Search

Objective The study aims to evaluate the ability of self-management programmes to change the healthcare-seeking behaviours of people with Chronic Obstructive Pulmonary Disease (COPD), and any associations between programme design and outcomes. Methods A systematic search of the literature returned randomised controlled trials of SMPs for COPD. Change in healthcare utilisation was the primary outcome measure. Programme design was analysed using the Theoretical Domains Framework (TDF). Results A total of 26 papers described 19 SMPs. The most common utilisation outcome was hospitalisation (n = 22). Of these, 5 showed a significant decrease. Two theoretical domains were evidenced in all programmes: skills and behavioural regulation. All programmes evidenced at least 5 domains. However, there was no clear association between TDF domains and utilisation. Overall, study quality was moderate to poor. Conclusion This review highlights the need for more alignment in the goals, design, and evaluation of SMPs. Specifically, the TDF could be used to guide programme design and evaluation in future. Practice implications Practices have a reasonable expectation that interventions they adopt will provide patient benefit and value for money. Better design and reporting of SMP trials would address their ability to do so.

Objective It is increasingly recognized that patient safety requires heterogeneous insights from a range of stakeholders, yet incident reporting systems in health care still primarily rely on staff perspectives. This paper examines the potential of combining insights from patient complaints and staff incident reports for a more comprehensive understanding of the causes and severity of harm. Methods Using five years of patient complaints and staff incident reporting data at a large multi-site hospital in London (in the United Kingdom), this study conducted retrospective patient-level data linkage to identify overlapping reports. Using a combination of quantitative coding and in-depth qualitative analysis, we then compared level of harm reported, identified descriptions of adjacent events missed by the other party and examined combined narratives of mutually identified events. Results Incidents where complaints and incident reports overlapped (n = 446, reported in 7.6%’ of all complaints and 0.6% of all incident reports) represented a small but critical area of investigation, with significantly higher rates of Serious Incidents and severe harm. Linked complaints described greater harm from safety incidents in 60% of cases, reported many surrounding safety events missed by staff (n = 582), and provided contesting stories of why problems occurred in 46% cases, and complementary accounts in 26% cases. Conclusions This study demonstrates the value of using patient complaints to supplement, test, and challenge staff reports, including to provide greater insight on the many potential factors that may give rise to unsafe care. Accordingly, we propose that a more holistic analysis of critical safety incidents can be achieved through combining heterogeneous data from different viewpoints, such as through the integration of patient complaints and staff incident reporting data.

Bronchiectasis is an increasingly common chronic respiratory disease which requires a high level of patient engagement in self-management. Whilst the need for self-management has been recognised, the knowledge and skills needed to do so— and the extent to which patients possess these—has not been well-specified. On one hand, understanding the gaps in people’s knowledge and skills can enable better targeting of self-management supports. On the other, clarity about what they do know can increase patients’ confidence to self-manage. This study aims to develop an assessment of patients’ ability to self-manage effectively, through a consensus-building process with patients, clinicians and policymakers. The study employs a modified, online three-round Delphi to solicit the opinions of patients, clinicians, and policymakers (N = 30) with experience of bronchiectasis. The first round seeks consensus on the content domains for an assessment of bronchiectasis self-management ability. Subsequent rounds propose and refine multiple-choice assessment items to address the agreed domains. A group of ten clinicians, ten patients and ten policymakers provide both qualitative and quantitative feedback. Consensus is determined using content validity ratios. Qualitative feedback is analysed using the summative content analysis method. Overarching domains are General Health Knowledge, Bronchiectasis-Specific Knowledge, Symptom Management, Communication, and Addressing Deterioration, each with two sub-domains. A final assessment tool of 20 items contains two items addressing each sub-domain. This study establishes that there is broad consensus about the knowledge and skills required to self-manage bronchiectasis effectively, across stakeholder groups. The output of the study is an assessment tool that can be used by patients and their healthcare providers to guide the provision of self-management education, opportunities, and support.

Highlights • Self-management programmes are a popular way to engage patients in their own care. • Inconclusive results stem from inconsistency in study conditions, design, and reporting. • Behaviour change theories can identify appropriate outcome measures for evaluation. • Programmes should be developed with theory and patient-centricity in mind., Objective The study aims to evaluate the ability of self-management programmes to change the healthcare-seeking behaviours of people with Chronic Obstructive Pulmonary Disease (COPD), and any associations between programme design and outcomes. Methods A systematic search of the literature returned randomised controlled trials of SMPs for COPD. Change in healthcare utilisation was the primary outcome measure. Programme design was analysed using the Theoretical Domains Framework (TDF). Results A total of 26 papers described 19 SMPs. The most common utilisation outcome was hospitalisation (n = 22). Of these, 5 showed a significant decrease. Two theoretical domains were evidenced in all programmes: skills and behavioural regulation. All programmes evidenced at least 5 domains. However, there was no clear association between TDF domains and utilisation. Overall, study quality was moderate to poor. Conclusion This review highlights the need for more alignment in the goals, design, and evaluation of SMPs. Specifically, the TDF could be used to guide programme design and evaluation in future. Practice implications Practices have a reasonable expectation that interventions they adopt will provide patient benefit and value for money. Better design and reporting of SMP trials would address their ability to do so.

Importance Drugs treating serious or life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine whether these effects translate to clinical improvements. Objective To characterize preapproval and confirmatory clinical trials of drugs granted accelerated approval. Design and Setting Publicly available FDA documents were reviewed to identify the preapproval trials leading to accelerated approval between 2009 and 2013. Information on the status and findings of required confirmatory studies was extracted from the FDA’s database of postmarketing requirements and commitments, ClinicalTrials.gov, and matched peer-reviewed publications. Follow-up ended on April 7, 2017. Exposures Granting of accelerated approval. Main Outcomes and Measures Characteristics of preapproval and confirmatory studies were compared in terms of study design features (randomization, blinding, comparator, primary end point). Subsequent regulatory decisions and estimated time between accelerated approval and fulfillment of regulatory requirements were summarized. Results The FDA granted accelerated approval to 22 drugs for 24 indications (19 for indications involving cancer treatment) between 2009 and 2013. A total of 30 preapproval studies supported the 24 indications. The median number of participants enrolled in the preapproval studies was 132 (interquartile range, 89-224). Eight studies (27%) included fewer than 100 participants and 20 (67%) included fewer than 200. At a minimum 3 years of follow-up, 19 of 38 (50%) required confirmatory studies were completed, including 18 published reports. Twenty-five of the 38 (66%) examined clinical efficacy, 7 (18%) evaluated longer follow-up, and 6 (16%) focused on safety The proportion of studies with randomized designs did not differ before and after accelerated approval (12/30 [40%] vs 10/18 [56%]; difference, 16%; 95% CI, −15% to 46%;P = .31). Postapproval requirements were completed and demonstrated efficacy in 10 of 24 indications (42%) on the basis of trials that evaluated surrogate measures. Among the 14 of 24 indications (58%) that had not yet completed all requirements, at least 1 of the confirmatory studies failed to demonstrate clinical benefit in 2 (8%), were terminated in 2 (8%), and were delayed by more than 1 year in 3 (13%). Studies were progressing according to target timelines for the remaining 7 indications (29%). Clinical benefit had not yet been confirmed for 8 indications that had been initially approved 5 or more years prior. Conclusions and Relevance Among 22 drugs with 24 indications granted accelerated approval by the FDA in 2009-2013, efficacy was often confirmed in postapproval trials a minimum of 3 years after approval, although confirmatory trials and preapproval trials had similar design elements, including reliance on surrogate measures as outcomes.