Decision making at the fringe of evidence: take what you can get.
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Cardiovascular Diseases↗
Biomedical subjects
Nananda F Col
Publications and source records attributed to Nananda F Col.
Healthy women with a family history of breast cancer: impact of a tailored genetic counseling intervention on risk perception, knowledge, and menopausal therapy decision making.
BACKGROUND: Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy (HT), alternative medications, or no treatment. This complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. The authors determined the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision making in a group of healthy women who had a first-degree relative with breast cancer. METHODS: Forty-eight cancer-free menopausal women age > or =40 years who had at least one first-degree relative with breast cancer were randomized to a genetic counseling intervention or control. Intervention participants were given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data. Knowledge, risk perception, and medication usage were measured at baseline, 1 month, and 6 months. RESULTS: Knowledge was higher in the intervention group at both follow-up time points postintervention. Perceived risk for developing breast cancer was significantly lower and more accurate in the intervention group at 1 and 6 months postintervention than at baseline, as was perceived risk of developing heart disease. Although the counseling intervention did affect both knowledge and risk perception, overall, both groups were reluctant to take any form of menopausal therapy. CONCLUSIONS: A personalized risk assessment and genetic counseling intervention improves patient knowledge and risk perception; however, it is unclear that the intervention influenced menopausal treatment decisions.
Adult↗
The impact of risk status, preexisting morbidity, and polypharmacy on treatment decisions concerning menopausal symptoms.
Because each menopausal treatment has a unique benefit-risk profile, deciding whether menopausal hormone therapy (HT) or another menopausal treatment is appropriate for an individual requires assessing the risks and benefits of each treatment as well as determining the patient's risk factors, comorbidities, and current medications. Simple summary metrics for assessing net treatment effects on multiple outcomes, such as the Women's Health Initiative's (WHI) global index, are not necessarily generalizable beyond the study population in which they were derived. However, trial evidence can be translated to individual decisions by transforming relative risks into absolute risks. The validity of generalizing relative risks found in clinical trials to groups with differing baseline risks depends on the homogeneity of relative risks across various risk strata. Subgroup analyses from the major clinical studies of HT found its relative risks for cardiovascular disease, hip fracture, breast cancer, colorectal cancer, and ovarian cancer to be relatively uniform across strata defined by age, race/ethnicity, antecedent risk status, or prior disease. The number of significant subgroup findings in these studies tended to match the number expected by chance alone. However, data are limited for many subgroups, especially those with comorbidities. Strata defined by the concurrent use of drugs that can interact with HT are not expected to be homogeneous, yet data on drug interactions are limited. More data are needed about the effects of menopausal treatments in diverse populations, and more attention is needed to translate this evidence into clinical practice and to develop tools to support informed decision making.
Estrogen Replacement Therapy↗
Menopausal hormone therapy after breast cancer: a meta-analysis and critical appraisal of the evidence.
INTRODUCTION: Menopausal hormone therapy (HT) is typically withheld from breast cancer survivors because of concerns about risk for recurrence. Our objectives were to estimate the effects of HT on recurrence in breast cancer survivors and to examine the reliability of these estimates. METHODS: In a systematic review of the literature we identified all reports of HT use in breast cancer survivors that included comparison groups. Study design features that might affect selection of participants, detection of recurrence, and manuscript publication were assessed. The relative risks for breast cancer recurrence associated with HT were combined with random effects models. RESULTS: Two randomized and eight observational studies included 1,316 breast cancer survivors who used HT and 2,839 nonusers. In the observational studies, HT users were younger and more commonly node negative; only two reported balanced restaging for HT and control groups. Randomized trials suggest that HT increased the risk for recurrence (relative risk 3.41, 95% confidence interval 1.59-7.33), whereas observational studies suggest that HT decreased this risk (relative risk 0.64, 95% confidence interval 0.50-0.82). CONCLUSION: Results from observational studies of HT conducted in breast cancer survivors are discrepant with results from randomized trials. Observational studies of HT use in breast cancer survivors have design limitations that cannot be controlled for using standard statistical methods. Therefore, the randomized clinical trial data provide the only reliable estimates of the effect of HT use on recurrence risks in breast cancer survivors.
Age Factors↗
Commentary--surgical decisions after breast cancer: can patients be too involved in decision making?
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Breast Neoplasms↗
Subclinical thyroid disease: scientific review and guidelines for diagnosis and management.
CONTEXT: Patients with serum thyroid-stimulating hormone (TSH) levels outside the reference range and levels of free thyroxine (FT4) and triiodothyronine (T3) within the reference range are common in clinical practice. The necessity for further evaluation, possible treatment, and the urgency of treatment have not been clearly established. OBJECTIVES: To define subclinical thyroid disease, review its epidemiology, recommend an appropriate evaluation, explore the risks and benefits of treatment and consequences of nontreatment, and determine whether population-based screening is warranted. DATA SOURCES: MEDLINE, EMBASE, Biosis, the Agency for Healthcare Research and Quality, National Guideline Clearing House, the Cochrane Database of Systematic Reviews and Controlled Trials Register, and several National Health Services (UK) databases were searched for articles on subclinical thyroid disease published between 1995 and 2002. Articles published before 1995 were recommended by expert consultants. STUDY SELECTION AND DATA EXTRACTION: A total of 195 English-language or translated papers were reviewed. Editorials, individual case studies, studies enrolling fewer than 10 patients, and nonsystematic reviews were excluded. Information related to authorship, year of publication, number of subjects, study design, and results were extracted and formed the basis for an evidence report, consisting of tables and summaries of each subject area. DATA SYNTHESIS: The strength of the evidence that untreated subclinical thyroid disease is associated with clinical symptoms and adverse clinical outcomes was assessed and recommendations for clinical practice developed. Data relating the progression of subclinical to overt hypothyroidism were rated as good, but data relating treatment to prevention of progression were inadequate to determine a treatment benefit. Data relating a serum TSH level higher than 10 mIU/L to elevations in serum cholesterol were rated as fair but data relating to benefits of treatment were rated as insufficient. All other associations of symptoms and benefit of treatment were rated as insufficient or absent. Data relating a serum TSH concentration lower than 0.1 mIU/L to the presence of atrial fibrillation and progression to overt hyperthyroidism were rated as good, but no data supported treatment to prevent these outcomes. Data relating restoration of the TSH level to within the reference range with improvements in bone mineral density were rated as fair. Data addressing all other associations of subclinical hyperthyroid disease and adverse clinical outcomes or treatment benefits were rated as insufficient or absent. Subclinical hypothyroid disease in pregnancy is a special case and aggressive case finding and treatment in pregnant women can be justified. CONCLUSIONS: Data supporting associations of subclinical thyroid disease with symptoms or adverse clinical outcomes or benefits of treatment are few. The consequences of subclinical thyroid disease (serum TSH 0.1-0.45 mIU/L or 4.5-10.0 mIU/L) are minimal and we recommend against routine treatment of patients with TSH levels in these ranges. There is insufficient evidence to support population-based screening. Aggressive case finding is appropriate in pregnant women, women older than 60 years, and others at high risk for thyroid dysfunction.
Humans↗
Subclinical thyroid disease: clinical applications.
Subclinical hypothyroidism and hyperthyroidism are diagnoses based on laboratory evaluation with few if any clinical signs or symptoms. Subclinical hypothyroidism is defined as an elevation in serum thyroid-stimulating hormone (TSH) above the upper limit of the reference range (0.45-4.5 mIU/L) with normal serum FT4 concentration; subclinical hyperthyroidism is defined as a decrease in serum TSH below the reference range with normal serum FT4 and T3 concentrations. Though these conditions represent the earliest stages of thyroid dysfunction, the benefits of detecting and treating subclinical thyroid disease are not well established. Most persons found to have subclinical thyroid disease will have TSH values between 0.1 and 0.45 mIU/L or between 4.5 and 10 mIU/L, for which the benefits of treatment are not clearly established; treatment may be beneficial in individuals with serum TSH lower than 0.1 mIU/L or higher than 10 mIU/L. This article illustrates approaches to managing patients with subclinical hypothyroidism and hyperthyroidism through 5 case scenarios that apply the principles of evidence-based medicine. Because of the substantial uncertainty concerning the consequences of untreated subclinical hypothyroidism and hyperthyroidism, as well as the benefit of initiating treatment, patient preferences are important in deciding on management of subclinical disease.
Adult↗
The discrepancy between observational studies and randomized trials of menopausal hormone therapy: did expectations shape experience?
Differences between observational and randomized studies of the effects of menopausal hormone therapy (HT) on coronary heart disease (CHD) have been attributed to the fact that women who choose to use HT tend to be healthier than those who do not. Although this bias should affect all clinical outcomes with modifiable risk factors, estimates for stroke and pulmonary embolism were unaffected. The authors sought possible explanations for this isolated discrepancy in CHD findings. Unlike the randomized Women's Health Initiative (WHI) trial, the observational Nurses' Health Study (NHS) did not try to detect silent myocardial infarctions. Many women present with atypical ischemic symptoms. Hormone therapy users who believe that HT reduces CHD risks might not interpret ischemic symptoms as related to CHD, might not seek medical attention, and might present differently to their physicians, all of which could lead to more unrecognized myocardial infarctions among HT users in the NHS. In addition, persons completing death certificates and NHS physicians interpreting death certificates were not blinded to the use of HT. If persons assigning cause of death knew the patient had used HT and believed that HT prevented CHD, they might have been more likely to assign a condition other than CHD as the cause of death. If HT users were 20% less likely to have their infarctions recognized and their deaths attributed to CHD, a true increase in CHD due to HT use would appear to be a reduction in CHD. Combining these reporting biases with socioeconomic differences between users and nonusers could explain discrepancies. Beliefs held by patients, clinicians, and investigators might have affected the ascertainment of CHD outcomes in observational studies.
Bias↗
Meta-analysis of vascular and neoplastic events associated with tamoxifen.
OBJECTIVE: Tamoxifen reduces the risk of developing breast cancer but also affects the risks of certain vascular and neoplastic events. Our purpose was to estimate the effects of tamoxifen on potentially life-threatening vascular and neoplastic outcomes. DESIGN: Random effects meta-analysis of published randomized controlled trials. PATIENTS: Participants in all trials in which a treatment arm that included tamoxifen was compared to a similar control arm. Breast cancer risk reduction and treatment trials were included. INTERVENTIONS: Tamoxifen at variable dose and duration. MEASUREMENTS AND MAIN RESULTS: Thirty-two trials (52,929 patients) reported one or more outcomes of interest. Tamoxifen was associated with significantly increased risks of endometrial cancer (relative risk [RR] 2.70; 95% CI, 1.94 to 3.75), gastrointestinal cancers (RR 1.31; 95% CI, 1.01 to 1.69), strokes (RR 1.49; 95% CI, 1.16 to 1.90), and pulmonary emboli (RR 1.88; 95% CI, 1.77 to 3.01). Tamoxifen had no effect on secondary malignancies other than endometrial and gastrointestinal cancers (RR 0.96; 95% CI, 0.81 to 1.13). In contrast, tamoxifen significantly decreased myocardial infarction deaths (RR 0.62; 95% CI, 0.41 to 0.93) and was associated with a statistically insignificant decrease in myocardial infarction incidence (RR 0.90; 95% CI, 0.66 to 1.23). Postmenopausal women had greater risk increases for neoplastic outcomes. CONCLUSIONS: This meta-analysis of randomized trials found tamoxifen use to be significantly associated with several neoplastic and vascular outcomes. Consideration of tamoxifen use requires balance of potential benefits and risks.
Aged↗
Estimating hip fracture morbidity, mortality and costs.
OBJECTIVES: To estimate lifetime morbidity, mortality, and costs from hip fracture incorporating the effect of deficits in activities of daily living. DESIGN: Markov computer cohort simulation considering short- and long-term outcomes attributable to hip fractures. Data estimates were based on published literature, and costs were based primarily on Medicare reimbursement rates. SETTING: Postacute hospital facility. PARTICIPANTS: Eighty-year-old community dwellers with hip fractures. MEASUREMENTS: Life expectancy, nursing facility days, and costs. RESULTS: Hip fracture reduced life expectancy by 1.8 years or 25% compared with an age- and sex-matched general population. About 17% of remaining life was spent in a nursing facility. The lifetime attributable cost of hip fracture was $81,300, of which nearly half (44%) related to nursing facility expenses. The development of deficits in ADLs after hip fracture resulted in substantial morbidity, mortality, and costs. CONCLUSION: Hip fractures result in significant mortality, morbidity, and costs. The estimated lifetime cost for all hip fractures in the United States in 1997 likely exceeded $20 billion. These results emphasize the importance of current and future interventions to decrease the incidence of hip fracture.
Activities of Daily Living↗
Estrogen deficiency symptom management in breast cancer survivors in the changing context of menopausal hormone therapy.
Vasomotor symptoms associated with menopause or cancer therapies represent an increasingly common problem for breast cancer survivors given the increasing use of ovarian suppression in premenopausal women and aromatase inhibitors in postmenopausal women. Although estrogen and/or progestin effectively reduce vasomotor symptoms, a recent Women's Health Initiative (WHI) randomized trial identified an unfavorable risk/benefit balance on life-threatening diseases, including increased breast cancer, for combined estrogen plus progestin use in otherwise healthy postmenopausal women. As a result, use of menopausal hormone therapy (MHT) for chronic disease risk reduction in any population cannot be supported. In addition, the safety of estrogen and/or progestin regarding risk of recurrence or new cancer development in breast cancer survivors has not been demonstrated. For vasomotor symptoms in this population, neuroendocrine agents, including selective seratonin reuptake inhibitors (SSRIs) or gabapentin, are reasonable choices with substantial impact on hot flashes and moderate toxicity profiles. When rigorously evaluated, most other nonhormonal pharmacologic and herbal interventions have been found to have either modest or no efficacy and/or limiting toxicity. In breast cancer survivors even local vulvar/vaginal symptoms are best treated by nonhormone products since drug absorption with systemic estrogen-like effects has been reported. Estrogen/progestin use in breast cancer survivors should be considered only for women with severe vasomotor symptoms refractory to other approaches after extensive informed decision-making including review of current Food and Drug Administration labeling concerns with use limited to the lowest dose and shortest duration possible.
Breast Neoplasms↗
Impact of a personalized decision support aid on menopausal women - results from a randomized controlled trial.
To improve menopausal counseling, we developed a computer-generated personalized menopause decision support aid (DSA) and measured its impact in a randomized, controlled trial. Results suggest that this DSA may help women make informed decisions about menopausal therapy, change their risk perceptions, and motivate behavioral change.
Decision Support Techniques↗
Use of the Internet for seeking health care information among young adults.
Little is known about what types of health information young adults seek online. A survey was conducted at a diverse community college to assess what health topics students seek online, and analyzed on the basis of smoking status. The most popular topic was found to be health/nutrition. Tobacco/smoking information was the least sought after topic even though 22% of the study group identified themselves as smokers.
Adult↗
Short-term menopausal hormone therapy for symptom relief: an updated decision model.
BACKGROUND: Hormone therapy (HT) provides the most effective relief of menopausal symptoms. This therapy is associated with a decreased risk of osteoporosis and colorectal cancer but increased risks of cardiovascular disease (CVD), venous thrombosis, and breast cancer. Our objective was to identify which women should benefit from short-term HT by exploring the trade-off between symptom relief and risks of inducing disease. METHODS: A Markov model simulates the effect of short-term (2 years) estrogen and progestin HT on life expectancy and quality-adjusted life expectancy (QALE) among 50-year-old menopausal women with intact uteri, using findings from the Women's Health Initiative. Quality-of-life (QOL) utility scores were derived from the literature. We assumed HT-affected QOL only during perimenopause, when it reduced symptoms by 80%. RESULTS: Among asymptomatic women, short-term HT was associated with net losses in life expectancy and QALE of 1 to 3 months, depending on CVD risk. Women with mild or severe menopausal symptoms gained 3 to 4 months or 7 to 8 months of QALE, respectively. Among women at low risk for CVD, HT extended QALE if menopausal symptoms lowered QOL by as little as 4%. Among women at elevated CVD risk, HT extended QALE only if symptoms lowered QOL by at least 12%. CONCLUSIONS: Hormone therapy is associated with losses in survival but gains in QALE for women with menopausal symptoms. Women expected to benefit from short-term HT can be identified by the severity of their menopausal symptoms and CVD risk.
Black or African American↗
Challenges in translating research into practice.
This paper provides a high-level summary of the literature concerning barriers to disseminating research findings about medication use into clinical practice. Various interventions targeting patients or providers are reviewed. Conceptual models for understanding the multiple barriers to dissemination are critically reviewed, and an alternative framework is proposed that considers the perspective of both providers and patients and the characteristics of treatments. Areas of further research are suggested.
Diffusion of Innovation↗
The pitfalls of non-evidence-based guidelines.
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Decision Making↗
Survival impact of tamoxifen use for breast cancer risk reduction: projections from a patient-specific Markov model.
The authors estimate tamoxifen's impact on life expectancy among healthy women. A Markov model compared the effects of 5 years of tamoxifen on survival among 50-year-old postmenopausal women. Scenarios were explored using alternative assumptions with regard to tamoxifen's long-term effects on breast and endometrial cancer. Postmenopausal women without a uterus had substantial life expectancy gains from tamoxifen (1 to 4 months), whereas women with a uterus had such gains only if they were at a very high breast cancer risk. If tamoxifen's impact on endometrial cancer persists after treatment is discontinued, women at high risk for endometrial cancer have life expectancy losses from tamoxifen unless they are at a very high risk for breast cancer. The authors conclude that tamoxifen use among postmenopausal women is associated with substantial life expectancy gains. However, this benefit is modulated in women at increased endometrial cancer risk and depends on assumptions concerning tamoxifen's lingering effects on breast and endometrial cancer.
Anticarcinogenic Agents↗
The use of gene tests to detect hereditary predisposition to chronic disease: is cost-effectiveness analysis relevant?
Screening for genetic susceptibility provides new opportunities for preventing common diseases, but whether such screening will result in substantial costs or savings is unclear. Cost-effectiveness analyses (CEAs) provide a theoretical framework for guiding clinical decisions about genetic tests. However, CEAs have been largely irrelevant in informing policy, clinical decisions, or patient demand concerning these genetic tests. Genetic tests have often proceeded directly from development and preliminary validation into clinical practice, with little understanding of their clinical, economic, and psychosocial implications. Using screening for BRCA mutations as an example, the accuracy of the tests and the effectiveness of many interventions among those who screen positive remain in question. CEAs do not seem to have played an important role in identifying whom to offer genetic testing nor how to manage those found to carry the gene marker. Credible CEAs are needed to provide guidance about screening decisions.
Breast Neoplasms↗