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Biomedical subjects

William R Lenderking

Publications and source records attributed to William R Lenderking.

8 recordsLinked to original sources
PubMed2006

Responsiveness and minimal important differences for patient reported outcomes.

Patient reported outcomes provide the patient's perspective on the effectiveness of treatment. The draft Food and Drug Administration guidance on patient reported outcomes for labeling and promotional claims raises a number of method and measurement issues that require further clarification, including methods of determining responsiveness and minimal important differences. For clinical trials, instruments need to be based on a clear conceptual framework, have evidence supporting content validity and acceptable psychometric qualities. The measures must also have evidence documenting responsiveness and interpretation guidelines (i.e., minimal important difference) to be most useful as effectiveness endpoints in clinical trials. The recommended approach is to estimate the minimal important difference based on several anchor-based methods, with relevant clinical or patient-based indicators, and to examine various distribution-based estimates (i.e., effect size, standardized response mean, standard error of measurement) as supportive information, and then to triangulate on a single value or small range of values for the MID. Confidence in a specific MID value evolves over time and is confirmed by additional research evidence, including clinical trial experience. The MID may vary by population and context, and no one MID will be valid for all study applications involving a PRO instrument. Responsiveness and MID must be demonstrated and documented for the particular study population, and these measurement characteristics are needed for PRO labeling and promotional claims.

Clinical Trials as Topic↗
PubMed2006

A brief mental health outcomes measure: translation and validation of the Czech version of the Schwartz Outcomes Scale-10.

The Schwartz Outcomes Scale-10 (SOS-10) is a 10-item scale developed to measure the effectiveness of psychiatric treatments. Using standard methodology, we translated the scale into Czech and examined the psychometric properties of the Czech version. 207 in-patients admitted to Prague Psychiatric Center were included in the study. All patients completed the SOS at admission and discharge. The SOS-10 scale was also administered to 170 persons from the general population. Reliability, validity and sensitivity to treatment change of the Czech SOS-10 were analyzed. The Cronbach's alpha coefficient was 0.92. The item-total correlation coefficients varied from 0.56 to 0.82. The SOS-10 correlated well with condition-specific measures including depression (BDI) and anxiety (BAI) and a global self-rated symptom severity scale (CGI). The SOS-10 also had significant correlations with the Health, Basic needs, Relationship, and Leisure time domains of the Czech version of the Subjective Quality of Life Analysis (SQUALA-CZ). The scale discriminated well between patients and controls, with patients scoring significantly lower on all SOS items. The patient sample's admission and discharge scores were significantly different, indicating that the scale is sensitive to treatment changes. We concluded that the Czech SOS-10 is valid with reliability and factor structure similar to the American language version.

Adolescent↗
PubMed2006

Validation of the breast evaluation questionnaire for use with breast surgery patients.

BACKGROUND: : Reliable and valid assessment instruments in aesthetic surgery are a vital factor in assessing patient satisfaction with physical appearance. Appearance and satisfaction assessments are needed to adequately evaluate quality of life related to changes in the female breast across a variety of surgical interventions. The Breast Evaluation Questionnaire was designed to assess satisfaction with breast attributes. METHODS: : The Breast Evaluation Questionnaire is a 55-item assessment that was validated on 1244 women seeking augmentation mammaplasty. RESULTS: : Subscales of the Breast Evaluation Questionnaire include comfort not fully dressed, comfort fully dressed, and satisfaction with breast attributes. The questionnaire has been demonstrated to be valid and reliable for assessing these factors. CONCLUSIONS: : The assessment is easy to administer and interpret and is recommended for assessing outcomes among breast augmentation patients, breast reconstruction patients, mastectomy patients, lumpectomy/breast-sparing surgery patients, breast reduction patients, and patients who have sustained trauma or injury to their breasts.

Adult↗
PubMed2002

Case-crossover study of partner and situational factors for unprotected sex.

OBJECTIVES: To identify situational and partner characteristics associated with unprotected sex among women at risk for HIV infection. METHODS: The most recent unprotected and protected sexual encounters were compared using a case-crossover design among 1,647 women enrolled in a prospective cohort study conducted in six U.S. cities. Information collected via audio computer-assisted self-interview included detailed situational and partner characteristics for participants' most recent sexual encounters, with and without condom use. Paired odds ratios (ORs) and 95% confidence intervals were calculated for situational or partner characteristics that may differ between unprotected and protected sexual encounters, using conditional logistic regression. RESULTS: In the adjusted analysis, partner age of older than 40 years (OR = 2.42), partner type (OR = 2.45 for a "steady" partner), partner use of alcohol (OR = 1.67) and drugs within 2 hours (OR = 1.42) of the sexual encounter, time since the encounters (OR = 0.41, 0.33, and 0.19), and exchange of sex for money or drugs (OR = 0.68) remained significantly associated with women's most recent unprotected sexual encounter. CONCLUSIONS: Considerations related to partner and relationship characteristics should provide information for the development of interventions for women.

Adult↗
PubMed2002

Outcomes and costs of acute treatment of traumatic brain injury.

BACKGROUND: Although there are nearly a quarter of a million hospitalizations for traumatic brain injury (TBI) in the United States each year, data on the outcomes and costs of TBI treatment in the acute-care setting are limited. METHODS: Using a large, geographically diverse, multihospital database, we examined inpatient records for persons aged 16 years or older who were hospitalized for TBI between January 1, 1997, and June 30, 1999. Patients were stratified by TBI severity using an adaptation of the Abbreviated Injury Scale for administrative data (ICD/AIS), as follows: 2 = "moderate"; 3 = "serious"; 4 = "severe"; and 5 = "critical." Patient characteristics, patterns of treatment, and outcomes and costs were examined by injury severity and mechanism of injury. RESULTS: Of 8,717 study subjects identified, 12.5% had moderate, 44.8% had serious, 29.6% had severe, and 13.2% had critical TBI. Falls were the most common reported cause of injury (40.8%), followed by motor vehicle crashes (39.3%), blows to the head (11.3%), and gunshot wounds (2.4%). Average length of stay in hospital ranged from 6.7 days for moderate TBI to 17.5 days for critical TBI. The overall rate of death in hospital was relatively low among patients with moderate (1.3%), serious (5.7%), and severe (8.7%) TBIs, but much higher among the most critically injured patients (52.0%). Costs of hospitalization averaged 8,189 dollars for moderate, 14,603 dollars for serious, 16,788 dollars for severe, and 33,537 dollars for critical TBI. Costs also varied by injury type, averaging 20,084 dollars for gunshot wounds, 20,522 dollars for motor vehicle crashes, 15,860 dollars for falls, and 19,949 dollars for blows to the head. CONCLUSION: The economic burden of TBI in the acute-care setting is substantial; treatment outcomes and costs vary considerably by TBI severity and mechanism of injury.

Adolescent↗
PubMedDate not supplied

The clinical characteristics and impact of laryngopharyngeal reflux disease on health-related quality of life.

BACKGROUND AND OBJECTIVES: Although it is accepted that reflux of stomach acid causes gastroesophageal reflux disease (GERD), it is less well understood that it also contributes to the clinical signs and symptoms of laryngitis in the form of laryngopharyngeal reflux (LPR). Study objectives were to identify what is known about the impact of LPR on health-related quality of life (HRQL) compared with the impact of GERD on HRQL and to assess whether currently available HRQL instruments adequately measure this impact or if a new disease-specific instrument should be recommended. METHODS: The authors combined a systematic literature review with prospective patient evaluation via focus groups. The review, using MEDLINE, focused on clinical characteristics and HRQL measurement and impact. Focus groups involving a total of 30 patients with LPR provided input on clinical manifestations of the disease and its HRQL impact. RESULTS: Information gleaned from the literature indicates that less than 40% of patients presenting with symptoms of laryngitis directly attributable to reflux also report experiencing the classic symptoms of heartburn and acid regurgitation associated with GERD. Reflux laryngitis is thus a distinct clinical entity from GERD and may have a unique impact on HRQL. Although multiple instruments are available to assess the impact of GERD on HRQL, no specific instruments are available for LPR. Focus group discussions identified voice problems, chronic cough, throat clearing, and swallowing difficulties to be key concerns of patients with LPR. These manifestations negatively impact HRQL as described by the focus group participants, notably in role functioning, physical well-being, and emotional well-being. CONCLUSIONS: A disease-specific instrument to assess the impact of LPR on HRQL would contribute to clinical care and the evaluation of new therapies. This instrument would ideally be sensitive to the variety of LPR's symptomatic presentations.

Focus Groups↗