Patient-Centered Research Research Articles

Disruptive Innovation in Dentistry: What It Is and What Could Be Next

Dentistry is a technically oriented profession, and the health care sector is significantly influenced by the ubiquitous trend of digitalization. Some of these digital developments have the potential to result in disruptive changes for dental practice, while others may turn out to be just a pipedream. This Discovery! essay focuses on innovations built on artificial intelligence (AI) as the center-technology influencing 1) dental eHealth data management, 2) clinical and technical health care applications, and 3) services and operations. AI systems enable personalized dental medicine workflows by analyzing all eHealth data gathered from an individual patient. Besides dental-specific data, this also includes genomic, proteomic, and metabolomic information and therefore facilitates optimized and personalized treatment strategies and risk management. Based on the power of AI, the triangular frame of “data”/“health care”/“service” is supplemented by technological advancements in the field of social media, Internet of things, augmented and virtual reality, rapid prototyping, and intraoral optical scanning as well as teledentistry. Innovation continues to be critical to tackle dental problems until its routine implementation based on sound scientific evidence. Novel technologies must be viewed critically in relation to the cost-benefit ratio and the ethical implications of a misleading diagnosis or treatment produced by AI algorithms. Highly sensitive eHealth data must be handled responsibly to enable the immense benefits of these technologies to be realized for society. The focus on patient-centered research and the development of personalized dental medicine have the potential to improve individual and public health, as well as clarify the interconnectivity of disease in a more cost-effective way.

Step-by-step Strategies for an Integrated Patient-Oriented Research: Lessons Learned from a Multicentered Study

Introduction: The literature on Patient-Oriented Research (POR) and, more specifically, on the collaborative experience between research teams and patient partners (PPs), varies in the way it reports experiences. In Canada, since a few years, POR has been upgraded and literature now provides several guidelines and tools to support effective engagement of PPs in research. However, scientific literature most often presents elements from the researchers’ or from the PPs’ perspective, but rarely from both simultaneously. Objective: This paper objective is to enhance the current literature and provide examples of day-to-day pre, per, and post POR activities. Methods: Based on the 4 guiding principles of the Strategy for POR of the Canadian Institutes of Health Research, we present a step-by-step description of our POR strategies used during our research project. We also give concrete examples and tips shared by PPs and researchers. Discussion and conclusion: We favored 3 steps to engage positively our team in a POR approach. These steps led us to 3 main lessons. First, there is a necessity to adapt training on POR. Second, researchers must demonstrate open-mindedness and humility throughout the collaboration. Third, PPs’ recognition needs to be emphasized including a normalization of financial aspect. The reflections made in this article will help, hopefully, research teams to begin their patient-centered research process by building on the previous experiences of other teams, such as ours.

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Routinely collected data and patient-centred research in anaesthesia and peri-operative care: a narrative review.

SummaryRandomised controlled trials are the gold standard in clinical research, but remain rare due to their expense and a perceived lack of ‘real‐world’ applicability. At the same time, there has been an exponential increase in routinely collected data which presents opportunities for audit, quality improvement, adverse event reporting and more efficient clinical research. Registry‐based research benefits from reduced cost, large sample size and real‐world applicability, with methodological developments, particularly registry‐based randomised controlled trials and causal inference techniques, showing promise. Limitations include data quality and validity, the need for data linkage, the restrictions of fixed data fields, regulatory barriers, and privacy and security concerns. However, the principal factor hampering current efforts is a lack of anaesthesia‐specific datasets in the UK and the fact that most surgical registries do not collect any anaesthetic data. This presents an opportunity for anaesthetists, through enhanced engagement and collaboration, to influence and improve the design of these datasets and increase the value and volume of data collected. Better datasets, coupled with a growing appreciation of new analysis methodologies, would allow significant progress towards realising the potential of routinely collected data for patient benefit. At the same time, work should begin on the development of a minimum dataset for anaesthesia to underpin new data sharing networks and, ideally, a national registry of anaesthesia.

Assessing the practice of data quality evaluation in a national clinical data research network through a systematic scoping review in the era of real-world data.

ObjectiveTo synthesize data quality (DQ) dimensions and assessment methods of real-world data, especially electronic health records, through a systematic scoping review and to assess the practice of DQ assessment in the national Patient-centered Clinical Research Network (PCORnet).Materials and MethodsWe started with 3 widely cited DQ literature—2 reviews from Chan et al (2010) and Weiskopf et al (2013a) and 1 DQ framework from Kahn et al (2016)—and expanded our review systematically to cover relevant articles published up to February 2020. We extracted DQ dimensions and assessment methods from these studies, mapped their relationships, and organized a synthesized summarization of existing DQ dimensions and assessment methods. We reviewed the data checks employed by the PCORnet and mapped them to the synthesized DQ dimensions and methods.ResultsWe analyzed a total of 3 reviews, 20 DQ frameworks, and 226 DQ studies and extracted 14 DQ dimensions and 10 assessment methods. We found that completeness, concordance, and correctness/accuracy were commonly assessed. Element presence, validity check, and conformance were commonly used DQ assessment methods and were the main focuses of the PCORnet data checks.DiscussionDefinitions of DQ dimensions and methods were not consistent in the literature, and the DQ assessment practice was not evenly distributed (eg, usability and ease-of-use were rarely discussed). Challenges in DQ assessments, given the complex and heterogeneous nature of real-world data, exist.ConclusionThe practice of DQ assessment is still limited in scope. Future work is warranted to generate understandable, executable, and reusable DQ measures.

Canadian Association of Radiologists White Paper on De-identification of Medical Imaging: Part 2, Practical Considerations.

The application of big data, radiomics, machine learning, and artificial intelligence (AI) algorithms in radiology requires access to large data sets containing personal health information. Because machine learning projects often require collaboration between different sites or data transfer to a third party, precautions are required to safeguard patient privacy. Safety measures are required to prevent inadvertent access to and transfer of identifiable information. The Canadian Association of Radiologists (CAR) is the national voice of radiology committed to promoting the highest standards in patient-centered imaging, lifelong learning, and research. The CAR has created an AI Ethical and Legal standing committee with the mandate to guide the medical imaging community in terms of best practices in data management, access to health care data, de-identification, and accountability practices. Part 2 of this article will inform CAR members on the practical aspects of medical imaging de-identification, strengths and limitations of de-identification approaches, list of de-identification software and tools available, and perspectives on future directions.

Canadian Association of Radiologists White Paper on De-Identification of Medical Imaging: Part 1, General Principles.

The application of big data, radiomics, machine learning, and artificial intelligence (AI) algorithms in radiology requires access to large data sets containing personal health information. Because machine learning projects often require collaboration between different sites or data transfer to a third party, precautions are required to safeguard patient privacy. Safety measures are required to prevent inadvertent access to and transfer of identifiable information. The Canadian Association of Radiologists (CAR) is the national voice of radiology committed to promoting the highest standards in patient-centered imaging, lifelong learning, and research. The CAR has created an AI Ethical and Legal standing committee with the mandate to guide the medical imaging community in terms of best practices in data management, access to health care data, de-identification, and accountability practices. Part 1 of this article will inform CAR members on principles of de-identification, pseudonymization, encryption, direct and indirect identifiers, k-anonymization, risks of reidentification, implementations, data set release models, and validation of AI algorithms, with a view to developing appropriate standards to safeguard patient information effectively.

Engaging patients and family members to design and implement patient-centered kidney disease research

Plain English summaryWe need more research projects that partner and engage with patients and family members as team members. Doing this requires that patients and family members set research priorities and fully participate in research teams. Models for this patient and family member engagement as research partners can help increase patient centered outcomes research. In this article, we describe how we have successfully engaged patients with kidney disease and family members as Co-Investigators on a 5-year research project testing a health system intervention to improve kidney disease care.BackgroundThis article describes a method for successful engagement of patients and family members in all stages of a 5-year comparative effectiveness research trial to improve transitions of care for patients from chronic kidney disease to end-stage kidney disease.MethodsThis project utilized the Patient-Centered Outcomes Research Institute’s conceptual model for engagement with patients and family members. We conducted a qualitative analysis of grant planning meetings to determine patient and family member Co-Investigators’ priorities for research and to include these engagement efforts in the research design. Patient and family member Co-Investigators partnered in writing this paper.ResultsPatients and family members were successfully engaged in remote and in-person meetings to contribute actively to research planning and implementation stages. Three patient-centered themes emerged from our data related to engagement that informed our research plan: kidney disease treatment decision-making, care transitions from chronic to end-stage kidney disease, and patient-centered outcomes.ConclusionsThe model we have employed represents a new paradigm for kidney disease research in the United States, with patients and family members engaged as full research partners. As a result, the study tests an intervention that directly responds to their needs, and it prioritizes the collection of outcomes data most relevant to patient and family member Co-Investigators.Trial registrationNCT02722382.

Researchers, patients, and other stakeholders\u2019 perspectives on challenges to and strategies for engagement

BackgroundThere is growing interest in patient and stakeholder engagement in research, yet limited evidence about effective methods. Since 2012, the Patient-Centered Outcomes Research Institute (PCORI) has funded patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders as research partners in study planning, conduct, and dissemination. This requirement, unique among large healthcare research funders in the US, provides an opportunity to learn about challenges encountered and specific strategies used by PCORI-funded study teams. The primary objective of this study is to describe -- from the perspective of PCORI investigators and research partners—the most common engagement challenges encountered in the first two years of the projects and promising strategies to prevent and overcome these challenges.MethodsDescriptive information about investigators, partners, and their engagement was collected from investigators via annual (N = 235) and mid-year (N = 40) project progress reporting to PCORI, and from their partners (N = 260) via voluntary survey. Qualitative data were analyzed using content and thematic analyses.ResultsInvestigators and partners most often described engagement challenges in three domains: (1) infrastructure to support engagement, (2) building relationships, and (3) maintaining relationships. Infrastructure challenges related to financial and human resources, including funding support and dedicated staff, identifying diverse groups of partners, and partners’ logistical needs. Challenges for both building and maintaining relationships encompass a variety of aspects of authentic, positive interactions that facilitate mutual understanding, full participation, and genuine influence on the projects. Strategies to prevent or mitigate engagement challenges also corresponded overall to the same three domains. Both groups typically described strategies more generally, with applicability to a range of challenges rather than specific actions to address only particular challenges.ConclusionMeaningful engagement of patients and other stakeholders comes with challenges, as does any innovation in the research process. The challenges and promising practices identified by these investigators and partners, related to engagement infrastructure and the building and maintenance of relationships, reveal actionable areas to improve engagement, including organizational policies and resources, training, new engagement models, and supporting engagement by viewing it as an investment in research uptake and impact.

Personalized Medicine Coalition Releases New Patient-Centered Research Agenda

Personalized Medicine Coalition Releases New Patient-Centered Research Agenda

PCORnet® 2020: current state, accomplishments, and future directions

ObjectiveTo describe PCORnet, a clinical research network developed for patient-centered outcomes research on a national scale. Study Design and SettingDescriptive study of the current state and future directions for PCORnet. We conducted cross-sectional analyses of the health systems and patient populations of the 9 Clinical Research Networks and 2 Health Plan Research Networks that are part of PCORnet. ResultsWithin the Clinical Research Networks, electronic health data are currently collected from 337 hospitals, 169,695 physicians, 3,564 primary care practices, 338 emergency departments, and 1,024 community clinics. Patients can be recruited for prospective studies from any of these clinical sites. The Clinical Research Networks have accumulated data from 80 million patients with at least one visit from 2009 to 2018. The PCORnet Health Plan Research Network population of individuals with a valid enrollment segment from 2009 to 2019 exceeds 60 million individuals, who on average have 2.63 years of follow-up. ConclusionPCORnet’s infrastructure comprises clinical data from a diverse cohort of patients and has the capacity to rapidly access these patient populations for pragmatic clinical trials, epidemiological research, and patient-centered research on rare diseases.

Photovoice as a Participatory Research Tool in Amyotrophic Lateral Sclerosis.

Background:Photovoice is a qualitative research tool increasingly utilized in the healthcare field to understand the illness experience from the patient and caregiver perspective. This is the first study to evaluate photovoice in the context of amyotrophic lateral sclerosis (ALS).Objective:A patient and caregiver centered research tool was utilized to gain a greater understanding of challenges faced when living with ALS.Methods:Eight patients and three corresponding caregivers participating by taking photographs, writing descriptive text, and participating in individual and group interviews. Inductive thematic analysis was employed to uncover recurring themes.Results:Five main themes were identified; 1) facing the diagnosis, 2) loss of function, 3) isolation, 4) health system challenges, and 5) hope. Despite the devasting impact of ALS, the majority of participants reported a surprising amount of positivity in the face of receiving this difficult diagnosis, and demonstrated incredible creativity and adaptability to meet the ensuing loss of function. However, patients and caregivers discussed feelings of isolation and health care system challenges. The importance of hope was a strong and recurring theme.Conclusions:The photovoice research tool demonstrates the profound resilience of these participants, and challenges the medical community to find ways of fostering positivity and hope throughout the ALS disease course. Further clinic and community resources, education, and supports are needed to combat the sense of isolation and health care system challenges experienced by patients and their caregivers.

The Sheldon Friel Memorial Lecture 2020 It's not just about the teeth: Patient-centred Orthodontics.

The provision of high-quality health care involves many different aspects, including safety, effectiveness, efficiency, and patient centredness. In order for care to be truly patient centred requires patients' views being sought and considered, and this may be achieved through patient-centred research. Patient-centred research is fundamentally important in contemporary health care and has many benefits; for example, it ensures that research is relevant, identifies those aspects of care that are important to patients, provides information that is important to current and future patients, and allows the integration of patients' views regarding how services may be enhanced in the future. This paper provides an overview of how we currently involve patients in orthodontic research, what this means to the specialty and how we can enhance patient involvement in the future.

Diabetes ROADMAP: Teaching Guideline Use, Communication, and Documentation When Delivering the Diagnosis of Diabetes.

IntroductionMost interventions to date regarding breaking bad news focus on late-stage disease or disclosing a cancer diagnosis. Little attention has been given to delivery of chronic metabolic disease diagnoses such as prediabetes/type 2 diabetes.MethodsInformed by the American Diabetes Association standards of care and formative research conducted by our research team, we developed this curriculum through the six-step approach to curriculum development. The curriculum consists of a 2- or 3-hour intervention that teaches medical decision-making, interpersonal communication, and clinical documentation in the context of prediabetes and type 2 diabetes followed by role-play and clinical practice.ResultsAcross three cohorts, 53 clinicians completed the curriculum. Across the three iterations, learners rated the curricular intervention as worthwhile and delivered at an appropriate level. In a community hospital setting, learners scored significantly higher on a knowledge check than did a control group of six clinicians (p < .001). Learners in the community hospital also indicated high response efficacy and self-efficacy. At the academic medical center, simulated patients indicated high measures on the Diabetes Health Threat Communication Questionnaire.DiscussionThe moment of diagnosis presents a key opportunity to affect patients' perceptions of the disease. This curriculum guides clinicians in making the most of diagnosis delivery. Pairing of qualitative, patient-centered research alongside the iterative curriculum design process allows the curriculum to be adaptable and scalable to multiple settings and learner types.

Diabetes medication regimens and patient clinical characteristics in the national patient-centered clinical research network, PCORnet.

We used electronic medical record (EMR) data in the National Patient‐Centered Clinical Research Network (PCORnet) to characterize “real‐world” prescription patterns of Type 2 diabetes (T2D) medications. We identified a retrospective cohort of 613,203 adult patients with T2D from 33 datamarts (median patient number: 12,711) from 2012 through 2017 using a validated computable phenotype. We characterized outpatient T2D prescriptions for each patient in the 90 days before and after cohort entry, as well as demographics, comorbidities, non‐T2D prescriptions, and clinical and laboratory variables in the 730 days prior to cohort entry. Approximately half of the individuals in the cohort were females and 20% Black. Hypertension (60.3%) and hyperlipidemia (50.5%) were highly prevalent. Most patients were prescribed either a single T2D drug class (42.2%) or had no evidence of a T2D prescription in the EMR (42.4%). A smaller percentage was prescribed multiple T2D drug types (15.4%). Among patients prescribed a single T2D drug type, metformin was the most common (42.6%), followed by insulin (18.2%) and sulfonylureas (13.9%). Newer classes represented approximately 13% of single T2D drug type prescriptions (dipeptidyl peptidase‐4 inhibitors [6.6%], glucagon‐like peptide‐1 receptor agonists [2.5%], thiazolidinediones [2.0%], and sodium‐glucose cotransporter‐2 inhibitors [1.6%]). Among patients prescribed multiple T2D drug types, the most common combination was metformin and sulfonylureas (63.5%). Metformin‐based regimens were highly prevalent in PCORnet's T2D population, whereas newer agents were prescribed less frequently. PCORnet is a novel source for the potential conduct of observational studies among patients with T2D.

Gender and global health education, what is it about the Global South

Abstract Background International policy frameworks have strengthened advocacy for gender equality, as agreed in SDG 3. However, gender considerations in research and the related methodological approaches often focus on gender-oriented topics in the global North with little attention on gender perspectives in ostensibly neutral disciplines such as health, and with even less consideration in African societies. The aim is to illustrate how feminist research principles, sensitivity to gender relations and gender performance are cross-cutting and integral in the use of patient-centered methods, ethics and culture. Methods Material was taken from an ethnographic study based on in-depth qualitative interviews conducted with cancer patients in Accra, Ghana. Eight cases studies of women diagnosed of breast cancer, ovarian, endometrium or cervical cancer were selected for the present analysis. Results In highly gendered societies like Africa health research is shaped by the peculiar ethical considerations on gender and cultural issues. This leads to a situation where female researchers may have favourable opportunities for gathering qualitative material because of gender stereotypes. However, they face gendered expectations of their research participants during data collection periods, and this may provoke adverse reactions, if the researcher does not meet the expectations. Education into patient-centred methods, therefore, must strengthen competencies of health professionals to critically reflect their own gendered realities and confront masculinity and femininity reactions by research participants, while being culturally sensitive and ethical at the same time. Conclusions Advocacy for gender approaches in global health education is important but not sufficient. Action is needed to develop a methodological approach sensitive to the gendered conditions of patient-centred research in the Global South.

Cognitive functioning, patient health communication, and worry mediate pain predictive effects on health-related quality of life in youth with sickle cell disease.

The objective was to investigate the serial mediating effects of perceived cognitive functioning, patient health communication, and disease-specific worry in the relationship between pain and overall generic health-related quality of life (HRQOL) in youth with sickle cell disease (SCD) from the patient perspective. The pain, cognitive functioning, communication and worry scales from the Pediatric Quality of Life Inventory (PedsQL) Sickle Cell Disease Module and the PedsQL Multidimensional Fatigue Scale, and the PedsQL 4.0 Generic Core Scales were completed in a multisite national study by 233 youth with SCD of ages 5-18. Hierarchical multiple regression and serial multiple mediator model analyses were conducted to test the mediating effects of perceived cognitive functioning, health communication, and disease-specific worry as intervening variables in the association between the pain predictor variable and overall generic HRQOL. Pain predictive effects on overall generic HRQOL were serially mediated by cognitive functioning, health communication, and disease-specific worry. In predictive analytics models utilizing hierarchical multiple regression analyses with age and gender demographic covariates, pain, cognitive functioning, health communication, and worry accounted for 65% of the variance in patient-reported overall generic HRQOL (P<.001), representing a large effect size. Perceived cognitive functioning, patient health communication, and disease-specific worry explain in part the mechanism of pain predictive effects on overall generic HRQOL in youth with SCD. Identifying SCD-specific pain, perceived cognitive functioning, health communication, and disease-specific worry as predictor variables of overall generic HRQOL from the patient perspective may inform clinical interventions and future patient-centered clinical research.

Patient empowerment through engagement in bladder cancer research

BackgroundThe Bladder Cancer Advocacy Network's (BCAN) Patient Survey Network established a diverse bladder cancer patient community who contribute to the prioritization of bladder cancer research topics through surveys and summits. This study describes our experience establishing an online learning program to train this population in research methods specific to bladder cancer and to subsequently engage patients in various stages of bladder cancer research. MethodsWe created online learning modules that addressed scientific concepts related to bladder cancer, creating the patient empowerment through engagement in research (PEER) program. Bladder cancer patients and caregivers who completed the program were invited to participate in the annual BCAN Bladder Cancer Summit to develop research study concepts. We then facilitated the promoting implementation of patient engagement in research conference to identify methods of connecting patient research advocates with research teams and find ways to disseminate patient-centered outcomes research. ResultsAfter completing the online training, 2 cohorts of PEER trainees attended the 2017 (n = 19) and 2018 (n = 18) Bladder Cancer Summits. These research advocates contributed to the prioritization of bladder cancer research topics that appeared on the Patient Survey Network and developed 3 patient-centered research studies. BCAN research advocates participated in promoting implementation of patient engagement the following year (n = 57) and identified these priorities: (1) the need to expand the patient research advocate cohort, (2) the need to streamline links between patient research advocates and research teams, and (3) approaches for patient-centered dissemination of research results. ConclusionsThe PEER program provides an exemplar for disease-specific research training for fostering patient engagement in research. This framework can be extrapolated to facilitate patient engagement in the research of other disease processes and malignancies.

Increasing participation in research with therapy dogs: A qualitative study at a large urban mental health and addiction hospital.

The benefits of involving patients as partners in research across diverse medical and psychiatric settings are well established in the literature. However, researchers continue to struggle to access, engage and retain participants from hard-to-reach populations. The main objective of this study was to co-create pet therapy activities with patients admitted for serious and complex mental illness to a large urban mental health and addiction hospital. Informed by the principles of participatory action research methodology, we conducted focus group discussions with 38 inpatients in seven different clinical units. An experienced volunteer handler and a certified therapy dog helped facilitate our discussions. Participating researchers, recreational therapists, volunteer handlers and our participants all reported that the presence of a certified therapy dog at each of our discussions was integral to their success. Certified therapy dogs increased the motivation to participate in our study, helped to build rapport with participants and created connections in our discussions that enriched our data. To our knowledge our study is the first to demonstrate the value of using a therapy dog as a participatory research tool in a healthcare setting. The authors believe that therapy dogs are a low-tech intervention that could be used effectively to engage hard-to-reach populations in research about their treatment and care in a diverse range of medical settings. These findings support the creation of a pilot study to test the value of including therapy dogs in patient-centered research with vulnerable and hard-to-reach populations.