Jack A. Clark

Sexuality after treatment for early prostate cancer: exploring the meanings of "erectile dysfunction".

AbstractOBJECTIVE: To explore perceptions of the impact of erectile dysfunction on men who had undergone definitive treatment for early nonmetastatic prostate cancer. DESIGN: Seven focus groups of men with early prostate cancer. The groups were semistructured to explore men’s experiences and quality-of-life concerns associated with prostate cancer and its treatment. SETTING: A staff model health maintenance organization, and a Veterans Affairs medical center. PATIENTS: Forty-eight men who had been treated for early prostate cancer 12 to 24 months previously. RESULTS: Men confirmed the substantial effect of sexual dysfunction on the quality of their lives. Four domains of quality of life related to men’s sexuality were identified: 1) the qualities of sexual intimacy; 2) everyday interactions with women; 3) sexual imagining and fantasy life; and 4) men’s perceptions of their masculinity. Erectile problems were found to affect men in both their intimate and nonintimate lives, including how they saw themselves as sexual beings. CONCLUSIONS: Erectile dysfunction, the most common side effect of treatment for early prostate cancer, has far-reaching effects upon men’s lives. Assessment of quality of life related to sexual dysfunction should address these broad impacts of erectile function on men’s lives. Physicians should consider these effects when advising men regarding treatment options. Physicians caring for patients who have undergone treatment should address these psychosocial issues when counseling men with erectile dysfunction.

Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: a prospective multiinstitutional outcomes study.

PURPOSE To use data from a prospective quality-of-life study to assess differences in disease-specific and general health-related quality-of-life changes after treatment with different external-beam irradiation techniques for prostate cancer. PATIENTS AND METHODS Patients were divided into three groups based on their pretreatment field size and planning technique: whole pelvis, small field, or conformal. Measures of bowel, urinary, and sexual function and of global health-related quality-of-life parameters (from the Health Survey Short Form [SF-36] and the Profile of Mood States [POMS]) were obtained from self-report questionnaires completed before initiation of therapy and at 3 and 12 months after therapy. RESULTS Irritative gastrointestinal and genitourinary side effects were frequent 3 months after treatment, but were substantially improved at 12 months. Sexual dysfunction increased steadily over the study period. The POMS and the SF-36 did not demonstrate significant changes over time. Despite small patient numbers, we found trends in favor of conformal therapy across several symptom measures, including sexual function. In the fatigue, energy, and vigor subscales, patients who received whole-pelvis treatment fared significantly worse than those in the other two groups. CONCLUSION Prospective, detailed data from a feasibility study allowed us to assess the effect of technique on quality of life following external-beam irradiation. Although limited by the small planned sample size, these results suggest that smaller radiation fields limit treatment-related complications, including, unexpectedly, sexual dysfunction. However, confirmation in a larger study is necessary.

Living With Treatment Decisions: Regrets and Quality of Life Among Men Treated for Metastatic Prostate Cancer

PURPOSE To examine variation in mens long-term regret of treatment decisions, ie, surgical versus chemical castration, for metastatic prostate cancer and its associations with quality of life. METHODS Survey of previously treated patients to assess treatment decisions and quality of life, supplemented with focus groups. Two items addressing whether a patient wished he could change his mind and the belief that he would have been better off with the treatment not chosen were combined in classifying survey respondents as either satisfied or regretful. Chi(2) and t tests were used to test associations between regret and treatment history, complications, and quality of life. RESULTS Survey respondents included 201 men aged 45 to 93 years (median, 71 years), who had begun treatment (71% chemical castration, 29% orchiectomy) a median of 2 years previously. Most reported complications: hot flashes (70%), nausea (34%), and erectile dysfunction (81%). Most were satisfied with the treatment decision, but 23% expressed regret. Regretful men more frequently reported surgical (43%) versus chemical (36%) castration (P: = .030) and nausea in the past week (54% v 32%; P: = .010) but less frequently reported erectile dysfunction (56% v 72%; P: = .048). Regretful men indicated poorer scores on every measure of generic and prostate cancer-related quality of life. Qualitative analyses revealed substantial uncertainty about the progress of their disease and the quality of the decisions in which patients participated. CONCLUSION Regret was substantial and associated with treatment choice and quality of life. It may derive from underlying psychosocial distress and problematic communication with physicians when decisions are being reached and over subsequent years.

Long-term treatment related complications of brachytherapy for early prostate cancer : A survey of patients previously treated

PURPOSE We determined long-term symptoms in patients after brachytherapy (radioactive seed implantation) for early (nonmetastatic) prostate cancer. MATERIALS AND METHODS We performed a cross-sectional survey of 105 (80% of those contacted) men treated at least 2 years 9 months (median 5.2 years) previously with brachytherapy alone (72 patients) or brachytherapy plus external beam radiation therapy (33) at a pioneering referral center for ultrasound guided brachytherapy. RESULTS Median patient age was 70 years at treatment and 75 years when surveyed. Bowel symptoms were uncommon (range 4% to 9%) unless patient had also received external beam radiation therapy. Urinary incontinence occurred in 45% of men, although leakage of more than a few drops, daily leakage and wearing absorptive pads occurred in 11%, 11% and 16%, respectively. Men who underwent documented transurethral prostatic resection were much more likely to report incontinence (83% versus 39%, p = 0.005) and those who underwent implantation less than 5 years earlier were less likely (33% versus 53%, respectively, p = 0.04). Complete impotence was common (50%) but impaired erections were more so (73%). Patients who received combined radiation treatment had more frequent erectile dysfunction. CONCLUSIONS Long-term bowel symptoms are infrequent after brachytherapy alone. Urinary incontinence is common, although usually only a few drops and not daily. Erectile dysfunction, prevalent in populations of older men, was found in most men. However, because our study design precluded documenting baseline symptoms before treatment and subsequent clinical interventions, the contribution of factors other than brachytherapy is unclear. The morbidity of patients receiving more recent brachytherapy may be less.

Improving the response choices on the veterans SF-36 health survey role functioning scales: results from the Veterans Health Study.

Abstract:Role functioning and its limitations due to ones health is an important aspect of health-related quality of life (HRQoL). The Medical Outcomes Study (MOS) SF-36 includes 2 role functioning scales: role limitations due to physical health problems (RP) or emotional problems (RE). Although they capture important concepts of HRQoL, these 2 scales have some limitations in their measurement properties. Using dichotomized sets of response choices, the scales are limited in their distributional properties (eg, higher standard deviation than other SF-36 scales) and ability to discriminate between clinically relevant groups. In this study, we ascertain the improvements to these 2 scales using 5-point ordinal response choices for each of the scale items. Two thousand one hundred sixty-two patients from the Veterans Health Study (VHS), an observational study of health outcomes in patients receiving ambulatory care, completed a health status questionnaire and a medical history. The health questionnaire included (1) the MOS SF-36, in which the RP and RE items used dichotomized yes/no responses; and (2) a set of modified RP and RE items that used 5-response choices for each of the items, ranging from “no, none of the time” to “yes, all of the time.” We compared the original and modified RP and RE scales using internal consistency reliability and factor analysis. We tested item convergent and discriminant validity using multitrait scaling, and scale discriminant validity using ordinary least squares regression. Results indicate that the modifications to the original RP and RE scales accomplish important gains in the distributional properties of the scales. The floor and ceiling effects of the 2 scales have been reduced and the reliability of the RP scale has increased (0.87–0.95). Factor analysis and multitrait scaling tests indicate that the modified items have the same interpretation as the original items. Tests of discriminant validity indicate that the modified RP and RE scales have greater explanatory power for measures of disease burden, depression, and disease severity. The modified SF-36 role scales are clearly superior to the original versions. The modifications have increased the explained variability, suggesting greater explanatory power and more information obtained by the role functioning measures. The modified RP and RE are capturing a wider spectrum of disease severity, in part due to the lowering of the floor and raising of the ceiling of the scales. Additional work needs to test these improvements in other populations and to expand the analysis to track the responsiveness of the modified scales to clinically and socially important changes over time.

Symptom indexes to assess outcomes of treatment for early prostate cancer.

Background.Patients’ perceptions of treatment outcomes are important in the management of early prostate cancer, but few studies have offered reliable and responsive measures to assess the likely side effects of the most common treatments. Objective.To develop indexes of urinary, bowel, and sexual function, and related distress. Research Design. Prospective cohort study of the outcomes of treatment for early prostate cancer, with self-administered questionnaires completed before treatment, and 3 and 12 months afterward. Hypothesized indexes, based on a clinical model of pathophysiological side effects of treatment, were defined and evaluated with respect to reliability and validity. Subjects.Patients (n = 184) undergoing radical prostatectomy or external beam radiotherapy for early prostate cancer. Measures.Urinary and bowel items pertained to frequency or intensity of symptoms of dysfunction; parallel items assessed symptom-related distress. Sexual dysfunction items assessed the quality of erections, orgasm, and ejaculation; distress was assessed by 2 items adapted from the MOS Sexual Problems (MOS-SP) scale. HRQoL was assessed by the SF-36 and Profile of Mood States. Results.Symptom and symptom-related distress indexes for urinary incontinence, urinary obstruction/irritation, bowel dysfunction, and sexual dysfunction were defined. Symptom and distress indexes in each domain were highly correlated. Responsiveness was substantial and varied by treatment in ways consistent with clinical experience. The indexes accounted for significant proportions of the variance in HRQoL measures. Conclusions.These indexes may be used in monitoring outcomes of treatment for early prostate cancer.

Racial differences in how patients perceive physician communication regarding cardiac testing.

Objectives. Recent studies documenting racial variation in the use of cardiac procedures highlight the need to understand if there are racial differences in processes of communication and decision making. Investigations of patients’ perceptions of their interaction with providers regarding cardiac testing were conducted. Methods. Four focus groups were convened with 13 patients who had undergone cardiac stress testing with positive results, stratified by race (white vs. black). Verbatim transcripts of discussions of their interactions with providers relating to their cardiac problems were analyzed qualitatively by a team of behavioral scientists and general internists to identify significant dimensions of communication and patient-provider relationships. Results. Four domains of communication were identified that appeared to bear on patients’ comfort and preferences regarding cardiac procedures. First, the substance of the information that was provided by physicians and other providers was described as incomplete, vague, ambiguous, and unclear. Second, some recommendations either were inconsistent with expectations or awakened fears based on distressing previous experiences. Third, patients said they needed to be convinced of the need for additional, invasive tests and therapeutic procedures, and in some cases providers’ arguments failed in this regard. Fourth, the patients highlighted the importance of trusting their provider. Although there were no apparent differences by race in patients’ perception of the information they received, black patients consistently expressed a preference for building a relationship with physicians (trust) before agreeing to an invasive cardiac procedure, and just as consistently complained that trust was lacking. Conversely, white patients tended to emphasize that they were inadequately convinced of the need for recommended procedures. Conclusions. This study provided qualitative information regarding patients’ perceptions of physician-patient communication and racial differences in such perceptions. For both black and white patients, we found problematic aspects of the patients’ experiences regarding communication about cardiac testing. Our findings suggest that although patients desire clarity from physicians, they are often confused regarding the information received. Both a lack of substance and vagueness of the information received may be linked to feelings of mistrust toward physicians when considering further diagnostic testing. Mistrust may be a source of some of the documented racial variation in health care utilization.

Measuring patients' perceptions of the outcomes of treatment for early prostate cancer.

Background. Compared with careful attention to the physical (eg, urinary, bowel, sexual) dysfunction that may follow treatment, little attention has been given to the behavioral, emotional, and interpersonal changes that the diagnosis of early prostate cancer and subsequent physical dysfunction may bring. Objective. To construct patient‐centered measures of the outcomes of treatment for early prostate cancer. Research Design. Qualitative study followed by survey of early prostate cancer patients and group of comparable patients with no history of prostate cancer. Analysis of focus groups identified relevant domains of quality of life, which were represented by Likert scale items included in survey questionnaires. Psychometric analyses of survey data defined scales evaluated with respect to internal consistency and validity. Results. Qualitative analysis identified three domains: urinary control, sexuality, and uncertainty about the cancer and its treatment. Psychometric analysis defined 11 scales. Seven were generically relevant to most older men: urinary control (eg, embarrassment with leakage), sexual intimacy (eg, anxiety about completing intercourse), sexual confidence (eg, comfort with sexuality), marital affection (eg, emotional distance from spouse/partner), masculine self esteem (eg, feeling oneself a whole man), health worry (eg, apprehensiveness about health changes), and PSA concern (eg, closely attending to ones PSA). Four scales were specific to the treatment experience: perceived cancer control, quality of treatment decision making, regret of treatment choice, and cancer‐related outlook. Conclusion. The scales provide definition and metrics for patient‐centered research in this area. They complement measures of physical dysfunction and bring into resolution outcomes of treatment that have gone unnoticed in previous studies.

Patient-reported measures of health: The Veterans Health Study.

Abstract:The goal of the Veterans Health Study (VHS) was to extend the work of the Medical Outcomes Study (MOS) into the VA, by developing methodology for monitoring patient-based outcomes of care for use in ambulatory outpatient care. The principal objective of the VHS was developing valid and reliable measures to assess general health-related quality of life (HRQoL) and identifying the presence of selected health conditions, their severity, and their impact on HRQoL. In this article, we provide an overview of the historical context, framework, objectives, and applications of the VHS for the purpose of assessing the health outcomes of veteran patients. The VHS is a prospective observational study that has followed 2425 VA patients for up to 2 years. The patients were sampled from users of the Veterans Affairs (VA) ambulatory care system in the Boston area. The health conditions selected were hypertension, diabetes, chronic lung disease, osteoarthritis of the knee, chronic low-back pain, and alcohol-related problems. These conditions were chosen because they are both prevalent in the VA and have measurable impacts on HRQoL. One of the cornerstones of the VHS was the development of the Veterans SF-36, modified from the MOS SF-36 for use in veteran ambulatory populations. Other key accomplishments included the development of patient-based disease-specific measures of health and the establishment of methods and logistics for comprehensive health outcomes research in large health care systems such as the VA, using these patient-based measures. Selected measures developed in the VHS, eg, the Veterans SF-36, have been integrated into the VA outcomes measurement system. The scope of the VHS is unique; it resulted in the development of a broad range of patient-focused process and outcome measures, as well as methodologies for assessing large numbers of patients, that have been widely used in the VA outpatient health care system for monitoring health outcomes across the nation.

Changes in quality of life following treatment for early prostate cancer

OBJECTIVES To explore the effects of urinary, bowel, and sexual symptoms following treatment for early (nonmetastatic) prostate cancer on health-related quality of life through an examination of the responsiveness of the Medical Outcomes Study Short Form Health Survey (SF-36). METHODS We conducted a prospective observational cohort study of 125 men with early prostate cancer who underwent either radical prostatectomy or radical, external beam radiotherapy. Patients completed questionnaires, which included assessments of urinary, bowel, and sexual symptoms and the SF-36 at the time of their clinical consultation prior to deciding on primary therapy and at 3 and 12-month follow-up. RESULTS Although cross-sectional analysis showed substantial associations between symptoms and the eight scales of the SF-36 12 months after the initiation of treatment, longitudinal analyses of changes in these scales showed only modest effects. Three scales registered changes associated with the development of new symptoms: General Health Perceptions, Vitality, and Social Function. Role Performance with Emotional Limitations demonstrated a surprising response: slight improvements in men with new symptoms, compared with substantial gains in men who survived treatment without developing new urinary, bowel, or sexual symptoms. Overall, the SF-36 demonstrated a pattern of decline at 3 months and recovery to baseline at 12 months. Rather than registering declines in response to increasing symptoms, negative changes occurred primarily in men who presented symptoms prior to treatment and whose symptoms were unchanged 12 months later. CONCLUSIONS The SF-36 is associated with the presence of physical symptoms but demonstrates a complicated pattern of change following treatment and the development of new urinary, bowel, and sexual problems. Multidimensional approaches to the outcomes of treatment for early prostate cancer help to clarify the magnitude of both gains and losses in quality of life.