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.

Use of Comprehensive Participatory Planning and Evaluation in Rural Patient Engagement.

Comprehensive participatory planning and evaluation (CPPE), a model used in community engagement research, has not been applied to patient engagement in research. We describe our methodology and interim results using CPPE in a project focused on improving research engagement of rural and distant patients and stakeholders. Specifically, we describe our development of a causal map and the subsequent use of the map to guide patient and stakeholder-driven evaluation.

Systematic review of basic oral care for the management of oral mucositis in cancer patients and clinical practice guidelines.

PURPOSE: The aim of this study was to update the clinical practice guidelines for the use of basic oral care (BOC) interventions for the prevention and/or treatment of oral mucositis (OM). METHODS: A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO). The body of evidence for each intervention in each cancer treatment setting was assigned an evidence level. The findings were added to the database used to develop the 2013 MASCC/ISOO clinical practice guidelines. Based on the evidence level, one of the following three guideline determinations was possible: Recommendation, Suggestion, No guideline possible. RESULTS: A total of 17 new papers across six interventions were examined and merged with a previous database. Based on the literature, the following guidelines were possible. The panel suggests that the implementation of multi-agent combination oral care protocols is beneficial for the prevention of OM during chemotherapy, head and neck (H&N) radiation therapy (RT), and hematopoietic stem cell transplantation (Level of Evidence III). The panel suggests that chlorhexidine not be used to prevent OM in patients undergoing H&N RT (Level of Evidence III). No guideline was possible for professional oral care, patient education, saline, and sodium bicarbonate, and expert opinion complemented these guidelines. CONCLUSIONS: The evidence supports the use of multi-agent combination oral care protocols in the specific populations listed above. Additional well-designed research is needed on the other BOC interventions prior to guideline formulation.

Evidence-based interventions for cancer treatment-related mucositis: putting evidence into practice.

Mucositis is an inflammatory process that can involve the mucosal epithelial cells from the mouth to the rectum. Historically, mucositis and stomatitis were used interchangeably, but momentum has increased toward more specific terminology since the 2000s. Stomatitis refers to inflammatory diseases of the mouth, including the mucosa, dentition, periapices, and periodontium, whereas mucositis refers more globally to an inflammatory process involving the mucous membranes of the oral cavity and the gastrointestinal tract. In addition, differentiation is needed regarding mucositis involving the oral cavity and the remainder of the gastrointestinal tract that require use of a scope-type device for close examination. As a result, oral cavity mucositis has been the focus of the majority of the studies reported to date. The mucous membranes beyond the oral cavity are more challenging to view, so the mouth has been presented as revealing potential changes in the gastrointestinal tract. However, because of the variation in morphology, function of different locations, and risks associated with procedures to validate that speculation, evidence is limited. The purpose of this article is to review evidence-based interventions for mucositis, particularly in the oral cavity, and provide clinicians with guidelines for nursing interventions.

Systematic review of basic oral care for the management of oral mucositis in cancer patients.

PURPOSE: The purpose of this project was to evaluate research in basic oral care interventions to update evidence-based practice guidelines for preventing and treating oral mucositis (OM) in cancer patients undergoing radio- or chemotherapy. METHODS: A systematic review of available literature was conducted by the Basic Oral Care Section of the Mucositis Study Group of MASCC/ISOO. Seven interventions--oral care protocols, dental care, normal saline, sodium bicarbonate, mixed medication mouthwash, chlorhexidine, and calcium phosphate--were evaluated using the Hadorn (J Clin Epidemiol 49:749-754, 1996) criteria to determine level of evidence, followed by a guideline determination of one of the following: recommendation, suggestion, or no guideline possible, using Somerfield's (Classic Pap Cur Comments 4:881-886, 2000) schema. RESULTS: Fifty-two published papers were examined by treatment population (radiotherapy, chemotherapy, and hematopoietic stem cell transplant) and by whether the intervention aimed to prevent or treat OM. The resulting practice suggestions included using oral care protocols for preventing OM across all treatment modalities and age groups and not using chlorhexidine mouthwash for preventing OM in adults with head and neck cancer undergoing radiotherapy. Considering inadequate and/or conflicting evidence, no guidelines for prevention or treatment of OM were possible for the interventions of dental care, normal saline, sodium bicarbonate, mixed medication mouthwash, chlorhexidine in patients receiving chemotherapy or hematopoietic stem cell transplant, or calcium phosphate. CONCLUSIONS: The evidence for basic oral care interventions supports the use of oral care protocols in patient populations receiving radiation and/or chemotherapy and does not support chlorhexidine for prevention of mucositis in head and neck cancer patients receiving radiotherapy. Additional well-designed research is needed for other interventions to improve the amount and quality of evidence guiding future clinical care.

Adult cancer pain.

Pain is a common symptom associated with cancer and its treatment. Pain management is an important aspect of oncologic care, and unrelieved pain significantly comprises overall quality of life. These NCCN Guidelines list the principles of management and acknowledge the range of complex decisions faced in the management oncologic pain. In addition to pain assessment techniques, these guidelines provide principles of use, dosing, management of adverse effects, and safe handling procedures of pharmacologic therapies and discuss a multidisciplinary approach for the management of cancer pain.

The lived experience of parents and guardians providing care for child transplant recipients.

CONTEXT: Little has been published about the caregiving experiences of the parents or guardians of children receiving liver or liver/intestinal transplants. OBJECTIVE: To describe the lived experiences of parents and guardians as they prepared for and provided postdischarge care to a child who received an isolated intestine or a liver/intestinal transplant and to assess the impact of transplants on parents' stress levels. DESIGN: Semistructured, audio-taped phone interviews of parents' and guardians' perceptions of their experiences preparing to and providing care to a child transplant recipient were transcribed verbatim and analyzed by the research team using established qualitative research methods. PARTICIPANTS: Five parents or guardians (3 mothers, 1 foster mother, and 1 grandfather) of children who received a transplant between 2000 and 2008 at age 11 months to 6.7 years. RESULTS: Responses to the interviews gravitated toward 3 focal points: the parents' and guardians' perceptions of their interactions with the transplant team, their interactions with the local health care systems, and caring for themselves and their child at home. CONCLUSION: In preparing parents and guardians to care for their children after discharge from the hospital, transplant teams need to be aware of differences between what we think we communicate and how it is interpreted by the parents and guardians, the relationships built between parents and guardians and health care teams, parents' attitudes and levels of stress, and the impact these factors have on care and the parents' and guardians' experience.

Swallowing dysfunction in cancer patients.

PURPOSE: Dysphagia (swallowing dysfunction) is a debilitating, depressing, and potentially life-threatening complication in cancer patients that is likely underreported. The present paper is aimed to review relevant dysphagia literature between 1990 and 2010 with a focus on assessment tools, prevalence, complications, and impact on quality of life in patients with a variety of different cancers, particularly in those treated with curative chemoradiation for head and neck cancer. METHODS: The literature search was limited to the English language and included both MEDLINE/PubMed and EMBASE. The search focused on papers reporting dysphagia as a side effect of cancer and cancer therapy. We identified relevant literature through the primary literature search and by articles identified in references. RESULTS: A wide range of assessment tools for dysphagia was identified. Dysphagia is related to a number of factors such as direct impact of the tumor, cancer resection, chemotherapy, and radiotherapy and to newer therapies such as epidermal growth factor receptor inhibitors. Concomitant oral complications such as xerostomia may exacerbate subjective dysphagia. Most literature focuses on head and neck cancer, but dysphagia is also common in other types of cancer. CONCLUSIONS: Swallowing impairment is a clinically relevant acute and long-term complication in patients with a wide variety of cancers. More prospective studies on the course of dysphagia and impact on quality of life from baseline to long-term follow-up after various treatment modalities, including targeted therapies, are needed.

Clinical update: prevention and management of oral mucositis in patients with cancer.

OBJECTIVES: To present a clinical update of evidence that applies to the development of a nursing plan of care for the prevention and treatment of oral mucositis related to cytotoxic therapy. DATA SOURCES: Research studies, review articles, evidence-based guidelines, web-based material, and clinical experience. CONCLUSION: Although high-level research evidence regarding mucositis remains limited, more is known now than at the time of the original article 4 years ago. Use of multiple types of evidence in developing a structured plan of care facilitates improved patient outcomes and the advancement of the current body of knowledge toward the shared health care professional goal of improved patient outcomes. IMPLICATIONS FOR NURSING PRACTICE: Nurses play a key role in the identification and use of evidence to guide the care of patients at risk for cytotoxic therapy-related oral mucositis.

Tools for assessing nausea, vomiting, and retching.

BACKGROUND: Chemotherapy-induced nausea, vomiting, and retching are recognized as having an impact on patients' overall physical well-being, quality of life, and treatment decisions. Although there are many tools available to measure aspects of these symptoms, few offer a complete and concise clinical assessment. OBJECTIVE: The purpose of this article was to provide a comprehensive overview of the various instruments available for the assessment of cancer-related nausea, vomiting, and retching. Analysis included symptoms measured, period evaluated, type of questions posed, and aspects of each symptom measured. METHODS: Searches were conducted to find relevant articles using nationally recognized oncology Web sites and 4 electronic databases including PubMed, MEDLINE/CINAHL and CINAHL/EBSCO, and Cochrane. RESULTS: This review includes a total of 25 instruments that were identified as meeting the inclusion criteria of having been developed, or adapted, for the adult population, with an oncology focus. CONCLUSION: The ideal instrument would include measurement of all 3 symptoms while remaining clear, concise, and clinically relevant. IMPLICATIONS FOR PRACTICE: Although only 1 instrument came close to meeting these criteria, this review provides nurses with specific information on a variety of instruments to assist providers in selecting the most appropriate instrument for their specific clinical setting. This comprehensive critique of instruments is important for nurses attempting to select a tool to guide optimum care for patients in the clinical setting.

The experience of spouses as informal caregivers for recipients of hematopoietic stem cell transplants.

Spouses often are the primary caregiver for the hematopoietic stem cell transplant (HSCT) recipients and participate in the transplant recipients' care throughout the HSCT trajectory. The purpose of this qualitative study was to explore and describe the experiences of spouses of HSCT recipients during the acute phase of the transplant trajectory. The participants were spousal caregivers (8 wives and 3 husbands) of transplant recipients. Each participant was interviewed 1 to 6 times. Data were analyzed using Spradley's domain analysis. As couples entered the transplant experience, spouses described a sense of dislocation from normal life. They were now riding a rollercoaster in the dark as they lived the uncertainty of this risky therapy. Spouses structured the uncertainty with rituals, formed a positive perspective, and envisioned the future. They described a caregiving role but also needed to balance "me and my world" with "us and our world."

NCCN Task Force Report. prevention and management of mucositis in cancer care.

Oral mucositis (OM) has emerged as a common cause of dose delays and interruptions of cancer therapies such as multicycle chemotherapy, myeloablative chemotherapy, and radiotherapy with or without concurrent chemotherapy of head and neck cancer. Research into both preventive and management strategies has lagged behind research into the common cancer treatment-related morbidities of nausea, vomiting, and cytopenias. This disparity is related to the complex risk assessment of multifactorial patient and treatment factors and different techniques of rating mucositis. In addition, relatively few clinical trials have focused on mucositis as a specific outcome. Currently, the only effective preventive strategies include the use of palifermin to prevent OM in the setting of hematopoietic stem cell transplantation and oral cryotherapy used in conjunction with bolus 5-FU, melphalan, or edatrexate. For the most part, managing OM relies on supportive care and symptom palliation. However, OM is a common problem associated with significant patient morbidity and increased resource use. The magnitude of the problem demands innovative approaches based on expert judgment as evidence accumulates to support specific recommendations. To improve this situation, the NCCN convened a multidisciplinary task force to address key issues. This report integrates expert judgment with a review of key literature on risk assessment, prevention, and treatment strategies, and provides recommendations for the overall management of OM.

Putting evidence into practice: evidence-based interventions for the management of oral mucositis.

Mucositis, an inflammation of the mucous membranes, is a commonly occurring side effect of chemotherapy and radiation. Oral mucositis can cause significant clinical consequences, such as pain, malnutrition, and local and systemic infections. Nurses have a critical role in all aspects of managing mucositis, including assessing it, teaching oral care, administering pharmacologic interventions, and helping patients cope with symptom distress. Mucositis can have a negative impact on the overall treatment experience, especially when severe pain or infections occur. Many interventions for managing mucositis exist; however, some are based in tradition or expert opinion and have not been studied in large, randomized, controlled trials. In addition, a variety of assessment tools are available, which creates confusion and difficulties when comparing interventions across studies. This article reviews empirical evidence related to interventions for oral mucositis. Oral care and rinses, pharmacologic interventions, and other techniques are evaluated. Gaps in the literature and opportunities for research, education, and practice changes are discussed.

Prevention and management of oral mucositis in patients with cancer.

OBJECTIVES: To review current evidence that applies to the development of a nursing plan of care for the prevention and treatment of oral mucositis related to cytotoxic therapy. DATA SOURCES: Research studies, review articles, evidence-based guidelines, web-based material, and clinical experience. CONCLUSION: Although high-level research evidence regarding mucositis is limited, use of multiple types of evidence in developing a structured plan of care facilitates improved patient outcomes and the advancement of the current body of knowledge. IMPLICATIONS FOR NURSING PRACTICE: Nurses play a key role in the identification and use of evidence to guide the care of patients at risk for cytotoxic therapy-related oral mucositis.

Independent nursing actions in cooperative care.

PURPOSE/OBJECTIVES: To identify and describe independent nursing actions in cooperative care. DESIGN: Qualitative, descriptive, inductive study. SETTING: The Nebraska Medical Center's Lied Transplant Center in Omaha, where lay care partners assume responsibility for acute care of transplant recipients in partnership with nurses. SAMPLE: 12 cooperative care nurses. METHODS: Two focus groups, 59 narrative logs, and three follow-up interviews were tape recorded, transcribed, and content analyzed. MAIN RESEARCH VARIABLE: Independent nursing actions in cooperative care. FINDINGS: Independent nursing actions included surveillance, teaching, coaching, fostering partnerships, providing psychosocial support, rescuing, and coordinating. Surveillance leads to problem identification that, in turn, triggers other actions. Because all nursing actions occur in the context of nurse, dyad, and healthcare team relationships, coordinating is the category of nursing action used to manage all aspects of care. CONCLUSIONS: The nurses integrated specialized knowledge and expertise while dynamically using surveillance to identify problems that trigger nursing actions to manage signs and symptoms. Cooperative care is an example of apprenticeship or guided participation in which a community of experts (nurses) guides, supports, and challenges novices (lay individuals) to participate in skilled activities until the responsibility for the activities can be transferred to the novice. IMPLICATIONS FOR NURSING: Independent nursing actions identified in this study are the first step in formulating an instrument to measure "doses" (frequency and intensity) of nursing actions in cooperative care. Such an instrument is needed to evaluate interventions designed to prepare and support lay care partners.

Quality of life 5 or more years post-autologous hematopoietic stem cell transplant.

This cross-sectional study used a mailed survey to evaluate the quality of life (QOL) of individuals at least 5 years post-autologous stem cell transplant and to determine instrument preference. Instruments selected were the Medical Outcomes Study-Short Form (MOS-SF-36) as the generic measure and the City of Hope-Quality of Life-Bone Marrow Transplant (COH-BMT) and the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as transplant-specific measures. Subjects received the MOS-SF-36 and were randomized to receive (1) COH-BMT, (2) FACT-BMT, or (3) COH-BMT and FACT-BMT. Ninety-two subjects returned completed forms, for a 56% response rate. A study-specific form indicated subjects preferred the BMT-specific instruments. The health of the majority of subjects (85%) was similar to or somewhat better than what it was the previous year. Their MOS-SF-36 scores for physical functioning, role-physical, bodily pain, and general health subscales were lower than the values for the general population, but those for the other subscales were not significantly different. When compared to the data reported by Hann and colleagues for posttransplant in breast cancer, study subjects scored significantly lower on all scales except General Health and Mental Health. COH-BMT scores compared with those reported by Whedon and Ferrel (Semin Oncol Nurs. 1994;10:42-57) were higher for Physical Well-Being, Spiritual Well-Being, and Global QOL. FACT-BMT results compared with those reported by McQuellen et al (Bone Marrow Transplant. 1997;19:357-368) showed that Physical, Social/Family, Emotional, and Functional Scores were similar; only BMT scores were significantly different. Research is needed to determine when QOL plateaus and whether instrument preference changes over time. Awareness of long-term effects that affect QOL can guide program revisions and facilitate decisions regarding the need for supportive rehabilitative services.

Identification and validation of competencies for use in objective structured clinical examinations for lay caregivers.

Cancer care has shifted from the traditional hospital to alternative settings, thus requiring lay individuals to assume increased direct care responsibility. Cooperative Care is an example of an alternative acute care delivery model where a family member or a friend is responsible for care previously provided by healthcare professionals. The success of alternative models is dependent on effective educational programs with clearly defined expectations and methods for evaluating caregiver competence. Objective structured clinical examinations (OSCEs) provide a standardized approach to evaluating caregiver performance in a simulated situation. The purpose of the first phase of this instrument development project was to identify and validate competencies for inclusion in OSCEs to be used with lay caregivers in preparation for Cooperative Care. The study included multiple methods of data collection: analysis of documents, viewing videos, observation with note taking, and a focus group session. All classes and materials provided for lay caregivers were reviewed. Core content domains and competencies were identified and used to develop OSCEs. A focus group of healthcare providers responsible for the education and care of patients and their caregivers validated the competencies embedded within the OSCEs. This study demonstrated the efficacy of the approach used for the identification and validation of competencies for lay caregivers.

Tracking patient education documentation across time and care settings.

Results of a formative evaluation of a patient education documentation system will be presented. Both quantitative and qualitative approaches to data collection are being used. The goal of integrating patient education documentation into the electronic patient record is to facilitate seamless, multidisciplinary patient/family education across time and settings. The system is being piloted by oncology services at The Nebraska Medical Center. The evaluation addresses the usability and comprehensiveness of the system.