Participant Engagement and Adherence to Providing Smartwatch and Patient-Reported Outcome Data: Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Real-World Study.

BACKGROUND: Digital health studies using electronic patient-reported outcomes (ePROs) and wearables bring new challenges, including the need for participants to consistently provide trial data. OBJECTIVE: This study aims to characterize the engagement, protocol adherence, and data completeness among participants with rheumatoid arthritis enrolled in the Digital Tracking of Arthritis Longitudinally (DIGITAL) study. METHODS: Participants were invited to participate in this app-based study, which included a 14-day run-in and an 84-day main study. In the run-in period, data were collected via the ArthritisPower mobile app to increase app familiarity and identify the individuals who were motivated to participate. Successful completers of the run-in period were mailed a wearable smartwatch, and automated and manual prompts were sent to participants, reminding them to complete app input or regularly wear and synchronize devices, respectively, during the main study. Study coordinators monitored participant data and contacted participants via email, SMS text messaging, and phone to resolve adherence issues per a priori rules, in which consecutive spans of missing data triggered participant contact. Adherence to data collection during the main study period was defined as providing requested data for >70% of 84 days (daily ePRO, ≥80% daily smartwatch data) or at least 9 of 12 weeks (weekly ePRO). RESULTS: Of the 470 participants expressing initial interest, 278 (59.1%) completed the run-in period and qualified for the main study. Over the 12-week main study period, 87.4% (243/278) of participants met the definition of adherence to protocol-specified data collection for weekly ePRO, and 57.2% (159/278) did so for daily ePRO. For smartwatch data, 81.7% (227/278) of the participants adhered to the protocol-specified data collection. In total, 52.9% (147/278) of the participants met composite adherence. CONCLUSIONS: Compared with other digital health rheumatoid arthritis studies, a short run-in period appears useful for identifying participants likely to engage in a study that collects data via a mobile app and wearables and gives participants time to acclimate to study requirements. Automated or manual prompts (ie, "It's time to sync your smartwatch") may be necessary to optimize adherence. Adherence varies by data collection type (eg, ePRO vs smartwatch data). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14665.

Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Using Biosensor and Patient-Reported Outcome Data: Protocol for a Real-World Study.

BACKGROUND: Rheumatoid arthritis (RA) is a condition with symptoms that vary over time. The typical 3- to 6-month interval between physician visits may lead to patients failing to recall or underreporting symptoms experienced during the interim. Wearable digital technology enables the regular passive collection of patients' biometric and activity data. If it is shown to be strongly related to data captured by patient-reported outcome (PRO) measures, information collected passively from wearable digital technology could serve as an objective proxy or be complementary to patients' subjective experience of RA symptoms. OBJECTIVE: The goal of this study is to characterize the extent to which digital measures collected from a consumer-grade smartwatch agree with measures of RA disease activity and other PROs collected via a smartphone app. METHODS: This observational study will last 6 months for each participant. We aim to recruit 250 members of the ArthritisPower registry with an RA diagnosis who will receive a smartwatch to wear for the period of the study. From the ArthritisPower mobile app on their own smartphone device, participants will be prompted to answer daily and weekly electronic PRO (ePRO) measures for the first 3 months. RESULTS: The study was launched in December 2018 and will require up to 18 months to complete. Study results are expected to be published by the end of 2021. CONCLUSIONS: The completion of this study will provide important data regarding the following: (1) the relationship between passively collected digital measures related to activity, heart rate, and sleep collected from a smartwatch with ePROs related to pain, fatigue, physical function, and RA flare entered via smartphone app; (2) determine predictors of adherence with smartwatch and smartphone app technology; and (3) assess the effect of study-specific reminders on adherence with the smartwatch. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14665.

The neuroscience ICU nurse's perceptions about end-of-life care.

The purpose of this qualitative descriptive study was to describe neuroscience intensive care unit (NICU) nurses' perceptions regarding their roles and responsibilities in the decision-making process during the change in intensity of care and end-of-life care for patients. Twelve NICU nurses agreed to a private moderately structured interview. Three major themes summarize the data: (1) providing guidance, (2) being positioned in the middle of the communication process, and (3) feeling the emotions of patients and families. The nurse caring for a patient at the end of life provides guidance from the middle or "hub" of the communication process between family members and physicians. The nurses in this study describe an array of feelings associated with this role. This research adds to the limited body of knowledge concerning critical care nurses' experiences with end-of-life care. Providing guidance and being in the middle of the communication process can be a lonely, challenging, yet rewarding position. Results of this study provide a basis for offering emotional support to NICU nurses who care for patients at the end of life.

Examining older adults' perceptions of health care providers: identifying important aspects of older adults' relationships with physicians and nurses.

This article describes older adults' conversations about their relationships with health care providers. Focus group participants (N = 23) were from three ethnic groups (Black, White, and Hispanic) and ages 53 to 92. All but three of the participants were women. Content analysis revealed an overarching theme of genuine caring and three sub-themes: interest in patients' well-being, respectful dialogue, and sharing of information. Older adults' perceptions of genuine caring by physicians and nurses did not differ by ethnicity. Older adults want to engage in a caring, respectful, and educational relationship with their health care providers, which is consistent with fundamental professional values.

Casting light on the concept of patient satisfaction by studying the construct validity and the sensitivity of a questionnaire.

PURPOSE: This study aims to explore the construct validity and the sensitivity of a patient satisfaction questionnaire for the purpose of gaining a better understanding of the concept, and of issues surrounding its measurements. DESIGN/METHODOLOGY/APPROACH: Several statistical analyses were used to study the reliability, construct validity, and the sensitivity of a patient satisfaction questionnaire. FINDINGS: The study supported the construct validity, high internal consistency, and homogeneity of the instrument. Two factors were found; one consisted of negatively worded items and the other of positively worded items. The negatively worded items contributed more than the positively worded items to the sensitivity of the instrument. Items were identified that contribute little or nothing to the construct validity and/or the sensitivity of the questionnaire. RESEARCH LIMITATIONS/IMPLICATIONS: The effect of wording on the variability and sensitivity of the instrument can be explained both as a consequence of response set bias and with regard to the theories against which two phenomena were being measured - patient satisfaction and patient dissatisfaction. The development of two kinds of instruments is proposed: those that measure patient dissatisfaction and are sensitive to minute changes in nursing care and those that measure both concepts and capture what patients find important in their care. ORIGINALITY/VALUE: The paper demonstrates how an analysis of the construct validity and the sensitivity of patient satisfaction instrument, can enhance understanding of the concept. It contributes to the debate about whether patient satisfaction and dissatisfaction are opposite ends of the same continuum or two different phenomena that require two different definitions.

Assessing advance care planning readiness in individuals with kidney failure.

The purpose of this study was to initiate development of an instrument to assess readiness of patients to discuss advance care plans. The first step of the development of the instrument involved the generation of a 49-item pool representative of the grounded theory of personal preservation (Calvin, 2004). The second step was to assess the content validity of the items using both a professional panel of four experts in end-of-life care and a patient panel of five persons currently being treated with hemodialysis in an inpatient setting. The third step was to pilot test the resultant 30-item instrument with another sample of 10 patients on hemodialysis. The instrument showed preliminary evidence of content validity (overall content validity index = 0.90) and internal consistency reliability of the scale (Cronbach's alpha = 0.73).

Understanding of advance care planning by family members of persons undergoing hemodialysis.

The purpose of this qualitative descriptive study was to explore hemodialysis patients' family members' understanding of end-of-life decision-making processes. The project aimed to address (a) family members' constructions of advance care planning (ACP), including their roles and responsibilities, and (b) family members' perceptions of health care providers' roles and responsibilities in ACP. Eighteen family members of persons undergoing hemodialysis were recruited primarily from outpatient dialysis facilities and interviewed individually. Confirmed transcript data were analyzed, coded, and compared, and categories were established. Interpretations were validated throughout the interviews and peer debriefing sessions were used at a later stage in the analysis. The overarching construct identified was one of Protection. Family members protect patients by (a) Sharing Burdens, (b) Normalizing Life, and (c) Personalizing Care. Recommendations for future research include the need to explore ACP of persons undergoing hemodialysis who do not have a family support system.

Managing cardiac devices near the end of life: a survey of hospice and palliative care providers.

Implantable cardioverter defibrillators (ICDs) and pacemakers may change the character of an individual's eventual death. The objective of this study was to explore hospice and palliative care provider attitudes and experience in managing ICDs and pacemakers for patients near the end of life. A voluntary survey was distributed to session attendees at a national conference. Doctors and nurses surveyed overwhelmingly agreed it is appropriate to disable these devices in a terminally ill patient who does not wish to be resuscitated or prolong life. However, respondents emphasized a less defined burden for pacemakers. Respondents also reported limited involvement in such cases and few institutional protocols. As more terminal patients have these devices, research and education on device management protocols/guidelines and on provider communication skills are critical.

The cardiovascular intensive care unit nurse's experience with end-of-life care: a qualitative descriptive study.

PURPOSE: Nurses in the cardiovascular intensive care unit (CVICU) informally expressed moral angst when caring for patients who are approaching the end of life. The purpose of this study was to better understand CVICU nurses' perceptions about their roles and responsibilities in the decision-making process about change in intensity of care and end-of-life care for patients within the CVICU setting. PARTICIPANTS AND METHODS: Nineteen nurses from one CVICU consented to being interviewed individually regarding their experiences caring for patients approaching the end of life, and specifically regarding the initiation of a change in code status. Investigators used a qualitative descriptive approach to collect and analyse the data. Transcript data were analysed and as concepts emerged they were compared with those from earlier interviews to establish similarities and differences. Investigators reached consensus about the major themes. FINDINGS: Analysis revealed four major themes: (a) exhausting patient treatments; (b) promoting family presence; (c) acknowledging physician authority; and (d) walking a fine line. CONCLUSIONS: This research adds to the limited body of knowledge concerning CVICU nurses' experiences with end-of-life care. Results of this study provide a basis for putting in place support systems for CVICU nurses.

Understanding of genetics among older adults.

PURPOSE: To describe and compare the attitudes, knowledge, and beliefs of older adults from three ethnic groups about genetic testing and genetic research, to determine how the understanding of genetics influences informed consent, and to identify factors that are important in older adults' decisions about participation in genetic research. METHODS: Three focus groups were initially conducted with 23 African American, Caucasian, and Hispanic adults in community-based settings. Discussions were audiotaped and transcribed verbatim. Content analysis of transcripts was performed and a second session was conducted with participants from each group to confirm the analyses. FINDINGS: Four common themes related to genetics and informed consent for genetic testing were identified: (a) defining genetics, (b) justifying genetic testing, (c) family involvement, and (d) dignified agreement. CONCLUSIONS: The findings from this study indicate that although these older adults had information about genetics, the information was not always accurate. In addition, deference among this cohort to providers' opinions showed the important role of healthcare professionals in providing genetic information and obtaining consent in ways that ensure it is voluntary and informed.

A legacy for the children--attitudes of older adults in the United Kingdom to genetic testing.

AIM: The aim of this study was to assess understanding of genetics and attitudes towards genetic testing for clinical and research purposes in a group of older adults in the UK. BACKGROUND: Increasingly, genomics will have an impact on the diagnosis, prevention and treatment of common diseases and the prescription of drugs. The chance of being affected by a medical condition increases with age and therefore the use of genetic testing as part of general health-care practice has an impact on the older population. METHODS: Older adults were recruited to two focus groups (n=7 and n=10 respectively). Focus group discussions were guided by a series of questions and were audiotaped. The transcribed data were coded for significant statements, which were organized under thematic headings. RESULTS: The mean age of participants was 76 years. The main themes to emerge were: understanding, approach to genetic testing and conditions for testing. In this cohort, the older adults were largely unsure about the underlying scientific basis of genetics but were keen to learn more. While enhanced medical knowledge could enable preventive measures to be taken and so reduce suffering, it was acknowledged that for some people knowing the future could potentially cause anxiety and harm. Participants were wary about research being used to benefit private companies and voiced ethical concerns about potential coercion to be tested and the misuse of science. However, all participants had an altruistic approach that influenced their willingness to be tested to benefit others in their family or the wider community. Conditions for testing included provision of information about the purpose of testing and feedback on the results. CONCLUSIONS: Older adults are positive about the opportunities presented by genetic testing for clinical reasons and research, but need accurate information about the reasons for and implications of such testing. RELEVANCE TO CLINICAL PRACTICE: The results of this study confirm the need for nurses to be proactive in developing the genetic competencies required to detect potential familial disease, make appropriate referrals to genetic services and ensure informed consent is obtained for genetic testing.

Haemodialysis patients and end-of-life decisions: a theory of personal preservation.

BACKGROUND: Lack of knowledge about the end-of-life treatment preferences of patients undergoing haemodialysis is problematic in the acute care setting as, often, patients are unable to communicate their treatment wishes effectively and have not previously documented their desires in the form of advance directives. Existing theoretical models offer an incomplete explanation of end-of-life treatment decisions in haemodialysis patients. AIM: This paper reports a study exploring decisions about end-of-life treatment (e.g. cardiopulmonary resuscitation, mechanical ventilation) in people with kidney failure undergoing haemodialysis. METHODS: Grounded theory was used. Theoretical sampling led to selection of 20 haemodialysis patients (11 men and nine women with a mean age of 56) who attended three dialysis outpatient centres in central Texas. They were interviewed about end-of-life treatment plans and the use of advance directives (i.e. living wills and durable powers of attorney for health care). Interviews, transcripts and field notes from the first 12 patients were analysed by making constant comparisons. The remaining eight interviews were used for validation purposes. Data collection and analysis spanned the years 1997-2000. FINDINGS: When prompted to think about and discuss end-of-life treatments, haemodialysis patients chose to focus on living rather than dying. A substantive theory of 'personal preservation' was developed. This consists of three phases: knowing the odds for survival, defining individuality (beating the odds, discovering meaning, being optimistic and having faith in a higher force) and personal preservation (being responsible and taking chances). CONCLUSIONS: The theory of personal preservation furthers understanding of illness behaviour and the process by which patients make decisions about end-of-life treatments. It can be used to sensitize health care professionals to patients' desires and to enhance patient-professional communication.