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1.  Facilitating the Recruitment of Minority Ethnic People into Research: Qualitative Case Study of South Asians and Asthma 
PLoS Medicine  2009;6(10):e1000148.
Aziz Sheikh and colleagues report on a qualitative study in the US and the UK to investigate ways to bolster recruitment of South Asians into asthma studies, including making inclusion of diverse populations mandatory.
There is international interest in enhancing recruitment of minority ethnic people into research, particularly in disease areas with substantial ethnic inequalities. A recent systematic review and meta-analysis found that UK South Asians are at three times increased risk of hospitalisation for asthma when compared to white Europeans. US asthma trials are far more likely to report enrolling minority ethnic people into studies than those conducted in Europe. We investigated approaches to bolster recruitment of South Asians into UK asthma studies through qualitative research with US and UK researchers, and UK community leaders.
Methods and Findings
Interviews were conducted with 36 researchers (19 UK and 17 US) from diverse disciplinary backgrounds and ten community leaders from a range of ethnic, religious, and linguistic backgrounds, followed by self-completion questionnaires. Interviews were digitally recorded, translated where necessary, and transcribed. The Framework approach was used for analysis. Barriers to ethnic minority participation revolved around five key themes: (i) researchers' own attitudes, which ranged from empathy to antipathy to (in a minority of cases) misgivings about the scientific importance of the question under study; (ii) stereotypes and prejudices about the difficulties in engaging with minority ethnic populations; (iii) the logistical challenges posed by language, cultural differences, and research costs set against the need to demonstrate value for money; (iv) the unique contexts of the two countries; and (v) poorly developed understanding amongst some minority ethnic leaders of what research entails and aims to achieve. US researchers were considerably more positive than their UK counterparts about the importance and logistics of including ethnic minorities, which appeared to a large extent to reflect the longer-term impact of the National Institutes of Health's requirement to include minority ethnic people.
Most researchers and community leaders view the broadening of participation in research as important and are reasonably optimistic about the feasibility of recruiting South Asians into asthma studies provided that the barriers can be overcome. Suggested strategies for improving recruitment in the UK included a considerably improved support structure to provide academics with essential contextual information (e.g., languages of particular importance and contact with local gatekeepers), and the need to ensure that care is taken to engage with the minority ethnic communities in ways that are both culturally appropriate and sustainable; ensuring reciprocal benefits was seen as one key way of avoiding gatekeeper fatigue. Although voluntary measures to encourage researchers may have some impact, greater impact might be achieved if UK funding bodies followed the lead of the US National Institutes of Health requiring recruitment of ethnic minorities. Such a move is, however, likely in the short- to medium-term, to prove unpopular with many UK academics because of the added “hassle” factor in engaging with more diverse populations than many have hitherto been accustomed to.
Please see later in the article for the Editors' Summary
Editors' Summary
In an ideal world, everyone would have the same access to health care and the same health outcomes (responses to health interventions). However, health inequalities—gaps in health care and in health between different parts of the population—exist in many countries. In particular, people belonging to ethnic minorities in the UK, the US, and elsewhere have poorer health outcomes for several conditions than people belonging to the ethnic majority (ethnicity is defined by social characteristics such as cultural tradition or national origin). For example, in the UK, people whose ancestors came from the Indian subcontinent (also known as South Asians and comprising in the main of people of Indian, Pakistani, and Bangladeshi origin) are three times as likely to be admitted to hospital for asthma as white Europeans. The reasons underpinning ethnic health inequalities are complex. Some inequalities may reflect intrinsic differences between groups of people—some ethnic minorities may inherit genes that alter their susceptibility to a specific disease. Other ethnic health inequalities may arise because of differences in socioeconomic status or because different cultural traditions affect the uptake of health care services.
Why Was This Study Done?
Minority ethnic groups are often under-represented in health research, which could limit the generalizability of research findings. That is, an asthma treatment that works well in a trial where all the participants are white Europeans might not be suitable for South Asians. Clinicians might nevertheless use the treatment in all their patients irrespective of their ethnicity and thus inadvertently increase ethnic health inequality. So, how can ethnic minorities be encouraged to enroll into research studies? In this qualitative study, the investigators try to answer this question by talking to US and UK asthma researchers and UK community leaders about how they feel about enrolling ethnic minorities into research studies. The investigators chose to compare the feelings of US and UK asthma researchers because minority ethnic people are more likely to enroll into US asthma studies than into UK studies, possibly because the US National Institute of Health's (NIH) Revitalization Act 1993 mandates that all NIH-funded clinical research must include people from ethnic minority groups; there is no similar mandatory policy in the UK.
What Did the Researchers Do and Find?
The investigators interviewed 16 UK and 17 US asthma researchers and three UK social researchers with experience of working with ethnic minorities. They also interviewed ten community leaders from diverse ethnic, religious and linguistic backgrounds. They then analyzed the interviews using the “Framework” approach, an analytical method in which qualitative data are classified and organized according to key themes and then interpreted. By comparing the data from the UK and US researchers, the investigators identified several barriers to ethnic minority participation in health research including: the attitudes of researchers towards the scientific importance of recruiting ethnic minority people into health research studies; prejudices about the difficulties of including ethnic minorities in health research; and the logistical challenges posed by language and cultural differences. In general, the US researchers were more positive than their UK counterparts about the importance and logistics of including ethnic minorities in health research. Finally, the investigators found that some community leaders had a poor understanding of what research entails and about its aims.
What Do These Findings Mean?
These findings reveal a large gap between US and UK researchers in terms of policy, attitudes, practices, and experiences in relation to including ethnic minorities in asthma research. However, they also suggest that most UK researchers and community leaders believe that it is both important and feasible to increase the participation of South Asians in asthma studies. Although some of these findings may have been affected by the study participants sometimes feeling obliged to give “politically correct” answers, these findings are likely to be generalizable to other diseases and to other parts of Europe. Given their findings, the researchers warn that a voluntary code of practice that encourages the recruitment of ethnic minority people into health research studies is unlikely to be successful. Instead, they suggest, the best way to increase the representation of ethnic minority people in health research in the UK might be to follow the US lead and introduce a policy that requires their inclusion in such research.
Additional Information
Please access these Web sites via the online version of this summary at
Families USA, a US nonprofit organization that campaigns for high-quality, affordable health care for all Americans, has information about many aspects of minority health in the US, including an interactive game about minority health issues
The US Agency for Healthcare Research and Quality has a section on minority health
The UK Department of Health provides information on health inequalities and a recent report on the experiences of patients in Black and minority ethnic groups
The UK Parliamentary Office of Science and Technology also has a short article on ethnicity and health
Information on the NIH Revitalization Act 1993 is available
NHS Evidences Ethnicity and Health has a variety of policy, clinical, and research resources on ethnicity and health
PMCID: PMC2752116  PMID: 19823568
2.  Professional Uncertainty and Disempowerment Responding to Ethnic Diversity in Health Care: A Qualitative Study 
PLoS Medicine  2007;4(11):e323.
While ethnic disparities in health and health care are increasing, evidence on how to enhance quality of care and reduce inequalities remains limited. Despite growth in the scope and application of guidelines on “cultural competence,” remarkably little is known about how practising health professionals experience and perceive their work with patients from diverse ethnic communities. Using cancer care as a clinical context, we aimed to explore this with a range of health professionals to inform interventions to enhance quality of care.
Methods and Findings
We conducted a qualitative study involving 18 focus groups with a purposeful sample of 106 health professionals of differing disciplines, in primary and secondary care settings, working with patient populations of varying ethnic diversity in the Midlands of the UK. Data were analysed by constant comparison and we undertook processes for validation of analysis. We found that, as they sought to offer appropriate care, health professionals wrestled with considerable uncertainty and apprehension in responding to the needs of patients of ethnicities different from their own. They emphasised their perceived ignorance about cultural difference and were anxious about being culturally inappropriate, causing affront, or appearing discriminatory or racist. Professionals' ability to think and act flexibly or creatively faltered. Although trying to do their best, professionals' uncertainty was disempowering, creating a disabling hesitancy and inertia in their practice. Most professionals sought and applied a knowledge-based cultural expertise approach to patients, though some identified the risk of engendering stereotypical expectations of patients. Professionals' uncertainty and disempowerment had the potential to perpetuate each other, to the detriment of patient care.
This study suggests potential mechanisms by which health professionals may inadvertently contribute to ethnic disparities in health care. It identifies critical opportunities to empower health professionals to respond more effectively. Interventions should help professionals acknowledge their uncertainty and its potential to create inertia in their practice. A shift away from a cultural expertise model toward a greater focus on each patient as an individual may help.
From a qualitative study, Joe Kai and colleagues have identified opportunities to empower health professionals to respond more effectively to challenges in their work with patients from diverse ethnic communities.
Editors' Summary
Communities are increasingly diverse in terms of ethnicity (belonging to a group of people defined by social characteristics such as cultural tradition or national origin) and race (belonging to a group identified by inherited physical characteristics). Although health professionals and governments are striving to ensure that everybody has the same access to health care, there is increasing evidence of ethnic inequalities in health-care outcomes. Some of these inequalities reflect intrinsic differences between groups of people—Ashkenazi Jews, for example, often carry an altered gene that increases their chance of developing aggressive breast cancer. Often, however, these differences reflect inequalities in the health care received by different ethnic groups. To improve this situation, “cultural competence” has been promoted over recent years. Cultural competence is the development of skills by individuals and organizations that allow them to work effectively with people from different cultures. Health professionals are now taught about ethnic differences in health beliefs and practices, religion, and communication styles to help them provide the best service to all their patients.
Why Was This Study Done?
Numerous guidelines aim to improve cultural competency but little is known about how health professionals experience and perceive their work with patients from diverse ethnic groups. Is their behavior influenced by ethnicity in ways that might contribute to health care disparities? For example, do doctors sometimes avoid medical examinations for fear of causing offence because of cultural differences? If more were known about how health professionals handle ethnic diversity (a term used here to include both ethnicity and race) it might be possible to reduce ethnic inequalities in health care. In this qualitative study, the researchers have explored how health professionals involved in cancer care are affected by working with ethnically diverse patients. A qualitative study is one that collects nonquantitative data such as how doctors “feel” about treating people of different ethnic backgrounds; a quantitative study might compare clinical outcomes in different ethnic groups.
What Did the Researchers Do and Find?
The researchers enrolled 106 doctors, nurses, and other health-related professionals from different health-service settings in the Midlands, an ethnically diverse region of the UK. They organized 18 focus groups in which the health professionals described their experiences of caring for people from ethnic minority backgrounds. The participants were encouraged to recall actual cases and to identify what they saw as problems and strengths in their interactions with these patients. The researchers found that the health professionals wrestled with many challenges when providing health care for patients from diverse ethnic backgrounds. These challenges included problems with language and with general communication (for example, deciding when it was acceptable to touch a patient to show empathy). Health professionals also worried they did not know enough about cultural differences. As a result, they said they often felt uncertain of their ability to avoid causing affront or appearing racist. This uncertainty, the researchers report, disempowered the health professionals, sometimes making them hesitate or fail to do what was best for their patient.
What Do These Findings Mean?
These findings reveal that health professionals often experience considerable uncertainty when caring for ethnically diverse patients, even after training in cultural competency. They also show that this uncertainty can lead to hesitancy and inertia, which might contribute to ethnic health care inequalities. Because the study participants were probably already interested in ethnic diversity and health care, interviews with other health professionals (and investigations of patient experiences) are needed to confirm these findings. Nevertheless, the researchers suggest several interventions that might reduce health care inequalities caused by ethnic diversity. For example, health professionals should be encouraged to recognize their uncertainty and should have access to more information and training about ethnic differences. In addition, there should be a shift in emphasis away from relying on knowledge-based cultural information towards taking an “ethnographic” approach. In other words, health professionals should be helped to feel able to ask their patients about what matters most to them as individuals about their illness and treatment.
Additional Information.
Please access these Web sites via the online version of this summary at
Information on cultural competence and health care is available from the US National Center for Cultural Competence (in English and Spanish) and DiversityRx
PROCEED (Professionals Responding to Cancer in Ethnic Diversity) is a multimedia training tool for educators within the health and allied professions developed from the results of this study; a press release on PROCEED is available from the University of Nottingham
Transcultural Health Care Practice: An educational resource for nurses and health care practitioners is available on the web site of the UK Royal College of Nursing
PMCID: PMC2071935  PMID: 18001148
3.  Community-Based Care for the Management of Type 2 Diabetes 
Executive Summary
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry’s newly released Diabetes Strategy.
After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.
To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site,,
Diabetes Strategy Evidence Platform: Summary of Evidence-Based Analyses
Continuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis
Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis
Bariatric Surgery for People with Diabetes and Morbid Obesity: An Evidence-Based Summary
Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis
Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis
Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario
The objective of this report is to determine the efficacy of specialized multidisciplinary community care for the management of type 2 diabetes compared to usual care.
Clinical Need: Target Population and Condition
Diabetes (i.e. diabetes mellitus) is a highly prevalent chronic metabolic disorder that interferes with the body’s ability to produce or effectively use insulin. The majority (90%) of diabetes patients have type 2 diabetes. (1) Based on the United Kingdom Prospective Diabetes Study (UKPDS), intensive blood glucose and blood pressure control significantly reduce the risk of microvascular and macrovascular complications in type 2 diabetics. While many studies have documented that patients often do not meet the glycemic control targets specified by national and international guidelines, factors associated with glycemic control are less well studied, one of which is the provider(s) of care.
Multidisciplinary approaches to care may be particularly important for diabetes management. According guidelines from the Canadian Diabetes Association (CDA), the diabetes health care team should be multi-and interdisciplinary. Presently in Ontario, the core diabetes health care team consists of at least a family physician and/or diabetes specialist, and diabetes educators (registered nurse and registered dietician).
Increasing the role played by allied health care professionals in diabetes care and their collaboration with physicians may represent a more cost-effective option for diabetes management. Several systematic reviews and meta-analyses have examined multidisciplinary care programs, but these have either been limited to a specific component of multidisciplinary care (e.g. intensified education programs), or were conducted as part of a broader disease management program, of which not all were multidisciplinary in nature. Most reviews also do not clearly define the intervention(s) of interest, making the evaluation of such multidisciplinary community programs challenging.
Evidence-Based Analysis Methods
Research Questions
What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a registered nurse, registered dietician and physician (primary care and/or specialist) for the management of type 2 diabetes compared to usual care? [Henceforth referred to as Model 1]
What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a pharmacist and a primary care physician for the management of type 2 diabetes compared to usual care? [Henceforth referred to as Model 2]
Inclusion Criteria
English language full-reports
Published between January 1, 2000 and September 28, 2008
Randomized controlled trials (RCTs), systematic reviews and meta-analyses
Type 2 diabetic adult population (≥18 years of age)
Total sample size ≥30
Describe specialized multidisciplinary community care defined as ambulatory-based care provided by at least two health care disciplines (of which at least one must be a specialist in diabetes) with integrated communication between the care providers.
Compared to usual care (defined as health care provision by non-specialist(s) in diabetes, such as primary care providers; may include referral to other health care professionals/services as necessary)
≥6 months follow-up
Exclusion Criteria
Studies where discrete results on diabetes cannot be abstracted
Predominantly home-based interventions
Inpatient-based interventions
Outcomes of Interest
The primary outcomes for this review were glycosylated hemoglobin (rHbA1c) levels and systolic blood pressure (SBP).
Search Strategy
A literature search was performed on September 28, 2008 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published between January 1, 2000 and September 28, 2008. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Given the high clinical heterogeneity of the articles that met the inclusion criteria, specific models of specialized multidisciplinary community care were examined based on models of care that are currently being supported in Ontario, models of care that were commonly reported in the literature, as well as suggestions from an Expert Advisory Panel Meeting held on January 21, 2009.
Summary of Findings
The initial search yielded 2,116 unique citations, from which 22 RCTs trials and nine systematic reviews published were identified as meeting the eligibility criteria. Of these, five studies focused on care provided by at least a nurse, dietician, and physician (primary care and/or specialist) model of care (Model 1; see Table ES 1), while three studies focused on care provided by at least a pharmacist and primary care physician (Model 2; see Table ES 2).
Based on moderate quality evidence, specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinically significant reduction in HbA1c of 1.0% compared with usual care. The effects of this model on SBP, however, are uncertain compared with usual care, based on very-low quality evidence. Specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinically significant reduction in both HbA1c of 1.05% (based on high quality evidence) and SBP of 7.13 mm Hg (based on moderate quality evidence) compared to usual care. For both models, the evidence does not suggest a preferred setting of care delivery (i.e., primary care vs. hospital outpatient clinic vs. community clinic).
Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 1
Mean change from baseline to follow-up between intervention and control groups
Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 2
Mean change from baseline to follow-up between intervention and control groups
PMCID: PMC3377524  PMID: 23074528
4.  Creating a “culture of research” in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program 
Clinical Trials (London, England)  2015;12(3):246-256.
The value of community-based cancer research has long been recognized. In addition to the National Cancer Institute’s Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period.
To facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials.
The health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important component yet often challenging to identify and collect. The model requires a strong emphasis on outreach that challenges hospitals to improve and expand their reach, particularly into underrepresented populations and catchment areas. These efforts build on trust and a referral pipeline within the community which take time and significant commitment to establish.
The National Cancer Institute Community Cancer Centers Program experience provides a relevant model to broadly address creating a culture of research in community hospitals that are increasingly networked via systems and consortiums. The strategies used align well with the National Cancer Institute—American Society of Clinical Oncology Accrual Symposium recommendations for patient-/community-, physician-/provider-, and site-/organizational-level approaches to clinical trials; they helped sites achieve organizational culture shifts that enhanced their cancer research programs. The National Cancer Institute Community Cancer Centers Program hospitals reported that the strategies were challenging to implement yet proved valuable as they provided useful metrics for programmatic assessment, planning, reporting, and growth. While focused on oncology trials, these concepts may be useful within other disease-focused research as well.
PMCID: PMC4420772  PMID: 25691600
Clinical trials; community; culture of research; community hospital research; National Cancer Institute Community Cancer Centers Program
5.  Establishing a Minority-Based Community Clinical Oncology Program: The University of Medicine and Dentistry of New Jersey, New Jersey Medical School–University Hospital Cancer Center Experience 
Journal of Oncology Practice  2012;9(2):e48-e54.
The authors present a guide to the necessary infrastructure and institutional support that must be in place before considering a program like the Minority-Based Community Clinical Oncology Program.
The Minority-Based Community Clinical Oncology Program (MB-CCOP) at University of Medicine and Dentistry of New Jersey, New Jersey Medical School–University Hospital Cancer Center was established to serve an unmet need in a medically, educationally, and socioeconomically underserved community of primarily African American and Latino patients in Newark and Essex County, New Jersey. The MB-CCOP was built on an existing infrastructure of multidisciplinary teams of cancer specialists who collaborated in patient care and an existing clinical research program, which included multilingual staff and a breast cancer navigator. This article highlights some of the unique opportunities and challenges involved in the startup of an MB-CCOP specifically relevant to an academic setting. We present a guide to the necessary infrastructure and institutional support that must be in place before considering such a program and some of the steps an institution can take to overcome barriers preventing successful enrollment of patients onto clinical trials.
PMCID: PMC3595450  PMID: 23814524
6.  A surveillance system for monitoring, public reporting, and improving minority access to cancer clinical trials 
The Institute of Medicine (IOM) has recommended that each person with cancer should have access to clinical trials, which have been associated with improving care quality and disparities. With no effective enrollment monitoring system, patterns of trial enrollment remain unclear.
We developed a population-based, statewide system designed to facilitate monitoring of cancer trial enrollment and targeting of future interventions to improve it.
Person-level cancer incidence data from the North Carolina Central Cancer Registry (NCCCR), person-level treatment trial accrual data from the National Cancer Institute (NCI), and county-level Area Resource Files (ARF) measures for 12 years, 1996–2007, were studied. De-identified person-level data necessitated county-level analysis. Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for each race, gender, year, and county combination. Multivariable analysis examined factors associated with trial accrual. Sensitivity analyses examined spurious fluctuations and temporal discordance of incidence and enrollment.
The NCI treatment trial enrollment rate was 2.39% for whites and 2.20% for minorities from 1996 to 2007, and 2.88% and 2.47%, respectively, for 2005–2007. Numerous counties had no minority enrollment. The 2005–2007 enrollment rates for white and minority females was 4.04% and 3.59%, respectively, and for white and minority males was 1.74% and 1.36%, respectively. Counties with a medical school or NCI Community Clinical Oncology Program (CCOP)-affiliated practice had higher trial enrollment.
We examined NCI trial accrual only – industry-sponsored and investigator-initiated trials were excluded; however, NCI studies comprise the majority of all clinical trial participants. Delays in data availability may hinder immediacy of population-based analyses.
Model stability and consistency suggest this system is effective for population-based enrollment surveillance. For North Carolina, it suggests a worsening disparity in minority trial enrollment, though our analyses elucidate targets for intervention. Regional enrollment variation suggests the importance of access to clinical research networks and infrastructure. Substantial gender differences merit further examination.
PMCID: PMC3539770  PMID: 22761398
cancer; surveillance; clinical trials enrollment; disparities
7.  Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial 
Trials  2014;15:299.
In the United States certain minority groups, such as racial/ethnic immigrant women, are less likely than non-Hispanic White women to be screened for cervical cancer. Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices. Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care. Another recent promising approach is using human papilloma virus (HPV) self-sampling. In this manuscript, we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women.
The South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS) is conducting a three-arm randomized trial among Hispanic, Haitian, and African American women in Miami-Dade County. Community health workers (CHW) based in each of three communities are recruiting 200 women at each site (600 total). Eligibility criteria include women aged 30–65 years who have not had a Pap smear test in the last 3 years. Prior to randomization, all women undergo a standardized structured interview. Women randomized to public health outreach, Group 1, receive culturally tailored educational materials. Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities. Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling. The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6 months after enrollment.
SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women. If successful, HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer.
Trial registration
Clinical # NCT02121548, registered April 21, 2014.
PMCID: PMC4127186  PMID: 25056208
Cervical cancer; Community-based participatory research; Haitian; Health disparities; Hispanic; Human papilloma virus; Immigrant; Minority; Screening
8.  Effect of a Community-Based Nursing Intervention on Mortality in Chronically Ill Older Adults: A Randomized Controlled Trial 
PLoS Medicine  2012;9(7):e1001265.
Kenneth Coburn and colleagues report findings from a randomized trial evaluating the effects of a complex nursing intervention on mortality risk among older individuals diagnosed with chronic health conditions.
Improving the health of chronically ill older adults is a major challenge facing modern health care systems. A community-based nursing intervention developed by Health Quality Partners (HQP) was one of 15 different models of care coordination tested in randomized controlled trials within the Medicare Coordinated Care Demonstration (MCCD), a national US study. Evaluation of the HQP program began in 2002. The study reported here was designed to evaluate the survival impact of the HQP program versus usual care up to five years post-enrollment.
Methods and Findings
HQP enrolled 1,736 adults aged 65 and over, with one or more eligible chronic conditions (coronary artery disease, heart failure, diabetes, asthma, hypertension, or hyperlipidemia) during the first six years of the study. The intervention group (n = 873) was offered a comprehensive, integrated, and tightly managed system of care coordination, disease management, and preventive services provided by community-based nurse care managers working collaboratively with primary care providers. The control group (n = 863) received usual care. Overall, a 25% lower relative risk of death (hazard ratio [HR] 0.75 [95% CI 0.57–1.00], p = 0.047) was observed among intervention participants with 86 (9.9%) deaths in the intervention group and 111 (12.9%) deaths in the control group during a mean follow-up of 4.2 years. When covariates for sex, age group, primary diagnosis, perceived health, number of medications taken, hospital stays in the past 6 months, and tobacco use were included, the adjusted HR was 0.73 (95% CI 0.55–0.98, p = 0.033). Subgroup analyses did not demonstrate statistically significant interaction effects for any subgroup. No suspected program-related adverse events were identified.
The HQP model of community-based nurse care management appeared to reduce all-cause mortality in chronically ill older adults. Limitations of the study are that few low-income and non-white individuals were enrolled and implementation was in a single geographic region of the US. Additional research to confirm these findings and determine the model's scalability and generalizability is warranted.
Trial Registration NCT01071967
Please see later in the article for the Editors' Summary
Editors' Summary
In almost every country in the world, the proportion of people aged over 60 years is growing faster than any other age group because of increased life expectancy. This demographic change has several implications for public health, especially as older age is a risk factor for many chronic diseases—diseases of long duration and generally slow progression. Chronic diseases, such as heart disease, stroke, cancer, chronic respiratory diseases, and diabetes, are by far the leading cause of death in the world, representing almost two-thirds of all deaths. Therefore in most countries, the challenge of managing increasingly ageing populations who have chronic illnesses demands an urgent response and countries such as the United States are actively researching possible solutions.
Why Was This Study Done?
Some studies suggest that innovations in chronic disease management that are led by nurses may help address the epidemic of chronic diseases by increasing the quality and reducing the cost of care. However, to date, reports of the evaluation of such interventions lack rigor and do not provide evidence of improved long-term health outcomes or reduced health care costs. So in this study, the researchers used the gold standard of research, a randomized controlled trial, to examine the impact of a community-based nurse care management model for older adults with chronic illnesses in the United States as part of a series of studies supported by the Centers for Medicare and Medicaid Services.
What Did the Researchers Do and Find?
The researchers recruited eligible patients aged 65 years and over with heart failure, coronary heart disease, asthma, diabetes, hypertension, and/or hyperlipidemia who received traditional Medicare—a fee for service insurance scheme in which beneficiaries can choose to receive their care from any Medicare provider—from participating primary care practices in Pennsylvania. The researchers then categorized patients according to their risk on the basis of several factors including the number of chronic diseases each individual had before randomizing patients to receive usual care or the nurse-led intervention. The intervention included an individualized plan comprising education, symptom monitoring, medication, counseling for adherence, help identifying, arranging, and monitoring community health and social service referrals in addition to group interventions such as weight loss maintenance and exercise classes. The researchers checked whether any participating patients had died by using the online Social Security Death Master File. Then the researchers used a statistical model to calculate the risk of death in both groups.
Of the 1,736 patients the researchers recruited into the trial, 873 were randomized to receive the intervention and 863 were in the control group (usual care). The researchers found that 86 (9.9%) participants in the intervention group and 111 (12.9%) participants in the control group died during the study period, representing a 25% lower relative risk of death among the intervention group. However, when the researchers considered other factors, such as sex, age group, primary diagnosis, perceived health, number of medications taken, hospital stays in the past 6 months, and tobacco use in their statistical model, this risk was slightly altered—0.73 risk of death in the intervention group.
What Do These Findings Mean?
These findings suggest that that community-based nurse care management is associated with a reduction in all-cause mortality among older adults with chronic illnesses who are beneficiaries of the fee for service Medicare scheme in the United States. These findings also support the important role of nurses in improving health outcomes in this group of patients and show the feasibility of implementing this program in collaboration with primary care practices. Future research is needed to test the adaptability, scalability, and generalizability of this model of care.
Additional Information
Please access these Web sites via the online version of this summary at
This study is further discussed in a PLoS Medicine Perspective by Arlene Bierman
Information about the Centers for Medicare and Medicaid Services is available
The World Health Organization provides statistics on the prevalence of both chronic illness and ageing
Heath Quality Partners provide information about the study
PMCID: PMC3398966  PMID: 22815653
9.  Eurocan plus report: feasibility study for coordination of national cancer research activities 
The EUROCAN+PLUS Project, called for by the European Parliament, was launched in October 2005 as a feasibility study for coordination of national cancer research activities in Europe. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people, the largest Europe–wide consultation ever conducted in the field of cancer research.
Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
It is essential to include the patients’ voice in the establishment of priority areas in cancer research at the present time. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community is evident. A top priority should be the development of translational research (in its widest form), leading to the development of effective and innovative cancer treatments and preventive strategies. Translational research ranges from bench–to–bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
The EUROCAN+PLUS Project recommends the creation of a small, permanent and independent European Cancer Initiative (ECI). This should be a model structure and was widely supported at both General Assemblies of the project. The ECI should assume responsibility for stimulating innovative cancer research and facilitating processes, becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ organizations, European institutions, Member States, industry and small and medium enterprises (SMEs), putting into practice solutions aimed at alleviating barriers to collaboration and coordination of cancer research activities in the European Union, and dealing with legal and regulatory issues. The development of an effective ECI will require time, but this entity should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co–operation between comprehensive cancer centres and basic research laboratories throughout Europe and (3) networking between funding bodies at the European level.
The European Parliament and its instruments have had a major influence in cancer control in Europe, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
Executive Summary
Cancer is one of the biggest public health crises facing Europe in the 21st century—one for which Europe is currently not prepared nor preparing itself. Cancer is a major cause of death in Europe with two million casualties and three million new cases diagnosed annually, and the situation is set to worsen as the population ages.
These facts led the European Parliament, through the Research Directorate-General of the European Commission, to call for initiatives for better coordination of cancer research efforts in the European Union. The EUROCAN+PLUS Project was launched in October 2005 as a feasibility study for coordination of national cancer research activities. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people. In this respect, the Project became the largest Europe-wide consultation ever conducted in the field of cancer research, implicating researchers, cancer centres and hospitals, administrators, healthcare professionals, funding agencies, industry, patients’ organizations and patients.
The Project first identified barriers impeding research and collaboration in research in Europe. Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain the formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
In addition, there is a shortage of leadership, a multiplicity of institutions each focusing on its own agenda, sub–optimal contact with industry, inadequate training, non–existent career paths, low personnel mobility in research especially among clinicians and inefficient funding—all conspiring against efficient collaboration in cancer care and research. European cancer research today does not have a functional translational research continuum, that is the process that exploits biomedical research innovations and converts them into prevention methods, diagnostic tools and therapies. Moreover, epidemiological research is not integrated with other types of cancer research, and the implementation of the European Directives on Clinical Trials 1 and on Personal Data Protection 2 has further slowed the innovation process in Europe. Furthermore, large inequalities in health and research exist between the EU–15 and the New Member States.
The picture is not entirely bleak, however, as the European cancer research scene presents several strengths, such as excellent basic research and clinical research and innovative etiological research that should be better exploited.
When considering recommendations, several priority dimensions had to be retained. It is essential that proposals include actions and recommendations that can benefit all Member States of the European Union and not just States with the elite centres. It is also essential to have a broader patient orientation to help provide the knowledge to establish cancer control possibilities when we exhaust what can be achieved by the implementation of current knowledge. It is vital that the actions proposed can contribute to the Lisbon Strategy to make Europe more innovative and competitive in (cancer) research.
The Project participants identified six areas for which consensus solutions should be implemented in order to obtain better coordination of cancer research activities. The required solutions are as follows. The proactive management of innovation, detection, facilitation of collaborations and maintenance of healthy competition within the European cancer research community.The establishment of an exchange portal of information for health professionals, patients and policy makers.The provision of guidance for translational and clinical research including the establishment of a translational research platform involving comprehensive cancer centres and cancer research centres.The coordination of calls and financial management of cancer research projects.The construction of a ‘one–stop shop’ as a contact interface between the industry, small and medium enterprises, scientists and other stakeholders.The support of greater involvement of healthcare professionals in translational research and multidisciplinary training.
In the course of the EUROCAN+PLUS consultative process, several key collaborative projects emerged between the various groups and institutes engaged in the consultation. There was a collaboration network established with Europe’s leading Comprehensive Cancer Centres; funding was awarded for a closer collaboration of Owners of Cancer Registries in Europe (EUROCOURSE); there was funding received from FP7 for an extensive network of leading Biological Resource Centres in Europe (BBMRI); a Working Group identified the special needs of Central, Eastern and South–eastern Europe and proposed a remedy (‘Warsaw Declaration’), and the concept of developing a one–stop shop for dealing with academia and industry including the Innovative Medicines Initiative (IMI) was discussed in detail.
Several other dimensions currently lacking were identified. There is an absolute necessity to include the patients’ voice in the establishment of priority areas in cancer research at the present time. It was a salutary lesson when it was recognized that all that is known about the quality of life of the cancer patient comes from the experience of a tiny proportion of cancer patients included in a few clinical trials. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community was evident. A top priority should be the development of translational research (in its widest form) and the development of effective and innovative cancer treatments and preventative strategies in the European Union. Translational research ranges from bench-to-bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
Having taken note of the barriers and the solutions and having examined relevant examples of existing European organizations in the field, it was agreed during the General Assembly of 19 November 2007 that the EUROCAN+PLUS Project had to recommend the creation of a small, permanent and neutral ECI. This should be a model structure and was widely supported at both General Assemblies of the project. The proposal is based on the successful model of the European Molecular Biology Organisation (EMBO), and its principal aims include providing a forum where researchers from all backgrounds and from all countries can meet with members of other specialities including patients, nurses, clinicians, funders and scientific administrators to develop priority programmes to make Europe more competitive in research and more focused on the cancer patient.
The ECI should assume responsibility for: stimulating innovative cancer research and facilitating processes;becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ and organizations;European institutions, Member States, industry and small and medium enterprises;putting into practice the aforementioned solutions aimed at alleviating barriers and coordinating cancer research activities in the EU;dealing with legal and regulatory issues.
Solutions implemented through the ECI will lead to better coordination and collaboration throughout Europe, more efficient use of resources, an increase in Europe’s attractiveness to the biomedical industry and better quality of cancer research and education of health professionals.
The Project considered that European legal instruments currently available were inadequate for addressing many aspects of the barriers identified and for the implementation of effective, lasting solutions. Therefore, the legal environment that could shelter an idea like the ECI remains to be defined but should be done so as a priority. In this context, the initiative of the European Commission for a new legal entity for research infrastructure might be a step in this direction. The development of an effective ECI will require time, but this should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass: (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co-operation between comprehensive cancer centres and basic research laboratories throughout Europe; (3) networking between funding bodies at the European level. Another topic deserving immediate attention is the creation of a European database on cancer research projects and cancer research facilities.
Despite enormous progress in cancer control in Europe during the past two decades, there was an increase of 300,000 in the number of new cases of cancer diagnosed between 2004 and 2006. The European Parliament and its instruments have had a major influence in cancer control, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
PMCID: PMC3234055  PMID: 22274749
10.  Improving Diversity in Cancer Research Trials: The Story of the Cancer Disparities Research Network 
The participation of racial and ethnic minorities and underserved populations in clinical trials is a critical link between scientific innovation and improvements in health care delivery and health outcomes. However, these population groups continue to be underrepresented in research. We describe the development of the Cancer Disparities Research Network (CDRN) to improve minority and underserved populations’ participation in biobanking research. Between February – October 2011, we conducted a regional assessment to identify challenges and opportunities for cancer trials and biobanking research across the CDRN. Representatives from ten CDRN biorepository facilities completed an online survey assessing their facilities’ minority biospecimen collection, biobanking practices, and education/outreach initiatives. Representatives of eight facilities also participated in stakeholder interviews. The majority (70%) of facilities reported that specimens were available for research, although only one-tenth of these specimens were from non-White patients. Most facilities collected a patient’s age, gender, race, medical history, and ethnicity with samples; however, less than half also collected family health history, education level, household income, or primary language spoken. In addition, few institutions collected Asian or Hispanic subgroup information. Only a few reported biospecimen collection outreach programs specifically targeting minority and underserved populations. Biospecimen directors and administrators indicated that funding, biospecimen sharing procedures, and standardization barriers limited their facilities from collaborating in biospecimen collection programs, despite their great interest. These findings suggest that the CDRN can provide opportunities for collaboration, resource sharing, and the fostering of research ideas to address cancer disparities in biospecimen research.
PMCID: PMC4029870  PMID: 24519744
Biobanking; clinical trials; cancer research; minority and underrepresented populations
11.  Task Shifting for Scale-up of HIV Care: Evaluation of Nurse-Centered Antiretroviral Treatment at Rural Health Centers in Rwanda 
PLoS Medicine  2009;6(10):e1000163.
Fabienne Shumbusho and colleagues evaluate a task-shifting model of nurse-centered antiretroviral treatment prescribing in rural primary health centers in Rwanda and find that nurses can effectively and safely prescribe ART when given adequate training, mentoring, and support.
The shortage of human resources for health, and in particular physicians, is one of the major barriers to achieve universal access to HIV care and treatment. In September 2005, a pilot program of nurse-centered antiretroviral treatment (ART) prescription was launched in three rural primary health centers in Rwanda. We retrospectively evaluated the feasibility and effectiveness of this task-shifting model using descriptive data.
Methods and Findings
Medical records of 1,076 patients enrolled in HIV care and treatment services from September 2005 to March 2008 were reviewed to assess: (i) compliance with national guidelines for ART eligibility and prescription, and patient monitoring and (ii) key outcomes, such as retention, body weight, and CD4 cell count change at 6, 12, 18, and 24 mo after ART initiation. Of these, no ineligible patients were started on ART and only one patient received an inappropriate ART prescription. Of the 435 patients who initiated ART, the vast majority had adherence and side effects assessed at each clinic visit (89% and 84%, respectively). By March 2008, 390 (90%) patients were alive on ART, 29 (7%) had died, one (<1%) was lost to follow-up, and none had stopped treatment. Patient retention was about 92% by 12 mo and 91% by 24 mo. Depending on initial stage of disease, mean CD4 cell count increased between 97 and 128 cells/µl in the first 6 mo after treatment initiation and between 79 and 129 cells/µl from 6 to 24 mo of treatment. Mean weight increased significantly in the first 6 mo, between 1.8 and 4.3 kg, with no significant increases from 6 to 24 mo.
Patient outcomes in our pilot program compared favorably with other ART cohorts in sub-Saharan Africa and with those from a recent evaluation of the national ART program in Rwanda. These findings suggest that nurses can effectively and safely prescribe ART when given adequate training, mentoring, and support.
Please see later in the article for the Editors' Summary
Editors' Summary
Infection with the human immunodeficiency virus (HIV) is a serious health problem in sub-Saharan Africa. The virus attacks white blood cells that protect against infection, most commonly a type of white blood cell called CD4. When a person has been infected with HIV for a long time, the number of CD4 cells they have goes down, resulting in acquired immune deficiency syndrome (AIDS), in which the person's immune system no longer functions effectively.
The World Health Organization (WHO) has divided the disease into four stages as it progresses, according to symptoms including weight loss and so-called opportunistic infections. These are known as clinical stage I, II, III, or IV but were revised and renamed 1, 2, 3, and 4 in September 2005. HIV infection and AIDS cannot be cured but they can be managed with antiretroviral treatment (ART). The WHO currently recommends that ART is begun when the CD4 count falls below 350.
Rwanda is a country situated in the central Africa with a population of around 9 million inhabitants; over 3% of the rural population and 7% of the urban population are infected with HIV. In 2007, the WHO estimated that 220,000 Rwandan children had lost one or both parents to AIDS.
Why Was This Study Done?
The WHO estimates that 9.7 million people with HIV in low- to middle-income countries need ART but at the end of 2007, only 30% of these, including in Rwanda, had access to treatment. In many low-income countries a major factor in this is a lack of doctors. Rwanda, for example, has one doctor per 50,000 inhabitants and one nurse per 3,900 inhabitants.
This situation has led the WHO to recommend “task shifting,” i.e., that the task of prescribing ART should be shifted from doctors to nurses so that more patients can be treated. This type of reorganization is well studied in high-income countries, but the researchers wanted to help develop a system for treating AIDS that would be effective and timely in a predominantly rural, low-income setting such as Rwanda.
What Did the Researchers Do and Find?
In conjunction with the Rwandan Ministry of Health, the researchers developed and piloted a task-shifting program, in which one nurse in each of three rural Rwandan primary health centers (PHCs) was trained to examine HIV patients and prescribe ART in simple cases. Nurses had to complete more than 50 consultations observed by the doctor before being permitted to consult patients independently. More complex cases were referred to a doctor. The authors developed standard checklists, instructions, and evaluation forms to guide nurses and the doctors who supervised them once a week.
The authors evaluated the pilot program by reviewing the records of 1,076 patients who enrolled on it between September 2005 and March 2008. They looked to see whether the nurses had followed guidelines and monitored the patients correctly. They also considered health outcomes for the patients, such as their death rate, their body weight, their CD4 cell count, and whether they maintained contact with caregivers.
They found that by March 2008, 451 patients had been eligible for ART. 435 received treatment and none of the patients were prescribed ART when they should not have been. Only one prescription did not follow national guidelines.
At every visit, nurses were supposed to assess whether patients were taking their drugs and to monitor side effects. They did this and maintained records correctly for the vast majority of the 435 patients who were prescribed ART. 390 patients (over 90%) of the 435 prescribed receiving ART continued to take it and maintain contact with the pilot PHC's program. 29 patients died. Only one was lost to follow up and the others transferred to another ART site. The majority gained weight in the first six months and their CD4 cell counts rose. Outcomes, including death rate, were similar to those treated on the (doctor-led) Rwandan national ART program and other sub-Saharan African national (doctor-led) programs.
What Do These Findings Mean?
The study suggests that nurses are able to prescribe ART safely and effectively in a rural sub-Saharan setting, given sufficient training, mentoring, and support. Nurse-led prescribing of ART could mean that timely, appropriate treatment reaches many more HIV patients. It would reduce the burden of HIV care for doctors, freeing their time for other duties, and the study is already being used by the Rwandan Ministry of Health as a basis for plans to adopt a task-shifting strategy for the national ART program.
The study does have some limitations. The pilot program was funded and designed as a health project to deliver ART in rural areas, rather than a research project to compare nurse-led and doctor-led ART programs. There was no group of equivalent patients treated by doctors rather than nurses for direct comparison, although the authors did compare outcomes with those achieved nationally for doctor-led ART. The most promising sites, nurses, and patients were selected for the pilot and careful monitoring may have been an additional motivation for the nurses and doctors taking part. Health professionals in a scaled-up program may not be as committed as those in the pilot, who were carefully monitored. In addition, the nature of the pilot, which lasted for under three years and recruited new patients throughout, meant that patients were followed up for relatively short periods.
The authors also warn that they did not consider in this study the changes task shifting will make to doctors' roles and the skills required of both doctors and nurses. They recommend that task shifting should be implemented as part of a wider investment in health systems, human resources, training, adapted medical records, tools, and protocols.
Additional Information
Please access these Web sites via the online version of this summary at
PLoS Medicine includes a page collecting together its recent articles on HIV infection and AIDS that includes research articles, perspectives, editorials, and policy forums provides news, views, and information about science, technology, and the developing world, including a section specific to HIV/AIDs
The World Health Organization (WHO) has published a downloadable booklet Task Shifting to Tackle Health Worker Shortages
The WHO offers information on HIV and AIDS (in Arabic, Chinese, English, French, Russian, and Spanish) as well as health information and fact sheets on individual countries, including on Rwanda
The UNAIDS/WHO working group on HIV/AIDS and Sexually Transmitted Infections (STI) Surveillance gathers and publishes data on the prevalence of HIV and AIDS in individual countries, including on Rwanda
AIDS.ORG provides information to help prevent HIV infections and to improve the lives of those affected by HIV and AIDS. Factsheets on many aspects of HIV and AIDS are available. It is the official online publisher of AIDS Treatment News
PMCID: PMC2752160  PMID: 19823569
12.  Implementing Cancer Prevention into Clinical Practice 
Cancer prevention has been associated with decreased rates of cancer incidence and increased survival. Cancer prevention, however, can have a greater impact if barriers to implementing cancer prevention into practice are removed and opportunities are both fostered and seized. The purpose of this article is to identify barriers and opportunities to cancer prevention in clinical practice and provide recommendations for the future. A multidisciplinary team participated in “The Future Directions Cancer Prevention and Control: Workforce Implications for Training, Practice and Policy” workshop on October 17-18, 2009 at The University of Texas MD Anderson Cancer Center in Houston, TX. During the meeting, the team discussed barriers and opportunities for the implementation of cancer prevention into clinical practice. Further data were collected from peer-reviewed journals and published government and cancer agencies reports. Several issues were identified: 1) The funding allocated to basic cancer prevention research and application is not optimal and less than that for cancer treatment; 2) Participation in cancer prevention behaviors and screening practices are lower than desired, especially among the uninsured; 3) A shortage in healthcare professionals is a major challenge in meeting the future needs of cancer prevention; 4) Demands on medical schools to balance increased enrollment, incorporate cancer prevention in an already crowded curriculum, and develop faculty are daunting; and 5) Healthcare reforms in 2010 provide both opportunities and additional challenges for cancer prevention. Based on the current state of cancer prevention, we formed six recommendations: 1) Additional funding for cancer prevention research with a focus on implementation into practice; 2) Improved tracking of cancer prevention research funding and the outcomes associated with it; 3) Continued monitoring of cancer prevention services participation with emphasis on closing the gap in health disparities; 4) Financial and technical assistance to healthcare professional schools for incorporating cancer prevention into curricula; 5) Assessment of the current state of technology in cancer prevention care; and 6) The use of effective multidisciplinary teams in cancer prevention care. Improved delivery of cancer prevention services can have a tremendous impact on cancer incidence and survival rates.
PMCID: PMC4126604  PMID: 22367592
Prevention; Control; Workforce; Cancer
13.  Feasibility of Conducting a Randomized Controlled Trial of Telemental Health with Children Diagnosed with Attention-Deficit/Hyperactivity Disorder in Underserved Communities 
Telemental health (TMH), the use of videoteleconferencing to provide care that is usually delivered in person, is increasingly used to rectify disparities in access to care. Few studies, however, have been conducted to demonstrate the effectiveness of TMH as a service delivery model. The Children's Attention-Deficit/Hyperactivity Disorder (ADHD) Telemental Health Treatment Study (CATTS) is a randomized clinical trial (RCT) of TMH conducted in multiple underserved communities. This article reports on the feasibility of conducting an effectiveness trial of TMH with children.
The CATTS trial used videoteleconferencing to provide guideline-based care and secure web sites to coordinate key aspects of trial implementation, such as participant recruitment and retention, intervention fidelity, and completion of assessments.
The CATTS trial engaged seven communities and 150 primary care providers as partners in the study, and enrolled 223 children 5.5–12.9 years old. The intervention group completed an average of 5.3 of 6.0 planned sessions and 96% of controls completed a TMH consultation. Both groups completed an average of 4.8 of the 5.0 assessments. Clinicians demonstrated high fidelity to their treatment protocols. Minor technical difficulties did not interfere with providing care.
The CATTS trial demonstrated the feasibility of conducting an RCT of TMH with children living in multiple underserved communities. Telecommunications technologies can facilitate the coordination of research activities across sites and clinicians. Future trials should work closely with study partners to ensure referral of a representative study sample. Further trials are needed to help establish the effectiveness of TMH as a service delivery model.
Trial Registration
PMCID: PMC3749708  PMID: 23952183
14.  Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review 
PLoS Medicine  2010;7(11):e1000368.
Patrina Caldwell and colleagues performed a systematic review of randomized studies that compared methods of recruiting individual study participants into trials, and found that strategies that focus on increasing potential participants' awareness of the specific health problem, and that engaged them, appeared to increase recruitment.
Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs.
Methods and Findings
A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00–2.18], attendance at an education session [RR 1.14, 95% CI 1.01–1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14–1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11–2.74), and also monetary incentives (RR1.39, 95% CI 1.13–1.64 to RR 1.53, 95% CI 1.28–1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007.
Recruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis.
Please see later in the article for the Editors' Summary
Editors' Summary
Before any health care intervention—a treatment for a disease or a measure such as vaccination that is designed to prevent an illness—is adopted by the medical community, it undergoes exhaustive laboratory-based and clinical research. In the laboratory, scientists investigate the causes of diseases, identify potential new treatments or preventive methods, and test these interventions in animals. New interventions that look hopeful are then investigated in clinical trials—studies that test these interventions in people by following a strict trial protocol or action plan. Phase I trials test interventions in a few healthy volunteers or patients to evaluate their safety and to identify possible side effects. In phase II trials, a larger group of patients receives an intervention to evaluate its safety further and to get an initial idea of its effectiveness. In phase III trials, very large groups of patients (sometimes in excess of a thousand people) are randomly assigned to receive the new intervention or an established intervention or placebo (dummy intervention). These “randomized controlled trials” or “RCTs” provide the most reliable information about the effectiveness and safety of health care interventions.
Why Was This Study Done?
Patients who participate in clinical trials must fulfill the inclusion criteria laid down in the trial protocol and must be given information about the trial, its risks, and potential benefits before agreeing to participate (informed consent). Unfortunately, many RCTs struggle to enroll the number of patients specified in their trial protocol, which can reduce a trial's ability to measure the effect of a new intervention. Inadequate recruitment can also increase costs and, in the worst cases, prevent trial completion. Several strategies have been developed to improve recruitment but it is not clear which strategy works best. In this study, the researchers undertake a systematic review (a study that uses predefined criteria to identify all the research on a given topic) of “recruitment trials”—studies that have randomly divided potential RCT participants into groups, applied different strategies for recruitment to each group, and compared recruitment rates in the groups.
What Did the Researchers Do and Find?
The researchers identified 37 randomized trials of recruitment strategies into real and mock RCTs (where no actual trial occurred). In all, 18,812 people agreed to participate in an RCT in these recruitment trials out of at least 59,354 people approached. Some of these trials investigated novel strategies for recruitment, such as changes in how patients are randomized. Others looked at the effect of recruiter differences (for example, increased contact between the health care professionals doing the recruiting and the trial investigators), the effect of offering monetary incentives to participants, and the effect of giving more information about the trial to potential participants. Recruitment strategies that improved people's awareness of the health problem being studied—provision of an interactive computer program or a video about the health condition, attendance at an educational session, or inclusion of a health questionnaire in the recruitment process—improved recruitment rates, as did monetary incentives. Increasing patients' understanding about the trial process itself, recruiter differences, and alterations in consent design and randomization generally had no effect on recruitment rates although consent rates were higher when patients knew the treatment to which they had been randomly allocated before consenting. However, differential losses among the patients in different treatment groups in such nonblinded trials may jeopardize study findings.
What Do These Findings Mean?
These findings suggest that trial recruitment strategies that focus on increasing the awareness of potential participants of the health problem being studied and its possible effects on their health, and that engage potential participants in the trial process are likely to increase recruitment to RCTs. The accuracy of these findings depends on whether the researchers identified all the published research on recruitment strategies and on whether other research on recruitment strategies has been undertaken and not published that could alter these findings. Furthermore, because about half of the recruitment trials identified by the researchers were undertaken in the US, the successful strategies identified here might not be generalizable to other countries. Nevertheless, these recruitment strategies should now be investigated further to ensure that the future evaluation of new health care interventions is not hampered by poor recruitment into RCTs.
Additional Information
Please access these Web sites via the online version of this summary at
The Web site is a searchable register of federally and privately supported clinical trials in the US and around the world, providing information about all aspects of clinical trials
The US National Institutes of Health provides information about clinical trials
The UK National Health Service Choices Web site has information for patients about clinical trials and medical research
The UK Medical Research Council Clinical Trials Units also provides information for patients about clinical trials and links to information on clinical trials provided by other organizations
MedlinePlus has links to further resources on clinical trials (in English and Spanish)
The Australian Government's National Health and Medical Research Council has information about clinical trials
WHO International Clinical Trials Registry Platform aims to ensure that all trials are publicly accessible to those making health care decisions
The Star Child Health International Forum of Standards for Research is a resource center for pediatric clinical trial design, conduct, and reporting
PMCID: PMC2976724  PMID: 21085696
15.  Solar Drinking Water Disinfection (SODIS) to Reduce Childhood Diarrhoea in Rural Bolivia: A Cluster-Randomized, Controlled Trial 
PLoS Medicine  2009;6(8):e1000125.
Daniel Maeusezahl and colleagues conducted a cluster-randomized controlled trial in rural Bolivia of solar drinking water disinfection, and find only moderate compliance with the intervention and no evidence of reduction in diarrhea among children.
Solar drinking water disinfection (SODIS) is a low-cost, point-of-use water purification method that has been disseminated globally. Laboratory studies suggest that SODIS is highly efficacious in inactivating waterborne pathogens. Previous field studies provided limited evidence for its effectiveness in reducing diarrhoea.
Methods and Findings
We conducted a cluster-randomized controlled trial in 22 rural communities in Bolivia to evaluate the effect of SODIS in reducing diarrhoea among children under the age of 5 y. A local nongovernmental organisation conducted a standardised interactive SODIS-promotion campaign in 11 communities targeting households, communities, and primary schools. Mothers completed a daily child health diary for 1 y. Within the intervention arm 225 households (376 children) were trained to expose water-filled polyethyleneteraphtalate bottles to sunlight. Eleven communities (200 households, 349 children) served as a control. We recorded 166,971 person-days of observation during the trial representing 79.9% and 78.9% of the total possible person-days of child observation in intervention and control arms, respectively. Mean compliance with SODIS was 32.1%. The reported incidence rate of gastrointestinal illness in children in the intervention arm was 3.6 compared to 4.3 episodes/year at risk in the control arm. The relative rate of diarrhoea adjusted for intracluster correlation was 0.81 (95% confidence interval 0.59–1.12). The median length of diarrhoea was 3 d in both groups.
Despite an extensive SODIS promotion campaign we found only moderate compliance with the intervention and no strong evidence for a substantive reduction in diarrhoea among children. These results suggest that there is a need for better evidence of how the well-established laboratory efficacy of this home-based water treatment method translates into field effectiveness under various cultural settings and intervention intensities. Further global promotion of SODIS for general use should be undertaken with care until such evidence is available.
Trial Registration NCT00731497
Please see later in the article for Editors' Summary
Editors' Summary
Thirsty? Well, turn on the tap and have a drink of refreshing, clean, safe water. Unfortunately, more than one billion people around the world don't have this option. Instead of the endless supply of safe drinking water that people living in affluent, developed countries take for granted, more than a third of people living in developing countries only have contaminated water from rivers, lakes, or wells to drink. Because of limited access to safe drinking water, poor sanitation, and poor personal hygiene, 1.8 million people (mainly children under 5 years old) die every year from diarrheal diseases. This death toll could be greatly reduced by lowering the numbers of disease-causing microbes in household drinking water. One promising simple, low-cost, point-of-use water purification method is solar drinking water disinfection (SODIS). In SODIS, recycled transparent plastic drinks bottles containing contaminated water are exposed to full sunlight for 6 hours. During this exposure, ultraviolet radiation from the sun, together with an increase in temperature, inactivates the disease-causing organisms in the water.
Why Was This Study Done?
SODIS has been promoted as an effective method to purify household water since 1999, and about 2 million people now use the approach ( However, although SODIS works well under laboratory conditions, very few studies have investigated its ability to reduce the number of cases of diarrhea occurring in a population over a specific time period (the incidence of diarrhea) in the real world. Before any more resources are used to promote SODIS—its effective implementation requires intensive and on-going education—it is important to be sure that SODIS really does reduce the burden of diarrhea in communities in the developing world. In this study, therefore, the researchers undertake a cluster-randomized controlled trial (a study in which groups of people are randomly assigned to receive an intervention or to act as controls) in 22 rural communities in Bolivia to evaluate the ability of SODIS to reduce diarrhea in children under 5 years old.
What Did the Researchers Do and Find?
For their trial, the researchers enrolled 22 rural Bolivian communities that included at least 30 children under 5 years old and that relied on drinking water resources that were contaminated with disease-causing organisms. They randomly assigned 11 communities (225 households, 376 children) to receive the intervention—a standardized, interactive SODIS promotion campaign conducted by Project Concern International (a nongovernmental organization)—and 11 communities (200 households, 349 children) to act as controls. Households in the intervention arm were trained to expose water-filled plastic bottles for at least 6 hours to sunlight using demonstrations, role play, and videos. Mothers in both arms of the trial completed a daily child health diary for a year. Almost 80% of the households self-reported using SODIS at the beginning and end of the study. However, community-based field workers estimated that only 32.1% of households on average used SODIS. Data collected in the child health diaries, which were completed on more than three-quarters of days in both arms of the trial, indicated that the children in the intervention arm had 3.6 episodes of diarrhea per year whereas the children in the control arm had 4.3 episodes of diarrhea per year. The difference in episode numbers was not statistically significant, however. That is, the small difference in the incidence of diarrhea between the arms of the trial may have occurred by chance and may not be related to the intervention.
What Do These Findings Mean?
These findings indicate that, despite an intensive campaign to promote SODIS, less than a third of households in the trial routinely treated their water in the recommended manner. Moreover, these findings fail to provide strong evidence of a marked reduction of the incidence of diarrhea among children following implementation of SODIS although some aspects of the study design may have resulted in the efficacy of SODIS being underestimated. Thus, until additional studies of the effectiveness of SODIS in various real world settings have been completed, it may be unwise to extend the global promotion of SODIS for general use any further.
Additional Information
Please access these Web sites via the online version of this summary at
The PLoS Medicine editors wrote an editorial arguing that water should be a human right
The World Health Organization provides information about household water treatment and safe storage and about the importance of water, sanitation, and hygiene for health (in several languages)
The SODIS Reference Center provides detailed information about solar water disinfection (in several languages)
The SODIS Foundation in Bolivia provides practical information for the roll-out of solar water disinfection in Latin America (in Spanish and English)
Project Concern International provides information about its campaign to promote SODIS in Bolivia (in Spanish)
The Water Supply and Sanitation Collaborative Council (WSSCC) is a global multi-stakeholder partnership organization with a goal of advocating to achieve sustainable water supply and sanitation for all people
PMCID: PMC2719054  PMID: 19688036
16.  The Effectiveness of Mobile-Health Technologies to Improve Health Care Service Delivery Processes: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(1):e1001363.
Caroline Free and colleagues systematically review controlled trials of mobile technology interventions to improve health care delivery processes and show that current interventions give only modest benefits and that high-quality trials measuring clinical outcomes are needed.
Mobile health interventions could have beneficial effects on health care delivery processes. We aimed to conduct a systematic review of controlled trials of mobile technology interventions to improve health care delivery processes.
Methods and Findings
We searched for all controlled trials of mobile technology based health interventions using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990–Sept 2010). Two authors independently extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and we used random effects meta-analysis to give pooled estimates.
We identified 42 trials. None of the trials had low risk of bias. Seven trials of health care provider support reported 25 outcomes regarding appropriate disease management, of which 11 showed statistically significant benefits. One trial reported a statistically significant improvement in nurse/surgeon communication using mobile phones. Two trials reported statistically significant reductions in correct diagnoses using mobile technology photos compared to gold standard. The pooled effect on appointment attendance using text message (short message service or SMS) reminders versus no reminder was increased, with a relative risk (RR) of 1.06 (95% CI 1.05–1.07, I2 = 6%). The pooled effects on the number of cancelled appointments was not significantly increased RR 1.08 (95% CI 0.89–1.30). There was no difference in attendance using SMS reminders versus other reminders (RR 0.98, 95% CI 0.94–1.02, respectively). To address the limitation of the older search, we also reviewed more recent literature.
The results for health care provider support interventions on diagnosis and management outcomes are generally consistent with modest benefits. Trials using mobile technology-based photos reported reductions in correct diagnoses when compared to the gold standard. SMS appointment reminders have modest benefits and may be appropriate for implementation. High quality trials measuring clinical outcomes are needed.
Please see later in the article for the Editors' Summary
Editors’ Summary
Over the past few decades, computing and communication technologies have changed dramatically. Bulky, slow computers have been replaced by portable devices that can complete increasingly complex tasks in less and less time. Similarly, landlines have been replaced by mobile phones and other mobile communication technologies that can connect people anytime and anywhere, and that can transmit text messages (short message service; SMS), photographs, and data at the touch of a button. These advances have led to the development of mobile-health (mHealth)—the use of mobile computing and communication technologies in health care and public health. mHealth has many applications. It can be used to facilitate data collection and to encourage health-care consumers to adopt healthy lifestyles or to self-manage chronic conditions. It can also be used to improve health-care service delivery processes by targeting health-care providers or communication between these providers and their patients. So, for example, mobile technologies can be used to provide clinical management support in settings where there are no specialist clinicians, and they can be used to send patients test results and timely reminders of appointments.
Why Was This Study Done?
Many experts believe that mHealth interventions could greatly improve health-care delivery processes, particularly in resource-poor settings. The results of several controlled trials (studies that compare the outcomes of people who do or do not receive an intervention) of mHealth interventions designed to improve health-care delivery processes have been published. However, these data have not been comprehensively reviewed, and the effectiveness of this type of mHealth intervention has not been quantified. Here, the researchers rectify this situation by undertaking a systematic review and meta-analysis of controlled trials of mobile technology-based interventions designed to improve health-care service delivery processes. A systematic review is a study that uses predefined criteria to identify all the research on a given topic; a meta-analysis is a statistical approach that is used to pool the results of several independent studies.
What Did the Researchers Do and Find?
The researchers identified 42 controlled trials that investigated mobile technology-based interventions designed to improve health-care service delivery processes. None of the trials were of high quality—many had methodological problems likely to affect the accuracy of their findings—and nearly all were undertaken in high-income countries. Thirty-two of the trials tested interventions directed at health-care providers. Of these trials, seven investigated interventions providing health-care provider education, 18 investigated interventions supporting clinical diagnosis and treatment, and seven investigated interventions to facilitate communication between health-care providers. Several of the trials reported that the tested intervention led to statistically significant improvements (improvements unlikely to have happened by chance) in outcomes related to disease management. However, two trials that used mobile phones to transmit photos to off-site clinicians for diagnosis reported significant reductions in correct diagnoses compared to diagnosis by an on-site specialist. Ten of the 42 trials investigated interventions targeting communication between health-care providers and patients. Eight of these trials investigated SMS-based appointment reminders. Meta-analyses of the results of these trials indicated that using SMS appointment reminders significantly but modestly increased patient attendance compared to no reminders. However, SMS reminders were no more effective than postal or phone call reminders, and texting reminders to patients who persistently missed appointments did not significantly change the number of cancelled appointments.
What Do These Findings Mean?
These findings indicate that some mHealth interventions designed to improve health-care service delivery processes are modestly effective, but they also highlight the need for more trials of these interventions. Specifically, these findings show that although some interventions designed to provide support for health-care providers modestly improved some aspects of clinical diagnosis and management, other interventions had deleterious effects—most notably, the use of mobile technology–based photos for diagnosis. In terms of mHealth interventions targeting communication between health-care providers and patients, the finding that SMS appointment reminders have modest benefits suggests that implementation of this intervention should be considered, at least in high-income settings. However, the researchers stress that more trials are needed to robustly establish the ability of mobile technology-based interventions to improve health-care delivery processes. These trials need to be of high quality, they should be undertaken in resource-limited settings as well as in high-income countries, and, ideally, they should consider interventions that combine mHealth and conventional approaches.
Additional Information
Please access these Web sites via the online version of this summary at
A related PLOS Medicine Research Article by Free et al. investigates the effectiveness of mHealth technology-based health behavior change and disease management interventions for health-care consumers
Wikipedia has a page on mHealth (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
mHealth: New horizons for health through mobile technologies is a global survey of mHealth prepared by the World Health Organization’s Global Observatory for eHealth (eHealth is health-care practice supported by electronic processes and communication)
The mHealth in Low-Resource Settings website, which is maintained by the Netherlands Royal Tropical Institute, provides information on the current use, potential, and limitations of mHealth in low-resource settings
The US National Institutes of Health Fogarty International Center provides links to resources and information about mHealth
PMCID: PMC3566926  PMID: 23458994
17.  Keeping Pace With Oral Chemotherapy 
Although the rising number of oral chemotherapy agents offers many patients with cancer a more convenient and less invasive treatment option compared with infusion therapy, multiple risks and challenges have been identified with the oral regimen, including dosing errors, drug interactions, and nonadherence or overadherence. Until recently, cancer care providers had maintained a considerable amount of control, including the certainty that the right drug was being administered in the right dose, via the right route, at the right time, and to the right patient—all of which were meticulously documented in patient records. In contrast, oral chemotherapy takes much of the control out of the clinician's hands and places tremendous responsibility on the patient, raising a number of adherence and control issues. Studies regarding oral hormonal therapy for breast cancer have described adherence rates ramping down from 83% to 77% within the first 2 years of therapy. These figures continue to decrease over time to a range of 50% to 64% within 4 to 5 years. On the basis of these data and a literature review, we developed a program to promote adherence to oral anticancer protocols.
Our team took a proactive, team-focused approach and established protocols at a time when oral chemotherapies were still at a low volume. In addition to infrastructures, policies, and procedures promoting collaborative communications among physicians, nurses, and pharmacists, we developed an in-depth educational component that provides the linchpin for ensuring an effective oral chemotherapy program. Our program focuses on three key pillars: education, communication, and follow-up. Our project team first conducted an inclusive review of available literature, with the objective of designing processes that would help our program directly address existing risks and challenges. Then we introduced concepts for the formalized program to our cancer center physicians, whose support was paramount to successful implementation. The next step was to start the program with a mandatory in-service for all clinical staff, which included a presentation of the research evidence that prompted the creation of this model for oral chemotherapy. To enhance patient understanding, our team provides printed materials, individualized calendars, and in some cases preloaded pillboxes to assist patients. Concurrently, our nurses provide weekly telephone intervention for the second and third months and monthly phone interventions thereafter. Communication is key to the success of the program. This includes the use of a translation service to ensure effective communication with all non–English-speaking patients. We intervene early for those patients with financial barriers and offer a variety of referrals and resources for emotional, nutritional, and patient support services, including transportation issues.
Since the inception of the program, the in-service has been incorporated into our new employee orientation. At the same time, a growing number of cancer center physicians are embracing the program. The program has received the attention of the Oncology Roundtable, which developed a Webinar around the topic, and been described in a feature article in an oncology journal. Finally, our team has been tapped to educate other pharmacists regarding oral agents, toxicity profiles, and safe handling.
By combining safeguards, patient education strategies, intensive follow-up, and a system of effective checks and balances, our center is taking significant steps to maximize patient safety and oral chemotherapy treatment effectiveness, while keeping pace with the rapidly occurring changes in oncology practice.
PMCID: PMC3457830
18.  Recruitment and Retention Results for a Population-based Cervical Cancer Biobehavioral Clinical Trial 
Gynecologic oncology  2011;121(3):558-564.
Minority and low-income cancer patients are underrepresented in clinical trials, contributing to diminished access to state-of-the-art care and disparities in cancer outcomes including survivorship issues. In cervical cancer, there is a disproportionate disease burden among minority and underserved women and persistent quality of life disruption. We encountered significant challenges in both recruitment and retention in a randomized biobehavioral clinical trial for cervical cancer survivors, identified through California Cancer Registries, leading to this investigation.
To determine differential rates of accrual and retention, data from our trial are analyzed using descriptive statistics, logistic regression and multivariate analysis of variance. Ethnic differences in associations between covariables and attrition rates were tested by interaction factors. Process evaluation and focus group data were obtained to inform improvement strategies.
Of eligible subjects with viable phone numbers, 29% enrolled and 71% actively or passively refused. Enrolled Hispanic women were more likely to have less education (p<0.001), lower income (p=0.003), and more children (p=0.028). The drop out rate was associated with less education (p=0.012), foreign-birth (p=0.061), speaking Spanish in the home (p=0.012). Reported reasons for active refusal were ‘too busy’ for all women, ‘too emotional’ for non-Hispanic women, ‘too ill’ and phlebotomy for Hispanic women. Subsequent focus groups identified specific strategies to improve study materials.
Although population-based recruitment of minority and underserved cancer patients continues to be a challenge, specific sociodemographic and disease variables can predict accrual difficulties. The information herein, taken together with disease and culturally relevant strategies, can be useful when recruiting underserved cancer survivors.
PMCID: PMC4572839  PMID: 21402400
Cervical Cancer; Recruitment; Retention; Randomized Clinical Trial; Quality of Life; Psychosocial; Telephone Counseling
19.  Perceptions of cancer clinical research among African American men in North Carolina 
The problem of cancer health disparities is substantial. Clinical trials are widely advocated as a means of reducing disparities and bringing state-of-the-art care to the broader community, where most cancer care is delivered. This study sought to develop a better understanding of why disproportionately few African American men enroll in clinical trials given their substantial cancer burden.
This study applied community-based participatory research (CBPR) methods to design and conduct four focus groups of African American male cancer survivors and their caregivers in North Carolina.
Among major themes, participants expressed confusion about the relationship between clinical trials, treatment, and research, signifying patient confusion and misinterpretation of common clinical trial terminology. Social norms including gender barriers and generational differences remain problematic; participants often reported that men do not talk about health issues, are unwilling to go to the doctor, and exhibit misapprehension and distrust regarding trials. Participants perceived this as detrimental to community health and expressed the need for more clarity in clinical trials information and a more fundamental social openness and communication about cancer detection and treatment.
Findings indicate the importance of clinical trials education in both traditional provider referral to trials and also in general patient navigation. To dispel pervasive misapprehension regarding placebos, clinical trials information should emphasize the role of standard care in modern cancer treatment trials. Many participants described willingness to participate in a trial upon physician recommendation, suggesting merit in improving patient-physician communication through culturally competent terminology and trial referral systems.
PMCID: PMC4477827  PMID: 26113749
Racial disparities; cancer; community-based participatory research; clinical research; African Americans
20.  A Community-Based Approach to Enhancing Anal Cancer Screening in Hawaii’s HIV-Infected Ethnic Minorities 
Disparities in anal cancer incidence among Hawaii’s HIV-infected minority population is an emerging health concern. Although anal cytology/anoscopy are effective anal cancer screening tools, social barriers exist that prevent individuals from seeking appropriate care.
Community based participatory research (CBPR) principles were applied to develop resources, including testing a self-obtained anal specimen procedure, to increase anal cancer screening among Hawaii’s underserved/ minority populations.
A team of community members, academic researchers, and health care providers developed culturally-sensitive educational/recruitment materials regarding anal cancer risk targeting underserved/minority HIV-infected individuals. Self- and health care provider (HCP)-obtained anal cancer screening specimens were reviewed for cytology and tested for human papillomavirus DNA. A follow-up evaluation elicited feedback on attitudes and experiences.
Community discussion sessions identified key messages about anal cancer, anal cancer screening, and HPV infection for materials and were used, that successfully recruited 46 individuals (38 males/8 females; 9 Native Hawaiians/Pacific Islanders/Asians, 2 Blacks, 6 Hispanics, 6 American Indian/Alaskan Natives, 23 Whites). Concordance in cytology results between self- and HCP-obtained specimens was moderated (kappa=0.37) with the perception that the self-obtained specimen procedure was private (93%), safe (100%), and easy to manage (100%); and a majority (92%) willing to use the self-obtained method again.
CBPR was a practical approach in engaging Hawaii’s HIV-infected minority participation in anal cancer screening research. Community outreach and recruitment efforts suggested that self-obtained screening specimens could be an acceptable and effective means to reach Hawaii’s HIV-infected ethnic minorities.
PMCID: PMC3614361  PMID: 23560244
Human papillomavirus; Anal neoplasia; Anal dysplasia; Human immunodeficiency virus
21.  Effective recruitment strategies and community-based participatory research: Community Networks Program Centers’ recruitment in cancer prevention studies 
Community-based participatory research (CBPR) approaches that involve community and academic partners in activities ranging from protocol design through dissemination of study findings can increase recruitment of medically underserved and underrepresented racial/ethnic minority populations into biomedical research.
Five cancer screening and prevention trials in three NCI-funded Community Networks Program Centers (CNPCs); in Florida, Kansas and South Carolina, were conducted across diverse populations. Data were collected on total time period of recruitment, ratios of participants enrolled over potential participants approached, selected CBPR strategies, capacity-building development, and systematic procedures for community stakeholder involvement.
Community-engaged approaches employed included establishing co-learning opportunities, participatory procedures for community-academic involvement, and community and clinical capacity building. A relatively large proportion of individuals identified for recruitment were actually approached (between 50% and 100%). The proportion of subjects who were eligible among all those approached ranged from 25% to over 70% (in the community setting). Recruitment rates were very high (78%–100% of eligible individuals approached) and the proportion who refused or who were not interested among those approached was very low (5%–11%).
Recruitment strategies used by the CNPCs were associated with low refusal and high enrollment ratios of potential subjects. Adherence to CBPR principles in the spectrum of research activities; from strategic planning to project implementation has significant potential to increase involvement in biomedical research and improve our ability to make appropriate recommendations for cancer prevention and control programming in underrepresented diverse populations.
CBPR strategies should be more widely implemented to enhance study recruitment.
PMCID: PMC3971731  PMID: 24609851
clinical trials; cancer screening; health disparities; racial/ethnic minority recruitment; community-based participatory research
22.  Community-Based Care for Chronic Wound Management 
Executive Summary
In August 2008, the Medical Advisory Secretariat (MAS) presented a vignette to the Ontario Health Technology Advisory Committee (OHTAC) on a proposed targeted health care delivery model for chronic care. The proposed model was defined as multidisciplinary, ambulatory, community-based care that bridged the gap between primary and tertiary care, and was intended for individuals with a chronic disease who were at risk of a hospital admission or emergency department visit. The goals of this care model were thought to include: the prevention of emergency department visits, a reduction in hospital admissions and re-admissions, facilitation of earlier hospital discharge, a reduction or delay in long-term care admissions, and an improvement in mortality and other disease-specific patient outcomes.
OHTAC approved the development of an evidence-based assessment to determine the effectiveness of specialized community based care for the management of heart failure, Type 2 diabetes and chronic wounds.
Please visit the Medical Advisory Secretariat Web site at: to review the following reports associated with the Specialized Multidisciplinary Community-Based care series.
Specialized multidisciplinary community-based care series: a summary of evidence-based analyses
Community-based care for the specialized management of heart failure: an evidence-based analysis
Community-based care for chronic wound management: an evidence-based analysis
Please note that the evidence-based analysis of specialized community-based care for the management of diabetes titled: “Community-based care for the management of type 2 diabetes: an evidence-based analysis” has been published as part of the Diabetes Strategy Evidence Platform at this URL:
Please visit the Toronto Health Economics and Technology Assessment Collaborative Web site at: to review the following economic project associated with this series:
Community-based Care for the specialized management of heart failure: a cost-effectiveness and budget impact analysis.
The objective of this evidence-based review is to determine the effectiveness of a multidisciplinary wound care team for the management of chronic wounds.
Clinical Need: Condition and Target Population
Chronic wounds develop from various aetiologies including pressure, diabetes, venous pathology, and surgery. A pressure ulcer is defined as a localized injury to the skin/and or underlying tissue occurring most often over a bony prominence and caused, alone or in combination, by pressure, shear, or friction. Up to three fifths of venous leg ulcers are due to venous aetiology.
Approximately 1.5 million Ontarians will sustain a pressure ulcer, 111,000 will develop a diabetic foot ulcer, and between 80,000 and 130,000 will develop a venous leg ulcer. Up to 65% of those afflicted by chronic leg ulcers report experiencing decreased quality of life, restricted mobility, anxiety, depression, and/or severe or continuous pain.
Multidisciplinary Wound Care Teams
The term ‘multidisciplinary’ refers to multiple disciplines on a team and ‘interdisciplinary’ to such a team functioning in a coordinated and collaborative manner. There is general consensus that a group of multidisciplinary professionals is necessary for optimum specialist management of chronic wounds stemming from all aetiologies. However, there is little evidence to guide the decision of which professionals might be needed form an optimal wound care team.
Evidence-Based Analysis Methods
Literature Search
A literature search was performed on July 7, 2009 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, Wiley Cochrane, Centre for Reviews and Dissemination/International Agency for Health Technology Assessment, and on July 13, 2009 using the Cumulative Index to Nursing & Allied Health Literature (CINAHL), and the International Agency for Health Technology Assessment (INAHTA) for studies pertaining to leg and foot ulcers. A similar literature search was conducted on July 29’ 2009 for studies pertaining to pressure ulcers. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established.
Inclusion Criteria
Randomized controlled trials and Controlled clinical Trials (CCT)
Systematic review with meta analysis
Population includes persons with pressure ulcers (anywhere) and/or leg and foot ulcers
The intervention includes a multidisciplinary (two or more disciplines) wound care team.
The control group does not receive care by a wound care team
Studies published in the English language between 2004 and 2009
Exclusion Criteria
Single centre retrospective observational studies
Outcomes of Interest
Proportion of persons and/or wounds completely healed
Time to complete healing
Quality of Life
Pain assessment
Summary of Findings
Two studies met the inclusion and exclusion criteria, one a randomized controlled trial (RCT), the other a CCT using a before and after study design. There was variation in the setting, composition of the wound care team, outcome measures, and follow up periods between the studies. In both studies, however, the wound care team members received training in wound care management and followed a wound care management protocol.
In the RCT, Vu et al. reported a non-significant difference between the proportion of wounds healed in 6 months using a univariate analysis (61.7% for treatment vs. 52.5% for control; p=0.074, RR=1.19) There was also a non-significant difference in the mean time to healing in days (82 for treatment vs. 101 for control; p=0.095). More persons in the intervention group had a Brief Pain Inventory (BPI) score equal to zero (better pain control) at 6 months when compared with the control group (38.6% for intervention vs. 24.4% for control; p=0.017, RR=1.58). By multivariate analysis a statistically significant hazard ratio was reported in the intervention group (1.73, 95% CI 1.20-1.50; p=0.003).
In the CCT, Harrison et al. reported a statistically significant difference in healing rates between the pre (control) and post (intervention) phases of the study. Of patients in the pre phase, 23% had healed ulcers 3 months after study enrolment, whereas 56% were healed in the post phase (P<0.001, OR=4.17) (Figure 3). Furthermore, 27% of patients were treated daily or more often in the pre phase whereas only 6% were treated at this frequency in the post phase (P<0.001), equal to a 34% relative risk reduction in frequency of daily treatments. The authors did not report the results of pain relief assessment.
The body of evidence was assessed using the GRADE methodology for 4 outcomes: proportion of wounds healed, proportion of persons with healed wounds, wound associated pain relief, and proportion of persons needing daily wound treatments. In general, the evidence was found to be low to very low quality.
The evidence supports that managing chronic wounds with a multidisciplinary wound care team significantly increases wound healing and reduces the severity of wound-associated pain and the required daily wound treatments compared to persons not managed by a wound care team. The quality of evidence supporting these outcomes is low to very low meaning that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
PMCID: PMC3377537  PMID: 23074522
23.  Overcoming Recruitment Challenges in Palliative Care Clinical Trials 
Journal of Oncology Practice  2013;9(6):277-282.
Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. Through their experience with designing and deploying a social-marketing based protocol, the authors show that a carefully crafted recruitment and retention protocol can be effective.
Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research—especially participant recruitment—is difficult. Major barriers include (1) patient factors, (2) “gatekeeping,” and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study.
Patients and Methods:
The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of “social marketing,” an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications.
From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%).
Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing–based protocol shows the benefits of such an approach.
PMCID: PMC3825289  PMID: 24130254
24.  Development of a chronic kidney disease patient navigator program 
BMC Nephrology  2015;16:69.
Chronic Kidney Disease (CKD) is a public health problem and there is a scarcity of type 2 CKD translational research that incorporates educational tools. Patient navigators have been shown to be effective at reducing disparities and improving outcomes in the oncology field. We describe the creation of a CKD Patient Navigator program designed to help coordinate care, address system-barriers, and educate/motivate patients.
The conceptual framework for the CKD Patient Navigator Program is rooted in the Chronic Care Model that has a main goal of high-quality chronic disease management. Our established multidisciplinary CKD research team enlisted new members from information technology and data management to help create the program. It encompassed three phases: hiring, training, and implementation. For hiring, we wanted a non-medical or lay person with a college degree that possessed strong interpersonal skills and experience in a service-orientated field. For training, there were three key areas: general patient navigator training, CKD education, and electronic health record (EHR) training. For implementation, we defined barriers of care and created EHR templates for which pertinent study data could be extracted.
We have hired two CKD patient navigators who will be responsible for navigating CKD patients enrolled in a clinical trial. They have undergone training in general patient navigation, specific CKD education through directed readings and clinical shadowing, as well as EHR and other patient related privacy and research training.
The need for novel approaches like our CKD patient navigator program designed to impact CKD care is vital and should utilize team-based care and health information technology given the changing landscape of our health systems.
Electronic supplementary material
The online version of this article (doi:10.1186/s12882-015-0060-2) contains supplementary material, which is available to authorized users.
PMCID: PMC4459709  PMID: 26024966
Chronic kidney disease; Patient navigator; Patient education
25.  Developing an organizing framework to guide nursing research in the Children’s Oncology Group (COG) 
Seminars in oncology nursing  2013;30(1):17-25.
To describe the development and application of an organizing research framework to guide COG Nursing research.
Data Sources
Research articles, reports and meeting minutes
An organizing research framework helps to outline research focus and articulate the scientific knowledge being produced by nurses in the pediatric cooperative group.
Implication for Nursing Practice
The use of an organizing framework for COG nursing research can facilitate clinical nurses’ understanding of how children and families sustain or regain optimal health when faced with a pediatric cancer diagnosis through interventions designed to promote individual and family resilience.
The Children’s Oncology Group (COG) is the sole National Cancer Institute (NCI)-supported cooperative pediatric oncology clinical trials group and the largest organization in the world devoted exclusively to pediatric cancer research. It was founded in 2000 following the merger of the four legacy NCI-supported pediatric clinical trials groups (Children’s Cancer Group [CCG], Pediatric Oncology Group [POG], National Wilms Tumor Study Group, and Intergroup Rhabdomyosarcoma Study Group). The COG currently has over 200 member institutions across North America, Australia, New Zealand and Europe and a multidisciplinary membership of over 8,000 pediatric, radiation, and surgical oncologists, nurses, clinical research associates, pharmacists, behavioral scientists, pathologists, laboratory scientists, patient/parent advocates and other pediatric cancer specialists. The COG Nursing Discipline was formed from the merger of the legacy CCG and POG Nursing Committees, and current membership exceeds 2000 registered nurses. The discipline has a well-developed infrastructure that promotes nursing involvement throughout all levels of the organization, including representation on disease, protocol, scientific, executive and other administrative committees (e.g., nominating committee, data safety monitoring boards). COG nurses facilitate delivery of protocol-based treatments for children enrolled on COG protocols, and Nursing Discipline initiatives support nursing research, professional and patient/family education, evidence-based practice, and a patient-reported outcomes resource center. The research agenda of the Nursing Discipline is enacted through a well-established nursing scholar program.
PMCID: PMC4159101  PMID: 24559776
Childhood cancer; Pediatric oncology nursing; Cooperative group; Nursing research; Clinical trial; Theoretical framework, Resilience

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