A Holistic Approach to the Measurement of Physical Function in Clinical Research.

Background: This commentary highlights the evolution of our understanding of physical function (PF) and key models/frameworks that have contributed to the current holistic understanding of PF, which encompasses not only a person's performance but also the environment and any adaptations an individual utilizes. This commentary also addresses how digital health tools can facilitate and complement the assessment of holistic PF and enable both objective and subjective input from the participant in their real-world environment. Lastly, we discuss how successful implementation of digital tools within clinical research requires patient input.

Identifying meaningful aspects of health and concepts of interest for assessment in systemic lupus erythematosus: implications for digital clinical measure development.

Objectives: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with heterogeneous clinical manifestations which significantly impacts the daily lives of patients. Herein, we aimed to (i) investigate patients' perspectives on and experience with SLE; (ii) identify meaningful aspects of health (MAHs) and concepts of interest (COIs) in SLE that could be evaluated using digital clinical measures (DCMs); and (iii) identify target DCMs for their assessment.

Methods: A mixed-methods, multistep approach was deployed for (i) exploring patients' experience with SLE through a social media listening study and focused group discussions with patients; (ii) mapping patients' experiences to define MAHs and identify COIs measurable using DCMs; (iii) selecting DCMs for the target COIs; and (iv) identifying types of wearable sensors for measuring COIs in the patients.

The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease.

Background: Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD.

Do Measures of Real-World Physical Behavior Provide Insights Into the Well-Being and Physical Function of Cancer Survivors? Cross-Sectional Analysis.

Background: As the number of cancer survivors increases, maintaining health-related quality of life in cancer survivorship is a priority. This necessitates accurate and reliable methods to assess how cancer survivors are feeling and functioning. Real-world digital measures derived from wearable sensors offer potential for monitoring well-being and physical function in cancer survivorship, but questions surrounding the clinical utility of these measures remain to be answered.

Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance.

Digital health technologies (DHTs) have the potential to modernize drug development and clinical trial operations by remotely, passively, and continuously collecting ecologically valid evidence that is meaningful to patients' lived experiences. Such evidence holds potential for all drug development stakeholders, including regulatory agencies, as it will help create a stronger evidentiary link between approval of new therapeutics and the ultimate aim of improving patient lives. However, only a very small number of novel digital measures have matured from exploratory usage into regulatory qualification or efficacy endpoints.

The Case for the Patient-Centric Development of Novel Digital Sleep Assessment Tools in Major Depressive Disorder.

Background: Depression imposes a major burden on public health as the leading cause of disability worldwide. Sleep disturbance is a core symptom of depression that affects the vast majority of patients. Nonetheless, it is frequently not resolved by depression treatment and may even be worsened through some pharmaceutical interventions.

Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior.

Purpose: The burden of cancer cachexia on patients' health-related quality of life, specifically their physical functioning, is well documented, but clinical trials thus far have failed to show meaningful improvement in physical functioning. The purpose of this review is to summarize existing methods of assessing physical function in cancer cachexia, outline a path forward for measuring what is meaningful to patients using digital measures derived from digital health technologies (DHTs), and discuss the current landscape of digital measures from the clinical and regulatory standpoint.

Design: For this narrative review, peer-reviewed articles were searched on PubMed, clinical trials records were searched on clinicaltrials.

An intervention to decrease sedentary behavior in older adults: A secondary analysis of a randomized controlled trial.

Background: Sedentary behaviors are associated with adverse health outcomes in older adults. The feasibility of behavioral interventions in this population is unclear.

Methods: In the Sit Less, Interact, Move More (SLIMM) trial of 106 participants who had obesity, those randomized to the SLIMM intervention ( = 54) were instructed to replace sedentary activities with stepping.

Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer's Disease Drug Development.

Alzheimer's disease (AD) is a devastating neurodegenerative disease and the primary cause of dementia worldwide. Despite the magnitude of AD's impact on patients, caregivers, and society, nearly all AD clinical trials fail. A potential contributor to this high rate of failure is that established clinical outcome assessments fail to capture subtle clinical changes, entail high burden for patients and their caregivers, and ineffectively address the aspects of health deemed important by patients and their caregivers.

Predicting hospitalization from real-world measures in patients with chronic kidney disease: A proof-of-principle study.

Objective: To investigate if in-clinic measures of physical function and real-world measures of physical behavior and mobility effort are associated with one another and to determine if they predict future hospitalization in participants with chronic kidney disease (CKD).

Methods: In this secondary analysis, novel real-world measures of physical behavior and mobility effort, including the best 6-minute step count (B6SC), were derived from passively collected data from a thigh worn actigraphy sensor and compared to traditional in-clinic measures of physical function (e.g.

Reverse Engineering of Digital Measures: Inviting Patients to the Conversation.

Background: Digital measures offer an unparalleled opportunity to create a more holistic picture of how people who are patients behave in their real-world environments, thereby establishing a better connection between patients, caregivers, and the clinical evidence used to drive drug development and disease management. Reaching this vision will require achieving a new level of co-creation between the stakeholders who design, develop, use, and make decisions using evidence from digital measures.

Summary: In September 2022, the second in a series of meetings hosted by the Swiss Federal Institute of Technology in Zürich, the Foundation for the National Institutes of Health Biomarkers Consortium, and sponsored by Wellcome Trust, entitled "Reverse Engineering of Digital Measures," was held in Zurich, Switzerland, with a broad range of stakeholders sharing their experience across four case studies to examine how patient centricity is essential in shaping development and validation of digital evidence generation tools.

Sensors for Human Physical Behaviour Monitoring.

The understanding and measurement of physical behaviours that occur in everyday life are essential not only for determining their relationship with health, but also for interventions, physical activity monitoring/surveillance of the population and specific groups, drug development, and developing public health guidelines and messages [...

Reallocating Time to Physical Activity and Sleep: Associations with Body Mass Index in Cancer Survivors.

Background: Body mass index (BMI) above ≥ 25 kg/m is associated with increased risk for cancer-related morbidity and mortality. Achieving recommended amounts of physical activity (PA), sedentary time (ST), and sleep can help cancer survivors (CS) attain a healthy BMI. This cross-sectional study examined the potential role of reallocating time between moderate and light PA, ST, and sleep on BMI in CS.

An Evaluation of Participant Perspectives and Wear-Time Compliance for a Wrist-Worn Versus Thigh-Worn Accelerometer in Cancer Survivors.

Background: Accelerometers are frequently used to measure free-living physical activity and sleep in cancer survivors. To obtain valid data, participants must adhere to wear-time guidelines; therefore, understanding survivor's preference may be critical when selecting an accelerometer. This study compared cancer survivors' reported discomfort and interference, and wear-time compliance between a wrist-worn accelerometer and a thigh-worn accelerometer.

Reallocating time to physical activity and sleep: associations with quality of life in cancer survivors.

Purpose: Quality of life (QOL) is an important psychosocial outcome in cancer survivors (CS). Physical activity (PA), reducing sedentary time (ST), and sleep can help CS improve QOL; however, these behaviors are commonly studied in isolation, despite their interdependence during the 24-h day (i.e.

Physical Activity and Stool Metabolite Relationships Among Adults at High Risk for Colorectal Cancer.

Background: Adenomatous polyps are associated with an increased risk of developing colorectal cancer. Physical activity (PA) and spending less time sedentary may reduce risk of polyp recurrence and cancer incidence. This study examined associations between PA, sedentary time, and stool metabolites in adults at high risk for developing colorectal cancer.

Establishing a Global Standard for Wearable Devices in Sport and Exercise Medicine: Perspectives from Academic and Industry Stakeholders.

Millions of consumer sport and fitness wearables (CSFWs) are used worldwide, and millions of datapoints are generated by each device. Moreover, these numbers are rapidly growing, and they contain a heterogeneity of devices, data types, and contexts for data collection. Companies and consumers would benefit from guiding standards on device quality and data formats.

Temporal patterns of physical activity in successful weight loss maintainers.

Background/objectives: Individuals successful at weight loss maintenance engage in high amounts of physical activity (PA). Understanding how and when weight loss maintainers accumulate PA within a day and across the week may inform PA promotion strategies and recommendations for weight management.

Methods: We compared patterns of PA in a cohort of weight loss maintainers (WLM, n = 28, maintaining ≥13.

Targeting Sedentary Behavior in CKD: A Pilot and Feasibility Randomized Controlled Trial.

Background And Objectives: We tested the feasibility of reducing sedentary behavior common in CKD.

Design, Setting, Participants, & Measurements: We carried out a Sit Less, Interact, Move More intervention in a 24-week parallel-group, randomized controlled trial in patients with stages 2-5 CKD. In the intervention group (=54), accelerometry performed at baseline and repeated every 4 weeks was used to develop and monitor adherence to individualized plans targeting sedentary and stepping durations.

A Framework to Evaluate Devices That Assess Physical Behavior.

Body-worn devices that estimate physical behavior have tremendous potential to address key research gaps. However, there is no consensus on how devices and processing methods should be developed and evaluated, resulting in large differences in summary estimates and confusion for end users. We propose a phase-based framework for developing and evaluating devices that emphasizes robust validation studies in naturalistic conditions.

Elevated insulin levels following 7 days of increased sedentary time are due to lower hepatic extraction and not higher insulin secretion.

Higher insulin following sedentary behavior may be due to increased insulin secretion (IS), decreased hepatic insulin extraction (HIE), or a combination of both. Ten healthy adults completed glucose tolerance tests following 7 days of normal activity and 7 days of increased sitting. There were no differences in IS; however, HIE at 120 min after ingestion (85.

Older women's perceptions of wearable and smart home activity sensors.

: The aim of this study was to characterize perceptions of wearable and smart home technologies of older women using semi-structured interviews.: Participants (n = 10) were shown two wearable sensors and a smart home sensor. All participants were 60 years of age or older with the exception of one participant (ages: 57-70,average age: 64.

Physical Activity Energy Expenditure and Total Daily Energy Expenditure in Successful Weight Loss Maintainers.

Objective: The objective of this study was to compare physical activity energy expenditure (PAEE) and total daily energy expenditure (TDEE) in successful weight loss maintainers (WLM) with normal weight controls (NC) and controls with overweight/obesity (OC).

Methods: Participants were recruited in three groups: WLM (n = 25, BMI 24.1 ± 2.