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Biomedical subjects

Mary-Margaret Chren

Publications and source records attributed to Mary-Margaret Chren.

At least 19 recordsLinked to original sources
PubMed2006

Narrative review: the promotion of gabapentin: an analysis of internal industry documents.

BACKGROUND: Internal documents from the pharmaceutical industry provide a unique window for understanding the structure and methods of pharmaceutical promotion. Such documents have become available through litigation concerning the promotion of gabapentin (Neurontin, Pfizer, Inc., New York, New York) for off-label uses. PURPOSE: To describe how gabapentin was promoted, focusing on the use of medical education, research, and publication. DATA SOURCES: Court documents available to the public from United States ex. rel David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company, mostly from 1994-1998. DATA EXTRACTION: All documents were reviewed by 1 author, with selected review by coauthors. Marketing strategies and tactics were identified by using an iterative process of review, discussion, and re-review of selected documents. DATA SYNTHESIS: The promotion of gabapentin was a comprehensive and multifaceted process. Advisory boards, consultants meetings, and accredited continuing medical education events organized by third-party vendors were used to deliver promotional messages. These tactics were augmented by the recruitment of local champions and engagement of thought leaders, who could be used to communicate favorable messages about gabapentin to their physician colleagues. Research and scholarship were also used for marketing by encouraging "key customers" to participate in research, using a large study to advance promotional themes and build market share, paying medical communication companies to develop and publish articles about gabapentin for the medical literature, and planning to suppress unfavorable study results. LIMITATIONS: Most available documents were submitted by the plaintiff and may not represent a complete picture of marketing practices. CONCLUSION: Activities traditionally considered independent of promotional intent, including continuing medical education and research, were extensively used to promote gabapentin. New strategies are needed to ensure a clear separation between scientific and commercial activity.

Advisory Committees↗
PubMed2006

Testing and reducing skindex-29 using Rasch analysis: Skindex-17.

The Skindex is a well-studied dermatology-specific health-related quality of life (HRQOL) instrument. The objective of this study was to test Skindex-29 using Rasch analysis and, if necessary, to refine it so that it would fit this item response theory based model. The Skindex-29 of 454 Italian dermatological patients was subjected to Rasch analysis to investigate threshold order, differential item functioning (DIF), and item and overall fit to the model. The Skindex-29 did not fit the Rasch model (P<0.001). The 5-point scoring system was re-grouped into three categories and demonstrated logical response order for all but one item. Rasch analyses of a combined emotion and social functioning subscale of Skindex-29 resulted in a 12-item psychosocial subscale. Five of seven items were retained in a symptoms subscale. Both subscales fitted the model (P=0.32 and 0.13, respectively) without significant individual item misfit or DIF (P>0.05). Classical psychometric properties such as response distribution, item-rest correlation, item complexity, and internal consistency of the two subscales of Skindex-17 were at least adequate. The Skindex-17 is a Rasch reduced version of Skindex-29, with two independent scores that can be used in the measurement of HRQOL in dermatological patients.

Adult↗
PubMed2005

The price of pruritus: sleep disturbance and cosleeping in atopic dermatitis.

BACKGROUND: Atopic dermatitis is a common skin disorder that most often begins in infancy. Sleep disturbances in children with atopic dermatitis are likely due to itching and scratching and not only impact the afflicted child but may also affect the entire family. Sleep characteristics in young children with atopic dermatitis and their families have not been thoroughly investigated. OBJECTIVE: To evaluate sleep disturbance and cosleeping in young children with atopic dermatitis and evaluate the association between sleep characteristics and features of the disease. DESIGN AND METHODS: Parents of 300 children ranging in age from birth to 6 years with atopic dermatitis responded to 4 questions about sleep characteristics of their child and family. Analyses determined the prevalence of reported sleep disturbance and cosleeping, and their association with features of the patients and disease severity. RESULTS: Sleep disturbance attributed to atopic dermatitis was common; most parents (> 60%) reported that the dermatitis affected how well they or their child slept. Cosleeping because of the skin condition was reported by 30% of families, and most of these parents (66%) were bothered by the cosleeping. Sleep disturbance and cosleeping were directly associated with severity of atopic dermatitis and with the degree to which parents reported that the atopic dermatitis affected the child and family's happiness. CONCLUSIONS: Sleep disturbances were more common in children with atopic dermatitis than have been reported in children overall. These results demonstrate important sequelae of a very common childhood condition that warrant further investigation and the development of intervention strategies.

Adult↗
PubMed2005

Evaluating clinical rating scales for evidence-based dermatology: some basic concepts.

Evidence-based dermatology has necessitated the development of rating scales that measure multidimensional and abstract constructs, such as quality of life. This article discusses some basic psychometric concepts, such as reliability, validity, standardization, and measurement precision, which need to be considered when choosing a clinical rating instrument. Also discussed is the impact of these parameters on increasing the statistical power of a clinical trial.

Dermatology↗
PubMed2005

Development of the Childhood Atopic Dermatitis Impact Scale: initial validation of a quality-of-life measure for young children with atopic dermatitis and their families.

To measure the effects of atopic dermatitis (AD) on the quality of life of affected young children and their families, we developed a prototype 62-item instrument, the Childhood Atopic Dermatitis Impact Scale (CADIS). The prototype CADIS was developed from a comprehensive conceptual framework based on data from parents and clinicians. The instrument had eight subscales (four each for child and parent): physical health, emotional health, physical functioning, and social functioning. The goal of this work was to test the validity of and to refine the prototype of CADIS. Two hundred seventy parents of children under the age of 6 y with AD responded to the instrument. Content validity was demonstrated by expert and parent reviews of the drafted and refined instrument, and by analyzing parents' responses to open-ended questions about their children's skin disease. Construct validity was assessed in exploratory factor analyses which supported a refinement in the conceptual framework to consist of two dimensions with five domains: child dimensions (symptoms and activity limitation/behavior), and parent dimensions (family/social function, sleep, and emotions). Seventeen items were eliminated, yielding a 45-item refined version of CADIS (score 0-180) with evidence of content and construct validity and suggested use in clinical research.

Adolescent↗
PubMed2004

Impact of renal insufficiency on mortality in advanced lower extremity peripheral arterial disease.

Renal insufficiency predicts mortality among patients who are treated for myocardial infarction and congestive heart failure, but its clinical significance in advanced peripheral arterial disease has not been evaluated. A national cohort of 5787 male veterans who received an initial diagnosis of rest pain, ischemic ulceration, or gangrene between January 1, 2000, and September 30, 2002, and had at least one serum creatinine measurement within 3 mo before diagnosis were identified. Sixty-two percent (n = 3561) of cohort members had normal or mildly reduced renal function (GFR > or =60 ml/min per 1.73 m(2)), 30% (n = 1742) had moderate renal insufficiency (GFR 30 to 59 ml/min per 1.73 m(2)), and 8% (n = 484) had severe renal insufficiency or renal failure (GFR <30 ml/min per 1.73 m(2)) but were not on dialysis. The percentages of patients who presented with gangrene or ischemic ulceration rather than rest pain increased with declining renal function (70, 77, and 87%; P < 0.001), as did 1-yr mortality risk (17, 27, and 44%; P < 0.001). After adjustment for demographic and clinical characteristics, patients with a GFR of 30 to 59 ml/min per 1.73 m(2) (odds ratio, 1.32; 95% confidence interval, 1.13 to 1.53) and <30 ml/min per 1.73 m(2) (odds ratio, 2.97; 95% confidence interval, 2.39 to 3.69) had a significantly increased odds of death within 1 yr of cohort entry. Both moderate and severe renal insufficiency are associated with an increased odds of death in patients with critical limb ischemia. Death rates were particularly high among those with a GFR <30 ml/min per 1.73 m(2). This finding may be partly explained by their more frequent presentation with ischemic ulceration or gangrene rather than rest pain.

Aged↗
PubMed2004

Variation in care for nonmelanoma skin cancer in a private practice and a veterans affairs clinic.

BACKGROUND: Nonmelanoma skin cancer is the most common malignancy. Multiple therapies prevent recurrence but vary widely in cost. The most common therapies are local destruction, excision, and Mohs surgery (histologically guided tumor removal). Clinical variables that may affect treatment choices can be identified, but little is known about how clinicians choose among therapies. OBJECTIVE: The objective of this study was to learn if variations exist in the treatment of nonmelanoma skin cancer in different practice settings. RESEARCH DESIGN: Prospective cohort study. SUBJECTS: Subjects consisted of consecutive patients with nonmelanoma skin cancer at a university-affiliated private dermatology practice and the dermatology clinic at the nearby affiliated Veterans Affairs (VA) medical center. DATA: We studied data from medical records and patient surveys. RESULTS: Overall, 1777 nonrecurrent nonmelanoma skin cancers were diagnosed in 1375 patients. Compared with the VA site, patients at the private site were younger, more likely to be female, and less likely to be poor, and their tumors were smaller and less likely to be on visible areas of the body. Treatments varied between the 2 sites (P <0.001). The proportions of tumors treated at the private and VA sites, respectively, were 23% and 19% for destruction, 25% and 48% for excision, and 37% and 25% for Mohs surgery. In multiple clinical subgroups, Mohs surgery was more likely to be performed at the private site than at the VA. Moreover, in multivariable models controlling for clinical features that may have affected treatment choice, tumors at the private site were more likely than tumors at the VA to be treated with Mohs surgery (odds ratio, 2.39; 95% confidence interval, 1.54-3.70). CONCLUSIONS: Care for nonmelanoma skin cancer varied at 2 academic practice sites that are near each other and that share some clinician staff. These findings raise questions not only about overuse or underuse of procedures at the 2 sites, but also about systematic differences in patient preferences and/or physician incentives in prepaid and fee-for-service settings.

Age Factors↗
PubMed2004

Variability in nomenclature used for nevi with architectural disorder and cytologic atypia (microscopically dysplastic nevi) by dermatologists and dermatopathologists.

BACKGROUND: Although a nevus with the microscopic features of a "dysplastic nevus" is commonly seen, the nomenclature used to describe such a lesion has been thought to be inconsistent. A 1992 National Institutes of Health (NIH) Consensus Conference sought to unify nomenclature and suggested that the term "nevus with architectural disorder" be used along with a comment on melanocytic atypia. METHODS: We performed a cross-sectional mail survey to determine preferred terminology as well as the level of adherence to the NIH-recommended nomenclature. All 856 active members of the American Society of Dermatopathology (ASDP) and 1100 (13.0%) of the 8471 active members of the American Academy of Dermatology (AAD) were surveyed. RESULTS: Five hundred and thirty-three ASDP members and 483 AAD members who fulfilled eligibility criteria completed the questionnaire. The term "dysplastic nevus" was favored by the largest number of responders (favored by 39.1% of ASDP members and 62.3% of AAD members), while the 1992 NIH Consensus Conference-recommended terminology was the second most popular term (25.3% of ASDP and 15.1% of AAD members). Dermatopathologists (OR = 1.9, p = 0.0001) and those who had dual training in dermatology and dermatopathology (OR = 1.6, p = 0.02 for ASDP members; OR = 2.3, p = 0.02 for AAD members) were more likely to adhere to the 1992 NIH Consensus Conference nomenclature. CONCLUSIONS: Despite attempts to unify nomenclature for microscopically dysplastic nevi through the NIH Consensus Conference, wide variation in terminology persists.

Consensus Statements as Topic↗
PubMed2004

Nonsteroidal anti-inflammatory drug use in the prevention and treatment of squamous cell carcinoma.

BACKGROUND: Nonsteroidal anti-inflammatory drugs are widely reported to inhibit carcinogenesis. OBJECTIVE: The objective was to review the literature on nonsteroidal anti-inflammatory drugs in the prevention and treatment of cancer as it pertains to cutaneous squamous cell carcinoma. METHODS: We searched MEDLINE and performed a review of all published data on nonsteroidal anti-inflammatory drugs and cutaneous oncogenesis. RESULTS: In vitro and animal data strongly suggest a role for cyclooxygenase-2 in the formation of actinic keratoses and squamous cell carcinomas. Further observational studies and clinical trials are needed to assess their putative role in chemoprevention. CONCLUSIONS: Nonsteroidal anti-inflammatory drugs have activity against squamous cell carcinomas in vitro and in animal models, as well as in precursor lesions of squamous cell carcinomas. Human trials using selective cyclooxygenase-2 inhibitors are currently in progress and should offer exciting information regarding the chemopreventative function of nonsteroidal anti-inflammatory drugs.

Animals↗
PubMed2004

Effects of atopic dermatitis on young American children and their families.

OBJECTIVE: The psychologic, physical, and social impact of atopic dermatitis is complex and varies among children of different ages, and the effects of atopic dermatitis on the quality of life of very young American children and their families are not well understood. This study was conducted to document these effects of atopic dermatitis on young children and their families. METHODS: Directed focus sessions were performed with parents of 26 young children with atopic dermatitis and 6 expert clinicians. Specific mentions of the ways in which atopic dermatitis affected the children and parents were reviewed, rank ordered, and categorized according to similarity in content. The categories were examined to determine the domains represented, and the domains were used to compose a conceptual framework of all of the ways that atopic dermatitis affects children and their families. RESULTS: Parents and experts mentioned a total of 181 specific quality-of-life effects. A conceptual framework, developed from the 181 effects, contains the domains of physical health, emotional health, physical functioning, and social functioning; each domain includes effects on both the child and the parents. CONCLUSIONS: Atopic dermatitis greatly affects the quality of life of afflicted children and their families. The comprehensive conceptual framework summarizes the ways in which atopic dermatitis affects the quality of life in young American children. This conceptual framework forms the basis from which quality-of-life instruments can be developed.

Child, Preschool↗
PubMed2003

Cognitive screening predicts magnitude of functional recovery from admission to 3 months after discharge in hospitalized elders.

BACKGROUND: Many older adults lose functional ability during the course of acute illness and fail to recover function. We sought to determine whether performance on a cognitive screen at the time of hospital admission predicted the magnitude of functional recovery after hospitalization. METHODS: We studied 2557 patients from two teaching hospitals to examine the association between level of impaired performance on a cognitive status screen and maintenance and recovery of functioning from admission through 90 days after discharge. On admission, 14% had mildly impaired cognitive performance with three or four errors on the Short Portable Mental Status Questionnaire; 28% had moderate to severely impaired cognitive performance with five or more errors on the cognitive status screen or inability to complete the screen and a diagnosis of dementia. RESULTS: Performance on a brief cognitive screen on admission was strongly related to subsequent change in function. Among patients who needed help performing one or more activities of daily living at the time of admission, 23% of patients with moderate to severely impaired cognitive performance, 49% of patients with mildly impaired cognitive performance, and 67% of patients with little to no impairment in cognitive performance recovered ability to independently execute an additional activity of daily living by discharge (p <.001). Similar relationships were seen for change in instrumental activities of daily living and mobility. In multivariate repeated measures analyses of basic and instrumental activities of daily living and mobility on admission, discharge, and 30 and 90 days after discharge, patients with mildly impaired cognitive performance on admission showed less improvement than patients who did not have impaired cognitive performance, but more than those with moderate to severely impaired cognitive performance. The pattern of results did not change when patients with any signs of delirium were excluded. Patients with impaired cognitive performance were more likely to be admitted to a nursing home for the first time by 90 days after discharge. The odds ratios were 2.8 (95% confidence interval = 1.8-4.5) for patients with mildly impaired cognitive performance and 6.7 (95% confidence interval = 4.5-9.8) for patients with moderate to severely impaired cognitive performance. CONCLUSION: Cognitive screening at hospital admission can be used to stratify patients according to the magnitude of expected functional recovery after an acute illness that required hospitalization.

APACHE↗
PubMed2002

Skin-related quality of life in HIV-infected patients on highly active antiretroviral therapy.

BACKGROUND: The overall health status and survival of HIV-infected patients has changed with the advent of highly active antiretroviral therapy (HAART). With this improved survival, there is a greater urgency to study quality-of-life issues. OBJECTIVE: Our objectives were to measure skin-related quality of life in a cohort of HIV-infected patients and to determine whether the use of highly active antiretroviral therapy is associated with improved skin-related quality of life. METHODS: We assembled a retrospective cohort of patients who were seen in our HIV-Dermatology Clinic at San Francisco General Hospital in June, July, or August of 1996. Eligible subjects were contacted by mail and asked (1) to complete a questionnaire (Skindex) and (2) to have a skin exam. Information on medication use and laboratory parameters was also collected. RESULTS: Of 107 eligible patients, 76 (71%) responded to the questionnaire; 60 patients were examined. Many patients had multiple skin conditions. For most diagnoses (except warts and onychomycosis), there were no consistent differences in Skindex scores of HIV-infected patients compared with scores of patients not known to be infected with HIV. Patients on HAART for longer duration had significantly lower Skindex scores (improved skin-related quality of life) compared with those on HAART for a shorter duration. CONCLUSION: HAART is associated with improved quality of life with regard to HIV-associated skin diseases.

Adult↗
PubMed2002

Scalpdex: a quality-of-life instrument for scalp dermatitis.

OBJECTIVE: To develop a scalp dermatitis-specific quality-of-life instrument. METHODS: Based on the results of directed focus sessions with 8 patients with scalp psoriasis or seborrheic dermatitis, we conceptualized 3 major constructs that explain the way scalp dermatoses affect patient quality of life: symptoms, functioning, and emotions. We constructed a 23-item instrument, Scalpdex, and tested its reliability, responsiveness, and validity. RESULTS: Fifty-two dermatology patients completed the study. We demonstrated construct validity by confirming that the factors derived by principal axes factor analyses with orthogonal rotation correlated to our hypothesized scales (r = 0.76-0.84) and that differences in symptom, functioning, and emotion scores differed among the varying levels of self-reported scalp severity more than would be expected by chance (P<.05 by analysis of variance). The instrument demonstrated reliability with internal consistency (Cronbach alpha, 0.62-0.80) and reproducibility (intraclass correlation coefficient, 0.90-0.97). The quality-of-life scores changed in the expected direction in our test for responsiveness (P<or=.05, by paired t test for functioning and emotion for those who improved). We ascertained the discriminant capability of Scalpdex compared with a dermatological generic quality-of-life tool, Skindex, by demonstrating superior responsiveness (P<or=.005 by paired t test in functioning and emotion) and improved overall sensitivity in individual items. CONCLUSIONS: Scalpdex is, to our knowledge, the first quality-of-life instrument specifically for patients with scalp dermatitis that is reliable, valid, and responsive. Clinicians can use the instrument to determine which aspect of the disease most bothers the patient and to evaluate quality of life as one variable of responsiveness to the therapeutic intervention.

Adult↗
PubMed2002

Use of a cane for ambulation: marker and mitigator of impairment in older people who report no difficulty walking.

OBJECTIVES: To measure disability, patients are often asked whether they have difficulty performing daily tasks. However, recent work suggests that functional problems may be detected earlier by inquiring about modifications in the way tasks are performed. We sought to describe the characteristics of older people who deny difficulty walking but nevertheless have modified the manner in which they walk, by use of a cane. We also tested the hypothesis that, among older people who deny difficulty walking, those using a cane have more mobility problems and are at greater risk for future mobility problems than those not using a cane. DESIGN: Longitudinal survey study, with measures at baseline and 2-year follow-up. SETTING: Population-based survey of urban older people. PARTICIPANTS: One thousand two hundred fifty-one community-dwelling older persons without severe cognitive impairment who reported no difficulty walking at baseline. MEASUREMENTS: Self-reported health, activities of daily living (ADL), and mobility status. RESULTS: Among older people who denied difficulty walking, those who used a cane at baseline (7 of subjects) were older and more likely to have taken medication for a heart condition or arthritis, to have an ADL deficit, and to have been hospitalized in the past year. They were less likely to have walked for pleasure in the past month and more likely to report difficulty crossing roads or intersections. Moreover, those using a cane at baseline were more likely to develop new mobility problems at follow-up. For example, 15 of those who used a cane at baseline reported new difficulty walking at follow-up, compared with 2 of those who did not use a cane. CONCLUSION: Older people who deny difficulty walking but who use a cane are at greater risk than those who do not use a cane for the development of difficulty walking and other new mobility problems. Asking patients about task modification rather than difficulty alone may be a more sensitive way to detect early or mild functional problems.

Activities of Daily Living↗