The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: Digital health definitions are abundant, but often lack clarity and precision. We aimed to develop a minimum information framework to define patient-facing digital health interventions (DHIs) for outcomes research. METHODS: Definitions of digital-health-related terms (DHTs) were systematically reviewed, followed by a content analysis using frameworks, including PICOTS (population, intervention, comparator, outcome, timing, and setting), Shannon-Weaver Model of Communication, Agency for Healthcare Research and Quality Measures, and the World Health Organization's Classification of Digital Health Interventions. Subsequently, we conducted an online Delphi study to establish a minimum information framework, which was pilot tested by 5 experts using hypothetical examples. RESULTS: After screening 2610 records and 545 full-text articles, we identified 101 unique definitions of 67 secondary DHTs in 76 articles, resulting in 95 different patterns of concepts among the definitions. World Health Organization system (84.5%), message (75.7%), intervention (58.3%), and technology (52.4%) were the most frequently covered concepts. For the Delphi survey, we invited 47 members of the ISPOR Digital Health Special Interest Group, 18 of whom became the Delphi panel. The first, second, and third survey rounds were completed by 18, 11, and 10 respondents, respectively. After consolidating results, the PICOTS-ComTeC acronym emerged, involving 9 domains (population, intervention, comparator, outcome, timing, setting, communication, technology, and context) and 32 optional subcategories. CONCLUSIONS: Patient-facing DHIs can be specified using PICOTS-ComTeC that facilitates identification of appropriate interventions and comparators for a given decision. PICOTS-ComTeC is a flexible and versatile tool, intended to assist authors in designing and reporting primary studies and evidence syntheses, yielding actionable results for clinicians and other decision makers.

Detecting Variation in Clinical Practice Patterns for Geriatric Trauma Care Using Social Network Analysis.

OBJECTIVE: To characterize hospital-level professional networks of physicians caring for older trauma patients as a function of trauma patient age distribution. BACKGROUND: The causal factors associated with between-hospital variation in geriatric trauma outcomes are poorly understood. Variation in physician practice patterns reflected by differences in professional networks might contribute to hospital-level differences in outcomes for older trauma patients. METHODS: This is a population-based, cross-sectional study of injured older adults (age 65 or above) and their physicians from January 1, 2014, to December 31, 2015, using Health Care Cost and Utilization Project inpatient data and Medicare claims from 158 hospitals in Florida. We used social network analyses to characterize the hospitals in terms of network density, cohesion, small-worldness, and heterogeneity, then used bivariate statistics to assess the relationship between network characteristics and hospital-level proportion of trauma patients who were aged 65 or above. RESULTS: We identified 107,713 older trauma patients and 169,282 patient-physician dyads. The hospital-level proportion of trauma patients who were aged 65 or above ranged from 21.5% to 89.1%. Network density, cohesion, and small-worldness in physician networks were positively correlated with hospital geriatric trauma proportions ( R =0.29, P <0.001; R =0.16, P =0.048; and R =0.19, P <0.001, respectively). Network heterogeneity was negatively correlated with geriatric trauma proportion ( R =0.40, P <0.001). CONCLUSIONS: Characteristics of professional networks among physicians caring for injured older adults are associated with the hospital-level proportion of trauma patients who are older, indicating differences in practice patterns at hospitals with older trauma populations. Associations between interspecialty collaboration and patient outcomes should be explored as an opportunity to improve the treatment of injured older adults.

Postdischarge Caregiver Burden Among Family Caregivers of Older Trauma Patients.

Importance: Caregiver burden, characterized by psychological distress and physical morbidity, affects more than 50 million family caregivers of older adults in the United States. Risk factors for caregiver burden among caregivers of older trauma patients have not been well characterized. Objective: To characterize postdischarge caregiver burden among caregivers of older trauma patients and identify targets that can inform interventions to improve their experience. Design, Setting, and Participants: This study used a repeated cross-sectional design. Participants were family caregivers for adults 65 years or older with traumatic injury who were discharged from 1 of 2 level I trauma centers. Telephone interviews were conducted at 1 month and 3 months postdischarge with family caregivers (identified by the patient as family or friends who provided unpaid care). Admissions occurred between December 2019 and May 2021, and data were analyzed from June 2021 to May 2022. Exposure: Hospital admission for geriatric trauma. Main Outcome and Measures: High caregiver burden was defined by a score of 17 or higher on the 12-item Zarit Burden Interview. Caregiver self-efficacy and preparedness for caregiving were assessed via the Revised Scale for Caregiving Self-Efficacy and Preparedness for Caregiving Scale, respectively. Associations between caregiver self-efficacy, preparedness for caregiving, and caregiver burden were tested via mixed-effect logistic regression. Results: There were 154 family caregivers enrolled in the study. Their mean (SD) age was 60.6 (13.0) years (range, 18-92 years), 108 of 154 were female (70.6%). The proportion of caregivers experiencing high burden (Zarit Burden Interview score ≥17) was unchanged over time (1 month, 38 caregivers [30.9%]; 3 months, 37 caregivers [31.4%]). Participants with lower caregiver self-efficacy and preparedness for caregiving were more likely to experience greater caregiver burden (odds ratio [OR], 7.79; 95% CI, 2.54-23.82; P < .001; and OR, 5.76; 95% CI, 1.86-17.88; P = .003, respectively). Conclusion and Relevance: This study found that nearly a third of family caregivers of older trauma patients experience high caregiver burden up to 3 months after the patients' discharge. Targeted interventions to increase caregiver self-efficacy and preparedness may reduce caregiver burden in geriatric trauma.

The Trauma Dyad: The Role of Informal Caregivers for Older Adults After Traumatic Injury.

OBJECTIVE: To investigate the association between higher injury severity and increased informal caregiving received by injured older adults. SUMMARY OF BACKGROUND DATA: Injured older adults experience high rates of functional decline and disability after hospitalization. Little is known about the scope of caregiving received post-discharge, particularly from informal caregivers such as family. METHODS: We used the National Health and Aging Trends Study 2011 to 2018 linked to Medicare claims to identify adults ≥65 with hospital admission for traumatic injury and a National Health and Aging Trends Study interview within 12 months pre- and post-trauma. Injury severity was assessed using the injury severity score (ISS, low 0-9; moderate 10-15; severe 16-75). Patients reported the types and hours of formal and informal help received and any unmet care needs. Multi variable logistic regression models examined the association between ISS and increase in informal caregiving hours after discharge. RESULTS: We identified 430 trauma patients. Most were female (67.7%), non-Hispanic White (83.4%) and half were frail. The most common mechanism of injury was fall (80.8%) and median injury severity was low (ISS = 9). Those reporting receiving help with any activity increased post-trauma (49.0% to 72.4%, P < 0.01), and unmet needs nearly doubled (22.8% to 43.0%, P < 0.01). Patients had a median of 2 caregivers and most (75.6%) were informal, often family members. Median weekly hours of care received pre- versus post-injury increased from 8 to 14 (P < 0.01). ISS did not independently predict increase in caregiving hours; pre-trauma frailty predicted an increase in hours ≥8 per week. CONCLUSIONS: Injured older adults reported high baseline care needs which increased significantly after hospital discharge and were mostly met by informal caregivers. Injury was associated with increased need for assistance and unmet needs regardless of injury severity. These results can help set expectations for caregivers and facilitate post-acute care transitions.

Surgeon-reported Factors Influencing Adoption of Quality Standards for Goal-concordant Care in Patients With Advanced Cancer: A Qualitative Study.

OBJECTIVE: This study explored surgical oncologists' perspectives on factors influencing adoption of quality standards in patients with advanced cancer. BACKGROUND: The American College of Surgeons Geriatric Surgery Verification Program includes communication standards designed to facilitate goal-concordant care, yet little is known about how surgeons believe these standards align with clinical practice. METHODS: Semistructured video-based interviews were conducted from November 2020 to January 2021 with academic surgical oncologists purposively sampled based on demographics, region, palliative care certification, and years in practice. Interviews addressed: (1) adherence to standards documenting care preferences for life-sustaining treatment, surrogate decision-maker, and goals of surgery; and (2) factors influencing their adoption into practice. Interviews were audio-recorded, transcribed, qualitatively analyzed, and conducted until thematic saturation was reached. RESULTS: Twenty-six surgeons participated (57.7% male, 8.5 mean years in practice, 19.2% palliative care board-certified). Surgeons reported low adherence to documenting care preferences and surrogate decision-maker and high adherence to discussing, but not documenting, goals of surgery. Participants held conflicting views about the relevance of care preferences to preoperative conversations and surrogate decision-maker documentation by the surgeon and questioned the direct connection between documentation of quality standards and higher value patient care. Key themes regarding factors influencing adoption of quality standards included organizational culture, workflow, and multidisciplinary collaboration. CONCLUSIONS: Although surgeons routinely discuss goals of surgery, documentation is inconsistent; care preferences and surrogate decision-makers are rarely discussed or documented. Adherence to these standards would be facilitated by multidisciplinary collaboration, institutional standardization, and evidence linking standards to higher value care.

Stress-Related Disorders of Family Members of Patients Admitted to the Intensive Care Unit With COVID-19.

Importance: The psychological symptoms associated with having a family member admitted to the intensive care unit (ICU) during the COVID-19 pandemic are not well defined. Objective: To examine the prevalence of symptoms of stress-related disorders, primarily posttraumatic stress disorder (PTSD), in family members of patients admitted to the ICU with COVID-19 approximately 90 days after admission. Design, Setting, and Participants: This prospective, multisite, mixed-methods observational cohort study assessed 330 family members of patients admitted to the ICU (except in New York City, which had a random sample of 25% of all admitted patients per month) between February 1 and July 31, 2020, at 8 academic-affiliated and 4 community-based hospitals in 5 US states. Exposure: Having a family member in the ICU with COVID-19. Main Outcomes and Measures: Symptoms of PTSD at 3 months, as defined by a score of 10 or higher on the Impact of Events Scale 6 (IES-6). Results: A total of 330 participants (mean [SD] age, 51.2 [15.1] years; 228 [69.1%] women; 150 [52.8%] White; 92 [29.8%] Hispanic) were surveyed at the 3-month time point. Most individuals were the patients' child (129 [40.6%]) or spouse or partner (81 [25.5%]). The mean (SD) IES-6 score at 3 months was 11.9 (6.1), with 201 of 316 respondents (63.6%) having scores of 10 or higher, indicating significant symptoms of PTSD. Female participants had an adjusted mean IES-6 score of 2.6 points higher (95% CI, 1.4-3.8; P < .001) than male participants, whereas Hispanic participants scored a mean of 2.7 points higher compared with non-Hispanic participants (95% CI, 1.0-4.3; P = .002). Those with graduate school experience had an adjusted mean score of 3.3 points lower (95% CI, 1.5-5.1; P < .001) compared with those with up to a high school degree or equivalent. Qualitative analyses found no substantive differences in the emotional or communication-related experiences between those with high vs low PTSD scores, but those with higher scores exhibited more distrust of practitioners. Conclusions and Relevance: In this cohort study, symptoms of PTSD among family members of ICU patients with COVID-19 were high. Hispanic ethnicity and female gender were associated with higher symptoms. Those with higher scores reported more distrust of practitioners.

Reliability, validity and important difference estimates for the NCCN-FACT Ovarian Symptom Index-18 (NFOSI-18).

Objective: To evaluate psychometric performance of the NCCN-FACT Ovarian Cancer Symptom Index-18 (NFOSI-18) in advanced ovarian cancer. Methods: Cross-sectional, observational data from patients receiving treatment for ovarian cancer. Other measures included European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core (EORTC QLQ-C30) and associated ovarian cancer module (EORTC QLQ-OV28) and Work Productivity and Activity Impairment. Internal consistency reliability, construct validity and anchor-based clinically important differences were assessed. Results: 897 patients were analyzed. Reliability was acceptable for all NFOSI-18 scores; construct validity was supported. Twelve anchors sufficiently correlated with NFOSI-18 scores and suggested clinically important differences: NFOSI-18 total score (5-7), disease-related symptoms - physical (3-4), disease-related symptoms - emotional (1), treatment side effects (2) and functional well-being (1-2). Conclusions: Results provide evidence of reliability and validity of NFOSI-18 scores. Generated CIDs will help improve interpretation of between-group treatment differences in clinical trials.

Lay abstract The National Comprehensive Cancer Network Functional Assessment of Cancer Therapy ­ Ovarian Cancer Symptom Index-18 (NFOSI-18) is a questionnaire assessing the health of patients with ovarian cancer. When using such questionnaires, it is important to evidence that they produce consistent scores (referred to as reliability) and are aligned with other assessments of health (referred to as construct validity). It is also important to set guidelines on what constitutes a clinically important difference in scores, so clinicians and researchers can judge how effective new treatments are. This study analyzed data from 897 patients with advanced ovarian cancer, providing evidence of reliability and construct validity. Guidelines for clinically important differences were also provided. The findings support continued use of the NFOSI-18.

Cancer in the Shadow of COVID: Early-Stage Breast and Prostate Cancer Patient Perspectives on Surgical Delays Due to COVID-19.

BACKGROUND: During the height of the coronavirus disease 2019 (COVID-19) pandemic, elective surgeries, including oncologic surgeries, were delayed. Little prospective data existed to guide practice, and professional surgical societies issued recommendations grounded mainly in common sense and expert consensus, such as medical therapy for early-stage breast and prostate cancer patients. To understand the patient experience of delay in cancer surgery during the pandemic, we interviewed breast and prostate cancer patients whose surgeries were delayed due to the pandemic. PATIENTS AND METHODS: Patients with early-stage breast or prostate cancer who suffered surgical postponement at Brigham and Women's Hospital (BWH) were invited to participate. Semi-structured telephone interviews were conducted with 21 breast and prostate cancer patients. Interviews were transcribed, and qualitative analysis using ground-theory approach was performed. RESULTS: Most patients reported significant distress due to cancer and COVID. Key themes that emerged included the lack of surprise and acceptance of the surgical delays but endorsed persistent cancer- and delay-related worries. Satisfaction with patient-physician communication and the availability of a delay strategy were key factors in patients' acceptance of the situation; perceived lack of communication prompted a few patients to seek care elsewhere. DISCUSSION: The clinical effect of delay in cancer surgery will take years to fully understand, but there are immediate steps that can be taken to improve the patient experience of delays in care, including elicitation of individual patient perspectives and ongoing communication. More work is needed to understand the wider experiences of patients, especially minority, socioeconomically disadvantaged, and uninsured patients, who encounter delays in oncologic care.

A novel patient-reported outcomes instrument assessing the side effects of peanut oral immunotherapy.

BACKGROUND: Patients treated with peanut oral immunotherapy (OIT) may experience adverse reactions, particularly during up-dosing. OBJECTIVE: To develop the Side Effects of Peanut Oral Immunotherapy Diary (SEPOD), an electronic questionnaire assessing the daily side effects of peanut OIT in clinical trials. METHODS: Content and design of the SEPOD were informed by empirical literature review and meetings with 3 allergy-immunology experts. Interviews to confirm content and inform revisions were conducted in 24 pediatric patients with peanut allergy (14 treated with peanut OIT) aged 6 to 17 years; children aged 6 to 11 years were interviewed with their caregiver. RESULTS: The SEPOD was drafted after literature review and expert interviews; the initial measurement approach comprised 2 SEPOD versions, a patient-reported outcome (PRO) version for children aged 12 to 17 years, and a caregiver-administered PRO version for children aged 6 to 11 years with instructions for caregiver questionnaire administration. Pediatric patients were expected to respond independently on both versions. Patient interviews indicated that some younger children (ie, aged 6-8 years) had difficulty understanding questions, even when reading aloud; therefore, a caregiver-administered outcome version, identical in content to the caregiver-administered PRO version, was developed for this age group. The final electronic SEPOD covered 23 peanut OIT side effects within the following 7 domains: gastrointestinal, dermatologic, itching, nasal, and respiratory, swelling (eyelid or periorbital, lip, tongue, and throat), pain (tongue, mouth, and throat), and dizziness. CONCLUSION: This study yielded the SEPOD, a new clinical outcome assessment instrument with various methods of administration that can be used to assess the side effects of peanut OIT experienced by pediatric patients in a clinical trial setting.

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures.

BACKGROUND: Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development. METHODS: A concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions. RESULTS: A full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n = 23 pediatric patients, n = 13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n = 31 pediatric patients, n = 48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8-17 years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6 months to 17 years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale. CONCLUSIONS: This research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

Development and Psychometric Evaluation of the Life Interference Questionnaire for Growth Hormone Deficiency (LIQ-GHD) to Assess Growth Hormone Injection Burden in Children and Adults.

BACKGROUND: Current recombinant human growth hormone (r-hGH) replacement therapy involves long-term daily subcutaneous injections to treat growth hormone deficiency (GHD) in children and adults. Daily r-hGH injections can be burdensome, often resulting in poor treatment compliance. Clinical outcome assessments (COAs) can capture the burden of these injections from the patient (and caregiver) perspective and may demonstrate the benefit of a less-frequent r-hGH injection regimen, which may ultimately improve treatment compliance and long-term outcomes. OBJECTIVE: To address this knowledge gap, qualitative research was conducted to inform the development of a new Life Interference Questionnaire for Growth Hormone Deficiency (LIQ-GHD), designed to measure the experiences of patients taking r-hGH GHD injections. A second objective was to evaluate the hypothesized factor structure and preliminary performance of the LIQ-GHD in a cross-sectional observational study. METHODS: An empirical literature review and expert advice meetings were conducted to inform development of the draft LIQ-GHD (pediatric and adult versions). In-person concept elicitation and cognitive debriefing interviews were conducted with GHD patients (and patient dyads including caregivers) to explore and confirm concept coverage and evaluate respondents' ability to understand the questionnaire. The draft LIQ-GHD was then tested in a cross-sectional field study involving pediatric and adult patients receiving daily r-hGH injections for GHD. The factor structure, reliability, and validity were analyzed for the overall sample and for pediatric, adolescent, and adult subgroups. RESULTS: Results from the literature review and input from six experts were used to develop and refine the LIQ-GHD, with content covering pen ease of use; regimen convenience; life interference due to regimen; benefit/satisfaction/willingness to continue treatment; regimen choice/preference; intent to comply with regimen; injection-related signs/symptoms; and reasons for missed injections. Twenty-one patient interviews confirmed comprehensive concept coverage and patient/caregiver comprehension of the LIQ-GHD. A total of 224 patients (n = 70 children/caregiver dyads, n = 79 adolescents/caregiver dyads, n = 75 adults) participated in the field study. While most items showed floor effects, confirmatory factor analysis fit statistics were good for the overall sample (root mean square error of approximation = 0.07, comparative fit index = 0.98) and for the full pediatric sample after dropping co-dependent questions from the model. Cronbach's alpha (α) ranged from 0.746 to 0.905 and intra-class correlation coefficients ranged from 0.761 to 0.918 for the overall sample on LIQ-GHD domains. Scores correlated as predicted with an existing criterion measure in the overall sample and LIQ-GHD domain scores distinguished known groups as expected. CONCLUSIONS: The LIQ-GHD is a new COA for the measurement of r-hGH injection treatment burden. This research provides evidence supporting its content validity, hypothesized factor structure, score reliability, and construct validity in pediatric and adult populations.