Variation of the prevalence of pediatric polypharmacy: A scoping review.

PURPOSE: To examine the range of prevalence of pediatric polypharmacy in literature through a scoping review, focusing on factors that contribute to its heterogeneity in order to improve the design and reporting of quality improvement, pharmacovigilance, and research studies. METHODS: We searched Ovid Medline, PubMed, EMBASE, CINAHL, Ovid PsycINFO, Cochrane CENTRAL, and Web of Science Core Collection databases for studies with concepts of children and polypharmacy, along with a hand search of the bibliographies of six reviews and 30 included studies. We extracted information regarding study design, disease conditions, and prevalence of polypharmacy. RESULTS: Two hundred eighty-four studies reported prevalence of polypharmacy. They were more likely to be conducted in North America (37.7%), published after 2010 (44.4%), cross-sectional (67.3%), in outpatient settings (59.5%). Prevalence ranged from 0.9% to 98.4%, median 39.7% (interquartile range [IQR] 22.0%-54.0%). Studies from Asia reported the highest median prevalence of 45.4% (IQR 27.3%-61.0%) while studies from North America reported the lowest median prevalence of 30.4% (IQR 14.7%-50.2%). Prevalence decreased over time: median 45.6% before 2001, 38.1% during 2001 to 2010, and 34% during 2011 to 2017. Studies involving children under 12 years had a higher median prevalence (46.9%) than adolescent studies (33.7%). Inpatient setting studies had a higher median prevalence (50.3%) than studies in outpatient settings (38.8%). Community level samples, higher number and duration of medications defining polypharmacy, and psychotropic medications were associated with lower prevalence. CONCLUSIONS: The prevalence of pediatric polypharmacy is high and variable. Studies reporting pediatric polypharmacy should account for context, design, polypharmacy definition, and medications evaluated.

Outcome measures in pediatric polypharmacy research: a scoping review.

INTRODUCTION: Various methods have been used to interpret the reports of pediatric polypharmacy across the literature. This is the first scoping review that explores outcome measures in pediatric polypharmacy research. OBJECTIVES: The aim of our study was to describe outcome measures assessed in pediatric polypharmacy research. METHODS: A search of electronic databases was conducted in July 2017, including Ovid Medline, PubMed, Elsevier Embase, Wiley Cochrane Central Register of Controlled Trials (CENTRAL), EBSCO CINAHL, Ovid PsyclNFO, Web of Science Core Collection, ProQuest Dissertations and Thesis A&I. Data were extracted about study characteristics and outcome measures, and also synthesized by harms or benefits mentioned. RESULTS: The search strategy initially identified 8169 titles and screened 4398 using the inclusion criteria after de-duplicating. After the primary screening, a total of 363 studies were extracted for the data analysis. Polypharmacy (prevalence) was identified as an outcome in 31.4% of the studies, prognosis-related outcomes in 25.6%, and adverse drug reactions in 16.5%. A total of 265 articles (73.0%) mentioned harms, including adverse drug reactions (26.4%), side effects (24.2%), and drug-drug interactions (20.9%). A total of 83 studies (22.9%) mentioned any benefit, 48.2% of which identified combination for efficacy, 24.1% combination for treatment of complex diseases, and 19.3% combination for treatment augmentation. Thirty-eight studies reported adverse drug reaction as an outcome, where polypharmacy was a predictor, with various designs. CONCLUSIONS: Most studies of pediatric polypharmacy evaluate prevalence, prognosis, or adverse drug reaction-related out-comes, and underscore harms related to polypharmacy. Clinicians should carefully weigh benefits and harms when introducing medications to treatment regimens.

Defining pediatric polypharmacy: A scoping review.

OBJECTIVES: Lack of consensus regarding the semantics and definitions of pediatric polypharmacy challenges researchers and clinicians alike. We conducted a scoping review to describe definitions and terminology of pediatric polypharmacy. METHODS: Medline, PubMed, EMBASE, CINAHL, PsycINFO, Cochrane CENTRAL, and the Web of Science Core Collection databases were searched for English language articles with the concepts of "polypharmacy" and "children". Data were extracted about study characteristics, polypharmacy terms and definitions from qualifying studies, and were synthesized by disease conditions. RESULTS: Out of 4,398 titles, we included 363 studies: 324 (89%) provided numeric definitions, 131 (36%) specified duration of polypharmacy, and 162 (45%) explicitly defined it. Over 81% (n = 295) of the studies defined polypharmacy as two or more medications or therapeutic classes. The most common comprehensive definitions of pediatric polypharmacy included: two or more concurrent medications for ≥1 day (n = 41), two or more concurrent medications for ≥31 days (n = 15), and two or more sequential medications over one year (n = 12). Commonly used terms included polypharmacy, polytherapy, combination pharmacotherapy, average number, and concomitant medications. The term polypharmacy was more common in psychiatry literature while epilepsy literature favored the term polytherapy. CONCLUSIONS: Two or more concurrent medications, without duration, for ≥1 day, ≥31 days, or sequentially for one year were the most common definitions of pediatric polypharmacy. We recommend that pediatric polypharmacy studies specify the number of medications or therapeutic classes, if they are concurrent or sequential, and the duration of medications. We propose defining pediatric polypharmacy as "the prescription or consumption of two or more distinct medications for at least one day". The term "polypharmacy" should be included among key words and definitions in manuscripts.

A transdisciplinary team approach to scoping reviews: the case of pediatric polypharmacy.

BACKGROUND: Polypharmacy can be either beneficial or harmful to children. We conducted a scoping review to examine the concept of pediatric polypharmacy: its definition, prevalence, extent and gaps in research. In this manuscript, we report our transdisciplinary scoping review methodology. METHODS: After establishing a transdisciplinary team, we iteratively developed standard operating procedures for the study's search strategy, inclusion/exclusion criteria, screening, and data extraction. We searched eight bibliographic databases, screened abstracts and full text articles, and extracted data from included studies using standardized forms. We held regular team meetings and performed ongoing internal validity measurements to maintain consistent and quality outputs. RESULTS: With the aid of EPPI Reviewer collaborative software, our transdisciplinary team of nine members performed dual reviews of 363 included studies after dual screening of 4398 abstracts and 1082 full text articles. We achieved overall agreement of 85% and a kappa coefficient of 0.71 (95% CI 0.68-0.74) while screening full text articles. The screening and review processes required about seven hours per extracted study. The two pharmacists, an epidemiologist, a neurologist, and a librarian on the review team provided internal consultation in these key disciplines. A stakeholder group of 10 members with expertise in evidence synthesis, research implementation, pediatrics, mental health, epilepsy, pharmacoepidemiology, and pharmaceutical outcomes were periodically consulted to further characterize pediatric polypharmacy. CONCLUSIONS: A transdisciplinary approach to scoping reviews, including internal and external consultation, should be considered when addressing complex cross-disciplinary questions.

Are Providers Prepared to Engage Younger Women in Shared Decision-Making for Mammography?

BACKGROUND: The U.S. Preventive Services Task Force recommends providers engage women aged 40-49 years in shared decision-making (SDM) for mammography. This requires mammography knowledge, adequate time to discuss screening, and self-confidence in doing so. Yet, to date, no studies have assessed provider readiness to engage younger women in SDM. METHODS: An online survey of primary care providers was conducted in Cleveland in 2015. It inquired about knowledge of screening benefits and harms, including the impact of screening on mortality, risk of additional imaging, biopsy, overtreatment following screening, and likelihood of a true-positive result. Key knowledge was defined as accurate estimation of the impact of screening on mortality and risk of overtreatment. Respondents reported time typically spent with patients discussing mammography, self-assessed competence in engaging patients in screening discussions, and perspectives on SDM for mammography. RESULTS: Of 612 providers invited, 220 completed the survey (response rate: 36%). Knowledge of harms was low: 90% and 82% underestimated the risk of additional imaging or breast biopsy, respectively. Sixty-two percent correctly estimated screening's impact on mortality. The majority (83%) believed in SDM for mammography, yet, most (77%) spent less than 5 minutes with patients discussing screening. Of those who believed in SDM, only 10% had key mammography knowledge and also felt highly competent at engaging women in screening discussions. CONCLUSIONS: Most providers in our sample were inadequately equipped to engage women in SDM for mammography. Broad-based efforts are needed to increase the capacity of providers to engage younger women in decision-making.

Factors Associated with Routine Recommendation of Mammography for Women Aged 40-49: Provider Characteristics and Screening Influences.

OBJECTIVES: Despite the US Preventive Services Task Force recommendation against screening mammography in women younger than 50 years, rates remain high, suggesting that screening recommendations may be motivated by other factors. The objective of this study was to understand provider-reported influences on screening recommendations for women 40 to 49 years old at average risk for breast cancer. METHODS: An online survey of primary care providers was conducted at four health centers in Cleveland, Ohio in 2015. Provider-reported routine recommendation of mammography for women aged 40 to 49 at average risk for breast cancer was the primary outcome. The independent measures included influence of electronic health records, national guidelines, institutional policy, patient preferences, concerns about overtreatment, concerns about false-positives, and interest in early detection on screening recommendations. We used multivariable logistic regression to estimate the odds of recommending screening by potential influences, controlling for provider characteristics and provider-assessed balance of harms and benefits of screening in this age group. RESULTS: Of 612 providers invited, 220 completed the survey (response rate 36%); 69% routinely recommended screening and 24% believed that the harms of screening in younger women outweighed the benefits. Being influenced by institutional policy was associated with higher odds of recommending screening (odds ratio [OR] 4.19, 95% confidence interval [CI] 1.35-12.9), as was interest in early detection (OR 4.19, 95% CI 1.31-12.9). Conversely, strong influence of national guidelines was associated with a lower odds of recommending screening (OR 0.25, 95% CI 0.09-0.71). The influence of patient preferences was not associated with screening recommendation. CONCLUSIONS: Providers face competing influences on screening recommendations for younger patients, some of which may be at odds with their beliefs. Institutional policy change allowing individually tailored screening discussions may improve patient-centered care.

Impact of bariatric surgery on health care costs of obese persons: a 6-year follow-up of surgical and comparison cohorts using health plan data.

IMPORTANCE: Bariatric surgery is a well-documented treatment for obesity, but there are uncertainties about the degree to which such surgery is associated with health care cost reductions that are sustained over time. OBJECTIVE: To provide a comprehensive, multiyear analysis of health care costs by type of procedure within a large cohort of privately insured persons who underwent bariatric surgery compared with a matched nonsurgical cohort. DESIGN: Longitudinal analysis of 2002-2008 claims data comparing a bariatric surgery cohort with a matched nonsurgical cohort. SETTING: Seven BlueCross BlueShield health insurance plans with a total enrollment of more than 18 million persons. PARTICIPANTS: A total of 29 820 plan members who underwent bariatric surgery between January 1, 2002, and December 31, 2008, and a 1:1 matched comparison group of persons not undergoing surgery but with diagnoses closely associated with obesity. MAIN OUTCOME MEASURES: Standardized costs (overall and by type of care) and adjusted ratios of the surgical group's costs relative to those of the comparison group. RESULTS: Total costs were greater in the bariatric surgery group during the second and third years following surgery but were similar in the later years. However, the bariatric group's prescription and office visit costs were lower and their inpatient costs were higher. Those undergoing laparoscopic surgery had lower costs in the first few years after surgery, but these differences did not persist. CONCLUSIONS AND RELEVANCE: Bariatric surgery does not reduce overall health care costs in the long term. Also, there is no evidence that any one type of surgery is more likely to reduce long-term health care costs. To assess the value of bariatric surgery, future studies should focus on the potential benefit of improved health and well-being of persons undergoing the procedure rather than on cost savings.

Body mass index and colon cancer screening: a systematic review and meta-analysis.

BACKGROUND: Obesity is associated with increased colon cancer mortality and lower rates of mammography and Pap testing. METHODS: We conducted a systematic review to determine whether obesity is associated with lower rates of colon cancer screening. We searched the PubMed, CINAHL, and Cochrane Library databases. Two investigators reviewed citations, abstracts, and articles independently. Two investigators abstracted study information sequentially and evaluated quality independently using standardized forms. We included all studies in our qualitative syntheses. We used random effects meta-analyses to combine those studies providing screening results by the following body mass index (BMI) categories: Normal, 18.5-24.9 kg/m(2) (reference); overweight, 25-29.9 kg/m(2); class I obesity, 30-34.9 kg/m(2); class II obesity, 35-39.9 kg/m(2); and class III obesity, ≥ 40 kg/m(2). RESULTS: Of 5,543 citations, we included 23 articles. Almost all studies were cross-sectional and ascertained BMI and screening through self-report. BMI was not associated with colon cancer screening overall. The subgroup of obese white women reported lower rates of colon cancer screening compared with those with a normal BMI with combined ORs (95% CI) of 0.87 (0.82-0.93), 0.80 (0.65-0.99), and 0.73 (0.58-0.94) for class I, II, and III obesity, respectively. Results were similar among white men with class II obesity. CONCLUSIONS: Overall, BMI was not associated with colon cancer screening. Obese white men and women may be less likely to undergo colon cancer screening compared with those with a normal BMI. IMPACT: Further investigation of this disparity may reduce the risk of obesity-related colon cancer death.

Clinical outcomes after bariatric surgery: a five-year matched cohort analysis in seven US states.

BACKGROUND: Bariatric surgery is the most effective weight loss treatment, yet few studies have reported on short- and long-term outcomes postsurgery. METHODS: Using claims data from seven Blue Cross/Blue Shield health plans serving seven states, we conducted a non-concurrent, matched cohort study. We followed 22,693 persons who underwent bariatric surgery during 2003-2007 and were enrolled at least 6 months before and after surgery. Using logistic regression, we compared serious and less serious adverse clinical outcomes, hospitalizations, planned procedures, and obesity-related co-morbidities between groups for up to 5 years. RESULTS: Relative to controls, surgery patients were more likely to experience a serious [odds ratio (OR) 1.9; 95% confidence interval (CI) 1.8-2.0] or less serious (OR 2.5, CI 2.4-2.7) adverse clinical outcome or hospitalization (OR 1.3, CI 1.3-1.4) at 1 year postsurgery. The risk remained elevated until 4 years postsurgery for serious events and 5 years for less serious outcomes and hospitalizations. Some complication rates were lower for patients undergoing laparoscopic surgery. Planned procedures, such as skin reduction, peaked in postsurgery year 2 but remained elevated through year 5. Surgery patients had a 55% decreased risk of obesity-related co-morbidities, such as type 2 diabetes, in the first year postsurgery, which remained low throughout the study (year 5: OR 0.4, CI 0.4-0.5). CONCLUSIONS: While bariatric surgery is associated with a higher risk of adverse clinical outcomes compared to controls, it also substantially decreased obesity-related co-morbidities during the 5-year follow-up.

Development of a claims-based risk score to identify obese individuals.

Obesity is underdiagnosed, hampering system-based health promotion and research. Our objective was to develop and validate a claims-based risk model to identify obese persons using medical diagnosis and prescription records. We conducted a cross-sectional analysis of de-identified claims data from enrollees of 3 Blue Cross Blue Shield plans who completed a health risk assessment capturing height and weight. The final sample of 71,057 enrollees was randomly split into 2 subsamples for development and validation of the obesity risk model. Using the Johns Hopkins Adjusted Clinical Groups case-mix/predictive risk methodology, we categorized study members' diagnosis (ICD) codes. Logistic regression was used to determine which claims-based risk markers were associated with a body mass index (BMI) > or = 35 kg/m(2). The sensitivities of the scores > or =90(th) percentile to detect obesity were 26% to 33%, while the specificities were >90%. The areas under the receiver operator curve ranged from 0.67 to 0.73. In contrast, a diagnosis of obesity or an obesity medication alone had very poor sensitivity (10% and 1%, respectively); the obesity risk model identified an additional 22% of obese members. Varying the percentile cut-point from the 70(th) to the 99(th) percentile resulted in positive predictive values ranging from 15.5 to 59.2. An obesity risk score was highly specific for detecting a BMI > or = 35 kg/m(2) and substantially increased the detection of obese members beyond a provider-coded obesity diagnosis or medication claim. This model could be used for obesity care management and health promotion or for obesity-related research.

Obesity and mammography: a systematic review and meta-analysis.

BACKGROUND: Obese women experience higher postmenopausal breast cancer risk, morbidity, and mortality and may be less likely to undergo mammography. OBJECTIVES: To quantify the relationship between body weight and mammography in white and black women. DATA SOURCES AND REVIEW METHODS: We identified original articles evaluating the relationship between weight and mammography in the United States through electronic and manual searching using terms for breast cancer screening, breast cancer, and body weight. We excluded studies in special populations (e.g., HIV-positive patients) or not written in English. Citations and abstracts were reviewed independently. We abstracted data sequentially and quality information independently. RESULTS: Of 5,047 citations, we included 17 studies in our systematic review. Sixteen studies used self-reported body mass index (BMI) and excluded women <40 years of age. Using random-effects models for the six nationally representative studies using standard BMI categories, the combined odds ratios (95% CI) for mammography in the past 2 years were 1.01 (0.95 to 1.08), 0.93 (0.83 to 1.05), 0.90 (0.78 to 1.04), and 0.79 (0.68 to 0.92) for overweight (25-29.9 kg/m(2)), class I (30-34.9 kg/m(2)), class II (35-39.9 kg/m(2)), and class III (> or =40 kg/m(2)) obese women, respectively, compared to normal-weight women. Results were consistent when all available studies were included. The inverse association was found in white, but not black, women in the three studies with results stratified by race. CONCLUSIONS: Morbidly obese women are significantly less likely to report recent mammography. This relationship appears stronger in white women. Lower screening rates may partly explain the higher breast cancer mortality in morbidly obese women.

The association of obesity and cervical cancer screening: a systematic review and meta-analysis.

Obese women are at an increased risk of death from cervical cancer, but the explanation for this is unknown. Through our systematic review, we sought to determine whether obesity is associated with cervical cancer screening and whether this association differs by race. We identified original articles evaluating the relationship between body weight and Papanicolaou (Pap) testing in the United States through electronic (PubMed, CINAHL, and the Cochrane Library) and manual searching. We excluded studies in special populations or those not written in English. Two reviewers sequentially extracted study data and independently extracted quality using standardized forms. A total of 4,132 citations yielded 11 relevant studies. Ten studies suggested an inverse association between obesity and cervical cancer screening. Compared to women with a normal BMI, the combined odds ratios (95% CI) for Pap testing were 0.91 (0.80-1.03), 0.81 (0.70-0.93), 0.75 (0.64-0.88), and 0.62 (0.55-0.69) for the overweight and class I, class II, and class III obesity categories, respectively. Three out of four studies that presented the results by race found this held true for white women, but no study found this for black women. In conclusion, obese women are less likely to report being screened for cervical cancer than their lean counterparts, and this does not hold true for black women. Less screening may partly explain the higher cervical cancer mortality seen in obese white women.

Failure to intensify antihypertensive treatment by primary care providers: a cohort study in adults with diabetes mellitus and hypertension.

BACKGROUND: Although tight blood pressure control is crucial in reducing vascular complications of diabetes, primary care providers often fail to appropriately intensify antihypertensive medications. OBJECTIVE: To identify novel visit-based factors associated with intensification of antihypertensive medications in adults with diabetes. DESIGN: Non-concurrent prospective cohort study. PATIENTS: A total of 254 patients with type 2 diabetes and hypertension enrolled in an academically affiliated managed care program. Over a 24-month interval (1999-2001), we identified 1,374 visits at which blood pressure was suboptimally controlled (systolic BP >/= 140 mmHg or diastolic BP >/= 90 mmHg). MEASUREMENTS AND MAIN RESULTS: Intensification of antihypertensive medications at each visit was the primary outcome. Primary care providers intensified antihypertensive treatment in only 176 (13%) of 1,374 visits at which blood pressure was elevated. As expected, higher mean systolic and mean diastolic blood pressures were important predictors of intensification. Treatment was also more likely to be intensified at visits that were "routine" odds ratio (OR) 2.08; 95% Confidence Interval [95% CI] 1.36-3.18), or that paired patients with their usual primary care provider (OR 1.84; 95% CI 1.11-3.06). In contrast, several factors were associated with failure to intensify treatment, including capillary glucose >150 mg/dL (OR 0.54; 95% CI 0.31-0.94) and the presence of coronary heart disease (OR 0.61; 95% CI 0.38-0.95). Co-management by a cardiologist accounted partly for this failure (OR 0.65; 95% CI 0.41-1.03). CONCLUSIONS: Failure to appropriately intensify antihypertensive treatment is common in diabetes care. Clinical distractions and shortcomings in continuity and coordination of care are possible targets for improvement.

Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review.

Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. The authors conducted a systematic review to determine the barriers to participation of underrepresented populations in cancer-related trials. Their search included English-language publications that reported original data on the recruitment of underrepresented groups to cancer treatment or prevention trials between 1966 and December 2005 in multiple electronic databases. They also hand-searched titles in 34 journals from January 2003 to December 2005 and they examined reference lists for eligible articles. Titles and abstracts were reviewed to identify relevant studies. Data on barriers to participation were synthesized both qualitatively and based on statistically significant associations with trial enrollment. Of 5257 studies that were cited, 65 studies were eligible for inclusion in the current analysis, including 46 studies on recruitment into cancer therapeutic trials, 15 studies on recruitment into prevention trials, and 4 studies on recruitment into both prevention and treatment trials. Numerous factors were reported as barriers to participation in cancer-related trials. However, only 20 of the studies reported statistically significant associations between hypothesized barriers and enrollment. The available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data-collection methods, potential for bias, and data analysis. The results indicated that underrepresented populations face numerous barriers to participation in cancer-related trials. The current systematic review highlighting the literature on recruitment of underrepresented populations to cancer trials and may be used as the evidence base toward developing an agenda for etiologic and intervention research to reduce the disparities in participation in cancer-related trials.

Provider roles in the recruitment of underrepresented populations to cancer clinical trials.

BACKGROUND: Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider-related factors influencing recruitment of underrepresented populations to cancer clinical trials. METHODS: To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand-searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators. RESULTS: Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case-control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study. CONCLUSIONS: A heterogeneous body of evidence suggests that several provider-related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors.

Beyond cardiovascular risk: the impact of obesity on cancer death.

Obesity is associated with higher rates of death due to cancer. Possible explanations for this association include physiological factors associated with obesity, lower cancer screening rates in obese people, and technical difficulties in treating obese patients. These problems represent opportunities to improve the care of obese patients.

Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials.

BACKGROUND: Certain populations, including racial and ethnic minorities and older persons, have had a history of low participation in cancer-related trials, yet there has been little information reported on recruitment strategies tailored to improve their enrollment. METHODS: We conducted a systematic literature review to examine the methods used to study recruitment of underrepresented populations into cancer prevention and treatment trials and examined the studies that compared the efficacy and/or effectiveness of different recruitment strategies. We performed an electronic search through multiple databases including PubMed and a hand search of 34 journals. Potential studies were pulled and underwent title, abstract, and article review by at least two investigators. RESULTS: Fourteen articles examined recruitment of underrepresented populations into cancer trials and, of these, five compared efficacy or effectiveness of different strategies for recruitment of underrepresented populations into randomized or concurrent controlled trials. These five studies used various strategies but only three reported that specific recruitment strategies, such as media campaigns and church-based project sessions, resulted in improvement in accrual to cancer trials. CONCLUSION: There is limited evidence for efficacious or effective strategies to recruit underrepresented populations in cancer-related trials. The available evidence cannot be generalized to these heterogeneous groups. Further study is needed on efficacious strategies for recruitment of underrepresented populations into cancer-related trials.

Defining "success" in recruitment of underrepresented populations to cancer clinical trials: moving toward a more consistent approach.

Although medically underserved groups bear a heavy burden of cancer disease and governmental agencies have required inclusion of minorities and women in cancer clinical trials since 1993, many of these groups are underrepresented in cancer prevention or treatment clinical trials. To assess and enhance recruitment of underrepresented populations into cancer-related clinical trials, investigators and governmental agencies need consistent measurement approaches for recruitment that can be applied to diverse settings where trials are conducted. We conducted a systematic review to evaluate what measurement approaches were used to evaluate the success of recruitment of underrepresented groups into cancer prevention or treatment trials, and whether these recruitment goals were stated a priori. Only two articles reported an a priori recruitment goal. The recruitment measurement approaches varied considerably, with no consistent standard, especially for individual trials. By using the empiric evidence from this review in conjunction with the National Institutes of Health (NIH) guidelines, we constructed a framework for choosing consistent a priori recruitment goals for underrepresented groups based on the research question and study location. Using consistent measurement approaches for underrepresented groups will improve comparability of recruitment strategies across trials, improve equity in distribution of benefits and burdens of cancer-related clinical trials, and may improve applicability of trial results to multiple populations.