Patients' understanding of oncology clinical endpoints: A literature review.

OBJECTIVES: Oncology clinical trials use a variety of clinical endpoints. Patients' understanding of the differences between clinical endpoints is important because misperceptions of treatment efficacy may affect treatment decisions. The objective of this literature review is to find and synthesize available empirical publications assessing patients' understanding of common oncology clinical endpoints. METHODS: We conducted a literature search of 5 databases and 3 conferences, limiting the search to articles and abstracts published in English through September 2018. We reviewed the titles and abstracts for inclusion, then reviewed full texts to determine if they reported empirical research studies focused on (1) clinical endpoints, (2) oncology, and (3) patient understanding. The original search identified 497publications, of which 13 met the inclusion criteria. RESULTS: Available literature yields little information on this topic.The few publications that do exist suggest that healthcare professionals and cancer patients generally do not discuss clinical endpoint concepts and that patients can be confused about the purpose of a treatment based on misperceptions about endpoints. CONCLUSIONS: Research is needed on how to discuss oncology clinical endpoints with patients. PRACTICE IMPLICATIONS: Patient-friendly definitions of clinical endpoints may help healthcare providers communicate important information about treatments to patients.

Direct-to-Consumer Advertising of Prescription Drugs and the Patient-Prescriber Encounter: A Systematic Review.

We systematically reviewed the research on patients' and prescribers' perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) (For ease of reading we use the term "advertising" to encompass advertising and promotional labeling. Broad use of this term does not imply endorsement by FDA) of prescription drugs that occurs in the context of a clinical encounter. This research offers an important perspective on the broader goal of incorporating patient and prescriber voices in decision-making. Outcomes included patient information seeking, medication adherence, patient requests for DTCA-promoted prescription drugs, prescribing behaviors, and perceptions of the patient-prescriber relationship and interactions. We searched PubMed and other databases from 1982-2017 and identified 38 studies meeting our study criteria. Of these, 24 studies used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Studies suggested some potential benefits of exposure to DTCA, including patients' enhanced information-seeking, increased patient requests for appropriate prescriptions (when addressing potential underuse) and patients' perceptions of higher-quality interactions with prescribers. Most prescribers perceived a neutral influence on the quality of their clinical interactions with patients regarding DTCA. Harms included patients receiving prescriptions for drugs that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medication adherence in some populations, such as those with mental illness. The potential benefits of DTCA on the patient-provider encounter must be balanced with the potential for harms.

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature.

Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about safety issues with prescription and over-the-counter drugs. We searched PubMed for peer-reviewed studies published from 1990 to 2017 where study authors reported probable unintended effects of communicating drug safety. The types of communications included in these studies were news reports, direct-to-consumer advertisements, and those released by government agencies. Among the 26 studies identified, the most commonly reported unintended effects were decreased drug use or discontinuation. Other unintended effects included spillover to populations not targeted by the communications (e.g., discontinuation of antidepressants among adults following communications concerning use among youth), shifts in clinical diagnoses (e.g., fewer diagnoses of depression), increased use of alternative therapies, and other undesirable behaviors (e.g., possible increased suicide attempts because antidepressants were discontinued). Limitations to the literature include the inability to establish causation or to isolate the effects of multiple communication sources and messages. Further, because the intended effect of many communications was not known, our study was limited by challenges in defining some effects as unintended. Most studies used health insurer claims data to identify unintended effects of communications, which provide an incomplete picture; few used self-reported or other methodologies that could help illuminate the reasons underlying the effects observed in the claims data. Best practices for communicating about the potential benefits and harms of drugs in a manner that minimizes negative unintended effects are needed to protect and improve public health.

Anticipated regret and health behavior: A meta-analysis.

OBJECTIVE: Risk beliefs are central to most theories of health behavior, yet many unanswered questions remain about an increasingly studied risk construct, anticipated regret. The authors sought to better understand anticipated regret's role in motivating health behaviors. METHOD: The authors systematically searched electronic databases for studies of anticipated regret and behavioral intentions or health behavior. They used random effects meta-analysis to synthesize effect sizes from 81 studies (n = 45,618). RESULTS: Anticipated regret was associated with both intentions (r+ = .50, p < .001) and health behavior (r+ = .29, p < .001). Greater anticipated regret from engaging in a behavior (i.e., action regret) predicted weaker intentions and behavior, whereas greater anticipated regret from not engaging in a behavior (i.e., inaction regret) predicted stronger intentions and behavior. Anticipated action regret had smaller associations with behavioral intentions related to less severe and more distal hazards, but these moderation findings were not present for inaction regret. Anticipated regret generally was a stronger predictor of intentions and behavior than other anticipated negative emotions and risk appraisals. CONCLUSIONS: Anticipated inaction regret has a stronger and more stable association with health behavior than previously thought. The field should give greater attention to understanding how anticipated regret differs from similar constructs, its role in health behavior theory, and its potential use in health behavior interventions. (PsycINFO Database Record

The psychological harms of screening: the evidence we have versus the evidence we need.

BACKGROUND: Systematic reviews for the US Preventive Services Task Force have found less high-quality evidence on psychological than physical harms of screening. To understand the extent of evidence on psychological harms, we developed an evidence map that quantifies the distribution of evidence on psychological harms for five adult screening services. We also note gaps in the literature and make recommendations for future research. METHODS: We systematically searched PubMed, PsycInfo, and CINAHL from 2002 to 2012 for studies of any research design that assessed the burden or frequency of psychological harm associated with screening for: prostate and lung cancers, osteoporosis, abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS). We also searched for studies that estimated rates of overdiagnosis (a marker for unnecessary labeling). We included studies published in English and used dual independent review to determine study inclusion and to abstract information on design, types of measures, and outcomes assessed. RESULTS: Sixty-eight studies assessing psychological harms met our criteria; 62 % concerned prostate cancer and 16 % concerned lung cancer. Evidence was scant for the other three screening services. Overall, only about one-third of the studies used both longitudinal designs and condition-specific measures (ranging from 0 % for AAA and CAS to 78 % for lung cancer), which can provide the best evidence on harms. An additional 20 studies that met our criteria estimated rates of overdiagnosis in lung or prostate cancer. No studies estimated overdiagnosis for the non-cancer screening services. DISCUSSION: Evidence on psychological harms varied markedly across screening services in number and potential usefulness. We found important evidence gaps for all five screening services. The evidence that we have on psychological harms is inadequate in number of studies and in research design and measures. Future research should focus more clearly on the evidence that we need for decision making about screening.

Process evaluation of an intervention to increase provision of adolescent vaccines at school health centers.

BACKGROUND: Vaccination programs in school health centers (SHCs) may improve adolescent vaccine coverage. We conducted a process evaluation of an intervention to increase SHC-located vaccination to better understand the feasibility and challenges of such interventions. METHOD: Four SHCs participated in an intervention to increase provision of recommended vaccines to 2,975 adolescents. We reviewed program materials and SHC staff reports, and interviewed parents to assess implementation fidelity and reactions to materials. RESULTS: Ten percent of parents returned forms with consent to at least one vaccine. Of these, 79% checked the box consenting for "all recommended" vaccines, rather than indicating individual vaccines. SHCs sent supplemental mailings to some parents that clarified (a) vaccination costs or (b) human papillomavirus vaccine recommendation for boys and required parents to reconsent. This process resulted in loss of initial consent, primarily due to nonresponse. In interviews, parents who consented to vaccination indicated that intervention materials were clear and persuasive, but needed greater detail about costs and clinic processes. CONCLUSIONS: With limited additional investment, it appears feasible for SHCs to achieve a modest increase in the number of vaccinated adolescents. Providing a checkbox to indicate global consent for all recommended vaccinations, and close collaboration among individuals involved in intervention development, may facilitate vaccination efforts.

The harms of screening: a proposed taxonomy and application to lung cancer screening.

IMPORTANCE: Making rational decisions about screening requires information about its harms, but high-quality evidence is often either not available or not used. One reason may be that we lack a coherent framework, a taxonomy, for conceptualizing and studying these harms. OBJECTIVE: To create a taxonomy, we categorized harms from several sources: systematic reviews of screening, other published literature, and informal discussions with clinicians and patients. We used this information to develop an initial taxonomy and vetted it with local and national experts, making revisions as needed. RESULTS: We propose a taxonomy with 4 domains of harm from screening: physical effects, psychological effects, financial strain, and opportunity costs. Harms can occur at any step of the screening cascade. We provide definitions for each harm domain and illustrate the taxonomy using the example of screening for lung cancer. CONCLUSIONS AND RELEVANCE: The taxonomy provides a systematic way to conceptualize harms as experienced by patients. As shown in the lung cancer screening example, the taxonomy also makes clear where (which domains of harms and which parts of the screening cascade) we have useful information and where there are gaps in our knowledge. The taxonomy needs further testing and validation across a broad range of screening programs. We hope that further development of this taxonomy can improve our thinking about the harms of screening, thus informing our research, policy making, and decision making with patients about the wisdom of screening.

Engaging in health behaviors to lower risk for breast cancer recurrence.

PURPOSE: While post-treatment breast cancer survivors face up to twice the cancer risk of the general population, modifiable health behaviors may somewhat reduce this risk. We sought to better understand health behaviors that early stage breast cancer survivors engage in to reduce recurrence risk. METHODS: Data came from a cross-sectional multi-site survey of 186 early-stage breast cancer survivors who received genomic testing for breast cancer recurrence risk (Oncotype DX) during their clinical care. Study outcomes were meeting health behavior recommendations (daily fruit and vegetable intake, regular physical activity, and having a healthy body mass index (BMI)). RESULTS: Approximately three-quarters of survivors we surveyed believed the 3 behaviors might reduce their cancer risk but many did not engage in these behaviors for this purpose: 62% for BMI, 36% for fruit and vegetable consumption, and 37% for physical activity. Survivors with higher recurrence risk, as indicated by their genomic test results, were no more likely to meet any of the three health behavior recommendations. Adherence to health behavior recommendations was higher for women who were white, college-educated, and had higher incomes. CONCLUSIONS: Many nonadherent breast cancer survivors wish to use these behavioral strategies to reduce their risk for recurrence, suggesting an important opportunity for intervention. Improving BMI, which has the largest association with cancer risk, is an especially promising target.

Understanding how breast cancer patients use risk information from genomic tests.

We sought to examine how patients' treatment decisions incorporate potentially conflicting information from standard clinical indicators (e.g., tumor size) and genomic tests for breast cancer recurrence risk. Participants were 77 early stage breast cancer survivors who previously received genomic testing. They read six hypothetical vignettes that varied recurrence risk indicated by standard tests (low or high risk) coupled with the genomic test (low, intermediate or high risk). For each vignette, women reported their perceived recurrence risk and treatment preferences. Test results indicating high recurrence risk increased perception of risk and preference for chemotherapy (p < .001 for all). Perceived risk explained (i.e., mediated) the effect of test results on chemotherapy preferences. When test results conflicted, women gave more weight to genomic over standard test results. Hypothetical genomic test results had the intended effect of influencing women's perceptions of recurrence risk and interest in chemotherapy.

Influence of false-positive mammography results on subsequent screening: do physician recommendations buffer negative effects?

OBJECTIVE: Cancer screening guidelines often include discussion about the unintended negative consequences of routine screening. This prospective study examined effects of false-positive mammography results on women's adherence to subsequent breast cancer screening and psychological well-being. We also assessed whether barriers to screening exacerbated the effects of false-positive results. METHODS: We conducted secondary analyses of data from telephone interviews and medical claims records for 2406 insured women. The primary outcome was adherence to screening guidelines, defined as adherent (10-14 months), delayed (15-34 months), or no subsequent mammogram on record. RESULTS: About 8% of women reported that their most recent screening mammograms produced false-positive results. In the absence of self-reported advice from their physicians to be screened, women were more likely to have no subsequent mammograms on record if they received false-positive results than if they received normal results (18% vs. 7%, OR = 3.17, 95% CI = 1.30, 7.70). Receipt of false-positive results was not associated with this outcome for women who said their physicians had advised regular screening in the past year (7% vs. 10%, OR = 0.74, 95% CI = 0.38, 1.45). False-positive results were associated with greater breast cancer worry (P < .01), thinking more about the benefits of screening (P < .001), and belief that abnormal test results do not mean women have cancer (P < .01), regardless of physicians' screening recommendations. CONCLUSION: False-positive mammography results, coupled with reports that women's physicians did not advise regular screening, could lead to non-adherence to future screening. Abnormal mammograms that do not result in cancer diagnoses are opportunities for physicians to stress the importance of regular screening.

Improving communication of breast cancer recurrence risk.

Doctors commonly use genomic testing for breast cancer recurrence risk. We sought to assess whether the standard genomic report provided to doctors is a good approach for communicating results to patients. During 2009-2010, we interviewed 133 patients with stages I or II, node-negative, hormone receptor-positive breast cancer and eligible for the Oncotype DX genomic test. In a randomized experiment, patients viewed six vignettes that presented hypothetical recurrence risk test results. Each vignette described a low, intermediate, or high chance of breast cancer recurrence in 10 years. Vignettes used one of five risk formats of increasing complexity that we derived from the standard report that accompanies the commercial assay or a sixth format that used an icon array. Among women who received the genomic recurrence risk test, 63% said their doctors showed them the standard report. The standard report format yielded among the most errors in identification of whether a result was low, intermediate, or high risk (i.e., the gist of the results), whereas a newly developed risk continuum format yielded the fewest errors (17% vs. 5%; OR 0.23; 95% CI 0.10-0.52). For high recurrence risk results presented in the standard format, women made errors 35% of the time. Women rated the standard report as one of the least understandable and least-liked formats, but they rated the risk continuum format as among the most understandable and most liked. Results differed little by health literacy, numeracy, prior receipt of genomic test results during clinical care, and actual genomic test results. The standard genomic recurrence risk report was more difficult for women to understand and interpret than the other formats. A less complex report, potentially including the risk continuum format, would be more effective in communicating test results to patients.

Finding the minimal intervention needed for sustained mammography adherence.

BACKGROUND: Regular adherence to mammography screening saves lives, yet few women receive regular mammograms. DESIGN: RCT. SETTING/PARTICIPANTS: Participants were recruited through a state employee health plan. All were women aged 40-75 years and had recent mammograms prior to enrollment (n=3547). Data were collected from 2004 to 2009. INTERVENTION: Trial tested efficacy of a two-step adaptively-designed intervention to increase mammography adherence over 4 years. The first intervention step consisted of three reminder types: enhanced usual care reminders (EUCR); enhanced letter reminders (ELR); both delivered by mail, and automated telephone reminders (ATR). After delivery of reminders, women who became off-schedule in any of the 4 years received a second step of supplemental interventions. Three supplemental intervention arms contained priming letters and telephone counseling: barriers only (BarriCall); barriers plus positive consequences of getting mammograms (BarriConCall+); and barriers plus negative consequences of not getting mammograms (BarriConCall-). MAIN OUTCOME MEASURES: Average cumulative number of days non-adherent to mammography over 4 years based on annual screening guidelines (analyses conducted in 2009). RESULTS: All reminders performed equally well in reducing number of days of non-adherence. Women randomized to receive supplemental interventions had significantly fewer days of non-adherence compared to women who received EUCR (p=0.0003). BarrConCall+ and BarrConCall- conditions did not significantly differ in days non-adherent compared to women in the barriers-only condition (BarriCon). CONCLUSIONS: The minimal intervention needed for sustained mammography use is a combination of a reminder followed by a priming letter and barrier-specific telephone counseling for women who become off-schedule. Additional costs associated with supplemental interventions should be considered by organizations deciding which interventions to use. TRIAL REGISTRATION NUMBER: NCT01148875.

A model of the influence of false-positive mammography screening results on subsequent screening.

Decades of empirical research have demonstrated psychological and behavioural consequences of false-positive medical tests. To organise this literature and offer novel predictions, we propose a model of how false-positive mammography results affect return for subsequent mammography screening. We propose that false-positive mammography results alter how women think about themselves (e.g., increasing their perceived likelihood of getting breast cancer) and the screening test (e.g., believing mammography test results are less accurate). We further hypothesise that thoughts elicited by the false-positive experience will, in turn, affect future use of screening mammography. In addition, we discuss methodological considerations for statistical analyses of these mediational pathways and propose two classes of potential moderators. While our model focuses on mammography screening, it may be applicable to psychological and behavioural responses to other screening tests. The model is especially timely as false-positive medical test results are increasingly common, due to efforts to increase uptake of cancer screening, new technologies that improve existing tests' ability to detect disease at the cost of increased false alarms, and growing numbers of new medical tests.

Factors associated with annual-interval mammography for women in their 40s.

BACKGROUND: Evidence is mounting that annual mammography for women in their 40s may be the optimal schedule to reduce morbidity and mortality from breast cancer. Few studies have assessed predictors of repeat mammography on an annual interval among these women. METHODS: We assessed mammography screening status among 596 insured Black and Non-Hispanic white women ages 43-49. Adherence was defined as having a second mammogram 10-14 months after a previous mammogram. We examined socio-demographic, medical and healthcare-related variables on receipt of annual-interval repeat mammograms. We also assessed barriers associated with screening. RESULTS: 44.8% of the sample were adherent to annual-interval mammography. A history of self-reported abnormal mammograms, family history of breast cancer and never having smoked were associated with adherence. Saying they had not received mammography reminders and reporting barriers to mammography were associated with non-adherence. Four barrier categories were associated with women's non-adherence: lack of knowledge/not thinking mammograms are needed, cost, being too busy, and forgetting to make/keep appointments. CONCLUSIONS: Barriers we identified are similar to those found in other studies. Health professionals may need to take extra care in discussing mammography screening risk and benefits due to ambiguity about screening guidelines for women in their 40s, especially for women without family histories of breast cancer or histories of abnormal mammograms. Reminders are important in promoting mammography and should be coupled with other strategies to help women maintain adherence to regular mammography.

Impact of mailed and automated telephone reminders on receipt of repeat mammograms: a randomized controlled trial.

BACKGROUND: This study compares the efficacy of three types of reminders in promoting annual repeat mammography screening. DESIGN: RCT. SETTING AND PARTICIPANTS: Study recruitment occurred in 2004-2005. Participants were recruited through the North Carolina State Health Plan for Teachers and State Employees. All were aged 40-75 years and had a screening mammogram prior to study enrollment. A total of 3547 women completed baseline telephone interviews. INTERVENTION: Prior to study recruitment, women were assigned randomly to one of three reminder groups: (1) printed enhanced usual care reminders (EUCRs); (2) automated telephone reminders (ATRs) identical in content to EUCRs; or (3) enhanced letter reminders that included additional information guided by behavioral theory. Interventions were delivered 2-3 months prior to women's mammography due dates. MAIN OUTCOME MEASURES: Repeat mammography adherence, defined as having a mammogram no sooner than 10 months and no later than 14 months after the enrollment mammogram. RESULTS: Each intervention produced adherence proportions that ranged from 72% to 76%. Post-intervention adherence rates increased by an absolute 17.8% from baseline. Women assigned to ATRs were significantly more likely to have had mammograms than women assigned to EUCRs (p=0.014). Comparisons of reminder efficacy did not vary across key subgroups. CONCLUSIONS: Although all reminders were effective in promoting repeat mammography adherence, ATRs were the most effective and lowest in cost. Health organizations should consider using ATRs to maximize proportions of members who receive mammograms at annual intervals.

Triangulating differential nonresponse by race in a telephone survey.

INTRODUCTION: In 1994, the U.S. Department of Health and Human Services mandated sufficient inclusion of racial and ethnic minorities in all federally funded research. This mandate requires researchers to monitor study samples for research participation and differential survey nonresponse. This study illustrates methods to assess differential survey nonresponse when population race data are incomplete, which is often the case when studies are conducted among members of health plans. METHODS: We collected data as part of the PRISM (Personally Relevant Information about Screening Mammography) study, a trial funded by the National Institutes of Health to increase rates of annual mammography adherence. We used two methods to estimate racial distribution of the PRISM study population. The first method, called E-Tech, estimated race of the sample frame by using individuals' names and zip codes. In the second method, we conducted interviews with a subsample of PRISM study refusals. We validated both estimation methods through comparisons with self-reported race. We used race information generated by E-Tech, interviewer estimates, and self-report to assess differential nonresponse in the PRISM study. RESULTS: The E-Tech method had moderate sensitivity (48%) in estimating race of black participants but higher specificity (97%) and positive predictive value (71%). The interviewer-estimation method had high sensitivity (100%), high specificity (95%), and moderate positive predictive value (80%). Black women were less likely than white women to be reached for study participation. CONCLUSION: There was slight differential nonresponse by race in the PRISM study. Techniques described here may be useful for assessing differential nonresponse in samples with incomplete data on race.

Body image dissatisfaction in cancer survivors.

PURPOSE/OBJECTIVES: To explore medical and psychosocial factors associated with body image dissatisfaction in male and female cancer survivors. DESIGN: Secondary data analysis from the American Cancer Society's Study of Cancer Survivors-II pilot survey. SETTING: Cancer survivors were identified through two state cancer registry databases. SAMPLE: 165 male and 234 female cancer survivors of six cancer types (bladder, female breast, colorectal, endometrial, prostate, and melanoma) who were 2, 5, and 10 years beyond diagnosis. METHODS: Researchers notified physicians prior to participant recruitment. State cancer registries contacted potential participants via mailed letters. Participants who gave their informed consent completed a written survey. MAIN RESEARCH VARIABLES: Current body image dissatisfaction, mental and physical health, sexual functioning, and basic medical and demographic information. FINDINGS: Results of multiple regression analysis indicated that male survivors of prostate cancer were more likely to express positive body images than men who had other types of cancer. A composite variable that included a history of cancer recurrence, multiple cancers, or metastatic cancer was the strongest predictor of body image dissatisfaction for female survivors. Body image was not associated with age, length of time since diagnosis, or general treatment type for either gender. CONCLUSIONS: Body image was associated with various medical and psychosocial factors, and the factors differed for male and female cancer survivors. IMPLICATIONS FOR NURSING: An understanding of factors associated with body image is essential for the nursing care of patients with cancer.