An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study

BACKGROUND: In comparison with other study designs, randomised trials are regarded as particularly likely to benefit from patient and public involvement (PPI). Using mixed-methods research we investigated PPI from the perspectives of researchers and PPI contributors. METHODS: Randomised trials in receipt of funding from the Health Technology Assessment (HTA) programme between 2006 and 2010 were identified. Funding applications and board and referee comments were obtained and data relevant to PPI extracted. Chief investigators (CIs), PPI contributors and UK Clinical Research Collaboration Registered Clinical Trials Units (RCTUs) were surveyed. Interviews were conducted with researchers and PPI contributors. RESULTS: A total of 111 trials were included. Text relevant to PPI was identified in half of the trials for which the first-stage applications were available, but only one-quarter described PPI within their development. In the second stage of the application, the majority provided some text relevant to PPI, with over half having PPI in their development. Fewer than half of referees commented on PPI, and funding boards rarely provided comments in relation to PPI. Seventy-three per cent (81 of 111) of CIs responded to the survey and 98% (79 of 81) included PPI at some stage in their trial. CIs considered high impact from PPI contributors to occur more frequently in trial setup, with low or no impact being more common during trial conduct, analysis and dissemination. Only one-third of CIs provided PPI contributor contact details but all contributors contacted completed the survey. The majority of contributors felt engaged and valued by the research team. Interviews were conducted with researchers and/or PPI contributors for 28 trials identifying two main influences on perception of PPI impact: whether or not CIs expressed personal goals and plans for PPI; and the quality of their relationship with the PPI contributors. The importance of early engagement was identified, with opportunity for input thereafter limited. Three PPI roles were identified: oversight, managerial and responsive. Oversight roles, as required by funders, were associated with low impact in comparison with responsive or managerial roles. Most researchers could see some value in PPI training for researchers, although those that had received such training themselves expressed concerns about its purpose and evidence base. Training for PPI contributors was considered unnecessary, with conversational approaches preferred, although this did not appear to provide an opportunity for role negotiation. The RCTU survey response rate was 85% (39 of 46). The majority (37 of 39) reported PPI within trials co-ordinated by their unit. Trial characteristics were used by half to determine the approach to PPI. Two-thirds reported recent developments or changes in implementing plans for PPI (21 of 33). Support to PPI contributors was commonly offered through members of staff at the unit. CONCLUSIONS: PPI is occurring in the majority of trials funded by the HTA programme, but uncertainty remains about how it is assessed and valued. Early involvement, building a relationship between researchers and contributors, responsive or managerial roles, and having defined goals for PPI were associated with impact. Efficiency could be gained by utilising the RCTU network to identify and tackle challenges, and develop a risk-based approach utilising trial characteristics. Recommendations are made to trial funders and the research community. Given the difficulties for some informants in recalling PPI contributions, future research using a prospective approach would be valuable. Ethnographic research that combines observation and multi-informant interviews is likely to be informative in identifying impact. The research community needs to give further consideration to processes for selecting PPI contributors and models of implementing PPI

The utilization of antidepressants and benzodiazepines among people with major depression in Canada

Objective: Although clinical guidelines recommend monotherapy with antidepressants (ADs) for major depression, polypharmacy with benzodiazepines (BDZs) remains an issue. Risks associated with such treatments include tolerance and dependence, among others. We assessed the prevalence and determinants of AD and BDZ utilization among Canadians who experienced a major depressive episode (MDE) in the previous 12 months, and determined the association of seeing a psychiatrist on the utilization of ADs and BDZs. Method: Data were drawn from the 2002 Canadian Community Health Survey: Health and Well-Being, a nationally representative sample of Canadians aged 15 years and older. Descriptive statistics quantified utilization, while logistic regression identified factors associated with utilization, such as sociodemographic characteristics or type of physician seen. Sampling weights and bootstrap variance estimations were used for all analysis. Results: The overall prevalence of AD and BDZ utilization was 49.3% of respondents who experienced an MDE in the past 12 months and reported AD use. Key determinants of utilization were younger age and unemployment in the past week (OR 2.6; P < 0.001). Being seen by a psychiatrist increased utilization (OR 2.5; P < 0.001), possibly because psychiatrists were seeing patients with severe depression. Conclusion: A large proportion of people with past-year MDEs utilized ADs and BDZs. It is unclear how much of this is appropriate given that evidence-based clinical guidelines recommend monotherapy with ADs in the treatment of major depression

Public health research outputs from efficacy to dissemination: a bibliometric analysis

<p>Abstract</p> <p>Background</p> <p>More intervention research is needed, particularly 'real world' intervention replication and dissemination studies, to optimize improvements in health. This study assessed the proportion and type of published public health intervention research papers over time in physical activity and falls prevention, both important contributors to preventable morbidity and mortality.</p> <p>Methods</p> <p>A keyword search was conducted, using Medline and PsycINFO to locate publications in 1988-1989, 1998-1999, and 2008-2009 for the two topic areas. In stage 1, a random sample of 1200 publications per time period for both topics were categorized as: non-public health, non-data-based public health, or data-based public health. In stage 2 data-based public health articles were further classified as measurement, descriptive, etiological or intervention research. Finally, intervention papers were categorized as: efficacy, intervention replication or dissemination studies. Inter-rater reliability of paper classification was 88%.</p> <p>Results</p> <p>Descriptive studies were the most common data-based papers across all time periods (1988-89; 1998-1999;2008-2009) for both issues (physical activity: 47%; 54%; 65% and falls 75%; 64%; 63%), increasing significantly over time for physical activity. The proportion of intervention publications did not increase over time for physical activity comprising 23% across all time periods and fluctuated for falls across the time periods (10%; 21%; 17%). The proportion of intervention articles that were replication studies increased over the three time periods for physical activity (0%; 2%; 11%) and for falls (0%; 22%; 35%). Dissemination studies first appeared in the literature in 2008-2009, making up only 3% of physical activity and 7% of falls intervention studies.</p> <p>Conclusions</p> <p>Intervention research studies remain only a modest proportion of all published studies in physical activity and falls prevention; the majority of the intervention studies, are efficacy studies although there is growing evidence of a move towards replication and dissemination studies, which may have greater potential for improving population health.</p

Users' perspectives of barriers and facilitators to implementing EHR in Canada: A study protocol

<p>Abstract</p> <p>Background</p> <p>In Canada, federal, provincial, and territorial governments are developing an ambitious project to implement an interoperable electronic health record (EHR). Benefits for patients, healthcare professionals, organizations, and the public in general are expected. However, adoption of an interoperable EHR remains an important issue because many previous EHR projects have failed due to the lack of integration into practices and organizations. Furthermore, perceptions of the EHR vary between end-user groups, adding to the complexity of implementing this technology. Our aim is to produce a comprehensive synthesis of actual knowledge on the barriers and facilitators influencing the adoption of an interoperable EHR among its various users and beneficiaries.</p> <p>Methods</p> <p>First, we will conduct a comprehensive review of the scientific literature and other published documentation on the barriers and facilitators to the implementation of the EHR. Standardized literature search and data extraction methods will be used. Studies' quality and relevance to inform decisions on EHR implementation will be assessed. For each group of EHR users identified, barriers and facilitators will be categorized and compiled using narrative synthesis and meta-analytical techniques. The principal factors identified for each group of EHR users will then be validated for its applicability to various Canadian contexts through a two-round Delphi study, involving representatives from each end-user groups. Continuous exchanges with decision makers and periodic knowledge transfer activities are planned to facilitate the dissemination and utilization of research results in policies regarding the implementation of EHR in the Canadian healthcare system.</p> <p>Discussion</p> <p>Given the imminence of an interoperable EHR in Canada, knowledge and evidence are urgently needed to prepare this major shift in our healthcare system and to oversee the factors that could affect its adoption and integration by all its potential users. This synthesis will be the first to systematically summarize the barriers and facilitators to EHR adoption perceived by different groups and to consider the local contexts in order to ensure the applicability of this knowledge to the particular realities of various Canadian jurisdictions. This comprehensive and rigorous strategy could be replicated in other settings.</p

Exploring social and health care representations about home birth: an integrative literature review

Aims: exploring social and health care representations of home birth by conducting an integrative review of the literature. Design: Integrative Literature Review. Data sources: the search was based on the following keywords: 'birth, home,' 'home birth,' 'childbirth, home.' And the terms: 'planned home birth,' and 'empowerment women homebirth' (in English). 'partos en casa,' and 'partos domiciliarios' (in Spanish) in the following databases: Biomedical Central, Cochrane Library, Dialnet, DOAJ, Lilacs, PubMed, Scopus, Scielo, and Web of Science. Review methods: a total of 156 publications dated between 2004 and 2017 were initially obtained and a total of 41 articles were finally selected according to the criteria of inclusion, methodological rigor, and researchers' triangulation. Results: four dimensions of the issue emerged out of the 41 articles analyzed: (a) the Dimension of 'Empowerment in Childbirth;' (b) the Dimension of 'Comparative Socio-Medical Childbirth Studies;' (c) the 'Institutional Dimension of Childbirth;' (d) the 'Cultural Dimension of Childbirth.' Conclusion: from the health management perspective, home birth is not widely accepted today as a valid and safe alternative. However, women's social representations indicate an interest in returning to birth at home as a response to the excessive medicalization and institutionalization of childbirth, and value highly its autonomy and comfort

The global pharmacy workforce: a systematic review of the literature

The importance of health workforce provision has gained significance and is now considered one of the most pressing issues worldwide, across all health professions. Against this background, the objectives of the work presented here were to systematically explore and identify contemporary issues surrounding expansion of the global pharmacy workforce in order to assist the International Pharmaceutical Federation working group on the workforce

The contribution of musculoskeletal disorders in multimorbidity: Implications for practice and policy

People frequently live for many years with multiple chronic conditions (multimorbidity) that impair health outcomes and are expensive to manage. Multimorbidity has been shown to reduce quality of life and increase mortality. People with multimorbidity also rely more heavily on health and care services and have poorer work outcomes. Musculoskeletal disorders (MSDs) are ubiquitous in multimorbidity because of their high prevalence, shared risk factors, and shared pathogenic processes amongst other long-term conditions. Additionally, these conditions significantly contribute to the total impact of multimorbidity, having been shown to reduce quality of life, increase work disability, and increase treatment burden and healthcare costs. For people living with multimorbidity, MSDs could impair the ability to cope and maintain health and independence, leading to precipitous physical and social decline. Recognition, by health professionals, policymakers, non-profit organisations, and research funders, of the impact of musculoskeletal health in multimorbidity is essential when planning support for people living with multimorbidity