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Biomedical subjects

Jim Nuovo

Publications and source records attributed to Jim Nuovo.

9 recordsLinked to original sources
PubMed2007

Reporting adverse events in randomized controlled trials.

PURPOSE: How randomized controlled trial results are reported may minimize concerns and detection of adverse side effects. We aimed to describe the methods of reporting adverse events in these published trials. METHODS: Five frequently cited journals were investigated: Annals of Internal Medicine, British Medical Journal, JAMA, The Lancet, and the New England Journal of Medicine. For each journal, all randomized controlled trials conducted on the use of a medication were selected from January 2000 through June 2003. All issues of each journal were reviewed manually. Information retrieved included any mention of adverse events in the abstract, methods, results, or discussion section of the article; or inclusion of adverse events data in tables or figures. We also cataloged whether there was a separate subheading in the results section for reporting adverse events. Reports of trials that referred to methods described in a previous report were excluded. RESULTS: There were 521 eligible articles. Explicit mention of adverse events was in 328 (63%) of abstracts (range 47-66%), 380 (73%) of methods (range 51-81%), 464 (89%) of results (range 80-95%), and 250 (48%) of tables (range 31-49%). There was a separate subheading for adverse events in 240 (46%) (range 22-64%) of the eligible articles. CONCLUSION: There is variation among authors and journals as to the location of reporting adverse events and the means by which it is done. Authors and editors should include specific information on adverse events when reporting the results of randomized controlled trials. It would be ideal if there was more consistency among authors and journals as to how these adverse events are described.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Assessing resident's knowledge and communication skills using four different evaluation tools.

PURPOSE: This study assesses the relationship between 4 Accreditation Council for Graduate Medical Education (ACGME) outcome project measures for interpersonal and communication skills and medical knowledge; specifically, monthly performance evaluations, objective structured clinical examinations (OSCEs), the American Board of Family Practice in-training examination (ABFP-ITE) and the Davis observation code (DOC) practice style profiles. METHODS: Based on previous work, we have DOC scoring for 29 residents from the University of California, Davis Department of Family and Community Medicine. For all these residents we also had the results of monthly performance evaluations, 2 required OSCE exercises, and the results of 3 American Board of Family Medicine (ABFM) ITEs. Data for each of these measures were abstracted for each resident. The Pearson correlation coefficient was used to assess the presence or lack of correlation between each of these evaluation methods. RESULTS: There is little correlation between various evaluation methods used to assess medical knowledge, and there is also little correlation between various evaluation methods used to assess communication skills. CONCLUSION: The outcome project remains a 'work in progress', with the need for larger studies to assess the value of different assessment measures of resident competence. It is unlikely that DOC will become a useful evaluation tool.

Clinical Competence↗
PubMed2005

"I'm going to die of something anyway": women's perceptions of tamoxifen for breast cancer risk reduction.

OBJECTIVE: To investigate how ethnically diverse women who are eligible for tamoxifen prophylaxis because of their breast cancer risk decide about tamoxifen use for risk reduction. DESIGN: A qualitative intervention pilot study used focus groups to discuss the use of tamoxifen and to identify the concerns of ethnically diverse women about the preventive use of this drug. Focus group discussion involved exploration of the benefits and risks of tamoxifen prophylaxis, presentation of a standardized educational intervention, and focused discussion on attitudes about tamoxifen for prevention. Prominent themes emerged from iterative review of focus group transcripts. RESULTS: Fear of breast cancer was not prominent, and participants were less inclined to take tamoxifen as preventive therapy after receiving information. Decisions were based on participants' understandings of competing risks and benefits. Specifically, participants expressed limited willingness to take medication with potential serious side effects for risk reduction and were unwilling to discontinue hormone replacement therapy. Uneasiness about the reliability of scientific studies surfaced in the focus groups comprised of White and Latina women. African-American women described faith as important to prevention. CONCLUSIONS: Women were wary of taking a drug for a disease they might not develop. Women felt they had options other than tamoxifen to reduce their risk of breast cancer, including early detection, diet, faith, and complementary and alternative therapies.

Aged↗
PubMed2005

Recruitment strategies for minority participation: challenges and cost lessons from the POWER interview.

BACKGROUND: The importance of recruiting and retaining women from diverse populations is well recognized; however, the recruitment process often presents greater challenges at higher costs than initially anticipated. OBJECTIVES: To describe recruitment strategies and costs from a study evaluating women's preferences regarding tamoxifen use for primary prevention of breast cancer. DESIGN: Description and analysis of recruitment strategies, outcomes, and costs for a cross-sectional interview study. SETTING: University hospital and community sites. PARTICIPANTS: 932 racially and ethnically diverse women respondents, of whom 771 completed the screening process (aged 27-87). INTERVENTION: Women were recruited and screened by using the Breast Cancer Risk Assessment Program (BCRA version 1, National Cancer Institute). Eligibility required an estimated five-year breast cancer risk of at least 1.7%. Recruitment goals targeted a high percentage of ethnic minorities. METHODS: Recruitment strategies included direct mail, flyers, newspapers, media advertising, and community outreach. RESULTS: Of the 771 screened women, 341 (44%) met eligibility criteria and 255 (33%) completed interviews (76.9% White, 10.6% Latina, 7.0% Asian, 3.9% African American, 1.6% Native American). Recruitment costs averaged US $113/screened participant. Direct mail and community contact yielded the largest number of participants (312 screened, 205 eligible). Radio advertising provided few participants (one screened, one eligible) at high cost. CONCLUSIONS: Recruiting an ethnically diverse sample presented multiple challenges. We recommend that future studies budget adequately for recruitment time and costs, develop ongoing relationships with key community leaders, evaluate recruitment strategies closely, and report detailed recruitment findings to the research community.

Adult↗
PubMed2004

Development of a diabetes care management curriculum in a family practice residency program.

Improving the quality of care for patients with chronic illness has become a high priority. Implementing training programs in disease management (DM) so the next generation of physicians can manage chronic illness more effectively is challenging. Residency training programs have no specific mandate to implement DM training. Additional barriers at the training facility include: 1) lack of a population-based perspective for service delivery; 2) weak support for self-management of illness; 3) incomplete implementation due to physician resistance or inertia; and 4) few incentives to change practices and behaviors. In order to overcome these barriers, training programs must take the initiative to implement DM training that addresses each of these issues. We report the implementation of a chronic illness management curriculum based on the Improving Chronic Illness Care (ICIC) Model. Features of this process included both patient care and learner objectives. These were: development of a multidisciplinary diabetes DM team; development of a patient registry; development of diabetes teaching clinics in the family practice center (nutrition, general management classes, and one-on-one teaching); development of a group visit model; and training the residents in the elements of the ICIC Model, ie, the community, the health system, self-management support, delivery system design, decision support, and clinical information systems. Barriers to implementing these curricular changes were: the development of a patient registry; buy-in from faculty, residents, clinic leadership, staff, and patients for the chronic care model; the ability to bill for services and maintain clinical productivity; and support from the health system key stakeholders for sustainability. Unique features of each training site will dictate differences in emphasis and structure; however, the core principles of the ICIC Model in enhancing self-management may be generalized to all sites.

California↗
PubMed2002

Reporting number needed to treat and absolute risk reduction in randomized controlled trials.

CONTEXT: Ongoing efforts to improve the quality of reporting for randomized controlled trials (RCTs) include the Consolidated Standards of Reporting Trials (CONSORT) statement. We examined the frequency of explicit reporting of the number needed to treat (NNT) and the absolute risk reduction (ARR) in RCTs. METHODS: Five frequently cited journals were investigated: Annals of Internal Medicine, BMJ, JAMA, The Lancet, and the New England Journal of Medicine. For each journal, 4 years were evaluated: 1989, 1992, 1995, and 1998. All issues of each journal for each year were reviewed manually. Eligible articles were those in which an RCT was conducted on the use of a medication showing a significant treatment effect. Elements abstracted from each eligible article were the condition investigated, event being treated or prevented, intervention, study results, and reporting methods (relative risk reduction, NNT, and ARR). RESULTS: Of 359 eligible articles, NNT was reported in 8 articles. Six of the 8 studies were from 1998. Absolute risk reduction was reported in 18 articles, 10 of which were from 1998. CONCLUSIONS: Despite CONSORT recommendations, few authors expressed their findings in terms of NNT or ARR. Consideration should be given to including these values in reports of RCTs.

Data Interpretation, Statistical↗
PubMed2002

Management of the low-grade abnormal Pap smear: What are women's preferences?

OBJECTIVE: To evaluate preferences among ethnically diverse women for the management of a low-grade abnormal Pap smear result: early colposcopy or observation with repeat Pap smears. STUDY DESIGN: Structured interviews were conducted with 170 women of diverse ethnic backgrounds to assess their preferences. Trained personnel conducted standardized interviews. A standard description of all tests and procedures was read to participants. The participants were presented with scenarios of contrasting management approaches for a hypothetical low-grade abnormal Pap smear result-observation with repeat Pap smear vs. immediate colposcopy. POPULATION: Study participants were recruited from the waiting rooms of 5 family planning clinics in Northern Californiaamprsquos Central Valley. OUTCOMES MEASURED: The primary outcome measures for each scenario were utilities (quantified preferences for specific health states) measured by the Standard Gamble. RESULTS: The range in utilities was large for all scenarios. Mean utilities (SD) for observation: 0.96 ( 0.13) followed by resolution; 0.93 ( 0.17) followed by cryotherapy; 0.91 ( 0.21) followed by cone biopsy. Mean utilities for early colposcopy: 0.93 ( 0.20) followed by resolution; 0.95 ( 0.14) followed by cryotherapy; and 0.92 ( 0.16) followed by cone biopsy. Subject characteristics explained less than 20% of the variance in utilities. Decision analysis gave a slightly higher overall utility for early colposcopy (0.940 vs 0.932 for observation), but was sensitive to small changes in branch utilities. CONCLUSIONS: Womenamprsquos preferences for management of a low-grade abnormal Pap result vary widely. Clinicians should adopt a flexible approach to the management of low-grade abnormal Pap smears to incorporate individual preferences.

Adolescent↗
PubMedDate not supplied

An enhanced obstetrics track for a family practice residency program: results from the first 6 years.

BACKGROUND: Advanced training in obstetrics for family physicians occurs through a variety of methods. The program described has developed an obstetrics track for family practice residents. METHODS: Five residents have completed the 4-year residency program with enhanced obstetric training developed, and the results, in terms of procedural experience and examination scores, have been reviewed. RESULTS: These 5 family physicians performed a similar number of obstetric procedures compared with their Obstetrics and Gynecology resident counterparts, and they performed as well as their family medicine resident counterparts on national in-service examinations. CONCLUSIONS: A 4-year enhanced obstetrics track is an effective means of improving the training of family medicine residents in obstetric procedures while maintaining the other fundamental training and residency review committee requirements for family medicine residents.

Curriculum↗