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Total quality management in the health-care context: integrating the literature and directing future research

Majdi m alzoubi.

1 Department of Community Health, Faculty of Medicine and Health Sciences, University Putra Malaysia, UPM Serdang, Selangor Darul Ehsan, 43400, Malaysia

ZM Al-Hamdan

2 Department of Nursing Management, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan

Synergistic integration of predictors and elements that determine the success of total quality management (TQM) implementations in hospitals has been the bane of theoretical development in the TQM research area. Thus, this paper aims to offer a systematic literature review to provide a foundation on which research on TQM can be built and to identify the predictors of successful TQM in the health-care context.

Materials and methods

A systematic literature survey was adopted in this paper, involving the review of 25 relevant researched articles found in the databases Science Direct, EBSCO, MEDLINE, CINAHL and PubMed.

The systematic literature survey reveals five variables to be core predictors of TQM, signifying how important these variables are in the successful implementation of TQM in the health-care context. Also, it is revealed that the identified core predictors have positive effects on an improved health-care system. However, the systematic survey of the literature reveals a dearth of studies on TQM in the health-care context.

As TQM has become an important management approach for advancing effectiveness in the health-care sector, this kind of research is of value to researchers and managers. Stakeholders in the health sectors should introduce and implement TQM in hospitals and clinics. Nevertheless, this study has limitations, including that the databases and search engines adopted for the literature search are not exhaustive.


Given the snowballing global economic competition and other external pressures, organizations have been compelled to pursue enduring quality and quality management which will, in turn, enhance their competitive advantage. Quality as a concept has metamorphosed over the years, and it involves objective quality bordering on the characteristics and quality of goods and services that meet implicit and explicit customer demands. It also includes subjective quality which denotes the capability to produce goods and services in the best, effective and efficient manner. 1

Looking at the health-care context, quality has always been aimed at since the time of Florence Nightingale. 2 Given that quality assurance is a requisite for economic survival, 3 and that it is an ethical, legal and social rights matter, 4 the health sector has been worried about it for more than a decade .2 Quality assurance is significant as it concerns customer satisfaction and the reduction of risks connected with health care to a minimum. 5 In the present time, health care has become a developing profession with an approach to care quality via the appraisal and regulation of structure, process and care result components. 6

Given the ever-increasing competitive and dynamic environment in which hospitals operate, and the need to augment hospitals’ performance and health-care quality, researchers 2 , 7 – 9 have conducted considerable research on enhancement of health-care quality. Moreover, given that nurse performance is crucial to the overall performance of the hospital and effective health-care system, there has been a research focus on nurse performance. 7 Nurses represent a large percentage of the health workers in any hospital. Nurses would play a significant role in the implementation of any intervention programs introduced by any hospital.

Moreover, research 8 – 11 has shown that the health-care system is facing a myriad of challenges which include high care cost, swiftly increasing dependence on technology, economic pressure on health organizations, reduction in health-care quality, 8 , 10 fulfillment of patients’ needs, 9 augmented numbers of patients who are suffering from multiple illnesses, increased demand for high-quality care, increased health-care costs and cost-containment pressures (Organization for Economic Cooperation and Development [OECD] 2007). 11 Some studies have indicated that an active way of surmounting health-care challenges is through an intervention program that will border on quality management (eg, total quality management [TQM]). 12

TQM is a system implemented by the management of an organization to achieve the satisfaction of customers/patients .13 The importance of TQM as a strategy to improve organizational performance has grown in this era of globalization. 14 Numerous research has revealed the role of TQM in the enrichment of system quality and enhancement of both employee and organizational performance. TQM is known for continuous quality improvement, quality management and total quality control. 10 TQM is held to be an innovative approach to the management of organizations. In the medical sector, TQM integrates quality orientation in all processes and procedures in health-care delivery .15 It is now being widely adopted in the medical sector of many countries. The research by Vituri and Évora 2 indicates that the literature on TQM in health sectors reveals that TQM has been fully adopted in some health institutions.

The implementation of TQM, upon which the success of TQM hinges, is intricate and complex; it depends on a good combination of certain predictors (ie, critical success factors [CSF]), and its benefits are difficult to accomplish .16 Different means of integrating predictors of TQM, although inconsistent, have emerged in the literature. 17 Some predictors have been considered crucial to TQM success, 18 and thus the exceptional predictors which can be adopted by organizations, irrespective of their industry, type, size or location. 19 These predictors are regarded as the determinants of firm performance via effective implementation of TQM.

Nevertheless, synergistic integration of predictors and elements, otherwise known as CSFs and which determine the success of TQM implementation, has been the bane of theoretical development in the TQM research area. Some of these predictors have been reported, by extant studies, 20 to have a positive impact on performance.

Likewise, substantive problems exist and can hamper theoretical development in the research area. The literature lacks foundation and structure on which the research on TQM in the health-care context is based, and connections between studies on TQM in the health-care context can hardly be drawn. The current state of extant research on TQM in the health-care context indicates that there is a need for more research in the area. 21 New knowledge development regarding identification of fitting predictors for successful TQM that enhance effectiveness in the health-care sector should be developed and where further research needs to be done should be identified.

Considering the extant works on a systematic literature review on predictors of TQM, two English written studies 14 , 22 are discernible, but Hietschold et al 14 focused on CSFs of TQM in general contexts while Aquilani et al 22 focused on the identification of TQM research, implementation of TQM research and impact-of-TQM-on-performance research in general contexts. Besides these two studies, no studies have focused on the systematic literature survey of predictors/elements of TQM in the health-care context.

Therefore, undertaking a systematic literature review in this aspect of research is germane, and this paper is poised to do as such. This paper conducts a systematic literature survey to provide a foundation stone on which research on TQM in the health-care context can be built, to evaluate the current state of evidence for TQM in the health-care context, to reveal inadequacies in the literature and to point to where further research needs to be done.

This research is guided by the following research question: what are the predictors of successful TQM in the health-care context between the period of 2005 and 2016? Like the two previous studies on a systematic literature review of TQM, this paper adopts and applies the three core steps of planning, execution and reporting that constitute a systematic literature survey. 23

This research seeks to obtain the most important predictors of successful TQM in the health-care context. This includes the review of published peer-reviewed works in English-language journals, which were published between 2005 and 2016. The literature was sourced from Science Direct, EBSCO, MEDLINE (Medical Literature Analysis and Retrieval System Online), CINAHL (Cumulative Index of Nursing and Allied Health Literature) and PubMed (US National Library of Medicine).

As part of the process of systematic literature analysis in this paper, a structured search of the academic literature was conducted to find published articles that identified TQM, total quality management, implementation, CSFs, health care and nursing. The keywords used in the search are TQM, total quality management, implementation, critical success factors, health care and nursing.

As presented in Figure 1 , a search of Science Direct, MEDLINE, EBSCO, CINAHL and PubMed yielded 2133, 6341, 1867, 7 and 474 articles, respectively. Then, repeated citations, dissertations and case studies were deleted. Via reading of the title and abstract, the remaining articles were narrowed down by relevance. Only peer-reviewed academic and practice articles that focus on total quality management, implementation, CSFs health care and nursing were selected. This exercise yielded a total of 475 articles which were published between 2005 and 2016.

An external file that holds a picture, illustration, etc.
Object name is RMHP-12-167-g0001.jpg

Consort flow chart of systematic review method.

Abbreviation: TQM, total quality management.

Furthermore, inclusion and exclusion criteria were applied to narrow down the yielded articles. The inclusion criteria involved articles which were written in English language and published between 2005 and 2016, articles that dwell on implementation and critical factors clearly, articles from any geographical location which examined TQM, TQM principles, TQM tools and methods in the context of the health-care sector, and TQM studies that used a quantitative research approach and quasi-experimental research design. The exclusion criteria involved articles which are written in non-English language and published before 2005 or after 2016, studies in which the population and sample were not health-care workers practicing inside hospitals, gray literature or works that are not published in a peer-reviewed journal, dissertations/theses, proceedings, published abstracts, studies with qualitative research methods, and commentary articles written to convey opinion or stimulate research or discussion, with no research component. By employing these inclusion and exclusion criteria, 20 articles were generated. Moreover, to guarantee all-inclusiveness and to widen the scope of the review, a forward and backward search of citations in articles was conducted. This was recognized via the database searches, and 25 articles were finally selected. Thereafter, the 25 generated articles were fully perused.

Likewise, for exhaustive research, the approach adopted in this paper also involved the identification and measurement of predictors (CSFs) of TQM. This was done by identifying the most common or important predictors in the selected 25 works that analyze the existing models and/or scales in other contexts, industries or countries. It also includes recognition of the papers that investigate the influence of TQM implementation and/or the impact of predictors of TQM on performance. Additionally, for a proper review of the selected works, adequate plotting of the development of the line of reasoning, integrating and synthesizing the studies, authors, study design, study population, variables, measures of variables and findings of each selected article were identified and noted down. Figure 1 represents the consort flow chart of the systematic review method.

Findings and discussion

Altogether, 25 researched articles were eventually reviewed. All of the selected 25 articles are based on empirical evidence, although a possible limitation of this systematic review strategy might be the exclusion of qualitative studies in the research. Based on Table 1 , five predictors were identified. These are presented in Table 2 .

Matrix of the reviewed literature

Abbreviations: HR, human resources; TQM, total quality management.

TQM predictors in the reviewed studies

The researched literature on predictors of successful TQM implementation was found to be from various countries but in the same health sector. While some predictors adopted by a few of the researched studies were identified, the most frequent and core predictors were identified and considered. As depicted in Table 2 , education and training, continuous quality improvement, patient focus/satisfaction, top management commitment and teamwork appear to be the core predictors (CSFs) in this review. This finding validates how important these variables are in the successful implementation of TQM in the health-care context.

It is noteworthy that the core predictors (ie, education and training, continuous quality improvement, patient focus/satisfaction, top management commitment and teamwork) identified in this study were among the variables found to be central and frequently used CSFs in the previous systematic-review-based studies. 14 , 21 This validates and confirms the findings of the previous studies.

Moreover, it is found that the most adopted research method in TQM in the health-care context is cross-sectional research; 56% of the reviewed researched articles 41 – 46 used a cross-sectional research design, but 32% of the studies employed a quasi-experimental research approach. This indicates that there is still a need for more research on TQM in the health-care context which will adopt a quasi-experimental research approach, because quasi-experimental research design can be very useful in recognizing general trends from the results, and reduces the difficulty and ethical worries that may be connected with the pre-selection and random assignment of test subjects. On the geographical location aspect, the result of this analysis showed that 28% of the reviewed studies were conducted in Iran while 20% of the reviewed studies were conducted in Jordan; 12% and 8% of the reviewed studies were conducted in Saudi Arabia and Pakistan, respectively. The other studies, 4% each, came from India, Namibia, Turkey, the United States, France and Mauritius.

With regards to the influence of predictors on performance in the researched studies, it is found that all of the selected articles 47 , 48 , 49 , 50 ,. 51 that examined the effects of the core predictors (continuous quality improvement, education and training, patient focus/satisfaction, top management commitment and teamwork) of TQM indicate a positive effect of TQM in the health-care sector.

More so, the findings of this review signify that predictors of TQM implementation will result in higher levels of nurse performance .51 In addition, the literature and empirical evidence have shown that TQM in an organizational process always results in better performance of the organization. TQM focuses on patient satisfaction, organization problem identification, building and promotion of open decision-making among employees. It embraces a holistic strategy that gives room for every worker to share responsibility for the quality of the work done. It makes use of analytical mechanisms, such as flow and statistical charts and checksheets, to gather information about activities in an organization. 52 In the medical sector, TQM aims at embedding orientation of quality in all processes and procedures in the delivery of health services .15

Nevertheless, this literature survey is not an exhaustive review of the literature on TQM as it solely focused on the effect of TQM. Future research should widen the scope of this paper by including studies conducted in other contexts (eg, education, manufacturing, etc) and studies that use different research methods (eg, longitudinal research method, randomized control trial method). While TQM predictors have increased in number to reach a total of 59 TQM practices, 21 TQM predictors in the context of health care are few but growing. Investigating the nature of TQM predictors and the methods used in examining them indicates that researchers may have been keen in searching for new predictors instead of trying to cluster them and identify those that are critical for successful TQM implementation. In addition, research on TQM predictors in the health-care sector is scanty, as noted previously.

Practically, given the identified core TQM predictors in this study, it is evident that hospitals’ management should consider entrenchment of continuous quality improvement, education and training, patient focus/satisfaction top management commitment and teamwork in the implementation of TQM, which will consequently enhance hospital performance. Given that TQM predictors are many and some of them have been considered core in several specific contexts, industries, dimensions, etc, it is held that stakeholders in different sectors/industries should begin to identify the most vital TQM practices that suit their situations, goals, strategies and expected performances.

Conclusion and recommendations

As TQM has become an important management approach for advancing performance, this kind of research is of value to researchers and managers. Nevertheless, this study has limitations, including that the databases and search engines adopted for the literature search are not exhaustive. Although a good number of keywords are used, there can be other likely keywords that can be included.

This work has contributed to the enrichment of the relevant literature and made theoretical and methodological contributions. It has provided a foundation on which research on TQM can be built via review of the work done between 2005 and 2016, plotting the development of the line of reasoning, and integration and synthesis of studies from TQM in the health-care context. It has also contributed by evaluating the current state of evidence regarding TQM, indicating inadequacies in the literature and pointing to where further research needs to be done. Thus, it contributes to the present body of knowledge as well as the research on TQM in the health-care context.

This work has also established that the most adopted research method in health-care-based TQM is cross-sectional research, followed by quasi-experimental research, and the researched studies were mostly conducted in Asia. The findings of the researched literature indicate a positive effect of TQM in the health-care context, indicating that TQM implementation, which contains the identified core predictors, will result in higher levels of performance. Furthermore, TQM implementation can help health-care professionals to gain more qualified behaviors with total commitment to work toward handling the patients, which in the long run will augment their performance.

The findings of the reviewed studies indicate how it would be useful for stakeholders in the health sectors to introduce and implement TQM in the hospitals and clinics, as this would enhance the performance of the health workers and consequently improve organizational performance. Given the limitations of this work, it is sufficed to suggest that future research should widen the scope of this paper by including studies conducted in other contexts and studies that use different research methods, and it should also develop a comprehensive TQM taxonomy to explain how and why TQM practices coalesce within systems that facilitate higher performance.

The authors report no conflicts of interest in this work.

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Total Quality Management Research Paper Topics

Academic Writing Service

Total quality management research paper topics have grown to become an essential area of study, reflecting the critical role that quality assurance and continuous improvement play in modern organizations. This subject encompasses a wide array of topics, methodologies, and applications, all aimed at enhancing operational efficiency, customer satisfaction, and competitive advantage. The purpose of this text is to provide students, researchers, and practitioners with a comprehensive guide on various aspects of total quality management (TQM). It includes an extensive list of potential research paper topics categorized into ten main sections, a detailed article explaining the principles and practices of TQM, guidelines on how to choose and write on TQM topics, and an introduction to iResearchNet’s custom writing services that cater to this field. This comprehensive resource aims to assist students in navigating the complex landscape of TQM, inspiring insightful research, and offering practical tools and support for academic success.

100 Total Quality Management Research Paper Topics

Total Quality Management (TQM) has evolved to become a strategic approach to continuous improvement and operational excellence. It has applications across various industries, each with its unique challenges and opportunities. Below is an exhaustive list of TQM research paper topics, divided into ten categories, offering a rich source of ideas for students and researchers looking to explore this multifaceted domain.

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Total Quality Management transcends traditional boundaries and integrates concepts from various disciplines. Its goal is to create a culture where quality is at the forefront of every decision and process. The following list presents 100 TQM research topics divided into ten different categories. Each category represents a specific aspect of TQM, providing an extensive foundation for exploring this complex field.

  • Historical Development of TQM
  • Core Principles of TQM
  • TQM and Organizational Culture
  • Deming’s 14 Points: A Critical Analysis
  • Six Sigma and TQM: A Comparative Study
  • TQM in Manufacturing: Case Studies
  • TQM and Leadership: Role and Responsibilities
  • Customer Focus in TQM
  • Employee Involvement in TQM Practices
  • Challenges in Implementing TQM
  • TQM in Healthcare
  • TQM in Education
  • TQM in the Automotive Industry
  • TQM in the Food and Beverage Industry
  • TQM in Information Technology
  • TQM in Hospitality
  • TQM in the Banking Sector
  • TQM in Construction
  • TQM in Supply Chain Management
  • TQM in Government Services
  • Statistical Process Control in TQM
  • The 5S Method in Quality Management
  • Kaizen and Continuous Improvement
  • Root Cause Analysis in TQM
  • Quality Function Deployment (QFD)
  • The Fishbone Diagram in TQM
  • Process Mapping and Quality Improvement
  • Benchmarking for Quality Enhancement
  • The Role of FMEA in Quality Management
  • Design of Experiments (DOE) in TQM
  • ISO 9001 and Quality Management
  • The Benefits of ISO 14001
  • Understanding Six Sigma Certifications
  • The Impact of OHSAS 18001 on Safety Management
  • Lean Manufacturing and Quality Standards
  • Implementation of ISO 22000 in Food Safety
  • The Role of ISO/IEC 17025 in Testing Laboratories
  • Quality Management in ISO 27001 (Information Security)
  • Achieving CE Marking for Product Safety
  • The Influence of SA 8000 on Social Accountability
  • Measuring Customer Satisfaction in TQM
  • The Role of Service Quality in Customer Retention
  • Customer Complaints and Quality Improvement
  • Building Customer Loyalty Through TQM
  • Customer Feedback and Continuous Improvement
  • Customer Relationship Management (CRM) and TQM
  • Emotional Intelligence and Customer Satisfaction
  • The Impact of Branding on Customer Loyalty
  • Customer Experience Management in TQM
  • Customer Segmentation and Targeting in TQM
  • The Role of Training in TQM
  • Employee Empowerment in Quality Management
  • Motivational Theories and TQM
  • Building a Quality Culture Through Employee Engagement
  • Employee Recognition and Reward Systems in TQM
  • Leadership Styles and Employee Performance in TQM
  • Communication and Teamwork in TQM
  • Managing Change in TQM Implementation
  • Conflict Resolution Strategies in TQM
  • Work-Life Balance in a Quality-Oriented Organization
  • Key Performance Indicators (KPIs) in TQM
  • Balanced Scorecard and Quality Management
  • Performance Appraisals in a TQM Environment
  • Continuous Monitoring and Evaluation in TQM
  • Risk Management in Quality Performance
  • Process Auditing and Quality Control
  • The Role of Quality Circles in Performance Evaluation
  • Value Stream Mapping and Process Optimization
  • The Impact of E-business on Quality Performance
  • Outsourcing and Quality Assurance
  • Environmental Sustainability and TQM
  • Social Responsibility and Ethical Practices in TQM
  • Green Manufacturing and Environmental Performance
  • Corporate Social Responsibility (CSR) Strategies in TQM
  • Waste Reduction and Recycling in TQM
  • Community Engagement and Social Impact
  • Sustainable Development Goals (SDGs) and TQM
  • Energy Efficiency and Sustainable Quality Management
  • Ethical Sourcing and Supply Chain Responsibility
  • Human Rights and Labor Practices in TQM
  • TQM Practices in Different Cultures
  • The Influence of Globalization on TQM
  • Cross-Cultural Communication and Quality Management
  • International Regulations and Quality Standards
  • TQM in Emerging Economies
  • Quality Management in Multinational Corporations
  • The Role of WTO in Global Quality Standards
  • Outsourcing and Global Supply Chain Quality
  • Global Competition and Quality Strategies
  • International Collaboration and Quality Innovation
  • Technological Innovations and Quality Management
  • Big Data and Analytics in TQM
  • Quality 4.0 and the Role of IoT
  • Artificial Intelligence and Quality Prediction
  • The Impact of Social Media on Quality Perception
  • Sustainability and Future Quality Management
  • Agile Methodologies and Quality Flexibility
  • Blockchain Technology and Quality Traceability
  • Cybersecurity and Quality Assurance
  • The Future Role of Human Resource in Quality Management

The vast array of topics listed above provides a comprehensive insight into the dynamic and multifaceted world of Total Quality Management. From foundational principles to future trends, these topics offer students a diverse range of perspectives to explore, understand, and contribute to the ongoing dialogue in TQM. With proper guidance, dedication, and an open mind, scholars can delve into these subjects to create impactful research papers, case studies, or projects that enrich the existing body of knowledge and drive further innovation in the field. Whether one chooses to focus on a specific industry, a particular tool, or an emerging trend, the possibilities are endless, and the journey towards quality excellence is both challenging and rewarding.

Total Quality Management and the Range of Research Paper Topics

Total Quality Management (TQM) represents a comprehensive and structured approach to organizational management that seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback. This article aims to provide an in-depth exploration of TQM, shedding light on its evolution, its underlying principles, and the vast range of research topics it offers.

Historical Background

Total Quality Management has its roots in the early 20th century, with the development of quality control and inspection processes. However, it wasn’t until the mid-1980s that TQM became a formalized, systematic approach, greatly influenced by management gurus like W. Edwards Deming, Joseph Juran, and Philip Crosby.

  • Early Quality Control Era : During the industrial revolution, emphasis on quality control began, primarily focusing on product inspection.
  • Post-World War II Era : The concept of quality management grew as the U.S. sought to rebuild Japan’s industry. Deming’s teachings on quality greatly influenced Japanese manufacturing.
  • TQM’s Formalization : The integration of quality principles into management practices led to the formalization of TQM, encompassing a holistic approach towards quality improvement.

Principles of Total Quality Management

TQM is underpinned by a set of core principles that guide its implementation and contribute to its success. Understanding these principles is fundamental to any research into TQM.

  • Customer Focus : At the heart of TQM is a strong focus on customer satisfaction, aiming to exceed customer expectations.
  • Continuous Improvement : TQM promotes a culture of never-ending improvement, addressing small changes that cumulatively lead to substantial improvement over time.
  • Employee Engagement : Engaging employees at all levels ensures that everyone feels responsible for achieving quality.
  • Process Approach : Focusing on processes allows organizations to optimize performance by understanding how different processes interrelate.
  • Data-Driven Decision Making : Utilizing data allows for objective assessment and decision-making.
  • Systematic Approach to Management : TQM requires a strategic approach that integrates organizational functions and processes to achieve quality objectives.
  • Social Responsibility : Considering societal well-being and environmental sustainability is key in TQM.

Scope and Application

Total Quality Management is applicable across various domains and industries. The following areas showcase the versatility of TQM:

  • Manufacturing : Implementing TQM principles in manufacturing ensures efficiency and consistency in production processes.
  • Healthcare : TQM in healthcare focuses on patient satisfaction, error reduction, and continuous improvement.
  • Education : In educational institutions, TQM can be used to improve the quality of education through better administrative processes and teaching methods.
  • Service Industry : Whether in hospitality, banking, or IT, TQM’s principles can enhance service quality and customer satisfaction.
  • Public Sector : Governmental bodies and agencies can also employ TQM to enhance public service delivery and satisfaction.

TQM’s multifaceted nature offers a wide range of research paper topics. Some areas of interest include:

  • TQM Tools and Techniques : Research on tools like Six Sigma, Kaizen, and statistical process control.
  • Quality Standards : Investigating the impact and implementation of ISO standards.
  • Industry-Specific Applications : Exploring how TQM is applied and adapted in different industries.
  • Challenges and Opportunities : Assessing the difficulties and advantages of implementing TQM in contemporary business environments.
  • Emerging Trends : Examining future trends in TQM, such as the integration of technology and sustainability considerations.

Total Quality Management has evolved from a simple focus on product inspection to a strategic approach to continuous improvement that permeates the entire organization. Its application is not confined to manufacturing but has spread across various sectors and industries.

Research in TQM is equally diverse, offering students and scholars a rich and complex field to explore. Whether delving into the historical evolution of TQM, examining its principles, evaluating its application in different sectors, or exploring its myriad tools and techniques, the study of TQM is vibrant and multifaceted.

By undertaking research in Total Quality Management, one not only contributes to the academic body of knowledge but also plays a role in shaping organizational practices that emphasize quality, efficiency, customer satisfaction, and social responsibility. In a global business environment characterized by competitiveness, complexity, and constant change, the principles and practices of TQM remain more relevant than ever.

How to Choose Total Quality Management Research Paper Topics

Choosing the right topic for a research paper in Total Quality Management (TQM) is a crucial step in ensuring that your paper is both engaging and academically relevant. The selection process should align with your interests, the academic requirements, the targeted audience, and the available resources for research. Here is an in-depth guide, including an introductory paragraph, ten essential tips, and a concluding paragraph to help you make an informed choice.

Total Quality Management encompasses a broad spectrum of theories, tools, techniques, and applications across various industries. This richness and diversity offer a plethora of potential research topics. However, selecting the perfect one can be daunting. The following tips are designed to guide students in choosing a research topic that resonates with their interests and the current trends in TQM.

  • Identify Your Area of Interest : TQM has many facets, such as principles, tools, applications, challenges, and trends. Pinpointing the area that piques your interest will help in narrowing down your topic.
  • Consider Academic Relevance : Your chosen topic should align with your course objectives and academic guidelines. Consult your professor or academic advisor to ensure that the topic fits the scope of your course.
  • Research Current Trends : Stay up-to-date with the latest developments in TQM by reading scholarly articles, attending conferences, or following industry leaders. Current trends may inspire a relevant and timely topic.
  • Evaluate Available Resources : Make sure that your chosen topic has enough existing literature, data, and resources to support your research.
  • Assess the Scope : A too broad topic might be overwhelming, while a too narrow one might lack content. Balance the scope to ensure depth without over-extending.
  • Consider Practical Implications : If possible, choose a topic that has real-world applications. Connecting theory to practice makes your research more impactful.
  • Check Originality : Aim for a topic that offers a new perspective or builds on existing research in a unique way. Your contribution to the field should be clear and valuable.
  • Evaluate Your Expertise : Choose a topic that matches your level of expertise. Overly complex subjects might lead to difficulties, while overly simple ones might not challenge you enough.
  • Consider the Target Audience : Think about who will be reading your research paper. Tailoring your topic to the interests and expectations of your readers can make your paper more engaging.
  • Conduct a Preliminary Research : Before finalizing your topic, conduct some preliminary research to ensure there’s enough material to work with and that the topic is feasible within the given timeframe.

Selecting the right topic for a Total Quality Management research paper is a thoughtful and multifaceted process. It requires considering personal interests, academic requirements, current industry trends, available resources, and practical implications.

By following the guidelines provided, students can align their research with both personal and academic objectives, paving the way for a successful research experience. The ideal topic is one that not only aligns with the ever-evolving field of TQM but also resonates with the researcher’s passion and curiosity, laying the foundation for a meaningful and insightful investigation into the dynamic world of Total Quality Management.

How to Write a Total Quality Management Research Paper

Writing a Total Quality Management (TQM) research paper is a valuable endeavor that requires a clear understanding of the subject, strong analytical skills, and a methodical approach to research and writing. This guide outlines how to write an impressive research paper on TQM, including an introductory paragraph, ten actionable tips, and a concluding paragraph.

Total Quality Management is a comprehensive approach that emphasizes continuous improvement, customer satisfaction, employee involvement, and integrated management systems. Writing a research paper on TQM is not just an academic exercise; it is an exploration into the principles and practices that drive quality in organizations. The following detailed guidance aims to equip you with the necessary knowledge and skills to compose a compelling TQM research paper.

  • Understand the Basics of TQM : Start by immersing yourself in the foundational principles of TQM, including its history, methodologies, and various applications across industries. A deep understanding will form the basis of your research.
  • Choose a Specific Topic : As outlined in the previous section, select a specific and relevant topic that aligns with your interest and the current trends in the field of TQM.
  • Conduct Comprehensive Research : Use reputable sources such as academic journals, books, industry reports, and expert opinions to gather information. Always critically evaluate the reliability and relevance of your sources.
  • Create a Thesis Statement : Your thesis statement is the guiding force of your paper. It should be clear, concise, and articulate your main argument or focus.
  • Develop an Outline : Organize your research into a logical structure. An outline will guide you in presenting your ideas coherently and ensuring that you cover all essential points.
  • Write the Introduction : Introduce the topic, provide background information, and present the thesis statement. Make sure to engage the reader and provide a roadmap for the paper.
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A generative AI reset: Rewiring to turn potential into value in 2024

It’s time for a generative AI (gen AI) reset. The initial enthusiasm and flurry of activity in 2023 is giving way to second thoughts and recalibrations as companies realize that capturing gen AI’s enormous potential value is harder than expected .

With 2024 shaping up to be the year for gen AI to prove its value, companies should keep in mind the hard lessons learned with digital and AI transformations: competitive advantage comes from building organizational and technological capabilities to broadly innovate, deploy, and improve solutions at scale—in effect, rewiring the business  for distributed digital and AI innovation.

About QuantumBlack, AI by McKinsey

QuantumBlack, AI by McKinsey, McKinsey’s AI arm, helps companies transform using the power of technology, technical expertise, and industry experts. With thousands of practitioners at QuantumBlack (data engineers, data scientists, product managers, designers, and software engineers) and McKinsey (industry and domain experts), we are working to solve the world’s most important AI challenges. QuantumBlack Labs is our center of technology development and client innovation, which has been driving cutting-edge advancements and developments in AI through locations across the globe.

Companies looking to score early wins with gen AI should move quickly. But those hoping that gen AI offers a shortcut past the tough—and necessary—organizational surgery are likely to meet with disappointing results. Launching pilots is (relatively) easy; getting pilots to scale and create meaningful value is hard because they require a broad set of changes to the way work actually gets done.

Let’s briefly look at what this has meant for one Pacific region telecommunications company. The company hired a chief data and AI officer with a mandate to “enable the organization to create value with data and AI.” The chief data and AI officer worked with the business to develop the strategic vision and implement the road map for the use cases. After a scan of domains (that is, customer journeys or functions) and use case opportunities across the enterprise, leadership prioritized the home-servicing/maintenance domain to pilot and then scale as part of a larger sequencing of initiatives. They targeted, in particular, the development of a gen AI tool to help dispatchers and service operators better predict the types of calls and parts needed when servicing homes.

Leadership put in place cross-functional product teams with shared objectives and incentives to build the gen AI tool. As part of an effort to upskill the entire enterprise to better work with data and gen AI tools, they also set up a data and AI academy, which the dispatchers and service operators enrolled in as part of their training. To provide the technology and data underpinnings for gen AI, the chief data and AI officer also selected a large language model (LLM) and cloud provider that could meet the needs of the domain as well as serve other parts of the enterprise. The chief data and AI officer also oversaw the implementation of a data architecture so that the clean and reliable data (including service histories and inventory databases) needed to build the gen AI tool could be delivered quickly and responsibly.

Our book Rewired: The McKinsey Guide to Outcompeting in the Age of Digital and AI (Wiley, June 2023) provides a detailed manual on the six capabilities needed to deliver the kind of broad change that harnesses digital and AI technology. In this article, we will explore how to extend each of those capabilities to implement a successful gen AI program at scale. While recognizing that these are still early days and that there is much more to learn, our experience has shown that breaking open the gen AI opportunity requires companies to rewire how they work in the following ways.

Figure out where gen AI copilots can give you a real competitive advantage

The broad excitement around gen AI and its relative ease of use has led to a burst of experimentation across organizations. Most of these initiatives, however, won’t generate a competitive advantage. One bank, for example, bought tens of thousands of GitHub Copilot licenses, but since it didn’t have a clear sense of how to work with the technology, progress was slow. Another unfocused effort we often see is when companies move to incorporate gen AI into their customer service capabilities. Customer service is a commodity capability, not part of the core business, for most companies. While gen AI might help with productivity in such cases, it won’t create a competitive advantage.

To create competitive advantage, companies should first understand the difference between being a “taker” (a user of available tools, often via APIs and subscription services), a “shaper” (an integrator of available models with proprietary data), and a “maker” (a builder of LLMs). For now, the maker approach is too expensive for most companies, so the sweet spot for businesses is implementing a taker model for productivity improvements while building shaper applications for competitive advantage.

Much of gen AI’s near-term value is closely tied to its ability to help people do their current jobs better. In this way, gen AI tools act as copilots that work side by side with an employee, creating an initial block of code that a developer can adapt, for example, or drafting a requisition order for a new part that a maintenance worker in the field can review and submit (see sidebar “Copilot examples across three generative AI archetypes”). This means companies should be focusing on where copilot technology can have the biggest impact on their priority programs.

Copilot examples across three generative AI archetypes

  • “Taker” copilots help real estate customers sift through property options and find the most promising one, write code for a developer, and summarize investor transcripts.
  • “Shaper” copilots provide recommendations to sales reps for upselling customers by connecting generative AI tools to customer relationship management systems, financial systems, and customer behavior histories; create virtual assistants to personalize treatments for patients; and recommend solutions for maintenance workers based on historical data.
  • “Maker” copilots are foundation models that lab scientists at pharmaceutical companies can use to find and test new and better drugs more quickly.

Some industrial companies, for example, have identified maintenance as a critical domain for their business. Reviewing maintenance reports and spending time with workers on the front lines can help determine where a gen AI copilot could make a big difference, such as in identifying issues with equipment failures quickly and early on. A gen AI copilot can also help identify root causes of truck breakdowns and recommend resolutions much more quickly than usual, as well as act as an ongoing source for best practices or standard operating procedures.

The challenge with copilots is figuring out how to generate revenue from increased productivity. In the case of customer service centers, for example, companies can stop recruiting new agents and use attrition to potentially achieve real financial gains. Defining the plans for how to generate revenue from the increased productivity up front, therefore, is crucial to capturing the value.

Upskill the talent you have but be clear about the gen-AI-specific skills you need

By now, most companies have a decent understanding of the technical gen AI skills they need, such as model fine-tuning, vector database administration, prompt engineering, and context engineering. In many cases, these are skills that you can train your existing workforce to develop. Those with existing AI and machine learning (ML) capabilities have a strong head start. Data engineers, for example, can learn multimodal processing and vector database management, MLOps (ML operations) engineers can extend their skills to LLMOps (LLM operations), and data scientists can develop prompt engineering, bias detection, and fine-tuning skills.

A sample of new generative AI skills needed

The following are examples of new skills needed for the successful deployment of generative AI tools:

  • data scientist:
  • prompt engineering
  • in-context learning
  • bias detection
  • pattern identification
  • reinforcement learning from human feedback
  • hyperparameter/large language model fine-tuning; transfer learning
  • data engineer:
  • data wrangling and data warehousing
  • data pipeline construction
  • multimodal processing
  • vector database management

The learning process can take two to three months to get to a decent level of competence because of the complexities in learning what various LLMs can and can’t do and how best to use them. The coders need to gain experience building software, testing, and validating answers, for example. It took one financial-services company three months to train its best data scientists to a high level of competence. While courses and documentation are available—many LLM providers have boot camps for developers—we have found that the most effective way to build capabilities at scale is through apprenticeship, training people to then train others, and building communities of practitioners. Rotating experts through teams to train others, scheduling regular sessions for people to share learnings, and hosting biweekly documentation review sessions are practices that have proven successful in building communities of practitioners (see sidebar “A sample of new generative AI skills needed”).

It’s important to bear in mind that successful gen AI skills are about more than coding proficiency. Our experience in developing our own gen AI platform, Lilli , showed us that the best gen AI technical talent has design skills to uncover where to focus solutions, contextual understanding to ensure the most relevant and high-quality answers are generated, collaboration skills to work well with knowledge experts (to test and validate answers and develop an appropriate curation approach), strong forensic skills to figure out causes of breakdowns (is the issue the data, the interpretation of the user’s intent, the quality of metadata on embeddings, or something else?), and anticipation skills to conceive of and plan for possible outcomes and to put the right kind of tracking into their code. A pure coder who doesn’t intrinsically have these skills may not be as useful a team member.

While current upskilling is largely based on a “learn on the job” approach, we see a rapid market emerging for people who have learned these skills over the past year. That skill growth is moving quickly. GitHub reported that developers were working on gen AI projects “in big numbers,” and that 65,000 public gen AI projects were created on its platform in 2023—a jump of almost 250 percent over the previous year. If your company is just starting its gen AI journey, you could consider hiring two or three senior engineers who have built a gen AI shaper product for their companies. This could greatly accelerate your efforts.

Form a centralized team to establish standards that enable responsible scaling

To ensure that all parts of the business can scale gen AI capabilities, centralizing competencies is a natural first move. The critical focus for this central team will be to develop and put in place protocols and standards to support scale, ensuring that teams can access models while also minimizing risk and containing costs. The team’s work could include, for example, procuring models and prescribing ways to access them, developing standards for data readiness, setting up approved prompt libraries, and allocating resources.

While developing Lilli, our team had its mind on scale when it created an open plug-in architecture and setting standards for how APIs should function and be built.  They developed standardized tooling and infrastructure where teams could securely experiment and access a GPT LLM , a gateway with preapproved APIs that teams could access, and a self-serve developer portal. Our goal is that this approach, over time, can help shift “Lilli as a product” (that a handful of teams use to build specific solutions) to “Lilli as a platform” (that teams across the enterprise can access to build other products).

For teams developing gen AI solutions, squad composition will be similar to AI teams but with data engineers and data scientists with gen AI experience and more contributors from risk management, compliance, and legal functions. The general idea of staffing squads with resources that are federated from the different expertise areas will not change, but the skill composition of a gen-AI-intensive squad will.

Set up the technology architecture to scale

Building a gen AI model is often relatively straightforward, but making it fully operational at scale is a different matter entirely. We’ve seen engineers build a basic chatbot in a week, but releasing a stable, accurate, and compliant version that scales can take four months. That’s why, our experience shows, the actual model costs may be less than 10 to 15 percent of the total costs of the solution.

Building for scale doesn’t mean building a new technology architecture. But it does mean focusing on a few core decisions that simplify and speed up processes without breaking the bank. Three such decisions stand out:

  • Focus on reusing your technology. Reusing code can increase the development speed of gen AI use cases by 30 to 50 percent. One good approach is simply creating a source for approved tools, code, and components. A financial-services company, for example, created a library of production-grade tools, which had been approved by both the security and legal teams, and made them available in a library for teams to use. More important is taking the time to identify and build those capabilities that are common across the most priority use cases. The same financial-services company, for example, identified three components that could be reused for more than 100 identified use cases. By building those first, they were able to generate a significant portion of the code base for all the identified use cases—essentially giving every application a big head start.
  • Focus the architecture on enabling efficient connections between gen AI models and internal systems. For gen AI models to work effectively in the shaper archetype, they need access to a business’s data and applications. Advances in integration and orchestration frameworks have significantly reduced the effort required to make those connections. But laying out what those integrations are and how to enable them is critical to ensure these models work efficiently and to avoid the complexity that creates technical debt  (the “tax” a company pays in terms of time and resources needed to redress existing technology issues). Chief information officers and chief technology officers can define reference architectures and integration standards for their organizations. Key elements should include a model hub, which contains trained and approved models that can be provisioned on demand; standard APIs that act as bridges connecting gen AI models to applications or data; and context management and caching, which speed up processing by providing models with relevant information from enterprise data sources.
  • Build up your testing and quality assurance capabilities. Our own experience building Lilli taught us to prioritize testing over development. Our team invested in not only developing testing protocols for each stage of development but also aligning the entire team so that, for example, it was clear who specifically needed to sign off on each stage of the process. This slowed down initial development but sped up the overall delivery pace and quality by cutting back on errors and the time needed to fix mistakes.

Ensure data quality and focus on unstructured data to fuel your models

The ability of a business to generate and scale value from gen AI models will depend on how well it takes advantage of its own data. As with technology, targeted upgrades to existing data architecture  are needed to maximize the future strategic benefits of gen AI:

  • Be targeted in ramping up your data quality and data augmentation efforts. While data quality has always been an important issue, the scale and scope of data that gen AI models can use—especially unstructured data—has made this issue much more consequential. For this reason, it’s critical to get the data foundations right, from clarifying decision rights to defining clear data processes to establishing taxonomies so models can access the data they need. The companies that do this well tie their data quality and augmentation efforts to the specific AI/gen AI application and use case—you don’t need this data foundation to extend to every corner of the enterprise. This could mean, for example, developing a new data repository for all equipment specifications and reported issues to better support maintenance copilot applications.
  • Understand what value is locked into your unstructured data. Most organizations have traditionally focused their data efforts on structured data (values that can be organized in tables, such as prices and features). But the real value from LLMs comes from their ability to work with unstructured data (for example, PowerPoint slides, videos, and text). Companies can map out which unstructured data sources are most valuable and establish metadata tagging standards so models can process the data and teams can find what they need (tagging is particularly important to help companies remove data from models as well, if necessary). Be creative in thinking about data opportunities. Some companies, for example, are interviewing senior employees as they retire and feeding that captured institutional knowledge into an LLM to help improve their copilot performance.
  • Optimize to lower costs at scale. There is often as much as a tenfold difference between what companies pay for data and what they could be paying if they optimized their data infrastructure and underlying costs. This issue often stems from companies scaling their proofs of concept without optimizing their data approach. Two costs generally stand out. One is storage costs arising from companies uploading terabytes of data into the cloud and wanting that data available 24/7. In practice, companies rarely need more than 10 percent of their data to have that level of availability, and accessing the rest over a 24- or 48-hour period is a much cheaper option. The other costs relate to computation with models that require on-call access to thousands of processors to run. This is especially the case when companies are building their own models (the maker archetype) but also when they are using pretrained models and running them with their own data and use cases (the shaper archetype). Companies could take a close look at how they can optimize computation costs on cloud platforms—for instance, putting some models in a queue to run when processors aren’t being used (such as when Americans go to bed and consumption of computing services like Netflix decreases) is a much cheaper option.

Build trust and reusability to drive adoption and scale

Because many people have concerns about gen AI, the bar on explaining how these tools work is much higher than for most solutions. People who use the tools want to know how they work, not just what they do. So it’s important to invest extra time and money to build trust by ensuring model accuracy and making it easy to check answers.

One insurance company, for example, created a gen AI tool to help manage claims. As part of the tool, it listed all the guardrails that had been put in place, and for each answer provided a link to the sentence or page of the relevant policy documents. The company also used an LLM to generate many variations of the same question to ensure answer consistency. These steps, among others, were critical to helping end users build trust in the tool.

Part of the training for maintenance teams using a gen AI tool should be to help them understand the limitations of models and how best to get the right answers. That includes teaching workers strategies to get to the best answer as fast as possible by starting with broad questions then narrowing them down. This provides the model with more context, and it also helps remove any bias of the people who might think they know the answer already. Having model interfaces that look and feel the same as existing tools also helps users feel less pressured to learn something new each time a new application is introduced.

Getting to scale means that businesses will need to stop building one-off solutions that are hard to use for other similar use cases. One global energy and materials company, for example, has established ease of reuse as a key requirement for all gen AI models, and has found in early iterations that 50 to 60 percent of its components can be reused. This means setting standards for developing gen AI assets (for example, prompts and context) that can be easily reused for other cases.

While many of the risk issues relating to gen AI are evolutions of discussions that were already brewing—for instance, data privacy, security, bias risk, job displacement, and intellectual property protection—gen AI has greatly expanded that risk landscape. Just 21 percent of companies reporting AI adoption say they have established policies governing employees’ use of gen AI technologies.

Similarly, a set of tests for AI/gen AI solutions should be established to demonstrate that data privacy, debiasing, and intellectual property protection are respected. Some organizations, in fact, are proposing to release models accompanied with documentation that details their performance characteristics. Documenting your decisions and rationales can be particularly helpful in conversations with regulators.

In some ways, this article is premature—so much is changing that we’ll likely have a profoundly different understanding of gen AI and its capabilities in a year’s time. But the core truths of finding value and driving change will still apply. How well companies have learned those lessons may largely determine how successful they’ll be in capturing that value.

Eric Lamarre

The authors wish to thank Michael Chui, Juan Couto, Ben Ellencweig, Josh Gartner, Bryce Hall, Holger Harreis, Phil Hudelson, Suzana Iacob, Sid Kamath, Neerav Kingsland, Kitti Lakner, Robert Levin, Matej Macak, Lapo Mori, Alex Peluffo, Aldo Rosales, Erik Roth, Abdul Wahab Shaikh, and Stephen Xu for their contributions to this article.

This article was edited by Barr Seitz, an editorial director in the New York office.

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This paper is in the following e-collection/theme issue:

Published on 8.3.2024 in Vol 26 (2024)

The Acceptance and Use of Digital Technologies for Self-Reporting Medication Safety Events After Care Transitions to Home in Patients With Cancer: Survey Study

Authors of this article:

Author Orcid Image

Original Paper

  • Yun Jiang 1, 2 , MSc, PhD   ; 
  • Misun Hwang 1 , MSN   ; 
  • Youmin Cho 1, 3 , PhD, AGPCNP-BC   ; 
  • Christopher R Friese 1, 2, 4 , PhD, AOCN   ; 
  • Sarah T Hawley 2, 4, 5, 6 , MPH, PhD   ; 
  • Milisa Manojlovich 1 , PhD   ; 
  • John C Krauss 2, 5 , MD   ; 
  • Yang Gong 3 , MD, PhD  

1 School of Nursing, University of Michigan, Ann Arbor, MI, United States

2 Rogel Cancer Center, University of Michigan, Ann Arbor, MI, United States

3 McWilliams School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, TX, United States

4 School of Public Health, University of Michigan, Ann Arbor, MI, United States

5 Department of Internal Medicine, University of Michigan, Ann Arbor, MI, United States

6 VA Ann Arbor Center for Clinical Management Research, Ann Arbor, MI, United States

Corresponding Author:

Yun Jiang, MSc, PhD

School of Nursing

University of Michigan

400 North Ingalls Street

Ann Arbor, MI, 48109

United States

Phone: 1 734 763 3705

Email: [email protected]

Background: Actively engaging patients with cancer and their families in monitoring and reporting medication safety events during care transitions is indispensable for achieving optimal patient safety outcomes. However, existing patient self-reporting systems often cannot address patients’ various experiences and concerns regarding medication safety over time. In addition, these systems are usually not designed for patients’ just-in-time reporting. There is a significant knowledge gap in understanding the nature, scope, and causes of medication safety events after patients’ transition back home because of a lack of patient engagement in self-monitoring and reporting of safety events. The challenges for patients with cancer in adopting digital technologies and engaging in self-reporting medication safety events during transitions of care have not been fully understood.

Objective: We aim to assess oncology patients’ perceptions of medication and communication safety during care transitions and their willingness to use digital technologies for self-reporting medication safety events and to identify factors associated with their technology acceptance.

Methods: A cross-sectional survey study was conducted with adult patients with breast, prostate, lung, or colorectal cancer (N=204) who had experienced care transitions from hospitals or clinics to home in the past 1 year. Surveys were conducted via phone, the internet, or email between December 2021 and August 2022. Participants’ perceptions of medication and communication safety and perceived usefulness, ease of use, attitude toward use, and intention to use a technology system to report their medication safety events from home were assessed as outcomes. Potential personal, clinical, and psychosocial factors were analyzed for their associations with participants’ technology acceptance through bivariate correlation analyses and multiple logistic regressions.

Results: Participants reported strong perceptions of medication and communication safety, positively correlated with medication self-management ability and patient activation. Although most participants perceived a medication safety self-reporting system as useful (158/204, 77.5%) and easy to use (157/204, 77%), had a positive attitude toward use (162/204, 79.4%), and were willing to use such a system (129/204, 63.2%), their technology acceptance was associated with their activation levels (odds ratio [OR] 1.83, 95% CI 1.12-2.98), their perceptions of communication safety (OR 1.64, 95% CI 1.08-2.47), and whether they could receive feedback after self-reporting (OR 3.27, 95% CI 1.37-7.78).

Conclusions: In general, oncology patients were willing to use digital technologies to report their medication events after care transitions back home because of their high concerns regarding medication safety. As informed and activated patients are more likely to have the knowledge and capability to initiate and engage in self-reporting, developing a patient-centered reporting system to empower patients and their families and facilitate safety health communications will help oncology patients in addressing their medication safety concerns, meeting their care needs, and holding promise to improve the quality of cancer care.


The rapid growth in cancer treatment options has contributed to improved survival but has increased the complexity of care [ 1 ]. Most adults with cancer now receive their treatments in outpatient settings, and an increasing number of patients take cancer medications orally in their homes [ 2 ]. This shift in cancer care increases the likelihood of transitions across diverse settings, including primary care facilities, cancer centers, community infusion clinics, and homes [ 3 ]. Frequent care transitions may lead to medication safety events owing to inaccurate medication information sharing or poor communication [ 4 ]. Patients often face challenges in managing complex dosage schedules of their cancer medications, potentially life-threatening toxicities, and highly incident drug-drug and drug-food interactions at home [ 5 ]. Furthermore, many patients with cancer take concomitant medications for other chronic conditions [ 6 ]. During care transitions, these medications may be stopped, started, or changed, and unintentional changes at these interfaces can lead to discrepancies, which may, in turn, lead to adverse medication events. Currently, there is a lack of complete understanding of the nature, scope, and causes of medication safety events that patients with cancer experience at home because of a lack of patient engagement in self-reporting safety events from home [ 7 ].

Active engagement of patients with cancer and their families in self-monitoring and reporting adverse medication events from home is indispensable to achieving safe and effective care transitions and optimal patient outcomes [ 8 ]. However, patient and family engagement has been limited, especially in oncology settings [ 9 - 11 ]. There are numerous barriers to such engagement, including knowledge, attitudes and beliefs, health literacy, cultural differences, sex, age, education, economic status, and disease and symptom burdens [ 8 , 12 ]. Moreover, patients may be unable to engage when they receive conflicting recommendations or are excluded from the care-planning process [ 8 ]. As a result, patients may withhold their concerns regarding medication safety, be unwilling or unable to report to clinicians, or even fear reprisals from clinicians [ 7 , 13 ].

A patient-centered medication safety self-reporting system can guide and engage patients with cancer in self-management and reporting their experiences and concerns regarding medication events. The Chronic Care Model (CCM) highlights digital technologies’ support for productive communications between informed, activated patients and a well-prepared, proactive practice team to improve outcomes [ 14 ]. Furthermore, emerging evidence demonstrates the effectiveness of patient-facing technology solutions to empower the patient’s well-being and help strengthen the relationship and communication between patients with cancer and their health care providers [ 15 , 16 ]. However, there are challenges in initiating and engaging people with cancer using technology systems for health self-monitoring and health communications [ 17 - 19 ]. A 2017 pilot study of a web- and telephone-based safety reporting system received only 37 reports in 17 months [ 20 ]. Lessons from this pilot project include increased patient engagement and the focus on high-risk and high-reward populations at risk for notable adverse events [ 20 , 21 ], which are particularly applicable to patients with cancer during care transitions. However, the challenges faced by patients with cancer in adopting digital technologies and engaging in medication safety event self-reporting during transitions of care have not been fully understood.

Existing electronic patient-reported outcome systems for patients with cancer are often limited to reporting preselected common symptoms using survey questionnaires, which are not able to address patients’ various experiences and concerns regarding medication safety during care transitions. In addition, these systems are not designed for patients to initiate timely self-reporting [ 21 - 23 ]. The willingness of oncology patients to use digital technologies to report medication safety events from home settings has been less studied [ 23 , 24 ]. The literature from other clinical settings suggests 3 prerequisites regarding the psychosocial aspects for patient willingness to share safety concerns: cognitive-cultural conditions (eg, patients’ understanding and prioritization of patient safety); structural-procedural conditions (eg, the opportunity, means, and ease of providing feedback); and learning and change conditions (eg, feeling that their feedback would be acted upon and make a difference to patient safety) [ 7 ]. These prerequisite conditions can be further explored among patients with cancer to identify factors associated with their willingness to engage in medication safety event self-reporting after their care transitions to home.

In this survey study, we aimed to assess oncology patients’ perceptions of medication and communication safety during care transitions and their willingness to use digital technologies to self-report medication safety events after care transitions to home and to identify factors associated with their technology acceptance. This study’s findings support subsequent development and testing of personalized technology systems for patients with cancer to self-report medication safety events to improve patient-centered cancer care, especially during care transitions.

Study Design and Participants

A cross-sectional survey study was conducted with patients with cancer who had received care at the University of Michigan Rogel Cancer Center, a National Cancer Institute–designated Comprehensive Cancer Center in the Midwest, from December 10, 2021, to August 30, 2022. This survey study was conducted following the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines [ 25 ] ( Multimedia Appendix 1 ). Eligible participants were screened from electronic health records based on the following inclusion criteria: (1) receiving a diagnosis of invasive colorectal, lung, breast, or prostate cancer; (2) being discharged from the hospital or clinic to a home setting in the past 1 year; and (3) being aged ≥18 years. The 4 cancer types highlight the diversity and representation of participants, and the initial eligibility screening was determined based on the International Classification of Diseases, Tenth Revision codes. Multimedia Appendix 2 lists the corresponding International Classification of Disease, Tenth Revision codes for the 4 types of cancer.

Recruitment and Survey Administration

Figure 1 shows the survey participant recruitment and enrollment process. We recruited participants through convenience sampling. A total of 696 patients were initially identified from the medical record review, of whom 11 (1.6%) were excluded for the following reasons: poor health conditions (4/696, 0.6%), non–English speaker (4/696, 0.6%), or enrolled in an ongoing clinical trial (3/696, 0.4%). An additional 26 (3.7%) patients were excluded at their health care provider’s discretion, resulting in 659 (94.7%) patients who were contacted via either a phone call or an email invitation. Of these 659 patients, 251 (38.1%) expressed their willingness to participate in the survey. Of the 251 participants, 17 (6.8%) withdrew from the study owing to their busy schedules and 30 (11.9%) were lost to follow-up. A total of 204 (81.3%) participants completed the surveys, including 181 (88.7%) participants who submitted using the web-based Qualtrics survey platform, 55 (26.9%) via email, and 9 (4.4%) via phone call.

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Ethical Considerations

This study was determined to be an exempt study by the University of Michigan Institutional Review Board (HUM00203239). Informed consent was obtained from all participants before data collection via phone, email, or the internet. Anonymized survey data were used for analysis. The respondents who completed the survey were given a US $25 gift card to appreciate their time and effort.

The survey included 66 items that were generated by the research team or adapted from the literature. Participants’ acceptance of using digital technologies for self-reporting medication safety events from home as the primary outcome was assessed after a short scenario that described the functionalities of a web-based medication safety event self-reporting system and how it worked. In total, 4 questions were asked about participants’ (1) perceived usefulness (ie, “How likely would you consider this online reporting tool is useful?”), (2) perceived ease of use (“How likely would you consider it is easy to use such an online reporting tool?”), (3) attitudes toward use (“How would you think about reporting your safety experiences or concerns through such an online reporting tool?”), and (4) intention to use this self-reporting system (“Do you intend to use an online reporting tool to report your safety concerns?”), using a 5-point Likert scale, ranging from “very unlikely” to “very likely.” A total of 3 prerequisites, including cognitive-cultural conditions (eg, medication safety perception, perceived safety of communication with physicians, self-rated health, patient activation, and medication self-management ability); structural-procedural conditions (eg, experience with web-based self-reporting systems); and learning and change conditions (eg, perceived importance of feedback and influence of others’ self-reporting responses), were assessed as potential psychosocial factors. Specifically, medication safety perceptions (4 items), perceived safety of communication with a physician (2 items) [ 7 ], self-rated health status (4 items), beliefs about medications (10 items) [ 26 ], patient activation (13 items) [ 27 ], and medication self-management ability (10 items) [ 28 ] were assessed as cognitive-cultural conditions. Prior technology use experiences (6 items), including prior experience with web-based health-related information self-reporting systems (1 item), were assessed as the structural-procedural conditions. Learning and change condition measures included the perceived importance of feedback on their reports (3 items) and the perceived influence of seeing others’ self-reporting responses (1 item). Furthermore, we administered a brief sociodemographic questionnaire (9 items) to collect personal information, such as age, sex, race, ethnicity, income, education, marital status, and employment status. We extracted clinical factors from patients’ electronic medical records, including cancer types and whether they were taking oral anticancer agents (OAAs) and other outpatient medications. The participants were informed that they could decline to answer any question that they preferred not to respond to, and they also had the choice to stop the survey at any point. Refer to Multimedia Appendix 3 for the survey questionnaires.

Statistical Analysis

The characteristics of participants were summarized using descriptive statistics (ie, mean, SD, frequency, and percentage). The associations between each potential factor and participants’ safety perceptions and acceptance of the medication safety self-reporting system were assessed using bivariate correlation analyses. Multiple logistic regression was conducted to identify the adjusted associations between factors and each technology acceptance variable (ie, perceived usefulness, perceived ease of use, attitude toward use, and intention to use, recoded as “likely” vs “unlikely or uncertain”) after controlling for all personal and clinical characteristics and selected psychosocial factors that presented P <.20 in bivariate analyses. Two-sided P values of ≤.05 were considered statistically significant. All statistical analyses were conducted using Stata SE software (version 17.0; StataCorp), and the correlation matrix figure was generated by R software (version 4.2.2; R Foundation for Statistical Computing). A power analysis was conducted to justify a sample size of 204 participants, which was deemed sufficient to identify the estimated squared multiple correlation coefficient of 0.35 through multiple logistic regression using the method introduced by Hsieh et al [ 29 ].

Summary of Sample Characteristics and Covariate Factors

Personal and clinical factors.

Table 1 provides a summary of participants’ personal and clinical characteristics. The mean age of participants was 65.2 (SD 11) years. The sample had a slightly higher number of female participants (108/204, 52.9%), a majority of whom were White participants (179/204, 87.7%), college educated or above (108/204, 52.9%), currently married or living as married (153/204, 75%), and without a full-time or part-time job (150/204, 73.5%). The diagnosis of lung, breast, prostate, and colorectal cancer was approximately equally distributed among the participants. Most participants were taking OAAs currently or previously (140/204, 68.6%) and taking other outpatient medications (146/204, 71.6%) currently.

a Racial and ethnic minority individuals include Black or African American, Asian, or those who identified with >1 race.

b OAA: oral anticancer agent.

Psychosocial Factors

Table 2 provides a summary of participants’ psychosocial factors represented as 3 conditions: cognitive-cultural conditions (eg, medication safety perception, perceived safety of communication with physicians, self-rated health, patient activation, and medication self-management ability); structural-procedural conditions (eg, experience of web-based self-reporting systems); and learning and change conditions (eg, perceived importance of feedback and influence of others’ self-reporting responses).

a Scores range from 1 to 5, with higher scores indicating higher safety perception.

b Scores range from 0 to 12, with higher scores indicating a higher level of medication self-management.

Regarding cognitive-cultural conditions, participants reported strong perceptions of medication safety (mean 4.4, SD 0.48) and perceived safety of communication with a physician (mean 4.5, SD 0.59). More than half of the participants (131/204, 64.2%) reported good or better self-rated health, at least 68.1% (139/204) reported level 3 patient activation (ie, being able to take action to maintain and improve health), and approximately 46.6% (95/204) had adequate medication self-management ability. Regarding structural-procedural conditions, more than one-third of participants (76/204, 37.3%) had prior experience using web-based self-reporting systems. As for learning and change conditions, most participants (161/204, 78.9%) perceived receiving feedback on their self-reporting as very important, and approximately half of the participants (103/204, 50.5%) considered that seeing other people’s self-reporting responses would influence their self-reporting.

Correlations Among Factors

Figure 2 shows the results of bivariate correlation analyses between variables. Specifically, perceived medication safety and perceived safety of communication with a physician were moderately correlated with each other ( r =0.5). Patient activation level ( r =0.43) and medication self-management ability ( r =0.41) were positively correlated with perceived medication safety and perceived safety of communication with a physician ( r =0.33 and r =0.2, respectively).

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Summary of Technology Acceptance

As presented in Table 3 , most participants perceived a medication safety event self-reporting system as useful (158/204, 77.5%) and easy to use (157/204, 77%). The majority (162/204, 79.4%) reported positive attitudes toward use. More than half of the participants (129/204, 63.2%) were willing to use the self-reporting system to report medication safety events or concerns.

Factors Associated With Technology Acceptance

Bivariate analyses indicated that several factors, including perceived safety of communication with a physician, self-rated health, patient activation, and perceived importance of receiving feedback, were significantly correlated with all technology acceptance variables, including perceived usefulness, perceived ease of use, attitude toward use, and intention to use (correlation coefficients ranged from r =0.14 to r =0.39). Medication self-management ability ( r =0.18) and prior experience with web-based self-reporting systems ( r =0.25) were correlated with intention to use only. Medication safety perception and the influence of seeing others’ self-reporting responses were significantly correlated with perceived usefulness, perceived ease of use, and attitude toward use (correlation coefficients ranged from r =0.18 to r =0.26) but not with the intention to use. Among other personal or clinical factors, age was negatively associated with perceived usefulness and ease of use ( r =−0.15 and r =−0.24, respectively), and taking other outpatient medications was associated with a positive attitude toward use ( r =0.22). All technology acceptance and intention to use variables were strongly correlated with each other, with coefficients ranging from r =0.57 to r =0.71 ( Figure 2 ).

Perceived Usefulness

Logistic regression modeling indicated that the perceived safety of communication with a physician (odds ratio [OR] 3.59, 95% CI 1.52-8.48), the importance of receiving their self-reporting feedback (OR 2.59, 95% CI 1.03-6.51), and the influence of viewing others’ self-reporting responses (OR 2.53, 95% CI 1.08-5.91) were independent predictors of the perceived usefulness of the web-based self-reporting system, after controlling for other variables in the model. In addition, the odds of perceived usefulness were 73% lower among participants who were married or those who were living as married (OR 0.27, 95% CI 0.09-0.81), higher among those with a college graduate or postgraduate educational background (OR 2.55, 95% CI 1.06-6.12), and higher among those with a full-time or part-time occupation (OR 6.64, 95% CI 1.65-26.79). Participants’ clinical factors were not associated with the perceived usefulness of the web-based self-reporting system ( Table 3 ).

Perceived Ease of Use

Logistic regression modeling indicated that the perceived medication safety (OR 3.37, 95% CI 1.07-10.58) and safety of communication with a physician (OR 2.44, 95% CI 1.05-5.68) were independent predictors of perceived ease of use of the web-based self-reporting system, after controlling for other variables in the model. In addition, the odds of perceived ease of use were 4 times higher among patients with a full-time or part-time occupation than among those without an occupation (OR 4, 95% CI 1.05-15.17). The participants’ clinical factors were not associated with the perceived ease of use of the web-based self-reporting system ( Table 3 ).

Attitude Toward Use

Logistic regression modeling indicated that the perceived safety of communication with a physician (OR 9.06, 95% CI 2.95-27.84), the importance of receiving their self-reporting feedback (OR 2.99, 95% CI 1.11-8.05), and the influence of viewing others’ self-reporting responses (OR 3.36, 95% CI 1.3-8.68) were independent predictors of attitude toward use, after controlling for other variables in the model. In addition, the odds of having a positive attitude toward use were 4.23 times higher among patients taking outpatient medications (OR 4.23, 95% CI 1.63-10.99). Participants’ personal factors were not associated with attitude toward use ( Table 3 ).

Intention to Use

Logistic regression modeling indicated that the perceived safety of communication with a physician (OR 2.68; 95% CI 1.17-6.11), patient activation (OR 1.83, 95% CI 1.12-2.98), previous experience with the web-based self-reporting system (OR 3.8, 95% CI 1.73-8.36), and perceived importance of receiving their self-reporting feedback (OR 3.27, 95% CI 1.37-7.78) were independent predictors of intention to use the web-based self-reporting system, after controlling for other variables in the model. In addition, the odds of intention to use were 3.4 times higher among patients with a full-time or part-time occupation than among those without an occupation (OR 3.4, 95% CI 1.26-9.19). Participants’ clinical factors were not associated with intention to use the web-based self-reporting system ( Table 4 ).

a OR: odds ratio.

b Italicized values denote the statistical significance of the P value ( P <.05).

c OAA: oral anticancer agent.

Principal Findings

This study demonstrated that patients with cancer had strong perceptions of medication and communication safety during transitions of care and a relatively high acceptance of digital technologies for self-reporting medication safety events after transitions back home. Furthermore, we identified significant factors associated with their technology acceptance, including patient activation, medication self-management ability, perceived medication and communication safety, perceived influence of seeing others’ self-reporting responses, and perceived importance of receiving feedback. Patients with cancer often experience transitions between different care settings, which place them at risk for adverse medication events [ 3 , 4 ]. A patient-oriented medication safety self-reporting system has the potential to engage patients and their families in self-reporting safety events from home settings, which can consequently enhance the understanding of the nature, scope, and causes of medication safety events occurring after patients transition back home and improve patient-centered cancer care [ 7 , 30 - 32 ]. The findings of this study increased the understanding of oncology patients’ willingness to adopt such a self-reporting system. This will contribute to the development of patient-facing technology systems tailored for self-reporting medication safety events. The associations between the factors, such as the perceived importance of feedback and the influence of others’ self-reporting responses, and technology acceptance (perceived usefulness, perceived ease of use, attitude toward use, and intention to use) could be further translated into system functionality and data representation, which are essential tasks for engaging patients.

As indicated in this study, oncology patients had a strong sense of medication safety and communication safety with their providers. These factors were positively associated with their activation level, ability to self-manage their medications, and acceptance of technology for self-reporting medication safety events, particularly their intention to use the self-reporting system. Patients’ concerns regarding their medication and communication safety were demonstrated to motivate their initiation and engagement in self-reporting medication safety events and their adoption of digital technology to improve medication safety. These findings are also perfectly aligned with the CCM, which emphasizes the effective interactions between patients who have been informed and activated and health care teams that are well-prepared and proactive, thus contributing to high-quality care outcomes [ 14 , 33 ]. Patient activation is not a new concept in oncology care settings. It has been reported to correlate with patients’ confidence in managing their OAA side effects and subsequent adherence [ 34 ]. Interpreted by cognitive-cultural conditions for patient willingness to share safety concerns, patients and families who are well equipped with adequate patient activation and abilities for medication self-management can understand and prioritize medication safety events and actively engage in self-reporting of medication safety events after they transition back home [ 7 , 35 , 36 ]. As an independent predictor of patients’ intention to use the self-reporting system, patient activation reflects their readiness and ability to be involved in their medication self-management. Therefore, to facilitate patient initiation and long-term engagement in using the medication safety event self-reporting system, the assessment and promotion of patient activation can be a fundamental design in developing the self-reporting system. It has been demonstrated that improving patient activation is feasible through continuous patient education, increased understanding of patient needs and expectations, and provision of personalized feedback and self-management recommendations [ 37 , 38 ]. In addition, digital technology as a tool, if designed and used appropriately, can significantly improve patients’ knowledge, skills, and confidence in self-management [ 36 ]. Therefore, a well-designed and developed patient-centered medication safety self-reporting system should be able to positively affect patient activation by providing accessible and useful medication information to support patient needs [ 39 ].

It is not surprising that prior technology use experience was a predictor of patients’ technology acceptance for self-reporting medication safety events, as theoretically, this factor is indicated in the Unified Technology Acceptance and Use Theory (UTAUT) [ 40 ]. Furthermore, it is understandable that patients’ perceptions of communication safety with health care providers can facilitate their intention to use the safety self-reporting system, which aligns with the interpersonal process of care and communication [ 41 , 42 ]. One notable finding was the association between patients’ perceptions of the importance of receiving their self-reporting feedback and their acceptance of the medication safety self-reporting system. Patients who preferred to receive feedback on their self-reporting were more likely to perceive the usefulness of the self-reporting system, have a positive attitude toward it, and have the intention to use it. This finding may confirm the prerequisite learning and change conditions from the literature, suggesting that a closed feedback loop between patients and clinicians is needed to improve patient safety [ 7 , 35 , 43 ]. Moreover, when patients and families serve as vigilant partners in medication safety self-monitoring and report their experiences and concerns after their care transitions back home, they can make a significant contribution to the understanding of the nature, scope, and causes of patient safety events outside health care systems that have been underreported historically [ 7 , 44 , 45 ].

To facilitate informed decision-making in cancer care, the medication safety self-reporting system should consider patient needs to enhance patient safety, promote self-management, and improve patient-centered care [ 46 ]. Patient-facing technologies, such as mobile health (mHealth) and wearable devices, are able to satisfy these expectations to increase the patient’s access to health information, support engagement in self-management, and improve communication with health care providers [ 47 ]. From the perspective of structural-procedural conditions for patient willingness to share safety concerns, patient-facing technologies are capable of generating personalized feedback based on the patient’s self-reporting and support interactive information exchanges to make the step-by-step process of self-reporting easy to follow, with downstream opportunities to increase patient engagement in the use of the system, improve patient outcomes, and reduce the cost of care in the long run [ 7 , 35 , 48 , 49 ]. Certainly, it is important to design these technologies to be user-friendly, secure, and accessible to all patients, especially to those who are at high risk of adverse medication events and in high need of self-management support, that is, patients who take OAAs and experience care transitions back home, being expected to manage their cancer treatments by themselves at home [ 50 - 53 ]. As reported by Beauchemin et al [ 53 ], the OAA adherence rates among these patients are suboptimal, ranging from 14% to 100%, depending on the agents and measures. Suboptimal OAA adherence can lead to poor survival, severe toxicities, and increased use of health care resources [ 54 - 56 ]. This study solicited perceptions, willingness, and acceptance of technologies to support the subsequent development of effective programs for patient-centered and evidence-based cancer care.

Comparison With Prior Work

Constructs from the CCM, Technology Acceptance Model (TAM), and UTAUT were adopted in this study to help understand oncology patients’ acceptance and use of digital technologies for self-reporting medication safety events after their care transitions back home [ 14 , 40 ]. Previous studies have explored the acceptance and use of mHealth or eHealth apps for self-management among the survivors of cancer and revealed whether personal factors, such as age, education, marital status, and employment status, and clinical factors, such as cancer diagnosis timeframe and that survivors are undergoing active treatment, mattered or not [ 22 ]. Consistently, this study suggested similar personal factors, including education, marital status, and employment status, for technology acceptance. However, since the previous study by de Brun et al [ 13 ] focused on general patient self-management instead of the self-reporting of medication safety events specifically, it was not able to address one of the main constructs of the CCM, which is a facilitator of involving the informed and activated persons in the process of productive interactions with health care teams, as indicated in this study [ 14 ]. Another study by Jiang et al [ 22 ] was a systematic review of the acceptance and use of home-based electronic symptom self-reporting systems by patients with cancer. This review is also guided by the CCM and UTAUT and has suggested that the interactive system features can improve patients’ engagement in self-reporting, which is congruent with this study [ 23 ]. Furthermore, this review criticizes that existing home-based symptom self-reporting systems lack personalization features and only use questionnaires to collect patients’ self-reporting data, which could not meet patients’ various needs for self-reporting their safety concerns more conveniently and flexibly at any time [ 23 ]. This study had a similar finding, highlighting the patients’ strong concerns regarding medication safety. It indicated that patients with cancer want to receive feedback on what they have reported at a personalized level. Although the TAM and UTAUT has been widely used to identify factors associated with technology system acceptance and use, its implications for the medical domain have been frequently criticized for lacking consideration of the complex health care context and need to be reassessed for additional and external factors that match with the targeted health context [ 57 , 58 ]. The implication of TAM and UTAUT in the context of self-reporting medication safety events in patients with cancer has not been reported before. Self-reporting of medication safety events includes but is not limited to self-reporting of symptoms (or adverse effects), medication nonadherence, medication self-administration errors, drug-drug or drug-food interactions, and safe handling or storage of OAAs. Overall, no previous study has targeted technology acceptance for self-reporting of medication safety events after oncology patients’ care transitions back home [ 59 ].


This study had several limitations. First, with a cross-sectional design, the study could not follow up with patients to understand the changes in their perception over time. It also could not demonstrate the causal relationships between the identified factors and technology acceptance (perceived usefulness, perceived ease of use, attitude toward use, and intention to use). However, the sample size of 204 participants had adequate power to reveal the potential associations among them. Furthermore, theoretical frameworks, such as the CCM, TAM, and UTAUT, were used to guide the identification and interpretation of potential factors. Second, the study was conducted at a single site, which had the potential limitation of reaching a homogenous group. Therefore, the findings may not be generalizable to other settings or regions. Third, no existing medication safety self-reporting system can be provided to assess patients’ actual technology use experience. Although a scenario that describes the possible system was demonstrated in the survey, some participants may have had difficulty envisioning a pseudosystem unless they have actually used it. Therefore, longitudinal studies are needed to explore patients’ acceptance and actual use of digital technologies for self-reporting medication safety events to completely understand patients’ long-term engagement behaviors.


This study provides new insights into oncology patients’ perceptions of safety during care transitions and their willingness to use digital technologies to self-report medication safety events after care transitions back home. Specifically, it highlights the importance of improving patient activation and medication self-management abilities to potentially increase their understanding and capabilities to prioritize medication safety events and engage them in using digital technology for self-reporting medication safety events. In addition, improving patients’ technology use experience through appropriate training programs; assessing patients’ perceptions of safety communication with health care providers; and integrating personalized features in the system design, such as providing individualized feedback on patient self-reporting, should be able to facilitate technology acceptance for self-reporting medication safety events in patients with cancer. As the informed and activated patients are more likely to have the knowledge and capability to initiate and engage in self-reporting, developing a patient-centered reporting system to empower patients and their families and facilitate safety health communications will help oncology patients in addressing their medication safety concerns, meeting their care needs, and holding promise to improve the quality of cancer care.


This study was funded by the Agency for Healthcare Research and Quality (YJ and YG: R01HS027846) and supported by the National Cancer Institute (CRF: P30-CA-046592; T32-CA236621) and the UTHealth Houston, Cancer Prevention and Research Institute of Texas Innovation for Cancer Prevention Research Postdoctoral Fellowship (YC: RP210042). The views expressed herein are solely those of the authors and do not necessarily reflect the views of the Agency for Healthcare Research and Quality, the National Cancer Institute, or the Cancer Prevention and Research Institute of Texas.

Data Availability

The data supporting the findings of this study are available from the corresponding author upon reasonable request.

Authors' Contributions

YJ and YG proposed the research questions and design. YJ and YC were responsible for participant selection and data acquisition. MH and YC conducted data cleaning and statistical analyses. YJ, YG, MH, and YC were involved in data interpretation and manuscript writing. CRF, STH, MM, and JCK were involved in manuscript editing and proofreading. All authors approved the final submitted version and agreed to be accountable for all aspects of this work.

Conflicts of Interest

CRF is on the Board of Governors of the Patient-Centered Outcomes Research Institute, is a member of the National Cancer Advisory Board, and receives institutional research funding from the National Cancer Institute and the NCCN Foundation or Pfizer (none of these roles are related to this manuscript). YJ is the co-editor-in-chief of JMIR Aging. All other authors declare no other conflicts of interest.

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines.

International Classification of Diseases, Tenth Revision codes for the 4 eligible cancer types.

Survey questionnaires.

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Edited by A Mavragani; submitted 29.03.23; peer-reviewed by J Kabukye, Y Chu; comments to author 14.08.23; revised version received 18.09.23; accepted 09.02.24; published 08.03.24.

©Yun Jiang, Misun Hwang, Youmin Cho, Christopher R Friese, Sarah T Hawley, Milisa Manojlovich, John C Krauss, Yang Gong. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 08.03.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

An Update of Pharmacological Management in Children with Functional Constipation

  • Review Article
  • Open access
  • Published: 20 March 2023
  • Volume 25 , pages 343–358, ( 2023 )

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  • Anna de Geus   ORCID: orcid.org/0000-0002-2282-0128 1 ,
  • Ilan J. N. Koppen 1 ,
  • Robert B. Flint 2 , 3 ,
  • Marc A. Benninga 1 &
  • Merit M. Tabbers 1  

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Functional constipation is a common problem in childhood worldwide and has a great impact on social, physical, and emotional functioning of affected children and their caregivers. It is a clinical diagnosis based on the Rome IV criteria. Non-pharmacological treatment involves education, demystification, lifestyle advice, and toilet training. Pharmacological treatment consists of disimpaction, maintenance treatment, and eventually weaning if possible. Polyethylene glycol is considered as the first choice of laxative for both disimpaction and maintenance treatment. Different osmotic laxatives, stimulant laxatives, lubricants, and enemas are available as alternative pharmacological treatment options. Novel drugs are emerging but evidence to support the widespread application of these drugs in the pediatric population is often lacking and more high-quality research is needed in this field. If children remain symptomatic despite optimal pharmacological treatment, botulinum toxin injections in the anal sphincter can be considered as an alternative, more invasive treatment option. This review provides an update on currently available literature concerning the pharmacologic treatment of functional constipation in children.

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Management of functional constipation in children: therapy in practice.

Ilan J. N. Koppen, Laureen A. Lammers, … Merit M. Tabbers

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Treat functional constipation in children with conventional options first and consider alternatives if needed

research paper on quality management

Functional Constipation in Children

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1 Introduction

Functional constipation (FC) is a common problem in childhood, with a worldwide pooled prevalence of 9.5% [ 1 ]. Functional constipation is a clinical diagnosis based on the Rome IV criteria (Table 1 ) [ 2 ]. Children with FC usually present with infrequent painful defecation often accompanied by fecal incontinence and abdominal pain [ 3 ]. These symptoms greatly impact social, physical, and emotional functioning of affected children and their caregivers [ 4 , 5 ]. According to the international guideline from the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN), the first step in the treatment of FC consists of education, demystification, and lifestyle advice [ 6 ]. Toilet training with a reward system is added if the child has a developmental age of at least 4 years [ 6 ]. If symptoms persist despite non-pharmacological interventions, osmotic laxatives are added to the treatment. Despite medical interventions, a large proportion of patients remain symptomatic. In secondary and tertiary care settings, 40% of treated children have been reported to remain symptomatic after 6–12 months [ 7 ]. Furthermore, laxatives may have several side effects, such as fecal incontinence, flatulence, abdominal pain, and nausea [ 8 ]. Therefore, new pharmacologic options keep emerging and their efficacy and safety are continuously investigated. Here, we provide an updated review on the currently available literature regarding the pharmacologic treatment of FC in children. Aspects related to the evaluation and non-pharmacological treatment of FC are discussed briefly.

1.1 Definition

The pediatric Rome criteria were first developed in 1999 and enable the diagnosing of functional gastrointestinal disorders according to symptom-based definitions. Since then, the Rome criteria have been revised several times and the last revision resulted in the current pediatric Rome IV criteria, which were published in 2016 (Table 1 ) [ 2 ]. According to the ESPGHAN/NASPGHAN guideline, intractable constipation is defined as constipation not responding to optimal conventional treatment for at least 3 months [ 6 ].

1.2 Pathophysiology

Possible organic causes of constipation include metabolic or endocrine conditions, anatomical anorectal abnormalities, and neuromuscular conditions such as Hirschsprung’s disease or spina bifida [ 9 ]. However, in approximately 95% of all children with constipation, no organic cause can be found and these children are considered to have FC [ 10 ].

The pathophysiology of FC is considered to be multifactorial. In young children, withholding behavior is one of the major contributing factors for developing constipation [ 11 ]. This behavior is often initiated after a child has experienced painful defecation due to hard stools [ 12 ]. Withholding stools and postponing defecation results in prolonged periods of absorption of water in the colon and rectum. This leads to dry and hard stools that are more difficult to pass and cause pain during defecation, which further stimulates withholding behavior [ 13 ]. This often chronic behavior can eventually result in fecal impaction. Fecal impaction is defined as an excessive amount of hard stool in the rectum [ 6 ]. Fecal impaction often causes overflow fecal incontinence, which is caused by soft feces that pass the fecal obstruction in the rectum [ 8 ]. After prolonged periods of withholding and recurring fecal impaction, the rectal compliance increases and larger volumes of stool are necessary to generate an urge for defecation, leading to an increase of stool retention [ 13 ].

Psychological factors and behavioral disorders, such as autism spectrum disorders and attention-deficit/hyperactivity disorder, may also play a role in the pathophysiology of FC [ 14 , 15 , 16 ]. Psychological factors include stress, adverse life events, bullying, and anxiety [ 17 , 18 ]. Other factors that have been suggested to play a role in the development of FC are socioeconomic status, specific parental child-rearing attitudes, genetics, lifestyle, diet, the gut microbiome, and colonic dysmotility [ 19 , 20 , 21 ].

2 Evaluation

A thorough clinical evaluation is the most important part in the diagnostic process of FC in children. An extensive clinical history and physical examination can be sufficient to establish the diagnosis if patients meet the diagnostic Rome IV criteria and if symptoms cannot be attributed to an underlying organic cause [ 2 ]. Healthcare professionals should always be cautious of alarm signs for underlying organic causes or signs of physical or sexual abuse [ 6 ].

Additional diagnostic testing has a limited role in the evaluation of FC, but may include investigations such as laboratory testing, abdominal radiography, colonic transit time measurement, transabdominal rectal ultrasonography, and anorectal manometry. These additional tests are only indicated when an organic cause is suspected or if children do not respond to treatment, and should not be part of the routine work-up of constipation [ 6 ].

3 Non-Pharmacological Treatment

Non-pharmacological treatment is the first step in management of FC. The ESPGHAN/NASPGHAN guideline recommends a normal fiber and fluid intake and normal physical activity in combination with education and demystification. Toilet training is added to the treatment for children with a developmental age of at least 4 years [ 6 , 22 ]. Both patients and parents should be educated about the pathophysiology of FC and the accompanying fecal incontinence.

Several additional non-pharmacological treatment options are available. A recent systematic review and meta-analysis evaluated the available evidence and showed that abdominal electrical stimulation, Cassia Fistula emulsion, and cow’s milk exclusion diet may be effective for increasing defecation frequency [ 23 ]. Other non-pharmacological treatment options such as prebiotics and probiotics, synbiotics, biofeedback, massage therapy, and alternative medicine have not shown to significantly improve defecation frequency [ 23 ].

4 Phases of Pharmacological Treatment

Pharmacological treatment is the next step in the management of FC, when education, demystification, lifestyle and diet advice, and toilet training are not sufficient. Pharmacological treatment consists of three phases: disimpaction, maintenance treatment, and finally, weaning if possible.

4.1 Disimpaction

Fecal disimpaction is the first step in pharmacological treatment and is indicated when a hard fecal mass is identified in the rectum. Disimpaction also improves the response to maintenance treatment [ 24 ]. A randomized controlled trial among 90 children with FC compared the effect of high-dose (1–1.5 g/kg/day) oral polyethylene glycol (PEG) and sodium docusate enema for 6 consecutive days on disimpaction, and showed no difference in efficacy between both treatments [ 25 ]. High-dose PEG, however, is associated with a higher frequency of fecal incontinence during this treatment phase [ 25 ]. Because treatment with rectal enemas is considered to be more invasive than oral PEG, the ESPGHAN/NASPGHAN guideline recommends the use of PEG as a first choice for disimpaction and enemas can be prescribed when PEG is not available [ 6 ]. Other oral pharmacological options can be considered for disimpaction if high-dose oral PEG and enemas are not tolerated or ineffective (e.g., lactulose, magnesium citrate, sodium picosulfate). However, evidence regarding the effectiveness and well-established dosages for disimpaction are often lacking for these alternative treatments. For these drugs, studies on disimpaction are discussed in the sections below if evidence is available.

4.2 Maintenance

After successful disimpaction, it is necessary to continue with maintenance treatment. The ESPGHAN/NASPGHAN guideline recommends the use of PEG as a first choice for maintenance treatment, based on the effectiveness concerning defecation frequency when compared with the other laxatives [ 6 , 26 ]. If PEG is not available, lactulose is recommended as an alternative osmotic laxative. In addition to these two osmotic laxatives, other laxatives are available and are discussed below. No randomized controlled trials (RCTs) have evaluated the optimal duration for maintenance treatment. The recommendations in the ESPGHAN/NASPGHAN guideline state that after 2 weeks of treatment, the effect should be assessed in order to intensify treatment if necessary. Furthermore, treatment should be continued for at least 2 months [ 6 , 8 ]. Children who are in the process of being toilet trained should continue medication until toilet training is accomplished [ 27 ].

Table 2 displays the dosage advice per laxative, based on the ESPGHAN/NASPGHAN guideline and the international clinical resource website: UpToDate . It is important to note that advised dosages can change over time and may vary between different guidelines, care centers, and countries.

4.3 Weaning

After a child has been treated for at least 2 months, weaning can be initiated when symptoms are sufficiently reduced or absent for at least 1 month [ 6 ]. This means that the child has a defecation frequency of at least three times per week and does not meet the Rome IV criteria for FC anymore. Dosages and dosing frequency should be reduced gradually, in order to prevent relapses [ 6 ]. It is important to carefully warn caregivers and children about the risk of relapses.

5 Osmotic Laxatives

Osmotic laxatives are the first-choice medication for maintenance treatment. Osmotic laxatives are poorly absorbed in the gut, which causes an increase in osmolarity, resulting in the influx of water into the intestinal lumen. The increased amount of water results in the softening and loosening of stools [ 28 ]. Additionally, an increase of the intestinal stool volume leads to distention of the lumen, which stimulates peristalsis and helps with the passing of stools [ 28 ].

5.1 Polyethylene Glycol

Polyethylene glycol is the first-choice laxative for both disimpaction and maintenance treatment. Polyethylene glycol can be administered orally with or without addition of electrolytes. A recent meta-analysis reported that, for maintenance treatment of FC in children aged 6 months or older, PEG with and without electrolytes are equally effective and both are well tolerated [ 29 ]. However, the addition of electrolytes deteriorates the palatability of PEG, and in some children this may negatively affect treatment adherence [ 29 ]. A retrospective study in 51 children with FC and fecal impaction also showed no difference in efficacy between PEG with or without electrolytes for disimpaction [ 30 ]. However, in contrast to the recent meta-analysis, significantly more adverse events occurred in children receiving PEG with electrolytes compared with PEG without electrolytes; 48% ( n = 11/23) versus 4% ( n = 1/28). Adverse events included electrolyte abnormalities, abdominal pain, and nausea and vomiting [ 30 ].

Two types of PEG are available: PEG 3350 and PEG 4000. The numbers represent the molecular weight of the molecules at 3.350 and 4.000 g/mol, respectively. Similar efficacy and safety for long-term use of PEG 3350 with electrolytes compared to PEG 4000 without electrolytes in children aged from 6 months to 16 years were reported in a randomized double-blind multicenter study [ 31 ].

The use of PEG has been studied intensively over the last decades. In 2016, a Cochrane meta-analysis included studies that compared PEG with placebo, showing a higher frequency of stools per week in children treated with PEG [ 26 ]. Several RCTs have compared the efficacy of PEG and lactulose and the same Cochrane meta-analysis reported a significantly higher defecation frequency for PEG [ 26 , 32 , 33 ]. However, these results should be interpreted with caution because of the low quality of the included studies. In addition, the clinical relevance of this difference in defecation frequency is debatable because the mean difference was 0.7 stools per week [ 26 ]. The Cochrane meta-analysis also included three studies comparing PEG to magnesium hydroxide, and showed a significantly higher number of defecations in favor of PEG, although the difference was small [ 26 ].

The advised dosage for PEG maintenance treatment in children of all ages with FC is 0.2–0.8 g/kg/day, with a starting dose of 0.4 g/kg/day. It can be administered once daily or divided in several doses. Dosages and dosing frequency should be individualized to obtain optimal treatment success. For fecal impaction a dosage of 1–1.5 g/kg/day is advised, with a maximum of 6 consecutive days [ 6 ]. A recent systematic review including five studies investigated the optimal dose for children aged younger than 2 years with FC [ 34 ]. Children included in these studies were aged 0–24 months, with most children aged 6 months or older. Because of the limited number of included studies and variability in outcome measures for dosages (e.g., mean daily dose, mean initial dose, and median daily effective dose), no definite conclusions could be made regarding the optimal dosage. However, the authors suggest a conservative initial dose to minimize side effects and adjust the dose based on clinical response [ 34 ].

Side effects of PEG are generally minor and include flatulence, abdominal pain, nausea, and abdominal bloating [ 8 ]. Recent studies regarding the safety of PEG have specifically focused on administration in children under the age of 2 years, reporting only minor side effects for these young pediatric patients [ 34 , 35 ]. In patients with water and electrolyte balance disturbances (e.g., reduced hepatic or renal functioning, or patients taking diuretics), monitoring of serum electrolytes should be performed and PEG should be prescribed with caution [ 36 ].

In recent years, the US Food and Drug Administration has received several reports of neuropsychiatric events in children taking PEG 3350, including tremors, tics, and obsessive compulsive behavior [ 37 ]. However, to date, evidence on any relationship between PEG and neuropsychiatric events remains limited to anecdotal reports [ 36 ]. In addition, several studies have demonstrated that the administration of PEG does not lead to elevated blood levels of neurotoxins in children and does not lead to anxiety-like behavior in mice [ 38 , 39 , 40 ]. The Food and Drug Administration is currently still investigating the long-term safety of PEG in children, but has stated that no changes in current policy are necessary.

5.2 Lactulose and Lactitol

Lactulose and lactitol are synthetic disaccharides of lactose, which are fermented into low-molecular-weight acids in the colon by bacterial enzymes. These acids cause an osmotic effect, resulting in an increase of intraluminal fluids. In addition, the acids result in a lower fecal pH, which stimulates colonic peristalsis [ 28 ]. If PEG is not available, lactulose is the second choice of medication for maintenance treatment in children with FC. A Cochrane review included 11 studies investigating lactulose and concluded that lactulose is a safe and effective laxative in children aged from 6 months to 16 years [ 26 ]. Adverse events are usually minimal and include abdominal gas, bloating, and cramping [ 21 ].

As previously mentioned, evidence has shown that PEG is more effective for the treatment of FC in children than lactulose; however, the difference in defecation frequency is minor (mean difference of 0.7) [ 26 , 32 , 33 ]. The same Cochrane review also compared the efficacy of lactulose with mineral oil (liquid paraffin) and magnesium hydroxide (milk of magnesia), and showed a statistically significant difference in defecation frequency favoring mineral oil and magnesium hydroxide. Mean differences were 1.5 and 4.9 stools per week, respectively [ 26 ]. Lactulose also showed no statistically significant differences in defecation frequency compared to lactitol and senna [ 26 ]. Lactulose is recommended for maintenance treatment if PEG is not available, as there is more evidence available on the efficacy of lactulose than of mineral oil and magnesium hydroxide and because lactulose is safe for all ages [ 6 ].

In a recent open-label randomized study, the use of high-dose lactulose (4–6 mL/kg/day) for fecal impaction as an alternative for to PEG was investigated and promising results were reported [ 41 ]. The PEG group showed a faster disimpaction response, but there was no significant difference in achieving disimpaction after the sixth day of treatment. More research is necessary, but these results show that lactulose could perhaps be a good alternative to PEG for fecal impaction if PEG is not available [ 41 ].

Lactitol is a lactulose-like derivative with an osmotic effect and it also functions as a lactulose-derived prebiotic. Lactitol showed no significant differences for defecation frequency when compared with lactulose [ 26 ]. A study in adults explored the beneficial effects of lactitol on gut microbial composition and the association with the alleviation of constipation symptoms in 29 patients [ 42 ]. The levels of Bifidobacterium in the feces increased after administration of lactitol, and this correlated with an improvement of constipation symptoms [ 42 ]. These positive results should be interpreted with caution because of the small sample size of the study.

5.3 Magnesium Hydroxide

Magnesium hydroxide (also known as milk of magnesia) and other magnesium salts, such as magnesium sulfate and magnesium citrate, are poorly absorbed particles. The laxative effect is derived from these hyperosmolar agents causing an osmotic gradient [ 28 ].

A meta-analysis included three studies comparing PEG with magnesium hydroxide with a follow-up of 4 weeks, and showed a statistically significant higher defecation frequency for PEG (mean difference of 0.69 stools per week) [ 26 ]. In contrast to these findings, a recent open-label randomized controlled trial with a follow-up of 12 months reported no difference in treatment success and adverse events between the two laxatives [ 43 ]. Treatment success was defined as three bowel movements per week without episodes of fecal incontinence, fecal impaction, or abdominal pain, and no need for another laxative. An additional interesting finding from this study was that magnesium hydroxide was significantly less well tolerated compared with PEG by children aged older than 4 years. A higher number of patients rejected magnesium hydroxide in this group, which could be related to the poor palatability of magnesium hydroxide [ 43 ]. The hypothesis that magnesium could positively affect defecation patterns in children is supported by a recent open-label comparator-controlled study evaluating the effect of magnesium-rich formula in 286 infants aged younger than 6 months. Infants receiving magnesium-rich formula were reported to have a significantly softer stool consistency and a significantly higher defecation frequency compared with infants receiving regular formula [ 44 ].

Side effects of magnesium hydroxide include diarrhea, abdominal pain, and bloating. Magnesium hydroxide should be used with caution in children with renal insufficiency, owing to the increased chance of hypermagnesemia [ 28 ].

Oral magnesium citrate is predominantly used for bowel cleansing prior to colonoscopy in children and little evidence is available for the use in the treatment of FC in children. A retrospective study investigated the use of magnesium citrate for disimpaction in children with constipation compared to PEG via a nasogastric tube and reported similar numbers of successful disimpaction, 90% and 85% respectively [ 45 ]. However, 12% of the children were unable to drink the entire dose of magnesium citrate. In this study, the success of disimpaction was assessed on an abdominal radiograph and the dosage of magnesium citrate consisted of one ounce/year of age and was repeated in 3 hours if food-coloring hue liquid stools did not pass [ 45 ].

6 Stimulant Laxatives

Stimulant laxatives can be applied as an additional or second-line treatment of FC in children when osmotic laxatives alone are not sufficient. Stimulant laxatives enhance colonic peristalsis and secretion by stimulation of the enteric nervous system [ 28 ]. Stimulant laxatives can be subdivided into diphenylmethanes (e.g., bisacodyl and sodium picosulfate) and anthraquinones (e.g., senna). These drugs are often prescribed as additional treatment and are considered to be safe and effective even though there is a shortage of well-designed trials in children [ 8 ]. Stimulant laxatives are generally well tolerated, despite the fact that abdominal pain is a common side effect [ 28 ].

6.1 Diphenylmethanes

Bisacodyl and sodium picosulfate belong to the group of diphenylmethanes. Diphenylmethanes are hydrolyzed by colonic bacteria or brush border enzymes into their active metabolites, which promote colonic peristalsis and secretion [ 28 ]. Bisacodyl can be administered orally or rectally. Oral administration starts with 5 mg once daily for children aged three years or older, and rectal administration starts with 5 mg per day for children aged 2 years or older [ 6 ]. Rectal administration is contraindicated in patients with proctitis or anal fissures. Intraluminal administration of bisacodyl is used during colonic manometry for the assessment of the colonic neuromuscular function in children with treatment-refractory constipation. Bisacodyl can elicit high-amplitude propagating contractions and therefore helps to distinguish between patients with normal or impaired colonic propulsion [ 46 , 47 ]. A recent study including 165 children with treatment-refractory constipation found that in 93% of children intraluminal administration of bisacodyl induced high-amplitude propagating contractions, confirming the stimulating effect of bisacodyl on the colonic peristalsis in children [ 48 ]. However, good-quality evidence for the efficacy and safety of bisacodyl in children with FC is lacking [ 27 ]. Randomized controlled trials conducted in adults have shown that orally administered bisacodyl is effective and safe in patients with chronic constipation [ 49 , 50 ]. Promising results for the effectiveness and tolerance of long-term use of bisacodyl were reported by a recent retrospective study in 164 children with FC refractory to conventional treatment [ 51 ]. The median number of bowel movements increased from two to four times per week after 4 weeks of treatment and only minor adverse events were reported. However, these results should be interpreted with caution owing to the retrospective nature of the study.

Sodium picosulfate can only be administered orally and has a similar effect on colonic peristalsis as orally ingested bisacodyl [ 8 ]. Evidence for the use of sodium picosulfate for the treatment of FC in children is very scarce. Only the use of sodium picosulfate in combination with a high dose of PEG for disimpaction in children with constipation has been retrospectively studied showing promising results [ 52 , 53 ]. The highest dosage used for PEG ranged from four to eight sachets per day (13–14.7 g/sachet) and the highest sodium picosulfate dose ranged from 7.5 mg to 10 mg per day [ 52 , 53 ]. Common adverse effects of bisacodyl and sodium picosulfate include abdominal pain, nausea, and diarrhea [ 8 ]. Studies investigating treatment with only sodium picosulfate in children with constipation are lacking.

6.2 Anthraquinones

Senna contains various anthraquinones, which are metabolized by intestinal bacteria into their pharmacological active metabolites. These active metabolites stimulate colonic motility and prevent the reabsorption of water from the colon [ 28 ]. Senna can only be administered orally. Little evidence is available regarding the efficacy of senna for the treatment of FC in children. Only one randomized controlled trial with a small sample size ( n = 37) compared the differences in outcome after treatment with senna or mineral oil in children with chronic FC. Senna showed poorer results with respect to defection frequency and fecal incontinence after 3 months of follow-up [ 54 ]. Another crossover study compared senna to lactulose in children with constipation aged younger than 15 years, but showed no significant difference in the number of patients passing stools per day [ 55 ]. Senna was administered in a dosage of 10–20 mL daily and lactulose at 10–15 mL daily [ 55 ]. Common side effects are diarrhea, abdominal pain, nausea, and flatulence and young children are at risk of diaper rash, blisters, and peeling skin [ 8 , 56 ]. A literature review on the side effects of senna for children with constipation identified eight publications, consisting of case reports and case series, reporting perineal blisters and severe perineal rash [ 57 ]. In addition, a retrospective review of 796 children with FC or constipation, due to various organic diseases, investigated senna-related side effects. In 2.2% of this population, blisters and rash were reported, a correlation was found with higher doses of senna (median of 60 mg/day) and with children who were in diapers [ 57 ]. However, because of the retrospective design of this study and the high risk of bias, these results should be interpreted with caution.

7 Lubricants

Lubricants exert their laxative effect by softening or lubricating stools. Mineral oil, also known as liquid paraffin, is one of the most commonly used lubricants. It is an orally administered oily liquid comprising hydrocarbons obtained from petroleum and is not absorbed by the colon or small bowel [ 28 , 58 ].

A small number of RCTs have compared mineral oil with other laxatives such as PEG, lactulose, and senna. A Cochrane systematic review included two studies comparing PEG and mineral oil, and showed no significant difference in the increase of defecation frequency after 1 month of treatment [ 26 ]. However, the quality of the studies was very low because of sparse data and a high risk of bias [ 26 , 59 , 60 ]. However, mineral oil is suggested to be more effective than lactulose and senna for the treatment of FC in children [ 26 ]. Two RCTs comparing mineral oil with lactulose were included in the Cochrane review and showed a significant difference in stools per week (mean difference of 4.94) favoring mineral oil, but again the quality of evidence was low because of the small sample size and risk of bias [ 26 , 61 , 62 ]. One randomized controlled trial with a small sample size reported a higher defecation frequency and less fecal incontinence for mineral oil compared with senna [ 54 ].

Mineral oil is considered to be safe for the treatment of FC in children and the most common side effects, such as abdominal pain, nausea, vomiting, diarrhea, and flatulence, are generally mild [ 26 ]. Another adverse event is the leakage of mineral oil out of the anus, which can result in irritated skin around the anus and cause stains on clothes [ 8 ]. Over the years, multiple cases of severe adverse events, such as granulomas of the intestinal tract and lipoid pneumonia, have been reported [ 58 , 63 , 64 ]. Therefore, the Committee on Safety of Medicines advises that mineral oil should not be administered to children aged under 3 years. In addition, children with swallowing difficulties should also not receive mineral oil because they are at a greater risk of aspiration and developing lipoid pneumonia. Mineral oil is best avoided in children with coagulation disorders because there is a theoretic concern that long-term use of mineral oil reduces the absorption of fat-soluble vitamins [ 58 , 65 ].

Enemas are rectally administered fluids containing ingredients that can cause an increase in gut motility or intestinal fluid secretion. Some enemas contain multiple ingredients and combine both mechanisms of action [ 8 ]. The effect usually occurs within minutes after administration. Enemas are predominantly used for fecal impaction and are not the first choice for maintenance treatment of children with FC [ 6 ]. Several different enemas solutions are currently used in practice for the treatment of FC in children. Sodium docusate is a surface-active agent that stimulates the retention of water in the stools, which softens the stools and exerts the lubricating effect [ 28 ]. Reported side effects include abdominal pain and anal discomfort [ 21 ]. Sodium lauryl sulfoacetate softens the feces by redistributing the water that is bound to hard feces. This enema does not exert an osmotic effect and is predominantly prescribed in infants [ 8 ]. Sodium phosphate enemas contain a hyperosmolar phosphate solution and are contraindicated for patients with or suspected of Hirschsprung’s disease or renal insufficiency. These patients are at a greater risk of developing hyperphosphatemia [ 8 ]. Other adverse events are mostly minor and include abdominal pain, emesis, and diarrhea [ 66 ]. Some enemas contain a combination of ingredients, for example, an enema consisting of docusate, magnesium citrate, mineral oil, and sodium phosphate [ 67 ].

The effect of enemas on disimpaction has been investigated by a limited number of studies. A systematic review included two studies comparing the effect of oral PEG to enemas (dioctyl sulfosuccinate sodium and milk and molasses) for disimpaction in children aged 1–17 years with FC [ 68 ]. The primary outcome was treatment success, defined as the absence of fecaloma in one study and no need to visit the emergency department in the other study [ 68 ]. A meta-analysis of the two studies showed a significantly reduced success rate for PEG; however, the difference was minor (risk ratio of 0.83) and therefore not clinically relevant. Secondary outcomes reported a higher defecation frequency for PEG, but also an increased risk of watery stools and fecal incontinence [ 68 ]. The results of this systematic review, however, should be interpreted with caution because of the high risk of bias of the included studies and the sparse data. Recently, the short-term efficacy and safety of promelaxin microenemas compared to PEG in infants and toddlers with FC were explored in a randomized controlled non-inferiority trial [ 69 ]. In accordance with previous studies, both treatments were considered equally effective. The primary outcome was the response rate, defined as three or more stools per week and an average increase of one stool per week if the baseline frequency was already three bowel movements per week. The study reported 183 adverse events, but concluded that these were all unrelated to both treatment arms. However, no further information nor explanation about these adverse events and their relation with the treatments was given [ 69 ].

The efficacy of different enema solutions used in pediatric emergency departments was investigated by a retrospective study in 768 children with constipation with and without underlying anatomical disorders [ 67 ]. The enema solutions included sodium phosphate, pink lady, and soap suds, and the study reported that there was no significant association between stool output (small, medium, or large) and enema solution. In addition, a low rate of side effects was reported for all enemas, side effects were minor and consisted mostly of abdominal pain and vomiting [ 67 ]. It is worth mentioning that soap suds are widely used in emergency departments; however, little evidence is available supporting their efficacy and safety [ 70 ]. In the past, several case reports have mentioned soap-induced colitis, raising safety concerns regarding the treatment of constipation with soap suds [ 71 , 72 ]. It is recommended to use other, more extensively studied treatments for disimpaction, such as those mentioned above [ 72 ]. A recent retrospective case series report from Japan explored the use of olive oil enemas as adjunctive treatment in 118 children with severe chronic constipation, with and without underlying medical disorders [ 73 ]. The authors reported that the use of olive oil enemas in combination with glycerin was effective in 79.6% of children with FC. Effectiveness was defined as achieving fecal disimpaction within several visits to the outpatient department, in which the absence of previous symptoms was considered as fecal disimpaction [ 73 ].

The long-term use of enemas has only been investigated by one randomized controlled trial. The study explored the regular use of enemas as an addition to conventional maintenance treatment in 100 severely constipated children (aged 8–18 years) with a follow-up of 52 weeks [ 74 ]. Conventional treatment consisted of education, behavioral strategies, and PEG. The study showed no additional positive effect for defecation frequency, fecal incontinence frequency, and overall treatment success and suggested that enemas should not be used for maintenance treatment.

9 Novel Therapies

In recent years, several new pharmacological treatment options have been investigated for childhood FC. For most of these medications, trials were first performed in adults and subsequently in the pediatric population. Applying knowledge obtained from adult studies to the pediatric population requires great care because of the differences in physiology and pharmacokinetics between children and adults [ 21 ]. As previously mentioned, psychological and behavioral factors play a major role in the pathophysiology of FC in children. Withholding behavior is considered to be the most contributing factor in the development of constipation in children, whereas this barely plays a role in the pathophysiology of FC in adults. Hence, it is important that studies evaluating the efficacy and safety of new drugs for the treatment of FC are conducted in the pediatric population. International recommendations for trials in children with FC recommend to conduct randomized, double-blind, placebo-controlled clinical trials with a parallel group [ 75 ]. Furthermore, FC should be defined per the Rome IV criteria, the follow-up period should at least be 8 weeks, and treatment success should be defined as no longer fulfilling the Rome IV criteria [ 75 ].

9.1 Prosecretory Agents

Lubiprostone, linaclotide, and plecanatide are prosecretory agents that modulate epithelial channels in the intestine, stimulating the secretion of fluids into the intestinal lumen and increasing stool volume, aiming to accelerate colonic transit [ 21 ]. Lubiprostone activates the type 2 chloride channels on enterocytes, which leads to an increased intestinal fluid secretion [ 76 ]. Multiple RCTs have been performed in adults with FC, and have shown that lubiprostone is safe and increases spontaneous bowel movements in adults [ 77 , 78 , 79 , 80 ]. Less evidence is available in the pediatric population. An open-label study including 127 children aged 3–17 years and ≥ 12 kg in weight suggested that lubiprostone is efficacious and safe for children with FC [ 81 ]. However, this study did not include a control group and therefore carried a risk of a placebo effect. In a recent large, multicenter, double-blind RCT, the effectiveness and safety of lubiprostone in 606 children with FC aged 6–17 years was investigated [ 82 ]. The authors concluded that lubiprostone can be considered safe for children aged 6 years or older, but the drug showed no significant difference in the improvement of spontaneous bowel movements compared to placebo after 9 weeks of treatment [ 82 ]. Another multicenter open-label trial investigated the safety of lubiprostone in children with FC aged 6–17 years (mean age 10.3 years). In line with the other trials, the drug was well tolerated in children [ 83 ]. Side effects of lubiprostone are generally minor and include nausea, vomiting, abdominal pain, and diarrhea [ 82 ]. All three studies mentioned above performed a subgroup analysis for efficacy and safety based on the administered dose. Children were allocated to a dosage of 12 µg once a day, 12 µg twice a day, or 24 µg once a day, depending on their weight. None of the studies reported any difference between the dosages for efficacy and safety [ 81 , 82 , 83 ].

Linaclotide increases the intestinal fluid secretion by activating the guanylate cyclase C receptor [ 21 ]. Linaclotide has been proven to be safe and efficient for the treatment of FC and irritable bowel syndrome with constipation in adults [ 84 , 85 ]. Thus far, only one retrospective non-controlled trial evaluated the use of linaclotide for the treatment of FC in 60 children with a median age of 13.9 years [ 86 ]. The study showed a positive clinical response based on the physician’s assessment in 45% of children with FC ( n = 60/93) after 2.5 months of follow-up. However, 20% of all children ( n = 19/93), including children with irritable bowel syndrome with constipation, stopped using linaclotide because of side effects [ 86 ]. The occurrence of the most commonly reported adverse events, such as diarrhea and abdominal pain, was analyzed per dose: 72 µg or 145 µg. In the subgroup receiving 72 µg, 60% ( n = 6/10) of the patients reported an adverse event compared with 28% ( n = 14/50) in the subgroup receiving 145 µg. The safety and efficacy of different dosages of linaclotide in children aged 6–17 years with FC were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial; however, the study has not yet been published (NCT02559570). Another phase III study is currently recruiting patients and will also investigate linaclotide in children with FC (aged 6–17 years) [NCT04026113]. In addition, there is an ongoing phase II study that investigates the effect of linaclotide in younger children with FC (aged 2–5 years) [NCT04110145].

Plecanatide is a new guanylate cyclase C receptor agonist, which is considered safe and effective in adults with chronic idiopathic constipation [ 87 , 88 , 89 ]. However, to date, no studies on the use of plecanatide in the pediatric population have been published. More evidence will become available soon, as two ongoing phase II studies in the pediatric population are registered. These studies evaluate the efficacy and safety of plecanatide in adolescents with chronic idiopathic constipation based on the Rome III criteria (NCT03120520) and in children (aged 6–18 years) with irritable bowel syndrome with constipation (NCT03596905).

9.2 Serotonergic Agents

Serotonin or 5-hydroxytryptamine (5-HT) is a central and enteric neurotransmitter that binds to the 5-HT4 receptors in the intestine. This results in the increase of fluid secretion and gut motility, which promotes the passage of stool [ 21 ]. Multiple 5-HT4 agonists have been developed, including prucalopride, velusetrag, and naronapride.

Prucalopride is a selective, high-affinity 5-HT4 receptor agonist. A meta-analysis of 16 studies has shown that the drug is well tolerated and effective for adults with constipation [ 90 ]. Prucalopride increases the frequency of spontaneous bowel movements per week and the side effects are acceptable and minor [ 90 ]. Two studies in the pediatric population have been published. An open-label phase I study in 37 children, who all received a single dose of 0.03 mg/kg of prucalopride, suggested that prucalopride was well tolerated in children (aged 4–12 years) with FC [ 91 ]. The authors also suggested that the drug could potentially be clinically effective, based upon positive findings for defecation frequency, stool consistency, and fecal incontinence frequency [ 91 ]. However, a subsequent multicenter, randomized, placebo-controlled, double-blind, phase III trial assessing the safety and efficacy of prucalopride in 213 children with FC concluded that prucalopride was no more effective than placebo [ 92 ]. Children with a body weight under 50 kg received 0.04 mg/kg of prucalopride once daily, and children weighing > 50 kg received 2 mg of prucalopride once daily, no differences between both subgroups were found. At present, an ongoing phase III clinical trial is investigating the efficacy and long-term safety of prucalopride in 255 children with FC (NCT04759833).

Velusetrag and naronapride are also 5-HT4 receptor agonists and phase II trials in adults with chronic constipation show positive results on bowel movement frequency [ 93 , 94 ]. No studies have been performed in the pediatric population yet and there are no future studies planned.

9.2.1 Differences Between Adults and Children

The difference in the effect of lubiprostone and prucalorpide compared with the adult population can possibly be related to the fact that withholding behavior plays a major role in the pathophysiology of FC in children. Pharmacological treatment may soften the stool and improve gut motility, but it is not expected to overcome withholding behavior [ 92 ]. This raises questions regarding the preferred study design for future trials in children with FC. It could be suggested to exclude children with withholding behavior in future studies investigating specific drugs that have been proven effective in adults but not yet in children, in order to assess whether children without withholding behavior do improve after treatment. However, this would also exclude a proportion of children fulfilling the Rome IV criteria for FC and this would severely limit the generalizability of these study results. Another factor that should be considered when comparing pediatric and adult studies are the differences in diagnostic criteria and the primary outcome measures used in these studies [ 95 ].

9.3 Bile Acids

Endogenous deconjugated bile salts increase intraluminal fluid secretion and colonic motility by activating bile acid receptors in enteric neurons [ 21 , 96 ]. Bile salts comprise free bile acids. Chenodeoxycholic acid is a primary bile acid that improves colonic transit times and increases the number of bowel movement in adults [ 97 , 98 ]. Fecal bile acid composition was determined in 165 children with and without FC in an observational study [ 99 ]. The study showed that a small subset of children with FC ( n = 6/73) had an altered metabolism of chenodeoxycholic acid, suggesting that bile acids may play a role in childhood FC [ 99 ]. No studies have been performed in the pediatric population exploring the use of bile acids for treatment of FC. Elobixibat is a novel drug that affects bile salt metabolism by inhibiting ileal bile acid transporters. Normally, most bile salts are bound to the bile acid transporters in the ileum and only a small concentration continues to the colon. Elobixibat inhibits the reabsorption of bile acids in the small intestine, resulting in higher concentrations of bile acids in the colon. A recent systematic review and meta-analysis in Japanese adults with chronic idiopathic constipation according to the Rome criteria included three RCTs and showed a significant improvement in weekly spontaneous bowel movements compared with placebo [ 100 ]. Two other RCTs, which were not included in the systematic review also showed that elobixibat increased colonic transit and softened stool consistency [ 101 , 102 ]. Currently, no pediatric studies on the use of elobixibat for FC have been performed nor are these currently being conducted.

9.4 Cholinesterase Inhibitors

Pyridostigmine is an acetylcholinesterase inhibitor that increases the availability of acetylcholine in the neuromuscular junctions. This results in an improvement of transmission of impulses and thereby stimulates the gastrointestinal motility [ 21 , 103 ]. A small number of studies regarding the efficacy and safety of pyridostigmine for the treatment of FC are available, and even less for FC in the pediatric population. An observational case series of 13 adults with slow-transit constipation ( n = 6) or intestinal pseudo-obstruction ( n = 7) investigated the effect of pyridostigmine on constipation symptoms. Patients with slow-transit constipation showed no improvement in symptoms, in contrast to the group with recurrent pseudo-obstruction that did show an improvement in symptoms [ 104 ]. Similar results for improvement in defecation frequency and stool consistency were found in a randomized double-blind controlled study comparing pyridostigmine and bisacodyl in 68 adults with refractory chronic constipation [ 103 ]. A case series of four children with gastrointestinal motility disorders reported decreased abdominal distention, increased defection frequency, improved enteral feeding tolerance, and minor side effects after treatment with pyridostigmine [ 105 ]. At present, no further studies investigating the efficacy and safety of this drug are being performed in children with constipation.

10 Botulinum Toxin Injection (Botox ® )

If patients do not respond to optimal conservative treatment, one of the last treatment options is the botulinum toxin injection (BTI), also known as Botox ® , in the anal sphincter [ 6 ]. Botulinum toxins inhibit the release of acetylcholine from neurons, resulting in partial chemical paralysis of the muscle and thereby relaxation of the injected anal sphincter muscles. A BTI is usually administered under general anesthesia. It is generally injected into the internal anal sphincter, dividing the total dose over four to eight injections each in different sites of the muscle [ 106 ]. The pharmacological effect of botulinum toxin is transient because over time new neuromuscular junctions may develop and the function of the original neural endplate is restored [ 107 ]. The relaxing effect lasts 3–6 months; therefore, patients often require one or more subsequent injections [ 108 ]. Botox ® dosages used in studies investigating BTI in children with defecation disorders vary widely, with a range from 12 to 200 U in total, but 100 U seems to be a commonly used dosage [ 109 ]. In addition, the number of injections and the specific sites of the injections in the anal sphincter also differ between studies. Currently, there are no guidelines available that provide advice for the dosage of BTI in children with FC.

A BTI has been shown to be effective and safe for the treatment of children with impaired rectal evacuation due to Hirschsprung’s disease or internal anal sphincter achalasia [ 109 , 110 , 111 , 112 ]. These data, however, cannot simply be applied to children with FC, who have a normal recto-anal inhibitory reflex. Nevertheless, a BTI could help in breaking through the vicious cycle of stool withholding in children with FC. Because of the temporary paralysis of the anal sphincter, withholding stools is not possible and stool consistency becomes softer, which results in less pain during defecation. A BTI is used in clinical practice as a treatment of last resort; however there is a lack of RCTs providing evidence for the efficacy of BTI in children with FC. A recent prospective cohort study investigated the effect of BTI on constipation symptoms in children with FC ( n = 17).

[ 106 ] After 2 months of follow-up, 47% of the caregivers of the children ( n = 7/15) reported that the BTI had an overall positive effect and the outcome measures of abdominal pain severity and constipation severity improved significantly compared with baseline. After 4 months, 60% of the caregivers ( n = 6/10) reported an overall positive effect. Three children with FC received an additional injection between 2 and 4 months follow-up and were analyzed separately [ 106 ]. This was a non-randomized non-controlled study with a small FC population ( n = 17), so these results should be interpreted with great care. A recent randomized controlled study included 40 pediatric patients with FC (according to Rome IV criteria) with obstruction defecation syndrome (according to the National Institute for Health and Care Excellence definition) [ 113 ]. The study explored the role of a BTI as an addition to conventional treatment for FC, which consisted of a modified diet, toilet training, and stimulant laxatives. The authors concluded that the addition of a BTI did not result in significant improvement of defecatory problems assessed by the Rintala score [ 113 ]. However, it should be considered that the Rintala score is established to evaluate fecal continence and it does not necessarily reflect constipation severity.

11 Prognosis and Follow-Up

A large proportion of children with FC respond well to treatment with acceptable side effects and will recover within a year [ 7 ]. The prognosis and prognostic factors of FC in children were investigated in a systematic review, including 14 heterogeneous prospective follow-up studies with a total of 1752 children [ 7 ]. This systematic review reported that half of the children treated for FC were recovered and taken off laxatives after 6–12 months of follow-up. An additional 10% were symptom free, but still being treated with laxatives. After a follow-up of 1–2 years and 5–10 years, the recovery rate was 58% and 56%, respectively [ 7 ]. Children treated in a pediatric gastroenterology department showed a higher recovery rate than children treated in general pediatric departments [ 7 ]. In contrast to the large group of children that will recover, a sizable group remains symptomatic regardless of treatment and can remain symptomatic into adolescence or adulthood [ 114 , 115 , 116 ].

Research on factors influencing the clinical course of FC in children is limited [ 6 ]. A systematic review attempted to perform a meta-analysis on prognostic factors, but because of the large variations in prognostic factors between studies this was not possible [ 7 ]. Some studies have suggested that a longer period of time between the age of onset and the first presentation is negatively related to recovery [ 116 , 117 ]. There is strong evidence that demographics such as sex and a positive family history have no prognostic value [ 6 ]. A recent prospective study in 122 children with FC (defined by the Rome III criteria) explored the association between self-efficacy, the belief that one has the skill to succeed at a goal, and treatment success [ 118 ]. Treatment success was defined as having at least three bowel movements and no fecal incontinence episodes in the third week of treatment. Patients who were successfully treated, scored higher on the self-efficacy questionnaire before the clinic visit, immediately after, and at a follow-up of 3 weeks than the group that did not respond to treatment [ 118 ]. This study showed that self-efficacy is associated with treatment success of FC in children after a short-term follow-up and the authors suggest that enhancing self-efficacy in children with FC may be a good addition to improve treatment outcome [ 118 ]. Another factor that is crucial for treatment success is treatment adherence. Poor adherence to pharmacological maintenance treatment is common in children and is considered to play an important role in poor outcomes [ 119 , 120 , 121 ]. Taste and palatability of orally administered drugs can be a great problem for the tolerability of children for medications and should be considered when deciding on treatment options [ 122 ]. Evidence on treatment adherence in children with FC is limited. In a recent cross-sectional survey study including 115 children with FC, as defined by the Rome IV criteria, adherence to PEG treatment was evaluated and associated factors were identified [ 123 ]. This study showed that poor treatment adherence is common in children with FC, as only 37% of all children were adherent to the treatment with PEG. Treatment inconvenience, dissatisfaction with treatment, and the emotional impact of a child’s constipation symptoms were identified as factors that may have a negative effect on treatment adherence [ 123 ].

12 Conclusions

Pediatric FC is a common problem. Diagnosis is made based on the Rome IV criteria after evaluation of a thorough clinical history and physical examination. Additional diagnostic testing is only indicated when an organic cause is suspected or if children do not respond to treatment despite optimal treatment. The pathophysiology of FC is considered to be multifactorial, and withholding behavior plays a major role. The first step in treating FC involves education, demystification, lifestyle advice, and toilet training (when developmental age is at least 4 years). Pharmacological treatment with laxatives consists of three steps: disimpaction, maintenance treatment, and ultimately weaning if possible. Polyethylene glycol is considered as the first choice of laxative for both disimpaction and maintenance treatment. For disimpaction, high-dose PEG is recommended and if PEG is not available enemas are second choice. The osmotic laxative lactulose is the second option for maintenance treatment. Stimulant laxatives (bisacodyl or senna) or lubricants (mineral oil) can be considered as alternative or additional treatment options if children are not responsive to the initial treatment. A large proportion of children remains symptomatic after 6–12 months of treatment; therefore, it is necessary that new pharmacological options are being developed and investigated. Novel drugs, such as lubiprostone, linaclotide, prucalopride, elobixibat, and pyridostigmine, show promising results. However, high-quality randomized controlled clinical trials in the pediatric population are needed to establish the efficacy and safety for these new treatment options, including the investigation of optimal dosages. Pharmacological pediatric trials should consider the different pathophysiology, definition of FC, and primary outcomes for the pediatric population compared to adults when setting up the study design. If children remain symptomatic despite optimal conservative treatment, BTIs in the anal sphincter can be considered as an alternative treatment option.

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Department of Pediatric Gastroenterology and Nutrition, Emma Children’s Hospital/Academic Medical Center, Meibergdreef 9, 1105, Amsterdam, AZ, The Netherlands

Anna de Geus, Ilan J. N. Koppen, Marc A. Benninga & Merit M. Tabbers

Department of Clinical Pharmacy, Erasmus MC University Medical Center, Rotterdam, The Netherlands

Robert B. Flint

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Anna de Geus, Robert B. Flint, and Merit M. Tabbers have no conflicts of interest that are directly relevant to the content of this article. Ilan J.N. Koppen has received consulting fees from Mahana Therapeutics, a speaker fee from Wellspect, and funding for an investigator-initiated study from Wellspect. All of the above were related to the topic of functional gastrointestinal disorders, but not related to any pharmacological treatment. Marc A. Benninga is consultant for Mallinckrodt, Shire, Danone, FrieslandCampina, HIPP, Norgine, Coloplast, United Pharmaceuticals, and Wellspect. All honoraria were paid to the hospital (Amsterdam UMC).

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de Geus, A., Koppen, I.J.N., Flint, R.B. et al. An Update of Pharmacological Management in Children with Functional Constipation. Pediatr Drugs 25 , 343–358 (2023). https://doi.org/10.1007/s40272-023-00563-0

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