Rachel Hess

Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations

PurposeWhile clinical care is frequently directed at making patients “feel better,” patients’ reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User’s Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User’s Guide.MethodsUsing the literature, an ISOQOL team outlined considerations for using PROs in clinical practice; options for designing the intervention; and strengths, weaknesses, and resource requirements associated with each option.ResultsImplementing routine PRO assessment involves a number of methodological and practical decisions, including (1) identifying the goals for collecting PROs in clinical practice, (2) selecting the patients, setting, and timing of assessments, (3) determining which questionnaire(s) to use, (4) choosing a mode for administering and scoring the questionnaire, (5) designing processes for reporting results, (6) identifying aids to facilitate score interpretation, (7) developing strategies for responding to issues identified by the questionnaires, and (8) evaluating the impact of the PRO intervention on the practice.ConclusionsIntegrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User’s Guide will be updated periodically.

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.

Hot Flashes and Subclinical Cardiovascular Disease Findings From the Study of Women’s Health Across the Nation Heart Study

Background— Although evidence suggests adverse vascular changes among women with hot flashes, it is unknown whether hot flashes are associated with subclinical cardiovascular disease. The aim of this study was to examine relations between menopausal hot flashes and indices of subclinical cardiovascular disease. We hypothesized that women with hot flashes would show reduced flow-mediated dilation and greater coronary artery and aortic calcification compared with women without hot flashes. Methods and Results— The Study of Women’s Health Across the Nation Heart Study (2001 to 2003) is an ancillary study to the Study of Women’s Health Across the Nation, a community-based cohort study. Participants were 492 women (35% black, 65% white) 45 to 58 years of age who were free of clinical cardiovascular disease and had a uterus and at least 1 ovary. Measures included a brachial artery ultrasound to assess flow-mediated dilation, electron beam tomography to assess coronary artery and aortic calcification, reported hot flashes (any/none, previous 2 weeks), and a blood sample for measurement of estradiol concentrations. Cross-sectional associations were evaluated with linear regression and partial proportional odds models. Hot flashes were associated with significantly lower flow-mediated dilation (&bgr;=−1.01; SE, 0.41; P=0.01) and greater coronary artery (odds ratio, 1.48; 95% confidence interval, 1.04 to 2.12) and aortic (odds ratio, 1.55; 95% confidence interval, 1.10 to 2.19) calcification in age- and race-adjusted models. Significant associations between hot flashes and flow-mediated dilation (&bgr;=−0.97; SE, 0.44; P=0.03) and aortic calcification (odds ratio, 1.63; 95% confidence interval, 1.07 to 2.49) remained in models adjusted for cardiovascular disease risk factors and estradiol. Conclusions— Women with hot flashes had reduced flow-mediated dilation and greater aortic calcification. Hot flashes may mark adverse underlying vascular changes among midlife women.

Duration of Menopausal Vasomotor Symptoms Over the Menopause Transition

IMPORTANCE The expected duration of menopausal vasomotor symptoms (VMS) is important to women making decisions about possible treatments. OBJECTIVES To determine total duration of frequent VMS (≥ 6 days in the previous 2 weeks) (hereafter total VMS duration) during the menopausal transition, to quantify how long frequent VMS persist after the final menstrual period (FMP) (hereafter post-FMP persistence), and to identify risk factors for longer total VMS duration and longer post-FMP persistence. DESIGN, SETTING, AND PARTICIPANTS The Study of Womens Health Across the Nation (SWAN) is a multiracial/multiethnic observational study of the menopausal transition among 3302 women enrolled at 7 US sites. From February 1996 through April 2013, women completed a median of 13 visits. Analyses included 1449 women with frequent VMS. MAIN OUTCOMES AND MEASURES Total VMS duration (in years) (hot flashes or night sweats) and post-FMP persistence (in years) into postmenopause. RESULTS The median total VMS duration was 7.4 years. Among 881 women who experienced an observable FMP, the median post-FMP persistence was 4.5 years. Women who were premenopausal or early perimenopausal when they first reported frequent VMS had the longest total VMS duration (median, >11.8 years) and post-FMP persistence (median, 9.4 years). Women who were postmenopausal at the onset of VMS had the shortest total VMS duration (median, 3.4 years). Compared with women of other racial/ethnic groups, African American women reported the longest total VMS duration (median, 10.1 years). Additional factors related to longer duration of VMS (total VMS duration or post-FMP persistence) were younger age, lower educational level, greater perceived stress and symptom sensitivity, and higher depressive symptoms and anxiety at first report of VMS. CONCLUSIONS AND RELEVANCE Frequent VMS lasted more than 7 years during the menopausal transition for more than half of the women and persisted for 4.5 years after the FMP. Individual characteristics (eg, being premenopausal and having greater negative affective factors when first experiencing VMS) were related to longer-lasting VMS. Health care professionals should counsel women to expect that frequent VMS could last more than 7 years, and they may last longer for African American women.

Obesity in Older Adults: A Systematic Review of the Evidence for Diagnosis and Treatment

Objective: Although obesity is increasing in older U.S. adults, treatment is controversial in this age group. We sought to examine evidence concerning obesitys health‐related risks, diagnostic methods, and treatment outcomes in older individuals.

Change in health-related quality of life over the menopausal transition in a multiethnic cohort of middle-aged women: Study of Women's Health Across the Nation

Objective: The aim of this study was to examine changes in health-related quality of life (HRQL) during the menopausal transition, controlling for chronological aging, symptoms, and other covariates. Methods: This was a prospective, longitudinal study of women aged 42 to 52 years at baseline recruited at seven US sites (N = 3,302) in the multiethnic Study of Womens Health Across the Nation. Women eligible for the cohort had an intact uterus, had at least one ovary, were not currently using exogenous hormones, were either premenopausal or early perimenopausal, and were self-identified as one of the studys designated racial/ethnic groups. Data from the baseline interview and six annual follow-up visits are reported. HRQL was assessed with five subscales from the Medical Outcomes Study Short-Form Health Survey, with reduced functioning defined as being in the lowest 25% on a subscale. Covariates included symptoms, medical conditions, sociodemographics variables, physical activity, and psychological factors. Results: With adjustment for baseline age, chronological aging, and relevant covariates, the odds of reduced role-physical functioning were significantly greater at late perimenopause (odds ratio, 1.46; 95% CI, 1.08-1.99) and postmenopause (odds ratio, 1.49; 95% CI, 1.09-2.04) compared with premenopause. Menopause status was unrelated to bodily pain, vitality, role-emotional, or social functioning. Hormone therapy users were more likely to report reduced functioning. Other variables significantly related to HRQL across all domains included vasomotor symptoms, urine leakage, poor sleep, arthritis, depressed mood, perceived stress, and stressful life events. Conclusions: The menopausal transition showed little impact on HRQL when adjusted for symptoms, medical conditions, and stress.

Using the Internet to translate an evidence-based lifestyle intervention into practice.

Despite evidence-based recommendations for addressing obesity in the clinical setting, lifestyle interventions are lacking in practice. The objective of this study was to translate an evidence-based lifestyle program into the clinical setting by adapting it for delivery via the Internet. We adapted the Diabetes Prevention Programs lifestyle curriculum to an online format, comprising 16 weekly and 8 monthly lessons, and conducted a before-and-after pilot study of program implementation and feasibility. The program incorporates behavioral tools such as e-mail prompts for online self-monitoring of diet, physical activity, and weight, and automated weekly progress reports. Electronic counseling provides further support. Physician referral, automated progress reports, and as-needed communication with lifestyle coaches integrate the intervention with clinical care. We enrolled 50 patients from a large academic general internal practice into a pilot program between November 16, 2006 and February 11, 2007. Patients with a body mass index (BMI) =25 kg/m2, at least one weight-related cardiovascular risk factor, and Internet access were eligible if referring physicians felt the lifestyle goals were safe and medically appropriate. Participants were primarily female (76%), with an average age of 51.94 (standard deviation [SD] 10.82), and BMI of 36.43 (SD 6.78). At 12 months of enrollment, 50% of participants had logged in within 30 days. On average, completers (n = 45) lost 4.79 (SD 8.55) kg. Systolic blood pressure dropped 7.33 (SD 11.36) mm Hg, and diastolic blood pressure changed minimally (+0.44 mm Hg; SD 9.27). An Internet-based lifestyle intervention may overcome significant barriers to preventive counseling and facilitate the incorporation of evidence-based lifestyle interventions into primary care.

Patient Web Portals to Improve Diabetes Outcomes: A Systematic Review

Patient web portals (PWPs), defined as the integration of electronic medical records and patient health records, have been related to enhanced patient outcomes. A literature review was conducted to characterize the design and evaluation of PWPs to improve health care processes and outcomes in diabetes. A summary of 26 articles revealed the positive impact PWPs have on patient outcomes, patient-provider communication, disease management, and access to and patient satisfaction with health care. Innovative and useful approaches included the evaluation of specific components of the PWPs, assessing the impact of PWPs on mediators of health behaviors, such as patient distress, identification of barriers to use, and patient willingness to pay for access. Future research should focus on relevant processes that mediate patient and provider use, impact on health care utilization, and a patient-centered approach to the design and integration of educational opportunities afforded through PWPs.

Living With Diabetes Normalizing the Process of Managing Diabetes

Purpose The purpose of this qualitative study was to explore perceptions of people with diabetes about their experience of living with and managing their diabetes. Methods This study was part of a larger study of patients with diabetes who used a novel computer portal system for access to information about diabetes and to their health care providers for enhanced communication. The research method used for this portion of the study was grounded theory methodology, a particular kind of qualitative research method. Results A central theme generated from the data was “normalizing an identity as a person with diabetes.” The participants described themselves as diabetic; they took on an identity in which having diabetes was central. They struggled with how to become “a person with diabetes” rather than a “diabetic person.” Conclusions For people who are diagnosed with diabetes, there is a struggle to become a person with diabetes rather than a diabetic person and to manage the lifestyle changes that are mandated by this role/identity. One way of dealing or coping with this new identity is to begin to “normalize” these lifestyle changes—to view them as healthy living for all people, those with and without diabetes. This will then have implications for interventions—encouraging healthy lifestyles among people with diabetes rather than emphasizing that people with diabetes are “different from” the general population.

Interest in the Use of Computerized Patient Portals: Role of the Provider–Patient Relationship

BackgroundBioinformatics experts are developing interactive patient portals to help those living with diabetes and other chronic diseases to better manage their conditions. However, little is known about what influences patients’ desires to use this technology.ObjectiveTo discern the impact of the provider–patient relationship on interest in using a web-based patient portal.DesignQualitative analysis of focus groups.ParticipantsTen focus groups involving 39 patients (range 2–7) recruited from four primary care practices.ApproachA qualitative approach was used, which involved reading transcribed texts until a consensus was reached on data interpretation. An intercoder reliability kappa score (0.89) was determined by comparing the provider–patient relationship talk selected by the two coders. A conceptual framework was developed, which involved the development and refinement of a codebook and the application of it to the transcripts.ResultsInterest in the portal was linked to dissatisfaction with the provider–patient relationship, including dissatisfaction with provider communication/responsiveness, the inability to obtain medical information, and logistical problems with the office. Disinterest in the portal was linked to satisfaction with the provider–patient relationship, including provider communication/responsiveness, difficulty in using the portal, and fear of losing relationships and e-mail contact with the provider. No patient identified encrypted e-mail communication through the portal as an advantage.ConclusionsPromoting the use of computerized portals requires patient-based adaptations. These should include ease of use, direct provider e-mail, and reassurances that access and interpersonal relationships will not be lost. Education is needed about privacy concerns regarding traditional e-mail communication.