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3 years, 5 months ago

Minimally invasive spine surgery and computer assisted navigation systems

HealthPad
Directory:
Neurosurgery
Tags:
CAN systems
commentary
computer assisted navigation systems
minimal access spinal surgery
MISS
spine surgery
  • Over the past 2 decades minimally invasive surgery and computer assisted navigation (CAN) systems have significantly changed spine surgery
  • Minimally invasive spine surgery (MISS) has become a significant subspeciality accounting for ~50% of all spine surgeries undertaken in the US
  • Together MISS and CAN systems promise enhanced precision, improved outcomes, and lower costs
  • CAN systems provide surgeons with improved visibility of the operating site, but emit hazardous radiation that can cause cancer
  • Spine surgery appears to be winning the challenge to increase the development of minimally invasive surgery while decreasing harmful radiation in the operating room
  • MISS is positioned to grow and increase its market share but faces some headwinds
 
- Low back pain and the global spine industry - 
 
Minimally invasive spine surgery and computer assisted navigation systems
 
Minimally invasive spine surgery (MISS) requires only a small incision and uses specialized instruments and techniques that minimize cutting and results in minimal damage of body tissue. The technique serves the increasing prevalence of degenerative spinal disorders, attributed to sedentary lifestyles of aging populations, which have helped to drive the growth of a global spinal implants and devices market. In addition to the increased availability of biologics and customizable implants and the refinement of operative techniques, the development of MISS has been supported by advances in imaging and navigation technologies that make surgical targets virtual on a monitor to improve the accuracy and precision of surgical interventions. Today, there is a growing body of research demonstrating MISS’s advantages over the traditional open approach.  However, computer assisted navigation (CAN) systems tend to emit harmful ionizing radiation that can cause cancer. Reducing radiation in the OR while improving the quality of image guidance is expected to fuel further growth of MISS.
 
 In this Commentary

This Commentary focuses on minimally invasive spine surgery and computer assisted navigation systems. Two technologies, which have changed the landscape of modern spine surgery and offer potential benefits for both patients and surgeons. Has MISS reached its market saturation? If not, what will affect the speed and extent of its further adoption? 
 
Minimally invasive and open spine surgery

Over the past 2 decades, MISS has become a significant subspeciality and currently accounts for ~50% of all spine surgeries undertaken in the US. It is positioned to increase its influence over the next decade but faces some headwinds.

As a general principle, it is preferable to intrude as little as possible when carrying out a surgical procedure to minimise damage to surrounding tissue and to speed up recovery time. Many spine procedures that once required invasive operations (open surgery) have been replaced with MISS techniques.

Open spine surgery typically involves relatively long incisions down the back to give the surgeon the best view of, and access to, the anatomy. During such procedures, it is sometimes necessary to cut through and move aside muscles and tendons to reach the affected area, which can cause damage to these tissues and prolong recovery.

In MISS the surgeon makes a small incision and then inserts a device called a tubular retractor, a stiff, tube-shaped tool that creates a tunnel to the problem area of the spine by gently pushing aside the muscle and soft tissue around the affected area. The surgeon can then put small tools through the tunnel to work on the spine and use a special microscope to view real-time X-ray images of the spine. This approach results in less damage to the muscles and soft tissues that surround the spine, which leads to a more expedited recovery.

MISS has gained popularity both with patients and clinicians and has become increasingly feasible for the management of a range of spinal disorders. Progress has been made in the development of a direct lateral approach [from the side] as well as improvements of tubular retractors. Common spine surgery treatments available through minimally invasive methods include degenerative disc disorders, herniated discs, lumbar spinal stenosis, spinal deformities such as scoliosis, spinal infections, spinal instability including spondylolisthesis, vertebral compression fractures, and spinal tumours. In 2020, MISS procedures accounted for ~50% of all spine surgeries performed in the US, which had increased from ~16% in 2012.

According to David Bell, a consultant neurosurgeon at King’s College Hospital, London, who specialises in complex spine surgery, MISS significantly improves the patient experience by, “reducing the size of the incision and the amount of tissue manipulation . . .  It also minimises post-operative discomfort, cuts infection rates, lessens blood loss and reduces a patient’s recuperation time”. See video below.
 
 
The evidence

There is a growing body of research to support the benefits of MISS, which include: (i) reduced trauma to muscles and soft tissue, (ii) better cosmetic results from smaller incisions, (iii) less blood loss, (iv) reduced risk of infection, (v) faster recovery time and less rehabilitation, (vi) diminished reliance on pain medications, and (vii) reduced hospital stays. A further perceived benefit is the increasing range of MISS undertaken in outpatient settings. Such benefits are likely to fuel the refinement of surgical techniques based on patient outcomes, and lead to the growth of MISS.
 
However, not all studies are so positive about the benefits of MISS. A 2017 review of 17 randomized controlled trials, which compared MISS against open procedures for three common disorders, concluded that, “the evidence do not support MISS over open surgery for cervical or lumbar disc herniation”. The study suggests that there were some advantages for transforaminal lumbar interbody fusion (TLIF), [a procedure that melds the front and back sections of the spine through a posterior approach], but “at the cost of higher revision rates, higher readmission rates and more than twice the amount of intraoperative fluoroscopy”. [an imaging technique employed to improve intraoperative visualization of the operating field, which emits hazardous radiation]. The study concludes that, “Regardless of patient indication, MISS exposes the surgeon to significantly more radiation”. 

Two papers published in the January 2020 edition of the Journal of Spine Surgery report on a global survey of 430 surgeons to assess the extent of MISS and the training surgeons receive. The response rate was significant at 67%. 33% of respondents were neurosurgeons, 55% orthopaedic surgeons and 12% were surgeons with other postgraduate training. One research paper concludes that, “endoscopic spinal surgery is now the most commonly performed MISS technique”, and the other suggests that, “very few MISS surgeons are fellowship trained but attend workshops and various meetings suggesting that many of them are self-thought. Orthopaedic surgeons were more likely to implement endoscopic spinal surgery into the routine clinical practice”.
A review of the state of MISS reported in the June 2019 edition of the Journal of Spine Surgery confirms MISS as a significant subspeciality, “evidenced by the large and constantly growing body of literature on this topic”, and driven by “significant advancements in imaging and navigation technologies, refinement of operative techniques, availability of biologics and customizable implants, and most importantly, evidence of feasibility, efficacy, safety and value, compared to traditional approaches as demonstrated by the current literature”.
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If spine surgery fails to relieve low back pain why is it increasing?


 
Unmistakably, over the past two decades, MISS has become increasingly feasible, efficient, and popular. An important question is, how fast is MISS advancing? There is a paucity of research, which addresses this question. However, a global survey of spine surgeons published in the January 2020 edition of the Journal of Spine Surgery provides some insights. Findings suggest there are regional variations in the acceptance and utilization of MISS. The study surveyed 586 spine surgeons in 5 major regions of the world, which yielded 292 usuable responses: a significant response rate of ~50%. 70% of spine surgeons in Asia and South America thought MISS was accepted into mainstream spinal surgery in their practice areas compared to 63% of spine surgeons in North America, 53% in Europe and 50% in Africa & the Middle East. The percentage of spine surgeons that reported using MISS was higher: Asia (97%), Europe and South America (89%), and Africa & the Middle East (88%). Surgeons in North America reported the lowest rate of MISS implementation globally.  
 
Although innovations and techniques in MISS have continued to develop over the past decade, a significant percentage (~50% in the US) of surgeons are understood to use open surgical techniques. Reasons for this include: (i) lack of adequate surgeon training and experience, (ii) the steep learning curve needed for MISS, (iii) inadequate hospital resources and (iv) the patchiness of research on the benefits of MISS. It seems reasonable to suggest that such factors affect the adoption rate of MISS. But perhaps the most significant factor influencing the speed of its adoption will be the rate of development of robotic surgical systems. An understanding of the impact of these factors will help producers hone their strategies and business models.
 
Computer assisted navigation systems

A common therapy to correct spinal disorders is fusion, which melds together two or more vertebrae so that they heal into a single, solid bone. Spinal fusion surgeries use implants of biocompatible materials, such as titanium, as well as rods, plates, screws, and interbody cages and account for the largest segment of the global spine market.
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Low back pain, spine surgery and market shifts
During spinal fusion procedures, pedicle screws are used for spinal fixation, stability, and fusion. The incorporation of such screws into spine surgery in the early 1960s was a significant advance because it offered stability and decreased rates of pseudarthrosis [failure of a fractured bone to heal] compared to previous methods. However, subsequent studies suggested that there was a percentage of pedicle screws inaccurately placed, which could harm adjacent structures and potentially have mechanical, neurological, and vascular consequences for patients.
Image guidance systems were a noteworthy development in spine surgery to reduce the morbidity associated with the mispositioning of pedicle screws and today such systems are used widely. Fluoroscopy, an early guidance method, provided real-time X-ray imaging for guiding interventional procedures, which resulted in more accurate placement of screws, but such systems emitted hazardous ionizing radiation that surgeons, patients, and OR staff were subjected to. Any spine surgery that is visualized with fluoroscopy can involve 10 to 12X higher amounts of radiation from the use of X-rays compared to non-surgical procedures. Compared to a hip surgeon, a spine surgeon can experience 50X more harmful emissions over the course of a professional career and this has been linked to the development of cancers. Reducing radiation exposure is an important challenge.
 
Guided systems and reduced radiation

Newer intraoperative navigation modalities have been found to reduce radiation exposure significantly compared to traditional fluoroscopic guided percutaneous surgical techniques, and have become an important addition in spine surgery. Real-time image guidance, along with continuous computation and scan integration by the navigation system, allows a surgeon to visualize a comprehensive 3D picture of the operating site. Intraoperative computerized tomography (CT) scans [the use of X-rays and a computer to create detailed images of the operating site], together with infrared and other optical guidance technologies have substantially increased the accuracy and precision of spine surgeons to place pedicle screws. 
 
One such enhanced guidance system is ultralow radiation imaging (ULRI) coupled with image enhancement and instrument tracking (IE/IT). This is a new image modifier that allows a computer to show real-time movement of an instrument as it is adjusted, mimicking live fluoroscopy, but without continuous radiation production. Recent research suggests that ULRI-IE/IT systems, “can dramatically reduce radiation output and the number of images acquired and time needed to perform fluoroscopic procedures”. 
 
There are numerous FDA approved advanced CAN systems but let us briefly describe some popular ones. The Airo Mobile Intraoperative CT-based Spinal Navigation system was approved by the FDA in 2013, and developed by Brainlab, a privately held German MedTech company headquartered in Munich. The technology is one of the pioneers of advanced surgical navigation platforms and has many similarities to other CAN systems. It uses a mobile circular scanner attached to the operating table for 360° imaging, and a scanning stereotactic camera, which uses a set of three coordinates for instrument registration. Research published in the July 2018 edition of the Journal of Neurosurgery suggests that the Airo “mobile CT scanner reduced the rate of screw repositioning, which enhanced patient safety and diminished radiation exposure for patients, but it did not improve overall accuracy compared to that of a mobile 3D platform”.
 
Another popular system is Medtronic’s Stealth Station Spine Surgery Imaging and Surgical Navigation with O-arm, a portable imaging device that fits over the surgical table to take images of the operating field. This uses similar technology to Brainlab’s Airo, but opens at 90° to allow for mobilization around the patient. A third system is produced by Ziehm Imaging, another German company, which specializes in the development and manufacture of mobile C-arms [imaging devices that can be used flexibly in operating rooms]. In 2015, the company received FDA approval for the Ziehm Vision FD Vario 3D with NaviPort Integration. This is an intuitive technology, which obtains images via a 190° rotation with a C-arm around the patient and provides surgeons with, “crystal-clear and distortion-free 3D images for maximum intraoperative visualization of anatomical structures”. However, if its reference clamps are moved after the initial registration process, repeat CT scanning is required to re-register the clamps. Stryker’s SpineMask Tracker and SpineMap Software system overcome this problem by gluing its reference trackers to patients.
 
With the widespread use of CAN systems in spine surgery there is an increasing number of studies, which demonstrate the advantages of such technologies. For example, two large meta-analyses suggest that CAN systems significantly increase the accuracy of pedicle screw placement compared to freehand placement. Research also suggests that patients who undergo CAN pedicle screw placement have lower complication rates than those who undergo freehand placement.
 
Notwithstanding, findings of a global survey conducted in 2013 and reported in the September 2019 edition of The Spine Journal suggest that ~78% of surgeons still use two-dimensional fluoroscopy during spine surgery. Despite the improved accuracy and reduced radiation provided by advanced computer-assisted spine navigation systems. This could be associated with costs, prolonged operative times, and their cumbersome nature.
 
Machine-vision image guided surgery system

7D Surgical, a Toronto based company that develops advanced optical technologies, has sought to overcome challenges inherent in traditional CAN systems by developing a machine-vision image guided surgery platform, [FLASH™]. The technology employs a satellite-based global positioning system (GPS), to create a 3D image of a patient’s anatomy, and uses visible light coupled with machine-vision algorithms that eliminate exposure to intraoperative radiation. Other benefits of 7D’s system include its rapid set up time and its minimal workflow disturbance. The fact that its navigation camera is integrated into the surgical light, eliminates the need to stop surgery and position supplemental surgical equipment, thereby allowing for continuous access to the surgical field. Further, and unique to FLASH™, is the fact that its reference clamp can be repositioned, and images re-registered within ~20 seconds. This facilitates seamless clinical applicability and reverses many of the drawbacks of preceding navigation systems. In May 2021, SeaSpine, a Nasdaq traded spine company, announced the acquisition of 7D in a deal valued at US$110m. In July 2021 SeaSpine received FDA approval of 7D’s advanced guidance system for MISS.
 
Takeaways

Over the past two decades, MISS has had a significant impact and established itself as a subspeciality throughout the world. Although it is difficult to calculate, it appears that ~50% of spine surgeries could still be open procedures. This suggests that strategic questions facing producers include whether MISS will expand further, and if so, at what speed. This Commentary suggests some factors, which are likely to impede the adoption rate of MISS. However, perhaps the most significant challenge to MISS is not the prevalence of open surgery, but the rapid rise and adoption of robotic surgical systems. Research published in the January 2020 edition of the Journal of the American Medical Association on the trends in the adoption of robotic surgery concludes, “Hospitals that launched robotic surgery programs had a broad and immediate increase in the use of robotic surgery, which was associated with a decrease in traditional laparoscopic minimally invasive surgery”. Robotic surgical systems in spine surgery is the subject of a forthcoming Commentary.
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3 years, 5 months ago

If spine surgery fails to relieve low back pain why is it increasing?

HealthPad
Directory:
Neurosurgery
Tags:
commentary
complex spine surgery
LBP
low back pain
lumbar spinal fusion
spine fusion
  • Surgery has become a common therapy for low back pain (LBP) and degenerative disc disorders, but it often fails to relieve pain
  • The incidence rates of spine surgery are high and increasing and contribute to a US$10bn global spinal implant and devices market
  • We attempt to explain a paradox: If spine surgery fails to relieve LBP why is it increasing?
 
  
If spine surgery fails to relieve low back pain why is it increasing?
 
 
Low back pain (LBP) is a common age-related condition. In 2017, its point prevalence was ~7.5% of the global population, or ~0.58bn people. The condition is associated with degenerative disc disorders and is a leading cause of most years lived with disability. Spinal fusion is a common neurosurgical or orthopaedic surgical treatment to correct degenerative spinal disorders that can present as LBP. The procedure joins small bones in your spine (vertebrae), and can be performed at any level in your spine. The basic idea is to fuse together two or more vertebrae so that they heal into a single, solid bone. Such procedures have fuelled a global spinal implant and devices industry valued at ~US$10bn, growing at a compound annual growth rate (CAGR) of ~5% and concentrated in wealthy nations; the US, the EU-27 and Japan. Spinal fusion accounts for the largest share of this market, and is projected to reach ~US$8.5bn by 2026, exhibiting a CAGR of ~3.6%.
 
LBP is challenging to diagnose, and effective treatment is elusive, but surgical therapies have become commonplace with a significant proportion failing to relieve pain. So, why is spine surgery increasing? 
 
In this Commentary
 
Surgery may be able to fix the condition of degenerative disc disorders, but not eliminate pain. After spine surgery, a percentage of patients still experience pain, called ‘failed back syndrome’, which is characterized by a continuation of pain and an inability to return to normal activities. This has led to the paradox: If spine surgery fails to relieve LBP why is it increasing? We suggest 7 factors, acting in concert, help to explain this paradox, but stress that the evidence we present is circumstantial.
 
1. Clinical guidelines for LBP
 
Clinical practice guidelines are developed by multi-disciplinary teams of health professionals using an evidence-based approach, combining the best research available with expert consensus on best practice. In the UK, the National Institute for Health and Care Excellence. (NICE) is the body responsible for producing such guidelines. In the US the Institute of Medicine (IOM) first recommended the development of guidelines in 1990. Soon afterwards, several professional healthcare organizations such as the North American Spine Association (NASS) began producing their own guidelines for specific disorders. For this Commentary we use clinical guidelines provided by NICE and NASS.

As a first line therapy for LBP, NICE recommends a treatment package of, “exercise in all its forms, - e.g., stretching, strengthening, aerobics or yoga - advice and education, and if necessary, the inclusion of manual and psychological therapies”.

According to Spine Health, in the US therapies for LBP and degenerative disc disorders, “are primarily to reduce baseline pain and prevent pain flare-ups as much as possible. Most cases of degenerative disc pain are manageable through a combination of pain management methods, exercise/physical therapy, and lifestyle modifications”.

NASS 2020 guidelines for the ‘Diagnosis and Treatment of Low Back Pain’ pose 12 critical questions on the efficacy of the use of surgical treatment versus medical/interventional treatment, and conclude that it is unable to answer the questions because of the dearth of evidence. Here inter alia is a flavour of the questions posed by NASS:
  • Q In patients with LBP, does surgical treatment versus medical/interventional treatment alone decrease the duration of the pain, decrease the intensity of the pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
  • Q In patients undergoing surgery for low back pain, which fusion technique [the question lists 5 common techniques] results in the best outcomes for the following: decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?  
  • Q In patients undergoing fusion surgery for low back pain, does the use of bone growth stimulators  (versus fusion alone), decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
  • Q In patients undergoing fusion surgery for low back pain, does the use of BMP [bone morphogenetic proteins] (versus fusion alone), decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
  • Q In patients with LBP are there predictive factors, which determine the benefit of initial treatment with surgical intervention versus initial medical/interventional treatment?
NASS answers all 12 questions with the same statement: “A systematic review of the literature yielded no studies to adequately address this question”. This emphasises the absence of clinical evidence to confidently determine efficacious surgical therapies for LBP. NASS stresses that its guidelines are not intended to be viewed as a “standard of care”, but as “recommendations to assist in delivering optimum, efficacious treatment and functional recovery from nonspecific low back pain”.
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Low back pain, spine surgery and market shifts
2. Poor prognostic indicators for spinal surgery
 
This dearth of evidence makes therapy decisions challenging for clinicians. A study published in the 2018 edition of the Asian Spine Journal suggests that a proportion of the large and increasing spine fusion surgeries performed to reduce LBP and degenerative disc disorders fails because of weak prognostic indicators. Researchers stress that, “spine surgeons need to be well aware of the many poor prognostic indicators for spinal surgery”. The lack of high-quality evidence to support the use of spinal fusion for LPB fosters disagreement among physicians as to when spinal fusion should be performed. 
 
 In the video below Nick Thomas, a consultant neurosurgeon at King’s College Hospital, London, describes some of the challenges of poor prognostic indicators for LBP: “Dilemmas of managing low back pain arise because we (clinicians) have precious few pre-operative investigations that give us a clear idea as to whether a spinal fusion may or may not work. When an MRI is taken it can be very difficult to determine whether the degenerative discs one sees on the scan are normal age-related changes or whether they truly reflect a problem that might be generating the back pain”, says Thomas.
 
 
Such dilemmas in the management of LBP are not made easier by the fact that there are few studies, which compare spinal fusion to a placebo procedure. Most spine surgery research compares one fusion technique to another or to a form of non-surgical treatment. According to a study published in the March 2020 edition of The Lancet , “Over the past 10 years there has been increasing recognition of the importance of the placebo effect, particularly how strong this effect could be for a surgical procedure that involves high-intensity medical care, strong analgesia, and often physiotherapy”. Findings of recent placebo-controlled surgical trials for common vertebroplasty procedures [a procedure for stabilizing compression fractures in the spine], in which special cement is injected into a fractured vertebra, “have been shown to be largely ineffective, but continue to be in common use”. Further, randomised clinical studies, which are regarded as providing the highest-quality evidence, suggest that spinal fusion has little advantage over a well-structured rehabilitation programme for LBP.
 
A study published in the December 2018 edition of the Journal of Internal Medicine analysed data from 33 randomized controlled trials and other studies comparing spinal fusion to nonoperative solutions for LBP and degenerative spine conditions, and concluded that, “The overwhelming evidence simply doesn’t support spinal fusion (and its high costs and risks) for back pain and degenerative spine conditions over nonoperative solutions”. A 2019 WHO Bulletin entitled ‘Care for low back pain: can health systems deliver?’ suggests that, “many healthcare systems are not designed to support physical and psychological therapies for LBP”, and stresses that, “major international clinical guidelines now recognize that many people with low back pain require little or no formal treatment”.
 
3. Uncertainties of diagnosing LBP
 
Adding to poor prognostic indicators are the difficulties of diagnosing LBP. The aetiology of LBP is rarely precisely identified. Findings also suggest that a pathoanatomical diagnosis of LBP can only be made in ~5% to 7% of patients. LBP in patients where no such diagnosis is possible is often labelled, unscientifically, “chronic LBP”.
 
A 2016 study suggests that in ~80% to 95% of patients with LBP the cause cannot be determined despite the existence of sophisticated imaging techniques and a plethora of diagnostic tests. It seems reasonable to suggest that challenges associated with diagnosing LBP could provide tacit support for clinicians to continue carrying out surgical procedures they were trained to perform.
 
4. Rapidly ageing populations
 
A rapidly increasing global geriatric population is a significant factor driving the growth of the spinal fusion market. According to the United Nations, ~16% of the world’s population will be ≥65 by 2050. In North America and Europe, ~25% of their respective populations will be aged ≥65 by 2050. Common disorders of old age include LBP and degenerative disc disorders.
 
Age is significant because most spinal fusion procedures are performed on individuals ≥60 living in wealthy nations. This age cohort is the fastest-growing demographic in the principal spine markets of the US, Western Europe, and Japan. For example, the US has ~49m people (~15% of the population) who are aged ≥65. This cohort is projected to reach ~84m by 2050. The EU-27 has ~90m people (~20% of the population) ≥65. By 2050 the EU population ≥65 is expected to reach ~130m. The population structure of the UK is similar to that generally observed in the EU-27 with ~12m people aged ≥65, ~18.5% of the population, which is projected to double by 2050. Japan has the oldest population in the world with ~36m people (~29% of the population) who are ≥65. By 2025, Japan’s ≥65 population is expected to decrease to ~33m, but the percentage of the population ≥65 is projected to increase to ~32%. It seems reasonable to suggest that these vast and rapidly increasing older population cohorts are significant drivers of the growth of age-related LBP and the consequent increasing incidence rates of spine surgeries.

Global life expectancy has continued rising and is expected to reach 77 years by 2050, up from 70 in 2015. The number of people ≥65, who account for most spine surgeries, will climb by >60% in the next 15 years: from ~0.6bn in 2015 to ~1bn by 2030. The phenomena of aging and shrinking populations, means that every year, a shrinking pool of working-age people are forced to support an expanding pool of ageing patients with LBP and degenerative disc disorders. In the medium to long term such support seems unsustainable.
 
5. Obesity
 
The prevalence of LBP in individuals ≥65 who are also obese is significantly higher than in people who are of average weight. Not only are the populations in the principal spine markets ageing, but they are also experiencing rising incidence rates of obesity. According to the World Health Organisation, obesity throughout the world has nearly tripled since 1975. Today, there are ~2bn adults overweight, of those, ~650m are obese [body mass index (BMI) ≥30 kg/m²]. In England ~28% of adults are obese and a further 36% are overweight. In the US, 43% of people ≥60 is obese. From 2000 to 2018, the prevalence of obesity in the US increased from 31% to 42%, and the prevalence of extreme obesity [BMI ≥40 kg/m²] increased from 5% to 9%. 
 
6. High costs of spine surgeries
 
Most spine surgeries in the US have been covered by health insurance operating a fee-for-service model. A future Commentary describes how this model is changing. Notwithstanding, fee-for-service has meant that healthcare providers have been able to charge significant amounts for their services and oblige insurance companies to reimburse them, while inflicting minimal costs on patients. Although there is a paucity of studies which analyse recent trends in spinal fusion volume, utilization, and reimbursements, Medicare [a US national health insurance programme] payment trends have seen a decreasing allocation of reimbursements for surgeons generally. Research published in the October 2020 edition of The Spine Journal suggests that this, “may be the effect of value-based cost reduction measures, especially for high-cost orthopaedic and spine surgeries”.
 
Each year in the US, >$90bn is spent on low-back pain alone and ~1.6m spinal surgeries are performed. The cost of a single-level spinal fusion in a less expensive region of the US is ~US$65,000 for Medicare or ~US$100,000 with private insurance. In more expensive areas, such as New York or Los Angeles, these costs can grow by 2 to 3 times. In remote regions, such as eastern Wyoming and Alaska, high costs of surgical procedures can be a function of the scarcity of specialist clinicians. Such high costs could be an incentive for physicians to perform surgery. Research supports this by suggesting that clinicians are more likely to recommend surgery, even though it is neither the optimum nor the only treatment option available.
 
7. Benign reimbursement policies
 
Historically, in the US, third-party payors have tended to reimburse spine surgery for LBP more than non-invasive therapies. Insurers have also tended to reimburse surgical services rather than patient outcomes, although this is changing. For decades, the overwhelming percentage of patients bore little responsibility for the cost of spine surgeries. However, a 2016 New York Times article  reported that reimbursement policies for spine surgery were beginning to change, and suggested that, “financial disincentives accomplished something that scientific evidence alone didn’t”. The Times article drew on findings of research published in the June 2016 edition of the journal Spine, which argued that, “spinal fusion rates continued to soar in the US until 2012, shortly afterwards Blue Cross of North Carolina said it would no longer pay”. It seems reasonable to assume that benign reimbursement policies helped to drive the increase in spine surgeries. However, following the Blue Cross decision other insurers followed, and US payors started to move away from a fee-for-service model towards  reimbursing “value”. This shift, which is expected to continue, has slowed the growth rate of common spine surgeries.
 
Takeaways
 
Over the past three decades, the escalating prevalence of LBP, the challenges of diagnosing the condition, rapidly ageing populations, rising incidence rates of obesity, high costs of spine surgeries, and benign reimbursement policies, have all contributed to what has become a global spinal implant and devices industry. Such conditions encouraged an ecosystem in which the incidence rates of spine surgeries have soared, while LBP has persisted in a significant percentage of patients following surgery. Although the spine market is beginning to transform itself by moving away from a fee-for-service model towards a value-based model, which aims at providing patients with the best outcomes at the lowest cost, do not underestimate the time it will take for this transformation to succeed. Indeed, it seems reasonable to suggest that, given the structure and nature of the industry, the paradox that this Commentary attempts to explain will persist, at least for the near to medium term.
 
Post Scriptum
 
Findings of a 2016 study in the peer reviewed Malaysian Orthopaedic Journal conclude that, “The spine, unfortunately, has been labelled as a profit centre and there are allegations of conflicts of interest in the relationship of doctors with the multi-billion-dollar spinal devices industry. The spine industry has a significant influence not only on research publications in peer review journals, but also on decisions made by doctors, which can have a detrimental effect on the welfare of the patient”.
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3 years, 6 months ago

Low back pain, spine surgery and market shifts

HealthPad
Directory:
Neurosurgery
Tags:
commentary
complex spine surgery
LBP
lower back pain
spine devices
spine fusion
  • Low back pain (LBP) and degenerative spinal disc disorders are leading age-related causes of disability throughout the world
  • Global populations continue to age, and incidence rates of LBP and degenerative disc disorders continue to increase
  • Surgery has become a common therapy for the conditions and their incidence rates have risen sharply over the past two decades
  • This has fuelled a global US$10bn spinal implant and devices market
  • Spine surgeries tend to be paid for by working age populations
  • In wealthy spine markets working age cohorts are shrinking
  • This suggests spending levels on spine surgery will be squeezed
  • The knock-on effects of this are likely to put pressure on spine companies to adapt their strategies and business models
 
Low back pain and the global spine industry

Low back pain, spine surgery and market shifts
 
Low back pain (LBP) is a common age-related health condition associated with degenerative spinal disorders, and recognised by the World Health Organisation (WHO) as one of the top ten global disease burdens. In most wealthy nations, low birth rates and relatively high life expectancy have resulted in the number of working age people shrinking and the number of retirees with sedentary lifestyles increasing. This has led to a high prevalence of LBP and age-related spinal disorders.
 
First-line clinical guidelines for LBP recommend non-surgical treatments and encourage physicians to be cautious about surgical solutions. Diagnosing LBP is challenging, and doctors constantly contend with treatment dilemmas. However, over the past three decades spine surgery has become a significant therapy for LBP.
 
A common procedure used to treat a range of degenerative disc disorders, which present as LBP, is spinal fusion. This is a neurosurgical or orthopaedic surgical technique to permanently connect two or more vertebrae in your spine so that they heal into a single, solid bone. The procedure can be performed at any level in the spine and prevents any movement between the fused vertebrae. The technique is designed to mimic the normal healing process of broken bones.
 
In this Commentary
 
This Commentary suggests that as global populations have aged, so the incidence rates of LBP and degenerative disc disorders have increased and become a leading cause of age-related disability throughout the world. Spine surgery has become a common therapy for the conditions. This has fuelled a global spinal implant and devices market. Spine surgeries tend to be paid for by working age populations, which are shrinking in the wealthy spine markets of the world. This suggests that spending levels on spine surgeries will be squeezed and this will put pressure on spine companies to transform their strategies and business models.
 
The global burden of LBP

A series of three research papers on LBP and its associated disabilities published in the March 2018 edition of The Lancet estimate that ~0.54bn people worldwide are living with LBP, which has risen by more than 50% since 1990, and is projected to increase even more as the world's population ages and as populations in lower- and middle-income countries move to urban centres and adopt more sedentary lifestyles.
 
The importance given to treating LBP is because of the significant burden it inflicts on individuals, healthcare systems and productivity. The Global Burden of Disease Study 2017 suggests that LBP accounts for some of the highest numbers of disability-adjusted life years (DALYs) worldwide [DALY is a measure of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death].
 
According to the UK’s 2014 NHS National Pathfinder Study, LBP is responsible for the loss of 2,313 DALYs per 100,000. This is a substantially higher ratio than the remainder of musculoskeletal conditions (911), depression (704) and diabetes (337) combined, and accounts for 11% of the overall disability burden from all diseases in the UK, where the burden of LBP is on the increase both in absolute (~3.7%) and proportionate (~7 to 8.5%) terms. The increased prevalence of LBP creates added demand and escalating costs for NHS England, estimated to be >£12.3bn (US$17bn) per year.
A 2012 study published in The Spine Journal suggests that LBP accounts for >3% of all visits to A&E in the US and estimates that each year, “>2m episodes of LBP occur among an at risk population of over 1.48bn person-years for an incidence rate of 1.39 per 1,000 person-years”. Findings of a 2016 study suggest that, “US adults with LBP are socioeconomically disadvantaged, make frequent healthcare visits and are often covered by government-sponsored health insurance”. The US Bureau of the Census estimates that, each year, LBP costs Americans ~US$50bn in healthcare costs. If you add in lost wages and decreased productivity, this figure easily rises to >US$100bn.

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Age of the aged and low back pain
LBP and degenerative spinal disorders

In the video below Ranj Bhangoo, a consultant neurosurgeon at King’s College Hospital, London explains how LBP and degenerative disc disorders are overwhelmingly the result of normal wear and tear, which occur over time as you grow older. Years of constant use and absorbing daily shocks take their toll, which suggests that, sometime during your lifetime, you will suffer from LBP. In most cases, it is not your spinal vertebrae that experience the effects of the wear and tear, but the 23 cartilage-based structures (discs), which sit between your vertebrae. These are filled with a jelly-like substance and act as shock absorbers, help to hold your vertebrae together and facilitate slight mobility in your spine. As you age, your discs lose their jelly-like substance, start to crack, and begin to naturally degenerate. This is believed to manifest itself as LBP, which can radiate down your leg and cause a condition called sciatica.
 
 
Spine surgery
 
If you are over 50, suffer from LBP, live in the US, Europe, or Japan, and have medical insurance, it is likely that during your lifetime you will have surgery to reduce your pain following a period of a non-surgical therapy. Scientific evidence supports surgery in a select group of patients who have failed to respond to non-operative treatments over a minimum of six months. However, a significant percentage of spine operations fail to relieve back pain and between 10% and 46% of primary spine procedures require revision surgeries.
 
In the video below, Ranj Bhangoo describes the care taken by clinicians not to rush into surgery for LBP.  When a patient presents with back pain, it is important to ask three questions: “Is the history of the pain compatible with a particular disc causing that pain? Does an examination suggest that a particular disc is causing the problem? Does a scan show that the disc you thought was the problem is the problem? If the answers ‘fit”, then there might be benefit in considering some treatment options, but not necessarily surgery. . . . . . Because 90% of us will get back pain at some point in our lives, 90% of us don’t need an operation”, says Bhangoo, whose opinion resonates with that of the Mayo Clinic: “Back surgery can help relieve some causes of back pain, but it’s rarely necessary,” and although “back pain is extremely common, surgery often fails to relieve it”.

 
 
 
Clinical dilemmas

Although first line clinical guidelines recommend non-surgical treatments for LBP and degenerative disc disorders and clinicians are cautious about possible treatment options, over the past three decades surgery has become a relatively common therapy for LBP and has fuelled a global spinal implant and devices market. The Lancet’s 2018 studies on LBP suggest that, “gaps between evidence and practice exist, with limited use of recommended first-line (non-surgical) treatments and inappropriately high use of surgery”.
 
However, the nature of evidence underpinning the use of non-surgical treatments for LBP does not help clinicians in their choice of therapies. A research paper, published in the March 2020 edition of the BMC Medical Journal, critically appraises the current evidence for non-surgical therapies for LBP and concludes that while, “pain management services may be cost effective for the management of low back pain the quality of evidence is variable”.
  
Spinal fusion

Spinal fusion is a common surgical therapy for a number of spinal disorders, some of which may present as LBP and include: (i) degenerative disc disease, which occurs when one or more of your discs between your vertebrae deteriorate and cause pain, (ii) spondylolisthesis, which occurs when one of your lower vertebrae slips forward onto the bone directly beneath it, (iii) spinal stenosis, a narrowing of the spaces within your spine, most often in your lower back and neck, which can put pressure on the nerves that travel through your spine, (iv) kyphosis, a spinal disorder in which an excessive outward curve of your spine results in an abnormal rounding of your upper back, and (v) scoliosis, which is a sideways curvature of your spine.
 
Despite being a common procedure, spinal fusion is a major surgery, which can be associated with significant morbidity and occasionally with mortality. In the video below Nick Thomas, a consultant neurosurgeon at King’s College Hospital, London, describes spinal fusion, which in certain circumstances, may be beneficial in improving pain.
 
 
Incidence rates of spinal fusion increasing

According to findings published in the March 2019 edition of the journal Spine, >2m spinal fusions were performed in the US in 2015. This represented an increase of 32% since 2004, with the largest increase (73%) among patients ≥65. Outcomes of spinal fusion procedures vary depending on the condition for which the surgery is performed. When performed for spinal deformities and spondylolisthesis, reported outcomes are generally favourable. However, the success rate of spinal fusion as a therapy for LBP and degenerative disc disorders is patchy.
 
Evolving techniques

Given these uncertainties, emphasis has been given to several evolving techniques such as interbody fusion and lumbar disc arthroplasty, which are more complex, technically demanding, and higher risk types of fusion. The former procedure involves removing your intervertebral disc and joining two or more vertebrae together using screws and interbody spine cages. These are hollow threaded cylindrical implants commonly constructed of polyetheretherketone (PEEK) and titanium, which have desirable biocompatibility and mechanical properties. Cages are filled with bone graft, and eventually become part of your spine.


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The latter procedure replaces a damaged spinal disc with an artificial one designed to support your vertebrae while preserving motion. These, and other hybrid techniques, are still relatively novel procedures despite promising near-term outcomes. Long-term studies demonstrating their superiority over traditional spinal fusion are required before they may be recommended to replace traditional fusion as the gold standard.

Further, recent scientific advances have allowed clinicians to explore innovative stem cell therapies in spinal fusion procedures in attempts to reduce morbidity and compensate for the limitations of autografts. However, results of research have not yet been translated into common practices to treat patients.
The incidence rates of spine surgery in the US

The US has the highest rate of spine surgeries in the world. In the 1980s rates increased by 55%. In the 1990s studies of spine surgery rates became more challenging because >20% of common spine procedures shifted to out-patient settings. Extrapolations from ambulatory surgical data suggest that throughout the 1990s, spine surgery rates continued to rise. The most rapid increase was for spinal fusion, which tripled during the decade and accounted for an increasing proportion of all spine procedures.
 
Since the 1990s, numerous studies have described the continued growth of spine surgery in the US, where today ~1.6m spine procedures are performed annually. Between 2004 and 2015, the volume of spinal fusions increased by 62%. During this 12-year period, aggregate hospital costs increased 177%, exceeding US$10bn in 2015 and averaging >US$50,000 per admission. A 1994 international comparative study found that, “the rate of back surgery in the US was at least 40% higher than in any other country and was more than five times that in England. Back surgery rates increased almost linearly with the per capita supply of orthopaedic and neurosurgeons in the country”.
 
The spinal implant and devices market

Over the past four decades, the high and increasing prevalence of spine surgeries has contributed to a high margin, profitable, global spinal implant and devices industry, comprised of ~400 companies but dominated by just four large American corporations: Medtronic, DePuy Synthes (Johnson & Johnson), NuVasive  and Stryker. These four control ~70% of the market, which in 2019 was valued at ~US$10.3bn, projected to grow at a compound annual growth rate (CAGR) of ~5%, and reach ~US$14bn by 2025. The US market segment alone was valued in 2020 at ~US$7.5bn, growing at a CAGR of 5.3% and expected to reach ~US10bn by 2025.
 
These spine market numbers include revenue from implants, instruments, and surgical assistance systems (robotics and navigation) to treat a variety of conditions. The industry has benefitted from advances in spine surgery technologies, the launch of novel bone grafting products and the increasing adoption of minimally invasive spine surgery (MISS). However, spinal fusion devices are the second largest segment of spine products behind plates and screws.
 
As a possible consequence of the industry’s rapid growth and relatively high margins, many spine companies have come to rely on linear supply chains and developed “cosy labour-intensive relationships” between producers, clinicians, hospitals, and payors. However, the high cost of spine surgery, tightening regulations and more stringent reimbursement policies threaten this business model.
 
Good news for spine companies

We know that age-related LBP and degenerative spinal disorders are significantly correlated to the incidence rates of spine surgery. The good news for the spine market is that, “virtually every country in the world is experiencing growth in the number and proportion of older persons in their populations”, and global life expectancy is rising and is expected to reach 77 years by 2050, up from 70 in 2015. The number of people ≥65, who account for most incidence of spine surgeries, is expected to increase by >60% in the next decade, from just >0.6bn in 2015 to ~1bn by 2030. A study published in the March 2020 edition of the Journal of the American Medical Association (JAMA) suggests that between 1996 and 2016, Americans spent ~US$134bn on therapies for back pain, which is more than that spent on the combined treatments for diabetes and heart disease.
 
Bad news for spine companies
 
Working age populations in the US and other spine markets ‘pay’ for the surgeries of the large and growing cohorts of retirees with sedentary lifestyles and LBP. However, working aged populations in these regions are declining because of falling fertility rates and professional women delaying motherhood. This suggests, ceteris paribus, that for the foreseeable future, a shrinking pool of working-age people will be forced to support expensive spine surgeries for a vast and rapidly expanding cohort of aging retirees.  Thus, it seems reasonable to suggest that the current trajectory of spending on spine surgeries in the major spine markets of the world is unsustainable, and increasingly, likely to exert downward fiscal pressure on spine companies.
 
Changing ecosystem

Such demographic trends are already exerting pressure on the spine market to deliver enhanced clinical outcomes at lower costs. For example, US reimbursement policies have moved away from a fee-for-service model towards a value-based model, which aims to utilize resources more efficiently by shifting the costs of over-treatment, revision surgeries and adverse clinical outcomes from payors to providers. Similar shifts are taking place in Europe and Japan. For example, in Europe fiscal pressure on healthcare systems has meant rationing and/or delaying elective spine surgeries. In Japan, more spine surgery costs are being shifted to employers and patients.
 
Population effectiveness

In wealthy spine markets decisions that used to be the sole preserve of doctors are increasingly being made by regulators, hospital administrators and other non-clinicians. This broader set of influencers have different objectives to doctors and prioritize cost effectiveness or even just costs. This is fuelling a shift away from individual patient outcomes towards a focus on the cost effectiveness of specific spine procedures on a given population. For example, the overall improvement within a cohort of patients ≥65 with LBP and degenerative disc disorders and a given level of spending by a hospital group on spinal fusions.
 
Innovations increasing in significance
 
Such shifts have encouraged innovations, which enhance outcomes and are positioned to change the standard of spine care. These include, minimally invasive spine surgery (MISS), robotics, computer assisted navigation, motion preserving technologies, and ortho-biologics, which will be discussed in future Commentaries. For now, let us finish by suggesting that such innovations could erode the competitiveness of traditional spine companies that are slow to change, and enhance the competitiveness of companies with the mindset, resources, and capabilities to invest in these evolving technologies.
 
Takeaways

Fiscal, technological, and demographic trends are driving the demand for competitively priced spinal implants and devices. Cost conscious US hospitals have consolidated to increase their buying power. Purchasing has become more centralized as hospital groups have leveraged their scale by standardizing processes and procedures across facilities. Providers have sharpened their focus on the cost effectiveness of spinal implants and devices and engaged in M&A activities to enhance their scale, R&D, and marketing. This has expanded the range of product offerings a single company supplies, but also it has increased market concentration, which advantages a few large dominant companies. The effect of these trends has yet to transform the strategies and business models of the overwhelming majority of traditional medium to small size spine companies, which will be needed for them to remain relevant in the future.
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3 years, 7 months ago

Ramadan Mubarak

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May the Rahmat of Almighty Allah shine upon you and your family always!

Welcome to the month of Ramadan with a heart filled with peace, harmony and joy.

May the divine blessings of Allah protect and guide you.

Sending best wishes to you from the HealthPad Team on this Holy occasion.
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3 years, 11 months ago

Season's Greetings from the HealthPad Team

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PEACE, HEALTH AND BEST WISHES FOR 2021
from the HealthPad Team

 

2020 has undeniably been a challenging year. A pandemic has led the world to a global crisis, claiming the lives of many and disrupting so many others with the consequences it brought.

But the impact of CoVid-19 managed to inspire a renewed sense of community and showed the potential of what can be achieved when we work together and support each other.

The HealthPad Team wishes for this spirit to endure in 2021. May you and your loved ones stay safe and well, have a Happy Holiday season and a peaceful and prosperous New Year.

Thank you for your continued support throughout 2020, we look forward to another year together!
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4 years, 1 month ago

E-skin set to disrupt healthcare

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  • The ‘needle’ has moved significantly since the FDA approved the first artificial human skin in 1996
  • Researchers in Australia have developed an electronic artificial skin (e-skin) that reacts to pain just like real skin 
  • Researchers in the US have developed an e-skin that mimics the functions and properties of human skin
  • These are just 2 examples of 100s of e-skin developments currently taking place around the world
  • Research findings on the functions and properties of e-skin pave the way for enhancing non-invasive alternatives to skin grafts, improving consumer healthcare, developing smarter prosthetics and advancing intelligent robotics
  • Such improvements are likely to take place over the next decade
  • One possible near-term application for e-skin is to enhance the Apple Watch
  • The commercial beneficiaries of e-skin are more likely to be giant tech companies rather than traditional manufacturers of medical devices
  
E-skin set to disrupt healthcare
 
 
In September 2020 researchers from Australia’s Royal Melbourne Institute of Technology (RMIT) published findings of a study entitled, “Artificial Somatosensors: Feedback Receptors for Electronic Skins” in Advanced Intelligent Systems. The study’s focus was an electronic artificial skin (e-skin) made of silicone rubber with integrated electronics with the capacity to mimic the functionality of real skin and almost instantaneously distinguish between less and more severe forms of pain. Just as nerve signals instantaneously travel to your brain to inform you that you have encountered something sharp or hot, the e-skin reported in this study triggers similar mechanisms to achieve comparable results. This represents a significant advance towards the next generation of biomedical technologies, non-invasive skin grafts, smart prosthetics and intelligent robotics: all large, underserved fast growing global markets.
 
A significant advance in bioengineering

According to Madhu Bhaskaran, the study’s lead author, a professor at RMIT and the co-leader of the University’s Functional Materials and Microsystems Research Group, the research is the first time that electronic technologies have been shown to mimic the human feeling of pain. “No electronic technologies have been able to realistically mimic that very human feeling of pain - until now. It’s a critical step forward in the future development of the sophisticated feedback systems that we need to deliver truly smart prosthetics and intelligent robotics,” said Bhakaran.
 
Her remarks were emphasised by Md Ataur Rahman, a researcher at RMIT who said, “We’ve essentially created the first electronic somatosensors - replicating the key features of the body’s complex system of neurons, neural pathways and receptors that drive our perception of sensory stimuli . . . . While some existing technologies have used electrical signals to mimic different levels of pain, our new devices can react to real mechanical pressure, temperature and pain and deliver the right electronic response . . . .  It means our artificial skin knows the difference between gently touching a pin with your finger or accidentally stabbing yourself with it - a critical distinction that has never been achieved before electronically.”
 
Combination of three smart technologies

The RMIT device combines three ”game-changing” technologies to deliver its superior sensing capabilities, all previously designed and patented by Bhakaran’s team. The first is a stretchable, transparent and unbreakable electronic device made of oxide materials and biocompatible silicone, which allows it to be as thin as a piece of paper. The second is a temperature-reactive coating that is, “1,000 times thinner than a human hair”, which can transform when it comes into contact with heat. The third is a “brain-mimicking memory”, which facilitates electronic cells to simulate your brain’s ability to remember temperature and pain thresholds and store these in its own long-term memory bank. Further development is required to integrate these technologies into biomedical applications and demonstrate their stability over time, but crucially says Bhaskaran, “the fundamentals - biocompatibility, skin-like stretchability - are already there."
 
E-skin research has been progressing for decades

E-skin research is not new and has been developing for at least the past three decades. Here we cannot do justice to the breadth and depth of such research, but we can give a flavour of its history and briefly describe another e-skin that mimics human skin, which was reported in the February 2018 edition of Science Advances.
 
As early as the 1970s, researchers were exploring the potential application of tactile‐sensing simulation and had demonstrated certain touch sensors, but with low resolution and rigid materials. Notwithstanding, over the ensuing two decades significant breakthroughs were achieved in malleable and stretchable electronic devices for various applications. More recently, tactile sensors with enhanced performance have been developed based on different physical transduction mechanisms, including those affecting: (i) the change in the electrical resistivity of a semiconductor or metal when mechanical strain is applied (piezoresistivity), (ii) the ratio of the change in electric charge of a system to the corresponding change in its electric potential (capacitance), and (iii) the electric charge that accumulates in certain solid materials in response to applied mechanical stress (piezoelectricity). Parallel to these advances, significant progress also has been made in design, manufacturing, electronics, materials, computing, communication and systems integration. Together, these developments and technologies open new areas for applications of bioengineered systems.
 
Breakthrough e-skin by a US group

The 2018 e-skin research study reported in Science Advances was led by Jianliang Xiao, a Professor of Mechanics of Materials and Wei Zhang, a Professor of Chemistry, both from the University of Colorado Boulder. They describe the characteristics of their e-skin, as “thin, translucent, malleable and self-healing and mimics the functions and properties of human skin.” Reportedly the e-skin has several distinctive properties, including a novel type of molecular bond, known as polyamine, that involves the sharing of electron pairs between atoms, which the researchers have embedded with silver nanoparticles to provide enhanced mechanical strength, chemical stability and electrical conductivity. “What is unique here is that the chemical bonding of polyamine we use allows the e-skin to be both self-healing and fully recyclable at room temperature,” said Xiao. Further, the e-skin’s malleability enables it to permanently conform to complex, curved surfaces without introducing excessive interfacial stresses, which could be significant for its development. The Boulder group has created a number of different types and sizes of their wearable e-skin, which are now being tested in laboratories around the world.
 
In the Commentary

In this Commentary we not only report the research findings of the two e-skin studies mentioned above, but we also describe, in simple terms, how you experience pain to illustrate the achievement of the Australian researchers from RMIT. We then describe human skin, its capacity to be wounded and traditional skin graft therapies to deal with such wounds. We briefly reference the invention of the first artificial human skin to receive FDA approval and highlight some of the massive and significant technological and market changes that have taken place since then. We conclude by suggesting that, over the next decade as e-skin technologies are enhanced, their potential healthcare applications are more likely to be owned and controlled by giant tech companies than traditional manufacturers of medical devices. More about this later. In the meantime, let us return to Bhakaran’s new pain-sensing e-skin and briefly describe the devilishly complex functionality of how you experience pain.
The function of pain and how you experience it
 
Your skin constantly senses things and your sensitivity to pain helps in both your survival and your protection. Pain prompts reflex reactions that prevent damage to tissue, such as quickly pulling your hand away from something when you feel pain. Notwithstanding, your pain response only begins when a certain threshold is breached. For example, you do not notice pain when you pick up something at a comfortable temperature, but you do when you prick your finger or touch something too hot. Consider this brief, over-simplified, description of how you experience pain.


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When you prick your finger on something sharp it causes tissue damage, which is registered by microscopic pain receptors in your skin. These send electrical signals through your nerve fibres that are bundled together with others to form a peripheral nerve. These electrical signals pass up your peripheral nerve and spinal cord to your neck area. Here they are transferred from one nerve cell to another by means of chemical messengers. The signals are then passed to three areas of your brain: one, the somatosensory cortex, that deals with physical sensation, another, the frontal cortex, which is linked with your thinking and a third area, your limbic system, which is associated with your emotions. All this occurs in nano seconds and results in you instantaneously feeling pain, wincing and becoming irritated when a pin pricks your finger.
 
Human skin and traditional skin grafts

Skin is your body’s largest and most versatile organ, which is unlike any other, not least because you wear it on the outside of your body. Not only is your skin a huge sensor packed with nerves for keeping your brain in touch with the outside world, it provides you with free movement. Adults carry  between 1.5 and 2.0 square metres of skin on their bodies, which weighs about 3.5kgs (≈16% of your body weight). Your skin is a “smart”, multifunctional organ that not only serves as a protective shield against heat, light, injury and infection, but also it is a sensory organ that regulates body temperature, stores water and fat, prevents water loss and helps to produce vitamin D when exposed to the sun. Skin wounds are relatively common and can be caused by trauma, skin diseases, burns or removal of skin during surgery. In the US alone, each year some 35m cases require clinical intervention for major skin loss.Your skin has three layers. The thin, outer layer that is visible to the eye is called the epidermis and the deeper two layers are called the dermis and hypodermis. Due to the presence of stem cells, a wound to your epidermis is able to stimulate self-regeneration. However, in cases of deeper injuries and burns, the process of healing is less efficacious and leads to chronic wounds. Any loss of full-thickness skin more than 4cm diameter needs to be treated immediately. Traditional ways of dealing with significant losses of skin have been skin grafts. The most common is to use either your own shin (autograft) or the skin from another person (allograft). Skin  grafts can also be obtained from a non-human source, usually a pig (xenograft). Autographs suffer from the fact that you may not have enough undamaged skin to treat the severity of your injury. Allografts and xenografts suffer from the possibility of rejection or infection. These challenges drove a need to develop an artificial skin.
 
The first FDA approved artificial human skin

The first artificial human skin to receive FDA approval was invented in the late-1970s by John Burke, a Professor of Surgery at the Harvard University Medical School and Chief of Trauma Services at Massachusetts General Hospital and Ioannis Yannas, a Professor of Polymer Science and Engineering at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. Burke had treated many burn victims and realized the need for a human skin replacement. Yannas had been studying collagen, a protein found in human skin. In the mid-1970s the two professors teamed-up to develop a material - an amalgam of plastics, cow tissue and shark cartilage - that became the first commercially reproducible, artificial human skin with properties to resist infection and rejection, protect against dehydration and significantly reduce scarring. In 1979 Burke and Yannas used their artificial skin on a woman patient, whose burns covered over half her body. In the early 1990s the Burke-Yannas skin was acquired by Integra LifeSciences Corporation. In March 1996 the company received FDA approval for it to be used on seriously burned patients, and Integra Artificial Skin became the first tissue regeneration product to reach the market. Since then, it has been used in therapies throughout the world and has saved and enhanced the lives of innumerable severely burned people. More recently, the Integra Artificial Skin has also been used in a number of other indications.
 
Technological advances and market changes since the first artificial skin

Since Integra’s launch of the first FDA approved artificial human skin, healthcare markets and technolgies have changed radically. In the mid-1970s when Professors Burke and Yannas came together to develop their artificial skin, Apple and Microsoft, two giant tech companies with interests in healthcare, were relatively small start-ups, respectively founded in 1976 and 1975.  it would be more than another  decade before Tim Berners-Lee invented the World Wide Web (1989), and then another decade before the internet became mainstream. The tech giants, Amazon and Google, also with interests in healthcare, were not founded until some years after that: 1994 and 1998 respectively. Over the past four decades substantial progress has been made in tissue engineered skin substitutes made from both artificial and natural materials by employing advances in various fields such as polymer engineering, bioengineering, stem cell research, nanomedicine and 3D bioprinting. Notwithstanding, a full thickness bioengineered skin substitute with hair follicles and sweat glands, which can vascularize rapidly is still not available. 
 
Market changes, e-skin, the Apple Watch and giant tech companies

In closing, we briefly focus on one potential near-term application for e-skin - to enhance the capabilities of the Apple Watch.  We do this to emphasise the significant market shifts, which are occurring in healthcare and the large and growing impact that giant tech companies are having on the sector.

The Apple Watch was first released in April 2015 by Tim Cook, Apple’s CEO, as a fashion accessory. Notwithstanding, its focus quickly shifted and within three years it had become a FDA approved medical device. The watch, not only can detect falls, but it also has 3 heart monitoring capabilities: one recognises and sounds an alarm when your heart rate is low, a second detects irregular heart rhythms and a third is a personal electrocardiogram (ECG), which is a medical test that detects heart problems by measuring the electrical activity generated by your heart as it contracts. According to Strategy Analytics, a consumer research firm, in 2019, an estimated 30.7m Apple Watches were sold worldwide; 36% higher than the 22.5m watches Apple sold in 2018.

In 2020, during the coronavirus public health emergency, the FDA expanded its guidance for non-invasive patient-monitoring technologies, including the Apple Watch’s ECG function. This expanded use is intended to help facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to CoVID-19.
 
Currently, the Apple Watch is worn like any other watch and if it is loose, its data harvesting capacity could be compromised. In the form of a watch, e-skin would conformally adhere to irregularly shaped surfaces like your wrist. The two e-skins described in this Commentary; both with intrinsic stretchability could potentially facilitate the Apple Watch to be more integrated with the wearers own skin.

The unstoppable march of giant tech companies into healthcare
 
Today, not only do giant tech companies such as Apple, Amazon, Google and Microsoft have their global market presence as a significant comparative advantage to enter and expand into healthcare, but they also have unparalleled data management capabilities. Since the invention of artificial skin by Burke and Yannas healthcare has become digital and global. Because giant tech companies’ have superior access to individuals’ data and state-of-the-art data handling capabilities; they know customers/patients significantly better than any healthcare provider. This, together with their global reach, positions giant tech companies to provide discerning patients with the healthcare solutions they need and increasingly demand.
 
IBM Watson Health estimates that by the end of 2020, the amount of medical data we generate will double every 73 days. According to Statistica, an analytical software platform, new healthcare data generated in 2020 are projected to be 2,314 exabytes. Traditional healthcare providers cannot keep up with this vast and rapidly growing amount of health information, despite the fact that such information is increasingly significant as healthcare shifts away from its traditional focus on activity and becomes more outcomes/solutions orientated. Giant tech companies are on the cusp of meeting a large and growing need to understand, structure and manage health data to build a new infrastructure for the future of healthcare.
 
Takeaways

The potential impact of e-skin is significantly broader than enhancing the Apple Watch. The research findings reported in this Commentary suggest that e-skin is well positioned to disrupt substantial segments of healthcare over the next decade. Findings published in Advanced Intelligent Systems and Science Advances suggest that one potential application is for e-skin to be seamlessly integrated with human skin. This not only positions it to become the next generation for a number of traditional MedTech applications, such as non-invasive skin grafts, but also to deliver a step change in the consumer health market by producing breakthroughs in human-machine interfaces, health monitoring, transdermal drug delivery, soft robotics, prosthetics and health monitoring. If traditional manufacturers are to benefit from e-skin they will need to adapt and transform their processes because the natural fit for e-skin technologies is industry 4.0, [also referred to as smart manufacturing and the Internet of Things (IoT)], which is expected to become more pervasive over the next decade as developments of e-skin unfold. Industry 4.0 combines physical production and operations with smart digital technology, machine learning and big data to create more solution orientated healthcare ecosystems and thereby tends to favour the giant tech companies and their growing healthcare interests.
 
#e-skin #artificialskin #AppleWatch 
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4 years, 1 month ago

Changing the code of life

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Changing the code of life



Congratulations!
 
On 7 October,  the Royal Swedish Academy of Sciences announced that it had awarded the 2020 Nobel Prize for Chemistry to two women scientists: Emmanuelle Charpentier (L), a French microbiologist, geneticist and biochemist,  who is now the director of the Max Planck Unit for the Science of Pathogens in Berlin, Germany, and Jennifer Doudna (R), an American biochemist  who is a professor of chemistry, biochemistry and molecular biology at UC Berkeley.

The scientists developed a simple, cheap, yet powerful, and precise technique for editing DNA, which is called CRISPR-Cas9 (an acronym for Clustered Regularly Interspaced Short Palindromic Repeats) and popularly referred to as a pair of ‘genetic-scissors’. The technology endows science and scientists with extraordinary powers to manipulate genes to cure genetic diseases, improve crops to withstand drought, mould and pests, and affect climate change, and is considered to be the most important discovery in the history of biology. The Nobel citation refers to Charpentier’s and Doudna’s scientific contribution as a, “tool for rewriting the code of life”, which has “a revolutionary impact on the life sciences, by contributing to new cancer therapies and may make the dream of curing inherited diseases come true”.

For more than four years HealthPad has been following and publishing Commentaries on the scientists’ work. Our Commentaries have a large and growing global following of leading physicians, scientists, policy makers, journalists and students. The Commentaries listed below about CRISPR techniques, which we re-publish to celebrate Charpentier’s and Doudna’s Nobel Prize, have had more than 120,000 views.
 
Gene editing positioned to revolutionise medicine
1 Feb 2017
 
Gene editing battles
15 Mar 2017
 
Who should lead MedTech?
18 Jul 18
Base-editing next-generation genome editor with delivery challenges
17 oct 2018
CRISPR-Cas9 genome editing a 2-edged sword
31 Oct 2018
Will China become a world leader in health life sciences and usurp the US?
27 Feb 2019
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4 years, 2 months ago

Narcissism and a second more devastating wave of CoVID-19

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Medicine
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commentary
coronavirus
coVID-19 pandemic
narcissism
  • The CoVID-19 pandemic has been controlled by government policies that restrict individual behaviour 
  • Even if the accelerated vaccine development goes to plan and is successful, government restrictions will be necessary for some time yet 
  • Recent research suggests that, at the height of the CoVID-19 pandemic, people with narcissistic and other “dark” personality traits flouted public health restrictions  
  • Research has also shown that the coronavirus can be spread by a relatively small group of individuals who break public health protocols 
  • Could a small group of asymptomatically infected individuals with narcissistic traits trigger a renewed and significantly more devastating outbreak of CoVID-19?
  
Narcissism and a second more devastating wave of CoVID-19
 
 
Research suggests that in early 2020, at the height of the CoVID-19 pandemic, people with narcissistic and other “dark” personality traits, (Machiavellianism and psychopathy) flouted public health restrictions, such as social distancing, stay-at-home measures, mask-wearing and hand washing, introduced to prevent the spread of the coronavirus.
 
The fastest and deepest global economic shock in history

The outbreak of CoVID-19 in December 2019 started an epidemic of acute respiratory syndrome in humans in Wuhan, China, which quickly became a pandemic responsible for the fastest and deepest global economic shock in history. In a matter of weeks, stock markets collapsed, credit markets froze, huge bankruptcies occurred, unemployment rose above 10% and annual GDP rates contracted by 8% or more. In the absence of either a vaccine or a therapy, the social and behavioural sciences were used by governments to help align human behaviour with the recommendations of epidemiologists and public health experts to reduce the impact of the coronavirus outbreak. 
 
Measures were successful and as nations regained control of the virus’s transmission and reduced the burden on their healthcare systems, restrictions were relaxed or removed to re-energise damaged economies and encourage more viable lifestyles with the virus still in circulation. In many countries, this increased the incidence levels of CoVID-19, hospitalisations and deaths; and governments had no alternative but to re-instate selected restrictions on people’s behaviours.
 
Now, some ten months after the initial outbreak, governments throughout the world are bracing themselves in the knowledge that a relatively small group of people who flout restrictions could cause the coronavirus to return, which some analysts suggest could be more devastating than the impact of its initial outbreak. This is because healthcare systems have been significantly weakened and are struggling to cope with huge backlogs of patients whose treatments have been delayed because of the coronavirus, economies have been damaged, and the annual winter flu epidemic is expected in most Western developed nations.
 
In this Commentary

This Commentary describes the findings of three recent studies, which examine the relationships between the Dark Triad traits (i.e., narcissism, Machiavellianism and psychopathy) and behaviours related to the COVID-19 pandemic. Findings suggest that, at the height of the pandemic in March and April 2020, people with narcissistic and psychopathic personality traits were more likely to ignore rules, such as hand washing, social distancing, staying-at-home and mask-wearing and therefore could have become super spreaders of the disease. The Commentary focusses on narcissistic traits. We begin by underlining some of the challenges of developing and manufacturing a CoVID-19 vaccine at scale, which is safe and effective. We then describe Narcissistic Personality Disorder (NPD) and the R number, which governments have used to explain how well the virus is being controlled. We also describe the lesser known K metric, which is critical to epidemiologists’ attempts at understanding how CoVID-19 is actually transmitted. We then briefly describe the concepts of super spreaders and super-spreading events, which help to explain how a relatively small group of people can have a significant impact on the transmission of the coronavirus. Brief descriptions of the findings of three recent research studies follow. These suggest that people with narcissistic and other “dark” personality traits, break public health restrictions. Finally, we draw attention to the limitations of the studies and provide some “takeaways”.
 
Developing and scaling vaccines is challenging

Although scientists look likely to produce a CoVID-19 vaccine much faster than anyone could have predicted, and governments have pre-purchased about 4bn doses of these for delivery at the end of 2020, developing a safe and effective vaccine at scale is challenging. The failure rate of vaccines that reach advanced clinical trials is as high as 80%. Some CoVID-19 vaccines in production that receive regulatory approval might only provide partial or temporary protection, others might require more than one dose to be effective. So, even if the accelerated vaccine development goes to plan and is successful, it is not altogether clear whether this would secure protection for enough people throughout the world to halt the spread of the virus in the medium term. Thus, it seems reasonable to assume that, behavioural techniques to slow or stop the spread of the coronavirus will be needed for some time yet, and people with narcissistic personality traits could reduce the effectiveness of these endeavours.
 
Narcissistic Personality Disorder

Narcissism is a pattern of grandiosity, a need for admiration and a lack of empathy. The condition has its genesis  in Greek mythology, and a beautiful and proud young man called Narcissus, the son of the river god Cephissus and the nymph Liriope. Many fell in love with Narcissus, but he only showed them disdain and contempt. When Nemesis, the goddess of retribution and revenge, learned of this she decided to punish Narcissus for his behaviour and led him to a pool where he saw his reflection in the water and fell in love with it. Narcissistic personality disorder (NPD) is rare. Although the term NPD has been used since 1968, only in 1980 was it officially recognized in the third edition of the Diagnostic and Statistical Manual of Mental Disorders, which is a taxonomic and diagnostic manual published by the American Psychiatric Association. Notwithstanding, in all probability we all know someone with narcissistic tendencies, which we often dismiss as just a “big ego” problem. And, if we are honest, at some point in our lives, we have demonstrated some narcissistic traits. The signs and symptoms of NPD include: (i) having an exaggerated sense of self-importance and a sense of entitlement, (ii) wanting constant, excessive admiration, (iii) expecting to be recognized as superior even without achievements that warrant it, (iv) exaggerating achievements and talents, (v) believing that you are superior and desiring to associate with equally ‘special’ people, (vi) having an inability or unwillingness to  recognize the needs and feelings of others, (vii) expecting special favours and unquestioning compliance, and (viii) taking advantage of others to get what you want. Although research in social and personality psychology has added significantly to our general understanding of narcissism, it has been one of the least studied personality disorders, mainly because of its low societal urgency and health costs. The causes of NPD are unknown, and the condition remains a controversial diagnosis. Some researchers think that overprotective or neglectful parenting styles may have an impact. Genetics and neurobiology also may play a role in the development of NPD. Given the challenges of diagnosing the condition, prevalence rates vary significantly. For instance, in the US, reported prevalence in the general population varies from 0.5% to 5%. NPD is less frequently identified in psychiatric settings, but more often seen in private clinical settings and applied to higher-functioning patients.
 
R number

In early 2020, during the height of the coronavirus crisis, politicians throughout the world and public health officials constantly referred to the R or R0 number to indicate the spread of the virus. As a consequence, most people now know that R refers to the average number of people one person with coronavirus is likely to infect. R is calculated through a combination of data and modelling, which includes hospital and intensive care admissions, people testing positive, deaths and surveys of people’s contacts. R indicates whether the number of infected people is increasing or decreasing. When R is above 1, the virus will grow exponentially in a population with no immunity. At 1, the disease remains steady. Below 1, the virus will gradually infect fewer people, until the epidemic dries up. However, in real life, some people with the disease infect many others, while others with the coronavirus do not spread the disease at all. This means that the R number hides significant differences between individuals and their impact on virus transmission.
K number

To compensate for this, epidemiologists use an additional metric referred to as K, which describes the pattern of CoVID-19 transmission. K is the statistical value, which indicates  the variability in the number of new coronavirus cases that each person has infected. A high K value (>5), tells us that most people are generating similar numbers of secondary cases. A low value for K (>1)  tells us that a small number of infected people can trigger significant numbers of new cases relatively quickly.
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Key to controlling CoVID-19

Epidemiologists believe the K number, or the role played by variable transmission of the coronavirus, is critical to controlling its spread. Notwithstanding, what makes controlling the transmission of the coronavirus more challenging is the fact that many highly infectious people are asymptomatic. According to research findings of a paper published in the June 2020 edition of The Annals of Internal Medicine, 40% to 45% of those infected by CoVID-19 display no signs or symptoms of the disease at all, which suggests that, “the virus might have a greater potential than previously estimated to spread silently and deeply through human populations”. Thus, understanding why and how the virus is transmitted is key to gaining control of the CoVID-19 pandemic and stopping a second wave of cases.
 
Super-spreaders

As we have suggested, there is wide variability in the behaviours of infected individuals and their subsequent roles in spreading the coronavirus. A paper published in the June 2020 edition of Wellcome Open Research analysed the spread of CoVID-19 from China and estimated the K value to be as low as 0.1.  This suggested that 80% of new coronavirus cases were caused by only about 10% of infected individuals. An infected individual who breaks the rules is likely to generate significantly more secondary cases that an infected person who does not broach public health protocols. The Wellcome paper demonstrates how a relatively small number of infected people who flout government guidelines could become ‘super-spreaders’ and cause CoVID-19 to quickly rebound, even if locally eradicated. Thus, identifying and tracking super-spreaders, is fundamental to preventing future outbreaks.
 
Super spreading events

Super spreaders are responsible for super spreading events, which are not well understood and are challenging to study. Although there is no universally agreed definition of a super spreading event, it is generally assumed to be an incident in which someone passes on the virus to six or more people. Examples of super-spreading events of CoVID-19 include outbreaks in Seoul nightclubs in South Korea,  meat packing plants in the US and overcrowded clothes factories in the UK.
 
Three studies

We now turn to the findings of three recent research studies, which suggest that some super-spreaders of CoVID-19 might be people with specific personality traits. The first study we describe is entitled, “Adaptive and Dark Personality Traits in the Covid-19 Pandemic”. It is published in the June 2020 edition of the Journal of Social Psychological and Personality Science and was carried out by Pavel Blagov, who is the director of the Personality Laboratory at Whitman College, USA. The second and third studies are Polish and both published in the July 2020 edition of  Journal of the International Society for the Study of Individual Differences. One is entitled “Adaptive and maladaptive behavior during the COVID-19 pandemic”, and was conducted by researchers from SWPS University of Social Sciences and Humanities, Poland. The third study is entitled, “Who complies with the restrictions to reduce the spread of COVID-19?”, which was carried out by researchers from the University of Warsaw.
 
The Whitman College Study

In late March 2020, Blagov surveyed 502 American adults, to assess their personalities and gauge how compliant they were with public health protocols for reducing the impact of CoVID-19 such as; social distancing, wearing protective gear or following basic hygiene rules. While the majority of participants reported adherence to public health restrictions, some did not. The  study found that individuals with the so-called "Dark Triad" personality traits (narcissism, Machiavellianism and psychopathy) were more likely to purposely disregard protocols intended to reduce the spread of the coronavirus. The respondents who showed disinterest in the recommended health procedures scored higher on sub-traits of meanness and disinhibition. According to Blagov, it is possible that rule breakers become super-spreaders of CoVID-19 and “have a disproportionate impact on the pandemic by failing to protect themselves and others”.  

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At the height of the pandemic, narcissists and others with dark personality traits tended to act contrary to public health recommendations. They showed less inhibition to risk and disregarded other people's safety; manifestations of which included, not covering themselves when sneezing or coughing in public, touching communal facilities, not staying at home, not keeping their distance from others and not washing their hands frequently. The  study concludes that, “there may be a minority of people with particular personality styles (on the narcissism and psychopathy spectrum) that have a disproportionate impact on the pandemic by failing to protect themselves and others.”
The  SWPS Study

These findings are supported by the  SWPS study, which is based on an online survey of 755 people (332 male and 423 female) between 15th and 29th March 2020, which was during the first month of the national CoVID-19 lockdown in Poland. The cohort was middle class with ages ranging from 18 to 78, (M = 45.83, SD = 14.98). Over 40% of the participants had either a high school or a university education.  Findings suggest that people with narcissistic or psychopathic tendencies were more likely to hoard essentials during lockdown mainly because they had a heightened sense of entitlement, which manifested itself in being greedier and more competitive.

Also, researchers suggest that participants with narcissistic personalities tend to be self-centred and lack empathy, and therefore more likely to exploit other people. People with psychopathic tendencies may be more cruel, deceitful and manipulative while coming across superficially charming.  According to Bartłomiej Nowak, the lead author of the study, narcissists are: (i) more impulsive, (ii) focused on self-interest, (iii) tend toward risk-taking and (iv) less likely to comply with measures to reduce the spread of the coronavirus.
 
The Warsaw Study

The Warsaw study set out to use the CoVID-19 pandemic to understand who complies with public health restrictions  to reduce the spread of the coronavirus. Researchers hypothesised that narcissistic and psychopathic personality traits of rivalry and lack of empathy may be associated with less compliance towards government imposed coronavirus restrictions. The study was based on an online survey carried out between 14th and 30th April 2020, which was at the height of the coronavirus crisis in Europe. There were 263 participants (27.8% male, 71.5% female, 0.8% “other”) aged between 18 and 80  (M = 28.96, SD = 10.64) and about half (49%) had a university education. 
 
The study’s findings support those of the previous two studies described above. Researchers found that compliance with public health guidelines to control CoVID-19 was low among participants who had narcissistic tendencies. Participants scoring low on agreeableness and high on aspects of narcissism and psychopathy were less likely to comply with public health restrictions. People with narcissistic traits had a sense of entitlement and perceived the restrictions as the Government forcing its will upon them.
 
Limitations of the studies

All three studies have limitations, which include being based upon relatively small samples. Data are cross sectional rather than time series and collected at the beginning of public health restrictions when it seems reasonable to assume that “people may be more likely to engage in prevention and adhere to restrictions”. The US and Poland are both developed economies with different cultures that might not be relevant for other regions of the world and, in the case of the two Polish studies, participants were drawn from a relatively homogeneous group.
 
Takeaways

Findings of the three studies described in this Commentary are not sufficiently robust to definitively say that people with narcissistic traits are super-spreaders of CoVID-19. Not everyone who defies coronavirus restrictions does so because of dark personality characteristics. Indeed, there are many factors at play in understanding behaviours during the coronavirus pandemic. Notwithstanding, from the evidence presented in the three papers, it seems reasonable to suggest that people with narcissistic tendencies, and who are asymptomatically infected with the coronavirus, could become super-spreaders and have a disproportionate impact on the transmission of CoVID-19.
 
#coronavirus #pandemic #coVID-19 #narcissism
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4 years, 4 months ago

MedTech must digitize to remain relevant

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Directory:
Medical Technology
Tags:
commentary
coronavirus
coVID-19 pandemic
Internet of Things
IoT
Since we first published this Commentary just over a year ago it’s received over 10,000 views. We’re republishing it  as colleagues have suggested that the digitization of MedTech is more relevant today because of the impact CoVID-19 has had on the industry.
  • Two Boston Consulting Group studies say MedTech innovation productivity is in decline
  • A history of strong growth and healthy margins render MedTechs slow to change their outdated business model
  • The MedTech sector is rapidly shifting from production to solutions
  • The dynamics of MedTechs' customer supply chain is changing significantly and MedTech manufacturers are no longer in control
  • Consolidation among buyers - hospitals and group purchasing organisations (GPO) - adds downward pressure on prices
  • Independent distributors have assumed marketing, customer support and education roles
  • GPO’s have raised their fees and are struggling to change their model based on aggregate volume
  • Digitally savvy new entrants are reinventing how healthcare providers and suppliers work together
  • Amazon’s B2B Health Services is positioned to disrupt MedTechs, GPOs and distributors 
  • MedTech manufacturers need to enhance their digitization strategies to remain relevant
 
MedTech must digitize to remain relevant
 
MedTech companies need to accelerate their digital strategies and integrate digital solutions into their principal business plans if they are to maintain and enhance their position in an increasingly solution orientated healthcare ecosystem. With growing focus on healthcare value and outcomes and continued cost pressures, MedTechs need to get the most from their current portfolios to drive profitability. An area where significant improvements might be made in the short term is in MedTechs' customer facing supply chains. To achieve this, manufacturing companies need to make digitization and advanced analytics a central plank of their strategies.
 
In this Commentary
 
This Commentary describes the necessity for MedTechs to enhance their digitization strategies, which are increasingly relevant, as MedTech companies shift from production to solution orientated entities. In a previous Commentary we argued that MedTechs history of strong growth and healthy margins make them slow to change and implement digital strategies. Here we suggest that the business model, which served to accelerate MedTechs' financial success over the past decade is becoming less effective and device manufacturers need not only to generate value from the sale of their product offerings, but also from data their devices produce so they can create high quality affordable healthcare solutions. This we argue will require MedTechs developing  innovative strategies associated with significantly increasing their use of digital technology to enhance go-to-market activities, strengthen value propositions of products and services and streamline internal processes.
 
MedTechs operate with an outdated commercial model
 
Our discussion of digitization draws on two international benchmarking studies undertaken by the Boston Consulting Group (BCG). The first,  published in July 2013 and entitled, “Fixing the MedTech Commercial  Model: Still Deploying ‘Milkmen’ in a Megastore World” suggests that the high gross margins that MedTech companies enjoy, particularly in the US, hide unsustainable high costs and underdeveloped commercial skills. According to BCG the average MedTech company’s selling, general and administrative (SG&A) expenses - measured as a percentage of the cost of goods sold -  is 3.5 times higher than the average comparable technology company. The study concludes that MedTechs' outdated business model, dubbed the “milkman”, will have to change for companies to survive. 
 
BCG’s follow-up 2017 study
 
In 2017 BCG published a follow-up study entitled, “Moving Beyond the ‘Milkman’ Model in MedTech”, which surveyed some 6,000 employees and benchmarked financial and organizational data from 100 MedTech companies worldwide, including nine of the 10 largest companies in the sector. The study suggested that although there continued to be downward pressure on device prices, changes in buying processes and shrinking gross margins, few MedTech companies “have taken the bold moves required to create a leaner commercial model”.
 
According to the BCG’s 2017 study, “Overall, innovation productivity [in the MedTech sector] is in decline. In some product categories, low-cost competitors - including those from emerging markets - have grown rapidly and taken market share from established competitors. At the same time, purchasers are becoming more insistent on real-world evidence that premium medical devices create value by improving patient outcomes and reducing the total costs of care”. The growth and spread of value-based healthcare has shifted the basis of competition beyond products, “toward more comprehensive value propositions and solutions that address the entire patient pathway”. In this environment, MedTechs have no choice but to use data to deliver improved outcomes and a better customer experience for patients, healthcare providers and payers.
 
MedTech distributors increasing their market power and influence
 
Although supply chain costs tend to be MedTechs' second-highest expense after labour, companies  have been reluctant to employ digital strategies to reduce expenses and increase efficiencies. As a consequence, their customer supply chains tend to be labour intensive relationship driven with little effective sharing of data between different territories and sales teams. Customer relations are disaggregated with only modest attention paid to patients and payors and insufficient emphasis on systematically collecting, storing and analysing  data to support value outcomes.  
As MedTech manufacturers have been slow to develop strong and effective data strategies, so MedTech distributors have increased their bargaining power through M&As and internationalisation. Some distributors have even assumed marketing, customer support and education roles, while others have launched their own brands. MedTechs' response to these changes has been to increase their direct sales representatives. However, consolidation among buyers - hospitals and GPO’s -  and the extra downward pressure this puts on prices, is likely to make it increasingly costly for MedTechs to sustain large permanent sales forces. 

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Advantages of distributors but no way to accurately measure sales performance

Notwithstanding, the distributor model is still common with MedTechs and has been successful in many markets for a long time. Independent distributors are often used when producers have small product portfolios. In smaller markets, distributors are employed primarily to gain economies of scale as they can combine portfolios of multiple companies to create a critical mass opportunity and  obtain better and faster access to markets.
 
MedTechs have a history of investing in sales force effectiveness (SFE) typically to increase the productivity of sales representatives. Sales leaders have some indication that this pays-off through incremental revenue growth and profits, but they struggle to assess the true performance of such investments not least because SFE includes a broad range of activities and also it is almost impossible to obtain comparative competitor data.
 
Changing nature of GPOs
 
GPO’s also have changed. Originally, they were designed in the early 20th century to bring value to hospitals and healthcare systems by aggregating demand and negotiating lower prices among suppliers. Recently however they have raised their fees, invested in data repositories and analytics and have been driving their models and market position beyond contracting to more holistic management of the supply chain dynamics. Notwithstanding, many GPO’s are struggling to change their model based on aggregate volume and are losing purchasing volume amid increasing competition and shifting preferences.
 
New entrants
The changing nature of MedTechs' customer supply chain and purchasers increasingly becoming concerned about inflated GPO prices have provided an opportunity for data savvy new entrants such as OpenMarkets. The companyprovides healthcare supply chain software that stabilizes the equipment valuation and cost reduction and aims to reinvent how healthcare providers and suppliers work together to improve the way healthcare equipment is bought and sold. OpenMarkets’ enhanced data management systems allow providers to better understand what they need to buy and when. The company represents over 4,000 healthcare facilities and more that 125 equipment suppliers; and provides a platform for over 32,000 products, which on average sell for about 12% less than comparable offerings. In addition, OpenMarkets promotes cost efficiency and price transparency as well as stronger collaboration between providers and suppliers.
 
Amazon’s B2B Health Services
 
But potentially the biggest threat to MedTech manufacturers, GPOs and distributors  is Amazon’s B2B Health Services, which is putting even more pressure on MedTechs to rethink their traditional business models and to work differently with healthcare providers and consumers. With a supply chain in place, a history of disrupting established sectors from publishing to food and a US$966bn market cap, Amazon is well positioned to disrupt healthcare supply chain practices, including contracting. In its first year Amazon’s B2B purchasing venture generated more than US$1bn and introduced three business verticals: healthcare, education and government. Already, hundreds of thousands of medical products are available on Amazon Business, from hand sanitizers to biopsy forceps. According to Chris Holt, Amazon’s B2B Health Services program leader, “there is a needed shift from an old, inefficient supply chain model that runs on physical contracts with distributors and manufacturers to Amazon's marketplace model”.

“If you look at the way a hospital system or a medical device company cuts purchase orders, identifies suppliers, shops for products, or negotiates terms and conditions, much of that has been constrained by what their information systems can do. I think that has really boxed in the way that companies’ function. Modern business and the millennials coming into the workplace, can’t operate in the old way,” says Holt.

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Millennials are used to going to Amazon and quickly finding anything they need; even the most obscure items. According to Holt, “A real example is somebody who wants to find peanut butter that is gluten-free, non-GMO, organic, crunchy and in a certain size. And they want to find it in three to five clicks. That’s the mentality of millennial buyers at home, and they want to be able to do the same things at work. . . . The shift from offline traditional methods to online purchasing is very significant. It is our belief that the online channel is going to be the primary marketplace for even the most premium of medical devices in the future. That trend is already proven by data. So, we’ve created a dedicated team within Amazon Business to enable medical product suppliers to be visible and participate in that channel.”
MedTechs fight back
 
According to the two BCG reports, MedTech companies can fight back by using digital technologies to strengthen and improve their go-to-market activities. This, according to BCG, would enhance MedTechs' connectivity with their customers and help them to learn more about their needs. Indeed, employing digitization to improve customer-facing activities could help standardise order, payment and after-sales service behaviour by defining and standardizing terms and conditions. This could provide the basis to help MedTechs increase their access to a range of customers - clinicians, institutions, insurers and patients - and assist them to tailor their engagements to the personal preferences of providers and purchasers. This could provide customers with access to product and service information at anytime, anywhere and could form the basis to implement broader digitalized distribution management improvements, which focus on value-based affordable healthcare in the face of escalating healthcare costs and variable patient outcomes.
 
Predictive models
 
Many companies use predictive-modelling tools to forecast demand and geo-analytics to speed delivery and reduce inventories. Online platforms provide customers with an easy way to order products and services, transparently follow their shipping status and return products when necessary. Barcodes and radio-frequency identification (RFID) chips, which use electromagnetic fields to automatically identify and track tags that contain electronically stored information attached to products, help customers track orders, request replenishments and manage consignment stock.
 
Back-office improvements
 
Further, the 2017 BCG study suggests that MedTechs only have made limited progress in improving their back-office operations. Many manufacturers  have more employees in their back offices than they do in their customer-facing functions and fail to leverage economies of scale. There is a significant opportunity for MedTechs to employ digital strategies to enhance the management of their back-office functions, including centralizing certain activities that are currently conducted in multiple individual countries.
 
Takeaway
 
For the past decade MedTech manufactures have been slow to transform their strategies and business models and still have been commercially successful. Some MedTech companies are incorporating digital capabilities into their products by connecting them to the Internet of Things (IoT), which potentially facilitate continuous disease monitoring and management. Notwithstanding, such efforts tend to be isolated endeavours - “one-offs” - and are not fully integrated into companies’ main strategies. This could run the risk of MedTech executives kidding themselves that they are embracing digitization while underinvesting in digital technologies. The two BCG studies represent a significant warning since digitization is positioned to bring a step-change to the MedTech sector, which potentially could wound successful manufacturers if they do not change.
 
Post scriptum
 
CoVID-19 has forced MedTechs to temporarily digitize their sales and marketing strategies as doctors and hospitals have restricted physical access, but still many MedTech companies look forward to returning to their single rep-based go-to market strategy when the coronavirus crisis is over. The question MedTechs need to ask themselves is, “Do our customers think that digital means of receiving sales and marketing information are significantly more effective and therefore should become permanent?”.
 

#COVID19 #pandemic #coronavirus #MedTech #internetofthings #IoT
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4 years, 5 months ago

Nonadherence to prescribed medication: an orphan killer epidemic

HealthPad
Directory:
Healthcare
Tags:
commentary
long term conditions
LTCs
nonadherence
  • Nonadherence to medication is a vast and rapidly growing killer epidemic
  • The epidemic is under reported, under-treated and costs healthcare systems billions
  • No healthcare stakeholder has assumed responsibility for reducing the burden of nonadherence and so it has become an orphan issue
  • Psychological techniques used by policy makers have been shown to change peoples’ behaviours, improve healthcare and reduce costs
  • The proliferation of smartphones embedded with behavioural techniques designed to coax people to adhere to medications holds promise
  • But recent research suggests that thousands of apps devised to reduce nonadherence use behavioural techniques sub-optimally
  • There is an opportunity to significantly improve nonadherence to medication by optimally utilising behavioural techniques and digital technology
  • The challenge needs to be embraced by all healthcare stakeholders
 
Nonadherence to prescribed medication: an orphan killer epidemic
 
Nonadherence to prescribed medication for patients with chronic long-term conditions (LTCs) is an out-of-control epidemic, which is undetected and undertreated. It kills hundreds of thousands, erodes the life chances of millions, costs billions and is one of the biggest obstacles to effective healthcare in the 21st century. According to the World Health Organization (WHO), “increasing the effectiveness of adherence interventions may have far greater impact on the health of the population than any improvement in specific medical treatments”.
 
There are a number of reasons why people with LTCs stop taking their medication, which include: (i) fear of potential side-effects, (ii) lack of understanding because taking a medication every day to reduce the risk of something bad happening can be confusing, (iii) failure to see immediate improvement, (iv) too many medications that often cannot be taken at the same time, (v) patients who are depressed are less likely to take their medications as prescribed, (vi) concerns about becoming dependent on a medicine and (vii) high drug costs, particularly in the US.
 
No healthcare stakeholder - patients, doctors, carers, regulators, pharmacists, pharmaceutical companies and healthcare providers – has made nonadherence a priority, so it has become an orphan issue. We suggest that all health stakeholders have a role to play in nonadherence and would benefit  by employing psychological techniques designed to encourage people to change their behaviour. 
 
In this Commentary

Because nonadherence to medication has a significant prevalence in people living with LTCs, we begin this Commentary by describing the vast and rapid growth of LTCs and their associated eyewatering costs. The management of LTCs rests with primary care doctors, but the average doctor-patient consultation is just a few minutes and more importantly, the majority of patients do not remember most of the information provided in such consultations. Not only do primary care doctors have little time to prescribe and explain medication regimes, there is little incentive for them to address nonadherence. We raise the question of whether doctors might be part of the problem by  citing a seminal paper published in The Lancet in 1974, which suggests that doctors have a propensity to medicalise healthcare and over-prescribe medicines. This can transform reasonably healthy people into habitual patients. We then describe a trend gaining momentum both in the US and the UK, whereby community-based pharmacists are becoming a healthcare destination and are well positioned to play a significant role in denting the nonadherence epidemic.  We draw passing reference to pharmaceutical companies’ interest in reducing nonadherence. We conclude by describing a number of research studies, which examine the confluence of mobile telephony and advances in behavioural science, which facilitate the increased use of apps embedded with behavioural techniques to address nonadherence to prescribed medication. Despite the large and growing use of such apps, studies suggest that the use of behavioural techniques in mobile applications to address nonadherence is sub-optimal. Thus, there remains an  opportunity for using advances in behavioural theory and practice to promote sustained and significant lifestyle behaviour changes designed  to reduce the nonadherence to prescribed medication epidemic.
 
Impact of LTCs in the US and UK
 
LTCs, e.g. diabetes, chronic obstructive pulmonary disease (COPD), arthritis and hypertension, are diseases for which there is currently no cure and they are managed with drugs and other treatments. Each year in the US, LTCs affect about 133m people and this is projected to rise to 157m by 2025. According to a 2012  study published in the Annals of Internal Medicine, people who take prescription medicines for LTCs typically only take about half of the prescribed doses. The study’s findings were updated to estimate costs in US dollars to reflect inflation for 2016 prices and published in the March 2018 edition of theAnnals of Pharmacotherapy. The authors estimated that the, “annual cost of drug-related morbidity and mortality resulting from nonoptimized medication therapy was US$528.4bn, equivalent to 16% of total US healthcare expenditures in 2016”.  This compared to 8% and 13% in 1995 and 2008, respectively. Although this estimate accounts for overall price inflation, it does not include non-medical or indirect costs, such as lost productivity or caregiver expenses, which have been estimated to be more than the direct medical costs for many LTCs. Also, the authors estimated that nonadherence results in about 275,689 deaths each year. 

In the UK nonadherence to prescribed medication among people with LTCs has a similar impact. According to a 2014 UK House of Common’s Health Committee report, “Effectively managing LTCs is widely recognised to be one of the greatest challenges facing the 21st-century”.  Seventy percent of total expenditure on healthcare in England is associated with the treatment of the 30% of the population with one LTC or more, and the number of people in England with one or more such condition - currently 15m - is projected to increase to around 18m by 2025. Care for LTCs presently accounts for 55% of primary care doctors’ appointments, 68% of outpatient and A&E appointments and 77% of inpatient bed days. The cost to NHS England of people with LTCs not taking their prescribed medicines appropriately and thereby not getting the full benefits to their health is estimated at more than £500m (US$635) a year, with a further cost of £300m (US$381) on wasted medication.
 
Nonadherence is not a doctor’s problem

Despite the fact that a medical consultation is a complex and multidimensional process, which is pivotal to the health of patients, the average time spent for each consultation is short and there is little or no time for doctors to educate or motivate patients. A 2017 paper published in the British Medical Journal (BMJ) reviewed 28.6m doctor-patient consultations across 67 countries and found that, in 18 countries, which represented about 50% of the global population, on average a doctor-patient consultation is five minutes or less. On average, British patients spend just over nine minutes with their primary care doctor  during an appointment and in the US, it is  17 minutes. More significantly, a 2016 study published in Health Expectations, suggested that patients only remember about a fifth of the information discussed in a standard doctor-patient consultation.
In addition to time constraints there is little incentive for doctors to address nonadherence. In the US, fee-for-service medicine incentivizes services, not improved outcomes. Although this is changing as insurers pay for value rather than activity, pay-for-quality programmes tend to be too small to motivate busy doctors. Similarly, the UK’s public healthcare system, which is free at the point of care for all citizens, lacks incentives for health professionals to be overly concerned about nonadherence to medication. Primary care doctors view their primary responsibility as making an accurate diagnosis followed by an appropriate prescription and generally tend to be unaware of the magnitude of nonadherence to medication.

 

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The medicalization of health

Compounding the problem of nonadherence is the medicalization of healthcare, which can transform healthy people into patients. This was graphically described by Ivan Illich, in a seminal paper entitled “Medical Nemesis” published in 1974 in The Lancet. The same year, Illich published a book with the same title, which opens with the sentence, “The medical establishment has become a major threat to health”. Illich continued, “The disabling impact of professional control over medicine has reached the proportions of an epidemic”, which Illich referred to as an iatrogenic  epidemic:  derived from the Greek word “iatrogenesis” (ιατρογένεση), which means “originating from a physician or treatment”.
 
Healthy people transformed into patients

In a similar vein, a paper entitled “Let’s not turn elderly people into patients” and published in the May 2009 edition of the  British Medical Journal, suggested that annual health checks, which primary care doctors are incentivized to carry out, can transform reasonably healthy older people into habitual patients. The author, Michael Oliver, Professor Emeritus of Cardiology at the University of Edinburgh, suggested  that doctors view people over 70 to be at risk of one or other LTC and insist on medical checks. These  can lead to reasonably healthy individuals being told that they have high cholesterol levels or hypertension etc. and prescribed regular medications, instead of being encouraged, in the first instance, to exercise more and adopt healthier diets and lifestyles. Thus, a number of elderly people who considered themselves healthy on the way to the doctors, return home as patients. “What kind of medicine is this?” asks Oliver rhetorically, and answers, “It is politics taking preference over professionalism, obsession with government targets superseding common sense, paternalism replacing personal advice. It seems that many Western governments regard all people aged over 75 as patients”. And such perceptions can lead to over testing, over diagnoses and over treatment.
 
Pharmacists becoming significant healthcare destinations

Over the past decade pharmacists and pharmacies have been increasingly viewed as underutilised assets well positioned to improve nonadherence. In both the US and UK retail community pharmacies are accessible on a walk-in basis, without the need for an appointment. Pharmacists are the last checkpoint before a patient takes their medication and are therefore available to provide personalized advice about health and medicine to millions of people.
 
In the US there are approximately 314,300 pharmacists, and some 67,000 pharmacies; half of which (33,000) are conveniently located within drug stores, grocery stores, department stores, primary care clinics, universities, nursing homes, hospitals and prisons. In 2019, over 4.4bn retail prescriptions were filled throughout the US. Similarly, in England, there are some 42,990 registered pharmacists; 32,000 of whom work in 11,700 community pharmacies. Every day in England, approximately 1.6m people visit a pharmacy and for 89% of them a community pharmacy is within a 20-minute walk from where they live. Each year community pharmacies in England dispense over 1bn prescriptions.
 
The fact that pharmacists are rapidly evolving from a focus on product preparation and dispensing to becoming significant healthcare destinations is welcomed by both the UK’s Royal Pharmaceutical Society (RPS), the Royal College of General Practitioners (RCGP) and NHS England. Three 2016 reports demonstrate this: two published by the RPS and one published jointly by the RCGP and NHS England.  In September 2016, a RPS report entitled, Community Pharmacy Forward View, set out a vision to expand and improve pharmacy services by: (i) facilitating personalised care for people with LTCs, (ii) acting as a trusted, convenient first-port-of-call for healthcare advice and treatment, and (iii) providing a hub for neighbourhood health and wellbeing. The report was complemented by another, published in November 2016, entitled Frontline pharmacists: Making a difference for people with long term conditions, which argued that the expertise and clinical knowledge of pharmacists must be fully utilised to support people with LTCs and help them to achieve the desired outcomes from their medicines, thereby making more efficient use of NHS England’s resources. Such views were echoed in the General Practice Forward View, a report published in April 2016 by the RCGP and NHS England. The report suggested that pharmacists were, “one of the most underutilised professional resources in the [healthcare] system” and suggested that there was a need to, “bring their considerable skills into play more fully” and promote the need for pharmacists to be part of the broader health practice team.

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Pharmaceutical companies

Pharmaceutical companies have an incentive to reduce nonadherence with innovative solutions. When patients fail to take their prescribed medications, not only does their health deteriorate and health providers lose money, but doctors often change medications. This translates in a potential loss to the pharmaceutical company. Some experts estimate nonadherence in the US costs the pharmaceutical industry US$30bn a year in lost revenues, which others suggest is the tip of the iceberg.
Apps using behavioural techniques to reduce nonadherence

Over the past two decade, reducing nonadherence to medication has sought solutions in smartphone apps embedded with psychological techniques to encourage users to change their behaviour. Recent studies suggest that 90% of total time on mobile phones is being spent on apps and individuals may spend an average of 30 hours per month on apps. Such preoccupation raises the possibility that apps could be utilized by healthcare providers and their patients to reduce nonadherence.
 
Behavioural science’s  signature policy is set out in the 2008 book  ‘Nudge’, which looks at how people make decisions and applies this to healthcare. Nudges are a particular type of behaviour change intervention, which steer people in certain directions while maintaining their freedom of choice. The key insight is that changing the way choices are presented to people can have a significant impact. We end this Commentary by briefly describing some studies that have examined apps embedded with ‘nudge’ techniques to address the nonadherence to medication challenge. But first, we describe the rise in the influence of behavioural techniques in health policy.
 
The rise in the influence of behavioural techniques on health policy

In the early 2000s, both the US and UK governments began to explore how psychological and behavioural techniques could be used to improve public policy and healthcare, while maintaining a significant element of personal choice. In 2003, policy makers in the US were influenced by a paper entitled ‘Libertarian Paternalism’, published in the American Economic Review. Its authors, Richard Thaler, a University of Chicago economist and Cass Sunstein, a Harvard University  Law School professor, suggested that it is both possible and legitimate for private and public institutions to influence people to make decisions about health and wellbeing without coercing them. In February 2004, the UK’s Prime Minister’s Strategy Unit, published a report entitled ‘Personal Responsibility and Changing Behaviour: the state of knowledge and its implications for public policy’, which described behavioural theories of change  and explored ways the government might employ psychological techniques to influence personal behaviour in order to improve public policy. In 2008, Thaler and Sunstein published a book entitled ‘Nudge’, which described how behavioural techniques and mental processes could be used to ‘nudge’ people and groups, rather than ordering them, to do things expected to improve public policy and reduce costs. In 2009, the US government recruited Sunstein to head the Office of Information and Regulatory Affairs (OIRA) and streamline regulations. In 2010, UK Prime Minister David Cameron established the Behavioural Insights Team (BIT) (referred to as the ‘Nudge Unit’) in 10 Downing Street, which was headed by David Halpern, the first author of the 2004 Strategy Unit Report referred to above. This was the first formal and systematic application of behavioural insights to public policy. In 2014,  President Obama set up a similar unit - the Social and Behavioral Sciences Team - in the White House. Over the past decade, similar units have been set up by governments throughout the world, the word “nudge” and ‘Nudge Units’ have become common place in social and public policy, and the application of behavioural techniques, have become a significant aspect of public sector management. Nudge techniques  have been employed to reduce the burden of nonadherence to medication.
 
Apps to nudge people to adhere to medication

Over the past decade, there has been a plethora of apps launched to tackle nonadherence to medication. A December 2015 study published by the UK’s Health Foundation entitled Behavioural Insights in Healthcare, suggested that “nudge-type” interventions could, “improve rates of medication adherence, particularly for chronic conditions”. In September 2018, Public Health England published a similar report entitled, Improving People’s Health: Applying behavioural and social sciences to improve population health and wellbeing in England. These and other studies reflect the prominence gained in recent years of the potential benefits behavioural and social sciences can make to improving peoples’ health.
 
Limited use of ‘nudge’ techniques

A research paper entitled, “Behavior Change Techniques in Apps for Medication Adherence” published in the May 2016 edition of the American Journal of Preventative Medicine drew attention to the vast and growing number of apps promoting medication adherence available in the two largest app repositories: the Apple App Store and the Google Play Store. The authors identified and coded 166 medication adherence apps according to 96 established behaviour change techniques and found that the apps only used a limited number of these, and “do not appear to have benefitted  from advances in the theory and practice of health behaviour change”. The most commonly included behaviour change techniques were “action planning” and “prompt/cues,” which were included in 96% of apps, followed by “self-monitoring” (37%) and “feedback on behaviour” (36%). The authors of the study concluded that the apps did not appear to have benefitted from “advances in the theory and practice of health behavioural change”.
 
Four research studies conclude that apps are using behavioural techniques sub-optimally

Four research papers published between 2017 and 2020 in the Journal of Medical Internet Research assessed thousands of apps embedded with behavioural techniques to address medication adherence in different regions of the world and all reached similar conclusions to the 2016 paper in the American Journal of Preventative Medicine mentioned above: that apps designed to enhance medication adherence use ‘nudge’ techniques sub-optimally.
 
In the April 2017 edition of the Journal of Medical Internet Research, a paper entitled “Assessing the Medication Adherence App Marketplace from the Health Professional and Consumer Vantage Points”, identified  824 adherence apps and evaluated 645 of them. Researchers found that the quality of the apps “varied considerably”.  A 2018 review paper published in the same journal,  provided one of the first comprehensive assessments of medication adherence apps in terms of their evidence base, medical professional involvement in their development and the strategies they used to facilitate behaviour change and improve adherence. Researchers identified 5,881 apps, tested 1,486 according to predetermined criteria and concluded that there was, “a concerning lack of healthcare professional involvement in app development and evidence base of effectiveness”.  
 
A paper entitled, “Using Health and Well-Being Apps for Behavior Change” published in the July 2019 edition of the Journal of Medical Internet Research, provides a systematic review of a large sample of healthcare apps marketed in Australia. The initial search identified 212,352 apps, from which 5,018 were identified using a priori key search terms.  Of these, 344 were classified as behaviour change apps and were reviewed and rated. Conclusions suggested that only a limited number of the apps were found to be using behavioural change techniques expected to promote and sustain lifestyle behavioural change and improved health. 
 
And finally, a research paper entitled, “Quality, Functionality, and Features of Chinese Mobile Apps for Diabetes Self-Management: Systematic Search and Evaluation of Mobile Apps” published in the April 2020 edition of the Journal of Medical Internet Research evaluated apps that are available to millions of people in China living with diabetes and designed to help them self-manage essential medications they are required to take regularly throughout their lives. Among 2,072 apps identified, 199 were selected based on the authors’ criteria and 67 apps were analysed.  Conclusions were similar to those in the previous studies mentioned in this section and suggested that the, “general quality” of the apps was “sub-optimal”.
 
Takeaways
 
Nonadherence to medication is a vast and rapidly growing killer epidemic, which is under reported, under-treated and cost healthcare systems billions. This is partly because no healthcare stakeholder has assumed responsibility for denting the burden of the epidemic. Thus, nonadherence is an orphan issue. More recently, the confluence of mobile telephony and behavioural techniques has held out a promise to reduce nonadherence. However, research has suggested that while there is a proliferation of mobile apps embedded with behavioural techniques specifically designed to lower the burden of nonadherence to medication, the overwhelming majority of these are not using tried and tested behavioural techniques optimally. This suggests that there is an opportunity to significantly improve nonadherence to medication by optimally utilising behavioural techniques and digital technology.
 
#LongTermConditions #nonadherence #nonadherencetomedication #behaviouraltechniques #Nudge
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