The importance of employee voice-speaking up and out about concerns-is widely recognised as fundamental to patient safety and quality of care. However, failures of voice continue to occur, often with disastrous consequences. In this article, we argue that the enduring sociological concepts of the informal organisation and formal organisation offer analytical purchase in understanding the causes of such problems and how they can be addressed. We report a qualitative study involving 165 interviews across three healthcare organisations in two high-income countries. Our analysis emphasises the interdependence of the formal and informal organisation. The formal organisation describes codified and formalised elements of structures, procedures and processes for the exercise of voice, but participants often found it frustrating, ambiguous, and poorly designed. The informal organisation-the informal practices, social connections, and methods for making decisions that are key to coordinating organisational activity-could facilitate voice through its capacity to help people to understand complex processes, make sense of their concerns, and frame them in ways likely to prompt an appropriate organisational response. Sometimes the informal organisation compensated for gaps, ambiguities and inconsistencies in formal policies and systems. At the same time, the informal organisation had a dark side, potentially subduing voice by creating informal hierarchies, prioritising social cohesion, and providing opportunities for retaliation. The formal and the informal organisation are not exclusive or independent: they interact with and mutually reinforce each other. Our findings have implications for efforts to improve culture and processes in relation to voice in healthcare organisations, pointing to the need to address deficits in the formal organisation, and to the potential of building on strengths in the informal organisation that are crucial in supporting voice.

Community-based approaches to healthcare improvement are receiving increasing attention. Such approaches could offer an infrastructure for efficient knowledge-sharing and a potent means of influencing behaviours, but their potential is yet to be optimised. After briefly reviewing challenges to community-based approaches, we describe in detail the clinical community model. Through exploring clinical communities in practice, we seek to identify practical lessons for optimising this community-based approach to healthcare improvement. Through comparative case studies based on secondary analysis, we examine two contrasting examples of clinical communities in practice - the USA-based Michigan Keystone ICU programme, and the UK-based Improving Lung Cancer Outcomes Project. We focus on three main issues. First, both cases were successful in mobilising diverse communities: favourable starting conditions, core teams with personal credibility, reputable institutional backing and embeddedness in wider networks were important. Second, top-down input to organise regular meetings, minimise conflict and empower those at risk of marginalisation helped establish a strong sense of community and reciprocal ties, while intervention components and measures common to the whole community strengthened peer-norming effects. Third, to drive implementation, technical expertise and responsiveness from the core team were important, but so too were 'hard tactics' (e.g. strict limits on local customisation); these were more easily deployed where the intervention was standardised across the community and a strong evidence-base existed. Contrary to the idea of self-organising communities, our cases make clear that vertical and horizontal forces depend on each other synergistically for their effectiveness. We offer practical lessons for establishing an effective balance of horizontal and vertical influences, and for identifying the types of quality problems most amenable to community-based improvement.

Background: Large-scale data collection is an increasingly prominent and influential feature of efforts to improve healthcare delivery, yet securing the involvement of clinical centres and ensuring data comprehensiveness often proves problematic. We explore how improvements in both data submission and completion rates were achieved during a crucial period of the evolution of two large-scale data exercises. Methods: As part of an evaluation of a quality improvement programme, we conducted an ethnographic study involving 90 interviews and 47 days of non-participant observation of two UK national clinical audits in a period before submission of data on adherence to clinical standards became mandatory. Results: Critical to the improvements in submission and completion rates in the two exercises were the efforts of clinical leaders to refigure “data work” as a professionalization strategy. Using a series of strategic manoeuvres, leaders constructed a cultural account that tied the fortunes of the healthcare professions to the submission of high-quality data, proposing that it would demonstrate responsibility, transparency, and alignment with the public interest. In so doing, clinical leadership deployed tactics that might have been seen as unwarranted managerial aggression had they been imposed by parties external to the profession. Many residual challenges were linked not to principled objection by clinicians, but to mundane problems and frustrations in obtaining, recording, and submitting data. The cultural framing of data work as a professional duty was important to resolving its status as an abject form of labour. Conclusions: Improving data quality in large-scale exercises is possible, but requires cooperation with clinical centres. Enabling professional leadership of data work may offer some significant advantages, but attention is also needed to mundane and highly consequential obstacles to participation in data collection.

Background: The need to expand and better engage patients in primary care improvement persists. Purpose: Recognizing a continuum of forms of engagement, this study focused on identifying lessons for optimizing patient partnerships, wherein engagement is characterized by shared decision-making and practice improvement codesign. Methodology: Twenty-three semistructured interviews with providers and patients involved in improvement efforts in seven U.S. primary care practices in the Academic Innovations Collaborative (AIC). The AIC aimed to implement primary care improvement, emphasizing patient engagement in the process. Data were analyzed thematically. Results: Sites varied in their achievement of patient partnerships, encountering material, technical, and sociocultural obstacles. Time was a challenge for all sites, as was engaging a diversity of patients. Technical training on improvement processes and shared learning “on the job” were important. External, organizational, and individual-level resources helped overcome sociocultural challenges: The AIC drove provider buy-in, a team-based improvement approach helped shift relationships from providers and recipients toward teammates, and individual qualities and behaviors that flattened hierarchies and strengthened interpersonal relationships further enhanced “teamness.” A key factor influencing progress toward transformative partnerships was a strong shared learning journey, characterized by frequent interactions, proximity to improvement decision-making, and learning together from the “lived experience” of practice improvement. Teams came to value not only patients’ knowledge but also changes wrought by working collaboratively over time. Conclusion: Establishing practice improvement partnerships remains challenging, but partnering with patients on improvement journeys offers distinctive gains for high-quality patient-centered care. Practice Implications: Engaging diverse patient partners requires significant disruption to organizational norms and routines, and the trend toward team-based primary care offers a fertile context for patient partnerships. Material, technical, and sociocultural resources should be evaluated not only for whether they overcome specific challenges but also for how they enhance the shared learning journey.

Access to safe surgical care represents a critical gap in healthcare delivery and development in many low- and middle-income countries, including Ethiopia. Quality improvement (QI) initiatives at hospital level may contribute to closing this gap. Many such quality improvement initiatives are carried out through international health partnerships. Better understanding of how to optimise quality improvement in low-income settings is needed, including through partnership-based approaches. Drawing on a process evaluation of an intervention to improve surgical services in an Ethiopian hospital, this paper offers lessons to help meet this need. We conducted a qualitative process evaluation of a quality improvement project which aimed to improve access to surgical services in an Ethiopian referral hospital through better management. Data was collected longitudinally and included: 66 in-depth interviews with surgical staff and project team members; observation (135 h) in the surgery department and of project meetings; project-related documentation. Thematic analysis, guided by theoretical constructs, focused on identifying obstacles to implementation. The project largely failed to achieve its goals. Key barriers related to project design, partnership working and the implementation context, and included: confusion over project objectives and project and partner roles and responsibilities; logistical challenges concerning overseas visits; difficulties in communication; gaps between the time and authority team members had and that needed to implement and engage other staff; limited strategies for addressing adaptive—as opposed to technical—challenges; effects of hierarchy and resource scarcity on QI efforts. While many of the obstacles identified are common to diverse settings, our findings highlight ways in which some features of low-income country contexts amplify these common challenges. We identify lessons for optimising the design and planning of quality improvement interventions within such challenging healthcare contexts, with specific reference to international partnership-based approaches. These include: the need for a funded lead-in phase to clarify and agree goals, roles, mutual expectations and communication strategies; explicitly incorporating adaptive, as well as technical, solutions; transparent management of resources and opportunities; leadership which takes account of both formal and informal power structures; and articulating links between project goals and wider organisational interests.

Large-scale (e.g., national) programs could strengthen safety culture, which is foundational to patient safety, yet we know little about how to optimize this potential. In 2013, Brazil’s Ministry of Health launched the National Patient Safety Program, involving hospital-level safety teams and targeted safety protocols. We conducted in-depth qualitative case studies of National Patient Safety Program implementation in two hospitals, with different readiness, to understand how program implementation affected enabling, enacting, and elaborating processes that produce and sustain safety culture. For both hospitals, external mandates were insufficient for enabling hospital-level action. Internal enabling failures (e.g., little safety-relevant senior leadership) hindered enactment (e.g., safety teams unable to institute plans). Limited enactment and weak elaboration processes (e.g., bureaucratic monitoring) failed to institutionalize protocol use and undermined safety culture. Optimizing the safety culture impact of large-scale programs requires effective multi-level enabling and capitalizing on the productive potential of interacting national- and local-level influences.