Chapter 16. Prevention—Safety and Quality 

Carol Loveland-Cherry 

Background 

To date, the preponderance of research on patient safety and the transformation of the work 

environment has focused on inpatient, acute care settings. Institute of Medicine (IOM) reports1, 2 

clearly recommend that work be done on “studies and development of methods to better 

describe, both qualitatively and quantitatively, the work nurses perform in different care 

settings”2

 (p. 325). Specifically, the recommendation is that research on patient safety needs to 

be addressed across care settings. Preventive services, primary care, and ambulatory care settings 

are areas in which there is a more limited body of work related to patient safety. Yet, these 

nonacute care settings constitute growing loci of health care services. This chapter will review 

the extant research on patient safety in preventive services, primary care, and ambulatory care 

settings. Preventive services, broadly defined, include screening, counseling, and 

chemoprophylaxis. This chapter will not focus on prevention of adverse events in ambulatory 

care or inpatient settings.

The Surgeon General’s report3

 and subsequent plans for ensuring the health of the nation4, 5

emphasize the role of prevention in addressing the leading causes of morbidity and mortality. 

Clinicians play important roles in both primary and secondary prevention.6

 Primary prevention is 

directed at measures to avoid or prevent the onset of disease or adverse condition. Secondary 

prevention focuses on the identification and treatment of asymptomatic individuals who have 

identified risk factors to prevent the development of active disease and/or reduce morbidity and 

mortality. Preventive services encompass health care provided in primary care settings, such as 

office-based practices and clinics, and in community-based settings. Preventive services are less 

regulated and controlled than health care services provided in institutions such as hospitals, longterm care facilities, and nursing homes. Not only have preventive services increased and become 

a central component of primary health care, these services also have become a focus of scrutiny 

in terms of quality and safety6 (p. 13). Screening, counseling, preventive medications, skill 

building, and behavioral change strategies comprise the major foci of preventive services. 

Two national task forces have been charged with the evaluation of preventive services. The 

Agency for Healthcare Research and Quality (AHRQ) convened the United States Preventive 

Services Task Force (USPSTF), an independent body of experts, to evaluate and make 

recommendations for clinical preventive services. The Centers for Disease Control and 

Prevention (CDC) established the Community Task Force to evaluate public health prevention 

programs.7

 Both task forces focus on establishing the efficacy of prevention strategies and also 

consider the relative harms and benefits of preventive services. The recommendations of these 

two task forces are available in print and online (http://www.ahrq.gov/clinic/prevenix.htm; 

http://www.thecommunityguide.org/) and will not be reviewed in this chapter. 

Several IOM reports have emphasized the need to address not only the efficacy and 

effectiveness of health care strategies, but also patient safety.8 The report To Err is Human: 

Building a Safer Health System8

 defines important terms. Safety is defined as “freedom from 

accidental injury” (p. 4) and error as “failure of a planned action to be completed as intended or 

the use of a wrong plan to achieve an aim” (p. 28). Error can occur in either the planning or 

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses

execution of health care services. In preventive services, the challenges are defining and tracking 

safety issues or adverse events. Thus, identification of literature related to patient safety and 

quality of care in preventive services is difficult. Further, with few exceptions, the studies are of 

medical errors. The studies of medical errors and adverse events cover doctors and other primary 

health care providers, such as nurse practitioners. 

The research evidence for patient safety in preventive services falls into five distinct groups: 

identification and classification of errors in primary care, harms of screening, harms of 

information technology, errors arising from language in preventive services, and potential 

interventions to prevent errors and adverse events. The evidence in each of the first four groups 

will be summarized and assessed in this chapter; the potential interventions will be included 

within each of the relevant categories. 

Research Evidence 

Errors in Preventive Services/Primary Care 

In the United States, the literature on patient safety has focused primarily on the inpatient, 

acute care setting. In contrast, a growing literature in the United Kingdom focuses on identifying, 

tracking, and assessing errors in primary care. Seven manuscripts describe some aspect of errors 

in preventive services, primary care, or ambulatory services. The first priority for promoting 

patient safety in primary care was to identify the most common errors that occur in primary 

care.9 

Researchers have used several different methodologies to identify errors in primary care. The 

approaches include observational prospective studies,10, 11 review of malpractice claims,12 reports 

from physicians,13, 14 and interviews with adult patients.15 One systematic review has 

summarized literature in this area published between 1965 and 2001.16 The different 

methodologies, including study length and modes of data collection, make it difficult to compare 

rates of errors or adverse events. The number of events reported were 

• 117 errors for 15 physicians in 83 visits across 7 offices over 3 half-day sessions11 

• 221 incidents from interviews with 38 patients asking them to recall events that occurred 

at any time in the past15 

• 344 incidents from 42 physicians over 20 weeks13 

• 940 incidents over 2 weeks across 10 practices14 

• 805 incidents occurring between October 1993 and June 1995 from 324 physicians10 

• 5,921 incidents from claims data for over a 15-year period12 

• 1,223 incidents from 4 articles published 1995-200216

Regardless of the methodology, similar categories of errors and events were identified and 

patterns emerged that provided the basis for development of classification systems. Dovey and 

colleagues13 developed a taxonomy based on the identified types of errors and sources of errors. 

The most general groupings of errors resulted in two major categories: process errors, and 

knowledge and skills errors. Each of the two categories had three additional levels of specificity. 

For example, a process error in investigating a patient’s condition, specifically in the process of 

laboratory investigations, might involve a wrong test being ordered or a test not ordered when 

appropriate. Bhasale and colleagues10 classified incidents as pharmacological (e.g., inappropriate 

drug), nonpharmacological (e.g., treatment omitted/delayed), diagnostic (e.g., missed), or 

equipment (e.g., malfunction/ineffective). Preventable harms identified by patients were 

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Prevention—Safety & Quality

classified as psychological (e.g., personal worth), physical (e.g., pain) or economic/other (e.g., 

avoidable personal medical expense).15 Elder and colleagues11 described office administration 

errors (i.e., charting, general office administration), physician-related errors, patient 

communication errors, and preventable adverse events. Rubin and colleagues14 noted six 

categories of errors: prescriptions, communication, equipment, appointments, clinical, and 

others. Elder and Dovey16 identified three categories: diagnosis—related to symptoms or 

prevention with either missed or delayed diagnosis; treatment—either drug or nondrug as 

incorrect/inappropriate, delayed or omitted; and preventive services—inappropriate, delayed, 

omitted, or procedural complication. In addition to classifying types of errors, Elder and Dovey 

identified related factors, such as clinician factors (clinical judgment and procedural skills error), 

communication factors (clinician–patient, clinician–clinician/health care system personnel), 

administration factors (clinician, pharmacy, ancillary providers, office setting), and blunt-end 

factors (personal and family issues of clinicians and staff, insurance company regulations, 

government regulations, funding and employers, physical size and location of practice, general 

health care system).16 Kuzel and colleagues15 offered a similar list of access breakdown, 

communication breakdown, relationship breakdown, technical error, and inefficiency of care. 

Bhasale and colleagues10 also identified differences in individuals involved in preventable 

incidents. The incidents involved slightly more females (58 percent) than males and more older 

individuals 25 years and older (around 85 percent) than younger ones. Overall, infants and 

females older than 75 years were overrepresented in the incidents. The same study described 

factors that mitigated the outcomes of adverse events: early intervention by reporting physician, 

patients, patient’s relative, another provider; plain good fortune; patient’s good physical or 

psychological condition; prior experience or training; reliability of professional backup; skilled 

assistant; high awareness via quality assurance activities; and reliability of equipment. 

The data from this group of studies, regardless of the methodology, provide both 

identification of errors or adverse events in preventive services or primary or ambulatory care 

and direction for interventions. Dovey and colleagues’13 major classifications of process and 

knowledge and skills errors provide major conceptual groupings within which to examine the 

specific error identified in the schema. Combined with Bhasale and colleagues’10 identification 

of mitigating factors, this group of studies provides direction for both identifying errors and 

adverse events and for proposing interventions to address them. The findings specific to 

preventive services imply that errors or adverse events result from screening, counseling, or 

chemoprophylaxis being inappropriate, delayed, or omitted, or involve procedural complications. 

These errors or adverse events may arise from either process errors or knowledge and skill 

errors. Process errors are defined as resulting from some aspect of care delivery systems. 111 333

Examples of process errors include care that was provided but not documented in the patient’s 

chart (e.g., a mammogram performed but not recorded) or a medication not being dispensed as 

ordered. Knowledge and skill errors are related to providers’ clinical skills and knowledge (e.g., 

a wrong or missed diagnosis or a wrong treatment based on lack of clinician knowledge). 

The next section examines two groups of studies that represent specific instances of areas 

with potential harms: medication errors and screening activities. 

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses

Adverse Drug Events in Preventive Services/ 

Primary Care/Ambulatory Care 

Twelve studies17–28 examined adverse drug events in primary or ambulatory care. None of 

these studies were specific to chemoprophylaxis. Rather, the foci were similar to those in acute 

care or inpatient care, but occurred in ambulatory or primary care settings. Thus, this group of 

studies was not included in this review as adverse drug events are covered in other chapters in 

this book. 

Potential Harms Related to Screening in Preventive Services 

Screening is a major intervention in preventive services. Although a number of benefits have 

been associated with screening activities in preventive services, risks have also been identified. 

Potential risks of screening include misunderstanding test results, misdiagnosis, mislabeling, 

stigmatization, and decreased psychological well-being.28 Three major reviews30–32 and 10 

studies33–42 examined the benefits, risks, and harms associated with screening activities. The 

most common screening tests reported were for breast, cervical, prostate, and colorectal cancers. 

Screening mammography is recommended for women ages 40 years and older, but there is 

limited evidence for the upper age for screening. There are potential harms associated with 

mammography. The incidence of ductal carcinoma in situ (DCIS) increases in elderly women. 

The risk of death from DCIS progressing to invasive breast cancer is very low; therefore, the 

risks of surgery to treat DCIS outweigh the benefits. Three studies found that approximately 8 

percent of women ages 70 years and older had an abnormal result from mammography, and 85 

percent to 92 percent of those with an abnormal result did not have cancer.31, 33, 35 A slightly 

lower percentage of clinical breast examinations (3.9 percent) resulted in abnormal results, but a 

higher percentage of these women (97 percent) did not have cancer on followup.33 Thus, 

potential harms of screening mammography or clinical breast examination include unnecessary 

biopsy and the stress and worry related to the possibility have having cancer.20 

Similarly, overdiagnosis and overtreatment in 40 percent of women34 are potential harms of 

cervical cancer screening. Results of a cohort study of Pap smear results in postmenopausal 

women 44–79 years of age37, 31 demonstrated a high incidence of false positive results (all but 1 

of 110 abnormal Pap smears). Other harms of Pap smear screening include identification and 

treatment of inconsequential disease, high anxiety, low self-esteem, and disrupted partner 

relationships.31

In addition to the potential harms of psychological distress and false-positive results, 

perforation, bleeding, stroke, myocardial infarctions, Fournier gangrene and thrombophlebitis, 

and treatment of inconsequential disease are harms associated with colonoscopy in 3 of 1,000 

screenings.31 Woolf 36 identified potential harms of PSA testing for men without disease and for 

those with prostate cancer. False-positive results cause unnecessary followup procedures and 

anxiety. Treatment of inconsequential disease results in unnecessary procedures and potential 

complications. 

These potential harms of cancer screening are especially important in decisionmaking for 

elderly individuals, as there are fewer studies and evidence for this segment of the population. 

Based on analysis of all-cause and cancer-specific mortality from the National Center for Health 

Statistics and Surveillance Epidemiology and End Results Survey (SEER), Rich and Black38

concluded that potential harms may outweigh the small benefit of screening for breast cancer, 

4 
Prevention—Safety & Quality

colon cancer, and cervical cancer in elderly individuals. Volk and colleagues39 evaluated a 

patient-educational approach to shared decisionmaking for prostate cancer screening that 

included both potential benefits and harms of screening. The results of the randomized clinical 

trial indicated positive outcomes in terms of increased knowledge and more informed decisions 

regarding prostate cancer screening. Walter and Covinsky40 advocated including potential harms 

in their framework for individual decisionmaking in cancer screening in elderly individuals. 

In summary, harms of various cancer screening procedures have been identified. However, it 

is important to evaluate the potential harms for each procedure relative to the benefits for 

specific age groups and other individual considerations. Thus, the USPSTF recommends routine 

screening mammography for women ages 40 years and older; routine screening for cervical 

cancer in women who have been sexually active and have a cervix, but against routine screening 

for women older than 65; and routine colorectal cancer screening for men and women 50 years 

and older. However, the USPSTF is currently updating recommendations for screening for 

colorectal, cervical, and breast cancer. The USPSTF currently recommends against routine 

screening for pancreatic cancer or ovarian cancer. The task force concluded that there was 

insufficient evidence to recommend for or against routine screening for prostate cancer, skin 

cancer, oral cancer, or lung cancer. 

Errors and Adverse Events Related to Language in 

Preventive Services

A small but interesting group of studies41, 42 and one review43 examined the role of language 

either as a barrier to receiving care or as a factor in adverse events. This area of study is 

particularly relevant given the growth of ethnic populations in the United States. Nearly 20 

percent of U.S. citizens over the age of 5 years speak a language other than English at home.41

However, it is estimated that “more than 50 percent of adults over the age of 18 who speak a 

language other than English at home speak English ‘very well’”41 (p. 254). Lack of proficiency in 

English may result in communication problems with health care providers and decreased 

utilization of care, and it may reflect cultural values and beliefs.42 Results of two studies 

supported the potential for harm resulting from women not receiving preventive services42 and 

infants of parents whose primary language is not English not receiving recommended preventive 

care.

41 Using data from a cross-sectional survey of 22,448 women completing the 1990 Ontario 

Health Survey, logistic regression calculated odds ratios for receiving breast examinations, 

mammograms, and Pap tests for women who reported a language other than English as spoken at 

home versus those who reported English as the primary language, adjusting for socioeconomic 

factors, contact with the health care system, and cultural measures.42 Results indicated that 

women who reported a language other than English spoken at home were less likely to receive 

important preventive services than those who spoke English at home. These findings persisted 

after adjusting for the confounding variables. French-speaking women were less likely to receive 

breast examinations or mammograms, and women speaking other languages were less likely to 

receive Pap tests. 

In a retrospective cohort study of 38,793 year-old infants enrolled in Medicaid, relative risk 

of receiving appropriate and timely preventive care was estimated using multivariate 

regression.41 Primary language of parents, race and ethnicity, rural residence, and managed-care 

plan were independent variables. Results indicated that “fewer than one in six infants enrolled in 

Medicaid in their first year of life received recommended preventive care as defined by the 

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Patient Safety and Quality: An Evidence-Based Handbook for Nurses

[American Academy of Pediatrics]”41 (p. 257). Further, infants whose parents reported that 

English was not their primary language were half as likely to receive recommended preventive 

care. When confounding factors were considered, results indicated that Asian-American infants 

were less likely to experience disparities in preventive care associated with primary language 

than White, Hispanic, and African-American infants. 

While the evidence is limited, the results of these two studies support the potential for 

adverse events resulting from language barriers. An obvious strategy would be to reduce the 

language barriers. A systematic review of the impact of medical interpreter services on the 

quality of health care43 indicated that health care was compromised for patients not proficient in 

English; they were less likely to receive preventive screening, more likely to have a greater 

number of tests done at higher costs; and were less satisfied with care. Additionally, the quality 

of care is further compromised when untrained or ad hoc interpreters, especially children, are 

used. However, availability of trained interpreters was positively associated with obtaining 

preventive screening, such as mammograms. In light of the changing demographics and diversity 

of the U.S. population, this small but growing body of literature on language as a barrier or factor 

in adverse events in preventive services provides another challenge for the health care systems. 

Errors and Adverse Events Related to Information Technology in 

Preventive Services 

A final group of studies explored the impact of the growing use of information technology 

(IT) in health care. IT in health care has been examined from several perspectives. There is a 

literature on the use of e-mail and the Internet by consumers, another on the adoption of IT by 

health care systems, and a third on the unintended consequences of the use of IT in health care. 

Although reports of the extent of use of the Internet and e-mail for health care vary from 35 

percent to 80 percent of adults in the United States,44 the actual and potential impact of IT in 

health care is significant. A survey of a nationally representative sample of 8,935 (69.4 percent 

of a random sample of 12,878) adults age 21 years and over, individuals age 50 and older, and 

veterans identified four frequent uses of the Internet and e-mail.44 The most common use of the 

Internet (reported by 40 percent of respondents) was for information or advice about health or 

health care. This was followed by use of e-mail or the Internet to communicate with family or 

friends about health, use of e-mail or the Internet to communicate with a health care professional, 

and use of these technologies to communicate with other people with similar health conditions. 

However, use of the Internet for health care was a relatively infrequent activity (every 2 to 3 

months or less frequently). Individuals younger than 75 years old and women were more likely 

to use the Internet and e-mail for health. Results also indicated that e-mail and the Internet were 

used most often to gain health-related information and had little effect on the number of contacts 

with health care providers or to obtain a prescription drug. 

IT has been more developed and adopted for financial management than for quality and 

safety purposes.45 Results from a study of IT use in a variety of health care settings in the Boston 

and Denver areas indicate that physician practices (the most common site of preventive services), 

which are generally run as “small independent practices”46 (p. 6), use IT primarily to manage 

billing and schedule patients. Poon and colleagues46 propose that the limited use of electronic 

health records in these practices is related to the perception of limited proven benefits relative to 

the required financial and time commitments needed. 

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Prevention—Safety & Quality

Based on results from separate qualitative studies, Ash, Berg, and Coiera47 presented 

evidence that implementation of electronic patient care information systems (PCISs) in many 

instances appears to promote rather than limit errors. They argued that factors, including the 

complexity of PCISs and the physical space and other system characteristics, contributed to the 

occurrence of “unintended consequences”47 (p. 104). The authors identified errors in two general 

areas: process of entering and retrieving information, and communication and coordination 

processes. They attributed errors in entry and retrieval of information to the high level of 

interruption and “cognitive overload” related to practice environments. Further, the authors 

proposed that errors in communication and coordination were related to the assumptions of a 

linear workflow and communication as information transfer. They advocated for educating 

health care providers to have a critical approach to PCISs, that developers and vendors of PCISs 

be clearer about the limitations of the systems, and that clinicians be supported in continuing 

interactions that are part of monitoring the safety of clinical systems. 

Research that evaluates the ability of IT systems to promote patient safety and reduce errors 

is limited but growing,45 especially in preventive services. Five studies48–52 examined the use of 

an electronic health record system to generate physician, telephone, and letter reminders for 

patients to obtain preventive services. Results indicated that all three types of reminders were 

effective. There is evidence supporting the reduction of medication errors and adverse events 

through the use of computerized physician order entry and online decision support.53 Bakken and 

colleagues54 advocated the use of informatics to address errors associated with impaired access 

to information through the use of personal digital assistants, to address communication failures 

associated with adverse events, to promote the use of standardized practice patterns, and to 

provide automated surveillance to detect and prevent real-time errors. The proposed approaches 

have direct application in preventive care settings. 

Evidence-Based Practice Implications 

The evidence on errors and adverse events in preventive care provides preliminary direction 

for practice. Few if any studies proposed or evaluated approaches to avoid or reduce errors and 

adverse events in prevention. However, a growing number of studies have evaluated strategies to 

reduce errors and adverse events in acute, inpatient, ambulatory, primary, and home care, and 

they provide potential direction for prevention as the field matures. Leape’s55 directives—

identify what works, ensure that the patient receives it, and deliver it flawlessly—are relevant for 

ensuring safety in prevention. At this point, perhaps the most viable approach to assure patient 

safety in prevention practice is use of the guidelines of the USPSTF, AHRQ, the Community 

Task Force, and CDC. 

Research Implications 

The greatest challenge in patient safety and quality in preventive care is the lack of a strong 

body of evidence on which to base our understanding of errors and adverse events in prevention 

and, more broadly, in ambulatory and primary care settings. Research in preventive care is 

limited relative to that in acute care, inpatient settings, and home care. The focus has been on 

research evaluating the efficacy of preventive services, which includes an evaluation of the 

potential and actual harms of the services in order to determine the net benefit. While there is a 

growing body of evidence for safety and quality in health care in primary and ambulatory 

7 
Patient Safety and Quality: An Evidence-Based Handbook for Nurses

settings, there is very limited literature on harms or adverse events in preventive care and how to 

avoid them. Additionally, much of the research is observational and descriptive, with few 

interventions being tested. The research on identifying and describing errors in primary and 

ambulatory care has relevance for preventive care. However, there is a need for research directed 

at explicating errors and adverse events in preventive care. 

Once the types of errors and adverse events have been identified and described, then research 

describing the factors associated with these events is needed. Further, there is limited evidence 

on basic questions, such as when to begin or discontinue screening, chemoprophylaxis, or 

counseling and implications for adverse events or potential harms. Only then can nurses and 

other health care professionals develop and test strategies to reduce risk related to preventive 

services. For example, the evaluation of the use of IT to decrease risks and adverse events is a 

major focus in acute care, ambulatory care, and primary care settings. Would the use of IT 

approaches be appropriate in preventive services? How can the human factor principles of 

standardization, simplification, and use of protocols and checklists55 be facilitated by the use of 

IT in prevention? Finally, the difficulties inherent in research on preventive services present 

significant challenges, including timing of services and consideration of contextual factors (age, 

culture, race/ethnicity, gender, setting, etc.). 

Thus far, the evidence presented attempts to answer the following: (1) How do errors and 

adverse events in prevention differ from those for other types of health care services? (2) How do 

contextual factors contribute to potential errors and adverse events in prevention? and (3) What 

are potential areas of research for nursing that would contribute to addressing patient safety in 

prevention? The following areas are the critical research gaps: 

• Descriptive data on errors and adverse events in preventive services 

• Data on factors related to errors and adverse events in preventive services 

• Evaluation of interventions to reduce errors and adverse events in preventive services. 

Conclusion 

The limited body of evidence on errors and adverse events in preventive services, especially 

from a nursing perspective, supports the need for additional research to move ahead in the area 

of patient safety. It is likely that some of the evidence from studies in ambulatory and primary 

care will provide direction for research and subsequent evidence-based practice in preventive 

care. However, there may be unique errors and adverse events associated with preventive 

services. It is clear that there is potential for errors and adverse events in preventive services, but 

additional evidence is needed to explicate what they are. The evidence that is available is largely 

from either descriptive studies or from randomized controlled trials (RCTs) examining the 

efficacy of preventive services, specifically in cancer screening. There is less systematic 

evaluation of counseling interventions for prevention. The nature of preventive services and their 

outcomes and where they are delivered increase the complexity of both establishing an evidence 

base and implications for practice. The continued evaluation of using information technology to 

address risks and adverse events is a promising area for study and practice. 

The focus in safety and quality research in health care has been on preventable events rather 

than on preventive services. Screening, counseling, and chemoprophylaxis are the key elements 

of preventive services. The evidence base on errors and adverse events in preventive services is 

limited and needs to be developed to provide direction for practice. 

8 
Prevention—Safety & Quality

Search Strategy 

A search of the CINAHL®, Ovid MEDLINE®, Cochrane Database of Systematic Reviews 

electronic databases, and the AHRQ Web site from 1990 to 2006 was conducted using the 

following search terms: patient safety, safety, quality, preventive services. The search was 

further limited to research studies and reviews. A total of 115 references were identified and the 

abstracts reviewed. The criteria for inclusion in the review for this chapter were (1) systematic 

review of published research; (2) nonsystematic review of published research; and (3) published 

research that used randomized control, comparison, and pretest–post-test no control designs. 

Based on the review of the abstracts using these criteria, 6 reviews, 10 commentary or 

background articles, and 32 studies were selected for inclusion in the review. 

Author Affiliation 

Carol J. Loveland-Cherry, Ph.D., R.N., F.A.A.N., professor and executive associate dean, 

University of Michigan School of Nursing. E-mail: Loveland@umich.edu. 

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2003;139(10):835-42. 

33. Tabar L, Vitak B, Chen HH, et al. The Swedish TwoCounty Trial twenty years later. Radiol Clin N Am 

2004;11:126-9. 

34. Bonneux L, Raffle AE, Quinn M, et al. Harms and 

benefits of screening to prevent cervical cancer. 

Lancet 2004;364:1483-6. 

35. Kerlikowske K, Salzmann P, Phillips KA, et al. 

Continuing screening mammography in women aged 

70 to 79 years: impact on life expectancy and costeffectiveness. JAMA 1999;282(22):2156-63. 

36. Woolf SH. Public health perspective: the health policy 

implications of screening for prostate cancer. J Urolog 

1994;152:1685-8. 

37. Sawaya GF, Grady D, Kerlikowske K, et al. The 

positive predictive value of cervical smears in 

previously screened postmenopausal women: the heart 

and estrogen/progestin replacement study (HERS). 

Ann Intern Med 2000;133(12):942-50. 

38. Rich JS, Black WC. When should we stop screening? 

Eff Clin Pract 2000;3(2):78-84. 

39. Volk, RJ, Cass AR, Spann SJ. A randomized 

controlled trial of shared decision making for prostate 

cancer screening. Arch Fam Med 1999;8:333-40. 

40. Walter LC, Covinsky KE. Cancer screening in elderly 

patients: a framework for individualized decision 

making. JAMA 2001;285(21):2750-6. 

41. Cohen AL, Christakis DA. Primary language of parent 

is associated with disparities in pediatric preventive 

care. J Pediatr, 2006;148:254-25. 

10 
Prevention—Safety & Quality

42. Woloshin S, Schwartz L, Katz SJ, et al. Is language a 

barrier to the use of preventive services? J Gen Intern 

Med 1997;12:472-7. 

50. Rosser WW, Hutchinson BG, McDowell I, et al. Use 

of reminders to increase compliance with tetanus 

booster vaccination. CMAJ 1992;146(6): 911- 7. 

43. Flores G. The impact of medical interpreter services 

on the quality of health care: a systematic review. Med 

Care Res Rev 2005;62:255-99. 

51. McDowell I, Newell C, Rosser W. Comparison of 

three methods of recalling patients for influenza 

vaccination. CMAJ 1986;135(9):991-7. 

44. Baker L, Wagner TH, Singer S, et al. Use of Internet 

and e-mail for health care information. JAMA, 

2003;289(18):2400-6. 

52. Rosser WW, McDowell I, Newell C. Use of reminders 

for preventive procedures in family medicine. CMAJ 

1991;145:807-14. 

45. Poon EG, Jha AK, Christino M, et al. Assessing the 

level of healthcare information technology adoption in 

the United States: a snapshot. BMC Medical 

Informatics and Decision Making 2006;6:1. 

53. Koshy R. Navigating the information technology 

highway: computer solutions to reduce errors and 

enhance patient safety. Transfusion 2005;45:189S205S. 

46. Ash JS, Berg M, Coiera E. Some unintended 

consequences of information technology in health 

care: the nature of patient care information systemrelated errors. J Am Med Inform Assoc 

2004;11(2):104-12. 

54. Bakken S, Cimino JJ, Hripcsak G. Promoting patient 

safety and enabling evidence-based practice through 

informatics. Med Care 2004;42(2): II-49-56. 

55. Leape LL, Berwick DM, Bates DW. What practices 

will most improve safety? Evidence-based medicine 

47. Shekelle PG, Morton SC, Keeler EB. Costs and meets patient safety. JAMA 2002;288(4):501-7. 

benefits of health information technology. Evidence 

Report/Technology Assessment No. 132. (Prepared by 

the Southern California Evidence-based Practice 

Center under Contract No. 290-02-0003.) Rockville, 

MD: Agency for Healthcare Research and Quality; 

April 2006. AHRQ Publication No. 06-E006. 

56. Barratt AL, Irwig LM, Glasziou PP, Salkeld GP, 

Houssami N. Benefits, harms and costs of screening 

mammography in women 70 years and over: a 

systematic review. MJA. 2002; 176: 266-272. 

57. Barton MB. Breast cancer screening: benefits, risks, 

and current controversies. Postgrad Med. 2005; 

118(2): 27-36. 

48. McDowell I, Newell C, Rosser W. A randomized trial 

of computerized reminders for blood pressure 

screening in primary care. Med Care 189;27(3): 297-

305. 58. Hibbard JH, Stockard J, Tusler M. It isn't just about 

choice: the potential of a public performance report to 

affect the public image of hospitals. Med Care Res 

Rev. 2005; 62(3):358-71. 

49. McDowell I, Newell C, Rosser W. Computerized 

reminders to encourage cervical screening in family 

practice. J Fam Pract 1989;28(4):420-4. 

11 
Evidence Table. Prevention—safety and quality 

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Ash 200446 Patient care information system-related (PCISs) errors Literature review, nonsystematic, and series of qualitative studies Qualitative studies (5) impact of PCISs in health care and unintended outcomes (2). Health care delivery settings and interviews with professionals in the United States, Netherlands, and Australia None Types of e

and retrievjuxtapositifor or on bcognitive oand coordinflexibilitytransfers, loss of feeoverload, multidiscip

Baker 200344 Use of Internet and e-mail for health care information Cross-sectional study National survey of Internet use for health care and prevalence of e- mail use for health care (5). Use of Internet and e-mail for health care and effects on knowledge of health care and use of health care system (3). 4,764 individuals ages 21 years and older who were self- reported Internet users drawn from a research panel of more than 60,000 U.S. households Internet and e- mail use ~40 perce

Internet acfor advice health or he-mail to cprofessionhealth rephealth carhealth carreported nvisits and number of percent reobtain prepharmace

12
13

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Bakken 200454

Use of informatics to promote patient safety and enable evidencebased practice 

Literature review, nonsystematic 

Literature review, nonsystematic (6). Patient safety and evidencebased practice (3). 

Review of literature on informatics infrastructure for patient safety and evidence-based practice 

None Examples 

informatics integrated based praobjectives informatiosurveillancdetection acommunicthe health standardiz

Barratt 200256 

Harms of screening mammography 

Systematic literature review 

Decision-analytic, costeffectiveness models; quality of life and life expectancy 

Australian women 70 years and older 

None Five mode

two includexpectancmammogrincreasing percent wiadjustmen9,600 of 1not have bhave furthundergo bcancers dewill be DCyear = $8,cost-effectmortality fmorbidity. 

Barton 200557

Risk factors for breast cancer 

Literature review, nonsystematic/ narrative 

Accepted screening methods and new technologies 

Women in the United States 

None False-pos

after 10 scwith transfMRI more times the ncancer; hig
14

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Bhasale 199810

Incident monitoring of potential harm in general practice 

Noncomparative study 

Observational study (5). Reports of number and type of incidents, contributing factors, mitigating factors, additional resource use (Level 1). 

324 general practitioners (GPs) from nonrandom sample of Australian GPs 10/93–6/95 

None 805 incide

preventabsevere ha66 percenpharmacononpharmdiagnosis, common ccommunicand health actions of judgment. 

Brawley 200530

Biases, harms, accuracy of cancer screening 

Literature review, nonsystematic/ narrative 

Nonsystematic literature review (6). Harms of screening (2). 

Review of screening modalities for specific cancers, including potential harms and accuracy of screening 

None Biases – s

harms – ctrue-positivlabeling, msensitivitypredictive value; bre– repeat mbiopsy; ovevaluationclinically in

Brown 200620

Pharmacistphysician relationship in detecting ambulatory medication errors 

Noncomparative study 

Observational study without controls (5). Data pharmacist’s role, responsibilities, and expectations to inform physicians about medication errors (3). 

Focus groups with 30 pharmacists and 31 patients in community pharmacies in Mississippi 

None Ambulator

link betwemultiple phpatient edinterceptoerrors; hesphysiciansbarriers. 
15

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Cohen 200641 Disparities in pediatric 

preventive care associated with primary language of parent 

Retrospective cohort study 

Review of Medicaid data (5). Appropriate and timely receipt of six preventive care visits in first year of life (2). 

Review of records for 38,793 Medicaid -enrolled 1-year-old infants in Washington State 

Primary language of parent 

Infants of language as likely to preventive white, HispAmerican infants. 

De Smet 200428 Repeat prescribing Systematic literature review Repeat prescribing in 

ambulatory care patients: definition and scale of repeat prescribing; problems with repeat prescribing and areas for improvement; characteristics and results of intervention studies; conclusions and recommendations for future research (3). 

Ambulatory care patients 

Review of medications by pharmacist; feedback to patient and physician; home inventory of medications; monthly dispensing with protocol led to check on drugrelated problems; chart review; written feedback by physician 

Repeat prpercent to without diroverall intepharmacecompliancquality-of-consumptnot observimprovemscore, lipid inapproprioutpatientsome shownumber of units, and 
16

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Dovey 200213

Medical errors in family practice 

Noncomparative study 

Observational study without controls (5); “error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim”; “safety is defined as freedom from accidental injury”; “anything that happened in your own practice that should not have happened, that was not anticipated, and that makes you say ‘that should not happen in my practice and I don’t want it to happen again’” (1). 

42 family physicians from the National Network for Family Practice and Primary Care Research 

Preliminary taxonomy of medical errors in family practice 

330 error layered taand knowlknowledge failing to mphysicians patients beat home; pdelivery prmiscommunone, care financial aphysicianslost trust in not regain hospital, o
17

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Elder 200216

Errors and preventable adverse event from medical care in outpatient primary care settings 

Systematic literature review 

Systematic review of original research (7 studies); process errors and preventable adverse events (1). 

Seven studies from family practice, ambulatory care, primary health care 

Classification of preventable adverse events (PAE) and process errors in primary care 

Limited nuclassificaticategories (misdiagnoor preventnondrug), (inapproprproceduraattributablerrors: clinjudgment, communicpatient, clicare systeadministrapharmacysetting), band family staff, insurregulationfunding anand locatiohealth car

Elder 200411

Errors and preventable adverse events by family physicians in outpatient visits 

Noncomparative study 

Observational study without controls (5). Errors and preventable adverse events, patient harm (1). 

15 family physicians in 7 practices in Cincinnati area 

None 117 errors 

events; moadministrageneral ofphysician-communicminor phyadverse dphysical inprogressiocommon ewasted timharms devdisease, pprogressiointeractionoutcomes 
18

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Field 200424 Strategies for identifying 

adverse drug events (ADEs) 

Prospective cohort study 

Observational study without controls (5); drug/drug-related incidents (1). 

31,757 Medicare enrollees in large multispecialty group practice in New England over 12 months 

None 1,523 ADE

preventab

values fo

highest praccounted ADEs and ADEs, hosvery low Psignals acADEs and ADEs, elefor 35 percpercent of overlap in sources; emore ADEmultiple so
19

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Flores 200543

Effect of medical interpreter services on health care quality 

Systematic review Systematic 

review of 36 studies (RCT, descriptive, qualitative, survey) on LEP (limited in English proficiency) (1). Quality of health care and errors related to use of interpreters; communication issues; patient satisfaction with care; and processes, outcomes, complications, and use of health services (2). 

Urban emergency department, hospitals, physician offices 

None Lack of int

self-reportdiagnosis hoc interpup to half questions, errors with consequennot mentioeffects, anissues whinterpreteraffects compsychiatric positive efand an adand no intproviders yield higheInterpreterpreventive disparities with interpoffice visitwritten and of phone cphone calControverLEP with nhave more costs, morhydration, hospitaliza
20

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Gandhi 200319 Adverse drug events in primary 

care 

Prospective cohort study 

Observational study without controls (5). Adverse drug events (1). 

Survey of 661patients who received at least one prescription during a 4-week period (55 percent response rate) and chart review at four adult primary care practices in Boston (two hospital based and two community based) 

None 25 percen

181 adver(24) seriouameliorabpreventabpercent atfailure to rrelated sympatient’s faof symptommedication serontoninpercent), bangiotensiinhibitors (anti-inflamMultivariatof medicatassociated 

Gandhi 200526 Outpatient prescribing errors Prospective cohort study Observational study without 

controls (5). Adverse drug events (1). 

Outpatients over age 18 who received a prescription from 24 participating physicians in 4 adult primary care practices in Boston using prescription review, patient survey, and chart review 

None Screened 

1,202 patipercent represcriptioerror, 3 erADEs, and patient injupotentially (24 percenmedication ADEs not basic comvs. handwchecks copercent of prescribing outpatient 
21

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Glassman 200627

Effects of automated drug alerts on clinicians’ knowledge and perceptions 

Pretest and post-test study 

Observational study with controls (4). Increased recognition of selected interacting dug pairs and perceptions of computerized order entry (3). 

97 clinicians (82 physicians and 15 nurse practitioners/physician asst) in ambulatory settings in Southern California Veterans Affairs Healthcare System 

Interval (~2 years) exposure to automated drug alerts via computerized patient record system (CPRS) 

Clinicians interacting drug-drug recognition drug-drug improved; order entry (63 percencommon bsystem waratio or too 

Gurwitz 200317 Adverse drug events among 

older person in ambulatory setting 

Retrospective cohort study 

Observational study without controls (5). Adverse drug events (1). 

Medicare enrollees cared for by multispecialty group practice during a 12-month period 

None 1,523 adv

percent (4578 (38 peserious, lifoverall ratevents/1,013.8 preveevents/1,0occurred mprescribing monitoring percent of adherencemedication cardiovascdiuretics (2analgesics hypoglyceanticoagu
22

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Hibbard 200558 

Medical errors Cross-sectional Assess the 

effectiveness of 12 recommendation actions form AHRQ’s 20 tips; respond to scenarios of 29 different possible medical errors; response to terms patient safety and medical errors; how effected are recommended actions; how likely are consumers to engage in actions. 

195 consumers of medical care recruited from University of Oregon classified staff, mean age 42, 71 percent female, 81.5 percent Caucasian, 12 percent high school graduates, 55.4 percent college graduates, 14 percent listed health as fair or poor, 44 percent reported they or family member had experienced a medical error. 

None Patient sa

serious prof a problepercent nolikely to enrecommennewer recthose actio(2.6). Self-of action rengage in 

Hicks 200625

Medication errors in children 

Retrospective cohort study 

Observational study without controls (5). Harmful medication errors in children (1). 

Data from voluntary medication error reporting system (MEDMARX®) over 5 

years for individuals <17 years old

None 816 harmf

medicationaccounted wrong doscommon; analgesics antimicrobantidiabetfluids and 
23

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Kerlikowske 199935

 Cost effectiveness and impact on life expectancy of mammography screening in women 70–79 years 

Noncomparative study 

Decision analysis and costeffectiveness analysis using a Markov model (4). Deaths due to breast cancer averted, life expectancy, cost effectiveness (2). 

General population of women 65 and older 

Outcomes of screening mammography based on three screening strategies 

Continuing bone minequartiles p~2.1 days incrementlife saved; women to additional adds 7.2 hwith increm$117,689/to prevent at reasonaharms of sIncidence age with 2DCIS in elrate of surinsignificawomen agabnormal percent wihave canc

Koshy 200553

Medical errors and patient safety 

Literature review, nonsystematic/ narrative 

Review of literature (5). Computer solutions to medical errors and patient safety (2). 

Biometrics data base; biometrics – fingerprints, CPOE (computerized physician order entry), DSSs (decision support systems) 

None Proposed 

System – access to informatioelectronic Recommeprevention adequate assure safproposes systems frinformatiodatabase 
24

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Kralewski 200522

Influence of structure and culture of medical group practices on prescription drug errors 

Retrospective cohort study 

Observational study without controls (5). Influence of structure and culture of medical group practices (3). 

Care Plus claims data, prescription drug error rates at enrollee level aggregated for 78 group practices in upper Midwest, ambulatory care 

None 30 percen

written flag~half of erunderdoseerrors – phoutpatient lower erroin rural arerates; urbaerror ratesautonomy incentive uinformatiowith lower culture vavariance. 

Kuzel 200415

Medical errors in primary care 

Noncomparative study 

Observational study without controls (5). Stories of preventable problems with primary care that led to physical or psychological harm (1). 

38 in-depth anonymous interviews with adults from rural, suburban, and urban locales in Virginia and Ohio 

None 221 proble

37 percenbreakdownrelationshinvolved bclinicians; perceived 170 report70 percen

Mandelblatt 200332

Cost effectiveness of screening mammography beyond age 65 and potential harms 

Systematic literature review 

Systematic review (1). Cost-benefit analysis, cost effectiveness, life-years gained, and costs per person of biennial screening after age 65 (2). 

Women 65 years and older; costeffectiveness articles published between January 1989 and March 2002 

None 115 studie

criteria; In~$34,00 to saved aftescreen if hscreened harms not study; poteanxiety asresults, miknowledge with consequality of l
25

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Mayo 200418

Nurses’ perceptions of medication errors made by nurses 

Noncomparative study 

Observational study without controls (5). Perceptions of medication errors (1). 

Random sample of 983 acute care nurses in Southern California; self-report survey 

None Causes of 

writing is dnurses are nurses are confusion similar namthe dose, wrong dospatient’s nmedication nurse sets device inclabels/pacor damagedifferent tyinfusion denurse beliereported; rinclude feareactions. 

McDowell 198651 Comparison of methods for 

recalling patients for influenza 

Randomized clinical trial 

Randomized clinical trial comparing three methods of reminding patient to receive influenza vaccination (2). Influenza vaccination rates (3). 

939 patients ages 65 years and older in four family practices in Canada 

Personal reminder by physician vs. telephone reminder by nurse vs. reminder by letter vs. no reminder 

Vaccinatiophysician nurse remletter remireminder; generated medical re

McDowell 198949 Computerized reminders for 

cervical screening 

Randomized clinical trial 

Randomized clinical trial (2). Cervical screening rates (3). 

1,587 women ages 18–35 overdue for a screening test in family medicine center in Canada 

Personal reminder by physician vs. telephone reminder by nurse vs. reminder by letter vs. no reminder 

Screening physician letter remireminder, reminder; generated medical re
26

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

McDowell 198948 Computerized reminders of 

blood pressure screening in primary care 

Randomized clinical trial 

Randomized clinical trial (2). Blood pressure screening rates (3). 

8,298 patients ages 18 and older who had not had a blood pressure measurement during the previous year, from large family practice in Canada 

Computergenerated reminder to physician to check blood pressure during visit vs. telephone reminder by nurse vs. reminder by letter vs. normal care control 

Screening physician letter reminurse remreminder; generated medical re

Metlay 200523 Medication-taking practices on 

high-risk medications in home-based older adults 

Noncomparative study 

Observational study without controls (Level 4). 

Telephone survey of 4,955 communitydwelling older adults in Pennsylvania in PACE (a State insurance program) program 

None 32 percen

specific inmedicationinstructionprovider apharmacisto organizwarfarin mreceiving idigoxin or 
27

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Phillips 200412 Malpractice claims in primary 

care 

Retrospective cohort Observational 

study without controls (4). Review of malpractice claims data 1985–2000 from Physician Insurers Association of America (4). 

49,345 primary care claims; 26,126 peer reviewed, 5,921 assessed as negligent 

None No single 

percent, inpractice/gecommon tDiagnostic or monitor performanfailure/delaperformedindicated, delay in peadmission recognize treatment. records, cdischarge error, vicacommunicothers; simKingdom. 
28

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Poon 200646

Health care information technology (HIT) adoption 

Multisite qualitative study 

Multisite qualitative study; survey of electronic results review, CPOE, EHR (electronic health record), claims and eligibility checking, patientdoctor electronic communication, provider to provider electronic communication. Modified Delphi approach to obtain national estimates (5), adoption of HIT in two markets: Boston and Denver (4). 

Key informants from stakeholder groups in each city 

None 52 of 119 

percent) afunctionalireimbursedeveloped safety and national esfrom Bostobarriers; H

Quaid 199329 Psychological and ethical 

considerations in screening for disease 

Literature review, nonsystematic 

Nonsystematic review (6). Potential harms of screening (2). 

Nonsystematic literature review of potential risks of screening for disease 

None Risks inclu

test resultsstigmatizapsychologmay be minsurance should not certain safclinicians aeducated benefits; uvalid, and obtain infosurveillancright to priimplement
29

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Rich 200038 Screening for 

breast, cervical, and colon cancer 

Cross-sectional study Model days of life 

lost by stopping screening at various ages using SEER data (5). Days of life lost by stopping screening at various ages (1). 

Randomized trial data, model using life tables to calculate life expectancy at various ages for stopping screen and for continuing until death for breast, cervical, and colon cancer 

Stopping screening at various ages 

Start age opotential li43 days fofor colon cmaximum days; 80 pachieved bcancer, 80 and 65 yeSmall benharms of aand unnec

Rosser 199152

Reminders for preventive procedures 

Prospective randomized controlled study 

Prospective randomized controlled study (2). Completion of preventive procedures (2). 

8,502 patients 15 years or older not in a hospital or institution; 5,883 randomly assigned by family to a control, physician reminder, or telephone or letter reminder group; 2,619 not assigned to group but monitored 

During 1 year patients in active reminder groups received a telephone or letter reminder of any overdue preventive procedures,and those in passive groups received a physician reminder vs. no reminder 

All three redelivery of completion letter remiphysician control grocomputer 

Rosser 199250

Reminders of tetanus booster vaccination 

Prospective randomized controlled study 

Prospective randomized controlled study (2). Proportion of patients receiving tetanus toxoid during study year or had claim of vaccination in previous 10 years (2). 

8,069 patients 20 years or older not in a hospital or institution – 5,589 randomly assigned to control, physician reminder, telephone reminder, or letter reminder group; 2,480 patients not randomized but monitored 

No reminder vs. physician reminder at office visit vs. telephone reminder vs. letter reminder 

Rates of revaccinationo remindphysician telephone letter remisystems wand increavaccinatioachieving coverage. 
30

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Rubin 200314 Errors in general practice Noncomparative study Observational study without 

controls (5). Staff reported errors – classification and frequency (1). 

5 physicians, 1 nurse, 1 pharmacist, and 11 administrative staff from 19 practices in UK general practice, North East of England 

Error classification 

940 errors communicappointme75.6/1,000 administraprescriptiopercent re

Shekelle 200647

Costs and benefits of health information technology (HIT) 

Systematic review of studies related to HIT systems in all care settings 

Systematic review of studies (meta-analysis, systematic review, original research) (1). Costs and benefits of HIT for pediatric care; ability of one aspect of HIT – the electronic health record (EHR); costs and cost effectiveness of implementing EHR; effect of HIT on making care more patient centered (2). 

256 articles of 855 screened from electronic search of articles published 1995 to January 2004 

None 156 studie

84 assesscomputeri(CPOE); 1ambulatoror inpatienrandomizeclinical tria20 time seconcurrentesting stucost data. systems (Cdosing errreduce incmedication pediatric asettings; esavings in promisingsystems is show decroverused orders for 3–13 yearevidence oBarriers to situationalliability, anPotential tcare, but levidence. 
31

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Sawaya 200037

Positive predictive value of cervical smears in previously screened women 

Randomized controlled study 

Prospective cohort study and randomized double-blind, placebocontrolled trial (2). Positive predictive value of cervical smears and the effect of oral estrogen plus progestin on incident cervical cytologic abnormalities (1). 

2,561 women with a uterus and normal cytologic characteristics at baseline in 20 U.S. outpatient and community clinical centers 

Annual smear; oral conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, or identical placebo 

Incidence abnormalismear was women widiagnosesdysplasia; of any smeafter normyears was cervical smwarranted cytologic rwomen. 

Tabar 200433 Efficacy of breast cancer screening 

by age

Randomized controlled trial 

Clinical trial of breast cancer screening (2). Mortality (1). 

133,065 Swedish women ages 40–74 with 13-year followup of 2,467 cancers 

Breast cancer screening 

30 percenassociated 40–74 aftewomen 50women 40mortality in prognostic lymph nodtype. 

Triller 200521

Prevalence of risk factors for adverse drug events (ADEs) 

Retrospective cohort study 

Observational study without controls (5). Risk factors for ADEs (2). 

Data on 10 risk characteristics of patients at point of discharge discharged in 2000 to home health care, self-care, long-term care 

None Data on 4

characterigroups: hoprevalence cardiovascpoly pharmhighest prhypoalbumimpairmenuse. 
32

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Volk 199939 Shared 

decisionmaking for prostate cancer screening 

Randomized controlled trial 

RCT with preoffice visit assessment and 2-week followup (2). Patients’ core knowledge of prostate cancer, reported preferences for PSA testing, and ratings of videotape (3). 

160 men ages 45–70 with no history of prostate cancer or treatment, from university-based family practice center 

Patienteducational approach to shared decisionmaking for prostate cancer – PSA videotape 

Significant about prosmortality, ptesting, tredisadvantasignificant preference

Walter 200531 Extrapolation to older person of 

efficacious screening tests for cancer, harms 

Literature review, nonsystematic 

Nonsystematic literature review (6). Surrogate outcomes (2). 

Review of evidencebased literature None Few scree

>70; questo extraposcreening Are there of cancers reduce the detection/tdifferencescreening make tests cancer? Aindividual people thabenefit frolikelihood Potential cidentified (complicatidistress, foanxiety). Sis individupotential b
33

Source Safety Issue 

Related to 

Clinical Practice 

Design Type Study Design, 

Study Outcome 

Measure(s) 

Study Setting and 

Study Population 

Study 

Intervention 

Walter 200140

Framework for individualized decisionmaking for cancer screening 

Cross-sectional study Description 

of development of framework (6). Potential benefits and harms of screening (1). 

Elderly individuals (50–90 years old); use of life expectancy tables and published data 

Development of framework for individualized decisionmaking 

Potential bnumber neone cancein potentiasimilar ageexpectancto derive a harms – gcancers thclinically sscreeningdecisionmpatient’s v

Woloshin 199742 Main spoken language as 

barrier to preventive services 

Cross-sectional survey 

Self-report of breast examination, mammogram, and Pap test (20). 

22,448 women completing 1990 Ontario Health Survey, populationbased random sample of households 

Language spoken 

French-spwho spoke English weimportant