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Can colorectal ESD succeed in outpatient settings?
Endoscopic submucosal dissection to remove large colorectal lesions was performed safely and successfully in an outpatient setting, based on data from more than 600 patients.
The widespread adoption of endoscopic submucosal dissection (ESD) has been slow because of its relative complexity, compared with other procedures, wrote Viktor Tidehag, MD, of Danderyd Hospital, Stockholm, and colleagues. The technique, first developed in Japan, is usually an inpatient procedure in Asian countries, the researchers said. However, “We have previously published a study of 156 ESD patients discharged after 2-4 hours of observation post ESD, providing a proof of concept that uncomplicated colorectal ESD can be safely performed as an outpatient procedure,” they wrote.
In a study published in Gastrointestinal Endoscopy, the researchers reviewed data from a larger group of 660 consecutive colorectal ESD procedures at a single center between April 2014 and November 2020. Of these, 48 were planned admission and 612 were scheduled as outpatient procedures. All patients had lesions greater than 20 mm; the median size of the lesions was 38 mm, but the median lesion size was significantly smaller for outpatients, compared with inpatients (37 mm vs. 55 mm). The lesions included 323 (48.9%) in the proximal colon, 102 (15.5%) in the distal colon, and 235 (35.6%) in the rectum. The median procedure duration was 70 minutes, but was significantly shorter for outpatients, compared with inpatients (65 minutes vs. 121 minutes). The mean age of patients in the outpatient and inpatient groups was 68.7 years vs. 70.6 years.
Overall, en bloc resection was achieved in 620 (93.9%) cases, 30 were completed as piecemeal resections, and 10 were aborted and referred for surgical resection. A total of 33 of the scheduled outpatient procedures turned into unplanned inpatient procedures.
As for intraoperative adverse events, no significant differences in perforation rate occurred between inpatients and outpatients. Overall, perforation occurred in 38 cases (5.8%); 35 of these were treated with clip and 21 also were treated with antibiotics. A total of three patients required emergency surgery following perforations.
Within 30 days of the procedures, 46 patients (7.0%) sought medical attention for possible procedure-related concerns, the researchers said. “No correlation was found between 30-day complications and lesion location, resection speed, age, or perioperative perforation,” the researchers wrote in their discussion of the findings.
The study findings were limited by several factors including the retrospective, nonrandomized design from a single center, with no controls, as well as the potential for selection bias of healthy patients selected for outpatient procedures, and lack of data on comorbidities, the researchers noted. However, the results were strengthened by the inclusion of a large number of lesions in the proximal colon, they said.
Endoscopic treatment is associated with lower mortality and morbidity, as well as lower costs, compared with laparoscopic and open surgery, and ESD could have a significant effect on health economics if widely implemented, the researchers noted in their discussion. “Being able to perform ESD in an outpatient setting compared to an inpatient situation would further decrease treatment costs compared to resection surgery,” they said. However, “patients must be well informed about the anticipated postoperative course and potential complications that can arise,” particularly in relation to intraprocedural or delayed perforation, they concluded.
Data support adoption of ESD
The current study was informative and will provide more support for adoption of colorectal ESD in the West, said Salmaan Jawaid, MD, of Baylor College of Medicine, Houston, in an interview.
“Health economics in Asian countries are strikingly different than in other countries and support routine postprocedural admissions for observation,” Dr. Jawaid said. “Colorectal ESD has been slow to gain momentum in the West due to a steep learning curve, long procedural times, and the potential for complications with resultant hospital admissions. These logistical elements and impact on health care economics in the West serve as tremendous deterrents [of] adoption of colorectal ESD,” he explained.
“The current study demonstrates colorectal ESD, in a European health care system, may be feasible and safe in an outpatient setting, thereby effectively utilizing health care resources,” said Dr. Jawaid. “If admission after colorectal ESD is not routinely needed, health care systems may be more willing to support ESD on a broader scale with a consequent increase in surgery-saving procedures,” he noted.
Dr. Jawaid said he was not surprised by the findings overall. “However, I did find it interesting the number of patients who were safely discharged the same day after suffering colonic perforations,” he noted. He suspects improved methods of defect closure would explain this, and could in turn increase the rate of adoption.
“In experienced hands, I believe similar results will be attainable in a U.S.-based health care system,” he added.
However, “Validated protocol-based clinical pathways are needed in the West before widespread outpatient colorectal ESD is implemented. In the United States, emphasis should be made on the development of long-term educational systems whose primary goal is to ensure proper skills are acquired for endoscopic dissection,” he emphasized. “If support from a U.S. health care system is desired on a larger scale, detailed cost-benefit analyses are needed comparing all modalities of colon polyp removal.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Jawaid disclosed serving as a consultant for Lumendi and Conmed.
This article was updated March 15, 2022.
Endoscopic submucosal dissection to remove large colorectal lesions was performed safely and successfully in an outpatient setting, based on data from more than 600 patients.
The widespread adoption of endoscopic submucosal dissection (ESD) has been slow because of its relative complexity, compared with other procedures, wrote Viktor Tidehag, MD, of Danderyd Hospital, Stockholm, and colleagues. The technique, first developed in Japan, is usually an inpatient procedure in Asian countries, the researchers said. However, “We have previously published a study of 156 ESD patients discharged after 2-4 hours of observation post ESD, providing a proof of concept that uncomplicated colorectal ESD can be safely performed as an outpatient procedure,” they wrote.
In a study published in Gastrointestinal Endoscopy, the researchers reviewed data from a larger group of 660 consecutive colorectal ESD procedures at a single center between April 2014 and November 2020. Of these, 48 were planned admission and 612 were scheduled as outpatient procedures. All patients had lesions greater than 20 mm; the median size of the lesions was 38 mm, but the median lesion size was significantly smaller for outpatients, compared with inpatients (37 mm vs. 55 mm). The lesions included 323 (48.9%) in the proximal colon, 102 (15.5%) in the distal colon, and 235 (35.6%) in the rectum. The median procedure duration was 70 minutes, but was significantly shorter for outpatients, compared with inpatients (65 minutes vs. 121 minutes). The mean age of patients in the outpatient and inpatient groups was 68.7 years vs. 70.6 years.
Overall, en bloc resection was achieved in 620 (93.9%) cases, 30 were completed as piecemeal resections, and 10 were aborted and referred for surgical resection. A total of 33 of the scheduled outpatient procedures turned into unplanned inpatient procedures.
As for intraoperative adverse events, no significant differences in perforation rate occurred between inpatients and outpatients. Overall, perforation occurred in 38 cases (5.8%); 35 of these were treated with clip and 21 also were treated with antibiotics. A total of three patients required emergency surgery following perforations.
Within 30 days of the procedures, 46 patients (7.0%) sought medical attention for possible procedure-related concerns, the researchers said. “No correlation was found between 30-day complications and lesion location, resection speed, age, or perioperative perforation,” the researchers wrote in their discussion of the findings.
The study findings were limited by several factors including the retrospective, nonrandomized design from a single center, with no controls, as well as the potential for selection bias of healthy patients selected for outpatient procedures, and lack of data on comorbidities, the researchers noted. However, the results were strengthened by the inclusion of a large number of lesions in the proximal colon, they said.
Endoscopic treatment is associated with lower mortality and morbidity, as well as lower costs, compared with laparoscopic and open surgery, and ESD could have a significant effect on health economics if widely implemented, the researchers noted in their discussion. “Being able to perform ESD in an outpatient setting compared to an inpatient situation would further decrease treatment costs compared to resection surgery,” they said. However, “patients must be well informed about the anticipated postoperative course and potential complications that can arise,” particularly in relation to intraprocedural or delayed perforation, they concluded.
Data support adoption of ESD
The current study was informative and will provide more support for adoption of colorectal ESD in the West, said Salmaan Jawaid, MD, of Baylor College of Medicine, Houston, in an interview.
“Health economics in Asian countries are strikingly different than in other countries and support routine postprocedural admissions for observation,” Dr. Jawaid said. “Colorectal ESD has been slow to gain momentum in the West due to a steep learning curve, long procedural times, and the potential for complications with resultant hospital admissions. These logistical elements and impact on health care economics in the West serve as tremendous deterrents [of] adoption of colorectal ESD,” he explained.
“The current study demonstrates colorectal ESD, in a European health care system, may be feasible and safe in an outpatient setting, thereby effectively utilizing health care resources,” said Dr. Jawaid. “If admission after colorectal ESD is not routinely needed, health care systems may be more willing to support ESD on a broader scale with a consequent increase in surgery-saving procedures,” he noted.
Dr. Jawaid said he was not surprised by the findings overall. “However, I did find it interesting the number of patients who were safely discharged the same day after suffering colonic perforations,” he noted. He suspects improved methods of defect closure would explain this, and could in turn increase the rate of adoption.
“In experienced hands, I believe similar results will be attainable in a U.S.-based health care system,” he added.
However, “Validated protocol-based clinical pathways are needed in the West before widespread outpatient colorectal ESD is implemented. In the United States, emphasis should be made on the development of long-term educational systems whose primary goal is to ensure proper skills are acquired for endoscopic dissection,” he emphasized. “If support from a U.S. health care system is desired on a larger scale, detailed cost-benefit analyses are needed comparing all modalities of colon polyp removal.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Jawaid disclosed serving as a consultant for Lumendi and Conmed.
This article was updated March 15, 2022.
Endoscopic submucosal dissection to remove large colorectal lesions was performed safely and successfully in an outpatient setting, based on data from more than 600 patients.
The widespread adoption of endoscopic submucosal dissection (ESD) has been slow because of its relative complexity, compared with other procedures, wrote Viktor Tidehag, MD, of Danderyd Hospital, Stockholm, and colleagues. The technique, first developed in Japan, is usually an inpatient procedure in Asian countries, the researchers said. However, “We have previously published a study of 156 ESD patients discharged after 2-4 hours of observation post ESD, providing a proof of concept that uncomplicated colorectal ESD can be safely performed as an outpatient procedure,” they wrote.
In a study published in Gastrointestinal Endoscopy, the researchers reviewed data from a larger group of 660 consecutive colorectal ESD procedures at a single center between April 2014 and November 2020. Of these, 48 were planned admission and 612 were scheduled as outpatient procedures. All patients had lesions greater than 20 mm; the median size of the lesions was 38 mm, but the median lesion size was significantly smaller for outpatients, compared with inpatients (37 mm vs. 55 mm). The lesions included 323 (48.9%) in the proximal colon, 102 (15.5%) in the distal colon, and 235 (35.6%) in the rectum. The median procedure duration was 70 minutes, but was significantly shorter for outpatients, compared with inpatients (65 minutes vs. 121 minutes). The mean age of patients in the outpatient and inpatient groups was 68.7 years vs. 70.6 years.
Overall, en bloc resection was achieved in 620 (93.9%) cases, 30 were completed as piecemeal resections, and 10 were aborted and referred for surgical resection. A total of 33 of the scheduled outpatient procedures turned into unplanned inpatient procedures.
As for intraoperative adverse events, no significant differences in perforation rate occurred between inpatients and outpatients. Overall, perforation occurred in 38 cases (5.8%); 35 of these were treated with clip and 21 also were treated with antibiotics. A total of three patients required emergency surgery following perforations.
Within 30 days of the procedures, 46 patients (7.0%) sought medical attention for possible procedure-related concerns, the researchers said. “No correlation was found between 30-day complications and lesion location, resection speed, age, or perioperative perforation,” the researchers wrote in their discussion of the findings.
The study findings were limited by several factors including the retrospective, nonrandomized design from a single center, with no controls, as well as the potential for selection bias of healthy patients selected for outpatient procedures, and lack of data on comorbidities, the researchers noted. However, the results were strengthened by the inclusion of a large number of lesions in the proximal colon, they said.
Endoscopic treatment is associated with lower mortality and morbidity, as well as lower costs, compared with laparoscopic and open surgery, and ESD could have a significant effect on health economics if widely implemented, the researchers noted in their discussion. “Being able to perform ESD in an outpatient setting compared to an inpatient situation would further decrease treatment costs compared to resection surgery,” they said. However, “patients must be well informed about the anticipated postoperative course and potential complications that can arise,” particularly in relation to intraprocedural or delayed perforation, they concluded.
Data support adoption of ESD
The current study was informative and will provide more support for adoption of colorectal ESD in the West, said Salmaan Jawaid, MD, of Baylor College of Medicine, Houston, in an interview.
“Health economics in Asian countries are strikingly different than in other countries and support routine postprocedural admissions for observation,” Dr. Jawaid said. “Colorectal ESD has been slow to gain momentum in the West due to a steep learning curve, long procedural times, and the potential for complications with resultant hospital admissions. These logistical elements and impact on health care economics in the West serve as tremendous deterrents [of] adoption of colorectal ESD,” he explained.
“The current study demonstrates colorectal ESD, in a European health care system, may be feasible and safe in an outpatient setting, thereby effectively utilizing health care resources,” said Dr. Jawaid. “If admission after colorectal ESD is not routinely needed, health care systems may be more willing to support ESD on a broader scale with a consequent increase in surgery-saving procedures,” he noted.
Dr. Jawaid said he was not surprised by the findings overall. “However, I did find it interesting the number of patients who were safely discharged the same day after suffering colonic perforations,” he noted. He suspects improved methods of defect closure would explain this, and could in turn increase the rate of adoption.
“In experienced hands, I believe similar results will be attainable in a U.S.-based health care system,” he added.
However, “Validated protocol-based clinical pathways are needed in the West before widespread outpatient colorectal ESD is implemented. In the United States, emphasis should be made on the development of long-term educational systems whose primary goal is to ensure proper skills are acquired for endoscopic dissection,” he emphasized. “If support from a U.S. health care system is desired on a larger scale, detailed cost-benefit analyses are needed comparing all modalities of colon polyp removal.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Jawaid disclosed serving as a consultant for Lumendi and Conmed.
This article was updated March 15, 2022.
FROM GASTROINTESTINAL ENDOSCOPY
Drug survival study looks at what lasts longest in RA, axSpA, PsA, and psoriasis
Survival rates of biologics and other novel immunomodulatory drugs vary substantially across chronic inflammatory diseases, and rates are highest for rituximab in rheumatoid arthritis (RA) and golimumab in axial spondyloarthritis (axSpA), but with similar rates seen for most drugs used in the treatment of psoriasis and psoriatic arthritis (PsA), according to findings from a study of two Danish registries.
Drug survival refers to “the probability that patients will remain on a given drug, and is a proxy for efficacy as well as safety in daily clinical practice,” wrote Alexander Egeberg, MD, PhD, of the department of dermatology at Copenhagen University Hospital–Bispebjerg, and colleagues. Although the use of biologics has expanded for inflammatory diseases, real-world data on drug survival in newer agents such as interleukin (IL)-17, IL-23, and Janus kinase inhibitors are lacking, they said.
In a study published in Seminars in Arthritis and Rheumatism, the researchers reviewed data from the DANBIO and DERMBIO registries of patients in Denmark with inflammatory diseases including rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis.
The study population included 12,089 adults: 5,104 with RA, 2,157 with AxSpA, 2,251 with PsA, and 2,577 with psoriasis. Patients’ mean age at the time of first treatment for these conditions was 57.8 years, 42.3 years, 49 years, and 45 years, respectively. Participants were treated with biologics or novel small molecule therapies for RA, AxSpA, PsA, or psoriasis between January 2015 and May 2021 (from the DANBIO database) and November 2009 to November 2019 (DERMBIO database).
In adjusted models, drug survival in RA was highest for rituximab followed by baricitinib, etanercept, and tocilizumab. Drug survival in AxSpA was highest for golimumab, compared with all other drugs, followed by secukinumab and etanercept. Survival was lowest for infliximab. In PsA, drug survival was roughly equal for most drugs, including golimumab, secukinumab, and ixekizumab, with the lowest survival observed for tofacitinib and infliximab, compared with all other drugs. Drug survival in psoriasis was highest with guselkumab, followed by ustekinumab and IL-17 inhibitors.
However, the number of treatment series “was low for some drugs, and not all differences were statistically significant, which could influence the overall interpretability of these findings,” the researchers noted in their discussion.
Notably, the high treatment persistence for rituximab in RA patients needs further confirmation, the researchers said. “In Denmark, rituximab is often the biologic drug of choice in RA patients with a history of cancer while there is a reluctancy to use TNF [tumor necrosis factor] inhibitors in such patients; this may have prolonged the drug survival for rituximab treated patients due to limited treatment alternatives,” they said.
The findings were limited by several factors, including the observational study design and changes in guidelines over the course of the study, the researchers noted. Other limitations included the inability to adjust for certain variables, such as antibody status, body weight, and smoking, because of missing data, and a lack of data on the underlying reasons for drug discontinuation, they said.
However, the results were strengthened by the large number of patients and completeness of the registries, the researchers emphasized. The range in responses to different drug types across diseases supports the need for individualized treatments with attention to underlying disease, patient profile, and treatment history, they concluded.
The study received no outside funding. Eight coauthors reported financial ties to a number of pharmaceutical companies.
Survival rates of biologics and other novel immunomodulatory drugs vary substantially across chronic inflammatory diseases, and rates are highest for rituximab in rheumatoid arthritis (RA) and golimumab in axial spondyloarthritis (axSpA), but with similar rates seen for most drugs used in the treatment of psoriasis and psoriatic arthritis (PsA), according to findings from a study of two Danish registries.
Drug survival refers to “the probability that patients will remain on a given drug, and is a proxy for efficacy as well as safety in daily clinical practice,” wrote Alexander Egeberg, MD, PhD, of the department of dermatology at Copenhagen University Hospital–Bispebjerg, and colleagues. Although the use of biologics has expanded for inflammatory diseases, real-world data on drug survival in newer agents such as interleukin (IL)-17, IL-23, and Janus kinase inhibitors are lacking, they said.
In a study published in Seminars in Arthritis and Rheumatism, the researchers reviewed data from the DANBIO and DERMBIO registries of patients in Denmark with inflammatory diseases including rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis.
The study population included 12,089 adults: 5,104 with RA, 2,157 with AxSpA, 2,251 with PsA, and 2,577 with psoriasis. Patients’ mean age at the time of first treatment for these conditions was 57.8 years, 42.3 years, 49 years, and 45 years, respectively. Participants were treated with biologics or novel small molecule therapies for RA, AxSpA, PsA, or psoriasis between January 2015 and May 2021 (from the DANBIO database) and November 2009 to November 2019 (DERMBIO database).
In adjusted models, drug survival in RA was highest for rituximab followed by baricitinib, etanercept, and tocilizumab. Drug survival in AxSpA was highest for golimumab, compared with all other drugs, followed by secukinumab and etanercept. Survival was lowest for infliximab. In PsA, drug survival was roughly equal for most drugs, including golimumab, secukinumab, and ixekizumab, with the lowest survival observed for tofacitinib and infliximab, compared with all other drugs. Drug survival in psoriasis was highest with guselkumab, followed by ustekinumab and IL-17 inhibitors.
However, the number of treatment series “was low for some drugs, and not all differences were statistically significant, which could influence the overall interpretability of these findings,” the researchers noted in their discussion.
Notably, the high treatment persistence for rituximab in RA patients needs further confirmation, the researchers said. “In Denmark, rituximab is often the biologic drug of choice in RA patients with a history of cancer while there is a reluctancy to use TNF [tumor necrosis factor] inhibitors in such patients; this may have prolonged the drug survival for rituximab treated patients due to limited treatment alternatives,” they said.
The findings were limited by several factors, including the observational study design and changes in guidelines over the course of the study, the researchers noted. Other limitations included the inability to adjust for certain variables, such as antibody status, body weight, and smoking, because of missing data, and a lack of data on the underlying reasons for drug discontinuation, they said.
However, the results were strengthened by the large number of patients and completeness of the registries, the researchers emphasized. The range in responses to different drug types across diseases supports the need for individualized treatments with attention to underlying disease, patient profile, and treatment history, they concluded.
The study received no outside funding. Eight coauthors reported financial ties to a number of pharmaceutical companies.
Survival rates of biologics and other novel immunomodulatory drugs vary substantially across chronic inflammatory diseases, and rates are highest for rituximab in rheumatoid arthritis (RA) and golimumab in axial spondyloarthritis (axSpA), but with similar rates seen for most drugs used in the treatment of psoriasis and psoriatic arthritis (PsA), according to findings from a study of two Danish registries.
Drug survival refers to “the probability that patients will remain on a given drug, and is a proxy for efficacy as well as safety in daily clinical practice,” wrote Alexander Egeberg, MD, PhD, of the department of dermatology at Copenhagen University Hospital–Bispebjerg, and colleagues. Although the use of biologics has expanded for inflammatory diseases, real-world data on drug survival in newer agents such as interleukin (IL)-17, IL-23, and Janus kinase inhibitors are lacking, they said.
In a study published in Seminars in Arthritis and Rheumatism, the researchers reviewed data from the DANBIO and DERMBIO registries of patients in Denmark with inflammatory diseases including rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis.
The study population included 12,089 adults: 5,104 with RA, 2,157 with AxSpA, 2,251 with PsA, and 2,577 with psoriasis. Patients’ mean age at the time of first treatment for these conditions was 57.8 years, 42.3 years, 49 years, and 45 years, respectively. Participants were treated with biologics or novel small molecule therapies for RA, AxSpA, PsA, or psoriasis between January 2015 and May 2021 (from the DANBIO database) and November 2009 to November 2019 (DERMBIO database).
In adjusted models, drug survival in RA was highest for rituximab followed by baricitinib, etanercept, and tocilizumab. Drug survival in AxSpA was highest for golimumab, compared with all other drugs, followed by secukinumab and etanercept. Survival was lowest for infliximab. In PsA, drug survival was roughly equal for most drugs, including golimumab, secukinumab, and ixekizumab, with the lowest survival observed for tofacitinib and infliximab, compared with all other drugs. Drug survival in psoriasis was highest with guselkumab, followed by ustekinumab and IL-17 inhibitors.
However, the number of treatment series “was low for some drugs, and not all differences were statistically significant, which could influence the overall interpretability of these findings,” the researchers noted in their discussion.
Notably, the high treatment persistence for rituximab in RA patients needs further confirmation, the researchers said. “In Denmark, rituximab is often the biologic drug of choice in RA patients with a history of cancer while there is a reluctancy to use TNF [tumor necrosis factor] inhibitors in such patients; this may have prolonged the drug survival for rituximab treated patients due to limited treatment alternatives,” they said.
The findings were limited by several factors, including the observational study design and changes in guidelines over the course of the study, the researchers noted. Other limitations included the inability to adjust for certain variables, such as antibody status, body weight, and smoking, because of missing data, and a lack of data on the underlying reasons for drug discontinuation, they said.
However, the results were strengthened by the large number of patients and completeness of the registries, the researchers emphasized. The range in responses to different drug types across diseases supports the need for individualized treatments with attention to underlying disease, patient profile, and treatment history, they concluded.
The study received no outside funding. Eight coauthors reported financial ties to a number of pharmaceutical companies.
FROM SEMINARS IN ARTHRITIS AND RHEUMATISM
Hodgkin-directed therapy may benefit patients with rare CLL subtype
Patients who have a rare subtype of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with isolated Hodgkin/Reed–Sternberg-like cells (CLL-HRS) may benefit from Hodgkin-directed therapy, based on data from 46 individuals.
Those patients who progress to classic Hodgkin lymphoma (CHL) from CLL/SLL are generally diagnosed based on straightforward pathology and treated with HRS cells in the same way as patients with de novo CHL, wrote lead author Dr. Rebecca L. King, a pathologist at the Mayo Clinic in Rochester, Minn.
Given the rarity of CLL-HRS, data on patient management are limited, they noted.
In a retrospective study published in Blood Cancer Journal, researchers reviewed outcome data from 15 adults with CLL-HRS and 31 adults with CLL/SLL who had overtly transformed to CLL-HL. The median age of the participants at the time of CLL-HL or CLL-HRS transformation diagnosis was 72 years; 71% and 87% of the CLL-HL and CLL-HRS patients, respectively, were male.
The median times from CLL to CLL-HL transformation and from CLL to CLL-HRS transformation were 6.6 years and 4.9 years, respectively; the difference was not statistically significant. The phenotypic features of Reed-Sternberg cells and Epstein-Barr virus status were similar in both patient groups. Two patients had biopsies in which both CLL-HRS and CLL-HL were present in the same tissue at initial diagnosis; they were included in the CLL-HL group for clinical analysis and in both groups for pathology analysis.
The median overall survival of CLL-HRS patients was 17.5 months, compared with 33.5 months for CLL-HL patients (P = .24), a nonsignificant difference. However, patients with CLL-HRS who received Hodgkin-directed therapy had a significantly longer median overall survival, compared with those who received CLL-directed therapy (57 months vs. 8.4 months, P = .02).
CLL-directed therapy included rituximab with or without corticosteroids, chemoimmunotherapy, or acalabrutinib; HL-directed therapy included doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine–based treatment; radiotherapy; or BCVPP (carmustine, cyclophosphamide, vinblastine, procarbazine, and prednisone).
Histopathology findings showed that CLL-HL patients had a background of mixed inflammation that was distinct from findings in CLL/SLL. CLL-HRS patients had a minimal inflammatory background, compared with CLL-HL cases, but researchers identified rosetting of T cells around the HRS cells in 56% of these patients.
“Our findings suggest that, clinically and pathologically, these patients show a spectrum of findings, and these two entities likely exist on a biologic continuum. Furthermore, our findings suggest that CLL-HRS patients managed with Hodgkin-directed therapy, rather than CLL-directed therapy, may have superior outcomes,” the researchers wrote.
The study findings were limited by several factors, including the retrospective design and the use of data from a single center. Therefore, the results should be validated in other cohorts, the researchers noted. In addition, the study participants were diagnosed over three decades, and management of the condition has significantly improved.
However, the results were strengthened by a review of data by three pathologists who were blinded to the clinical outcomes, they said.
“These findings have important implications for a scenario in which clinical guidelines are lacking and suggest that hematologists treating patients with CLL-HRS should consider HL-directed therapy,” the researchers concluded.
In an interview, Jennifer A. Woyach, MD, a hematologist at Ohio State University, Columbus, commented on the study findings: “Hodgkin transformation and CLL with Hodgkin-like cells likely represent a biologic continuum, and care should be taken to obtain adequate biopsies, so that the diagnosis of Hodgkin transformation can be made when appropriate.”
“Interestingly, the authors noted a trend toward improved survival when CLL with Hodgkin-like cells was treated with standard Hodgkin regimens,” said Dr. Woyach. “With the small patient numbers, this certainly cannot be a general recommendation, but should be considered by treating physicians on a case-by-case basis.”
“While we know that patients with Hodgkin transformation can in many cases be successfully treated with standard Hodgkin regimen, the natural history and optimal treatment for CLL with Hodgkin-like cells have been unknown. This analysis helps understand the biologic difference between these two clinicopathologic entities to understand how to better treat patients,” she noted. Going forward, “it would be extremely helpful to see these data validated by other centers to be sure that these results are reproducible,” Dr. Woyach added.
The study was supported by the Mayo Clinic, Rochester, Minn., and by the Henry J. Predolin Foundation. Lead author Dr. King disclosed research support to her institution from Bristol-Myers Squibb/Celgene. Dr. Woyach had no financial disclosures relevant to this study, but she has received laboratory research funding from Schrodinger and has consulted for AbbVie, Pharmacyclics, Janssen, AstraZeneca, Genentech, Beigene, Loxo, and Newave.
This article was updated 3/11/22.
Patients who have a rare subtype of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with isolated Hodgkin/Reed–Sternberg-like cells (CLL-HRS) may benefit from Hodgkin-directed therapy, based on data from 46 individuals.
Those patients who progress to classic Hodgkin lymphoma (CHL) from CLL/SLL are generally diagnosed based on straightforward pathology and treated with HRS cells in the same way as patients with de novo CHL, wrote lead author Dr. Rebecca L. King, a pathologist at the Mayo Clinic in Rochester, Minn.
Given the rarity of CLL-HRS, data on patient management are limited, they noted.
In a retrospective study published in Blood Cancer Journal, researchers reviewed outcome data from 15 adults with CLL-HRS and 31 adults with CLL/SLL who had overtly transformed to CLL-HL. The median age of the participants at the time of CLL-HL or CLL-HRS transformation diagnosis was 72 years; 71% and 87% of the CLL-HL and CLL-HRS patients, respectively, were male.
The median times from CLL to CLL-HL transformation and from CLL to CLL-HRS transformation were 6.6 years and 4.9 years, respectively; the difference was not statistically significant. The phenotypic features of Reed-Sternberg cells and Epstein-Barr virus status were similar in both patient groups. Two patients had biopsies in which both CLL-HRS and CLL-HL were present in the same tissue at initial diagnosis; they were included in the CLL-HL group for clinical analysis and in both groups for pathology analysis.
The median overall survival of CLL-HRS patients was 17.5 months, compared with 33.5 months for CLL-HL patients (P = .24), a nonsignificant difference. However, patients with CLL-HRS who received Hodgkin-directed therapy had a significantly longer median overall survival, compared with those who received CLL-directed therapy (57 months vs. 8.4 months, P = .02).
CLL-directed therapy included rituximab with or without corticosteroids, chemoimmunotherapy, or acalabrutinib; HL-directed therapy included doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine–based treatment; radiotherapy; or BCVPP (carmustine, cyclophosphamide, vinblastine, procarbazine, and prednisone).
Histopathology findings showed that CLL-HL patients had a background of mixed inflammation that was distinct from findings in CLL/SLL. CLL-HRS patients had a minimal inflammatory background, compared with CLL-HL cases, but researchers identified rosetting of T cells around the HRS cells in 56% of these patients.
“Our findings suggest that, clinically and pathologically, these patients show a spectrum of findings, and these two entities likely exist on a biologic continuum. Furthermore, our findings suggest that CLL-HRS patients managed with Hodgkin-directed therapy, rather than CLL-directed therapy, may have superior outcomes,” the researchers wrote.
The study findings were limited by several factors, including the retrospective design and the use of data from a single center. Therefore, the results should be validated in other cohorts, the researchers noted. In addition, the study participants were diagnosed over three decades, and management of the condition has significantly improved.
However, the results were strengthened by a review of data by three pathologists who were blinded to the clinical outcomes, they said.
“These findings have important implications for a scenario in which clinical guidelines are lacking and suggest that hematologists treating patients with CLL-HRS should consider HL-directed therapy,” the researchers concluded.
In an interview, Jennifer A. Woyach, MD, a hematologist at Ohio State University, Columbus, commented on the study findings: “Hodgkin transformation and CLL with Hodgkin-like cells likely represent a biologic continuum, and care should be taken to obtain adequate biopsies, so that the diagnosis of Hodgkin transformation can be made when appropriate.”
“Interestingly, the authors noted a trend toward improved survival when CLL with Hodgkin-like cells was treated with standard Hodgkin regimens,” said Dr. Woyach. “With the small patient numbers, this certainly cannot be a general recommendation, but should be considered by treating physicians on a case-by-case basis.”
“While we know that patients with Hodgkin transformation can in many cases be successfully treated with standard Hodgkin regimen, the natural history and optimal treatment for CLL with Hodgkin-like cells have been unknown. This analysis helps understand the biologic difference between these two clinicopathologic entities to understand how to better treat patients,” she noted. Going forward, “it would be extremely helpful to see these data validated by other centers to be sure that these results are reproducible,” Dr. Woyach added.
The study was supported by the Mayo Clinic, Rochester, Minn., and by the Henry J. Predolin Foundation. Lead author Dr. King disclosed research support to her institution from Bristol-Myers Squibb/Celgene. Dr. Woyach had no financial disclosures relevant to this study, but she has received laboratory research funding from Schrodinger and has consulted for AbbVie, Pharmacyclics, Janssen, AstraZeneca, Genentech, Beigene, Loxo, and Newave.
This article was updated 3/11/22.
Patients who have a rare subtype of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with isolated Hodgkin/Reed–Sternberg-like cells (CLL-HRS) may benefit from Hodgkin-directed therapy, based on data from 46 individuals.
Those patients who progress to classic Hodgkin lymphoma (CHL) from CLL/SLL are generally diagnosed based on straightforward pathology and treated with HRS cells in the same way as patients with de novo CHL, wrote lead author Dr. Rebecca L. King, a pathologist at the Mayo Clinic in Rochester, Minn.
Given the rarity of CLL-HRS, data on patient management are limited, they noted.
In a retrospective study published in Blood Cancer Journal, researchers reviewed outcome data from 15 adults with CLL-HRS and 31 adults with CLL/SLL who had overtly transformed to CLL-HL. The median age of the participants at the time of CLL-HL or CLL-HRS transformation diagnosis was 72 years; 71% and 87% of the CLL-HL and CLL-HRS patients, respectively, were male.
The median times from CLL to CLL-HL transformation and from CLL to CLL-HRS transformation were 6.6 years and 4.9 years, respectively; the difference was not statistically significant. The phenotypic features of Reed-Sternberg cells and Epstein-Barr virus status were similar in both patient groups. Two patients had biopsies in which both CLL-HRS and CLL-HL were present in the same tissue at initial diagnosis; they were included in the CLL-HL group for clinical analysis and in both groups for pathology analysis.
The median overall survival of CLL-HRS patients was 17.5 months, compared with 33.5 months for CLL-HL patients (P = .24), a nonsignificant difference. However, patients with CLL-HRS who received Hodgkin-directed therapy had a significantly longer median overall survival, compared with those who received CLL-directed therapy (57 months vs. 8.4 months, P = .02).
CLL-directed therapy included rituximab with or without corticosteroids, chemoimmunotherapy, or acalabrutinib; HL-directed therapy included doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine–based treatment; radiotherapy; or BCVPP (carmustine, cyclophosphamide, vinblastine, procarbazine, and prednisone).
Histopathology findings showed that CLL-HL patients had a background of mixed inflammation that was distinct from findings in CLL/SLL. CLL-HRS patients had a minimal inflammatory background, compared with CLL-HL cases, but researchers identified rosetting of T cells around the HRS cells in 56% of these patients.
“Our findings suggest that, clinically and pathologically, these patients show a spectrum of findings, and these two entities likely exist on a biologic continuum. Furthermore, our findings suggest that CLL-HRS patients managed with Hodgkin-directed therapy, rather than CLL-directed therapy, may have superior outcomes,” the researchers wrote.
The study findings were limited by several factors, including the retrospective design and the use of data from a single center. Therefore, the results should be validated in other cohorts, the researchers noted. In addition, the study participants were diagnosed over three decades, and management of the condition has significantly improved.
However, the results were strengthened by a review of data by three pathologists who were blinded to the clinical outcomes, they said.
“These findings have important implications for a scenario in which clinical guidelines are lacking and suggest that hematologists treating patients with CLL-HRS should consider HL-directed therapy,” the researchers concluded.
In an interview, Jennifer A. Woyach, MD, a hematologist at Ohio State University, Columbus, commented on the study findings: “Hodgkin transformation and CLL with Hodgkin-like cells likely represent a biologic continuum, and care should be taken to obtain adequate biopsies, so that the diagnosis of Hodgkin transformation can be made when appropriate.”
“Interestingly, the authors noted a trend toward improved survival when CLL with Hodgkin-like cells was treated with standard Hodgkin regimens,” said Dr. Woyach. “With the small patient numbers, this certainly cannot be a general recommendation, but should be considered by treating physicians on a case-by-case basis.”
“While we know that patients with Hodgkin transformation can in many cases be successfully treated with standard Hodgkin regimen, the natural history and optimal treatment for CLL with Hodgkin-like cells have been unknown. This analysis helps understand the biologic difference between these two clinicopathologic entities to understand how to better treat patients,” she noted. Going forward, “it would be extremely helpful to see these data validated by other centers to be sure that these results are reproducible,” Dr. Woyach added.
The study was supported by the Mayo Clinic, Rochester, Minn., and by the Henry J. Predolin Foundation. Lead author Dr. King disclosed research support to her institution from Bristol-Myers Squibb/Celgene. Dr. Woyach had no financial disclosures relevant to this study, but she has received laboratory research funding from Schrodinger and has consulted for AbbVie, Pharmacyclics, Janssen, AstraZeneca, Genentech, Beigene, Loxo, and Newave.
This article was updated 3/11/22.
FROM BLOOD CANCER JOURNAL
Mutation drives persistent Pseudomonas in COPD
Pseudomonas aeruginosa persisted in the airways of patients with chronic obstructive pulmonary disease (COPD), based on data from 23 patients over a 1-year period.
P. aeruginosa is cultured in as many as 20% of bacterial exacerbations and has been linked to increased morbidity and mortality in patients with COPD, wrote Josefin Eklöf, MD, of the University of Copenhagen and colleagues. However, its patterns and characteristics have not been well studied, and researchers proposed that P. aerunginosa persists in COPD patients in part because of genetic adaptations in the genes related to antibiotic resistance.
In a study published in Clinical Microbiology and Infection, the researchers identified 23 consecutive patients enrolled in an ongoing randomized clinical trial at four sites in Denmark between Jan. 2018 and Jan. 2020. Participants were randomized 1:1 to targeted antipseudomonal antibiotic treatment for 14 days (between visit day 1 and visit day 14) or no antipseudomonal treatment. Sputum samples were collected at baseline on day 1 and on days 14, 30, 60, 90, and 365.
The researchers sequenced isolates from 23 adult patients over 365 days of follow-up. The recurrence of P. aeruginosa occurred in 19 patients (83%) during this period. Ultimately, a total of 153 isolates were analyzed. The researchers found that each patient carried their own unique lineage, with the except of one patient in whom two distinct lineages were identified.
“Independent mutation of the same gene across multiple lineages may be the result of positive selection of adaptive mutations,” Dr. Eklöf and colleagues wrote. They found 38 genes for P. aeruginosa that were mutated in at least two lineages, which suggested adaptive mutations. Some of the more frequently mutated genes were those important to antibiotic resistance and chronic infections, the researchers said. Specifically, mutations occurred in 40 of 140 pathoadaptive genes, compared with 265 of 5,572 other genes (P < .001). In addition, the 24 total lineages carried 4-6 antibiotic resistance genes, and no evidence suggested that lineages acquired or lost these genes during carriage.
Overall, the results indicate that the recurrence of P. aeruginosa was caused by persistence of the same clonal lineage in each patient. “This pattern of persistence was associated with genetic adaptation related to phenotypes considered important for P. aeruginosa infections,” the researchers said.
The study findings were limited by the relatively small number of samples and isolates per sample, the follow-up of only 1 year, and the inability to account for mutations in the early stage because few patients were naive to P. aeruginosa at the start of the study, the researchers noted. However, the results were strengthened by the relatively large and well-defined study population and high rate of sampling compliance, they said.
Overall, “the findings warrant research to improve therapy, including trial data on possible clinical benefits of attempting antibiotic eradication of P. aeruginosa in this vulnerable group of patients,” they concluded.
The study was supported by the Independent Research Fund Denmark and the Research committee at Copenhagen University Hospital-Herlev and Gentofte Hospital. The researchers had no financial conflicts to disclose.
Pseudomonas aeruginosa persisted in the airways of patients with chronic obstructive pulmonary disease (COPD), based on data from 23 patients over a 1-year period.
P. aeruginosa is cultured in as many as 20% of bacterial exacerbations and has been linked to increased morbidity and mortality in patients with COPD, wrote Josefin Eklöf, MD, of the University of Copenhagen and colleagues. However, its patterns and characteristics have not been well studied, and researchers proposed that P. aerunginosa persists in COPD patients in part because of genetic adaptations in the genes related to antibiotic resistance.
In a study published in Clinical Microbiology and Infection, the researchers identified 23 consecutive patients enrolled in an ongoing randomized clinical trial at four sites in Denmark between Jan. 2018 and Jan. 2020. Participants were randomized 1:1 to targeted antipseudomonal antibiotic treatment for 14 days (between visit day 1 and visit day 14) or no antipseudomonal treatment. Sputum samples were collected at baseline on day 1 and on days 14, 30, 60, 90, and 365.
The researchers sequenced isolates from 23 adult patients over 365 days of follow-up. The recurrence of P. aeruginosa occurred in 19 patients (83%) during this period. Ultimately, a total of 153 isolates were analyzed. The researchers found that each patient carried their own unique lineage, with the except of one patient in whom two distinct lineages were identified.
“Independent mutation of the same gene across multiple lineages may be the result of positive selection of adaptive mutations,” Dr. Eklöf and colleagues wrote. They found 38 genes for P. aeruginosa that were mutated in at least two lineages, which suggested adaptive mutations. Some of the more frequently mutated genes were those important to antibiotic resistance and chronic infections, the researchers said. Specifically, mutations occurred in 40 of 140 pathoadaptive genes, compared with 265 of 5,572 other genes (P < .001). In addition, the 24 total lineages carried 4-6 antibiotic resistance genes, and no evidence suggested that lineages acquired or lost these genes during carriage.
Overall, the results indicate that the recurrence of P. aeruginosa was caused by persistence of the same clonal lineage in each patient. “This pattern of persistence was associated with genetic adaptation related to phenotypes considered important for P. aeruginosa infections,” the researchers said.
The study findings were limited by the relatively small number of samples and isolates per sample, the follow-up of only 1 year, and the inability to account for mutations in the early stage because few patients were naive to P. aeruginosa at the start of the study, the researchers noted. However, the results were strengthened by the relatively large and well-defined study population and high rate of sampling compliance, they said.
Overall, “the findings warrant research to improve therapy, including trial data on possible clinical benefits of attempting antibiotic eradication of P. aeruginosa in this vulnerable group of patients,” they concluded.
The study was supported by the Independent Research Fund Denmark and the Research committee at Copenhagen University Hospital-Herlev and Gentofte Hospital. The researchers had no financial conflicts to disclose.
Pseudomonas aeruginosa persisted in the airways of patients with chronic obstructive pulmonary disease (COPD), based on data from 23 patients over a 1-year period.
P. aeruginosa is cultured in as many as 20% of bacterial exacerbations and has been linked to increased morbidity and mortality in patients with COPD, wrote Josefin Eklöf, MD, of the University of Copenhagen and colleagues. However, its patterns and characteristics have not been well studied, and researchers proposed that P. aerunginosa persists in COPD patients in part because of genetic adaptations in the genes related to antibiotic resistance.
In a study published in Clinical Microbiology and Infection, the researchers identified 23 consecutive patients enrolled in an ongoing randomized clinical trial at four sites in Denmark between Jan. 2018 and Jan. 2020. Participants were randomized 1:1 to targeted antipseudomonal antibiotic treatment for 14 days (between visit day 1 and visit day 14) or no antipseudomonal treatment. Sputum samples were collected at baseline on day 1 and on days 14, 30, 60, 90, and 365.
The researchers sequenced isolates from 23 adult patients over 365 days of follow-up. The recurrence of P. aeruginosa occurred in 19 patients (83%) during this period. Ultimately, a total of 153 isolates were analyzed. The researchers found that each patient carried their own unique lineage, with the except of one patient in whom two distinct lineages were identified.
“Independent mutation of the same gene across multiple lineages may be the result of positive selection of adaptive mutations,” Dr. Eklöf and colleagues wrote. They found 38 genes for P. aeruginosa that were mutated in at least two lineages, which suggested adaptive mutations. Some of the more frequently mutated genes were those important to antibiotic resistance and chronic infections, the researchers said. Specifically, mutations occurred in 40 of 140 pathoadaptive genes, compared with 265 of 5,572 other genes (P < .001). In addition, the 24 total lineages carried 4-6 antibiotic resistance genes, and no evidence suggested that lineages acquired or lost these genes during carriage.
Overall, the results indicate that the recurrence of P. aeruginosa was caused by persistence of the same clonal lineage in each patient. “This pattern of persistence was associated with genetic adaptation related to phenotypes considered important for P. aeruginosa infections,” the researchers said.
The study findings were limited by the relatively small number of samples and isolates per sample, the follow-up of only 1 year, and the inability to account for mutations in the early stage because few patients were naive to P. aeruginosa at the start of the study, the researchers noted. However, the results were strengthened by the relatively large and well-defined study population and high rate of sampling compliance, they said.
Overall, “the findings warrant research to improve therapy, including trial data on possible clinical benefits of attempting antibiotic eradication of P. aeruginosa in this vulnerable group of patients,” they concluded.
The study was supported by the Independent Research Fund Denmark and the Research committee at Copenhagen University Hospital-Herlev and Gentofte Hospital. The researchers had no financial conflicts to disclose.
FROM CLINICAL MICROBIOLOGY AND INFECTION
More smoking drives worse outcomes in interstitial lung disease
Heavier smoking significantly increased mortality in adults with progressive fibrosing interstitial lung disease (PF-ILD), based on data from 377 individuals.
The negative impact of smoking on pulmonary diseases is well documented, but the specific impact on patients with PF-ILD has not been well studied, Mark Platenburg, MD, of St. Antonious Hospital, Nieuwegein, the Netherlands, and colleagues wrote in Respiratory Medicine .
“Patients with PF-ILD or IPF [idiopathic pulmonary fibrosis] are prone to early mortality, indicating a need for prognostic [bio]marker studies for precision medicine,” they said.
The researchers identified adults older than 18 years with PF-ILD who were diagnosed at a single center. All study participants had at least 10% fibrosis, and showed either a decline of at least 10% in forced vital capacity, a 5.0%-9.9% relative FVC decline plus progressive respiratory symptoms and/or an increase in extent of fibrosis on subsequent high-resolution (HRCT progression), or progressive respiratory symptoms and HRCT progression over 24 months after ILD diagnosis.
Pack-years of smoking was a prognostic variable; the researchers also compared median transplant-free survival in heavy smokers and mild to moderate smokers. They also investigated the association between smoking quantity and emphysema in the study population.
Overall, the increased risk for mortality was 11%, 22%, and 44% in patients with 10, 20, and 40 pack-years of smoking, respectively.
Both the unadjusted and adjusted hazard ratio for pack-years were significant (1.014, P < .001 and 1.011, P = .022, respectively).
The median transplant-free survival of ever-smokers versus never-smokers with PF-ILD was 3.3 years versus 4.8 years; median transplant-free survival was 3.0 years for heavy smokers and 3.8 years for mild to moderate smokers. Similarly, median survival was 4.2 years in never-smokers versus 3.0 years in former smokers.
Emphysema was significantly more comment in heavy smokers, compared with never smokers and mild to moderate smokers (P < .001 for both).
“We observed a gradual decrease in survival starting from never to mild-moderate and subsequent heavy smokers supporting our finding that [pack-years] is an independent predictor for mortality in PF-ILD,” the researchers wrote. “This is an important message that clinicians could convey to their ILD patients, but also to patients at-risk for ILD.”
The study findings were limited by several factors, mainly the retrospective design, incomplete data for some patients, and lack of data on comorbidities, the researchers noted. However, the results strengthen the evidence for the detrimental effect of heavy smoking in PF-ILD, they said. Consequently, “efforts to reduce pack-years in those with, and at risk for, PF-ILD may translate into a survival benefit and should have high priority in clinical practice.”
The study was supported by grants from ZonMw TopZorg Care and TZO. The researchers had no financial conflicts to disclose.
Heavier smoking significantly increased mortality in adults with progressive fibrosing interstitial lung disease (PF-ILD), based on data from 377 individuals.
The negative impact of smoking on pulmonary diseases is well documented, but the specific impact on patients with PF-ILD has not been well studied, Mark Platenburg, MD, of St. Antonious Hospital, Nieuwegein, the Netherlands, and colleagues wrote in Respiratory Medicine .
“Patients with PF-ILD or IPF [idiopathic pulmonary fibrosis] are prone to early mortality, indicating a need for prognostic [bio]marker studies for precision medicine,” they said.
The researchers identified adults older than 18 years with PF-ILD who were diagnosed at a single center. All study participants had at least 10% fibrosis, and showed either a decline of at least 10% in forced vital capacity, a 5.0%-9.9% relative FVC decline plus progressive respiratory symptoms and/or an increase in extent of fibrosis on subsequent high-resolution (HRCT progression), or progressive respiratory symptoms and HRCT progression over 24 months after ILD diagnosis.
Pack-years of smoking was a prognostic variable; the researchers also compared median transplant-free survival in heavy smokers and mild to moderate smokers. They also investigated the association between smoking quantity and emphysema in the study population.
Overall, the increased risk for mortality was 11%, 22%, and 44% in patients with 10, 20, and 40 pack-years of smoking, respectively.
Both the unadjusted and adjusted hazard ratio for pack-years were significant (1.014, P < .001 and 1.011, P = .022, respectively).
The median transplant-free survival of ever-smokers versus never-smokers with PF-ILD was 3.3 years versus 4.8 years; median transplant-free survival was 3.0 years for heavy smokers and 3.8 years for mild to moderate smokers. Similarly, median survival was 4.2 years in never-smokers versus 3.0 years in former smokers.
Emphysema was significantly more comment in heavy smokers, compared with never smokers and mild to moderate smokers (P < .001 for both).
“We observed a gradual decrease in survival starting from never to mild-moderate and subsequent heavy smokers supporting our finding that [pack-years] is an independent predictor for mortality in PF-ILD,” the researchers wrote. “This is an important message that clinicians could convey to their ILD patients, but also to patients at-risk for ILD.”
The study findings were limited by several factors, mainly the retrospective design, incomplete data for some patients, and lack of data on comorbidities, the researchers noted. However, the results strengthen the evidence for the detrimental effect of heavy smoking in PF-ILD, they said. Consequently, “efforts to reduce pack-years in those with, and at risk for, PF-ILD may translate into a survival benefit and should have high priority in clinical practice.”
The study was supported by grants from ZonMw TopZorg Care and TZO. The researchers had no financial conflicts to disclose.
Heavier smoking significantly increased mortality in adults with progressive fibrosing interstitial lung disease (PF-ILD), based on data from 377 individuals.
The negative impact of smoking on pulmonary diseases is well documented, but the specific impact on patients with PF-ILD has not been well studied, Mark Platenburg, MD, of St. Antonious Hospital, Nieuwegein, the Netherlands, and colleagues wrote in Respiratory Medicine .
“Patients with PF-ILD or IPF [idiopathic pulmonary fibrosis] are prone to early mortality, indicating a need for prognostic [bio]marker studies for precision medicine,” they said.
The researchers identified adults older than 18 years with PF-ILD who were diagnosed at a single center. All study participants had at least 10% fibrosis, and showed either a decline of at least 10% in forced vital capacity, a 5.0%-9.9% relative FVC decline plus progressive respiratory symptoms and/or an increase in extent of fibrosis on subsequent high-resolution (HRCT progression), or progressive respiratory symptoms and HRCT progression over 24 months after ILD diagnosis.
Pack-years of smoking was a prognostic variable; the researchers also compared median transplant-free survival in heavy smokers and mild to moderate smokers. They also investigated the association between smoking quantity and emphysema in the study population.
Overall, the increased risk for mortality was 11%, 22%, and 44% in patients with 10, 20, and 40 pack-years of smoking, respectively.
Both the unadjusted and adjusted hazard ratio for pack-years were significant (1.014, P < .001 and 1.011, P = .022, respectively).
The median transplant-free survival of ever-smokers versus never-smokers with PF-ILD was 3.3 years versus 4.8 years; median transplant-free survival was 3.0 years for heavy smokers and 3.8 years for mild to moderate smokers. Similarly, median survival was 4.2 years in never-smokers versus 3.0 years in former smokers.
Emphysema was significantly more comment in heavy smokers, compared with never smokers and mild to moderate smokers (P < .001 for both).
“We observed a gradual decrease in survival starting from never to mild-moderate and subsequent heavy smokers supporting our finding that [pack-years] is an independent predictor for mortality in PF-ILD,” the researchers wrote. “This is an important message that clinicians could convey to their ILD patients, but also to patients at-risk for ILD.”
The study findings were limited by several factors, mainly the retrospective design, incomplete data for some patients, and lack of data on comorbidities, the researchers noted. However, the results strengthen the evidence for the detrimental effect of heavy smoking in PF-ILD, they said. Consequently, “efforts to reduce pack-years in those with, and at risk for, PF-ILD may translate into a survival benefit and should have high priority in clinical practice.”
The study was supported by grants from ZonMw TopZorg Care and TZO. The researchers had no financial conflicts to disclose.
FROM RESPIRATORY MEDICINE
Double-dose COVID-19 vaccines showed limited effectiveness against Omicron
, as determined on the basis of data from more than 800,000 Omicron-infected individuals.
Early laboratory data suggested a substantially lower neutralizing antibody response to the Omicron variant, compared with both the original COVID-19 strain and the Delta variant, write Nick Andrews, PhD, of the United Kingdom Health Security Agency, London, and colleagues.
Vaccines have shown high levels of effectiveness against symptomatic disease and severe disease and death resulting from the original COVID-19 virus and the Alpha variant and modest effectiveness against the Beta and Delta variants, they say.
“Neutralizing antibodies correlate with protection against reinfection and vaccine effectiveness against infection; therefore, reduced vaccine effectiveness against the omicron variant is anticipated on the basis of these early laboratory findings,” they explain.
In a study published in the New England Journal of Medicine, the researchers identified 886,774 adults aged 18 years and older who had been infected with the Omicron variant, 204,154 who had been infected with the Delta variant, and 1,572,621 symptomatic control patients who tested negative for COVID-19 between Nov. 27, 2021, and Jan. 12, 2022. The participants had been vaccinated with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine, plus a booster given at least 175 days after a second dose, after Sept. 13, 2021.
Vaccine effectiveness was calculated after primary immunization at weeks 2-4, 5-9, 10-14, 15-19, 20-24, and 25 or longer after the second dose, and at 2-4, 5-9, and 10 or more weeks after boosters.
Omicron infections that occurred starting 14 or more days after a booster occurred a median of 39 days after the booster.
“Vaccine effectiveness was lower for the Omicron variant than for the Delta variant at all intervals after vaccination and for all combinations of primary courses and booster doses investigated,” the researchers write.
Individuals who received two doses of ChAdOx1 nCoV-19 had almost no protection against symptomatic disease caused by Omicron from 20-24 weeks after the second dose. For individuals who received two doses of BNT162b2, effectiveness was 65.5% 2-4 weeks after the second dose, but effectiveness declined to 15.4% after 15-19 weeks and to 8.8% after 25 or more weeks. For individuals who received two doses of mRNA-1273, vaccine effectiveness was 75.1% after 2-4 weeks, but effectiveness declined to 14.9% after 25 or more weeks.
Boosters created a short-term improvement in vaccine effectiveness against the Omicron variant, but this effect also declined over time.
Among individuals who received primary doses of ChAdOx1 nCoV-19, vaccine effectiveness increased to 62.4% 2-4 weeks after a BNT162b2 booster, then declined to 39.6% after 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 70.1% at 2-4 weeks and decreased to 60.9% at 5-9 weeks.
Among individuals who received primary doses of BNT162b2, vaccine effectiveness increased to 67.2% 2-4 weeks after a BNT162b2 booster, then declined to 45.7% at 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 73.9% at 2-4 weeks, then declined to 64.4% at 5-9 weeks.
Among individuals who received primary doses of mRNA-1273, vaccine effectiveness increased to 64.9% 2-4 weeks after a BNT162b2 booster and 66.3% 2-4 weeks after an mRNA-1273 booster.
The study findings were limited by potential confounding from study participants who had traveled and may have had different levels of vaccine coverage and by the inability to break down estimates on the basis of age and clinical risk that might affect vaccine effectiveness, the researchers note. Other limitations include a lack of data on vaccine effectiveness for a longer period after boosters, they say.
However, the results are consistent with neutralization data for the Omicron variant in studies from the United Kingdom, South Africa, and Germany, they write. “Our findings support maximizing coverage with third doses of vaccine in highly vaccinated populations such as in the United Kingdom. Further follow-up will be needed to assess protection against severe disease and the duration of protection after booster vaccination,” they conclude.
Focus on severe disease prevention
Paul Offit, MD, of the University of Pennsylvania, Philadelphia, addressed the topic of vaccine effectiveness in an op-ed published on March 4 in The Philadelphia Inquirer. The following is adapted from the op-ed, with his permission.
“The goal of the COVID vaccine – as is true for all vaccines – is to prevent serious illness,” Dr. Offit wrote.
“For most people with normal immune systems, two doses of mRNA vaccines appear to do exactly that. But not everyone,” wrote Dr. Offit, who serves as director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and also serves on the Food and Drug Administration’s Vaccine Advisory Committee. “Three doses are required to induce high levels of protection against serious illness for people over 65 years of age or for people with other conditions that make them vulnerable, which can be anything from being overweight to having cancer. For people who are immune compromised, four doses might be required,” he noted.
Frequent vaccine boosting, although it may help prevent milder cases of COVID-19, such as those seen with the Omicron variant, is impractical, Dr. Offit emphasized. Instead, a newer, variant-specific vaccine might be needed if a variant emerges that overrides the protection against severe disease currently afforded by the available vaccines, he said. “But we’re not there yet. For now, we are going to have to realize that it is virtually impossible to prevent mild COVID without frequent boosting. So, let’s learn to accept that the goal of COVID vaccines is to prevent severe and not mild illness and stop talking about frequent boosting. Otherwise, we will never be able to live our lives as before,” he wrote.
The study was supported by the U.K. Health Security Agency. The researchers and Dr. Offit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, as determined on the basis of data from more than 800,000 Omicron-infected individuals.
Early laboratory data suggested a substantially lower neutralizing antibody response to the Omicron variant, compared with both the original COVID-19 strain and the Delta variant, write Nick Andrews, PhD, of the United Kingdom Health Security Agency, London, and colleagues.
Vaccines have shown high levels of effectiveness against symptomatic disease and severe disease and death resulting from the original COVID-19 virus and the Alpha variant and modest effectiveness against the Beta and Delta variants, they say.
“Neutralizing antibodies correlate with protection against reinfection and vaccine effectiveness against infection; therefore, reduced vaccine effectiveness against the omicron variant is anticipated on the basis of these early laboratory findings,” they explain.
In a study published in the New England Journal of Medicine, the researchers identified 886,774 adults aged 18 years and older who had been infected with the Omicron variant, 204,154 who had been infected with the Delta variant, and 1,572,621 symptomatic control patients who tested negative for COVID-19 between Nov. 27, 2021, and Jan. 12, 2022. The participants had been vaccinated with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine, plus a booster given at least 175 days after a second dose, after Sept. 13, 2021.
Vaccine effectiveness was calculated after primary immunization at weeks 2-4, 5-9, 10-14, 15-19, 20-24, and 25 or longer after the second dose, and at 2-4, 5-9, and 10 or more weeks after boosters.
Omicron infections that occurred starting 14 or more days after a booster occurred a median of 39 days after the booster.
“Vaccine effectiveness was lower for the Omicron variant than for the Delta variant at all intervals after vaccination and for all combinations of primary courses and booster doses investigated,” the researchers write.
Individuals who received two doses of ChAdOx1 nCoV-19 had almost no protection against symptomatic disease caused by Omicron from 20-24 weeks after the second dose. For individuals who received two doses of BNT162b2, effectiveness was 65.5% 2-4 weeks after the second dose, but effectiveness declined to 15.4% after 15-19 weeks and to 8.8% after 25 or more weeks. For individuals who received two doses of mRNA-1273, vaccine effectiveness was 75.1% after 2-4 weeks, but effectiveness declined to 14.9% after 25 or more weeks.
Boosters created a short-term improvement in vaccine effectiveness against the Omicron variant, but this effect also declined over time.
Among individuals who received primary doses of ChAdOx1 nCoV-19, vaccine effectiveness increased to 62.4% 2-4 weeks after a BNT162b2 booster, then declined to 39.6% after 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 70.1% at 2-4 weeks and decreased to 60.9% at 5-9 weeks.
Among individuals who received primary doses of BNT162b2, vaccine effectiveness increased to 67.2% 2-4 weeks after a BNT162b2 booster, then declined to 45.7% at 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 73.9% at 2-4 weeks, then declined to 64.4% at 5-9 weeks.
Among individuals who received primary doses of mRNA-1273, vaccine effectiveness increased to 64.9% 2-4 weeks after a BNT162b2 booster and 66.3% 2-4 weeks after an mRNA-1273 booster.
The study findings were limited by potential confounding from study participants who had traveled and may have had different levels of vaccine coverage and by the inability to break down estimates on the basis of age and clinical risk that might affect vaccine effectiveness, the researchers note. Other limitations include a lack of data on vaccine effectiveness for a longer period after boosters, they say.
However, the results are consistent with neutralization data for the Omicron variant in studies from the United Kingdom, South Africa, and Germany, they write. “Our findings support maximizing coverage with third doses of vaccine in highly vaccinated populations such as in the United Kingdom. Further follow-up will be needed to assess protection against severe disease and the duration of protection after booster vaccination,” they conclude.
Focus on severe disease prevention
Paul Offit, MD, of the University of Pennsylvania, Philadelphia, addressed the topic of vaccine effectiveness in an op-ed published on March 4 in The Philadelphia Inquirer. The following is adapted from the op-ed, with his permission.
“The goal of the COVID vaccine – as is true for all vaccines – is to prevent serious illness,” Dr. Offit wrote.
“For most people with normal immune systems, two doses of mRNA vaccines appear to do exactly that. But not everyone,” wrote Dr. Offit, who serves as director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and also serves on the Food and Drug Administration’s Vaccine Advisory Committee. “Three doses are required to induce high levels of protection against serious illness for people over 65 years of age or for people with other conditions that make them vulnerable, which can be anything from being overweight to having cancer. For people who are immune compromised, four doses might be required,” he noted.
Frequent vaccine boosting, although it may help prevent milder cases of COVID-19, such as those seen with the Omicron variant, is impractical, Dr. Offit emphasized. Instead, a newer, variant-specific vaccine might be needed if a variant emerges that overrides the protection against severe disease currently afforded by the available vaccines, he said. “But we’re not there yet. For now, we are going to have to realize that it is virtually impossible to prevent mild COVID without frequent boosting. So, let’s learn to accept that the goal of COVID vaccines is to prevent severe and not mild illness and stop talking about frequent boosting. Otherwise, we will never be able to live our lives as before,” he wrote.
The study was supported by the U.K. Health Security Agency. The researchers and Dr. Offit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, as determined on the basis of data from more than 800,000 Omicron-infected individuals.
Early laboratory data suggested a substantially lower neutralizing antibody response to the Omicron variant, compared with both the original COVID-19 strain and the Delta variant, write Nick Andrews, PhD, of the United Kingdom Health Security Agency, London, and colleagues.
Vaccines have shown high levels of effectiveness against symptomatic disease and severe disease and death resulting from the original COVID-19 virus and the Alpha variant and modest effectiveness against the Beta and Delta variants, they say.
“Neutralizing antibodies correlate with protection against reinfection and vaccine effectiveness against infection; therefore, reduced vaccine effectiveness against the omicron variant is anticipated on the basis of these early laboratory findings,” they explain.
In a study published in the New England Journal of Medicine, the researchers identified 886,774 adults aged 18 years and older who had been infected with the Omicron variant, 204,154 who had been infected with the Delta variant, and 1,572,621 symptomatic control patients who tested negative for COVID-19 between Nov. 27, 2021, and Jan. 12, 2022. The participants had been vaccinated with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine, plus a booster given at least 175 days after a second dose, after Sept. 13, 2021.
Vaccine effectiveness was calculated after primary immunization at weeks 2-4, 5-9, 10-14, 15-19, 20-24, and 25 or longer after the second dose, and at 2-4, 5-9, and 10 or more weeks after boosters.
Omicron infections that occurred starting 14 or more days after a booster occurred a median of 39 days after the booster.
“Vaccine effectiveness was lower for the Omicron variant than for the Delta variant at all intervals after vaccination and for all combinations of primary courses and booster doses investigated,” the researchers write.
Individuals who received two doses of ChAdOx1 nCoV-19 had almost no protection against symptomatic disease caused by Omicron from 20-24 weeks after the second dose. For individuals who received two doses of BNT162b2, effectiveness was 65.5% 2-4 weeks after the second dose, but effectiveness declined to 15.4% after 15-19 weeks and to 8.8% after 25 or more weeks. For individuals who received two doses of mRNA-1273, vaccine effectiveness was 75.1% after 2-4 weeks, but effectiveness declined to 14.9% after 25 or more weeks.
Boosters created a short-term improvement in vaccine effectiveness against the Omicron variant, but this effect also declined over time.
Among individuals who received primary doses of ChAdOx1 nCoV-19, vaccine effectiveness increased to 62.4% 2-4 weeks after a BNT162b2 booster, then declined to 39.6% after 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 70.1% at 2-4 weeks and decreased to 60.9% at 5-9 weeks.
Among individuals who received primary doses of BNT162b2, vaccine effectiveness increased to 67.2% 2-4 weeks after a BNT162b2 booster, then declined to 45.7% at 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 73.9% at 2-4 weeks, then declined to 64.4% at 5-9 weeks.
Among individuals who received primary doses of mRNA-1273, vaccine effectiveness increased to 64.9% 2-4 weeks after a BNT162b2 booster and 66.3% 2-4 weeks after an mRNA-1273 booster.
The study findings were limited by potential confounding from study participants who had traveled and may have had different levels of vaccine coverage and by the inability to break down estimates on the basis of age and clinical risk that might affect vaccine effectiveness, the researchers note. Other limitations include a lack of data on vaccine effectiveness for a longer period after boosters, they say.
However, the results are consistent with neutralization data for the Omicron variant in studies from the United Kingdom, South Africa, and Germany, they write. “Our findings support maximizing coverage with third doses of vaccine in highly vaccinated populations such as in the United Kingdom. Further follow-up will be needed to assess protection against severe disease and the duration of protection after booster vaccination,” they conclude.
Focus on severe disease prevention
Paul Offit, MD, of the University of Pennsylvania, Philadelphia, addressed the topic of vaccine effectiveness in an op-ed published on March 4 in The Philadelphia Inquirer. The following is adapted from the op-ed, with his permission.
“The goal of the COVID vaccine – as is true for all vaccines – is to prevent serious illness,” Dr. Offit wrote.
“For most people with normal immune systems, two doses of mRNA vaccines appear to do exactly that. But not everyone,” wrote Dr. Offit, who serves as director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and also serves on the Food and Drug Administration’s Vaccine Advisory Committee. “Three doses are required to induce high levels of protection against serious illness for people over 65 years of age or for people with other conditions that make them vulnerable, which can be anything from being overweight to having cancer. For people who are immune compromised, four doses might be required,” he noted.
Frequent vaccine boosting, although it may help prevent milder cases of COVID-19, such as those seen with the Omicron variant, is impractical, Dr. Offit emphasized. Instead, a newer, variant-specific vaccine might be needed if a variant emerges that overrides the protection against severe disease currently afforded by the available vaccines, he said. “But we’re not there yet. For now, we are going to have to realize that it is virtually impossible to prevent mild COVID without frequent boosting. So, let’s learn to accept that the goal of COVID vaccines is to prevent severe and not mild illness and stop talking about frequent boosting. Otherwise, we will never be able to live our lives as before,” he wrote.
The study was supported by the U.K. Health Security Agency. The researchers and Dr. Offit have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Screening with a tablet-based app elicits sensitive information in primary care
“Anyone who has been to a doctor’s office recently realizes that everyone there is very busy,” said David P. Miller Jr., MD, lead author of the paper published in JAMA Network Open, in an interview. “For our study, we programmed routine screening questions that nursing staff were asking at every visit into an app [called mPATH] that patients used on check-in.”
In particular, screening for depression, injurious falls, or intimate partner violence in a primary care setting is hampered not only by time constraints, but also staff discomfort and patients’ reluctance to disclose sensitive information, Dr. Miller of Wake Forest University, Winston-Salem, N.C., and colleagues explained in their paper.
Study methods and results
The researchers tested the app in three family practices and three internal medicine practices. They compared whether more patients were identified with depression, intimate partner violence, or fall risk in the 60 days of using the tablet-based app, compared with the 60-day period before introduction of the app, when nursing staff asked screening questions verbally. Patients were given the tablet and app to use at check-in, and results went into an electronic health record.
The study population included 23,026 individuals, aged 18 years and older who were seen between June 2019 and February 2020.
The post-app period was shortened to 30 days for the last two enrolled practices to avoid confounding from COVID-19, the researchers noted.
The primary outcome of the study was the proportion of patients who screened positive for a composite of depression, fall risk, or intimate partner violence.
“We found that [the app] significantly outperformed nursing staff in terms of detecting patients with depression or safety concerns,” Dr. Miller said in an interview. “By saving nurses time, we hope they can use the saved time to address patients’ identified concerns.”
Overall, the proportion of patients who screened positive for the composite outcome of depression, fall risk, or intimate partner violence increased from 8.7% to 19.5%. Increases were noted across all six participating clinics.
When broken out separately, the proportion of patients who screened positive for depression, based on Patient Health Questionnaire-2 scores of 2 or higher, increased from 1.5% to 4.2% from before to after the introduction of the tablet-based app. The proportion of patients screening positive for fall risk increased from 7.4% to 15.7%, and the proportion who screened positive for intimate partner violence increased from 0.1% to 2.9%.
Patient demographics were similar for the two time periods. Overall, 57.9% of patients were female, 80.5% were non-Hispanic White, and 13.5% were Black or African American. Patients ranged in age from 18-102 years, with a mean age of 59.7 years.
The association of app use on the primary outcome remained the same (adjusted odds ratio, 2.6) after accounting for patient characteristics.
Real-world setting supports clinical value
“One of the strengths of our study is that the mPATH app was delivered as usual care in the primary care clinics,” Dr. Miller said in an interview. “In other words, we relied entirely on clinical staff to hand the app to patients and transmit the screening results to the electronic health record. This allowed us to see how self-administered screening performs in the real world rather than in a research setting,” he said. “Another strength is our large sample size. We included more than 23,000 patients who were seen at one of six community-based primary care practices.”
“A few other studies have compared electronic self-administered screening with verbal screening, mainly in the areas of intimate partner violence or sexual health,” Dr. Miller noted. “However, these studies were administered by research staff and only included patients agreeing to be in a research study, which leaves many people out. What makes our study unique is that the primary care practices were using the self-screening app as part of their routine care,” he said.
“By analyzing deidentified data, we could see how self-administered screening compares to verbal screening among all patients in a real-world setting,” he added.
“We found that self-administered screening significantly outperforms verbal screening by clinical staff. Over twice as many patients with depression, fall risk, or intimate partner violence were identified by the app, compared to verbal screening,” said Dr. Miller. “We hope that clinics will look for ways to incorporate electronic self-screening in their usual processes. Self-administered screening not only saves staff time, but it does a much better job identifying patients with needs,” he said.
“The next step will be identifying the best way to incorporate digital health apps like mPATH into usual workflows,” Dr. Miller said. “We are currently conducting an implementation science trial of the mPATH app to learn this.”
App allows patients privacy in responses
“The study is important for assessing the physical and mental well-being of patients at all health care practices in general and in primary care practices in particular, said Noel Deep, MD, a general internist in group practice in Antigo, Wisc., in an interview. “This study provides the data that can be leveraged to provide this type of virtual or electronic options for patients to answer these sensitive questions,” he said.
“It provides them the opportunity to answer the questions truthfully and without fear of being judged by the staff who traditionally ask these questions,” he emphasized.
Dr. Deep was not surprised by the study outcomes.
“Almost all primary care practices administer these questionnaires to their patients, whether at their annual wellness exams or the Medicare wellness exams,” he said. “Many times, the staff asking these questions might introduce some of their personal bias or not ask the questions in a nonjudgmental manner, which may not elicit the right answers from the patients.”
The clinical value of the study is that it prompts physicians and health care organizations to consider adopting other modalities to collect screening information “that is comfortable to the patients, reproducible, patient-friendly, easily accessed by the patients and reviewable by their physicians, and, more importantly is private and maintains patient confidentiality,” said Dr. Deep.
Study needs to be replicated in rural, small communities
“I would like to see the study done among more diverse ethnic, age, socioeconomic, education, geographic, and physician practice–size populations,” which would reinforce the value of the tablet-based app if such studies yielded similar results, Dr. Deep said.
Privacy is especially important for practices in smaller communities/rural communities, such as the one where Dr. Deep practices, as everyone knows everyone in these kinds of places, he said.
“I understand that we are all sworn to maintaining patient confidentiality, but that may not be what the patients perceive. That is why I would like to see what the study finds in rural or small communities,” Dr. Deep explained.
The study was supported by the National Cancer Institute. Dr. Miller and coauthor Dr. Ajay Dharod are the coinventors of the mPATH app, and they and Wake Forest University Health Sciences have an ownership interest should the app be commercialized. Dr. Deep had no financial conflicts to disclose.
“Anyone who has been to a doctor’s office recently realizes that everyone there is very busy,” said David P. Miller Jr., MD, lead author of the paper published in JAMA Network Open, in an interview. “For our study, we programmed routine screening questions that nursing staff were asking at every visit into an app [called mPATH] that patients used on check-in.”
In particular, screening for depression, injurious falls, or intimate partner violence in a primary care setting is hampered not only by time constraints, but also staff discomfort and patients’ reluctance to disclose sensitive information, Dr. Miller of Wake Forest University, Winston-Salem, N.C., and colleagues explained in their paper.
Study methods and results
The researchers tested the app in three family practices and three internal medicine practices. They compared whether more patients were identified with depression, intimate partner violence, or fall risk in the 60 days of using the tablet-based app, compared with the 60-day period before introduction of the app, when nursing staff asked screening questions verbally. Patients were given the tablet and app to use at check-in, and results went into an electronic health record.
The study population included 23,026 individuals, aged 18 years and older who were seen between June 2019 and February 2020.
The post-app period was shortened to 30 days for the last two enrolled practices to avoid confounding from COVID-19, the researchers noted.
The primary outcome of the study was the proportion of patients who screened positive for a composite of depression, fall risk, or intimate partner violence.
“We found that [the app] significantly outperformed nursing staff in terms of detecting patients with depression or safety concerns,” Dr. Miller said in an interview. “By saving nurses time, we hope they can use the saved time to address patients’ identified concerns.”
Overall, the proportion of patients who screened positive for the composite outcome of depression, fall risk, or intimate partner violence increased from 8.7% to 19.5%. Increases were noted across all six participating clinics.
When broken out separately, the proportion of patients who screened positive for depression, based on Patient Health Questionnaire-2 scores of 2 or higher, increased from 1.5% to 4.2% from before to after the introduction of the tablet-based app. The proportion of patients screening positive for fall risk increased from 7.4% to 15.7%, and the proportion who screened positive for intimate partner violence increased from 0.1% to 2.9%.
Patient demographics were similar for the two time periods. Overall, 57.9% of patients were female, 80.5% were non-Hispanic White, and 13.5% were Black or African American. Patients ranged in age from 18-102 years, with a mean age of 59.7 years.
The association of app use on the primary outcome remained the same (adjusted odds ratio, 2.6) after accounting for patient characteristics.
Real-world setting supports clinical value
“One of the strengths of our study is that the mPATH app was delivered as usual care in the primary care clinics,” Dr. Miller said in an interview. “In other words, we relied entirely on clinical staff to hand the app to patients and transmit the screening results to the electronic health record. This allowed us to see how self-administered screening performs in the real world rather than in a research setting,” he said. “Another strength is our large sample size. We included more than 23,000 patients who were seen at one of six community-based primary care practices.”
“A few other studies have compared electronic self-administered screening with verbal screening, mainly in the areas of intimate partner violence or sexual health,” Dr. Miller noted. “However, these studies were administered by research staff and only included patients agreeing to be in a research study, which leaves many people out. What makes our study unique is that the primary care practices were using the self-screening app as part of their routine care,” he said.
“By analyzing deidentified data, we could see how self-administered screening compares to verbal screening among all patients in a real-world setting,” he added.
“We found that self-administered screening significantly outperforms verbal screening by clinical staff. Over twice as many patients with depression, fall risk, or intimate partner violence were identified by the app, compared to verbal screening,” said Dr. Miller. “We hope that clinics will look for ways to incorporate electronic self-screening in their usual processes. Self-administered screening not only saves staff time, but it does a much better job identifying patients with needs,” he said.
“The next step will be identifying the best way to incorporate digital health apps like mPATH into usual workflows,” Dr. Miller said. “We are currently conducting an implementation science trial of the mPATH app to learn this.”
App allows patients privacy in responses
“The study is important for assessing the physical and mental well-being of patients at all health care practices in general and in primary care practices in particular, said Noel Deep, MD, a general internist in group practice in Antigo, Wisc., in an interview. “This study provides the data that can be leveraged to provide this type of virtual or electronic options for patients to answer these sensitive questions,” he said.
“It provides them the opportunity to answer the questions truthfully and without fear of being judged by the staff who traditionally ask these questions,” he emphasized.
Dr. Deep was not surprised by the study outcomes.
“Almost all primary care practices administer these questionnaires to their patients, whether at their annual wellness exams or the Medicare wellness exams,” he said. “Many times, the staff asking these questions might introduce some of their personal bias or not ask the questions in a nonjudgmental manner, which may not elicit the right answers from the patients.”
The clinical value of the study is that it prompts physicians and health care organizations to consider adopting other modalities to collect screening information “that is comfortable to the patients, reproducible, patient-friendly, easily accessed by the patients and reviewable by their physicians, and, more importantly is private and maintains patient confidentiality,” said Dr. Deep.
Study needs to be replicated in rural, small communities
“I would like to see the study done among more diverse ethnic, age, socioeconomic, education, geographic, and physician practice–size populations,” which would reinforce the value of the tablet-based app if such studies yielded similar results, Dr. Deep said.
Privacy is especially important for practices in smaller communities/rural communities, such as the one where Dr. Deep practices, as everyone knows everyone in these kinds of places, he said.
“I understand that we are all sworn to maintaining patient confidentiality, but that may not be what the patients perceive. That is why I would like to see what the study finds in rural or small communities,” Dr. Deep explained.
The study was supported by the National Cancer Institute. Dr. Miller and coauthor Dr. Ajay Dharod are the coinventors of the mPATH app, and they and Wake Forest University Health Sciences have an ownership interest should the app be commercialized. Dr. Deep had no financial conflicts to disclose.
“Anyone who has been to a doctor’s office recently realizes that everyone there is very busy,” said David P. Miller Jr., MD, lead author of the paper published in JAMA Network Open, in an interview. “For our study, we programmed routine screening questions that nursing staff were asking at every visit into an app [called mPATH] that patients used on check-in.”
In particular, screening for depression, injurious falls, or intimate partner violence in a primary care setting is hampered not only by time constraints, but also staff discomfort and patients’ reluctance to disclose sensitive information, Dr. Miller of Wake Forest University, Winston-Salem, N.C., and colleagues explained in their paper.
Study methods and results
The researchers tested the app in three family practices and three internal medicine practices. They compared whether more patients were identified with depression, intimate partner violence, or fall risk in the 60 days of using the tablet-based app, compared with the 60-day period before introduction of the app, when nursing staff asked screening questions verbally. Patients were given the tablet and app to use at check-in, and results went into an electronic health record.
The study population included 23,026 individuals, aged 18 years and older who were seen between June 2019 and February 2020.
The post-app period was shortened to 30 days for the last two enrolled practices to avoid confounding from COVID-19, the researchers noted.
The primary outcome of the study was the proportion of patients who screened positive for a composite of depression, fall risk, or intimate partner violence.
“We found that [the app] significantly outperformed nursing staff in terms of detecting patients with depression or safety concerns,” Dr. Miller said in an interview. “By saving nurses time, we hope they can use the saved time to address patients’ identified concerns.”
Overall, the proportion of patients who screened positive for the composite outcome of depression, fall risk, or intimate partner violence increased from 8.7% to 19.5%. Increases were noted across all six participating clinics.
When broken out separately, the proportion of patients who screened positive for depression, based on Patient Health Questionnaire-2 scores of 2 or higher, increased from 1.5% to 4.2% from before to after the introduction of the tablet-based app. The proportion of patients screening positive for fall risk increased from 7.4% to 15.7%, and the proportion who screened positive for intimate partner violence increased from 0.1% to 2.9%.
Patient demographics were similar for the two time periods. Overall, 57.9% of patients were female, 80.5% were non-Hispanic White, and 13.5% were Black or African American. Patients ranged in age from 18-102 years, with a mean age of 59.7 years.
The association of app use on the primary outcome remained the same (adjusted odds ratio, 2.6) after accounting for patient characteristics.
Real-world setting supports clinical value
“One of the strengths of our study is that the mPATH app was delivered as usual care in the primary care clinics,” Dr. Miller said in an interview. “In other words, we relied entirely on clinical staff to hand the app to patients and transmit the screening results to the electronic health record. This allowed us to see how self-administered screening performs in the real world rather than in a research setting,” he said. “Another strength is our large sample size. We included more than 23,000 patients who were seen at one of six community-based primary care practices.”
“A few other studies have compared electronic self-administered screening with verbal screening, mainly in the areas of intimate partner violence or sexual health,” Dr. Miller noted. “However, these studies were administered by research staff and only included patients agreeing to be in a research study, which leaves many people out. What makes our study unique is that the primary care practices were using the self-screening app as part of their routine care,” he said.
“By analyzing deidentified data, we could see how self-administered screening compares to verbal screening among all patients in a real-world setting,” he added.
“We found that self-administered screening significantly outperforms verbal screening by clinical staff. Over twice as many patients with depression, fall risk, or intimate partner violence were identified by the app, compared to verbal screening,” said Dr. Miller. “We hope that clinics will look for ways to incorporate electronic self-screening in their usual processes. Self-administered screening not only saves staff time, but it does a much better job identifying patients with needs,” he said.
“The next step will be identifying the best way to incorporate digital health apps like mPATH into usual workflows,” Dr. Miller said. “We are currently conducting an implementation science trial of the mPATH app to learn this.”
App allows patients privacy in responses
“The study is important for assessing the physical and mental well-being of patients at all health care practices in general and in primary care practices in particular, said Noel Deep, MD, a general internist in group practice in Antigo, Wisc., in an interview. “This study provides the data that can be leveraged to provide this type of virtual or electronic options for patients to answer these sensitive questions,” he said.
“It provides them the opportunity to answer the questions truthfully and without fear of being judged by the staff who traditionally ask these questions,” he emphasized.
Dr. Deep was not surprised by the study outcomes.
“Almost all primary care practices administer these questionnaires to their patients, whether at their annual wellness exams or the Medicare wellness exams,” he said. “Many times, the staff asking these questions might introduce some of their personal bias or not ask the questions in a nonjudgmental manner, which may not elicit the right answers from the patients.”
The clinical value of the study is that it prompts physicians and health care organizations to consider adopting other modalities to collect screening information “that is comfortable to the patients, reproducible, patient-friendly, easily accessed by the patients and reviewable by their physicians, and, more importantly is private and maintains patient confidentiality,” said Dr. Deep.
Study needs to be replicated in rural, small communities
“I would like to see the study done among more diverse ethnic, age, socioeconomic, education, geographic, and physician practice–size populations,” which would reinforce the value of the tablet-based app if such studies yielded similar results, Dr. Deep said.
Privacy is especially important for practices in smaller communities/rural communities, such as the one where Dr. Deep practices, as everyone knows everyone in these kinds of places, he said.
“I understand that we are all sworn to maintaining patient confidentiality, but that may not be what the patients perceive. That is why I would like to see what the study finds in rural or small communities,” Dr. Deep explained.
The study was supported by the National Cancer Institute. Dr. Miller and coauthor Dr. Ajay Dharod are the coinventors of the mPATH app, and they and Wake Forest University Health Sciences have an ownership interest should the app be commercialized. Dr. Deep had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Hair loss affects more than half of postmenopausal women
Female-pattern hair loss (FPHL) was identified in 52% of postmenopausal women, and 4% of these cases involved extensive baldness, based on data from 178 individuals.
FPHL can develop at any time from teenage years through and beyond menopause, wrote Sukanya Chaikittisilpa, MD, of Chulalongkorn University, Bangkok, and colleagues.
The cause of FPHL remains uncertain, but the presence of estrogen receptors in hair follicles suggests that the hormone changes of menopause may affect hair growth, the researchers said.
In a study published in Menopause, the researchers evaluated 178 postmenopausal women aged 50-65 years for FPHL. FPLH was determined based on photographs and on measures of hormone levels, hair density, and hair diameter.
The overall prevalence of FPHL was 52.2%. The hair loss was divided into three categories indicating mild, moderate, and severe (Ludwig grades I, II, and III) with prevalence of 73.2%, 22.6%, and 4.3%, respectively. The prevalence of FPHL also increased with age and time since menopause. In a simple logistic regression analysis, age 56 years and older and more than 6 years since menopause were significantly associated with FPHL (odds ratios, 3.41 and 1.98, respectively).
However, after adjustment for multiple variables, only a body mass index of 25 kg/m2 or higher also was associated with increased prevalence of FPHL (adjusted OR, 2.65).
A total of 60% of the study participants met criteria for low self-esteem, including all the women in the severe hair loss category.
“The postmenopausal women with FPHL in our cohort had lower total hair density, terminal hair density, hair thickness, hair unit density, and average hair per unit than those with normal hair patterns,” although vellus hair density was higher in women with FPHL, the researchers wrote in their discussion of the findings. This distinction may be caused in part by the shortened hair cycle and reduced anagen phase of velluslike follicles, they said.
The study findings were limited by several factors, including the cross-sectional design and the inclusion of only women from a single menopause clinic, which may not reflect FPHL in the general population, as well as the reliance on patients’ recall, the researchers noted. Another limitation was the inability to assess postmenopausal hormone levels, they added.
However, “This study may be the first FPHL study conducted in a menopause clinic that targeted only healthy postmenopausal women,” they wrote. More research is needed to determine the potential role of estrogen and testosterone on FPHL in postmenopausal women, and whether a history of polycystic ovarian syndrome has an effect, they said. Meanwhile, current study results may help clinicians and patients determine the most appropriate menopausal hormone therapies for postmenopausal women with FPHL, they concluded.
Consider lifestyle and self-esteem issues
The current study is important at this time because a larger proportion of women are either reaching menopause or are menopausal, said Constance Bohon, MD, a gynecologist in private practice in Washington, in an interview.
“Whatever we in the medical community can do to help women transition into the menopausal years with the least anxiety is important,” including helping women feel comfortable about their appearance, she said.
“For women in the peri- and postmenopausal years, hair loss is a relatively common concern,” Dr. Bohon said. However, in the current study, “I was surprised that it was associated with low self-esteem and obesity,” she noted. “For these women, it would be interesting to know whether they also had concerns about the appearance of their bodies, or just their hair loss,” she said. The question is whether the hair loss in and of itself caused low self-esteem in the study population, or whether it exacerbated their already poor self-assessment, Dr. Bohon said. “Another consideration is that perhaps these women were already feeling the effects of aging and were trying to change their appearance by using hair dyes, and now they find themselves losing hair as well,” she noted.
The takeaway message for clinicians is that discussions with perimenopausal and postmenopausal women should include the topic of hair loss along with hot flashes and night sweats, said Dr. Bohon.
Women who are experiencing hair loss or concerned about the possibility of hair loss should ask their doctors about possible interventions that may mitigate or prevent further hair loss, she said.
As for additional research, “the most important issue is to determine the factors that are associated with hair loss in the perimenopausal and postmenopausal years,” Dr. Bohon said. Research questions should include impact of dyeing or straightening hair on the likelihood of hair loss, and whether women with more severe hot flashes/night sweats and/or sleeplessness have more hair loss than women who do not experience any of the symptoms as they go through menopause, she emphasized.
Other considerations are whether certain diets or foods are more common among women who have more hair loss, and whether weight loss into a normal range or weight gain into a body mass index greater than 25 kg/m2 affects hair loss, said Dr. Bohon. Also, don’t discount the impact of stress, and whether women who have lost hair identify certain stressful times that preceded their hair loss, as well as what medications could be associated with hair loss, and whether hormone therapy might prevent hair loss, she said.
The study was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
Female-pattern hair loss (FPHL) was identified in 52% of postmenopausal women, and 4% of these cases involved extensive baldness, based on data from 178 individuals.
FPHL can develop at any time from teenage years through and beyond menopause, wrote Sukanya Chaikittisilpa, MD, of Chulalongkorn University, Bangkok, and colleagues.
The cause of FPHL remains uncertain, but the presence of estrogen receptors in hair follicles suggests that the hormone changes of menopause may affect hair growth, the researchers said.
In a study published in Menopause, the researchers evaluated 178 postmenopausal women aged 50-65 years for FPHL. FPLH was determined based on photographs and on measures of hormone levels, hair density, and hair diameter.
The overall prevalence of FPHL was 52.2%. The hair loss was divided into three categories indicating mild, moderate, and severe (Ludwig grades I, II, and III) with prevalence of 73.2%, 22.6%, and 4.3%, respectively. The prevalence of FPHL also increased with age and time since menopause. In a simple logistic regression analysis, age 56 years and older and more than 6 years since menopause were significantly associated with FPHL (odds ratios, 3.41 and 1.98, respectively).
However, after adjustment for multiple variables, only a body mass index of 25 kg/m2 or higher also was associated with increased prevalence of FPHL (adjusted OR, 2.65).
A total of 60% of the study participants met criteria for low self-esteem, including all the women in the severe hair loss category.
“The postmenopausal women with FPHL in our cohort had lower total hair density, terminal hair density, hair thickness, hair unit density, and average hair per unit than those with normal hair patterns,” although vellus hair density was higher in women with FPHL, the researchers wrote in their discussion of the findings. This distinction may be caused in part by the shortened hair cycle and reduced anagen phase of velluslike follicles, they said.
The study findings were limited by several factors, including the cross-sectional design and the inclusion of only women from a single menopause clinic, which may not reflect FPHL in the general population, as well as the reliance on patients’ recall, the researchers noted. Another limitation was the inability to assess postmenopausal hormone levels, they added.
However, “This study may be the first FPHL study conducted in a menopause clinic that targeted only healthy postmenopausal women,” they wrote. More research is needed to determine the potential role of estrogen and testosterone on FPHL in postmenopausal women, and whether a history of polycystic ovarian syndrome has an effect, they said. Meanwhile, current study results may help clinicians and patients determine the most appropriate menopausal hormone therapies for postmenopausal women with FPHL, they concluded.
Consider lifestyle and self-esteem issues
The current study is important at this time because a larger proportion of women are either reaching menopause or are menopausal, said Constance Bohon, MD, a gynecologist in private practice in Washington, in an interview.
“Whatever we in the medical community can do to help women transition into the menopausal years with the least anxiety is important,” including helping women feel comfortable about their appearance, she said.
“For women in the peri- and postmenopausal years, hair loss is a relatively common concern,” Dr. Bohon said. However, in the current study, “I was surprised that it was associated with low self-esteem and obesity,” she noted. “For these women, it would be interesting to know whether they also had concerns about the appearance of their bodies, or just their hair loss,” she said. The question is whether the hair loss in and of itself caused low self-esteem in the study population, or whether it exacerbated their already poor self-assessment, Dr. Bohon said. “Another consideration is that perhaps these women were already feeling the effects of aging and were trying to change their appearance by using hair dyes, and now they find themselves losing hair as well,” she noted.
The takeaway message for clinicians is that discussions with perimenopausal and postmenopausal women should include the topic of hair loss along with hot flashes and night sweats, said Dr. Bohon.
Women who are experiencing hair loss or concerned about the possibility of hair loss should ask their doctors about possible interventions that may mitigate or prevent further hair loss, she said.
As for additional research, “the most important issue is to determine the factors that are associated with hair loss in the perimenopausal and postmenopausal years,” Dr. Bohon said. Research questions should include impact of dyeing or straightening hair on the likelihood of hair loss, and whether women with more severe hot flashes/night sweats and/or sleeplessness have more hair loss than women who do not experience any of the symptoms as they go through menopause, she emphasized.
Other considerations are whether certain diets or foods are more common among women who have more hair loss, and whether weight loss into a normal range or weight gain into a body mass index greater than 25 kg/m2 affects hair loss, said Dr. Bohon. Also, don’t discount the impact of stress, and whether women who have lost hair identify certain stressful times that preceded their hair loss, as well as what medications could be associated with hair loss, and whether hormone therapy might prevent hair loss, she said.
The study was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
Female-pattern hair loss (FPHL) was identified in 52% of postmenopausal women, and 4% of these cases involved extensive baldness, based on data from 178 individuals.
FPHL can develop at any time from teenage years through and beyond menopause, wrote Sukanya Chaikittisilpa, MD, of Chulalongkorn University, Bangkok, and colleagues.
The cause of FPHL remains uncertain, but the presence of estrogen receptors in hair follicles suggests that the hormone changes of menopause may affect hair growth, the researchers said.
In a study published in Menopause, the researchers evaluated 178 postmenopausal women aged 50-65 years for FPHL. FPLH was determined based on photographs and on measures of hormone levels, hair density, and hair diameter.
The overall prevalence of FPHL was 52.2%. The hair loss was divided into three categories indicating mild, moderate, and severe (Ludwig grades I, II, and III) with prevalence of 73.2%, 22.6%, and 4.3%, respectively. The prevalence of FPHL also increased with age and time since menopause. In a simple logistic regression analysis, age 56 years and older and more than 6 years since menopause were significantly associated with FPHL (odds ratios, 3.41 and 1.98, respectively).
However, after adjustment for multiple variables, only a body mass index of 25 kg/m2 or higher also was associated with increased prevalence of FPHL (adjusted OR, 2.65).
A total of 60% of the study participants met criteria for low self-esteem, including all the women in the severe hair loss category.
“The postmenopausal women with FPHL in our cohort had lower total hair density, terminal hair density, hair thickness, hair unit density, and average hair per unit than those with normal hair patterns,” although vellus hair density was higher in women with FPHL, the researchers wrote in their discussion of the findings. This distinction may be caused in part by the shortened hair cycle and reduced anagen phase of velluslike follicles, they said.
The study findings were limited by several factors, including the cross-sectional design and the inclusion of only women from a single menopause clinic, which may not reflect FPHL in the general population, as well as the reliance on patients’ recall, the researchers noted. Another limitation was the inability to assess postmenopausal hormone levels, they added.
However, “This study may be the first FPHL study conducted in a menopause clinic that targeted only healthy postmenopausal women,” they wrote. More research is needed to determine the potential role of estrogen and testosterone on FPHL in postmenopausal women, and whether a history of polycystic ovarian syndrome has an effect, they said. Meanwhile, current study results may help clinicians and patients determine the most appropriate menopausal hormone therapies for postmenopausal women with FPHL, they concluded.
Consider lifestyle and self-esteem issues
The current study is important at this time because a larger proportion of women are either reaching menopause or are menopausal, said Constance Bohon, MD, a gynecologist in private practice in Washington, in an interview.
“Whatever we in the medical community can do to help women transition into the menopausal years with the least anxiety is important,” including helping women feel comfortable about their appearance, she said.
“For women in the peri- and postmenopausal years, hair loss is a relatively common concern,” Dr. Bohon said. However, in the current study, “I was surprised that it was associated with low self-esteem and obesity,” she noted. “For these women, it would be interesting to know whether they also had concerns about the appearance of their bodies, or just their hair loss,” she said. The question is whether the hair loss in and of itself caused low self-esteem in the study population, or whether it exacerbated their already poor self-assessment, Dr. Bohon said. “Another consideration is that perhaps these women were already feeling the effects of aging and were trying to change their appearance by using hair dyes, and now they find themselves losing hair as well,” she noted.
The takeaway message for clinicians is that discussions with perimenopausal and postmenopausal women should include the topic of hair loss along with hot flashes and night sweats, said Dr. Bohon.
Women who are experiencing hair loss or concerned about the possibility of hair loss should ask their doctors about possible interventions that may mitigate or prevent further hair loss, she said.
As for additional research, “the most important issue is to determine the factors that are associated with hair loss in the perimenopausal and postmenopausal years,” Dr. Bohon said. Research questions should include impact of dyeing or straightening hair on the likelihood of hair loss, and whether women with more severe hot flashes/night sweats and/or sleeplessness have more hair loss than women who do not experience any of the symptoms as they go through menopause, she emphasized.
Other considerations are whether certain diets or foods are more common among women who have more hair loss, and whether weight loss into a normal range or weight gain into a body mass index greater than 25 kg/m2 affects hair loss, said Dr. Bohon. Also, don’t discount the impact of stress, and whether women who have lost hair identify certain stressful times that preceded their hair loss, as well as what medications could be associated with hair loss, and whether hormone therapy might prevent hair loss, she said.
The study was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
FROM MENOPAUSE
Tremors and memory loss precede Parkinson’s in diverse population
Tremors and memory symptoms were identified among individuals in a primary care setting as early as 10 years before a Parkinson’s disease diagnosis in a new study.
Most research on the causes and early signs of Parkinson’s disease (PD) have involved patients of Northern European ancestry, Cristina Simonet, MD, of Queen Mary University of London, and colleagues wrote in their paper, published in JAMA Neurology.
Additionally, data on how PD might manifest in different ethnic groups are limited, they said.
In their nested case-control, the researchers examined data from electronic health records of an ethnically diverse population of 1,016,277 adults seen in primary care practices between 1990 and Feb. 6, 2018. They compared individuals with PD with those without PD or other neurologic conditions.
The researchers identified 10 age and sex-matched controls for each PD case, and also conducted an unmatched analysis after adjusting for age and sex. The final study population included 1,055 patients with PD and 1,009,523 controls. The population of PD cases was 15.7% Black, 19.7% South Asian, 50.9% White, and 8.3% other; the population of controls was 13.3% Black, 21.5% South Asian, 43.7% White, and 11.3% other.
“We observed a constellation of symptoms noted by general practitioners up to a decade before diagnosis of PD,” the researchers said. Symptoms were identified across three time intervals (less than 2 years, 2-5 years, and 5-10 years before diagnosis) to better evaluate exposure outcome associations.
In the matched analysis of midlife risk factors, epilepsy showed the strongest association with PD diagnosis across all time periods, and type 2 diabetes or hypertension 5-10 years before diagnosis was associated with later PD.
Prediagnostic signs of PD included both motor and nonmotor manifestations.
The matched analysis revealed a significant increased association between tremor and memory symptoms less than 2 years before diagnosis (adjusted odds ratios of 151.24 and 8.73, respectively) as well as up to 10 years before diagnosis for tremors and up to 5 years for memory symptoms (aOR, 11.4 and 3.09, respectively) in PD patients, compared with controls.
Other strong associations between PD and early nonmotor features in cases, compared with controls, included hypotension (aOR, 6.81), constipation (aOR, 3.29), and depression (aOR, 4.61).
In addition, the researchers found associations for epilepsy that had not been identified in previous studies, and these associations persisted in a replication analysis.
The study findings were limited by several factors, mainly the use of routine primary care data with underascertained factors of interest, and potential mislabeling of PD, the researchers noted. Other limitations included the lack of data on prescription medication for PD, and the recording of memory problems in primary care without supportive testing to confirm cognitive impairment.
The results support a range of comorbidities and symptoms that may present in primary care, and clinicians should consider PD as a possible cause, the researchers wrote.
Make early referral a priority
The study is important because of the lack of diversity in Parkinson’s disease research, lead author Dr. Simonet said in an interview.
“Over the last decade, the global population suffering from Parkinson’s disease has more than doubled,” she said. Causes may include the increasing numbers of older people with longer life expectancy. “However, it seems there are other factors, including environmental, genetic, and lifestyle, that might play a role in increasing the prevalence of Parkinson’s disease.”
“More representative studies, including minority ethnic groups and those living in areas of high social and economic deprivation, are needed,” Dr. Simonet emphasized.
She said that there is little research on the association with epilepsy and hearing loss in early PD, and “for that reason, our results should encourage further studies to confirm a possible link between these manifestations and Parkinson’s disease.”
Early detection may drive better diagnoses
The current study is important for understanding the prediagnostic features and risk factors that may allow for earlier detection of Parkinson’s disease, William Hung, MD, a geriatrics and palliative care specialist of the Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Prior to this study, there was limited understanding of these features.
“One surprise [in the findings] was that ethnicity and socioeconomic deprivation do not appear to be associated with the risk of PD, in contrast to other illnesses such as dementia,” said Dr. Hung. “The array of prediagnostic features associated with PD is not surprising, but nonetheless important for clinicians to know to consider whether PD could be the underlying cause.”
The take-home message for primary care is that “there are features, such as hearing loss, history of epilepsy, autonomic symptoms, motor symptoms, among others, for which clinicians should consider PD as part of the differential diagnosis as underlying cause and consider referral to specialists for diagnostic clarification,” said Dr. Hung.
“Additional research is needed to translate these findings to care, perhaps developing decision aids, interventions that may help with diagnosis and evaluation,” as is work on understanding the link between PD and symptoms such as hearing loss and epilepsy, he said.
Primary care offers opportunity to identify risk factors
The current study represents an important step in early recognition of PD, with implications for helping patients access treatments promptly and improve their quality of life, Bhavana Patel, DO, Shannon Chiu, MD, and Melissa J. Armstrong, MD, of the University of Florida, Gainesville, wrote in an accompanying editorial.
“The primary care setting is commonly where symptoms heralding the onset of PD are first discussed. However, little is known regarding the prediagnostic manifestations of PD that are seen in primary care clinics, particularly in underserved populations,” they wrote.
The study included many risk factors and prodromal markers associated with research criteria for prodromal PD, but did not include several risk and prodromal markers in the Movement Disorders Society research criteria, “such as symptoms suggestive of REM sleep behavior disorder, excessive daytime sleepiness (which overlaps with, but is distinct from, fatigue), urinary dysfunction, pesticide and solvent exposure, caffeine use, level of physical activity, and family history,” they said.
Even in individuals with diagnosed PD, certain symptoms, particularly nonmotor symptoms, are commonly underreported,” and primary care clinicians may not recognize these symptoms as PD risk factors, the authors noted.
However, “in addition to contributing to possible models of modifiable risk factors for PD, study results may also further inform algorithms designed to predict PD diagnoses in primary care,” they said. The study also highlights the need for more multivariable models to better identify PD risk factors and strategies for early identification of PD in primary care.
Several study coauthors received funding related to the study from Barts Charity, Health Data Research UK, the Department of Health and Social Care (England) and the devolved administrations, and leading medical research charities, as well as the National Institute for Health Research UCLH Biomedical Research Centre. Lead author Dr. Simonet and Dr. Hung had no financial conflicts to disclose. Dr. Patel disclosed support from the National Institute on Aging, the Mangurian-Fixel-McKnight Collaboration for Pilot Studies in Lewy Body Dementia, and the American Brain Foundation and the Mary E. Groff Charitable Trust. Dr. Chiu reported receiving grants from Mangurian-Fixel-McKnight Collaboration for Pilot Studies in Lewy Body Dementia and the Smallwood Foundation. Dr. Armstrong disclosed funding from the National Institute on Aging, the Florida Department of Health, the Lewy Body Dementia Association, the Alzheimer’s Therapeutic Research Institute/Alzheimer’s Clinical Trial Consortium, the Alzheimer’s Disease Cooperative Study as Data Safety Monitoring Board the Parkinson’s Foundation, and the American Academy of Neurology.
Tremors and memory symptoms were identified among individuals in a primary care setting as early as 10 years before a Parkinson’s disease diagnosis in a new study.
Most research on the causes and early signs of Parkinson’s disease (PD) have involved patients of Northern European ancestry, Cristina Simonet, MD, of Queen Mary University of London, and colleagues wrote in their paper, published in JAMA Neurology.
Additionally, data on how PD might manifest in different ethnic groups are limited, they said.
In their nested case-control, the researchers examined data from electronic health records of an ethnically diverse population of 1,016,277 adults seen in primary care practices between 1990 and Feb. 6, 2018. They compared individuals with PD with those without PD or other neurologic conditions.
The researchers identified 10 age and sex-matched controls for each PD case, and also conducted an unmatched analysis after adjusting for age and sex. The final study population included 1,055 patients with PD and 1,009,523 controls. The population of PD cases was 15.7% Black, 19.7% South Asian, 50.9% White, and 8.3% other; the population of controls was 13.3% Black, 21.5% South Asian, 43.7% White, and 11.3% other.
“We observed a constellation of symptoms noted by general practitioners up to a decade before diagnosis of PD,” the researchers said. Symptoms were identified across three time intervals (less than 2 years, 2-5 years, and 5-10 years before diagnosis) to better evaluate exposure outcome associations.
In the matched analysis of midlife risk factors, epilepsy showed the strongest association with PD diagnosis across all time periods, and type 2 diabetes or hypertension 5-10 years before diagnosis was associated with later PD.
Prediagnostic signs of PD included both motor and nonmotor manifestations.
The matched analysis revealed a significant increased association between tremor and memory symptoms less than 2 years before diagnosis (adjusted odds ratios of 151.24 and 8.73, respectively) as well as up to 10 years before diagnosis for tremors and up to 5 years for memory symptoms (aOR, 11.4 and 3.09, respectively) in PD patients, compared with controls.
Other strong associations between PD and early nonmotor features in cases, compared with controls, included hypotension (aOR, 6.81), constipation (aOR, 3.29), and depression (aOR, 4.61).
In addition, the researchers found associations for epilepsy that had not been identified in previous studies, and these associations persisted in a replication analysis.
The study findings were limited by several factors, mainly the use of routine primary care data with underascertained factors of interest, and potential mislabeling of PD, the researchers noted. Other limitations included the lack of data on prescription medication for PD, and the recording of memory problems in primary care without supportive testing to confirm cognitive impairment.
The results support a range of comorbidities and symptoms that may present in primary care, and clinicians should consider PD as a possible cause, the researchers wrote.
Make early referral a priority
The study is important because of the lack of diversity in Parkinson’s disease research, lead author Dr. Simonet said in an interview.
“Over the last decade, the global population suffering from Parkinson’s disease has more than doubled,” she said. Causes may include the increasing numbers of older people with longer life expectancy. “However, it seems there are other factors, including environmental, genetic, and lifestyle, that might play a role in increasing the prevalence of Parkinson’s disease.”
“More representative studies, including minority ethnic groups and those living in areas of high social and economic deprivation, are needed,” Dr. Simonet emphasized.
She said that there is little research on the association with epilepsy and hearing loss in early PD, and “for that reason, our results should encourage further studies to confirm a possible link between these manifestations and Parkinson’s disease.”
Early detection may drive better diagnoses
The current study is important for understanding the prediagnostic features and risk factors that may allow for earlier detection of Parkinson’s disease, William Hung, MD, a geriatrics and palliative care specialist of the Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Prior to this study, there was limited understanding of these features.
“One surprise [in the findings] was that ethnicity and socioeconomic deprivation do not appear to be associated with the risk of PD, in contrast to other illnesses such as dementia,” said Dr. Hung. “The array of prediagnostic features associated with PD is not surprising, but nonetheless important for clinicians to know to consider whether PD could be the underlying cause.”
The take-home message for primary care is that “there are features, such as hearing loss, history of epilepsy, autonomic symptoms, motor symptoms, among others, for which clinicians should consider PD as part of the differential diagnosis as underlying cause and consider referral to specialists for diagnostic clarification,” said Dr. Hung.
“Additional research is needed to translate these findings to care, perhaps developing decision aids, interventions that may help with diagnosis and evaluation,” as is work on understanding the link between PD and symptoms such as hearing loss and epilepsy, he said.
Primary care offers opportunity to identify risk factors
The current study represents an important step in early recognition of PD, with implications for helping patients access treatments promptly and improve their quality of life, Bhavana Patel, DO, Shannon Chiu, MD, and Melissa J. Armstrong, MD, of the University of Florida, Gainesville, wrote in an accompanying editorial.
“The primary care setting is commonly where symptoms heralding the onset of PD are first discussed. However, little is known regarding the prediagnostic manifestations of PD that are seen in primary care clinics, particularly in underserved populations,” they wrote.
The study included many risk factors and prodromal markers associated with research criteria for prodromal PD, but did not include several risk and prodromal markers in the Movement Disorders Society research criteria, “such as symptoms suggestive of REM sleep behavior disorder, excessive daytime sleepiness (which overlaps with, but is distinct from, fatigue), urinary dysfunction, pesticide and solvent exposure, caffeine use, level of physical activity, and family history,” they said.
Even in individuals with diagnosed PD, certain symptoms, particularly nonmotor symptoms, are commonly underreported,” and primary care clinicians may not recognize these symptoms as PD risk factors, the authors noted.
However, “in addition to contributing to possible models of modifiable risk factors for PD, study results may also further inform algorithms designed to predict PD diagnoses in primary care,” they said. The study also highlights the need for more multivariable models to better identify PD risk factors and strategies for early identification of PD in primary care.
Several study coauthors received funding related to the study from Barts Charity, Health Data Research UK, the Department of Health and Social Care (England) and the devolved administrations, and leading medical research charities, as well as the National Institute for Health Research UCLH Biomedical Research Centre. Lead author Dr. Simonet and Dr. Hung had no financial conflicts to disclose. Dr. Patel disclosed support from the National Institute on Aging, the Mangurian-Fixel-McKnight Collaboration for Pilot Studies in Lewy Body Dementia, and the American Brain Foundation and the Mary E. Groff Charitable Trust. Dr. Chiu reported receiving grants from Mangurian-Fixel-McKnight Collaboration for Pilot Studies in Lewy Body Dementia and the Smallwood Foundation. Dr. Armstrong disclosed funding from the National Institute on Aging, the Florida Department of Health, the Lewy Body Dementia Association, the Alzheimer’s Therapeutic Research Institute/Alzheimer’s Clinical Trial Consortium, the Alzheimer’s Disease Cooperative Study as Data Safety Monitoring Board the Parkinson’s Foundation, and the American Academy of Neurology.
Tremors and memory symptoms were identified among individuals in a primary care setting as early as 10 years before a Parkinson’s disease diagnosis in a new study.
Most research on the causes and early signs of Parkinson’s disease (PD) have involved patients of Northern European ancestry, Cristina Simonet, MD, of Queen Mary University of London, and colleagues wrote in their paper, published in JAMA Neurology.
Additionally, data on how PD might manifest in different ethnic groups are limited, they said.
In their nested case-control, the researchers examined data from electronic health records of an ethnically diverse population of 1,016,277 adults seen in primary care practices between 1990 and Feb. 6, 2018. They compared individuals with PD with those without PD or other neurologic conditions.
The researchers identified 10 age and sex-matched controls for each PD case, and also conducted an unmatched analysis after adjusting for age and sex. The final study population included 1,055 patients with PD and 1,009,523 controls. The population of PD cases was 15.7% Black, 19.7% South Asian, 50.9% White, and 8.3% other; the population of controls was 13.3% Black, 21.5% South Asian, 43.7% White, and 11.3% other.
“We observed a constellation of symptoms noted by general practitioners up to a decade before diagnosis of PD,” the researchers said. Symptoms were identified across three time intervals (less than 2 years, 2-5 years, and 5-10 years before diagnosis) to better evaluate exposure outcome associations.
In the matched analysis of midlife risk factors, epilepsy showed the strongest association with PD diagnosis across all time periods, and type 2 diabetes or hypertension 5-10 years before diagnosis was associated with later PD.
Prediagnostic signs of PD included both motor and nonmotor manifestations.
The matched analysis revealed a significant increased association between tremor and memory symptoms less than 2 years before diagnosis (adjusted odds ratios of 151.24 and 8.73, respectively) as well as up to 10 years before diagnosis for tremors and up to 5 years for memory symptoms (aOR, 11.4 and 3.09, respectively) in PD patients, compared with controls.
Other strong associations between PD and early nonmotor features in cases, compared with controls, included hypotension (aOR, 6.81), constipation (aOR, 3.29), and depression (aOR, 4.61).
In addition, the researchers found associations for epilepsy that had not been identified in previous studies, and these associations persisted in a replication analysis.
The study findings were limited by several factors, mainly the use of routine primary care data with underascertained factors of interest, and potential mislabeling of PD, the researchers noted. Other limitations included the lack of data on prescription medication for PD, and the recording of memory problems in primary care without supportive testing to confirm cognitive impairment.
The results support a range of comorbidities and symptoms that may present in primary care, and clinicians should consider PD as a possible cause, the researchers wrote.
Make early referral a priority
The study is important because of the lack of diversity in Parkinson’s disease research, lead author Dr. Simonet said in an interview.
“Over the last decade, the global population suffering from Parkinson’s disease has more than doubled,” she said. Causes may include the increasing numbers of older people with longer life expectancy. “However, it seems there are other factors, including environmental, genetic, and lifestyle, that might play a role in increasing the prevalence of Parkinson’s disease.”
“More representative studies, including minority ethnic groups and those living in areas of high social and economic deprivation, are needed,” Dr. Simonet emphasized.
She said that there is little research on the association with epilepsy and hearing loss in early PD, and “for that reason, our results should encourage further studies to confirm a possible link between these manifestations and Parkinson’s disease.”
Early detection may drive better diagnoses
The current study is important for understanding the prediagnostic features and risk factors that may allow for earlier detection of Parkinson’s disease, William Hung, MD, a geriatrics and palliative care specialist of the Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Prior to this study, there was limited understanding of these features.
“One surprise [in the findings] was that ethnicity and socioeconomic deprivation do not appear to be associated with the risk of PD, in contrast to other illnesses such as dementia,” said Dr. Hung. “The array of prediagnostic features associated with PD is not surprising, but nonetheless important for clinicians to know to consider whether PD could be the underlying cause.”
The take-home message for primary care is that “there are features, such as hearing loss, history of epilepsy, autonomic symptoms, motor symptoms, among others, for which clinicians should consider PD as part of the differential diagnosis as underlying cause and consider referral to specialists for diagnostic clarification,” said Dr. Hung.
“Additional research is needed to translate these findings to care, perhaps developing decision aids, interventions that may help with diagnosis and evaluation,” as is work on understanding the link between PD and symptoms such as hearing loss and epilepsy, he said.
Primary care offers opportunity to identify risk factors
The current study represents an important step in early recognition of PD, with implications for helping patients access treatments promptly and improve their quality of life, Bhavana Patel, DO, Shannon Chiu, MD, and Melissa J. Armstrong, MD, of the University of Florida, Gainesville, wrote in an accompanying editorial.
“The primary care setting is commonly where symptoms heralding the onset of PD are first discussed. However, little is known regarding the prediagnostic manifestations of PD that are seen in primary care clinics, particularly in underserved populations,” they wrote.
The study included many risk factors and prodromal markers associated with research criteria for prodromal PD, but did not include several risk and prodromal markers in the Movement Disorders Society research criteria, “such as symptoms suggestive of REM sleep behavior disorder, excessive daytime sleepiness (which overlaps with, but is distinct from, fatigue), urinary dysfunction, pesticide and solvent exposure, caffeine use, level of physical activity, and family history,” they said.
Even in individuals with diagnosed PD, certain symptoms, particularly nonmotor symptoms, are commonly underreported,” and primary care clinicians may not recognize these symptoms as PD risk factors, the authors noted.
However, “in addition to contributing to possible models of modifiable risk factors for PD, study results may also further inform algorithms designed to predict PD diagnoses in primary care,” they said. The study also highlights the need for more multivariable models to better identify PD risk factors and strategies for early identification of PD in primary care.
Several study coauthors received funding related to the study from Barts Charity, Health Data Research UK, the Department of Health and Social Care (England) and the devolved administrations, and leading medical research charities, as well as the National Institute for Health Research UCLH Biomedical Research Centre. Lead author Dr. Simonet and Dr. Hung had no financial conflicts to disclose. Dr. Patel disclosed support from the National Institute on Aging, the Mangurian-Fixel-McKnight Collaboration for Pilot Studies in Lewy Body Dementia, and the American Brain Foundation and the Mary E. Groff Charitable Trust. Dr. Chiu reported receiving grants from Mangurian-Fixel-McKnight Collaboration for Pilot Studies in Lewy Body Dementia and the Smallwood Foundation. Dr. Armstrong disclosed funding from the National Institute on Aging, the Florida Department of Health, the Lewy Body Dementia Association, the Alzheimer’s Therapeutic Research Institute/Alzheimer’s Clinical Trial Consortium, the Alzheimer’s Disease Cooperative Study as Data Safety Monitoring Board the Parkinson’s Foundation, and the American Academy of Neurology.
FROM JAMA NEUROLOGY
Past spontaneous abortion raises risk for gestational diabetes
Pregnant women with a history of spontaneous abortion had a significantly increased risk of gestational diabetes in subsequent pregnancies, based on data from more than 100,000 women.
Gestational diabetes is associated not only with adverse perinatal outcomes, but also with an increased risk of long-term cardiovascular and metabolic health issues in mothers and children, wrote Yan Zhao, PhD, of Tongji University, Shanghai, and colleagues.
Previous studies also have shown that spontaneous abortion (SAB) is associated with later maternal risk of cardiovascular disease and venous thromboembolism, the researchers said. The same mechanisms might contribute to the development of gestational diabetes, but the association between abortion history and gestational diabetes risk in subsequent pregnancies remains unclear, they added.
In a study published in JAMA Network Open, the researchers identified 102,259 pregnant women seen for routine prenatal care at a single hospital in Shanghai between January 2014 and December 2019. The mean age of the women was 29.8 years.
During the study period, 14,579 women experienced SAB (14.3%), 17,935 experienced induced abortion (17.5%), and 4,017 experienced both (11.9%).
In all, 12,153 cases of gestational diabetes were identified, for a prevalence of 11.9%. The relative risk of gestational diabetes was 1.25 for women who experienced SAB and 1.15 for those who experienced both SAB and induced abortion, and the association between SAB and gestational diabetes increased in a number-dependent manner, the researchers said. The increase in relative risk for gestational diabetes in pregnant women with one SAB, two SABs, and three or more SABs was 18%, 41%, and 43%, compared to pregnant women with no SAB history.
However, no association appeared between a history of induced abortion and gestational diabetes, the researchers said. “To date, no study has reported the association of prior induced abortion with gestational diabetes,” they wrote.
The study findings were limited by several factors including the reliance on self-reports for history of SAB and therefore possible underreporting, the researchers noted. Other limitations included the lack of data on the timing of SABs; therefore, the time between SAB and gestational diabetes diagnosis could not be included in the analysis, they said. Unknown variables and the inclusion only of women from a single city in China might limit the generalizability of the results, they added.
More research is needed to understand the biological mechanisms behind the association between SAB and gestational diabetes, an association that has potential public health implications, they noted. However, the results suggest that “pregnant women with a history of SAB, especially those with a history of recurrent SAB, should attend more antenatal visits to monitor their blood glucose and implement early prevention and intervention,” such as healthful eating and regular exercise, they wrote.
Findings confirm, not surprise
The diagnosis of gestational diabetes in the current study “was made with a slightly different test than we typically use in the United States – a 1-hour nonfasting glucola followed by a confirmatory 3-hour fasting glucola,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. The current study of both SAB and gestational diabetes is important because both conditions are very common and have been the focus of increased attention in the popular media and in scientific study, she said.
Dr. Prager said she was not surprised by the findings of a link between a history of gestational diabetes and a history of SAB, “but the association is likely that people at risk for gestational diabetes or who have undiagnosed diabetes/glucose intolerance are more likely to experience SAB,” she noted. “I would be surprised if the direction of the association is that SAB puts people at risk for gestational diabetes; more likely undiagnosed diabetes is a risk factor for SAB,” she added. “Perhaps we should be screening for glucose intolerance and other metabolic disorders more frequently in people who have especially recurrent SAB, as the more miscarriages someone had, the more likely they were in this study to be diagnosed with gestational diabetes;” or perhaps those with a history of SAB/recurrent SAB should be screened closer to 24 weeks’ than 28 weeks’ gestation to enable earlier intervention in those more likely to have gestational diabetes, Dr. Prager said.
The study was supported by the Key Program of the National Natural Science Foundation of China, the National Natural Science Foundation of China, the National Key Research and Development Program of China, the Shanghai Municipal Medical and Health Discipline Construction Projects, and the Shanghai Rising-Star Program. The researchers and Dr. Prager had no financial conflicts to disclose. Dr. Prager serves on the editorial advisory board of Ob.Gyn. News.
Pregnant women with a history of spontaneous abortion had a significantly increased risk of gestational diabetes in subsequent pregnancies, based on data from more than 100,000 women.
Gestational diabetes is associated not only with adverse perinatal outcomes, but also with an increased risk of long-term cardiovascular and metabolic health issues in mothers and children, wrote Yan Zhao, PhD, of Tongji University, Shanghai, and colleagues.
Previous studies also have shown that spontaneous abortion (SAB) is associated with later maternal risk of cardiovascular disease and venous thromboembolism, the researchers said. The same mechanisms might contribute to the development of gestational diabetes, but the association between abortion history and gestational diabetes risk in subsequent pregnancies remains unclear, they added.
In a study published in JAMA Network Open, the researchers identified 102,259 pregnant women seen for routine prenatal care at a single hospital in Shanghai between January 2014 and December 2019. The mean age of the women was 29.8 years.
During the study period, 14,579 women experienced SAB (14.3%), 17,935 experienced induced abortion (17.5%), and 4,017 experienced both (11.9%).
In all, 12,153 cases of gestational diabetes were identified, for a prevalence of 11.9%. The relative risk of gestational diabetes was 1.25 for women who experienced SAB and 1.15 for those who experienced both SAB and induced abortion, and the association between SAB and gestational diabetes increased in a number-dependent manner, the researchers said. The increase in relative risk for gestational diabetes in pregnant women with one SAB, two SABs, and three or more SABs was 18%, 41%, and 43%, compared to pregnant women with no SAB history.
However, no association appeared between a history of induced abortion and gestational diabetes, the researchers said. “To date, no study has reported the association of prior induced abortion with gestational diabetes,” they wrote.
The study findings were limited by several factors including the reliance on self-reports for history of SAB and therefore possible underreporting, the researchers noted. Other limitations included the lack of data on the timing of SABs; therefore, the time between SAB and gestational diabetes diagnosis could not be included in the analysis, they said. Unknown variables and the inclusion only of women from a single city in China might limit the generalizability of the results, they added.
More research is needed to understand the biological mechanisms behind the association between SAB and gestational diabetes, an association that has potential public health implications, they noted. However, the results suggest that “pregnant women with a history of SAB, especially those with a history of recurrent SAB, should attend more antenatal visits to monitor their blood glucose and implement early prevention and intervention,” such as healthful eating and regular exercise, they wrote.
Findings confirm, not surprise
The diagnosis of gestational diabetes in the current study “was made with a slightly different test than we typically use in the United States – a 1-hour nonfasting glucola followed by a confirmatory 3-hour fasting glucola,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. The current study of both SAB and gestational diabetes is important because both conditions are very common and have been the focus of increased attention in the popular media and in scientific study, she said.
Dr. Prager said she was not surprised by the findings of a link between a history of gestational diabetes and a history of SAB, “but the association is likely that people at risk for gestational diabetes or who have undiagnosed diabetes/glucose intolerance are more likely to experience SAB,” she noted. “I would be surprised if the direction of the association is that SAB puts people at risk for gestational diabetes; more likely undiagnosed diabetes is a risk factor for SAB,” she added. “Perhaps we should be screening for glucose intolerance and other metabolic disorders more frequently in people who have especially recurrent SAB, as the more miscarriages someone had, the more likely they were in this study to be diagnosed with gestational diabetes;” or perhaps those with a history of SAB/recurrent SAB should be screened closer to 24 weeks’ than 28 weeks’ gestation to enable earlier intervention in those more likely to have gestational diabetes, Dr. Prager said.
The study was supported by the Key Program of the National Natural Science Foundation of China, the National Natural Science Foundation of China, the National Key Research and Development Program of China, the Shanghai Municipal Medical and Health Discipline Construction Projects, and the Shanghai Rising-Star Program. The researchers and Dr. Prager had no financial conflicts to disclose. Dr. Prager serves on the editorial advisory board of Ob.Gyn. News.
Pregnant women with a history of spontaneous abortion had a significantly increased risk of gestational diabetes in subsequent pregnancies, based on data from more than 100,000 women.
Gestational diabetes is associated not only with adverse perinatal outcomes, but also with an increased risk of long-term cardiovascular and metabolic health issues in mothers and children, wrote Yan Zhao, PhD, of Tongji University, Shanghai, and colleagues.
Previous studies also have shown that spontaneous abortion (SAB) is associated with later maternal risk of cardiovascular disease and venous thromboembolism, the researchers said. The same mechanisms might contribute to the development of gestational diabetes, but the association between abortion history and gestational diabetes risk in subsequent pregnancies remains unclear, they added.
In a study published in JAMA Network Open, the researchers identified 102,259 pregnant women seen for routine prenatal care at a single hospital in Shanghai between January 2014 and December 2019. The mean age of the women was 29.8 years.
During the study period, 14,579 women experienced SAB (14.3%), 17,935 experienced induced abortion (17.5%), and 4,017 experienced both (11.9%).
In all, 12,153 cases of gestational diabetes were identified, for a prevalence of 11.9%. The relative risk of gestational diabetes was 1.25 for women who experienced SAB and 1.15 for those who experienced both SAB and induced abortion, and the association between SAB and gestational diabetes increased in a number-dependent manner, the researchers said. The increase in relative risk for gestational diabetes in pregnant women with one SAB, two SABs, and three or more SABs was 18%, 41%, and 43%, compared to pregnant women with no SAB history.
However, no association appeared between a history of induced abortion and gestational diabetes, the researchers said. “To date, no study has reported the association of prior induced abortion with gestational diabetes,” they wrote.
The study findings were limited by several factors including the reliance on self-reports for history of SAB and therefore possible underreporting, the researchers noted. Other limitations included the lack of data on the timing of SABs; therefore, the time between SAB and gestational diabetes diagnosis could not be included in the analysis, they said. Unknown variables and the inclusion only of women from a single city in China might limit the generalizability of the results, they added.
More research is needed to understand the biological mechanisms behind the association between SAB and gestational diabetes, an association that has potential public health implications, they noted. However, the results suggest that “pregnant women with a history of SAB, especially those with a history of recurrent SAB, should attend more antenatal visits to monitor their blood glucose and implement early prevention and intervention,” such as healthful eating and regular exercise, they wrote.
Findings confirm, not surprise
The diagnosis of gestational diabetes in the current study “was made with a slightly different test than we typically use in the United States – a 1-hour nonfasting glucola followed by a confirmatory 3-hour fasting glucola,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. The current study of both SAB and gestational diabetes is important because both conditions are very common and have been the focus of increased attention in the popular media and in scientific study, she said.
Dr. Prager said she was not surprised by the findings of a link between a history of gestational diabetes and a history of SAB, “but the association is likely that people at risk for gestational diabetes or who have undiagnosed diabetes/glucose intolerance are more likely to experience SAB,” she noted. “I would be surprised if the direction of the association is that SAB puts people at risk for gestational diabetes; more likely undiagnosed diabetes is a risk factor for SAB,” she added. “Perhaps we should be screening for glucose intolerance and other metabolic disorders more frequently in people who have especially recurrent SAB, as the more miscarriages someone had, the more likely they were in this study to be diagnosed with gestational diabetes;” or perhaps those with a history of SAB/recurrent SAB should be screened closer to 24 weeks’ than 28 weeks’ gestation to enable earlier intervention in those more likely to have gestational diabetes, Dr. Prager said.
The study was supported by the Key Program of the National Natural Science Foundation of China, the National Natural Science Foundation of China, the National Key Research and Development Program of China, the Shanghai Municipal Medical and Health Discipline Construction Projects, and the Shanghai Rising-Star Program. The researchers and Dr. Prager had no financial conflicts to disclose. Dr. Prager serves on the editorial advisory board of Ob.Gyn. News.
FROM JAMA NETWORK OPEN