CHEST Physician

The risk of being hospitalized because of COVID-19 was reduced by 84% among people who used Paxlovid, reports a new study.

This medicine has been approved for use in the United States for people over 12 years old who are at risk of having a severe COVID-19 infection. 

The study was published in the Journal of Antimicrobial Chemotherapy.

Study authors examined the health records of almost 45,000 outpatients who tested positive for COVID-19 from January to August 2022. This sample period was when the Omicron strain was dominant.

The average patient age was 47. Sixty-two percent were White, 24% were Black, 6% were Hispanic, and 8% had an unknown ethnicity. A slight majority, 51%, had received two or more vaccine doses before the study period.

From the study group, 201 people were hospitalized within 28 days of their positive COVID test.

Almost 5,000 people in the study group received Paxlovid. The use of Paxlovid was the best indicator of avoiding hospitalization, with three of those people being hospitalized.

“Patients who were treated with Paxlovid were twice as likely to have received at least two doses of COVID-19 vaccine,” the University of Minnesota’s CIDRAP reported. “They were also more likely to be 70 years or older.”

People taking Paxlovid were more likely to be White and to live in middle- or upper-income areas.

“COVID-19 hospitalization risk was reduced by 84% among [Paxlovid] recipients in a large, diverse healthcare system during the Omicron wave,” the study’s authors wrote. “These results suggest that [Paxlovid] remained highly effective in a setting substantially different than the original clinical trials.”
 

A version of this article appeared on WebMD.com.

The risk of being hospitalized because of COVID-19 was reduced by 84% among people who used Paxlovid, reports a new study.

This medicine has been approved for use in the United States for people over 12 years old who are at risk of having a severe COVID-19 infection. 

The study was published in the Journal of Antimicrobial Chemotherapy.

Study authors examined the health records of almost 45,000 outpatients who tested positive for COVID-19 from January to August 2022. This sample period was when the Omicron strain was dominant.

The average patient age was 47. Sixty-two percent were White, 24% were Black, 6% were Hispanic, and 8% had an unknown ethnicity. A slight majority, 51%, had received two or more vaccine doses before the study period.

From the study group, 201 people were hospitalized within 28 days of their positive COVID test.

Almost 5,000 people in the study group received Paxlovid. The use of Paxlovid was the best indicator of avoiding hospitalization, with three of those people being hospitalized.

“Patients who were treated with Paxlovid were twice as likely to have received at least two doses of COVID-19 vaccine,” the University of Minnesota’s CIDRAP reported. “They were also more likely to be 70 years or older.”

People taking Paxlovid were more likely to be White and to live in middle- or upper-income areas.

“COVID-19 hospitalization risk was reduced by 84% among [Paxlovid] recipients in a large, diverse healthcare system during the Omicron wave,” the study’s authors wrote. “These results suggest that [Paxlovid] remained highly effective in a setting substantially different than the original clinical trials.”
 

A version of this article appeared on WebMD.com.

The risk of being hospitalized because of COVID-19 was reduced by 84% among people who used Paxlovid, reports a new study.

This medicine has been approved for use in the United States for people over 12 years old who are at risk of having a severe COVID-19 infection. 

The study was published in the Journal of Antimicrobial Chemotherapy.

Study authors examined the health records of almost 45,000 outpatients who tested positive for COVID-19 from January to August 2022. This sample period was when the Omicron strain was dominant.

The average patient age was 47. Sixty-two percent were White, 24% were Black, 6% were Hispanic, and 8% had an unknown ethnicity. A slight majority, 51%, had received two or more vaccine doses before the study period.

From the study group, 201 people were hospitalized within 28 days of their positive COVID test.

Almost 5,000 people in the study group received Paxlovid. The use of Paxlovid was the best indicator of avoiding hospitalization, with three of those people being hospitalized.

“Patients who were treated with Paxlovid were twice as likely to have received at least two doses of COVID-19 vaccine,” the University of Minnesota’s CIDRAP reported. “They were also more likely to be 70 years or older.”

People taking Paxlovid were more likely to be White and to live in middle- or upper-income areas.

“COVID-19 hospitalization risk was reduced by 84% among [Paxlovid] recipients in a large, diverse healthcare system during the Omicron wave,” the study’s authors wrote. “These results suggest that [Paxlovid] remained highly effective in a setting substantially different than the original clinical trials.”
 

A version of this article appeared on WebMD.com.

TOPLINE:

Intermittent hypoxemia prompted higher postprandial plasma triglyceride levels in men than in women compared with normoxia.

METHODOLOGY:

• Potential gender differences in the impact of intermittent hypoxemia on triglycerides have not been well studied, despite the increased risk for metabolic comorbidities in obstructive sleep apnea (OSA).
• The researchers recruited 24 healthy young adults with a mean age of 23.3 years for the 12 men and 21.3 years for the 12 women.
• Participants consumed a high-fat meal followed by 6 hours of exposure to intermittent hypoxemia or ambient air; the primary outcome was changes in postprandial plasma triglyceride levels.

TAKEAWAY:

• Intermittent hypoxemia was associated with significantly higher postprandial triglycerides in men but not in women.
• Women had lower levels of total triglycerides as well as denser triglyceride-rich lipoprotein triglycerides (TRL-TG) and buoyant TRL-TG in both normoxia and hypoxemia conditions compared with men.
• Glucose levels were significantly higher in men and significantly lower in women during intermittent hypoxemia compared with normoxia (P < .001 for both sexes).

IN PRACTICE:

“Although there is a need for larger confirmatory studies in individuals living with obstructive sleep apnea, this study demonstrates that intermittent hypoxemia alters triglyceride metabolism differently between men and women,” the researchers wrote.

SOURCE:

The lead author of the study was Nicholas Goulet, MD, of the University of Ottawa, Ottawa, Ontario, Canada. The study was published online in The Journal of Physiology on January 29, 2024.

LIMITATIONS:

Limitations of the study included the experimental design with simulated OSA, the small and homogeneous study population, the use of a specific profile for intermittent hypoxemia, and the use of a specific high-fat meal.

DISCLOSURES:

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Association Médicale Universitaire de l’Hôpital Montfort. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Intermittent hypoxemia prompted higher postprandial plasma triglyceride levels in men than in women compared with normoxia.

METHODOLOGY:

• Potential gender differences in the impact of intermittent hypoxemia on triglycerides have not been well studied, despite the increased risk for metabolic comorbidities in obstructive sleep apnea (OSA).
• The researchers recruited 24 healthy young adults with a mean age of 23.3 years for the 12 men and 21.3 years for the 12 women.
• Participants consumed a high-fat meal followed by 6 hours of exposure to intermittent hypoxemia or ambient air; the primary outcome was changes in postprandial plasma triglyceride levels.

TAKEAWAY:

• Intermittent hypoxemia was associated with significantly higher postprandial triglycerides in men but not in women.
• Women had lower levels of total triglycerides as well as denser triglyceride-rich lipoprotein triglycerides (TRL-TG) and buoyant TRL-TG in both normoxia and hypoxemia conditions compared with men.
• Glucose levels were significantly higher in men and significantly lower in women during intermittent hypoxemia compared with normoxia (P < .001 for both sexes).

IN PRACTICE:

“Although there is a need for larger confirmatory studies in individuals living with obstructive sleep apnea, this study demonstrates that intermittent hypoxemia alters triglyceride metabolism differently between men and women,” the researchers wrote.

SOURCE:

The lead author of the study was Nicholas Goulet, MD, of the University of Ottawa, Ottawa, Ontario, Canada. The study was published online in The Journal of Physiology on January 29, 2024.

LIMITATIONS:

Limitations of the study included the experimental design with simulated OSA, the small and homogeneous study population, the use of a specific profile for intermittent hypoxemia, and the use of a specific high-fat meal.

DISCLOSURES:

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Association Médicale Universitaire de l’Hôpital Montfort. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Intermittent hypoxemia prompted higher postprandial plasma triglyceride levels in men than in women compared with normoxia.

METHODOLOGY:

• Potential gender differences in the impact of intermittent hypoxemia on triglycerides have not been well studied, despite the increased risk for metabolic comorbidities in obstructive sleep apnea (OSA).
• The researchers recruited 24 healthy young adults with a mean age of 23.3 years for the 12 men and 21.3 years for the 12 women.
• Participants consumed a high-fat meal followed by 6 hours of exposure to intermittent hypoxemia or ambient air; the primary outcome was changes in postprandial plasma triglyceride levels.

TAKEAWAY:

• Intermittent hypoxemia was associated with significantly higher postprandial triglycerides in men but not in women.
• Women had lower levels of total triglycerides as well as denser triglyceride-rich lipoprotein triglycerides (TRL-TG) and buoyant TRL-TG in both normoxia and hypoxemia conditions compared with men.
• Glucose levels were significantly higher in men and significantly lower in women during intermittent hypoxemia compared with normoxia (P < .001 for both sexes).

IN PRACTICE:

“Although there is a need for larger confirmatory studies in individuals living with obstructive sleep apnea, this study demonstrates that intermittent hypoxemia alters triglyceride metabolism differently between men and women,” the researchers wrote.

SOURCE:

The lead author of the study was Nicholas Goulet, MD, of the University of Ottawa, Ottawa, Ontario, Canada. The study was published online in The Journal of Physiology on January 29, 2024.

LIMITATIONS:

Limitations of the study included the experimental design with simulated OSA, the small and homogeneous study population, the use of a specific profile for intermittent hypoxemia, and the use of a specific high-fat meal.

DISCLOSURES:

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Association Médicale Universitaire de l’Hôpital Montfort. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Radiation exposure to the pulmonary veins during radiotherapy (RT) for non–small cell lung cancer (NSCLC) raises the risk for atrial fibrillation (AF), according to new findings.

METHODOLOGY:

• Arrhythmia — with AF being the most common type — affects roughly 11% of patients following lung cancer RT.
• Given RT’s recognized impact on cardiac tissues over time, researchers hypothesized that the dosage affecting pulmonary veins might contribute to the observed increased rates of AF after RT.
• To investigate, researchers looked back at 420 patients with NSCLC (52% women, median age 70) undergoing definitive RT (± chemo) with modern planning techniques at 55 Gy in 20 once-daily fractions over 4 weeks.
• Most patients underwent treatment planning using volumetric modulated arc therapy (50%) or static gantry intensity-modulated RT (20%). Chemotherapy was administered in a minority of cases (33%).
• Pulmonary veins were contoured on planning CT scans, and dose metrics were calculated. The association between pulmonary veins dose and incidence of new AF was evaluated, with AF verified by a cardiologist.

TAKEAWAY:

• Out of the entire cohort, 26 patients (6%) developed AF a median of 13 months after treatment. All cases of AF were grade 3 except for two grade 4 events.
• Radiation dose to the left and right pulmonary veins was significantly associated with incident AF. Dose volumes most strongly associated with AF were ≥ 55 Gy (V55) on the left and ≥ 10 Gy (V10) on the right.
• The risk for AF increased by 2% per percentage point increase in the left pulmonary veins V55 and 1% in the right pulmonary veins V10. The associations were statistically significant after accounting for cardiovascular factors and risk for death risk.
• The area under the curve for prediction of AF events was 0.64 (P = .02) for the left pulmonary veins V55 and 0.61 (P = .03) for the right pulmonary veins V10. The optimal thresholds for predicting AF were 2% and 54%, respectively.

IN PRACTICE:

“The implications of these data are that actively sparing these structures could reduce the incidence of [AF], and where this is not possible, patients identified as being at high risk of AF could undergo active screening during follow-up,” the researchers said, adding that further validation of these findings should take place before implementation.

SOURCE:

The study, with first author Gerard M. Walls, MB, MRCP, Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, Northern Ireland, was published online on January 4 in Radiotherapy and Oncology .

LIMITATIONS:

This was a single-center, retrospective study with a small number of AF events. The study may have underestimated the relationship between pulmonary vein irradiation and new AF events. The findings needed validation in larger datasets.

DISCLOSURES:

The study had no commercial funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Radiation exposure to the pulmonary veins during radiotherapy (RT) for non–small cell lung cancer (NSCLC) raises the risk for atrial fibrillation (AF), according to new findings.

METHODOLOGY:

• Arrhythmia — with AF being the most common type — affects roughly 11% of patients following lung cancer RT.
• Given RT’s recognized impact on cardiac tissues over time, researchers hypothesized that the dosage affecting pulmonary veins might contribute to the observed increased rates of AF after RT.
• To investigate, researchers looked back at 420 patients with NSCLC (52% women, median age 70) undergoing definitive RT (± chemo) with modern planning techniques at 55 Gy in 20 once-daily fractions over 4 weeks.
• Most patients underwent treatment planning using volumetric modulated arc therapy (50%) or static gantry intensity-modulated RT (20%). Chemotherapy was administered in a minority of cases (33%).
• Pulmonary veins were contoured on planning CT scans, and dose metrics were calculated. The association between pulmonary veins dose and incidence of new AF was evaluated, with AF verified by a cardiologist.

TAKEAWAY:

• Out of the entire cohort, 26 patients (6%) developed AF a median of 13 months after treatment. All cases of AF were grade 3 except for two grade 4 events.
• Radiation dose to the left and right pulmonary veins was significantly associated with incident AF. Dose volumes most strongly associated with AF were ≥ 55 Gy (V55) on the left and ≥ 10 Gy (V10) on the right.
• The risk for AF increased by 2% per percentage point increase in the left pulmonary veins V55 and 1% in the right pulmonary veins V10. The associations were statistically significant after accounting for cardiovascular factors and risk for death risk.
• The area under the curve for prediction of AF events was 0.64 (P = .02) for the left pulmonary veins V55 and 0.61 (P = .03) for the right pulmonary veins V10. The optimal thresholds for predicting AF were 2% and 54%, respectively.

IN PRACTICE:

“The implications of these data are that actively sparing these structures could reduce the incidence of [AF], and where this is not possible, patients identified as being at high risk of AF could undergo active screening during follow-up,” the researchers said, adding that further validation of these findings should take place before implementation.

SOURCE:

The study, with first author Gerard M. Walls, MB, MRCP, Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, Northern Ireland, was published online on January 4 in Radiotherapy and Oncology .

LIMITATIONS:

This was a single-center, retrospective study with a small number of AF events. The study may have underestimated the relationship between pulmonary vein irradiation and new AF events. The findings needed validation in larger datasets.

DISCLOSURES:

The study had no commercial funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Radiation exposure to the pulmonary veins during radiotherapy (RT) for non–small cell lung cancer (NSCLC) raises the risk for atrial fibrillation (AF), according to new findings.

METHODOLOGY:

• Arrhythmia — with AF being the most common type — affects roughly 11% of patients following lung cancer RT.
• Given RT’s recognized impact on cardiac tissues over time, researchers hypothesized that the dosage affecting pulmonary veins might contribute to the observed increased rates of AF after RT.
• To investigate, researchers looked back at 420 patients with NSCLC (52% women, median age 70) undergoing definitive RT (± chemo) with modern planning techniques at 55 Gy in 20 once-daily fractions over 4 weeks.
• Most patients underwent treatment planning using volumetric modulated arc therapy (50%) or static gantry intensity-modulated RT (20%). Chemotherapy was administered in a minority of cases (33%).
• Pulmonary veins were contoured on planning CT scans, and dose metrics were calculated. The association between pulmonary veins dose and incidence of new AF was evaluated, with AF verified by a cardiologist.

TAKEAWAY:

• Out of the entire cohort, 26 patients (6%) developed AF a median of 13 months after treatment. All cases of AF were grade 3 except for two grade 4 events.
• Radiation dose to the left and right pulmonary veins was significantly associated with incident AF. Dose volumes most strongly associated with AF were ≥ 55 Gy (V55) on the left and ≥ 10 Gy (V10) on the right.
• The risk for AF increased by 2% per percentage point increase in the left pulmonary veins V55 and 1% in the right pulmonary veins V10. The associations were statistically significant after accounting for cardiovascular factors and risk for death risk.
• The area under the curve for prediction of AF events was 0.64 (P = .02) for the left pulmonary veins V55 and 0.61 (P = .03) for the right pulmonary veins V10. The optimal thresholds for predicting AF were 2% and 54%, respectively.

IN PRACTICE:

“The implications of these data are that actively sparing these structures could reduce the incidence of [AF], and where this is not possible, patients identified as being at high risk of AF could undergo active screening during follow-up,” the researchers said, adding that further validation of these findings should take place before implementation.

SOURCE:

The study, with first author Gerard M. Walls, MB, MRCP, Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, Northern Ireland, was published online on January 4 in Radiotherapy and Oncology .

LIMITATIONS:

This was a single-center, retrospective study with a small number of AF events. The study may have underestimated the relationship between pulmonary vein irradiation and new AF events. The findings needed validation in larger datasets.

DISCLOSURES:

The study had no commercial funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

People vaccinated against COVID-19 were significantly less likely to have long COVID during the first few years of the pandemic, a new study from Michigan shows.

The findings were published in the journal Annals of Epidemiology. Researchers analyzed data for 4695 adults in Michigan, looking for people reporting COVID symptoms for more than 30 or more than 90 days after infection. They then looked at whether people had completed a full, initial vaccination series or not. Vaccinated people were 58% less likely than unvaccinated people to have symptoms lasting at least 30 days, and they were 43% less likely to have symptoms for 90 days or more.

The researchers did their study because previous estimates of how much vaccination protects against long COVID have varied widely due to different ways of doing the research, such as mixed definitions of long COVID or including a limited set of people in the unvaccinated comparison group. The researchers wrote that their study offers more certainty because the people who took part in it more widely represent the general population. All of the people in the study had lab test-confirmed infections of SARS-CoV-2 (the virus that causes COVID) between March 2020 and May 2022.

Among vaccinated and unvaccinated people combined, 32% of infected people said they had symptoms for at least 30 days, and nearly 18% said they had symptoms for 90 days or more, according to a summary of the study published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The researchers compared vaccinated and unvaccinated people multiple ways and consistently showed at least a 40% difference in long COVID.

In 2022, 6.9% of US adults self-reported that they had had long COVID, which researchers defined as symptoms for at least 3 months after testing positive or being diagnosed by a doctor, according to a report last week from the CDC. That report also showed that the states with the highest rates of long COVID in 2022 were Alabama, Montana, North Dakota, Oklahoma, Tennessee, West Virginia, and Wyoming. West Virginia had the highest rate of self-reported long COVID, at 10.6% of adults.

People with long COVID may have one or more of about 20 symptoms, including tiredness, fever, and problems that get worse after physical or mental effort. Other long-term signs are respiratory and heart symptoms, thinking problems, digestive issues, joint or muscle pain, rashes, or changes in menstrual cycles. The problems can be so severe that people may qualify for disability status.

About 8 in 10 US adults got the initial round of COVID vaccines, but just 22% of people reported receiving the latest version that became available in the fall of 2023.

The authors of the Michigan study wrote that “COVID-19 vaccination may be an important tool to reduce the burden of long COVID.”

A version of this article appeared on WebMD.com.

People vaccinated against COVID-19 were significantly less likely to have long COVID during the first few years of the pandemic, a new study from Michigan shows.

The findings were published in the journal Annals of Epidemiology. Researchers analyzed data for 4695 adults in Michigan, looking for people reporting COVID symptoms for more than 30 or more than 90 days after infection. They then looked at whether people had completed a full, initial vaccination series or not. Vaccinated people were 58% less likely than unvaccinated people to have symptoms lasting at least 30 days, and they were 43% less likely to have symptoms for 90 days or more.

The researchers did their study because previous estimates of how much vaccination protects against long COVID have varied widely due to different ways of doing the research, such as mixed definitions of long COVID or including a limited set of people in the unvaccinated comparison group. The researchers wrote that their study offers more certainty because the people who took part in it more widely represent the general population. All of the people in the study had lab test-confirmed infections of SARS-CoV-2 (the virus that causes COVID) between March 2020 and May 2022.

Among vaccinated and unvaccinated people combined, 32% of infected people said they had symptoms for at least 30 days, and nearly 18% said they had symptoms for 90 days or more, according to a summary of the study published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The researchers compared vaccinated and unvaccinated people multiple ways and consistently showed at least a 40% difference in long COVID.

In 2022, 6.9% of US adults self-reported that they had had long COVID, which researchers defined as symptoms for at least 3 months after testing positive or being diagnosed by a doctor, according to a report last week from the CDC. That report also showed that the states with the highest rates of long COVID in 2022 were Alabama, Montana, North Dakota, Oklahoma, Tennessee, West Virginia, and Wyoming. West Virginia had the highest rate of self-reported long COVID, at 10.6% of adults.

People with long COVID may have one or more of about 20 symptoms, including tiredness, fever, and problems that get worse after physical or mental effort. Other long-term signs are respiratory and heart symptoms, thinking problems, digestive issues, joint or muscle pain, rashes, or changes in menstrual cycles. The problems can be so severe that people may qualify for disability status.

About 8 in 10 US adults got the initial round of COVID vaccines, but just 22% of people reported receiving the latest version that became available in the fall of 2023.

The authors of the Michigan study wrote that “COVID-19 vaccination may be an important tool to reduce the burden of long COVID.”

A version of this article appeared on WebMD.com.

People vaccinated against COVID-19 were significantly less likely to have long COVID during the first few years of the pandemic, a new study from Michigan shows.

The findings were published in the journal Annals of Epidemiology. Researchers analyzed data for 4695 adults in Michigan, looking for people reporting COVID symptoms for more than 30 or more than 90 days after infection. They then looked at whether people had completed a full, initial vaccination series or not. Vaccinated people were 58% less likely than unvaccinated people to have symptoms lasting at least 30 days, and they were 43% less likely to have symptoms for 90 days or more.

The researchers did their study because previous estimates of how much vaccination protects against long COVID have varied widely due to different ways of doing the research, such as mixed definitions of long COVID or including a limited set of people in the unvaccinated comparison group. The researchers wrote that their study offers more certainty because the people who took part in it more widely represent the general population. All of the people in the study had lab test-confirmed infections of SARS-CoV-2 (the virus that causes COVID) between March 2020 and May 2022.

Among vaccinated and unvaccinated people combined, 32% of infected people said they had symptoms for at least 30 days, and nearly 18% said they had symptoms for 90 days or more, according to a summary of the study published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The researchers compared vaccinated and unvaccinated people multiple ways and consistently showed at least a 40% difference in long COVID.

In 2022, 6.9% of US adults self-reported that they had had long COVID, which researchers defined as symptoms for at least 3 months after testing positive or being diagnosed by a doctor, according to a report last week from the CDC. That report also showed that the states with the highest rates of long COVID in 2022 were Alabama, Montana, North Dakota, Oklahoma, Tennessee, West Virginia, and Wyoming. West Virginia had the highest rate of self-reported long COVID, at 10.6% of adults.

People with long COVID may have one or more of about 20 symptoms, including tiredness, fever, and problems that get worse after physical or mental effort. Other long-term signs are respiratory and heart symptoms, thinking problems, digestive issues, joint or muscle pain, rashes, or changes in menstrual cycles. The problems can be so severe that people may qualify for disability status.

About 8 in 10 US adults got the initial round of COVID vaccines, but just 22% of people reported receiving the latest version that became available in the fall of 2023.

The authors of the Michigan study wrote that “COVID-19 vaccination may be an important tool to reduce the burden of long COVID.”

A version of this article appeared on WebMD.com.

Communicating bad news to patients is one of the most stressful and challenging clinical tasks for any physician, regardless of his or her specialty. Delivering bad news to a patient or their close relative is demanding because the information provided during the dialogue can substantially alter the person’s perspective on life. This task is more frequent for physicians caring for oncology patients and can also affect the physician’s emotional state.

The manner in which bad news is communicated plays a significant role in the psychological burden on the patient, and various communication techniques and guidelines have been developed to enable physicians to perform this difficult task effectively.

Revealing bad news in person whenever possible, to address the emotional responses of patients or relatives, is part of the prevailing expert recommendations. However, it has been acknowledged that in certain situations, communicating bad news over the phone is more feasible.

Since the beginning of the COVID-19 pandemic, the disclosure of bad news over the phone has become a necessary substitute for in-person visits and an integral part of clinical practice worldwide. It remains to be clarified what the real psychological impact on patients and their closest relatives is when delivering bad news over the phone compared with delivering it in person.

Right and Wrong Ways

The most popular guideline for communicating bad news is SPIKES, a six-phase protocol with a special application for cancer patients. It is used in various countries (eg, the United States, France, and Germany) as a guide for this sensitive practice and for training in communication skills in this context. The SPIKES acronym refers to the following six recommended steps for delivering bad news:

• Setting: Set up the conversation.
• Perception: Assess the patient’s perception.
• Invitation: Ask the patient what he or she would like to know.
• Knowledge: Provide the patient with knowledge and information, breaking it down into small parts.
• Emotions: Acknowledge and empathetically address the patient’s emotions.
• Strategy and Summary: Summarize and define a medical action plan.

The lesson from SPIKES is that when a person experiences strong emotions, it is difficult to continue discussing anything, and they will struggle to hear anything. Allowing for silence is fundamental. In addition, empathy allows the patient to express his or her feelings and concerns, as well as provide support. The aim is not to argue but to allow the expression of emotions without criticism. However, these recommendations are primarily based on expert opinion and less on empirical evidence, due to the difficulty of studies in assessing patient outcomes in various phases of these protocols.

A recent study analyzed the differences in psychological distress between patients who received bad news over the phone vs those who received it in person. The study was a systematic review and meta-analysis.

The investigators examined 5944 studies, including 11 qualitative analysis studies, nine meta-analyses, and four randomized controlled trials.

In a set of studies ranging from moderate to good quality, no difference in psychological distress was found when bad news was disclosed over the phone compared with in person, regarding anxiety, depression, and posttraumatic stress disorder.

There was no average difference in patient satisfaction levels when bad news was delivered over the phone compared with in person. The risk for dissatisfaction was similar between groups.

Clinical Practice Guidelines

The demand for telemedicine, including the disclosure of bad news, is growing despite the limited knowledge of potential adverse effects. The results of existing studies suggest that the mode of disclosure may play a secondary role, and the manner in which bad news is communicated may be more important.

Therefore, it is paramount to prepare patients or their families for the possibility of receiving bad news well in advance and, during the conversation, to ensure first and foremost that they are in an appropriate environment. The structure and content of the conversation may be relevant, and adhering to dedicated communication strategies can be a wise choice for the physician and the interlocutor.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Communicating bad news to patients is one of the most stressful and challenging clinical tasks for any physician, regardless of his or her specialty. Delivering bad news to a patient or their close relative is demanding because the information provided during the dialogue can substantially alter the person’s perspective on life. This task is more frequent for physicians caring for oncology patients and can also affect the physician’s emotional state.

The manner in which bad news is communicated plays a significant role in the psychological burden on the patient, and various communication techniques and guidelines have been developed to enable physicians to perform this difficult task effectively.

Revealing bad news in person whenever possible, to address the emotional responses of patients or relatives, is part of the prevailing expert recommendations. However, it has been acknowledged that in certain situations, communicating bad news over the phone is more feasible.

Since the beginning of the COVID-19 pandemic, the disclosure of bad news over the phone has become a necessary substitute for in-person visits and an integral part of clinical practice worldwide. It remains to be clarified what the real psychological impact on patients and their closest relatives is when delivering bad news over the phone compared with delivering it in person.

Right and Wrong Ways

The most popular guideline for communicating bad news is SPIKES, a six-phase protocol with a special application for cancer patients. It is used in various countries (eg, the United States, France, and Germany) as a guide for this sensitive practice and for training in communication skills in this context. The SPIKES acronym refers to the following six recommended steps for delivering bad news:

• Setting: Set up the conversation.
• Perception: Assess the patient’s perception.
• Invitation: Ask the patient what he or she would like to know.
• Knowledge: Provide the patient with knowledge and information, breaking it down into small parts.
• Emotions: Acknowledge and empathetically address the patient’s emotions.
• Strategy and Summary: Summarize and define a medical action plan.

The lesson from SPIKES is that when a person experiences strong emotions, it is difficult to continue discussing anything, and they will struggle to hear anything. Allowing for silence is fundamental. In addition, empathy allows the patient to express his or her feelings and concerns, as well as provide support. The aim is not to argue but to allow the expression of emotions without criticism. However, these recommendations are primarily based on expert opinion and less on empirical evidence, due to the difficulty of studies in assessing patient outcomes in various phases of these protocols.

A recent study analyzed the differences in psychological distress between patients who received bad news over the phone vs those who received it in person. The study was a systematic review and meta-analysis.

The investigators examined 5944 studies, including 11 qualitative analysis studies, nine meta-analyses, and four randomized controlled trials.

In a set of studies ranging from moderate to good quality, no difference in psychological distress was found when bad news was disclosed over the phone compared with in person, regarding anxiety, depression, and posttraumatic stress disorder.

There was no average difference in patient satisfaction levels when bad news was delivered over the phone compared with in person. The risk for dissatisfaction was similar between groups.

Clinical Practice Guidelines

The demand for telemedicine, including the disclosure of bad news, is growing despite the limited knowledge of potential adverse effects. The results of existing studies suggest that the mode of disclosure may play a secondary role, and the manner in which bad news is communicated may be more important.

Therefore, it is paramount to prepare patients or their families for the possibility of receiving bad news well in advance and, during the conversation, to ensure first and foremost that they are in an appropriate environment. The structure and content of the conversation may be relevant, and adhering to dedicated communication strategies can be a wise choice for the physician and the interlocutor.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Communicating bad news to patients is one of the most stressful and challenging clinical tasks for any physician, regardless of his or her specialty. Delivering bad news to a patient or their close relative is demanding because the information provided during the dialogue can substantially alter the person’s perspective on life. This task is more frequent for physicians caring for oncology patients and can also affect the physician’s emotional state.

The manner in which bad news is communicated plays a significant role in the psychological burden on the patient, and various communication techniques and guidelines have been developed to enable physicians to perform this difficult task effectively.

Revealing bad news in person whenever possible, to address the emotional responses of patients or relatives, is part of the prevailing expert recommendations. However, it has been acknowledged that in certain situations, communicating bad news over the phone is more feasible.

Since the beginning of the COVID-19 pandemic, the disclosure of bad news over the phone has become a necessary substitute for in-person visits and an integral part of clinical practice worldwide. It remains to be clarified what the real psychological impact on patients and their closest relatives is when delivering bad news over the phone compared with delivering it in person.

Right and Wrong Ways

The most popular guideline for communicating bad news is SPIKES, a six-phase protocol with a special application for cancer patients. It is used in various countries (eg, the United States, France, and Germany) as a guide for this sensitive practice and for training in communication skills in this context. The SPIKES acronym refers to the following six recommended steps for delivering bad news:

• Setting: Set up the conversation.
• Perception: Assess the patient’s perception.
• Invitation: Ask the patient what he or she would like to know.
• Knowledge: Provide the patient with knowledge and information, breaking it down into small parts.
• Emotions: Acknowledge and empathetically address the patient’s emotions.
• Strategy and Summary: Summarize and define a medical action plan.

The lesson from SPIKES is that when a person experiences strong emotions, it is difficult to continue discussing anything, and they will struggle to hear anything. Allowing for silence is fundamental. In addition, empathy allows the patient to express his or her feelings and concerns, as well as provide support. The aim is not to argue but to allow the expression of emotions without criticism. However, these recommendations are primarily based on expert opinion and less on empirical evidence, due to the difficulty of studies in assessing patient outcomes in various phases of these protocols.

A recent study analyzed the differences in psychological distress between patients who received bad news over the phone vs those who received it in person. The study was a systematic review and meta-analysis.

The investigators examined 5944 studies, including 11 qualitative analysis studies, nine meta-analyses, and four randomized controlled trials.

In a set of studies ranging from moderate to good quality, no difference in psychological distress was found when bad news was disclosed over the phone compared with in person, regarding anxiety, depression, and posttraumatic stress disorder.

There was no average difference in patient satisfaction levels when bad news was delivered over the phone compared with in person. The risk for dissatisfaction was similar between groups.

Clinical Practice Guidelines

The demand for telemedicine, including the disclosure of bad news, is growing despite the limited knowledge of potential adverse effects. The results of existing studies suggest that the mode of disclosure may play a secondary role, and the manner in which bad news is communicated may be more important.

Therefore, it is paramount to prepare patients or their families for the possibility of receiving bad news well in advance and, during the conversation, to ensure first and foremost that they are in an appropriate environment. The structure and content of the conversation may be relevant, and adhering to dedicated communication strategies can be a wise choice for the physician and the interlocutor.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.

The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a 2-night period.

The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.

The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.

Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.

The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.

The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.

The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a 2-night period.

The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.

The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.

Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.

The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.

The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.

The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a 2-night period.

The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.

The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.

Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.

The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.

The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.

A version of this article appeared on Medscape.com.

Campaigners for greater transparency in medical science have reiterated calls for more to be done to avoid “medical research waste” after an investigation found that results from more than a fifth of clinical trials across five Nordic countries have never been made public.

A study found that results from 475 clinical trials in Denmark, Iceland, Finland, Norway, and Sweden — involving almost 84,000 participants — were never made public in any form.

Nonpublication of clinical trial results wastes public money, harms patients, and undermines public health, the researchers said. 

There is already a well-defined ethical responsibility to publish trial results. Article 36 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects states that “researchers have a duty to make publicly available the results of their research on human subjects,” and World Health Organization best practice protocols call for results to be uploaded onto trial registries within 12 months of trial completion.
 

Research Waste Is a ‘Pervasive Problem’

So, how and why do so many trials end up gathering dust in a drawer? The latest study, published February 5 as a preprint, evaluated the reporting outcomes of 2113 clinical trials at medical universities and university hospitals in Nordic countries between 2016 and 2019. It found that across the five countries, 22% of all clinical trial results had not been shared. Furthermore, only 27% of all trial results were made public, either on registries or in journals, within 12 months. Even 2 years after trials ended, only around half of results (51.7%) had been put into the public domain.

The authors concluded that missing and delayed results from academically-led clinical trials was a “pervasive problem” in Nordic countries and that institutions, funding bodies, and policymakers needed to ensure that regulations around reporting results were adhered to so that important findings are not lost.

Study first author, Gustav Nilsonne, MD, PHD, from the Department of Clinical Neuroscience at the Karolinska Institutet, Sweden, told this news organization: “Most people I talk to — most colleagues who are clinical scientists — tend to think that the main reason is that negative results are not as interesting to publish and therefore they get lower priority, and they get published later and sometimes not at all.”

Experts stressed that the problem is not confined to Nordic countries and that wasted medical research persists elsewhere in Europe and remains a global problem. For instance, a report published in the Journal of Clinical Epidemiology found that 30% of German trials completed between 2014 and 2017 remained unpublished 5 years after completion.
 

The Case for Laws, Monitoring, and Fines

Till Bruckner, PHD, from TranspariMED, which campaigns to end evidence distortion in medicine, told this news organization: “What is needed to comprehensively fix the problem is a national legal requirement to make all trial results public, coupled with effective monitoring, and followed by sanctions in the rare cases where institutions refuse to comply.” 

Dr. Nilsonne added: “We have argued that the sponsors need to take greater responsibility, but also that there needs to be somebody whose job it is to monitor clinical trials reporting. It shouldn’t have to be that we do this as researchers on a shoestring with no dedicated resources. It should be somebody’s job.”

Since January 31, 2023, all initial clinical trial applications in the European Union must be submitted through the EU Clinical Trials Information System. Dr. Bruckner said that “the picture is not yet clear” in Europe, as the first trial results under the system are not expected until later this year. Even then, enforcement lies with regulators in individual countries. And while Denmark has already indicated it will enforce the regulations, he warned that other countries “might turn a blind eye.”

He pointed out that existing laws don’t apply to all types of trials. “That means that for many trials, nobody is legally responsible for ensuring that results are made public, and no government agency has any oversight or mandate,” he said.

Outside the EU, the United Kingdom has helped lead the way through the NHS Health Research Authority (HRA), which registers trials run in the country. One year after a trial has been completed, the HRA checks to see if the results have been uploaded to the registry and issues reminders if they haven’t.

In an update of its work in January, the authority said that compliance had hovered at just below 90% between 2018 and 2021 but that it was working to increase this to 100% by working with stakeholders across the research sector.

Dr. Nilsonne considers the UK system of central registration and follow-up an attractive option. “I would love to see something along those lines in other countries too,” he said.
 

‘Rampant Noncompliance’ in the United States

In the United States, a requirement to make trial results public is backed by law. Despite this, there’s evidence of “rampant noncompliance” and minimal government action, according to Megan Curtin from Universities Allied for Essential Medicines (UAEM), which has been tracking the issue in the United States and working to push universities and others to make their findings available.

The US Food and Drug Administration (FDA) shares responsibility with the National Institutes of Health for enforcement of clinical trial results reporting, but the UAEM says nearly 4000 trials are currently out of compliance with reporting requirements. In January last year, the UAEM copublished a report with the National Center for Health Research and TranspariMED, which found that 3627 American children participated in clinical trials whose results remain unreported.

The FDA can levy a fine of up to $10,000 USD for a violation of the law, but UAEM said that, as of January 2023, the FDA had sent only 92 preliminary notices of noncompliance and four notices of noncompliance. “A clear difference between the EU field of clinical trial operation and US clinical trials is that there are clear laws for reporting within 12 months, which can be enforced, but they’re not being enforced by the FDA,” Ms. Curtin told this news organization.

The UAEM is pushing the FDA to issue a minimum of 250 preliminary notices of noncompliance each year to noncompliant trial sponsors.

Dr. Nilsonne said: “I do believe we have a great responsibility to the patients that do contribute. We need to make sure that the harms and risks that a clinical trial entails are really balanced by knowledge gain, and if the results are never reported, then we can’t have a knowledge gain.”
 

A version of this article appeared on Medscape.com.

Campaigners for greater transparency in medical science have reiterated calls for more to be done to avoid “medical research waste” after an investigation found that results from more than a fifth of clinical trials across five Nordic countries have never been made public.

A study found that results from 475 clinical trials in Denmark, Iceland, Finland, Norway, and Sweden — involving almost 84,000 participants — were never made public in any form.

Nonpublication of clinical trial results wastes public money, harms patients, and undermines public health, the researchers said. 

There is already a well-defined ethical responsibility to publish trial results. Article 36 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects states that “researchers have a duty to make publicly available the results of their research on human subjects,” and World Health Organization best practice protocols call for results to be uploaded onto trial registries within 12 months of trial completion.
 

Research Waste Is a ‘Pervasive Problem’

So, how and why do so many trials end up gathering dust in a drawer? The latest study, published February 5 as a preprint, evaluated the reporting outcomes of 2113 clinical trials at medical universities and university hospitals in Nordic countries between 2016 and 2019. It found that across the five countries, 22% of all clinical trial results had not been shared. Furthermore, only 27% of all trial results were made public, either on registries or in journals, within 12 months. Even 2 years after trials ended, only around half of results (51.7%) had been put into the public domain.

The authors concluded that missing and delayed results from academically-led clinical trials was a “pervasive problem” in Nordic countries and that institutions, funding bodies, and policymakers needed to ensure that regulations around reporting results were adhered to so that important findings are not lost.

Study first author, Gustav Nilsonne, MD, PHD, from the Department of Clinical Neuroscience at the Karolinska Institutet, Sweden, told this news organization: “Most people I talk to — most colleagues who are clinical scientists — tend to think that the main reason is that negative results are not as interesting to publish and therefore they get lower priority, and they get published later and sometimes not at all.”

Experts stressed that the problem is not confined to Nordic countries and that wasted medical research persists elsewhere in Europe and remains a global problem. For instance, a report published in the Journal of Clinical Epidemiology found that 30% of German trials completed between 2014 and 2017 remained unpublished 5 years after completion.
 

The Case for Laws, Monitoring, and Fines

Till Bruckner, PHD, from TranspariMED, which campaigns to end evidence distortion in medicine, told this news organization: “What is needed to comprehensively fix the problem is a national legal requirement to make all trial results public, coupled with effective monitoring, and followed by sanctions in the rare cases where institutions refuse to comply.” 

Dr. Nilsonne added: “We have argued that the sponsors need to take greater responsibility, but also that there needs to be somebody whose job it is to monitor clinical trials reporting. It shouldn’t have to be that we do this as researchers on a shoestring with no dedicated resources. It should be somebody’s job.”

Since January 31, 2023, all initial clinical trial applications in the European Union must be submitted through the EU Clinical Trials Information System. Dr. Bruckner said that “the picture is not yet clear” in Europe, as the first trial results under the system are not expected until later this year. Even then, enforcement lies with regulators in individual countries. And while Denmark has already indicated it will enforce the regulations, he warned that other countries “might turn a blind eye.”

He pointed out that existing laws don’t apply to all types of trials. “That means that for many trials, nobody is legally responsible for ensuring that results are made public, and no government agency has any oversight or mandate,” he said.

Outside the EU, the United Kingdom has helped lead the way through the NHS Health Research Authority (HRA), which registers trials run in the country. One year after a trial has been completed, the HRA checks to see if the results have been uploaded to the registry and issues reminders if they haven’t.

In an update of its work in January, the authority said that compliance had hovered at just below 90% between 2018 and 2021 but that it was working to increase this to 100% by working with stakeholders across the research sector.

Dr. Nilsonne considers the UK system of central registration and follow-up an attractive option. “I would love to see something along those lines in other countries too,” he said.
 

‘Rampant Noncompliance’ in the United States

In the United States, a requirement to make trial results public is backed by law. Despite this, there’s evidence of “rampant noncompliance” and minimal government action, according to Megan Curtin from Universities Allied for Essential Medicines (UAEM), which has been tracking the issue in the United States and working to push universities and others to make their findings available.

The US Food and Drug Administration (FDA) shares responsibility with the National Institutes of Health for enforcement of clinical trial results reporting, but the UAEM says nearly 4000 trials are currently out of compliance with reporting requirements. In January last year, the UAEM copublished a report with the National Center for Health Research and TranspariMED, which found that 3627 American children participated in clinical trials whose results remain unreported.

The FDA can levy a fine of up to $10,000 USD for a violation of the law, but UAEM said that, as of January 2023, the FDA had sent only 92 preliminary notices of noncompliance and four notices of noncompliance. “A clear difference between the EU field of clinical trial operation and US clinical trials is that there are clear laws for reporting within 12 months, which can be enforced, but they’re not being enforced by the FDA,” Ms. Curtin told this news organization.

The UAEM is pushing the FDA to issue a minimum of 250 preliminary notices of noncompliance each year to noncompliant trial sponsors.

Dr. Nilsonne said: “I do believe we have a great responsibility to the patients that do contribute. We need to make sure that the harms and risks that a clinical trial entails are really balanced by knowledge gain, and if the results are never reported, then we can’t have a knowledge gain.”
 

A version of this article appeared on Medscape.com.

Campaigners for greater transparency in medical science have reiterated calls for more to be done to avoid “medical research waste” after an investigation found that results from more than a fifth of clinical trials across five Nordic countries have never been made public.

A study found that results from 475 clinical trials in Denmark, Iceland, Finland, Norway, and Sweden — involving almost 84,000 participants — were never made public in any form.

Nonpublication of clinical trial results wastes public money, harms patients, and undermines public health, the researchers said. 

There is already a well-defined ethical responsibility to publish trial results. Article 36 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects states that “researchers have a duty to make publicly available the results of their research on human subjects,” and World Health Organization best practice protocols call for results to be uploaded onto trial registries within 12 months of trial completion.
 

Research Waste Is a ‘Pervasive Problem’

So, how and why do so many trials end up gathering dust in a drawer? The latest study, published February 5 as a preprint, evaluated the reporting outcomes of 2113 clinical trials at medical universities and university hospitals in Nordic countries between 2016 and 2019. It found that across the five countries, 22% of all clinical trial results had not been shared. Furthermore, only 27% of all trial results were made public, either on registries or in journals, within 12 months. Even 2 years after trials ended, only around half of results (51.7%) had been put into the public domain.

The authors concluded that missing and delayed results from academically-led clinical trials was a “pervasive problem” in Nordic countries and that institutions, funding bodies, and policymakers needed to ensure that regulations around reporting results were adhered to so that important findings are not lost.

Study first author, Gustav Nilsonne, MD, PHD, from the Department of Clinical Neuroscience at the Karolinska Institutet, Sweden, told this news organization: “Most people I talk to — most colleagues who are clinical scientists — tend to think that the main reason is that negative results are not as interesting to publish and therefore they get lower priority, and they get published later and sometimes not at all.”

Experts stressed that the problem is not confined to Nordic countries and that wasted medical research persists elsewhere in Europe and remains a global problem. For instance, a report published in the Journal of Clinical Epidemiology found that 30% of German trials completed between 2014 and 2017 remained unpublished 5 years after completion.
 

The Case for Laws, Monitoring, and Fines

Till Bruckner, PHD, from TranspariMED, which campaigns to end evidence distortion in medicine, told this news organization: “What is needed to comprehensively fix the problem is a national legal requirement to make all trial results public, coupled with effective monitoring, and followed by sanctions in the rare cases where institutions refuse to comply.” 

Dr. Nilsonne added: “We have argued that the sponsors need to take greater responsibility, but also that there needs to be somebody whose job it is to monitor clinical trials reporting. It shouldn’t have to be that we do this as researchers on a shoestring with no dedicated resources. It should be somebody’s job.”

Since January 31, 2023, all initial clinical trial applications in the European Union must be submitted through the EU Clinical Trials Information System. Dr. Bruckner said that “the picture is not yet clear” in Europe, as the first trial results under the system are not expected until later this year. Even then, enforcement lies with regulators in individual countries. And while Denmark has already indicated it will enforce the regulations, he warned that other countries “might turn a blind eye.”

He pointed out that existing laws don’t apply to all types of trials. “That means that for many trials, nobody is legally responsible for ensuring that results are made public, and no government agency has any oversight or mandate,” he said.

Outside the EU, the United Kingdom has helped lead the way through the NHS Health Research Authority (HRA), which registers trials run in the country. One year after a trial has been completed, the HRA checks to see if the results have been uploaded to the registry and issues reminders if they haven’t.

In an update of its work in January, the authority said that compliance had hovered at just below 90% between 2018 and 2021 but that it was working to increase this to 100% by working with stakeholders across the research sector.

Dr. Nilsonne considers the UK system of central registration and follow-up an attractive option. “I would love to see something along those lines in other countries too,” he said.
 

‘Rampant Noncompliance’ in the United States

In the United States, a requirement to make trial results public is backed by law. Despite this, there’s evidence of “rampant noncompliance” and minimal government action, according to Megan Curtin from Universities Allied for Essential Medicines (UAEM), which has been tracking the issue in the United States and working to push universities and others to make their findings available.

The US Food and Drug Administration (FDA) shares responsibility with the National Institutes of Health for enforcement of clinical trial results reporting, but the UAEM says nearly 4000 trials are currently out of compliance with reporting requirements. In January last year, the UAEM copublished a report with the National Center for Health Research and TranspariMED, which found that 3627 American children participated in clinical trials whose results remain unreported.

The FDA can levy a fine of up to $10,000 USD for a violation of the law, but UAEM said that, as of January 2023, the FDA had sent only 92 preliminary notices of noncompliance and four notices of noncompliance. “A clear difference between the EU field of clinical trial operation and US clinical trials is that there are clear laws for reporting within 12 months, which can be enforced, but they’re not being enforced by the FDA,” Ms. Curtin told this news organization.

The UAEM is pushing the FDA to issue a minimum of 250 preliminary notices of noncompliance each year to noncompliant trial sponsors.

Dr. Nilsonne said: “I do believe we have a great responsibility to the patients that do contribute. We need to make sure that the harms and risks that a clinical trial entails are really balanced by knowledge gain, and if the results are never reported, then we can’t have a knowledge gain.”
 

A version of this article appeared on Medscape.com.

A group of 16 Democratic legislators on the House Committee on Oversight and Reform has demanded in a letter that the drugmaker Pfizer present details on how the company is responding to shortages of the generic chemotherapy drugs carboplatin, cisplatin, and methotrexate.

In a statement about their February 21 action, the legislators, led by Rep. Jamie Raskin (D-Md.), the committee’s ranking minority member, described their work as a follow up to an earlier investigation into price hikes of generic drugs. While the committee members queried Pfizer over the three oncology medications only, they also sent letters to drugmakers Teva and Sandoz with respect to shortages in other drug classes.

A representative for Pfizer confirmed to MDedge Oncology that the company had received the representatives’ letter but said “we have no further details to provide at this time.”

What is the basis for concern?

All three generic chemotherapy drugs are mainstay treatments used across a broad array of cancers. Though shortages have been reported for several years, they became especially acute after December 2022, when an inspection by the US Food and Drug Administration (FDA) led to regulatory action against an Indian manufacturer, Intas, that produced up to half of the platinum-based therapies supplied globally. The National Comprehensive Cancer Care Network reported in October 2023 that more than 90% of its member centers were struggling to maintain adequate supplies of carboplatin, and 70% had trouble obtaining cisplatin, while the American Society of Clinical Oncology published clinical guidance on alternative treatment strategies.

What has the government done in response to the recent shortages?

The White House and the FDA announced in September that they were working with several manufacturers to help increase supplies of the platinum-based chemotherapies and of methotrexate, and taking measures that included relaxing rules on imports. Recent guidance under a pandemic-era federal law, the 2020 CARES Act, strengthened manufacturer reporting requirements related to drug shortages, and other measures have been proposed. While federal regulators have many tools with which to address drug shortages, they cannot legally oblige a manufacturer to increase production of a drug.

What can the lawmakers expect to achieve with their letter?

By pressuring Pfizer publicly, the lawmakers may be able to nudge the company to take measures to assure more consistent supplies of the three drugs. The lawmakers also said they hoped to glean from Pfizer more insight into the root causes of the shortages and potential remedies. They noted that, in a May 2023 letter by Pfizer to customers, the company had warned of depleted and limited supplies of the three drugs and said it was “working diligently” to increase output. However, the lawmakers wrote, “the root cause is not yet resolved and carboplatin, cisplatin, and methotrexate continue to experience residual delays.”

Why did the committee target Pfizer specifically?

Pfizer and its subsidiaries are among the major manufacturers of the three generic chemotherapy agents mentioned in the letter. The legislators noted that “pharmaceutical companies may not be motivated to produce generic drugs like carboplatin, cisplatin, and methotrexate, because they are not as lucrative as producing patented brand name drugs,” and that “as a principal supplier of carboplatin, cisplatin, and methotrexate, it is critical that Pfizer continues to increase production of these life-sustaining cancer medications, even amidst potential lower profitability.”

The committee members also made reference to news reports of price-gouging with these medications, as smaller hospitals or oncology centers are forced to turn to unscrupulous third-party suppliers.

What is being demanded of Pfizer?

Pfizer was given until March 6 to respond, in writing and in a briefing with committee staff, to a six questions. These queries concern what specific steps the company has taken to increase supplies of the three generic oncology drugs, what Pfizer is doing to help avert price-gouging, whether further oncology drug shortages are anticipated, and how the company is working with the FDA on the matter.

A group of 16 Democratic legislators on the House Committee on Oversight and Reform has demanded in a letter that the drugmaker Pfizer present details on how the company is responding to shortages of the generic chemotherapy drugs carboplatin, cisplatin, and methotrexate.

In a statement about their February 21 action, the legislators, led by Rep. Jamie Raskin (D-Md.), the committee’s ranking minority member, described their work as a follow up to an earlier investigation into price hikes of generic drugs. While the committee members queried Pfizer over the three oncology medications only, they also sent letters to drugmakers Teva and Sandoz with respect to shortages in other drug classes.

A representative for Pfizer confirmed to MDedge Oncology that the company had received the representatives’ letter but said “we have no further details to provide at this time.”

What is the basis for concern?

All three generic chemotherapy drugs are mainstay treatments used across a broad array of cancers. Though shortages have been reported for several years, they became especially acute after December 2022, when an inspection by the US Food and Drug Administration (FDA) led to regulatory action against an Indian manufacturer, Intas, that produced up to half of the platinum-based therapies supplied globally. The National Comprehensive Cancer Care Network reported in October 2023 that more than 90% of its member centers were struggling to maintain adequate supplies of carboplatin, and 70% had trouble obtaining cisplatin, while the American Society of Clinical Oncology published clinical guidance on alternative treatment strategies.

What has the government done in response to the recent shortages?

The White House and the FDA announced in September that they were working with several manufacturers to help increase supplies of the platinum-based chemotherapies and of methotrexate, and taking measures that included relaxing rules on imports. Recent guidance under a pandemic-era federal law, the 2020 CARES Act, strengthened manufacturer reporting requirements related to drug shortages, and other measures have been proposed. While federal regulators have many tools with which to address drug shortages, they cannot legally oblige a manufacturer to increase production of a drug.

What can the lawmakers expect to achieve with their letter?

By pressuring Pfizer publicly, the lawmakers may be able to nudge the company to take measures to assure more consistent supplies of the three drugs. The lawmakers also said they hoped to glean from Pfizer more insight into the root causes of the shortages and potential remedies. They noted that, in a May 2023 letter by Pfizer to customers, the company had warned of depleted and limited supplies of the three drugs and said it was “working diligently” to increase output. However, the lawmakers wrote, “the root cause is not yet resolved and carboplatin, cisplatin, and methotrexate continue to experience residual delays.”

Why did the committee target Pfizer specifically?

Pfizer and its subsidiaries are among the major manufacturers of the three generic chemotherapy agents mentioned in the letter. The legislators noted that “pharmaceutical companies may not be motivated to produce generic drugs like carboplatin, cisplatin, and methotrexate, because they are not as lucrative as producing patented brand name drugs,” and that “as a principal supplier of carboplatin, cisplatin, and methotrexate, it is critical that Pfizer continues to increase production of these life-sustaining cancer medications, even amidst potential lower profitability.”

The committee members also made reference to news reports of price-gouging with these medications, as smaller hospitals or oncology centers are forced to turn to unscrupulous third-party suppliers.

What is being demanded of Pfizer?

Pfizer was given until March 6 to respond, in writing and in a briefing with committee staff, to a six questions. These queries concern what specific steps the company has taken to increase supplies of the three generic oncology drugs, what Pfizer is doing to help avert price-gouging, whether further oncology drug shortages are anticipated, and how the company is working with the FDA on the matter.

A group of 16 Democratic legislators on the House Committee on Oversight and Reform has demanded in a letter that the drugmaker Pfizer present details on how the company is responding to shortages of the generic chemotherapy drugs carboplatin, cisplatin, and methotrexate.

In a statement about their February 21 action, the legislators, led by Rep. Jamie Raskin (D-Md.), the committee’s ranking minority member, described their work as a follow up to an earlier investigation into price hikes of generic drugs. While the committee members queried Pfizer over the three oncology medications only, they also sent letters to drugmakers Teva and Sandoz with respect to shortages in other drug classes.

A representative for Pfizer confirmed to MDedge Oncology that the company had received the representatives’ letter but said “we have no further details to provide at this time.”

What is the basis for concern?

All three generic chemotherapy drugs are mainstay treatments used across a broad array of cancers. Though shortages have been reported for several years, they became especially acute after December 2022, when an inspection by the US Food and Drug Administration (FDA) led to regulatory action against an Indian manufacturer, Intas, that produced up to half of the platinum-based therapies supplied globally. The National Comprehensive Cancer Care Network reported in October 2023 that more than 90% of its member centers were struggling to maintain adequate supplies of carboplatin, and 70% had trouble obtaining cisplatin, while the American Society of Clinical Oncology published clinical guidance on alternative treatment strategies.

What has the government done in response to the recent shortages?

The White House and the FDA announced in September that they were working with several manufacturers to help increase supplies of the platinum-based chemotherapies and of methotrexate, and taking measures that included relaxing rules on imports. Recent guidance under a pandemic-era federal law, the 2020 CARES Act, strengthened manufacturer reporting requirements related to drug shortages, and other measures have been proposed. While federal regulators have many tools with which to address drug shortages, they cannot legally oblige a manufacturer to increase production of a drug.

What can the lawmakers expect to achieve with their letter?

By pressuring Pfizer publicly, the lawmakers may be able to nudge the company to take measures to assure more consistent supplies of the three drugs. The lawmakers also said they hoped to glean from Pfizer more insight into the root causes of the shortages and potential remedies. They noted that, in a May 2023 letter by Pfizer to customers, the company had warned of depleted and limited supplies of the three drugs and said it was “working diligently” to increase output. However, the lawmakers wrote, “the root cause is not yet resolved and carboplatin, cisplatin, and methotrexate continue to experience residual delays.”

Why did the committee target Pfizer specifically?

Pfizer and its subsidiaries are among the major manufacturers of the three generic chemotherapy agents mentioned in the letter. The legislators noted that “pharmaceutical companies may not be motivated to produce generic drugs like carboplatin, cisplatin, and methotrexate, because they are not as lucrative as producing patented brand name drugs,” and that “as a principal supplier of carboplatin, cisplatin, and methotrexate, it is critical that Pfizer continues to increase production of these life-sustaining cancer medications, even amidst potential lower profitability.”

The committee members also made reference to news reports of price-gouging with these medications, as smaller hospitals or oncology centers are forced to turn to unscrupulous third-party suppliers.

What is being demanded of Pfizer?

Pfizer was given until March 6 to respond, in writing and in a briefing with committee staff, to a six questions. These queries concern what specific steps the company has taken to increase supplies of the three generic oncology drugs, what Pfizer is doing to help avert price-gouging, whether further oncology drug shortages are anticipated, and how the company is working with the FDA on the matter.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.