-reported adverse event during the 12-week treatment phase was nausea (16.3% in the VT+C group compared with 1.5% in the counseling alone group). Thirteen deaths occurred during the study period (n = 6 were in the VT+C arm compared with n = 7 in the counseling alone arm). All of these subjects had known comorbidities or developed underlying comorbidities. CONCLUSIONS VT appears to be a safe and well-tolerated opportunistic treatment for inpatient smokers who have related chronic disease. Based on the proven efficacy of varenicline from outpatient studies and our recent inpatient evidence, we suggest it be considered as part of standard care in the hospital setting.

Providing reviews of evidence to COPD patients: controlled prospective 12-month trial.

The aim of this study was to evaluate a novel patient-held manual designed to reduce the evidence–practice gap in chronic obstructive pulmonary disease (COPD). The intervention manual contained summaries of research evidence. It was developed using current best practice for patient information materials and designed to cause discussion of evidence between patient and doctor. A controlled before-and-after study was employed in two similar but geographically separate regions of metropolitan Adelaide, South Australia. Participants had moderate to severe COPD, with 249 included at baseline and 201 completing the study. Evidence-based COPD management was measured using an indicator with three components: rates of influenza vaccination, bone density testing, and pulmonary rehabilitation. A survey of behavioral steps leading to practice change was conducted with the trial. Analysis, by median split of socioeconomic disadvantage, showed significant difference between study arms for only one component of the indicator of evidence-based practice, enrolment in pulmonary rehabilitation and only for the most socioeconomically disadvantaged stratum. For both socioeconomic strata, more intervention participants than control participants reported remembering being given the information material, reading part or all, and finding it very or quite helpful. Other significant differences were restricted to the stratum of greatest socioeconomic disadvantage: reading all of the material, learning from it, referring back, and talking to a doctor about a topic from the material. Above 90% of all participants who received the manual reported reading from it, 42% reported discussing topics with a doctor, but only 10% reported treatment change attributable to the manual. We have found that people with COPD will read an evidence manual developed using current best practice. However, the study demonstrated improvement for only one of the three components of an indicator of evidence-based disease management for only the most socioeconomically disadvantaged stratum of participants. Future interventions should be designed to better translate reading uptake into evidence-based disease management.

Providing reviews of evidence to COPD patients: qualitative study of barriers and facilitating factors to patient-mediated practice change

This study aimed to identify barriers and facilitating factors to people with COPD performing the following actions: (a) reading a manual that contained summaries of evidence on treatments used in chronic obstructive pulmonary disease (COPD) and (b) at a medical consultation, asking questions that were provided in the manual and were designed to prompt doctors to review current treatments in the light of evidence. The manual was developed using current best practice and was designed to facilitate reading and discussion with doctors. In-depth interviews were held with patients who had received the manual. Of 125 intervention participants from a controlled clinical trial of the manual, 16 were interviewed in their homes in and around Adelaide, South Australia. Plain language writing and a simple layout facilitated reading of the manual by participants. Where the content matched the interests of participants this also facilitated reading. On the other hand, some participants showed limited interest in the evidence summaries. Participant comments indicated that they did not see it as possible or acceptable for patients to master research evidence or initiate discussions of evidence with doctors. These appeared to be the main barriers to effectiveness of the manual. If evidence summaries for patients are to be used in disease management, they should be understandable and relevant to patients and provide a basis for discussion between patients and doctors. Work is now needed so that we can both present evidence summaries in a way that is relevant to patients and reduce the barriers to patient-initiated discussions of evidence.

Smoking cessation and tobacco prevention in Indigenous populations

This article systematically reviews 91 smoking cessation and tobacco prevention studies tailored for Indigenous populations around the world, with a...