The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study.

BACKGROUND: Little is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement. OBJECTIVE: To answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19? DESIGN: We conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants' experiences with the impact of COVID-19 on research engagement. PARTICIPANTS: Seven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript. APPROACH: We used a content analysis approach and identified the main themes using an inductive process. KEY RESULTS: Respondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity. CONCLUSIONS: COVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement. TRIAL REGISTRATION: Clinicaltrials.gov NCT02722382.

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

We 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. Background This 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. Methods This 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. Results Patients 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. Conclusions The 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 registration NCT02722382 .

A case-control study examining whether neurological deficits and PTSD in combat veterans are related to episodes of mild TBI.

BACKGROUND: Mild traumatic brain injury (mTBI) is a common injury among military personnel serving in Iraq or Afghanistan. The impact of repeated episodes of combat mTBI is unknown. OBJECTIVE: To evaluate relationships among mTBI, post-traumatic stress disorder (PTSD) and neurological deficits (NDs) in US veterans who served in Iraq or Afghanistan. METHODS: This was a case-control study. From 2091 veterans screened for traumatic brain injury, the authors studied 126 who sustained mTBI with one or more episodes of loss of consciousness (LOC) in combat. Comparison groups: 21 combat veterans who had definite or possible episodes of mTBI without LOC and 21 veterans who sustained mTBI with LOC as civilians. RESULTS: Among combat veterans with mTBI, 52% had NDs, 66% had PTSD and 50% had PTSD and an ND. Impaired olfaction was the most common ND, found in 65 veterans. The prevalence of an ND or PTSD correlated with the number of mTBI exposures with LOC. The prevalence of an ND or PTSD was >90% for more than five episodes of LOC. Severity of PTSD and impairment of olfaction increased with number of LOC episodes. The prevalence of an ND for the 34 combat veterans with one episode of LOC (4/34=11.8%) was similar to that of the 21 veterans of similar age and educational background who sustained civilian mTBI with one episode of LOC (2/21=9.5%, p-NS). CONCLUSIONS: Impaired olfaction was the most frequently recognised ND. Repeated episodes of combat mTBI were associated with increased likelihood of PTSD and an ND. Combat setting may not increase the likelihood of an ND. Two possible connections between mTBI and PTSD are (1) that circumstances leading to combat mTBI likely involve severe psychological trauma and (2) that altered cerebral functioning following mTBI may increase the likelihood that a traumatic event results in PTSD.

For veterans with mild traumatic brain injury, improved posttraumatic stress disorder severity and sleep correlated with symptomatic improvement.

This was an observational study of a cohort of 63 Operation Iraqi Freedom/Operation Enduring Freedom veterans with mild traumatic brain injury (mTBI) associated with an explosion. They had headaches, residual neurological deficits (NDs) on neurological examination, and posttraumatic stress disorder (PTSD) and were seen on average 2.5 years after their last mTBI. We treated them with sleep hygiene counseling and oral prazosin. We monitored headache severity, daytime sleepiness using the Epworth Sleepiness Scale, cognitive performance using the Montreal Cognitive Assessment test, and the presence of NDs. We quantitatively measured olfaction and assessed PTSD severity using the PTSD Checklist-Military Version. Nine weeks after starting sleep counseling and bedtime prazosin, the veterans' headache severity decreased, cognitive function as assayed with a brief screening tool improved, and daytime sleepiness diminished. Six months after completing treatment, the veterans demonstrated additional improvement in headache severity and daytime sleepiness and their improvements in cognitive function persisted. There were no changes in the prevalence of NDs or olfaction scores. Clinical improvements correlated with reduced PTSD severity and daytime sleepiness. The data suggested that reduced clinical manifestations following mTBI correlated with PTSD severity and improvement in sleep, but not the presence of NDs or olfaction impairment.

Relationships between mild traumatic brain injury sustained in combat and post-traumatic stress disorder.

The setting of the trauma is a distinguishing feature between mild traumatic brain injury (mTBI; also called concussion) that occurs in civilian settings compared with that occurring in combat. Combat mTBI is frequently associated with a prolonged stress reaction, post-traumatic stress disorder (PTSD). Individuals with mTBI and PTSD from combat in Operations Iraqi Freedom and Enduring Freedom often develop prolonged post-concussion symptoms (PCSs) such as headache. Both mTBI and PTSD may contribute to PCSs. PTSD may worsen and prolong the PCSs following mTBI by disrupting sleep. It is not known how mTBI predisposes an individual to develop PTSD.

Improving sleep: initial headache treatment in OIF/OEF veterans with blast-induced mild traumatic brain injury.

This was an observational study of a cohort of 126 veterans with mild traumatic brain injury caused by an explosion during deployment in Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF); 74 of the 126 veterans had comorbidities including frequent, severe headaches and residual deficits on neurological examination, neuropsychological testing, or both. Of these veterans, 71 had posttraumatic stress disorder and only 5 had restful sleep. We examined whether treatment with sleep hygiene counseling and oral prazosin would improve sleep, headaches, and cognitive performance. Nine weeks after providing sleep counseling and initiating an increasing dosage schedule of prazosin at bedtime, 65 veterans reported restful sleep. Peak headache pain (0-10 scale) decreased from 7.28 +/- 0.27 to 4.08 +/- 0.19 (values presented as mean +/- standard deviation). The number of headaches per month decreased from 12.40 +/- 0.94 to 4.77 +/- 0.34. Montreal Cognitive Assessment scores improved from 24.50 +/- 0.49 to 28.60 +/- 0.59. We found these gains maintained 6 months later. This pilot study suggests that addressing sleep is a good first step in treating posttraumatic headaches in OIF/OEF veterans.

Headaches among Operation Iraqi Freedom/Operation Enduring Freedom veterans with mild traumatic brain injury associated with exposures to explosions.

Traumatic brain injury (TBI) is a common injury type among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans, and headaches are a frequent consequence of TBI. We examined the hypothesis that among veterans who reported mild TBI caused by exposure to an explosion during deployment in OIF/OEF, those with residual neurocognitive deficits would have a higher frequency of headaches and more severe headaches. We evaluated 155 consecutive veterans with neurological examination and neuropsychological testing. We excluded 29 veterans because they did not have mild TBI or they did not complete the evaluation. We analyzed headache pattern, intensity, and frequency. Among the 126 veterans studied, 80 had impairments on neurological examination or neuropsychological testing that were best attributed to TBI. Veterans with impairments had been exposed to more explosions and were more likely to have headache, features of migraine, more severe pain, more frequent headaches, posttraumatic stress disorder, and impaired sleep with nightmares.

Directed rehabilitation reduces pain and depression while increasing independence and satisfaction with life for patients with paraplegia due to epidural metastatic spinal cord compression.

We determined whether directed rehabilitation affected survival, pain, depression, independence, and satisfaction with life for veterans who were nonambulatory after spinal epidural metastasis (SEM) treatment. We compared 12 consecutive paraplegic veterans who received 2 weeks of directed rehabilitation with a historical control group of 30 paraplegic veterans who did not receive rehabilitation. The rehabilitation program emphasized transfers, bowel and bladder care, incentive spirometry, nutrition, and skin care. The outcome measures were survival, independence, pain levels, depression, and satisfaction with life. Patients receiving rehabilitation had longer median survivals, fewer deaths from myelopathic complications, less pain 2 weeks after SEM treatment, lower depression scores, and higher satisfaction with life scores. In addition, among the patients who received rehabilitation, eight became independent for transfers (vs zero controls) and nine returned home (vs six controls). We conclude that directed rehabilitation reduced patients' pain levels and increased their mobility, survival, and life satisfaction.

Persistent benefits of rehabilitation on pain and life quality for nonambulatory patients with spinal epidural metastasis.

We determined whether the benefits of directed rehabilitation for pain, depression, and satisfaction with life persisted for veterans who were nonambulatory after spinal epidural metastasis (SEM) treatment. Twelve consecutive veterans (paraplegic after SEM treatment) who received 2 weeks of directed rehabilitation were compared with a historical control group of thirty paraplegic veterans who did not receive rehabilitation. Subjects were followed until death. Pain levels, depression, satisfaction with life, and consumption of pain medication were measured. Subjects who received rehabilitation had less pain, consumed less pain medication, were less depressed, and had higher satisfaction with life. The benefits to the rehabilitated subjects persisted until their deaths. We conclude that spinal cord injury rehabilitation for nonambulatory subjects with SEM produces persistent benefits for pain, depression, and satisfaction with life.