Michele G. Sullivan

Holistic, person-centered care can reduce symptoms of agitation in dementia patients, compared with the effects of standard long-term care, a randomized controlled trial by Australian researchers indicates.

Focusing on the patient as a whole and seeking to make the most of his or her remaining abilities is also economical and easy to implement, the researchers recently reported (Lancet Neurol. 2009;8:317-25).

“Care that addresses residents' total human needs can mitigate cognitive and functional deterioration,” asserted the team led by Lynn Chenoweth, Ph.D., of the University of New South Wales, Sydney.

The Caring for Aged Dementia Care Residents Study (CADRES) was composed of 289 residents living in 15 Australian long-term care facilities. All of the residents had progressive dementia with persistent behaviors that made it difficult for staff to care for them.

The facilities were randomized to three interventions: usual care, person-centered care, and dementia-care mapping, which includes person-centered care.

The researchers provided staff training in the facilities randomized to one of the experimental plans. The person-centered care training consisted of a 2-day session for two staff members of each facility, who then developed and implemented practices in their respective facilities. Training stressed that behavior is a form of communication and that feelings persist in individuals despite cognitive decline.

Trainees were encouraged to focus on “the unique way those residents express feelings and needs” and how staff actions could address individuals' preferences and needs.

Dementia-mapping care training also consisted of a 2-day session for two staff members per facility, and they, too, then helped their colleagues implement the approach.

This system of care entails observation of which care factors most affect resident behavior, either negatively or positively. Daily observations are then integrated into a person-centered care plan.

Care continued as usual at the control sites, characterized by custodial tasks, physical restraint, and “a tendency to neglect residents' psychosocial needs when meeting activities of daily living,” according to the researchers. Staff at these facilities paid little attention to promoting choice and encouraging self-determination by residents with dementia, according to Dr. Chenoweth and her colleagues.

Outcome measures included the 29-item Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory for the Nursing Home, and the Quality of Life in Late-Stage Dementia (QUALID) scale. Outcomes were measured at baseline, after 4 months of intervention that included telephone support by the researchers, and again 4 months after that (8 months after the start of the study).

The patients' average age at baseline was 84 years. Their average dementia score was 5.2 on the Global Deterioration Scale, indicating moderate dementia, according to the researchers.

At 4 and 8 months, agitation had increased in the control group but decreased in residents under the experimental care approaches.

The standard-care residents' CMAI scores went up 9 points on average at 4 months and 8 points at 8 months. In contrast, the agitation scores went down 6 points by the study's end (8 months) in the person-centered care recipients and by 2 points in the dementia-care mapping group.

The neuropsychiatric inventory score decreased significantly only in the person-centered care group, where it dropped a mean of almost 7 points at 4 months and another 2 points at 8 months.

There was no significant change in the quality of life scores for any group. Nor was there any indication that either experimental care approach decreased accidents, hospital admissions, drug costs, or the need for psychotropic medications.

However, the investigators noted, the dementia-care mapping group did experience a significant decrease in the number of falls, while the person-centered care and usual care groups saw increases in falls.

The costs of implementing the care programs differed significantly. The additional cost per site for dementia-mapping care was $6,654, compared with $1,492 for person-centered care. The researchers also estimated the cost per average point drop in agitation on the CMAI scale. Again, person-centered care was more economical than dementia-mapping care ($5.30 vs. $32.46, respectively).

The study affirmed previous findings that person-centered care is a valuable way to decrease agitation in dementia patients without resorting to drugs, Dr. Clive Ballard and Dr. Dag Aarsland, both of King's College, London, wrote in an editorial accompanying the report.

They added that the study also provided valuable information about the usefulness of dementia-mapping care, which had not been fully investigated.

The commenters offered a few caveats about the CADRES study, saying that any intervention can result in nonspecific benefits when compared with standard care.

Also, the study period was too short to fully determine the possible benefit of each intervention, wrote Dr. Ballard and Dr. Aarsland.

“Despite the caveats, CADRES is of major importance in showing the value of dementia-care mapping as an effective approach to reducing agitation in care-home residents with dementia,” they said.

“Further research should build on this finding to develop an intervention that can improve other neuropsychiatric symptoms, reduce inappropriate prescribing of psychotropic drugs, and hopefully lead to direct improvement in the quality of life of care-home residents.”

Holistic, person-centered care can reduce symptoms of agitation in dementia patients, compared with the effects of standard long-term care, a randomized controlled trial by Australian researchers indicates.

Focusing on the patient as a whole and seeking to make the most of his or her remaining abilities is also economical and easy to implement, the researchers recently reported (Lancet Neurol. 2009;8:317-25).

“Care that addresses residents' total human needs can mitigate cognitive and functional deterioration,” asserted the team led by Lynn Chenoweth, Ph.D., of the University of New South Wales, Sydney.

The Caring for Aged Dementia Care Residents Study (CADRES) was composed of 289 residents living in 15 Australian long-term care facilities. All of the residents had progressive dementia with persistent behaviors that made it difficult for staff to care for them.

The facilities were randomized to three interventions: usual care, person-centered care, and dementia-care mapping, which includes person-centered care.

The researchers provided staff training in the facilities randomized to one of the experimental plans. The person-centered care training consisted of a 2-day session for two staff members of each facility, who then developed and implemented practices in their respective facilities. Training stressed that behavior is a form of communication and that feelings persist in individuals despite cognitive decline.

Trainees were encouraged to focus on “the unique way those residents express feelings and needs” and how staff actions could address individuals' preferences and needs.

Dementia-mapping care training also consisted of a 2-day session for two staff members per facility, and they, too, then helped their colleagues implement the approach.

This system of care entails observation of which care factors most affect resident behavior, either negatively or positively. Daily observations are then integrated into a person-centered care plan.

Care continued as usual at the control sites, characterized by custodial tasks, physical restraint, and “a tendency to neglect residents' psychosocial needs when meeting activities of daily living,” according to the researchers. Staff at these facilities paid little attention to promoting choice and encouraging self-determination by residents with dementia, according to Dr. Chenoweth and her colleagues.

Outcome measures included the 29-item Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory for the Nursing Home, and the Quality of Life in Late-Stage Dementia (QUALID) scale. Outcomes were measured at baseline, after 4 months of intervention that included telephone support by the researchers, and again 4 months after that (8 months after the start of the study).

The patients' average age at baseline was 84 years. Their average dementia score was 5.2 on the Global Deterioration Scale, indicating moderate dementia, according to the researchers.

At 4 and 8 months, agitation had increased in the control group but decreased in residents under the experimental care approaches.

The standard-care residents' CMAI scores went up 9 points on average at 4 months and 8 points at 8 months. In contrast, the agitation scores went down 6 points by the study's end (8 months) in the person-centered care recipients and by 2 points in the dementia-care mapping group.

The neuropsychiatric inventory score decreased significantly only in the person-centered care group, where it dropped a mean of almost 7 points at 4 months and another 2 points at 8 months.

There was no significant change in the quality of life scores for any group. Nor was there any indication that either experimental care approach decreased accidents, hospital admissions, drug costs, or the need for psychotropic medications.

However, the investigators noted, the dementia-care mapping group did experience a significant decrease in the number of falls, while the person-centered care and usual care groups saw increases in falls.

The costs of implementing the care programs differed significantly. The additional cost per site for dementia-mapping care was $6,654, compared with $1,492 for person-centered care. The researchers also estimated the cost per average point drop in agitation on the CMAI scale. Again, person-centered care was more economical than dementia-mapping care ($5.30 vs. $32.46, respectively).

The study affirmed previous findings that person-centered care is a valuable way to decrease agitation in dementia patients without resorting to drugs, Dr. Clive Ballard and Dr. Dag Aarsland, both of King's College, London, wrote in an editorial accompanying the report.

They added that the study also provided valuable information about the usefulness of dementia-mapping care, which had not been fully investigated.

The commenters offered a few caveats about the CADRES study, saying that any intervention can result in nonspecific benefits when compared with standard care.

Also, the study period was too short to fully determine the possible benefit of each intervention, wrote Dr. Ballard and Dr. Aarsland.

“Despite the caveats, CADRES is of major importance in showing the value of dementia-care mapping as an effective approach to reducing agitation in care-home residents with dementia,” they said.

“Further research should build on this finding to develop an intervention that can improve other neuropsychiatric symptoms, reduce inappropriate prescribing of psychotropic drugs, and hopefully lead to direct improvement in the quality of life of care-home residents.”

Holistic, person-centered care can reduce symptoms of agitation in dementia patients, compared with the effects of standard long-term care, a randomized controlled trial by Australian researchers indicates.

Focusing on the patient as a whole and seeking to make the most of his or her remaining abilities is also economical and easy to implement, the researchers recently reported (Lancet Neurol. 2009;8:317-25).

“Care that addresses residents' total human needs can mitigate cognitive and functional deterioration,” asserted the team led by Lynn Chenoweth, Ph.D., of the University of New South Wales, Sydney.

The Caring for Aged Dementia Care Residents Study (CADRES) was composed of 289 residents living in 15 Australian long-term care facilities. All of the residents had progressive dementia with persistent behaviors that made it difficult for staff to care for them.

The facilities were randomized to three interventions: usual care, person-centered care, and dementia-care mapping, which includes person-centered care.

The researchers provided staff training in the facilities randomized to one of the experimental plans. The person-centered care training consisted of a 2-day session for two staff members of each facility, who then developed and implemented practices in their respective facilities. Training stressed that behavior is a form of communication and that feelings persist in individuals despite cognitive decline.

Trainees were encouraged to focus on “the unique way those residents express feelings and needs” and how staff actions could address individuals' preferences and needs.

Dementia-mapping care training also consisted of a 2-day session for two staff members per facility, and they, too, then helped their colleagues implement the approach.

This system of care entails observation of which care factors most affect resident behavior, either negatively or positively. Daily observations are then integrated into a person-centered care plan.

Care continued as usual at the control sites, characterized by custodial tasks, physical restraint, and “a tendency to neglect residents' psychosocial needs when meeting activities of daily living,” according to the researchers. Staff at these facilities paid little attention to promoting choice and encouraging self-determination by residents with dementia, according to Dr. Chenoweth and her colleagues.

Outcome measures included the 29-item Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory for the Nursing Home, and the Quality of Life in Late-Stage Dementia (QUALID) scale. Outcomes were measured at baseline, after 4 months of intervention that included telephone support by the researchers, and again 4 months after that (8 months after the start of the study).

The patients' average age at baseline was 84 years. Their average dementia score was 5.2 on the Global Deterioration Scale, indicating moderate dementia, according to the researchers.

At 4 and 8 months, agitation had increased in the control group but decreased in residents under the experimental care approaches.

The standard-care residents' CMAI scores went up 9 points on average at 4 months and 8 points at 8 months. In contrast, the agitation scores went down 6 points by the study's end (8 months) in the person-centered care recipients and by 2 points in the dementia-care mapping group.

The neuropsychiatric inventory score decreased significantly only in the person-centered care group, where it dropped a mean of almost 7 points at 4 months and another 2 points at 8 months.

There was no significant change in the quality of life scores for any group. Nor was there any indication that either experimental care approach decreased accidents, hospital admissions, drug costs, or the need for psychotropic medications.

However, the investigators noted, the dementia-care mapping group did experience a significant decrease in the number of falls, while the person-centered care and usual care groups saw increases in falls.

The costs of implementing the care programs differed significantly. The additional cost per site for dementia-mapping care was $6,654, compared with $1,492 for person-centered care. The researchers also estimated the cost per average point drop in agitation on the CMAI scale. Again, person-centered care was more economical than dementia-mapping care ($5.30 vs. $32.46, respectively).

The study affirmed previous findings that person-centered care is a valuable way to decrease agitation in dementia patients without resorting to drugs, Dr. Clive Ballard and Dr. Dag Aarsland, both of King's College, London, wrote in an editorial accompanying the report.

They added that the study also provided valuable information about the usefulness of dementia-mapping care, which had not been fully investigated.

The commenters offered a few caveats about the CADRES study, saying that any intervention can result in nonspecific benefits when compared with standard care.

Also, the study period was too short to fully determine the possible benefit of each intervention, wrote Dr. Ballard and Dr. Aarsland.

“Despite the caveats, CADRES is of major importance in showing the value of dementia-care mapping as an effective approach to reducing agitation in care-home residents with dementia,” they said.

“Further research should build on this finding to develop an intervention that can improve other neuropsychiatric symptoms, reduce inappropriate prescribing of psychotropic drugs, and hopefully lead to direct improvement in the quality of life of care-home residents.”

Large-scale screening for ovarian cancer with a combination of transvaginal ultrasound and cancer antigen 125 is a feasible strategy that can accurately identify early cancers, a large U.K. trial of almost 203,000 women concluded.

The combination approach carried a sensitivity of 89% and specificity of 99.8% for both primary ovarian and tubal cancers. A comparison strategy that included only transvaginal ultrasound was just as sensitive but significantly less specific, Usha Menon, Ph.D., and colleagues wrote.

Although the two methods detected similar numbers of cancers, the ultrasound-only method identified significantly more borderline ovarian tumors, resulting in almost nine times as many surgeries (845 vs. 97), wrote Dr. Menon, of the University College London, and coauthors (Lancet Oncol. 2009 March 10 [doi:10.1016/S1470–2045(09)70026–9]).

“This highlights an issue that has already become a significant problem in other cancer-screening strategies—the detection of cancers that may never have been diagnosed in an individual's lifetime had [the patients] not been screened,” the investigators noted.

Any cancer screening trial, no matter how impressive, needs to be viewed in light of the overdiagnosis issue, said Dr. Saundra Buys of the University of Utah, Salt Lake City.

“If you have to perform 30 surgeries to cure one cancer, but a patient dies from a surgical complication, you're not really ahead in the game,” she said in an interview. “In this case, we have almost 950 women undergoing surgery with general anesthetic, with all its attendant risks,” to find 87 cancers, 28 of which were borderline tumors. “Some of these would never have caused any health problems had they never been discovered.”

The 4-year U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) comprised 202,638 postmenopausal women (mean age, 60 years). They were randomized to no screening, to annual screening with transvaginal ultrasound, or to annual screening with CA 125 and transvaginal ultrasound as a second-line test.

In the multimodal screening (MMS) group, women with an abnormal CA 125 had either a repeat CA 125 in 12 weeks or an ultrasound in 6 weeks, depending on their other risk factors. On the basis of these results, they could be returned to annual screening or slated for additional testing and clinical assessment.

In the ultrasound-only screening (USS) group, women with abnormal transvaginal ultrasound findings underwent a repeat ultrasound. Depending on these results, they were returned to the screening pool, scheduled for another ultrasound, or referred for clinical assessment.

In the MMS group, 9% of women required a repeat test, and 0.2% underwent surgery. In the USS group, 12% of women required a repeat test and 2% underwent surgery, a ratio of nine surgeries in the USS group for every one in the MSS group.

Of those who underwent surgery, 834 had benign ovarian pathology or normal ovaries, with a significantly higher occurrence in the USS group compared with the MSS group (787 vs. 47). Of these women, 24 (3%) experienced a major surgical complication, with the preponderance again occurring in the USS group (22 vs. 2).

Complications included six perforations of a hollow organ, two excessive hemorrhages requiring additional surgery, one readmission for portal site pain with surgery to remove an endometriotic nodule and residual ovary, one pulmonary embolism, two deep vein thromboses, four wound dehiscences, one wound hematoma, two hernias, one significant case of ileus, one bowel obstruction, one bowel fistula, and two significant infections.

The two screening strategies detected similar numbers of ovarian or tubal malignancies (USS 45, MSS 42). But more borderline tumors were detected in the USS group (20 vs. 8). There was no significant between-group difference in the number of stage II borderline cancers.

For all primary ovarian and tubal cancers, MSS had a sensitivity of 89%, a specificity of 99.8%, and a positive predictive value of 35%. USS had a sensitivity of 75%, a specificity of 98%, and a positive predictive value of 3%. There were 19 surgeries per case of ovarian cancer in the USS group and 2 surgeries per cancer in the MSS group.

Although the study shows that women will participate in an annual prevalence screening program for ovarian cancer, it's too early to draw conclusions about either strategy's long-term effect, said Dr. Buys, an investigator in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. “Until we have some outcomes data, including data on mortality, we don't really know about the overdiagnosis issue. It … gives us some important information, but as yet we can't say which of the screening techniques—or no screening at all—is better.

Large-scale screening for ovarian cancer with a combination of transvaginal ultrasound and cancer antigen 125 is a feasible strategy that can accurately identify early cancers, a large U.K. trial of almost 203,000 women concluded.

The combination approach carried a sensitivity of 89% and specificity of 99.8% for both primary ovarian and tubal cancers. A comparison strategy that included only transvaginal ultrasound was just as sensitive but significantly less specific, Usha Menon, Ph.D., and colleagues wrote.

Although the two methods detected similar numbers of cancers, the ultrasound-only method identified significantly more borderline ovarian tumors, resulting in almost nine times as many surgeries (845 vs. 97), wrote Dr. Menon, of the University College London, and coauthors (Lancet Oncol. 2009 March 10 [doi:10.1016/S1470–2045(09)70026–9]).

“This highlights an issue that has already become a significant problem in other cancer-screening strategies—the detection of cancers that may never have been diagnosed in an individual's lifetime had [the patients] not been screened,” the investigators noted.

Any cancer screening trial, no matter how impressive, needs to be viewed in light of the overdiagnosis issue, said Dr. Saundra Buys of the University of Utah, Salt Lake City.

“If you have to perform 30 surgeries to cure one cancer, but a patient dies from a surgical complication, you're not really ahead in the game,” she said in an interview. “In this case, we have almost 950 women undergoing surgery with general anesthetic, with all its attendant risks,” to find 87 cancers, 28 of which were borderline tumors. “Some of these would never have caused any health problems had they never been discovered.”

The 4-year U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) comprised 202,638 postmenopausal women (mean age, 60 years). They were randomized to no screening, to annual screening with transvaginal ultrasound, or to annual screening with CA 125 and transvaginal ultrasound as a second-line test.

In the multimodal screening (MMS) group, women with an abnormal CA 125 had either a repeat CA 125 in 12 weeks or an ultrasound in 6 weeks, depending on their other risk factors. On the basis of these results, they could be returned to annual screening or slated for additional testing and clinical assessment.

In the ultrasound-only screening (USS) group, women with abnormal transvaginal ultrasound findings underwent a repeat ultrasound. Depending on these results, they were returned to the screening pool, scheduled for another ultrasound, or referred for clinical assessment.

In the MMS group, 9% of women required a repeat test, and 0.2% underwent surgery. In the USS group, 12% of women required a repeat test and 2% underwent surgery, a ratio of nine surgeries in the USS group for every one in the MSS group.

Of those who underwent surgery, 834 had benign ovarian pathology or normal ovaries, with a significantly higher occurrence in the USS group compared with the MSS group (787 vs. 47). Of these women, 24 (3%) experienced a major surgical complication, with the preponderance again occurring in the USS group (22 vs. 2).

Complications included six perforations of a hollow organ, two excessive hemorrhages requiring additional surgery, one readmission for portal site pain with surgery to remove an endometriotic nodule and residual ovary, one pulmonary embolism, two deep vein thromboses, four wound dehiscences, one wound hematoma, two hernias, one significant case of ileus, one bowel obstruction, one bowel fistula, and two significant infections.

The two screening strategies detected similar numbers of ovarian or tubal malignancies (USS 45, MSS 42). But more borderline tumors were detected in the USS group (20 vs. 8). There was no significant between-group difference in the number of stage II borderline cancers.

For all primary ovarian and tubal cancers, MSS had a sensitivity of 89%, a specificity of 99.8%, and a positive predictive value of 35%. USS had a sensitivity of 75%, a specificity of 98%, and a positive predictive value of 3%. There were 19 surgeries per case of ovarian cancer in the USS group and 2 surgeries per cancer in the MSS group.

Although the study shows that women will participate in an annual prevalence screening program for ovarian cancer, it's too early to draw conclusions about either strategy's long-term effect, said Dr. Buys, an investigator in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. “Until we have some outcomes data, including data on mortality, we don't really know about the overdiagnosis issue. It … gives us some important information, but as yet we can't say which of the screening techniques—or no screening at all—is better.

Large-scale screening for ovarian cancer with a combination of transvaginal ultrasound and cancer antigen 125 is a feasible strategy that can accurately identify early cancers, a large U.K. trial of almost 203,000 women concluded.

The combination approach carried a sensitivity of 89% and specificity of 99.8% for both primary ovarian and tubal cancers. A comparison strategy that included only transvaginal ultrasound was just as sensitive but significantly less specific, Usha Menon, Ph.D., and colleagues wrote.

Although the two methods detected similar numbers of cancers, the ultrasound-only method identified significantly more borderline ovarian tumors, resulting in almost nine times as many surgeries (845 vs. 97), wrote Dr. Menon, of the University College London, and coauthors (Lancet Oncol. 2009 March 10 [doi:10.1016/S1470–2045(09)70026–9]).

“This highlights an issue that has already become a significant problem in other cancer-screening strategies—the detection of cancers that may never have been diagnosed in an individual's lifetime had [the patients] not been screened,” the investigators noted.

Any cancer screening trial, no matter how impressive, needs to be viewed in light of the overdiagnosis issue, said Dr. Saundra Buys of the University of Utah, Salt Lake City.

“If you have to perform 30 surgeries to cure one cancer, but a patient dies from a surgical complication, you're not really ahead in the game,” she said in an interview. “In this case, we have almost 950 women undergoing surgery with general anesthetic, with all its attendant risks,” to find 87 cancers, 28 of which were borderline tumors. “Some of these would never have caused any health problems had they never been discovered.”

The 4-year U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) comprised 202,638 postmenopausal women (mean age, 60 years). They were randomized to no screening, to annual screening with transvaginal ultrasound, or to annual screening with CA 125 and transvaginal ultrasound as a second-line test.

In the multimodal screening (MMS) group, women with an abnormal CA 125 had either a repeat CA 125 in 12 weeks or an ultrasound in 6 weeks, depending on their other risk factors. On the basis of these results, they could be returned to annual screening or slated for additional testing and clinical assessment.

In the ultrasound-only screening (USS) group, women with abnormal transvaginal ultrasound findings underwent a repeat ultrasound. Depending on these results, they were returned to the screening pool, scheduled for another ultrasound, or referred for clinical assessment.

In the MMS group, 9% of women required a repeat test, and 0.2% underwent surgery. In the USS group, 12% of women required a repeat test and 2% underwent surgery, a ratio of nine surgeries in the USS group for every one in the MSS group.

Of those who underwent surgery, 834 had benign ovarian pathology or normal ovaries, with a significantly higher occurrence in the USS group compared with the MSS group (787 vs. 47). Of these women, 24 (3%) experienced a major surgical complication, with the preponderance again occurring in the USS group (22 vs. 2).

Complications included six perforations of a hollow organ, two excessive hemorrhages requiring additional surgery, one readmission for portal site pain with surgery to remove an endometriotic nodule and residual ovary, one pulmonary embolism, two deep vein thromboses, four wound dehiscences, one wound hematoma, two hernias, one significant case of ileus, one bowel obstruction, one bowel fistula, and two significant infections.

The two screening strategies detected similar numbers of ovarian or tubal malignancies (USS 45, MSS 42). But more borderline tumors were detected in the USS group (20 vs. 8). There was no significant between-group difference in the number of stage II borderline cancers.

For all primary ovarian and tubal cancers, MSS had a sensitivity of 89%, a specificity of 99.8%, and a positive predictive value of 35%. USS had a sensitivity of 75%, a specificity of 98%, and a positive predictive value of 3%. There were 19 surgeries per case of ovarian cancer in the USS group and 2 surgeries per cancer in the MSS group.

Although the study shows that women will participate in an annual prevalence screening program for ovarian cancer, it's too early to draw conclusions about either strategy's long-term effect, said Dr. Buys, an investigator in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. “Until we have some outcomes data, including data on mortality, we don't really know about the overdiagnosis issue. It … gives us some important information, but as yet we can't say which of the screening techniques—or no screening at all—is better.

Despite having clinically well-controlled disease, more than half of patients with rheumatoid arthritis experience moderate to severe pain, and few take the medications necessary to control it, according to findings from a prospective study.

Patients and physicians share the responsibility for inadequate pain control, Dr. Mary-Ann Fitzcharles and her colleagues found. Physicians tend to ignore pain in favor of focusing on disease control, whereas patients are afraid of the very medications that could help control pain, wrote Dr. Fitzcharles of McGill University in Montreal (J. Pain 2009;10:300-5).

“Our patients were very, very cautious about pain medication. They are scared of addiction, they dislike taking even more pills, and they worry about drug interactions, side effects, and masking disease progression. … We have not appreciated the importance of pain to these patients and simply don't ask about it,” she said in an interview.

The study comprised 60 patients with RA who attended a specialist rheumatology practice. In all, 54 (90%) were women; their mean age was 57 years. They had been diagnosed with RA for a mean of 14 years. Most (54, or 90%) were taking disease-modifying antirheumatic drugs.

Patients were asked to complete several questionnaires about pain and quality of life. They were also asked about potential barriers to pain control with medications.

A seeming contradiction appeared almost immediately, Dr. Fitzcharles said. Despite 39 (65%) patients' reporting satisfaction with their pain control, 28 (47%) reported a desire for additional pain relief, and 32 (53%) reported experiencing moderate to severe pain. Almost half (45%) reported that the pain caused them moderate to severe distress, and the same percentage reported that pain exerted a moderate to severe interference with their daily activities.

“This was most striking,” she said. “They believed their pain was controlled, yet they were still having pain. And most were not using any modality to reduce the pain. Of the 60 patients, only 4 were taking anything stronger than acetaminophen.”

Patients expressed a high degree of concern about taking pain medications. More than half of the group (55%) expressed at least three barriers to taking such drugs. In all, 48 (80%) were worried about the side effects; 38 (63%) disliked taking even more pills; 34 (57%) worried about drug interactions; 21 (35%) had concerns about addiction; and 16 (27%) thought that controlling pain might mask disease progression. The higher the patient's pain level, the more barriers the patient felt toward controlling that pain.

Patients with RA seem to believe that pain is “an inevitable symptom,” and that little can be done about it, Dr. Fitzcharles and her colleagues wrote. “The importance of pain may also take second place to other effects of RA, including the impact on self-esteem due to deformity, the systemic effects of fatigue and depression, and functional limitations due to mechanical joint dysfunction.”

Physicians, on the other hand, often fail to address the symptom of pain. “Physicians may pay more attention towards the complexities of control of the underlying disease and neglect day-to-day comfort issues for the patient.

Despite having clinically well-controlled disease, more than half of patients with rheumatoid arthritis experience moderate to severe pain, and few take the medications necessary to control it, according to findings from a prospective study.

Patients and physicians share the responsibility for inadequate pain control, Dr. Mary-Ann Fitzcharles and her colleagues found. Physicians tend to ignore pain in favor of focusing on disease control, whereas patients are afraid of the very medications that could help control pain, wrote Dr. Fitzcharles of McGill University in Montreal (J. Pain 2009;10:300-5).

“Our patients were very, very cautious about pain medication. They are scared of addiction, they dislike taking even more pills, and they worry about drug interactions, side effects, and masking disease progression. … We have not appreciated the importance of pain to these patients and simply don't ask about it,” she said in an interview.

The study comprised 60 patients with RA who attended a specialist rheumatology practice. In all, 54 (90%) were women; their mean age was 57 years. They had been diagnosed with RA for a mean of 14 years. Most (54, or 90%) were taking disease-modifying antirheumatic drugs.

Patients were asked to complete several questionnaires about pain and quality of life. They were also asked about potential barriers to pain control with medications.

A seeming contradiction appeared almost immediately, Dr. Fitzcharles said. Despite 39 (65%) patients' reporting satisfaction with their pain control, 28 (47%) reported a desire for additional pain relief, and 32 (53%) reported experiencing moderate to severe pain. Almost half (45%) reported that the pain caused them moderate to severe distress, and the same percentage reported that pain exerted a moderate to severe interference with their daily activities.

“This was most striking,” she said. “They believed their pain was controlled, yet they were still having pain. And most were not using any modality to reduce the pain. Of the 60 patients, only 4 were taking anything stronger than acetaminophen.”

Patients expressed a high degree of concern about taking pain medications. More than half of the group (55%) expressed at least three barriers to taking such drugs. In all, 48 (80%) were worried about the side effects; 38 (63%) disliked taking even more pills; 34 (57%) worried about drug interactions; 21 (35%) had concerns about addiction; and 16 (27%) thought that controlling pain might mask disease progression. The higher the patient's pain level, the more barriers the patient felt toward controlling that pain.

Patients with RA seem to believe that pain is “an inevitable symptom,” and that little can be done about it, Dr. Fitzcharles and her colleagues wrote. “The importance of pain may also take second place to other effects of RA, including the impact on self-esteem due to deformity, the systemic effects of fatigue and depression, and functional limitations due to mechanical joint dysfunction.”

Physicians, on the other hand, often fail to address the symptom of pain. “Physicians may pay more attention towards the complexities of control of the underlying disease and neglect day-to-day comfort issues for the patient.

Despite having clinically well-controlled disease, more than half of patients with rheumatoid arthritis experience moderate to severe pain, and few take the medications necessary to control it, according to findings from a prospective study.

Patients and physicians share the responsibility for inadequate pain control, Dr. Mary-Ann Fitzcharles and her colleagues found. Physicians tend to ignore pain in favor of focusing on disease control, whereas patients are afraid of the very medications that could help control pain, wrote Dr. Fitzcharles of McGill University in Montreal (J. Pain 2009;10:300-5).

“Our patients were very, very cautious about pain medication. They are scared of addiction, they dislike taking even more pills, and they worry about drug interactions, side effects, and masking disease progression. … We have not appreciated the importance of pain to these patients and simply don't ask about it,” she said in an interview.

The study comprised 60 patients with RA who attended a specialist rheumatology practice. In all, 54 (90%) were women; their mean age was 57 years. They had been diagnosed with RA for a mean of 14 years. Most (54, or 90%) were taking disease-modifying antirheumatic drugs.

Patients were asked to complete several questionnaires about pain and quality of life. They were also asked about potential barriers to pain control with medications.

A seeming contradiction appeared almost immediately, Dr. Fitzcharles said. Despite 39 (65%) patients' reporting satisfaction with their pain control, 28 (47%) reported a desire for additional pain relief, and 32 (53%) reported experiencing moderate to severe pain. Almost half (45%) reported that the pain caused them moderate to severe distress, and the same percentage reported that pain exerted a moderate to severe interference with their daily activities.

“This was most striking,” she said. “They believed their pain was controlled, yet they were still having pain. And most were not using any modality to reduce the pain. Of the 60 patients, only 4 were taking anything stronger than acetaminophen.”

Patients expressed a high degree of concern about taking pain medications. More than half of the group (55%) expressed at least three barriers to taking such drugs. In all, 48 (80%) were worried about the side effects; 38 (63%) disliked taking even more pills; 34 (57%) worried about drug interactions; 21 (35%) had concerns about addiction; and 16 (27%) thought that controlling pain might mask disease progression. The higher the patient's pain level, the more barriers the patient felt toward controlling that pain.

Patients with RA seem to believe that pain is “an inevitable symptom,” and that little can be done about it, Dr. Fitzcharles and her colleagues wrote. “The importance of pain may also take second place to other effects of RA, including the impact on self-esteem due to deformity, the systemic effects of fatigue and depression, and functional limitations due to mechanical joint dysfunction.”

Physicians, on the other hand, often fail to address the symptom of pain. “Physicians may pay more attention towards the complexities of control of the underlying disease and neglect day-to-day comfort issues for the patient.

Large-scale screening for ovarian cancer with a combination of transvaginal ultrasound and CA 125 is a feasible strategy that can accurately identify early cancers, a large U.K. trial of almost 203,000 women concluded.

The combination approach carried a sensitivity of 89% and specificity of 99.8% for both primary ovarian and tubal cancers. A comparison strategy that included only transvaginal ultrasound was just as sensitive but significantly less specific, Usha Menon, Ph.D., and colleagues wrote.

Although the two methods detected similar numbers of cancers, the ultrasound-only method identified significantly more borderline ovarian tumors, resulting in almost nine times as many surgeries (845 vs. 97), wrote Dr. Menon of the University College London and the coauthors (Lancet Oncol. 2009 March 10 [doi:10.1016/S1470-2045(09)70026-9

Any cancer screening trial, no matter how impressive, needs to be viewed in light of the overdiagnosis issue, said Dr. Saundra Buys of the University of Utah, Salt Lake City.

“If you have to perform 30 surgeries to cure one cancer, but a patient dies from a surgical complication, you're not really ahead in the game,” she said in an interview. “In this case, we have almost 950 women undergoing surgery with general anesthetic, with all its attendant risks,” to find 87 cancers, 28 of which were borderline tumors.

The 4-year U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) comprised 202,638 postmenopausal women (mean age, 60 years) randomized to no screening, annual screening with transvaginal ultrasound, or annual screening with CA 125 and transvaginal ultrasound as a second-line test.

In the multimodal screening (MMS) group, women with an abnormal CA 125 had either a repeat CA 125 in 12 weeks or an ultrasound in 6 weeks, depending on their other risk factors. Depending on these results, they could be returned to annual screening or slated for additional testing and clinical assessment.

In the ultrasound-only (USS) group, women with an abnormal transvaginal ultrasound screen underwent a repeat ultrasound. Depending on these results, they were returned to the screening pool, scheduled for another ultrasound, or referred for clinical assessment.

In the MMS group, 9% of women required a repeat test, and 0.2% underwent surgery. In the USS group, 12% of women required a repeat test and 2% underwent surgery.

Of those who underwent surgery, 834 had benign ovarian pathology or normal ovaries, with a significantly higher occurrence in the USS group compared with the MSS group (787 vs. 47). Of these women, 24 (3%) experienced a major surgical complication, with most again occurring in the USS group (22 vs. 2).

The two screening strategies detected similar numbers of ovarian or tubal malignancies (USS, 45; MSS, 42). But more borderline tumors were detected in the USS group (20 vs. 8). There was no significant between-group difference in the number of stage II borderline cancers.

For all primary ovarian and tubal cancers, the MSS had a sensitivity of 89%, a specificity of 99.8%, and a positive predictive value of 35%. The USS had a sensitivity of 75%, a specificity of 98%, and a positive predictive value of 3%.

“Until we have some outcomes data, including data on mortality, we don't really know about the overdiagnosis issue. It's a very interesting early look and it gives us some important information, but as yet we can't say which of the screening techniques—or no screening at all—is better,” said Dr. Buys, who is an investigator in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Any cancer screening trial needs to be viewed in light of the overdiagnosis issue. DR. BUYS

Large-scale screening for ovarian cancer with a combination of transvaginal ultrasound and CA 125 is a feasible strategy that can accurately identify early cancers, a large U.K. trial of almost 203,000 women concluded.

The combination approach carried a sensitivity of 89% and specificity of 99.8% for both primary ovarian and tubal cancers. A comparison strategy that included only transvaginal ultrasound was just as sensitive but significantly less specific, Usha Menon, Ph.D., and colleagues wrote.

Although the two methods detected similar numbers of cancers, the ultrasound-only method identified significantly more borderline ovarian tumors, resulting in almost nine times as many surgeries (845 vs. 97), wrote Dr. Menon of the University College London and the coauthors (Lancet Oncol. 2009 March 10 [doi:10.1016/S1470-2045(09)70026-9

Any cancer screening trial, no matter how impressive, needs to be viewed in light of the overdiagnosis issue, said Dr. Saundra Buys of the University of Utah, Salt Lake City.

“If you have to perform 30 surgeries to cure one cancer, but a patient dies from a surgical complication, you're not really ahead in the game,” she said in an interview. “In this case, we have almost 950 women undergoing surgery with general anesthetic, with all its attendant risks,” to find 87 cancers, 28 of which were borderline tumors.

The 4-year U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) comprised 202,638 postmenopausal women (mean age, 60 years) randomized to no screening, annual screening with transvaginal ultrasound, or annual screening with CA 125 and transvaginal ultrasound as a second-line test.

In the multimodal screening (MMS) group, women with an abnormal CA 125 had either a repeat CA 125 in 12 weeks or an ultrasound in 6 weeks, depending on their other risk factors. Depending on these results, they could be returned to annual screening or slated for additional testing and clinical assessment.

In the ultrasound-only (USS) group, women with an abnormal transvaginal ultrasound screen underwent a repeat ultrasound. Depending on these results, they were returned to the screening pool, scheduled for another ultrasound, or referred for clinical assessment.

In the MMS group, 9% of women required a repeat test, and 0.2% underwent surgery. In the USS group, 12% of women required a repeat test and 2% underwent surgery.

Of those who underwent surgery, 834 had benign ovarian pathology or normal ovaries, with a significantly higher occurrence in the USS group compared with the MSS group (787 vs. 47). Of these women, 24 (3%) experienced a major surgical complication, with most again occurring in the USS group (22 vs. 2).

The two screening strategies detected similar numbers of ovarian or tubal malignancies (USS, 45; MSS, 42). But more borderline tumors were detected in the USS group (20 vs. 8). There was no significant between-group difference in the number of stage II borderline cancers.

For all primary ovarian and tubal cancers, the MSS had a sensitivity of 89%, a specificity of 99.8%, and a positive predictive value of 35%. The USS had a sensitivity of 75%, a specificity of 98%, and a positive predictive value of 3%.

“Until we have some outcomes data, including data on mortality, we don't really know about the overdiagnosis issue. It's a very interesting early look and it gives us some important information, but as yet we can't say which of the screening techniques—or no screening at all—is better,” said Dr. Buys, who is an investigator in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Any cancer screening trial needs to be viewed in light of the overdiagnosis issue. DR. BUYS

Large-scale screening for ovarian cancer with a combination of transvaginal ultrasound and CA 125 is a feasible strategy that can accurately identify early cancers, a large U.K. trial of almost 203,000 women concluded.

The combination approach carried a sensitivity of 89% and specificity of 99.8% for both primary ovarian and tubal cancers. A comparison strategy that included only transvaginal ultrasound was just as sensitive but significantly less specific, Usha Menon, Ph.D., and colleagues wrote.

Although the two methods detected similar numbers of cancers, the ultrasound-only method identified significantly more borderline ovarian tumors, resulting in almost nine times as many surgeries (845 vs. 97), wrote Dr. Menon of the University College London and the coauthors (Lancet Oncol. 2009 March 10 [doi:10.1016/S1470-2045(09)70026-9

Any cancer screening trial, no matter how impressive, needs to be viewed in light of the overdiagnosis issue, said Dr. Saundra Buys of the University of Utah, Salt Lake City.

“If you have to perform 30 surgeries to cure one cancer, but a patient dies from a surgical complication, you're not really ahead in the game,” she said in an interview. “In this case, we have almost 950 women undergoing surgery with general anesthetic, with all its attendant risks,” to find 87 cancers, 28 of which were borderline tumors.

The 4-year U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) comprised 202,638 postmenopausal women (mean age, 60 years) randomized to no screening, annual screening with transvaginal ultrasound, or annual screening with CA 125 and transvaginal ultrasound as a second-line test.

In the multimodal screening (MMS) group, women with an abnormal CA 125 had either a repeat CA 125 in 12 weeks or an ultrasound in 6 weeks, depending on their other risk factors. Depending on these results, they could be returned to annual screening or slated for additional testing and clinical assessment.

In the ultrasound-only (USS) group, women with an abnormal transvaginal ultrasound screen underwent a repeat ultrasound. Depending on these results, they were returned to the screening pool, scheduled for another ultrasound, or referred for clinical assessment.

In the MMS group, 9% of women required a repeat test, and 0.2% underwent surgery. In the USS group, 12% of women required a repeat test and 2% underwent surgery.

Of those who underwent surgery, 834 had benign ovarian pathology or normal ovaries, with a significantly higher occurrence in the USS group compared with the MSS group (787 vs. 47). Of these women, 24 (3%) experienced a major surgical complication, with most again occurring in the USS group (22 vs. 2).

The two screening strategies detected similar numbers of ovarian or tubal malignancies (USS, 45; MSS, 42). But more borderline tumors were detected in the USS group (20 vs. 8). There was no significant between-group difference in the number of stage II borderline cancers.

For all primary ovarian and tubal cancers, the MSS had a sensitivity of 89%, a specificity of 99.8%, and a positive predictive value of 35%. The USS had a sensitivity of 75%, a specificity of 98%, and a positive predictive value of 3%.

“Until we have some outcomes data, including data on mortality, we don't really know about the overdiagnosis issue. It's a very interesting early look and it gives us some important information, but as yet we can't say which of the screening techniques—or no screening at all—is better,” said Dr. Buys, who is an investigator in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Any cancer screening trial needs to be viewed in light of the overdiagnosis issue. DR. BUYS

The U.S. Preventive Services Task Force has released the first gender- and age-specific recommendations for aspirin therapy in patients at risk of cardiovascular disease.

Drawing on data from recent studies, the new recommendations conclude that aspirin therapy reduces the risk of heart attack and ischemic stroke in appropriate male candidates, and cuts the risk of ischemic stroke in female candidates. Both groups are at risk of gastrointestinal bleeding.

Daily aspirin therapy therefore should be encouraged in women aged 55–79 years and men aged 45–79 years who have few risks of aspirin-related adverse events and who have potentially large benefits in terms of their respective risk reduction (Ann. Intern. Med. 2009;150:396–410).

The guidelines are the first update to government released recommendations on the topic since 2002.

Seven years ago, “we did not have enough data available to come up with more specific recommendations based on gender,” commented Dr. Michael LeFevre, a member of the task force that wrote the document.

“It was really the Women's Health Study that, when added to other studies, resulted in this very clear distinction in the benefits of aspirin in men and women,” he said.

That study evaluated the risks and benefits of aspirin in the primary prevention of heart disease in almost 40,000 women. It reported a 23% reduction in the risk of ischemic stroke with aspirin use, but no significant benefit for heart attack.

Dr. LeFevre, of the University of Missouri, Columbia, said that the new recommendation is based on an individual risk assessment rather than being an “overarching policy that makes a blanket recommendation.”

The message of individualized risk assessment “is one of the most important pieces of the guidelines,” Dr. LeFevre said in an interview.

“Physicians should look at the risks and potential benefits of aspirin therapy for each individual patient, and recommend it only when the benefit of disease prevention clearly exceeds the risk of adverse effects,” he added.

For men, recognized 10-year coronary heart disease risk factors include age, total and HDL cholesterol levels, blood pressure, and the presence of diabetes and smoking.

Similarly, 10-year stroke risk in women is estimated on the basis of age and the presence of hypertension, diabetes, smoking, history of cardiovascular disease, atrial fibrillation, or left ventricular hypertrophy.

Men and women older than 80 years should receive careful consideration, according to the guidelines. Although the incidence of heart attack and stroke is high in this population, so is the risk of gastrointestinal bleeding. “The net benefit of aspirin use in [these patients] is probably best in those without risk factors for gastrointestinal bleeding (those with normal hemoglobin levels, good kidney function, and easy access to emergency care).”

The risk-benefit ratio should be reassessed every 5 years. The document recommends a daily aspirin dosage of 75 mg.

The USPSTF recommendations differ from those offered by academic societies, including the American College of Cardiology and the American Heart Association, Dr. Christine Laine said in an interview.

Such groups recommend daily aspirin therapy in patients with a high risk of cardiovascular disease or a history of heart attack, but offer no age- or gender-specific recommendations.

“It's not a sea change from the previous guidelines, but it does take advantage of these newer studies to make more definite recommendations, and helps move the decision making from less certain to more certain,” Dr. Laine commented in the interview. She is the senior deputy editor of the Annals of Internal Medicine and a general internist at Jefferson Medical College in Philadelphia.

The U.S. Preventive Services Task Force has released the first gender- and age-specific recommendations for aspirin therapy in patients at risk of cardiovascular disease.

Drawing on data from recent studies, the new recommendations conclude that aspirin therapy reduces the risk of heart attack and ischemic stroke in appropriate male candidates, and cuts the risk of ischemic stroke in female candidates. Both groups are at risk of gastrointestinal bleeding.

Daily aspirin therapy therefore should be encouraged in women aged 55–79 years and men aged 45–79 years who have few risks of aspirin-related adverse events and who have potentially large benefits in terms of their respective risk reduction (Ann. Intern. Med. 2009;150:396–410).

The guidelines are the first update to government released recommendations on the topic since 2002.

Seven years ago, “we did not have enough data available to come up with more specific recommendations based on gender,” commented Dr. Michael LeFevre, a member of the task force that wrote the document.

“It was really the Women's Health Study that, when added to other studies, resulted in this very clear distinction in the benefits of aspirin in men and women,” he said.

That study evaluated the risks and benefits of aspirin in the primary prevention of heart disease in almost 40,000 women. It reported a 23% reduction in the risk of ischemic stroke with aspirin use, but no significant benefit for heart attack.

Dr. LeFevre, of the University of Missouri, Columbia, said that the new recommendation is based on an individual risk assessment rather than being an “overarching policy that makes a blanket recommendation.”

The message of individualized risk assessment “is one of the most important pieces of the guidelines,” Dr. LeFevre said in an interview.

“Physicians should look at the risks and potential benefits of aspirin therapy for each individual patient, and recommend it only when the benefit of disease prevention clearly exceeds the risk of adverse effects,” he added.

For men, recognized 10-year coronary heart disease risk factors include age, total and HDL cholesterol levels, blood pressure, and the presence of diabetes and smoking.

Similarly, 10-year stroke risk in women is estimated on the basis of age and the presence of hypertension, diabetes, smoking, history of cardiovascular disease, atrial fibrillation, or left ventricular hypertrophy.

Men and women older than 80 years should receive careful consideration, according to the guidelines. Although the incidence of heart attack and stroke is high in this population, so is the risk of gastrointestinal bleeding. “The net benefit of aspirin use in [these patients] is probably best in those without risk factors for gastrointestinal bleeding (those with normal hemoglobin levels, good kidney function, and easy access to emergency care).”

The risk-benefit ratio should be reassessed every 5 years. The document recommends a daily aspirin dosage of 75 mg.

The USPSTF recommendations differ from those offered by academic societies, including the American College of Cardiology and the American Heart Association, Dr. Christine Laine said in an interview.

Such groups recommend daily aspirin therapy in patients with a high risk of cardiovascular disease or a history of heart attack, but offer no age- or gender-specific recommendations.

“It's not a sea change from the previous guidelines, but it does take advantage of these newer studies to make more definite recommendations, and helps move the decision making from less certain to more certain,” Dr. Laine commented in the interview. She is the senior deputy editor of the Annals of Internal Medicine and a general internist at Jefferson Medical College in Philadelphia.

The U.S. Preventive Services Task Force has released the first gender- and age-specific recommendations for aspirin therapy in patients at risk of cardiovascular disease.

Drawing on data from recent studies, the new recommendations conclude that aspirin therapy reduces the risk of heart attack and ischemic stroke in appropriate male candidates, and cuts the risk of ischemic stroke in female candidates. Both groups are at risk of gastrointestinal bleeding.

Daily aspirin therapy therefore should be encouraged in women aged 55–79 years and men aged 45–79 years who have few risks of aspirin-related adverse events and who have potentially large benefits in terms of their respective risk reduction (Ann. Intern. Med. 2009;150:396–410).

The guidelines are the first update to government released recommendations on the topic since 2002.

Seven years ago, “we did not have enough data available to come up with more specific recommendations based on gender,” commented Dr. Michael LeFevre, a member of the task force that wrote the document.

“It was really the Women's Health Study that, when added to other studies, resulted in this very clear distinction in the benefits of aspirin in men and women,” he said.

That study evaluated the risks and benefits of aspirin in the primary prevention of heart disease in almost 40,000 women. It reported a 23% reduction in the risk of ischemic stroke with aspirin use, but no significant benefit for heart attack.

Dr. LeFevre, of the University of Missouri, Columbia, said that the new recommendation is based on an individual risk assessment rather than being an “overarching policy that makes a blanket recommendation.”

The message of individualized risk assessment “is one of the most important pieces of the guidelines,” Dr. LeFevre said in an interview.

“Physicians should look at the risks and potential benefits of aspirin therapy for each individual patient, and recommend it only when the benefit of disease prevention clearly exceeds the risk of adverse effects,” he added.

For men, recognized 10-year coronary heart disease risk factors include age, total and HDL cholesterol levels, blood pressure, and the presence of diabetes and smoking.

Similarly, 10-year stroke risk in women is estimated on the basis of age and the presence of hypertension, diabetes, smoking, history of cardiovascular disease, atrial fibrillation, or left ventricular hypertrophy.

Men and women older than 80 years should receive careful consideration, according to the guidelines. Although the incidence of heart attack and stroke is high in this population, so is the risk of gastrointestinal bleeding. “The net benefit of aspirin use in [these patients] is probably best in those without risk factors for gastrointestinal bleeding (those with normal hemoglobin levels, good kidney function, and easy access to emergency care).”

The risk-benefit ratio should be reassessed every 5 years. The document recommends a daily aspirin dosage of 75 mg.

The USPSTF recommendations differ from those offered by academic societies, including the American College of Cardiology and the American Heart Association, Dr. Christine Laine said in an interview.

Such groups recommend daily aspirin therapy in patients with a high risk of cardiovascular disease or a history of heart attack, but offer no age- or gender-specific recommendations.

“It's not a sea change from the previous guidelines, but it does take advantage of these newer studies to make more definite recommendations, and helps move the decision making from less certain to more certain,” Dr. Laine commented in the interview. She is the senior deputy editor of the Annals of Internal Medicine and a general internist at Jefferson Medical College in Philadelphia.

Despite having clinically well-controlled disease, more than half of patients with rheumatoid arthritis experience moderate to severe pain, and few take the medications necessary to control it, according to findings from a prospective study.

Patients and rheumatologists share the responsibility for inadequate pain control, Dr. Mary-Ann Fitzcharles and her colleagues found. Rheumatologists tend to ignore pain in favor of focusing on disease control, whereas patients are afraid of the very medications that could help control pain, wrote Dr. Fitzcharles of McGill University in Montreal (J. Pain 2009;10:300–5).

“Both rheumatologists and patients have been lulled into believing that pain is simply part of the condition,” she said in an interview. “Our patients were very, very cautious about pain medication. They are scared of addiction, they dislike taking even more pills, and they worry about drug interactions, side effects and masking disease progression. We rheumatologists, on the other hand, focus predominately on trying to control the inflammatory disease. We have not appreciated the importance of pain to these patients and simply don't ask about it.”

The study comprised 60 patients with RA who attended a specialist rheumatology practice. In all, 54 (90%) were women; their mean age was 57 years. They had been diagnosed with RA for a mean of 14 years. Most (54, or 90%) were taking disease-modifying antirheumatic drugs.

Patients were asked to complete several questionnaires about pain and quality of life, including the Health Assessment Questionnaire, McGill Pain Questionnaire, and a visual analogue pain scale. They were also asked about potential barriers to pain control with medications.

A seeming contradiction appeared almost immediately, Dr. Fitzcharles said. Despite 39 (65%) patients' reporting satisfaction with their pain control, 28 (47%) reported a desire for additional pain relief, and 32 (53%) reported experiencing moderate to severe pain. Almost half (45%) reported that the pain caused them moderate to severe distress, and the same percentage reported that pain exerted a moderate to severe interference with their daily activities.

“This was most striking,” she said. “They believed their pain was controlled, yet they were still having pain. And most were not using any modality to reduce the pain. Of the 60 patients, only 4 were taking anything stronger than acetaminophen.”

Patients expressed a high degree of concern about taking pain medications. More than half of the group (55%) expressed at least three barriers to taking such drugs. In all, 48 (80%) were worried about the side effects; 38 (63%) disliked taking even more pills; 34 (57%) worried about drug interactions; 21 (35%) had concerns about addiction; and 16 (27%) thought that controlling pain might mask disease progression. The higher the patient's pain level, the more barriers the patient felt toward controlling that pain.

Patients with RA seem to believe that pain is “an inevitable symptom,” and that little can be done about it, Dr. Fitzcharles and her colleagues wrote. “The importance of pain may also take second place to other effects of RA, including the impact on self-esteem due to deformity, the systemic effects of fatigue and depression, and functional limitations due to mechanical joint dysfunction.”

Rheumatologists can—and should—do more to investigate pain in their RA patients, the authors said. Patients should be specifically questioned about pain, because many will not volunteer this information. It's also a good idea to explore their worries about pain medication.

Despite having clinically well-controlled disease, more than half of patients with rheumatoid arthritis experience moderate to severe pain, and few take the medications necessary to control it, according to findings from a prospective study.

Patients and rheumatologists share the responsibility for inadequate pain control, Dr. Mary-Ann Fitzcharles and her colleagues found. Rheumatologists tend to ignore pain in favor of focusing on disease control, whereas patients are afraid of the very medications that could help control pain, wrote Dr. Fitzcharles of McGill University in Montreal (J. Pain 2009;10:300–5).

“Both rheumatologists and patients have been lulled into believing that pain is simply part of the condition,” she said in an interview. “Our patients were very, very cautious about pain medication. They are scared of addiction, they dislike taking even more pills, and they worry about drug interactions, side effects and masking disease progression. We rheumatologists, on the other hand, focus predominately on trying to control the inflammatory disease. We have not appreciated the importance of pain to these patients and simply don't ask about it.”

The study comprised 60 patients with RA who attended a specialist rheumatology practice. In all, 54 (90%) were women; their mean age was 57 years. They had been diagnosed with RA for a mean of 14 years. Most (54, or 90%) were taking disease-modifying antirheumatic drugs.

Patients were asked to complete several questionnaires about pain and quality of life, including the Health Assessment Questionnaire, McGill Pain Questionnaire, and a visual analogue pain scale. They were also asked about potential barriers to pain control with medications.

A seeming contradiction appeared almost immediately, Dr. Fitzcharles said. Despite 39 (65%) patients' reporting satisfaction with their pain control, 28 (47%) reported a desire for additional pain relief, and 32 (53%) reported experiencing moderate to severe pain. Almost half (45%) reported that the pain caused them moderate to severe distress, and the same percentage reported that pain exerted a moderate to severe interference with their daily activities.

“This was most striking,” she said. “They believed their pain was controlled, yet they were still having pain. And most were not using any modality to reduce the pain. Of the 60 patients, only 4 were taking anything stronger than acetaminophen.”

Patients expressed a high degree of concern about taking pain medications. More than half of the group (55%) expressed at least three barriers to taking such drugs. In all, 48 (80%) were worried about the side effects; 38 (63%) disliked taking even more pills; 34 (57%) worried about drug interactions; 21 (35%) had concerns about addiction; and 16 (27%) thought that controlling pain might mask disease progression. The higher the patient's pain level, the more barriers the patient felt toward controlling that pain.

Patients with RA seem to believe that pain is “an inevitable symptom,” and that little can be done about it, Dr. Fitzcharles and her colleagues wrote. “The importance of pain may also take second place to other effects of RA, including the impact on self-esteem due to deformity, the systemic effects of fatigue and depression, and functional limitations due to mechanical joint dysfunction.”

Rheumatologists can—and should—do more to investigate pain in their RA patients, the authors said. Patients should be specifically questioned about pain, because many will not volunteer this information. It's also a good idea to explore their worries about pain medication.

Despite having clinically well-controlled disease, more than half of patients with rheumatoid arthritis experience moderate to severe pain, and few take the medications necessary to control it, according to findings from a prospective study.

Patients and rheumatologists share the responsibility for inadequate pain control, Dr. Mary-Ann Fitzcharles and her colleagues found. Rheumatologists tend to ignore pain in favor of focusing on disease control, whereas patients are afraid of the very medications that could help control pain, wrote Dr. Fitzcharles of McGill University in Montreal (J. Pain 2009;10:300–5).

“Both rheumatologists and patients have been lulled into believing that pain is simply part of the condition,” she said in an interview. “Our patients were very, very cautious about pain medication. They are scared of addiction, they dislike taking even more pills, and they worry about drug interactions, side effects and masking disease progression. We rheumatologists, on the other hand, focus predominately on trying to control the inflammatory disease. We have not appreciated the importance of pain to these patients and simply don't ask about it.”

The study comprised 60 patients with RA who attended a specialist rheumatology practice. In all, 54 (90%) were women; their mean age was 57 years. They had been diagnosed with RA for a mean of 14 years. Most (54, or 90%) were taking disease-modifying antirheumatic drugs.

Patients were asked to complete several questionnaires about pain and quality of life, including the Health Assessment Questionnaire, McGill Pain Questionnaire, and a visual analogue pain scale. They were also asked about potential barriers to pain control with medications.

A seeming contradiction appeared almost immediately, Dr. Fitzcharles said. Despite 39 (65%) patients' reporting satisfaction with their pain control, 28 (47%) reported a desire for additional pain relief, and 32 (53%) reported experiencing moderate to severe pain. Almost half (45%) reported that the pain caused them moderate to severe distress, and the same percentage reported that pain exerted a moderate to severe interference with their daily activities.

“This was most striking,” she said. “They believed their pain was controlled, yet they were still having pain. And most were not using any modality to reduce the pain. Of the 60 patients, only 4 were taking anything stronger than acetaminophen.”

Patients expressed a high degree of concern about taking pain medications. More than half of the group (55%) expressed at least three barriers to taking such drugs. In all, 48 (80%) were worried about the side effects; 38 (63%) disliked taking even more pills; 34 (57%) worried about drug interactions; 21 (35%) had concerns about addiction; and 16 (27%) thought that controlling pain might mask disease progression. The higher the patient's pain level, the more barriers the patient felt toward controlling that pain.

Patients with RA seem to believe that pain is “an inevitable symptom,” and that little can be done about it, Dr. Fitzcharles and her colleagues wrote. “The importance of pain may also take second place to other effects of RA, including the impact on self-esteem due to deformity, the systemic effects of fatigue and depression, and functional limitations due to mechanical joint dysfunction.”

Rheumatologists can—and should—do more to investigate pain in their RA patients, the authors said. Patients should be specifically questioned about pain, because many will not volunteer this information. It's also a good idea to explore their worries about pain medication.

NASHVILLE, TENN. — Heliox may have a beneficial effect when used to deliver racemic epinephrine to young children with bronchiolitis, suggest the results of a randomized controlled trial.

Investigators found that children treated with epinephrine and heliox improved significantly more than those treated with epinephrine and oxygen, Dr. In Kim reported in a poster presented at the annual congress of the Society of Critical Care Medicine.

“The mixture of helium and oxygen delivers nebulization deeper and faster into the lungs and has been shown to ease the work of breathing in adults,” Dr. Kim, a pediatric emergency physician at Kosair Children's Hospital in Louisville, Ky., said in an interview. “This would also be very important for these little ones, in whom more work of breathing can lead to fatigue and even respiratory failure.”

The study involved 69 children aged 2–12 months, all of whom still had a Modified Wood's Clinical Asthma Score of at least 3 after an initial treatment of nebulized albuterol. The patients were randomized to nebulized racemic epinephrine delivered either by heliox (70% helium/30% oxygen) or 100% oxygen using a face mask. After the nebulization, all patients continued receiving their randomized treatment via a nasal cannula, which Dr. Kim said is more tolerable than a face mask for young children.

After 60 minutes of treatment, children whose bronchiolitis scores were 2 or higher received another dose of the nebulized racemic epinephrine, followed by continued inhalation via nasal cannula.

By 60 minutes, children receiving the drug via heliox had improved significantly more than those receiving the drug by oxygen. “The difference was significant early on and continued to grow,” said Dr. Kim. By 240 minutes or at ED discharge, the mean change in the bronchiolitis score was 1.84 for the heliox group and 0.31 for the oxygen group—a highly statistically significant finding.

The findings almost exactly mirror those of a similar trial conducted in Spain in 2002. “We did not have a difference in length of stay, as the Spanish study did, but it also included sicker patients than ours. This supports the theory that the sicker the patient is, the greater the benefit of heliox,” Dr. Kim said.

The Spanish study included 38 young children and infants aged 1–24 months who were admitted to the pediatric intensive care unit with respiratory syncytial virus bronchiolitis (Pediatrics 2002;109:68–73). Those randomized to nebulizer and inhalation therapy with heliox had a significantly larger mean decrease in bronchiolitis scores since the beginning of the study (4.2 points), than did children in the oxygen group (2.5 points). Pediatric intensive care unit length of stay was significantly shorter in the heliox group than in the oxygen group (3.5 days vs. 5 days).

Dr. Kim did not disclose any financial conflicts.

NASHVILLE, TENN. — Heliox may have a beneficial effect when used to deliver racemic epinephrine to young children with bronchiolitis, suggest the results of a randomized controlled trial.

Investigators found that children treated with epinephrine and heliox improved significantly more than those treated with epinephrine and oxygen, Dr. In Kim reported in a poster presented at the annual congress of the Society of Critical Care Medicine.

“The mixture of helium and oxygen delivers nebulization deeper and faster into the lungs and has been shown to ease the work of breathing in adults,” Dr. Kim, a pediatric emergency physician at Kosair Children's Hospital in Louisville, Ky., said in an interview. “This would also be very important for these little ones, in whom more work of breathing can lead to fatigue and even respiratory failure.”

The study involved 69 children aged 2–12 months, all of whom still had a Modified Wood's Clinical Asthma Score of at least 3 after an initial treatment of nebulized albuterol. The patients were randomized to nebulized racemic epinephrine delivered either by heliox (70% helium/30% oxygen) or 100% oxygen using a face mask. After the nebulization, all patients continued receiving their randomized treatment via a nasal cannula, which Dr. Kim said is more tolerable than a face mask for young children.

After 60 minutes of treatment, children whose bronchiolitis scores were 2 or higher received another dose of the nebulized racemic epinephrine, followed by continued inhalation via nasal cannula.

By 60 minutes, children receiving the drug via heliox had improved significantly more than those receiving the drug by oxygen. “The difference was significant early on and continued to grow,” said Dr. Kim. By 240 minutes or at ED discharge, the mean change in the bronchiolitis score was 1.84 for the heliox group and 0.31 for the oxygen group—a highly statistically significant finding.

The findings almost exactly mirror those of a similar trial conducted in Spain in 2002. “We did not have a difference in length of stay, as the Spanish study did, but it also included sicker patients than ours. This supports the theory that the sicker the patient is, the greater the benefit of heliox,” Dr. Kim said.

The Spanish study included 38 young children and infants aged 1–24 months who were admitted to the pediatric intensive care unit with respiratory syncytial virus bronchiolitis (Pediatrics 2002;109:68–73). Those randomized to nebulizer and inhalation therapy with heliox had a significantly larger mean decrease in bronchiolitis scores since the beginning of the study (4.2 points), than did children in the oxygen group (2.5 points). Pediatric intensive care unit length of stay was significantly shorter in the heliox group than in the oxygen group (3.5 days vs. 5 days).

Dr. Kim did not disclose any financial conflicts.

NASHVILLE, TENN. — Heliox may have a beneficial effect when used to deliver racemic epinephrine to young children with bronchiolitis, suggest the results of a randomized controlled trial.

Investigators found that children treated with epinephrine and heliox improved significantly more than those treated with epinephrine and oxygen, Dr. In Kim reported in a poster presented at the annual congress of the Society of Critical Care Medicine.

“The mixture of helium and oxygen delivers nebulization deeper and faster into the lungs and has been shown to ease the work of breathing in adults,” Dr. Kim, a pediatric emergency physician at Kosair Children's Hospital in Louisville, Ky., said in an interview. “This would also be very important for these little ones, in whom more work of breathing can lead to fatigue and even respiratory failure.”

The study involved 69 children aged 2–12 months, all of whom still had a Modified Wood's Clinical Asthma Score of at least 3 after an initial treatment of nebulized albuterol. The patients were randomized to nebulized racemic epinephrine delivered either by heliox (70% helium/30% oxygen) or 100% oxygen using a face mask. After the nebulization, all patients continued receiving their randomized treatment via a nasal cannula, which Dr. Kim said is more tolerable than a face mask for young children.

After 60 minutes of treatment, children whose bronchiolitis scores were 2 or higher received another dose of the nebulized racemic epinephrine, followed by continued inhalation via nasal cannula.

By 60 minutes, children receiving the drug via heliox had improved significantly more than those receiving the drug by oxygen. “The difference was significant early on and continued to grow,” said Dr. Kim. By 240 minutes or at ED discharge, the mean change in the bronchiolitis score was 1.84 for the heliox group and 0.31 for the oxygen group—a highly statistically significant finding.

The findings almost exactly mirror those of a similar trial conducted in Spain in 2002. “We did not have a difference in length of stay, as the Spanish study did, but it also included sicker patients than ours. This supports the theory that the sicker the patient is, the greater the benefit of heliox,” Dr. Kim said.

The Spanish study included 38 young children and infants aged 1–24 months who were admitted to the pediatric intensive care unit with respiratory syncytial virus bronchiolitis (Pediatrics 2002;109:68–73). Those randomized to nebulizer and inhalation therapy with heliox had a significantly larger mean decrease in bronchiolitis scores since the beginning of the study (4.2 points), than did children in the oxygen group (2.5 points). Pediatric intensive care unit length of stay was significantly shorter in the heliox group than in the oxygen group (3.5 days vs. 5 days).

Dr. Kim did not disclose any financial conflicts.

Two large prostate cancer screening trials led to different conclusions about the disease's impact on mortality: One found that screening reduces prostate cancer deaths by 20%, and the other found that it makes no difference at all.

The results were published online to coincide with a press briefing at the European Association of Urology Annual Congress in Stockholm.

The Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial followed 77,000 men for up to 10 years and found similar rates of prostate cancer death among those randomized to regular screening with prostate-specific antigen (PSA) testing or to usual care (50 vs. 44 deaths).

Conversely, the European Randomized Study of Screening for Prostate Cancer (ERSPC), which included 182,000 men, found that routine PSA screening significantly reduced the rate of prostate cancer mortality, compared with usual care. But the savings come at a price, admitted primary investigator Dr. Fritz Schroder and his colleagues: More than 1,400 men would need to be screened and 48 additional cancers treated to save one life.

After reading the two studies, physicians and patients may be as confused as ever about balancing the risks of long-standing adverse treatment effects with the benefits of early diagnosis and treatment, Dr. Philip W. Kantoff said in a discussion sponsored by the New England Journal of Medicine.

“The deceptively simple PSA test inevitably leads to a cascade of biopsies, which lead to prostate-cancer diagnoses, leading to aggressive treatments for those prostate cancers, leading to men having substantial side effects from those treatments [including] urinary incontinence and sexual dysfunction,” said Dr. Kantoff, director of the Lank Center for Genitourinary Oncology at the Dana Farber Cancer Institute, Boston.

“And many of these men suffer those downstream troubles for a cancer that was never, ever destined to cause them harm in their lifetime,” he noted.

Dr. Michael J. Barry, who wrote an editorial that accompanied the papers, concurred. “The trade-offs reflected in these data, like beauty, will be in the eye of the beholder,” wrote Dr. Barry of Massachusetts General Hospital, Boston.

“Some well-informed clinicians and patients will still see those trade-offs as favorable, others will see them as unfavorable. As a result, a shared decision-making approach to PSA screening, as recommended by most guidelines, seems more appropriate than ever” (N. Engl. J. Med. 2009;360:1351–4).

From 1993–2001, PLCO randomized 77,000 men aged 55–74 years to either annual screening (PSA testing for 6 years and digital rectal exam for 4 years) or usual care, which sometimes included screening. The PSA cutoff for biopsy was 4 ng/mL.

Dr. Gerald Andriole and his colleagues reported outcomes after 7 and 10 years of follow-up (N. Engl. J. Med. 2009;360:1310–9). At 7 years, prostate cancer had been diagnosed in 2,820 in the screening group and 2,322 in the control group, a significant difference. At 10 years, there were still significantly more cancers diagnosed in the screening group (3,452 vs. 2,974).

At 7 years, 50 men had died from prostate cancer in the screening group and 44 in the control group—a nonsignificant 13% difference. By year 10, with data in for 67% of the subjects, 92 in the screening group and 82 in the control group had died—also a nonsignificant difference. The difference stayed nonsignificant when the data were analyzed by tumor stage or previous screening at baseline.

Although treatment-related complications arose, those data were not included. Instead, they are being analyzed as part of an upcoming quality of life study.

The authors noted that the lack of mortality reduction could be caused by improved prostate cancer treatment over the trial period or by the short follow-up time, which might not have been enough for all cancers to develop. “However,” wrote Dr. Andriole of Washington University, St. Louis, “We now know that prostate-cancer screening provides no reduction in death rates at 7 years and no indication of a benefit … by 10 years.”

ERSPC examined outcomes in 162,000 men aged 50–74 years who had been included in seven European health registries, wrote Dr. Schroder of Erasmus Medical Center, Rotterdam. Subjects were randomized to PSA screening once every 4 years or to no regular screening. The screening protocol varied by country; PSA cutoffs triggering more investigation ranged from 2.5–4 ng/mL (N. Engl. J. Med. 2009;360:1320–8).

Overall, screening nearly doubled the number of prostate cancers diagnosed (5,990 in the screening group vs. 4,307 in the control group). But the increased diagnoses carried a price. Of those who underwent biopsy for an elevated PSA, 76% had a false-positive result. The positive predictive value of a biopsy was also low—just 24% on average.

In a preselected core group of men aged 55–69 years, there were significantly more prostate-cancer deaths in the control group (326 vs. 214; odds ratio 0.80). In the intent-to-screen analysis, which included all subjects, the absolute difference between the screening and control groups was 0.71 deaths per 1,000 men, yielding 1,410 screenings and 48 cancers to prevent one prostate cancer death.

The study did not report data on cost effectiveness, adverse treatment effects or quality of life issues. “The ratio of benefits to risks that is achievable with more frequent screening or a lower PSA threshold than we used remains unknown,” the authors wrote.

More than 1,400 men would need to be screened and 48 additional cancers treated to save one life. DR. SCHRODER

Two large prostate cancer screening trials led to different conclusions about the disease's impact on mortality: One found that screening reduces prostate cancer deaths by 20%, and the other found that it makes no difference at all.

The results were published online to coincide with a press briefing at the European Association of Urology Annual Congress in Stockholm.

The Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial followed 77,000 men for up to 10 years and found similar rates of prostate cancer death among those randomized to regular screening with prostate-specific antigen (PSA) testing or to usual care (50 vs. 44 deaths).

Conversely, the European Randomized Study of Screening for Prostate Cancer (ERSPC), which included 182,000 men, found that routine PSA screening significantly reduced the rate of prostate cancer mortality, compared with usual care. But the savings come at a price, admitted primary investigator Dr. Fritz Schroder and his colleagues: More than 1,400 men would need to be screened and 48 additional cancers treated to save one life.

After reading the two studies, physicians and patients may be as confused as ever about balancing the risks of long-standing adverse treatment effects with the benefits of early diagnosis and treatment, Dr. Philip W. Kantoff said in a discussion sponsored by the New England Journal of Medicine.

“The deceptively simple PSA test inevitably leads to a cascade of biopsies, which lead to prostate-cancer diagnoses, leading to aggressive treatments for those prostate cancers, leading to men having substantial side effects from those treatments [including] urinary incontinence and sexual dysfunction,” said Dr. Kantoff, director of the Lank Center for Genitourinary Oncology at the Dana Farber Cancer Institute, Boston.

“And many of these men suffer those downstream troubles for a cancer that was never, ever destined to cause them harm in their lifetime,” he noted.

Dr. Michael J. Barry, who wrote an editorial that accompanied the papers, concurred. “The trade-offs reflected in these data, like beauty, will be in the eye of the beholder,” wrote Dr. Barry of Massachusetts General Hospital, Boston.

“Some well-informed clinicians and patients will still see those trade-offs as favorable, others will see them as unfavorable. As a result, a shared decision-making approach to PSA screening, as recommended by most guidelines, seems more appropriate than ever” (N. Engl. J. Med. 2009;360:1351–4).

From 1993–2001, PLCO randomized 77,000 men aged 55–74 years to either annual screening (PSA testing for 6 years and digital rectal exam for 4 years) or usual care, which sometimes included screening. The PSA cutoff for biopsy was 4 ng/mL.

Dr. Gerald Andriole and his colleagues reported outcomes after 7 and 10 years of follow-up (N. Engl. J. Med. 2009;360:1310–9). At 7 years, prostate cancer had been diagnosed in 2,820 in the screening group and 2,322 in the control group, a significant difference. At 10 years, there were still significantly more cancers diagnosed in the screening group (3,452 vs. 2,974).

At 7 years, 50 men had died from prostate cancer in the screening group and 44 in the control group—a nonsignificant 13% difference. By year 10, with data in for 67% of the subjects, 92 in the screening group and 82 in the control group had died—also a nonsignificant difference. The difference stayed nonsignificant when the data were analyzed by tumor stage or previous screening at baseline.

Although treatment-related complications arose, those data were not included. Instead, they are being analyzed as part of an upcoming quality of life study.

The authors noted that the lack of mortality reduction could be caused by improved prostate cancer treatment over the trial period or by the short follow-up time, which might not have been enough for all cancers to develop. “However,” wrote Dr. Andriole of Washington University, St. Louis, “We now know that prostate-cancer screening provides no reduction in death rates at 7 years and no indication of a benefit … by 10 years.”

ERSPC examined outcomes in 162,000 men aged 50–74 years who had been included in seven European health registries, wrote Dr. Schroder of Erasmus Medical Center, Rotterdam. Subjects were randomized to PSA screening once every 4 years or to no regular screening. The screening protocol varied by country; PSA cutoffs triggering more investigation ranged from 2.5–4 ng/mL (N. Engl. J. Med. 2009;360:1320–8).

Overall, screening nearly doubled the number of prostate cancers diagnosed (5,990 in the screening group vs. 4,307 in the control group). But the increased diagnoses carried a price. Of those who underwent biopsy for an elevated PSA, 76% had a false-positive result. The positive predictive value of a biopsy was also low—just 24% on average.

In a preselected core group of men aged 55–69 years, there were significantly more prostate-cancer deaths in the control group (326 vs. 214; odds ratio 0.80). In the intent-to-screen analysis, which included all subjects, the absolute difference between the screening and control groups was 0.71 deaths per 1,000 men, yielding 1,410 screenings and 48 cancers to prevent one prostate cancer death.

The study did not report data on cost effectiveness, adverse treatment effects or quality of life issues. “The ratio of benefits to risks that is achievable with more frequent screening or a lower PSA threshold than we used remains unknown,” the authors wrote.

More than 1,400 men would need to be screened and 48 additional cancers treated to save one life. DR. SCHRODER

Two large prostate cancer screening trials led to different conclusions about the disease's impact on mortality: One found that screening reduces prostate cancer deaths by 20%, and the other found that it makes no difference at all.

The results were published online to coincide with a press briefing at the European Association of Urology Annual Congress in Stockholm.

The Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial followed 77,000 men for up to 10 years and found similar rates of prostate cancer death among those randomized to regular screening with prostate-specific antigen (PSA) testing or to usual care (50 vs. 44 deaths).

Conversely, the European Randomized Study of Screening for Prostate Cancer (ERSPC), which included 182,000 men, found that routine PSA screening significantly reduced the rate of prostate cancer mortality, compared with usual care. But the savings come at a price, admitted primary investigator Dr. Fritz Schroder and his colleagues: More than 1,400 men would need to be screened and 48 additional cancers treated to save one life.

After reading the two studies, physicians and patients may be as confused as ever about balancing the risks of long-standing adverse treatment effects with the benefits of early diagnosis and treatment, Dr. Philip W. Kantoff said in a discussion sponsored by the New England Journal of Medicine.

“The deceptively simple PSA test inevitably leads to a cascade of biopsies, which lead to prostate-cancer diagnoses, leading to aggressive treatments for those prostate cancers, leading to men having substantial side effects from those treatments [including] urinary incontinence and sexual dysfunction,” said Dr. Kantoff, director of the Lank Center for Genitourinary Oncology at the Dana Farber Cancer Institute, Boston.

“And many of these men suffer those downstream troubles for a cancer that was never, ever destined to cause them harm in their lifetime,” he noted.

Dr. Michael J. Barry, who wrote an editorial that accompanied the papers, concurred. “The trade-offs reflected in these data, like beauty, will be in the eye of the beholder,” wrote Dr. Barry of Massachusetts General Hospital, Boston.

“Some well-informed clinicians and patients will still see those trade-offs as favorable, others will see them as unfavorable. As a result, a shared decision-making approach to PSA screening, as recommended by most guidelines, seems more appropriate than ever” (N. Engl. J. Med. 2009;360:1351–4).

From 1993–2001, PLCO randomized 77,000 men aged 55–74 years to either annual screening (PSA testing for 6 years and digital rectal exam for 4 years) or usual care, which sometimes included screening. The PSA cutoff for biopsy was 4 ng/mL.

Dr. Gerald Andriole and his colleagues reported outcomes after 7 and 10 years of follow-up (N. Engl. J. Med. 2009;360:1310–9). At 7 years, prostate cancer had been diagnosed in 2,820 in the screening group and 2,322 in the control group, a significant difference. At 10 years, there were still significantly more cancers diagnosed in the screening group (3,452 vs. 2,974).

At 7 years, 50 men had died from prostate cancer in the screening group and 44 in the control group—a nonsignificant 13% difference. By year 10, with data in for 67% of the subjects, 92 in the screening group and 82 in the control group had died—also a nonsignificant difference. The difference stayed nonsignificant when the data were analyzed by tumor stage or previous screening at baseline.

Although treatment-related complications arose, those data were not included. Instead, they are being analyzed as part of an upcoming quality of life study.

The authors noted that the lack of mortality reduction could be caused by improved prostate cancer treatment over the trial period or by the short follow-up time, which might not have been enough for all cancers to develop. “However,” wrote Dr. Andriole of Washington University, St. Louis, “We now know that prostate-cancer screening provides no reduction in death rates at 7 years and no indication of a benefit … by 10 years.”

ERSPC examined outcomes in 162,000 men aged 50–74 years who had been included in seven European health registries, wrote Dr. Schroder of Erasmus Medical Center, Rotterdam. Subjects were randomized to PSA screening once every 4 years or to no regular screening. The screening protocol varied by country; PSA cutoffs triggering more investigation ranged from 2.5–4 ng/mL (N. Engl. J. Med. 2009;360:1320–8).

Overall, screening nearly doubled the number of prostate cancers diagnosed (5,990 in the screening group vs. 4,307 in the control group). But the increased diagnoses carried a price. Of those who underwent biopsy for an elevated PSA, 76% had a false-positive result. The positive predictive value of a biopsy was also low—just 24% on average.

In a preselected core group of men aged 55–69 years, there were significantly more prostate-cancer deaths in the control group (326 vs. 214; odds ratio 0.80). In the intent-to-screen analysis, which included all subjects, the absolute difference between the screening and control groups was 0.71 deaths per 1,000 men, yielding 1,410 screenings and 48 cancers to prevent one prostate cancer death.

The study did not report data on cost effectiveness, adverse treatment effects or quality of life issues. “The ratio of benefits to risks that is achievable with more frequent screening or a lower PSA threshold than we used remains unknown,” the authors wrote.

More than 1,400 men would need to be screened and 48 additional cancers treated to save one life. DR. SCHRODER

Pertussis vaccination in infancy doesn't appear to increase the risk of wheezing or asthma during childhood and, in fact, may be slightly protective against the disorders, a large population-based study concluded.

The analysis by Ben D. Spycher, a researcher at the University of Bern (Switzerland) and his colleagues, was based on data from Britain's National Health Service and from a large respiratory cohort study. It compared rates of new-onset wheeze and asthma occurring after 4 months of age with pertussis vaccinations in 6,048 children who were followed for up to 10 years (Pediatrics 2009;123:944–50).

There were 2,426 cases of new-onset wheeze in the group. In both time frames, the univariate analysis showed that children who were fully vaccinated were slightly, but not significantly, less likely to develop wheezing. The slight, nonsignificant, protective factor remained for both time frames in the multivariate analysis.

The outcomes were similar for diagnosed asthma, the authors noted. A sensitivity analysis suggested that exposure to other vaccines administered concurrently yielded similar results. The work was supported by national grants from Switzerland and the United Kingdom. The authors declared no conflicts.

Pertussis vaccination in infancy doesn't appear to increase the risk of wheezing or asthma during childhood and, in fact, may be slightly protective against the disorders, a large population-based study concluded.

The analysis by Ben D. Spycher, a researcher at the University of Bern (Switzerland) and his colleagues, was based on data from Britain's National Health Service and from a large respiratory cohort study. It compared rates of new-onset wheeze and asthma occurring after 4 months of age with pertussis vaccinations in 6,048 children who were followed for up to 10 years (Pediatrics 2009;123:944–50).

There were 2,426 cases of new-onset wheeze in the group. In both time frames, the univariate analysis showed that children who were fully vaccinated were slightly, but not significantly, less likely to develop wheezing. The slight, nonsignificant, protective factor remained for both time frames in the multivariate analysis.

The outcomes were similar for diagnosed asthma, the authors noted. A sensitivity analysis suggested that exposure to other vaccines administered concurrently yielded similar results. The work was supported by national grants from Switzerland and the United Kingdom. The authors declared no conflicts.

Pertussis vaccination in infancy doesn't appear to increase the risk of wheezing or asthma during childhood and, in fact, may be slightly protective against the disorders, a large population-based study concluded.

The analysis by Ben D. Spycher, a researcher at the University of Bern (Switzerland) and his colleagues, was based on data from Britain's National Health Service and from a large respiratory cohort study. It compared rates of new-onset wheeze and asthma occurring after 4 months of age with pertussis vaccinations in 6,048 children who were followed for up to 10 years (Pediatrics 2009;123:944–50).

There were 2,426 cases of new-onset wheeze in the group. In both time frames, the univariate analysis showed that children who were fully vaccinated were slightly, but not significantly, less likely to develop wheezing. The slight, nonsignificant, protective factor remained for both time frames in the multivariate analysis.

The outcomes were similar for diagnosed asthma, the authors noted. A sensitivity analysis suggested that exposure to other vaccines administered concurrently yielded similar results. The work was supported by national grants from Switzerland and the United Kingdom. The authors declared no conflicts.

The U.S. Preventive Services Task Force has released the first gender- and age-specific recommendations for aspirin therapy in patients at risk of cardiovascular disease.

Drawing on data from recent studies, the new recommendations conclude that aspirin therapy reduces the risk of heart attack and ischemic stroke in appropriate male candidates, while it cuts the risk of ischemic stroke in female candidates. Both groups are at risk of gastrointestinal bleeding. Daily aspirin therapy therefore should be encouraged in women aged 55–79 years and men aged 45–79 years who have few risks of aspirin-related adverse events and who have potentially large benefits in terms of their respective risk reduction (Ann. Intern. Med. 2009;150:396–410).

The guidelines are the first update to government released recommendations on the topic since 2002.

Seven years ago, “we did not have enough data available to come up with more specific recommendations based on gender,” said Dr. Michael LeFevre, a member of the task force that wrote the document. “It was really the Women's Health Study that, when added to other studies, resulted in this very clear distinction in the benefits of aspirin in men and women.”

That study evaluated the risks and benefits of aspirin in the primary prevention of heart disease in almost 40,000 women. It reported a 23% reduction in the risk of ischemic stroke with aspirin use, but no significant benefit for heart attack.

Dr. LeFevre, a professor of family medicine at the University of Missouri, Columbia, said that the recommendations are based on an individual's risk.

For men, 10-year coronary heart disease risk factors include age, total and high-density lipoprotein cholesterol levels, blood pressure, and the presence of diabetes and smoking. Similarly, 10-year stroke risk in women is estimated on the basis of age, and the presence of hypertension, diabetes, smoking, history of cardiovascular disease, atrial fibrillation, or left ventricular hypertrophy.

Men and women older than 80 years should receive careful consideration, according to the guidelines. Although the incidence of heart attack and stroke is high in this population, so is the risk of gastrointestinal bleeding. “The net benefit of aspirin use in [these patients] is probably best in those without risk factors for gastrointestinal bleeding (those with normal hemoglobin levels, good kidney function, and easy access to emergency care).”

The risk/benefit ratio should be reassessed every 5 years. The document recommends a daily aspirin dosage of 75 mg.

The USPTF recommendations differ from those offered by academic societies, including the American College of Cardiology and the American Heart Association, Dr. Christine Laine said in an interview. Such groups recommend daily aspirin therapy in patients with a high risk of cardiovascular disease or a history of heart attack, but offer no age- or gender-specific recommendations.

“It's not a sea change from the previous guidelines, but it does take advantage of these newer studies to make more definite recommendations, and helps move the decision making from less certain to more certain,” said Dr. Laine, the senior deputy editor of the Annals of Internal Medicine and a general internist at Jefferson Medical College, Philadelphia.

The recommendations “set a new standard for guidelines,” said family physician Peter P. Toth. “There is a simplicity to the recommendations, yet the data supporting them were rigorously analyzed and appropriately interpreted,” said the director of preventive cardiology at the Sterling Rock Falls Clinic in Sterling, Ill.

Because the recommendations don't require a Framingham risk calculation, they will be much more appealing to busy primary care physicians, he said in an interview. Calculating the Framingham score “was strongly recommended by National Cholesterol Education Program Guidelines in patients with two or more risk factors. However, virtually no one does it, whether they practice in an academic or community-based setting, because it is perceived to be cumbersome and time-consuming.

The U.S. Preventive Services Task Force has released the first gender- and age-specific recommendations for aspirin therapy in patients at risk of cardiovascular disease.

Drawing on data from recent studies, the new recommendations conclude that aspirin therapy reduces the risk of heart attack and ischemic stroke in appropriate male candidates, while it cuts the risk of ischemic stroke in female candidates. Both groups are at risk of gastrointestinal bleeding. Daily aspirin therapy therefore should be encouraged in women aged 55–79 years and men aged 45–79 years who have few risks of aspirin-related adverse events and who have potentially large benefits in terms of their respective risk reduction (Ann. Intern. Med. 2009;150:396–410).

The guidelines are the first update to government released recommendations on the topic since 2002.

Seven years ago, “we did not have enough data available to come up with more specific recommendations based on gender,” said Dr. Michael LeFevre, a member of the task force that wrote the document. “It was really the Women's Health Study that, when added to other studies, resulted in this very clear distinction in the benefits of aspirin in men and women.”

That study evaluated the risks and benefits of aspirin in the primary prevention of heart disease in almost 40,000 women. It reported a 23% reduction in the risk of ischemic stroke with aspirin use, but no significant benefit for heart attack.

Dr. LeFevre, a professor of family medicine at the University of Missouri, Columbia, said that the recommendations are based on an individual's risk.

For men, 10-year coronary heart disease risk factors include age, total and high-density lipoprotein cholesterol levels, blood pressure, and the presence of diabetes and smoking. Similarly, 10-year stroke risk in women is estimated on the basis of age, and the presence of hypertension, diabetes, smoking, history of cardiovascular disease, atrial fibrillation, or left ventricular hypertrophy.

Men and women older than 80 years should receive careful consideration, according to the guidelines. Although the incidence of heart attack and stroke is high in this population, so is the risk of gastrointestinal bleeding. “The net benefit of aspirin use in [these patients] is probably best in those without risk factors for gastrointestinal bleeding (those with normal hemoglobin levels, good kidney function, and easy access to emergency care).”

The risk/benefit ratio should be reassessed every 5 years. The document recommends a daily aspirin dosage of 75 mg.

The USPTF recommendations differ from those offered by academic societies, including the American College of Cardiology and the American Heart Association, Dr. Christine Laine said in an interview. Such groups recommend daily aspirin therapy in patients with a high risk of cardiovascular disease or a history of heart attack, but offer no age- or gender-specific recommendations.

“It's not a sea change from the previous guidelines, but it does take advantage of these newer studies to make more definite recommendations, and helps move the decision making from less certain to more certain,” said Dr. Laine, the senior deputy editor of the Annals of Internal Medicine and a general internist at Jefferson Medical College, Philadelphia.

The recommendations “set a new standard for guidelines,” said family physician Peter P. Toth. “There is a simplicity to the recommendations, yet the data supporting them were rigorously analyzed and appropriately interpreted,” said the director of preventive cardiology at the Sterling Rock Falls Clinic in Sterling, Ill.

Because the recommendations don't require a Framingham risk calculation, they will be much more appealing to busy primary care physicians, he said in an interview. Calculating the Framingham score “was strongly recommended by National Cholesterol Education Program Guidelines in patients with two or more risk factors. However, virtually no one does it, whether they practice in an academic or community-based setting, because it is perceived to be cumbersome and time-consuming.

The U.S. Preventive Services Task Force has released the first gender- and age-specific recommendations for aspirin therapy in patients at risk of cardiovascular disease.

Drawing on data from recent studies, the new recommendations conclude that aspirin therapy reduces the risk of heart attack and ischemic stroke in appropriate male candidates, while it cuts the risk of ischemic stroke in female candidates. Both groups are at risk of gastrointestinal bleeding. Daily aspirin therapy therefore should be encouraged in women aged 55–79 years and men aged 45–79 years who have few risks of aspirin-related adverse events and who have potentially large benefits in terms of their respective risk reduction (Ann. Intern. Med. 2009;150:396–410).

The guidelines are the first update to government released recommendations on the topic since 2002.

Seven years ago, “we did not have enough data available to come up with more specific recommendations based on gender,” said Dr. Michael LeFevre, a member of the task force that wrote the document. “It was really the Women's Health Study that, when added to other studies, resulted in this very clear distinction in the benefits of aspirin in men and women.”

That study evaluated the risks and benefits of aspirin in the primary prevention of heart disease in almost 40,000 women. It reported a 23% reduction in the risk of ischemic stroke with aspirin use, but no significant benefit for heart attack.

Dr. LeFevre, a professor of family medicine at the University of Missouri, Columbia, said that the recommendations are based on an individual's risk.

For men, 10-year coronary heart disease risk factors include age, total and high-density lipoprotein cholesterol levels, blood pressure, and the presence of diabetes and smoking. Similarly, 10-year stroke risk in women is estimated on the basis of age, and the presence of hypertension, diabetes, smoking, history of cardiovascular disease, atrial fibrillation, or left ventricular hypertrophy.

Men and women older than 80 years should receive careful consideration, according to the guidelines. Although the incidence of heart attack and stroke is high in this population, so is the risk of gastrointestinal bleeding. “The net benefit of aspirin use in [these patients] is probably best in those without risk factors for gastrointestinal bleeding (those with normal hemoglobin levels, good kidney function, and easy access to emergency care).”

The risk/benefit ratio should be reassessed every 5 years. The document recommends a daily aspirin dosage of 75 mg.

The USPTF recommendations differ from those offered by academic societies, including the American College of Cardiology and the American Heart Association, Dr. Christine Laine said in an interview. Such groups recommend daily aspirin therapy in patients with a high risk of cardiovascular disease or a history of heart attack, but offer no age- or gender-specific recommendations.

“It's not a sea change from the previous guidelines, but it does take advantage of these newer studies to make more definite recommendations, and helps move the decision making from less certain to more certain,” said Dr. Laine, the senior deputy editor of the Annals of Internal Medicine and a general internist at Jefferson Medical College, Philadelphia.

The recommendations “set a new standard for guidelines,” said family physician Peter P. Toth. “There is a simplicity to the recommendations, yet the data supporting them were rigorously analyzed and appropriately interpreted,” said the director of preventive cardiology at the Sterling Rock Falls Clinic in Sterling, Ill.

Because the recommendations don't require a Framingham risk calculation, they will be much more appealing to busy primary care physicians, he said in an interview. Calculating the Framingham score “was strongly recommended by National Cholesterol Education Program Guidelines in patients with two or more risk factors. However, virtually no one does it, whether they practice in an academic or community-based setting, because it is perceived to be cumbersome and time-consuming.