Data-Driven Hypothesis Generation in Clinical Research: What We Learned from a Human Subject Study?

Hypothesis generation is an early and critical step in any hypothesis-driven clinical research project. Because it is not yet a well-understood cognitive process, the need to improve the process goes unrecognized. Without an impactful hypothesis, the significance of any research project can be questionable, regardless of the rigor or diligence applied in other steps of the study, e.

The quality of data-driven hypotheses generated by inexperienced clinical researchers: A case study.

Objectives: We invited inexperienced clinical researchers to analyze coded health datasets and develop hypotheses. We recorded and analyzed their hypothesis generation process. All the hypotheses generated in the process were rated by the same group of seven experts by using the same metrics.

Comprehensive review of the heart failure management guidelines presented by the American College of Cardiology and the current supporting evidence.

Context: Heart failure (HF) is a chronic condition that affects the heart's functional capacity, resulting in symptoms such as fatigue, edema, and dyspnea. It affects millions of adults in the United States and presents challenges in optimizing treatment and coordinating care among clinicians. Additionally, the various classifications for HF and limited research on treatment outcomes in heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) further complicate the pharmacological management of patients with this disease.

Interoceptive bodily awareness in patients seeking pain relief with osteopathic manipulative treatment: an observational cohort pilot study.

Context: Interoceptive bodily awareness (IBA) is one's attentional focus on and relationship with comfortable and uncomfortable (e.g., pain) internal body sensations.

Type 2 Diabetes and Chronic Kidney Disease: An Opportunity for Pharmacists to Improve Outcomes.

Chronic kidney disease (CKD) is an important contributor to end-stage kidney disease, cardiovascular disease, and death in people with type 2 diabetes (T2D), but current evidence suggests that diagnosis and treatment are often not optimized. This review examines gaps in care for patients with CKD and how pharmacist interventions can mitigate these gaps. We conducted a PubMed search for published articles reporting on real-world CKD management practice and compared the findings with current recommendations.

Guideline-based management of metabolic dysfunction-associated steatotic liver disease in the primary care setting.

Background: The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is increasing worldwide. Primary care providers play a critical role in the screening, diagnosis, and management of MASLD and/or metabolic dysfunction-associated steatohepatitis (MASH), though they can face challenges in this setting, particularly where healthcare resources are limited and barriers to care exist. To address these challenges, several guidelines have been developed to provide evidence-based recommendations for the clinical assessment and management of patients with MASLD/MASH.

Making Sense of the Nonalcoholic Fatty Liver Disease Clinical Practice Guidelines: What Clinicians Need to Know.

Standards of care summarized in clinical practice guidelines for nonalcoholic fatty liver disease (NAFLD) offer clinicians a streamlined diagnostic and management approach based on the best available evidence. These recommendations have changed a great deal in recent years; today, there is a clear focus on screening for the early identification and risk stratification of patients at high risk of steatohepatitis and clinically significant fibrosis to promote timely referrals to specialty care when needed. This article reviews and provides the rationale for current guidelines for NAFLD screening, diagnosis, treatment, and monitoring and addresses barriers to providing evidence-based NAFLD care and how to overcome them.

Data-driven hypothesis generation among inexperienced clinical researchers: A comparison of secondary data analyses with visualization (VIADS) and other tools.

Objectives: To compare how clinical researchers generate data-driven hypotheses with a visual interactive analytic tool (VIADS, a visual interactive analysis tool for filtering and summarizing large datasets coded with hierarchical terminologies) or other tools.

Methods: We recruited clinical researchers and separated them into "experienced" and "inexperienced" groups. Participants were randomly assigned to a VIADS or control group within the groups.

Program ACTIVE II: 6- and 12-month outcomes of a treatment approach for major depressive disorder in adults with type 2 diabetes.

Aims: To evaluate the long-term effects of behavioral treatments on glycemic and psychological outcomes for patients with major depressive disorder (MDD) and type 2 diabetes (T2D).

Methods: Program ACTIVE II was a multicenter randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), exercise (EXER), combination treatment (CBT + EXER) and usual care (UC) for adults with MDD and T2D.

Results: Primary outcomes: change in A1c and depressive symptoms at 6- (N = 87) and 12-months (N = 75) from baseline.

Community-Based Diabetes Awareness Strategy With Detection and Intervention: The Mobile Diabetes Education Center.

To prevent diabetes and increase equitable access to health care screenings, Touro University California has created and implemented a community outreach program called the Mobile Diabetes Education Center (MOBEC). This program is a joint effort that also involves Sutter Health, the California Department of Public Health, Kaiser Permanente, the Solano County Department of Public Health, and community-based organizations, focusing on advancing health equity in Solano County's at-risk populations. This article reports on the services and initial successes of MOBEC.

How do clinical researchers generate data-driven scientific hypotheses? Cognitive events using think-aloud protocol.

Objectives: This study aims to identify the cognitive events related to information use (e.g., "Analyze data", "Seek connection") during hypothesis generation among clinical researchers.

Optimized Management of Cardio-Renal-Metabolic (CRM) Conditions in Patients With T2D.

Describe cardio-renal-metabolic (CRM) conditions and their impact on health and patient-centered outcomes. Recognize current gaps in screening, risk factor management, and utilization of guideline-directed therapies in patients with CRM conditions. Select appropriate guideline-directed therapies for patients with type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and/or chronic kidney disease based on current guidelines and clinical evidence.

Data-driven hypothesis generation among inexperienced clinical researchers: A comparison of secondary data analyses with visualization (VIADS) and other tools.

Objectives: To compare how clinical researchers generate data-driven hypotheses with a visual interactive analytic tool (VIADS, a visual interactive analysis tool for filtering and summarizing large data sets coded with hierarchical terminologies) or other tools.

Methods: We recruited clinical researchers and separated them into "experienced" and "inexperienced" groups. Participants were randomly assigned to a VIADS or control group within the groups.

A Visual Analytic Tool (VIADS) to Assist the Hypothesis Generation Process in Clinical Research: Mixed Methods Usability Study.

Background: Visualization can be a powerful tool to comprehend data sets, especially when they can be represented via hierarchical structures. Enhanced comprehension can facilitate the development of scientific hypotheses. However, the inclusion of excessive data can make visualizations overwhelming.

Nonalcoholic fatty liver disease from a primary care perspective.

Nonalcoholic fatty liver disease (NAFLD) affects up to one-third of the US population. Approximately one-fifth of patients with NAFLD have nonalcoholic steatohepatitis (NASH), characterized by hepatocyte damage and inflammation with or without fibrosis. NASH leads to greater risk of liver-related complications and liver-related mortality, with the poorest outcomes seen in patients with advanced fibrosis.

Development, validation, and usage of metrics to evaluate the quality of clinical research hypotheses.

Objectives: Metrics and instruments can provide guidance for clinical researchers to assess their potential research projects at an early stage before significant investment. Furthermore, metrics can also provide structured criteria for peer reviewers to assess others' clinical research manuscripts or grant proposals. This study aimed to develop, test, validate, and use evaluation metrics and instruments to accurately, consistently, and conveniently assess the quality of scientific hypotheses for clinical research projects.

Conquering diabetes therapeutic inertia: practical tips for primary care.

Diabetes is a complex condition that is largely self-managed. Decades of scientific evidence has proved that early glycemic control leads to improved microvascular and macrovascular outcomes in people with diabetes mellitus. Despite well-established management guidelines, only about half of the patients with diabetes achieve glycemic targets, and only one in five patients achieve metabolic control (blood pressure, lipid, and glucose targets), and both patients and physicians find themselves stuck in a rut called therapeutic inertia (TI).

Preference for Type 2 Diabetes Therapies in the United States: A Discrete Choice Experiment.

Introduction: Type 2 diabetes mellitus (T2DM) is a chronic condition associated with substantial clinical and economic burden. As multiple therapeutic options are available, patient preferences on treatment characteristics are key in T2DM therapeutic decision-making. This study aimed to determine the preferences of US patients with T2DM for therapies recommended for first pharmacologic intensification after metformin.

The Roles of a Secondary Data Analytics Tool and Experience in Scientific Hypothesis Generation in Clinical Research: Protocol for a Mixed Methods Study.

Background: Scientific hypothesis generation is a critical step in scientific research that determines the direction and impact of any investigation. Despite its vital role, we have limited knowledge of the process itself, thus hindering our ability to address some critical questions.

Objective: This study aims to answer the following questions: To what extent can secondary data analytics tools facilitate the generation of scientific hypotheses during clinical research? Are the processes similar in developing clinical diagnoses during clinical practice and developing scientific hypotheses for clinical research projects? Furthermore, this study explores the process of scientific hypothesis generation in the context of clinical research.

Pharmacology-Insulin.

Insulin is an important treatment in diabetes, and understanding insulin pharmacokinetics is vital to clinical practice. The primary care physician should be knowledgeable about the decision for use, initiation of treatment and titration as well as common pitfalls such as hypoglycemia and cost.

Gestational diabetes: Optimizing Dx and management in primary care.

Understanding risk factors and glucose targets for gestational diabetes can help you identify at-risk patients and improve outcomes for mother and infant.

Associations between diabetes-related distress and predicted cardiovascular complication risks in patients with type 2 diabetes.

Context: Diabetes-related distress (DRD) is experienced by nearly 50% of people with diabetes at any given time in their diagnosis. The effects of low socioeconomic status (SES) and lacking access to resources can increase DRD. In addition, cardiovascular (CV) complications associated with diabetes are associated with higher DRD scores.