Abstract:

The development and study of healthcare quality improvement interventions have been reshaped, moving from more intuitive approaches, dominated by biomedical vision and premised on easy transferability, to gradually acknowledge the need for more planning and systematization, with greater incorporation of the social sciences and enhancement of the role of context. Improvement Science has been established, with a conceptual and methodological framework for such studies. Considering the incipient of the debate and scientific production on Improvement Science in Brazil, this article aims to expound its principal conceptual and theoretical fundamentals, focusing on three central themes: the linkage of different disciplines; recognition of the role of context; and the theoretical basis for the design, implementation, and evaluation of interventions.

Keywords:
Health Care; Quality Improvement; Quality of Health Care; Sustainable Development; Innovation

Resumen:

El desarrollo y estudio de intervenciones para la mejora del cuidado de la salud está perfilándose de otras maneras, moviéndose desde los enfoques más intuitivos, con dominio de la visión biomédica y asentados en el presupuesto de su fácil transferibilidad, hacia el reconocimiento gradual de la necesidad de más planificación y sistematización, con una mayor incorporación de las ciencias sociales y valorización del papel del contexto. La Ciencia de la Mejora del Cuidado de Salud se va estableciendo, propiciando un referencial conceptual y metodológico para tales estudios. Considerando la insipiencia del debate y producción sobre Ciencia de la Mejora del Cuidado de Salud en Brasil, este artículo visa discurrir sobre las principales bases conceptuales y teóricas que lo sostienen, enfocándose en tres temas centrales: la coordinación de diferentes disciplinas; el reconocimiento del papel del contexto; y el fundamento teórico para el diseño, implementación y evaluación de las intervenciones.

Palabras-clave:
Atención a la Salud; Mejoramiento de la Salud; Calidad de la Atención de Salud; Desarrollo Sostenible; Innovación

Introduction

Healthcare quality problems result in missed opportunities to produce better outcomes, in avoidable harm to patients and unnecessary cost increases for providers, third-party payers,and society. Meanwhile, actions that seek to introduce changes to deal with such problems in healthcare organizations are commonly based on intuition rather than theories ¹1. Dyson J, Lawton R, Jackson C, Cheater F. Development of a theory-based instrument to identify barriers and levers to best hand hygiene practice among healthcare practitioners. Implement Sci 2013; 8:111., with little accumulation in the generation of scientifically based knowledge. Initiatives in healthcare quality improvement and patient safety frequently produce limited changes, largely unsustainable and difficult to replicate ²2. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015; 24:228-38.^{), (3}3. Grol R, Wensing M, Eccles M, Davis D. Improving patient care: the implementation of change in health care. Second edition. Hoboken: John Wiley & Sons; 2013., especially for different contexts from those for which they were initially conceived.

The concept of quality of care and its dimensions have changed over time, taking on a broad or narrow connotation and with distinct meanings for different authors and actors ⁴4. Donabedian A. The definition of quality and approaches to its assessment. Ann Arbor: Health Administration Press; 1980.^{), (5}5. Campbell SM, Roland MO, Buetow SA. Defining quality of care. Soc Sci Med 2000; 51:1611-25.^{), (6}6. Blumenthal D. Quality of care: what is it? N Engl J Med 1996; 335:891-4.. A seminal author in the area of quality of care, Donabedian ⁴4. Donabedian A. The definition of quality and approaches to its assessment. Ann Arbor: Health Administration Press; 1980. defined quality care as that capable of maximizing the patient's well-being, after taking into account the balance between the expected gains and losses in all stages of the process. The author defined quality as a central attribute of healthcare, based on two essential axes: (i) application of scientific knowledge and technological resources and (ii) quality of the patient-healthcare professional interpersonal relationship. Blumenthal ⁶6. Blumenthal D. Quality of care: what is it? N Engl J Med 1996; 335:891-4., analyzing the variety of definitions and meanings for the concept of quality of care, pointed to the proposal by the U.S. Institute of Medicine (IoM) as one of the most widely used beginning in the 1990s ⁷7. Wehling JH. Defining quality of care. In: Lohr KN, editor. Medicare: a strategy for quality assurance. Volume II: sources and methods. Washington DC: National Academies Press; 1990. p. 116-39.^{), (8}8. National Roundtable on Quality of Health Care. Statement on quality of care. Washington DC: National Academies Press; 1998.. More recently but compatible with the work of Donabedian ⁹9. Donabedian A. An introduction to quality assurance in health care. New York: Oxford University Press; 2003., the definition of IoM indicates that quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge ⁸8. National Roundtable on Quality of Health Care. Statement on quality of care. Washington DC: National Academies Press; 1998.. Six dimensions are intrinsic to this definition: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity ¹⁰10. Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington DC: National Academies Press; 2001..

Healthcare quality improvement, in turn, is translated into changes that directly or indirectly produce better health outcomes ¹¹11. Batalden PB, Davidoff F. What is »," ®,(r) §,§ ­,­ ¹,¹ ²,² ³,³ ß,ß Þ,Þ þ,þ ×,× Ú,Ú ú,ú Û,Û û,û Ù,Ù ù,ù ¨,¨ Ü,Ü ü,ü Ý,Ý ý,ý ¥,¥ ÿ,ÿ ¶,¶ quality improvement »," ®,(r) §,§ ­,­ ¹,¹ ²,² ³,³ ß,ß Þ,Þ þ,þ ×,× Ú,Ú ú,ú Û,Û û,û Ù,Ù ù,ù ¨,¨ Ü,Ü ü,ü Ý,Ý ý,ý ¥,¥ ÿ,ÿ ¶,¶ and how can it transform healthcare? Qual Saf Health Care 2007; 16:2-3., incorporating technical elements that are amenable to a certain degree of standardization, but mainly personal interactions interwoven with the context ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (13}13. Margolis P, Provost LP, Schoettker PJ, Britto MT. Quality improvement, clinical research, and quality improvement research: opportunities for integration. Pediatr Clin North Am 2009; 56:831-41.^{), (14}14. Chopra V, Shojania KG. Recipes for checklists and bundles: one part active ingredient, two parts measurement. BMJ Qual Saf 2013; 22:93-6..

The idea of a Science of Improvement, first proposed by Langley et al. ¹⁵15. Langley GJ, Moen R, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide: a practical approach to enhancing organizational performance. San Francisco: Jossey-Bass Publishers; 2009. in 1996 in the first edition of The Improvement Guide, assumes that improvements in any area of activity derive from the development, testing, and implementation of changes, and that basing improvement processes on science reasoning assure more effective results. The application of the Science of Improvement to each specific area should be informed by the experience, knowledge, and intuition of experts that are closest to each of their problems.

Improvement Science, applied to healthcare, has gained identity and visibility in the last eight years ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (16}16. Perla RJ, Provost LP, Parry GJ. Seven propositions of the Science of Improvement: exploring foundations. Qual Manag Health Care 2013; 22:179-86.^{), (17}17. Marshall M, Pronovost P, Dixon-Woods M. Promotion of improvement as a science. Lancet 2013; 381:419-21., and has been described as an evolving area, focused on the development and evaluation of interventions for healthcare improvement, on the explanation of how such interventions work and produce the expected results and under which contextual conditions, and the identification of strategies for their dissemination ¹⁸18. The Health Foundation. Evidence scan: Improvement Science. London: The Health Foundation; 2011.. Studies have multiplied in the area, featuring the development of an explanatory theory for a successful project in reducing central venous catheter infections in intensive care units (ICUs) in Michigan, USA ¹⁹19. Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, Pronovost PJ. Explaining Michigan: developing an ex post theory of a quality improvement program. Milbank Q 2011; 89:167-205., and a study on the attempt to replicate the Michigan results in England ²⁰20. Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining Matching Michigan: an ethnographic study of a patient safety program. Implement Sci 2013; 8:70.. Another example focused on the project for improvement of discharge summaries from ICUs in England ²¹21. Goulding L, Parke H, Maharaj R, Loveridge R, McLoone A, Hadfield S, et al. Improving critical care discharge summaries: a collaborative quality improvement project using PDSA. BMJ Qual Improv Rep 2015; 4:u203938.w3268.. A consistent international effort has been made to establish guidelines for publications in the area ²²22. Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S; SQUIRE Development Group. Publication guidelines for quality improvement in health care: evolution of the SQUIRE project. Qual Saf Health Care 2008; 17 Suppl 1:i3-9.^{), (23}23. Ogrinc G, Mooney SE, Estrada C, Foster T, Goldmann D, Hall LW, et al. The SQUIRE (Standards for Quality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration. Qual Saf Health Care 2008; 17 Suppl 1:i13-32.^{), (24}24. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. Squire 2.0 (Standards for Quality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. Am J Crit Care 2015; 24:466-73..

Improvement Science identifies three key elements: the intervention's technical component, the implementation strategy, and the context in which the intervention is implemented ²⁰20. Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining Matching Michigan: an ethnographic study of a patient safety program. Implement Sci 2013; 8:70.. Still, a known tension exists between the urgency of acting on quality of care problems and the insufficiency of scientific evidence for basing such measures ¹⁷17. Marshall M, Pronovost P, Dixon-Woods M. Promotion of improvement as a science. Lancet 2013; 381:419-21.. Improvement Science is structured on the theoretical-methodological-conceptual knowledge consolidated in other fields to deal with specificities of the health area, particularly those of healthcare. Improvement Science also interacts with related health disciplines such as "health services research", "quality assurance", or "quality of care evaluation" ⁹9. Donabedian A. An introduction to quality assurance in health care. New York: Oxford University Press; 2003.^{), (25}25. White KL. Health service research and epidemiology. In: Holland W, Olsen J, Florey CV, editors. The development of modern epidemiology: personal aspects from those who were there. New York: Oxford University Press; 2007. p. 183-96.^{), (26}26. Donabedian A. The criteria and standards of quality. Ann Arbor: Health Administration Press; 1982.. Its identity relies on the focus on healthcare improvement interventions, systematic studies of the mechanisms of change in such interventions, and the conditions for their functioning.

Healthcare quality improvement interventions are predominantly complex, with multiple components that can act independently or interdependently, leading to interactions capable of dynamically modifying the intervention itself ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50.^{), (28}28. Øvretveit J, Leviton L, Parry G. Increasing the generalizability of improvement research with an improvement replication programme. BMJ Qual Saf 2011; 20 Suppl 1:i87-91.^{), (29}29. Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337:a1655.^{), (30}30 .Wears RL. Improvement and evaluation. BMJ Qual Saf 2015; 24:92-4.. Such components can act on the health system, the organizations, the behavior of health professionals, the way patients are cared for in health services, or even patients' behavior ¹³13. Margolis P, Provost LP, Schoettker PJ, Britto MT. Quality improvement, clinical research, and quality improvement research: opportunities for integration. Pediatr Clin North Am 2009; 56:831-41.^{), (31}31. Øvretveit J. Understanding the conditions for improvement: research to discover which influences affect improvement success. BMJ Qual Saf 2011; 20 Suppl 1:i18-23..

Improvement Science aims to reconcile knowledge originated in practice with scientific systemization ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (32}32. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf 2015; 24:325-36.. It values the design and evaluation of local interventions and their potential for large-scale application. It postulates that well-systematized learning in health organizations has much to contribute to generalizable knowledge. Meanwhile, it emphasizes the importance of knowing the active components, that is, those capable of producing changes and that characterize the intervention (e.g., training to increase the healthcare team's ability to deal with a given situation) and mechanisms by which it acts to effectively promote the intended changes (e.g., education, persuasion, incentives, etc.) ³³33. Colquhoun H, Leeman J, Michie S, Lokker C, Bragge P, Hempel H, et al. Towards a common terminology: a simplified framework of interventions to promote and integrate evidence into health practices, systems, and policies. Implement Sci 2014; 9:51.. It overlaps with disciplines, such as Implementation Science ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50.^{), (34}34. Sobo EJ, Bowman C, Gifford AL. Behind the scenes in health care improvement: the complex structures and emergent strategies of Implementation Science. Soc Sci Med 2008; 67:1530-40.^{), (35}35. May C. Towards a general theory of implementation. Implement Sci 2013; 8:18.^{), (36}36. Eccles MP, Armstrong D, Baker R, Cleary K, Davies H, Davies S, et al. An implementation research agenda. Implement Sci 2009; 4:18. and Translational Research ³⁵35. May C. Towards a general theory of implementation. Implement Sci 2013; 8:18.^{), (37}37. Thornicroft G, Lempp H, Tansella M. The place of implementation science in the translational medicine continuum. Psychol Med 2011; 41:2015-21.^{), (38}38. Ting HH, Shojania KG, Montori VM, Bradley EH. Quality improvement: science and action. Circulation 2009;119:1962-74..

Considering the incipience of the debate and scientific production on Improvement Science in Brazil, this article aims to address its principal characteristics, based on a review of the international literature, with a focus on three central themes: (1) articulation of different disciplines; (2) recognition of the role of context; and (3) the theoretical basis for designing, implementing, and evaluating interventions.

Articulation of knowledge and approaches from different disciplines

Improvement Science has flourished in an environment of recognition of the importance and complementariness of professional and organizational approaches to the identification and management of healthcare quality problems. This environment features, side-by-side, the valorization of processes of care that prioritize clinical effectiveness oriented by scientific evidence and organizational contexts based on responsibility and accountability concerning the results obtained ³⁹39. Donaldson LJ, Gray JAM. Clinical governance: a quality duty for health organisations. Qual Health Care 1998; 7 Suppl:S37-44.^{), (40}40. Buetow SA, Roland M. Clinical governance: bridging the gap between managerial and clinical approaches to quality of care. Qual Health Care 1999; 8:184-90..

Disciplines like quality management, epidemiology, program evaluation, psychology, and social sciences are articulated to identify interventions capable of producing positive changes in healthcare quality, measurement of such changes, explanation of the mechanisms involved, and characterization of the contextual conditions for their functioning and sustainability. However, the complementariness of views is not always congruent, which generates tensions and fragmented perspectives ¹⁷17. Marshall M, Pronovost P, Dixon-Woods M. Promotion of improvement as a science. Lancet 2013; 381:419-21.^{), (32}32. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf 2015; 24:325-36.^{), (41}41. Parry G, Mate K, Perla R, Provost L. Promotion of improvement as a science. Lancet 2013; 381:1902-3.. The search for some harmonization between distinct visions is a work in progress, involving the combination of diverse theoretical ⁴²42. Grol R, Wensing M, Bosch M, Hulscher M, Eccles M. Theories on implementation of change in healthcare. In: Grol R, Wensing M, Eccles M, Davis D, editors. Improving patient care: the implementation of change in health care. Hoboken: John Wiley & Sons; 2013. p. 18-39.^{), (43}43. Van Lange PAM, Kruglanski AW, Higgins ET, editors. Handbook of theories of social psychology. Los Angeles: Sage Publications; 2012.^{), (44}44. Mintzberg H. Criando organizações eficazes: estruturas em cinco configurações. São Paulo: Editora Atlas; 1995. (Table 1) and methodological approaches ³²32. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf 2015; 24:325-36..

The scope of Healthcare Improvement Science includes quality improvement projects, predominantly developed at the local level, which value the conception and implementation of incremental changes and the learning acquired through such experience ³²32. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf 2015; 24:325-36.^{), (45}45. Rubenstein LV, Hempel S, Farmer MM, Asch SM, Yano EM. Finding order in heterogeneity: types of quality-improvement intervention publications. Qual Saf Health Care 2008; 17:403-8.. These projects, characterized by their pragmatic perspective, derive from quality management andmost probably are at the root of the name "Science of Improvement" in a broader context, in combination with the dynamic process of testing and adjusting changes.

The theoretical-conceptual framework for the System of Profound Knowledge elaborated by Edward Deming is one of the fundamentals of quality improvement ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (15}15. Langley GJ, Moen R, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide: a practical approach to enhancing organizational performance. San Francisco: Jossey-Bass Publishers; 2009.^{), (16}16. Perla RJ, Provost LP, Parry GJ. Seven propositions of the Science of Improvement: exploring foundations. Qual Manag Health Care 2013; 22:179-86.^{), (46}46. Deming WE. The new economics for industry, government, education. Boston: MIT Press; 1994.. It includes four interrelated pillars ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (16}16. Perla RJ, Provost LP, Parry GJ. Seven propositions of the Science of Improvement: exploring foundations. Qual Manag Health Care 2013; 22:179-86.^{), (17}17. Marshall M, Pronovost P, Dixon-Woods M. Promotion of improvement as a science. Lancet 2013; 381:419-21.^{), (47}47. Perla RJ, Parry GJ. The epistemology of quality improvement: it's all Greek. BMJ Qual Saf 2011; 20 Suppl 1:i24-7.: (1) a system vision, defining system as a network of interdependent components that interact to achieve a specific objective; (2) alignment between proposed actions and the relevant available knowledge, knowing that people's perception of the knowledge impacts their learning and decision-making; (3) understanding of variations in the processes and results, distinguishing between variations that are inherent to the process and those that are not typically part of it; and (4) grasping means to engage people in processes of change, considering that social and interpersonal structures impact the process or system's performance. In methodological terms, such projects highlight, among others, application of Plan-Do-Study-Act (PDSA) cycles in testing and adjusting interventions ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (15}15. Langley GJ, Moen R, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide: a practical approach to enhancing organizational performance. San Francisco: Jossey-Bass Publishers; 2009.^{), (16}16. Perla RJ, Provost LP, Parry GJ. Seven propositions of the Science of Improvement: exploring foundations. Qual Manag Health Care 2013; 22:179-86. and statistical control techniques in monitoring relevant process and result indicators for evaluating the implementation and effects of interventions ⁴⁸48. Montgomery DC. Statistical quality control. 7th edition. Hoboken: John Wiley & Sons; 2013.^{), (49}49. Thor J, Lundberg J, Ask J, Olsson J, Carli C, Harenstam KP, et al. Application of statistical process control in healthcare improvement: systematic review. Qual Saf Health Care 2007; 16:387-99.^{), (50}50. Provost LP, Murray SK. The health care data guide: learning from data for improvement. San Francisco: Jossey-Bass Publishers; 2011.. Consecutive PDSA cycles should display dependency, simulating the scientific method; hypotheses should be described, tested, and analyzed, and the results should foster learning and a knowledge base for new cycles ¹⁶16. Perla RJ, Provost LP, Parry GJ. Seven propositions of the Science of Improvement: exploring foundations. Qual Manag Health Care 2013; 22:179-86..

The literature suggests that the interventionʼs design should begin with careful analysis of the desirable changes, contextual conditions, and theories (organizational, behavioral, social, innovation-related, etc.) that underpin hypotheses on the pertinent mechanisms of change. A theory of change should be formulated a priori¹⁹19. Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, Pronovost PJ. Explaining Michigan: developing an ex post theory of a quality improvement program. Milbank Q 2011; 89:167-205., and a theory of change proposed a posteriori, at the end of the tests. The capacity to generate knowledge and its potential generalization derives from the accumulation of local experiences and consistent compilation of the resulting theories of change, the center of which is the well-based explanation of the respective mechanisms of change.

However, the scope of Improvement Science, applied to healthcare, when compared to that of Science of Improvement, is expanded by the inclusion of studies to evaluate interventions for improvement of care, focused on questions concerning their process of implementation and effectiveness, efficiency, and sustainability. In this sense, disciplines such as health services research, epidemiology, and health technology assessment contribute to the tradition of studies on healthcare quality, including quantitative scientific approaches with experimental, quasi-experimental, and observational designs ⁵¹51. Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care 2003; 12:47-52.^{), (52}52. Grimshaw J, Campbell M, Eccles M, Steen N. Experimental and quasi-experimental designs for evaluating guideline implementation strategies. Fam Pract 2000; 17 Suppl 1:S11-8.^{), (53}53. Shojania KG, Grimshaw JM. Evidence-based quality improvement: the state of the science. Health Aff (Millwood) 2005; 24:138-50., as well as evaluation models like those proposed by Donabedian ²⁶26. Donabedian A. The criteria and standards of quality. Ann Arbor: Health Administration Press; 1982.. A recent review mapped different types of studies, highlighting their principles, advantages, and disadvantages and the opportunities for methodological improvement with a view towards the evaluation of interventions for healthcare quality improvement ³²32. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf 2015; 24:325-36..

In program evaluation ²2. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015; 24:228-38.^{), (32}32. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf 2015; 24:325-36., Improvement Science has searched for elements for a theoretically oriented approach, aimed as grasping the mechanisms of change involved and how and why they work in healthcare quality improvement interventions. Program evaluation values the dynamic nature of a program's implementation, recommending the registration of its development over time, appreciation of the degree to which the implementation departs from the initial plan, and identification of inherent characteristics of the program and of the setting in which it is implemented associated with its success (or failure). In short, it proposes the formulation of a "small explanatory theory" for each program ²2. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015; 24:228-38.^{), (54}54. Lipsey MW. Theory as method: small theories of treatments. In: Sechrest L, Scott A, editors. Understanding causes and generalizing about them. San Francisco: Jossey-Bass Publishers; 1993. p. 5-38..

Additionally, Improvement Science explicitly acknowledges the importance of understanding behavioral and social phenomena pertaining to the promotion of changes for a healthcare quality improvement intervention (Table 1). Psychology ⁵⁵55. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, et al. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005; 14:26-33.^{), (56}56. Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci 2012; 7:37.^{), (57}57. Gardner B, Whittington C, McAteer J, Eccles MP, Michie S. Using theory to synthesise evidence from behaviour change interventions: the example of audit and feedback. Soc Sci Med 2010; 70:1618-25.^{), (58}58. Eccles MP, Grimshaw JM, MacLennan G, Bonetti D, Glidewell L, Pitts NB, et al. Explaining clinical behaviors using multiple theoretical models. Implement Sci 2012; 7:99.^{), (59}59. French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, Michie S, et al. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci 2012; 7:38. has especially backed the implementation of interventions, based on the understanding that quality improvement depends fundamentally on people's behavior. Meanwhile, the social sciences expand the understanding of quality improvement as a social and political process, considering power relations and social interactions ²²22. Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S; SQUIRE Development Group. Publication guidelines for quality improvement in health care: evolution of the SQUIRE project. Qual Saf Health Care 2008; 17 Suppl 1:i3-9. intrinsic to the intervention itself and to the context of its implementation.

The incorporation and sustainability of an intervention for improvement depends on the degree to which its underlying knowledge is scientifically validated, and how and to what extent individuals/professionals absorb this knowledge and thus start to apply it in daily practice. The heart of quality improvement processes lies at the intersection between the belief (expressed in the action) and the scientific evidence that sustains an intervention ¹⁶16. Perla RJ, Provost LP, Parry GJ. Seven propositions of the Science of Improvement: exploring foundations. Qual Manag Health Care 2013; 22:179-86.. In the health field, at least partially, the evidence originates in clinical research. The human sciences contribute to the understanding of how professionals absorb and apply this new knowledge, valuing the dynamic nature of the processes of change, as well as the inherent conflicts.

Valorization of the role of context

The search for understanding the mechanisms of change and identifying obstacles and levers of the implementation and dissemination of interventions incur in the valorization of the context by Improvement Science ⁶⁰60. Øvretveit J. How does context affect quality improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 59-85.^{), (61}61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29.^{), (62}62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.^{), (63}63. Dixon-Woods M. The problem of context in quality improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 87-101., defined by some authors as all factors that are not part of the improvement intervention itself ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50.^{), (60}60. Øvretveit J. How does context affect quality improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 59-85..

An interest in the role of the setting or context in organizations' performance first emerged in the organizational field with the system and contingency theories beginning in the 1950s, when organizations came to be seen as open systems which, in order to achieve their objectives expressed in their products and services, need resources or elements found in their inner and outer setting. Organizational performance depends on adequate interaction established between such elements, hence their importance. The concern lies less in defining setting or context and more in identifying and understanding the characteristics of these internal and external elements ⁴⁴44. Mintzberg H. Criando organizações eficazes: estruturas em cinco configurações. São Paulo: Editora Atlas; 1995.^{), (64}64. Daft RL. Organizações: teoria e projetos. São Paulo: Cengage Learning; 2008.^{), (65}65. Morgan G. Imagens da organização. São Paulo: Editora Atlas; 1996..

Although the distinction between internal and external is not a consensus in the literature, some healthcare quality improvement authors highlight its usefulness for understanding the internal and external effects and constraints and especially for identifying which ones are modifiable or negotiable ³¹31. Øvretveit J. Understanding the conditions for improvement: research to discover which influences affect improvement success. BMJ Qual Saf 2011; 20 Suppl 1:i18-23.^{), (61}61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29.^{), (62}62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.^{), (66}66. Kaplan HC, Brady PW, Dritz MC, Hooper DK, Linam WM, Froehle CM, et al. The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q 2010; 88:500-59..

External elements are defined as socio-political-economic, cultural, regulatory, professional, and technological aspects or conditions, including healthcare system characteristics and financing, among others. Meanwhile, internal elements include structural characteristics, the nature of the work processes, network and communication, and organizational culture and climate. Also considered are the characteristics of individuals involved, i.e., their interests, knowledge, belonging, motivation, and values ⁶¹61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29.^{), (66}66. Kaplan HC, Brady PW, Dritz MC, Hooper DK, Linam WM, Froehle CM, et al. The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q 2010; 88:500-59..

Quality improvement thus results from organizational interventions that are contingent on the context in which they occur or, more specifically, contingent on the characteristics and interactions established among their internal elements and between the latter and external elements. Although the distinction between intervention and context of intervention is somewhat arbitrary, the identification of internal and external factors or elements can shed light on the necessary conditions for being successful in the intervention implementation ³¹31. Øvretveit J. Understanding the conditions for improvement: research to discover which influences affect improvement success. BMJ Qual Saf 2011; 20 Suppl 1:i18-23..

In short, healthcare quality improvement interventions do not happen in a sterile or laboratory setting ⁶³63. Dixon-Woods M. The problem of context in quality improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 87-101.. Factors facilitate or hinder implementation of the intervention, influencing its effectiveness and financial and temporal sustainability. In general, the limit between intervention and context is tenuous. Interactions among contextual factors themselves and between contextual factors and the implementation process are dynamic, modifying the process over time and frequently requiring adjustments to the intervention's components ²⁸28. Øvretveit J, Leviton L, Parry G. Increasing the generalizability of improvement research with an improvement replication programme. BMJ Qual Saf 2011; 20 Suppl 1:i87-91..

In order to understand the context in greater detail, some authors distinguish between the structural and psychological perspectives, related to the objective context (structure or resources) and subjective context (actors' behavior, organizational climate, and assimilative capacity), or "hard" and "soft" contextual factors ⁶¹61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29.^{), (62}62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.^{), (66}66. Kaplan HC, Brady PW, Dritz MC, Hooper DK, Linam WM, Froehle CM, et al. The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q 2010; 88:500-59.. Robert & Fulop ⁶²62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57. and Bate ⁶¹61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29. advocate for the need to combine the notion of contexts that are receptive or non-receptive to change, with new contributions from psychology, based on behaviors involved in readiness to change and emotional receptiveness at the individual and organizational levels (Table 1).

Little is known about which contextual elements are most important for success, whether they change in different improvement initiatives, or even whether their importance changes over time ³¹31. Øvretveit J. Understanding the conditions for improvement: research to discover which influences affect improvement success. BMJ Qual Saf 2011; 20 Suppl 1:i18-23.. Recognition of their importance raises two concerns, the implementation strategy and the organizational change ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50.^{), (62}62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.^{), (66}66. Kaplan HC, Brady PW, Dritz MC, Hooper DK, Linam WM, Froehle CM, et al. The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q 2010; 88:500-59., since an intervention's implementation assumes some organizational change, with adaptation and rearrangements in the intervention itself for its assimilation in different contexts.

By valuing the role of context, healthcare improvement interventions are viewed less from the angle of normative or prescriptive decisions and more as a complex and multifaceted strategy for organizational change, contingent on the context ⁶²62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.. An additional challenge is to deal with the socio-technical nature and complexity of tasks and work processes in health organizations. The factors require a specific multidimensional approach to the type and scope of the change/intervention itself ⁶²62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57..

Theoretical basis for the design, implementation, and evaluation of interventions

Theories link interrelated concepts and proposals capable of explaining or predicting events based on the specification of relations between variables, inherent to which is the perspective of generalization or broad application and testability ⁵⁵55. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, et al. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005; 14:26-33.^{), (67}67. Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health 2010; 31:399-418.. But it is also useful the understanding,as "theoretical", of that which simply provides an assertive of a significant interaction between variables, or a coherent conceptual framework, in the shape of a map or model, of a phenomenon or complex interaction, describing how an independent variable changes the behavior of a dependent variable ²2. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015; 24:228-38..

Davidoff et al. ²2. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015; 24:228-38. refer to the need to demystify the use of theories in the area of healthcare quality improvement, underlining that they, whether formal or informal, provide the rationale for any human endeavor, so that the relevant question in quality improvement processes is whether the theory or theories used are explicitly stated. The authors differentiate heuristically between grand theories, mid-range theories, and program theories (small theories). In the first, they highlight the high level of abstraction and the capacity for generalization to different domains; in mid-range theories, the application to delimited areas and the intermediary position between minor working hypotheses and the all-inclusive speculations comprising a master conceptual scheme; and in small theories, the pragmatism and the specificity associated with each program or intervention ²2. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf 2015; 24:228-38.^{), (54}54. Lipsey MW. Theory as method: small theories of treatments. In: Sechrest L, Scott A, editors. Understanding causes and generalizing about them. San Francisco: Jossey-Bass Publishers; 1993. p. 5-38.. The theory of the diffusion of innovations and normalization process theory are cited as examples of mid-range theories that provide frameworks for understanding the problem or guidelines for the development of interventions. Meanwhile, in the development, implementation, and evaluation of healthcare quality improvement interventions, the small theories related to specific interventions describe the intervention's composition, expected results, mechanisms of change, and methods to assess the results.

In designing interventions, theories are thus expected to furnish the basis for defining the mechanisms of change to be considered, and, indirectly, for proposing components to be incorporated. Testing these interventions in a given context would thus function as a test of hypotheses concerning the predicted mechanisms of change under the observed conditions. As mentioned above, theories of change are defined a priori and updated a posteriori, with the capacity for generalization deriving from accumulation of experiences in different contexts ¹⁹19. Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, Pronovost PJ. Explaining Michigan: developing an ex post theory of a quality improvement program. Milbank Q 2011; 89:167-205.. Ideally, theories should also back the implementation and evaluation of interventions, providing elements for grasping plausible mechanisms of change and for explaining their success or failure.

The literature presents a set of studies identifying theories ³⁵35. May C. Towards a general theory of implementation. Implement Sci 2013; 8:18.^{), (58}58. Eccles MP, Grimshaw JM, MacLennan G, Bonetti D, Glidewell L, Pitts NB, et al. Explaining clinical behaviors using multiple theoretical models. Implement Sci 2012; 7:99.^{), (66}66. Kaplan HC, Brady PW, Dritz MC, Hooper DK, Linam WM, Froehle CM, et al. The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q 2010; 88:500-59.^{), (67}67. Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health 2010; 31:399-418.^{), (68}68. Novotná G, Dobbins M, Henderson J. Institutionalization of evidence-informed practices in healthcare settings. Implement Sci 2012; 7:112.^{), (69}69. Dearing JW. Applying diffusion of innovation theory to intervention development. Res Soc Work Pract 2009; 19:503-18. for the prediction and explanation of mechanisms of change associated with healthcare quality improvement interventions at the macro political, organizational and social context and individual behavior levels (Table 1).

Implementation Theory defines implementation as a social process of collective action whose central concepts derive from sociological theories of social fields and systems and cognitive theories of psychology. Based on these theories, a more comprehensive explanation of these elements constituing implementation process could be built ³⁵35. May C. Towards a general theory of implementation. Implement Sci 2013; 8:18.. The implementation process is explained as the interaction between "emerging expressions of agency" (or what people do in order to make something happen, and how they deal with different components of a complex intervention) and the context's dynamic elements (the socio-structural and socio-cognitive resources people draw on to perform their actions of agency). Agency expresses people's capacity and ability to achieve certain objectives based on their own actions in a complex context with constraints (Table 1).

The implementation is begun deliberately by the agents that intend to introduce a new practice or modify institutionalized practices, developed by themselves or by other agents, which modifies the social system. The implementation will imply changes that can impact individual, organizational, and societal behavior. Agents, individuals or groups engaged in the mobilization of material and cultural resources, seek to ensure the consent, cooperation, and knowledge of other agents that coexist in the context in which implementation of the practice takes place ³⁵35. May C. Towards a general theory of implementation. Implement Sci 2013; 8:18..

Intrinsic to this concept of implementation are two central concepts: social system and mechanisms. Social system is defined as the set of contingent, dynamic, and socially organized relations that shape the structure in which agents (individuals or groups) act, interacting among themselves, for the expression of agency. Systems are emerging, continuously shaped in time and space by endogenous and exogenous factors, with a relatively unpredictable future. And within these emerging structural conditions, mechanisms operate, defined as the processes that promote or hinder a change in an actual system, unfolding over time and expressing contributions by the agency (human intervention). The focus on the mechanisms helps understand the means for promotion of changes projected in the interventions, the circumstances in which they act, and how they attempt to shape them ³⁵35. May C. Towards a general theory of implementation. Implement Sci 2013; 8:18.. In short, based on the above-mentioned theory, the effective implementation of a healthcare quality improvement intervention is conditioned by human behavior and the functioning of groups and organizations and their contexts, and can be explained from different points of view.

Considering the lack of convincing evidence that some theories are more explanatory than others, Grol et al. ⁴²42. Grol R, Wensing M, Bosch M, Hulscher M, Eccles M. Theories on implementation of change in healthcare. In: Grol R, Wensing M, Eccles M, Davis D, editors. Improving patient care: the implementation of change in health care. Hoboken: John Wiley & Sons; 2013. p. 18-39. propose and describe groups of applicable theories for the area of healthcare quality improvement, from different perspectives (Table 1): (1) individual professionals; (2) social context and interaction; (3) organizational context; and (4) economic context. The first block includes cognitive, educational, and motivational theories that seek to explain how professionals make their choices and decisions. The second block includes theories that focus on the influence of the social context in the process of change (social norms and values within a social network, leadership, peers, and the role of models), that interact with actions by individuals in the implementation processes. They are the theories of communication, social learning, influence, social network, teamwork, professional development, and leadership. The third block focuses on the organizational context involving the theories of innovative organizations, quality management, reengineering, complexity, organizational learning, and organizational culture. Theories on the influence of economic factors focus on market regulations, competition, payment systems, and financial incentives, factors to be identified in the implementation of changes although they are largely beyond the control of the agents that promote them.

Improvement Science also adds theoretical frameworks for the implementation of healthcare quality improvement interventions, although it acknowledges their inherent limitations, due both to simplification and non-exhaustiveness, which impacts their applicability ⁶¹61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29.^{), (62}62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.^{), (70}70. Kaplan HC, Provost LP, Froehle CM, Margolis PA. The model for understanding success in quality (MUSIQ): building a theory of context in healthcare quality improvement. BMJ Qual Saf 2012; 21:13-20.. Such theoretical frameworks feature Promoting Action on Research Implementation in Health Services (PARIHS), the Consolidated Framework for Implementation Research (CFIR), the Theoretical Domains Framework (TDF), and the Model for Understanding Success in Quality (MUSIQ) (Table 2).

PARIHS, proposed on the basis of initiatives for the implementation of clinical guidelines, adopts evidence, context, and facilitation as pillars, where context consists of receptiveness to the intervention/change, organizational culture, leadership support, and capacity for evaluation ⁷¹71. Kitson A, Harvey G, McCormack B. Enabling the implementation of evidence based practice: a conceptual framework. Qual Health Care 1998; 7:149-58.^{), (72}72. Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci 2008; 3:1.^{), (73}73. Helfrich CD, Damschroder LJ, Hagedom HJ, Daggett GS, Sahay A, Ritchie M, et al. A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework. Implement Sci 2010; 5:82..

CFIR ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50.^{), (61}61. Bate P. Context is everything. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 1-29.^{), (62}62. Robert G, Fulop N. The role of context in successful improvement. In: Bate P, Robert G, Fulop N, Øvretveit J, Dixon-Woods M, editors. Perspectives on context: a selection of essays considering the role of context in successful quality improvement. London: The Health Foundation; 2014. p. 31-57.^{), (74}74. McDonald KM. Considering context in quality improvement interventions and implementation: concepts, frameworks, and application. Acad Pediatr 2013; 13(6 Suppl):S45-53. is based on approaches and empirical evidence examined by 19 preceding theoretical models, including PARIHS ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50.. Implementation is seen as a social process, where context is the set of unique circumstances or factors surrounding an effort at a given implementation. This conceptual framework contains five domains: intervention, outer setting, inner setting, characteristics of the individuals involved, and the implementation process - with correlated constructs described. The central point of CFIR is the intervention's local adaptation, minimizing individuals' resistance (analyzed in light of agency and planned behavior theory) ²⁷27. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4:50..

TDF ⁵⁵55. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, et al. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005; 14:26-33.^{), (56}56. Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci 2012; 7:37. concentrates on the explanation of prevailing behaviors or readiness for change. In the current version, it is structured in 14 domains (Table 2), describing mediators of behavior change in healthcare ⁷⁵75. Francis JJ, O'Connor D, Curran J. Theories of behaviour change synthesised into a set of theoretical groupings: introducing a thematic series on the theoretical domains framework. Implement Sci 2012; 7:35..

MUSIQ ⁶⁶66. Kaplan HC, Brady PW, Dritz MC, Hooper DK, Linam WM, Froehle CM, et al. The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q 2010; 88:500-59.^{), (70}70. Kaplan HC, Provost LP, Froehle CM, Margolis PA. The model for understanding success in quality (MUSIQ): building a theory of context in healthcare quality improvement. BMJ Qual Saf 2012; 21:13-20. addresses contextual variables classified according to the level of the system in which they operate: microsystems, consisting of small groups that work directly in healthcare provision; macrosystems, which include various microsystems or organizations; and the outer setting, involving characteristics of the society in which the macrosystems act. It is assumed that factors pertaining to microsystems and healthcare quality improvement teams have a direct influence, while organizational factors and the outer setting indirectly influence the intervention's success.

Lukas et al. ⁷⁶76. Lukas CV, Holmes SK, Cohen AB, Restuccia J, Cramer IE, Shwartz M, et al. Transformational change in health care systems: an organizational model. Health Care Manage Rev 2007; 32:309-20. identify five critical factors in the inner setting: impetus for change; leadership committed to quality; professionals' engagement in problem-solving; organizational alignment of objectives, resource allocation, and actions at all levels of the organization; and integration of the organization's individual components, overcoming traditional intraorganizational barriers.

Specifically on patient safety, Taylor et al. ⁷⁷77. Taylor SL, Dy S, Foy R, Hempel S, McDonald KM, Øvretveit J, et al. What context features might be important determinants of patient safety practice interventions? BMJ Qual Saf 2011; 20:611-7. proposed four contextual domains: culture of safety and involvement of the team and leadership in the unit; structural characteristics of the organization; external factors; and availability of management and implementation tools (personnel training, internal auditing, existence of persons in charge, and degree of customization of the intervention).

Conclusions

New challenges for the quality of care field are raised by the recognition that clinical and organizational approaches are complementary in healthcare quality improvement and that the availability of scientific evidence in favor of given processes is not sufficient to promote changes in healthcare. The magnitude of efforts and initiatives over the years and the mismatch in the effects obtained raise new questions for the healthcare quality improvement agenda. In this sense, approaches with a predominantly biomedical vision and premised on easy transferability have gradually given way to proposals that aim to deal with the complexity of the phenomena at stake, formulated with more planning and systemization, incorporation of new knowledge from the social sciences, and appreciation of contextual aspects and the implementation process itself.

From this perspective, Improvement Science is building a conceptual and methodological framework for interventions focused on healthcare quality improvement. The current review has prioritized three axes which in a sense provide the basis for Improvement Science. Still, they are intrinsically interwoven, delimited by fuzzy borders and, generally, complementary. The first axis, based on the articulation of different disciplines and approaches, seeks a more comprehensive understanding of the processes involved in healthcare quality improvement. The second, which can be seen as the result of advances in the first, is the explicit recognition of the critical role of context in the success or failure of initiatives for healthcare quality improvement. Finally, the third calls attention to the importance of a theoretical foundation for the design, implementation, and evaluation of interventions.

The available literature on Improvement Science provides contributions that we have reviewed systematically here. Although some of these contributions may sound commonsensical and in fact refer to aspects that are widely recommended in various areas of knowledge, we have valued them here as posing concrete challenges for the practice of healthcare quality improvement. What still predominates, especially in Brazil's reality, are healthcare quality improvement initiatives developed intuitively by "trial and error", without a more systematic anticipation of how and why the desired change will be promoted and without systematic follow-up of its implementation and results.

Improvement Science wagers on the possibility of agile learning based on local healthcare quality improvement interventions, without waiving scientific rigor to guarantee the findings' validity in a given context and its generalization to other settings ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (13}13. Margolis P, Provost LP, Schoettker PJ, Britto MT. Quality improvement, clinical research, and quality improvement research: opportunities for integration. Pediatr Clin North Am 2009; 56:831-41.^{), (17}17. Marshall M, Pronovost P, Dixon-Woods M. Promotion of improvement as a science. Lancet 2013; 381:419-21.^{), (18}18. The Health Foundation. Evidence scan: Improvement Science. London: The Health Foundation; 2011.. In this sense, Improvement Science also sees potential for closer contact between "implementers" of local healthcare improvement interventions and researchers involved in the production of generalizable knowledge concerning such interventions.

Context is crucial to interventions. Healthcare organizations are open sociotechnical systems in which the degree of complexity in the introduction of changes is conditioned by the nature of their technical work (more or less amenable to standardization), internal and external power relations (more or less concentrated), cultural characteristics (beliefs, values, rituals, and practices that generate behavior patterns), and characteristics of the setting.

Our review pointed to the articulation, in the scope of Improvement Science, of quality management, health services research, epidemiology, program evaluation, psychology, and social sciences. Other disciplines could certainly be added, but we believe that the ones addressed here, combined with what they themselves bring from other fields, provide substantial backing for Improvement Science. We should thus not shrink from the persistent challenge involved in the articulation and synthesis of such different visions, coming from disciplines that still appear in fragmented and often contradictory forms. Among the challenging questions for Improvement Science, some are suggested as its amplitude is captured and compromise between pragmatism ans scientific rigor is searched.

An adequate balance between standardization and customization in healthcare quality improvement processes should be pursued wisely, avoiding both the assumption that each case is absolutely unique and, at the other extreme, that an intervention is always the same, regardless of the context. This concern is valid for healthcare quality improvement interventions with a direct focus on patients, health professionals, the organization, or any other level. While all individuals or organizations essentially have their own specificities, healthcare quality improvement depends on the systemization of generalizable knowledge based on an understanding of how mechanisms of change act in classifiable cases. It is thus important, in the description of interventions, to identify both essential and more peripheral components, as well as highly context-sensitive components.

It is also important to continuously mature a way of building of generalizable knowledge based on local healthcare quality improvement processes. The path identified here is that of theoretical formulation defined a priori and testing of hypotheses concerning mechanisms of change and their robustness in the face of diverse conditions ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4.^{), (17}17. Marshall M, Pronovost P, Dixon-Woods M. Promotion of improvement as a science. Lancet 2013; 381:419-21.. However, this path is not entirely linear, and much progress is still needed in actually incorporating, as proclaimed, theoretical backing for healthcare improvement. Meanwhile, randomized clinical trials are still important in their capacity to infer causality, but are often inefficient in grasping contextual effects, thus highlighting the need for methods capable of compensating for this limitation ¹²12. Berwick DM. The science of improvement. J Am Med Assoc 2008; 299:1182-4..

In short, there is still a considerable distance between progress in scientific knowledge on best healthcare practices and the care that is actually provided to patients. Using established knowledge and methods, Improvement Science seeks to explain and shorten this distance. It proposes the construction of a theoretical and methodological framework that assists the design, implementation, evaluation, dissemination, and sustainability of quality improvement. This is probably the main contribution and innovation of Improvement Science.

Acknowledgments

M. C. Portela, M. Martins and C. Travassos are fellows of the Brazilian National Research Council (CNPq). This study resulted partially from M. C. Portela senior fellowship at the University of Leicester, funded by the Science Without Borders Program (grant n. 17943-12-4), provided by Capes.

References

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