Devon K. Check

Summing it up: an integrative review of studies of cancer survivorship care plans (2006-2013).

In 2006, the Institute of Medicine recommended that cancer survivors who are completing primary treatment receive a survivorship care plan (SCP) based on face validity. The state of scientific knowledge regarding the SCP is unclear. The authors conducted an integrative review of existing evidence regarding SCPs. The MEDLINE/PubMed database, the Excerpta Medica Database (EMBASE), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) database were searched for relevant studies published between 2006 and 2013 using a combination of keywords: “survivors,” “survivorship,” “care plans,” “care planning,” “treatment summaries,” and “cancer.” Articles were included if they 1) reported results from an empirical study, 2) included cancer survivors who were diagnosed at age ≥18 years, 3) related to SCP, and 4) were published in English. In total, 781 records were retrieved; 77 were identified as duplicates, and 665 were abstracts or presentations that did not relate to SCPs for adults or were not empirical, which left 42 articles for inclusion in this review. Studies regarding SCP fell into 3 categories: 1) content (n=14), 2) dissemination and implementation (n=14), and 3) survivor and provider outcomes (n=14). SCPs have been endorsed and are associated with improved knowledge, but SCP use remains sporadic. Only 4 studies were randomized controlled trials (RCTs) that avoided many biases associated with observational studies. Other limitations included cross‐sectional or pre‐SCP–post‐SCP (“pre‐post”) designs, limited generalizability caused by a lack of sample diversity, and a lack of systematic testing of data‐collection tools. The quantity and quality of SCP research are limited. SCPs have been endorsed, but evidence of improved outcomes associated with SCP is limited. Future research that addresses the methodological concerns of extant studies is needed regarding SCP use, content, and outcomes. Cancer 2015;121:978–996.

Using central IRBs for multicenter clinical trials in the United States.

Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation’s capacity to efficiently conduct the large number of high-quality trials.

Transitional adherence and persistence in the use of aldosterone antagonist therapy in patients with heart failure

BACKGROUND Aldosterone antagonist therapy is recommended for selected patients with heart failure and reduced ejection fraction. Adherence to therapy in the transition from hospital to home is not well understood. METHODS We identified patients with heart failure and reduced ejection fraction who were ≥65 years old, eligible for aldosterone antagonist therapy, and discharged home from hospitals in the Get With the Guidelines-Heart Failure registry between January 1, 2005, and December 31, 2008. We used Medicare prescription drug event data to measure adherence. Main outcome measures were prescription at discharge, outpatient prescription claim within 90 days, discontinuation, and adherence as measured with the medication possession ratio. We used the cumulative incidence function to estimate rates of initiation and discontinuation. RESULTS Among 2,086 eligible patients, 561 (26.9%) were prescribed an aldosterone antagonist at discharge. Within 90 days, 78.6% of eligible patients with a discharge prescription filled a prescription for the therapy, compared with 13.0% of eligible patients without a discharge prescription (P < .001). The median medication possession ratio was 0.63 over 1 year of follow-up. Among 634 patients who filled a prescription within 90 days of discharge, 7.9% discontinued therapy within 1 year. CONCLUSION Most eligible patients were not prescribed aldosterone antagonist therapy at discharge from a heart failure hospitalization. Eligible patients without a discharge prescription seldom initiated therapy as outpatients. Most patients who were prescribed an aldosterone antagonist at discharge filled the prescription within 90 days and remained on therapy.

Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature

Background To improve the efficiency of conducting multicenter clinical trials, the Food and Drug Administration, the Office of Human Research Protections, and the Department of Health and Human Services have expressed support for using a centralized institutional review board (IRB) process. However, research institutions differ in their willingness to defer to central IRBs. Purpose We aimed to review and describe peer-reviewed journal articles on the use of central IRBs for multicenter clinical trials in the United States in an effort to inform the policy discussion about central IRBs. Methods We used a PubMed search and consulted IRB experts and the bibliographies of other reviews to identify relevant commentaries and empirical studies. Results Our search identified 33 articles related to the use of central IRBs for multicenter trials in the United States. Of these, 22 were commentary pieces and 11 were empirical studies. Limitations Our review was restricted to journal articles about the use of central IRBs for multicenter clinical trials in the United States. Conclusions There is limited empirical work on the use of central IRBs for multicenter trials in the United States. Most published studies focused on problems in efficiency associated with redundant local reviews of multicenter studies and the potential benefits of a centralized system. Because the absence of studies on the use of central IRBs may be due to their infrequent use, additional work is needed to generate data on the use of central IRBs and to elucidate and address the concerns that research institutions have about deferring ethical review to a central IRB.

Parenting concerns, quality of life, and psychological distress in patients with advanced cancer

Parents with life‐limiting illness anticipate the loss of their parental role and the long‐term consequences of their illness on their children. The purpose of this study was to examine relationships between parenting concerns, quality of life (QOL), and symptoms of depression and anxiety in parents with advanced cancer who have dependent children.

Guidelines for the use of survivorship care plans: a systematic quality appraisal using the AGREE II instrument

BackgroundSurvivorship care plans (SCPs) are written treatment summaries and follow-up care plans that are intended to facilitate communication and coordination of care among survivors, cancer care providers, and primary care providers. A growing number of guidelines for the use of SCPs exist, yet SCP use in the United States remains limited. Limited use of SCPs may be due to poor quality of these guidelines. The purpose of the study was to evaluate the quality of guidelines for SCP use, tools that are intended to promote evidence-based medicine.MethodsWe conducted a comprehensive search of the literature using MEDLINE/PubMed, EMBASE (Excerpta Medica Database), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) published through April 2014, in addition to grey literature sources and bibliographic and expert reviews. Guideline quality was assessed using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation, 2nd edition), a tool developed by an international group of scientists to advance the quality of clinical practice guidelines. To promote consistency with extant studies using the AGREE II instrument and to clearly and unambiguously identify potentially useful guidelines for SCP use, we also summarized AGREE II scores by strongly recommending, recommending, or not recommending the guidelines that we evaluated.ResultsOf 128 documents screened, we included 16 guidelines for evaluation. We did not strongly recommend any of the 16 guidelines that we evaluated; we recommended 5 and we did not recommend 11. Overall, guidelines scored highest on clarity of presentation (i.e., guideline language, structure, and format): Guidelines were generally unambiguous in their recommendations that SCPs should be used. Guidelines scored lowest on applicability (i.e., barriers and facilitators to implementation, implementation strategies, and resource implications of applying the guideline): Few guidelines discussed facilitators and barriers to guideline application; advice and tools for implementing guidelines were vague; and none explicitly discussed resource implications of implementing the guidelines.ConclusionsGuidelines often advocated survivorship care plan use without justification or suggestions for implementation. Improved guideline quality may promote survivorship care plan use.

Investigation of Racial Disparities in Early Supportive Medication Use and End-of-Life Care Among Medicare Beneficiaries With Stage IV Breast Cancer

PURPOSE Early supportive care may improve quality of life and end-of-life care among patients with cancer. We assessed racial disparities in early use of medications for common cancer symptoms (depression, anxiety, insomnia) and whether these potential disparities modify end-of-life care. METHODS We used 2007 to 2012 SEER-Medicare data to evaluate use of supportive medications (opioid pain medications and nonopioid psychotropics, including antidepressants/anxiolytics and sleep aids) in the 90 days postdiagnosis among black and white women with stage IV breast cancer who died between 2007 and 2012. We used modified Poisson regression to assess the relationship between race and supportive treatment use and end-of-life care (hospice, intensive care unit, more than one emergency department visit or hospitalization 30 days before death, in-hospital death). RESULTS The study included 752 white and 131 black women. We observed disparities in nonopioid psychotropic use between black and white women (adjusted risk ratio [aRR], 0.51; 95% CI, 0.35 to 0.74) but not in opioid pain medication use. There were also disparities in hospice use (aRR, 0.86; 95% CI, 0.74 to 0.99), intensive care unit admission or more than one emergency department visit or hospitalization 30 days before death (aRR, 1.28; 95% CI, 1.01 to 1.63), and risk of dying in the hospital (aRR, 1.59; 95% CI, 1.22 to 2.09). Supportive medication use did not attenuate end-of-life care disparities. CONCLUSION We observed racial disparities in early supportive medication use among patients with stage IV breast cancer. Although they did not clearly attenuate end-of-life care disparities, medication use disparities may be of concern if they point to disparities in adequacy of symptom management given the potential implications for quality of life.

Parenting while living with advanced cancer: A qualitative study:

Background: Patients with advanced cancer who have dependent children are an important population with a life-limiting illness and high levels of psychological distress. Few studies have addressed the experience of being a parent with advanced cancer and their potential palliative needs. Aim: To describe the experience of living with advanced cancer as a parent, including illness experience, parental concerns, and treatment decision making and to explore whether these experiences differ by their functional status. Design: We conducted a cross-sectional, qualitative study using in-depth, semi-structured interviews. Data were analyzed using thematic content analysis. Setting and participants: A total of 42 participants with metastatic cancer and with at least one child under the age of 18 years were recruited from a comprehensive cancer center. 25 participants were rated as having high functional status (the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale = 0–1) and 17 with low functional status (ECOG=2–4). Results: We identified four themes regarding the experience of being a parent with advanced cancer: (1) parental concerns about the impact of their illness and death on their children, (2) “missing out” and losses of parental role and responsibilities, (3) maintaining parental responsibilities despite life-limiting illness, and (4) parental identity influencing decision making about treatment. Parental functional status influenced not only physical responsibilities but also intensified parenting psychological concerns. Conclusion: Parents with metastatic cancer may have unique palliative care needs as they experience parenting concerns while managing the psychological and physical demands of advanced cancer.

Institutional review boards' use and understanding of certificates of confidentiality.

Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants’ privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public’s health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders’ views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions’ use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or ‘unsure’. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an ‘extra layer’ of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants’ confidentiality, and the need for further empirical investigation of Certificates’ effect on researchers and research participants.

An exploratory study of end-of-life prognostic communication needs as reported by widowed fathers due to cancer

Effective physician communication about prognosis is a critical aspect of quality care for families affected by terminal illness. This is particularly important for spousal caregivers of terminally ill parents of dependent children, who may have unique needs for communication about anticipated death. The objective of this study was to explore end‐of‐life prognostic communication experiences reported by bereaved fathers whose wives died from cancer.