how to make changes in healthcare application
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How to make changes in healthcare application

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Of the eight iterative cycle articles that did not report individual cycle sample sizes, two did not differentiate sample sizes between cycles and instead gave an overall sample for the chain of cycles and six did not report sample size. Only five articles describing iterative cycles explicitly reported individual cycle duration.

Twenty-two articles reported more than one change being tested within a single cycle. All studies used a form of qualitative and quantitative data to assess cycles. Of the 15 articles that used regular data, only 7 used monthly or more frequent data intervals see online supplementary figure S3 for full frequency of regular quantitative data reporting.

No studies reported using statistical process control to analyse data collected from PDSA cycles. Eleven included analysis of data using inferential statistical tests five of these studies collected isolated data, six involved continuous data collection. Of the eight articles that did not report any quantitative data, two reported that quantitative analyses had taken place but did not present the findings and six described the use of qualitative feedback only one non-regular, five single data point.

Qualitative data were gathered through a range of mechanisms from informal staff or patient feedback to structured focus groups. PDSA cycles offer a supporting mechanism for iterative development and scientific testing of improvements in complex healthcare systems.

A review of the historic development and rationale behind PDSA cycles has informed the development of a theoretical framework to guide the evaluation of PDSA cycles against use of iterative cycles, initial small-scale testing, prediction-based testing of change, use of data over time and documentation.

Using these criteria to assess peer-reviewed publications of PDSA cycles demonstrates an inconsistent approach to the application and reporting of PDSA cycles and a lack of adherence to key principals of the method. Assessment of compliance was problematic due to the marked variation in reporting of this method, which reflects a lack of standardised reporting requirements for the PDSA method.

From the articles that reported details of PDSA cycles it was possible to ascertain that variation is inherent not just in reporting standards, but in the conduct of the method, implying that the key principles of the PDSA method are frequently not followed. These results suggest that the full benefits of the PDSA method would probably not have been realised in these studies.

Without an iterative approach, learning from one cycle is not used to inform the next cycle, and therefore it is unlikely that interventions will be adapted and optimised for use in a particular setting. Overall these results demonstrate poor compliance with key principles of the PDSA method, suggesting that it is not being used optimally. These comments may provide insight into an important potential misunderstanding of the PDSA methodology.

Ineffective changes will result in learning, which is a fundamental principle behind a PDSA cycle. However minor this abandoned trial may have been, it can still be usefully described as a PDSA cycle. A minor intervention may be planned P and put into practice D. A barrier may be encountered S , resulting in a decision being made to retract the intervention, and to do something differently A. The theoretical framework presented in this paper highlights the complexity of PDSA cycles and the underpinning knowledge required for correct application.

This review did not compare the effectiveness of use to reported outcomes and therefore this study does not conclude whether better application of the PDSA method results in better outcomes, but instead draws on theoretical principles of PDSAs to rationalise why this would be expected. Prospective mechanistic studies exploring the effective application of the method as well as study outcomes would be of greater use in drawing conclusions regarding the effectiveness of the method. The framework presented in this paper could act as a good starting point for such studies.

The fact that only peer-reviewed publications were assessed in this study means that results may be affected by publication bias. This is anticipated both in terms of what is accepted for publication but also the level and type of detail that is requested and allowed in typical publications eg, before and after studies are more common than presenting data over time and this may make these types of studies easier to publish.

Though QI work may be easier to publish now through recent changes in publication guidelines, 27 possible publication outlets continue to be relatively limited. To support systematic reporting and encourage appropriate usage, we suggest that reporting guidelines be produced for users of the PDSA method to increase transparency as to the issues that were encountered and how they were resolved. While PDSA is analogous to a scientific method, it appears to be rarely used or reported with scientific rigour, which in turn, inhibits perceptions of PDSA as a scientific method.

Such guidelines are essential to increase the scientific legitimacy of the PDSA method as well as to improve scientific rigour or application and reporting. Consistent reporting of PDSA structure would allow meta-evaluation and systematic reviews to further build the knowledge of how to use such methods effectively and the principles to apply to increase chances of success.

It is clear from these findings that there is much room for improvement in the application and use of the PDSA method. Previous studies have discussed the influence of different context factors on the use of QI methods, such as motivation, data support infrastructure and leadership 20 , 22 , 41—43 Understanding how high-quality usage can be promoted and supported needs to become the focus of further research if such QI methods are going to be used effectively in mainstream healthcare.

There is varied application and reporting of PDSAs and lack of compliance with the principles that underpin its design as a pragmatic scientific method. There is an urgent need for greater scientific rigour in the application and reporting of these methods to advance the understanding of the science of improvement and efficacy of the PDSA method.

The PDSA method should be applied with greater consistency and with greater accordance to guidelines provided by founders and commentators 25 , 30 , 44 , The authors would like to thank Dr Thomas Woodcock for his valuable input into the theoretical framework and data analysis.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author s and has not been edited for content.

Competing interests The authors declare no conflict of interest. Provenance and peer review Not commissioned; externally peer reviewed. Skip to main content. Log in via OpenAthens. Log in using your username and password For personal accounts OR managers of institutional accounts. Forgot your log in details? Register a new account?

Forgot your user name or password? Search for this keyword. Advanced search. Latest content Current issue Archive Authors About. Log in via Institution. You are here Home Archive Volume 23, Issue 4 Systematic review of the application of the plan—do—study—act method to improve quality in healthcare. Email alerts. Article Text. Article menu. Systematic review. Systematic review of the application of the plan—do—study—act method to improve quality in healthcare.

Abstract Background Plan—do—study—act PDSA cycles provide a structure for iterative testing of changes to improve quality of systems. Statistics from Altmetric. PDSA Quality improvement methodologies Implementation science Quality improvement Introduction Delivering improvements in the quality and safety of healthcare remains an international challenge.

Use of PDSA cycles in healthcare Despite increased investment in research into the improvement of healthcare, evidence of effective QI interventions remains mixed, with many systematic reviews concluding that such interventions are only effective in specific settings. View this table: View inline View popup. Table 1 Description of the plan—do—study—act PDSA cycle method according to developers and commentators.

Data items A theoretical framework was constructed by compartmentalising the key features of the PDSA method into observable variables for evaluation table 2. Risk of bias in individual studies The present review aimed to assess the reported application of the PDSA method and the results of individual studies were not analysed in this review.

Risk of bias across studies Despite our review being focused on reported application, rather than success of interventions, it may still be possible that publication bias affected the results of this study.

Results Study selection A search of the databases yielded articles. Healthcare discipline to which method was applied This varied across acute and community care and clinical and organisational settings. Figure 3 Iterative nature of cycles for all articles and split by plan—do—check—act and plan—do—study—act terminology. Complexity Twenty-two articles reported more than one change being tested within a single cycle. Discussion PDSA cycles offer a supporting mechanism for iterative development and scientific testing of improvements in complex healthcare systems.

Conclusions There is varied application and reporting of PDSAs and lack of compliance with the principles that underpin its design as a pragmatic scientific method. Acknowledgments The authors would like to thank Dr Thomas Woodcock for his valuable input into the theoretical framework and data analysis. Does improving quality save money. A review of evidence of which improvements to quality reduce costs to health service providers.

London : The Health Foundation , Walshe K , Freeman T. Effectiveness of quality improvement: learning from evaluations. Qual Saf Health Care ; 11 : 85 — 7. Evidence for the impact of quality improvement collaboratives: systematic review. BMJ ; : — 4. Systematic review of the application of quality improvement methodologies from the manufacturing industry to surgical healthcare. Br J Surg ; 99 : — Berwick DM.

Developing and testing changes in delivery of care. Ann Intern Med ; : — 6. Getting evidence into practice: the meaning of context. J Adv Nurs ; 38 : 94 — The influence of context on quality improvement success in health care: a systematic review of the literature. Milbank Q ; 88 : — No magic bullets: a systematic review of trials of interventions to improve professional practice.

CMAJ ; : OpenUrl Abstract. Department of Health. London : Department of Health , Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q ; 82 : — Plsek PE , Wilson T. Complexity science: complexity, leadership, and management in healthcare organisations. BMJ ; : Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.

Implement Sci ; 4 : Report No. Quality improvement: theory and practice in healthcare. Walshe K. Understanding what works—and why—in quality improvement: the need for theory-driven evaluation. Int J Qual Health Care ; 19 : 57 — 9. Evidence-based quality improvement: the state of the science.

Health Aff ; 24 : — The tension between needing to improve care and knowing how to do it. N Engl J Med ; : — Quality improvement science and action. Circulation ; : — An intervention to decrease catheter-related bloodstream infections in the ICU. Large scale organisational intervention to improve patient safety in four UK hospitals: mixed method evaluation. BMJ ; : d Ann Intern Med ; : — Thus, in SSM it is important to gain perspectives from different stakeholder groups, e.

Different methods and information sources may be used to gain an understanding about the situation. More interactive methods such as focus groups or workshops can facilitate the creation of a common understanding about the situation and the objective of change.

However, focus groups, especially if performed with mixed stakeholder groups, pose a challenge when it comes to power structures. Groups of members with differing levels of power e.

A basis of this activity, and in SSM in general, is that no perspective is more or less important and that minority opinions or opinions not in agreement with the official line should not be disregarded. Also, participation from all relevant stakeholders should be facilitated and encouraged.

Thus, attention needs to be paid to the power structures in the SSM process just as in focus groups. In addition to eliciting the perspectives from different stakeholders, it is also important to investigate different perspectives of the problematical situation. This involves analyses of: 1. This activity helps to define the problematical situation, allowing different perspectives to be considered.

The gathered information, e. Example of a rich picture. Legend: The picture illustrates the interlinked relationships influencing implementation of evidence-based guidelines in a hospital.

The picture is based on Figure 3. This activity involves creating a conceptual model of one or more aspects of the problematical situation outlining a set of purposeful activities relevant to the situation. A model can only be based on a single declared worldview and thereby represents one way of looking at a complex reality. The model is not intended to be a perfect model to be implemented but used as a basis for discussion and learning about the problem situation and potential ways to improve it.

SSM theory articulates several tools for use by its adherents see Table 1 for terms in order to facilitate the formulation of PAMs. One such tool is the root definition, which is a statement describing the activity system to be modelled.

Formulation of root definitions can be helped by using the PQR formula which answers the questions: what should be done P , how should it be done Q and why should it be done R. A PAM, and the learning and discussions based on the model, should include a specific set of information in order to be comprehensive enough to guide further work. The C stands for customer e. The A is for the actors e. The T depicts for transformation and represents the process by which inputs are converted to outputs.

The O is the owner of the system and includes people and roles that can change or stop the transformation process e. It is worth noting that people and roles can fall into more than one group. It is useful to think about how to assess the outcomes of the PAMs and formulate criteria for efficacy, efficiency and effectiveness the three Es in SSM language. This helps to guide continuous monitoring of the progress of an intervention which in turn provides information enabling relevant control actions to be taken to improve the system activities and the outcomes.

An illustrative example of a PAM. Legend: The PAM outlines a generic process for implementation of evidence-based guidelines into practice in a hospital setting. In this third activity, the information gained from developing the rich picture together with the PAM is used to organise a discussion about potential improvements.

The simulated model of the world helps illuminate differences between the way the stakeholders are constructing the world the PAM , and the problem situation, which enables the questions that will ultimately lead to change. The simulated model should not be viewed as a perfect model but simply as a device to structure discussion about improvements. The focus should be on both:. The aim of this third activity is to find changes that can lead to improvements and that are contextually and culturally feasible in the specific situation.

It also aims to acknowledge the conflicting views in health care — doctors, nurses, allied health practitioners, managers, patients and policymakers all differ in their perspectives from each other, and to accommodate these divergent views. This activity involves identifying opportunities for improvement based on the previous activities.

It then proceeds to testing changes as a basis for further learning amongst stakeholders involved in the change. The testing is done iteratively to challenge and adapt the improvement intervention.

This iterative testing is facilitated through monitoring of progress and by taking control actions based on this. SSM is a continuous learning process and since services and organisations are under continuous development and variables are in constant motion, problem-solving processes and improvement efforts must be flexible and accommodating to real world fluidity and dynamism Fig. Illustrates a generic SSM learning cycle with all four activities outlined.

A generic SSM learning cycle. Legend: Source: Checkland and Poulter [ 19 ]. Permission granted by John Wiley and Sons for use of this image. Licence number: SSM has been used in a range of different fields [ 24 ]. However, it has lagged in healthcare, for reasons that are not completely clear. We found articles on SSM in the multidisciplinary database, Scopus, but only 21 empirical studies conducted in healthcare in PubMed, the health and medical database.

The identified papers show that when SSM has been applied in healthcare, it has been used as a structured way of analysing problematical situations alone e. When it has been used, it has been applied in several different healthcare settings including: acute care, community care, child and adolescent care, emergency care, mental health, and palliative care. Table 3 provides some specific examples of how SSM has been used for healthcare improvements. Furthermore, the examples show that SSM has been applied in different ways, e.

However, the studies also highlight limitations in the empirical evidence for the use of SSM in healthcare. SSM has most often been used to structure a problem and to make recommendations for improvements but to a lesser extent to take action to improve and evaluate the outcomes from this. Of the identified studies, only three [ 29 , 30 , 36 ], mentioned implementation of the proposed improvements and of those only two presented the outcomes of the implementation in subsequent papers [ 35 , 37 ].

It seems that SSM has been considered most useful in the initial stages of an improvement process, when defining the problem situation and exploring potential solutions and less useful in the process of putting these improvement suggestions in place. Without the next step of evaluating the implementation and outcomes of the improvements it is difficult to fully assess the usefulness and effectiveness of SSM for healthcare improvement.

With growing understanding of healthcare as a complex adaptive system [ 38 , 39 ] not amenable to linear, top-down change strategies [ 11 ], it is timely to revisit the potential importance, and utility, of SSM. We propose that using SSM as this structured, multifaceted approach has the potential to facilitate contextually adapted improvements in healthcare by: involving stakeholders affected by change and with expertise about the local context, facilitating contextualization of improvement interventions to the local context, taking a systems approach to assess and address the nominated situation, and by approaching improvements in an iterative learning cycle.

Below we outline our proposed key principles for the use of SSM in healthcare in future. Any successful intervention requires individuals to change behaviour in some way [ 44 ]. As Greenhalgh et al.

This means that the individuals involved can make or break an intervention and that it is vital to include them in the process. We must not treat them as subjects but participants. This is in line with the emergence of partnership research [ 45 ] and models of collaboration, and co-production of knowledge in healthcare which emphasise that knowledge is generated within its context of use [ 46 , 47 , 48 ].

A core component of SSM is that it proposes a collaborative approach to problem solving and change management. It explicitly seeks to collect different views of a problematical situation activity 1 , as well as involving stakeholders in improving the situation activities 2—4. This helps to highlight varying views of the situation, the dimensions of the intervention, and to take different perspectives into consideration.

In the case we make above, context matters, and an intervention that is adapted to fit the local circumstances is more likely to be successful and sustained [ 2 , 40 , 51 , 52 ]. Thus, there are good reasons to consider how improvement interventions could be contextualized. SSM facilitates this in two ways. First, the participatory approach involves different stakeholders with unique context knowledge who use this knowledge to analyse the problematical situation and contribute to change management.

Second, the systems thinking associated with SSM implies that the whole system is taken into consideration rather than looking at individual components in isolation. This facilitates alignment between different parts of the systems and decreases the risk of making changes that have unintended and unwanted consequences for other parts of the system. Similarly, it can help to illuminate the processes and systems that are already in place and working, in order to take advantage of these when making improvements, e.

The dynamic and changing nature of healthcare organisations and the context in which they subsist necessitate continuous adaptation and refinement of interventions [ 40 ]. Yet another argument for continuous adaptation is that it is often impossible to take every potential problem and influencing factor into consideration prior to implementation. This calls for a move away from the traditional methods of evaluating interventions where processes and outcomes are evaluated months or years after initial implementation, towards the use of rapid feedback loops to assess intervention progress [ 40 , 41 , 42 ].

SSM addresses this by engaging participants in an iterative process of assessing their local context, making improvements and then doing things again. Within the SSM paradigm, the learning process is continuously monitored to assess progress and problems so that relevant control actions can be taken to refine or change the implementation and the intervention. The process of SSM also has the potential to facilitate organisational learning. By involving different stakeholders, knowledge sharing and knowledge creation as well as the development of shared meaning and understanding across individuals and groups are enabled [ 53 , 54 ].

The involvement of organisational members in analysing, developing and testing improvements can facilitate a culture that supports experimentation, where people are comfortable with questioning current practices and encouraged to explore new ideas and innovations [ 53 ].

Finally, by engaging stakeholders in the improvement process they learn about how to use a structured approach to making improvements, which can be applied in future improvement efforts. SSM entails both similar and unique features when compared with other approaches to organisational improvement. One example is the investigation of the context in which the problem situation is located, an important first activity in SSM. In this sense it is similar to implementation determinant frameworks e.

However, these approaches generally provide guidance, e. SSM on the other hand uses pictures or diagrams to explore the context so that links between different parts can be identified. This may help avoid seeing influencing factors and parts of the system as separate from each other.

SSM also has similarities to other approaches when it comes to managing change in an iterative learning cycle. For instance, Plan-Do-Study-Act [ 56 ], Dynamic Sustainability Framework [ 40 ] and Normalization Process Theory [ 57 ] all entail this component and few scholars or practitioners dealing with change in healthcare, believe that it is a straightforward process. What distinguishes SSM is that it uses system thinking to create models that can be used to learn about the situation in need of improvement and helps to explore and decide on feasible and desirable changes.

Another difference is that while implementation approaches are focused on describing or guiding the implementation process, understanding influences of implementation and evaluating implementation [ 8 ], SSM is more focused on the problem structuring. As such, SSM may be especially suited for ill-defined problems and can help assist in defining the intervention to be implemented and therefore contribute to the step before actual implementation. Thus, it may be used to complement implementation approaches.

We have argued that SSM can be used to engage stakeholders in a collaborative process of making contextualized improvements and have outlined key principles for this.

As to limitations, while SSM involves aspects that are important for implementation, e. This may be one reason why the identified studies mainly applied SSM as a way to structure problems and come up with suggestions for improvements and to a much lesser extent for implementation of the improvement actions.

Another limitation is the relatively low number of empirical studies which makes it challenging to draw conclusions about the impact of SSM in healthcare. The technicalities of SSM can make it difficult to appreciate and apply, especially for people who are not used to systems modelling or SSM language.

Application often requires facilitation by an SSM expert from inside or outside of the organization who is familiar with the process and SSM tools and mechanisms [ 58 , 59 ]. Thus, SSM application will often require experience or technical support. Furthermore, since it is a participatory approach it requires the organisation and the individuals in it to be invested in the process for it to be worthwhile. To ensure support and build trust and understanding with involved practitioners it is important to secure allocated time, arenas for interactions as well as skills in project management and communication [ 60 ].

Finally, we do not provide a detailed guide for how to use SSM. For this we refer to the books by Checkland and colleagues on the topic e. Complex systems like healthcare require multi-faceted solutions.

The time for attempting change via unsophisticated, linear, top-down means in complex health settings is surely over. We have put forward the case for using SSM to re-energise the way we manage change in healthcare and highlighted participation, contextualization, taking a systems approach, factoring in complexity thinking, and embracing continuous adaptation and learning as key principles for change which can be facilitated by applying SSM logic, tools and approaches.

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study. Dissemination and implementation research in health: translating science to practice. New York: Oxford University Press; Google Scholar. Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q. Article Google Scholar. Knowledge translation of research findings. Implement Sci. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients' care.

The struggle of translating science into action: foundational concepts of implementation science. J Eval Clin Pract. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Understanding the conditions for improvement: research to discover which context influences affect improvement success.

BMJ Qual Saf. Nilsen P. Making sense of implementation theories, models and frameworks. Systems thinking for health systems strengthening. Alliance for Health Policy and Systems Research. Geneva: World Health Organization; Greenhalgh T. How to implement evidence-based healthcare. Oxford: Wiley Blackwell; When complexity science meets implementation science: a theoretical and empirical analysis of systems change.

BMC Med. Leadership, innovation climate, and attitudes toward evidence-based practice during a statewide implementation. Context matters: measuring implementation climate among individuals and groups.

Implementation, context and complexity. Implementing clinical guidelines: current evidence and future implications. J Contin Educ Health. Why don't physicians follow clinical practice guidelines?

Checkland P. Systems thinking, systems practice. Chichester: John Wiley and Sons; Soft systems methodology: a year retrospective. Syst Res Behav Sci. Checkland P, Poulter J. Learning for action: a short definitive account of soft systems methodology and its use, for practitioners, teachers and students. John Wiley and Sons Ltd: Chichester; Hindle D, Braithwaite J. Sydney: Centre for Clinical Governance Research. Sydney: University of New South Wales; Soft systems methodology in action.

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