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New service and business models are challenging the traditional role of a hospital – as a place where sick people are taken to get better. Instead, a growing body of evidence suggests that the key mission of future hospitals will be to help people to avoid falling ill, and to manage those that do in fundamentally different ways than at present. Such processes are principally driven by economic pressures and the promise of new technologies. However, patients are also playing a major role.
Patients more proactive
It has indeed been apparent for some time that patients are far less passive than they were in the past. In Britain, a study by the King’s Fund think-tank found patients wished to be far more involved in healthcare decisions. In addition, the study reported that patient satisfaction depended not just on medical outcomes, but also on being treated with dignity and respect.
Emerging technologies are seen as one way to enhance the patient experience, and several popular apps show how rapidly patients have moved to centre-stage. In the US, Heal, a smartphone app, lets patients search for physicians in a manner similar to Uber’s connecting passengers to drivers. Zocdoc, another tool for finding doctors, has added an artificial intelligence-powered Insurance Checker feature which lets patients select and verify insurance information as they are booking appointments. An app called Welloh goes beyond doctors to give users information about hospitals, pharmacies, care centres and other facilities. Clinical trials are also opening up to volunteers, thanks to an app called TrialReach, which helps patients find open clinical trials for specific medical conditions.
These new health access paradigms resonate strongly with younger patients. According to a report from Salesforce, over 70 percent want their physicians to adopt mobile health applications.
Apple integrating health apps
Evidence of the opportunities arising from enhanced patient participation comes from Apple, which plans to bring the current clutter of healthcare apps under one roof. Its new Health Records feature will allow users to see their records of allergies, immunizations, lab results, medications and other conditions in a single window and send notifications when any data is updated.
Big Data
One of the most promising and best known tools in the emerging technology arsenal is computing giant IBM’s Watson, which deploys artificial intelligence (AI) to collect and interpret vast amounts of data from medical literature in order to advise on best treatment options. Scores of other tools provide personalized treatment plans for cancer patients using the genetic background of their tumours, accompanied by analysis from tens of thousands of other, similar cases.
These kinds of innovations count on assimilating and interpreting what has come to be known as Big Data. The sources for this data, whose volume continues to grow by leaps and bounds, are many. They include clinical studies, prescriptions, radiological images and a host of other healthcare information.
The Internet of Things
One new source of data is from the Internet of Things. Connected medical devices such as insulin pumps and pacemakers pick up signals and automatically transmit information to networked computers, which allow physicians (and patients) to perform real-time monitoring.
An array of wearable devices to track vital signs are another fast-growing source of medical data. On an individual basis, this may not amount to much. However, when the data is provided by millions of users, its size becomes staggering, as does its potential for providing insights.
Cloud computing
Such a burgeoning mass of data is being generated asynchronously, processed and stored by different machines on multiple platforms. Making it usable is hardly simple.
One promising answer to such a challenge lies in cloud computing technology, which has dramatically reduced the cost of data storage, as well as the time required to process and transfer the data to multiple users at different locations. For patients needing to visit a lot of specialists, the accessibility of their data from a variety of locations can be indispensable.
The Electronic Health Record
One of cloud computing’s biggest areas of impact may be the electronic health record (EHR), one of whose goals was in fact to address the above challenge – patient data access in real time by different specialists.
The EHR has generally failed to meet expectations (and over-expectations). In both Europe and the US, the EHR’s key technical/operational limitation was that clinical and financial data could not be easily shared and exchanged among providers – as many had assumed or otherwise hoped for. In the US, EHRs have generally also failed to meet levels of reporting that support the ‘meaningful use’ requirements of pay-for-performance programmes.
Cloud computing seems likely to give a new lease of life to the EHR. Server-based EHRs always run the risk of system failure, which would prevent access to critical patient data until the server has been restored. Such a scenario does not concern cloud-based EHRs. In addition, cloud services are encrypted and provide security. Cloud-based EHRs also reduce entry barriers to adoption by transferring responsibility for confidential patient information to specialized vendors.
Design and hospital re-purposing
The impact of such developments are reaching into the very design of a hospital. Christopher Shaw, Chair of a professional organization called Architects for Health and founder of the design firm Medical Architecture, believes there is a growing mismatch between the physical infrastructure of a hospital and the nature of activities expected to be required over the coming decades.
One key question here is the future of hospital buildings – whether to renovate and incrementally redesign structures or start afresh. Indeed, even as popular imagination associates future hospitals with robotic doctors, another equally beguiling scenario consists of individualized medicine, extending to some forms of surgery, carried out at home.
Hub-and-spoke models
The reality may lie in between, at least in the foreseeable future. One of the most likely scenarios might be a hub-and-spoke hospital model. Its inside tier would consist of academic medical centres serving larger populations and focused on acute care. The middle tier would be an intermediate-care hospital, located in smaller cities or larger towns and providing longer-term rehabilitation and nursing support. The outer tier would be comprised of polyclinics for outpatient diagnostics and elective care, referred from primary care physicians. At the periphery would be the patient’s home, with telemedicine treatment, and possibly some form of tele-surgery assisted by paramedical professionals on the scene. Some of the latter may well be robots.
Telehealth
After many false starts, telehealth technology is now on the edge of take-off – helping allocate care to patients more efficiently, by eliminating the need to visit hospitals, when they do not have a need to access concentrated multi-disciplinary expertise.
Telehealth is also seen as a means to bring patients back more quickly to their homes. Indeed, there is a considerable body of evidence which suggests that the sooner patients begin recovery at home, the more quickly they heal.
Telehealth is not only being pushed by technology but also pulled by economics. In the US, for example, healthcare providers of diabetic patient care have to contend with value-based measures. As a result, they are becoming increasingly dependent on real-time data from remote glucose monitors. Telehealth allows patients to be more engaged, and participate with physicians in ensuring better outcomes, by adhering to insulin or other medications.
Emerging models – examples
The challenge facing the emerging healthcare model lies in the best way to integrate resources, delivery and support mechanisms, and the need to avoid duplication. However, there are encouraging signs from several parts of the world.
In the US, Westchester Medical Center Health Network (WMC Health), is an example of the emerging hub-and-spoke hospital model. The core of the system consists of a 1,500-bed facility headquartered in Valhalla, New York, which is the only facility for complex interventions and procedures. Buttressing this are six (intermediate) hospitals, as well as several polyclinics and medical campuses. The system covers a population of more than 3 million people spread over 15,000 square kilometres.
In Europe, there are several efforts to redefine hospital design. In a variation of hub and spoke, Guy’s Hospital at London has developed its cancer centre as a stack of ‘villages’, one atop another, with each providing a different service (radiotherapy, chemotherapy, etc.).
Certain hospitals have sought to move in the opposite direction, bringing a full range of services to patients in one room or area. In Veldhoven, the Netherlands, a new Woman-Mother-Child Center at Maxima Hospital provides prenatal, delivery, postnatal and breastfeeding support services from one room.
UMC+ in Maastricht, NL
Some of the most radical efforts to address the redefinition of the hospital are being explored in the Netherlands, at Medical University Centre+ (UMC+) in Maastricht.
In late 2009, the departments of Dermatology and Orthopedics at UMC+ started out on separate tracks of what is called ‘design thinking’. Each department independently developed and implemented new care and financing systems, closely adapted to what they saw as the real needs of their patients, and combining specialities, which had been traditionally separated.
The key mission at UMC+ is to avoid pushing strategy down individual departments, which have highly specific patient groups, processes and technologies, and instead build strategy bottom up, involving inputs from across the staffing chain.
Nevertheless, the aim of design thinking is to also generate organizational change. Over time, several other departments began applying the methodologies pioneered by Dermatology and Orthopedics, creating a new hospital healthcare model.
Over time, the UMC+ model is transforming healthcare focused on rehabilitation, to preventive public health and development. The shift has also changed the role of the Board. Directors no longer set out strategies, but make communication possible between different departments. The Board aims to ensure that different departments do not seek to reinvent the wheel, and instead continuously develop and implement internal best practices.
The challenge of demographics
Nevertheless, many challenges still lie ahead. While Internet- and smartphone-friendly millennials are clearly going to benefit from new hospital care models, the bulk of hospital and healthcare needs for the next decade or two lie in the elderly. According to a Partners HealthCare study in 2016, few seniors obtain information or accomplish healthcare-related tasks online. Only 16 percent of seniors said they used the Internet to obtain health information, while just 7 percent contacted physicians online.
Primum non nocere (first, do not harm) remains a basic tenet of medical practice. Unfortunately, the complexities of modern medicine, the large pool of available medications as well as the multiplication of technical procedures combined with the frequent difficulty of reaching definite diagnoses and the high number of medical professionals taking care of a single patient have resulted in a growing number of medical errors, a significant part of which prove fatal for the patient. Data on the number of deaths caused by medical errors are not readily obtainable, nevertheless a number of recent studies in the US have reported figures greater than 200,000 deaths per year. For example, a patient safety expert team from John Hopkins University has calculated that over 250,000 deaths are caused by medical error in the US, based on an analysis of medical death rate data over an eight-year period. This figure was published last May in the BMJ and places medical error as the third highest cause of death, accounting for 10% of all US deaths. For the healthcare industry, this translates into about six potentially preventable deaths per year per US hospital, definitely not good statistics. The situation is somewhat similar in Europe, even if there aren’t any official figures at the EU level as Eurostat doesn’t list medical error as a possible cause of death since its statistics – like those of the US CDC – rely on the medical information contained on death certificates and on the coding of causes of death according to the WHO International Classification of Diseases (ICD) codes. Results from German studies on patient safety show that close to 20,000 deaths are caused by preventable adverse events in the country’s hospitals. These deaths cover a wide range of preventable causes, including hospital-acquired infections, embolisms, surgical errors, delay in diagnosis (especially for pediatric patients) and misdiagnosis – the latter probably ranking quite high even if very difficult to detect in research. Apart from deaths, there is a much bigger number of cases, up to 20-fold higher, where people suffer from serious adverse effects, sometimes for the rest of their lives. In addition to the individual harm incurred, there is also a high cost for society that includes additional healthcare expenditure, social costs and loss of economic capacity. Evidence shows that up to 70% of the harm caused by medical errors can be prevented through comprehensive systematic approaches to patient safety. At the hospital level, there is an urgent need for action, not least by physicians – they should be the first to recognize that every single death caused by a preventable adverse effect is one too many.
Conventional or B-mode ultrasound has been used as a diagnostic imaging tool for over four decades. Over the last few years, however, ultrasound systems have witnessed a blizzard of developments in their underlying technology. This has catalysed a significant change in the patterns of ultrasound usage vis-a-vis other, older imaging modalities, especially in terms of concerns about the latter – for example, radiation risk in X-rays and computer tomography (CT), and cost for both CT and magnetic resonance imaging (MRI).
Technology drivers
The ultrasound market is largely driven by innovations in underlying technologies and more sophisticated software algorithms, which allow manufacturers to offer smaller, more powerful and complex systems.
Key developments include an acceleration in processing speed and enhancement in the quality of diagnostic images – coupled to advances in contrast-enhanced imaging and precision in the timing of image capture. This has been accompanied by a sharp reduction in noise-to-signal ratios in the final data to optimize spatial, contrast and temporal resolution, including rotatable views for better visualization.
GE’s cSound technology, for example, offers CT level image quality based on advanced algorithms that capture much larger amounts of data than possible previously (by some estimates, about a DVD worth of data per second). The technology also makes pixel-by-pixel selections of the most precise information to display.
Developments in transducers, beam formation
Ultrasound has also made quantum leaps in factors such as transducer sensitivity and beam formation. For example, line-by-line imaging in beamformers has been replaced in some systems by large zone acquisitions, allowing users to view examinations in greyscale and colour Doppler. Meanwhile, retrospective imaging makes it possible to process raw data multiple times, while retention of channel domain data allows for patient-specific imaging.
Because of all the above, clinicians are able to use ultrasound to image blood perfusion and blood flow in vessels with diameters of 2 mm and less, with small vessel beds displayed via Doppler flow false-colour 3-D or greyscale reconstructions. The result is better assessments of organ perfusion, which have traditionally been difficult on ultrasound.
Commodification trends
Take-up of ultrasound has also been recently boosted by a growing commodification trend. Certain categories of ultrasound have become relatively inexpensive, mobile and less demanding of power. Mobility-related innovations include portable hand-held devices, and more recently, the world’s first wireless transducer. Even some low-end machines are now enabled for full bi-directional communication with electronic medical records.
As healthcare reforms and budgetary pressures favour use of cost-effective solutions, this has led to especially sharp growth in the use of low- and mid-range ultrasound systems. It is now commonplace, for example, to see ultrasound systems in a recovery room, next to hospital beds, or equipping NGOs at health outreach projects in developing countries.
For many hospitals, this kind of product/technology mix makes sense, since not all patients require the sophisticated features offered by high end machines, while their smaller, inexpensive counterparts provide solutions for an everyday challenge faced by most hospitals – workflow bottlenecks.
High-end remains motor for new applications
At the other end, the high-end segment is leading innovation not only in ultrasound technologies, but driving the overall medical imaging market, too. Despite their cost, the advanced features of premium systems have moved ultrasound well beyond traditional applications such as ob/gyn to interventional cardiology and internal medicine. Several ER clinicians, for instance, now routinely utilize ultrasound for echocardiograms and abdominal imaging, while radiologists and surgeons use it to guide needle placement or perform bone sonometry.
Some cutting-edge areas – such as matrix transducers – remain ensconced in the premium category. Matrix transducers have direct relevance to two fast-emerging applications, namely volumetric ultrasound and 3-D/4-D applications.
Key developments
Given below is an overview of key recent developments in ultrasound systems.
Mobility and Ergonomics
Ergonomics and mobility are being addressed by vendors in order to differentiate their systems and grow user volumes. Some surveys suggest that over three out of four of ultrasound users experience work-related pain, with a fifth of these suffering a career-ending injury.
New-generation ultrasound systems stand out in terms of design. Most are noiseless to permit sonographers to minimize distraction and focus on the exam, with settings customized and organized depending on clinical preferences.
Some have slanted bodies to prevent users hitting their knees or feet on the machine, with keyboards that can be raised or lowered depending on user height, probes that are shaped to the human palm and rotatable LCD monitors for sharing the display with colleagues. Other innovations include the possibility of use in both sitting and standing positions, with memory features to accommodate different users.
Some recent ultrasound machines have tablet-sized touchscreen-based interfaces, which significantly reduces the reach and steps (in some cases by 15-20%) in order to start and complete an exam. This enables faster workflow. Touchscreens allow users to tap in order to start functions, pinch and drag to zoom in and out, and swipe to expand the image. Some vendors offer exam presets, with several enhanced functions such as continuous wave Doppler or transducers.
Miniaturization
As discussed below, there is an increase in the use of ultrasound as an alternative to CT and MRI in many point-of-care (PoC) settings. One of the reasons for the trend is mobility as well as increasing miniaturization. Smaller ultrasound machines provide solutions to concerns about cables or wheeling bulky machines around patient rooms, and address tight space demands in key hospital settings such as the operating room. Compact models can be transported by being wheeled or atop a cart.
In some cases, smaller portable machines can also be moved between departments within a hospital or clinic – on a user’s back.
Enhanced quality drives ultrasound to point of care
Ultrasound images today are available with far-higher resolutions than in the early 2000s, when most physicians were used to pictures being fuzzy. One of the key reasons is enhancement in real-time computer processing of images.
Superior image quality has also driven ultrasound to the point-of-care (PoC) setting – both for diagnostic and interventional procedures. PoC ultrasound is now widely available in operating theatres and emergency rooms. Between 2010 and 2013, anesthesiologists are reported to have doubled the use of ultrasound procedures, and ultrasound is also far more common today in certain interventional procedures such as image-guided biopsies and ablations, previously dominated by CT and MRI.
Volumetric ultrasound development
Volumetric ultrasound allows superior characterizing of tissue and the performance of procedures with far greater accuracy.
Ultrasound was previously only able to capture a single imaging plane, but it can currently acquire volumes. This is because transducers which enable the acquisition of real-time volumes of tissue and allow imaging in multiple planes such as the transverse and sagittal have recently become available. For instance, transducers can detect the altered speed of high-frequency sound waves through adipose layers versus other tissue, and make the system aware of increased adipose content.
Though several new-generation transducers remain expensive, in areas where they make a difference, the added price tag is becoming justified. For instance, high-resolution matrix transducers are finding use in interventional cardiology applications such as trans-esophageal echocardiogram (TEE) and 4D imaging.
3-D/4-D imaging
While 2-D continues to be widely used in clinical applications, recent technological advances such as matrix transducers have been enabling factors and triggered interest in 3-D and 4-D ultrasound.
3-D/4-D ultrasound has a more rapid acquisition rate of datasets and subsequent improved image visualization.
4-D imaging consists of the three spatial dimensions as well as the element of time. It projects a cinematographic, motion picture view of an organ or a specific part of an organ, and is emerging as the next generation in advanced imaging.
In combination with advanced visualization functions, 4-D ultrasound aids complex surgical applications and interventional procedures. Multiplanar reconstructed (MPR) images are now available for review in the same manner as CT and MR scans.
Leading imaging vendors already offer 4-D imaging products – across all modalities, PET/CT, MRI and ultrasound. However, 4-D ultrasound is capturing a great deal of interest in applications where ultrasound has already made a case for itself, due to cost, mobility or radiation concerns.
The close connection between 4-D and ultrasound dates back to cutting edge efforts in the early 1980s, when a Duke University team determined that although MRI was faster, ultrasound was the closest to “achieving 3D real time acquisition.” The researchers, led by Dr. Olaf von Ramm, developed a single-transmit, multiple-receive ultrasound scanner called Explosocan to increase data bandwidth.
Elastography
One of the most revolutionary technologies in ultrasound consists of elastography, which utilizes B-mode ultrasound to measure the mechanical characteristics of tissues, which are then overlaid on the ultrasound image. This provides physicians the ability to view stiffer and softer areas inside of tissue, with image quality and clinical outcomes equivalent to X-Ray, MRI, and CT.
Elastography techniques include strain elastography and shear wave elastography (SWE). It has begun proving its use in the characterization of thyroid nodules, lymph nodes and indeterminate breast lumps as well as the detection of prostate cancer. None of these were achievable via conventional ultrasound.
The application which has generated maximum attention is liver fibrosis staging. Biopsies are not only invasive but carry bleeding and infection risks. Elastography, which can be repeated as often as required, is being seen as a way to get the data needed by clinicians to diagnose and stage liver diseases without the associated complications. Elastography is also used to predict complications in patients with cirrhosis.
SWE in particular is also seen as a tool to assist in earlier detection of conditions such as Hepatitis C, and both fatty liver and alcoholic liver disease. Alongside lab studies, it offers a means to closely monitor the impact of treatment and assess if the liver will normalize. For many hepatologists, fighting a liver condition before Stage 4 cirrhosis provides a good chance of reversibility.
SWE can also provide information on which Hepatitis C patients might benefit from viral therapy.
From smartphone apps to AI: the future
App-based ultrasound have recently been showcased. These use transducers connecting via a USB port to a mobile device and a downloadable app. The transducer performs data acquisition, processing and image reconstruction. The result is an ultrasound feature in a consumer-grade smartphone.
Some vendors have launched artificial intelligence systems to enhance speed and automatically take image volume data from 3-D echo to recreate optimized diagnostic views. In cardiac echo in particular, the result offers major potential by permitting reproducibility of imaging.
Nevertheless, such cutting edge technologies are still in their infancy. Only time and user experience will determine their eventual success.
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.
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.
April 2024
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.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:
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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:
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.U kunt meer lezen over onze cookies en privacy-instellingen op onze Privacybeleid-pagina.
Privacy policy