Decisions about medication use and cancer screening across age groups in the United States.

OBJECTIVE: To describe decision process and quality for common cancer screening and medication decisions by age group. METHODS: We included 2941 respondents to a national Internet survey who made at least one decision about colorectal, breast, and prostate cancer screening, blood pressure or cholesterol medications. Respondents were queried about decision processes. RESULTS: Across the five decisions considered, decision process scores were similar (and generally low) across age groups for medication and cancer screening, indicating that all groups had poor involvement in medical decision making. Overall knowledge scores were low across age groups, with elderly (75+) having slightly higher knowledge about medications vs. younger respondents. Elderly respondents reported similar goals and concerns when making decisions, though placed greater importance of having peace of mind from a normal result for cancer screening vs. younger respondents. CONCLUSION: Across age groups, respondents reported poor decision processes about common medications and cancer screening, despite little evidence of benefit for some interventions (cancer screening, cholesterol lowering medicines in low risk elderly) and possibility of harm in the elderly. PRACTICE IMPLICATIONS: Particular care should be taken to help patients understand both benefit and risk of screening tests and routine medications.

Psychosocial mechanisms of the pain and quality of life relationship for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

INTRODUCTION: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent, chronic pelvic pain condition largely unresponsive to medical interventions. Psychosocial risk factors are associated with poor outcomes in CP/CPPS, but have not been examined for their intervening roles between pain and reduced quality of life (QoL). This study aimed to determine if psychosocial risk factors (i.e., patient coping and catastrophizing) mediate the association between pain and QoL. METHODS: Using a cross sectional design, 175 men with CP/CPPS (mean age 46.83; SD 10.86) were recruited from tertiary care urology clinics and completed questionnaires on demographics, pain, QoL, pain coping, depression, and catastrophizing. An exploratory factor analysis was conducted and aggregate factor scores were examined to improve the amount of meaningful measurement to be used in multiple mediations. The models specified multiple risk factors as mechanisms between pain and both physical and mental QoL as the primary outcome measurements. RESULTS: Four aggregate psychosocial factor scores were produced from the psychosocial measures (i.e., illness and wellness-focused behavioural coping, depression and catastrophizing). Illness-focused coping partially mediated the relationship between pain and physical QoL. However, catastrophizing and illness-focused coping fully mediated the relation between pain and mental QoL, showing the association between pain and mental QoL was no longer significant when catastrophizing and illness-focused coping were in the model. CONCLUSION: Psychosocial factors function as mechanisms between higher pain and they are associated diminished mental QoL. These results introduce illness-focused coping as an important biopsychosocial target in CP/CPPS management.

Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial.

BACKGROUND: Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic. METHODS: This randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS symptoms. In 2006-2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed. RESULTS: Of 218 men assigned to receive pregabalin, 103 (47.2%) reported at least a 6-point decrease in the NIH-CPSI total score at 6 weeks compared with 35.8% (38 of 106 men) assigned to receive placebo (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites). Compared with the placebo group, men assigned to receive pregabalin experienced reductions in the NIH-CPSI total score and subscores (P < .05), a higher Global Response Assessment response rate (31.2% and 18.9%; P = .02), and improvement in total McGill Pain Questionnaire score (P = .01). Results for the other outcomes did not differ between groups. CONCLUSION: Pregabalin therapy for 6 weeks was not superior to placebo use in the rate of a 6-point decrease (improvement) in the NIH-CPSI total score in men with CP/CPPS. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00371033.

A survey of primary care physician practices in the diagnosis and management of women with interstitial cystitis/painful bladder syndrome.

OBJECTIVES: To describe the practice patterns among primary care physicians' (PCPs) managing patients with symptoms suggestive of interstitial cystitis/painful bladder syndrome (IC/PBS). METHODS: We developed a clinical vignette describing a woman with typical IC/PBS symptoms to elicit questions about etiology, management strategies, and familiarity with this syndrome. We mailed the questionnaire to 556 PCPs, including academicians and community physicians, in Boston, Los Angeles, and Chicago. RESULTS: We received 290 completed questionnaires (response rate, 52%). Nineteen percent of respondents reported they had "never" seen a patient like the one described in the vignette. Two-thirds of respondents correctly identified the hallmark symptom of IC/PBS (bladder pain/pressure). Regarding etiology, 90% correctly indicated that IC/PBS was a noninfectious disease, 76% correctly reported that it was not caused by a sexually transmitted infection, and 61% correctly indicated that it was not caused by a psychiatric illness. Common treatments included antibiotics and nonsteroidal anti-inflammatory agents. Referrals were often made to a specialist. CONCLUSIONS: Although most PCPs indicate familiarity with IC/PBS, they manage the condition infrequently. They also appear to have significant knowledge deficits about the clinical characteristics of IC/PBS, and they indicate variable practice patterns in the diagnosis and treatment of the condition. Educational efforts directed at PCPs will likely improve the care of patients with IC/PBS.

Validation of a modified National Institutes of Health chronic prostatitis symptom index to assess genitourinary pain in both men and women.

OBJECTIVES: To date, separate condition-specific instruments have been used to assess severity of symptoms, in men and women with urological pain conditions. We developed a single instrument that can be used to assess treatment response in clinical trials and cohort studies that involve both genders. METHODS: We developed the Genitourinary Pain Index (GUPI) by modifying and adding questions to the National Institutes of Health-Chronic Prostatitis Symptom Index. To assess discriminant validity, concurrent validity, and reliability, we administered the GUPI to 1653 men and 1403 women in a large managed care population. To assess responsiveness, we administered the GUPI to 47 men and women who completed a National Institutes of Health-sponsored trial of pelvic floor physical therapy. RESULTS: The GUPI discriminated between men with chronic prostatitis or interstitial cystitis, those with other symptomatic conditions (dysuria, frequency, chronic cystitis), and those with none of these diagnoses (P <.05). It also discriminated between women with interstitial cystitis, those with incontinence, and those with none of these diagnoses (P <.05). The GUPI demonstrated good internal consistency within subscale domains, and GUPI scores correlated highly with scores on the Interstitial Cystitis Symptom Index and Problem Index. The GUPI was highly responsive to change, and the change in score was similar in both male and female responders. A reduction of 7 points robustly predicted being a treatment responder (sensitivity 100%, specificity 76%). CONCLUSIONS: The GUPI is a valid, reliable, and responsive instrument that can be used to assess the degree of symptoms in both men and women with genitourinary pain complaints.

Prostate cancer screening decisions: results from the National Survey of Medical Decisions (DECISIONS study).

BACKGROUND: Guidelines recommend informing patients about the risks and benefits of prostate cancer screening. We evaluated the medical decision-making process for prostate-specific antigen (PSA) testing. METHODS: We conducted a telephone survey of a randomly selected national sample of 3010 English-speaking US adults 40 years and older. Included in the survey were 375 men who had either undergone or discussed (with health care providers [HCPs]) PSA testing in the previous 2 years. We asked subjects about sociodemographic characteristics, prostate cancer screening discussion features, prostate cancer knowledge, and the importance of various decision factors and sources of information. RESULTS: Overall, 69.9% of subjects discussed screening before making a testing decision, including 14.4% who were not tested. Health care providers most often (64.6%) raised the idea of screening, and 73.4% recommended PSA testing. Health care providers emphasized the pros of testing in 71.4% of discussions but infrequently addressed the cons (32.0%). Although 58.0% of subjects felt well-informed about PSA testing, 47.8% failed to correctly answer any of the 3 knowledge questions. Only 54.8% of subjects reported being asked for their screening preferences. An HCP recommendation (odds ratio, 2.67; 95% confidence interval, 1.08-6.58) was the only discussion characteristic associated with testing. Valuing HCP information was also associated with testing (odds ratio, 1.26; 95% confidence interval, 1.04-1.54). CONCLUSIONS: Recommendations and information from HCPs strongly influenced testing decisions. However, most prostate cancer screening decisions did not meet criteria for shared decision making because subjects did not receive balanced discussions of decision consequences, had limited knowledge, and were not routinely asked for their preferences.

Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome.

BACKGROUND: In men with chronic prostatitis-chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis-chronic pelvic pain syndrome. Participation in the study required diagnosis of the condition within the preceding 2 years and no previous treatment with an alpha-adrenergic receptor blocker. Men were randomly assigned to treatment for 12 weeks with either 10 mg of alfuzosin per day or placebo. The primary outcome was a reduction of at least 4 points (from baseline to 12 weeks) in the score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (range, 0 to 43; higher scores indicate more severe symptoms). A 4-point decrease is the minimal clinically significant difference in the score. RESULTS: A total of 272 eligible participants underwent randomization, and in both study groups, 49.3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin, 0.1%; 95% confidence interval, -11.2 to 11.0; P=0.99). In addition, a global response assessment showed similar response rates at 12 weeks: 33.6% in the placebo group and 34.8% in the alfuzosin group (P=0.90). The rates of adverse events in the two groups were also similar. CONCLUSIONS: Our findings do not support the use of alfuzosin to reduce the symptoms of chronic prostatitis-chronic pelvic pain syndrome in men who have not received prior treatment with an alpha-blocker. (ClinicalTrials.gov number, NCT00103402.)

Category III chronic prostatitis/chronic pelvic pain syndrome: insights from the National Institutes of Health Chronic Prostatitis Collaborative Research Network studies.

Chronic prostatitis/chronic pelvic pain syndrome remains an enigmatic medical condition. Creation of the National Institutes of Health-funded Chronic Prostatitis Collaborative Research Network (CPCRN) has stimulated a renewed interest in research on and clinical aspects of chronic prostatitis/chronic pelvic pain syndrome. Landmark publications of the CPCRN document a decade of progress. Insights from these CPCRN studies have improved our management of chronic prostatitis/chronic pelvic pain syndrome and offer hope for continued progress.

Excessive antibiotic use in men with prostatitis.

BACKGROUND: Prostatitis accounts for 2 million outpatient visits annually. The majority of prostatitis cases fit the definition of chronic pelvic pain syndrome, for which routine antibiotic use is not indicated. METHODS: Inpatient, outpatient, and pharmacy datasets from the Veterans Health Administration were used to quantify the magnitude of antibiotic use attributable to chronic pelvic pain syndrome. Specifically, men with a diagnosis of infectious/acute prostatitis or a urinary tract infection were excluded, and the remaining men with a diagnosis of prostatitis were defined as having chronic pelvic pain syndrome. RESULTS: The annual prevalence of chronic pelvic pain syndrome was 0.5%. Prescriptions for fluoroquinolone antibiotics were filled in 49% of men with a diagnosis of chronic pelvic pain syndrome compared with 5% in men without chronic pelvic pain syndrome. Men with chronic pelvic pain syndrome were more than 7 times more likely to receive a fluoroquinolone prescription independently of age, race/ethnicity, and comorbid conditions. Increased use of other antibiotics also was observed. High use was similar in men with either infectious/acute prostatitis or chronic pelvic pain syndrome. CONCLUSION: Despite evidence that antibiotics are not effective in the majority of men with chronic pelvic pain syndrome, they were prescribed in 69% of men with this diagnosis. Some increased use is probably due to uncontrolled confounding by comorbid conditions or inaccurate diagnostic coding. However, a 7-fold higher rate of fluoroquinolone usage suggests that strategies to reduce unnecessary antibiotic use in men with prostatitis are warranted.

Use of androgen deprivation therapy for metastatic prostate cancer in older men.

OBJECTIVE: To assess factors associated with early or delayed androgen deprivation therapy (ADT) among men diagnosed with metastatic prostate cancer, and to assess the relationship between ADT and overall survival, as there is uncertainty about the ideal timing for initiating ADT in men with metastatic prostate cancer. PATIENTS AND METHODS: We studied a population-based cohort of American men aged >or=66 years diagnosed with metastatic prostate cancer during 1992-2002 and followed to 2003. We assessed the receipt of ADT early (4 months), or not at all, using multinomial logistic regression to identify factors associated with treatment, and Cox proportional-hazard models to assess whether treatment was associated with survival. RESULTS: Overall, 69.5% of men received early ADT and 7.3% delayed. Adjusted rates of early ADT were lower for black than white men (58.3% vs 71.0%), and of delayed ADT were higher for black than white men (12.7% vs 6.2%). Receipt of ADT was associated with improved survival (adjusted hazard ratio 0.69, 95% confidence interval 0.66-0.73). The benefit of early treatment did not differ from delayed treatment (P = 0.58). CONCLUSIONS: A large minority of men with metastatic prostate cancer, particularly black men, receive delayed or no ADT. Early or delayed ADT was associated with similarly prolonged survival. After controlling for patient and tumour characteristics, survival did not differ by race, and receipt of ADT did not contribute to racial differences in survival.

Psychosocial variables affect the quality of life of men diagnosed with chronic prostatitis/chronic pelvic pain syndrome.

OBJECTIVE: To examine interactions between demographic, pain, urinary, psychological and environmental predictors of quality of life (QOL) in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: In all, 253 men previously enrolled in the National Institutes of Health Chronic Prostatitis Cohort study in North American tertiary-care clinical centres (six in the USA and one in Canada) self-reported with validated instruments, including the QOL subscales of the Short Form-12 (physical, SF12-PCS; and mental, SF12-MCS), demographics, urinary symptoms, depression, current pain, pain coping, 'catastrophizing' (catastrophic thinking about pain), pain control, social support and solicitous responses from a partner. Data were collected through a one-time survey. Covariates determined to be significant were entered into a multivariable regression model predicting SF12-PCS and SF12-MCS. RESULTS: Adjusting for covariates, regression models showed that poorer SF12-PCS scores were predicted by worse urinary function (P < 0.001) and increased use of pain-contingent resting as a coping strategy (P = 0.026). Further, poorer SF12-MCS scores were predicted by greater pain catastrophizing (P = 0.002) and lower perceptions of social support (P< 0.001). In separate follow-up analyses, helplessness was the significant catastrophizing subscale (P < 0.001), while support from family and friends were the significant social support subscales (P = 0.002 and <0.001). CONCLUSIONS: These data suggest that specific coping and environmental factors (i.e. catastrophizing, pain-contingent resting, social support) are significant in understanding how patients with CP/CPPS adjust. These data can be used to develop specific cognitive-behavioural programmes for men with CP/CPPS who are refractory to standard medical therapy.

Overlap of different urological symptom complexes in a racially and ethnically diverse, community-based population of men and women.

OBJECTIVE: To define the prevalence and overlap of symptom patterns traditionally associated with benign prostatic hyperplasia, chronic prostatitis/chronic pelvic pain syndrome, interstitial cystitis/painful bladder syndrome, and incontinence among men and women in a racially and ethnically diverse, community-based population. SUBJECTS AND METHODS: In all, 5506 men and women aged 30-79 years were recruited to participate in the Boston Area Community Health Survey, using a stratified-cluster sampling technique to obtain roughly similar representative samples by age group, gender and race/ethnicity (White, Black, Hispanic). Survey data were collected by bilingual interviewers in subjects' homes. Scales measuring symptom patterns were derived from validated instruments, with minor changes to eliminate different recall periods and overlap in items that might have confused subjects. RESULTS: About a quarter of men and women of all ages met the definition for one or more of the target symptom patterns; there was no significant variation in the prevalence of any of the symptom patterns by race/ethnicity. Overall, approximately 16% of men and women had one symptom pattern, while 7% had overlap patterns. Except for urinary incontinence and interstitial cystitis/painful bladder syndrome in both men and women, the prevalence of all symptom complexes were associated with one another significantly more often that would be expected by chance. CONCLUSIONS: Overlapping patterns of lower urinary tract symptoms and pelvic pain are common. These overlapping patterns present challenges for clinical practice and research, and require further investigation of their causes, diagnosis and optimum treatment.

The association of abuse and symptoms suggestive of chronic prostatitis/chronic pelvic pain syndrome: results from the Boston Area Community Health survey.

OBJECTIVE: To determine the effect of reported sexual, physical, or emotional abuse on the symptoms suggestive of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to determine the effect of race/ethnicity on these patterns. METHODS: The Boston Area Community Health (BACH) survey used a multi-stage stratified cluster sample to randomly sample 5,506 adults aged 30-79 from the city of Boston. BACH recruited 2,301 men (700 Black, 766 Hispanic, and 835 White). Interviewers administered questions approximating the National Institutes of Health chronic prostatitis symptom index (CPSI), and symptoms suggestive of CP/CPPS were measured by the definition of perineal and/or ejaculatory pain and CPSI pain score of 4+. Questions about previous abuse were obtained from a validated self-administered questionnaire during the home visit. Logistic regression was used to determine the effect of abuse on the likelihood of a man having symptoms suggestive of CP/CPPS. RESULTS: The prevalence of symptoms suggestive of CP/CPPS was 6.5%. Men who reported having experienced sexual, physical, or emotional abuse had increased odds (1.7-3.3) for symptoms suggestive of CP/CPPS. Previous abuse increased both the pain and urinary scores from the CPSI. CONCLUSION: Symptoms suggestive of CP/CPPS are not uncommon in a community-based population of men. For men presenting with symptoms suggestive of CP/CPPS, clinicians may wish to consider screening for abuse.

Prostatitis.

PURPOSE: We quantified the burden of prostatitis in the United States by identifying trends in the use of health care resources and estimating the economic impact of the disease. MATERIALS AND METHODS: The analytical methods used to generate these results were described previously. RESULTS: The rate of national inpatient hospitalizations for a diagnosis of prostatitis decreased by 21% between 1994 and 2000. Hospitalization rates were 2 to 2.5 times higher for Medicare beneficiaries with a 42% decrease between 1992 and 2001. Combined physician outpatient and hospital outpatient visits revealed an age adjusted, annualized visit rate for prostatitis of 1,798/100,000 population. More than 6% of visits with a primary diagnosis of prostatitis had a concomitant diagnosis of benign prostatic hyperplasia. The most common medications associated with any visits for prostatitis were quinolones (annualized rate 319/100,000 population) and the rate remained about the same even after visits for infectious prostatitis were removed from the data. The cost of prostatitis was about $84 million annually, exclusive of pharmaceutical spending. Of 897 privately insured men with a medical claim for prostatitis in 2002, 14% missed some work because of the condition. CONCLUSIONS: Overall spending in the United States for the diagnosis and management of prostatitis, exclusive of pharmaceutical spending, totaled $84 million in 2000 and it appears to be increasing with time. Given the extensive gaps in our understanding of the diagnosis of and treatment for prostatitis, many of these expenditures may represent a waste of resources.

Catastrophizing and pain-contingent rest predict patient adjustment in men with chronic prostatitis/chronic pelvic pain syndrome.

UNLABELLED: Cognitive/behavioral and environmental variables are significant predictors of patient adjustment in chronic pain. Using a biopsychosocial template and selecting several pain-relevant constructs from physical, cognitive/behavioral, and environmental predictors, outcomes of pain and disability in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) were explored. Men (n = 253) from a North American multi-institutional NIH-funded Chronic Prostatitis Cohort Study in 6 US and 1 Canadian centers participated in a survey examining pain and disability. Measures included demographics, urinary symptoms, depression, pain, disability, catastrophizing, control over pain, pain-contingent rest, social support, and solicitous responses from a significant other. Regressions showed that urinary symptoms (beta = .20), depression (beta = .24), and helplessness catastrophizing (beta = .29) predicted overall pain. Further, affective pain was predicted by depression (beta = .39) and helplessness catastrophizing (beta = .44), whereas sensory pain was predicted by urinary symptoms (beta = .25) and helplessness catastrophizing (beta = .37). With regard to disability, urinary symptoms (beta = .17), pain (beta = .21), and pain-contingent rest (beta = .33) were the predictors. These results suggest cognitive/behavioral variables (ie, catastrophizing, pain-contingent rest) may have significant impact on patient adjustment in CP/CPPS. Findings support the need for greater research of such pain-related variables in CP/CPPS. PERSPECTIVE: This article explores predictors of patient adjustment in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Cognitive/behavioral variables of catastrophizing and pain-contingent rest respectively predicted greater pain and disability. Catastrophic helplessness was a prominent pain predictor. These findings inform clinicians and researchers on several new variables in CP/CPPS outcomes and suggest future research.

The impact of a suspicious prostate biopsy on patients' psychological, socio-behavioral, and medical care outcomes.

OBJECTIVE: To evaluate the psychological, socio-behavioral, and medical implications of apparently false-positive prostate cancer screening results. METHODS: One hundred and twenty-one men with a benign prostate biopsy performed in response to a suspicious screening test (biopsy group) and 164 men with a normal prostate-specific antigen (PSA) test result (normal PSA group) responded to a questionnaire 6 weeks, 6 and 12 months after their biopsy or PSA test. RESULTS: The mean (+/-SD) age of respondents was 61+/-9 years (range, 41 to 88 years). One year later, 26% (32/121) of men in the biopsy group reported having worried "a lot" or "some of the time" that they may develop prostate cancer, compared with 6% (10/164) in the normal PSA group (P<.001). Forty-six percent of the biopsy group reported thinking their wife or significant other was concerned about prostate cancer, versus 14% in the normal PSA group (P<.001). Medical record review showed that biopsied men were more likely than those in the normal PSA group to have had at least 1 follow-up PSA test over the year (73% vs 42%, P<.001), more likely to have had another biopsy (15% vs 1%, P<.001), and more likely to have visited a urologist (71% vs 13%, P<.001). CONCLUSION: One year later, men who underwent prostate biopsy more often reported worrying about prostate cancer. In addition, there were related psychological, socio-behavioral, and medical care implications. These hidden tolls associated with screening should be considered in the discussion about the benefits and risks of prostate cancer screening.

A prospective study of symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome: the National Institutes of Health Chronic Prostatitis Cohort study.

PURPOSE: We present the results of 2 years of symptom and quality of life followup of men with CP/CPPS enrolled in the CPC. MATERIALS AND METHODS: We followed 445 subjects from 6 clinical centers across North America for 2 years with outcome measures that included the NIH-CPSI, quality of life, and GRA. All subjects were treated according to usual care practices at each clinical site. RESULTS: Of the 445 subjects 293 had complete data at 2 years. Withdrawals were younger, had been diagnosed more recently and had higher baseline symptoms. Among the 293 men the mean improvement at 2 years was 5 points on the 43-point NIH-CPSI total score. Most of the observed improvement occurred in the first 3 months of followup. Among all 445 subjects, retaining withdrawals in the denominator, 31% considered themselves moderately or markedly improved at 2 years. Although group mean symptom scores were stable and improved slightly over time, some individual subjects reported large fluctuations. No baseline demographic or clinical factors significantly predicted changes in symptom scores over time. CONCLUSIONS: CP/CPPS is a chronic disease characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of followup, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period.