To assess patient responses to radical prostatectomy and its effects. A national sample was taken... more To assess patient responses to radical prostatectomy and its effects. A national sample was taken of 1072 Medicare patients who underwent radical prostatectomy for prostate cancer (1988 through 1990) by mail, telephone, and personal interviews. The effects of the surgery and its complications on these patients' lives were studied through: (1) patient ratings of the extent to which sexual and urinary dysfunctions were "problems" in their lives; (2) two general measures of quality of life, the Mental Health Index and the General Health Index; (3) patient reports of how they felt about the results of treatment and whether they would choose surgery again. On average, dripping urine, particularly to the point where subjects were wearing pads, had a more significant effect on patients than loss of sexual function; incontinence had significant adverse effects on the measures of quality of life and self-reported results of surgery. Overall, postsurgical patients scored comparatively high on the quality of life measures (similar to a cohort of patients with benigh prostatic hyperplasia who had undergone transurethral resection of the prostate), reported feeling positive about the results (81%), and would choose surgical treatment again (89%). Nonetheless, there was variability in patient response to the effects of surgery. The results demonstrate the ability of many Medicare patients to adapt to adverse outcomes, such as loss of sexual function and incontinence. They also provide evidence of the variability of individual patients' responses to surgical results and reinforce the importance of individualized decision making for patients facing a decision about radical prostatectomy for prostate cancer.
Researchers are very concerned that parents are not good reporters about the experiences of their... more Researchers are very concerned that parents are not good reporters about the experiences of their adolescent children. More and more, people who want to get accurate information about the experiences of adolescents feel it is important to interview teenagers ...
Scientifically validated (accurate), and reproducible (precise) methods of assessing the frequenc... more Scientifically validated (accurate), and reproducible (precise) methods of assessing the frequency and severity of patient symptoms are becoming more widely used in medicine. Such a symptom index has been developed for patients with benign prostatic hyperplasia, and may find use in clinical practice and research. The criteria for developing and validating such indexes are presented, using the new benign prostatic hyperplasia symptom index as an example. The same approach can be applied to many other disease entities in urology that demand a quantitation of the illness experience from the perspective of the patients.
To assess the effect of nonsurgical management of leiomyomas, abnormal uterine bleeding, and chro... more To assess the effect of nonsurgical management of leiomyomas, abnormal uterine bleeding, and chronic pelvic pain on symptoms and quality of life. We performed a prospective cohort study of women receiving nonsurgical management (n = 380) or hysterectomy (n = 311) for leiomyomas, abnormal uterine bleeding, or chronic pelvic pain. Patients recruited from the practices of 63 physicians throughout Maine were interviewed at the outset of treatment and 3, 6, and 12 months later. The principal outcome measures were frequency and severity of physical and psychological symptoms, and quality of life as measured by validated indices of mental and general health and physical activity. Medical therapy for abnormal bleeding and chronic pelvic pain produced significant improvements in symptoms and quality of life. However, almost one-quarter of patients initially treated nonsurgically subsequently underwent hysterectomy; of patients continuing nonsurgical therapy, 25% with abnormal bleeding and 50% with chronic pelvic pain reported substantial levels of symptoms after 1 year. There were no significant changes in symptoms and quality of life in patients treated nonsurgically for leiomyomas. New problems including tiredness, hot flashes, weight gain, and depression developed in 10% or less of women who did not report these symptoms preoperatively. A logistic regression analysis controlling for age, reproductive history, and severity of symptoms showed that hysterectomy was the factor most highly correlated with a positive outcome at 1 year for all three conditions. Many women with leiomyomas, abnormal bleeding, and chronic pelvic pain report improved symptoms over time with nonsurgical management. Hysterectomy remains an important alternative when conservative treatment fails.
To assess the effect of hysterectomy for nonmalignant conditions on symptoms and quality of life ... more To assess the effect of hysterectomy for nonmalignant conditions on symptoms and quality of life and to identify adverse effects 1 year after surgery. The Maine Women's Health Study was a prospective cohort study of 418 women ages 25-50 years undergoing hysterectomy for any nonmalignant condition. Patients recruited from the practices of 63 physicians performing hysterectomy throughout Maine were interviewed at the time of surgery and 3, 6, and 12 months later. Clinical and hospitalization data were obtained from physician reports and from a statewide hospital discharge data base. The primary outcomes of interest were symptom relief, changes in quality of life, and the development of new symptoms or problems during the year following surgery. The most frequent indications for hysterectomy were leiomyomas (35%), abnormal bleeding (22%), and chronic pelvic pain (18%). For these indications, hysterectomy resulted in marked improvements in a range of symptoms, including pelvic pain, urinary symptoms, fatigue, psychological symptoms, and sexual dysfunction. Significant improvements in scores for indices of mental health, general health, and activity were evident at 6 months and sustained at 1 year. New problems after hysterectomy (measured in those free of the symptom preoperatively) included hot flashes (13%), weight gain (12%), depression (8%), and lack of interest in sex (7%). Hysterectomy is highly effective for relief of symptoms associated with common nonmalignant gynecologic conditions. Symptom relief following hysterectomy is associated with a marked improvement in quality of life. New problems are reported after hysterectomy by a limited number of women.
This study examines the correspondence between retrospective and prospective assessments of treat... more This study examines the correspondence between retrospective and prospective assessments of treatment outcomes among female patients treated for gynecologic symptoms (n = 800) and male patients having surgery for benign prostatic hyperplasia (n = 434). The overall health and symptom status of patients in both samples was assessed at enrollment and again 3 months after treatment; at the 3-month follow-up, patients also were asked to compare retrospectively their current health and how they were feeling with their condition before treatment. Findings indicate that prospective and retrospective measures of change do not yield the same results. Retrospective assessments consistently produce higher estimates of the benefits of treatment, although that pattern was clearer for overall health status than for measures of symptoms. Patients' posttreatment health and symptom status contributes as much to retrospective assessments of change as does prospectively measured change, although the retrospective assessments of female patients whose gynecologic symptoms were medically managed were more strongly related to prospective change than those of hysterectomy patients or prostate surgery patients. Overall, we conclude that these alternative measurement strategies yield divergent assessments of change, depending on the type of treatment a patient receives and, to some extent, what is being measured.
This study was designed to detect any effect of order when modules on disease-specific and overal... more This study was designed to detect any effect of order when modules on disease-specific and overall health status are combined in an outcomes research questionnaire. Men with symptomatic benign prostatic hyperplasia (BPH) were prospectively enrolled in a clinical trial of an educational intervention in Group Health Cooperative of Puget Sound, a prepaid group practice. Within the trial, 392 consecutive men were randomized to one of two versions of a baseline questionnaire. One had a 38-item module on BPH-specific health status first, followed by a 30-item module on overall health status; the other had the modules in reverse order. Scores were compared for three BPH-specific scales and eight scales measuring overall health. Data were collected in the form of self-administered questionnaires. Comparing the groups assigned the two versions of the questionnaire, no significant differences in scores on any of the health status scales were found. In this dataset, we could find no evidence of an order effect when modules on BPH-specific and overall health status were combined in different sequences.
JAMA The Journal of the American Medical Association
Multiple treatment options are available for men with prostate cancer, but therapeutic recommenda... more Multiple treatment options are available for men with prostate cancer, but therapeutic recommendations may differ depending on the type of specialist they consult. To define and contrast the distribution of management recommendations by urologists and radiation oncologists for a spectrum of men with prostate cancer. Mail survey sent in 1998 to a random sample of physicians in the United States, who were listed as urologists (response rate 64%, n=504) and radiation oncologists (response rate 76%, n=559) in the American Medical Association Registry of Physicians and practicing at least 20 hours per week. Questionnaire addressing beliefs and practices regarding prostate cancer management. Forty-three percent of radiation oncologists vs 16% of urologists would recommend routine prostate-specific antigen testing for men aged 80 years and older. For men with moderately differentiated, clinically localized cancers, and a more than 10-year life expectancy, 93% of urologists chose radical prostatectomy as the preferred treatment option, while 72% of radiation oncologists believed surgery and external beam radiotherapy were equivalent treatments. For most tumor grades and prostate-specific antigen levels, both specialty groups were significantly more likely to recommend the treatment in their specialty than the other treatment. Both groups reported giving patients similar estimates of the risks of complications due to surgery and radiation. Neither group favored watchful waiting in their treatment management except for a subset of men with life expectancies of less than 10 years and cancers with very favorable prognoses (Gleason score of 3 or 4 and prostate-specific antigen level </=5 ng/mL). Based on this study, while urologists and radiation oncologists do agree on a variety of issues regarding detection and treatment of prostate cancer, specialists overwhelmingly recommend the therapy that they themselves deliver. JAMA. 2000;283:3217-3222
The main goal of the Consumer Assessments of Health Plans Study (CAHPS) is to develop an integrat... more The main goal of the Consumer Assessments of Health Plans Study (CAHPS) is to develop an integrated set of tested, standardized surveys to obtain meaningful information from health plan enrollees about their experiences. The CAHPS project benefits from the complementary strengths of psychometric and cognitive testing. The CAHPS team conducted 150 cognitive interviews across three organizations in different geographic locations using multiple interview methods with different consumer populations. This article explains how cognitive testing was used in the CAHPS survey development process and shares the main findings from the cognitive interviews. A modified report format is more appropriate when asking about specific aspects of plan enrollees' experiences, whereas a rating format is useful for asking about overall assessments. Specifying a longer reference period is preferable to asking about the most recent visit when capturing experiences with care, because some respondents get frustrated when they cannot include experiences other than the most recent visit. Explicit screeners and tailored inapplicable response categories are beneficial in mail questionnaires, so people know that they should not answer questions about which they have no relevant experience. Cognitive testing was integral in the development and refinement of the CAHPS instrument. The cognitive testing findings contributed to an improved instrument that should capture consumers' health care and plan experiences with less response error than one not subjected to such testing. The cognitive testing process and findings can be useful to other researchers with similar survey development goals.
An interactive videodisc (using a single screen Macintosh II, HyperCard driven, Level III, CAV in... more An interactive videodisc (using a single screen Macintosh II, HyperCard driven, Level III, CAV interactive videodisc) has been designed, produced, and pretested to permit patients with benign prostatic hyperplasia (BPH), facing a choice of surgery or watchful waiting, to take an active role in decision-making. The Informed Patient Decision-Making Procedure (IPDP) educates the patient about the benefits and harms of two treatment choices: prostatectomy and watchful waiting for BPH, by presenting patient-specific data derived from an analysis of medical outcomes. and video testimonials from patients with good and unfortunate outcomes of the therapeutic options. The IPDP standardizes the information provided to the patients, provides informed consent, gathers follow-up outcomes research data, and permits automated assessment of patient preferences and utilities. In this demonstration, the development of the IPDP is discussed, the videodisc program is presented, and lessons learned in creating medical videodiscs are shared.
In preparation for an outcomes study of benign prostatic hyperplasia (BPH), two measures of disea... more In preparation for an outcomes study of benign prostatic hyperplasia (BPH), two measures of disease-specific health status were developed to supplement a symptom score and overall health status measures. The symptom problem index (SPI) captures how troublesome patients find their urinary symptoms. The BPH impact index (BII) measures how much their urinary problems affect various domains of health. A prospective revalidation of the refined instruments (N = 108 BPH patients and 50 controls) documented that both indices had good internal consistency (Cronbach's alpha = 0.88 and 0.79, respectively) and test-retest (r = 0.88 for both) reliabilities, correlated strongly with symptom scores (r = 0.86 and 0.77), and discriminated between BPH and control subjects (receiver-operating characteristic areas = 0.87 and 0.85, respectively). These indices were nearly as responsive as symptom scores in 50 men actively treated for BPH, and much more responsive than a non-disease-specific General Health Index (GHI), a Mental Health Index (MHI), and an Activity Index (AI). Finally, these measures capture most of the health status significance of BPH symptoms. In linear regression models constructed to predict scores on the GHI, MHI, and AI, symptom scores added little explanatory power to the SPI and, particularly, to the BII. These measures help clarify how BPH affects overall health status and function. Such measures have an important role to play in studies of the outcomes of treatment for BPH, and probably for other conditions that interfere with health status and function.
To assess patient responses to radical prostatectomy and its effects. A national sample was taken... more To assess patient responses to radical prostatectomy and its effects. A national sample was taken of 1072 Medicare patients who underwent radical prostatectomy for prostate cancer (1988 through 1990) by mail, telephone, and personal interviews. The effects of the surgery and its complications on these patients' lives were studied through: (1) patient ratings of the extent to which sexual and urinary dysfunctions were "problems" in their lives; (2) two general measures of quality of life, the Mental Health Index and the General Health Index; (3) patient reports of how they felt about the results of treatment and whether they would choose surgery again. On average, dripping urine, particularly to the point where subjects were wearing pads, had a more significant effect on patients than loss of sexual function; incontinence had significant adverse effects on the measures of quality of life and self-reported results of surgery. Overall, postsurgical patients scored comparatively high on the quality of life measures (similar to a cohort of patients with benigh prostatic hyperplasia who had undergone transurethral resection of the prostate), reported feeling positive about the results (81%), and would choose surgical treatment again (89%). Nonetheless, there was variability in patient response to the effects of surgery. The results demonstrate the ability of many Medicare patients to adapt to adverse outcomes, such as loss of sexual function and incontinence. They also provide evidence of the variability of individual patients' responses to surgical results and reinforce the importance of individualized decision making for patients facing a decision about radical prostatectomy for prostate cancer.
Researchers are very concerned that parents are not good reporters about the experiences of their... more Researchers are very concerned that parents are not good reporters about the experiences of their adolescent children. More and more, people who want to get accurate information about the experiences of adolescents feel it is important to interview teenagers ...
Scientifically validated (accurate), and reproducible (precise) methods of assessing the frequenc... more Scientifically validated (accurate), and reproducible (precise) methods of assessing the frequency and severity of patient symptoms are becoming more widely used in medicine. Such a symptom index has been developed for patients with benign prostatic hyperplasia, and may find use in clinical practice and research. The criteria for developing and validating such indexes are presented, using the new benign prostatic hyperplasia symptom index as an example. The same approach can be applied to many other disease entities in urology that demand a quantitation of the illness experience from the perspective of the patients.
To assess the effect of nonsurgical management of leiomyomas, abnormal uterine bleeding, and chro... more To assess the effect of nonsurgical management of leiomyomas, abnormal uterine bleeding, and chronic pelvic pain on symptoms and quality of life. We performed a prospective cohort study of women receiving nonsurgical management (n = 380) or hysterectomy (n = 311) for leiomyomas, abnormal uterine bleeding, or chronic pelvic pain. Patients recruited from the practices of 63 physicians throughout Maine were interviewed at the outset of treatment and 3, 6, and 12 months later. The principal outcome measures were frequency and severity of physical and psychological symptoms, and quality of life as measured by validated indices of mental and general health and physical activity. Medical therapy for abnormal bleeding and chronic pelvic pain produced significant improvements in symptoms and quality of life. However, almost one-quarter of patients initially treated nonsurgically subsequently underwent hysterectomy; of patients continuing nonsurgical therapy, 25% with abnormal bleeding and 50% with chronic pelvic pain reported substantial levels of symptoms after 1 year. There were no significant changes in symptoms and quality of life in patients treated nonsurgically for leiomyomas. New problems including tiredness, hot flashes, weight gain, and depression developed in 10% or less of women who did not report these symptoms preoperatively. A logistic regression analysis controlling for age, reproductive history, and severity of symptoms showed that hysterectomy was the factor most highly correlated with a positive outcome at 1 year for all three conditions. Many women with leiomyomas, abnormal bleeding, and chronic pelvic pain report improved symptoms over time with nonsurgical management. Hysterectomy remains an important alternative when conservative treatment fails.
To assess the effect of hysterectomy for nonmalignant conditions on symptoms and quality of life ... more To assess the effect of hysterectomy for nonmalignant conditions on symptoms and quality of life and to identify adverse effects 1 year after surgery. The Maine Women's Health Study was a prospective cohort study of 418 women ages 25-50 years undergoing hysterectomy for any nonmalignant condition. Patients recruited from the practices of 63 physicians performing hysterectomy throughout Maine were interviewed at the time of surgery and 3, 6, and 12 months later. Clinical and hospitalization data were obtained from physician reports and from a statewide hospital discharge data base. The primary outcomes of interest were symptom relief, changes in quality of life, and the development of new symptoms or problems during the year following surgery. The most frequent indications for hysterectomy were leiomyomas (35%), abnormal bleeding (22%), and chronic pelvic pain (18%). For these indications, hysterectomy resulted in marked improvements in a range of symptoms, including pelvic pain, urinary symptoms, fatigue, psychological symptoms, and sexual dysfunction. Significant improvements in scores for indices of mental health, general health, and activity were evident at 6 months and sustained at 1 year. New problems after hysterectomy (measured in those free of the symptom preoperatively) included hot flashes (13%), weight gain (12%), depression (8%), and lack of interest in sex (7%). Hysterectomy is highly effective for relief of symptoms associated with common nonmalignant gynecologic conditions. Symptom relief following hysterectomy is associated with a marked improvement in quality of life. New problems are reported after hysterectomy by a limited number of women.
This study examines the correspondence between retrospective and prospective assessments of treat... more This study examines the correspondence between retrospective and prospective assessments of treatment outcomes among female patients treated for gynecologic symptoms (n = 800) and male patients having surgery for benign prostatic hyperplasia (n = 434). The overall health and symptom status of patients in both samples was assessed at enrollment and again 3 months after treatment; at the 3-month follow-up, patients also were asked to compare retrospectively their current health and how they were feeling with their condition before treatment. Findings indicate that prospective and retrospective measures of change do not yield the same results. Retrospective assessments consistently produce higher estimates of the benefits of treatment, although that pattern was clearer for overall health status than for measures of symptoms. Patients' posttreatment health and symptom status contributes as much to retrospective assessments of change as does prospectively measured change, although the retrospective assessments of female patients whose gynecologic symptoms were medically managed were more strongly related to prospective change than those of hysterectomy patients or prostate surgery patients. Overall, we conclude that these alternative measurement strategies yield divergent assessments of change, depending on the type of treatment a patient receives and, to some extent, what is being measured.
This study was designed to detect any effect of order when modules on disease-specific and overal... more This study was designed to detect any effect of order when modules on disease-specific and overall health status are combined in an outcomes research questionnaire. Men with symptomatic benign prostatic hyperplasia (BPH) were prospectively enrolled in a clinical trial of an educational intervention in Group Health Cooperative of Puget Sound, a prepaid group practice. Within the trial, 392 consecutive men were randomized to one of two versions of a baseline questionnaire. One had a 38-item module on BPH-specific health status first, followed by a 30-item module on overall health status; the other had the modules in reverse order. Scores were compared for three BPH-specific scales and eight scales measuring overall health. Data were collected in the form of self-administered questionnaires. Comparing the groups assigned the two versions of the questionnaire, no significant differences in scores on any of the health status scales were found. In this dataset, we could find no evidence of an order effect when modules on BPH-specific and overall health status were combined in different sequences.
JAMA The Journal of the American Medical Association
Multiple treatment options are available for men with prostate cancer, but therapeutic recommenda... more Multiple treatment options are available for men with prostate cancer, but therapeutic recommendations may differ depending on the type of specialist they consult. To define and contrast the distribution of management recommendations by urologists and radiation oncologists for a spectrum of men with prostate cancer. Mail survey sent in 1998 to a random sample of physicians in the United States, who were listed as urologists (response rate 64%, n=504) and radiation oncologists (response rate 76%, n=559) in the American Medical Association Registry of Physicians and practicing at least 20 hours per week. Questionnaire addressing beliefs and practices regarding prostate cancer management. Forty-three percent of radiation oncologists vs 16% of urologists would recommend routine prostate-specific antigen testing for men aged 80 years and older. For men with moderately differentiated, clinically localized cancers, and a more than 10-year life expectancy, 93% of urologists chose radical prostatectomy as the preferred treatment option, while 72% of radiation oncologists believed surgery and external beam radiotherapy were equivalent treatments. For most tumor grades and prostate-specific antigen levels, both specialty groups were significantly more likely to recommend the treatment in their specialty than the other treatment. Both groups reported giving patients similar estimates of the risks of complications due to surgery and radiation. Neither group favored watchful waiting in their treatment management except for a subset of men with life expectancies of less than 10 years and cancers with very favorable prognoses (Gleason score of 3 or 4 and prostate-specific antigen level </=5 ng/mL). Based on this study, while urologists and radiation oncologists do agree on a variety of issues regarding detection and treatment of prostate cancer, specialists overwhelmingly recommend the therapy that they themselves deliver. JAMA. 2000;283:3217-3222
The main goal of the Consumer Assessments of Health Plans Study (CAHPS) is to develop an integrat... more The main goal of the Consumer Assessments of Health Plans Study (CAHPS) is to develop an integrated set of tested, standardized surveys to obtain meaningful information from health plan enrollees about their experiences. The CAHPS project benefits from the complementary strengths of psychometric and cognitive testing. The CAHPS team conducted 150 cognitive interviews across three organizations in different geographic locations using multiple interview methods with different consumer populations. This article explains how cognitive testing was used in the CAHPS survey development process and shares the main findings from the cognitive interviews. A modified report format is more appropriate when asking about specific aspects of plan enrollees' experiences, whereas a rating format is useful for asking about overall assessments. Specifying a longer reference period is preferable to asking about the most recent visit when capturing experiences with care, because some respondents get frustrated when they cannot include experiences other than the most recent visit. Explicit screeners and tailored inapplicable response categories are beneficial in mail questionnaires, so people know that they should not answer questions about which they have no relevant experience. Cognitive testing was integral in the development and refinement of the CAHPS instrument. The cognitive testing findings contributed to an improved instrument that should capture consumers' health care and plan experiences with less response error than one not subjected to such testing. The cognitive testing process and findings can be useful to other researchers with similar survey development goals.
An interactive videodisc (using a single screen Macintosh II, HyperCard driven, Level III, CAV in... more An interactive videodisc (using a single screen Macintosh II, HyperCard driven, Level III, CAV interactive videodisc) has been designed, produced, and pretested to permit patients with benign prostatic hyperplasia (BPH), facing a choice of surgery or watchful waiting, to take an active role in decision-making. The Informed Patient Decision-Making Procedure (IPDP) educates the patient about the benefits and harms of two treatment choices: prostatectomy and watchful waiting for BPH, by presenting patient-specific data derived from an analysis of medical outcomes. and video testimonials from patients with good and unfortunate outcomes of the therapeutic options. The IPDP standardizes the information provided to the patients, provides informed consent, gathers follow-up outcomes research data, and permits automated assessment of patient preferences and utilities. In this demonstration, the development of the IPDP is discussed, the videodisc program is presented, and lessons learned in creating medical videodiscs are shared.
In preparation for an outcomes study of benign prostatic hyperplasia (BPH), two measures of disea... more In preparation for an outcomes study of benign prostatic hyperplasia (BPH), two measures of disease-specific health status were developed to supplement a symptom score and overall health status measures. The symptom problem index (SPI) captures how troublesome patients find their urinary symptoms. The BPH impact index (BII) measures how much their urinary problems affect various domains of health. A prospective revalidation of the refined instruments (N = 108 BPH patients and 50 controls) documented that both indices had good internal consistency (Cronbach's alpha = 0.88 and 0.79, respectively) and test-retest (r = 0.88 for both) reliabilities, correlated strongly with symptom scores (r = 0.86 and 0.77), and discriminated between BPH and control subjects (receiver-operating characteristic areas = 0.87 and 0.85, respectively). These indices were nearly as responsive as symptom scores in 50 men actively treated for BPH, and much more responsive than a non-disease-specific General Health Index (GHI), a Mental Health Index (MHI), and an Activity Index (AI). Finally, these measures capture most of the health status significance of BPH symptoms. In linear regression models constructed to predict scores on the GHI, MHI, and AI, symptom scores added little explanatory power to the SPI and, particularly, to the BII. These measures help clarify how BPH affects overall health status and function. Such measures have an important role to play in studies of the outcomes of treatment for BPH, and probably for other conditions that interfere with health status and function.
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