• News
    • Featured Articles
    • Product News
    • E-News
  • Magazine
    • About us
    • Digital edition
    • Archived issues
    • Media kit
    • Submit Press Release
  • White Papers
  • Events
  • Suppliers
  • E-Alert
  • Contact us
  • Subscribe newsletter
  • Search
  • Menu Menu
International Hospital
  • AI
  • Cardiology
  • Oncology
  • Neurology
  • Genetics
  • Orthopaedics
  • Research
  • Surgery
  • Innovation
  • Medical Imaging
  • MedTech
  • Obs-Gyn
  • Paediatrics

Archive for category: Featured Articles

Featured Articles

Special pricing available on SONY 4K andk 3D monitors

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47264_IHE-Artwork-Ampronix-2018.jpg 1500 1060 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:30:00Special pricing available on SONY 4K andk 3D monitors

Point of Care Testing: Complementing the Laboratory

, 26 August 2020/in Featured Articles /by 3wmedia

Point-of-care testing (POCT) is typically described as a clinical test which is done at, or close to, the physical location of a patient. This could be at a patient’s home, in a pharmacy, a GP’s office or an in-hospital bed site. POCT typically consists of portable devices and instruments, which return results quickly. As a result, POCT permits immediate intervention or treatment.
POCT can also be defined usefully by specifying what it is not. In this case, a POCT is simply a test that is not analysed in a laboratory. POCT short circuits many steps involved in the latter. It eliminates the need to collect a specimen, transfer it to the lab, perform the test, and transmit results back to the provider.
POCT is increasingly used to diagnose and manage a range of diseases, from chronic conditions such as diabetes to acute coronary syndrome (ACS). Recent additions include genetic tests.

Driven by miniaturisation
The POCT era is considered to have begun in the 1970s, with a test to measure blood glucose levels during cardiovascular surgery. In 1977, a rapid pregnancy test called ‘epf’ became the first POCT for use wholly outside a hospital.
Since the late 1980s, one of the key drivers of POCT has been product miniaturization, with increasingly sophisticated and ever-smaller mechanical and electrical components integrated onto chips that can analyse biological objects at the microscale. The pace of miniaturization has accelerated at a breakneck speed in recent years, to mobile handheld and wearable POCT devices. These can be inte-
grated with other applications within a healthcare facility, or aid patients in monitoring and self-management of chronic conditions.

Wide product range, but handful of tests dominate
The most widely-used POCTs include “blood glucose testing, blood gas and electro-
lytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, faecal occult blood analysis, food pathogens screening, haemoglobin diagnostics, infectious disease testing and cholesterol screening.” Nevertheless, just three tests – urinalysis by dipstick, blood glucose and urine pregnancy – are believed to account for the majority of POCT.

Comparisons with the lab
Beyond definition, the relationship of POCT to a laboratory is close for a very good reason. Most clinical cases for POCT use lab testing as a comparator. In other words, the first question that comes to many people when using POCT is whether its results match those of a laboratory. Although evidently quicker to obtain, is POCT as reliable? Another topic for comparison consists of the cost of POCT versus lab tests.

Costs: a vexed question

Even in the heady early days of POCT, there was awareness about potential cost downsides. One of the first efforts to address this question was a US study, published in 1994 in ‘Clinical Therapeutics’. [1] The study, by the Office of Health Policy and Clinical Outcomes at the Thomas Jefferson University Hospital in Philadelphia, sought to determine time and labour costs for POCT versus central laboratory testing on a cohort of 210 patients presenting to the emergency department.
The patients had blood drawn for a Chem-7 profile (sodium, potassium, chloride, carbon dioxide, blood urea nitrogen, glucose, and creatinine), or for cell blood count (CBC). Largely due to much quicker turnaround time (TAT), physicians reported that POCT would have resulted in earlier therapeutic action for 40 of 210, or 19 percent of patients. Costs for POCT were, however, over 50 percent higher, and also showed significant variability, depending on test volume. The authors speculated that increasing volumes of POCT would reduce costs “substantially.”

Volumes lower cost
The perception that POCT is much more expensive than a centralized laboratory persists. There are several reasons for this. Consumables generally cost more than tests done with automated laboratory instruments. On its part, POCT simply cannot achieve the scale economy associated with the latter. It also requires more staff downtime.
However, right from the early stages of POCT use, it seemed likely that unit costs could be reduced by increasing test volumes, as anticipated in the 1994 study by Jefferson University Hospital.
POCT was also to quickly demonstrate enhanced utility for certain kinds of tests. In 1997, a study at an Indiana hospital reported a near-halving in unit costs of panels, from USD 15.33 to USD 8.03, following POCT implementation for blood gases and electrolytes [2].

Levelling the field of play
One of the biggest hurdles in making cost comparisons of POCT with lab tests is the difficulty of levelling the playing field. It is also difficult to use such an exercise to draw generalised conclusions, since key conditions often vary significantly from one care facility to another. POCT is also complex to manage, and it is especially challenging to maintain regulatory compliance, especially in large institutions.
Though the cost of consumables is straightforward to determine, this is hardly so for labour.
Labour costs for a lab test are not limited to staff in the laboratory. They also include costs of staff in the pre-analysis phase, for phlebotomy, nursing and other services. Many of the latter entail administrative overheads. Typically, these would consist of formalities in the collection of phlebotomy supplies, the completion and submission of a test request, the labelling of tubes, specimen packaging and despatch.
In contrast, POCT eliminates most pre-analytic steps, along with associated staff costs and overheads. POCT can be undertaken by personnel who are not trained in clinical laboratory sciences.

Cost versus value
Although it seems to be common sense that POCT labour costs are significantly less than for a laboratory test, calculating this precisely requires a complex time-and-motion study which takes account of differences in wages and other costs for phlebotomists, nurses, administrative staff and medical technologists.
Unit product cost therefore reflects only a part of the overall equation, as far as justifying the case for a test is concerned. Indeed, many experts now urge for making assessments based on unit value rather than unit cost.
The role of TAT
With POCT, faster TAT promises better treatment, reduced patient stay, superior workflow and improved clinical outcomes. POCT is however less about reducing TAT than making results available in an optimal and clinically relevant time frame. This, in turn, is frequently dictated by conditions for which care is targeted as well as the setting in which it is delivered.
Delayed test results also impact upon cost in indirect ways. For instance, radiology departments use creatinine POCT before administering contrast agents, since patients with impaired renal function can develop contrast-induced kidney injury. This allows for quick decisions about patients and efficient use of costly CT scanners. If physicians had to wait for test results from a laboratory, the scanner would risk having to idle in a stand by status.

POCT can sometimes be only choice
Some tests have to be performed at point of care since there is no choice, in terms of time for transport to a lab.
One good example is an activated clotting-time test. This is used to monitor cardiac patients undergoing high-dose heparin therapy, whose blood immediately starts to clot after collection of a sample. Another is a POCT glucose test, where a quick result is crucial in determining insulin dosage for diabetic patients.
Elsewhere, whole blood cardiac-marker POCT tests in an A&E facility allow physicians to make rapid decisions on patients with acute coronary syndromes in terms of triage and disposition for observation, catheterization or transfer to a cardiac ICU.
Yet another example is a rapid flu test, used to identify patients who could benefit from antiviral therapy requiring administration as soon as possible after infection, in order to reduce symptomatic intervals. None of the above permit the wait times required for a lab test.

The grey zones
Still, there are grey zones where lab tests have advantages, which are non-negotiable under certain conditions.
One example is routine monitoring of international normalized ratios (INR) for patients on warfarin. The latter is used for prophylaxis against stroke and systemic embolism in patients with atrial fibrillation or mechanical heart valves. The goal of testing is to ensure that anticoagulant levels are appropriate. Over a certain threshold, there is a risk of bleeding, while below it, there is the danger of clotting.
While warfarin toxicity can result in life-threatening risk of bleeding, inappropriate warfarin dose reduction can lead to inadequate protection from a stroke or systemic embolism.
Lab-based testing entails the patient travelling to a GP, or having a caregiver come to take blood at the patient’s home, and doing this regularly. However, even a one-day TAT for the lab test can be a major problem in terms of warfarin dosage. The utility of POCT here seems clear. The GP can know the results and adjust the medication dosage immediately. In addition, POCTs can enable certain categories of patient to self-test and manage warfarin therapy.

Lab tests as gold standard
However, POCT tests can vary significantly from laboratory analysers. In the case of warfarin monitoring, this happens as INR values rise. Correction factors are also typically device- and institution-specific. They cannot be uniformly applied across institutions. Many clinicians therefore require POCT INRs which are greater than 5.0 to be confirmed with a venipuncture sample and a lab test.
Lab tests therefore remain a gold standard. Instrumentation in a laboratory provides robust analytics during a test, and includes a host of quality controls, from test strengths and timings to testing accuracy. These are incorporated into a laboratory information system (LIS) and stored in a patient case file. POCT simply cannot provide such a depth of information.

Gaps being closed
In brief, both POCT and laboratory testing have pluses and minuses. POCT provides definite advantages and reduce risk in some situations.
However, laboratory testing is more advanced, more closely follows scientific process and is fully integrated with the kinds of technical redundancies necessary to ensure greater accuracy and validation of records.
Nevertheless, gaps between the two are being closed, especially through software technology.
Some hospitals now have dedicated satellite labs in emergency rooms and outpatient facilities equipped with POCT.

[1]  https://www.ncbi.nlm.nih.gov/pubmed/7859247
[2] Bailey TM, Topham TM, Wantz S, et al. Laboratory process improvement through point-of-care testing. Jt Comm J Qual Improv 1997;23(7):362–80

https://interhospi.com/wp-content/uploads/sites/3/2020/08/shutterstock_1435535750.jpg 450 800 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:46Point of Care Testing: Complementing the Laboratory

Shaping the future of radiology with advanced imaging technologies

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47398_ADV-ECR-2019-210x297-International-hospital-PRINT.jpg 2000 1414 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:54Shaping the future of radiology with advanced imaging technologies

A helping hand for pediatric intensive care

, 26 August 2020/in Featured Articles /by 3wmedia

Doctors working in the eight-bed Pediatric Intensive Care Unit at the Ramón y Cajal University Hospital in Madrid use point-of-care ultrasound extensively to evaluate the condition of critically ill children, and find it essential to their work. Dr José Luis Vázquez Martínez, Head of UCIP at Hospital Ramón y Cajal, with over 25 years’ experience in pediatric intensive care medicine, explained.

Point-of-care ultrasound (POCUS) is used extensively in our unit, allowing comprehensive, head-to-toe assessment of critically ill children, including respiratory, oncology and post-operative cardiac patients, as well as those being treated for sepsis or multiple trauma. The POCUS approach allows not only an initial diagnosis, but also routine monitoring of treatment to see whether or not a patient’s condition changes, enabling alternative strategies to be implemented if there is no improvement.

POCUS helps pediatric doctors in many ways. For example, ultrasound scans enable evaluation of a patient’s hemodynamic state, looking at their heart function and blood volume to see if these factors are contributing to respiratory failure. Conversely, doctors can see if a lung problem, such as pneumonia, is affecting the heart. For a patient in a coma due to multiple trauma, ultrasound is used to look for signs of bleeding – a potential cause of unexplained anemia – and to assess the intracranial pressure. It is also used to monitor kidney function in children with blood pressure problems, and visualize intestinal indications of sepsis. In addition, ultrasound guidance can be used for endotracheal intubation. In short, broader applications that we did not anticipate until very recently.

We have used ultrasound in our PICU for more than a decade, and have always had SonoSite systems, upgrading them as new technology is introduced. In the beginning, when my knowledge was more limited, the aim was to perform clinical echocardiography but, when the SonoSite representative showed me the linear probe and the various techniques available, it was as if I was being shown electricity after using candles! It was amazing, a real turning point in the use of ultrasound, and everyone recognized it as a step forward in the pediatric intensive care world. For the patients, a major benefit of ultrasound is that exposure to radiation can be reduced. Before ultrasound, X-ray examinations were performed two or three times in the first few days after admission to try to establish the cause of the problem, often with limited success. With ultrasound, we can scan the patient as often as necessary, implementing treatment and monitoring its effect without exposing the child to more radiation.

In PICU, we consider an ultrasound system essential – there is nothing else that gives us so much information, so quickly and non-invasively – and today we have a dedicated Edge II ultrasound system with linear, including hockey stick, and adult and pediatric cardiac transducers. It is in constant demand and is a perfect fit for our work, fulfilling all our expectations. All my colleagues use it, and we are very satisfied with it. The system is high quality and ergonomic, and strikes a good balance between image quality and ease of use. It is also quick to boot up, which is crucial for an instrument that is frequently moved between different beds in the unit. Robustness is vital too; if a patient deteriorates, we may have to move any equipment surrounding the bed very quickly to create space to treat them. However careful you are, there is always the risk of unintentional knocks to the system.

A while ago someone said to me that they ‘sell ultrasound machines but don’t offer training’, but this view isn’t enough – it’s very short-sighted – training is very important. Ramón y Cajal pioneered the use of ultrasound in PICUs across Spain, and was the first hospital to offer external training courses for doctors from other facilities, initially focused on clinical echocardiography. Over time, this has expanded to include neuromonitoring, respiratory and abdominal monitoring. I acquired my ultrasound experience through a combination of external training in adult ultrasound and practical, hands-on learning, and am largely self-taught. If courses like these had been available when I started using ultrasound, I would have saved so much time.
FUJIFILM SonoSite is clearly committed to organising and supporting ultrasound training, and this is unquestionably a great benefit to the scientific community – long may it last!      

Today, we are seeing a boom in the use of ultrasound in pediatric care, as it non-invasively provides immediate information in situations where time is of the essence. Our advice to people attending our training courses who do not have – or have to share – an ultrasound system is to tell their hospital managers that, just like a ventilator, it is an essential piece of equipment for an intensive care unit.

www.sonosite.comwww.fujifilmholdings.com
https://interhospi.com/wp-content/uploads/sites/3/2020/08/IH180_Fujifilm-Sonosite_Dr-Jose-Luis-Vazquez.jpg 600 800 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:30:06A helping hand for pediatric intensive care

KIMES 2020 – 36th Korea International Medical & Hospital Equipment Show

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/KIMES_2020_IHE_Junior_revised_01.jpg 1457 1000 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:49KIMES 2020 – 36th Korea International Medical & Hospital Equipment Show

Sonosite ultrasound has led the market for the past 20 years

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47316_3058_20yr_ad_IH_Ad-297-x-210mm-v1.jpg 1500 1056 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:57Sonosite ultrasound has led the market for the past 20 years

VeinSight VS400

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/AD_IH_OUTPATIENT_SUPPLY.jpg 1415 1000 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:44VeinSight VS400

Reducing NICU noise improves wellbeing of infants

, 26 August 2020/in Featured Articles /by 3wmedia

Neonatal intensive care units can be noisy places which can disturb the sleep patterns of the youngest patients in the hospitals and have a negative effect on their health. In an effort to ameliorate this, some NICUs have set quiet times to limit exposure to noise. However, little was known about the effects of the ‘quiet time’ on infant health and it is only now according to a recent study in The Journal of the Acoustical Society of America that researchers have demonstrated its beneficial effect. The study, one of the first in this field, examined the effects of quiet time implementation in multiple NICUs on infants up to 18 months after implementation. They analysed how each NICU’s soundscape changed throughout the day and how this affected infant heart rates. They found that certain stressful pitches were actually quieter in respect to their effect on infant heart rates and that very loud sounds occurred less frequently with the result that quiet time throughout the day was longer. The results provide a sense of which features of quiet time policies have the largest impact on infants in NICUs and they recommend using quiet time protocols to help NICU patients in addition to implementing architectural noise reduction strategies in NICUs.
In a separate, but related study published in Sleep last year, researchers showed that preterm newborns sleep better in NICUs while hearing their mother’s voice. The study explored the possibility that infants’ exposure to their mother’s voice in the NICU could modulate the impact of noise in the NICU. The results indicate that newborns in a NICU were less likely to be awakened by noises when a recording of their mother’s voice was playing. The study also found that newborns born at or after 35 weeks’ gestation show sleep-wake patterns that appear to respond increasingly with age to recorded maternal voice exposure. Similar associations were not found for infants born before 35 weeks’ gestation. It appears that exposure to a mother’s voice recording may insulate NICU patients from some of the impact of unavoidable noise by reducing the likelihood of wakefulness during the highest peak noise levels. Because of this, the researchers suggest that for infants who are ill or born prematurely and may require extended care in a NICU during a time of critical brain development, interventions designed to improve sleep may need to be tailored according to gestational age. As such, the impact of playing a recording of a mother’s voice, reading a story for example, may have a more significant impact for newborns who are near term gestation than for more premature infants.

https://interhospi.com/wp-content/uploads/sites/3/2020/08/Editor_s_letter_Callan_Emery_headshot.jpg 1030 800 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:52Reducing NICU noise improves wellbeing of infants

Healthcare within reach

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47292_IHE_1811_MINDRAY.jpg 1500 1141 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:30:00Healthcare within reach

Elderly women: Neglected But Fast-Growing Demographic

, 26 August 2020/in Featured Articles /by 3wmedia

Elderly women account for a large part of the world’s population. The number of females aged 60 and over is on course to cross one billion in 2050. This would correspond to a tripling of the level from 335 million in 2000. Older women out-number older men, and this imbalance rises with age. Indeed,  the fastest growing sub-group among ageing women consists of those over 80. Globally, there are about 125 women for every 100 men in the over-60 age group. Among the over-80s, the gap is much higher, at 190 women for 100 men.

Longer but not necessarily healthier lives
The increase in number of elderly women has been accompanied by the growth of their very specific health needs. Although women in Europe outlive men by six years, the difference in healthy life expectancy is only nine months. In effect, their extra years are severely burdened by disease and ill health.
In spite of such facts, there is a remarkable lack of data specifically focused on the health of elderly women. For instance, figures from the European statistical service, Eurostat, show standardized death rates per 100,000 inhabitants for all women, and for women under-65. Although it would be possible to determine the figure for women greater than 65 years in age, it is remarkable that this is not provided on the Eurostat site.

Data limitations
In 2005, a group called Older Women Network Europe (OWN-Europe) observed that though there was an abundance of studies on ageing, there was little gender analysis of potentially major differences in health on ageing women versus ageing men.
Ironically enough, OWN-Europe’s own website (www.own-europe.org) has been taken over by an entity dedicated to promoting anti-cellulitis stockings in the Japanese language. The organisation itself has been subsumed into AGE Platform Europe, which is a forum promoting awareness about issues affecting the aged in general, rather than differences in issues and concerns between elderly women and elderly men. As noted, this was OWN-Europe’s critique to begin with.
Another organisation, Dublin-based European Institute of Women’s Health (EIWH) has since sought to fill this gap. Though also concerned with general women’s health issues, it has an elderly-focused approach on key topics of interest – for example, providing data-based position papers on specific risks to elderly women, as compared both to men and younger women, in areas such as dementia, breast cancer, cardiovascular disease etc.

Age-related risks for women
Differences in Eurostat cause-of-death rates for women under 65 years in age versus all women yield some interesting conclusions.
Diseases of the cardiovascular system (circulatory disease and heart disease) account for the largest share of deaths in elderly women in Europe, well ahead of cancer. Lung cancer results in about
65 percent higher deaths than breast cancer, with colorectal cancer only slightly behind.
There is a steep rise in the age-related risk of dying from cardiovascular disease (CVD). This is outweighed slightly by the much smaller rate of death from respiratory disease. The age-related risk increase is also marked in dying from diseases of the nervous system.  Once again, the risk of older women dying from lung cancer as compared to younger women is significantly higher than breast cancer, while the age-related growth in risk is also high for colorectal cancer.

Lack of attention: The CVD example
Attention to specific age-related health issues in women has been inadequate.
For example, though it has been long known that CVD is a significant cause of female death, women present different symptoms than men. For example, a heart attack in a woman is often confused with indigestion—not pain in the chest. Women are also less likely to seek or to be provided with medical help and to be properly diagnosed until late in the disease process. Such factors are believed to explain why women are less likely to survive a heart attack, particularly when treated by a male doctor.

Other scourges
On the other side of the spectrum are conditions such as osteoporosis and osteoarthritis, which do not result in death, but lead to chronic pain and limit quality of life. They do not get adequate attention, since they are seen as an inevitable part of ageing – or as less serious conditions than heart disease or cancer. Both osteoporosis and osteoarthritis have a high propensity for women.

Osteoporosis: early start for women
Osteoporosis, for example, is four times more common in women aged over 50 than in men. One of the reasons is that women have a lower peak bone mass and show a younger onset of bone loss compared with men – on average, by 10 years.
For women, rapid declines in bone mass occur in the 65-69 age group as opposed to 74-79 for men. A second factor playing a role here are the hormonal changes which occur at menopause; these can alter calcium composition in a woman’s body.
Meanwhile, initiatives like hormone replacement therapy (HRT), once widely used in the wealthier countries, have become mired in controversy. Recent studies suggest that rather than prevent heart disease after menopause as was originally believed, HRT is associated with an increased risk of stroke and heart disease among some ageing women.

Osteoarthritis in one of 5 elderly women, twice rate in men

Osteoarthritis too shows the above patterns. This degenerative joint disease is associated with ageing and principally affects the articular cartilage. It impacts on joints which have been stressed over the years – such as the fingers, the knees, hips, and the lower spine region. 80% of osteoarthritis patients have limitations in movement, and 25% cannot perform their major daily activities of life.
Globally, an estimated 18 percent of women aged over 60 years have symptomatic osteoarthritis, which is almost twice a rate of 9.6 percent reported in men. Moreover, the incidence of osteoarthritis in the 60-90 age group rises 20-fold in women as compared to 10-fold in men.

Osteoarthritis and CVD
Osteoarthritis, in particular, has serious implications for another major problem, namely CVD. Meanwhile, some studies have demonstrated a high prevalence of CVD in osteoarthritis patients. One found that 54% of people with knee and hip osteoarthritis had co-existing CVD.

Need for more research on women
The above observations underwrite a need for research on diseases and health conditions of concern to women in general, and elderly women in particular.
Although CVD is one of the best known examples of differences between the sexes in symptomatic and other responses to disease, there are other cases. For instance, among men and women smoking the same number of cigarettes, women are 20 to 70 percent more likely to develop lung cancer.
One of the first areas of attention is to increase the number of clinical trials dedicated to such issues and encourage the participation of women in trials.

After thalidomide, women discouraged in clinical trials

Low female representation in clinical trials became a structural problem after the US Food and Drug Administration (FDA) issued a guideline in 1977 banning most women of ‘childbearing potential’ from participating in clinical research studies. This was the result of drugs like thalidomide, which caused severe birth defects.
Nevertheless, few denied, even then, that new drugs were metabolized differently by men and women due to factors such as body size, fat distribution and the hormonal environment.
It soon also became apparent that even new life-saving drugs might not work as well in women as they did in men. Worse still was one study in 2001, which reported that female patients have a 1.5 to 1.7-fold greater risk of developing adverse drug reactions than men, due to gender-related differences in pharmacokinetics as well as immunological and hormonal factors.
In the three years 1997-2000, eight of the 10 drugs for which the FDA withdrew approval had harmful side effects for women.

US changes approach, but gap still large

In the late 1980s, the FDA issued new guidelines to encourage inclusion of more women in studies and in 1993, formally rescinded its policy discouraging women from participating in studies.
Additional studies between 2011 and 2013 evaluated the inclusion and analysis of women in federally-funded randomized clinical trials. The researchers found that most such US studies, which were not sex-specific, had an average enrolment of 37% women. However, almost two out of three studies did not specify their results by sex and did not explain why the influence of sex in their findings was ignored.

The European case
The situation is similar in Europe. For instance, in spite of the role of CVD in female mortality, a EuroHeart report found that women comprised only a third of CVD trial participants, while one of two studies did not report the results by gender. Until the 1990s, clinical research in Europe followed the US lead and focused mainly on men. As the US began to shift stance towards encouraging women in trials, Europe followed suit, using the Inter-national Conference on Harmonisation (ICH) as a vehicle. ICH guidelines require Phase I response data be obtained for relevant sub-populations “according to gender.” However, many of the require-ments offer opt-outs with wording like “if the size of the study permits,” or recommend that demographic subgroups be “examined.”

New Regulation on Clinical Trials

EU rules on clinical trials are due to be overhauled after a new Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises clinical trial assessment and supervision via a Clinical Trials Information System (CTIS), which will be maintained by the European Medicines Agency (EMA).
The Regulation was adopted in 2014, but will enter into force after the CTIS is certified through an independent audit. This is still ongoing.
The new Regulation recommends that “gender and age groups” which would use a medicinal product should participate in its clinical trials. However, it still leaves an opt-out if exclusion is “otherwise justified in the protocol”, although “non-inclusion has to be justified”.
In other words, the jury is still out.

https://interhospi.com/wp-content/uploads/sites/3/2020/08/shutterstock_125086058.jpg 533 800 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:16:482021-01-08 12:29:47Elderly women: Neglected But Fast-Growing Demographic
Page 99 of 102«‹979899100101›»

Latest issue of International Hospital

April 2024

4 July 2025

Everdrone expands world-first medical emergency drone network in Sweden

4 July 2025

Wireless implant breakthrough offers personalised chronic pain relief

3 July 2025

EEG-powered brain computer interface enables finger-level robotic hand control

Digital edition
All articles Archived issues

Free subscription

View more product news

Get our e-alert

The medical devices information portal connecting healthcare professionals to global vendors

Sign in for our newsletter
  • News
    • Featured Articles
    • Product News
    • E-News
  • Magazine
    • About us
    • Archived issues
    • Media kit
    • Submit Press Release

Beukenlaan 137
5616 VD Eindhoven
The Netherlands
+31 85064 55 82
info@interhospi.com

PanGlobal Media IS not responsible for any error or omission that might occur in the electronic display of product or company data.

Scroll to top

This site uses cookies. By continuing to browse the site, you are agreeing to our use of cookies.

Accept settingsHide notification onlyCookie settings

Cookie and Privacy Settings



How we use cookies

We may ask you to place cookies on your device. We use cookies to let us know when you visit our websites, how you interact with us, to enrich your user experience and to customise your relationship with our website.

Click on the different sections for more information. You can also change some of your preferences. Please note that blocking some types of cookies may affect your experience on our websites and the services we can provide.

Essential Website Cookies

These cookies are strictly necessary to provide you with services available through our website and to use some of its features.

Because these cookies are strictly necessary to provide the website, refusing them will affect the functioning of our site. You can always block or delete cookies by changing your browser settings and block all cookies on this website forcibly. But this will always ask you to accept/refuse cookies when you visit our site again.

We fully respect if you want to refuse cookies, but to avoid asking you each time again to kindly allow us to store a cookie for that purpose. You are always free to unsubscribe or other cookies to get a better experience. If you refuse cookies, we will delete all cookies set in our domain.

We provide you with a list of cookies stored on your computer in our domain, so that you can check what we have stored. For security reasons, we cannot display or modify cookies from other domains. You can check these in your browser's security settings.

.

Google Analytics Cookies

These cookies collect information that is used in aggregate form to help us understand how our website is used or how effective our marketing campaigns are, or to help us customise our website and application for you to improve your experience.

If you do not want us to track your visit to our site, you can disable this in your browser here:

.

Other external services

We also use various external services such as Google Webfonts, Google Maps and external video providers. Since these providers may collect personal data such as your IP address, you can block them here. Please note that this may significantly reduce the functionality and appearance of our site. Changes will only be effective once you reload the page

Google Webfont Settings:

Google Maps Settings:

Google reCaptcha settings:

Vimeo and Youtube videos embedding:

.

Privacy Beleid

U kunt meer lezen over onze cookies en privacy-instellingen op onze Privacybeleid-pagina.

Privacy policy
Accept settingsHide notification only

Sign in for our newsletter

Free subscription