Methodological considerations for the design and implementation of a fully longitudinal mixed methods study.

Growing interest is evident in longitudinal mixed methods research, particularly fully longitudinal mixed methods designs in which both quantitative and qualitative data are collected concurrently for the duration of the study. Fully longitudinal mixed methods designs are particularly relevant for research on dynamic phenomena because of their ability to illuminate both quantitative and qualitative dimensions of change in real time as the phenomenon of interest changes. However, these are complex research designs and their data-intense nature makes them potentially burdensome for study participants, challenging for research teams, and costly for funding agencies. Despite growing use, the methodological literature on fully longitudinal mixed methods research is sparse and little guidance is available for researchers considering this approach. We address this gap by describing our experience with the design and implementation of a fully longitudinal mixed methods study of a dynamic phenomenon, namely, family caregiving during cancer treatment. We describe important questions and key decisions confronted while developing the research proposal, proactive strategies for study implementation, and implementation realities encountered while the study was in progress. On the basis of insights gained through real-world experience, we offer three guiding principles for researchers undertaking such a study. First, align the study design with the nature of the dynamics in the phenomenon of interest. Second, plan from the start when and how the integration of the longitudinal quantitative and qualitative data will occur. Third, employ implementation strategies that take into account the practical aspects of repeated contacts with study participants for an extended period.

The Experience of Complex Pain Dynamics in Oncology Outpatients: A Longitudinal Qualitative Analysis.

BACKGROUND: Few qualitative studies of cancer patients' everyday experiences with pain exist within the large body of cancer pain research. Longitudinal qualitative studies are particularly sparse, and no studies have qualitatively described patients' pain experience over time during participation in a self-management intervention. OBJECTIVE: To longitudinally describe patients' pain experiences during a 10-week pain self-management intervention. METHODS: This qualitative study was embedded in a randomized controlled trial of a psychoeducational pain management intervention. The data consisted of transcribed audio recordings of each intervention session. An emergent, interpretive approach was used in this longitudinal qualitative analysis. RESULTS: Forty-two adult patients were included. The analysis revealed the strikingly dynamic nature of individual patient's pain experiences. Multiple facets of pain contributed to its dynamic nature, including pain in changing locations, co-occurring sources of pain, and varying patterns of pain intensity over time. For individual patients, the cumulative effect of these multiple facets resulted in a phenomenon we termed "complex pain dynamics." CONCLUSION: The results contribute to knowledge about the dynamic nature of cancer patients' pain experiences over a relatively short period. They suggest the need for a new paradigm for management of pain in cancer patients and raise questions about the interpretation of randomized controlled trial results in the absence of qualitative data. IMPLICATIONS FOR PRACTICE: Frequent assessments and reassessments of pain are needed in cancer patients with the ongoing development of highly individualized self-management strategies. A large repertoire of interventions is needed to effectively manage pain in cancer patients over time.

A Longitudinal Study of Predictors of Constipation Severity in Oncology Outpatients With Unrelieved Pain.

CONTEXT: Although constipation is a common symptom in oncology patients, it often goes unrecognized and untreated. In addition, little is known about characteristics associated with interindividual differences in constipation severity. OBJECTIVES: To describe prevalence, characteristics, and management of constipation; evaluate interindividual differences in constipation severity over 10 weeks; and identify demographic, clinical, and symptom characteristics associated with higher constipation severity scores. METHODS: In this prospective, longitudinal study, 175 oncology patients with unrelieved pain were recruited from eight outpatient cancer settings in the U.S. Patients completed demographic and symptom questionnaires at enrollment. Constipation severity was evaluated over 10 weeks using the Constipation Assessment Scale (CAS). Hierarchical linear modeling was used to identify characteristics associated with higher CAS scores. RESULTS: At enrollment, 70.1% of the patients reported constipation [i.e., CAS score of >2; mean CAS score: 3.72 (±3.11)]. While over the first week of the study patients used one to two constipation treatments per day, a large amount of interindividual variability was found in CAS scores. Higher percentage of days with no bowel movement, higher number of constipation treatments, higher state anxiety scores, and higher analgesic side effects scores were associated with higher CAS scores at enrollment. Higher percentage of days with no bowel movement was associated with interindividual differences in the trajectories of constipation. CONCLUSION: Our findings underscore the high prevalence of and large amount of interindividual variability in constipation severity. The characteristics associated with worse CAS scores can assist clinicians to identify high-risk patients and initiate prompt interventions.

Couples' Experiences With Healthy Lifestyle Behaviors After Cardiac Rehabilitation.

PURPOSE: Many cardiac patients discontinue heart-healthy eating and physical activity (PA) behaviors in the months following cardiac rehabilitation (CR). Involving the spouse in CR with the patient may be 1 strategy to increase the maintenance of these behaviors after CR. Assisting patients and spouses with the maintenance of healthy eating and PA behavior following CR begins with a better understanding of the couple-focused factors, impacting their experiences with these behaviors. The purpose of this study was to qualitatively examine couple-focused facilitators and barriers to maintaining changes in healthy eating and PA behavior from the perspectives of both cardiac patients and their spouses following phase 2 CR. METHODS: A purposive sample of 11 couples (patients undergoing postcoronary artery bypass graft surgery and their spouses) were selected from a larger randomized control trial. Semistructured, in-person interviews were conducted with patients and their spouses separately following CR. Data were analyzed using line-by-line coding to identify facilitator and barrier themes. RESULTS: Two couple-focused barrier themes emerged: unnegotiated situations and unshared behaviors. Two couple-focused facilitator themes emerged: supportive exchanges and partnerships. CONCLUSION: These findings will help guide interventions targeting changes in diet and PA behavior in both patients and their spouses through minimizing unnegotiated situations, fostering supportive exchanges, and creating a partnership for the couple to work together on shared diet and PA goals. Targeting both patients and their spouses may be an innovative and effective way to intervene to increase adherence to healthy eating and PA behaviors post-CR.

Pain medication management processes used by oncology outpatients and family caregivers part II: home and lifestyle contexts.

CONTEXT: Despite the increasing complexity of medication regimens for persistent cancer pain, little is known about how oncology outpatients and their family caregivers manage pain medications at home. OBJECTIVES: To describe the day-to-day management of pain medications from the perspectives of oncology outpatients and their family caregivers who participated in a randomized clinical trial of a psychoeducational intervention called the Pro-Self(©) Plus Pain Control Program. In this article, we focus on pain medication management in the context of highly individualized home environments and lifestyles. METHODS: This qualitative study was conducted as part of a randomized clinical trial, in which an embedded mixed methods research design was used. Audio-recorded dialogue among patients, family caregivers, and intervention nurses was analyzed using qualitative research methods. RESULTS: Home and lifestyle contexts for managing pain medications included highly individualized home environments, work and recreational activities, personal routines, and family characteristics. Pain medication management processes particularly relevant in these contexts included understanding, organizing, storing, scheduling, remembering, and taking the medications. With the exception of their interactions with the intervention nurses, most study participants had little involvement with clinicians as they worked through these processes. CONCLUSION: Pain medication management is an ongoing multidimensional process, each step of which has to be mastered by patients and their family caregivers when cancer treatment and supportive care are provided on an outpatient basis. Realistic patient- and family-centered skill-building interventions are needed to achieve effective and safe pain medication management in the contexts of individual home environments and lifestyles.

Pain medication management processes used by oncology outpatients and family caregivers part I: health systems contexts.

CONTEXT: Oncology patients with persistent pain treated in outpatient settings and their family caregivers have significant responsibility for managing pain medications. However, little is known about their practical day-to-day experiences with pain medication management. OBJECTIVES: The aim was to describe day-to-day pain medication management from the perspectives of oncology outpatients and their family caregivers who participated in a randomized clinical trial of a psychoeducational intervention called the Pro-Self(©) Plus Pain Control Program. In this article, we focus on pain medication management by patients and family caregivers in the context of multiple complex health systems. METHODS: We qualitatively analyzed audio-recorded intervention sessions that included extensive dialogue between patients, family caregivers, and nurses about pain medication management during the 10-week intervention. RESULTS: The health systems context for pain medication management included multiple complex systems for clinical care, reimbursement, and regulation of analgesic prescriptions. Pain medication management processes particularly relevant to this context were getting prescriptions and obtaining medications. Responsibilities that fell primarily to patients and family caregivers included facilitating communication and coordination among multiple clinicians, overcoming barriers to access, and serving as a final safety checkpoint. Significant effort was required of patients and family caregivers to insure safe and effective pain medication management. CONCLUSION: Health systems issues related to access to needed analgesics, medication safety in outpatient settings, and the effort expended by oncology patients and their family caregivers require more attention in future research and health-care reform initiatives.

Nursing home research: the first International Association of Gerontology and Geriatrics (IAGG) research conference.

The International Association of Gerontology and Geriatrics held its first conference on nursing home research in St Louis, MO, in November 2013. This article provides a summary of the presentations.

The state of the science of family caregiver-care receiver mutuality: a systematic review.

This review critically examines the current state of the science on the concept of family caregiver-care receiver mutuality, summarizes accomplishments and gaps and identifies directions for future theory development and research. Mutuality between family caregivers and care receivers is of increasing interest to researchers. However, no analysis of the current state of the science of this important concept has been published. Our literature search revealed 34 research articles that met inclusion criteria. The studies were assessed in terms of conceptualization of mutuality, instrument development, populations studied, research designs and methods and findings. Significant scientific progress during the past 30 years includes the development of clear definitions and new instruments, expansion of research beyond the clinical populations in which mutuality was first studied, the use of a variety of research designs, and increasingly sophisticated methods of data analysis. Growing evidence suggests that mutuality is associated with caregiver emotional health outcomes and may decrease over time in the context of chronic illness. Directions for future research include development of new theoretical frameworks grounded in relational theory, development of theory on the dynamics of mutuality over time, exploration of mutuality in diverse cultures and populations, and intervention studies aimed at enhancing mutuality.

Intervention fidelity in a translational study: lessons learned.

This article examined the intervention fidelity strategies used and lessons learned in a translational study. In this study, the behavioral intervention was delivered within an existing clinical practice environment, outpatient cardiac rehabilitation (CR). The primary lessons learned were that the fidelity components of design, training, and delivery of the intervention were the most different from fidelity strategies used in typical intervention studies. The design component needed to take into account the unique characteristics of the clinical environments where the study was conducted and build these unique differences into the study design. Training and delivery of the intervention was different because existing CR staff delivered the intervention in this study; which is unlike typical intervention studies where research staff are trained to deliver the intervention. Monitoring receipt and enactment fidelity components were similar to monitoring in usual intervention studies probably because these components focus on monitoring the behaviors of the research participant. Translational research presents unique challenges and requires the development of a flexible and novel intervention fidelity plan tailored to a particular study.

Caregiving demand and difficulty in older adult spousal caregivers after coronary artery bypass surgery.

The purpose of this study was to describe the caregiving demands and difficulties for older adult spousal caregivers of coronary artery bypass (CAB) surgery patients. Caregiving demands and difficulties were measured by the Caregiving Burden Scale. The sample size was 35 caregivers of CAB surgery patients who were, on average, 60 years old and 19 days since hospital discharge. Descriptive analysis revealed that the top four most demanding caregiving activities perceived by spousal caregivers were providing transportation, additional household tasks, providing emotional support, and two tied for fourth: monitoring symptoms and additional tasks outside the home. The top four most difficult caregiving tasks were additional household tasks, providing transportation, and two tied for third: additional tasks outside home and managing behavior problems. Also, caregivers reported experiencing more demands than difficulties. Examining the demanding and difficult caregiving tasks provides information from which to develop and test tailored interventions for caregivers of this population.

Care transitions: integrating transition theory and complexity science concepts.

Care transitions, defined as hospital discharge or movement from one health care setting to another, are currently a major concern of health care providers and policy makers. Extensive empirical research has been conducted on care transitions, but the theoretical foundations are rarely made explicit. We propose that integrating concepts on complex adaptive systems from complexity science with classic theory on transitions in nursing provides a powerful new lens through which to study care transitions and improve transition outcomes. We summarize concepts from both theoretical approaches, propose an expanded model of transitions, and apply the model to the transition from hospital to home.

Trajectories of fatigue in family caregivers of patients undergoing radiation therapy for prostate cancer.

Predictors of and trajectories for evening and morning fatigue were evaluated in family caregivers of oncology patients using hierarchical linear modeling. Evening fatigue trajectory fit a quadratic model. Predictors included baseline sleep disturbances in family caregivers and baseline evening fatigue in patients. Morning fatigue trajectory fit a linear model. Predictors were baseline trait anxiety, levels of perceived family support, and baseline morning fatigue in patients. Findings suggest considerable inter-individual variability in the trajectories of evening and morning fatigue. Evaluating family caregivers for sleep disturbance, anxiety, and poor family support, as well as high levels of patient fatigue, could identify those family caregivers at highest risk for sustained fatigue trajectories.

Effects of caregiving demand, mutuality, and preparedness on family caregiver outcomes during cancer treatment.

PURPOSE/OBJECTIVES: To test a model of family caregiving derived from the interactionist approach to role theory that hypothesized that three caregiving role implementation variables (caregiving demand, mutuality between caregivers and patients, and preparedness for caregiving) would predict multiple caregiving-specific and generic outcomes with different patterns of association across outcomes. DESIGN: Descriptive, correlational. SETTING: Surgical, radiation, and medical oncology settings. SAMPLE: 87 family caregivers of adults receiving treatment for solid tumors or lymphoma. METHODS: Caregivers completed the Demand and Difficulty subscales of the Caregiving Burden Scale; the Mutuality, Preparedness, and Global Strain scales of the Family Care Inventory; and the 30-item short form of the Profile of Mood States. Data were analyzed with simultaneous multiple regression. MAIN RESEARCH VARIABLES: Caregiving demand, mutuality, preparedness, caregiving difficulty, global caregiver strain, tension, depression, anger, fatigue, vigor, confusion, and total mood disturbance. FINDINGS: The model explained statistically significant proportions of variance in each outcome, with different patterns of association across outcomes. Demand was associated most strongly with caregiving difficulty and global strain. Mutuality was associated most strongly with caregiver anger. Unexpectedly, preparedness was associated more strongly with mood disturbance outcomes than with the caregiving-specific variables of difficulty and strain. CONCLUSIONS: Further research should explore models that address implementation of the caregiving role to better elucidate how family caregivers learn and carry out the important role. IMPLICATIONS FOR NURSING: Clinical assessment should include caregiving demand, the quality of the relationship between caregiver and patient, and preparedness for caregiving. Interventions could be tailored to meet caregiver needs in each area.

Symptom experience of family caregivers of patients with cancer.

OBJECTIVES: To review the literature on depression, anxiety,sleep disturbance, fatigue, and pain in family caregivers of patients with cancer in the context of the Symptom Management Model (SMM)developed at the University of California, San Francisco (UCSF). DATA SOURCES: Published research studies and systematic reviews from 1990-2007. DATA SYNTHESIS: Studies of depressive symptoms in caregivers of patients with cancer were the most numerous. A limited number of studies examined anxiety, fatigue, sleep disturbance, and pain. Most studies focused on the symptom experience dimension of the UCSF SMM. CONCLUSIONS: Based on the small sample sizes, cross-sectional nature of the studies, and lack of comparison groups, little is known about the prevalence and effects of symptoms in caregivers of patients with cancer. IMPLICATIONS FOR NURSING: Additional research is needed to determine the prevalence, severity, and effects of symptoms on caregivers. Better descriptive, correlational studies will lead to the development of interventions to improve symptom management for this group of caregivers.

Mutuality and preparedness moderate the effects of caregiving demand on cancer family caregiver outcomes.

BACKGROUND: Family caregiving researchers have explored the moderating or stress-buffering effects of variables such as coping and social support. However, the quality of the family caregiver-patient relationship and preparedness for caregiving have received little attention as potential moderators. OBJECTIVE: To explore whether relationship quality and preparedness moderate the effects of caregiving demand on caregiver outcomes during cancer treatment. METHODS: Eighty-seven family caregivers of patients receiving treatment for cancer completed the Demand and Difficulty subscales of the Caregiving Burden Scale, Mutuality and Preparedness Scales of the Family Care Inventory, and the short form of the Profile of Mood States. Using hierarchical multiple regression analyses, caregiving difficulty and total mood disturbance were regressed on two- and three-way interaction terms for demand, mutuality, and preparedness, controlling for caregiver age and gender, and the simple effect of each independent variable. RESULTS: Negligible effects for two-way interactions were found. However, the three-way interaction between demand, mutuality, and preparedness explained statistically significant variance in both perceived difficulty of caregiving and total mood disturbance. High mutuality in combination with high preparedness protected caregivers from adverse outcomes when demand was high. When either mutuality or preparedness was low, caregivers were at greater risk for negative outcomes when demand was high, but not when demand was low. When both mutuality and preparedness were low, caregivers were at risk for mood disturbance even when demand was low. DISCUSSION: Analysis of three-way interactions provided new theoretical insights into the protective effects of mutuality and preparedness and demonstrated conditions under which caregivers are at increased risk for negative outcomes.

A transactional model of cancer family caregiving skill.

Family caregivers of persons receiving treatment of cancer must acquire illness-related skills not usually found among nonprofessional caregivers. Although research is needed to understand the skill acquisition process, no models of family caregiving skill exist to guide such research. The purpose of this study was to develop a model of caregiving skill through qualitative research. Participants were 44 caregiver/patient dyads and 63 individual caregivers. Data were collected using a semi-structured interview. A transactional model of family caregiving skill was developed that includes the concepts of demands of the illness situation, patterns of care, caregiver responses, and patient responses.

Qualitative research contribution to a randomized clinical trial.

Qualitative research may be combined fruitfully with intervention studies, but few examples provide detailed methodological strategies for doing so. In this article, we describe the qualitative component of a randomized clinical trial (RCT) of the PRO-SELF(c) Pain Control Program, an intervention that provides individualized education, coaching, and support for cancer pain management. We conducted three qualitative analyses of verbatim transcripts of "real-time" audiotaped intervention sessions. As a result, we were better able to ascertain the nature of the individualized coaching component of the intervention, patient and family caregiver use of selected intervention tools, and reasons the intervention did not work for some patients. Study results were used to increase the specificity with which the coaching portion of the intervention is described in the intervention protocol.

Home care nursing for older adults: state of the science.

This article describes the state of the science of home care nursing for older adults and its implications for clinical practice. Selected peer-reviewed research articles published since 1990 were reviewed and categorized into five broad areas: nursing classification studies, critical transitions in the illness trajectory, family education and support, specific conditions prevalent in home care, and population diversity. The science of home care nursing has progressed considerably since 1990 with increasing sophistication of research conceptualization and design and increasing numbers of studies published.

The usefulness of a daily pain management diary for outpatients with cancer-related pain.

PURPOSE/OBJECTIVES: To describe the usefulness of daily pain management diaries to outpatients with cancer who participated in a randomized clinical trial of the PRO-SELF Pain Control Program. DESIGN: Randomized clinical trial in which a daily pain management diary was used for data collection in the control group and for data collection and nurse coaching regarding the pain management program in the intervention group. SETTING: Seven outpatient oncology settings. SAMPLE: 155 patients with pain from bone metastases and 90 family caregivers. METHODS: Content and statistical analysis of audiotaped answers to a semistructured questionnaire. MAIN RESEARCH VARIABLES: Patients' and family caregivers' perceptions of the usefulness of a daily pain management diary; specific ways in which the diary was used. FINDINGS: Patients in both the intervention (75%) and control groups (73%) found the diary useful. The diary was used to heighten awareness of pain, guide pain management behavior, enhance a sense of control, and facilitate communication. Family caregivers in both groups also reported that the diary was useful. CONCLUSIONS: The completion of a daily pain management diary is useful to patients and family caregivers and may function as an intervention for self-care. IMPLICATIONS FOR NURSING: Research-based evidence supports the importance of using a daily pain management diary in clinical practice.

Pain management autobiographies and reluctance to use opioids for cancer pain management.

Although pain management education results in improved pain control for some patients, it does not work for all patients because some patients remain reluctant or unwilling to use prescribed analgesics to their optimal effect. In a randomized clinical trial that tested the effectiveness of the PRO-SELF Pain Control Program, 11 patients declined to increase their analgesic use despite moderate to severe pain. These patients were selected for a qualitative analysis of their audiotaped discussions about pain management with their intervention nurses. This analysis revealed that these patients often spontaneously provided detailed explanations about why they were reluctant or unwilling to take analgesics in general or opioids in particular. We termed these explanatory accounts pain management autobiographies because of their narrative character and multilayered, richly detailed quality. Pain management autobiographies included stories about (1) previous experience with chronic pain management, including stigmatizing interactions with clinicians and family members; (2) bad experiences with cancer pain management, including severe constipation; and 3) strongly held conventions about medication use, including the belief that all medications are "toxins" that should be avoided. The study findings suggest that a small subset of patients with cancer pain may need interventions such as individual or family counseling or alternative pain management strategies to augment education about opioids.