Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic.

Importance: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation. Objectives: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials. Design, Setting, and Participants: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024. Main Outcomes and Measures: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking. Results: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence. Conclusions and Relevance: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

Design Process and Utilization of a Novel Clinical Decision Support System for Neuropathic Pain in Primary Care: Mixed Methods Observational Study.

BACKGROUND: Computerized clinical decision support systems (CDSSs) have emerged as an approach to improve compliance of clinicians with clinical practice guidelines (CPGs). Research utilizing CDSS has primarily been conducted in clinical contexts with clear diagnostic criteria such as diabetes and cardiovascular diseases. In contrast, research on CDSS for pain management and more specifically neuropathic pain has been limited. A CDSS for neuropathic pain has the potential to enhance patient care as the challenge of diagnosing and treating neuropathic pain often leads to tension in clinician-patient relationships. OBJECTIVE: The aim of this study was to design and evaluate a CDSS aimed at improving the adherence of interprofessional primary care clinicians to CPG for managing neuropathic pain. METHODS: Recommendations from the Canadian CPGs informed the decision pathways. The development of the CDSS format and function involved participation of multiple stakeholders and end users in needs assessment and usability testing. Clinicians, including family medicine physicians, residents, and nurse practitioners, in three academic teaching clinics were trained in the use of the CDSS. Evaluation over one year included the measurement of utilization of the CDSS; change in reported awareness, agreement, and adoption of CPG recommendations; and change in the observed adherence to CPG recommendations. RESULTS: The usability testing of the CDSS was highly successful in the prototype environment. Deployment in the clinical setting was partially complete by the time of the study, with some limitations in the planned functionality. The study population had a high level of awareness, agreement, and adoption of guideline recommendations before implementation of CDSS. Nevertheless, there was a small and statistically significant improvement in the mean awareness and adoption scores over the year of observation (P=.01 for mean awareness scores at 6 and 12 months compared with baseline, for mean adoption scores at 6 months compared with baseline, and for mean adoption scores at 12 months). Documenting significant findings related to diagnosis of neuropathic pain increased significantly. Clinicians accessed CPG information more frequently than they utilized data entry functions. Nurse practitioners and first year family medicine trainees had higher utilization than physicians. CONCLUSIONS: We observed a small increase in the adherence to CPG recommendations for managing neuropathic pain. Clinicians utilized the CDSS more as a source of knowledge and as a training tool than as an ongoing dynamic decision support.

Multimorbidity, eHealth and implications for equity: a cross-sectional survey of patient perspectives on eHealth.

OBJECTIVE: There is increasing awareness of the burden of medical care experienced by those with multimorbidity. There is also increasing interest and activity in engaging patients with chronic disease in technology-based health-related activities ('eHealth') in family practice. Little is known about patients' access to, and interest in eHealth, in particular those with a higher burden of care associated with multimorbidity. We examined access and attitudes towards eHealth among patients attending family medicine clinics with a focus on older adults and those with polypharmacy as a marker for multimorbidity. DESIGN: Cross-sectional survey of consecutive adult patients attending consultations with family physicians in the McMaster University Sentinel and Information Collaboration practice-based research network. We used univariate and multivariate analyses for quantitative data, and thematic analysis for free text responses. SETTING: Primary care clinics. PARTICIPANTS: 693 patients participated (response rate 70%). INCLUSION CRITERIA: Attending primary care clinic. EXCLUSIONS: Too ill to complete survey, cannot speak English. RESULTS: The majority of participants reported access to the internet at home, although this decreased with age. Participants 70 years and older were less comfortable using the internet compared with participants under 70. Univariate analyses showed age, multimorbidity, home internet access, comfort using the internet, privacy concerns and self-rated health all predicted significantly less interest in eHealth. In the multivariate analysis, home internet access and multimorbidity were significant predictors of disinterest in eHealth. Privacy and loss of relational connection were themes in the qualitative analysis. CONCLUSION: There is a significant negative association between multimorbidity and interest in eHealth. This is independent of age, computer use and comfort with using the internet. These findings have important implications, particularly the potential to further increase health inequity.